Caplinger v. Medtronic

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Medtronic, Inc. produced "Infuse," a device that stimulates bone growth to repair damaged or diseased vertebrae. When it approved the device for sale, the FDA required the company to include a warning label instructing that Infuse should "be implanted via an anterior" surgical approach. Patricia Caplinger brought a state law tort suit against Medtronic, alleging that Medtronic promoted Infuse for use in a posterior surgical approach, which was considered an off-label" use. Caplinger alleged that Medtronic’s conduct exposed the company to liability under a variety of state tort theories. But the district court held all of these state law claims either insufficiently pleaded or preempted. Agreeing with the district court's conclusion that Caplinger's state law claims were insufficiently pleaded or preempted, the Tenth Circuit affirmed. View "Caplinger v. Medtronic" on Justia Law