Court dismisses Gardasil harms claims against Merck


This article about a court dismissing Gardasil harms claims against Merck 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 the social and legal policies of vaccination. 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 disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On March 15, 2022, a federal judge in Connecticut dismissed a tort claim brought against Merck by a young woman, Korrine Herlth, who alleged that the Gardasil vaccine caused her harm, including Postural Orthostatic Tachycardia Syndrome (“POTS”) and chronic fatigue syndrome (“CFS”).

The claim was dismissed on the grounds that federal law preempted most of the torts claims – they could not be brought because the Food, Drugs and Cosmetics Act said that federal law ruled these issues, not state torts law – and the others were dismissed because the plaintiffs’ claims were too general and did not provide sufficient grounds. The claims were dismissed without prejudice, so if the plaintiff – through her lawyers – can correct the problems the court identified, she can refile some of them. 

The case never reached the causation problems in the claim – causation problems that derive from the fact that multiple large studies found no link between HPV vaccines and the alleged harms. Nor did it actually get to examine the validity of the specific claims, but many of them draw directly from anti-vaccines claims that are highly problematic.

It is likely fair to say that in this case – and the other similar claims the law firm bringing the case, Baum, Hedlund, Aristel & Goldman is bringing alleging harms from Gardasil – the law firm is serving the anti-vaccine movement more than the individual plaintiffs, even if the law firm itself is not, as a whole, anti-vaccine. 

Merck Gardasil
Gardasil 9 from Merck

The Gardasil harms case against Merck

HPV vaccines were discussed by our host in multiple posts, and he has a collection of posts about the vaccines’ effectiveness and safety. Abundant evidence, as demonstrated in the articles our host posted about, shows that the risks of HPV vaccines are very small, and increasing evidence shows that the vaccines prevent cervical cancer, and we have reason to expect that it will prevent a variety of other cancers.

That said, nothing is without risks. Generally speaking, if someone was actually harmed by HPV vaccines, they should be quickly and generously compensated. That is part of the reason that we have a no-fault compensation program to compensate people.

And claimants have a right, after going through the program, to reject a decision – in their favor or against them – and go to the regular courts to try and get compensation. This is such a claim, and as I will discuss in the next section, one of a series of lawsuits brought by the same law firm against Merck, alleging similar claims. In addition, anti-vaccine activist Robert F. Kennedy Jr. is part of the lawsuits, and many of the claims sound like they were taken directly from the anti-vaccine statements against HPV vaccines. 

The facts are taken from the complaint, and at this point in the process, we assume that what the complaint alleged was true (It may be, but the complaint is basically – and is supposed to be – the plaintiff’s version, not an independent investigation, and without more investigation, needs to be treated as such).

Korrine Herlth received her first dose of the Merck Gardasil vaccine on October 2, 2013, and the second on December 2013. She was 15 years old and in good health. But, she alleges in the complaint, “after receiving her second dose of Gardasil in December 2013, Herlth began experiencing dizziness, shakiness, headaches, and nausea. She also experienced faintness, an elevated heart rate, and unsteadiness upon standing.”

Her mom decided not to give her the third dose of the vaccine. Her health deteriorated. She suffered from symptoms that included “daily seizures; vision, hearing, and balance problems; fatigue; anxiety and panic attacks; convulsions; sleep problems; depression; cognitive difficulties; numbness and tingling in her lower extremities; involuntary movements and tics; weakened connective tissue and chronic joint pain; and vaginismus and endometriosis.” She had to reduce her activities, ended up finishing high school online, and delaying college. Her diagnoses included postural orthostatic tachycardia syndrome (POTS) and chronic fatigue syndrome (CFS). She blamed the vaccine.

On January 13, 2016, she filed a claim with the National Vaccine Injury Compensation Program (NVICP), which was rejected on July 2, 2020, for “insufficient proof.” The decision in the case is very short and is in response to a motion to dismiss it by Ms. Herlth.

It’s unclear whether Ms. Herlth really could not accumulate evidence of causation (which would make going to state court, where she would also have to show causation, strange) or whether the case was only filed in vaccine court to go through the motions, and no effort was made to prove causation.

