FDA Will Not Provide Views on Acetaminophen Pregnancy Warnings in Tylenol Autism Lawsuits

The U.S. Food and Drug Administration (FDA) has declined an invitation made by the federal judge presiding over all Tylenol autism lawsuits to provide the agency’s position about pregnancy warnings for over-the-counter acetaminophen medications, indicating that the Court should rely on its existing epidemiological assessments instead.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the widespread belief that it is safe for unborn children. However, a growing number of lawsuits are now being pursued by families nationwide, each raising similar allegations that drug makers failed to adequately warn pregnant women about the growing evidence that in utero exposure to acetaminophen may cause autism or ADHD.

Given common questions of fact and law over the adequacy of the Tylenol pregnancy warnings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings late last year, centralizing all lawsuits brought throughout the federal court system before U.S. District Judge Denise Cote in the Southern District of New York, as part of a federal multidistrict litigation (MDL).

As part of the coordinated pretrial proceedings, Judge Cote has prioritized discovery into the link between link between Tylenol and autism, as well as ADHD and other developmental problems reported among women. However, the size and scope of the litigation continues to increase as families realize that their child’s diagnosis may have resulted from exposure to acetaminophen before birth.

In April 2023, plaintiffs in the litigation submitted a template of proposed Tylenol pregnancy warnings that drug makers could have provided for consumers, disclosing that some studies show frequent use of acetaminophen may increase a child’s risk of autism and ADHD. The proposed warnings also recommended that pregnant women use of the lowest effective dose for the shortest possible time to avoid risk to their unborn children.

Although plaintiffs’ lawyers have maintained that it is not a required element of their claims for families to provide any specific alternate warning language, Judge Cote asked the FDA weigh in on the proposed acetaminophen autism and ADHD warnings, including whether regulators thought the current science warrants such advice for pregnant women.

FDA Refuses to Weigh in on Tylenol Label Warnings

Although the the U.S. Attorney for the Southern District of New York, Damian Williams, told the Court in July that the FDA needed more time to put together its response to the Tylenol warnings dispute, this week the Department of Justice sent another letter (PDF) to the Court, indicating that the FDA has decided not to express its own opinion on the label warnings.

“The United States respectfully declines the Court’s invitation to submit a statement of interest in this matter, but attaches a copy of FDA’s literature review, dated March 10, 2023, providing FDA’s most recent review of available epidemiological evidence,” the letter states. “Since 2014, FDA has conducted multiple reviews of relevant epidemiological data concerning prenatal exposure to acetaminophen.”

Those reviews, including the latest, indicated that “limitations and inconsistent findings” are unable to support a determination of causation, Williams stated.

On September 9, plaintiffs filed a letter in response (PDF), indicating that there is ample evidence of a causal link between acetaminophen and autism.

“Dozens of potential confounders have been explicitly controlled for in the scientific literature, and they do not explain the results: Consuming acetaminophen while pregnant increased the risk of ASD and ADHD in offspring for drinkers and teetotalers, for smokers and non-smokers, for mothers with a febrile illness and those who never had a temperature,” plaintiffs’ letter states. “Specificity studies show that other, similar drugs taken while pregnant—such as ibuprofen and aspirin—did not cause an increase in ASD and ADHD rates, suggesting an effect unique to acetaminophen alone.”

Plaintiffs say the strength of association, consistency of findings, dose response data, and the fact that exposure appears to precede the onset of the disease, as well as biological plausibility all point to a causal connection between Tylenol use during pregnancy and autism.

September 2023 Tylenol Autism and ADHD Lawsuit Update

While litigation continues to grow, Judge Cote is expected to hold a series of hearings later this year, known as Daubert hearings, at which time the Court will evaluate the strength and reliability of proposed expert testimony submitted by each side about whether Tylenol causes autism and ADHD.

Unless the drug makers are able to entirely dismiss the lawsuits at this stage, it is expected that Judge Cote will then establish a “bellwether” process, where a small group of representative cases will be selected for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Although the outcome of such bellwether trials will not be binding on other families pursuing lawsuits, the average payouts awarded by juries may influence the amount of any Tylenol settlements Johnson & Johnson and other drug makers may offer families in the future, to avoid the need for each individual case to go to trial in the coming years.