Texas Attorney General Ken Paxton has filed a lawsuit against Johnson & Johnson and Kenvue Inc., alleging that the companies misled consumers by "deceptively marketing Tylenol to pregnant mothers despite knowing that early exposure to acetaminophen, Tylenol’s only active ingredient, leads to a significantly increased risk of autism and other disorders."
The complaint claims that J&J "ignored and attempted to silence" research linking prenatal or early childhood exposure to acetaminophen with an increased risk of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD). It also accuses J&J of transferring assets and liabilities related to Tylenol to Kenvue in violation of the Texas Uniform Fraudulent Transfer Act, a move that Paxton’s office says was intended to avoid accountability. In a statement, Paxton wrote “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.”
Donald Trump suggested in September that Tylenol could be a cause of autism when used in pregnancy and the FDA initiated a label change for acetaminophen products to reflect the "risk". However, scientists and health associations worldwide have vigorously disputed the claims.
In response to the lawsuit, Kenvue Brands LLC has issued a statement reaffirming that consumer health and safety remain its top priority and expressed concern over what it described as “misinformation” regarding acetaminophen. The company maintains that acetaminophen remains the safest option for managing pain and fever during pregnancy, noting that untreated fever can itself pose risks to pregnant women and their unborn children.
Acetaminophen is one of the most extensively studied medications used in infants and children, with numerous randomized controlled trials supporting its safety when taken as directed. The company emphasized that independent research and reviews by global health authorities have found no proven link between acetaminophen use and autism.
Kenvue cited the FDA’s evaluated scientific evidence and concluded that available data do not support a causal connection between acetaminophen and autism, characterizing Paxton’s lawsuit as part of a broader agenda based on “a deliberate distortion of the facts” and adding that it would vigorously defend itself, asserting that the allegations “lack legal merit and scientific support.”
The World Health Organization also says that there is currently no conclusive scientific evidence linking prenatal acetaminophen use to autism. Autism affects approximately 62 million people worldwide (roughly one in 127) and its causes are believed to involve a combination of genetic and environmental factors.
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