Texas Sues Tylenol Makers Over Claims of Links to Autism

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Texas Attorney General Ken Paxton is suing the pharmaceutical companies behind Tylenol for “deceptively marketing” the drug as a safe option for pregnant women.

The lawsuit against Johnson & Johnson and Kenvue, filed by Paxton on Tuesday, claimed the companies knew that being exposed to acetaminophen, the active ingredient in Tylenol, before birth or during early childhood led to an increased risk of autism and other health problems, but they hid that information from consumers.

President Donald Trump claimed that Tylenol use during pregnancy increases a child’s risk of autism in a September announcement, after Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. promised earlier this year to find what “caused the autism epidemic.”

However, prominent obstetrics experts and medical associations have largely disputed the claimed link and the quality of the studies cited by the Trump administration in developing it.

“Suggestions that acetaminophen use during pregnancy causes autism are not only very concerning to clinicians, but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need this beneficial medication during pregnancy,” said Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), in September. “In more than two decades of research on acetaminophen use during pregnancy, no reputable study has successfully concluded that acetaminophen use during any trimester of pregnancy causes neurodevelopmental disorders in children.”

Learn more: Trump links Tylenol use during pregnancy to autism. What does science show?

Paxton, however, highlighted the Trump administration’s claims in the lawsuit filed in his state, saying drug companies had long had access to evidence cited by the administration but refused to take action.

“These companies have lied for decades, knowingly putting millions of people at risk to line their pockets,” Paxton said in a press release. “By holding big pharmaceutical companies accountable for poisoning our population, we will help make America healthy again.” »

The Texas lawsuit is the first filed by the state government against pharmaceutical companies over the alleged link between Tylenol and autism. But hundreds of families with children with autism or attention deficit hyperactivity disorder (ADHD) have filed lawsuits over similar complaints.

Kenvue, which spun off from Johnson & Johnson in 2023 and has sold Tylenol ever since, has repeatedly defended the drug’s safety and denied allegations that it misled customers. “Nothing is more important to us than the health and safety of the people who use our products. We are deeply concerned about the perpetuation of misinformation about the safety of acetaminophen and the potential impact it could have on the health of American women and children,” the company said in response to the lawsuit. “We stand strongly with the global medical community in recognizing the safety of acetaminophen and believe we will continue to prevail in litigation as these claims lack legal merit and scientific support. »

Johnson & Johnson told several media outlets in a statement that it “divest its consumer health business years ago, and all rights and responsibilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), belong to Kenvue.” TIME has contacted Johnson & Johnson for comment.

A federal judge in New York dismissed some lawsuits earlier this year due to a lack of reliable scientific evidence. The plaintiffs are appealing the decision. Many other cases are still being processed by the courts.

In addition to allegations that the companies hid the risks of taking acetaminophen, Paxton’s lawsuit also alleges that Johnson & Johnson sought to avoid responsibility for its actions by divesting itself from Kenvue. Before the spinoff, Johnson & Johnson sold Tylenol for more than six decades.

The legal challenge is one of several filed by the Texas Attorney General against pharmaceutical and healthcare companies.

Paxton, a candidate for U.S. Senate, has previously filed lawsuits against Eli Lilly — alleging the company bribed medical providers to prescribe GLP-1 and other drugs it makes — and Pfizer. Paxton filed an appeal in the latter lawsuit, in which he claimed the company illegally misrepresented the effectiveness of its COVID-19 vaccine, after a district court threw out the case. Pfizer previously said the lawsuit was without merit and that the company’s “statements made about its COVID-19 vaccine were accurate and based on science.” An Eli Lilly spokesperson said in August that the company intended to “vigorously defend” the lawsuit, pointing to previous court rulings that found similar accusations lacked merit.

The Texas attorney general and top prosecutors in many other states have won a $700 million settlement against Johnson & Johnson in a lawsuit accusing the company of making misleading claims about its talc-based baby powder.

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