Plans During Gardasil HPV Vaccine Lawsuit Appeal Outlined by Parties

Although a recent Court order is expected to result in the dismissal of Gardasil lawsuits involving POTS or POI, parties indicate there are nearly 100 claims involving other injuries.

Following a controversial ruling issued last month by the U.S. District Judge presiding over all Gardasil lawsuits, which found that claims involving postural orthostatic tachycardia syndrome (POTS) and primary ovarian insufficiency (POI) are preempted by federal law, the parties have each submitted letters outlining how the Court should handle the litigation while that ruling is appealed.

Gardasil is a widely used vaccine given to young girls and boys, as a prophylactic against the development of human papilloma virus (HPV) infections, which can be sexually transmitted and can lead to the development of cancer.

Although it has been promoted as a safe and effective vaccine, Merck has faced more than 200 lawsuits brought by individuals throughout the U.S., each raising similar allegations that the manufacturer failed to adequately warn recipients about the risk of serious life-changing autoimmune complications.

Before the first “bellwether” claims went to trial, which were intended to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims, the federal judge overseeing the litigation issued a ruling on March 11, indicating that certain Gardasil failure to warn lawsuits will be dismissed, since plaintiffs cannot establish a connection between the vaccine and POTS or POI.

Plaintiffs have indicated they intend to pursue an appeal of the ruling, raising questions about how the Court should handle claims involving other injuries. In addition, new Gardasil lawsuits are likely to continue to be brought by former users over the coming months, while the issue is addressed by the appellate court.

Given common questions raised in the litigation, all of the HPV vaccine lawsuits against Merck have been consolidated as part of a Gardasil MDL (multidistrict litigation) since August 2022, with cases brought throughout the federal court system centralized before U.S. District Judge Kenneth D. Bell, Sr. in the Western District of North Carolina, for coordinated discovery and pretrial proceedings.

As the parties were preparing a group of “bellwether” lawsuits for early trial dates, Merck filed for summary judgment in early March 2025, and Judge Bell agreed that the Gardasil manufacturer should be immune from state law-based failure to warn claims for POTS and POI injuries, which make up the majority of claims involved in the litigation. 

Judge Bell found that the claims are preempted, since federal laws would have prevented the drug maker from strengthening the warning label, and plaintiffs immediately announced intentions to pursue Gardasil lawsuit appeals to challenge the ruling, which could effectively end the litigation. 

On April 8, letters were simultaneously sent to Judge Bell by plaintiffs (PDF) and defendants (PDF), which outline their respective positions on how the MDL should handle remaining cases while the appeal is pursued.

The parties indicate that they agree Judge Bell should issue a final judgment on the 16 bellwether cases involving POTS and POI injuries, as well as other non-bellwether claims that also include those injuries, so that a single Gardasil appeal can be pursued on behalf of these claimants.

According to Merck, about 127 plaintiffs involved in the litigation currently allege POTS or POI injuries. However, the parties have agreed that they will confirm the list of impacted cases by April 15. The parties will then file a joint stipulation by April 22, identifying the non-bellwether POTS and POI injury claims.

“Due to the appeal that will ensue following judgment entry, the parties are in negotiations regarding a stipulation addressing this Court’s decision to apply this preemption Order to the additional Plaintiffs who also allege POTS and POI injuries. The parties are working on a stipulation that fully protects these non-bellwether POTS and POI Plaintiffs’ appellate rights and prevents any waiver of their appellate rights,” the plaintiffs’ letter states. “In this way, all cases that are directly implicated by the Court’s order will be appellants for one appeal at this time, rather than a procedure that might result in many appeals that are necessary at a later time.”

Non-POTS or POI Gardasil Injuries

Lawyers noted there are nearly 100 plaintiffs who have alleged various injuries different from POTS and POI, including: 

Plaintiffs argued that those cases should be stayed until a decision is returned on their Gardasil lawsuit appeal, which will be considered by the Fourth Circuit Court of Appeals. 

According to their letter, how the Fourth Circuit rules on the appeal will give the parties and the Court guidance on how Judge Bell’s ruling affects those other claims.

Merck has objected to the request for a pause on the remaining claims, calling for the Court to “continue to prioritize the dispositive issue of federal implied preemption” and move forward with a plan to resolve the other cases while waiting on the Appellate Court’s decision.