Relator Brook Jackson’s Amended Complaint (Ventavia Research Group, LLC; Pfizer Inc.; ICON PLC), Case 1:21-cv-00008-MJT, Document 17
Summary
Relator Brook Jackson's Amended Complaint under the False Claims Act in the United States District Court for the Eastern District of Texas, Beaumont Division, Case 1:21-cv-00008-MJT, Document 17, filed 02/22/22, against Ventavia Research Group, LLC, Pfizer Inc. and ICON PLC. It alleges the defendants concealed clinical trial protocol and federal regulatory violations, including falsified trial documents, in the BioNTech-Pfizer COVID-19 vaccine trial, after Pfizer contracted with the Department of Defense to supply 100 million doses for $1.95 billion. Jackson, a Ventavia Regional Director at the Keller and Fort Worth sites, alleges fabricated data, enrollment of ineligible participants and failure to maintain the blind, and that Ventavia terminated Jackson in retaliation for reporting fraud. The counts are false claims, false records or statements, and retaliation.
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Case 1:21-cv-00008-MJT Document 17 Filed 02/22/22 Page 1 of 80 PageID #: 696
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
BEAUMONT DIVISION
§
§ RELATOR BROOK JACKSON’S
UNITED STATES OF AMERICA § AMENDED COMPLAINT FOR
ex rel. Brook Jackson, § VIOLATIONS OF THE FEDERAL
§ FALSE CLAIMS ACT
Plaintiff, §
§ CASE NO. 1:21-cv-00008-MJT
v. §
§
§ JURY TRIAL DEMANDED
VENTAVIA RESEARCH GROUP, LLC; §
PFIZER INC.; ICON PLC, §
§
Defendants. §
§
§
§
RELATOR BROOK JACKSON’S AMENDED COMPLAINT
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TABLE OF CONTENTS
I. Introduction to Case ............................................................................................................ 1
II. Jurisdiction and Venue ........................................................................................................ 5
III. Government Plaintiff .......................................................................................................... 5
IV. Introduction to Relator Brook Jackson ............................................................................... 5
A. Relator’s Background ............................................................................................. 5
B. Original Source and Disclosures ........................................................................... 10
V. Defendants ........................................................................................................................ 11
A. Pfizer Inc ............................................................................................................... 11
B. Icon PLC ............................................................................................................... 12
C. Ventavia Research Group, LLC ............................................................................ 12
VI. Respondeat Superior and Vicarious Liability ................................................................... 13
VII. Statutory and Factual Background .................................................................................... 13
A. COVID-19 Vaccine Development ........................................................................ 13
B. FDA Clinical Trial Regulations ............................................................................ 14
C. The BioNTech-Pfizer COVID-19 Vaccine ........................................................... 17
1. Background and Development of BNT162b2 .......................................... 17
2. Clinical Trial Overview ............................................................................ 18
3. Clinical Trial Protocol............................................................................... 20
a. Inclusion and Exclusion Criteria ................................................... 20
b. Blinding......................................................................................... 21
c. Temperature Control ..................................................................... 21
d. Informed Consent.......................................................................... 22
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e. Administration .............................................................................. 22
f. Safety and Monitoring .................................................................. 23
g. Legal and Regulatory Compliance................................................ 24
h. Adherence to Protocol................................................................... 24
i. Accuracy of Data .......................................................................... 25
4. BNT162b2 Product Manual ...................................................................... 25
a. Additional Blinding Precautions ................................................... 26
b. Temperature Excursions ............................................................... 27
c. Dose Preparation ........................................................................... 27
d. Injection ........................................................................................ 28
e. Monitoring .................................................................................... 28
D. Contract at Issue .................................................................................................... 29
1. Background ............................................................................................... 29
2. FAR Compliance ...................................................................................... 30
3. FAR Certification...................................................................................... 30
VIII. Defendants’ Fraud on the Government ............................................................................. 31
A. Violation of Clinical Trial Protocol ...................................................................... 31
1. Inclusion and Exclusion Criteria ............................................................... 31
2. Blinding..................................................................................................... 34
3. Temperature Control ................................................................................. 37
4. Informed Consent...................................................................................... 37
5. Dose Preparation ....................................................................................... 39
6. Administration .......................................................................................... 39
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7. Safety and Patient Monitoring .................................................................. 41
8. Accuracy and Completeness of Data ........................................................ 44
9. Adherence to Protocol............................................................................... 47
10. Privacy Law Compliance .......................................................................... 50
B. Violation of FDA Regulations .............................................................................. 51
C. Violation of FAR .................................................................................................. 52
D. Ongoing Monitoring Concerns ............................................................................. 53
E. Safety and Ethical Issues ...................................................................................... 53
IX. Retaliation Against Relator ............................................................................................... 54
A. Relator begins her efforts to stop fraud against the United States ........................ 56
B. Relator photographs violations ............................................................................. 57
C. Relator recommends pausing clinical trial enrollment.......................................... 60
D. Ventavia management falsely accuses Relator of violating patient
confidentiality ....................................................................................................... 63
E. Ventavia terminates Relator the next day ............................................................. 64
X. Actionable Conduct by Defendants .................................................................................. 66
A. False Claims Act ................................................................................................... 66
1. Applicable Law ......................................................................................... 66
2. Defendants’ Violations of the False Claims Act ....................................... 67
a. Presentation of False Claims: 31 U.S.C. § 3729(a)(1)(A) ............ 67
b. Making or Using False Records or Statements to Cause
Claims to be Paid: 31 U.S.C. § 3729(a)(1)(B) .............................. 69
c. Retaliation: 31 U.S.C. § 3730(h)................................................... 70
XI. Causes of Action ............................................................................................................... 71
iv
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A. Count I – Presentation of False and/or Fraudulent Claims (31 U.S.C. §
3730(a)(1)(A))....................................................................................................... 71
B. Count II – Making or Using False Records or Statements Material to False
and/or Fraudulent Claims (31 U.S.C. § 3730(a)(1)(B)) ........................................ 71
C. Count III – Retaliation (31 U.S.C. § 3730(h)) ...................................................... 73
XII. Index of Exhibits ............................................................................................................... 74
XIII. Demand for Jury Trial ....................................................................................................... 75
v
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1. Plaintiff/Relator Brook Jackson (“Jackson” or “Relator”) brings this action
pursuant to the False Claims Act, 31 U.S.C. §§ 3729–3732, and seeks to recover all damages,
penalties, and other remedies established by the False Claims Act on behalf of the United States
of America and on her own behalf. Relator would respectfully show the following:
I. INTRODUCTION TO CASE
2. Developing a safe and effective vaccine against the novel Coronavirus (“COVID-
19”) was a matter of urgency. But that urgency does not excuse cutting corners in clinical trials,
wasting taxpayer dollars, violating federal regulations, and possibly endangering Americans’
health. Defendants Pfizer Inc., Icon PLC, and Ventavia Research Group, LLC (collectively,
“Defendants”) conducted a clinical trial to test one of the COVID-19 vaccine candidates. In the
race to secure billions in federal funding and become the first to market, Defendants deliberately
withheld crucial information from the United States that calls the safety and efficacy of their
vaccine into question. Namely, Defendants concealed violations of both their clinical trial protocol
and federal regulations, including falsification of clinical trial documents. Due to Defendants’
scheme, millions of Americans have received a government-funded misbranded vaccination
which posed the risk of being less effective than represented - a risk that has since become a
reality. The vaccine’s U.S. Food and Drug Administration (“FDA”) authorization resulted from a
deeply flawed clinical trial that violated FDA regulations. Defendants have profited from the
COVID-19 pandemic at the expense of the United States and its citizens by abusing the scientific
process.
3. BioNTech SE (“BioNTech”) and Defendant Pfizer Inc. (“Pfizer”) co-developed a
messenger RNA vaccine against COVID-19. After a reportedly successful Phase 1 clinical trial,
Pfizer entered into a contract with the United States Department of Defense (“DoD”), under which
DoD would purchase 100 million doses of the vaccine for $1.95 billion following FDA approval
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or Emergency Use Authorization (“EUA”). Pfizer and BioNTech became co-sponsors of Phase 2
and 3 clinical trials for their vaccine, aiming for FDA approval or EUA status.
4. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon
PLC (“Icon”), an Irish clinical research organization. Icon was tasked with oversight of over 160
test sites worldwide, ensuring trial protocol compliance, and ensuring reporting of required
information. This includes oversight of Serious Adverse Event (“SAE”) reporting, which is
required by the trial protocol and federal regulations. Pfizer remained responsible for managing
and quality checking all data for the entire clinical trial, per the trial’s protocol.
5. Defendant Ventavia Research Group, LLC (“Ventavia”) was contracted by Pfizer
to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas.
Ventavia ultimately enrolled about 1,500 clinical trial patients. Ventavia employed Relator
Jackson as a Regional Director. She was tasked with overseeing site management, patient
enrollment, quality assurance completion, event reporting, corrective action plan creation,
communication with management, and staff training completion at the Keller and Fort Worth sites.
6. Pfizer, aiming for the title of “first successful COVID-19 vaccine,” pushed
Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. Ventavia
was compensated by Pfizer mainly on a per-patient basis—up to a weekly limit—and rushed to
enroll as many clinical trial participants as possible per week. Ventavia’s race to maximize
payment and over-booking of patients resulted in sloppy and fraudulent documentation practices,
poor clinical trial protocol compliance, and little oversight. Pfizer and Icon turned a blind eye to
Ventavia’s misconduct, despite numerous warning signs.
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7. Ventavia’s trial protocol and regulatory violations were so widespread, in fact, that
Relator observed them on a near-daily basis during her brief employment period. For example,
Relator observed:
• fabrication and falsification of blood draw information, vital signs, signatures and other
essential clinical trial data;
• enrollment and injection of ineligible clinical trial participants, including Ventavia
employees’ family members;
• failure to timely remove ineligible patients’ data from the trial;
• failure to maintain temperature control for the vaccine at issue;
• failure to monitor patients after injection as required by the trial protocol;
• principal investigator oversight failures;
• use of unqualified and untrained personnel as vaccinators and laboratory personnel;
• failure to maintain the “blind” as required, which is essential to the credibility and validity
of the observer-blinded clinical trial;
• ethical violations, such as failure to secure informed consent and giving patients
unapproved compensation;
• improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the
wrong needle size);
• failure to ensure that trial site staff were properly trained as required by good clinical
practices;
• safety and confidentiality issues, including HIPAA violations; and
• other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition
Regulations and their DoD supplements.
8. Ventavia failed to report the majority of its clinical trial protocol and regulatory
violations to Pfizer or the external Institutional Review Board. Issues were improperly
documented or hidden away in “notes to the file,” and not corrected.
9. Icon and Pfizer communicated with each trial site to monitor compliance, but failed
to follow up on missing information, ignored “red flags” of trial protocol violations and false data,
and failed to exclude ineligible participants from the trial data. In Pfizer’s rush to be the “first,” it
failed to address violations that compromised its entire clinical trial, including those raised by
Relator. This resulted in Pfizer withholding material information from the United States, and
submitting false data and records in its clinical trial results.
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10. Relator reported many of the violations she observed to Ventavia management, who
allowed the majority of violations to continue unabated. Defendant Ventavia harassed Relator and
terminated her in retaliation for her reports of and efforts to stop fraud against the United States
DoD. Relator also reported her concerns to Pfizer after termination, yet Pfizer elected to press on,
expanding its trial to include even more participants.
11. Although Relator’s experience with test sites is limited to Texas, Pfizer and Icon’s
oversight failures and fraudulent misconduct vis-a-vis Ventavia bring the entire Pfizer-BioNTech
clinical trial into question. It is likely that similar fraud occurred at clinical trial sites managed by
other subcontractors of Pfizer.
12. The FDA has issued three EUAs for the Pfizer-BioNTech vaccine for different age
cohorts: the first on December 11, 2020 for individuals 16 years of age and older; the second on
May 10, 2021 for individuals 12 years of age and older; and the third on October 29, 2021 for
children 5 through 11 years of age. Furthermore, on August 23, 2021 the FDA concurrently
granted a biologic license for Pfizer’s COMIRNATY vaccine and reissued it EUAs. The
authorizations and approval are based in part on Defendants’ falsified clinical trial results and
concealment of key information. As a result, DoD has now purchased misbranded vaccines
from Defendant Pfizer, relying on Defendants’ fraudulent misrepresentations that the vaccine trial
was properly conducted. Had DoD known of Defendants’ clinical trial protocol violations,
fraudulent conduct, and regulatory violations, it would not have purchased the vaccines.
13. Defendants’ fraudulent scheme caused DoD to pay billions that it would not have
paid had it known that the safety and efficacy of the vaccine at issue was not properly proven. At
worst, the vaccine could be far less effective than represented, and DoD purchased a product that
will not protect the public from COVID-19 as effectively as claimed and instead could result in
substantial nationwide harm from a fraudulently tested pharmaceutical drug. At best, the
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vaccine is effective, but Defendants have profited from the COVID-19 pandemic by lying to the
United States, violating federal regulations, and failing to uphold the integrity of the scientific
process.
II. JURISDICTION AND VENUE
14. Jurisdiction and venue are proper in the Eastern District of Texas pursuant to 31
U.S.C. § 3732(a) because Relator’s claims seek remedies on behalf of the United States for
multiple violations of 31 U.S.C. §§ 3729–3732 in Texas by Defendants that damaged the United
States government.
15. Defendants Pfizer, Inc. and Ventavia do business in Texas and are registered with
the Texas Secretary of State.
16. Defendant Icon PLC conducts continuous and systematic business in Texas. It
maintains corporate offices in San Antonio and Sugar Land, Texas, and employs hundreds of
Texans statewide, including in this District. Icon PLC also oversees and manages clinical trial
sites in Texas and in this District.
17. Defendants are therefore subject to general and specific personal jurisdiction
pursuant to 31 U.S.C. § 3732(a) and 28 U.S.C. § 1367.
III. GOVERNMENT PLAINTIFF
18. The Government Plaintiff in this lawsuit is the United States of America.
IV. INTRODUCTION TO RELATOR BROOK JACKSON
A. Relator’s Background
19. Relator Brook Jackson (“Relator” or “Jackson”) has worked in the clinical trials
field for over eighteen years. She is a Clinical Research Auditor and Certified Clinical Research
Professional. Before working for Defendant Ventavia Research Group, LLC (“Ventavia”),
Jackson served as the Director of Operations for a multi-state clinical trial company. Second only
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to the CEO, she oversaw legal and regulatory compliance, adherence to good clinical practices,
submission of required documentation, and business development across the company.
20. Because Relator’s prior position required a great deal of travel, she decided to
leave that company and begin working for Ventavia. Relator began her employment with
Ventavia on September 8, 2020 as a Regional Director.
21. As Regional Director, Relator oversaw site managers, patient recruitment success,
training completion, quality assurance completion, enforcement of communication paths, and
growth plans at her assigned test sites. Relator’s job duties also included daily and weekly
communication with the site operations managers of her assigned test sites and Ventavia’s
leadership team. Relator was responsible for the duties above at two of Ventavia’s three test sites
for the clinical trial at issue, located in Fort Worth and Keller, Texas.
22. Relator’s direct supervisor during her employment with Ventavia was Director of
Operations Marnie Fisher (“Fisher”). Her other superiors were Ventavia’s Executive Directors
Olivia Ray (“Ray”) and Kristie Raney (“Raney”) and the Chief Operating Officer, Mercedes
Livingston (“Livingston”).
