Families in the United States who have been appealing the dismissal of their lawsuits alleging that Kenvue’s Tylenol or generic versions caused their children’s autism are asking an appeals court to consider the FDA’s new advice that pregnant women avoid the painkiller, as it decides whether to revive their lawsuits.
Reuters reports that Ashley Keller, an attorney representing the plaintiffs, filed a letter last week alerting the New York 2nd Circuit Court of Appeals to the Trump administration’s stance on the alleged link between Tylenol and autism.
Last year a judge had dismissed hundreds of lawsuits alleging a connection between Tylenol or generic versions of the drug and autism or ADHD diagnoses, saying the experts on whom the plaintiffs had relied had failed to support their conclusions with scientific evidence.
In last Wednesday’s letter, Keller told the appeals court that a ruling upholding the lower court’s decision would pose “grave separation of powers concerns”, because the Trump administration had turned to one of the same experts in developing its position.
Keller noted that during last Monday’s press conference, when the announcement was made and the warning issued on the apparent dangers of Tylenol, US Food and Drug Commissioner Marty Makary, Health Secretary Robert F Kennedy Jr, and Trump cited the research on Tylenol and autism done by Andrea Baccarelli, Dean of the faculty at the Harvard TH Chan School of Public Health, one of the plaintiffs’ experts.
In a statement, a Kenvue spokesperson noted that the FDA said a causal relationship has not been established between Tylenol and autism and that the company believes it will continue to be successful in the litigation as the claims lack legal merit and scientific support.
Last year, Manhattan Judge Denise Cote dismissed more than 500 lawsuits against Kenvue and retailers that sold store-brand acetaminophen, which alleged that the drugs caused autism spectrum disorder, or ADHD.
Cote had ruled the previous year that none of the expert witnesses offered by the plaintiffs to testify at trial that acetaminophen could cause the conditions had used a sound scientific methodology. She said the experts’ “unstructured approach” allowed “cherry-picking” and a “results-driven analysis”.
Product liability lawsuits, like the ones over acetaminophen, rely on experts to establish that a product is capable of causing the alleged harm.
The court is slated to hear arguments on 6 October in the plaintiffs’ appeal of Cote’s decision.
Legal experts have said it would be unusual if the appeals court gave the administration’s actions and Trump’s comments much weight in considering how to progress with the cases.
“It’s not as if there’s been a new study that has been announced that has a different conclusion,” said Professor Elizabeth Chamblee Burch, from the University of Georgia’s School of Law, whose research focuses on cases like the Tylenol litigation.
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