SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
2.17 Summary of Significant Recent Product Liability Claims Regarding product liability of medicinal products and medical devices, the following judgments of the Spanish Supreme Court deserve special mention. The Judgments of 21 December 2020, and 21 and 28 January 2021 In these cases, the Supreme Court has resolved different appeals for the unification of doctrine and case law regarding whether a hospital that has used a product whose toxicity is discovered and alerted after it has been used shall be liable for the injuries caused to the patient, or if such liability must only fall upon the “producer” and the competent authorities that authorised the medicinal product, if applicable. The Supreme Court has clarified that, in such cases, liability must lie solely with the “producer” and, if appli - cable, with the authorities that authorised the product. The Supreme Court rejected any liabil - ity of the hospital as the competence for moni - toring the adequacy of such products relied on the competent authorities (not the hospital). The Supreme Court also pointed out that the hospi - tal cannot be held liable for the risk created by allowing the use of the product, since that risk derives from the defective manufacture of the product. The Judgment of 1 March 2021 In this case, the Supreme Court ruled on the con - cepts of “defective product” and “safety which may reasonably be expected” with regard to a hip prosthesis that, after being commercialised, showed a revision rate higher than expected. Its manufacturer issued a safety notice recom - mending that users of the affected prosthesis follow a specific monitoring and control plan, and several months later voluntarily withdrew the product from the market.
ciation, as well as the general interests of con - sumers and users, without prejudice to the indi - vidual legal standing of the persons who have suffered the damages. When those damaged by a harmful event (eg, by a defective product) are a group of consumers or users that are perfectly determined or may be easily determined, the standing to apply for the protection of these collective interests cor - responds to: • associations of consumers and users; • legally constituted entities whose purpose is the defence or protection of such consumers and users; or • the affected groups themselves. In contrast, when those damaged by a harm - ful event are an undetermined number of con - sumers or users, or if the number is difficult to determine, the standing to bring court proceed - ings in defence of these collective interests shall correspond exclusively to the associations of consumers and users that form part of the Council of Consumers and Users. If the territorial scope of the conflict mainly affects one specific autonomous region, the specific legislation of that autonomous region shall apply. The Attorney General’s Office also has legal standing to bring any action in defence of the interests of consumers and users. Despite these procedural provisions, collec - tive actions and representative proceedings for product liability claims are not very common in Spain. Such claims are usually brought by indi - vidual plaintiffs.
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