23. Beginning on September 8, 2020, Relator reported on a near-daily basis to Fisher
and Livingston that patient safety and the integrity of the Pfizer-BioNTech vaccine trial was at
risk, via telephone, conversation, and e-mail. Relator discussed virtually all of the clinical trial
protocol and FDA regulatory violations she witnessed with Livingston, Ray, Raney, and Fisher,
including, but not limited to: (1) enrollment and injection of ineligible trial participants; (2)
falsification of data, poor recordkeeping, and the deficiency of Ventavia’s documentation “quality
control”; (3) deficiencies in and failure to obtain informed consent from trial participants; (4)
adverse event capture and reporting; (5) failure to preserve blinding; (6) vaccine dilution errors;
(7) failure to list all staff on delegation logs; (8) principal investigator oversight; (9) reporting
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temperature excursions; (10) patient safety issues, such as not keeping epinephrine dose
information in patient charts; (11) failure to secure and record staff training required by clinical
research standards; (12) use of unqualified staff as vaccinators; (13) use of biohazard bags for
needle disposal; and (14) failure to properly monitor patients post-injection.
24. In general, every time that Relator raised concerns about safety or Ventavia’s
clinical trial protocol compliance with Fisher, she was told to e-mail Fisher about the issue or make
a list of affected patients. Many of the identified issues were systemic, and Relator did not always
have access to information required to make the lists Fisher requested. Relator did as Fisher
requested to the extent that she was able, but the identified problems were never addressed.
25. Relator also reported some clinical trial protocol violations to the Fort Worth
Principal Investigator, Dr. Mark Koch. In particular, Relator discussed Ventavia’s practice of
“quality checking” patient source documents long after the fact and issues of missing
documentation. Dr. Koch acknowledged that Ventavia needed to “clean up” the problems before
starting any new clinical trials.
26. Ventavia was required to scan or enter all data from clinical trial participants’
source documents into the “Complion” Clinical Trial Management System database, so that it
could be passed on to Icon and Pfizer. Ventavia “quality checked” all source documents before
scanning or uploading them. In Ventavia’s scramble to enroll as many participants as possible,
quality checking and uploading fell behind schedule. Relator observed that the “back log” of
documents to be quality checked often lacked key information, such as patient or doctor signatures
and blood draw times. Relator also observed that Ventavia’s quality checking process was
performed by unqualified personnel not listed on delegation logs, and often involved falsification
of missing data. Relator reported her concerns to Ventavia management, who was more concerned
with “catching up” on quality checking than actually solving the problem.
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27. On September 16, 2020, Relator examined some of the biohazard disposal bags at
Ventavia’s Fort Worth site. Relator discovered that used needles had been disposed of in the bags.
Biohazard bags are not puncture-proof, so this presented a serious risk to employees’ safety. That
same night, Relator photographed ongoing HIPAA violations. Relator also documented that
product cartons and patient randomization numbers from the BioNTech-Pfizer vaccine trial had
been left in public view in a preparation area, potentially unblinding all Ventavia staff at the site
and some patients as well. Relator shared her photographs from September 16 with Livingston
and Fisher via text message or e-mail.
28. On September 17, 2020, in her daily phone call with Ray, Raney, Fisher,
Livingston, and Houston Regional Director Lovica “Kandy” Downs (“Downs”), Relator brought
up virtually all of the protocol and regulatory violations she had witnessed to date, as well as
Ventavia’s HIPAA violations. Relator explained that the FDA would likely issue warning letters
against Ventavia if it visited or audited the trial sites. She recommended that Ventavia immediately
stop enrollment in the Pfizer-BioNTech clinical trial.
29. Ventavia shortly thereafter decided to pause enrollment in order to catch up on
“quality checking” source documents. Ventavia was not up-front with Pfizer and Icon about the
reasons for the enrollment pause (sloppy documentation that violated the clinical trial protocol).
Ventavia elected to schedule patients for several weeks later rather than truly and completely pause
enrollment. See Ex. 1, Text Messages with Ray and Others, at 6, 9–10. Raney directed employees
not to cancel any patients already “on their way” to test sites because “that might piss them off and
they can call the news, etc[.]” Ex. 1, at 11.
30. During the enrollment pause, Ventavia’s “quality checking” not only failed to
correct documentation violations but also involved falsification of missing or inconsistent data.
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Relator even personally observed employees falsifying source document data (i.e., by changing
blood pressure readings). In short, Ventavia’s “quality checking” failed to prevent or stop fraud
on the United States DoD.
31. On September 23, 2020, Relator e-mailed Ray, Fisher, Raney, Downs, Livingston,
and Director of Quality Control William Jones (“Jones”) to report ongoing serious issues with
Ventavia’s “quality checking.” See Ex. 2, E-mail Chain with Ray and Others (Sept. 23, 2020).
Relator noted, for example, that multiple patients had not received their second dose of the vaccine
in the required window of nineteen to twenty-three days, and that Ventavia had not truthfully
recorded the delay. Id. Due to the seriousness of these violations, Relator stated, “I might be in a
little bit of shock.” Ex. 2, at 1.
32. On the evening of September 24, 2020, Relator met with Fisher and Jones. See Ex.
3, Transcript of September 24, 2020 Meeting Recording. The meeting was arranged to discuss
Relator’s photographic documentation of safety issues, HIPAA violations, and unblinding from
September 16. The meeting quickly escalated into harassment. Fisher questioned repeatedly why
Relator took the photographs and falsely accused Relator of removing patient source documents
from another Ventavia location. Jones stated that Ventavia had not “even finished quantifying the
number of errors” because “it’s something new every day.” Ex. 3, at 12. He acknowledged that
the problems were “not just in one site” either, and stated “we’re gonna get some kind of letter of
information at least, when the FDA gets here. Know it.” Id.
33. Relator specifically referenced FDA regulatory violations in her September 24
conversation with Fisher and Jones. She told Fisher and Jones that if they did not see what she
saw when quality checking patients’ source documents, then they needed to “get on Google” and
search for FDA warning letters. Ex. 3, at 14. Relator also reported to Fisher and Jones that Raney
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and Ray had acknowledged that Ventavia did not have the staff or patient room capacity to handle
the number of clinical trial participants being seen every day.
34. On the following morning, Relator called the FDA’s hotline to report the clinical
trial protocol violations and patient safety concerns she witnessed. Relator was terminated from
her position at Ventavia that same day—September 25, 2020—under the pretext that she was “not
a good fit.” Relator had never been formally disciplined or reported for any failure regarding her
job performance.
35. After Relator was terminated, she called Ventavia’s contact at Pfizer and gave a
general overview of her concerns about unblinding, principal investigator oversight, and patient
safety in the Pfizer-BioNTech vaccine trial. She also informed Pfizer that she had contacted the
FDA.
36. Almost immediately after Relator was terminated (the next business day), Ventavia
lifted the enrollment “pause” and resumed the push to enroll as many clinical trial participants per
week as possible. Given the amount of quality checking left to be performed when Relator was
terminated, Relator estimates that Ventavia had neither completed quality checking nor remedied
its ongoing violations by the time it resumed enrollment.
37. Ventavia retaliated against Relator in response to her reports of, and efforts to stop,
fraud against the United States DoD resulting from the Pfizer-BioNTech COVID-19 vaccine trial.
B. Original Source and Disclosures
38. There are no bars to recovery under 31 U.S.C. § 3730(e), and, or in the alternative,
Relator is an original source as defined therein. Relator has direct and independent knowledge of
the information on which she bases her allegations. To the extent that any allegations or
transactions herein have been publicly disclosed, Relator has independent knowledge that
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materially adds to any publicly disclosed allegations or transactions and has provided this
information to the United States and DoD prior to filing a complaint by serving a voluntary pre-
filing disclosure statement.
39. Relator will submit an original disclosure statement, as well as substantially all
material evidence and information, to the Attorney General of the United States, Department of
Justice, and United States Attorney for the Eastern District of Texas contemporaneously with the
service of this Original Complaint.
V. DEFENDANTS
A. Pfizer Inc.
40. Pfizer Inc. (“Pfizer”) is a Delaware corporation headquartered at 235 East 42nd
Street, New York, New York 10017-5703. It maintains an office in this District at 1301 Solana
Boulevard, Westlake, Texas 76262. Pfizer, together with BioNTech, developed the vaccine at
issue and co-sponsors the clinical trial at issue.
41. Pfizer is publicly-traded on the New York Stock Exchange under the ticker symbol
“PFE.”
42. The United States Department of Defense has contracted with Pfizer to purchase
200 million doses of the vaccine at issue after FDA approval, for a total cost of $3.9 billion.
43. Pfizer is currently subject to a Corporate Integrity Agreement with the Office of the
Inspector General of the U.S. Department of Health and Human Services, dated May 23, 2018.1
44. Pfizer may be served through its registered agent, CT Corporation System, at 1999
Bryan Street, Suite 900, Dallas, Texas 75201.
1
Available at https://oig.hhs.gov/fraud/cia/agreements/Pfizer_Inc_05232018.pdf
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B. Icon PLC
45. Icon PLC (“Icon”) is an Irish company headquartered in Dublin. Icon conducts
extensive business in the United States and Texas, including at its offices in Sugar Land and San
Antonio, Texas. Icon has hundreds of employees in Texas, including in this District, and oversees
and manages clinical trials statewide.
46. Icon is publicly-traded on the NASDAQ stock exchange under the ticker symbol
“ICLR.”
47. Defendant Pfizer subcontracted Icon to manage the clinical trial at issue. Icon
oversaw more than 160 test sites worldwide, and was tasked with ensuring clinical trial protocol
compliance and required information reporting.
48. Icon may be served at South County Business Park, Leopardstown, Dublin 18,
Ireland.
C. Ventavia Research Group, LLC
49. Ventavia Research Group, LLC (“Ventavia”) is a Texas limited liability company
headquartered at 1307 Eighth Avenue, Suite 202, Fort Worth, Texas 76104. Ventavia operates ten
test sites in Texas, some of which are located in this District. Three of Ventavia’s test sites—in
Keller, Fort Worth, and Houston—participated in the vaccine trial at issue.
50. Ventavia secured its contract to operate three test sites for the Pfizer-BioNTech
vaccine trial through its contracting agent Platinum Research Network, LLC, and was paid directly
by Defendant Pfizer for that work. Pfizer compensated Ventavia mainly on a per-patient basis,
with additional amounts paid per Serious Adverse Event reported and for activities like training.
51. Ventavia recorded all key participant and clinical trial information in “source
documents” made available to Pfizer and Icon after entry or upload.
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52. Ventavia may be served through its registered agent, Registered Agents Solutions
Inc., at 1701 Directors Boulevard, Suite 300, Austin, Texas 78744.
VI. RESPONDEAT SUPERIOR AND VICARIOUS LIABILITY
53. Any and all acts alleged herein to have been committed by Defendants were
committed by officers, directors, employees, representatives, or agents, who at all times acted on
behalf of Defendants and within the course and scope of their employment, or by corporate
predecessors to whom successive liability applies.
VII. STATUTORY AND FACTUAL BACKGROUND
A. COVID-19 Vaccine Development
54. On May 15, 2020, the White House announced Operation Warp Speed (“OWS”), a
partnership between the United States Department of Health and Human Services (“HHS”) and
the United States Department of Defense (“DoD”).
55. OWS aimed to begin delivery of 300 million doses of FDA-authorized COVID-19
vaccines by January of 2021. HHS, Fact Sheet: Explaining Operation Warp Speed (Nov. 30,
2020).2 OWS coordinates with and expands existing HHS programs, including the National
Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”)
partnership. Id.
56. OWS’s main initiative has been contracting with pharmaceutical companies to fund
clinical trials of or purchase promising COVID-19 vaccine candidates. Purchases only occur after
those vaccine candidates secure approval or Emergency Use Authorization from the United States
Food and Drug Administration (“FDA”). The vaccine at issue is part of one such contract,
explained further infra.
2
https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html.
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B. FDA Clinical Trial Regulations
57. The FDA promulgates regulations applicable to all clinical trials of new drugs like
the vaccine at issue. See 21 C.F.R. §§ 312.1 et seq. These regulations apply with equal force to
COVID-19 vaccine trials, despite their accelerated nature and the pandemic emergency. See 42
U.S.C. § 247d-6d(c)(5)(C)(i).
58. Clinical trial sponsors like Pfizer must submit an Investigational New Drug
Application (“IND”) before commencing the trial. See 21 C.F.R. § 312.23(a). An example IND
(Form FDA-1571) is attached hereto as Exhibit 4. In the IND, the sponsor commits to conduct the
trial “in accordance with all [] applicable regulatory requirements.” 21 C.F.R. § 312.23(a)(v); Ex.
4, Form FDA-1571, at 2. The IND form warns clinical trial sponsors that making a “willfully false
statement is a criminal offense.” Ex. 4, at 2.
59. Clinical trial sponsors must utilize an Institutional Review Board (“IRB”) for initial
and continuing review and approval of the clinical trial. See 21 C.F.R. § 312.23(a)(iv). The
sponsor must report “all changes in the research activity” to the IRB, along with “all unanticipated
problems involving risk to human subjects or others.” 21 C.F.R. § 312.66. The sponsor must
assure that it “will not make any changes to research without IRB approval, except where
necessary to eliminate apparent immediate hazards to human subjects.” Id. (emphasis added).
60. The sponsor must promptly investigate “all safety information it receives” and
follow up on any adverse reactions. 21 C.F.R. § 312.32(d)(1). The sponsor must also review all
safety and effectiveness information reported by contract investigators (i.e., clinical trial sites).
The sponsor must notify the FDA of potential serious risks and adverse reactions. See 21 C.F.R.
§ 312.32(c).
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61. If a study sponsor utilizes contract investigators for its clinical trial (like how Pfizer
contracted with Icon and Ventavia here), it must ensure that the investigator is qualified, provide
the investigator with the information needed to properly conduct a clinical trial, ensure proper
monitoring of the trial, ensure that the trial complies with the IND and clinical trial protocol, and
ensure “that FDA and all participating investigators are promptly informed of significant new
adverse effects or risks” with respect to the drug under investigation. 21 C.F.R. § 312.50.
62. The sponsor must obtain a signed Form FDA-1572 from each contract investigator.
21 C.F.R. § 312.53(c). In Form FDA-1572, each investigator certifies, in relevant part, that it:
(a) Will conduct the study(ies) in accordance with the relevant, current
protocol(s) and will only make changes in a protocol after notifying the sponsor,
except when necessary to protect the safety, the rights, or welfare of subjects;
(b) Will comply with all requirements regarding the obligations of clinical
investigators and all other pertinent requirements in [21 C.F.R. part 312];
(c) Will personally conduct or supervise the described investigation(s);
(d) Will inform any potential subjects that the drugs are being used for
investigational purposes and will ensure that the requirements relating to obtaining
informed consent (21 CFR part 50) and institutional review board review and
approval (21 CFR part 56) are met;
(e) Will report to the sponsor adverse experiences that occur in the course of
the investigation(s) in accordance with § 312.64; . . . [and]
(g) Will ensure that all associates, colleagues, and employees assisting in the
conduct of the study(ies) are informed about their obligations in meeting the above
commitments.
21 C.F.R. § 312.53(c)(vi); see also Ex. 5, Form FDA-1572. Each contract investigator also
commits in Form FDA-1572 to promptly report to the IRB “all changes in the research activity
and all unanticipated problems involving risks to human subjects or others[.]” 21 C.F.R. §
312.53(c)(vii). The contract investigators further commit to not making any research changes
without IRB approval “except where necessary to eliminate apparent immediate hazards to the
human subjects.” Id. The Form warns contract investigators that a “willfully false statement is a
criminal offense.” Ex. 5, at 2.
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63. The sponsor must monitor its contract investigators’ progress and compliance with
the clinical trial protocol, IND, and all applicable regulations. See 21 C.F.R. §§ 312.50, 312.56.
