Texas Sues J&J, Kenvue Over Alleged Tylenol Autism Risks (1)

The state of Texas sued Johnson & Johnson and Kenvue Tuesday, alleging that the companies hid the risks of autism and other disorders for children if mothers take Tylenol during pregnancy.

The lawsuit, filed in state court in Texas, claims that the two drugmakers deceptively marketed Tylenol despite knowing the risks of the drug. It comes weeks after President Donald Trump claimed the drug caused autism in children, a link that has not been proven.

“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks,” Texas Attorney General Ken Paxton said in a statement. “These corporations lied for decades, knowingly endangering millions to line their pockets.”

The suit adds to pressure on the drugmakers over the issue, which has been a focus of Robert F. Kennedy Jr., the Secretary of Health and Human Services. Trump on Friday intensified his campaign against Tylenol to include young kids, posting on his Truth Social that parents shouldn’t give children the drug “for virtually any reason” without providing scientific evidence for the claim.

Read More: Trump Ratchets Up Pressure on Tylenol With Warning for Kids

Kenvue, a Johnson & Johnson spinoff, has made Tylenol since 2023. The company called the allegations behind Paxton’s lawsuit baseless and asserted that its medication is safe for pregnant women to take, noting that both pain and fevers in pregnant women can be dangerous for their children.

“We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children,” it said in a statement.

Texas alleged both companies knowingly withheld evidence that acetaminophen, the active ingredient in Tylenol and a common pain and fever treatment, was linked to autism and attention deficit hyperactivity disorder in children when taken by pregnant women.

In a statement, Johnson & Johnson said it divested its consumer health business and “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

Paxton took a swipe at the motives behind the spinoff, saying that Johnson & Johnson “attempted to escape responsibility by illegally offloading their liability onto a different company.”

Underlying Science

In the suit, Paxton argues that there are other drugs regulated by the Food and Drug Administration that include detailed information about potential risks on their labels, “even when the underlying science — unlike here — is not fully settled.”

The lawsuit seeks a court order barring the companies from engaging in any deceptive advertising practices while selling Tylenol in Texas and requiring them from destroying any marketing materials that say the drug is safe for pregnant women and does not increase the risk of autism. The companies could also be ordered to pay civil penalties.

Paxton, who has served as Texas Attorney General since 2015, is a longtime ally of Trump and is known for his aggressive pursuit of conservative causes in the courts. His tenure in office has also been marked by allegations of bribery and abuse of office, but he was acquitted at his impeachment trial in the state Senate in 2023.

Paxton is currently running for the US Senate in Texas, challenging fellow Republican John Cornyn for the seat he has held since 2002. Trump has yet to offer an endorsement in the race.

The Trump administration’s focus on Tylenol has stoked concern among doctors and medical experts, who have pushed back on Trump’s unsupported claims. The American College of Obstetricians and Gynecologists called Trump’s statements “irresponsible” and still recommends Tylenol for pregnant people.

Tylenol Defense

Earlier this month, Kenvue laid out its most detailed defense of Tylenol in response to a citizen petition filed last month asking for changes to the label.

The Tylenol maker said the changes “are unsupported by the scientific evidence and legally and procedurally improper,” the company said in an Oct. 17 submission to the US Food and Drug Administration.

The “overwhelming weight of the evidence” contradicts any claim that the nonprescription medicine used to treat pain and reduce fevers is a risk for neurodevelopmental disorders, the company said.

(Updates throughout with details from the lawsuit and a statement from Johnson & Johnson)

To contact the reporters on this story:
Magan Crane in Washington at mcrane19@bloomberg.net;
Redd Brown in New York at rbrown298@bloomberg.net;
Madlin Mekelburg in Austin at mmekelburg@bloomberg.net

To contact the editors responsible for this story:
Mario Parker at mparker22@bloomberg.net

Emily Cohn, Anthony Aarons

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