STORY FROM: Drugs & Medical Devices

Off-Label Promotion Claims in Sculptra Case Federally Preempted, N.Y. Appellate Court Affirms

NEW YORK — Claims accusing the manufacturers of Sculptra of encouraging use of the injectable filler in an off-label manner are federally preempted because they require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA, a New York appellate court has affirmed.

In a May 12 order, the New York Appellate Division, 1st Department, upheld a trial court’s ruling that the plaintiff’s claims seek to impose state law requirements that are “different from, or in addition to” federal regulations.

In 2008, Lisa Pitkow received facial injections of Sculptra, an injectable poly-L-lactic ...

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