ITALY Trends and Developments Contributed by: Maria Rosa Galletti, Silvio Severino and Simone Esposito Cordani, RASS – Studio Legale Rinaldi e Associati
Recent Guidelines From the Italian Supreme Court on the Liability of Pharmaceutical Manufacturers The Italian Supreme Court (the “Court” ) recently ruled on the liability of pharmaceutical manufac - turers. It should be noted that, over the years, the Court gave different, and sometimes ambigu - ous, interpretations in this area, particularly with regard to the applicable liability regime. Such diversity of interpretation will also emerge from the analysis of the judgments discussed herein. Through Judgment No 8224 of 28 March 2025, the Court ruled on the appeal brought by a phar - maceutical company against a judgment of the Court of Appeal of Lecce. In 2021, the Court of Appeal of Lecce ruled that the Pharmaceutical Company had to pay compensation for dam - ages caused by a flu vaccine. The Pharmaceu - tical Company challenged that ruling, alleging a misinterpretation of the legislation governing pharmaceutical product liability. According to the appellant, the Court of Appeal of Lecce had made an inadmissible “patchwork” by combin - ing Consumer Code (containing general prod - uct liability and safety rules), Article 2043 of the Italian Civil Code (on compensation for unlaw - ful acts) and Article 2050 of the same Code (on liability for the exercise of dangerous activities). The Court upheld the appeal and remitted the case to the Court of Appeal of Lecce, setting out the following principle of law. The rules governing liability for defective prod - ucts under the Consumer Code, based on Directive (EEC) 85/374 – where the PLD does not apply, ratione temporis – do not preclude an injured party from seeking protection under other liability regimes provided by Articles 2043 and 2050 of the Italian Civil Code. However, once the applicable liability regime has been
Lastly, according to paragraph 4, the judge may presume the existence of defectiveness, the causal link or both, notwithstanding proper ful - filment of the disclosure by the manufacturer, if: • the claimant “faces excessive difficulties, in particular due to technical or scientific com - plexity, in proving the defectiveness of the product or the causal link between its defec- tiveness and the damage, or both” ; or • the claimant demonstrates “that it is likely that the product is defective or that there is a causal link between the defectiveness of the product and the damage, or both” . In any event, the defendant’s right to submit contrary evidence is granted. It is worth briefly considering civil liability for damages resulting from AI systems, with a glance at the Italian context. In this respect, recently, the European Commission withdrew its proposed AI Liability Directive. Therefore, the only legislation applicable to AI remains the PLD (which covers AI systems) and Regulation (EU) 2024/1689 (the “AI Act” ). There is no doubt the providers (within the meaning of the AI Act) are also to be regarded as manufac - turers under the PLD. In Italy, in March 2025, the Senate approved Draft Law S 1146 (the “AI Draft Law” ), which governs AI across various sectors but does not deal with liability. As a result, AI-related liability for damages con - tinues to be governed by domestic general pro - visions – ie, Articles 2049, 2050 and 2051 of the Civil Code and the Consumer Code – while we await receipt of the PLD in the Italian legal sys - tem.
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