
Texas Attorney General Ken Paxton sued the pharmaceutical giant Johnson & Johnson and its affiliates Tuesday over accusations that the drug Tylenol may cause autism in pre-born infants during pregnancy.
Kenvue, a spinoff of Johnson & Johnson, was formerly its consumer healthcare division and has been selling the drug since 2023.
In the first lawsuit of its kind from a state government, the Texas AG alleged on Oct 28 that Johnson & Johnson knowingly failed to warn mothers about the risk of taking Tylenol while pregnant, reported the Texas Tribune.
The lawsuit comes after President Donald Trump and U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. announced in September that pregnant women should not take Tylenol, labeling it a possible cause of autism in children.
The U.S. Food and Drug Administration has plans to include a warning on the Tylenol label about the connection to neurodevelopmental disorder, which Kenvue opposes in court.
This is not the first time at that Texas has sued Johnson & Johnson.
In 2012, the firm agreed to a settlement with then-Attorney General Greg Abbott for $158 million for deceptive marketing of Risperdal, which is used to treat schizophrenia.
Texas also negotiated a $290 million settlement in 2021 regarding the company’s involvement in the opioid epidemic and received a $8.88 million payout in 2019 as part of a multi-state lawsuit due to the failure to disclose serious health risks and fraudulent marketing of one od its medical devices.
Kenvue said in a statement that it would strongly defend itself against the accusations in court.
“We will defend ourselves against these baseless claims and will respond per the legal process,” Melissa Witt, a spokeswoman for Kenvue, told the New York Times.
“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,” said Witt..
Clare Boyle, a spokeswoman for Johnson & Johnson, told the New York Times that they had “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.”
Paxton’s lawsuit accuses both Johnson & Johnson and Kenvue deliberately withholding evidence from consumers about Tylenol’s connection to autism and attention deficit hyperactivity disorder, also known as ADHD.
The AG further claimed that Kenvue was created only to protect Johnson & Johnson from liability over the various lawsuits regarding Tylenol.
The scientific connection between Tylenol and autism is still hotly disputed.
The Trump administration and the Texas AG’s office have pointed to an August review conducted by epidemiologists at Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai.
The review found that over half of the 46 studies included in the review found a evidence of a positive link between Tylenol use during pregnancy and childhood autism and ADHD.
More than half of the 46 studies included in the review found a positive correlation between use of the drug during pregnancy and neurodevelopmental disorders in children.
However, several major medical associations have called these claims overly generalized and potentially harmful and say that the studies fail to prove that Tylenol causes autism, which they say is due to genetics and environmental factors.
Autism affects approximately one in 31 American children. It has increased almost 300% over the past two decades, partially due to better screening and an expanded definition of those who fall under the diagnosis.
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