More invasive surgery: the Court of Cassation reinforces informed consent
The patient does not bear the burden of proving that, had he been informed, he would not have consented to an operation other than the planned one
by Pietro Verna
In the case of more invasive surgery than planned, the patient does not bear the burden of proving that, had he been informed, he would not have consented. A different solution would be contrary to the right to self-determination provided for in Article 1 of Law No. 219 of 22 December 2017 (Norme in materia di consenso informato e di disposizioni anticipate di trattamento No. 219 of 2017). This was established by the Court of Cassation- Third Civil Section in its Order No. 11608 of 28 April 2026.
The Supreme Court's pronouncement
In the course of an operation for which a patient had given her consent (prosthetisation of the aorta), the doctors had performed a more complex operation (replacement of the descending aorta and plastic enlargement of the distal aorta) following which the patient had died. The Court of First Instance and the Court of Appeal of Bologna had rejected the claim for damages filed by the patient's husband, holding that he had to prove that his wife would have refused consent had she been informed that a different operation than the one agreed upon would have been performed. This argument was not well-founded.
The Supreme Court ascertained the intelligibility of the information provided to the patient ("it is [impossible] to identify what, in concrete terms, the information to be considered sufficient for the purpose of forming and expressing informed consent consisted of") and the consequent violation of the right to self-determination. Hence the Supreme Court's decision: "...in such a situation the burden of proving that, had he been informed of the more complex intervention that the doctors were planning to carry out, he would not have consented, does not rest on the patient. On the contrary, faced with the patient's allegation that her consent would have been limited to what was planned and no further, the burden was on the [hospital] structure to prove that she would have given consent to the second and more invasive intervention'.
A new orientation
A decision that departs from the orientation according to which:
- the harmful consequences arising from the infringement of the right to self-determination must be duly alleged by the patient, "on whom lies the burden of proving the positive fact of the refusal that he would have opposed to the doctor, taking into account that the prerequisite of the claim for compensation is his subjective choice" (Court of Cassation, Sec. III, judgment of 11 November 2019, no. 28985);
