Merck & Co. agreed in June 2026 to pay more than $50 million to settle over 200 Gardasil lawsuits, including claims that the HPV vaccine caused infertility, autoimmune disorders, and other injuries.1Bloomberg News, June 2026 The Gardasil lawsuit infertility settlement resolved nearly a decade of U.S. litigation, but Merck did not admit that the vaccine caused any of the alleged harms, and the deal came only after federal courts had already dismissed the bulk of the cases.
What the Infertility Claims Alleged
The infertility side of the litigation centered on primary ovarian insufficiency, sometimes called premature ovarian failure or premature menopause. It refers to a loss of normal ovarian function before age 40. Reports of young women developing the condition after HPV vaccination began circulating around 2012, starting with a published case involving a single 16-year-old girl.
Plaintiffs offered two theories. The first was autoimmune: because some POI cases have autoimmune origins, lawyers argued that Gardasil’s ingredients could trigger the immune system to attack the ovaries. The second focused on the vaccine’s aluminum-based adjuvant, amorphous aluminum hydroxyphosphate sulfate (AAHS). Citing animal research suggesting aluminum can accumulate in ovarian tissue and suppress reproductive hormones, plaintiffs argued Merck never adequately tested whether AAHS was safe for the reproductive systems of adolescent girls. They also pointed to gaps in Merck’s original preclinical fertility study in rats, which never produced ovarian histology reports for vaccinated animals and did not test a full three-dose course before mating.
A 2020 analysis of FDA adverse-event reports found a statistical association between the older Gardasil formulation and POI-related events such as amenorrhea and premature menopause. The authors cautioned that the data came from a passive reporting system and did not confirm causation.
What the Science Says
Major health authorities have consistently concluded that Gardasil does not cause infertility. A Kaiser Permanente study published in Pediatrics in 2018 followed nearly 200,000 females and identified only 28 cases of POI, just one of whom had received the HPV vaccine before symptoms appeared. A nationwide Danish cohort study of nearly one million women, published in JAMA Network Open in 2021, found no association between HPV vaccination and primary ovarian insufficiency. The World Health Organization’s Global Advisory Committee on Vaccine Safety, reviewing the evidence through 2020, described the vaccine’s safety profile as “extremely favourable.” An FDA postmarketing safety review of Gardasil 9 covering 2014 through 2017 identified no new safety signals.
This scientific record shaped the litigation. It made expert testimony harder to sustain and gave judges a strong evidentiary basis for the rulings that followed.
Why the Cases Collapsed Before Settlement
The federal cases were consolidated in August 2022 into a multidistrict litigation, MDL No. 3036, In re: Gardasil Products Liability Litigation, before Judge Kenneth D. Bell in the Western District of North Carolina. A total of 258 cases were filed. Alleged injuries included POI, postural orthostatic tachycardia syndrome (POTS), complex regional pain syndrome, Guillain-Barré syndrome, and other autoimmune and neurological conditions.
Plaintiffs faced structural hurdles from the outset. Under the National Childhood Vaccine Injury Act of 1986, anyone claiming injury from a covered vaccine must first file a petition with the federal Vaccine Injury Compensation Program before suing the manufacturer. And the Supreme Court’s 2011 decision in Bruesewitz v. Wyeth had already established that the Act preempts design-defect claims against vaccine makers, leaving only failure-to-warn and manufacturing-defect theories available.
In March 2024, Judge Bell dismissed manufacturing defect, design defect, failure to warn patients directly, and general negligence claims. Only failure to warn medical providers and fraudulent concealment directed at providers survived.
The decisive ruling came on March 10, 2025, when Judge Bell granted summary judgment for Merck, dismissing more than 200 lawsuits at once. He held that federal law preempted the remaining failure-to-warn claims because Merck lacked the authority to unilaterally change its FDA-approved label. He noted that after more than 100 million doses had been administered worldwide, the published literature by 2013 contained only one verified case of POTS and four of POI linked to the vaccine. “No scientist could reasonably conclude there is a causal association based on this paucity of evidence,” the judge wrote.
A final judgment dismissing the remaining POTS claims followed in late June 2025. On September 4, 2025, the Fourth Circuit affirmed the dismissal of three bellwether cases in a published opinion. Chief Judge Diaz wrote that “timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit,” and that district courts have no authority to second-guess a special master’s timeliness determination in the Vaccine Court.
What Plaintiffs Actually Receive
In early June 2026, Bloomberg News reported that Merck had reached a deal to resolve the Gardasil litigation in its entirety, with the exception of one remaining case. The agreement covered more than 200 individual lawsuits, including the previously dismissed federal cases and a pending state trial in Los Angeles, for a total of more than $50 million.
Merck did not admit liability. The company called the payout “not material” to its finances and “considerably less than Merck’s anticipated costs” of continuing to defend the cases through trial. The deal was contingent on a sufficient number of plaintiffs signing on.
The math matters for anyone weighing the outcome. With more than 200 cases splitting roughly $50 million, average per-plaintiff recovery was far below the six- and seven-figure amounts plaintiff law firms had projected earlier in the litigation for conditions like premature ovarian failure or POTS. For a settlement that resolves almost every remaining U.S. Gardasil case, this is the practical ceiling.
If You Believe Gardasil Injured You
The civil settlement is closed to new plaintiffs, and the courtroom path outside the Vaccine Court is essentially shut. The Fourth Circuit’s ruling makes clear that a timely filing in the federal Vaccine Injury Compensation Program is a prerequisite before any tort suit against Merck can proceed, and district courts cannot revisit a special master’s timeliness call.
The VICP itself has paid Gardasil claims. Between 2006 and 2018, the program received 333 claims related to HPV vaccine injuries, and 142 of those qualified for compensation. In one 2017 case, a client who developed neuromyelitis optica after vaccination received an $11.5 million lifetime settlement through the program. Filing a petition there, within the program’s deadlines, is the mechanism that remains.
As the litigation wound down, some advocates turned to bipartisan proposals to reform the VICP and revisit the liability protections that the 1986 Act provides to vaccine manufacturers. Whether those reforms move forward will shape what future claimants can pursue; for now, the 1986 framework and the June 2026 settlement together define the landing point.