Medtronic’s Bone Growth Device Subject to Widening Criminal Probe

The Justice Department is widening its criminal probe into the marketing practices of Medtronic, Inc. in relation to its spinal fusion device Infuse, according to a published report in the NY Times. The criminal probe could prove to be a financial burden for Medtronic since Infuse accounts for a majority of biologic product sales.
The Infuse investigation is not new. In 2008, a 2008 Army report found that Dr. Timothy R. Kuklo had overstated the benefits of Infuse. Kuklo who became a Medtronic consultant, had forged the signatures of co-authors on an Infuse study that had been submitted to a medical journal. That same year, the FDA issues a warning about such devices as Infuse, citing the potential for life-threatening injuries when Infuse and similar products are used to treat neck pain.
Most recently, the FDA denied Medtronic’s application for approval concerning a high-strength version of Infuse known as Amplify. The FDA found that clinical studies of Amplify raised questions about a higher rate of cancers associated with the use of the new bone fusion device.