A Virginia man has filed a product liability lawsuit that alleges a Medtronic Infuse lumbar fusion caused excess spinal bone growth, which has left him with permanent nerve damage and other problems.
The complaint (PDF) was filed by Scott Wadley on December 6, in the U.S. District Court the Eastern District of Virginia.
Wadley indicates that he was implanted with Medtronic Infuse bone graft during a posterior lumbar fusion surgery in January 2003. Due to alleged side effects of the implant, the bone growth stimulant resulted in the formation of excessive bone around the spine, which has caused nerve compression and persistent pain in his back, legs and foot.
Medtronic Infuse Excess Bone Growth Problems
Medtronic Infuse is a bioengineered bone protein, which was introduced in 2002 as an alternative to traditional bone graft surgery, where bone is harvested from another part of the body or a cadaver to encourage the fusion of spinal vertebrae. Although Infuse was only approved for lumbar fusion surgery involving an anterior approach, the product has been widely used off-label, as was the case in Wadley’s surgery.
Wadley joins a growing number of individuals throughout the United States who are pursuing a Medtronic Infuse lawsuit after experiencing similar problems following off-label use. The complaints allege that Medtronic illegally promoted Infuse for posterior lumbar fusion and other applications that were never tested or established as safe and effective. In addition, the complaints indicate that the manufacturer actively downplayed the risk of excess spinal bone growth from Medtronic Infuse.
“The actual rate of incidence of these serious side effects is much greater than the rate disclosed by Medtronic or these Medtronic-sponsored studies to physicians or to the public,” the lawsuit claims.
In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties.
The growth of excess bone around the spine following Medtronic Infuse surgery may result in permanent nerve damage and other complications.
Wadley’s lawsuit claims he is disabled due to back and leg pain, cannot be gainfully employed and has suffered severe bodily injuries and lost wages. The lawsuit accuses Medtronic of fraud, failure to warn, defective manufacturing, defective design, negligence, and breach of warranty. Wadley seeks compensatory and punitive damages.