The American Tort Reform Association today chided the 2nd Circuit Court of Appeals’ decision to revive more than 500 lawsuits alleging that Tylenol and generic acetaminophen cause autism and attention-deficit hyperactivity disorder when taken during pregnancy, calling the ruling a direct threat to the gatekeeping function Rule 702 demands of federal judges.
In a 3-0 decision, the 2nd Circuit overturned a December 2023 ruling by U.S. District Judge Denise Cote of the Southern District of New York. Judge Cote had applied the strengthened Federal Rule of Evidence 702 — which took effect Dec. 1, 2023 — to bar plaintiffs’ expert witnesses whose methodologies she found unreliable. She determined that the experts, including the dean of Harvard University’s public health school, had cherry-picked studies and failed to demonstrate that their conclusions rested on generally accepted science.
“Judge Cote did exactly what Rule 702 requires and the 2nd Circuit’s decision to reverse her is deeply concerning,” said Lauren Sheets Jarrell, ATRA’s vice president and counsel for civil justice policy. “Judge Cote scrutinized the methodology behind the plaintiffs’ experts, found it unreliable, and acted as the gatekeeper she is required to be.
“What the 2nd Circuit has done is create a roadmap for the plaintiffs’ bar to keep pressing forward with made-for-litigation science, shopping their theories until they find a court willing to put them before a jury. That is the Trial Lawyer Playbook in action, and it is precisely what strengthened evidentiary standards were designed to stop. The American College of Obstetricians and Gynecologists is unequivocal that acetaminophen is the analgesic of choice for pregnant patients — and there are no safe alternatives to acetaminophen for managing pain and fever.
“Sending 500-plus cases to trial on expert testimony a federal judge found methodologically unsound doesn’t protect patients. It puts the interests of trial lawyers ahead of the pregnant women these claims purport to help.”
Amended Rule 702 was designed specifically to strengthen judges’ gatekeeping obligations — requiring courts to assess not only an expert’s qualifications, but whether their methodology reliably supports their conclusions. The 2nd Circuit held that credibility questions belong to the jury once a methodology clears a threshold of scientific acceptance. ATRA warns that standard is too permissive and risks allowing the plaintiffs’ bar to use litigation-driven studies to reach juries that careful gatekeeping is meant to screen out.
ATRA urges federal courts to enforce the strengthened Rule 702 as written, giving full effect to the gatekeeping function that Congress and the rules committee intended.
