December 21, 2012 — A man from Virginia has filed a lawsuit against Medtronic, the maker of the Infuse Bone Graft, after he suffered debilitating complications. The complaint was filed by Scott Wadley in the U.S. District Court for the Eastern District of Virginia. He alleges that Medtronic did not adequately warn about the risk of Infuse side effects, including permanent nerve damage.
According to the complaint, Wadley was implanted with the Infuse in January 2003 after undergoing a lumbar fusion surgery. Shortly afterward, he alleges that the bone growth protein caused excessive bone growth in his spine. The overgrown vertebrae impinged a nerve in his spine. He now suffers from chronic pain in his neck, back, legs, and foot.
The Medtronic Infuse is a bio-engineered growth protein that is intended to help repair bones following spinal surgery. Infuse is not approved for use in posterior lumbar surgery. When it is used “off-label,” there is a higher risk of excessive bone growth, which can pinch nerves in the spine. This is an excruciatingly painful complication that can cause permanent disability and decreased quality of life.
Many lawsuits have been filed against Medtronic on behalf of people who were injured by the Infuse. Wadley’s complaint cites articles published in The Spine Journal, which were sponsored by Medtronic and have been widely criticized for inaccurately reporting the safety of the Infuse, omitting side effect information (including excessive bone growth), and minimizing the risks associated with the Infuse.
The company has also been criticized for allegedly paying doctors thousands of dollars to promote the Infuse. For example, the Wall Street Journal reported that Medtronic paid $800,000 to Dr. Timothy Kuklo, an orthopedic surgeon at Walter Reed Army Hospital, who submitted an article to a medical journal with fabricated claims about the efficacy of the Infuse and forged signatures of four “co-authors.”