Not only is it clear that warnings must not be added if there is not substantial evidence to support additional warnings post-FDA review, but it is also clear that over-warning is taken very seriously. 

On March 11, 2025, Judge Kenneth Bell in the Western District of North Carolina granted summary judgment in favor of Merck & Co. Inc. and Merck Sharp Dohme LLC (together “Merck”) against the “bellwether plaintiffs” in a multidistrict litigation who were vaccinated with Gardasil at various dates from 2012 to January 2021.

Background

Merck designed and manufactured Gardasil to prevent cervical and other cancers caused by the human papillomavirus (HPV). The Food and Drug Administration (FDA) originally approved Gardasil in 2006, then again in 2014 when Gardasil 9 was introduced, which provided protection over more strains of the virus than the original vaccine covered. These vaccines have been administered over 135 million times in the United States and 500 million times worldwide. Despite overarching efficacy of Gardasil in preventing HPV and the resulting cancers, some recipients have claimed they developed postural orthostatic tachycardia syndrome (POTS) or primary ovarian insufficiency (POI) due to the vaccine.

Because Gardasil is a childhood vaccine covered by the Vaccine Act[1], original claims were filed in the vaccine court against the Secretary of Health and Human Services, a process “designed to work faster and with greater ease than the civil tort system.”[2] Health and Human Services, which oversees both the FDA and Centers for Disease Control, argued against allegations of an association between Gardasil and POTS or POI, stating that “the only reliable epidemiological evidence” supports that “there is no known association between HPV vaccination and the development of POTS [or POI].”[3]

After all vaccine court claims were either rejected or voluntarily withdrawn, more than 200 claims were filed in various federal district courts against Merck, which were then consolidated in a multidistrict litigation. This approach prioritized “discovery and dispositive motions on general causation and implied preemption.” Applying the Vaccine Act, the court dismissed plaintiffs’ (1) “direct warning” claims that Merck failed to properly warn plaintiffs and their parent(s); (2) “design defect” claims (including claims based on Gardasil’s ingredients and clinical trials); (3) “manufacturing defect” claims; and (4) claims of fraud on medical providers.[4] State law claims remain, alleging Merck failed to properly warn and fraudulently concealed material facts from medical providers on POTS and POI.[5]

Ruling

Merck’s summary judgment motion required the court to decide whether plaintiffs’ state law claims were preempted by federal law. Federal law impliedly preempts state law “where it is ‘impossible for a private party to comply with both state and federal requirements.’”[6]

The court found that Merck met this standard, and plaintiffs did not successfully rebut its claims.

First, the court reviewed reports from the Vaccine Adverse Event Reporting System, which detects potential signals of safety issues with U.S.-licensed vaccines, as well as other adverse event reports received from any other source, which could include self-reported adverse events from healthcare providers, patients and others. Only 10 reports regarding Gardasil and POTS came through from June 2006 and January 2011 as well as 10 reports from Merck itself in that period, which fails to show potential causation given the tens of millions of individuals who received Gardasil.

Second, the court looked at “published case reports” and “case series” from which the plaintiffs’ expert pulled just one published report of a POTS case from after its 2006 submission to the FDA. In 2010, a foreign scientific journal published one case report describing a 20-year-old woman who developed POTS two weeks after her first Gardasil dose, which the plaintiffs’ expert lauded for its temporal association between vaccination and POTS onset. Since temporal association alone does not equate to “causal association,” the court dismissed this report, citing the large number of unaffected recipients prior to January 2011.[7]

The court then reviewed other scientific literature plaintiffs submitted, which their expert claimed could potentially reflect “newly acquired information.” This amounted to only two reports: (1) a 2009 post-marketing review of reports following administration that conflated autoimmune diseases generally with POTS or POI and did not specifically mention either disease and (2) a 2009 editorial in a scientific journal advocating for more extensive discussion on potential adverse events with patients, again without mention of POTS or POI. As neither even mentioned POTS or POI, this evidence did not establish a causal relationship between the vaccine and acquiring these diseases.

Based on the lack of evidence demonstrating a causal association between Gardasil and POTS or POI, the court granted Merck’s summary judgment motion, stating that allowing a warning on the vaccine’s label “would effectively make the regulatory standard [on warnings] meaningless.”[8]

Broader Effect

The decision underscores the supremacy of federal law over state law claims as it relates to FDA-approved warnings. Not only is it clear that warnings must not be added if there is not substantial evidence to support additional warnings post-FDA review, but it is also clear that over-warning is taken very seriously. The court highlights that “FDA regulations seek to provide what may be best described as the ‘Goldilocks’ amount of information; that is, ‘just right’—not too little and not too much.”[9] The court is clear that over-warning on approved products “may deter appropriate use of medical products or overshadow more important warnings.”[10]

Based on this ruling, biotechnology and pharmaceutical companies have additional support that an increase in adverse events does not automatically trigger a warning update for FDA approved medications.

For More Information

If you have any questions about this Alert, please contact Sean K. Burke, Gabrielle Pelura, any of the attorneys in our Products Liability and Toxic Torts Group or the attorney in the firm with whom you are regularly in contact.

Notes

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