engleski

ECONOMIC ANALYSIS OF ECJ JUDGEMENT IN JOINED CASES C-503/13 & C-504/13: PRODUCT RECALLS REGARDING MEDICAL DEVICES

The risk of damage is necessarily, part of many socially, beneficial activities and can only be fully eliminated by adequately discontinuing these activities. As an alternative, the social costs of risky activities can be minimized by a reasonable investment in precautionary measures in accordance with the precautionary principle. In its essence, it contains the requirement to act preventively in the case of danger of the occurrence of serious and/or irreparable damage, even in the case where there is no scientifically confirmed certainty of occurrence of harmful consequences. Due to their, , inciting power': liability rules can influence individuals' behavior. Altering liability rules also alters their control effect. Such decisions of legislature or judicature can be evaluated by the economic outcomes of the altered control effect. In this paper, the efficiency effects of liability rules regarding product liability are analyzed. The product recall of implanted medical devices as in the ECJ Judgment from 5th March 2015 in the joined cases C-503/13 and C- 504/13 is examined in detail. Contrary to the economic considerations, health protection is pursued with the Product Liability Directive. Though the ECJ extended the liability only to recalls, necessary due to the devices particular danger. A general recall obligation was explicitly not implemented, but the judgment introduced the opportunity to stipulate a recall obligation on a case-by-case basis. The additional incentives set by contractual liability and tortious producer liability were not within the scope of the analysis. A multi- level precaution model could include precautionary measures while development, production, and monitoring of products. Other measures as a producers' obligation were not examined. The liability for a defect-free device, influencing the level of harm and the recall costs in the model, was excluded too, A need for further research in that subject remains.

EU Product Liability Directive ; EJC judgment C-503/13 & C-504/13 ; precautionary principle ; unilateral precaution model

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