Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 1 of 13 PageID #: 2047

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF TEXAS
BEAUMONT DIVISION

UNITED STATES OF AMERICA, )

ex. rel. BROOK JACKSON, )
)
Plaintiffs, ) Civil Action No. 1:21-cv-00008
)
v. )
)
VENTAVIA RESEARCH GROUP, LLC; )
PFIZER, INC.; ICON, PLC, )
)
Defendants. )

THE UNITED STATES’ STATEMENT OF INTEREST

SUPPORTING DISMISSAL OF THE AMENDED COMPLAINT

The United States submits this Statement of Interest pursuant to 28 U.S.C. § 517

addressing the allegations in the relator’s amended complaint (ECF No. 17). The United States

remains a real party in interest in this suit under the False Claims Act, 31 U.S.C. §§ 3729-3733,

even though it has not intervened in the case. See 31 U.S.C. § 3730(d); United States ex rel.

Eisenstein v. City of New York, 556 U.S. 928, 932-35 (2009). The False Claims Act is the

primary statute on which the Federal Government relies to combat fraud against the public fisc

and to recover taxpayer dollars lost to fraud or false claims. The Government therefore has a

substantial interest in the development of the law in this area and in the correct application of

that law in this and similar cases. While fraud on the Food and Drug Administration or the

failure to comply with clinical trial protocols could potentially give rise to False Claims Act

liability in an appropriate case, in the instant case the complaint does not plead a sufficient nexus

between the alleged clinical trial violations and the alleged requests for payment from the

Government to support such liability.

1
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 2 of 13 PageID #: 2048

BACKGROUND

On January 8, 2021, the relator Brook Jackson filed a qui tam action under seal against

Pfizer, Inc., which developed the Pfizer-BioNTech COVID-19 vaccine with BioNTech SE; Icon

PLC, an Irish research organization that allegedly oversaw over 160 Pfizer-BioNTech COVID-

19 vaccine clinical study sites; and her former employer, Ventavia Research Group, LLC, which

allegedly contracted with Pfizer to operate three (3) Pfizer-BioNTech COVID-19 vaccine study

sites. 1 Ms. Jackson, who allegedly worked as a regional director at Ventavia for less than three

weeks from September 8-25, 2020, alleged violations of the False Claims Act in connection with

the Pfizer-BioNTech COVID-19 vaccine clinical study.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has

caused over 95 million COVID-19 cases and claimed the lives of over 1 million people in the

United States alone.2 In January 2020, the Secretary of the Department of Health and Human

Services (HHS) issued a declaration of a public health emergency related to COVID-19, 3 and on

February 4, 2020, 4 and March 27, 2020,5 declared that circumstances exist justifying the

1
See Compl. (ECF No. 2) paras. 3-5; Am. Compl. (ECF No. 17) paras. 3-5.
2
U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#datatracker-home
3
U.S. Department of Health and Human Services, Office of the Assistant Secretary for
Preparedness and Response, Declaration of Public Health Emergency, Jan. 31, 2020,
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
4 U.S. Department of Health and Human Services, Notice of Determination of Public
Health Emergency, Feb. 4, 2020, https://www.federalregister.gov/documents/2020/02/07/2020-
02496/determination-of-public-health-emergency
5
U.S. Department of Health and Human Services, Emergency Use Authorization
Declaration, Mar. 27, 2020, https://www.federalregister.gov/documents/2020/04/01/2020-
06905/emergency-use-authorization-declaration
2
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 3 of 13 PageID #: 2049

authorization of emergency use of drugs and biological products during the COVID-19

pandemic. 6

Pfizer, in partnership with BioNTech, developed a COVID-19 vaccine using mRNA

vaccine technology. 7 In July 2020, the U.S. Army Contracting Command selected Pfizer as the

awardee of a Project Agreement under which Pfizer would deliver 100 million doses of an FDA

authorized or approved vaccine to the Government on a firm fixed price per dose basis, in

accordance with a Statement of Work (SOW). 8 The introductory section of the SOW for the

