Merck & Co. said it would settle a series of lawsuits accusing the drugmaker’s blockbuster Gardavia cancer vaccine of causing an autoimmune disease that affects the hearts and reproductive systems of young women, but in numbers that are “not material” to the drug company.
Gardasil prevents human papillomavirus, or HPV, infection. Under the agreement, Merck will pay more than $50 million to resolve more than 200 cases, according to people familiar with the matter. The deal would also resolve a high-profile case that is set to be heard in state court in Los Angeles next month.
Merck, headquartered in Rahway, New Jersey, said in an emailed statement to Bloomberg News that it decided to “completely end the litigation” by settling all of the Gardavine vaccine lawsuits — except one. The company added that research and evidence “continue to support the safety and effectiveness of our HPV vaccine.” Researchers have linked HPV infection to cervical cancer.
In mass-injury lawsuits like the Gardasil case, a company can agree to pay a group of people who claim a product harmed them to settle the case without saying the product was harmful. Merck will not admit liability as part of the settlement, people familiar with the matter said. The person spoke on condition of anonymity because details of the discussions have not been made public.
An attorney for the Los Angeles case involving Jennifer Robi, a California woman who claims a heart attack caused by the Gardasil vaccine as a teenager left her confined to a wheelchair, declined to comment. Her case could be the first to go to a jury over Merck’s vaccine.
Since its introduction 20 years ago, the vaccine has been approved for use in about 150 countries, and Merck said its Gardasil and Gardasil 9 products have sold more than 900 million doses worldwide. Mainstream medicine has claimed it is safe and effective for decades. Merck strongly denies that the shot causes dangerous side effects.
The company said in its annual report in February that it had “entered into a proposed agreement” in October to end litigation that required additional steps to be completed. Merck officials said the deal can only go through if enough people to receive the vaccine sign on.
Merck said in its settlement statement that it would pay “significantly less than Merck’s anticipated defense costs.”
Since its launch, Gardasil has been Merck’s best-selling product and experienced significant growth in the early 2020s. The company has sales of $8.9 billion in 2023, but the introduction of low-cost competitors in China has led to sales declines in the past two years.
Health and Human Services Secretary Robert F. Kennedy Jr., a veteran plaintiffs’ lawyer and vaccine skeptic, helped prepare Robbie’s trial arguments before being appointed by President Donald Trump last year as the nation’s top health official.
Kennedy had been expected to receive a 10% referral fee in a successful Gardasil lawsuit, but he has given up his right to receive the money, Bloomberg reported. report.
Merck avoided a showdown over Gardasil in North Carolina last year when a judge dismissed more than 200 cases, concluding that the U.S. Food and Drug Administration’s approval of the vaccine’s label preempted it. The judge also found that “no scientist could reasonably conclude” that the vaccine caused the alleged illness “based on insufficient evidence” presented by the plaintiffs’ expert witnesses.
People familiar with the matter said the cases were part of the deal.
It’s a tricky time for vaccine makers as they face unprecedented scrutiny under Kennedy, who spent years questioning the vaccine’s safety.
In March, a judge temporarily blocked Kennedy’s efforts to scale back the list of recommended childhood vaccinations, including recommending that young people get one dose of the HPV vaccine instead of up to three doses. Kennedy, who is appealing the ruling, previously headed Children’s Health Defense, an anti-immunization nonprofit.
The Los Angeles case is Robi v. Merck, BC628589, Superior Court of Los Angeles County, California.
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