Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial
This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine 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.
Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.
But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations.
Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness.
Contents
0.1 The Brook Jackson case
0.2 The False Claims Act and Ms. Jackson’s case
0.3 Claims by the attorney for Brook Jackson
0.4 Breaking of the Seal
0.5 So what now?
The Brook Jackson case
From the materials in the litigation, Brook Jackson was hired by Ventavia. This company describes itself as “a leading clinical research firm, specializing in trials of pediatric, maternal, and adult vaccines and other medicines,” as a regional director. Jackson worked for Ventavia for 18 days, and then was fired, and unsurprisingly, there are conflicting claims about why she was fired.
Jackson, in her complaint, presents herself as immediately noticing serious problems with Ventavia’s management of the clinical trial, and alerting her superiors to those issues. She implies that she was fired because of her efforts to correct such violations. She also suggests that she was fired because she reported the violations to FDA, though there’s no indication that at the time she was fired, the company knew that she did that.
Brook Jackson says, in her complaint:
On the following morning, Relator called the FDA’s hotline to report the clinical trial protocol violations and patient safety concerns she witnessed. Relator was terminated from her position at Ventavia that same day—September 25, 2020—under the pretext that she was “not a good fit.” Relator had never been formally disciplined or reported for any failure regarding her job performance.
I think this strongly implies that the call to the FDA was the reason for the termination.
On the other hand, Ventavia claims that Jackson “came with an agenda,” violated company policy and patient privacy, and unblinded herself and others from participants in the clinical trials. It concludes: “Relator was fired for violating company policy and patient confidentiality.”
It’s certainly possible that the company fired Ms. Jackson for causing waves and pointing out real issues. It’s also possible that the company fired Ms. Jackson for violating rules and policies and ignoring patient privacy. At this point, I do not know. What is clear is that Ms. Jackson and Ventavia are unfriendly towards each other. That does not, of course, mean that what Ms. Jackson says is not true.
On January 8, 2021, Ms. Jackson filed her claim under the False Claim Act. I will discuss the act and its requirements below, but in essence, Ms. Jackson’s complaint is almost completely a recitation of alleged violations of the trial protocol by Ventavia. Ms. Jackson alleges that Ventavia enrolled subjects that should not have been enrolled, and mentions two types of subjects – family members of employees, and pregnant women.
She also alleges that Ventavia was not careful about blinding and engaged in practices that unblinded the participants to trial personnel. She alleges that Ventavia’s recording practices were shoddy and even fraudulent, with changes made inappropriately. She alleges other instances of carelessness, for example in keeping the vaccines at the right temperature or in disposing of materials. If we take Ms. Jackson’s claims as true – a big if – the picture we arrive at is of two very sloppily managed trial sites (the two she observed).
Some of the claims also sound like disagreements rather than actual violations – for example, Ms. Jackson mentioned that patients were put in the hallways and “checked on” as monitoring, and there seems to have been actual disagreements between Jackson and her superiors on whether that was enough to count as monitoring.
We should be careful about accepting her claims, of course — this is a dismissed employee, and Ventavia strongly denies at least some of her claims. For example, Ventavia alleges that the lack of blinding was actually due to the actions of the employee who entered without permission closed-off areas she was not allowed to enter, took pictures of documents that were locked and not to be public with her personal phone, and engaged in other violations that could compromise blinding.
That does not mean Ms. Jackson was necessarily lying or even wrong — Ventavia has every interest to blacken her name and may have violated protocols. But it does mean that at this early stage, her allegations need to be approached with care.
We just do not have enough information at this point to know what is going on with the specific allegations, and both parties should be approached with care. One of the criticisms of a problematic article about the claims Ms. Jackson’s made was accepting her claims at face value, without giving any weight – indeed, maybe not even soliciting – responses from the companies she accused.
What is clear is that even if Ms. Jackson’s allegations are true, her lawsuit likely cannot meet the legal requirements of a False Claims Act lawsuit, or retaliation under it. Further, even if her allegations are true, the next conclusion she tries to draw from them doesn’t hold. Brook Jackson argues, in her complaint, that:
Due to Defendants’ scheme, millions of Americans have received a misbranded vaccination which is potentially not as effective as represented. The vaccine’s U.S. Food and Drug Administration (“FDA”) authorization resulted from a deeply flawed clinical trial that violated FDA regulations. Defendants have profited from the COVID-19 pandemic at the expense of the United States and its citizens by abusing the scientific process.