“A sponsor who discovers that an investigator is not complying” with those requirements “shall
promptly either secure compliance or discontinue shipments of the investigational new drug to the
investigator and end the investigator’s participation in the [clinical trial].” 21 C.F.R. § 312.56(b).
Contract investigators are bound by the same regulations as the sponsor, to the same degree, with
regard to any obligation the sponsor delegates to them. See 21 C.F.R. § 312.52.
64. Thus, in the clinical trial at issue, all Defendants are bound by FDA regulations and
“subject to the same regulatory action . . . for failure to comply[.]” 21 C.F.R. § 312.52(b). Failure
to comply with FDA regulations or submission of false information to the trial sponsor or FDA
can disqualify a company from conducting future clinical trials. See 21 C.F.R. § 312.70(b).
65. Contract investigators are obligated to “furnish all reports to the sponsor.” 21
C.F.R. § 312.64(a). The sponsor “is responsible for collecting and evaluating the results obtained.”
Id.
66. Contract investigators must maintain adequate records of drug dispensation,
“including dates, quantity, and use by subjects.” 21 C.F.R. § 312.62(a). They must also keep
“adequate and accurate case histories” for all study participants which “record all observations and
other data pertinent to the investigation[.]” 21 C.F.R. § 312.62(b).
67. Informed consent must be obtained and documented for every participant in the
clinical trial. See 21 C.F.R. §§ 50.27(a), 312.60, 312.62(b). The investigator must document “that
informed consent was obtained prior to participation in the study.” 21 C.F.R. § 312.62(b)
(emphasis added).
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68. The clinical trial drug (here, the vaccine at issue) shall only be given to subjects
under an investigator or sub-investigator’s personal supervision. See 21 C.F.R. § 312.61. It shall
not be given to any person not authorized to receive it. Id.
69. Contract investigators must immediately report any Serious Adverse Event
(“SAE”) to the sponsor, “whether or not considered drug related, . . . and must include an
assessment of whether there is a reasonable possibility that the drug caused the event.” 21 C.F.R.
§ 312.64(b). Nonserious adverse events must also be reported to the sponsor. Id.
70. SAEs have the potential to pause clinical trials if sufficiently serious. See 21 C.F.R.
§ 312.44. In fact, two of Pfizer’s competitors in the COVID-19 vaccine race—Astra Zeneca and
Johnson & Johnson—had to pause their own clinical trials when participants developed
unexplained illnesses.
C. The BioNTech-Pfizer COVID-19 Vaccine
1. Background and Development of BNT162b2
71. BNT162b2, the vaccine at issue, is a biologic vaccine co-developed by BioNTech
and Defendant Pfizer which is based on a platform of nucleoside-modified messenger RNA
(“mRNA”).
72. Most conventional vaccines are based on weakened strains of the virus at issue.
Those vaccines essentially “teach” the body how to fight the weakened virus, resulting in
production of antigens to combat future infection.
73. BNT162b2, in contrast, is based on mRNA—molecules of genetic material—from
the novel Coronavirus. The vaccine causes the body’s cells to produce viral proteins, and the body
then produces an immune response. In this way, the body is “taught” how to fight the virus’s
proteins, rather than a weakened version of the virus itself. One purported advantage of mRNA
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vaccines is that there is no risk of infection because they do not contain the actual virus—just parts
of its genetic material.
74. One drawback of mRNA vaccines like BNT162b2—and one reason that they are
not widespread—is that they must be stored at more controlled temperatures than conventional
vaccines. BNT162b2 specifically must be stored in medical-grade freezers at –112°F to –76°F. It
may also be shipped and stored short-term in a specialized cooler with dry ice (solid carbon
dioxide) for up to ten days unopened.
75. Because BNT162b2 is stored at such low temperatures, it must be thawed before
use. The placebo used in the BNT162b2 clinical trial does not require such thaw time. In order to
preserve patient blinding in the BNT162b2 clinical trial, waiting times for both the vaccine and
placebo are standardized at thirty minutes or more, and the syringe is covered by an opaque label
during injection. See Ex. 6, BNT162b2 Product Manual, at 34, 48–49.
2. Clinical Trial Overview
76. Clinical trials of new drugs are divided into three phases under FDA regulations.
See 21 C.F.R. § 312.21. Phase 1 trials typically evaluate the “metabolism and pharmacologic
actions of the drug in humans, the side effects associated with increasing doses, and, if possible, .
. . gain early evidence on effectiveness.” 21 C.F.R. § 312.21(a)(1).
Phase 2 includes the controlled clinical studies conducted to evaluate the
effectiveness of the drug for a particular indication or indications in patients with
the disease or condition under study and to determine the common short-term side
effects and risks associated with the drug. Phase 2 studies are typically well
controlled, closely monitored, and conducted in a relatively small number of
patients, usually involving no more than several hundred subjects.
21 C.F.R. § 312.21(b). Next, Phase 3 trials are “performed after preliminary evidence suggesting
effectiveness of the drug has been obtained, and are intended to gather the additional information
about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the
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drug and to provide an adequate basis for physician labeling.” 21 C.F.R. § 312.21(c). Phase 3
trials “usually include from several hundred to several thousand subjects.” Id.
77. Phase 1 of the trial at issue concluded in the summer of 2020. It involved 195
United States participants aged eighteen to fifty-five. Several different doses were tested, and the
most successful, called “BNT162b2,” was advanced to Phase 2 and 3 testing. See Edward E.
Walsh et al., Safety & Immunogenicity of 2 RNA-Based COVID-19 Vaccine Candidates, New
England Journal of Medicine (Oct. 14, 2020).3
78. In Phase 2 and 3 of the trial, the vaccine at issue was administered as an
intramuscular injection. The clinical trial protocol requires that it be administered in two doses
separated by nineteen to twenty-three days. Ex. 7, Clinical Trial Protocol, at 88; Ex. 6, BNT162b2
Product Manual, at 45.
79. Pfizer expanded the trial to HIV-positive individuals, those with Hepatitis B and C,
and sixteen- and seventeen-year-olds in September of 2020, adding 14,000 new participants
worldwide. Pfizer again expanded the trial to young teenagers (aged twelve to fifteen) on October
12, 2020, adding approximately 4,400 more participants.
80. A total of 43,998 participants were enrolled in Phase 3 of the trial at issue, per
Pfizer’s reporting on clinicaltrials.gov.4 Approximately 1,500 of those were enrolled at Defendant
Ventavia’s facilities. Defendant Ventavia recruited study participants via advertising, contacting
local business and organizations, and features in local news media. Patients were paid for
participation in the study.
3
https://www.nejm.org/doi/10.1056/NEJMoa2027906?url_ver=Z39.88-
2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed.
4
https://clinicaltrials.gov/ct2/show/study/NCT04368728.
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81. Pfizer and BioNTech announced the completion of Phase 3 on November 18, 2020.
Ex. 8, Pfizer Press Release, at 2. Pfizer applied for EUA for BNT162b2 on November 20, 2020.
The FDA granted EUA on December 11, 2020.5
3. Clinical Trial Protocol
82. Pfizer has publicized its clinical trial protocol on the Internet, and it is attached
hereto as Exhibit 7. The protocol portions most relevant to this matter are summarized below.
a. Inclusion and Exclusion Criteria
83. The trial at issue is randomized, placebo-controlled, and observer-blinded. See Ex.
7, Clinical Trial Protocol, at 1. By the end of Phase 3, the trial included healthy individuals, aged
twelve to eighty-five, at risk of acquiring COVID-19, who are capable of informed consent and
willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and study
procedures. See Ex. 7, at 40–41. Individuals with certain pre-existing conditions or history are
excluded, including pregnant and breastfeeding women and people with a history of severe vaccine
reactions. See Ex. 7, at 41–43.
84. The study also excludes “[i]nvestigator site staff or Pfizer/BioNTech employees
directly involved in the conduct of the study, site staff otherwise supervised by the investigator,
and their respective family members.” Ex. 7, at 43.
85. Participants who have already begun the study must be withdrawn if they deviate
from the protocol, lose their eligibility, or take certain medications. See Ex. 7, at 50–53.
Participants who become pregnant after receiving the first dose of the vaccine, for example, must
withdraw from the study. See Ex. 7, at 65.
5
Press Release, FDA, 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.
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86. All participants’ eligibility screening evaluations must be reviewed “to confirm that
potential participants meet all eligibility criteria.” Ex. 7, at 55. Ventavia was required to “maintain
a screening log to record details of all participants screened and to confirm eligibility or record
reasons for screening failure, as applicable.” Id.
87. Each participant’s full date of birth must be collected in order to facilitate
evaluation of immune response and safety by age. Ex. 7, at 54.
b. Blinding
88. The study is observer-blinded. Ex. 7, at 1. The physical appearance of the vaccine
and placebo differ, so blinding the person administering the vaccine is not possible. See Ex. 7, at
36. The patient receiving the vaccine, study coordinator, and other site staff are blinded. See Ex.
7, at 36, 48–49.
89. At the test site level, the only people who should be unblinded are those
administering the injection. See Ex. 7, at 36, 48–49. Nobody involved in “evaluation of any study
participants” should be unblinded. Ex. 7, at 49.
c. Temperature Control
90. The investigator must confirm that all vaccine doses received have been transported
and stored under “appropriate temperature conditions[,]” and that “any discrepancies are reported
and resolved before use of the study intervention.” Ex. 7, at 47.
91. The vaccines must be stored in “a secure, environmentally controlled, and
monitored” area in accordance with the product manual, as described further infra. Id. Daily
maximum and minimum temperatures must be recorded for all storage locations and those records
must be made available upon request. See id.
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92. Any deviations from recommended temperature, called “temperature excursions,”
must be reported to Pfizer upon discovery, “along with any actions taken.” Ex. 7, at 47. The
vaccines subject to the excursion must be quarantined from others and not used unless Pfizer
subsequently provides permission. See id.
d. Informed Consent
93. As with all clinical drug trials, the participant must provide informed consent. The
protocol for the trial at issue requires obtaining signed and dated informed consent documentation
prior to performing any study-specific procedures, including administration of the vaccine. See
Ex. 7, at 54, 117.
e. Administration
94. Before administration of the vaccine, study participants receive a clinical
assessment “to establish a baseline.” Ex. 7, at 58. The participant’s medical history and
observations from any physical examination must be documented and submitted to Pfizer. See id.
95. Women of childbearing potential must undergo a pregnancy test before receiving
the vaccine or placebo. See Ex. 7, at 23, 65,
96. Only participants enrolled in the study may receive the vaccine, and only authorized
site staff may administer it. Ex. 7, at 47.
97. Study participants must receive the vaccine “under medical supervision.” Ex. 7, at
50. The date and time of injection must be recorded. Id.
98. Participants must receive their second injection nineteen to twenty-three days after
the first. See Ex. 7, at 23, 88.
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f. Safety and Monitoring
99. All adverse events in the first thirty minutes after injection must be documented in
an Adverse Event Case Report Form. See Ex. 7, at 58, 86, 89.
100. Participants use an electronic diary (“e-diary”) application to record any adverse
events and use of any antipyretic (fever-reducing) medication. See Ex. 7, at 58–59. E-diary data
is periodically transmitted directly to Pfizer and Icon. See Ex. 7, at 59.
101. After participants report any ongoing local reactions, systemic events, or use of
antipyretic medication, the investigator must obtain and document end dates for those events. See
Ex. 7, at 59–60.
102. Serious adverse events (“SAEs”) must be reported to Pfizer within twenty-four
hours. Ex. 7, at 66. Under no circumstances should they be reported later. Id. Any update to
SAE information must be reported to Pfizer within twenty-four hours of it becoming available. Id.
Any non-serious adverse events must be reported and documented on Case Report Forms
submitted to Pfizer. See id. Site investigators are responsible for pursuing and obtaining “adequate
information both to determine the outcome and to assess whether the event” is serious “or caused
the participant to discontinue the study intervention.” Ex. 7, at 65.
103. Follow-up on adverse events must continue until the event resolves or stabilizes at
a level acceptable to the investigator and concurred with by Pfizer. Id. Follow-up information
must include enough detail to allow for complete medical assessment and independent
determination of possible causality. Ex. 7, at 67.
104. If any participant is confirmed to have been injected while pregnant or
breastfeeding, Pfizer must be notified within twenty-four hours. See Ex. 7, at 67–68. The same
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applies to pregnancy in partners of clinical trial participants. Id. The investigator must conduct
follow-up on the pregnancy and its outcome and keep Pfizer updated. See Ex. 7, at 68–69.
g. Legal and Regulatory Compliance
105. The protocol emphasizes that investigators must notify Pfizer of SAEs “so that legal
obligations and ethical responsibilities towards the safety of participants and the safety of [the
vaccine] under clinical investigation are met.” Ex. 7, at 67. The protocol notes that Pfizer “has a
legal responsibility to notify” the government about the safety of the vaccine under investigation,
and “will comply with country-specific regulatory requirements relating to safety reporting to the
appropriate regulatory authority . . . and investigators.” Id.
106. The protocol also states that the study will be conducted in accordance with all
applicable laws and regulations, including privacy laws. Ex. 7, at 116.
107. Ventavia is responsible for oversight of the study at their sites and adherence to
FDA regulations found in Title 21 of the Code of Federal Regulations. See id.
h. Adherence to Protocol
108. Adherence to the trial protocol “is essential and required for study conduct.” Ex.
7, at 54. “Protocol waivers or exemptions are not allowed.” Id. Thus, as noted previously,
participants who deviate from the protocol must be excluded.
109. The protocol also requires that the clinical trial adhere to “ICH GCP”—Good
Clinical Practices established by the International Council for Harmonization. See Ex. 7, at 116,
138–39.
110. Any failure to provide a test or procedure required by the protocol must be
documented, alongside any corrective or preventive actions taken by the administrator, and
Pfizer’s safety team must be informed. See Ex. 7, at 55.
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111. Site investigators must inform Pfizer immediately if they know of any new
information which might influence the evaluation of the benefits and risks of the vaccine at issue.
Ex. 7, at 116. They must also immediately inform Pfizer of any serious breaches of the study
protocol or ICH GCP. Id.
112. Pfizer may close a study site early for any reason, including when the site
investigator fails to comply with the study protocol. See Ex. 7, at 121.
i. Accuracy of Data
113. Site investigators must maintain accurate source documentation supporting all
information entered into electronic Case Report Forms submitted to Pfizer. See Ex. 7, at 119–21.
If source documents differ from any information in the Case Report Form, the discrepancy must
be explained. Ex. 7, at 120.
114. Site investigators must verify that data entries are accurate and correct by signing
the Case Report Forms transmitted to Pfizer. Ex. 7, at 119.
115. Pfizer or Icon is responsible for data management of the study, “including quality
checking of the data.” Ex. 7, at 120.
4. BNT162b2 Product Manual
116. The product manual for BNT162b2—attached hereto as Exhibit 6—provides
specifics as to how the vaccine and placebo should be stored and administered. These specifics
supersede storage conditions set out in the clinical trial protocol, and provide additional guidance
for temperature excursions and use. See Ex. 7, Clinical Trial Protocol, at 47–48, 52, 80, 86, 88.
Thus, noncompliance with the product manual is equivalent to noncompliance with BNT162b2’s
clinical trial protocol.
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a. Additional Blinding Precautions
117. The patient, study coordinator, and other test site staff are blinded, as previously
noted. The vaccinator is not. “Blinded personnel should not have access to the container IDs” for
the vaccine. Ex. 6, Product Manual, at 23. “Only the site staff who will be dispensing, preparing,
and administering the [vaccine] are unblinded and can have this access.” Id.
118. Occluding labels are applied to the syringe barrel in order to mask its contents and
preserve blinding. See Ex. 6, at 49–50. Patients are also instructed to look away during injection.
See Ex. 6, at 50.
