European Review of Private Law

Volume 24 (2016)

Volume 24 (2016) / Issue 5

Jan De Bruyne, Cedric Vanleenhove, 'Liability in the Medical Sector: The ‘Breast-Taking’ Consequences of the Poly Implant Prothèse Case' (2016) 24 European Review of Private Law, Issue 5, pp. 823–854


The article deals with the liability of third-party certifiers in the medical sector and especially focuses on the role of TüV Rheinland in the recent Poly Implant Prothèse (PIP) breast implant case. The aim of the contribution is twofold. Firstly, it provides an overview of the different challenges that courts face when having to decide on the liability of certifiers of medical devices towards third parties. These, for instance, relate to the strict conditions under which certifiers can incur third-party liability under national law. Whether product certifiers can be held liable depends on the jurisdiction where the claims have been filed. Therefore, the PIP breast implant case is also interesting from a private international law perspective. Third-party certifiers can be sued before the courts of their domicile. Whether they can be brought before courts in other Member States depends inter alia on the interpretation of the place of the damaging event and the place of the damage. The difficulty to pinpoint these locations not only emerges in the field of jurisdiction but also manifests itself within the search for the applicable law as identical connecting factors are employed in that area of private international law. Secondly, the article examines the decisions that have been issued by national courts in the PIP breast implant case. Rulings in France and Germany denied compensation for patients who purchased the defective breast implants. The PIP case is currently pending before the European Court of Justice (ECJ). It thus remains to be seen what stance the ECJ will take and especially what the consequences might be for certifiers in the medical sector. Based on the analysis of these decisions, the contribution puts forth a number of reasons why the threat of liability seems the most effective way to guarantee that third-party certifiers issue accurate and reliable certificates. This in turn ensures that only safe medical devices are placed on the European market and safeguards the health of consumers. Future scandals with medical devices might in this way be prevented.

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ISSN: 0928-9801
ID: ERPL2016047