Final Report

Select Investigative Panel

of the Energy & Commerce Committee
December 30, 2016

Select Investigative Panel

of the Energy & Commerce Committee
__________________________________________________________________

Select Investigative Panel

Final Report
Rep. Marsha Blackburn (TN-7)
Chairman

Rep. Joseph Pitts (PA-16)

Rep. Diane Black (TN-6)
Rep. Larry Bucshon (IN-8)
Rep. Sean Duffy (WI-7)
Rep. Andy Harris (MD-1)
Rep. Vicky Hartzler (MO-4)
Rep. Mia Love (UT-4)

Table of Contents
Executive Summaries....................................................................................................... xviii
Preface............................................................................................................................... xliv
Acknowledgments............................................................................................................... lvi
I. Congress Establishes the Select Investigative Panel .............................................................1
A. Summary .............................................................................................................................1
B. Center for Medical Progress Videos Raise Serious Issues .............................................3
1. Planned Parenthood Orange County Changes Abortions to Harvest Intact Fetuses
for Local Companys Fetal Products sales ................................................................3
2. Planned Parenthood Ally National Abortion Federation Suggests Group
Purchasing Program for Fetal Parts, Payments A Win-Win for Clinics ..................4
3. Planned Parenthood Houston Admits Accounting Gimmicks Hide Baby Parts
Sales, Invoices Charge Thousands of Dollars ..............................................................4
4. Planned Parenthood TX Abortion Apprentice Taught Partial-Birth Abortions to
Strive For Intact Baby Brains ....................................................................................4
5. Top Planned Parenthood Exec Agrees Baby Parts Sales A Valid Exchange,
Some Clinics Generate a Fair Amount of Income Doing This .................................4
6. Planned Parenthood Baby Parts Vendor Advanced Bioscience Resources Pays
Off Clinics, Intact Fetuses Just Fell Out .....................................................................5
7. Planned Parenthood Baby Parts Buyer StemExpress Wants Another 50
Livers/Weeks, Financial Benefits for Abortion Clinics..............................................5
8. Intact Fetuses Just a Matter of Line Items for Planned Parenthood TX MegaCenter ...........................................................................................................................6
9. Planned Parenthood VP Says Fetuses May Come Out Intact, Agrees Payments
Specific to the Specimen ..............................................................................................6
10. Second Planned Parenthood Senior Executive Haggles Over Baby Parts Prices,
Changes Abortion Methods..........................................................................................6
11. Planned Parenthood Uses Partial-Birth Abortions to Sell Baby Parts ......................7
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C. The Panel Forms an Investigative Plan ..........................................................................7

D. Middleman Investigative Work Plan Overview ............................................................11
II. Applicable Laws, Regulations, and Commissions ...............................................................13
A. Laws Protecting Human Research Subjects and Patient Privacy ...............................13
1. The Belmont Report ......................................................................................................13
2. The Common Rule and IRB Regulations .....................................................................15
3. Presidential Commissions .............................................................................................16
4. HIPAA Privacy Rule.....................................................................................................17
B. Laws Regulating Anatomical Gifts for Transplantation, Therapy, Research, and
Education ................................................................................................................................19
1. National Organ Transplant Act ....................................................................................19
2. Uniform Anatomical Gift Act .......................................................................................19
3. NIH Revitalization Act of 1993 ....................................................................................20
C. Laws Protecting Late-Term and Born-Alive Infants ...................................................21
1. Born-Alive Infants Protection Act (BAIPA) ................................................................21
2. Partial-Birth Abortion Ban Act (PBA) .........................................................................23
D. Laws Related to Public Funding of Fetal Tissue Research and Abortion Providers 23
1. NIH Grants ....................................................................................................................23
2. Federal Funding for Abortion Providers .......................................................................24
a) Medicaid ................................................................................................................24
b) Title X ....................................................................................................................27
III. Panel Hearings .....................................................................................................................28
A. Bioethics and Fetal Tissue ...............................................................................................28
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B. The Pricing of Fetal Tissue ..............................................................................................31

IV. Criminal and Regulatory Referrals .....................................................................................33
A. Referral to New Mexico Attorney General concerning University of New Mexico ...35
B. Referrals to U.S. Department of Justice and El Dorado, CA District Attorney
concerning StemExpresss limited production and possible profit from fetal
tissue procurement ...........................................................................................................37
C. Referral to U.S. Department of Health and Human Services concerning the
possible violation of HIPAA by StemExpress and several abortion clinics ................47
D. Referral to U.S. Department of Health and Human Services concerning a
possible violation of IRB regulations by StemExpress .................................................54
E. Referral to the Arkansas Attorney General concerning the possible profit from
fetal donations by an Arkansas abortion clinic .............................................................71
F. Referral to Orange County, CA District Attorney concerning the possible
profit from fetal tissue procurement by DV Biologics ..................................................73
G. Referral to the Texas Attorney General concerning the possible profit from
fetal tissue donations by Planned Parenthood Gulf Coast ...........................................79
H. Referral to the Riverside County, CA District Attorney concerning Advanced
Bioscience Resourcess possible profit from fetal tissue sales to universities .............90
I. Referral to the Florida Attorney General concerning the possible profit from
fetal tissue donations by a Florida abortion clinic ........................................................93
J. Referrals to the U.S. Department of Justice and the Texas Attorney General
concerning a late-term abortionist in Texas ................................................................104
K. Referral to the Attorney General of New Mexico concerning Southwestern
Womens Options and the University of New Mexico ................................................118
L. Referral to the U.S. Department of Justice concerning the destruction of
documents by StemExpress ...........................................................................................124
M. Referral to the U.S. Department of Justice concerning violations of 42 U.S.C.
289g-2 by Novogenix and four Planned Parenthood clinics ...................................134
V. Case Studies of the Fetal Tissue IndustryThe Middleman Model ...............................136
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A. StemExpress, LLC: A Case Study .............................................................................137

1. Summary .....................................................................................................................137
a) Background of StemExpress ................................................................................137
b) History of the Panels Interactions with StemExpress .........................................138
2. StemExpress Business Model .....................................................................................141
a) Marketing Activities ............................................................................................141
b) StemExpress Seeks a Nationwide Network of Abortion Clinics .........................148
c) StemExpress Seeks Partnership Agreement with Planned Parenthood
Federation of America .........................................................................................152
d) StemExpress Contracts with Abortion Clinics ...................................................153
e) Impact of StemExpress Contracts on Clinical Practices ......................................155
3. StemExpress Revenue Grows from $156,312 to $4.5 Million ..................................155
a) StemExpress Estimated Costs and Expenses Indicates That It May Have
Made a Profit........................................................................................................157
b) StemExpress Used Deceptive Trade Practices to Obtain Maternal Blood at
Zero Cost ..............................................................................................................160
4. StemExpress Tissue Technicians Embedded in Planned Parenthood Affiliates: A
Typical Day................................................................................................................161
a) How Researchers Placed an Order .......................................................................162
b) Embedded Tissue Technicians Learn of Next Days Scheduled Abortions ........164
c) Clinic Personnel Gave Tissue Technicians Access to Patients Private
Medical Information ............................................................................................164
d) Embedded Tissue Technicians Obtained Consent from Women to Donate
Fetal Tissue ..........................................................................................................165
i) When it obtained consent from PPFA affiliates, StemExpress used PPFAs
consent form ....................................................................................................166
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ii) StemExpress used its own consent form when it obtained consent from
patients at independent womens clinics........................................................166
e) StemExpress Tissue Technicians Procured the Fetal Tissue ...............................167
i) After they procured the body parts and tissue, StemExpress employees
packaged and shipped them directly to StemExpress customers ....................168
ii) StemExpress tissue technicians had a financial incentive to procure the
most body parts and fetal tissue possible .......................................................169
5. StemExpress Due Diligence ............................................................................................. 172
6. Payments Received by Clinics ...................................................................................173
7. Payments Received by StemExpress for Its Resale of Fetal Tissue ..........................174
8. The Select Panel Recommends that the House Find StemExpress in Contempt of
Congress .....................................................................................................................177
9. StemExpress May Have Violated Federal Laws and Regulations.............................179
a) 18 U.S.C. 1519 ..................................................................................................180
b) 42 U.S.C. 289g-2 ..............................................................................................180
c) California Health and Safety Code Section 125320 ................................................ 181
d) HIPAA .................................................................................................................181
e) HHS Regulations on Informed Consent ..............................................................181
f) HHS Regulations on Coercion .............................................................................182
g) HHS Regulations on Institutional Review Boards...............................................183
h) California Revenue and Tax Code .......................................................................184
10. The Panel Makes Criminal Referrals Based on StemExpress Apparent Violations
of Law and Federal Regulations ................................................................................185
B. DaVinci Biosciences, LLC/DaVinci Biologics, LLC: A Case Study ..........................186
1. Summary ....................................................................................................................186
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a) Background of DaVinci and DVB .......................................................................186

b) History of the Panels Interactions with DaVinci and DVB ................................187
2. Business Model of DaVinci and DVB .......................................................................189
a) Marketing Activities ............................................................................................189
b) DaVinci and DVBs Relationship with Planned Parenthood of Orange and
San Bernardino Counties .....................................................................................192
c) Revenue Growth .................................................................................................194
3. Consent & Procurement During the Abortion Procedure ..........................................194
4. Post-Procedure Practices ............................................................................................195
5. Customers that Received Fetal Tissue from DaVinci and DVB................................195
6. Potential Violations of Law .......................................................................................198
a) Applicable Laws ..................................................................................................198
a) 42 U.S.C. 289g-2 ................................................................................................ 198
b) California Health and Safety Code Section 125320 ........................................... 198
c) California Revenue and Tax Code ...................................................................... 198
b) Findings................................................................................................................200
i) 42 U.S.C. 289g-2 & California Health and Safety Code Section 125320 ..200
ii) California Revenue and Tax Code .................................................................201
7. Conclusion ...................................................................................................................202
C. Novogenix Laboratories, LLC: A Case Study .............................................................203
1. Summary ....................................................................................................................203
a) Background of Novogenix ...................................................................................203
b) History of the Panels Interactions with Novogenix ............................................203
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2. Novogenix Business Model .......................................................................................205

a) Marketing Activities ............................................................................................205
b) Novogenixs Relationship with Abortion Clinics ................................................206
c) Revenue Growth ..................................................................................................206
3. Consent ......................................................................................................................207
4. Procurement ...............................................................................................................209
5. Post-Procurement Practices .......................................................................................210
6. Clinics ........................................................................................................................211
a) Payments received by clinic.................................................................................211
7. Customers that Received Fetal Tissue from Novogenix............................................212
8. Potential Violations of Law .......................................................................................212
a) Applicable Laws & Regulations ..........................................................................212
i) 42 U.S.C. 289g-2 ................................................................................................ 213
ii) California Health and Safety Code Section 125320 ......................................... 213
iii) HHS Regulations on Informed Consent ............................................................. 213
iv) HHS Regulations on Institutional Review Boards (IRBs) .............................. 215
v) California Revenue and Tax Code ...................................................................... 215
b) Findings................................................................................................................216
i) 42 U.S.C. 289g-2 & California Health and Safety Code Section 125320 .. 216
ii) HHS Regulations on Informed Consent ............................................................. 217
iii) HHS Regulations on IRBs .................................................................................... 218
iv) California Revenue and Tax Code ...................................................................... 218
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9. Conclusions ......................................................................................................................... 220

D. Advanced Bioscience Resources, Inc. ................................................................................ 220
1. Summary ....................................................................................................................220
a) Background of ABR ............................................................................................220
b) History of the Panels Interactions with ABR .....................................................220
2. ABRs Business Model ..............................................................................................221
3. ABR Payments to Abortion Clinics ...........................................................................222
4. ABR Revenue from Customers .................................................................................223
5. ABR May Have Violated Federal and State Laws and Regulations ........................225
E. Human Fetal Tissue Repository ..................................................................................226
1. Summary ....................................................................................................................226
a) Background of the Human Fetal Tissue Repository ................................................ 226
b) History of the Panels Interactions with HFTR ........................................................ 227
2. Hospitals from which HFTR Procured Fetal Tissue ..................................................228
3. Procurement Process ..................................................................................................228
4. Researchers that Received Fetal Tissue from HFTR .................................................229
5. Conclusions ................................................................................................................230
VI.

Case Studies of the Fetal Tissue IndustryThe University/Clinic Model ...............231

A. Summary .........................................................................................................................234
B. The University of New Mexico, Southwestern Womens Options, and Planned
Parenthood ................................................................................................................................ 235
1. Summary ...................................................................................................................235
2. The University of New Mexico Becomes an Abortion Provider ...............................236
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3. UNM Provides Doctors to Southwestern Womens Options and Planned

Parenthood .................................................................................................................238
4. UNM Confers Faculty Status and Benefits upon SWWO Personnel ........................240
5. UNM Performs Research Using Tissue from Infants Aborted at SWWO and
Shares the Tissue with Other Research Entities ........................................................242
6. UNM and SWWOs Failure to Properly Obtain Consent ..........................................246
7. The Panels Criminal Referrals of UNM and SWWO...............................................248
a) The June 2016 Referral ........................................................................................248
b) The December 2016 Referrals .............................................................................250
C. The University of Washington and the Nations Largest Fetal Tissue Bank ............ 253
1. Summary ....................................................................................................................253
2. The University of Washington, in Conjunction with Numerous Clinics,
Establishes the Nations Largest Fetal Tissue Bank ..................................................253
3. The Sharing of Personnel Between UW and Outside Clinics That Supply Tissue ...255
4. Fetal Tissue Research at UW BDRL .........................................................................258
5. UWs Productions Were Insufficient for the Panel to Conduct a Full Analysis of
UWs Fetal Tissue Transactions ................................................................................258
D. Planned Parenthood Gulf Coast: A University Case Study .......................................260
1. Summary ....................................................................................................................260
a) Background on Planned Parenthood Gulf Coast .................................................260
b) History of Panels Interactions with PPGC and Related Entities ........................261
2. PPFA Policy on Reimbursement for Fetal Tissue Donation Programs .....................262
a) April 2001 PPFA memorandum ..........................................................................262
b) January 2011 redistribution of PPFA memo ........................................................263
3. PPGC Relationship with University of Texas Medical Branch .................................263
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a) PPGC Procures Fetal Tissue for UTMB ..............................................................264

4. PPGCs Relationship with Baylor College of Medicine............................................268
5. Potential Violations of Law .......................................................................................270
a) Applicable Laws ..................................................................................................270
i) 42 U.S.C. 289g-2 ................................................................................................ 270
ii) Texas Penal Code 48.02 .................................................................................... 270
iii) Texas Penal Code 37.08 .................................................................................... 270
6. Findings......................................................................................................................271
a) 42 U.S.C. 289g-2 & Texas Penal Code 48.02 ...............................................271
b) Texas Penal Code 37.08 ....................................................................................271
E. The University of Minnesota ........................................................................................272
F. Colorado State University .............................................................................................273
G. University of California at San Francisco ...................................................................274
H. Washington University and Planned Parenthood of St. Louis ..................................275
I. University of Wisconsin .................................................................................................276
J. University of Michigan ..................................................................................................277
VII. Case Studies of Late-Term Abortion Clinics..................................................................280
A. Summary .........................................................................................................................281
B. [Abortion Doctor #1] .....................................................................................................282
1. Background on [Abortion Doctor #1] .......................................................................282
2. The Panel Issues a Subpoena to [Abortion Doctor #1] .............................................282
3. The Panels Investigation into the Clinic in Maryland ..............................................283
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C. [Abortion Doctor # 2] ....................................................................................................284

1. Background on [Abortion Doctor #2] ........................................................................284
2. The Panels Investigation into [Abortion Doctor #2] ................................................285
D. [Abortion Doctor #3] .....................................................................................................285
1. Summary ....................................................................................................................285
2. Allegations Against [Abortion Doctor #3] ...............................................................286
3. Violations of Applicable Laws ..................................................................................289
E. University of New Mexico and Southwestern Womens Options ..............................292
VIII. Case Studies of the Fetal Tissue Industry Planned Parenthood ..............................297
A. Summary ..........................................................................................................................298
B. Planned Parenthood: A Corrupt Founding .................................................................298
C. Planned Parenthood: Problems with the Business Model ..........................................301
D. PPFA Affiliate Relationship .......................................................................................306
E. Planned Parenthood Federation Failure to Ensure Compliance by Affiliates with
Legal Billing Practices; Federal Law Governing Fetal Tissue Donation Projects;
Federally Required Affirmation about Changing Abortion Procedures; Patient
Consent; and HIPAA Regulations ...................................................................................... 309
1. Summary .............................................................................................................................. 309
2. Planned Parenthood: Failure to Properly Steward Federal Funds .............................310
3. Recent History of Planned Parenthood Audits ..........................................................311
4. Summary Details of the Known Audits of Planned Parenthood Affiliates ...............314
a) California Audits .......................................................................................... 314
i) California Audit I San Diego and Riverside Counties, 2004........................ 314
ii) California Audit II Golden Gate, 2010 .................................................................. 314
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b) Connecticut Audit ................................................................................................314

c) Illinois Audit ........................................................................................................315
d) Louisiana Audit ....................................................................................................315
i) Louisiana Audit I ................................................................................................... 315
ii) Louisiana Audit II 2014 ..................................................................................... 315
e) Maine Audit .........................................................................................................315
f) Nebraska Audit ....................................................................................................316
g) New York Audits .................................................................................................316
i) New York Audit I New York City, January 2009 ................................................. 316
ii) New York Audit II Hudson Peconic, June 2009 ................................................... 316
iii) New York Audit III New York City, June 2009 ................................................... 316
iv) New York Audit IV New York City, December 2009 .......................................... 316
v) New York Audits V-VII February/May 2010 ....................................................... 317
h) Oklahoma Audits .................................................................................................317
i) Texas Audits ........................................................................................................317
i) Texas Audit I ..................................................................................................317
ii) Texas Audit II ................................................................................................317
j) Washington State Audits......................................................................................318
i)

Washington Audit I ........................................................................................318

ii) Washington Audit II Inland Northwest, 2007-2009 ...................................318

iii) Washington Audit III Great Northwest ......................................................318
k) Wisconsin Audits .................................................................................................318
5. Conclusion .................................................................................................................319
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6. Compliance with Federal Law Governing Fetal Tissue Donation Programs ............319
7. Planned Parenthood Clinics Profited from the Sale of Fetal Tissue .........................322
8. The Panel Investigates Planned Parenthood Affiliate Clinics ...................................323
9. PPFA Affiliates and StemExpress Claim the Same Expenses...................................327
10. Planned Parenthood Production Schedule of their Costs Associated with Fetal
Tissue Donation .........................................................................................................330
11. The Planned Parenthood Cost Documents Are Unsupported ...................................332
12. Comparison of Costs Claimed by Planned Parenthood Affiliates and Expenses
Claimed by Fetal Tissue Middleman StemExpress ...................................................336
13. Planned Parenthood Affiliates Cost Schedules Compared to the Defined
Allowable Costs in 42 U.S.C. 289g-2 .....................................................................337
14. Job Descriptions of Planned Parenthood Staff do not Include any Reference to
Tasks or Responsibilities Associated with Fetal Tissue ...........................................348
F. Changing the Method of Abortion Procedure to Obtain More Fetal Tissue ............ 352
1. Changing the Presentation of the Baby to Harvest a Calverium ...............................353
2. Abortion Doctor and Contract Tissue Technician Communicate Prior to the
Abortion Procedure ....................................................................................................355
3. Training of Clinic Personnel and Doctors is Required to Improve the Likelihood
of Intact Tissue from an Abortion ..............................................................................355
4. Panel Interviews Consistent with the CMP Undercover Videos ...............................356
G. Planned Parenthood Affiliates Violated the Federal Guidelines on Patient
Consent............................................................................................................................360
1. Summary ....................................................................................................................360
2. Legal Background ......................................................................................................360
3. The Panel asks experts to evaluate Planned Parenthoods consent form...................361

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4. Planned Parenthoods consent form is inadequate compared to other entities

consent forms .............................................................................................................362
5. The Planned Parenthood consent form does not indicate whether the tissue will
be used for education, research, or treatment, including transplantation...................363
6. PPFA Executive suggests that the middleman obtain the consent to donate tissue...364
E. StemExpress and Planned Parenthood abortion clinics appear to have
committed systematic violation of HIPAA ..................................................................365
1. Summary ....................................................................................................................365
2. Legal Background ......................................................................................................366
3. Factual Background ...................................................................................................366
4. The Contracts between StemExpress and the Planned Parenthood abortion
clinics .........................................................................................................................368
5. Violations of the HIPAA Privacy Rule by StemExpress and the Planned
Parenthood Abortion Clinics......................................................................................368
6. The disclosures of patients PHI made by the Planned Parenthood abortion
clinics, and received by StemExpress, were neither required nor permitted under
HIPAA, and in particular did not meet the exceptions for cadaveric organ, eye, or
tissue transplantation, or for research ........................................................................369
a) Cadaveric organ, eye, or tissue transplantation ........................................................ 369
b) Research ...............................................................................................................369
c) Violations Preceding Consent ..........................................................................369
7. The consent for fetal tissue donation obtained by StemExpress from the Planned
Parenthood abortion clinics patients did not constitute sufficient authorizations
for the disclosure of PHI ............................................................................................370
8. The disclosures of patients PHI made by the Planned Parenthood abortion clinics
to StemExpress were not the minimum necessary disclosures to facilitate the
procurement of human fetal tissue from aborted infants ...........................................371
9. StemExpress is not a Business Associate of the Planned Parenthood abortion
clinics under HIPAA ..................................................................................................372
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IX. Biomedical Research and Human Fetal Tissue ................................................................373

A. Success of the United States Biomedical Research Enterprise ..................................373
B. Response to the misleading and false arguments made by scientific societies,
medical, societies and universities ................................................................................374
1. Concerns regarding the privacy and safety of researchers involved in human fetal
tissue research ............................................................................................................375
2. The false claim that human fetal tissue was used in the last century to produce
vaccines for polio and other diseases .........................................................................376
a) Early vaccine research did not rely in any way on human fetal tissue ................376
b) The polio vaccine was not produced using human fetal tissue ............................376
c) The Nobel Prize was not awarded for curing polio using fetal tissue ................... 377
d) The vaccine for Measles was not produced using human fetal tissue .................377
e) The vaccine for Mumps was not produced using human fetal tissue ..................378
f) The vaccine for Rubella; an isolated case ................................................................. 378
3. False claims that the production of modern vaccines depends on human fetal
tissue ..........................................................................................................................379
a) Historic use of fetal cell lines in vaccine production by pharmaceutical
companies ...........................................................................................................379
b) Modern vaccine production and research ............................................................380
4. Assertions that fetal tissue is necessary for the study of diseases that affect human
brain development, including Zika and Down syndrome ..........................................380
5. Assertions that human fetal tissue is vital for a wide range of life-saving research. 383
6. Claims that human fetal tissue is required for clinical trials and cures .....................385
a) Fetal tissue is used in only a tiny fraction of clinical trials ..................................386
b) Non-fetal stem cells have consistently shown much greater clinical promise
than fetal stem cells ..............................................................................................386
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c) Conclusion..................................................................................................................... 387
7. Assertions that human fetal tissue is required for production of humanized mice
that provide a model for human diseases with a restricted host range.......................387
8. Assertions that human fetal tissue is required to validate scientific findings
obtained with human embryonic stem cells (hESCs) or human induced
pluripotent stem cells (hiPSCs)..................................................................................388
C. Response to the claim that The Select Panel Has Thwarted Life-Saving
Research ........................................................................................................................388
1. Alzheimers ................................................................................................................389
2. Amyotrophic lateral sclerosis (ALS) ........................................................................390
3. Diabetes Mellitus (DM) ............................................................................................390
4. HIV/AIDS ..................................................................................................................391
5. Infant and Childhood Leukemia ................................................................................392
6. Age-related Macular degeneration (AMD) ...............................................................393
7. Preterm birth ..............................................................................................................393
8. Spinal cord injury.......................................................................................................393
9. Vaccine research ........................................................................................................393
10. Zika research ..............................................................................................................394
11. Objective Data on the contribution of fetal tissue to basic research, clinical
research, and peer-reviewed scientific publications ..................................................394
12. Conclusion .................................................................................................................396
D. Analysis of currently funded long-standing human fetal-tissue research .................396
1. Goals of This Analysis ...............................................................................................396
2. Criterion for Grant Selection ............................................................................................. 396
3. Grant Classification ............................................................................................................ 397
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4. Class 1 Grant Analysis ....................................................................................................... 398

5. Productivity of Human Fetal Tissue Research and Impact on the Field....................399
E. Recommendations for improving access to ethical and appropriate scientific
models ...............................................................................................................................400
X. Recommendations .................................................................................................................406
A. Recommendations for Direct Protection of Women and Infants ..............................406
B. Recommendations for Stewardship of Taxpayer Funds ............................................407
C. Recommendations to Improve Biomedical Research .................................................408

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Executive Summaries
I.

Congress Establishes the Select Investigative Panel

David Daleiden, an investigative journalist, released undercover videos beginning in July

2015, recorded while posing as the head of a company interested in the fetal tissue
procurement business. In numerous meetings with abortion providers and companies
involved in the transfer of fetal tissue, Daleiden recorded doctors, executives, and stafflevel employees discussing various aspects of the fetal tissue procurement industry.

The videos and other materials that Daleiden acquired detailed the relationship between
fetal tissue procurement companies, including Advanced Bioscience Resources, DaVinci
Biologics, and StemExpress, and several abortion clinics.

The expos followed an investigation Daleiden conducted through a not-for-profit group

he founded, the Center for Medical Progress (CMP). CMPs first project, the Human
Capital investigation, took almost three years. Working under the guise of a tissue
procurement business in order to gain access to the top levels of Planned Parenthood,
Daleiden, Susan Merritt, and other activists recorded numerous videos documenting
conversations in which Planned Parenthood executives discussed the procurement of fetal
tissue from aborted fetuses.

The investigation culminated with the release of eleven videos documenting the practices
of local abortion clinics and groups affiliated with the fetal tissue procurement industry.
Daleiden and his colleagues filmed hundreds of hours of meetings and conversations.
According to the Washington Post, they filmed 500 hours of footage at two conferences
alone.

Multiple clips show abortion providers and executives admitting that their fetal tissue
procurement agreements are profitable for clinics and help keep their bottom line healthy.
Multiple clips also show them admitting that they sometimes changed the abortion
procedure in order to obtain a more intact specimen, and some use the illegal partial birth
abortion procedure.

Planned Parenthood Federation of America (PPFA) also revealed that they intentionally
had not set a policy about remuneration for fetal tissue because the headlines would be
a disaster. While the organizations executives told affiliates to think, New York
Times headline if this went badly, at the end of the day, they thought [selling fetal
tissue] is a good idea.

Congress responded to the videos by holding hearings and initiating investigations. The
Energy and Commerce Subcommittee on Oversight and Investigations initiated an
investigation of fetal tissue transfers. The Committee on Oversight and Government
Reform and the Judiciary Committee conducted hearings and also initiated investigations.
xviii

On October 7, 2015, Rep. Virginia Foxx (NC-5) managed the floor debate for H. Res.
461, a proposal for a centralized and comprehensive congressional investigation. During
debate, Rep. Mimi Walters (CA-45) noted, This resolution would create a select panel
to investigate a number of claims related to Planned Parenthoods activities involving
abortion and fetal tissue procurement. Like many Americans, I was horrified by the
recent videos which depicted Planned Parenthood employees callously discussing the
trafficking and sale of aborted babies tissues and organs. Rep. Marsha Blackburn (TN7) summarized:
I want to clearly state this is about getting answers of how we treat
and protect life in this country. The select panel will act to centralize
the investigations that are at the Energy and Commerce Committee,
Judiciary and Oversight Committees, and bring it all under one
umbrella. Over the past several weeks, we have had lots of serious
questions. They are troubling questions that have been asked. I think
that the investigations we have had have raised a lot of those
questions. It is imperative that we centralize these operations and
bring it together under one umbrella.

Congress passed H. Res. 461 by a recorded vote of 242 yeas and 184 nays. Rep.
Blackburn was named Chairman of the Panel.

The Panel did not design its investigation to prove or disprove the credibility of tapes
released by the Center for Medical Progress (CMP); however, the Panel viewed the
videos as a series of serious claims made by a citizen advocacy group.

The Panels investigation identified four business models involving fetal tissue
procurement:
o The Middleman Model. This model comprises a middleman and tissue procurer
who obtains tissue directly from a source such as an abortion clinic or hospital
and then transfers the tissue to a customer, usually a university researcher.
o The University/Clinic Model. This model comprises a particular university that
has formed a close relationship with a nearby abortion clinic and regularly
acquires tissue from that clinic for research purposes.
o The Biotech Company/Clinic Model. This model comprises a close relationship
between a particular biotech company and one or more nearby clinics.
o The Late-Term Clinic Model. This model is of particular concern due to the
intersection of late-term abortions, the potential for live births during the abortion
procedure, and the transfer of tissues or whole cadavers from that clinic to
research entities.
xix

The Panel designed an investigative work plan based on these business models.

II. Applicable Laws, Regulations, and Commissions

Federal and state laws germane to the Panels investigation can be grouped into four
broad categories, with some overlap: (1) laws protecting human research subjects and
patient privacy; (2) laws regulating anatomical gifts for transplantation, therapy, research,
and education; (3) laws protecting late-term and born-alive infants; and (4) laws
pertaining to public funding for fetal tissue research and abortion providers.

A. Laws protecting human research subjects and patient privacy

Laws protecting human research subjects and privacy are rooted in the principles set forth
in the Belmont Report.

Research subjects must be respected as autonomous persons, researchers must adhere to

the Hippocratic ideal, and the benefits of research must outweigh the risks to human
research subjects.

The Panel examined the legal and ethical importance of informed consent under the
Belmont principles. During the Panels hearing on Bioethics and Fetal Tissue. Rep.
Vicky Hartzler (MO-4) addressed an important statement in the Belmont Report
regarding informed consentthat inducements [to consent] that would ordinarily be
acceptable may become undue influences if the [research] subject is especially
vulnerable.

Mrs. Hartzler asked an ethics expert if a form known to be widely used by abortion
clinics to obtain a mothers consent to donate fetal tissue complied with HHSs mandate
against inducement. The form stated that [r]esearch using the blood from pregnant
women and tissue that has been aborted has been used to treat and find a cure for such
diseases as diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS.

The witness agreed that this was an important question, because the idea of the promise
of cures found in the form was a very powerful motivator. The witness also indicated
that the consent form was deficient in other ways: The concern I have is that the
standards that we have typically for fetal tissue donation are just absent here. And so in
addition to the voluntariness, there is just the thoroughness of the consent [that] seems to
be missing in this form.

The testimony provided by witnesses invited by both the majority and minority raised
concerns that the principles embodied in the Belmont Report, and later incorporated into
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federal regulations, are not being followed by abortion providers seeking consent for the
donation of human fetal tissue.

In response to the Belmont Report, HHS and the FDA significantly revised their human
subjects regulations in 1981. The Common Rule applies to research projects that receive
funding from federal agencies, requiring three steps to be fulfilled before the research can
take place: 1) the human subject must give informed consent; 2) an Institutional Review
Board (IRB) must review the proposed research project; and 3) the institution conducting
the research must file an assurance of compliance with the federal agency that is
providing the funding.

The Panels investigation revealed evidence that the IRB process used by some fetal
tissue procurement businesses is often grossly insufficient. For instance, on March 29,
2016, the Panel issued a subpoena to BioMed IRB which required it to produce
documents sufficient to show BioMed IRBs ongoing oversight, within the definition of
federal regulations, of any entity involved with fetal research or transplantation of fetal
tissue for which it issued an IRB approval. BioMed IRBs executive director informed
the Panel on April 4, 2016, that in regards to those records, there are none. This is an
apparent direct violation of federal regulations.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule
(Privacy Rule) protects all individually identifiable health information held or transmitted
by a covered entity or its business associate and calls this information protected health
information (PHI). PHI identifies an individual, or can reasonably be believed to be
useful in identifying an individual, and includes demographic data relating to an
individuals health condition, provision of health care, or payment for the provision of
health care to the individual.

The Panels investigation indicates that StemExpress and Planned Parenthood Mar Monte
(PPMM), Planned Parenthood Shasta Pacific (PPSP), and Family Planning Specialists
Medical Group (FPS) committed systematic violations of the HIPAA Privacy Rule from
about 2010 to 2015. These violations occurred when the abortion clinics disclosed
patients individually identifiable health information to StemExpress to facilitate the
TPBs efforts to procure human fetal tissue for resale.

B. Laws regulating anatomical gifts for transplantation, therapy, research, and education

Laws regulating anatomical gifts are also heavily centered on the need for informed
consent. Additionally, federal and many state laws explicitly prohibit the sale of human
body parts.

The National Organ Transplant Act (NOTA) provides that [i]t shall be unlawful for any
person to knowingly acquire, receive, or otherwise transfer any human organ for valuable
consideration for use in human transplantation if the transfer affects interstate commerce.
. . . Any person who violates [] this section shall be fined not more than $50,000 or
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imprisoned not more than five years, or both. The term human organ is defined to
include fetal organs and subparts of organs.

The Uniform Anatomical Gift Act (UAGA), a model statute first available in 1968 and
most recently amended in 2009, was written to facilitate organ donation for
transplantation, therapy, research, and education by ensuring that state laws are consistent
across the country.

The UAGA, adopted in every state in some form, includes stillborn babies and fetuses in
the definition of decedent for purposes of obtaining consent from a relative before the
deceased infants body is donated for experimentation or transplantation. In the UAGAs
official notes, the drafters explain that the inclusion of stillborn babies and fetuses
ensures that they receive the statutory protections conferred by this [act]; namely that
their bodies or parts cannot be used for transplantation, therapy, research, or education
without the same appropriate consents afforded other prospective donors.

The Panel learned that the University of New Mexico (UNM) and the late-term abortion
clinic Southwestern Womens Options (SWWO) have an extensive history in which
SWWO provided fetal tissue to UNM researchers. SWWOs provision and UNMs
acquisition of and research using aborted infant remains appear to violate New Mexicos
anatomical gift act, the Spradling Act.

Under the NIH Revitalization Act of 1993, it is unlawful for any person to knowingly
acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if
the transfer affects interstate commerce.

Laws regulating the donation of human organs, including human fetal organs, are
relevant for the Panels investigation, given the possibility that both tissue procurement
businesses (TPBs) and abortion providers are profiting from fetal tissue procurement.

During the Panels April 20, 2016 hearing, The Pricing of Fetal Tissue, Panel members
asked witnesses to examine evidence that payments paid by customers to a TPB for fetal
tissue exceeded costs incurred by the business by a factor of 300 to 700 percent. Further,
the evidence did not demonstrate that in many instances the compensated abortion
clinics incurred any actual costs.

C. Laws protecting late-term and born-alive infants

Laws protecting late-term unborn infants and infants born alive during abortion
procedures recognize that the right to an abortion does not equal the right to a dead
child. Federal laws prohibit a specific abortion procedure that occurs seconds before
livebirth, and explicitly provide that infants born alive enjoy all of the constitutional
rights available to other Americans.

xxii

During the Panels investigation, staff reviewed tissue procurement notes, email
exchanges among researchers, TPBs and abortion clinics, invoices, and moreall
indicating that researchers want fetal tissue from late-gestation infants that has not been
tainted by feticidal agents (e.g., digoxin).

The Panel also learned that abortion providers may modify abortion procedures, in
apparent violation of the law, to increase the odds of getting an intact infant cadaver (e.g.,
increase the number of laminaria placed in a patients cervix to achieve greater dilation).
Clearly, these factors increase the likelihood that unborn infants are born alive during late
second-trimester abortions, and raise the question whether these infants civil rights are
recognized by abortion providers.

D. Laws pertaining to public funding for fetal tissue research and abortion providers

Finally, laws pertaining to public funding for fetal tissue research and abortion providers
need reforming. In particular, while federal law contains numerous restrictions on public
funding for abortion, abortion providers receive millions of federal dollars ostensibly for
other purposes.

Government investigations and whistleblower testimonies have revealed that abortion

providers often fail to separate public funding from abortion-related costs.

The Charlotte Lozier Institute and Alliance Defending Freedom have documented that
based on 51 known external audits or other reviews of Planned Parenthood affiliates
financial data and practices, and 61 federal audits of state family planning programs by
HHS-OIGPlanned Parenthood affiliates have overbilled $132.4 million in Medicaid
and other healthcare funding programs. These audit results are troubling, given their
limitations in scope, detail, and timeframe; in fact, of 57 U.S. Planned Parenthood
affiliates, only 19 have been audited.

The Obama administration has denied or threatened to deny federal Medicaid funding to
states that have attempted to withhold Medicaid reimbursement from abortion providers.
Further, the Seventh and Ninth Circuits have interpreted Medicaids free choice of
provider provisionguaranteeing Medicaid recipients freedom to choose their family
planning providersas a legal impediment to prohibiting abortion providers from
receiving federal Medicaid funding.

However, in Planned Parenthood v. Indiana the Seventh Circuit upheld Indianas

prohibition on abortion providers receiving funding through the federal Disease
Intervention Services agency (DIS), for the diagnosis and monitoring of sexually
transmitted diseases. The Seventh Circuit explained that the key difference between the
provision upheld and the provision struck down was that the DIS program did not have a
federal statutory limitation (similar to Medicaids free choice of provider provision) on
how states could determine eligibility.
xxiii

Title X is the only federal grant program dedicated solely to providing family planning
and related preventive care and is viewed as setting the standard for publicly funded
family planning services. Priority is given to low-income families. Title X provides that
none of the funds appropriated shall be used in programs where abortion is a method
of family planning. Public and private entities may obtain grants.

Since 2011, numerous states have enacted laws requiring subrecipients of Title X funds
to provide comprehensive healthcare to patients and/or refrain from performing
abortions. In response, the federal government is actively circumventing the Title X
prioritization laws in at least eight states by directly contracting with private entities such
as Planned Parenthood.

Further, on Sept. 9, 2016, HHS issued a proposed rule stating that [n]o recipient making
sub awards for the provision of services as part of its Title X project may prohibit an
entity from participating for reasons unrelated to its ability to provide services
effectively. In the proposed rule background, HHS states that 13 states have placed
restrictions on or eliminated sub awards with specific types of providers. . . .

Chapter III. Panel Hearings

The Panel held two public hearings to examine critical issues within its jurisdiction. In
the first hearing on Bioethics and Fetal Tissue, the Panel noted that there have been
several government-sponsored discussions on bioethics, but none directly on the transfer
of fetal tissue since the 1980s.

The hearing revealed substantial concern about the consent process for the donation of
human fetal tissue used by abortion clinics and tissue procurement businesses (TPBs).
Evidence revealed that self-interested staff, whose pay depends on the numbers of
specimens donated, were assigned to obtain consent from patients.

Additional evidence showed that tissue technicians and the abortion clinics violated the
patients privacy rights under the Health Insurance Portability and Accountability Act of
1996 (HIPAA). Still other evidence revealed that some TPBs misrepresented that the
consent forms and methods of tissue harvesting comply with federal regulations
regarding Institutional Review Boards (IRBs). This evidence points toward conduct
focused on profit and not on patient welfare.

The Panels next hearing, The Pricing of Fetal Tissue, sought the judgment of seasoned
federal prosecutors to compare the federal statute prohibiting profit from fetal tissue sales
with the first tranche of materials from the investigation.

Two former U.S. attorneys and a senior federal litigator agreed that based on the
materials presented to them, they would open a case against a TPB. The former
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prosecutors also suggested that accounting and bank records would be critical to
understanding whether there was a violation of federal law. Minority witnesses agreed
with this approach and urged the panel to obtain such records.

Chapter IV. The Criminal Referrals

The Select Investigative Panel has made numerous criminal and regulatory referrals and
investigations are underway around the nation.
1) The Panel learned that StemExpress and certain abortion clinics may have violated the HIPAA
privacy rights of vulnerable women for the sole purpose of increasing the harvesting of fetal
tissue to make money. Referred to the U.S. Department of Health and Human Services.
2) The Panel uncovered evidence showing that StemExpress may have violated federal
regulations governing Institutional Review Boards (IRBs). Referred to the U.S. Department of
Health and Human Services.
3) The Panel discovered that the University of New Mexico may have been violating its states
Anatomical Gift Act by receiving tissue from a late-term abortion clinic (Southwestern Womens
Options). Referred to the Attorney General of New Mexico.
4 & 5) The Panel conducted a forensic accounting analysis of StemExpress limited production
and determined that it may have been profiting from the sale of baby body parts. Referral sent to
El Dorado, California District Attorney, and the U.S. Department of Justice.
6) The Panel discovered that an abortion clinic in Arkansas may have violated the law when it
sent tissue to StemExpress. Referred to the Attorney General of Arkansas.
7) The Panel discovered that DV Biologics, another tissue procurement company, may have been
profiting from the sale of fetal tissue, and was not collecting California sales tax from purchasers
of the baby body parts. The Orange County District Attorney has filed a lawsuit and the Panel
sent a supplemental referral.
8) The Panel learned that Advanced Bioscience Resources appeared to have made a profit when
it sold tissue to various universities. Referred to the District Attorney for Riverside County,
California.
9) The Panel discovered that an abortion clinic in Florida, at least in part through its relationship
with StemExpress, may have violated various provisions of federal and state law by profiting
from the sale of fetal tissue. Referred to the Attorney General of Florida.

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10) The Panel learned that Planned Parenthood Gulf Coast may have violated both Texas law
and U.S. law when it sold fetal tissue to the University of Texas. Referred to the Texas Attorney
General.
11 & 12) The Panel has uncovered evidence from former employees and a patient of a late-term
abortionist in Texas alleging numerous violations of federal and state law at one or more of the
practitioners clinics. The allegations include eyewitness accounts of the doctor killing infants
who show signs of life both when partially outside the birth canal, in violation of the PartialBirth Abortion Ban Act, and after they are completely outside the birth canal, in violation of the
Born-Alive Infants Protection Act and Texas murder statutes. Referred to the Texas Attorney
General, and the U.S. Department of Justice.
13) The Panel has discovered information that StemExpress may have destroyed documents that
were the subject of congressional inquiries, document request letters, and subpoenas, in violation
of 18 U.S.C. 1519. Referred to the U.S. Department of Justice.
14) The Panel made a supplemental referral to the Attorney General of New Mexico based on
information produced in document productions by the University of New Mexico (UNM) and
Southwestern Womens Options (SWWO), deposition testimony by Doctor #5, and a complaint
and affidavit with supporting documents submitted by a former patient at SWWO. It details the
alleged failure of SWWO and UNM to provide informed consent to women prior to using tissue
from abortions for research at the university.
15) Over the course of its investigation, the Panel has uncovered documents and received
testimony from confidential informants indicating that several entities, including four Planned
Parenthood clinics and Novogenix, may have violated federal law, specifically Title 42 U.S.C.
289g-2, which forbids the transfer of fetal tissue for valuable consideration. Referred to the U.S.
Department of Justice.

Chapter V. Case Studies of the Fetal Tissue Industry The

Middleman Model
A. StemExpress

StemExpress business model was designed to obtain fresh fetal tissue from a large
number of abortion clinics and provide on-demand fetal tissue to researchers around the
world. StemExpress sought to sell fetal tissue on demand through an online
procurement application.

In 2010, StemExpress revenue was $156,312. During 2011, that figure more than
doubled to $380,000, and a year later, in 2012, StemExpress revenue nearly tripled to
$910,000. By 2013, its revenue was $2.20 million, and in 2014 the revenue had once
again more than doubled to $4.50 million.
xxvi

In an attempt to expand the number of abortion clinics from which it procured fetal tissue
and provide fetal tissue to a larger number of researchers, StemExpress developed and
distributed a brochure aimed at abortion clinics nationwide. Further, they attempted to
enter partnership agreements with the National Abortion Federation and Planned
Parenthood Federation of America. If those agreements had been consummated,
StemExpress would have had access to virtually every abortion clinic in the nation.

The Panel learned that StemExpress embedded its tissue technicians at the Planned
Parenthood facilities. StemExpress embedded tissue technicians had advance knowledge
of the abortions scheduled at PPFA clinics. The Panel determined that clinic personnel
gave StemExpress tissue technicians access to patients personal medical information, in
violation of federal law. The Panel determined that StemExpress tissue technicians
obtained consent to donate fetal tissue from women scheduled to undergo an abortion,
procured the fetal tissue, packaged it, and shipped it directly to StemExpress customers.

When they obtained consent to donate fetal tissue at Planned Parenthood affiliates, the
StemExpress tissue technicians used Planned Parenthoods consent form. A Planned
Parenthood executive testified that the Planned Parenthood consent form was misleading
and could possibly be coercive. Federal regulations bar such coercion.

StemExpress used a consent form similar to Planned Parenthoods form at the

independent abortion clinics. That form purportedly was approved by BioMed IRB, a
commercial IRB that was sanctioned by the federal government for multiple violations of
federal regulations. The Panel issued a subpoena to BioMed IRB; however, they
produced no documents and told the Panel they had no records reflecting supervision of
StemExpress procurement activities.

StemExpress entered contracts to procure fetal tissue from three Planned Parenthood
affiliates and five independent abortion clinics. StemExpress paid those abortion clinics a
total of $152,640 for fetal tissue. The Panel determined that the Planned Parenthood
affiliates at which StemExpress procured fetal tissue had no legally reimbursable costs.

The Panel sought to determine whether the doctors working at the abortion clinics
changed their abortion procedures in order to increase the amount of fetal tissue
StemExpress could obtain and thereby generate more revenue for the clinics. The director
of one independent womens clinic from which StemExpress procured fetal tissue
admitted that the abortion clinic changed its clinical practices to procure more liver. A
Planned Parenthood executive acknowledged making changes to obtain tissue as well.

The Panel uncovered evidence that StemExpress may have violated 18 U.S.C. 1519
through StemExpress potential destruction of documents that were the subject of
congressional inquiries, document request letters, and subpoenas. The Panel made a
criminal referral to the U.S. Attorney General.
xxvii

The Panel uncovered evidence that StemExpress may have violated 42 U.S.C. 289g-2,
and Cal. Health & Safety Code 125320(a) by the receipt of valuable consideration in
the form of a profit on its procurement and sale of fetal tissue. The Panel made a criminal
referral to the U.S. Attorney General and the El Dorado, California District Attorney.

The Panel uncovered evidence that StemExpress may have violated the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) by accessing womens private
health information. StemExpress did not have a medically valid reason to see that
information. The Panel made a referral to the U.S. Department of Health and Human
Services.

The Panel found evidence that StemExpress may have violated federal regulations on
informed consent and Institutional Review Boards. The Panel made a referral to the U.S.
Department of Health and Human Services.

The Panel issued a subpoena to StemExpress that required the production of its banking
and accounting records. StemExpress refused to produce any of those records. Due to
StemExpress refusal to comply with repeated subpoenas, the Panel recommended that
the House of Representatives hold StemExpress in contempt of Congress.

B. DaVinci Biosciences, LLC/DaVinci Biologics, LLC

The Panel sought to determine whether DaVinci Biosciences, LLC (DaVinci), and
DaVinci Biologics, LLC (DVB) may have violated 42 U.S.C. 289g-2 and an equivalent
provision of the California Health and Safety Code.

The Panel determined that DaVinci and DVB appeared to operate a profit-driven
business.

The Orange County, California District Attorney filed a lawsuit that alleged DaVinci and
DVB appeared to operate a profit-driven business and thus violated 42 U.S.C. 289g-2.

DaVinci and DVB charged considerably more for fetal tissue and cell lines derived from
that tissue than the costs it incurs.

The firms business and marketing plans show that officers and directors pushed their
employees to sell more and more tissue, and thus increase DaVinci and DVBs bottom
line.

The companys sole source of fetal tissue was Planned Parenthood of Orange and San
Bernardino Counties (PPOSBC).

DVB senior executives made charitable contributions to PPOSBC before the companys
contract to procure fetal tissue from PPOSBC was signed.
xxviii

The DVB executives made further contributions to PPOSBC before the first procurement,
and those contributions continued.

The Panel uncovered evidence that DaVinci and DVB may have violated provisions of
the California Tax Revenue and Tax Code. The Panel made a referral to the Orange
County (California) District Attorney.

C. Novogenix Laboratories, LLC

The Panel sought to determine whether Novogenix Laboratories, LLC (Novogenix)

complied with all applicable federal and state laws.

The Panel determined that Novogenix may have violated 42 U.S.C. 289g-2, provisions
of the California Health & Safety Code and the California Revenue and Tax Code, and
federal regulations.

Novogenix had a contract to procure fetal tissue from Planned Parenthood Los Angeles
(PPLA). The contract provided that Novogenix would reimburse $45 per donated
specimen.

Invoices produced to the Panel by some of Novogenixs customers show that it received a
total of $170,980.59 from seven research institutions between June 2011 and December
2015. The Panel cannot determine either the total number of Novogenix customers, nor
its revenue.

Novogenix represented that it lost a total of $160,540.03 on its fetal tissue operations, but
conceded that its counsel created the firms expenses and revenue document. The Panel
cannot rely on the expenses and revenue document to determine whether Novogenix
actually lost money on its fetal tissue operations, because it was created by Novogenixs
counsel, and Novogenix produced no primary source accounting records.

The list of expenses included an unknown amount for attorney fees. Such fees are not
included under the list of allowable reimbursements under 42 U.S.C. 289g-2. The list of
expenses also included minimal amounts for delivery to researchers. Invoices produced to
the Panel by Novogenix customers show the firm charged delivery fees of up to $122.43
per shipment, raising further questions about the reliability of the attorney-created cost
document.

PPLA personnel obtained consent from patients to donate tissue from their aborted
fetuses using the standard Planned Parenthood Federation of America (PPFA) consent
form. That form contends that fetal tissue has been used to find a cure for such diseases
as diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS. There is no cure
for those diseases.
xxix

Numerous witnesses, including senior PPFA officials, testified that the consent form is
misleading and unethical due to its contention that fetal tissue has been used to find a
cure for diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS.

Federal regulations provide that entities cannot coerce pregnant women into the donation
of fetal tissue. PPFA officials acknowledged to the Panel that the language in the PPFA
consent form may be coercive. Therefore, Novogenix may have violated federal
regulations.

The California Revenue and Tax Code requires entities that collect sales tax on
transactions made over the Internet within the state of California. The Panel has
determined that Novogenix sold its services to customers in California; it should have
collected tax on some of those transactions.

D. Advanced Bioscience Resources, Inc.

Advanced Bioscience Resources (ABR), a non-profit corporate foundation, was started in

1989 as a resource for biomedical, scientific, and educational purposes. It obtains fetal
tissue from abortion clinics and offers it to researchers for a fee. ABR generally pays
abortion clinics a flat per-tissue fee regardless of the type or amount of tissue procured.
The tissue is obtained by tissue technicians embedded by ABR in abortion clinics. The
technicians harvest, package, and ship the tissue to the researchers. The abortion clinic
staff obtains consent from the patients for fetal tissue donations. ABRs business model is
similar to that of StemExpress.

The Panel conducted an investigation of ABR and uncovered evidence that ABR may
have violated 42 U.S.C. 289g-2 and the California Health and Safety Law. Therefore,
the Panel sent criminal referrals to U.S. Attorney General Loretta Lynch and the District
Attorney of Riverside County, California, urging both to investigate whether ABR
violated federal and state statutes and regulations, and to take appropriate action if the
investigations reveal criminal behavior.

E. Human Fetal Tissue Repository (Albert Einstein College of Medicine)

The Panel sought to determine whether the Human Fetal Tissue Repository (HFTR) fully
complied with applicable federal law and regulations. HFTR only produced a partial list
to the Panel of the entities from which it received and to which it distributed fetal tissue.
The Panel had insufficient evidence to determine whether HFTR complied with the
applicable federal law.

The Panel sought to determine how HFTR disposed of its stored fetal tissue after its
closure. The Panel had insufficient evidence to make that determination; however, there
are indications that Albert Einstein College of Medicine (Einstein) offered the tissue to
the Planned Parenthood Federation of America (PPFA).
xxx

HFTR received fetal tissue from three New York City hospitals and distributed the tissue
to researchers at Einstein and fourteen other educational and research institutions.

The Panel sought to determine HFTRs procurement procedures, including whether it had
contracts with the hospitals from which it procured fetal tissue. Due to the lack of records
provided by Einstein, the Panel had insufficient evidence to determine whether HFTR
had contracts with those medical facilities; how much, if anything, HFTR paid for the
tissue; whether the hospitals or HFTR obtained consent; how the consent was obtained;
and the content of the consent form.

The Panel sought to determine the number of women from which HFTR obtained fetal
tissue, and the number of fetal tissue samples HFTR obtained. Documents produced by
Einstein to the Panel show that a total of 2,701 subjects were enrolled in HFTR studies.
The Panel had insufficient evidence to determine the number of fetal tissue samples
HFTR obtained.

The Panel sought to determine whether HFTR complied with the applicable federal
regulations on research. HFTR required researchers to do the following: submit
summaries of their IRB-approved protocol; provide a copy of their IRB approval letters;
state what tissues they will use for their study and why they must use human tissue
generally and fetal tissue in particular; and agree to use the samples in compliance with
all applicable laws and regulations.

Based solely on HFTRs limited productions, The Panel determined that it appeared
HFTR complied or at least attempted to comply with the applicable HHS regulations. The
Panel has insufficient evidence to make a conclusive determination whether HFTR and
the research institutions to which it supplied fetal tissue fully complied with the
applicable federal regulations.

Chapter VI. Case Studies of the Fetal Tissue IndustryThe

University/Clinic Model

The Panel identified several research institutions across the United States, mostly state
universities and virtually all recipients of federal as well as state funding, that have
formed a close relationship with one or more abortion clinics.

These institutions regularly acquire tissue from those clinics for research purposes and in
some cases disseminate fetal tissue to other research institutions. Typically, the research
institution requests specific human fetal organs or tissue, of a specific gestational age,
from an abortion clinic, and the clinic informs the research institution when they have
abortions scheduled that may produce the desired fetal body parts. Over time, the clinic
thus learns which human fetal organs and tissue are useful to the research institution and
often alerts the research institution to their availability without prior solicitation. Once
xxxi

available, the research entities make arrangements to transfer the fetal organs and tissue
from the clinic.

In some cases, the research institutions also have relationships with tissue procurement
companies. In still other cases, partnerships do not involve the transfer of fetal tissue
between the clinics and universities, but they share medical school faculty and residents
in common, raising additional issues about the role of government-funded institutions in
driving demand for fetal tissue.

The Panel sought to understand these and other factors relevant to its analysis of fetal
tissue transactions under 42 U.S.C. 289g-2 and to determine what role, if any,
government funding plays in the transactions between abortion clinics and universities.

The Panel examined the relationship between the University of New Mexico (UNM) and
Southwestern Womens Options (SWWO), a late-term abortion clinic near the university
that performs abortions through the third trimester. A tissue technician employed by
UNM traveled to SWWO to procure human fetal organs or tissue an average of 39 times
a year since 2010.

The transfer of fetal tissue from SWWO to UNM was one part of an aggressive campaign
under which leadership personnel at UNM medical school: (1) expanded UNMs role
both in providing abortions and in training new abortion providers; (2) expanded UNMs
referral for abortion services to outside clinics, including the clinic from which it
obtained fetal tissue; (3) supplied residents and fellows to perform abortions for SWWO
during the period that UNM was obtaining fetal tissue from that clinic; (4) expanded the
faculty of UNM by providing volunteer faculty status to local abortionists; (5) provided
staff physicians for the Planned Parenthood in Albuquerque from UNM faculty after that
clinic transitioned from one owner to another; and (6) leveraged their status to organize
UNM employees and students for partisan political activities.

The close relationship between UNM and SWWO led to allegations of shoddy clinical
practices, including failure to utilize a consent form for fetal tissue donation and
improperly combining consent for tissue donation with consent for the underlying
abortion procedure. The Panel found the consent practices appeared to violate both
federal and state law governing informed consent. It also found that the transfer of fetal
tissue from SWWO to UNM for research purposes is a systematic violation of New
Mexicos Spradling Act, under which tissue from aborted infants cannot be anatomical
gifts.

While UNM may not have made direct payments to SWWO for the fetal tissue it
received, UNM did provide the clinic a substantial value in the form of personnel offered
to the clinic, in addition to conferring upon at least three staff physicians at SWWO
faculty positions. Those positions gave them numerous benefitsincluding professional
liability insurance coverage for UNM activities, access to university facilities, and
xxxii

discounts. Because they did not have teaching responsibilities, these faculty members
provided UNM no apparent benefit apart from the fetal tissue that came from SWWO,
giving their relationship the components of an exchange of fetal tissue for valuable
consideration.

At a minimum, this arrangement violates the intent and spirit of 42 U.S.C. 289g-2.
Additionally, SWWO made a statement to the Panel that it does not participate in
research, study, or other work involving fetal tissue, which appears to be belied by both
the internal and published documents that constitute evidence that the clinic and its
personnel did in fact participate in fetal tissue research beyond supplying the tissue to
UNM.

The Panels investigation into the nations largest fetal tissue bank, the University of
Washingtons Birth Defects Research Laboratory (UW BDRL), and outside abortion
clinics provides another example of the interdependence of clinics and public research
institutions. UW BDRL received over $600,000 from the NIH for FY 2015. Over the last
five years, over a dozen clinics have provided UW BDRL fetal tissue, and 40 universities
or other public research institutions have been recipients of fetal tissue. UW BDRL
claims that recipients of tissue are charged a flat fee of $200 regardless of the nature of
the tissue researched and that the only payments it makes to clinics are to cover costs.

The university failed to make a complete production, however. The Panels independent
research found that UW BDRL deploys doctors to outside abortion clinics and that
numerous physicians on the staffs of those clinics hold faculty positions at UW BDRL.
The invoices produced by UW BDRL are heavily redacted, rendering it impossible
without more information to conduct a full forensic analysis under 42 U.S.C. 289g-2 of
payments made to and by UW in connection with transfers of fetal tissue.

The Panel conducted an investigation of Planned Parenthood Gulf Coast (PPGC), a

Planned Parenthood Federation of America (PPFA) affiliate that had its own research
department. The Panel uncovered evidence that PPGC may have violated 42 U.S.C.
289g-2 and Texas Penal Code 48.02, which bar the offer to sell or transfer fetal tissue
in its procurement of fetal tissue for the University of Texas Medical Branch (UTMB)
and Baylor College of Medicine (BCM). The Panel also uncovered evidence that PPGC
may have violated Texas Penal Code 37.08, which makes it a crime to lie to a law
enforcement officer during the course of an investigation. The Panel referred those
potential violations of state law to the Texas Attorney General.

The Panel determined that PPGC may have violated PPFAs own guidelines on programs
for the donation of fetal tissue. PPFA required its affiliates that engage in fetal tissue
donation to document their actual costs through an independent accountant, or accept no
reimbursement. A PPGC official testified that PPGC determined its reimbursement from
UTMB and BCM by back of the envelope calculations. PPGC thus had no actual
knowledge of its costs.
xxxiii

The Panel determined that PPGC charged UTMB $150 per executed consent, $50 if the
UTMB technician did not transport the tissue, $2,000 a year in administrative and
training fees, and $1,500 in staff time. Had PPGC obtained 500 patient consents for
UTMB, as specified in an unexecuted contract, UTMB would have paid PPGC $75,000
for consents alone. PPGC sought to enter into a contract with BCM that contained similar
payment terms. The Panel determined that BCMs Institutional Review Board (IRB) had
approved the contract to procurement fetal tissue from PPGC.

The BCM-PPGC contract negotiations terminated after a PPGC official told BCM the
affiliate would not commit to the procurement or provision of fetal tissue, and stated that
Texas academic institutions cannot remain publicly silent about their need for human
fetal tissue, yet expect that research collaboration with Planned Parenthood will remain
intact. Those comments were made after the Center for Medical Progress videos were
made public. A PPGC official testified that the videos were the reason for the statement.

Nearly a year later, PPGCs attorney told Texas law enforcement officials that the reason
the BCM arrangement never came to fruition was that BCMs IRB did not approve it.
The Panel determined that comment was false. PPGC officials knew that BCMs IRB had
approved the research project, despite the representations of PPGCs attorney to Texas
law enforcement officials.

The University of Minnesota (UM) is an example of a university that obtains fetal tissue
from procurement companiesin this case, Advanced Bioscience Resources (ABR) and
StemExpressin addition to an area clinic. UM disclosed that approximately 10
researchers at the University of Minnesota have used such tissue currently or in the
recent past and that UM was the recipient of well over $1 million in NIH grants for
projects that used fetal tissue. UMs produced invoices from ABR show charges ranging
from $275 to $2,675 that reflected ABRs varying fee schedule for different types of fetal
tissue, raising questions of liability under 42 U.S.C. 289g-2 that have been examined in
the above analysis of ABR and StemExpress.

UMs underlying fetal tissue practices potentially violate Minnesotas Anatomical Gift
Act, which does not permit the donation of fetal tissue resulting from induced abortions,
and another law requiring disposal of fetal remains by cremation or burial. Following
disclosure of its practices, UM changed its policy to require such tissue to come from
sources outside Minnesota, raising the question of whether Congress should pass
legislation that would prohibit the crossing of state lines to evade state restrictions on
fetal tissue use.

Between 2010 and 2015, Colorado State University (CSU) received $3.5 million in NIH
grants to support projects using fetal tissue, and it had a contractual relationship with
Planned Parenthood of the Rocky Mountains (PPRM) under which CSU personnel were
permitted to collect tissue from the PPRM clinic. The contract permitted reimbursement
by CSU to PPRM for its reasonable expenses incurred during the tissue process, but
questions surround the actual charges, including a $1,500 charge to the University for
xxxiv

Administrative Start Up and $1,600 for consent and processing for 10 specimens. Amid
the public scrutiny surrounding fetal tissue practices, CSU halted acquisition of fetal
tissue from any vendors implicated in the investigation.

Two university training programs for abortion providers, the Ryan Residency Training
Program in Abortion and Contraception and the Fellowship in Family Planning, began at
the University of California San Francisco (UCSF)s Bixby Center for Global
Reproductive Health. Funded by the Susan Thompson Buffett Foundation, both programs
deploy and pay doctors to provide abortion and contraception services. The Fellowship in
Family Planning spread to around 30 other universities and presently has 246 graduated
fellows. The Ryan Program now claims 80 sites in the U.S. and Canada. UCSF is also
directly involved in fetal tissue research, a component of research projects for which the
university received $17.5 million from the NIH.

Planned Parenthood of the St. Louis Region and Southwest Missouri (PPSLR), reportedly
the only clinic in Missouri that provides abortions, was referenced in one of the
undercover CMP videos as extensively involved in fetal tissue research, a matter that
merits further inquiry. In a separate investigation, the Majority Caucus of the Missouri
State Senate concluded, PPSLR may very well have violated both state statute and
Department of Health regulations in their [fetal] disposal practices.

The Panels investigation found that five PPSLR physicians also hold faculty positions at
the Washington University School of Medicine, which offers the Ryan Fellowship as a
vehicle to deploy medical residents to perform abortions at PPSLR. Further investigation
is warranted into whether monetary payments or other value is exchanged among the
entities shared personnel.

The University of Wisconsin, School of Medicine and Public Health (UW SMPH) has
deployed both faculty members of its Ob/Gyn department and medical residents (by way
of the Ryan Fellowship) to work at a clinic designated by Planned Parenthood of
Wisconsin (PPWI). This relationship appears to have been part of a broader plan that
included the procurement and transfer of fetal tissue to UW SMPH for research. The
school maintains it has not obtained fetal tissue from PPWI since November 2010. The
deployments continue, however. UW SMPH has more recently obtained fetal tissue for
research from the Albert Einstein College of Medicine, UW, and ABR. The average
charge in a UW invoice produced to the Panel, which is under $300, is lower than the
lowest charge by ABR in its invoices, which range from $310 to $2,200. Given the
problematical nature of ABRs practices under 42 U.S.C. 289g-2, further investigation
is warranted.

The University of Michigan (UMich) conducts research using fetal tissue obtained from
tissue procurement businesses and universities. Physicians from UMichs Health System
staff a Planned Parenthood clinic in Ann Arbor, Michigan, and medical students are
eligible to provide abortions there through the Ryan Fellowship. One doctor who is both
medical director for Planned Parenthood and an associate professor in UMichs Ob/Gyn
xxxv

department told a Center for Medical Progress journalist that the University of Michigan
IRB . . . tend to be pretty easy about stuff and actually not require informed consent. She
also claimed research projects involving fetal tissue involve grants to the agency to
cover my time, raising the question of whether the grants she refers to cover more than
the permissible reimbursements for costs under 42 U.S.C. 289g-2.

Chapter VII. Case Studies of Late-Term Abortion Clinics

The business practices and procedures of late-term clinics implicate numerous legal and
ethical concerns. When human infants are born alive in late-term abortion clinics or
hospitals, abortion providers are obligated to ensure that these infants are afforded all of
the protections guaranteed by federal and state law. A careful investigation of late-term
abortion providers is necessary to ensure that entities are complying with the federal
Born-Alive Infants Protection Act, Partial-Birth Abortion Ban Act, 42 U.S.C. 289g, et
seq., federal regulations pertaining to human fetal tissue research, and state laws,
including anatomical gift laws.

The significance of this inquiry includes the issue of the taxpayers indirect support of
late-term abortion. In fact, most of the doctors west of the Mississippi who openly
perform third-trimester abortions have faculty positions at either the University of New
Mexico or the University of Colorado. The broad public disapproval of such practices
raises the question of why institutions that receive public funds should carry the tacit
imprimatur imparted by institutional affiliation.

The Panel investigated several abortion providers and clinics across the country:
[Abortion Doctor #1], [Abortion Doctor #2], [Abortion Doctor #3], the University of
New Mexico, and Southwestern Womens Options. Due to the gravity of the allegations
against [Abortion Doctor #3], the Panel made a criminal referral forthwith to both the
United States Attorney General and the Texas Attorney General on December 7, 2016.

Chapter VIII. Case Studies of the Fetal Tissue Industry Planned

Parenthood

Planned Parenthood executives who spoke with the Panel noted that 2016 is the 100th
anniversary of the founding of Planned Parenthood. A closer look at the history of the
organization, however, leaves little to celebrate. The organization was founded by
eugenicists who believed in limiting the rights of people to form families and have
children if they had mental or physical disabilities or were of the wrong race.

Harvard studies about Planned Parenthoods business model have pointed out financial
struggles the organization has faced in recent years, including smaller margins and lower
revenues. Substantial evidence exists that Planned Parenthood clinicsat least 51
xxxvi

timeshave overbilled Medicaid and improperly billed items to cover the costs of
abortion services, in violation of the Hyde Amendment.

During some of Planned Parenthoods difficult financial years, tissue procurement

companies like StemExpress saw an opportunity to market their services to Planned
Parenthood affiliate clinics and even the entire Federation. This move was welcomed by
top Planned Parenthood executives, some of whom were remarkably candid about the
revenue possibilities for clinics.

However, the relationships that have formed between tissue procurement companies,
abortion clinics, and universities are fraught with questionable practices, including the
possible use of illegal, late-term abortion practices to procure fetal tissues and organs,
violations of federal laws and regulations on patient consent, and systematic violations of
patients HIPAA rights.

PPFA doctors have failed to comply with their own requirement obligating abortionists to
certify in writing that they have not changed the method of the abortion to facilitate fetal
tissue donation. The PPFA executive in charge of this requirement admitted to Panel staff
that she has never signed a document certifying this. She additionally admitted that she
regularly changed the method of abortion to facilitate intact fetal specimens.

The Panel found no compliance with an additional PPFA requirement in a memorandum

sent to affiliates by PPFAs legal department. That requirement obligated affiliates to rely
on an auditor before entering into a fetal tissue donation program to ensure that fees
covering allowable costs did not exceed valuable consideration. In fact, one executive
told Panel staff she only uses back of the envelope methods to determine costs
associated with the donations.

Not only did the Panel find a shocking lack of compliance with both internal and federal
regulations, but executives admitted to undercover journalists that the PPFA exercises
very little control of their affiliated clinics. One even said that if clinics wanted to profit
from the transfer of fetal tissue, We cant stop them. We only have carrots and sticks.

Accounting documents from a tissue procurement company, StemExpress, and its bank
reveal substantial payments to Planned Parenthood clinics. Some expenses associated
with fetal tissue donationlike storage and preservationare allowed under federal
regulations, but the Panels analysis of these accounting records found that both
StemExpress and Planned Parenthood claimed the same expenses.

One of the expenses Planned Parenthood frequently claimed was staff time related to
fetal tissue donation. However, the Panels analysis of hundreds of Planned Parenthood
job descriptions revealed that none mention the acquisition, handling or transfer of fetal
tissue.
xxxvii

Planned Parenthood claims it made no profit. The Panel, therefore, asked for accounting
documents to prove this. Instead of turning over the records that could have proved them
innocent, PPFA refused. Its lawyers wrote that [t]he affiliates have each performed a
good-faith accounting of their costs associated with facilitating fetal tissue donation, and
have demonstrated conclusively that those costs exceeded the payments they received.

We didnt profit because we say we didnt profit is not compliance with congressional
requests for documents. Because Planned Parenthood refused to provide actual
documents supporting their claim, the Panel resorted to analyzing accounting documents
from middlemen companies who contracted with Planned Parenthood affiliates.

Chapter IX: Biomedical Research and Human Fetal Tissue

A. The United States Biomedical Research Enterprise is a Success: The Select Panel
recognizes and supports the success of the United States biomedical research enterprise.

The 2014 gross expenditure on Research and Development (R&D) in the United States
exceeded $485 billion, or nearly 27% of the global R&D budget.

The 2012 biomedical research expenditures in the United States exceeded $119 billion,
with the next largest national investment being made by Japan, at just over $37 billion

Between 2000-2013, the Unites States published approximately 40% of all papers in the
area of stem cell research, with the next closest contributor (the United Kingdom)
producing less than 10% of all published research in this rapidly advancing field.

B. Scientific societies and universities have made misleading claims about fetal tissue
research: The Select Panel has received letters from 21 institutions that claim to provide
evidence for the value of human fetal tissue research. The assertions of these letters fall into
8 general classes and have been uncritically repeated in the Minority report. In reality, not a
single responding institution provided substantive evidence for the value of fetal tissue
research.

Claim: The activities of the House Select Panel have identified scientists using fetal
tissue, thereby putting them at risk:
False. The names, institutions and collaborators of individuals conducting human
fetal research are made publicly available by the NIH.

Claim: Fetal tissue was used to produce vaccines for polio, measles, mumps and
rubella.
False. These vaccines were all first produced using animal cells, not fetal tissue.
xxxviii

Claim: Fetal tissue is used for modern vaccine manufacture.

False. Not a single vaccine licensed in the United States is manufactured using
fetal tissue.

Claim: We need fetal tissue to cure Zika and other brain diseases.
False. Fetal tissue is not widely used for Zika research and vaccines for similar
viruses have not been based on human fetal tissue research.

Claim: Fetal tissue is important for a wide range of research.

False. Human fetal tissue is used in a tiny fraction of all NIH-funded research:
0.2% of the over 76 thousand NIH-funded projects.

Claim: Fetal tissue is important for clinical trials.

False. In over 100 years of unrestricted clinical research, human fetal tissue has
failed to provide a single medical treatment: Human fetal tissue is used for only
0.01% of the over 230 thousand FDA-approved clinical trialsand thus far, no
trials using human fetal tissue have reported positive results for patients.

Claim: Fetal tissue is required for scientific models such as the humanized mouse.
False. Alternatives exist and are widely used.

Claim: Human fetal tissue is necessary to validate adult and induced-pluripotent

stem (iPS) cells.
False. Almost no papers using adult and iPS cells also use fetal tissue.

C. Response to the claim that The Select Panel Has Thwarted Life-Saving Research: The
Minority report asserts that human fetal tissue is important for research on many diseases. In
reality, human fetal tissue research makes a vanishingly small contribution to clinical and
research efforts, if it contributes at all (Table 1, below).
D. Analysis of successful, long-standing human fetal-tissue research: Over the last five
years (2010-14), the NIH has awarded 329 grants using human fetal tissue. This represents
0.2% of all grants. The Panel selected 34 successful fetal tissue grants that have been
funded for over ten years and analyzed them in detail to objectively answer three important
questions:
1. How many successful grants actually require human fetal tissue to perform the proposed
experiments (i.e., there are no alternatives proposed by the investigator or used in the
literature)? Answer - Eight grants of 34 (24%) actually require fetal tissue.
xxxix

2. How productive are projects involving human fetal tissue compared to non-fetal
research? Answer - Non-fetal projects produce 2.3x as many papers as fetal projects.
3. What is the importance/impact of papers using human fetal tissue compared to non-fetal
papers? Answer - Non-fetal papers receive 2.1x more citations than fetal tissue
papers.
Conclusion: Human fetal tissue constitutes only a tiny fraction of the overall research effort.
Moreover, research involving human fetal tissue is less productive and has lower
importance/impact when compared to non-fetal research from the same laboratories.
E. Recommendations for improving access to ethical and appropriate scientific models

Recommendation 1: Congress will appropriate funding to the NIH for a trial of

expanding the organ-donation network to included preterm and stillborn infant donors,
excluding tissue from elective termination of pregnancy.

Recommendation 2: The NIH will undertake a study of research demand for adult
human tissue and possible methods for facilitating the acquisition of this tissue for
research.

Recommendation 3: The NIH will establish guidelines for the use of human fetal tissue
(modeled on the guidelines for animal research) and will mandate that these guidelines be
applied to all grants proposing the use of human fetal tissue.

Recommendation 4: The NIH will adopt a three-tiered classification system for

proposals involving human fetal tissue as indicated below:
Class 1: Fetal tissue is required for the proposed study. There are no reasonable
alternatives.
Class 2: Fetal tissue is not essential for the study. There are some scientific advantages
to the use of fetal tissue, but alternatives exist.
Class 3: Fetal tissue is not essential for the study. There are no scientific advantages to
the use of fetal tissue, and alternatives exist.

Recommendation 5: The NIH will report to Congress on the use of parent-donated

tissue from natural demise of preterm children, anticipated by Recommendation 1 above,
and Congress shall appropriate funds for an expansion of this program and disallow
grants funded by federal dollars to utilize human fetal tissue obtained from induced
abortion.

xl

Table 1: Contribution of human fetal tissue to disease research.

Diseases Identified in the
Minority Report
Alzheimers
Amyotrophic lateral sclerosis
Diabetes Mellitus
HIV/AIDS
Infant and Childhood Leukemia
Age-related Macular degeneration
Preterm birth*
Spinal cord injury
Vaccine research
Zika/Brain Disorders**
Diseases Arising in the Fetus
and/or Affecting Children

Grants Awarded
2015
Fetal Total
%
0
1362 0.0%
0
152 0.0%
6
2382 0.3%
74
4935 1.5%
0
339 0.0%
5
187 2.7%
4
355 1.1%
0
249 0.0%
28
2509 1.1%
158 52338 0.3%
Grants Awarded
2015
Fetal Total
%

Clinical trials
Fetal

Total

Peer Reviewed Papers

%

0
1956
0.0%
3
360
0.8%
1 14807 0.01%
0
7950
0.0%
0
750
0.0%
10
1371
0.7%
0
3375
0.0%
8
907
0.9%
0
7024
0.0%
0
18
0.0%
Current clinical trials
Fetal

Total

"Fetus"

Total

109
75704 0.1%
33
14859 0.1%
1486 353110 0.4%
372
87756 0.4%
21
1996 1.1%
15
18826 0.1%
503
9006 5.6%
49
41461 0.1%
509 280174 0.2%
6
1926 0.3%
Peer Reviewed Papers
"Fetus"

Total

Attention Deficit Disorder

0
121 0.0%
0
1277
0.0%
23
23079 0.1%
Autism
2
506 0.4%
0
741
0.0%
43
17711 0.2%
Batten Disease
0
15 0.0%
0
23
0.0%
7
1761 0.4%
Epilepsy
2
397 0.5%
0
1404
0.0%
289 141397 0.2%
Hydrocephalus
0
15 0.0%
0
135
0.0%
275
21192 1.3%
Intellectual disabilities
10
1025 1.0%
0
541
0.0%
1255
86516 1.5%
Pediatric AIDS
0
467 0.0%
0
350
0.0%
8
1586 0.5%
Pediatric cancer
0
760 0.0%
0
1642
0.0%
302
56854 0.5%
Spinal muscular atrophy
0
34 0.0%
0
157
0.0%
15
1050 1.4%
Sudden Infant Death Syndrome
1
31 3.2%
0
89
0.0%
78
7094 1.1%
Grant data is from the NIH project reporter database. Clinical data is from the clinical trials database. Publication data
is from the PubMed database (queried for disease name, fetus and humans as MeSH terms.)
* The NIH does not have a spending category for preterm birth; grant data is for the broader category "Conditions
affecting the embryonic and fetal periods," many of which result in preterm birth or fetal demise.
**The NIH does not have a spending category for Zika; grant data is for the broader category Brain Disorders

Chapter X. Recommendations

The Panel recommends that Congress take numerous actions to provide direct protections
for women and infants, including:
o Ensuring that all donations of fetal tissue are made with informed consent;
o Clarifying the law to ensure that abortion providers do not harm women in order
to procure fetal tissue;

xli

o Directing the Department of Health and Human Services to conduct greater

oversight over misleading consent forms, IRBs, HIPAA violations, and abortion
provider competence to care for infants born alive during abortion procedures;
o Ensuring that the Department of Justice allocates resources to prosecute persons
or entities that profit from the sale of fetal tissue;
o Enacting a law to protect unborn infants after 20 weeks gestation;
o Directing the Department of Health and Human Services to establish protocols for
abortion providers to provide emergency care to infants born alive during
abortions;
o Establishing criminal penalties to enforce the Born-Alive Infants Protection Act,
and;
o Establishing an office in the Criminal Division of the Department of Justice to
ensure the enforcement of the Partial-Birth Abortion Ban Act, the Born-Alive
Infants Protection Act, and other measures recommended in this report.

The Panel also recommends that Congress take actions to ensure good stewardship of
taxpayer funds, including:
o Defunding Planned Parenthood and ensuring that grants no longer available to
Planned Parenthood are awarded to healthcare providers that provide
comprehensive preventive healthcare for their patients and that do not perform
abortions (that are not covered by Medicaid under the Hyde Amendment);
o Providing greater flexibility to states to enact laws prohibiting abortion providers
form receiving Medicaid reimbursement and giving states discretion to choose
subrecipients of Title X funding consistent with state policy, and;
o Prohibiting federal funding of research involving tissue derived from induced
abortions in conjunction with the establishment of a program that would fund
sources of ethically obtained fetal tissue (i.e., fetal tissue from spontaneous
abortions (miscarriages) or stillbirths) for research.

The Panel recommends that Congress take actions to improve biomedical research,
including:
o Appropriating funding to the NIH for a trial of expanding the organ-donation
network to include preterm and stillborn infant donors, excluding tissue from
elective termination of pregnancy.
xlii

o Directing NIH to undertake a study of research demand for adult human tissue
and possible methods for facilitating the acquisition of this tissue for research.
o Directing NIH to establish guidelines for the use of human fetal tissue (modeled
on the guidelines for animal research) and mandating that these guidelines be
applied to all grants proposing the use of human fetal tissue.
o Directing NIH to adopt a three-tiered classification system for proposals involving
human fetal tissue as indicated below:
Class 1: Fetal tissue is required for the proposed study. There are no reasonable
alternatives.
Class 2: Fetal tissue is not essential for the study. There are some scientific
advantages to the use of fetal tissue, but alternatives exist.
Class 3: Fetal tissue is not essential for the study. There are no scientific
advantages to the use of fetal tissue, and alternatives exist.
o Directing NIH to report to Congress on the use of parent-donated tissue from
natural demise of preterm children, anticipated by Recommendation 1 above, and
Congress shall appropriate funds for an expansion of this program and disallow
grants funded by federal dollars to utilize human fetal tissue obtained from
induced abortion.

Chapter XI: Compliance with Congressional Subpoenas

Virtually every entity and individual from whom the Panel sought documents did not
fully comply, regardless of whether the documents were required to be produced pursuant
to a subpoena, or were requested via a letter.

The chart below graphically demonstrates the level of non-compliance by entities and
individuals with the Panels document request letters and subpoenas.

xliii

Preface
The Select Investigative Panel prepared the following Final Report for the U.S. House of
Representatives and the general public. H. Res. 461 established the Panel on October 7, 2015.
The Resolution charged the Panel to investigate and report on the following:
(1) medical procedures and business practices by entities involved in fetal tissue
procurement;
(2) any other relevant matters with respect to fetal tissue procurement;
(3) Federal funding and support for abortion providers;
(4) the practices of providers of second and third trimester abortions, including
partial birth abortion and procedures that may lead to a child born alive as a result
of an attempted abortion;
(5) medical procedures for the care of a child born alive as a result of an
attempted abortion; and
(6) any changes in law or regulation necessary as a result of any findings made
under this subsection.
The Panels duties included completing a final, formal report to Congress no later than
December 31, 2016.
Chairman Blackburn set the priorities of the Panel, directing that the interests of
vulnerable women and children always inform the investigation and that the investigation
encompass the nations entire fetal tissue industry. The Chairmans direction was clear from the
beginning: We must investigate alleged wrongdoing and then propose solutions to the problems
we uncover. Recognizing that the transfer of fetal tissue for profit is a federal criminal offense,
the Chairman focused the investigation on exacting detail, including bank and accounting
records, all with a perspective that the motive for illicit profit could contaminate collateral
activities in four important ways.
First, the sale of fetal tissue for profit could have a corrupting effect on the treatment of
women facing an abortion decision. The Panels work has revealed that this corruption extends
to the method of obtaining consent from the patient, which is both deceptive and unlawful. Also,
those entrusted with patient medical information may violate Health Insurance Portability and
Accountability Act (HIPAA) privacy rights in order to enable businesses to match their customer
orders for human fetal tissue with particular patients.
Second, the Panel was concerned with a history of babies being born alive and the sale of
fetal tissue at some late-term abortion clinics. The Panels investigation has revealed that whole
baby cadavers of a viable age are transferred from some abortion clinics to researchers. The
induction abortion procedure has increased the likelihood that infants will be born alive during
abortions, even while the gestational age of viability has lowered due to medical advancements.
xliv

This intersection, coupled with a profit motive, became part of the Panels focus throughout its
tenure.
Third, the Panel found evidence that some abortion providers altered abortion procedures
in a manner that substitutes patient welfare with a financial benefit for both the abortion clinic
and the procurement business. Since this conduct violates federal law, a thorough investigation
of the practice was critical to understanding the effectiveness of the current statute.
Fourth, the Panel discovered that profit motives taint the integrity of the nations
celebrated history of voluntary organ donation. In recent decades, much work has been done to
create the highest ethical and moral standards, both in law and practice, while making progress
toward healing and curing disease. Selling human fetal tissue for a profit endangers this system
and threatens the future of finding cures. Thus, the Panel made recommendations that improve
the tissue and organ donor system in an ethical way.
The Chairman weighed these four areas of inquiry and held the Panels first hearing on
Bioethics and Fetal Tissue. There have been several government-sponsored discussions on
bioethics, but none directly on the transfer of fetal tissue since the 1980s. The hearing revealed
substantial concern about the consent process for the donation of human fetal tissue used by
abortion clinics and procurement businesses. Evidence revealed that self-interested staff, whose
pay depends on the numbers of specimens donated, were assigned to obtain consent from
patients. Additional evidence showed that tissue technicians and the abortion clinics violated the
patients HIPAA rights. Still other evidence revealed that some middleman companies
misrepresented that the consent forms and methods of tissue harvesting comply with federal
regulations regarding Institutional Review Boards (IRBs). This evidence points toward conduct
focused on profit and not on patient welfare.
The Panels next hearing, The Pricing of Fetal Tissue, sought the judgment of seasoned
federal prosecutors to compare the federal statute prohibiting profit from fetal tissue sales with
the first tranche of materials from the investigation. Two former U.S. attorneys and a senior
federal litigator agreed that, based on the materials presented to them, they would open a case
against a middleman company. The former prosecutors also suggested that accounting and bank
records would be critical to understanding whether there was a violation of federal law. Minority
witnesses agreed with this approach and urged the Panel to obtain such records.
Although the Panel has made significant progress using heavily redacted subpoenaed
documents, the Minority has publicly advocated that the Panel be disbanded and has privately
attempted to obstruct the Panels fact-finding mission. At every turn, the minority has urged that
the Panels requests for information be ignored and even urged noncompliance with
congressional subpoenas. At the behest of the minority, many individuals who have received
congressional subpoenas have heavily redacted critical information, and some have refused to
comply at all. Still others have communicated in writing that they have relied upon Minority
memoranda to support their noncompliance.

xlv

A. Understanding the Final Report with Redacted Names

From the beginning of the Panels investigation, the Chairman directed that the work
focus on the transactions described in H. Res. 461, in particular the transfer of fetal tissue, the
methods of abortion, and the stewardship of federal taxpayer dollars. The Legislative Branch
passes and evaluates laws that govern all Americans and thus, in its Final Report, the Panel has
redacted the names of individuals who engaged in those transactions and substituted descriptive
nouns in their place. This allows the reader to understand the role played by an individual
without disclosing the actual name of the individual.
During the Panels investigation, several persons sought to make themselves publicly
known by making personal comments in the press, including a university researcher, a late-term
abortion doctor, and the CEO of a tissue procurement company. These names are also redacted
from the report and replaced by descriptive nouns. The names of other individuals who perform
more functionary roles, such as tissue procurement technicians or medical assistants, are also
redacted and substituted with descriptive nouns. The Panel received information from
confidential whistleblowers, such as former abortion clinic managers or former employees of
fetal tissue procurement companies. These names are also redacted. The names of university
researchers and medical students whose names appeared on the documents that were part of the
transactions examined by the Panel are also redacted. Individuals abortion doctors names are
redacted. The Panel has also redacted addresses and telephone numbers where they identify
particular individuals.
The Panel conducted depositions and transcribed interviews of several individuals. Those
individuals names and titles are redacted, and the transcript of their testimony before the Panel
is used to explain their role.
Finally, the Panel has not redacted that names of staff of the U.S. House of
Representatives, the names of lawyers who represented particular individuals or entities, the
names of persons who testified before the Panel in open congressional hearings, and the nontransactional names on academic papers that the Panel relied upon to understand the role of
human fetal tissue in research.
The redaction key is outlined below. The Reports exhibits, which number 3,647 pages,
are also redacted. They can be found at: https://energycommerce.house.gov/newscenter/letters/select-investigative-panel-final-report. Additionally, the redaction key is repeated
in each individual Chapter. The Minority proposed and the Majority accepted a set of redaction
placeholders for the witnesses who were deposed by the Panel and persons who volunteered to
be interviewed by the Panel with a written transcript of their interview. Each attorney for the
person deposed or interviewed was invited to suggest edits for the transcripts. The consensus
placeholders are listed first below followed by the Reports additional redaction placeholders.

xlvi

Redaction placeholders for depositions and interviews:

May 6, 2016 deponent: [Clinic A Dr. #1] Testified that she was an OBGYN abortion
provider, a faculty member of University of New Mexico, and an employee of Southwestern
Womens Options clinic.
May 11, 2016 deponent: [Dr. Administrator] Testified the she was an OBGYN abortion
provider, a faculty Member at the University of New Mexico.
July 21, 2016 interview witnesses:
[Clinic B Staff #1] Testified that she was a medical worker at an abortion clinic in
Maryland.
[Clinic B Staff #2] Testified that she was a medical worker at an abortion clinic in
Maryland.
[Clinic B Staff# 3] Testified that she was a medical worker at an abortion clinic in
Maryland.
[Clinic B Staff #4] Testified that she was a medical worker at an abortion clinic in
Maryland.
October 6, 2016 interview witness: [PP Witness #1] Testified that she is an OBGYN
abortion provider in Los Angeles, California, an executive with Planned Parenthood
Federation of America (PPFA) who is in charge of the PPFA Manual of Medical
Standard and Guidelines.
October 19, 2016 interview witness: [PP Witness #2] Testified that she is a manager of
research projects at Planned Parenthood Gulf Coast.
November 1, 2016 interview witness: [PP Witness #3] Testified that she is a university
professor, an OBGYN abortion provider, and serves on the PPFA National Medical
Committee.
November 17, 2016 interview witness: [PP Witness #4] Testified that she works for the
Consortium of Abortion Provider Services at PPFA, which provides technical assistance
to PPFA affiliate clinics.
Additionally, each individual Chapter contains a redaction key with additional names:
Chapter I Redaction Key:

No redactions

Chapter II Redaction Key:

[PP Witness #1] is an abortion provider in Los Angeles, California, an
executive with Planned Parenthood Federation of America (PPFA)
xlvii

who is in charge of the PPFA Manual of Medical Standard and

Guidelines.
[PP Doctor #1] is an abortion provider in Los Angeles, California, who
also works for the Medical Directors Council
Chapter III Redaction Key:

No Redactions

Chapter IV Redaction Key:

Names Redacted from Referral Letters

Chapter V Redaction Key:

StemExpress, LLC:
[PP Witness #1] is an abortion provider in Los Angeles, California, an
executive with Planned Parenthood Federation of America (PPFA)
who is in charge of the PPFA Manual of Medical Standards and
Guidelines.
[PP Doctor #1] is an abortion provider in Los Angeles, California,
who also works for the Medical Directors Council.
[the Founder and CEO] is the founder and CEO of StemExpress, LLC
(StemExpress).
[ABRs Procurement Manager] is the procurement manager at
Advanced Bioscience Resources, Inc.
[FDA Consumer Safety Officer # 1] is a consumer safety officer at the
U.S. Food and Drug Administration.
[FDA Consumer Safety Officer # 2] is a consumer safety officer at the
U.S. Food and Drug Administration.
Novogenix Laboratories, LLC:
[PP Witness #1] Testified that she is an OBGYN abortion provider in
Los Angeles, California, an executive with Planned Parenthood
Federation of America (PPFA) who is in charge of the PPFA Manual
of Medical Standard and Guidelines.
[PP Doctor #1] is an abortion provider in Los Angeles, California,
who also works for the Medical Directors Council
[Founder and Executive Director] is the founder and executive
director of Novogenix Laboratories, LLC (Novogenix).
xlviii

[Supervisor Consumer Safety Officer] is a supervisor consumer safety

officer at the U.S. Food and Drug Administration.
[Consumer Safety Officer] is a consumer safety officer at the U.S.
Food and Drug Administration.
DaVinci Biosciences, LLC / DaVinci Biologics, LLC:
[DVB Executives] are the owners and managers of DaVinci
Biosciences, LLC (DaVinci) and DaVinci Biologics, LLC (DVB).
[DVB Executive # 1] is the president of DaVinci and DVB.
[DVB Executives # 2 and 3] are founding members and officers of
DaVinci and DVB.
Human Fetal Tissue Repository:
[Einstein Executive #1] is an Einstein Executive Dean
[Einstein Executive #2] is an Einstein Vice-President, Government and
Community Relations
[Einstein Executive #3] is an Einstein Vice-President, External Affairs
Chapter VI Redaction Key:
[Clinic A Dr. #1] is an employee of Southwestern Womens Options and a
faculty member of the University of New Mexico.
[Dr. Administrator] is a faculty member of the University of New Mexico.
[NM Doctor #2] is a faculty member of the University of New Mexico.
[NM Doctor #3] is a director of Southwestern Womens Options and a
faculty member of the University of New Mexico.
[NM Doctor #4] is a faculty member of the University of New Mexico.
[NM Doctor #5] is an employee of Southwestern Womens Options and a
faculty member of the University of New Mexico.
[NM Doctor #6] is an employee of Southwestern Womens Options.
xlix

[Dr. Administrator #2] is a faculty member of the University of New

Mexico.
[NM Research Doctor] is a faculty member of the University of New
Mexico.
[NM Patient] was a patient at Southwestern Womens Options.
[WA Clinic Director] is Executive Director and co-founder of the Cedar
River Clinics.
[WA Doctor #1] is a faculty member at the University of Washington and
also works at the Cedar River Clinics.
[WA Doctor #2] is a physician who works at the Cedar River Clinics.
[WA Doctor #3] is a faculty member at the University of Washington and
also works at the Cedar River Clinics.
[WA Doctor #4] is a faculty member at the University of Washington and
also works at the Cedar River Clinics.
[WA Doctor #5] previously worked at the Cedar River Clinics while a
faculty member at the University of Washington.
[WA Doctor #6] is a former University of Washington resident who
worked at the Cedar River Clinics and currently works at the Swedish
Medical Center.
[WA Doctor #7] is a former University of Washington resident who
worked at the Cedar River Clinics and currently works at Northwest
Womens Healthcare.
[WA Doctor #8] is a faculty member at both the University of Washington
and Northwestern University and owner and operator of All Womens
Health-North.
[WA Doctor #9] is a physician who formerly worked at the Cedar River
Clinics and now works at All Womens Health-North.
[WA Patient] was a patient at the Cedar River Clinics who filed a medical
malpractice suit against [WA Doctor #2] for injuries alleged following an
abortion performed at 25+ weeks.

[WA Doctor #10] is a former resident and current faculty member at the
University of Washington who served as medical director of the Planned
Parenthood of Greater Washington and North Idaho.
[WA Doctor #11] is a faculty member at the University of Washington
and also works at the Planned Parenthood of Greater Washington and
North Idaho.
[WA Research Doctor #1] is a faculty member at the University of
Washington and the author of the universitys Birth Defects Research
Laboratorys NIH grant proposals.
[WA Research Doctor #2] is a research scientist at the University of
Washington who has participated in fetal tissue research studies.
[WA Research Doctor #3] is a former resident at the University of
Washington who has participated in fetal tissue research studies.
[WA Research Staff] is a technical operations manager at the University
of Washington School of Medicines WWAMI Institution for Simulation
in Healthcare. He has participated in fetal tissue research studies.
[WA Administrator] is an administrator in the University of Washingtons
government relations office.
[PP Witness #1] is an abortion provider in Los Angeles, California, an
executive with Planned Parenthood Federation of America (PPFA) who is
in charge of the PPFA Manual of Medical Standard and Guidelines.
[PP Witness #2] is a manager of research projects at Planned Parenthood
Gulf Coast (PPGC).
[PPFA Lawyer] is a legal official at PPFA.
[PPFA Medical Officer #1] is a PPFA official who was responsible for
medical issues.
[PPFA Medical Officer #2] is a PPFA official who was responsible for
medical issues.
[PPGC Abortion Doctor] is a doctor who performed abortions at PPGC.
[PPGC Staff] is a PPGC staff worker who assisted in the abortion clinic.

li

[UTMB Researcher # 1] is a researcher at the University of Texas Medical

Branch who worked with PPGC on fetal tissue procurement.
[PPGC Abortion Services Official] is a manager of abortion services at
PPGC.
[PPGC Executive] is the director of abortion services and medical director
at PPGC.
[UTMB Researcher # 2] is a second researcher at the University of Texas
Medical Branch who worked with PPGC on fetal tissue procurement.
[UTMB Staff] is a UTMB staff worker who administers contracts for
researchers.
[BCM Researcher] is a researcher at the Baylor College of Medicine who
worked with PPGC on fetal tissue procurement.
[BCM Staff] is a staff employee at the Baylor College of Medicine who
worked with PPGC on fetal tissue procurement.
[BCM Contract Manager] is an employee of the Baylor College of
Medicine who manages contracts.
[MO Doctor #1] is a faculty member of the Ob/Gyn department of the
Washington University School of Medicine and also works at Planned
Parenthood of the St. Louis Region and Southwest Missouri.
[MO Doctor #2] is Planned Parenthood of the St. Louis Region and
Southwest Missouris pathologist and the owner of Pathology Services,
Inc.
[MO Doctor #3] is a faculty member of the Ob/Gyn department of the
Washington University School of Medicine and also works at Planned
Parenthood of the St. Louis Region and Southwest Missouri.
[MO Doctor #4] is a faculty member of the Ob/Gyn department of the
Washington University School of Medicine and also works at Planned
Parenthood of the St. Louis Region and Southwest Missouri.
[MO Doctor #5] is a faculty member of the Ob/Gyn department of the
Washington University School of Medicine and also works at Planned
Parenthood of the St. Louis Region and Southwest Missouri.
[MO Doctor #6] is or was a clinical fellow in the Ob/Gyn department of
lii

the Washington University School of Medicine and also works at Planned

Parenthood of the St. Louis Region and Southwest Missouri.
[WI Doctor #1] was an assistant professor of Ob/Gyn at the University of
Wisconsin, School of Medicine and Public Health, while serving as the
associate medical director of Planned Parenthood of Wisconsin.
[WI Doctor #2] is the director of the Ryan Fellowship and a member of
the Ob/Gyn faculty at the University of Wisconsin, School of Medicine
and Public Health, and also works at Planned Parenthood of Wisconsin.
[MI Doctor] is both an associate professor in University of Michigans
Ob/Gyn department and medical director for Planned Parenthood in Ann
Arbor.
Chapter VII Redaction Key:
[Abortion Doctor #1] is an abortion provider in Nebraska and Maryland.
[Abortion Doctor #2] is an abortion provider in Colorado.
[Abortion Doctor #3] is an abortion provider in Texas.
[Dr. Administrator] is a faculty member at the University of New Mexico.
[Doctor #1] is an employee of Southwestern Womens Options and a
faculty member of the University of New Mexico.
[Clinic B Staff #1] is an employee of a late-term abortion clinic in
Maryland for [Abortion Doctor #1].
[Clinic B Staff #2] is an employee of a late-term abortion clinic in
Maryland for [Abortion Doctor #1].
[Clinic B Staff #3] is an employee of a late-term abortion clinic in
Maryland for [Abortion Doctor #1].
[Clinic B Staff #4] is an employee of a late-term abortion clinic in
Maryland for [Abortion Doctor #1].
[Employee #1] is an employee of a late-term abortion clinic in Texas for
[Abortion Doctor #3].

liii

[Employee #2] is an employee of a late-term abortion clinic in Texas for

[Abortion Doctor #3].
[Employee #3] is an employee of a late-term abortion clinic in Texas for
[Abortion Doctor #3].
[Employee #4] is an employee of a late-term abortion clinic in Texas for
[Abortion Doctor #3].
[Patient #1] is a former patient of [Abortion Doctor #3].
Chapter VIII Redaction Key:
[PP Witness #1] is an abortion provider in Los Angeles, California, an
executive with Planned Parenthood Federation of America (PPFA) who is
in charge of the PPFA Manual of Medical Standard and Guidelines.
[PP Witness #2] is a manager of research projects at Planned Parenthood
Gulf Coast.
[PP Witness #3] is a university professor, an abortion provider and serves
on the PPFA National Medical Committee.
[PP Witness #4] works for the Consortium of Abortion Provider Services
at PPFA which provides technical assistance to PPFA affiliate clinics.
[PP Doctor #1] is an abortion provider in Los Angeles, California, who
also works for the Medical Directors Council.
[PPGC Abortion Services Official] is a manager of abortion services at
PPGC.
[PPFA Executive] works for the Medical Standards Department at PPFA.
[PPFA Medical Officer #1] is a PPFA official who was responsible for
medical issues
[PPFA Medical Officer #2] is a PPFA official who was responsible for
medical issues
[PPFA Lawyer] is a legal official at PPFA.
[CRR lawyer] works for the Center for Reproductive Rights.
[ANSIRH lawyer] works for Advancing New Standards in Reproductive
Health.
liv

[NARAL executive] works for the Policy department at the National

Abortion and Reproductive Rights Action League.
[StemExpress Founder and CEO] refers to the founder and CEO of
StemExpress.
[Abortion Doctor] is any doctor who provides abortions.
[Researcher FT] refers to any person who is involved in fetal tissue
transactions.
[Procurement Technician] refers to any person who procures fetal tissue.

lv

Acknowledgments
The Chairman wishes to acknowledge important contributions made to the Panels work.
The General Accounting Office was very generous in providing a detailee, Pierre Kamga, a
Senior Auditor who provided extraordinary guidance on all matters related to forensic
accounting. Dr. David Prentice of the Charlotte Lozier Institute tutored the Members and Staff
alike on the latest trends in biomedical research and helped us sharpen our thinking about the
ethical issues associated with the use of abortive fetal tissue. Lastly, the Members of the Panel
and their staffs performed beyond the normal, intense work-load of the House of
Representatives.

lvi

I.

Congress Establishes the Select Investigative Panel

A. Summary
David Daleiden, an investigative journalist, released undercover videos beginning in July
2015, recorded while posing as the head of a company interested in the fetal tissue procurement
business. In numerous meetings with abortion providers and companies involved in the transfer
of fetal tissue, Daleiden recorded doctors, executives, and staff-level employees discussing
various aspects of the fetal tissue procurement industry. The videos and other materials that
Daleiden acquired, detailed the relationship between fetal tissue procurement companies, such as
Advanced Bioscience Resources, DaVinci Biologics, and StemExpress, and several abortion
clinics.
The expos followed an investigation Daleiden conducted through a not-for-profit group
he founded, the Center for Medical Progress (CMP), identified on its website as a group of
citizen journalists dedicated to monitoring and reporting on medical ethics and advances.1
CMPs first project, the Human Capital investigation, took almost three years30 months.
Working under the guise of a tissue procurement business in order to gain access to the top levels
of the abortion giant Planned Parenthood, Daleiden, Susan Merritt, and other activists on the
investigation recorded numerous videos documenting conversations in which Planned
Parenthood executives discussed the procurement of fetal tissue (the body parts of aborted
fetuses).2
The investigation culminated with the release of eleven videos documenting the practices
of local abortion clinics and groups affiliated with the fetal tissue procurement industry. While
most are familiar with the clips, Daleiden and his colleagues filmed hundreds of hours of
meetings and conversations. According to the Washington Post, they filmed 500 hours of footage
at two conferences alone.3
Multiple clips show abortion clinic doctors and executives admitting that their fetal tissue
procurement agreements are profitable for clinics and help keep their bottom line healthy.
Multiple clips also show them admitting that they sometimes changed the abortion procedure in
order to obtain a more intact specimen,4 including relying on the illegal partial-birth abortion
procedure.5 Planned Parenthood Federation of America (PPFA) also revealed that they
intentionally had not set a policy about remuneration for fetal tissue because the headlines

Center for Medical Progress, About Us, http://www.centerformedicalprogress.org/about-us/.

