Abbott Lawsuit
Abbott Lawsuit
Plaintiff,
v.
Defendants,
ABBOTT LABORATORIES,
Nominal Defendant.
By and through his undersigned counsel, Plaintiff Larry Huetteman (wPlaintiffx) brings
Corporation (wAbbottx or the wCompanyx) and against certain officers and directors of the
Company for breaches of their fiduciary duties as directors and/or officers of Abbott, under the
1
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 2 of 48 PageID #:2
Illinois Business Corporation Act (wIBCAx), 805 ILCS 5 (1983), insider trading, and for
violations of Section 10b and Rule 10b-5 of the Securities Exchange Act of 1934 (wExchange
Actx) and for contribution under Sections 10(b) and 21D of the Exchange Act. As for Plaintiffys
complaint against the Individual Defendants, Plaintiff alleges the following based upon personal
knowledge as to Plaintiff and Plaintiffys own acts, and information and belief as to all other
matters, based upon, inter alia, the investigation conducted by and through Plaintiffys attorneys,
which included, among other things, a review of Defendantsy public documents, analysts
conference calls, and announcements made by Defendants, United States Securities and
Exchange Commission (wSECx) filings, wire and press releases published by and regarding
Abbott, legal filings in various regulatory proceedings against Abbott, news reports, securities
analystsy reports and advisories about the Company, information readily obtainable on the
Internet, and review and analysis of court filings in the related securities class action lawsuit
alleging violations of federal securities law based on similar facts and circumstances alleged
herein, styled Pembroke Pines Firefighters & Police Officers Pension Fund v. Abbott
Laboratories, et al., Case No. 1:22-cv-4661 (the wSecurities Class Actionx), currently pending in
the United States District Court for the Northern District of Illinois. Plaintiff believes that
substantial evidentiary support will exist for the allegations set forth herein after a reasonable
committed by Abbottys directors and officers from February 1, 2021 through June 8, 2022 (the
wRelevant Periodx).
2
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 3 of 48 PageID #:3
and health care company, selling medical devices, diagnostics, branded generic medicines and
nutritional products and generating revenues of $109 billion between 2019 and 2021.
at its facility in Sturgis, Michigan with common household names like Pedialyte, Similac, and
Ensure.
4. Abbottys primary manufacturing site for baby formula was located in Sturgis,
Michigan (wSturgisx). Prior to February 2022, Abbott had produced 40% of the United Statesy
baby formula and 40% of that amount was produced in Abbottys Sturgis plant which
manufactured infant formula feeding roughly one in six formula-fed babies in the United States.
5. This action describes Abbottys two decade long history of violations of FDA
regulations resulting in fines, consent decrees and other settlements with government agencies.
Despite repeated violations of compliance rules mandated by the Food and Drug Administration
(wFDAx), Abbottys directors failed, or refused, to implement, maintain and oversee any system of
reporting and controls that included the Sturgis facility despite repeated red flags. Abbottys latest
provider of infant formula to the nation and a material source of revenue for Abbott from
government rebates for infant formula. Inflated infant formula revenues and concealment of
material adverse non-public information inflated Companyys stock price. The Defendant
Directors ignored lapses in infant formula manufacturing safety protocols that ultimately were
linked to serious infant illnesses and even deaths and concealed those risks in publicly filed SEC
filings which were signed by the Director Defendants. When the previously concealed facts were
revealed to the investing public, the market value of Abbott common stock declined.
3
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 4 of 48 PageID #:4
6. Throughout the Relevant Period and prior thereto, the Director Defendants, a
majority of whom were directors during Abbottys prior regulatory violation proceedings and
settlements, violated their fiduciary duties to ensure that Abbott had proper reporting systems
and adequate internal controls to detect and allow the Board to monitor the type of regulatory
non-compliance by Abbott which led to the recall of its baby formula products and a protracted
7. Throughout the Relevant Period, the Individual Defendants made and/or caused
the Company to make false and misleading statements and omissions of material fact regarding
the compliance with FDA regulations regarding the safety and sanitation of Abbottys Sturgis
facility, widespread baby formula manufacturing deficiencies, the actual risk of regulatory
action, product recalls and plant shutdown presented by the conditions brought to Abbottys
8. Throughout the Relevant Period, due to the fact that the Director Defendants did
not create any operative information and control systems, Abbott management could operate
Sturgis to maximize production and profits at the expense of compliance. The Director
Defendants allowed Abbott to violate a prior agreement and consent decrees with the
Department of Justice.
complaint provided to Abbott on or about February 19, 2021 but filed earlier. The whistleblower
had made a previous attempt to alert Abbott executives of regulatory violations. By at least
September 20, 2021, Abbott received complaints of infant deaths, conditions and practices at
Sturgis that were linked to Abbottys baby formula. Also on September 20, 2021, the United
1
See https://www.supplychaindive.com/news/timeline-infant-formula-shortage/624570/ (last visited January 13,
2023)
4
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 5 of 48 PageID #:5
States Food and Drug Administration (wFDAx) began a four-day inspection of the Sturgis facility
attended by nearly a dozen investigators and issued to Abbott a w483x Report which reported the
facility wdid not maintain a building used in the manufacturing, processing, packing or holding of
infant formula in a clean and sanitary condition.x The 483 report was ignored because when
11. On February 17, 2022, the FDA publicly announced that it was investigating four
consumer complaints of infant illness related to powdered infant formula produced by Abbott in
Sturgis. The FDA stated that it had initiated an onsite inspection at the facility, and to date had
found several positive contamination results from environmental samples for a bacteria,
Cronobacter sakazakii (wCronobacterx), linked to infant illnesses and death. The FDA also
revealed that its review of Abbottys internal records indicated wenvironmental contamination
with Cronobacter and the firmys destruction of product due to the presence of Cronobacter.x
12. On the same day, Abbott issued a recall of certain baby formula products,
including the popular brands Similac, Alimentum and EleCare, all manufactured in Sturgis.
Abbott made no mention of the open FDA investigation. In the press release, Defendant
Manning, characterized Abbottys wvoluntaryx recall as wproactive,x stating: wWe know parents
depend on us to provide them with the highest quality nutrition formulas. Weyre taking this
action so parents know they can trust us to meet our high standards, as well as theirs.x
13. In the following days, Abbott was forced to close the Sturgis plant due to the
severe safety problems, shuttering one of the major sources of baby formula for the entire United
States, as well as certain Canadian and foreign markets. A nationwide shortage of baby formula
ensued. Without the Sturgis facility, the U.S. government was forced to take the unprecedented
5
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 6 of 48 PageID #:6
step of invoking the Defense Production Act to expedite production of infant formula and
authorize flights to import supply from overseas to keep the countryys most at risk population fed
and healthy.
14. After the whistleblower complaint was provided to the FDA and OSHA, the FDA
redacted copy of the FDAys report of the whistleblower complaint was publicly disclosed in
April 2022 (the wReportx). That Report contained damning conclusions implicating Abbottys
information and control systems: wEven though the acquisition [of Sturgis by Abbott] took place
many years ago, the Strugis site has never been fully integrated with Abbottys system and
internal controls.x The Report alleged that Abbottys management was aware of the issues at the
Sturgis facility well before the FDA 483 inspection. The Report stated that the whistleblower
complaint alleged that Abbott management falsified test records and released untested infant
formula to the market, and attempted to mislead the FDA during a 2019 inspection audit.
