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.
“Pfizer 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 Jackson’s lawsuit alleging fraud in Pfizer’s 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 Pfizer’s COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.
In an interview with The Defender, Jackson’s 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 “materiality” 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 contractor’s fraudulent activity, the fraud was not considered “material” 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.
“Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud,” attorney Robert Barnes said.”
Allegations and observations of Brook Jackson.
4. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (“Icon”), 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 (“SAE”) 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 trial’s protocol.
5. Defendant Ventavia Research Group, LLC (“Ventavia”) 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 “first successful COVID-19 vaccine,” 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 basis—up to a weekly limit—and rushed to enroll as many clinical trial participants as possible per week. Ventavia’s 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 Ventavia’s misconduct, despite numerous warning signs.
7. Ventavia’s 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:
• fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data;
• enrollment and injection of ineligible clinical trial participants, including Ventavia employees’ family members;
• failure to timely remove ineligible patients’ data from the trial;
• failure to maintain temperature control for the vaccine at issue;
• failure to monitor patients after injection as required by the trial protocol;
• principal investigator oversight failures;
• use of unqualified and untrained personnel as vaccinators and laboratory personnel;
• failure to maintain the “blind” as required, which is essential to the credibility and validity of the observer-blinded clinical trial;
• ethical violations, such as failure to secure informed consent and giving patients unapproved compensation;
• improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size);
• failure to ensure that trial site staff were properly trained as required by good clinical practices;
• safety and confidentiality issues, including HIPAA violations; and
• other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements.
8. Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. Issues were improperly documented or hidden away in “notes to the file,” and not corrected.
What was the result of this lawsuit?