The 2nd U.S. Circuit Court of Appeals ruled that a lower court improperly excluded expert testimony offered by families pursuing claims against Tylenol maker Kenvue.
By yourNEWS Media Newsroom
NEW YORK — A federal appeals court on Monday revived more than 500 private lawsuits alleging that Tylenol use during pregnancy contributed to autism or attention deficit hyperactivity disorder in children.
The 2nd U.S. Circuit Court of Appeals in Manhattan ruled that the district court had improperly excluded testimony from expert witnesses presented by parents and guardians bringing claims against Kenvue, the manufacturer of Tylenol.
The decision allows the consolidated litigation to move forward after the cases were dismissed in December 2024.
The lawsuits allege that prenatal exposure to acetaminophen, the active ingredient in Tylenol, is associated with autism and attention deficit hyperactivity disorder, commonly known as ADHD.
There is no firm scientific evidence establishing such a causal connection.
The issue received greater public attention after President Donald Trump and senior U.S. health officials suggested in September that Tylenol use during pregnancy could be linked to autism.
Kenvue did not immediately respond to a request for comment following Monday’s ruling.
The company’s shares fell 10 cents to $19.38 in morning trading.
Doctors and major medical organizations have generally regarded acetaminophen as the preferred medication for treating pain and fever during pregnancy.
Kenvue has repeatedly defended the safety of Tylenol.
The Summit, New Jersey-based company was separated from Johnson & Johnson in 2023. Johnson & Johnson manufactured Tylenol for more than six decades and also maintained that the drug was safe.
The revived lawsuits were dismissed by U.S. District Judge Denise Cote in Manhattan in December 2024.
Cote rejected the plaintiffs’ expert testimony after criticizing the methodologies used to support their conclusions.
The proposed experts included Andrea Baccarelli, dean of the Harvard School of Public Health.
The appeals court concluded that the testimony should not have been excluded in the manner applied by the district court, reopening the path for the families’ claims.
Expert witnesses often play a central role in product liability cases because plaintiffs must generally present scientific evidence supporting claims that a product caused or contributed to an injury.
Monday’s ruling does not establish that Tylenol causes autism or ADHD. It instead addresses whether the plaintiffs’ proposed experts should be permitted to offer testimony as the cases proceed.
The decision came after Kenvue agreed in November to be acquired by Kimberly-Clark, the manufacturer of Kleenex tissues, in a transaction valued at more than $40 billion.
The litigation now returns to the lower court for further proceedings.
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