Center for Medical Progress, Human Capital, http://www.centerformedicalprogress.org/human-capital.
3
Sandhya Somashekhar, Meet the Millennial Who Infiltrated the Guarded World of Abortion Providers, Wash. Post,
Oct. 14, 2015, available at https://www.washingtonpost.com/national/meet-the-millennial-who-infiltrated-theguarded-world-of-abortion-providers/2015/10/14/25aaf862-678b-11e5-9223-70cb36460919_story.html.
4
Center for Medical Progress, Human CapitalEpisode 3, http://www.centerformedicalprogress.org/blog/page/5/.
5
Center for Medical Progress, CMP Reply to PPFA Cecile Richards Video Statement,
http://www.centerformedicalprogress.org/blog/page/6/.
2

would be a disaster.6 While the organizations executives told affiliates to think, New York
Times headline if this went badly,7 at the end of the day, they thought this is a good idea.8
Congress responded to the videos by holding hearings and initiating investigations. In
particular, the Energy and Commerce Subcommittee on Oversight and Investigations initiated an
investigation of fetal tissue transfers. The Committee on Oversight and Government Reform and
the Judiciary Committee conducted hearings and also initiated investigations.
On October 7, 2015, Rep. Virginia Foxx (NC-5) managed the floor debate for H. Res.
461, a proposal for a centralized and comprehensive congressional investigation. During debate,
Rep. Mimi Walters (CA-45) noted, This resolution would create a select panel to investigate a
number of claims related to Planned Parenthoods activities involving abortion and fetal tissue
procurement. Like many Americans, I was horrified by the recent videos which depicted Planned
Parenthood employees callously discussing the trafficking and sale of aborted babies tissues and
organs. Rep. Marsha Blackburn (TN-7) summarized:
I want to clearly state this is about getting answers of how we treat
and protect life in this country. The select panel will act to centralize
the investigations that are at the Energy and Commerce Committee,
Judiciary and Oversight Committees, and bring it all under one
umbrella. Over the past several weeks, we have had lots of serious
questions. They are troubling questions that have been asked. I think
that the investigations we have had have raised a lot of those
questions. It is imperative that we centralize these operations and
bring it together under one umbrella.9

Center for Medical Progress, Press Release, Top Planned Parenthood Exec Agrees Baby Parts Sales A Valid
Exchange, Some Clinics Generate a Fair Amount of Income Doing This,
http://www.centerformedicalprogress.org/2015/09/top-planned-parenthood-exec-agrees-baby-parts-sales-a-validexchange-some-clinics-generate-a-fair-amount-of-income-doing-this/.
7
Center for Medical Progress, Transcript, 13, (Feb. 27, 2015), http://www.centerformedicalprogress.org/wpcontent/uploads/2015/05/PPCAPSDVDfinal.pdf.
8
Center for Medical Progress, Transcript, 12-13, 15, (Mar. 18, 2015)
http://www.centerformedicalprogress.org/wp-content/uploads/2015/05/PPCAPSDVDVRfinal.pdf.
9
161 Cong. Rec. H6869-6872 (daily ed. Oct. 7, 2015).
6

Congress passed H. Res 461 by a recorded vote of 242 yeas and 184 nays.10 Rep. Blackburn was
named Chairman of the Panel. The Panels membership is as follows:

Select Investigative Panel

Marsha Blackburn (Tennessee - 07)
Chairman

Republican Members
Joseph Pitts (Pennsylvania - 16)

Democratic Members
Janice Schakowsky (Illinois - 09),

Diane Black (Tennessee - 06)

Larry Bucshon (Indiana - 08)
Sean Duffy (Wisconsin - 07)
Andy Harris (Maryland - 01)
Vicky Hartzler (Missouri - 04)
Mia Love (Utah - 04)

Jerrold Nadler (New York - 10)

Diana DeGette (Colorado - 01)
Jackie Speier (California - 14)
Suzan DelBene (Washington - 01)
Bonnie Watson Coleman (New Jersey - 12)

Ranking Member

B. Center for Medical Progress Videos Raise Serious Issues

The Panel did not design its investigation to prove or disprove the credibility of tapes
released by the Center for Medical Progress (CMP). The CMP engaged in a multi-year series of
investigations that involved journalists posing as persons interested in growing a fetal tissue
procurement business. The journalists attended conferences, befriended numerous persons in the
abortion industry, and obtained documents from existing companies involved in fetal tissue
procurement. During much of this undercover activity, the journalists wore unseen video
recording equipment. Beginning on July 14, 2015, the CMP began to release compilations of
these videos to the public. The content was alarming and troubling to many. Some said the
videos were doctored or highly edited. The Panel viewed the videos as a series of serious
claims made by a citizen advocacy group. Thus, the Panel obtained and viewed hours of unedited
footage of the CMP videos and took notice of the issues they raised. Below are the Panels
summaries of eleven videos released by CMP. The titles of each video are the CMP title for the
video.
1. Planned Parenthood Orange County Changes Abortions to Harvest Intact Fetuses for
Local Companys Fetal Products sales
The Panel took notice that this video raised the issue of infants born alive during lateterm abortion procedures. The video showed a discussion between the medical director of
Planned Parenthood of Orange and San Bernardino Counties and undercover journalists during
which the medical director admitted that her affiliate does not use digoxin. This chemical is used
to kill the fetus in later 2nd-trimester abortions and prevent a live birth. Middleman companies
10

Id. at H6879.

such as Da Vinci Biologics, LLC (who gave large donations to this Planned Parenthood
affiliate), can only harvest organs from fetuses who were aborted without digoxin because of the
poisonous effect of the chemical on fetal cells. This video prompted us to investigate late-term
abortion practices in the United States and what care is provided to infants who are born alive
during late-term abortion procedures. See Chapter VII.
2. Planned Parenthood Ally National Abortion Federation Suggests Group Purchasing
Program for Fetal Parts, Payments A Win-Win for Clinics
The Panel took notice that this video raised the issue of profiting from the sale of fetal
parts, a violation of 42 U.S.C. 289g-2. In this video, an employee of the National Abortion
Federation (NAF), a network of abortion clinics, suggested a group-purchasing program for
fetal tissue and that payments from middleman companies to NAF affiliated clinics would be a
win-win. This video prompted the Panel to seek accounting records from clinics and
middleman companies in order to discover if the statute preventing profit needed further
examination. See Chapter V.
3. Planned Parenthood Houston Admits Accounting Gimmicks Hide Baby Parts Sales,
Invoices Charge Thousands of Dollars
The Panel took notice that this video again raised the issue of illegal profiting from the
sale of fetal parts. In this video, the director of research at Planned Parenthood Gulf Coast tells
undercover journalists about accounting gimmicks which can be used to hide the sale of fetal
parts. The director of research even admitted that her department contributes so much to the
bottom line of our organization here. Again, this prompted the Panel to seek accounting
records in order to analyze the transactions that were taking place between abortion clinics,
middleman companies, and buyersusually universities. See Chapter VI.
4. Planned Parenthood TX Abortion Apprentice Taught Partial-Birth Abortions to Strive
For Intact Baby Brains
The Panel took notice that this video raised the issue of changing abortion procedures in
order to harvest the most intact fetal parts. Changing the timing or method of the abortion
procedure is illegal under U.S.C. 289g. A Planned Parenthood doctor, who admitted she was
trained by PPFAs senior medical advisor, described using a partial-birth abortion technique to
harvest fetal organs. She told undercover journalists that she will sometimes use ultrasound
guidance to convert a 2nd-trimester fetus to a feet-first breech presentation: Thats what [PP
Doctor] was telling us, was it really makes a difference for tissue collection at PPLA. This
prompted the Panel to interview and depose abortion providers who it thought might be involved
with fetal tissue collection, as well as subpoena and examine clinic manuals and procedure
guides that relate to fetal tissue procurement methods. See Chapter VIII.
5. Top Planned Parenthood Exec Agrees Baby Parts Sales A Valid Exchange, Some
Clinics Generate a Fair Amount of Income Doing This
The Panel took notice that this video again raised the issue of illegal profiting from the
donation of fetal parts, as well as the apparent endorsement of these practices by senior Planned
4

Parenthood executives. In this video, the National Director for the Consortium of Abortion
Providers (a key committee within PPFA that shapes abortion policy) referred to fetal tissue
payments as donation remuneration. She also admitted that she had been talking to the
executive director of the National Abortion Federation, were trying to figure this out as an
industry, about how were going to manage remuneration, because the headlines would be a
disaster. This prompted the Panel to interview top Planned Parenthood executives in order to
ascertain their understanding of federal and state regulations, as well as their protocols of
compliance surrounding the transfer of fetal tissue, in addition to seeking accounting
information. See Chapter VIII.
6. Planned Parenthood Baby Parts Vendor Advanced Bioscience Resources Pays Off
Clinics, Intact Fetuses Just Fell Out
The Panel took notice that this video raised the issue of illegal profiting and born-alive
infants. The former director of Planned Parenthood of the Pacific Southwest seems to affirm
undercover journalists offer to pay for tissue. When they say, We return a portion of our fees to
the clinics, the director responds eagerly, Right, get a toe in and make it, make a pro
alright. The video also featured the Procurement Manager at ABR, who described situations
where enough dilation occurred to procure an intact fetus. I literally have had women come in
and theyll go in the O.R. and theyre back out in 3 minutes, and Im going, Whats going
on? Oh yeah, the fetus was already in the vaginal canal whenever we put her in the
stirrups, it just fell out. This prompted the Panel to investigate late-term abortion practices.
See Chapters V and VII.
7. Planned Parenthood Baby Parts Buyer StemExpress Wants Another 50 Livers/Weeks,
Financial Benefits for Abortion Clinics
The Panel took notice that this video raised the issue of a callous tone and unethical
behavior towards scientific research, late-term abortions, and fetal tissue procurement. CEO of
StemExpress told undercover journalists about shipping aborted fetal cadavers to researchers
after abortions and the reactions of scientists:
Tell the lab its coming! So they dont open the box and go, Oh
God! [laughter] So yeah, so many of the academic labs cannot fly
like that, theyre not capableIts almost like they dont want to
know where it comes from. I can see that. Where theyre like, We
need limbs, but no hands and feet need to be attached. And
youre like, ? Or they want long bones, and they want you to take it
all off, like, make it so that we dont know what it isBut we know
what it is. I mean, [laughter], but their lab And their lab techs
freak out, and have meltdowns.
The CEO was also asked what would make her lab happy, to which she responded, Another
50 livers a weekWere working with almost like triple digit number clinics, she explains,
and we still need more. She later noted, Planned Parenthood has volume, because they
are a volume institution. She also suggested that abortion clinics profit from fetal tissue
5

donation. This prompted the Panel to examine the attitude towards fetal tissue donation. See
Chapter V.
8. Intact Fetuses Just a Matter of Line Items for Planned Parenthood TX Mega-Center
The Panel took notice that this video raised the issue of Planned Parenthood affiliate
clinics breaking their own protocols in order to contract and conduct business with fetal tissue
procurement companies. The director of research at Planned Parenthood Gulf Coast told
undercover journalists: Where we probably have an edge over other organizations, our
organization has been doing research for many many years. When researchers need a
specific part from the aborted fetus, she says, We bake that into our contract, and our
protocol, that we follow this, so we deviate from our standard in order to do that. She also
admitted that some doctors change their procedure in order to procure the most intact specimen.
This prompted the Panel to study the regulations around fetal tissue procurement and examine
how closely those regulations are being followed. She also said of budgeting for fetal tissue,
Its all just a matter of line items. This prompted the Panel to see how well Planned
Parenthood executives understand the federal regulations surrounding fetal tissue. See Chapter
VI.
9. Planned Parenthood VP Says Fetuses May Come Out Intact, Agrees Payments Specific
to the Specimen
The Panel took notice that this video again raised the issue of born-alive infants because
Planned Parenthood employees discussed delivering intact fetuses after an abortion. At Planned
Parenthood of the Rocky Mountains, [Abortion Doctor] said, Sometimes, if we get, if someone
delivers before we get to see them for a procedure, then we are intact. Again, because this
affiliate does not use the feticide digoxin in 2nd trimester procedures, there is the potential that
intact deliveries are born alive. This prompted the Panel to investigate late-term abortion
procedures. She also said she would need to train doctors to change the abortion procedure in
order to harvest the most intact brains if PPRM were to partner with the fake tissue procurement
company. And finally, [Abortion Doctor] said, I think a per-item thing works a little better,
just because we can see how much we can get out of it. This prompted the Panel to see if
clinics were profiting from the transfer of fetal tissue, a violation of federal law. See Chapters
VII and VIII.
10. Second Planned Parenthood Senior Executive Haggles Over Baby Parts Prices, Changes
Abortion Methods
The Panel took notice that this video again raised the issue of illegal profit. Another
Planned Parenthood executive, the President of the Medical Directors Council, bargained with
undercover journalists over the price of fetal tissue. You know, in negotiations whoever
throws out the figure first is at a loss, right? She explains, I just dont want to lowball. If
Planned Parenthood loses money as they say they do by participating in fetal tissue programs,
then lowballing wouldnt be a factor in contract negotiations. And even though she insists,
Were not in it for the money, she says, But it has to be big enough that its worthwhile for
me. This again prompted the Panel to seek accounting records and other records relating to
Planned Parenthoods fetal tissue programs. See Chapter VIII.
6

11. Planned Parenthood Uses Partial-Birth Abortions to Sell Baby Parts

The Panel took notice that this video raised multiple issues: illegal profiting, changing the
abortion procedure in order to procure a better specimen, the possible use of partial birth
abortion, and the disregard of federal regulations. In the video, the Senior Medical Advisor to
Planned Parenthood, discusses how she changes the abortion procedure to procure an intact
calvarium (upper skull): Weve been very good at getting heart, lung, liver, because we
know that, so Im not gonna crush that part, Im gonna basically crush below, Im gonna
crush above, and Im gonna see if I can get it all intact. But I will tell you that behind
closed doors these conversations are happening with the affiliates. When asked about
Planned Parenthoods position on fetal tissue procurement, she tells the journalists, behind
closed doors these conversations are happening with the affiliates. She stressed that Planned
Parenthood is treading very carefully around the issue in order to avoid headlines, a frequently
repeated phrase in conversations among executives. This prompted the Panel to investigate lateterm abortion practices to see if they were being modified to procure tissue, as well as to
interview multiple Planned Parenthood executives. See Chapters VII and VIII.
C. The Panel Forms an Investigative Plan
On March 10, 1993, the House debated two competing amendments to H.R. 4, the
National Institutes of Health Revitalization Act of 1993. The amendments, one offered by Rep.
Bliley and one by Rep. Waxman, focused on safeguards governing the donation of fetal tissue
for transplantation and for research. The House passed the Waxman Amendment to H.R. 4, the
National Institutes of Health Revitalization Act of 1993. That Amendment includes the
provisions codified as 42 U.S.C. 289g-2(a) and (e)(3):
42 U.S.C. 289g-2(a) states It shall be unlawful for any person
to knowingly acquire, receive, or otherwise transfer any human
fetal tissue for valuable consideration if the transfer affects
interstate commerce.
42 U.S.C. 289g-2(e)(3) The term valuable consideration
does not include reasonable payments associated with the
transportation, implantation, processing, preservation, quality
control, or storage of human fetal tissue.
During floor debate it was repeated over and over by supporters of the Waxman
Amendment that fetal tissue may not be sold.11 Rep. Morella expressed her support for the
legislation because fetal tissue could not be sold.12 Rep. Waxman himself said:
This amendment that I am offering as a substitute would enact the
most important safeguards, and those are the safeguards to prevent
any sale of fetal tissue for any purpose, just not for the purpose of
11
12

139 Cong. Rec. H1099 (1993) (statement of Rep. John Edward Porter in support of the Waxman Amendment).
Id. (statement of Rep. Connie Morella in support of H.R. 4 and the Waxman Amendment).

research. It would be abhorrent to allow for a sale of fetal tissue and

a market to be created for that sale.13
The floor debate corroborates the Committee Report language. The Report from the
Committee on Energy and Commerce stated, Section 498B prohibits the purchase of human
fetal tissue as well as the solicitation or acceptance of directed fetal tissue donations.14 The
Committee prohibition on the sale of fetal tissue is described as making the transfer of fetal
tissue parallel with donation of other organs under the Organ Procurement and Transplantation
Act.15 The Committee Report adds, however, Indeed the Committee has dealt with fetal tissue
more restrictively . . . . 16 The Committee intent is to disallow payment for procurement of any
organs.
The intent of the statute is best understood through a simple contrast between two modes
of transferring fetal tissue from one entity to another. With the first, an abortion clinic or
middleman Procurement Business transfers tissue to a researcher, and the researcher may
reimburse the abortion clinic or Procurement Business for its reasonable costs incurred by the
transportation, processing, preservation, and quality control of the tissue. With the second, the
payment from the researcher exceeds those reasonable costs, enabling the abortion clinic or
Procurement Business to make a profit, and thus violates the statute.

Not a violation of 289g-2

Payment

Costs

Zero

Violation of 289g-2

Payment

Costs

Profit

The congressional intent of the Waxman Amendment served as a guide for the Panels
investigative plan. The core question became the following: If fetal tissue is transferred from one
entity to another, does the transfer violate the intent of 289g-2? To answer this question, the
panel identified four business. These are:
(1) The Middleman Model. This model comprises a middleman and tissue procurer who
obtains tissue directly from a source such as an abortion clinic or hospital and then transfers
the tissue to a customer, usually a university researcher.

13

Id. (statement of Rep. Waxman).

H.R. Rep. No. 103-28 at 76 (1993).
15
Pub. L. No. 98-507, 98 Stat. 2339 (1984).
16
H.R. Rep. No. 103-28 at 76 (1993).
14

(2) The University/Clinic Model. This model comprises a particular university that has formed
a close relationship with a nearby abortion clinic and regularly acquires tissue from that
clinic for research purposes.
(3) The Biotech Company/Clinic Model. This model comprises a close relationship between a
particular biotech company and one or more nearby clinics.
(4) The Late-Term Clinic Model. This model is of particular concern due to the intersection of
late-term abortions, the potential for live births during the abortion procedure, and the
transfer of tissues or whole cadavers from that clinic to research entities.
The Panel sought information from the following entities. Scientists from Harvard
University and Pfizer provided bipartisan, off-the-record informational briefings for staff which
gave a candid view into their view of fetal tissue research.
Bancorp StemExpress bank
24. Germantown Reproductive
Health Services
25. Harvard University Provided
Briefing
26. HHS
27. Holy Cross Germantown
Hospital
28. InVivo Therapeutics
29. [Abortion Doctor #1] (Document
Production and Deposition)
30. Life Technologies
31. Maryland Board of Physicians
32. Montgomery County Department
of Fire and Rescue Services
33. Montgomery County Emergency
Communications Center
34. Montgomery County Police
Department
35. NAF
36. Neuralstem
37. NIH
38. Northland Family Planning
39. Novartis
40. Novogenix Labs
41. Oregon Health Sciences
42. Pfizer Provided Briefing
43. Presidential Womens Center
44. Q Therapeutics
45. Saneron CCel Therapeutics, Inc.
46. Former Accountant StemExpress

1. Advanced Bioscience Resources,

Inc.
2. Albert Einstein College of
Medicine
3. American Academy of Pediatrics
4. American Association for the
Advancement of Science
5. American College of
Obstetricians and Gynecologists
6. American Type Culture
Collection
7. Anatomic Gift Foundation
8. Association of American
Medical Colleges
9. Baylor
10. Bioarray Therapeutics
11. Buffalo Biosciences
12. Butler Medical Transport
13. Camelback Family Planning
14. Capital Biosciences
15. CEO StemExpress
16. Cedar River Clinics
17. Colorado State University
18. [Dr. Administrator] University of
New Mexico
19. [MO Doctor #2]
20. [NM Research Doctor]
21. Dv Biologics
22. Family Planning Specialists
Medical Group
23. Five Star
9

47. SciKon
48. Scinto Group,
LLP StemExpress accountant
49. Shady Grove Adventist Hospital
50. Southwestern Womens Options
51. Stem Cell Innovations
52. StemCells, Inc.
53. StemExpress
54. The Center for Medical Progress
(CMP)
55. CEO and Chairman, AOL, Inc.

58. University of Michigan

59. University of Minnesota
60. University of Texas
61. University of Wisconsin
62. University of California, San
Diego
63. University of New Mexico
64. University of Washington Birth
Defects Research Laboratory
65. U.S. Department of Justice
66. University of Southern California
Keck
67. Womens Health Specialists
68. Yale University

56. County of Orange, State of

California
57. University of Colorado

The Panel started its inquiry into the middleman or tissue broker model, the primary business
model for the transfer of human fetal tissue. The statute raises several fundamental questions
about this model as displayed by the graphic below.

Middleman
Procurement
Business

Abortion Clinic
(1) Receives
payment for fetal
tissue. How
much?

$$$
(2) Reasonable
costs? How
much?

(1) Pays abortion

clinic for fetal
tissue? How
much?
(2) Receives
payment from
researcher? How
much?
(3) Reasonable
costs? How much?

10

Researcher
Pays Procurement
Business for fetal
tissue? How
much?

$$$

D. Middleman Investigative Work Plan Overview

The Panel relied upon the advice of a forensic accountant to formulate an investigative
work plan. The statute (Section 289g-2) states that the term valuable consideration does not
include reasonable payments associated with the transportation, implantation, processing,
preservation, quality control, or storage of human fetal tissue. The Panel relied on generally
accepted accounting standards, which defined payments made (including costs incurred) that are
reflected as expenses, and payments received that are reflected as revenue (or income, from
selling a product or service). Together these formed the Panels basis for seeking accounting
records of the business transactions of the fetal tissue procurement middleman companies, the
abortion clinics from which they harvested fetal tissue, and the customers that purchased fetal
tissue. The Panel sought to understand the transactional data, reflected on income statements and
balance sheets. Also, the Panel relied upon the requirement that nonprofit entities comply with
Internal Revenue Service (IRS) requirements to keep records that clearly show their income and
expenses in order to substantiate deductions and claims made on their tax returns.
For the Panel to complete its review and determine the extent to which an entity did not
receive valuable consideration allowed by the statute (or violated the statute), a thorough
examination of the accounting records is necessary. Payments made and/or received as described
in the preceding paragraph are embedded in accounting records. Each time a company makes a
financial transaction, a paper trail is generated, also known as a source document. These source
documents include but are not limited to cancelled checks, original invoices, sales receipts, bank
transaction records, leases & contracts, purchase orders, etc. These source documents form the
basis to substantiate any assertions made by an entity, through its financial or accounting records
(including a trial balance report, an income statement or records of profit and loss, a statement of
cash flow and a balance sheet). The Panel sought such documentation, but many entities refused
to comply, even with lawful congressional subpoenas.
The Panels document requests and subpoenas reflected these accounting standards: In
order to do a forensic examination of accounting and financial records, those financial records
have to be completely presented and handed over to the auditors, examiners, or investigators.
The responsibility to substantiate entries, deductions, claims, or other assertions made on the
financial records (arising through review of the records) is on the entity providing the
documentation. Without sufficient and appropriate substantiation, accounting principles view
such records as inaccurate, incomplete, invalid, or unreliable.
Thus, the Panel was able to reach partial conclusions about the sufficiency of the statute
that governs fetal tissue transfers. The Panel has made criminal referrals to law enforcement
agencies that have additional investigative tools. The graphic chart below illustrates the Panels
work plan for an examination of accounting documentation.

11

STATUTE
Unlawful To
Sell/Transfer Human
Fetal Tissue For Profit

PROFIT
Sales Revenue
In Excess of Allowed
Costs

ENTITIES INVOLVED
Abortion Clinics (Supplier)
Procurement Businesses
(Middleman)
Research Institutions
(Customer)

RECORDS NEEDED

RECORDS OBTAINED

For Analysis

Partial

From

Records

Revenue from Sale

of Fetal Tissues

Abortion Clinics

Costs / Expenses
Related to Fetal
Tissue Procurement

Middleman

Customer

Records of Fetal
Tissue purchases

12

No.
Identified

47

294

Records
Requested From

Records
Received From

II.

Applicable Laws, Regulations, and Commissions

Chapter II Redaction Key:

1. [PP Witness #1] is an abortion provider in Los Angeles, California, an executive
with Planned Parenthood Federation of America (PPFA) who is in charge of the
PPFA Manual of Medical Standards and Guidelines.
2. [PP Doctor #1] is an abortion provider in Los Angeles, California, who also
works for the Medical Directors Council.
Given the breadth of the Select Investigative Panels authorization, the Panel examined
numerous federal and state laws which can be grouped into four broad categories, with some
overlap: (1) laws protecting human research subjects and patient privacy; (2) laws regulating
anatomical gifts for transplantation, therapy, research, and education; (3) laws protecting lateterm and born-alive infants; and (4) laws pertaining to public funding for fetal tissue research
and abortion providers.
Laws protecting human research subjects and privacy are rooted in the principles set forth
in the Belmont Report. Research subjects must be respected as autonomous persons, researchers
must adhere to the Hippocratic ideal, and the benefits of research must outweigh the risks to
human research subjects. The Panel heavily examined the legal and ethical importance of
informed consent.
Laws regulating anatomical gifts are also heavily centered on the need for informed
consent. Additionally, federal and many state laws explicitly prohibit the sale of human body
parts. Laws protecting late-term unborn infants and infants born alive during abortion procedures
recognize that the right to an abortion does not equal the right to a dead child. Federal laws
prohibit a specific abortion procedure that occurs seconds before live birth and explicitly provide
that infants born alive enjoy all of the constitutional rights available to other Americans.
Finally, laws pertaining to public funding for fetal tissue research and abortion providers
need reforming. In particular, while federal law contains numerous restrictions on public funding
for abortion, abortion providers receive millions of federal dollars ostensibly for other purposes.
Government investigations and whistleblower testimonies have revealed that abortion providers
often fail to separate public funding from abortion-related costs.
A. Laws Protecting Human Research Subjects and Patient Privacy
1. The Belmont Report
The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research was created on July 12, 1974, with the passage of the National Research
Act.17 The Act was largely a response to the reprehensible Tuskegee Syphilis study, in which
17

P.L. 93-348.

13

African-American men were asked to participate without informed consent. These men were not
given adequate treatment for their disease, even after penicillin became the accepted drug for
treating syphilis in 1947. In 1972, an advisory panel concluded that the Tuskegee Study was
ethically unjustified.18
The National Commission was tasked with identifying the basic ethical principles that
should underlie the conduct of biomedical and behavioral research involving human subjects
and developing guidelines which should be followed to assure that such research is conducted
in accordance with those principles.19 The Commissions work culminated in the issuance of the
Belmont Report. This seminal report set forth three principles of biomedical research:
(1) Respect for persons, with consideration given to
individuals autonomy. This principle underlies the
requirement of obtaining a patients informed consent.
(2) Beneficence, reflecting the Hippocratic ideal of doing no
harm.
(3) Justice, with potential benefits of research balanced against
the risks to subjects (i.e., people).
The Belmont Reports relevance to the Panels investigation was clear during the Panels
hearing on Bioethics and Fetal Tissue. Rep. Vicky Hartzler (MO-4) addressed an important
statement in the Belmont Report regarding informed consentthat inducements [to consent]
that would ordinarily be acceptable may become undue influences if the [research] subject is
especially vulnerable.20 She asked an ethics expert if a form known to be widely used by
abortion clinics to obtain a mothers consent to donate fetal tissue complied with HHSs
mandate against inducement.21 The form stated that [r]esearch using the blood from pregnant
women and tissue that has been aborted has been used to treat and find a cure for such diseases
as diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS.22
The witness agreed that this was an important question because the idea of the
promise of cures found in the form was a very powerful motivator.23 The witness also
18

See The Tuskegee Timeline, CDC, http://www.cdc.gov/tuskegee/timeline.htm.

See The Belmont Report, Office of the Sec., Ethical Principles and Guidelines for the Protection of Human
Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, Summary (1979), http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/.
20
The Belmont Report, Office of the Sec., Ethical Principles and Guidelines for the Protection of Human Subjects of
Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(1979), http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/.
21
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong. 77 (unedited transcript) (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
22
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong. Majority exhibit A-3 (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-20160302-SD030.pdf (emphasis
added).
23
Id.
19

14

indicated that the consent form was deficient in other ways: The concern I have is that the
standards that we have typically for fetal tissue donation are just absent here. And so in addition
to the voluntariness, there is just the thoroughness of the consent [that] seems to be missing in
this form.24
A researcher invited by the Minority during the hearing agreed, stating that the form
would not have made it past his IRB.25 The testimony provided by witnesses invited by both
the Majority and Minority raised concerns that the principles embodied in the Belmont Report,
and later incorporated into federal regulations, are not being followed by abortion providers
seeking consent for the donation of human fetal tissue.
During the hearing, Rep. Mia Love (UT-4) expressed deep concern with the issue of
consent and minors. She stated: So, imagine [a] 14-year-old going into a clinic to undergo a
very invasive procedure without someone there that she trusts to walk her through, to make sure
that she is not being taken advantage of, to make sure that she is making the right decision.26
She asked, How can anyone be sure that that minor, under difficult circumstances, fully
understand[s] the long-term repercussions behind [her] decision when the current law wouldnt
even allow that minor to get behind the wheel of a vehicle?27 Dr. G. Kevin Donovan, a witness,
agreed that this presented a troubling problem.28
2. The Common Rule and IRB Regulations
In response to the Belmont Report, HHS and the FDA significantly revised their human
subjects regulations in 1981.29 The Common Rule30 applies to research projects that receive
funding from any one of 19 federal agencies. It requires three steps to be fulfilled before the
research can take place: 1) the human subject must give informed consent; 2) an Institutional
Review Board (IRB) must review the proposed research project; and 3) the institution
conducting the research must file an assurance of compliance with the federal agency that is
providing the funding. For fetal tissue, if the researchers would like access to the womans
medical information, then the HIPAA Privacy Rule applies, and she must give consent for that
information to be shared.
The rule lists several criteria for IRB approval, including the requirement that researchers
obtain the informed consent from their research subjects. There are eight basic elements of
informed consent under the Common Rule that shall be provided to each subject.31 The HHS
regulations also require an IRB to prepare and maintain adequate documentation of its
activities.32
24

Id. (testimony of Paige Cunningham).

Id. (testimony of Lawrence Goldstein).
26
Id.
27
Id.
28
Id. (testimony of G. Kevin Donovan).
29
45 C.F.R. 46; 21 C.F.R. 50; See Erin D. Williams, Cong. Research Serv., RL32909, Federal Protection for
Human Research Subjects: An Analysis of the Common Rule and its Interactions with FDA Regulations and the
HIPAA Privacy Rule 78 (2005).
30
45 C.F.R. 46.
31
45 C.F.R. 116.
32
45 C.F.R. 46.115(a).
25

15

The Panels investigation revealed evidence that the IRB process used by some fetal
tissue procurement companies is often grossly insufficient. For instance, on March 29, 2016, the
Panel issued a subpoena to BioMed IRB which required it to produce documents sufficient to
show BioMed IRBs ongoing oversight, within the definition of federal regulations, of any entity
involved with fetal research or transplantation of fetal tissue for which it issued an IRB
approval.33 BioMed IRBs executive director informed the Panel on April 4, 2016, that, in
regards to those records, there are none.34 This is an apparent direct violation of federal
regulations.
3. Presidential Commissions
Since 1974, public national bodies have had a role in the national debate surrounding
bioethics. These groups have grappled with topics ranging from human subject research to endof-life care to stem cell research. Their studies have most frequently been conveyed through
reports, policy proposals, and hearings. Furthermore, fetal tissue research has been a topic of
their conversations since the first commission.
In addition to the Belmont Report, the first group published a report called Research on
the Fetus (1975), in which they said their primary concern was research on the fetus . . . before,
during and after induced abortion. While they recommended that use of the dead fetus, fetal
tissue and fetal material for research purposes be permitted, several members of the commission
(both for and against abortion) argued that research on fetuses past viability was unethical. They
also recommended that the method of abortion should not be changed for research purposes and
that no financial inducements be offered to procure an abortion for research purposes.35
President Reagans Presidential Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research (1978-1983) added an important voice to
the discussion of euthanasia with their report Defining Death,36 which served as the basis for the
Uniform Determination of Death Act subsequently enacted by most states. Their report
Screening and Counseling for Genetic Conditions (1983)37 discussed in part the ethics of having
abortions based on the knowledge of the sex or various disabilities of the fetus.

33

Subpoena from Select Investigative Panel to Biomedical Research Institute of America (Mar. 29, 2016).
Email from Executive Director, Biomedical Research Institute of America, to Select Investigative Panel staff
(Apr. 4, 2016).
35
See Research on the Fetus, U.S. Dept. of Health, Ed., & Welfare, The National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research (1975),
https://videocast.nih.gov/pdf/ohrp_research_on_fetus.pdf.
36
See Defining Death: Medical, Legal, and Ethical Issues in the Determination of Death, Presidents Commission
for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1981),
https://repository.library.georgetown.edu/bitstream/handle/10822/559345/defining_death.pdf?sequence=1&isAllow
ed=y.
37
See Screening and Counseling for Genetic Conditions: The Ethical, Social and Legal Implications of Genetic
Screening, Counseling, and Education Programs, Presidents Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research (1983),
https://repository.library.georgetown.edu/bitstream/handle/10822/559349/geneticscreening.pdf?sequence=1&isAllo
wed=y.
34

16

The Advisory Committee on Human Radiation Experiments (1994-1995), created by

President Clinton, investigated human radiation experiments conducted from 1944-1974, while
his second commission, the National Bioethics Advisory Commission, set out in part to
familiarize professionals engaged in nonfederally-funded research with the ethical
considerations associated with conducting research involving human subjects.38
President George W. Bushs Presidential Council on Bioethics (PCBE) is perhaps most
renowned for the academic seriousness with which it approached bioethics. Guided by the belief
that respect for human life and advancing biotechnology were compatible, President Bush
appointed a diverse group of scientists and ethicists to the Council to advise him, particularly in
regard to embryonic stem cell research. President Bush was especially concerned that research
using embryonic stem cells, which he believed ended human lives, was unethical. He relied on
policy recommendations from the PCBE to promote bills prohibiting biomedical practices he
found morally objectionable. For example, the Fetus Farming Prohibition Act of 2006 was a
response to the PCBEs report Reproduction and Responsibility, whose policy recommendations
attempted to limit questionable practices, particularly by instituting (at least temporarily)
moratoriums on those affecting reproduction.39 The Fetus Farming bill made it a federal crime to
be involved in interstate commerce to acquire human fetal tissue knowing that a human
pregnancy was deliberately initiated to provide the tissue.40
The Panels research found thateven with the material produced by these
commissionsanswers to many questions were out of date or nonexistent. Of particular concern
are current practices in tissue and organ donation; research ethics and the revolution in
biotechnology; the ability of the regulatory agencies to address misconduct; and the role of law
enforcement. Many of the Panels questions directed to the Federal Drug Administration and the
National Institutes of Health could not be answered at all. The U.S. Department of Justice wrote
to the Panel that it had never conducted training on the criminal statute that makes profiting from
human fetal tissue sales a felony. The same letter could provide no example of attorney training
or convictions under the statute.
4. HIPAA Privacy Rule
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule
(Privacy Rule) protects all individually identifiable health information held or transmitted by a
covered entity or its business associate and calls this information protected health information
(PHI).41 PHI identifies an individual, or can reasonably be believed to be useful in identifying an
individual (e.g., name, address, birth date, Social Security number), and includes demographic
data relating to an individuals past, present, or future physical or mental health condition; the
provision of health care to the individual; or the past, present, or future payment for the provision
of health care to the individual.42
See Exec. Order No. 12975, Protection of Human Research Subjects and Creation of National Bioethics
Advisory Commission (1995), https://bioethicsarchive.georgetown.edu/nbac/about/eo12975.htm.
39
See Reproduction and Responsibility: The Regulation of New Biotechnologies, The Presidents Council on
Bioethics (2004), https://bioethicsarchive.georgetown.edu/pcbe/reports/reproductionandresponsibility/.
40
Pub. L. No. 109-242; 42 U.S.C. 289g-2.
41
45 C.F.R. 160.103.
42
Id.
38

17

A covered entity may not use or disclose an individuals PHI except as the Privacy Rule
permits or requires43 or as the individual or their representative authorizes in writing. HHS may
impose civil penalties on covered entities that fail to comply with the Privacy Rule. Further, both
a covered entity that discloses and any person who knowingly obtains PHI in violation of the
Privacy Rule can face criminal fines or imprisonment.44
The Panels investigation uncovered a series of business contracts between StemExpress,
a tissue procurement business (TPB), and several abortion clinics. These contracts included
provisions for the payment of fees by StemExpress to the abortion clinics for fetal tissue and
maternal blood. StemExpress then resold the fetal tissue and blood to researchers.
The Panels investigation indicates that StemExpress and Planned Parenthood Mar Monte
(PPMM), Planned Parenthood Shasta Pacific (PPSP), and Family Planning Specialists Medical
Group (FPS) (the abortion clinics) committed systematic violations of the HIPAA Privacy Rule
from about 2010 to 2015. These violations occurred when the abortion clinics disclosed patients
individually identifiable health information to StemExpress to facilitate the TPBs efforts to
procure human fetal tissue for resale.
From about 2010 to 2015, the abortion clinics (covered entities under HIPAA) permitted
employees of StemExpress (a non-covered entity) to enter their clinics and procure human fetal
tissue from aborted infants, obtain PHI about their patients, interact with patients, and seek and
obtain patient consent for tissue donation.45 StemExpress did not have a medically valid reason
to see, and the abortion clinics did not have a reason to provide, patients PHI. Instead, the
abortion clinics shared patients PHI with StemExpress in furtherance of contractual agreements
that financially benefited StemExpress and the clinics.46
The abortion clinics and StemExpress violated the HIPAA privacy rule because: (a) the
disclosures of patients PHI made by the abortion clinics and received by StemExpress were
neither required nor permitted under HIPAA, and in particular did not meet the exceptions for
cadaveric organ, eye or tissue transplantation or for research; (b) the consents for fetal tissue
donation ostensibly obtained by StemExpress from the abortion clinics patients did not
constitute sufficient authorizations for the disclosure of PHI; (c) the disclosures of patients PHI
made by the abortion clinics to StemExpress were not the minimum necessary disclosures to
facilitate the procurement of human fetal tissue from aborted infants; and (d) StemExpress is not
a business associate of the abortion clinics under HIPAA.
The abortion clinics could have directly consented their patients for tissue donation and
entered an agreement with StemExpress to provide a limited data set regarding the patients they
were seeing on a particular day.47 Instead, they violated the Privacy Rule by permitting
StemExpress to view the most intimate information about their patients.

43

45 C.F.R. 164.502(a).
Pub. L. No. 104-191; 42 U.S.C. 1320d-5-1320d-6.
45
See Clinic Procedures & Policies, produced by StemExpress, Exhibit 2.1.
46
See Standard Operating Procedure, produced by StemExpress, Exhibit 2.2.
47
See 45 C.F.R. 164.514(e).
44

18

These disclosures made by the abortion clinics to StemExpress were intentional and
purposeful.48 StemExpress employees were handed a patients medical chart by her healthcare
provider in blatant violation of the HIPAA privacy rule.
B. Laws Regulating Anatomical Gifts for Transplantation, Therapy, Research, and
Education
1. National Organ Transplant Act
The National Organ Transplant Act (NOTA)49 was enacted in 1984, providing for the
establishment of the Task Force on Organ Transplantation. The Act also authorized the Secretary
of Health and Human Services to make grants for organ procurement organizations, created the
Organ Procurement and Transplantation Network (OPTN), created the Scientific Registry of
Transplant Recipients, and created an administrative unit within HHS to administer these
activities. Importantly, NOTA included a criminal prohibition against the exchange of organs for
transplantation for valuable consideration.50
NOTA provides that [i]t shall be unlawful for any person to knowingly acquire, receive,
or otherwise transfer any human organ for valuable consideration for use in human
transplantation if the transfer affects interstate commerce. . . . Any person who violates [] this
section shall be fined not more than $50,000 or imprisoned not more than five years, or both.
The term human organ is defined to include fetal organs and subparts of organs.51
2. Uniform Anatomical Gift Act
The Uniform Anatomical Gift Act (UAGA), a model statute first available in 1968 and
most recently amended in 2009, was written to facilitate organ donation for transplantation,
therapy, research, and education by ensuring that state laws are consistent across the country. 52
The UAGA, adopted in every state in some form, includes stillborn babies and fetuses in the
definition of decedent for purposes of obtaining consent from a relative before the deceased
infants body is donated for experimentation or transplantation. In the UAGAs official notes, the
drafters explain that the inclusion of stillborn babies and fetuses ensures that they receive the
statutory protections conferred by this [act]; namely that their bodies or parts cannot be used for
transplantation, therapy, research, or education without the same appropriate consents afforded
other prospective donors.53
However, the notes also mention that states may choose to treat aborted fetuses

48

See 45 C.F.R. 164.502(a)(1)(iii).

98 P.L. 507; 98 Stat. 2339.
50
See U.S. Dept. of Health & Human Services, Selected Statutory and Regulatory History of Organ Transplantation,
http://organdonor.gov/about-dot/laws/history.html.
51
42 U.S.C. 274e.
52
See Revised Uniform Anatomical Gift Act (2006) (Last Revised or Amended in 2009), drafted by the National
Conference of Commissioners on Uniform State Laws,
http://www.uniformlaws.org/shared/docs/anatomical_gift/uaga_final_aug09.pdf.
53
Id.
49

19

differently, given the complicated legal, scientific, moral, and ethical issues which may arise.54
To date, eight states explicitly prohibit experimentation on aborted infants: Alabama, Arizona,
Idaho, Indiana, North Dakota, Ohio, Oklahoma, and South Dakota. In other states, restrictions on
the use of aborted infants remains for research are implicit.
For instance, New Mexicos Jonathan Spradling Revised Uniform Anatomical Gift Act
(Spradling Act)55 is based on the UAGA.56 The Spradling Act was enacted in 2007 to replace the
States existing Anatomical Gift Act57 with provisions mirroring the UAGA.58 In their new law,
New Mexico decided to follow the suggestion in the UAGA to treat aborted fetuses differently:
decedent means a deceased individual whose body or part is or may be the source of an
anatomical gift. It includes a stillborn infant and . . . a fetus but [does] not includ[e] a fetus that
is the subject of an induced abortion.59
Further, the Spradling Act provides that the Act applies to an anatomical gift or
amendment to, revocation of or refusal to make an anatomical gift, whenever made.60 In other
words, all anatomical gifts in the State of New Mexico must comply with this act, and the bodies
or body parts of aborted infants cannot be anatomical gifts.
The Panel learned, however, that the University of New Mexico (UNM) and the late-term
abortion clinic Southwestern Womens Options (SWWO) have an extensive history in which
SWWO provided fetal tissue to UNM researchers. SWWOs provision and UNMs acquisition
of and research using aborted infant remains appear to violate the Spradling Act. Any consents
ostensibly obtained by SWWO from mothers of aborted infants do not validate the donation of
their infants remains for research, because under the Spradling Act the bodies or parts of aborted
infants may not be anatomical gifts.
3. NIH Revitalization Act of 1993
Under the NIH Revitalization Act of 1993, the Secretary of the Department of Health and
Human Services (HHS) is permitted to conduct or support research on the transplantation of
human fetal tissue for therapeutic purposes, including tissue from aborted infants. The law
places numerous requirements on the acquisition of fetal tissue and on fetal tissue research,
including a requirement that the infants mother provide written consent. Further, when tissue is
obtained from aborted infants, a mothers consent to donate her infants remains must follow her
consent to the abortion procedure. The law also prohibits the alteration of the timing, method, or
procedures used to terminate the pregnancy . . . solely for the purposes of obtaining the tissue,
and requires abortion providers to perform the abortions in accordance with applicable State
law.61
54

Id.
N.M. Stat. Ann. 24-6B-1, et seq.
56
Revised Uniform Anatomical Gift Act.
57
N.M. Stat. Ann. 24-6A-1 et seq.
58
See Fiscal Impact Report, Revised Uniform Anatomical Gift Act 3 (Mar. 14, 2007),
https://www.nmlegis.gov/Sessions/07%20Regular/firs/HB1276.pdf.
59
N.M. Stat. Ann. 24-6B-2 (emphasis added).
60
N.M. Stat. Ann. 24-6B-3.
61
42 U.S.C. 289g-1.
55

20

Additionally, the Act provides that [i]t shall be unlawful for any person to knowingly
acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the
transfer affects interstate commerce. Further, the solicitation or acceptance of tissue as directed
donation for use in transplantation is prohibited. Persons or entities involved or engaged in
interstate commerce may not solicit or knowingly acquire, receive, or accept a donation of
human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such
tissue. Violations of this law can result in a fine or imprisonment for up to 10 years. Valuable
consideration is defined to exclude reasonable payments associated with the transportation,
implantation, processing, preservation, quality control, or storage of human fetal tissue.62
Laws regulating the donation of human organs, including human fetal organs, are
relevant for the Panels investigation, given the possibility that both tissue procurement
businesses (TPBs) and abortion providers are profiting from fetal tissue procurement. During the
Panels April 20, 2016, hearing, The Pricing of Fetal Tissue, Panel members asked witnesses to
examine evidence that payments paid by customers to a TPB for fetal tissue exceeded costs
incurred by the business by a factor of 300 to 700 percent. Further, the evidence did not
demonstrate that in many instances the compensated abortion clinics incurred any actual
costs.63
Witness Brian Lennon, a former federal prosecutor, stated that he didnt see [evidence]
in any of the [hearing] exhibits that abortion clinics had reasonable costs associated with fetal
tissue donation.64
C. Laws Protecting Late-Term and Born-Alive Infants
House Resolution 461 provided the Panel with jurisdiction to review [t]he practice of
providers of second and third trimester abortions, including partial birth abortion procedures that
may lead to a child born alive as a result of an attempted abortion, as well as [m]edical
procedures for the care of a child born alive as a result of an attempted abortion. The panel
investigated these issues in the context of two federal lawsthe Born-Alive Infants Protection
Act and the Partial-Birth Abortion Ban Act.
1. Born-Alive Infants Protection Act (BAIPA)
President George W. Bush signed the Born-Alive Infants Protection Act (BAIPA)65 in
2002, which passed by voice vote in the House of Representatives and with unanimous support
in the Senate. BAIPA clarifies that for purposes of all federal laws, the terms person, human
being, child, and individual include every infant who is born alive, regardless of whether
that birth is the result of labor, cesarean section, or induced abortion. BAIPA does not contain its
own criminal penalties or any other enforcement mechanism to hold abortion providers
accountable who fail to provide medical attention and care to infants born alive during an
62

42 U.S.C. 289g-2.
See generally The Pricing of Fetal Tissue: Hearing Before the Select Investigative Panel, The Comm. on Energy
and Commerce, 114th Cong. (2016).
64
Id. at 97.
65
1 U.S.C. 8.
63

21

abortion or attempted abortion.

The right to an abortion does not equal the right to a dead child. Through the enactment
of BAIPA, the United States Congress recognized that the right to abortion has limits, and is not
an absolute, ever-expanding right. In particular, the right to abortion does not extend so far as to
justify the denial of fundamental civil rights and protections to born, living human children.
During the Panels investigation, staff reviewed tissue procurement notes, email
exchanges among researchers, TPBs and abortion clinics, invoices, and moreall indicating that
researchers want fetal tissue from late-gestation infants that has not been tainted by feticidal
agents (e.g., digoxin).66 The Panel also learned that abortion providers may modify abortion
procedures, in apparent violation of the law, to increase the odds of getting an intact infant
cadaver (e.g., increase the number of laminaria placed in a patients cervix to achieve greater
dilation).67 Clearly, these factors increase the likelihood that unborn infants are born alive during
late second trimester abortions, and raise the question whether these infants civil rights are
recognized by abortion providers.
[PP Witness #3] acknowledged that a practitioner who does not intend to do an intact
procedure could nonetheless have an intact delivery that was not intended.68 Further, interviews
with second-trimester abortion providers revealed that, while they deny delivering live infants
during abortion procedures, they are inadequately prepared to care for an infant if a live birth
were to occur. When asked what Planned Parenthood would do if an infant was born alive during
an abortion procedure, [PP Witness #1] stated bluntly:
I can tell you that none of our Health Centers provide obstetrics care.
So they dont deliver babies. So they dont have anyone who can
provide care, nor do they know what that care is. . . . We dont
deliver babies at Planned Parenthood. . . . [O]ur affiliates dont
provide obstetrical care. So therefore, they dont know how to
manage a term infant or a premature infant.69
When Panel staff asked whether the protocol [should] be to call an ambulance right
away if a premature infant were born alive during an abortion, [PP Witness #1] stated [s]o
theres no protocol for this. Im not going to sit here and write a protocol.70

See, e.g., Documents produced by the University of New Mexico: procurement notes stating clinic now uses
digoxin only at 20 weeks [UNM 00049]; procurement notes lamenting that 25-week aborted infant treated with
digoxin: heart mushy; GI discolored +liver; skin loose; eyes discolored red [UNM 00004]; heavily redacted email
exchange, where UNM employee states that they will try to get later gestation lung; sometimes they can get up to
20-22 weeks, but unusual these days to get non-digoxin-exposed samples beyond 18 weeks [UNM 00910],
Exhibit 2.3.
67
See generally Interview of [PP Witness #1], before the Select Investigative Panel, Comm. on Energy and
Commerce, 114th Cong. (unedited transcript) (Oct. 6, 2016).
68
Interview of [PP Witness #3], before the Select Investigative Panel, Comm. on Energy and Commerce, 114th
Cong. 46 (unedited transcript) (Nov. 1, 2016).
69
Interview of [PP Witness #1], at 223-24.
70
Interview of [PP Witness #1], at 225-27. At that time, [PP Witness #1]s, attorney asked for a break. Upon
returning, [PP Witness #1] stated that if an infant were born with signs of life, she would call an ambulance and
66

22

2. Partial-Birth Abortion Ban Act (PBA)

President George W. Bush signed the Partial-Birth Abortion Ban Act (PBA) on
November 5, 2003.71 In 2007, the Act was upheld by the United States Supreme Court in
Gonzales v. Carhart.72 The PBA prohibits the abortion procedure known as partial-birth
abortion, or intact dilation and extraction, described as when the abortion provider:
(A) deliberately and intentionally vaginally delivers a living fetus
until, in the case of a head-first presentation, the entire fetal head is
outside the body of the mother, or, in the case of breech presentation,
any part of the fetal trunk past the navel is outside the body of the
mother, for the purpose of performing an overt act that the person
knows will kill the partially delivered living fetus; and
(B) performs the overt act, other than completion of delivery, that
kills the partially delivered living fetus. . . .
At least 19 states have laws mirroring the federal PBA.73 Because researchers desire to
obtain intact fetal cadavers and organs, as discussed above, the Panel investigated whether
abortion providers may be using the partial-birth abortion procedure in violation of federal
and/or state law.
D. Laws Related to Public Funding of Fetal Tissue Research and Abortion Providers
1. NIH Grants
On October 4, 2000, the U.S. GAO reported that the National Institutes of Health (NIH)
is the only federal agency under the Subcommittee on Labor, Health and Human Services, and
Education jurisdiction that sponsors research using human fetal tissue.74 NIH spent $76 million
on human fetal tissue research in FY2014, and will spend approximately $76 million in FY2015
and $77 million in FY2016.75 In addition to broader reporting requirements regarding activities
conducted or supported by the NIH, the Director of NIH is required to submit to Congress an
annual report that describes how NIH and its agencies store and track human tissue samples.76
(For a detailed examination of NIH grants, please see Chapter IX.)

give the fetus comfort care until the ambulance arrived if it was viable or looked like [sic] a periviable or would
just give it comfort care and let it expire if the infant were nonviable.
71
18 U.S.C. 1531.
72
550 U.S. 124 (2007).
73
See Guttmacher Institute, Bans on Specific Abortion Methods Used After the First Trimester (Nov. 1, 2016),
https://www.guttmacher.org/state-policy/explore/bans-specific-abortion-methods-used-after-first-trimester.
74
GAO letter to Arlen Specter, Chairman, Subcomm. on Labor, Health and Human Services, and Education,
Committee on Appropriations 2 (Oct. 4, 2000).
75
Kristin Finklea, et al., Cong. Research Serv., R44129, Fetal Tissue Research: Frequently Asked Questions 1 (July
15, 2015) (based on search criteria entered at http://report.nih.gov/categorical_spending.aspx).
76
PL 109-482.

23

2. Federal Funding for Abortion Providers

H. Res. 461 also gave the Panel jurisdiction to review federal funding and support for
abortion providers. Congress has included restrictions on abortion funding in the HHS
appropriations acts since fiscal year (FY) 1977. These restrictions, commonly known as the
Hyde Amendment, prohibit the use of federal and state matching Medicaid funds77 for most
abortions. However, Congress permits abortion funding in specific circumstances that have
changed periodically since enforcement began August 4, 1977, including when a pregnancy
endangers a mothers life or health, and when the pregnancy resulted from rape or incest. In
certain fiscal years, Congress required documentation and reporting to prove that a womans
circumstances fit the exceptions permitting abortion coverage. States may pay for abortions with
state or local funds (not state matching Medicaid funds) allocated for health benefits or
services.78
Other sources of federal funding may be used to pay for abortions; however, they are
generally subject to restrictions mirroring the Hyde Amendment.79 Hyde-like language exists in
the appropriations measures for foreign operations, the District of Columbia, the Treasury, and
the Department of Justice.80 Further, funds available to the Department of Defense (DOD) and
the Indian Health Services (IHS) are limited by codified restrictions.81
While Congress has long limited the use of federal tax dollars to directly pay for
abortions, abortion providers receive significant public funding ostensibly for other purposes.
Sources of funding for reproductive health services include Medicaid (family planning), Title
X of the Public Health Service Act, the Federal Health Center Program, The Ryan White
HIV/AIDS program, the National Breast and Cervical Cancer Early Detection Program, Sexually
Transmitted Diseases Prevention Grants, Title V Maternal and Child health Block Grant, Teen
Pregnancy Prevention Program, and the Social Services Block Grant Program.82 Additionally,
many states and localities provide funding for reproductive health services.
a) Medicaid
Medicaid accounts for 75% of U.S. public expenditures for family planning services
up from 20% in 1980.83 Medicaid reimburses providers for contraceptive items and procedures
and related services, with the federal government paying 90% of the cost (versus 50% to 75% for

Medicaid provides health coverage to millions of Americans, including . . . pregnant women. . . . Medicaid is
administered by states, according to federal requirements. The program is funded jointly by states and the federal
government. Medicaid.gov, overview, https://www.medicaid.gov/medicaid-chip-program-information/medicaidand-chip-program-information.html.
78
See generally FY 2017 Moyer Material, Submitted by the Office of the Assistant Secretary for Financial
Resources, U.S. Depart. of Health and Human Services, Addendum: Abortion-Related Reporting 1-8 (2016).
79
See generally Elayne J. Heisler, et al., Cong. Research Serv., R44130, Federal Support for Reproductive Health
Services: Frequently Asked Questions (Aug. 24, 2016).
80
Id. at 2.
81
Id.; 10 U.S.C. 1093 (DOD) and 25 U.S.C. 1676 (IHS).
82
See generally Federal Support for Reproductive Health Services: Frequently Asked Questions.
83
See, e.g., Guttmacher Institute, Publicly Funded Family Planning Services in the United States,
https://www.guttmacher.org/fact-sheet/publicly-funded-family-planning-services-united-states.
77

24

most other services) and states paying 10%, and with no out-of-pocket costs for beneficiaries.84
Medicaid enrollees are permitted to receive family planning care from qualified providers of
their choice, regardless of whether the providers are in their health plans network. That family
planning provider is then reimbursed by the state or by the plan.85
In FY 2010, federal and state86 public expenditures for family planning services alone
totaled $2.37 billion.87 While not all recipients of this funding perform abortions,88 the nations
largest abortion provider, Planned Parenthood, provides an excellent study of the impact of
public funding on the abortion industry.89 During fiscal year 2015, 43% of Planned Parenthoods
revenue derived from government health services grants & reimbursements, at a price tag of
$553,700,000.90
Further, while abortion providers are not permitted to receive reimbursement for abortion
from Medicaid, former employees of Planned Parenthood have testified that Planned Parenthood
would separate out charges for services and products rendered in connection with abortions, such
as office visits, ultrasounds, Rh factor tests, lab work, general counseling, and abortion aftercare,
and submit those fragmented or unbundled charges as claims for Medicaid reimbursement.91
In fact, the Charlotte Lozier Institute and Alliance Defending Freedom have documented
thatbased on 51 known external audits or other reviews of Planned Parenthood affiliates
financial data and practices, and 61 federal audits of state family planning programs by HHSOIGPlanned Parenthood affiliates have overbilled $132.4 million in Medicaid and other
healthcare funding programs.92 These audit results are troubling, given their limitations in scope,
84

See, e.g., id.; Federal Support for Reproductive Health Services: Frequently Asked Questions.
Federal Support for Reproductive Health Services: Frequently Asked Questions.
86
State funding accounted for 12 percent of the total. Guttmacher Institute, Publicly Funded Family Planning
Services in the United States, https://www.guttmacher.org/fact-sheet/publicly-funded-family-planning-servicesunited-states.
87
Publicly Funded Family Planning Services in the United States.
88
Publicly Funded Family Planning Services in the United States. In 2010, subsidized family planning services
were provided at 8,409 safety-net health centers38% were federally qualified health centers; 29% were health
department clinics; 16% were other clinics; 10% were Planned Parenthood centers; and 8% were hospital clinics.
89
Planned Parenthood is the largest abortion provider in the U.S., performing more than 300,000 abortions per year,
or approximately 1 in 3. Americans United for Life, The New Leviathan: The Mega-Center ReportHow Planned
Parenthood has Become Abortion, Inc. 4 (2015), http://www.aul.org/wp-content/uploads/2015/06/AUL-MegaCenter-Report-06-24-2015.pdf (citing PPH Annual Reports for 2012, 2013, and 2014 at Planned Parenthood of the
Heartland, Publications, http://www.plannedparenthood.org/planned-parenthood-heartland/who-weare/publications).
90
Planned Parenthood Federation of America, Annual Report, 2014-2015, at 32-33,
https://www.plannedparenthood.org/files/2114/5089/0863/2014-2015_PPFA_Annual_Report_.pdf.
91
Americans United for Life, The Planned Parenthood Exhibits: The continuing case for investigating the nations
largest abortion provider Exhibit 17 (2012).
92
Charlotte Lozier Institute and Alliance Defending Freedom, Profit. No Matter What. (Nov. 1, 2016). In addition to
fragmenting and unbundling abortion services in violation of the Hyde Amendment, Planned Parenthood
affiliates were found by audit: Dispensing prescription drugs, including oral contraceptives, without an authorizing
order by a physician or other approved healthcare practitioner; Dispensing prescription drugs, including oral
contraceptives, to patients who have moved or have not been seen by the clinic for more than a year; Billing in
excess of actual acquisition cost or other statutorily approved cost for contraceptive barrier products, oral
contraceptives, and emergency contraceptive-Plan B (i.e., 340B drugs) products; Billing for services that were not
medically necessary, including services for men and for women who were already pregnant, sterilized, or
85

25

detail, and timeframe; in fact, of 57 U.S. Planned Parenthood affiliates, only 19 have been
audited.93
Under federal law, healthcare providers participating in Medicaid are required to return
overpayments within sixty days of identification.94 State Medicaid agencies are also required to
return overpayments and have up to a year to make collections before they are penalized by the
federal government.95
The United States Supreme Court has held that it is permissible for a state to engage in
unequal subsidization of abortion and other medical services to encourage alternative activity
deemed in the public interest.96 However, courts and the executive branch have largely thwarted
efforts to prevent abortion providers from subsidizing abortion and other services with taxpayer
funding.
The Obama Administration has denied or threatened to deny federal Medicaid funding to
states that have attempted to withhold Medicaid reimbursement from abortion providers. Further,
the Seventh and Ninth Circuits have interpreted Medicaids free choice of provider97
provisionguaranteeing Medicaid recipients freedom to choose their family planning
providersas a legal impediment to prohibiting abortion providers from receiving federal
Medicaid funding.98
However, in Planned Parenthood v. Indiana, the Seventh Circuit upheld Indianas
prohibition on abortion providers receiving funding through the federal Disease Intervention
Services agency (DIS), for the diagnosis and monitoring of sexually transmitted diseases. The
Seventh Circuit explained that the key difference between the provision upheld and the provision
struck down was that the DIS program did not have a federal statutory limitation (similar to
Medicaids free choice of provider provision) on how states could determine eligibility.99

postmenopausal; Billing for services that were not actually rendered; Duplicate billing for examinations and
products, including billing products and services already billed as part of a service package, as fee for service;
Incorrectly coding and billing services; Inadequate record-keeping, including lacking documentation to support the
service billed and paid and not signing medical entries; and Failing to pay the bills for which an affiliate had already
been reimbursed with taxpayer funds.
93
See id.
94
SSA Sec. 1128J(d).
95
SSA Sec. 1903(d)(2).
96
Further, the decision not to fund abortion places no governmental obstacle in the path of a woman who chooses to
terminate her pregnancy. See Rust v. Sullivan, 500 U.S. 173, 201 (1991). The Court has repeatedly affirmed the
constitutionality of federal and state restrictions on public funding for abortions. See, e.g., Harris v. McRae, 448
U.S. 297 (1980) (holding that the government may rationally distinguish between abortion and other medical
procedures because no other procedure involves the purposeful termination of a potential life).
97
42 U.S.C. 1396a(a)(23)(B). A state may establish reasonable standards relating to the qualifications of
providers and may exclude healthcare providers under certain circumstances: [i]n addition to any other authority,
a State may exclude an individual or entity . . . for any reason for which the Secretary [of HHS] could exclude the
individual or entity from participation. 42 C.F.R. 431.51(c)(2); 42 U.S.C. 1396a(p)(1)).
98
Planned Parenthood v. Indiana, 699 F.3d 962 (7th Cir. 2012) (invalidating an Indiana law); Planned Parenthood
v. Betlach, 727 F.3d 960 (9th Cir. 2013) (invalidating an Arizona law).
99
Planned Parenthood v. Indiana, 699 F.3d 962, 985 (7th Circ. 2012).

26

Legislative history demonstrates that states should have the power to exclude providers
for any reason/basis under its state laws: This provision is not intended to preclude a State from
establishing, under State law, any other bases for excluding individuals or entities from its
Medicaid program.100 Also, the First Circuit held that the language of Medicaids exclusion
provision was intended to permit a state to exclude an entity from its Medicaid program for any
reason established by state law.101
b) Title X
Title X is the only federal grant program dedicated solely to providing family planning
and related preventive care and is viewed as setting the standard for publicly funded family
planning services. Priority is given to low-income families. Title X provides that none of the
funds appropriated shall be used in programs where abortion is a method of family
planning.102 Public and private entities may obtain grants.
Ten percent of U.S. public expenditures for family planning client services are through
Title X.103 This is a 71% drop since 1980. Title X funding is valued because it provides more
flexibility than Medicaid. The grants are used to maintain a network of family planning
Centers. The Reagan administrations strict regulations on Title X funding, designed to ensure
the funds were not being used to subsidize abortion, were upheld by the Supreme Court in Rust
v. Sullivan;104 however, they are not in effect today.
Since 2011, numerous states have enacted laws requiring subrecipients of Title X funds
to provide comprehensive healthcare to patients and/or refrain from performing abortions. In
response, the federal government is actively circumventing the Title X prioritization laws in at
least eight states by directly contracting with private entities such as Planned Parenthood.
Further, on Sept. 9, 2016, HHS issued a proposed rule stating that [n]o recipient making
sub awards for the provision of services as part of its Title X project may prohibit an entity from
participating for reasons unrelated to its ability to provide services effectively.105 In the
proposed rule background, HHS states that 13 states have placed restrictions on or eliminated
sub awards with specific types of providers. . . .106

100

S. Rep. No. 100-109, at 20 (1987).

First Medical Health Plan v. Vega-Ramos, 479 F.3d 46, 53 (1st Cir. 2007) (emphasis in original).
102
42 U.S.C. 300a-6.
103
Publicly Funded Family Planning Services in the United States. Other family planning funding: 75% - Medicaid;
12% - state-only sources; 3% - other federal sources.
104
500 U.S. 173 (1991).
105
Compliance with Title X Requirements by Project Recipients in Selecting Subrecipients, 81 Fed. Reg. 173
(proposed Sept. 7, 2016) (to be codified at 42 C.F.R. pt. 59).
106
Id.
101

27

III. Panel Hearings

The Panel held two public hearings to examine critical issues within its jurisdiction. In
the first hearing on Bioethics and Fetal Tissue, the Panel noted that there have been several
government-sponsored discussions on bioethics, but none directly on the transfer of fetal tissue
since the 1980s. The hearing revealed substantial concern about the consent process for the
donation of human fetal tissue used by abortion clinics and procurement businesses. Evidence
revealed that self-interested staff, whose pay depends on the numbers of specimens donated,
were assigned to obtain consent from patients. Additional evidence showed that tissue
technicians and the abortion clinics violated the patients privacy rights under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). Still other evidence revealed that
some middleman companies misrepresented that the consent forms and methods of tissue
harvesting comply with federal regulations regarding Institutional Review Boards (IRBs). This
evidence points toward conduct focused on profit and not on patient welfare.
The Panels next hearing, The Pricing of Fetal Tissue, sought the judgment of seasoned
federal prosecutors to compare the federal statute prohibiting profit from fetal tissue sales with
the first tranche of materials from the investigation. Two former U.S. attorneys and a senior
federal litigator agreed that based on the materials presented to them, they would open a case
against a middleman company. The former prosecutors also suggested that accounting and bank
records would be critical to understanding whether there was a violation of federal law. Minority
witnesses agreed with this approach and urged the Panel to obtain such records.
A. Bioethics and Fetal Tissue
On March 2, 2016, the Panel held a hearing entitled Bioethics and Fetal Tissue. The
hearing focused on ethical issues raised as a result of information recently made public about
fetal tissue donations, transfer of fetal tissue, and use of fetal tissue by research institutions. The
witnesses helped the Panel understand the ethical questions, both on theoretical and practical
levels, which arise when fetal tissue is acquired and used in biomedical research.
Bioethics has its origins as a field of academic inquiry in the early 1960s due to
extraordinary advances and development in American medical knowledge and practice. Organ
transplantation, kidney dialysis, respirators, and intensive care units made possible medical
procedures never before imagined. The first heart transplant raised ethical questions relating to
the sources of organs for transplantation, how they would be allocated, and payment for these
procedures.
Public debates took place and, in response, scholars and academics began to think and
write about these issues, and scholars began to fuse theoretical ethics with applied or practical
ethics. Since that time, continuing biomedical advances have presented bioethical questions that
need to be confronted and addressed by societies.
Todays headlines are full of announcements and predictions that a few short years ago
were the subject of speculative fiction. Organ reconstitution, three-parent children, personalized
medicine, organ cloning, chimeras, gene therapy and editing, and bioinformatics are all recent
28

subjects discussed by professionals and the public. The current director of the National Institutes
of Health has proposed compiling DNA information to help inform medical decisions and
therapies. While these therapies further knowledge of biomedical and scientific information
related to medical treatments and therapies, they also present broader ethical questions.
Paige Comstock Cunningham, Executive Director for The Center for Bioethics & Human
Dignity, told the Panel that you cannot take a life and then give away the body. Participants in
elective abortion, including the mother, are morally disqualified from consenting to donating the
body, organs, or tissue of the now dead fetus for research purposes.107
Dr. Patrick Lee, a professor at the Center for Bioethics at Franciscan University of
Steubenville, spoke of his concern that governmental funding of abortion providers and the use
of fetal tissue from elective abortions involve profound dehumanization of unborn human beings
and are grave injustices.108
During the hearing, Majority and Minority Members and witnesses discussed current
bioethical questions regarding the use of fetal tissue in scientific research. One concern raised by
the Minority Members of the Panel and the Minority witnesses was that stopping the use of fetal
tissue in scientific research, such as developing a cure for the Zika virus, would delay the finding
of a cure. Rep. Jan Schakowsky (IL-9) asked Dr. Lawrence Goldstein, a minority witness,
Would not having fetal tissue as a resource in this study potentially delay finding a cure? Dr.
Goldstein replied, It would absolutely delay it.109
However, later in the hearing in an exchange with Dr. Goldstein, Rep. Andy Harris (MD1), who is also a physician, emphasized that sometimes delays occur in order to ensure that
research, especially research conducted on human subjects, is done ethically and safely.
Addressing Dr. Goldstein, Rep. Harris stated, [Y]ou have suggested that anything that slows
this process down is a bad thing. You kind of suggested that. . . . How long does it take your IRB
to approve, normally? Mine took months. I know exactly why you are laughing. It can take
months or even a year, cant it?110 Rep. Harris summarized their discussion by stating that the
United States has already decided that it is all right to slow down life-saving research when it
involves humans for ethical reasons because we have a national policy that you have to have an
IRB.111 Furthermore, the idea that not having access to fetal tissue would delay the discovery of
a cure is mere speculation, especially since fresh fetal tissue has not been successful in curing
diseases. Dr. Goldstein conceded Rep. Harris point.
Also during the hearing, Members of the Panel expressed their deep concern regarding
the issue of consent and minors. Rep. Mia Love (UT-4) stated: So imagine [a] 14-year-old
going into a clinic to undergo a very invasive procedure without someone there that she trusts to
walk her through, to make sure that she is not being taken advantage of, to make sure that she is
making the right decision.112 Rep. Love asked, How can anyone be sure that a minor, under
107

Bioethics and Fetal Tissue, at 24 (Mar. 2, 2016) (unedited transcript).

Id. at 98.
109
Id. at 120.
110
Id. at 138.
111
Id. at 139.
112
Id. at 86-87.
108

29

difficult circumstances, fully understand[s] the long-term repercussions behind [her] decision
when the current law wouldnt even allow that minor to get behind the wheel of a vehicle?113
Dr. Gerald Kevin Donovan, a witness at the hearing, agreed that this presented a troubling
problem.114
Dr. Kathleen Schmainda, a Professor at the Medical College of Wisconsin, told the Panel
that the repeated assurances that proper ethical guidelines are in place to avoid the connection
between abortion and subsequent research are entirely inadequate.115
Members and witnesses came to a bipartisan agreement on several points:

No one should profit from the sale of fetal tissue.116

Inappropriate to get pregnant in order to donate fetal tissue for

research.117

Common
Ground

A form used by an abortion clinic to obtain a womans consent to donate

fetal tissue contained inappropriate statements and should not have made
it past an IRB.118
No cures have been found that require fetal tissue.119
Fetal tissue should not be used for cosmetics or taste testing.120

It is a moral decision for a woman to decide whether to make the fetal

tissue donation.121

113

Id.
Id.
115
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong. 105 (Mar. 2, 2016) (unedited transcript).
116
Id. at 161.
117
Id. at 37-38.
118
Id. at 149.
119
Id.
120
Id. at 37, 89, 136-37, 163 (Ms. Alta Charo, a minority witness, stated, Well, using any tissue, fetal or adult, I
find the cosmetic uses in Hollywood sometimes to be so frivolous, I would be perfectly happy to see us abandon
them.).
121
Id. at 140.
114

30

Amazing scientific and biomedical advances are continuously being discovered and
developed. Congress, research institutions, and the medical community must continue to work
together to promote medical advancements while simultaneously ensuring that laws and
regulations on ethics remain up to date. Whenever biomedical research is conducted on human
subjects, the work must be ethical and preserve the dignity of the human beings who made these
advancements possible.
B. The Pricing of Fetal Tissue
On April 20, 2016, the Panel held a hearing on The Pricing of Fetal Tissue. During the
hearing, the Panel examined documents revealing that abortion clinics and Tissue Procurement
Businesses (TPBs) may have violated federal law by the payments they collected from the sale
of fetal tissue. At the core of the Panels investigation is a federal statute, 42 U.S.C. 289g2, which prohibits the transfer of any human fetal tissue for valuable consideration. The statute
states that reasonable costs include transportation, implantation, processing, preservation,
quality control, and storagenone of which it appears the abortion clinics did. Documents also
show that payments made by the customer to the procurement business appear to exceed the
costs incurred on the procurement business by a factor of 300 to 400 percent.122
Witnesses at the hearing were presented with a sample of the accounting records from
StemExpress and several abortion clinics. The witnesses for the hearing included three former
prosecutors who all agreed that the documents made the case that 42 USC 289g-2 may have
been violated and that further investigation was warranted. All witnesses at the hearing agreed
that the Panel should review all bank and accounting records in order to gain a complete
understanding.
When asked by Rep. Joe Pitts (PA-16) what communications or information should be
sought to learn whether the intent of the procurement business and the abortion clinic was to
profit from the sale of fetal tissue, former U.S. Attorney Kenneth Sukhia said, I would also want
to know what communications occurred between other communications, email and so forth,
back and forth between those people. We would seek those items as well, and of course the
accounting records.123
Brian Lennon told the Panel that a competent and ethical federal prosecutor could
establish probable cause that both the abortion clinics and the procurement businesses [that the
Panel was investigating] violated the statute, aided and abetted one another in violating the
statute, and likely conspired together to violate the statute. Lennon went on to say in my
opinion, there is proof without a reasonable doubt.124 He told the Panel that a forensic
accounting would be essential to breaking down the company's financials.125

122

See generally The Pricing of Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy
and Commerce, 114th Cong. (Apr. 20, 2016) (unedited transcript).
123
Id. at 147.
124
Id. at 52-53.
125
Id. at 56-57.

31

Fay Clayton, a lead Democrat witness, said shed have them [StemExpress] come in, put
them under oath . . . and ask them how did you come up with this charge?126 Clayton said she
would ask them, in each particular case, what aspect of the actual costs does a particular clinic
incur? For example, does the clinic provide space? Does the clinic, as we have seen in your
charts, provide the blood draws which requires a technician, perhaps a nurse, materials? Does the
clinic have to do paperwork? And, if so, how much? And, therefore, how much of the actual
reasonable cost is incurred by the clinic itself as opposed to by the procurement business?127
Former U.S. Attorney Michael Norton told the Panel that he would get forensic
accounting.128 I would get all of the financial records. I would get the profit and loss
statements, the income and expense statements, and I would get people under oath before a grand
jury,129 Norton said.
Catherine Glenn Foster told the Panel that there were two things she would specifically
seek among other documents:
First of all, financial records. That is something that must be brought
to light. And, second, women of every generation are unique human
beings who can speak for themselves, but the baby body parts
profiteers have created a market in which their profits rise if they
pressure and coerce women into signing donation consent forms.130
Based on the consensus reached by witnesses at the hearing, the Panel has worked to acquire and
further investigate the details of accounting records, accounts payable, and cash transfers of
abortion businesses, fetal tissue procurement organizations, and related entities to determine
whether or not someone made a profit.

126

Id. at 144.
Id. at 145.
128
Id. at 146.
129
Id.
130
Id.
127

32

IV. Criminal and Regulatory Referrals

15 Criminal & Regulatory Referrals
The Select Investigative Panel has made numerous criminal and regulatory referrals and
investigations are underway around the nation.
1) The Panel discovered that the University of New Mexico may have been violating its states
Anatomical Gift Act by receiving tissue from a late-term abortion clinic (Southwestern Womens
Options). Referred to the Attorney General of New Mexico.
2 & 3) The Panel conducted a forensic accounting analysis of StemExpress limited production
and determined that it may have been profiting from the sale of baby body parts. Referral sent to
El Dorado, California, District Attorney, and the U.S. Department of Justice.
4) The Panel learned that StemExpress and certain abortion clinics may have violated the HIPAA
privacy rights of vulnerable women for the sole purpose of increasing the harvesting of fetal
tissue to make money. Referred to the U.S. Department of Health and Human Services.
5) The Panel uncovered evidence showing that StemExpress may have violated federal
regulations governing Institutional Review Boards (IRBs). Referred to the U.S. Department of
Health and Human Services.
6) The Panel discovered that an abortion clinic in Arkansas may have violated the law when it
sent tissue to StemExpress. Referred to the Attorney General of Arkansas.
7) The Panel discovered that DV Biologics, another tissue procurement company, may have been
profiting from the sale of fetal tissue, and was not collecting California sales tax from purchasers
of the baby body parts. The Orange County District Attorney has filed a lawsuit and the Panel
sent a supplemental referral.
8) The Panel learned that Planned Parenthood Gulf Coast may have violated both Texas Law and
U.S. Law when it sold fetal tissue to the University of Texas. Referred to the Texas Attorney
General.
9) The Panel learned that Advanced Bioscience Resources appeared to have made a profit when
it sold tissue to various universities. Referred to the District Attorney for Riverside County,
California.
10) The Panel discovered that an abortion clinic in Florida, at least in part through its
relationship with StemExpress, may have violated various provisions of federal and state law by
profiting from the sale of fetal tissue. Referred to the Attorney General of Florida.
11 & 12) The Panel has uncovered evidence from former employees and a patient of a late-term
abortionist in Texas alleging numerous violations of federal and state law at one or more of the

33

practitioners clinics. The allegations include eyewitness accounts of the doctor killing infants
who show signs of life both when partially outside the birth canal, in violation of the PartialBirth Abortion Ban Act, and after they are completely outside the birth canal, in violation of the
Born-Alive Infants Protection Act and Texas murder statutes. Referred to the Texas Attorney
General, and the U.S. Department of Justice.
13) The Panel made a supplemental referral to the Attorney General of New Mexico based on
information produced in document productions by the University of New Mexico (UNM) and
Southwestern Womens Options (SWWO), deposition testimony by Doctor #5, and a complaint
and affidavit with supporting documents submitted by a former patient at SWWO. It details the
alleged failure of SWWO and UNM to provide informed consent to women prior to using tissue
from abortions for research at the university.
14) The Panel has discovered information that StemExpress may have destroyed documents that
were the subject of congressional inquiries, document request letters, and subpoenas, in violation
of 18 U.S.C. 1519. Referred to the U.S. Department of Justice.
15) Over the course of its investigation, the Panel has uncovered documents and received
testimony from confidential informants indicating that several entities, including four Planned
Parenthood clinics and Novogenix, may have violated federal law, specifically Title 42 U.S.C.
289g-2, which forbids the transfer of fetal tissue for valuable consideration. Referred to the U.S.
Department of Justice.

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ONE HUNDRED FOURTEENTH CONGRESS

(!Congre55 of tbe Wniteb

~tate5
J!)ouge of l\epregentatibeg

COMMITTEE ON ENERGY AND COMMERCE

2125 R AYBURN HOU SE OFFICE BUILDING
WASHIN GTON, DC 20515-6115
Majorit y (202) 225- 2927
Minority (202) 225-3641

December 7, 2016
VIA EMAIL
The Honorable Ken Paxton
Office of the Attorney General
300 W. 15 th Street
Austin, TX 78711-2548
Dear Attorney General Paxton:
On October 7,2015, the U.S. House of Representatives passed H. Res. 461, which created the
Select Investigative Panel (the "Panel") and empowered it to conduct a full and complete
investigation regarding the medical practices of second- and third-trimester abortion providers
and the practices of entities that procure and transfer fetal tissue. This includes investigation of
partial-birth abortion and the standard of care for infants who survive the abortion procedure.
Over the course of our investigation, we have collected statements and video from former
who allege numerous violations oflaw at one
employees and a patient of
or more of his clinics, describing the practitioner as conducting himself with depraved
indifference to infant life and committing acts of murder.
Allegations Against
is an aboliion provider who has operated at three locations in Houston, Texas,
including the Aaron Women's Clinic ("Aaron"), the Texas Ambulatory Surgery Center, and the
Women's Pavilion; and at the Northpark Medical Group in Dallas. Several former employees
who worked with him at one or more of the HOllston locations have come forward alleging
numerous violations oflaw.
According to several of his employees, including Employee #1 and Employee #2, who were
medical assistants, and Employee #3, who assisted with administrative tasks, numerous patients
of
delivered infants alive prior to their demise, which the doctor himselfbrought
about. Specifically, Employee #1, who assisted the doctor in the operating room at Aaron,
would perform
estimated that "[dJuring a typical week with a full patient load, ...

104

abortions at 20 or more weeks gestation, i.e., later in the second trimester or in the third
trimester, on approximately 40 patients.1 Of that number, Employee #1 asserted:
approximately three or four infants would show signs of life. This typically
happened when infants were extracted from the cervix in a breech position. At
times, the infant would slide completely out because of the extent of the dilation
caused by the laminaria administered to patients. In all such cases,
would terminate their lives. The signs of life they exhibited would include
movement of the stomach as the infant breathed or movement of the toes or
fingers.2
would terminate the lives of these infants, Employee #1 further alleges based on
those incidents she witnessed, by any of several methods, including the following:
snipping the infants spinal cord with scissors; cutting the neck with Sopher
forceps or similar instruments; twisting the infants head; using forceps, other
instruments, or his finger to crush the soft spot of the infants head, or crushing
it by the same means through its stomach; or inserting his finger down its throat.
If the infants cranium was coming out first, he would usually use his index finger
to puncture its head, but if it was coming out feet first, he would instead insert an
instrument in the back of the infants head.3
Several of the same allegations were also made by Employee #2.4
Employee #3 was not in the treatment rooms when abortions took place, but she alleges she
learned from her coworkers of numerous infants whose lives were terminated by
after showing signs of life following partial or full extraction from the uterus.5 On one occasion,
she stated that she learned from a coworker of an infant killed by the doctor after surviving an
abortion; as he was preparing to put it into a bag for disposal, she maintained, the infant had
opened up his eyes and grabbed his hand.6
Employee #1 stated that [o]f the three to four infants terminated in a typical week by
while showing signs of life, on average, approximately one or two would be put to death after
they had left the birth canal entirely. The balance were terminated while they were partially out
of the birth canal.7 Employee #1 added that she never observed
make an attempt to
keep alive or resuscitate any infant who showed any signs of life or to direct anyone else to do
so, an observation consistent with Employee #3s understanding.8
Affidavit of Employee #1, Dec. 5, 2016, 1-2, attachment 1 [hereinafter Employee #1 Aff.].
Id. 3.
3
Id. 4.
4
See Redacted videosee key, attachment 2 [hereinafter Redacted video] (Sometimes he would go through the
stomach as well. . . . He would like force it [the instrument] through the stomach . . . and he twists it.) (he would
put, like, his finger . . . through the throat) (statements of Employee #2).
5
Affidavit of Employee #3, Dec. 6, 2016, 2, attachment 3 [hereinafter Employee #3 Aff.].
6
Redacted video.
7
Employee #1 Aff. 5.
8
Id. 5; Employee #3 Aff. 2.
1
2

105

Employee #1 also alleged that

performed numerous abortions during the third
trimester in cases that did not involve any serious threats to the mothers or the infants health.9
Employee #2 asserted, As long as the patients had the cash, he was going to do it past the 25
weeks.10 Four photographs identified by Employee #1 and Employee #3 as taken in the
sterilization room of the Womens Pavilion in 2012 depict the remains of infants clearly in their
third trimester when they were allegedly terminated by
.11 According to Employee #1,
the tears in the neck line visible in the photos are inconsistent with terminations done while
the infant[s were] entirely inside the uterus.12 Thus, besides being late-term abortions, they were
likely either partial-birth abortions or homicides committed after full delivery.
Employee #1 and two other employees at the clinic, Employee #3 and Employee #4, additionally
allege that the doctor regularly falsified sonogram results to misrepresent the gestational age of
the fetus. Some sonograms, they maintain, would be falsified to overstate the gestational age of
the fetus in order to overbill customers.13
In other cases, according to Employee #1 and Employee #3, sonograms would be falsified to
conceal the advanced gestational age of the fetus beyond the legal limit in Texas.14 Employee #1
claimed:
I have witnessed this happen in cases involving fetuses as old as 28 weeks.
would typically tell his ultrasound technician in cases involving fetuses
beyond a certain gestational age to allow him to perform the ultrasound himself;
he would then bring the patient an ultrasound picture showing another fetus at the
gestational age he was misrepresenting to the patient.15
An affidavit from a patient attached hereto alleges another specific case of manipulation: Patient
#1, a woman who obtained an abortion in 2002 at 24 to 25 weeks gestation, worried that I
was too far along. The girl doing my ultrasound told me that ultrasounds can be manipulated.
The clinic determined me to be 23 weeks.16 On two occasions that I witnessed, Employee #1
also alleges that
failed to inform a patient she was pregnant with twins.17
According to Employee #1 and Employee #3, the doctor would regularly make use of pre-drawn
medicine, including Demerol and Nubain, without properly logging or storing it. They added:
This included improperly storing medicine in a food refrigerator. On one
occasion,
concealed these practices during an inspection from the

Employee #1 Aff. 6.
Redacted video.
11
Employee #1 Aff. 6; Employee #3 Aff. 3. According to Employee #3, the photos were taken July 26, 2012. Id.
12
Employee #1 Aff. 6.
13
Id. 7; Employee #3 Aff. 4; Statement of Employee #4, Nov. 23, 2012, attachment 4, at 1.
14
Employee #1 Aff. 7; Employee #3 Aff. 4.
15
Employee #1 Aff. 7.
16
Affidavit of Patient #1, June 17, 2013, attachment 5.
17
Employee #1 Aff. 8.
9

10

106

Harris County Public Health office by having a nurse put pre-drawn medicine in
basins, which she hid in the trunk of her car while the inspector was present.18
Employee #1 and Employee #3 also allege the doctor failed to keep a registered nurse on site in
the recovery room at Aaron, which left unqualified workers to draw and administer drugs.19
Employee #1 added that
concealed this deficiency from authorities by hir[ing] a
nurse from a temp agency for a few days at a time when a government inspection was
scheduled.20 Employee #1 recorded examples of storage, recordkeeping, and personnel
violations in an undercover video from 2011 attached hereto.21
Additionally, according to Employee #1:
would regularly fail to observe proper sterilization procedures. This
included the doctors habitual reuse of a bottle of Betadine, which is used for
cleaning prior to the procedure, that was not cleaned or stored, and which he
handled with his gloved hand for patient after patient when going inside the
cervix. Additionally, after removing instruments such as Hawkins-Amblers
dilators and Bierer and Sopher forceps from sterile packages, he would place
unused instruments back in the sterile package to use on other patients. He often
would do so wearing gloves that he did not change between seeing one patient
and another, or between trips to the restroom. . . . Instruments in
s
clinic were not regularly soaked in sterilizing solutions as they needed to be for
specified periods of time in order to be sterile. The exception to this occurred
prior to government inspections. The vast majority of the doctors assistants in the
sterilization room were uninformed on proper methods of sterilization. In order to
reduce his costs,
also habitually disposed of biohazardous waste in
standard garbage bags instead of sterile bags required for such waste.22
The same failure with respect to sterilization was also alleged by Employee #2, Employee #3, and
Employee #4.23
Violations of Applicable Laws
Federal law makes clear that infants that are born, regardless of whether naturally or by
extraction during an abortion, are entitled to the same protections given to every other person.
Under the Born-Alive Infants Protection Act of 2002, every infant member of the species homo
sapiens who is born alive at any stage of development is considered a person.24 This is so
Id. Aff. 9; Employee #3 Aff. 5. See also Redacted video.
Employee #1 Aff. 10; Employee #3 Aff. 6.
20
Employee #1 Aff. 10. For additional information regarding the deficiencies in
s nursing staff and
other allegations regarding possible violations at his clinics, see Statement of Employee #1 in support of Complaint
against
D.O., Apr. 26, 2010, attachment 6.
21
Aaron Womens Clinic video by Employee #1, attachment 7.
22
Employee #1 Aff. 11-12. See also Statement of Employee #1 in support of Complaint against
D.O., Apr. 26, 2010, attachment 6, at 3.
23
Redacted video; Statement of Employee #4, Nov. 23, 2012, attachment 4, at 1.
24
1 U.S.C. 8(a).
18
19

107

whenever an infant undergoes "complete expulsion or extraction from his or her mother" and
"has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles,
regardless of whether the umbilical cord has been cut, and regardless of whether the expulsion or
extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion .,,25
The Partial-Birth Abortion Ban Act of2003 makes clear that such protections apply even if the
infant is onl y partially extracted from the mother's body at the time its life is ended. Specifically,
a prohibited "partial-birth abortion" occurs when a person knowingly commits "an overt act ...
that kills the pmiially delivered li ving fetus" after the fetus is partially delivered with its entire
head "outside the body of the mother, or, in the case of breech presentation, any part of the fetal
trunk past the navel.,,26 The only exceptions occur when such a procedure "is necessary to save
the life ofa mother whose life is endangered" by certain categories of physical conditions 27
Violations of the 2003 act are punishable by fines, imprisonment for up to two years, or both.28
The foregoing allegations advance numerous federal violations against
of the
Partial-Birth Abortion Ban Act in those cases involving his terminations of partially delivered
infants and of the Born-Alive Infants Protection Act in those cases where the infants have
completely exited a mother' s body. In at least the latter cases, they also amount to allegations
that
violated Texas' criminal homicide statutes. First, the allegations constitute
murder, defined by the Texas Penal Code as "intentionally or knowingly caus[ing] the death of
an individual.,,29 Second, the allegations against
constitute capital murder under
Texas law in both ofthe following circumstances, either one of which is sufficient to establish
that offense:

"the person murders more than one person ... during different criminal transactions but
the murders are committed pursuant to the same scheme or course of conduct;,,30 and

" the person murders an individual under 10 years of age .. .. "31

The murders alleged against

occurred on a repeated basis, and all occurred pursuant
to his course of conduct as a provider of abortion who was alleged to have systematically killed
any infant aborted while showing signs of life. The second circumstance is independently
established by the obvious fact that every alleged victim was under 10 years of age.
's alleged conduct would also violate the gestational age limit established under
Texas law. Former employees of the doctor allege he performed abortions as late as the third
trimester. 32 Third trimester abortions are prohibited with narrow exceptions, inapplicable
according to the allegations in the instant case, where "the abortion is necessary to prevent the
death of the woman," the "unborn child has a severe, irreversible brain impairment; or ... the
woman is diagnosed with a significant likelihood of suffering imminent severe, irreversible brain
1 U.S.C. 8(b).
18 U.S.C. 1531(b)(1).
21 18 U.S.C. 1531(a).
28 Id.
29 Tex. Penal Code 19.02(b)(1).
30 Tex. Penal Code 19.03(a)(7).
31 Tex. Penal Code 19.03(a)(8).
32 Emp/oyee #1 Aff. ,, 6; Emp/oyee #3 Aff. "2.
25

26

5
108

damage or .. . paralysis.,,33 Since H.B. 2 became effective October 29,20 13, abortions
additionally have been prohibited when "the probable post-fertilization age of the unborn child is
20 or more weeks.,,34
's abortion practice is believed to continue to the present day, so
it merits investigation whether he has violated both gestational limits.
The allegations that
regularly falsified sonogram results to misrepresent the
gestational age of the fetus also potentially implicate both state and federal law. Regardless of
whether the patient or another entity is responsible for payment, Texas law clearly prohibits
fraudulent billing. Such conduct would constitute a form oftheft35 in addi tion to violating Texas'
prohibition on insurance fraud. 36 In those cases in which patients were eligible for Medicaid
coverage, such allegations would implicate numerous federal criminal prohibitions on false
statements to federal agencies 3? and on false statements involving health care benefit programs,38
as well as the prohibitions on health care fraud. 39 Such conduct would also violate the federal
False Claims Act40 and Texas' prohibition of Medicaid fraud. 41
Other provisions of Texas law prohibit additional conduct alleged above on the part of
, including the following:

Mi srepresentation of sonogram readings: In addition to violating the above-cited statutes

prohibiting fraud, tampering and alteling records containing patient data is prohibited
under 25 Tex. Admin. Code 135.9(d).

Failure to properly store and log medication: The obligation to maintain and provide
drugs safely and to properly log their use is set forth in detail under 22 Tex. Admin. Code
29 1.76 and made applicable to ambulatory surgical centers under 25 Tex. Admin. Code
135. 12.

Lack of adequate medical staff: 25 Tex. Admin. Code 135.7 requires health care
practitioners to meet numerous requirements that include necessary and appropriate
training and to adhere to state law and "the standards and ethics of their professions." 25

Tex. Occ. Code 164.052(a)(18). The Texas Health and Safety Code contains an additional prohibition of thirdtrimester abortions, under which such abortions are pennitted only when they are "necessary to prevent the death or
a substantial risk of serious impairment to the physical or mental health of the woman" or "the fetus has a severe and
irreversible abnormality," in which case the physician is required to submit a written certification of the applicable
conditions to the Department of State Health Services. Tex. Health & Safety Code 170.002(b)-(c).
14 Tex. Health & Safety Code 171.044, 171.045 . Exceptions app ly when abortion is deemed necessary "to averl
the woman's death or a serious risk of substantial and irreversible physical impairment of a major bodily function,
other than a psychological condition." Tex. Health & Safety Code 17 1.046. Note that these provisions of H.B . 2
were not challenged in Whole Woman's Health v. Hellerstedt, 136 S. Ct. 2292 (20 16).
35 Tex. Penal Code 31.03.
36 Tex. Penal Code 35.02.
37 18 U.S.C. 1001; 18 U.S.C. 287. An accompanying prohibition on conspiracy in connection with such claims is
established by 18 U.S.C. 286.
38 18 U.S.C. 1035.
39 18 U.S.C. 1347; 42 U.S.C. 1320a-7b(a). If fraud is proven to have bee n carried out by utilizing either the mails
or other applicable interstate carriers or communications, the federal mail and wire fraud statutes would also be
implicated. See 18 V.S.c. 1341 , 1343.
40 31 U.S.C. 3729(a)(1).
41 Tex. Penal Code 35A.02.

33

6
109

Tex. Admin. Code 135.15 specifies requirements for an organized nursing service
under the direction of a qualified registered nurse and other personnel that must be
present at the medical facility.
s fonner employees' allegations amount to a
violation ofthese sections. Additional investigation is warranted into whether clinic
practices were in compliance with other requirements for adequate medical staff,
including 25 Tex. Admin. Code 135.10, which addresses additional facility
requirements, and 25 Tex. Admin. Code 135.11, which addresses anesthesia and
surgical services.

Failure to observe proper sterilization procedures and disposal practices : 25 Tex. Admin.
Code 135.1 1(b)(12) requires the development, implementation, and enforcement of
such procedures, and 25 Tex. Admin. Code 135.52(d)(14) requires sterilizing facilities
to be included and properly maintained and utilized.

Fraudulent concealment fi'om government authorities of the foregoing alleged violations:

The fabrication, alteration, and in appl icable cases concealment involved in these
allegations entail conduct proscribed by Tex. Penal Code 37.09. It also subverts the
state's right to inspect faciliti es containing controlled substances pursuant to Tex. Health
& Safety Code 481.181.

was previously referred to the Distlict Attorney of Harris County, but the
investigation into the matter was deficient. In light of the gravity of the allegations outlined
above and the supporting documentation, I urge your office to conduct a thorough investigation
into whether
violated federal and state law, and, if you agree that such violations
occurred, to take all appropriate action. If you have any questions about this request, please
contact Frank Scaturro, at (202) 225 -2927, [email protected].
Sincerely yours,

Ma
lackburn
Chair
Select Investigative Panel
Attachment(s)

cc:

The Honorable Jan Schakowsky

Ranking Member
Select Investigative Panel

7
110

ONE HUNDRED FOURTEENTH CONGRESS

((ongre55 of tbe Wnfteb

~OUlH~

~tate5
of l\eprcsentatibes

COMMITTEE ON ENERGY AND COMMERCE

2125 R AYBUR N H OU SE OFFI CE BUILDI NG
WAS HIN GTON, DC 20515-6115
Majority (202) 225-2927
Minority (202) 225-364 1

December 7,2016

VIA EMAIL AND FIRST CLASS MAIL

The Honorable Loretta Lynch
Attorney General
c/o Office of Legislative Affairs
U.S. Department of Justice
950 Pennsylvania Ave., NW
Washington, DC 20530
Dear Attorney General Lynch:
On October 7,2015, the U.S. House of Representatives passed H. Res. 461, which created the
Select Investigative Panel (the "Panel") and empowered it to conduct a full and complete
investigation regarding the medical practices of second- and third-trimester abortion providers
and the practices of entities that procure and transfer fetal tissue. This includes investigation of
partial-birth abortion and the standard of care for infants who survive the abortion procedure.
Over the course of our investigation, we have collected statements and video from former
who allege numerous violations oflaw at one
employees and a patient of
or more of his clinics, describing the practitioner as conducting himself with depraved
indifference to infant life and committing acts of murder.

Allegations Against
is an abortion provider who has operated at three locations in Houston, Texas,
including the Aaron Women's Clinic ("Aaron"), the Texas Ambulatory Surgery Center, and the
Women's Pavilion; and at the Northpark Medical Group in Dallas. Several former employees
who worked with him at one or more of the Houston locations have come forward alleging
numerous violations oflaw.
According to several of his employees, including Employee #1 and Employee #2, who were
medical assistants, and Employee #3, who assisted with administrative tasks, numerous patients
of
delivered infants alive prior to their demise, which the doctor himself brought
about. Specifically, Employee #1, who assisted the doctor in the operating room at Aaron,
would perform
estimated that "[ d]uring a typical week with a full patient load, ...

111

abortions at 20 or more weeks gestation, i.e., later in the second trimester or in the third
trimester, on approximately 40 patients.1 Of that number, Employee #1 asserted:
approximately three or four infants would show signs of life. This typically
happened when infants were extracted from the cervix in a breech position. At
times, the infant would slide completely out because of the extent of the dilation
caused by the laminaria administered to patients. In all such cases,
would terminate their lives. The signs of life they exhibited would include
movement of the stomach as the infant breathed or movement of the toes or
fingers.2
would terminate the lives of these infants, Employee #1 further alleges based on
those incidents she witnessed, by any of several methods, including the following:
snipping the infants spinal cord with scissors; cutting the neck with Sopher
forceps or similar instruments; twisting the infants head; using forceps, other
instruments, or his finger to crush the soft spot of the infants head, or crushing
it by the same means through its stomach; or inserting his finger down its throat.
If the infants cranium was coming out first, he would usually use his index finger
to puncture its head, but if it was coming out feet first, he would instead insert an
instrument in the back of the infants head.3
Several of the same allegations were also made by Employee #2.4
Employee #3 was not in the treatment rooms when abortions took place, but she alleges she
learned from her coworkers of numerous infants whose lives were terminated by
after showing signs of life following partial or full extraction from the uterus.5 On one occasion,
she stated that she learned from a coworker of an infant killed by the doctor after surviving an
abortion; as he was preparing to put it into a bag for disposal, she maintained, the infant had
opened up his eyes and grabbed his hand.6
Employee #1 stated that [o]f the three to four infants terminated in a typical week by
while showing signs of life, on average, approximately one or two would be put to death after
they had left the birth canal entirely. The balance were terminated while they were partially out
of the birth canal.7 Employee #1 added that she never observed
make an attempt to
keep alive or resuscitate any infant who showed any signs of life or to direct anyone else to do
so, an observation consistent with Employee #3s understanding.8
Affidavit of Employee #1, Dec. 5, 2016, 1-2, attachment 1 [hereinafter Employee #1 Aff.].
Id. 3.
3
Id. 4.
4
See Redacted videosee key, attachment 2 [hereinafter Redacted video] (Sometimes he would go through the
stomach as well. . . . He would like force it [the instrument] through the stomach . . . and he twists it.) (he would
put, like, his finger . . . through the throat) (statements of Employee #2).
5
Affidavit of Employee #3, Dec. 6, 2016, 2, attachment 3 [hereinafter Employee #3 Aff.].
6
Redacted video.
7
Employee #1 Aff. 5.
8
Id. 5; Employee #3 Aff. 2.
1
2

112

Employee #1 also alleged that

performed numerous abortions during the third
trimester in cases that did not involve any serious threats to the mothers or the infants health.9
Employee #2 asserted, As long as the patients had the cash, he was going to do it past the 25
weeks.10 Four photographs identified by Employee #1 and Employee #3 as taken in the
sterilization room of the Womens Pavilion in 2012 depict the remains of infants clearly in their
third trimester when they were allegedly terminated by
.11 According to Employee #1,
the tears in the neck line visible in the photos are inconsistent with terminations done while
the infant[s were] entirely inside the uterus.12 Thus, besides being late-term abortions, they were
likely either partial-birth abortions or homicides committed after full delivery.
Employee #1 and two other employees at the clinic, Employee #3 and Employee #4, additionally
allege that the doctor regularly falsified sonogram results to misrepresent the gestational age of
the fetus. Some sonograms, they maintain, would be falsified to overstate the gestational age of
the fetus in order to overbill customers.13
In other cases, according to Employee #1 and Employee #3, sonograms would be falsified to
conceal the advanced gestational age of the fetus beyond the legal limit in Texas.14 Employee #1
claimed:
I have witnessed this happen in cases involving fetuses as old as 28 weeks.
would typically tell his ultrasound technician in cases involving fetuses
beyond a certain gestational age to allow him to perform the ultrasound himself;
he would then bring the patient an ultrasound picture showing another fetus at the
gestational age he was misrepresenting to the patient.15
An affidavit from a patient attached hereto alleges another specific case of manipulation: Patient
#1, a woman who obtained an abortion in 2002 at 24 to 25 weeks gestation, worried that I
was too far along. The girl doing my ultrasound told me that ultrasounds can be manipulated.
The clinic determined me to be 23 weeks.16 On two occasions that I witnessed, Employee #1
also alleges that
failed to inform a patient she was pregnant with twins.17
According to Employee #1 and Employee #3, the doctor would regularly make use of pre-drawn
medicine, including Demerol and Nubain, without properly logging or storing it. They added:
This included improperly storing medicine in a food refrigerator. On one
occasion,
concealed these practices during an inspection from the

Employee #1 Aff. 6.
Redacted video.
11
Employee #1 Aff. 6; Employee #3 Aff. 3. According to Employee #3, the photos were taken July 26, 2012. Id.
12
Employee #1 Aff. 6.
13
Id. 7; Employee #3 Aff. 4; Statement of Employee #4, Nov. 23, 2012, attachment 4, at 1.
14
Employee #1 Aff. 7; Employee #3 Aff. 4.
15
Employee #1 Aff. 7.
16
Affidavit of Patient #1, June 17, 2013, attachment 5.
17
Employee #1 Aff. 8.
9

10

113

Harris County Public Health office by having a nurse put pre-drawn medicine in
basins, which she hid in the trunk of her car while the inspector was present.18
Employee #1 and Employee #3 also allege the doctor failed to keep a registered nurse on site in
the recovery room at Aaron, which left unqualified workers to draw and administer drugs.19
Employee #1 added that
concealed this deficiency from authorities by hir[ing] a
nurse from a temp agency for a few days at a time when a government inspection was
scheduled.20 Employee #1 recorded examples of storage, recordkeeping, and personnel
violations in an undercover video from 2011 attached hereto.21
Additionally, according to Employee #1:
would regularly fail to observe proper sterilization procedures. This
included the doctors habitual reuse of a bottle of Betadine, which is used for
cleaning prior to the procedure, that was not cleaned or stored, and which he
handled with his gloved hand for patient after patient when going inside the
cervix. Additionally, after removing instruments such as Hawkins-Amblers
dilators and Bierer and Sopher forceps from sterile packages, he would place
unused instruments back in the sterile package to use on other patients. He often
would do so wearing gloves that he did not change between seeing one patient
and another, or between trips to the restroom. . . . Instruments in
s
clinic were not regularly soaked in sterilizing solutions as they needed to be for
specified periods of time in order to be sterile. The exception to this occurred
prior to government inspections. The vast majority of the doctors assistants in the
sterilization room were uninformed on proper methods of sterilization. In order to
reduce his costs,
also habitually disposed of biohazardous waste in
standard garbage bags instead of sterile bags required for such waste.22
The same failure with respect to sterilization was also alleged by Employee #2, Employee #3, and
Employee #4.23
Violations of Applicable Laws
Federal law makes clear that infants that are born, regardless of whether naturally or by
extraction during an abortion, are entitled to the same protections given to every other person.
Under the Born-Alive Infants Protection Act of 2002, every infant member of the species homo
sapiens who is born alive at any stage of development is considered a person.24 This is so
Id. Aff. 9; Employee #3 Aff. 5. See also Redacted video.
Employee #1 Aff. 10; Employee #3 Aff. 6.
20
Employee #1 Aff. 10. For additional information regarding the deficiencies in
s nursing staff and
other allegations regarding possible violations at his clinics, see Statement of Employee #1 in support of Complaint
against
D.O., Apr. 26, 2010, attachment 6.
21
Aaron Womens Clinic video by Employee #1, attachment 7.
22
Employee #1 Aff. 11-12. See also Statement of Employee #1 in support of Complaint against
D.O., Apr. 26, 2010, attachment 6, at 3.
23
Redacted video; Statement of Employee #4, Nov. 23, 2012, attachment 4, at 1.
24
1 U.S.C. 8(a).
18
19

114

whenever an infant undergoes "complete expulsion or extraction from his or her mother" and
"has a beating heali, pulsation of the umbilical cord, or definite movement of voluntary muscles,
regardless of whether the umbilical cord has been cut, and regardless of whether the expulsion or
extraction occurs as a result of natural or induced labor, cesarean section, or induced abOliion.,,25
The Partial-Bilih Abortion Ban Act of2003 makes clear that such protections apply even if the
infant is only partially extracted from the mother's body at the time its life is ended. Specifically,
a prohibited "paliial-bilih abortion" occurs when a person knowingly commits "an oveli act ...
that kills the partially delivered living fetus" after the fetus is partially delivered with its entire
head "outside the body of the mother, or, in the case of breech presentation, any part of the fetal
trunk past the navel.,,26 The only exceptions occur when such a procedure "is necessary to save
the life of a mother whose life is endangered" by certain categories of physical conditions 27
Violations of the 2003 act are punishable by fines, imprisonment for up to two years, or both 28
The foregoing allegations advance numerous federal violations against
-of the
Partial-Birth Abortion Ban Act in those cases involving his terminations of partially delivered
infants and of the Born-Alive Infants Protection Act in those cases where the infants have
completely exited a mother's body. In at least the latter cases, they also amount to allegations
that
violated Texas' climinal homicide statutes. First, the allegations constitute
murder, defined by the Texas Penal Code as " intentionally or knowingly caus[ing] the death of
an individual.,,29 Second, the allegations against
constitute capital murder under
Texas law in both ofthe following circumstances, either one of which is sufficient to establish
that offense:

"the person murders more than one person ... during different criminal transactions but
the murders are committed pursuant to the same scheme or course of conduct;,,30 and

"the person murders an individual under 10 years of age . .. .,,3 1

The murders alleged against

occurred on a repeated basis, and all occurred pursuant
to his course of conduct as a provider of abortion who was alleged to have systematically killed
any infant aborted while showing signs oflife. The second circumstance is independently
established by the obvious fact that every alleged victim was under 10 years of age.
's alleged conduct would also violate the gestational age limit established under
Texas law. Former employees of the doctor allege he performed abortions as late as the third
trimester. 32 Third trimester abortions are prohibited with narrow exceptions, inapplicable
according to the allegations in the instant case, where "the abortion is necessary to prevent the
death of the woman," the "unborn child has a severe, irreversible brain impainnent; or . . . the
woman is diagnosed with a significant likelihood of suffering imminent severe, irreversible brain
I U.S.C. 8(b).
18 U.S.C. 153 1(b)(I).
27 18 U.S.C. 153 1(a).
28 Jd.
29 Tex. Penal Code 19.02(b)(l).
30 Tex. Penal Code 19.03(a)(7).
31 Tex. Penal Code 19.03(a)(8).
32 Employee # 1 Aff. ~ 6; Employee #3 Aff. ~ 2.

