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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.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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