The Food and Drug Administration (FDA) has exerted regulatory control over medical devices since 1976 when the Medical Device Amendments to the Food, Drug and Cosmetic Act were signed into law. These amendments set up a system where devices were divided into three classes and seven categories. The classes are based on the amount of risk involved in the use of that product while the categories are defined as pre-market, post-market, substantially equivalent, implant, custom, investigational, and transitional. The amount of review that a device must undergo is determined by its class and category.

The focus of most litigation has been in the Class III, substantially equivalent category. A Class III medical device is defined as a device which demonstrates a potentially unreasonable risk of harm. "Substantially equivalent" means that a device was in use or existence prior to 1976 and is substantially equivalent to the device to be marketed today. The rationale is that if it has a history of safe use then there is less need for stringent testing for the new device. Unfortunately, companies often try to push through "substantially equivalent" devices which have real differences to their predecessor, all in order to avoid the rigors of the approval process. Of course not all litigation has been in this class and category.

Over the last several decades, litigation involving medical devices has included such products as Medtronic’s Pacemaker Polyurethane-Insulated leads, TMJ Jaw Implants, breast implants and most recently Sulzer Hip Implants.

How is a medical device claim determined?

Do I need a lawyer if I believe I may have a drug or medical device claim?