SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
the evidence already examined is found to be insufficient. In practice, this is very unusual. 2.9 Burden of Proof in Product Liability Cases The product liability regime places the burden of proving the existence of the defect, the damage and the causal relationship between them upon the claimant. To establish such causal relation - ship, the claimant must provide solid and sub - stantial evidence that supports such a link and proves that damages are an appropriate and suf - ficient result of the defect. Proximate Causation Nonetheless, occasionally, Spanish courts also accept that the causal relationship may be prov - en by means of presumption or circumstantial evidence. In Spain, the principle of generic causation (ie, in order to prove the causal relationship, it would be enough to demonstrate that a prod - uct is capable of causing the alleged injury) is not applied. Spanish courts have ruled that the mere fact that a product can cause damage is not enough to determine the defective nature of that product; in order to prove that a product is defective, the claimant must prove that the damages suffered are effectively caused by the defective product. It is sufficient that the claim - ant proves the existence of a defect, but it is not strictly necessary that the claimant provides evidence of the specific defect of the product. It can, therefore, be concluded that the proximate causation principle operates in Spain. Defective Batches/Series of Products On 5 March 2015, the CJEU issued a ruling on joined cases C-503/13 and C-504/13, under which certain kinds of products can be consid - ered defective under the proximate causation
principle. In these particular cases, the CJEU concluded that Directive 85/374/CEE on dam - ages caused by defective products shall be interpreted in a manner sensitive to the particular product in question. The security requirements that patients can expect from products such as pacemakers and cardioverter defibrillators are particularly high, considering their purpose and the vulnerability of the patients who use them. Under these circumstances, as they are prod - ucts of the same model and production series, after a defect has been detected in a unit, the other units of the same model or batch can be classified as defective without it being neces - sary to prove the existence of the defect in each particular unit. Proving Liability When Medical Research is Inconclusive On 21 June 2017, the CJEU issued another deci - sion (C-621/15) referring to the product liability of manufacturers whose products have a defect that poses a risk to the consumer. In these cir - cumstances, the Court decided that European law does not preclude a national court from con - sidering, when medical research does not estab - lish or reject a relationship between the vaccine and the occurrence of a disease, 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 presumptions in which medical research neither establishes nor rules out the existence of a link between the vaccine and the disease. The existence of a causal link
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