Merck & Co. is facing its first jury trial over claims the company wrongfully marketed its lucrative Gardasil cancer vaccine as safe, the latest high-stakes litigation for the pharmaceutical giant.
Lawyers for a Los Angeles woman will argue Monday that the second-largest U.S. drugmaker by revenue misled consumers by overstating the benefits of the HPV vaccine and downplaying its risks. The shot is given to prevent human papillomavirus, which researchers have tied to cervical and other cancers.
Jurors will be asked to decide whether Merck withheld side-effect reports from U.S. drug regulators weighing the vaccine’s safety and launched misleading marketing campaigns to turn the drug into a blockbuster product. Merck racked up more than $8 billion in Gardasil sales in 2023.
Robert F. Kennedy Jr., President Donald Trump’s nominee for health secretary and a longtime plaintiffs’ lawyer, stands to benefit financially if the litigation succeeds.
“This case has monumental significance to public health and the ways we trust companies who produce vaccines,” Mark Lanier, a lawyer for plaintiff Jennifer Robi, said in an emailed statement. Lanier has won multiple billion-dollar verdicts against other drugmakers.
Merck denies it mishandled Gardasil’s marketing and says it properly outlined the vaccine’s potential side effects on its safety label. “An overwhelming body of scientific evidence continues to support the safety and efficacy of our HPV vaccines,” Robert Josephson, a spokesman for Rahway, New Jersey-based Merck, said in an emailed statement. “The plaintiff’s allegations have no merit, and we remain committed to vigorously defending against these claims.”
Kennedy has collected fees over the years for referring potential vaccine victims to a law firm that is spearheading the Gardasil litigation. As the founder of the nonprofit Children’s Health Defense, where he was a prominent skeptic of vaccines, Kennedy has criticized Gardasil as “dangerous and defective.”
Kennedy said in a federal ethics disclosure form that if confirmed as health secretary, he will still receive Gardasil referral fees. A press representative for Kennedy didn’t respond to phone calls seeking comment.
Vaccine Program
As head of HHS, Kennedy would oversee the National Vaccine Injury Compensation Program, set up in 1988 to compensate people injured by childhood vaccines. Since its inception, the program has paid out almost $5.3 billion to victims, according to the government.
As part of the system, injured claimants – such as Robi – have to first bring their cases in a special non-jury vaccine court, where judges decide whether injuries warrant compensation. If plaintiffs don’t recover or their case isn’t resolved in a certain amount of time, they can take their claims before a jury in the regular court system.
Government statistics show that about 73% of the 664 HPV vaccine claims over a 16-year period starting in 2006 resulted in no compensation or were dismissed. Since HPV cases haven’t had much success in vaccine court, attorneys have pulled petitions from that venue after the required period and are pursuing conventional civil suits, said Renee Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University in Washington, DC.
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Fast Heartbeat
In Robi’s case, a vaccine-court judge said in 2015 she couldn’t prove Gardasil caused a heart ailment that left her confined to a wheelchair. Robi’s lawyers filed suit in Los Angeles Superior Court the next year, alleging she developed Postural orthostatic Tachycardia Syndrome (POTS) from the shot. That ailment features a chronically fast heartbeat when a victim stands, which can lead to fainting and fatigue. Robi also contends she developed nerve damage from the Gardasil shot.
Her lawyers say Merck’s Gardasil marketing campaign failed to warn consumers and their doctors the vaccine was only effective against certain types of cancers and only had a five-year shelf life.
In its court filings, Merck points to the vaccine court’s finding that Robi failed to prove her injury was “actually caused” by a vaccination and argues that CDC officials haven’t “detected any safety concerns related to POTS following HPV vaccination.”
Merck faces a handful of Gardasil cases in state court in California while it deals with a consolidation of about 200 other cases in federal court in Charlotte, North Carolina, according to court dockets.
In previous high-profile litigation, Merck agreed in 2007 to pay almost $5 billion to settle personal injury suits claiming that its recalled pain drug Vioxx caused heart attacks and strokes. Last year, Merck won an appeals court ruling upholding the dismissal of almost 1,200 suits alleging its shingles vaccine, Zostavax, caused patients to develop the viral disease.
The case is Robi v. Merck & Co., BC628589, California Superior Court, County of Los Angeles.
