Damage from Lack of Informed Consent: Burden of Proof and Self-Determination Rights

1. The fact

   The case stems from a surgically flawless procedure preceded by inadequate information regarding collateral risks. According to reports from outlets such as Quotidiano Sanità and Guida al Diritto, a patient complained of worsening living conditions due to a specific complication. Although this was a known risk of the procedure, it had not been communicated.

   The case reached the Supreme Court after the lower courts dismissed the claim for compensation, noting the absence of any technical error. At the heart of the dispute is not malpractice, but the violation of the patient's freedom to refuse treatment involving risks that were not previously accepted.

2. 

   The norms at play

   The legal foundation lies in Law 219/2017, where Article 1 stipulates that no medical treatment can be initiated without free and informed consent. At the constitutional level, Article 13 on personal liberty and Article 32 on health protection are involved.

   From a civil law perspective, contractual liability is framed under Article 1218 of the Civil Code for breach of information duties. Crucially, Article 2697 of the Civil Code regulates the burden of proof: the injured party must prove not only the omission, but also the concrete prejudice caused by the lack of information.

3. What jurisprudence says

   Case law from the Supreme Court has clarified that the right to self-determination is an autonomous legal right, distinct from the right to health. Consequently, a physician's failure to inform properly can ground liability for damages even if the surgery was technically flawless.

   However, the courts have established a strict evidentiary standard: the patient bears the burden of counterfactual proof. They must demonstrate, including through presumptions, that had they been informed of the risks, they would have reasonably refused the intervention based on their personal history and values.

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8. What it teaches professionals

   1. Customization of consent: A pre-printed form is not enough; the clinical dialogue must highlight specific risks related to the patient's professional activity and lifestyle.
   2. Evidentiary records: The facility and the physician must ensure documentation proving that comprehensive information was provided, weakening the opponent's presumptions.
   3. Analysis of the "No": Practitioners must investigate whether valid therapeutic alternatives existed, as their absence makes the alleged refusal less plausible.
   4. Damage assessment: A claim for breach of self-determination requires a rigorous demonstration of the subjective suffering resulting from being denied the freedom of choice.

References: Articoli 2, 13, 32 Costituzione ItalianaLegge 22 dicembre 2017, n. 219Articoli 1218, 1223, 2697 Codice Civile

Editorial oversight: Avv. Federico Papa·ICAMUpdated 26 June 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