Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 19 September 2013 – Boston Scientific Medizintechnik GmbH v Betriebskrankenkasse RWE
(Case C-504/13)
Language of the case: German
Referring court
Bundesgerichtshof
Parties to the main proceedings
Appellant on a point of law: Boston Scientific Medizintechnik GmbH
Respondent on a point of law: Betriebskrankenkasse RWE
Questions referred
Is Article 6(1) of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products 1 to be interpreted as meaning that a product in the form of a medical device which is implanted in the human body (in this case, an implantable cardioverter defibrillator – ICD) is already defective if a malfunction has occurred in a significant number of devices in the same series, but a defect has not been detected in the device which has been implanted in the specific case in point?
If the answer to the first question is in the affirmative:
Do the costs of the operation to remove the product and implant another ICD constitute damage caused by personal injury for the purposes of Article 1 and point (a) of the first sentence of Article 9 of Directive 85/374/EEC?
________________________1 OJ 1985 L 210, p. 29.