2>

26

5
115

damage or ... paralysis."33 Since H.B. 2 became effective October 29,2013, abortions
additionally have been prohibited when "the probable post-fertilization age of the unborn child is
20 or more weeks.,,34
's abortion practice is believed to continue to the present day, so
it merits investigation whether he has violated both gestational limits.
The allegations that
regularly falsified sonogram results to misrepresent the
gestational age of the fetus also potentially implicate both state and federal law. Regardless of
whether the patient or another entity is responsible for payment, Texas law clearly prohibits
fraudulent billing. Such conduct would constitute a form oftheft 35 in addition to violating Texas'
prohibition on insurance fi"aud 3 6 In those cases in which patients were eligible for Medicaid
coverage, such allegations would implicate numerous federal criminal prohibitions on false
statements to federal agencies 3? and on false statements involving health care benefit programs,38
as well as the prohibitions on health care fraud 39 Such conduct would also violate the federal
False Claims Act40 and Texas' prohibition of Medicaid fraud 41
Other provisions of Texas law prohibit additional conduct alleged above on the part of
, including the following:

Misrepresentation of sonogram readings: In addition to violating the above-cited statutes

prohibiting fraud, tampering and altering records containing patient data is prohibited
under 25 Tex. Admin. Code 135.9(d).

Failure to properly store and log medication: The obligation to maintain and provide
drugs safely and to properly log their use is set forth in detail under 22 Tex. Admin. Code
291.76 and made applicable to ambulatory surgical centers under 25 Tex. Admin. Code
135.12.

Lack of adequate medical staff: 25 Tex. Admin. Code 135.7 requires health care
practitioners to meet numerous requirements that include necessary and appropriate
training and to adhere to state law and "the standards and ethics of their professions." 25

Tex. Occ. Code 164.052(a)(18). The Texas Health and Safety Code contains an additional prohibition of thirdtrimester abortions, under which such abortions are permitted only when they are "necessary to prevent the death or
a substantial risk of serious impainnent to the physical or mental health of the woman" or "the fetus has a severe and
irreversible abnormality," in which case the physician is required to submit a written certification of the applicable
conditions to the Department of State Health Services. Tex. Health & Safety Code 170.002(b)-(c).
34 Tex. Health & Safety Code 171.044, 171.045. Exceptions apply when abortion is deemed necessary "to avert
the woman's death or a serious risk of substantial and irreversible physical impairment of a major bodily function,
other than a psychological condition." Tex. Health & Safety Code 17 1.046. Note that these provisions ofH.B. 2
were not challenged in Whole Woman's Health v. Hellerstedt, 136 S. Ct. 2292 (2016).
" Tex. Penal Code 3 1.03.
36 Tex. Penal Code 35.02 .
J7 18 U.S.C. 1001 ; 18 U.S.C. 287. An accompanying prohibition on conspiracy in connection with such claims is
established by 18 U.S.c. 286.
J8 18 U.S.C. 1035.
J9 18 U.S.C. 1347; 42 U.S.c. 1320a-7b(a). Iffraud is proven to have been carried out by utilizing either the mails
or other applicable interstate carriers or communications, the federal mail and wire fraud statutes would also be
implicated. See 18 U.S.C. 1341 , 1343.
40 3 1 U.S.C. 3729(a)(1).
41 Tex. Penal Code 35A.02.
33

6
116

Tex. Admin. Code 135.15 specifies requirements for an organized nursing service
under the direction of a qualified registered nurse and other personnel that must be
present at the medical facility.
s fonner employees' all egations amount to a
violation of these sections. Additional investigation is warranted into whether clinic
practices were in compliance with other requirements for adequate medical staff,
including 25 Tex. Admin. Code 135. 10, which addresses additional facility
requirements, and 25 Tex. Admin. Code 135.11, which addresses anesthesia and
surgical services.

Failure to observe proper sterilization procedures and disposal practices: 25 Tex. Admin.
Code 135.1 I (b)(12) requires the development, implementation, and enforcement of
such procedures, and 25 Tex. Admin. Code 135.52(d)(14) requires sterilizing facilities
to be included and properly maintai ned and utilized.

Fraudulent concealment from government authorities ofthe foregoing all eged violations:
The fabrication, alteration, and in applicable cases concealment involved in these
allegations entail conduct proscribed by Tex. Penal Code 37.09. It also subverts the
state's right to inspect facilities containing controlled substances pursuant to Tex. Health
& Safety Code 481.181.

was previously referred to the District Attorney of Harris County, but the
investigation into the matter was deficient. In light of the gravity of the allegations outlined
above and the supporting documentation, I urge your office to conduct a thorough investigation
into whether
violated federal and state law, and, if you agree that such violations
OCCUlTed, to take all appropriate action. If you have any questions about thi s request, pl ease
contact Frank Scaturro, at (202) 225-2927, [email protected].
Sincerely yours,

Select Investigative Panel

Attachment(s)

cc:

The Honorable Jan Schakowsky

Ranking Member
Select Investigative Panel

7
117

118

119

120

121

122

123

ONE HUNDRED FOURTEENTH CONGRESS

(tCongress of tbe Wniteb

~tates

T!)ouse of l\epresentatibes

COMMITTEE ON ENERGY AND COMMERCE

2125

RAYBURN H OU SE OFFI CE BUILDING

WASHINGTON,

DC 20515-6115

Majo rity (202) 225- 2927

M ino rity (202) 225- 3641

December 20, 2016

VIA EMAIL
The Honorable Loretta Lynch
Attorney General
clo Office of Legislative Affairs
U.S . Department of Justice
950 Pennsylvania Ave., NW
Washington, DC 20530
Dear Attorney General Lynch:
On October 7, 20 15, the U.S. House of Representatives passed H. Res. 461, which created the
Select Investigative Panel (the " Panel") and empowered it to conduct a full and complete
investi gation regarding the medical practices of abortion providers and the practices of entities
that procure and transfer fetal tissue.
The Panel investigation discovered information that StemExpress, LLC ("StemExpress"), a firm
that procures fetal ti ssue from abortion clinics and transfers it to research customers, may have
destroyed documents in violation of Title 18 U.S.C. 1519. The transfer offetal tissue for
valuable consideration is a matter within the jurisdiction of the United States. Specifically, Title
42 U.S.C. 289 (g) makes it a felony to receive valuable consideration for fetal ti ssue in excess
of allowable costs.

From July 16,2015 through the passage ofH. Res. 461, the Senate Committee on the Judiciary
("Senate Judiciary"), the House Committee on Energy and Commerce ("Energy and
Commerce"), and the House Committee on Oversight and Government Reform ("OGR") all
conducted inquiries into the fetal tissue industry. The Senate Committee on the Jud iciary' s
investigation still continues. During the course of those congressional inquiries, all of those
- - - -- 'committees sen documenneques letters"to StemExpress.
Under 18 U.S .C. 1519, "Whoever knowingly alters, destroys, mutilates, conceals, covers up,
fa lsifies, or makes a false entry in any record, document, or tangible object with the intent to
impede, obstruct, or influence the investigation or proper administration of any matter within the

124

jurisdiction of any department or agency of the United States"] commits a fe lony that is
punishable by impri sonment for up to 20 years2
The Panel has discovered a regime of StemExpress' potential destruction of documents that were
the subject of congressional inquiries, document request letters, and subpoenas. This regime,
which dates back to August 20 15 and continues through the present, involves StemExpress'
retention of a company that shreds documents for clients, and the production of accounting
records that were created by Stem Express' counsel, which the counsel represented were
produced by StemExpress itself.
A. Destruction of Documents

Senate Judiciary Committee

On July 16,20 15, Senate Judiciary sent StemExpress a document request letter for all records
relating to StemExpress' communications with a senior official of Planned Parenthood, and with
Planned Parenthood itself that related to "the central ization or coordination of StemExpress'
acquisition of feta l ti ssue from Planned Parenthood 's individual affiliates ... "3 On July 24, 2015,
StemExpress produced only copies of its contract with Planned Parenthood affiliates. 4
On August 13,2015, StemExpress made its first payment to Shred-It-USA. 5 StemExpress bank
records dating back to November 20 12 reveal there were no payments made to Shred-It USA
before August 13 ,2015 6 On August 19, 2016, StemExpress made a second production to Senate
Judici ary 7
On August 25, 20 15, StemExpress made its second payment to Shred-It-USA. 8 On September
17,2015, Senate judiciary sent its second document request letter to StemExpress. 9 On
September 17, 20 IS , StemExpress produced documents to Senate Judiciary.]O On September 24,

I IS U.S.c. 15 19.
' IS U.S.C. 1519.
3 Letter from Sen. Charles E. Grass ley, Chairman, Senate Committee on the Judiciary, to
Founder and
CEO, Stem Express, (Jul. 16,2015), at 2.
4 See Letter from Stephen M. Ryan, McDermott Will & Emery, to Sen. Charles E. Grassley, Chairman, Senate
Committee on th e Jud iciary, Re: Stem Express Response to Senate Judiciary Committee's July 16, 20 15 Request for
Information, (Jul. 24 , 2015).
, Panel analysis of Five Star Bancorp production to Select Investigati ve Panel.
6 Five Star Bank Production [5 Star 00000 I - 5 Star 000511].
7 See Letter from Stephen M. Ryan, McDermott Will & Emery, to Sen . Charles E. Grassley, Chairman, Senate
Committee on the Judi ciary, Re: Stem Express Second Response to Senate Judiciary Committee's July 16,20 15
Request for Information, (Aug. 19,2015).
8 Panel analysis of Five Star Bancorp production to Select Investigative Panel.
9 See Letter from Stephen M. Ryan, McDermott, Will & Emery, to Sen. Charles E. Grass ley, Chairman, Senate
- - - -- - ,Committee on the Judiciary, Re: Stem Express Second Response to Senate-.ruaic iary Committee's Septemberi7,
20 15 Request for Information, (Oct. 2S, 2015). ("I am writing today on behalf of my client, Stem Express, in regard
to the letter you sent to the company on September 17, seeking information re lated to Stem Express; ' acquisition and
transfer of fetal tissue. "').
10 Letter from Stephen M. Ryan, McDermott, Will & Emery, to Sen. Charles E. Grassley, Chairman, Senate
Comm ittee on the Judiciary, Re: Stem Express Second Response to Senate Judiciary Committee's September 17,

2
125

2015, StemExpress produced documents to Senate Judiciary. I I On September 29, 2015,

StemExpress made a payment to Shred-It-USA.1 2 On October 28 , 2015 , StemExpress produced
documents to Senate Judiciary . 13
Energy and Commerce
On August 7, 2015, Energy and Commerce sent a letter to StemExpress that requested a bri efing
related to StemExpress' procurement, sale and donation offetal tissue. 14 On August 13,2015 ,
StemExpress made its first payment to Shred-It-USA. I s On August 21,2015, StemExpress
produced documents to Energy and Commerce. 16
The briefing between StemExpress and Energy and Commerce staff was held on August 25 ,
2015. On Augu st 24, 2015 Stem Express voluntarily produced documents to Energy and
Commerce. 17 Congressional staff requested additional information and documents from
StemExpress.18 On August 25, 2015, StemExpress made its second payment to Shred-It-USA. 19
On September 11, 2015 StemExpress produced documents pursuant to the requests from the
Majority and Minori ty 20

20 IS Request for Information, (Oc!. 28, 20 IS). ("StemExpress made an initial production in response to the
September 17 letter shOltly after receipt . , .").
11 Letter from Stephen M, Ryan, McDermott Will & Emery, to Sen. Charles E. Grassley, Chairman, Senate
Comm ittee on the Judiciary, Re: Stem Express First Re sponse to Senate Judi ciary Committee's September 17, 20 IS
Request for Information, (Sep. 24, 20 IS ).
12 Panel analysis of Five Star Bancorp production to Select In vestigative Panel.
13 Letter from Stephen M. Ryan, McDermott, Will & Emery, to Sen. Charles E. Grassley, Chairman, Senate
Committee on the Judiciary, Re: Stem Express Second Response to Senate Judiciary Committee's September 17,
20 IS Request for Information, (Oct. 28, 20 IS).
14 Letter from Stephen M. Ryan, McDermott Will & Emery, to Rep. Fred Upton, Chairman, House Energy &
Commerce Committee, Re : Stem Exp ress Response to House Energy and Commerce Committee's August 7, 2015
Request for a Briefing, (Aug. 21,2015), at I. ("I am wr iting today on be half of my client, Stem Express, in regard to
the letter yo u sent to the company on August 7, 2015, seeking a briefin g related to Stem Express's ' practices
regarding human feta l tissue collection, sale andlor donation ."'),
" Panel analysis of Five Star Bancorp production to Select Investigati ve Panel.
16 Letter from Stephen M. Ryan, McDermott Will & Emery, to Rep, Fred Upton, Chairman, House Energy &
Commerce Committee Re: StemExpress Response to House Energy and Commerce Committee's August 7, 20 15
Request for a Briefing, (Aug. 21 , 2015).
17 Letter from Stephen M. Ryan, McDermott Will & Emery, to Rep. Fred Upton, Chairman, House Energy &
Commerce Committee, Re: StemExpress Response to House Energy and Commerce Committee's August 7,2015
Request for a Briefing, (A ug, 24, 20 15), at I . (" In advance of our vo luntary briefi ng to staff scheduled for August
25, we are vo luntaril y responding to the staff s request by prod ucing several documents to facilitate our

discussion,").

18 Letter from Stephen M, Ryan, McDerm ott Will & Emery, to Rep. Fred Upton, Chai rman, House Energy &
Commerce Committee, (Sep. 11 ,2015), at 1. ("As you know, StemExpress's CEO,
voluntarily agreed to
- - - -- --.:provide a briefing to the Committee's staff on August 2S~01l0wing this oriefiiig,both t e ajority anOMinority
staff provided Stem Express with a list of20 additional reques!.").
19 Panel ana lysis of Five Star Bancorp production to Select Investi gati ve Panel.
20 Letter from Stephen M, Ryan, McDermott Will & Emery, to Rep. Fred Upton, Chairman, House Energy &
Commerce Committee, Re: Stem Express Th ird Response to House Energy and Commerce Committee's August 7,
20 IS Request for a Briefing (Follow-Up Req uests), (Sep. 11,2015), at I,

3
126

On September 9, 2015, OGR sent a document request letter to StemExpress. 21 StemExpress

produced documents to OGR on September 2, 2015 and September 23 , 2015 22 On September
29,2015, StemExpress made a payment to Shred-It-USA. 21 On October 9, 2015, StemExpress
produced more documents to OGR.24

The Panel
The Panel was created on October 7, 2016. On November 10,2015 StemExpress made a
payment to Shred-It-USA.2s On December 10,2015, StemExpress made another payment to
Shred-It-USA. 26 During that time period, StemExpress was under investigation by Senate
Judiciary and OGR.
On December 17, 2015, the Panel sent Stem Express a document request letter 27 On December
18 , 2015, congressional staff had a telephone conference with counsel for StemExpress to
discuss the document request. On December 22, 2015 , StemExpress produced documents to the
Panel 28
On January 12,2015, StemExpress made a payment to Shred-It-USA 29 On January 15,2015,
StemExpress produced documents to the Panepo On January 27, 2015, StemExpress made a
21

Letter from Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Jason Chafettz, Chairman, House Committee

on Oversight and Government Reform, Re: Stem Express First Response to House Committee on Oversight and
Government Reform's September 9, 2015 Request for Infomnation, (Sep. 23, 2015), at I. ("I am writing today on
behalf of my client, Stem Express, in regard to the letter you sent to the company on September 9, 2015, seeking

documents and information regarding 'the process whereby StemExpress obtained fetal tissue from Planned

Parenthood Federation of America ... "').

22 Letter from Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Jason Chafettz, Chairman, House Committee
on Oversight and Government Reform , Re: Stem Express First Response to House Committee on Oversight and
Government Reform's September 9, 2015 Request for Information, (Sep . 23, 2015), at I. ("As an initial matter,
StemExpress voluntarily produced several documents to the Committee's staff on September 2, 2015. Accordingly,

today's production represents StemExpress's second voluntary response to the Committee's inquiries ... ").
23 Panel analysis of Five Star Bancorp production to Select Investigative Panel.

24 Letter from Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Jason Chaffetz, Chairman, House Committee
on Oversight and Government Reform, Re: Stem Express Second Response to House Committee on Oversight and
Government Reform's September 9, 2015 Request for Information, (Oct. 9, 2015).
25 Panel analysis of Five Star Bancorp production to Select Investigative Panel.
26 Panel analysis of Five Star Bancorp production to Select Investigative Panel.
27 Letter from Rep. Marsha Blackburn, Chairman, House Select Investigative Panel, to
Founder and
CEO, Stem Express, LLC (Dec. 17,2015). The letter sought, among other items, asking for, among other items, a list
of all entities from which it procured fetal ti ssue, a list of all entities to which it so ld or donated fetal tissue, an
organization chart, all communications that direct its employees to procure fetal ti ss ue, a list of all federal funds the

firm received, accounting records, and all Stem Express banking records related to the procurement, sale, donation,

or distribution or shipment of fetal tissue.

28 Letter from Stephen M. Ryan , McDermott Will & Emery, to Rep. Marsha Blackburn, Chair, Select Panel on
- - - - -- rnfanfTives, e: Stem xpress esponse to ouse " Selecf Panel onTnfantcives''L)ecemoer 17, 20rS"Request for
Documents, (Dec. 22, 2015).
29 Panel analysis of Five Star Bancorp production to Select Investigative Panel.
30 Letter from Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Marshal Blackburn, Chair, Select Panel on
Infant Lives, Re: Stem Express LLC Second Production in Respo nse to House "Select Panel on Infant Lives"
December 17, 2015 Request for Documents, (Jan. 15,2016).

4
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payment to Shred-It-USA. 3 \ On February 1,2016, StemExpress produced documents to the

Panel.J2
On February 12, 2016, the Panel issued a subpoena to StemExpress 33 The subpoena to
StemExpress instructed that: "No records, documents, data or information called for by this

Panel analysis of Five Star Bancorp production to Select Investigative Panel.

Letter 1T0m Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Marsha Blackburn, Chair, Select Panel on
Infant Lives, Re: StemExpress LLC Third Production to House "Select Panel on In fant Lives" December 17, 20 15
Request for Documents, CFeb. 1,2016).
]] Subpoena to StemExpress, LLC, CFeb. 12,2016). The subpoena demanded the following:

31

32

I) Documents sufficient to show Ca) all entities 1T0m which Stem Express procured fetal tissue, and Cb)
all entities to which StemExpress transported, sold, donated, moved, or shipped fetal tissue. Should
StemExpress wish to produce a list of such entities referenced in Ca) and Cb) in lieu of documents, it
may do so.
2) Documents sufficient to show the name and title of all StemExpress cUlTent and former employees

whose responsibilities included procuring, researching, storing, packaging for donation, sale, transport,

or disposal of fetal tissue, and the identity, of any supervisory personnel under whom such individuals
worked.

3) All communications and documents relating to StemExpress employee compensation resulting from

or relati ng to fetal tissue samp les procured by current and former Stem Express personnel or other

persons or entities that transact business wi th Stem Express .

4) All communications and documents that identify any federal, state, or local government funds

received, directly or indirectly, by StemExpress.

5) All communications refelTing or relating to abortion or fetal tissue between StemExpress and any
federal, state, or local government officials or employees.

6) All communications and documents regarding any direction to Stem Express current or former
personnel with respect to the procurement or disposal of fetal tissue.
7) All communications and documents that Stem Express utilizes to obtain patient consent for fetal tissue
at any clinic .
. . . 8) All communications and documents, including but not limited to accounting memoranda,
referring or relating to the cost and pricing of fetal tissue by StemExpress.
9) All communications and documents, sorted by customer, referring or relating to requests or orders
made to StemExpress regarding fetal tissue and the amount paid by each customer to Stem Express.

10) All communications and documents referring or relating to the purchase, ownership, or rental by
StemExpress of equipment for the storage, disposal, modification, or research of fetal ti ss ue, including
equipment price, purchase date, maintenance costs, and records of the depreciation treatment under the
tax code of any such equipment.
11) All Stem Express banking and accounting documents, sorted by any source of fetal tissue and any
customer of Stem Express, that reflect accounts payable and/or funds received that in any way refer or

relate to the procurement, sale, donation, or distribution or shipment of fetal tissue.

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request shall be destroyed, modified, removed, transferred or otherwise made inaccessible to the
Select Panel."34 On March 21, 2016, StemExpress made a payment to Shred-It-USA 35 On
March 28, 2016, StemExpress produced documents to the Panel pursuant to the sUbpoena. 36
On April 26, 2015, StemExpress made a payment to Shred-lt-USA. 37 On May 10, 2016,
StemExpress produced documents to the Panel pursuant to the February 2016 subpoena 38
b. Intent to Obstruct
Documents produced to Congress and testimony before congressional inquiries strongly suggest
StemExpress' intent to potentially subvert congressional investigations. The investigations
involve matters within the jurisdiction of the United States. An attempt to obstruct such an
investigation would violate Title 18 1519.
In productions to Senate Judiciary, OOR, and the Panel, Stem Express refused to provide
congress with a list of all the entities from which it obtained fetal tissue. 39 StemExpress refused
to produce to the Panel requested accounting documents, StemExpress represented that it had
lost money on fetal tissue procured from Planned Parenthood affiliates. 4o

12) Documents sufficient to show any known litigation in which StemExpress is named as a party,
including any threatened or anticipated litigation. Should Stem Express wish to produce a list of such
litigation, including appropriate docket information, in lieu of documents, it may do so.
Subpoena to StemExpress, LLC (Feb. 12,2016) (Schedule).
Subpoena to Stem Express, LLC, at Instruction Item 5, (Feb. 12,2016).
3l Panel analys is of Five Star Bancorp production to Select Investigative Panel.
36 Letter to Rep . Marsha Blackburn, Chai r, Select Panel on Infant Lives, Re: Fourth Production in Re sponse to
February 12, 20 16 subpoena Issued to Stem Express LLC, (Mar. 28, 2016).
37 Panel ana lysis of Five Star Bancorp production to Select Investigative Panel.
38 Stem Express Sixth Response to House Select Panel Subpoena Produced on May 10,20 16.
[STEM.HOUSE.SELECT_0908 - STEM.HOUSE.SELECT_0913].
19 See StemExpress Second Response to Senate Ju diciary Committee September 17 Letter, undated. ("Stem Express
has obtained fetal tissue from two Planned Parenthood affi liates .... StemExpress has also obtained fetal tissue
from five independent (non-Planned Parenthood) clinics. Stem Express agrees to identify the states where it has
agreements with independent clinics, but will not be providing the names of these clinics ... ").
[STEMJUD000000024; STEM.HOUSE.SELECT_0057j. Stem Express Response to I-louse Comm ittee on
Oversight and Government Reform, (Dec. 22, 2015). ("Stem Express has obtained fetal tiss ue from two Planned
Parenthood affi liates ... and from independent (non-Planned Parenthood) clinics. Stem Express agrees to identify
th e states where it has agreements with independent clinics, but will not be providing the names of these clinics ..
.") [STEM.HOUSE.ORG_OOOOI8 ! STEM. HOUSE.SELECT_0184]. Stem Express First Respon se to House Select
Panel Document Requests (Jan. 15,2016), at 2. (" ... many of the company's contracts are subject to non-disclosure
agreements and, therefore, cannot be vo luntarily produced.") [STEM.HOUSE.SELECT_0228].
40 Stem Express First Response to House Select Pane l Document Requests (Jan. 15 ,2016), at 6. (" ... unaltered fetal
tiss ue procured from Planned Parenthood affi liates generated approximately $50,000 in gross (pre-tax) reven ue
against expenses in excess of$75,000. StemExpress charged researchers a fee of roughl y $500 to $600 for unaltered
- - - -- - tissues, but incurred directly associated expenses of approx imately $750 to $1 ,000 for each procurement. Other costs
inc lud ed compensation paid to Stem Express' tissue procurement personnel and costs assoc iated with training,
packagi ng and ordering supplies, overnight shipping charges, infectious disease screening ... " ).
[STEM.HOUSE.SELECT_0232]. StemExpress invoices produced to the Panel show that Stem Express charged its
customers the costs of infectious disease screening, overn ight shipping charges, and some supplies. Those charges
cannot have been incurred by both Stem Express and its customers.
34

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In response to the Panel' s February 12,20 16, subpoena StemExpress produced communications
that spanned on ly two years instead of the five required by the subpoena and these were so
replete with redactions as to render them unusable. 41 StemExpress produced only "roll-up"
accounting summaries, not the required primary source accounting records. 42
In response to Specification 4, which required the production of communications and documents
that identi fy any federal, state, or local government funds received, directly or indirectly, by the
firm, StemExpress responded that it had nothing responsive to produce. ("StemExpress has
confirmed that there are no communications or documents responsive to thi s ... ,,).43 Despite that
representation, the Panel discovered that StemExpress received more than $9,000 in a small
business loan from the U.S. Small Business Administration 44
refused to produce any documents to the Congress pursuant to the Panel's March 29,
supplied the name of the Scinto Group, LLP ("Sci nto"), an
20 16 subpoena to her 45
outside accounting firm that provided services to StemExpress, and suggested that the Panel seek
a former emp loyee of
the information it required from Scinto or from
StemExpress. 46 Attorneys for
offered summary documents of revenue and costs but no
accounting records. 47
offer of
as a source of accounting records proved hollow.
and StemExpress' counsel, who also represented former employee
explained that
had only W-2 's and related tax information. In a teleconference with
Congressional staff,
stated that she had no documents and that if the Panel contacted her
again she would call the police 48
On April 29, 20 16, the Panel issued a subpoena to Scinto. 49 Scinto refused to comply with the
Panel's subpoena and produced no documents. Scinto told the Panel that StemExpress objected

See Stem Express, Third Response to House Select Invest igative Pane l Subpoena, Apr. I 1,20 16.
[STEM.HOUSE.SELECT_0667].
42 See Lette r ITom Amandeep S. Sidhu, McDermott Wi ll & Emery, to T. March Be ll, Chief Counsel and Staff
Di rector, House Select Investigative Pane l (Mar. 18,2016), at I; Letter ITom Amandeep S. Sidhu, McDermott Will
& Emery, to Rep. Blackburn, Chairman, House Select In vestigative Panel (May 6, 2016), at 2.
43 See StemExpress, Third Response to House Select Investigative Panel Subpoena, Apr. 11 ,20 16.
[STEM.HOUSE.SELECT_0667].

41 41

44

Center for Effective Government website, www.FedSpending.org.

4' "Stem Express First Response to House Select Panel's March 29, 20 16 Subpoena," at 2-3.

"Stem Express First Response to House Select Panel's March 29, 20 16 Subpoena," at 2-3.
"Stem Express First Response to House Select Panel' s March 29, 20 16 Subpoena," at 1-2.
48 Memorand um fro m House Select Investigat ive Pane l Counsel to Majority Members of the House Select
In vestigative Panel, Mar. 7, 2016.
49 Subpoena to Scinto Group, LLP, (Apr. 29, 20 16). The subpoena requ ired th e production of:

46
41

f) All communications and doc uments referrin g or relating to Stem

Stem Express Foundation (collectively known as "StemExpress").

C, or

2) Documents sufficient to show all inst itutions or entities to whi ch Stem Express donated or provided
feta l tiss ues forthe following years: 20 I 0, 20 11 ,20 12,2013,2014 and 20 15.

7
130

to Scinto's compliance with the Panel 's subpoena on the grounds of several privileges. 5o The
Panel informed Scinto its objections based upon the asserted privileges, were inapplicable and do
. .. 3) Copies of all invoices (by month and year), reflecting the billing that StemExpress issued to all
institutions or entities to which Stem Express donated or provided fetal tissues for the following years:
2010,2011,2012, 20 13,2014 and 2015.

4) Documents sufficient to show all institutions or entities from which Stem Express

obtained fetal tissues for the following years : 20 I 0,20 11,2012,2013,2014 and 20 IS .
. . . 5) Copies of all invoices (by month and year) reflecting the billing or payment of funds for fetal
tissues obtained by Stem Express for the following years: 20 I 0,20 11,2012,2013,2014 and 2015.

6) A copy of any chart of accounts for Stem Express, including but not limited to account descriptions
from any financial recording system relating to Stem Express.
7) StemExpress' end of year trial balance repOlt and trial balance details for the following years: 20 I 0,
2011,20 12,20 13,20 14 and 20 15.
8) All documents reflecting StemExpress' statement of revenues (i.e., a breakdown by
product categories) for the following years: 20 I 0,20 11,2012,2013, 2014 and 2015.
9) All documents reflecting StemExpress' record of costs and expenses (i.e., a breakdown by operations,

including feta l tissue acquisition ) for administrative costs and expenses as we ll as compensation and

benefits, for the following years: 2010, 2011, 2012, 2013, 2014 and 2015. Where applicable, records

should include identification of vendors and descriptions of expenses.

10) Stem Express' balance sheets for the following years: 20 I 0, 20 II, 2012, 2013, 2014 and 2015.
Audited statements should be provided, if available.
II) StemExpress' income statements, including but not limited to any profit and loss
statements, statements of operations and statements of activities for the following years: 20 I 0, 20 II,
2012,2013,2014 and 20 IS. Audited statements should be provided, if available.
12) Copies of Stem Express' filed tax returns forthe following years: 20 I 0, 20 11,2012,2013,2014 and
2015.
13) All Stem Express bank statements from any financial institution where StemExpress has maintained
an account for the following years: 2010, 2011, 2012, 2013, 2014 and 20 15 .
14) Documents sufficient to show how Stem Express calculates the cost ofa fetal tissue and all factors
applied in determining pricing of fetal tissue. In lieu of these documents, you may provide a written
explanation.

IS) Documents sufficient to show Stem Express' cost of production and revenue from the following
products: CD34+StemlProgenitor Cells; CD36+ Erythroid Progenitor; CD 133 + Stem/ Progenitor
Cells; Fetal Fiver Mononuclear Cells. (Schedule).
50 See email from Kevin Murphy, counsel for Scinto Group LLP, to House Select Investigative Congressional staff
(Jun. 15,2016) ("Stem Express has now told me definitively that it does not waive any available and applicable
privileges or confidentiality rights in regard to the records related to Stem Express that are in the possession of my
- - - - -- -;elient, Scinto-;-and that Stem Express holds S'cinlo accountable to obser e and protect those privileges and
confidentiality rights. As you know, because Sc into is a CPA firm and tax preparer for StemExpress, there are
potentially applicable privileges and confidentiality statutes, under the Internal Revenue Code and related
provisions, under the California Business & Professions Code and Tax Code, and under professional standards.
understand that you probably do not agree that any of those laws or provisions would ultimately be found by a court
to be applicable, but from our reading of the laws and provisions, we believe that the privilege and confidentiality

8
131

not impair the legal requirement to comply with a congressional subpoena 5J Despite these
efforts, Scinto refused to comply with this Panel 's subpoena 52
In documents produced by an entity from which StemExpress procured fetal tissue, the Panel
discovered that StemExpress had an account at Five Star Bancorp. On April 29, 2016, the Panel
issued a subpoena to Five Star Bancorp. 53 During a telephone conference with congressional
staff, counsel for Five Star Bancorp stated that StemExpress had threatened litigation against his
client ifit complied with the Panel ' s subpoena 54
On August 23, 2016, the Panel was informed by McDermott Will & Emery, the law firm
previously representing StemExpress and
throughout the course of the investigation,
that StemExpress was no longer their client. 55 StemExpress' former attorney supplied the Panel
with contact information for the new lawyer 56 On September 8, 2016, Chairman Blackburn sent
a letter to Mr. Frank Radoslovich, the new counsel for Stem Express and
outlining a

laws/provisions could be found applicable. I have also reviewed con'espondence and a memorandum from the
Democratic members of the Select Investigative Panel which assert that the subpoena (and others) was issued in
violation of House rules. I have also reviewed articles (including the comprehensive articles by the Congress ional
Research Service) and court cases regarding enforcement of subpoenas from a House committee or subcommittee or
investigative committee. My conclusion, based upon a reading of all these materials, and in light of the position
conveyed to me by Stem Express, is that Scinto has an obligation to object to the subpoena.").
"See T. March Bell, Chief Counsel and Staff Director, House Select Investigative Panel, to Kevin Murphy, counsel
for Scinto Group, LLP (Sept. 8,2016).
52 See Letter from Kevin Murphy, counsel for Scinto Group, LLP, to T. March Bell, Chief Counsel and Staff
Director, House Select Investigative Panel (Sept. 16,2016) ("First, let me reiterate that, irnot for the potential
application of the privilege and/or confidentiality laws, Scinto Group LLP would be willing and ab le to comply with
a valid subpoena fTom the Select Investigative Panel. However, in light of the potential application of those laws,
under the current circumstances, Scinto Group is not in a position to unilaterally respond to the subpoena with the
requested documents, absent client consent.").
53 See Subpoena to Five Star Bancorp (Apr. 29, 2016). that required the production of:
For the period January 1,2010, through the present, all documents relating to any Five Star Bank
account(s) held by or in the name of Stem Express, LLC, and all documents relating in any way to
account number 0032068931.
This request encompasses, but is not limited to, all:

I) Monthly account statements;

2) Credit card transaction receipts;

3) Documents reflecting payments related to the account(s), including, but not limited to,
checks (front and back), debit memos, cash in tickets, and wire transfers; and
4) Correspondence related to the account(s).

- -- --

(Schedule).
Telephone conference between David R. Gabor, Weintraubi ob in Clrediak Coleman Grodin, and congressional
staff (May 26,2016).
55 Email from Amandeep S. Sidhu, McDermott Will & Emery, to House Select Investigative Panel staff (Aug. 23,
20 16) .
.. Email from Amandeep S. Sidhu, McDermott Will & Emery, to House Select Investigative Panel staff (Aug. 23,
20 16).

-!S4

9
132

brief history of the Panel' s interactions with StemExpress, and the Panel 's unsuccessful attempts
to reach an accommodation with StemExpress 57 The letter concluded:
Since StemExpress has been unwilling to comply with the Panel's
subpoenas and having exhausted all its efforts to obtain compliance
from the subpoena recipients, the Chairman of the Select
Investigative Panel will recommend that StemExpress and
be held in contempt for their willful failure
to fully comply with the Panel's subpoena issued to them .... S8
The Chairman provided one last offer to StemExpress and
to comply with the
subpoenas 59 After receiving no substantive reply from StemExpress' new counsel, the Panel, on
September 21, 2016, voted to recommend that the House of Representatives hold StemExpress
and
in contempt of Congress 60
Based on the facts outlined above and the supporting documentation, I request that the
Department of Justice conduct a thorough investigation into whether StemExpress committed
any violation of federal law during its evasive interactions with Congress. If you have any
questions about this request, please contact T. March Bell, Chief Counsel and Staff Director, at
(202) 226-9027, [email protected].

Sincerely yours,

Select Investigative Panel

Attachment(s)

cc:

The Honorable Jan Schakowsky

Ranking Member

" Letter ITom Rep. Marsha Blackburn, Chairman, House Select Investigative
for Stem Express (Sept. 8, 20 \6).
" Letter ITom Rep. Marsha Blackburn, Chairman, House Select Investigati ve
for Stem Express (Sept. 8,2016) at 4.
59 Letter ITom Rep. Marsha Blackburn, Chairman, House Select Investigative
for StemExpress (Sept. 8, 2016) at 4.
60 See Select Investigative Panel of the H. Comm. on Energy and Commerce,
Sep. 2 1, 2016.

10
133

Panel, to Frank Radoslovich, counsel

Panel, to Frank Radoslovich, counsel
Panel, to Frank Radoslovich, counsel
Business Meeting, unedited transcript,

134

135

V. Case Studies of the Fetal Tissue Industry The Middleman

Model
Chapter V Redaction Key:
StemExpress, LLC
1. [PP Witness #1] is an abortion provider in Los Angeles, California, an executive with
Planned Parenthood Federation of America (PPFA), and is charge of the PPFA
Manual of Medical Standards and Guidelines.
2. [PP Doctor #1] is an abortion provider in Los Angeles, California, who also works for
the Medical Directors Council.
3. [the Founder and CEO] is the founder and CEO of StemExpress, LLC (StemExpress)
4. [ABRs Procurement Manager] is the procurement manager at Advanced Bioscience
Resources, Inc.
5. [FDA Consumer Safety Officer # 1] is a consumer safety officer at the U.S. Food and
Drug Administration.
6. [FDA Consumer Safety Officer # 2] is a consumer safety officer at the U.S. Food and
Drug Administration.
Novogenix Laboratories, LLC
1. [PP Witness # 1] is an abortion provider in Los Angeles, California, an executive with
Planned Parenthood Federation of America (PPFA), and is charge of the PPFA
Manual of Medical Standards and Guidelines.
2. [PP Doctor #1] is an abortion provider in Los Angeles, California, who also works for
the Medical Directors Council.
3. [Founder and Executive Director] is the founder and executive director of Novogenix
Laboratories, LLC (Novogenix).
4. [Supervisor Consumer Safety Officer] is a supervisor consumer safety officer at the
U.S. Food and Drug Administration.
5. [Consumer Safety Officer] is a consumer safety officer at the U.S. Food and Drug
Administration.

136

DaVinci Biosciences, LLC/DaVinci Biologics, LLC

1. [DVB Executives] are the owners and managers of DaVinci Biosciences, LLC
(DaVinci) and DaVinci Biologics, LLC (DVB).
2. [DVB Executive # 1] is the president of DaVinci and DVB.
3. [DVB Executives # 2 and 3] are founding members and officers of DaVinci and
DVB.
Human Fetal Tissue Repository
1. [Einstein Executive Dean] is a senior official at the Albert Einstein College of
Medicine.
2. [Einstein Vice-President, Government and Community Relations] is an official who
handles government relations at the Albert Einstein College of Medicine.
3. [Einstein Vice-President, External Affairs] is an official who handles external
relations at the Albert Einstein College of Medicine.
A. StemExpress, LLC: A Case Study
1. Summary
The Panel conducted an investigation of StemExpress, LLC (StemExpress) that uncovered
evidence that StemExpress may have violated 18 1519, 42 289g-2, the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), provisions of the California Health and
Safety Law, the California Tax Revenue and Tax Code, and regulations promulgated by the U.S.
Department of Health and Human Services (HHS).
a) Background of StemExpress
StemExpress was founded as a for-profit corporation with the California Secretary of
State on March 4, 2010, by [the Founder and CEO].131 On December 2, 2015, [the Founder &
CEO] filed papers with the California Secretary of State that created the StemExpress
Foundation, which is located at the same address as StemExpress.132 It is unclear whether the
Foundation is for-profit or non-profit, because its tax forms are not yet publicly available.
Before [the Founder and CEO] began StemExpress, she worked for Advanced Bioscience
Resources, Inc. (ABR) another tissue procurement company that is established as a non-profit.133
131

California Secretary of State, Business Entity Detail, http://kepler.sos.ca.gov.

Id.
133
For more details on ABR, see subsection B below.
132

137

ABR executives express a low opinion of the Founder & CEO. On an unedited Center for
Medical Progress (CMP) videotape viewed by Panel Staff, [ABRs procurement manager] stated
that [the Founder and CEO] . . . is totally unethical, she worked for us, she went into our office
one night, looked around, and took everything we had, and started her own business, and quit the
next day. I will tell you that.134
The U.S. Food and Drug Administration (FDA) had planned in 2014 to conduct an
inspection of StemExpress based on the FDAs priorities list.135 The FDA only has jurisdiction
over fetal tissue that is intended for transplantation into human subjects. The inspection was
dropped after an FDA consumer safety officer determined that StemExpress:
. . . essentially collected blood and tissue products including stem
cells, whole blood, leukocytes, etc . . . from a human donor. . . . The
company advertises for, collects from (on-site), and maintains, [a]
potential donor database . . . . Their products are not intended for
transplant, implant or transfer into a human recipient.136
The FDA consumer safety officer stated: I plan to tell StemExpress that they do not have
to register as a human tissue establishment [and thus are not under FDA jurisdiction] because
they do not sell [a] product that is intended for transfer into a human recipient.137
b) History of the Panels Interactions with StemExpress
On December 17, 2015, the Panel sent StemExpress a document request letter that
requested a list of all entities from which it procured fetal tissue, a list of all entities to which it
sold or donated fetal tissue, an organization chart, all communications that direct its employees
to procure fetal tissue, a list of all federal funds the firm received, accounting records, and all
StemExpress banking records related to the procurement, sale, donation, distribution or shipment
of fetal tissue.138
StemExpress only produced the names of abortion clinics to the Panel from which it had
procured fetal tissue that also had been previously produced to investigations into the fetal tissue
industry conducted by the Senate Committee on the Judiciary and the House Committee on
Energy and Commerce.139 StemExpress refused to produce voluntarily the names of all of the
clinics from which it procured fetal tissue.140 Due to this lack of cooperation, on February 12,
2016, the Panel issued a subpoena to StemExpress. The subpoena demanded copies of the

134

Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNND0569_ 20140406173620.
135
Email from [Consumer Safety Officer # 1], U.S. Food and Drug Administration, to [Consumer Safety Officer #
2], U.S. Food and Drug Administration (Aug. 15, 2014).
136
Id. (emphasis in original).
137
Id.
138
Letter from Rep. Marsha Blackburn, Chairman, House Select Investigative Panel, to [Founder and CEO,
StemExpress, LLC] (Dec. 17, 2015), Exhibit 5.1.1
139
StemExpress Second Response to Senate Judiciary Committee. [STEM.JUD00000024; STEM.HOUSE SELECT
0057] Exhibit 5.1.
140
StemExpress First Response to House Select Panel Document Requests (Jan. 15, 2016) Exhibit 5.2.

138

documents first requested in the December 17, 2015 letter, including the communications with
its employees, accounting documents, and all banking records.141
StemExpress produced communications to the Panel that spanned only two years instead
of the five required by the subpoena, and these were so replete with redactions as to render them
unusable.142 StemExpress produced only roll-up accounting summaries, not the required
primary source accounting records.143 To date, the Panel has not received a single accounting
record from StemExpress.
The Panel, in a February 12, 2016, subpoena to StemExpress (which is discussed below),
requested all communications and documents that identify any federal, state, or local government
funds that StemExpress received either directly or indirectly.144 StemExpress responded that it
had nothing responsive to produce. (StemExpress has confirmed that there are no
communications or documents responsive to this . . . .)145 Despite that representation, the Panel
discovered that StemExpress received more than $9,000 in a small business loan from the U.S.
Small Business Administration.146
StemExpress refused to produce any of its banking records as required by the subpoena.
However, in a production from another entity, the Panel discovered the name of StemExpress
bank and its account number and issued a subpoena to that bank.147 Due to StemExpress refusal
to comply with repeated subpoenas, on September 21, 2016, the Panel unanimously
recommended that the House of Representatives hold StemExpress in contempt of Congress (for
more details on this, see subsection 7: The Select Panel Recommends that the House Find
StemExpress in Contempt of Congress).148
As Rep. Duffy (WI-7) noted during the meeting at which the contempt recommendation
was voted:
This committee nine months ago sent out a request for documents to
StemExpress. And they failed to comply completely with that
subpoena. Now, we have sent other subpoenas to tissue procurement
businesses and they have complied. They had no problem sharing
their information with this committee. But StemExpress, however,
failed to fully comply. And we are not talking about really sensitive
information. We are talking about their banking records, their
accounting records. That is what we have asked for. What is in the
141

Subpoena to StemExpress, LLP, (Feb. 12, 2016), Exhibit 5.3.

StemExpress, Third Response to House Select Investigative Panel Subpoena (Apr. 11, 2016)
[STEM.HOUSE.SELECT0064 STEM.HOUSE.SELECT_0670], Exhibit 5.4.
143
See Letter from Amandeep S. Sidhu, McDermott Will & Emery, to T. March Bell, Chief Counsel and Staff
Director, House Select Investigative Panel 1 (Mar. 18, 2016) (emphasis in original); See Letter from Amandeep S.
Sidhu, McDermott Will & Emery, to Rep. Blackburn, Chairman, House Select Investigative Panel 2 (May 6, 2016).
144
Subpoena to StemExpress, Exhibit 5.3.
145
Id., Exhibit 5.3
146
See Center for Effective Government website, www.FedSpending.org.
147
See Subpoena to Five Star Bancorp (Apr. 29, 2016).
148
See Select Investigative Panel of the H. Comm. on Energy and Commerce, Business Meeting, unedited transcript
(Sept. 21, 2016).
142

139

banking and accounting records that is so secretive that they wont

comply with a congressional lawful subpoena? That is the question
that we have to ask ourselves. What don't they want us to know?149
The Panel had reason to ask the questions posed by Rep. Duffy. An examination by Panel
staff of StemExpress bank records found payments to Shred-It USA that, for the most part,
corresponded with dates of document demand letters from congressional investigations of the
fetal tissue industry, subpoenas from the Panel, and StemExpress productions to the Panel and
other congressional inquiries. StemExpress bank records dating back to November 2012 revealed
there were no payments made to Shred-It USA prior to the first congressional investigations into
the fetal tissue industry.150 The chart below shows those payments:
Congressional
Action

Payment to
Shred-It-USA

StemExpress Action

July 16, 2015

Senate Judiciary
Committee
document request

August 13, 2015

August 19, 2015 StemExpress production to Senate Judiciary

Committee

August 7, 2015
Energy &
Commerce
Committee
document request

August 13, 2015

August 21, 2015 StemExpress production to Energy &

Commerce Committee

August 25, 2015

Energy &
Commerce
Committee
document request

August 25, 2015

September 11, 2015 StemExpress production to Energy &

Commerce Committee in response to questions from briefing

September 9,
2015 Oversight
& Government
Reform
Committee
document request

September 29,
2015

October 9, 2015 StemExpress production to Oversight &

Government Reform Committee

September 17,
2015 Senate
Judiciary

September 24, 2015 StemExpress production to Senate

Judiciary Committee

149

Id. at 27.
Panel staff analysis of StemExpress, LLC, payments to Shred-It-USA drawn from documents produced by Five
Star Bancorp to the Panel.
150

140

Committee
document request
letter
December 17,
2015 Select
Investigative
Panel document
request

February 12, 2016

Select
Investigative
Panel subpoena

January 12, 2016

January 15, 206 StemExpress production to Select

Investigative Panel

January 27, 2016

February 1, 2016 StemExpress production to Select

Investigative Panel

March 12, 2016

March 28, 2016 StemExpress production to the Select

Investigative Panel

April 26, 2016

May 10, 2016 StemExpress production to Select Investigative

Panel

2. StemExpress Business Model

StemExpress business model was to obtain fresh fetal tissue from a large number of
abortion clinics and provide on-demand fetal tissue to researchers around the world. In order to
do that, the firm needed a ready supply of fetal tissue. The only way to achieve that was to
dramatically increase the number of abortion clinics from which it obtained fetal tissue. In order
to provide fetal tissue to the largest number of customers, StemExpress had to increase the
number of abortion clinics from which it procured fetal tissue. A profile of [the Founder and
CEO] published in July 2015, noted: [StemExpress was] opening a branch in Washington, D.C.,
in the next three months and is looking at the possibility of a site in Europe as well.151
The Panel notes that StemExpress entry into the tissue procurement business coincided
with an increase in federal government grants for research using fetal tissue. The average amount
of time for a researcher to obtain a grant for fetal tissue research from the National Institutes of
Health (NIH) is three years. The Panel reviewed all grants that involved fetal tissue (see Chapter
IX). That review found the number of grants using fetal tissue declined from fiscal years 2009
through 2012, but, starting in fiscal year 2013, there was an upsurge.
a) Marketing Activities
StemExpress recruited and screened abortion clinics from which it could procure saleable
tissue for researchers.152 The company sought information about the number of abortions the
2015 Women Who Mean Business: [Founder and CEO and StemExpress] founder and CEO, Stem Express
[sic], Sacramento Business Journal, June 19, 2015.
152
StemExpress Website Recruitment Form for Abortion Clinics. See following page.
151

141

clinics performed each week, the gestational ages of fetuses scheduled to be aborted, the days the
abortions were done, whether digoxin153 was used (which would taint the tissue and thus render
the tissue useless for research), and, if so, at what gestation digoxin was used. A copy of the
Website Recruitment Form for abortion clinics follows:

153

Digoxin is a heart medication that sometimes is injected into the amniotic fluid or fetus to cause fetal demise
before surgical or induction abortion. See Abortion in California: A Medical-Legal Resource,
http://californiaabortionlaw.com/wp/?page_id=135.

142

The firm developed an aggressive marketing strategy directed toward abortion clinics.
StemExpress had booths at both the 2014 and 2015 annual meetings of the National Abortion
Federation (NAF). StemExpress was a silver-level sponsor at the NAF meeting: StemExpress
paid NAF $5,000 for that status in 2014 and $10,000 in 2015.154 StemExpress had a half-page
advertisement in the program for both the 2014 and 2015 NAF meetings.155 At the conferences,
StemExpress distributed a brochure to NAF members that promised abortion clinics they would
be [f]inancially profitable if they allowed StemExpress to procure tissue from the clinics. The
brochure stated: By partnering with StemExpress the clinics will not only help research but
[they] will also be contributing to the fiscal growth of [their] own clinic[s].156 The full brochure
and the two half-page ads follow.

154

Email from name redacted, Vice President, Corporate Development, StemExpress, LLC, to name redacted,
Subject: Partnership Agreement StemExpress (Mar. 25, 2015) [NAF-000045]; Partnership Agreement between
StemExpress, LLC, and the National Abortion Federation (Mar. 25, 2015) [NAF-000046 NAF-000053], Exhibit
5.5.
155
NAF 2014 and 2015 advertisements. See Exhibit 5.1.9.
156
StemExpress, LLC, brochure distributed at National Abortion Federation Meeting, undated [NAF-000001
NAF-000004]. NAF produced to the Panel a black-and-white version of the brochure. A color copy that is identical,
with the exception of a StemExpress employees business card, that the Panel found on the Internet is reprinted in
the Report.

143

144

145

NAF 2014 Conference

146

NAF 2015 Conference

147

b) StemExpress Seeks a Nationwide Network of Abortion Clinics

During the timeframe of StemExpress conference marketing scheme, it sought a
contractual relationship with NAF, a national association of independent abortion clinics.
Documents produced by NAF to the Panel reveal that, for at least a year, StemExpress and NAF
actively negotiated a Group Purchasing contract. This effort revealed StemExpress strategy to
increase the number of abortion clinics from which it obtained fetal tissue, thereby enabling
StemExpress to both promise customers a quick response and achieve higher revenues.
The Panel sought to understand the proposed NAF-StemExpress relationship. The
proposed partnership agreement raises questions of whether StemExpress and NAF both saw the
proposed contract as a means to increase their respective revenue streams.
An email NAF produced to the Panel shows that the negotiations with StemExpress date
back to at least February 2014. On February 20, 2014, NAFs Group Purchasing Manager sent an
email that stated:
I spoke with [name redacted] from Stem Express [sic] today
regarding them becoming a Group Purchasing vendor in the
program. As [name redacted] and I discussed yesterday theirs is a
unique service that would not fall under the 3% administrative fee
realm. From my conversation today I feel it is even more unique
than I initially anticipated.
Here is a summarization of the process as [named redacted]
described it:
1. Stem Express collects the maternal blood from the patient and/or
the fetal tissue after the procedure.
2. Either a Stem Express employee located at the clinic or a clinic
employee gathers and stores the collection.
3. The collection (product) is sent to the lab and cells are isolated for
research.
4. The participating clinic is paid by Stem Express a fee per
collection.
The fact that Stem Express is the payer and our member is the payee
changes the fee structure. Perhaps we can access a fee or value for
each member that participates or base it on financial payouts to the
member. For instance, when a member is paid up to $500, Stem Cell
[sic] would owe X amount to NAF or a flat yearly fee based on the
number of participating members.

148

I know the final decision would be [name redacted]s regarding

payment terms however I wanted to have a concrete suggestion to
put forth. What are your thoughts?157
An unidentified person at NAF responded on February 20, 2014: I like the idea of
setting benchmarks and NAF getting fees based on usage.158 StemExpress and NAF actively
and repeatedly discussed the proposed draft contract in email exchanges.
In August 2014, StemExpress accounting manager told a person within the company
whose name was redacted: This [proposed contract with NAF] looks like it aligns better with
us.159 On October 24, 2014, an unknown person at NAF emailed StemExpress: Just checking
in to see how the vendor agreement is coming.160 In January 2015, [the Founder and CEO] sent
an email to an unidentified person at NAF in which she explained that the StemExpress official
charged with negotiating the NAF agreement is no longer with the company and I wanted to
make sure the vendor agreement doesnt get put on back burner so could you please resend this
agreement and we will get it turned around to you.161 An unidentified person at NAF responded:
Well that explains her lack of response. I am glad you are still
interested.
I have attached an initial draft of an agreement. As I explained to
[name redacted] this is unique as it is not a product therefore the
standard admin[istrative] fee process does not apply.
Please review the attached and fill in the blanks. Let me know if we
need to [set up] a call to discuss.
On another note, we are gearing up for our Annual Meeting in
Baltimore. I will have a prospectus in the next week or so.162
On January 15, 2015, [the Founder and CEO] sent an email to NAF in which she stated:
Attached is the draft agreement with marked up comments. It might
be best to set up a conference call next week to discuss this in further
detail as a lot of this agreement had language in it that looked like it
was for a professional liability insurance company, which we clearly

157

Email from Group Purchasing Manager, National Abortion Federation, to [redacted], Subject: RE: Stem Express
[sic] GP Vendor (Feb. 20, 2014) [NAF-000016] (spacing in original), Exhibit 5.6.
158
Email from [redacted] to [redacted], Subject: RE: Stem Express [sic] GP Vendor (Feb. 20, 2014) [NAF-000016],
Exhibit 5.6.
159
Email from [redacted], Accounting Department Manager, StemExpress, LLC, to [redacted], StemExpress, LLC,
Subject: RE: NAF GP membership (Aug. 8, 2014) [NAF-000034], Exhibit 5.7.
160
Email from [redacted], National Abortion Federation, to [redacted], StemExpress, LLC, Subject: RE: NAF GP
membership (Oct. 24, 2014) [NAF-000034], Exhibit 5.7.
161
Email from [redacted], CEO and Founder, StemExpress, LLC, to [redacted], Subject: RE: NAF GP membership
(Jan. 6, 2015) [NAF-000033], Exhibit 5.8.
162
Email from [redacted], National Abortion Federation, to [redacted] (Jan. 8, 2015) [NAF-000033], Exhibit 5.8.

149

arent, so I just wanted to make sure that we were on the same page
about what should be included in this agreement.163
On February 18, 2015, [the Founder and CEO] wrote NAF: I havent forgotten to send
this I have just been buried . . . I have been in the process of updating a few contracts here at the
beginning of the year. The clinic contract is one of them. We should have it to you in the next
two weeks.164 NAF replied on February 27, 2015, I have attached a revised agreement. Please
submit any changes and contact me with any questions.165
In March 2015, StemExpress vice president for corporate development sent NAF the
firms revised version of the partnership agreement:
Please find a draft Partnership Agreement for your consideration.
Ive taken the liberty of reformatting a bit of it to follow our moreroutine contract structure (no real change to the substantive
contract). I removed the language pertaining to alternative donations
($5K and $10K) since we elected to go with $10K and participate in
the upcoming NAF meeting . . . There will appear to be a lot of
redlining in the Appendix, but this is largely an artifact of changing
the content to reflect StemExpress business . . .
If the agreement with changes are acceptable to you, please accept
changes, sign and return to me at your earliest convenience. If you
need to make changes, please reply with your redline as soon as
possible and Ill get the document turned around promptly.166
Below are excerpts of the March 25, 2015, draft partnership agreement between
StemExpress and NAF:
Services and Donation:
(a) NAF commits to performing the services outlined in this document
under Appendix A.
(b) StemExpress agrees to make a donation to the NAF in the amount
of US $10,000 and undertake the activities listed in Appendix B . . .

163

Email from [redacted], CEO and Founder, StemExpress, LLC, to [redacted], Subject: RE: NAF GP membership
(Jan. 15, 2015) [NAF-000023]; Purchase Agreement between NAF and StemExpress, LLC (Jan. 10, 2015) [NAF000024 NAF-000032], Exhibit 5.9.
164
Email from [redacted], CEO and Founder, StemExpress, LLC, to [redacted], Subject: FWD: NAF GP
membership (Feb. 18, 2015) [NAF-000036], Exhibit 5.10.
165
Email from [redacted], to [redacted], StemExpress, LLC, Subject: RE: NAF revised agreement (Feb. 27, 2015).
[NAF-000036]; Partnership Agreement between the National Abortion Federation and Stem Express [sic], undated
[NAF-000037 NAF-000044], Exhibit 5.10.
166
Email from [redacted], Vice President, Corporate Development, StemExpress, LLC, to [redacted], Subject:
Partnership Agreement StemExpress (Mar. 25, 2015). [NAF-000045]; Partnership Agreement between
StemExpress, LLC, and the National Abortion Federation (Mar. 25, 2015) [NAF-000046 NAF-000053], Exhibit
5.11.

150

Appendix A
NAFs Commitment
For the aforementioned sum mentioned in the section marked
Payment for Services, NAF commits to performing the following
for one year to assist StemExpress in presenting its collection
program to NAF members:
Create and disseminate to NAF members correspondence from
NAFs Group Purchasing Manager about StemExpress and the
collection program twice yearly at the request of StemExpress.
. . . Provide a cover letter for NAFs President and CEO pertaining
to the StemExpress collection program which StemExpress can use
to accompany marketing materials for NAF members.
. . . Provide mailing list for StemExpress to send out marketing
materials to NAF members regarding the background of
StemExpress, its collection program, and benefits of member
participation in the program.
Provide assistance to StemExpress in gathering testimonials from
existing program participants from among NAF members.
. . . Supply StemExpress with a quarterly updated list of members.
Appendix B
StemExpress Commitment
StemExpress commits to performing the following for one year to
market its collection services to NAF members:
. . . Create and produce marketing slicks on the background of
StemExpress, its capabilities, and highlight participation benefits.
Provide, at no charge to NAF, informative sessions or meetings that
present the collection program.
Develop client success stories on how StemExpress brought a value
added service to participating members. This will help to inform
members about StemExpress offerings.
Commit to attending NAFs Annual Meeting in April of each year.
Pursue all leads from NAF, introducing StemExpress and what
StemExpress capabilities are.167

167

See StemExpress, Third Response to House Select Investigative Panel Subpoena (Apr. 11, 2016)
[STEM.HOUSE.SELECT0064 STEM.HOUSE.SELECT_0670], Exhibit 5.4.

151

In April 2015, NAF replied:

My apologies as my promise to respond by COB today comes with
a delay. There is cause for concern regarding the added text under
the Assignment section. It denotes, StemExpress may assign this
Agreement to an acquirer without notice . . . pursuant to an
acquisition or merger of StemExpress involving greater than 50% of
the company, provided further, that any respective successor or
permitted assign shall thereby assume all of such StemExpress
rights, and shall be subject to all of such StemExpress duties and
obligations, hereunder.
That clause takes away a discretion that is essential to the prescreen
process and creates [a] privacy concern that we go to great lengths
to protect. Although I agree there is no other changes that impact the
substantive content, [name redacted], our general counsel, is giving
it a quick read. I did think however that in the interest of time, you
could respond to the deletion request noted above.168
NAF produced no further communications about its proposed partnership agreement with
StemExpress. However, NAFs counsel told Panel staff that, during the timeframe when the
Center for Medical Progress videos were made public, the organizations leadership had
significant concerns about being involved with a tissue procurement business.
The Panel determined that StemExpress brochure aimed at abortion clinics nationwide,
and its attempted partnership agreement with NAF belies StemExpress contention that it was
losing money. Rather, those facts show StemExpress had a business model based on expansion
of its market share.
c) StemExpress Seeks Partnership Agreement with Planned Parenthood Federation of
America
Just as StemExpress sought a relationship with NAF, it also sought a contract with
Planned Parenthood Federation of America (PPFA) and its affiliates. If the proposed
relationships with PPFA and NAF had been successful, StemExpress would have had access to
virtually every abortion clinic in the nation. [PP Witness #1] stated:
So, we tried to do this, and at the national office we have a Litigation
and Law Department that just really doesnt want us to be the middle
people for this issue, right now. Because we were actually
approached by StemExpress to do the same thing. One of the
California affiliates said, Were working with these people, we
love it, we think every affiliate should work with them. And so we
had a conversation, and we said, you know, what if we go out and
168

Email from [redacted], National Abortion Federation, to [redacted], StemExpress, LLC, (Apr. 9, 2015) [NAF00063], Exhibit 5.11.

152

find everyone who is doing this and present everybody with a menu,
and at the end of the day they just decided that right now, its just
too touchy an issue for us to be an official middleman.169
In a conversation with a CMP journalist, [PPFA Witness #3] confirmed that one of the
major reasons that held PPFA back from a partnership agreement with a tissue procurement
organization was because we have [the] potential for a huge PR issue on doing this.170 Despite
PPFAs hesitancy due to public relations, StemExpress already had contracts with a number of
PPFA affiliates.
d) StemExpress Contracts with Abortion Clinics
StemExpress had contracts to procure fetal tissue from the following PPFA affiliates:

Planned Parenthood Mar Monte (PPMM)

Planned Parenthood Shasta Pacific (PPSP); and
Planned Parenthood of Santa Barbara, Ventura & San Luis Obispo Counties (PPSB).171

StemExpress also had contracts with the following five independent abortion clinics:

Camelback Family Planning (CFP)

Cedar River Clinics (CRC)
Presidential Womens Center (PWC)
Womens Health Specialists (WHS)
Family Specialists Medical Group (FPS)
Little Rock Family Planning Services (LRFPS).172

Documents show that StemExpress never procured fetal tissue from Planned Parenthood
San Bernardino, Womens Health Specialists, or Little Rock Family Planning Services.173
169

Center for Medical Progress, Transcript of Meeting with [PP Witness #1] 28-29 (July 25, 2014).
Center for Medical Progress video FNND0569_ 20150226165708 (Feb. 26, 2015) produced to the Committee on
Oversight and Government Reform.
171
Exhibit 5.4; Services Agreement between StemExpress, LLC, and Planned Parenthood Mar Monte (Apr. 1, 2010)
[STEM.HOUSE.SELECT_0167 STEM.HOUSE.SELECT_0189], Services Agreement between StemExpress,
LLC, and Planned Parenthood Shasta Pacific (May 5, 2012) [STEM.HOUSE.SELECT_0170
STEM.HOUSE.SELECT_0172], Services Agreement between StemExpress, LLC, and Planned Parenthood of Santa
Barbara, Ventura & San Luis Obispo Counties (Oct. 23, 2013) [STEM.HOUSE.SELECT_0181
STEM.HOUSE.SELECT_0183], Exhibit 5.12.
172
StemExpress, LLC, produced to the Panel invoices covering numerous years from Planned Parenthood Mar
Monte, and Planned Parenthood Shasta Pacific. Camelback Family Planning, Cedar River Clinics, Presidential
Womens Center, and Family Specialists Medical Group produced to the Panel invoices to StemExpress, LLC. See
Letter from Mark Merin, counsel to Womens Health Specialists, to Panel staff 2-3 (Apr. 11, 2016); Letter from
Bettina E. Brownstein, counsel for Little Rock Family Planning Services 1 (Oct. 10, 2016).
173
Services Agreement between StemExpress, LLC, and Camelback Family Planning, undated [CFP000002
CFP000006], Services Agreement between StemExpress, LLC, and Cedar River Clinics (Nov. 15, 2013) [CRC001
CRC 006], Services Agreement between StemExpress, LLC, and Presidential Womens Center (Feb. 14, 2014)
[PWC-0001 PWC0003], Exhibit 5.13; Letter from Mark Merin, counsel to Womens Health Specialists, to Panel
staff (Apr. 11, 2016); Letter from Bettina E. Brownstein, counsel for Little Rock Family Planning Services 1 (Oct.
10, 2016)
170

153

Under the terms of its contracts:

StemExpress paid Planned Parenthood Mar Monte $55 for each fetal tissue specimen and
$10 for each maternal blood sample.174

StemExpress paid Planned Parenthood Shasta Pacific $55 for each fetal tissue specimen
and $10 for each maternal blood sample.175

StemExpress had a two-tier payment plan with Planned Parenthood San Bernardino: $75
for fetal tissue samples and $50 for maternal blood, if it was collected solely by
Planned Parenthood San Bernardino staff; if StemExpress staff collected the samples,
then there would be a cost adjustment . . .176

StemExpress paid Camelback Family Planning $200 for 5cc or more of liver tissue and
three tubes of maternal blood; $250 for 5cc of liver and thymus of the same fetus and
three tubes of maternal blood; and $75 for other fetal tissue as requested by
StemExpress with three tubes of maternal blood.177

StemExpress paid Cedar River Clinics $50 for maternal blood; $75 for each fetal tissue
specimen; $125 for fetal tissue with an IDS blood sample; $125 for maternal blood and
tissue kits; between $100 - $400 for fetal blood samples; $50 for blood; $75 for each fetal
tissue specimen; and face value ($25) for gift cards distributed to blood donors, if
Cedar River Clinics staff collected the blood and tissue.178

StemExpress paid Presidential Womens Center $50 per 60cc of maternal blood, and $75
for each fetal tissue specimen, if collected solely by clinic staff:179 If StemExpress staff
is onsite to physically collect the sample, then there would be a cost adjustment for the
collection of the sample.180 StemExpress paid Family Specialists Medical Group $55 for
each tissue sample, and $10 for maternal blood.181

Exhibit 5.12. H. Res. 461 did not mention maternal blood; thus, the Panel did not examine StemExpress role in
the procurement or sales of maternal blood. StemExpress practices when it came to the procurement and sale of
maternal blood are indicative of its profit-driven business model, and will be discussed in the Revenue Growth
section below.
175
Id.
176
Id.
177
Services Agreement between StemExpress, LLC, and Camelback Family Planning, undated [CFP000002
CFP000006], Exhibit 5.13.
178
Services Agreement between StemExpress, LLC, and Cedar River Clinics (Nov. 15, 2013) [CRC001 CRC 006],
Exhibit 5.13.
179
Services Agreement between StemExpress, LLC, and Presidential Womens Center (Feb. 14, 2014) [PWC-0001
PWC0003], Exhibit 5.13.
180
Id.
181
Id.
174

154

StemExpress paid Womens Health Specialists $50 per 60 ccs of maternal blood and $75
for the collection of fetal tissue, including each tissue organ/component (e.g., 1 heart, 1
liver, 1 brain = 3 component[]s X $75 each = $225) . . .182
e) Impact of StemExpress Contracts on Clinical Practices

The Panel sought to determine whether the clinics changed their clinical practices in
order to increase the amount of tissue samples StemExpress could obtain and thereby generate
more revenue to the clinics. Through its review of the unedited CMP videotapes, the Panel
learned that Cedar River Clinics (CRC), by its own admission, changed its clinical practices.
[Clinic Executive #1] had the following exchange with a CMP journalist:
CMP Journalist: [C]ould we just get a certain number of liver from
you.
[Clinic Executive #1]: Livers a big thing right now. We just actually
increased our gestation for dig[oxin], so that we could be able to get
more liver, bigger liver.183
[PP Witness #1] testified that she changed abortion procedures to procure specific
orders for fetal tissue (see Chapter VIII). [PP Witness #1] made similar statements on a
Center for Medical Progress videotape.
3. StemExpress Revenue Grows from $156,312 to $4.5 Million
Between 2010 and 2014, StemExpress experienced tremendous revenue growth. In 2010,
its revenue was $156,312. During 2011, that figure more than doubled to $380,000, and a year
later, in 2012, StemExpress revenue nearly tripled to $910,000. By 2013, its revenue was $2.20
million, and in 2014, the revenue had once again more than doubled to $4.50 million.

Letter from Mark Merin, counsel to Womens Health Specialists, to Panel staff (Apr. 11, 2016), Exhibit 5.13.
Center for Medical Progress videotape FNND0569_20140407161401 (Apr. 7, 2014) produced to the Committee
on Oversight and Government Reform.
182
183

155

A profile of [the Founder and CEO] noted:

She started StemExpress with just $9,000, running the business out
of her Placerville home. She quickly found that there was indeed a
demand for the company's products. Several new clients contacted
her each week, without any active marketing, as word about
StemExpress spread along the scientific grapevine.
The company ranked No. 363 [in 2014] on the lnc. 500 list of fastest
growing private companies, with 1,315 percent growth over three
years and revenue of $2.2 million in 2013, and it ranked No. 35 on
lnc.s list of the fastest growing women-led companies in the
country.184
The Panel sought to determine an accurate picture of StemExpress revenues and costs
associated with fetal tissue procurement. StemExpress presented conflicting accounts. For
2015 Women Who Mean Business: [Redacted], founder and CEO, StemExpress, Sacramento Business Journal,
June 19, 2015.
184

156

example, [the Founder and CEO] stated to the Committee on Energy and Commerce:
StemExpress believes that it is losing money [on fetal tissue].185 StemExpress produced a list
to the Panel of its estimated costs and expenses associated with fetal tissue procurement which
purported to show that StemExpress lost money on fetal tissue.186 StemExpress counsel
represented that the reports were generated by StemExpress personnel directly from the
companys accounting and software systems.187 When she was asked to document
StemExpress costs to obtain fetal tissue, [the Founder and CEO] stated that StemExpress
doesnt have a spreadsheet or matrix for all of its costs, and acknowledged that the firms
estimated costs and expenses were produced by the firms lawyers.188 These conflicting
statements redoubled the Panels efforts to obtain accounting records.
a) StemExpress Estimated Costs and Expenses Indicates That It May Have Made a
Profit
A comparison of invoices, attorney-created accounting documents, and productions from
multiple StemExpress customers shows that the firm may have made a profit when procuring and
transferring fetal tissue. The Panels cost analysis shows StemExpress overstated some of its
labor costs, and claimed shipping, supplies, and infectious disease screenings as expenses. These
costs were charged to researchers and thus cannot be costs that StemExpress can count against its
revenue. StemExpress has consistently refused to produce subpoenaed accounting documents
that the Panel requires to complete its analysis.
Attorneys for StemExpress created several cost estimates (orange numbers) that purport
to show that StemExpress loses money each time it procures a fetal tissue sample and ships it to
a customer. Shown in orange, the cost estimates produced by the attorneys are inconsistent with
accounting records produced by StemExpress itself. For example, the Panel determined there
was a discrepancy among the firms cost items, StemExpress contracts with the abortion clinics
at which it procured fetal tissue, and invoices from abortion clinics to StemExpress. The firm
contended that $55 for clinic reimbursement consisted of technician space, storage of supplies,
blood draw chair usage, and consent space. Both the contracts with the abortion clinics and the
invoices from the abortion clinics to StemExpress show the firm paid $55 per fetal tissue sample.
In another example, the management labor costs at one hour per item ordered, which are counted
twice, are dramatically inconsistent with the number of orders actually handled by StemExpress.
Similarly, StemExpress estimates do not allocate any costs (such as mileage) to maternal blood
which is harvested at the abortion clinic at the same time the human fetal tissue is harvested.

185

StemExpress Briefing Notes, Committee on Energy and Commerce (Aug. 25, 2015), Exhibit 5.14.
StemExpress, LLC, StemExpress Estimated Costs and Expenses Associated with Fetal Tissue Procurement
(2011-2016) (May 10, 2016) [STEM.HOUSE.SELECT_0915], Exhibit 5.15.
187
StemExpress, LLC, StemExpress Sixth Response to House Select Panel Subpoenas (May 10, 2016)
[STEMHOUSE.SELECT_0908], Exhibit 5.16.
188
StemExpress Briefing Notes, Exhibit 5.14.
186

157

COMPARISON OF STEMEXPRESS COST ANALYSIS WITH GENERALLY ACCEPTED

INDUSTRY STANDARDS FOR ONE UNIT OF FETAL TISSUE IN 2013

COST ITEMS AND ESTIMATE PRODUCED BY STEMEXPRESS

ADJUSTED BASED ON REASONABLE INDUSTRY STANDARDS
COSTS ALLOCATED TO MATERNAL BLOOD ESTIMATED AT 50%

Cost Item

Description

Estimated
Time

Estimated
Cost/Expense

Recalculated
Time

Recalculated
Cost/
Expenses

Costs
for
Maternal
Blood

Procurement
Management
Labor

Receive and evaluate purchase

order, enter into Computer
system and task board, assign
to clinics.

1 hour x
$35

$25.00

.5 hour x $35

$12.50

$ 6.25

Packaging
Supplies Labor

Packaging all supplies needed

for procurement.

1 hour x
$10

$10.00

.5 hour x $10

$5.00

$2.50

Shipping

Supplies to Clinic

N/A

$15.00

$15.00

$7.00

Mileage

Mileage paid to technician

(.56/mile)

N/A

$75.00

$75.00

$35.00

Supply cost

Box, conical tube, media, petri

dish, labels, biohazard bag, gel
packs, etc.

N/A

$30.00

$30.00

$15.00

Technician Base
Labor

Patient consent, procurement,

paperwork packaging.

8 hour x
$10

$80.00

$10.00

$5.00

Technician
Supplemental
Compensation

Technician Supplemental
Compensation

N/A

$30.00

$0.00

$0.00

Clinic
Reimbursement

Technician space, storage of

supplies, blood draw chair
usage, consent space

N/A

$55.00

$55.00

$27.50

Infectious Disease
Draw

Supplies: tubes, labels, needle,

biohazard bag, etc.

N/A

$15.00

$15.00

$7.50

Infectious Disease
Screening

Screening for HIV, HepB,

HepC, LCMV

N/A

$70.00

$70.00

$35.00

158

1 hour x $10

Shipping

Average Shipment cost to the

Lab (blood and/or tissue)

N/A

$20.00

$20.00

$10.00

Procurement
Management
Labor

Review paperwork,
communications with courier,
communications with
researcher

1 hour x
$35

$35.00

$35.00

$5.00

Product Receipt

Receipt of product at front

desk, check into Sage, check
into log

1 hour x
$15

$15.00

.25 hour x
$15

$4.00

$2.00

Inventory &
Supply
Management

Prorated stores management

1 hour x
$20

$20.00

.25 hour x
$20

$5.00

$2.50

$351.50

175.75

$495.00

Sample review of a sale of maternal

blood to customer Baylor per invoice
#1940 of 1/12/2013

Sample review of a sale of fetal tissue

to customer Baylor per invoice #1940
of 1/12/2013

Sale price for Tissue $250.00

Sale price for Tissue $250.00

Disease screening charged to client

$125.00

Disease screening charged to client

$125.00

Shipping charged to client $85.00

Shipping charged to client $85.00

Total Revenue obtained from this sale

$460.00

Total Revenue obtained from this sale

$460.00

Estimated cost of Tissue (per above)

$175.75

Estimated cost of Tissue (per above)

$351.00

Excess of revenue over cost $217.00

159

Excess of revenue over cost $108.50

b) StemExpress Used Deceptive Trade Practices to Obtain Maternal Blood at Zero Cost
The Panels investigation revealed that, while StemExpress paid market prices for maternal
blood in some settings, it obtained blood from abortion clinic patients without payment to the
women.
While blood donations and sales are not covered by 42 U.S.C. 289g-2, StemExpress
procurement and sales of maternal blood is indicative of how profit drove the company.
StemExpress paid abortion clinics between $10 and $75 for maternal blood. StemExpress paid
nothing to the blood donors at the clinics, with the sole exception of Cedar River Clinics, where
it provided $25 gift cards to patients who donated blood. Outside of abortion clinics, however,
StemExpress directly paid donors. The Panel obtained a photograph that demonstrates that
StemExpress offered women the opportunity to Donate your blood and Get $25.189 The
photograph of a company booth, has a sign on it which states: Need Cash: $25 . . . per [blood]
donation . . .190 For example, a brochure that sought blood donations produced by StemExpress
to the Panel shows that the firm paid women outside of abortion clinics: All of our donors
receive a gift card for their donation ranging from $25-$250. . . . In 2014 StemExpress gave out
over $140,000 in gift cards to donors . . .191
StemExpress website shows it sold (and continues to do so) maternal blood for between
$340 and $510;192 peripheral blood for between $115 and $2,464;193 and umbilical cord blood for
between $76 and $10,885.194 StemExpress collection of blood shows that the firms focus is on
profits, not on informing patients in abortion clinics who donate their blood that they have the
opportunity to be paid for their blood elsewhere.
The Panel sought to determine the attitude of StemExpress contractors, PPFA and its
affiliates, toward StemExpress practice of how it obtained blood. The PPFA executive
responsible for the organizations medical guidelines and practices was asked repeatedly by the
Panel whether she was troubled by StemExpress remuneration for womens blood outside of
abortion clinics, while it paid nothing for the blood of vulnerable women who were about to
undergo an abortion. Despite repeated questions, the senior PPFA executive declined to
answer.195
StemExpress made up to $10,875 in profit for sale of an individual blood product. While
there is no law that bars a firm from valuable consideration for the sale of maternal or umbilical
blood, the fact that StemExpress had such a large profit margin on its blood is key to
understanding the firm.

189

Photograph of StemExpress, LLC, blood donation booth, Exhibit 5.17.

Transcribed Interview of [PP Witness #1](Oct. 6, 2016) at 20.
191
StemExpress, LLC, Donate Blood and Bone Marrow with StemExpress, undated 2
[STEM.HOUSE.SELEC_0192 STEM.HOUSE.SELECT_0195], Exhibit 5.18.
192
StemExpress website, Maternal Blood, http://stemexpress.com/product-category/maternal-blood/
193
StemExpress website, Peripheral Blood, http://stemexpress.com/product-category/peripheral-blood/.
194
StemExpress website, Umbilical Cord Blood, http://stemexpress.com/product-category/umbilical-cord-blood/.
195
See Transcribed Interview of [PP Witness #1] (Nov. 1, 2016).
190

160

4. StemExpress Tissue Technicians Embedded in Planned Parenthood Affiliates: A Typical

Day
The Panel sought to determine whether the PPFA affiliates that had contracts with
StemExpress had any allowable costs under 42 U.S.C. 289g. Documents produced by
StemExpress show the clinics did not. StemExpress had tissue technicians embedded in the
PPFA affiliates. The technicians obtained consent to donate fetal tissue from women scheduled
to undergo abortion. They procured the fetal tissue, packaged it, and shipped it directly to
StemExpress customers. The chart below depicts the typical day of a StemExpress embedded
tissue technician:

161

a) How Researchers Placed an Order

Customers placed orders through an on-line catalogue, a copy of which is shown below
(Panel staff inserted the red circle). Based upon the web page, both Rep. Diane Black (TN-6) and
Rep. Joe Pitts (PA-16) called StemExpress the Amazon.com of baby body parts.196

196

Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel of the H. Comm. on Energy and
Commerce, 114th Cong., Mar. 6, 2016 (unedited transcript 55); The Pricing of Fetal Tissue: Hearing Before the
Select Investigative Panel of the H. Comm. on Energy and Commerce, 114th Cong. 77 (unedited transcript) (Apr. 20,
2016).

162

163

b) Embedded Tissue Technicians Learn of Next Days Scheduled Abortions

The Panel sought to determine whether StemExpress employees had prior knowledge
of the abortions scheduled at PPFA clinics. The Panel determined that, at the beginning of each
workday, StemExpress sent an email to its tissue technicians that informed them of the scheduled
abortions at the clinic to which they were assigned, listed the customer orders for fetal tissue or
body parts (including the gestation requested), and described what specific tissues or parts the
technicians were expected to harvest.
A document produced by StemExpress to the Panel shows that, [t]he day before the
surgery, tissue technicians were required to check the companys web-based system for
researcher requests; Determine your location for the next day; [and] Call the clinic to verify how
many surgeries are scheduled.197 The morning of the abortions, StemExpress emailed the tissue
technicians the daily customer orders, including a list of the specific organs that were ordered,
the desired gestational age of the organs, and other information.198
c) Clinic Personnel Gave Tissue Technicians Access to Patients Private Medical
Information
The Panel sought to determine whether StemExpress employees assigned to PPFA
abortion clinics had access to patients medical information that is protected under HIPAA.
Testimony shows that clinic personnel provided StemExpress embedded tissue technicians with
patients private medical records and other personally identifiable information.199
After StemExpress tissue technicians arrived at their assigned sites, clinic personnel,
including doctors and nurses, allowed StemExpress tissue technicians to review the medical files
of individual patients that were in files attached to the examining room doors, so they could
determine whether women seeking abortions met their order specifications.200 A person with
intimate knowledge of StemExpress operations stated on a CMP video that, often, the head
nurse gives the [tissue technicians] a sheet with a list of everyone who is coming in for that day
with the types of procedures. The [tissue technicians] walk around the clinic and consent the
patients, either in the waiting room or in a patient room.201
If, due to the large volume of patients, StemExpress tissue technicians could not review
the patient files hanging on the examining room doors, clinic personnel allowed them to access
clinic computer terminals that contained confidential patient medical information.202 Doctors

197

StemExpress, LLC, Tissue Procurement for Non-Therapeutic Research, Standard Operating Procedure (Jan. 24,
2011), Exhibit 5.19.
198
Email from [name and title redacted], StemExpress, LLC, to [names redacted], Subject: Updated Task
Assignment: Procurement Schedule Wednesday 3/20/13 (Mar. 20, 2013), Exhibit 5.20.
199
Testimony from a confidential witness.
200
Testimony from a confidential witness.
201
Center for Medical Progress videotape MVI_0064 produced to the Committee on Oversight and Government
Reform.
202
Testimony from a confidential witness.

164

and nurses at the clinics also directed the StemExpress tissue technicians to particular patients
who were good candidates for fetal tissue donations.203
d) Embedded Tissue Technicians Obtained Consent from Women to Donate Fetal Tissue
The Panel sought to determine whether StemExpress employees obtained consent to
donate fetal tissue from women at PPFA clinics who were scheduled to undergo abortions. By
her own admission to the Committee on Energy and Commerce [the Founder and CEO] stated
that StemExpress employees did consent PPFA patients:
StemExpress employee[s] can obtain consent. Once it is already
determined that the patient is having an abortion, they are moved to
a different waiting room, at that point [StemExpress] staff meets
with the patient. If she agrees, they go over the paperwork and she
signs. There are times that PPFA does the consent.204
Documents produced by StemExpress to the Panel show that StemExpress employees
obtained consent to procure fetal tissue from patients scheduled to undergo abortions.205 A
person with intimate knowledge of StemExpress operations stated on a CMP videotape that
some StemExpress tissue technicians would procure fetal tissue specimens without consenting
patients.206
Unlike California PPFA clinics that had contracts with StemExpress, [PP Witness #2]
testified that she would never have allowed such an arrangement at her facility. When Panel staff
asked the witness whether she would have agreed to have employees of an outside vendor obtain
informed consent to donate fetal tissue from PPGC patients, she testified:
I would not agree to have outside staff come in and obtain a crucial
element as the informed consent from our patient population.
Q: Okay. And what is it about that that troubles you?
A: I would like for only our staff to do it, because in that way we
have control over their training. We have control over who is there
day to day obtaining informed consents. We have control to ensure
that its done correctly, and we have the authority to follow up in the
event that our procedures and our processes regarding informed
consent are not followed. I would not permit a third party to come
in and obtain informed consent from our patient population.207
203

Testimony from a confidential witness.

See StemExpress Briefing Notes, Exhibit 5.14.
205
StemExpress, LLC, Consenting Patients, undated, Exhibit 5.21.
206
Center for Medical Progress videotape MVI_0064 produced to the Committee on Oversight and Government
Reform.
207
Transcribed interview of [PP Witness #2] at 97 (Oct. 19, 2016).
204

165

i) When it obtained consent from PPFA Affiliates, StemExpress used PPFAs

consent form
The Panel sought to determine the specific form that StemExpress used to obtain consent
from women scheduled to undergo abortions at PPFA affiliates. The firm produced two forms to
the Panel, one that was created by PPFA, the other by StemExpress. [The Founder and CEO]
told the Committee on Energy and Commerce that, when collecting fetal tissue at PPFA
affiliates, StemExpress used a PPFA consent form, which is different than the consent form at
non-PPFA facilities.208 The PPFA consent form stated, Research using . . . tissue that has been
aborted has been used to treat and find a cure for such diseases as diabetes, Parkinsons disease,
Alzheimers disease, cancer, and AIDS.209
When [PP Witness #1] was asked by the Panel whether the inclusion in the consent form
of the statement that fetal tissue had been used to find a cure for incurable diseases could be
construed as being coercive, the PPFA official testified: I can understand your concern that
perhaps this may make someone think about donating fetal tissue because of this potential.210
The PPFA official testified that the wording of the PPFA consent form may make patients more
likely to want to donate fetal tissue.211
ii) StemExpress used its own consent form when it obtained consent from patients at
independent womens clinics
StemExpress had another consent form that it used at independent womens clinics. That
form purported to be approved by an institutional review board (IRB),212 BioMed IRB.213 The
Panel sought to determine whether BioMed IRB was a legitimate IRB. The Panel determined
that it was not. In March of 2012, the FDA issued a warning letter to BioMed IRB for multiple
violations of agency rules. As a result, the FDA ruled it will withhold approval of all new
studies approved by BioMed IRB, and [n]o new subjects are to be enrolled in any ongoing
[BioMed IRB] studies . . .214 That ban was lifted in January 2013.215
Prior to the FDA suspension, the House Committee on Energy and Commerce had
investigated BioMed IRB as part of an investigation into the ability of IRBs to protect human
208

StemExpress Briefing Notes, Exhibit 5.14.

Planned Parenthood Federation of America, PPFA Manual of Medical Standards and Guidelines, Client
Information and Informed Consent, Donation of Blood and/or Aborted Pregnancy Tissue for Medical Research,
Education, or Treatment, Revised June 2011 [PPGC-HOU-E&C-000006], Exhibit 5.22.
210
Transcribed interview of [PP Witness #1] (Oct. 6, 2016), at 131-132.
211
Id. at 132.
212
StemExpress Briefing Notes, Committee on Energy and Commerce (Aug. 25, 2016).
213
BioMed IRB Informed Consent to Participate in a Clinical Research Study, Sponsor: StemExpress, LLC (Jan. 24,
2011) [STEM.HOUSE.SELECT_0680 STEM.HOUSE.SELECT_0681], Exhibit 5.23.
214
See Letter from [Compliance Official], U.S. Food and Drug Administration, to [Executive], Biomedical Research
Institute of America dba BioMed IRB (Mar. 29, 2012),
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm298607.htm.
215
Id.
209

166

subjects in biomedical research.216 That investigation led the Committee to believe that the IRB
application approval process is essentially perfunctory, lacking vigorous oversight and controls,
and thus raising the risk of some IRBs not adequately protecting the safety of human
subjects.217
On March 29, 2016, the Panel issued a subpoena to BioMed IRB which required it to
produce documents sufficient to show BioMed IRBs ongoing oversight, within the definition of
45 C.F.R. 46, of any entity involved with fetal tissue research or transplantation of fetal tissue for
which it issued an IRB approval.218 The BioMed IRB [Executive] informed the Panel on April 4,
2016, that, regarding StemExpress IRB records, there are none.219 After he refused to comply
with the Panels subpoena, [Executive] told the Panel: Please schedule the contempt process at
the earliest possible date.220 The Panel still has yet to receive any documents from BioMed IRB.
e) StemExpress Tissue Technicians Procured the Fetal Tissue
The Panel sought to determine whether StemExpress embedded tissue technicians or
PPFA procured fetal tissue after abortions. [The Founder and CEO] told the Committee on
Energy and Commerce that StemExpress staff are the only ones procuring tissue at PPFA
facilities.221
StemExpress produced documents about its procurement kit to the Panel that provided
explicit instructions to its tissue technicians on the method to procure fetal tissue.222 The kit
included directions on the method to obtain consent from patients, to harvest body parts and fetal
tissue, and to package and ship the products once obtained.223 At independent abortion clinics,
StemExpress tissue technicians were required to procure the specimen(s) on the petri dish [that
were included in the technicians packages. . . .224
In contracts with the PPFA affiliates with which StemExpress had contracts, [PP Witness
#2] testified that she would never have allowed such an arrangement at her facility:
A: From my ancillary knowledge of our abortion services area, it
appears highly regulated. And just like the informed consent for
researchers, I cant see that we would allow staff that are not or
people in general that are not Planned Parenthood staff to go into the
216

See Letter from Rep. John D. Dingell, Chairman, H. Comm. on Energy and Commerce, to [Executive],
Biomedical Research Institute of America, et al. (Dec. 13, 2007).
217
See Memorandum from Committee staff to Members and Staff Subcomm. on Oversight and Investigations (Mar.
23, 2009).
218
See Subpoena to Biomedical Research Institute of America dba BioMed IRB (Mar. 29, 2016).
219
See Email from [Executive], Biomedical Research Institute of America, to Panel staff (Apr. 4, 2016).
220
Id.
221
StemExpress Briefing Notes, Exhibit 5.14.
222
StemExpress, LLC, Work Instruction, StemExpress Procurement Kit 1 (Mar. 12, 2015)
[STEM.SELECT.HOUSE_0266 STEM.HOUSE.SELECT_0272], Exhibit 5.24.
223
Id.
224
Tissue Procurement for Non-Therapeutic Research, Standard Operating Procedure, Exhibit 5.19.

167

facility and be involved in the setup of the room where abortions are
obtained.
Q: So all of the little daily things that can go on, lets go back to
consent. All the manner, the manners, the time, the thoughtfulness,
understanding what you call the supplemental consent, the IRB
consent, because these are staff that work directly for the clinic, you
can manage them and tweak even the smallest of behaviors or
practices, migrate the whole process in a direction thats under the
management of you and others; is that right?
A: That would be my personal preference, yes.225
The Panel sought to determine whether StemExpress procurement practices were driven
by a desire to assist medical researchers find potential cures for diseases or by a profit motive.
StemExpress standard operating instructions that were used at non-Planned Parenthood abortion
clinics indicate it was profit. StemExpress instructed its tissue technicians:
If you have an excellent [fetal tissue] sample with no researcher
listed on todays schedule, please contact [Founder & CEO]
immediately, and they will work to call researchers who may be
interested even though they are not currently scheduled.226
i) After they procured the body parts and tissue, StemExpress employees packaged and
shipped them directly to StemExpress customers
Documents produced by StemExpress to the Panel show that, along with being
responsible for consent and procurement, the firms tissue technicians also packaged and shipped
the fetal tissue.
StemExpress procurement kit provided detailed instructions on the method tissue
technicians should use to package fetal tissue:
The items of the kit should be reassembled in the same placement as
they were when the kit was received.
Place the specimens inside of the plastic bag liner
One sealed biohazard bag with the 50ml conical tube (containing
RPMI and the liver specimen) [along with] One sealed biohazard
bag with 3 tubes of maternal blood (two 10ml EDTA one 5ml Z
serum sep. [sic] clot activator blood collection tube) [and] 2 chilled
gel packs
225
226

Transcribed interview of [PP Witness #2] (Oct. 19, 2016) at 98.

Tissue Procurement for Non-Therapeutic Research, Standard Operating Procedure, Exhibit 5.19.

168

Seal the plastic bag liner by tying it in a knot

Place the tied plastic bag inside of the Styrofoam box
Place the Styrofoam lid on the Styrofoam box
Adhere a biohazard sticker on opposite sides of the Styrofoam box
so they seal the top of the box to the bottom.
Place Styrofoam box inside the cardboard box
Place completed Procurement Form on top of the Styrofoam box
Tape the cardboard box shut
Adhere the FedEx shipping label to the top of the cardboard box
Once the package is ready for shipment call FedEx . . . to schedule
a pick up or drop the package off at the nearest FedEx location by
16:30 on the day of procurement.227
The firm also issued its tissue technicians a four-page document on how to package and
ship tissue samples.228 StemExpress standard operating procedure stated:
Packaging the specimens and blood [samples] for shipment once all
specimens have a number. Be sure to place them on ice or cold packs
. . . . For delivery: If the specimen is local courier, be sure to call the
courier once you know you have obtained an appropriate specimen.
If the specimen is going by FedEx, be sure to know the local cut-off
times for your closest FedEx office. Each FedEx location is listed
under contacts in [StemExpress web-based system].229
ii)

StemExpress tissue technicians had a financial incentive to procure the most

body parts and fetal tissue possible

Documents StemExpress produced to the Panel indicated the tissue technicians did have
such a potential conflict of interest. PPGCs research director testified that she had similar
concerns.230

227

Work Instruction, StemExpress Procurement Kit 1, Exhibit 5.24.

StemExpress, LLC, Packaging Blood and Tissue Samples (Jan. 16, 2014) [STEM.HOUSE.SELECT_0257
STEM.HOUSE.SELECT_0260], Exhibit 5.25.
229
Tissue Procurement for Non-Therapeutic Research, Standard Operating Procedure, Exhibit 5.19.
230
Transcribed interview of [PP Witness #2] (Oct. 19, 2016) at 162-164.
228

169

StemExpress tissue technicians were compensated at a rate of $10 per hour plus a per
tissue or blood bonus that varied depending upon the type of tissues and the amount they
procured. The document produced by StemExpress is below.231

231

StemExpress, LLC, Procurement Technician Compensation Policy for Tissue and Blood Procurement Effective
01/01/2013 [STEM.HOUSE.SELECT_0672 STEM.HOUSE.SELECT_0674].

170

171

The Panel sought to determine whether StemExpress payment rate was standard practice
at abortion clinics which participated in fetal tissue donation programs. The Panel found it was
not. When [PP Witness #2] was asked whether she would allow tissue technicians employed by
an outside firm, who were reimbursed by the outside firm based on the amount of tissue they
procured, into her facility, she testified, Thats not something I would initiate in our
organization, no.232
The Panel determined that the PPFA affiliates at which StemExpress procured fetal tissue
had no allowable costs under 42 U.S.C. 289g. StemExpress embedded tissue technicians
obtained consent to donate fetal tissue from women scheduled to undergo abortion, procured the
fetal tissue, packaged it, and shipped it directly to StemExpress customers. Thus, the Panel
determined the PPFA affiliates had no allowable costs.
5. StemExpress Due Diligence
The Panel sought to evaluate StemExpress level of due diligence before entering into
contracts with the independent abortion clinics at which it procured fetal tissue. The Panel
discovered StemExpress failed to examine the disciplinary records of officials and doctors at
those independent clinics.
The director of one clinic, and doctors at others, were disciplined multiple times by state
regulators. In addition, multiple clinic doctors settled malpractice suits. Panel staff found these
issues through simple online searches, which raises the question of whether StemExpress did any
background checks on the clinics or doctors with which it did business.
At Camelback Family Planning, the clinic official who signed the contract with
StemExpress had multiple disciplinary proceedings for substance abuse, two of which occurred
before she signed the StemExpress signed contract. Even though she performed abortions, the
doctor was not an Ob/Gyn. The doctor surrendered her license to practice medicine.
The Presidential Womens Specialists clinic settled four malpractice suits, including one
that involved a woman who died five days after an abortion surgical instruments were left inside
her body. Three of the clinics doctors have either been disciplined by the state department of
health, including performing an abortion on a 12-year-old girl (which is below the age of consent
in the state), destroying evidence related to that case, and not informing law enforcement of child
abuse. The state charged the same doctor with gross or repeated malpractice involving another
patient.
One doctor who performs abortions at Cedar River Clinics has been disciplined by the
state, and another settled a malpractice suit that alleged that he had to perform an emergency
hysterectomy after he perforated the patients uterus during an abortion.

232

Transcribed interview of [PP Witness #2] at 114-15 (Oct. 19, 2016).

172

6. Payments Received by Clinics

Between 2010 and the middle of 2015, StemExpress paid the clinics from which it
procured fetal tissue a total of $152,460. Between 2010 and the middle of 2015, StemExpress
paid the clinics a total of $366,443 for both blood and fetal tissue.233 StemExpress produced over
a hundred monthly invoices from PP affiliate clinics. Stem refused to produce invoices for other
clinics from which it procured fetal tissue. The Panel sought those invoices directly from those
clinics. StemExpress paid the following amounts for fetal tissue. These numerical sums are
calculated by the Panels forensic accountant from these invoices:

$123,175 to Planned Parenthood Mar Monte

$12,705 to Planned Parenthood Shasta Pacific

$8,130 to Family Planning Services

$4,875 to Presidential Womens Center

$2,375 to Cedar River Clinics

$1,200 to Camelback Family Planning.

Over the same time period (2010 through the middle of 2015), StemExpress paid the clinics a
total of $213,983 for blood draws. StemExpress produced over a hundred monthly invoices from
Planned Parenthod affiliate clinics. StemExpress refused to produce invoices for other clinics
from which it procured fetal tissue. The Panel sought those invoices directly from those clinics.
These numerical sums are calculated by the Panels forensic accountant from these invoices.
StemExpress paid:

$100,143 to Planned Parenthood Mar Monte

$88,625 to Cedar River Clinics

$10,905 to Presidential Womens Center

$7,750 to Planned Parenthood Shasta Pacific

$6,415 to Family Planning Services for blood.

233

Planned Parenthood Mar Monte, Planned Parenthood Shasta Pacific, Planned Parenthood of Santa Barbara,
Ventura & San Luis Obisbo Counties, Camelback Family Planning, Cedar Rivers Clinics, Family Planning
Specialists Medical Group. Presidential Women's Center, and Womens Health Specialists produced to the Panel
documents that reflected payments the entities had received from StemExpress, LLC. Panel staff conducted a
forensic accounting analysis of those payments to determine the total amounts to the entities.

173

During the course of its investigation, the Panel sought to determine the motive of clinic
executives when they entered into their contracts with StemExpress. In at least one instance, an
executive from a clinic at which StemExpress procured fetal tissue indicated that profit may have
been a motive. [Clinic Executive #1] stated to CMP journalists that the clinic made
approximately $250,000 a year from fetal tissue and blood donations:
[Clinic Executive #1]: [Laughter] Well, I justweve been into this,
and its been very good. And now weve gone through our first
year
CMP journalist: Yeah.
[Clinic Executive #1]: I mean, I was looking at numbers of, you
know, $250,000 a year. And now
CMP journalist: Im sorry, say that again?
[Clinic Executive # 1]: I mean, originally, we were looking at
numbers of about $250,000 a year. Last year I did $100,000.234
The Panel notes that, in most instances, the clinics had little or no allowable reimbursable
costs as permitted under 289g-2.
7. Payments Received by StemExpress for Its Resale of Fetal Tissue
StemExpress produced invoices that it sent to customers. The numerical sums listed
below are calculated by the Panels forensic accountant from these invoices. Invoices produced
to the Panel by StemExpress show that, between 2011 and 2016, StemExpress received a total of
$593,152 in payments from its customers. The invoices show the total payments from customers
included $59,300 in payments for disease screening and $53,110 for the shipment or delivery of
fetal tissue products.
The Panel notes that, in addition to fresh fetal tissue and body parts, StemExpress sold
products derived from fetal tissue. The invoices produced by StemExpress to the Panel do not
reflect the sale of products derived from fetal tissue.
Below is a chart of StemExpress customers, and the amounts the customers paid the firm
(all amounts are in U.S. dollars).

234

Center for Medical Progress, videotape FNND0569_ 20150419153726 (Apr. 7, 2014) produced to the Committee
on Oversight and Government Reform.

174

CLIENT

2011

2012

2013

AllCells, LLC.

73,045

7,720

4,880

85,645

5,785

1,630

7,415

Baylor College
of Medicine
Beckman
Research
Institute City of
Hope

545

2014

2015

2016

760

Childrens
Hospital of
Philadelphia

GRAND
TOTAL

$2,065

695

695

1,390

Columbia
University
Medical Center

615

3,715

995

5,325

Colorado State
University

3,835

1,645

2,930

8,410

Dartmouth
University

3,920

5,010

585

9,515

Drexel
University
College of
Medicine

3,680

3,680

Ganogen, Inc.

