Vaccine-related injuries from the Sabin polio vaccine and the liability of the Ministry of Health: the ruling of the Court of Cassation in order no. 30526 of 2025

The liability of the State, and specifically of the Ministry of Health, for damages resulting from the administration of vaccines is an extremely sensitive legal issue of constant relevance. With order no. 30526 of November 20, 2025, the Third Civil Section of the Court of Cassation has once again ruled on the necessary prerequisites to establish the fault of the public administration in cases of serious adverse reactions following the administration of the "Sabin" type polio vaccine, which occurred in the late 1960s.

The specific case and the decision of the lower courts

The case stems from a serious pathology contracted by a minor (represented by T. with the assistance of lawyer S. P.) following the inoculation of the fourth dose of the Sabin polio vaccine, which took place in February 1967. The lower courts, and in particular the Court of Appeal of Rome in its judgment of May 10, 2024, had excluded the compensatory liability of the Ministry of Health. The main reason was that, at the time of administration, the specific contraindications related to the child's health conditions were not known to the scientific community. Such contraindications were, in fact, only formalized subsequently, with the Ministerial Decree of May 25, 1967.

The parameter for assessing fault and the state of scientific knowledge

The Supreme Court confirmed the orientation of the second-instance judges, dismissing the appeal. The core of the decision lies in the definition of the concept of "fault" pursuant to Article 2043 of the Italian Civil Code. It is not possible to attribute strict liability or generic fault to the Ministry based on an abstract and indiscriminate danger of the vaccine. On the contrary, the conduct of the administration must be evaluated based on the scientific knowledge available at the exact moment of administration.

Here are the key points highlighted by the Court of Cassation for assessing liability:

• Timeliness of knowledge: The State cannot be held liable for failing to foresee a risk that the medical science of the time had not yet identified or codified.
• Individualized assessment: Fault must be calibrated to the specific health conditions of the patient at the time of inoculation, as ascertainable by medical personnel.
• Unreasonableness of expecting different conduct: If the contraindication was not scientifically known before May 1967, it cannot be expected that medical personnel would have avoided the administration in February of the same year.

The legal principle (massima) of the Court of Cassation in order no. 30526/2025

To fully understand the scope of this ruling, it is useful to read the official legal principle established by the Court:

Regarding the liability of the Ministry of Health for damages resulting from the administration of the "Sabin" type polio vaccine, the parameter for assessing fault cannot be traced back to a generic and indiscriminate danger of the vaccine to the patient's health, as it must be calibrated to the specific conditions of the latter, as ascertained by medical personnel at the time of the administration itself.

This principle clearly defines the perimeter of civil liability ex art. 2043 of the Civil Code as applied to public health. The Court of Cassation emphasizes that the intrinsic danger of a drug or vaccine is not sufficient in itself to establish compensatory fault on the part of the Ministry, provided that the State acted in accordance with the protocols and knowledge of the time. The causal link and fault must therefore be analyzed through the lens of the concrete scientific foreseeability of the damage at the relevant historical moment.

Conclusions

In conclusion, order no. 30526 of 2025 reaffirms a principle of legal civilization and scientific rationality. Even in the face of the human tragedy linked to serious pathologies contracted due to a vaccination, the compensatory liability of the State cannot be transformed into a form of absolute and retroactive strict liability. The protection of those damaged by irreversible complications finds specific indemnity channels provided by law, but the path of compensation for damages requires proof of fault which, in this case, was correctly excluded due to the scientific unpredictability of the risk in February 1967.