Tylenol Label Warning Complaint Dismissed With Judge's Federal Preemption Question Unanswered

Marketers of other drugs available under FDA OTC monograph should note dismissal of complaint against Kenvue didn’t resolve the judge’s questions about whether federal preemption precludes challenges to safety and labeling.

• Source: Shutterstock

Attorneys for plaintiffs alleging that labeling fails to warn about potential risks concerning prenatal use of Tylenol didn’t help their cause by failing to respond to a judge’s deadline for showing cause that their complaint shouldn’t be dismissed.

Marketers of other drugs with acetaminophen or other active ingredients available under a Food and Drug Administration OTC monograph may want to note, though, that dismissal of the complaint against Kenvue Inc

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