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Hundreds of people who say they’ve been harmed by a Medtronic spinal device are pursuing a new legal pathway around rulings that have kept them from getting a day in court. They argue that the Food and Drug Administration, which approved limited use of the Infuse bone growth product in 2002, offered a 2008 warning to doctors about “life-threatening complications” from unapproved applications. Then, the Spine Journal in 2011 and the U.S. Senate Finance Committee in 2012 each harshly criticized Medtronic for allegedly paying physicians hundreds of millions of dollars to write scholarly articles about Infuse while editing those articles to downplay Infuse’s dangers. Yet for all the claims of poor performance, dangerous outcomes and shoddy scholarship, Infuse has never been the subject of a personal-injury trial because of a legal concept called “pre-emption.” That means federal law takes precedence over state law. The Supreme Court has extended this premise to say that almost no one can sue for damages caused by medical devices that received premarket approval from the FDA.
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