December 21, 2012 — The medical device company Medtronic is facing a lawsuit filed by a Virginian man who suffered permanent nerve damage in his spine after being treated with Medtronic’s Infuse Bone Graft.
The lawsuit was filed in the U.S. District Court for the Western District of Virginia. The plaintiff, Scott Wadley, alleges that Medtronic minimized the risks of the Infuse, including the risk of permanent injuries, nerve damage, and chronic pain.
Since the Infuse was introduced to the U.S. market in 2002, sales have exceeded $700 million per year. Shortly after it was approved to treat Degenerative Disc Disease, more than 80% of its use was “off-label,” or for uses not approved by the FDA. The FDA eventually had to issue warnings against using it in certain “off-label” procedures (such as in the neck) due to the risk of life-threatening neck swelling.
Wadley was treated with the Infuse Bone Graft in 2003 after he underwent lumbar fusion surgery — an “off-label” use for Infuse. Infuse is a bio-engineered growth protein that is used after spinal surgery. Unfortunately, when it is used in posterior lumbar surgery, it is associated with a high risk of bone overgrowth. Wadley alleges that Infuse caused excessive bone growth, which pinched a nerve in his spine and caused severe, debilitating pain. He is unable to work because of chronic pain in his neck, back, legs, and foot.
Wadley joins a growing litigation against Medtronic at both the state and federal level. Many of these lawsuits cite articles that Medtronic sponsored and then published in the The Spine Journal. These articles omitted side effect information, including the risk of excessive bone growth.
According to The Wall Street Journal, Medtronic also paid large sums of money to doctors who produced favorable articles. The company allegedly paid $800,000 to Dr. Timothy Kuklo, an orthopedic surgeon at Walter Reed Army Hospital. He submitted an article to a medical journal with forged signatures for four non-existent “co-authors.” The study also contained fabricated data.