In an decision issued on Wednesday 21 June (Case C-621/15 - N.W, L.W, C.W v Sanofi Pasteur MSD SNC), the ECJ has attempted to grapple, in the pharmaceutical context, with the question of whether Member State laws that modify usual causative principles are compatible with the EU Product Liability Directive [85/374] regime.

The relevant reference to the ECJ was made in the context of a French case being brought against a pharmaceutical company in relation to an allegedly defective vaccination manufactured by it. The claimants relied on case law from the Cour de Cassation in France that stated that with specific regard to the liability of pharmaceutical companies for vaccines they had produced, proof of a causal link between the defect in the product and the damage suffered by the injured party could be presumed in certain circumstances, notwithstanding the science not being able to establish a causal relationship.

Article 4 of the Directive provides that “the injured person shall be required to prove the damage, the defect and the causal relationship between the defect and damage” [emphasis added]. The reference was brought in this context.

The ECJ concluded that:

  • The concept of a ‘casual relationship’ was not, like the concept of ‘defect’, strictly defined in the Directive – in this context it was for the relevant Member State court to determine (i) how evidence was to be elicited, (ii) what evidence would be admissible and (iii) the principles surrounding the probative value of evidence that was submitted.
  • The presumptive regime at hand did not change the burden of proof, and indeed, a regime that excluded “any method of proof other than certain proof based on medical research” would go too far the other way (i.e. make things too difficult for claimants).
  • As such, while a presumptive regime of the sort seen in this case was not contrary to Article 4 per se, it was incumbent on Member State courts, in each case, to ensure the evidence on which they were basing their presumption was sufficiently secure.
  • However, a Member State evidentiary rule that allowed presumptions as to causation to be made in a vaccine/disease scenario where despite the absence of medical proof one way or the other, a causal link was automatically established when “certain predetermined causation-related factual evidence is presented” did go too far and did breach Article 4.

In this judgment, the ECJ, while presentationally drawing a line in the sand regarding how far it was willing to let Member State courts and legislatures go on this causation question, has in reality probably drawn an artificial distinction. Whether one can really clearly distinguish systems of causal presumptions that work automatically from Member State evidential regimes that, while not working in the same automatic fashion, give courts a certain amount of leeway to use the evidence before them to prop up a presumption, remains to be seen.