October 4th, 2010

Continental European Legislative and Judicial Trends: Latest Developments in the Field of Medical Malpractice in Italy

Posted at 1:00 AM ET

2010_legislative_thumb-2David Lewin, Managing Director

In the last decade, the scope of the liability as well as the amount of compensation for medical malpractice have been continuously increasing owing to several innovative rulings of the Supreme Court (Corte di Cassazione). Now, many insurance entities, once very active in this field, are beginning to lose interest in this business.

Having said that, we must welcome the attempts that the jurisprudence of the same Supreme Court recently made in order to mitigate the extreme consequences that a too strict approach to some of the most important and contradictory issues of medical malpractice could have brought.

We will address the issues of:
i) allocation of the burden of proof between the damaged party and the defendant;
ii) nature of liability for lack of informed consent, the kind of damages that can be awarded to the patient for such reason and under which conditions.

The Allocation of the Burden of Proof
Traditionally, in the matter of medical malpractice, the burden of proof rested quite heavily on the part of the plaintiff, since he had to give evidence that:
i) he received medical treatment;
ii) his health condition worsened after the treatment;
iii) the doctor failed in executing the treatment by giving specific reason
for such allegation;
iv) the damage suffered was causally linked to such a medical failure.

Point iii) and iv) were deemed necessary because a common theory was that the obligations of hospitals and doctors were to use their best efforts to cure the patient according to best practices and medical guidelines, but without a guarantee for the result of their activity.

That is why, in order to sustain the allegation of malpractice, it was not sufficient to prove the requirements described in points i) and ii). It was necessary to explain and demonstrate what the doctor should have done according to the best standard and medical guidelines.

Recently, jurisprudence in the field of medical malpractice as well as in the area of contractual liability has almost abandoned the theory of the use of the best effort, stating that, when a contract is entered into between the parties, the debtor must perform his obligations with the due diligence required. Therefore, there is a presumption that such performance will result in a satisfactory outcome for the creditor. Then, the issue of having used the best effort or following the best practices becomes a matter to be demonstrated in practice by the debtor.

In its important case (see Cass.S.U. n.13533/2001) the Supreme Court - in plenary session - affirmed, quite blatantly, that the burden of the proof for the plaintiff was only to give evidence of the contract and damages possibly arising out of the performance of such contract. The debtor, however, needs to prove that he performed the contract with duty and care, meaning that he was not at fault or that his failure did not cause the damage.

In other words, the Court stated that it was no longer the duty of the plaintiff to give specific evidence on the element described in point iii).

This would make the defendants’ task more difficult. It would also likely cause an increase in litigation between hospitals and patients.

More recently, however, the same Supreme Court in plenary session (see Cass.S.U. n.577/2008) slightly revised its theory by affirming that a general claim of bad performance of the contract was not sufficient to hold the hospital/doctors liable. The plaintiff, in fact, had the duty to make a specific allegation regarding the failure that was deemed to be the possible cause of the damage.

This clarification has certainly contributed to bringing more balance to the position of the parties and it could be understood in the sense that the Supreme Court had reinstated the duty to give evidence of the element in point iii).

However, this is not quite the case, since, even if it is true that the plaintiff has to identify the possible failure that could have caused the damage, the burden of proof for a specific allegation is not as rigorous as it was previously.

Lack of Informed Consent and Recoverable Damages
According to Italian law and practice, the liability of hospitals and doctors regarding lack of informed consent is based on a doctor’s failure to adequately inform the patient about the risks implied in the execution of a medical procedure before its commencement.

It is important to outline that this special type of medical malpractice occurs only in those cases where no other fault or malpractice can be attributed to the doctor. This liability occurs even if the doctor cannot be found liable for his medical acts or treatments, as they have been done in compliance with the guidelines and best practices applicable in the given circumstances.

In summary, liability deriving from lack of informed consent makes the hospitals and doctors pay for the limits and drawbacks still present in medical science. The judges are perfectly aware of this risk and therefore on several occasions have tried to specify the exact nature of this responsibility and what kind of damages are deemed to be recoverable by the patients.

Jurisprudence has clarified that liability for lack of informed consent does not constitute a direct violation of the patient’s health by a medical act or omission of the doctor, since this act or omission is assumed to have been done with the required professional skill and care, but rather the violation of the freedom of the patient to make an informed choice as to whether to undergo the medical treatment or not.

This specification bears very important consequences in the trial practice.

Indeed, the Supreme Court has stated that when a plaintiff intends to recover damages based on the theory of liability for lack of information, he must make a specific demand for it. A general allegation of medical malpractice is not sufficient for that purpose, since liability for faults and errors in performing medical treatments is substantially different from the liability derived from failure to inform the patient before acquiring his/her consent for that treatment.

The said specification regarding the nature of the liability has inspired other fundamental changes in jurisprudence in relation to the type of compensation which can be awarded to a patient who has not been correctly informed and has suffered personal injuries as an unfortunate outcome of the medical treatment. Since the theory of liability for lack of informed consent was created, the liable party was responsible for the entire corporal and moral damages suffered as a consequence of the medical treatment, as if such damages had been actually caused by the lack of information provided to the patient, rather than by the inevitable unfortunate outcome of a correctly executed medical act.

This approach was perceived as not completely satisfactory from a legal standpoint. Moreover, this has brought good arguments to those who inferred that, through the theory of the liability for lack of informed consent, the Courts were making the hospitals pay for the gaps still existing in the medical science.

An attempt to correct this issue was made by a jurisprudence trying to clarify that the due compensation in cases of lack of information in the medical practice was aimed to compensate the non-patrimonial damage resulting from the violation of the freedom of the patient to choose the medical treatment he/she is advised to take. Therefore, the amount of the awardable compensation was to be calculated on the basis of a fair and discretional evaluation by the judge, rather than on the exact degree of disability suffered by the damaged person. Based on this theory, a judge awarded damage compensation also in a case where the patient, who had not been correctly informed - and therefore was not put in the position to express his free and informed will - did not suffer body injuries as a consequence of the medical act.

At the beginning of this year, the issue has been discussed and solved in a more satisfactory way by the Supreme Court, which, in decision n.2847/2010, affirmed, in clear terms, that, in case of lack of informed consent, there must be some causal relationship between the lack of informed consent and the ultimate injury suffered by the patient. The damaged party must prove that had he/she been informed properly, he/she would not have consented to the medical treatment and that the medical outcome would have been different. In addition - and this is crucial - the Supreme Court stated that the burden of proving the existence of the said causal relationship between the lack of informed consent and the body injuries, with all the specification described above, lies on the patient.

These findings are to be welcomed as they contribute to bringing more balance in the allocation of the risk of medical malpractice in cases where the unfortunate outcome of a legitimate and often skilled performance of a medical act is still not under the control of the medical profession.

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