Tylenol MDL Judge Rejects J&J Request for Immediate Appeal of Preemption Ruling

Johnson & Johnson will not be allowed to pursue an interlocutory appeal of the Court's pre-emption decision, which allows Tylenol autism lawsuits to move forward over adequacy of the acetaminophen pregnancy warnings

The U.S. District Judge presiding over all Tylenol autism lawsuits brought by families throughout the federal court system has rejected a request filed by Johnson & Johnson, which sought an immediate appeal of the Court’s recent decision to deny the drug maker’s motion to dismiss the litigation.

Johnson & Johnson faces more than 100 lawsuits brought by families of children diagnosed with autism or attention deficit hyperactivity disorder (ADHD), each raising similar allegations that the drug maker failed to adequately warn families that in utero exposure to the acetaminophen-based pain medications may injury unborn children.

Early in the litigation, the drug maker sought to dismiss the Tylenol claims, arguing that any failure to warn lawsuits are pre-empted by federal law, since the U.S. Food and Drug Administration approved the medication and the warning label. However, the Court rejected that position in April 2023, finding that the Tylenol lawsuits are not preempted and can move forward toward trial.

Tylenol Autism Lawsuit

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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 have 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.

Given common questions of fact and law raised in Tylenol lawsuits filed throughout the federal court system, U.S. District Judge Denise Cote was appointed late last year to preside over coordinated pretrial proceedings, which are centralized as part of an MDL (multidistrict litigation) in the Southern District of New York.

Tylenol MDL Judge Rejects J&J Appeal Certification Request

In early May 2023, Johnson & Johnson filed a motion seeking to certify the Tylenol lawsuit preemption order for an interlocutory review, which would allow 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.

However, Judge Cote shot down those efforts in an Opinion and Order (PDF) issued on August 3, denying Johnson & Johnson Consumer Inc.’s (JJCI) request.

“JJCI’s motion for certification of an interlocutory appeal is denied,” Judge Cote wrote. “JJCI has not demonstrated that all of the… factors are met for an interlocutory appeal from either the Preemption Opinion or the Rule 8 Opinion.”

Judge Cote noted that Johnson & Johnson is basically making the same claims it made in its unsuccessful motion to have the cases dismissed, but failed to show “that there is a reasonable basis to disagree with the analysis in the Preemption Opinion.”

She also ruled that plaintiffs had brought enough convincing evidence and arguments that support their allegations that Tylenol exposure during pregnancy can cause ADHD or autism in offspring. Challenges to the science backing those claims will come later in the process, Judge Cote indicated.

August 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.


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