Invoking Learned Intermediary Rule in Malaysia

Abstract

In the realm of pharmaceutical liability, failure to warn or to provide sufficient information such as adverse reaction or allergies of pharmaceutical products may cause manufacturers to be liable under the traditional common law of tort for the harm or death it causes. This article shows that manufacturers of prescribed pharmaceutical products may escape such liability if information and warnings have been conveyed to physicians; a learned intermediary between the manufacturers and the patients. The learned intermediary rule acts as a defence mechanism for manufacturers of pharmaceutical products as the physician is deemed as an intervening force that breaks the chain of causation in the law of negligence. Hence, the main focus of this article is to examine whether Malaysian courts would accept such a defence if invoked by the manufacturers. The objective of the article is to analyze and identify the learned intermediary between the manufacturer of a prescribed pharmaceutical products and patients under the relevant Malaysian statutes, particularly Poison Act 1952 and Medicines (Advertisement and Sale) Act 1956. In achieving the above objective, the authors adopts historical, comparison and also critical analysis methods. The finding of this article is that, it is an offence for pharmaceutical products to be sold or supplied directly to patients and strictly requires a learned intermediary such as physician to prescribe such products. Thus, it is concluded that the defence has its merits and therefore it is unlikely patients would be able to obtain compensation if this defence is invoked.

DOI: 10.5901/mjss.2015.v6n2p428