U.S. High Court Won’t Review Medical Device Off-Label Preemption Debate

(January 12, 2016, 8:31 AM EST) -- WASHINGTON, D.C. — The U.S. Supreme Court on Jan. 11 declined to decide if its medical device preemption precedents preempt claims involving the off-label use of the Infuse bone graft (Patricia Caplinger v. Medtronic, Inc., et al., No. 15-321, U.S. Sup.).

In 2010, Patricia Caplinger underwent lumbar spine surgery to treat a degenerative disc condition. Her surgeon used the Infuse bone graft made by Medtronic Inc., but he implanted it via a posterior approach, for which the device was not approved.

Caplinger alleges that a Medtronic...
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