An Infuse lawsuit was filed against Medtronic Inc., alleging that the company illegally promoted a dangerous medical implant.

In July 2010, Plaintiff Robert Skoubo had a spinal fusion surgery. Spinal fusion surgery is a procedure used to strengthen the spine by joining two different backbones together.

This is usually performed due to degenerative disc disorder, a condition wherein the cushion of connective tissue between the individual bones of the spine wears out due to injure, illness or age. According to the Infuse lawsuit, Skoubo suffered uncontrolled bone growth after his surgery, which in turn caused an inflammation of his nerves, called neuritis.

Infuse lawsuits have alleged that Medtronic Inc. knew, or reasonably should have known, that the Infuse Bone Graft System is potentially dangerous. The Infuse Bone Graft System is designed to simplify the process of spinal fusion surgery.

In traditional spinal fusion surgeries, redundant bone is harvested from elsewhere in the body and used to join the bones of the spine together. Infuse uses a bio-engineered gel to replace this donor bone. However, Infuse lawsuits like this one allege that Medtronic Inc. had found in the earliest clinical trials that the Infuse Bone Graft System could encourage excessive bone growth, beyond the intended growth needed to fuse the intended bones together. Since the spine is a nexus of nerves, such bone growth may press against or damage nerves.

One accusation in many Infuse lawsuits, which is echoed in Skoubo’s Infuse lawsuit, is the accusation that Medtronic engaged in an illegal form of advertising for their drug, promoting it for “off-label” usage.

Under the law, a drug or medical device, like the Infuse Bone Graft System, is required to undergo through testing for safety and efficacy. Under U.S. Food and Drug Administration (FDA) protocols, a medical device must undergo separate testing for each intended use of the device. A medical company like Medtronic Inc. can only promote their device for the purposes they’ve gotten FDA approval for.

U.S. law recognizes that sometimes medical science can outpace the FDA’s approval process, and allows doctors to make their own decisions about treatments based on medical research. However, medical companies are forbidden from marketing drugs or implants like the Infuse Bone Graft System for off-label uses.

Skoubo’s Infuse lawsuit alleges that Medtronic Inc. engaged in a clandestine marketing campaign using “opinion leaders” to promote off-label use covertly. Per the Infuse lawsuit, this allegedly involved hiring prominent doctors to promote the device at medical conferences and workshops, as well as writing research papers singing the praises of the device for off-label surgeries without declaring conflicts of interest. According to the Infuse lawsuit, these alleged opinion leaders were typically paid millions for days or weeks of work.

The Infuse Lawsuit is Robert Skoubo, et al., v. Medtronic Inc., et al., Case No. 0451, in the U.S. District Court for the District of Oregon.