United States v. Ventavia Research Grp.
| Decision Date | 31 March 2023 |
| Docket Number | Civil Action 1:21-CV-00008 |
| Parties | UNITED STATES OF AMERICA ex rel. BROOK JACKSON, Plaintiff, v. VENTAVIA RESEARCH GROUP, LLC; PFIZER, INC; ICON, PLC, Defendants. |
| Court | U.S. District Court — Eastern District of Texas |
ORDER AND OPINION GRANTING DEFENDANTS' MOTIONS TO DISMISS
Before the Court are three Motions to Dismiss filed by Defendants Pfizer, Inc. (“Pfizer”) [Dkt. 37], ICON, PLC (“ICON”) [Dkt. 51], and Ventavia Research Group LLC (“Ventavia) [Dkt. 53]. In her Amended Complaint Relator Brook Jackson asserts causes of action against Pfizer, ICON, and Ventavia (collectively “Defendants”) for alleged violations of the False Claims Act (“FCA”).[1] [Dkt. 17]. Defendants move to dismiss the Amended Complaint pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b).[2] On January 18, 2022, the United States declined to intervene in this action. [Dkt. 13]. On October 4, 2022, the United States filed a Statement of Interest Supporting Dismissal of the Amended Complaint. [Dkt. 70]. The Court heard oral argument on the Defendants' Motions on March 1, 2023. [Dkt. 94]. For the reasons discussed below, the Court grants Defendants' Motions.
There was no vaccine to protect against COVID-19 in the early months of the pandemic. To address this urgent need, the Government launched Operation Warp Speed on May 15, 2020. [Dkt. 17 at 18]. Operation Warp Speed was an interagency partnership between the United States Department of Defense (“DoD”) and the United States Department of Health and Human Services that coordinated federal efforts to accelerate the development, acquisition, and distribution of a COVID-19 vaccine. Id. Soon thereafter, Pfizer began working to develop a vaccine. Id. at 24.
In June 2020, the Food and Drug Administration (“FDA”) published guidance regarding the data and information needed to support issuance of Emergency Use Authorization (“Emergency Authorization”) for COVID-19 vaccines.[4] [Dkt. 17-1 at 312; Dkt. 37 at 11 n.5]. The guidance explained that the FDA may issue Emergency Authorization upon its determination- based on “the totality of the available scientific evidence”-that: (1) “studies have demonstrated the safety and effectiveness of the vaccine”; and (2) “the known and potential benefits of a product, when used to diagnose, prevent, or treat serious or life-threatening diseases, outweigh the known and potential risks of the product.” Id. The guidance specifies that “the primary efficacy endpoint estimate for a placebo-controlled efficacy trial should be at least 50%” in order to “ensure that a widely deployed COVID-19 vaccine is effective.” Id.
In July 2020, while Pfizer's vaccine was still under development, the DoD entered into a contract (the “Project Agreement”) with Pfizer, under which Pfizer would deliver 100 million doses of a FDA authorized or approved vaccine to the Government on a fixed price per dose basis, in accordance with a “Statement of Work.”[5] [Dkt. 17-1 at 303-37]. The Statement of Work provides that the Government will pay $1.95 billion for 100 million doses-or $19.50 per dose- of Pfizer's vaccine, if Pfizer first secures FDA approval or Emergency Authorization. Id. at 319.
After executing the Project Agreement, Pfizer endeavored to launch a clinical trial in order gain FDA approval or Emergency Authorization for its vaccine. [Dkt. 17 at 6-7]. Before starting the trial, Pfizer submitted an Investigational New Drug Application (“IND”) to the FDA. Id. at 19, 36; [Dkt. 17-1 at 51-53]. Pfizer's IND included a cover sheet, known as Form FDA-1571, wherein Pfizer committed to: (1) conduct the trial in accordance with applicable regulatory requirements; and (2) utilize an Institutional Review Board for continuing review and approval of the trial.[6] [Dkt. 17 at 19, 36] (citing 21 C.F.R. § 312.23(a)(iv)-(v)). Pfizer also included its trial protocol in the IND. [Dkt. 17 at 19, 36].
Pfizer enlisted the help of ICON, an Irish-headquartered clinical research organization, and Ventavia, a testing site operator, to conduct the clinical trial. Id. at 7. ICON and Ventavia each submitted a document titled Form FDA-1572 to Pfizer and the FDA, in which ICON and Ventavia certified that they would: (1) conduct the trial in accordance with protocol and FDA regulations; (2) obey informed consent and Institutional Review Board reporting requirements; (3) report adverse events; (4) ensure that all employees were informed of their obligations; and (5) make no changes to the trial without Institutional Review Board approval.[7] Id. at 20, 36, 73; [Dkt. 17-1 at 55-56].
