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Tylenol Autism Lawsuit Update – Dec. 2022

Timely Insights on Laws, Issues and New Developements

Wal-Mart Preemption Defense denied in Acetaminophen Autism Lawsuits

Tylenol autism lawsuits moved in the plaintiffs’ direction on November 14, 2022. On that day, Judge Denise Cote ruled against Walmart’s motion to dismiss the cases. The judge rejected the retail giant’s preemption argument.

Preemption Argument

Preemption is an argument often employed by drug manufacturers and retailers in mass tort litigation involving pharmaceutical drugs and devices. In the preemption play, the defendant argues that any state law cause of action is preempted by the FDA’s labeling policies. The FDA, they say, has complete control over the labeling of any drug or device, and FDA approval means a drug maker is free from civil liability in drug injury cases.

Preemption is governed by a precedent that was established in the U.S. Supreme Court case of Merck v. Albrecht. The Supreme Court ruled in that case that preemption is ultimately a question of law and must be decided by a judge rather than a jury. Another important ruling in Merck v Albrecht is that a defendant can prevail only if it establishes that it provided the FDA full justification of the need for a label change, and also that the FDA informed the defendant that the agency would not approve the label change.

Judge Cote’s Ruling

Judge Cote’s decision impacts every acetaminophen autism lawsuit pending in the Southern District of New York. Her order analyzed two cases that comprise the defendant’s motion to dismiss and assertion of the preemption defense: Hatfield et al. v. Wal-Mart Stores, Inc., 22cv9011; Roberts et al. v. Wal-Mart Stores, Inc., 22cv9012.

In both those cases, pregnant women took Equate brand Tylenol, Walmart’s OTC-equivalent acetaminophen brand. Equate brand Acetaminophen products are sold only at Walmart.

The mothers in both those cases say their children have been diagnosed with both autism and ADHD as a result of their mothers’ ingesting acetaminophen while pregnant. The plaintiffs also allege Walmart violated State law by failing to warn of the elevated risks of dangers linked to prenatal acetaminophen exposure.

Judge Cote stated in her ruling: “[A] manufacturer is responsible for the adequacy of the warnings on its drug label. The regulation of acetaminophen generally and the Pregnancy Warning regulation, in particular, do not alter that responsibility.” 

Plaintiffs can see this ruling as a victory for the Tylenol (acetaminophen) autism litigation. It means acetaminophen autism ADHD lawsuits are no longer dismissible by a preemption defense by any manufacturer or retailer of generic acetaminophen products. However, Walmart has not quit on this ruling.

Wal-Mart doubles down on Preemption Play to dismiss Tylenol Autism Lawsuits

On November 28, 2022, Walmart filed a memorandum of law in support of its motion for reconsideration of Judge Cote’s November 14th order denying Walmart’s preemption defense. Despite that ruling, Walmart continues to claim federal law preempts the plaintiff’s failure to warn arguments. Now, Walmart is asking Judge Cote to either certify a request to the U.S. Court of Appeals for the Second Circuit (an interlocutory appeal) or to reconsider her denial of preemption.

The judge then issued an Order giving plaintiffs until December 12, 2022 to file any pleadings to oppose Walmart’s memorandum of law. The future of Tylenol pregnancy lawsuits depends on the ruling. Walmart’s claim says that if the Second Circuit determines federal law preempts plaintiffs’ claims, “such a decision would likely dispose of all claims inside the MDL.”  That would essentially end the litigation.

However, plaintiffs’ attorneys in the cases believe it unlikely Judge Cote will grant Walmart’s motion for reconsideration, since no change has occurred in the controlling law. Further, they do not believe Judge Cote will certify an interlocutory appeal at this time.

Daubert Hearings yet to be held

Meanwhile, the plaintiffs have yet to to get past Daubert hearings. These are hearings which determine which “experts” will be considered “experts” by the court. Daubert hearings lead to rulings that determine who, and who will not, be allowed to testify before a jury, as well as what an accepted expert’s scientific evidence will be deemed admissible.

Autism Acetaminophen Lawsuits Consolidated

All acetaminophen lawsuits have been consolidated before Judge Denise Cote in United States District Court for the Southern District of New York. Judge Cote has assigned leadership positions for attorneys representing plaintiffs and defendants. She has also appointed lead counsel, liaison counsel, and members of the plaintiff’s steering committee for Tylenol autism lawsuits.


  • Tylenol Autism Lawsuit
  • Acetaminophen Alert from FDA
  • Tylenol in Pregnancy linked to Autism

by Matthews & Associates

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