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Trump administration turned to an expert whom plaintiffs

had

relied on

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Plaintiffs lawyer cites "separation of powers concerns"

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Kenvue ( KVUE ) says claims lack legal merit, scientific support

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Appeals court slated to hear arguments next month

By Diana Novak Jones

Sept 24 (Reuters) -

Families appealing the dismissal of their lawsuits alleging

that Kenvue's ( KVUE ) Tylenol or generic versions of the pain-relief

medication caused their children's autism are asking an appeals

court to consider President Donald Trump's new advice that

pregnant women avoid the pain killer as it decides whether to

revive their lawsuits.

Ashley Keller, an attorney representing the plaintiffs, filed a

letter Wednesday alerting the New York-based 2nd U.S. Circuit

Court of Appeals to the Trump administration's stance on the

alleged link between Tylenol and autism. In a news conference at

the White House on Monday, Trump delivered medical advice to

pregnant women, repeatedly telling them not to use

acetaminophen, the active ingredient in Tylenol.

A judge last year dismissed hundreds of lawsuits alleging a

connection between Tylenol or generic versions of the drug and

autism or ADHD diagnoses, saying that the experts the plaintiffs

relied on had failed to support their conclusions with

scientific evidence.

In Wednesday's letter, Keller told the appeals court that a

ruling upholding the lower court's decision would pose "grave

separation of powers concerns," because the Trump administration

had turned to one the same experts in developing its position.

Keller noted that during Monday's press conference, U.S. Food

and Drug Commissioner Marty Makary, Health Secretary Robert F.

Kennedy Jr. and Trump cited the research on Tylenol and autism

done by Andrea Baccarelli, currently dean of the faculty at the

Harvard T.H. Chan School of Public Health, one of the

plaintiffs' experts.

In a statement, a Kenvue ( KVUE ) spokesperson noted that the FDA

said a causal relationship has not been established between

Tylenol and autism and said the company believes it will

continue to be successful in the litigation as the claims lack

legal merit and scientific support.

MORE THAN 500 LAWSUITS DISMISSED

U.S. District Judge Denise Cote in Manhattan last year

dismissed more than 500 lawsuits against Kenvue ( KVUE ) and

retailers that sold store-brand acetaminophen, which alleged

that the drugs caused autism spectrum disorder, or ADHD. Cote

had ruled the previous year that none of the expert witnesses

offered by the plaintiffs to testify at trial that acetaminophen

could cause the conditions had used a sound scientific

methodology. She said the experts' "unstructured approach"

allowed "cherry-picking" and a "results-driven analysis."

Product liability lawsuits, like the ones over

acetaminophen, rely on experts to establish that a product is

capable of causing the alleged harm.

The 2nd Circuit is slated to hear arguments on October 6 in

the plaintiffs' appeal of Cote's decision.

In Wednesday's letter, Keller argued that a decision

"holding that a jury may not hear the same expert evidence that

the executive branch credited will badly damage the public trust

required for the executive to take care that the public-health

laws are faithfully executed."

Legal experts have said it would be unusual if the appeals

court gave the administration's actions and Trump's comments

much weight in considering how to move forward with the cases.

"It's not as if there's been a new study that has been

announced that has a different conclusion," Elizabeth Chamblee

Burch, a professor at the University of Georgia's School of Law

whose research focuses on cases like the Tylenol litigation,

said on Tuesday before Keller filed the letter.

Researchers say there is no firm evidence of a link between

the use of Tylenol and autism. A 2024 study of nearly 2.5

million children in Sweden found no causal link between in utero

exposure to acetaminophen and neurodevelopmental disorders.

A 2025 review of 46 earlier studies that Baccarelli

participated in did suggest a link between prenatal

acetaminophen exposure and increased risks of these conditions,

but the researchers from the Icahn School of Medicine at Mount

Sinai, Harvard University and others said the study does not

prove the drug caused the outcomes.