Project Agreement explains that the “intent” of the project is “to demonstrate that Pfizer has the

business and logistics capability to manufacture 100M doses of its currently unapproved mRNA-

based COVID-19 vaccine for the Government.”9 For “background and context,” the SOW

explains that “Pfizer will meet the necessary FDA requirements for conducting ongoing and

planned clinical trials, and with its collaboration partner, BioNTech, will seek FDA approval or

authorization for the vaccine, assuming the clinical data supports such application for approval or

authorization.” 10 The SOW expressly recognizes that the vaccine “clinical trials are regulated by

the FDA and HHS,” and specifies that “there is no need for separate regulation by the U.S. Army

Medical Research and Materiel Command.” 11

While clinical activities are described in the background section, the scope section of the

SOW states that clinical activities not related to the manufacturing of the vaccine are “out-of-

6
See 21 U.S.C. § 360bbb-3 (authorizing FDA to issue an emergency use authorization
under certain circumstances during a public health emergency for an unapproved medical
product, such as a vaccine, to be used to prevent, diagnose, or treat serious or life-threatening
diseases or conditions).
7
Am. Compl. paras. 71, 73.
8
Am. Compl. Ex. 10.
9
Id. at JSN0296.
10
Id. at JSN0297.
11
Id.
3
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 4 of 13 PageID #: 2050

scope” for the project as Pfizer and BioNTech have funded, and will continue to fund, those

clinical activities “without the use of Government funding.”12 “Provided the FDA has granted

approval or authorization,” the payment section of the SOW states, “100M doses will be

provided by Pfizer to the Government on a Firm Fixed Price per dose basis in accordance with

the Milestone Payment Schedule.” 13 “For clarity,” the payment section of the SOW adds that

“the Government will have no right to withhold payment in respect of any delivered doses,

unless the FDA has withdrawn approval or authorization of the vaccine.” 14

In October 2020, FDA issued guidance regarding the data and information needed to

support issuance of an Emergency Use Authorization (EUA) for COVID-19 vaccines. 15 The

guidance explained that FDA may issue an EUA after FDA has determined that the following

key criteria are met:

• Based on the totality of scientific evidence available, including data from adequate
and well-controlled trials, if available, it is reasonable to believe that the vaccine may
be effective to prevent, diagnose, or treat such serious or life-threatening disease or
condition that can be caused by SARS-CoV-2.

• The known and potential benefits of the vaccine, when used to diagnose, prevent, or
treat the disease or condition that can be caused by SARS-CoV-2, outweigh the
known and potential risks of the vaccine.

On November 20, 2020, Pfizer submitted an EUA request to FDA for the Pfizer-

BioNTech COVID-19 vaccine. The request included safety and efficacy data from the Pfizer-

BioNTech COVID-19 vaccine clinical trial, in which approximately 44,000 participants were

12
Id. at JSN0302.
13
Id. at JSN0309.
14
Id. at JSN0310.
15
See FDA Guidance for Industry, Emergency Use Authorization for Vaccines to Prevent
COVID-19, Oct. 6, 2020, https://www.regulations.gov/document/FDA-2020-D-1137-0019
4
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 5 of 13 PageID #: 2051

enrolled.16 Data analysis from 36,621 trial participants demonstrated the vaccine’s efficacy was

95 percent in preventing confirmed COVID-19 occurring at least seven days after the second

dose. 17 Safety data from approximately 38,000 participants suggested a favorable safety profile

and raised no specific safety concerns that would preclude issuance of an EUA. 18 Accordingly,

FDA concluded that the key criteria for issuance of an EUA were met—based on the totality of

the scientific evidence available, it was reasonable to believe the Pfizer-BioNTech COVID-19

vaccine may be effective to prevent the condition or disease caused by SARS-CoV-2, and the

known and potential benefits of the vaccine outweighed the potential risks. FDA therefore

issued the EUA on December 11, 2020. 19

About eight months later, on August 23, 2021, FDA announced its approval of the Pfizer-

BioNTech COVID-19 vaccine, marketed as Comirnaty. 20 FDA explained that the vaccine’s

approval was based on an “incredibly thorough and thoughtful evaluation of this vaccine,” which

included review of “updated data from the clinical trial which supported the EUA and included a

longer duration of follow-up in a larger clinical trial population.”21 In November 2021, nearly a

year after FDA granted the EUA for the Pfizer-BioNTech COVID-19 vaccine, FDA affirmed to

