Tylenol is displayed for sale at a CVS Pharmacy on Nov. 3, 2025 in Austin, Texas.
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A federal appeals court on Monday revived more than 500 private lawsuits against Tylenol maker Kenvue over the painkiller’s alleged link to autism.
The 2ndU.S. Circuit Court of AppealsinManhattansaid a district court judge improperly excluded expert testimony from three doctors offered by parents and guardians who tied Tylenol use during pregnancy to autism and attention deficit hyperactivity disorder (ADHD) in children.
There is no firm scientific evidence of such a link. The issue drew greater attention after PresidentDonald Trumpand topU.S. health officials in September suggested a link to autism.
In a 64-page decision for a three-judge panel, Circuit JudgeGuido Calabresisaid the testimony from the three doctors reflected methodologies used by other scientists, and “constitute acceptable interpretations of scientific evidence where scientists may, and in fact do, disagree.”
Kenvue agreed to be acquired by Kleenex tissue makerKimberly-Clarkfor more than$40 billionlast November.
Kenvue andKimberly-Clarkdid not immediately respond to requests for comment. Many retailers and pharmacy operators including CVS,Kroger,Target, Walgreens andWalmartwere also named as defendants.
Shares of Kenvue traded down20 centsat$19.28in morning trading.
Doctors and medical societies consider acetaminophen, the active ingredient in Tylenol, the preferred means to treat pain and fever during pregnancy, and Kenvue has long maintained that Tylenol is safe.
Kenvue’s former parent Johnson & Johnson made Tylenol for more than 60 years, and has also defended its safety.
Harvard dean’s testimony allowed
Calabresi stressed that the appeals court was not deciding whether using acetaminophen causes autism or ADHD, or whether elected officials should do more to protect public health.
He said the doctors whose testimony was wrongly excluded included Andrea Baccarelli, the dean ofHarvard University’sSchool of Public Health;Eric Hollander, a psychiatry professor at theAlbert Einstein College of Medicine, andBrandon Pearson, a toxicologist atColumbia University.
“We are pleased that the panel unanimously found that our key experts reliably applied their scientific methods and principles,”Ashley Keller, a lawyer for the parents, said in an email.
Kenvue, based inSummit, New Jersey, was spun off in 2023 byJohnson & Johnson.
The private lawsuits were dismissed inDecember 2024by U.S. District JudgeDenise CoteinManhattan, who criticized the methodology of the plaintiffs’ expert witnesses.
Experts often play a key role in product liability lawsuits such as the Tylenol cases.
Monday’s decision returns the lawsuits to Cote for further proceedings.
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