Texas Attorney General Ken Paxton files Tylenol lawsuit over autism claims

Texas Attorney General Ken Paxton has filed a lawsuit against Kenvue and Johnson & Johnson, claiming the use of Tylenol leads to higher risk of autism and that the over-the-counter drug is deceptively marketed to pregnant women as safe.  

Many medical experts have disputed such claims.

The lawsuit, dated Monday, alleges Johnson & Johnson and Tylenol maker Kenvue, which separated from Johnson & Johnson in 2023, knew for decades “that acetaminophen—Tylenol’s active ingredient—is dangerous to unborn children and young children. Yet they hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women.”

In the lawsuit, Paxton pointed to the Trump administration’s claims about acetaminophen’s risks, saying that: “the federal government confirmed what Defendants knew for years: acetaminophen use during pregnancy likely causes conditions like [autism] and [attention-deficit/hyperactivity disorder].” 

Paxton also accused Johnson & Johnson of transferring its liabilities arising from Tylenol to Kenvue in order to shield its assets from potential lawsuits related to Tylenol and its alleged “harmful impact” on children. 

Kenvue said in a statement that Texas’ claims “lack legal merit and scientific support” and vowed to defend itself in litigation. It maintained that acetaminophen “is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.” 

“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,” Kenvue said.

Kenvue also warned that failing to treat fevers and other ailments with acetaminophen could also expose pregnant women to health risks. 

“Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives,” Kenvue’s statement continued. “High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.”

A Johnson & Johnson spokesperson said in a statement to CBS News: “Johnson & Johnson divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

In September, President Trump, standing alongside Health and Human Services Secretary Robert F.  Kennedy Jr., announced the FDA would immediately notify physicians “that the use of acetaminophen during pregnancy can be associated with a very increased risk of autism.”

Kennedy said the FDA based its decision on studies that “suggest a potential association between acetaminophen used during pregnancy and adverse neurodevelopmental outcomes,” including one study in the public health journal Environmental Health. He added that “NIH [National Institutes of Health] research teams are currently testing multiple hypotheses.”

After the Trump administration issued its warning about Tylenol, many top medical experts in the field stressed that scientific evidence does not support such concerns. The American College of Obstetricians and Gynecologists said in a statement provided to CBS News that “there is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues.”   

—Marc Schwartz contributed to this article.