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In brief

With judgment No. 12225 published on 10 May 2021, the Council of State ruled that generic warnings reported in the package leaflet of an authorized medicinal products do not exclude the manufacturer’s liability under the Consumer Code.


What’s New 

In this regard, the Court stated that, for the purposes of excluding liability, it is not sufficient to publish information allowing the patient to gain a generic awareness about the possible occurrence of the danger indicated in the package leaflet it being necessary to provide a specific warning through which consumers can make a correct assessment of the risks and benefits associated with the use of the drug, take all necessary precautions to avoid the occurrence of the damage and, therefore, voluntarily and consciously expose themselves to risks.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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