Patient Protection Against Unsafe Medical Devices in German and U.S. Law

The work examines the extent to which regulation and product liability law in Germany and the U.S. encourages manufacturers to bring safe and innovative medical devices to market and how product safety could be further increased in both legal systems. The safety standard is defined in the light of product safety, availability, cost and innovation - and thus taking into account the interests of both manufacturers and consumers. With these aspects in mind, each legal system and its economic and practical effects are first examined separately and then compared. A particular focus lies on the analysis of the interplay between regulation and strict product liability law.