The legal case brought by a whistleblower from Pfizer’s COVID-19 vaccine trial has been dismissed by a judge.
Brook Jackson, who worked for Pfizer contractor Ventavia Research Group, didn’t prove violations of the False Claims Act, U.S. District Judge Michael Truncale ruled on March 31.
Under the False Claims Act, the government or a party suing on the government’s behalf—Jackson in this case—can recover money for false claims made by parties to secure payment for the government. Parties are liable if they knowingly present a false claim for payment or intentionally use a false record or statement material to make a false claim.
While Jackson presented evidence that violations occurred, the government’s prototype agreement with Pfizer only conditioned payment on delivery of a vaccine that had been authorized or approved by the U.S. Food and Drug Administration (FDA), Truncale ruled. The payment section states that “the Government will have no right to withhold payment in respect of any delivered doses, unless the FDA has withdrawn approval or authorization of the vaccine.” The FDA, which Jackson alerted to the violations, hasn’t withdrawn approval or authorization.
“In sum, Ms. Jackson has failed to plead that the Government conditioned payment on Defendants’ certification of compliance with regulatory provisions or clinical trial protocol,” Truncale said in the new ruling.
While Jackson argued that the false record portion of the False Claims Act (FCA) was violated because of the trial violations, the defendants said false records and statements alone didn’t create liability without a false claim seeking payment from the government.
“The upshot is that there is no liability under the FCA for making or using a false record or statement where the claimant is entitled to the payment,” Truncale said. “Pfizer was entitled to its claims for payment. Therefore, Ms. Jackson has not stated a claim for false record liability.”
The judge quoted a different ruling, which found that the False Claims Act was enacted by Congress “to vindicate fraud on the federal government, not second guess decisions made by those empowered through the democratic process to shape public policy.”
“When the government, at appropriate levels, repeatedly concludes that it has not been defrauded, it is not forgiving a found fraud—rather, it is concluding that there was no fraud at all,” the ruling reads.
“The Government has been aware of Ms. Jackson’s allegations for several years, has granted Emergency Authorization multiple times, and to this day continues to authorize and provide Pfizer’s vaccine at no cost,” the judge said in the new ruling.
He acknowledged the evidence that Jackson offered but said her complaint didn’t “identify any safety risk that was hidden from the FDA in the data from the Ventavia sites, any symptomatic participants who Ventavia did not properly test for COVID-19 infection, or any COVID-19 infections in vaccinated participants that Ventavia falsely reported to have occurred in the placebo group.”