SPAIN Trends and Developments Contributed by: Gonzalo Ardila, Margarita Morales, Fátima Mallén and Alberto Witzl, Hogan Lovells Cadwalader
uct references played a decisive role in the Court’s assessment of defectiveness. It is precisely at this point that the judgment warrants critical reflection. Post-market surveillance is a funda- mental element of the regulatory framework governing medical devices and is intended to identify risks that may not have been detectable during the pre-market stages. There is therefore a risk that actions driven by regulatory prudence may subsequently be used as retrospective evidence of an original defect. Para- doxically, the more robust the surveillance systems and the more diligent the manufacturer’s response, the greater its potential exposure to future claims. This issue is far from insignificant. Although the Supreme Court insists that a product recall does not automatically establish defectiveness, the combina- tion of the inability to examine the specific unit and the importance attributed to post-commercialisation safe- ty measures appears to substantially raise the eviden- tiary threshold that manufacturers must meet to rebut an inference of defectiveness. The practical effect is an approach that comes close to a quasi-strict liability regime in cases involving product recalls or field safety corrective actions. This is particularly relevant in the medical device sector, where such measures are a normal feature of post-market surveillance systems and do not, in themselves, constitute an admission of an original defect. The implications for product liability insurance are especially significant. The growing importance that the judgment attaches to recalls and safety corrective actions as evidentiary elements increases uncertainty regarding insured exposure and complicates the ex- ante assessment of risk. It is entirely conceivable that this may lead to stricter underwriting conditions and greater scrutiny of the temporal scope of coverage. For medical device manufacturers, the judgment also serves as a warning regarding litigation and eviden- tiary strategy. The preservation of technical evidence, proper documentation of risk assessments, and the traceability of decisions taken throughout the prod- uct life cycle may prove decisive in future proceed- ings. Likewise, it would be prudent to review product liability insurance programmes on a regular basis to
ensure that coverage adequately addresses scenarios in which subsequent regulatory actions acquire deci- sive importance in litigation. In conclusion, Supreme Court Judgment (STS) 678/2026 introduces an additional layer of uncertainty into product risk management. The significance attrib- uted to product recalls and safety corrective actions as indicators of defectiveness may reduce the pre- dictability of insured exposure and, in practice, move defective product liability closer to a quasi-strict liabil- ity regime in certain circumstances. The Blackout as a Source of Litigation On 28 April 2025, a major power blackout occurred, affecting virtually the entire Spanish mainland – as well as Portugal – leaving millions of consumers and businesses without electricity for several hours and triggering an unprecedented wave of claims against insurance companies. The losses resulting from the interruption of the power supply are highly diverse, including: • damage to electronic equipment and industrial machinery; • spoilage of perishable goods due to the disruption of refrigeration chains; • business interruption losses and the resulting loss of profit; • failures of IT and communications systems; and • damage in particularly sensitive sectors such as healthcare and transport. The scale of the event and the large number of affect- ed parties have placed insurers in an exceptional situation, putting significant pressure on the ordinary mechanisms for claims handling and loss adjustment. Although litigation arising from electricity supply dis- ruptions is not new within the Spanish legal system, its scale changes dramatically when the interruption results from a widespread systemic failure. In such cases, the simultaneous concentration of thousands of claims, the variety of losses being asserted and the complexity of the potentially applicable insurance coverages create a situation particularly prone to dis- putes. Disagreements regarding the scope of policy coverage, the quantification of losses, or the applica-
219 I NSURANCE L I T IGATI O N 2026
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