A whistleblower lawsuit alleging fraud during Pfizer’s COVID vaccine trials is moving forward, after a district court judge unsealed the complaint, including 400 pages of exhibits.
Jackson worked for Ventavia for a brief period in 2020 before being fired after she filed a complaint with the U.S. Food and Drug Administration (FDA) over alleged improprieties she observed during the vaccine trials.
She also gave The BMJ a cache of internal company documents, photos and recordings highlighting alleged wrongdoing by Ventavia.
Jackson filed the complaint in the U.S. District Court, Eastern District of Texas, Beaumont Division, under the False Claims Act. The lawsuit includes several charges of fraud and retaliation on the part of both Ventavia and Pfizer.
The complaint remained under seal until Feb. 10, when U.S. District Court Judge Michael Truncale ordered it unsealed.
Pfizer ‘deliberately withheld crucial information’ about vaccine’s safety
According to Jackson’s lawsuit, Pfizer, Ventavia and ICON “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”
The lawsuit states:
“Defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.
“Due to [the] Defendants’ scheme, millions of Americans have received a misbranded vaccination which is potentially not as effective as represented.”
The core allegations of Jackson’s lawsuit include claims against Ventavia and Pfizer of:
Making or using false records or statements to cause claims to be paid.
Presentation of false and/or fraudulent claims.
Making or using false records or statements material to false and/or fraudulent claims.
For instance, Jackson alleges:
“From 2020 to the present, Defendants [Ventavia and Pfizer] 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 [Department of Defense, or 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.
“By creating and carrying out their fraudulent schemes, Defendants knowingly and repeatedly violated … the False Claims Act. 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.
“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 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.
“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.”
Jackson is requesting damages, including back pay, in addition to reinstatement of her position with Ventavia.
Ventavia, which describes itself as the largest privately owned clinical research company in Texas, operated several sites where clinical trials were taking place on behalf of Pfizer.
Jackson, a regional director for Ventavia, was hired by the company when Pfizer contracted with it to conduct its phase 3 vaccine trial.
Jackson, who possessed over 15 years’ worth of experience working with clinical trials, “repeatedly informed her superiors of poor laboratory management, patient safety concerns and data integrity issues” during the approximately two weeks she was employed by Ventavia.
On Sept. 25, 2020, Jackson emailed the FDA, listing a dozen concerns she said she had witnessed. These included:
Lack of timely follow-up for patients who experienced adverse events from the trial. Protocol deviations that went unreported. Retaliation against and targeting of Ventavia employees who reported such problems.
Trial participants being placed in a hallway after injection and not being monitored by clinical staff. Vaccines not being stored at proper temperatures.
Wrongly labeled laboratory specimens. Jackson provided documents indicating falsified data, blind trial failures and awareness on the part of at least one Ventavia executive that members of the company’s staff were “falsifying data.”
Jackson’s documents also provided evidence of administrators who had “no training” or medical certifications, or who provided “very little oversight” during the trials.