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Medical Devices

Medical devices have long been known to society. Everyone who has read Treasure Island realizes that the peg-leg pirate was actually the recipient of an orthopaedic prosthesis. Peg legs have been replaced by lifelike prosthesis and the ever-expanding list of medical devices now includes orthopaedic bone screws, pedicle screws, breast implants, contraceptive implants (including Norplant), penile implants and heart valves. While many medical devices are safe and effective for their intended uses, many others, including some of the above listed, are not.

Medical devices are produced by various manufacturers both large and small. Large corporations include Bristol Meyers Squibb, Dow Corning and 3M. Smaller corporations include Mentor, Acromed, and literally hundreds of others. This list is by no means all-inclusive.

Medical devices for use and sale in the United States are governed by the Food and Drug Administration (FDA). The FDA was established in 1931 but it was not until the 1976 Medical Device Amendments to the Food, Drug & Cosmetic act that the FDA was given power over medical devices. This act sought to provide "reasonable assurance of safety and effectiveness" for all devices.

Because of the complexity and diversity of medical devices, two different methods were devised by the FDA to group them. Devices are categorized into three classes ( I, II, III) based upon the amount of risk involved in the use of that device. In addition to "classes", devices are divided into seven different categories which relate to the 1976 amendment: pre-market, post-market, substantially equivalent, implant, custom, investigational, and transitional. The classes and categories determine the level of scrutiny that a device must undergo in order to reach the market.

The largest group of medical devices which have become the subject of litigation involve those devices which are class III, substantially equivalent. Class III medical devices consist of those devices which present a potentially unreasonable risk of injury. Devices are "substantially equivalent" if the FDA finds that a device which was in existence and use prior to the 1976 amendment is substantially equivalent to a device which is proposed to be marketed today. The logic is that if a device has been in use since before 1976 then similar devices need not go through rigorous testing because the device is tested by time. In theory this is true, but all to often companies will propose a device for approval as "substantially equivalent" when there truly are significant differences, simply in order to gain approval without costly and time-consuming test trials. Litigation arises more often than not in this fact pattern.

When using a medical device, it is incumbent upon the doctor to disclose to the patient the risks attached to the use of this device. Failure to give such informed consent may, in some states, give rise to a claim for malpractice against the doctor.

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This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.