Nosocomial infections: standards for assessing healthcare facility liability clarified ( Italian Supreme Court of Cassation Civ. 6386, March 3, 2023)

The Italian Supreme Court, in ruling No. 6386 of March 3, 2023, provided clarification on the criteria for determining the liability of healthcare facilities in cases of nosocomial infections.

What is a nosocomial infection and why is the Cassation ruling so relevant?

A nosocomial infection is an infection contracted by a patient during his or her stay in a hospital or other healthcare facility. The Italian Supreme Court ruling No. 6386 of March 3, 2023, is of significant interest because it clarifies the standards for determining the liability of health care facilities in the case of such infections, establishing that proof of the causal link between the behavior of health care providers and the harmful event must be provided in probabilistic terms, and not with absolute certainty.

This approach allows for a balanced assessment of the liability of healthcare facilities and protects the families of victims, avoiding the automatic awarding of damages to every case of fatal infection without considering the specific circumstances and the presence of an actual causal link.

The Italian Supreme Court’s ruling helps to more clearly define the criteria for assigning liability to healthcare facilities in cases of nosocomial infections, facilitating the analysis and evaluation of individual cases by professionals, such as lawyers and medical examiners, and providing greater protection for both patients and the healthcare facilities involved.

What does it mean that the liability of the health care facility should be provided in probabilistic terms?

Supreme Court Judgment No. 6386 of March 3, 2023, states that, in cases of nosocomial infection, proof of the causal link between the behavior of the sanitarians and the harmful event must be provided in probabilistic terms. This means that a plaintiff for damages must prove that the negligent behavior of the sanitarians caused the injurious event with a higher degree of probability than other possible causes, and not with absolute certainty. This criterion is based on logical probability and takes into account the confirmatory evidence available in the specific case.

To determine the liability of the health care facility, the Court identified three criteria, temporal, topographical, and clinical:

1. The temporal criterion refers to the number of days elapsed after discharge from the hospital;
2. the topographical criterion refers to the occurrence of infection at the surgical site affected by the surgery;
3. finally, the clinical criterion applies when, given the specificity of the infection, it is possible to ascertain what preventive measures were necessary.

In summary, the ruling states that in order to ascribe liability to the health care facility in cases of nosocomial infection, it is necessary to prove the causal link between the negligent behavior of the health care providers and the harmful event with a degree of logical probability, based on the temporal, topographical, and clinical criteria. This approach allows liability to be assessed in a balanced and considered manner, avoiding unfair analogies between contracting a nosocomial infection with fatal outcomes and awarding damages.

What evidence must be gathered to prove the liability of the health care facility?

To prove that a health care facility failed to take sufficient preventive measures in a case of nosocomial infection, information and documents must be gathered that address the temporal, topographical, and clinical criteria established by the Supreme Court.

To prove when the infection arose and what its time course was, it is important to document:

• the number of days elapsed after discharge from the hospital;
• medical records;
• medical prescriptions;
• medical reports;

Regarding the topographical criterion, it is necessary to prove the occurrence of the infection at the surgical site affected by the surgery.

In this case, for example, it is essential to collect:

• the diagnostic images;
• operative reports and medical reports attesting to the patient’s condition and the location of the infection.

Finally, for the clinical criterion, it is necessary to ascertain what preventive measures were necessary based on the specificity of the infection. It is important to collect:

• guidelines, protocols and procedures adopted by the health facility,
• comparing them with the recommendations of health authorities and good practices in the prevention of nosocomial infections.

This type of documentary and informational collection is entrusted to a qualified law firm with the support of a medical examiner.

Injured person's relatives can also sue for "malpractice". What does that mean?

A lawyer experienced in health law (so-called healthcare malpractice) can certainly provide crucial support in the presentation of a properly substantiated and evidence-supported legal claim. With expertise and knowledge of the regulations and case law, the lawyer will be able to assess the specific case and identify the elements of extra-contractual liability of the health care facility, helping the next of kin of the patient-creditor to assert the injuries suffered.

The proposed iure proprio action of extracontractual liability allows the next-of-kin-actors to sue for compensation for the injuries suffered, provided that they can provide evidence of all the constituent elements of the facility’s extracontractual liability, namely the negligent act, the injury that resulted from this act to the patient-defendant, and the causal link between the negligent act and the injury.

An experienced lawyer will then be able to analyze the case in light of the temporal, topographical, and clinical criteria established by the Supreme Court in its ruling No. 6386 of March 3, 2023, and guide the joint-actors in gathering the necessary evidence to prove the failure of the health care facility to comply with preventive measures and the causal link between that failure and the harmful event.