Link between the defect attributable to the vaccine

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Thus, the Court of Appeal rejected the arguments of temporal proximity and personal and family antecedents, in the absence of scientific evidence to support them. The preliminary question asked On a new appeal, the Court of Cassation decided to address the following preliminary questions: ) If Article of Directive / opposes the criminalization of pharmaceutical laboratories for vaccinations by proving the defect of the vaccine and the causal link between it and the disease, despite the lack of medical research in this regard? ) If the answer to the first question is in the negative, then does Article preclude criminalization based on the and the harm suffered when causation can be proved? ) If the answer to the first question is affirmative, then should Article be interpreted to mean that proof of causation must be scientifically proven? The Court's observations Directive / does not contain a definition of "causality" within the meaning of Articles and.

However, "defect" is defined in Article : defective product means "a product country email list which does not provide the legitimately expected safety, having taking into account all the circumstances" (case Novo Nordisk Pharma). Also, based on the principle of procedural autonomy and equivalence and effectiveness, the domestic legal order of each state must decide how to administer the evidence, what evidence is admissible, the probative force of the evidence or the necessary level of evidence (case Nike European Operations Netherlands). The principle of effectiveness requires the protection of the rights conferred by the legal order of the Union (the Steffensen case), in order not to prejudice the effectiveness of the directive.



In addition, an evidentiary regime that would exclude any recourse to an evidence-based method and would require the injured party to present definite proof would not comply with the objectives of the directive because it would raise the evidentiary requirement too high and exclude another mode of proof in outside of medical research. This requirement would also jeopardize ensuring a fair distribution of the risks inherent in modern technological production between the injured person and the producer. However, such an evidentiary regime must not be applied by the national court in a way that would work to the detriment of the manufacturer through unjustified presumptions.