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Home » Judge in Gardasil lawsuit throws out most claims

Judge in Gardasil lawsuit throws out most claims


This article about an HPV vaccine (Gardasil) lawsuit was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law San Francisco, who is a frequent contributor to this and many other websites, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively about vaccination’s social and legal policies in law journals. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines. This parent-led organization 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 20, 2024, the federal judge overseeing the multi-district litigation against Merck over its vaccine (Gardasil) which prevents infections caused by the human papillomavirus (HPV), a virus that can increase the risk of genital warts and various cancers, accepted large parts of Merck’s motion to dismiss in two cases that were to be “bellwether” cases.

The judge found that the plaintiffs could not proceed on their negligence claims, their claims that the plaintiffs were not warned, and their fraud claims. The judge did, however, allow claims of failure to warn the plaintiffs’ doctors and fraudulent concealment claims to proceed to discovery.

a police officer standing near white concrete pillars of a building Gardasil lawsuit
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The multi-district Gardasil lawsuit

As regular readers know, under United States law, claims of injury from vaccines routinely given to children need to be brought, first, to the no-fault vaccine injury compensation program. Anti-vaccine activists use this fact to claim – falsely – that vaccine manufacturers have no liability.

It is true that one type of claim, design defect claims, is preempted by the program – under a Supreme Court decision, it cannot be brought to the regular courts at all. But other claims can be brought (and of course, the program’s decisions can be appealed, first to the Court of Federal Claims and then to the Federal Courts, all the way to the Supreme Court).

This anti-vaccine trope is especially jarring when it comes from people directly involved in litigation against vaccine manufacturers, because those people, at least, have to know such litigation is possible – they do it. Consider, for example, Robert F. Kennedy Jr., who has claimed just this

Since 2020, one law firm has been bringing claims against Merck over its HPV vaccine, Gardasil. The law firm has worked closely with anti-vaccine leader Robert F. Kennedy Jr. in preparing these claims, and the claims largely echo the claims in a highly misleading anti-vaccine book I have reviewed before

Since there are many cases, they have been consolidated in one court, under one judge, in what is called multi-district litigation. All these cases are now heard in the federal district court for the Western District of North Carolina, Charlotte Division, before Judge Kenneth D. Bell. In the decision discussed here, Judge Bell put the number of cases at “nearly two hundred,” and mentioned (in footnote 2) that “Plaintiffs’ counsel informed the Court that the number of consolidated cases could increase by hundreds more over time.”

Unsurprisingly, Merck filed motions to dismiss in a number of these cases. This decision used two cases – Bergin v. Merck & Co., Inc. et al., No. 3:22-CV-00117, and America v. Merck & Co., Inc. et al., No. 3:22-CV-00585. (See Doc. Nos. 35 at pp. 2-4; Doc. No. 58 at 7) – as bellwether cases to assess Merck’s motions to dismiss “Plaintiffs’ alleged ‘design defect’ and ‘direct warning’ claims based on the argument they are preempted by the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-1, et seq. (the “Vaccine Act”) and their ‘manufacturing defect’ and fraud claims for allegedly inadequate pleading.”

As the decision explains, the question in a motion to dismiss is whether the complaint properly stated claims. As part of that analysis, “the Court “must view the facts presented in the pleadings and the inferences to be drawn therefrom in the light most favorable to the nonmoving party.”” The reason is that at this stage, we are deciding whether the party will have its day in court at all. It has not yet had a real chance to prove its case. So it gets the benefit of the doubt.

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The two Gardasil lawsuit Bellwether cases

What the court means by Bellwether cases is that the decision in these two cases will cover the rest of the cases – unless those cases make a good argument that it should not apply to them (and the court, at the end of its decision, gave plaintiffs in other cases time to do so). They are test cases for the legal theories. 

