Texas Attorney General Ken Paxton announced a lawsuit Tuesday against Johnson & Johnson and Kenvue over disputed claims that Tylenol causes autism, alleging the companies deceptively marketed the painkiller to pregnant women while hiding potential risks.
The lawsuit, filed in Panola County District Court, follows President Donald Trump’s widely publicized September warning urging pregnant women to avoid acetaminophen, though many scientists dispute any causal link between the drug and neurological conditions.
According to the complaint, at least 26 epidemiological studies have linked prenatal acetaminophen exposure to autism spectrum disorder and attention-deficit hyperactivity disorder (ADHD). About 65% of pregnant women take the drug while pregnant, the lawsuit states.
Trump repeatedly urged Americans “don’t take Tylenol” during a September announcement on autism, prompting the FDA to acknowledge a “possible association” between the drug and autism when used during pregnancy.
Many scientists dispute the link. A large Swedish study of 2.5 million children found any association disappeared when comparing siblings exposed and unexposed to the drug during pregnancy, according to Nature. A February review of high-quality studies concluded prenatal acetaminophen exposure is “unlikely to confer a clinically important increased risk” of autism, Nature reported. Researchers say better-controlled studies account for confounding factors, such as maternal infections that prompted painkiller use.
Trump made the announcement alongside Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic whose anti-pharmaceutical stance has driven departures of career staffers at federal health agencies. Kennedy has promoted the effort under his “Make America Healthy Again” movement, which advocates for stricter food safety regulations and reduced pharmaceutical industry influence, though critics say it spreads medical misinformation.
Paxton’s lawsuit also alleges Johnson & Johnson fraudulently transferred Tylenol-related liabilities to spinoff company Kenvue to avoid billions in potential damages. Johnson & Johnson announced the consumer health spinoff in 2021, with parents filing scores of autism-related lawsuits starting in 2022 and Kenvue becoming independent in 2023. A federal judge dismissed hundreds of similar private lawsuits in December 2023, ruling the scientific evidence was unreliable.
Kenvue said it would vigorously defend against the lawsuit, calling the claims scientifically unfounded and an attempt to revive allegations already dismissed in federal court. The company said acetaminophen is the safest pain reliever for pregnant women and that rigorous research endorsed by medical professionals confirms no proven link to autism. Kenvue said the FDA has evaluated the evidence for over a decade and repeatedly concluded the data does not support a causal association.
In September, the FDA under the Trump administration announced it would require new warning labels reflecting a “possible association” between prenatal acetaminophen use and neurological conditions, while noting that “a causal relationship has not been established.” The FDA said untreated high fevers during pregnancy can also pose risks.
Texas is seeking civil penalties of $10,000 per violation.