Medical malpractice and new devices: defining an elusive standard of care

Early adoption of a new medical device by a physician carries with it some degree of malpractice liability risk. The legal standard for malpractice varies from place to place, but generally requires an evaluation of the physician's conduct either against that of a hypothetical "reasonable physician," or else against professional custom. Where the use of a new device involves a significant departure from traditional modalities of care, and a bad clinical result follows, questions may arise about whether the legal standard for malpractice has been violated. We suggest that a liberal interpretation of the malpractice standard of care is appropriate, and even necessary to avoid the potential for perverse disincentives to technical innovation in medicine.