잠재적 결함이 있는 이식형 의료기기 관련제조물책임에 대한 유럽사법재판소의 판단 - 유럽사법재판소 2015. 3. 5. 선고 joined cases C - 503/13, C - 504/13 Boston Scientific Medizintechnik 판결을 중심으로 -

The Court of Justice of the EU issued an epoch-making judgment which extends the liability of manufacturer. This case is about the defects of Pacemakers and Implantable Cardioverter Defibrillators (ICDs). After the adoption of the Product Liability Directive(85/374/EEC), Member States transposed it into their national laws. When a national court finds some lacunae or has some questions in interpreting and applying the national law of product liability, the national court is obligated to interpret and apply the national law in consideration of the words and purpose of the Product Liability Directive, according to the doctrine of harmonious interpretation which is one of the principles that ensure the effectiveness of Directives. If the national court still has uncertainties as to the words or the purpose of the Directive, it can request the CJEU to render a preliminary ruling. In the present case, the Bundesgerichsthof requested the CJEU for a preliminary ruling on the interpretation of the Product Liability Directive in relation to some particularly concerned issues debatable in the national procedure. In this case, the manufacturer voluntarily announced the possibility of failure of some pacemakers and ICDs and took corrective measures such as recommending the replacement of the device etc, which consequently triggered this case. The CJEU holds that products such as the pacemakers and ICDs can be considered defective if they are found to belong to the same product series that was previously deemed to have a potential defect, without any need to establish that the product in question has such a defect, and that the compensation for damages must cover the costs relating to the replacement of defective product. However, the CJEU holds that with respect to the pacemaker, the manufacturer is liable for the costs of replacement because it recommended replacement of devices, but concerning the ICDs, it is for the national court to determine whether the replacement is necessary or not, as the manufacturer simply recommended to deactivate the magnetic switch. There are significant differences between the reasoning of the CJEU in this case and the basic structure or the essential concepts of Product Liability Directive. That is, the CJEU holds that a risk of malfunction, without there being any actual malfunction, constitutes a defect, by using the notion of potential defect, and the CJEU reversed the burden of proof by confirming that products can be considered defective without any need to establish if they belong to the same group of products that have potential defects, and the CJEU extends the scope of compensable harm by declaring that the damages resulting from the prevention of injury or death should be also covered. This judgment of CJEU raises many questions in various aspects, about which I discuss in this thesis. It can be said that this judgment reminds the difficulty of finding the right balance of a fair apportionment of the risks between the consumers and the producers under the product liability regime. It may be necessary to solve some questions similar to those of this case someday in Korea. In such an event, cautious approach should be taken both in the area of legislation and in the area of interpretation.