Louisville, Ky.-based Norton Hospital and medical device company Medtronic, based in Minneapolis, are facing a lawsuit from a Louisville woman who said she suffered "disabling complications" following a spinal surgery at Norton Hospital in 2006 that involved Medtronic's Infuse bone graft device, according to a Courier-Journal report.
Crystal Stevens alleged she is permanently disabled from the surgery, as she must recline most of the time and depends on her husband for simple tasks such as tying her shoes, according to the report.
Brett Oppenheimer, attorney for Ms. Stevens, said the Infuse bone graft was implanted in an "off-label" and unpermitted surgery, according to the report. Infuse is FDA-approved but only for a specific spine surgery performed through the abdomen, which is not the surgery Ms. Stevens underwent.
Medtronic officials said they do not comment on pending litigation, while Norton Healthcare officials have not yet received the complaint.
Mr. Oppenheimer said in the report he and fellow attorney David Gray plan to file several more lawsuits on behalf of patients who allege similar complications from procedures that used Infuse devices.
Crystal Stevens alleged she is permanently disabled from the surgery, as she must recline most of the time and depends on her husband for simple tasks such as tying her shoes, according to the report.
Brett Oppenheimer, attorney for Ms. Stevens, said the Infuse bone graft was implanted in an "off-label" and unpermitted surgery, according to the report. Infuse is FDA-approved but only for a specific spine surgery performed through the abdomen, which is not the surgery Ms. Stevens underwent.
Medtronic officials said they do not comment on pending litigation, while Norton Healthcare officials have not yet received the complaint.
Mr. Oppenheimer said in the report he and fellow attorney David Gray plan to file several more lawsuits on behalf of patients who allege similar complications from procedures that used Infuse devices.
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