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Italy – Product liability: important decision of the Milan Courts on defective medical devices

The protection of consumers damaged by defective products was introduced into the EU framework by Directive No. 374/1985/EEC (the "Directive") and implemented in Italy by Presidential Decree No. 224/1988, subsequently incorporated into Legislative Decree No. 206/2005 (the so called "Codice del Consumo", the "Code"). The Directive intervened to coordinate and harmonise national legislation and to avoid that the existing disparities among domestic regulations could adversely affect competition, thus jeopardising the free circulation of goods within the common market. Product liability regulation has often been invoked by patients dissatisfied with the performance or durability of implanted medical devices.

By decision No. 723, dated January 27th, 2020, the Court of Milan, ruling on a product liability case concerning defective medical devices, took the opportunity to review some of the core principles arising from Sections 117 et seq. of the Code.

According to the above-mentioned decision, in order to assess a manufacturer's liability, the existence of a damage suffered by the consumer is not per se unequivocal evidence of the defective nature of the product. Therefore, in order to ascertain the defectiveness of the product, the mere proof of damage is not sufficient, but it shall be investigated whether or not the damage is a consequence of the failure by the product to satisfy the required safety standards.

As a consequence, the damage suffered by the consumer does not per se prove, either directly or indirectly, the defectiveness or the dangerousness of the product under normal conditions of use, but it proves only a generic dangerousness of the product itself, which is insufficient to determine manufacturer's liability under the Code. The judgement of safety/defectiveness of the product cannot be inferred from deductive evaluations, but, instead, it must be based on rigorous assessments and evaluations.

The Court of Milan also underlines that the above-mentioned liability is grounded on the existence of a causal link between defects and damages, irrespective of an assessment of manufacturer's culpability.

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