The lawsuit’s allegations simply do not support that. Ms. Jackson alleges regulatory violations on two trial sites that cover 1500 people out of over 40,000. Even if her claims could raise issues about safety and effectiveness – a very big if, and some of the alleged violations (like not properly disposing of needles) are not even related to the clinical trial – they would apply to a small fraction of trial participants, and by no means negate the results of the trials.
Going from there to a claim that the authorization was based on a “deeply flawed clinical trial” is taking a very, very big step that the complaint does not support.
Further, this is no longer January 2021. We have extensive real-world data about Pfizer’s vaccines from hundreds of millions of doses given in the United States and literally billions around the world, and neither Ventavia nor Pfizer can actually control that data. Even if the complaint gave good grounds to doubt the safety and effectiveness data overall – and I do not think it does – it would not show a problem with the authorization or approval given the other data. Trying to use this complaint to argue against authorization and approval generally is simply unconvincing.
The False Claims Act and Ms. Jackson’s case
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:
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.
That the claim or record was “material” – whether they induced, or contributed to, the payment or approval.
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.”
The problem Ms. Jackson’s claims face going in is that it’s not clear she has anything to support the elements of the act. Brook Jackson is suing three companies. Ventavia did not submit any payments to the government, so Ms. Jackson would likely try to use prong (B) – making a false record in support of a claim for payment.
But even there, she would have to show that a false claim for payment was submitted to the government, or a false approval or authorization. For Pfizer, she would run into the problem that her complaint nowhere alleges Pfizer submitted a false claim. She claims Pfizer should have “constructive knowledge” of some of the problems she runs into, but she doesn’t actually connect anything Pfizer did to a false claim.
As pointed out by the motions to dismiss of both Pfizer and Ventavia, the False Claims Act is not there to address general regulatory violations by companies. It is there to address false claims for payment or authorization. In this case, the false claims for payment Ms. Jackson is alleging is that Pfizer got paid for vaccine doses by the United States Department of Defense. But not only did she not show misrepresentation on Pfizer’s part based on the regulatory violations she pointed to, but as Pfizer pointed out, its invoices did not say anything about regulatory compliance: all they were saying was that they are submitting a certain number of doses.
Ms. Jackson could try to call this out based on the fact that a condition of the Department of Defense purchasing was FDA authorization or approval. If that was based on fraud, she would allege, that the payment was based on fraud, too. But there are several problems here, too. The less severe one is that not all regulatory violations are also a fraud, but Ms. Jackson is claiming fraud, even if her complaint is scant on details for it.
More serious is the fact that Ms. Jackson is trying to claim the government was defrauded while, as both Pfizer and Ventavia pointed out, the FDA and the Department of Defense are pretty sure they were not defrauded. First, Ms. Jackson herself sent her claim to both FDA and the Department of Defense, so the government knew of the claims before authorizing – or paying – for the vaccines.
The FDA email was on September 25, 2020, before authorization. The letter to the Department of Defense was from December 14, 2020, before doses were provided to people. If the government knew of the allegations, where is the fraud?
The essence of fraud is that a party tricked someone else, making them think the reality is not as it is. You cannot trick someone who actually knows the facts. FDA also said openly that it does not think that it was defrauded – even knowing of Ms. Jackson’s claims. In response to her claim, a spokesperson for FDA said:
Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.
The Department of Defense, too, continued to buy Pfizer’s vaccines. This is not surprising: again, even if everything Ms. Jackson’s said was correct, and even if Ventavia has at no point improved its practices, Ventavia handled only 1,500 people out of 43,000 trial participants. And since then, many external studies examined the vaccine’s safety and effectiveness. FDA is on solid ground in continuing the authorization and licensing of Pfizer’s vaccine – and in line with expert agencies from all around the world.
If the authorization and licensing is not fraudulent, and the purchase based on it is not fraudulent, where is the false claims act? Again, even if we assume that Brook Jackson showed real regulatory violations, the False Claims Act is not one of the FDA’s enforcement mechanisms. If there’s no fraud against the government, there’s no false claims act.
I could stop here, but I want to address two additional issues:
Claims that were made by Ms. Jackson’s current lawyer about the case.
Ms. Jackson’s failure to abide by the seal on the case.
two covid vials on pink surface
Claims by the attorney for Brook Jackson
At some point during the case, Ms. Jackson replaced her initial lawyers from the law firm of Berg and Androphy with attorney Robert Barnes. In a video shared on Rumble by anti-vaccine activist Steve Kirsch, Mr. Barnes claimed that Pfizer’s motion to dismiss their grounds for dismissal is:
…that it doesn’t matter if they submitted fraudulent certifications to the government, it doesn’t matter if they submitted false statements under penalty of perjury to the government. It doesn’t matter if they lied about the safety and efficacy of these drugs mislabeled in my opinion as vaccines. Because the government was in with them on it. The government knows what’s going on and the government still has given them the check anyway. Was it really fraud if the government is their co-conspirator? That is in essence Pfizer’s defense to the case.
