In a landmark decision on Monday, a U.S. District Judge in Manhattan, Denise Cote, dealt a decisive blow to a consolidated mass tort litigation involving approximately 500 lawsuits against Johnson & Johnson’s spin-off, Kenvue, over claims that the painkiller Tylenol could cause autism if taken during pregnancy. The judge’s ruling effectively bars expert witnesses from testifying in support of the plaintiffs’ allegations, asserting that their conclusions lacked the necessary scientific backing.
Judge Cote’s 148-page ruling scrutinized the methodologies presented by five expert witnesses proposed by the plaintiffs, finding them deficient in establishing a credible scientific basis linking Tylenol’s active ingredient, acetaminophen, to autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD). She criticized the unstructured approach of the experts, emphasizing that it allowed cherry-picking, facilitated a results-driven analysis, and obscured the complexities and weaknesses in the underlying data.
Kenvue, previously Johnson & Johnson’s consumer health unit before its August spin-off, responded to the ruling by announcing its intention to dismiss all the cases related to Tylenol. The company highlighted the confusion created by the lawsuits, stating, “Acetaminophen is recommended by doctors as a first-line treatment option for people who have a fever or are experiencing pain during pregnancy. It is scientifically known that not treating these conditions may have serious health consequences for both mother and baby.”
The legal battle also implicated retailers selling generic versions of Tylenol, such as CVS, Walgreens, and Walmart. CVS and Walgreens declined to comment on the decision, while Walmart did not immediately respond to requests for comment.
Product liability lawsuits, including those concerning Tylenol, rely on expert testimony to establish the product’s potential for causing harm. Federal judges, guided by scientific standards outlined by the U.S. Supreme Court in the 1993 Daubert v. Merrell Dow Pharmaceuticals ruling, determine the admissibility of such expert testimony.
The multidistrict litigation, consolidated before Judge Cote in October 2022, centered on allegations that retailers failed to warn pregnant users of acetaminophen products about potential neurological risks to the fetus. Despite some studies suggesting an association between acetaminophen use during pregnancy and the targeted disorders, health experts caution that underlying factors may be responsible, emphasizing the need for further research.
As the legal landscape surrounding Tylenol and autism undergoes a significant shift, the plaintiffs face an uphill battle, with the judge’s ruling likely spelling the end of this high-profile mass tort litigation unless successfully appealed.
