Tylenol MDL Judge Invites FDA To Weigh In on Pregnancy Warnings About Acetaminophen and Autism, ADHD

The U.S. District Judge presiding over all Tylenol autism and ADHD lawsuits has invited federal drug regulators to give their opinion about the pregnancy warnings that could have been added to acetaminophen-based pain medications.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the drug makers’ failure to disclose growing evidence that exposure in utero increases a child’s risk of developing autism or ADHD.

More than 100 families of children with ADHD or autism from Tylenol are now pursuing lawsuits against Johnson & Johnson, as well as major retailers who sold generic versions of the pain medication, including Walmart, CVS, Walgreens, Costco and others. However, it is widely expected that tens of thousands of claims will be brought in the coming months and years.

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 attention deficit hyperactivity disorder (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).

In January, Judge Cotes ordered plaintiffs to submit proposed language that could have been added to the acetaminophen labels, showing what the drug makers could have done to warn women about the risks of using Tylenol during pregnancy. Plaintiffs responded with a template of a proposed acetaminophen pregnancy  warning earlier this month.

Judge Cote issued an Invitation for Statement of Interest (PDF) on April 19, calling for the U.S. Food and Drug Administration (FDA) to review the plaintiffs’ proposed warning, and provide the views of the U.S. government.

The invitation calls for the FDA to submit comments by July 28, 2023, or as soon thereafter as possible. The judge wants to know whether regulators think plaintiffs’ proposed warning should be added to acetaminophen labels, and whether the current science warrants such a label warning or advice for pregnant women regarding the risks of autism and ADHD.

In a response letter (PDF) issued the same day, plaintiffs objected to the questions asked in the invitation, indicating that it implies plaintiffs are proposing that defendants should have modified or added the pregnancy warning.

“Plaintiffs already agree that Defendants could not and cannot unilaterally change or add to the Pregnancy Warning,” the letter states. “There is no sense asking the United States if a Warning Defendants cannot change should nonetheless be changed.”

Throughout the litigation, plaintiffs have argued that it is not necessary for families to provide any specific alternate language for the Tylenol pregnancy warnings, as a required element of their claims.

April 2023 Tylenol Lawsuit Update

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

In January, Judge Cote issued a court order detailing how the federal court will coordinate Tylenol lawsuit discovery proceedings with various state courts nationwide, where some families have filed their claims outside of the MDL.

As part of the coordinated pretrial proceedings, it is also expected that the court will 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. However, if the parties fail to negotiate Tylenol autism settlements or another resolution for the litigation in the MDL, each family’s lawsuit may eventually be remanded back to different U.S. District Courts nationwide for future trial dates.