Identified only by his initials in the ruling, JW underwent the Sanofi Pasteur vaccination against hepatitis B between the end of 1998 and the middle of 1999. Though he was in excellent health before that point, JW began began to experiencing various symptoms by August 1999 and was diagnosed the following year with multiple sclerosis.
When JW died in October 2011, he and his family were five years into a legal battle to hold the drugmaker liable.
Though the regional court in Nanterre initially upheld the action, the Paris Court of Appeal dismissed the case in 2011, finding no scientific consensus supporting a causal relationship between the vaccination against hepatitis B and the occurrence of multiple sclerosis.
On further appeal, the French Court of Cassation invited the European Court of Justice to clarify the EU directive on liability for defective products.
Turning the tide against Sanofi Pasteur this morning, the court in Luxembourg says the directive should be interpreted to allow national evidentiary rules that allow trial courts to consider “serious, specific and consistent evidence,” notwithstanding the absence of relevant medical research, that would support the conclusion that there is a defect in the vaccine and that there is a causal link between that defect and that disease.
By excluding any method of proof other than certain proof based on medical research, the ruling warns, courts could be creating too-high an evidentiary standard, making “it excessively difficult … or … impossible to establish producer liability.”
This is especially true in a case like this “where it is common ground that medical research neither confirms nor rules out the existence of such a causal link,” the ruling states.
In the case at hand, sufficient proof would include “the temporal proximity between the administering of a vaccine and the occurrence of a disease and the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered,” according to the ruling.
“That could be the case inter alia where that evidence leads the court to consider, first, that the administering of the vaccine is the most plausible explanation for the occurrence of the disease and, second, that the vaccine therefore does not offer the safety that one is entitled to expect, taking all circumstances into account, as provided for in Article 6 of that directive, because it causes abnormal and particularly serious damage to the patient who, in the light of the nature and function of the product, is entitled to expect a particularly high level of safety,” the ruling continues.
The court cautioned national courts to ensure nevertheless “that their specific application of those evidentiary rules does not result in the burden of proof introduced by Article 4 being disregarded or the effectiveness of the system of liability introduced by that directive being undermined.”