Medtronic patient sues over off-label Infuse injury
This article was originally published in Clinica
Medtronic is being sued by one of its patients who claims to have been seriously injured by the unapproved use of the firm’s Infuse bone graft implant. Representatives of Paul Antonelli say the plaintiff was injured in January 2006 during an off-label surgical procedure to fuse vertebrae in his spine, leaving him in agonising pain. The complaint alleges that Medtronic improperly promoted the use of the bone graft for cervical lumbar surgery, when the technology had not been approved by the FDA for that particular procedure. The FDA has received more than 200 reports of significant side effects resulting from off-label use of Infuse, particularly in the cervical spine. In December, the firm was sued by representatives of a former Infuse patient who claim she that died after suffocating from severe throat and neck swelling caused by the device (see Clinica No 1329, p 17).