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A Pennsylvania man has filed a medical malpractice lawsuit after he experienced complications following a spinal fusion surgery where Medtronic Infuse BMP was used as an alternative to a traditional bone graft.
Medtronic Infuse is a bioengineered bone growth stimulant, known as a bone morphogenetic protein (BMP), which was introduced in 2002 and has been aggressively promoted by the manufacturer as an alternative to bone grafts that require bone to be harvested from another part of the body or from cadavers.
Although the FDA only approved Infuse BMP for use during spinal fusion surgery that involves a single level, anterior lumbar fusion, it has been widely used off-label for other types of spine surgery.
Lawsuit Alleges Product Liability and Medical Malpractice Claims
The complaint (PDF) was filed by Norman Kornitzer in the U.S. District Court for New Jersey on November 14, alleging that the design of the Medtronic Infuse bone graft device and a lack of proper medical care by the surgeon caused him to experience permanent injuries following a surgery two years ago.
Kronitzer indicates that he underwent a spinal fusion surgery on November 14, 2010, which was performed by Dr. Louis Quartararo at the New Jersey Spine Institute. During the procedure, Dr. Quartararo used Medtronic’s Infuse bone graft device to stimulate bone growth in the spine and promote fusion of the vertebrae.
A number of individuals throughout the United States have filed similar lawsuits over Medtronic Infuse BMP use during spinal fusion surgery, which has been linked to a risk of inflammation, nerve damage and other complications.
In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties.
According to allegations raised in product liability lawsuits filed against Medtronic in courts throughout the United States, the manufacturer failed to warn about the risk of excessive bone growth following use of Infuse BMP, which may be more likely when the device is used off-label. The growth of excess bone around the spine may result in permanent nerve damage and other problems following spinal fusion surgery.
Complaints also allege the manufacturer actively encouraged use of the Medtronic Infuse bone graft during procedures that were not only unapproved, but that the device maker knew or should have known posed an increased risk of serious injury or death.
Kornitzer’s spinal fusion malpractice lawsuit includes allegations of negligence against his doctor and the New Jersey Spine Institute, claiming that they failed to follow the appropriate standards of medical care. The lawsuit seeks compensatory damages, punitive damages, as well as legal fees.