Die Zweckmäßigkeit der arzneimittelrechtlichen Gefährdungshaftung

In this doctoral thesis, the medicinal product law strict liability from § 84 AMG is evaluated with regard to its expediency. First, the institute of strict liability is comprehensively explained. The focus of the work is the problem of proving causality.
It becomes clear in the work that even the presumption of causality from § 84 para. 2 AMG does not solve the problems of proof. The author argues for a lowering of the standard of proof and cites European law arguments for this. In the author's opinion, the presumption of causality from § 84 Para. 2 AMG contradicts the European Product Liability Directive, which, in the author's opinion, must guide medicinal product liability.