Authors : Fahirah Syaliza Mokhtar, Rahmah Ismail, Ahmad Munir Mohd Salleh and Zailin Zainal Ariffin
Abstract: A defective medical product directly affects patient in which they are unable to evaluate and make decision as a smart consumer, especially when faced with the use of cutting-edge, complex and sophisticated medical products. Patients who wishes to claim under Consumer Protection Act 1999, encounters many hurdles to satisfy the elements under Part X of the Consumer Protection Act 1999, particularly proving the defect itself and most demanding is proving causal relationship. Hence, the main focus of this article is to examine the challenges encountered by patients in seeking compensation for injury or death due to defective medical products in Malaysia. The objective of the article is to analyze the law of product liability, under the Malaysian Consumer Protection Act 1999, Thailand’s Medical Device Act, BE 2551 and also Germany’s Pharmaceutical Product Act 1976 aiming at improving the patient’s mechanism of compensation. The finding of this article is that, the requirement of proof under Malaysia Consumer Protection Act 1999 for defective medical products is almost impossible to fulfill. Based on the law of Thailand and Germany the analysis highlights that a legislative intervention in the form of adding a particular section in the legislation should be implemented. Thus few improvements are suggested including the amendment to the provisions contained in the Malaysian Consumer Protection Act 1999 as well as including provision of civil liability in the Malaysian Medical Device Act 2012 and Poison Act 1952 to better assists patients in claiming compensation.
Fahirah Syaliza Mokhtar, Rahmah Ismail, Ahmad Munir Mohd Salleh and Zailin Zainal Ariffin, 2016. Medical Product Liability in Malaysia: The Need of Legislative Intervention. The Social Sciences, 11: 5162-5165.