In a significant move, Ken Paxton, the Republican attorney general of Texas, has launched a lawsuit against the manufacturers of Tylenol. The suit, filed on Tuesday, alleges that these companies deliberately concealed information regarding the potential risks of the popular pain reliever on children’s brain development.
This legal action comes on the heels of recent claims by President Trump, who suggested last month that Tylenol use during pregnancy could lead to autism. It’s important to note that this purported link remains scientifically unproven.
The lawsuit targets both Johnson & Johnson, the long-time seller of Tylenol, and Kenvue, the spin-off company that took over sales of the drug in 2023.
At the core of the Texas lawsuit is the accusation that both companies knowingly suppressed evidence connecting Tylenol to autism and Attention Deficit Hyperactivity Disorder (ADHD). Furthermore, the suit contends that Kenvue’s establishment was a strategic maneuver to insulate Johnson & Johnson from potential Tylenol-related liabilities.
This marks the first instance of a state formally pursuing legal action based on Mr. Trump’s assertions that acetaminophen-based products, including Tylenol, might contribute to neurodevelopmental disorders when used during pregnancy. While this concern has long been voiced by some supporters of Robert F. Kennedy Jr., a prominent health official, Mr. Trump’s recent comments significantly amplified its public profile.
Kenvue has consistently maintained Tylenol’s safety, strongly refuting Mr. Trump’s claims regarding its link to autism during pregnancy. Johnson & Johnson, in separate legal battles, has always asserted its responsibility in educating consumers about Tylenol’s established risk of liver damage if dosage instructions are not followed.
In recent years, numerous lawsuits have been initiated in both state and federal courts by families alleging that their children developed autism or ADHD following Tylenol exposure during pregnancy.
However, in the most substantial cluster of these cases, a federal judge in New York dismissed the claims, citing insufficient reliable scientific evidence. The plaintiffs are currently appealing this ruling, with an appellate hearing set for November 17.
For an extended period, scientists have been investigating a possible connection between acetaminophen and neurodevelopmental disorders, though the research to date has yielded inconsistent findings.
In September, various medical organizations countered the Trump administration’s warning, emphasizing that Tylenol remains the only safe pain reliever for pregnant women to manage high fevers. Untreated fevers, they cautioned, present significant health risks to both mother and baby.
Known for his aggressive legal strategy, Mr. Paxton, who will challenge incumbent Senator John Cornyn in next year’s Republican primary, has frequently initiated lawsuits mirroring Mr. Trump’s political agenda. His past actions include disputing the 2020 election results, suing immigrant rights organizations, and attempting to oust Democratic lawmakers in Texas during redistricting disputes. While not all his legal battles have been victorious, his consistent alignment with conservative causes has garnered him significant support among Texas Republicans.
Just last month, the Food and Drug Administration (FDA) indicated its intention to add a warning to Tylenol’s label regarding a potential link to neurodevelopmental disorders. Kenvue, however, quickly announced its opposition, asserting that such changes are “not supported by the existing science.”
Both the Trump administration and Mr. Paxton’s lawsuit draw upon a recent scientific review. This review, carried out by epidemiologists from Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai, synthesized existing research rather than generating new data. It concluded that there was evidence suggesting a link between acetaminophen use during pregnancy and the development of autism and ADHD in children.
While over half of the 46 studies examined in the review indicated a positive correlation between prenatal acetaminophen use and neurodevelopmental disorders, scientists are quick to emphasize that these studies do not definitively prove causation. Autism, for instance, is understood to arise from a complex interaction of genetic and environmental elements.
It’s also crucial to consider that pregnant women who use acetaminophen may have significant differences from those who do not, including genetic predispositions. A large-scale study involving nearly 2.5 million Swedish children, for example, found no association between acetaminophen use and neurodevelopmental disorders once the mothers’ genetics were factored in.
Furthermore, major health authorities, such as the FDA and the European Medicines Agency, have thoroughly assessed the available evidence and consistently found the results to be inconclusive.
On Sunday, Mr. Trump reiterated his concerns on his social media platform, Truth Social, urging: “Pregnant Women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY.”
Notably, Keller Postman, the primary law firm representing plaintiffs in the existing personal injury cases, is also acting as outside counsel for Mr. Paxton’s new lawsuit.
These ongoing plaintiff cases face the challenging requirement of proving a direct causal link between the drug and neurodevelopmental disorders in children, and subsequently, that families are entitled to damages.
However, Mr. Paxton’s lawsuit adopts a different strategy: it argues that Johnson & Johnson and Kenvue breached Texas law by failing to adequately inform consumers about the possible risks associated with Tylenol use during pregnancy.
Texas courts are often difficult for plaintiffs in personal injury claims. Mr. Paxton’s choice to file this case in a conservative, rural county near the Louisiana border is seen by some as a strategic maneuver to secure a more favorable legal environment for his arguments.
The lawsuit further alleges that Johnson & Johnson deliberately spun off its consumer health division, in part, to protect itself from potential liabilities arising from the Tylenol cases. The complaint, however, does not present evidence to substantiate this specific claim.
Johnson & Johnson had initially announced this corporate spin-off in 2021, with the separation finalized in 2023. Kenvue subsequently acquired many of Johnson & Johnson’s iconic consumer brands, including Tylenol, Band-Aid, and Johnson’s Baby Shampoo.
At the time of the split, Johnson & Johnson stated its intention to concentrate on its more lucrative and rapidly expanding pharmaceutical and medical device sectors. The company was also confronting significant legal challenges, including costly lawsuits related to the opioid crisis and allegations that talc in its baby powder caused cancer.
Interestingly, Wall Street analysts largely discounted Tylenol-related litigation as a primary driver for the spin-off, noting that these lawsuits only gained significant momentum in 2022.