Gardasil Settlement Will Result in $50M Payout by HPV Vaccine Manufacturer

Agreement to include about 200 cases involving POTS and POI injuries originally dismissed last year for being preempted by federal law.

Merck & Co. has announced a settlement agreement that would pay $50 million to resolve more than 200 Gardasil lawsuits alleging that the HPV vaccine’s side effects have caused serious neurological and other adverse health problems.

The Gardasil settlement was announced by Bloomberg News on June 4, indicating that the information came from a statement emailed by Merck officials following years of litigation. Merck has claimed that the settlement will completely end all litigation except for one remaining case.

First introduced in 2006, Gardasil is a widely used vaccine administered to young girls and boys for the prevention of human papillomavirus, or HPV, infections, which can cause cervical cancer and other forms of cancer. HPV is sexually transmitted, and the vaccine has been promoted as an important tool for preventing HPV-related cancers later in life.

Gardasil has been approved for use in about 150 countries, with more than 900 million injections given worldwide over the last 20 years.

Despite the company’s claims that the vaccine is safe, Gardasil side effect lawsuits have been filed over postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency (POI), premature menopause, seizures and other autoimmune disorders, which allegedly emerged shortly after patients received the injections. These allegations resulted in hundreds of claims being filed nationwide by former Gardasil recipients and their families.

All claims filed in federal court involving the vaccine’s alleged side effects have been consolidated in the Western District of North Carolina since August 2022, before U.S. District Judge Kenneth D. Bell for coordinated discovery and pretrial proceedings.

The litigation was originally expected to include a series of bellwether trials, which are designed to test the strengths and weaknesses of the parties’ evidence before actual juries and help guide potential settlement negotiations.

However, as the bellwether trials were being prepared, Merck filed a motion for summary judgment in early March 2025, asking the court to dismiss many of the claims before trial. Judge Bell agreed that the Gardasil manufacturer should be immune from state law-based failure to warn claims involving POTS and POI injuries, which made up the majority of claims in the litigation, determining that those claims were preempted by federal law.

The ruling effectively removed many of the central claims from the Gardasil MDL, finding that plaintiffs could not pursue warning-based allegations under state law because the claims conflicted with the federal regulatory framework governing vaccine labeling. Last July, the plaintiffs whose cases were dismissed filed an appeal with the U.S. Court of Appeals for the Fourth Circuit, but the appeals court rejected the motion in September.

According to Bloomberg’s report, the dismissed POTS and POI cases will be included in the $50 million Gardasil settlement, which will address more than 200 total claims. The manufacturer first reported a potential settlement in its annual earnings report in February, indicating at the time that the deal would only be finalized if enough Gardasil plaintiffs approved the agreement.

Merck indicates the agreement is not a confession of liability, stating that the settlement is significantly cheaper than continuing to defend every lawsuit in court. The company has maintained that Gardasil remains safe and effective, and that it stands behind the vaccine’s safety profile.