Appeals court revives 500 lawsuits over Tylenol use in pregnancy
A federal appeals court revived more than 500 Tylenol suits after faulting a New York judge for excluding expert evidence. The ruling reopens litigation without proving causation.
A federal appeals court on Monday revived more than 500 private lawsuits accusing Tylenol makers and retailers of failing to warn pregnant women about claims that prenatal acetaminophen use caused autism spectrum disorder and attention-deficit/hyperactivity disorder in children.
The U.S. Court of Appeals for the Second Circuit in Manhattan overruled U.S. District Judge Denise L. Cote of the Southern District of New York, who had excluded the plaintiffs’ general-causation experts and then granted summary judgment for defendants in Rutledge v. Walgreen Co. and Phippen v. Walgreen Co. The appeals court said that ruling had gone too far in rejecting the testimony offered by parents and guardians pursuing the claims.
The cases name defendants including Walgreens, Costco, CVS, Safeway, Walmart, Rite Aid, Family Dollar, Target, Sam’s West, Dollar Tree, 7-Eleven, Kroger, Big Lots, Giant Food, Albertsons, Harris Teeter, Dolgencorp, and Johnson & Johnson Consumer Inc. The litigation centers on acetaminophen, the active ingredient in Tylenol and generic versions sold by major retailers, and on whether warnings should have addressed alleged autism and ADHD risks during pregnancy.
The appeal was argued on Nov. 17, 2025, and the court issued its decision on July 13, 2026.
Public attention sharpened after President Donald Trump and top U.S. health officials suggested a Tylenol-autism link in September 2025. On Sept. 22, 2025, the Food and Drug Administration said it had begun the process of changing acetaminophen labeling after concluding that recent evidence suggested an association between acetaminophen use during pregnancy and autism and ADHD. The agency cited large cohort studies including the Nurses’ Health Study II and the Boston Birth Cohort, and said some evidence suggested the risk may be strongest when the drug is taken chronically throughout pregnancy. Even so, the FDA said it remained reasonable for pregnant women to use acetaminophen in certain scenarios.
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