16
FDA Review Memorandum, EUA for Pfizer-BioNTech COVID-19 Vaccine/BNT162b2,
Dec. 11, 2020, https://www.fda.gov/media/144416/download
17
Id. at p. 6.
18
Id. at p. 6.
19
FDA News Release, FDA Takes Key Action in Fight Against COVID-19 By Issuing
Emergency Use Authorization for First COVID-19 Vaccine, Dec. 11, 2020,
https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-
covid-19-issuing-emergency-use-authorization-first-covid-19
20
FDA News Release, FDA Approves First COVID-19 Vaccine, Aug. 23, 2011,
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-
vaccine#:~:text=Today%2C%20the%20U.S.%20Food%20and,years%20of%20age%20and%20o
lder.
21
Id. (“More than half of the clinical trial participants were followed for safety outcomes
for at least four months after the second dose. Overall, approximately 12,000 recipients have
been followed for at least 6 months.”).
5
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 6 of 13 PageID #: 2052

the British Medical Journal that it had “full confidence in the data that were used to support the

Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.” 22

On January 18, 2022, the United States declined to intervene in this qui tam action (ECF

No. 13). The Court unsealed the case on February 10, 2022 (ECF No. 16). On February 22,

2022, the relator filed an amended complaint that is substantially similar to the original

complaint (ECF No. 17). Defendants Pfizer, Icon, and Ventavia moved to dismiss (ECF Nos.

37, 50-51, 53). The relator filed an opposition to the motions to dismiss on August 22, 2022

(ECF No. 65). Defendants filed replies on September 20, 2022 (ECF Nos. 67-69).

DISCUSSION

The False Claims Act (FCA) permits either the Attorney General or a private party to

initiate a civil action alleging fraud on the Government. See 31 U.S.C. §§ 3730(a), (b). A

private enforcement action under the FCA is called a qui tam action, with the private party

referred to as the “relator.” See Vermont Agency of Nat. Res. v. United States ex rel. Stevens, 529

U.S. 765, 769 (2000). The FCA creates liability for one who “knowingly presents, or causes to

be presented, a false or fraudulent claim for payment or approval,” 31 U.S.C. § 3729(a)(1)(A), as

well as one who “knowingly makes, uses, or causes to be made or used, a false record or

statement material to a false or fraudulent claim,” id. § 3729(a)(1)(B).

Congress intended the FCA “to reach all fraudulent attempts to cause the Government to

pay out sums of money or to deliver property or services.” S. REP. 99-345, 9, 1986

U.S.C.C.A.N. 5266, 5274; see also Cook County, Ill. v. United States ex rel. Chandler, 538 U.S.

119, 129 (2003) (“Congress wrote [the False Claims Act] expansively, meaning to ‘reach all

22
Rebecca Coombes, Rapid Response Re: COVID-19 Researcher blows the whistle on data
integrity issues in Pfizer’s vaccine trial, Nov. 15, 2021,
https://www.bmj.com/content/375/bmj.n2635/rr-41
6
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 7 of 13 PageID #: 2053

types of fraud, without qualification, that might result in financial loss to the Government.’”

(quoting United States v. Neifert-White Co., 390 U.S. 228, 232 (1968))). Consistent with this

broad construction of the FCA, courts have recognized multiple ways in which a defendant may

violate the FCA, including by making an express or implied false certification, or engaging in

fraud in the inducement.

Express false certification liability may attach when a defendant falsely and expressly

certifies compliance with a condition of payment in connection with a claim for Government

reimbursement. See, e.g., United States ex rel. Thompson v. Columbia/HCA Healthcare Corp.,

125 F.3d 899, 902 (5th Cir. 1997). The Supreme Court has recognized that the implied false

certification theory may apply “at least” where “the claim does not merely request payment, but

also makes specific representations about the goods or services provided” and the defendant’s

failure to disclose noncompliance with a material requirement renders those representations

“misleading half-truths.” Universal Health Servs., Inc. v. United States ex rel. Escobar, 579 U.S.

