Engineering and the law-the wages of sin: preventing punitive damages

The author discusses the common themes in several recent cases holding medical device manufacturers liable for punitive damages. He points out that current medical device design and manufacturing standards prevent clearly dangerous products from staying in the marketplace, creating the legal expectation that devices should be risk-free. A court that expects devices to be risk-free may misunderstand the inevitable adverse product reports that accompany rigorous product testing. Therefore, device manufacturers must anticipate and manage these misunderstandings during product development if they are to appear credible before the court. A framework for a preventive law plan to minimize the risk of punitive damage awards is presented.<>