The streaming content service Netflix recently unveiled a new documentary dealing with the potential dangers of increasingly complex medical devices that doctors prescribe to their patients. Some of these devices, the documentary highlights, can pass United States Food and Drug Administration (FDA) approval with less scrutiny than other new products. “Bleeding Edge” takes a look at the 510(k) “substantial equivalence” test in a way that provides important legal insight to a broader audience than personal injury attorneys could hope to reach. Under this less demanding process drug manufacturers can receive FDA approval for new and often times novel medical devices that bear only a tenuous relationship to products that were approved in the past. The documentary does well to point out that the 510(k) process might not be adequate to screen for the safety of new devices that use biomedical technology that is light years more advanced than older models. By examining the FDA’s medical device approval system through the lens of patient safety, “Bleeding Edge” asks an important question that plaintiff’s attorneys routinely tackle – are these products safe? While the answer to this question necessarily involves a debate about the higher costs associated with more extensive approval criteria, “Bleeding Edge” makes clear that the price of patient harm must be part of the conversation too. The attorneys at Goldstein Bender & Romanoff have successfully litigated medical device lawsuits against some of the nations largest manufacturers. Please call us immediately to discuss your legal rights if you or someone you know has been injured as the result of a medical device failure.
— Scott M. Duxbury