A federal appeals court is reviewing whether to revive more than 500 lawsuits filed by parents claiming their children developed autism or ADHD due to prenatal exposure to Tylenol, Baltimore Chronicle.
The lawsuits were dismissed in December 2023 by U.S. District Judge Denise Cote, who found that the plaintiffs’ expert witnesses had not provided credible evidence linking Tylenol, or its active ingredient acetaminophen, to autism or ADHD. Judge Cote criticized the experts’ methodology, stating that “the unstructured approach adopted by the plaintiffs’ experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data.”
During a hearing this week, two of the three judges on the U.S. Court of Appeals for the Second Circuit in Manhattan suggested that some of the expert testimony might have been admissible and that the cases may have been dismissed prematurely. Circuit Judge Gerard Lynch said, “I’m having trouble understanding why the district court was correct to say that this just is nonsense. This is something that no one should hear. It just goes out the window, when it seems to me that you have a reputable scientist explaining why each of these judgment calls was made.”
Circuit Judge Guido Calabresi also noted that the cases could have proceeded to a jury. “All that matters is if people bring in evidence, so that then juries or courts may say, ‘This goes one way or the other,'” he said.
The controversy arose after the Trump administration in September suggested that prenatal use of Tylenol might be associated with an increased risk of autism, advising pregnant women to limit its use. This recommendation contradicts most current medical guidance.
While some studies have suggested a potential association, major medical organizations, including the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, continue to recommend acetaminophen as the safest pain reliever during pregnancy under medical supervision. An August 2025 meta-analysis from researchers at Mt. Sinai, Harvard T.H. Chan School of Public Health, UCLA Fielding School of Public Health, and UMass Lowell indicated a possible link, whereas a 2024 NIH-funded study in JAMA and a recent BMJ review found no clear evidence of a causal connection.
Separately, Texas Attorney General Ken Paxton filed a lawsuit last month against Johnson & Johnson and Kenvue, alleging that they deceptively marketed Tylenol to pregnant women despite potential links to autism and other disorders. Johnson & Johnson sold the medication for decades, and Kenvue, its consumer health spinoff, has sold the drug since 2023. Kimberly Clark recently announced plans to acquire Kenvue.
Kenvue has consistently denied any link between acetaminophen and autism. In a statement to ABC News in September, the company said, “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers. Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
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