Texas lawsuit against companies behind Tylenol asserts unproven claims of autism risk

Texas Attorney General Ken Paxton on Tuesday accused the companies behind Tylenol of deceptively marketing the pain reliever to pregnant mothers in a lawsuit that asserted unproven claims that early exposure to acetaminophen increased risk of autism and other disorders.

Paxton, an ally of President Donald Trump and a Republican candidate for U.S. Senate, announced the suit against Johnson & Johnson and Kenvue weeks after Trump and Health Secretary Robert F. Kennedy Jr. asserted an unproven link between the pain reliever and autism while announcing a wide-ranging effort to study the causes of the complex brain disorder.

The suit alleges that the companies violated Texas consumer protection laws by hiding the danger that acetaminophen, the active ingredient in Tylenol, posed to fetuses and young children and “deceptively marketed Tylenol as the only safe painkiller for pregnant women.”

It also alleges that Johnson & Johnson fraudulently transferred liabilities arising from Tylenol to Kenvue to shield assets against lawsuits.

In 2021, New Brunswick, New Jersey-based J&J, announced that it would turn its consumer health business, which makes Tylenol and other products, into a separate company now known as Kenvue. It referenced that divestment in a statement Tuesday, saying “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. These corporations lied for decades, knowingly endangering millions to line their pockets,” Paxton said in a statement. “Additionally, seeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company.”

Acetaminophen has long been one of the most popular pain relievers and fever reducers in the U.S., used by upward of 100 million Americans annually. Some studies have raised the possibility that taking Tylenol in pregnancy might be associated with a risk of autism — but many others haven’t found a connection.

Kenvue stressed in a statement Tuesday that acetaminophen is the safest pain reliever option for pregnant women, noting that high fevers and pain are recognized as potential risks to pregnancies if left untreated. The Summit, New Jersey-based company said it would defend itself against the claims and expressed concern about the “perpetuation of misinformation” about acetaminophen’s safety and the potential impact on the health of women and children.

“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,” Kenvue said.

Kenvue has said it faces litigation in federal court over the autism claims, noting earlier this year in an annual filing that many of those claims have been dismissed but are being appealed.