US appeals court to reconsider dismissed autism-Tylenol-link lawsuits
3 Min Read
Legal and public debate surrounding Tylenol and autism was reignited following statements made by Trump administration officials.
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Tylenol drugs are on display at a drugstore chain in Buffalo Grove, Ill, Tuesday, September 23, 2025. (AP Photo/Nam Y Huh)
A US federal appeals court is set to hear arguments from families seeking to revive over 500 lawsuits against Kenvue, the company behind Tylenol. The plaintiffs assert that prenatal exposure to acetaminophen, the active ingredient in Tylenol, may be linked to autism spectrum disorder in children.
Their case, previously dismissed in 2024 due to what a lower court deemed flawed expert testimony, has regained momentum following statements made by US President Donald Trump and his top health officials.
In September 2025, Trump held a press conference alongside Health and Human Services Secretary Robert F Kennedy Jr, where they claimed a possible link between Tylenol use during pregnancy and increased autism risk.
Trump warned that acetaminophen "can be associated with a very increased risk of autism," advising pregnant women to avoid it. These remarks were based on a Harvard-led meta-analysis of 46 studies that suggested an "association," though not causation, between prenatal Tylenol exposure and neurodevelopmental disorders.
Despite widespread criticism from health experts, Trump's statements have influenced legal proceedings. Plaintiffs' attorneys submitted their comments to the 2nd US Circuit Court of Appeals, arguing that the prior dismissal did not sufficiently weigh the credibility of their expert evidence in light of new federal attention.
Scientific community rejects autism link
Major medical institutions, including the American College of Obstetricians and Gynecologists and the World Health Organization, maintain that acetaminophen remains a safe option for pain relief during pregnancy. A 2024 Swedish study involving nearly 2.5 million children found no causal connection between prenatal acetaminophen use and autism or ADHD when accounting for genetic and environmental factors. A similar Japanese study corroborated those findings.
Even the FDA issued a tempered statement, acknowledging associations in some studies but asserting that "a causal relationship has not been established."
Health professionals warned that discouraging acetaminophen use could endanger pregnant women, as untreated fever and pain may lead to serious complications, including preterm birth and congenital anomalies.
Implications for Kenvue
Kenvue has defended its product's safety and supports the lower court’s original dismissal of the lawsuits. The company is also facing a separate case brought by Texas Attorney General Ken Paxton, who alleges that Kenvue misled the public about Tylenol’s safety. A Texas judge recently declined to block a $398 million dividend payout by Kenvue, as well as a request to temporarily alter its marketing.
The outcome of the appeals process may also affect Kenvue's impending $40 billion acquisition by Kimberly-Clark. Although merger documents filed with regulators specify that litigation tied to autism or ADHD claims will not disrupt the deal, legal experts suggest the revival of lawsuits could carry reputational and financial consequences.
While Trump's administration later softened its stance, noting the evidence was not definitive, the legal and public debate surrounding Tylenol and autism has been reignited.
