THE MEDICAL LIABILITY IN TIME OF THE CORONAVIRUS, BETWEEN HEROIC HONORS AND PROFESSIONAL BURDENS
The Covid19 pandemic emergency is putting a strain on healthcare systems around the world.
Some of the countries affected by the contagion, including Italy, are already recording many thousands of victims, in a situation of general difficulty caused by several factors, among which are certainly the still poor scientific knowledge of the virus, the insufficient diffusion of tests for diagnosis, the lack of specific medical equipment, personal protective equipment and intensive care posts in hospitals.
In short, a situation that clashes with a principle enshrined in the Italian Constitution, Article 32 of which imposes an uncompromising protection of health "as a fundamental right of the individual and the interest of the community".
Law 23 December 1978 no. 883, establishing the National Health Service, implements this constitutional principle, establishing that citizens must be guaranteed equal access to treatment in relation to equal health needs, both physical and mental: health protection should therefore become the primary criterion of choice and planning, including economic, for all public institutions, in order to ensure the universality of the service and facilitate equal use.
It is no coincidence that the emergency regulations issued by the Government in recent weeks, to deal with and contain the expansion of coronavirus contagion, have placed public health at the top of the scale of values and interests to protect, sacrificing others of equal constitutional rank, such as freedom of movement and economic initiative.
In this context, there has been no lack of doubt and controversy about the responsibilities associated with the spread of the virus and the many resulting deaths. Especially when there have been hypotheses of non-diagnosis or late diagnosis with fatal outcomes.
The chronicle reports numerous cases of investigations, opened in this sense at various judicial offices, including some coarse fake news on alleged arrests of doctors, fortunately never happened. Rather well known personalities of the Italian legal profession have used contemptuous words towards medical doctors, while others - perhaps of lesser fame - have spread illusory advertising about the possibility of claims damages, against which many Forensic Orders are proceeding disciplinarily, being considered careless.
All this has led political forces to consider the advisability of introducing a "criminal shield" to protect doctors and health care facilities, in the form of an amendment in the conversion into law of the so-called "Decreto Cura Italia" (Decree Law 17 March 17 2020 no. 18). The hypothesis that circulates, at the date of drafting of this article, is about the introduction of an article 13/bis, entitled "Limitations to civil, criminal and administrative liability of health care facilities and health care professionals", which would exclude, for the period of the emergency, the possibility of configuring any kind of culpable liability on the part of health care providers, thus limiting it only to wilful misconducts.
But what is, in the Italian legal system, the legal basis of health responsibility?
In general terms - and attempting a technically correct classification - it can be affirmed that there is a health care liability when there is a causal link between an injury to the patient's psychophysical health and the conduct of the health care worker, whether or not concomitant with any inefficiency and/or shortcomings of the structure in which the activity of the same worker has been carried out.
The concept of responsibility refers to the obligation to answer for the consequences deriving from a conduct, whether commission act or omission act, which is in violation of a given rule to be followed in the performance of a certain activity. To this end, Article 43 of the Italian Criminal Code, focusing attention on the event that arises as a consequence of the violation, clarifies that if the same "is by the agent foreseen and intended as a consequence of his action or omission" it will be wilful misconduct, while if, even if foreseen, such event "is not intended by the agent and occurs due to negligence or imprudence or inexperience, or for failure to comply with laws, regulations, orders or disciplines", it will be negligence.
Restricting itself here to the hypothesis of culpable liability, which in the matter under examination statistically represents the one of greatest verification, the negligence will be of a generic type whenever there will be the three different cases provided for by the above mentioned Article 43 of the Italian Criminal Code, which traditionally also correspond to a gradation of negligence conceived on three levels of increasing severity:
1) negligence, in the sense of superficiality, carelessness or inattention, which is identified as "slight negligence": in general, it occurs when the agent assumes a demeanour that falls short of the ordinary diligence "of the good father of the family" (in the health field, an example is about the doctor who prescribes one medicine instead of another, or does not notice the failure to remove foreign bodies during surgery);
2) imprudence, in the sense of recklessness or temerity, which, depending on the case, may constitute a hypothesis of "average negligence" or "serious negligence" (in the health field, for example, it is the case of the doctor who decides to perform a certain practice even though he is aware of specific risks for the patient);
3) incompetence, in the sense of lack of professional preparation due to incapacity, insufficient technical knowledge or specific inexperience: in this case the fault will certainly be "serious" or, in cases with more harmful consequences, "very serious" (which is characterized, also in the health sector, by an absolute lack of foresight, common experience, and a manifest lack of interest in the consequences of the actions carried out, at the limits of wilful misconduct).
