A federal appeals court revived more than 500 lawsuits accusing Tylenol maker Kenvue and major retailers of failing to warn consumers about an alleged link between acetaminophen use during pregnancy and autism or ADHD in children.

The lawsuits were dismissed in 2024 after a federal judge rejected testimony from three experts presented by parents and guardians. The 2nd U.S. Circuit Court of Appeals ruled Monday that the testimony should have been allowed because the doctors used scientific methods that other researchers also employ. The experts include Harvard public health dean Andrea Baccarelli and professors from Columbia University and Albert Einstein College of Medicine.

The court stressed that it was not deciding whether acetaminophen causes autism or ADHD, as there is currently no firm scientific evidence establishing such a connection. Kenvue has continued to defend Tylenol’s safety and plans to challenge the experts again. The lawsuits now return to federal district court for further proceedings, while Kenvue shares fell 1.8% following the decision.

The ruling puts a major scientific dispute back before the courts and could determine how much evidence plaintiffs need to pursue lawsuits involving widely used medications. The floodgates have opened in a sense, as more than 500 cases are now free to move forward because the appeals court concluded that disagreement among scientists was not enough to exclude expert testimony.

The consequences are likely to extend far beyond Tylenol, as product liability cases often depend on experts establishing whether a drug or consumer product caused an injury…

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Allowing these doctors to testify gives juries more power to weigh competing scientific conclusions rather than having judges end cases before trial. Kenvue itself is facing hundreds of revived claims as it prepares to be acquired by Kimberly-Clark for more than $40 billion. Some of the biggest-name retailers in the country, including Walmart, Target, CVS, Kroger, and Walgreens, are also defendants.

While the ruling does not prove Tylenol causes autism or ADHD, it does create new legal uncertainty for one of America’s most widely used medications and the companies that sell it.

Tylenol is one of the most commonly used treatments doctors prescribe to pregnant women to treat pain and fevers. Acetaminophen is still the preferred medication during pregnancy, but renewed litigation is almost certain to create hesitation for patients deciding whether to take it. The court did not find that Tylenol causes autism or ADHD, making that distinction especially important as the lawsuits return to court.

The most consequential result will be what exactly these cases reveal about a drug taken by millions of pregnant women for decades. More than 500 lawsuits will now move forward as experts argue over the evidence in court. Families may be forced to reconsider medical advice they once viewed as settled.

The outcome could also determine how much uncertainty is enough to hold a drugmaker responsible when scientists themselves disagree about whether a widely used medication can cause serious harm.

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