What the Lawsuits Claim
Gardasil, made by Merck, is a vaccine that protects against human papillomavirus (HPV), which causes cervical and several other cancers. A group of plaintiffs filed lawsuits alleging that Merck failed to adequately warn about certain claimed side effects — some pointing to conditions such as postural orthostatic tachycardia syndrome (POTS) or primary ovarian insufficiency. It is important to be precise: these are failure-to-warn claims. Under the Supreme Court’s decision in Bruesewitz v. Wyeth, plaintiffs cannot sue a vaccine maker for a product being “defectively designed” at all.
The alleged links to those conditions are contested and have not been established; public-health agencies and large studies continue to find the HPV vaccine safe and effective.
The Preemption Ruling
The federal cases were gathered into a multidistrict litigation. In March 2025, the judge overseeing it dismissed the majority of the claims on federal preemption grounds — concluding that Merck could not lawfully have added the stronger warnings the plaintiffs demanded, because the available science did not support them and federal vaccine law governs what warnings are allowed. Some plaintiffs are appealing. The ruling significantly narrows the litigation and underscores how hard it is to win vaccine cases in ordinary courts.
Vaccine-injury claims in the US generally run through a separate no-fault system, the National Vaccine Injury Compensation Program, rather than standard product-liability suits.
The Bigger Picture
The HPV vaccine is recommended by the CDC and health authorities worldwide and has been shown to sharply reduce HPV infections and pre-cancers. Coverage of lawsuits can create a misleading impression; here, the courts have largely rejected the claims. Anyone with questions about the vaccine should rely on their doctor and public-health guidance rather than litigation headlines, and be wary of sites that use the lawsuits to discourage a cancer-preventing vaccine.
Before You Act
Thinking About Filing a Claim?
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Gardasil Lawsuit: The HPV Vaccine Litigation Explained: Frequently Asked Questions
Answers to the most common questions about this case and your legal options.
What is the Gardasil lawsuit about?
Some plaintiffs allege Merck failed to warn about claimed side effects of the Gardasil HPV vaccine. These are failure-to-warn claims; design-defect claims against vaccines are barred by the Supreme Court's Bruesewitz decision.
Were the Gardasil lawsuits successful?
Largely no. In March 2025 the federal judge overseeing the MDL dismissed most claims on preemption grounds, finding Merck could not lawfully have added the warnings plaintiffs demanded. Some plaintiffs are appealing.
Is the HPV vaccine safe?
The CDC and health authorities worldwide recommend the HPV vaccine and find it safe and effective at preventing HPV infections and the cancers they cause. Discuss any concerns with your doctor.
Legal Disclaimer
This article is general legal information, not legal advice, and does not create an attorney-client relationship. Case status, eligibility criteria, and any amounts described are as reported at the date shown and may change. Consult a licensed attorney in your jurisdiction about your own situation.