A Infuse bone graft lawsuit filed in June has joined the swelling ranks of lawsuits against Medtronic Inc. over one of the Infuse Bone Graft System.

In this Infuse lawsuit, plaintiff Donnie Keller alleges that he suffered serious complications from the Infuse Bone Graft System.

In 2006 and 2012, Keller had two separate spinal fusions with the Infuse Bone Graft System. Based on medical publications, his surgeons used the device for a so called “off-label” use, or in a manner not approved by the U.S. Food and Drug Administration (FDA).

As Keller recovered from his spinal fusion, he suffered increasing pain and other problems which were eventually traced to uncontrolled bone growth, allegedly caused by the Infuse Bone Graft System.

The Infuse Bone Graft System is a medical implant designed to streamline a type of spinal surgery called a spinal fusion. A spinal fusion is a procedure wherein surgeons join two adjacent vertebrae (backbones) together to strengthen the spine. This procedure is most often used when a patient suffers from a degenerated disc — a condition where the connective discs that support the spine wear out from illness, age, or injury.

In a normal spinal fusion, surgeons use bone harvested from elsewhere in the body to help fuse the bones together. The Infuse Bone Graft System uses a bioengineered gel to encourage the bones to grow together without harvesting bone. However, Infuse lawsuits allege that the device is dangerous, and that Medtronic illegally marketed the device beyond its FDA approval.

According to this Infuse lawsuit, studies dating back to 1999 found that the Infuse Bone Graft System could cause uncontrolled bone growth. A 1999 clinical trial on Infuse was actually halted because several patients experienced uncontrolled bone growth. In these cases, bone grew beyond the spinal fusion, and began to injure and put pressure on vital nerves in the spine, causing serious problems.

The Infuse lawsuit further alleges that not only was the Infuse bone graft dangerous, but that Medtronic illegally promoted the device beyond FDA guidelines. Under federal law, a medical device must be subjected to FDA testing before it may enter the market.

The FDA protocols call for specific testing for safety and efficacy. Additionally, the FDA’s approval is very specific — a medical company like Medtronic must test its device for every purpose they intend to market the device.

In the case of the Infuse Bone Graft System, the device was only approved for a very specific sub-type of spinal fusion surgery in the lower back.

Federal law does allow for exceptions to this process. If medical studies suggest that a device could work in purposes beyond its FDA approval, surgeons may use their discretion. But companies like Medtronic are expressly forbidden from promoting such uses without FDA approval.

Keller’s Infuse lawsuit holds that Medtronic engaged in a clandestine campaign of promotion for off-label uses for the Infuse Bone Graft System.

According to this Infuse lawsuit, Medtronic covertly promoted Infuse by hiring “opinion leaders” to promote the device by proxy. This alleged process consisted of hiring prominent surgeons to write up research studies and tout the device’s benefits at medical seminars in order to promote off-label usage.

Allegedly, this included fraudulent research papers, which led Keller’s surgeons to use Infuse off-label for his spinal fusion.

The Infuse Bone Graft Lawsuit is Donnie R. Keller v. Medtronic Inc., et al., Case No. 2:14-cv-04851, in the U.S. District Court for the Central District of California.