The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, if necessary, provide the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by “serious, specific and consistent evidence” that would allow a judge, in the absence of certain and irrefutable scientific proof, to conclude the proof of the defect of the vaccine and of a causal link between the defect and the disease in question occurring.
Nonetheless, it is up to the victim to provide the burden of proof that the damages suffered, the defect in the vaccine and the causal link with the disease, as stipulated in the directive on responsibility, result from defective products (85/734/EEC).
This is the main substance of the decision made on Wednesday 21 June by the European Court of Justice (C-621/15), which was asked for its interpretation regarding a referral from the French Court of Cassation. The latter was approached in a case involving a person who died from multiple sclerosis that arose a few months after the interested party had been given the anti-hepatitis-B vaccine produced by Sanofi Pasteur.
The French judges ask whether, in such a case, in order to establish the responsibility of the pharmaceutical laboratory and given the provisions in the above-mentioned directive, which impose the burden or proof on the victim, the judge responsible for the case can consider, under the terms of their sovereign right to pass judgement, that the evidence (temporal proximity between the administering of a vaccine and the occurrence of a disease, the excellent health of the victim before vaccination, the absence of a family history) gathered by the family of the victim can constitute “serious, specific and consistent evidence” and prove that the defectiveness of the vaccine and the existence of a causal link between it and the disease, despite the fact that medical research has not established this kind of causal link.
In its ruling, the Court concludes the validity of this kind of system of proof and its compliance with the directive.
It points out that: the probationary system in question respects the demand of the directive imposing the burden of proof on the victim, insofar as it is up to the latter to establish the different areas of proof that, in combination, will enable the judge to be convinced of the existence of a defective vaccine and the causal link between it and damages suffered; when medical research does not help to establish such a causal link, the exclusion of any other kind of proof other than a certain proof provided in medical research would have the effect of making it extremely difficult, indeed, impossible to establish the responsibility of the manufacture of the vaccine. This kind of situation would compromise the effectiveness of the directive and its objectives (protecting the safety and health of consumers and fairly distributing the risks related to the production of vaccines between the victim and producer); - it falls to the national courts to check whether the evidence provided by the victim is sufficiently serious, specific and consistent to enable the judge, by taking into account the arguments presented by the producer as well, to establish whether the defective product is the most plausible cause of the damages suffered.
Finally, the Court adds that it is not possible for the national legislature or the national courts to introduce a method of proof under which the existence of a causal link between the defect attributed to a vaccine and the damage suffered by the victim will automatically be established when certain predetermined causation-related factual evidence is presented. This mode of proof would effectively undermine the rule on the burden of proof included in the directive and would deny the producer the possibility of producing factual elements and providing a defence of their arguments. It would also deny the judge responsible for the case any way of assessing the facts on the basis of these elements. (Original version in French by Francesco Gariazzo)