Texas Attorney General Ken Paxton has filed a groundbreaking lawsuit against Johnson & Johnson and its spinoff Kenvue, alleging the pharmaceutical giants concealed potential connections between Tylenol use during pregnancy and developmental disorders in children, including autism spectrum disorder (ASD) and attention deficit/hyperactivity disorder (ADHD). This legal action represents the first state government lawsuit following recent federal statements about acetaminophen safety concerns during pregnancy.
Allegations Raised in the Texas Tylenol Autism Lawsuit
This new Tylenol lawsuit, filed in Texas state court, contends that the manufacturers of Tylenol engaged in deceptive marketing practices by promoting the popular pain reliever as safe for pregnant women despite allegedly knowing about potential risks to fetal development. According to court documents, Attorney General Paxton claims the companies “willfully ignored and attempted to silence the science” regarding prenatal acetaminophen exposure and its possible connection to neurodevelopmental conditions.
At the center of this lawsuit is acetaminophen, Tylenol’s active ingredient, which has been widely recommended as the safest pain relief option for expectant mothers. The Texas Attorney General’s office alleges that internal research conducted by Johnson & Johnson as early as 2014 indicated a potential link between acetaminophen and ASD/ADHD, yet this information was allegedly withheld from consumers.
The lawsuit further accuses Johnson & Johnson of fraudulently transferring its Tylenol-related liabilities to Kenvue during the 2023 spinoff to shield itself from potential litigation. This strategic corporate restructuring allegedly aimed to protect Johnson & Johnson’s assets from what the lawsuit describes as “tens of billions of dollars in damages to permanently injured children.”
Federal Statements on Acetaminophen Safety
The timing of this lawsuit follows closely behind controversial statements from the Trump administration regarding acetaminophen safety in pregnancy. In September 2025, President Donald Trump, alongside Health and Human Services Secretary Robert F. Kennedy Jr., announced that the FDA would notify physicians about potential risks associated with Tylenol use during pregnancy.
Researching Linking Tylenol Use and Autism
During this announcement, federal officials referenced an August 2025 meta-analysis conducted by researchers from prestigious institutions, including Mount Sinai, Harvard, UCLA, and UMass Lowell. This analysis suggested prenatal exposure to acetaminophen might increase the risk of neurodevelopmental disorders in children. While the authors of this meta-analysis did not conclude that Tylenol use is a direct cause of autism, nor did they recommend pregnant women avoid the medication entirely, they did state that “Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.”
FDA Updating the Tylenol Safety Label
The FDA has since initiated a process to update Tylenol’s labeling to note that prenatal acetaminophen use “may be associated” with an increased risk of certain developmental disorders. However, the agency explicitly stated that “a causal relationship has not been established” between the medication and autism or ADHD.
Corporate Response to the Tylenol Lawsuit
Both companies named in the lawsuit brought by the Texas AG have issued statements defending their products and practices. Kenvue expressed deep concern about “the perpetuation of misinformation on the safety of acetaminophen” and the potential impact on women’s and children’s health. The company emphasized that acetaminophen remains “the safest pain reliever option for pregnant women” throughout pregnancy.
Kenvue further warned that without access to acetaminophen, pregnant women face difficult choices: endure potentially harmful fevers and pain or resort to riskier alternatives. The company has vowed to “vigorously defend” itself against what it describes as “baseless claims” that “lack legal merit and scientific support.”
Johnson & Johnson, for its part, has distanced itself from the controversy, stating that it “divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol, are owned by Kenvue.”
Previous Litigation Involving Tylenol and Autism
The Texas lawsuit is not the first legal challenge concerning acetaminophen and neurodevelopmental disorders. In 2022, parents of children with autism and ADHD began suing the makers of Tylenol and generic acetaminophen medications, claiming inadequate warnings about potential health risks when used during pregnancy.
These consolidated claims were dismissed in 2023 when a federal judge ruled that the testimony and research presented by the plaintiffs’ expert witnesses were not conclusive. That ruling is currently under appeal, with hearings scheduled for November in New York.
Potential Implications for Pregnant Women
The conflicting messages from political figures, pharmaceutical companies, and medical organizations create a challenging landscape for pregnant women seeking safe pain relief options. Medical experts emphasize that untreated pain and fever during pregnancy can pose significant risks to both mother and baby.
While the Tylenol autism lawsuit and surrounding controversy continue to unfold, healthcare providers generally advise that pregnant women should:
- Consult with their healthcare providers before taking any medication
- Use acetaminophen at the lowest effective dose for the shortest time necessary
- Be aware that no pain reliever is completely without risk
- Consider non-pharmaceutical approaches to pain management when appropriate
Looking Forward: The Future of the Tylenol Lawsuit
As this Tylenol lawsuit progresses, it will likely prompt further research into the safety of acetaminophen during pregnancy. The outcome could potentially influence pharmaceutical labeling requirements, medical practice guidelines, and consumer awareness about medication safety during pregnancy.
The Texas lawsuit also highlights the complex intersection of science, medicine, law, and politics in public health matters. Regardless of the lawsuit’s outcome, it underscores the importance of transparent communication between pharmaceutical companies, regulatory agencies, healthcare providers, and patients regarding medication risks and benefits.
Tylenol Lawsuit Information
Prenatal and postnatal exposure to acetaminophen in relation to autism spectrum and attention-deficit and hyperactivity symptoms in childhood: Meta-analysis in six European population-based cohorts, European Journal of Epidemiology
Tylenol Lawsuit, Texas Attorney General
President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism Epidemic, Department of Health and Human Services
Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology, Environmental Health
