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VIVA FREI & BARNES đ BROOK JACKSON WHISTLEBLOWER LAWSUIT ALLEGATIONS AGAINST VENTAVIA PFIZER &am
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Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract
Citizen Wells
Jul 10, 2022
Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract
From the Defender.
âPfizer Asks Court to Dismiss Whistleblower Lawsuit Because Government Was Aware of Fraud
In an interview with The Defender, the lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jacksonâs lawsuit alleging fraud in Pfizerâs COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker.
A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizerâs COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.
In an interview with The Defender, Jacksonâs lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker.
A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizerâs COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.
In an interview with The Defender, Jacksonâs lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker.
Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government.
However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as âmaterialityâ resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed.
As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractorâs fraudulent activity, the fraud was not considered âmaterialâ to the contract.
Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus.
âPfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud,â attorney Robert Barnes said.â
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Allegations and observations of Brook Jackson.
4. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (âIconâ), an Irish clinical research organization. Icon was tasked with oversight of over 160 test sites worldwide, ensuring trial protocol compliance, and ensuring reporting of required information. This includes oversight of Serious Adverse Event (âSAEâ) reporting, which is required by the trial protocol and federal regulations. Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trialâs protocol.
5. Defendant Ventavia Research Group, LLC (âVentaviaâ) was contracted by Pfizer to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. Ventavia ultimately enrolled about 1,500 clinical trial patients. Ventavia employed Relator Jackson as a Regional Director. She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites.
6. Pfizer, aiming for the title of âfirst successful COVID-19 vaccine,â pushed Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. Ventavia was compensated by Pfizer mainly on a per-patient basisâup to a weekly limitâand rushed to enroll as many clinical trial participants as possible per week. Ventaviaâs race to maximize payment and over-booking of patients resulted in sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight. Pfizer and Icon turned a blind eye to Ventaviaâs misconduct, despite numerous warning signs.
7. Ventaviaâs trial protocol and regulatory violations were so widespread, in fact, that Relator observed them on a near-daily basis during her brief employment period. For example,
Relator observed:
âą fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data;
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