Paper Delivered To International Conference At the Coombe Hospital, Dublin, 13 May 2008 by Michael Boylan, Solicitor, Augustus Cullen Law

Historical Origins of the Doctrine:

Respect for an individuals right to autonomy has been an established human right continuing from the time of ancient Greek civilisation which has continued to influence contemporary medical ethics and law. For example, John Stuart Mill the 19th Century philosopher in his treatise “On Liberty”, in 1859 wrote:

Over himself, over his body and mind, the individual is sovereign.

Respect for autonomy was articulated in early 20th Century caselaw e.g. the classical statement by Cardozo J in Schloendorff v Society of New York Hospital (1914):

Every human being of adult years and sound mind has a right to determine what shall be done with his own body.

U.N. International Convention On Civil and Political Rights (1966) Art 7 states:

No one shall be subjected without his free consent to medical or scientific experimentation.

A Guide to Ethical Conduct and Behaviour – The Irish Medical Council (6th Edition 2004) para 17.1 states:

In obtaining consent the doctor must satisfy himself/herself that the patient understands what is involved by explaining in appropriate terminology. A record of this discussion should be made in the patient’s notes. A competent adult patient has the right to refuse treatment.

Thus informed consent is an important legal and ethical mechanism to ensure respect for patient autonomy in medical treatment. It is an integral part of the doctor’s duty of care in negligence tort law which co-exists with the duty to perform competent diagnosis and treatment.

Medical Paternalism

Up until recent years the standard of disclosure of risk/benefit that was adopted by the Irish Courts (in common with most common law countries) was the reasonable doctor approach (often referred to as the professional standard test).

As late as 1953 in our Supreme Court in Daniels v Heskin, an obstetric case involving a needle breaking whilst the Defendant doctor was stitching the Plaintiff’s perineum in the immediate post partum period the doctor did not inform the mother of what had occurred but decided to wait a number of weeks to see if the broken needle end worked itself out from the anatomy naturally. Remarkably, Kingsmill Moore J felt confident enough in the course of his Judgment to boldly state that doctors were free to disclose or withhold information in light of their impression of the patient’s character, education, social position, intelligence etc. He stated:

Any attempt to substitute a rule of law or even a rule of thumb or practice for the individual Judgment of a qualified doctor, doing what he considers best for the particular patient would be disastrous…. I cannot admit any abstract duty to tell patients what is the matter with them…. All depends on the circumstances – the character of the patient, her health, her social position, her intelligence, the nature of the tissue in which the needle is embedded, the possibility of subsequent infection, the arrangement made for future observation and care and numerable other considerations. In the present case the patient was passing through a post partum period in which the possibility of nervous or mental disturbance is notorious…. husband and wife were of a class and standard of education which it would incline them to exaggerate the seriousness of the occurrence and to suffer needless harm.

This undoubtedly was the high point of medical paternalism recognised in Irish jurisprudence.

Towards Patient Self Determination

Some 40 years later in Walsh v Family Planning Services (1992) the Supreme Court again considered the Doctrine of Informed Consent. McCarthy J questioned the sentiments expressed by Kingsmill Moore in Daniels v Heskins and the other Supreme Court Judges completely ignored the earlier decision. Walsh’s case concerned the Plaintiff’s allegation of undisclosed risk of chronic pain and impotence following an elective vasectomy. A second case of Bolton v Blackrock Clinic (1997) concerned laryngeal nerve damage warnings prior to sleeve resection surgery of the broncos. Both of these cases emphasised the need to obtain from the patient informed consent to treatment. In both of these cases the question of valid consent, including whether consent was indeed properly informed was to be assessed by the professional standard test of negligence pursuant to the seminal Supreme Court Judgment in Dunne v National Maternity Hospital (1989). In other words the Courts held that the patient must prove that the doctor was guilty of such failure (in the consent process) as no medical practitioner of similar skill and specialisation would be guilty of if acting with ordinary care. In summary, in both cases the Supreme Court favoured the reasonable doctor centred approach to the disclosure of risk/benefit. Thus the doctor only was obliged to disclose a risk to his patient that a reasonable doctor would deem necessary to disclose. In the event both Plaintiff’s lost their cases.

