Opinion of the Advocate General — ECLI:EU:C:2014:2306
Date: 2014-10-21
Language of the case: German
Subject matter: Consumer protection;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary — Judgment of the Court (Fourth Chamber), 5 March 2015 1. Judicial proceedings — Request that the oral procedure be reopened — Conditions for reopening — Rejection (Statute of the Court of Justice, Art. 23; Rules of Procedure of the Court of Justice, Art. 83) 2. Approximation of laws — Liability for damage caused by defective products –Directive 85/374 — Medical devices — Pacemakers and implantable cardioverter defibrillators — Defectiveness — Conditions — Potential default detected in products belonging to the same group or forming part of the same production series, (Council Directive 85/374, Art. 6(1)) 3. Approximation of laws — Liability for damage caused by defective products –Directive 85/374 — Damage caused by death or by personal injuries — Concept — Broad interpretation (Council Directive 85/374, Art. 9, first para., (a)) 4. Approximation of laws — Liability for damage caused by defective products –Directive 85/374 — Damage to be taken into consideration — Damage caused by a surgical operation for the replacement of a defective product — Operation necessary to overcome the defect in the product — Included — Assessment by the national court [Council Directive 85/374, Arts 1 and. 9, first para., (a)) 1. See the text of the decision. (see paras 32-35) 2. Article 6(1) of Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products must be interpreted as meaning that, where it is found that products belonging to the same group or forming part of the same production series, such as pacemakers and implantable cardioverter defibrillators, have a potential defect, such a product may be classified as defective without there being any need to establish that that product has such a defect. In the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high. Moreover, the potential lack of safety which would give rise to liability on the part of the producer stems, for such products, from the abnormal potential for damage which those products might cause to the person concerned. (see paras 39, 40, 43, operative part 1) 3. The notion of ‘damage caused by death or personal injuries’ within the meaning of section (a) of the first paragraph of Article 9 of Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products must, having regard to the objective of protecting consumer health and safety pursued by that directive in accordance with the first and sixth recitals in the preamble thereto, be given a broad interpretation. (see para. 47) 4. Article 1 and section (a) of the first paragraph of Article 9 of Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products are to be interpreted as meaning that the damage caused by a surgical operation for the replacement of a defective product, such as a pacemaker or an implantable cardioverter defibrillator, constitutes ‘damage caused by death or personal injuries’ for which the producer is liable, if such an operation is necessary to overcome the defect in the product. It is for the national court to determine whether, having regard to the particularly vulnerable situation of patients using an implantable cardioverter defibrillator, the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product, bearing in mind the abnormal risk of damage to which it subjects the patients concerned, or whether it is necessary to replace that product in order to overcome the defect. (see paras 54, 55, operative part 2)