Product liability for medicinal pharmaceuticals in Germany

Article type: Research Article

Authors: Magnus, Ulrich

Affiliations: Max-Planck, Germany | E-mail: [email protected]

Correspondence: [*] Corresponding author: Max-Planck, Germany. E-mail: [email protected].

Abstract: In 1976 Germany introduced a special strict liability regime for personal injuries through pharmaceuticals for human consumption. This was in reaction to the Thalidomide-catastrophe in the 1950ies and 1960ies. Since then, Germany disposes of a two lane-system of liability in this field: traditional fault liability under general tort law and strict liability under the special Medicinal Products Act. The following article examines in detail the conditions of liability under either regime. Also, possible defences and procedural matters are being dealt with as well as the question of insurance and the accessibility of funds established for victims.

Keywords: Liability for defective medicinal products, special statutory regulation in Germany, strict liability, causation and damages, fund solutions, producers’ defences and time limits

DOI: 10.3233/PPL-180470

Journal: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 103-114, 2018