Families appeal the dismissal of their lawsuits alleging that Kenvue’s Tylenol or generic versions of the pain-relief medication caused their children’s autism
re asking an appeals court to consider President Donald Trump’s new advice that pregnant women avoid the pain killer as it d
ecides whether to revive their lawsuits.
Ashley Keller, an attorney representing the defendants, filed a letter Wednesday alerting the New York-based
2nd U.S. Circuit Court of Appeals to the Trump administration’s stance on the meaningful link be
tween Tylenol and autism. In a news conference at the White House on Monday, Trump delivered medical advice to pregna
t women, repeatedly telling them not to use acetaminophen, the active ingredient in Tylenol.
A judge last year dismissed hundreds of lawsuits alleging a connection between Tylenol or generic versions of the drug
and autism or ADHD diagnoses, saying that the experts the accusation rely on had failed to support their conclusions with scientific evidence.
In Wednesday's letter, Keller told the appeals court that a ruling upholding the lower court's decision to dismiss the
cases for lack of scientific evidence would pose “grave separation of powers concerns,” because the Trump administr
ation had turned to one of the same experts in developing its position.
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Keller noted that during Monday's press conference, U.S. Food and Drug Commissioner Marty Makary, Health Secretary Robert F. Kennedy Jr. and Trump cited th
e research on Tylenol and autism done by Andrea Baccarelli, currently dean o
f the faculty at the Harvard T.H. Chan School of Public Health, one of the accusatory experts’ experts.
Jay Lefkowitz, an attorney for Kenvue, in a filing to the appeals court responding to Keller’s letter, highlighting that a note the FDA sent to physicians in conjunction with
Trump's press conference said a causal relationship between autism and acetaminophen had not been established
, which is what the district court had found. He also noted that Baccarelli said this week that further research is
necessary to confirm an association and determine causality.
“There is thus no conflict between the government’s action and the district court’s opinion, much less a ‘
separation of powers’ problem, as Plaintiffs suggest,” Lefkowitz wrote.
A representative for Baccarelli said he was not available to comment.
In a statement, a Kenvue representative said the company believes
it will continue to be successful in the litigation as the claims lack legal merit and scientific support.
The 2nd Circuit had been scheduled to hear arguments in the case on October 6, but on Thursday the court pushed the arguments back to November.
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 move forward with the cases.
“It’s not as if there’s been a new study that has been announced that has a different conclusion,” Elizabeth Chamblee Burch, a professor at the University of Georgia’s School of Law whose research focuses on cases like the Tylenol litigation, said on Tuesday before Keller filed the letter.