Članek obravnava problematiko odgovornosti za škodo, ki nastane kot posledica napake izdelka in povzroči smrt, telesno poškodbo ali okvari bolnikovo zdravje. Hiter razvoj znanosti je tudi v medicini omogočil razvoj novih izdelkov in tehnologij, ki vzbujajo pri bolnikih velika pričakovanja po bolj učinkovitem zdravljenju. Vendar pa nove tehnologije s seboj prinašajo tudi tveganje za nastanek poškodb zaradi morebitnih napak. Standardi kakovosti in varnosti izdelkom slabe kakovosti sicer preprečujejo dostop na trg, vendar pa t. i. varnostne norme ne morejo preprečiti napak in nevarnosti, ki jih zaradi omejenosti znanja ne moremo predvideti. Zato do poškodb in z njimi povezanih stroškov kljub vsemu prihaja. V prispevku natančno opredeljujemo, kdo naj nosi nepredvidljive stroške: bolnišnica, proizvajalec, bolnik ali preko socializacije tveganja družba kot celota. Gre za zapleten sistem ekonomske razporeditve tveganja poškodb, ki skuša uravnovesiti željo po učinkovitosti ob upoštevanju nepredvidljivih nevarnosti izdelka. Opredeljujemo pojme, ki so ključni za razumevanje problematike: proizvajalec, potrošnik, bolnik, izdelek in napaka. Največ pozornosti namenjamo sistemu odgovornosti za škodo, ki ga uvaja Direktiva Sveta Evropske Unije 85/374 o odgovornosti za brezhibnost izdelka. Direktiva uvaja sistem, ki ob sprejemu pravil v nacionalno zakonodajo dopušča pravnopolitične prilagoditve. V prispevku analiziramo sistem razporeditve škode in ga skušamo orisati s ključnimi primeri iz prakse sodišč Evropske unije. 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.