Hearing on Pfizer Clinical Trial Violations Set to Take Place

A hearing has been scheduled for March 1 in a legal case brought by a whistleblower who confirmed that violations occurred during the Pfizer–BioNTech COVID-19 vaccine clinical trial.

Ventavia, a subcontractor for Pfizer’s COVID-19 vaccine Phase 3 clinical trial, failed to properly report adverse events and keep all participants blinded, according to internal communications revealed by Brook Jackson, the whistleblower. Ventavia and other companies were hired by ICON, a clinical research group that was paid by Pfizer, to run trial sites.

Jackson, who was hired by Ventavia in September 2020, worked on clinical trials for 18 years; one company official described her as an expert. She was fired 18 days after starting, on the same day she alerted the U.S. Food and Drug Administration (FDA) to the trial issues.

Jackson sued Ventavia, Pfizer, and ICON in 2021 for violating the False Claims Act, a law that prohibits knowingly making a false or fraudulent claim for payment or approval from the government. She also accused Ventavia of illegal retaliation.

The case was unsealed in 2022 after the U.S. government declined to back Jackson.

Next week, U.S. District Judge Michael Truncale, a Trump appointee, will hear oral arguments on the defendants’ motions to dismiss. The Epoch Times plans to attend the hearing, which is currently designated in-person only.

Arguments

Under the False Claims Act, U.S. citizens can file suit on behalf of the government. Lawsuits are brought under the act against people or entities accused of defrauding the government.

Pfizer signed a contract in 2020 with the U.S. Department of Defense, which agreed to buy up to 100 million doses of the Pfizer–BioNTech COVID-19 vaccine for $1.95 billion, pending authorization or approval by U.S. regulators.

Ventavia’s violations of the trial protocol, as well as ICON’s and Pfizer’s failure to properly oversee the trial, means that the FDA’s December 2020 authorization was “based in part on Defendants’ falsified clinical trial results and concealment of key information,” the suit states.

Jackson, through her lawyers, argues that the U.S. government wouldn’t have purchased the vaccines had it known of the violations. That means the government was defrauded, the suit asserts. The contract states that government must pay for vaccine doses after authorization unless the FDA withdrew the authorization.

Pfizer told the court in a motion to dismiss that because the agreement was a “prototype,” a federal regulation that guides most other contracts doesn’t apply. It also noted that the FDA authorized the vaccine after hearing from Jackson, who informed the regulator of issues she witnessed.

ICON said that it was aware of concerns with the trial but that it worked to “address and ameliorate them as the study progressed.” The company said that the complaint “falls far short of pleading any viable claim against ICON.”

Ventavia said that even if Jackson could prove that violations of the trial protocol affected the government payments, the legal case would still fail “because the alleged violations were immaterial to the government’s payment decisions.”

The separate motions to dismiss the case are the focus of the March 1 hearing.

US Wants Case Dismissed

U.S. lawyers backed the companies, filing a statement in support of dismissal.

“While fraud on the Food and Drug Administration or the failure to comply with clinical trial protocols could potentially give rise to False Claims Act liability in an appropriate case, in the instant case the complaint does not plead a sufficient nexus between the alleged clinical trial violations and the alleged requests for payment from the Government to support such liability,” government lawyers wrote.

“The complaint does not plead facts indicating how any express or implied representations in connection with Pfizer’s claims for payment were false or misleading in light of Ventavia’s alleged clinical trial violations,” they added.

The government also said, even if violations occurred, that Ventavia ran a small enough number of sites that fraud wouldn’t have plausibly affected the FDA’s decision to grant emergency use authorization (EUA).

“Even if the allegations were sufficient to show that Ventavia’s safety and efficacy data was unreliable, a conclusion that the criteria for issuance of an EUA would not have been met without the Ventavia data is implausible considering that authorization is based on ‘the totality of scientific evidence available’ and the complaint alleges that Ventavia enrolled only about 3 percent, or approximately 1,500 of the nearly 44,000 total clinical trial participants,” lawyers said.

Jackson Responds

In a reply, Jackson’s team noted that the United States hasn’t filed to dismiss the case. It also asked for an extension multiple times to consider backing Jackson before ultimately choosing against that path.

“The unusual pleading by the United States suggests a split of opinion between the attorneys working the case and the Biden White House,” Jackson’s lawyers said.

The statement was presented in support of the companies but actually supports Jackson’s position that a claim under the False Claims Act (FCA) only requires creating an inference that trial violations could have impacted an FDA decision, the lawyers added.

“The United States claims the inference must be that the violations at the Ventavia site ‘actually’ altered the FDA’s decision, but the FCA pleading standard is not one of actuality but of materiality,” they said. “Whether a false statement is material depends on whether the false statement has a ‘natural tendency to influence, or is capable of influencing, the decision of the decision-making body to which it was addressed.’

“The United States posits ipse dixit that given Ventavia’s clinical trials were ‘only about 3 percent, or approximately 1,500 of the nearly 44,000 total clinical trial participants’ and that was not enough to alter the FDA’s decision to grant EUA,” the reply also said. “This analysis, however, does not track the materiality inquiry given proper inquiry is whether the fraud has the ‘potential to influence the government’s decision.'”

If the case survives the motions to dismiss, then discovery, which has been paused, would move forward. A trial is set for 2024. Jackson already submitted a list of people she would like to depose. The list includes more than 100 people.