6
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 7 of 48 PageID #:7
16. In addition, the Report stated complaint alleged that the Company used testing
procedures that management knew were deficient and that Abbott was unable to adequately trace
At the Sturgis site, discipline is not applied consistently. Favored employees are
not disciplined in the same manner as those viewed as being outspoken as to
compliance issues. Enforcement is selective and inconsistent thereby signaling
retaliation to those who raise concerns.
More serious is the fact that members of management who are intimately involved
with circumventing what exist in terms of internal controls are not subject to any
discipline other than for failures to meet their metrics. These are individuals who
also repeatedly misled officials at the division and corporate level. These are
individuals who knowingly direct and approve of actions in direct violation of FDA
regulations. A culture of compliance does not exist at the Sturgis site as mandated
by the FDA and the Department of Justiceys guidance.
DeLauro, who had publicly lambasted both Abbott and the FDA for the infant formula debacle in
recent months, praised the former employee for coming forward with new details about
conditions in the plant and questionable management and in an implicit endorsement of the
2
See https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-
2021_Redacted-1-1.pdf (last visited October 25, 2022)
3
See https://www.politico.com/news/2022/08/04/baby-formula-plant-flaws-hidden-00049721
7
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 8 of 48 PageID #:8
18. Knowing that the whistleblower complaint and attendant regulatory attention and
inevitable 483 inspections could lead to the closure of the Sturgis facility, the largest baby
formula manufacturing facility in the U.S., and before disclosing it to the public, certain Abbott
insiders (referred to collectively as the Insider Trading Defendants) sold approximately $130
million worth of Abbott stock during the Relevant Period. These insiders had direct and
unfettered access to information about Sturgis violations and the incident and safety reports
concerning Sturgis, its shutdown, product recalls and federal law violations.
19. The Director Defendants violated their fiduciary duties and committed violations
of Section 10b-5 of the Securities Exchange Act of 1934 in an additional way by causing Abbott
to repurchase hundreds of millions of dollars of its own stock in the open market in the last
20. Through this action, Plaintiff seeks to recover for Abbott its damages caused by
the Individual Defendantsy various breaches of fiduciary duties and violations of the federal
securities laws pled herein as well as disgorgement of insider trading profits. The Individual
Defendants owed and owe the highest fiduciary duties to Abbott and its stockholders. They were
aware of the violations of law occurring at a manufacturing facility that was of material
importance to the Company and its business prospects, as well as to the safety of consumers who
use the Companyys products. If the Director Defendants were not aware of events and
conductions at Sturgis since 2019 it was due to their failure to implement and maintain adequate
reporting and control systems and to oversee Abbottys and indeed the Boardys own compliance
with prior government orders, decrees and settlements. Likewise, the Individual Defendants were
aware of the requirement to provide truthful, accurate, and complete information pursuant to the
8
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 9 of 48 PageID #:9
21. Under the circumstances, demand upon the current board of directors would be
futile.
22. The Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1331 and
Section 27 of the Securities Exchange Act of 1934 (the wExchange Actx) over the claims asserted
herein for, inter alia, violations of sections 10(b) of the Exchange Act and Rule 10b-5
23. This Court has supplemental jurisdiction over Plaintiffys state law claims pursuant
24. This Court has jurisdiction over each defendant named herein because each is
either a corporation that conducts business in and maintains operations in this District, is an
individual residing in this District, and/or is an individual non-resident who has sufficient
minimum contacts with this District to render the exercise of jurisdiction by the District courts
25. Venue is proper in this Court in accordance with 28 U.S.C. §1391 because: (i)
Abbott maintains its principal place of business in this District; (ii) one or more of the
Defendants either resides in or maintains offices in this District; (iii) a substantial portion of the
the wrongful acts detailed herein, occurred in this District; and (iv) Defendants have received
substantial compensation in this District by doing business here and engaging in numerous
9
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 10 of 48 PageID #:10
III. PARTIES
time of the wrongdoing alleged herein, and continuously held Abbott stock at all relevant times.
A. Nominal Defendant
board.
29. Robert B. Ford (wFordx) is Abbottys Chairman of the Board and Chief Executive
Officer. He has been a director since 2019 and assumed the role of Chairman in December 2021,
having been appointed President and Chief Executive Officer in March 2020. From 2018 to
2020, he was Abbottys President and Chief Operating Officer. He is currently a member and the
chair of the Executive Committee and was a member and the chair of the Executive Committee
30. Robert J. Alpern (wAlpernx) has been a director since 2008. He is currently a
member of the Public Policy Committee and the Nominations and Governance Committee and
was a member of the Public Policy Committee and the Nominations and Governance Committee
during the Relevant Period. He also sits on the Boards of Abbvie, Inc. and Tricida, Inc.
31. Sally E. Blount, PH.D. (wBlountx) has been a director since 2011. She is
currently a member of the Public Policy Committee and the Nominations and Governance
Committee and was a member of the Public Policy Committee and the Nominations and
Governance Committee during the Relevant Period. Ms. Blountys full-time employment appears
10
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 11 of 48 PageID #:11
to be as President and Chief Executive Officer, Catholic Charities of the Archdiocese of Chicago
32. Paola Gonzalez (wGonzalezx) has been a director since 2021. She is currently a
member of the Audit Committee and was a member of the Audit Committee during the Relevant
Period. Gonzalezys full-time job is as Vice President and Treasurer of Clorox Company.
33. Michelle A. Kumbier (wKumbierx) has been a director since 2018. She is
currently a member of the Audit and Compensation Committee and was a member of Audit and
Compensation Committee during the Relevant Period. Kumbierys full-time job is President of
Briggs & Stratton LLC. She is also a director of Tennecco, Inc. and Teledyne Technologies Inc.
34. Darren W. McDew (wMcDewx) has been a director since 2019. He is currently a
member of the Nominations and Public Policy Committee and was a member of the Nominations
and Public Policy Committee during the Relevant Period. McDew also serves on the Board of
Rolls Royce, Inc; United Services Automobile Association and Boys & Girls Club of America.
35. Nancy McKinstry (wMcKinstryx) has been a director since 2011. She is currently
a member and chair of the Audit Committee and a member of the Compensation and Executive
Committee and was a member and chair of the Audit Committee and a member of the
Compensation and Executive Committee during the Relevant Period. McKinstryys full time job
is CEO and Chairman at Walter Klumers, N.V., she is also on the Board of Accenture, plc.