6,535

George
Washington
University

350

Harvard
University
Howard Hughes
Medical
Institute

805

350

8,610

340

7,340

8,610

695

1,035

175

Johns Hopkins
Hospital

1,950

Massachusetts
General
Hospital

1,680

4,560

3,630

10,705

Medical
College of
Wisconsin

15,265

2,740

Neurona
Therapeutics
Ohio State
University

1,830

490

855

37,940

1,830

490

Rockefeller
University
Stanford
University

2,740

42,739

Thomas
Jefferson
University

18,050

855

57,070

27,190

182,989

500

500

University of
California. Los
Angeles

3,920

8,920

9,000

21,840

University of
Connecticut
Health Center

780

1,700

500

2,980

335

820

1,155

62,195

23,705

University of
Illinois at
Chicago
University of
Massachusetts
Medical School

62,275

2,159

176

491

150,825

University of
Minnesota

3,235

University of
North Carolina,
Chapel Hill

720

University of
Pennsylvania
Vanderbilt
University
Medical Center

11,955

9,665

Yale University
School of
Medicine

515

12,065

Zyagen

5,080

1,835

2,555

4,790

4,790

5,640

845

-125

12,580

3,570

TOTAL ALL
CUSTOMERS

8,659
$593,152

8. The Select Panel Recommends that the House Find StemExpress in Contempt of

Congress
For nearly a year, the Panel sought documents, including accounting documents, from
StemExpress.235 In its first response to the Panels document request, StemExpress provided very
limited information. StemExpress produced a general accounting summary that stated: [F]etal
tissue procured from Planned Parenthood Affiliates generated approximately $50,000 in gross
(pre-tax) revenue against expenses in excess of $75,000.236
As a result of StemExpress limited compliance with the Panels document request letter,
the Chairman, over a three-month period, issued two subpoenas to StemExpress,237 one to the
founder & CEO,238 and another to StemExpress outside accountant, Scinto Group, LLP
(Scinto).239

235

Letter from Rep. Marsha Blackburn, Chairman, House Select Investigative Panel, to [Founder and CEO,
StemExpress, LLC] (Dec. 17, 2015), Exhibit 5.1.1.
236
StemExpress First Response to House Select Panel Document Requests (Jan. 15, 2016), Exhibit 5.2.
237
Subpoena to StemExpress, LLP, (Feb. 12, 2016), Exhibit 5.3.
238
See Subpoena to [Founder & CEO] (Mar. 29, 2016).
239
See Subpoena to Scinto Group, LLP (Apr. 29, 2016)

177

[The Founder and CEO] refused to comply with the Panels March 29, 2016,
subpoena.240 Like the Panels February 12, 2016, subpoena to StemExpress, the subpoena issued
to [the Founder and CEO] requested the names of StemExpress accounting personnel and
documents showing accounts payable and receivable.241 [The Founder and CEO] refused to
provide any of the information demanded by the Panels subpoena.
In addition, she suggested that the Panel seek the information it required from Scinto or
from [Former StemExpress Employee]. Once again, attorneys for [the Founder and CEO] offered
summary documents of revenue and costs, but no accounting records.242 [The Founder & CEO]s
and StemExpress counsel, who also represented [Former StemExpress Employee], explained
that [Former StemExpress Employee] had only W-2s and related tax information. For her part,
[Former StemExpress Employee] told Panel staff that she had no documents and that if the Panel
contacted her again she would consider it harassment.243
Scinto refused to comply with the Panels subpoena and to date has provided no
accounting documents. Scinto told the Panel that StemExpress objected to Scintos compliance
with the Panels subpoena on the grounds of several privileges.244 The Panel informed Scinto
that its objections based upon the asserted privileges were inapplicable and do not impair the
legal requirement to comply with a congressional subpoena.245 Despite these efforts, Scinto
refused to comply with the Panels subpoena.246
On August 23, 2016, McDermott Will & Emery, the law firm previously representing
StemExpress and [the Founder and CEO] throughout the course of the investigation, informed
the Panel that StemExpress was no longer their client.247 StemExpress former attorney supplied
the Panel with contact information for the new lawyer.248 On September 8, 2016, Chairman
Blackburn sent a letter to Mr. Frank Radoslovich, the new counsel for StemExpress, and [the
Founder and CEO], outlining a brief history of the Panels interactions with StemExpress, and

StemExpress First Response to House Select Panels March 29, 2016 Subpoena [STEM.HOUSE.SELECT_0713
STEM.HOUSE.SELECT_0715], Exhibit 5.26.
241
See Subpoena to [Founder & CEO] (Mar. 29, 2016).
242
StemExpress First Response to House Select Panels March 29, 2016 Subpoena [STEM.HOUSE.SELECT_0713
STEM.HOUSE.SELECT_0715], Exhibit 5.26.
243
See Memorandum from House Select Investigative Panel Counsel to Majority Members of the House Select
Investigative Panel (Mar. 7, 2016).
244
Letter from Kevin Murphy, Carr Maloney LLP, to T. March Bell, Chief Counsel and Staff Director, Select
Investigative Panel on Infant Lives [sic] (Sept, 16, 2016), Exhibit 5.1.6.
245
See T. March Bell, Chief Counsel and Staff Director, House Select Investigative Panel, to Kevin Murphy, Carr
Maloney LLP (Sept. 8, 2016), Exhibit 5.1.5
246
Letter from Kevin Murphy, Carr Maloney LLP, to T. March Bell, Chief Counsel and Staff Director, Select
Investigative Panel on Infant Lives [sic] (Sept., 16, 2016), Exhibit 5.1.6 ( . . . if not for the potential application of
the privilege and/or confidentiality laws, Scinto Group LLP would be willing and able to comply with a valid
subpoena from the Select Investigative Panel. However, in light of the potential application of those laws, under the
current circumstances, Scinto Group is not in a position to unilaterally respond to the subpoena with the requested
documents, absent client consent.).
247
See Email from Amandeep S. Sidhu, McDermott Will & Emery, to Panel Staff (Aug. 23, 2016).
248
Id.
240

178

the Panels unsuccessful attempts to reach an accommodation with StemExpress.249 The letter
concluded:
Since StemExpress has been unwilling to comply with the Panels
subpoenas and having exhausted all its efforts to obtain compliance
from the subpoena recipients, the Chairman of the Select
Investigative Panel will recommend that StemExpress and
[StemExpress Founder and CEO] be held in contempt for their
willful failure to fully comply with the Panels subpoena issued to
them . . . . 250
The Chairman provided one last opportunity for StemExpress and [the Founder and
CEO] to comply with the subpoenas.251 In April 2016, the Panel wrote a letter to [the Founder
and CEO] that included a chart of the missing items in an attempt to secure compliance with the
congressional subpoenas.252 In a response letter, former counsel for StemExpress and [the
Founder and CEO] disputed the Panels attempt to clarify what was missing.253 After receiving
no substantive reply from StemExpress new counsel, the Panel, on September 21, 2016, voted
unanimously to recommend that the House of Representatives hold StemExpress and [the
Founder and CEO] in contempt of Congress.254
9. StemExpress May Have Violated Federal Laws and Regulations
H. Res. 461 required the Panel to undertake an investigation into medical procedures
and business practices used by entities involved in fetal tissue procurement . . . and any changes
in law or, regulation necessary resulting from its investigation.255
The Panel, acting pursuant to H. Res. 461, determined that StemExpress may have
violated applicable federal and state laws, and regulations promulgated by the Department of
Health and Human Services. The Panel referred StemExpress apparent violations of laws to
appropriate federal and state law enforcement and violations of regulations to the appropriate
agency. (See Chapter IV for a discussion of the criminal referrals made by the Panel.)

249

See Letter from Rep. Marsha Blackburn, Chairman, Select Investigative Panel, to Frank Radoslovich, counsel for
StemExpress (Sept. 8, 2016), Exhibit 5.1.7.
250
Id.
251
Id.
252
See Letter from Rep. Marsha Blackburn, Chairman, Select Investigative Panel, to [Founder and CEO],
StemExpress, LLC (Apr.28, 2016), Exhibit 5.1.8.
253
See Letter from Amandeep S. Sidhu, McDermott Will & Emery, to Rep. Marsha Blackburn, Chairman, House
Select Investigative Panel (May 6, 2016), Exhibit 5.1.9
254
See Select Investigative Panel of the H. Comm. on Energy and Commerce, Business Meeting, unedited transcript,
Sept. 21, 2016.
255
H. Res. 461 (Oct. 7. 2015).

179

d) 18 U.S.C. 1519
18 U.S.C. 1519 makes it a 20-year felony for Whoever knowingly alters, destroys,
mutilates, conceals, covers up, falsifies, or makes a false entry in any record, document, or
tangible object with the intent to impede, obstruct, or influence the investigation or proper
administration of any matter within the jurisdiction of any department or agency of the United
States . . . .256
The Panel determined that StemExpress may have violated 18 U.S.C. 1519 by
potentially destroying documents pertinent to congressional investigations into the fetal tissue
industry, including documents that were covered by the Panels subpoenas. The Panels two
subpoenas to StemExpress direct that No records, documents, data or information called for by
this request shall be destroyed, modified, removed, transferred or otherwise made inaccessible to
the Select Panel.257
StemExpress bank produced to the Panel banking records that show StemExpress
payments to Shred-It USA that, for the most part, correspond with dates of document demand
letters from congressional investigations of the fetal tissue industry, subpoenas from the Panel,
and StemExpress productions to the Panel and other congressional inquiries. StemExpress bank
records dating back to November 2012 reveal there were no payments made to Shred-It USA
prior to the first congressional investigations into the fetal tissue industry. Since the first
congressional inquiries began, and continuing through the Panels investigation, StemExpress
made payments to Shred-It USA.
The Panel cannot determine what specific documents StemExpress shredded, but the
timing raises the question of whether StemExpress knowingly and willfully attempted to avoid
productions to a congressional inquiry.
e) 42 U.S.C. 289g-2
42 U.S.C. 289g-2(a) states, It shall be unlawful for any person to knowingly acquire,
receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer
affects interstate commerce. Under that law, the term valuable consideration does not include
reasonable payments associated with the transportation, implantation, processing, preservation,
quality control, or storage of human fetal tissue.258 Human fetal tissue is defined broadly to
include any tissue or cells obtained from a dead human embryo or fetus after a spontaneous or
induced abortion, or after a stillbirth.259

256

18 U.S.C. 1519.
Subpoena to StemExpress, LLP, (Feb. 12, 2016), Exhibit 5.3; Instructions Item 5 (Mar. 29, 2016).
258
42 U.S.C. 289g-2(e)(3).
259
42 U.S.C. 289g-l(g).
257

180

f) California Health and Safety Code Section 125320

The California Health and Safety Code contains virtually identical language as 42 U.S.C.
289g-2. That law states that:
(a) A person may not knowingly, for valuable consideration, purchase
or sell embryonic or cadaveric fetal tissue for research purposes
pursuant to this chapter.
(b) For purposes of this section, valuable consideration does not
include reasonable payment for the removal, processing, disposal,
preservation, quality control, storage, transplantation, or
implantation of a part.
(c) Embryonic or cadaveric fetal tissue may be donated for research
purposes pursuant to this chapter.260
As with 289g, another provision of the California Health and Safety Code broadly
defines tissue to mean a human cell, group of cells, including the cornea, sclera, or vitreous
humor and other segments of, or the whole eye, bones, skin, arteries, sperm, blood, other fluids,
and any other portion of a human body . . ."261
The Panel determined that StemExpress may have violated 42 U.S.C. 289g-2 and Cal.
Health & Safety Code 125320(a). This can be seen generally by the companys aggressive
growth strategy, which explicitly included the goal of generating profit, and specifically by the
transactions involving the transfer of fetal tissue to and from numerous entities for consideration
that exceeded statutorily allowable costs.
g) HIPAA
The HIPAA privacy rule is described in detail in Chapter II. The Panel determined that
StemExpress may have committed systematic violations of the HIPAA Privacy Rule from about
2010 to 2015. StemExpress did not have a medically valid reason to see patients PHI.
StemExpress contracts with PPFA affiliates contend that the tissue procurement firm was a
business associate. That statement does not comport with HIPAA or with CRS interpretation of
the statute.
h) HHS Regulations on Informed Consent
The Department of Human Service regulations that require researchers to obtain
informed consent from each human being used as a research subject, and that outline the
elements of informed consent that shall be provided to each subject are described in detail in
Chapter III: Panel Hearings.
260
261

Cal. Health & Safety Code 125320.

Cal. Health & Safety Code 1635(c).

181

The Panel has determined that StemExpress may have violated the HHS regulations on
informed consent. When it obtained informed consent from patients at PPFA affiliates,
StemExpress used the PPFA consent form, which states that fetal tissue has been used to cure
diseases. For example, the PPFA consent form used by Planned Parenthood Los Angeles states,
Research using . . . tissue that has been aborted has been used to treat and find a cure for such
diseases as diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS.262
Numerous witnesses, including senior PPFA officials, testified before the Panel that the
PPFA consent form is misleading and unethical due to its contention that fetal tissue has been
used to find a cure for diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS. [PP
Witness #1] testified that the PPFA consent form contained inaccurate statements, and that she,
the person who oversees the production of the PPFA manual that contains the consent form, was
not happy that an inaccurate document was in the manual:
Q: Have we found a cure for cancer?
A: If we had found a cure, we wouldnt be asking for tissue
donations to try to find a cure.
Q: Have we found a cure for AIDS?
A: Not that Im aware of, not yet.263
[A:] . . . To my knowledge there is no cure for AIDS. So that is
probably an inaccurate statement . . . . a consent form should not
have an incorrect statement [on it].264
i) HHS Regulations on Coercion
The HHS regulations further state: When some or all of the subjects are likely to be
vulnerable to coercion or undue influence, such as . . . pregnant women . . . additional
safeguards are included.265
The Panel sought to determine whether StemExpress coerced women who underwent
abortions. The Panel determined that such coercion on the part of StemExpress may have
occurred. For example, emails produced by StemExpress to the Panel show that its tissue
procurement technicians engaged in real-time email correspondence with researchers while
abortions were taking placepresumably before they obtained informed consent to procure fetal
tissueand yet StemExpress employees already were promising to deliver fetal tissue.
On January 22, 2015, at 12:26 p.m., a customer emailed a StemExpress employee stating:
Just wanted to check in and see if there are any cases within our gestation range for today?

262

Planned Parenthood Consent Form, Exhibit 5.22.

Unedited transcribed interview of [PP Witness #1] at 130 (Oct. 6, 2016).
264
Unedited transcribed interview of [PP Witness #1] at 131 (Oct. 6, 2016).
265
45 C.F.R. 46.111(7)(b).
263

182

Need to book some time on the equipment if so.266 Within minutes, at 12:30:11 p.m., the
StemExpress employee replied: There is one case currently in the room, I will let you know
how the limbs and calvarium [skull] look to see if you are able to take them in about fifteen
minutes.267 Less than two minutes later, the customer wrote: Great thank you so much.268 At
1:20:32 p.m., the StemExpress employee informed the customer:
The calvarium is mostly intact, with a tear up the back of the suture
line, but all pieces look to be there. The limbs, one upper and one
lower, are totally intact, with one upper broken at the humerus, and
one lower broken right above the knee. Please let me know if these
are acceptable. I have set them aside and will await your reply.269
Approximately five minutes later, the customer replied: That sounds great we would like
both of them. Please send them our way. Thanks again . . .270 The StemExpress employee
responded: Limbs and calvarium will be there between 3:30 and 4:00.271
[PP Witness #1] testified before the Panel that the PPFA consent form used by
Novogenix may coerce women to donate fetal tissue. When she was asked whether the incorrect
statement that fetal tissue has found a cure for various diseases could be viewed as coercive or
. . . more likely to induce somebody to want to donate fetal tissue, the PPFA executive testified:
I can understand your concern that perhaps this may make someone think about donating fetal
tissue because of this potential.272
j) HHS Regulations on Institutional Review Boards
HHS regulations require IRBs to prepare and maintain adequate documentation of their
activities, including copies of all research proposals reviewed, scientific evaluations of those
proposals, minutes of IRB meetings, records of continuing review activities, and copies of all
correspondence between the IRB and the investigators.273 The HHS IRB regulations only cover
investigations of products regulated by the Food and Drug Administration.274
The Panel sought to determine whether any of the fetal tissue procured by StemExpress
and resold to researchers was used in any product regulated by the FDA. The Panel could not
make such a determination due to the lack of documentation provided by StemExpress.

StemExpress, LLC, purchase order and emails [STEM.HOUSE.SELECT_0369

STEM.HOUSE.SELECT_0382], Exhibit 5.27.
267
Id..
268
Id.
269
Id.
270
Id.
271
Id.
272
Unedited transcribed interview of [PP Witness # 1] at 131-32 (Oct. 6, 2016).
273
45 C.F.R. 46.115(a).
274
21 C.F.R. 56.101(a).
266

183

The Panel sought to determine whether BioMed IRB, which StemExpress represented
approved its research, complied with 45 C.F.R. 46. By its own admission, BioMed IRB violated
the HHS regulations by it representation to the Panel that it had no records that related to
StemExpress.
The Panel, as a result, determined that StemExpress may have violated 45 C.F.R. 46
through statements that the firm provided abortion clinics with IRB Certified Consents, and that
Our IRB approved protocols and consents protect you as well as donors privacy in accordance
with HIPAA guidelines. Those representations appeared on brochure distributed at the NAF
meetings.
k) California Revenue and Tax Code
A provision of the California Revenue and Tax Code states:
[E]very retailer engaged in business in this state and making sales
of tangible personal property for storage, use, or other consumption
in this state, not exempted . . . shall, at the time of making the sales
or, if the storage, use, or other consumption of the tangible personal
property is not then taxable hereunder, at the time the storage, use,
or other consumption becomes taxable, collect the tax from the
purchaser and give to the purchaser a receipt therefore in the manner
and form prescribed by the [California State Equalization Board].275
The law defines a retailer engaged in business in California as Any retailer maintaining,
occupying, or using, permanently or temporarily, directly or indirectly, or through a subsidiary,
or agent, by whatever name called, an office, place of distribution, sales or sample room or place,
warehouse or storage place, or other place of business.276
There is an exemption for the sale of human blood and human body parts.277
StemExpress is not a tissue or blood bank; rather, it sells fetal tissue cells, cell lines, and other
products directly to customers. The California State Board of Equalization (SBE) recently
collected nearly $82,000 for unpaid sales taxes for a non-profit organization that saves dogs,
draws blood from those dogs, and sells the white blood cells, plasma, and red blood cells for
transfusions into other canines.278
Cal. Rev. & Tax Code 6203. A publication put out by the State Board of Equalization (SBE) states that
provision applies to corporations, individuals, Limited Liability Companies, Limited Liability Partnerships, Limited
Partnerships, partnerships, married co-owners, registered domestic partnerships, and organizations. See Cal. State
Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the Sales and Use Tax
Law, Pub. 72, at 1 (May 2014).
276
Cal. State Bd. of Equalization, Laws, Regulations & Annotations, Sales and Use Tax Law, Chapter 3. The Tax,
https://www.boe.ca.gov/lawguides/business/current/btlg/vol1/sutl/6203.html.
277
Cal. Rev. & Tax Code 33 (Human whole blood, plasma, blood products, and blood derivatives, or any human
body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose.).
278
Chris Haire, Greyhound Dog Rescue Hemopet Fights to Stay Open after $82,000 Tax Bill, Orange County
Register, Oct. 10, 2016, http://www.ocregister.com/articles/blood-731674-hemopet-greyhounds.html.
275

184

The statute defines tangible personal property as personal property which may be seen,
weighed, measured, felt, or touched, or which is in any other manner perceptible to the
senses.279 Thus, cells and cell lines are tangible personal property under the California Sales and
Use Tax.
An SBE publication states that California companies can pass along the amount of sales
tax to customers, provided the business lists a separate amount for sales tax reimbursement on its
receipts or invoices, or if the sales agreement specifically calls for the addition of sales tax
reimbursement.280 If the business includes sales tax reimbursement in its prices, companies
must inform the buyer that tax is included by making one of the following statements on a
price tag or in an advertisement: All prices of taxable items include sales tax reimbursement
computed to the nearest mill, or The price of this item includes sales tax reimbursement to the
nearest mill.281 Neither of those statements are on StemExpress website, nor in any
advertisements or brochures produced to the Panel.
Under the California Revenue and Tax Code:
Internet sales are treated just like sales made at retail stores, by sales
representatives, over the telephone, or by mail order. If your
business is located in California, retail sales of tangible personal
property that you make over the Internet to California customers are
generally taxable unless the sales qualify for a specific tax
exemption or exclusion . . . and you are required to register for a
permit and report and pay tax to the same extent as any other retailer
in California.282
The Panel sought to determine whether StemExpress complied with the California
Revenue and Tax Code. The Panel has determined StemExpress may have violated that statute
because it did not charge the legally required sales tax to its California-based clients.
10. The Panel Makes Criminal Referrals Based on StemExpress Apparent Violations of Law
and Federal Regulations
The Panel sent criminal referrals that allege StemExpress may have violated applicable
federal and state laws, and federal regulations to the following authorities:

The U.S. Attorney General related to potential violations by StemExpress of 18 U.S.C.

1519 and 42 289g-2.

279

Cal. Rev. & Tax Code 6016.

Cal. State Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the
Sales and Use Tax Law, Pub. 72, at 5 (May 2014).
281
See id.
282
Cal. State Bd. of Equalization, Publication 109 Internet Sales 5, https://www.boe.ca.gov/formspubs/pub109/.
280

185

The El Dorado County, California, District Attorney related to potential violations by

StemExpress of the California Health and Safety Law, and the California Tax Revenue
and Tax Code.

The U.S. Department of Health and Human Services related to potential violations of the
Health Insurance Portability and Accountability Act of 1996.

The U.S. Department of Health and Human Services related to potential violations 45
C.F.R. 46.

B. DaVinci Biosciences, LLC/DaVinci Biologics, LLC: A Case Study

7. Summary
Documents obtained by the Panel and a lawsuit filed by the Orange County, California
District Attorney283 suggest that DaVinci Biosciences, LLC (DaVinci), and DaVinci Biologics,
LLC (DVB) were driven by one motive: profit. Documents cited in the District Attorneys
lawsuit show that DaVinci and DVB charged considerably more for fetal tissue and cell lines
derived from that tissue than the costs it incurred. The firms business and marketing plans show
that officers and directors pushed their employees to sell more and more tissue, and thus
increased DaVinci and DVBs bottom line. The companys sole source of fetal tissue was at
Planned Parenthood of Orange and San Bernardino Counties.
The Panel has uncovered evidence that DaVinci and DVB may have violated 42 U.S.C.
289g-2 and provisions of the California Health and Safety Law and the California Tax Revenue
and Tax Code.
c) Background of DaVinci and DVB
DaVinci was founded as a for-profit corporation with the California Secretary of State on
December 19, 2007.284 DVB was also founded as a for-profit corporation and filed its
incorporation papers with the California Secretary of State on March 16, 2009.285 DVB was and
remains located at the same physical location as DaVinci.286 The California Franchise Tax Board
revoked DaVincis powers, rights, and privileges on July 28, 2015.287 It took the same action
against DVB on November 3, 2014.288
Such revocations occur when an entity fails to do the following: File a tax return; Pay
taxes or penalties (including any to the Secretary of State penalty); Pay fees (such as collection,
283

Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
284
California Secretary of State, Business Entity Detail, http://kepler.sos.ca.gov.
285
Id.
286
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
287
Id.
288
Id.

186

filing enforcement, lien, sheriff, or exempt fees); or Interest. Suspended business entities lose
their rights, powers, and privileges to conduct business in California.289 The Orange County
District Attorney alleged the Franchise Tax Board revoked DaVinci and DVBs ability to
conduct business in California because the firms failed to pay all the required taxes or fees.290
Documents produced by DVB show that, despite its revocation, the firm continued to conduct
business through October 16, 2015.291
The counsel for both entities informed the Panel that DVB is a subsidiary of DaVinci
Biosciences, LLC.292 DaVinci is jointly owned and managed by [DVB Executives].293 [DVB
Executive #1] is a founding member of both DaVinci and DVB.294 The other founders of both
DaVinci and DVB are [DVB Executives #2 and #3].295 All are related.296
d) History of the Panels Interactions with DaVinci and DVB
The Panel sent a December 18, 2015 document request letter to DVB that asked for,
among other items, a list of all entities from which it procured fetal tissue and to which is sold or
donated fetal tissue, an organization chart, all communications that direct DVB personnel to
procure fetal tissue, and all accounting and banking records.297
DVB responded in a January 29, 2016 letter in which it produced only information about
where it procured fetal tissue, a list of entities to which it sold or donated fetal tissue, and an
organization chart.298 DVB in that same letter agreed to produce on a rolling basis all
communications that direct its personnel to procure fetal tissue, all accounting records, all
specific requests for fetal tissue made by any entity (including order lists, billing records, and
payment records), documents related to equipment (including maintenance costs and
depreciation), an inventory of all fetal tissue procured or sold, and its banking records.299
On May 5, 2016, the Panel issued a subpoena to DVB that required the production by
May 23, 2016, of all the documents requested in the December 18, 2015, letter, as well as
detailed accounting records, copies of invoices that related to the sale of fetal tissues or cell lines
derived therefrom, and communications or documents related to Institutional Review Board
289

State of California Franchise Tax Board website, https://www.ftb.ca.gov/businesses/faq/742.shtml.

Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
291
Invoices produced to the Panel by DaVinci Biologics, LLC (May 27, 2016).
292
See Letter from R. Joseph Burby, IV, Bryan Cave LLP, to Rep. Marsha Blackburn, Chair, Select Investigative
Panel (Jan. 29, 2016).
293
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
294
Id.
295
Id.
296
Id.
297
See Letter from Rep. Marsha Blackburn, Chair, Select Investigative Panel, to Juan Jose Duran, Vice President for
Operations, DaVinci Biologics, LLC (Dec. 18, 2015).
298
See Letter from R. Joseph Burby, IV, Bryan Cave LLP, to Rep. Marsha Blackburn, Chair, Select Investigative
Panel (Jan. 29, 2016).
299
See id.
290

187

approvals.300 The subpoena did not demand the production of charitable contributions made by
DVB, its officers, or executives.301
During a May 13, 2016, telephone conference with Panel staff, DVB offered to produce
various accounting documents, with the provision that the Panels forensic accountant would
review the documents. 302 If the Panel determined that the documents were inadequate, the Panel
could request more detailed records.303 On May 18, 2016, DVB produced cost analysis and other
financial documents that it contended showed the firm lost money on fetal tissue production and
sales.304 After a forensic accounting analysis of the proposed production, the Panel found that the
documents were insufficient to determine the adequacy of the applicable federal statute.
On May 27, 2016, DVB produced to the Panel 1,711 invoices that counsel for the firm
represented covered all orders for fetal tissue.305 DVB still has not produced all communications
related to the procurement or sale of fetal tissue, accounting memoranda, chart of accounts, tax
returns, bank statements, orders for fetal tissue, and communications and documents that relate
or refer to Institutional Review Board approvals.
In late May 2016, the Panel discovered an online copy of the Planned Parenthood Orange
and San Bernardino Counties (PPOSBC) 2008-2009 program report which listed DaVinci as
having donated between $1,000 and $2,499 to the Planned Parenthood affiliate.306 Panel staff
held a May 26, 2016, telephone conference with DVB counsel to request information on DVBs
charitable contributions to PPOSBC from January 1, 2010, through May 26, 2016. In a June 7,
2016, email to staff, DVBs counsel represented that DVB:
only made two donations to PPOSBC during this time period, which
together totaled only $380. The donations were made by purchasing
a ticket (at a price of $190) to attend PPOSBCs annual fundraising
luncheon. We trust youll find that these donations were nominal
and hardly represented some sort of effort by DV Biologics to
covertly pay PPOSBC for fetal tissue donations it received.307
Panel staff and DVB counsel exchanged emails on June 7, 2016, in which the Panel
requested additional information and documentation.308 In a June 9, 2016 email to the Panel,
DVB counsel produced records that show DVB officials donated a total of $3,030 to PPOSBC,
300

Subpoena to DV Biologics, LLC (May 5, 2016), Exhibit 5.29.

Id.
302
Telephone conference between Panel staff and R. Joseph Burby, IV, Bryan Cave LLP (May 13, 2016).
303
See Letter from R. Joseph Burby, IV, Bryan Cave LLP, to Rep. Marsha Blackburn, Chair, Select Investigative
Panel (Jan. 29, 2016). Telephone conference between Panel staff and R. Joseph Burby, IV, Bryan Cave LLP (May
13, 2016).
304
See Letter from Michael R. Tein, co-counsel to DVB, to Panel staff (May 16, 2016).
305
See Email from Matthew Simmons, Lewis Tein PL, to Panel staff (May 27, 2016).
306
See Planned Parenthood of Orange and San Bernardino Counties, Program Report 2008-2009: I Am Building
Healthy Communities, at 12.
307
See Email from R. Joseph Burby, IV, Bryan Cave LLP, to Panel staff (June 7, 2016).
308
See Email from Panel staff to R. Joseph Burby, IV, Bryan Cave LLP (June 7, 2016, 5:09 p.m.); Email from R.
Joseph Burby, IV, Bryan Cave, LLP, to Panel staff (June 7, 2016, 5:44 p.m).
301

188

not the $380 he had earlier represented.309 In his email, DVB counsel acknowledged these
records are outside the scope of the Committees [sic] subpoena, but our client has nevertheless
elected to voluntarily provide them to you.310 On August 10, 2016, DVBs vice president for
operations sent a letter to Panel staff changing the amount that DVB, its officers, directors, and
employees donated to PPOSBC from $3,030 to $3,620.311
On October 11, 2016, the Orange County, California District Attorney filed a lawsuit
against DaVinci, DVB, and their corporate officers that alleged the entities violated 42 289g-2,
and Section 125320 of the California Health and Safety Code that likewise bars the sale of fetal
tissue for valuable consideration.312 The lawsuit alleged that DaVinci and DVB obtained
aborted fetus donations from Planned Parenthood [Orange and San Bernardino Counties] and
turned those donations into a profit-driven business, through which the companies wound up
earning hundreds of thousands of dollars in revenue.313
8. Business Model of DaVinci and DVB
a) Marketing Activities
DVB began commercial operations in May 2009, without a market strategy. A few
months later, the firm launched its first marketing campaign,314 which stated:
The marketing challenge for [2009-2010] will be to introduce our
products in a politically conscious way given that the material is
both human and in some cases pre-natal derived . . . . The challenge
will be to form a sales tactic team, infiltrate markets . . . to change
existing buyers outlook and purchasing behaviors . . . [and to make]
human cell-derived products well understood and appear worthy of
any additional cost to purchase.315
Both DaVinci and DVB hired an outside marketing consultant to develop marketing
materials, including a catalog, to support their sales effort. The 2010 catalog was posted on the
companys website and was sent to various sales leads in an effort to drive sales. The catalogue
advertised numerous fetal tissue products, as part of DVBs LIFEbank brand. The fetal tissues
and cells that were listed for sale on the first catalogue included heart, brain, lungs, kidneys,
liver, large, intestines, small intestines, skin, skeletal muscle, and bones.316

309

See Email from Joseph R. Burby, IV, Bryan Cave LLP, to Panel staff (June 9, 2016).
See Email from Joseph R. Burby, IV, Bryan Cave, to Panel staff (June 9, 2016).
311
See Letter from [DVB Vice President of Operations] to Panel staff (Aug. 10, 2016).
312
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
313
Id..
314
Id.
315
Id.
316
Id.
310

189

The first online catalogue advertised prices in a range as low as $40/vial for Total RNA
cells from several fetal parts to as high as $1,100/vial for fetal brain cells. Most products were
priced somewhere in the middle of this range ($300-$375/vial for fetal lung cells; $300-$450/vial
for fetal kidney cells; $500-$700/vial for fetal heart cells; and $250-$700/vial for fetal liver
cells).317 The current DVB online catalog allows researchers to select from among 338 different
types of cells and add the desired product to their cart.318 As with the original catalogue, the
prices vary dramatically.319
DVBs current website catalogue states that customers can [O]rder anytime, 24 hours a
day, 365 days a year by email or fax. If your order arrives outside our normal business hours, it
will be quickly processed at the beginning of the next business day.320 All orders to North
America are shipped from DV Biologics headquarters in Southern California and freight is prepaid and added to your invoice as a separate item unless customers references their own separate
shipping account and vendor.321 International orders are shipped from DV Biologics
headquarters in Southern California every Monday unless specially requested to be shipped on
another date.322
In late 2011, DaVinci and DVB created a business and marketing plan for the next three
years. The plan laid out DaVinci and DVBs three-year goals: to infiltrate the cell-based market,
be a major competitor in the cell-based therapies and tools market for improving health and
quality of life, and provide a healthy and conservative balance sheet.323 The plans objective
was to develop the business units of DaVinci and DVB into revenue and value generating
subsidiaries.324 To achieve that, the plan called for hiring a commercial representative or a
dedicated sales/marketing person, increasing the amount of marketing and the number of
distributors throughout the world and tak[ing] advantage of the internet, distributors, newsletters,
educational presentations, and direct marketing/sales.325
The plan also called for penetrating the local American market by securing a United
States distributorship agreement.326 The business and marketing plan required DVB to market
no less than 10 new products yearly.327 The driving force behind the business and marketing
plan was to increase sales yearly by no less than 30% each year for the next 3 years . . .328

317

Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
318
DV Biologics, LLC, LIFEbank Products, http://www.dvbiologics.com/products, Exhibit 5.30.
319
Id.
320
DV Biologics, LLC, Website, http://www.dvbiologics.com/ordering-information, Exhibit 5.31.
321
Id.
322
Id.
323
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
324
Id.
325
Id.
326
Id.
327
Id.
328
Id.

190

After a regional sales manager was hired in early 2013, DaVinci and DVB started a 2013
Sales Launch Plan to further increase sales. The primary objective of [the] plan was to help
DVB meet or exceed its bottom-line goals & objectives, including a goal to [g]enerate
$550,000 in gross revenue by the end of 2013.329
The 2013 sales plan also called for improved selling techniques, the retention of two
additional sales managers, and a focus on the sales of the hottest selling products, which
included, among others, the firms fetal tissue cell lines. In addition, the sales plan expected that
the sales team will go above & beyond what is generally expected, by heavy prospecting to
generate leads and secure sales.330
The Orange County District Attorney alleged that, starting in 2012 and for years after
under updated marketing and sales plans, both DaVinci and DVB management consistently
pushed staff to sell more product.331
As part of its marketing and sales efforts, DVB offered customer discounts.332 The
Orange County District Attorney lawsuit noted DaVinci and DVB offered numerous discounts,
including distributor discounts (20-30%); first time buyer discounts (10-15%); and bulk purchase
discounts (sometimes as high as 50%). The company also regularly offered sales pricing
promotions, including, for example, a 25% off summer sale and 25% off fall promotion in
2013.333
Documents DVB produced to the Panel demonstrate that the District Attorney was
correct: Customers who sought a discount had to submit a credit application, that included
business references.334 A DVB operations assistant then contacted the business references and
asked them how long the customer has been doing business with the reference, what was their
credit line, and whether they always paid on time.335 If the customer or distributor had three
favorable references, they received up a $5,000 maximum credit line upon approval of DVBs
vice president for operations. The vice presidents of operations and sales could provide larger
unspecified credit lines.336 If a customer who received a discount paid within 10 days of the
invoice date, they could receive an additional early payment discount of 1.5%.337
In addition, a tradeshow ad produced by DVB to the Panel shows that attendees of the
University of California Riverside Biotechnology Vendor Showcase received a 20% discount
329

Id.
Id.
331
Id.
332
DV Biologics, LLC, Guidelines for Payments and Discounts, (Feb. 12, 2015) [DVB_0000001400000018],
Exhibit 5.32.
333
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
334
DV Biologics, LLC, Guidelines for Payments and Discounts, (Feb. 12, 2015) [DVB_0000001400000018],
Exhibit 5.32.
335
Id.
336
Id.
337
Id.
330

191

off their first order! [sic]338 DVB also offered customers 10% of their next order if they
referred a colleague to DVB.339 Invoices produced by DVB to the Panel show the firm also
offered, in several instances, discounts of 50%, significant special discounts, complimentary
evaluation samples, lower prices for distributors, a 25% holiday discount, and a 15% discount off
first orders.340
b) DaVinci and DVBs Relationship with Planned Parenthood of Orange and San
Bernardino Counties
Both entities received aborted fetal tissue from the same source: Counsel for DaVinci and
DVB told the Panel, DVB received fetal tissue exclusively from its parent company, DaVinci.
DaVinci itself received fetal tissue exclusively from Planned Parenthood of Orange and San
Bernardino Counties [PPOSBC]. DaVinci claimed it did not pay any money to Planned
Parenthood for the donated tissue.341
Planned Parenthood Federation of America (PPFA) told investigators from the Energy
and Commerce Committee that PPOSBC entered into an agreement [with DVB] in September
2008 to facilitate fetal tissue donation by its patients. The affiliate last facilitated tissue donation
on June 5, 2015. The program was suspended because [DVB]s laboratory was undergoing
renovations.342 PPFA also revealed to an earlier investigation that PPOSBC was the only
Planned Parenthood affiliate that has facilitated tissue donation directly to a biosciences
company.343
A September 23, 2008, contractual agreement between DVB and PPOSBC shows that the
firm provided PPOSBC with a sterile container, including storage media, for each fetal tissue
specimen the Planned Parenthood affiliate obtained.344 On each day DVB was scheduled to
obtain fetal tissue, PPOSBC workers would, following retrieval, store each [fetal tissue]
Specimen in a separate container and notify DVBs designated contact . . . that Specimen is
ready for pick-up . . . .345

338

DV Biologics, LLC, Biotechnology Tradeshow Ad, undated [DVB_00000289], Exhibit 5.33.

DV Biologics, LLC, Customer Referral Program, Sept. 5, 2014, at 6 [DVB_00000254], Exhibit 5.34.
340
See Invoices produced to the Panel by DaVinci Biologics, LLC (May 27, 2016).
341
See Letter from Joseph R. Burby, IV, Bryan Cave LLP, to Rep. Marsha Blackburn, Chair, Select Investigative
Panel 3 (Jan. 29, 2016).
342
Planned Parenthood Federation of America, Follow-up Questions Dated August 20, 2015: U.S. House of
Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, at 2
[PPFA-HOU_E&C-0000162 PPFA-HOU_E&C-000169], Exhibit 5.35.
343
Planned Parenthood Federation of America, Follow-up Questions Dated August 20, 2015: U.S. House of
Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations [PPFAHOU_E&C-0000259 PPFA-HOU_E&C-000262], Exhibit 5.36.
344
Specimen Donation Agreement between DaVinci Biosciences, LLC, and Planned Parenthood of Orange and San
Bernardino Counties (Sept. 23, 2008) [DVB_00001613 DVB00001622], Exhibit 5.37.
345
Planned Parenthood Federation of America, Follow-up Questions Dated August 20, 2015: U.S. House of
Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations [PPFAHOU_E&C-0000259 PPFA-HOU_E&C-000262], Exhibit 5.36.
339

192

The 2008-2009 program report of PPOSBC listed DaVinci as having donated between
$1,000 and $2,499 to the Planned Parenthood affiliate.346 DVBs contract with PPOSBC is dated
September 23, 2008.347 Documents produced by DVB to the Panel show officials with the firm
donated $2,190 to PPOSBC during 2008 alone, including four separate $500 charitable
donation[s] on April 24, 2008.348 That date is significant because it not only predates by nearly
five months DVBs contract with PPOSBC, but also because invoices produced by DVB to the
Panel show that less than one year later, on April 1, 2009, the firm first transferred human fetal
tissue to a customer.349 In 2009, DVB donated another $500 to PPBOSBC.350
DVBs attorney represented that the individuals responsible for these donations have not
worked at DV Biologics since approximately 2011. The company underwent a significant
change in management at that time.351 [DVB Executive #1], who contributed $2,500 to
PPOSBC before the PPOSBC contract was signed, was named by the Orange County District
Attorney as DaVincis manager and chief executive officer.352 However, in 2012, DVB donated
$380 more in two separate $190 donations to PPBOSCB.353 It is unclear why DVB made the two
donations if the individuals responsible for the earlier donations had left, along with key
management officials.
Documents produced by other firms in the fetal tissue industry to the Panel pursuant to
subpoenas demonstrate that the industry norm is for companies, both for-profit or non-profit, to
pay California-based abortion clinics for fetal tissue. For example, StemExpress, LLC, another
for-profit tissue procurement firm, paid Planned Parenthood affiliates in California an average of
$50 per-specimen obtained.354 Advanced Bioscience Resources, Inc., a non-profit tissue
procurement business, paid facility fees of $55 or $60 per month (depending upon the year) to
the Planned Parenthood affiliates and clinics from which it obtained fetal tissue.355 From 2010
through 2015, StemExpress paid a total of $135,880 to California-based Planned Parenthood
affiliates for fetal tissue specimens.356 Over the same time period, Advanced Biosciences

See Planned Parenthood of Orange and San Bernardino Counties, Program Report 2008-2009: I Am Building
Healthy Communities, 12.
347
Specimen Donation Agreement between DaVinci Biosciences, LLC, and Planned Parenthood of Orange and San
Bernardino Counties (Sept. 23, 2008) [DVB_00001613DVB00001622], Exhibit 5.37.
348
DV Biologics, LLC, Transactions Detail by Account, January 1, 2007 through September 28, 2015.
349
DV Biologics, LLC, Invoice Number 1, Apr. 1, 2009.
350
DV Biologics, LLC, Transactions Detail by Account, January 1, 2007 through September 28, 2015.
351
Email from R. Joseph Bury, IV, Bryan Cave LLP, to Panel staff, June 9, 2016.
352
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
353
DV Biologics, LLC, Transactions Detail by Account, January 1, 2007 through September 29, 2015.
354
See Services Agreement between StemExpress, LLC, and Planned Parenthood Mar Monte, Apr. 1, 2010, at 1
[STEM_HOUSE.SELECT_0167STEM_HOUSE.SELECT_0169]; Services Agreement between StemExpress,
LLC, and Planned Parenthood Shasta Pacific (May 15, 2012) 1 [STEM.HOUSE.SELECT_0170
STEM.HOUSE.SELECT_0172]; Services Agreement between StemExpress, LLC, and Planned Parenthood of
Santa Barbara, Ventura & San Luis Obispo Counties 1 (Oct, 23, 2013).
355
Advanced Bioscience Resources, Inc., Statement of Facility Fees, Jan. 2010 Oct. 2015.
356
Panel analysis of invoices from Planned Parenthood Mar Monte and Planned Parenthood Shasta Pacific to Stem
Express, LLC.
346

193

Resources, Inc. paid a total of $328,225 to California-based Planned Parenthood affiliates for
fetal tissue specimens.357
c) Revenue Growth
When DVB began its commercial operations in May 2009, the company had minimal
product inventory and no marketing or sales.358 Between 2009 and 2011, sales revenues nearly
tripled.359 By 2012, DaVinci and DVBs products were valued at much greater than $4.4
million.360 An undated audit of DaVinci and DVB stated the value of the firms inventory could
be as high as $10 million.361
The Orange County District Attorney alleged that DVBs goal in 2013 was to generate
$555,000 in revenue by the end of the year.362 Those goals were slightly high: In both 2013 and
2014, the company grossed in excess of $400,000 in revenuedouble that of 2012. In 2015, the
firms continued their upward momentum and exceeded $550,000 in gross revenues.363 The
District Attorney alleged, When subtracting the cost of goods sold, DV produced a gross profit
on sales every year, except 2012.364
9. Consent & Procurement During the Abortion Procedure
Documents produced by DVB to the Panel show that PPOSCB workers performed the
following tasks:

Discussed tissue donation with women awaiting abortions;

Obtained consent from the patients to donate human fetal tissue;

Procured fetal tissue of between a gestational period of 5-20 weeks;

Stored the signed consent forms;

Collected the fetal tissue samples, washed the samples, and transferred them to a sterile
container with the gestational age written on the container; and,

357

Panel analysis of invoices from Planned Parenthood San Jose, Planned Parenthood Riverside, and Planned
Parenthood to Advanced Bioscience Resources, Inc.
358
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
359
Id.
360
Id.
361
Id.
362
Id.
363
Id.
364
Id.

194

Stored the samples on wet ice, which were transported by DVB employee(s).365

10. Post-Procedure Practices

DV employees received the fetal tissue, noting the harvest date, the pickup time, the
arrival time, the organ/tissue, gender, which employee picked up the tissue, whether the tissue
was discarded, and if so, why.366 Once the tissue was logged in, DVB employees then processed
the fetal tissue, checked it in, [i]dentified fetal organs mechanically minced and enzymatically
digested the organs, cultured the isolated cells, and, in some instances cryopreserved the cells
or cell lines at DVB.367
11. Customers that Received Fetal Tissue from DaVinci and DVB
DaVinci and DVB sold the fetal tissue to researchers, educational institutions, and
pharmaceutical companies. DaVinci focused on the research and development of cell-based
therapeutics targeting neurodegenerative and autoimmune diseases, while DVB supplied human
biological tools to academic institutions and pharmaceutical companies for research
purposes.368
Roughly half of all DVBs customers were foreign entities.369 DVBs domestic customers
were, in chronological order:

The University of Utah Cell Therapy Facility

VA Health Center - Long Beach

University of Connecticut Health Center

Cedars-Sinai Medical Center

University of Texas San Antonio

University of California Irvine Department of Radiation

Life Technologies

Cleveland Clinic

365

DaVinci Biosciences, LLC, Characterization of Human Fetal Stem Cells and Determination of Research and
Therapeutic Tool Potential, undated [DVB_00001611-0000612], Exhibit 5.38.
366
DaVinci Biosciences, LLC, Form 101, Prenatal Receiving, undated [DVB_00000062], Exhibit 5.39.
367
DaVinci Biosciences, LLC, Characterization of Human Fetal Stem Cells and Determination of Research and
Therapeutic Tool Potential, undated [DVB_00001611-0000612], Exhibit 5.38.
368
See Letter from R. Joseph Burby, IV, Bryan Cave LLP, to Rep. Marsha Blackburn, Chair, Select Investigative
Panel (Jan. 29, 2016).
369
Panel analysis of invoices produced by DaVinci Biologics, LLC.

195

City of Hope

Cellular Dynamics International

SA Biosciences Corporation

StemCell Technologies, Inc.

Omeros Corporation

University of Wisconsin Medical College

University California Merced

Procter & Gamble (Miami Valley Innovation)

Stanford University

Fisher Scientific

UNIVSION USA

B-Bridge International Inc.

iPierian, Inc.

AgenSys

Aloecorp, Inc.

Santa Cruz Biotechnology, Inc.

Zyagen

Trim-edcine

WuXi App Tech, Inc.

Tufts University

Royspec

J. David Gladstone Institutes

196

370

Applied StemCell, Inc.

Gentech

Creative Biolabs, Inc.

Baylor College of Medicine

RaNa Therapeutics, Inc.

MatTek Corporation

New York Medical Center

Tufts University Department of Biomedical Research

University of Washington

Organovo

Amira Pharmaceuticals Inc.

New York University Langone Center

University of Texas Medical Branch

National Institutes of Health

Brigham & Women's Hospital

Abbvie, Inc.

Quorum Innovations

Earth Science Tech.370

Invoices produced by DaVinci Biologics, LLC, to the Panel.

197

12. Potential Violations of Law

c) Applicable Laws
l) 42 U.S.C. 289g-2
The applicable federal law on fetal tissue is 42 U.S.C. 289g-2(a), which states It shall
be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal
tissue for valuable consideration if the transfer affects interstate commerce. Under that law,
The term valuable consideration does not include reasonable payments associated with the
transportation, implantation, processing, preservation, quality control, or storage of human fetal
tissue.371 Human fetal tissue is defined broadly to include any tissue or cells
obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a
stillbirth.372
ii) California Health and Safety Code Section 125320
The California Health and Safety Code contains virtually identical language as 42 U.S.C.
289g-2. That law states that:
(d) A person may not knowingly, for valuable consideration, purchase
or sell embryonic or cadaveric fetal tissue for research purposes
pursuant to this chapter.
(e) For purposes of this section, valuable consideration does not
include reasonable payment for the removal, processing, disposal,
preservation, quality control, storage, transplantation, or
implantation of a part.
(f) Embryonic or cadaveric fetal tissue may be donated for research
purposes pursuant to this chapter.373
As with 42 U.S.C. 289g-l(g), another provision of the California Health and Safety
Code also broadly defines tissue to mean a human cell, group of cells, including the cornea,
sclera, or vitreous humor and other segments of, or the whole eye, bones, skin, arteries, sperm,
blood, other fluids, and any other portion of a human body . . . .374
iii) California Revenue and Tax Code
A provision of the California Revenue and Tax Code states that:

371

42 U.S.C. 289g-2(e)(3)
42 U.S.C. 289g-l(g).
373
Cal. Health & Safety Code 125320.
374
Cal. Health & Safety Code 1635(c).
372

198

[E]very retailer engaged in business in this state and making sales

of tangible personal property for storage, use, or other consumption
in this state, not exempted . . . shall, at the time of making the sales
or, if the storage, use, or other consumption of the tangible personal
property is not then taxable hereunder, at the time the storage, use,
or other consumption becomes taxable, collect the tax from the
purchaser and give to the purchaser a receipt therefor in the manner
and form prescribed by the [California State Equalization Board].375
The law defines a retailer engaged in business in California as Any retailer
maintaining, occupying, or using, permanently or temporarily, directly or indirectly, or through a
subsidiary, or agent, by whatever name called, an office, place of distribution, sales or sample
room or place, warehouse or storage place, or other place of business.376
There is an exemption for the sale of human blood and human body parts.377 DVB is not
a tissue or blood bank. Rather it sells fetal tissue cells, cell lines, and other products directly to
customers. The California State Board of Equalization (SBE) recently collected nearly $82,000
for unpaid sales taxes for a non-profit organization that saves dogs, draws blood from those dogs,
and sells the white blood cells, plasma, and red blood cells for transfusions into other canines.378
The statute defines tangible personal property as personal property which may be seen,
weighed, measured, felt, or touched, or which is in any other manner perceptible to the
senses.379 Thus, cells and cell lines are tangible personal property under the California Sales and
Use Tax.
An SBE publication states that California companies can pass along the amount of sales
tax to customers, provided the business lists a separate amount for sales tax reimbursement on its
receipts or invoices, or if the sales agreement specifically calls for the addition of sales tax
reimbursement.380 If the business includes sales tax reimbursement in its prices, companies
must inform the buyer that tax is included by making one of the following statements on a
price tag or in an advertisement: All prices of taxable items include sales tax reimbursement
computed to the nearest mill, or The price of this item includes sales tax reimbursement to the

Cal. Rev. & Tax Code 6203. A publication put out by the State Board of Equalization (SBE) states that
provision applies to corporations, individuals, Limited Liability Companies, Limited Liability Partnerships, Limited
Partnerships, partnerships, married co-owners, registered domestic partnerships, and organizations. Cal. State Bd. of
Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the Sales and Use Tax Law,
Pub. 72, May 2014, at 1.
376
Cal. State Bd. of Equalization, Laws, Regulations & Annotations, Sales and Use Tax Law, Chapter 3. The Tax,
https://www.boe.ca.gov/lawguides/business/current/btlg/vol1/sutl/6203.html.
377
Cal. Rev. & Tax Code 33 (Human whole blood, plasma, blood products, and blood derivatives, or any human
body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose.).
378
Chris Haire, Greyhound Dog Rescue Hemopet Fights to Stay Open after $82,000 Tax Bill, Orange County
Register, Oct. 10, 2016, http://www.ocregister.com/articles/blood-731674-hemopet-greyhounds.html.
379
Cal. Rev. & Tax Code 6016.
380
Cal. State Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the
Sales and Use Tax Law, Pub. 72, May 2014, at 5.
375

199

nearest mill.381 Neither of those statements are on DVBs website or in the advertisement
produced to the Panel by DVB.382
Under the California Revenue and Tax Code,
Internet sales are treated just like sales made at retail stores, by sales
representatives, over the telephone, or by mail order. If your
business is located in California, retail sales of tangible personal
property that you make over the Internet to California customers are
generally taxable unless the sales qualify for a specific tax
exemption or exclusion . . . and you are required to register for a
permit and report and pay tax to the same extent as any other retailer
in California.383
d) Findings
j) 42 U.S.C. 289g-2 & California Health and Safety Code Section 125320
The Orange County District Attorney alleged that DaVinci and DVBs costs to process
fetal tissue were minimal: a limited number of labor hours (2-9 hours per product) and that it cost
the firms an average of less than $20/vial.384
Internal company documents cited in the District Attorneys lawsuit show that DaVinci
and DVB sold fetal tissue for valuable consideration. Human Cardiomyocytes cells derived from
fetal tissue were produced at a cost including labor of $25.92 per vial; DaVinci and DVB sold it
for between $350-per vial and $700-per vial, which amounted to between $324.08 and $674.08
in profit for each vial sold (not including any profits earned on packaging and handling or other
fees).385
Human Cardiac Progenitor cells, also derived from fetal tissue, were produced at a total
cost of $62.31 per vial; the product sold for between $455 and $650-per vial, which amounted to
between $392.69 and $587.69 profit for each vial.386 Another product derived from fetal tissue,
Human Whole Liver Cells cost $18.46 per vial to produce; the vials sold for between $125 and
$200 a vial, which meant the companies made profits of between $106.54 and $181.54 for each
vial.387 Human CD34 Positive Cells, also derived from fetal liver tissue donations, cost $126.17

See Cal. State Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the
Sales and Use Tax Law, Pub. 72, May 2014.
382
DVB Advertisement, Exhibit 5.33.
383
Cal. State Bd. of Equalization, Publication 109 Internet Sales, https://www.boe.ca.gov/formspubs/pub109/.
384
Complaint, People v. DV Biologics, LLC, et al., 201600880665, (Cal. Super. Ct., Orange County, Oct. 11, 2016),
Exhibit 5.28.
385
Id.
386
Id.
387
Id.
381

200

per vial to produce; it sold for between $225 and $360 for each viala profit of between $98.83
and $233.83 per vial.388
Stomach cells, also derived from fetal tissue, sold for between $210 and $240 per vial. It
cost DaVinci and DVB $18.46 to produce ten vials. Thus, the firms earned a profit of between
$191.54 and $221.54 per vial.389 Two other products that came from fetal tissue, Human Small
Intestine Cells (uncultured) and Human Large Intestine Cells were produced in ten-vial lots at a
total cost of $18.46 per viala profit of between $191.54 and $281.54 per vial.390
Another product derived from fetal tissue, Human Small Intestine Epithelial Cells, were
manufactured in 10 vials at a cost of $35.91 per vial; DaVinci and DVB sold it for between
$297.50 and $700 a vial, which amounted to a per-vial profit of between $261.59 and $664.09.391
ii)

California Revenue and Tax Code

As previously noted, DVB sold its products through the Internet. It should, therefore,
have collected tax on sales made to California customers. Seventeen invoices produced by DVB
show the firm did not charge tax to California-based clients.392 The invoices are listed in the
chart below:
CUSTOMER DATE

INVOICE
NUMBER

AMOUNT
OF SALE

SALES TAX
CHARGED

Life
Technologies

Feb. 9, 2010

017

$1,500

Life
Technologies

Jun. 29, 2010

042

$2,425

Life
Technologies

Jun. 29, 2010

043

$2,390

Life
Technologies

Aug. 3, 2010

053

$ 631

Life
Technologies

Sep. 7, 2010

064

$2,415

388

Id.
Id.
390
Id.
391
Id.
392
Invoices from DV Biologics, LLC, to Life Technologies, Exhibit 5.40.
389

201

Life
Technologies

Oct. 6, 2010

073

$1,078

Applied
Oct. 31, 2012
StemCell, Inc.

387

$ 450

Applied
May 16,
StemCell, Inc. 2013

504

$1,214

Applied
Jun. 4, 2013
StemCell, Inc.

517

$ 152.99

Applied
Sep. 9, 2013
StemCell, Inc.

600

82

Applied
Oct. 1, 2013
StemCell, Inc.

618

$ 450

Applied
Oct. 7, 2013
StemCell, Inc.

622

$1,570

Applied
Mar. 6, 2014
StemCell, Inc.

754

$4,016.99

Applied
Jun. 30, 2014
StemCell, Inc.

837

$ 218

Applied
Aug. 13,
StemCell, Inc. 2014

869

$ 592.99

Applied
Aug. 18,
StemCell, Inc. 2014

871

$ 856.99

$1,250

Applied
Feb. 24, 2015 1077
StemCell, Inc.

13. Conclusion
The Panel referred DVBs potential violations of the California Revenue and Tax Code to the
Orange County District Attorney. The Panel referred DVBs potential violation of Title U.S.C.
289g-2 to the United States Department of Justice.

202

C. Novogenix Laboratories, LLC: A Case Study

10. Summary
The Panel has uncovered evidence that Novogenix Laboratories, LLC (Novogenix) may
have violated laws, including 42 289g-2, Cal. Health & Safety Code 125320(a), provisions of
the California Tax Revenue and Tax Code, and regulations promulgated by the U.S. Department
of Health and Human Services.
a) Background of Novogenix
Novogenix was founded as a for-profit corporation with the California Secretary of State
on February 24, 2010, by [Founder and Executive Director].393 As of October 2015, Novogenix
went out of business.394 Documents produced by the U.S. Food and Drug Administration (FDA)
to the Panel show that Novogenix may not have registered with the FDA.395 Novogenix claimed
its work with fetal tissue and stem cells derived from fetal tissue was exclusively for the
purposes of scientific research, and was not used for therapeutic or transplantation purposes.396
If true, Novogenix was not regulated by the FDA. [Founder and Executive Director], owner of
the company told the investigators from the Committee on Energy and Commerce inquiry into
the fetal industry that, during the time Novogenix was operating 70%-80% of its business was
selling services related to fetal tissue.397 Those services included the procurement of fetal tissue,
the creation of stem cells from fetal tissue, and the shipment of those fetal tissues and stem cells
to scientists engaged in research.398
b) History of the Panels Interactions with Novogenix
On December 17, 2015, the Panel sent Novogenix a document request letter requesting a
list of all entities from which it procured fetal tissue, a list of all entities to which it sold or
donated fetal tissue, an organization chart, all communications that direct its employees to
procure fetal tissue, accounting records, and all Novogenix banking records related to the
procurement, sale, donation, or distribution or shipment of fetal tissue.399
Citing its productions to preliminary congressional investigations into the fetal tissue
industry, and that the firm had stopped doing business, Novogenix initially refused to provide
393

California Secretary of State, Business Entity Detail, http://kepler.sos.ca.gov.

See Letter from Joshua A. Levy, Cunningham Levy LLP, to Rep. Fred Upton, Chairman, Committee on Energy
and Commerce 1 (Oct. 6, 2015); Letter from Joshua A. Levy, Cunningham Levy LLP, to Panel staff (Dec. 22,
2015); California Secretary of State, Business Entity Detail, http://kepler.sos.ca.gov.
395
Email from [Supervisor Consumer Safety Officer], U.S. Food and Drug Administration, to [Consumer Safety
Officer], U.S. Food and Drug Administration (Sept. 14, 2014).
396
See Letter from Joshua A. Levy, Cunningham Levy LLP, to Charles Ingbertson, Chief Counsel, Committee on
Energy and Commerce 2 (Sept. 2, 2015), Exhibit 5.4.1.
397
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42
398
Id.
399
See Letter from Rep. Marsha Blackburn, Chairman, House Select Investigative Panel, to [Founder and Executive
Director] Novogenix Laboratories, LLC (Dec. 17, 2015), Exhibit 5.4.2
394

203

any responsive documents.400 Novogenix refused to provide the names of the research
institutions to whom it supplied fetal tissue not only out of consideration for the well being [sic]
of the people working at these entities, but also out of respect for [Novogenixs] non-disclosure
agreements with its customers.401 Novogenix said it was working with dispatch to reach out
to its former customers in order to determine whether any of them would consent to our
disclosure of their names to the Select Panel.402 Over the next month, Novogenix produced to
the Panel the names of some of its customers.403
After Novogenix provided only some customers names, on April 29, 2016, the Panel
authorized a subpoena that required production of the documents first requested in the December
17, 2015, letter, including the communications with its employees, accounting documents, and
all banking records.404 Following a telephone conference with Novogenix counsel, the Panel
agreed not to serve the subpoena, if Novogenix provided the names of all its former customers
by May 31, 2016.405 Novogenix produced the names of entities that have received over 99% of
the fetal tissue that Novogenix has donated.406
To date, the Panel has not received any communications that relate to fetal tissue, as well
as any accounting or banking records. Senior law enforcement attorneys and other witnesses who
testified at the Panels April 20, 2016, hearing, The Pricing of Fetal Tissue, stated accounting
and banking documents were critical to any analysis of 289g-2.407
400

See Letter from Joshua A. Levy, Cunningham Levy Muse LLP, to Panel staff 1 (Dec. 22, 2015), Exhibit 5.4.3.
See Letter from Joshua A. Levy, Cunningham Levy Muse LLP, to Panel staff 1 (Feb. 16, 2016), Exhibit 5.4.4.
402
Id.
403
See Letter from Joshua A. Levy, Cunningham Levy Muse, LLP, to Panel staff, Feb. 24, 2015; Letter from Joshua
A. Levy, Cunningham Levy Muse, LLP, to Panel staff (Feb. 26, 2015); Letter from Joshua A. Levy, Cunningham
Levy Muse, LLP, to Panel staff (Mar. 2, 2015); Letter from Joshua A. Levy, Cunningham Levy Muse, LLP, to Panel
staff (Mar. 21, 2015).
404
Subpoena to Novogenix Laboratories, LLP, (April 29, 2016), Exhibit 5.4.5.
405
Telephone conference between Joshua A. Levy, Cunningham Levy Muse LLP, and Panel staff (May 3, 2016);
Email from Joshua A. Levy, Cunningham Levy Muse LLP, to Panel staff (May 6, 2016); Email from Joshua A.
Levy, Cunningham Levy Muse LLP, to Panel staff (May 19, 2016).
406
See Letter from Joshua A. Levy, Cunningham Levy Muse LLP, to March Bell, Staff Director and Chief Counsel,
Select Investigative Panel 2 (May 31, 2016), Exhibit 5.4.6.
407
The Pricing of Fetal Tissue: Hearing before the Select Investigative Panel of the H. Comm. on Energy and
Commerce, 114th Cong. (Apr. 20, 2016). In particular, the witnesses made the following statements when asked by
Chairman Blackburn what information the Panel should pursue:
401

Former Senior Litigation Counsel, U.S. Department of Justice - Brian Lennon:

The only element where investigation is needed, and that would include I believe
forensic accounting and analysis thereof, is whether the payments made by the
research institutions that ultimately receive the human tissue to the procurement
businesses were a valuable consideration or, alternatively, reasonable payments
associated with the specific allowable services in the statute Because the
businesses do in fact incur costs associated with these delineated services, a
forensic accounting would be essential to breaking down the companys
financials. Pricing of Fetal Tissue, unedited transcript, at 53.
Former United States Attorney- Kenneth Sukhia: I would also want to know what
communications occurred betweenother communications, email and so forth,

204

11. Novogenix Business Model

a) Marketing Activities
[Founder and Executive Director] stated that Novogenix had no formal marketing plan.
Rather, researchers reached out to Novogenix for fetal tissue needs directly to [Founder and
Executive Director], because of his reputation in the field of stem cell research.408

back and forth between those people. We would seek those items as well, and of
course the accounting records. Pricing of Fetal Tissue, unedited transcript, at 79.
Former United States Attorney Mike Norton: First of all, I would start by looking
at the videos, which I have seen. I would start by reading the forensic accounting
report by Coalfire Investigations made up of former FBI agents, which found that
the videos were credible and the redacted versions say what the longer versions
say. I would obtain the accounting records, the financial records of the abortion
clinic, of the procurement business, and, frankly, I would obtain the records of the
end user as well, and subpoena both records and witnesses from all of those
entities to flesh out the facts in this case, which I think are there. Pricing of Fetal
Tissue, unedited transcript, at 125-26.
Brian Lennon: As I said in my opening, you need a forensicif I was a
prosecutor, you have to have a forensic evaluation accounting of the procurement
business, because that is not clear from the records here. So following the money,
you have got to have the entire picture. Pricing of Fetal Tissue, unedited
transcript, at 139.
Mike Norton: I would get forensic accounting. I would get all of the financial
records. I would get the profit and loss statements, the income and expense
statements, and I would get people under oath before a grand jury. Letters are not
particularly valuable. Pricing of Fetal Tissue, unedited transcript, at 139.
Attorney Catherine Glenn Foster: There are two things that I would specifically
seek among many different documents. First of all, financial records. That is
something that must be brought to light. And, second, women of every generation
are unique human beings who can speak for themselves, but the baby body parts
profiteers have created a market in which their profits rise if they pressure and
coerce women into signing donation consent forms. Pricing of Fetal Tissue,
unedited transcript, at 140.
Attorney Fay Clayton: The second thing I would do is ask them, in each particular
case, what aspect of the actual costs does a particular clinic incur? For example,
does the clinic provide space? Does the clinic, as we have seen in your charts,
provide the blood draws which requires a technician, perhaps a nurse, materials?
Does the clinic have to do paperwork? And, if so, how much? And, therefore, how
much of the actual reasonable cost is incurred by the clinic itself as opposed to by
the procurement business? Pricing of Fetal Tissue, unedited transcript, at 138.
408
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42.

205

b) Novogenixs Relationship with Abortion Clinics

Novogenix had a contract to procure fetal tissue from Planned Parenthood Los Angeles
(PPLA). The contract provided that Novogenix would reimburse PPLA for reasonable
administrative costs associated with the identification of potential donors, as well as the
obtaining of informed consent. This amount will be $45 per donated specimen.409 Novogenixs
relationship with PPLA ended in 2015 as a direct result of the Center for Medical Progress
videos and resulting press reports.410
[Founder and Executive Director] stated that Novogenix obtained tissue from other unnamed
clinics on an ad hoc basis, but Novogenix had no contracts or written documents with those
clinics, just informal agreements.411
c) Revenue Growth
Novogenix counsel told the panel, Novogenix has not sold fetal tissue. Rather,
Novogenix contracted with a number of scientists to be reimbursed for the costs of services
performed by Novogenix . . . .412 [Founder and Executive Director] acknowledged that his
understanding of which costs are reimbursable was based on his legal understanding that
Novogenix sold services, not fetal tissue.413 When he was pressed on that point, [Founder and
Executive Director] would not answer, citing attorney-client privilege.414
The company initially set its prices at $200 for each service performed, however those
prices increased each year.415 [Founder and Executive Director] calculated that figure by adding
$50 related to reagents, and $150 based on his projection of fixed costs.416 [Founder and
Executive Director] said he did not calculate how many services Novogenix would perform, how
many researchers would obtain his firms products, or the service volume.417 He explained that
the costs increased each year.418 [Founder and Executive Director]s goal was for Novogenix to
break even over time.419
409

Specimen Donation Agreement between Novogenix Laboratories, LLC, and Planned Parenthood Los Angeles
(Mar. 1, 2010), Exhibit 5.41.
410
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42; Planned Parenthood Federation of America, Response to Follow-Up Questions from the
Committee on Energy and Commerce, Subcommittee on Oversight and Investigations (Aug. 20, 2016).
411
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42.
412
Letter from Joshua A. Levy, Cunningham Levy Muse LLP, to Panel staff 1 (Dec. 22, 2015), Exhibit 5.4.3; 5.4.4.
413
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), [Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42.
414
Id.
415
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce, Sept. 3,
2015.
416
Id.
417
Id.
418
Id.
419
Id.

206

Invoices produced to the Panel by some of Novogenix customers show that it received a
total of $170,980.59 from 7 research institutions between June 2011 and December 2015.420 The
Panel cannot determine either the total number of Novogenix customers or its revenue.
The firms counsel represented that it lost a total of $160,540.03 on its fetal tissue
operations.421 Novogenix conceded that its counsel created [the expenses and revenue
document] . . .422 The Panel cannot rely on the expenses and revenue document because it was
created by counsel, and Novogenix produced no primary source accounting records. Thus, the
Panel cannot determine whether Novogenix actually lost money on its fetal tissue operations.
However, the list of expenses included an unknown amount for attorney fees.423 Such
fees are not included under the list of allowable reimbursements under 289g-2. The list of
expenses also included minimal amounts for delivery to researchers.424 Invoices produced to the
Panel by Novogenix customers show the firm charged delivery fees of up to $122.43 per
shipment,425 raising further questions about the reliability of the attorney-created cost document.
12. Consent
PPLA personnel obtained consent from patients to donate tissue from their aborted
fetuses.426 [PP Witness #1] explained that PPLA workers identified fetuses of between 9 and 16
weeks; obtained informed consent for the abortion, and informed women that PPLA had a
program for tissue donation, and, if the patient was interested, PPLA workers obtained consent to
donate fetal tissue.427
PPLA took the standard PPFA consent form,428 which stated, Research using . . . tissue
that has been aborted has been used to treat and find a cure for such diseases as diabetes,

Panel analysis of invoices produced by Childrens Hospital of Philadelphia; City of Hope; Rockefeller
University; Stanford University; the University of Connecticut Health Center; the University of California, Los
Angeles; and the University of Southern California.
421
Novogenix Laboratories, LLC, Expenses and Revenue FY 2011 FY 2015, undated. [NOVOEC-0000006
NOVOEC-0000014], Exhibit 5.43. Novogenix fiscal year ran from September through August of the following
calendar year.
422
Letter from Joshua A. Levy, Cunningham Levy LLP, to Charles Ingbertson, Chief Counsel, Committee on
Energy and Commerce 2 (Sept. 2, 2015), Exhibit 5.4.1.
423
Novogenix Laboratories, LLC, Expenses and Revenue FY 2011 FY 2015, undated. [NOVOEC-0000006
NOVOEC-0000014], Exhibit 5.43.
424
Id.
425
Panel analysis of invoices produced by Childrens Hospital of Philadelphia; City of Hope; Rockefeller
University; Stanford University; the University of Connecticut Health Center; the University of California, Los
Angeles; and the University of Southern California.
426
[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7
427
Id.
428
Id.
420

207

Parkinsons disease, Alzheimers disease, cancer, and AIDS.429 There is no cure for those
diseases.
Numerous witnesses, including senior PPFA officials, testified that the consent form is
misleading and unethical due to its contention that fetal tissue has been used to find a cure for
diabetes, Parkinsons disease, Alzheimers disease, cancer, and AIDS. [PP Witness #1] testified
that the PPFA consent form contained inaccurate statements, and that she, the person who
oversees the production of the PPFA manual that contains the consent form, was not happy that
an inaccurate document was in the manual:
Q: Have we found a cure for cancer?
A: If we had found a cure, we wouldnt be asking for tissue
donations to try to find a cure.
Q: Have we found a cure for AIDS?
A: Not that Im aware of, not yet.430
[A:] . . . To my knowledge there is no cure for AIDS. So that is
probably an inaccurate statement . . . . a consent form should not
have an incorrect statement [on it].431
When [PP Witness #1] was asked whether it bothered her that an inaccurate consent form
was in the PPFA Manual of Medical Standards and Guidelines, she testified: I guess it bothers
me. I mean, I oversee the production of the standards . . . . it doesnt make me happy that theres
something inaccurate in the manual.432
Regulations promulgated by the U.S. Department of Health and Human Services (HHS)
on informed consent states that investigators shall seek such consent only under circumstances
that provide the prospective subject with . . . sufficient opportunity to consider whether or not to
participate and that minimize the possibility of coercion or undue influence.433 The regulations
further state: When some or all of the subjects are likely to be vulnerable to coercion or undue
influence, such as . . . pregnant women . . . additional safeguards are included.434
[PP Witness #1] testified that the PPFA consent form used by Novogenix may coerce
women to donate fetal tissue. When she was asked whether the incorrect statement that fetal
tissue has found a cure for various diseases could be viewed as coercive or . . . more likely to
induce somebody to want to donate fetal tissue, [PP Witness #1] testified: I can understand
your concern that perhaps this may make someone think about donating fetal tissue because of

429

Planned Parenthood Federation of America, PPFA Manual of Medical Standards and Guidelines, Client
Information and Informed Consent, Donation of Blood and/or Aborted Pregnancy Tissue for Medical Research,
Education, or Treatment, Revised June 2011, Exhibit 5.44.
430
Unedited transcribed interview of [PP Witness #1] 130 (Oct. 6, 2016).
431
Id. at 131.
432
Id. at 134.
433
45 C.F.R. 46.116.
434
45 C.F.R. 46.111(7)(b).

208

this potential.435 She also stated that the PPFA consent forms wording may make patients more
likely to want to donate fetal tissue.436
Dr. Patrick Lee, a leading bioethicist testified at a Panel hearing that the PPFA form may
be coercive and likely is unethical.
Mr. Harris: . . . I am going to ask Dr. [Patrick] Lee, because you are
a bioethicist, is [the PFFA consent] form ethical where you tell a
patient that diabetes, Parkinsons disease, Alzheimers disease,
cancer and AIDS, that [fetal] tissue has been used to find a cure?
Past tense. It is not that we going to use it to find a cure, it has been
used to find a cure. . . . Is that unethical to ask this woman at a time
when she is making a difficult decision to say that this tissue has
been used to cure diseases when it hasnt?
Mr. [sic] Lee: No, in order to make a fully informed consent, you
have to be given accurate information.437
13. Procurement
PPLA procured the fetal tissue, as well as obtained consent. The Novogenix contract with
PPLA stated that the firm would provide PPLA with a sterile container, including storage
media, for each Specimen.438 The contract further states:
On each PPLA operating surgery day during which the retrieval of
Specimens is scheduled, PPLA will: (i) identify patients for
potential donation; (ii) obtain informed consent from patients who
agree to participate in tissue donation programs; (iii) following
pathology analysis of donated specimens [conducted by PPLA],
allow Novogenixs [sic] designated contact . . . to select material for
collection.439
[PP Doctor #1] stated that PPLA surgeons would procure the tissue. She stated if women
agreed to donate tissue, PPLA workers would flag their charts, so the surgeon would know that
she had agreed to donate fetal tissue.440 [PP Doctor #1] also stated that, if PPLA performed an
abortion on a woman who had a 12-week-old fetus, Novogenix would take all or part of the
fetus.441
435

Unedited transcribed interview of [PP Witness #1] 131-132 (Oct. 6, 2016).

Id. at 132.
437
Bioethics and Fetal Tissue: Hearing before the Select Investigative Panel of the H. Comm. on Energy and
Commerce, Mar. 2, 2016, at 140-141.
438
Specimen Donation Agreement between Novogenix Laboratories, LLC, and Planned Parenthood Los Angeles
(Mar. 1, 2010), Exhibit 5.41.
439
Id.
440
[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7.
441
Id.
436

209

[PP Doctor #1] testified that she met with the Novogenix tissue technicians before
abortions were performed to determine what type of fetal tissue the firm needed that day, and
that such meetings are helpful:
Q: Now, do you think that doctors in your position should huddle in
the morning? You say, I like to do that. It's sort of an ongoing
tense. Do you think the doctors should huddle with a tissue tech to
see what theyre procuring, is on their list that day?
A: I dont really have a feeling as to whether other doctors did. I
like to be helpful.
Q: And so you found it helpful that at least on this one day to huddle
with the tissue tech and learn what [the Novogenix tissue technician]
was searching for, what orders she had; is that right?
A: I would ask her what tissue she was looking for, yes.
Q: All right. Do you think that's a good idea for the whole fetal
tissue donation program, that doctors and the tissue techs huddle
each morning to discuss what theyre going to try and procure that
day?
A: I think it could be helpful.442
14. Post-Procurement Practices
[PP Doctor #1] stated that, after the abortions were performed and PPLA surgeons
procured the fetal tissue, a Novogenix technician would take the tissue to the firms facility.443
Novogenix processed the tissue. This generally involved methods to isolate specific cells,
generate a single cell suspension from a parent tissue, machine the cell to allow for the
simultaneous separation into 4-6 populations of cells based on the protein expression on the
surface of the cells.444
[Founder and Executive Director] stated that there were two basic post-procurement
procedures: In the first, fetal tissue would be collected at the clinics by Novogenix personnel,
who would take the specimens back to the laboratory; the firm would freeze the tissue with
various chemical fixatives, which preserves the cells; after that step was completed, workers
would wash the chemicals out of the material; prepare it for shipping, which included the
dissection of the tissues into thin slices; and ship the finished product to the researcher. The
second method involved fetal tissue that already had been isolated under the first method. The
isolated cells would be stored on-site at Novogenix, double-layered to preserve it, prepared for
shipment, and shipped once a researcher requested those particular cells.445

442

Unedited transcribed interview of [PP Witness #1] 142 (Oct. 6, 2016).

[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7.
444
[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42.
445
Id.
443

210

Because Novogenix did not produce any primary source accounting records, the Panel
cannot determine many of the firms costs. Invoices produced to the Panel by a number of
leading research institutions show that Novogenix charged some of its customers for what the
firm called services, as well as shipping. Those costs varied. Due to the dearth of any accounting
records, the Panel cannot determine what caused those variations.
15. Clinics
Novogenix received tissue from two PPLA clinics and an unknown number of unnamed
clinics.446 The firm signed its contract with the Planned Parenthood affiliate in 2010, but tissue
donations started sometime in 2011 and ended in July 2015.447
[PP Doctor #1] stated that PPLAs contract with Novogenix was approved by PPFAs
medical division.448 That statement directly contradicts the testimony of [PP Witness #1] who
testified that her department did not oversee fetal tissue donation contracts between affiliates and
outside entities.449
b) Payments received by clinic
Under its contract with PPLA, Novogenix paid the PPFA affiliate $45 per donated
specimen. The revenue documents created by the firms counsel indicate that the between 2011
and July 2015, the firm paid PPLA a total of $52,965. As previously noted, because Novogenix
did not provide primary source materials, the Panel cannot verify whether that figure is accurate.
[PP Doctor #1] stated that she did [a] rough calculation of what the costs [to PPLA for
consent of patients and the procurement of fetal tissue] before she agreed to Novogenixs
proposed $45 per specimen proposal. [PP Doctor #1] said she did not employ anyone to do an
audit or retain an independent outside auditor, rather she consulted other PPFA affiliates, looked
at the staff time involved in the following: triage; discussions with patients on fetal tissue
donation; consent; her negotiations with Novogenix; and parking spaces.450
The Panel is troubled by [PP Doctor #1]s statements. None of the costs she cited are
reimbursable under federal law.451 In addition, a memorandum from PPFAs in-house counsel to
all affiliate medical directors required that affiliates who participate in fetal tissue donation
programs either accept no reimbursement or hire an independent auditor to calculate the
affiliates costs.452 [PP Doctor #1] stated that, at the time PPLA entered into its contract with
446

[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015).
447
Id.
448
[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7.
449
Unedited transcribed interview of [PP Witness #1] 145 (Oct. 6, 2016).
450
[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7.
451
42 U.S.C. 289g-2(e)(3).
452
Memorandum from [PPFA Lawyer], et al. to Affiliate Chief Executives, Affiliate Medical Directors, Patient
Service Directors, Re: Federal Regulations for Aborted Pregnancy Tissue Donation Programs (Apr. 4, 2001) [PPFAHOU_E&C_00148PPF-HOU_E&C-000150], Exhibit 5.45.

211

Novogenix, she knew they had received the memorandum and was aware of it floating around
in [her] head.453 PPLAs blatant disregard for the memo on reimbursement for the cost of fetal
tissue donation is the rule rather than the exception at PPFA affiliates (see Planned Parenthood
section for a more detailed discussion on this issue).
16. Customers that Received Fetal Tissue from Novogenix
Novogenix received $170,980.59 from 7 research institutions between June 2011 and
December 2015.454 The Panel cannot determine the full universe of Novogenixs customers, or
Novogenix total revenue. Below is a list of Novogenixs known customers, and the amounts the
customers paid the firm.
CLIENT

TOTAL PAID

University of Southern California

$100,995.89

University of California, Los Angeles

$ 58,299.89

City of Hope

6,625.60

University of Connecticut Health Center

2,138.56

Stanford University

1,000.00

Childrens Hospital of Philadelphia

1,000.00

Rockefeller University

960.65

17. Potential Violations of Law

c) Applicable Laws & Regulations
Novogenix was under not only a legal but also a contractual obligation to obey all laws:
A provision of its contract with PPLA stipulated that Novogenix agrees to conduct cell and
stem cell research in compliance with all applicable federal and state laws.455

453

[PP Doctor #1] briefing before the Committee on Energy and Commerce (Sept. 18, 2015), Exhibit 5.4.7.
Panel analysis of invoices produced by Childrens Hospital of Philadelphia; City of Hope; Rockefeller
University; Stanford University; the University of Connecticut Health Center; the University of California, Los
Angeles; and the University of Southern California.
455
Specimen Donation Agreement between Novogenix Laboratories, LLC, and Planned Parenthood Los Angeles
(Mar. 1, 2010), Exhibit 5.41.
454

212

i) 42 U.S.C. 289g -2
The applicable federal law on fetal tissue is 42 U.S.C. 289g-2(a), which states, It shall
be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal
tissue for valuable consideration if the transfer affects interstate commerce. Under that law,
The term valuable consideration does not include reasonable payments associated with the
transportation, implantation, processing, preservation, quality control, or storage of human fetal
tissue.456 Human fetal tissue is defined broadly to include any tissue or cells obtained from a
dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.457
ii) California Health and Safety Code Section 125320
The California Health and Safety Code contains virtually identical language to 42 U.S.C.
289g-2. That law states that:
(g) A person may not knowingly, for valuable consideration, purchase
or sell embryonic or cadaveric fetal tissue for research purposes
pursuant to this chapter.
(h) For purposes of this section, valuable consideration does not
include reasonable payment for the removal, processing, disposal,
preservation, quality control, storage, transplantation, or
implantation of a part.
(i) Embryonic or cadaveric fetal tissue may be donated for research
purposes pursuant to this chapter.458
As with 42 U.S.C. 289g-l(g), another provision of the California Health and Safety
Code also broadly defines tissue to mean a human cell, group of cells, including the cornea,
sclera, or vitreous humor and other segments of, or the whole eye, bones, skin, arteries, sperm,
blood, other fluids, and any other portion of a human body . . ."459
iii) HHS Regulations on Informed Consent
HHS requires investigators to obtain informed consent from each human being used as a
research subject.460 The basic elements of informed consent include the following information:
(1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subjects

456

42 U.S.C. 289g-2(e)(3)
42 U.S.C. 289g-l(g).
458
Cal. Health & Safety Code 125320.
459
Cal. Health & Safety Code 1635(c).
460
45 C.F.R. 46 116.
457

213

participation, a description of the procedures to be followed, and

identification of any procedures which are experimental; . . . [and]
(2) A description of any benefits to the subject or to others which may
reasonably be expected from the research . . .461
Federal regulations promulgated by HHS requires investigators to obtain informed
consent from each human being used as a research subject.462 There are eight basic elements of
informed consent which, under the Common Rule, shall be provided to each subject:
1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subjects
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental;
2) A description of any reasonably foreseeable risks or discomforts to
the subject;
3) A description of any benefits to the subject or to others which may
reasonably be expected from the research;
4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;
5) A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained;
6) For research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained;
7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects rights, and
whom to contact in the event of a research-related injury to the
subject; and
8) A statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is
otherwise entitled, and the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is
otherwise entitled.463
461

Id.
45 C.F.R. 46.116.
463
Id.
462

214

iv) HHS Regulations on Institutional Review Boards (IRBs)

HHS regulations require IRBs to prepare and maintain adequate documentation of its
activities, including:
(1) Copies of all research proposals reviewed, scientific evaluations,
if any, that accompany the proposals, approved sample consent
documents, progress reports submitted by investigators, and reports
of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote
on these actions including the number of members voting for,
against, and abstaining; the basis for requiring changes in or
disapproving research; and a written summary of the discussion of
controverted issues and their resolution.
(3) Records of continuing review activities. [and]
(4) Copies of all correspondence between the IRB and the
investigators.464
Those regulations only cover clinical investigations that support applications for
research or marketing permits for products regulated by the Food and Drug
Administration, including foods, including dietary supplements, that bear a nutrient
content claim or a health claim, infant formulas, food and color additives, drugs for
human use, medical devices for human use, biological products for human use, and
electronic products.465 It is unclear whether any of the fetal tissue procured by
Novogenix was used for any purpose covered by the regulations.
v) California Revenue and Tax Code
A provision of the California Revenue and Tax Code that states:
[E]very retailer engaged in business in this state and making sales
of tangible personal property for storage, use, or other consumption
in this state, not exempted . . . shall, at the time of making the sales
or, if the storage, use, or other consumption of the tangible personal
property is not then taxable hereunder, at the time the storage, use,
or other consumption becomes taxable, collect the tax from the
purchaser and give to the purchaser a receipt therefore in the manner
and form prescribed by the [California State Equalization Board].466
464

45 C.F.R. 46.115(a).
21 C.F.R. 56.101(a).
466
Cal. Rev. & Tax Code 6203. A publication put out by the State Board of Equalization (SBE) states that
provision applies to corporations, individuals, Limited Liability Companies, Limited Liability Partnerships, Limited
Partnerships, partnerships, married co-owners, registered domestic partnerships, and organizations. Cal. State Bd. of
465

215

The law defines a retailer engaged in business in California as Any retailer

maintaining, occupying, or using, permanently or temporarily, directly or indirectly, or through a
subsidiary, or agent, by whatever name called, an office, place of distribution, sales or sample
room or place, warehouse or storage place, or other place of business.467
There is an exemption for the sale of human blood and human body parts.468 However,
Novogenix was not a tissue or blood bank. Rather it effectively sold fetal tissue cells, cell lines,
and other products directly to customers. The California State Board of Equalization (SBE)
recently collected nearly $82,000 for unpaid sales taxes for a non-profit organization that saves
dogs, draws blood from those dogs, and sells the white blood cells, plasma, and red blood cells
for transfusions into other canines.469
The statute defines tangible personal property as personal property which may be seen,
weighed, measured, felt, or touched, or which is in any other manner perceptible to the
senses.470 Thus, cells and cell lines are tangible personal property under the California Sales and
Use Tax.
An SBE publication states that California companies can pass along the amount of sales
tax to customers, provided the business lists a separate amount for sales tax reimbursement on its
receipts or invoices, or if the sales agreement specifically calls for the addition of sales tax
reimbursement.471 If the business includes sales tax reimbursement in its prices, companies
must inform the buyer that tax is included by making one of the following statements on a
price tag or in an advertisement: All prices of taxable items include sales tax reimbursement
computed to the nearest mill, or The price of this item includes sales tax reimbursement to the
nearest mill.472 It is unclear whether Novogenixs contracts with its customers included those
statements.
d) Findings
j) 42 U.S.C. 289g-2 & California Health and Safety Code Section 125320
The Panels investigation finds reason to believe that Novogenix may have violated 42
U.S.C. 289g-2 and Cal. Health & Safety Code 125320(a). The list of attorney-created
Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the Sales and Use Tax Law,
Pub. 72, May 2014, at 1.
467
Cal. State Bd. of Equalization, Laws, Regulations & Annotations, Sales and Use Tax Law, Chapter 3. The Tax,
https://www.boe.ca.gov/lawguides/business/current/btlg/vol1/sutl/6203.html.
468
Cal. Rev. & Tax Code 33 (Human whole blood, plasma, blood products, and blood derivatives, or any human
body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose.).
469
Chris Haire, Greyhound Dog Rescue Hemopet Fights to Stay Open after $82,000 Tax Bill, Orange County
Register, Oct. 10, 2016, http://www.ocregister.com/articles/blood-731674-hemopet-greyhounds.html.
470
Cal. Rev. & Tax Code 6016.
471
Cal. State Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the
Sales and Use Tax Law, Pub. 72, May 2014, at 5.
472
See Cal. State Bd. of Equalization, Your California Sellers Permit: Your Rights and Responsibilities under the
Sales and Use Tax Law, Pub. 72, May 2014,

216

Novogenix expenses included an unknown amount for attorney fees.473 Such fees are not
included under the list of allowable reimbursements under 289g-2. The list of expenses also
included minimal amounts for delivery to researchers.474 Invoices produced to the Panel by
Novogenix customers show the firm charged delivery fees of up to $122.43 per shipment.475 The
Panel questions whether that apparent contradiction indicates that Novogenix charged its
customers more for transportation than it cost the firm.
ii) HHS Regulations on Informed Consent
Statements by [PP Witness #1] and documents produced by PPFA to the Panel indicate
that Novogenix did not follow the HHS regulations on informed consent. The PPFA form the
firm used to obtain consent to donate fetal tissue states:
Research using donated tissue and blood is currently underway to
uncover the causes of and ultimately find cures for things like: Heart
Disease, Diabetes, Parkinson's Disease, Sickle Cell Anemia,
Leukemia, Lymphoma, Cancer, Spinal Cord Disease, and more.
. . . The benefits of consenting to donation today include furthering
medical research in finding cures for disease like diabetes, leukemia,
lymphoma, Parkinson's disease and more.476
That consent form specifically does not conform to the requirements for informed
consent mandated under 45 C.F.R. 46.116. Witnesses at a Panel hearing agreed that the PPFA
form may not comply with the HHS regulations on informed consent.477
The requirements for informed consent further state that investigators shall seek such
consent only under circumstances that provide the prospective subject with . . . sufficient
opportunity to consider whether or not to participate and that minimize the possibility of
coercion or undue influence.478

473

[Founder and Executive Director] Novogenix, briefing before Committee on Energy and Commerce (Sept. 3,
2015), Exhibit 5.42.
474
Id.
475
Panel analysis of invoices produced by Novogenix Laboratories, LLC.
476
Planned Parenthood Federation of America, PPFA Manual of Medical Standards and Guidelines, Client
Information and Informed Consent, Donation of Blood and/or Aborted Pregnancy Tissue for Medical Research,
Education, or Treatment, Revised June 2011, Exhibit 5.44.
477
See H. Comm. on Energy and Commerce, Select Investigative Panel on Infant Lives, Hearing on Bioethics and
Human Tissue, Mar. 2, 2016. http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04Transcript-20160302.pdf
478
45 C.F.R. 46.116.

217

iii) HHS Regulations on IRBs

Novogenixs counsel represented that the [Founder and Executive Director] was fully
aware of the HHS IRB regulations.479 Before he started the firm, the [Founder and Executive
Director] had submitted proposals to an IRB.
Through that application process before the institutional review board, [Founder and
Executive Director] was required to review and comply with certain rules and regulations and
this developed an understanding of them. Such subjects included, but were not limited to the
following:

Anonymity [sic]
Informed Consent [sic]
Donation of fetal tissue for scientific research [sic]480

The Panel has no evidence that Novogenix followed the HHS regulations on IRBs,
despite [Founder and Executive Director]s knowledge and understanding of the regulations.
iv) California Revenue and Tax Code
The Panel has uncovered evidence that shows Novogenix also may have violated the
California Revenue and Tax Code. Novogenix sold its services to customers in California; it
should have collected tax on those transactions. The Panel reviewed every invoice and purchase
order that were provided by Novogenixs known California customers. Based on that review,
there were 17 purchases by the University of Southern California upon which Novogenix did not
charge the legally required sales tax.481 What makes the missing sales tax more striking is that
Novogenix did charge the required sales tax to all other purchases by the University of Southern
California, as well as Stanford University, and the University of California, Los Angeles. A chart
of those purchases is below (the Bates Stamp number column refers to the documents, as
provided by the university).

479

See Letter from Joshua A. Levy, Cunningham Levy LLP, to Charles Ingeberston, Chief Counsel, Committee on
Energy and Commerce, Sept. 2, 2015, at 3.
480
Id. at 2.
481
Purchase orders produced by the Keck School of Medicine at the University of Southern California to the Panel
Exhibit 5.46.

218

DATE OF
PURCHASE
ORDER

AMOUNT

SALES TAX

BATES STAMP
NUMBER

3/12/2013

$ 1,700.00

KSM0001002

4/11/2013

$ 1,700.00

KSM0000978

5/20/2013

$ 2,450.00

KSM0000973

5/20/2013

$ 2,100.00

KSM0000968

8/30/2013

700.00

KSM0000944

2/18/2014

200.00

KSM0000888

5/14/2014

$ 1,000.00

KSM0000834

7/24/2014

431.20

KSM0000781

7/24/2014

629.60

KSM0000777

7/29/2014

$ 1,000.00

KSM0000768

8/20/2014

630.40

KSM0001090

8/21/2014

350.00

KSM0001086

9/29/2014

431.20

KSM0001058

9/29/2014

231.20

KSM0001054

10/9/2014

231.20

KSM0001050

10/9/2014

431.20

KSM0001046

10/27/2014

$ 1,000.00

KSM0001032

11/6/2014

$ 2,100.00

KSM0001028

11/13/2014

KSM0001023

229.60

219

18. Conclusions
The Panel referred Novogenix potential violations of 42 U.S.C. 289g-2 to the U.S.
Department of Justice. It referred Novogenixs possible violations of the California Health and
Safety Law and the California Tax Revenue and Tax Code to the Los Angeles County District
Attorney. Finally, the Panel referred Novogenix potential violations of federal regulations on
consent to the U.S. Department of Health and Human Services.
D. Advanced Bioscience Resources, Inc.
1. Summary
The Panel conducted an investigation of Advanced Bioscience Resources, Inc. (ABR)
and uncovered evidence that ABR may have violated 42 U.S.C. 289g-2 and the California
Health and Safety Law.
a) Background of ABR
ABR, a non-profit corporate foundation, was started in 1989 as a resource for
biomedical, scientific, and educational purposes.482 It specializes in the procurement,
preservation and distribution of both human fetal tissues and full term umbilical cord blood for
research.483 ABR obtains fetal tissue from abortion clinics and offers it to researchers for a
fee.484 ABR generally pays abortion clinics a flat per-tissue fee regardless of the type or amount
of tissue procured. The tissue is obtained by tissue technicians embedded by ABR in abortion
clinics. The technicians harvest, package, and ship the tissue to the researchers. The abortion
clinic staff obtains consent from the patients for fetal tissue donations. ABRs business model is
that of StemExpress. Notably the CEO of StemExpress began her career in the fetal tissue
industry as a tissue technician at ABR.
b) History of the Panels Interactions with ABR
On September 3, 2015, ABR responded to a document request by the House Energy and
Commerce Committee.485 When H. Res. 461 created the Panel on October 7, 2015, Energy and
Commerce gave the Panel the production from ABR. Seeing the need for additional information,
the Panel sent ABR a document request on January 21, 2016.486 When ABR did not fully
produce, the Panel issued a subpoena to ABR on April 29, 2016.487
The Panel and ABRs counsel came to a verbal agreement that ABR could respond to the
subpoena on a rolling production basis. To date, ABR has still not fully complied with the
482

Advanced Bioscience Resources, Inc., Production to the Subcommittee on Oversight and Investigations of the US
House of Representatives Energy and Commerce Committee, Sept. 3, 2015 (HCEC000004), Exhibit 5.47.
483
Id.
484
Id.
485
Id., (HCEC000001), Exhibit 5.47.
486
Document Request to Advanced Bioscience Resources, Inc. (Jan. 21, 2016), Exhibit 5.48.
487
Subpoena to Advanced Bioscience Resources, Inc. (Apr. 29, 2016), Exhibit 5.49.

220

subpoena. It has not produced bank records or internal communications and has fully redacted
names from the documents it has produced.
2. ABRs Business Model
ABR obtains fetal tissue from abortion clinics and offers it for resale to researchers. It
pays the clinics a flat fee for services on a product of conception (POC) basis, regardless of how
many, or what type, of specimens are procured . . . .488 The fees range from $45 to $60,
depending upon the year and the clinic.489 The tissue is obtained by ABR tissue technicians who
are embedded in the abortion clinics; the technicians harvest, package, and ship the tissue to the
researchers.490 The abortion clinic staff obtains consent from the patients for fetal tissue
donations.491
ABR represented that it does not have a website through which researchers request tissue.
It is unclear whether that is accurate. Researchers apply for tissue through email. Applications
are reviewed by senior ABR officials, including the president. The review is focused on the
scientific creditability and feasibility of their studies. Once approved, researchers send their
specific tissue requests via facsimile, email, or phone call.
In order to harvest the tissue, ABR embedded tissue technicians within the abortion
clinics. ABR has not yet produced sufficient documents for the Panel to determine how
customers tissue orders are communicated to the embedded technicians. The technicians typical
workday went as follows:

The technicians contacted the clinics about the surgery schedule.

They confirmed that the clinics had obtained consent from women undergoing abortions,
either by speaking with clinic staff or by reviewing medical records. The clinics used an
ABR consent form, similar to that used by StemExpress. The form states: Recent
advancements in medical research have been developed through the use of human tissues
. . . Diseases such as diabetes, hemophilia, Parkinsons disease, cancer, AIDS, heart and
lung diseases . . . are being investigated for the development of cures through the use of
human fetal tissues.

After the abortions were performed, the technicians identified and procured tissue per
researchers requests, placed the tissue in preservatives, packaged it, put it in shipping
boxes, and delivered it to a courier or courier company.

The technicians updated ABR on the tissue requests as they were fulfilled.

Advanced Bioscience Resources, Inc., ABR Overview: Key Points, at 5 (SP000752), Exhibit 5.50.
Advanced Bioscience Resources, Inc., Production to the Subcommittee on Oversight and Investigations
(HCEC000028 41), Exhibit 5.51.
490
Advanced Bioscience Resources, at 7 (SP000754), Exhibit 5.50.
491
Id. at 5.
488
489

221

In contrast to the StemExpress case study, ABR employees are paid a salary or hourly
wage and do not receive any bonus or other incentive payments based on the number or
type of tissues they collect.492

3. ABR Payments to Abortion Clinics

According to productions made by 25 clinics from which ABR has received fetal tissue,
ABR paid them a total of $1,002,147 from 2010 to 2015. ABR has only produced the payments
it made in 2015, during which ABR made nearly $80,000 in payments to its top five abortion
clinic sources from which it procured human fetal tissue. ABR paid the clinics costs for clinical
staff obtaining consents, maintaining records, transferring fetal tissue, clinical space, and
utilities.493 The chart below shows ABR facility fee payments from 2010 through 2015 to the
abortion clinics from which it obtained fetal tissue:

492

Advanced Bioscience Resources, Inc., Production to the Subcommittee on Oversight and Investigations
(HCEC000045), Exhibit 5.52.
493
ABR Overview: Key Points at 5 (SP000752), Exhibit 5.50

222

CLINIC

TOTAL

Atlanta Womens Center

$ 1,972

Cherry Hill Womens Ccenter

$ 22,424

Choice Medical Group

$397,966

Downtown Womens Center, Inc

$ 4,550

Family Planning Specialist

$ 36,585

Feminist Womens Health Center

Lovejoy Surgical Center

$ 135,565

M. Hanson

$ 28,970

Meadowbrook Womens Center

$ 13,585

Philadelphia Womens Center

$ 10,860

Planned Parenthood Riverside

$ 163,140

Planned Parenthood First Avenue

$ 145,315

Planned Parenthood Mar Monte (Sacramento)

5,390

Planned Parenthood San Diego

5,500

Pregnancy Consultation Center

$ 10,395

Whole Womens Health

300

6,600

4. ABR Revenue from Customers

ABRs payments to the clinics should be contrasted with the amounts ABR has received
from its customers. ABR produced payments from only a limited number of researchers to whom
it transferred fetal tissue, covering invoices for a single year. Its production of invoices presents
an incomplete picture of its income. ABRs income tax forms report $6.5 million in total revenue
for the last five reporting years (2010-2014).
Pursuant to document request letters, researchers produced payments to ABR. According
to these documents produced by the customers, ABR received $1,425,769.08 from the years
2010-2015. According to ABRs production, customers paid the non-profit $1,148,538.08 from
223

2010-2015. Therefore, according to the incomplete information the Panel has received, ABR
received $423,622.08 more from customers than it paid to the clinics for the fetal tissue. Due to
ABRs incomplete production, it is difficult to draw a complete conclusion based on these
numbers. The chart below shows the amount of money ABR received from its customers:
Comparison of fetal tissue sales invoices obtained from ABR and directly from ABR's customers
Names of Customers

All Cells LLC

Celula, Inc.
Childrens Hospital of Philadelphia
City of Hope
CO State University
Columbia University
Dartmouth
FDA/CDER
Johns Hopkins Medicine
Lonza Walkersville
Mass General Hospital
National Institute of Health
Rockefeller University
Samsung Biomed Res Inst
Sciencell Research Labs
Stanford University
SUNY Health Sciences Center
Temple University
University of CA SF
University of CA-LA School of Medicine
University of CT Health Center
University of MA Medical School
University of NC at Chapel Hill
University of PA Medical Center
Vertex Pharmaceuticals
Yale University Medical School

Produced by Customer

Produced by ABR
2010-2015
27,405.08
85,755.00
9,650.00
12,830.00
20,100.00
27,940.00
8,780.00
24,890.00
23,835.00
215,454.00
92,320.00
32,330.00
31,810.00
21,840.00
22,600.00
25,290.00
51,420.00
1,280.00
122,169.00
155,120.00
50,460.00
40,870.00
44,390.00
1,148,538.08

2016
-

Total
27,405.08
85,755.00
9,650.00
12,830.00
20,100.00
27,940.00
8,780.00
24,890.00
23,835.00
215,454.00
92,320.00
32,330.00
31,810.00
21,840.00
22,600.00
25,290.00
51,420.00
1,280.00
122,169.00
155,120.00
50,460.00
40,870.00
44,390.00
1,148,538.08

2010-2015
27,405.08
9,650.00
12,830.00
185,430.00
8,780.00
1,020.00
209,109.00
143,685.00
7,860.00
24,865.00
26,140.00
62,615.00
1,280.00
231,970.00
286,280.00
132,295.00
1,371,214.08

2016

1,220.00
1,835.00

51,500.00

54,555.00

Total
27,405.08
9,650.00
12,830.00
185,430.00
8,780.00
1,020.00
209,109.00
143,685.00
9,080.00
24,865.00
27,975.00
62,615.00
1,280.00
283,470.00
286,280.00
132,295.00
1,425,769.08

Variance
Based on 2010-2015
Totals
85,755.00
20,100.00
(157,490.00)
24,890.00
(1,020.00)
23,835.00
6,345.00
92,320.00
(111,355.00)
31,810.00
21,840.00
(7,860.00)
(2,265.00)
(26,140.00)
25,290.00
(11,195.00)
(109,801.00)
(131,160.00)
(81,835.00)
40,870.00
44,390.00

ABR transferred both human fetal tissue and body parts to researchers. Among those
body parts were brains, hearts, eyes, skulls, eyes, spinal cords, spinal columns, and skin.

224

ABR 2015 Fetal Sales to Top 5 Customers Product and Totals

80 Fetal Brains totaling .................................................................................................................. $26,160
51 past 20 weeks gestation

36 Pairs of Eyes totaling ................................................................................................................. $25,160

15 past 20 weeks gestation

8 Hearts totaling ................................................................................................................................ $2,720

6 past 20 weeks gestation

16 Spinal Cords totaling ................................................................................................................... $5,100

7 past 20 weeks gestation

2 Intact Calvarium totaling .............................................................................................................. $1,100

1 past 20 weeks gestation

2 Spinal Columns totaling ................................................................................................................... $680

1 past 20 weeks gestation

2 Skins totaling ..................................................................................................................................... $680

Both past 20 weeks gestation

Summary Total for Top 5 Customers...$61,600

5. ABR May Have Violated Federal and State Laws and Regulations
The Panel compared materials provided by ABR to 289g-2, which prohibits receipt of
valuable consideration for fetal tissue. Valuable consideration excludes costs associated with
the transportation, implantation, processing, preservation, quality control, or storage of human
fetal tissue.494 Materials produced to the Panel by ABR created an unclear picture of their
conduct and income. For example, ABR stated that it pays clinics costs for clinical staff
obtaining consents, maintaining records, transferring fetal tissue, clinical space, and utilities.495
Only the costs of transfer of fetal tissue can offset valuable consideration. The same ABR
document states that its tissue technicians procure the tissue, package it, and ship it.496 When the
Panel asked ABR whether it prepares tissue for research, or modifies it into cell lines, the firms
attorney stated ABR does not provide any other services other than simple tissue procurement. .
. .497

494

42 U.S.C. 289g-2(e)(3).
Advanced Bioscience Resources, Inc., ABR Overview: Key Points, at 5 (SP000752), Exhibit 5.50.
496
Id. at 7.
497
Letter from Jonathan F. Lopez, Orrick, Herrington & Sutcliffe, to Rep. Blackburn, Chairman, Select Investigative
Panel 2 (Feb. 24, 2016), Exhibit 5.53.
495

225

Due to ABRs failure to produce a complete response to the Panels subpoena and based
on a thorough assessment of the information received, the Panel saw the need for a criminal
investigation into ABRs fetal tissue practices. Therefore, the Panel sent criminal referrals to
U.S. Attorney General Loretta Lynch and the District Attorney of Riverside County, California,
urging them to conduct an investigation into whether ABR violated federal and state statutes and
regulations, and to take appropriate action if the investigation reveals criminal behavior.
E. Human Fetal Tissue Repository
6. Summary
The Panel sought to determine whether the Human Fetal Tissue Repository (HFTR) fully
complied with the applicable federal law and regulations. HFTR only produced a partial list of
the entities from which it received and to which it distributed fetal tissue to the Panel. HFTR did
not produce detailed accounting or cost documents to the Panel. As a result, the Panel had
insufficient evidence to determine whether HFTR complied with the applicable federal law.
a) Background of the Human Fetal Tissue Repository
HFTR operated within the Albert Einstein College of Medicine (Einstein) of Yeshiva
University, located in The Bronx, New York.498 HFTR began operations in March 1993.499
Einsteins executive dean provided two different closure dates: He first told the Panel that HFTR
closed on March 2, 2015.500 The dean later told the Panel HFTR closed in September 2015.501
The dean stated that in September 2015, Einsteins operations were spun out from Yeshiva
University to under [the] operational control of Montefiore Health Systems.502
The Panel sought to determine the disposition of the fetal tissue held by HFTR after its
closure. The Panel had insufficient evidence to make that determination. However, there are
indications that Einstein offered the tissue to the Planned Parenthood Federation of America
(PPFA). [PP Witness #3] stated that after HFTR closed, The people from Einstein came to visit
us to see if [PPFA] would take over their repository.503 The PPFA official added that Planned
Parenthood abandoned the proposal because It seemed like a lot of effort . . . .504

498

Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] 1 (Feb. 10, 2016).
499
Email from [Einstein Executive Dean], Albert Einstein College of Medicine, to Panel staff. (Nov. 27, 2016).
500
Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] 1 (Feb. 10, 2016).
501
Id. at 2.
502
Id. at 1.
503
Center for Medical Progress video FNND0569_ 20150226165708. The video was produced to the H. Comm. on
Oversight and Government Reform pursuant to a subpoena. Panel staff viewed it under the terms of an agreement
between the Chairman and Ranking Member of the H. Comm. on Oversight and Government Reform.
504
Id.