Leaning more towards the inability to make a case is a fact that in 2018 NVICP found reasonable Ms. Herlth’s request for $72,429.18 for lawyer fees ($50,160.50) and costs, including expert fees, suggesting work was being done at that point. (Petitioner was paid an additional $52,645.79 for lawyer fees and costs in 2020, but there most of the cost was lawyer fees, suggesting no further expert testimony was added). 

On March 30, 2021, Mr. Herlth filed the complaint dismissed in this decision. In the complaint, says the court, she makes several claims:

  1. Failure to warn (also called warning defect) — This is a claim that Merck did not appropriately warn her of a risk of Gardasil before she took the product.
  2. Manufacturing defect — this is a claim that usually alleges that the vaccine was manufactured in a way that deviates from its specifications or intended design. For example, the Cutter Incident, where a polio vaccine was supposed to be inactivated but was not, is an alleged manufacturing defect — the claim is that the vaccine was not manufactured in the way it was supposed to be according to the design plan.
  3. Negligence — Usually, a negligence claims alleges that the defendant acted unreasonably, and that unreasonable conduct caused the harm.
  4. Fraud against Herlth’s mother — Herlth alleged that two ads by Merck misled her mother into giving her Gardasil, and that the ads were fraudulent.
  5. Fraud against FDA — Herlth alleged that Merck misled FDA in the lead-up to the approval of Gardasil.
  6. Negligent misrepresentation — This is a claim that the defendant negligently made a false representation that plaintiff “reasonably relied” on, and therefore plaintiff suffered financial harm. 
  7. Common law fraud.

As background, the claims are brought in federal court because Herlth is from Connecticut, but Merck is incorporated in New Jersey. This means they are from different states, and parties from different states can appear before a federal court. However, when this happens, although the procedural rules are federal, the law applied by the court is usually state law.

In this case, the court is applying Connecticut law. Connecticut has a specific law about product liability called the Connecticut Product Liability Act (CPLA). The court is examining the claims under this act but has to consider whether federal law conflicts with it. If federal and state law conflict in an area in which the federal government has legal powers, federal law is supreme, and state law has to give way.

elegant diverse female business partners with documents talking on street
These are not attorneys litigating claims against Merck and Gardasil. Photo by Sora Shimazaki on Pexels.com

The lawsuits against Merck and Gardasil

It is important to put this complaint in the context of the widespread litigation effort against Gardasil, Merck’s HPV vaccine. The common point to all the claims is the involvement of Robert F. Kennedy Jr. And whatever the other lawyers are, RFK jr. is an anti-vaccine activist. Leading an anti-vaccine organization is currently his main occupation, and he is paid to do so.   Further, Mr. Kennedy has made untrue claims about HPV vaccines before.

Kenndy also repeatedly claims that vaccine makers have “zero” liability. He repeatedly alleged that there is no liability and manufacturers have been granted “blanket” immunity from liability for vaccines harms.  

This is inaccurate by itself, like the fact that this case was brought shows, and reiterating the claim while being involved in 14 lawsuits – at least – against vaccines manufacturers is highly problematic. 

The first lawsuit against HPV vaccines was brought on behalf of Jennifer Robi in 2016.   Robi’s claim in vaccine court was never supported by a medical opinion – and since her tort case does have them, it reads as if she went through NVICP just to check that box, always intending to go to state court. Robert F. Kennedy is one of her lawyers.

Robi claimed fraud, negligence, and failure to warn, among other things. Robi was diagnosed, among other things, with POTS. Her case is still ongoing. RFK jr. is part of her legal team, as is Michael Lin Baum, from Baum, Hedlund, Aristel & Goldman, the law firm bringing the rest of the cases.

The other 13 lawsuits were all filed by Baum, Hedlund, Aristel & Goldman.

These lawsuits raise a variety of claims, mostly for autoimmune issues. All the plaintiffs, from what I saw, claim POTS/CFS, many allege dysautonomia. One plaintiff alleges GBS, and a few allege ADEM. Although none of the cases got to this issue, a major problem facing the cases is that extensive data from all around the world failed to find a link between HPV vaccines and autoimmune diseases.