The Reasonable Patient Test

In assessing what risks should be disclosed to the patient so as to ensure a valid consent to treatment is obtained. Most common law countries have now moved away from the reasonable doctor/professional standard test. The notable exception is the UK which still persists with this approach. Since 2000 the Irish Courts have adopted the “reasonable patient test”.

In Geoghegan v Harris (2000) the Plaintiff claimed that had he known of the risk of chronic neuropathic pain during dental treatment he would have foregone the treatment. Kearns J held that a medical defendant was obliged to give a warning to the Plaintiff of any material risk according to what a reasonable patient would want disclosed and which is a known or foreseeable complication of an operation. It was held that the consent process was negligent as the aforesaid risk was a known complication. A warning of the risk was required. This was a radical change of approach for the Irish Courts. The Plaintiff however failed in his action as he could not prove that but for the negligent consent process he would not have had the treatment. In short it was held that even had a proper warning been given he would still have undergone the procedure.

In light of the Judgment in Geoghegan’s case Kingsmill Moore’s sentiments expressed in 1953 now sound as if they are from a bygone era reflecting the pre-eminent position of the doctor in the society of the time. No-one, not even the Supreme Court were happy to question to professional judgment of a doctor at that time. Thankfully, we now live in more enlightened times and the Courts have over the past 20 years moved radically away from the notion that “doctor always knows best” to embrace the concept of individual freedom of choice, autonomy and the patients right to self determination.

In Fitzpatrick v White (2007) the Supreme Court reinforced the objective reasonable patient test and applied it to elective treatment. The patient contended that the High Court erred in Law in holding that a proper warning had been given prior to cosmetic eye surgery of the risk of post operative double vision. The patient argued that the lateness of the warning, which was only given in the operating theatre rendered the consent null and void. The Supreme Court acknowledged that it was undesirable to give such a late warning as the patient may clearly be unable to make a rational decision due to nerves etc. In the event the appellant offered no evidence to show that he was unduly stressed. Therefore the Court found that in fact there was no negligence in the consent process. Moreover, similar to Geoghegan’s case the Court agreed with the Trial Judge that given the appellants motivation was an improved cosmetic effect he therefore would have undergone the surgery irrespective of the nature of the warning.

Consent Evidenced in Writing

A Plaintiff will find it hard to succeed in an informed consent action if the clinician can refer to written evidence documenting the consent process. This was clearly established in Winston v O’Leary (2006) where there was a dispute over the question of informed consent in relation to a vasectomy. The Plaintiff’s claim was dismissed in circumstances where the Plaintiff and her husband were relying solely on their respective memories of events which had occurred 17 years earlier. As against that the Defendant doctor had contemporaneous notes/aide-memoire from that time. McMenamin J was far more inclined to rely on the doctor’s version of events which was backed up by written contemporaneous notes/documentary evidence.

In summary therefore, the legal position is that the doctor is required by law and indeed medical ethics to obtain a competent adult patient’s voluntary and properly informed consent before treatment commences. The key requirement is to ensure that the patient properly understands the risk/benefit of the treatment. A doctor might be exposed to a successful medical negligence action centering on the issue of informed consent if the following three criteria are established by the dis-satisfied patient:

  1. Proper consent must be absent – i.e. the patient must prove to an objective reasonable patient standard that he/she did not truly consent and was not fully informed of the risk/benefit to the treatment.?
  2. The patient must prove the causal link between the failure to warn of the material risk and the damage suffered i.e. the Plaintiff needs to prove that had he/she known of the material risk he/she would not have consented to the treatment.
  3. The patient must show that the damage which was suffered was not too remote. The damage must be a consequence of the negligently obtained consent i.e. the breach by the clinician must result in the very risk/injury about which the patient was entitled to be warned. It follows therefore that if some unforeseeable risk eventuates that could not have been foreseen and about which no warning ought to have been given no liability attaches.

