Medical malpractice: the Court of Rome rules on nosocomial infections
The Court of Rome, in Ruling No. 3386 of March 5, 2026, addressed medical malpractice regarding nosocomial infections contracted during hospitalization. The decision clarifies that while the patient must prove the causal link between the hospital stay and the infection, the burden shifts to the healthcare facility to prove the diligent adoption of all prevention and sanitization protocols. The Court ruled that generic defenses based on the inevitability of infectious risk are insufficient; hospitals must provide rigorous documentary evidence concerning the sterility of environments and medical devices to avoid liability. This approach reinforces the duty of risk management and requires analytical documentation of hospital hygiene procedures to prevent successful compensation claims.
In its recent Ruling No. 3386 of March 5, 2026, the Court of Rome revisited the sensitive issue of medical malpractice regarding nosocomial infections (hospital-acquired infections). This decision provides essential clarifications on the allocation of the burden of proof, defining the specific criteria under which a healthcare facility may be exempted from liability for pathologies contracted during a patient's stay.
Case background and legal framework
The dispute arose from a compensation claim filed by a patient who, following a correctly performed surgical procedure, developed a severe bacterial infection during post-operative recovery. The claimant sued the hospital, alleging a lack of adequate prophylaxis and environmental hygiene measures.
The governing legal framework remains the Gelli-Bianco Law (L. 24/2017), which classifies the liability of healthcare facilities as contractual in nature. This classification has significant procedural implications, particularly concerning the burden of proof in cases of infectious complications, where the line between an "unforeseeable event" and "organizational failure" is often blurred.
The legal issue: the burden of proof
The core of the decision lies in the correct application of the principle of proximity of proof. According to the consolidated orientation confirmed by the Court, a patient fulfills their evidentiary burden by proving:
- The onset of the infection during the period of hospitalization (or within a timeframe compatible with the known incubation period);
- The causal link between the hospital stay and the detected pathology.
Once this evidence is provided, the burden shifts to the healthcare facility. To avoid liability, the hospital must demonstrate that it adopted all preventive measures prescribed by clinical guidelines and best practices. This is not a simple task, as it requires proving a "negative fact": namely, that the event was unavoidable despite the exercise of maximum organizational diligence.
The Court’s decision and legal principle
With Ruling No. 3386/2026, the Court of Rome established that a facility cannot merely produce generic certifications regarding premises cleanliness. To rebut the presumption of fault, the hospital must document with precision the actual implementation of sterilization protocols, the proper maintenance of ventilation systems, and the strict adherence to hand-washing procedures by staff.
The Court emphasized that a nosocomial infection is not an "inherent risk" that must always be accepted. Rather, it is an event that the facility must manage through rigorous risk management. The failure to produce sanitization logs or technical data sheets for the medical devices used precludes the facility from invoking an "unknown cause" or the inevitability of the damage.
Operational implications for facilities and patients
This ruling strengthens patient protection while outlining a clear roadmap for healthcare management. Facilities must invest in the total traceability of hygiene processes. The decision highlights three critical points:
- Clinical documentation must be comprehensive, covering not only medical treatment but also environmental and logistical aspects.
- The absence of documentary evidence regarding compliance with protocols is procedurally equivalent to proof of breach of contract.
- Liability for infection can only be excluded if the facility demonstrates that the bacterial strain was resistant to every reasonable and standardized prophylactic measure.
