A lawsuit filed this week alleges that Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product.
The complaint includes the names of 98 plaintiffs who allege that the off-label use of Medtronic caused them to incur serious and permanent damages. Off-label use refers to applying a product in ways not formally approved by the U.S. Food and Drug Administration (FDA).
Medtronic introduced Infuse as a solution to the problem of pain and other complications associated with the treatment of degenerative disc disease. The company did so by positioning the product as a means of eliminating the need for additional surgery to harvest bone from a patient’s hip for transplantation to the spine.
The Infuse Bone Graft includes a bone-growth solution contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2) soaked into an absorbable collagen sponge designed to dissipate. The solution-soaked sponge goes inside the LT-Cage, which is designed to stabilize the spine during fusion.
The U.S. Food and Drug Administration (FDA) approved Medtronic’s Infuse in 2002 for one use only: spinal surgery on the lower back in which the surgeon enters the patient through the front. Despite this, the agency was receiving alarming news about the use of Infuse on the upper, or cervical, spine; in response, the FDA sent out a July 1, 2008, notification to highlight that Infuse was not approved for use on the upper spine. The notification warned that, when used in cervical spinal fusions, the Infuse Bone Graft had been associated with serious complications – including:
- Excessive swelling in the neck;
- Compressed airways;
- Difficulty breathing;
- Problems swallowing; and
- Nerve damage.
The Complaint further alleges that, in order to tap expand the potential of Infuse in the face of the FDA approval’s limitations, Medtronic “devised a well-financed and extensive scheme to promote and market Infuse for non-approved, off-label uses,” that would make use of “fraudulent pretenses, representations and concealments of material facts.”
The Medtronic lawsuit was filed by Parker Waichman LLP, Lanier Law Firm, based in Houston, Texas; Neblett, Beard & Arsenault, in Alexandria, La.; The Drakulich Firm, APLC, in San Diego, Cal.; and Holland, Groves, Schneller & Stolze LLO, in St. Louis, Mo.