Medicine and the Law - Informed Consent in Medical Cases

With medical negligence suits on the rise, the notion of ‘informed consent’ becomes increasingly important in the medico-legal vocabulary. Dr Myint Soe traces the development of the different standards of informed consent, looks at the local situation and calls for greater clarity and guidelines in the medical profession in Singapore.

Doctors and dentists are being increasingly sued for negligence. Among the charges made against them are that they were negligent in not ‘informing’ the patient (or the relatives) of the consequences of treatment and/or the alternatives available to them in obtaining their consent.

The emphasis is therefore on ‘failure to inform’ rather than the obtaining of consent. In most cases, ‘consent’ would have been given or formally taken in a letter of consent.

The present Singapore practice, as practised by many doctors and dentists, almost verges on medical paternalism and, as the saying goes, ‘doctor knows best’. Thus, one gets flabbergasted when one hears from a general practitioner that no warning was given in the administration of a tetanus shot, as nothing usually happens (which is true); or when a dentist extracts a wisdom tooth and nothing is said as to the possible consequences, as after all, the tooth should come out without much fuss (which is also true). Things have, however, improved in recent years and the term ‘informed consent’ is reaching the ears of many practitioners.

The Hippocratic Oath (400BC) says nothing about information or disclosure by the physician and, understandably, adopts the maxim ‘doctor knows best’. The cynic may well say that as the doctor himself did not know much at that time, there is hardly anything worthwhile to inform or disclose to the patient (who would not understand in any case). However, by the 19th Century, when the Penal Code was drafted and enacted, the necessity of obtaining a patient’s consent was well understood (sections 88 to 93) in civilised societies. Indeed, the Penal Code (section 93) recognises that a patient has a right to know, even if the communication might cause his death by shock.

As far as most doctors and lawyers in Singapore are concerned, if they are asked about what the law on informed consent in Singapore is today, the rough answer (and quite correctly) would be that it is encapsulated in the Bolam test, after the landmark decision in Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. English medical negligence decisions would come under that part of English common law which was part of the law of Singapore immediately before 12 November 1993, within the meaning of section 3 of the Application of English Law Act 1993 (Cap 7A). Thus, the test would be whether the doctor concerned has acted in accordance with a practice accepted as proper by a body of responsible and skilled medical opinion, even though there may be another body of such medical opinion which disagrees. Thus, the test of negligence for doctors and dentists is ‘the medical test’. This Bolam test covers two areas:

The Bolam test has increasingly come under attack, especially from the United States, Canada and Australia, and while some are still prepared to leave the question of ‘diagnosis and treatment’ to doctors and dentists, it is felt that the question of the sufficiency of information, disclosure and warnings given (ie informed consent) should be left to the judge (or jury).

Informed consent is an American doctrine, and the classic statement of it would be found in the above case decided by the US Court of Appeals, District of Columbia, in 1972. In that case, Mr Canterbury (aged 19) and his mother were told by the surgeon that in carrying out laminectomy (dealing with a ruptured disc), there was the risk of paralysis. The Court of Appeals rejected the medical test in Bolam’s case and stressed the patient’s right of self-decision. Therefore, all the information material to the decision must be given. It is to be noted that the US court adopted an objective test based on trespass to the person and not on negligence.

It is also to be noted that the Canterbury doctrine of informed consent has been rejected by a majority of American states, including the Supreme Court of Virginia in Bly v Rhoads (1976) 222 SE (2d) 783.

The Supreme Court of Canada followed Canterbury v Spence (supra). The surgeon in this case was proposing surgery involving a neck artery, for a patient suffering from chronic headaches. The patient was not told that the surgery would not clear the headaches and there was a 4% risk of death and 10% risk of a massive stroke (which the patient ultimately suffered). Thus, it was held that doctors had an undoubted duty to disclose ‘all material risks’ and it was for the court to decide what was material. However, the court recognised that failure to inform was not enough and that there was still the question of ‘causation’, applying the ‘reasonable man’ test. It is also important to note that this Canadian case merged the duty to inform into the general duty of care. Thus, unlike, Canterbury’s case, liability was based on negligence and not on trespass to the person.

Sidaway v Board of Governors of Bethlem Royal Hospital [1985] AC 871 — England

This English House of Lords decision basically confirmed the Bolam test by a majority of 4 to 1, Lord Scarman dissenting. Lord Scarman’s judgment is better known as it preferred the American doctrine of informed consent, although even he, in the end, decided on the facts that the patient had not proved that the surgeon had failed to warn. As the Bolam case and the Sidaway case would still be Singapore law, it is important to study the four judgments upholding the medical test. Lord Diplock pointed out that the Canadian effort to transfer the concept of informed consent to negligence and not battery (or trespass to the person), ‘simply cannot be made to fit’, and there is no room in the concept of informed consent for the ‘objective’ patient.

In Sidaway’s case, Mrs Sidaway (71 years old) brought an action against her surgeon for performing a laminectomy and foraminectomy. The operation was unsuccessful and she became partially paralysed. Her only complaint was on informed consent. She complained that if she had been told of the risk of catastrophic failure, she would not have given her consent. All information necessary for her to make an informed decision should have been given. Unfortunately, the surgeon had died before the case came for trial, and it was a bad test case. The House of Lords, by a majority of 4 to 1, applied the Bolam test and held that the information to be given would depend on what an informed and responsible body of medical opinion would have thought was proper for the patient to know.