36. William A. Osborn (wOsbornx) has been a director since 2008. He is currently a
member and chair of the Nominations and Governance Committee and a member of the
Compensation and Executive Committees and was a member and chair of the Nominations and
Governance Committee and a member of the Compensation and Executive Committees during
11
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 12 of 48 PageID #:12
37. Michael F. Roman (wRomanx) has been a director since 2021. He is currently a
member of the Nominations and Governance Committee and a member of the Compensation and
Executive Committees and was a member and chair of the Nominations and Governance
Committee and a member of the Compensation and Executive Committees during the Relevant
38. Daniel Starks (wStarksx) has been a director since 2017. He is currently a member
of the Public Policy Committee and was a member and of the Public Policy Committee a during
39. John G. Stratton (wStrattonx) has been a director since 2017. He is currently a
member of the Audit and Public Policy Committees and was a member of the Audit and Public
Policy Committees a during the Relevant Period. Stratton is Executive Chairman at Frontier
40. Glenn F. Tilton (wTiltonx) has been a director since 2007. He is currently a
member of the Audit, Public Policy and Executive Committees and was a member of the Audit
and Public Policy Committees a during the Relevant Period. Triton also serves on the Boards of
C. Former Directors
41. Miles D. White (wWhitex) was a director from 1998 to December 2021. He is the
former CEO, and former chair of the Executive Committee and the Executive Chairman during
42. Roxanne S. Austin (wAustinx) was a director from 2000 to April 2022.
12
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 13 of 48 PageID #:13
D. Officers
43. Defendant Robert E. Funck, Jr. (wFunckx) is Abbottys Chief Financial Officer and
Vice President, Finance. Funck assumed this role in March 2020. Prior to his appointment as
Chief Financial Officer, Funck served as Senior Vice President, Finance and Controller at
Abbott.
E. Vice Presidents
44. The Vice President Defendants all sold Abbott Labs stock during the Relevant
Nutrition. He was appointed to this role in July 2021. Prior to assuming this role, Calamari
served as Vice President, Pediatric Nutrition. Calamari joined Abbott in 2005 and has held
46. Andrea Wainer (wWainerx) is Abbottys Executive Vice President, Rapid and
47. Daniel Salvadori (wSalvadorix) is Abbottys Executive Vice President and Group
President, Established Pharmaceuticals and Nutritional Products. He was appointed to this role in
December 2021.
48. Andrew Lane (wLanex) has been Executive Vice President, Established
Diagnostics. He was appointed to this role in July 2021. Prior to assuming his current role, he
13
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 14 of 48 PageID #:14
50. Roger Bird (wBirdx) is Abbottys Senior Vice President, U.S. Nutrition. He was
51. Jared Watkin (wWatkiny) is Abbottys Senior Vice President, Diabetes Care. Prior
to assuming this role in June 2015, he served as Divisional Vice President, Technical Operations.
Cardiac Rhythm Management. He was appointed to this role in 2019. He previously served as
53. Michael Dale (wDalex) is Senior Vice President, Structural Heart Division. He
Abbottys branded medicines business. Prior to assuming this position in February 2019, he
56. Greg Ahlberg (wAhlbergx) is Senior Vice President, Core Laboratory Diagnostics,
Diagnostics. He was appointed to this role in July 2021. Prior to assuming his current role, he
58. John Capek (wCapekx) is Executive Vice President, Ventures. Dr. Capek was
appointed to this role in June 2015. In this role, he leads Abbottys venture investment
14
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 15 of 48 PageID #:15
served as Executive Vice President, Medical Devices, and Senior Vice President, Abbott
Vascular.
December 2021.
61. Defendant Hubert L. Allen (wAllenx) is and has served as Abbottys Executive
63. Abbottys Code of Business Conduct for directors states in pertinent part:
15
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 16 of 48 PageID #:16
64. Abbottys Code of Business Conduct for officers, employees, contract workers and
We create life-changing health technologies that help people live better, fuller lives.
Itys a privilege to do this work- and we need to do it in a way that lives up to the
nobility of our purpose, with the highest and most ethical of business practices.
***
The fundamental message of the Code is clear: itys up to us, as the people of Abbott,
to hold ourselves to the highest standards, to live up to our best ideals, and to operate
our business with the utmost integrity at all times. Our Code is here to help us do
so and to protect our most valuable asset as an organization - our reputation
65. With respect to Product Quality, The Code of Business Conduct states:
We endeavor to maintain the highest level of quality throughout our business. This
effort starts with the sourcing of materials and the manufacture of our products and
moves through how we market, sell, and supply our products, including through
our business partners - delivering high quality is imperative every step of the way.
Our commitment to the health and safety of the people who use our products is
always at the forefront of everything we do.
***
Q What do I do if someone tells me about a product quality issue?
66. With respect to the Companyys compliance with applicable laws and regulations,
We adhere to all laws, regulations and Abbott requirements that apply to our
work.
16
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 17 of 48 PageID #:17
Every Abbott employee is expected to adhere to all laws and Abbottys policies,
procedures, principles and standards, including this Code. This is a fundamental
expectation and condition of employment. Abbottys policies and procedures cover
topics related to important aspects of our operations, including health care
compliance, quality, engineering, customs and trade, finance, security, purchasing,
human resources, and information systems, to help ensure that we comply with the
many laws and regulations governing our business. Such policies and procedures
enable us to detect, correct and prevent non-compliant activities.
67. The Individual Defendants violated the Code of Business Conduct by failing to
proactively monitor, test, upgrade and modernize the Sturgis facility, hiding the contamination
issues at the Sturgis, and the Companyys inability to accurately identify contaminated infant
formula products for recall. The Individual Defendants also violated the Code of Business
Conduct by engaging in or permitting the scheme to issue materially false and misleading
statements to the public and/or to fail to correct false and misleading statements regarding or
concerning Abbott, and by disguising his violations of law, including breaches of fiduciary duty,
insider trading, and the aiding and abetting thereof by the Individual Defendants, and failing to
68. Abbottys has five standing committees of its Board of Directors: Audit
Committee and Public Policy Committee. Both the Audit Committee and the Public Policy
Gonzalez, Kumbier, Roman, Stratton and Tilton; Abbottys Public Policy Committee consisted of
Defendants Tilton (Ch); Alpern; Babineaux Fontenot (non-defendant); Blount; McDew; Starks
and Stratton. Defendants Tilton and Stratton sit on both committees. The Director Defendants
who were on those committees in 2021 constitute a majority of the current board.
17
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 18 of 48 PageID #:18
V. BACKGROUND
business is the discovery, development, manufacture, and sale of a broad and diversified line of
71. In its 2021 10-K, Abbott describes its operations, in part as follows:
Nutritional Products
These products include a broad line of pediatric and adult nutritional products
manufactured, marketed, and sold worldwide. These products are generally
marketed and sold directly to consumers and to institutions, wholesalers, retailers,
health care facilities, government agencies, and third-party distributors from
Abbott-owned distribution centers or third-party distributors.
various forms of infant formula and follow-on formula, including Similac®, Similac® 360 Total
Care®, Similac Pro-Advance®, Similac® Advance®, Similac® Advance® Non-GMO, Similac
Pro-Sensitive®, Similac Sensitive®, Similac Sensitive® Non-GMO, Go&Grow by Similac®,
Similac® NeoSure®, Similac® Organic, Similac® Special Care®, Similac Total Comfort®,
Similac® For Supplementation, Isomil® Advance®, Isomil®, Alimentum®, Gainu, Growu,
Similac En Mei Liu, and Elevau;
adult and other pediatric nutritional products, including Ensure®, Ensure Plus®, Ensure® Enlive®,
Ensure® (with NutriVigor®), Ensure® Max Protein, Ensure® High Protein, Glucerna®, Glucerna
Hunger Smart®, ProSureu, PediaSure®, PediaSure SideKicks®, PediaSure® Peptide, EleCare®,
Juven®, Aboundu, Pedialyte® and Zone Perfect®; and
nutritional products used in enteral feeding in health care institutions, including Jevity®,
Glucerna® 1.2 Cal, Glucerna® 1.5 Cal, Osmolite®, Oxepa®, Freegou (Enteral Pump) and
Freegou sets, Nepro®, and Vital®.
