Kenvue Braces for Wave of New Lawsuits Over Tylenol’s Potential Link to Autism
The Trump administration warned about the risk of use during pregnancy, which the company disputes
- Kenvue faces potential lawsuits over Tylenol after the Trump administration warned the drug’s active ingredient might cause autism.
- A prior federal judge ruling that dismissed lawsuits was appealed. The new warning could revive the federal lawsuits.
- Despite the warning potentially hurting sales, Kenvue maintains Tylenol is safe, citing science showing no clear autism link.
Kenvue is preparing for an explosion of litigation over its popular pain reliever Tylenol after the Trump administration warned that the drug’s active ingredient is a potential cause of autism.
The finding by President Trump’s health officials, which Kenvue and some medical societies dispute, could provide ammunition to plaintiffs’ attorneys who are seeking to reverse losses in older lawsuits alleging the medicine caused the neurodevelopmental disorders. And it could unleash thousands of new lawsuits in the coming years, people familiar with the matter say.
Trump and Health Secretary Robert F. Kennedy Jr. said Monday that prenatal exposure to acetaminophen—the active ingredient of Tylenol and other medications—is a potential cause of autism.
“Don’t take it,” said Trump several times at a press conference, occasionally adding a qualifier that pregnant women could take it if absolutely necessary.
The Food and Drug Administration is notifying physicians of the potential link, and recommending that pregnant women use the lowest dose and for the shortest duration if their doctors determine it is necessary for pain or fever. The FDA also will begin the process to change the safety warnings in the product label for acetaminophen medicines.
The FDA is acknowledging that there are contrary studies showing no association, and that there can be risks for untreated fever in pregnancy for both the mother and the fetus.
Kenvue is the over-the-counter products company that was spun out of Johnson & Johnson in 2023. Tylenol, one of the most widely used OTC medicines, is a top-selling product for Kenvue, generating an estimated 10% of the company’s $15 billion in annual sales, according to BNP Paribas analyst Navann Ty.
While the new federal warning on the link to autism could hurt sales, the sales impact might be modest because pregnant women’s use of Tylenol makes up only a small part of the product’s sales.
The bigger complication for Kenvue may be an increase in the lawsuits alleging Tylenol caused autism in children whose mothers used it during pregnancy.
About 500 lawsuits were filed against J&J and later Kenvue—and other companies selling private-label products—starting in 2022 alleging prenatal exposure to acetaminophen caused autism or attention-deficit hyperactivity disorder. Kenvue inherited the Tylenol-related litigation as a stand-alone company.
But to date, Kenvue has been successful in fending off the lawsuits. In 2023, a federal judge ruled there wasn’t sufficient evidence that acetaminophen caused autism, and the lawsuits were dismissed.
Plaintiffs’ lawyers have appealed that 2023 ruling in a bid to revive the federal lawsuits. They will now likely include the Trump administration’s warning in their argument to the appellate court that the lower court dismissals should be reserved. A hearing in the appeal was originally scheduled for early October but on Monday the court notified lawyers it was being pushed back to mid-November.
Even if the federal lawsuits aren’t revived, the new federal warning could prompt thousands of lawsuits to be filed in state courts. Plaintiffs’ attorneys represent tens of thousands of families with autistic children who haven’t yet filed lawsuits, according to Ashley Keller, a senior partner with the law firm of Keller Postman, who represents families in the Tylenol-autism litigation. Under the law, the statute of limitations for filing lawsuits on behalf of minors is paused until they turn 18, which means the lawsuits could roll in for many years to come.
“If there’s a call to action or a change in public health guidelines, of course plaintiffs’ lawyers are going to take note of that and see if that influences their decision to represent clients harmed,” said Keller.
A label change warning of the potential risk could pose a challenge for Kenvue because it could strengthen plaintiffs’ arguments that the company failed to warn of the risk.
Kenvue says Tylenol is safe and that the science shows no clear link between it and autism.
Kenvue said in a written statement Monday that it believes “independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
Kenvue said acetaminophen is the safest pain reliever option for pregnant women as needed through their pregnancy. If they don’t take it, there is a risk that an untreated fever could cause a miscarriage or autism or birth defects in their children.
“We will continue to explore all options to protect the health interests of American women and children,” the company said.
Kenvue shares fell 7.5% Monday in regular trading, but rose about 5% in after-hours trading after Trump released the news.
During Trump’s press conference, the Department of Health and Human Services released written statements about the moves that used more tempered language than Trump’s and Kennedy’s comments. The letter from FDA Commissioner Martin Makary to doctors, for instance, said that “a causal relationship has not been established,” and it described acetaminophen as the “safest over-the-counter alternative in pregnancy.”