Odgovornost zbog štete izazvane upotrebom medicinskih sredstava
Manić, Samir O.
Faculty:University of Niš, Faculty of Law
Nikolić, Đorđe L.
Lazić, Miroslav R.
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Liability for damage caused by using medical devices is one of crucial and very actual problems of the law of obligations. It is a very complex social and legal problem, not only because it is not regulated by special legal rules, but also because it is the problem that has only recently gained a character of the mass phenomenon. So far, the content of our legal theory indicates its evident lack of interest in this area of social relations where, except in a couple of smaller articles, this area has not been the subject of any textbook nor a monographic treatment. The essence of this research is reflected in the need to assess the extent to which the general rules of liability for damage are adapted to the nature and specifics of patient's right to damage compensation which is caused by the use of medical devices, i.e., the need to examine whether this right may be exercised exclusively by the rules of subjective liability or it may be exercised according to the rules of strict liability
for damage, with the fulfillment of legal requirements. The task of this research is also the need to examine the liability of the medical devices manufacturer and possible liability of health workers/health institutions for the damage caused by the lack of medical device as a product. More specifically, whether it is possible and to what extent to expand strict liability for damage caused by the defect of medical devices on health workers/health institutions. The subject of analysis will also be the existing systems of liability insurance of health workers, and above all, the possibility of compensation to patients, who have been harmed during the use of medical devices, through existing insurance systems. Liability for damage caused by the use of medical devices requires consideration and investigation of this problem in a broader philosophical, social and economic context, but also processing its legal aspects. The focus of the research is placed on the legal aspects of liability, where in the forefront is the domestic law. Due to the very poor domestic legal theory and jurisprudence, a huge part of the research refers to the comparative law. During the research of the problem, which is the subject of this dissertation, various scientific methods have been used. In addition to the general dialectical method, which is always applied in scientific researches, legal methods (dogmatic and normative method) have also been used in order to determine the content, sense and meaning of legal norms used to regulate the liability for damage caused by medical devices. But, during the research, we have also used the axiological and sociological method and, like secondary method, we have used historical-legal as well as comparative and comparative-legal method, to whose use we have given special emphasis. The research results have shown that the general rules of liability for damage are not adequately adjusted to the nature and specifics of a patient's right to compensation for damage caused by the use of medical devices. Also, the results of the research have shown that patients might exercise that right not only according to the rules of subjective liability, but, with the fulfillment of legal requirements, and according to the rules of strict liability for damage. When it comes to strict liability for damage caused by a defect of medical devices, the results have shown that in certain legal systems, there is a tendency of expansion of this liability to health workers/ health institutiosn. The growing influence of strict liability to the world of health services is visible through the increasing use of "no fault" patients' insurance system.View More
Keywords:medicinsko sredstvo, opasna stvar, objektivna odgovornost, nedostatak proizvoda; medical device, dangerous thing, strict liability, product's defect