226

HFTR received fetal tissue from three New York City hospitals, and it distributed the
tissue to Einstein researchers and to fourteen other educational and research institutions.505
HFTR received reasonable payments associated with necessary activities such as transportation,
processing, preservation, or quality control of the tissue from the research institutions to which
it provided fetal tissue.506 The payments were $100 per sample for Einstein researchers and $250
per sample for outside researchers.507 Documents produced by a research institution that received
fetal tissue from HFTR show payments to HFTR of $250 per fetal tissue specimen.508
b) History of the Panels Interactions with HFTR
On December 18, 2015, the Panel sent HFTR a document request letter asking for,
among other items, a list of all entities from which it procured fetal tissue, a list of all entities to
which it sold or donated fetal tissue, an organization chart, all communications that direct its
employees to procure fetal tissue, all accounting records, and banking records related to the
procurement, sale, donation, and distribution or shipment of fetal tissue.509
Einsteins response was delayed until after the production deadline of December 31,
2015, because after the closure of HFTR, the person to whom the letter was addressed was no
longer employed by Einstein.510 The Panel granted Einstein a production extension until January
31, 2016.511 In the course of its review of HFTR records, Einstein discovered that it was missing
all records for the period of January 2010 through July 2010.512
Einstein produced a list of entities from which it obtained and distributed fetal tissue to
the Panel.513 Einstein represented that it could not locate accounting records.514 To date, the
Panel has not received any communications that relate to fetal tissue or any accounting or
banking records.

505

Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] 1-2 (Feb. 10, 2016).
506
See id. at 1.
507
See id. at 2.
508
Invoices produced by the University of Connecticut Health Center to the Panel [000005-000007], Exhibit 5.54.
509
See Letter from Rep. Marsha Blackburn, Chairman, House Select Investigative Panel, to [HFTR Official] (Dec.
18, 2015).
510
Email from [Einstein Vice-President, Government and Community Relations], Albert Einstein College of
Medicine of Yeshiva University, to Panel staff (Jan. 12, 2016).
511
Telephone conference between [Einstein Vice-President, Government and Community Relations], Albert
Einstein College of Medicine of Yeshiva University, and Panel staff (Jan. 12, 2016).
512
Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] 2 (Feb. 10, 2016).
513
Documents produced by Albert Einstein College of Medicine of Yeshiva University to the Panel (Jan. 27, 2016)
[hereinafter Documents produced by Albert Einstein], Exhibit 5.55.
514
Telephone conference between [Einstein Vice-President, External Affairs], Albert Einstein College of Medicine
of Yeshiva University, and Panel staff (Jan. 27, 2016).

227

7. Hospitals from which HFTR Procured Fetal Tissue

HFTR did not procure fetal tissue directly from abortion clinics; rather, it received
tissue from Jacobi Medical Center, North Central Bronx Hospital, and Weiler Hospital.515
8. Procurement Process
The Panel sought to determine HFTRs procurement procedures, including whether it had
contracts with the hospitals from which it procured fetal tissue. Due to the lack of records
provided by Einstein, the Panel had insufficient evidence to determine whether HFTR had
contracts with those medical facilities; how much, if any anything, HFTR paid for the tissue;
whether the hospitals or HFTR obtained consent; how the consent was obtained; and the content
of the consent form.
The Panel sought to determine the number of women from which HFTR obtained fetal
tissue and the number of fetal tissue samples HFTR obtained. Documents produced by Einstein
to the Panel show that a total of 2,701 subjects were enrolled in HFTR studies.516 The Panel
had insufficient evidence to determine the number of fetal tissue samples HFTR obtained.
Documents produced by the University of Wisconsin School of Medicine and Public
Health (UW SMPH) to the Panel show that HFTR required detailed information from each of its
potential customers. HFTR sent each applicant a letter that listed the information it required. The
letter stated:
In order to expedite your request, please provide [HFTR] with [the]
following information:

An abstract and brief summary of your IRB-approved human

experimentation protocol. Clearly state which tissues you will use
for your study and why you must use human tissues and human
fetal tissues in particular.
A copy of your local IRB approval letter. When filing out your IRB
application, be sure to state that you will be receiving tissue from
[HFTR].
Please read and sign the enclosed Risk Handling Statement.
Please read and sign the Non-Transplant Fetal Tissue Request Form.
. . . These agreements emphasize several issues:

1. You are responsible for understanding and adhering to appropriate

safety standards for the protection of yourself and laboratory
personnel under your supervision who will be handling the human
tissue.
515

Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] (Feb. 10, 2016).
516
Documents produced by Albert Einstein, Exhibit 5.55.

228

2. Unless you are licensed to do so by New York State, you may not
distribute any portion of the tissue disbursement or products derived
therefrom to colleagues or other investigators.517
The Non-Transplant Fetal Tissue Request Form stated that researchers who received fetal
tissue from HFTR agreed to use the specimens in compliance with all applicable standards and
regulations, including, but not limited to those relating to research involving human and animal
subjects . . .518 The form further stated that researchers will pay a transmittal fee of $250 per
sample to reimburse [HFTR] for its preparation and distribution costs.519
In addition to the non-transplant fetal tissue request form, HFTR required researchers to
sign a Material Transfer Agreement, which stated in part that the fetal tissue IS NOT FOR USE
IN HUMAN SUBJECTS, and will be used for teaching or for not-for-profit research purposes
only.520
9. Researchers that Received Fetal Tissue from HFTR
The incomplete documents produced by Einstein to the Panel show that HFTR distributed
fetal tissue to fourteen research institutions. The Panel had insufficient evidence to determine
whether the list below, which was compiled from Einsteins incomplete production,
encompasses the entire universe of research institutions that received fetal tissue from HFTR:

Montreal Neurological Institute

University of California, Irvine

New York University School of Medicine

Memorial Sloan-Kettering Cancer Center

Yale University School of Medicine

Wayne State University School of Medicine

Rockefeller University

517

Albert Einstein College of Medicine of Yeshiva University, Human Fetal Tissue Repository (Dec. 15, 2010),
produced by the University of Wisconsin-Madison School of Medicine and Public Health to the Panel (emphasis in
original) [0171], Exhibit 5.56.
518
Documents produced by Albert Einstein, Exhibit 5.55.
519
Id.
520
Albert Einstein College of Medicine of Yeshiva University, Material Transfer Agreement for Transfer of Material
to Academic, Non-Profit Organizations (Sept. 3, 2009), produced by the University of Wisconsin-Madison School
of Medicine and Public Health to the Panel [0172] (emphasis in original), Exhibit 5.57.

229

University of Connecticut Health Center

University of Virginia

Johns Hopkins

State University of New York, Buffalo

University of Wisconsin

University of Medicine and Dentistry of New Jersey

Childrens National Medical Center521

The Panel sought to determine the number of fetal tissue samples each research
institution received and the amount of money that HFTR received from those institutions. Due to
Einsteins lack of production, the Panel lacked sufficient evidence to make such a determination.
10. Conclusions
HFTR produced a limited set of documents to the Panel. Among the types of documents
that HFTR did not produce were accounting records. Thus, the Panel has insufficient evidence to
determine the cost to HFTR for the transportation, processing, preservation, quality control, or
storage of fetal tissue. The Panel has insufficient evidence to determine the total amount that
HFTR received from the research institutions that obtained tissue from the repository.
Documents produced by HFTR to the Panel show that it required researchers to submit
summaries of their IRB-approved protocols, and copies of their IRB approval letters. Those
documents show HFTR also required researchers to state what tissues they will use for their
study, why they must use human tissue generally, and fetal tissue in particular. The documents
produced by HFTR to the Panel show the repository required researchers who applied to receive
fetal tissue to use the samples in compliance with all applicable laws and regulations, including
the HHS regulations on research that involves human subjects.
Based solely on HFTRs limited productions, The Panel determined it appears that HFTR
complied with the applicable HHS regulations, or at least made an attempt to do so. The Panel
has insufficient evidence to make a conclusive determination whether HFTR and the research
institutions to which it supplied fetal tissue fully complied with the HHS regulations.

521

Letter from [Einstein Executive Dean], Albert Einstein College of Medicine, to Rep. Marsha Blackburn,
Chairman, Select Panel on Fetal Lives [sic] 1 (Feb. 10, 2016). See generally documents produced by Albert Einstein
College of Medicine of Yeshiva University (Jan. 27, 2016).

230

VII. Case Studies of the Fetal Tissue IndustryThe

University/Clinic Model
Chapter VI Redaction Key:
1. [Clinic A Dr. #1] is an employee of Southwestern Womens Options and a faculty
member of the University of New Mexico.
2. [Dr. Administrator] is a faculty member of the University of New Mexico.
3. [NM Doctor #2] is a faculty member of the University of New Mexico.
4. NM Doctor #3] is a director of Southwestern Womens Options and a faculty member of
the University of New Mexico.
5. [NM Doctor #4] is a faculty member of the University of New Mexico.
6. [NM Doctor #5] is an employee of Southwestern Womens Options and a faculty
member of the University of New Mexico.
7. [NM Doctor #6] is an employee of Southwestern Womens Options.
8. [Dr. Administrator #2] is a faculty member of the University of New Mexico.
9. [NM Research Doctor] is a faculty member of the University of New Mexico.
10. [NM Patient] was a patient at Southwestern Womens Options.
11. [WA Clinic Director] Executive Director and co-founder of the Cedar River Clinics.
12. [WA Doctor #1] is a faculty member at the University of Washington and also works at
the Cedar River Clinics.
13. [WA Doctor #2] is a physician who works at the Cedar River Clinics.
14. [WA Doctor #3] is a faculty member at the University of Washington and also works at
the Cedar River Clinics.
15. [WA Doctor #4] is a faculty member at the University of Washington and also works at
the Cedar River Clinics.
16. [WA Doctor #5] previously worked at the Cedar River Clinics while a faculty member at
the University of Washington.

231

17. [WA Doctor #6] is a former University of Washington resident who worked at the Cedar
River Clinics and currently works at the Swedish Medical Center.
18. [WA Doctor #7] is a former University of Washington resident who worked at the Cedar
River Clinics and currently works at Northwest Womens Healthcare.
19. [WA Doctor #8] is a faculty member at both the University of Washington and
Northwestern University and owner and operator of All Womens Health-North.
20. [WA Doctor #9] is a physician who formerly worked at the Cedar River Clinics and now
works at All Womens Health-North.
21. [WA Patient] was a patient at the Cedar River Clinics who filed a medical malpractice
suit against [WA Doctor #2] for injuries alleged following an abortion performed at 25+
weeks.
22. [WA Doctor #10] is a former resident and current faculty member at the University of
Washington who served as medical director of the Planned Parenthood of Greater
Washington and North Idaho.
23. [WA Doctor #11] is a faculty member at the University of Washington and also works at
the Planned Parenthood of Greater Washington and North Idaho.
24. [WA Research Doctor #1] is a faculty member at the University of Washington and the
author of the universitys Birth Defects Research Laboratorys NIH grant proposals.
25. [WA Research Doctor #2] is a research scientist at the University of Washington who has
participated in fetal tissue research studies.
26. [WA Research Doctor #3] is a former resident at the University of Washington who has
participated in fetal tissue research studies.
27. [WA Research Staff] is a technical operations manager at the University of Washington
School of Medicines WWAMI Institution for Simulation in Healthcare. He has
participated in fetal tissue research studies.
28. [WA Administrator] is an administrator in the University of Washingtons government
relations office.
29. [PP Witness #1] is an abortion provider in Los Angeles, California, an executive with
Planned Parenthood Federation of America (PPFA) who is in charge of the PPFA Manual
of Medical Standard and Guidelines.
30. [PP Witness # 2] is a manager of research projects at Planned Parenthood Gulf Coast
(PPGC).
232

31. [PPFA Lawyer] is a legal official at PPFA.

32. [PPFA Medical Officer #1] is a PPFA official who was responsible for medical issues.
33. [PPFA Medical Officer #2] is a PPFA official who was responsible for medical issues.
34. [PPGC Abortion Services Official] is a manager of abortion services at PPGC.
35. [PPGC Abortion Doctor] is a doctor who performed abortions at PPGC.
36. [PPGC Staff] is a PPGC staff worker who assisted in the abortion clinic.
37. [UTMB Researcher # 1] is a researcher at the University of Texas Medical Branch who
worked with PPGC on fetal tissue procurement.
38. [PPGC Executive] is the director of abortion services and medical director at PPGC.
39. [UTMB Researcher #2] is a second researcher at the University of Texas Medical Branch
who worked with PPGC on fetal tissue procurement.
40. [UTMB Staff] is a UTMB staff worker who administers contracts for researchers.
41. [BCM Researcher] is a researcher at the Baylor College of Medicine who worked with
PPGC on fetal tissue procurement.
42. [BCM Staff] is a staff employee at the Baylor College of Medicine who worked with
PPGC on fetal tissue procurement.
43. [BCM Contract Manager] is an employee of the Baylor College of Medicine who
manages contracts.
44. [MO Doctor #1] is a faculty member of the Ob/Gyn department of the Washington
University School of Medicine and also works at Planned Parenthood of the St. Louis
Region and Southwest Missouri.
45. [MO Doctor #2] is Planned Parenthood of the St. Louis Region and Southwest Missouris
pathologist and the owner of Pathology Services, Inc.
46. [MO Doctor #3] is a faculty member of the Ob/Gyn department of the Washington
University School of Medicine and also works at Planned Parenthood of the St. Louis
Region and Southwest Missouri.

233

47. [MO Doctor #4] is a faculty member of the Ob/Gyn department of the Washington
University School of Medicine and also works at Planned Parenthood of the St. Louis
Region and Southwest Missouri.
48. [MO Doctor #5] is a faculty member of the Ob/Gyn department of the Washington
University School of Medicine and also works at Planned Parenthood of the St. Louis
Region and Southwest Missouri.
49. [MO Doctor #6] is or was a clinical fellow in the Ob/Gyn department of the Washington
University School of Medicine and also works at Planned Parenthood of the St. Louis
Region and Southwest Missouri.
50. [WI Doctor #1] was an assistant professor of Ob/Gyn at the University of Wisconsin,
School of Medicine and Public Health, while serving as the associate medical director of
Planned Parenthood of Wisconsin.
51. [WI Doctor #2] is the director of the Ryan Fellowship and a member of the Ob/Gyn
faculty at the University of Wisconsin, School of Medicine and Public Health, and also
works at Planned Parenthood of Wisconsin.
52. [MI Doctor] is both an associate professor in University of Michigans Ob/Gyn
department and medical director for Planned Parenthood in Ann Arbor.

A. Summary
The Panel identified several research institutions across the United States, most of them
state universities and virtually all of them recipients of federal as well as state funding, that have
formed a close relationship with one or more abortion clinics. They regularly acquire tissue from
those clinics for research purposes and in some cases distribute fetal tissue to other research
institutions. Typically, the research institution requests specific human fetal organs or tissue, of a
specific gestational age, from an abortion clinic, and the clinic informs the research institution
when they have abortions scheduled that may produce the desired human body parts. Over time,
the clinic learns which human fetal organs and tissue are useful to the research institution and
often alerts the research institution to their availability without prior solicitation. Once available,
the research entities make arrangements to transfer the fetal organs and tissue from the clinic. In
some cases, the research institutions also have relationships with tissue procurement companies.
In still other cases, partnerships do not involve the transfer of fetal tissue between the clinics and
universities, but they share medical school faculty and residents in common, raising additional
issues about the role of government-funded institutions in providing abortions and driving the
demand for fetal tissue. The Panel sought to understand these and other factors relevant to its
analysis of fetal tissue transactions under 42 U.S.C. 289g-2 and to determine what role, if any,
government funding plays in the transactions between abortion clinics and universities.
234

B. The University of New Mexico, Southwestern Womens Options, and Planned

Parenthood
8. Summary
The Panels investigation examined the relationship between the University of New
Mexico and a late-term abortion clinic near the university. A tissue technician employed by the
University of New Mexico (UNM) traveled frequently to Southwestern Womens Options
(SWWO), a clinic located one mile from UNM that performs abortions through the third
trimester, to procure human fetal organs or tissue an average of 39 times a year since 2010.
Additionally, several UNM medical faculty were scheduled on a weekly basis to perform
abortions at a local Planned Parenthood affiliate.
The Panel submitted document requests to UNM and SWWO on January 6, 2016.
Following both entities refusal to make a complete production,522 the Panel issued subpoenas
dated February 12, 2016. The Panel conducted depositions of [Clinic A Dr. #1] of SWWO on
May 6, 2016, and of [Dr. Administrator] of UNM on May 11, 2016. The Panel sought to
understand whether the safeguards anticipated by 289g-2 were in place, including whether too
close a relationship might be formed between an abortion clinic and researchers. In the course of
its inquiry, the Panel uncovered a lattice work of close connections between UNM and SWWO.
SWWO is the sole provider of fetal tissue to UNM, and according to [Dr. Administrator], no
fetal tissue resulting from abortions performed at UNM are donated for fetal tissue research.523
The transfer of fetal tissue from SWWO to UNM was only one part of a much larger
regime of activities whereby UNM aggressively expanded abortion advocacy and services in
New Mexico. In a concerted and organized effort, the offices, personnel, and resources of UNM
and, in particular, leadership personnel at UNM medical school: (1) expanded UNMs role both
in providing abortions and in training new abortion doctors; (2) expanded UNMs referral for
abortion services to outside clinics, including the clinic from which it obtained fetal tissue; (3)
supplied residents and fellows to perform abortions for SWWO during the period that UNM was
obtaining fetal tissue from that clinic; (4) expanded the faculty of UNM by providing volunteer
faculty status to local abortion practitioners; (5) provided staff physicians for the Planned
Parenthood in Albuquerque from UNM faculty after that clinic transitioned from one owner to
another; and (6) leveraged their status to organize UNM employees and students for partisan
political activities.
UNM has stated that the fetal tissue transferred from SWWO is of great value to its
research department. But this close relationship led to shoddy clinical practices. For example,
while a UNM consent form for fetal tissue donation does exist, testimony obtained by deposition
and affidavit revealed that the form is not regularly used and that SWWO improperly combines
consent for tissue donation with consent for the underlying abortion procedure. In a second

522
523

See Chapter XI infra.

Transcript of Deposition of [Dr. Administrator], May 11, 2016 ([Dr. Administrator] Tr.), at 44, 187.

235

example, neither UNM nor SWWO appears to have any apparatus or procedure to aid those
infants who survive the abortion procedure.524
Documentation obtained by the Panel in the course of its investigation shows that the
transfer of fetal tissue from SWWO to UNM for research purposes is a systematic violation of
New Mexicos Jonathan Spradling Revised Uniform Anatomical Gift Act (Spradling Act). These
violations occurred as UNM personnel procured fetal tissue from patients at SWWO for research
by UNM entities. The Panel accordingly made a criminal referral to the Attorney General of
New Mexico recounting evidence of violations of law involved in the transfer and use of fetal
tissue between UNM and SWWO.
Based on a procurement log attached to that referral, a former patient at SWWO
discovered that her aborted infants remains were likely transferred to UNM for research.
Because UNM and SWWO had not given her the opportunity to give informed consent required
under 42 U.S.C. 289g-1, 45 C.F.R. 46, and New Mexicos Maternal, Fetal and Infant
Experimentation Act, the Panel followed with a second criminal referral to the Attorney General
of New Mexico.
9. The University of New Mexico Becomes an Abortion Provider
Before 2000, neither the UNM Hospital nor any of its clinics offered abortions except in
limited circumstances. Abortions were not performed except in rare cases of fetal anomaly or
certain threats to a pregnant womans healthand then only in the hospitals labor and delivery
or operating rooms. When abortions were performed, nursing personnel and anesthesiologists
often were unwilling to participate.525
UNMs practice changed dramatically following the efforts of an abortion policy
committeelargely spearheaded by [Dr. Administrator] and [NM Doctor #2], respectively,
faculty members of the universitys departments of Obstetrics and Gynecology (Ob/Gyn) and
Family Medicineto have UNM become a provider of abortions beyond the former limited
circumstances. The doctors objective met with opposition from upper-level UNM Hospital
administrators, who told them that UNM policy prohibited abortions at university clinics, that the
hospital would not subsidize abortion, and that nurses would not want to participate in any aspect
of abortion. Over the course of about a year and a half, the doctors pressed ahead with their
agenda, disregarding the admonitions of administrators and reservations of most of the hospital
staff who did not wish to be implicated in abortion practice. In 2002, the doctors succeeded in
introducing medical abortionthrough the use of mifepristone, or RU-486into UNM
clinics.526
The doctors then pressed further, against additional resistance by administrators, until
they successfully introduced surgical abortion into UNM clinics. To do this they overrode
524

See Chapter VII.E infra.

_______________, _________, You Cant Do That Round Here: A Case Study of the Introduction of Medical
Abortion Care at a University Medical Center, 71 Contraception 84, 84-85 (2005) [hereinafter You Cant Do That].
526
Id. at 84-88; [Dr. Administrator] Tr. at 140-41.
525

236

objections of clinic staff, despite acknowledging that such opposition may be intense,
particularly due to the more extensive patient interaction required for surgical procedures and the
increased complexity of the procedure. By that point, however, the doctors, whose salaries are
paid by the taxpayers of New Mexico, were disinclined to accommodate such moral qualms,
dismissively writing in a published article that while they anticipate hiring dedicated nurses and
support staff . . . . abortion opponents have limited rationale to prevent MVA [manual vacuum
aspiration] for pregnancy termination.527 Today, UNM Hospital performs surgical abortions for
any reason through 25 weeks gestation.528 At or beyond 24-25 weeks gestation, pregnancy
termination will be considered on a case-by-case basis for maternal or fetal reasons.529 [Dr.
Administrator] testified that [t]here are situations where third trimester terminations take place
at UNM Hospital, when there is a maternal indication or a fetal indication.530 Such an
indication could include a diagnosis of Down Syndrome.531 At the UNM Center for
Reproductive Health, surgical abortions are offered from the time when a pregnancy is first
identified through 23 weeks gestation, and medical abortions are offered up to 10 weeks
gestation.532 UNM also refers patients to SWWO and to clinics in Colorado and Maryland, the
Boulder Abortion Clinic and Germantown Reproductive Health Services, for late-term
abortions.533
The advocacy that introduced UNMs practice of medical and surgical abortion did not
occur as an initiative of activist faculty only. Grants from the Susan Thompson Buffett
Foundation provided funding to promote the expansion of abortion at UNM, including the
training of both faculty and students at UNM to become abortion providers.534 Such training
occurred through programs like the Center for Reproductive Health Education in Family
Medicine for Family Medicine residents and the Kenneth J. Ryan Residency Training Program
for Ob/Gyn residents.535

You Cant Do That at 88.

For examples of protocols regarding surgical and medical abortions offered at UNM during the first trimester, see
UNM Health Sciences Center, Medical Abortion [UNM01681], Exhibit 6.1; UNM Health Sciences Center,
Management of Very Early Pregnancy Medical and Surgical Abortion [UNM01689-UNM01691], Exhibit 6.2.
Abortions performed during the second trimester are either dilation and evacuation (D&E) or induction of labor.
UNMHSC, Second Trimester Pregnancy Termination, D&E and induction of labor, Exhibit 6.3.
529
UNMHSC, Second Trimester Pregnancy Termination, D&E and induction of labor [UNM01685], Exhibit 6.3.
530
[Dr. Administrator] Tr. at 46.
531
[Dr. Administrator] Tr. at 57.
532
UNM Center for Reproductive Health, Abortion Care, http://unmmg.org/clinics/crh/abortion-care/index.html,
Exhibit 6.4.
533
[Dr. Administrator] Tr. at 46-47.
534
The Susan Thompson Buffett Foundation 990-PF reports, Exhibit 6.5; [Dr. Administrator] Tr. at 128-29, 132-33.
While the Foundation was the source of funds for this fellowship, Berkshire Hathaway is by means of a sole
proprietorship the owner of Danco Laboratories, the sole distributor of mifepristone and the entity from which UNM
would obtain the medication when it undertook medical abortions. [Dr. Administrator] Tr. at 137-39.
535
You Cant Do That, at 85-86. These two programs and a thirdthe Access Project, which according to [Dr.
Administrator] is a part of the Center for Reproductive Health Education in Family Medicineentail three grants
for student programs that involve abortion. The Susan Thompson Buffett Foundation funds all three. [Dr.
Administrator] Tr. at 134-36.
527
528

237

10. UNM Provides Doctors to Southwestern Womens Options and Planned Parenthood
The doctors of UNMs Ob/Gyn department, with financial support from the Susan
Thompson Buffett Foundation, formed the UNM School of Medicine Fellowship in Family
Planning (UNM Fellowship), which served as the vehicle by which UNM medical residents were
deployed to the nearby Albuquerque abortion clinicsSWWO and Planned Parenthoodto
provide abortions. While, like any university fellowship, the UNM Fellowship had an
educational purpose, its major goal was to send UNM doctors to SWWO in order to give
additional volume of 2nd trimester abortions under the supervision of [NM Doctor #3] of
SWWO.536 [Dr. Administrator] initiated the training rotation with SWWO.537
The Panel obtained two UNM contracts with SWWO that provide for UNM residents to
supply staffing at the clinic. One contract is a single-page program letter of agreement
covering July 1, 2011, to June 30, 2012. It was not signed until January 2012, and the sole UNM
signatory was the program director of UNMs Family Medicine Residency Program.538 The other
contract totals two pages, covers the two-year period beginning July 1, 2014, and describes
assignments by which UNM fellows would perform abortion procedures at SWWO in two twoweek rotations.539 These rotations were entirely dedicated to training the fellows to competency
in the performance of the abortion procedure.540 The sole UNM signatory to this contract was the
director of the UNM Fellowship, [Dr. Administrator].
Neither the 2012 nor the 2014 contract was signed by an official with signature authority
under UNM policy, and neither contract indicates that it was reviewed by a contract review
officer in the University Counsels Office, another UNM policy requirement.541 The resident
rotation was a large-scale program at UNM, according to [Dr. Administrator]. All of the
interns rotate through, unless they opt out. So we do a very large scope of training.
Additionally, the physician assistant and nurse practitioner and nurse midwifery programs have
asked us to take nursing students, which we accommodate when we can.542
Under the New Mexico Tort Claims Act, UNM faculty, students, and residents had their
malpractice insurance provided by the state for their work at outside abortion clinics, including
536

UNM-SWWO agreement (June 2, 2014) [UNM03417-UNM03418] [hereinafter 2014 UNM-SWWO agreement],

Exhibit 6.6.
537
[Dr. Administrator] Tr. at 173-74.
538
UNM-SWWO agreement signed Jan. 5 and Jan. 7, 2012 [UNM03419], Exhibit 6.7.
539
2014 UNM-SWWO agreement. In her deposition, [Dr. Administrator] testified that fellows would train for
between two and six weeks. [Dr. Administrator] Tr. at 189.
540
[Dr. Administrator] Tr. at 189; Transcript of Deposition of [Clinic A Dr. #1], May 6, 2016 ([Clinic A Dr. #1]
Tr.), at 86-88.
541
See University of New Mexico Regents Policy Manual, Section 7.8: Signature Authority for Contracts, Exhibit
6.8; Administrative Policies and Procedures Manual, Section 5.2, Exhibit 6.9; University Business Policy 2010
Exhibit B2, Exhibit 6.10. When questioned about this deficiency in the UNM-SWWO contracts, [Dr. Administrator]
testified that what the university had with SWWO was in fact a program letter and not a contract. [Dr.
Administrator] Tr. at 147. She proceeded to admit that the program letter . . . defines the educational expectations
of the fellow . . . when they do this rotation and the expectations of the preceptor. Id. at 148. Such a document
setting forth mutual expectations would plainly seem to meet the legal definition of a contract.
542
[Dr. Administrator] Tr. at 87-88.

238

SWWO and Planned Parenthood.543 Neither SWWO nor Planned Parenthood provided fellows
any compensation.544 They received their entire compensation from UNM.545
[Clinic A Dr. #1], who participated in the fellowship while employed by UNM, testified
that she spent four weeksbroken into two two-week shiftsat SWWO and up to another 20
days at Planned Parenthood.546 During her fellowship, she was trained in the performance of the
abortion procedure by [Dr. Administrator] and by at least two SWWO doctors.547 In a given
week, which consisted of a full-time work schedule at the clinic, she estimated she might see 30
patients.548 After her fellowship ended, she joined the staff of SWWO, where she has worked full
time since 2014, alternating between SWWOs Albuquerque clinic and a second clinic it
operates in Dallas, Texas, where abortions are allegedly not performed beyond 21 weeks and six
days gestation.549 During the four weeks of her fellowship at SWWO in Albuquerque, she
testified she performed or assisted in approximately 10 to 15 third-trimester abortions.550
Including that number and factoring in her subsequent employment by the clinic, she estimated
she performed over the course of her work at SWWO in Albuquerque a total of possibly more
than 50 third-trimester abortions.551 Considering that [Clinic A Dr. #1]s employment at SWWO
has been based mostly in Dallas, which allegedly does not provide third-trimester abortions, and
that she spent only about a quarter of one year (2015) working at the Albuquerque location,552
her estimate suggests a particularly high volume of third-trimester abortions at SWWO in
Albuquerque.
Since the time when opposition to participating in abortion procedures was the
predominant view of UNM medical staff, the culture appears to have changed, along with the
composition of UNM hospital and clinic personnel, to one aggressively in favor of the expansion
of abortion. [Dr. Administrator], [NM Doctor #4], and other UNM medical faculty members
engage in political fundraising and lobbying for an expansion of abortion services and public
funding in support thereof. [Dr. Administrator] herself has held leadership positions the last five
years in the American College of Obstetricians and Gynecologists (ACOG) and the Society of
Family Planning.553 She testified that advocacy is . . . a core requirement in our training
program, one that falls under the ACGME accreditation requirements for Ob/Gyn residents.554
UNM students are encouraged to participate in such activities as ACOG Lobby Day, the New
Mexico Lobby Day, and the Congressional Leadership Conference, which are organized by
543

[Dr. Administrator] Tr. at 151-54; [Clinic A Dr. #1] Tr. at 152.

[Clinic A Dr. #1] Tr. at 92, 94-95, 97-98, 103.
545
[Clinic A Dr. #1] Tr. at 97-98, 102-103.
546
[Clinic A Dr. #1] Tr. at 86-88, 92-93. [Clinic A Dr. #1] recalled her compensation from UNM was in the low
fifties at the time of her fellowship. Id. at 102.
547
[Clinic A Dr. #1] Tr. at 89-91. [Clinic A Dr. #1] was already fully board certified at the time of her fellowship.
[Clinic A Dr. #1] Tr. at 102.
548
[Clinic A Dr. #1] Tr. at 147, 158-59.
549
[Clinic A Dr. #1] Tr. at 266.
550
[Clinic A Dr. #1] Tr. at 150, 247.
551
[Clinic A Dr. #1] Tr. at 247.
552
[Clinic A Dr. #1] Tr. at 266 (testifying that her employment at SWWO was exclusively in Dallas except for
alternating weeks between there and Albuquerque between January and approximately July of 2015).
553
[Dr. Administrator] Tr. at 126.
554
[Dr. Administrator] Tr. at 141.
544

239

ACOG.555 Meanwhile, the once-majority view among UNM medical personnel appears to have
been marginalized, if not punished outright. In January 2016, a medical student filed a lawsuit
against the UNM Board of Regents alleging that he was referred to a disciplinary committee by
[Dr. Administrator] and sanctioned by UNM for posting his personal views against abortion on
his Facebook page, despite the fact that the posts did not mention UNM.556
During the summer of 2015, amid the national news coverage of practices of abortion
clinics and tissue procurement companies with respect to the handling and possible sale of fetal
tissue, UNM fell under increased scrutiny. Members of the New Mexico state legislature began
to investigate UNMs relationship with SWWO and the handling of fetal tissue, as did a private
organization, the New Mexico Alliance for Life, and the Albuquerque Journal.557 In a terse letter
from [Dr. Administrator] to [NM Doctor #3] dated December 14, 2015, the UNM Fellowship
program at SWWO was terminated, despite the fact that more than six months remained under
the 2014 contract.558 [Dr. Administrator] testified the termination occurred after a review
conducted by the UNM Fellowship determined the fellows did not have the volume of second
trimester pregnancy terminations that were required for competency,559 but it is difficult to
dispute that the timing of UNMs decision was related to the various investigations.
UNMs contracts with Planned Parenthood are referred to as house officer affiliation
agreements and contain eight pages that provide details of the close working relationship
between the University and Planned Parenthood, largely in the form of providing resident UNM
physicians to staff the clinic.560 Over the course of its relationship with UNM, the Planned
Parenthood of New Mexico located in Albuquerque was acquired by Planned Parenthood of the
Rocky Mountains, after which UNM staffed the Albuquerque Planned Parenthood location not
only with fellows, but also with doctors from its Ob/Gyn department to serve as staff
physicians.561 Attached as an illustration of this relationship is a schedule generated by the
department for the month of May 2016 detailing rotations at the clinic for staff physicians from
UNM.562
11. UNM Confers Faculty Status and Benefits upon SWWO Personnel
Most of the doctors employed on the staff of SWWO also have what are described as
volunteer faculty positions at UNM. [NM Doctor #3] is a clinical assistant professor in the
Ob/Gyn department. [Clinic A Dr. #1] transitioned from employment at UNM to employment at
555

[Dr. Administrator] Tr. at 123. See also ACOG legislative activities update screenshot (May 2013), Exhibit 6.11
(noting an ACOG event attended by 60 Fellows, Junior Fellows, and medical students).
556
Complaint at 2, 6, 8-10, Hunt v. Board of Regents of the University of New Mexico, No. D-202-CV-2016-00143
(N.M. Dis. Ct., Bernalillo Co., Jan. 15, 2016).
557
Colleen Heild, UNMHSC Halts Training at Private Abortion Clinic, Albuquerque Journal, Dec. 20, 2015, at A1.
558
Letter from [Dr. Administrator] to [NM Doctor #3], (Dec. 14, 2015) [UNM03429], Exhibit 6.12.
559
[Dr. Administrator] Tr. at 149.
560
UNM-Planned Parenthood of New Mexico, Inc., House Officer Affiliation Agreement (June 13, 2012), at 1,
Exhibit 6.13; UNM-Planned Parenthood of the Rocky Mountains House Officer Affiliation Agreement (June 10,
2013), at 1, Exhibit 6.14.
561
See id.; [Clinic A Dr. #1] Tr. 93-94, 167-69.
562
See UNM staff rotations at Planned Parenthood, May 2016, Exhibit 6.15.

240

SWWO in 2014 and is a visiting instructor in the UNM Ob/Gyn department. [NM Doctor #5] is
a clinical assistant professor in the Family Community Medicine department while being
employed by SWWO.
Although as volunteers these SWWO physicians are not paid a salary by UNM, they do
receive substantial benefits for their faculty status. For example, they receive New Mexico Tort
Claims Act professional liability insurance coverage provided to university employees that is
extended to provide coverage for the duties and activities performed by the individual
Volunteer Faculty members, provided that such activities were assigned to them by the
department chairperson and that no other insurance covers such activities.563 They also appear to
have admitting privileges at the UNM Hospital.564
As volunteer faculty, these SWWO doctors also are entitled to a list of benefits at UNM
that include the following:
HEALTH SCIENCES CENTER LIBRARYAccess the HSC
Librarys online databases and extensive collection of over 600 fulltext online journals check-out privileges; and educational classes
NEW MEXICO EDUCATORS FEDERAL CREDIT UNION
membership
JOHNSON CENTERFacilities include the main and auxiliary
gyms, handball courts, weight room, tennis courts and Olympic-size
pool
ATHLETIC EVENTS50% discount on two season tickets for
football, and mens or womens basketball games
POPEJOY CULTURAL SERIESdiscounts on event tickets
MUSEUMSFree admission to the Fine Arts Museum, Maxwell
Museum of Anthropology, Geology Museums, Student Art Gallery,
and Museum of Southwestern Biology
LIBRARIESAccess to the Law Library on North Campus. The
libraries on main campus include: Zimmerman Library, Fine Arts
Center, Parish Library in the Graduate School of Management,
Tireman Learning Materials Library in the Educational Complex
and Centennial Science/Engineering Library

563

Volunteer Faculty Professional Liability Insurance Extension of New Mexico Tort Claims Act [UNM03399],
Exhibit 6.16.
564
See [Clinic A Dr. #1] Tr. at 99-100.

241

UNIVERSITY PRESSPublications may be purchased at a

discount at UNM bookstores
GOLFReduced rates on quarterly/annual memberships for the 9hole course. Discounts of the 18-hole Championship course may be
available.
RECREATIONAL EQUIPMENTNominal fees to rent tents,
camping gear, backpacks, snowshoes, cross-country skis, volleyball
sets, etc.565
From documents obtained by the Panel, there is also a question whether benefits such as access
to UNM library items are enjoyed by SWWO employees who are not known to be UNM faculty
members, whether because they were directly provided such access by UNM or because a
coworker at SWWO who is also a faculty member provided them such access from their
accounts.566
Apart from involvement in the UNM fellowship at SWWO, UNM volunteer faculty
members employed by SWWO are given no teaching or other academic obligations to UNM in
exchange for the benefits provided by UNM. In fact, to the question what duties did you have at
UNM as a volunteer faculty member? [Clinic A Dr. #1] answered, No specific duties come to
mind and added she was not . . . compelled to perform any teaching activities since becoming
volunteer faculty.567 Despite having admitting privileges, [Clinic A Dr. #1] has treated only one
patient at UNM Hospital since her employment began at SWWO, and that instance occurred
only because she happened to be speaking with candidates for the UNM Fellowship one day
when, due to a staff shortage, her services were needed in order for an abortion to proceed.568
UNM does, however, continue to receive on a regular basis one substantial benefit from SWWO:
fetal tissue.
12. UNM Performs Research Using Tissue from Infants Aborted at SWWO and Shares the
Tissue with Other Research Entities
Since 1995, SWWO has served as the only source of aborted infant tissue for research
purposes at the University of New Mexico Health Sciences Center (UNMHSC). UNMHSC
565

UNM School of Medicine, Volunteer Faculty Benefits [SWWO001234-SWWO001235], Exhibit 6.17. See also
[Clinic A Dr. #1] Tr. at 155, 259.
566
See, e.g., email correspondence of Feb. 16, 2016, in which [Clinic A Dr. #1], a UNM faculty member, provides
an article to [NM Doctor #6], an SWWO employee not known to be on the UNM faculty, after the latter noted,
Once again, Im having problems accessing the UNMHC [sic] library system. [SWWO001246], Exhibit 6.18.
567
[Clinic A Dr. #1] Tr. at 155-56. See also id. at 258 (I have no clinical or academic obligations necessarily
attached to that faculty status). When asked whether other SWWO doctors who doubled as UNM faculty members
ever taught courses at the University of New Mexico, [Clinic A Dr. #1] testified, I can recall being told of maybe
one. Id. at 158. When asked to identify any service she performed for UNM as a faculty member, she could think of
only one example, when she was asked once to participate in medical student oral examinations for their OB-GYN
rotation. [Clinic A Dr. #1] Tr. 260-61.
568
[Clinic A Dr. #1] Tr. at 101, 194-95.

242

asserts that [t]he tissue is donated at no cost to UNMHSC and it is picked up at the clinic by
UNMHSC staff.569 According to UNMs Human Research Review Committee, [w]omen
undergoing elective termination of pregnancy are consented by Southwest Womens Options
clinic, and can elect to have tissue used for research . . . . No interaction between women
undergoing the procedure and [UNM] laboratory personnel occurs.570
Laboratory notes produced to the Panel reveal that a UNMHSC employee has collected
aborted infant tissue from SWWO an average of 39 times a year since 2010.571 Organs harvested
include brain/head, heart, lung, eyes/retina, kidney, spleen, adrenal gland, intestines, bone
marrow, and stomach. At least some infants were administered digoxin. By July 2015, however,
digoxin was administered only to infants 20wks+.572
The notes contain information on aborted infants whose gestations ranged from
approximately 11.5 to 30.5 weeks, with many in the 14- to 18-week range. At least 20 aborted
infants were past 20 weeks gestation. The infants described include twins with clubbed feet
aborted at 16 weeks gestation, a 22.5-week aborted infant with Down Syndrome, 20-week
aborted twins with intact brains, a 25.3-week aborted female infant with an orofacial cleft, and a
30.5-week aborted intact infant.573 The remains of these and hundreds of other aborted infants
were collected from SWWO by UNMHSC staff and then taken to UNMHSC for use in research.
As recently as May 5, 2015, [NM Doctor #3] of SWWO wrote a letter to UNM detailing
his desire to continue to provide aborted infant tissue for research: This letter reconfirms my
ongoing assistance and support for your research involving human fetal tissue. I have reviewed
and been kept updated on your research and feel that the use of fetal tissue continues to be
appropriate for your studies. Therefore, I will continue to facilitate your collection of samples
from my clinic, following the usual inspection of the tissue.574 The Panel has no information to
suggest that SWWO has ceased providing aborted infant tissue to UNMHSC. The following
chart illustrates the operation of the university/clinic model through the UNM-SWWO
relationship:

569

UNM Second Submission to House Select Investigative Panel, at 1 (Feb. 16, 2016), Exhibit 6.19 [hereinafter
UNM Second Submission]; UNM Document [UNM00560], Exhibit 6.20; UNM First Submission to House Select
Investigative Panel, at 1 (Jan. 29, 2016), Exhibit 6.21; UNM Response to House Select Investigative Panel
Subpoena, at 1 (Mar. 3, 2016), Exhibit 6.22; SWWO letter responding to document request, at 1 (Feb. 12, 2016),
Appendix A, Exhibit 6.23.
570
UNM Study Document [UNM00790], Exhibit 6.24.
571
See Procurement notes [UNM00004-UNM00052] (Approximation: 201043 days; 201125 days; 201245 days;
201349 days; 201441 days; 201533 days), Exhibit 6.25.
572
Id. at [UNM00049], Exhibit 6.25.
573
Id. at [UNM00019, UNM00041, UNM00024, UNM00006], Exhibit 6.25.
574
Letter from [NM Doctor #3] to UNM [UNM01086] (May 5, 2015), Exhibit 6.26.

243

The tissue transferred from SWWO to UNM is of substantial value. According to UNM,
[s]ome of UNMHSCs most significant discoveries have arisen from its research involving fetal
tissue.575 The university stated that their collaboration with SWWO was integral to their
research: improved neonatal care and infant outcomes . . . . would not have occurred without the
translational research efforts of the DREAM [Developmental Research, Education, and
Mentoring Laboratory within UNMs Division of Neonatology] Lab in collaboration with
[redacted] and the providers at Southwest Womens Options.576
In a July 22, 2015, letter to New Mexico legislators, [Dr. Administrator #2] described
five studies using aborted infant tissue conducted or being conducted by a neonatologist in the
Department of Pediatrics.577 Additionally, [NM Research Doctor] of the DREAM Lab has
published at least eight studies which used tissue from aborted infants.578 Documents provided to
575

UNM Second Submission, at 2, Exhibit 6.19.

UNM Documents [UNM00560], Exhibit 6.20; UNM Documents [UNM00812 & UNM01105], Exhibit 6.27.
577
Letter from [Dr. Administrator #2] to New Mexico legislators 3-4 (July 22, 2015), Exhibit 6.28.
578
[NM Research Doctor] is an author or co-author of the following studies: (1) J Neonatal Perinatal Med. 2016
Mar. 12;9(1):91-7. doi: 10.3233/NPM-16915052. Epsilon globin gene expression in developing human fetal tissues;
(2) Pediatr Res. 2015 Apr.;77(4):500-5. doi: 10.1038/pr.2015.15. Epub 2015 Jan 14. VEGF mRNA and protein
concentrations in the developing human eye [hereinafter Human Eye Study]; (3) Circulation. 2014 May
27;129(21):2144-57. doi: 10.1161/CIRCULATIONAHA.114.009124. Epub 2014 Apr. 7. Existence, functional
impairment, and lung repair potential of endothelial colony-forming cells in oxygen-induced arrested alveolar
growth; (4) Gastroenterology. 2011 Jan.;140(1):242-53. doi: 10.1053/j.gastro.2010.09.043. Epub 2010 Sep 24. TGF2 suppresses macrophage cytokine production and mucosal inflammatory responses in the developing intestine; (5)
Am J Physiol Gastrointest Liver Physiol. 2009 Jul.;297(1):G1-G10. doi: 10.1152/ajpgi.90730.2008. Epub 2009 May
14. Epithelial cells in fetal intestine produce chemerin to recruit macrophages; (6) Pediatr Res. 2008
Apr.;63(4):394-7. doi: 10.1203/PDR.0b013e318165b8d1. Elevated erythropoietin mRNA and protein concentrations
in the developing human Eye; (7) Acta Paediatr Suppl. 2002;91(438):27-30. Erythropoietin and hypoxia inducible
576

244

the Panel list 18 studies conducted in collaboration with SWWO since 1995.579
The procurement notes provided to the Panel by UNM further confirm their acquisition
of aborted infant tissue from SWWO for research purposes. References to specific studies were
written in the notes along with lists of infant parts harvested. A lab technician wrote in May 2012
that someone from UNMHSC asked clinic for digoxin treated tissue 24-28 wks. for methylation
study + because [redacted] wants whole, fixed brains to dissect w/ summer camp students. Clinic
est. 27 and 28 wks.580
While [NM Research Doctor] appears to have conducted most of the research using
aborted infant tissue, UNM claims to have identified eleven (11) medical students or residents
and eight (8) faculty members who participated in fetal tissue research but who may not be
named in published articles.581 Further, documents produced to the Panel indicate that the
Pediatrics and Neonatology departments sometimes partner with researchers from other
departments as well.582
UNMHSC also shares tissue that it acquires with other researchers, including [o]ne
researcher . . . at the University of South Florida (previously worked at University of Alabama,
Birmingham and University of Illinois, Chicago), the University of Ottawa in Canada
(previously worked at University of Edmonton), and at the University of California San
Francisco. UNMHSC maintains that no consideration is exchanged for the tissue as part of
these collaborative research projects.583 UNM provided the Panel with emails between
UNMHSC staff and researchers at other institutions. For instance, one UNM researcher wrote to
a researcher in Edmonton, We will try to get later gestation lung for you, sometimes we can get
up to 20-22 weeks, but it is unusual these days to get non-digoxin exposed samples beyond 18
weeks (i.e., no living tissues).584
UNMHSC represented to the Panel that it bears the cost for shipping tissue domestically
while for transactions in Canada, the Canadian researcher provides a Federal Express account
number.585 After the Panels chief counsel subsequently sent a letter to UNM requesting more
complete records that would reflect other entities transactions with UNM, budgets, IRB
approvals, and late-term abortion activity at UNM, the university responded with a 60-page
production, of which 35 pages are Federal Express and other courier records with names
redacted and 21 pages are entirely redacted with no content visible at all.586 This leaves the Panel

factor-1 expression in the mid-trimester human fetus; (8) Pediatr Res. 1995 Jun.;37(6):806-11. Neutrophil pool sizes
and granulocyte colony-stimulating factor production in human mid-trimester fetuses.
579
UNM Documents [UNM00768-UNM00785, UNM00815-UNM00817 & UNM01059], Exhibit 6.29.
580
Procurement notes [UNM00024], Exhibit 6.25.
581
UNM Response to House Select Investigative Panel Subpoena 2 (Mar. 3, 2016), Exhibit 6.22.
582
See Emails with the UNM College of Pharmacy Dept. of Pharmaceutical Sciences [UNM01071-UNM01075,
UNM01078-UNM01083], Exhibit 6.30.
583
UNM Second Submission, at 1, Exhibit 6.19.
584
Email from UNM to University of Edmonton [UNM00910], Exhibit 6.31.
585
UNM Second Submission, at 1, Exhibit 6.19.
586
Letter from T. March Bell, Chief Counsel and Staff Director, House Select Investigative Panel, to UNM (Nov.
18, 2016), Exhibit 6.32; UNM Documents [UNM03457-UNM03516], Exhibit 6.33.

245

with an incomplete picture of UNMs monetary arrangements with other institutions and its IRB
approval process, assuming one even exists.
In its responses to the Panel, SWWO has asserted that it does not participate in
research, study, or other work involving fetal tissue.587 Evidence collected by the Panel,
however, calls into question whether that statement is a misrepresentation by SWWO. In one
letter UNM produced to the Panel, for example, [NM Research Doctor] wrote to [NM Doctor #3]
that we realized how valuable it would be to be able to match the individual patients blood to
the fetal tissue obtained. . . . we would need your help in matching the blood to the fetal
tissue.588 Another UNM document refers to the translational research efforts of the DREAM
Lab in collaboration with [NM Doctor #3] and the providers at Southwest Womens Options.589
SWWO medical staff was even acknowledged in a published 2015 study on the developing
human eye based upon eyeballs taken from fetuses aborted at SWWO. There the authors
thank[ed] [NM Doctor #3] and staff at Southwestern Womens Options . . . for technical
assistance.590 Thus, both internal and published documents suggest that the clinic and its
personnel, especially [NM Doctor #3], did in fact participate in fetal tissue research beyond
supplying the tissue to UNM.
13. UNM and SWWOs Failure to Properly Obtain Consent
From the Panels investigation, it is apparent that there were several deficiencies in the
consent process used to procure fetal tissue. Although both SWWO and UNM provided the
Panel a consent form that purported to give patients notice that tissue from their pregnancies
would be donated to UNM,591 there is evidence that this form was not used. While [Clinic A Dr.
#1] testified that SWWOs practice was to provide women an opportunity to donate the tissue
that resulted from their abortions and to obtain their consent to do so, she admitted she had never
gotten a consent from a patient at SWWO to make a fetal tissue donationand did not even
recognize the consent form that SWWO and UNM produced to the Panel.592 She also admitted
she was unaware of whether consent was required prior to the donation of fetal tissue.593
Further evidence supports the inference that patients were not regularly given a fetal
tissue donation consent form at SWWO. [NM Patient], a woman who obtained an abortion from
SWWO, has brought suit against the clinic and attested in an affidavit that she was never given a

587

Letter from SWWO to House Select Investigative Panel 1 (Nov. 30, 2016), Exhibit 6.34. SWWO purported to
quote from the SWWO letter responding to document request (Feb. 12, 2016), at Appendix A, but this language
does not appear in that document.
588
UNM Document [UNM00562], Exhibit 6.35.
589
UNM Document [UNM00812], Exhibit 6.27.
590
Human Eye Study at 7.
591
Client Information for Informed Consent, Donation of Fetal Tissue for Medical Research [SWWO000524],
Exhibit 6.36. UNM produced the same form with Bates number UNM01103.
592
[Clinic A Dr. #1] Tr. at 162-63, 165-67, 188-89, 212-13. The consent form itself was marked twice during [Clinic
A Dr. #1]s deposition, as Ex. 6 without a Bates number and as Ex. 12 with Bates number SWWO000524, the
version the clinic produced to the Panel. Id. at 164-65, 212-13. [Clinic A Dr. #1] maintained it was the job of a
counselor rather than a doctor to obtain a consent. Id. at 190.
593
[Clinic A Dr. #1] Tr. at 273.

246

consent to donate tissue that was separate from the consent for the [abortion] procedure.594
Moreover, she alleges she was never informed by the doctors and staff at SWWO that her
infants remains were to be donated to UNM or another entity.595 Neither, she alleged, was she
informed of the nature and extent of any use of such remains, which body parts were going to
be used or donated, or what benefits could be expected from such use.596 She added that she
was not informed by SWWO doctors or staff that the doctor who treated her, [NM Doctor #5],
and the director of SWWO, [NM Doctor #3], were volunteer faculty members at UNM, or that
the clinic and the university had been collaborating on fetal tissue research since 1995.597
Even more problematically, the only semblance of consent SWWO allegedly sought from
[NM Patient] for fetal tissue research was a phrase mentioning the use of tissue and parts . . . in
medical research within a two-page consent form provided to her for the abortion procedure
itself.598 Thus, the only consent sought from her for fetal tissue donation came during what
should have been a separate process of consent to the abortion procedure itself.
A letter from [NM Patient] to SWWO dated December 2, 2015, requested all
information regarding the disposal, donation or sale of any medical waste, but she allegedly
never received any records regarding the disposition of her infants remains.599 Moreover, none
of SWWOs or UNMs productions of documents to the Panel included the two-page consent
form submitted to the Panel by [NM Patient] through her attorney. In September 2016, [NM
Patient] read procurement notes dated October 17, 2012, that were attached to the Panels
referral of UNM and SWWO to the Attorney General of New Mexico that indicated brain tissue
had been taken from one infant estimated at 11.5 weeks gestation and another at 12.7 weeks
gestation.600 Because [NM Patient]s ultrasound taken on October 5, 2012, stated she was 12
weeks and two days pregnant, and because she obtained her abortion five days later on October
10when staff informed her she was between 12 and 13 weeks pregnantshe believed her
baby was one of the two babies given to the University of New Mexico for their research.601
This belief is consistent with SWWOs practice of storing fetal tissue in an on-site freezer until it
is periodically picked up for transfer to UNM.602 [NM Patient] attested, If I had known my baby
was going to be used for research I would have probably changed my mind about going through
with the abortion, and added that the actions of SWWO and its doctors caused her emotional

594

Affidavit of [NM Patient], Nov. 18, 2016 ([NM Patient] Aff.), 30, Exhibit 6.37. See also Complaint 47, [NM
Patient] v. [NM Doctor #3], No. _____-CV-__________ (N.M. Dis. Ct. Bernalillo County Nov. 30, 2016) ([NM
Patient] Compl.), Exhibit 6.38. In an email dated Nov. 28, 2016, [NM Patient] gave permission to the Panel to
disclose her identity publicly. Nonetheless, her name is not disclosed in the instant report.
595
[NM Patient] Aff. 10; [NM Patient] Compl. 32.
596
[NM Patient] Aff. 21-22, 26; [NM Patient] Compl. 35-38.
597
[NM Patient] Aff. 15, 18-20; [NM Patient] Compl. 32.
598
[NM Patient] Aff. 8 & Ex. A, at 1; [NM Patient] Compl. 11-12 & Ex. A.
599
[NM Patient] Aff. 32-33 & Ex. B; [NM Patient] Compl. 54-57.
600
Compare [NM Patient] Aff. 35-36 and Procurement notes, UNM00029, Exhibit 6.25. See also [NM Patient]
Compl. 52.
601
[NM Patient] Aff. 7, 12-13, 37-38; [NM Patient] Compl. 49-53.
602
SWWO letter responding to document request (Feb. 12, 2016), at 5; [Clinic A Dr. #1] Tr. at 182-85. According to
SWWOs Feb. 12 letter, pickup occurred weekly, but as noted above, procurement notes record that pickup occurred
an average of 39 times per year since 2010, 45 times in 2012.

247

distress and mental anguish.603 [NM Patient] additionally alleged that she was advised by staff
that she could apply for Medicaid funding for her abortion procedure and that the paperwork
supporting such funding was prepared by a doctor she never saw, [NM Doctor #6], and not her
treating physician, [NM Doctor #5].604
14. The Panels Criminal Referrals of UNM and SWWO
c) The June 2016 Referral
On June 23, 2016, the Panel sent a criminal referral of UNM and SWWO to the Attorney
General of New Mexico that cited both state and federal law. New Mexicos Jonathan Spradling
Revised Uniform Anatomical Gift Act (Spradling Act)605 is based on the Uniform Anatomical
Gift Act (UAGA),606 which is adopted in some form in every state. The Spradling Act was
enacted in 2007 to replace the States existing Uniform Anatomical Gift Act607 with provisions
mirroring the UAGA.608
The Spradling Act, like the UAGA, includes stillborn infants and fetuses in the definition
of decedent for purposes of obtaining consent from a relative before the deceased infants body
is donated for experimentation or transplantation. In the official notes to the UAGA, the drafters
explain that the inclusion of stillborn babies and fetuses ensures that they receive the statutory
protections conferred by this [Act]; namely that their bodies or parts cannot be used for
transplantation, therapy, research, or education without the same appropriate consents afforded
other prospective donors.609
However, the notes also mention that states may choose to treat aborted fetuses
differently, given the complicated legal, scientific, moral, and ethical issues which may
arise.610 That is exactly what the State of New Mexico chose to do in 2007. In the Spradling
Act, decedent means a deceased individual whose body or part is or may be the source of an
anatomical gift. It includes a stillborn infant and . . . a fetus but [does] not includ[e] a fetus
that is the subject of an induced abortion.611
Further, the Spradling Act provides that the Act applies to an anatomical gift or
amendment to, revocation of or refusal to make an anatomical gift, whenever made.612 In other
603

[NM Patient] Aff. 39, 42; [NM Patient] Compl. 60, 142.
[NM Patient] Aff. 14-17; [NM Patient] Compl. 61-64, 110.
605
N.M. Stat. Ann. 24-6B-1, et seq.
606
Revised Uniform Anatomical Gift Act (2006) (last revised or amended in 2009), National Conference of
Commissioners on Uniform State Laws,
http://www.uniformlaws.org/shared/docs/anatomical_gift/uaga_final_aug09.pdf [hereinafter UAGA].
607
N.M. Stat. Ann. 24-6A-1 et seq.
608
See Fiscal Impact Report, Revised Uniform Anatomical Gift Act (Mar. 14, 2007), at 3,
https://www.nmlegis.gov/Sessions/07%20Regular/firs/HB1276.pdf.
609
UAGA at 14.
610
Id.
611
N.M. Stat. Ann. 24-6B-2 (emphasis added).
612
N.M. Stat. Ann. 24-6B-3.
604

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words, all anatomical gifts in the State of New Mexico must comply with this act, and the bodies
or body parts of aborted infants cannot be anatomical gifts.
SWWOs provision and UNMs acquisition of and research using aborted infant remains
appears to violate the Spradling Act, which prohibits making an anatomical gift of the remains of
any fetus that is the subject of an induced abortion.613 Even to the extent SWWO does use the
fetal tissue donation consent form it produced to obtain consent from mothers of aborted infants,
it still would not validate the donation of their infants remains for research, because under the
Spradling Act the bodies or parts of aborted infants may not be anatomical gifts.
UNM claims to have a comprehensive Code of Ethical Conduct and compliance
programs in the area of research involving tissue obtained from fetuses.614 Further, the
university maintains that [o]versight for all research at UNMHSC is provided in the form of
Institutional Review Boards, which ensure that all federal regulations and laws are followed
regarding research studies and that UNMHSC has accreditation by the American Association
of Human Research Participation.615
However, UNMs submissions to the Panel do not address compliance with the Spradling
Act. Their efforts to conduct fetal tissue research in compliance with ethical standards and
federal laws do not make UNM and SWWO less culpable for violating New Mexico state law.
All anatomical gifts made in New Mexico must comply with the Spradling Act. Based on the
information obtained and reviewed by the Panel, SWWOs provision of tissue from aborted
infants, and the reception and use of the tissue by UNMHSC, arguably violates the Spradling
Act.
Section 289g-2 is also implicated by the relationship between the two entities because of
the value exchanged between them. As the clinic that provided abortions, SWWO incurred no
extra expense in connection with the fetal tissue it transmitted to UNM, so there were no
expenses to be reimbursed to SWWO. Indeed, the clinic might have been saved the expense it
otherwise would have borne of disposing of the tissue that UNM received. While UNM may not
have paid SWWO a sum of money it explicitly classified as consideration for the fetal tissue it
received, UNM did provide SWWO a substantial value in the form of personnel offered to the
clinic. The UNM Fellowship provided SWWO with medical personnel that expanded the volume
of abortions it could provide without SWWO having to compensate them. UNM additionally
conferred upon at least three staff physicians at SWWO faculty positions that gave them
professional liability insurance coverage for UNM activities and access to numerous university
facilities, in addition to numerous discounts. These faculty members in turn provided UNM no
apparent benefit apart from the fetal tissue that came from SWWO, giving their relationship the
components of an exchange of fetal tissue for valuable consideration. At a minimum, the intent
and spirit of Section 289g-2 have been violated, and further investigation is necessary to
determine whether criminal prosecution of SWWO or UNM should follow.

613

N.M. Stat. Ann. 24-6B-2.

UNM Second Submission, at 2, Exhibit 6.19.
615
Id. (emphasis added).
614

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d) The December 2016 Referrals

On December 21, 2016, after evidence of the failure of SWWO and UNM to provide
informed consent were supplemented by the direct allegations of [NM Patient], the Panel sent
another criminal referral to the Attorney General of New Mexico. If true, her allegation that the
only informed consent to tissue donation sought from her was the cursory reference to the use of
tissue and parts . . . in medical research in SWWOs abortion consent form amounts to
violations of federal and state law by UNM and SWWO.
HHS regulations, which govern much of the human subject research conducted at UNM,
requires in 45 C.F.R. 46.116 a number of basic elements of informed consent:
(1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the
subjects participation, a description of the procedures to be
followed, and identification of any procedures which are
experimental;
(2) A description of any reasonably foreseeable risks or discomforts
to the subject;
(3) A description of any benefits to the subject or to others which
may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation
as to whether any compensation and an explanation as to whether
any medical treatments are available if injury occurs and, if so, what
they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects rights, and
whom to contact in the event of a research-related injury to the
subject; and
(8) A statement that participation is voluntary, refusal to participate
will involve no penalty or loss of benefits to which the subject is
otherwise entitled, and the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is
250

otherwise entitled.616
According to [NM Patient]s allegations, both SWWO and UNM failed to provide any of these
elements of informed consent, in violation of 45 C.F.R. 46.116, accompanied by a violation of
45 C.F.R. 46.117 for failing to present such consent in writing.
To the extent the research of the fetal tissue acquired by UNM related to transplantation
for therapeutic purposes, any violations by SWWO and UNM would include violation of 42
U.S.C. 289g-1(b)(1), which requires written consent from the woman acknowledging the
nature of the research, the lack of restriction regarding the identity of individuals who may be
the recipients of transplantation of the tissue, and that the woman was not informed of any such
recipients identities. Moreover, the use of a consent form that simultaneously seeks consent for
abortion and for fetal tissue donation under the alleged circumstances would appear to violate
289g-1(b)(2)(A)(i), which requires the abortion consent to be obtained prior to requesting or
obtaining consent for a donation of the tissue . . . .
UNMs own oversight policy provided as of 2015 that appropriate informed consent by
the mother is required for [t]he collection and storage of all fetal tissue for research.617 The
policy as revised April 11, 2016, further clarifies that UNMHSC
will not acquire such fetal tissue from outside entities (a) without
contractual and/or written assurance that the fetal tissue being
acquired was collected in accordance with a process that separates
the informed consent for the abortion procedure from the informed
consent to donate such fetal tissue to the UNM HSC for Research,
and (b) where there is contractual assurance that the terms of the
acquisition complies fully with Section 112(a) of the NIH Act (42
U.S.C. 289g-2(a)). In addition, the contractual assurance
contemplated in Subsection 2 must indicate that there are no legal,
ethical, or other restrictions against transferring the Research
Tissues to the UNM HSC, nor against the UNM HSCs use of
them.618
UNM did not produce this revised policy to the Panel.
Despite SWWOs inclusion of a fetal tissue donation consent form in its production, [NM
Patient]s allegation that it was never shown to her, combined with [Clinic A Dr. #1]s admission
that she did not even recognize the form and had never obtained consent to donate, raises a
616

45 C.F.R. 46.116(a). These elements are the minimum required, subject to exceptions for public benefit or
service programs under 46.116(c) and potentially additional requirements under 46.116(b).
617
UNMHSC, Oversight of Human Tissue in Research, Policy # RC.05.002.PP (Sept. 16, 2015) [UNM03420UNM03428, at UNM03423], Exhibit 6.39.
618
UNMHSC, Oversight of Human Tissue in Research, Policy # RC.05.002.PP 3 (Apr. 11, 2016), Exhibit 6.40. This
revised policy additionally reinforces the Panels June 23, 2016, referral regarding violation of the Spradling Act by
requiring that fetal tissue for research be acquired in accordance with the provisions of the Spradling Act and/or
with contractual assurance that it was obtained in accordance with that statute. Id. at 3-4.

251

serious question as to whether SWWO and UNM systematically violated the law, not to mention
UNMs own internal policy, by conducting fetal tissue donations without more than the
perfunctory reference to tissue research in SWWOs abortion consent form.
The same alleged deficiencies in the consent process at SWWO would constitute a
violation of New Mexicos state law. Regardless of whether government funding or
transplantation research is involved, N.M. Stat. Ann. 24-9A-5, which is part of the Maternal,
Fetal and Infant Experimentation Act, prohibits any clinical research activity involving fetuses,
live-born infants or pregnant women unless the woman
has been fully informed of the following:
(1) a fair explanation of the procedures to be followed and their
purposes, including identification of any procedures which are
experimental;
(2) a description of any attendant discomforts and risks
reasonably to be expected;
(3) a description of any benefits reasonably to be expected;
(4) a disclosure of any appropriate alternative procedures that
might be advantageous for the subject;
(5) an offer to answer any inquiries concerning the procedure;
and
(6) an instruction that the person who gave the consent is free to
withdraw his consent and to discontinue participation in the
project or activity at any time without prejudice to the subject.619

619

N.M. Stat. Ann. 24-9A-5(C). As discussed above, the Spradling Act prohibits use of fetal tissue resulting from
induced abortion, but this informed consent provision provides a basis for liability separate from the underlying use
of such tissue. It additionally should be noted that the Maternal, Fetal and Infant Experimentation Act defines the
term clinical research as follows:
clinical research means any biomedical or behavioral research involving human
subjects, including the unborn, conducted according to a formal procedure. The
term is to be construed liberally to embrace research concerning all physiological
processes in human beings and includes research involving human in vitro
fertilization, but shall not include diagnostic testing, treatment, therapy or related
procedures conducted by formal protocols deemed necessary for the care of the
particular patient upon whom such activity is performed and shall not include
human in vitro fertilization performed to treat infertility; provided that this
procedure shall include provisions to ensure that each living fertilized ovum,
zygote or embryo is implanted in a human female recipient, and no physician may
stipulate that a woman must abort in the event the pregnancy should produce a
child with a disability. Provided that emergency medical procedures necessary to
preserve the life or health of the mother or the fetus shall not be considered to be
clinical research . . . .
N.M. Stat. Ann. 24-9A-1(D).

252

This statute is notably cited in the standard operating procedures of UNMs Office of the
Institutional Review Board, but UNM failed to produce that document to the Panel.620 Other
sections of the Maternal, Fetal and Infant Experimentation Act make clear that neither a pregnant
woman nor a fetus shall be involved as subjects in clinical research activity unless the mother is
legally competent and has given her informed consent,621 subject to penalties of imprisonment
for less than one year and/or payment of a fine up to $1,000.622
C. The University of Washington and the Nations Largest Fetal Tissue Bank
6. Summary
The Panels investigation into the nations largest fetal tissue bank at the University of
Washington (UW) and outside abortion clinics provides another example of the interdependence
of clinics and public research institutions. Over the last five years, over a dozen clinics have
provided UW fetal tissue, and 40 universities or other public research institutions have been
recipients of fetal tissue. UW claims that recipients of tissue are charged a flat fee of $200
regardless of the nature of the tissue researched and that the only payments it makes to clinics are
to cover costs. The university failed to make a complete production, however. The Panels
independent research found that UW deploys doctors to outside abortion clinics and that
numerous physicians on the staffs of those clinics hold faculty positions at UW. The invoices
produced by UW are heavily redacted, rendering it impossible without more information to
conduct a full forensic analysis under 289g-2 of payments made to and by UW in connection
with transfers of fetal tissue.
7. The University of Washington, in Conjunction with Numerous Clinics, Establishes the
Nations Largest Fetal Tissue Bank
UW offers an illustration of a universitys relationship with numerous abortion clinics as
sources of fetal tissue, with a substantial research operation funded by the federal government.
The UW School of Medicine manages and operates the Birth Defects Research Laboratory (UW
BDRL), which contains the largest fetal tissue bank in the nation. UW BDRL received over
$600,000 from the NIH for FY 2015.623 The Panel issued UW BDRL a subpoena dated April 29,
2016, to which UW responded with a partial production. The university claimed in response to
six subpoena items it could not yet produce more [d]ue to the breadth of the Subpoena, but that
responsive documents would be provided as soon as possible.624

620

See UNM Office of the Institutional Review Board, Standard Operating Procedures, effective Mar. 1, 2016, at 12,
http://irb.unm.edu/sites/default/files/511.0%20Compliance%20with%20Applicable%20Laws%20and%20Regulatio
ns.pdf, Exhibit 6.41.
621
N.M. Stat. Ann. 24-9A-2(B), 24-9A-3(B).
622
N.M. Stat. Ann. 24-9A-6.
623
NIH research portfolio, https://projectreporter.nih.gov/project_info_description.cfm?aid=8882485&icde=0,
Exhibit 6.42.
624
UW responses to subpoena, Exhibit 6.43.

253

The documents UW BDRL produced did not include any contracts with donors or
recipients of fetal tissue, but it did provide a list of such donors and recipients. Over the previous
five years, UW BDRL has procured fetal tissue resulting from abortion from a number of clinics
and hospitals, including at various times the following (with an asterisk * noting fetal tissue
sources identified by UWs IRB as current in 2016):
3. All Womens Health-North*
4. Cedar River Clinic-Renton*
5. Cedar River Clinic-Tacoma*
6. Cedar River Clinic-Yakima*
7. Evergreen Medical Center*
8. Planned Parenthood of Greater Washington and North Idaho (PPGWNI)*
9. Seattle Childrens*
10. Seattle Medical and Wellness Clinic*
11. University of Washington Medical Center*
12. Allentown Womens Center
13. Group Health Cooperative
14. Harborview Medical Center
15. Swedish Medical CenterEdmonds625
UW BDRL also produced a list of 40 universities or other research institutions to which it
has provided fetal tissue between 2010 and 2015:
1. Allen Institute for Brain Science
2. Cedars Sinai Medical Center
3. Childrens Hospital of Philadelphia
4. Childrens Mercy Hospital
5. Childrens National Medical Center
6. Cold Spring Harbor Laboratory
7. Duke University
8. Fred Hutchinson Cancer Research Center
9. Harvard University
10. Indiana University
11. Johns Hopkins University
12. Lady Davis Institute
13. McGill University
14. Medical College of Georgia
15. New York StateDepartment of Health
16. NIH
17. Oregon State University
18. Pacific Northwest National Lab
625

UW first production [000002-000008], Exhibit 6.44. Aurora Medical Services, sometimes listed as a source, was
acquired by the Cedar River Clinics. Note that Pacific Northwest Facility and Seattle Reproductive Medicine are
also sources of fetal tissue, but they only provide tissue from pregnancy losses, not elective abortions. Id. at
[000008].

254

19. The Rockefeller University

20. Scripps Whittier Institute
21. Stanford University
22. Temple University
23. UCLA
24. UC Merced
25. UCSD
26. University College London
27. University of British Columbia
28. University of KentCanterbury
29. University of Michigan
30. University of Miami
31. University of Nebraska
32. University of North Texas
33. University of Pittsburgh
34. University of Puerto Rico
35. University of South Carolina
36. University of Washington
37. University of Wisconsin
38. US Environmental Protection AgencyVirginia
39. Washington University
40. Yale University626
8. The Sharing of Personnel Between UW and Outside Clinics That Supply Tissue
Through information available outside UW BDRLs production, the Panel has learned
that, as in the case of UNM in Albuquerque, the university maintains a close relationship with
area abortion clinics that includes the deployment of medical students to the clinics and faculty
status for the clinics staff physicians. Besides providing abortions directly through its family
planning program, UW participates in the Kenneth J. Ryan Residency Training Program in
Abortion and Family Planning, which provides residents to outside abortion clinics.627 Several
faculty members perform abortions not only at UWs Medical Center, but also at outside clinics,
several of which perform abortions at least well into the second trimester and raise questions
about the standard of care for infants who survive the abortion procedure.
It is also noteworthy that a set of talking points produced to the Panel by the Allentown
Womens Center designed to encourage women to give their consent to donate their infants
tissue misrepresents the necessity for fetal tissue research, including the following claims:

Research that requires fetal tissue includes: Alzheimer's, Multiple sclerosis,

Prostate and lung cancers, Diabetes, Spinal cord regeneration, Arthritis,

626

UW first production [000010-000015], Exhibit 6.45.

See The Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, Map and locations,
http://www.ryanprogram.org/map-and-locations; Fellowship in Family Planning, Where are the Fellowships
located?, http://www.familyplanningfellowship.org/fellowship-programs, Exhibit 6.46.
627

255

Parkinsons, Brain tumors, Neuropathy of HIV, Macular degeneration,

Osteoarthritis, Sickle-cell anemia, Hepatitis and liver regeneration, Respiratory
distress syndrome, and Blindness.

You have already made a heart-wrenching decision. We know this is one more
decision to make. Only fetal tissue and stem cells can further birth defects
research. . . .

Some tissue is already being used to help regenerate spinal cells so paralyzed
people can walk someday.628

This grossly misrepresents the state of scientific research and available treatment. This
reports discussion below of biomedical research includes a survey of how much clinical
research utilizes fetal tissue.629 Not only is fetal tissue unnecessary to study the conditions listed
above; there are no current clinical trials being conducted using such tissue to research most of
those conditions, with three exceptionsspinal cord injury, macular degeneration, and
diabetesin which cases less than 1% of the trials use fetal tissue.630 Moreover, the same survey
lists ten conditions arising during fetal life that affect infants and children, and there are currently
no clinical trials for any of those conditions that use fetal tissue.631 Further inquiry is necessary
as to which personnel have made such claims in order to induce women to provide their consent
and whether such misrepresentations are limited to one clinic or extend to UW and its other
partners.
UW never produced documents sufficient to identify the doctors shared between the
university and outside clinics.632 Based upon other sources, the Panel learned of the following
examples of the close ties between UW and area clinics that provide the university fetal tissue:

The Cedar River Clinics: These clinics were co-founded by their executive
director, [WA Clinic Director], in 1979 as the Feminist Womens Health Center.
Its staff physicians include [WA Doctor #1], who had been medical director of
Aurora Medical Services, a supplier of fetal tissue to UW, between 2000 and
2014. They are a major supplier of fetal tissue, with recipients that include

Counseling suggestions for discussing tissue donation, Allentown Womens Center production, ALWC-001,
Exhibit 6.47.
629
See Chapter IX infra.
630
See Chapter IX.C, table 1.
631
Id. (diseases arising in the fetus and/or affecting children).
632
That information should have been evident if a full production were made pursuant to UW BDRLs subpoena,
including item 4: Documents sufficient to reflect UWs organization chart, including information detailing UW
personnel that procure(d) fetal tissue at the clinic level and the supervisory personnel for those procurers of fetal
tissue. UW produced only one chart listing six positions under the principal investigator at UW BDRL. UW first
production, 000017, Exhibit 6.48. The Panel followed up on September 14 with various inquiries, including requests
for a list of doctors who have performed abortions at outside clinics while affiliated with UW and a list of
doctors at outside abortion clinics who have faculty positions at UW. UWs second production, however, did not
include information sufficient to inform the Panel on these points.
628

256

StemExpress and ABR.633 The clinics perform late-term abortionsadvertising

their services up to 26 weeks:634

Among several lawsuits the clinics have faced was at least one medical
malpractice suit arising from an abortion performed at 25+ weeks by [WA Doctor
#2] that was alleged to have caused a woman excessive bleeding, threatening her
life, and necessitated an emergency hysterectomy.635 Several UW faculty
members provide abortions at the Cedar River Clinics on at least a part-time basis,
including [WA Doctor #3], associate professor of Ob/Gyn at UW and director of
UWs Family Planning Division and the Family Planning Fellowship; [WA
Doctor #4], acting assistant professor in UWs Ob/Gyn department; and [WA
Doctor #1], clinical assistant professor at UWs Family Medicine Residency.
Former Cedar River staff physician [WA Doctor #5] worked at the clinic while
simultaneously working as an assistant clinical professor, volunteer staff,
between 1999 and 2010. Former Cedar River staff physicians [WA Doctor #6],
who is now on the staff of the Swedish Medical Center, and [WA Doctor #7],
currently with Northwest Womens Healthcare, were also UW residents.

All Womens Health-North: [WA Doctor #8], owner and operator of All
Womens Health-North, which is incorporated as ABBR Enterprises, and a clinic
in Chicago also named All Womens Health, is a clinical instructor both at UWs
Family Medicine Residency and Northwestern Universitys Feinberg School of
Medicine. All Womens Health-North conducts abortion training for UW
residents.636 Although he is not known to be on UW faculty, [WA Doctor #9], the
former medical director for the Cedar River Clinics, now performs abortions at
All Womens Health-North. According to the former staff member at
Germantown Reproductive Health Services interviewed confidentially by the
Panel, [WA Doctor #9] told her he would push the gestational limit of abortions
he performs as far as he could go.

PPGWNI: [WA Doctor #10], who was medical director of PPGWNI for eight
years, was trained as a UW resident and is a clinical associate professor at UWs

633

See Chapter V supra.

Abortion Clinics Online, Late Abortion Clinic, https://abortionclinics.com/clinic-category/late-abortion-clinic/.
635
Investigative Report Prepared for the Medical Quality Assurance Commission, Exhibit 6.49; Complaint, [WA
Patient] v. [WA Doctor #2] at 2-3, No. ________________ (Wash. Super. Ct. King Co., June 25, 2010); telephone
conference between Panel staff and plaintiffs attorney, Dec. 7, 2016. The case was ultimately referred to an
arbitration panel and settled.
636
Abortion in Washington blog, http://abortionstate.blogspot.com/2009/10/north-seattle-late-term-killingfield.html.
634

257

Central Washington Family Medicine Residency Program. PPGWNI doctor [WA

Doctor #11] is also a clinical faculty member at UW.
9. Fetal Tissue Research at UW BDRL
UW BDRL conducts a substantial amount of fetal tissue research. [WA Research Doctor
#1], a professor of pediatrics and author of numerous papers involving fetal tissue research, holds
several titles at UW, including director of medical genetics at Seattle Childrens and co-director
of the Alaska Genetics & Birth Defects Clinicprograms that provide virtually all of the
pediatric genetic services for the states of Washington and Alaska, according to UWs
website.637 [WA Research Doctor #1] has been the author of UW BDRLs NIH grant proposals
since at least 2005.638 [WA Research Doctor #1]s research includes a paper on optimal abortion
techniques. Among other UW personnel who have authored or otherwise assisted fetal tissue
studies639 are [WA Doctor #3]; [WA Doctor #4]; [WA Research Doctor #2] of the pediatrics
departments hindbrain malformation research program; [WA Research Doctor #3], a UW
resident; and [WA Research Staff], technical operations manager at the medical schools
WWAMI Institution for Simulation in Healthcare.
10. UWs Productions Were Insufficient for the Panel to Conduct a Full Analysis of UWs
Fetal Tissue Transactions
UW BDRL claimed in its initial response to the subpoena that it does not sell fetal
tissue. It added, however, that it makes tissue available for research use by academic and
non-profit research facilities. The recipient is invoiced a flat fee of $200. This fee is intended to
cover UWs costs associated with the technical effort and related expenses in preparing the
tissues that are not covered by the NIH grant.641 Thus, UW BDRL did not represent that no
money changes hands when tissue is received or donated, and it made no representation as to
whether it purchased fetal tissue. The cover letter accompanying the partial production did admit
that the clinics or hospitals are reimbursed for costs associated with obtaining the fetal tissue for
research.642 Analysis under 289g-2 requires clarification of the precise amounts that were
expended as well as which costs were claimed for reimbursement since only certain costs may
lawfully be reimbursed.
640

UW BDRLs initial production did not provide accounting records, invoices, other
financial records, or communications that would have permitted the Panel to analyze and make
637

Excerpt from UW Division of Genetic Medicine, https://depts.washington.edu/genediv/directory/[WA Research

Doctor #1], Exhibit 6.50.
638
Grantome entries under [WA Research Doctor #1], http://grantome.com/search?q=@author%20%20[/[WA
Research Doctor #1]], Exhibit 6.51.
639
See, e.g., ________ et al., Effects of Digoxin and Delayed Dilation and Evacuation on Fetal Tissue Quality:
Maximizing Opportunities for Research Participation, 92 Contraception 367 (2015).
640
UW responses to subpoena item 2, Exhibit 6.43.
641
UW responses to subpoena item 19, Exhibit 6.43.
642
Letter from UW School of Medicine to Panel (May 10, 2016), at 1, Exhibit 6.52.

258

an independent assessment of the money that changed hands when fetal tissue was transferred.643
This would be necessary to conduct a forensic analysis of UWs practices under 289g-2, as
would an examination of other value exchanged among various entities. The Washington
attorney general, who is also responsible for representing the university, found without
apparently conducting such analysis that PPGWNI had not received direct payment for fetal
tissue from UW.644 That offices inquiry apparently ended without an examination of an
agreement between UW and one of the nine clinics that comprise PPGWNI. In emails exchanged
between the AGs office and UW, UW representative [WA Administrator] told ADA Paige
Dietrich he could send a business associate agreement and IRB authorization agreement between
the entities, but after he asked whether they would remain confidential, Dietrich replied, I dont
think well need copies of the agreements.645
Months passed without UW BDRL following up on the production it represented in May
would be made as soon as possible. In an effort to obtain expeditiously the information most
critical to its investigation, on September 14, 2016, following several communications with
UWs attorneys in the state attorney generals office, Panel staff distilled its pending subpoena
categories to 14 specific inquiries to UW. In response, UW claimed that due to a temporary
restraining order (TRO) issued August 3, 2016, by the United States District Court for the Western
District of Washington blocking UWs release of records pursuant to a lawsuit filed under the Public
Records Act, it was unable to provide records or other information responsive to 13 of the Panels
14 inquiries.646 While the TRO was broad enough to bind state and private parties, well established
case law makes clear that any construction of the TRO that would prohibit compliance with a
validly conducted congressional investigation would violate the Constitution. Chairman
Blackburn accordingly sent a letter to the court citing such authority and requesting that the court
make clear its TRO may not be construed to preclude UWs compliance with the Panels
subpoena.647 The court issued a preliminary injunction dated November 13, 2016, that did not
address Congress specifically, but narrowed the language of the TRO to permit disclosure while
requiring redaction of personal identifying information.648 While applicable law would not bind a
party to make redactions in response to a congressional committee, the Panel, as a matter of
accommodation, permitted UW to make such redactions, provided that the production would be
accompanied by a redaction log disclosing any missing names. The log would be kept in a
locked safe within the Panels offices and accessed only if necessary to the investigation.
UW made its second production to the Panel on December 1, 2016. The vast majority of
documents produced were various invoices, and they included extensive redactions without an
accompanying redaction log. In addition to names, UW redacted identities of departments at the
643

See UW responses to subpoena items 5 (communications . . . that direct or relate to a direction to UW personnel
to procure fetal tissue), 6 (accounting records), and 8 & 10 (invoices relating to fetal tissue), Exhibit 6.43.
644
Memorandum from Deputy Attorney General and Senior Assistant Attorney General to Attorney General of
Washington (Nov. 12, 2015), at 2, Exhibit 6.53.
645
Emails (Sept. 17, 2015), Exhibit 6.54.
646
UW second set of responses, Exhibit 6.55.
647
Letter from Chairman Blackburn to Hon. James L. Robart, U.S. District Court for the Western District of
Washington, Nov. 8, 2016, Exhibit 6.56.
648
Jane Does 1-10 v. University of Washington, Case No. C16-1212JLR, Order Granting Motion for a Preliminary
Injunction and Denying Motion to File a Supplemental Hearing, (W.D. Wash. Nov. 13, 2016), at 25.

259

university involved in various transactions, shipment dates, and even (in many but not all cases)
descriptions of the tissue involved. To the extent discernible, the invoices reflect that UW
charged $200 per unit, $100 where the number of units involved was 0.5, and $300 where the
number was 1.5, but it is unclear by what methodology these fractional units would be defined if
in fact UW sets a flat fee schedule.649 UW failed to produce communications involving UW
personnel regarding fetal tissue and did not answer the Panels questions regarding doctors who
simultaneously work for the university and outside abortion clinics.
UW additionally produced 25 invoices for clinic services listing individual charges
ranging from to $521 to $2,500. The invoices either do not specify what clinic services are
involved or, when they apparently elaborate on the nature of such services, those elaborations are
redactedrendering it impossible for the Panel to conduct a forensic analysis of UWs financial
arrangements with clinics.650 UWs incomplete production raises more questions than it answers
and demonstrates the need for further investigation.
D. Planned Parenthood Gulf Coast: A University Case Study
7. Summary
The Panel conducted an investigation of Planned Parenthood Gulf Coast (PPGC), a
Planned Parenthood Federation of America (PPFA) affiliate that had its own research
department. The Panel uncovered evidence that PPGCs research department may have violated
42 U.S.C. 289g-2, Texas Penal Code 48.02, and Tex. Penal Code Title 8 37.08.
c) Background on Planned Parenthood Gulf Coast
PPGC has a research department651 that conducted studies for pharmaceutical
companies,652 the medical device industry,653 and academic institutions, mostly in Texas.654
PPGC bought its headquarters in 2010 largely because it met the needs of the research
department.655
PPGC conducts in-house fetal tissue extraction, processing, storage, and shipping.656
PPGC also ships tissue, but it requires the study sponsors to set up a FedEx account. PPGC prints
the air bill, puts the air bill on the container, places the shipment on dry ice, and either has FedEx

649

See, e.g., Invoices for tissue collection and distribution, UW second production [000388, 000397, 000399,
000400, 000402, 000418, 000420, 000424, 000425, 000431, 000432, 000442, 000449, 000450, 000455, 000485,
000503, 000508, 000519, 000526, 000567, 000569, 000571, 000582, 000583, 000591, 000623, 000627, 000641,
000646, 000653, 000666, 000667, 000669, 000677, 000680, 000699, 000700, 000860], Exhibit 6.57.
650
See Invoices for clinic services, UW second production [000941-000965], Exhibit 6.58.
651
Center for Medical Progress, Transcript, Meeting with [PP Witness #2], [PPGC Abortion Services Official],
[PPGC Staff], & Medical Assistant 4 (Apr. 9, 2015) [hereinafter CMP Meeting with PPGC personnel Tr.].
652
Id. at 5.
653
Id. at 6.
654
Id. at 35.
655
Id. at 96.
656
Id. at 9, 14, 19-20, 29; 31, 40.

260

pick up the shipments or a PPGC staffer will drop it off.657 PPGC bills customers for any sterile
supplies needed for tissue procurement.658
From 2010 through 2012, PPGC procured placenta, blood, and fetal membranes for the
University of Texas Medical Branch, Galveston (UTMB).659 PPGC also unsuccessfully
negotiated a contract to procure fetal tissue for the Baylor College of Medicine (BCM). PPGC
ended its negotiations with BCM after the CMP videotapes were released. [PP Witness #2] told
[BCM Staff] that the PPFA affiliate would not commit to contractual relations for the
procurement of fetal tissue with any Texas academic institutions, unless those institutions spoke
out about their need for fetal tissue.
The Panel has uncovered evidence that, despite those costs, PPGC may have made a
profit from its procurement of fetal tissue. On a CMP videotape, [PP Witness #2] stated this
research department generates more revenue than the entire OB GYN research program at
Baylor [College of] Medicine. . . . multiple, multiple times more revenue.660
d) History of Panels Interactions with PPGC and Related Entities
During the course of its investigation, the Panel learned that PPGC procured fetal tissue
for UTMB and BCM. On January 21, 2016, the Panel sent a document request letter to UTMB
that asked for the production of a list of all entities from which it received or to which it donated
fetal tissue, all communications related to the procurement of fetal tissue, all accounting records,
and other materials.661 During telephone conferences with UTMB officials, Panel staff agreed to
narrow the scope of the request to include only communications, invoices and purchase orders.662
UTMB produced the agreed upon documents on February 17, 2016.663
The Panel sent a document request letter to BCM that asked for the production of a list of
all entities from which it received or to which it donated fetal tissue, all communications related
to the procurement of fetal tissue, all accounting records, and other materials.664 On February 9,
2016, BCM produced documents related to fetal tissue procurement from PPGC, letters it
exchanged with the Texas Attorney General related to fetal tissue procurement, and documents

657

Id. at 19-20.
Id. at 90.
659
Documents produced by the University of Texas Medical Branch to the Panel [UTMB 239], Exhibit 6.59.
660
CMP Meeting with PPGC personnel Tr. at 90.
661
Letter from Rep. Marsha Blackburn, Chairman, Select Investigative Panel on Infant Lives to President,
University of Texas Medical Branch (Jan. 21, 2016).
662
Telephone conference between Senior Public Affairs Officer, Department of Legal Affairs, University of Texas
Medical Branch, and Panel staff (Feb. 2, 2016); Telephone conference between Senior Public Affairs Officer,
Department of Legal Affairs, University of Texas Medical Branch, and Panel staff (Feb. 10, 2016).
663
See Email from University of Texas Medical Branch official to Panel staff (Feb. 17, 2016).
664
Letter from Rep. Marsha Blackburn, Chairman, Select Investigative Panel on Infant Lives to Dean, Baylor
College of Medicine (Jan. 21, 2016).
658

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specifically requested by the Panel staff.665 BCM produced to the Panel the remaining responsive
documents on February 24, 2016.666
8. PPFA Policy on Reimbursement for Fetal Tissue Donation Programs
c) April 2001 PPFA memorandum
On April 4, 2001, several PPFA officials sent a memorandum to affiliate chief
executives, affiliate medical directors, and patient service directors, on federal regulations for
participation in fetal tissue donation programs.667 The memorandum notes that applicable federal
laws forbid the payment or receipt of valuable consideration for fetal tissue. However, they
permit reasonable payments associated with the transportation, implantation, processing,
perseveration, quality control, or storage of fetal tissue.668
The memorandum states that PPFA affiliates can choose one of two methods to comply
with these laws, as follows:
One method would be to recover no costs associated with any aspect
of participation in a fetal tissue donation program. This would mean
that all staff time, clinic space, supplies, etc., would be donated by
the affiliate, and the affiliate would receive no payments or in-kind
services from the entity to whom the tissue is being donated.
. . . The second method would be to employ an independent auditor
to conduct a credible and good-faith analysis of the actual costs
incurred by the affiliate in the transportation, implantation,
processing, preservation, quality control, or storage of the fetal
tissue and, if the research is supported by federal funds, for the
removal of the fetal tissue. Under this method, affiliates must
maintain careful records of actual tissue donations and of payments
received from the researcher or the tissue-gathering entity. Affiliates
must be able to demonstrate that the payments do not exceed the
actual costs of the actual tissue donations.
Sometimes tissue-gathering entities offer to pay rent for space
occupied by one of their employees who would be on-site at a clinic
on a regular basis. If an affiliate determines to enter into such an
arrangement, then the independent auditor would also conduct a
665

See Letter from Senior Vice-President and General Counsel, University of Texas Medical Branch, to Rep.
Marsha Blackburn, Chairman, Select Investigative Panel on Infant Lives (Feb. 9, 2016).
666
See Letter from Senior Vice President and General Counsel, University of Texas Medical Branch, to Rep. Marsha
Blackburn, Chairman, Select Investigative Panel on Infant Lives (Feb. 21, 2016).
667
Memorandum from [PPFA Lawyer], [PPFA Medical Officer #1], & [PPFA Medical Officer #2] to Affiliate Chief
Executives, Affiliate Medical Directors, & Patient Service Directors (Apr. 4, 2001) [PPFA-HOU_E&C-000149000150], Exhibit 6.60.
668
Id.

262

credible and good-faith computation of the actual cost of the space

occupied by the tissue-gathering entity employee, in order to
determine the amount of rent to be paid by that entity.669
The memorandum goes on to remind affiliates that, in addition to the federal laws outlined
above, there are laws in many states governing fetal tissue donation programs. Affiliates must
take great care to assure compliance with those laws as well.670
[PP Witness #2] testified that she had seen the original. Despite that knowledge, the Panel
has learned that the costs included in PPGCs contract and proposed contract with UTMB were
based not on an independent auditors credible and good-faith analysis of the actual costs it
incurred to procure fetal tissue for UTMB. [PP Witness #2] testified that the costs were
basically back of the envelope type calculations that she derived.671 Rather it was based on
back-of-the-envelope calculations by a single PPGC official. The fact that PPGC ignored the
long-standing advice of PPFAs legal director when it drafted the UTMB contract and proposed
amendment goes directly to PPGCs knowledge of the duty to comply with the applicable law
and its willful decision to ignore the legal advice of its organization.
d) January 2011 redistribution of PPFA memo
The April 2001 memorandum was redistributed to PPFA affiliates in January 2011 under
the signature of [PP Witness #1].672 The memorandum sought
. . . to remind affiliates about the federal law relating to payment for
participation in such programs. The attached memo was sent almost
exactly 10 years ago (yikes!). Given the time that has elapsed and
that there has likely been staff turnover, we thought it would be
helpful to resend it to assure continuing compliance with the
statutes.673
Thus, PPFA affiliates, including PPGC, were twice put on notice about the steps they
would have to undertake in order to participate in a fetal tissue donation program, and to ensure
that any reimbursable costs they received did not constitute valuable consideration under the
applicable federal and state laws.
9. PPGC Relationship with University of Texas Medical Branch
According to its production, from 2010 through 2012, PPGC procured non-fetal tissues
from UTMB, which it admitted included maternal tissues such as blood, placenta, and fetal
669

Id.
Id.
671
Transcribed Interview of [PP Witness #2] at 26 (Oct. 19, 2016).
672
Memorandum from [PP Witness #1] to Affiliate CEOs, Medical Directors, & Patient Services Directors (Jan. 26.
2011) [PPFA-HOU_E&C-000148], Exhibit 6.61.
673
Id.
670

263

membranes (i.e., amniotic sac). PPGC continued, No fetal tissues were acquired by UTMB
from [PPGC] as part of these transactions.674 During her transcribed interview, however, [PP
Witness #2] testified that the UTMB study involved fetal tissue:
The last research study that required the collection of first trimester
fetal tissue was with the University of Texas Medical Branch. PPGC
supplied pregnancy tissue for that study, which focused on a
molecule called dystroglycan on placentas in an effort to prevent
miscarriages. That research study ended in 2011.675
[PP Witness #2] testified that placenta is fetal tissue:
[Q]: The placenta is a fetal or maternal organ; which is it?
. . . A: It's a fetal organ, if I remember my training in nursing school
correctly.676
PPGC personnel generally obtained consent from patients to donate fetal tissue. Emails
produced by UTMB indicate that its personnel also obtained consent from patients and procured
the fetal tissue.
a) PPGC Procures Fetal Tissue for UTMB
In September 2010, [UTMB Researcher # 1] sent an email to [PPGC Executive] that
stated:
So sorry for interrupting your Saturday. I generally am not one to go
outside the chain of command, but Im getting nowhere with this
study that has been IRB approved since April. . . . It is essentially
the same as the protocol we have been using for collection of
chorionic villi, except that it calls for collection of one tube of blood
at the time of IV start and also decidua at the time of CV collection.
We provide all supplies, and my technician can do all the recordkeeping,
My previous study has been going well, and I dont think it has
disrupted the flow of [the] clinic significantly. I have not received
any invoice for the consents of 20 subjects, but the fee is negotiable.

674

Documents produced by the University of Texas Medical Branch to the Panel [UTMB 239], Exhibit 6.59.
Transcribed interview of [PP Witness #2] at 11 (Oct. 19, 2016).
676
Id. at 83.
675

264

We are hoping to establish and maintain a long-term relationship for

collection of first and second trimester tissue for our studies . . . .677
[PP Witness #2] replied to [PPGC Executive]:
If its all the same to you, Id prefer that you bounce the topic back
to me knowing the following issues:
1. The study is not essentially the same. It now involves acquiring
maternal blood, and the original contract is only for fetal tissue.
2. The original budget for the original study compensates PPGC only
for the staff time obtaining informed consent. However the prep for
sample collection entails sterile POC [Products Of Conception], and
is more involved than prior tissue studies. SS actually brought this
issue up with me. [PPGC Abortion Services Official] and I have had
sporadic discussions about this, but havent had time to formally
discuss an appropriate budget. We are planning to meet this
afternoon so I can bring a more realistic budget to [UTMB
Reseacher # 1].
3. This study will require a separate contract and budget from the
original study.678
UTMB did not produce to the Panel the original study or any related documents.
On October 1, 2010, [UTMB Researcher #1] wrote to [PP Witness #2] that I deserve to
know where we stand and what our potential timelines are.679 [PP Witness #2] replied:
Well need to draw up a new contract, as the prior one was only for
fetal tissue. We will only be able to enroll clients who get IV
sedation into the study with the blood draw, otherwise it is not
standard of care and the current ICF doesnt address the risk of a
study-related blood draw.
We need to renegotiate the budget for both studies based on
feedback from SS. I met with SS mgmt last week and here is their
proposal:
$50 enrollment/consent process (consent per PPGC SOP, physician
statements)

677

Email from [UTMB Researcher # 1] to [PPGC Executive], [UTMB 320-UTMB 325 at UTMB 324-UTMB 325],
Exhibit 6.62.
678
Id. at [UTMB 323].
679
Id. at [UTMB 322].

265

$100 room set up/collection (strip machines, sterile equipment, rinse

hosing with sterile water, biologic sample collection)
$50 enrollment/consenting fee if tech leaves without tissue (staff
performed the work and tech didnt/couldnt stay to collect sample).
$2000 annual admin fee (new or retraining staff, SS and Research
Mgmt oversight, consent storage, supply storage).
It would also be preferable if we amended the contracts to provision
$Xamount/yr for a spend-down grant. PPGC is paid in advance for
a set number of samples/yr, and then you collect at will . . . .
Fee TBD I was informed that you need help getting some of your
supplies. I can check with our purchasing manager to see if we can
do this, but I will need a list of supplies. The more detailed, the better
such as manufacturer, product number, etc.
Going forward Ill need to add these terms to the contract for the
tissue-only study, and have both parties resign. Ill need to create a
new contract for the blood&tissue study we can copy and edit the
original one to expedite the process. PPFA approval of the
blood/tissue study will be expedited once we get this in order.680
[UTMB Researcher #1] replied, Thats fine . . . . [UTMB Researcher #2] will be the one to sign
off and pay for his study that Im collaborator on, and I will sign the new contract for my study.
Can we split the $2000 admin fee between us? Or will it be faster just to list UTMB and do the
accounting on our end?681 On November 15, 2010, [PP Witness #2] sent an email to [UTMB
Researcher #1] that stated, I am waiting for CEO signature on the amended contract. Ill email
you a copy once hes signed it.682
Invoices produced to the Panel by UTMB show that PPGC billed UTMB a total of
$21,424.98 in annual administrative fees, consent payments, staff training, and supplies.683 The
Panel cannot determine whether those payments were made pursuant to first or the second
contract.
On September 2, 2011, [PP Witness #2] sent an email to [UTMB Staff], the
administrative assistant to [UTMB Researcher #2], who took over as the researcher on the
680

Id. at [UTMB 321-22].

Id. at [UTMB 321].
682
Email from [PP Witness #2] [UTMB Researcher # 1] (Nov. 17, 2010) [UTMB 326], Exhibit 6.63.
683
Invoice from Planned Parenthood Gulf Coast to University of Texas Medical Branch (Nov. 11, 2010,) [UTMB
328]; Invoice from Planned Parenthood Gulf Coast to University of Texas Medical Branch (Nov. 11, 2010) [UTMB
329]; Invoice from Planned Parenthood Gulf Coast to University of Texas Medical Branch (June 11, 2011) [UTMB
344]; Invoice from Planned Parenthood Gulf Coast to University of Texas Medical Branch (Sept. 29, 2011) [UTMB
252], Exhibit 6.64.
681

266

UTMB-PPGC project.684 In her email, [PP Witness #2] stated, Attached is the draft revised
contract. Please review and return edits to me with tracked changes.685 A version of the
proposed contract, which was signed by [UTMB Researcher #2] but not by PPGC,686 stated that
PPGC will consent up to 500 patients.687 UTMB would have paid $150 per consent ($50 for
[s]taff time expense involving informed consent and relevant study documentation, plus $100
for [s]terile procedure room set-up, sample preparation (strip machines, sterile equipment, rinse
hosing with sterile water), biological specimen collections (ie blood, urine; non-fetal tissue)
performed by staff).688
The draft contract stipulated:
Per calendar year . . . Planned Parenthood is expected to obtain at
least 25 executed informed consents at One Hundred Fifty Dollars
($150.00) each for a total of Seven Thousand Five Hundred Dollars
($3,750.00) [sic]. If within the course of the year the need arises for
additional subject enrollment beyond 25, this number can be
increased with mutual agreement by both parties, and an amendment
to this agreement.
[UTMB Researcher #2] will reimburse Planned Parenthood for
actual number of fully executed informed consents, regardless of if
a sample is obtained, at the rates above with the following payment
schedule.
I. Annually in October, [UTMB Researcher #2] will pay Planned
Parenthood 100% of the expected 25 executed informed
consents.
ii. Should the number of consents exceed 25, Planned Parenthood
will invoice [UTMB Researcher #2] for these additional costs on a
monthly basis. [UTMB Researcher #2] will pay Invoices within 30
days of receipt.
iii. Failure to pay invoices will result in immediate halt to study
enrollment.689
In addition to the fee for each executed informed consent, UTMB would have paid PPGC
an annual administrative fee of $2,000, and $1,500 for expenses related to staff time utilized in
CITI Training as required by the UTMB Institutional Review Board. This reimbursement will be
684

Transcribed interview of [PP Witness #2] at 63 (Oct. 19, 2016).

