Tylenol
NEW YORK – The makers of Tylenol and other acetaminophen products won’t get a second chance to convince a federal appeals court that lawsuits claiming they can cause autism should be thrown out of court.
A three-judge panel of the U.S. Court of Appeals for the Second Circuit reinstated previously disqualified experts who claim a link between prenatal use and autism and ADHD. Companies like Kenvue, CVS, Walmart and Rite Aid had asked for a rehearing before the entire Second Circuit, but that request was denied Oct. 16.
An appeal to the U.S. Supreme Court is the next step for the defendants as they fight to end more than 500 lawsuits.
District judge Denise Cote had agreed with the companies, dooming claims supported by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a former plaintiffs lawyer. He has provided valuable support to his former colleagues’ litigation efforts, including issuing reports describing possible associations between Tylenol and autism, issuing public health warnings to pregnant women and calling for retraction of a prominent medical journal article finding no such link. The FDA is currently investigating the supposed link.
Judge Cote seemingly halted federal multidistrict litigation in 2023 when she excluded opinions by Dr. Andrea Baccarelli, the dean of Harvard’s T.H. Chan School of Public Health who was quoted in a press release issued by the Trump White House when it announced plans to link Tylenol to autism, and four other experts who testified that Tylenol and other acetaminophen painkillers can cause autism and ADHD in unborn children.
Dr. Baccarelli relied upon a method known as Bradford Hill analysis, which weighs multiple factors including biological plausibility and dose and duration of exposure to decide whether a statistical correlation reflects actual causation.
After examining Dr. Baccarelli and other experts’ opinions, Judge Cote concluded “their analyses have not served to enlighten but to obfuscate the weakness of the evidence on which they purport to rely and the contradictions in the research.”
The ruling was a blow to many high-profile plaintiff firms. Leading the case are Ashley Keller of Keller Postman, Mikal Watts of Watts Guerra and Mark Lanier of The Lanier Law Firm.
But the Second Circuit on July 13 disagreed with Cote, with Judge Guido Calabresi writing that the debate has “become political.”
“But the issue before us is not political,” he wrote. “It is not about positions taken by elected officials or political appointees.”
He agreed Judge Cote was within her authority to exclude two experts, but reversed her exclusion of Drs. Baccarelli, Eric Hollander and Brandon Pearson. Their inclusion would have “profound public health implications,” PhRMA wrote in an amicus brief urging rehearing, citing the findings of several groups who have failed to find a link.
“Currently, pregnant women turn to acetaminophen to safely treat illness and fever, which if left untreated, can damage the health of the growing fetus,” it adds.
“Eschewing juridical gatekeeping and leaving it to juries to decide the scientific question risks undermining doctors’ and expectant mothers’ justified confidence in this important medicine.”
