The Second Circuit denied Kenvue’s subsidiary a rehearing, leaving in place a ruling that revived approximately 550 cases. Three plaintiffs’ experts may testify, but the families still must prove their claims.
About 550 federal suits alleging harm from acetaminophen taken during pregnancy were reopened, with Tylenol maker Kenvue’s subsidiary and retailers including CVS and Walmart among the defendants. Parents suing as guardians allege the medicine caused autism or ADHD and that its sellers failed to warn them. On October 16, the Second Circuit denied a rehearing request from Kenvue’s subsidiary, Johnson & Johnson Consumer Inc. The denial leaves in force a July ruling that let three plaintiffs’ experts testify even where scientists disagree, sending approximately 550 cases back to New York.
Class action news site OpenClassActions quotes a July Kenvue statement saying that “credible, independent science shows no proven link” between taking acetaminophen and autism or ADHD. The company’s position meets a narrower court ruling: the appeals judges decided which expert opinions a jury may hear, not whether acetaminophen caused any child’s condition.
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The parents’ claims had been stopped before trial. In the federal litigation gathered before District Judge Denise Cote, the plaintiffs offered five experts on whether prenatal acetaminophen exposure can cause autism or ADHD. Judge Cote excluded all five and granted judgment to the defendants in approximately 550 cases. Without admissible evidence on that general question, those plaintiffs could not reach a jury.
The Second Circuit’s July opinion changed that position. It held that Judge Cote went too far in excluding three of those experts, Andrea Baccarelli, Eric Hollander and Brandon Pearson. The panel said their interpretations of the scientific evidence were sufficiently reliable to be heard, even where scientists disagree about the answer. A judge could scrutinize their methods, the panel reasoned, without deciding for a jury whether their conclusions were persuasive.
That distinction carries the case. The panel also upheld the exclusion of the other two experts, Robert Cabrera and Stan Louie. It held that Judge Cote was entitled to conclude that Cabrera had not explained the weight he gave each factor in his analysis, and that Louie had not explained how he got from the studies he examined to his conclusion about dose and duration of exposure. The ruling opened the door to three experts, not every opinion the plaintiffs offered.
A separate group of plaintiffs had offered another expert, Roberta Ness, after the first five experts were excluded. The appeals court sent those cases back too, leaving Judge Cote to reconsider Ness’s testimony if the plaintiffs still seek to use it. The families have regained a path to present their case; they have not won the causation fight.
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The defendants also argued that federal drug labeling rules barred the families’ state law claims that they should have received a warning. The Second Circuit rejected that route to dismissal. It held that the federal regulations requiring a general pregnancy warning do not prohibit supplemental, specific warnings against plausible risks. That keeps the alleged failure to warn in play alongside the dispute over the science. **Analysis:** the Daubert exit (excluding the other side’s expert testimony) narrowed here: three plaintiffs’ experts may testify, and the jury weighs how persuasive their conclusions are.
The October order was short. It identified Johnson & Johnson Consumer Inc. as the party seeking either another hearing before the panel or a hearing before the full appeals court, then denied the request. The appellate docket records motions to file amicus briefs by retailers including Walgreen, Costco and CVS; the U.S. Chamber of Commerce with the American Tort Reform Association; the National Association of Manufacturers; and pharmaceutical industry group PhRMA.
Kenvue’s August securities filing identifies Johnson & Johnson Consumer Inc. as its subsidiary, now called Kenvue Brands LLC. It reports $7.864 billion in net sales for the first six months of 2026, a companywide figure rather than an amount at issue in these suits. Kenvue says product liability suits continue to be filed and that it cannot reasonably estimate the likelihood or size of its potential liability from the claims.
The same filing describes a separate action by the state of Texas. Kenvue says Texas alleged violations of state law concerning claims about acetaminophen exposure and child development. Kenvue reports that the claims against Kenvue itself and Johnson & Johnson, and some claims against Kenvue Brands LLC, were dismissed in November 2025, and that a notice of appeal was filed in December 2025; the Second Circuit’s ruling concerns the federal families’ suits.
OpenClassActions reports, citing Reuters, that a Kenvue spokesperson said the company plans to seek Supreme Court review. The October 16 order itself decides only rehearing in the Second Circuit. Meanwhile, the July opinion sends the federal cases back to Judge Cote for further proceedings.
Three experts whose exclusion had ended approximately 550 cases may now be heard. Whether acetaminophen can cause autism or ADHD, whether it caused any particular child’s condition, and whether a warning was required remain open in the federal cases remanded to Judge Cote in New York.
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