Litigation risks tied to acetaminophen and pregnancy are shifting to the U.S. Court of Appeals for the Second Circuit, where oral arguments begin Nov. 17.
The hearing follows Judge Denise Cote’s decision in multi-district litigation to exclude expert testimony that sought to link acetaminophen use during pregnancy with autism and ADHD.
A ruling may not come until December 2025 or the first quarter of 2026. Kenvue Inc. is at the center of the case.
The consolidated litigation was filed in the Southern District of New York in 2022, combining more than 500 plaintiffs under the question of whether acetaminophen causes autism or ADHD.
Judge Cote applied the Daubert standard in evaluating expert evidence and found that plaintiffs’ medical experts failed to prove causation. Her ruling rendered their testimony inadmissible, a decision now under review by the appeals court.
The appellate court will apply the abuse of discretion standard, which generally defers to a trial judge’s findings unless the ruling was “completely out of bounds,” said George Washington University law professor Paul Schiff Berman on a Barclays call discussing the case.
“So long as the initial decision was in the realm of reasonableness (that is, the trial judge wasn’t completely out of bounds), the appellate court is likely to affirm the decision,” he said.
Plaintiffs have attempted to introduce recent statements from the Trump administration, which publicly highlighted concerns over acetaminophen and autism. But Berman said those views do not add new evidence.
“All of the evidence cited by the Trump administration appears to be the same as the evidence rejected by Judge Cote,” he said, adding that federal courts frequently overturn or decline to adopt executive agency positions.
State-level lawsuits remain a consideration. While state courts often look to federal precedent, they are not bound by an MDL ruling, and evidentiary rules differ across jurisdictions.
Statutes of limitations also vary, with some states measuring from the time of ingestion and others from when a person reasonably should have known of a possible claim.
Berman noted that plaintiff attorneys face economic hurdles in pursuing such cases, as they operate on contingency fees and face steep costs for expert witnesses and client recruitment.
Smaller pools of plaintiffs compared with federal cases could mean lower potential settlements.
The broader question is whether Kenvue knew or should have known about a causal connection.
Medical consensus and global health authorities have maintained there is no established link between acetaminophen and autism.
The Food and Drug Administration has acknowledged studies suggesting an association but concluded that “a causal relationship has not been established and there are contrary studies in the scientific literature.”
If litigation advances, plaintiffs would self-certify that they took acetaminophen while pregnant, as over-the-counter products like Tylenol are not prescribed and receipts are rarely kept.
Separately, the FDA has moved toward a label change to reflect a possible association between acetaminophen and autism/ADHD.
Reports indicate Kenvue may contest the decision, but Berman said a challenge would be unlikely to succeed.
“As long as there was sufficient evidence to support the label change (even if the evidence is thin), the court is not likely to overturn the decision,” he said.
Source :
https://www.investing.com/news/stock-market-news/litigation-risks-for-kenvue-focus-shifts-to-us-appeals-court-4267815
