SPAIN Law and Practice Contributed by: Xavier Moliner and Juan Martínez, Faus Moliner
The Judgments of 21 December 2020, and 21 and 28 January 2021 In these cases, the Supreme Court 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 author - ised the medicinal product, if applicable. The Supreme Court has clarified that, in such cases, liability must lie solely with the “producer” and, if applicable, with the authorities that authorised the product. The Supreme Court rejected any liability of the hospital, as the com - petence for monitoring the adequacy of such products relied on the competent authorities (not the hospital). The Supreme Court also pointed out that the hospital 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 concepts of “defective product” and “safety which may reason - ably 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 recommending that users of the affected pros - thesis follow a specific monitoring and control plan, and several months later voluntarily withdrew the product from the market. The Supreme Court pointed out that a manufacturer may be held liable under the product liability regime of RLD 1/2007 not only for damages caused by prod - ucts infringing safety and quality regulations but also for damages caused by products that, despite hav - ing undergone safety and quality controls, remain “unsafe”. The relevant time to determine whether a product is unsafe/defective is the time when the prod - uct is put into circulation. According to the Supreme Court, although the voluntary withdrawal of a product from the market does not necessarily mean that the product was defective at the time it was put into cir - culation, it may indeed constitute an indication that at that time the product did not comply with the safety standards that may reasonably be expected from it.
In the court proceeding, the manufacturer alleged that the prosthesis only had minor failures and that, in the majority of cases, it worked well in and accord - ance with its purpose. Furthermore, the manufacturer alleged that there was no proof that the damages were caused by the prosthesis itself, and stated that the withdrawal of the product from the market had been entirely voluntary. The Supreme Court did not accept these claims and considered that the fact that the prosthesis had an unexpectedly high rate of revisions must prevail. As per the Court, this high rate of revisions, which was neither identified nor disclosed by the manufacturer at the time the product was put into circulation (and, therefore, was not known by the medical community and the relevant notified bodies at that time), shows that the risks posed by the prosthesis were higher than expected. In these circumstances, the Supreme Court concluded that it falls on the manufacturer to prove why it was not possible to identify and disclose the true risks of the device (that ultimately caused the need to withdraw the product from the market) at the time the product was put into circulation. The Judgment of 24 January 2022 In this judgment, the Supreme Court confirmed the doctrine set forth in the Judgment of 20 July 2020 regarding liability for damages in corporate groups. The Supreme Court began by recalling that the gen - eral rule in Spain is to respect the concept of the sepa - rate legal personality of companies, meaning that: • each company is only liable for the fulfilment of the obligations it assumed and those arising from its own actions; and • belonging to a corporate group does not mean that a company may be held liable for acts carried out by other group companies. Although the doctrine of veil piercing allows the plain - tiff to sue a company other than that which performed the acts leading to the alleged damage, this is only possible on an exceptional basis. In order to apply such veil piercing, the plaintiff must prove that the company liable for the acts leading to the alleged damage was used abusively by another group com - pany for the very purpose of impeding future claims. In
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