Primary marketing efforts for nutritional products are directed toward consumers
or to securing the recommendation of Abbottys brand of products by physicians or
other health care professionals. In addition, nutritional products are also promoted
directly to the public by consumer marketing efforts in markets where permitted.
Competition for nutritional products in the segment is generally from other
diversified consumer and health care manufacturers. Competitive factors include
18
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 19 of 48 PageID #:19
72. Abbott maintains 14 manufacturing facilities for its nutrition products globally.
73. Nutritional products were a major portion of Abbott revenues and earnings:
Program for Women Infants and Children (wWIC Programx) which provides rebates to
manufacturers who supply infant formula and otherwise eligible. The benefits of the program to
Abbott are conditioned upon compliance with, inter alia, provisions of the Food Drug and
Cosmetic Act (21 U.S.C. 321) applicable to the production of infant formula at the Sturgis Plant.
75. Paramount to Abbottys manufacturing is its facility in Sturgis. The Sturgis facility
singlehandedly accounted for nearly half of its infant formula where Abbott manufactures,
19
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 20 of 48 PageID #:20
processes, packs, labels, holds and distributes infant formulas that are marketed under several
76. Infant formula is a highly regulated food product that must be made in
compliance with the FDAys current good manufacturing practice (wCGMPx) requirements
established by FDA regulation. These regulations are designed to ensure the safety of infant
formula, and they require manufacturers to implement a system of controls to cover all stages of
77. The FDA has also implemented requirements for record-keeping, including a
requirement that manufacturers have procedures for handling all written and oral complaints.
78. Under these wInfant Formula Record Requirements,x manufactures must conduct
an investigation when a complaint shows a possible health hazard, and the failure to conduct
such an investigation renders infant formula produced under those conditions wadulteratedx
detailing unsafe manufacturing practices at Sturgis, and according to published reports sent a
(a) In 1999, Abbott and the FDA entered into a consent decree wto ensure
[Abbottys] diagnostic manufacturing processes in Lake County Illinois
conform with FDAys current Quality Systems Regulationx Abbott Form 8-
K date November 2, 1999. Among other directives in the decree, Abbott
agreed to pay $100,000,000. That payment constituted approximately 18 of
Abbottys net earnings that quarter (ended September 30, 1999). The consent
decree and payment was the subject of a shareholder derivative action: In
Re Abbott Laboratories, U.S.D.C. N.D. Ill. (99 C 7246). The Seventh
20
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 21 of 48 PageID #:21
(b) In 1996 Abbott entered into a consent order with the Federal Trade
Commission which had alleged in a complaint that Abbott had
misrepresented the results of a survey of doctors as to recommendations of
Abbottys Ensure, an adult nutrition supplement and the nutritional value of
Ensure. The Consent Order would automatically terminate after 20 years,
or 2016 if there were no violations of the FTC consent decree.
(c) In 2010, the Sturgis site a beetle infestation which led to recalls and shut
down of the Plant. Report at 20, n. 57.
(d)(2) A condition of the CIA and plea agreement was an annual review of the
effectiveness of Abbottys wCompliance Programx as it relates to the
marketing, promotion, and sale of pharmaceutical products by Abbottys
Board.
(d)(5) The probation terms defined wReportable Eventx as any matter that a
reasonable person would consider a probable violation of Food Drug and
Cosmetic Act FDCA 21 U.S.C. 331(a) or (c) related to the misbranding of
a pharmaceutical product within the meaning of 21 U.S.C. 352.
81. By no later than February 19, 2021, it was clear to Defendants that Abbottys
Sturgis facility was operating in an unsafe manner and in violation of numerous regulatory
requirements relative to the manufacture of infant formula and related products. It was also clear
to Defendants that these violations not only posed the threat of Abbottys rebates under the WIC
21
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 22 of 48 PageID #:22
program and regulatory enforcement and fines, but also presented grave risks to the health and
safety of the infants whose parents relied on Abbottys infant formula for their childys most
essential nutritional needs. When presented with these dire safety concerns, Defendants did
82. The Director Defendantsy failures and omission were due in part to a lack of
execution of their duties but also due to the lack of information and control systems. The FDA
report of the whistleblower investigation noted: wThe ongoing reliance on paper records is
83. Only after infant deaths connected to Abbottys baby formula were reported to the
FDA, and after the FDA finally acted on the detailed accounts of a former Abbott employee, was
Abbott forced to recall its infant formula, cease all production at the Sturgis facility, and enter
into an onerous consent decree with the United States Department of Justice and FDA.
84. The OSHA Whistleblower Report in February 2021 was corroborated by another
85. Throughout the Relevant Period, the Individual Defendants made and/or failed to
correct numerous materially false and misleading statements and/or material omissions that
concealed the wegregiously unsanitaryx conditions at the Sturgis facility, the extent to which
those issues were kept from regulators and the public, and the impact of those issues on Abbottys
business.
86. Defendants Ford, Alpern, Blunt, Austin, Gonzalez, Kumbier, McDew, Osborn,
McKinstry, Roman, Starks, Stratton and Tilton signed Abbottys materially false and misleading
Annual Report on Form 10-K for the Annual Periods ended December 31, 2020 and December
22
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 23 of 48 PageID #:23
31, 2021 (w2021 10-Kx) issued on February 18, 2022 but which failed to make any disclosure of
Abbottys problems at its Sturgis plant. Similarly, these Defendants caused Abbottys March 18,
2022 Proxy to conceal information about the problems and conditions and investigations at
Sturgis.
87. On February 19, 2021, Abbott filed its annual report for the year ended December
31, 2020, with the SEC on Form 10-K (the w2020 Annual Reportx). The 2020 Annual Report
88. In that Annual Report, Abbott stated that Total Nutritional Products sales (which
includes infant formula manufactured at Sturgis) increased 4.7% in 2020, and its U.S. Pediatric
Nutritional business sales (also including the formula produced at Sturgis) increased 5.8% in
Abbottys products are subject to rigorous regulation by the FDA and numerous
international, supranational, federal, and state authorities. The process of
obtaining regulatory approvals to market a drug, medical device, or diagnostic
product can be costly and time-consuming, and approvals might not be granted
for future products, or additional indications or uses of existing products, on a
timely basis, if at all. Delays in the receipt of, or failure to obtain, approvals for
future products, or new indications and uses, could result in delayed realization of
product revenues, reduction in revenues, and substantial additional costs.
