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A wrongful death lawsuit has been filed by a California woman who went into respiratory arrest after a neck surgery that involved the use of the Medtronic Infuse bone graft. The lawsuit alleges that Medtronic is responsible for her death because they promoted the bone graft for use in the cervical spine, which was an unapproved use which has been shown to have a high rate of serious and potentially fatal complications.
The Medtronic Infuse bone graft consists of a man-made liquid bone graft that includes a bioengineered protein called bone morphogenetic protein (BMP).
The graft is used to encourage bone growth and replace damaged spinal disks by filling inter-vertebral gaps. It is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.
The bone stimulator was introduced in 2002, but the FDA has only approved for use in the lower-back and for some oral and dental procedures. Although Medtronic has never submitted data establishing that it is safe for use in other areas of the spine, the Infuse bone graft has been widely used off-label in neck fusions.
There have been over 200 reports of serious complications associated with the use of the Medtronic bone graft, particularly when it is used off-label in the cervical spine. Given the close proximity to the airway, use of the bone stimulator during neck surgery has resulted in problems such as difficulty breathing, swallowing and speaking. It can cause swelling of the neck, which may compresses the airway and the nerves, potentially resulting in death.
The wrongful death lawsuit was filed on December 2, 2008, in the United States District Court for the Central District of California in Los Angeles by the family of Shirley Nisbet. The complaint names Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. as Defendants.
Nisbet died as a result of respiratory arrest which she alleges was caused by the use of the Infuse bone graft in her neck. The lawsuit claims that a Medtronic representative encouraged the surgeon to use the Infuse bone graft in the neck surgery, and was present in the operating room during her surgery.
The FDA issued a health warning in July 2008 warning about the off-label use of bone stimulators in the cervical spine, which was several weeks before Nisbet’s surgery. The Infuse lawsuit alleges that Medtronic was well aware of the serious risk of complications associated with the use of the bone graft in the cervical spine at the time of her surgery.
Last month, Medtronic disclosed that the U.S. Department of Justice is investigating their marketing and promotion of the Infuse bone graft, as several allegations have been raised that indicate the company encouraged off-label use in the neck.
Although surgeons are permitted to use approved medical devices for un-approved uses, the manufacturer is not allowed to promote or encourage those off-label uses which they have not determined to be safe. If the Justice Department finds that Medtronic violated the federal law in their promotion of the Infuse bone graft, the medical device company could face substantial fines.
The Nisbet case is believed to be the first Medtronic Infuse bone graft lawsuit filed in the United States as a result of the use of the stimulator during neck surgery.