What is Off-Label Use?
When a drug or medical device is used in a way that is different than the FDA approved way, it is said to be off-label. Pharmaceutical companies cannot promote their medication or medical devices for other purposes without the FDA approval. In the case of Infuse, it has been promoted and marketed in ways it was not approved for.
The U.S. Food and Drug Administration (FDA) only approved the use of Infuse for lower spinal surgeries to promote bone growth, but Medtronic has recently been caught promoting the off-label use of Infuse to healthcare providers for other types of procedures. For this reason and due to reports of deaths, illnesses and injuries, the FDA has issued an announcement warning the public about serious health complications linked to the off-label use of Infuse Bone Graft.
Additionally, the U.S. Department of Justice is investigating the off-label use of Bone Morphogenetic Protein (BMP) spinal implants, such as Infuse. Even Medtronic has announced, in a legal settlement, that its sales representatives have promoted the off-label use of the BMP spinal implant against FDA regulations.
If the Off-Label Use of Infuse Bone Graft Caused You to Suffer
There are now Infuse lawsuits being investigated and brought against Medtronic for the serious side effects, injuries and fatalities this harmful product caused patients who received the Infuse Bone Graft during their procedures. If you have suffered health complications due to the off-label use of Infuse, you should talk with a Medtronic infuse lawyer to find out your rights to a financial recovery.
Call Gray & White for help seeking justice and the compensation you deserve. You can reach our skilled Kentucky Infuse lawyers at (800) 634-8767 or (502) 210-8942 for a free, no-obligation consultation today.