Texas Sues J&J, Kenvue for Alleged Deception in Acetaminophen Marketing

Texas Attorney General Ken Paxton has filed a lawsuit against Johnson & Johnson (J&J) and its spinoff company Kenvue, accusing the companies of deceptively marketing acetaminophen (Tylenol) and other acetaminophen products as safe for use during pregnancy while allegedly concealing evidence of risks to fetal development.1

The suit, filed in Panola County District Court on October 27, 2025, claims violations of the Texas Deceptive Trade Practices–Consumer Protection Act (DTPA) and the Texas Uniform Fraudulent Transfer Act (UFTA).2

Paxton’s office alleges that J&J and Kenvue “willfully ignored and attempted to silence the science” linking prenatal acetaminophen exposure to autism and attention-deficit/hyperactivity disorder (ADHD). The suit also claims the companies failed to warn consumers and fraudulently shifted liabilities from J&J to Kenvue to avoid responsibility for future litigation.

“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks,” Paxton said in a news release.1 “These corporations lied for decades, knowingly endangering millions to line their pockets. By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”

Peer-reviewed research has not established a causal link between acetaminophen and autism. | Image credit: Adriana – stock.adobe.com

What Are the Specific Allegations?

The state contends that J&J and Kenvue marketed acetaminophen as “the only safe painkiller for pregnant women,” despite evidence suggesting otherwise. The lawsuit references a 2021 consensus statement signed by more than 90 scientists calling for caution in the use of acetaminophen during pregnancy, though no government or medical organization has concluded that acetaminophen causes neurodevelopmental disorders.3

The lawsuit further alleges that J&J transferred acetaminophen-related liabilities to Kenvue—created in 2023 as a separate consumer health company—as part of an effort to “shield its ill-gotten assets from the families they harmed.”2 The state seeks civil penalties, injunctive relief, and asset disgorgement.

Does Acetaminophen Really Cause Autism?

While Paxton’s lawsuit cites numerous epidemiological studies claiming an association between prenatal acetaminophen exposure and ASD or ADHD, major health authorities and peer-reviewed research have found no causal link. A 2024 population-based sibling study published in JAMA found no association between acetaminophen use during pregnancy and risk of autism, ADHD, or intellectual disability when controlling for familial factors.4

“Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analyses,” the authors had concluded.“This suggests that associations observed in models without sibling control may have been attributable to confounding.”

Brian Lee, PhD, epidemiology professor at Drexel University, similarly explained to Johns Hopkins’ Public Health On Call podcast that earlier studies lacked rigorous genetic controls and likely reflected confounding factors such as maternal fever or infection.5 With the evidence available right now, he said, “the needle is pointing strongly toward there being no causal effect of acetaminophen use during pregnancy on autism.”

Recent Conversations Around Acetaminophen

The Texas lawsuit follows recent political attention to acetaminophen safety. In September, the Trump administration directed the FDA to initiate label updates noting a “potential association” between prenatal acetaminophen use and neurodevelopmental disorders—language that drew criticism from researchers for overstating uncertain evidence.4

Kenvue has rejected claims of causation, stating that it “continue[s] to believe there is no causal link between acetaminophen use during pregnancy and autism” and that patients should consult health care professionals before taking any over-the-counter medication, as is recommended during pregnancy.

Paxton’s action adds to his series of lawsuits against pharmaceutical manufacturers, including cases targeting Pfizer over COVID-19 vaccines and Eli Lilly over drug marketing practices.1 J&J previously agreed to a $700 million settlement with Texas over talc-related claims. The current case, Texas v Johnson & Johnson and Kenvue, seeks monetary penalties exceeding $250,000, restrictions on future marketing of acetaminophen to pregnant consumers, and an injunction against further deceptive practices.

Although Paxton’s office asserts that taking acetaminophen while pregnant “likely causes” autism and ADHD, the scientific community has not reached that conclusion. Most experts emphasize that available data remain observational and confounded, and that acetaminophen remains a recommended medication for managing pain and fever during pregnancy when used as directed.

References

1. Attor­ney Gen­er­al Pax­ton sues big phar­ma man­u­fac­tur­ers for decep­tive­ly mar­ket­ing Tylenol to preg­nant moth­ers despite known dan­gers to unborn children. Ken Paxton, Attorney General of Texas. October 28, 2025. Accessed October 28, 2025. https://www.texasattorneygeneral.gov/news/releases/attorney-general-paxton-sues-big-pharma-manufacturers-deceptively-marketing-tylenol-pregnant-mothers
2. Texas v Johnson & Johnson and Kenvue. Ken Paxton, Attorney General of Texas. October 28, 2025. Accessed October 28, 2025. https://www.texasattorneygeneral.gov/sites/default/files/images/press/Lawsuit.pdf
3. Bauer AZ, Swan SH, Kriebel D, et al. Paracetamol use during pregnancy - a call for precautionary action. Nat Rev Endocrinol. 2021;17(12):757-766. doi:10.1038/s41574-021-00553-7
4. McCormick B. Trump administration flags potential link between prenatal acetaminophen use, autism. AJMC®. September 22, 2025. Accessed October 28, 2025. http://ajmc.com/view/trump-administration-flags-potential-link-between-prenatal-acetaminophen-use-autism
5. Winny A. Understanding the evidence on pregnancy, Tylenol, and autism. Johns Hopkins Bloomberg School of Public Health. October 7, 2025. Accessed October 28, 2025. https://publichealth.jhu.edu/2025/the-evidence-on-tylenol-and-autism