119. Each prepared BNT162b2 syringe expires six hours after preparation. Ex. 6, at 49.
To preserve the blind, both the vaccine and placebo are given the same expiration date and time.
Id.
120. Sites must have a process in place for maintaining the study blind, including
ensuring that vials, dilution material, and dosing syringes “are shielded from the view of
BLINDED study staff and the participant during dose preparation, dispensing, transportation,
administration, and disposal.” Ex. 6, at 49. The site should “ensure that the study blind was
maintained and that the [BNT162b2] cartons, preparation records, syringes, and disposal of used
supplies were carefully handled prior to and after administration.” Id. The site must document for
each participant whether the blind was maintained. See Ex. 6, at 50.
121. Pfizer must be notified of any potential unblinding, and further enrollment and
injection must stop immediately:
if the study drug is not stored, handled, or administered according to the protocol
and/or relevant site documentation to adequately maintain the blind. The site must
provide details of the incident or any protocol deviations and[] assist in resolving
the issue and/or determining corrective actions to take.
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If the blind is broken or potentially broken, unblinded staff must contact [Pfizer]
immediately. Do not administer or dispense the study drug to any participant and
do not randomize a new participant until the Sponsor provides further instructions.
Ex. 6, at 43.
b. Temperature Excursions
122. BNT162b2 must be protected from light and stored at -112°F to -76°F in its original
packaging prior to use in dose preparation. See Ex. 6, at 36, 40.
123. BNT162b2 is shipped in a specialized container with dry ice (solid carbon dioxide).
Ex. 6, at 36. The shipping containers used in the clinical trial included a monitoring device that
triggered an alarm if the acceptable temperature range for the product was exceeded. See Ex. 6, at
36, 38.
124. If any deviation in temperature for BNT162b2 shipments outside of the accepted
range occurs, the product must be segregated and the excursion must be reported to Pfizer. See
id.; Ex. 7, Clinical Trial Protocol, at 47. Pfizer then notifies the site if the product is acceptable
for use despite the excursion. See Ex. 6, at 38.
125. The same process must be followed if there is any lapse in temperature monitoring
or even when the site is not sure if there has been a temperature excursion. See Ex. 6, at 40.
c. Dose Preparation
126. BNT162b2 is shipped as a frozen concentrate, which is thawed for approximately
30 minutes and diluted with sodium chloride (saline) solution before injection. Ex. 6, at 47. “Only
clinical site personnel who are appropriately trained on the procedures” in the product manual may
prepare and administer BNT162b2. Ex. 6, at 46.
127. The doses must be allowed to reach room temperature before administration. Ex.
6, at 48. Preparation time is standardized at thirty minutes or more in order to avoid unblinding,
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since the placebo has no thaw time. See Ex. 6, at 47–49, 53, 56, 60, 72, 76; Ex. 9, E-mail Chain
with Downs and Others (Sept. 18, 2020), at 2.
d. Injection
128. Participants are injected using a 1” or 1.5” needle, depending on their body weight.
Ex. 6, at 51. A 5/8” needle may also be used for participants weighing less than 130 pounds if the
skin is stretched tightly. Id. The 1” needle size is appropriate for all participants except males
over 260 pounds and females over 200 pounds, for whom a 1.5” needle is required. See id.
129. Only “an appropriately qualified and experienced member of the study staff” may
prepare and administer the vaccine or placebo. Ex. 6, at 44, 72, 75, 78. The product manual
specifies that this must be a “nurse, physician’s assistant, nurse practitioner, pharmacy
assistant/technician, or pharmacist[,] as allowed by local, state, and institutional guidance.” Id.
130. The vaccine is injected into the deltoid muscle of the participant’s non-dominant
arm. Ex. 6, at 44.
131. Any error in dispensing the vaccine that may cause or lead to patient harm while in
the site’s control must be reported to Pfizer and Icon immediately. Ex. 6, at 62.
e. Monitoring
132. “Blinded site staff must observe” clinical trial participants after injection “for at
least 30 minutes” to monitor “for any acute reactions.” Ex. 6, at 44; see also Ex. 6, at 61. Reactions
must be recorded in source documents, on an adverse event reporting form, and also as an SAE if
necessary. Ex. 6, at 44.
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D. Contract at Issue
1. Background
133. On July 21 2020, the United States DoD entered into the contract at issue with
Defendant Pfizer, through Advanced Technology International (“ATI”). See Ex. 10, Pfizer-DoD
Contract, at 1.
134. DoD likely used ATI as its intermediary in order to simplify the contracting process
and avoid possible delay resulting from typical procurement processes. Despite the use of an
intermediary, the United States has clearly stated that the contract is between itself and Pfizer. See
Ex. 10, Pfizer-DoD Contract, at 1, 2; Press Release, HHS, U.S. Government Engages Pfizer to
Produce Millions of Doses of COVID-19 Vaccine (July 22, 2020).6
135. Under the contract, DoD purchased 100 million doses of the vaccine at issue, with
the option to purchase up to 500 million more doses later. See Ex. 10, at 11–12, 17. DoD
contracted to pay Pfizer $1.95 billion for the vaccines ($19.50 per dose) after FDA approval or
Emergency Use Authorization (“EUA”). See Ex. 10, at 1, 17.
136. The clinical trial at issue, which was privately-funded, aimed to secure FDA
approval or EUA of the vaccine by the end of 2020, resulting in DoD’s purchase of the vaccine
and payment to Pfizer under the contract. See Ex. 10, at 5, 6.
137. Pfizer delegated some management of the clinical trial at issue to Defendants Icon
and Ventavia, as previously explained.
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. See Ex. 10, at 17.
6
https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-
vaccine.html.
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139. In late December of 2020, DoD exercised a contractual option to purchase 100
million more doses of the vaccine for $1.95 billion. Thus, the contract’s total value is now $3.9
billion.
2. FAR Compliance
140. In performing under the contract at issue, Pfizer must comply with Federal
Acquisition Regulations (“FAR”), including but not limited to the provisions discussed below. See
42 C.F.R. §§ 3.1004(a), 52-203.13; Ex. 4, Form FDA-1571, at 2; Ex. 7, Clinical Trial Protocol, at
116.
141. FAR 52.203-13 contains the Contractor Code of Business Ethics and Conduct. In
relevant part, that regulation requires Pfizer to maintain a code of ethics and conduct, exercise due
diligence to prevent criminal conduct, and disclose any credible evidence that a subcontractor
(including Icon and Ventavia) has committed a False Claims Act violation. 48 C.F.R. § 52.203-
13(b). This regulation also requires Pfizer to maintain an “internal control system” with
procedures in place to detect fraud and improper conduct “in connection with Government
contracts.” 48 C.F.R. § 52-203.13(c)(2). Pfizer must include the Contractor Code of Business
Ethics and Conduct in any subcontract with a performance period over 120 days. 48 C.F.R. § 52-
203(13)(d)(1).
142. FAR 42.202(e)(2) requires Pfizer to manage all of its subcontracts. See 48 C.F.R.
§ 42-202(e)(2). Pfizer was therefore required to monitor Ventavia and Icon’s performance and
ensure that they complied with the clinical trial protocol. Id.
3. FAR Certification
143. Federal Acquisition Regulation 52.232-32 requires Pfizer to certify the following,
in relevant part, in any request for payment under the contract:
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I certify to the best of my knowledge and belief that-
(1) This request for performance-based payment is true and correct; this request
(and attachments) has been prepared from the books and records of the Contractor,
in accordance with the contract and the instructions of the Contracting Officer[.]
48 C.F.R. § 52.232-32(m).
VIII. DEFENDANTS’ FRAUD ON THE GOVERNMENT
144. Defendants’ conduct in the clinical trial at issue violates its own stated protocols,
FDA regulations, and FAR, as described further below. Defendants fraudulently misrepresented
their regulatory and protocol compliance to the United States and submitted false data in support
of the clinical trial at issue.
A. Violation of Clinical Trial Protocol
145. Relator observed noncompliance with virtually every aforementioned provision of
the clinical trial protocol at issue, as explained further below.
146. Every violation of the clinical trial protocol is a violation of the False Claims Act.
Defendants represented to the United States in FDA forms 1571 and 1572 that they would abide
by the protocol. See Ex. 4, Form FDA-1571; Ex. 5, Form FDA-1572. Defendants’ regulatory
noncompliance rendered Pfizer’s later claims for payment fraudulent.
147. Additionally, the clinical trial protocol is a false record material to Pfizer’s claims
for payment. Pfizer submitted the protocol to the United States alongside its IND. Defendants’
protocol noncompliance rendered the protocol false, and DoD would not have paid for the vaccines
if it had known of Defendants’ widespread noncompliance with the submitted protocol.
1. Inclusion and Exclusion Criteria
148. Ventavia enrolled and injected ineligible clinical trial participants.
149. Pregnant individuals are ineligible, and the trial protocol contains multiple layers
of safeguards to prevent administration of the vaccine or placebo to them. See Ex. 7, Clinical Trial
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Protocol, at 42, 44, 52, 65, 73, 86, 88, 132–35. Women of childbearing potential (“WOCBPs”)
and their partners must provide information about and use certain methods of contraception. See
Ex. 7, at 44, 73, 86, 88, 132–35. WOCBPs also undergo a pregnancy test at every vaccination
appointment during the trial, as previously noted.
150. Due to Ventavia’s carelessness and rush to enroll and inject as many patients as
possible, however, pregnant women appear to have been enrolled in the clinical trial and injected
with the vaccine or placebo. See Ex. 12, E-mail Chain with Raney (Sept. 17, 2020), at 3, 5–6
(describing injection of pregnant patient after a positive pregnancy test). Ventavia did not report
all clinical trial participants’ pregnancies to Pfizer and Icon as required. See Ex. 7, at 67–68, 128
(required reporting protocol).
151. Women who have undergone a tubal ligation may still become pregnant.
The clinical trial protocol does not list tubal ligation as an accepted contraception method. See Ex.
7, at 134. As a result, Ventavia was required to ensure that these women provided other
contraception information and that pregnancy tests were administered before injection with
BNT162b2 or placebo. Ventavia instead treated these women as non-WOCBPs, violating the
clinical trial protocol. See Ex. 11, Ventavia’s Quality Control Findings, at 3 (Subject 1018, seen
at Keller site, had tubal ligation, but pregnancy test was not given). Ventavia’s violations in this
regard would be obvious from the source documents. Pfizer and Icon ignored these red flags and
kept the ineligible participants’ data in the clinical trial.
152. Ventavia’s recklessness also resulted in other ineligible participants being enrolled
and injected. The errors were not timely “caught” or corrected, due to Ventavia’s recklessness and
long-delayed “quality control” of source documents.
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153. For example, Subject 11281302 was enrolled and injected before routine laboratory
work and a nasal swab COVID-19 test. The subject also did not give informed consent until after
injection. If this subject was COVID-19 positive, that would have rendered him or her ineligible.
Furthermore, the failure to obtain informed consent is itself a protocol, regulatory, and ethical
violation. When “quality checking” this subject’s documents, furthermore, Ventavia edited a
question about why injection preceded informed consent, transforming it into a comment that the
informed consent time was incorrect:
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Ventavia subsequently would have “corrected” this patient’s records to hide the informed consent
and ineligibility violations, creating false source documents.
154. Relator also observed that Ventavia employees and their family members were
enrolled in the clinical trial, in direct breach of the protocol, creating a serious conflict of interest.
2. Blinding
155. The clinical trial at issue is observer-blinded. At each study site, only those
administering the vaccine and placebo are unblinded. See Ex. 7, at 47–49. Thus, the only
unblinded people at Ventavia’s study sites should have been those vaccinating patients: Kandy
Downs, Nadia Martinez, Jailyn Reyes, and Cordy Henslin. However, Ventavia’s recklessness in
product and document handling led to more people becoming unblinded—including Relator,
Fisher, and Fort Worth Site Operations Manager Jennifer “Jen” Vasilio. More people were likely
unblinded as well, since the conduct described below had the potential to unblind patients and
anyone working at Ventavia’s Fort Worth and Keller locations.
156. On September 16, 2020 Relator photographed BNT162b2 vaccine boxes left out in
the open at Ventavia’s Fort Worth location, and later sent her photos to management. These boxes
were marked as such and bore numbers that allow determination of whether a patient received a
placebo or the Pfizer-BioNTech vaccine. This type of unblinding incident had occurred before at
least once. See Ex. 13, Unblinding E-mail Chain (Sept. 22, 2020), at 1 (describing a similar
incident witnessed one month prior by Downs). Neither unblinding was ever reported to Pfizer.
Instead, Fisher directed Relator and others to discipline the responsible employees. Id.
157. On or around September 14, 2020, Ventavia discovered that randomization
confirmation pages had improperly been placed in every patient’s chart. These pages unblind the
reader by revealing whether or not the patient received a placebo, and had been in place since the
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beginning of Ventavia’s involvement in the Pfizer-BioNTech trial. Approximately 1,200 patients’
charts were affected, compromising the integrity of the trial. Ventavia subsequently removed or
“lined through” (crossed out) this information, but it had been visible and accessible to all
employees and patients for over two months. Ventavia did not report this issue to Pfizer or Icon,
instead placing Notes to File (“NTFs”) in patients’ charts, dated September 17, 2020 and stating:
This Note to File serves as notification that confirmation printouts of research
participant drug assignments will not be placed within participant charts for study
C4591001. Inclusion of the drug assignment confirmation will disclose drug
dosage information contraindicated for study blinding. It is for this purpose that
the confirmation of drug assignment is located in Complion within the unblinded
binder. This note to file addresses IMPALA drug assignment confirmation
requested in study source document versions 1 through 5.
An update [to] the source document removing this requirement has been created
in follow-up to this Note to File.
Ex. 14, NTF on Randomization, at 1. The NTFs are not viewable by Pfizer or Icon until the end
of the clinical trial. The NTF on randomization, furthermore, does not show that patients and staff
could have been unblinded; it simply states that randomization documents should not be in
patients’ charts. See id. However, Pfizer was alerted to the issue via a “red flag” e-mail chain
from September 14–18, 2020, sent to Dr. Arturo Alfaro of Pfizer. Downs asked Alfaro to confirm
that randomization forms should not be given to blinded staff, and Alfaro concurred. See Ex. 15,
E-mail Chain with Downs and Alfaro, at 1–2. Pfizer should have realized that Downs’ inquiry
could indicate that the unblinding had already occurred. To Relator’s knowledge, Pfizer never
followed up on the issue or removed affected patients’ data from the clinical trial, resulting in fraud
on the United States DoD.
158. Ventavia’s unblinded vaccinators also carelessly forwarded and shared
communications marked “UNBLINDING”—intended only for unblinded staff—to staff who
should have been blinded. For example, on September 15, 2020, Recruitment Specialist Cordy
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Henslin forwarded such an e-mail to Relator. Ex. 16, E-mail Chain with Henslin, at 1. The e-mail
was originally sent by Icon to Henslin, and contained subject numbers, placebo dosing
information, and other data that unblinded Relator. See Ex. 16, at 1–4.
159. During her employment, Relator observed that the Pfizer-BioNTech vaccine
containers were stored in a manner that could unblind Ventavia staff and patients. Specifically,
the vaccines for all vaccine trials at Ventavia were stored together, and the vaccines for this trial
were labeled with each patient’s subject identification number after randomization. The vaccines
are often left outside of cabinets while thawing, exposing that unblinding information to all in the
vicinity. The vaccine preparation area is accessible by any staff member and even visible by
patients—especially when patients were placed in hallways for “observation” after injection. To
provide an illustration, if an employee was blinded for the trial at issue, but unblinded on another
trial, she would be able to see patients’ IDs and drug assignment for the trial at issue every time
she went to the vaccine preparation area—becoming unblinded.
