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Federal law preempts failure-to-warn claims

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Plaintiffs saw link to heart rate, ovarian problems

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Lawyer for plaintiffs had no immediate comment

(Adds details from decision, plaintiffs' accusations, comments,

Gardasil sales and patent information, case citation, byline)

By Jonathan Stempel

March 11 (Reuters) - A federal judge ruled in favor of

Merck ( MRK ) in litigation accusing it of concealing the risks

of Gardasil, a vaccine to prevent cervical and other cancers

caused by the human papillomavirus and one of the drugmaker's

best-selling products.

The decision made public on Tuesday by U.S. District Judge

Kenneth Bell in Charlotte, North Carolina applies to more than

200 lawsuits in the nationwide case.

So-called bellwether plaintiffs who received Gardasil

between 2012 and 2021 said the vaccine caused them to suffer

excessive increases in heart rates or premature ovarian failure,

and that Merck ( MRK ) should have added warnings to the labels.

But the judge said that by 2013, the latest the plaintiffs

said warnings were needed, Merck ( MRK ) and scientists had only a

"paucity" of evidence suggesting a causal connection between

Gardasil and the alleged symptoms.

He said that meant the Rahway, New Jersey-based drugmaker

had no authority to add the requested warnings under federal

law, which preempted the plaintiffs' state law-based

failure-to-warn claims.

"Federal law requires more than speculative inferences prior

to adding dire warnings to lifesaving vaccines that discourage

their use," Bell wrote in a 35-page decision. "That evidence is

lacking here."

A lawyer for some plaintiffs had no immediate comment,

having yet to review the decision.

Merck ( MRK ) said it was "extremely pleased," and that Gardasil

remains safe and effective "as reflected in its label."

Gardasil and Gardasil 9 are together Merck's ( MRK ) second

best-selling product, with global sales of $8.58 billion in

2024. U.S. patent protection expires in 2028.

The U.S. Centers for Disease Control and Prevention

recommend Gardasil for 11- and 12-year-olds to prevent cervical

and other cancers caused by the human papillomavirus.

Nearly 160 million doses were distributed in the United

States through the end of 2022, federal data show. The vaccine

was first approved in the U.S. in 2006.

U.S. Health and Human Services Secretary Robert F. Kennedy

Jr., a longtime vaccine skeptic, had been a lawyer of record for

the plaintiffs in some Gardasil cases against Merck ( MRK ), though he

is no longer involved.

The case is In re Gardasil Products Liability Litigation,

U.S. District Court, Western District of North Carolina, No.

22-md-03036.