Prodotti difettosi, danno da vaccino e onere della prova: la posizione della Corte di Giustizia

Article 4 of European Directive no. 85/374 states that the plaintiff shall be required to prove the defect of the product, the injury suffered, and the causal relationship between defect and injury. This rule poses several application concerns. In fact, it is unclear whether it is always necessary to give certain and irrefutable evidence of a defect in the product and of a causal link between the defect and the injury, or whether a serious, specific and consistent set of evidence allows the judge to infer that the existence of such a defect has been proven with a sufficiently high degree of probability. Recently, the Court of Justice, in a case of injury caused by a vaccine, has opted for an interpretation more favourable to the injured party, not only with regard to the proof of the defect, but also to the proof of a causal link between defect and injury, even if medical research neither confirms nor excludes the existence of a link between the two.