The Impact Of Human Factors Experts In Medical Device Litigation
Human factors is “the study of the interrelationships between humans, the tools they use, and the environment in which they live and work.” Linda T. Kohn, To Err Is Human: Building A Safer Health System 63 (National Academy Press 2000) (emphasis omitted). The goal of the human factors professional is to eliminate user error through product design and labeling. See, e.g., Neal I. Muni, M.D., Challenges in Regulating Breakthrough Medical Devices, 60 Food Drug L.J. 137, 139-140 (2005). More and more frequently, human factors experts are relied upon to render opinions in product liability cases involving allegedly defective medical devices. While there are many instances where these experts are retained by defense counsel, they are most commonly used by plaintiffs to excuse user error. See, e.g., Douglas R. Richmond, Human Factors Experts in Personal Injury Litigation, 46 Ark. L. Rev. 333, 338 (1993). This is because the focus in human factors is on “correcting” the actions of the manufacturer in designing the product (rather than on the user’s negligent or even reckless conduct). See, e.g., Michael Wiklund, Defining and Designing for Worst-Case Users (July 1, 2006), available at http://www.mddionline.com/article/defining-and-designing-worst-case-users) (a medical device must “withstand the actions and inactions of unprepared, unfit or impaired users”; in order to design an “error-tolerant” medical device, the product developers should consider the “characteristics of worst-case users.”). The prevalence of human factors experts in medical device cases is due, in part, to this underlying philosophy.
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