This article the Brook Jackson lawsuit against Pfizer, Ventavia, and Icon regarding the COVID-19 vaccine trials was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.
On March 31, 2023, District Federal Court Judge Michael J. Truncale dismissed the Brook Jackson lawsuit that claimed that Pfizer, Ventavia, and Icon defrauded the United States via COVID-19 vaccine clinical trials. The dismissal mostly accepted the claims in the motion to dismiss, claims I have discussed before, but since this is complicated material, it is worth going over it again in the context of this decision.
This post will explain the lawsuit shortly, then explain the decision, why this is a strong decision that is unlikely to be overturned, and shortly discuss the response from Ms. Jackson and her lawyers.
The Brook Jackson lawsuit against Pfizer
As explained in the decision (and the complaint, as I summarized in my previous post), Brook Jackson worked as a regional director for Ventavia Research Group for two weeks in September 2020. At the time, Ventavia was operating three of the clinical trial sites for Pfizer’s large stage III trial of its mRNA COVID-19 vaccine. Pfizer’s trial enrolled 46,661 people, half of which got the vaccine and half a saline placebo, and had 160 vaccine testing sites around the world. The three sites operated by Ventavia enrolled around 1,500 people. ICON – the third defendant – was “responsible for ensuring compliance with reporting requirements and clinical trial protocol,” as the decision explained.
From the start of her tenure, Ms. Jackson actively warned Ventavia’s people about what she described as violations of regulation in the sites she oversaw. Much of her complaint includes those regulatory violations, and the decision summarizes them in detail on pages 6-11. PP. 11-14 explain Ms. Jackson’s claim that she was fired in retaliation for reporting violations.
At this stage, the court assumes her claims are true since we are before fact-finding and the question is whether there is enough legal basis to proceed to fact-finding on these claims. So it’s important to remember that at this point, the claims have not been examined by the court. I am not repeating these claims here, because they were not very relevant to the decision, but I certainly acknowledge there may have been violations by Ventavia, and that it was Ms. Jackson’s responsibility to report violations or potential violations, and she did.
And for all I know, she may have been fired over those reports, though that is not what Ventavia claimed. Ms. Jackson also reported these alleged violations to the FDA and, at some point, to the Department of Defense. Her claims there certainly deserved investigation – and the FDA may or may not have investigated them thoroughly.
The FDA did not find them to justify refusing to authorize or approve Pfizer’s vaccine, whether because they did not find the claims correct, because they did not find the violations severe enough, they found the violations were corrected, or because Ventavia only enrolled a small portion of trial participants. I do not know the FDA’s reasoning, but they did not – as Ms. Jackson clearly would have preferred, from her Twitter feed – revoke the Emergency Use Authorization (EUA) or license that she described as “bogus”.
Ms. Jackson, therefore, filed a qui tam lawsuit – a lawsuit as a realtor under the False Claims Act. I have already explained the act in my previous post, so I will simply repost the explanation here:
The False Claims Act goes back to the 19th century, though its current form is much changed from the original act. At its core, it allows a private individual to bring a lawsuit in the name of the United States government against a false claim – a fraudulent demand for payment – to the government and allows the private party to collect up to 30% of the payment.
Ms. Jackson brought claims under two provisions of the False Claims Act, codified in 31 U.S.C. §3729 (1)(A) and (B). These sections allow claims against anyone who –
(A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval;
(B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim;
In essence, she would have to show that the companies (legal people) she’s suing:
1 – Submitted a false or fraudulent claim for payment or approval, or made a false record “material” to such a claim. Claims can be false factually or legally. False legal claims either expressly say that the submitter complied with regulations or strongly imply it.
2 – That the claim or record was “material” – whether they induced, or contributed to, the payment or approval.
3 – Either that there is a false record supporting the claim, or “falsity, causation, knowledge, and materiality.” The people sued need to “know, deliberately ignore, or recklessly disregard the falsity of their claim.”
In other words, the False Claims Act is not an “I can make government revoke the license to a vaccine I do not like” claim, or an “I can sue companies that I think did not follow regulations” act, but it’s specifically an act to allow recovery of monetary fraud against the United States.
That’s the problem Ms. Jackson faced, and the reason her claims were dismissed: essentially, Ms. Jackson’s claim is “regulatory violations make the trial data unreliable, and therefore the vaccine should not have been authorized or approved and Pfizer should not have been paid for it.”
That’s not what the act is about.
I will add that the judge handling Ms. Jackson’s claim was appointed by President Trump, which would make it harder for anti-vaccine activists to blame political opinions for the decision (though they can, and likely would, try to personally attack him – as Brook Jackson already did).
