Minneapolis-based Medtronic faces approximately 700 lawsuits involving 1,000 patients claiming personal injury due to the company's Infuse bone graft product, according to the company's SEC filing for the quarter ended Jan. 24, 2014.
Infuse is an implantable device that uses a biological agent to stimulate bone growth to treat degenerative disc disease of the spine.
Infuse has been implanted in more than 1 million patients, but approximately 85 percent of the time it was used off-label, according to a Milwaukee Journal Sentinel report.
Nashville-based Vanderbilt University orthopedic surgeon Dan Spengler, MD, said in the report many of the patients likely experienced excess bone growth following an off-label surgery.
Medtronic spokeswoman Cindy Resman said in the report Medtronic will "vigorously defend [Infuse] in court."
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