United States’ Motion to Intervene and to Dismiss Pursuant to 31 U.S.C. § 3730(c)(2)(A), Case 1:21-cv-00008-MJT, Document 137
Summary
The United States' motion, filed 03/12/24 in the Eastern District of Texas, to intervene in and dismiss Brook Jackson's False Claims Act suit against Ventavia Research Group, LLC, Pfizer, Inc. and Icon PLC, case 1:21-cv-00008-MJT. The government relies on United States ex rel. Polansky v. Executive Health Resources, Inc., decided in 2023, which lets it dismiss a qui tam case over the relator's objection after showing good cause to intervene. The motion recounts that Jackson filed on January 8, 2021, alleging protocol violations at three Pfizer-BioNTech COVID-19 vaccine trial sites in Texas and misrepresentations to FDA, that the United States declined to intervene on January 18, 2022, and that she amended her complaint on February 22, 2022.
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Case 1:21-cv-00008-MJT Document 137 Filed 03/12/24 Page 1 of 11 PageID #: 5352
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
BEAUMONT DIVISION
UNITED STATES OF AMERICA,
ex rel. BROOK JACKSON,
Plaintiff,
v. Case No. 1:21-CV-00008-MJT
VENTAVIA RESEARCH GROUP, LLC,
et al.,
Defendants.
_________________________________
UNITED STATES’ MOTION TO INTERVENE
AND TO DISMISS PURSUANT TO 31 U.S.C. § 3730(c)(2)(A)
The United States moves to intervene and dismiss pursuant to 31 U.S.C. §
3730(c)(2)(A) of the False Claims Act (FCA). The United States has good cause to
intervene and is entitled to dismissal of the FCA claims in Relator’s Second
Amended Complaint under United States ex rel. Polansky v. Executive Health
Resources, Inc., 599 U.S. 419 (2023), and the applicable standard of Fed. R. Civ. P.
41(a)(1).
Case 1:21-cv-00008-MJT Document 137 Filed 03/12/24 Page 2 of 11 PageID #: 5353
BACKGROUND
I. FCA Overview
The FCA, 31 U.S.C. §§ 3729-3733, imposes civil penalties and treble
damages on any person or entity that (1) “knowingly presents, or causes to be
presented, a false or fraudulent claim for payment or approval,” in violation of 31
U.S.C. § 3729(a)(1)(A), and (2) “knowingly makes, uses, or causes to be made or
used, a false record or statement material to a false or fraudulent claim,” in violation
of § 3729(a)(1)(B). Civil suits to enforce the FCA may be brought either by the
Attorney General, id. § 3730(a), or by a private person who files suit “for the person
and for the United States Government” in the name of the United States, id.
§ 3730(b)(1). The private person is known as a “relator” and the suit is called a qui
tam action. Id.
After a period for investigation, the FCA requires the United States to notify
the court whether it will intervene in the qui tam action or decline to take over the
action. 31 U.S.C. § 3730(b)(4). Where the United States intervenes, the
Government assumes “the primary responsibility for prosecuting the action” and is
not bound by any act of the relator. Id. § 3730(c)(1). As the party with primary
responsibility over the action, the United States may proceed with the action, settle
the case over the relator’s objection, id. § 3730(c)(2)(B), or dismiss the case over the
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relator’s objection, id. § 3730(c)(2)(A). If the United States declines to intervene,
“the person bringing the action shall have the right to conduct the action.” Id.
§ 3730(b)(4). But even after declining to intervene, the United States may still
intervene “upon a showing of good cause,” 31 U.S.C. § 3730(3), in which case it
then assumes primary responsibility for the action and assumes all of the same rights
described above.
II. Relator’s Qui Tam Allegations
Relator Brook Jackson filed her qui tam action on January 8, 2021, against
Pfizer, Inc.; Icon PLC; and her former employer, Ventavia Research Group, LLC.
Dkt. 2. Relator Jackson alleged that defendants violated the protocol for the Pfizer-
BioNTech COVID-19 vaccine clinical trial at three study sites in Texas and that
defendant Pfizer misrepresented the safety and efficacy of the Pfizer-BioNTech
COVID-19 vaccine to the Food and Drug Administration (FDA). Id.
The United States declined to intervene on January 18, 2022. Dkt. 13. On
February 22, 2022, Relator Jackson filed an amended complaint that was
substantially similar to the original complaint. Dkt. 17. Motion to dismiss briefing
concluded on September 20, 2022. Dkt. 37, 50-51, 53. The United States filed a
Statement of Interest Supporting Dismissal of the Amended Complaint on October
4, 2022. Dkt. 70.
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The Court granted defendants’ motions to dismiss on March 31, 2023. Dkt.
