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Texas Attorney General Ken Paxton has initiated a lawsuit against Johnson & Johnson and Kenvue, the manufacturers of Tylenol, alleging that the companies deceptively marketed the pain reliever to pregnant women while knowing of a purported link to an increased risk of autism. The legal action, filed on Monday in the District Court of Panola County, Texas, seeks civil penalties and the cessation of marketing materials that assert Tylenol’s safety for pregnant women and children. Kenvue has vehemently denied the allegations, affirming the safety of its product and pledging to vigorously defend against the claims.
Allegations of Deceptive Marketing
The lawsuit claims that Johnson & Johnson and Kenvue violated the Texas Deceptive Trade Practices-Consumer Protection Act. According to the filing, the companies were aware that acetaminophen, Tylenol’s active ingredient, “is dangerous to unborn children and young children” but “hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women.” Paxton, a Republican who is also campaigning for the U.S. Senate, stated in a news release that “Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks.”
The legal challenge follows public comments made by President Donald Trump approximately a month prior, where he claimed a connection between Tylenol use during pregnancy and an increased risk of autism in children. This assertion was made despite existing medical evidence affirming the medication’s safety.
Lawsuit Demands and Company Responses
The Texas lawsuit has requested a jury trial and is seeking for the companies to “destroy any marketing or advertising materials in their possession that represent, directly or indirectly, that Tylenol is safe for pregnant women and children.” Additionally, the state is pursuing civil penalties of $10,000 per violation.
Kenvue issued a statement on Tuesday, emphasizing the company’s commitment to consumer health and safety. “We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children,” the company stated, adding that it would “vigorously defend ourselves against these claims” due to a belief that they “lack legal merit and scientific support.” Kenvue also encourages expectant mothers to consult their health professionals before taking any over-the-counter medication.
A spokesperson for Johnson & Johnson clarified that 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.”
Medical Community Perspective
Medical experts have consistently pointed out that autism has multiple causes, and the scientific evidence linking Tylenol to autism remains unsettled. Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), previously stated that “suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible.”
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Dr. Fleischman highlighted that acetaminophen is one of the limited options available for pregnant patients to manage pain and fever, conditions that can pose significant risks to both the pregnant individual and the fetus if left untreated. He concluded that “the conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”
