Texas AG Sues Tylenol Over Discredited Autism and ADHD Claims

Texas Attorney General Files Lawsuit Against Tylenol Manufacturer

Texas Attorney General Ken Paxton has filed a lawsuit against the manufacturer of Tylenol, citing controversial and debunked claims by Health and Human Services Secretary Robert F. Kennedy Jr. that acetaminophen, the drug’s active ingredient, causes “a significantly increased risk of autism and other disorders.” These claims have been widely criticized by medical professionals and scientists.

Kennedy, who lacks science or medical degrees, has a history of promoting conspiracy theories and unfounded claims about vaccines and autism. This includes referencing discredited research by Andrew Wakefield, who lost his medical license for fraud and “serious professional misconduct.” In September, Kennedy held a press conference with former President Donald Trump, where they made multiple false or unproven claims about a link between autism and acetaminophen, as well as other factors. Trump has repeatedly claimed that pregnant women and children should avoid Tylenol “for virtually any reason.”

Medical Community Condemns Claims as Erroneous and Dangerous

Numerous doctors, scientists, and medical organizations have condemned these claims as “completely erroneous and dangerous,” with no supporting evidence. This includes Fox News senior medical analyst Dr. Marc Siegel, MSNBC medical analyst Dr. Vin Gupta, and Republican Senator and licensed medical doctor Sen. Bill Cassidy (R-LA). Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), criticized Kennedy’s press conference for presenting “irresponsible” claims that were “not backed by the full body of scientific evidence.”

Fleischman emphasized that over two decades of research on acetaminophen use during pregnancy has not found any reputable studies concluding that it causes neurodevelopmental disorders in children. He highlighted that the two highest-quality studies on this subject — including one published in JAMA in April 2024 — found no significant associations between acetaminophen use during pregnancy and children's risk of autism, ADHD, or intellectual disability.

The Lawsuit and Its Foundation

Paxton’s lawsuit is based on Kennedy’s false, unfounded, and misleading claims. Filed in Panola County, a conservative area in rural east Texas, the complaint names Johnson & Johnson, Kenvue, Inc., and Kenvue Brands LLC as defendants. Paxton accuses them of “willfully ignoring and attempting to silence the science” regarding the potential risks of acetaminophen and failing to include warning labels on their products.

The complaint argues that autism is more prevalent in the U.S. than globally, and that diagnoses of ASD and ADHD have increased over time. However, critics note that this increase is largely due to expanded diagnostic criteria and better access to healthcare in the U.S. Additionally, the widespread use of acetaminophen since the late 19th century contradicts claims that it could be causing a recent spike in autism cases.

Risks of Untreated Fevers and Pain

Other studies, not mentioned in the lawsuit, show a link between fevers during pregnancy and ASD. Forgoing treatment for pain and fever during pregnancy poses serious health risks for both mother and child. Dr. Fleischman warned against the dangers of Kennedy’s claims, noting that acetaminophen is essential for managing maternal fevers and headaches, which are early signs of preeclampsia.

Pre-eclampsia and other hypertensive crises during pregnancy are leading causes of maternal death, with complications like strokes, organ damage, and preterm labor. Children born to mothers with pre-eclampsia face higher risks of various health issues, including diabetes, coronary artery disease, and psychiatric illnesses.

Expert Opinions and Scientific Consensus

Dr. Peter Hotez, a pediatrician and researcher at the Texas Medical Center, has long criticized the claims by Kennedy and other anti-vaccine activists about the causes of autism. He pointed to studies showing that autism is linked to more than 100 known genes, with only a few environmental exposures, such as the anti-seizure medication valproate, having strong evidence of contributing to autism. Hotez noted that the evidence for acetaminophen is not strong and cited the Swedish study finding no significant associations.

Hotez also mentioned some studies suggesting a protective effect of acetaminophen, though these were not highlighted in Kennedy’s press conference. He called for more organized research into environmental exposures interacting with autism genes but noted that Tylenol is not currently a priority for autism scientists.

Legal Challenges and Expert Testimony

Paxton partnered with Ashley Keller, a personal injury lawyer whose expert witnesses were previously excluded in similar lawsuits. Keller is representing plaintiffs in personal injury lawsuits claiming prenatal Tylenol use caused neurodevelopmental harms. However, in December 2023, Judge Denise L. Cote excluded all five expert witnesses submitted by the plaintiffs, finding their methodologies unreliable.

Cote criticized the plaintiffs’ experts for cherry-picking data, misrepresenting study results, and ignoring genetic factors. She ruled that the plaintiffs lacked admissible evidence to support their claims. Keller has appealed the rulings to the U.S. Court of Appeals for the Second Circuit.

Johnson & Johnson and Kenvue maintain that credible scientific data shows no proven link between acetaminophen and autism. The Tylenol website advises consumers to consult healthcare professionals before using the drug during pregnancy or for children.