Resuscitating EU Product Liability Law? Contemplating the Effects of Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt and Betriebskrankenkasse RWE (Joined Cases C-503/13 and C-504/13)

Abstract

On 5 March 2015 the Court of Justice of the European Union gave an important judgment that may help to bolster the importance of the Product Liability Directive and its national implementing regimes for the legal practice of product liability law. In two joined cases, the Court held that products, such as the implantable medical devices in this case, can be considered defective if they were found to belong to the same group or formed part of the same product series that had a potential defect, without there being any need to establish that the product in question had such a defect. Moreover, the Court held that the damage incurred because of the removal of these defective devices from the human body came within the scope of the concept of damages as described by the Directive and could be claimed under its implementing laws. Will this decision “resuscitate” the Directive, which has been considered a dead letter in the legal practice of European product liability law? In this paper we assess this claim and outline the consequences of the Court’s judgment in Boston Scientific Medizintechnik.

Keywords: Product liability, defect, risk, damage, medical devices

JEL Classification: K13, K23, K32