Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product – despite the fact that federal health officials have warned against such uses. That is the key charge levied in a lawsuit filed this week at the 22nd Circuit Court in St. Louis, Missouri.
The plaintiffs – the complaint names 98 of them – allege the off-label use of Medtronic caused them to incur serious and permanent damage to their health. Off-label use refers to use of a product in ways not 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 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 Complaint refers to the June 2011 issue of The Spine Journal, which was entirely devoted to Medtronic – the first time in the publication’s history that it devoted itself to one topic – disclosed that Medtronic-paid researchers had failed to report serious potential complications stemming from use of Infuse bone graft; in addition, Medtronic paid these researchers hundreds of millions of dollars, something not disclosed to the public until much later.
The Infuse Bone Graft includes a bone-growth solution that 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 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, and difficulty breathing.
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.