Noble A, Brennan T A, Hyams A L
Department of Health Policy & Management, Harvard School of Public Health, Boston, MA 02115, USA.
J Eval Clin Pract. 1998 Feb;4(1):49-62. doi: 10.1046/j.1365-2753.1998.t01-1-00005.x.
Medical practice guidelines are playing an increasingly important role in both the medical and the legal context. As tools for the health practitioner, it is thought that medical practice guidelines may contribute to an increase in the quality of patient care and cost-effectiveness. In the legal setting, guidelines may improve the functioning of the medical malpractice system by creating more rational, predictable standards of care. The development and promulgation of medical practice guidelines, while increasing, are still evolving. A number of concerns, especially in the areas of physician autonomy, physician control, and ethics, as well as efficacy, need to be resolved. The use of such guidelines as the legal standard of care in malpractice cases evokes similar concerns, along with fears that the use of guidelines at trial may either lower the standard of care, or, conversely, raise the standard of care to levels that are difficult to meet. Adding to this controversy is the recent case of Snyder v. American Association of Blood Banks (1996), in which the New Jersey Supreme Court upheld a jury finding that the American Association of Blood Banks (AABB) was liable to a plaintiff who contracted AIDS from an HIV-tainted transfusion, for negligent failure to adopt guidelines requiring blood testing for surrogate markers. This opinion is significant as the first to find a duty of care running from a medical guideline promulgator to a third person, the injured patient. The opinion is examined in depth and within the context of other relevant case law. The impact the opinion will have is difficult to gauge. The somewhat unique facts of the case, as well as the court's unusually stinging critique of the defendant, AABB, and its motivations informing its response to the concerns about blood contamination, may limit its value as precedent. However, precedent does exist in analogous non-medical cases for promulgator liability. The pros and cons of promulgator liability are weighed. While closer regulation of guideline development and promulgation or promulgator immunity may be warranted, it is premature to consider either seriously until the impact of the Snyder opinion can be appreciated.
医学实践指南在医学和法律领域都发挥着越来越重要的作用。作为健康从业者的工具，人们认为医学实践指南可能有助于提高患者护理质量和成本效益。在法律环境中，指南可以通过制定更合理、可预测的护理标准来改善医疗事故责任制度的运作。医学实践指南的制定和发布虽在增加，但仍在不断发展。一些问题，特别是在医生自主权、医生控制权、伦理以及有效性等领域，需要得到解决。在医疗事故案件中使用此类指南作为护理的法律标准引发了类似的担忧，同时人们担心在审判中使用指南可能会降低护理标准，或者相反，将护理标准提高到难以达到的水平。雪上加霜的是最近的斯奈德诉美国血库协会案（1996年），新泽西州最高法院维持了陪审团的裁决，认定美国血库协会（AABB）对一名因接受受艾滋病毒污染的输血而感染艾滋病的原告负有责任，原因是该协会疏忽地未采用要求对替代标志物进行血液检测的指南。这一判决意义重大，因为它首次认定医疗指南发布者对第三方即受伤害患者负有护理责任。本文将在其他相关判例法的背景下深入审视这一判决。该判决的影响难以估量。该案件有些独特的事实，以及法院对被告AABB及其对血液污染问题回应动机的异常严厉批评，可能会限制其作为先例的价值。然而，在类似的非医疗案件中确实存在发布者责任的先例。本文权衡了发布者责任的利弊。虽然可能有必要对指南的制定和发布进行更严格的监管或给予发布者豁免权，但在能够评估斯奈德案判决的影响之前，认真考虑这两者都为时过早。
