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.