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The U.S. Department of Justice (DOJ) on Tuesday asked to intervene in a lawsuit alleging Pfizer committed fraud during clinical trials for the Pfizer-BioNTech COVID-19 vaccine.
The DOJ simultaneously asked the court to dismiss the lawsuit, which was filed by whistleblower Brook Jackson, against Pfizer.
“The United States should not be required to expend resources on a case that is inconsistent with its public health policy,” the DOJ said in its motion to dismiss.
Jackson told The Defender the DOJ’s motion was “expected” and “will clarify the standards for good cause being applied” regarding the U.S. government’s justification for “allowing Pfizer to commit fraud on the U.S. Food and Drug Administration” (FDA).
“This fraud has undoubtedly cost American taxpayers billions of dollars and has led to an untold number of injuries from the COVID-19 countermeasure, including permanent disability and death among my fellow citizens,” Jackson said.
Jackson is a former employee of the Ventavia Research Group, an independent lab that conducted some of the clinical trials for the Pfizer-BioNTech COVID-19 vaccine.
In January 2021, she sued Pfizer, Ventavia and ICON plc, another Pfizer contractor, alleging the companies committed numerous violations of the False Claims Act during the trials.
In September 2022, Jackson filed an amended complaint, which was dismissed in April 2023. She subsequently filed a second amended complaint in October 2023, prompting the DOJ to claim it “has good cause to intervene and is entitled to dismissal” of the case.
Oral arguments in the case are scheduled for April 17 before the U.S. District Court for the Eastern District of Texas Beaumont Division.
Sasha Latypova, a former pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development, told The Defender, “The case alleges that Pfizer committed fraud in order to get the contract for COVID-19 vaccines from the U.S. government while knowingly delivering a defective product.”
“The fraud that Jackson describes … has not been disputed by Pfizer,” Latypova said.
Robert Barnes, one of the lawyers representing Jackson, spoke at a March 8 presentation of the Vaccine Safety Research Foundation, where he said, “Any and every form of fraud they could commit, they did,” referring to Pfizer.
“[Jackson] discovered it, uncovered it and went through the appropriate internal review protocols and assumed that people would correct the defects,” Barnes said. “And instead of that occurring, she was summarily fired.”
‘Pfizer lied in order to get paid’
The DOJ’s motion to dismiss states that Jackson “alleged that defendants violated the protocol for the Pfizer-BioNTech COVID-19 vaccine clinical trial at three study sites in Texas and that defendant Pfizer misrepresented the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine to the Food and Drug Administration (FDA).”
Jackson filed her lawsuit under the False Claims Act, which 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 an attempt to secure payment from the government.
Those parties, such as Pfizer-BioNTech, can be held liable under the act if they knowingly made a false claim or used a false record or statement to secure payment.
According to the DOJ’s filing, the False Claims Act “requires the United States to notify the court whether it will intervene in the qui tam action or decline to take over the action,” following “a period of investigation.” A qui tam action refers to any legal case where a private citizen initiates legal action on behalf of a state.
The government may choose whether to intervene in qui tam cases. If it does, it may then proceed with the lawsuit instead of the citizen who originally filed the claim — known as a “relator.”
The government may subsequently opt to settle the case or to file a motion to dismiss, which the DOJ did.
The DOJ claims the U.S. “has good cause to intervene for the purpose of dismissal” based on U.S. Supreme Court precedent in a June 2023 ruling, United States ex rel. Polansky v. Executive Health Resources Inc., et al., that said the government may intervene and move to dismiss a False Claims Act case at any time in the life of the case.
The DOJ further claimed that the U.S. government has good cause to intervene in the case because it has access to the same clinical trial data, adverse event data and other scientific research Jackson refers to in her complaint.
To support the DOJ’s claims, the motion cites a Jan. 5, 2024, JAMA editorial authored by FDA Commissioner Robert Califf and the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, claiming that:
“Contrary to a wealth of misinformation available on social media and the internet, data from various studies indicate that since the beginning of the COVID-19 pandemic tens of millions of lives were saved by vaccination.”
The DOJ also argued that, if the case is allowed to continue, the discovery process and ongoing legal proceedings “will impose a significant burden on FDA, HHS [U.S. Department of Health and Human Services], and DOJ.”
Referring to the Supreme Court’s Polansky ruling, Jackson said:
“The government came in at the very last moment and did what they’re doing in this case, trying to get rid of it.
“So, it went all the way to the Supreme Court and the Supreme Court ruled that based on the False Claims Act, the government has the ultimate authority to do whatever it wants to do in a sense. But again, having to show … good cause.”
