By Dan Levine and Mike Spector
(Reuters) – Robert F. Kennedy Jr. played a key role in organizing massive litigation against the drug maker. merck (NS:) about its Gardasil vaccine, a strategy that faces its first test in a Los Angeles court next week, according to two lawyers close to the case and court documents.
Kennedy, who ended his own presidential campaign last year to endorse Donald Trump, is awaiting confirmation as U.S. Secretary of Health and Human Services (HHS). The role would give him direct authority over a special vaccine court that compensates for injuries.
The details of the Gardasil litigation show how Kennedy went beyond sowing doubt about the safety and effectiveness 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' attorney, became involved in the Gardasil litigation in 2018 in collaboration with Robert Krakow, an attorney specializing in vaccine injury cases, Krakow said.
Under US law, these cases must first be brought before the special vaccine court run by HHS, which aims to address claims quickly but limits compensation and liability for vaccine manufacturers.
That process had discouraged top lawyers from representing hundreds or thousands of plaintiffs in liability lawsuits with the potential to obtain millions, and sometimes billions, of dollars in payments to companies.
Krakow saw grounds to sue Merck directly over its human papillomavirus vaccine, Gardasil, after handling some injury claims in vaccine court. He believed there was also evidence that Merck had fraudulently advertised Gardasil as safe, exaggerating its benefits and concealing knowledge of dangerous side effects.
Kennedy championed that strategy among a network of influential lawyers who had taken on big corporations over other products, Krakow said.
“It was a galvanizing force,” Krakow told Reuters. Kennedy's presence at Gardasil's strategic meetings helped spark interest from lawyers Krakow would not have been able to hire on its 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 unclear whether Kennedy would earn any fees for the Gardasil cases, as would be typical.
Merck did not comment on Kennedy's role in the litigation, which it said had no merit.
The U.S. Centers for Disease Control and Prevention recommends Gardasil as a routine vaccine for children ages 11 and 12 to prevent cervical cancer and other cancers caused by the virus. Nearly 160 million doses have been distributed in the U.S. through the end of 2022, federal data shows.
“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 allegations at the upcoming trial.”
'BOBBY TAUGHT US'
Michael Baum is one of the high-profile lawyers persuaded by Kennedy to pursue the 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 (NYSE:) Roundup, the (NYSE:) herbicide, Baum said. The case ultimately garnered a $289 million verdict that was later reduced.
Baum was initially unaware that vaccine claims could be filed outside of the government-run compensation system through traditional lawsuits.
“It is expensive and discouraging for lawyers and experts to take on a large vaccine manufacturer,” Baum told Reuters. “Bobby taught us.”
The first trial will begin Jan. 21 in state court in Los Angeles, a day after Trump's inauguration. Jennifer Robi, 30, was vaccinated with Gardasil as a teenager and says the shot caused mobility problems that confined her to a wheelchair.
The vaccine court denied Robi's compensation claim in 2015 because the alleged injury had not been proven to be related to Gardasil.
Robi sued Merck in 2016 and included 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 documents show.
About 200 Gardasil lawsuits have been consolidated into a multidistrict 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 his colleagues asked the Los Angeles judge to prohibit the mention of Kennedy's name in front of the jury.
Kennedy is “not currently” 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 ask about Kennedy's relationship with one of Robi's expert witnesses, a former employee of the nonprofit he founded, Children's Health Defense. The judge said the cross-examination 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' attorneys could then sue the manufacturers directly and file a broader set of claims from the start, said Dorit Reiss, a law professor at UC San Francisco.
Such a heightened risk could lead vaccine makers to raise prices or withdraw a product from the market, said John Grabenstein, a consultant and former Merck vaccine distribution executive who is not involved in the litigation against Gardasil.
Krakow opposes removing any vaccines from the special court, which it 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's response: “Let's talk about it after January 20.”
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