Autonomy And The Right To Refuse Medical Treatment

The right of patient autonomy is embraced in the constitution and the States duty to protect the person is embraced in Article 40.3.2. The right is also a dimension of the uninumerated right to bodily integrity recognised by our constitution (Ryan v Attorney General 1965 IR287). It follows that a competent adult with full capacity has an absolute right to decline medical treatment. That right of autonomy is not however without its limits.

In Re (a Ward of Court) withholding medical treatment (No 2) [1996] 2IR.79 Denham J defines the right to refuse treatment and the limits of that right as follows at page 156:

Medical treatment may not be given to an adult person of full capacity without his or her consent. There are a few rare exceptions to this e.g. in regard to contagious diseases or in a medical emergency where the patient is unable to communicate…. if medical treatment is given without consent it may be a trespass against the person in Civil Law, a battery in criminal law, and a breach of an individual’s constitutional rights. The consent which is given by an adult of full capacity is a matter of choice. It is not necessarily a decision based on medical consideration. Thus, medical treatment may be refused for other than medical reason, or reasons most citizens would regard as rational, but the person of full age and capacity may make the decision for their own reasons. If the patient is a minor the consent may be given on their behalf by parents or guardians. If the patient is incapacitated by reason other than age then the issue of capacity to consent arises.

Later in the context of discussing Article 40.3 of the constitution Denham J states:

The right to life is the pre-eminent personal right. The State has guaranteed in its laws to respect this right. This respect is absolute. The right refers to all lives – all lives are respected for the benefit of the individual and for the common good. The States respect for the life of the individual encompasses the right of the individual to, for example, refuse a blood transfusion for religious reasons. In the recognition of the individuals autonomy, life is respected.

‘Capacity’ To Refuse Treatment

Until the case of Fitzpatrick and another v K and another (25 April 2008) no Irish Court had had to consider previously how ‘capacity’ to refuse consent to medical treatment on the part of an adult should be tested. In that case as I am sure the delegates will appreciate a Jehovah Witness, who suffered a massive post partum haemorrhage after the safe birth of her child refused to accept a blood transfusion. In the event, fearing for her life, the hospital successfully applied ex-parte for injunctive relief to give a blood transfusion. Subsequently, these actions were challenged by the mother and a 35 day plenary hearing took place to consider the issues. The first core legal issue to be decided in the case was whether the mother had given a legally valid refusal of treatment. For a refusal of treatment to be valid it must be based on appropriate treatment information, be made by a person with the necessary capacity and be voluntary. In effect that particular case turned on whether the mother had capacity to make a decision to refuse at the time she articulated the refusal.

Laffoy J carried out a detailed analysis of the relevant law relating to capacity. She concluded:

It seems to me that the relevant principles applicable to the determination of the capacity question are as follows:

  1. There is a presumption that an adult patient has the capacity that is to say the cognitive ability to make a decision to refuse medical treatment but that presumption can be rebutted.
  2. In determining whether a patient is deprived of capacity to make a decision to refuse medical treatment whether –
    1. By reason of prominent cognitive impairment or
    2. Temporary factors for example factors of the type referred to by Lord Donaldson in Re T:

The test is whether the patient’s cognitive ability has been impaired to the extent that he or she does not sufficiently understand the nature, purpose and effect of the proffered treatment and the consequence of accepting or rejecting it in the context of the choices available (including any alternative treatment) at the time the decision is made.

