France, Cassation Court, 12 November 2015 14-18118

Identification of the case

• Articles 1386-1 and 1386-9 of the French Civil Code

• Article 4 Directive 85/374/CEE

Summary of the case

Mr W was vaccinated against hepatitis between December 1998 and July 1999. His health began deteriorating in August of that year, and he was finally diagnosed with multiple sclerosis (MS) in November 2000. As of January 2001 he was no longer fit to work, and he eventually died of the disease in October 2011. In 2006, Mr W and W and three members of his family, had brought proceedings on the basis of Article 1386-1 et seq. of the Civil Code, seeking to have Sanofi Pasteur ordered to pay compensation for damages. On the grounds of previous French case law practice, they claimed that the short period between the vaccination and the appearance of the first symptoms of multiple sclerosis, in conjunction with the lack of any personal or family history of the disease, constituted a serious, specific and consistent presumption of the existence of a defect in the vaccine and therefore the Court could take those presumptions as sufficient proof of there being a causal link between the injection and the occurrence of the multiple sclerosis, notwithstanding the lack of definitive scientific proof.

The action brought by the family members of Mr W was upheld at first instance by the Tribunal de Grande Instance de Nanterre, the sentence was subsequently overturned on appeal by the Cour d’Appel de Versailles in a judgment of 10 February 2011. An appeal against that judgment was then brought before the Cour de Cassation ,which quashed it by judgment of 26 September 2012. The case was then sent before the Cour d’Appel de Paris, which again overturned the first instance judgment of the Tribunal de Grande Instance de Nanterre by judgment of 7 March 2014.

The cause of disagreement between the Courts at the various instances always being the extent to which the empirical conclusions medical research (or lack thereof) could be superseded by the “serious specific and consistent presumptions” test.

A new appeal on a point of law was finally brought by W and Others against that judgment to the Cour de Cassation, which requested preliminary ruling regarding the legitimacy and the eventual parameters of application of the “serious, specific and consistent presumptions” method of proof.

• Civil judicial enforcement

Ensure the correct allocation of the buren of proof and compliance with the principle of legal certainty and effectiveness when constructing and applying a "system of proof" in the implementation of Article 4 Directive 85/374

1. Does Article 4 of the Directive preclude ‘a method of proof’ by which a court ‘may consider the facts relied on’ by Mr W as constituting ‘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’?

2. Should this ‘method of proof’ not be precluded by EU law, would ‘system of presumptions’ be allowed, whereby a causal link ‘would always be considered to be established when certain predetermined causation-related factual evidence is presented’?

3. Should the ‘system of proof’ be incompatible with EU law, must Article 4 of the Directive be interpreted as requiring established scientific evidence to prove the existence of a causal link between the alleged defectiveness of the vaccine and the damage suffered?

First and foremost, in its judgment, the Court recalled Article 4 of Directive 85/374: ‘the injured person will be required to prove the damage, the defect and the causal relationship between the defect and the damage’, however, due to the minimum harmonization character of the Directive, and according to the principle of procedural autonomy and 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 and according to which criteria and principles.

The Court stressed especially the importance of the principle of effectiveness, as a safeguard to the full exercise of the rights conferred by EU law.

Then the Court reiterated the importance of the allocation of the burden of proof: is for the national courts to ensure that the obligation to prove the existence of sufficiently serious, specific and consistent evidence in support to the plaintiff’s argument remains on the victim itself.

Therefore, as long as the correct allocation of the burden of proof remains intact, and as long as the procedural rules do not impair the full exercise of the rights of the consumer, the Court concluded that Article 4 in itself does not preclude a ‘method of proof’ such as the one adopted by the French legal system, as long as the burden of proof is not reversed.

With regard to the second question, the Court recalled once again the importance of the correct allocation of the burden of proof as well as the principle of legal certainty and effectiveness of the system of liability. The conclusion reached was that ‘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’ are to be considered incompatible with Article 4.

The referring Court, taking into account the instructions of the CJEU, applied the "method of proof" as interpreted in accordance with the principles of EU law. After having analysed the various factors and the scientific data available, it concluded that the "serious, specific and consistent presumptions" needed to establish a causal link between the product and the disease did not subsist. The appeal was consequently dismissed.

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

• Equivalence
• Effectiveness

The principle of equivalence was mentioned in relation to the relevance of the principle of procedural autonomy with regard to the possible incompatibility between national procedural rules and Directive 85/374

The Court recalled the principle of effectiveness in relation to the application both of Article 1 and 4 of Directive 85/374. In terms of the detailed procedural rules governing actions for safeguarding rights which individuals derive directly from EU law, the principle requires that those rules do not render practically impossible or excessively difficult the exercise of rights conferred by EU law.

Elements of judicial dialogue

• Direct dialogue between CJEU and National court (preliminary reference)

Preliminary reference

Determine potential incompatibility between national legislation and EU Law, specifically between Article 1 and 4 of Directive 85/374 and the articles of the French Civil Code transposing them.

Adopt the correct interpretation of the existing procedural rules regarding the proof of defects in products within B2C transactions, as to be compatible with Directive 85/374

Additional notes on the decision

In January 2018 the Sanofi case was used by the Court of Appeal of Bordeaux in support of its reasoning regarding a similar case. (Cour d’appel de Bordeaux 1e civ., 23 January 2018, 17-01816)