Civil Cassation: the burden of proof in medical complications

1. The facts

   The case originates from a claim for damages filed following a surgical procedure that, although technically performed without errors, caused a rare complication resulting in severe disability. The lower courts dismissed the claim, holding that the adverse event fell within the calculated risk of that specific medical procedure. The matter reached the Court of Cassation, where the appellants challenged the misapplication of the rules governing the burden of proof, arguing that the healthcare facility had failed to provide the necessary exculpatory evidence. The core issue lies in the boundary between medical error and unpredictable complications, given the patient's contention that the facility failed to demonstrate the impossibility of preventing the damage despite exercising due professional diligence.

2. The laws in play

   The medical liability system is grounded in Art. 1218 of the Civil Code, which governs contractual liability: the healthcare facility is liable for damages unless it proves that the non-performance or improper performance was due to a cause not attributable to it. Art. 2697 of the Civil Code is equally fundamental, as it regulates the burden of proof between claimant and defendant. The Gelli-Bianco Law (Law 24/2017) reaffirmed the contractual nature of the facility's liability, applying the ten-year statute of limitations. Lastly, Art. 1223 of the Civil Code governs legal causation, establishing that damages must cover both the actual loss suffered and the lost profits that are a direct and immediate consequence of the breach.

3. Jurisprudence

   The Supreme Court has long structured medical liability around the double causal cycle framework. First, the patient must prove, under the «more likely than not» standard, the causal link between the medical treatment and the deterioration of their health. Once this burden is satisfied, the onus shifts to the healthcare facility to provide exculpatory evidence, demonstrating that the event was caused by an external, unforeseeable, and unavoidable factor. Case law highlights that the clinical notion of a complication holds no independent legal relevance: if an event is foreseeable, the healthcare provider must take all appropriate measures to prevent it, failing which the facility remains liable regardless of how the event is classified in medical literature.

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8. Lessons for professionals

   1. It is essential to structure the evidentiary phase around material causation, verifying that the link between medical treatment and damage is fully substantiated by medico-legal documentation before commencing litigation.
   2. Analysis of medical records must extend beyond identifying execution errors to checking for missing evidence regarding compliance with safety protocols and clinical guidelines.
   3. Expert witness reports should focus on the foreseeability of the event, countering allegations of an «unavoidable complication» through updated scientific literature.
   4. Legal practitioners must remember that the burden of proof is the key determinant of outcome: identifying who must prove what dictates defense strategy from the initial pleadings.

References: Art. 1218 c.c.Art. 2697 c.c.Art. 1223 c.c.Legge 24/2017

Editorial oversight: Avv. Federico Papa·ICAMUpdated 4 November 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