December 10, 2012 – A medical malpractice lawsuit has been filed on behalf of a Pennsylvania man who allegedly experienced severe side effects after undergoing a spinal fusion procedure where the Medtronic Infuse BMP was used as an alternative to a traditional bone graft. The complaint alleges that the design of the Medtronic Infuse, as well as a lack of proper medical care by the surgeon, caused the plaintiff to suffer permanent injuries following the surgery. The new claim is the latest in a growing number of similar lawsuits filed in courthouses around the country alleging that the Infuse caused plaintiffs severe inflammation, nerve damage, and other adverse health complications.
What’s the problem?
According to the complaint, which was filed last month in the U.S. District for New Jersey, plaintiff Norman Kornitzer underwent spinal fusion surgery in November 2010, which was performed by Dr. Louis Quartararo at the New Jersey Spine Institute. Quartararo used the Medtronic Infuse bone morphogenetic protein (BMP) to stimulate bone growth in the spine and promote fusion of the vertebrae. Two years after the surgery, Kornitzer allegedly experienced severe injuries that he will never be able to fully recover from.
First approved by the U.S. Food & Drug Administration (FDA) in 2002, the Medtronic Infuse BMP is a bioengineered bone growth stimulant that has been aggressively marketed as a revolutionary alternative to bone grafts, which require bone to be harvested from cadavers or other parts of the body. Although the Infuse has only been approved for use in spinal fusion surgery that involves a single level, anterior lumbar fusion, it has been widely used in an off-label capacity (for which it has been neither tested nor approved) for other types of spinal surgery.
In 2008, the FDA issued an urgent safety alert advising doctors not to use the Infuse in upper spinal fusion surgeries. The administration issued the alert after receiving a large number of adverse event reports (AERS) involving deaths and other serious complications that resulted from swelling of the neck and other breathing difficulties.
Medtronic Infuse bone graft lawsuits contend that the manufacturer failed to warn about the risk of excessive bone growth following the implantation of the BMP, which may be more likely when the device is used off-label. Excessive bone growth of the spine has been linked to permanent nerve damage and other adverse health complications following spinal fusion surgery. Complaints also allege that Medtronic Inc. actively encouraged the use of Infuse for unapproved purposes that pose an increased risk of serious injury or death.
Kornitzer’s Medtronic Infuse bone graft lawsuit includes allegations of negligence against Dr. Quartararo and the New Jersey Spine Institute, claiming that they failed to follow appropriate guidelines for medical care. The complaint seeks compensatory damages, punitive damages, as well as legal fees.