96. On April 28, 2023, Relator Jackson filed a Rule 59(e) Motion to Amend the
Court’s Order of Dismissal and permit her leave to file a second amended complaint
asserting an alternative theory that Pfizer knowingly submitted false or fraudulent
data to FDA, thereby fraudulently inducing the agency’s issuance of Emergency Use
Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine and improperly
rendering it eligible for subsequent payment by the Government. Dkt. 97. The Court
granted Relator Jackson leave to file a second amended complaint on August 9,
2023. Dkt. 108. She filed her Second Amended Complaint on October 5, 2023.
Dkt. 118. The Second Amended Complaint alleges that Pfizer fraudulently induced
the FDA’s issuance of EUA by failing to disclose clinical trial protocol violations,
submitting false data to FDA, and failing to disclose the existence of effective
alternative treatments for COVID-19. Id. Relator Jackson also alleges a series of
flaws in the design, conduct, and analysis of the Pfizer-BioNTech COVID-19
vaccine clinical trial. Id. Defendants moved to dismiss the Second Amended
Complaint on October 20, 2023. Dkt. 119, 120, 121. Relator Jackson filed her
Opposition to Defendants’ Motions to Dismiss on December 19, 2023. Dkt. 127.
Defendants filed their Replies in support of their motions to dismiss on January 19,
2024. Dkt. 129, 130, 132.
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ARGUMENT
I. The United States Has Good Cause To Intervene for the Purpose of
Dismissal
The Supreme Court held in Polansky that if the United States wishes to
dismiss a qui tam suit pursuant to § 3730(c)(2)(A), it must first intervene and
become a party. Polansky, 599 U.S. at 430-31. The FCA provides that the United
States may intervene in a qui tam suit after declining upon a showing of "good
cause." 31 U.S.C. § 3730(c)(3). In its decision that the Supreme Court affirmed
“across the board,” the Third Circuit explained that “showing ‘good cause’ is
neither a burdensome nor unfamiliar obligation,” but instead “a uniquely flexible
and capacious concept, meaning simply a legally sufficient reason.” United States
ex rel. Polansky v. Executive Health Resources, Inc., 17 F.4th 376, 387 (3d Cir.
2021), aff’d 599 U.S. 419 (2023).
This flexible standard for evaluating “good cause” applies even at a later
stage in a qui tam litigation. Polansky, 17 F.4th at 381-82 (noting that “the parties
and the District Court invested considerable time and resources in the case.”). In
ultimately upholding dismissal in Polansky, the Supreme Court recognized that
“the Government’s interest in the suit is the same [at any stage] – and is the
predominant one.” Polansky, 599 U.S. at 434. Qui tam suits are “brought in the
name of the Government” and “the injury they assert is exclusively to the
Government.” Id. at 424–25 (citing § 3730(b)(1)).
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In this case, the United States has good cause to intervene because it seeks to
dismiss Relator Jackson’s Second Amended Complaint. As the Third Circuit
concluded in Polansky, the Government’s request to dismiss the suit “itself
establishes good cause to intervene.” Polansky, 599 U.S. at 429 n.2; see Brutus
Trading, LLC v. Standard Chartered Bank, No. 20-2578, 2023 WL 5344973, at *2
(2d Cir. Aug. 21, 2023) (government’s (c)(2)(A) motion amounted to a motion to
intervene as well); United States ex rel. Carver v. Physicians Pain Specialists of
Alabama, P.C., 2023 WL 4853328, at *6 n.4 (11th Cir. July 31, 2023) (ruling that
“the same grounds that support dismissal also provide good cause to intervene”).
II. Legal Standard for the United States’ Motion to Dismiss Relator’s FCA
Claims
Once the United States intervenes in a qui tam action, the FCA authorizes it
to dismiss such an action, even if the relator objects: “The Government may dismiss
the action notwithstanding the objections of the person initiating the action if the
person has been notified by the Government of the filing of the motion and the court
has provided the person with an opportunity for a hearing on the motion.” 31 U.S.C.
§ 3730(c)(2)(A).
The Supreme Court’s recent decision in Polansky held that district courts
should apply the standard of Rule 41(a) when evaluating a motion to dismiss under
§ 3730(c)(2)(A). 599 U.S. at 424. (“We … hold that in handling such a motion,
district courts should apply the rule generally governing voluntary dismissal of suits:
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Federal Rule of Civil Procedure 41(a)”). If the United States moves to dismiss
before the defendants have served an answer or a motion for summary judgment, as
the United States is doing here, then dismissal may be accomplished merely by the
filing of a “notice of dismissal.” Fed.R.Civ.P. 41(a)(1). The district court “has no
adjudicatory role” other than to dismiss the action, except where dismissal may
implicate constitutional constraints. Polansky, 599 U.S. at 436 n.4. Indeed, even in
cases where the defendant has already filed an answer and the United States seeks
dismissal under Rule 41(a)(2), a motion to dismiss under § 3730(c)(2)(A) “will
satisfy Rule 41 in all but the most exceptional cases.”1 Id. at 437.
