The Republican Attorney General of Texas, Ken Paxton, has initiated a lawsuit against the manufacturers of Tylenol, alleging that these companies intentionally withheld information regarding the drug’s potential effects on children’s brain development.
This legal action comes on the heels of recent claims by former President Trump, who suggested a connection between Tylenol use during pregnancy and autism. It’s crucial to note that this link remains scientifically unproven.
Mr. Paxton’s suit targets both Johnson & Johnson, the long-time seller of Tylenol, and Kenvue, the spin-off company that has distributed the drug since 2023.
The core of the Texas lawsuit alleges that the companies deliberately kept consumers in the dark about Tylenol’s associations with autism and attention deficit hyperactivity disorder (ADHD). Furthermore, it claims that Kenvue was strategically established to shield Johnson & Johnson from future liability related to Tylenol.
This marks the first state-level lawsuit to echo Mr. Trump’s assertions about acetaminophen products like Tylenol potentially causing neurodevelopmental disorders during pregnancy. While this concern has long resonated with some followers of Robert F. Kennedy Jr., currently the nation’s top health official, Mr. Trump’s comments significantly amplified its public profile.
Kenvue has consistently maintained Tylenol’s safety, refuting Mr. Trump’s claims regarding its use in pregnancy and autism. In separate legal battles, Johnson & Johnson has stated its commitment to responsibly warning consumers about Tylenol’s well-established risk of liver damage if taken in excessive amounts.
Clare Boyle, a spokeswoman for Johnson & Johnson, confirmed 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.”
In recent years, hundreds of lawsuits have been filed in state and federal courts by families claiming their children developed autism or ADHD after prenatal Tylenol exposure.
In federal court, the largest collection of these cases was dismissed by a U.S. judge in New York due to insufficient reliable scientific evidence. The plaintiffs are currently appealing this decision, with an appellate panel hearing scheduled for November 17th.
For years, researchers have investigated a possible connection between acetaminophen and neurodevelopmental disorders, but their studies have yielded inconsistent findings.
In September, medical organizations voiced strong opposition to the Trump administration’s warning, emphasizing that Tylenol remains the safest pain reliever for pregnant women to manage high fevers. Untreated fevers can pose serious health risks to both mother and baby.
Mr. Paxton, who plans to challenge incumbent Senator John Cornyn in next year’s Republican primary, has a history of pursuing litigation that aligns with Mr. Trump’s political agenda. His previous legal actions include challenging the 2020 election results, suing immigrant rights organizations, and attempting to remove Democratic lawmakers in Texas during redistricting disputes. While not always successful, these efforts have solidified his support among Texas Republicans.
Last month, the Food and Drug Administration (FDA) indicated it was considering adding a warning to Tylenol’s label about a potential link to neurodevelopmental disorders. Kenvue has publicly stated its intention to oppose these changes, arguing they are “not supported by the existing science.”
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 review, which synthesized existing research rather than producing new data, suggested a link between acetaminophen use during pregnancy and the development of autism and ADHD in childhood.
Over half of the 46 studies examined in the review identified a positive correlation between prenatal acetaminophen use and neurodevelopmental disorders in children. However, scientists have consistently cautioned that these studies do not definitively prove that acetaminophen *causes* autism, a condition known to be influenced by a complex interplay of genetic and environmental factors.
Pregnant women who use acetaminophen often differ significantly from those who do not, including in their genetic predispositions. For instance, a substantial study of nearly 2.5 million children born in Sweden found no association between acetaminophen use and neurodevelopmental disorders when maternal genetics were taken into account.
Health agencies, including the FDA and the European Medicines Agency, have reviewed the available evidence and concluded that the results remain inconclusive.
On Sunday, Mr. Trump reiterated his concerns on Truth Social, urging: “Pregnant Women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY.”
The law firm primarily representing plaintiffs in ongoing personal injury cases, Keller Postman, is also serving as external counsel for Mr. Paxton’s suit.
These plaintiff cases face the difficult challenge of proving that the drug directly caused neurodevelopmental disorders in children to secure damages for families.
However, Mr. Paxton’s lawsuit adopts a different legal strategy, contending that Johnson & Johnson and Kenvue violated Texas law by failing to adequately inform consumers about the potential risks of taking Tylenol during pregnancy.
Texas courts are notoriously challenging for plaintiffs in personal injury cases. Mr. Paxton’s decision to file this case in a conservative, rural county near the Louisiana border might be a strategic attempt to find a more favorable judicial environment.
Mr. Paxton’s suit further claims that Johnson & Johnson deliberately spun off its consumer health division, at least partially, to shield itself from liability in the numerous Tylenol-related cases. The complaint, however, did not offer specific evidence to support this assertion.
Johnson & Johnson first announced the spin-off in 2021, finalizing it in 2023. Kenvue subsequently acquired popular and historic Johnson & Johnson brands such as Tylenol, Band-Aid, and Johnson’s Baby Shampoo.
At the time, Johnson & Johnson explained its move as a strategic decision to concentrate on its more profitable and rapidly expanding pharmaceutical and medical device sectors. The company was simultaneously grappling with costly lawsuits concerning its role in the opioid crisis and allegations that talc in its baby powder caused cancer in some users.
Notably, Wall Street analysts did not identify the Tylenol lawsuits as a primary driver for the spin-off, as these specific legal actions gained significant momentum starting in 2022.