The first case, Payton Bergin’s case, involves a young woman who, in 2013-2014, was thirteen, and received two doses of Gardasil. She says her mom was influenced by Merck’s direct-to-consumer marketing. According to the decision, 

…prior to receiving her Gardasil injections, she had no known autoimmune diseases, and no autonomic issues. (Id. at ¶ 346). However, following her two Gardasil vaccinations, Ms. Bergin says that she experienced a series of physiological and neurological adverse events, including but not limited to mobility issues, short-term memory loss, chronic fatigue, severe headaches, tiredness, dizziness, fainting, hallucinations, chronic joint pain, amnesic spells, and encephalopathy. (Id. at ¶¶ 350-403). Thus, she alleges that Gardasil caused a wide variety of “autoimmune, autonomic, and neurological[] injuries” including “hypersomnia, orthostatic intolerance, autonomic dysfunction, and postural orthostatic tachycardia syndrome (“POTS”)” (Id. at ¶ 405).

It should be noted that studies in millions have found no link between HPV vaccines and autoimmune conditions generally. A 2018 review of the data reaffirmed that, and specifically, found no link to POTS. There is extensive evidence from all around the world about HPV vaccine safety, and it does not support the plaintiff’s claims. But this question is not before the court right now; determining whether the vaccines caused the plaintiff’s harm is a matter for later evaluation.

Right now, the court is only assessing if the plaintiff’s claims survive dismissal. The complaint mentioned that Ms. Bergin filed a claim in vaccine court, but later withdrew it (you can withdraw the claim if the court has not acted within a certain time frame) and filed this lawsuit instead. 

The second lawsuit involved Ashley America, who alleged that she received two doses of Gardasil at 18, in 2014-2015. Ms. America claims “that she experienced various adverse events, including chronic syncope (fainting), chronic dizziness, headaches, and concentration issues. She attributes “various medical conditions” to Gardasil, including “symptoms of POTS,” “non-epileptic seizures, related to autoimmune dysregulation, and neurocardiogenic syncope related to dysregulation of the autonomic nervous system.””

As mentioned above, the evidence does not support a link between HPV vaccines and POTS. Some of these other claims seem more than a little undefined. Unlike Ms. Bergin, Ms. America did not withdraw her petition from the program. Rather, her claim was denied. The case is not available online, but I have downloaded it via Bloomberg Law and it is cited in other cases. The court was not convinced by her claims. 

The court mentioned, during its analysis, that both complaints were lengthy, and not particularly well written. The court pointed out that “it is challenging for the Court to discern the precise nature of Plaintiff’s claims, which in many instances rely on sprawling and conclusory allegations and lump numerous theories of liability together.” 

Again, the causation issue is not yet before this court; discovery on these issues is in motion, as the decision mentioned, and it is for later. Another issue the court put aside is whether there was, in fact, a failure to warn the doctors. An issue there is about whether there was new information beyond what was in the insert, and that issue, too, needed further development before the court would be ready to decide it.

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Claimed closed off by the NCVIA

For the first two claims of the plaintiffs, the question the court addressed was whether they were available under the legal framework created by the 1986 National Childhood Vaccine Injury Act. In Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228– 30 (2011), the United States Supreme Court ruled that the National Childhood Vaccine Injury Act preempts design defects – that they cannot be brought to state courts at all, even after going through the National Vaccine Injury Compensation Program (NVICP). The court reminded readers that the NVICP was intended as part of a compromise under which people claiming vaccine injury were given several substantial breaks that made their case easier, and manufacturers were given “significant tort-liability protections” aimed to stabilize the vaccine market. 

While the plaintiffs did not include the words “design defects” in their complaints, the court found that many of the claims in the complaint that plaintiffs tried to present as negligence or manufacturing defects were, in fact, design defect claims. For example, the plaintiffs tried to attack Gardasil’s ingredients, and the court found that “in challenging what is included in Gardasil – the Gardasil “recipe” – Plaintiffs are simply complaining about how Gardasil is designed.” Similarly, in trying to challenge the clinical trials’ design, and claiming inadequate testing, plaintiffs are also claiming the product was “defectively designed.”

For the manufacturing defect, too, plaintiffs claim that the “vaccines contained “ingredients and toxins that were not disclosed in the FDA-approved specifications and/or otherwise not disclosed in the package insert.”” As the court pointed out, a claim that the manufacturer used bad ingredients across the board is a design defect claim. A manufacturing defect claim is a claim that the product is a one-off and that it deviated from the planned design. 

Since the act preempts design defects, plaintiffs cannot bring these claims to civil courts, even if they call them something different, the court concluded. 

