Health and Human Services Secretary Robert F. Kennedy Jr. is among those claiming products like Tylenol can cause autism when taken by expecting mothers.
NEW YORK - A federal appeals court reversed the exclusion of plaintiff experts who say the use of acetaminophen by pregnant women can cause autism and attention deficit/hyperactivity disorder, reviving litigation that Health and Human Services Chair Robert F. Kennedy Jr. has long championed.
A three-judge panel of the Second Circuit Court of Appeals ruled that Judge Denise Cote had overstepped her authority by deciding that three experts, including the dean of the Harvard School of Public Health, had misinterpreted epidemiological studies and engaged in cherry-picking to eliminate evidence that didn’t support their conclusions.
In a 64-page opinion, Judge Guido Calabresi chastised his colleague for inserting her own opinions into a process designed only to make sure expert witnesses adhere to generally accepted scientific methods.
“The district court erred in deeming their testimonies unreliable and therefore not worthy of consideration by a jury,” Judge Calabresi wrote in the July 13 ruling.
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 were Ashley Keller of Keller Postman, Mikal Watts of Watts Guerra and Mark Lanier of The Lanier Law Firm. Kennedy has since provided valuable support to their 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.
Judge Calabresi said the Second Circuit acknowledged 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.
Judge Cote criticized Dr. Baccarelli for sidestepping the key dose-response test because none of the studies he cited included actual amounts of acetaminophen taken by pregnant women. But Judge Calabresi disagreed, saying Judge Cote’s ruling “penalized Baccarelli for using a methodology that epidemiologists routinely use.”
A jury might conclude Dr. Bacarrelli’s methods are unreliable for the same reasons as Judge Cote did, he wrote, “but that does not render the expert opinion excludable.”
Judge Calabresi also rejected Judge Cote’s conclusion Dr. Baccarelli had downplayed or ignored studies that didn’t support his conclusions.
“It is not cherry-picking for an expert to prefer one study to another when he offers a coherent, scientifically plausible reason for the preference.”
The Food and Drug Administration opened a study in 2014 and has revisited the evidence repeatedly without finding a connection. But in 2021 a panel of experts issued a “consensus statement” concluding pregnant women should limit their use of acetaminophen because of a possible risk of autism and ADHD. Plaintiff lawyers immediately recruited thousands of people to sue Johnson & Johnson, Walgreens and other companies. The MDL in New York holds about 500 cases but thousands more have been filed in state courts.
Following Kennedy Jr.’s announcement of the FDA investigation, Tylenol-maker Kenvue went on the market. Kimberly-Clark bought it last year for around $40 billion, and Texas Attorney General Ken Paxton, a U.S. Senate hopeful, has sued Kenvue and J&J over the same claims made by Kennedy Jr.
The experts were excluded under Rule 702 of the Federal Rules of Civil Procedure, which was amended in 2023 to end what critics said was a “hands-off” approach leaving the question of expert reliability almost entirely to juries. Judge Calabresi acknowledged the rules had changed, but said courts must “strike a middle-ground,” “taking a hard look at the expert’s opinions to ensure that they are reliable without necessarily addressing whether they are correct.”
“We recognize that this is easier said than done, but we trust the district courts to perform this inquiry and afford them substantial discretion in doing so,” he wrote.
