An Infuse bone graft complications lawsuit was filed by a Utah man who alleges the device is dangerous and was illegally marketed for unapproved surgeries. The Infuse lawsuit names Medtronic Inc., the makers of the device, as well as several related companies as defendants.

The Infuse Bone Graft System is a type of medical implant developed and manufactured by Medtronic Inc. The device is designed to help fuse two adjacent vertebrae together. Surgeons perform this procedure, called a spinal fusion surgery, to strengthen the spine after degenerative disc disease, a condition wherein the discs of connective tissue that support the spine weaken from age, injury or disease. However, Infuse lawsuits allege that the device is not only dangerous, but that Medtronic Inc. has encouraged surgeons to use the device for unapproved purposes.

Plaintiff Jeromy Jensen filed the Infuse lawsuit in June. He had the Infuse device implanted in his spine in September 2006 in an off-label procedure. His surgeons said that they read peer-reviewed research to support this use of the device. Jensen began to experience serious pain and other alleged Infuse side effects. His Infuse lawsuit contends that the device caused his symptoms, and that Medtronic Inc. illegally marketed the device, leading directly to Jensen’s surgery.

According to this Infuse lawsuit, Medtronic Inc. used  a clandestine campaign to encourage doctors to use the device for purposes beyond the Infuse Bone Graft System’s U.S. Food and Drug Administration (FDA) approval.

Under the law, a surgeon can exercise his or her own judgment, and use a drug or medical device outside of its FDA-approved purpose. The law allows for this because sometimes, medical research advances more quickly than FDA approval. However, a medical device manufacturer is forbidden from advertising or encouraging their wares for purposes beyond their FDA approval.

In order for a company to legally promote a medical device for new purposes, they must obtain FDA approval for such uses. Jensen’s Infuse lawsuit holds that Medtronic Inc. uses a covert system of “opinion leaders” to promote off-label use through back channels in the medical community.

One example of an opinion leader cited in the Infuse lawsuit is that of a surgeon who worked for the University of Wisconsin’s medical department. According to the Infuse lawsuit, this surgeon was paid millions by Medtronic Inc. to conduct workshops several days a year. These workshops allegedly aggressively promoted the Infuse Bone Graft System.

Additionally, the doctor in question reportedly published several research papers on the Infuse Bone Graft System, without declaring the fact that Medtronic Inc. was allegedly paying him to do so. Other opinion leaders allegedly included prominent spinal surgeons at UCLA’s Orthopedic Surgery Department and other nationally-recognized surgical centers. Allegedly, Medtronic Inc. managed to even hire military surgeons at the Walter Reed Army Medical Center to promote the drug for off-label uses.

The Infuse Lawsuit is Jeromy Jensen v. Medtronic Inc, et al., Case No. 4887, in the U.S. District Court for the Central District of California.