Medtronic, which manufactures the Infuse Bone Graft device, has been ordered to pay $392 million to Edwards Lifesciences Corp. for infringing on the company’s patent. Medtronic’s CoreValve heart device is sold outside the U.S., but Edwards plans to ask the judge to prevent Medtronic from selling it in the U.S. after a judge ruled the device infringes on Edwards’ patent.
Medtronic faces additional legal trouble, as the Infuse Bone Graft device has come under fire for potentially severe side effects. The company allegedly promoted the Infuse for off-label surgery in the upper spine, though it has only been approved for use in the lower spine.
When the Infuse device is inserted through unapproved methods, patients can experience severe side effects. Infuse Bone Graft side effects include excessive bone growth, airway compression, retrograde ejaculation and sterility in males.