Decision against the Brook Jackson Pfizer lawsuit
Essentially, Judge Truncale found that whatever the truth about the regulatory violations, Brook Jackson has not shown a false claim for money by the defendants, Pfizer, Ventavia, and Icon, so this is not a good case under the False Claims Act.
He also found that Ms. Jackson’s suggested amendment to the complaint would not fix the problem, so dismissed it with prejudice – which means Ms. Jackson cannot refile the claim, and all she has left to save this part of her lawsuit is an appeal. The judge did dismiss her retaliation claim “without prejudice,” so her lawyers can amend that part of the complaint and refile – though their chances there would be tricky, too.
Judge Truncale summarized the standard for assessing the law by saying:
In order to assess liability under § 3729(a)(1)(A) or § 3729(a)(1)(B), the Fifth Circuit asks
(1) whether ‘there was a false statement or fraudulent course of conduct; (2) made or carried out with the requisite scienter; (3) that was material; and (4) that caused the government to pay out money or to forfeit moneys due (i.e., that involved a claim).
In the first part, Ms. Jackson claimed that Pfizer’s claims to be paid by the Department of Defense were false because they required compliance with FDA regulation and the Federal Acquisition Regulations (FAR).
She alleged that the claims were “legally false” because Pfizer violated the conditions for the payment. The defendants, however, pointed out that the contract in question was a special agreement under the Department of Defense’s “Other Transaction Authority,” and therefore, is not subject to the Federal Acquisition Regulations. Ms. Jackson objected to using that source, but the court stated that it will “not veto” DoD’s judgment to use that authority and its judgment that that authority was relevant to “enhancing the mission effectiveness of personnel of the Department of Defense.”
The contract itself makes no mention of regulations – it simply conditioned payment on delivering an FDA-authorized or approved vaccine, and that was done. Therefore, the payment was not conditioned on compliance with the regulation.
Passing references to FDA requirements that Ms. Jackson mentioned in the oral hearing does not change the reality that the specific payment clauses in the contract only focused on delivering an FDA authorized or approved vaccines, and “specifies ‘[f]or clarity’ that ‘the Government will have no right to withhold payment in respect of any delivered doses unless the FDA has withdrawn approval or authorization of the vaccine.’” This makes it fairly clear that the only condition for payment is an FDA-authorized or approved vaccine.
The United States also submitted a “Statement of Interest” agreeing with Pfizer on this point. The United States’ statement said:
The complaint does not identify any provision in the [Contract – referred to as the “Statement of Work, or SOW] for the Project Agreement between Pfizer and the Army that conditioned Government payment for the vaccine on Pfizer’s compliance with the clinical trial protocol or regulations. The SOW, which is attached to the complaint, further sp*ecifies that the Army did not regulate the conduct of the clinical trial, which is “out-of-scope” for the purchase agreement between the Army and Pfizer. In short, the complaint does not plead factual content to support a conclusion that compliance with the clinical trial protocol or regulations was necessary under the contract between Pfizer and the Army such that clinical trial violations would give rise to a claim for express or implied certification liability.”
This also makes sense policy-wise. Sometimes, regulatory violations justify seeing a product’s license as invalid or revoking it; sometimes they do not. And it makes sense that this decision be made by the authority directly regulating the product – here, FDA – rather than by government agencies that buy the product but may not have the expertise to oversee it.
Brook Jackson also claimed that the Pfizer trial protocol and other documents confirming compliance with regulations show false statements of compliance for payment, but the court pointed out that these documents are not claims for payments – so not basis for Federal Claims Acts violations (again, the act is there to allow recovery of payments made by the government because of false claims, not to punish every regulatory violation).
The only documents the court was willing to look at for false statements were Pfizer’s invoices, which Brook Jackson did not attach to the complaint, but Pfizer did. The court explains that “…Pfizer’s actual invoices do not contain any certifications about compliance with the clinical trial protocol, FDA regulations, or FAR. [..]. Rather, Pfizer’s invoices certify that “the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”
At oral argument, Ms. Jackson claimed that the words “in accordance with the agreement” in the invoice meant Pfizer would meet the FDA’s requirements. The court rejected that, saying:
First, reading “in accordance with the agreement” in isolation is misleading. When the phrase in which those words appear—“I certify that the amounts invoiced are for costs incurred in accordance with the agreement”—is read in its entirety, the meaning becomes clear. That is, the price reflected in the invoice—$19.50 per dose—matches the price stated in the Project Agreement. [Dkt. 17-1 at 319; Dkt. 37-2 at 2]. Second, even if “in accordance with the agreement” did refer to some other part of the Project Agreement, the Court has already found that Pfizer’s clinical trial—the activity that Ms. Jackson bases her claims on—was “out of scope” for the Project Agreement between Pfizer and the DoD. Put simply, Pfizer’s invoices do not contain any express false certifications.