176, 190 (2016). Other courts have recognized that the implied false certification theory may

also be viable when the submission of the claim implicitly represents that the claimant is legally

entitled to payment and the claimant’s failure to disclose noncompliance with a material payment

requirement renders the claim misleading. See United States ex rel. McBride v. Halliburton Co.,

848 F.3d 1027, 1031 n.4 (D.C. Cir. 2017) (“The Supreme Court left open the question of whether

a claim that ‘merely demand[s] payment,’ as opposed to one that makes specific representations

about the goods or services provided, can count as the requisite misleading representation.”); see

also United States ex rel. Campbell v. KIC Dev., LLC, No. EP-18-CV-193-KC, 2019 WL

6884485, at *7 (W.D. Tex. Dec. 10, 2019) (“The Court has not found any Fifth Circuit case law

7
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 8 of 13 PageID #: 2054

that elaborates on Escobar’s ‘specific representations’ requirement—to the extent that it is an

absolute requirement.”).

The “fraud in the inducement” theory helps explain why a claim can be “false or

fraudulent” even in situations where the underlying claim for payment is not false on its face, nor

makes any false certification. See United States ex rel. Laird v. Lockheed Martin Eng’g & Sci.

Servs. Co., 491 F.3d 254, 259 (5th Cir. 2007) (recognizing the fraud in the inducement theory

under the FCA in a bid-rigging case). Consistent with this theory, it may be possible to articulate

a viable FCA claim based on materially false or fraudulent statements made to FDA related to a

drug or vaccine authorization or approval. For example, if a manufacturer makes false

statements to FDA about its product, and those false statements actually cause FDA to authorize

or approve the product (i.e., where FDA would not have taken those actions had it known the

truth), then FCA liability could potentially attach. That is, liability is possible if the defendant’s

fraud actually induced FDA to authorize or approve a product, thereby improperly rendering it

eligible for subsequent payment by the Government. See United States ex rel. Campie v. Gilead

Scis., Inc., 862 F.3d 890, 902-04 (9th Cir. 2017) (holding defendant’s alleged misrepresentations

to FDA rendered each subsequent claim for payment for the drug false or fraudulent under a

fraud in the inducement or promissory fraud theory); United States ex rel. Brown v. Pfizer, Inc.,

No. CV 05-6795, 2017 WL 1344365, at *9-10 (E.D. Pa. Apr. 12, 2017) (holding complaint

stated a claim under fraud in the inducement theory where factual allegations demonstrated how

defendant’s alleged misrepresentations to FDA regarding clinical study results caused FDA to

approve the drug).23

23
While the United States disagrees with Pfizer’s arguments regarding the validity of a
fraud in the inducement theory based on false or fraudulent statements to FDA, see ECF No. 67

8
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 9 of 13 PageID #: 2055

Under Federal Rule of Civil Procedure 8(a)(2), a complaint must contain a “short and

plain statement of the claim showing that the pleader is entitled to relief.” As the Supreme Court

held in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), a complaint survives a motion to

dismiss if it contains enough facts, accepted as true, “to state a claim to relief that is plausible on

its face.” Id. at 570. Facial plausibility requires that the plaintiff “plead[ ] factual content that

allows the court to draw the reasonable inference that the defendant is liable for the misconduct

alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). “Where the well-pleaded facts of a

complaint do not permit a court to infer more than the mere possibility of misconduct, the

complaint has alleged—but it has not ‘show[n]’—‘that the pleader is entitled to relief.’” Walker

v. Beaumont Indep. Sch. Dist., 938 F.3d 724, 734 (5th Cir. 2019) (quoting Iqbal, 556 U.S. at

678); see Cuvillier v. Taylor, 503 F.3d 397, 401 n.4 (5th Cir. 2007) (noting, in the past, the court

frequently used the expression that a case will not be dismissed “unless it appears beyond doubt

that the plaintiff can prove no set of facts in support of his claim which would entitle him to

relief,” however, the Supreme Court retired the “no set of facts” language in Bell Atlantic Corp.

v. Twombly, 550 U.S. 544 (2007)).