160. When Relator joined Ventavia, she was given lists of action items that predated her
employment. Based on that documentation, inadvertent unblinding was also an issue at Ventavia’s
Keller location.
161. The above conduct constituted reportable violations of the clinical trial protocol
which compromised the integrity of the entire study and should have been reported to Pfizer and
Icon, per the protocol. See Ex. 7, at 54–55, 116. However, when Relator reported unblinding
concerns to Ventavia management, for example, she was instructed to “write up” Fort Worth’s
vaccinators for discipline. Management appeared more concerned with punishing employees than
investigating the extent of the unblinding. Unblinding incidents were never reported to Pfizer
during Relator’s employment, and were documented only in NTFs.
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3. Temperature Control
162. Ventavia, in violation of temperature control requirements in the clinical trial
protocol and product manual, did not report all temperature excursions to Pfizer, and did not
always properly segregate vaccines affected by excursions.
163. For example, around September 11, 2020, a freezer at Ventavia’s Keller location
was unplugged and moved, resulting in a temperature excursion. The excursion was reported to
Pfizer late, in violation of the protocol’s requirement that excursions be reported as soon as
discovered. The Fort Worth site also had unreported temperature excursions.
4. Informed Consent
164. Ventavia performed screening and injected clinical trial patients prior to obtaining
informed consent, in direct violation of the clinical trial protocol. See Ex. 7, at 54, 117.
165. For example, on July 30, 2020, Ventavia recorded identical informed consent and
vital sign collection times for Subject 1001 at Keller—an impossibility. Ex. 11, Ventavia’s Quality
Control Findings, at 1 (“[informed consent form] time same as [vital signs] Rest”). Relator
observed that this often was due to vital signs being taken during or before the informed consent
process. She also observed that the issue was often corrected during “quality control” by falsifying
the time of vital signs to several minutes after informed consent. This is likely what was done to
“correct” Subject 11281001’s source documents. Similar issues were observed for the following
clinical trial participants, and were likely corrected via falsification:
Subject Number Site Visit Type Date of Visit Reflected in
1004 Keller Eligibility Screening July 30, 2020 Ex. 11, at 1
1007 Keller Eligibility Screening July 30, 2020 Ex. 11, at 2
1010 Keller Unspecified July 30, 2020 Ex. 11, at 2
1011 Keller Unspecified July 30, 2020 Ex. 11, at 2
1013 Keller Unspecified July 30, 2020 Ex. 11, at 2
1083 Keller Unspecified Aug. 11, 2020 Ex. 11, at 5
1087 Keller Unspecified Aug. 11, 2020 Ex. 11, at 5
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Subject Number Site Visit Type Date of Visit Reflected in
1088 Keller Unspecified Aug. 12, 2020 Ex. 11, at 5
1090 Keller Unspecified Aug. 12, 2020 Ex. 11, at 5
11281007 Fort Worth First Injection July 31, 2020 Ex. 11, at 12
11281010 Fort Worth First Injection July 31, 2020 Ex. 11, at 13
11281011 Fort Worth First Injection July 31, 2020 Ex. 11, at 13
11281012 Fort Worth First Injection July 31, 2020 Ex. 11, at 14
166. This issue was also observed as a recurring problem by Fisher on September 21,
2020. See Ex. 17, Fisher’s List of Deficiencies, at 2–3 (describing ongoing informed consent
timing errors and need for correction).
167. To give another example, on August 5, 2020, Subject 11281035’s progress notes
were written prior to execution of informed consent. See Ex. 11, Ventavia’s Quality Control
Findings, at 3.
168. A Ventavia-internal quality assurance checklist circulated by Livingston on
September 22, 2020 documenting common documentation errors at Ventavia noted that the
incorrect version of the informed consent form was often used, informed consent forms sometimes
had “obvious mismatch[es]” in signatures (indicating possible forgery of patient signatures), and
other problems. Ex. 18, Common Quality Assurance Findings Checklist, at 1.
169. Ventavia likely falsified informed consent times in order to hide these protocol
deviations from Pfizer and Icon. However, Pfizer and Icon had access to the original source
documents in many cases, imparting constructive knowledge of informed consent time
discrepancies. See Ex. 19, E-mail Chain with Icon (Sept. 21, 2020), at 1, 3, 4–5 (noting informed
consent date errors). Pfizer also received e-mails from Ventavia indicating past informed consent
protocol violations. See Ex. 20, Informed Consent E-mail Chain with Alfaro and Others (Sept. 24,
2020). Had Pfizer reviewed data as required, it would have noticed this issue and removed these
patients’ data from the clinical trial, but it did not.
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170. Ventavia never reported its informed consent violations to the IRB overseeing the
clinical trial.
5. Dose Preparation
171. Ventavia routinely rushed preparation of BNT162b2 frozen concentrate, in
violation of the clinical trial protocol and resulting in potential unblinding of clinical trial
participants. Livingston directed employees to hold the frozen concentrate in their hand to thaw it
faster than the mandated thirty minutes. See Ex. 6, Product Manual, at 47, 53, 56, 72, 76; Ex. 9,
E-mail Chain with Downs and Others, at 1–2, 4; Ex. 21, Daily Status Updates E-mail Chain, at
51–53. Ventavia did this to maximize the number of patients injected per day and their per-patient
payments from Pfizer.
172. Ventavia was also using an outdated product manual that set a thaw time of twenty,
rather than thirty minutes. See Ex. 9, at 4. Pfizer notified Ventavia of this in August of 2020, and
was placed on notice that Ventavia was likely deviating from thaw time protocols. See id. The
issue persisted, however. On September 21, 2020, Fisher listed injection wait times of less than
thirty minutes as a consistent issue, finally suggesting protocol deviation reporting and resolution
with an NTF. See Ex. 17, Fisher’s List of Deficiencies, at 2. However, to Relator’s knowledge,
Pfizer never removed the affected patients’ data from the clinical trial.
6. Administration
173. Ventavia, in violation of the clinical trial protocol, used improperly-trained
vaccinators. Cordelia “Cordy” Henslin (“Henslin”), a medical assistant, was qualified to
vaccinate, but was trained over the telephone instead of in-person. And, that training did not occur
until after Henslin had already started giving BNT162b2 to patients in the Pfizer-BioNTech trial.
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174. Issues with Henslin were discussed via e-mail. Ray noted on August 28 that she
was uncomfortable with Henslin being “the only unblinded vaccinator for this trial” at her site,
and asked for a more experienced person to give training. Ex. 21, Daily Status Updates E-mail
Chain, at 29. Raney replied: “I actually feel like this was brought up a few weeks ago…that
[Henslin] had no training and has very little oversight [because] she is the unblinded.” Ex. 21, at
28. Raney expressed concern that “something bad is going to happen with” Henslin unless she
was trained. Ex. 21, at 29. On August 31, 2020, Downs acknowledged via e-mail that Henslin
had finally been trained but over the telephone, and only later “rechecked when onsite.” Ex. 21,
at 27.
175. Additionally, other vaccinators were unqualified to administer BNT162b2. Nadia
Martinez, an office assistant at the Fort Worth site, who had no medical certifications or
background, acted as an unblinded vaccinator in the Pfizer-BioNTech trial. See Ex. 22, E-mail
Chain with Fisher, Raney, and Others (Sept. 9, 2020), at 2. Ventavia was seeing so many patients
that the qualified vaccinator at that site, Jailyn Reyes, was unable to perform all vaccinations. See
id.; Ex. 23, E-mail Chain with Livingston, Vasilio, and Others, at 2 (“Nadia is now doing all the
vaccines for the COVID trial, to eliminate this from Jailyn’s plate, occasionally if Nadia is behind
or not in office, then Jailyn will jump in to vaccinate”).
176. Many clinical trial participants were given their second injection outside of the
protocol-mandated nineteen to twenty-three day window. Relator and others reported this to
Ventavia staff multiple times. See, e.g., Ex. 1, Text Messages with Ray and Others (Sept. 17,
2020), at 1 (noting injection “OOW”, meaning out of window); Ex. 2, E-mail Chain with Ray and
Others (Sept. 23, 2020), at 1 (noting “visits that are out of window”); Ex. 18, Common Quality
Assurance Findings Checklist, at 1. Ventavia never reported this violation to Pfizer or Icon, but it
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would have been obvious from the source documents. However, Pfizer and Icon, to Relator’s
knowledge, never removed these patients from the clinical trial data.
177. Multiple clinical trial participants were injected with the wrong needle size for their
body weight and sex, in violation of the clinical trial protocol. For example, on August 7, 2020,
Subject 11281072 was injected with the wrong size needle at Ventavia’s Fort Worth site. See Ex.
11, Ventavia’s Quality Control Findings, at 24. The same issue recurred for Subjects 11281054,
11281050, 11281047, 11281040, 11281039 at the Fort Worth site. See Ex. 11, at 21–24. Ventavia
also did not record needle size for multiple participants, meaning that more patients could also
have been injected with the wrong needle size. See Ex. 11, at 17, 19, 20, 24. If this issue was not
concealed via needle size falsification by Ventavia, then Pfizer and Icon had constructive notice
of it via the source documents, and violated regulations by not removing these patients from the
clinical trial data.
178. Ventavia also improperly diluted the concentrated BNT162b2 vaccine and did not
document that failure. At least four times, Ventavia employees used too much sodium chloride
solution for dilution (1.7 mL versus 1.2 mL). Defendant Icon noticed the issue and informed
Ventavia. Ventavia falsely told Icon that the discrepancy was due to a transcription error. See Ex.
16, E-mail Chain with Henslin (Sept. 15, 2020), at 2.
7. Safety and Patient Monitoring
179. In violation of the clinical trial protocol, clinical trial participants were not
monitored under medical supervision for thirty minutes after injection. See Ex. 6, Product Manual,
at 44, 61; Ex. 7, Clinical Trial Protocol, at 50. Ventavia’s Fort Worth site, for example, had only
five examination rooms. To see as many patients as possible per day, patients were instructed to
wait in a hallway for thirty minutes after injection. A Ventavia receptionist or non-medically-
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qualified employee periodically “checked on” the patients and asked if they were “OK.” This does
not rise to the level of thirty minutes of “medical supervision” required by the protocol. Ex. 7,
Clinical Trial Protocol, at 50; see also Ex. 6, at 44. Furthermore, the period of supervision was
frequently less than thirty minutes. See Ex. 1, Text Messages with Ray and Others (Sept. 17,
2020), at 1.
180. Ventavia’s lack of patient monitoring was reported to management by Relator and
by multiple employees, and acknowledged as a recurring issue. See, e.g., Ex. 1, Text Messages
with Ray and Others (Sept. 17, 2020), at 1; Ex. 24, Mercedes Livingston’s List of Common Errors
(Sept. 22, 2020), at 2. Pfizer was put on notice of Ventavia’s patient monitoring violations by
Relator in an anonymous post-termination telephone call to Dr. Arturo Alfaro.
181. In a September 22, 2020 list of common errors in documentation and protocol
compliance, Director of Operations Mercedes Livingston acknowledged that “Patients[’] location
during 30 minute waiting period” after injection was an issue, and that she would train employees
accordingly. Ex. 24, at 2. Livingston instructed employees as follows:
• Be in the waiting area where the receptionist can see the patients
• If in the hallway, a staff member needs to be in the hallway with a work station
• Patients need to be brought back into a room for 30-minute post observation
period.
Ex. 24, at 2 (emphasis added). Relator observed that Ventavia’s monitoring practices did not
change despite Livingston’s stated plan, and that non-medical personnel were still performing
“observation.”
182. Ventavia management perceived its patient monitoring practices as sufficient and
questioned whether patient safety was really at risk. As Jones and Fisher told Relator at a
September 24, 2020 meeting:
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BROOK JACKSON: Okay, if we’re gonna talk about just the safety, the safety
of the patient component, they know that they don’t have the rooms to manage
the number of patients [for] their recruitment goals that they’re putting for these
sites.
MARNIE [FISHER]: That’s –
WILLIAM JONES: So what would be your recommendation? As the expert?
BROOK JACKSON: As the expert – you just –
MARNIE [FISHER]: Hold that thought. And, what are you seeing that has led to
that’s a safety issue – . . . That you’ve seen, that’s gonna be a [FDA] warning
letter? That’s what I mean. That detail. So we can target –
BROOK JACKSON: But nobody would ever know if we were putting patients
in the hallway and they weren’t being monitored. But –
MARNIE: But they are, they are being checked on. See that’s what I mean, like,
they are.
BROOK JACKSON: Marnie, no, they’re not.
MARNIE: They are! Because I see them out there. When I’m coming and
going, I’m seeing people out there all the time. They are but, now, do we have it
documented? That’s where I would say, “Okay…” That’s what I mean by go find
– okay, that’s a concern. Are we documenting it? Is it clear? So we can speak to
that.
Ex. 3, Transcript of September 24, 2020 Meeting Recording, at 27–28 (emphasis added).
183. Ventavia also failed to report all adverse events and Serious Adverse Events
(“SAEs”) to Pfizer and Icon in the clinical trial at issue.
184. On September 17, for example, Raney e-mailed Relator, Ray, Downs, Fisher, and
Livingston about issues with not reporting SAEs to Pfizer and Icon. See Ex. 12, E-mail Chain
with Raney, at 1–2. Ventavia was actually paid by Pfizer per SAE reported, making the failure all
the more puzzling. See Ex. 12, at 1.
185. In a September 21, 2020 e-mail to Livingston, Downs, Relator, and Jones
documenting ongoing issues, Fisher noted that adverse events “are not being reported correctly or
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at all[.]” Ex. 17, Fisher’s List of Deficiencies, at 1 (emphasis added). Fisher claimed that the
problem was due to conflicting information from Pfizer, but emphasized that Ventavia “should
follow the protocol as to how we read it and record any [adverse events] ASAP[.]” Ex. 17, at 1.
186. Pfizer and Icon had constructive notice of this issue because they had access to
clinical trial participants’ “electronic diary” entries, which recorded any symptoms experienced
after vaccination. Pfizer and Icon could have seen that Ventavia was not reporting all of these
diary entries as adverse events, as they were required to.
8. Accuracy and Completeness of Data
187. Ventavia maintained careless and sloppy documentation practices during the
Pfizer-BioNTech trial, violating the clinical trial protocol’s requirement that sites maintain
accurate source documents supporting all information submitted to Pfizer, and verify the accuracy
of all data entry. See Ex. 7, Clinical Trial Protocol, at 119–21. Ventavia even falsified some
patient data to cover protocol violations or missing data. Pfizer and Icon, despite obvious warning
signs of documentation failures in the source documents and its communications with Ventavia,
turned a blind eye to the fraud and, to Relator’s knowledge, did not remove affected patients’ data
from the clinical trial. By doing so, Pfizer and Icon violated their responsibility to quality check
all study data. See Ex. 7, Clinical Trial Protocol, at 120.
188. Ventavia’s over-enrollment of patients and rush to see as many as possible per week
took its toll on documentation. Data was often missing, and as previously mentioned, ineligible
patients were sometimes enrolled and injected. See, e.g., Ex. 2, E-mail Chain with Ray and Others
(Sept. 23, 2020), at 1 (reporting “missing charts” to Ventavia management).
189. Ventavia’s most egregious data and documentation failure relates to blood samples.
Patients’ blood is used to establish a baseline prior to injection with the vaccine or placebo. Any
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failure in timely processing or recording data from the first sample affects the baseline, which
could hide subsequent changes (and possible side effects) of the vaccine that could be slow to
develop. For example, white blood cell counts are a key metric and a defective baseline would
affect future readings. Furthermore, blood is used to measure immune response, in other words,
whether the vaccine actually works against COVID-19. Any errors in blood draw data or
processing go to the heart of the clinical trial—effectiveness of BNT162b2.
