Legal guardians and refusal of blood transfusion

Introduction: the case

A patient with k light chain multiple myeloma was sent by her General Practitioner to the Emergency Department because of severe anaemia (last haemoglobin 6.0 g/dL) and a fall to the ground that had caused trauma to the left knee and left periorbital ecchymosis. On entry to the Emergency Department the patient was found to have a haemoglobin concentration of 6.1 g/ dL. Being a Jehovah’s Witness, the patient refused a transfusion of red cell concentrates despite repeated discussion with the doctors in which the real and imminent risk of loss of consciousness and death was explained. Four days later, despite bone marrow stimulating treatment with high doses of erythropoietin (Eprex 10000 UI 3 times/week), there had been a progressive fall in the haemoglobin concentration (haemoglobin 4.4 g/dL). A person claiming to be the patient’s Guardian presented at the ward, giving the doctors an “application for the designation of temporary guardianship and emergency measures ex article 405 section 4 Civil Code” in order to safeguard, by confirming them, the wishes expressed by the patient who at that time was still conscious, lucid and demonstrated understanding of the risks related to her refusal of transfusions.

Using the above case as a starting point, we, who were consulted about it in the quality of advisors for the University Hospital, analyse the medico-legal issues related to the powers of the new judicial figure introduced with Law 6/2004 of the Italian Civil Code.

Refusal of transfusion for religious reasons: medico-legal aspects

The punctum dolens of the refusal to receive blood transfusions by Jehovah’s Witnesses has been particularly relevant from a legal point of view, being an issue of great importance and always of topical interest deriving from the relation between life-saving healthcare treatments and the religious beliefs of a patient.

In particular in an ideological and jurisprudential context ever more oriented towards defending the right to health, intended also as freedom of choice and individual self-determination, the conflict between an ethical and legal duty to safeguard life and the constitutionally guaranteed right to decide freely about healthcare treatments continues to be an unresolved problem.

In fact, Jehovah’s Witnesses, translating the biblical prohibition to eat blood to transfusions, believe that receiving blood in this way would break divine law and cannot be a morally acceptable means of ensuring health¹.

According to predominant doctrine, giving a transfusion against the wishes of a patient is an illegitimate act violating article 32 of the Constitution, in that no-one can be obliged to receive transfusion treatment.

Furthermore, even with a view to future interventions by legislators on this matter, a possible regulation imposing the acceptance of transfusions by Jehovah’s Witnesses would be unconstitutional, by contrasting “not only with the freedom of conscience, but also with the principle that obligatory healthcare treatments cannot be aimed at safeguarding only a person’s physical health and cannot be carried out coercively in a specific form²”.

The situations that can occur in clinical practice are those in which the doctor needs to administer transfusion therapy to an adult Jehovah’s Witness who is of sound mind and who personally refuses the treatment and those in which the patient, for various reasons, does not have the capacity to express his or her own wishes.

In the last 20 years there has been a complete review of the concept of lawfulness of medical acts, with the emergence of the right to freedom to knowledgeably refuse a healthcare treatment, even when it is necessary to maintain life³.

In this sense, now well-consolidated jurisprudence confirms that a doctor does not have a general right to treat, against which the wishes of the patient would have no relevance, in that medical practices require the consent of the patient to be lawful (Sentence from the Court of Cassation, Criminal Section IV, 14 March 2008, n. 11335).

Thus, faced with a refusal of treatment by the very person for whom it is intended, there may be room for a strategy of persuasion, and before that, verification that the refusal is informed, real and current; however, if the refusal does have these characteristics, it cannot be disregarded (Sentence from the Court of Cassation, Civil Section I, 16 October 2007 n. 21748) and to do such would place the doctor in a situation of committing a crime (article 610 Criminal Code - Assault – incorporated by the sentence from the Court of Cassation, Criminal Section I, 11 July 2002, n. 3122).

As a result of this evolution, a firm point has finally been reached in the very personal right to knowledgeably refuse healthcare treatments: “... a patient must be recognised to have a real and true right to be not treated, even if this conduct places his or her life at risk .. therefore, any hypothesis of compulsory blood transfusion would be … illegitimate because it would violate constitutional law on the freedom of conscious and the incoercibility of individual healthcare treatments ...” (Sentence from the Court of Cassation, Civil Section III, 15 September 2008, n. 23676).

With regards to patients who do not have the capacity to make a decision, or who are unconscious, a clear distinction must be made between those cases in which the patient has not expressed any type of wish and those in which she or he has done so.

