Texas Attorney General Ken Paxton has filed a lawsuit against the pharmaceutical companies producing Tylenol, accusing them of “deceptively marketing” the drug as a secure choice for expectant mothers.
The legal action against Johnson & Johnson and Kenvue, initiated by Paxton on Tuesday, asserts that the companies were aware of an elevated risk of autism and other health issues linked to acetaminophen exposure (Tylenol’s active ingredient) prenatally or in early childhood, yet concealed this knowledge from consumers.
In September, President Donald Trump alleged a link between Tylenol use during pregnancy and an increased risk of childhood autism. This followed an earlier call by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. to identify the causes of the “autism epidemic.”
However, prominent obstetrics and medical organizations have disputed this asserted connection and questioned the reliability of the studies referenced by the Trump Administration to support it.
“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,” Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), stated in September. “In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children.”
Nevertheless, Paxton referenced the Trump Administration’s assertions in Texas’s lawsuit, contending that the pharmaceutical firms had long possessed the evidence cited by the Administration yet failed to act upon it.
“These corporations lied for decades, knowingly endangering millions to line their pockets,” Paxton declared in a press release. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
This Texas lawsuit represents the inaugural legal action initiated by a state government against these pharmaceutical companies regarding the purported connection between Tylenol and autism. However, hundreds of families with children diagnosed with autism or attention-deficit hyperactivity disorder (ADHD) have also brought forth similar legal claims.
Kenvue, which was established as a spin-off from Johnson & Johnson in 2023 and has been responsible for Tylenol sales since then, has consistently affirmed the drug’s safety and refuted accusations of deceiving consumers. In response to the lawsuit, the company stated, “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.” It added, “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.”
Johnson & Johnson informed multiple news outlets in a statement that 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.” TIME has sought a statement from Johnson & Johnson.
A federal judge in New York dismissed several of the lawsuits, citing insufficient reliable scientific evidence. The plaintiffs are currently appealing this ruling, while many other cases continue to progress through the judicial system.
Beyond claiming that the companies concealed the risks associated with acetaminophen, Paxton’s lawsuit further contends that Johnson & Johnson attempted to avoid accountability for its conduct by spinning off Kenvue. Before this divestiture, Johnson & Johnson had marketed Tylenol for over sixty years.
This legal challenge is among several initiated by the Texas Attorney General targeting health and pharmaceutical corporations.
Paxton, who is campaigning for the U.S. Senate, has previously brought lawsuits against Eli Lilly—accusing the company of bribing medical professionals to prescribe GLP-1 and other medications it produces—and Pfizer. Paxton lost the latter lawsuit, where he alleged Pfizer unlawfully misrepresented its COVID-19 vaccine’s effectiveness, after a district court dismissed the case. Pfizer had previously asserted the lawsuit was baseless and that its “representations made by the company about its COVID-19 vaccine have been accurate and science-based.” In August, an Eli Lilly spokesperson indicated the company plans to “vigorously defend against” the lawsuit, highlighting prior court decisions that deemed similar accusations unfounded.
The Texas Attorney General, along with chief prosecutors from numerous other states, previously sued Johnson & Johnson in a lawsuit alleging the company made deceptive statements about its talc-based baby powder.