Sistem produktne odgovornosti v zdravstvu

This article deals with the issue of liability for damages caused by product defectiveness resulting in death, physical injury, or failure in patient health. The rapid development of science has led to the development of new products and technologies in medicine, which resulted in higher expectations from patients for more effective treatments. However, new technologies engender higher risk of injuries arising from errors in new technologies. While standards for quality and safety can prevent products of poor quality from appearing on the market, the same safety standards cannot prevent defects and hazards that cannot be foreseen due to the limitations of human knowledge. Despite this, injuries and the subsequent medical costs continue to occur. This article specifies which party will bear the cost for such contingencies, whether it will be the hospital, the manufacturer, the patient, or society as a whole through socialisation of risk. It is a complex system of economic distribution of the risk of injury, which seeks to balance the desire for efficiency by considering the unpredictable hazards of a product. Key concepts are identified for understanding the problem: manufacturer, consumer, patient, product and defect. The emphasis is on the system of liability for damages established by Council Directive 85/374/EEC of the Council of the European Union concerning liability for defective products. The Directive introduces a system, which allows legal and political adjustments when integrated into the national legislation. This paper analyses a system of damage distribution with key examples from the practice of European Union courts shaped upon the disputed areas.