During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various substances or gasses commonly found in operating rooms. Similarly, prolonged use may cause cables and wires to become overstressed. Such component degradation may result in unwanted changes in the robot’s movement patterns or even complete structural failure. Issues like these, if not immediately addressed during product development, can become low-hanging fruit for plaintiffs’ lawyers.
Product liability lawsuits targeting medical device manufacturers often include design defect claims. To win their case, at trial the plaintiffs must prove that certain design flaws make the product unreasonably dangerous to consumers. In Florida, for example, to do so the plaintiffs must show that the product fails to perform as safely as an ordinary consumer would expect and/or (depending on the type of product) that the risk of danger in the design outweighs the benefits. In some states, in order to prove a design defect, plaintiffs must also show the existence of a feasible, reasonable alternative design whose adoption could have reduced, or prevented, harm.
Any evidence suggesting that potential failure points were ignored or minimized during the device development cycle can exponentially increase a plaintiff’s chances of prevailing on a design defect claim. This is true even if such flaws are limited to the types of materials used in manufacturing individual components. Thus, companies should not just identify and record failure points. They should take affirmative steps to eliminate them before bringing the product to market. Otherwise, there is a chance that future company liability may significantly outweigh any competitive advantage gained by launching a product before such issues are resolved.