A group of law firms has filed a lawsuit in Circuit Court in St. Louis against Medtronic, Inc. on behalf of patients who allege injuries that include catastrophic, unchecked bone growth in the spinal column following surgical procedures with Medtronic’s bone growth product InFuse.
Court documents also allege product liability and fraud involving the InFuse Bone Graft LT-Cage Lumbar Tapered Fusion Device System. The suit was filed by Parker Waichman LLP, Neblett Beard & Arsenault, The Drakulich Firm, The Holland Law Firm, and The Lanier Law Firm.
In 2002, InFuse received limited Food and Drug Administration (FDA) approval for use in a single level fusion. Infuse is a genetically engineered, synthetic, recombinant human bone morphogenetic protein (rhBMP-2) that received FDA approval to stimulate spine growth in patients suffering from lower spinal degenerative disease; for use in one type of spinal surgery; and for use in some dental procedures. Although InFuse is not approved for use on the upper (cervical) spine, it has been widely used in that area.
The limited approval also limited InFuse marketing and sales—device makers are not allowed to promote devices for anything other than approved uses—but court documents allege Medtronic employed an illegal, false, and deceptive marketing scheme to promote the sale of InFuse for unapproved uses.
Medtronic’s marketing included a 2002 Fact Sheet promoting the results of Medtronic-sponsored scientific studies. According to court documents, Medtronic intentionally concealed critical safety information in the Fact Sheet. Studies that were claimed to be “outside objective reports” were actually written or rewritten by Medtronic’s own agents. Further, the documents allege Medtronic was actively involved in the writing and editing of the articles and in decisions to include or exclude critical health and safety information; and that intentionally Medtronic omitted and concealed information about serious adverse events revealed in the research.
As early as 2006, doctors reported adverse events associated with the off-label use of InFuse in the cervical spine. The adverse events include swelling, difficulty swallowing, and dysphonia (voice disorders), according to court documents.
According to a peer-reviewed article published in The Spine Journal, the adverse events and increased risks could be much as 50 times higher than what Medtronic reported. The original Medtronic-sponsored studies, when reviewed by independent experts, confirmed that InFuse did not provide additional benefits to patients over traditional bone grafts and exposed patients to serious and undisclosed increased risks and complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain.
A 2012 report from the U.S. Senate Finance Committee said that Medtronic paid approximately $210 million to Medtronic “key opinion leaders” who improperly promoted the sale of of InFuse for off-label use. Court documents allege that some of the illegal kickbacks were disguised as royalties. Medtronic sponsored meetings targeting surgeons, and the meetings included presentations and training in off-label uses given by Medtronic-paid surgeons.
Documentation in the lawsuit alleges that Medtronic officials knew that off-label InFuse use was unreasonably dangerous and exposed patients to serious risk of injury and complications. Medtronic reportedly earned several billion dollars through the InFuse marketing scheme.