By Ruwan Laknath Jayakody –

Ruwan Jayakody

For patients in Sri Lanka, the medical profession, for the most part, unless due to ignorance or naivety concerning the complexities of diagnosing and treatment, or some genuinely ghastly tale of horror and woe experienced at the hands with the healing touch, generates reverence and to its practitioners, especially the doctors, is bestowed godlike status, and afforded godly veneration with all the associated spoils. Thus, any breach of this duty of care, is deemed tantamount to a mortal sin. A crisis of this magnitude is presently unfolding in two State/Government Hospitals in the Kurunegala and Dambulla areas, where a doctor is alleged to have performed a procedure on hundreds of women seeking to be mothers for the second time, which rendered them sterile and thus unable to conceive a second time. Whilst a criminal investigation is presently underway and a full blown political and media circus is in parallel going gung ho, all guns blazing, the situation beggars a long term solution for the health care service sector in general, a solution which lies in informed consent.

The adoption by the Lankan judiciary of the relevant principles expounded in Montgomery v. Lanarkshire Health Board decided by the Supreme Court (SC) of the United Kingdom (UK), primarily that of informed consent, will not only help to protect patients autonomy and their right to self determination but also increase healthcare standards and preserve the medical profession’s sanctity. This latter view was put forward by legal researcher G.D. Gunawardena in his research paper ‘Implications of adopting the principle of Informed Consent in Sri Lankan Medical Malpractice law: A critical analysis in light of Montgomery v. Lanarkshire Health Board (2015) UK SC 11’, in which he added that it is high time for legal reform or at least judicial review through the expansion of the prevailing principles to afford more predictability and certainty to the law.

Background 

Gunawardena had also interviewed, for the purpose of this research, five practicing doctors, two final year medical students and persons involved in hospital administration. He noted that the said doctors had stated that they usually encountered problems when communicating with the older population of the lower class while on the other hand, youth from the same social class were quite competent with regard to these matters and even those who were less so would understand a procedure once time was taken to explain it to them in simpler terms. The doctors, Gunawardena observed, also indicated that presently, there is increased concern on the part of patients with regard to what treatment is performed and also that they expect a higher standard of care, especially in the private sector.

Further, Gunawardena’s interviews with the practicing doctors revealed that most just mention the name of the procedure or explain it in a single sentence before asking the patient to give their written consent. The doctors had argued that a detailed explanation would prove redundant because a majority of patients in Sri Lanka would not understand and also that such an explanation would usually scare a patient into refusing even low risk treatment. 

Informed consent: The applicable legal regime  

On consent and bodily integrity, physical autonomy and the right to self determination, Justice Benjamin Nathan Cardozo, when in the New York Court of Appeals, in the case of Schloendorff v. Society of New York Hospital (1914) 105 N.E. 92 211 N.Y. 125 wrote that “Every human being of adult years and sound mind has a right to determine what shall be done with his/her own body and a surgeon who performs an operation without his/her patient’s consent, commits an assault”. Incidentally, the Nuremberg Code’s first point when conducting permissible medical experiments is that voluntary consent of the subject is absolutely essential.

Informed consent, on the other hand, as Professor Paul Stuart Appelbaum observed in ‘Assessment of patient’s competence to consent to treatment’, is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. The 1972 United States Court of Appeals for the District of Columbia Circuit case of Canterbury v. Spence (464 F.2d. 772. 782), Judge Spottswood W. Robinson the III was of the view that a doctor must disclose all risks which might materially affect a patient’s decision and thereby founded the doctrine of informed consent in law for the first time even though the jury’s verdict was in favour of Dr. Spence, where the doctor in question had taken the position that the disclosure of minute risks of complication was not sound medical practice since it potentially deterred patients from availing of necessary surgery and had thereby only informed Canterbury that the surgery might result in weakness and omitted to mentioned paralysis, avoiding the more specific warning so as not to deter the patient from pursuing the operation.

