Cassation: Civil Liability for Defective Drugs and Vaccines

1. The facts

   According to reports from Diritto e Giustizia, the Supreme Court of Cassation has issued a final ruling on an appeal by a patient who suffered severe adverse reactions after the administration of a diagnostic drug. The woman had sued the pharmaceutical company, claiming the medicine was inherently dangerous. However, both in the first instance and on appeal, the courts rejected the claim, noting that the specific reaction was expressly mentioned among the side effects in the patient information leaflet. The Cassation, in its ruling, confirmed the dismissal, holding that the adequacy of information provided to the consumer neutralizes the presumption of product defectiveness, even where the damage is significant.

2. 

   Relevant legal framework

   The case revolves around key provisions of the Consumer Code:

   1. Art. 114 establishes the manufacturer's strict liability for damages caused by defects in its product.
   2. Art. 117 defines a defective product as one that does not provide the safety that can be legitimately expected, considering the instructions and warnings provided.
   3. Art. 120 places the burden of proof on the injured party regarding the damage, the defect, and the causal link. The rule provides that the manufacturer can be exonerated by proving that the defect did not exist at the time of circulation or that scientific knowledge at the time did not allow it to be considered as such (the so-called development risk).

3. What the case law says

   Supreme Court case law has clarified that the safety of a drug does not coincide with its absolute harmlessness. Since pharmaceutical activity is inherently risky, the criterion for assessing defectiveness is the legitimate expectation of the informed consumer. The court specified that a clear, complete, and updated patient leaflet shifts the risk to the user, making the adverse event an accepted consequence of the medical treatment. Case law therefore excludes the manufacturer from being liable for every side effect, unless a manufacturing defect or a specific informational deficiency is proven to have misled the patient regarding the actual danger of the preparation.

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8. What it teaches professionals

   1. Leaflet analysis: the lawyer must first compare the medical record with the patient leaflet to check for the presence of the warning.
   2. Burden of proof: it is not enough to allege the causal link between ingestion and damage; one must identify the specific design or manufacturing defect.
   3. Scientific timeliness: it is essential to verify whether, at the time of administration, new scientific evidence existed that should have required the manufacturer to immediately update the warnings, overcoming the development risk defense.

References: Art. 114 Codice del ConsumoArt. 117 Codice del ConsumoArt. 120 Codice del Consumo

Editorial oversight: Avv. Federico Papa·ICAMUpdated 6 September 2026Content drafted with AI support and subject to editorial source checks. Despite these controls, inaccuracies may remain: reports and rectification requests are welcome. Report a correction