Liability of Pacemaker and Defibrillator Importers Under the Product Liability Act of B.E.2551: Lessons from the United State and EU

Abstract

The theme of this paper is to identify the liability of importers of defective or potentially defective pacemakers and defibrillators in Thailand. Defective lead wiring can lead to serious cardiac injury, such as arrhythmia and possible death. A shorter-than-expected life span battery or defective magnetic switch can lead to the necessity of preventive surgical operation to remove a defective pacemaker or defibrillator and to replace it with a new one. The paper discusses liability of manufacturers of these two medical devices under tort, product liability law and the Medical Device Act in the United States as it has the longest experience grappling with these problems. In the United States, stringent approval of the design by the Federal Food and Drug Administration immunizes the manufacturer from strict liability. The paper also analyses German tort law, as well as EU and German product liability laws and German Medical Device Act. Then it explores liability of importers of these two products. Finally, the paper examines relevant Thai laws, including tort law, product liability and regulatory regime of the Thai Medical Device Act. The Thai Medical Device Control Division of the Thai FDA does not perform local examination on imported pacemakers and defibrillators. The approval process is only on documentations. It concludes that Thailand should not follow the experience of the United States with regards to accidents caused by defective lead wiring, and should follow the experience of Germany with regards to interpretation of “defective” and “damage” with regards to the surgical expenses of replacing a pacemaker or defibrillator that has not malfunctioned yet.