The plaintiffs’ other manufacturing defect claim, that there were unexpected ingredients, is contradicted by their own materials that show that the tiny amounts of DNA fragments they highlight under that heading were not an issue (“FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk”). As the court points out, this document is from 2011, before plaintiffs were vaccinated, so they cannot claim this was not known when they were vaccinated). So this, too, the court dismissed. 

Similarly, the vaccine act expressly bars direct warning claims by individuals, though it allows claims the doctor was not warned (assuming the doctor will provide the patient with needed information). It says

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.

Therefore, plaintiffs’ claims that Merck failed to warn plaintiffs of Gardasil’s risks were barred by the act. Of course, even without the act, given that extensive data goes against the claim that Gardasil causes these harms, these claims would be tricky, but they would be allowed to go forward, and the causation question would be decided later – as they were for the claims that Merck did not warn the doctors.

Those claims can continue, but proving causation is going to be challenging for plaintiffs. Further, even if causation was shown (which is unlikely), showing that Merck knew or should have known at the point the plaintiffs were vaccinated – in 2013-2015 – would be challenging. Plaintiffs would still have to show that for their claims that the doctors were not warned about these risks (that Gardasil likely does not have). 

Note that this still leaves other claims available – but there need to be valid claims of, for example, negligence and fraud. Something that the plaintiffs did not have. 

Claim not well-pled

Plaintiffs tried to claim fraud by Merck. But under law, plaintiffs claiming fraud need to clearly allege “who, what, when, where, and how” the fraud occurred – and plaintiffs do not. General, unspecified claims of fraud are just not enough. The claims that Merck omitted information in the direct representations the plaintiffs relied on are also not really fraud claims but repeat the lack of warning claims that, as explained above, the act bars. 

The last part of the fraud claims were claims of ““fraudulent concealment,” that is, the concealment by the omission of material facts that were reasonably calculated and intended to deceive and did in fact deceive a person, resulting in damages to the injured party” against the medical doctors that provided plaintiffs information about the vaccines.

The court points out that here, too, there are no specific allegations. Still, since the standard for fraudulent concealment is more lenient than for fraud generally, and since litigating those cases likely overlaps with the failure to warn claims against the doctors that the court allowed for now, these claims can continue. However, the court said this was a “close call”.

Summary

In rambling, long, and badly argued complaints (according to the court) plaintiffs tried to argue negligence, warning and manufacturing defect, and fraud in their Gardasil lawsuit. Without addressing the causation issue, the court found that the plaintiffs’ claims of negligence, manufacturing defects, and warning defects for themselves are barred by the National Vaccine Injury Compensation Act, and dismissed those.

Plaintiffs could have claimed negligence if they could point to valid negligence claims that were not “we think this design is sub-optimal” – but they did not do that, apparently unable to. The plaintiffs’ fraud claims were dismissed since they did not plead them specifically – they made general allegations of fraud, not spelled out properly. So what survives?

The plaintiffs can litigate the claim that Gardasil was defective because Merck did not properly warn the doctors of its risks, and overlapping that, Merck fraudulently concealed information from the doctors. 

To prove the warning defect, because Merck is claiming that such claims are preempted by the FDA label, and Merck can only warn doctors of “newly acquired information” without FDA approval – the plaintiffs would have to show that Merck had such newly acquired information supporting the risks plaintiffs are alleging it did not warn about. Otherwise, there is nothing it could give doctors. In addition, plaintiffs would have to show that Gardasil does, in fact, have the risks that Merck failed to warn about that it causes the alleged harms generally, something tricky given the scientific evidence, and that the vaccine did, in fact, cause it for the plaintiffs. 

For fraudulent concealment, the plaintiff will again have to show Merck has information that it did not provide, and also have to prove that Merck intentionally concealed this information, and again, that the information showed that Gardasil does have the alleged risks.

For both claims, plaintiffs would also have to show that if plaintiffs’ doctors had that information, plaintiffs would not have gotten the vaccines.

The claims left are much more limited than the broad conspiracy theory the complaint started with – and are not an easy lift. But they do give plaintiffs some chance at discovery and at getting some damages.

We will continue to track this litigation and report. 

Dorit Rubinstein Reiss

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