Product Liability: Discussions With FDA Remain Key In Defeating State Tort Suits

US Supreme Court says judges, not juries, should decide if FDA would have rejected additional label warning; Merck appears to have the support of three justices who note FDA's position that it decided not to require a change to Fosamax labeling.

US Supreme Court building with 2nd statue on right

The US Supreme Court unanimously ruled that it is up to judges rather than juries to decide whether FDA rejected a drug manufacturer's request to add a warning to its labeling. The court also held that a company must provide "clear evidence" that it fully informed FDA of the reasons for the proposed label change and that the agency told the company it would not approve the change.

In its 20 May ruling in Merck Sharp & Dohme Corp. v. Albrecht, the court remanded the question of whether state law claims that Merck & Co. Inc....

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