To address the urgent need of producing a vaccine against Covid-19, in May 2020 the Government launched Operation Warp Speed, i.e., an interagency partnership between the United States Department of Defense (DoD) and the United States Department of Health and Human Services which aimed at accelerating the development acquisition and distribution of a Covid-19 vaccine.
Soon thereafter Pfizer started working on the vaccine and in July 2020 it entered in an agreement with the Government for the distribution of the vaccine, provided that it had received approval or Emergency Use Authorization by the Food and Drug Administration (FDA). In order to obtain such authorization, before starting clinical trial of its vaccine, Pfizer submitted an Investigational New Drug Application (“IND”) to the FDA whereby it committed to: (i) conduct the trial in accordance with applicable regulatory requirements; and (ii) utilize an Institutional Review Board for continuing review and approval of the trial. After Pfizer announced the results of its clinical trial, the FDA concluded that the key criteria for issuance of emergency authorization were met and approved Pfizer’s vaccine for individuals 16 years of age and older.
However, a former employee at one of the testing sites alleged that she had witnessed numerous violations of Pfizer’s clinical trial protocol. Notably, in the site where she worked, the vaccine had been administered also to ineligible participants; while the clinical trial should have been an observer-blinded study, there were some incidents that unblinded or had the potential to unblind staff and participants; there had been temperature deviation in the vaccine samples; the vaccine had sometimes been administered before obtaining the participants’ informed consent; some employees who had administered the vaccine were unqualified or not properly trained. She also alleged that she had observed several safety and ethical issues. For all these reasons, the former employee filed suit against Pfizer for false claims. Namely, she alleged that it had knowingly presented false and fraudulent claims for payment or approval to the United States.
By decision of 31 March 2023, the District Court of Texas dismissed the former employer’s claim and ruled in favor of Pfizer. In its reasoning, the Court noted that the agreement Pfizer had stipulated with the Government did not condition payment on regulatory or protocol compliance, but on the fact that Pfizer had obtained the authorization by the FDA, something which had actually occurred. It also stressed that the plaintiff had not brought before the court sufficient factual allegations indicating that the alleged violations in the sites where she worked had resulted in the FDA receiving fabricated, inaccurate, or misleading data about the safety or efficacy of the vaccine. Besides, even if plaintiff’s “allegations could support an inference that the safety and efficacy data [pertaining to the testing site where she worked] was unreliable, a conclusion that the Emergency Authorization criteria would not have been met without the [such] data is implausible considering that authorization was based on “the totality of available scientific evidence and [such testing site] only enrolled about 3% — approximately 1,500 of nearly 44,000 — of the total clinical trial participants”.
Reference: United States ex rel. Jackson v. Ventavia Rsch, United States District Court for the Eastern District of Texas, Beaumont Division, 31 March 2023.