Email from [PP Witness #2] to [UTMB Staff # 1] (Sept. 7, 2011) [UTMB 314], Exhibit 6.65.
686
Tissue Supply and Biological Specimen Agreement, Amendment No. 2, between Planned Parenthood Gulf Coast,
Inc. and [UTMB Researcher #2] of UTMB (July 26, 2011) [UTMB 299UTMB 301], Exhibit 6.66.
687
Id. at [UTMB 299].
688
Id. at [UTMB 300].
689
Id.
685

267

paid by [UTMB Researcher #2] upon receipt of certificates of training by Planned Parenthood
Staff.690
The contract would have required [UTMB Researcher #2] to provide all supplies
necessary to conduct this study at Planned Parenthood. Supplies may be purchased by Planned
Parenthood with the approval of the Director of Research and reimbursed by [UTMB Researcher
#2] on a pass-through basis by [UTMB Researcher #2].691 The Panel notes that, had the July
2011 contract been executed as drafted, PPGC would have received $75,000 solely for the
consent of patients.
10. PPGCs Relationship with Baylor College of Medicine
From November 1, 2013, through November 4, 2015, PPGC entered into negotiations to
procure fetal tissue for BCM. On November 1, 2013, [PPGC Abortion Doctor] of PPGC sent an
email to [BCM Researcher], a copy of which was sent to [PPGC Executive] and [PP Witness
#2]. [PPGC Abortion Doctor] putting [BCM Researcher] in touch with [PP Executive] who
oversees all research, as well as [PP Witness #2] who will be your primary contact person
during the IRB approval/coordination phase.692
BCM personnel coordinated closely with the clinic, looking to [PP Witness #2] for
direction. On March 24, 2014, [BCM Researcher] sent an email to [PP Witness #2]:
Thank you for speaking with me today, and for your help with the
IRB. Attached, please find my original submission. the consent form
draft, and the response from the IRB. . . . Please feel free to contact
me any time with any questions you may have[.]693
On repeated occasions, including email correspondence on May 20 and June 3, 2014, [BCM
Researcher] asked [PP Witness #2] for additional assistance by commenting on questions raised
by BCMs IRB.694
Other emails evidence the close communication [BCM Researcher]s staff had with [PP
Witness #2]. In an October 20, 2014, email, [BCM Staff] thanked [PP Witness #2] for the
productive phone call. She continued, I spoke with [BCM Researcher] after our phone call
ended and she was really excited to know we had made so much progress. I have outlined some
of her comments/feedback below . . . .695

690

Id.
Id. at [UTMB 301].
692
Email from [PPGC Abortion Doctor] to [BCM Researcher] (Nov. 1, 2013), Exhibit 6.67.
693
Email from [BCM Researcher] to [PP Witness #2] (Mar. 24, 2014), Exhibit 6.68.
694
Email from [BCM Researcher] to [PP Witness #2] (May 20, 2014), Exhibit 6.69; Email from [BCM Researcher]
to [PP Witness #2] (May 20, 2014), Exhibit 6.70.
695
Email from [BCM Staff] to [PP Witness #2] (Oct. 20, 2014), Exhibit 6.71.
691

268

BCM produced to the Panel copies of a draft contract with PPGC for the procurement of
fetal tissue that were never executed to the Panel.696 The contract terms were similar to those
proposed to UTMB: Under the proposed contract, BCM would have been required to pay PPGC
$150 per executed informed consent, which included $50 for staff time expense involved in
obtaining consent and relevant study documentation and $100 per-informed consent for sterile
procedure room set-up and sample collection.697 Under the contract, PPGC will consent up to
500 patients.698 The contract also called for BCM to reimburse PPGC annual administrative fees
of $2,000 for Surgical Services and Research Management oversight, consent storage, and
supply storage. This list is not all inclusive.699
On November 17, 2014, [BCM Staff] sent [PP Witness #2] an email, the subject of which
was Pediatrics Research Proposal BCM Researcher/Baylor College of Medicine IRB
Approval Obtained, that stated: I would like to thank you for your support through our IRB
review process. . . . Our IRB proposal for your outlining the study procedures/objectives is also
attached for your reference.700 [PP Witness #2] replied, Thank you!701 Multiple email
exchanges between [PP Witness #2] and BCM employees show that PPGC knew the BCM IRB
had approved the proposal. For example: On June 22, 2015, [BCM Contract Manager] sent an
email to [PP Witness #2] to follow up on the status of the review for the MTA [Material
Transfer Agreement] for [BCM Researcher] of Baylor College of Medicine.702 On July 7, [PP
Witness #2] replied suggesting modifications to the MTA, adding that a contract specialist from
BCM should edit it.703
On July 14, 2015, CMP began its release of videotapes obtained during the course of its
30-month long investigation into the sale of fetal tissue by PPFA affiliates to tissue procurement
companies.704 The release of the videos prompted several congressional investigations, and led to
the Panels creation by the U.S. House of Representatives. The timing behind the start of CMPs
release of its videotapes is relevant in light of how PPGC ended its negotiations with BCM.
On October 13, 2015, [BCM Researcher #2] sent [PP Witness #2] an email in which she
stated:
. . . I hope you are well and had a great weekend.
In light of recent events, do we need to make a change to our
contract?

696

Tissue Supply and Biological Specimen Agreement between PPGC and BCM, Exhibit 6.72.
Id. at 2(b)(i).
698
Id. at 2(b)(i).
699
Id. at 2(b)(iii).
700
Email from [BCM Staff] to [PP Witness #2] (Nov. 17, 2014, 10:31 AM), Exhibit 6.73.
701
Email from [PP Witness #2] to [BCM Staff] (Nov. 17, 2014, 12:01 PM), Exhibit 6.73.
702
Email from [BCM Contract Manager] to [PP Witness #2] (June 22, 2015), Exhibit 6.74.
703
Email from [PP Witness #2] to [BCM Contract Manager] (July 7, 2015), Exhibit 6.74.
704
See Center for Medical Progress website, http://www.centerformedicalprogress.org/human-capital/.
697

269

I still very much believe in the value of my NIH funded studies, and
would very much like to proceed if that is possible.705
[PP Witness #2] responded in a November 4, 2015, email in which [PP Witness #2]
stated that PPGC will not commit to engage in any fetal tissue research endeavors at this time.
[PP Witness #2] continued, Academic institutions in Texas cannot remain publicly silent
regarding their need for donated fetal tissue in research, yet have expectations that research
collaboration with Planned Parenthood will remain intact.706
11. Potential Violations of Law
b) Applicable Laws
i) 42 U.S.C. 289g-2
The applicable federal law on fetal tissue is 289g-2, which is discussed above.707
ii) Texas Penal Code 48.02
The Texas Penal Code makes it a misdemeanor if anyone knowingly or intentionally
offers to buy, offers to sell, acquires, receives, sells, or otherwise transfers any human organ for
valuable consideration.708 Under the statute, valuable consideration does not include a fee
paid to a physician or to other medical personnel for services rendered in the usual course of
medical practice or a fee paid for hospital or other clinical services, reimbursement of legal or
medical expenses incurred for the benefit of the ultimate receiver of the organ; or
reimbursement of expenses of travel, housing, and lost wages incurred by the donor of a human
organ in connection with the donation of the organ.709
The statute defines a human organ as the human kidney, liver, heart, lung, pancreas, eye,
bone, skin, fetal tissue, or any other human organ or tissue, but does not include hair or blood,
blood components (including plasma), blood derivatives, or blood reagents.710
iii) Texas Penal Code 37.08
Another provision of the Texas Penal Code makes it a misdemeanor for a person to lie to
a law enforcement officer. The law states:
A person commits an offense if, with intent to deceive, he
knowingly makes a false statement that is material to a criminal
investigation and makes the statement to: . . . a peace officer or
705

Email from [BCM Researcher] to [PP Witness #2] (Oct. 13, 2015), Exhibit 6.75.
Email from [PP Witness #2] to [BCM Staff] (Nov. 4, 2015), Exhibit 6.76.
707
See Chapters I.C, II.B.3 supra.
708
Tex. Penal Code 48.02(b).
709
Tex. Penal Code 48.02(c).
710
Tex. Penal Code 48.02(a).
706

270

federal special investigator conducting the investigation; or . . . any

employee of a law enforcement agency that is authorized by the
agency to conduct the investigation and that the actor knows is
conducting the investigation.711
12. Findings
c) 42 U.S.C. 289g-2 and Texas Penal Code 48.02
The Panels investigation raises questions of whether PPGC may have violated 289g-2
and Texas Penal Code 48.02. PPGC was paid for consent from patients. Consent is not a cost
for which an entity can be reimbursed under 289g-2. It is valuable consideration.
Documents produced to the Panel by UTMB show that PPGC also transferred fetal tissue
to UTMB in exchange for valuable consideration as defined by the Texas Penal Code.
Documents produced to the Panel by BCM show that PPGC knowingly offered to sell or transfer
fetal tissue to BCM.
d) Texas Penal Code 37.08
On October 22, 2015, nearly a year after PPGC learned that BCMs IRB had given its
approval712 and [PP Witness #2] sent her email to [BCM Researcher] in which she stated that
PPGC would not commit to engage in any fetal tissue research endeavors at this time,713
representatives of the Texas Department of Public Safety Texas Ranger Division, the House
Police Department homicide division, and the Harris County district attorneys office visited
PPGC headquarters to investigate allegations that PPGC may have violated Tex. Penal Code
48.02.714 (The report refers to PPGC as GCPP.)
During the course of this visit, PPGCs attorney introduced the law enforcement
representatives to [PP Witness #2], who the attorney described as being a Long time Baylor
employee who had been instrumental in building the current research program.715 The Texas
Department of Public Safety Texas Ranger Division report stated that:
[PPGCs attorney] advised that the last collected fetal tissue
specimen collected by GCPP for a scientific study was on 07-262011, for the University of Texas Medical Branch. GCPP was
recently approached by the Baylor College of Medicine and Rice

711

Tex. Penal Code Title 8, 37.08.

Email correspondence between [BCM Staff] & [PP Witness #2] (Nov. 17, 2014), Exhibit 6.73; Email
correspondence between [BCM Contract Manager] & [PP Witness #2] (June 22 & July 7, 2015), Exhibit 6.74;
Email from [BCM Researcher] to [PP Witness #2] (Oct. 13, 2015), Exhibit 6.75; Email from [PP Witness #2] to
[BCM Staff] (Nov. 4, 2015), Exhibit 6.76.
713
Email from [PP Witness #2] to [BCM Staff] (Nov. 4, 2015), Exhibit 6.76.
714
Tex. Dept. of Pub. Safety Tex. Ranger Div., Report of Investigation Exhibit 6.77.
715
Id.
712

271

University for fetal tissue studies. The Institutional Review Board

had not yet given approval for the Baylor or Rice studies.716
[PP Witness #2] and potentially other PPGC officials knew that BCMs IRB had
approved the research project, despite representations of PPGCs attorney to Texas law
enforcement officials that no IRB approval had been obtained by BCM.
C. The University of Minnesota
The practices of the University of Minnesota (UM) with respect to fetal tissue research
and disposal were the subject of media and legislative inquiry that came to evoke skepticism of
its institutional candor. Amid the heightened attention to questions surrounding fetal tissue
trafficking in 2015, UM spokespeople initially denied to journalists and state legislators that fetal
tissue research occurred on campus, but after a news outlet uncovered receipts of fetal tissue
purchases, the university reversed course and admitted that such research had taken place.717
Following a request it made under Minnesotas Open Records Law, the news outlet apparently
had triggered the correction after it discovered that UM made payments for fetal tissue since
between 2008 and 2014 from both tissue procurement companies and abortion clinics.718
After it was formed, the Panel followed with a request to UM dated January 21, 2016, for
relevant documents dating back to 2010. UM responded with a production on February 29 that
confirmed they had in fact procured fetal tissue from two procurement companiesAdvanced
Bioscience Resources (ABR) and StemExpressthe National Disease Research Interchange, and
an abortion clinic, the Meadowbrook Womens Clinic of Minneapolis, which operates today
under the banner of the Texas-based Whole Womans Health Clinic.719 This list may well be
incomplete: UMs produced correspondence includes references to tissue orders from the
university to Coriell Cell Repositories and the biotech company Regenx.720 UM did identify
ABR as its primary supplier of fetal tissue. Additionally, in stark contrast to its earlier denials of
any fetal tissue research activity, UM disclosed that approximately 10 researchers at the
University of Minnesota have used such tissue currently or in the recent past and that UM
was the recipient of well over $1 million in NIH grants for projects that used fetal tissue.721
To the Panels request for all accounting records related to the cost and pricing of fetal
tissue, UM produced only invoices from ABR, which showed charges ranging from $275 to
$2,675 that reflected ABRs varying fee schedule for different types of fetal tissue.722 Thus, its
716

Id.
See Letter from Marion ONeill, Vice-Chair, House Higher Education Policy and Finance Committee, to
University of Minnesota Board of Regents, at 1 (Oct. 22, 2015), Exhibit 6.78; Jeremy Olson, After Awkward FlipFlop, U Toughens Its Policies and Defends Practices, Star Tribune, Jan. 31, 2016, at 1A; Youssef Rddad, U Revisits
Fetal Tissue Practices, Minnesota Daily, Feb. 3, 2016, at 1.
718
See id.
719
UM letter responding to document request, at 1 (Feb. 29, 2016), Exhibit 6.79.
720
UM production, Attachment A excerpts (Coriell & Regenx references), Exhibit 6.80.
721
UM production, Attachment C, Exhibit 6.81.
722
UM production, Attachment A excerpts (copies of ABR fees for services schedule), Exhibit 6.82; Attachment B
(invoices), Exhibit 6.83.
717

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practices with respect to fetal tissue raise questions of liability under 289g-2 that have been
examined in the above analysis of ABR and StemExpress.723 Moreover, the monetary range of its
tissue orders is apparently not reflected in the produced ABR invoices: the above referenced
correspondence notes $3,555 of charges incurred by a UM lab manager on September 9, 2014,
for tissue from Regenx.724 UM did not disclose its payment practices or other exchanged value
with respect to the area abortion clinic, a matter that merits further inquiry.
Independent of the question of what payments or other value exchanged implicate federal
law, UMs underlying fetal tissue practices potentially violate several provisions of state law.
Minnesotas Anatomical Gift Act permits the donation of fetal tissue only if it is a stillborn
infant or an embryo or fetus that has died of natural causes in utero.725 Minnesota law also
establishes as a gross misdemeanor the use of a living human conceptus for any type of
scientific, laboratory research or other experimentation except to protect the life or health of the
conceptus, or except for research verifiable scientific evidence has shown to be harmless to the
conceptus.726 The state also requires fetal remains, whether resulting from an abortion or
miscarriage, to be disposed of by cremation, interment by burial, or in a manner directed by
the commissioner of health.727
UM apparently violated these laws by conducting research on aborted fetuses and
additionally by disposing of fetal remains as biohazard waste. Following public disclosure of its
practices, the university continues to procure fetal tissue, but it changed its policy to require such
tissue to come from sources outside Minnesota and to provide for its disposal in the same way as
donated human cadavers.728 The institutions decision to cross state lines to procure fetal tissue
appears to be an effort to avoid criminal liability under Minnesota law. This should prompt
Congress to pass legislation that would prohibit the crossing of state lines to evade such basic
protections of human dignity at the most vulnerable stages of life.
D. Colorado State University
Colorado State University (CSU) entered a contract with Planned Parenthood of the
Rocky Mountains (PPRM) in March 2010.729 Under the Agreement for Transfer of Human
Fetal Tissue between PPRM and CSU, university personnel were permitted to collect tissue at
the Planned Parenthood clinic. Planned Parenthood personnel were tasked with obtaining
informed consent from patients, and the agreement specified that the university would
reimburse Planned Parenthood for reasonable expenses incurred during the tissue retrieval
process such [as] the time involved in obtaining consent and packaging donations.730

723

See Chapter V supra.

UM production, Attachment A excerpts (Regenx reference), Exhibit 6.80.
725
Minn. Stat. 525A.02 subdiv. 5.
726
Minn. Stat. 145.422 subdiv. 1 & 2.
727
Minn. Stat. 145.1621 subdiv. 3 & 4.
728
See Jeremy Olson, After Awkward Flip-Flop, U Toughens Its Policies and Defends Practices, Star Tribune, Jan.
31, 2016, at 1A; Youssef Rddad, U Revisits Fetal Tissue Practices, Minnesota Daily, Feb. 3, 2016, at 1.
729
See CSU and Planned Parenthood of the Rocky Mountains MTA, Exhibit 6.84.
730
Id.
724

273

One invoice dated April 27, 2010, included a $1,500 charge to the university for
Administrative Start Up. Another invoice charged $1,600 for consent and processing for 10
specimens. These charges merit investigation given that, under their agreement, CSU provided
the packaging materials, and it is not apparent that there were any associated shipping costs. 731
After public exposure of CSUs relationship with Planned Parenthood, a subsequent
lawsuit against CSU claiming that CSUs contractual relationship with Planned Parenthood
violated the state constitution,732 and Congress inquiry into the fetal tissue research industry,
CSU halted acquisition of fetal tissue from any vendors implicated in the investigation.733
Like UM, CSU receives a significant amount in federal grants and obtains much of its
fetal tissue from ABR and StemExpress. Between 2010 and 2015, CSU received seven NIH
grants to support their projects using fetal tissue, at a taxpayer expense of $3.5 million.734 During
that same period, according to documents it produced to the Panel and in litigation, CSU paid
ABR nearly $100,000735 and paid StemExpress over $2,000 for fetal tissue.736 As with UM,
CSUs practices with respect to fetal tissue raise the same questions of liability under 289g-2
that arise in the cases of ABR and StemExpress.
E. University of California at San Francisco
The University of California San Francisco (UCSF) has been characterized as the hub of
the abortion-rights countermovement in medicine.737 The Fellowship in Family Planning began
at the Bixby Center for Global Reproductive Health at UCSFa two-year program following
residency that pays doctors to sharpen their skills in abortion and contraception, to venture into
research and to do international work.738 The program spread to around 30 other universities and
presently has 246 graduated fellows.739
The Ryan Residency Training Program in Abortion and Contraception also began at the
Bixby Center for Global Reproductive Health at UCSF in 1999. The Ryan Program provide[s]
resources and technical expertise to departments of obstetrics and gynecology to establish a
formal, opt-out rotation in family planning, either by establishing or expanding an outpatient
family planning service within the academic medical center or by linking institutions with a
731

See CSU documents [CSU000002, CSU000019-CSU000022], Exhibit 6.85.

See First Amended Complaint, McIntire v. Board of Governors of the Colorado State University System d/b/a
Colorado State University, No. 2015CV30865 (Dis. Ct. Larimer County Oct. 7, 2015) (McIntyre Am. Compl.).
733
Rob White, CSU halts some fetal tissue acquisition, Coloradoan, July 28, 2015,
http://www.coloradoan.com/story/news/2015/07/28/colorado-state-university-stem-express/30809431/.
734
See NIH Research Portfolio Online Reporting Tools, https://projectreporter.nih.gov/reporter_searchresults.cfm.
735
See McIntyre Am. Compl. at 42 & Ex. 4 (summarizing ABR invoices). This is consistent with documents CSU
produced to the Panel.
736
StemExpress documents, Exhibit 6.86.
737
Emily Bazelon, The New Abortion Providers, N. Y. Times Mag., July 18, 2010, at MM30,
http://www.nytimes.com/2010/07/18/magazine/18abortion-t.html?pagewanted=all&_r=0.
738
Id.
739
See Fellowship in Family Planning, Where are the Fellowships located?,
http://www.familyplanningfellowship.org/fellowship-programs, Exhibit 6.46; Fellowship in Family Planning,
Application information, http://www.familyplanningfellowship.org/application-information.
732

274

freestanding clinic, such as Planned Parenthood.740 There are over 80 Ryan Program sites in the
U.S. and Canada.741
Both the Fellowship in Family Planning and the Ryan Residency Training Program are
funded by the Susan Thompson Buffett Foundation, which is heavily financed by Warren
Buffett.742
UCSF is also involved in fetal tissue research. Between 2010 and 2015, UCSF received
nearly $17.5 million in taxpayer funding from the National Institutes of Health for research
projects using human fetal tissue.743
F. Washington University and Planned Parenthood of St. Louis
Planned Parenthood of the St. Louis Region and Southwest Missouri (PPSLR), reportedly
the only clinic in Missouri that provides abortions, became the subject of a state legislative
investigation in the wake of the revelations regarding Planned Parenthood in 2015. In one of the
undercover CMP videos, [PP Witness #1] made a statement suggesting that the clinic was
extensively involved in fetal tissue research when asked about tissue procurement opportunities:
[MO Doctor #1] is the Medical Director of the St. Louis region [of PP]. They do 2nd tris they
have a few extensive collaboration with all kinds of research, pretty dynamic medical director,
his name is [MO Doctor #1]. I think thats definitely worth your while. And just looking at the
map, if there was one place that was untapped, I would say St. Louis.744
On July 5, 2016, the Majority Caucus of the Missouri State Senate announced the initial
results of their investigation into PPSLR. According to its report, the Senate was hindered in its
investigation by months of stonewalling by Planned Parenthood executives and also by top
officials in Gov. Nixons Department of Health and Senior Services, as well as the refusal of
[MO Doctor #2], PPSLRs pathologist and the owner of Pathology Services, Inc., to testify,
invoking his Fifth Amendment privilege against self-incrimination. The Senate did obtain
enough information to assert that the clinic displayed a shocking callousness towards vulnerable
young women who seek their services and employed procedures that may very well constitute
outright medical malpractice. The report concluded, It appears that Planned Parenthood may
very well have violated both state statute and Department of Health regulations in their [fetal]
disposal practices.745

740

The Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, About the Ryan Program,
http://www.ryanprogram.org/node/1.
741
The Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, Map and locations,
http://www.ryanprogram.org/map-and-locations, Exhibit 6.46.
742
See Emily Bazelon, The New Abortion Providers, N. Y. Times Mag., July 18, 2010, at MM30,
http://www.nytimes.com/2010/07/18/magazine/18abortion-t.html?pagewanted=all&_r=0.
743
See NIH Research Portfolio Online Reporting Tools, https://projectreporter.nih.gov/reporter_searchresults.cfm.
744
Center for Medical Progress, Transcript of Videotape of Center for Medical Progress journalists and [PP Witness
#1] (July 25, 2014), at 19.
745
Missouri Senate Planned Parenthood Review Statement, at 1 (July 5, 2016),
http://www.senate.mo.gov/16web/wp-content/uploads/2016/07/Missouri-Senate-Planned-Parenthood-ReviewStatement.pdf.

275

The state senate investigation did not focus on the relationship between the clinic and
Washington University of St. Louis, but the Majority Caucus findings are relevant to analysis of
that relationship. PPSLRs medical director, [MO Doctor #1], and four other physicians known
to work at PPSLR have positions at the Ob/Gyn department of the Washington University
School of Medicine:

[MO Doctor #1] is an assistant professor.

[MO Doctor #3] is an instructor.
[MO Doctor #4] is a professor.
[MO Doctor #5] is an associate professor in the division of family planning.
[MO Doctor #6] is or was a clinical fellow.

Moreover, Washington Universitys medical school offers the Ryan Fellowship, by which
university fellows are deployed to perform abortions at PPSLR.746 The university has been
acknowledged as a recipient of fetal tissue from UW, but the details of those acquisitions are
unclear from UWs extensive redactions. That question merits further investigation, as do the
questions of whether PPSLR supplies Washington University fetal tissue and, if so, whether
monetary payments or other value is exchanged among the entities shared personnel.
G. University of Wisconsin
The University of Wisconsin, School of Medicine and Public Health (UW SMPH)
provides another example of a close relationship between a public research institution and
Planned Parenthoodin this case, Planned Parenthood of Wisconsin (PPWI). The two entities
have maintained a relationship in which UW SMPH would deploy faculty members of its
Ob/Gyn department to work at a clinic designated by PPWI while still being paid by UW SMPH.
The relationship was outlined in a memorandum of understanding obtained by the Panel and
signed in 2008. It provided among other things that [WI Doctor #1], an assistant professor of
Ob/Gyn at UW SMPH, would serve as the clinics associate medical director.747 The move was
apparently part of a broader plan that included the procurement and transfer of fetal tissue for
research, and UW SMPH admitted in response to a January 21, 2016, document request from the
Panel that at the time, it obtained fetal tissue from PPWI.748 [WI Doctor #1] was central to plans
to provide late-term, second-trimester abortions in Madison, Wisconsin. When she departed
Wisconsin for Harvard in 2010, a UW SMPH spokesperson made clear that this was a change
in who provides the service, but otherwise there is no change in our plans.749 Both [WI Doctor
#1] and another UW SMPH faculty member who also worked at PPWI, [WI Doctor #2], were
746

Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, Map and locations,
http://www.ryanprogram.org/map-and-locations, Exhibit 6.46. The deployment of fellows to PPSLR was confirmed
by a confidential witness and the following article: Abigail Golden, The Medical Communitys Hidden AbortionTraining War, Daily Beast, Feb. 27, 2014, http://www.thedailybeast.com/articles/2014/02/27/the-medicalcommunity-s-hidden-abortion-training-war.html.
747
Memorandum of Understanding between the University of Wisconsin Madison and Planned Parenthood of
Wisconsin, Inc. (Dec. 2008), Exhibit 6.87.
748
Letter from UW SMPH to House Select Investigative Panel 3 (Feb. 15, 2016), Exhibit 6.88.
749
Ryan J. Foley, Doctor Key to UW Abortion Plan Leaving for Harvard, Associated Press (June 14, 2010).

276

acknowledged for their support with tissue collection and processing in a 2014 article that had
relied on the collection of 10 fetal brains at gestational ages of 10 to 18 weeks.750
[WI Doctor #2] remains active on both UW SMPHs Ob/Gyn faculty and PPWI, and she
serves as director of the Ryan Fellowship at UW SMPH. The University of Wisconsin deploys
residents to PPWI and memorializes this program in a separate contract between the University
of Wisconsin Hospitals and Clinics Authority (UWHC) and PPWI.751 As under the faculty
contract, residents who participate in this program would be paid not by the clinic, but by the
university via UWHC. Additionally, the contract provided that while at PPWI, residents would
be supervised by physicians who have UWSMPH faculty appointments and are members of the
medical staff at PPWI, or, at the specific direction of the Director of Medical Education at
PPWI, a position the contract also provided would be held by a UW SMPH doctor, by
other[]licensed PPWI physicians.752
While UW SMPHs relationship with PPWI continues, the school maintains that it has
not obtained fetal tissue from that clinic network since November 2010. UW SMPH identifies
the Albert Einstein College of Medicine, the University of Washington, and ABR as its sources
of fetal tissue since 2010.753 The vast majority of invoices it produced to the Panel come from
ABR, dated between 2010 to 2015, and those range in amount from $310 to $2,200.754 This is
pursuant to ABRs high, tissue-specific fees for services schedule.755 This range differs
considerably from UW SMPHs charges from the University of Washington, which average
under $300.756 The transactions illustrate the problematical nature of ABRs practices under
289g-2, which were examined above.757 This is clearly material to any analysis of compliance by
universities like UW SMPH.
H. University of Michigan
The University of Michigan (UMich) is a public research institution that conducts
research using fetal tissue obtained from tissue procurement businesses and universities, though
mostly from the former. In response to a January 21, 2016, document request from the Panel to
the UMich Medical School, the university acknowledged eight research studies that utilized fetal
tissue since 2010. Five researchers from different departments of UMichpsychiatry, urology,
human genetics, environmental health sciences, and internal medicineeach procured fetal
tissue for a separate research study.758 Three more studies came from researchers in the
750

Prenatal Diagnosis 2014, 34, 431-437. Doi: 10.1002/pd.4322. Differential Changes in Gene Expression in
Human Brain During Late First Trimester and Early Second Trimester of Pregnancy.
751
Agreement for the Affiliation of Planned Parenthood of Wisconsin, Inc., with University of Wisconsin Hospitals
and Clinics Authority for the Training of Residents (Apr. 14, 2009), Exhibit 6.89.
752
Id. at 2.
753
Letter from UW SMPH to House Select Investigative Panel 3 (Feb. 15, 2016), Exhibit 6.88.
754
UW SMPH production [00052, 00069 (invoices for $310)] & [00012 (invoice for $2,200)], Exhibit 6.88.
755
UW SMPH production [00002-00003], Exhibit 6.88.
756
See UW SMPH production [00017-00018, 00027-00028, 00029-00030 (three charges of $200)] & [00023-00024,
00025-00026 (two charges of $400)], Exhibit 6.88.
757
See Chapter V.D supra.
758
Letter from UMich to House Select Investigative Panel 2-3 (Feb. 29, 2016), Exhibit 6.90.

277

department of ophthalmology.759 ABR supplied the fetal tissue used in all three ophalmology
studies and the internal medicine studies. Novogenix supplied tissue to internal medicine and
human genetics. UW supplied tissue to the departments of urology and environmental health
sciences, and the psychiatry department researcher obtained tissue from the UMich Health
System.760
Physicians from UMichs Health System staff a Planned Parenthood clinic in Ann Arbor,
Michigan, and medical students are eligible to provide abortions there through the Ryan
Fellowship, in which UMich is a participant.761 The Planned Parenthood clinic is even listed in
the our locations section of the UMich Health System website.762 Among the shared staff
between UMich and Planned Parenthood, statements captured on undercover video by [MI
Doctor] are of particular concern. [MI Doctor], who is both an associate professor in UMichs
Ob/Gyn department and medical director for Planned Parenthood, told the following to a Center
for Medical Progress journalist regarding her prospective involvement in the acquisition of fetal
tissue for research:
If Im involved, it would have to go through my University of
Michigan IRB, and they tend to be pretty easy about stuff and
actually not require informed consent because that would be the
biggest breach of confidentiality and of tissue discarded anyway,
their feeling is you dont even need to consent people. Which is
interesting. Planned Parenthood, on the other hand, does feel like
you need to sign [unintelligible].763
This admission obviously raises serious questions about UMichs compliance with IRB and
informed consent requirements.
In another part of their conversation, when [MI Doctor] was asked whether her past work
in this area was with a dedicated procurement organization, she replied, No, it was with
individual researchers who needed either decidual tissue or fetal, they were trfetal orbits, or,
you know, specific, short-term research projects. While she had never encountered a perspecimen fee in such arrangements, she added that all research projects . . . pay for the effort. .
. . theyve had sort of like grants to the agency to cover my time.764 This statement is
problematical because, if in fact she were paid for her time procuring fetal tissue, there arises the
759

Id.
Id.
761
See Michigan Outreach, Family Medicine Medical Consulting (Planned Parenthood),
http://outreach.umich.edu/programs/family-medicine-medical-consulting-planned-parenthood/, Exhibit 6.91; The
Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, Map and locations,
http://www.ryanprogram.org/map-and-locations, Exhibit 6.46.
762
Ann Arbor Planned Parenthood, http://www.uofmhealth.org/our-locations/ann-arbor-planned-parenthood, Exhibit
6.92.
763
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNNF0991_20140408112137 (065000).
764
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNNF0991_20140408115753 (009300-011300).
760

278

question of whether the grants she refers to cover more than statutorily permissible
reimbursements for costs under 289g-2. As for UMich institutionally, its use of ABR and
Novogenix, both of which companies the Panel has discovered did charge per specimen,
suggests the need for further inquiry into its fetal tissue acquisition practices.

279

VII. Case Studies of Late-Term Abortion Clinics

Chapter VII Redaction Key:
1. Abortion Doctor #1 is an abortion provider in Nebraska and Maryland.
2. Abortion Doctor #2 is an abortion provider in Colorado.
3. Abortion Doctor #3 is an abortion provider in Texas.
4. Dr. Administrator is a faculty member at the University of New Mexico.
5. Clinic A Dr. #1 is an employee of Southwestern Womens Options and a faculty
member of the University of New Mexico.
6. Clinic B Staff #1 is an employee of a late-term abortion clinic in Maryland for
[Abortion Doctor #1].
7. Clinic B Staff #2 is an employee of a late-term abortion clinic in Maryland for
[Abortion Doctor #1].
8. Clinic B Staff #3 is an employee of a late-term abortion clinic in Maryland for
[Abortion Doctor #1].
9. Clinic B Staff #4 is an employee of a late-term abortion clinic in Maryland for
[Abortion Doctor #1].
10. Employee #1 is an employee of a late-term abortion clinic in Texas for [Abortion
Doctor #3].
11. Employee #2 is an employee of a late-term abortion clinic in Texas for [Abortion
Doctor #3].
12. Employee #3 is an employee of a late-term abortion clinic in Texas for [Abortion
Doctor #3].
13. Employee #4 is an employee of a late-term abortion clinic in Texas for [Abortion
Doctor #3].
14. Patient #1 is a former patient of [Abortion Doctor #3].

280

A. Summary
Abortion clinics and hospitals typically use one of two methods when performing
abortions in the second and third trimesters of pregnancydilatation and evacuation (D&E) or
induction. Both of these procedures require a patients cervix to be dilated over a period of hours
to days prior to the actual procedure. During that dilation process, an infant can be delivered
spontaneously.765 If the infant has not been administered feticidetypically intracardiac
potassium chloride injection (KCl) or intrafetal/intra-amniotic digoxin injection766 or if the
feticide fails, infants are sometimes born alive.767 While infants are not likely to be born alive
during the D&E procedure, which entails dismembering and removing the infant and the
placenta with forceps, infants have been born alive following the induction process in an
induction abortion.768
The business practices and procedures of late-term clinics implicate numerous legal and
ethical concerns. When human infants are born alive in late-term abortion clinics or hospitals,
abortion providers are obligated to ensure that these infants are afforded all of the protections
guaranteed by federal and state law. However, pressure from research institutions or procurement
companies to provide human fetal organs and tissue at late gestations could negatively impact the
treatment born-alive infants receive. Infants with congenital health problems are particularly
vulnerable to neglect or abuse.
According to the Centers for Disease Control, between 2003 and 2014, 588 reported
infant deaths included a code indicating that a cause of death was termination of pregnancy,
affecting fetus and newborn. At least 143 of these deaths could definitively be classified as
involving an induced abortion; however, the CDC acknowledges that this could be an
underestimate.769
A careful investigation of late-term abortion providers is necessary to ensure that entities
are complying with the federal Born-Alive Infants Protection Act,770 42 U.S.C. 289g, et seq.,
federal regulations pertaining to human fetal tissue research, and state laws, including anatomical
gift laws.
The significance of this inquiry includes the issue of the taxpayers indirect support of
late-term abortion. In fact, most of the doctors west of the Mississippi who openly perform thirdtrimester abortions have faculty positions at either the University of New Mexico or the
See SFP Clinical Guidelines: Cervical preparation for second-trimester surgical abortion prior to 20 weeks
gestation, Contraception 89 (2014) 75-84, http://www.contraceptionjournal.org/article/S0010-7824(13)00686-0/pdf.
766
See SFP Clinical Guidelines: Induction of fetal demise before abortion, Contraception 81 (2010) 462-473,
http://www.contraceptionjournal.org/article/S0010-7824(10)00019-3/pdf.
767
See SFP Clinical Guidelines: Labor induction abortion in the second trimester, Contraception 84 (2011) 4-18,
http://www.contraceptionjournal.org/article/S0010-7824(11)00057-6/pdf.
768
Id.
769
Centers for Disease Control and Prevention, Mortality Records with Mention of International Classification of
Diseases-10 code P96.4 (Termination of Pregnancy): United States, 2003-2014,
http://www.cdc.gov/nchs/health_policy/mortality-records-mentioning-termination-of-pregnancy.htm.
770
1 U.S.C. 8.
765

281

University of Colorado. The broad public disapproval of such practices raises the question of
why institutions that receive public funds should carry the tacit imprimatur imparted by
institutional affiliation.
The Panel investigated several abortion providers and clinics around the country:
[Abortion Doctor #1], [Abortion Doctor #2], [Abortion Doctor #3], University of New Mexico,
and Southwestern Womens Options.
B. [Abortion Doctor #1]
1. Background on [Abortion Doctor #1]
[Abortion Doctor #1], M.D., performs abortions at two clinicsone in Nebraska, which
he owns, and one in Maryland. [Abortion Doctor #1] began doing abortions full-time in 1988 in
Nebraska.771 [Abortion Doctor #1] has been very open about being an abortionist. He challenged
the Partial-Birth Abortion Ban Act and lost before the United States Supreme Court in 2005. On
his website, he shares that the Washington Post, Huffington Post, the New York Times, Ms.
Magazine, and Newsweek have all featured him in their publications. Also, he was one of the
late-term abortion doctors featured in the film After Tiller.772
In his Nebraska clinic, he offered late-term abortions, having worked with George Tiller
for over 10 years, until Nebraska outlawed abortions after 20 weeks.773 Because he could no
longer provide abortions after 20 weeks in Nebraska, he began performing late-term abortions in
a clinic in Maryland, thus splitting his week between the two clinics.
2. The Panel Issues a Subpoena to [Abortion Doctor #1]
On May 15, 2016, the Panel sent [Abortion Doctor #1] a subpoena, inquiring into
whether his abortion clinics, specifically the clinic in Maryland, have participated in fetal tissue
donation, what abortion procedures are conducted in the clinics, and the clinics protocols in the
event an infant is born alive following an abortion procedure.
[Abortion Doctor #1] partially complied with the subpoena by producing information
from his clinic in Nebraska. He stated that he has not donated any fetal tissue at the clinic in
Nebraska.774 However, he did not produce any information for the Maryland clinic, claiming he
did not have the authority to do so since he is not an agent of the facility.775

771

About [Abortion Doctor #1], http://www.abortionclinics.org.

Id.
773
Id.
774
Letter from Pillsbury Winthrop Shaw Pittman LLP, to Rep. Marsha Blackburn, Chairman, House Select
Investigative Panel 3 (May 23, 2016), Exhibit 7.1.
775
Id. at 4.
772

282

3. The Panels Investigation into the Clinic in Maryland

Therefore, the Panel decided to interview several of the employees of the clinic in
Maryland in order to investigate the above-mentioned items. In the interviews, when questioned
on when [Abortion Doctor #1] thinks viability occurs, the employees stated 27 weeks. 776 [Clinic
Worker #1] stated that up to 27 weeks, the woman does not need to provide a justification for the
abortion, as shown in the following excerpt from the transcript:
Q Can I just, the 20- to 27-week range, which is about
50 percent of your practice, so do the women have to provide any
justification for the abortion during that period of time from 20 to
27 weeks?
A No, maam.
Q So it's only after 27 weeks?
A Correct.777
In a video filmed undercover by the Center for Medical Progress (CMP) at the National
Abortion Federation (NAF) conference, [Clinic Worker #1] said that they do not do many
abortions before 18 weeks. She said, Were one of the big three. We do up to 35 weeks.778
According to an affidavit written by a confidential informant who has been a sidewalk counselor
(i.e., an individual who prays outside the clinic and tries to dissuade women from having
abortions) outside the clinic for 5 years, many of the 3rd-trimester abortions are elective.779 She
goes on to say that since [Abortion Doctor #1] has been working in Maryland, we have
recorded over 40 such post-viability abortions being done for trivial reasons having nothing to do
with the health or life of either mother or baby.780
In addition to the concerns that purely elective, post-viability abortions are taking place,
there have been several medical complications that have occurred at the clinic, under the watch
of [Abortion Doctor #1]. Since December 2010, 9 women have been transferred to a nearby
hospital due to complications from an abortion at this clinic, with 7 of them being emergency
transports.781 The most alarming factor is that 5 of the 9 transfers have occurred since December
2015. In April 2016, the Panel met with a confidential informant, a former employee of the
clinic, who claimed that [Abortion Doctor #1] is not fit to practice due to arthritis in his hands.

776

Transcribed interview of [Clinic Workers #1, #2, #3, and #4] (July 21, 2106) at 37, 139.
Id. at 38.
778
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNPB0298_20150419143440.
779
Affidavit of [Confidential Informant], Dec. 3, 2016 ([Confidential Informant] Aff.), 3, Exhibit 7.2.
780
[Confidential Informant] Aff., 4, Exhibit 7.2.
781
Transcribed interview of [Clinic Workers #1, #2, #3, and #4] (July 21, 2106) at 32.
777

283

Recently, [Abortion Doctor #1] did not practice at the Maryland clinic for 8 weeks.
Rumor spread that he had stopped his practice in Maryland. However, he returned to the clinic
on December 11, 2016, and resumed providing abortions.782
C. [Abortion Doctor #2]
1. Background on [Abortion Doctor #2]
[Abortion Doctor #2], M.D., M.P.H., Ph.D., owner of the Boulder Abortion Clinic, has
been an abortionist since 1973.783 He wrote Abortion Practice, a medical textbook on abortion.784
He also was featured in the movie After Tiller, in which he spoke openly about his practice.
In 2003, [Abortion Doctor #2] wrote a paper titled Has the Human Species Become a
Cancer on the Planet?: A Theoretical View of Population Growth as a Sign of Pathology. In the
paper, he discusses how population growth is one of the greatest problems we face today.785
Throughout the paper, he analogizes human population growth on the planet with cancer in the
bodyrapidly growing and damaging.786 He concludes with stating that the world must decide
to lower the number of births or it will occur because of ecological limitations and resource
degradation with the result of an increased number of deaths or declining fertility through social
disorganization (warfare).787 He states that the debates over abortion make the problem worse
because it limits options to couples who wish to decrease their fertility, and he praises the United
States decision to help countries around the world with their family planning programs.788
In 2003, after the passage of the Partial-Birth Abortion Ban Act, [Abortion Doctor #2]
wrote an article for Slate in which he states that the Partial-Birth Abortion Ban is ambiguous and
that his patients are afraid the law will prevent them from getting abortions in the future. He
finishes the article by describing an abortion he had recently done on a woman who was 17
weeks pregnant:
I ruptured the membranes and released the fluid to reduce the risk of
amniotic fluid embolism. Then I inserted my forceps into the uterus
and applied them to the head of the fetus, which was still alive, since
fetal injection is not done at that stage of pregnancy. I closed the
forceps, crushing the skull of the fetus, and withdrew the forceps.
The fetus, now dead, slid out more or less intact.789
782

The Return of [Abortion Doctor #1] to Germantown, Pray for Germantown (Dec. 11, 2016),
http://www.prayforgermantown.com.
783
About [Abortion Doctor #2], Boulder Abortion Clinic, P.C. (2010) http://www.drhern.com.
784
Id.
785
[Abortion Doctor #2], Has the Human Species Become a Cancer on the Planet?: A Theoretical View of
Population Growth as a Sign of Pathology, 36 Current World Leaders, 1089, at 1.
786
Id. at 17.
787
Id. at 18.
788
Id. at 18.
789
[Abortion Doctor #2], Did I Violate the Partial-Birth Abortion Ban?, Slate (Oct. 22, 2003)
http://www.slate.com/articles/health_and_science/medical_examiner/2003/10/did_i_violate_the_partialbirth_abortio
n_ban.html.

284

He finished the article by stating, Did I do a partial-birth abortion? Will John Ashcroft
prosecute me? Stay tuned.790
2. The Panels Investigation into [Abortion Doctor #2]
On November 2, 2016, the Panel sent [Abortion Doctor #2] a document request letter,
inquiring into whether his abortion clinic has participated in fetal tissue donation, what abortion
procedures are conducted in the clinic, and the clinic protocols for if an infant is born alive
following an abortion procedure. Shortly after the Panel sent the letter to [Abortion Doctor #2],
he bought a full-page ad in the Denver Post in which he published the letter from Chairman
Blackburn and his response to the letter. The Panel had not disclosed to the public that it had sent
a letter to [Abortion Doctor #2]. In his letter, he writes, [Y]our letter to me and letters to other
physicians constitute a program of target identification for anti-abortion assassins. . . .Your
investigation is legislative harassment that endangers our lives. The blood of any of us who are
assassinated is on your hands.791
[Abortion Doctor #2]s accusation carries no weight due to the fact that he himself made
it public that the Panel sent him a document request. The Panel kept this information
confidential. It did not issue a press release. The public would not have known about this letter if
[Abortion Doctor #2] had not told them through the publication of his letter in the Denver Post.
He then, after exposing his own name, asked the public for money to cover security costs for his
clinic through a fundraising website, an unnecessary measure if he had kept his involvement with
the investigation confidential, as the Panel had done for him.792 Furthermore, [Abortion Doctor
#2] has always been open and public about his abortion practice, through his clinics website, his
advertisements, his outspoken articles, and his participation as a star of the film After Tiller.
In [Abortion Doctor #2]s response to the Panel, he concludes by citing the Fifth
Amendment as his reason for not complying with the document request.
D. [Abortion Doctor #3]
1. Summary
Over the course of its investigation, the Panel collected statements and video from former
employees and a patient of [Abortion Doctor #3] who have alleged numerous violations of law at
one or more of his clinics, describing the practitioner as conducting himself with depraved
indifference to infant life and committing acts of murder. [Abortion Doctor #3] was previously
referred to the District Attorney of Harris County, but the investigation into the matter was
790

Id.
Letter from [Abortion Doctor #2] M.D., M.P.H., Ph.D. to Rep. Marsha Blackburn, Chairman, House Select
Investigative Panel 4 (Nov. 16, 2016), Exhibit 7.3.
792
[Abortion Doctor #2], Boulder Abortion Clinic Renovation and Security Upgrades, crowdrise,
https://www.crowdrise.com/boulder-abortion-clinic-renovations-and-security-upgrades. As of December 13, 2016,
[Abortion Doctor #2] had earned $53,325 on the fundraising website.
791

285

deficient. After [Abortion Doctor #3]s attorney agreed to forward a document request from the
Panel to his client, the Panel made such a request for documents due November 16, 2016, but
received no response to the request. Due to the gravity of the allegations against him, the Panel
made a criminal referral forthwith to both the United States Attorney General and the Texas
Attorney General on December 7, 2016. The allegations of violations of both federal and state
law are recounted below.
2. Allegations Against [Abortion Doctor #3]
[Abortion Doctor #3] is an abortion provider who has operated at three locations in
Houston, Texas and one in Dallas. Several former employees who worked with him at one or
more of the Houston locations have come forward alleging numerous violations of law.
According to several of his employees, including [Employee #1] and [Employee #2], who
were medical assistants, and [Employee #3], who assisted with administrative tasks, numerous
patients of [Abortion Doctor #3] delivered infants alive prior to their demise, which the doctor
himself brought about. Specifically, [Employee #1], who assisted the doctor in the operating
room at the Aaron Womens Clinic (Aaron), estimated that [d]uring a typical week with a full
patient load, . . . [Abortion Doctor #3] would perform abortions at 20 or more weeks gestation,
i.e., later in the second trimester or in the third trimester, on approximately 40 patients.793 Of
that number, [Employee #1] asserted:
approximately three or four infants would show signs of life. This
typically happened when infants were extracted from the cervix in a
breech position. At times, the infant would slide completely out
because of the extent of the dilation caused by the laminaria
administered to patients. In all such cases, [Abortion Doctor #3]
would terminate their lives. The signs of life they exhibited would
include movement of the stomach as the infant breathed or
movement of the toes or fingers.794
[Abortion Doctor #3] would terminate the lives of these infants, [Employee #1] further
alleged based on those incidents she witnessed, by any of several methods, including the
following:
snipping the infants spinal cord with scissors; cutting the neck with
Sopher forceps or similar instruments; twisting the infants head;
using forceps, other instruments, or his finger to crush the soft
spot of the infants head, or crushing it by the same means through
its stomach; or inserting his finger down its throat. If the infants
cranium was coming out first, he would usually use his index finger

793
794

Affidavit of [Employee #1], Dec. 5, 2016 ([Employee #1] Aff.), 1-2, Exhibit 7.4. [Warning: Graphic Content]
Id. 3.

286

to puncture its head, but if it was coming out feet first, he would
instead insert an instrument in the back of the infants head.795
Several of the same allegations were also made by [Employee #2].796
[Employee #3] was not in the treatment rooms when abortions took place, but she alleges
she learned from her coworkers of numerous infants whose lives were terminated by [Abortion
Doctor #3] after showing signs of life following partial or full extraction from the uterus.797 On
one occasion, she stated that she learned from a coworker of an infant killed by the doctor after
surviving an abortion; as he was preparing to put it into a bag for disposal, she maintained, the
infant had opened up his eyes and grabbed his hand.798
[Employee #1] stated that [o]f the three to four infants terminated in a typical week by
[Abortion Doctor #3] while showing signs of life, on average, approximately one or two would
be put to death after they had left the birth canal entirely. The balance were terminated while
they were partially out of the birth canal.799 [Employee #1] added that she never observed
[Abortion Doctor #3] make an attempt to keep alive or resuscitate any infant who showed any
signs of life or to direct anyone else to do so, an observation consistent with [Employee #3]s
understanding.800
[Employee #1] also alleged that [Abortion Doctor #3] performed numerous abortions
during the third trimester in cases that did not involve any serious threats to the mothers or the
infants health.801 [Employee #2] asserted, As long as the patients had the cash, he was going
to do it past the 25 weeks.802 Four photographs identified by [Employee #1] and [Employee #3]
as taken in the sterilization room of one of [Abortion Doctor #3]s clinics, the Womens
Pavilion, in 2012 depict the remains of infants clearly in their third trimester when they were
allegedly terminated by [Abortion Doctor #3].803 According to [Employee #1], the tears in the
neck line visible in the photos are inconsistent with terminations done while the infant[s
were] entirely inside the uterus.804 Thus, besides being late-term abortions, they were likely
either partial-birth abortions or homicides committed after full delivery.
[Employee #1] and two other employees at the clinic, [Employee #3] and [Employee #4],
additionally alleged that the doctor regularly falsified sonogram results to misrepresent the
795

Id. 4.
See Redacted videosee key. [hereinafter Redacted video] (Sometimes he would go through the stomach as
well. . . . He would like force it [the instrument] through the stomach . . . and he twists it.) (he would put, like, his
finger . . . through the throat) (statements of [Employee #2]).
797
Affidavit of [Employee #3], Dec. 6, 2016 ([Employee #3] Aff.), 2, Exhibit 7.5. [Warning: Graphic Content]
798
Redacted video.
799
[Employee #1] Aff. 5.
800
Id. 5; [Employee #3] Aff. 2.
801
[Employee #1] Aff. 6.
802
Redacted video.
803
[Employee #1] Aff. 6; [Employee #3] Aff. 3. According to [Employee #3], the photos were taken July 26,
2012. Id.
804
[Employee #1] Aff. 6.
796

287

gestational age of the fetus. Some sonograms, they maintained, would be falsified to overstate
the gestational age of the fetus in order to overbill customers.805
In other cases, according to [Employee #1] and [Employee #3], sonograms would be
falsified to conceal the advanced gestational age of the fetus beyond the legal limit in Texas.806
[Employee #1] claimed:
I have witnessed this happen in cases involving fetuses as old as 28
weeks. [Abortion Doctor #3] would typically tell his ultrasound
technician in cases involving fetuses beyond a certain gestational
age to allow him to perform the ultrasound himself; he would then
bring the patient an ultrasound picture showing another fetus at the
gestational age he was misrepresenting to the patient.807
An affidavit from a patient attached hereto alleges another specific case of manipulation: [Patient
#1], a woman who obtained an abortion in 2002 at 24 to 25 weeks gestation, worried that I
was too far along. The girl doing my ultrasound told me that ultrasounds can be manipulated.
The clinic determined me to be 23 weeks.808 On two occasions that I witnessed, [Employee
#1] also alleged that [Abortion Doctor #3] failed to inform a patient she was pregnant with
twins.809
According to [Employee #1] and [Employee #3], the doctor would regularly make use
of pre-drawn medicine, including Demerol and Nubain, without properly logging or storing
it. They added:
This included improperly storing medicine in a food refrigerator. On
one occasion, [Abortion Doctor #3] concealed these practices during
an inspection from the Harris County Public Health office by having
a nurse put pre-drawn medicine in basins, which she hid in the trunk
of her car while the inspector was present.810
[Employee #1] and [Employee #3] also allege the doctor failed to keep a registered nurse on site
in the recovery room at Aaron, which left unqualified workers to draw and administer drugs.811
[Employee #1] added that [Abortion Doctor #3] concealed this deficiency from authorities by
hir[ing] a nurse from a temp agency for a few days at a time when a government inspection was

805

Id. 7; [Employee #3] Aff. 4; Statement of [Employee #4], Nov. 23, 2012, at 1, Exhibit 7.6.
[Employee #1] Aff. 7; [Employee #3] Aff. 4.
807
[Employee #1] Aff. 7.
808
Affidavit of [Patient #1], June 17, 2013, Exhibit 7.7.
809
[Employee #1] Aff. 8.
810
Id. 9; [Employee #3] Aff. 5. See also Redacted video.
811
[Employee #1] Aff. 10; [Employee #3] Aff. 6.
806

288

scheduled.812 [Employee #1] recorded examples of storage, recordkeeping, and personnel

violations in an undercover video she took in 2011.813
Additionally, according to [Employee #1]:
[Abortion Doctor #3] would regularly fail to observe proper
sterilization procedures. This included the doctors habitual reuse of
a bottle of Betadine, which is used for cleaning prior to the
procedure, that was not cleaned or stored, and which he handled with
his gloved hand for patient after patient when going inside the
cervix. Additionally, after removing instruments such as HawkinsAmblers dilators and Bierer and Sopher forceps from sterile
packages, he would place unused instruments back in the sterile
package to use on other patients. He often would do so wearing
gloves that he did not change between seeing one patient and
another, or between trips to the restroom. . . . Instruments in
[Abortion Doctor #3]s clinic were not regularly soaked in
sterilizing solutions as they needed to be for specified periods of
time in order to be sterile. The exception to this occurred prior to
government inspections. The vast majority of the doctors assistants
in the sterilization room were uninformed on proper methods of
sterilization. In order to reduce his costs, [Abortion Doctor #3] also
habitually disposed of biohazardous waste in standard garbage bags
instead of sterile bags required for such waste.814
The same failure with respect to sterilization was also alleged by [Employee #2], [Employee #3],
and [Employee #4].815
3. Violations of Applicable Laws
Federal law makes clear that infants that are born, regardless of whether naturally or by
extraction during an abortion, are entitled to the same protections given to every other person.
Under the Born-Alive Infants Protection Act of 2002, every infant member of the species homo
sapiens who is born alive at any stage of development is considered a person.816 This is so
whenever an infant undergoes complete expulsion or extraction from his or her mother and
has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles,
regardless of whether the umbilical cord has been cut, and regardless of whether the expulsion or

[Employee #1] Aff. 10. For additional information regarding the deficiencies in [Abortion Doctor #3]s nursing
staff and other allegations regarding possible violations at his clinics, see Statement of [Employee #1] in support of
Complaint against [Abortion Doctor #3], D.O., Apr. 26, 2010, Exhibit 7.8.
813
Clinic in Texas video by [Employee #1].
814
[Employee #1] Aff. 11-12. See also Statement of [Employee #1] in support of Complaint against [Abortion
Doctor #3], D.O., Apr. 26, 2010, at 3.
815
Redacted video; Statement of [Employee #4], Nov. 23, 2012, at 1.
816
1 U.S.C. 8(a).
812

289

extraction occurs as a result of natural or induced labor, cesarean section, or induced

abortion.817
The Partial-Birth Abortion Ban Act of 2003 makes clear that such protections apply even
if the infant is only partially extracted from the mothers body at the time its life is ended.
Specifically, a prohibited partial-birth abortion occurs when a person knowingly commits an
overt act . . . that kills the partially delivered living fetus after the fetus is partially delivered
with its entire head outside the body of the mother, or, in the case of breech presentation, any
part of the fetal trunk past the navel.818 The only exceptions occur when such a procedure is
necessary to save the life of a mother whose life is endangered by certain categories of physical
conditions.819 Violations of the 2003 act are punishable by fines, imprisonment for up to two
years, or both.820
The foregoing allegations advance numerous federal violations against [Abortion Doctor
#3]of the Partial-Birth Abortion Ban Act in those cases involving his terminations of partially
delivered infants and of the Born-Alive Infants Protection Act in those cases where the infants
have completely exited a mothers body. In at least the latter cases, they also amount to
allegations that [Abortion Doctor #3] violated Texas criminal homicide statutes. First, the
allegations constitute murder, defined by the Texas Penal Code as intentionally or knowingly
caus[ing] the death of an individual.821 Second, the allegations against [Abortion Doctor #3]
constitute capital murder under Texas law in both of the following circumstances, either one of
which is sufficient to establish that offense:

the person murders more than one person . . . during different criminal transactions but
the murders are committed pursuant to the same scheme or course of conduct;822 and

the person murders an individual under 10 years of age . . . .823

The murders alleged against [Abortion Doctor #3] occurred on a repeated basis, and all occurred
pursuant to his course of conduct as a provider of abortion who was alleged to have
systematically killed any infant aborted while showing signs of life. The second circumstance is
independently established by the obvious fact that every alleged victim was under 10 years of
age.
[Abortion Doctor #3]s alleged conduct would also violate the gestational age limit
established under Texas law. Former employees of the doctor allege he performed abortions as
late as the third trimester.824 Third trimester abortions are prohibited with narrow exceptions,
inapplicable according to the allegations in the instant case, where the abortion is necessary to
817

1 U.S.C. 8(b).
18 U.S.C. 1531(b)(1).
819
18 U.S.C. 1531(a).
820
Id.
821
Tex. Penal Code 19.02(b)(1).
822
Tex. Penal Code 19.03(a)(7).
823
Tex. Penal Code 19.03(a)(8).
824
[Employee #1] Aff. 6; [Employee #3] Aff. 2.
818

290

prevent the death of the woman, the unborn child has a severe, irreversible brain impairment;
or . . . the woman is diagnosed with a significant likelihood of suffering imminent severe,
irreversible brain damage or . . . paralysis.825 Since H.B. 2 became effective October 29, 2013,
abortions additionally have been prohibited when the probable post-fertilization age of the
unborn child is 20 or more weeks.826 [Abortion Doctor #3]s abortion practice is believed to
continue to the present day, so it merits investigation whether he has violated both gestational
limits.
The allegations that [Abortion Doctor #3] regularly falsified sonogram results to
misrepresent the gestational age of the fetus in order to overbill also potentially implicate both
state and federal law. Regardless of whether the patient or another entity is responsible for
payment, Texas law clearly prohibits fraudulent billing. Such conduct would constitute a form of
theft827 in addition to violating Texas prohibition on insurance fraud.828 In those cases in which
patients were eligible for Medicaid coverage, such allegations would implicate numerous federal
criminal prohibitions on false statements to federal agencies829 and on false statements involving
health care benefit programs,830 as well as the prohibitions on health care fraud.831 Such conduct
would also violate the federal False Claims Act832 and Texas prohibition of Medicaid fraud.833
Other provisions of Texas law prohibit additional conduct alleged above on the part of
[Abortion Doctor #3], including the following:

Misrepresentation of sonogram readings: In addition to violating the above-cited statutes

prohibiting fraud, tampering and altering records containing patient data is prohibited
under 25 Tex. Admin. Code 135.9(d).

Failure to properly store and log medication: The obligation to maintain and provide
drugs safely and to properly log their use is set forth in detail under 22 Tex. Admin. Code

825

Tex. Occ. Code 164.052(a)(18). The Texas Health and Safety Code contains an additional prohibition of thirdtrimester abortions, under which such abortions are permitted only when they are necessary to prevent the death or
a substantial risk of serious impairment to the physical or mental health of the woman or the fetus has a severe and
irreversible abnormality, in which case the physician is required to submit a written certification of the applicable
conditions to the Department of State Health Services. Tex. Health & Safety Code 170.002(b)-(c).
826
Tex. Health & Safety Code 171.044, 171.045. Exceptions apply when abortion is deemed necessary to avert
the womans death or a serious risk of substantial and irreversible physical impairment of a major bodily function,
other than a psychological condition. Tex. Health & Safety Code 171.046. Note that these provisions of H.B. 2
were not challenged in Whole Womans Health v. Hellerstedt, 136 S. Ct. 2292 (2016).
827
Tex. Penal Code 31.03.
828
Tex. Penal Code 35.02.
829
18 U.S.C. 1001; 18 U.S.C. 287. An accompanying prohibition on conspiracy in connection with such claims
is established by 18 U.S.C. 286.
830
18 U.S.C. 1035.
831
18 U.S.C. 1347; 42 U.S.C. 1320a-7b(a). If fraud is proven to have been carried out by utilizing either the
mails or other applicable interstate carriers or communications, the federal mail and wire fraud statutes would also
be implicated. See 18 U.S.C. 1341, 1343.
832
31 U.S.C. 3729(a)(1).
833
Tex. Penal Code 35A.02.

291

 291.76 and made applicable to ambulatory surgical centers under 25 Tex. Admin. Code
135.12.

Lack of adequate medical staff: 25 Tex. Admin. Code 135.7 requires health care
practitioners to meet numerous requirements that include necessary and appropriate
training and to adhere to state law and the standards and ethics of their professions. 25
Tex. Admin. Code 135.15 specifies requirements for an organized nursing service
under the direction of a qualified registered nurse and other personnel that must be
present at the medical facility. [Abortion Doctor #3]s former employees allege a
violation of these sections. Additional investigation is warranted into whether clinic
practices were in compliance with other requirements for adequate medical staff,
including 25 Tex. Admin. Code 135.10, which addresses additional facility
requirements, and 25 Tex. Admin. Code 135.11, which addresses anesthesia and
surgical services.

Failure to observe proper sterilization procedures and disposal practices: 25 Tex. Admin.
Code 135.11(b)(12) requires the development, implementation, and enforcement of
such procedures, and 25 Tex. Admin. Code 135.52(d)(14) requires sterilizing facilities
to be included and properly maintained and utilized.

Fraudulent concealment from government authorities of the foregoing alleged violations:

The fabrication, alteration, and in applicable cases concealment involved in these
allegations entail conduct proscribed by Tex. Penal Code 37.09. It also subverts the
states right to inspect facilities containing controlled substances pursuant to Tex. Health
& Safety Code 481.181.

E. University of New Mexico and Southwestern Womens Options

As noted above, Albuquerque, New Mexico, is one of the known providers of late-term
abortions. SWWO openly performs a large quantity of abortions into the third trimester, and
UNM Hospital will provide abortions beyond 25 weeks where there is a maternal indication or
a fetal indication.834 Yet neither UNM nor SWWO appears to have any apparatus or procedure
to ensure the survival of infants who show signs of life following extraction from the uterus. This
is evident from [Dr. Administrator]s deposition testimony when she was questioned on this
subject:
Q
. . . Im trying to understand if any of the doctors that were
on the fellows program that . . . went to Southwestern Womens
Options, or any of the doctors from the University of New Mexico
that were on a fill-in rotation at Planned Parenthood, or any of the
doctors at the University of New Mexico reproductive health center,
or any of the doctors at the University Hospital ever told you,

834

[Dr. Administrator] Tr. at 46.

292

reported to you, or discussed with you, that an abortion failed and a

live birth resulted?
A
. . . The answer is no at the Planned Parenthood and
Southwest Womens Options and the Center for Reproductive
Health. There are situations in the hospital where a planned
abortion, an induction of labor for a fetus, for example, with severe
anomalies is born alive.
Q
If one of the fellows from UNM had been at Southwest,
would they have been trained in what to do if a child was born alive?
A

I don't know.

Q
So does your curriculum call for training of doctors of what
to do if a child is born alive because of an induced abortion?
A

No.

No training at all?

No.

Theres no resuscitation training?

OB/GYN doctors do not resuscitate neonates.

Q
So who at the Southwest Clinic would do that resuscitation
if it was necessary?
. . . [A] I dont know.835
[Dr. Administrator] was subsequently asked about a provision in UNMs own protocol for
infants that survive abortion: When an induced abortion results in a live-born infant showing
any signs of life, such as a heartbeat or voluntary movement, a birth certificate should be
completed. . . . A death certificate will be completed if the infant dies.836 When asked why such
language would be included in the UNM protocol, [Dr. Administrator] expressed her ignorance
of, and perhaps obliviousness to, the subject matter:
A
So I was responsible for editing and helping to draft and
review this document, except for the administrative procedures. The
administrative procedures are -- these are procedures that are -- that
835

[Dr. Administrator] Tr. 24-25.

[Dr. Administrator] Tr. 28-29 (quoting UNMHSC, Second Trimester Pregnancy Termination, D&E and
induction of labor 2, UNM01686).
836

293

are carried out by nursing. So this -- this was added after the
medical content of the document. And this -- this was added
by -- by nursing.
Q

Do you agree with that statement?

A
So I think thatthat we actually need to update this
document to reflect what we
Q
Welcome to have you update it. My question is: do you
agree with the statement? . . .
A
So there are requirements through the hospital and through
the state, and we comply withwith those requirements. I am not
sure right now that these are what conform to the current
requirements of the state and of the institution.
Q

Do you agree with the statement?

I dont understand your question.

Q
Its a very easy question to answer. If an induced abortion
results in a live-born infant showing any signs of life, such as a
heartbeat, like A[P]GAR 1, or voluntary movement, a birth
certificate should be completed.
A
So a birth certificate is an administrative matter that I dont
have an opinion about. I follow the appropriate administrative
procedures as outlined by the institution and the state, but its not
something I have an opinion about.
Q
So you have no opinion on whether this policy is a good
policy, correct policy, what we should do, what we shouldn't do; no
opinion at all?
A
The medical component of this policy I stand behind. The
administrative procedures, again, are not under my purview. I am
very much in agreement with following the institution and the state
regulations around birth certificates.
Q

So is the diagnosis part of the doctors responsibility?

Diagnosis of what?

294

Q
Of a patients situation? Is that what the doctor does, they
diagnose patients? I just want to read you the rest of this paragraph,
in light of diagnosis. The diagnosis on the woman's chart should
be induced abortion, secondary diagnosis giving the indication for
the procedure. In addition, a diagnosis of live-born infant should
be made as a secondary diagnosis. This reflects the unusual
outcome of the live birth from an induced abortion. Do not make an
entry in the delivery room log. Where would that entry be made?
A

I dont know.837

[Dr. Administrator] would not directly answer the question whether the decision to resuscitate a
child that comes out of the birth canal alive should be left to the woman and doctor alone,
suggesting that there is no answer or that the answer would depend on the individual
circumstances of the patient.838 When she was read the language of the Born-Alive Infants
Protection Act and asked if she agreed with it, she responded, Im not familiar with the law.839
She admitted she never discussed the law with counsel and did not understand the relevance of
this to my practice.840
Coming from the official who is arguably most responsible for making UNM an abortion
provider and providing the same function to outside clinicsan official responsible for training
in multiple competencies in abortion and family planningthis testimony is a startling reflection
of the absence of attention given to any standard of care for infants that survive the abortion
procedure.
When [Clinic A Dr. #1] was questioned about infants showing signs of life following
abortions, she denied ever seeing such signs of life and testified that if you want to talk about
signs of life, . . . I dont know what criteria would necessarily be applied to that, but I would
have to extend my knowledge of obstetrical practice.841 She surmised that such signs would be
assessed by . . . an Apgar score, meaning respiration, color, the color of the neonate, grimace,
reflexes to certain stimulus, crying, only to be challenged by Rep. Harris, whose experience as a
physician includes being the chief of obstetric anesthesiology at the Johns Hopkins Hospital:
Ive been in the delivery room a lot of times and witnessed Apgar scores of zero and one on
babies that were resuscitated.842 Did she in fact conclude that if a baby didnt grimace or didnt
have reflex response to . . . painful stimulus or wasnt breathing, there was no sign of life?
She responded, Yes.843 When Rep. Harris pressed further for clarification, [Clinic A Dr. #1]
admitted that she was not even performing an Apgar score.844 On assess[ing] signs of life, she

837

[Dr. Administrator] Tr. at 30-32.

[Dr. Administrator] Tr. at 51-53.
839
[Dr. Administrator] Tr. at 56.
840
[Dr. Administrator] Tr. at 56-57.
841
[Clinic A Dr. #1]Tr. at 230.
842
[Clinic A Dr. #1] Tr. at 230-31.
843
[Clinic A Dr. #1] Tr. at 232.
844
[Clinic A Dr. #1] Tr. at 233.
838

295

continued, I havent thought about this. I have not given this deep consideration.845 Despite the
fact that SWWO performed abortions in the third trimester, the infant was not even routinely
checked for a heartbeat.846 This was the case even though [Clinic A Dr. #1] admitted there were
cases in which an infant exited the womb spontaneously, before it was expected to do so.847
The testimony of both abortion providers suggests a lack of medical training and of any
sense of obligation to be trained to preserve the life of an infant that survives the abortion
procedure. It reflects a philosophy that a right to abortion somehow carries a guarantee of the
death of the infant expelled during the procedure.

845

[Clinic A Dr. #1] Tr. at 234.

[Clinic A Dr. #1] Tr. at 234-35.
847
[Clinic A Dr. #1] Tr. at 250.
846

296

VIII.

Case Studies of the Fetal Tissue Industry Planned

Parenthood

Chapter VIII Redaction Key:

1. [PP Witness #1] is an abortion provider in Los Angeles, California, an executive with
Planned Parenthood Federation of America (PPFA) who is in charge of the PPFA Manual
of Medical Standard and Guidelines.
2. [PP Witness #2] is a manager of research projects at Planned Parenthood Gulf Coast.
3. [PP Witness #3] is a university professor, an abortion provider and serves on the PPFA
National Medical Committee.
4. [PP Witness #4] works for the Consortium of Abortion Provider Services at PPFA which
provides technical assistance to PPFA affiliate clinics.
5. [PP Doctor #1] is an abortion provider in Los Angeles, California, who also works for the
Medical Directors Council.
6. [PPGC Abortion Services Official] is a manager of abortion services at PPGC.
7. [PPFA Executive] works for the Medical Standards Department at PPFA
8. [PPFA Medical Officer #1] is a PPFA official who was responsible for medical issues
9. [PPFA Medical Officer #2] is a PPFA official who was responsible for medical issues
10. [PPFA Lawyer] is a legal official at PPFA.
11. [CRR lawyer] works for the Center for Reproductive Rights.
12. [ANSIRH lawyer] works for Advancing New Standards in Reproductive Health.
13. [NARAL executive] works for the Policy department at the National Abortion and
Reproductive Rights Action League.
14. [StemExpress Founder and CEO] refers to the founder and CEO of StemExpress
15. [Abortion Doctor] is any doctor who provides abortions.
16. [Researcher FT] refers to any person who is involved in fetal tissue transactions.
297

17. [Procurement Technician] refers to any person who procures fetal tissue.
A. Summary
Planned Parenthood executives who spoke with the Panel noted that 2016 is the 100th
anniversary of the founding of Planned Parenthood. A closer look at the history of the
organization, however, leaves little to celebrate. The organization was founded by eugenicists
who believed in limiting the rights of people to form families and have children if they had
mental or physical disabilities or were of the wrong race.
Harvard studies about Planned Parenthoods business model have pointed out financial
struggles the organization has faced in recent years, including smaller margins and lower
revenues. Substantial evidence exists that Planned Parenthood clinicsat least 51 timeshave
overbilled Medicaid and improperly billed items to cover the costs of abortion services, in
violation of the Hyde Amendment
During some of Planned Parenthoods difficult financial years, tissue procurement companies
like StemExpress saw an opportunity to market their services to Planned Parenthood affiliate
clinics and even the entire Federation. This move was welcomed by top Planned Parenthood
executives, some of whom were remarkably candid about the revenue possibilities for clinics.
However, the relationship that has formed between tissue procurement companies and
abortion clinics and universities is fraught with questionable practices, including the possible use
of illegal, late-term abortion practices to procure the best tissues and organs, violating federal
guidelines on patient consent, and systematic violations of patient HIPAA rights. The Panel has
been investigating these practices for the past year.
This chapter reveals the findings of that investigation.
B. Planned Parenthood: A Corrupt Founding
According to the 2014 audited financial statement of Planned Parenthood Federation
(PPFA) and related entities:
The Federation is . . . affiliated with 68 independent medical and
related entities, and 101 ancillary entities (including 34 Political
Action Committees and 55-501(c)(4) organizations), all of which
are separately incorporated in their respective states and which
collectively constitute PPFAs membership.848
Planned Parenthood operates 57 affiliates directly as of 2016, a number that has been
declining since 2009 based on annual reports released by the organization. In 2015, for example,
848

Planned Parenthood Federation of America, Inc. and Related Entities: Consolidated Financial Statements and
Supplementary Information 9 (June 30, 2014 and 2013),
https://www.plannedparenthood.org/files/5014/1936/7155/PPFA_Audited_FS_FY2014.PDF [hereinafter PPFA
2014 Financial Statements].

298

PPFA oversaw 59 affiliates which operated 667 health centers (outpatient clinics) in the United
States. When asked by House Energy and Commerce Committee staff why the number of
affiliates has declined in recent years, PPFA attorneys responded that it is due primarily to
mergers, and in some cases disaffiliation. . . . In cases of disaffiliation, contributing factors range
from compliance issues, the adoption of core services, protection of the Trademark and strategic
restructuring.849
Until recently, PPFA also included the Planned Parenthood Foundation, which raised
funds for various projects and affiliates and which was collapsed into PPFA in 2013.850 The
Planned Parenthood Action Fund (incorporated in 1989)851 engages in public and political
advocacy. Another entity, Voxent (incorporated as of 2010)852 exists to acquire medical
technology for PPFA. Additionally, PPFA maintains many programs and initiatives such as the
Consortium of Abortion Providers (CAPS) which raises funds to subsidize abortion services for
affiliates and provides technical assistance, including for fetal tissue programs. The PPFA also
maintains three global offices.853
This year, 2016, marks the 100-year anniversary of Planned Parenthood. The
organization has its origin in a single birth control clinic in Brooklyn in 1916.854 Today it has
become the highest volume abortion provider in the United States, and in 2015 alone performed
323,999 abortions.855
Before it was renamed Planned Parenthood in 1942, the reproductive health services
provider was known as the American Birth Control League (ABCL).856 Among the founders of
the ABCL were a group of eugenicists, including Planned Parenthood founder Margaret Sanger,
who sought to reduce and control population growth, including among the African American
community. Sanger saw the eugenics movement as a chance to rid civilization of racial,
political and social problems.857 In a 1921 article titled The Eugenic Value of Birth Control
Propaganda, she wrote:
Seemingly every new approach to the great problem of the human
race must manifest its vitality by running the gauntlet of prejudice,
ridicule and misinterpretation. Eugenicists may remember that not
many years ago this program for race regeneration was subjected to
849

U.S. House of Representatives Committee on Energy & Commerce Subcommittee on Oversight & Investigations
Follow-Up Questions 8 (Aug. 20, 2015) [PPFA-HOU_E&C-000169], Exhibit 8.1.
850
PPFA 2014 Financial Statements, at 9.
851
Id. at 8.
852
Id.
853
Planned Parenthood website, https://www.plannedparenthood.org/about-us/planned-parenthood-global/contactthe-international-program.
854
Planned Parenthood Minnesota, North Dakota, and South Dakota website,
https://www.plannedparenthood.org/planned-parenthood-minnesota-north-dakota-south-dakota/who-weare/history/1916-1952.
855
Planned Parenthood Annual Report 30 (2014-2015),
https://www.plannedparenthood.org/files/2114/5089/0863/2014-2015_PPFA_Annual_Report_.pdf.
856
The Margaret Sanger Papers Project website,
https://www.nyu.edu/projects/sanger/aboutms/organization_abcl.php.
857
Margaret Sanger, The Eugenic Value of Birth Control Propaganda (Oct. 1921),
https://www.nyu.edu/projects/sanger/webedition/app/documents/show.php?sangerDoc=238946.xml.

299

the cruel ridicule of stupidity and ignorance. Today Eugenics is

suggested by the most diverse minds as the most adequate and
thorough avenue to the solution of racial, political and social
problems. The most intransigent and daring teachers and scientists
have lent their support to this great biological interpretation of the
human race. . . . The doctrine of Birth Control is now passing
through the stage of ridicule, prejudice and misunderstanding. . . .
Gradually the criticisms are lessening-understanding is taking the
place of misunderstanding. The eugenic and civilizational value of
Birth Control is becoming apparent to the enlightened and the
intelligent.858
Sanger believed eugenics would make the human race healthier by ridding society of people
whom she saw as a burden: those who were perpetuating a cycle of poverty and illness. In her
1922 book Pivot of Civilization, she wrote:
Those vast, complex, interrelated organizations aiming to control
and to diminish the spread of misery and destitution and all the
menacing evils that spring out of this sinisterly fertile soil, are the
surest sign that our civilization has bred, is breeding and is
perpetuating constantly increasing numbers of defectives,
delinquents and dependents. My criticism, therefore, is not directed
at the failure of philanthropy, but rather at its success.859
She calls those with mental disabilities a dead weight of human waste and a burden of
unthinking and indiscriminate fecundity. Sanger again bemoans the perpetuation of defectives,
delinquents and dependents.860
Further, in a 1939 report co-authored by her organizations secretary, Mary Woodward
Reinhardt, and her personal secretary Florence Rose, Sanger wrote that negroes present the
great problem of the South.861 In a letter that same year to her friend Clarence Gamble, she
stressed the importance of training an African-American physician so the community will more
or less lay their cards on the table which means their ignorance, superstitions, and doubts.862
She was concerned that African-Americans would be more open to the idea of birth control if
they were speaking to a doctor who shared their race. She then wrote, We do not want the word
to go out that we want to exterminate the Negro population and the minister is the man who can
straighten out that idea if it ever occurs to any of their more rebellious members,863 indicating
at bestthat she was concerned with the growth of African-American families.
858

Id. (emphasis added).

Margaret Sanger, The Pivot of Civilization, Chapter V: The Cruelty of Charity,
http://www.gutenberg.org/files/1689/1689-h/1689-h.htm (emphasis added).
860
Id.
861
Birth Control or Race Control? Sanger and the Negro Project, The Margaret Sangers Papers Project,
https://www.nyu.edu/projects/sanger/articles/bc_or_race_control.php.
862
Letter from Margaret Sanger to Dr. C. J. Gamble (Dec. 10, 1939),
https://libex.smith.edu/omeka/files/original/d6358bc3053c93183295bf2df1c0c931.pdf.
863
Id.
859

300

For all her shocking and discriminatory statements, the organization she founded,
Planned Parenthood Federation of America, has not shied away from the legacy of their founder.
Since 1966, PPFA has given individuals of distinction in recognition of excellence and
leadership in further reproductive health and reproductive rights the Margaret Sanger Award.864
They have further appointed her grandson, Alexander Sanger, as Chair of the International
Planned Parenthood Council.865
C. Planned Parenthood: Problems with the Business Model
In 1994, PPFA created a reinvention team in partnership with the Harvard Business
School to address problems that PPFA saw in its affiliates. There was a general concern that the
financial condition of the national organization had deteriorated.866 In short, net margins were
declining, smaller affiliates were faring poorly, and private fundraising (20% of affiliate revenue)
was declining. The nationwide rise of managed care clinics also posed several threats to PPFA,
most importantly in the area of client composition.
First, most managed care plans increasingly covered the reproductive services that
Planned Parenthood affiliates offered. Planned Parenthood affiliates, therefore, needed to expand
their services. Private physicians also began to serve more Medicaid patients, taking a portion of
Planned Parenthoods customer base with them. At the same time, the number of uninsured
patients grew, increasing the demand at Planned Parenthood affiliates for reduced-cost services.
The reinvention team drafted a proposal recommending a shift from a specialty provider model
to a broad range of women-centered healthcare; creating a for-profit entity by which PPFA could
distribute revenue; and restructuring governance of PPFA to add weight to the vote participation
by the affiliate clinics with more clients.867 When the draft was reviewed, some complained that
abortion was mentioned only eight times in the entire, 123-page document.868 The second draft,
therefore, explicitly embraced protecting abortion rights as a key function.869
Throughout their reinvention process, the abortion giant was careful to protect its most
lucrative procedure. Former Planned Parenthood facility director Abby Johnson blew the whistle
on the importance Planned Parenthood placed on abortion quotas. She shared a photo in 2014 of
an award given to Planned Parenthood of Aurora, Colorado, by Planned Parenthood of the Rocky
Mountains for exceeding abortion visits in the first half of FY13 compared to first half of
FY12.870 Johnson wrote on her blog that when she expressed concerns to her supervisor about
the pressure to increase the number of abortions at their clinic, the supervisor laughed and said,
864

Planned Parenthood website,

https://www.plannedparenthood.org/about-us/newsroom/ppfa-margaret-sanger-award-winners.
865
International Planned Parenthood Federation Western Hemisphere Region website,
https://www.ippfwhr.org/en/who-we-are/alexander-sanger.
866
Elaine V. Backman & V. Kasturi Rangan, Planned Parenthood Federation of America (C), Harvard Business
School, Feb. 13, 1998, at 1, Exhibit 8.2.
867
Elaine V. Backman & V. Kasturi Rangan, Planned Parenthood Federation of America (B), Harvard Business
School, Oct. 21, 1997, at 2, Exhibit 8.3.
868
Id. at 3.
869
Id. at 4.
870
Image of Planned Parenthood of the Rocky Mountains Certificate on LifeNews website,
http://lifenews.wpengine.netdna-cdn.com/wp-content/uploads/2014/06/plannedparenthood108.png.

301

But Abby, abortion is how we make our money.871 Moreover, in 2010, affiliates were asked to
make sure that at least one of their clinics perform abortions.872 Based on PPFAs own numbers
from annual reports, abortion accounts for about 30% of its annual income.
Almost 15 years after the initial reinvention process, in 2008, PPFA was faced with more
financial troubles. According to a 2009 Harvard report:
[The Great Recession had] further exacerbated fundraising
challenges at both the local and national levels . . . . Everything from
reduction in state family-planning budgets to worsening credit
crunches to reduced donations influenced the wave of
consolidations that had already been occurring throughout the
organization. Reducing costs became a key focus due to continued
revenue declines. Affiliates were asking themselves if there were
more efficient ways of running their operations.873
Some Planned Parenthood executives have been remarkably candid about
the financial problems faced by the organization and the abortion industry as a
whole. The Panel found the following panel discussion at a national meeting:
[PP Witness #4]: So its true that we have kept the price low, but
it is those of us who are in this room who have kept that price low.
That, we have in some part done that to ourselves. And I understand
all the reasons behind that, but that other case in point, that were
not doing ourselves any favors by doing that.
[ANSIRH lawyer]: Yeah, I mean, and I think the tough thing is, if
you have competitors in a market, I mean if you have more than one
provider in a market, I think lots of providers feel like if they raise
their prices at all to reflect new costs that have been imposed on
them, that the other providers in the market will not do so, and then
they will lose all their business and theyll go out of business. So, I
think, its, this is a really tough thing
[NARAL executive]: Or you get a Kermit Gosnell. You get a
predator.
[ANSIRH lawyer]: Yeah, so, yeah. I think theres a lot of areas of
the country where I think people just feel that they cannot adjust
their prices to reflect the actual costs because of competition, and as
a result, I mean, as a result, providers are really struggling, its also
871

Abby Johnson, And Then There Were None blog, July 22, 2014,
http://archive.aweber.com/exposingthelie/A1RpD/h/Abortion_Quotas_EXPOSED_.htm.
872
Local Planned Parenthood Chapter Drops Affiliation, Corpus Christi Caller Times, Dec. 20, 2010,
http://archive.caller.com/news/local-planned-parenthood-chapter-drops-affiliation-ep-359672010-316353321.html.
873
Allen Grossman, Thomas Steenburgh, Lauren Mehler, & Matt Oppenheimer, Planned Parenthood Federation of
America in 2008, Harvard Business School, Oct. 29, 2010, at 9, Exhibit 8.4.

302

probably one of the most efficiently provided forms of health care

in the entire country [audience laughter]. Because, you know, people
have managed to just take on all these new costs without raises
prices. I mean its really quite shocking.
[PP Witness #4]: Oh I agree, I mean, and I think its the tenacity of,
again, many in this room that have hung on for so long to those early
business models that have allowed it to work. But as a long-term
strategy, I dont think its the smartest strategy we have come
up with.
[ANSIRH lawyer]: Yeah, I agree.
[CRR lawyer]: Are you saying that maybe we should be raising
prices?
[PP Witness #4]: I think we should charge for an abortion what it
costs to provide an abortion. And right now were not. And its at
the expense of, um, at the expense of owners, and staff, and in some
cases quality. And thats not good for anybody. And if regulations
are going to continue to come down, whether they be TRAP
regulations or just changes in health carewhich I agree theres
bothI think thats just something that we need to consider.
[ANSIRH lawyer]: I think thats a good point.
[PP Witness #4]: And its a complicated case, I mean theres going
to be casualties, and theres going to be women that dont get
abortions, and theres going to be women who self-induce, and
theres going to be, you know, really adverse outcomes as a
result, so I understand its not a popular strategy, but I just
think at some point, we cant continue toand I dont want to
have a price-fixing conversation [nervous laughter]but I
dont think we can continue to provide high-quality abortions
for $500 a piece, and incur expenses like that we need to do for
ambulatory surgical centers. We have, are all, we all have our
eggsor all of our eggs are in a couple baskets. And if those baskets
ever are no longer available, I think that, again, I think that its not
a great long-term strategy for women.874
Thus, for over a decade, the economic trajectory of PPFA faced challenges of market
changes, management issues, and cash flow problems, even with one of the nations top business
schools trying to assist. It was at the end of this decade that organizations seeking to procure and
resell fetal tissue saw an opportunity. In particular, StemExpress sought to market its services to

874

Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform
FNNI0773_20150421125757 (emphasis added).

303

Planned Parenthood clinics and even to the whole of PPFA as a revenue enhancement. Fetal
tissue donation was welcomed and even encouraged by top PPFA executives:
[PP Witness #1] said that clinics on razor thin budget[s] are eager to participate in fetal
tissue programs:
But there is not a provider out there, who doesnt want this.
Everybody just sees this as a way to add another layer of good on
top of what theyre already doing. They already feel that what
theyre doing is good. Again, the majority of the providers are nonprofit organizations like Planned Parenthood or operating on a
razor-thin budget. So as low impact that you can be on them, the
better.875
[PP Witness #4] admitted to undercover journalists, We have independent colleagues
who generate a fair amount of income doing this.876 She also admitted that the national
federation cannot prevent affiliates from entering into contracts with tissue procurement
companies in order to increase revenue, thereby implying the need that some affiliates feel to
find additional sources of revenue.877
In one video,878 two journalists posing as tissue procurers are speaking to [PP Witness
#4]. She seems to agree with the journalists that fetal tissue programs are indeed profitable to
clinics. She even admits in a publicly released video that Planned Parenthoods independent
colleagues generate a fair amount of income doing this.879
Buyer I: I was thanking [PP Witness #1] for her tip of the day; Dont
bring up [unintelligible]
[PP Witness #4]: Its not dont bring it up, its . . . your headline
Buyer II: Whats it?
[PP Witness #4]: The money. Making a profit off of it. What did you
say?
Buyer I: Just that its financially . . .

875

Center for Medical Progress, Transcript of Meeting with [PP Witness #1] at 18 (July 25, 2014) (emphasis added),
Exhibit 8.5.
876
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform
0569_20150227151723.
877
Planned Parenthood Rep Admits Affiliates Cant Stop Harvesting,
https://www.youtube.com/watch?v=_4P3oHI7KFQ&index=1&list=PLJCNTv4YXhz2JbXxCADboQK_kvOAbxxH
K.
878
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform
FNNI0773_20150421063222.
879
Top Planned Parenthood Exec: Baby Parts Sales A Valid Exchange, Can Make A Fair Amount of Income,
https://www.youtube.com/watch?v=c9EU_02c5bM.

304

[PP Witness #4]: Profit [trails off]

Buyer I: . . . beneficial to the clinic . . .
[PP Witness #4]: But the truth is, is that some [Planned Parenthood
affiliates] might want to do it [fetal tissue donation] for, to increase
their revenues. And we cant stop them. We only have carrots and
sticks.880
[PP Doctor #1] said in a conversation with the journalists posing as a tissue procurement
company about remuneration for fetal tissue, Well, you know in negotiations the person who
throws out the figure first is at a loss, right? . . . I dont want to play games, I just dont want to
lowball, because Im used to low things from . . . [trails off]. 881
In a another video,882 a journalist is speaking to [Abortion Doctor] of Planned Parenthood
New York City about fetal tissue remuneration. The following transcript recounts their
conversation:
[Abortion Doctor]: Okay, yeah, thats great, and I think that the fact
theres like a, like for me, just like somebody would take it is great,
but I think a financial incentive from you guys is going to be like to,
I think we have to get this approved, but [we?] will be very happy
about it, so
Buyer: Right, the financial incentive would make people happy.
[Abortion Doctor]: Yeah, exactly.
Buyer: Is that what Im hearing you saying?
[Abortion Doctor]: Yeah, absolutely!
In fact, Planned Parenthoods own job descriptions discuss the need to increase
revenue. The job description for Reproductive Health/Abortion and/or Prenatal Program
Coordinator883 at Planned Parenthood Mar Monte lists under Essential Duties, contribute to
achieving health center productivity goals.884

880

Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform
FNNI0773_20150421063222.
881
Center for Medical Progress, Transcript of Meeting with [PP Doctor #1] at 9-10 (Feb. 6, 2015) (emphasis added),
Exhibit 8.6.
882
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNPB0298_20150421080120.
883
While this position includes delivery of and referring for prenatal care, PPFA performed 18.6 abortions for every
1 prenatal service in 2014. See PPFA Annual Report (2014-2015),
https://www.plannedparenthood.org/files/2114/5089/0863/2014-2015_PPFA_Annual_Report_.pdf.
884
Job description [PPMM-SIP_E&C-000023-000025], Exhibit 8.7.

305

Similarly, at the same affiliate, an Essential Duty of the Health Center Manager is to manage
the health center to meet or exceed goals in productivity, financial performance and client
visits.885
The same duty was seen on many other job descriptions at other affiliates for a variety of
positions. For example, the position of Mid-Level Clinician at Planned Parenthood Los Angeles
included under General Duties, Participate in health center/affiliate efforts to achieve
established revenue cycle goals.886
The position of Medical Assistant III-Specialty Services at Planned Parenthood Pacific
Southwest also said under Essential Functions, Participate in health center/affiliate efforts to
achieve established revenue cycle goals.887
D. PPFA Affiliate Relationship
PPFA invites abortion clinics to become affiliates and thereby join the Federation. The
Panel has learned through interviews with Planned Parenthood executives that affiliates undergo
accreditation by the national office.888 Periodically, a team inspects each affiliate clinic and
reports on any violations they see.889 PPFA requires a wide range of accreditation compliance,
use of internal manuals, and obedience to policy directives designed to ensure compatibility with
PPFA policy. This compliance includes rules and guidelines that address donation of fetal tissue
for research or transplantation. The Panel examined one particular manual titled the PPFA
Manual of Medical Standards and Guidelines (MS&G), which is updated every two years. The
MS&G sets guidelines for affiliate conduct that impacts the transfer of fetal tissue. The Panel
conducted interviews with PPFA executives to better evaluate the implementation of the
guidelines as they apply to the accreditation process at the affiliate clinic level. Affiliated clinics
are subject to accreditation reviews, which are conducted every three or four years.
To qualify for affiliation, clinics must offer the core services as determined by PPFA. The
list of PPFA Core Services includes:

Well Woman Exams, including cervical screening and breast exams

Pregnancy Testing and Options Education
Contraception, Education, Prescribing/Dispensing for all FDA approved methods
STI screening, testing, treatment for women and men
HIV Point of Service Rapid Testing for Women and Men
HPV Vaccine890

885

Job description [PPMM-SIP_E&C-000034-000036], Exhibit 8.8.

Job description [PPLA-SIP_E&C-000093-000095], Exhibit 8.9.
887
Job description [PPPSW-SIP_E&C-000004-000006], Exhibit 8.10.
888
Transcribed Interview of [PP Witness #1] at 25-26 (Oct. 6, 2016), Exhibit 8.11.
889
Id. at 58.
890
U.S. House of Representatives, Committee on Energy & Commerce, Subcommittee on Oversight &
Investigations Follow-Up Questions at 2 (Aug. 20, 2015) [PPFA-HOU_E&C-000163-000164], Exhibit 8.1.
886

306

Additionally, abortion services must be offered in at least one health center per affiliate,
as follows: First Trimester medical abortion; AND/OR First Trimester surgical abortion.891 Each
of these core services involves a financing source, often federal or state taxpayer funding.892
Another aspect of affiliate oversight is performed by the Consortium of Abortion
Providers (CAPS), a unit within the PPFA. [PP Witness #3] told the Panel that CAPS advises
affiliates and supports affiliates that provide abortion services in doing their job better.893 .
[PP Witness #4] told Panel staff, if an affiliate at Planned Parenthood requests technical
assistance, whether that be for clinical services or other, we will provide those technical services
for them. We will consult with them. We will provide onsite assistant.894
PPFA relies upon the 1000-page guidance document, The Medical Standards and
Guidelines (MS&Gs) to regulate affiliate practices and policies. They are the clinical guidelines
that all affiliates follow in terms of core services to provide their care.895 According to [PP
Witness #1] whose duties include oversight of the MS&G, The accreditation team develops a
list of accreditation indicators. They draw those indicators from a variety of documents, one of
which is the Standards and Guidelines, and then they use that when they do their accreditation
visits.896
The Panel sought to understand whether a significant management gap exists between
the PPFA written guidance, specifically the MS&G and the clinical practices of affiliates.
Inadequate compliance with internal management requirements, when they include federal law
and regulation are questions that Congress seeks to have answered in light of the large amount of
federal funding the PPFA receives. The PPFA national office reviews and approves research
projects at the affiliates. [PP Witness #3] told Panel staff, If an affiliate is proposing to initiate
or become involved in a research project, the affiliate presents information about that project to
the National Research Office.897 The relationship between management and affiliates was
further explained as follows:

[PP Witness #1]: An affiliate undergoes accreditation by

the national office . . .898

[PP Witness #1]: If an accreditation team was at an affiliate

doing an accreditation visit and notes there was a violation
of one of the policies, they would make a notation of it,
whatever the policy was.899

891

Id. at 3.
See Chapter II.D.2 supra.
893
Transcribed Interview of [PP Witness #3] at 12 (Nov. 1 2016), Exhibit 8.13.
894
Transcribed Interview of [PP Witness #4] at 11 (Nov. 17 2016), Exhibit 8.14.
895
Transcribed Interview of [PP Witness #3] (Nov. 1, 2016). See above for list of core services, Exhibit 8.13.
896
Transcribed Interview of [PP Witness #1] at 26 (Oct. 6 2016), Exhibit 8.11.
897
Transcribed Interview of [PP Witness #3] at 34 (Nov. 1, 2016), Exhibit 8.15.
898
Transcribed Interview of [PP Witness #1] at 25-26 (Oct. 6, 2016), Exhibit 8.11.
899
Transcribed Interview of [PP Witness #1] at 58 (Oct. 6, 2016), Exhibit 8.12.
892

307

[PP Doctor #1]: IF you are an affiliate you apply to [the]

medical division for permission [to conduct fetal tissue
donation].900

[PP Witness #3]: CAPS advises affiliates and supports

affiliates that provide abortion services in doing their job
better . . . . MS&Gs are the clinical guidelines that all
affiliates follow in terms of core services to provide their
care901

[PP Witness #3]: If an affiliate is proposing to initiate or

become involved in a research project, the affiliate presents
information about that project to the National Research
Office.902

[PP Witness #3]: My main job as Senior Medical Advisor

was the creation of and guidance of a national quality
improvement department. All the affiliates already have
their own quality improvement departments or sorts of
departments like that, but we did not have a unified national
effort, and we now like everybody else use electronic
medical records. . . . We provide quarterly reports to all of
our affiliates on their outcomes. . . .903

[PP Witness #3]: Planned Parenthood has actually always

done research. At the time it was founded there was a branch
of the federal 100 years ago called the Planned Parenthood
Research Bureau that worked on developing new
contraceptives, and so theres a long history of research at
Planned Parenthood, but most recently weve made a
concerted effort to think about as an organization where we
can contribute.904

[PP Witness #3]: In looking back to when I was chair of the

National Medical Committee is when Planned Parenthood
instituted the concept of poor medical services for the first
time, and surveys showed that most affiliates back then did
provide most services, but this was really a way to codify
that womens preventive screening, care for sexually

900

[PP Doctor #1] Briefing with the House Energy and Commerce Committee at 3.b.iii.4.b (Sept. 18, 2015), Exhibit
8.16.
901
Transcribed Interview of [PP Witness #3] at 12 (Nov. 1, 2016), See Exhibit 8.13.
902
Transcribed Interview of [PP Witness #3] at 34 (Nov. 1, 2016), Exhibit 8.15.
903
Transcribed Interview of [PP Witness #3] at 93 (Nov. 1, 2016), Exhibit 8.17.
904
Transcribed Interview of [PP Witness #3] at 95 (Nov. 1, 2016), Exhibit 8.18.

308

transmitted infections. All contraceptive services and

abortion services were tied together in the core mission and
needed to be available to all of our patients.905
The Panel noted that despite these affirmations of a closely managed organization by several of
its key leaders, the Panel found instead a management gap of significant proportions.
E. Planned Parenthood Federation Failure to Ensure Compliance by: Affiliates with Legal
Billing Practices; Federal Law Governing Fetal Tissue Donation Projects; Federally
Required Affirmation about Changing Abortion Procedures; Patient Consent; and
HIPAA Regulations.
1. Summary
The Panel sought to understand even more broadly whether the trajectory of the economic
business culture and compliance control exercised by PPFA influenced clinical practice of its
affiliate clinics. Significant deficiencies described below were revealed by the investigation.
First, the clinics have a checkered history of overbilling Medicaid and of improperly
billing items to cover the costs of abortion services, in violation of the Hyde Amendment.
Second, the clinics did not follow PPFA guidance about compliance with federal criminal
statutes that govern the terms of fetal tissue donation. Accounting documents from middleman
tissue organizations showed that several PPFA affiliates made a profit from the transfer of fetal
tissue.
Third, PPFA failed to secure compliance with the requirement that doctors who perform
abortions certify in writing that the method of abortion has not been changed to facilitate fetal
tissue donation. The PPFA executive in charge of this requirement admitted that she regularly
changed the method of abortion to facilitate intact fetal specimens and further admitted that she
had never certified that the method of abortion was not altered.
Fourth, PPFA guidance on patient consent and the affiliate practice violates federal
consent regulations.
Fifth, the affiliate clinics routinely violated HIPAA privacy regulations to facilitate the
harvesting of fetal tissue for which the clinics were paid on a per specimen basis.
2. Planned Parenthood: Failure to Properly Steward Federal Funds
The Panel sought to understand participation in fetal tissue transfer within the context of
the affiliate clinics general business practices and financial stability. Participation in fetal tissue
donation requires competent accounting and record-keeping practices as well as fiscal precision
in recordkeeping to prevent any possibility of violating the prohibition against profiting from the

905

Transcribed Interview of [PP Witness #3] at 98 (Nov. 1, 2016), Exhibit 8.19.

309

sale of fetal tissue. Thus, the Panel reviewed the history of Planned Parenthoods stewardship of
federal and state funds designated for family planning and other womens health concerns.
This review sought to identify whether the individual clinics maintained accounting
practices that guaranteed the separation of federal funds designated for family planning from
funds that paid for abortion procedures. The Panel found a significant history of flawed and
unlawful management of federal funds by Planned Parenthood.906 Planned Parenthoods
improper practices were revealed primarily through audits performed by the Office of Inspector
General at the U.S. Department of Health and Human Services and by state-level family
planning agencies. Of particular concern is the clinics false designation of abortion services as
family planning services. This practice misallocates federal funds designated for family planning
to underwriting abortion procedures, a violation of the provisions of the Hyde Amendment.
It is difficult to discern exactly how much funding Planned Parenthood receives from the
government. Planned Parenthoods own annual reports over recent years report the following:
FY 2002: $240.9 million907
FY 2003: $254.4 million910
FY 2004: $265.2 million913
FY 2005: $272.7 million916

FY 2007: $336.7 million908

FY 2008: $349.6 million911
FY 2009: $363.2 million914
FY 2010: $487.4 million917

FY 2012: $542.4 million909

FY 2013: $540.6 million912
FY 2014: $528.4 million915
FY 2015: $553.7 million918

During the Panels investigation, it discovered numerous reports about Planned Parenthood. Panel staff met
with personnel from the Office of Inspector General from HHS and reviewed numerous publicly available audits of
Planned Parenthood. During its investigation, research by the Charlotte Lozier Institute and the Alliance Defending
Freedom was provided to the Panel. This section substantially relies upon reporting by the Charlotte Lozier Institute
and the Alliance Defending Freedom.
907
Planned Parenthood Annual Report (2001-2002),
http://prolifeaction.org/wp-content/uploads/docs/pp/PPAnnualReport2001-2002.pdf.
908
Planned Parenthood Annual Report (2006-2007),
http://liveaction.org/research/wp-content/uploads/2011/06/2006-2007-Planned-Parenthood-Annual-Report.pdf.
909
Planned Parenthood Annual Report (2011-2012),
https://www.plannedparenthood.org/files/4913/9620/1413/PPFA_AR_2012_121812_vF.pdf.
910
Planned Parenthood Annual Report (2002-2003),
http://prolifeaction.org/wp-content/uploads/docs/pp/PPAnnualReport2002-2003.pdf.
911
Planned Parenthood Annual Report (2007-2008),
http://www.mdrtl.org/files/PP_AnnualRpt08_vFinal.pdf.
912
Planned Parenthood Annual Report (2012-2013),
https://www.plannedparenthood.org/files/7413/9620/1089/AR-FY13_111213_vF_rev3_ISSUU.pdf.
913
Planned Parenthood Annual Report (2003-2004),
http://www.plannedparenthoodrx.com/annualreport/report-04.pdf.
914
Planned Parenthood Annual Report (2008-2009),
http://www.toomanyaborted.com/wp-content/uploads/2010/PDFs/PP_AR_011011_vF-1.pdf.
915
Planned Parenthood Annual Report (2013-2014),
https://www.plannedparenthood.org/files/6714/1996/2641/20132014_Annual_Report_FINAL_WEB_VERSION.pdf.
916
Planned Parenthood Annual Report (2004-2005)
http://www.stopp.org/PPFAReports/PPFA200405002.pdf.
917
Planned Parenthood Annual Report (2009-2010)
http://liveaction.org/research/wp-content/uploads/2011/06/2009-2010-Planned-Parenthood-Annual-Report.pdf.
918
Planned Parenthood Annual Report (2014-2015)
https://www.plannedparenthood.org/files/2114/5089/0863/2014-2015_PPFA_Annual_Report_.pdf.
906

310

FY 2006: $305.3 million919

FY 2011: $538.5 million920

However, the General Accounting Office reports receipt of only $657.1 million, with
International Planned Parenthood Federation receiving $3.9 million.921 The discrepancy is the
indirect funding the Planned Parenthood receives from Title XIX Medicaid reimbursements. Any
accountability of the individual clinics relies upon the auditing resources of the state and federal
inspector generals.
3. Recent History of Planned Parenthood Audits
There have been 51 external audits of Planned Parenthood affiliates. These audits are
summarized below. Additionally, there have been 61 federal audits of state family planning
agencies. The consistent pattern is the practice of billing of abortion procedures as family planning
or other services such as STD testing. One practice called unbundling or fragmentation
consists of schemes that bill for several types of allowed services to cover the non-allowed costs
of an abortion.
Limited resources and the volume of Medicaid reimbursement billing make it impossible
to audit all federal Medicaid reimbursements. In fact, by design the audits summarized below
reflect a very small sample of the total Medicaid reimbursements received by Planned Parenthood.
For example, during a review of a New York Planned Parenthood affiliate, $11,818,856.30 was
paid for services rendered to 21,413 patients during the audit period. The review itself consisted
of a random sample of 100 patients with Medicaid payments of $53,977.99. The narrow sample
also pales when compared to a GAO estimate that in Fiscal Year 2013 there were $14.4 billion in
improper Medicaid payments.922
Audits of Planned Parenthood Affiliates: Audited Years and Averages923
State

Audited Years Total Overbilling

Overbilling
by Audited Year

California

$5,213,645.92

919

$5,213,645.92

Planned Parenthood Annual Report (2005-2006)

http://liveaction.org/research/wp-content/uploads/2011/06/2005-2006-Planned-Parenthood-Annual-Report.pdf.
920
Planned Parenthood Annual Report (2010-2011)
https://issuu.com/actionfund/docs/ppfa_ar_2011_110112_vf.
921
See U.S. GOVERNMENT ACCOUNTABILITY OFFICE, FEDERAL FUNDS: FISCAL YEARS 2002-2009 OBLIGATIONS,
DISBURSEMENTS, AND EXPENDITURES FOR SELECTED ORGANIZATIONS INVOLVED IN HEALTH-RELATED ACTIVITIES
(GAO-10-533R) (2010), at Table 7, http://www.gao.gov/new.items/d10533r.pdf; see also id. at Tables 10, 16, 18.
922
U.S. GOVERNMENT ACCOUNTABILITY OFFICE, MEDICAID PROGRAM INTEGRITY: INCREASED OVERSIGHT NEEDED
TO ENSURE INTEGRITY OF GROWING MANAGED CARE EXPENDITURES (GAO-14-341) (2014), at 2 (citing a figure
calculated by the Centers for Medicare & Medicaid Services (CMS), the federal agency within the Department of
Health and Human Services (HHS) that oversees Medicaid).
923
Charlotte Lozier & Alliance Defending Freedom, Profit. No Matter What. (Nov. 1. 2016).

