ATLANTA, Dec. 3 /PRNewswire/ -- A patient who was surgically implanted with Medtronic's Infuse(R) Bone Graft product, for an off-label use promoted by Medtronic, suffocated due to severe throat and neck swelling, according to James A. Dunlap Jr. & Associates LLC and Page Perry, LLC who filed the lawsuit in California along with another national law firm.
The Complaint alleges, among other things, that Medtronic improperly promoted its Infuse(R) Bone Graft product for a cervical lumbar surgery procedure, when the product was not approved by the Food and Drug Administration for that use. Infuse(R) Bone Graft product may cause severe swelling in the neck and throat that restricts breathing and can lead to suffocation of the patient if used off-label for unapproved uses, particularly spinal surgery performed from the back.
"The Nisbet family is grieving the loss of Mrs. Nisbet, a beloved wife and mother," said James A. Dunlap, one of the attorneys representing the Nisbet family. "Because of Medtronic's wrongful conduct, many other patients like Shirley Nisbet may have improperly received Medtronic's Infuse(R) Bone Graft product for an off-label use," Mr. Dunlap added.
The FDA has received more than 200 reports of significant side effects resulting from off-label use of the medical device, particularly in the cervical spine, a number of which have led to serious and potentially life- threatening complications. According to the FDA, complications typically occur within two to 14 days after the implant surgery. Some individuals required insertion of feeding tubes, tracheotomies, anti-inflammatory drugs and additional surgery to drain the implant site. Data presented at a recent spine conference reflected a 59 percent complication rate in cervical spinal surgeries using Infuse(R). The study was conducted by a group of North Carolina surgeons between July 2005 and December 2007 and involved 76 patients.
Medtronic's Infuse(R) Bone Graft product has been the subject of a recent whistleblower lawsuit brought by former Medtronic employees who alleged that doctors received over $8 million in 2006 in "sham" consulting fees for using and promoting the Infuse(R) Bone Graft product. Medtronic's marketing and promotion of the device for off-label uses is being investigated by the United States Department of Justice. In addition, the United States Senate is conducting hearings into the matter. Medtronic previously settled for $40 million with the Justice Department on another whistleblower action alleging that, between 1998 and 2003, Medtronic's spinal products division paid kickbacks to doctors in a number of forms, including sham consulting agreements, sham royalty agreements and lavish trips to desirable locations.
The case is "Walter Nisbet et al. v. Medtronic, Inc. and Medtronic Safamor Danek USA, Inc., United States District Court, Central District of California, Case No. SACV08-1361-JVS (RNBx)."
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