ITALY Trends and Developments Contributed by: Maria Rosa Galletti, Silvio Severino and Simone Esposito Cordani, RASS – Studio Legale Rinaldi e Associati
identified, no amalgamation of provisions from different regimes is permitted. The Court decision also provides an interpreta - tive overview of the three sets of rules govern - ing the liability of the manufacturer of medicinal products, as follows. Liability for defective products Liability for defective products, governed by the Consumer Code, is presumed. Under Article 120 of the Consumer Code, the injured party must only prove the damage, the defect and the causal link. With regard to the latter two elements, proof may be established through serious, precise and consistent circum - stantial evidence. Conversely, the manufacturer bears the burden of proving facts that would exclude its liability. A central concept in this regime is that of a (non-) defective product, as defined in Article 117 of the Consumer Code. A product will not be con - sidered defective if it cumulatively: (i) complies with the relevant regulatory standards; and (ii) corresponds to the legitimate expectations of consumers regarding its intended use. With regard to point (ii), the manufacturer must provide adequate information about the product at the time it is placed on the market. Once this duty has been fulfilled, the principle of consumer self-responsibility applies. However, the mere provision of generic information regarding the dangerousness of the product does not exoner - ate the manufacturer from liability. In this regard, the Court recalls its previous decision (Judgment No 12225/2021), according to which the manu - facturer’s liability “is not excluded merely by proof of having provided, by means of the prod-
uct information leaflet (the so-called bugiardino), a general warning about the product’s lack of safety; rather, such a warning must enable the consumer to make an informed assessment of the risks and benefits and to take all necessary precautions to prevent harm, thereby exposing themselves to the risk voluntarily and knowingly” . The Court further specifies that, in the case of vaccine administration, such information may also include, for example, interactions between the vaccine and other medicinal products. More generally, in order to provide the most complete information, the manufacturer must diligently gather all scientific data available up to the time the product is placed on the market. This obliga - tion requires the acquisition of all available tech - nical knowledge, even at significant cost. Regarding the evidence excluding liability avail - able to the manufacturer, it may validly be pro - vided – insofar as it is relevant – in two cases (under Article 118 of the Consumer Code): (i) if the defect did not exist at the time the product was placed on the market; or (ii) if, according to the state of scientific and technical knowledge available at that time, the product could not have been considered defective. Liability for the exercise of dangerous activities Liability for the exercise of dangerous activities, set out in Article 2050 of the Italian Civil Code, is characterised by its almost strict (or quasi- objective) nature due to the high degree of inher - ent risk. In this case, the manufacturer must remain con - stantly updated on the state of scientific knowl - edge; this obligation therefore extends beyond the time the product is placed on the market.
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