Louisiana Man Files Medtronic Infuse Lawsuit Following Off-Label Spine SurgeryMay 8, 2012 | Parker Waichman LLP
disease The lawsuit, filed in U.S. District Court for the Eastern District of Louisiana, alleges the use of Infuse in a transforaminal lumber interbody fusion resulted in painful, unwanted bone growth along the plaintiff's spine.
As we've reported previously, it's thought that roughly 85% of the producers that have involved Infuse are off-label uses. In July 2008, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar bone growth products had caused serious, sometimes life threatening complications, when used in off-label in spinal procedures. 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.
The plaintiff named in the Louisiana complaint received Infuse in February 2011. Following the procedure, the plaintiff claims he was led to believe his back pain following his initial surgery was the result of the underlying medical condition that necessitated surgery. In early 2012, however, he learned that Medtronic Infuse has been associated with unwanted bone growth, which can lead to nerve impingement.
The lawsuit alleges that because of his Medtronic Infuse operation, the plaintiff has required epidural spinal injections, physical therapy and the need for additional surgery to implant a transcutaneous electrical nerve stimulator (TENS) unit to ease his pain.