According to the Advocate General, Michal Bobek, addressing the Court of Justice of the European Union on Tuesday 7 March, it should be possible for a judge to consider that disease is a consequence of a vaccine on the sole basis of serious, specific and consistent presumptions, if there is an absence of scientific consensus.
This case (C-621/15) involves an individual who received vaccinations using a product developed by Sanofi Pasteur, against hepatitis B, between the end of 1998 and in the middle of 1999. In August 1999, the person in question began to display various symptoms, which in November 2000 were identified as multiple sclerosis. 11 months later the interested party passed away and the family of the deceased took matters to court in the belief that this disease was provoked by the vaccine.
The French Court of Appeal asked the Court of Justice to establish whether, despite the absence of scientific consensus, the judges could base their decision on “serious, specific and consistent presumptions” to establish the defectiveness of a vaccine and the causal link between the vaccine and the disease. The French judges held that there was no scientific certainty that there was a link between the vaccine in question and multiple sclerosis but that serious, exact and corroborating presumptions existed, given the excellent previous health of the applicant, the absence of a family history and the link in time between vaccination and the appearance of the disease.
The Advocate General considers that in principle, nothing should preclude a system of presumptions as a burden of proof. Although a European directive (on liability resulting from the product, 85/374/EEC) stipulates that proving damages due to defectiveness or an indicated cause is incumbent on the victim, the Advocate General held that it does not say anything about the rules governing proof, or requirements applicable in the area of proof. Therefore, this directive does not compel the judge to grant any particular weight to medical or scientific research.
According to the Advocate General, although scientific or medical proof is not necessarily required for establishing a causal link between a vaccine and disease, it does not mean that there is no need for a minimum burden of proof to be provided. On one hand, the burden of proof should be reversed. On the other, the presumptions should: 1) be based on an appropriate and sufficiently demanding body of proof; 2) be refutable (namely, that the adverse party can overturn the proof by using proof to the contrary); 3) not unduly restrict a coherent assessment of the evidence in question by a national judge; 4) not prevent the judge from taking into consideration any appropriate medical research that would be presented to them or imposing, as an absolute imperative, the presentation of medical research to demonstrate defectiveness or a causal link. (Original version in French by Jan Kordys)