The learned intermediary doctrine: the case of advertising medicine and medical devices in the United States

Abstract

Purpose – The purpose of this paper is to examine a unique marketing and legal problem that manufacturers of prescription drugs and medical devices face in the USA, under the theory of “overpromotion” and the Learned Intermediary Doctrine (the LID), and suggests a solution to the problem. Design/methodology/approach – The study uses a critical review of the literature and decided legal cases to analyze the problem of direct-to-consumer advertising of prescription drugs and medical devices under the LID and “overpromotion” doctrines. Findings – The study suggests a different approach to advertising drugs that divides the audiences into primary and secondary targets to immunize drug and medical device manufacturers against liability. Research limitations/implications – Because the laws guiding advertising are different in different countries, the findings of this study are relevant only to the US market. Practical implications – The paper gives practical guidance on an alternative communication strategy that could immunize drugs and medical device manufacturers against liability. Originality/value – The study uses knowledge of law and marketing to tackle an issue that, even though is useful and relevant, is rarely discussed in the marketing literature.