A couple has filed an Infuse lawsuit against Medtronic, the maker of the Infuse Bone Graft spinal fusion system. Plaintiffs Patrick and Christine McClellan allege Patrick McClellan suffered serious complications from the device.

The Infuse Spinal Fusion System is a medical device that is designed to be implanted in a patient’s spine. The Infuse device is designed to treat spinal disc degeneration. A healthy human spine is supported by discs, cylinders of connective tissue that act as cushions to support backbones. However, under some circumstances, discs can begin to fall apart and weaken, causing pain and even nerve damage. One way to treat this is to fuse adjacent vertebrae (individual backbones) into a single piece of bone. The Infuse system is designed to fuse vertebrae using a combination of a metal support cage and a gel made partly from the patient’s own body.

Patrick McClellan underwent spinal fusion with the Infuse device in August 2005. The Infuse lawsuit alleges that the off-label of use of the device was actively promoted by Medtronic. Patrick McClellan, according to the Medtronic Infuse lawsuit, began to suffer from serious complications starting in 2006. The alleged complications are painful and disabling.

When the U.S. Food and Drug Administration approves a drug or medical device, it is typically only to treat a specific condition under specific situations. For example, the Infuse Spinal Fusion System is only approved for the fusion of the lumbar vertebrae (the bones of the lower back between the ribcage and the pelvis). Any other use is considered an off-label.

Off-label uses are situations in which a physician prescribes a drug or a medical device for purposes other than the FDA-approved use. This is allowed under U.S. law. Sometimes a physician may make the call to use a device for an off-label purpose when preliminary evidence supports it. However, it is illegal for medical companies to promote off-label usage. It has been alleged that Medtronic aggressively marketed the Infuse device for off-label uses, including the surgery at the core of the McClellans’ Infuse lawsuit.

The McClellans’ Infuse bone graft lawsuit alleges that Medtronic employed paid marketers called “Key Opinion Leaders,” who helped market the device to physicians. Patients who were implanted with the device for off-label uses have allegedly suffered serious problems, including cancer, the overgrowth of bone, and nerve damage. The McClellans’ Infuse lawsuit alleges that he suffered nerve injuries, bone overgrowth, and other permanent damage related to his surgeons’ use of the Infuse device.

The Medtronic Infuse lawsuit is formally titled Patrick McClellan, et al. v. Medtronic Inc., et al, Case No. 6:14-cv-462, in the U.S. District Court for the District of Oregon, Eugene Division.