Texas AG Paxton Sues Tylenol Manufacturer For Not Disclosing Associated Risks Of Autism

Texas Attorney General Ken Paxton has sued ​​Johnson & Johnson and Kenvue for deceptive marketing practices and not informing the public about the potential harms of Tylenol for unborn and young children. “The reckoning has arrived,” Paxton wrote in the lawsuit brief. The AG also accused Johnson and Johnson of violating the Texas Uniform Fraudulent Transfer Act by fraudulently transferring Tylenol to Kenvue as a way to protect assets against future liabilities for harms caused by the product.

The lawsuit comes just a month after HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced the initial results of the administration’s investigation into the environmental triggers that are contributing to the autism spectrum disorder (ASD) epidemic. Dr. Makary referenced the results of a study with researchers from Yale, Columbia, and Harvard that found acetaminophen, the primary active ingredient in Tylenol, is associated with neurodevelopmental disorders like ASD.

“Last month, the federal government confirmed what Defendants knew for years: acetaminophen use during pregnancy likely causes conditions like ASD and ADHD,” Paxton wrote in the lawsuit. “Given how widely acetaminophen is used and how prevalent these conditions are, Defendants face tens of billions of dollars in damages to permanently injured children. Because of their fraudulent transfer, there may be insufficient funds to compensate Texas victims.”

Paxton said the pharma companies “willfully ignored the science” for decades and stated there are at least 26 epidemiological studies that show a positive association between prenatal exposure to acetaminophen and ASD and ADHD. In addition, Paxton said six studies show a dose-response relationship between prenatal exposure to acetaminophen and ADHD, while two studies show a relationship between prenatal exposure and ASD.

Ninety-one scientists signed a consensus statement in September 2021 declaring “the combined weight of animal and human scientific evidence is strong enough for pregnant women to be cautioned by health professionals against [acetaminophen’s] indiscriminate use, both as a single ingredient and in combination with other medications.” The scientists made this statement in response to dozens of studies showing increased risks of ASD, language delays, decreased IQ, cerebral palsy, and other neurodevelopmental conditions.

The lawsuit accuses the defendants of ignoring the scientific evidence and failing to update the warning labels to give pregnant women informed consent. In addition to failing their “duty” to update the warning label, Paxton said the defendants “practically encourage women to disregard the warnings” of Secretary Kennedy and Commissioner Makary.

The Tylenol webpage responds to the claims that the product is associated with an increased risk of autism for children exposed prenatally. It states, “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents.”

The company further states that acetaminophen is the “safest pain reliever option for pregnant women” and “Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”

While Paxton references 26 studies showing a positive association between acetaminophen exposure in utero with ASD, Tylenol references “decades of rigorous research” by stating, “There have been eight studies looking at the relationship between in utero exposure and autism diagnosis.”

Tylenol falsely states that three of these studies (Okubo 2025, Ahlqvist 2024, Janecka 2018), which it says are “the most methodologically robust, show no evidence of an association.” The Okubo study states that the propensity score (PS) matching analysis “indicated small increases in risk.” The Ahlqvist study states, “models without sibling controls identified marginally increased risks of autism and attention-deficit/hyperactivity disorder (ADHD) associated with acetaminophen use during pregnancy.” The Janecka study did conclude there isn’t a positive association between acetaminophen and ASD, but the authors note the study is “exploratory in nature” and the “generalizability of our findings remains to be verified.”

The New York Times quoted Molly Meegan, general counsel of the American College of Obstetricians and Gynecologists (ACOG), who said Paxton is misrepresenting the science. “The most robust studies of the last two decades have continued to demonstrate that acetaminophen does not cause autism — and that it can play a medically important role in the care ob-gyns provide to their pregnant patients,” Meegan said. Johnson & Johnson and Moderna were ACOG’s largest two donors in 2024-2025, with a contribution of $100,000 to $250,000.

Clare Boyle, a spokesperson for Johnson & Johnson, did not directly respond to the claims that the company violated the Texas Uniform Fraudulent Transfer Act, but denied the claim that the company has any liability associated with its former product, Tylenol. She said 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.”

The lawsuit explains that Johnson & Johnson began “peeling off” consumer health products from its portfolio, including Tylenol, in November 2021, which was shortly before dozens of lawsuits were filed against acetaminophen sellers alleging neurodevelopmental harms. On May 8, 2023, the company still had 89.6% of the total shares of Kenvue as it announced it would “dispose” of its majority stake in Kenvue by the end of the year.

Paxton alleges that Johnson & Johnson knew about the risk of potential lawsuits related to Tylenol and intentionally moved the product to a subsidiary to protect the “deep pockets” and assets of the primary company.

AG Paxton has filed multiple lawsuits against pharmaceutical manufacturers over the past few years, including Pfizer and Eli Lilly, for alleged Medicaid fraud.