According Merck, this settlement resolves all but one of the pending lawsuits filed against its HPV vaccine.1

Gardasil was fast-tracked to licensure by the U.S. Food and Drug Administration (FDA) in 2006 and first recommended by the U.S. Centers for Disease Control and Prevention (CDC) to be given to all 11-12-year-old girls. It was known at the time that Merck used an aluminum containing bioactive "placebo" in pre-licensure trials and only tested the vaccine in a small number of children under age 15.2

History of Gardasil Lawsuits

The 200-plus lawsuits filed since 2022 were consolidated into one class action case involving plaintiffs came from across the country stating that the vaccine caused serious injury and chronic poor health, including autoimmunity, encephalitis and neurological dysfunction, Postural Orthostatic Tachycardia Syndrome (POTS), development of diabetes, premature ovarian failure (POI), infertility, and death.3 The class action lawsuit alleged manufacture defect, failure to warn and negligence.4

Plaintiffs alleged that the drug company failed to "exercise ordinary care" in the research, development, distribution and marketing of Gardasil. They also point out that Merck did not use a saline placebo in pre-licensure trials and instead used a bioactive neurotoxic placebo, as well as failed to adequately test the vaccine in the targeted age group.5

Plaintiffs further alleged that Merck exaggerated the benefits of Gardasil and failed to properly disclose the adverse events. They claim that Merck knowingly failed to warn both doctors and the public about Gardasil's true risk of injury and death. Plaintiffs state that Merck intentionally engaged in a "relentless propaganda campaign" with the intent to guilt and scare parents into giving their children the vaccine despite the lack of studies showing that Gardasil prevents cancer.6

Merck Granted Summary Judgment to Dismiss Case

In March 2025, the District Court in North Carolina sided with Merck and granted a summary judgment motion to dismiss plaintiff's failure to warn claims in ongoing litigation between the pharmaceutical giant and young women injured by the Gardasil vaccine. Merck filed a summary judgment motion to dismiss the failure to warn claims as it pertained to the vaccine causing POTS and POI. A summary judgment motion is brought when one party alleges that a trial is not necessary as the other side has no valid claims or defenses for the judge or jury to consider. The moving party argues that they are entitled to a judgment as a matter of law due to there being "no genuine issues as to any material fact."7

The court concluded that there was not enough evidence to prove that there was a causal connection between the administration of the vaccine and those poor health outcomes. Since the court determined that Merck did not have newly discovered causation evidence, then FDA approval would be needed to change the vaccine label. Accordingly, the court found that Merck lacked the authority to independently add a new warning to the vaccine's label.8

In July 2025, Plaintiffs appealed the decision arguing that the court erred in excluding key witnesses and in dismissing the case.9 The U.S. Supreme Court declined to hear the case in March 2026.10