Walkup, Melodia, Kelly & Schoenberger Files Defective INFUSE Bone Graft Lawsuit Against Medtronic
Defective Medtronic INFUSE Bone Graft Lawsuit
Walkup Represents Former Surgeon with Debilitating Injuries
The Food and Drug Administration, which regulates medical devices, never approved the Medtronic INFUSE Bone Graft for use in any other type of spinal surgery except for anterior lumbar interbody fusion (ALIF) in the lower back. ALIF is a procedure where the surgeon approaches the spine through an incision in the abdomen.
Earlier testing of alternative surgical uses showed the potential for serious harm. In 1999, a Medtronic-sponsored clinical trial testing the INFUSE Bone Graft in another kind of surgery - posterior lumbar interbody fusion - indicated that bone was forming in the wrong places. After only 34 patients underwent surgery (hundreds of patients were originally slated for the trial), adverse side effects began surfacing, and the trial was halted.
Millions of People Suffer Back Pain
Millions of Americans suffer back pain from degenerative disc disease and other problems. Medtronic's INFUSE Bone Graft works to strengthen the lower spine by fusing two adjacent vertebrae.
That's the only spinal application it was approved by the FDA to do.
However, the large market for treating back pain led Medtronic to promote significant "off-label" use of its product for bone grafting - uses other than for ALIF surgery in the lower back.
Off-label Use in Roughly 85 Percent of Cases
Off-label, unapproved use of medical devices is known under the law as misbranding, and it's estimated that Medtronic reaped $700-900 million per year in sales of the INFUSE Bone Graft through aggressive promotion and engaging in illegal sales practices.
By 2007, the Medtronic INFUSE Bone Graft was used in 40 percent of the type of back surgeries for which it was never approved. This significant off-label use was a disaster for patients, causing a range of consequences, from spinal immobility and nerve damage to death.
In fact, an unbiased peer-reviewed journal indicated complication rates of the Medtronic INFUSE Bone Graft to be 10 to 50 times greater than the original estimates provided by Medtronic's paid doctors, many of whom were sent on lavish trips and received kickbacks to promote the defective medical device.
Here's what it boils down to: Medtronic didn't warn anyone of the risks. Neither did the doctors on Medtronic's kickback payroll.
Medtronic's Failure to Warn Ends a Surgeon's Career
Thousands of patients have been injured as a result of off-label and promotion of the Medtronic INFUSE Bone Graft, which Medtronic continued to aggressively market despite the red flags.
Here are the legal issues at hand:
- Manufacturing defect
- Failure to warn
- Failure to recall
- Fraud from concealing the risks
Walkup, Melodia, Kelly & Schoenberger has filed one of its first lawsuits against Medtronic for its defective INFUSE Bone Graft medical device, on behalf of a vascular surgeon who can no longer practice medicine after she underwent a type of back surgery for which INFUSE was never approved.
She is now in constant pain. Moreover, she only had a chance to be a vascular surgeon for a handful of years - less than the time it took her to complete her medical training.
Because of Medtronic's conduct, our client has a life-changing injury that could have been prevented.
Contact Us
If you have any questions about the Medtronic INFUSE Bone Graft medical device, contact the attorneys of Walkup, Melodia, Kelly & Schoenberger at (888) 799-3968.
