ITALY Trends and Developments Contributed by: Maria Rosa Galletti, Silvio Severino and Simone Esposito Cordani, RASS – Studio Legale Rinaldi e Associati
Evidence excluding liability is validly provided only if the manufacturer demonstrates that it took all possible measures to prevent the dam - age, and yet the damage occurred as a result of a fortuitous event. It is not sufficient to prove mere compliance with technical standards or the generic fulfilment of the duty to provide informa - tion. Liability for tortious acts Liability for tortious acts, set out in Article 2043 of the Italian Civil Code, may also be invoked by the consumer. In this case, the consumer has the burden of proving all the following elements: the fact, the causal link, the fraud (or negligence) and the damage. It should be noted that the possibility for con - sumers to invoke any of the aforementioned liability regimes is also expressly recognised by the PLD – similarly to Directive (EEC) 85/374 – under Article 2, paragraph 4, letters (b) and (c). However, the Court rejects the possibility of “blending” the different regimes of liability. A ruling that takes an opposing view A ruling that takes the opposite view, at least with regard to the liability regime applicable to the pharmaceutical manufacturers, is Court Order No 33984/2025 of 23 December 2024. This case concerned an appeal brought by an individual alleging he was injured by the use of dental paste. His claim was rejected by the Court of Appeal. The appeal was upheld, and the case was remitted to the Court of Appeal. Two key points of the Court’s decision are as follows.
• The manufacture of pharmaceuticals is a haz - ardous activity and falls within the scope of Article 2050 of the Civil Code – quasi-objec - tive liability applies. There is an obligation to provide information that is as comprehensive and specific information as possible, con - stantly updated in light of the latest scientific knowledge. Specifically, in the subject case, the manufacturer should have warned con - sumers (in the package leaflet) of the foresee - able consequences of excessive use of the dental paste. • The causal link between the defect and the damage is not interrupted by the careless but entirely foreseeable conduct of the injured party – especially if the manufacturer was aware of scientific studies highlighting the harmful effects of the product. In conclusion, according to Court’s recent case law, the issue of pharmaceutical manufacturers’ liability requires a case-by-case assessment of the applicable legal framework. Each case demands a reasonable balance between the manufacturer’s duty to inform and the principle of consumer self-responsibility. The EU Court of Justice Expands the Concept of Supplier Liability Through the judgment of 19 December 2024 (case C-157/23 - Ford Italia S.p.A. v. ZP and Stracciari S.p.A.), the Court of Justice of the European Union (CJEU) has significantly broad - ened the supplier liability, following an unprec - edented interpretation of Directive (EEC) 85/374. It should be specified that the CJEU’s decision also applies to the PLD, which, for the purposes of this analysis, reproduces (in Article 4, para - graph 10, letter b)) the provisions of the repealed Directive (EEC) 85/374.
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