311

Connecticut

unknown

$18,791.00

unknown

Illinois

$387,000.00

$193,500.00

Louisiana

$6,147.18

$6,147.18

Louisiana

$0

$0

Maine

5.02

$33,294.83

$6,632.44

Nebraska

0.166

$3537.00

$21,307.23

New York I

unknown

$207,809.00

unknown

New York II

$15,723.91

$15,723.91

New York III

$1,254,603.00

$627,301.50

New York IV

$886.26

$886.26

[New York V

$112,490.31

$37,496.77

[New York VI

$12,031.29

$4,010.43

[New York VII

$11,539.48

$3,846.49

Ohio

unknown

$0

$0

Oklahoma

unknown

unknown

unknown

Oklahoma

unknown

unknown

unknown

Oklahoma

unknown

unknown

unknown

Texas I

unknown

$409,675.10

unknown

Texas II

1.58

$129,028

$81,663

Washington I

unknown

unknown

unknown

Washington II

2.96

$629,142.88

$212,548.27

Washington III

unknown

$11,453

unknown

[Wisconsin I

0.75

$450.39

$600.52

[Wisconsin II

0.75

$1,276.31

$1,701.75

[Wisconsin III

0.75

$135.18

$180.24

312

[Wisconsin IV

0.75

Wisconsin V

$128.28

$171.04

$74.28

$74.28

[Wisconsin VI

$368.51

$184.26

[Wisconsin VII

$467.02

$233.51

[Wisconsin VIII

$381.99

$191.00

[Wisconsin IX

$404.59

$202.30

[Wisconsin X

$2,533.46

$1,266.73

[Wisconsin XI

$277.31

$138.66

[Wisconsin XII

$613.19

$306.60

[Wisconsin XIII

$773.84

$386.92

Wisconsin XIV

$1,864.42

$1,864.42

[Wisconsin XV

$800.00

$266.67

[Wisconsin XVI

$5,139.71

$1,713.24

[Wisconsin XVII

$1,968.71

$656.24

[Wisconsin XVIII 3

$2,096.00

$698.67

[Wisconsin XIX

$13,270.11

$4,423.37

[Wisconsin XX

$468.71

$156.24

[Wisconsin XXI

$2,198.13

$732.71

[Wisconsin XXII

$700.00

$233.33

[Wisconsin XXIII 3

$3,200.00

$1066.67

[Wisconsin XXIV

$1,100.00

$366.67

[Wisconsin XXV

$378.40

$126.13

Wisconsin XXVI

$2,204.26

$2,204.26

Wisconsin XXVII 1

$52,193.24

$52,193.24

$8,552,264.20

$6,497,049.07

TOTAL

83.726
313

4. Summary Details of the Known Audits of Planned Parenthood Affiliates

Approximately one-third of Planned Parenthoods 57 U.S. affiliates924 have been audited.
Each audit typically considers only a small sampling of the total accounting records for a selected
period of time. Thus, a reasonable extrapolation is possible about the audited organizations
financial practices.
l) California Audits
i) California Audit I San Diego and Riverside Counties, 2004
The California Health and Human Services Agency, Department of Health Services
conducted the audit of paid claims to Planned Parenthood San Diego and Riverside Counties
(PPSDRC) from July 1, 2002, to June 30, 2003, for Codes X1500 (contraceptive barrier products)
and X7706 (oral contraceptives), and February 2, 2003, to May 30, 2004 for Code X7722 (Plan B
products).
The audit revealed that (PPSDRC) had received a deep discount from the manufacturer on
certain products and should still be allowed to bill the State of California as though they had paid
a normal wholesale price.
Due to this noncompliance, (PPSDRC) was compelled to repay $5,213,645.92.
ii) California Audit II Golden Gate, 2010
An Internal Revenue Service criminal investigative audit of PPFA affiliate Planned
Parenthood Golden Gate (PPGG) discovered substantial losses for the 2009 tax year and inaccurate
information in the PPGG tax returns.925 PPFA had already conducted an accreditation review of
PPGG in 2004, during which the affiliate failed five of PPFAs nine indicators of financial health.
In a 2010 warning letter, the California Attorney Generals Charitable Trusts Division cited PPGG
Action Fund, PPGGs political advocacy and public policy arm, for failure to file its tax documents
with that office for at least 10 years.926
m) Connecticut Audit
The U.S. HHS-OIG conducted an audit of Planned Parenthood of Connecticut Inc. &
Subsidiar., finding $18,791 in overbilling.927
924

Planned Parenthood website, see Local & State Offices, http://www.plannedparenthood.org/about-us/local-stateoffices.

925
See also Katharine Mieszkowski, IRS Looking into Planned Parenthood Golden Gate After Complaint, THE BAY
CITIZEN, Sept. 2, 2010, https://www.baycitizen.org/news/health/irs-looking-planned-parenthood-after/.
926
See, e.g., Katharine Mieszkowski, Internal Concerns About Fiscal Health and Tax Documents Suggest Long-Term
Disarray, THE BAY CITIZEN, Aug. 12, 2010, https://www.baycitizen.org/news/health/financial-docs-raise-questionsabout/.
927
A-01-99-59104, released Aug. 1999. See U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES OFFICE OF
INSPECTOR GENERAL, SEMIANNUAL REPORT OCTOBER 1, 1999 MARCH 31, 2000 (2000), at D-8,

314

n) Illinois Audit
This audit by the Illinois Department of Healthcare and Family Services Inspector General
of Planned Parenthood of Illinois (PPIL) found 641 missing records, 31 instances of billing for
non-covered services, and 10 instances of billing for services actually performed by someone else,
as well as improper procedure codes. As a result of the audit,928 PPIL and its medical director,
Caroline Hoke, agreed to repay the state $367,000 to settle findings of Medicaid overbilling and
failure to document services allegedly provided, primarily contraceptives.929
o) Louisiana Audits
i) Louisiana Audit I
As the result of an audit conducted by the Louisiana Department of Health and Hospitals
(DHH), one Planned Parenthood clinic repaid $6,147.18 to DHH to settle findings of improper
billings.930
ii) Louisiana Audit II 2014
In response to Louisiana Senate Concurrent Resolution No. 57 and House Resolution No.
105, 2013 Regular Session, Louisianas Legislative Auditor reviewed Planned Parenthood Gulf
Coasts billings during calendar year 2012. In a report issued February 19, 2014, the legislative
auditor found that overall, they could find no evidence that PPGCs billings were not allowable,
and that they had no evidence of PPGC pressuring clients into abortion.931
p) Maine Audit
The Maine Department of Health and Human Services audited Planned Parenthood of
Northern New England (PPNNE), finding that PPNNE billed nearly double its acquisition costs
for Levonorgestrel IUDs. PPNNE agreed to repay the state $33,294.83.932

https://oig.hhs.gov/publications/docs/semiannual/2000/00ssemi.pdf. Charlotte Lozier Institute is working to obtain

full audit records.
928
This audit, case number 1074160, covered the period January 1, 2006, to December 31, 2007.
929
See Andrew L. Wang, Planned Parenthood Settles with Illinois on Medicaid Payments, MODERN HEALTHCARE,
Sept.6,2012,http://www.modernhealthcare.com/article/20120906/
INFO/309069993; Andrew L. Wang, Medicaid Probes Planned Parenthood Fees, CRAINS CHICAGO BUSINESS, July
9,2012http://www.chicagobusiness.com/article/20120707/
ISSUE01/307079977/medicaid-probes-planned-parenthood-fees.
930
Specifically, the clinic had billed clinic services under the laboratory Medicaid provider code and vice versa.
931
However, Louisiana sources report that Planned Parenthood is not currently performing abortions in Louisiana,
making allegations of abortion referrals more difficult to track.
932
See Letter from Herbert F. Downs, Director of Audit, Maine Department of Health and Human Services, to
. (June 21, 2012) (on file with Charlotte Lozier Institute). The
original audit finding was $90,169.27 in overbillings. Letter from Michael Bishop, Auditor II, Program Integrity,

315

q) Nebraska Audit
The Nebraska Auditor of Public Accounts audited Planned Parenthood of the Heartland
(PPH) and other organizations that receive $500,000 or more in federal funds. PPH was found to
have billed and been paid $3,537 for abortion expenses.
r) New York Audits
i) New York Audit I New York City, January 2009
A January 2009 audit of Planned Parenthood of New York City, Inc. (PPNYC)/Margaret
Sanger Center resulted in PPNYC electing to repay the amount of $207,809.00. 933
ii) New York Audit II Hudson Peconic, June 2009
A June 2009 audit of Medicaid payments for family planning and reproductive health
services paid to Planned Parenthood Hudson Peconic, Inc. (PPHP) on behalf of Medicaid
beneficiaries while they were enrolled in Community Choice Health Plan and Health Insurance
Plan of New York found significant overpayments for family planning and reproductive health
services claims, resulting in an overpayment of $15,723.91, inclusive of interest. 934
iii) New York Audit III New York City, June 2009
A June 2009 audit of payments to PPNYC/Margaret Sanger Center for diagnostic and
treatment center services paid by Medicaid found improper practices, with sample overpayments
of $7,960.01 and total overpayments of at least $1,254,603.00. During the audit period,
$11,818,856.30 was paid for services rendered to 21,413 patients. The review consisted of a
random sample of 100 patients with Medicaid payments of $53,977.99. 935
iv) New York Audit IV New York City, December 2009
A December 2009 audit of Medicaid payments for family planning and reproductive
health services paid to PPNYC/Margaret Sanger Center on behalf of Medicaid beneficiaries
while they were enrolled in VidaCare Inc. found overpayments, inclusive of interest, of $886.26.
The audit found that PPNYC had improperly billed Medicaid $719.55 for family
planning and reproductive health services that were rendered to VidaCare enrollees; as a result,
Financial
Services

Audit,
Maine
Department
of
Health
and
Human
Services,
(Dec. 14, 2010).
933
Audit # 08-3045.
934
The audit (Family Planning Chargeback to Managed Care Network Providers, 09-1415, June 10, 2009) covered
the period Jan. 1, 2004, through Dec. 31, 2004.
935
The audit (06-6696) covered the period Jan. 1, 2004, through Dec. 31, 2005.

316

18 NYCRR 515.2 and 540.6 requirements were violated. OMIG then calculated $166.71 in
interest, resulting in $886.26 in required restitution. PPNYC was invited to respond to the draft
report but did not do so within 30 days as directed. 936
v) New York Audits V-VII February/May 2010
Three audits conducted of New York Planned Parenthood affiliates found six categories
of overbilling, resulting in a total overpayment of $136,061.08, inclusive of interest. The audits
found total overpayments of $136,061.08.937
s) Oklahoma Audits
In three apparently separate audits covering the Planned Parenthood affiliates in
Oklahoma, Planned Parenthood of Central Oklahoma, Inc., and Planned Parenthood of the
Heartland, auditors found overbilling rates of 14.1%, 18%, and 20.3%.938
t) Texas Audits
i) Texas Audit I
On June 30, 2009 Planned Parenthood Center of El Paso closed its seven centers for
financial reasons and filed for bankruptcy. The closure led to an audit by Texas Department of
State Health Services (DSHS). The audit revealed numerous example of fiscal mismanagement,
including unpaid subcontractors in the amount of $529,707.97. The OIG determined that PPCEP
was not in compliance with the applicable DSHS contracts since it had requested DSHS
reimbursement for subcontractor billings it had never paid. Subcontractors identified the
outstanding billings as totaling $529,707.97.939
ii) Texas Audit II
The U.S. Department of Health and Human Services, Office of the Inspector General,
released an audit940 of the Texas Health and Human Services Commission that revealed missing
936

The audit (Family Planning Chargeback to Managed Care Network Providers, 09-4845, Dec. 16, 2009) covered
the period Jan. 1, 2005, through Dec. 31, 2005.
937
The audits of PPHP (Prenatal Care Assistance Program, 2009Z33-136W, May 27, 2010), Planned Parenthood of
Nassau County, Inc. (PPNC) (Prenatal Care Assistance Program, 2009Z33-083W, May 27, 2010), and Planned
Parenthood of South Central New York, Inc. (PPSCNY) (Prenatal Care Assistance Program, 2009Z33-048O, Feb. 24,
2010) covered the period Jan. 1, 2006, through Dec. 31, 2008.
938
See Letter from Mary Fallin, Governor, State of Oklahoma, to Nico Gomez, Director, Oklahoma Health Care
Authority Board (Nov. 18, 2015) (on file with Charlotte Lozier Institute); see also, e.g., Kate Richey, What Really
Happened with WIC?, OKLAHOMA POLICY INSTITUTE, Oct. 24, 2012, http://okpolicy.org/what-really-happened-withwic/. Charlotte Lozier Institute is working to obtain full audit records.
939
See Financially Troubled Planned Parenthood of El Paso Closes Doors, LIFESITENEWS.COM, July 1, 2009,
http://www.lifesitenews.com/news/financially-troubled-planned-parenthood-of-el-paso-closes-doors.
940
The audit (Texas Claimed Unallowable Federal Reimbursement for Some Family Planning Services, A-06-1100016) covered the period Mar. 1, 2007, through Sept. 30, 2008.

317

documentation and overbilling of $129,028 ($67,019 from Medicaid and $62,009 from the waiver
program).
u) Washington State Audits
There are three known Washington State audits of Planned Parenthood affiliates. In sum,
they uncovered overpayments of at least $640,595.88, inclusive of interest.
i) Washington Audit I
In 2000 and 2001, an audit of a Planned Parenthood clinic uncovered inflated billings; a
lengthy analysis and negotiation process resulted in an untenable and apparently illicit
agreement.941
ii) Washington Audit II Inland Northwest, 2007-2009
A 2007-2009 audit of the Planned Parenthood of the Inland Northwest (PPINW)
affiliate942 found numerous instances of overbilling or other irregularities, resulting in an
overpayment of $629,142.88, inclusive of interest. 943
iii) Washington Audit III Great Northwest
In May 2012, Planned Parenthood of the Great Northwest (PPGNW) reimbursed the
Medicaid program $11,453 as a result of a sample audit conducted by the Washington Medicaid
Fraud Control Unit (MCFU) as the result of complaints from concerned citizens alleging
questionable billing practices. Additionally, one portion of the audit that related to a particular
type of contraceptive billing was provided to the U.S. Attorneys office for independent
investigation. 944
v) Wisconsin Audits
The State of Wisconsin has released 26 audits it conducted of Planned Parenthood of
Wisconsin from 2006-2012. These 26 audits uncovered total potential overpayments of at least
$43,272.80. Another audit conducted of Planned Parenthood of Wisconsin revealed an additional
$52,193.24 for family planning in 2014. These audits are summarized below:

# 2006 37543 (Milwaukee - West Wisconsin Avenue): $450.39

# 2006 50088 (Kenosha): $1,276.31

941

Email from Myra S. Davis, Medical Assistance Administration Rules and Publications, to Heidi Robbins Brown,
Deputy Assistant Secretary, Medical Assistance Administration, Washington Department of Social and Health
Services (Sept. 17, 2004, 11:56 PDT) (on file with the Alliance Defending Freedom).
942
Doing business as Planned Parenthood of Spokane.
943
The audit (MA 07-13, July 20, 2009) was conducted May 8-10, 2007.
944
Audit # 09-04-08, of Yakima County.

318

# 2006 96759 (Milwaukee - North Jackson Street): $135.18

# 2006 98176 (Milwaukee - North Jackson Street): $128.28
# 2007 03883 (Appleton): $368.51
# 2007 27407 (Madison): $467.02
# 2007 29154 (Sheboygan): $381.99
# 2007 49325 (Waukesha): $404.59
# 2007 66774 (Milwaukee): $2,533.46
# 2007 70591 (Chippewa Falls): $277.31
# 2007 86622 (Fond du Lac): $613.19
# 2007 88039 (Kenosha): $773.84
# 2010 15792 (Madison): $800.00
# 2010 38805 (Milwaukee - West Wisconsin Avenue): $5,139.71
# 2010 55068 (Kenosha): $1,968.71
# 2010 75330 (Beaver Dam): $2,096.00
# 2010 22240 (Racine): $13,270.11
# 2010 34897 (Green Bay): $468.71
# 2010 39809 (Waukesha): $2,198.13
# 2010 40664 (Shewano): $700.00
# 2010 46459 (Chippewa Falls): $3,200.00
# 2010 58443 (Fond du Lac): $1,100.00
# 2010 84963 (Milwaukee - South 7th Street): $378.40

5. Conclusion
There are three important conclusions the Panel reached regarding Planned Parenthoods
stewardship of federal funds. First, local affiliates regularly and with little accountability
substitute billing codes for approved reimbursements for prohibited activities that violate the
prohibition against use of federal funds for abortion services. Second, the affiliates operate with
disregard of accepted accounting procedures. Third, the local affiliates that seek to increase
Medicaid payment through false billing practices also require close scrutiny about compliance
with federal law on receiving valuable consideration for the transfer of fetal tissue.
6.

Compliance with Federal Law Governing Fetal Tissue Donation Programs

As early as April 4, 2001, chief executives of affiliate clinics were directed via written
memorandum by PPFA executives to follow federal regulations for aborted pregnancy donation
programs. The memorandum reminded affiliates that fetal tissue donation is governed by federal
laws:
Fetal tissue donation programs are governed by two federal
laws, the National Organ Transplant Act (42 U.S.C. 274e) (NOTA)
and the NIH Revitalization Act of 1993 (42 U.S.C. 289g-1 and 2)
(NIHRA). These laws, particularly NIHRA, govern many aspects of
fetal tissue donation programs, and the attached Standard addresses
319

all of these issues that affect medical practice and clinical

functions.945
The memorandum warned that:
These laws also forbid the payment or receipt of valuable
consideration for fetal tissue. However, they permit reasonable
payments associated with the transportation, implantation,
processing, preservation, quality control, or storage of fetal tissue.
In addition, NOTA permits reasonable payments for the removal
of fetal tissue when the research is supported by federal funds.
(These laws do not affect a providers ability to charge its normal
and customary fee for the abortion.)946
Affiliates were advised that compliance with the requirements of these laws could be achieved in
one of two ways:
1. One method would be to recover no costs associated with any
aspect of participation in a fetal tissue donation program. This would
mean that all staff time, clinic space, supplies, etc., would be
donated by the affiliate, and the affiliate would receive no payments
or in-kind services from the entity to whom the tissue is being
donated.947
2. The second method would be to employ an independent
auditor to conduct a credible and good-faith analysis of the actual
costs incurred by the affiliate in the transportation, implantation,
processing, preservation, quality control, or storage of the fetal
tissue and, if the research is supported by federal funds, for the
removal of the fetal tissue. Under this method, affiliates must
maintain careful records of actual tissue donations and of payments
received from the researcher or the tissue-gathering entity. Affiliates
must be able to demonstrate that the payments do not exceed the
actual costs of the actual tissue donations.948
Sometimes tissue-gathering entities offer to pay rent for space
occupied by one of their employees who would be on-site at a clinic
on a regular basis. If an affiliate determines to enter into such an
arrangement, then the independent auditor would also conduct a
credible and good-faith computation of the actual cost of the space
945

Email from [PP Witness #1] and [PPFA Executive], (Jan. 26, 2011) containing Memorandum (Apr. 3, 2001).
from [PP Lawyer], [PP executive] and [PP executive], [PPFA-HOU_E&C-000148-000150], Exhibit 8.20.
946
Id.
947
Id.
948
Id.

320

occupied by the tissue-gathering entity employee, in order to

determine the amount of rent to be paid by that entity.949
Affiliates were reminded that the accreditation reviews conducted by PPFA would hold the
affiliates accountable for compliance with the memorandum:
PPFA accreditation reviews will confirm, in the same way as for
any other Medical Standard, that one of these two methods has been
employed by any affiliate that chooses to participate in an aborted
pregnancy tissue donation program.950
Affiliate clinic chief executives were also reminded that they must comply with all state and
local laws regarding fetal tissue programs:
C. Compliance With (sic) State Laws
We remind affiliates that, in addition to the federal laws outlined
above, there are laws in many states governing fetal tissue donation
programs. Affiliates must take great care to assure compliance with
those laws as well.
If you have questions about the federal statutes, feel free to call
[PP Lawyer] at: . . .951
Ten years later, on January 26, 2011, [PP Witness #1] and [PPFA Executive] reissued the
memorandum to Affiliates CEOs, Medical Directors, and Patient Services Directors under
their names as a reminder of the importance of compliance with the MS&G and federal law.
The memorandum formed the basis for two lines of investigation undertaken by the
Panel: (1) the Panel sought to obtain the background accounting documents prepared or relied
upon by affiliates in forming their basis for compliance with the memorandum and federal law;952
and (2) the Panel sought to conduct interviews with PPFA executives about compliance with the
memorandum.
[PP Witness #1] participated in a transcribed interview with the Panel on October 6,
2016. Early in the interview, [PP Witness #1] explained that although her name appears on the
memorandum send line, it was sent not by her, but by a staff member of hers, [PPFA
Executive]. [PP Witness #1] was asked if she supported the memorandums guidance:

949

Id.
Id.
951
Id.
952
See Letter from March T. Bell, Staff Director, House Select Investigative Panel, to K. Lee Blalack II, Esq,
OMelveny & Myers, LLP (Sept. 8, 2016) [hereinafter Blalack letter], Exhibit 8.21.
950

321

[PP Witness #1]: As to what my opinion is, my opinion is that the

affiliates need to follow the guidance that they are provided with.
BY MR. BELL:
Q And that would include, would it not, either getting no
recovery of costs or hiring an auditor, one of those two?
A That is what the guidance says.
Q And you support that guidance?
A That's the PPFA guidance. ThatsI don't know what my
other option is.953
The Panel found no compliance with the requirement that affiliates rely upon an auditor before
entering into a fetal tissue donation program.
7. Planned Parenthood Clinics Profited from the Sale of Fetal Tissue
The Panel initially designed its investigation into the whole of the nations fetal tissue
industry as described in the Investigative Design section above. Later in the year, the Panel
relied upon the confluence of six important factors that caused it to look into the records of
individual Planned Parenthood abortion clinics that chose to participate in fetal tissue donation:

953
954

First, many of the clinics contracted with StemExpress whose marketing materials
offered a profit to clinics who allowed it plug-in tissue procurement program in their
clinics.954

Second, The CMP undercover videos revealed a wink and a nod attitude by PPFA
executives who seemed to communicate that fetal tissue programs help with revenue but
dont get caught because the headlines would be a disaster.

Third, the economic environment of the clinics seemed conducive to measures that would
improve revenue.

Fourth, the Panels hearing on The Pricing of Fetal Tissue, sought the judgment of
seasoned federal prosecutors to compare the federal statute prohibiting profit from fetal
tissue sales with the first tranche of materials from the investigation. Two former U.S.
attorneys and a senior federal litigator agreed that, based on the materials presented to
them, they would open a case against a middleman company. The former prosecutors
also suggested that accounting and bank records would be critical to understanding

Transcribed Interview of [PP Witness #1] at 32 (Oct. 6, 2016).

StemExpress Brochure [NAF 000001-000002-Brochure.pdf], Exhibit 8.22

322

whether there was a violation of federal law. Minority witnesses agreed with this
approach and urged the panel to obtain such records.

Fifth, the production from StemExpress and their bank revealed substantial payments to
Planned Parenthood affiliate clinics.

Sixth, interviews with [StemExpress founder and CEO] revealed that the staff of
StemExpress was performing all the tasks in the Planned Parenthood affiliates clinics
required for procuring fetal tissue.

8. The Panel Investigates Planned Parenthood Affiliate Clinics

PPFA and their affiliate abortion clinics agreed to cooperate voluntarily with the Panels
investigation. PPFA had produced several costs estimates to the House Energy and Commerces
Oversight and Investigations Subcommittee that reported that PP affiliates lost money
participating in fetal tissue donation:
PP Los Angeles$1,065.65 loss on $15,750.00 in fetal tissue revenues;
PP Mar Monte$2,209.32 loss on $18,955.00 in fetal tissue revenue;
PP of Northern California$830.64 loss on $1373.00 fetal tissue revenue;
PP Pacific Southwest$18,670.84 loss on $18,960.00 in fetal tissue revenue955
Thus, the Panel delivered a document request to PPFAs counsel that listed detailed
requests for accounting support documents that formed the basis for the materials produced by
each clinic.956 The Panel sought to rely upon a forensic accounting analysis to verify whether
these cost estimates were reasonable,957 accurate, and whether they were allowable under 42
U.S.C. 289g-2(a) and (e)(3). A complete review of the PPFA production produced an
incomplete picture. First, the cost analysis and revenue materials produced by PPFA were for
2015, a year in which PPFA decided to stop taking payments for fetal tissue. Second, PPFA
produced no background accounting documents to support its cost claims. Third, the Planned
Parenthood affiliate cost claims were on their face ambiguous because they assigned costs to the
Planned Parenthood affiliate that were clearly paid by the contracted middleman tissue company.
Thus, on November 14, 2016, the Panel wrote a further document request to obtain genuine
accounting documents.958
The Planned Parenthood affiliate clinic cost estimates were analyzed under the rubric of
longstanding federal law. On March 10, 1993, the House debated two competing amendments to
H.R. 4, the National Institutes of Health Revitalization Act of 1993. The amendments, one
offered by Rep. Bliley and one by Rep. Waxman, focused on safeguards governing the donation
955

Planned Parenthood Fetal Tissue Expenses Chart, [PPLA-HOU_E&C-0000019, PPMM-HOU_E&C-000002,

PPNC-HOU_E&C-000002, PPPSW-HOU_E&C-000002], Exhibit 8.23.
956
Blalack letter, Exhibit 8.21.
957
Planned Parenthood Fetal Tissue Expenses Chart, Exhibit 8.23.
958
Letter from March T. Bell, Staff Director, House Select Investigative Panel, to K. Lee Blalack II, OMelveny &
Myers, LLP (Nov. 14, 2016), Exhibit 8.24.

323

of fetal tissue for transplantation and for research. The House passed the Waxman Amendment
to H.R. 4, the National Institutes of Health Revitalization Act of 1993. That Amendment includes
the provisions codified as 42 U.S.C. 289g-2(a) and (e)(3):

42 U.S.C. 289g-2(a) states, It shall be unlawful for any person to knowingly

acquire, receive, or otherwise transfer any human fetal tissue for valuable
consideration if the transfer affects interstate commerce.

42 U.S.C. 289g-2(e)(3) adds, The term valuable consideration does not

include reasonable payments associated with the transportation, implantation,
processing, preservation, quality control, or storage of human fetal tissue.

During floor debate, supporters of the Waxman Amendment repeated over and over that
fetal tissue may not be sold.959 Rep. Morella expressed her support for the legislation because
fetal tissue could not be sold.960 Rep. Waxman himself said:
This amendment that I am offering as a substitute would enact the
most important safeguards, and those are the safeguards to prevent
any sale of fetal tissue for any purpose, just not for the purpose of
research. It would be abhorrent to allow for a sale of fetal tissue and
a market to be created for that sale.961
The floor debate corroborates the Committee Report language. The Report from the
Committee on Energy and Commerce stated, Section 498B prohibits the purchase of human
fetal tissue as well as the solicitation or acceptance of directed fetal tissue donations.962 The
Committee prohibition on the sale of fetal tissue is described as making the transfer of fetal
tissue parallel with donation of other organs under the Organ Procurement and Transplantation
Act.963 The Committee Report adds, however, Indeed the Committee has dealt with fetal tissue
more restrictively . . . . 964 The Committee intent is to disallow payment for procurement of any
organs.
The intent of the statute is best understood through a simple contrast between two modes
of transferring fetal tissue from one entity to another. With the first, an abortion clinic or
middleman procurement business transfers tissue to a researcher, and the researcher may
reimburse the abortion clinic or procurement business for its reasonable costs incurred by the
transportation, processing, preservation, and quality control of the tissue. With the second, the
payment from the researcher exceeds those reasonable costs, enabling the abortion clinic or
procurement business to make a profit and thus violate the statute.
959

139 Cong. Rec. H1099 (1993) (statement of Rep. John Edward Porter in support of the Waxman Amendment).
139 Cong. Rec. H1099 (1993) (statement of Rep. Connie Morella in support of H.R. 4 and the Waxman
Amendment).
961
139 Cong. Rec. H1099 (1993) (statement of Rep. Henry Waxman).
962
H.R. Rep. No. 103-28 at 76 (1993).
963
Pub. L. No. 98-507, 98 Stat. 2339 (1984).
964
H.R. Rep. No. 103-28 at 76 (1993).
960

324

Not a violation of 289g-2

Payment

Costs

Zero

Violation of 289g-2

Payment

Costs

Profit

The congressional intent of the Waxman Amendment served as a guide for the Panels
investigative plan of the Planned Parenthood affiliate clinics. The core question became the
following: If fetal tissue is transferred from one entity to another, does the transfer violate the
intent of 289g-2? To answer this question, the panel identified four business models currently
operating in the market sector and one operating in the public sector. The Middleman Model
comprises a middleman tissue procurer who obtains tissue directly from a source such as a PPFA
affiliate clinic and then transfers the tissue to a customer, usually a university researcher.
The Panel started its inquiry into the middleman or tissue broker model, the primary
business model for the transfer of human fetal tissue. The statute raises several fundamental
questions about this model as displayed by the graphic below.

325

Middleman
Procurement
Business

Abortion Clinic
(1) Receives
payment for fetal
tissue. How
much?

$$$
(2) Reasonable
costs? How
much?

(1) Pays Abortion

clinic for fetal
tissue? How
much?
(2) Receives
payment from
researcher? How
much?
(3) Reasonable
costs? How much?

326

Researcher
Pays Procurement
Business for fetal
tissue? How
much?

$$$

The middleman investigation, and in particular the investigation of StemExpress,

produced information about several PPFA affiliate clinics.965 In particular, it became clear that
StemExpress was doing all the work to obtain consent for donation from individual patients, that
StemExpress was doing the work of harvesting the fetal tissue after an abortion was complete,
and that StemExpress was doing the work and passing on its costs of shipping to customers. This
raised a profound issue for the Panel: Both the middleman and the PPFA affiliate clinic were
claiming the same expenses against their revenue to show a loss on fetal tissue sales.
9. PPFA Affiliates and StemExpress Claim the Same Expenses
Attorneys for StemExpress created several cost estimates that purport to show that
StemExpress loses money each time it procures a fetal tissue sample and ships it to a customer.
These are graphically summarized in the column with orange numbers in the chart below.
COMPARISON OF STEMEXPRESS COST ANALYSIS WITH GENERALLY
ACCEPTED INDUSTRY STANDARDS FOR ONE UNIT OF FETAL TISSUE IN 2013
COST ITEMS AND ESTIMATE PRODUCED BY STEMEXPRESS
ADJUSTED BASED ON REASONABLE INDUSTRY STANDARDS
COSTS ALLOCATED TO MATERNAL BLOOD ESTIMATED AT 50%
Cost Item

Description

Estimated
Time

Estimated
Cost/Expense

Recalculated
Time

Recalculated
Cost/
Expenses

Costs
for
Maternal
Blood

Procurement
Management
Labor

Receive and evaluate purchase

order, enter into Computer
system and task board, assign
to clinics.

1 hour x
$35

$25.00

.5 hour x $35

$12.50

$ 6.25

Packaging
Supplies Labor

Packaging all supplies needed

for procurement.

1 hour x
$10

$10.00

.5 hour x $10

$5.00

$2.50

Shipping

Supplies to Clinic

N/A

$15.00

$15.00

$7.00

Mileage

Mileage paid to technician

(.56/mile)

N/A

$75.00

$75.00

$35.00

Supply cost

Box, conical tube, media, petri

dish, labels, biohazard bag, gel
packs, etc.

N/A

$30.00

$30.00

$15.00

965

See Chapter V.A supra.

327

Technician Base
Labor

Patient consent, procurement,

paperwork packaging.

8 hour x
$10

$80.00

Technician
Supplemental
Compensation

Technician Supplemental
Compensation

N/A

Clinic
Reimbursement

Technician space, storage of

supplies, blood draw chair
usage, consent space

Infectious Disease
Draw

$10.00

$5.00

$30.00

$0.00

$0.00

N/A

$55.00

$55.00

$27.50

Supplies: tubes, labels, needle,

biohazard bag, etc.

N/A

$15.00

$15.00

$7.50

Infectious Disease
Screening

Screening for HIV, HepB,

HepC, LCMV

N/A

$70.00

$70.00

$35.00

Shipping

Average Shipment cost to the

Lab (blood and/or tissue)

N/A

$20.00

$20.00

$10.00

Procurement
Management
Labor

Review paperwork,
communications with courier,
communications with
researcher

1 hour x
$35

$35.00

$35.00

$5.00

Product Receipt

Receipt of product at front

desk, check into Sage, check
into log

1 hour x
$15

$15.00

.25 hour x
$15

$4.00

$2.00

Inventory &
Supply
Management

Prorated stores management

1 hour x
$20

$20.00

.25 hour x
$20

$5.00

$2.50

$351.50

175.75

$495.00

1 hour x $10

Shown in orange, the cost estimates produced by the attorneys are inconsistent with
accounting records produced by StemExpress itself. For example, StemExpress lists clinic
reimbursement defined as Technician space, storage of supplies, blood draw chair usage,
consent space which the Panel found was not an actual payment made by StemExpress to the
clinics. Also, the costs associated with shipping and infectious disease are passed on to the
customer and thus are not a cost to StemExpress. Finally, management labor costs at one hour
per item ordered, which are counted twice, are dramatically inconsistent with the number of
orders actually handled by StemExpress. Similarly, StemExpress estimates do not allocate any
costs (such as mileage) to maternal blood which is harvested at the abortion clinic at the same
time the human fetal tissue is harvested.

328

StemExpress has consistently refused to produce subpoenaed accounting documents that

the Panel requires to complete its analysis. In the summary below, StemExpress claimed as
expenses various items that were reimbursed by customers. Our forensic accounting analysis
revealed that if these reimbursements were accounted for, they would yield a profit to
StemExpress.

Sample review of a sale of maternal blood to

customer Baylor per invoice #1940 of
1/12/2013
Sale price for Tissue $250.00
Disease screening charged to client $125.00
Shipping charged to client $85.00
Total Revenue obtained from this sale
$460.00
Estimated cost of Tissue (per above) $175.75
Excess of revenue over cost $217.00

Sample review of a sale of fetal tissue to

customer Baylor per invoice #1940 of 1/12/2013
Sale price for Tissue $250.00
Disease screening charged to client $125.00
Shipping charged to client $85.00
Total Revenue obtained from this sale $460.00
Estimated cost of Tissue (per above) $351.00
Excess of revenue over cost $108.50

329

StemExpress and other productions reveal that the payments to Planned Parenthood
affiliates are for each item of fetal tissue.966 The graphic below summarizes the known payments
to various Planned Parenthood clinics for fetal tissue.
Procurement Planned
Business
Parenthood
Clinic
ABR

Stem
Express

Novogenix

2010

2011

2012

2013

2014

2015

Total

First Avenue

52,075

36,000

20,400

18,600

18,240

145,315

Mar Monte

5,390

5,390

Riverside

16,020

21,660

36,720

33,540

31,740

23,460

163,140

Pacific
Southwest

18,960

18,960

San Diego

13,080

13,080

San Jose

5,500

5,500

Mar Monte

2,910

48,388

74,625

40,220

40,630

18,955

225,728

Shasta
Pacific

2,520

8,340

8,690

1,375

20,925

Los Angeles

15,750

15,750

81,895

106,048

134,265

100,700

99,300

91,580

613,788

10. Planned Parenthood Production Schedule of their Costs Associated with Fetal Tissue
Donation
Deductions from the revenue summarized above were described in Planned Parenthood
affiliates cost estimates produced to the House Committee on Energy and Commerce to each
show a net loss resulting from their participation in fetal tissue donation for research. Section
289g-2 makes certain costs associated with fetal tissue allowable as a deduction from and

966

See StemExpress contracts with PP Mar Monte, PP Shasta Pacific and PP Santa Barbara, [Stem.House.OGR_000001-6 and 000015-17/Stem.House.Select_0167-172 and 0181-0183], Exhibit 8.25.

330

valuable consideration received for the tissue. The Panel sought to investigate and analyze these
costs from several perspectives:
1) Did the affiliate rely upon an auditor to create a framework for allowing costs?
2) Did PPFA executives take seriously the statutes requirement that profiting from the
sale of fetal tissue is a Section 289g-2 violation?
3) Did any middleman organization provide services to the affiliate or claim expenses
that would disqualify costs claimed by the affiliate?
4) Are the affiliate-listed costs allowable under the limitations of Section 289g-2?
5) Did the affiliate include job descriptions of its employees for which it listed costs?
Costs Listed by Planned Parenthood Affiliates
Four affiliates provided schedules listing cost and revenue for a one-year time period (FY
2015). These schedules are listed below.967
Planned Parenthood Los Angeles
Listed costs:

$16,815.65

Reimbursements:

$15,750.00

Net Loss:

($1,065.65)

Planned Parenthood Mar Monte

Listed costs:

$21,245.32

Reimbursements:

$18,955.00

Net Loss:

($2,209.32)

Planned Parenthood Northern California

967

Listed costs:

$16,815.65

Reimbursements:

$15,750.00

Net Loss:

($830.64)

Planned Parenthood Fetal Tissue Expenses Chart, Exhibit 8.23.

331

Planned Parenthood Pacific Southwest

Listed costs:

$16,815.65

Reimbursements:

$15,750.00

Net Loss:

($18,670.84)

11. The Planned Parenthood Cost Documents Are Unsupported

In the transmittal letter to the Committee on Energy and Commerce dated November 10,
2015, that included the PPFA affiliate fetal tissue cost estimates, the Counsel for PPFA explains that
these are estimates only:

The affiliates have each performed a good-faith accounting of

their costs associated with facilitating fetal tissue donation, and have
demonstrated conclusively that those costs exceeded the payments
they received. Your September 30 Letters separately request that the
affiliates provide to the Committee all audits conducted of the fetal
tissue donation programs, along with documents, such as calculation
sheets and budgets, relating to the reimbursements they received.
We have determined that these four affiliates either did not conduct
or cannot locate contemporaneous cost analyses, or secure
independent audit opinions as articulated by PPFAs then-existing
guidance.968
This representation is consistent with the non-production of such documents requested a
year later by the Panel. In fact, the Planned Parenthood affiliate costs requests are riddled with
flaws. And they are inconsistent with the statements of PPFAs own employees. In an interview
with [PP Doctor #1],969 Committee on Energy and Commerce staff asked her about the history of
contracting with Novogenix, a tissue procurement middleman. The memorandum described
above in Section 5 was in effect at the time, so the staff wanted to know whether an auditor was
consulted when evaluating the per specimen payment from Novogenix:
In 2010understanding was she received in and was aware of it [the
MS&G] floating around in head, with updates; recall consulted
protocol in 2010-did not use independent auditor, did informal
rough calculation of cost.970
The Panel interviewed [PP Witness #2] on October 19, 2016. The interview focused on a
contractual arrangement between Planned Parenthood Gulf Coast and the University of Texas
Medical Branch which called for the Planned Parenthood affiliate to provide fetal tissue to the
Letter from K. Lee Blalack II, OMelveny & Myers LLP, to the Hon. Fred Upton, the Hon. Timothy Murphy,
and the Hon. Joseph Pitts (November 10, 2015) at 3, Exhibit 8.26.
969
[PP Doctor #1] Briefing (Sept. 18, 2015), Exhibit 8.16.
970
Id. at 4 (emphasis added).
968

332

medical school. [PP Witness #2] was asked how she arrived at the costs related to how much to
charge the medical school:
Q

Have you seen this agreement ever before?

I have.

Q
And is this the type of thing that you would participate in
the development of?
A

I have.

Q
Okay. So the questionone of the questions that we have
is, when you decided staff time for consent [$]50, sterile [$]100, did
you dohow did you come up with those numbers?
A
They were basically back-of-the-envelope-type
calculations involving the time it takes staff to conduct those
procedures relative to the study.971
[PP Witness #1] also was asked a series of questions about StemExpress making a profit
in its contractual collaboration with PP affiliates. The questions were focused on the markup of
an intact fetal brain from $55 paid to the Planned Parenthood affiliate versus the $3,340 charged
to the customer:
Q Three thousand three hundred and forty. Now, thatthat
particular brain is shippedis shipped out of the clinic.
Now, heres the scenario, and well be done. Tissue tech learns
whos available for contributing. She goes and gets the consent. She
gets paid a bonus. The Planned Parenthood clinic, I believe, gets
$55, but its in the range of [$]30 to [$]100, and StemExpress resells
that brain for over $3,000.
And you'll noticeyou may notice on there [the invoice] that
the shipping and maybe some other things are paid for by the
customer.
Now, does that bother you?
A No.
Q Okay. So if StemExpress made a profit by marking up what
they paid for the tissue 2,800 percent, would that bother you?
A I dont know that theyre ma[r]king [sic] it up. I have no
idea what their costs are.
971

Transcribed Interview of [PP Witness #2] at 26-27 (Oct. 19, 2016) (emphasis added), Exhibit 8.27.

333

Q Well, if theyif it was a profit would it bother you?

A Its really none of my business, no.
Q Its not your business what StemExpress does, but how is not
your business when StemExpress does this work inside of Planned
Parenthood Federation clinic?
They offer a profitable situation of the clinic. They get the
consent. They get the tissue, and they resell it, and youre in a
contractual relationship with them. Theyre a vendor of Planned
Parenthood. If it was a profit of 2,800 percent, would that raise a red
flag for you as an organization? . . .
Mr. Bell. What Im trying to understand, counsel, is the
management mindset of a senior manager at Planned Parenthood
who may or may not have seen this error before today and may or
may not have known how the consent works or how the tissue tech
is paid or what StemExpress marks up the tissue for.
Im saying as the senior manager of Planned Parenthood that
oversees her scope of work, is it a concernso when theyre in a
contractual relationshipis making what looks like a huge profit on
selling fetal tissue.
[PP Witness #1]. So the first thing that I want to just correct is
you said that they were offering a profitable service or something to
our affiliates, which theyre not. Our affiliates dont make a profit
on tissue donation.
Mr. Bell. But I just
[PP Witness #1] I just wanted to correct that statement.
Mr. Bell. I think youre right to correct that. My concern, my
question to you, Doctor, is not to reach a factual conclusion. Youre
one of the top people in this organization. What I want to learn is
are you concerned when an organization comes to your organization
and offers a profit to them, which seems to violate the guidance in
the legal memo that we read earlier.
BY MR. BELL:
Q Is that a concern to you?
They come in and say, I know you're not supposed to make
a profit, but partner with us because itll be profitable.. . .
334

Mr. Bell. And heres a more granular example. It looks like

StemExpress, who for several years only did abortion clinics, now
they do lots of stuff, lots of other stuff. But for several years of their
life they only got tissue from Mar Monte, Shasta Pacific, and resold
it at prices like this.
And I just want to know whats sort of the global management
perspective of a Planned Parenthood senior leader like you if thats
a 2,800 percent profit.
BY MR. BELL:
Q Would that bother you?
A So just so that Im clear on the question youre asking me if
it bothers me that StemExpress makes money reselling the tissue?
Q Yeah.
A Its none of my concern. It doesnt bother me.972
In an undercover video, [PP Witness #4] told journalists that [PP Lawyer], of PPFAs
legal department, had warned them about the federal laws surrounding fetal tissue donation:
Buyer: Yeah. And as far as the specifics of remuneration, is there
any guidance from [PP Lawyer] other than how tobecause one
thing weve talked about with [PP Witness #1] before is just to make
sure thats kind of back-ended in the right way so that its a
reasonable covering
[PP Witness #4]: Yes he gave very clear instructions, that the federal
law says you cannot be remunerated for tissue, what you can be
remunerated for is costs of collection. So if theres admin costs,
extra staff time, transport fees, materials or supplies, you just need
to really document what those are, and say, you know, This is $100
worth of whatever, or $50 worth of, admin time, materials that its
costing us. So that if somebody comes in and says, Youre
collecting money for tissue, well say, No were not, were
collecting money for administrative costs. So he gave them 4 or 5
things that they should consider. So he was very clear about that.973

972
973

Transcribed Interview of [PP Witness #1] at 156-59 (Oct. 6, 2016), Exhibit 8.28.
Center for Medical Progress, Transcript of Meeting with [PP Witness #4] at 16 (March 18, 2015), Exhibit 8.29.

335

12. Comparison of Costs Claimed by Planned Parenthood Affiliates and Expenses Claimed
by Fetal Tissue Middleman StemExpress
The Panel took note of both StemExpress and the Planned Parenthood clinics listing the
same expenses as costs against their revenue for fetal tissue transfers. In StemExpress case, they
list costs paid by the customer, but both StemExpress and Planned Parenthood list the same costs
in their production to the Panel. This comparison is described in the graphic chart below.

StemExpress vs. Planned Parenthood

Cost Deduction Chart974
Claimed By
Cost Type

Planned Parenthood

StemExpress

Supplies

(Mar Monte) Y

Supplies/Equipment for
tissue collection and consent
vs. Supplies to clinics and
supply costs

Consent

(Mar Monte) Y

Staff time interpreting

verifying and
signingscanning consent
forms vs. patient consent,
and consent space

Handling supplies

(Mar Monte) Y

Staff Time cleaning Stem

Express Equipment vs.
Storage of supplies

Shipping supplies

(Mar Monte) Y

Shipping labels vs. packaging

all supplies needed for
procurement and Shipment
to lab

Work space

(Mar Monte) Y

Use of Space by StemExpress

Representatives vs.
technician space and
consent space

974

Comments: PP vs. SE

Planned Parenthood Mar Monte and Shasta Pacific Fetal Tissue Costs [PPMM-HOU_E&C-000001-02, PPNCHOU_E&C-000001-2], Exhibit 8.23.

336

Consent

(Shasta-Diablo) Y

Costs associated with

obtaining patient
consentStaff time verifying
and signingscanning consent
forms vs. patient consent,
and consent space.

Tech Transportation

(Shasta-Diablo) Y

Costs associated with

transportation...tubing for
Sterile Instrument
Transportation vs. packaging
all supplies needed for
procurement and Shipment
to lab

Tissue screening

(Shasta-Diablo) Y

Staff Time screening donated

tissue vs. Screening for HIV,
HepB, HepC, LCMV

Work Space

(Shasta-Diablo) Y

Use of Space by StemExpress

Representatives: Dedicated
work areas and Storage areas
vs. technician space and
consent space

The chart above illustrates how two Planned Parenthood clinics and a middleman
company, StemExpress, both claimed expenses for the same costs. This double counting found
by the Panels forensic accounting analysis raised serious doubts about whether the affiliates
estimates were anything more the back of the envelope guesses. The timing of the creation
also raises the question whether the cost estimates were created for public advocacy purposes.
13. Planned Parenthood Affiliates Cost Schedules Compared to the Defined Allowable
Costs in 42 U.S.C. 289g-2
The Panel noted that the language describing allowable costs under Section 289g-2 are
costs associated with activities that are downstream from the tissue procurement process that
takes place inside an abortion clinic with the exception of transportation. In virtually every
example examined by the Panel, transportation was a cost passed on to the end user or
customer, usually a university researcher.
337

Since Section 289g was passed by Congress at a time when the state of
biomedical research anticipated that fetal tissue would be transplanted into human
subjects, the statute allows costs associated with implantation. Since
implantation does not occur at the abortion clinic level, it is unreasonable that any
costs counted against payments for fetal tissue could be claimed by either a clinic
or by a middleman tissue procurer.

Processing of fetal tissue occurs in two places: (1) some middleman companies
process fetal tissue into concentrated cell lines for specific research applications
or the end user processes the tissue into a cell line or other research tool such as a
humanized mouse. Thus, processing by definition cannot take place at the
Planned Parenthood affiliate clinic.

Preservation refers to one of several methods whereby recently harvested fetal

tissue is stabilized so the cell properties will not deteriorate. This could be
immediate refrigeration (possible cost to an affiliate clinic), placing the tissue in a
serum such as a bovine calf serum for stabilization and shipment, or simply
placing the tissue in packaging with an ice pack for shipping. Other preservation
would be undertaken by the end user at the time of receipt.

Quality control is similarly not the province of the abortion clinic. The remains of
an unborn child are caught in a nominally sterile pan. A tissue technician sorts
through the remains and harvests the tissue for which she has customer orders. In
virtually all cases, the tissue is packaged immediately for shipping. This work is
usually performed in a clinic pathology lab which exists to make sure all body
parts are removed from the mothers uterus and then the remains are stored for
disposal. There is no quality control performed by the abortion clinic at this point
in the fetal tissue procurement process. Quality control refers instead to the
downstream effort by the researcher to assure the purity and integrity of their
specimen, anticipated at the time of passage of 289g to be transplant into a
human subject.

Storage is a possible cost to an affiliate clinic if it allowed harvested tissue or

partial baby cadavers to be stored by refrigeration. No Planned Parenthood clinic
reported that it acquired additional refrigeration capacity as a result of
participation in a fetal tissue donation project.

The locus of most storage costs would be again by the downstream end user, a researcher who
may store a cell concentration or even frozen fetal tissue for months or years.
The chart below reveals that the claimed cost schedules produced by Planned Parenthood
actually attempt to allocate costs to the clinics that are more properly assigned to the middleman
procurer or the end user researcher.

338

Planned Parenthood Costs Compared to Allowable Reimbursements

Under 42 U.S.C. 289g-2
Planned
Parenthood
Affiliates
Claimed Costs

Transportation

Implantation

Processing

Preservation

Quality
Control

Storage

Planned
Parenthood
Mar
Monte/SE
Staff Time
Coordinating
and Managing
Patient Flow

NO

NO

NO

NO

NO

NO

Staff Time
Supervising /
Coordinating
with Stem
Express
Representative

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Interpreting
Consent Forms

NO

NO

NO

NO

NO

NO

Staff Time
Verifying and

NO

NO

NO

NO

NO

NO

339

Signing
Consent Forms
Staff Time
Scanning
Consent Forms

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Cleaning Stem
Express
Equipment

NO

NO

NO

NO

NO

NO

Staff Time
Invoicing Stem
Express

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Use of Space
by Stem
Express
Representatives

NO

NO

NO

POSSIBLY NO

NO

340

Staff Time
Supervising /
Coordinating
with Stem
Express
Representative

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Verifying and
Signing
Consent Forms

NO

NO

NO

NO

NO

NO

Staff Time
Scanning
Consent Forms

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Coordinating
Courier Service
for Stem

POSSIBLY

NO

NO

NO

NO

NO

Planned
Parenthood
Shasta Pacific

341

Express
Representative
Staff Time
Screening
Donated Tissue

POSSIBLY

NO

NO

NO

NO

NO

Staff Time
Invoicing Stem
Express and
Coordinating
Program

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Operations
Costs

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Use of Space
by Stem
Express
Representatives

NO

NO

NO

POSSIBLY NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

Planned
Parenthood
Mar
Monte/ABR
Staff Time
Communicatin
g with ABR

342

Representative
Prior to
Collection
Staff Time
Supervising /
Coordinating
with ABR
Representative

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Discussing
Program with
Patients,
Obtaining
Consent or
Declination

NO

NO

NO

NO

NO

NO

Staff Time
Preparing
Consent Forms,
Whiteboard,
and
Anonymized
Consent List

NO

NO

NO

NO

NO

NO

Staff Time
Sending
Consent Forms
to
Administrative
Office

NO

NO

NO

NO

NO

NO

343

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Extra Tissue
Examination
Time

POSSIBLY

NO

NO

NO

NO

NO

Staff Time
Transferring
Tissue to ABR
Representative

NO

NO

NO

NO

NO

NO

Staff Time
Managing
Deliveries,
Moving Boxes,
& Discarding
Documents for
ABR
Representative

POSSIBLY

NO

NO

NO

NO

NO

Staff Time
Coordinating
Courier Service
for ABR
Representative

POSSIBLY

NO

NO

NO

NO

NO

Staff Time
Invoicing ABR
Reimbursement

NO

NO

NO

NO

NO

NO

Staff Time
Installing Shelf
for ABR
Representative

NO

NO

NO

NO

NO

NO

344

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

General
Administrative
Overhead

NO

NO

NO

NO

NO

NO

Use of Space
by ABR
Representatives

NO

NO

NO

NO

NO

NO

General
Administrative
& Medical
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Preparing
Surgical List
and Internal
Coordination

NO

NO

NO

NO

NO

NO

Staff Time
Coordinating
with
Novogenix
Representative

NO

NO

NO

NO

NO

NO

Staff Time
Attending
Morning
Meetings
Discussion of
Donation
Program

NO

NO

NO

NO

NO

NO

Staff Time
Managing and

NO

NO

NO

NO

NO

NO

Planned
Parenthood
Los Angeles

345

Overseeing
Tissue
Donation
Program
Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Management &
General
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Discussing
Program with
Patients,
Obtaining
Consent or
Declination

NO

NO

NO

NO

NO

NO

Staff Time
Preparing,
Processing, and
Photocopying
Consent Forms

NO

NO

NO

NO

NO

NO

Supplies /
Equipment

NO

NO

NO

NO

NO

NO

Management &
General
Overhead

NO

NO

NO

NO

NO

NO

Staff Time
Transferring
Tissue to
Novogenix
Representative

POSSIBLY

NO

NO

NO

NO

NO

346

Staff Time
Disposing of
Unused Tissue

NO

NO

NO

NO

NO

NO

Staff Time
Coordinating
with
Novogenix
Representative

NO

NO

NO

NO

NO

NO

Staff Time
Invoicing
Novogenix
Reimbursement

NO

NO

NO

NO

NO

NO

Staff Time
Revising
Electronic
Health Records

NO

NO

NO

NO

NO

NO

Management &
General
Overhead

NO

NO

NO

NO

NO

NO

Use of Space
by Novogenix
Representatives

NO

NO

NO

POSSIBLY NO

NO

Management &
General
Overhead

NO

NO

NO

NO

NO

347

NO

14. Job Descriptions of Planned Parenthood Staff do not Include any Reference to Tasks or
Responsibilities Associated with Fetal Tissue
After reviewing the cost schedules of Planned Parenthood affiliates, the Panel requested
and obtained job descriptions from the counsel representing the entities. The Panel sought to
determine whether job descriptions or job announcements included any reference to tasks related
to fetal tissue donation. The Panel similarly sought any information that the affiliates
participation in fetal tissue donation required the hiring of new staff. The Planned Parenthood
affiliates produced no evidence to support either job description adjustments or hiring of new
employees due to the tasks involved in any aspect of fetal tissue donation. The chart below
summarizes the job descriptions of the employees at the affiliates.
Review of Staff Time Claimed by Planned Parenthood as Part of Costs Associated with
Collecting and Processing Fetal Tissue as Compared to Job Descriptions of Staff

Does Not Include

Staff Title

Includes Fetal
Tissue

Planned Parenthood Mar Monte:

Health Services Specialist: Provides direct service in all
health centers, provides clients with accurate info
regarding PP services, screens patient history, etc.
Abortion Coordinator: Scheduling, notify patients of
follow-ups, provide medical record transfers, serve as
liaison between PPMM and outside lab to follow-upon
concerns with results interpretation and transmission.
Center Manager: Responsible for the day-to day
management of all health center activities.
Chief Medical Officer: Oversee maintenance of medical
records, credentialing of staff, hire and supervise senior
staff, represent PPMM on managed care plan committees,
and local, state, and national task forces, committees and
Boards.
Clinician: Review and interpret medical/social history of
patients, perform screening procedures/exams, interpret lab
348

Fetal Tissue

data, provide contraceptive methods, provide non-surgical

abortion, act as medical consultant to clinic staff.
Check-Out Specialist: Posts charges to and ensures
accuracy of Electronic Practice Management system, sends
CDS to billing department, handles patient check-out,
calculates and collects fees, solicits contributions,
schedules future appointments.
Assistant Lab Manager: Match specimens to requisitions,
prepare specimens for testing, notify clinics of positive
results, perform/supervise laboratory testing in compliance
with appropriate policies/guidelines.
Accountant: Conduct analysis as needed for the purpose
of verifying appropriate allocation of Accounts Payable
duties, responsible for completeness and accuracy of
Accounts Payable vouchers, review and reconcile vendor
statements to include analyzing charges and payments.
Verify and maintain all rental, lease, and contract accounts.

Registered Nurse: Provide care for patients under

established Medical Protocols, perform various medical
procedures, administer medication, assess status of
patients.
Center Manager: Ensuring efficient coordination,
management of workflow, efficient implementation of new
services, and management of health center staff resources
for services provided. Assure medical centers compliance
with agencys state and federal regulations. Oversight of
supervisory responsibilities in accordance with policies and
applicable laws.
Medical Assistant: Responsible for all supporting
functions in the delivery of reproductive health care
services. Assist patients by providing testing, screening,
349

and education required for the provision of medical

productive health care.
Clinician: Provide quality patient care including exam,
diagnosis, treatment, education and counseling for clients
in accordance with agency protocols.

Surgical Technician: Member of an operating room team

during surgical and endoscopic procedures. Serves as a
scrub technician in an operating room and provides direct
and indirect care to patients before, during, and after
surgery.
Medical Director: Responsible for ensuring provision,
coordination and oversight of medical services. Assumes
responsibility for training, supervisor and evaluation of all
clinicians in concert with medical Management
Leadership.
Vice President of Patient Services: Ensures the
continuing provision of high quality services to all patients.
Oversees laboratory services, research and training
program teams and clinical compliance and risk
management.
Administrative Assistant for Patient Services: Provides
secretarial and administrative support to the Vice
President, Patient Services, Medical director, and others in
the Patient Services department.

Vice President of Medical Services: Responsible for the

overall development, management, and supervision of
clinic staff and services. Collaborates with other
departments to provide community services. Responsible
for center planning and fiscal management.

350

Center Director: Direct oversight for the overall

development, management, and supervision of center staff
and services. Monitor client volume, capacity and
productivity. Provide direct patient care approx. 10-20% of
the time. Plan and implement new programs and services
as needed.
Abortion Services Coordinator: Assist with management
of abortion services, assist Center Director with
compliance to protocols and licensing standards, program
management including audits, statistical reports, medical
follow-up and maintenance of manuals.
Medical Director: proposes recommendations on medical
policies, reviews all medical protocols, serves as the
Director of Abortion, Ultrasound, Sedation, and
Colposcopy Services.

Medical Services Manager: Works with VP of Medical

Services and other staff in development of systems,
processes, and forms to enhance efficiency at the centers,
manages the proficiency testing program, manages the
surgical and medication abortion reporting systems,
responsible for the abortion complication reports and
colposcopy correlation data systems.
Planned Parenthood Pacific Southwest:
Front Desk: Responsible for greeting and checking-in
clients, preparing, scanning and coordinating paperwork,
determining payer source, collecting fees/receipts and
donations, collecting IDs, answering phones, scheduling.
Center Manager: Manage and oversee the provision and
delivery of efficient center operations and client services in
a specialty services (abortion, permanent birth control,
colpo/LEEP) setting, as prescribed by the Agencys
protocols, policies, and procedures.

351

Flow Coordinator: Develop and maintain a system for

optimal center flow. Monitor/minimize wait times and
patient/staff schedules, ensure clinicians maximize
productivity by arranging patient charts to keep all rooms
filled.
Medical Assistant: Obtain medical history, interview and
educate clients ensuring informed consent, perform options
and abortion education, make appointments/referrals for
follow-up services, perform PC and recovery room
responsibilities, perform basic lab work.
The Panel concluded that costs associated with fetal tissue transfer, an important activity
that requires permission from PPFA, is governed by PPFA guidance, and is not included in any
job description, sullies the credibility of a claim that actual costs are associated with the duties of
relevant employees.
F. Changing the Method of Abortion Procedure to Obtain More Fetal Tissue
The Panel investigated the possible impact on clinical medical care when a fetal tissue
procurement company enters into a contract to procure fetal tissue with a Planned Parenthood
affiliate clinic. The middleman company often embeds a tissue technician in a clinic on the days
that abortions are performed. The procurement company pays the clinic on a per tissue basis.
The number of saleable body parts in many ways depends upon the methodology of the doctor
performing the abortion.
Current federal law forbids changing of the method of abortion for the purpose of
obtaining tissue, but this prohibition applies only to fetal tissue that is to be used for transplant
purposes. The Panel noted the scope of the statute but also learned that in virtually every
instance, the doctor performing the abortion had no knowledge of whether the tissue was
destined for research or transplantation.
One Panel witness, Dr. Goldstein, was in fact procuring brain tissue from a Planned
Parenthood affiliate clinic and using it for transplant purposes.975 Thus, the Panel sought to
determine: (1) whether there was evidence that doctors changed the abortion procedure to serve
the goal of fetal tissue donation; and (2) whether particular doctors met with or learned from the
contracted embedded tissue technicians about what body parts they were procuring that day in a
way that promoted altered abortion procedures.
We use fetal astrocytes, which are vital to these investigations. . . . Now, as a result of the work in animals, we
have FDA approval to test these fetal stem cells in human patients . . . and have implanted them in four patients
within the past year. Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on
Energy and Commerce, 114th Cong., at 149 (unedited transcript) (Mar. 2, 2016) (Testimony of Lawrence Goldstein,
at 109-111), http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
975

352

Of additional concern to the Panel was the large number of intact calveriums (skulls) that
were being purchased by researchers. Since most second trimester abortions are D&E
procedures, the life of the baby is terminated inside the womb through dismemberment of the
various body parts. The challenge for procurement of the calverium is its size relative to the
amount of cervical dilatation. This inquiry took place during interviews with practicing abortion
doctors and relied upon the initial evidence from the CMP undercover videotapes.
1. Changing the Presentation of the Baby to Harvest a Calverium
In one section of a CMP video transcript, the undercover journalist (Buyer) is talking
with [PP Witness #1]:
Buyer: Yeah. Or especially brain is where its actually a big issue,
hemispheres need to be intact, its a big deal with neural tissue and
the progenitors, because those are particularly fragile. If youve got
that in the back of your mind, if youre aware of that, technically,
how much of a difference can that actually make if you
know kind of whats expected or what we need, versus
[PP Witness #1]: It makes a huge difference. Id say a lot of
people want liver. And for that reason, most providers will do
this case under ultrasound guidance, so theyll know where
theyre putting their forceps. The kind of rate-limiting step of
the procedure is the calvarium, the head is basically the biggest
part. Most of the other stuff can come out intact. Its very rare
to have a patient that doesnt have enough dilation to evacuate
all the other parts intact.
Buyer: To bring the body cavity out intact and all that?
[PP Witness #1]: Exactly. So then youre just kind of cognizant
of where you put your graspers, you try to intentionally go above
and below the thorax, so that, you know, weve been very good
at getting heart, lung, liver, because we know that, so Im not
gonna crush that part, Im going to basically crush below, Im
gonna crush above, and Im gonna see if I can get it all intact.
And with the calvarium, in general, some people will actually
try to change the presentation so that its not vertex, because
when its vertex presentation, you never have enough dilation at
the beginning of the case, unless you have real, huge amount of
dilation to deliver an intact calvarium. So if you do it starting
from the breech presentation, theres dilation that happens as
the case goes on, and often, the last, you can evacuate an intact
353

calvarium at the end. So I mean there are certainly steps that

can be taken to try to ensure
Buyer: So they can convert to breach, for example, at the start
of the
[PP Witness #1]: Exactly, exactly. Under ultrasound guidance,
they can just change the presentation.
Buyer: Okay.
[PP Witness #1]: So the preparation would be exactly the same, its
just the order of the removal of the products is different. And most
people see that as not very
Buyer: Yea, were not talking about it needs to be a hysterotomy or
anything, or something crazy like that, in order totheres probably
an easier solution to this problem.
[PP Witness #1]: And, weve been pretty successful with that. Id
say.976
Thus, the Panel sought to investigate instances of medically unnecessary changes to the
abortion procedure to obtain fetal tissue for transfer to a customer. In particular, the Panel noted
that if the tissue technician was seeking an intact calvarium, the doctor would use an ultrasound
to turn the baby to a breech position and then dismember the limbs and torso first so that greater
dilation could occur and increase the likelihood that when the time came to remove the
calvarium there might be greater dilatation.
This was not the only recounting by [PP Witness #1] of changing the method of abortion
to obtain an intact calvarium:
[PP Witness #1]: I let the tech tell me what it is that they need, I usually dont let the trainee do
those cases, I try to do everything as intact as possible, because I know its a research case.
She seems to be getting what she needs. Sometimes shell tell me she needs brain, and well
leave the calvarium until last, and then try to basically take it, or, actually, you know, catch
everything and even keep it separate from the rest of the tissue, so it doesnt get lost. There
will probably be providers who just want to keep

976

Center for Medical Progress, Transcript of Meeting with Senior Director, Medical Services, Planned Parenthood
of America at 11-12 (July 25, 2014), Exhibit 8.30.

354

doing things the way that they do them, and others who kind of want
to help facilitate the process.977
2. Abortion Doctor and Contract Tissue Technician Communicate Prior to the Abortion
Procedure
The Panel sought to learn whether contact between the embedded tissue technician and the
abortion doctor would lead to modification of the abortion procedure. This issue was raised in
the following undercover CMP video:
Buyer: So yesterday was a clinic day. So for example, what did
you procure?
[PP Witness #1]: You know I asked her at the beginning of the
day what she wanted, yesterday she wanted, shes been asking,
a lot of people want intact hearts these days, theyre looking for
specific nodes. AV nodes, yesterday I was like wow, I didnt even
know, good for them. Yesterday was the first time she said
people wanted lungs. And then, like I said, always as many intact
livers as possible. People just want
Buyer: Yeah, liver is huge right now.
[PP Witness #1]: Some people want lower extremities too, which,
thats simple. Thats easy. I dont know what theyre doing with
it, I guess if they want muscle. . . .
Buyer: And so, if its something as simple as converting to breech
that doesnt require a separate consent? Does that make the
procedure take longer? Is that another step for the provider?
[PP Witness #1]: No, its just what you grab versus what comes out.
It doesnt make anything any different.978
3. Training of Clinic Personnel and Doctors is Required to Improve the Likelihood of Intact
Tissue from an Abortion
The Panel also sought to investigate the impact on the conduct of all clinic employees
under a contractual environment with an outside fetal tissue procurement company. For example,
would such a contract lead to a change in training personnel about the importance of conducting
the abortion procedure in such a way that promotes the harvesting of intact fetal organs?
977

Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform
FNNF0991_20140408125926 (emphasis added).
978
Center for Medical Progress, Transcript of Meeting with [PP Witness #1] at 12-13 (July 25, 2014) (emphasis
added), Exhibit 8.30.

355

PP: The other consideration I think you guys need to make, is who
does the training. Because when they do the training, youre
basically guaranteed to not get anything.
Buyer: Oh, you mean when its a provider whos been training.
PP: One whos training, whos basically doing the procedure, it
comes out in a thousandyoure not going to get anything intact,
so. What we did for a while, and I think it worked pretty well if
theres a trainee, Id say, any research case, Ill do. And as you
get better, Ill let you do more, but we really need to do this, intact.979
This section of transcript provides a further inference that some doctors work at their abortion
technique in a way that promotes intact fetal organs, while others who are just starting or who are
less experienced will produce an abortion that comes out in a thousand parts.
Some Planned Parenthood doctors took a cavalier approach to providing fetal tissue to a
middleman company. In another video,980 one of the journalists is talking to two Planned
Parenthood Gulf Coast workers, [PPGC Abortion Services Official] and [PPGC Abortion
Doctor]. They are both excitedly talking about partnering with Biomax (the fake TPC company)
and the thrill of pulling out intact body parts. [PPGC Abortion Services Official] leans over to
the journalist and says, Were a little different than other providers . . . Yeah Im like,
Yeah I have like a leg for you! Im like, oh shit, if other people were to hear me theyd be
like, You are fucking evil.
4. Panel Interviews Consistent with the CMP Undercover Videos
The Panel did not set out to prove or disprove the veracity of the CMP videos. Instead
they were viewed as citizen leads that might reveal matters that impact the effectiveness of
federal law. The Panel conducted transcribed interviews with Planned Parenthood executives,
policy makers, and abortion doctors to further investigate the influence of a contracted tissue
technician in Planned Parenthood affiliate clinics. The transcript below recounts a series of
questions between Panel staff and a Planned Parenthood executive about the relationship
between the doctor and the tissue technician:
BY MR. BELL:
Q

Now, do you think that doctors in your position should

huddle in the morning?
You say, I like to do that. Its sort of an ongoing tense.

979

Center for Medical Progress, Transcript of Meeting with [PP Witness #1] at 13 (July 25, 2014) (emphasis added),
Exhibit 8.30.
980
Center for Medical Progress videotape produced to the Committee on Oversight and Government Reform,
FNND0569_20150419155634.

356

Do you think the doctors should huddle with a tissue tech to

see what theyre procuring, is on their list that day?
A

I dont really have a feeling as to whether other doctors did.

I like to be helpful.

And so you found it helpful that at least on this one day to

huddle with the tissue tech and learn what [Procurement
Technician] was searching for, what orders she had; is that
right?

I would ask her what tissue she was looking for, yes.

All right. Do you think that's a good idea for the whole fetal
tissue donation program, that doctors and the tissue techs
huddle each morning to discuss what they're going to try and
procure that day?

I think it could be helpful.981

After establishing that [PP Witness #1] believed that it would be helpful to meet with the
contract tissue technician, she was asked whether she believed the method of the abortion could
be changed to increase the likelihood of success:

981

BY MR. BELL:
Lets skip down just a couple lines. You say, You know, everyone
ha[s] [sic] a different technique. So thats the thing. Theres
definitely local variance like, you know, no two people do a C
section the same way; no two people do a hysterectomy the same
way; no two people do a D&E the same way.
And this is the part Im interested in getting your opinion on.
With that said, if you maintain enough of a dialogue with the person
whos actually doing the procedure so they understand what the end
game is, there are little things, changes they can make in their
technique to increase your success.
What did you mean by that sentence?

I mean exactly what it said, which is theirproviders can change

their technique to increase success.

What would thatwhat would be that change in technique?

I cant speak for every provider. Ifevery procedure is different.

Providers make changes in technique as theyre doing a procedure

Transcribed Interview of [PP Witness #1] at 142 (Oct. 6, 2016), Exhibit 8.31.

357

the whole time for a variety of reasons. There are probably a myriad
of changes that can be made.
Q

Okay. Which ones could be made to increase the success of a fetal

tissue donation?

Thats a very broad question and I think unless we were talking

about a specific procedure I couldnt answer it for you.

There are little things they can make in their technique to increase
your success. What are those little things?

Again, as I mentioned, a change in instruments, a change in

where theyre grasping the tissue. These are changes in
technique that a provider can make for a variety of reasons. I

But it could be made to increase the success of fetal tissue

donation.

Yes, that's what Im saying.

Okay. Now, so those little techniques that you just described, if there
was no fetal tissue donation to increase the likelihood of success,
they wouldntthey wouldnt make those little changes, would
they?

Well, providers make changes in technique for a variety of reasons.

Right. They would making them for other reasons, other than
likelihood of success; isnt that right?

[Pause.]

Mr. Bopp. Why dont you ask her the question directly, if she ever changes
technique in order to
Mr. Bell. Well, you suggest that providers may includethere are little
things they can make in their technique to increase their success.
You said what those were.

BY MR. BELL:
Now, the question is: if there was no fetal tissue donation, those little
things, changes that would be made to increase their likelihood of
success, those wouldn't be made, would they?
358

Well, I cant say across the board they wouldnt be made because
there's probably other reasons that a provider during a procedure

They wouldnt be made for the purpose of getting fetal tissue,

would they?

No, they wouldnt.

So they would be made for other reasons.

Yes.

So one set of little changes is chosen for other medical reasons,

and one set of little changes could be chosen to increase the
likelihood of success.

Yes.

Thank you.982

It is clear that the PPFA executive in charge of directing the MS&G guidelines, [PP
Witness #1], altered the method of the abortion procedure in her own practice. It is also clear that
she has not complied with the directive of the MS&G manual regarding the requirement to
affirm that the method of the abortion has NOT been changed to promote fetal tissue donation.
The guidelines specifically require, Notation signed by the clinician performing the abortion
that . . . . no substantive alteration in the timing of terminating the pregnancy or of the method
used was made for the purpose of obtaining the blood and/or tissue.983
During an interview with Panel staff, [PP Witness #1] was asked:
Q

Do you sign those documents after every abortion youve

participated in where there was a donation of blood or
tissue?

Are you asking me if I have personally signed aa

statement to this effect?

Yes.

I have never signed a statement to this effect.

Have you ever been a clinician performing an abortion?

982

Transcribed Interview of [PP Witness #1] at 181-82 (Oct. 6, 2016) (emphasis added), Exhibit 8.32.
Programs for Donation of Blood And/Or Aborted Pregnancy Tissue For Medical Research, Education, or
Treatment (Revised, June 2011) [PPFA-HOU_E&C-000029-30], Exhibit 8.33.
983

359

I think we know I have.

But this is in the manual, and it says that someone is

supposed to sign this document noting these three square
bullets. Am I misunderstanding something?

No, I dont think you are. . . .

Q.

Well, you never signed on at any PP where you worked.

Thats correct.984

G. Planned Parenthood Affiliates Violated the Federal Guidelines on Patient Consent

1. Summary
Planned Parenthood affiliates were provided a form as part of the MS&G guidelines to
obtain consent from patients for fetal tissue donations.985 Some affiliates contracted with tissue
procurement businesses (TPBs) who embedded technicians inside the affiliate clinics and who
also provided their own version of a patient consent form.986 The Panel learned that the form
sanctioned for use by PPFA and used by Planned Parenthood abortion clinics and the forms often
provided by outside TPBs do not meet federal consent requirements. Under the principles
outlined in the Belmont Report, human research subjects must provide informed consent before
they participate in a study. During the Panels hearing on Bioethics and Fetal Tissue, witnesses
agreed that Planned Parenthoods consent form was insufficient for obtaining informed
consent.987 Further, a comparison of Planned Parenthoods form and the form used by another
fetal tissue supplier highlights the stark differences between a consent process that fails to meet
federal requirements and a sufficient consent process. Finally, Planned Parenthood executives
admitted that the form was legally insufficient.
2. Legal background988
The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research was created on July 12, 1974, with the enactment of the National Research

984

Transcribed Interview of [PP Witness #1] at 178-82 (Oct. 6, 2016), Exhibit 8.32
Planned Parenthood consent form, [STEM.HOUSE.OGR_000007-8 / STEM.HOUSE.SELECT_0173-4]
Exhibit 8.34
986
Stem Express consent form, [STEM.HOUSE.OGR_00009-12 / STEM.HOUSE.SELECT_0175-0178]
See Exhibit 8.35
987
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., (unedited transcript) (Mar. 2, 2016) (testimony of Paige Cunningham, at 77, testimony of Lawrence
Goldstein at 149). http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript20160302.pdf
988
For a more detailed examination of these laws, see Chapter 2 supra.
985

360

Act.989 The need for this Commission and for standardized protections for human research
subjects became painfully evident after the Tuskegee Syphilis study received public scrutiny in
1972. One of the striking problems with the Tuskegee Syphilis study was the complete absence
of informed consent from study participants. There was no evidence that the researchers had
informed the participants, who thought they were receiving medical treatment, of the study or its
real purposein fact, they were misled and had not been given all the facts required to provide
informed consent.990
Given that background, it is not surprising that respect for persons is one of the three
principles of biomedical research included in the Commissions Belmont Report. Obtaining
informed consent from patients or study participants is a critical component of respecting
persons. Today, laws and regulations require informed consent from study participants. Under
the Common Rule,991 human subjects must give informed consent before research may take
place. Further, an Institutional Review Board (IRB) must review the proposed research project,
and IRB approval requires researchers to obtain informed consent.992 Also, under federal law,
research using fetal tissue requires a mothers written consent.993 State anatomical gift acts also
require informed consent.
3. The Panel asks experts to evaluate Planned Parenthoods consent form
During the Panels hearing on Bioethics and Fetal Tissue, Rep. Vicky Hartzler (MO-4)
addressed an important statement in the Belmont Report regarding informed consentthat
inducements [to consent] that would ordinarily be acceptable may become undue influences if
the [research] subject is especially vulnerable.994 She asked an ethics expert if a form known to
be widely used by Planned Parenthood abortion clinics to obtain a mothers consent to donate
fetal tissue complied with HHSs mandate against inducement.995 The form stated:
Research using the blood from pregnant women and tissue that has
been aborted has been used to treat and find a cure for such diseases
as diabetes, Parkinsons disease, Alzheimers disease, cancer, and
AIDS.996

989

P.L. 93-348.
See The Tuskegee Timeline, CDC, http://www.cdc.gov/tuskegee/timeline.htm.
991
45 C.F.R. 46.
992
45 C.F.R. 116.
993
42 U.S.C. 289g-1.
994
The Belmont Report, Office of the Sec., Ethical Principles and Guidelines for the Protection of Human Subjects
of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (1979), http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/.
995
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong. At 77 (unedited transcript) (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
996
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., Majority exhibit A-3 (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-20160302-SD030.pdf (emphasis
added).
990

361

The witness agreed that this was an important question, because the idea of the
promise of cures found in the form was a very powerful motivator.997 The witness also
indicated that the consent form was deficient in other ways: The concern I have is that the
standards that we have typically for fetal tissue donation are just absent here. And so in addition
to the voluntariness, there is just the thoroughness of the consent [that] seems to be missing in
this form.998
A researcher invited by the minority to testify agreed, stating that the form would not
have made it past his IRB.999 The testimony provided by all witnesses invited by both the
majority and minority raised concerns that the principles embodied in the Belmont Report, and
later incorporated into federal regulations, are not being followed by abortion providers seeking
consent for the donation of human fetal tissue.
4. Planned Parenthoods consent form is inadequate compared to other entities consent
forms
The stark contrasts between Planned Parenthoods consent form and forms used by other
entities providing fetal tissue further demonstrate the inadequacies of Planned Parenthoods
consent process. In addition to containing wildly inaccurate claims about past results from fetal
tissue research, Planned Parenthoods one-page form fails to provide basic information about the
purpose for which the donation is being sought and the precise nature of the pregnancy tissue
being donated.
The University of Washington Birth Defects Research Laboratorys lengthy consent
form, in contrast, states the purpose of the study (i.e., to study birth defects and other diseases),
and graphically describes aspects of the fetal tissue procurement process. Further, the form
acknowledges that [e]xamples of tissue collected and sent to scientists for study are: brain, liver,
kidney, ovary or testis, eyes, and skin.1000 In other words, the mother is being asked to donate
her deceased infants body parts, not mere pregnancy tissue (as it is described in the Planned
Parenthood form).
The Panel also uncovered a series of tissue procurement contracts between StemExpress
and three abortion clinics: Planned Parenthood Mar Monte (PPMM), Planned Parenthood Shasta
Pacific (PPSP), and Family Planning Specialists Medical Group (FPS). PPMM and PPSP may
have used both StemExpress consent form and the Planned Parenthood consent form described

997

Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., at 77 (unedited transcript) (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
998
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., at 77 (unedited transcript) (Mar. 2, 2016) (testimony of Paige Cunningham),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
999
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., at 149 (unedited transcript) (Mar. 2, 2016) (testimony of Lawrence Goldstein),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Transcript-20160302.pdf.
1000
University of Washington Birth Defects Research Laboratory, Consent form for the Donation of Embryonic or
Fetal Tissue, Exhibit 8.36.

362

above. StemExpress form also fails to meet federal requirements and leads with extravagant
promises:
Research using donated tissue and blood is currently underway to
uncover the causes of and ultimately find cures for things like: Heart
Disease, Diabetes, Parkinsons Disease, Sickle Cell Anemia,
Leukemia, Lymphoma, Cancer, Spinal Cord Disease, and many
more. 1001
Further, the StemExpress form fails to provide any details regarding the purposes for
which donated tissue may be used. Like Planned Parenthoods form, the StemExpress form
refers to pregnancy tissue without acknowledging the nature of that tissue (e.g., fetal heart,
lungs, eyes).
5. The Planned Parenthood consent form does not indicate whether the tissue will be used
for education, research, or treatment, including transplantation
As discussed above, the Planned Parenthood consent form does not provide any detailed
information about how donated fetal tissue will be usedthe form simply states that blood
and/or the tissue from the abortion [will be] used for education, research, or treatment. Further,
the form states that the patient understand[s] that there will be no changes to how or when [her]
abortion is done in order to get [her] blood or the tissue.1002
Given that neither the abortion provider nor the patient knows the intended use for the
tissue, and that the consent form explicitly states that there will be no changes to the patients
abortion procedure, Planned Parenthood is obligated to comply with the federal law stating, No
alternation of the timing, method, or procedures used to terminate the pregnancy [may be] made
solely for the purpose of obtaining the tissue.1003
Planned Parenthood Executives agreed that the consent form was legally insufficient
During an interview with Panel staff, [PP Witness #1] agreed that Planned Parenthoods
consent form was problematic:
If Im evaluating the form now, you are correct. To my knowledge there is no
cure for AIDS. So that is probably an inaccurate statement. . . . a consent form
should not have an incorrect statement.1004
[PP Witness #2] stated, I would agree that that is insufficient for obtaining informed consent,
correct.1005

1001

See Exhibit 8.34

Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., Majority exhibit A-3, at 3 (Mar. 2, 2016),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-20160302-SD030.pdf.
1003
42 U.S.C. 289g-1(b)(2)(A)(ii).
1004
Transcribed Interview of [PP Witness #1] at 131-32 (Oct. 6, 2016), Exhibit 8.37.
1005
Transcribed Interview of [PP Witness #2] at 45 (Oct. 19, 2016), Exhibit 8.38.
1002

363

6. PPFA Executive suggests that the middleman obtain the consent to donate tissue
Even with the admission that PPFA consent form is adequate, the following excerpt from
an undercover video by investigative journalists reveals how [PP Witness #1] explained to a
potential TPB how to provide a comprehensive service that would be attractive to surgical
abortion centers. In particular, the advice focused on the embedded tissue technician doing the
consent.
[PP Witness #1]: I would say, barring [sic] some bizarre space issue,
because some places have very limited space. Some people would
be happy to do as little for you as possible. The more you can do for
them, the easier it is. That includes consenting the patients
Buyer: Right, because I was imagining [we] would be doing consent
a well.
[PP Witness #1]: Thats probably the biggest inconvenience, ugh
thats one more thing my staff has to talk about. They only have so
many minutes to talk to the patient. If you said youre going to do
all the consenting, youre going to collect the tissue, I dont know
who would really say no. I really dont.
Buyer: Thats really what they want to hear.
[PP Witness #1]: Thats what they want to hear, they want to hear
you basically say, other than taking up a little bit of space, this is
going to be as low impact as possible, on you and your flow. Youre
going to need a room, somewhere to consent the patients, once the
patient is ready to be consented. So, youre going to need space in
the lab, youre going to need a place to consent. Thats it, otherwise,
as long as you dont leave anything behind, theyre going to be
happy. There are affiliates who have been doing this for so long,
they have staff that are so good at it, they may just say, that its
something that staff can do. Especially because you know, they
know how to identify some stuff. They probably wouldnt know
how to identify the stuff you need. Theyre looking for basically, all
of the limbs a thorax a head, to present them, Weve got it all.
Thats the only concern.1006
The buyer then asks about the time that an abortion clinic staff spends with the patient. This
time frame is particularly limiting to the integrity of the consent process.

1006

Center for Medical Progress, Transcript of Meeting with [PP Witness #1] at 13-14 (July 25, 2014), Exhibit 8.39.

364

[PP Witness #1]: How long, right now, is the average amount of
time they spend with a patient?
PP: I would say about ten minutes.
[PP Witness #1]: Per patient.
PP: Per patient. yes. And also contraceptive counseling and all that.
Buyer: Thats all pre procedure, pre op.
[PP Witness #1]: The layout of the actual Planned Parenthood is
counseling rooms and procedure rooms. So, yea those are just
counseling rooms with a desk and a chair.
Buyer: Certainly, Im not an expert in your clinic flow, I dont
presume to know where would best fit in. But, I know that what
weve done for other practices, for example the cosmetic facilities.
We have a clinic float, our tech kind of acts as a float, they have
their clipboard, and kind of mark down all the interested patients,
you know ahead of time to try to facilitate that. I dont know if that
will help or hinder your process.
[PP Witness #1]: Thats how it works with a lot of the researchers,
as well. They kind of just identify who is interested.1007
H. StemExpress and Planned Parenthood abortion clinics appear to have committed
systematic violations of HIPAA
1. Summary
As discussed above, the Panels investigation uncovered a series of business contracts
between StemExpress1008 and several Planned Parenthood abortion clinics. These contracts
included provisions for the payment of fees by StemExpress to the Planned Parenthood abortion
clinics for fetal tissue and maternal blood. StemExpress then resold the fetal tissue and blood to
researchers.
StemExpress and at least two of these Planned Parenthood abortion clinicsPlanned
Parenthood Mar Monte (PPMM) and Planned Parenthood Shasta Pacific (PPSP)appear to have
committed systematic violations of the Health Insurance Portability and Accountability Act of
1996 (HIPAA) privacy rule from about 2010 to 2015. These violations occurred when the
Planned Parenthood clinics intentionally disclosed patients individually identifiable health

1007
1008

See id.
StemExpress and Stem-Ex are the same company.

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information to StemExpress to facilitate the TPBs efforts to procure human fetal tissue for
resale.
The Panel filed a complaint against each of these entities requesting a swift and full
investigation by the Office of Civil Rights in the Department of Health and Human Services on
June 1, 2016.
2. Legal Background
As discussed above,1009 the HIPAA privacy rule (Privacy Rule) protects all protected
health information (PHI) held or transmitted by a covered entity or its business associate.1010
PHI identifies an individual, or can reasonably be believed to be useful in identifying an
individual, and includes demographic data relating to an individuals health condition, health
care, or payments for the provision of health care.1011 A covered entity may not use or disclose
an individuals PHI except as the Privacy Rule permits or requires,1012 or as the individual or
their representative authorizes in writing. Civil monetary penalties may be imposed, and criminal
fines or imprisonment can follow violations of the Privacy Rule.1013
3. Factual Background
The Planned Parenthood abortion clinics are covered entities under HIPAA while
StemExpress is not.1014 StemExpress procure[s] tissues and isolate[s] cells for researchers
individual needs in its own labs.1015 From about 2010 to 2015, the Planned Parenthood abortion
clinics collaborated with StemExpress by permitting StemExpress employees to: enter their
clinics and procure human fetal tissue from aborted infants; obtain individually identifiable
health information, or protected health information (PHI) about their patients; interact with
patients; and seek and obtain patient consent for tissue donation.1016 StemExpress embedded
tissue procurement technicians inside the Planned Parenthood abortion clinics whose work
sequence followed a daily routine:
1) A researcher/customer placed an order for human fetal tissue using an online business
portal provided by StemExpress, requesting a particular gestational range for the fetal
tissue.1017

1009

See Chapter II.A.4 supra.

45 C.F.R. 160.103.
1011
Id.
1012
45 C.F.R. 164.502(a).
1013
Pub. L. 104-191; 42 U.S.C. 1320d-51320d-6.
1014
See 45 C.F.R. Part 160.103 (Covered Entity means: (1) A health plan. (2) A health care clearinghouse. (3) A
health care provider who transmits any health information in electronic form in connection with a transaction
covered by this subchapter.) See also OCR Privacy Brief, Summary of the HIPAA Privacy Rule,
http://www.hhs.gov/sites/default/files/privacysummary.pdf (used as reference throughout this section).
1015
StemExpress, About Us, http://stemexpress.com/about/.
1016
See Clinic Procedures & Policies, Exhibit 8.40.
1017
See Researcher Procurement Record, Exhibit 8.41.
1010

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2) The Planned Parenthood abortion clinic faxed the next days schedule of potential
patients directly to the StemExpress tissue procurement technician assigned to the
clinic.1018
3) The day the abortion procedures were scheduled, StemExpress posted the order on a
website task board (order page) to be accessed by their procurement technician planted
in the Planned Parenthood abortion clinic, or communicated the order to the tissue
technician via email.1019
4) The StemExpress procurement technician informed the Planned Parenthood clinic what
they wished to procure (i.e., the type of tissue and gestational range) based on the order
page, and the abortion clinic staff member provided the medical files, including PHI, for
the patients with abortions scheduled for that day.1020
5) The StemExpress procurement technician then sought out particular patients by name and
obtained their consent to donate fetal tissue while they were awaiting their procedures.
The Planned Parenthood abortion clinic also permitted the procurement technician to
interview patients and obtain their PHI.1021
6) StemExpress procurement technicians were paid an hourly wage and a per tissue bonus
for each item they procured from the order page.1022
7) StemExpress paid the Planned Parenthood abortion clinic for each fetal tissue and each
blood sample and then marked up the tissue four to six hundred percent for resale to the
researcher.1023
The work sequence, when combined with supporting documentation, reveals that
StemExpress did not have a medically valid reason to see, and the Planned Parenthood abortion
clinics did not have a reason to provide, patients PHI. Instead, the Planned Parenthood abortion
clinics shared patients PHI with StemExpress in furtherance of contractual agreements that
financially benefited StemExpress and the Planned Parenthood abortion clinics.1024

1018

See Fax from The Alameda, San Jose [Planned Parenthood clinics] to StemExpress (Jan. 10, 2013), Exhibit 8.42.
See Updated Task Assignment: Procurement Schedule Wednesday, 3/20/13 and Navigating the Task Board,
Exhibit 8.43.
1020
See StemExpress Emails, Exhibit 8.44.
1021
See Clinic Procedures and Policies, See Exhibit 8.40; Consenting Patients, Exhibit 8.45.
1022
See Procurement Technician Compensation Policy for Tissue and Blood Procurement, Exhibit 8.46.
1023
See StemExpress Services Agreement with Planned Parenthood Shasta Pacific; StemExpress Services
Agreement with Planned Parenthood of Santa Barbara, Ventura & San Luis Obispo Counties; Purchase Order No.
60856806; Purchase Order No. 3000014694; Purchase Order No. 60836838; Purchase Order No. 60858758; and
StemExpress Invoice # 1439, Exhibit 8.47.
1024
See Standard Operating Procedure, Exhibit 8.48.
1019

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4. The Contracts between StemExpress and the Planned Parenthood abortion clinics
Particular language, contained within the four corners of the written contracts between
StemExpress and the Planned Parenthood abortion clinics, raises serious concerns that the parties
violated the Privacy Rule:
[a]ny information obtained from [the Planned Parenthood abortion clinics]
patients charts shall be privileged, and [Stem-Ex/StemExpress] will treat the
information in order to preserve the confidentiality of the patients. [StemEx/StemExpress] will not receive any information concerning identity of donors
except as necessary to obtain patients consent for use of POCs and maternal
bloods (emphasis added).1025
This admission, on the face of the contracts, that the Planned Parenthood abortion clinics
granted StemExpress access to patients PHI raises the question whether any HIPAA provision
permits or requires such disclosure without patients express authorization. This question is
compounded by the contracts admission that StemExpress reviewed PHI prior to obtaining
patients consent to donate fetal tissue or patients authorization to view their PHI.
5. Violations of the HIPAA Privacy Rule by StemExpress and the Planned Parenthood
Abortion Clinics
The agreements between StemExpress and the Planned Parenthood abortion clinics, on
their face and in practice, appear to be fundamentally flawed. A contractual agreement requiring
StemExpress to treat the information obtained from patients charts in order to preserve the
confidentiality of the patients cannot trump a law prohibiting the Planned Parenthood abortion
clinics from permitting these disclosures in the first place. As discussed below, the Planned
Parenthood abortion clinicscovered entities under HIPAAwere not permitted to disclose or
make available to StemExpress any patients PHI without the patients express authorization.
The Planned Parenthood abortion clinics and StemExpress violated the HIPAA privacy
rule because: (1) The disclosures of patients PHI made by the Planned Parenthood abortion
clinics, and received by StemExpress, were neither required nor permitted under HIPAA, and in
particular did not meet the exceptions for cadaveric organ, eye, or tissue transplantation, or for
research; (2) The consents for fetal tissue donation ostensibly obtained by StemExpress from the
Planned Parenthood abortion clinics patients did not constitute sufficient authorizations for the
disclosure of PHI; (3) The disclosures of patients PHI made by the Planned Parenthood abortion
clinics to StemExpress were not the minimum necessary disclosures to facilitate the procurement
of human fetal tissue from aborted infants; and (4) StemExpress is not a Business Associate of
the Planned Parenthood abortion clinics under HIPAA.

1025

See Contracts, Exhibit 8.49 (emphasis added).

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6. The disclosures of patients PHI made by the Planned Parenthood abortion clinics, and
received by StemExpress, were neither required nor permitted under HIPAA, and in
particular did not meet the exceptions for cadaveric organ, eye, or tissue transplantation,
or for research
The disclosures of PHI that the Planned Parenthood abortion clinics made to
StemExpress are neither required1026 nor permitted1027 by law. StemExpress was not involved in
the treatment of patients, in the payment for treatment, or in clinic operations.1028 Rather,
StemExpress wanted patients PHI to facilitate the procurement of human tissue from aborted
infants for resale to researchers, and the Planned Parenthood abortion clinics benefited from this
arrangement because StemExpress paid them for the tissue.
a) Cadaveric organ, eye, or tissue transplantation
Importantly, Planned Parenthoods disclosures to StemExpress do not fall under the
provision in law permitting disclosure of PHI to aid organ transplantation. While the contracts
reference the National Organ Transplant Act,1029 the Planned Parenthood abortion clinics were
not facilitating the donation and transplantation of cadaveric organs, eyes, and tissue. Instead,
the clinics were facilitating the donation of human fetal tissue from aborted infants for research,
which is not covered by the cadaveric organ, eye, or tissue exception.1030
b) Research
Further, Planned Parenthoods disclosures to StemExpress do not meet the rigorous
requirements applicable to PHI disclosures for research purposes. A covered entity is not
permitted to disclose an individuals PHI for research purposes without the individuals
authorization unless the covered entity (1) obtains verification of approval from an Institutional
Review Board (IRB) for disclosure without authorization; (2) the researcher represents that the
use or disclosure of the PHI is solely to prepare research protocol and the PHI will not be
removed from the covered entity, and that the PHI is necessary for the research; or (3) the
research is on PHI of deceased individuals.1031
c) Violations Preceding Consent
Because StemExpress employees actually sought consent for tissue donation from
patients, the Planned Parenthood abortion clinics permitted the employees to view patients
charts. Medical charts are filled with HIPAA-protected PHI, including names, addresses, past

45 C.F.R. 164.502(a)(2) (The only required disclosures are to (1) an individual or their personal
representative when they request access to, or an accounting of disclosures of, their protected health information;
and (2) to HHS when it is undertaking compliance investigation or review or enforcement action).
1027
See 45 C.F.R. 164.502(a)(1).
1028
See 45 C.F.R. 164.506(c).
1029
42 U.S.C. 274e(c)(1).
1030
See 45 C.F.R. 164.512(h).
1031
45 C.F.R. 164.512(i).
1026

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and present medical treatment, and more. Each time a Planned Parenthood employee shared a
medical chart with a StemExpress employee, both violated the HIPAA privacy rule.
No evidence suggests the Planned Parenthood abortion clinics patients provided
authorization for StemExpress staff to view their PHI prior to seeking their consent to donate
tissue. Therefore, regardless of whether a patient ultimately consented to tissue donation and
authorized disclosure of her PHI to StemExpress, her privacy was violated.
The Planned Parenthood abortion clinics could have directly consented their patients for
tissue donation, and entered an agreement with StemExpress to provide a limited data set1032
regarding the patients they were seeing on a particular day. Instead, they violated the Privacy
Rule by permitting StemExpress to view the most intimate information about their patients.
These disclosures made by the Planned Parenthood abortion clinics to StemExpress were
inarguably direct and intentionalnot incidental.1033 StemExpress employees did not merely
overhear a patients name while in the clinicthey were handed her medical chart by her
Planned Parenthood healthcare provider in blatant violation of the HIPAA privacy rule.
7. The consent for fetal tissue donation obtained by StemExpress from the Planned
Parenthood abortion clinics patients did not constitute sufficient authorizations for the
disclosure of PHI
While StemExpress purportedly obtained consents from patients prior to procuring
human fetal tissue from their aborted infants, the forms that they used were insufficient to
authorize the disclosure of PHI under the HIPAA privacy rule. The Privacy Rule requires a
covered entity to obtain an individuals written authorization for any use or disclosure of PHI
that is not permitted or required by law.1034 Such authorization must be in plain language and
contain specific information regarding the information to be disclosed or used, the person(s)
disclosing and receiving the information, expiration, right to revoke in writing, and other
data.1035
Neither the consent form provided by StemExpress nor the consent form provided by
Planned Parenthood to obtain patient consent for the donation of human fetal tissue of aborted
infants met these stringent requirements.1036 The statement in the StemExpress form that a
patients health information will be protected at all times is ironic given that StemExpress
possession of the patients PHI already placed the Planned Parenthood abortion clinics and
StemExpress in violation of the HIPAA privacy rule.

1032

See 45 C.F.R. 164.514(e).

See 45 C.F.R. 164.502(a)(1)(iii).
1034
45 C.F.R. 164.508.
1035
45 C.F.R. 164.508(c).
1036
See StemExpress consent form, Exhibit 8.35, and Planned Parenthood consent form, Exhibit 8.34.
1033

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The StemExpress form also stated that [i]n accordance with federal laws (HIPAA), your
personal identifying information will be protected . . . health information . . . may be used or
disclosed . . . [but] will NOT be connected to your name or any other personal identifier.1037
Like the privacy provision in the contracts between StemExpress and the Planned
Parenthood abortion clinics, this nod towards HIPAA requirements failed to meet the
requirements of the HIPAA privacy rule. The StemExpress form did not describe the specific
patient information that will be disclosed or used, but rather provided a generic, nonexclusive list
of information that may be disclosed. The StemExpress form did not state who will disclose or
use the patients PHI. It also did not state when the patients authorization will expire, or that the
patient can withdraw her authorization for the use of her PHI (it mentioned that the patient
cannot withdraw her consent to the tissue donation after she leaves the clinic).
The Planned Parenthood form, purportedly used to obtain patient consent for human fetal
tissue donation at Planned Parenthood Mar Monte and Planned Parenthood Shasta Pacific,1038
was grossly insufficient. The form did not address privacy at all, with no information regarding:
PHI that may be disclosed or used; the person(s) disclosing and receiving the PHI; any expiration
on the availability of the patients PHI to researchers or others; or the patients right to revoke
her authorization in writing.
One former StemExpress procurement technician, [Procurement Technician], was
embedded at several California Planned Parenthood clinics and told investigative journalists of
repeated consent violations she witnessed during her time with Planned Parenthood. In one
instance, [Procurement Technician] told a StemExpress coworker that a woman had refused to
consent to a blood draw for donation, but the coworkerwith full knowledge of the patients
refusaldrew her blood anyway the following day without telling her it was for
StemExpress.1039
8. The disclosures of patients PHI made by the Planned Parenthood abortion clinics to
StemExpress were not the minimum necessary disclosures to facilitate the procurement
of human fetal tissue from aborted infants
The Planned Parenthood abortion clinics and StemExpress violated a central aspect of the
Privacy Rule by disclosing/obtaining more than the minimum necessary PHI to facilitate the
procurement of human fetal tissue from aborted infants.1040 StemExpress employees did not need
to know the names of patients, and they certainly did not need to directly obtain the patients
consent in order to procure fetal tissue. Instead, these deeply private activities could have been
performed by Planned Parenthood employees.

1037

StemExpress Consent Form, Exhibit 8.35.

Planned Parenthood consent form, Exhibit 8.34.
1039
Human Capitol-Episode 2: Inside the Planned Parenthood Supply Site (YouTube)
https://www.youtube.com/watch?v=ABzFZM73o8M (5 minutes, 30 seconds).
1040
45 C.F.R. 164.502(b) and 164.514(d).
1038

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As addressed above, the Planned Parenthood abortion clinics could have established a
relationship with StemExpress that did not require or result in the disclosure of any PHI. Instead,
the Planned Parenthood affiliates permitted StemExpress to use PHI to directly encourage
patients to donate human fetal tissuetissue for which Planned Parenthood would be paid, and
that would later be sold by StemExpress to researchers at a huge mark-up.
9. StemExpress is not a Business Associate of the Planned Parenthood abortion clinics under
HIPAA
A Business Associate under HIPAA is a person or organization, other than a member of a
covered entitys workforce, that performs certain functions or activities on behalf of, or provides
certain services to, a covered entity that involve the use or disclosure of individually identifiable
health information. Business Associates are generally involved in claim processing, data analysis,
utilization review, and billing. Their services are limited to legal, actuarial, accounting,
consulting, data aggregation, management, administrative, accreditation, or financial services,
where the provision of the services involves the disclosure of PHI.1041
Clearly, StemExpress did not perform any of these services for the Planned Parenthood
abortion clinics, and is therefore not a Business Associate permitted to obtain the PHI of the
Planned Parenthood abortion clinics patients.

1041

45 C.F.R. 160.103.

372

IX. Biomedical Research and Human Fetal Tissue

Chapter IX Redaction Key:
Chapter IX cites numerous academic articles. None of the individuals in this chapter were
part of the Panels investigation into transactions involving fetal tissue. Thus, the names are left
unredacted due to their academic contribution to biomedical research.
A. Success of the United States Biomedical Research Enterprise
The United States of America is a global leader in scientific research. A comprehensive
report of world-wide research investment indicates that the 2014 gross expenditure on Research
and Development (R&D) in the United States exceeded $485 billion, or nearly 27% of the global
R&D budget.1042 The same pattern holds for U.S. investment in biomedical research. A recent
report in the New England Journal of Medicine indicates that the 2012 biomedical research
expenditures in the United States exceeded $119 billion, with the next largest national
investment being made by Japan, at just over $37 billion.1043 Corresponding to this strong
financial commitment, the United States is also global leader in biomedical research publication
and innovation. For example, between 2000-2013, the Unites States published approximately
40% of all papers in the area of stem cell research, with the next closest contributor (the United
Kingdom) producing less than 10% of all published research in this rapidly advancing field.1044
The National Institutes of Health (NIH) invests approximately $32 billion annually in
medical research, funding over 300,000 researchers both in the United States and around the
world.1045 The NIH research portfolio includes over 83 thousand active projects.1046 In addition,
there are currently over 228 thousand U.S.-funded clinical trials both within the U.S. and
abroad.1047 This represents a massive research effort directed both at understanding the basic
mechanisms of human disease and at discovering novel treatments to relieve human suffering.
American citizens have every right to be proud of the research enterprise in our country,
and are wise to support it with tax dollars. The House Select Investigative Panel shares this
support. We are strongly committed to promoting both basic and clinical research. However, as
the history of biomedical research in the 20th century clearly demonstrates, when scientific
research is uncoupled from either ethics or the law, grave injustice can result.1048 Protections for
1042

2016 Global R&D Funding Forecast,

https://www.iriweb.org/sites/default/files/2016GlobalR%26DFundingForecast_2.pdf.
1043
Asias ascentglobal trends in biomedical R&D expenditures. Chakma J, Sun GH, Steinberg JD, Sammut SM,
Jagsi R. N Engl J Med. 2014 Jan 2;370(1):3-6.
1044
Human embryonic and induced pluripotent stem cell research trends: complementation and diversification of the
field. Kobold S, Guhr A, Kurtz A, Lser P. Stem Cell Reports. 2015 May 12;4(5):914-25.
1045
https://www.nih.gov/about-nih/what-we-do/budget.
1046
83,592 Active Research Projects. https://projectreporter.nih.gov.
1047
228,702 Clinical trials; https://www.clinicaltrials.gov.
1048
For example, see: Some conditions of obedience and disobedience to authority. Milgram S. Int J Psychiatry.
1968 Oct;6(4):259-76; The Tuskegee study of untreated syphilis. Kampmeier RH. South Med J. 1972

373

the rights of patients and provisions for the ethical oversight of research procedures are not
designed to hinder the advance of science, but rather to ensure that the scientific enterprise
more perfectly fulfills its promise to society by advancing efficiently, while also being both just
and ethical.
The goal of the House Select Investigative Panel is not to oppose science, but rather to
determine how best to support science, so that this important work can advance as rapidly as
possible without ethical compromise. To accomplish this goal, it is important that biomedical
research be accurately understood and that obstacles to research are realistically addressed.
Unfortunately, a number of false and misleading assertions have been made regarding the role of
human fetal tissue in modern scientific researchinaccuracies that must be corrected before
progress towards the goal of promoting sound and ethical research can be realized. Moreover, the
results of this Panels investigation suggest that in some cases, aggressive tissue procurement
businesses have created an artificial market for human fetal tissue, even when it is not the most
scientifically powerful or appropriate research model (e.g., for the study of adult-onset diseases,
such as macular degeneration). Facilitating cost-effective and convenient access to the most
appropriate research models requires an accurate view of when human fetal tissue is necessary
and/or advantageous for modern biomedical research.
Below we address common claims regarding the contribution of fetal tissue to modern
biomedical research (Section B) and respond directly to the false and misleading statements
made in Setting the Record Straight: The Unjustifiable Attack on Womens Health Care and
Life-Saving Research; i.e., the Minority report of the House Select Investigative Panel, dated
December 5, 2016 (Section C). We then present an objective analysis of current, long-standing
research programs that utilize human fetal tissue (Section D), concluding with recommendations
for improving access to appropriate scientific models, including (when necessary) human fetal
tissue (Section E).
B. Response to the misleading and false arguments made by scientific societies, medical
societies, and universities
In February, the ranking member of the House Select Investigative Panel, the Honorable
Jan Schakowsky, asked universities, scientific societies and medical societies for assistance in
providing the Panel with information that will further our understanding of the following three
topics (see letter in Exhibit 9.1):
1) Past benefits of fetal tissue research.
2) Potential future benefits that might be gained through continued fetal tissue research.
3) Unique aspects of fetal tissue in research, in comparison with adult cells, stem cells, or
other cellular organisms that might be used for research purposes.

