Harvard Dean Cited in Trump Tylenol Warning Previously Served as Paid Expert Witness in 2023 Tylenol Suit
A Harvard public health dean connected acetaminophen to neurodevelopmental risks in pregnancy, a claim years after a judge criticized his testimony in a separate lawsuit against Tylenol’s maker.
A Harvard researcher whose analysis linked acetaminophen to neurodevelopmental disorders in utero is at the center of President Trump’s warning to pregnant women to avoid Tylenol. Dr. Andrea Baccarelli, dean of Harvard University’s T.H. Chan School of Public Health, co-authored a study analysis released last month that warned acetaminophen use during pregnancy could be associated with autism and other neurodevelopmental issues. The analysis, first reported by the Times of London, preceded a White House briefing in which federal health officials urged caution with the drug. The Trump administration has urged pregnant women to stop using Tylenol, and FDA Commissioner Dr. Marty Makary cited the review during Monday’s announcement, saying the “overwhelming body of evidence points to an association” between acetaminophen and autism. The president echoed the message in remarks from the Roosevelt Room, saying, “With Tylenol, don’t take it! Don’t take it.”
Harvard confirmed to the Times that Baccarelli was a paid expert witness in a 2023 class-action suit against Tylenol maker Kenvue, brought by a group of parents who alleged their children’s ADHD and autism resulted from maternal use of the drug during pregnancy. He was one of five expert witnesses for the plaintiffs in the case, all of whom had their testimonies dismissed by a federal judge who deemed their conclusions “unbalanced.” U.S. District Judge Denise Cote wrote that, in his reports, “the discussion is incomplete, unbalanced and at times misleading,” and that the witnesses “downplay[ed] studies that undercut his causation thesis.” Harvard would not disclose compensation details for Baccarelli’s involvement. In a statement shared with the White House ahead of Monday’s press conference, Baccarelli defended his NIH-funded review and urged cautious interpretation of the evidence, while reiterating that patients who need fever or pain reduction during pregnancy should use the lowest effective dose for the shortest duration after consulting with their physician about individual risk-benefit calculations.
Other studies have suggested a link between prenatal acetaminophen exposure and autism, but the scientific community widely acknowledges uncertainties and methodological concerns. The Coalition for Autism Scientists, which includes more than 250 American researchers, told outlets that the administration’s warnings do not establish causation and can mislead the public into believing a simple cause-and-effect relationship exists. Researchers emphasize the need for more rigorous, prospective studies before drawing definitive conclusions about Tylenol and neurodevelopmental outcomes. The Times of London had reported on the analysis last month, and Harvard’s confirmation of Baccarelli’s role as an expert witness underscores that the executive push behind the warnings intersects with ongoing debates over the strength of the underlying evidence.
As officials at the White House and FDA continue to frame the issue as a precautionary public-health stance, critics caution against conflating correlation with causation. They note that acetaminophen is commonly used for fever and pain management during pregnancy and that a broader consensus on safety requires robust, replicable research. The White House has indicated that the guidance is not a blanket ban on Tylenol, but a call to limit exposure and consult with clinicians about risk versus benefit. The evolving discussion reflects broader tensions in public health messaging when research yields associations that remain contested within the scientific community.
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Close to the timeline, officials stressed that recommendations are intended to minimize potential risk while recognizing the drug’s availability for legitimate medical use. Critics argue that public-health messages should avoid overstating links and should emphasize individualized medical guidance. The administration’s statements come amid a broader national dialogue on how to communicate evolving science to expectant parents while avoiding unnecessary alarm. The Health topic label reflects ongoing attention to maternal and child health risks, as researchers weigh the balance between urgent public warnings and the strength of causal inferences in acetaminophen studies.
