Texas Attorney General Ken Paxton has filed a lawsuit against Johnson & Johnson and its spinoff company Kenvue, accusing them of “deceptively marketing” Tylenol to pregnant women despite allegedly knowing about potential risks to fetal neurological development.
The lawsuit, filed in state court, claims that the companies were aware of studies suggesting links between acetaminophen—the active ingredient in Tylenol—and developmental disorders such as autism and ADHD, but continued to promote the drug as safe for use during pregnancy.
Paxton’s lawsuit follows recent federal guidance issued under the Trump administration in September, which recommended that pregnant women avoid acetaminophen due to possible connections between prenatal exposure and neurological disorders. The White House cited three studies that reportedly found correlations between acetaminophen use during pregnancy and higher rates of autism and ADHD in children.
“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks,” Paxton said in a statement. “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.”
The complaint also accuses Johnson & Johnson of attempting to shield itself from liability by transferring assets and responsibilities to Kenvue, in alleged violation of the Texas Uniform Fraudulent Transfer Act. The attorney general’s office claims the move was designed to protect Johnson & Johnson’s finances ahead of expected litigation.
“Despite being well aware of this fact, Tylenol was marketed as a completely safe pain medication for pregnant women,” the lawsuit states. “This deceptive marketing violates Texas consumer protection laws.”
In response, Tylenol and its parent companies have strongly denied any wrongdoing and rejected the scientific claims underpinning Paxton’s lawsuit.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” Tylenol said in a statement. “We strongly disagree with any suggestion otherwise and are deeply concerned about the confusion and unnecessary fear this may cause among expecting mothers.”
Medical experts remain divided on the issue. While several recent studies have suggested possible correlations between prenatal acetaminophen exposure and neurodevelopmental issues, other researchers argue the data are inconclusive and confounded by other factors, such as maternal illness or genetics.
A 2024 study published in JAMA found that when researchers compared sibling pairs—one exposed to acetaminophen in utero and one not—the apparent link between acetaminophen use and autism or ADHD disappeared, suggesting that shared familial or environmental factors, not the drug itself, might explain earlier findings.
The Texas case marks the first state-level lawsuit filed against Tylenol manufacturers following the Trump administration’s updated guidance. Legal experts say the case could set a precedent for similar actions in other states, depending on how courts interpret the evolving scientific evidence and the companies’ marketing practices.
For now, the U.S. Food and Drug Administration has not changed its formal labeling requirements for acetaminophen, which remains one of the most commonly used pain relievers in the world. However, the new political and legal attention on the drug is likely to reignite public debate about medication safety during pregnancy—and the balance between scientific uncertainty and consumer protection.
