Q. What is the Medtronic Infuse bone graft?
A. The Medtronic Infuse bone graft is a medical device used to treat degenerative disc disease and in some cases, dental disorders. The Infuse bone graft uses a genetically engineered protein to fuse damaged vertebrae and help build bone tissue.
Q. When a procedure is referred to as “off-label,” what does that mean?
A. Use of a medical device for purposes not specified in the labeling approved by the Food and Drug Administration (FDA) is often referred to as off-label use. It is not uncommon for medical practitioners to use a device for off-label purposes; however, medical device manufacturers cannot advertise or promote off-label use of a product. The FDA has only approved the Infuse bone graft for use in the lower region of the spine, but since being introduced in 2002, the device has been used in hundreds of off-label procedures, including cervical spine procedures.
Q. What are some of the complications that can arise with the off-label use of a Medtronic Infuse bone graft?
A. In 2008, the FDA issued a warning that use of the bone graft in areas like the neck or upper back could cause serious complications, such as nerve damage, paralysis, difficulty swallowing, uncontrolled bone growth, unwanted bone growth, male sterility, and inflammatory cyst formation.
Q. Who is responsible for my Infuse bone graft related complication?
A. If you have suffered a serious complication as a result of having an Infuse bone graft implanted in the neck or upper back, you may be able to take legal action against Medtronic. Allegedly, Medtronic promoted off-label use of the device and even paid a doctor to fabricate a study showing positive results for off-label use of the bone graft. Large corporations have a duty to provide consumers with safe products. Corporations like Medtronic who put profits over safety may be financially liable for the expenses associated with an injury caused by the use of their product.
Q. When should I talk to a lawyer?
A. You should consult a Medtronic Infuse bone graft lawyer at Estey Bomberger as soon as possible. We are currently investigating Medtronic Infuse bone graft cases and can quickly tell you if you are eligible to file a claim. If you are able to proceed with the claims process, we may also be able to tell you what types of damages you can recover. We have helped our clients recover funds for numerous types of damages, including medical care costs, lost earnings, and pain and suffering.