Here’s a smoking gun that the Trump administration, contrary to their many words, are status quo with pharmaceutical megacorps. Of course Trump has his deal with big pharma to get you those toxic medicines cheaper, so he’s actually a promoter. Though, how this woman stayed alive is of interest, and you have to wonder if she’s someone’s asset. Even after blowing the whistle publicly on Boeing, they killed some of those whistleblowers. Then perhaps they knew they had enough control within government and the media to make sure this didn’t become a problem, which has been successful so far.
Fired six hours after she notified the FDA in September 2020 about concern regarding the Phase 3 trials she oversaw in Texas as a regional director for Ventavia, Jackson filed the FCA case in 2021 as a “relator” on behalf of the federal government, arguing Pfizer wrongly secured emergency use authorization and a related massive payout from taxpayers.
https://justthenews.com/politics-policy/health/doj-tries-shut-down-pfizer-clinical-trial-whistleblower-after-fda-admits
Government lawyer ignores leaked memo from FDA vaccines chief as she tries to convince appeals court to block Brook Jackson from refiling her False Claims Act case with new information such as vaccine injury records.
By Greg Piper
Last week, the Food and Drug Administration’s top vaccine regulator told staff that “at least” 10 children died “after and because of” COVID-19 vaccinations and that the agency was preparing to raise the safety hurdles for vaccine approvals.
This week the Department of Justice acted as if that didn’t happen.
DOJ lawyer Nicole Smith didn’t mention the leaked memo from Center for Biologics Evaluation and Research Director Vinay Prasad at an appeals court hearing Wednesday on whether to reinstate a False Claims Act case against Pfizer and a contractor who ran some of its COVID vaccine trials, arguing nothing would change the feds’ minds about Pfizer’s vaccine.
The feds are unabashedly asking for a license to shut down whistle-blowers when regulators are in cahoots with fraudsters, lawyer Warner Mendenhall told the 5th U.S. Circuit Court of Appeals, representing whistle-blower Brook Jackson.
“The government really sort of made our case for us” that DOJ treats the phrase “good cause” in the FCA as authorizing its “mere desire to dismiss” a whistle-blower case to recover federal taxpayer money and share in the refund, Mendenhall said in rebuttal to DOJ’s Smith.
Yet the administration “actually is changing its policies” in real time on vaccines, and there will be “hundreds more deaths in children that the government’s going to recognize” after the 10 cited by Prasad, Mendenhall predicted.
Fired six hours after she notified the FDA in September 2020 about concern regarding the Phase 3 trials she oversaw in Texas as a regional director for Ventavia, Jackson filed the FCA case in 2021 as a “relator” on behalf of the federal government, arguing Pfizer wrongly secured emergency use authorization and a related massive payout from taxpayers.
The Biden administration initially declined to exercise its power to dismiss the qui tam lawsuit in early 2022, then sided with Pfizer several months later by claiming its vaccine would have been approved even if Jackson was right that 3% of trial data were fraudulent, but didn’t actually move to intervene and dismiss until last year.
As it has done repeatedly in less than a year, the second Trump administration stuck with its predecessor’s legal arguments, defending a trial court’s order that dismissed the suit with prejudice so it can’t be refiled, even though a senior Trump DOJ official was simultaneously prosecuting asthma trial fraud.
Warning to whistleblowers: avoid “government complicity”
Chief Judge Jennifer Walker Elrod did nearly all of the questioning at Wednesday’s hearing, which the 5th Circuit itself has not posted as of Thursday but was recorded and posted by Texas medical freedom activist and physician Mary Talley Bowden.
In its combined motion to intervene and dismiss, DOJ first argued it didn’t have to give a specific reason to intervene, then argued for dismissal based on “secondary issues” such as the costs of prosecuting the case, which U.S. District Judge Michael Truncale improperly “confounded” to permanently dismiss the case, Mendenhall told Elrod.
The appeals court must require the feds to prove that her case is truly at odds with “public health policies in the United States,” since the 1986 amendments to the FCA make clear that “relators themselves have this role as a check on a government that may actually be complicit with the defendant” in healthcare fraud, he told Judge Priscilla Richman.
Unlike every previous FCA case cited by DOJ, where the government had good cause to intervene, Jackson’s alleged “facts are extensively supported” by affidavits and documents and DOJ has already recognized her theory as “cognizable” – that inducing the FDA to issue an EUA through fraud violates the law, Mendenhall said.
