Doctors Prescribing Medical Devices for Uanpproved Uses?

Beth Janicek
Attorney
(866) 735-1102 Ext 395
Posted by Beth JanicekOctober 07, 2008 4:39 PM

Pharmaceutical and medical device companies should develop high-quality, innovative products which assist Doctors in providing the best possible care for their patients. Instead it seems there are some companies using kickbacks such as money and trips to entice Doctors to prescribe their products—even if the product is not approved for a particular use. One such company is Medtronic, the world’s largest device maker, which has attracted the attention of two Senators, Charles Grassley, R-Iowa and Herb Kohl, D-Wis., who have asked Medtronic to provide details about physicians who receive company payments for consulting services. In attempt to prevent, or at least expose, such unethical practices, Sen. Grassley and Sen. Kohl have written a bill which would require companies to disclose all payments to physicians over $500.

This isn’t the first time Medtronic has been questioned about their physician-payment practices. In 2006 they reached a $40 million settlement with the U.S. Department of justices to settles charges that Medtronic paid doctors millions in kickbacks to use its spinal repair products. As a part of the settlement, the government agreed to seek dismissal of two law suits brought by former employees.

A recent Wall Street Journal Law Blog discussed one of these law suits, which includes such allegations that Medtronic sales staff took physicians to strip clubs and picked up the tab. The problem is even greater because there is widespread off-label use of Medtronic Infuse, a bone graft device, and some believe these non-approved uses stem from doctors who received kickbacks. This situation worsens because serious complications have been reported, and the Food and Drug Administration has warned doctors that using Infuse for off-label procedures, such as neck surgeries, has led to problems swallowing, breathing, and speaking which in some cases required additional surgery.

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