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Whistleblower Will Appeal After Federal Court Dismisses Lawsuit Alleging Fraud in Pfizer COVID Vaccine Trials

By Michael Nevradakis, Ph.D. | The Defender | August 13, 2024

For the second time, a federal court in Texas has dismissed a whistleblower lawsuit alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during clinical trials for the Pfizer-BioNTech COVID-19 vaccine in 2020.

In his Aug. 9 ruling, District Judge Michael J. Truncale sided with the U.S. government, ruling the government had demonstrated “good cause” to intervene and dismiss the case. He wrote:

“The Government’s desire to dismiss the case — because of its doubt as to the case’s merits, differing assessment of the Pfizer vaccine data, desire to avoid discovery and litigation obligations, and belief that it should not have to expend resources in a case that is contrary to its public health policy — constitutes good cause to intervene.”

Whistleblower Brook Jackson filed the lawsuit against Pfizer, Ventavia Research Group — which conducted some of the clinical trials for Pfizer’s COVID-19 vaccine — and Pfizer contractor ICON PLC in January 2021. Jackson’s complaint was most recently amended in October 2023.

Jackson, a former Ventavia employee, alleged the companies committed numerous violations of the False Claims Act (FCA) during the clinical trials.

According to the lawsuit, the three companies “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question,” thus defrauding the federal government, which purchased the vaccines.

The FCA allows the government or a party suing on its behalf to attempt to recover money for false claims made by parties to secure payment from the government.

The FCA also allows whistleblowers to be rewarded for confidentially disclosing fraud that results in a financial loss to the government.

While whistleblowers have the right to sue under the FCA, the federal government can choose to intervene in the case at a later date. In Jackson’s lawsuit, the U.S. government initially declined to intervene in February 2022. However, in March, the government filed a motion to intervene and to dismiss the case.

Attorney Warner Mendenhall, one of the lawyers representing Jackson, questioned whether the U.S. government’s “public health policy” is tolerant toward allegations of fraud during clinical trials for vaccines.

In an interview Monday with Sasha Latypova, a former pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development, Mendenhall said:

“What’s the public health policy of the United States? To kill people and damage people and injure people and make them sick? If that’s the public health policy, well then yes, we’re inconsistent with that.”

Latypova told The Defender she was “not really surprised” by the ruling, noting that drugmakers enjoy legal immunity afforded by emergency use authorization granted by the U.S. Food and Drug Administration (FDA). Latypova described this immunity as a “legal cage.”

She said “The court took as evidence an unsubstantiated opinion of two government bureaucrats … published in an editorial article of a medical journal,” but did not consider the extensive evidence of wrongdoing Jackson provided.

The government’s motion to dismiss cited a Jan. 5 JAMA editorial authored by FDA Commissioner Robert Califf and the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, claiming that “data from various studies” show that “tens of millions of lives were saved by vaccination.”

During his interview with Latypova, Mendenhall argued the government failed to demonstrate good cause and that last week’s ruling did not name any specific examples of this. He said:

“If you read the actual document, there’s no cause listed at all. In fact, the judge has a footnote saying, ‘There is no cause here, but I’m going to look at this other motion I think I can find’ … that’s not how courts are supposed to proceed. You look at the motion first to intervene for good cause. If it’s not there, you’re done. You don’t get to go on and look at the motion to dismiss for hints that maybe there is good cause.”

The ruling also stated that Jackson “failed to allege that she complained to Ventavia or the FDA about fraud against the government.” Accordingly, her claims don’t “rise to the level of protected activity” as a whistleblower.

Mendenhall told Latypova this poses “constitutional concerns” and may have “a chilling effect on other whistleblowers.”

Jackson has 30 days to appeal the ruling, and plans to, Mendenhall said.

“I am very confident we’re going to win that case and get, at least, the retaliation [claim] vindicated, and vindicate what she did as a conscientious citizen of the United States,” Mendenhall said.

