Marketing of Infuse Bone Graft Questioned: Is Medtronic Money Swaying Surgeons?
September 15th, 2008 laurie
Medtronic’s deep pockets are putting the medical device company under scrutiny once again, this time with a congressional investigation and a federal lawsuit alleging that at least eight Minnesota doctors are accepting kickbacks from Medtronic. The lawsuit, filed last year in U.S. District Court in Massachusetts, accuses the paid doctors of overusing Infuse, a bone graft protein made by Medtronic. The concern is that doctors paid by Medtronic will be more likely to pursue surgery than continued medical therapy for back pain and will be inclined to use Medtronic products even if cheaper or better alternatives exist.
The federal lawsuit alleges that Medtronic-funded doctors were lobbying their colleagues to use Infuse in ways that weren’t approved by the U.S. Food and Drug Administration. The doctors allegedly promoted Infuse through off-label studies, promotional efforts at professional meetings and instruction provided at a clinic in Memphis.
At least one “off-label” use resulted in a public health warning in July. The FDA reported 38 complications during the past four years resulting from the unapproved use of Infuse in cervical spine fusions near the neck. (The FDA only approved Infuse for certain fusions of the lower spine.) Some of those patients needed emergency care after receiving Infuse and suffering swelling in their necks and throats that made it difficult to breathe, according to the FDA.