In this case, the relator’s complaint alleges that Pfizer’s claims for payment from the

Government were “false and/or fraudulent by express and implied false certifications” of

compliance with the clinical trial protocol and regulations. 24 However, the complaint fails to

allege facts sufficient to support an express or implied false certification theory. The complaint

does not plead facts indicating how any express or implied representations in connection with

at pp. 3-5, the Court need not determine the validity of the fraud in the inducement theory to
resolve the motions to dismiss as the complaint lacks factual allegations that would support the
theory, assuming its validity.
24
See Am. Compl. paras. 274-75.
9
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 10 of 13 PageID #: 2056

Pfizer’s claims for payment were false or misleading in light of Ventavia’s alleged clinical trial

violations. 25 The complaint does not identify any provision in the SOW for the Project

Agreement between Pfizer and the Army that conditioned Government payment for the vaccine

on Pfizer’s compliance with the clinical trial protocol or regulations.26 The SOW, which is

attached to the complaint, further specifies that the Army did not regulate the conduct of the

clinical trial, which is “out-of-scope” for the purchase agreement between the Army and Pfizer. 27

In short, the complaint does not plead factual content to support a conclusion that compliance

with the clinical trial protocol or regulations was necessary under the contract between Pfizer and

the Army such that clinical trial violations would give rise to a claim for express or implied

certification liability.

As the complaint notes, the contract did condition payment between Pfizer and the Army

on FDA approval or authorization of the vaccine. This provision in the contract could support a

claim for fraud in the inducement if the complaint had pleaded facts supporting an inference that

the alleged clinical trial violations at the Ventavia sites actually altered FDA’s approval or

authorization decision. However, while the complaint generally contends that the alleged

clinical trial violations by Ventavia “call[] the vaccine’s EUA into question,” there are no

allegations in the complaint that the data from the Ventavia sites caused FDA to authorize the

vaccine or that FDA would have revoked authorization had it known about the alleged clinical

25
See id. para. 138 (“Under the contract, Pfizer sends monthly invoices to DoD at $19.50
per dose for each delivery of vaccines, which are paid within thirty days”), para. 278
(“Defendant Pfizer certified in its claims for payment that they were true and correct, prepared
from Pfizer’s books and records, and in accordance with the Pfizer-DoD contract.”).
26
See id. para. 135 (“DoD contracted to pay Pfizer $1.95 billion for the vaccines ($19.50
per dose) after FDA approval or Emergency Use Authorization (‘EUA’).”).
27
Id. Ex. 10 at JSN0297, 0302.
10
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 11 of 13 PageID #: 2057

trial violations by Ventavia. 28 Also absent from the complaint are factual allegations indicating

that the alleged violations at the Ventavia sites resulted in FDA receiving fabricated, inaccurate,

or misleading data about the safety or efficacy of the vaccine. The complaint does not, for

example, identify any safety risk that was hidden from FDA in the data from the Ventavia sites,

or any symptomatic participants who Ventavia did not properly test for COVID-19 infection, or

any COVID-19 infections in vaccinated participants that Ventavia falsely reported to have

occurred in the placebo group. 29 In other words, the complaint does not plead facts that would

allow the Court to reasonably infer that the alleged protocol deviations at the Ventavia sites

would have affected the safety or efficacy data generated at those sites. 30 Moreover, even if the

allegations were sufficient to show that Ventavia’s safety and efficacy data was unreliable, a

conclusion that the criteria for issuance of an EUA would not have been met without the

Ventavia data is implausible considering that authorization is based on “the totality of scientific

28
See id. para. 287.
29
See, e.g., id. para. 153 (alleging that Ventavia did not test Subject 11281302 for COVID-
19 until after the vaccine was administered without alleging that Subject 11281302 was COVID-
19 positive and should have been excluded from the study), paras. 183-186 (alleging Ventavia
failed to report adverse events to Pfizer and Icon without describing or identifying any particular
adverse event that was not properly reported), Ex. 12 (reporting that an adverse event report had
been completed and faxed to Pfizer for Subject 10961031 on account of a positive pregnancy test
prior to vaccination), Ex. 17 (indicating the protocol for reporting adverse events was unclear
and recommending that QC look for potential adverse events not caught during study visits and
flag them for correction).
30
See, e.g., id. para. 165 (alleging that Ventavia likely mispresented the time that
participants’ vital signs were taken to conceal the fact that vitals were taken before or during the
informed consent process without alleging that informed consent was never obtained or
providing any factual basis to conclude that the timing of informed consent could impact the
study’s evaluation of the vaccine’s safety or efficacy), para. 190 (alleging deviations in blood
sample clotting, centrifuge, and freezing times without pleading facts indicating whether or how
those alleged deviations could affect the evaluation of the blood samples or the measure of safety
or efficacy of the vaccine), para. 194 (alleging that a Ventavia employee changed a participant’s
blood pressure reading without explaining how the reading was changed or what impact, if any,
the change could have on the safety or efficacy results).
11
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 12 of 13 PageID #: 2058

