The liabilities and consequences of medical device development.

A large increase in medical products liability litigation during the past 40 years has resulted in a flood of litigation against drug and device manufacturers. The medical technology and chemical industries are prime targets for products liability litigation. Physicians and other health care providers are willing to accept a reasonable degree of risk associated with the use of a medical product when compared to the benefit to be achieved by that product but lay juries are less likely to tolerate the concept of an acceptable failure rate. Plaintiffs' lawyers believe that the medical products industry should be held to a standard of absolute liability and that anyone injured by a medical product is entitled to recover without regard for the circumstances. Large compensatory and punitive damage awards, the high cost of insurance, large defense costs, and low profit margins have forced some companies to remove their products from the market. The medical or biomaterials manufacturer can significantly reduce its exposure for products liability by adopting a successful product safety program. Manufacturers have significant control over the quality, safety, and reliability of their products through appropriate design, testing, manufacture, labeling, and sale of quality products.