  1. The three-stage approach to the patient’s decision-making process adopted in the C case is a helpful tool in applying that test. The patient’s cognitive ability will have been impaired to the extent that he or she is incapable of making the decision to refuse the proffered treatment if the patient:
    1. Has not comprehended and retained the treatment information and in particular has not assimilated the information as to the consequences likely to ensue from not accepting the treatment,
    2. Has not believed the treatment information and, in particular, if it is the case that not accepting the treatment is likely to result in the patient’s death has not believed that outcome is likely
    3. Has not weighed the treatment information, in particular, the alternative choices and the likely outcomes, in the balance in arriving at the decision.
  2. The treatment information by reference to which the patient’s capacity is to be assessed is the information which the clinician is under a duty to impart – information as to what is the appropriate treatment, that is to say what treatment is medically indicated, at the time of the decision and the risks and consequences likely to flow from the choices available to the patient in making the decision.
  3. In assessing capacity it is necessary to distinguish between misunderstanding or misperception of the treatment information in the decision-making process (which may sometimes be referred to colloquially as irrationality), on the one hand, and an irrational decision or a decision made for irrational reasons, on the other hand. The former may be evidence of lack of capacity. The latter is irrelevant to the assessment.
  4. In assessing capacity, whether at the bedside in a high dependency unit or in court, the assessment must have regard to the gravity of the decision, in terms of the consequences which are likely to ensue from the acceptance or rejection of the proffered treatment. In the private law context this means that, in applying the civil law standard of proof, the weight to be attached to the evidence should have regard to the gravity of the decision, whether that is characterised as the necessity for ‘clear and convincing proof’ or an enjoinder that the court ‘should not draw its conclusions lightly’.

The Duty Owed By The Clinician When A Patient Refuses Treatment

Denham J in the course her Judgment in Fitzpatrick v K states:

The duty of the clinician caring for a patient in the circumstances which prevailed in relation to Ms K on the morning of 21 September 2006 is to advise the patient of, and afford him or her, the opportunity to receive appropriate medical treatment. If as a competent adult the patient refuses to accept the treatment and no issue arises as to the capacity of the patient to make that decision, the clinicians duty to provide such treatment is discharged. However, if an issue arises as to the capacity of the patient to refuse treatment the duty of the clinician to advise on and provide the appropriate treatment remains. As a matter of law and common sense the duty of care which the clinician owes the patient in those circumstances is no different from what it would be if there was no refusal or if the patient was unconscious. What is required of the clinician is to take the steps to have the capacity issue resolved with the assistance of the Court if necessary. It follows that the assessment of the patient’s capacity to refuse treatment falls to be determined by reference to the clinicians responsibility to give the patient the relevant information in relation to the appropriate treatment and the risks attendant on the patient refusing the treatment.

When dealing with the facts of this particular case Laffoy J stated:

In this case the responsibility of the Master and the other clinicians treating Ms K was to give her the information that the appropriate treatment for her was a blood transfusion, as counsel for Ms K acknowledged. In layman’s terms the message was that the doctors’ opinion was that a blood transfusion was necessary and that without it she might die.

Laffoy J was satisfied on the evidence that a blood transfusion was necessary and was appropriate treatment for the mother. She was satisfied that the Master and the other treating clinicians gave the mother the necessary information to enable her to make an informed decision whether to accept or refuse a blood transfusion. However, the evidence in the case from the Master was to the effect that when he first decided to seek the authority of the Court to transfuse her that he had not come to a conclusion whether she lacked capacity to make a decision of such gravity as to refuse life saving treatment on religious grounds, nor had he come to a conclusion that she had such a capacity. The main thrust of the Master’s evidence was that having regard to all the circumstances he could not be certain that the mother had the capacity to refuse a blood transfusion.

Laffoy J continued:

I now turn to the kernel of the capacity issue, that is whether the evidence demonstrates that the Master and the other hospital personnel were objectively justified in doubting Ms K’s capacity.. the essential piece of information which Ms K had to assimilate and believe was that a blood transfusion was necessary and that without it she might die and the crucial question is whether she did so. ….. When the question is posed as to what she understood and believed on the morning of the 21 September 2006 it is not possible to conclude on the totality of Ms K’s own evidence that she understood and believed that without a blood transfusion she might die. Irrespective of that finding on the evidence adduced … the capacity question falls to be determined by reference to the evidence which was available to the hospital personnel and the court on the 21 September 2006. ….. I conclude that the Master and the hospital personnel should have doubted and genuinely did doubt Ms K’s capacity to give a valid refusal …. Ms K’s seriously compromised medical status following a long labour, difficult delivery and a massive haemorrhage; the communication difficulties created by the fact that Ms K’s first language was not English, the fact that she was a young woman in a foreign country whom the hospital personnel believed had no family members in the State ….. her understanding of her need for a blood transfusion; that if she died, on the basis of what she told the hospital personnel, her newborn baby would have no traceable next of kin and the whereabouts of the father would be unknown; and that by her disclosure after the haemorrhage, Ms K told the hospital personnel for the first time that she was a Jehovah’s Witness and would not take blood which was at variance with the Hospital’s understanding that she was a Roman Catholic which was based on the information she gave when booking. All of those matters, in my view put the hospital personnel on inquiry as to whether Ms K’s refusal was valid.

