The judge in the consolidated multidistrict litigation, which claims painkiller Tylenol can cause autism in children if their mothers take it during pregnancy, dealt plaintiffs a potentially fatal blow by barring their expert witness testimony in a December 18 hearing in Manhattan federal court. Plaintiffs will have to win a reverse on appeal to revive approximately 500 lawsuits.
U.S. District Judge Denise Cote ruled that expert witnesses for plaintiffs who tried to pin liability on Tylenol’s owner, Kenvue, a Johnson & Johnson spin-off, as well as retailers, did not present adequate scientific evidence to support their conclusions vilifying the over-the-counter drug’s main ingredient acetaminophen.
Judge Cote issued a 148-page ruling that found none of the five expert witnesses offered credible and sound scientific backing to the claim acetaminophen could cause attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in children of mothers who used Tylenol during pregnancy.
Judge Cote called the experts’ approach unstructured, finding that they cherry-picked results that suited their position and downplayed or obscured data that did not support the conclusions they were promoting.
Pharmaceutical product liability lawsuits depend heavily on expert testimony that it was foreseeable the product caused the alleged harm. Judges admit or deny their testimony by relying on scientific standards adopted in the 1993 U.S. Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals.
Kenvue, Johnson & Johnson’s consumer health subsidiary prior to being spun off in August 2023, responded by saying it would ask for dismissals of all the current cases. Kenvue’s stock rose four percent on the news.
A Kenvue spokesperson claimed that acetaminophen has been widely and thoroughly studied and is one of the most popular recommendations physicians make when a patient has a fever or pain during pregnancy. The company said treating these conditions with Tylenol or other acetaminophen products is safer than the serious health issues that could arise by not treating them, and the mass tort litigation has caused public confusion about the product’s safety.
Plaintiffs also targeted nationwide retailers that marketed Tylenol and their branded, generic version of Tylenol. Retailers included Walgreens, CVS, and Walmart. Retailers previously stated that their acetaminophen products were properly labeled to federal standards, and they should not be liable because they are not manufacturers.
Defendants began filing lawsuits against retailers early in 2022, claiming they failed to warn consumers about the neurological risks to fetuses. Judge Cote consolidated the multidistrict litigation in October 2022. Tylenol and acetaminophen products are recommended widely over ibuprofen and aspirin, which pose a known risk for fetal organ damage.
Although medical experts acknowledge that limited studies have linked ASD and ADHD to acetaminophen use during pregnancy, they also call for additional testing because other factors could be responsible for the fetal conditions.
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