Last year, a whistleblower lawsuit was filed with the United States District Court for the Eastern District of Texas Beaumont Division targeting Pfizer as a defendant. Filed by the plaintiff/Relator Brook Jackson, ex rel, the lawsuit alleges that Pfizer and two contract research organizations including ICON, Plc, and Ventavia Research Group LLC, committed egregious civil wrongs under the Federal False Claims Act. Although the case was filed quietly last year, there was little coverage associated with the actual lawsuit. Associated with the Pfizer COVID-19 vaccine called BNT162b2 (Comirnaty), the Texas whistleblower allegations were tracked by TrialSite, as well as the British Medical Journal (The BMJ); that prestigious medical journal was even censored by Facebook fact-checkers for reporting on the allegations of data manipulation and fraud associated with the whistleblower from Ventavia. If these allegations turn out to be true, the implications are frankly explosive for Pfizer, which has generated record revenues for the distribution of the COVID-19 vaccine. Not to mention for the federal government, which not only formally approved the vaccine but also issued mandates, forcing vaccinations as mandatory for employment, for example, in health care systems that received federal funding.
Demanding a jury trial, the plaintiff/relator Brook Jackson bought this action under the False Claims Act, 31 U.S.C. §§ 3729–3732, seeking to recover damages, penalties, and other possible remedies associated with this Act on behalf of the United States of America as well as on her own behalf totaling at least $2 billion.
What is the case?
Ms. Jackson comes up with over a dozen claims, which TrialSite breaks down in the table below:
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Defendants in a race to test the COVID-19 vaccine candidate “withheld crucial information from the U.S. government that raises material concerns of vaccine safety and efficacy. The Defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.”
Due to this claimed civil wrong, millions of Americans have received a misbranded vaccination, which is potentially not as effective as represented. 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.
Pfizer was able to secure $1.95 billion in U.S. federal procurements for the vaccine initially developed by BioNTech called BNT162b2.
This deal was based on a successful Phase 1 trial sponsored by BioNTech. The U.S. Federal gov. acquired 100 million doses.
Like many clinical trials, Pfizer delegated trial responsibilities to CROs, including ICON, a well-known Irish clinical trial outsourcing company.
ICON was responsible for recruiting and onboarding 160 trial sites worldwide ensuring trial protocol compliance and reporting including oversight of any Serious Adverse Events (SAE)—required by the study protocol, federal regulations, and international standards (e.g., GcP). Yet, Pfizer is ultimately responsible.
Ventavia Research Group, LLC, a named Defendant, was contracted by Pfizer to provide Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas.
This CRO (Ventavia) ultimately enrolled 1,500 patients for the trial. It was Ventavia that employed the Relator (Plaintiff) Brook Jackson serving the study as Regional Director. As such, the Relator was tasked with overseeing the trial site management, patient enrollment, quality, and event reporting, including corrective action plans, communication with management, and staff training at the three Texas-based trial sites.
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.
Jackson claims that this pressure to enroll combined with the payment incentive led to “sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight.” Did Pfizer and ICON turn a blind eye to Ventavia’s misconduct? The Plaintiff/Relator suggests there were plenty of warning signs that should have been noticed.
Relator/Plaintiff alleges in lawsuit widespread regulatory violations during her period of employment. Those observations included:
• 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 These allegations, if proven true, represent an egregious violation of federal compliance rules and violation of GcP principles.
Ventavia failed to report most 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.
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.
The whistleblower turned Plaintiff (Relator) Jackson claims that she continuously raises her concerns and observations to the management of Ventavia. Moreover, later on, the Plaintiff reported the problems to Pfizer as well.
What was the response? According to the Plaintiff, Ventavia ignored these serious allegations and started to harass Jackson instead. They terminated her for submitting reports in what the Plaintiff claims is an effort to perpetrate a fraud against the United States Department of Defense. Pfizer opted not to do anything with the Plaintiff’s reports.
While the Plaintiff’s observations were associated only with Texas-based trial sites, such mishaps, fraud, and concealment of blatant violations (if proven to be true) raise questions about the entire study.
Is it reasonable to assume that comparable activities were occurring at other trial sites? The Plaintiff suggests so.
By December 11, 2020, the FDA issued EUA to Pfizer-BioNTech for the BNT162b2 mRNA vaccine. DOD was a sponsor.
However, the Plaintiff claims that this decision was based on “falsified clinical trial results” in addition to the cover-up of vital trial information. The Plaintiff claims the DoD had purchased misbranded vaccines from Pfizer because they relied on the trial sponsor’s “fraudulent misrepresentations.” If the Plaintiff is correct, the trial wasn’t properly conducted.
The Plaintiff thus declares that if not for Pfizer, ICON, and Ventavia’s “fraudulent scheme,” the DOD would not have paid billions.
The Plaintiff declares that the U.S. Federal Gov (DOD) was bilked via fraud, misrepresentation, and obfuscation in a blatant violation of federal compliance laws. Meanwhile, the Defendants, especially Pfizer, have enjoyed windfall profits based on record-breaking revenue of around $30 billion in the first 12 months of the EUA.
TrialSite will continue to monitor this lawsuit. An interview of the Plaintiff can be viewed here. Check out the actual lawsuit here. The case can be accessed via Law360.comhere.