Tylenol
NEW YORK – Pharmaceutical manufacturers are among those urging a federal appeals court to rethink a decision that allowed lawyers to pursue claims linking Tylenol and related products to autism.
A round of friend-of-the-court briefs came in the case in late September, with the Pharmaceutical Research and Manufacturers of America arguing that allowing experts to testify acetaminophen use by pregnant women can lead to autism in their children flies in the face of federal rules on reliable testimony.
Rule 702 requires judges to act as gatekeepers to prevent scientific theories that are unsupported from being told to juries. PhRMA is worried about the consequences of a Second Circuit decision, reached this year by a three-judge panel, that allows experts to testify to an alleged link to the products and autism and ADHD.
“First, despite extensive research into the potential causes of autism spectrum disorder and (ADHD), no major regulatory body or medical organization, let alone the scientific community more broadly, has concluded that prenatal acetaminophen use causes either disorder,” the group wrote.
“Novel driving causes of these disorders will not be unearthed as part of civil tort litigation. The courtroom is not a laboratory, and Rule 702 exists to ensure that a jury is not asked to speculate about scientific questions.”
The brief is part of a fight to sway every judge on the Second Circuit to rehear the case. Among the defendants are Walgreen, CVS, Target and Tylenol-maker Kenvue raised the same gatekeeping concerns when they filed their petition for rehearing.
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 its brief, 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.”
The dangers of litigation are outlined in the brief. Lawsuits tied the anti-nausea medicine Bendectin to birth defects, leading to its removal from the market and a 30-year gap during which pregnant women feeling those effects had no other FDA-approved medication to turn to.
In 2013, the FDA approved Diclegis, which is rebranded Bendectin now deemed safe. Lawsuits had failed because of unsupported science and led to a landmark U.S. Supreme Court ruling that forced judges to scrutinize experts more.
“The bedrock principle that law must lag science does not limit access to justice, but instead ensures that binding legal outcomes with profound consequences beyond the courtroom are grounded in reliable scientific knowledge, not conjecture,” PhRMA wrote.