Pfizer conducted a placebo-controlled, randomized, observer-blind clinical trial to evaluate the safety, tolerability, immunogenicity, and efficacy of its vaccine against COVID-19 in healthy individuals.[8] [Dkt. 17-1 at 143]. A total of 43,661 participants enrolled in the clinical trial across 160 testing sites worldwide. [Dkt. 17 at 7, 24; Dkt. 17-1 at 292]. Pfizer delegated oversight of those testing sites to ICON. [Dkt. 17 at 7]. ICON was responsible for ensuring compliance with reporting requirements and clinical trial protocol. Id. Pfizer contracted with Ventavia to operate three testing sites in Houston, Fort Worth, and Keller, Texas. Id. Approximately 1,500 participants enrolled at the Ventavia testing sites. Id.
Pfizer announced the results from its clinical trial on November 18, 2020. Id. at 25. Data analysis from 41,135 trial participants showed that a two-dose regimen of the vaccine was 95% effective against COVID-19. [Dkt. 17-1 at 290-92]. Safety data showed a favorable safety profile and raised no serious safety concerns. Id. Pfizer asked the FDA to authorize the vaccine for emergency use on November 20, 2020. [Dkt. 17 at 25]. Relying on Pfizer's clinical trial results, the FDA concluded that the key criteria for issuance of Emergency Authorization were met: the “totality of the available data provide[d] clear evidence” that the Pfizer vaccine “may be effective in preventing COVID-19,” and that “the known and potential benefits outweigh[ed] the known and potential risks.” Id. at 25 n.5.[9] The FDA noted that its review process also included “public and independent review” and that it had “conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.” Id. Accordingly, the FDA granted Emergency Authorization on December 11, 2020.[10] Id. at 25. Pfizer sent its first invoice to the Government on December 31, 2020.[11] [Dkt. 37-2 at 2]. Pfizer certified in its invoice that the invoice was “true and correct, prepared from Pfizer's books and records, and in accordance with the Pfizer-DoD contract.” [Dkt. 17 at 73] (citing 48 C.F.R. 52.232-32(m)).
On August 23, 2021, the FDA fully approved Pfizer's vaccine for individuals sixteen years of age and older by granting a Biologics License Application. [Dkt. 17 at 9]. To date, the FDA has not revoked its approval of Pfizer's vaccine, and the Government continues to provide the vaccine to Americans at no cost.[12] Id. at 18 n.2.
Ms. Jackson worked as a Regional Director at two of Ventavia's testing sites from September 8 to September 25, 2020. Id. at 11, 15. During her eighteen days of employment, she allegedly witnessed numerous violations of Pfizer's clinical trial protocol. Id. at 36-59. Many of the alleged violations involved a failure to maintain accurate documentation. Ventavia was required to scan or enter data from clinical trial participants' “source documents” into a database so that it could be passed on to ICON and Pfizer Id. at 12. Ventavia was also responsible for “quality checking” all source documents before scanning or uploading them. Id. Ms. Jackson alleges, however, that on multiple occasions, Ventavia falsified information when conducting quality checks or otherwise hid protocol violations from Pfizer and ICON. Id. at 36-59. The Court turns to the alleged protocol violations.
Pfizer's protocol did not permit pregnant women to participate in the clinical trial. Id. at 36. Ms. Jackson alleges that Ventavia nonetheless administered the vaccine or placebo to pregnant women and did not report to Pfizer and ICON that pregnant women participated in the trial. Id. at 37.
Relatedly, Ventavia also allegedly considered women with a tubal ligation as not capable of becoming pregnant, even though the protocol did not list tubal ligation as an accepted contraception method. Id. Ms. Jackson contends that Ventavia's violations involving tubal ligation would have been “obvious from the source documents,” but that Pfizer and ICON ignored these “red flags” and failed to exclude trial data from ineligible participants. Id.
Ventavia also allegedly violated protocol by not testing a participant for COVID-19 until after administering the vaccine. Id. at 38-39. Ventavia allegedly falsified this participant's source document by crossing out a question about why vaccination preceded informed consent and adding a comment that the informed consent time was incorrect. Id. Ventavia allegedly further violated protocol by enrolling Ventavia employees and their family members in the clinical trial, id. at 39, and by examining married couples or groups of friends at the same time instead of individually. Id. at 53. Ms. Jackson contends this that last practice would have been apparent to Pfizer and ICON from overlapping times in the source documents. Id.
The clinical trial was an observer-blinded study. Id. at 39. The only “unblinded” people at Ventavia's testing sites should...
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