Articles on Law, Science, and Engineering

Public Policy and the Preemption of State Tort Claims against Medical Device Manufacturers (cont'd)

Medical Devices in Modern Medicine[index]

Medical devices are as old as human kind. From the first shaman's rattle, to the latest particle beam surgery units, medical devices are inextricably linked with medical practice. While the general public may think of breast implants as typifying medical devices, this is a false perception. The vast majority of medical devices are used for treating serious medical conditions. Typical medical devices are the narrow, nine inch long tube of Dacron that replaces a ruptured abdominal aorta, the tiny plastic valve that saves the hydrocephalic child from a lingering death, the artificial knee that allows an injured worker to play ball with his children, or the defibrillator that corrects the potentially fatal arrhythmia.

While the FDA has had the authority to regulate misbranded and adulterated medical devices since the Food and Drug Act of 1938, these powers were inadequate to keep dangerous medical devices off the market. Congress remedied this when it passed the Medical Device Amendments of 1976. These amendments gave the FDA the right to require pre-market approval (PMA) of new medical devices, the right to review the safety and efficacy of medical devices that were already on the market, and the right to require that the clinical trials necessary to apply for PMA meet the requirements for an investigational device exception (IDE). These powers were intended to improve the safety and efficacy of medical devices and to make the medical device regulations better parallel the prescription drug regulations.

The MDA is a public health law. It is intended to improve the public health and safety in three ways: First, by creating a regulatory environment that encourages innovation and fosters the development of new medical devices. Second, by assuring the safety and efficacy of new devices that come to the market. Third, by requiring that the risks and benefits of medical devices be balanced by the FDA, thus preventing local juries from denying the national public beneficial devices.

Plaintiff's lawyers see the role of the MDA as having the sole objective of reducing the risks posed by an individual device to an individual patient. This view discounts the benefits of medical devices, both to the individual patient who might be injured, and to the larger universe of patients who will not be injured by the medical device. Taken to its logical conclusion, perfect safety can only be achieved when the last medical device is priced out of the market.

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