Gamintojo civilinė atsakomybė už netinkamos kokybės vaisto padarytą žalą ; Manufacturer's civil liability for damages caused by defective pharmaceutical product

Abstract

This master thesis analyses main aspects of manufacturer's civil liability for the damage caused by defective pharmaceutical product. Conditions of manufacturer's strict liability in chosen aspect were ulmost unanalyzed in legal doctrine of Lithuania. However interpretation and application of these conditions of liability are important to ensure balance between interests of consumers of pharmaceutical products and manufacturers as well as progress of medical science. This master thesis discloses the change of conception of manufacturer's civil liability for the damage caused by defective pharmaceutical product in Europe countries and United States of America, what regulation of manufacturer's civil liability is established in legislation of European Union, topic of its transfer to legislation of European Union Member States, discussed procedures how pharmaceutical products safety is ensured. The main attention is paid to pharmaceutical product defectiveness and exemption of manufacturer from civil liability based on product development risk defence interpretation in judicial practice and legal doctrine. Contradictions between articles of Directive 85/374/EEC do not allow to implement principle of strict liability in its full extent, while implementation of product development risk defence provisions in strict liability may be seen as introduction of fault based tortious liability. However in judicial practice of Europe countries doctrine of consumer's legitimate expectations is followed and manufacturer's civil liability without fault is applied fairly consistently.