A U.S. appeals court is poised to hear arguments over the possible reinstatement of more than 500 lawsuits against Kenvue, the makers of Tylenol, as families allege that prenatal use of the painkiller is linked to autism and ADHD in children.
These cases were dismissed in 2024 by a lower court, which heavily criticized the plaintiffs’ expert witnesses for their methodology. But the plaintiffs now cite a September 2025 press conference, where Donald Trump and top health officials publicly suggested a link between Tylenol use during pregnancy and developmental disorders in children — a move they argue could help validate their claims.
Kenvue disputes the allegations, maintaining that robust scientific research shows no causal connection between acetaminophen (Tylenol’s active ingredient) and neurodevelopmental conditions. Meanwhile, legal analysts say a favorable ruling for plaintiffs could complicate Kenvue’s planned $40 billion acquisition by Kimberly-Clark, though both companies note the deal is not contingent on the litigation’s outcome.
In parallel, Texas Attorney General Ken Paxton has launched a separate lawsuit claiming Kenvue and Johnson & Johnson concealed risks associated with Tylenol during pregnancy — specifically, the alleged autism and ADHD risks.
The appeal marks a critical juncture: if the 2nd U.S. Circuit Court of Appeals decides to revive the suits, it would not only reshape the legal landscape for pharmaceutical liability but also fuel renewed scrutiny of how over-the-counter drugs are used and regulated.