The European Court of Justice issued a judgment stating that even a potential defect may constitute a defect as defined in the European Product Liability Directive and therefore constitutes a product liability claim against the producer.

Ruling: In a case concerning defective pacemakers and implanted cardioverter defibrillators, on 5 March 2015 (Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt - Die Gesundheitskasse (C-503/13) und Betriebskrankenkasse RWE (C-504/13)) the European Court of Justice (ECJ) issued a judgment deciding that if a medical device has a potential defect, all products of the same model may be classified as defective without the claimant having to prove that the product in question is defective. As a result, the costs related to replacing the products are reimbursable because the operation required to replace the defective products constitutes “damage caused by death or by personal injuries” as defined in the European Product Liability Directive 85/374/EEC.

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