Balancing The Rights Of The Mother and Those Of the Foetus/Child

In obstetric medicine respect for autonomy may conflict with the right to life. This dilemma can occur in foetal medicine where potentially the mothers right to autonomy could conflict with the rights of the foetus/unborn child. Primacy must be afforded to the right to life (maternal and foetal). The issue of balancing the potentially competing rights of a competent mother to autonomy and the rights of the unborn child was not dealt with in Fitzpatrick v K. As Laffoy J stated:

There was consensus that the balancing of rights question would only arise in the event that the Court were to find that Ms K had full capacity to make a decision to refuse a blood transfusion. On the basis of the finding that Ms K did not have capacity to make that decision the balancing of rights question does not arise. For the Court to express a view on it would in effect amount to an advisory Judgment on an issue which has been rendered moot by the decision on the capacity question.

Article 40.3.3 para 1 of the Constitution reads:

The State acknowledges the right to life of the unborn and with due regard to the equal right to life of the mother, guarantees in its laws to respect, and as far as practicable, by its laws to defend and vindicate that right.

The doctor clearly therefore owes duties to both the mother and the foetus. It is submitted that the obstetrician must respect within reason the autonomy of the mother and the right to life of the foetus. This principle applies irrespective of foetal viability and can only be compromised when there is material risk to maternal life. The Supreme Court in AG-v- X (1992) acknowledged the equal right to life of the mother and the unborn.

It is noteworthy that a recent study of physicians and nurses attitudes towards neonatal ethical “end of life” decision making funded by UCC noted that 77% of Irish physicians disagreed with the notion that:

Because human life is sacred everything possible should be done to ensure a neonates survival, however severe the prognosis.

It is submitted that foetal medicine must strive to find a balance between maternal autonomy whilst still protecting the right to life of the foetus. There is often no clear answer when conflict arises, particularly in an emergency intrapartum setting.

In North Western Health Board v HW and CW (2001) the Supreme Court held that parents may refuse medical treatment for their child if the treatment is elective and non life saving. The parents refused to consent to a PKU test for their children. This was challenged by the Health Board. Denham J found that the PKU test was invasive and therefore the consent of the parents was required. Denham J afforded primacy to the family unit pursuant to Article 41 of the Constitution. Moreover integral within the family unit is the independent rights of the child. The Courts will only intervene pursuant to the Constitution when the parents fail to act in the child’s best interests.

POSSIBLE FUTURE DEVELOPMENTS

Vaginal Birth After Caesarean Section (VBAC)

In the recent case of Amanda Fogarty v The Rotunda Hospital (Irish Times 27 February 2008) the Plaintiff alleged she was not informed about the risk of vaginal delivery subsequent to a previous caesarean section. The Plaintiff infant was born with severe brain damage in July 2003 allegedly after the mother’s uterus ruptured whilst in labour with her second child. The mother alleged that she was never informed in the ante-natal period of the serious maternal risks to her foetus and her own health from uterine rupture if a vaginal delivery was attempted after a previous caesarean section. It was further alleged that uterine rupture occurred due to mis-use of Syntocinon. The case settled for 3 million euro and costs without an admission of liability.