According to Thomas A. Moore’s ‘Informed Consent, Part 2’, a claim based on the absence of informed consent requires that 1) the physician did not present the risks and benefits of the proposed treatment and alternative treatments, (2) the patient would have declined the treatment if in possession of complete information, and (3) the treatment, even though appropriate and skillfully carried out, was a substantial factor causing the patient’s injuries. As Jonathan Herring in ‘Medical Law and Ethics’ observed, “The issue is not whether enough information was given to ensure consent to the procedure, but whether there was enough information given so that the doctor was not acting negligently and giving due protection to the patient’s right of autonomy”.

Susan Schmerler identifies the five elements of informed consent as 1) competence (the legal capacity of a person to make a rational choice, the ability to comprehend medical information and the consequences of decisions, and the ability to communicate decisions), 2) the amount and the accuracy of information (inheritance of condition, patient specific risks, potential benefits, limitations of all management options, and available alternatives), 3) patient understanding (it is the responsibility of the health care provider to identify and attempt to overcome barriers such as fear or denial, illness, lack of education or reduced cognitive ability, cultural considerations, unscientific beliefs and family myths, and language barriers), 4) voluntariness (the patient has to make a personal decision without coercion and cannot simply yield to the suggestion of a family member, doctor, or any other individual), and 5) authorization (the patient should actively agree to a course of action and that decision should be documented).

In ‘Informed Consent. Effective Communication: A Necessary Prerequisite?’, Des McMahon explained that simply put, if the patient does not understand or appreciate the implications and consequences of a consent, or if all necessary facts have not been made available to him/her, then the consent is not an informed one. Furthermore, informed consent, she added, is more than a form but a process that includes discussion (frank and open dialogue with patients, providing an opportunity for the doctors to establish a rapport with, and engage patients in making decisions about their own care), education (educational pamphlets, videos, handouts, and pre/post-treatment instructions will help patients make an informed decision and remember what they have consented to should any complications occur as these materials are usually much easier for patients to understand and are less intimidating than most consent forms), and obtaining written consent (the consent form should provide written information that will help patients remember the risks, benefits, and alternatives that have been discussed, and also serve as documentation of the discussion).

Deirdre Duffy and Jamie Woodcock’s ‘The Evolution of the law on Patient consent’, noted that the SC of Ireland in Fitzpatrick v. White (2007) IESC 51, in an opinion by Ex Officio Member, Justice Nicholas Kearns with Justice Fidelma Nora Macken and Ex Officio Member, Justice Joseph Gerald Finnegan agreeing, reinforced the application of the reasonable patient test which requires the full disclosure of any material risk according to what a reasonable patient would want.

The Malaysian Federal Court of Putrajaya in Foo Fio na v. Dr. Soo Fook Mun and Assunta Hospital (2007) [Civil Appeal 02-20-2001 {W}], as Muditha Vidanapathirana in ‘What Do We Know About Medical Negligence?’ pointed out, decided that the reasonable patient test should be applied to assess all forms of medical negligence.

Montgomery v. Lanarkshire Health Board was a unanimous ruling by a seven Judge bench with Justices, Lord Brian Francis Kerr of Tonaghmore, Lord Robert John Reed (currently the Deputy President of the Court) and Deputy President of the Court, Lady and Baroness Brenda Marjorie Hale of Richmond (currently the President of the Court) writing opinions, which led to the awarding of damages to the tune of Sterling Pounds 5.25 million to the claimant Nadine Montgomery, whose baby suffered severe brain damage and disabilities owing to a Member of the Hospital Board (a doctor), failing to disclose that there was a nine to 10 per cent risk of shoulder dystocia (the inability of the shoulders to pass through the pelvis) during vaginal delivery by such diabetic mothers (Montgomery suffers from insulin dependent diabetes mellitus). On the facts of the case, Gunawardena writes that this doctor’s policy was not to advise diabetic women about shoulder dystocia as, in her view, the risk of a grave problem for the baby was very small. An alternate to vaginal delivery was a caesarean section. During the delivery however, as a result of shoulder dystocia, the baby was deprived of oxygen for 12 minutes and sustained injuries. 

