A Minnesota man filed an Infuse bone graft lawsuit against the makers of the medical implant, Medtronic Inc., alleging that the Infuse Bone Graft System is both dangerous and illegally over-promoted.

Plaintiff Michael Ashby had the Infuse bone graft implanted in the bones of his neck by surgeons. This is an “off-label” use of the device, meaning that it was for a purpose other than the device’s U.S. Food and Drug Administration (FDA) approval, the Infuse bone graft lawsuit claims.

While it is legal for doctors to make a decision to use a medical device or drug for an off-label purpose, it is illegal for the manufacturer to promote off-label use, which can complicate their position in medical device lawsuits.

According to the text of Ashby’s Infuse lawsuit, he suffered from bone overgrowth, which has led to nerve compression and damage, which could cause lifelong medical problems.

The Infuse Bone Graft System is a medical implant designed to join two vertebrae together. This procedure, called a spinal fusion, is typically used to strengthen a diseased or damaged vertebrae.

In older-style spinal fusions, redundant bone from elsewhere in the patient’s body is harvested and used to encourage the separate bones to grow together. The Infuse Bone Graft System was designed to save a step, by using bioengineered gel in the place of harvested bone.

However, Medtronic only submitted the Infuse Bone Graft System for approval for a specific type of spinal fusion in the lower back.

According to federal law, a medical company must submit their products for approval for each separate use of their drug before marketing and promoting it for use.

Ashby’s Infuse lawsuit alleges that the decision to use Infuse, and his subsequent complications stemmed from Medtronic’s decision to promote the device for off-label use.

According to this Infuse bone graft lawsuit, Medtronic organized a campaign of a semi-clandestine promotion dating back to 2002 at least.

Medtronic allegedly hired “thought leaders” and “opinion leaders,” medical professionals with sufficient clout, to promote the device on their own and influence medical opinions.

Allegedly, this went as far as having ghostwritten research papers promoting the device for off-label usage and concealing complications. This included prominent spinal surgeons, including at least one at Walter Reed Army Medical Hospital.

Ashby’s Medtronic lawsuit claims that these papers influenced his surgeons’ decisions to use the device in this manner.

The Infuse Bone Graft Lawsuit is Michael Ashby v. Medtronic Inc., et al., Case No. 0:14-cv-03211-DWF-FLN, in the U.S. District Court for the Central District of California.