In addition, no assurance can be given that Abbott will remain in compliance with
applicable FDA and other regulatory requirements once approval or marketing
authorization has been obtained for a product. These requirements include, among
other things, regulations regarding manufacturing practices, product labeling, and
advertising and post marketing reporting, including adverse event reports and
field alerts. Many of Abbottys facilities and procedures and those of Abbottys
suppliers are subject to ongoing regulation, including periodic inspection by the
FDA and other regulatory authorities. Abbott must incur expense and spend time
and effort to ensure compliance with these complex regulations. Possible
23
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 24 of 48 PageID #:24
89. On April 20, 2021, the Company held its first-quarter 2021 earnings conference
call. During the call, Defendant Ford stated: wIn the US and several international markets, we
continue to capture share with our leading portfolio of infant formula and toddler brands.x
90. On July 16, 2021, Abbott issued its 2020 ESG Global Sustainability Report to
shareholders. That report stated, inter alia, that wAbbottys nutrition business ensures food safety
through a tightly controlled manufacturing process that encompasses all steps from accepting
materials from suppliers through to final product distribution. We monitor and verify
microbiology, packaging integrity, and nutrient and lot control. We complete extensive finished
product testing before releasing it for commercial distribution.x Abbottys 2020 ESG Global
Sustainability Report also touted the Companyys Code of Business Conduct and strict
compliance procedures that enabled employees to wreport any concernsx because wAbbott does
not tolerate illegal or unethical behavior in any aspect of our business and that employees are
91. On July 22, 2021, the Company held its second-quarter 2021 earnings conference
call in which Defendants Ford and Funck participated. During the call, Ford stated: wIn Pediatric
Nutrition, sales grew nearly 4.5% in the quarter, led by growth of nearly 9% in the US, where we
continue to capture share with our leading portfolio of infant formula and toddler brands.
92. On October 20, 2021, the Company held its third-quarter 2021 earnings
Iyll now summarize our third quarter results ... Iyll start with Nutrition where sales
increased 9% compared to last year. Strong growth in the quarter was led by US
Pediatric and International Adult Nutrition. In Pediatric Nutrition, sales grew over
24
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 25 of 48 PageID #:25
8.5% in the quarter, led by strong growth in the US from continued share gains in
our infant formula and toddler portfolio.
93. On January 26, 2022, the Company held its fourth-quarter and year-end 2021
earnings conference call in which Defendants Ford and Funck participated. During the call,
In Pediatric Nutrition, US sales growth of more than 10% for the year was led by strong
growth of Pedialyte, our oral rehydration brand, and market share gains for Similac, our
market leading infant formula brand. During the past year, we continued to expand our
Nutrition portfolio with several new product and line extensions including the launch of
Similac 360 Total Care in the US and continued global expansion of our PediaSure,
Glucerna and Ensure brands with line extensions such as plant-based, lower sugar and high
protein products.
94. The above statements were materially false and misleading and/or omitted
information necessary to make the statements not materially false and misleading. The Individual
Defendants were aware of, but failed to disclose, the existence of manufacturing process and
contamination issues with its infant formula products which were related to infant deaths. In
addition, the violations of applicable health and safety regulations at Abbottys Sturgis facility
caused massive product recalls, exposed the Company to regulatory investigation and censure, as
95. In addition, the statements in the Companyys February 17, 2022 press release
announcing the recall of Abbottys powdered infant formula, were materially false and
misleading. That press release stated that Abbott was winitiating a proactive, voluntary recall of
powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich.,
one of the companyys manufacturing facilities.x In addition, in the press release, Manning stated:
wWe know parents depend on us to provide them with the highest quality nutrition formulas.
Weyre taking this action so parents know they can trust us to meet our high standards, as well as
theirs. We deeply regret the concern and inconvenience this situation will cause parents,
25
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 26 of 48 PageID #:26
caregivers and health care professionals.x The Company failed to disclose, however, that the
recall was made at the insistence of the FDA based on information that was known to the
contamination was found in wnonproduct contact areasx when, in fact, the FDA that the
contamination was found in areas directly contacting infant formula containers and the formula
product.
97. In May 25, 2022 testimony before the United States House of Representatives
the baby formula shortage, Defendant Calamari stated that Abbott was unaware of the
whistleblowerys complaints until late April 2022, when the complaint submitted to the FDA was
Abbott did not find out about it [the whistleblower complaint] until it was made
public in the end of April and it was the particular individual who raised the
complaint ... it was their choice to use that mechanism to raise the complaint.
98. This statement was materially false and misleading because, as disclosed two
weeks later, the whistleblower had filed a similar complaint with OSHA in February 2021.
Abbott not only received a copy of the complaint, but the Company filed a nonpublic response to
it in April 2021.
99. In the last quarter of 2021, Abbott repurchased an enormous quantity of its own
stock in the market (and publicly reporting same to investors as a sign of bullishness) pursuant to
billion of Abbott common shares. Thereafter in January 2022, Abbott purchased 650,000 shares
26
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 27 of 48 PageID #:27
of its own stock at an average price of 127.26 per share. In February 2022, Abbott repurchased
8,500,000 shares of its own stock at an average price of $123.64 per share. In March 2022,
Abbott purchased 8,113,060 shares of its own stock at an average price of $118.34 per share.
101. On February 17, 2022, the FDA publicly announced that it was investigating four
Abbott at the Sturgis facility. The FDA stated that during its an onsite inspection of the facility, it
had found Cronobacter contamination in several environmental samples that was linked to infant
illness and death. The FDA also disclosed that Abbottys internal records indicated
wenvironmental contamination with Cronobacter and the firmys destruction of product due to the
presence of Cronobacter.x
102. On the same day, Abbott issued a recall of certain infant formula products
103. On March 22, 2022, after the markets closed, the FDA released reports from three
inspections of the Sturgis facility conducted in September 2019, September 2021 and, most
recently, between January 31, 2022, and March 18, 2022. Among other things, the FDA
concluded that (a) Abbott failed to establish process controls wdesigned to ensure that infant
formula does not become adulterated due to the presence of microorganisms in the formula or in
the processing environmentx and (b) Abbott failed to wensure that all surfaces that contacted
infant formula were maintained to protect infant formula from being contaminated by any
source.x
104. On April 28, 2022, a redacted copy of a 34-page detailed whistleblower complaint
sent to the FDA in October 2021 was made public. The Complainant was a former employee of
27
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 28 of 48 PageID #:28
Abbott and his complaint was based on personal knowledge. The whistleblower complaint
revealed that Abbott was previously aware of the issues disclosed in February and March 2022.
In addition, the complaint alleged that Abbott management at the Sturgis facility had falsified
test records; released untested infant formula to the public; continued the use of testing
procedures known to be deficient; was unable to trace products in order to properly implement
product recalls; and attempted to mislead the FDA during a 2019 inspection audit.
105. Some of the most egregious violations, allegations, and findings in the Report
In countless ways, Abbott has failed to implement and actively enforce adequate
internal controls with respect to the Sturgis site. This failure does not appear to be
limited to the Sturgis site. Officials at the division level were aware of many of the
problems and failed to take corrective measures. Corporate policies and practices
were and are clearly inadequate. Indeed, there is evidence that some officials at the
division and corporate levels may also be complicit.
But from the standpoint of investors, the implications of the violations are apt to be
material in ways that may not be fully appreciated at this point in time. Certainly,
the degree to which Abbott has falsely certified its compliance with the cGMPs is
apt to heighten the materiality to shareholders.