A few things about this. First, by trying to claim Pfizer’s vaccine is not a vaccine, Mr. Barnes puts himself strongly in the anti-vaccine camp. Second, this is a serious misrepresentation of Pfizer’s position.
Here is Pfizer’s motion to dismiss. Note that in no place does Pfizer say it committed fraud. In fact, Pfizer says it did not. First, as a technical point, Pfizer points out that their invoices to the Department of Defense did not include – and were not required to include – a certification of compliance with the regulations. Pfizer says: “Pfizer’s invoices do not contain certifications of compliance with FAR or any other federal regulations. Pfizer instead certified, in a more limited way, that “the amounts invoiced [were] for costs incurred in accordance with the agreement, the work reflected ha[d] been performed, and prior payment ha[d] not been received.” This certification is a truthful one, and it has nothing to do with the regulatory provisions cited in Relator’s complaint”. The “relator” is the term used for a citizen bringing a false claims act on the government’s behalf.
Second, Pfizer points out that “[t]he Government has also clearly rejected Relator’s allegations by issuing a recent public statement expressing “full confidence” in the data supporting authorization and approval of Pfizer’s product.” In other words, far from accepting that Ms. Jackson shows fraud, Pfizer is saying that FDA agrees that Ms. Jackson did not. FDA does not have to accept Ms. Jackson’s claims of problems. And even if they accepted her claims, they do not have to go from regulatory violations to saying that they were frauds. Here, they did not. FDA’s response suggests not that they’re conspiring with Pfizer, but that they do not think that there was a fraud.
Third, Mr. Barnes’ claims are also misleading on the law. The core of the False Claims Act is that the citizen is bringing a claim on behalf of the government to recoup money the government was defrauded of. In fact, 70% of any recouping would go to the government and only 30% to the citizen. If the government claims “we were not misled”, there is no such fraud. The government is not a co-conspirator in that case; the payment claim was simply not a fraud.
In essence, Mr. Barnes is misrepresenting Pfizer’s response that “we did not mislead the government, among other things because the government knows of Ms. Jackson’s claims and does not think it paid on a fraud” as saying something very different. Mr. Barnes, as a lawyer suing under the act, should know this.
Breaking of the Seal
Claims brought under the False Claims Act are sealed for at least 60 days to allow the government to decide if to take the claim over, and that period can be extended.
In this case, the case was filed in January 2021. The government decided not to intervene on January 18, 2022. The case was unsealed on February 10, 2022. But on January 17, 2022, Ms. Jackson Tweeted the complaint’s front page and several claims from it. Even before that, in November 2021 the BMJ published an article by a free-lance journalist based on the claims of the complaint. As part of its motion to dismiss, Ventavia pointed to this violation of the seal requirement, and to cases showing dismissal of claims because of similar violations of seal.
Similarly, Pfizer requested staying even partial discovery in part because it pointed out that Brook Jackson cannot be relied upon to respect the confidentiality of documents, even if she promises to do so, based on this.
I have mixed feelings about this. On one hand, it had taken over a year – not sixty days – for the government to respond and say they will not intervene in the case. That’s a long time to keep a complaint under seal, and it seems tricky to force litigants to wait.
On the other hand, false claim act claims are not usual claims. They are mechanisms for citizens to bring claims against the government, and the claim really is in the name of the government. Brook Jackson did not bring a personal wrongful dismissal claim (though she did include a retaliation claim against Ventavia), she is bringing a claim for false payment to the government. And when she’s doing that, she should respect the rules of the game – and yes, it does raise questions, since she ignored the sealing requirements here, whether she will respect any confidentiality requirements going forward.
So what now?
Before the court now are the complaints and the motion to dismiss. The court set a schedule for hearing them. The court partly “granted” Pfizer’s request to stay discovery but I’m not quite sure what it means. The court referred to an earlier order that did allow limited discovery as needed for the motions to dismiss.
Although the court did set trial dates, that does not mean they will happen – the next step really is litigating the motion to dismiss. In my view, Ms. Jackson’s claim is highly problematic and very likely to be dismissed, but it will be months before it is resolved. In the meantime, it can be misused to generate an anti-vaccine talking point. I hope this post can help with that.
https://www.skepticalraptor.com/skepticalraptorblog.php/brook-jackson-false-claims-lawsuit-against-ventavia-covid-19-vaccine-clinical-trial/
