Ginzburg H M
Epidemiology Branch, National Institute of Allergy and Infectious Diseases' AIDS Program.
Am J Law Med. 1986;12(3-4):423-39.
Medical epidemiology is the cornerstone for understanding the safety and efficacy of drugs and medical devices. Epidemiologic principles provide a statistical basis for determining correlations, and ultimately mathematical causation, between two series of events. Medical epidemiologic evidence and statistical inferences are useful and are now routinely accepted in the courtroom. The complex distribution systems that provide fungible goods throughout the country often preclude the identification of the specific source of an allegedly defective product. An expansion of the principles established in Summers v. Tice and Ybarra v. Spangard provide a logical and rational means for the courts to address products liability issues in cases involving multiple and unnamed defendants. This Article discusses the impact of epidemiology on the judicial process, both in the nature of judicial decision-making and in the nature of the law itself. Part III B discusses the "weak" and "strong" versions of the traditional preponderance of the evidence rule, as recast by recent products liability litigation. The remainder of the Article defines the useful and appropriate scope of epidemiologic evidence, concluding that "intentless" epidemiologic evidence alone cannot support an award of punitive damages.
医学流行病学是理解药物和医疗器械安全性与有效性的基石。流行病学原理为确定两个事件系列之间的相关性以及最终的数学因果关系提供了统计基础。医学流行病学证据和统计推断是有用的,并且现在在法庭上已被常规接受。在全国范围内提供可替代商品的复杂分销系统常常使得无法确定所谓有缺陷产品的具体来源。对在萨默斯诉蒂奇案和伊巴拉诉斯潘加德案中确立的原则进行扩展,为法院处理涉及多个未指明被告的案件中的产品责任问题提供了一种合乎逻辑且合理的方式。本文讨论了流行病学对司法程序的影响,包括司法决策的性质以及法律本身的性质。第三部分B讨论了近期产品责任诉讼重塑后的传统优势证据规则的“弱”和“强”版本。本文的其余部分界定了流行病学证据的有用且适当的范围,得出结论认为仅“无意的”流行病学证据不能支持惩罚性损害赔偿的裁决。