Norton Hospital is located in Louisville, Kentucky and serves thousands of Kentucky residents every year. Medtronic is a large medical device company located in Fridley, Minnesota. What these two companies have in common is a medical malpractice lawsuit that has been filed against them.
A Louisville, Kentucky woman had surgery on her spine in 2006 at Norton Hospital. The hospital used a product from Medtronic called Infuse. Infuse is a bone-graft device used in certain spinal surgeries. A liquid bone protein is put on a sponge in a little crate between vertebrae. The liquid then solidifies into bone. The patient was having spine surgery, but not the type that Infuse has been approved for by the Food and Drug Administration (FDA). Surgeons at the hospital used it in her procedure anyway.
Unfortunately, as has been the situation in other cases, the bone continued to grow into her nerves, causing damage that has resulted in debilitating pain. She now has to stay in bed for extended periods of time and has trouble doing simple everyday tasks.
When a product is promoted and used in a way that has not been approved by the FDA, it is called "off-label" use, since what the medical professional is using it for would not actually be printed on the label of the medication or medical device. Oftentimes, medical professionals successfully use off-label treatments with the patient's consent. Other times it may lead to a dangerous treatment. However, companies such as Medtronic are not allowed to promote the product for off-label use. They can be fined millions of dollars if it is determined that this illegal activity has occurred. Unfortunately, to a multi-billion dollar company that could make billions on off-label use of one drug, the risk of investigation and fines may seem worthwhile. The off-label marketing can occur in many ways, including providing the product free to hospitals and medical offices or giving price breaks on other products to medical professionals that use a certain product off-label.
The Louisville woman's lawsuit contends that neither she nor her husband consented to the hospital using Infuse off-label during her surgery and that Medtronic aggressively marketed the off-label use of the product. While a federal investigation into Medtronic regarding Infuse has been closed, that does not mean this case is over. Several civil lawsuits have been filed against Medtronic for this product and the Kentucky personal injury attorney handling this case says they have spoken to many people who have been affected by this product that may be interested in joining the lawsuit.
If you suffer from a condition caused by off-label use by a medical professional without your consent, please contact a Kentucky medical malpractice attorney to discuss your situation. The law firm of Miller & Falkner specializes in personal injury matters including medical malpractice, car accident injuries, nursing home abuse, product recalls, and premises liability cases.
Govt. closes investigation of Medtronic over bone graft product; Minnesota Public Radio; Martin Moylan; May 16, 2012
Norton Hospital, Medtronic sued over spinal surgery; The Courier-Journal; Laura Ungar; May 10, 2012