ADHD and Autism Lawsuits Over Acetaminophen Prenatal Exposure Cleared To Move Forward Against Walmart

The U.S. District Judge recently appointed to preside over all federal ADHD and autism lawsuits filed over acetaminophen prenatal exposure has rejected a motion to dismiss two claims filed against Walmart, finding that the failure to warn claims are not pre-empted by federal law and can proceed.

A multidistrict litigation (MDL) was established last month, centralizing all lawsuits over the Tylenol active ingredient filed throughout the federal court system before Senior U.S. District Judge Denise Cote in the Southern District of New York, for coordinated discovery into common issues in the claims and to prepare a group of “bellwether” claims for early trial dates to gauge how juries are likely to react to certain evidence and testimony that will be repeated throughout the claims.

Each of the claims allege that women were not adequately warned their children may develop attention deficit hyperactivity disorder (ADHD) or autism from prenatal exposure to Tylenol or other acetaminophen-based pain medications.

While most of the current complaints are pursuing damages from retailers who sold the acetaminophen medications, including Walmart, CVS, Walgreens, Costco and other companies, it is widely expected that the size and scope of the litigation will increase dramatically in the coming months, and will likely include several thousand Tylenol autism lawsuits that will eventually be brought against Johnson & Johnson for it’s role in causing the widespread use of acetaminophen during pregnancy.

On June 7, plaintiffs Robin Hatfield and Lisa Roberts filed two separate ADHD and autism acetaminophen lawsuits against Wal-Mart Stores, Inc. indicating their children were born with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD), because they took the retailer’s store-brand acetaminophen painkiller, sold under the Equate label, during pregnancy.

Walmart filed a motion to dismiss the lawsuits, arguing that the claims are preempted by federal drug labeling laws.

On November 14, Judge Cote issued an opinion and order (PDF) denying the motion and clearing the cases to proceed, saying there were no laws stopping Walmart from adding ADHD and autism warnings to its over-the-counter generic drug.

“It is a foundational principle for OTC drugs, as it is for brand-name drugs issued through an NDA, that a manufacturer is responsible for the adequacy of the warnings on its drug label,” Judge Cote wrote. “The regulation of acetaminophen generally and the Pregnancy Warning regulation in particular do not alter that responsibility.”

Walmart also tried to argue that its role as the retailer does not include responsibilities for label warnings. However, Judge Cote noted the lawsuits name Walmart as the retailer and manufacturer, making that argument moot.

Acetaminophen Autism Risks

The litigation comes in the wake of recent studies highlighting the risk that prenatal exposure to Tylenol increases the autism and ADHD risks.

In October 2019, a study published in the medical journal JAMA Psychiatry found children with the highest levels of acetaminophen metabolites in their blood at birth had the highest risk of the developmental disorders.

According to additional research published in the European Journal of Epidemiology in June 2021, children exposed to Tylenol during pregnancy were 19% more likely to have autism spectrum disorders and 21% more likely to have ADHD symptoms compared to non-exposed children.

Due to the potential acetaminophen pregnancy risks, researchers from Columbia University warned that doctors should re-evaluate the role of the pain medication for pregnant women in 2020, after finding that prenatal exposure may lead to impaired neurodevelopment in the fetus.

Following the coordinated discovery and any bellwether trials in the Tylenol MDL, if leadership attorneys fail to negotiate ADHD and autism settlements for families, Judge Cote may then start remanding each individual claim back to the U.S. District Court where it was originally filed for a future trial date.

Judge Cote has scheduled an initial status conference for the litigation for November 17.