Government investigating off-label use of Medtronic device
Device Regulation Alert: Safety, Compliance and Reimbursement News, November 24, 2008
The Department of Justice is looking into the off-label use of Medtronic’s Infuse Bone Graft, an implant for promoting bone growth, according to a Wall Street Journal article.
Infuse is FDA-approved for limited use in the lower lumbar region, but the FDA has received 38 reports of complications from cervical uses of Infuse in the past four years. Medtronic said it has not improperly marketed the device, according to the Journal.
Medtronic reached a settlement with one patient who filed a malpractice suit over off-label use of Infuse. The suit focused on off-label use and the relationship between a Medtronic salesman and the spinal surgeon. According to the Journal, the surgeon said in his deposition that the sales representative encouraged the off-label use of Infuse.
Three whistleblower lawsuits filed against the company include allegations of illegal marketing, including paying surgeons to use Infuse and other Medtronic spine products.
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