# C_2016048EN.01001802.xml

| 8.2.2016 | EN | Official Journal of the European Union | C 48/18 |
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8.2.2016

EN

Official Journal of the European Union

C 48/18

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Request for a preliminary ruling from the Cour de cassation (France) lodged on 23 November 2015 –W and Others v Sanofi Pasteur MSD SNC, Caisse primaire d’assurance maladie des Hauts-de-Seine, Caisse Carpimko

(Case C-621/15)

(2016/C 048/25)

Language of the case: French

Referring court

Referring court

Cour de cassation

Parties to the main proceedings

Parties to the main proceedings

Applicants: W and Others

Applicants:

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

Defendant:

Questions referred

Questions referred

| 1. | Must Article 4 of Council Directive 85/374/EEC (1) of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products be interpreted as precluding, in the area of liability of pharmaceutical laboratories for the vaccines that they manufacture, a method of proof by which the court ruling on the merits, in the exercise of its exclusive jurisdiction to appraise the facts, may consider that the facts relied on by the applicant constitute serious, specific and consistent presumptions capable of proving the defect in the vaccine and the existence of a causal relationship between it and the disease, notwithstanding the finding that medical research does not establish a relationship between the vaccine and the occurrence of the disease? |
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1.

Must Article 4 of Council Directive 85/374/EEC (1) of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products be interpreted as precluding, in the area of liability of pharmaceutical laboratories for the vaccines that they manufacture, a method of proof by which the court ruling on the merits, in the exercise of its exclusive jurisdiction to appraise the facts, may consider that the facts relied on by the applicant constitute serious, specific and consistent presumptions capable of proving the defect in the vaccine and the existence of a causal relationship between it and the disease, notwithstanding the finding that medical research does not establish a relationship between the vaccine and the occurrence of the disease?

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| 2. | If the answer to Question 1 is in the negative, does Article 4 of Directive 85/374, cited above, preclude a system of presumptions by which the existence of a causal relationship between the defect attributed to a vaccine and the damage suffered by the injured person will always be considered to be established where certain indications of causation are found? |
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2.

If the answer to Question 1 is in the negative, does Article 4 of Directive 85/374, cited above, preclude a system of presumptions by which the existence of a causal relationship between the defect attributed to a vaccine and the damage suffered by the injured person will always be considered to be established where certain indications of causation are found?

| 3. | If the answer to Question 1 is in the affirmative, must Article 4 of Directive 85/374, cited above, be interpreted as meaning that proof, the burden of which rests on the person injured, of the existence of a causal relationship between the defect attributed to a vaccine and the damage suffered by that person cannot be considered to have been adduced unless the causal relationship is established scientifically? |
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3.

If the answer to Question 1 is in the affirmative, must Article 4 of Directive 85/374, cited above, be interpreted as meaning that proof, the burden of which rests on the person injured, of the existence of a causal relationship between the defect attributed to a vaccine and the damage suffered by that person cannot be considered to have been adduced unless the causal relationship is established scientifically?

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(1)  OJ L 210, p. 29.

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