Johnson & Johnson Seeks Interlocutory Appeal of Tylenol Lawsuit Preemption Order

After a U.S. District Judge rejected a motion to dismiss all federal Tylenol lawsuits brought by families of children diagnosed with autism or attention deficit hyperactivity disorder (ADHD), Johnson & Johnson has filed a request for certification of an interlocutory appeal, which would allow it to immediately ask a higher court to determine whether the failure to warn claims should be preempted by federal law.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the belief among consumers and the medical community that it poses little risk to developing children. However, a series of studies linking Tylenol and autism been published in recent years which indicate that in utero exposure may increase the risk that a child is later diagnosed with autism or ADHD.

More than 100 families are currently pursuing a lawsuit alleging Tylenol caused autism or ADHD, indicating that the drug maker violated state law by failing to warn pregnant women about the risks. However, it is widely expected that thousands of lawsuits will ultimately be brought in the coming months and years.

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).

Tylenol Lawsuit Preemption Order

In February, Johnson & Johnson filed a motion to dismiss all Tylenol autism and ADHD lawsuits, arguing that the state law-based failure to warn claims are preempted by federal regulations promulgated by the FDA, which govern how over-the-counter medications are manufactured and marketed to consumers.

Johnson & Johnson asserted that it was prevented by federal law from adding more stringent pregnancy label warnings to the Tylenol label, and that it would put state laws in conflict with federal regulations if the claims are allowed to proceed.

However, Judge Cote rejected that argument on April 20 in a Tylenol lawsuit preemption order, in which she determined that Johnson & Johnson could have added warnings about the risks of in utero exposure to acetaminophen without violating federal law.

In response, Johnson & Johnson filed a motion (PDF) to certify the Tylenol lawsuit preemption order for an interlocutory review, which allows an appeals court to consider the issue before a final judgment is issued about whether any individual child’s ADHD or autism diagnosis was caused by acetaminophen in Tylenol.

The request outlines Johnson & Johnson’s disagreement with the order, indicating that there are controlling questions of law where there could be reasonable disagreement. It also notes that the outcome of the Tylenol preemption appeal will have a major impact on the litigation.

The company called for an immediate appeal, arguing that the results would materially advance the litigation to its conclusion. The motion also noted that if it succeeded it would lead to the dismissal of claims involving hundreds of other plaintiffs, which would effectively end the litigation early in the pretrial proceedings.

May 20223 Tylenol 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.

In January 2023, 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, if the court’s preemption order decision stands, 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.