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Judge Dismisses Tylenol-Autism Link Lawsuits, Citing Lack of Scientific Support

In a significant legal development, a judge has ruled against expert witnesses who claimed that Tylenol, a painkiller produced by Johnson & Johnson’s spin-off Kenvue, could cause autism if taken by mothers during pregnancy. The decision, made by U.S. District Judge Denise Cote in Manhattan federal court on Monday, has far-reaching implications, potentially marking the conclusion of a consolidated mass tort litigation involving approximately 500 lawsuits related to the popular over-the-counter drug.

The judge’s 148-page ruling prevents the expert witnesses, proposed by the plaintiffs, from testifying that Tylenol’s active ingredient, acetaminophen, is linked to autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD). Judge Cote concluded that none of the five expert witnesses provided a scientifically sound methodology to support their opinions, criticizing their unstructured approach as allowing cherry-picking, results-driven analysis, and obscuring complexities in the underlying data.

Kenvue, the consumer health unit of Johnson & Johnson before its spin-off in August, welcomed the ruling and announced its intention to move for the dismissal of all the cases in light of this decision. The company emphasized the confusion created by these lawsuits and highlighted the established scientific knowledge that acetaminophen is recommended by doctors as a first-line treatment option for pain and fever during pregnancy.

The lawsuits not only targeted Kenvue but also retailers selling their own generic versions of Tylenol, including CVS, Walgreens, and Walmart. CVS and Walgreens refrained from commenting on the decision, while Walmart did not immediately respond to requests for comment.

Product liability lawsuits, such as those involving Tylenol, hinge on expert testimony to establish the product’s capability to cause alleged harm. Federal judges, following scientific standards outlined by the U.S. Supreme Court in its 1993 Daubert v. Merrell Dow Pharmaceuticals ruling, determine what expert testimony is admissible.

This multidistrict litigation, consolidated before Judge Cote in October 2022, originated from lawsuits filed earlier that year. Plaintiffs contended that retailers failed to warn pregnant users of acetaminophen products about potential neurological risks to the fetus. Health experts generally recommend acetaminophen over aspirin or ibuprofen for pregnant women, as the latter two can cause fetal organ damage. While some studies have suggested an association between acetaminophen use in pregnancy and certain disorders, researchers caution about underlying factors and advocate for further investigation. Lawyers for the plaintiffs have not yet responded to requests for comment on the recent ruling.


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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