In a groundbreaking move, Ken Paxton, the Republican attorney general of Texas, initiated a lawsuit on Tuesday against the companies behind Tylenol, asserting they deliberately obscured information about the drug’s potential impact on children’s brain development.
This lawsuit represents the latest repercussion stemming from President Trump’s recent public statement, which suggested a connection between Tylenol use during pregnancy and autism—a link currently unsubstantiated by definitive scientific evidence.
Mr. Paxton’s suit specifically names Johnson & Johnson, which manufactured Tylenol for decades, and Kenvue, the spin-off entity that has overseen the drug’s sales since 2023.
The core of the Texas lawsuit alleges that these corporations knowingly withheld crucial evidence from consumers concerning Tylenol’s potential association with autism and attention deficit hyperactivity disorder. It further claims that Kenvue was established as a strategic maneuver to shield Johnson & Johnson from potential liabilities related to Tylenol.
This case marks the first instance of a state leveraging Mr. Trump’s assertions regarding the use of acetaminophen products, such as Tylenol, during pregnancy and their alleged connection to neurodevelopmental disorders. While a long-standing concern among some proponents of Robert F. Kennedy Jr., the nation’s top health official, these claims gained significant public attention following Mr. Trump’s remarks.
Kenvue has consistently affirmed Tylenol’s safety, explicitly refuting Mr. Trump’s claims concerning its use during pregnancy and any link to autism. In separate legal battles, Johnson & Johnson has maintained that it has always acted responsibly in informing consumers about Tylenol’s established risk of liver damage when consumed in excessive amounts.
Over recent years, hundreds of lawsuits have been brought in both state and federal courts by families contending that their children received autism or ADHD diagnoses following the use of Tylenol during pregnancy.
In the most prominent aggregation of these cases, filed in federal court, a U.S. judge in New York dismissed the complaints, citing insufficient reliable scientific evidence. The plaintiffs are currently appealing this decision, with an appellate panel hearing scheduled for November 17.
For an extended period, scientists have been investigating a potential correlation between acetaminophen and neurodevelopmental disorders; however, existing studies have yielded inconsistent results.
In September, various medical organizations voiced their opposition to the Trump administration’s warning, emphasizing that Tylenol remains the only safe pain reliever for pregnant women to manage high fevers. If left untreated, high fevers pose severe health risks to both the baby and the expectant mother.
Mr. Paxton, who is preparing for a challenge against incumbent Senator John Cornyn in next year’s Republican primary, has a history of pursuing aggressive litigation that aligns with Mr. Trump’s political agenda. His past actions include contesting the outcomes of the 2020 election, suing immigrant rights nonprofits, and attempting to remove Democratic lawmakers from office in Texas during a redistricting dispute. Despite varying success rates, Mr. Paxton’s legal endeavors have cultivated substantial support among Texas Republicans.
Last month, the Food and Drug Administration indicated its intention to request a warning on Tylenol’s label regarding a potential link to neurodevelopmental disorders. Kenvue stated its opposition to these proposed changes, arguing that current scientific evidence does not support them.
Both the Trump administration and Mr. Paxton’s lawsuit reference a recent scientific review conducted by epidemiologists from Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai. This study, which analyzed existing scientific findings without generating new data, identified some evidence of a correlation between acetaminophen use during pregnancy and the subsequent development of autism and ADHD in childhood.
More than half of the 46 studies included in this review reported a positive correlation between acetaminophen use during pregnancy and neurodevelopmental disorders in children. Nevertheless, scientists have cautioned that these studies do not definitively prove that acetaminophen causes autism, a condition known to result from a complex interaction of genetic and environmental factors.
Research indicates that pregnant women who use acetaminophen differ significantly from those who do not, particularly in their genetic profiles. A large-scale study involving nearly 2.5 million children born in Sweden found no association between acetaminophen and neurodevelopmental disorders when the mother’s genetics were taken into account.
Evaluations of the available evidence by health agencies, including the F.D.A. and the European Medicines Agency, have concluded that the results linking acetaminophen to neurodevelopmental disorders are inconclusive.
On Sunday, Mr. Trump reignited the discussion on Truth Social, his social media platform, writing, “Pregnant Women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY.”
Notably, Keller Postman, the primary law firm representing plaintiffs in personal injury cases related to Tylenol, is also acting as outside counsel for Mr. Paxton’s suit.
While the existing plaintiff cases face a high burden of proof—demonstrating that the drug directly caused neurodevelopmental disorders and warranting damages—Mr. Paxton’s lawsuit takes a different approach.
Instead, Mr. Paxton’s suit argues that Johnson & Johnson and Kenvue violated Texas law by failing to adequately inform consumers about the possible risks associated with taking Tylenol during pregnancy.
Texas courts are often challenging environments for personal injury plaintiffs. Mr. Paxton’s decision to file the case in a conservative, rural county near the Louisiana border could be a strategic move to find a court more amenable to his arguments.
Mr. Paxton’s lawsuit further alleges that Johnson & Johnson intentionally divested its consumer health business, in part, to shield itself from liability in the Tylenol-related cases. However, the complaint did not present evidence to support this specific claim.
Johnson & Johnson initially announced the spin-off in 2021, finalizing the separation in 2023. Kenvue subsequently took over many of Johnson & Johnson’s iconic consumer brands, including Tylenol, Band-Aid, and Johnson’s Baby Shampoo.
At the time of the spin-off, Johnson & Johnson stated its intention to concentrate on its more lucrative and rapidly expanding pharmaceutical and medical device sectors. The company was also concurrently embroiled in costly lawsuits concerning its role in the opioid crisis and allegations that the talc in its baby powder had caused cancer in some consumers.
Wall Street analysts did not identify the Tylenol lawsuits as a driving factor behind the spin-off, as these legal actions only gained significant momentum in 2022.