Gardasil Vaccine Lawsuit Dismissal Appealed to the U.S. 4th Circuit Court of Appeals

Appeal challenges several rulings in the case, including the MDL judge’s exclusion of a key expert witness that linked side effects of the HPV vaccine to neurological and autoimmune disorders.

The U.S. Court of Appeals for the Fourth Circuit will hear a challenge to the dismissal of about 200 Gardasil lawsuits, which claim that the widely used HPV vaccine left children and young adults with devastating neurological and autoimmune disorders, requiring the parties to file opening briefs next month.

Gardasil has been administered to young girls and boys worldwide over the past decade, as a prophylactic vaccine against human papilloma virus (HPV) infections, which can lead to the development of cancer. However, the claims against Merck alleged that the manufacturer failed to adequately disclose the risks of serious adverse health effects, including postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency (POI) and other injuries.

Nearly three years ago, the litigation was consolidated as part of a Gardasil MDL (multidistrict litigation), centralizing claims brought throughout the federal court system in the Western District of North Carolina, where U.S. District Judge Kenneth D. Bell was presiding over coordinated discovery and pretrial proceedings.

As the parties were preparing to hold a series of early bellwether trials slated to begin next year, which would test the strength of each side’s evidence and testimony before a federal jury, Judge Bell issued a controversial ruling excluding plaintiffs’ expert witnesses from testifying at trial.

Merck filed a motion for summary judgment in November 2024, claiming the litigation was preempted by federal law. The vaccine manufacturer argued that they should be immune from liability for failing to warn about the Gardasil side effects, since it did not have the scientific evidence necessary to convince the U.S. Food and Drug Administration (FDA) to update the label warnings.

On March 11, Judge Bell issued a court order granting Merck’s motion in early bellwether cases, opining that the evidence linking Gardasil and POTS was insufficient to allow the claims to move forward. As a result of the ruling, the Court issued a Final Judgment (PDF) late last month, dismissing all remaining Gardasil lawsuits involving POTS injury claims.

Plaintiffs File Gardasil Vaccine Lawsuit Appeal

On July 11, Gardasil vaccine lawsuit plaintiffs filed a Notice of Appeal (PDF) with the U.S. Court of Appeals for the Fourth Circuit, challenging Judge Bell’s rulings to exclude a key plaintiffs’ expert witness needed to prove causation, and granting the defendants motion for summary judgment on preemption grounds.

The plaintiffs’ appeal also argues Judge Bell wrongly denied a motion by the bellwether plaintiffs filed on June 27, asking that the ruling be limited to a partial judgment, as well as other decisions leading up to the dismissal.

In a briefing order (PDF) issued on July 16, the Fourth Circuit appeals court announced it was agreeing to review the case and called for a joint appendix and opening briefs to be submitted by August 25, and response briefs to be filed by September 24, 2025. The rest of the order includes detailed instructions on how the briefs are to be filed.

The court has not yet decided whether oral arguments will be necessary, indicating that it could decide the appeal on the briefs alone. The order notes that lawyers for both sides will be notified beforehand if oral arguments are deemed warranted.

If the plaintiffs’ appeal is successful, it would likely result in the claims being reinstated and Gardasil bellwether trials moving forward. However, a ruling in either direction could result in attempts to appeal the decision to the U.S. Supreme Court, meaning the continuance of the litigation could be delayed for some time.