(CNN) — Texas Attorney General Ken Paxton has filed a lawsuit against the companies Johnson & Johnson and Kenvue, claiming that they “deceptively” marketed Tylenol to pregnant mothers and that the medication is tied to an increased risk of autism. Kenvue said in a statement that the medication is safe and the company will “vigorously defend” against the claims.
The lawsuit, dated Monday and filed in the District Court of Panola County, Texas, comes about a month after President Donald Trump publicly claimed that the use of Tylenol during pregnancy can be associated with an increased risk of autism in the child, despite decades of evidence that the medication is safe.
“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,” Paxton, the state’s Republican attorney general, who is also running for US Senate, said in a news release Tuesday. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
The lawsuit claims that Johnson & Johnson and Kenvue violated the Texas Deceptive Trade Practices-Consumer Protection Act because they knew that acetaminophen, the active ingredient in Tylenol, “is dangerous to unborn children and young children” and “they hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women,” according to the lawsuit.
The state’s lawsuit has requested a jury trial and, in part, calls 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.” The lawsuit also calls for the companies to pay civil penalties to the state in the amount of $10,000 per violation.
“Nothing is more important to us than the health and safety of the people who use our products. 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,” Kenvue said in an emailed statement Tuesday.
“We will vigorously defend ourselves against these 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,” the statement said in part. “We also encourage expecting mothers to speak to their health professional before taking any over-the-counter medication, including acetaminophen, as indicated on our product label for Tylenol®.”
In a statement, a Johnson & Johnson company spokesperson said it “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.”
Experts have said there are multiple causes of autism, and the science showing a connection between autism and Tylenol is not settled.
“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,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement in September.
“Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it,” he said. “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.”