Here, the Government investigated and evaluated the claims alleged by the
Relator in her original and amended complaints. While a defendant’s fraud in
inducing FDA to authorize or approve a product may be the basis for a viable FCA
claim, here, FDA was aware of Relator’s allegations of clinical trial protocol
violations that she witnessed at Ventavia prior to the initial EUA. Further, FDA has
1
Even where the defendant has already answered or moved for summary
judgment, the standard remains quite deferential to the government's determination
that that dismissal is warranted. Dismissal in such cases is governed by Rule
41(a)(2), and it is warranted “on terms that the court considers proper.” The
Supreme Court indicated that that standard would be met so long as the United States
provides good grounds for thinking that [the] suit would not do what all qui tam
actions are supposed to do: vindicate the Government’s interests. “Absent some
extraordinary circumstances, that sort of showing is all that is needed for the
Government to prevail on a [section 3730(c)(2)(A)] motion to dismiss.” Polansky,
599 U.S. at 438.
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had continued access—as the information has become available—to the Pfizer
COVID-19 vaccine clinical trial protocol and results, reported adverse event data,
and scientific research that Relator identifies to support her fraudulent inducement
claim. As recently as January 5, 2024, FDA Commissioner Robert Califf, MD and
Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, MD,
Ph.D., published an editorial in the Journal of the American Medical Association
reiterating the importance of vaccination, including vaccination to protect against
COVID-19. 2 They noted, “contrary to a wealth of misinformation available on
social media and the internet, data from various studies indicate that since the
beginning of the COVID-19 pandemic tens of millions of lives were saved by
vaccination.” 3 The anticipated discovery and litigation obligations associated with
the continued litigation of this case will impose a significant burden on FDA, HHS,
and DOJ. The United States should not be required to expend resources on a case
that is inconsistent with its public health policy.
III. No In-Person Hearing is Necessary
An in-person hearing is not required and would not aid the Court in
adjudicating the Government’s motion to dismiss. Polansky did not specify what
procedures would satisfy the requirement of a hearing but did not require a hearing
2
Marks P, Califf R. Is Vaccination Approaching a Dangerous Tipping Point?
JAMA. Published online January 05, 2024. doi:10.1001/jama.2023.27685.
3
Id.
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in all matters. In evaluating how a district court should reconcile a relator’s right to
a hearing with the fact that the district court has no adjudicatory role under Rule
41(a)(1), the Supreme Court suggested that a hearing might establish a constitutional
floor, inquiring into any credible allegations that dismissal might “violate the
relator’s rights to due process or equal protection,” but did not elaborate on what
would constitute such a violation. Polansky, 599 U.S. at 436 n.4. Those types of
constitutional concerns clearly are not present in this case. Accordingly, no hearing
is required in this matter. Id.; see Brutus Trading, LLC, 2023 WL 5344973, at *3
(holding that no in-person hearing was required, explaining that “the district court
met the hearing requirement by carefully considering the parties’ written
submissions”); U.S. ex. rel. Guglielmo v. Leidos, Inc., et al., No. 19-1576, D.D.C.
Feb. 20, 2024) (granting the United States’ motion to dismiss under Fed. R. Civ. P.
41(a)(1) without an in-person hearing).
CONCLUSION
For the foregoing reasons, the United States respectfully requests that, finding
the United States had good cause to intervene, the case be dismissed pursuant to 31
U.S.C. § 3730(c)(2)(A).
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Date: March 12, 2024 Respectfully submitted,
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney General
DAMIEN M. DIGGS
United States Attorney
Eastern District of Texas
By: /s/ Erin Colleran
JAMIE ANN YAVELBERG
ANDY J. MAO
ERIN COLLERAN
U.S. Department of Justice
Civil Division
175 N St., NE
Washington, DC 20002
(202) 532-5056
Erin.Colleran@usdoj.gov
JAMES GILLINGHAM
Assistant U.S. Attorney
Eastern District of Texas
110 N. College Street; Suite 700
Tyler, Texas 75702
(903) 590-1400
James.Gillingham@usdoj.gov
Texas State Bar # 2406529
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CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a true and correct copy of the foregoing was served
electronically via CM/ECF to all parties, on this 12th day of March, 2024.
/s/ Erin Colleran
Erin Colleran
Trial Attorney
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