Kenvue and several major pharmacy and retail chains have asked the 2nd Circuit U.S. Court of Appeals to reconsider its July ruling that reinstated roughly 550 lawsuits alleging prenatal acetaminophen use contributed to autism spectrum disorder or ADHD in children, according to a filing submitted Sept. 11.
The 2nd Circuit ruling in July overturned parts of U.S. District Judge Denise Cote’s earlier decision to exclude testimony from several plaintiffs’ experts on general causation, the threshold question of whether prenatal acetaminophen exposure is capable of causing autism or ADHD. Without that expert testimony, Ms. Cote had granted summary judgment for the defendants. The appeals panel restored 3 of 5 excluded experts, finding their methodologies were accepted within their fields, while upholding the exclusion of two others.
Defendants in the rehearing request include Kenvue, Walgreens, CVS, Walmart, Target, Costco, Kroger and Albertsons. They argue the panel’s decision undercuts the gatekeeping role federal judges play in screening expert testimony and are asking the court to either reverse the ruling or clarify that the reinstated experts’ opinions still require further review by Ms. Cote before trial.
The 2nd Circuit was explicit that its ruling did not address whether acetaminophen actually causes autism or ADHD or whether Kenvue was required to provide additional warnings. The FDA has said a causal relationship between acetaminophen use during pregnancy and autism or ADHD has not been established. The American College of Obstetricians and Gynecologists has said the current weight of evidence does not support a causal link.
The rehearing request comes amid broader Tylenol-related litigation against Kenvue, including lawsuits from Texas Attorney General Ken Paxton accusing the company of deceptively marketing Tylenol to pregnant women, and comments from President Donald Trump urging pregnant women to limit acetaminophen use.
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