By and large, the claims for a link rely on very, very bad science from people who can fairly be described as, at least, anti-vaccine sympathetic.

But this issue is only going to be addressed after fact-finding, and that is a long time down the road. At this point, the question for the courts is whether the plaintiffs made enough of a legal claim to allow their case to go to fact-finding. The Robi court allowed the case to go forward; on the other hand, the Herlth court, at this point, did not.

People deserve their day in court, and it’s very realistic to think that several of these cases will proceed to fact-finding. In the meantime, anti-vaccine activists can use their mere existence to create fear, uncertainty, and doubt about HPV vaccines, as one of their tools to mislead people. 

The claims repeat each other across many of the claims and include several of the claims raised by anti-vaccine activists in the past, including claims in the anti-vaccine book about HPV I reviewed before. I will give three examples here.

One of the claims in the complaints (taken here from Herlth) is that the manufacturers misled FDA – committed fraud – by using as a control in the trial a solution that included tiny amounts of aluminum adjuvants. This is doubly misleading. First, it’s perfectly legitimate to use a vaccine solution without the active ingredient as the control; in fact, it may, in some cases, be the right control to preserve blinding.

Second, the FDA knew what was used in the different protocols. The complaint alleges that in the one study supposed to use saline, a carrier solution was used. This is one of the few things that are not clearly wrong from the documents; FDA’s review talks about a saline placebo, and I’m not sure whether this is an error, or they really did not realize the carrier solution was used, or they considered the carrier solution equivalent to saline because it had so little else. I would be inclined to the first or last, because the tiny amounts of other ingredients in the carrier solution would not make a large difference,  even though the complaint describes the carrier solution of the vaccine as a “witch’s brew”, and hiding something this meaningless would be, well, irrational.

The FDA knew that the majority of the subjects were given a solution containing aluminum adjuvants, and was not particularly concerned about it. This, by the way, is taken directly from the anti-vaccine book.

The complaint also used another anti-vaccine gambit, using one sub-group in which women who were exposed to HPV before being vaccinated had higher rates of cancer.

This is a misrepresentation – the women in the relevant group already had pre-cancerous lesions before the trial began, so went on to have cancer – something the vaccine wasn’t supposed to prevent. Later large studies found no such risk. And both of these claims are taken directly from anti-vaccine lore, covered in a misleading book about HPV vaccines by three anti-vaccine activists that I reviewed here. In fact, the complaint cites the anti-vaccine book as a source. 

Finally, taking a claim directly from the anti-vaccine book, the complaint alleges that “Merck cut the dose of aluminum adjuvant in half when it administered the vaccine to the nine to fifteen-year-old children in its protocol 018 study group.” As I explain in my review of the book, I emailed FDA to ask about this, and FDA confirmed that the table this claim is based on had a typo. A typo FDA was aware of.

Let me be clear — in my opinion, the law firms helping RFK jr. with these lawsuits are serving the anti-vaccine movement. They are bringing claims some of which come directly from the anti-vaccine movement, they are litigating cases of harms that science shows the vaccines do not cause, and they are working with an anti-vaccine leader to do so. Everyone deserves representation. But when you set out to find plaintiffs to create a large-ranging litigation campaign based on anti-vaccine claims, you are helping the anti-vaccine cause. And when you are helping anti-vaccine activists mislead people into thinking a vaccine that prevents cancer is dangerous, you are working to put people in harm’s way, and to increase cancer.

The claims in the complaints likely deserve more treatment, but I want to get to the decision. 

judges desk with gavel and scales
Photo by Sora Shimazaki on Pexels.com

The decision

The decision, generally, found three large issues with the complaint. Some of the claims were “preempted” – which means the state claims have to give way before a contradicting federal law, some of the claims were not sufficiently pled – they did not allege things specifically enough, and did not support their claims. 

Below are some of the key points to their decision:

Failure to Warn

Plaintiffs claiming failure to warn claim that the manufacturers – in this context – did not warn them of a potential risk of the product. 