190. An example blood draw log from Ventavia’s Fort Worth location is attached hereto
as Exhibit 25. The document shows egregious data falsification and blood processing failures that
call into question the validity of all Ventavia patients’ data for the clinical trial. The document
reveals:
• The time that plasma samples were frozen was altered to hide delayed freezing. See
Ex. 25, Blood Draw Data, at 1. Freeze times are completely missing for some subjects.
See Ex. 25, at 5, 10, 18.
• The time of centrifuge insertion was altered to disguise noncompliance with required
clotting times (at least thirty minutes), required centrifuge times (at least fifteen
minutes), or processing delays. See Ex. 25, at 4, 7, 18.
• One patient’s blood did not clot, but a clot time was recorded anyway. See Ex. 25, at
4.
• No clot time or centrifuge insertion time was recorded for some patients. See Ex. 25,
at 7, 8, 18.
• Blood draw times are missing for some patients. See Ex. 25, at 15, 18, 19, 20.
• A clot time of 309 minutes is listed for Subject 11281013 at a post-injection monitoring
visit (visit 3). Ex. 25, at 1. Per Relator, the responsible employee left the lab and the
blood sample sat unattended, resulting in a very long clot time being recorded. The
patient should have been brought back to Ventavia for a re-draw, but that was never
done.
• Clot times of exactly thirty minutes are recorded for “strings” of over twenty patients
in a row—a strong indicator of falsified data. See Ex. 25, at 13–18, 24–28.
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191. The above violations are so obvious from the source documents that Pfizer and Icon
had constructive notice of Ventavia’s fraud. Icon also directly questioned missing blood collection
and processing times on September 21, 2020 in an e-mail to Fisher, Downs, Relator, and others.
See Ex. 19, E-mail Chain with Icon, at 1. Yet, to Relator’s knowledge, Pfizer and Icon never
removed affected patients from the clinical trial data.
192. Ventavia “quality checked” patients’ source documents after seeing each patient,
to make sure information was consistent with protocol, was not omitted, and matched up with
electronically-entered information. However, due to Ventavia’s push to maximize enrollment and
consequent revenue, “quality control” quickly fell behind its scheduled twenty-four hour window.
193. Ventavia eventually brought in employees’ friends and family members on
weekends to help “catch up” on quality control. These temporary employees were not listed on
delegation logs. Furthermore, some of the temporary employees were also clinical trial
participants—a serious conflict of interest.
194. Relator observed that quality control personnel were not fixing deficiencies in
documentation. She personally observed employees change data during “quality checking.” For
example, in late September of 2020, she observed employee Thea Sonnier (“Sonnier”) change
blood pressure readings in source documents, apparently fabricating new numbers. Sonnier was
one of the lead employees for “quality checking” and her practices would have been followed by
other employees at Ventavia.
195. Ventavia management was well aware of serious documentation issues—including
falsification of data—as far back as August 13, 2020. On that day, Fisher sent a company-wide e-
mail emphasizing the importance of filling out source documents “real-time.” Ex. 26, Source
Documentation E-mail Chain, at 1. Fisher noted that if data was completed after-the-fact:
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the time has passed so data or assessments have been forgotten, source may already
have been scanned in, signatures were missed[,] and now the investigator is not
available to sign. This results in deviations, queries, and overall will jeopardize
the integrity of the data and ultimately our reputation and future access to studies
and thus revenue coming in.
Ex. 26, at 2 (emphasis added). Nevertheless, falsification of data and incomplete documentation
persisted at Ventavia, and was never completely remedied. One month later, Fisher forwarded her
August 13 e-mail to Downs and Relator, noting that sites were still falling behind on
documentation. See Ex. 26, at 1.
196. Ventavia also failed to document improper dilution of the frozen BNT162b2
vaccine concentrate. Defendant Icon noticed the issue and informed Ventavia. Ventavia falsely
told Icon that the discrepancy was due to a transcription error. See Ex. 16, E-mail Chain with
Henslin (Sept. 15, 2020), at 2.
197. For months, Ventavia sites did not properly track when clinical trial participants
developed symptoms of COVID-19. Ventavia created a symptom log in August, but no sites used
it until Downs circulated the log on September 24, 2020. See Ex. 27, Symptom Log E-mail Chain
and Attachment (Sept. 24, 2020), at 1. The issue was documented in an NTF but Pfizer and Icon
were not notified. Nevertheless, Pfizer had constructive knowledge of this failure via the NTF,
and should have excluded affected patients from its trial data.
9. Adherence to Protocol
198. Defendants were required to adhere to Pfizer’s clinical trial protocol, but did not.
In addition to the protocol violations listed supra, Defendants also violated the clinical trial
protocol in the following ways.
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199. Ventavia did not consistently use up-to-date versions of the clinical trial protocol
or BNT162b2 product manual as they were required to. See Ex. 9, E-mail Chain with Downs and
Others, at 4; Ex. 17, Marnie Fisher’s List of Deficiencies (Sept. 21, 2020), at 1.
200. Clinical trial participants were, per the protocol, to be examined/enrolled one at a
time. Ventavia, however, cancelled single patients’ appointments in favor of married couples or
groups of friends who sought to participate in the trial. See Ex. 28, List of Action Items, at 14. In
Ventavia’s view, groups could be scheduled and seen at the same time, maximizing the number of
patients (and Ventavia’s payments) per day. However, seeing groups could potentially unblind
patients, could violate privacy laws, and violated the clinical trial’s 1:1 randomization protocol.
This practice would be apparent to Pfizer and Icon from overlapping times in the source
documents. Pfizer and Icon thus ignored obvious red flags of noncompliance.
201. Ventavia also did not maintain adequate principal investigator oversight. Dr. Mark
Koch, the principal investigator at Ventavia’s Fort Worth location, signed records for patients he
did not personally or adequately examine. Sub-investigator physicians or other medical staff
examined patients instead, and Dr. Koch “signed off” on the records. This issue was noted, for
example, during a “quality check” of Subject 11281278’s first injection visit at Ventavia’s Fort
Worth site, but never reported to Pfizer or Icon:
The document signed by Dr. Koch constitutes a false record because he did not actually examine
the patient. The same issue affected Subject 11281378’s first injection visit as well:
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202. To provide another example, no principal investigator signed records of Subject
1031’s screening visit on August 5, 2020. See Ex. 11, Ventavia’s Quality Control Findings, at 3.
Per Relator, this indicates that there was no principal investigator oversight for that subject’s visit.
203. This issue occurred because Ventavia was seeing too many clinical trial participants
per day. Principal investigator and sub-investigator physicians had their own medical practices to
oversee and could not stay at Ventavia test sites all day. Some investigator physicians even went
back and forth from their own offices to Ventavia multiple times per day.
204. The Houston site’s principal investigator, Dr. Van Tran, wanted to close his medical
practice during certain times, effectively setting aside scheduled “blocks” to examine clinical trial
participants at Ventavia. On August 15, 2020, Raney told Downs, Ray, Fisher, Livingston, and
another employee that Dr. Tran’s plan was not acceptable because the Houston site would not be
able to “hit” its cap of forty patients per week, maximizing its payments from Pfizer. See Ex. 21,
Daily Status Updates E-mail Chain, at 55–56. Raney wrote:
I understand that [Dr.] Tran had a different plan due to his patients and practice, but
we can't allow that kind of stuff to impact a high-enrolling study. I know you
brought this up on our call last week, but I didn't fully grasp the impact. In the
future, if you need to detour off of my recruitment guidance, I need you to seek
approval first before you agree or put anything into action. You brought the detour
up really quickly on our call and it was already in place when you told me about it,
so it was a little too late for me to say no (though I now realize I should have). The
direction was to see the 40 patients within the first 2.5 days...so that when Pfizer
did increase their [weekly] cap, we'd be the first ones approved for additional
drug[s] (and I did clearly explain my strategy and the rationale behind it when I
gave my direction). And now, Pfizer is planning to increase their drug and
[Houston] didn't hit their 40 in the first week. Honestly, that's unacceptable. I need
you to figure out how 9 patients will be randomized on Monday.
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Ex. 21, at 56. Raney’s directive exemplifies the focus on quick enrollment over protocol
compliance, and could have resulted in inadequate oversight by Dr. Tran at the Houston site.
205. Ventavia also did not report many clinical trial protocol deviations to Pfizer and
Icon. The issues, as previously noted, were often buried in “notes to the file” if they were reported
at all. Fisher acknowledged this as an ongoing issue on September 21, 2020, noting that she was
“not sure” if deviation reports were “getting completed or not[.]” Ex. 17, Fisher’s List of
Deficiencies, at 3.
10. Privacy Law Compliance
206. Defendant Ventavia’s Fort Worth location mishandled clinical trial participants’
protected health information, in violation of the Health Insurance Portability and Accountability
Act (“HIPAA”) and clinical trial protocol.
207. For example, on September 16, 2020, Relator observed that a wall calendar posted
near a reception area visible to all staff and patients contained patients’ names, phone numbers,
and health information (as a method of reminding staff to follow up with patients). Both medical
and non-medical staff could see this information. That same day, Relator also observed that patient
files had been left out unattended in an area where they were visible to non-medical staff.
208. On September 21, Fisher documented common findings during document “quality
checking” and noted that Ventavia’s test sites were inconsistent in safeguarding patients’ protected
health information, describing, for example, “patient folders out on counters in the clinic and face[]
up with names visible[.]” Ex. 17, Fisher’s List of Deficiencies (Sept. 21, 2020), at 1.
209. Ventavia employees at all three test sites regularly utilized the smartphone and
computer application “Slack” for communication, including patients’ names and identification
numbers. Slack is not secure or HIPAA-compliant.
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210. Ventavia’s HIPAA violations are a violation of the clinical trial protocol, which
requires compliance with all “applicable privacy laws.” Ex. 7, at 116.
B. Violation of FDA Regulations
211. Defendants’ clinical trial also violated FDA regulations, as explained further below.
As noted previously, Icon and Ventavia are bound by FDA regulations to the same extent and
degree as Pfizer. See 21 C.F.R. §§ 312.50, 312.52, 312.56; Ex. 7, at 116.
212. Defendants violated FDA regulations regarding IRB oversight and reporting when
they failed to report additional clinical trial participant compensation, failure to follow clinical trial
protocols, and informed consent violations to the clinical trial’s IRB. See 21 C.F.R. §§ 312.66,
312.53(c).
213. Defendants violated FDA regulations when they failed to investigate and report all
adverse event information received in the clinical trial at issue, and failed to notify the FDA of all
potential serious risks and adverse reactions. See 21 C.F.R. §§ 312.32, 312.50. Defendants
Ventavia and Icon violated 21 C.F.R. § 312.64(b) when they failed to immediately report all
adverse events to Pfizer.
214. Defendant Pfizer violated 21 C.F.R. § 312.50 and 21 C.F.R. § 312.56 when it failed
to properly oversee Defendants Ventavia and Icon and failed to ensure that they complied with the
clinical trial protocol.
215. Defendants Pfizer and Icon also violated FDA regulations when they learned of
Defendant Ventavia’s regulatory and protocol violations and elected not to “promptly . . . secure
compliance” or “discontinue shipments of [BNT162b2] and end [Ventavia’s] participation” in the
clinical trial. 21 C.F.R. § 312.56(b).
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216. Ventavia and Icon violated 21 C.F.R. § 312.64 by failing to furnish all required
reports to Pfizer, including but not limited to reports of adverse events, temperature excursions,
and clinical trial protocol deviations.
217. Defendant Ventavia violated 21 C.F.R. § 312.62 by failing to maintain adequate
and accurate records of BNT162b2 dispensation and clinical trial participants’ case histories.
218. Defendants violated FDA regulations by failing to obtain and document informed
consent for every patient prior to clinical trial participation. See 21 C.F.R. §§ 50.27(a), 312.60,
312.62(b).
219. Defendant Ventavia violated FDA regulations by giving BNT162b2 to subjects not
under the personal supervision of the principal investigators or sub-investigators at its clinical trial
sites. See 21 C.F.R. § 312.61.
220. Defendant Ventavia violated 21 C.F.R. § 312.61 by administering BNT162b2 to
ineligible clinical trial participants and to Ventavia employees and their family members.
221. Defendants’ violations of FDA regulations constitute a violation of the clinical trial
protocol as well. See Ex. 7, Clinical Trial Protocol, at 116 (requiring compliance with all
applicable laws and regulations).
222. Defendants violations of FDA regulations rendered their certifications and
representations of compliance in Pfizer’s claims for payment, the clinical trial protocol, Form
FDA-1571, and Form FDA-1572 false.
C. Violation of FAR
223. As previously noted, Defendant Pfizer is required to comply with FAR. Defendant
Pfizer did not maintain due diligence to detect and did not disclose Defendants’ violations of the
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False Claims Act to DoD. Defendant Pfizer has, as a result, breached its contract with DoD and
violated federal regulations. See 48 C.F.R. § 52.023-13.
224. Additionally, Pfizer did not monitor its subcontractors, Icon and Ventavia, as it was
required to do by FAR 42-202(e)(2). See 48 C.F.R. § 42-202(e)(2).
D. Ongoing Monitoring Concerns
225. Enrollment in the trial at issue has closed and only required ongoing patient
monitoring is still taking place. The fraud alleged herein also affects this ongoing monitoring.
Due to Defendants’ aforementioned fraudulent practices, data from ongoing monitoring
(including possible new adverse events) may be falsified or concealed, preventing material
information about BNT162b2 from reaching the United States.
E. Safety and Ethical Issues
226. Relator observed fundamental safety risks to study participants and Ventavia
employees, over and above those which violate the clinical trial protocol. She also observed
breaches of ethical standards required in clinical trials.
227. On September 16, Relator observed used needles placed in biohazard bags instead
of sharps containers. The bags are not puncture-proof, so Ventavia employees were directly put
at risk of injury or infection during bag handling and disposal.
228. Ventavia internally requires every patient’s chart to contain dosage ranges for
epinephrine based on weight, age, and other factors. Epinephrine is used to counter anaphylaxis
if a patient has an allergic reaction to a vaccine. Relator observed and reported to Ventavia
management that the protocol was not being followed. The deficiency could lead staff to
incorrectly guess the correct epinephrine dosage in an emergency, putting patients’ safety and lives
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at risk. Relator reported this issue to Ventavia supervisors verbally and via e-mail, including on
September 23 and 24, 2020. The issue was not remedied, to Relator’s knowledge.
229. To adhere to industry-standard “Good Clinical Practices,” Ventavia trial site
employees were required to undergo training in biologics handling, occupational safety and health,
and other areas. Relator strove to ensure that all employees underwent and reported their training,
but was terminated before this task was complete. To Relator’s knowledge, Ventavia never
provided all employees with all required training.
230. Ventavia and other trial sites for the Pfizer-BioNTech trial must get IRB approval
for all compensation paid to clinical trial participants. Ventavia, however, routinely gave
participants gift cards as a “customer service” initiative, to apologize for long patient wait times.
For example, on August 17, 2020, Ray directed Fisher and Downs as follows:
Let your [Site Operations Managers] know that sometimes we need to use kindness
to deal with difficult patients (purchase lunch, a coffee, small gift card, apologize,
etc.) Make it right when they are in the office, don’t wait until they leave upset
and go write reviews or report us to the IRB, FDA. Customer service is
everything.
Ex. 28, List of Action Items, at 13 (emphasis added). Providing gift cards to clinical trial
participants constitutes additional patient compensation not approved by the IRB and is a breach
of ethical obligations.
231. Ventavia did not report any of the above misconduct to the IRB or Pfizer.
IX. RETALIATION AGAINST RELATOR
232. Defendant Ventavia Research Group, LLC (“Ventavia”) retaliated against Relator
in response to her reports of, and efforts to stop, Defendants’ fraud against the United States DoD.
