SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
2.10 Courts in Which Product Liability Claims Are Brought Product liability cases are usually brought before civil courts. In certain cases, product liability cas - es 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 damage suffered by the injured party. However, the producer’s civil liability for damages caused by defective products is subject to the following rules: • EUR500 will be deducted from the amount of compensation 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 approximately EUR63 million. 2.11 Appeal Mechanisms for Product Liability Claims In legal proceedings on product liability, it is pos - sible to file an appeal before the Court of Appeal against the judgment issued by the Court of First Instance. Against judgments on appeal rendered by the Court of Appeal, it is possible to file a cassa - tion appeal before the Supreme Court. This cas - sation appeal may be funded infringement of a procedural or substantive provision, provided that there is an interest in the cassation proceed - ings. The appeal will be considered 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
between the defect attributed to the vaccine and the damage suffered by the affected party will always be considered determined if certain pre - determined factual evidence is presented. In the five judgments issued between 2017 and 2019 by the National High Court (AN) regard - ing different liability claims filed in connection with human papillomavirus (HPV) vaccines, the Court confirmed that the burden of proving the defect, the damage and the causal relationship lies with the claimant and, 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, accord - ing to the Court, did not undermine 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 suffered being a consequence of the vaccine. Finally, the Court also rejected the liability of the phar - maceutical 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.
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