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FDA Tylenol label change could bolster autism lawsuits, says law firm

Jeff Barker, The Baltimore Sun on

Published in Health & Fitness

BALTIMORE — A change in the safety labels on Tylenol and other acetaminophen products could be a game changer for people claiming they weren’t properly warned about possible links between the pain reliever and autism, according to the law firm of the late Peter Angelos.

The Baltimore firm of the longtime Orioles owner, who was known for representing asbestos and tobacco victims, represents dozens of clients considering such legal claims, said Jay Miller, one of the firm’s principal owners.

“We’ve had an increase in inquiries. The phone is ringing,” Miller said, following hotly contested claims by President Donald Trump on Tuesday of ties between Tylenol, vaccines and autism, a complex brain disorder.

Miller said the firm was assessing the legal and regulatory landscape before filing suits, most of which were in the works before a White House news conference in which Trump repeatedly instructed pregnant women: “Don’t take Tylenol.”

The Food and Drug Administration said this week it was initiating a label change “to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.”

“If they do change the label on the packaging, well, that’s what we’ve been arguing all along. So that’s a win and I think it is going to make it difficult for the company not to pay these victims now,” Miller said.

Trump’s claims were disputed by Kenvue, Tylenol’s New Jersey-based manufacturer. The company told The Baltimore Sun in a statement: “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents.”

Tylenol is a brand of acetaminophen, a popular pain reliever.

The White House news conference amplified efforts by Trump and Health and Human Services Secretary Robert F. Kennedy Jr., to address the root causes of autism. One in 33 children in the United States has autism, according to Autism Speaks, an advocacy group. There are many variations of autism, which often affect social skills and speech.

While some studies have shown that prenatal use of acetaminophen, the active ingredient in Tylenol, may increase the risk of neurodevelopmental disorders such as autism spectrum disorder, researchers have also said more studies are needed before determining causality.

Joshua Sharfstein, a Johns Hopkins Bloomberg School of Public Health professor, expressed concern that people are getting confusing guidance from the federal government.

 

“One of the challenges of what happened [Tuesday] is that there is already inconsistent information,” Sharfstein, a former principal deputy commissioner of the U.S. Food and Drug Administration, told The Sun.

While Trump urged pregnant women to avoid Tylenol, Sharfstein said the FDA said “talk to your doctor, basically. Those are very different messages.”

Sharfstein suggested the government form an advisory committee to try to resolve outstanding questions.

A New York federal judge, in 2023 and 2024 rulings, dismissed cases filed by people claiming inadequate warnings about acetaminophen. The plaintiffs have appealed to the 2nd U.S. Circuit Court of Appeals.

Those legal developments caused a lot of lawyers to take “a wait and see approach” to filing new suits on the subject, Miller said.

It’s uncertain how Trump’s statements on Tuesday could affect the outcome of such suits.

Kathleen Hoke, a professor at the University of Maryland Francis King Carey School of Law, said in an interview that there was a lack of “real science” presented on Tuesday that could influence judicial decisions.

“I don’t think it even has a persuasive effect. In legal terms, it’s a nothing burger,” she said.

Tylenol’s manufacturer, Hoke added, would be unable to sue the federal government claiming misinformation. Legal actions against the government are limited and don’t include defamation cases.

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©2025 The Baltimore Sun. Visit at baltimoresun.com. Distributed by Tribune Content Agency, LLC.

 

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