Johnson & Johnson, which makes Tylenol, and its spin-off company Kenvue, which has sold the medication since 2023, are being sued by the Attorney-General of Texas, Ken Paxton, who accuses them of deliberately concealing the risks of the drug on brain development of children.
The lawsuit – the latest fallout from the Trump administration’s unproven claim last month that using Tylenol during pregnancy can cause autism – claims the companies knowingly withheld evidence the information about Tylenol’s links to autism and attention deficit hyperactivity disorder (ADHD).
It further claims that Kenvue was created specifically to shield J&J from liability over Tylenol, reports The New York Times.
The legal action is the first by a state seizing on allegations that acetaminophen – known in South Africa as paracetamol – products like Tylenol during pregnancy could cause neurodevelopmental disorders.
Kenvue has repeatedly defended Tylenol’s safety and rejected Donald Trump’s claims about the drug’s use during pregnancy and autism.
“We will defend ourselves against these baseless claims, and respond per the legal process,” said a Kenvue spokesperson.
“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.”
In other litigation, J&J has said it had always acted responsibly in warning consumers about Tylenol’s proven risk of liver damage when taken in excess.
A spokeswoman for J&J said on Tuesday 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”.
Hundreds of lawsuits in state and federal courts have been filed in recent years by families claiming their children were diagnosed with autism or ADHD after Tylenol had been used during pregnancy.
In the largest group of cases, a judge in New York dismissed the lawsuits, citing a lack of reliable scientific evidence. The plaintiffs are appealing the decision, with a hearing in front of an appellate panel scheduled for 17 November.
For years, scientists have conducted research on a potential connection between acetaminophen and neurodevelopmental disorders, but the studies have so far produced mixed results.
Medical groups pushed back against the Trump administration’s warning in September, saying Tylenol was the only pain reliever safe for use during pregnancy to treat high fevers. If untreated, fevers can pose serious risks to the health of the baby and the mother.
Molly Meegan, general counsel of the American College of Obstetricians and Gynaecologists, called the Texas lawsuit “a misrepresentation” of the science.
“The most robust studies of the past two decades have continued to demonstrate that acetaminophen does not cause autism, and that it can play a medically important role in the care ob-gyns provide to their pregnant patients,” she said.
Last month, the FDA said it was seeking to include a warning on the Tylenol label about the connection to neurodevelopmental disorders. Kenvue said it would oppose the changes, arguing that they were “not supported by existing science”.
The Trump administration and Paxton's suit both cite a recent scientific review conducted by epidemiologists at Harvard’s TH Chan School of Public Health and the Icahn School of Medicine at Mount Sinai. That study, which evaluated existing scientific findings but did not produce new data, found evidence of a link between acetaminophen use during pregnancy and the development of autism and ADHD in childhood.
More than half of the 46 studies included in the review found a positive correlation between use of the drug during pregnancy and neurodevelopmental disorders in children. But scientists have cautioned that the studies do not prove that acetaminophen causes autism, which is known to be linked to a complex interplay of genetics and environmental factors.
Pregnant women who take acetaminophen may differ in important ways from those who don’t, including in their genetics. One major study of nearly 2.5m children born in Sweden found that, when accounting for the mother’s genetics, there was no association between acetaminophen and neurodevelopmental disorders.
Studies by health agencies, including the FDA and the European Medicines Agency, have evaluated the evidence and found that the results are inconclusive.
The main law firm representing plaintiffs in the personal injury cases, Keller Postman, is also serving as outside counsel on Paxton’s suit.
Those plaintiff cases must clear the high bar of showing that the drug caused neurodevelopmental disorders in children and that families should be awarded damages as a result.
But Paxton’s suit pursues a different tack by arguing that J&J and Kenvue violated Texas law by not informing consumers of the possible risks of taking Tylenol during pregnancy.
His suit also claims that J&J intentionally spun off its consumer health business, at least in part, to shield itself from liability in the cases against Tylenol. The complaint did not provide evidence for that claim.
J&J announced the spinoff in 2021, and the split was finalised in 2023. Kenvue absorbed J&J’s well-known and nostalgic brands like Tylenol, Band-Aid and Johnson’s Baby Shampoo.
At the time, J&J said that it was looking to focus on its more profitable and faster-growing businesses in pharmaceuticals and medical devices. The company was also facing hugely expensive lawsuits over its role in the opioid epidemic and over accusations that the talc once used in its baby powder had caused cancer in some customers.
Wall Street analysts did not consider Tylenol to have motivated the spinoff. The Tylenol lawsuits picked up steam in 2022.
See more from MedicalBrief archives:
New FDA Tylenol advice a potential boost for autism lawsuits
SA expert groups dismiss Trump’s paracetamol link to autism
Too soon to dismiss concerns about acetaminophen and autism?