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Infuse Bone Graft Lawsuit Says Medtronic Concealed Off-Label Risks

Medtronic is the defendant in yet another Infuse bone graft lawsuit filed by a patient who alleges severe complications, physical pain and suffering and financial losses after having the product implanted in an off-label surgery. The personal injury/products liability claim was originally filed by the plaintiff, Katherine Roden, in Kentucky state court, but was removed to U.S. District Court for the Western District of Kentucky based on jurisdiction of diversity.

The Infuse bone graft surgery was indicated for the plaintiff, who suffered from scoliosis, degenerative disc disease and spinal foraminal stenosis, by her physician who performed a direct lateral interbody fusion using a minimally invasive approach. According to allegations raised in the suit, Medtronic failed to disclose the dangers associated with unapproved or off-label Infuse usage during her spinal fusion surgery, and continued to misrepresent and conceal adverse event reports from the medical community. As a result of these acts and omissions, Roden claims to have suffered permanent and debilitating complications post-operatively that continue to persist to this day.

Facts and allegations cited in Infuse bone graft lawsuit

In her lawsuit, the plaintiff states that her surgery included several experimental uses of the Infuse bone grafting product without the supporting LT-cage and allograft material (from a bone bank). Roden further alleges that to the best of her knowledge, a member of the Medtronic sales team was present in the operating room at the time of her spinal fusion procedure, which was performed on March 31, 2009. The surgery involved “precise off-label uses, including but not limited to without all component parts,” states the claimant. Her surgery took place in Norton Hospital, located in Louisville, Kentucky.

By reporting flawless, or near perfect outcomes in its off-label spinal fusion surgeries in its original sponsored studies, the plaintiff argues that Medtronic likely promoted widespread use of its product for unapproved uses such as her own. In reality, new adverse event reports cited in The Spine Journal tell an entirely different story, with a 25 to 50 percent risk of Infuse bone graft problems noted in posterior lumbar body fusion procedures. Medtronic is being accused of underreporting and/or failing to report grave side effects linked to off-label Infuse operations, which often have catastrophic consequences for the patient.

The 2011 Spine Journal report stated that unlike the majority of Medtronic-sponsored clinical trials, their research found that life-threatening adverse events including infection, implant displacement, ectopic bone formation and osteolysis were as much as 40 percent higher with the rhBMP-2 fusion procedure. Such adverse events with the product are the sole reason why the FDA failed to approve Infuse for certain spinal fusion surgeries, states the lawsuit.

Medtronic was later found to have paid kickbacks totaling $210 million to the authors of their Infuse bone graft studies, from 1996 through 2010.

Off-label Infuse surgery performed by Medtronic-funded surgeon

In addition to Medtronic, Roden is also suing Norton Hospital for her alleged injuries and complications. The complaint contends that following her 2009 surgery, Roden had an excruciating recovery period marked by extreme pain and the need for an additional surgery.

Among the complications alleged are ectopic bone growth, severe nerve impingement and damage. She is seeking compensatory damages for past, present and future medical costs, lost wages, emotional trauma, diminished earnings capacity and pain and suffering. Her Infuse bone graft lawsuit is also demanding punitive damages for the defendants’ purported reckless and malicious conduct that placed company profits over consumer safety.

Infuse off-label uses account for up to 95 percent of all product sales, which have earned billions of dollars for Medtronic.