The court found that because Gardasil’s warnings were on a label that had to be approved, with its exact text, by the FDA, the Food, Drug and Cosmetics Act’s labeling provisions preempt failure to warn claims. Simply put, Merck cannot add warnings to the product independently, and FDA is responsible for overseeing the warning.

The court found that an exception to the act that allows manufacturers to unilaterally change the label if “the changes “reflect newly acquired information” concerning contraindications, warnings, precautions, possible adverse reactions, or proper dosage and administration” did not apply, because the complaint did not provide evidence of “newly acquired information” causally connected to Ms. Herlth’s harm.

The judge pointed out that although the complaint claims Gardasil “increases the risk of fertility problems” and cancer (it doesn’t), these aren’t Ms. Herlth’s injuries, so it’s not relevant.

Articles published after Ms. Herlth got the vaccine are also not helpful to her claim – they would not be a basis for changing the insert and warning her, since they came about after she got her vaccine. The court points out that the complaint “cites nine articles that were published between 2006 and 2013. Aside from listing them, Herlth does not explain how these sources support her allegations. Upon review, some describe no more than a theoretical relationship between Gardasil and POTS, while others consist of case reports from individual patients. Several do not specifically relate to POTS or her other injuries, and others do not appear to specifically relate to the Gardasil vaccine.”

To keep this short, I’m not reproducing the full list – it’s in the complaint linked to in this post, in footnote 27. 

I am leaving out a discussion of another case the plaintiffs alleged changed the law, but in short, the judge pointed out that in that case defendant agreed that there was new evidence that could have led to a change in the label. 

The plaintiffs also tried to argue that because one kind of claim – design defects – are expressly preempted under our Supreme Court jurisprudence, all other claims stand. That, too, was rejected by the court, which concluded that Supreme Court jurisprudence upholds usual preemption claims in that situation. 

Manufacturing defect

A manufacturing defect claim alleges that the product did not meet the manufacturer’s intended design. In other words, it’s a claim that the product’s manufacturing was sub-standard according to what the manufacturer himself was planning. 

The problem with these claims is that “the amended complaint alleges various ways in which Gardasil is unreasonably dangerous, but it does not allege that the Gardasil doses that Herlth received deviated either from their manufacturer’s intended result or from run-of-the-mill dosages of Gardasil vaccine.”

Basically, the complaint is alleging Gardasil generally contains ingredients the plaintiff – or her lawyer – thinks are an issue, but does not claim that the ingredients are the result of a  problem in the manufacturing process. The judge – correctly, in my view – identifies the complaint as claiming a design defect – the claim that the product’s design was inherently flawed, or too dangerous – masquerading as a manufacturing defect.

They want to claim Gardasil is dangerous because it has bad ingredients (a claim routinely found in anti-vaccine circles, usually with no basis). The problem for them is that design defects claims cannot be brought in state or federal courts; they’re limited to NVICP. Plaintiff’s lawyers tried to get around that by pretending the claims were manufacturing defects claims – but they were not. 

Negligence

The decision criticizes the complaint about the way this was addressed, saying that it “lumps a number of disparate theories of product liability under the general header of “negligence.”

According to Herlth, Merck breached its duty of reasonable care in “design, research, manufacture, advertisement, supply, promotion, packaging, sale, and distribution of Gardasil.” I have difficulty discerning from Herlth’s sprawling and conclusory allegations and subsequent briefing the precise nature of her negligence claim.” The court concluded that the plaintiff’s lawyers were trying to mask claims of warning, manufacturing, and design defects as negligence, and that isn’t going to work. The other claims, said the court, fit fraud better. 

Fraud

The judge was willing to assume that Connecticut’s product liability law does not preempt fraud claims. But the claims here were problematic, and more so because they had to meet a high standard. Under the federal rules of civil procedure, there is a special heightened pleading for claims of fraud or intentional misrepresentation.