In cases in which there is no knowledge of any wishes expressed by the patient before he or she lost consciousness, the process for deciding the treatment that the patient should receive is inevitably entrusted to the doctor who, in cases in which there is “an existing risk of severe harm to a person” can, and indeed should, act under the protection of the extenuation in article 54 of the Criminal Code. (Criminal Code, article 54 – State of necessity -: “ A person is not punishable for having committed an act that he was forced to do in order to save himself or others from an existing risk of severe harm, a risk not voluntarily caused by him, nor otherwise avoidable, always provided that the act is proportional to the risk”).

It should be made clear that, in these cases, family members, in this role alone, do not have decision-making powers for their own relative, although their involvement is necessary to collect the information needed for the medical intervention to be as coherent as possible with the personality of the person being treated.

In the case in which the patient has, however, expressed a wish to refuse some kinds of healthcare treatment necessary for his or her survival, an evaluation must be made not only of the condition in which the patient was and is and the way in which the refusal was expressed, but above all, careful consideration must be given to whether the requisites for the refusal still being current are present or not.

With regards to a written refusal of transfusions, part of the jurisprudence considers that a person who gives a transfusion to an unconscious patient, who carries written dissent to such treatment, without there being a state of necessity will have to pay damages for “moral/existential harm” because the transfusion “offends and affects the being of a person”, whose personal identity includes the religious precepts harmed by the healthcare staff (Sentence passed at Pordenone, 11 January 2002, in Nuova Giu. Civ. Comm., 2002, 664).

According to another jurisprudential approach, since the requisites for consent to be valid include that it is up-to-date and personal, a statement made previously by a patient “is not an effective expression of will”, because it reflects a choice that is “not concrete, but abstract, not specific, but programmed, not informed, but ideological, and, above all, past, previous and not current” (Sentence from the Court of Appeal, Trieste, 25 October 2003, in Nuova Giu. Civ. Comm., 2005, 148).

This situation would, therefore, render a statement of wish invalid, since, just as consent cannot be given preveniently and must, therefore, follow the occurrence from which the need for a certain treatment derives, in the same way a refusal cannot be validly expressed before an emergency and regardless of it.

This interpretation considers not current both a statement of wishes contained in a document prepared long before the event requiring its use and the refusal expressed by the “No Blood” card that many Jehovah’s Witnesses carry for the purpose of continuously confirming their persistent refusal of transfusion therapy⁴.

In this regard, the Supreme Court has recently come to an analogous conclusion, defining that refusal of treatment previously expressed by a patient is not legally binding and, therefore, that the act performed to safe the life and health of an unconscious patient from an existing risk of harm is legitimately extenuated ex article 54 Criminal Code.

In particular, the Court of Cassation, Criminal Section IV, 18 May 2006, n. 16995 sentenced: “...The healthcare worker need not take into consideration a document in which a patient refuses transfusions, even in an urgent case of need, for two reasons: both because there is a state of necessity that would impose the performance of the transfusion; and because, anyhow, the previously expressed refusal cannot legally bind the doctor, being an expression of will made without the indispensible requisite of being current...” and, in agreement with this, the Court of Cassation, Civil Section III, with the sentence of 23 February 2007, n. 4211 entered into the issue further, emphasising: “...This is the problem to resolve: not about the absolute and definitive value of a refusal made as a result of a given ideological and religious belief, but the correctness of the justification ... that the original refusal should not be considered in effect at a subsequent time, in the face of a radically changed clinical situation and imminent risk of death and without the possibility of further consulting this patient ... this justification is not invalidated by errors of right, because it respects Law 28 March 2001 n, 145, which, in article 9, establishes that “wishes concerning a medical intervention previously stated by a patient who, at the time of the intervention, is not able to express his or her will, will be taken into consideration” the issue under examination concerns the refusal of treatment, but not in the sense of pronouncing on the legitimacy of the right to refuse blood transfusions, even if this leads to death, but more limitedly, to ascertain the legitimacy of the behaviour of healthcare staff who have given a transfusion in the reasonable belief that the patient’s original refusal was no longer valid and in effect ...”.

It is, however, not equally clear how a doctor should behave faced with a case, such as the one described above, in which the patient knowledgeably refuses a transfusion and refers every decision, in the case of future incapacity, to a “representative ad acta who, having demonstrated the existence of his power of attorney…, confirms this refusal after having received information from the healthcare staff” as recently put forward by the Supreme Court (Sentence of the Court of Cassation, Civil Section III, 15 September 2008, n. 23676).

On this background, we describe the figure of a Guardian, introduced by Law n. 6 of 9 January 2004.

