Medtronic Inc, a medical device maker, is contesting claims that it is responsible for the death of a California woman whose doctor inserted a bone-growth protein into her neck.
According to this news report in the St. Paul Business Journal, Shirley Nisbet of Vista, California, had Medtronic’s Infuse Bone Graft inserted in her neck in August, barely weeks after the U.S. Food and Drug Administration (FDA) issued a warning that such a surgery could pose a risk to the patient’s life.
The lawsuit, filed by Nisbet’s family, alleges that she went into respiratory arrest after the procedure and died within days of the surgery. But Medtronic officials say its technical consultant had denied recommending the off-label use of the company’s Infuse Bone Graft product. Physicians ultimately decide how medical devices are used to the benefit of the patients, a Medtronic spokesperson says. To me, that sounds like passing the buck.
Apparently, this is not the first time Medtronic is placed in a position of answering questions about the unauthorized use of Infuse Bone Graft. The U.S. Department of Justice has opened an investigation into the use of this medical device, which was approved by the FDA in 2007 for regenerating facial bones.
The Wall Street Journal reported earlier this year that Medtronic’s Infuse Bone Graft, was linked to complications when it was used in surgeries on the cervical spine, located around the neck. The report said that the bone protein, which is approved for use in various spinal, oral and dental graft procedures, was linked to complications when used in ways not approved by the FDA.
I’m sure the technical details of this case will be contested in court, but a family has lost their loved one because of this defective medical product. To me, this product clearly appears defective and dangerous. I hope the Department of Justice’s investigation helps shed light on the real effects of this device on patients. If you or someone you love has suffered severe injury or death as a result of this medical device, I’d like to hear about it.