Birth Plans

It has not quite happened yet, but I predict that there will soon be a case where the modern development of expectant mothers drawing up a detailed explicit birth plan as to how they wish their labour to be managed will create a conflict and dilemma for midwives and obstetricians charged with managing a dynamic labour. Unless these plans are discussed in detail before labour begins or at least at the start of labour issues of informed consent will certainly arise if the staff ignore the birth plan without proper explanation/consent. Of course, if an obstetric emergency arises it may be vital for the staff to depart from or ignore the mother’s birth plan in the best interests of the foetus. I preface my remarks on birth plans by saying it hasn’t quite happened yet but it was a near miss issue in the recent birth injury case of Fitzpatrick v National Maternity Hospital which I will be dealing with later this morning.

I can foresee that consent issues would arise if the mother’s birth plan was in clear conflict with hospital policy. For example if the mother explicitly states on her plan that she does not desire to have oxytocin and/or episiotomy and/or the use of forceps. In such circumstances it is absolutely vital that a detailed discussion would occur well before an emergency situation arises as minutes wasted in explanation to the mother in the midst of an obstetric emergency could have disastrous consequence.

Use of Oxytocin

Will it ever or does it now require written informed consent to the use of Oxytocin in labour? I know it is not the practice of any maternity hospital in this country to my knowledge to seek written consent for the use of this drug. I simply pose the question – should written consent be sought from the expectant mother? Over the past 20 years the number of cases that I have dealt with involving damage caused by the use of Oxytocin is numerous. I read an article recently from the British Journal of Obstetrics and Gynaecology which showed that in Sweden 71% of cases of severe intrapartum asphyxia were caused by misuse of Oxytocin. Is there not a logical basis therefore to seek patient consent before it is administered at all?

Use of Forceps

Obviously lift out forceps or ventouse in the second stage of labour would usually be a much quicker and therefore the optimum method of delivery in an emergency situation rather than organising a caesarean operation. However when time permits would there not be a question about whether a caesarean operation would be the better option rather than use of forceps? Is there not a significantly increased risk of maternal morbidity arising from use of forceps e.g. tears, trauma and urinary incontinence, never mind increased foetal morbidity associated with forceps use? I simply pose the question.

Water Births

I know from my own personal knowledge that the use of birthing pools have been suspended in Cavan General Hospital following a tragedy which occurred there over 2 years ago and which is still the subject matter of a lengthy ongoing inquest before the Dublin City Coroner. I do strongly believe that issues of informed consent must arise when birthing pools are being used. There is literature available from reputable obstetric and paediatric journals which clearly shows that there are added risks associated with water births that don’t exist with birth on dry land including drowning and subsequent brain damage. It therefore seems to me that it is a “no-brainer” that before any mother would contemplate a water birth she should be fully informed of all material risks so that she can make an informed choice before “taking the plunge”.

Conclusion

Medicine, like law is not an exact science. Therefore in obstetric treatment where autonomy is necessarily compromised due to an emergency, mental incapacity or age it is reasonable to assume that the Courts are likely to afford considerable latitude and respect to the clinicians decision and will decide the standard of disclosure that is required on a case by case basis. In my view great respect is likely to be given to the obstetrician or midwife whose decision is made in an emergency situation as to whether or not maternal autonomy is to be placed secondary to the interests of the foetus. Recently two eminent obstetricians, one English and one Irish gave evidence to the High Court in a case and unequivocally, stated that in a hypothetical situation in the interests of foetal welfare and to avoid potential long term neurological damage they would perform an episiotomy to expedite delivery even against the express wishes of the mother. As one of the doctors eloquently put it: “I would cut first and discuss it later on the basis that it is often easier to ask for forgiveness later than permission in advance.” His evidence to the Court was received with great sympathy by the Trial Judge.

However there is no doubt that a clinician is under a legal and ethical duty to obtain a patient’s free and informed consent to treatment. Adults with cognitive capacity may legally and morally choose to waive the right to medical treatment be it for reasons we can agree with, understand or not. The doctrine of informed consent is the legal mechanism to ensure respect for autonomy. Respect for autonomy however is multi-factorial. It is not an absolute and unlimited right. It must be exercised in a reasoned manner. Autonomy may be over-ridden in emergency treatment when the best interest of the patient/s (mother or child) so requires it.

Michael Boylan, Head of Medical Negligence Group → michael.boylan@aclsolicitors.ie

04 November 2008

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