J&J Spinoff Kenvue Defeats Suits Alleging Tylenol Causes Autism

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(Bloomberg) — Kenvue Inc., a Johnson & Johnson spinoff, won’t have to face lawsuits alleging prenatal exposure to over-the-counter painkiller Tylenol caused autism after a judge rejected the scientific evidence behind the cases.

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US District Judge Denise Cote in Manhattan concluded Monday that plaintiffs in more than 400 suits accusing Kenvue and other makers and sellers of acetaminophen relied on flawed science in seeking to prove an increased risk of developmental issues in babies. The ruling effectively kills a consolidation of the cases before Cote.

Kenvue shares were up nearly 5% in Tuesday morning trading. 

In her pretrial ruling, Cote found that plaintiffs’ scientific experts couldn’t show legitimate links between Tylenol and autism attention-deficit problems or hyperactivity, making the cases legally unsustainable. The experts didn’t use a “reliable application of scientific methods” in accessing the causal links between the drug and the ailments, Cote concluded in a 148-page ruling.

The decision is a relief for Kenvue investors, who were bracing for the newly public company to face years of costly litigation over claims Tylenol was one of the causes of autism, a disease that affects as many as 75 million people around the globe.

Kenvue hailed Cote’s ruling, saying the judge relied on the US Food and Drug Administration’s guidance that Tylenol doesn’t cause autism or other ailments. 

“These lawsuits have created confusion on the safety of one of the most studied medications in history,” Melissa Witt, a company spokeswoman, said Tuesday in an emailed statement. 

Kenvue took on the Tylenol liability when it was spun off from the world’s largest health-care products company, which was seeking to segregate its consumer-health business. Other Kenvue brands include Band-Aids, Benadryl and Listerine mouthwash. Kenvue also inherited any lawsuits filed outside the US and Canada over claims that asbestos in its J&J baby powder caused cancer.

The case is In RE: Acetaminophen/ASD-ADHD Product Liability Litigation, 22-mc-03043, US District Court for the Southern District of New York (Manhattan)

—With assistance from Julie Steinberg.