Case C‑621/15

N.W and Others

v

Sanofi Pasteur MSD SNC and Others

(Request for a preliminary ruling from the Cour de cassation (France))

(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)

Summary — Judgment of the Court (Second Chamber), 21 June 2017

1. Approximation of laws—Liability for defective products—Directive 85/374—Action seeking to have pharmaceutical laboratories held liable for a defect in a vaccine—Proof of defect of vaccine and of causal link between the defect and the occurrence of the disease—Methods of proof—National evidentiary rules enabling the conclusion that, despite the lack of scientific consensus, there is a defect in the vaccine and that there is a causal link between that defect and the disease, on the basis of serious, specific and consistent evidence left to the discretion of the court ruling on the merits—Lawfulness—Conditions

   (Council Directive 85/374, Art. 4)

2. Approximation of laws—Liability for defective products—Directive 85/374—Action seeking to have pharmaceutical laboratories held liable for a defect in a vaccine—Proof of defect of vaccine and of causal link between the defect and the occurrence of the disease—Burden and methods of proof—National evidentiary rules based on presumptions according to which, despite the lack of scientific consensus, the existence of a causal link between the defect in the vaccine and the occurrence of the disease will always be considered to be established when certain predetermined causation-related factual evidence is presented—Not permissible

   (Council Directive 85/374, Art. 4)

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.

   Thus, firstly, national courts must first ensure that the evidence adduced is sufficiently serious, specific and consistent to warrant the conclusion that, notwithstanding the evidence produced and the arguments put forward by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established.

   Secondly, those same courts must ensure that the principle that it is for the victim to prove, through all means of proof generally allowed under national law and, as in the present case, inter alia through the production of serious, specific and consistent evidence, that there is a defect in the vaccine and a causal link, remains intact. This requires the court to safeguard its own freedom of assessment in determining whether such proof has been made out to the requisite legal standard, until such time as, having examined all the evidence adduced by both parties and the arguments exchanged by them, it considers itself in a position to draw a definitive conclusion on the matter, having regard to all the relevant circumstances of the case before it (see, by analogy, judgment of 9 November 1983, San Giorgio, 199/82, EU:C:1983:318, paragraph 14).

   In the present case, evidence such as that relied on in the main proceedings relating to the temporal proximity between the administering of a vaccine and the occurrence of a disease and the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together where applicable, may lead a national court to consider that a victim has discharged his burden of proof under Article 4 of Directive 85/374. That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect, taking all circumstances into account, as provided for in Article 6 of that directive, because it causes abnormal and particularly serious damage to the patient who, in the light of the nature and function of the product, is entitled to expect a particularly high level of safety (see, to that effect, judgment of 5 March 2015, Boston Scientific Medizintechnik, C‑503/13 and C‑504/13, EU:C:2015:148, paragraph 39).

   (see paras 37, 38, 41, 43, operative part 1)

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.

   In stating in its question that once certain pre-determined facts are established, the existence of such a causal link will ‘always be considered to be established’, the referring court seems to refer to an irrefutable presumption. However, such a presumption would have the consequence that, even where the pre-identified facts are not, hypothetically, capable of establishing with certainty the existence of such a causal link, the producer would, in such a case, be deprived of all opportunity to adduce facts or put forward arguments, such as scientific arguments, in order to rebut that presumption, and the court would thus not have any opportunity to assess the facts in the light of that evidence or those arguments. In being so automatic, such a situation would not only undermine the principle set out in Article 4 of Directive 85/374 by which the victim has the burden of proof of the defect and the causal link, but would also risk compromising the very effectiveness of the system of liability introduced by that directive. The presence of one of the three conditions for engaging the liability of the producer under that directive would then be imposed on the court, without its even having the possibility of examining whether the other facts submitted to it for assessment in the case before it might not lead to the opposite conclusion.

   Moreover, even if the presumption envisaged by the referring court were to be refutable, the fact remains that, since the facts pre-identified by the legislature or supreme judicial body would be proven, the existence of a causal link would be automatically presumed, with the result that the producer could then find itself, even before the courts ruling on the merits of the case had the opportunity to familiarise themselves with the producer’s evidence and arguments, in the position of having to rebut that presumption in order to defend itself successfully against the claim. As observed in paragraph 36 above, such a situation would lead to the burden of proof provided for in Article 4 of Directive 85/374 being disregarded.

   (see paras 53-55, operative part 2)