Court Of Justice Of European Union Lowers Evidence Standard In Vaccine-Liability Case

On 21 June 2017, the Court of Justice of the European Union (the "ECJ") ruled on a request for a preliminary ruling from the French Supreme Court (Cour de cassation) on the burden of proof faced by patients who have suffered harm from a defective vaccine. The ECJ decided that the defect of a vaccine and the causal link between this defect and a disease can be demonstrated by serious, specific and consistent evidence, in the absence of scientific consensus about a causal relationship (ECJ, 21 June 2017, Case C-621/15, N.W, L.W en C.W v. Sanofi Pasteur MSD SNC, Caisse primaire d'assurance maladie des Hauts-de-Seine and Carpimko).

The background of the request is as follows: Mr. W was injected with a vaccine against hepatitis B. A year later, Mr. W started presenting various symptoms leading to the diagnosis of multiple sclerosis. Mr. W and his family brought proceedings seeking compensation for the damage caused to him by the vaccine on the basis of Article 1386 (currently Article 1245) of the French Civil Code. However, the Paris Court of Appeal held that there was no scientific consensus regarding a causal link between the vaccination against hepatitis B and the occurrence of the disease. On appeal, the French Supreme Court requested the ECJ to interpret Article 4 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (the "Directive"). The French Supreme Court sought to know whether that provision stands in the way of national evidentiary rules under which a court may consider that, notwithstanding the finding that 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, specific factual evidence relied on by the applicant could constitute serious, specific and consistent evidence in support of the conclusion that there is a defect in the vaccine and that there is a causal link between that defect and that disease.

Under Article 4 of the Directive, a person injured by a defective product should prove the damage, the defect and the causal relationship between defect and damage. The ECJ noted that while under the Directive the burden of proof rests on the victim, the Directive does not address how this burden must be met. Hence, the ECJ found that an evidentiary rule based on serious, specific and consistent...