28
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 29 of 48 PageID #:29
IV. CONCLUSION
Even though Abbottys senior management is now aware of many of the alleged
regulatory violations referenced in the foregoing, no serious effort to remedy the
violations have been reported to date. Instead, the emphasis appears to be more
focused on identifying current employees at the Sturgis site who may have reported
concerns to the Complainant. Aside from the mandate of FDA regulations, Abbottys
inaction is directly at odds with the mandate of Sarbanes-Oxley mandating adequate
internal controls and the Department of Justiceys policy mandating effective
compliance programs.
Abbottys inaction is also inconsistent with the Corporate Integrity Agreement that
it entered into with the Office of Inspector General of the Department of Health and
Human Services in May of 2012 as part of a plea agreement. United States v. Abbott
Laboratories, No. 12-cr-00026 (W.D. Va., filed May 7, 2012). At the same time,
Abbott also entered into settlement agreements with various states. Though not
directly applicable to Abbott Nutrition, the core concepts apply in terms of the
ongoing obligations on the part of Abbottys management and board of directors.
Id. at 30-31.
106. On May 16, 2022, the U.S District Court for the Western District of Michigan
107. Under the May 16, 2022 consent decree, Abbott agreed to take corrective actions
following an FDA inspection of its Sturgis. The consent decree obliges Abbott to take actions
that are expected to ultimately result in an increase of infant formula products, while ensuring
that the company undertakes certain actions that would ensure safe powdered infant formula is
produced at the facility. When the company decides to restart production at this facility, it must
conform with the provisions of the proposed consent decree and meet FDA food safety
29
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 30 of 48 PageID #:30
standards. If contamination is identified, the company must notify the FDA, identify the source
108. This consent decree also required Abbott to retain an independent expert to
review the Sturgis facilityys operations to ensure compliance with the law, requirements for
testing products, as well as ceasing production, promptly notifying the FDA should
109. On June 8, 2022, it was publicly disclosed that Abbott was aware of the
whistleblowerys formal allegations no later than early 2021, when a complaint was sent to OSHA
and then forwarded to the FDA and Abbott. Investors also learned that Abbott submitted a
110. As a direct and proximate result of the Individual Defendantsy misconduct, Abbott
has sustained millions of dollars in harm. Because of Abbottys violations at the Sturgis facility,
Abbott, and others, have been named as defendants in wrongful death actions resulting from
Similac contamination: Restad v. Abbott Laboratories, Inc., Case No. 1 :21-cv-00798-A WI-
SKO (E.D. Cal.); and from Alimentum contamination: Diebert v. Abbott Laboratories, Inc., Case
No. 1 :22-cv-01114-REB (D. Colo.) and the Securities Action. Abbott has had to close Sturgis
and to recall products manufactured there. Defendantsy actions also caused Abbott to waste
hundreds of millions of dollars on repurchasing its own stock through 2021 and the first quarter
of 2022.
111. In addition, the Company is not only paying the cost of defending itself in the
Securities Action and other actions, but it is exposed to massive potential liability for class-wide
30
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 31 of 48 PageID #:31
damages, especially in light of the recall. The Company has also incurred costs and expenses in
112. Abbott has also suffered and will continue to suffer a loss of reputation and
goodwill, and a wliarys discountx that will plague the Companyys stock in the future due to the
113. While the Companyys outside stockholders lost value, certain insiders did quite
well for themselves. In particular, defendants Lane, Capek, Salvadori, Watkin, Wainer, Starks,
Ahlberg, Woodgrift, Morrone, Bird, Karam, Pederson and Dale (the wInsider Selling
Defendantsx) sold approximately $130,000,000 worth of their stock collectively during the
Relevant Period when Abbottys stock price was at, or close to, its peak and with some sales
114. While some stock sales may have allegedly been made pursuant to various 10b5-1
plans for the respective Insider Selling Defendants, 10b5-1 plans do not provide a defense or
immunity if the plan was adopted while the seller was in possession of material non-public
information or made the sale in bad faith as is alleged here. This is especially true here because
10b5-1 plans typically allow for an insider to sell a minimal amount of pre-determined stock
during regular intervals and here these sales appear to be one-off for tens of millions of dollars
with no other sales like it in the same time frame preceding the Relevant Period.
115. Rather than providing the market with correct information, the Insider Selling
Defendants used their knowledge of Abbottys material, nonpublic information to sell their
personal holdings while the Companyys stock was artificially inflated. The insider Selling
31
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 32 of 48 PageID #:32
Defendants were privy to material, nonpublic information about the Companyys true business
health.
A. Defendant Lane
116. While in possession of this knowledge, Defendant Lane sold 145,925 shares of his
personally held Abbott stock for proceeds of $18,355,279 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
117. Lane did not purchase any Abbott stock during the Relevant Period.
118. While these shares were purportedly sold pursuant to a 10b5-1plan, the Form 4
filed for that sale does not set forth the date of that 10b5-1plan.
B. Defendant Capek
119. While in possession of this knowledge, Defendant Capek sold 149,600 shares of
his personally held Abbott stock for proceeds of $20,203,704 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
120. While these shares were purportedly sold pursuant to a 10b5-1plan, the Form 4
filed for that sale does not set forth the date of that 10b5-1plan.
32
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 33 of 48 PageID #:33
121. Capek did not purchase any Abbott stock during the Relevant Period.
122. While in possession of this knowledge, Defendant Salvadori sold 120,214 shares
of his personally held Abbott stock for proceeds of $16,471,365 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
123. While these shares were purportedly sold pursuant to a 10b5-1plan, the Form 4
filed for that sale does not set forth the date of that 10b5-1plan.
124. Salvadori did not purchase any Abbott stock during the Relevant Period.
D. Defendant Watkin
125. While in possession of this knowledge, Defendant Watkin sold 97,005 shares of
his personally held Abbott stock for proceeds of $11,507,499 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
33
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 34 of 48 PageID #:34
126. Per the Form 4 filed with the SEC in connection with the April 30, 2021 sale for
$11,339,739 worth of Abbott stock, this stock sale was not made pursuant to a previously
adopted 10b5-1plan.
127. Watkin did not purchase any Abbott stock during the Relevant Period.
E. Defendant Wainer
128. While in possession of this knowledge, Defendant Wainer sold 86,243 shares of
her personally held Abbott stock for proceeds of $11,361,423 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
129. Wainer did not purchase any Abbott stock during the Relevant Period.
F. Defendant Starks
34
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 35 of 48 PageID #:35
130. While in possession of this knowledge, Defendant Starks sold 50,000 shares of his
personally held Abbott stock for proceeds of $5,661,048 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
131. Starks did not purchase any Abbott stock during the Relevant Period.
G. Defendant Ahlberg
132. While in possession of this knowledge, Defendant Ahlberg sold 27,624 shares of
his personally held Abbott stock for proceeds of $3,568,219 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
133. Ahlberg did not purchase any Abbott stock during the Relevant Period.
H. Defendant Woodgrift
134. While in possession of this knowledge, Defendant Woodgrift sold 32,348 shares
of his personally held Abbott stock for proceeds of $3,769,819 as reflected in the chart below.
