Plaintiff takes Infuse case against Medtronic to the Supreme Court

The plaintiff in a product liability lawsuit asked the U.S. Supreme Court to take up the case, involving alleged off-label promotion of Medtronic‘s (NYSE:MDT) controversial Infuse bone-growth protein. Patricia Caplinger wants the high court to review an April decision by the U.S Court of Appeals for the 10th Circuit that her state-law tort claims are preempted by federal law. Caplinger had argued that her claims survived preemption because the device was used in a manner not approved by the Food & Drug Administration. In a Sept. 11 petition for certiorari, Caplinger asked the Supremes to decide “whether state-law claims based on injuries caused by a medical device are preempted where the device was not granted premarket approval for the particular use that caused the injuries and the manufacturer marketed the device for that unapproved use,” according to court documents. Caplinger had lumbar spinal fusion surgery in August 2010, in which her surgeon used an unapproved posterior approach to implant the Infuse device, according to the documents. By the fall of that year her symptoms returned and worsened; Caplinger developed a foot-drop condition in her right leg “resulting from exuberant bone growth caused by the use of Infuse,” according to the petition. In December 2010 the foot-drop condition caused a tear in her anterior cruciate ligament, leading to knee surgery early the next year. Caplinger had revision spine surgery in September ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Legal News Orthopedics Spinal Medtronic Resorbable bone materials Source Type: news