There will be a more specific negligence, in the health sector, when the event detrimental to the patient will be a direct consequence of the violation of rules that the doctor could not ignore and was expressly required to observe, because contained in laws or provisions of a public or hierarchical authority, governing specific activities or the proper conduct of health procedures to be applied in the specific case.
As mentioned above, liability also presupposes the existence of a causal link between the error committed by the doctor and the damage suffered by the patient: in other words, the latter must be a direct consequence of the former.
From this point of view, the investigation into the civil law nature of medical liability, which has been debated at length in doctrine and jurisprudence and which can historically be traced back to three different hypotheses, acquires extraordinary importance:
- according to a first thesis, it would be a purely contractual liability, under Article 1218 of the Italian Civil Code, according to which "the debtor" - to be identified in this case with the health care professional - "who does not perform exactly the service due is required to pay compensation for damages, if he does not prove that the non-performance or delay was caused by the impossibility of the service resulting from a cause not attributable to him";
- according to another argument, the liability in question would instead be non-contractual in nature, reflected in the general principle of neminem laedere set out in Article 2043 of the Italian Civil Code, according to which “any intentional or negligent act, causing unjust damage to others, obliges the person who committed the act to pay compensation for the damage”;
- according to a last thesis, which deals with the case of a physician employed by a healthcare facility, the liability would substantially derive from the combination of the two previous types: in fact, considering that the doctor does not have any contract directly stipulated with the patient – but he has a contract with the healthcare facility which acts as employer, which in turn establishes the contractual relationship with the patient - and that our system does not contemplate responsibilities other than the contractual and non-contractual one, a sort of unnamed tertium genus was proposed, arising precisely from the accumulation of the two responsibilities, one properly under the structure and the other under the medical profession, with consequent possible uncertainties regarding the imputation of the same.
In view of this multiplicity of views, the subsequent jurisprudential introduction of the principle of the so-called "social contact" has deeply affected the legal qualification of the doctor's liability, rooting it in the contractual framework also for the hypothesis of the physician employed in a health facility: the regulatory reference was found in Article 1173 of the Italian Civil Code, according to which "obligations derive from contract, unlawful act and any other act or fact suitable to produce them in accordance with the legal system".
Medical liability from social contact has thus been identified as a source of obligation, with the consequent application of the contractual liability pursuant to the above mentioned Article 1218 of the Italian Civil Code: in fact, jurisprudence was mainly oriented in favour of the contractual nature of such liability, as it considered the position of the doctor, even if employed by the healthcare facility, equal to that of any other legal entity exercising a professional activity.
In this wake, the Decree Law 13 September 2012 no. 158, the so-called "Decreto Balduzzi" (converted with amendments into Law 8 November 2012 no. 189), Article 3, paragraph 1, expressly refers to the provision set forth in Article 2236 of the Italian Civil Code. on the liability of the "service provider" (according to which, "if the service involves the solution of technical problems of special difficulty", such person "shall not be liable for damages, except in case of wilful misconduct or gross negligence"), which undoubtedly represents a hypothesis of contractual liability, and then provide that in cases where this rule does not apply, since it is necessary to ascertain slight negligence, it is necessary to take into account "in particular the observance, in the specific case, of the guidelines and good practices accredited by the national and international scientific community", in view of the provisions of art. 1176 of the Italian Civil Code (which prescribes the so-called "diligence of the good father of the family" in the fulfilment of contractual obligations).
