Robert F. Kennedy Jr. played an instrumental role in organizing mass litigation against drugmaker Merck over its Gardasil vaccine, a strategy that faces its first test in a Los Angeles court next week, according to two attorneys close to the case and court filings.
Kennedy, who ended his own presidential campaign last year to endorse Donald Trump, awaits confirmation as U.S. Health and Human Services (HHS) Secretary. The role would give him direct authority over a special vaccine court that compensates injuries.
Details of the Gardasil litigation show how Kennedy took action beyond sowing doubt about the safety and efficacy of vaccines in the court of public opinion and helped build a case against the pharmaceutical industry before judges and juries.
Kennedy, a longtime plaintiffs' lawyer, became involved in the Gardasil litigation in 2018 in collaboration with Robert Krakow, an attorney specializing in vaccine injury cases, Krakow said.
Under U.S. law, such cases must first be filed with the special vaccine court run by HHS that aims to address claims quickly, but caps compensation and limits vaccine makers' liability.
That process had discouraged top lawyers who represent hundreds or thousands of plaintiffs in liability lawsuits with the potential to reap millions, and sometimes billions, of dollars in company payouts.
Krakow saw grounds to sue Merck directly over its human papillomavirus shot Gardasil after handling some injury claims in vaccine court. He believed there was also evidence that Merck had fraudulently advertised Gardasil as safe, overstating its benefits while concealing knowledge of dangerous side effects.
Kennedy championed that strategy among a network of influential lawyers who had taken on major corporations over other products, Krakow said.
"He was a galvanizing force," Krakow told Reuters. Kennedy's presence in Gardasil strategy meetings helped pique the interest of lawyers whom Krakow would have been unable to recruit on his own, he said.
Kennedy did not respond to requests for comment on the Gardasil litigation and has not indicated whether he would change vaccine compensation as health secretary. It is not clear whether Kennedy would earn any fees off the Gardasil cases, as would be customary.
Merck did not comment on Kennedy's role in the litigation, which it said had no merit.
Gardasil is recommended as a routine immunization for 11 and 12-year-olds by the U.S. Centers for Disease Control and Prevention to prevent cervical and other cancers caused by the virus. Nearly 160 million doses were distributed in the U.S. through the end of 2022, federal data show.
"An overwhelming body of scientific evidence, including more than 20 years of research and development, continues to support the safety and efficacy profiles of our HPV vaccines," Merck said in a statement to Reuters. "We remain committed to vigorously defending against these claims in the upcoming trial."
'BOBBY TAUGHT US'
Michael Baum is one of the high-profile lawyers persuaded by Kennedy to pursue Gardasil cases. The two became friends as neighbors in the wealthy Malibu community outside Los Angeles, and were already collaborating on a lawsuit over Monsanto's weed killer Roundup, Baum said. The case eventually won a $289 million verdict that was later reduced.
Baum was initially unaware that vaccine claims could be pursued outside the government-run compensation system through traditional lawsuits.
"It's an expensive, daunting thing for lawyers and experts to go up against a large vaccine manufacturer," Baum told Reuters. "Bobby taught us."
The first trial is set to begin on Jan. 21 in a state court in Los Angeles, a day after Trump's inauguration. Jennifer Robi, 30, was vaccinated with Gardasil as a teenager and claims the shot led to impaired mobility that confined her to a wheelchair.
The vaccine court denied Robi's compensation claim in 2015 because the alleged injury had not been shown to be linked to Gardasil.
Robi sued Merck in 2016 and included fraud among the claims. Kennedy, Baum and several other plaintiffs' lawyers began representing her in 2018. They have since incorporated a similar fraud claim into other Gardasil lawsuits, court filings show.
Roughly 200 Gardasil lawsuits have been consolidated into a multi-district proceeding before a North Carolina judge since 2022. Kennedy is an attorney of record in some of those cases.
Despite their long-standing alliance, Baum and colleagues asked the Los Angeles judge to forbid mentioning Kennedy's name in front of jurors.
Kennedy is "not presently" an active attorney in the lawsuit, they wrote to the court in November, and his association with Trump "risks inciting potentially strong political opinions or biases."
The judge ruled that Merck's defense team can inquire about Kennedy's relationship to one of Robi's expert witnesses, a former employee of the nonprofit organization he founded, Children's Health Defense. The judge said the questioning can only refer to him in that context, and as "Mr. Kennedy," not his full name.
As HHS Secretary, Kennedy could remove individual vaccines from the vaccine court. Plaintiffs' lawyers could then sue manufacturers directly and pursue a wider set of claims from the outset, said Dorit Reiss, a professor at UC Law San Francisco.
Such heightened risk could lead vaccine makers to raise prices or pull a product off the market, said John Grabenstein, a consultant and former Merck vaccine distribution executive who is not involved in the Gardasil litigation.
Krakow opposes removing any vaccines from the special court, which he says helps consumers with minor injuries who don't have the capacity to sue drugmakers. He said he emailed Kennedy a week after the November presidential election to discuss more modest reforms of the system.
Kennedy's response: "Let's talk about it after Jan. 20."
