A Medtronic Infuse bone graft complications lawsuit filed by an Oregon woman alleges Medtronic paid medical professionals to promote its product for illegal uses.

Plaintiff Kristin Lingren received an Infuse bone graft implant to repair damage to a spinal disc in her neck in 2009. However, her recovery was difficult, as she experienced significant pain. In 2011, her surgeons read an article that suggested the device could cause uncontrolled bone growth and damage to nerves, symptoms Lingren suffered.

In Lingren’s case, the Infuse Bone Graft System was used in a manner called “off-label usage.” Off-label usage involves using a medical device for purposes other than those approved by the U.S. Food and Drug Administration (FDA). A medical company must submit a drug or medical device for approval for every use of the device it intends to promote.

Physicians are allowed to use their own judgment, particularly in cases in which the medical literature suggests a new use for a drug or medical device might be effective. However, medical companies are forbidden from promoting a device for off-label use. In the case of Infuse, Medtronic has only applied for FDA approval for a very specific type of spinal surgery in the lower back. Despite this, an estimated 80-90 percent of Infuse bone graft devices were sold for off-label use.

Lingren’s Medtronic lawsuit alleges that Medtronic hired “opinion leaders,” orthopedic surgeons and other medical professionals, to promote off-label use of the device in a clandestine scheme to encourage Infuse bone graft sales. According to this Medtronic lawsuit, opinion leaders received “handsome sums in return for publishing studies and medical journal articles which downplayed and concealed the risks of adverse events from off-label use while actively promoting off-label applications of the product.”

The alleged opinion leaders included prominent orthopedic surgeons at UCLA and Walter Reed Army Medical Hospital. One alleged opinion leader published seven articles promoting Infuse, and was paid $19 million by Medtronic between 2003 and 2007. Another alleged conspirator received $150,000 for roughly eight days of work writing a research paper promoting Infuse.

Additionally, even early Medtronic-funded studies on the Infuse bone graft suggested the medical implant could have serious medical implications, including some that Lingren allegedly suffered. A 1999 study by Medtronic was halted after only 34 trials because 70 percent of patients suffered unwanted bone growth. This required an average of two additional surgeries to correct.

Infuse is a device designed to help treat damaged discs in the lower back, by fusing two adjacent vertebrae together in spinal fusion surgery. The Infuse Bone Graft System does this by supporting the two bones with a metal cage, and using a bio-engineered gel to promote bone growth, causing the two bones to fuse together.

Lingren seeks to recoup the cost of her ongoing medical care, lost income potential, and legal fees associated with her Medtronic lawsuit.

The Infuse Lawsuit is Kristin Lingren v. Metronic Inc., et al., Case No. CV14-4857R-AJWT, in the U.S. District Court for the Central District of California.