The Department of Justice is aggressively trying to shut down Pfizer whistleblower Relator Brook Jackson, even as internal FDA communications now admit that children died “after and because of” the COVID-19 shots.
Last week, the FDA’s top vaccine regulator quietly told staff that “at least” ten children were killed by the injections, and the agency was preparing to raise its safety thresholds for new vaccine approvals, Just the News reported.
This week, instead of addressing the catastrophic implications of that revelation, the DOJ marched into court to argue the opposite: that nothing, not even evidence of dead children, would change the federal government’s unwavering loyalty to Pfizer.
According to Dr. Mary Talley Bowden, “In the appellate hearing for United States ex rel. Jackson v. Ventavia Research Group, LLC, whistleblower Brook Jackson challenged the district court’s decision to allow the U.S. government to intervene and dismiss her qui tam lawsuit under the False Claims Act (FCA).”
Filed in 2021, whistleblower and clinical research auditor Brook Jackson alleges that Pfizer, its subcontractor Ventavia Research Group, and international clinical research giant ICON PLC falsified clinical trial data, violated FDA regulations, endangered patient safety, and defrauded the U.S. government in their chaotic rush to deliver the first COVID-19 vaccine under Operation Warp Speed.
The explosive 81-page False Claims Act complaint, filed in the Eastern District of Texas, lays out a pattern of misconduct Jackson says she witnessed “on an almost daily basis” during her short tenure overseeing Pfizer’s Phase 3 trial sites managed by Ventavia.
According to the complaint, Pfizer pushed Ventavia to enroll as many subjects as fast as possible, creating rampant protocol violations, falsified data, unblinded staff, safety breaches, HIPAA violations, and sloppy or fabricated documentation that was later fed into the clinical trial database used to secure FDA authorization.
Brook Jackson, a clinical-research professional with 18 years’ experience, served as a regional director overseeing Pfizer’s Phase 3 vaccine trials in Texas.
According to the federal complaint, Jackson discovered:
Fabricated or falsified patient data, including altered vital signs, missing signatures, and invented blood-draw information.
Ineligible trial subjects injected anyway, including pregnant women and staff family members prohibited by protocol.
Unblinded staff, with vaccine packaging and randomization materials left in open view—an error that legally requires the site to halt injections immediately.
Temperature-control failures for the ultra-cold Pfizer product, with no reporting of required “temperature excursions” to Pfizer.
Unqualified personnel administering injections, including individuals not listed on delegation logs.
Failure to monitor patients for adverse events, including skipping the required 30-minute observation window.
Sloppy or fraudulent “quality checks”, where staff allegedly filled in missing data long after the fact—and sometimes simply made it up.
Serious safety events not being reported to Pfizer within 24 hours, as federal regulations require.
The complaint states that Pfizer had a direct financial incentive to overlook misconduct: the company stood to receive $1.95 billion from the Department of Defense for the first 100 million doses, with options to sell hundreds of millions more.
By December 2020, DoD exercised that option—bringing Pfizer’s total payout to $3.9 billion.
The lawsuit accuses Pfizer and its contractors of:
Submitting false claims for payment under a DoD contract
Falsifying or concealing clinical-trial data
Retaliating against a whistleblower
Violating FDA regulations, federal law, and Good Clinical Practice
Endangering patient safety
On the morning of September 25, 2020, she called the FDA hotline.
She was fired that same day. Ventavia claimed she was “not a good fit.” No corrective action was taken on the misconduct she reported.
Representing Jackson, attorney Warner Mendenhall told the court that DOJ’s argument proves exactly why the case must move forward:
“The government really sort of made our case for us…”
DOJ treats “good cause” as permission for its “mere desire” to dismiss a whistle-blower case.
Mendenhall warned that the FDA’s own internal shift on safety, after admitting child deaths, means that “hundreds more deaths in children that the government’s going to recognize.”
When Jackson filed her lawsuit in 2021, the Biden administration initially said it would NOT dismiss it.
But after several months, and after aligning itself with Pfizer’s position, the Biden DOJ reversed course and claimed:
Even if 3% of trial data were fraudulent,
Even if Pfizer misled regulators,
Even if Jackson was correct on every point… the vaccine still would have been approved.
According to Just the News, attorneys under the second Trump administration continued defending the Biden-era position, “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.”
At the appeals hearing Wednesday, DOJ attorney Nicole Smith refused to acknowledge the leaked memo from FDA Center for Biologics Evaluation and Research Director Vinay Prasad, who told staff the agency will now be forced to raise safety hurdles for future vaccine approvals.
More from Dr. Bowden:
Jackson’s attorney, Warner Mendenhall, argued that the government’s intervention lacked “good cause” as required by FCA provisions. He contended that the government’s mere “desire to dismiss” was insufficient, especially post-seal when the case had progressed. Mendenhall emphasized that Congress designed the FCA to empower relators like Jackson as checks against potential government complicity in fraud. He cited the 1986 FCA amendments, which prioritize combating fraud in federal healthcare programs and protect whistleblowers from dismissal without rigorous scrutiny. The district court, he claimed, erroneously conflated the motion to intervene with the motion to dismiss, ignoring Federal Rule of Civil Procedure 24’s requirement to consider prejudice to original parties.
Mendenhall highlighted evidentiary support for Jackson’s claims, including affidavits and documents showing more deaths in the vaccine arm than placebo, and criticized the government’s lack of investigation details. He argued for remand to force the government to demonstrate good cause, potentially tied to shifting public health policies amid emerging vaccine injury data. On dismissal, he advocated for “without prejudice” under Rule 41, allowing refiling with new evidence, as Jackson had not previously dismissed the case. He warned that prejudice would eviscerate whistleblower protections, signaling that reports involving government complicity are futile.
The government’s attorney, Sarah Smith, argued that the government’s own decision to end the case is, by itself, a sufficient legal reason to allow it to intervene and dismiss the lawsuit. She relied on a Supreme Court ruling in Polansky v. Executive Health Resources to support this position.
Smith explained that when the government seeks dismissal before the defendants have filed a formal answer, the court has no authority to second-guess or block that request under the normal rules for voluntary dismissal (Rule 41(a)). In such situations, the judge must grant the dismissal.
She further maintained that dismissing the case with prejudice (meaning Brook Jackson could not refile it) was proper because it would prevent repeated, pointless attempts to bring the same claim again. She pointed out that Jackson had already filed two amended versions of her complaint, and the government had concluded that continuing the case would not serve its interests—regardless of whether that conclusion was based on cost, policy changes, or other considerations. Her core argument was that qui tam lawsuits under the False Claims Act are brought on behalf of the United States, so when the government decides the case should not go forward, the court should respect that decision and close the matter permanently.
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