SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
precisely to prevent damage (as stated in the explanatory part of the Directive, for exam - ple a warning mechanism such as a smoke detector, the possible non-fulfilment of this purpose by the product. Finally, like the previ - ous regulation, the new Directive establishes that in no case will a product be considered defective because a better product or an improved or updated version of it is subse - quently placed on the market. With regard to this last element, it should be recalled that, in the field of medicinal products, the informa - tion provided in the summary of product char - acteristics 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 defec - tive will not cease to offer the “safety that can legitimately be expected” simply because its summary of product characteristics 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 judgment of 24 November 2011, in relation to Zyprexa®). • A new system of disclosure of evidence and presumptions, which aims to make it easier for the claimants to prove the defect and the causal link in complex cases. • A new expanded list of responsible parties. In the case of defective products or com - ponents whose manufacturer is established outside the EU, the authorised representa - tive of the manufacturer will also be liable alongside the importer; and, where there is no importer established in the EU or 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 distributor of the defective product (and the provider of an online platform that allows con - sumers 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: (i) the injured party requests the distribu - tor (or the provider of the online platform) to identify the economic operator established in the EU responsible, or the distributor who supplied the product to them, and (ii) the distributor (or the provider of the online plat - form) 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 dam - age, 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 economic operators respon - sible. • The new rules on limitation and expiry peri - ods. 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 limitation 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 identity of the economic operator who may be held liable. This limitation period may be interrupted in accordance with the applicable rules of national law. On the other hand, the ten-year expiration period remains in force. Once this period has elapsed sub -
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