In a move that has sent shockwaves through the pharmaceutical industry and the medical community, Texas Attorney General Ken Paxton has launched a high-stakes lawsuit against Johnson & Johnson and its spinoff, Kenvue, alleging they knowingly concealed potential links between Tylenol (acetaminophen) use during pregnancy and subsequent neurodevelopmental disorders like autism and ADHD. This legal challenge, following controversial claims by President Donald Trump and ongoing private litigation, spotlights a deepening divide between scientific consensus and public concern, with profound implications for pregnant women, healthcare providers, and the future of over-the-counter medication.
The controversy surrounding the popular pain reliever Tylenol, known generically as acetaminophen, reached a fever pitch on October 28, 2025, when Texas Attorney General Ken Paxton filed a lawsuit against its makers, Johnson & Johnson and Kenvue. The lawsuit claims that the companies intentionally hid evidence of the drug’s supposed links to autism and attention deficit hyperactivity disorder (ADHD) in children whose mothers used it during pregnancy. This legal action escalates a long-standing debate and adds significant weight to a series of private lawsuits already in progress.
The timing of the lawsuit is particularly notable, coming five weeks after President Donald Trump publicly stated that using Tylenol during pregnancy can cause autism. While Trump’s claims are unproven and unsupported by scientific evidence, his statements have undoubtedly amplified public concern and added a political dimension to the medical discussion.
The Core Allegations: Concealment and Deception
Paxton’s complaint, filed in a state court in rural Panola County, alleges that Johnson & Johnson and Kenvue violated Texas law against deceptive trade practices by concealing the risks associated with acetaminophen use during pregnancy. He further accused Johnson & Johnson of violating Texas law against fraudulent transfers by spinning off Kenvue in 2023, suggesting it was an attempt to shield itself from potential liability.
According to the lawsuit, the federal government last month “confirmed” that acetaminophen use during pregnancy is more likely to cause autism and ADHD, and that despite “overwhelming evidence,” the companies failed to warn pregnant women. Paxton also highlighted President Trump’s repeated warnings to avoid Tylenol unless “absolutely necessary.”
For decades, Johnson & Johnson sold Tylenol before spinning off its consumer health division into Kenvue in 2023. Kenvue has since been responsible for the brand, and it quickly issued a statement defending the product’s safety. “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” Kenvue stated, expressing deep concern about the “perpetuation of misinformation” regarding the drug’s safety. Johnson & Johnson, for its part, asserted that Kenvue is responsible for “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol,” as reported by Reuters.
The Scientific & Medical Consensus vs. Emerging Concerns
Despite the legal and political claims, the established scientific and medical communities largely maintain a different stance. Doctors and major medical societies globally continue to recommend acetaminophen as the preferred and safest option for treating fever and pain during pregnancy. Organizations like Health Canada and the Society of Obstetricians and Gynaecologists of Canada have reiterated that there is no conclusive evidence linking directed acetaminophen use during pregnancy to autism or other neurodevelopmental disorders, as detailed by CBC News.
However, the debate is not entirely without scientific underpinnings. While not conclusive, some studies have explored a potential connection between acetaminophen and neurodevelopmental disorders. A scientific review cited by both the Trump administration and Paxton’s suit, conducted by epidemiologists from Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai, evaluated existing findings and found evidence of a link between acetaminophen use during pregnancy and the development of autism and ADHD in childhood. Yet, scientists caution that these studies do not definitively prove causation, highlighting the complex interplay of genetics and environmental factors in autism. Furthermore, studies by health agencies like the FDA and the European Medicines Agency have generally found the evidence to be inconclusive.
Last month, the U.S. Food and Drug Administration (FDA) indicated it would seek new warning labels for acetaminophen to reflect potential associations with neurodevelopmental disorders. Kenvue, however, stated its intention to oppose these changes, arguing they are “not supported by the existing science.”
Political Undercurrents and Broader Legal Landscape
The lawsuit is not an isolated event but part of a larger political and legal movement. Attorney General Ken Paxton, a Republican who plans to challenge incumbent Senator John Cornyn next year, has positioned himself as a strong supporter of President Trump’s agenda. His decision to file the case in Panola County, where Trump won 83% of the vote in the 2024 presidential election, is seen by some as a strategic move to find a sympathetic court, according to reporting by The New York Times.
Concerns about autism have also been a long-standing issue for Robert F. Kennedy Jr., currently the U.S. Secretary of Health and Human Services, whose agencies include the FDA. His involvement further elevates the profile and political resonance of this health debate.
The Texas lawsuit joins hundreds of private lawsuits filed by families claiming their children developed autism or ADHD due to maternal Tylenol use. Many of these cases were dismissed by a federal judge last December, but an appeal is scheduled to be heard on November 17. The law firm Keller Postman, representing families in the appeal, is also assisting Paxton in his current case.
This situation also echoes other significant legal challenges faced by Johnson & Johnson. The company is separately dealing with more than 73,000 plaintiffs alleging cancer diagnoses from its baby powder and talc products, cases that federal courts have repeatedly blocked the company from resolving through bankruptcy. Interestingly, concerns about Tylenol’s safety did not gain significant traction until after Johnson & Johnson announced the Kenvue spinoff in 2021.
What This Means for the Future of Tylenol
The Texas lawsuit, combined with ongoing private litigation and political discourse, underscores a critical juncture for Tylenol and acetaminophen. While medical professionals continue to uphold its safety for pregnant women when used as directed, the persistent claims and legal challenges could lead to increased scrutiny, potential label changes, and a shift in public perception.
The outcome of Paxton’s lawsuit and the federal appeals for private cases will be crucial in shaping future regulatory actions and determining the scope of corporate liability for over-the-counter medications. For now, the debate remains fiercely contested, leaving consumers navigating conflicting information about a drug widely considered a household staple.
