Volume 24 (2016) / Issue 3/4
Abstract: This article discusses the impact of product liability law on product safety regulation, with special reference to ‘medical devices’. Four aspects are highlighted in particular: first, a short reference to the experiences of and controversies in the United States on this subject; second, an analysis of the recent case law of the Court of Justice of the European Union (CJEU), which interprets product liability law under Directive 85/374/EEC as a supplementary instrument of product safety regulation; third, an examination of the limits of product liability in cases of bankruptcy of the manufacturer, as in the case of the ‘affaire PIP’; and fourth, a discussion of the attempt to hold a so-called ‘notified body’ (i.e., the EU certification agency) liable for defective medical devices in the litigation concerning defective breast implants in terms of Directive 93/42/EEC and the relevant rules of national law. The German Federal Supreme Court has recently decided to refer the matter to the CJEU for a preliminary ruling and has argued that, under the EU effectiveness principle, product liability law has a regulatory function, especially when sensitive health issues, raised by defective medical devices implanted into the human body, are at stake – as in the ‘affaire PIP’.
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