Lawsuits alleging Tylenol can cause autism received a boost this week when the testimony of some plaintiff experts was deemed admissible
NEW YORK – Companies caught in lawsuits claiming acetaminophen causes autism are seeking relief from a recent ruling that revived those cases.
Walgreen, CVS, Target and others recently asked the U.S. Court of Appeals for the Second Circuit to review a three-judge panel’s decision to allow plaintiff lawyers to introduce experts who claim a link between prenatal use of the pain-relief medicine and autism and ADHD.
The next step for those pharmacies, plus Tylenol-maker Kenvue, was to ask for the full roster of Second Circuit judges to hear their arguments that the panel failed to exercise gatekeeping authority under the new version of Rule 702, which would allow jurors to hear science they claim is unreliable.
“(T)he panel did not seriously grapple with amended Rule 702,” a petition filed Thursday says. “Instead, it only briefly acknowledged the amendments, downplaying their significance.”
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 were 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.
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.”
Following Kennedy Jr.’s announcement of the FDA investigation, 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.”
