A lawsuit has been filed against Medtronic, Inc. on behalf of numerous patients who allege product liability, fraud, and injuries that include catastrophic, unchecked bone growth in the spinal column following surgical procedures with InFuse.
Court documents allege product liability and fraud over Medtronic’s 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. 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. Infuse is not approved for use on the upper (cervical) spine though it has been widely used in such procedures.
The limited approval also limited InFuse marketing and sales—companies 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.
In 2002 Medtronic published a Fact Sheet promoting the results of Medtronic-sponsored scientific studies. According to court document allegations, Medtronic intentionally concealed critical safety information in the Fact Sheet. Studies touted as “outside objective reports” were written or rewritten by Medtronic’s own agents. Court documents allege that Medtronic was actively involved in the writing and editing of the articles and decisions to include/exclude critical health and safety information; and that the company intentionally 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, including swelling, dysphagia (difficulty swallowing), and dysphonia (voice disorders), according to court documents.
Medtronic allegedly concealed critical safety information. Authors of a peer-reviewed article published in The Spine Journal estimated adverse events and increased risks to be as much as 50 times higher than Medtronic reported. The original Medtronic-sponsored studies, when reviewed by independent experts, confirmed that InFuse did not provide additional benefits to patients 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.
According to a 2012 report from the U.S. Senate Finance Committee, Medtronic paid approximately $210 million to Medtronic “key opinion leaders” who improperly promoted the sale of off-label InFuse. Court documents allege that the illegal kickbacks were disguised as royalties. Medtronic sponsored meetings targeted toward physicians, and involved presentations and training in off-label uses given by Medtronic-paid surgeons.
Documentation in the lawsuit alleges that Medtronic knew that off-label InFuse use was unreasonably dangerous and exposed patients to serious risks of increased injury and harm. Medtronic earned several billion dollars due to the false, deceptive, and illegal InFuse marketing scheme.