Our jurisprudence clarified that complaints raising fraud must specify the statements that are allegedly fraud, identify the speaker, state where and when the statements were made, and explain why the statements were fraudulent. The malic and intent need to be alleged less, but there needs to be enough facts to  “’…give rise to a strong inference of fraudulent intent.’ Lerner v. Fleet Bank, N.A., 459 F.3d 273, 290 (2d Cir. 2006).” 

The fraud claims in the complaints don’t set out any fraudulent statements specifically – it alleges “incomplete warnings and instructions”, which the judge, correctly, points out is similar to the failure to warn claim, which cannot be brought because of preemption. While the complaint also mentions Merck “statements it made in its publications, ubiquitous television advertisements, billboards, print advertisements, online advertisements and website, and other written materials intended for consumers, patients, parents of minor-aged patients, medical providers, and the general public, that Gardasil was safe and effective at preventing cancer” it only specifically sets out two statements – and neither of them works.

These are two claims from Merck ads. One is from a campaign that started in 2016 – “Mom, Dad, Did you Know?” – and since that’s after Herlth got her vaccine, it could not mislead her mom into getting it for her. The other is from Merck’s “One Less” campaign that predated Herlth getting the vaccine. But here, too, the complaint does not meet the required standards. Herlth takes issue with the ads suggesting that Gardasil prevents cervical cancer, and argues that it did not mention side effects (though elsewhere, the judge points out, she points out that the ad did mention side effects).

The judge also points out that the complaint itself points out that preventing cervical cancer was one of the vaccine’s “approved indications”. Based on that, the judge concluded that the complaint did not set out – allege – any specific statements made with “knowing falsity” – but a “perfectly ordinary advertisement, highlighting a. product’s strengths while deemphasizing its weaknesses.” That’s not enough to go forward on a fraud claim, the judge concludes.

The complaint also does not really allege a specific motive for fraud. Just saying a for-profit company has a general profit motive,  says the court, is not enough to be an allegation of intent to defraud. 

The fraud claim against medical providers also does not show marketing directed at Herlth’s pediatrician or that the pediatrician acted on any misrepresentations. So that, too, is not properly alleged.

The fraud claims directed at FDA – including claims that an improper placebo was used – were also not alleged specifically, said the judge because the complaint did not say “where, when, and how” the alleged misrepresentations were given to FDA, and she did not provide evidence that allows us to infer fraudulent intent. 

Maybe more important – pleadings may, perhaps, be fixable, if you have information to fix them, but this is not – the Court pointed out that state law claims to allege fraud against the FDA was, according to the Supreme Court, preempted by the Food, Drug, and Cosmetics Act. The court relied on Buckman Co v. Plaintiffs’ Legal Comm, from 2001. Buckman concluded that it’s the federal government that gets to enforce a violation of disclosure requirements and anti-fraud provisions in the Food, Drug, and Cosmetics Act, not private litigants alleging fraud against the FDA.

Therefore, fraud against the FDA cannot be brought up as a claim in state court. 

Negligent misrepresentation

Negligent misrepresentation covers situations where the defendant misrepresented a fact that the defendant should have known, the plaintiffs relied on the misrepresentation and suffered monetary harm. But here, the negligent misrepresentation claims were “nearly indistinguishable” from Ms. Herlth’s claims of fraud, and based on the same acts. Therefore, they are held to the same standard as the fraud claims – and fail it. 

Common law fraud

The court found that this was not a separate claim from the product liability and fraud claims above. 

Conclusion

The court dismissed Ms. Herlth’s claim as both preempted by federal law and not sufficiently well-pled. Probably the most meaningful part of the decision for other cases is the court’s conclusion that fraud claims against the FDA cannot be raised in state torts claims, because they are preempted.

Since claims that Merck committed fraud against FDA are a large part of the complaints against HPV vaccines, if other courts follow these, the claims are going to struggle – long before getting to causation. The court dismissed the case without prejudice, giving the plaintiff a chance to amend the complaint to allege facts that will solve the problems highlighted. Plaintiff can probably do that for some of the claims, but not others, and the complaint’s most important claims – coming directly from the HPV anti-vaccine book, and focusing on alleged fraud by Merck against FDA – will still face the preemption problem. 

Dorit Rubinstein Reiss
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