The law as per Montgomery v. Lanarkshire Health Board requires that a doctor must take “reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments”. And as Gunawardena added, for the Court, materiality was to be judged by reference to the individual circumstances of the case and whether a reasonable person in the patient’s position would be likely to attach significance to the risk, or whether the doctor is or should be aware that the particular patient would be likely to attach significance to it. The Court had also warned doctors against bombarding the patient with technical information which they would not be able to comprehend and routinely requiring them to sign a consent form.

It is now accepted that a patient should have adequate knowledge regarding a procedure and the right to decline it even though the risk is almost negligible in the doctor’s eyes, he added.

In the words of Lord Kerr – “The assessment of whether a risk is material cannot be reduced to percentages” while Lady Hale noted that “A patient is entitled to take into account her own values and assessment of the comparative merits, whatever medical opinion may say”.

Therefore, the doctor’s role in an advisory one, the Court held, added that it “involves dialogue, the aim of which is to ensure that the patient understands the seriousness of his/her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that he/she is then in a position to make an informed decision”. 

Objections 

The Court also observed arguments likely to be put forward against the informed consent approach where they noted that some patients would rather trust their doctor than be informed of all the ways in which their treatment might go wrong as they believe the doctor knows best. Exceptions, according to the Court, where legal obligation for such disclosure of risks (including risks inherent in treatment) is not necessary is “with a patient who makes it clear that he/she would prefer not to discuss the matter or know the risks” and if “in the reasonable exercise of medical judgment, the doctor considers that it would be detrimental to the health of the patient”. 

Another objection includes the fact that it is near impossible to discuss the risks associated with a medical procedure within the time typically available for a health care consultation. The Court proposed that “it is nevertheless necessary to impose legal obligations, so that even those doctors who have less skill or inclination for communication, or who are more hurried, are obliged to pause and engage in the discussion which the law requires”.

Further objections are that these principles would result in the practice of defensive medicine (where a diagnostic test or medical treatment that is not necessarily the best option for the patient would be recommended as the said option mainly serves the function to protect the physician against the patient as a potential plaintiff), and that litigation will increase. The Court dispelled these arguments claiming that a system which requires the patient to make the ultimate choice would actually be less likely to encourage litigation than a system where the patient relies solely on his/her doctor’s decision, and that doctors would be under a lesser threat of litigation once consent has been obtained, and also that if a patient makes the final call in consenting, he/she will be less likely to sue. Gunawardena pointed out that obtaining such consent would enable the doctor to plead the defense of ‘volenti non fit injuria (voluntary assumption of risk)’ to vitiate delictual liability.

Medical solutions 

McMahon has proposed that on a practical note, putting systems and procedures in place to ensure that patients get the information they are entitled to, will help and that for example, in elective procedures, the preparation of a written explanation sheet (containing information conveyed in lay terminology such as for example, the operation name, the nature of the problem being treated and the proposed treatment, what the operation involves, other treatment options, potential complications, the success/failure rate for the operation, what happens upon admission, how the patient will feel afterwards, how long the patient may be off work, and special post operative precautions, among others) which the patient may be given at the first consultation which they will then have time to re-read and consider before consent is sought, while in such cases consent discussions can take place at a second consultation before admission to the hospital.

In areas of medicine where there are general difficulties in obtaining consent which is truly informed, she cited Prof. in Cardiothoracic Surgery, G.H. Smith who advised for putting in place a system which will reduce the possibility of providing insufficient or poor information, adding that there can be no acceptable alternative to the surgeon who is going to perform the operation to be responsible for obtaining the patient’s understanding and written consent to the proposed operation, and also that if the said surgeon is not the consultant in charge of the patient, then the consultant too must make the opportunity to talk to the patient as well.