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

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ศักดา ธนิตกุล
โชติกา วิทยาวรากุล


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.

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5. The Food Drug and Cosmetic Act 21 U.S.C. § 301 et seq.
6. One might ask if the United States Supreme Court could establish for all 50 states if a product is defective or not. The short answer is, no. Many complex cases are tried in federal courts under the civil procedure doctrine of “diversity jurisdiction” were all the defendants and all of the plaintiffs reside in different states. Be that as it may, the law that the federal courts under diversity jurisdiction is state, not federal law. And even then, the Supreme Court only determines questions of law, never fact, and if a product is defective is a matter or fact.
7. Marmol v. St Jude Medical Center and Pacesetter, Inc., 132 F.Supp.3d 1359, 2015.
8. Boston Scientific Madizintechnik GmBH v AOK Sachsen-An-halt-Dei Gesundheits kasse, 21 October 2014 (C-503/13)
9. Boston Scientific Madizintechnik GmBH v Betriebskrankenkasse RWE, 21 October 2014 (C-504/13)
10. Section 6 of the Thai product liability act say “… shall prove that the damage party sustained damage from the product of the entrepreneurs, and the use or storage of the product was done in a normal manner. …”
11. คำพิพากษาศาลแพ่ง คดีหมายเลขแดงที่ ผบ.4224/2557