Medtronic InFuse draws patient lawsuit
This article was originally published in The Gray Sheet
Executive Summary
Maker of the recombinant human bone morphogenetic protein product denies promoting an off-label neck implant that allegedly caused the death of a California woman last August. In a suit filed Dec. 2 in Los Angeles federal court, the family of Shirley Nisbet charges that Medtronic improperly promoted InFuse, which is only approved for the lower spine and certain dental and tibial fracture indications. The surgery followed a July 1 FDA warning against off-label use of the bone growth product in the cervical spine due to the potential for life-threatening complications (1"The Gray Sheet" July 7, 2008, p. 10). Medtronic recently received a subpoena from the Department of Justice seeking information on off-label use of InFuse (2"The Gray Sheet" Nov. 24, 2008, p. 20). The inquiry follows the September initiation of a U.S. Senate investigation into allegations that the firm provided incentives to physicians for use and promotion of spine products, including off-label InFuse. The allegations stem from a 2002 lawsuit over alleged spine product kickbacks, which was settled by Medtronic in 2006 for $40 million without any admission of wrongdoing (3"The Gray Sheet" Oct. 6, 2008, In Brief)