233. Relator began her employment with Ventavia on September 8, 2020 as a Regional
Director.
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234. As Regional Director, Relator oversaw site managers, patient recruitment success,
training completion, quality assurance completion, enforcement of communication paths, and
growth plans at her assigned test sites. These duties included ensuring that Serious Adverse Event
(“SAE”) reports were timely submitted, and that her assigned sites created corrective action plans
to address protocol deviations. Relator’s job duties also included daily and weekly communication
with the site operations managers of her assigned test sites and Ventavia’s leadership team.
235. Relator was responsible for the duties above at two of Ventavia’s three test sites for
the clinical trial at issue, located in Fort Worth and Keller, Texas. The third site involved, in
Houston, was overseen by another Regional Director and managed by Lovica “Kandy” Downs.
The Fort Worth site was managed by Jennifer Vasilio and the Keller site was managed by Katie
Benitez.
236. The principal investigators for the three sites at issue are medical doctors: Mark
Koch, M.D. (“Dr. Koch”) in Fort Worth, Gregory Fuller, M.D. in Keller, and Van Tran, M.D. in
Houston. The doctors are not employees of Ventavia; they serve as principal investigators in
addition to practicing medicine elsewhere. Ventavia and the principal investigators were paid by
Pfizer for supervision of the study on a per-patient basis, with additional funds paid per SAE
reported and for activities such as training.
237. Relator’s direct supervisor during her employment with Ventavia was Director of
Operations Marnie Fisher (“Fisher”). Her other superiors were Ventavia’s Executive Directors
Olivia Ray (“Ray”) and Kristie Raney (“Raney”) and the Chief Operating Officer, Mercedes
Livingston (“Livingston”).
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A. Relator begins her efforts to stop fraud on the United States Department of Defense.
238. Beginning on September 8, 2020, Relator reported on a near-daily basis to Fisher
and Livingston that patient safety and the integrity of the Pfizer-BioNTech vaccine trial was at
risk, via telephone, conversation, and e-mail. Relator discussed virtually all of the clinical trial
protocol and FDA regulatory violations she witnessed with Livingston, Raney, and Fisher,
including, but not limited to: (1) enrollment and injection of ineligible trial participants; (2)
falsification of data, poor recordkeeping, and the deficiency of Ventavia’s documentation “quality
control”; (3) deficiencies in and failure to obtain informed consent from trial participants; (4)
adverse event and SAE capture and reporting; (5) failure to preserve blinding; (6) vaccine dilution
errors; (7) failure to list all staff on delegation logs; (8) principal investigator oversight; (9)
reporting temperature excursions; (10) patient safety issues, such as not keeping epinephrine dose
information in patient charts; (11) failure to secure and record staff training required by clinical
research standards; (12) use of unqualified staff as vaccinators; (13) use of biohazard bags for
needle disposal; and (14) failure to properly monitor patients post-injection.
239. In general, every time that Relator raised concerns about safety or Ventavia’s
clinical trial protocol compliance with Fisher, she was told to e-mail Fisher about the issue or make
a list of affected patients. Many of the identified issues were systemic, and Relator did not have
access to information required to make the lists Fisher requested. Relator did as Fisher requested
to the extent that she was able, but the identified problems were never addressed. See Ex. 3,
Transcript of Sept. 24 Meeting (discussing, in part, Relator’s prior reports of protocol violations).
240. Relator also reported some clinical trial protocol violations to the Fort Worth
Principal Investigator, Dr. Koch. In particular, Relator discussed Ventavia’s practice of “quality
checking” patient source documents after the fact and issues of missing documentation. Dr. Koch
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acknowledged that Ventavia needed to “clean up” the problems before starting any new clinical
trials.
241. Ventavia was required to scan or enter all data from clinical trial participants’
source documents into its Clinical Trial Management System Database, so that it could be passed
on to Icon and Pfizer. Ventavia “quality checked” all source documents before scanning or
uploading them. In Ventavia’s scramble to enroll as many participants as possible per week and
maximize revenue, quality checking and uploading fell behind schedule. Relator observed that the
“back log” of documents to be quality checked often lacked key information, such as patient or
doctor signatures and blood draw times. Relator also observed that Ventavia’s quality checking
process was performed by unqualified personnel not listed on delegation logs, and often involved
falsification of missing data. Relator reported her concerns to Ventavia management, who seemed
more concerned with “catching up” on quality checking than preventing fraud.
242. On September 15, 2020, Relator reported to Fisher that some patient charts had
never been sent to Pfizer, were needed “urgently,” and had not been quality checked. See Ex. 29,
Text Messages with Fisher, at 1.
243. Relator called Ventavia’s contact at Pfizer for the trial at issue, Dr. Arturo Alfaro
(“Dr. Alfaro”) on September 14 and 16 to discuss protocol violations, but was unable to reach him.
B. Relator photographs violations.
244. On September 16, 2020, Relator examined some of the biohazard disposal bags at
Ventavia’s Fort Worth site. She had been asked to monitor this issue because Ventavia was
charged by weight for disposal of the bags, and non-biohazard items were sometimes improperly
placed there. Relator discovered that used needles had been disposed of in the bags:
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See also Ex. 3, Transcript of September 24 Meeting Recording, at 1–2. Biohazard bags are not
puncture-proof, so this presented a serious risk to employees’ safety.
245. That same night, Relator photographed ongoing HIPAA violations. Ventavia kept
a calendar of patients to follow up with in public view in a reception area. The calendar contained
patients’ names and information. Similarly, patient records were left out in public view. Relator
also documented that product cartons and patient randomization numbers from the BioNTech-
Pfizer vaccine trial had been left in public view in a preparation area, potentially unblinding all
Ventavia staff at the site and some patients as well:
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246. Relator shared her photographs from September 16 with Livingston and Fisher via
text message or e-mail. The following day, she reported an identical biohazard bag issue at the
Keller site to the same people.
C. Relator recommends pausing clinical trial enrollment.
247. On September 17, 2020, Relator spoke to Downs and Ventavia’s Quality Control
Director William Jones (“Jones”) via telephone. Relator asked both for their opinion about what
would happen if the FDA audited Ventavia. Both Downs and Jones responded the same way—
afraid that Ventavia would receive warning letters or be asked to discontinue trial enrollment.
248. Later that day, in her daily phone call with Ray, Raney, Fisher, Downs, and
Livingston, Relator brought up virtually all of the protocol and regulatory violations she had
witnessed to date, as well as Ventavia’s HIPAA violations. Relator explained that the FDA would
likely issue warning letters against Ventavia if it visited or audited the trial sites. She
recommended that Ventavia immediately stop enrollment in the Pfizer-BioNTech clinical trial.
249. Ray directed Relator and others to conduct FDA trainings, in preparation for a
possible future site visit or audit by the FDA. See Ex. 28, List of Action Items, at 1; Ex. 1, Text
Messages with Ray and Others (Sept. 17, 2020), at 1. Ventavia also decided to pause enrollment
in order to catch up on “quality checking” source documents. Id.
250. Later on September 17, Relator responded to a group text message including Ray,
Downs, Raney, Livingston, and Fisher. See Ex. 1, at 2. First, Relator passed on the concerns of
Fort Worth Site Operations Manager Jennifer Vasilio regarding documentation and patient
observation protocol violations, patients being injected outside of the nineteen to twenty-three day
“window,” and HIPAA violations. Ex. 1, at 1. Second, Relator expressed her concerns about
Ventavia’s “quality checking” (QC):
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I would like us to create a solid monitoring plan . . .
I don’t think it is as simple as pulling a chart and looking for missing check boxes
or missing initial in a header/footer which I have been seeing a lot of when I have
QC’d the QC’er.
We need to be able to reconcile time of [vaccine] prep and admin[istration], for
example. This cannot be done by everyone who is QC’ing to ensure we do maintain
the blind. This is one reason I think we need to carefully consider what we are
looking at especially if we are approaching this from the perspective of an FDA
auditor, which I 100% think we should be. . . .
I would have liked the opportunity to discuss this with [the principal investigators,
Drs. Fuller and Koch] individually and I still would.
Ex. 1, Text Messages with Ray and Others (Sept. 17, 2020), at 2. The “reconcil[ing]” Relator
discussed showed that vaccine preparation and administration times were not compliant with the
clinical trial protocol. Id.
251. Ventavia was not up-front with Pfizer and Icon about the reasons for the enrollment
pause (sloppy documentation that violated the clinical trial protocol). In a text message
conversation on September 17, Raney instructed Ventavia employees how to respond to any
questions from Pfizer about the pause. She told them to “make it like it’s no big deal” and that the
pause resulted from Ventavia was “being responsible by considering we have a certain bandwidth
and these visits on top [of] each other has hit our bandwidth.” Ex. 1, at 10. Raney also directed
employees to falsely tell patients that Ventavia was not enrolling because “we met our company
capacity[.]” Ex. 1, at 6. Ventavia was also not up-front with its Houston principal investigator,
Dr. Van Tran, regarding the reason for the pause. Downs was directed to convey to Dr. Tran that
the pause was due to Ventavia being “at capacity” and not wanting “to overd[o] it.” Ex. 1, at 9.
252. Ventavia ultimately elected to schedule patients for several weeks later rather than
truly and completely pause enrollment. See Ex. 1, at 6, 9–10. Raney directed employees not to
cancel any patients already “on their way” to test sites because “that might piss them off and they
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can call the news, etc[.]” Ex. 1, at 11. Livingston responded, “if [patients] were scheduled far
enough out[,] cancel[,] but if they are there then see them.” Id. Downs responded that she would
not cancel patients in Houston. See id.
253. During the enrollment pause, Ventavia’s “quality checking” not only failed to
correct documentation violations but also involved falsification of missing or inconsistent data.
Ventavia hired employees’ friends and family members on a temporary basis to perform quality
checking who were not adequately trained. Relator even personally observed employees falsifying
source document data (i.e., by changing blood pressure readings). Relator also noticed that
information was often completely obscured when changed, rather than “lining through” (which
preserves legibility of the original text). In short, Ventavia’s “quality checking” failed to prevent
or stop fraud on the United States DoD.
254. On September 23, 2020, Relator e-mailed Ray, Fisher, Raney, Downs, Jones, and
Livingston to report ongoing serious issues with Ventavia’s “quality checking.” See Ex. 2, E-mail
Chain with Ray and Others (Sept. 23, 2020). Relator noted, among other issues:
• There were 100 outstanding queries from Icon about missing or inconsistent data
which were up to twenty-eight days old. See Ex. 2, at 1.
• Scheduling errors resulted in multiple patients receiving their second injection
outside of the required nineteen to twenty-three day window. Ventavia was not
truthfully recording the vaccine delay for these patients, and due to the oversight,
Pfizer and Icon could not discover that these patients were vaccinated outside of the
permissible window. Id.
• Quality checking caused large delays. Relator found a twenty-one-day-old patient
chart that had not been entered into the Electronic Data Capture system to send to
Icon and Pfizer. That information should have been entered within twenty-four
hours. Id.
• Some patient charts and laboratory specimens were missing. Id.
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Due to the seriousness of these violations, Relator noted that she “might be in a little bit of shock.”
Ex. 2, at 1.
255. On September 23, 2020, Relator e-mailed Livingston to report that Ventavia’s
emergency response protocol for allergic reactions was not being followed. Ventavia internally
required every patient’s chart to contain appropriate dosage ranges (based on age, weight, etc.) for
epinephrine in the event of anaphylaxis. The patients’ charts did not contain this information. No
action was taken to correct this during Relator’s employment.
D. Ventavia management falsely accuses Relator of violating patient confidentiality.
256. On the evening of September 24, 2020, Relator met with Fisher and Jones. See Ex.
3, Transcript of September 24, 2020 Meeting Recording. The meeting was arranged to discuss
Relator’s photographic documentation of safety issues, HIPAA violations, and unblinding from
September 16. The meeting quickly escalated into harassment. Fisher questioned repeatedly why
Relator took the photographs and falsely accused Relator of removing patient source documents
from another Ventavia location. Id.
257. Fisher reiterated her instructions to provide specific patient names which, as noted
previously, was not always possible. See Ex. 3, at 4, 18, 20, 22. Fisher and Jones gave
contradictory instructions, telling Relator to fix violations once identified but also noting that
Ventavia cannot correct all violations, and has to pick and choose what to address. See, e.g., Ex.
3, at 12, 15, 27. Jones stated that Ventavia had not “even finished quantifying the number of
errors” because “it’s something new every day.” Ex. 3, at 12. He acknowledged that the problems
were “not just in one site” either, and stated “we’re gonna get some kind of letter of information
at least, when the FDA gets here. Know it.” Id.
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258. When Relator discussed her unblinding documentation, Fisher appeared more
concerned with punishing the employees responsible for the unblinding incident than preventing
the issue in the future. See Ex. 3, at 2, 3; see also Ex. 13, Unblinding E-mail Chain (Sept. 22,
2020), at 1 (instructing employees to discipline those responsible for unblinding incident).
259. Relator specifically referenced FDA regulatory violations in her conversation with
Fisher and Jones. See Ex. 3, Transcript of September 24, 2020 Meeting Recording, at 14. She
told Fisher and Jones that if they did not see what she saw when quality checking patients’ source
documents, then they needed to “get on Google” and search for FDA warning letters. Ex. 3, at 14.
260. Relator reported hearing Raney and Ray acknowledge via telephone that Ventavia
did not have the staff or patient room capacity to handle the number of clinical trial participants
being seen every day. Ex. 3, at 15. Relator questioned whether Raney and Ray truly prioritized
patient safety. See id. Fisher questioned whether placing patients in the hallway for “monitoring”
after injection was actually a safety risk. Id.
261. Relator also discussed with Jones and Fisher that Downs had previously reported
many of the same violations and safety risks that Relator had. See Ex. 3, at 21, 23–24. Fisher
claimed that Ventavia addressed Downs’ concerns, but clearly the same issues had recurred, or
else Relator would not have spotted them. See Ex. 3, at 24.
E. Ventavia terminates Relator the next day.
262. On the following morning, Relator called the FDA’s hotline to report the clinical
trial protocol violations and patient safety concerns she witnessed.
263. Relator was terminated from her position at Ventavia that same day—September
25, 2020. Relator was never formally disciplined or reported for any failure regarding her job
performance until the day that she was terminated.
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264. Relator was harassed and terminated by Defendant Ventavia as a direct
consequence of her reports of and efforts to stop fraud against the United States DoD.
265. After Relator was terminated, she called Dr. Alfaro at Pfizer and gave a general
overview of her concerns about unblinding, principal investigator oversight, and patient safety in
the Pfizer-BioNTech vaccine trial. She also informed Dr. Alfaro that she had contacted the FDA.
Relator did not identify herself or discuss any specific trial sites, concerned that doing so might
adversely affect a future retaliation action.
266. Not long after her termination, the FDA contacted Relator and spoke to her for
several hours regarding the violations she witnessed at Ventavia.
267. Almost immediately after Relator was terminated (the next business day), Ventavia
lifted the enrollment “pause” and resumed the push to enroll as many clinical trial participants per
week as possible. Given the amount of “quality control” left to be performed when Relator was
terminated, Relator estimates that Ventavia had neither completed quality checking nor remedied
its ongoing violations by the time it resumed enrollment.
268. Relator’s termination is but one example of a pattern and practice of retaliatory
terminations by Defendant Ventavia. Ventavia’s prior Fort Worth Site Operations Manager
Michelle Gaines was terminated in August of 2020 for reporting and trying to stop protocol
noncompliance and regulatory violations in other clinical trials.
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X. ACTIONABLE CONDUCT BY DEFENDANTS
A. False Claims Act
1. Applicable Law
269. This is an action to recover damages and civil penalties on behalf of the United
States and Relator Jackson arising from the false and/or fraudulent statements, claims, and acts
that Defendants made in violation of the False Claims Act, 31 U.S.C. §§ 3729–3732.
