Merck Seeks To Have Gardasil Lawsuits Dismissed, Alleging Plaintiffs Cannot Prove Causation

Merck & Co. has filed a series of motions in response to Gardasil lawsuits brought by individuals who developed various neurological and autoimmune injuries, asking the judge presiding over the litigation to exclude plaintiffs’ expert witnesses from testifying at trial about the potential side effects of the HPV vaccine.

There are currently more than 200 product liability lawsuits filed against the drug manufacturer throughout the federal court system, each raising similar allegations that Merck failed to disclose potential side effects of Gardasil, which has been widely promoted for use among both young girls and boys to aid in the prevention of human papillomavirus (HPV) infections that may lead to the development of cervical cancer.

Plaintiffs claim that Merck knew or should have known about the risk that some users would develop postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocytopenic purpura (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other injuries.

Since August 2022, the claims have been consolidated as part of a federal Gardasil vaccine MDL (multidistrict litigation), where U.S. District Judge Kenneth D. Bell, Sr. is presiding over coordinated discovery and pretrial proceedings in the Western District of North Carolina.

Last last year, Merck filed a motion to dismiss Gardasil lawsuits based on claims they are preempted by federal law. The company argues the FDA would not have approved label changes without that evidence, and that the FDA’s labeling requirements supersedes failure to warn lawsuits filed under state lawsuits.

However, Merck also filed a motion seeking to exclude the plaintiffs’ causation expert witnesses (PDF) on January 6, which would effectively prevent claimants from proving that Gardasil caused their injuries at trial. Together with the request to prevent juries from considering the testimony, Merck also filed a motion for summary judgment (PDF), arguing that without expert testimony, the plaintiffs will be unable to establish general causation.

The details of the memorandums to support the dismissals were sealed under court order.

Last year, Judge Bell ordered the parties to select 16 Gardasil bellwether lawsuits to undergo case-specific discovery and preparations for a series of early trial dates, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

If Judge Bell finds any of the plaintiffs’ experts can proceed with testimony and does not dismiss the claims, the court is later expected to narrow the 16 selected claims down to a smaller group that will likely be prepared to go to trial near the end of 2025 or the beginning of 2026.

While the amount of any damages awarded in the bellwether cases will not have any binding impact on other Gardasil claims, the trials will be watched closely to see how juries rule, and whether they hit Merck with large financial penalties for failing to adequately warn about the potential Gardasil side effects.