A subsequent legislative intervention has, however, completely overturned the thesis of the contractual nature of health care liability, affirming on the contrary a non-contractual liability of the doctor, unless he acts in the fulfilment of an obligation assumed directly with the patient.
Law 8 March 2017 no. 24, the so-called "Law Gelli-Bianco", which currently regulates this matter, provides in fact in art. 7, paragraph 3 that the health care professional "is liable for his actions pursuant to Article 2043 of the Civil Code, unless he has acted in the performance of a contractual obligation assumed with the patient". The same rule also provides that, when ascertaining civil liability and quantifying any compensation, the judge must assess the level of adherence of the healthcare professional to the recommendations provided for by specific guidelines and good clinical-assistance practices.
Article 6 of the same Law introduced Article 590/sexies of the Italian Criminal Code which, in affirming the applicability of the rules on manslaughter (Article 589 of the Italian Criminal Code) and on personal injury (Article 590 of the Italian Criminal Code), also for facts committed in the exercise of the health care profession, excludes, however, the punishability "when the recommendations provided for by the guidelines are respected as defined and published in accordance with the law or, in the absence of these, the good clinical-assistance practices, provided that the recommendations provided for by the aforesaid guidelines are adequate to the specificity of the concrete case".
In other words, in the current regulatory framework, the health care worker already enjoys a real "criminal shield" if the doctor complies with the guidelines and good practices accredited by the scientific community. Moreover, such compliant conduct also mitigates and potentially excludes the civil liability, in the case of negative outcomes of the activity performed, not to mention that, since the liability is now expressly qualified as "Aquiliana" under Article 2043 of the Italian Civil Code, the doctor will benefit from the related advantages, from the five-year prescription of the action, to the burden of proof on the injured patient.
What happens when there are no clear guidelines and good practices to follow, as in the case of coronavirus infection?
Clearly different and extraordinary is the hypothesis in which the health care worker does not have safe references with which to standardise the conduct.
This is the case, for example, of pulmonary infection with the new coronavirus: a disease of which the international scientific community is not yet fully aware, which appeared for the first time a few months ago and with an objectively unpredictable infectious capacity, which has caught practically all healthcare systems in the world unprepared.
A pandemic, as declared by the World Health Organization on 30 January 2020, which determined in our system the adoption by the Italian Council of Ministers on 31 January 2020, of a formal declaration of national state of emergency for the duration of six months.
The scope of the obligation to which the health care professional is bound, in the performance of his activity, is extremely wide and includes all types of services (diagnostic, preventive, hospital, therapeutic, surgical, aesthetic, care, etc.), which may in practice be carried out by doctors and personnel with different qualifications, such as nurses, health care assistants, technicians, etc. There are, therefore, various nuances and as many different specific approaches of jurisprudence to the related responsibilities.
Among these possible nuances, the hypothesis of omitted or late diagnosis of Covid19 infection, with the consequent absence of treatment, or hospital contagion, appears to be of clear relevance and topicality in relation to the events mentioned at the beginning of this article.
The first hypothesis evidently concerns the responsibility of the medical staff, the second concerns above all, but not exclusively, the healthcare structure: the nosocomial infection can in fact constitute a "complication" of the therapy, with consequent responsibility mainly on the part of the therapist, i.e. a consequence of the healthiness of the structure, due to organizational-managerial deficiencies, with consequent chargeability to the apical subjects of the same.
This article wants to focus on the responsibility of the health care worker and, therefore, will be limited to the examination of the first of the two cases that emerged from the recent chronicle: the omitted or late diagnosis.
Although it should be pointed out that the case law available to date has not yet been able to address this specific case related to coronavirus infection, the dominant orientation would affirm the responsibility of healthcare workers even in the event of failure to prevent the disease.
