ATLANTA, Dec. 3 A patient who was surgically implantedwith Medtronic's Infuse(R) Bone Graft product, for an off-label use promotedby Medtronic, suffocated due to severe throat and neck swelling, according toJames A. Dunlap Jr. & Associates LLC and Page Perry, LLC who filed the lawsuitin California along with another national law firm.
The Complaint alleges, among other things, that Medtronic improperlypromoted its Infuse(R) Bone Graft product for a cervical lumbar surgeryprocedure, when the product was not approved by the Food and DrugAdministration for that use. Infuse(R) Bone Graft product may cause severeswelling in the neck and throat that restricts breathing and can lead tosuffocation of the patient if used off-label for unapproved uses, particularlyspinal surgery performed from the back.
"The Nisbet family is grieving the loss of Mrs. Nisbet, a beloved wife andmother," said James A. Dunlap, one of the attorneys representing the Nisbetfamily. "Because of Medtronic's wrongful conduct, many other patients likeShirley Nisbet may have improperly received Medtronic's Infuse(R) Bone Graftproduct for an off-label use," Mr. Dunlap added.
The FDA has received more than 200 reports of significant side effectsresulting from off-label use of the medical device, particularly in thecervical spine, a number of which have led to serious and potentially life-threatening complications. According to the FDA, complications typically occurwithin two to 14 days after the implant surgery. Some individuals requiredinsertion of feeding tubes, tracheotomies, anti-inflammatory drugs andadditional surgery to drain the implant site. Data presented at a recent spineconference reflected a 59 percent complication rate in cervical spinalsurgeries using Infuse(R). The study was conducted by a group of NorthCarolina surgeons between July 2005 and December 2007 and involved 76patients.
Medtronic's Infuse(R) Bone Graft product has been the subject of a recentwhistleblower lawsuit brought by former Medtronic employees who alleged thatdoctors received over $8 million in 2006 in "sham" consulting fees for usingand promoting the Infuse(R) Bone Graft product. Medtronic's marketing andpromotion of the device for off-label uses is being investigated by the UnitedStates Department of Justice. In addition, the United States Senate isconducting hearings into the matter. Medtronic previously settled for $40million with the Justice Department on another whistleblower action allegingthat, between 1998 and 2003, Medtronic's spinal products division paidkickbacks to doctors in a number of forms, including sham consultingagreements, sham royalty agreements and lavish trips to desirable locations.
The case is "Walter Nisbet et al. v. Medtronic, Inc. and Medtronic SafamorDanek USA, Inc., United States District Court, Central District of California,Case No. SACV08-1361-JVS (RNBx)."
For additional information contact James A. Dunlap Jr. & Associates LLC at404-354-2363, http://www.jamesdunlaplaw.com, or Page Perry, LLC, at770-673-0047, http://www.pageperry.com.
SOURCE James A. Dunlap Jr. & Associates LLC; Page Perry, LLC