Oct;65(10):1247-51; Experiments at the Willowbrook State School. Krugman S. Lancet. 1971 May 8;1(7706):9667.

374

To date, we have received responses from the following institutions (Exhibit 9.2):
American Academy of Pediatrics (AAP)
American Association for the Advancement of Science (AAAS)
American College of Obstetricians and Gynecologists (ACOG)
Association of American Medical Colleges (AAMC)
Baylor College of Medicine
Childrens Hospital of Pennsylvania (CHOP)
Columbia University
Dartmouth University
Harvard University
John Hopkins University
Oregon Health Sciences University (OHSU)
Rockefeller University
University of California Los Angeles (UCLA)
University of California San Diego (UCSD)
University of Colorado (UCO)
University of Illinois at Chicago (UIC)
University of Minnesota (UMN)
University of Pennsylvania
University of Wisconsin-Madison (UWM)
Yale University
There are a number of reasons why the specific questions posed by the ranking member
have limited value. First, while the past benefits of human fetal tissue research may be of
historical interest, experiments conducted a half-century or more ago are no more relevant to the
practice of modern science than vacuum tube-technology is relevant to modern television
manufacturing. Second, speculation on the potential future benefits of human fetal tissue
research is simply that: speculation. Scientific societies and research universities are no more
capable of predicting the future than anyone else. Finally, while the question of whether human
fetal tissue provides unique benefits to research is important, not a single one of the responding
institutions provided substantive evidence relevant to this question. The issues and arguments
raised in the letters to the Panel fell into eight major areas that are addressed in detail below.
1. Concerns regarding the privacy and safety of researchers involved in human fetal tissue
research
A number of letters (AAAS, Hopkins, UCLA, UCO, UMN) expressed concern that the
investigation of the House Select Investigative Panel would reveal the identities of researchers,
compromising their privacy and potentially putting them at risk for reprisal. Yet this concern
appears to reflect a false belief that publicly funded scientific research is somehow exempt from
the Freedom of Information Act.1049 Moreover, in compliance with the National Institutes of
1049

Freedom of Information Act, 5 U.S.C. 552 et seq. See generally https://www.foia.gov/.

375

Health (NIH) Reform Act of 2006,1050 detailed information on all grants that employ human fetal
tissue is posted on a publicly available website,1051 including the names of the researchers and
links to their publications. Therefore, the scientists involved in human fetal tissue research, as
well as the names and affiliations of their colleagues and collaborators, have already been
identified by the NIH.
2. The false claim that human fetal tissue was used in the last century to produce vaccines
for polio and other diseases
Several letters (AAAS, AAP, ACOG, Columbia, Harvard, OHSU, UCLA, UIC, UWM)
claim that research on fetal tissue was required for production of the polio vaccine. A similar
claim is made by a Guttmacher Policy Review article that states, Fetal Tissue Research dates
back to the 1930s, and has led to major advances in human health, including the virtual
elimination of such childhood scourges as polio, measles and rubella in the United States.1052
However, the facts simply do not support these claims.
a) Early vaccine research did not rely in any way on human fetal tissue
Vaccine research was begun by Edward Jenner in the late 1700s, more than 100 years
before the first published use of human fetal tissue for biomedical research in the 1920s.1053
Jenner developed a vaccine against smallpox in 1798 which ultimately led to the eradication of
this devastating disease. In fact, vaccines against 8 diseases (Rabies, Diphtheria, Typhoid,
Cholera, Plague, Tetanus, Pertussis and Bacille-Calmette-Guerin disease) were all developed in
the 1800s and early 1900s, well before the first use of fetal tissue in research.1054
b) The polio vaccine was not produced using human fetal tissue
Work on the polio virus began in the 1930s, when our knowledge of how to culture
human cells in the laboratory was quite primitive. Polio virus was first successfully propagated
in the laboratory by Albert Sabin in 1936 using human fetal tissue cultures.1055 This early result
was important for advancing our understanding of polio, but did not directly result in a vaccine.
Moreover, human fetal tissue has never been used to make the polio vaccine. Jonas Salk and

1050

National Institutes of Health (NIH) Reform Act of 2006, Pub. L. No. 109-482, 120 Stat. 3675 (2007).
https://projectreporter.nih.gov.
1052
Fetal Tissue Research: A Weapon and a Casualty in the War Against Abortion. Boonstra, HD. Guttmacher
Policy Review 2016 | Vol. 19, http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF0420160302-SD011.pdf.
1053
Addisons Disease, with Severe Anaemia, treated by Suprarenal Grafting. Hurst AF, Tanner WE, Osman AA.
Proc R Soc Med. 1922;15(Clin Sect):19-20.
1054
History of vaccine development. Stanley A. Plotkin, New York : Springer, c2010. See also Immunization Action
Coalition Vaccine Timeline, http://www.immunize.org/timeline/.
1055
Sabin A B, Olitsky P K. Cultivation of poliomyelitis virus in vitro in human embryonic nervous tissue. Proc Soc
Exp Biol Med. 1936;34:357359.
1051

376

Albert Sabin used monkey cells to produce the Polio vaccine,1056 and we are still using monkey
cells to produce this vaccine today.
c) The Nobel Prize was not awarded for curing polio using fetal tissue
The Nobel Prize was awarded to John Enders, Thomas Weller, and Frederick Robbins in
1954 for work on the polio virus that involved human fetal tissue. However, the work of Enders,
Weller and Robbins was not for curing polio, but rather for basic research on the polio virus.
Importantly, this work did not critically depend on the use of human fetal tissue; i.e., we could
have learned everything they discovered about polio using animal cells. Prior to the work of
Enders, Weller and Robbins, people believed polio virus infected human brain tissue, because 1)
this is the tissue most strongly affected in the disease and 2) the only successful propagation of
polio virus in the laboratory used human fetal brain tissue. In their Nobel Prize awarded work,
Enders, Weller and Robbins showed that in fact, polio virus could be harvested from cultures of
multiple human tissues, both fetal1057 and non-fetal.1058
Importantly, the central discovery for which the Nobel Prize was awarded had nothing to
do with the properties of human fetal cells. Rather, the critical finding was that polio virus could
be propagated in a wide range of tissues. This finding paved the way for Salk and Sabin to
culture polio in monkey kidney cells to produce the polio vaccine. However, if Enders, Weller
and Robbins had tried monkey cells or human foreskin fibroblasts before they tried human fetal
tissue, they would have made the same discovery (that polio could be propagated in multiple cell
types), and they still would have won the Nobel Prize for this discovery, without the use of
human fetal cells.
d) The vaccine for Measles was not produced using human fetal tissue
Guttmacher asserts that fetal tissue research resulted in the eradication of measles, yet in
reality, fetal tissue and fetal cell lines were not used for development of the measles vaccine. This
vaccine was developed in 1963 by Peebles and Enders, using chicken eggs, human amnion cells
(obtained from term placentas), and human kidney cultures obtained from adult surgical
samples.1059 The vaccine was tested on monkeys.1060

1056

For a review of the treatment of polio, see Vaccine-derived polioviruses and the endgame strategy for global
polio eradication. Kew OM, Sutter RW, de Gourville EM, Dowdle WR, Pallansch MA. Annu Rev Microbiol.
2005;59:587-635.
1057
Cultivation of the Lansing Strain of Poliomyelitis Virus in Cultures of Various Human Embryonic Tissues.
Enders JF, Weller TH, Robbins FC. Science. 1949 Jan 28;109(2822):85-7.
1058
Cultivation of poliomyelitis virus in cultures of human foreskin and embryonic tissues. Weller TH, Robbins, FC,
Enders JF. Proc Soc Exp Biol Med. 1949 Oct;72(1):153-5.
1059
Milovanovic MB, Enders JF, Mitus A. Cultivation of measles virus in human amnion cells and in developing
chick embryo. Proc Soc Exp Biol Med. 1957;95(1):120127.
1060
Enders JF, Katz SL, Milovanovic MV, Holloway A. Studies on an attenuated measles-virus vaccine. I.
Development and preparation of the vaccine: technics for assay of effects of vaccination. N Engl J Med.
1960;263:153159.

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e) The vaccine for Mumps was not produced using human fetal tissue
The Mumps virus vaccine (MumpsVax) was licensed by Merck in 1967, at roughly the
same time as the vaccine for Measlesa period when it is claimed that human fetal tissue was
necessary for vaccine research and development. However, like polio and measles, production
of the Mumps vaccine did not rely on human fetal tissue. The Mumps vaccine was developed by
Maurice Hilleman, who isolated a wild type virus from his daughter, Jeryl Lynn, who was
recovering from mumps. Hilleman propagated the Mumps Jeryl Lynn strain of virus in three
different animal culture systems: monkey cells, chick embryo fibroblast cells, and embryonated
chicken eggs. The Mumps vaccine is still produced using embryonated chicken eggs today
(Exhibit 9.3).
f) The vaccine for Rubella; an isolated case
Of the diseases commonly used to illustrate the purported use of fetal tissue for the
development of vaccines, Rubella is the single case for which this claim is at least partially
correct. However, fetal tissue was not used to produce the first vaccine for Rubella, and the
subsequent use of fetal tissue to manufacture Rubella vaccine was largely due to historical, not
scientific factors.
Attenuated Rubella virus was first isolated in 1966.1061 The earliest Rubella strains used
for research were obtained by rinsing the throats of infected individuals and propagating the
virus in animal cell culture. Work with these strains led to the development of the first Rubella
vaccines in 1969.1062
Given that human fetal tissue was not used to produce the first Rubella vaccine, what is
the basis for the claim that fetal tissue was necessary for combatting this disease? Beginning in
the 1930s and continuing as late as the 1970s, fetal tissue was often used for propagation of
virus, simply because (at the time) there was limited understanding of how to work with human
cells and fetal tissue is easier to grow in the laboratory. Beginning in the 1960s, several
laboratories were able to chemically alter cells derived from aborted fetuses such that the cells
would continue to divide indefinitely in culture. Two of these transformed cell lines, WI-381063
and MRC-51064 (each derived from a single aborted fetus), proved to be very robust and were
rapidly adopted by many investigators. In addition, one strain of the Rubella virus (RA 27/3) was

1061

Attenuated rubella virus. I. Development and laboratory characterization. Parkman PD, Meyer HM Jr,
Kirschstein RL, Hopps HE. N Engl J Med. 1966 Sep 15;275(11):569-74.
1062
Three rubella virus strains were licensed in the U.S. in 1969.: HPV-77 strain grown in dog-kidney culture
(Rubelogen by Parke-Davis); HPV-77 grown in duck-embryo culture (Meruvax by Merck); and Cendehill strain
grown in rabbit-kidney culture (Cendevax by RIT-SKF, and Lirubel and Lirutrin by Dow). See:
http://www.immunize.org/timeline/
1063
The serial cultivation of human diploid cell strains. Hayflick, L, Moorhead, PS. Exp Cell Res. 1961 Dec;25:585621.
1064
Characteristics of a human diploid cell designated MRC-5. Jacobs JP, Jones CM, Baille JP. Nature. 1970 Jul
11;227(5254):168-70.

378

isolated from an aborted human fetus in 1969,1065 several years after the first isolation of
attenuated Rubella from non-fetal sources and production of the first Rubella vaccine. The RA
27/3 Rubella strain was propagated in fetal-derived cell lines to produce an alternative Rubella
vaccine.
For reasons that are unrelated to the fetal origin of the virus, the RA 27/3 strain proved to
be very effective in eliciting a strong immune response, and earlier forms of the Rubella vaccine
were abandoned. Consequently, the RA 27/3 strain (propagated in fetal-derived cell lines) is still
used for production of Rubella vaccine today.1066 But importantly, the Rubella vaccine developed
using fetal tissue was not the first or the only Rubella vaccine produced. In contrast to the claims
noted above, human fetal tissue was not required for isolation and propagation of Rubella or
for development of vaccines against this disease, even in the 1960s.
3. False claims that the production of modern vaccines depends on human fetal tissue
Several letters (AAMC, AAP, ACOG, CHOP, Columbia, Dartmouth, Harvard, OHSU,
Rockefeller, UCLA, UIC, UMN, UWM, Yale) suggest that human fetal tissue is used for modern
vaccine production. In reality, none of the nearly 75 vaccine formulations currently licensed in
the United States is produced using human fetal tissue (see Exhibit 9.3).
a) Historic use of fetal cell lines in vaccine production by pharmaceutical companies
The fetal-derived cell lines WI-38 and MRC-5 were adopted by the pharmaceutical
industry as tools for the production of vaccines shortly after they were developed in the 1960s.
And for a small minority of vaccines, these tools are still used today. However, these historic
fetal-derived cell lines are still in use today for primarily economic, not scientific reasons.
Obtaining FDA approval for a new vaccine is very labor intensive and costly.
Consequently, once FDA approval has been secured for a particular method of producing a
vaccine, Pharmaceutical companies tend to rely on this method, to avoid incurring new costs
associated with validating the safety and efficacy of new procedures. Three major
Pharmaceutical players (Merck, GlaxoSmithKline and Sanofi) adopted the fetal cell lines MRC-5
and WI-38 in the 1970s, shortly after they were developed. These companies were successful in
gaining FDA approval for vaccines produced in these cell lines, and have continued using them
ever since. However, viable alternatives exist and are used by other pharmaceutical companies
for production of very similar vaccines (see Exhibit 9.3).

1065

Attenuation of RA 27-3 rubella virus in WI-38 human diploid cells. Plotkin SA, Farquhar JD, Katz M, Buser F.
Am J Dis Child. 1969 Aug;118(2):178-85.
1066
See: Plotkin SA. The History of Rubella and Rubella Vaccination Leading to Elimination. Clin Infect Dis. 2006
43 (Supplement 3): S164-S168.

379

b) Modern vaccine production and research

Of the nearly 75 vaccine formulations currently approved by the Food and Drug
Administration for use in the United States,1067 only 11 (directed against Zoster, Varicella,
Rabies, Rubella, Hepatitis A, Polio and Adenovirus) are produced using historic, fetal-derived
cell lines, and none are produced using freshly isolated fetal tissue. Importantly, alternative
vaccine formulations that do not rely on fetal-derived cell lines are available or all but five of
these diseases (Adenovirus, Hepatitis A, Rubella, Varicella and Zoster), and there is no scientific
reason these vaccines could not be produced using animal cell lines. For example, although
vaccines against Hepatitis A are produced using the historic fetal-derived cell line MRC-5,
modern vaccines against the related Hepatitis B virus are produced using genetically engineered
yeast cells. In fact, the vast majority of modern vaccines are manufactured using bacteria, yeast
or animal cellsand all of them could be manufactured in this manner. Human fetal tissue is
outdated technology that is not necessary for modern vaccine production or research. For
example, current vaccine research for HIV/AIDS, Cancer, Malaria and Ebola does not rely on
human fetal tissue (see Exhibit 9.3.).
4. Assertions that fetal tissue is necessary for the study of diseases that affect human brain
development, including Zika and Down syndrome
Several institutions (AAAS, ACOG, CHOP, Columbia, Harvard, Hopkins, Rockefeller,
UCLA, UIC, UMN, Penn and Yale) claim that human fetal tissue is required for study of human
development, particularly brain development and human brain diseases, such as Zika and Down
syndrome. Yet given the strong similarities between neural development in humans and in other
mammalian species, this assertion is largely unwarranted. For example, less than 1% of the more
than twenty thousand research articles returned by querying the NIH-maintained PubMed
database1068 for the term neurogenesis involve human fetal tissue. Moreover, the history of
vaccine development for Cytomegalovirus (CMV), one of the most compelling parallels to the
Zika virus, provides a clear illustration of why human fetal tissue is not required for the study of
viruses that affect brain development.
The Zika virus has received a lot of attention, with many characterizing it as a health
crisis and calling for immediate actionincluding expanded fetal tissue research to develop a
vaccine and reduced restrictions on abortion to eliminate infected infants prior to birth.
And Zika is indeed an alarming virus. The Centers for Disease Control (CDC) estimates
that if a woman is infected with Zika in the first trimester of pregnancy, there is a 1-13% risk that
her child will be born with a serious brain defect, including microcephaly.1069 Moreover, a recent

1067

FDA approved vaccine formulations:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm.
1068
https://www.ncbi.nlm.nih.gov/pubmed.
1069
http://www.nejm.org/doi/pdf/10.1056/NEJMp1605367.

380

study from Brazil,1070 and a report by the CDC1071 both suggest that Zika increases the risk of
miscarriage, even for healthy infants who are not affected by the virus.
Understandably, Zika has become the focus of an intense research effort, with nearly 120
clinical and research articles published on the virus, most within the last few years.1072
Importantly, only two of these have involved the use of fetal tissue.1073 The major advances in
our understanding of the Zika virus, published in world-renowned scientific journals such as
Lancet, The New England Journal of Medicine, Science, and Nature, have not relied on the use
of human fetal tissue at all.
Zika has only recently become the subject of intense scientific investigation, and
therefore the potential role of human fetal tissue in this research is hard to predict. Yet Zika isnt
the only virus that causes brain defects and miscarriage. Comparing Zika to similar viruses that
have been investigated for a longer time provides a better measure of whether human fetal tissue
is likely to be important in combatting this type of disease. And the best studied virus that affects
brain development in a manner quite similar to Zika is Cytomegalovirus, or CMV.
Similar to Zika, if a mother becomes infected with CMV during the first trimester of her
pregnancy, there is a 9% risk that her child will be born with a serious brain defect, including
microcephaly (Fig. 1).1074 Also similar to Zika, the effects of CMV on adults are mild, making it
difficult for a pregnant woman to know for sure that she has been infected. Yet unlike Zika,
CMV is a very prevalent virus, with an estimated 30-50% of women of childbearing age worldwide being infected.1075 Consequently, the toll of CMV on women and their children is far
greater than for Zika. The CDC estimates that 1 in every 750 children born in the United States,

1070

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1602412.
http://www.cdc.gov/mmwr/volumes/65/wr/mm6508e1.htm.
1072
Based on a search of the NIH PubMed database (http://www.ncbi.nlm.nih.gov/pubmed) using the following
terms: (zika virus AND ((case reports[Publication Type] OR clinical study[Publication Type] OR clinical
trial[Publication Type] OR clinical trial, phase i[Publication Type] OR clinical trial, phase ii[Publication Type]
OR clinical trial, phase iii[Publication Type] OR clinical trial, phase iv[Publication Type] OR comparative
study[Publication Type] OR controlled clinical trial[Publication Type] OR meta analysis[Publication Type]
OR research support, american recovery and reinvestment act[Publication Type] OR research support, n i h,
extramural[Publication Type] OR research support, n i h, intramural[Publication Type] OR research support,
non u s govt[Publication Type] OR research support, u s govt, non p h s[Publication Type] OR research
support, u s govt, p h s[Publication Type] OR research support, u s government[Publication Type])) NOT
review[Publication Type].
1073
Zika Virus Infection with Prolonged Maternal Viremia and Fetal Brain Abnormalities. Driggers RW, Ho CY,
Korhonen EM, Kuivanen S, Jskelinen AJ, Smura T, Rosenberg A, Hill DA, DeBiasi RL, Vezina G, Timofeev J,
Rodriguez FJ, Levanov L, Razak J, Iyengar P, Hennenfent A, Kennedy R, Lanciotti R, du Plessis A, Vapalahti O. N
Engl J Med. 2016 Jun 2;374(22):2142-51. doi: 10.1056/NEJMoa1601824; The Brazilian Zika virus strain causes
birth defects in experimental models. Cugola FR, Fernandes IR, Russo FB, Freitas BC, Dias JL, Guimares KP,
Benazzato C, Almeida N, Pignatari GC, Romero S, Polonio CM, Cunha I, Freitas CL, Brando WN, Rossato C,
Andrade DG, Faria Dde P, Garcez AT, Buchpigel CA, Braconi CT, Mendes E, Sall AA, Zanotto PM, Peron JP,
Muotri AR, Beltro-Braga PC. Nature. 2016 May 11;534(7606):267-71. doi: 10.1038/nature18296.
1074
http://www.ncbi.nlm.nih.gov/pubmed/23297260; http://www.ncbi.nlm.nih.gov/pubmed/19800841.
1075
CDC, Cytomegalovirus (CMV) and Congenital CMV Infection, http://www.cdc.gov/cmv/trendsstats.html#affected.
1071

381

or over 5000 children each year, suffer permanent problems caused by CMV infection.1076 CMV
is clearly a health crisis for women and for children that is just as serious, if not more serious,
than Zika.
So what are we doing about the CMV crisis? Shockingly, very little. We have known
about CMV for over 100 years; the virus was
Figure 1: Microcephaly caused by CMV (top) and
originally isolated in the 1950s,1077 but
by Zika (bottom).
researchers have been aware of its effects on
unborn children from as early as 1881.1078
Since the 1950s, we have developed vaccines
against measles, mumps, and a host of other
viral diseases. Yet, despite many attempts, an
effective vaccine against CMV has not been
produced. And in the 60 years since the
CMV virus was isolated, hundreds of
thousands of American children with severe
brain defects have been born, lived, and died,
largely ignored by the media and by
politicians.
CMV is truly one of the darkest
stories in modern medicine. But thankfully,
the story has recently been brightened by a
glimmer of hope. Several candidate vaccines
have been developed and are currently being
tested in clinical trials, with promising
results.1079 After decades of disappointment,
we may be close to preventing this
devastating disease.
After so many years of fruitless effort, what has turned the tide on CMV? Perhaps
surprisingly in the face of repeated claims that human fetal tissue is necessary to develop a
cure for viruses that disrupt brain development, fetal tissue has made almost NO contribution to
modern CMV vaccine research (Figure 2). Between 2010 and 2014 the NIH awarded over 75
grants focused on finding a vaccine to prevent CMV, and only one involved human fetal
tissue.1080 Similarly, there are 53 ongoing clinical trials of CMV-vaccines, and not a single one
involves the use of human fetal tissue.1081 The break-through on this devastating disease did not
depend on human fetal tissue research at all.
1076

Id.
http://www.ncbi.nlm.nih.gov/pubmed/9042169.
1078
Id.
1079
http://www.ncbi.nlm.nih.gov/pubmed/25791890.
1080
Based on a search of the NIH grant database (https://projectreporter.nih.gov) over the years 2010-2014 for the
terms congenital cytomegalovirus, vaccine related and human fetal tissue.
1081
Based on a search of the NIH clinical trials database (https://www.clinicaltrials.gov) for the terms CMV
vaccine and fetal tissue.
1077

382

Figure 2: Modern CMV research.

The breakthrough on a CMV vaccine came from

basic scientific research using animal models, human
cell lines, and adult human tissue. Scientists working
with adult blood cells in the 1990s discovered a
protein complex that was important for CMV
infection.1082 It was later discovered that in women
with natural immunity to CMV, this same complex
was the target of antibodies that effectively
neutralized the virus.1083 These findings led to
successful vaccination experiments in animals1084 that
have rapidly lead to similar human clinical trials.1085

So what can we learn from CMV, a virus that is parallel in many ways to Zika? First, as
frightening as Zika is, it is not a health care crisis, unless we are willing to admit we have been
living with a largely ignored CMV crisis for the last 60 years. It is certainly true that both Zika
and CMV take a heavy toll on children and families. They should both be fought aggressively
with the best possible science and medicine. But hysterical calls for enhanced fetal tissue
research and expanded abortion license are a matter of POLITICS, not medicine or science.
Second, developing an effective vaccine is sometimes a very difficult task. We know
more about virology now than we did in the 1950s, but until very recently, CMV has resisted
even our best modern efforts. We need to take a sober view of science and medicine, and accept
that an effective, preventative vaccine for both CMV and Zika may be difficult to achievenot
because of any restrictions that may be placed on fetal tissue research, but because not every
disease is easy to prevent.
Finally, we need to develop a more sophisticated view of how science and medicine
actually work. The promising candidates for a CMV vaccine did not depend on fetal tissue
research. They depended on observations of the natural human immune response and analysis of
the CMV virus in cell lines and animals. We dont need human fetal tissue to develop a vaccine
for Zika, and based on our modern experience with CMV, human fetal tissue is unlikely to
provide a significant advantage in this fight (See Figure 2). The ethical research tools we have in
hand are the best weapons against Zika, even if it proves to be as tenacious and confounding as
CMV.
5. Assertions that human fetal tissue is vital for a wide range of life-saving research
Several letters (AAAS, CHOP, Dartmouth, Hopkins, OHSU, Rockefeller, UCLA, UCSD,
UIC, UMN, Penn, UWM, Yale) voiced the opinion that human fetal tissue is essential (or
critical or vital) for a wide range of scientific investigations, often expressing alarm that
1082

http://www.ncbi.nlm.nih.gov/pubmed/8397282.
http://www.ncbi.nlm.nih.gov/pubmed/19889756.
1084
http://www.ncbi.nlm.nih.gov/pubmed/24297878; www.ncbi.nlm.nih.gov/pubmed/23107592.
1085
E.g., NCT00722839; NCT00439803.
1083

383

cures would be delayed or prevented if human fetal tissue were not available for research. The
same concerns were raised by Dr. Lawrence Goldstein in his March 2, 2016, testimony before
the House Select Investigative Panel.1086 Goldstein indicated that human fetal astrocytes are
vital for his research on Alzheimers disease and cannot be replaced by astrocytes derived
from non-fetal or animal sources.
Yet all of these interlocutors fail to note that human fetal tissue research represents only a
tiny fraction of the overall scientific enterprise. For example, of the 76,081 research grants
funded by the NIH in 2014, only 160 (or approximately 0.2%) involved human fetal tissue.1087 In
the case of Alzheimers disease specifically (the area of research singled out by Dr. Goldstein), a
total of 1304 grants investigating Alzheimers disease were awarded in 2014, and not a single
one involved fetal tissue.1088 Clearly, the overwhelming majority of active, funded, research
scientistsand the much larger number of their scientific peers who reviewed and endorsed
these proposals for fundinghave concluded that human fetal tissue is not vital for modern
research on either Alzheimers disease or other scientific questions.
This fact raises a serious conundrum for those who claim human fetal tissue research is
essential for advancing modern research. Given that the purpose of scientific peer review is to
identify research proposals that use the most appropriate and powerful methods to address the
most important scientific questions, why have the great majority of scientists elected not to
employ human fetal tissue in their own research, and why have their scientific peers
overwhelmingly endorsed this decision? Dr. Goldstein simply ignores this inconvenient reality,
and presents his own minority opinion as if it reflected the view of the scientific community as a
whole.
Dr. Goldstein also raises a second example of how human fetal tissue is vital for
research, indicating that he uses such tissue in his attempt to build new kidneys from stem
cells, categorically asserting it is only by examining this fetal tissue that it will be possible to
determine the earliest biochemical signals that cells use . . . to make kidneys (emphasis added).
Yet Goldstein fails to note that substantial progress towards the goal of generating replacement
kidneys has already been accomplished in other laboratories using stem cells from non-fetal
sources.1089 While Dr. Goldstein has clearly placed his faith in human fetal tissue research, his
competitors have moved much more swiftly towards the goal of generating replacement organs

1086

Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., at 149 (unedited transcript) (Mar. 2, 2016) (Testimony of Lawrence Goldstein),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Wstate-GoldsteinL-20160302.pdf.
1087
https://projectreporter.nih.gov.
1088
A search of the NIH database of funded research (https://projectreporter.nih.gov) for 2014 using the NIH
spending categories Alzheimers Disease and Human Fetal Tissue returned two projects: one core facility
(P50 award) that does not specifically generate research on Alzheimers and one award that mentions Alzheimers
Disease, but is in fact focused on Down syndrome.
1089
Generation of kidney organoids from human pluripotent stem cells. Takasato M, Er PX, Chiu HS, Little MH.
Nat Protoc. 2016 Sep;11(9):1681-92.; Kidney organoids from human iPS cells contain multiple lineages and model
human nephrogenesis. Takasato M, Er PX, Chiu HS, Maier B, Baillie GJ, Ferguson C, Parton RG, Wolvetang EJ,
Roost MS, Lopes SM, Little MH. Nature. 2016 Apr 27;536(7615):238.

384

using an ethically uncontroversial approach. And for patients, actual results are undoubtedly far
more compelling than Dr. Goldsteins personal ideology.
Finally, consistent with the view that fetal tissue is essential for research, tissue
procurement companies such as StemExpress market cells derived from fetal tissue as valuable
scientific reagents, often charging thousands of dollars for a single preparation.1090 Yet all of the
cell types obtained from human fetal liver by StemExpress can be obtained from alternative
sources (placenta, umbilical cord and umbilical cord blood); including CD34+ cells,1091 CD36+
cells,1092 CD133+ cells,1093 and stromal (mesenchymal) stem cells.1094 While some individual
scientists (such as Dr. Goldstein) may believe that fetal cells are somehow superior to cells
with the same characteristics that have been isolated from other sources, fetal cells clearly do not
have unique properties. The role of tissue procurement companies in creating a market for
cells derived from human fetal tissue is difficult to determine, but it is obvious that a wide range
of stem and progenitor cells can be obtained from ethically uncontroversial tissue sourcesand
from sources that are often more relevant to the study of adult or neonatal disease than cells
derived from fetal tissue.
6. Claims that human fetal tissue is required for clinical trials and cures
Several institutions (AAAS, Hopkins, Rockefeller, UCLA, UCSD, UIC, Yale) make this
claim. In support of this view, Dr. Goldstein correctly notes in his March 2 testimony before the
House Select Investigative Panel1095 that neural stem cells derived from fetuses are currently
being tested in clinical trials. He further suggests that medical treatments will be halted or
delayed if fetal tissue is not available for research. A similar claim was made by the Guttmacher
Policy Review, which states, Clinical trials transplanting fetal cells are currently underway for
people with spinal cord injury, stroke and ALS (Lou Gehrigs disease), and may soon begin for
those with Alzheimers disease, Parkinsons disease and multiple sclerosis.1096

1090

StemExpress website on fetal liver, http://stemexpress.com/product-category/fetal-liver/.

A novel method of CD34+ cell separation from umbilical cord blood. Mehrishi JN, Bakcs T. Transfusion. 2013
Nov;53(11):2675-80.
1092
Extensive ex vivo expansion of functional human erythroid precursors established from umbilical cord blood
cells by defined factors. Huang X, Shah S, Wang J, Ye Z, Dowey SN, Tsang KM, Mendelsohn LG, Kato GJ,
Kickler TS, Cheng L. Mol Ther. 2014 Feb;22(2):451-63.
1093
Isolation and characterization of CD133+CD34+VEGFR-2+CD45- fetal endothelial cells from human term
placenta. Slder E, Bckle BC, Nguyen VA, Frhapter C, Obexer P, Erdel M, Stssel H, Romani N, Sepp NT.
Microvasc Res. 2012 Jul;84(1):65-73.
1094
Novel isolation strategy to deliver pure fetal-origin and maternal-origin mesenchymal stem cell (MSC)
populations from human term placenta. Patel J, Shafiee A, Wang W, Fisk NM, Khosrotehrani K. Placenta. 2014
Nov;35(11):969-71.
1095
Bioethics and Fetal Tissue: Hearing Before the Select Investigative Panel, H. Comm. on Energy and Commerce,
114th Cong., at 149 (unedited transcript) (Mar. 2, 2016) (Testimony of Lawrence Goldstein, at 110),
http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF04-Wstate-GoldsteinL-20160302.pdf
1096
Fetal Tissue Research: A Weapon and a Casualty in the War Against Abortion. Boonstra, HD. Guttmacher
Policy Review 2016 | Vol. 19, http://docs.house.gov/meetings/IF/IF04/20160302/104605/HHRG-114-IF0420160302-SD011.pdf.
1091

385

a) Fetal tissue is used in only a tiny fraction of clinical trials

Goldstein, Guttmacher, and the institutions noted above all fail to mention that human
fetal tissue contributes to only a tiny fraction of the over 230 thousand clinical trials currently
underway in the United States and around the world.1097 A detailed examination of the studies
indexed in the NIH database for clinical trials determined that there are currently only 7 studies
involving transplantation of fetal tissue into patients (See Exhibit 9.4). Similarly, there are only
35 trials involving stem cell lines originally derived from human embryonic or fetal tissue (See
Exhibit 9.4). Of these, a surprisingly large number (seven trials; 20%) have been withdrawn,
suspended, or terminatedmore than twice the rate seen for clinical studies using non-fetal stem
cells.1098 Together, these 42 fetal or embryonic stem-cell studies account for only 0.01% of all
ongoing clinical trials. Clearly, the vast majority of scientists and physicians developing new
treatments for human disease do not rely on either human fetal tissue or stem-cell lines derived
from human fetuses.
Importantly, fetal tissue has been used in clinical research since the 1920s,1099 yet in
nearly 100 years of unrestricted research, not a single clinical treatment has been developed from
human fetal tissue. Even worse, there are currently only a handful of studies investigating the use
of fetal tissue or fetal-derived cells, most of which are in very early (phase I) clinical trials that
have not yet shown any benefit to patients. Fetal tissue research has had ample time to prove
itself clinically useful and has failed to do so. The evidence clearly indicates that fetal tissue
research is outdated technology that is largely ignored in by the clinical research enterprise
because it has shown no benefit to patients.
b) Non-fetal stem cells have consistently shown much greater clinical promise than
fetal stem cells
As noted above, human fetal tissue has been the subject of clinical and scientific research
since the 1920s, yet in modern research, fetal tissue is primarily used as a source of stem and
progenitor cells. Similar cells exist in multiple adult and birth-related tissues, yet they have only
recently become the subject of active clinical investigation. For example, while scientists
appreciated the existence of stem cells in bone marrow as early as the 1930s,1100 bone marrow

1097

Based on the Clinical Trials website; Queried 11/22/2016; www.clinicaltrials.gov.

Overall, 8.1% of all studies listed in the Clinical Trials database have been terminated, suspended, or withdrawn
(18,868 of 230, 631 as of 11/22/2016). A slightly higher number of studies involving non-fetal stem cells have been
prematurely terminated (635 of 5805; 10.9%). Studies can be ended prematurely for a number of reasons, including
insufficient recruitment of patients, futility (no positive results), clear benefit to patients or harm to patients. A
recent analysis indicates that three factors (insufficient recruitment, futility and harm) account for 82% of premature
terminations. See Premature trial discontinuation often not accurately reflected in registries: comparison of registry
records with publications. Alturki R, Schandelmaier S, Olu KK, von Niederhusern B, Agarwal A, Frei R,
Bhatnagar N, Hooft L, von Elm E, Briel M. J Clin Epidemiol. 2016 Sep 7. pii: S0895-4356(16)30403-6
1099
Op cit. Hurst AF, Addison's Disease, 1922.
1100
Based on the PubMed database, the first paper with the phrase stem cell in the title or abstract was published
in 1932; The production of osteogenic sarcomata and the effects on lymph nodes and bone marrow of intravenous
infections of radium chloride and mesothorium in rabbits. Sabin FR, Doan CA, Forkner CE. J Exp Med. 1932 Jul
31;56(2):267-89.
1098

386

from an unrelated donor was not used for a medical transplant until 1968,1101 more than four
decades after the first fetal tissue transplant. The first non-fetal stem cells from tissue other than
bone marrow (satellite cells from muscle) were not isolated until 1986.1102 Finally, multi-lineage
progenitor cells were first isolated from adult adipose tissue in 2001,1103 and these cells proved to
be so medically promising, they were used in clinical trials a mere four years later.1104 Despite
the relatively recent isolation of non-fetal stem cells from bone marrow, fat and other tissues,
they are currently being tested in over 5,800 clinical trials for a wide range of human disease,
including diabetes, Parkinsons, multiple sclerosis, heart disease and cancer. Hundreds of studies
using non-fetal stem cells have already advanced to phase II and phase III trials because they
have shown clear benefit to patients.1105
c) Conclusion
In over 100 years of unrestricted research, fetal tissue has not proven to be useful for
treating human disease. In contrast, although stem and progenitor cells from non-fetal tissues
have only recently been discovered, they have rapidly yielded clinical treatments with proven
benefit to patients. The alarmist claims that restrictions on human fetal tissue research would
somehow delay or prevent the development of cures are entirely unfounded.
7. Assertions that human fetal tissue is required for production of humanized mice that
provide a model for human diseases with a restricted host range
Several universities (Baylor, Columbia, Dartmouth, Harvard, Hopkins, OHSU,
Rockefeller, UCLA, UIC, UMN, UWM) claim that human fetal tissue is necessary to create
humanized mice disease models. In the most extreme example of this research model, human
fetal progenitors from blood, liver, and thymus are used to create a BLT mouse that
reconstitutes many aspects of the immature human immune system.
However, humanized mice can be produced using a variety of more mature tissues,
including progenitors from adult peripheral blood and from umbilical cord.1106 Different methods
of generating humanized mice have both advantages and disadvantages, with no single method
being clearly superior.1107 While there may be some scientific advantages to the use of human
1101

Gatti RA, Meuwissen HJ, Allen HD, et al. Immunological reconstitution of sex-linked lymphopenic
immunological deficiency. Lancet. 1968 Dec 28. 2(7583):1366-9.
1102
Bischoff R. 1986. Proliferation of muscle satellite cells on intact myofibers in culture. Dev Biol. 115:129139.
1103
Zuk, P.A., Zhu, M., Mizuno, H., Huang, J., Futrell, J.W., Katz, A.J., Benhaim, P., Lorenz, H.P.,
and Hedrick, M.H. (2001). Multilineage cells from human adipose tissue: implications for cell based therapies.
Tissue Eng 7, 211-228.
1104
Garca-Olmo D, Garca-Arranz M, Herreros D, Pascual I, Peiro C, Rodrguez-Montes JA. A phase I clinical trial
of the treatment of Crohns fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum.
2005;48(7):14161423.
1105
A query of Clinical Trials website returns over 700 phase II and phase III trials involving non-fetal stem cells.
Queried 10/28/2016; www.clinicaltrials.gov.
1106
Reviewed in: Increasing hematopoietic stem cell yield to develop mice with human immune systems. Biancotti
JC, Town T. Biomed Res Int. 2013;2013:740892.
1107
Humanized mice for immune system investigation: progress, promise and challenges. Shultz LD, Brehm MA,
Garcia-Martinez JV, Greiner DL. Nat Rev Immunol. 2012 Nov;12(11):786-98.; Improvements and Limitations of

387

fetal tissue in some experimental settings, fetal tissue is clearly not required for production of
humanized mice. Moreover, this is a rapidly evolving technology, with many avenues as yet
unexplored. For example, it is unclear whether fetal liver and thymus are required to produce
BLT mice. Recent work indicates thymic tissue is functional throughout adult life, 1108 and
postnatal thymic tissue has been used to reconstitute immune function in human patients,1109
strongly suggesting that human fetal thymus may not be required for the BLT-mouse model.
8. Assertions that human fetal tissue is required to validate scientific findings obtained
with human embryonic stem cells (hESCs) or human induced pluripotent stem cells
(hiPSCs)
Several universities (Columbia, UCLA, Penn, and Yale) make this assertion, but it is
unsupported by the scientific literature. Only a tiny fraction of all papers indexed in PubMed on
the topic of cellular reprogramming also examine fetal tissue. Moreover, the use of iPSCs has
grown dramatically since this technology was pioneered in 2007,1110 yet despite the claim that
human fetal tissue is required to validate iPSCs, there has been no corresponding growth in the
use of human fetal tissue over this period.
Although the same assertions have been put forward by multiple institutions and
individuals, these claims have no factual support. To date, the Panel has received no evidence
from scientific societies, medical societies, research universities, or individual scientists
supporting the conclusion that human fetal tissue research provides unique scientific information
or that this research is important for the development of new treatments for human disease.
C. Response to the claim that The Select Panel Has Thwarted Life-Saving Research
The Minority report of the House Select Investigative Panel, dated December 5, 2016
(hereafter, the Minority Report), boldly states that Select Panel Republicans have conducted
an end-to-end attack on fetal tissue donation and research (p. 12) and have roundly rejected or
ignored the evidence for the value of this research, concluding:
In reality, the Panel has received overwhelming evidence of the
indispensable role that fetal tissue research plays in advancing our
understanding and treatment of a staggering array of conditions that

Humanized Mouse Models for HIV Research: NIH/NIAID "Meet the Experts" 2015 Workshop Summary. Akkina
R, Allam A, Balazs AB, Blankson JN, Burnett JC, Casares S, Garcia JV, Hasenkrug KJ, Kashanchi F, Kitchen SG,
Klein F, Kumar P, Luster AD, Poluektova LY, Rao M, Sanders-Beer BE, Shultz LD, Zack JA. AIDS Res Hum
Retroviruses. 2016 Feb;32(2):109-19.
1108
The role of the thymus in immune reconstitution in aging, bone marrow transplantation, and HIV-1 infection.
Haynes BF, Markert ML, Sempowski GD, Patel DD, Hale LP. Annu Rev Immunol. 2000;18:529-60.
1109
Transplantation of thymus tissue in complete DiGeorge syndrome. Markert ML, Boeck A, Hale LP, Kloster AL,
McLaughlin TM, Batchvarova MN, Douek DC, Koup RA, Kostyu DD, Ward FE, Rice HE, Mahaffey SM, Schiff
SE, Buckley RH, Haynes BF. N Engl J Med. 1999 Oct 14;341(16):1180-9.
1110
Human embryonic and induced pluripotent stem cell research trends: complementation and diversification of the
field. Kobold S, Guhr A, Kurtz A, Lser P. Stem Cell Reports. 2015 May 12;4(5):914-25.

388

afflict millions of people in this country and throughout the world.

[emphasis added]
In support of this conclusion, the Minority Report identifies 10 medical conditions that it
claims have benefited from human fetal tissue research. Yet for each of these conditions, the
overwhelming evidence amounts to nothing more than unsupported assertions made by
universities, scientific societies and individual scientists that have been uncritically repeated in
the Minority Report, seemingly as an act of blind faith in scientific authorities.
While appealing to authority can sometimes be a valid way to formulate an opinion, the
views of individual scientists who personally conduct human fetal tissue research (and of the
institutions that employ such individuals) are clearly subject to conflict of interest. When such
views are also unaccompanied by any form of factual evidence, they have even less credibility.
Yet when such personal opinions are also manifestly contradicted by the available evidence, they
must (at minimum) be dismissed as groundless, and (at worst) be seen as a deliberate attempt to
distort the facts out of self-interest or ideological conviction.
We have already addressed in detail the false and misleading arguments put forward in
letters to the panel (Chapter 9.B). Here, we specifically address the claims made in the Minority
Report and demonstrate that publicly available evidence1111 clearly establishes the claims made
in the report are false. Below, we discuss each of these claims in light of the evidence and
conclude by presenting factual data on the use of fetal tissue in NIH-funded disease research,
FDA-approved clinical trials and in the peer-reviewed scientific literature.
1. Alzheimers
The Minority Report begins by solemnly reminding us that Alzheimers is a serious
disease (p. 13). We agree. However, the report uncritically repeats the assertion made by Dr.
Lawrence Goldstein that fetal tissue is the gold standard for Alzheimers research. As noted in
Chapter 9.B.5 of this report, the facts simply do not support Dr. Goldsteins opinion on this
matter or justify the unquestioning faith the Minority Report appears to have placed in the
veracity of his assertion. In reality, of the 1300 research grants investigating Alzheimers
awarded in 2014 and the over 1900 ongoing clinical trials testing possible treatments for
Alzheimers, not a single one uses fetal tissue.1112 While Dr. Goldstein may personally believe
human fetal tissue is the gold standard for research, the vast majority of his scientific
colleagues, as well as the NIH and the FDA clearly do not share this opinion.

1111

Including: the funded grant database maintained by the National Institutes of Health
(www.projectreporter.nih.gov), the clinical trials database maintained by the NIH and the Food and Drug
Administration (www.clinicaltrials.gov), and the PubMed database of peer-reviewed scientific research maintained
by the NIH and the National Library of Medicine (www.ncbi.nlm.nih.gov/pubmed).
1112
A search of the NIH database of funded research (https://projectreporter.nih.gov) for 2014 using the NIH
spending categories Alzheimers Disease and Human Fetal Tissue returned two projects: one core facility
(P50 award) that does not support a specific research program and one award that mentions Alzheimers Disease,
but is in fact focused on Down syndrome. A search of the clinical trials database (www.clinicaltrials.gov) for the
term fetal and the medical condition Alzheimers returned no studies.

389

2. Amyotrophic lateral sclerosis (ALS)

The Minority Report also reminds us that ALS is a serious disease (p. 13), and again, we
agree. Just as for Alzheimers, the report uncritically repeats assertions made by Johns Hopkins
University and UCLA that fetal research is somehow important for developing a cure for ALS.
Yet in reality, there is no evidence to support this assertion. Of the 360 ongoing clinical trials for
ALS, only a single study involves transplantation of human fetal tissue (NCT01640067). This
trial, completed in December of 2015, was an early, phase I study that has thus far neither
advanced to a phase II trial nor published any results. Thus, despite the hyperbolic claim that
fetal tissue has already resulted in promising developments with regards to potential ALS
treatments (p. 14), there are no clinical findings in support of this claim.
The study of a new drug for ALS noted by Johns Hopkins is most likely to be the phase I
trial of GM604, or Genervons Master Regulator 604 (NCT01854294). The Minority Report
repeats Johns Hopkins glowing characterization of this research as so promising for a potential
ALS treatment that the FDA has approved an investigational new drug application for early stage
clinical trials (p. 14). Yet a comprehensive report on the GM604 trial by ALSUntangled
(www.alsuntangled.com),1113 a patient advocacy group and information resource, assigns this
trial three D scores (the second lowest) and two U or unranked scoresindicating that
there is insufficient information to make a valid judgment regarding the quality of the trial. They
note that there is only a single possibly relevant publication using this drug in a mouse model
of stroke (not ALS), with no peer-reviewed studies supporting the many claims made regarding
GM604 on the Genervon web site. The report concludes:
At this time, ALSUntangled finds no independently verifiable data
supporting the efficacy or even the safety of GM604 in patients with
ALS. We believe that independent peer review and replications are
fundamentals of good science.
The Republican members of the Panel agree.
3. Diabetes Mellitus (DM)
Once again, the Minority Report reminds us that Diabetes is also a serious disease (p. 14).
The report repeats the assertions of Harvard and Johns Hopkins Universities that fetal tissue is
important for the study of DM and the complications of this disease, including diabetic
retinopathy. Yet there is a difference between assertion and evidence. Not only do Harvard and
Johns Hopkins fail to report any evidence in support of their assertions; the objective facts
largely contradict their conclusion. For example, in 2014, the NIH funded 2,332 research grants
on the topic of diabetes and related diseases, and only 4 of these grants (less than 0.2%) involve
human fetal tissue; one exploratory (R21) grant, a Postdoctoral fellowship award (F32) and
two investigator initiated (R01) grants.1114 While these projects report modest scientific results
(an average of 1.2 scientific papers/grant/year), they are clearly not at the forefront of the field in

1113

ALSUntangled No. 34: GM604. Amyotroph Lateral Scler Frontotemporal Degener. 2016 Oct - Nov;17(78):617-621.
1114
Based on the NIH database: https://projectreporter.nih.gov/.

390

terms of productivity or impact. Based on the actual evidence, it is hard to see how the Minority
Reports claim that human fetal tissue research makes a significant impact on DM is justified.
Similarly, of the 11,398 current clinical trials for childhood diabetes, only one
(NCT02239354) involves human fetal tissue.1115 Similar to the GM604 trial discussed above, this
DM study is an early, phase I trial with no reported results, and therefore the promise (or lack
of promise) of this approach cannot be evaluated. However, the fact that fetal tissue contributes
to only a single trial out of over 11-thousand clearly indicates that the overwhelming majority of
physicians and scientists working to relieve diabetes patients of the daily finger pricks and
insulin injections they need to stay alive (p. 14) simply do not share the opinion voiced by
Harvard and Johns Hopkins that fetal tissue is important for basic and clinical research into this
disease.
4. HIV/AIDS
The Minority Report quotes three institutions (the University of Minnesota, Oregon
Health and Science University, and the International Society for Stem Cell Research), all of
which assert that fetal tissue research has provided significant benefit to HIV patients. It also
repeats an assertion made by Dr. Brooks Jackson of the University of Minnesota that fetal tissue
was critical in my research to develop an intervention to prevent mother-to-child transmission
of HIV. That research alone has saved over 1 million infants in the last ten years while also
reducing elective abortion in HIV positive women by more than half in this country. Dr.
Jackson makes this assertion despite the fact that a query of the PubMed database1116 does not
return a single paper using fetal tissue that lists him as an author.
It is possible Dr. Jackson is merely asserting that human fetal tissue research contributed
in some general way to HIV research, while his own research is responsible for saving over one
million infants. Yet if this claim refers to the United States, it is mathematically impossible. The
Centers for Disease Control and Prevention (CDC) report that women represent 20%, (246,372)
of the estimated 1,210,835 cumulative AIDS diagnoses in the United States from the beginning
of the epidemic through the end of 2014.1117 Even if every single woman in this country who
had ever been infected with HIV had also been pregnant and had further been the beneficiary of
Dr. Jacksons intervention, there are simply not enough HIV-positive women to have saved
over 1 million infant lives over the last 10 years by preventing transmission of the virus from
women to their children.
Alternatively, Dr. Jackson may be asserting that his research in other countries
(presumably the HIVNET 012 clinical trial in Africa) has alone saved 1 million infants. It is
true that global efforts to reduce HIV transmission from mothers to children have improved
outcomes for women and children worldwide. AIDS.gov reports that there are approximately 1.8
million children living with HIV worldwide. In 2015, 77% of HIV-positive pregnant women had
access to antiretroviral medicines to prevent transmission to their babies, with new HIV
infections among children declining by 50% since 2010. This is an encouraging trend, yet there
is no clear evidence that human fetal tissue was critical to either Dr. Jacksons research or to
1115

Based on the Clinical trials database: www.clinicaltrials.gov.

https://www.ncbi.nlm.nih.gov/pubmed.
1117
CDC, HIV Among Women, https://cdc.gov/hiv/group/gender/women/.
1116

391

the development of antiretroviral drug treatments for HIV. Moreover, it is disingenuous to claim
that the research of a single investigator has been responsible for the benefits provided by a
global effort to combat HIV that (in the U.S. alone) has involved:
The Department of State1118
The Department of Health and Human Services1119
The Centers for Disease Control1120
The Food and Drug Administration1121
The Health Resources and Services Administration1122
The National Institutes of Health1123
The Substance Abuse and Mental Health Service Administration1124
The Department of Commerce1125
The Department of Defense1126
The Department of Labor1127
The Peace Corps1128
The U.S. Agency for International Development1129
27,398 NIH research grants on HIV/AIDS in the last five years1130
7946 ongoing clinical trials to treat HIV/AIDS1131
5. Infant and Childhood Leukemia
The Minority Report quotes two institutions (UCLA and CHOP) who assert that fetal
tissue is important for treating childhood leukemia. Yet, as we have already noted, assertion is
not evidence, and the facts do not support this assertion. Between 2010 and 2014, the NIH
funded 887 grants on childhood leukemia, and not a single project used human fetal tissue.
Similarly, of the 750 ongoing clinical trials for childhood leukemia, not a single one involves
fetal tissue. While individual researchers and their institutions may believe without factual
support that fetal tissue is important for the study and treatment of this disease, it is not used for
any successful, NIH-funded research programs or for any clinical trials designed to cure
patients of childhood leukemia.

1118

http://www.pepfar.gov/about/agencies/c19390.htm.
http://www.pepfar.gov/about/agencies/c19401.htm.
1120
http://www.cdc.gov/globalhivtb/index.html.
1121
http://www.fda.gov/internationalprograms/pepfar/default.htm.
1122
http://hab.hrsa.gov/global-hivaids-program.
1123
https://aidsinfo.nih.gov/.
1124
http://www.samhsa.gov/hiv-aids-viral-hepatitis.
1125
http://www.pepfar.gov/about/agencies/c19398.htm.
1126
http://www.pepfar.gov/about/agencies/c19397.htm.
1127
http://www.pepfar.gov/about/agencies/c19400.htm.
1128
http://www.pepfar.gov/about/agencies/c19402.htm.
1129
https://www.usaid.gov/what-we-do/global-health/hiv-and-aids.
1130
Grants on the topic of HIV/AIDS awarded between 2011-2015 (https://projectreporter.nih.gov).
1131
www.clinicaltrials.gov.
1119

392

6. Age-related Macular degeneration (AMD)

Harvard University and the University of Michigan assert that fetal tissue is important for
the study of AMD and adult-onset disease. Go figure. While some researchers investigating
AMD use fetal eyes, the relevance of this tissue to the disease is remote, especially given the
many well-documented differences between fetal and adult neural tissue.1132
7. Preterm birth
The University of Illinois at Chicago reports that fetal tissue is essential for studying
premature birth, but (again) this claim is difficult to reconcile with the facts. In 2014, the NIH
funded 337 grants in the general area of conditions affecting embryonic and fetal periods, and
only one award employed human fetal tissue. Moreover, over a period of nine years, this project
has only been modestly productive, yielding 11 papers, only 9 of which address basic biology
and none of which appeared in top-ranked scientific journals. How this very modest level of
productivity constitutes an essential contribution to the field is hard to imagine.
8. Spinal cord injury
The Minority Report again quotes Dr. Goldsteins assertion that research trials involving
fetal tissue are vital to pushing medical science forward (p. 17), citing a single, phase I clinical
trial using fetal-derived stem cells to treat spinal cord injury. What Dr. Goldstein fails to mention
is that there are over 900 clinical trials treating spinal cord injury, including over 40 involving
stem cells derived from adult tissue and over 100 that have advanced to phase II trials. How a
single study with no published findings is pushing medical science forward in the wake of
hundreds of promising treatments for spinal injury is hard to imagine.
9. Vaccine research
The Minority Report quotes Harvard, Yale, and the University of Wisconsin in asserting
that human fetal tissue research has been vital to the development of vaccines. They falsely
assert that Panel Republicans acknowledge that the development of the polio vaccine relied on
fetal tissue research, apparently having failed to read or at least failed to understand the interim
report of the Republican members. As detailed above in Chapter 9.B.2-3, it is invalid to claim
that vaccine research would not have been possible without cells of fetal origin (p. 17). This
argument is as illogical as asserting, vaccine research would not have been possible without
automobiles, simply because automobiles were used by some vaccine researchers and may have
facilitated research in some cases. While it is impossible to know how vaccine research might
have unfolded without the use of fetal tissue, history conclusively proves that it is entirely
possible to develop vaccines without cells of fetal origin. For example, vaccines for Rabies,
Diphtheria, Typhoid, Cholera, Plague, Tetanus, Pertussis and Bacille-Calmette-Guerin disease)
1132

A survey of human brain transcriptome diversity at the single cell level. Darmanis S, Sloan SA, Zhang Y, Enge
M, Caneda C, Shuer LM, Hayden Gephart MG, Barres BA, Quake SR. Proc Natl Acad Sci U S A. 2015 Jun
9;112(23):7285-90.

393

were all developed in the 1800s and early 1900s, well before the first use of fetal tissue in
research. It is also an indisputable fact that the vaccines for Polio, Measles, Mumps and (the
first) vaccine for Rubella were all developed using animal cell culture. Finally, of the nearly 75
vaccine formulations approved for use in the United States, not a single vaccine is produced
using fetal tissue (see Exhibit 9.3).
10. Zika research
Again quoting the opinions of individuals and organizations, the Minority Report asserts
that fetal tissue is most needed in circumstances such as the Zika virus (p. 18). Yet the
published literature in this area simply does not support this assertion. As noted in Chapter 9.B.4
of this report, human fetal tissue research is not making a strong contribution to Zika research,
with the major advances published in the most respected journals involving cell culture and
animal models. Moreover, current clinical trials for a virus that causes brain defects very similar
to Zika (the Cytomegalovirus) have clearly not relied on human fetal tissue research.
11. Objective Data on the contribution of fetal tissue to basic research, clinical research, and
peer-reviewed scientific publications
It could possibly be the case that the institutions the Minority Report relied on simply
erred in identifying diseases that benefit from human fetal tissue research; i.e., if the institutions
had focused on diseases arising during fetal life and/or affecting infants and children, human
fetal tissue might play a greater role in this research. However, this is also not the case. Even for
diseases arising during fetal life, human fetal tissue research plays little or no role in basic
science investigations or clinical investigations and makes only a trivial contribution to the
scientific literature (Table 1).
Below we present data on 1) grants that the NIH lists under specific disease funding areas
that also use human fetal tissue, 2) clinical trials for specific diseases that also use human fetal
tissue (Exhibit 9.4) and 3) publications indexed in the PubMed database that include both
specific disease name and the terms fetus and humans as Medical Subject Headings (MeSH).
While the data on grants and clinical trials is comprehensive, the data on publications is
informative but likely to be less comprehensive. The PubMed database is large, indexing over 20
million research papers. It is impossible to examine publications in detail, and searches of this
database must rely on MeSH term indexing that does not specifically identify papers using
human fetal tissue for research. Consequently, some publications using fetal tissue are not likely
to be identified by this search (false negatives), and some publications that are identified do not
actually use fetal tissue for research (false positives).
For example, a large proportion of the papers indexed under the MeSH terms fetus and
preterm birth do not utilize fetal tissue for research, but rather examine aspects of fetal
physiology (heart rate, response to interventions, etc.) in an attempt to either predict or prevent
preterm delivery.1133
1133

See, e.g., Ultrasound Measurement of the Fetal Adrenal Gland as a Predictor of Spontaneous Preterm Birth.
Hoffman MK, Turan OM, Parker CB, Wapner RJ, Wing DA, Haas DM, Esplin MS, Parry S, Grobman WA, Simhan
HN, Myers S, Holder TE Jr, Rumney P, Litton CG, Silver RM, Elovitz MA, Peaceman AM, Emery S, Mercer

394

However, the relative contribution of all types of fetal research, including fetal tissue
Table 1: Contribution of human fetal tissue to disease research.
Diseases Identified in the Minority
Report
Alzheimers
Amyotrophic lateral sclerosis
Diabetes Mellitus
HIV/AIDS
Infant and Childhood Leukemia
Age-related Macular degeneration
Preterm birth*
Spinal cord injury
Vaccine research
Zika/Brain Disorders**
Diseases Arising in the Fetus
and/or Affecting Children
Attention Deficit Disorder
Autism
Batten Disease

Grants Awarded
Clinical trials
Peer Reviewed Papers
2015
Fetal Total
% Fetal Total
% "Fetus" Total
%
0 1362 0.0%
0 1956
0.0%
109
75704
0.1%
0
152 0.0%
3
360
0.8%
33
14859
0.1%
6 2382 0.3%
1 14807 0.01%
1486 353110
0.4%
74 4935 1.5%
0 7950
0.0%
372
87756
0.4%
0
339 0.0%
0
750
0.0%
21
1996
1.1%
5
187 2.7%
10 1371
0.7%
15
18826
0.1%
4
355 1.1%
0 3375
0.0%
503
9006
5.6%
0
249 0.0%
8
907
0.9%
49
41461
0.1%
28 2509 1.1%
0 7024
0.0%
509 280174
0.2%
158 52338 0.3%
0
18
0.0%
6
1926
0.3%
Grants Awarded Current clinical trials
Peer Reviewed Papers
2015
Fetal Total
% Fetal Total
% "Fetus" Total
%
0
121 0.0%
0 1277
0.0%
23
23079
0.1%
2
506 0.4%
0
741
0.0%
43
17711
0.2%
0
15 0.0%
0
23
0.0%
7
1761
0.4%

Epilepsy
2
397 0.5%
0 1404
0.0%
289 141397
0.2%
Hydrocephalus
0
15 0.0%
0
135
0.0%
275
21192
1.3%
Intellectual disabilities
10 1025 1.0%
0
541
0.0%
1255
86516
1.5%
Pediatric AIDS
0
467 0.0%
0
350
0.0%
8
1586
0.5%
Pediatric cancer
0
760 0.0%
0 1642
0.0%
302
56854
0.5%
Spinal muscular atrophy
0
34 0.0%
0
157
0.0%
15
1050
1.4%
Sudden Infant Death Syndrome
1
31 3.2%
0
89
0.0%
78
7094
1.1%
Grant data is from the NIH project reporter database. Clinical data is from the clinical trials database. Publication
data is from the PubMed database (queried for disease name, fetus and humans as MeSH terms.
* The NIH does not have a spending category for preterm birth; grant data shown is for the broader category
Conditions affecting the embryonic and fetal periods, many of which result in preterm birth or fetal demise.
**The NIH does not have a spending category for Zika research; grant data shown is for the broader category Brain
Disorders, which includes a wide range of medical conditions.

research, to various diseases can be reasonably inferred from this data, and in all cases, fetal
tissue makes a tiny contribution to disease research, if it contributes at all.

BM,Koch MA, Saade GR; Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b)
Network.. Obstet Gynecol. 2016 Apr;127(4):726-34. Intra-Amniotic Administration of HMGB1 Induces
Spontaneous Preterm Labor and Birth. Gomez-Lopez N, Romero R, Plazyo O, Panaitescu B, Furcron AE, Miller D,
Roumayah T, Flom E, Hassan SS. Am J Reprod Immunol. 2016 Jan;75(1):3-7.

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12. Conclusion
The assertions of the Minority Report are undocumented and unsupported by any of the
publicly available evidence. Rather, this evidence clearly indicates that for all of the diseases
held up as examples by the Minority Report, human fetal tissue makes little or no contribution to
either research, clinical trials or the peer-reviewed scientific literature. There is no
overwhelming evidence for the value of human fetal tissue research. In fact, there is no
evidence at all. There is only what appears to be self-interested assertion from individuals and
institutions engaged in human fetal tissue research that the Minority Report has naively accepted
as fact.
D. Analysis of currently funded long-standing human fetal-tissue research.
1. Goals of This Analysis
Many assertions have been made regarding the role of human fetal tissue in modern
biomedical research, but to date, no factual evidence in support of these assertions has been
provided. Moreover, publicly available evidence directly contradicts the claims made by
universities, scientific societies and professional medical associations that are repeated in the
Minority Report. We have presented considerable evidence that contradicts these claims.
However, the data discussed thus far does not directly address three central questions regarding
human fetal tissue research:
a. How many research projects rely on human fetal tissue?
b. How productive is human fetal tissue research, compared to non-fetal tissue research?
c. What is the impact of human fetal tissue research on the field, compared to non-fetal
research; i.e., how important is fetal research for the advance of science and medicine?
To answer these critical questions, the House Select Investigative Panel elected to conduct a
neutral and objective examination of current human fetal tissue research.
2. Criterion for Grant Selection
It is important to note that grants utilizing human fetal tissue were not evaluated by the
Panel for either the quality of the research or the competence of the investigator; i.e., it was
assumed that the process of peer review is sufficient to identify meritorious research and
successful scientists. Grants were examined only to determine the precise use of human fetal
tissue and the impact of this research on the literature. To achieve these goals, grants were
selected from the National Institutes of Health (NIH) grant database
(https://projectreporter.nih.gov), using the following criteria.
a. To determine the use of human fetal tissue over an extended period, grants funded by the
NIH over the last five years (2010-2014) were examined. A total of 329 grants using
human fetal tissue were awarded during this period. This represents approximately
0.2% of the total NIH-funded grant portfolio for these years.
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b. In order to determine the productivity and the impact of successful research programs
involving human fetal tissue, established grants (i.e., grants that had undergone
competitive renewal and had been funded for 10 or more years) were further evaluated.
c. Several grant mechanisms were excluded from detailed analysis for the following
reasons:
i.
Grants that are not directly responsible for generating scientific findings were not
analyzed (i.e., grants funding institutional core facilities or centers; P50, P30,
PN2, R24, U54 and P01 cores).
ii.
Intramural grants to NIH researchers (ZIA) were excluded because they are
awarded using criteria specific to internal NIH programs and therefore cannot be
directly compared to external research grants.
3. Grant Classification
These criteria identified a total of 36, long-standing grants to individual researchers. A
detailed inspection determined that only 34 of these projects involved primary human fetal
tissue. These 34 projects were examined by a scientific reviewer to determine the proposed use
of human fetal tissue relative to the research questions, as defined by the investigators
themselves. The 34 grants investigate a range of scientific topics, but most address either basic
mechanisms of biologic function or adult-onset disease. For example, twelve of the 34 grants
investigate conditions arising in adults, while 15 are focused on basic biological processes that
occur at all stages of life. Only a minority were focused on processes occurring during fetal life.
Based on the research questions and the use of human fetal tissue proposed by the investigators,
grants using fetal tissue were divided into three classes.
a. Class 1: Fetal tissue is required for the proposed study. There are no reasonable alternatives.
b. Class 2: Fetal tissue is not essential for the study. There are some scientific advantages to the
use of fetal tissue, but alternatives exist.
c. Class 3: Fetal tissue is not essential for the study. There are no scientific advantages to the
use of fetal tissue, and alternatives exist. In some cases, postnatal tissue is more relevant to
the scientific question.
Of the 34 long-standing grants examined, 8 (approximately 24%) require human fetal
tissue to accomplish the aims of the grant (i.e., no reasonable alternatives exist). For 5 grants
(approximately 15%), the use of human fetal tissue provides some advantage in terms of
efficiency and/or relevance to human disease. However, these advantages are not critical to
accomplish the goals of the proposed research, and reasonable alternatives exist; i.e., the
investigators themselves proposed multiple means to accomplish the same goals, most of which
did not require human fetal tissue. For the remaining 21 grants (approximately 62%), human
fetal tissue is not required to accomplish the goals of the proposed research, there are no
advantages to the use of human fetal tissue, and superior alternatives exist. The nature of the
studies and the proposed use of human fetal tissue are summarized in Exhibit 9.5, The Grant
Classification Table. NB: To avoid any privacy concerns, the names of the grants and of the
investigators that were included in the public database have been redacted.
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4. Class 1 Grant Analysis

Eight Class 1 grants were identified. This represents approximately 0.002% of the NIH
research portfolio for this period (2010-14); i.e., only 2 grants out of 100,000 are both longstanding and require human fetal tissue.
To obtain information on the relative productivity and impact of Class 1 grants, the
publicly available information was further analyzed. The NIH database of funded research
includes detailed information on publications resulting from each grant. Within the scientific
profession, one of the most widely accepted means of determining the impact of a specific
research paper is the number of citations that are made to that paper in the literature (i.e., the
citation index). Therefore, to determine the productivity and impact of human fetal tissue
research, we examined both the number of papers resulting from each grant and the number of
citations made to those papers by other researchers in the field.
Several factors must be taken into consideration when comparing research productivity
and impact across different research groups and different scientific fields. First, the number of
papers published varies considerably in different areas of research, depending on the amount of
time necessary to conduct specific kinds of scientific investigations. Moreover, laboratories at
well-endowed institutions can produce papers more rapidly, due to superior institutional support
and facilities. Therefore, simply comparing the number of publications produced by different
laboratories at different institutions can sometimes be misleading.
Similarly, the number of citations a specific paper receives can vary quite a bit from field
to field. For example, some areas of research involve a large number of investigators, and papers
in such areas receive a greater number of citations compared to papers of similar quality in
research areas with fewer investigators.
To control for these factors, the productivity and relative impact of human fetal tissue
research was determined by comparing publications that either did or did not involve human fetal
tissue that were produced by the same research groups. A detailed examination of all
publications resulting from the eight Class 1 grants identified above determined that seven of
these research groups conducted both fetal and non-fetal research (as determined by a
knowledgeable scientific reviewer), and therefore the productivity and impact of fetal and nonfetal research could be directly compared, with all other factors remaining constant.
A final factor taken into consideration was that the number of citations a paper receives is
influenced by the date of publication in both positive and negative ways. Papers published earlier
have more time to accumulate citations than recently published papers of similar quality.
Conversely, papers published long ago using outdated technology tend not to be cited in the
current literature unless they are of particular historic significanceregardless of the overall
quality and impact of the research at the time of publication. Therefore, to fairly compare fetal
and non-fetal research from the same laboratories, we considered papers published over the last
15 years (i.e., from 2001 onward), ending with the most recently published paper involving
human fetal tissue.
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5. Productivity of Human Fetal Tissue Research and Impact on the Field

The number of citations for every publication listed in the NIH database for Class 1
grants was determined.1134 From the seven Class 1 research groups that published both fetal and
non-fetal research in this period, there were 2.3x more publications not involving human fetal
tissue (Table 2). This indicates that within the same scientific discipline and the same research
laboratory, human fetal tissue research is far less productive than research not involving human
fetal tissue.
Table 2: Class 1 Grant productivity and impact.

Productivity: Average number of papers

Impact: Average number of citations/paper

Fetal
74
36

NonFetal
167
75

Similarly, publications that did not involve fetal tissue received an average of 2.1x
more citations/paper, compared to publications involving fetal tissue from the same
research group. This strongly suggests that human fetal tissue research is of lower quality
compared to studies involving fetal tissue and has significantly less impact on the field.
Human fetal tissue is currently used by a very small number of scientists, representing
less than 0.2% of the total NIH research portfolio. Detailed analysis of how human fetal tissue is
used in 34 long-standing, successful research programs has determined that fetal tissue is
actually required for only approximately 24% of these grants. For the remaining 76%, there are
reasonable alternatives to the use of human fetal tissue and, in the majority of cases, these
alternatives are superior scientific models. Based on these percentages, it is estimated that of the
current 329 NIH-funded grants using human fetal tissue, only approximately 79 (or 0.08% of the
83,592 active projects), actually require the use of human fetal tissue. Thus, despite the repeated
claim that human fetal tissue is necessary for modern biomedical research, only a tiny fraction
of NIH funded research actually requires human fetal tissue. Moreover, even in cases where use
of human fetal tissue is warranted (i.e., Class 1 grants), this analysis indicates that human fetal
tissue research is less productive and has lower impact on the field, compared to studies
from the same laboratories that do not involve human fetal tissue.
In Conclusion: This analysis strongly indicates that, in contrast to repeated assertions,
human fetal tissue research is an outdated and unproductive area of research that does not make a
Based on the citations identified using the Google Scholar search engine that is employed by the NIH:
https://scholar.google.com/.
1134

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strong impact on the field. In over 100 years of unrestricted investigation, human fetal tissue
research has had ample time to prove useful, yet it has failed to do so:
Fetal tissue HAS NOT produced a single medical treatment.
Fetal tissue WAS NOT used to cure polio, mumps, and measles.
Fetal tissue IS NOT used for modern vaccine production or research.
Fetal tissue IS NOT critical to study Zika or other diseases affecting brain development.
Fetal tissue IS NOT required for the overwhelming majority of current research.
Fetal tissue research is LESS PRODUCTIVE and has LOWER IMPACT when compared to
non-fetal tissue research.
E. Recommendations for improving access to ethical and appropriate scientific models
The House Select Investigative Panel is firmly committed to supporting scientific
research and helping it to advance as rapidly as possible towards effective and ethical treatments
for human disease. Our detailed examination of how fetal tissue is currently used in successful,
long-standing research programs (Chapter 9.D.3) revealed that in a surprising number of cases,
human fetal tissue is not the most appropriate scientific model for the proposed experiments. For
example, a number of grants focused on adult-onset neurological conditions employ human fetal
neurons as a disease model, despite the well-known differences between fetal and adult neural
cells.1135 In some cases, investigators indicate that the choice of fetal tissue is dictated by
economic reasons, including the cost and/or inconvenience of obtaining appropriate adult tissue
(see Exhibit 9.5). Whether tissue procurement companies have artificially created a market for
human fetal tissue by making diverse human fetal tissues readily available to researchers is
difficult to determine. However, there are limited commercial options for obtaining living adult
tissue and cells for research, and many companies providing this service focus on a limited
number of cell types (primarily cells from blood). The difficulty and expense of obtaining
appropriate adult tissue for research is likely to be a factor in the decision to use less
scientifically relevant human fetal tissue that is readily available through tissue procurement
companies.
Ideally, decisions about which experimental model to use for the study of a specific
medical condition should be driven by scientific criteria, not by issues of convenience or cost.
Here we make four recommendations for improving access to appropriate scientific models,
including human fetal tissue when warranted, in order to promote the advance of science and the
development of novel therapies.
1. Background for Recommendation 1: Establishing an ethically and scientifically superior
source of human fetal tissue
Stem and progenitor cells present in developing human tissues have tremendous potential
to expand scientific knowledge and treat human disease. Yet advances in both medicine and
science have been limited by the lack of a consistent and high-quality source of donated human
1135

A survey of human brain transcriptome diversity at the single cell level. Darmanis S, Sloan SA, Zhang Y, Enge
M, Caneda C, Shuer LM, Hayden Gephart MG, Barres BA, Quake SR. Proc Natl Acad Sci U S A. 2015 Jun
9;112(23):7285-90.

400

cells. The current model of obtaining human cells and tissues from legal abortion is inadequate
for three inherent reasons: 1) abortions do not represent the full range of human development and
typically do not take place during periods where the most clinically relevant cells are present; 2)
during an abortion, cells cannot be obtained in a sterile manner, and therefore these cells cannot
be used clinically or in many research applications; and 3) serious ethical objections to abortion
are likely to persist, making abortion an unreliable and inconsistent source of human cells.
In contrast, obtaining cadaveric donation of human cells and tissues from preterm and
stillborn donors avoids all three of these limitations; i.e., donations can be obtained in a
clinically useful state across the full spectrum of human development without significant ethical
controversy. The CDC estimates there are approximately 27,000 preterm deliveries and 24,000
stillbirths each year. Currently, there is only limited ability to use donated material from preterm
and stillborn infants for conventional organ transplant. Expanding the opportunities to make a
potentially life-saving donation for basic and clinical research following the tragic loss of a
desired infant would provide a tremendous comfort to many grieving parents.
Currently, human fetal tissue is used in a very small number of research programs funded
by the National Institutes of Health: approximately 0.2% of all funded research programs.
Detailed examination of a selected sample of long-standing, successful awards indicates that
only a quarter critically require human fetal tissue (Chapter 9.D.3); i.e., no reasonable
alternatives to the use of human fetal tissue exist. However, should a consistent, high-quality and
ethically uncontroversial source of human fetal tissue exist, research in this area would
undoubtedly expand enormously, advancing our understanding of human development and
leading to potentially life-saving discoveries.
In addition to basic research, many human diseases could potentially be addressed by
treatment with stem and progenitor cells. However, such regenerative-medicine approaches are
limited due to the inherent difficulty of producing cells in the laboratory that have clinically
useful properties; i.e., cells that can be transplanted into patients and that restore normal function
without forming tumors. Natural stem and progenitor cells that arise during human development
would be an ideal source of material for clinical treatment of disease, if such cells could be
obtained in a clinically appropriate and ethically uncontroversial manner.
Stakeholders in the effort to provide a consistent, high-quality and ethical source of
human fetal tissue for research and therapies include:
a. The scientific community: The scope of research would greatly expand and the pace of
discovery accelerate if a consistent source of human cells and tissues were available.
b. The medical community: Clinical application of human stem and progenitor cells would be
nearly immediate, resulting in novel treatments and cures.
c. Patients suffering from untreatable disease: The rapid advance of both basic and clinical
research would provide direct benefits to patients.
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d. Parents who have tragically lost a desired infant: Contributing to life-saving research and
medical treatments would provide great comfort to many grieving parents.
Recommendation 1: Congress will appropriate funding to the NIH for a competitive,
multi-center trial of expanding the organ-donation network to include preterm and stillborn
infant donors. Cadaveric tissues and cells would be made available to qualified scientists and
physicians for basic and clinical research. Material from elective termination of pregnancy would
be explicitly excluded from this program, both to restrict donation to clinically useful material
and to avoid ethical controversy, thereby ensuring broad, bipartisan support for this program and
providing a consistent source of high-quality donations for medicine and research.
2. Background for recommendation 2: Facilitating acquisition of adult tissue
Adult tissue (from either normal subjects or from individuals with specific medical
conditions) is the most scientifically appropriate model for the study of many adult-onset
diseases. Unfortunately, in many cases, adult tissue is not readily available for use by the
research community. Consequently, researchers focus on animal models of disease and/or
supplement this work using human fetal tissue, despite the known differences between adult and
fetal cells. If primary adult human tissue were more readily available to the research community,
it would facilitate development of appropriate research models with far greater relevance to
human disease.
Recommendation 2: The NIH will undertake a study of research demand for adult
human tissue and possible methods for facilitating the acquisition of adult cells and tissues for
research, without impacting the supply of transplantable human organs. Possible sources of
adult tissue include material from surgical procedures and cadaveric donation of tissue/organs
that are not currently used for transplantation. One potential model may be an expansion of the
National Disease Research Interchange (NDRI),1136 an NIH-supported, non-profit organ and
tissue donation network that has provided surgical and cadaveric biospecimens to researchers
for over thirty years.
3. Background for recommendation 3: Establishing guidelines for the use of human fetal tissue
The process of scientific grant review evaluates the overall quality of the proposed
research and the appropriateness of the scientific model. However, grant reviewers are not
currently asked to consider whether the use of human fetal tissue is warranted by the
experimental design, and there are no guidelines for making such a determination.
The use of animals in research provides a helpful model for the use of human fetal tissue.
The NIH has a detailed instruction on animal use (Guide for the Care and Use of Laboratory
Animals, hereinafter the Guide).1137 While supporting the value of animal research, the Guide
acknowledges, The decision to use animals in research requires critical thought, judgment, and
1136

Information about NDRI is available at http://ndriresource.org/.

National Research Council, Guide for the Care and Use of Laboratory Animals (2011),
https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf [hereinafter Guide].
1137

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analysis. Using animals in research is a privilege granted by society to the research community
with the expectation that such use will provide either significant new knowledge or lead to
improvement in human and/or animal well-being.1138 Two central principles governing the use
of animals are Replacement and Reduction, which are defined by the Guide as follows:
Replacement refers to methods that avoid using animals. The term
includes absolute replacements (i.e., replacing animals with
inanimate systems such as computer programs) as well as relative
replacements (i.e., replacing animals such as vertebrates with
animals that are lower on the phylogenetic scale).
Reduction involves strategies for obtaining comparable levels of
information from the use of fewer animals or for maximizing the
information obtained from a given number of animals (without
increasing pain or distress) so that in the long run fewer animals are
needed to acquire the same scientific information. This approach
relies on an analysis of experimental design, applications of newer
technologies, the use of appropriate statistical methods, and control
of environmentally related variability in animal housing and study
areas.1139
Similar to animal research, human fetal tissue research is controversial, with the majority
of American citizens opposing the sale of human fetal body parts for research.1140 Moreover, it is
widely acknowledged that the use of human embryos/fetuses for research purposes warrants
special consideration. For example, the 1994 NIH Report of the Human Embryo Research Panel
produced under the Clinton administration states, The Panel believes that because the
preimplantation embryo possesses qualities requiring moral respect, research involving the ex
utero preimplantation human embryo must be carefully regulated and consistently
monitored.1141 In light of the moral respect due to the human embryo/fetus, the decision to use
human fetal tissue in research is also a privilege granted by society to the research community
with the expectation that such use will provide either significant new knowledge or lead to
improvement in human . . . well-being.1142 Consequently, just as for animal research, the
decision to use human fetal tissue requires critical thought, judgment and analysis,1143 with the
1138

Id. at 4.
Id. at 5.
1140
A Rasmussen poll from 2015 indicates that 25% of likely voters support the sale of human fetal tissue, while
54% are opposed and 22% are undecided
(http://www.rasmussenreports.com/public_content/politics/current_events/abortion/voters_balk_at_sale_of_fetal_bo
dy_parts). A Fox News poll from 2015 indicates that voters are evenly split on the use of fetal tissue for research,
with 48% approving of such research, and 47% disapproving (http://www.foxnews.com/politics/2015/08/27/foxnews-poll-views-divided-over-issues-involving-abortion.html).
1141
National Institutes of Health, Report of the Human Embryo Research Panel, vol. 1. 1994. Bethesda MD,
https://repository.library.georgetown.edu/bitstream/handle/10822/559352/human_embryo_vol_1.pdf?sequence=1&i
sAllowed=y.
1142
Guide at 5.
1143
Id.
1139

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principles of Replacement and Reduction being applicable to all research programs using human
fetal tissue.
Rigorous application of these principles would serve to limit the use of human fetal tissue
to those proposals where this tissue is in fact required for the experimental question (i.e., Class 1
proposals) and would reduce the overall use of such tissue to the minimum required for obtaining
valid scientific results. Application of these principles would also serve as a vehicle for critical
thought, judgment and analysis regarding what constitutes the most appropriate scientific model
for a specific research question.
Recommendation 3: The NIH will establish guidelines for the use of human fetal tissue,
modeled on the guidelines for animal research that include the principles of Replacement and
Reduction. The NIH will mandate that these guidelines be applied to all grants proposing the
use of human fetal tissue and that funding will be contingent on the investigator
demonstrating that 1) human fetal tissue is required and appropriate for the proposed
experiments, 2) there are no reasonable alternatives or replacements for the use of human fetal
tissue, and 3) every effort has been made to reduce the amount of human fetal tissue employed
in the proposed experiments.
4. Background for recommendation 4: Assuring continued availability of funding for research
that requires human fetal tissue
The analysis of the House Select Investigative Panel indicates that, for a small number of
research programs, human fetal tissue is the most appropriate scientific model (Class 1 grants).
For a much larger number of research programs (Class 2 and Class 3), human fetal tissue is not
the most appropriate model, and alternative models are available (Chapter 9.D.3). Application of
the principles of Replacement and Reduction (See Recommendation 3, above) will serve to
distinguish proposals that require human fetal tissue (Class 1) from proposals that do not.
Appropriate classification of proposed research is required to assure continued funding for
scientifically meritorious research that requires human fetal tissue.
Recommendation 4: The NIH will adopt a three-tiered classification system for
proposals involving human fetal tissue as indicated below:
a. Class 1: Fetal tissue is required for the proposed study. There are no reasonable alternatives.
These proposals will have met all of the requirements established by the NIH guidelines
outlined in Recommendation 1 and will be fully eligible for funding, based on scientific
merit and NIH funding priorities.
b. Class 2: Fetal tissue is not essential for the study. There are some scientific advantages to the
use of fetal tissue, but alternatives exist. These proposals will have met some, but not all of
the requirements established by the NIH guidelines outlined in Recommendation 1 and will
be eligible for funding only under exceptional circumstances, as established by scientific
merit and NIH funding priorities.
c. Class 3: Fetal tissue is not essential for the study. There are no scientific advantages to the
use of fetal tissue, and alternatives exist. In some cases, postnatal tissue is more relevant to
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the scientific question. These proposals will have failed to meet the requirements established
by the NIH guidelines outlined in Recommendation 1 and will be ineligible for NIH funding.
5. Background for recommendation 5: Federal funding for fetal tissue research
Human fetal tissue is necessary for a limited number of research programs (Class 1
grants). Currently, tissue for these projects is only available from elective termination of
pregnancy. Should a program for obtaining cadaveric fetal tissue donation from preterm and
stillborn infants prove effective (Recommendation 1), this would provide a consistent source of
human fetal tissue that is both scientifically and ethically superior to tissue obtained from
induced abortion. If this is the case, fetal tissue donation should be expanded, and public research
dollars should be restricted to a source of tissue that better serves the interests of basic and
clinical research while simultaneously being ethically acceptable to all American citizens.
Recommendation 5: The NIH will report to Congress on the use of parent-donated
tissue from natural demise of preterm children, anticipated by Recommendation 1 above, and
Congress shall appropriate funds for an expansion of this program and disallow grants funded by
federal dollars to utilize human fetal tissue obtained from induced abortion.

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X. Recommendations
A. Recommendations for Direct Protection of Women and Infants
The Panel discerned a hardness and callousness toward women and infants, particularly
after a clinic entered into a contractual relationship with a fetal tissue procurement business. The
following recommendations focus on protections for women, preborn infants, and infants born
alive during abortion procedures.
1) In keeping with the principles set forth in the Belmont Report, Congress should take
appropriate measures to ensure that the informed consent provisions of 42 U.S.C. 289g1(b) & (c) protect all mothers, regardless of whether their donations of fetal tissue or the
prospective research/use of donated fetal tissue is federally funded.
2) The Panel recommends that Congress pass legislation that expands and clarifies the
definition of changing the method of abortion to ensure that abortion providers are not
modifying the care of their patients, and potentially endangering patient health, to ensure
that they can procure fetal tissue.
3) The Panel recommends that Congress take appropriate measures to ensure that the
Department of Health and Human Services conducts greater oversight over:
a. The use of fraudulent and misleading consent forms.
b. Institutional Review Boards (IRB), to avoid the mail-order version of IRBs.
c. Clinics found to have violated HIPAA.
d. The training of abortion providers and clinic employees to care for infants born
alive during abortion procedures (i.e., protocols for calling 911 and providing lifesustaining treatment pending transfer to a hospital).
4) The Panel recommends that Congress take appropriate measures to ensure that the United
State Department of Justice allocates resources for the prosecution of persons or entities
that profit from the sale of fetal tissue. Additionally, Congress should prohibit any person
from crossing state lines in order to obtain fetal tissue derived from an induced abortion
when the law of the state in which the person is doing business prohibits the donation of
such tissue.
5) Congress should pass a law providing that if the probable gestational age of the fetus is
determined to be 20 or more weeks, the physician shall make his or her best reasonable
efforts to deliver the infant alive. In such cases, no health care practitioner may use

406

digoxin or other feticide, and no physician may dismember the fetus unless it is necessary
to protect the life of the mother.1144
6) Congress should enact a law, and the Department of Health and Human Services should
promulgate detailed regulations requiring abortion providers to establish protocols for
providing emergency care to infants born alive (as defined in 1 U.S.C. 8 (b)) during
abortions or attempted abortions, pending transfer to a hospital. The regulations should
require, at a minimum, that all abortion providers are trained to preserve the life and
resuscitate any infant who is born alive, and that abortion facilities are adequately
equipped to care for infants born alive, pending transfer to a hospital. The regulations
should require the presence of a health care practitioner dedicated to caring for infants
born alive and to keeping precise records on methods of abortion, stages of gestation, and
instances where infants show signs of life.
7) Congress should establish criminal penalties and other enforcement mechanisms to hold
abortion providers accountable who fail to provide medical attention and care to infants
born alive (as defined in 1 U.S.C. 8 (b)) during an abortion or attempted abortion. At a
minimum, abortion providers must ensure that a born-alive infant receives the same
degree of care that is reasonably provided to any other child born at the same gestational
age, and ensure that the child is immediately transferred to a hospital.1145
8) Legislation should also create an office in the Department of Justice, within the Criminal
Division, to ensure the enforcement of the Partial-Birth Abortion Ban Act, Born-Alive
Infants Protection Act, and other measures recommended in this report.
9) Legislation should ensure that that the statutory definition of cadaver uniformly includes
human fetuses.
B. Recommendations for Stewardship of Taxpayer Funds
1) The Panel found that Planned Parenthood affiliates and clinics have repeatedly neglected
their fiduciary duty requiring good stewardship of federal taxpayer dollars through the
following: careless management and failed compliance with Medicaid billing procedures;
violating federal laws and regulations pertaining to patient consent and the privacy rights
of their patients; changing the method of abortion to increase procurement of fetal tissue
for which they received a per tissue payment; and a general disinterest in clinical
integrity. The Panel recommends that Planned Parenthood lose all federal funding,
including reimbursements for Medicaid services. Further, grants no longer available to
Planned Parenthood should be awarded to healthcare providers that provide
comprehensive preventive healthcare for their patients, and that do not perform abortions,
except:

1144
1145

See Pain-Capable Unborn Child Protection Act, H.R. 36, 114 th Cong. (2015).
See Born-Alive Abortion Survivors Protection Act, H.R. 3504, 114th Cong. (2015).

407

if the pregnancy is the result of an act of rape or incest;

or
in the case where a woman suffers from a physical disorder, physical
injury, or physical illness, including a life-endangering physical
condition caused by or arising from the pregnancy itself, that would,
as certified by a physician, place the woman in danger of death unless
an abortion is performed.
2) In keeping with the joint federal-state Medicaid program, the Panel recommends that
Congress pass a law explicitly permitting states to exclude abortion providers from
receiving Medicaid reimbursement (in response to narrow interpretations of current law
by President Obamas Administration and the Seventh and Ninth Circuits).1146
3) The Panel also recommends that Congress pass a law overriding the Sept. 9, 2016,
administrative rule restricting states discretion in choosing subrecipients of Title X
funding. Further, the new law should explicitly prohibit the federal government from
contracting with anyone other than a state or a states designee. That way, states will have
the flexibility to ensure that Title X funds are used in a manner compatible with state
public policy.
4) Taxpayer funding indirectly supports the practice of abortion when it funds institutions
that provide or fund abortions, or when it funds research on tissue derived from aborted
infants. Consistent with this principle, Congress should prohibit federal funding of
research involving tissue derived from induced abortions. This should be enacted to
become effective after establishment of a program that would fund alternative sources of
fetal tissue (i.e., fetal tissue from spontaneous abortions (miscarriages) or stillbirths) for
research. See subsection C, below.
C. Recommendations to Improve Biomedical Research
The House Select Investigative Panel is firmly committed to supporting scientific
research and helping it to advance as rapidly as possible towards effective and ethical treatments
for human disease. Our detailed examination of how fetal tissue is currently used in successful,
long-standing research programs (Chapter 9.D.3) revealed that in a surprising number of cases,
human fetal tissue is not the most appropriate scientific model for the proposed experiments. For
example, a number of grants focused on adult-onset neurological conditions employ human fetal
neurons as a disease model, despite the well-known differences between fetal and adult neural
cells.1147 In some cases, investigators indicate that the choice of fetal tissue is dictated by
economic reasons, including the cost and/or inconvenience of obtaining appropriate adult tissue
See Womens Public Health and Safety Act, H.R. 3495, 114th Cong. (2015).
A survey of human brain transcriptome diversity at the single cell level. Darmanis S, Sloan SA, Zhang Y, Enge
M, Caneda C, Shuer LM, Hayden Gephart MG, Barres BA, Quake SR. Proc Natl Acad Sci U S A. 2015 Jun
9;112(23):7285-90
1146
1147

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(see Exhibit 9.5). Whether tissue procurement companies have artificially created a market for
human fetal tissue by making diverse human fetal tissues readily available to researchers is
difficult to determine. However, there are limited commercial options for obtaining living adult
tissue and cells for research, and many companies providing this service focus on a limited
number of cell types (primarily cells from blood). The difficulty and expense of obtaining
appropriate adult tissue for research is likely to be a factor in the decision to use less
scientifically relevant human fetal tissue that is readily available through tissue procurement
companies.
Ideally, decisions about which experimental model to use for the study of a specific
medical condition should be driven by scientific criteria, not by issues of convenience or cost.
Here we make four recommendations for improving access to appropriate scientific models,
including human fetal tissue when warranted, in order to promote the advance of science and the
development of novel therapies.
Background for Recommendation 1: Establishing an ethically and scientifically
superior source of human fetal tissue. Stem and progenitor cells present in developing human
tissues have tremendous potential to expand scientific knowledge and treat human disease. Yet
advances in both medicine and science have been limited by the lack of a consistent and highquality source of donated human cells. The current model of obtaining human cells and tissues
from legal abortion is inadequate for three inherent reasons: 1) abortions do not represent the full
range of human development and typically do not take place during periods where the most
clinically relevant cells are present; 2) during an abortion, cells cannot be obtained in a sterile
manner, and therefore these cells cannot be used clinically or in many research applications; and
3) serious ethical objections to abortion are likely to persist, making abortion an unreliable and
inconsistent source of human cells.
In contrast, obtaining cadaveric donation of human cells and tissues from preterm and
stillborn donors avoids all three of these limitations; i.e. donations can be obtained in a
clinically useful state across the full spectrum of human development without significant ethical
controversy. The CDC estimates there are approximately 27,000 preterm deliveries and 24,000
stillbirths each year. Currently, there is only limited ability to use donated material from preterm
and stillborn infants for conventional organ transplant. Expanding the opportunities to make a
potentially life-saving donation for basic and clinical research following the tragic loss of a
desired infant would provide a tremendous comfort to many grieving parents.
Currently, human fetal tissue is used in a very small number of research programs funded
by the National Institutes of Health: approximately 0.2% of all funded research programs.
Detailed examination of a selected sample of long-standing, successful awards indicates that
only a quarter critically require human fetal tissue (Chapter 9.D.3); i.e., no reasonable
alternatives to the use of human fetal tissue exist. However, should a consistent, high-quality and
ethically uncontroversial source of human fetal tissue exist, research in this area would
undoubtedly expand enormously, advancing our understanding of human development and
leading to potentially life-saving discoveries.
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In addition to basic research, many human diseases could potentially be addressed by

treatment with stem and progenitor cells. However, such regenerative-medicine approaches are
limited due to the inherent difficulty of producing cells in the laboratory that have clinically
useful properties; i.e., cells that can be transplanted into patients and that restore normal function
without forming tumors. Natural stem and progenitor cells that arise during human development
would be an ideal source of material for clinical treatment of disease, if such cells could be
obtained in a clinically appropriate and ethically uncontroversial manner.
Stakeholders in the effort to provide a consistent, high-quality and ethical source of
human fetal tissue for research and therapies include:
1. The scientific community: The scope of research would greatly expand and the pace of
discovery accelerate if a consistent source of human cells and tissues were available.
2. The medical community: Clinical application of human stem and progenitor cells would
be nearly immediate, resulting in novel treatments and cures.
3. Patients suffering from untreatable disease: The rapid advance of both basic and clinical
research would provide direct benefits to patients.
4. Parents who have tragically lost a desired infant: Contributing to life-saving research
and medical treatments would provide great comfort to many grieving parents.
Recommendation 1: Congress will appropriate funding to the NIH for a competitive,
multi-center trial of expanding the organ-donation network to include preterm and stillborn
infant donors. Cadaveric tissues and cells would be made available to qualified scientists and
physicians for basic and clinical research. Material from elective termination of pregnancy would
be explicitly excluded from this program, both to restrict donation to clinically useful material
and to avoid ethical controversy, thereby ensuring broad, bipartisan support for this program and
providing a consistent source of high-quality donations for medicine and research.
Background for recommendation 2: Facilitating acquisition of adult tissue. Adult
tissue (from either normal subjects or from individuals with specific medical conditions) is the
most scientifically appropriate model for the study of many adult-onset diseases. Unfortunately,
in many cases, adult tissue is not readily available for use by the research community.
Consequently, researchers focus on animal models of disease and/or supplement this work using
human fetal tissue, despite the known differences between adult and fetal cells. If primary adult
human tissue were more readily available to the research community, it would facilitate
development of appropriate research models with far greater relevance to human disease.
Recommendation 2: The NIH will undertake a study of research demand for adult
human tissue and possible methods for facilitating the acquisition of adult cells and tissues for
research, without impacting the supply of transplantable human organs. Possible sources of
adult tissue include material from surgical procedures and cadaveric donation of tissue/organs
that are not currently used for transplantation. One potential model may be an expansion of the
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National Disease Research Interchange (NDRI),1148 an NIH-supported, non-profit organ and

tissue donation network that has provided surgical and cadaveric biospecimens to researchers
for over thirty years.
Background for recommendation 3: Establishing guidelines for the use of human
fetal tissue. The process of scientific grant review evaluates the overall quality of the proposed
research and the appropriateness of the scientific model. However, grant reviewers are not
currently asked to consider whether the use of human fetal tissue is warranted by the
experimental design, and there are no guidelines for making such a determination.
The use of animals in research provides a helpful model for the use of human fetal tissue.
The NIH has a detailed instruction on animal use (Guide for the Care and Use of Laboratory
Animals, hereinafter the Guide).1149 While supporting the value of animal research, the Guide
acknowledges, The decision to use animals in research requires critical thought, judgment, and
analysis. Using animals in research is a privilege granted by society to the research community
with the expectation that such use will provide either significant new knowledge or lead to
improvement in human and/or animal well-being.1150 Two central principles governing the use
of animals are Replacement and Reduction, which are defined by the Guide as follows:
Replacement refers to methods that avoid using animals. The term includes
absolute replacements (i.e., replacing animals with inanimate systems such as
computer programs) as well as relative replacements (i.e., replacing animals
such as vertebrates with animals that are lower on the phylogenetic scale).
Reduction involves strategies for obtaining comparable levels of information
from the use of fewer animals or for maximizing the information obtained from
a given number of animals (without increasing pain or distress) so that in the
long run fewer animals are needed to acquire the same scientific information.
This approach relies on an analysis of experimental design, applications of
newer technologies, the use of appropriate statistical methods, and control of
environmentally related variability in animal housing and study areas.1151
Similar to animal research, human fetal tissue research is controversial, with the majority
of American citizens opposing the sale of human fetal body parts for research.1152 Moreover, it is
widely acknowledged that the use of human embryos/fetuses for research purposes warrants
1148

Information about NDRI is available at: http://ndriresource.org/

National Research Council, Guide for the Care and Use of Laboratory Animals (2011),
https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf [hereinafter Guide].
1150
Id. at 4.
1151
Id. at 5.
1152
A Rasmussen poll from 2015 indicates that 25% of likely voters support the sale of human fetal tissue, while
54% are opposed and 22% are undecided (Available:
http://www.rasmussenreports.com/public_content/politics/current_events/abortion/voters_balk_at_sale_of_fetal_bod
y_parts). A Fox News poll from 2015 indicates that voters are evenly split on the use of fetal tissue for research,
with 48% approving of such research, and 47% disapproving (Available:
http://www.foxnews.com/politics/2015/08/27/fox-news-poll-views-divided-over-issues-involving-abortion.html).
1149

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special consideration. For example, the 1994 NIH Report of the Human Embryo Research Panel
produced under the Clinton administration states, The Panel believes that because the
preimplantation embryo possesses qualities requiring moral respect, research involving the ex
utero preimplantation human embryo must be carefully regulated and consistently
monitored.1153 In light of the moral respect due to the human embryo/fetus, the decision to use
human fetal tissue in research is also a privilege granted by society to the research community
with the expectation that such use will provide either significant new knowledge or lead to
improvement in human . . . well-being.1154 Consequently, just as for animal research, the
decision to use human fetal tissue requires critical thought, judgment and analysis,1155 with the
principles of Replacement and Reduction being applicable to all research programs using human
fetal tissue.
Rigorous application of these principles would serve to limit the use of human fetal tissue
to those proposals where this tissue is in fact required for the experimental question (i.e., Class 1
proposals) and would reduce the overall use of such tissue to the minimum required for obtaining
valid scientific results. Application of these principles would also serve as a vehicle for critical
thought, judgment and analysis regarding what constitutes the most appropriate scientific model
for a specific research question.
Recommendation 3: The NIH will establish guidelines for the use of human fetal tissue,
modeled on the guidelines for animal research that include the principles of Replacement and
Reduction. The NIH will mandate that these guidelines be applied to all grants proposing the use
of human fetal tissue and that funding will be contingent on the investigator demonstrating that
1) human fetal tissue is required and appropriate for the proposed experiments, 2) there are no
reasonable alternatives or replacements for the use of human fetal tissue, and 3) every effort has
been made to reduce the amount of human fetal tissue employed in the proposed experiments.
Background for recommendation 4: Assuring continued availability of funding for
research that requires human fetal tissue. The analysis of the House Select Investigative Panel
indicates that, for a small number of research programs, human fetal tissue is the most
appropriate scientific model (Class 1 grants). For a much larger number of research programs
(Class 2 and Class 3), human fetal tissue is not the most appropriate model, and alternative
models are available (Chapter 9.D.3). Application of the principles of Replacement and
Reduction (See Recommendation 3, above) will serve to distinguish proposals that require
human fetal tissue (Class 1) from proposals that do not. Appropriate classification of proposed
research is required to assure continued funding for scientifically meritorious research that
requires human fetal tissue.
Recommendation 4: The NIH will adopt a three-tiered classification system for
proposals involving human fetal tissue as indicated below:
1153

National Institutes of Health, Report of the Human Embryo Research Panel, vol. 1. 1994. Bethesda MD,
https://repository.library.georgetown.edu/bitstream/handle/10822/559352/human_embryo_vol_1.pdf?sequence=1&i
sAllowed=y.
1154
Guide at 5.
1155
Id.

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Class 1: Fetal tissue is required for the proposed study. There are no reasonable
alternatives. These proposals will have met all of the requirements established by the NIH
guidelines outlined in Recommendation 1 and will be fully eligible for funding, based on
scientific merit and NIH funding priorities.
Class 2: Fetal tissue is not essential for the study. There are some scientific advantages to
the use of fetal tissue, but alternatives exist. These proposals will have met some, but not
all of the requirements established by the NIH guidelines outlined in Recommendation 1
and will be eligible for funding only under exceptional circumstances, as established by
scientific merit and NIH funding priorities.
Class 3: Fetal tissue is not essential for the study. There are no scientific advantages to
the use of fetal tissue, and alternatives exist. In some cases, postnatal tissue is more
relevant to the scientific question. These proposals will have failed to meet the
requirements established by the NIH guidelines outlined in Recommendation 1 and will
be ineligible for NIH funding.
Background for recommendation 5: Federal funding for fetal tissue research.
Human fetal tissue is necessary for a limited number of research programs (Class 1 grants).
Currently, tissue for these projects is only available from elective termination of pregnancy.
Should a program for obtaining cadaveric fetal tissue donation from preterm and stillborn infants
prove effective (Recommendation 1), this would provide a consistent source of human fetal
tissue that is both scientifically and ethically superior to tissue obtained from induced abortion. If
this is the case, fetal tissue donation should be expanded, and public research dollars should be
restricted to a source of tissue that better serves the interests of basic and clinical research while
simultaneously being ethically acceptable to all American citizens.
Recommendation 5: The NIH will report to Congress on the use of parent-donated
tissue from natural demise of preterm children, anticipated by Recommendation 1 above, and
Congress shall appropriate funds for an expansion of this program and disallow grants funded by
federal dollars to utilize human fetal tissue obtained from induced abortion.

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