A Portland, Ore., couple has filed an Infuse bone graft lawsuit against the makers of the Infuse Spinal Fusion System, alleging the device caused serious complications, including debilitating, painful bone growth that caused pain throughout the husband’s lower body.

Plaintiff Matthew Paulsen had spinal surgery with the Infuse Bone Graft System in March 2009. According to this Infuse bone graft lawsuit, Paulsen had a small spinal disc bulge. Discs are cylinders of connective tissue that support the bones of the spine. If they are damaged, surgeons can fuse two adjacent bones to strengthen the back overall as a way of compensating for the weakness.

Usually, redundant bone from elsewhere in the body is used to encourage the bones to grow together. The Infuse Spinal Fusion System is designed to bypass this step by using a bio-engineered gel in the place of bone from elsewhere in the patient’s body. However, Infuse bone graft lawsuits like the Paulsens’ allege that the device is more dangerous than older-style spinal fusions.

Gradually, Paulsen began to experience pain throughout his lower body. By October 2010, his physicians had discovered abnormal bone growth was causing him pain. In March 2011, a little less than two years after his initial spinal fusion, Paulsen had a revision surgery — a surgery designed to repair a previous failed surgery. Paulsen’s Infuse bone graft lawsuit characterized the revision as “painful.”

The Paulsen Infuse bone graft lawsuit alleges that the device caused abnormal bone growth and pain. Further, the lawsuit alleges that the makers of the device were aware, or reasonable should have been aware, of the serious risks associated with Infuse. But a major argument of the Infuse bone graft lawsuit is that the makers of Infuse promoted the device for off-label use.

Under U.S. law, a drug or medical device must undergo rigorous testing before a company may market it. The FDA demands testing for both safety and efficacy. Sometimes, new research may proceed quicker than the slow and steady FDA approval process, showing new uses for an existing drug or medical device. Under these circumstances, a physician may make a judgment call, and prescribe a drug or device “off-label.” However, medical companies are forbidden from promoting off-label usage. The Paulsen Infuse bone graft lawsuit alleges that the device’s makers aggressively promoted Infuse for off-label uses.

The Paulsen Infuse bone graft lawsuit alleges that Medtronic, the makers of Infuse, embarked on an aggressive campaign to promote the Infuse Spinal Fusion System. The Infuse bone graft lawsuit alleged that Infuse hired “opinion leaders” to promote the device for off-label use through unofficial channels. These opinion leaders tended to be physicians with strong reputations, who publish a high number of research papers, work at large, high-volume hospitals, and have high-level consulting positions. These physicians were positioned to promote off-label use of Infuse, and published research papers without disclosing that Medtronic had paid them. The Infuse lawsuit alleges that Medtronic went as far as to ghost-write scientific papers to promote off-label use.

Other Medtronic lawsuits have alleged that the drug has caused the following complications:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Death

The Infuse Bone Graft Lawsuit is titled Matthew D. Paulsen, et al. v. Medtronic Inc., et al., Case No. 3:13-cv-2109, in the U.S. District Court for the District of Oregon.