Malfunctioned Pacemaker and Business Operator's Liability in US, EU and Australia: Implication for Thailand

Abstract

At the present time, for the purpose of healthcare, pacemakers and other implantable medical devices are playing a significant role. However, the severity of level of damage arising from a malfunctioning pacemaker may be higher when compared with other simple products because when taking into consideration the characteristics and purpose of a pacemaker, it was normally implanted into a patient's body to control an abnormal heartbeat rate; therefore, a malfunctioned pacemaker may potentially cause harmful consequences, and in the worst scenario, death. From the abovementioned issue, the aspects of this research focused on the evolution of the laws and regulations in Thailand in relation with defective products including but not limited to Product Liability Act B.E. 2551 (2008), moreover, the medical devices control system of Thailand defined in the Medical Devices Act B.E. 2551 (2008) in comparison with the United States were examined. In addition, this research referred to the judicial decisions on a malfunctioned pacemaker in the United States, the EU and Australia, their background reasons, interpretation and implications for Thailand. This study also examined what would be the most suitable solution for a Thai Court in regard with imposing a liability to an entrepreneur and the balance of consumer protection and social utilities. Finally, the author would like to mention the potential occurrences and issues of a malfunctioning pacemaker in Thailand for all related parties and stakeholders to be prepared for confronting this situation appropriately and equitably.