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 Act1, 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After all vaccine court claims were either rejected or voluntarily withdrawn, more than 200 claims were filed in various federal district courts against Merck, which were then consolidated in a multidistrict litigation.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...
