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Roll up your sleeve – CJEU injects some influence in to vaccination case

19 December 2017. Published by Florence Page, Associate

The Court of Justice of the European Union (CJEU) has made a preliminary ruling on questions related to the admissibility of certain factual evidence in a product liability case.

In June 2017, the Court of Justice of the European Union (CJEU) made a preliminary ruling on questions related to the admissibility of certain factual evidence in a product liability case. The case was brought in the French courts against Sanofi Pasteur, the producer of a hepatitis B vaccine.  A link to the decision can be found here.

The claimant (Mr W) received the hepatitis B vaccine in December 1998, January 1999, and July 1999. In November 2000, Mr W was diagnosed with multiple sclerosis ("MS"). Mr W died in 2011.

In 2006, Mr W (and members of his family) brought proceedings against Sanofi Pasteur alleging that its hepatitis B vaccine was defective. The claimants referred to the lack of any family history of MS, and the short period of time between the vaccination and the diagnosis of MS. They argued that this factual evidence gave rise to a presumption of defect and a causal link between the injection and Mr W's MS.

The claimants won but the decision was subsequently appealed and overturned. The case was subject to further appeals, including to the Court of Appeal in Paris where it was noted that there was no scientific consensus as to a causal relationship between the vaccine and MS. 

A fresh appeal was brought before the Court of Cassation who referred three questions to the CJEU. The questions focussed on whether proof of defect and of the causal link between defect and damage can be established by factual evidence where there is no scientific consensus as to a causal link between a vaccine and a disease.

Key points from the CJEU ruling include:

  • The Product Liability Directive does not address how proof of defect is to be established by any given claimant. It is the responsibility of member states to determine, what evidence is admissible, methods by which such evidence can be obtained, and the level of proof required in line with the framework set out by the Product Liability Directive;
  • Methods of proof other than those based on medical research should not be excluded by national courts. To do so could place excessive burden on claimants in cases where there is said to be no medical consensus as to whether there is a causal link between the vaccine and the damage;
  • National legislature/national courts cannot introduce a method of proof which means that certain pre-determined factual evidence related to causation triggers an automatic presumption of a causal link between the vaccine and the damage; and
  • Factual evidence (such as that relied upon in the main proceedings of this case) can lead a national court to conclude that a claimant has discharged his/her burden of proof. However, the evidence must be sufficiently serious, specific, and consistent for such a conclusion to be drawn. Importantly, the courts must have regard to arguments and evidence presented by a producer in challenging the explanation put forward by the claimant. 

This preliminary ruling is not binding on courts in the UK, and does not reverse or change the burden of proof on claimants to establish defect, damage, and the causal relationship between the two, as set out in the Product Liability Directive. However, it does provide a useful insight into the kinds of factual evidence that the courts may be prepared to hear in product liability cases involving a vaccination, and the conclusions that may be drawn in the absence of solid scientific evidence from either side.