Many have experienced aching, cramping, respiratory problems, and even uncontrollable bone growth after receiving INFUSE® bone grafts. If you or a loved one has experienced these issues, you may be entitled to substantial compensation. INFUSE® bone grafts were approved by the FDA for use in lower spinal fusion surgeries. False advertising and other factors lead to off-label uses of the product, resulting in severe injuries. Even when used for intended purposes, patients suffered negative side effects. The manufacturer, Medtronic, has been under fire from the FDA and even the U.S. Department of Justice (DOJ) in recent years. Filing an INFUSE® bone graft lawsuit requires the legal guidance Roger “Rocky” Walton, in Arlington, TX, provides. Contact our office today to discuss taking legal action.
INFUSE® bone grafts were approved by the FDA in 2002 for spinal fusion procedures in the lower back. Two years later, its indications were expanded to include tibia repairs. In 2007, the FDA expanded on this further to include sinus augmentations in dental procedures. The bone grafts use synthetic bone materials, as well as cow collagen. The synthetic bone powder is dissolved in water, which the sponge then soaks up. The sponge is inserted into metallic cages, which are then placed between the bones in the spine to create improved stability. Over time, the bone material is released and the sponge dissolves.
False advertising and other factors lead to off-label uses of the product, resulting in severe injuries.
Unfortunately, there are a large number of catastrophic side effects associated with INFUSE® bone grafts. In fact, Medtronic is accused of paying off doctors and surgeons to hide these side effects. Patients who have received one of these bone grafts have reported side effects including:
Additionally, severe complications are also likely with off-label uses of the grafts. These include extreme swelling of the neck and throat, making it difficult to breathe or swallow. Patients required immediate respiratory support that may include intubation, medications, or a tracheotomy.
Medtronic’s promotion of off-label uses led to two whistleblower lawsuits and an investigation by the U.S. Department of Justice. Medtronic settled these suits in 2006 for $40 million. In 2012, Medtronic paid out an $85 million settlement to its shareholders for the reduced stock prices resulting from the DOJ’s investigation.
Hundreds of injured patients have also begun filing claims against the manufacturer. While these cases have not been consolidated for multidistrict litigation (MDL), and a class action suit has not been filed, the expectation of additional lawsuits may lead to an MDL. Lawsuits against Medtronic allege the company manufactured a defective product, concealed dangerous side effects, falsely marketed the product as safe, among other offenses. Many patients are also seeking punitive damages against the company for its willful and intentional actions.
Medtronic has already faced several high-profile lawsuits for its actions, and will likely face many more. It is critical to work with an attorney who has experience in defective device litigation. Roger “Rocky” Walton can build a strong case to hold the manufacturer liable and fight for your right to compensation. With his help, you can recover damages for your medical expenses, physical and emotional trauma, loss of income, and compromised quality of life.
If you or a loved one has suffered a severe injury caused by an INFUSE® Bone Graft, contact our law firm to reserve your free consultation. Mr. Walton can review the details of your injury to determine if you have a case.