Medtronic sued for alleged off-label promotion of bone graft medical device
NEW ORLEANS - A New Orleans man has filed a lawsuit that claims he will never recover from a spinal surgery due to the use of a surgically implanted medical device that is used to stimulate bone growth.
Claiming that the medical device was illegally promoted for off-label use, Martin Z. Gavin filed suit against Medtronic Inc., Medtronic USA Inc., and Medtronic Sofamor Danek USA Inc. on March 30 in federal court in New Orleans.
Gavin underwent a spinal transforaminal lumbar interbody fusion (TLIF) surgery to cure his chronic back pain on Feb. 7, 2011. The surgeon used a combination of Gavin's own bone fragments and Medtronic's Infuse Bone Graft.
Infuse Bone Graft is a surgically implanted medical device containing a genetically engineered protein designed to stimulate bone growth.
The device is only FDA approved for a single spinal fusion surgical procedure.
Gavin claims that his spinal fusion surgery caused his pain to worsen and necessitated an additional surgery for placement of another medical device.
The defendants are accused of providing millions of dollars in undisclosed payments to doctors for the off-label promotion of the device for other surgical procedures, including the TLIF procedure that plaintiff Gavin underwent.
The defendants are also accused of concealing and continuing to conceal their knowledge of Infuse Bone Graft's "unreasonably dangerous" risks and side effects from patients and the medical community. Specifically, the defendants are accused of concealing the increased risk of developing cancer, bone overgrowth, nerve damage, respiratory depression, and death associated with the off-label use.
Gavin argues that the illegal-off label promotion has provided Medtronic billions of dollars in sales.
Causes of action filed against Medtronic include inadequate warning, strict liability, breach of express warranty, breach of warranty of fitness for ordinary use, breach of implied warranty of merchantability and fitness, negligence and violations of federal regulation.
The plaintiff is asking for an award of compensatory damages for medical expenses, permanent physical and emotional pain and suffering, economic losses, interest, court costs, and attorney's fees.
Gavin is represented by Stephen B. Murrary, Arthur M. Murrary, Jessica W. Hayes and Robin M. Primeau of Murrary Law Firm in New Orleans. A jury trial is requested.
U.S. District Judge Nannette Jolivette Brown is assigned to the case.
Case No. 2:12-cv-00851