Case summary

Deciding Body
Federal Court of Justice
National case details
Date of decision: 06.05.13
Registration ID: Registration n. VI ZR 328/11
Instance: Appellate on fact and law
Case status: Final
Area of law
Consumer protection
Defective goods (consumer sale)

Relevant principles applied
Preliminary ruling
Judgement of the CJEU (Fourth Chamber), 2 November 2014, Case C-310/13 Novo Nordisk Pharma GmbH v S.

Life-cycle diagram

  1. 6 May 2013

    Federal Court of Justice, request preliminary ruling

  2. 20 November 2014

    CJEU, Case C-310/13

  3. 12 May 2015

    Federal Court of Justice

Identification of the case

National law sources
  • Paragraph 84 Arzneimittelgesetz of 24 August 1976
EU law sources
  • Article 13 Directive 85/374

Summary of the case

Facts of the case

During the period from 2004 to June 2006, Ms S., who suffers from diabetes, was prescribed and administered Levemir, a medicinal product manufactured by Novo Nordisk Pharma, which caused her to suffer lipoatrophy, which is the loss of subcutaneous fat tissue at the injection sites.

Ms S. brought proceedings before the Landgericht Berlin (Regional Court, Berlin) seeking the disclosure by Novo Nordisk Pharma, pursuant to Paragraph 84a of the AMG, of information on the adverse and other effects of Levemir inasmuch as they relate to lipoatrophy. The Landgericht Berlin upheld the claims made by Ms S. Novo Nordisk Pharma’s appeal against that judgment was dismissed by the Kammergericht Berlin (Higher Regional Court, Berlin), whereupon that company lodged an appeal on a point of law before the Bundesgerichtshof (Federal Court of Justice; or ‘the referring court’). The referring court states that the outcome of that appeal on a point of law, which relates to the right to information, referred to in Paragraph 84a of the AMG, depends on whether such a provision infringes Directive 85/374.

In those circumstances, the Bundesgerichtshof decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling.

Type of enforcement
  • Civil judicial enforcement
Measures, actions, remedies claimed/applied

Ensure the right of the consumer, given by national law, to receive information on the adverse effects of medical products

Preliminary questions

Must Article 13 of Directive 85/374 be interpreted as meaning that, as a “special liability system”, the German system of liability for pharmaceutical products is not affected by that directive, with the result that the national system of liability for pharmaceutical products may be further developed or must that provision be interpreted as meaning that the situations covered by the liability system for pharmaceutical products existing at the time when the directive was notified (30 July 1985) may not be extended?’

Reasoning (legal principles applied)

In its decision, the Court started by recalling that Article 13 of Directive 85/374 does not affect any rights which an injured person may have under a special liability system existing on the date when the directive was notified. The issue lies on whether Directive 85/374 precludes rules forming part of such a national liability system, under which the consumer has a right to information on the adverse effects of a product.

Taking into account the goals of the Directive and the characteristics of the system of liability in question, the Court determined that the consumer’s right to require the manufacturer of a product to provide him with information on the adverse effects of that product is not among the matters governed by Directive 85/374.

As long as the national procedural rules do not reverse the burden of proof, and as long as the effectiveness of the system of liability, as in this case, is preserved, Directive 85/374 must be interpreted as not precluding national legislation — such as that at issue— under which, in consequence of an amendment to that legislation made after the directive had been notified to the Member State concerned, the consumer has the right to require the manufacturer of the medicinal product to provide him with information on the adverse effects of that product.

Implementation of preliminary ruling

The national court acknowledged how the right of the consumer to obtain information from the manufacturer of a product on its adverse effects does not fall within the scope of Directive 85/374 / EEC.

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

Relevant principles applied
  • Effectiveness
Principle of effectiveness

The principle of effectiveness was mentioned by the Court when explaining how the effectiveness of the system of liability provided for under Directive 85/374 must be not be undermined by national legislation.

Elements of judicial dialogue

Vertical dialogue type
  • Direct dialogue between CJEU and National court (preliminary reference)
Dialogue techniques

Preliminary reference

Purposes of using judicial dialogue

Address a possible incompatibility between national law and EU law

Expected effects of judicial dialogue

Continue to apply national law as no incompatibility was found

Additional notes on the decision

External links

Case author

Comparative, European and International Legal Studies Student Silvia Ciacchi, University of Trento

Published by Silvia Ciacchi on 16 October 2019