Product liability in medicine

Abstract

Liability for defective products can be based on the contract, on general rules of fault-based tort liability, or on special rules of strict tort law liability. Systems of strict tort law liability were introduced in the mid-1960s of the twentieth century, as an answer to the incapability of the traditional systems of liability to properly address certain particulars of growing number of products-related injuries. Two dominant models of special tortuous product liability regimes are the American model, restated in the Restatement (Third) on Torts and the European model, provided within the Directive 85/374/EEC. Both liability models generally cover medicinal products. These two models significantly depart from one another with respect numerous elements, for example, types of medicinal products covered by each of these systems, the definition of defectiveness, and type of liability imposed with respect certain types of defectiveness. In order to enable victims injured from certain defective medicinal products to obtain quick and fair compensation, some legal systems have supplemented their liability systems with alternative, non-liability compensation mechanisms, as is the case in some Scandinavian countries.