Medical Devices

We've represented hundreds of individuals injured by defective medical devices.

MR. STEVEN KNOWLTON: Medical devices are defined in the United States, and regulated by the Food and Drug Administration of the United States. A medical device is considered to be any device that is utilized in the treatment of disease in either seeking a cure or seeking palliation of disease, or even in the replacement of body parts. Some of the more usual medical devices that we think of, and some that have become very popular in recent years are joint replacements, for example. It's not uncommon for folks who are in their 50s and 60s who are active in their younger years to require joint replacements, especially knees and shoulders. These things are regulated by FDA as well as other cosmetic implants such as, for example, breast implants. Other devices that are considered to be medical devices are heart stents, defibrillators, pacemakers and all of their assorted pieces, and they're also all regulated by FDA. FDA has three classes of medical devices. And for the purposes of my talk today, the one that we most frequently deal with are Class three devices. These devices are most highly regulated by FDA, and these, again, would be defibrillators, cosmetic implants and joint implants of that nature. The law confers responsibility on device manufacturers to make sure that along with the requirements of the FDA the devices they manufacturer and sell are safe and effective. The types of injuries that some patients experience related to defective medical devices is generally dependent upon the device itself, and in which part of the body it's implanted. For example, if you received a defective knee implant, you would experience pain and disability in your knee, usually a lack of motion or diminishment of the range of motion. And then upon x-ray and diagnostic procedures, the orthopedic surgeon likely, in this case, would be able to identify that there was either a fracture or some other defect or problem with the device that was causing you to have the adverse symptoms.