Germany, Federal Court of Justice, 30 October 2013 VI ZR 284/12 (C-503); VI ZR 327/12 (C-504)

Identification of the case

• Paragraph 1, 3 and 8 of the Gesetz über die Haftung für fehlerhafte Produkte (Law on liability for defective products) of 15 December 1989

• Articles 1, 6 and 9 Directive 85/374/EEC

Summary of the case

G. Corporation, now B. S. Corporation, imported and marketed in Germany ‘Guidant Pulsar 470’ and ‘Guidant Meridian 976’ pacemakers.

G.’s recommendations of 22 July 2005 concerning pacemakers and the subsequent events in Case C-503/13: 

In July 2005 G. notified treating physicians that the pacemakers which it marketed may be defective, and recommended physicians to consider, inter alia, replacing them. G. undertook to make replacement devices available free of charge. Following that recommendation, the pacemakers previously implanted in B and W, who both had medical insurance cover with AOK, were replaced in September and November 2005, respectively, by other pacemakers provided free of charge by the manufacturer. The pacemakers that had been removed were destroyed without any expert opinion being obtained on their functioning.

AOK, brought proceedings before the Amstgericht Stendal claiming compensation for the costs of the original pacemakers. The court upheld that claim and as Boston Scientific Medizintechnik’s appeal against that decision was dismissed by the Landgericht Stendal. The company lodged on appeal on a point of law before the referring court.

G.’s recommendations of June 2005 concerning implantable cardioverter defibrillators and the subsequent events in Case C-504/13: 

In June 2005, G. informed treating physicians that implantable ‘G. Contak Renewal 4 AVT 6’ defibrillators might be defective. G. recommended treating physicians to deactivate the magnetic switch in the defibrillators concerned. On 2 March 2006 the implantable cardioverter defibrillator implanted in F was replaced prematurely. Boston Scientific Medizintechnik was requested reimburse the costs incurred in respect of F’s treatment. The Landgericht Düsseldorf upheld that claim. After Boston Scientific Medizintechnik appealed against that judgment, the Oberlandesgericht Düsseldorf varied that decision in part, ordering that company to pay an alternative sum. The company lodged an appeal on a point of law before the referring court.

The Bundesgerichsthof decided to stay the proceedings and to refer to the Court of Justice for a preliminary ruling questions formulated in a similar manner in both Case C-503/13 and Case C-504/13. By decision of the President of the Court of 2 October 2013, Cases C-503/13 and C-504/13 were joined for the purposes of the written and oral procedure and judgment.

• Criminal judicial enforcement

Maintain that where it is found that products belonging to the same group or forming part of the same production series 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; and the damage caused by a surgical operation for the replacement of a defective product constitutes ‘damage caused by death or personal injuries’.

1. Is Article 6(1) of Directive 85/374 to be interpreted as meaning that a product in the form of a medical device implanted in the human body (in this case, a pacemaker [and an implantable cardioverter defibrillator]) is already defective if [pacemakers] in the same product group have a significantly increased risk of failure [or where a malfunction has occurred in a significant number of defibrillators in the same series], but a defect has not been detected in the device which has been implanted in the specific case in point?

2.  If the answer to the first question is in the affirmative: Do the costs of the operation to remove the product and to implant another pacemaker [or another defibrillator] constitute damage caused by personal injury for the purposes of Article 1 and section (a) of the first paragraph of Article 9 of Directive 85/374?’

Question 1:

When addressing the first question the Court first of all recalled that the definition of “defectiveness” of a product, under Article 6(1) Directive 85/374, depends on whether it does not provide the safety which a person is entitled to expect, considering the reasonable expectations of the public at large. It also pointed out how safety requirements in the case of pacemakers and implantable cardioverter defibrillators should be quite high.

Given the abnormal potential for damage which those products might cause when defective, the Court decided that, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective.

Question 2:

With regard to the second question the Court noted how under Article 1 read in conjunction with section (a) of the first paragraph of Article 9 of Directive 85/374, the producer is liable for damage caused by death or personal injuries which are the result of his product being defective. This is apparent also from the Court’s case-law. Moreover ‘damage caused by death or personal injuries’ must be given a broad interpretation given the objectives of the Directive.

Therefore, the Court concluded 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 in question.

The issue of whether it is sufficient, in Case C-504/13, to deactivate the magnetic switch rather than replacing the whole product is left to the judgment of the national court.

Case C-503/13: 

The seller was found liable to pay for the damages

Case C-504/13:

The appeal was set aside and referred back to the Court of Appeal (Berufungsgericht) due to issues related to the statute of limitations

Role of the Charter and role of the general principles on enforcement

• Effectiveness

The principle of effectiveness is relevant to the reasoning of the Court regarding the fact that persons injured by defective products should be granted full and proper compensation.

To preserve the full effectiveness of the system of liability the seller must be held liable for the 'damage caused by death or personal injuries' resulting from the replacement operation, when such an operation is necessary to overcome the defect in the product in question.  To the same effect  'damage caused by death or personal injuries' must be given a broad interpretation.

Elements of judicial dialogue

• Direct dialogue between CJEU and National court (preliminary reference)

Preliminary reference

Clarify implications of article 6 and 9 of Directive 85/374 with regard to the defectiveness of products and the remedies the consumer is entitled to

Application of the correct interpretation of the Directive

Additional notes on the decision