An Alaskan man has filed a Medtronic lawsuit over the Infuse Bone Graft System. His Infuse lawsuit alleges that the medical device is dangerous and illegally-promoted by Medtronic.

The Infuse Bone Graft System is a medical implant designed to improve spinal fusions. Spinal fusions are a type of back surgery that joins two adjacent backbones together to compensate for damage to the tissues which cushion the bones of the spine.

In traditional spinal fusion surgery, redundant bone is harvested from elsewhere in the body to help the bones grow together. The Infuse bone graft is designed to bypass this step with a bioengineered gel that encourages new bone growth. However, Infuse bone graft lawsuits allege that the device is more dangerous than the older-style spinal fusions.

According to the Medtronic lawsuit, plaintiff Donald Mallozzi underwent back surgery with the Infuse Bone Graft System. Based on several articles, the physician decided to use the Infuse bone graft for an unapproved or “off-label” surgery.

In the United States, federal law requires that all medical implants undergo rigorous testing for both efficacy and safety for each stated purpose of the device. However, the law does acknowledge that sometimes, scientific discovery can outpace the U.S. Food and Drug Administration’s (FDA) approval process and allows physicians to make their own judgment call on using a device for other purposes than the FDA-approved use.

However, it is illegal for a company to promote its devices for off-label usage.

After receiving the Infuse Bone Graft, Mallozzi says he experienced increasing pain. Imaging revealed uncontrolled bone growth, which ultimately required surgical correction. His Infuse lawsuit alleges that Medtronic acted fraudulently in promoting the device, ultimately leading to his bone graft complications.

In Mallozzi’s bone graft lawsuit, he alleges that Medtronic, the makers of Infuse, aggressively promoted the device for off-label usage. This included hiring “opinion leaders” to promote the device.

More specifically, the Infuse lawsuit claims that Medtronic paid physicians and researchers on advisory committees, high publication volume, and control of large surgical centers to aggressively promote Infuse in person and through publication.

Allegedly, this promotion of the Infuse bone graft included the articles that Mallozzi’s physician consulted before recommending off-label usage in Mallozzi’s case. The allegations go even further, making the accusation that Medtronic actually hired ghost writers to promote Infuse beyond its FDA-approved purpose.

While Medtronic is facing numerous Infuse lawsuits like Mallozzi’s, they have also been under scrutiny by federal regulators, including Senate hearings, as well as investigations by medical schools and peer-reviewed journals reevaluating the evidence surrounding the use of the Infuse Bone Graft System.

Despite facing Infuse bone graft lawsuit, shareholder and whistleblower lawsuits, Medtronic has reaped more than $3.6 billion in sales from Infuse since its 2002 debut.

The Infuse Bone Graft Lawsuit is Donald Mallozzi v. Medtronic Inc., et al., Case No. 3:14-cv-00155-TMB, in the U.S. District Court for the District of California.