Pfizer False Claims Case
Re: the Legality of Making False Safety & Efficacy Claims of the Pfizer Covid Injection
Facts of the Case
*updated Aug 31, 2022
Brook Jackson is a Clinical Research Auditor turned whistleblower who worked for Ventavia company (a contractor for Pfizer) on the phase III clinical trial of Pfizer Covid-19 vaccine.
Jackson commenced her employment with Ventavia on 8th September 2020 as a Regional Director, supervising two of three trial sites involved in the clinical. Immediately after starting her work she observed several glaring quality outages in the way the trials were being performed, including the following:
– all trial participants had been unblinded from July to September 2020 in the in the randomised double blind trials, thus invalidating the protocol (1)
Brook explains that when the unblinding error was discovered, Ventavia staff were asked to remove the evidence and lie to Pfizer about the unblinding.
Brook subsequently shared all her findings with Ventavia expecting that they would take corrective action. However since there was no action, she anonymously reported her findings to Pfizer, again without results. Finally on the morning of 25th September she informed the FDA.
I took it to a regulatory authority that I believed and trusted … was there to protect patient safety and look at the big picture.
Ventavia fired her 6 hours later giving as the only reason that she was not a good fit with the company.
Her lawyer, Warner Mendenhall said of her termination: This is really remarkable that the Federal government apparently has reached out to Pfizer and revealed / unblinded the whistleblower who has come forward. I mean, we actually do have a process to blind and protect whistleblowers in the country for a reason. Its so that this stuff can come forward and the information be shared with the Federal government and collected. . When I first started in the 90s I felt like the federal government was very protective of whistle blowers to preserve their anonymity and now, recently, I see the Federal government reaching out , in two instances recently, and unblinding the whistle blower which causes them to be fired and lose the capacity to continue to investigate. (2)
Even after being fired, Jackson had expected that following her whistleblowing action would at least result in an inspection of the Ventavia site by FDA auditors. However, after three months waiting for this without any action from the FDA, Jackson decided to file a false claims lawsuit against Pfizer and its associates Ventavia and ICON (3)
The lawsuit (4) was filed in Texas on Jan 8 2021. It was held under seal for 60 days during which Jackson could not talk publicly about the lawsuit. Jackson has actually said that she has been prevented from talking about the filing for a year (5).
First legal challenge in USA of Pfizers product safety and efficacy claims
Brook Jackson argues that Pfizer and its associates involved in the clinical trials are in breach of the False Claims Act because they knowingly brought the Covid-19 vaccine onto the market while making safety claims which could not be supported based on Jacksons observation of quality outages in the running of the clinical trials.
Pfizer, Ventavia and ICON have argued that the case should be dismissed because the government already knew about the fraud based on Jacksons whistleblowing actions. Therefore, they argue, a legal action under the False Claims Act is not supportable or appropriate. (5)
…More information is needed…
This case is ongoing
This case is ongoing
Brook Jackson, Clinical Trials, False Claims Act, Mendenhall, Pfizer, Safety, Vaccine, Ventavia, Whistleblower