There have been important English decisions after Sidaway’s case where there have been some indication that the Bolam test may have to be reconsidered. One recent case is that of Bolitho v City and Hackney Health Authority [1997] 3 WLR 1151, also a House of Lords decision. It was made clear by the House of Lords that the Bolam test may not be used in deciding every issue in a case involving medical negligence. It was pointed out that in the generality of cases, the Bolam test had no application in deciding questions of causation. Nonetheless, on the facts, the Bolam test was still applied. It is also interesting to note that among the five law lords who sat in Bolitho’s case, there was none who sat in Sidaway’s case 12 years ago. Lastly, in dealing with English cases, one might mention the recent case of Penney & Anor v East Kent Health Authority [2000] Lloyd’s Rep Med 41. In that case, the Court of Appeal accepted that two sets of competent experts may genuinely hold different opinions. In such a case, the Bolam test would have no application, if what the judge is required to do is to make findings on facts.

Rogers v Whitaker (1992) to Naxakis v Western General Hospital (1999) — Australia

Australian courts had been reluctant to apply the Bolam test and this was highlighted by the Australian High Court in the landmark decision of Rogers v Whitaker (1992) 175 CLR 479. In this case, the patient had lost sight of her right eye as a child. In 1983, she underwent an eye-operation (for the only eye left) by Dr Rogers and developed a condition known as ‘sympathetic opthalmia’, a rare complication with a chance of approximately 1 in 14,000. She sued for failure to warn of this risk. The High Court held that a medical practitioner had a duty to warn of material risks, ie a risk which a reasonable person would likely attach significance to, or the practitioner is reasonably aware that the particular patient would be likely to attach significance to it. Both the Bolam test and Sidaway’s case were rejected. The US case of Canterbury v Spence and the Canadian case of Reibl v Hughes were followed instead.

While Rogers v Whitaker sounded the death knoll of the Bolam test in Australia, the recent case of Naxakis v Western General Hospital (1999) 73 ALJR 782, also decided by the Australian High Court, has buried it. In that case, Paraskevas Naxakis (a boy) was hit in the head by a schoolmate’s school bag. He came to the casualty section of the hospital on being referred by a general practitioner. He was treated by a senior neurosurgeon and after staying about ten days in the children’s ward, was fit enough to be discharged. Two days later, he collapsed at home and was admitted to another hospital. An angiogram showed he had a burst aneurysm and suffered serious and permanent physical and intellectual impairment. Both the trial court (Supreme Court of Victoria) and the Court of Appeal felt the neurosurgeon could not be negligent and dismissed the claim. The High Court allowed the appeal. Their Honours in the High Court were anxious to see that the Bolam test which had been rejected in Roger’s case, was not re-introduced. They reiterated that a finding of medical negligence may be made even though the conduct of the defendant (doctor) was in accord with a practice accepted at the time as proper by a responsible body of medical opinion. While it is true that the Naxakis case deals with diagnosis and treatment, it supports the view that the Bolam test has also been rejected with regard to the doctor’s duty to warn (ie inform and/or disclose).

Fortunately for the doctors and dentists in Singapore, the common law of England as applied in Singapore on 12 November 1993 is still the relevant law. See the remarks of Amarjeet JC in Pang Koi Fa v Lim Djoe Phing [1993] 3 SLR 317. The Bolam test still holds as long as it and Sidaway’s case (House of Lords) is not overruled in England, or disapproved by the Singapore Court of Appeal. The recent English case of Penney (supra) is only a Court of Appeal case. Bolitho’s case still applied Bolam’s case. The views of medical experts which will constitute a body of medical opinion would still be relevant. In any case, even if there is a failure to warn (inform and/or disclose), there is still the question of causation. Applying the objective test, the question which still remains is whether a reasonable man in the shoes of the patient would have refused the operation or treatment had he been fully informed of the risks.

However, Singapore doctors and dentists must realise that the writing is now on the wall. It is a matter of time before the developments in the United States, Australia and Canada are considered. Even in Malaysia, a High Court judge has approved the formulation in Roger’s case in Kamalam v Eastern Plantation Agency [1996] 4 MLJ 674. In Hong Chuan Lay v Dr Eddie Soo Fook Mun (1998) 5 CLJ 251, another judge has agreed that for information and advice, it should not be a medical judgment and should be for a court to decide. There is really no harm in informing patients of material risks. Perhaps, the Singapore Medical Council which oversees the medical profession would consider the inclusion of some guidelines in the Ethical Code published by it, with regard to ‘informed consent’ or the doctor’s ‘duty to warn’ (inform and/or disclose). Significantly, in the present edition of the Code published in 1995, the ‘informed consent’ of the patient is only specifically required in experimenting or authorising experiments or research causing undue suffering or threat to the life of the patient; unfortunately, there is no indication as to the extent and scope of the ‘informed consent’ required.