Texas Attorney General Ken Paxton announced he is suing the makers of Tylenol, claiming the companies failed to warn consumers about the risks of taking the drug while pregnant.

Paxton filed a lawsuit against pharmaceutical giant Johnson & Johnson and its spin-off company Kenvue, claiming the companies "willfully ignored and attempted to silence the science" connecting Tylenol to autism and attention deficit hyperactivity disorder, violating the state's consumer protection laws.

The suit also claims Johnson & Johnson broke the law by transferring liability to Kenvue, which spun off in 2023, to shield their assets against lawsuits.

"These corporations lied for decades, knowingly endangering millions to line their pockets," Paxton said in a statement Oct. 28. "Additionally, seeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company. By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again."

The lawsuit comes just over a month after President Donald Trump and his top health officials urged pregnant women to stop taking Tylenol as he promoted an unproven link between the painkiller and a rise in autism among children.

Experts say multiple factors, including genetics, contribute to the development of autism. Several medical organizations have pushed back on the Tylenol autism claim.

"Unfortunately, governmental officials have been touting the few observational studies that do suggest a potential link between prenatal acetaminophen use and autism ... As healthcare professionals, it's critical for us to emphasize to patients the limitations in these studies and to highlight that no causal relationship has been established," American College of Obstetricians and Gynecologists President Steven Fleischman wrote in a MedPage Today perspective published Oct. 25.

Tylenol maker says claims are 'baseless'

Acetaminophen, the generic form of Tylenol, "is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy," Kenvue said in a statement to USA TODAY. The company said it is "deeply concerned by the perpetuation of misinformation" about the drug's safety.

"We will defend ourselves against these baseless claims and respond per the legal process," the company's statement said. "We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support."

Johnson & Johnson said in a statement that the company "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."

Heightened controversy over acetaminophen and autism

At a news conference Sept. 22 alongside Health and Human Services Secretary Robert F. Kennedy Jr., Trump linked Tylenol to an increased risk of autism and urged expecting mothers to "fight like hell not to take it."

More than two dozen studies have linked a pregnant person's frequent use of acetaminophen to autism and attention-deficit hyperactivity disorder in their child, including a report published in August in BMC Environmental Health.

But several studies have found competing evidence. That includes a 2024 study in Sweden of about 2 million children, more than 180,000 of whom were exposed to acetaminophen during pregnancy, which found no associations between the pain medication and children’s risk of autism, ADHD or intellectual disability.

The Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists have endorsed the use of acetaminophen during pregnancy.

Fleischman said a Tylenol label change "highlighting the unfounded risk will only add to the growing fear and confusion" about the over-the-counter medication’s use during pregnancy.

Fleischman wrote patients are "hearing the misleading warnings from the government" and fear they could be doing something wrong by taking Tylenol during pregnancy.

"That couldn't be further from the truth," Fleischman wrote. "In fact, by avoiding acetaminophen during pregnancy, they may unintentionally expose their fetus to the very harms they seek to prevent, or potentially even greater risks."

FDA Commissioner Marty Makary said in a letter to doctors nationwide that "while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature." Still, the Food and Drug Administration announced it initiated steps to change the label for acetaminophen "to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk" of autism and ADHD in children.

A citizen petition has also recently been filed requesting a warning be added to the label of the drug, which Kenvue has urged the FDA to reject.

The Texas suit claims the companies "had the authority and the duty" to update their own labels but have taken no steps to do so. If they had, the suit claims, pregnant Texans would have reduced or eliminated acetaminophen consumption.

"Defying the recommendations of our Nation’s public-health officials, Defendants practically encourage women to disregard the warnings of the Secretary of Health and Human Services and the Commissioner of Food and Drugs," the lawsuit says.

Dozens of people have sued Johnson & Johnson, generic manufacturers and major retailers alleging developmental injuries such as autism and ADHD due to mothers' prenatal use of acetaminophen.

Those cases, still making their way through federal court, have been consolidated into multi-district litigation under a federal judge in the Southern District of New York.

That litigation centers on personal injury claims, but the Texas suit relies on two state consumer protection laws, which mean "a different burden of proof and different damages that we’re going to be seeking," Ashley Keller, the attorney involved in both cases, told The Texas Tribune.

This story has been updated to add new information.

Contributing: Adrianna Rodriguez, USA TODAY; Reuters

This article originally appeared on USA TODAY: Texas suing makers of Tylenol over alleged autism link

Reporting by N'dea Yancey-Bragg and Ken Alltucker, USA TODAY / USA TODAY

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