270. For conduct occurring on or after May 20, 2009, the FCA provides, in relevant part,
that any person who:
(A) knowingly presents, or causes to be presented, a false and/or
fraudulent claim for payment or approval; [or]
(B) knowingly makes, uses, or causes to be made or used, a false record
or statement material to a false and/or fraudulent claim[,]
31 U.S.C. § 3729(a)(1), is liable to the United States for a civil penalty of not less than $11,665
and not more than the applicable regulatory maximum for each such claim, plus three times the
amount of damages sustained by the Government because of the false and/or fraudulent claim. See
31 U.S.C. § 3729(a)(1); 28 C.F.R. § 85.5.
271. The FCA defines “claim” as:
(A) mean[ing] any request or demand, whether under a contract or
otherwise, for money or property and whether or not the United
States has title to the money or property, that--
(i) is presented to an officer, employee, or agent of the United
States; or
(ii) is made to a contractor, grantee, or other recipient, if the
money or property is to be spent or used on the
Government’s behalf or to advance a Government program
or interest, and if the United States Government--
(I) provides or has provided any portion of the money or
property requested or demanded; or
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(II) will reimburse such contractor, grantee, or other
recipient for any portion of the money or
property which is requested or demanded. . . .
31 U.S.C. §3729(b)(2).
272. The FCA allows any person having knowledge of a false and/or fraudulent claim
against the Government to bring an action in federal district court for himself and for the United
States, and to share in any recovery, as authorized by 31 U.S.C. § 3730.
273. Based on these provisions, Relator Jackson seeks damages and civil penalties
arising from Defendants’ violations of the False Claims Act.
2. Defendants’ Violations of the False Claims Act
a. Presentation of False Claims (31 U.S.C. § 3729(a)(1)(A))
274. From 2020 to the present, Defendants knowingly presented, or caused the
presentment of, false and/or fraudulent claims for payment or approval to the United States.
Pfizer’s claims for payment to DoD were rendered false and/or fraudulent by express and implied
false certifications.
275. First, when Defendant Pfizer submitted its clinical trial protocol to the United States
in connection with its contract, it represented that the clinical trial would comply with all applicable
laws and regulations. Defendants violated FAR and multiple FDA regulations when conducting
the clinical trial, rendering this certification false.
276. Second, Defendant Pfizer’s IND for the vaccine and clinical trial at issue warned
that making a “willfully false statement is a criminal offense.” Ex. 4, Form FDA-1571, at 2.
Defendants rendered Pfizer’s acknowledgement of this warning false by submitting false data to
the FDA.
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277. Third, Defendants Ventavia and Icon certified in Form FDA-1572, submitted to
Pfizer and the United States, that they would: (1) conduct the trial in accordance with the protocol
and FDA regulations; (2) obey informed consent and IRB reporting requirements; (3) report
adverse events; (4) ensure that all “associates, colleagues, and employees assisting in” the trial
were “informed about their obligations”; and (5) make no changes to the trial without IRB
approval. B, Form FDA-1572; 21 C.F.R. § 312.53(c)(vi). Ventavia and Icon acknowledged when
submitting Form FDA-1572 that making willfully false statements is a crime. See Ex. 5, at 2. This
acknowledgement and certification was rendered false by Ventavia and Icon’s violations of the
clinical trial protocol, FDA regulations, and fraudulent conduct described supra.
278. Fourth, 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.
See 48 C.F.R. § 52.232-32(m). This certification was rendered false by Defendants’ submission
of false data and violation of FDA regulations and FAR, and by the other fraudulent conduct
described supra.
279. Defendants’ fraudulent schemes transform these certifications into false
certifications, rendering Defendant Pfizer’s claims for payment to DoD false and/or fraudulent.
280. By creating and carrying out their fraudulent schemes, Defendants knowingly and
repeatedly violated Section 3729(a)(1)(A) of the False Claims Act.
281. Defendants’ knowing submission, or causation of submission, of false and/or
fraudulent claims had the potential to influence the government’s payment decision and was
material to the government’s decision to pay the claims.
282. Defendants’ violations of the applicable statutes and regulations, and
misrepresentations regarding their compliance, were material, because they went to the very
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essence of the bargain for which the United States DoD contracted. Had the United States DoD
known of Defendants’ fraudulent non-compliance, which resulted in the submission of ineligible
false and/or fraudulent claims for reimbursement, it would not have paid the claims.
283. Defendants’ presentment, or causation of presentment, of false and/or fraudulent
claims to the United States DoD was a foreseeable factor in DoD’s loss and a consequence of
Defendants’ schemes. By virtue of Defendants’ actions, the United States DoD has suffered actual
damages and is entitled to recover treble damages plus a civil monetary penalty for each false
and/or fraudulent claim.
b. Making or Using False Records or Statements to Cause Claims to be Paid (31
U.S.C. § 3729(a)(1)(B))
284. From 2020 to the present, Defendants knowingly made, used, or caused to be made
or used, false records or statements that were material to false and/or fraudulent claims paid or
approved by the United States DoD. These false records or statements include the clinical trial
protocol Pfizer submitted to the United States and the falsified source documents and data behind
Defendants’ trial results and EUA application.
285. By creating and carrying out their fraudulent schemes, Defendants knowingly and
repeatedly violated Section 3729(a)(1)(B) of the False Claims Act.
286. Defendants’ false records were material to Pfizer’s claims for payment for the
vaccine at issue. The United States DoD would not have paid Pfizer if it knew that the clinical
trial protocol was not complied with by Defendants, because the protocol violations call the
integrity and validity of both the entire clinical trial and Pfizer’s EUA into question.
287. Defendants’ false records also went to the very essence of the bargain the United
States contracted for. DoD contracted to purchase vaccines found effective by a valid clinical trial
conducted according to the protocol submitted by Pfizer. The integrity of the entire clinical trial
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was compromised by the trial protocol violations, false source documents, and the false data that
resulted, which calls the vaccine’s EUA into question. Had the United States DoD known of
Defendants’ false records, it would not have paid Pfizer.
288. Defendants’ use, or causation of use, of material false records was a foreseeable
factor in the United States DoD’s loss and a consequence of Defendants’ schemes. By virtue of
Defendants’ actions, the United States DoD has suffered actual damages and is entitled to recover
treble damages plus a civil monetary penalty for each false and/or fraudulent claim.
c. Retaliation (31 U.S.C. § 3730(h))
289. Section 3730(h) of Title 31 of the United States Code defines whistleblower
protection under the False Claims Act as follows:
(1) Any employee, contractor, or agent shall be entitled to all relief necessary to
make that employee, contractor, or agent whole, if that employee, contractor, or
agent is discharged, demoted, suspended, threatened, harassed, or in any other
manner discriminated against in the terms and conditions of employment because
of lawful acts done by the employee, contractor, agent or associated others in
furtherance of an action under [the False Claims Act] or other efforts to stop 1 or
more violations of [the False Claims Act].
(2) Relief . . . shall include reinstatement with the same seniority status that
employee, contractor, or agent would have had but for the discrimination, 2 times
the amount of back pay, interest on the back pay, and compensation for any special
damages sustained as a result of the discrimination, including litigation costs and
reasonable attorneys’ fees.
31 U.S.C. § 3730(h).
290. As discussed supra, in violation of 31 U.S.C. § 3730, Defendant Ventavia retaliated
against Relator as a result of Relator’s efforts to stop Defendants from committing False Claims
Act violations. Defendant Ventavia punished Relator for her lawful and statutorily protected
activity with harassment and termination.
291. Relator has suffered both economic loss and emotional harm as a result of
Defendant Ventavia’s retaliatory actions.
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XI. CAUSES OF ACTION
A. Count I – Presentation of False and/or Fraudulent Claims (31 U.S.C. § 3730(a)(1)(A))
292. Relator realleges and hereby incorporates by reference each and every allegation
contained in all paragraphs of this Complaint.
293. Since December of 2020, Defendants have knowingly presented or caused the
presentment of false and/or fraudulent claims to the United States for payment or approval.
Defendant Pfizer’s claims for payment to DoD were rendered false or fraudulent by Defendants’
implied and express false certifications of legal and regulatory compliance, accuracy of data, and
clinical trial protocol compliance.
294. By creating and carrying out their fraudulent scheme, Defendants knowingly and
repeatedly violated the False Claims Act. See 31 U.S.C. § 3729(a)(1)(A).
295. Defendants’ knowing submission, or causation of submission, of false and/or
fraudulent claims had the potential to influence the United States’ payment decision and was
material to the United States’ decision to pay the claims.
296. The United States paid the false and/or fraudulent claims.
297. Defendants’ presentment or causation of presentment of false and/or fraudulent
claims was a foreseeable factor in the United States’ loss and a consequence of Defendants’
fraudulent scheme. By virtue of Defendants’ actions, the United States has suffered damages and
is entitled to recover treble damages plus a civil monetary penalty for each false and/or fraudulent
claim.
B. Count II – Making or Using False Records or Statements Material to False and/or
Fraudulent Claims (31 U.S.C. § 3730(a)(1)(B))
298. Relator realleges and hereby incorporates by reference each and every allegation
contained in all paragraphs of this Complaint.
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299. From 2020 to the present, Defendants knowingly made, used, or caused to be made
or used, false records or statements that were material to false and/or fraudulent claims paid or
approved by the United States. These false records or statements include the clinical trial protocol
that Defendant Pfizer submitted to the United States and the falsified source documents and data
behind Defendants’ clinical trial results and Emergency Use Authorization application.
300. By creating and carrying out their fraudulent scheme, Defendants knowingly and
repeatedly violated 31 U.S.C. § 3729(a)(1)(B).
301. Defendants’ false records or statements, or causation thereof, had the potential to
influence the United States’ payment decision and were material to the United States’ decision to
pay the claims.
302. Defendants’ false records or statements, or causation thereof, were material because
they went to the very essence of the bargain for which the United States contracted. Had the United
States known of Defendants’ fraudulent misrepresentations regarding the clinical trial at issue,
which resulted in the submission of ineligible false/fraudulent claims for reimbursement, then the
United States would not have paid those claims.
303. The United States paid the false and/or fraudulent claims.
304. Defendants’ false records or statements, or causation thereof, was a foreseeable
factor in the United States’ loss and a consequence of Defendants’ scheme. By virtue of
Defendants’ actions, the United States has suffered actual damages and is entitled to recover treble
damages plus a civil monetary penalty for each false and/or fraudulent claim.
PRAYER FOR RELIEF
305. WHEREFORE, Relator prays that this Court enter judgment against Defendants
and award the following:
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(1) Damages in the amount of three (3) times the actual damages suffered by the United
States as a result of Defendants’ conduct;
(2) Civil penalties against Defendants up to the maximum allowed by law for each
violation of 31 U.S.C. § 3729;
(3) The maximum award Relator may recover pursuant to 31 U.S.C. § 3730(d);
(4) All costs and expenses of this litigation, including attorneys’ fees and costs of court;
and
(5) All other relief on behalf of Relator or United States that the Court deems just and
proper.
C. Count III – Retaliation (31 U.S.C. § 3730(h))
306. Relator realleges and hereby incorporates by reference each and every allegation
contained in all paragraphs of this Complaint.
307. In violation of 31 U.S.C. § 3730(h), Defendant Ventavia Research Group, LLC
(“Ventavia”) retaliated against Relator Jackson as a result of her efforts to stop Defendants from
committing violations of the False Claims Act.
308. Ventavia punished Relator for her lawful and statutorily protected activity with
harassment, termination, and slander.
309. Relator has suffered economic loss and emotional harm as a result of her
termination by Ventavia.
PRAYER FOR RELIEF
310. WHEREFORE, Relator prays that this Court enter judgment against Defendant
Ventavia Research Group, LLC for the following:
(1) Reinstatement with the same seniority status;
(2) Two times the amount of Relator’s back pay;
(3) Interest on Relator’s back pay;
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(4) Compensation for special damages sustained by Relator as a result of Defendants’
actions, including but not limited to compensatory damages for emotional pain, suffering,
inconvenience, mental anguish, loss of enjoyment of life, loss to reputation, and other
pecuniary and nonpecuniary losses;
(5) Punitive damages;
(6) Litigation costs and attorneys’ fees;
(7) Prejudgment interest at the highest rate allowed by law; and
(8) Any other relief that the Court deems just and proper to make Relator whole.
XII. INDEX OF EXHIBITS
311. The exhibits referenced herein consist of the following:
Exhibit Description Bates Range
Number
1 Text Messages with Ray and Others (Sept. 17, 2020) JSN0001-JSN0011
2 E-mail Chain with Ray and Others (Sept. 23, 2020) JSN0012-JSN0014
3 Transcript of September 24, 2020 Meeting JSN0015-JSN0046
4 Form FDA-1571 JSN0047-JSN0049
5 Form FDA-1572 JSN0050-JSN0051
6 BNT162b2 Product Manual JSN0052-JSN0135
7 Clinical Trial Protocol JSN0136-JSN0281
8 Pfizer Press Release (Nov. 18, 2020) JSN0282-JSN0287
9 E-mail Chain with Downs and Others (Sept. 18, 2020) JSN0288-JSN0292
10 Pfizer-DoD Contract JSN0293-JSN0327
11 Ventavia’s Quality Control Findings JSN0328-JSN0351
12 E-mail Chain with Raney (Sept. 17, 2020) JSN0352-JSN0357
13 Unblinding E-mail Chain (Sept. 22, 2020) JSN0358-JSN0359
14 Note to File on Randomization (Sept. 17, 2020) JSN0360
15 E-mail Chain with Downs and Alfaro JSN0361-JSN0364
16 E-mail Chain with Henslin (Sept. 15, 2020) JSN0365-JSN0369
17 Marnie Fisher’s List of Deficiencies (Sept. 21, 2020) JSN0370-JSN0373
18 Common Quality Assurance Findings Checklist (Sept. 22, JSN0374-JSN0377
2020)
19 E-mail Chain with Icon (Sept. 21, 2020) JSN0378-JSN0385
20 Informed Consent E-mail Chain with Alfaro and Others (Sept. JSN0386-JSN0391
24, 2020)
21 Daily Status Updates E-mail Chain JSN0392-JSN0457
22 E-mail Chain with Fisher, Raney, and Others (Sept. 9, 2020) JSN0458-JSN0460
23 E-mail Chain with Livingston, Vasilio, and Others (Sept. 22, JSN0461-JSN0464
2020)
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Exhibit Description Bates Range
Number
24 Mercedes Livingston’s List of Common Errors (Sept. 22, JSN0465-JSN0467
2020)
25 Blood Draw Data JSN0468-JSN0495
26 Source Documentation E-mail Chain (Sept. 10, 2020) JSN0496-JSN0497
27 Symptom Log E-mail Chain and Attachment (Sept. 24, 2020) JSN0498-JSN0503
28 List of Action Items JSN0504-JSN0521
29 Text Messages with Fisher (Sept. 14-15, 2020) JSN0522
XIII. DEMAND FOR JURY TRIAL
312. Pursuant to Federal Rule of Civil Procedure 38, Relator demands a trial by jury.
Dated: February 22, 2022 Respectfully submitted,
_/s/ Robert E. Barnes_____
Robert E. Barnes, Esq.
Subject to admission Pro Hac Vice
Lexis Anderson, Esq.
Member of the Eastern District of Texas
BARNES LAW
700 South Flower Street, Suite 1000
Los Angeles, California 90017
Telephone: (310) 510-6211
Email: robertbarnes@barneslawllp.com
Email: lexisanderson@barneslawllp.com
COUNSEL FOR RELATOR BROOK
JACKSON
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