Since about 2002 Surgeons have been using a Medtronic Product named Infuse. It is comprised of human recombinant bone proteins. It was designed to be used in spinal fusion surgery to stabilize the spine. Oddly enough, the FDA has actually approved Medtronic’s Infuse for a variety of applications such as open tibial fractures, degenerative disc disease and several bone grafting applications. Medtronic’s use for spinal fusion is an off label usage which in essence means that the FDA approved the drug but not for the purpose it was being used.
Doctors have learned that if the Infuse material is not properly inserted it may seep or escape and create bone growth where it was not intended and this can lead to catastrophic results. Statistics are varied but as many as 59% of the spinal fusion procedures where Medtronic’s Infuse was utilized, experienced complications. In 2008 the FDA issued a ‘warning’ regarding this off label usage.
A study at Stanford of 240 men who underwent spinal fusion (69 of the patients with the off label use of Medtronic Infuse) showed the prevalence of the problem with Infuse. Six (of the 69) of the men who used Infuse developed a condition known as retrograde injection. This condition causes semen to be delivered into the bladder, rendering the patient infertile.
Many lawsuits have been filed and there is one class action suit regarding claims for this off label usage. These types of claims are challenging and complicated. At Gibbs and Parnell, we have hundreds of years of cumulative courtroom experience in handling claims for defective products such as Infuse. Don’t trust your claim to any lawyer you find in the yellow pages or on line. Gibbs and Parnell has a Martindale Hubbell, peer reviewed AV rating, the highest rating for competence and ethics among all lawyers.
We can evaluate your claim and give you sound legal advice and handle your claim with the highest level of professionalism and competence. For claims of this nature, you need a Firm like Gibbs and Parnell who are big enough to help but small enough to care.