Merck to Settle Bulk of Gardasil Suits for About $50 Million

Merck & Co. says it will settle a spate of lawsuits that blame the drugmaker’s blockbuster Gardasil cancer vaccine for causing autoimmune ailments that affect young women’s hearts and reproductive systems for an amount that is “not material” to the pharma firm.

Gardasil prevents human papillomavirus, or HPV infections. Under the accord, Merck would pay more than $50 million to settle more than 200 cases, according to people familiar with the matter. The deal would also resolve a closely watched case set for trial next month in state court in Los Angeles.

Merck, based in Rahway, New Jersey, said in an emailed statement to Bloomberg News that it decided to “end the litigation in its entirety” by settling all the Gardasil litigation — except for one case. The company added that research and evidence “continues to support the safety and efficacy of our HPV vaccines.” Researchers have tied HPV infections to cervical cancer.

In mass-injury litigation like the Gardasil cases, companies can agree to pay a group of people claiming a product hurt them to resolve cases without saying that the product was harmful. Merck isn’t admitting liability as part of settlement, said the people, who asked not to be identified discussing details that remain private.

An attorney in the Los Angeles case involving Jennifer Robi, a California woman who contended Gardasil she got as a teenager caused a heart ailment that’s left her in a wheelchair, declined to comment. Her case could have been the first against Merck over the vaccine to be decided by a jury.

The vaccine has been approved for use in about 150 countries since it was introduced 20 years ago and Merck says more than 900 million doses of its Gardasil and Gardasil 9 products have been distributed worldwide. Mainstream medicine has heralded it as safe and effective for decades. Merck has steadfastly denied the shot causes dangerous side effects.

In its annual report in February, the company said it had “entered into a proposed agreement” in October to end the litigation that required additional steps to finalize. Merck officials said the deal only would be consummated if enough people who had received Gardasil signed on.

Merck said in its statement on the settlement that the amount it would pay is “considerably less than Merck’s anticipated costs” in defending the cases.

From its inception, Gardasil was consistently a big seller for Merck and recorded dramatic growth in the early 2020s. It hit $8.9 billion in 2023 sales before the introduction of low-cost rivals in China led to a decline over the last two years.

Health and Human Services Secretary Robert F. Kennedy Jr., a veteran plaintiffs’ lawyer and vaccine skeptic, had helped prepare Robi’s claims for trial before he was appointed the nation’s top health official last year by President Donald Trump.

Kennedy, who had been in line to receive 10% referral fees on successful Gardasil lawsuits, has waived his right to collect that money, Bloomberg News has reported.

Merck avoided a showdown over Gardasil in North Carolina last year when a judge dismissed a group of more than 200 cases he concluded were preempted by the US Food and Drug Administration’s approval of the vaccine’s labeling. The judge also found “no scientist could reasonably conclude” the vaccine caused the alleged maladies “based on this paucity of evidence” offered by the plaintiffs’ expert witnesses.

Those cases are part of the deal, said the people familiar with the matter.

It’s a tricky time for vaccine manufacturers as they face unprecedented scrutiny under Kennedy, who has questioned vaccine safety for years.

In March, a judge temporarily blocked Kennedy’s effort to scale back the list of recommended childhood vaccinations, including the suggestion that young people get one HPV shot instead of as many as three. Kennedy is appealing the ruling, as is Children’s Health Defense, the non-profit he formerly led that has campaigned against immunizations.

The Los Angeles case is Robi v. Merck, BC628589, California Superior Court, County of Los Angeles.