Appeals Court Revives Over 500 Tylenol Autism Lawsuits Against Kenvue, Reopening Debate on Prenatal Acetaminophen Risks

A federal appeals court on July 13, 2026, revived more than 500 private lawsuits accusing Kenvue Inc.—the consumer health spin-off from Johnson & Johnson—of failing to warn about potential links between Tylenol (acetaminophen) use during pregnancy and autism or ADHD in children. The 2nd U.S. Circuit Court of Appeals in Manhattan ruled that a lower court had improperly excluded expert testimony from three doctors, finding their methodologies acceptable under scientific standards where experts may reasonably disagree. The panel remanded the cases for further proceedings.

The decision overturns a 2023 district court ruling that had dismissed the federal multidistrict litigation. Plaintiffs' attorneys argued the experts relied on legitimate evidence from epidemiological studies; Kenvue maintained the ruling addresses only procedural admissibility of witnesses, not causation, and reiterated that independent research has not established a causal link. Bloomberg Intelligence has estimated potential exposure from thousands of similar claims.

This legal development occurs amid persistent scientific controversy. While some observational studies have suggested associations between prenatal acetaminophen exposure and neurodevelopmental issues, major reviews and medical organizations continue to state that evidence does not demonstrate causation, often citing confounding factors. The lawsuits focus on alleged failure to disclose risks rather than proving definitive harm. Kenvue is also navigating a planned $40 billion acquisition by Kimberly-Clark, which reviewed litigation risks prior to the deal.

Broader context includes prior public statements, such as former President Trump's 2025 remarks advising pregnant women to avoid Tylenol and referencing FDA actions, though regulatory bodies have not issued conclusive warnings tying the drug to autism.