Brussels, 05/03/2015 (Agence Europe) - Where a medical device has a potential defect, all products of the same model may be classified as defective and the manufacturer must reimburse the costs relating to replacement of the product, the Court of Justice of the EU ruled on Thursday 5 March (joined cases C-503/13 and C-504/13).
These proceedings related to pacemakers and defibrillators made by Boston Scientific Medizintechnik GmbH (BSM) and marketed in Germany. BSM informed doctors of a potential defect in some of its products and recommended replacement, providing new pacemakers free of charge. No defect was later detected in any of the devices removed. The makers refused to bear the cost of the operations to replace the devices.
The Court followed the opinion of Advocate General Yves Bot, delivered in October 2014 (see EUROPE 11182). Given that the medical devices in question are subject to particularly high safety requirements, a potential defect in a product makes it possible to classify as defective all products of the same model, without there being any need to show that the product is defective in each individual case. The makers must bear the cost of each medical operation to replace any such product. (Jan Kordys)