The medical device company, Medtronic, is under heavy criticism along with some doctors who have been tied to using the company's product. In particular, a spine surgery device known as Infuse has taken a heavy hit for its unpublished problems, and the doctors who have continued to use it are taking just as much flack as the Medtronic company itself.
Now under investigation by the U.S. Senate Committee, officials at Medtronic were warned not to destroy, hide or make inaccessible any of the documents and / or data it held in conjunction with its Infuse product. Two well-known and powerful members of the Senate Finance Committee signed the letter advising Medtronic of this information. In addition, the official letter mandated that a comprehensive list of documents including financial records and communications between the company and the doctors themselves, all who received millions in royalties and other payments from Medtronic over the past decade, be provided without fail.
Particularly troubling to the Senate committee members is the fact that official reports suggest that the doctors involved in conducting the clinical trials of examination for the Infuse product were aware of its high potential to cause medical complications. However, the safety and effectiveness of the product failed to be reported in any medical literature. Considering the ties that some clinical investigators have to Medtronic, the issue has been further compounded, as it is speculated that foul play may have been at hand.
Infuse is formally known as bone morphogenetic protein-2, which is a powerful biological agent used by many surgeons conducting spinal fusion surgery. The product is designed to stimulate bone growth while eliminating the need to harvest a small amount of any patient's own bone in order to create a fusion between two vertebrae. Unfortunately, some medical professionals appear to have taken advantage of this medical device, as researchers are believed to have operated under a conflict of interest. Serious and unreported complications with the device have been reported, as has extensive off-label use of the product.
Medtronic is now under investigation by the U.S. Department of Justice, facing allegations of off-label marketing for Infuse. Reports estimate that approximately 85% of Infuse usage was off-label. Perhaps more disturbing is the fact that accumulating evidence suggests that superior clinical results reported by doctors with financial ties to Medtronic have not been duplicated by those doctors who have never received any payments from Medtronic. As such, it would certainly appear that a conflict of interest was at play when issuing reports and status updates concerning Infuse and Medtronic.
At The Sumner Law Group, a personal injury attorney in Kansas City, MO can help you take on a case of
medical malpractice and
product liablility such as the one described above. Here, we focus on maintaining the safety of our clients and protecting those who have already been wrongfully harmed in any way. That being said, you can reliably turn to our firm for the help you need in addressing a case of product liability injury, medical negligence injury or anything else. Currently, our firm is investigating INFUSE® Bone Graft and the LT-CAGE® Lumbar Tapered Fusion Device, used in combination to treat degenerative disc disease, and we are ready to take on your case. We can help you file a product liability lawsuit against Medtronic, should you feel you have a valid claim and would like to take legal action. Do not hesitate to
contact a Kansas City personal injury lawyer at our office today to learn more about how we may be able to help you recover from a medical injury that was unduly caused to you.