Must Article 4 of Council Directive 85/374/EEC (1) of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products be interpreted as precluding, in the area of liability of pharmaceutical laboratories for the vaccines that they manufacture, a method of proof by which the court ruling on the merits, in the exercise of its exclusive jurisdiction to appraise the facts, may consider that the facts relied on by the applicant constitute serious, specific and consistent presumptions capable of proving the defect in the vaccine and the existence of a cau ...[+++]sal relationship between it and the disease, notwithstanding the finding that medical research does not establish a relationship between the vaccine and the occurrence of the disease?

By the first ground of appeal, the appellants claim that the General Court attributed to them the anti-competitive conduct of SKW Stahl-Technik GmbH Co. KG (‘SKW’) in breach of the range of the attribution of liability under Article 81 EC (now Article 101 TFEU), the principle of personal responsibility, the presumption of innocence and the principle that liability presupposes fault by rejecting the rebuttal of the presumption of decisive influence.

This identifies the sole objective of the safety investigation and indicates that a safety recommendation shall in no case create a presumption of liability or blame and that the report has not been written, in terms of content and style, with the intention of it being used in legal proceedings.

Furthermore, it is foreseen that the supplier can refute the presumption of liability by duly justifying his shortcoming to the competent tax authority.