Official Journal of the European Union

C 277/8

(Case C-621/15) (<a id="ntc1-C_2017277EN.01000802-E0001" href="#ntr1-C_2017277EN.01000802-E0001"> (<span class="super note-tag">1</span>)</a>)

((Reference for a preliminary ruling - Directive 85/374/EEC - Liability for defective products - Article 4 - Pharmaceutical laboratories - Vaccination against hepatitis B - Multiple sclerosis - Proof of defect of vaccine and of causal link between the defect and the damage suffered - Burden of proof - Methods of proof - Lack of scientific consensus - Serious, specific and consistent evidence left to the discretion of the court ruling on the merits - Whether permissible - Conditions))

(2017/C 277/10)

Language of the case: French

Referring court

Parties to the main proceedings

Applicants: N.W, L.W, C.W

Defendants: Sanofi Pasteur MSD SNC, Caisse primaire d’assurance maladie des Hauts-de-Seine, Carpimko

Operative part of the judgment

1.Article 4 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 must be interpreted as not precluding national evidentiary rules such as those at issue in the main proceedings under which, when a court ruling on the merits of an action involving the liability of the producer of a vaccine due to an alleged defect in that vaccine, in the exercise of its exclusive jurisdiction to appraise the facts, may consider that, notwithstanding the finding that medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease, certain factual evidence relied on by the applicant constitutes serious, specific and consistent evidence enabling it to conclude that there is a defect in the vaccine and that there is a causal link between that defect and that disease. National courts must, however, ensure that their specific application of those evidentiary rules does not result in the burden of proof introduced by Article 4 being disregarded or the effectiveness of the system of liability introduced by that directive being undermined.

2.Article 4 of Directive 85/374 must be interpreted as precluding evidentiary rules based on presumptions according to which, where medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease, the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established when certain predetermined causation-related factual evidence is presented.

(<a id="ntr1-C_2017277EN.01000802-E0001" href="#ntc1-C_2017277EN.01000802-E0001">(<span class="super">1</span>)</a> <a href="./../../../../legal-content/EN/AUTO/?uri=OJ:C:2016:048:TOC">OJ C 48, 8.2.2016</a>.)