Guardianship and instructions in advance

The issue of consent to healthcare treatment entrusted to a Guardian is of considerable interest and notable potential for application, given the substantial number of people who, for physical or mental reasons, find themselves completely, partially or temporarily incapable of taking care of their own interests (Civil Code, article 404 -: Guardian -:”A person who, for reasons of infirmity, that is, a physical or mental disablement, cannot, also partially or temporarily, take care of his or her own interests, can be assisted by a Guardian, appointed by the tutelary judge in the district where the person resides or is domiciled”).

There is wide consideration that Law n. 6 of 2004 is an excellent response to the need to fill the legislative lacuna in the field of relations between healthcare staff and patients unable to provide truly knowledgeable consent⁵.

The introduction into the Italian system of regulations of this new measure of protection for persons lacking the capacity for self-determination has led to an extension of guardianship, also with regards to healthcare decisions.

This innovation seems to have been very favourably welcomed by tutelary judges, as demonstrated by the widespread application of medical guardianship.

Among the first cases concerning guardianship of an incapable patient, the ruling made by the Court of Modena, 15 September 2004, relating to a person with chronic delirium and a form of diabetes, stands out⁶.

The tutelary judge, after having checked that the subject did not have relatives and did have a clinical picture of delirious ideation, appointed a Guardian (the judge always orders that the Guardian provides a written report on the conditions of health of the beneficiary within 1 month of appointment). In order to ensure the care and assistance of the beneficiary, the judge also authorised the Guardian to express, on behalf of the beneficiary, informed consent to proposed therapeutic interventions and their consequences.

This ruling represents one of the first pronouncements clearly stating the principle that the power of attorney, set out by Law n. 6/2004, is not limited to the spheres of finance and patrimony, but extends to the needs and aspirations of the person, including every aspect of civil life.

In the case of a person under guardianship, the beneficiary, usually, retains full capacity for all acts for which exclusive power of attorney has not been conferred and, therefore, also for healthcare decisions.

In fact, it should be remembered that article 409, first section, Civil Code, states that “the beneficiary conserves the capacity to decide about all acts that do not require the exclusive deputation or necessary care of the Guardian”.

It should be held fast that, at the time of appointment, or even subsequently, the tutelary judge can establish that these decisions are to be made by the Guardian (Sentence from the Court of Modena, 28 June 2004, in Gius, 2004, p. 3939). According to this sentence “the Guardian can be authorised by the tutelary judge to give informed consent to a therapeutic surgical intervention to which the incapacitated person must be subjected, when this latter refuses to undergo the intervention despite not having the awareness of his or her pathological condition or of the consequences of not accepting the treatment”.

Along the same line, the Court of Rome, 22 December 2004, observed that “when the will of the beneficiary is invalidated by a specific pathology that prevents a correct representation of the therapeutic intervention and its consequences, it is the Guardian who must express informed consent to the use of invasive treatments or ablative interventions”.

Article 410, second section of the Civil Code, sets out that decisions of a personal nature, and all the more so those concerning health, should, as far as possible, be the result of agreement between the beneficiary and the Guardian.

On this background, it is necessary to consider in more depth the situation in which a person needing guardianship loses consciousness.

In this case, in fact, the Guardian’s decisions should respect the beneficiary’s personality and, possibly, take into account the person’s previously expressed wishes (Civil Code, Article 410, first section: “in carrying out his or her duties, the Guardian must take into account the needs and aspirations of the beneficiary”).

Focusing on the specific case of Jehovah’s Witnesses, there are some sentences in which a Guardian was appointed in order, in agreement with the beneficiary’s wishes, to refuse blood transfusion (Sentences: Court of Vibo Valentia, 30 November 2005; Court of Rome, 21 December 2005; Court of Treviso, 9 February 2006).

One particularly significant ruling was made by a tutelary judge of Rome, 21 December 2005, regarding a request by a son to be appointed Guardian of his father, a minister of a Christian Congregation of Jehovah’s Witnesses, admitted to hospital in a coma. The claimant argued that the request was particularly urgent because of the total incapacity of the interested subject to express his own desire not to receive blood transfusions.

Having documented the previously expressed wishes of the patient, the judge nominated the son as his father’s Guardian in order that the father’s previously expressed wishes were respected. This measure picked up article 34 of the Medical Profession’s Code of Conduct, according to which “if a patient is not capable of expressing his or her own wishes in a life-threatening situation, the doctor cannot ignore the previously expressed will of the patient” (Oviedo Convention, Article 9: “The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account”).

Furthermore, article 410, first section of the Civil Code, states that “in carrying out his or her duties, the Guardian must take into account the needs and aspirations of the beneficiary”.