35
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 36 of 48 PageID #:36
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
135. Woodgrift did not purchase any Abbott stock during the Relevant Period.
I. Defendant Morrone
136. While in possession of this knowledge, Defendant Morrone sold 30,621 shares of
his personally held Abbott stock for proceeds of $4,098,339 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
137. Morrone did not purchase any Abbott stock during the Relevant Period.
J. Defendant Bird
138. While in possession of this knowledge, Defendant Bird sold 10,552 shares of his
personally held Abbott stock for proceeds of $1,151,558 as reflected in the chart below.
36
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 37 of 48 PageID #:37
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
139. Bird did not purchase any Abbott stock during the Relevant Period.
K. Defendant Karam
140. While in possession of this knowledge, Defendant Karam sold 28,700 shares of
his personally held Abbott stock for proceeds of $3,687,223 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
141. Karam did not purchase any Abbott stock during the Relevant Period.
L. Defendant Pederson
142. While in possession of this knowledge, Defendant Pederson sold 23,008 shares of
his personally held Abbott stock for proceeds of $2,969,173 as reflected in the chart below.
37
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 38 of 48 PageID #:38
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
143. Peterson did not purchase any Abbott stock during the Relevant Period.
M. Defendant Dale
144. While in possession of this knowledge, Defendant Karam sold 24,128 shares of
his personally held Abbott stock for proceeds of $2,888,195 as reflected in the chart below.
misstatements and omissions were exposed, demonstrate his motive in facilitating and
145. Dale did not purchase any Abbott stock during the Relevant Period.
N. Defendant Boudreau
146. While in possession of this knowledge, Defendant Boudreau sold 8,000 shares of
his personally held Abbott stock for proceeds of $1,011,920 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
38
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 39 of 48 PageID #:39
147. Boudreau did not purchase any Abbott stock during the Relevant Period.
O. Defendant Allen
148. While in possession of this knowledge, Defendant Allen sold 204,843 shares of
his personally held Abbott stock for proceeds of $25,284,600 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
149. Allen did not purchase any Abbott stock during the relevant period.
P. Defendant Scoggins
150. While in possession of this knowledge, Defendant Scoggins sold 45,000 shares of
his personally held Abbott stock for proceeds of $5,545,800 as reflected in the chart below.
His insider sales, made with knowledge of material nonpublic information, before the material
misstatements and omissions were exposed, demonstrate his motive in facilitating and
151. Scoggins did not purchase any Abbott stock during the relevant period.
39
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 40 of 48 PageID #:40
152. Plaintiff brings this action derivatively in the right and for the benefit of the
Company to redress injuries suffered and to be suffered as a direct and proximate result of the
153. Abbott is named solely as a nominal party in this action. This is not a collusive
action to confer jurisdiction on this Court that it would otherwise not have.
the Company during the period of the Individual Defendantsy wrongdoing alleged herein.
Plaintiff will adequately and fairly represent the interests of the Company in enforcing and
prosecuting its rights and retained counsel competent and experienced in derivative litigation.
155. Under the circumstances described herein, demand is excused as futile under 805
156. Seven of Abbottys 13 current directors were on Abbottys board during the five
year CIA probation period and were thus aware of the need to maintain and cultivate effective
157. In spite of Abbottys stated commitment to safety, and notwithstanding that serious
injury or death could resultvand had resultedvthe Board completely abdicated its duty to
oversee the safety of those products and the members of its community.
158. Abbott is required to comply with regulations and establish controls to monitor
and manage sanitation, health hazards and contamination. Abbott, however, did not implement or
prioritize sanitation, health hazards and contamination at the requisite level of the corporate
pyramid.
40
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 41 of 48 PageID #:41
159. The Board utterly failed to implement any reporting, internal controls, or
160. A pre-suit demand on the Board of Abbott is futile and, therefore, excused.
During the illegal and wrongful course of conduct at the Company, all of which is independently
verified and documented in the whistleblower complaint, and to the present, the Board consisted
of Defendants Ford, Alpern, Blount, Gonzalez, Kumbier, McDew, McKinstry, Osborn, Roman,
Osborn, Roman, Starks, Stratton, and Tilton were also on the board at the time of the CIA.
162. Given the factual allegations set forth herein, Plaintiff has not made a demand on
the Board to bring this action against the Individual Defendants. A pre-suit demand on the Board
would be futile as there is reason to doubt that a majority of the members of the Board are
pursue this action given the significant problem of Director Defendantsy own individual
163. The Individual Defendants either knew or should have known that of the health
and safety issues at the Sturgis facility, the danger posed by the contaminated infant formula, and
the false and misleading statements were material, paramount to the Companyys stock price and
issued on the Companyys behalf and took no steps in a good faith effort to prevent or remedy that
situation.
164. Each of the Individual Defendants approved and/or permitted the wrongs alleged
herein to have occurred and participated in efforts to conceal or disguise those wrongs from the
41
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 42 of 48 PageID #:42
Companyys stockholders or recklessly and/or with gross negligence disregarded the wrongs
COUNT I
165. Plaintiff incorporates by reference and realleges each and every allegation
166. Plaintiff asserts this Count against the Director Defendants (the wContribution
Defendantsx) who are or will be named in the future as defendants in related securities class
actions. The conduct of these Defendants, as described herein, has exposed the Company to
significant liability under various federal securities laws by their disloyal acts.
167. The Company is named as a Defendant in related securities class actions that
allege acts and conduct which constitute violations of Section 10b5 of the Securities Exchange
Act and Section 10(b) of the Exchange Act. The Company is alleged to be liable to private
persons, entities, and/or classes by virtue of many of the same facts alleged herein. These suits
have caused the Company to incur substantial costs for defense and settlement. If the Company
is found liable for violating the federal securities laws, the Companyys liability will arise in
whole or in part from the intentional, knowing, or reckless acts or omission of all or some of the
Defendants as alleged herein, who have caused the Company to suffer substantial harm through
their disloyal acts. The Company is entitled to contribution and indemnification from the
Defendants in connection with all claims that have been, are, or may be asserted against the
168. As directors, Defendants had the power to ability to, and did, control over
influence, either directly or indirectly, the Companyys general affairs, including the content of its
42
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 43 of 48 PageID #:43
public statements, and has the power or ability to directly or indirectly control or influence the
specific corporate statements and conduct that violated Section 10(b) of the Exchange Act and
169. The Defendants are liable under Section 77K(f) of the Securities Act and/or
section 21D of the Exchange Act, which provides for claims of contributions from the same
170. The Defendants have damaged the Company and are liable to the Company for
COUNT II
171. Plaintiff incorporates by reference and realleges each and every allegation
172. By virtue of their positions as officers or directors, the insider selling defendants
173. At the time the insider selling defendants initiated their sales of Abbott stock, they
knew the Sturgis facility had substantial defects, violations, and would close or was at risk of
being closed. The insider selling defendants knew these conditions, and the likelihood of having
to shutter the Sturgis facility, thereby severely undercutting potential revenue, were in direct
conflict with the bullishness expressed to the market weeks and months earlier.
