Background

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)

• Ventavia staff were not following the patient informed consent procedure
• Required signatures were not being obtained and sometimes being forged
• Vaccines were not being stored under the specified low temperature conditions
• A dominant culture of sloppiness, rushing the work and falsifying records existed in the company
• Adverse events were not being properly recorded

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).

Significance

First legal challenge in USA of Pfizers product safety and efficacy claims

Plaintiff’s Argument

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)

Relevant Prior Judgements/ Cases

…More information is needed…

Decision

This case is ongoing

Aftermath

This case is ongoing 

Further Research

Court Documents:

• Read the Court Filing

In the news:

• Epoch Times Report – Aug 25 2022

Media

Keyword

Brook Jackson, Clinical Trials, False Claims Act, Mendenhall, Pfizer, Safety, Vaccine, Ventavia, Whistleblower