The Court of Cassation, in fact, with judgment no. 8461 delivered by the Third Civil Section on 27 March 2019, had already held that the causal link between the doctor's omission behaviour and the injury suffered by the patient could be established if, by means of a necessarily probabilistic criterion, it was held that the doctor's work, if correctly and promptly performed, would have had serious and appreciable possibilities of avoiding the damage that had occurred: in particular, the rule of the Civil Code must be applied the rule of the "preponderance of the evidence" (or of the "more probable than not") to the causal link between the doctor's conduct and all the harmful consequences that resulted from it. It has been specified, moreover that "anticipating the death of a person already destined to die because he or she is afflicted by a pathology still constitutes conduct linked by a causal link with respect to the event of death and obliges the person who held him or her to pay compensation for the damage".
Therefore, thinking inversely, this authoritative orientation allows us to state that, when the criterion of "more probable than not" applied to the concrete case leads to the "not", liability must be excluded.
Well, is only right to ask if, especially in the light of the extreme novelty and unpredictable speed of spread of Covid19 infection, it is really possible, even in this specific case, to apply the rule of the preponderance of evidence (or of the "more probable that not") to the causal link between the omitted diagnosis by the doctor and the possible consequences for the patient.
This, of course, taking into account the succession of events, even dramatic ones, that have occurred in recent weeks and also analysing the conditions in which the health care personnel are operating, in a "state of national emergency" declared by the Government: the methods of emergency intervention on a completely unknown matter, the absence of specific drugs and validated treatment protocols, the multiple trials in progress, the very difficult conditions in which they have to work every day, with an overcrowding of hospitals and surgeries, lack of specific machinery, essential medical equipment, the same swabs and reagents for the administration of virological tests, often even the personal protective equipment necessary to protect the operators themselves from infection.
In the writer's opinion, in a situation of this magnitude, no responsibility should be attributed to the health care professional. There are at least two reasons for this.
First of all, as mentioned above, the recent onset of the disease does not allow the doctor's work to be parameterized to precise guidelines - non-existent or, even if existing, not validated by the international scientific community, if not limited to certain hygienic practices - so that it lacks a term of comparison for the exact identification of a fault. In other words, to date, it is not possible to link to an objective parameter the qualification of the possible fault of the doctor, both in case of omitted diagnosis and in case of error in the therapy. This should reasonably induce the interpreter to limit the limitation of liability to only the hypothesis of wilful misconduct and, at most, of very serious negligence determined by an inexcusable error.
Secondly, as already mentioned, when assessing the liability of the individual, the general emergency context in which all healthcare professionals involved in the treatment of Covid-19 patients were forced to operate should be taken into account. The exceptional virulence of the disease has, in fact, led to a very high number of infected people, many of whom had to be admitted to intensive care. This led, within a short period, to the complete saturation of the beds in the hospitals and, therefore, the right to health of each patient had to be reconciled with the limited number of places in the wards. In addition, from a point of view limited to the diagnosis phase, a large number of doctors reported a shortage of swabs or reagents for testing for Covid-19 positivity. The apparent "guideline" followed, according to what has been learned, was therefore to limit the execution of the so-called swab only to patients who did not present mild symptoms of the disease. This was also to keep silent about the fact that all the health care staff operated under stress that was certainly out of the ordinary, resulting also from being primarily exposed to contagion.
In short, all the circumstances considered above, in one with the lack of well-established and validated guidelines and practices of the entire scientific community should be likely to break the causal link between the conduct of the health care professional and the death of the patient.
In any case, given the clear emergency nature of the situation created, also recognized by a formal declaration of "state of national emergency" by the Government, the psychological element of the possible responsibility ascribed to the healthcare worker should be limited to the hypothesis of wilful misconduct only.
In conclusion, the writer can only convincingly adhere to the blame manifested by many Forensic Orders in relation to illusory promises of easy compensation, for the damage caused by the Covid19 infection, which have circulated on the initiative of subjects perhaps not adequately prepared on the complex matter: a serious misinformation that generates confusion in a particularly delicate moment for the life of the country.
Citizens have a sacrosanct right to health protection and, when injured by the health care provided to them, they certainly have the right to recognition of this injury and to compensation for the damage: this, however, without making health workers "scapegoats" of a situation of general difficulty, danger and discomfort, which many commentators are comparing to a real war.