N. W and Others v Sanofi Pasteur MSD SNC and Others.
Date: 2017-03-07
20


Similarly, it must be remembered that, according to settled case-law, Directive 85/374 seeks to achieve, in the matters regulated by it, complete harmonisation of the laws, regulations and administrative provisions of the Member States (judgment of 20 November 2014, Novo Nordisk Pharma, C‑310/13, EU:C:2014:2385, paragraph 23 and the case-law cited).
21


However, as can be seen from the 18th recital thereof, Directive 85/374 does not seek exhaustively to harmonise the sphere of liability for defective products beyond the matters regulated by it (judgment of 20 November 2014, Novo Nordisk Pharma, C‑310/13, EU:C:2014:2385, paragraph 24 and the case-law cited).
23


As is apparent from Article 6(1) of that directive, a product is defective when it does not provide the safety which a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that it would be put and the time when the product was put into circulation. Moreover, according to the sixth recital of that directive, that assessment must be carried out having regard to the reasonable expectations of the public at large (judgment of 5 March 2015, Boston Scientific Medizintechnik, C‑503/13 and C‑504/13, EU:C:2015:148, paragraph 37).
24


Moreover, as regards proof, it must be emphasised that although, as observed in paragraph 19 of this judgment, Article 4 of Directive 85/374 provides that the victim has the burden of proof, neither Article 4 nor any other provision of that directive addresses the other aspects relating to how that proof is to be made out (see, to that effect, judgment of 20 November 2014, Novo Nordisk Pharma, C‑310/13, EU:C:2014:2385, paragraphs 25 to 29).
25


In those circumstances, under the principle of procedural autonomy and subject to the principles of equivalency and effectiveness, it is for the national legal order of each Member State to establish the ways in which evidence is to be elicited, what evidence is to be admissible before the appropriate national court, or the principles governing that court’s assessment of the probative value of the evidence adduced before it and also the level of proof required (see, by analogy, judgments of 15 October 2015, Nike European Operations Netherlands, C‑310/14, EU:C:2015:690, paragraphs 27 and 28, and of 21 January 2016, Eturas and Others, C‑74/14, EU:C:2016:42, paragraphs 30 and 32).
26


Regarding more specifically the principle of effectiveness, it requires, in terms of the detailed procedural rules governing actions for safeguarding rights which individuals derive directly from EU law, that those rules do not render practically impossible or excessively difficult the exercise of rights conferred by EU law (see, to that effect, inter alia, judgment of 10 April 2003, Steffensen, C‑276/01, EU:C:2003:228, paragraph 60 and the case-law cited).
27


As regards, more specifically, Directive 85/374, it follows from the Court of Justice’s case-law that the national rules governing how evidence is to be adduced and appraised must not be such as to undermine either the apportionment of the burden of proof as provided for under Article 4 of that directive nor, more generally, the effectiveness of the system of liability provided for under Directive 85/374 or the objectives pursued by the EU legislature by means of that system (see, to that effect, judgment of 20 November 2014, Novo Nordisk Pharma, C‑310/13, EU:C:2014:2385, paragraphs 26 and 30 and the case-law cited).
29


However, such evidentiary rules do not bring about a reversal of the burden of proof which, as provided for in Article 4 of Directive 85/374, it is for the victim to discharge, since that system places the burden on the victim to prove the various elements of his case which, where applicable, taken together will provide the court hearing the case with a basis for its conclusion as to the existence of a defect in the vaccine and a causal link between that defect and the damage suffered (see, by analogy, judgment of 20 November 2014, Novo Nordisk Pharma, C‑310/13, EU:C:2014:2385, paragraphs 26 to 28).
31


As observed by the Advocate General in point 45 of his Opinion, such a high evidentiary standard, which amounts to excluding any method of proof other than certain proof based on medical research, could make it excessively difficult in many situations or, as in the present case, where it is common ground that medical research neither confirms nor rules out the existence of such a causal link, impossible to establish producer liability, thereby undermining the effectiveness of Article 1 of Directive 85/374 (see, by analogy, judgment of 9 November 1983, San Giorgio, 199/82, EU:C:1983:318, paragraph 14).
32


