A high-profile healthcare lawsuit in Beaumont, Texas, is flying under the radar—which is just how the federal government and Pfizer want it.
The Department of Justice recently argued that a whistleblower lawsuit against Pfizer, filed by Brook Jackson, should be dismissed.
Jackson, a 20-year veteran in clinical trial administration employed by a third-party vendor (Ventavia Research Group), worked on Pfizer’s COVID-19 vaccine trials in 2020. Alarmed by what she witnessed, Jackson raised concerns to her superiors, Pfizer, and the Food and Drug Administration (FDA) in September 2020.
She claimed the trial was being run, documented, and reported in a manner that violated Federal law and was potentially dangerous.
Hours after contacting the FDA on September 25, 2020, Jackson was fired. Her sealed whistleblower complaint seemed to stall, with the FDA not investigating her claims. Faced with inaction, Jackson filed a lawsuit.
As the case progressed towards discovery, the DOJ intervened, asking the judge to dismiss the case. Jackson argues that the government failed to articulate a legitimate reason for dismissal and did not demonstrate why the burdens of continued litigation outweigh its benefits.
Disturbingly, a former FDA lawyer who worked at the agency when Jackson’s complaint was filed has moved to the DOJ and is now representing the government in its attempt to shut down the suit, raising concerns about regulatory capture and the use of government to shield companies from accountability.
In 2021, the British Medical Journal published an article investigating Jackson’s claims and found them credible. The journal’s investigation concluded that Jackson’s account was supported by documentation and raised serious questions about the integrity of Pfizer’s vaccine trials and the FDA’s oversight.
Other former Ventavia employees vouched for Jackson’s complaint, describing a “helter-skelter” work environment and lack of oversight.
Despite evidence and corroboration, the FDA did not inspect Ventavia after Jackson’s complaint, and Pfizer did not mention any problems at Ventavia in its FDA submission for emergency use authorization.
BMJ’s findings lend significant credibility to Jackson’s claims and raise serious questions about the integrity of Pfizer’s vaccine trial data, the adequacy of regulatory oversight, and, ultimately, the approved emergency use authorization.
Should the court grant the DOJ’s request for dismissal, it could send a chilling message to would-be whistleblowers and undermine public trust in the vaccine approval process. The BMJ investigation suggests that Jackson’s concerns deserve a thorough examination, which might only occur if her lawsuit moves forward.
Additionally, the revelation that a former FDA official involved in the vaccine’s approval is now working for the DOJ and arguing for the lawsuit’s dismissal after the FDA appears to have outed Jackson to her employer, ultimately leading to her firing, raises further questions about potential conflicts of interest and regulatory capture.
Despite its significance, the case has received limited media coverage. Reporting on the FDA employee turned DOJ Pfizer bodyguard was an independent Dallas, Texas-based journalist, Texas Lindsay.
In related news, this week AstraZeneca pulled its COVID-19 vaccine from the market.
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