The court also found that there are no specific representations that imply compliance in the invoice, so no implied false statements either.
Brook Jackson also tried to claim that the Pfizer clinical trial protocol and “falsified source documents and data” in it are false records triggering the other section of the False Claims Act. Defendants countered that by claiming that there must be false claims seeking payment from the government – if the contractual payment is justified, there is no claim. This, the court agreed, matched the jurisprudence of the Fifth Circuit.
Although Congress amended the False Claim act in between, the amendment did not remove the requirement of a false claim, the court found. Since the contract entitled Pfizer to payment as long as it delivered an FDA-authorized or approved vaccine, and it did, there was no liability here.
Although the complaint did not raise it, in her response to the motion to dismiss Ms. Jackson added another claim – that Defendants are liable under a “fraudulent inducement” theory, which essentially means that the invoices were based on previous falsehood used to obtain the emergency authorization, and that previous dishonesty meant the contract was procured by fraud, and therefore, the contract-based-claims are false claims.
The court dismissed this because it found that Ms. Jackson is not alleging (claiming) that Pfizer procured the vaccine contract through false statements because she is claiming the “lies, omission, and fabrications” to FDA happened after the product.
This is the only part of the decision that anti-vaccine activist Steve Kirsch repeated on Twitter. Mr. Kirsch, however, did not bother repeating the judge’s next point, which was that it did not need to decide this issue since Ms. Jackson did not raise it in her complaint, and it cannot do so for the first time – add a new legal theory – in response to a motion to dismiss.
In addition to not making the case for a false claim, the court found that the misrepresentations alleged – based on contractual violations – was also not material, and to make the case, the misrepresentation “must be material to the Government’s payment decision.”
Here, because the government paid the claim in full while knowing of the alleged violations, they were likely not material.
The court discusses who needs to know – the FDA which authorized or approved the vaccine, or the DoD which paid for it. The court said that “…well-pleaded facts require drawing the inference that the DoD did not know about the alleged fraud prior to February 22, 2022, approximately two years after it paid Pfizer’s first invoice.”
But the court finds that the contract between the party left the decision on whether the vaccines were “fit for purchase” to FDA – so the question is whether FDA knew of the alleged violations, and it did, at least since September 2020, when Ms. Jackson complained to them (and the FDA did follow up and talk to her).
Despite that, the FDA has continued to authorize – and even licensed – Pfizer’s vaccine, and has not revoked that. Payments from the government for the vaccine continue. FDA’s review process was, said the court, “public and independent” and “thorough”, and the United States government – unusually – filed a statement supporting the dismissal of Ms. Jackson’s complaint.
The court goes on to say:
Ms. Jackson disagrees with the FDA’s decision to authorize Pfizer’s vaccine. Congress, however, “enacted the FCA to vindicate fraud on the federal government, not second guess decisions made by those empowered through the democratic process to shape public policy.” Harman, 872 F.3d at 668–69. “When the government, at appropriate levels, repeatedly concludes that it has not been defrauded, it is not forgiving a found fraud—rather it is concluding that there was no fraud at all.”
The court also adds, in another section, that there is no real allegation that the alleged violations led to “the FDA receiving fabricated, inaccurate, or misleading data about the safety or efficacy of the vaccine” – the complaint does not connect the alleged violations to problems. Further, since the authorization is based on the total available data, Ventavia only enrolled 3% of participants and the claim touches on a fraction of that, there is nothing there to show that the criteria for emergency use authorization were not met.
Ms. Jackson’s retaliation claim was also dismissed because she did not allege that she was trying to show illegality or fraud as the Federal False Claim Act states – essentially, she was not, as explained above, alleging false claims for payment. But the court did give her the ability to amend that part of her complaint, and her lawyer stated that they would refile it.
Responding to the dismissal, Ms. Jackson expressed understandable disappointment, and both she and her lawyer announced an intent to appeal the decision. Ms. Jackson also said they are “working to convene a grand jury”, whatever that means.
Her appeal would usually have little chance because the judge made it very clear that she did not provide a basis for liability under the False Claims Act. Although some of the recent decisions from the Fifth Circuit have been in tension with existing law, I see no reason to let them off the hook on this; they should stick to the law and uphold the dismissal, and if they fail to do that, they should be criticized and overturned by the Supreme Court.