Such a limitation as to the types of admissible evidence would also be inconsistent with the objectives pursued by Directive 85/374, seeking to ensure, in particular, as is apparent from the second and seventh recitals thereof, a fair apportionment of the risks inherent in modern technological production between the injured person and the producer (see, to that effect, judgment of 5 March 2015, Boston Scientific Medizintechnik, C‑503/13 and C‑504/13, EU:C:2015:148, paragraph 42) and, as evidenced by the first and sixth recitals thereof, that of protecting consumer health and safety (see, to that effect, judgment of 5 March 2015, Boston ScientificMedizintechnik, C‑503/13 and C‑504/13, EU:C:2015:148, paragraph 47).
33


Although, as shown by the discussion in paragraphs 28 to 32 of this judgment, national evidentiary rules such as those described in paragraph 28 above, which are ostensibly neutral as to the burden of proof referred to in Article 4 of Directive 85/374 and, in principle, capable of preserving the effectiveness of the system of liability provided for by that directive whilst ensuring compliance with the objectives pursued by it, the fact remains that the actual scope of such rules must be determined in the light of the interpretation and application given to them by national courts (see, by analogy, judgment of 9 December 2003, Commission v Italy, C‑129/00, EU:C:2003:656, paragraph 31).
35


As observed by the Advocate General in points 54, 60 and 75 of his Opinion, that could arise firstly in a situation where national courts apply those evidentiary rules in an overly rigorous manner by accepting irrelevant or insufficient evidence (see, by analogy, judgment of 15 October 2015, Nike European Operations Netherlands, C‑310/14, EU:C:2015:690, paragraphs 29 and 43). In such a situation, there would be disregard not only of the rule on burden of proof laid down in Article 4 of Directive 85/374 but also, more generally, the effectiveness of the system of liability introduced by Article 1 of that directive, since the issue whether two of the three conditions on which producer’s liability under that directive is contingent, namely the existence of a defect in the product and a causal link between that defect and the damage suffered by the victim, were met would not be sufficiently examined by the national court.
36


Secondly, disregard of the burden of proof could also result if the national courts were to apply the evidentiary rules described in paragraph 28 of this judgment in such a way that, where one or more types of factual evidence were presented together, an immediate and automatic presumption would operate of there being a defect in the product and/or a causal link between that defect and the occurrence of the damage. In such circumstances, 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 (see, by analogy, judgments of 9 November 1983, San Giorgio, 199/82, EU:C:1983:318, paragraph 14, and of 9 February 1999, Dilexport, C‑343/96, EU:C:1999:59, paragraph 52).
38


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).
40


According to settled case-law, the Court may, however, in the framework of the judicial cooperation provided for by that article and on the basis of the material presented to it, provide the national court with an interpretation of EU law which may be useful to it in assessing the effects of such rules (see, inter alia, judgment of 28 September 2006, Van Straaten, C‑150/05, EU:C:2006:614, paragraph 37 and the case-law cited).
41


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).
48


It should be borne in mind in that regard that the safeguarding of rights enjoyed by individuals by virtue of the relevant Treaty provisions depends, to a large extent, on successive legal categorisations of facts. Similarly, it should be noted that when a court, like the referring court in the present case, is called upon to rule at final instance, it is responsible inter alia for ensuring, on a nationwide scale, uniform interpretation of the legal rules (see, to that effect, judgment of 13 June 2006, Traghetti del Mediterraneo, C‑173/03, EU:C:2006:391, paragraph 36).
49


The fact remains, however, that the Court does not have jurisdiction to interpret national law and that only the national courts may determine the exact scope of national legislative, statutory or administrative provisions. This holds true inter alia for national provisions on proof (see, to that effect, judgment of 9 February 1999, Dilexport, C‑343/96, EU:C:1999:59, paragraph 51 and the case-law cited) and for rules demarcating the respective jurisdictions of national courts.
50


As regards national provisions on proof, covered by the first question, it must nevertheless be emphasised that the national courts called on to apply them must take account of both the principles referred to in paragraphs 37 and 38 of this judgment and of the principle of legal certainty, the corollary of which is the principle of the protection of legitimate expectations, which requires, in particular, that the application of rules of law must be foreseeable by those subject to them (judgment of 2 December 2009, Aventis Pasteur, C‑358/08, EU:C:2009:744, paragraph 47 and the case-law cited).