Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC
...ATLANTA Dec. 3 /- A patient who was surgically implanted... The Complaint alleges among other things that Medtronic improper... The Nisbet family is grieving the loss of Mrs. Nisbet a beloved ... The FDA has received more than 200 reports of significant side eff...
Date:12/3/2008
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.
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SOURCE James A. Dunlap Jr. & Associates LLC; Page Perry, LLC Copyright©2008 PR Newswire. All rights reserved | |
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