174. The insider selling defendants also knew that this was information that the market
would consider material and that the announcement of the contaminated formula was virtually
certain to harm the Companyys stock price. Despite being in possession of this material
43
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 44 of 48 PageID #:44
nonpublic information, the insider selling defendants sold substantial Abbott stock during the
information, the insider selling defendants exploited their position at Abbott, and breached their
fiduciary duties to Abbott. Because the insider selling defendants sold their stock before the
non-public information in their possession could be fully disclosed to the public and harm the
Companyys stock price, the insider selling defendants improperly benefited from this breach of
fiduciary duty.
COUNT III
177. Plaintiff incorporates by reference and realleges each and every allegation
178. The Individual Defendants owed and owe Abbott fiduciary obligations. By
reason of their fiduciary relationships, the Individual Defendants owed and owe Abbott the
properly exercise their fiduciary duties. Among other things, the Individual Defendant breached
their fiduciary duties of loyalty and good faith by failing to adequately remediate the
contamination issues at the Companyys Sturgis facility; failing to maintain internal controls
adequate to enable Abbott to identify and effectively recall contaminated products; permitting
the use of inadequate practices and procedures to guide the truthful dissemination of Company
news to the investing public and to the Companyys shareholders; allowing or permitting false and
misleading statements to be disseminated in the Companyys SEC filings and other disclosures;
44
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 45 of 48 PageID #:45
and, otherwise failing to ensure that adequate internal controls were in place regarding the
serious business reporting issues and deficiencies described above. These actions could not have
been a good faith exercise of prudent business judgment to protect and promote the Companyys
corporate interests.
180. The Individual Defendants violated and breached their fiduciary duties by
engaging in the acts and omissions herein as well as by trading on material adverse non-public
information for the purpose of garnering profits and avoiding losses or failing to take action
181. As a direct and proximate result of the Individual Defendantsy breaches of their
fiduciary obligations, Abbott has sustained significant damages, as alleged herein. As a result of
the misconduct alleged herein, these defendants are liable to the Company.
COUNT IV
183. Plaintiff incorporates by reference and realleges each and every allegation
184. The Individual Defendants violated § 10(b) of the Exchange Act, 15 U.S.C. §
disseminated or approved the materially false statements specified above, which they knew or
deliberately disregarded were misleading in that they contained misrepresentations and failed to
disclose material facts necessary in order to make the statements made, in light of the
45
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 46 of 48 PageID #:46
186. The Individual Defendants violated § 10(b) of the Exchange Act and Rule 10b-5
in that they: (i) employed devices, schemes and artifices to defraud; (ii) made untrue statements
of material facts or omitted to state material facts necessary in order to make the statements
made, in light of the circumstances under which they were made, not misleading; or (iii) engaged
in acts practices and a course of business that operated as a fraud or deceit upon Plaintiff in
187. The Individual Defendants acted with scienter because they (a) knew that the
public documents and statements issued or disseminated in the name of Abbott were materially
false and misleading; (b) knew that such statements or documents would be issued or
disseminated to the investing public; and (c) knowingly and substantially participated, or
188. The Individual Defendants, by virtue of their receipt of information reflecting the
true facts of Abbott, their control over, and/or receipt and/or modification of Abbottys allegedly
materially misleading statements, and/or their associations with the Company which made them
189. As a result of the foregoing, the market price of Abbott common stock was
artificially inflated during the Relevant Period. In ignorance of the falsity of the statements,
stockholders, including Plaintiff, relied on the statements described above and/or the integrity of
the market price of Abbott common stock in purchasing Abbott common stock at prices that
were artificially inflated as a result of these false and misleading statements and were damaged
thereby.
46
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 47 of 48 PageID #:47
190. In addition, as a result of the wrongful conduct alleged herein, the Company has
suffered significant damages, including the costs and expenses incurred in defending itself in the
Securities Action and reputational harm. The Individual Defendants, through their violation of §
10(b) of the Exchange Act, 15 U.S.C. § 78j(b), and Rule l0b-5, have exposed the Company to
A. Declaring that Plaintiff may maintain this action on behalf of Abbott, and that
B. Declaring that the Individual Defendants have breached and/or aided and abetted
violations set forth above from each of the Individual Defendants, jointly and severally, together
D. Directing Abbott and the Individual Defendants to take all necessary actions to
reform and improve its corporate governance and internal procedures to comply with applicable
laws and to protect and its shareholders from a repeat of the damaging events described herein,
including, but not limited to, putting forward for shareholder vote the following resolutions for
amendments to the Companyys Bylaws or Certificate of Incorporation and the following actions
47
Case: 1:23-cv-00296 Document #: 1 Filed: 01/18/23 Page 48 of 48 PageID #:48
implement procedures for greater shareholder input into the policies and
JURY DEMAND
Lee Squitieri
SQUITIERI & FEARON, LLP
305 Broadway, 7th Floor
New York, New York 10007
(212) 421-6492
Fletcher Moore
Justin Kuehn
MOORE KUEHN, PLLC
30 Wall Street, 8th Floor
New York, New York 10005
(212) 709-8245
48
Case: 1:23-cv-00296 Document #: 1-1 Filed: 01/18/23 Page 1 of 2 PageID #:49
VERIFICATION
I, Larry Huetteman, am a plaintiff in the within action. I hereby verify that I am, and at all
relevant times relevant hereto, have been a stockholder of Abbott Laboratories. I have reviewed
the annexed Verified Shareholder Derivative Complaint, know the contents thereof, and I have
authorized counsel to file it on my behalf. To those allegations of which I do not have personal
knowledge, I rely upon my counsel and their investigation and believe them to be true.
I declare under penalty of perjury that the foregoing is true and correct. Executed on this 17
__
day of January 2023.
Larry Huetteman
Case: 1:23-cv-00296 Document #: 1-1 Filed: 01/18/23 Page 2 of 2 PageID #:50
JS 44 (Rev. 04/21) Case: 1:23-cv-00296 Document
CIVIL #: 1-2 Filed:
COVER 01/18/23 Page 1 of 2 PageID #:51
SHEET
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I. (a) PLAINTIFFS DEFENDANTS
Larry Huetteman, derivatively, on behalf of Abbott ROBERT B. FORD, ROBERT E. FUNCK, JR., JOSEPH
Laboratories Inc. MANNING, ROBERT J. ALPERN, M.D., ROXANNE S.
(b) County of Residence of First Listed Plaintiff Cook, IL AUSTIN, SALLYof E.
County of Residence BLOUNT,
First PH.D.,Lake,
Listed Defendant PAOLAIL GONZALEZ,
(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)
Edward A. Wallace, Wallace Miller, 150 N. Wacker Drive,
Suite 1100, Chicago, IL 60606. T. 312-261-6193
II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
(For Diversity Cases Only) and One Box for Defendant)
1 U.S. Government 3 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State 1 1 Incorporated or Principal Place 4 4
of Business In This State
2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated and Principal Place 5 5
Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then
the official, giving both name and title.
(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
in this section "(see attachment)".
II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box 1 or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
cases.)
III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
section for each principal party.
IV. Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
that is most applicable. Click here for: Nature of Suit Code Descriptions.
VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service.
VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket
numbers and the corresponding judge names for such cases.
Date and Attorney Signature. Date and sign the civil cover sheet.