A Medtronic Infuse bone graft complications lawsuit alleges that a South Carolina man suffered debilitating injuries after the device was implanted at the base of his neck.

Plaintiff Wesley Jordan of South Carolina states that he had the device implanted in his neck in 2010, based on medical literature that said the device could work for off-label purposes like neck surgery. Soon after the surgery, Jordan’s Infuse lawsuit alleges that Jordan suffered serious, debilitating pain due to bone overgrowth and nerve problems stemming from the Infuse Bone Graft System.

The Infuse Bone Graft System is a spinal implant built by Medtronic Inc. The Infuse is a device designed to streamline spinal fusion surgery. Spinal fusion surgery is a type a back surgery designed to strengthen the spine in the event of disc degeneration. Traditional spinal fusion surgery works by using redundant bone harvested from elsewhere in the body to encourage bones of the spine to grow together. Infuse works by using a bioengineered gel in the place of harvested bone. However, it is alleged that that Infuse Bone Graft System can cause serious Infuse bone graft complications and that Medtronic illegally over-promoted the device.

Jordan’s Infuse lawsuit holds that clinical trials of the Infuse Bone Graft System revealed that use of the device should have been stopped because patients were experiencing uncontrolled bony overgrowth, meaning bone tissue kept growing even after the spine was fused. This bony overgrowth was particularly dangerous because the spine contains critical nerves that control and regulate the body, and bone overgrowth could threaten them, causing pain, numbness, paralysis and other nerve problems.

This Infuse lawsuit also alleges that Medtronic illegally promoted the Infuse bone graft. The makers of medical implants like the Infuse Bone Graft System are legally obligated to test their devices and submit them to the U.S. Food and Drug Administration for approval. This process is designed to ensure that medical devices like the Infuse are both safe and effective.

But sometimes, medical science progresses faster than the FDA approval process. This is why surgeons are allowed to use medical devices “off-label,” outside of the FDA approval process, if there is medical literature to support such use. However, medical companies like Medtronic Inc. are forbidden from promoting a device for off-label use, an allegation made in Jordan’s Infuse lawsuit.

According to this Infuse lawsuit, Medtronic used several channels to illegally promote Infuse for off-label use. This included hiring “opinion leaders,” prominent spinal surgeons to covertly promote the device. Allegedly, Medtronic paid physicians to publish fraudulent research papers to promote the Infuse Bone Graft System for off-label use.

The Infuse Lawsuit is Wesley Jordan v. Medtronic Inc., et al., Case No. 4918, in the U.S. District Court for the Central District of California.