Jackson fired within six hours of submitting claims to the FDA

Ventavia, which operated several sites where it conducted clinical trials on behalf of Pfizer, hired Jackson in September 2020.

That same month, Jackson reported problems she observed with the Pfizer vaccine trial to the company’s management. When management didn’t respond, she took her claims to the FDA on Sept. 25, 2020. Ventavia fired her later that day.

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.”

She also gave The BMJ a cache of internal company documents, photos and recordings highlighting alleged wrongdoing by Ventavia.

“Her job was to fix things. They wouldn’t fix them. She reported it to the FDA, and six hours later was fired from her job,” Mendenhall said.

He added:

“There was not informed consent. They were making up records. I mean, it was just endless. They were violating patient privacy, which is critical in a clinical trial because you have to not know who’s getting the shot in order to determine any effectiveness.

“Basically, the allegations that she brought forward show that the clinical trial that she saw, what she saw of it, was essentially worthless. It wasn’t valuable or useful data.”

Jackson filed her qui tam lawsuit under the FCA in January 2021. A qui tam action refers to any legal case where a private citizen initiates legal action on behalf of a state.

Documents released in November 2021 supported Jackson’s claims that she was directly involved in the Phase 3 trials for the Pfizer-BioNTech COVID-19 vaccine.

‘Level of ignorance’ of scientific facts by government officials ‘astounding’

In February 2022, the federal government declined to intervene in the lawsuit on Jackson’s behalf but reserved the right to intervene at a later date.

Later that month, Jackson filed her first amended complaint, while the court unsealed 400 pages of exhibits.

In July 2022, Pfizer asked the court to dismiss Jackson’s lawsuit on the basis that the U.S. government was aware of wrongdoings in the clinical trials but continued to do business with the vaccine maker. In March 2023, Truncale granted the motion to dismiss, ruling that Jackson had not proved the companies violated the FCA.

Jackson appealed the dismissal in April 2023, and in August 2023 submitted a motion to file a second amended complaint, which was granted in September. Jackson filed her second amended complaint in October 2023.

Pfizer and Ventavia filed motions to dismiss the second amended complaint later in October 2023, while the U.S. government filed its motion to intervene and dismiss in March 2024. Oral arguments discussing the motions to dismiss took place on May 1.

“What happened in the interim here while we’re fighting the case and moving forward, apparently the government itself decided that what we were doing in exposing Pfizer and Ventavia and ICON, the three companies involved here, was contrary to the public health policy in the United States,” Mendenhall said.

In ruling in favor of the government, the court cited a 2023 U.S. Supreme Court decision that gave the government significant leeway concerning when it could intervene in an FCA case and on what basis.

According to Mendenhall, this occurred despite meetings Jackson and her legal team had last year with representatives of the U.S. Department of Justice (DOJ), during which he said they “were completely unaware” of evidence questioning the safety of the COVID shots, including SV40 DNA contamination and vaccine injuries.

Mendenhall said:

“The level of ignorance about the scientific facts that we have uncovered was astounding to me, for someone who is supposed to be in charge of a major decision on behalf of the United States’ people, whether these shots need to be pulled from the market, whether Pfizer needs to be prosecuted or at least held civilly liable along with the other companies.

“I think that, certainly for some in the government, they just don’t want to face what they’ve actually done … they have hurt, damaged the health of millions of Americans and tens of millions, at least, around the world.”

According to Mendenhall, government attorneys were “actually sitting on the side of the courtroom with Pfizer” attorneys during the May 1 hearing.

“How strange that was to have the defendants sitting with the government who’s supposed to be going after them,” Mendenhall said.

In April, Pfizer submitted a statement to the court in support of the U.S. government’s motion to intervene and dismiss.

Pfizer previously was 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 DOJ — stemming from allegations of illegal marketing of off-label products not approved by the FDA.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

August 16, 2024 Posted by | Deception, Science and Pseudo-Science | , , , | Leave a comment