Off-Label Medtronic Infuse Procedure Left Teacher Permanently DisabledMar 19, 2012 | Parker Waichman LLP
Some patients who have received Medtronic Inc.'s Infuse bone graft product have suffered serious, life-threatening complications following off-label use of the bone growth protein. Side effects linked to off-label use of Infuse include incapacitating swelling in the throat that has caused permanent injury in some patients.
That's what apparently happened to Laurie DeNeui, a 46-year-old ex-teacher from North Dakota. DeNeui underwent a neck surgery in 2005 to treat whiplash-related headaches. During that surgery, her doctor implanted Infuse into her neck, a use that has not been approved by the U.S. Food & Drug Administration (FDA). She alleges that she was not made aware that Infuse hadn't been approved for that type of surgery, and would not have undergone the procedure had she been.
According to an article recently published in the Minneapolis Star-Tribune, DeNeui now has difficulty speaking, swallowing and breathing, a feeling she likens to having "a jawbreaker in my throat. No doctor has been able to help her, and it's unlikely DeNeui will be able to teach again, thanks to her disability.
The FDA approved Infuse, which is made with a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), 2002 for use in one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries. However, it's thought that roughly 85% of the producers that have involved Infuse are off-label uses. In July 2008, the FDA warned that Infuse and similar bone growth products had caused serious, sometimes life threatening complications, when used in off-label in spinal procedures.
Since 2008, Medtronic has been named in investigations being conducted by a U.S. Senate Committee, the U.S. Justice Department, and the state of California. At issue is whether or not Medtronic illegal promoted Infuse for use in procedures for which it was never approved. While doctors are free to use approved medical devices in anyway they see fit, it is illegal for device makers to promote those uses.