Supreme Court declines to review Medtronic win in InFuse lawsuit

The U.S. Supreme Court yesterday declined to review a Medtronic (NYSE:MDT) win in a lawsuit alleging off-label promotion of its controversial InFuse bone-growth protein. Patricia Caplinger asked the high court last year 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 FDA. 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. Yesterday the high court declined, without comment, to grant Caplinger’s petition. 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 spin...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Legal News Medtronic Source Type: news