MDL Judge Finds Tylenol Autism, ADHD Lawsuits Against J&J Are Not Preempted

The ruling means that Tylenol lawsuits over the failure to warn about the risk of autism and ADHD lawsuits can move forward in the federal court system

The U.S. District Judge presiding over all federal Tylenol autism and ADHD lawsuits has determined that the failure to warn claims being pursued by families nationwide are not preempted by federal regulations, rejecting a request by Johnson & Johnson to have the litigation dismissed early in the proceedings.

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 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.

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.

Tylenol Autism Lawsuit

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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.

Judge Rejects Tylenol Autism, ADHD Lawsuit Preemption Defense

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).

On February 10, Johnson & Johnson Consumer, Inc. (JJCI) filed a motion to dismiss all short form complaints filed by families pursuing Tylenol autism and ADHD lawsuits, arguing that the state law-based failure to warn claims should be preempted by federal regulations promulgated by the FDA, which govern how over-the-counter medications are manufactured and marketed to consumers.

Johnson & Johnson asserted 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.

In an order and opinion (PDF) issued by Judge Cote on April 20, the Court rejected the argument, indicating that the claims can move forward.

“Neither the Supreme Court nor any circuit court has addressed preemption in the context of the Pregnancy Warning or the monograph system,” Judge Cote wrote. “The dispositive question is: could JJCI have added a truthful warning about the risks of in utero exposure to acetaminophen labels without violating federal law? The answer is yes.”

May 20223 Tylenol Lawsuit Update

While litigation continues to grow, Judge Cote has indicated the court 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 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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