2nd Cir. Upholds Dismissal of Infuse Action, Says Warning, Defect Claims Federally Preempted

NEW YORK — Warning and design defect claims asserted against Medtronic Inc. in an Infuse bone graft case are preempted because they seek to impose safety-related requirements beyond those imposed by the Food and Drug Administration, a federal appeals court has ruled.

In a June 9 summary order, the 2nd Circuit U.S. Court of Appeals further held that the plaintiff’s fraud claims were not pled with the requisite particularity and were therefore properly dismissed.

The Infuse device consists of a collagen carrier sponge (BMP/Sponge) soaked with liquid protein rhBMP-2, known as the “Infuse Bone Graft Component” and a metallic cage …