- Posted October 29, 2025
Texas Sues Tylenol Over Alleged Autism Link
Texas Attorney General Ken Paxton has filed a lawsuit accusing Kenvue, the maker of Tylenol, and its former parent company, Johnson & Johnson, of misleading consumers about the safety of the popular pain reliever during pregnancy.
Filed Tuesday in Texas state court, the lawsuit claims the companies continued to sell acetaminophen products despite knowing the drug could be linked to autism and ADHD — an allegation that federal health officials have said is still unproven.
Paxton, a Republican candidate for U.S. Senate, called the case an effort to hold “Big Pharma accountable,” saying in a statement, “by holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again."
Kenvue called the lawsuit “baseless,” saying its product is safe when used as directed.
Acetaminophen “is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy," the company stated.
Johnson & Johnson, which spun off Kenvue in 2023, said the new company now holds all rights and liabilities for Tylenol.
The U.S. Food and Drug Administration (FDA) recently said it is beginning a process to change Tylenol’s labeling. The change would note that prenatal acetaminophen use “may be associated” with an increased risk of certain developmental disorders.
The FDA added, however, that “a causal relationship has not been established.”
While acknowledging that some studies suggest a possible connection, the FDA noted that others have found no link, and that acetaminophen remains the only nonprescription fever and pain reliever approved for use during pregnancy, The Washington Post reported.
Paxton’s lawsuit claims that Johnson & Johnson’s own internal research showed a potential connection in 2014 between acetaminophen and autism, but the company did not make that information public.
Many of the same arguments appeared in earlier federal lawsuits filed by individuals claiming Tylenol caused autism in their children.
Those cases, which were consolidated in 2022, were dismissed after a judge ruled that the plaintiffs’ expert witnesses were unreliable. The decision is under appeal, The Post said.
Meanwhile, some advocacy groups, like the Informed Consent Action Network, have urged the FDA to add autism and ADHD warnings to acetaminophen products.
Kenvue has publicly opposed those label changes, saying the proposed warnings are “unsupported by the scientific evidence.”
More information
The American Academy of Pediatrics has more on acetaminophen safety.
SOURCE: The Washington Post, Oct. 28, 2025
