Texas Attorney General Ken Paxton has launched a high-profile legal battle against Johnson & Johnson and its spinoff, Kenvue, alleging that the companies deceptively marketed Tylenol to pregnant women while downplaying or concealing potential risks to children’s brain development. The lawsuit, filed on October 28, 2025, is the first by a state government to seize on President Donald Trump’s recent claims that Tylenol use during pregnancy could increase the risk of autism or other neurodevelopmental disorders—an assertion that remains unproven and is widely disputed by medical authorities.
Paxton’s complaint, filed in a Texas state court, alleges that Johnson & Johnson and Kenvue knowingly withheld evidence from consumers about possible links between Tylenol’s active ingredient, acetaminophen, and conditions such as autism and attention deficit hyperactivity disorder (ADHD). He further claims that Johnson & Johnson spun off Kenvue in 2023 to shield itself from liability related to Tylenol litigation. According to ABC News, Paxton declared, “Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. 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.”
This legal action comes on the heels of President Trump’s September 2025 statements linking Tylenol use during pregnancy to autism, which were repeated on his Truth Social platform as recently as the weekend before the lawsuit was filed. “Pregnant Women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY,” Trump wrote, further fueling public debate. Despite the attention, major medical organizations and regulatory agencies have consistently stated that there is no proven causal link between acetaminophen and autism or ADHD.
Johnson & Johnson, which sold Tylenol for decades before spinning off its consumer health division as Kenvue, responded to the lawsuit by emphasizing that all rights and liabilities associated with Tylenol now rest with Kenvue. "Johnson & Johnson 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," a spokesperson told Axios. Kenvue, for its part, has pushed back forcefully against the allegations. In a statement provided to ABC News, the company said, “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.” The company added, “We will defend ourselves against these baseless claims and respond per the legal process. We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support.”
Paxton’s lawsuit is not the first legal challenge faced by Tylenol’s manufacturers regarding autism and ADHD risks. Since 2022, hundreds of lawsuits have been filed by parents of children diagnosed with these conditions, alleging that the companies failed to provide sufficient warnings about the potential dangers of acetaminophen use during pregnancy. Plaintiffs have engaged researchers from Harvard, the University of Southern California, and other institutions to present evidence of a causal link. However, a federal judge in New York dismissed the main group of cases in 2023, ruling that the expert testimony presented was not conclusive. That decision is now under appeal, with a hearing scheduled for November 2025.
The scientific evidence on this issue remains mixed. According to The New York Times, a recent meta-analysis led by researchers at Mt. Sinai, Harvard, UCLA, and UMass Lowell found that prenatal exposure to acetaminophen may be associated with an increased risk of neurodevelopmental disorders, including autism and ADHD. However, the study’s authors cautioned that their work does not prove causation and did not recommend that pregnant patients stop using Tylenol. More than half of the 46 studies reviewed found a positive correlation, but the studies themselves are subject to confounding factors, such as genetics and other environmental influences.
Major medical organizations have consistently maintained that acetaminophen is safe for use during pregnancy when taken as directed. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), reiterated this stance in a statement on October 28, 2025: “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy.” Molly Meegan, general counsel for ACOG, added, “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.”
Notably, an April 2024 study funded by the National Institutes of Health and published in JAMA found no link between acetaminophen use during pregnancy and increased risk of autism, ADHD, or intellectual disability in children. Other large-scale studies, including one involving nearly 2.5 million children born in Sweden, have found no association between acetaminophen use and neurodevelopmental disorders when accounting for maternal genetics.
Despite the lack of conclusive evidence, the Food and Drug Administration announced in September 2025 that it was considering adding a warning to Tylenol labels about potential risks of neurodevelopmental disorders. Kenvue has stated it will oppose any such changes, arguing that the science does not support the move.
The lawsuit also alleges that Johnson & Johnson’s decision to spin off Kenvue was motivated, at least in part, by a desire to shield itself from liability related to Tylenol litigation—a claim the company denies. Wall Street analysts, as reported by The New York Times, have suggested that the spinoff was primarily driven by Johnson & Johnson’s desire to focus on its more profitable pharmaceutical and medical device businesses, especially in light of other costly lawsuits related to opioids and talc-based baby powder.
Paxton’s legal strategy includes enlisting the help of Ashley Keller from the Chicago firm Keller Postman, which also represents plaintiffs in the ongoing personal injury cases. The Texas attorney general, who is currently challenging longtime Senator John Cornyn in a heated Republican primary, has a track record of filing lawsuits that align with Trump’s priorities—sometimes in conservative jurisdictions thought to be more sympathetic to such claims.
Political observers note that Paxton’s lawsuit could have ramifications beyond the courtroom, potentially energizing certain segments of the Republican base ahead of the 2026 primary. Louisiana Senator Bill Cassidy, a physician and chair of the Health, Education, Labor, and Pensions Committee, criticized the Texas suit, telling ABC News, “I'm a doctor, so I'm always going to go where the medical science lands and the best evidence is there's no relationship.” Cassidy argued that the lawsuit should be dismissed due to weak evidence.
As the legal, scientific, and political debates swirl, one thing remains clear: the safety of acetaminophen during pregnancy continues to be a matter of public concern, even as leading medical authorities insist that the medication remains the safest option for pregnant women in need of pain relief. The upcoming appeal hearings and possible regulatory changes will be closely watched by families, physicians, and policymakers alike.
With the science still unsettled and the courts yet to rule definitively, the controversy over Tylenol, autism, and corporate responsibility is far from over.
