Medical Malpractice: the Italian Supreme Court clarifies the role of incomplete medical records and hospital-acquired infections

In Order No. 24912/2026, the Third Civil Division reaffirmed that incomplete medical records may play a significant role in establishing the causal link between the conduct of healthcare professionals and the harm suffered by the patient.
The case concerned an oncology patient who had been fitted with a central venous catheter and subsequently developed a severe Staphylococcus aureus infection. However, the available medical documentation did not make it possible to adequately reconstruct the reasons that had made the placement of the catheter necessary.

According to the Supreme Court, where gaps in medical documentation make it difficult or impossible to establish circumstances relevant to determining liability, the resulting uncertainty cannot automatically operate to the detriment of the patient. In accordance with the principle that the burden of proof should fall on the party with easier access to the relevant evidence, incomplete medical records may support a presumption in favour of the injured party, provided that conduct on the part of the healthcare professionals has been identified which was, in principle, capable of causing the harm.

In the related Order No. 24916/2026, the Supreme Court addressed hospital-acquired infections, clarifying the allocation of the burden of proof between the patient and the healthcare facility.

The patient – or, in the event of death, the patient’s family members – must establish the causal link between the healthcare treatment and either the deterioration of the patient’s health or the onset of a new medical condition. However, once it has been established, including by means of presumptive evidence, that the infection was contracted in a hospital setting, it is for the healthcare facility to prove that it actually implemented all necessary measures to prevent the infection.

A general reference to the existence of internal protocols is therefore insufficient. The healthcare facility must provide evidence that the relevant preventive measures were effectively implemented, including disinfection and sterilisation procedures and microbiological surveillance, with specific reference to the period and hospital department concerned. At the same time, the Supreme Court emphasised that liability for hospital-acquired infections is not strict liability: the mere occurrence of an infection does not automatically give rise to a right to compensation.
Taken together, the two decisions confirm the central role of medical documentation in healthcare liability disputes. Incomplete medical records may have specific evidentiary significance when establishing causation, while, in cases involving hospital-acquired infections, healthcare facilities are required to demonstrate not merely the existence of preventive measures, but their effective implementation in practice.

References: Italian Supreme Court, Third Civil Division, Order No. 24912 of 1 September 2026; Italian Supreme Court, Third Civil Division, Order No. 24916 of 1 September 2026.