Whistleblower Brook Jackson sued Defendants Pfizer, Ventavia Research Group, LLC, and Icon, PLC for deliberately withholding information from the United States about the safety and efficacy of their vaccine (BNT162b2) by concealing violations of the clinical trial protocol and federal regulations, including falsifying clinical trial documents. Jackson tried to correct the problems internally but was ignored and then fired after she called the FDA hotline to report trial protocol violations and safety concerns.
Out of work and out of options, she then filed a qui tam case under the Federal False Claims Act to bring the situation to the attention of the Department of Justice. The case remained sealed for a year while the DOJ investigated. Ultimately the DOJ declined to join the whistleblower in litigating the case.
The case stems from Pfizer’s contracting its clinical trial to Icon an Irish clinical research company with 160 testing sites worldwide.
Pfizer also contracted with Ventavia, where Ms. Jackson worked as a Regional Director, for testing in 1500 clinical trial patients in Texas.
In the race to get to market Ms. Jackson alleges:
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; a freezer was unplugged. para. 163.
failure to monitor patients after injection as required by the trial protocol; They did not properly track when clinical trial participants
developed symptoms of COVID-19. para. 197.
principal investigator oversight failures; Dr. Mark Koch, the principal investigator at Ventavia’s Fort Worth location, signed records for patients he did not personally or adequately examine. para. 201.
use of unqualified and untrained personnel as vaccinators and laboratory personnel; Vaccinators were trained over the phone. para. 173. Ventavia eventually brought in employees’ friends and family members on weekends to help “catch up” on quality control. para. 193.
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; Patients were injected prior to obtaining informed consent. para. 164. Signatures were mismatched. para. 168.
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; a wall calendar posted near a reception area visible to all staff and patients contained patients’ names, phone numbers, and health information. para. 207; and,
other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition
Regulations and their DoD supplements.
The Department of Defense purchased 100 million doses of the Pfizer BioNtech product for $1.95 billion dollars. The False Claims Act is a triple damage statute so a recovery could be almost $6 billion.
The firm representing Ms. Jackson is Berg and Androphy which has participated in False Claims Act settlements worth 100s of millions of dollars. The firm has some staying power.