Latypova said that once a case is filed under the False Claims Act, “it immediately goes under seal for an initial 60 days.” After this, “The government has 60 days to decide whether to intervene in the case or not. They could have intervened and dismissed or they could have declined to intervene and not dismiss.”
According to Jackson, “In February 2022, after keeping the case sealed and investigating the allegations for nearly 14 months, the government chose not to intervene but did not move to dismiss either. The case was then unsealed, allowing me to proceed with the action on my own, acting on behalf of the U.S.”
“The Justice Department waited until the last minute before the first round of dismissal hearings before the judge, and they made a very rare intervention, but not a full intervention,” Barnes said. “They attempted that and it partially worked,” he added, referring to the initial April 2023 dismissal of Jackson’s lawsuit.
Barnes added:
“We succeeded in getting the judge to reconsider his ruling, and he reinstated the fraud and the inducement claim, because that’s what the claim is fundamentally about — that Pfizer lied in order to get paid. They lied about what they were delivering. They said what they were delivering was safe. It wasn’t.”
Barnes said that under the U.S. government’s contract with Pfizer, the U.S. was “not paying for a therapeutic, they were not paying for a diagnostic, they were paying for something that would inoculate. And of course, this never did.”
According to Latypova, by waiting until now to file a motion to intervene, based on the Polansky ruling, the government opted to wait until “after they had an opportunity to get as many shots in as many arms as they possibly could.”
“This is the second time the DOJ is planning to intervene and to ask the court to dismiss the second amended complaint from Brook,” Latypova said. “This clearly points to the U.S. government’s desire to not investigate the clinical trial fraud for COVID-19 vaccines,” she said.
Jackson said the DOJ still must show good cause, noting that a motion to dismiss “must be done in good faith and they must provide good cause — this is key, and why I am confident that these motions will be denied,” she said.
“The government must show … why they have a reasonable argument that it is more likely than not that the downsides to the case exceed the upsides,” Barnes said. “In a multi-billion-dollar case, what’s that argument going to be from the Justice Department?”
Discovery could show government covered up vaccine adverse events
If the DOJ’s motion to dismiss fails, the process of discovery will proceed and that may reveal more evidence of a possible government cover-up.
“We believe discovery will show the government wasn’t conducting any meaningful investigation at all,” Barnes said. “It was lying to Brook Jackson, it was lying to her counsel, and more importantly, to a certain degree, it was lying to the court.”
“What was really occurring all along is that the Justice Department was deliberately slow-rolling the case for the benefit of Pfizer,” Barnes added.
“We’re going to ask to potentially receive some discovery in what that 14 months of government investigation looked like and why they chose to keep it under seal so long and at that point, dismiss … We want to know why,” Jackson said.
As for what discovery may reveal, Latypova said she is “quite certain” that “it would confirm all allegations of fraud that have been observed by Brook — violations of the clinical trial protocol, unblinding, lack of proper informed consent, manipulation of data, hiding adverse events from the vaccines, and more.”
“I hope that the discovery would also produce unredacted contracts between the Department of Defense and Pfizer,” Latypova added.
The opportunity to file a second amended complaint also allowed more evidence to be incorporated into the case, Jackson said, as the previous complaint only allowed her to “claim what I knew as of September 2020.”
“We found out more about the approval process through the FDA’s release of the clinical trial documents. As more people came forward, as science evolved, we learned more,” Jackson said.
According to Latypova, this new information includes preclinical studies from Pfizer and Moderna, human adverse event data from the Vaccine Adverse Event Reporting System (VAERS) and other databases, and “reports and published studies from thousands of physicians and injured people.”
“The data is overwhelming, showing severe damage caused by these products,” Latypova said. “The documentation also demonstrates that the manufacturers knew that the product is extremely dangerous … Yet, they lied about the product’s safety, efficacy and manufacturing quality and took billions of dollars in taxpayers’ money.”
According to Barnes, constitutional issues will also be at play if the lawsuit proceeds. This includes “whether or not impermissible First Amendment issues are motivating the Justice Department in pursuing this case, a case that might embarrass the current administration that was in bed with Pfizer as to this vaccine.”
“It’s been four years of fighting a system that I thought was on our side,” Jackson said. “We’ve lost sight of what, or rather who, the government serves. It’s the people.”
“I’ll remind the powers-that-be in Washington once again that according to the U.S. Constitution, the government’s job is to protect and serve the people. We are the sole interest, and we demand vindication.”