These recent directions have also be re-inforced by the Supreme Court of Appeal (Sentence of the Court of Cassation, Civil Section III, 15 September 2008, n. 23676), which, although confirming that “in the hypothesis of a severe and imminent risk to the life of a patient, this person’s refusal of treatment must be expressed, unequivocal, current and informed”, nevertheless suggested that in such situations “it is undeniable that the person refusing transfusion treatment must be either the patient him- or her-self who carries an argued, precise, expressed statement unequivocally demonstrating the desire to prevent transfusion treatment even in a life-threatening situation, or another person indicated by the patient as a representative ad acta, who, having proven his or her power of attorney over this situation, confirms the refusal after having received information from the healthcare staff”.

Confirmation of the fact that a Guardian, as “representative ad acta” can be a guarantor of the refusal expressed by a patient “now for then” emerges from a sentence passed by a tutelary judge in Modena on 5 November 2008 which emphasised that “the appointed Guardian could ... deny consent to certain treatments ... When there has not be a revocation, and given the contingencies outlined in the written statements, the wishes expressed should be respected since the objection of a possible and not manifested change of mind at the moment of slipping into the expected state of unconsciousness is juridically inconsistent with the principle consolidated from time immemorial in the legal system by which a freely determined will, in being such is appropriate for producing juridical effects, remains constant until its revocation”.

Conclusions

From an analysis of the evolution of Italian Civil and Criminal jurisprudence, a fairly clear orientation seems to be emerging according to which the doctor, faced with a conscious patient who expresses informed, unequivocal and current refusal of a medical treatment, even when this is life-saving, must respect the patient’s wishes, since the fact that death is generally considered a negative event cannot obstruct or render null the legitimate exercise of a person’s right to refuse healthcare, according to which no-one can be forced to undergo healthcare treatments against their will, except as laid out by law (Article 32, Italian Constitution, second section); while in the situation that a patient is unconscious or incapable, if there is a serious and existing threat to the person’s survival, it becomes legitimate and professionally right and proper to intervene with all means necessary to save life (Article 54 Criminal Code).

However, the limitation of this compromise is exposed when faced with an unconscious person who has previous expressed his or her will, also documenting it, with regards to the acceptance or refusal of healthcare treatments.

This situation, which occurs very frequently in the case of refusal of blood transfusions by Jehovah’s Witnesses, has led to lively debate on the so-called “instructions in advance”, their effectiveness and who can guarantee a decision taken “now for then”, in the context of a legislative lacuna in the matter combined with the inevitable intermingling of considerations of an ethical nature and reflections of a more purely legal type.

The new figure of Guardian erupted into this confusing scenario. This figure, on the basis of the interpretation of both article 408 of the Civil Code (“The Guardian can be nominated by the person interested, in anticipation of his or her possible future incapacity”) and article 410 of the Civil Code (“in carrying out his or her duties, the Guardian must take into account the needs and aspirations of the beneficiary”), seems to be able to rise to the role of guarantor of previously expressed wishes, even when these concern the refusal of life-saving treatments.

However, it should be emphasised that, in situations such as the case in discussion, the healthcare professional should proceed with care, first verifying the effective appointment as Guardian of the person claiming to be such and the extent of the powers conferred to the Guardian by the tutelary judge, in particular to whether these extend to expressing refusal on behalf of the beneficiary.

In second place, in compliance with good medical practice⁷, it is essential that the real state of incapacity of the patient is verified, by appropriate psychiatric or medico-legal consultations, and that there is a concrete risk to life that implies a true state of therapeutic necessity.

The importance of correct information on the patient’s clinical condition and prognosis and the duty to try to persuade the patient concerning the life-saving treatment must also be highlighted.

In cases in which, despite all the forgoing, the refusal of the “legal representative” persists, and a difficult ethical-juridical situation is developing, it seems appropriate to consult a tutelary judge, the only figure effectively able to decide about the validity and incontrovertibility of the previously expressed wishes that the Guardian is guaranteeing (Civil Code: article 405: “... Whenever necessary, the tutelary judge can take, in his official capacity, urgent measures for the person involved ...” article 407 “... The tutelary judge can, at any time, modify or integrate, in his official capacity, the decisions made at the time of appointing the Guardian...”).

In conclusion, it can be said that, at present, there is the right to refuse treatment preveniently, even in the hypothesis that such treatment would be indispensable to save the interested subject’s life.

In this case, the doctor, although being in the paradoxical situation of risking, in the face of not carrying out an intervention, being tried for murder⁸ or assault⁹, if he or she decides to intervene (in which case he or she will also have to pay damages¹⁰ for violating the freedom of self-determination of the person treated), the doctor must assume the responsibility for his or her choices, always remembering that, unfortunately, “law intervenes, in this field, a posteriori, to evaluate ‘with hindsight’ (and with almost unpredictable outcomes) the significance of the event”¹¹.