Product Liability and Safety_2026

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

Disclosure of evidence A new system of disclosure of evidence and presump - tions aims to make it easier for the claimants to prove the defect and the causal link in complex cases. New expanded list of responsible parties In the case of defective products or components whose manufacturer is established outside the EU, the authorised representative of the manufacturer will also be liable alongside the importer; where there is no importer established in the EU or no authorised representative, the logistics service provider will be liable. Any natural or legal person who substantially modifies a product outside the manufacturer’s control and subsequently markets or puts it into service will also be considered the manufacturer of the product for the purposes of the new Directive. The distribu - tor of the defective product (and the provider of an online platform that allows consumers to enter into distance contracts with traders) may also be liable when neither the manufacturer, the importer of the product or component, the authorised representative nor the responsible logistics operator is identified if the injured party requests the distributor (or the pro - vider of the online platform) to identify the economic operator established in the EU responsible, or the dis - tributor who supplied the product to them, and the distributor (or the provider of the online platform) does not identify the economic operator within one month of receiving such a request. In any case, where two or more economic operators are responsible for the same damage, they shall be jointly and severally liable to the injured party. However, the economic operator who is jointly and severally liable for compensation shall be entitled to recourse against the other eco - nomic operators responsible. New rules on limitation and expiry periods The limitation period for bringing product liability actions will continue to be three years. As a novelty, the new Directive establishes some modifications regarding the rules for its computation: the limita - tion period will start to run from the day on which the injured party becomes aware (or should reasonably have become aware) both of the damage and of the defective nature of the product, as well as of the iden - tity of the economic operator who may be held liable.

composition and packaging, and instructions for its assembly, installation, use and maintenance; • the reasonably foreseeable use of the product; • the effect on the product of any ability to continue to learn or acquire new features after it is placed on the market or put into service; • the reasonably foreseeable effect that may be caused by other products that are expected to be used with the product (also by interconnection); • the precise time when the product was placed on the market; • the relevant product safety requirements (including cybersecurity requirements); • any recall of the product and/or any other interven - tions made by a regulatory authority or an econom - ic operator responsible for the product in relation to its safety; • the specific needs of the group of users for whom the product is intended; and • in the case of a product whose very purpose is precisely to prevent damage (as stated in the explanatory part of the Directive – eg, a warning mechanism such as a smoke detector), the possi - ble non-fulfilment of this purpose by the product. Finally, like the previous regulation, the new Direc - tive establishes that in no case will a product be considered defective because a better product or an improved or updated version of it is subsequently placed on the market. With regard to this last ele - ment, it should be recalled that, in the field of medici - nal products, the information provided in the summary of product characteristics and the package leaflet is regularly updated on the basis of the latest available data. Thus, a medicinal product that at the time it is marketed is not considered defective will not cease to offer the “safety that can legitimately be expected” simply because its summary of product characteris - tics and package leaflet are updated at a later date, including, for example, new warnings, risks or adverse effects (see the judgment of the Barcelona Provincial Court of 18 April 2008 in relation to Agreal® or the judgment of the Madrid Provincial Court in its judg - ment of 24 November 2011, in relation to Zyprexa®).

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