Product Liability and Safety_2026

SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner

Proximate Causation Occasionally, Spanish courts also accept that the causal relationship may be proven by means of pre - sumption or circumstantial evidence. An example is the judgment of 21 October 2025 delivered by the Bar - celona Court of Appeal in a case concerning allegedly defective hip prostheses. In that decision, the court held that, where it is not possible to clearly deter - mine the precise cause of the damage or to reason - ably exclude alternative explanations, a product may nevertheless be regarded as defective on the basis of indirect evidence or judicial presumptions. In Spain, the principle of generic causation (ie, in order to prove the causal relationship, it would be enough to demonstrate that a product is capable of causing the alleged injury) is not applied. Spanish courts have ruled that the mere fact that a product can cause dam - age 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 prod - uct. It is sufficient that the claimant proves the exist - ence 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 considered defective under the proximate causation principle. In these particu - lar cases, the CJEU concluded that Directive 85/374/ CEE on damages 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 pacemak - ers and cardioverter defibrillators are particularly high, considering their purpose and the vulnerability of the patients who use them. Under these circumstances, 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 necessary to prove the exist - ence of the defect in each particular unit, as they are products of the same model and production series.

• prove that the document is not available to them and prove the impossibility of obtaining it; • prove that the document refers to the subject of the process (because it is documentary evidence relevant to the case) or to the effectiveness of other means of proof (because it gives, or does not give, effectiveness to other evidence presented); and • provide a photocopy or simple copy of the docu - ment, or indicate its content in the most exact terms. 2.8 Rules for Expert Evidence in Product Liability Cases In this type of proceeding, the litigants are responsi - ble for proposing the examination of expert evidence. The only restriction regarding its nature and scope is that it must be necessary to have scientific, artistic, technical or practical knowledge to ascertain any facts or circumstances that are relevant to the matter or to acquire certainty about them. The parties are allowed to present their own evidence and bring their own technical specialists, and/or to request the court to appoint any technical specialist in order to assess the evidence presented by the par - ties or ascertain any facts or circumstances that are relevant to the matter of the case. Generally, in this kind of proceeding, the court may not ex officio propose the examination of expert evidence nor appoint technical specialists in order to assess the evidence presented by the parties. However, in exceptional cases, once the proceedings have been concluded and before judgment is rendered, the court may ex officio order the examination of new evidence (including expert evidence) on relevant facts if the evi - dence 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 prov - ing the existence of the defect, the damage and the causal relationship between them upon the claim - ant. To establish such causal relationship, the claim - ant must provide solid and substantial evidence that supports such a link and proves that damages are an appropriate and sufficient result of the defect.

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