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Brook Jackson, a former employee of the Ventavia Research Group — which conducted some of the clinical trials for the Pfizer-BioNTech COVID-19 vaccine — in January 2021 sued Pfizer, Ventavia and ICON PLC, another Pfizer contractor, alleging the companies committed numerous violations of the False Claims Act (FCA) during the clinical trials.
According to Jackson’s complaint, the three companies “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question,” and as a result, they defrauded the U.S. government which purchased the vaccines.
The FCA allows the government or a party suing on its behalf, such as Jackson, to attempt to recover money for false claims made by parties in order to secure payment from the government.
Those parties can be held liable under the FCA if they knowingly made a false claim or used a false record or statement in order to secure payment.
Also under the FCA, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government.
In February 2022, the federal government declined to intervene in the lawsuit on Jackson’s behalf.
In his March 31 ruling, U.S. District Judge Michael Truncale of the U.S. District Court for the Eastern District of Texas-Beaumont Division ruled Jackson had not proved the companies violated the FCA.
However, in a footnote accompanying his decision, Judge Truncale left the door open for Jackson and her legal team to file an appeal, stating:
“The Court observes, however, that while Ms. Jackson has failed to state a claim for retaliation under the FCA, she may be able to bring her claim under another statute.
“The Court does not opine on the likelihood of success with respect to asserting retaliation under a different statute.”
In a statement posted on Twitter, Jackson sharply criticized Truncale’s ruling, writing:
“The dismissal of Pfizer’s case is a despicable & heinous betrayal of justice, a slap in the face to vaccine injured and whistleblowers, a blatant example of corruption, incompetence and cowardice, a declaration that the powerful are above the law.”
Jackson also tweeted:
I filed this case on behalf of the American people because our tax dollars were used to fund Pfizer’s killer shot. Now, I must apologize to the world on behalf of the United States of America. @pfizer @VRG_FortWorth @ICONplc It’s not over! By a long shot. #forthevictims https://t.co/IQII42kCUN
— Brook Jackson 💜 (@IamBrookJackson) March 31, 2023
A blueprint for federal contractors to commit fraud and get away with it?
Jackson, who had over 15 years of experience working with clinical trials, claimed she “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 in September 2020.
She also gave The BMJ a cache of internal company documents, photos and recordings highlighting alleged wrongdoing by Ventavia.
The documents Jackson provided contained evidence of 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.
According to The Epoch Times, the federal government’s agreement with Pfizer set, as its only condition of payment, delivery of a vaccine that was authorized or approved by the U.S. Food and Drug Administration (FDA).
As Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine has not been withdrawn, the federal government’s agreement with Pfizer remains valid, according to Judge Truncale, who wrote:
“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.
“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. Pfizer was entitled to its claims for payment. Therefore, Ms. Jackson has not stated a claim for false record liability.”
Jackson described Judge Truncale’s decision as a “blueprint” on how government contractors can “commit fraud and get away with it. She and her lawyers said they will appeal the dismissal.
— Brook Jackson 💜 (@IamBrookJackson) April 1, 2023
Judge: FCA not created to ‘second-guess’ federal policymakers
Judge Truncale said the FCA places the onus on the federal government to determine whether it had been defrauded.
He quoted another ruling finding that the FCA was not created to “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,” that ruling went on to state.
This very argument was put forward by Pfizer during the case. As quoted by The Epoch Times, Judge Truncale asked the defense, “So if the FDA gets it wrong, they just get it wrong, and we live with it?”
To this, Pfizer attorney Carlton Wessel replied, “Exactly.”
Judge Truncale noted that the federal government has been aware of Jackson’s claims “for several years,” but despite this, granted an EUA “multiple times” and “continues to authorize and provide Pfizer’s vaccine at no cost.”
He also noted that Jackson’s complaint did not “identify any safety risk that was hidden from the FDA.”
A 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as “materiality” resulted in a series of federal court decisions in which fraud cases brought under the FCA were dismissed.
As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractor’s fraudulent activity, the fraud was not considered “material” to the contract.
The FCA also allows whistleblowers to file claims on the basis of harassment, retaliation and threats if they are engaged in a “protected activity,” defined as being “motivated by a concern regarding fraud against the government.”
It is this aspect of Jackson’s claim that will be allowed to proceed on appeal.
Ventavia hired Jackson in September 2020. She reported problems she observed with the Pfizer vaccine trial to the company’s management that same month. When management didn’t respond, she took her claims to the FDA on Sept. 25, 2020. Ventavia fired her that same day.
Judge Truncale ruled that Jackson had not engaged in protected activity under the standard set by the FCA, but left open the possibility that she could file a retaliation claim under a different statute.
Pfizer previously was heavily fined in connection with the FCA. As part of a 2009 settlement, the company paid $2.3 billion in fines — the largest healthcare fraud settlement in the history of the U.S. Department of Justice — stemming from allegations of illegal marketing of off-label products not approved by the FDA.
In an attempt to strengthen the FCA’s anti-retaliation provisions and install new safeguards against industry-level blacklisting of whistleblowers seeking employment, Congress in July 2021 introduced the False Claims Amendments Act of 2021.
A new bill, the Administrative False Claims Act of 2023 (S.659), was filed as part of the current Congressional session, sponsored by Sen. Chuck Grassley (R-Iowa), who also sponsored the 2021 version of the bill.
This version of the bill passed the Senate via unanimous consent on March 30. It remains pending before the U.S. House of Representatives. However, its provisions are significantly more limited than the 2021 version of the bill, raising “the maximum amount of a fraud claim that may be handled administratively from $150,000 to $1 million.”
By contrast, the 2021 version of the bill stated:
“In determining materiality, the decision of the Government to forgo a refund or to pay a claim despite actual knowledge of fraud or falsity shall not be considered dispositive if other reasons exist for the decision of the Government with respect to such refund or payment.”
This language appears to be missing from the 2023 version of the bill.
It is not known if Judge Truncale issued his decision on March 31 in anticipation of the bill passing the House and potentially becoming law.