Its documentation shows “millions of disabled people now due to these COVID-19 shots,” including from the myocarditis flagged by Prasad, “neurological disease or otherwise,” while Pfizer made an initial $1.9 billion for 100 million doses paid for by taxpayers and now $30 billion worldwide, he said.
The government has presented no evidence or analysis to stop Jackson’s suit, or explained its theory that FCA cases are exempt from a provision of the Federal Rules of Civil Procedure on intervention protocol, he said.
The Biden administration blew its chance to invoke its “pretty much unfettered right to dismiss” the suit by waiting until the case was unsealed, and now must face a “much higher bar” for such a late intervention, according to Mendenhall.
Though the case hasn’t moved into legal discovery, it is “unique” because of “a vast army of citizen-researchers and scientists” who spent hundreds if not thousands of hours reviewing Pfizer documents from Freedom of Information Act requests, which confirmed that “more people died in the vaccine arm” than the placebo arm, he said.
Asked why the government isn’t allowed to invoke a political justification to intervene, Mendenhall told Elrod that the feds are suppressing Jackson’s “First Amendment right to access the courts, to vindicate what she learned” in Pfizer’s trials. It “certainly is possible” that bureaucrats “know about the fraud that Pfizer committed,” he said.
If the 5th Circuit lets Jackson refile the case, she “may be able to bring a very different case along the same lines, but with the additional information” to prove fraud, but if not, the message to whistle-blowers is “if fraud involves government complicity, don’t bother reporting it,” Mendenhall said.
“Why is it called ‘good cause'” if you don’t need any reason?
DOJ’s Smith framed the FCA in black-and-white terms and the government’s power to dismiss whistle-blower cases as absolute.
Judge Truncale was right that “the government’s desire to dismiss itself constitutes good cause” because DOJ determined “its interest would not be served” and the defendants haven’t filed an answer, so “the court has no adjudicatory role,” Smith said.
She argued with Judge Elrod over whether FRCP Rule 41 requires trial judges by default to dismiss without prejudice, letting plaintiffs refile their cases, with Smith claiming the rule only assumes dismissals are without prejudice unless otherwise stated.
The 5th Circuit wouldn’t have jurisdiction to review if Jackson could keep refiling and Judge Truncale kept dismissing the case, Smith said.
Elrod wasn’t convinced the record shows the case “would be futile” if Jackson could refile, as Smith insists, since Jackson might be able to “plead it better” and the government might change its public health policy, especially following an election.
The judge questioned whether “the government’s made up its mind” is a legitimate basis to permanently dismiss a whistle-blower case.
Judge Don Willett asked whether “desire alone” is enough for good cause or “must there always be some articulated reason” for dismissal. Smith responded that “the government doesn’t need to convince the court” when it moves to intervene.
“Why is it called ‘good cause’?” Elrod retorted. “That sounds like that’s a standard where you have to reach a certain goal,” but Smith is arguing “it’s just the government’s prerogative.” Elrod asked if Smith was “trying to make some law here in a circuit,” chuckling.
“Whistleblowers have a right to gather information”
Ventavia lawyer, Andrew Guthrie, rebutted Jackson’s claim that the Pfizer contractor knew she had gone to the FDA when it fired her the same day. “If it’s super-duper fast we can say that it could be linked,” Elrod responded, but Guthrie insisted Jackson must show the company knew she was engaged in “protected activity.”
When Elrod questioned whether her firing could be a “coincidence,” Guthrie recounted Ventavia’s “issues” with Jackson in 18 days as an employee. “She was finding confidential materials. She was taking pictures.”
The FCA does not protect “criticizing business practices,” and all Jackson reported internally was “I’m concerned we’re not following a clinical trial protocol” and possibly not following FDA rules, Guthrie said. The FCA does not create “an all-purpose anti-retaliation provision.”
“Is it categorical or is there any scenario where a quality control complaint in a clinical trial could constitute FCA protected activity?” Willett asked. Only if Jackson had explicitly said Ventavia was defrauding the government through its trial protocol, Guthrie said.
Whistleblowers aren’t required to say the exact right words to bring cases, Mendenhall said in rebuttal. “They have no idea” what the FCA is or what “qui tam” means, but Jackson saw her employer lying in a clinical trial, to Pfizer and the FDA, “and suppressing the information about those lies with this relator,” which “messes up the entire data set” from the trial.
The FRCP requires the court to read all inferences in Jackson’s favor, and given that “there was no disciplinary action before that day” when Ventavia blindsided her with accusations of violating federal health privacy law, the judges should interpret its actions as “papering the file,” Mendenhall said. “Whistle-blowers have a right to gather information.”