It is interesting to note that surgeons that utilized Norian XR have not been named in the criminal indictment considering that they used the product "off label." While surgeons can use their clinical discretion to use a product off label, the government claims that Synthes violated the law by promoting the use of this product off label. This is what the prosecution will have to prove. The bigger question will be, "Was Synthes attempting to do an end around?" Let's be honest, how much of INFUSE has been used off label? Up until the anterior cervical fusion went awry, Medtronic was flying under the radar with INFUSE. Is it really only used in conjunction with their cage? Not!
The bigger question that needs to be answered is "Were the patients informed of the risk involved injecting an exothermic material into a vertebral compression fracture?" If not, how culpable and liable does the surgeon become? Is he an accessory to marketing the product off label to his patients? The funniest part of the article is when the surgeon involved in one of the deaths stated that the rep pushed the product on him. In all the years that I have sold I have never had the ability to "push" a product on a surgeon. If so, the qualifications of this surgeon must be questioned by the prosecution if this case goes to trial. The SpineBlogger wants to know what you blokes think?