By Dan Levine and Mike Spector

(Reuters) – Robert F. Kennedy Jr. played a major role in organizing the mass litigation against the drugmaker Merck (NS:) about the Gardasil vaccine, a strategy that faces its first trial 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, is awaiting confirmation as US Secretary of Health and Human Services (HHS). The task would give him direct authority over a special vaccine court to pay damages.

The details of the Gardasil litigation show how Kennedy acted without 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 attorney for plaintiffs, 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, such cases must first be filed in a special vaccine court run by HHS that aims to respond quickly to claims, but restricts compensation and limits the liability of vaccine makers.

That process has discouraged top lawyers who represent hundreds or thousands of plaintiffs in liability cases that have the potential to reap millions, and sometimes billions, of dollars in payouts. company.

Krakow found reasons to directly sue Merck over its human papillomavirus shot Gardasil after handling several vaccine injury claims in court. He believes there is also evidence that Merck fraudulently advertised Gardasil as safe, exaggerating its benefits while hiding knowledge of its dangerous side effects.

Kennedy promoted that strategy among a network of influential lawyers who acquired major corporations for other products, Krakow said.

“He is a galvanizing force,” Krakow told Reuters. Kennedy’s presence at Gardasil strategy meetings helped spark the interest of lawyers Krakow couldn’t have recruited on his own, he said.

Kennedy did not respond to requests for comment on the Gardasil litigation and did not indicate whether he would change the vaccine fee as health secretary. It’s unclear whether Kennedy will earn any compensation in the Gardasil cases, as usual.

Merck did not comment on Kennedy’s role in the litigation, which it said was without merit.

Gardasil is recommended as a routine vaccination for 11- and 12-year-old children by the US Centers for Disease Control and Prevention to prevent cervical and other cancers caused by the virus. Nearly 160 million doses have been distributed in the US 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 on Reuters. “We remain committed to vigorously defending against these claims in future trials.”

‘BOBBY TEACHED US’

Michael Baum was one of the high-profile lawyers Kennedy persuaded to pursue the Gardasil cases. The two became friends as neighbors in the affluent community of Malibu outside Los Angeles, and are now working together on a lawsuit Monsanto (NYSE:)’s weed killer Roundup, Baum said. The case ultimately won a $289 million verdict that was later reduced.

Baum was initially unaware that vaccine claims could be pursued outside of the government-run compensation system through traditional lawsuits.

“It’s an expensive, scary thing for lawyers and experts to go up against a big vaccine manufacturer,” Baum told Reuters. “Bobby taught us.”

The first trial is scheduled to begin on January 21 in Los Angeles state court, one day after Trump’s inauguration. Jennifer Robi, 30, was vaccinated with Gardasil as a teenager and claims the shot led to a mobility impairment that confined her to a wheelchair.

The vaccine court rejected Robi’s compensation claim in 2015 because the alleged harm was not shown to be linked to Gardasil.

Robi sued Merck in 2016 and included fraud among the claims. Kennedy, Baum and several other plaintiffs’ attorneys began representing him in 2018. They have since included similar fraud claims in other Gardasil cases, court filings show.

Approximately 200 Gardasil cases have been consolidated into a multi-district proceeding before a judge in North Carolina since 2022. Kennedy is attorney of record in some of the cases.

Despite their long-standing alliance, Baum and colleagues asked a Los Angeles judge to bar the mention of Kennedy’s name in front of jurors.

Kennedy is “not currently” an active litigation attorney, they wrote in court in November, and his association with Trump “risks inciting potentially strong political opinions or biases.”

The judge ruled that Merck’s defense team could ask questions about Kennedy’s relationship with one of Robi’s expert witnesses, a former employee of the nonprofit organization he founded, Children’s Health Defense. The judge said the questioner could only refer to him in that context, and as “Mr. Kennedy,” not his full name.

As Secretary of HHS, Kennedy could remove individual vaccines from the vaccine court. Plaintiffs’ attorneys can sue manufacturers directly and pursue a broader set of claims from the start, said Dorit Reiss, a professor at UC Law San Francisco.

Such high risk could lead vaccine makers to raise prices or pull a product from the market, said John Grabenstein, a consultant and former vaccine distribution executive at Merck not involved in Gardasil litigation.

Krakow opposes removing any vaccines from the special court, which he says would help consumers with minor injuries who don’t have the capacity to sue drug makers. He said he emailed Kennedy a week after the November presidential election to discuss more moderate reforms to the system.

Kennedy’s response: “We’ll talk about it after January 20.”