evidence available” 31 and the complaint alleges that Ventavia enrolled only about 3 percent, or

approximately 1,500 of the nearly 44,000 total clinical trial participants. 32

In sum, the relator’s complaint lacks factual allegations that would support a plausible

claim that Ventavia’s clinical trial violations masked problems with the vaccine that were so

serious that FDA would have withheld or withdrawn its authorization of the vaccine had it

known the truth, such that Pfizer’s subsequent claims for Government payment for the vaccine

could be rendered “false or fraudulent” under the FCA. 33

CONCLUSION

For the reasons stated above, the United States supports dismissal of the relator’s

complaint.

31
See FDA Guidance for Industry, Emergency Use Authorization for Vaccines to Prevent
COVID-19, Oct. 6, 2020, https://www.regulations.gov/document/FDA-2020-D-1137-0019
(explaining that FDA may issue an EUA when, based on “the totality of scientific evidence
available,” it is “reasonable to believe” the vaccine “may be effective” and the “known and
potential benefits” of the vaccine “outweigh the known and potential risks”); see also FDA
Review Memorandum, EUA for Pfizer-BioNTech COVID-19 Vaccine/BNT162b2, Dec. 11,
2020, at pp. 6-8 (recommending issuance of an EUA based on “the totality of scientific evidence
available,” which includes data from over 36,000 clinical trial participants, which showed the
vaccine to be 95 percent effective and raised no safety concerns that would preclude issuance of
an EUA).
32
See Am. Compl. para. 4 (alleging that Icon oversaw over 160 clinical trial sites
worldwide), para. 5 (alleging that Pfizer contracted with Ventavia to provide three (3) test sites),
para. 80 (“A total of 43,998 participants were enrolled in Phase 3 of the trial at issue, per Pfizer’s
reporting on clinicaltrials.gov. Approximately 1,500 of those were enrolled at Defendant
Ventavia’s facilities.”).
33
The Court need not consider whether the relator’s claims are subject to dismissal for
noncompliance with a dispute resolution provision in the vaccine purchase agreement between
Pfizer and the Army. See ECF No. 37 at pp. 27-30. The United States does not concede that the
dispute resolution provision would apply to an FCA claim brought by the United States premised
on clinical trial fraud on FDA. See Am. Compl. Ex. 10 at JSN0302 (specifying that the conduct
of the clinical trial is outside the scope of the purchase agreement). In any event, it is
unnecessary for the Court to address the dispute resolution provision as the pending motions may
be resolved on other grounds.
12
Case 1:21-cv-00008-MJT Document 70 Filed 10/04/22 Page 13 of 13 PageID #: 2059

Respectfully submitted,

BRIAN M. BOYNTON
Acting Assistant Attorney General

BRIT FEATHERSTON
United States Attorney
Eastern District of Texas

/s/ Michael W. Lockhart

MICHAEL W. LOCKHART
Assistant United States Attorney
Texas Bar No. 12472200
550 Fannin, Suite 1250
Beaumont, TX 77701
Tel: (409) 839-2538
Fax: (409) 839-2643
Email: [email protected]

ANDY J. MAO
HOLLY H. SNOW
Attorneys, Civil Division
United States Department of Justice
175 N Street, N.E.
Washington, DC 20002
E-mail: [email protected]
(202) 616-2879
(202) 305-7797 (fax)

ATTORNEYS FOR THE

UNITED STATES OF AMERICA

CERTIFICATE OF SERVICE

I hereby certify on this 4th day of October 2022, I caused copies of the foregoing
document to be served on all counsel of record through the Court’s electronic filing system.

/s/ Michael W. Lockhart

MICHAEL W. LOCKHART

13