SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
Proving Liability When Medical Research is Inconclusive On 21 June 2017, the CJEU issued another decision (C-621/15) referring to the product liability of manu - facturers whose products have a defect that poses a risk to the consumer. In these circumstances, the Court decided that European law does not preclude a national court from considering – when medical research does not establish or reject a relationship between the vaccine and the occurrence of a dis - ease – that some facts alleged by the injured person constitute serious specific and consistent evidence enabling the court to conclude that there is a defect in the vaccine and that there is a causal link between that defect and the disease. On the other hand, the Court also ruled that judges should ensure they do not reverse the burden of proof when applying this evidence regime. According to the Court, the Directive precludes rules based on pre - sumptions in which medical research neither estab - lishes nor rules out the existence of a link between the vaccine and the disease. The existence of a causal link between the defect attributed to the vaccine and the damage suffered by the affected party will always be considered determined if certain predetermined factual evidence is presented. In the five judgments issued between 2017 and 2019 by the National High Court (AN) regarding different lia - bility claims filed in connection with human papilloma - virus (HPV) vaccines, the Court confirmed that the bur - den of proving the defect, the damage and the causal relationship lies with the claimant; in the absence of evidence from the claimant, the Court absolved the Ministry of Health and the pharmaceutical company of all wrongdoings attributed to them. The AN rejected the evidence proposed by the claimants, consisting of opinions that, according to the Court, did not under - mine the studies and clinical trials that endorsed the efficacy of the product. With respect to the alleged lack of informed consent prior to its administration, the AN rejected the complaints because the claim - ants had not proven that the pathologies they were diagnosed with were a frequent adverse reaction, and therefore the obligation to inform did not include this risk since it was not known. Moreover, the AN considered that the causal relationship between the
diagnosed diseases and the vaccines had not been proven, as the medical history did not point to the ailments and symptoms from which the claimants suf - fered being a consequence of the vaccine. Finally, the Court also rejected the liability of the pharmaceutical companies for defect of information in the summary of product characteristics and the leaflet on the basis that the claimants had not proven that their diseases were caused by the vaccine. 2.10 Courts in Which Product Liability Claims Are Brought Product liability cases are usually brought before civil courts. In certain cases, product liability cases are also brought before administrative courts when, jointly with damages actions on product liability, the claimant brings actions against the public administration. All these cases shall be resolved by judges. The amount of compensation will depend on the dam - age suffered by the injured party. However, the pro - ducer’s civil liability for damages caused by defective products is subject to the following rules: • EUR500 will be deducted from the amount of com - pensation for material damage; and • the global civil liability of a producer for death and personal injury caused by identical products that present the same defect will be limited to approxi - mately EUR63 million. 2.11 Appeal Mechanisms for Product Liability Claims In legal proceedings on product liability, it is possible to file an appeal before the Court of Appeal against the judgment issued by the Court of First Instance. It is possible to file a cassation appeal before the Supreme Court against judgments on appeal rendered by the Court of Appeal. This cassation appeal may be funded infringement of a procedural or substan - tive provision, provided that there is an interest in the cassation proceedings. The appeal will be consid - ered to have a cassation interest when the decision appealed against in cassation opposes the case law of the Supreme Court, or resolves points and issues on which there is contradictory case law of the Appeal Courts, or applies rules for which there is no case law
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