Written by Dan Levin and Mike Spector
(Reuters) – Robert F. Kennedy Jr. was instrumental in organizing a class-action lawsuit against the drug company Merck (NS:) on the Gardasil vaccine, a strategy that faces its first test in a Los Angeles court next week, according to lawyers close to the case and court filings.
Kennedy, who ended his presidential campaign last year in support of Donald Trump, is awaiting confirmation as US Secretary of Health and Human Services. This role would give him direct authority over the special vaccine tribunal that compensates for injuries.
The details of the Gardasil lawsuit show how Kennedy took action beyond sowing doubt about the safety and effectiveness of vaccines in the court of public opinion and helped build a case against the drug industry before judges and juries.
Kennedy, a longtime plaintiffs' attorney, became involved in the Gardasil lawsuit in 2018 in collaboration with Robert Krakoff, an attorney who specializes in vaccine injury cases, Krakoff said.
Under US law, such cases must first be brought to a special vaccine court run by the Department of Health and Human Services that aims to process claims quickly, but caps damages and limits liability for vaccine makers.
This process has discouraged top lawyers who represent hundreds or thousands of plaintiffs in liability lawsuits that could generate millions, sometimes billions, of dollars in company payouts.
Krakow saw grounds to sue Merck directly for its HPV infection shot Gardasil after dealing with some infection claims in vaccine court. He believed there was also evidence that Merck had fraudulently declared Gardasil safe, exaggerating its benefits while concealing knowledge of its serious side effects.
Kennedy championed this strategy among a network of influential lawyers who acquired major companies at the expense of other products, Krakoff said.
“He was a driving force,” Krakow told Reuters. He said Kennedy's presence at Gardasil strategy meetings helped interest lawyers that Krakow had not been able to recruit on his own.
Kennedy did not respond to requests for comment on the Gardasil lawsuit and did not clarify whether he would change vaccine reimbursement as health secretary. It is not clear whether Kennedy will earn any fees from Gardasil cases, as is usual.
Merck did not comment on Kennedy's role in the lawsuit, which it said was baseless.
Gardasil is recommended as a routine immunization for children ages 11 to 12 years old by the U.S. Centers for Disease Control and Prevention to prevent cervical cancer and other cancers caused by the virus. Nearly 160 million doses have been distributed in the United States through the end of 2022, federal data show.
“A tremendous body of scientific evidence, including more than 20 years of research and development, continues to support the safety and efficacy standards for our HPV vaccines,” Merck said in a statement to Reuters. “We remain committed to vigorously defending against these allegations at the upcoming trial.”
“Bobby taught us.”
Michael Baum is one of the prominent lawyers whom Kennedy convinced to pursue the Gardasil cases. The two had become friends as neighbors in the affluent Malibu community outside Los Angeles, and were already cooperating on a lawsuit that ended Monsanto (NYSE:) Roundup Weed Killer, Baum said. The case eventually won a $289 million judgment that was later reduced.
Baum was initially unaware that vaccine-related claims could be pursued outside the government-run compensation system through traditional lawsuits.
“It is expensive and cumbersome for lawyers and experts to go against a large vaccine manufacturer,” Baum told Reuters. “Bobby taught us.”
The first trial is scheduled to begin on January 21 in a state court in Los Angeles, the day after Trump's inauguration. Jennifer Ruby, 30, received the Gardasil vaccine as a teenager, and claims the vaccination resulted in reduced mobility that left her confined to a wheelchair.
The Vaccine Tribunal rejected Robbie's claim for damages in 2015 because it had not been proven that the alleged injury was linked to Gardasil.
Ruby sued Merck in 2016 and listed fraud among the claims. Kennedy, Baum and several other plaintiffs' attorneys began representing her in 2018. Since then, they have incorporated a similar fraud claim into other Gardasil lawsuits, court filings show.
Nearly 200 lawsuits have been consolidated with Gardasil in a multidistrict suit before a North Carolina judge since 2022. Kennedy is an attorney of record in some of those cases.
Despite their longstanding alliance, Baum and his colleagues asked a Los Angeles judge to prevent Kennedy's name from being mentioned to jurors.
Kennedy “is not currently” an active attorney in the lawsuit, they wrote to the court in November, and his association with Trump “risks giving rise to potentially strong political opinions or biases.”
The judge ruled that Merck's defense team could inquire about Kennedy's relationship with one of Ruby's expert witnesses, a former employee of the nonprofit he founded, Children's Health Defense. The judge said that questioning could only refer to him in this context, and as “Mr. Kennedy”, not his full name.
As secretary of the Department of Health and Human Services, Kennedy can remove individual vaccines from the Vaccine Court. Plaintiffs' attorneys can then sue manufacturers directly and pursue a broader range of claims from the beginning, said Dorit Rees, a professor at the University of California, San Francisco.
Such an increased risk could prompt vaccine makers to raise prices or pull a product from the market, said John Grabenstein, a consultant and former vaccine distribution executive at Merck who was not involved in the Gardasil lawsuit.
Krakow opposes removing any vaccines from the special court, which he says helps consumers with minor injuries who do not have the ability to sue drug makers. He said he emailed Kennedy a week after the November presidential election to discuss more modest reforms to the system.
Kennedy responded: “Let's talk about that after January 20th.”
