FDA To Weigh in on Tylenol Warnings About Autism, ADHD by September 15

With a growing number of Tylenol lawsuits being pursued by families that allege inadequate pregnancy warnings were provided about the risk autism and attention deficit hyperactivity disorder (ADHD), the U.S. government indicates that the FDA will submit it’s views on the labeling for over-the-counter acetaminophen products by September 15.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the widespread belief that it was safe for unborn children. However, lawsuits now allege that the drug makers have failed to disclose information about the growing evidence that in utero exposure to acetaminophen may cause autism or ADHD.

Earlier this year, plaintiffs in the litigation submitted a template of proposed acetaminophen pregnancy warnings that could have been provided for consumers, recommending pregnant women the use of the lowest effective dose for the shortest possible time.

Although plaintiffs’ lawyers maintain that it is not necessary for families to provide any specific alternate language as a required element of their claims, the government’s input may play a crucial role in nearly 200 lawsuits being pursued against Johnson & Johnson, as well as major retailers who sold generic versions of the pain medication, including Walmart, CVS, Walgreens, Costco and others.

Each of the complaints raise similar allegations, indicating that information has been available to the manufacturers for decades about the link between autism and Tylenol, as well as ADHD, and other developmental problems. However, rather than warning about the acetaminophen risks, the drug has been actively promoted as safe for use by pregnant women.

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).

FDA to Weigh in on Tylenol Lawsuit Label Warning Dispute

In April 2023, Judge Cote invited the U.S. Food and Drug Administration (FDA) to weigh in on the proposed warnings and provide the views of the U.S. government, including whether regulators think the plaintiffs’ proposed language should be added to acetaminophen labels and whether the current science warrants such warnings or advice for pregnant women regarding the risk of autism or ADHD. The Court asked for the FDA to submit comments by July 28, 2023, or as soon thereafter as possible.

This week, the U.S. Attorney for the Southern District of New York, Damian Williams, sent a response letter (PDF) on behalf of the FDA, indicating the agency needs more time to put together its response.

“The United States appreciates the Court’s consideration and had hoped to submit a response by July 28, but respectfully requests an enlargement of this date until September 15, 2023,” according to the letter. “The United States requires additional time to complete internal deliberations on this matter, especially given the schedules and availability of a number of key agency personnel whose input is needed.

In an order (PDF) issued on the same day, Judge Cote agreed to extend the deadline for any FDA opinion the Tylenol pregnancy warnings until September 15.

“The submission of a Statement of Interest will be of importance to all the parties in this litigation, and the Government may of course take whatever time it needs to make the submission informative and useful,” Judge Cote wrote. “The Daubert motions in this litigation are due to be filed on Tuesday, September 19, and the parties would no doubt appreciate having as much time as possible before that date to consider the Statement of Interest.”

August 2023 Tylenol Autism and ADHD Lawsuit Update

While litigation continues to grow, Judge Cote has indicated the MDL will prioritize the early pretrial proceedings on discovery that focuses on the strength of the evidence that Tylenol causes autism and ADHD, and has appointed a special master to oversee discovery issues that arise.

A series of hearings are expected later this year, known as Daubert hearings, where the Court will evaluate the strength and reliability of proposed expect testimony submitted by each side.

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.