Medical device maker Medtronic has been accused of paying physicans kickbacks — again. In 2006, Medtronic paid the U.S. Department of Justice $40 million to settle allegations that it had paid physicians to use its spinal repair products. Last month, the Wall Street Journal reported that Medtronic allegedly entertained surgeons at a strip club, sent them on fully paid trips to Alaska, and awarded some royalties on inventions they had no part in developing — all as inducements to support off-label use of Medtronic spine products. (David Armstrong, “Lawsuit Says Medtronic Gave Doctors Array of Perks,” Sept. 25, 2008.) Weeks earlier, the Journal also reported serious complications in patients who received the same off-label use of Medtronic’s “Infuse Bone Graft” device.
Recommended Action: Medtronic’s recurring problems should serve as a reminder for healthcare providers about the value of exercising caution in accepting benefits from drug and device makers. Providers need to balance the value of supporting promising, innovative drugs and devices that benefit patients, on one side, against the risks of accepting enticements that create appearances of impropriety on the other. Providers who accepted payments and benefits from Medtronic have paid a heavy price not only by having been linked to this story but also by having been named as defendants in and forced to defend several “whistleblower” lawsuits filed against Medtronic. Moreover, providers risk liability if problems ensue from the off-label use of Infuse. Ultimately, providers need to protect themselves by investigating further.
Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels healthcare providers on regulatory compliance and business matters. For additional information, please contact him at harry@fentonnelson.com
©Harry Nelson 2008
California Healthcare Law 