India: Consent and Informed Consent - A Note

Last Updated: 17 September 2002

By S.S.Sagar Priyatham, K.Prathima

Consent to Treatment

The paternalist might argue that there are many examples in medical practice of situations in which treatment is justified in the teeth of the patient’s objection. Arguing from such a position – that the patient may be unable to appreciate that a particular treatment is in his best interest the decision of the doctor to impose the treatment is seen as the patient’s interest inspite of what may turn out to be short-term objections. This, a paternalist would hold, cannot be wrong. Good health and physical comfort are preferable to ill health and physical discomfort and thus a patient will be happier treated than untreated.

From a different perspective, the case for imposed treatment is sometimes couched in social terms. Illness is costly to the community and the individuals are not entitled to refuse treatment that may minimize this cost. If death is to be the consequence of refusal of medical treatment then community may have to bear the cost of supporting the patient’s family. Involuntary treatment is justified in order to avoid this burden.

The Paternalist position is, however, difficult to justify except in the most limited circumstances and these circumstances depend heavily on the existence of ignorance of some sort on the part of the person for whose alleged benefit the action is taken. There will be cases in which intervention by doctors is ethically justifiable but it is difficult to conceive of this being other than when the patient is in an irrational state because of impaired or disturbed consciousness. Restraining a delirious patient is justifiable paternalism, as is the action of clearing the air passages of one who is about to choke to death. The Intervention is justified by the conviction that this is what the patient would need or such treatment is needed to restore him to a position in which he can make up his won mind about further treatment.

The Legal Justification

The common law has long recognized the principle that every person has the right to have his bodily integrity protected against invasion by others. Only in certain narrowly defined circumstances may this integrity be compromised without the individuals consent – as where, for example, a parent or one in loco parents applies justifiable corporal punishment or where physical intrusion involved in the carrying out lawful arrest.

The seriousness with which the law views any invasion of physical integrity finds its basis in the strong moral conviction that everyone has the right of self-determination with regard to his body. Unless there is consent to an act of touching by another, such an act will subject to the principle de minimis non curat lex – constitute a battery for which damages may be awarded. Consent can make physical invasion lawful but the reality of such consent may be closely scrutinized by the law and its, anyway, subject to certain policy limitations; consent will not normally render legitimacy to a serious physical injury.

In medical treatment, every touching of the patient is potentially a battery on that patient. It is the patient’s consent either implied or expressed which makes the touching legally innocuous. The theory then is quite simple but the reality is somewhat different. Over the past decade a considerable volume of litigation in common law countries has focused on the consent issue and as a result the doctrine of informed consent, at it has come to be called has assumed significance in the medical negligence debate.

Is Consent Always Necessary

As a rule, medical treatment even of a minor nature should not proceed unless the doctor has first obtained the patients consent. This consent may be expressed or implied, as it is when patient presents himself to the doctor for examination and acquiesces on the suggested routine. The principle of requiring consent applies in the overwhelming majority of cases, but there are certain circumstances in which a doctor may be entitled to proceed without this consent – firstly, when the patient’s balance of mind is disturbed, secondly, when the patient is incapable of giving consent by reason of unconsciousness; and finally when the patient is minor.

The legal justification of treating a patient without his consent can be based on a variety of grounds. One approach is to argue that the treatment proceeds with consent, although that consent is not expressed. Thus, when as unconscious patient is admitted to hospital, the casualty officer may argue that although the patient was clearly unable to consent to treatment, his consent could be implied or presumed because if he were conscious he would probably consent to the saving of his life in this way. Although this may be true and although the majority of patients could be expected to endorse the decision to treat in such circumstances, it is a rather fictitious way of approaching the problem.

An alternative approach, which has the attraction of greater honesty, is to apply the necessity principle. It is widely recognized in both criminal and civil law that there are certain circumstances in which acting out of necessity legitimates an otherwise wrongful act. The basis of this doctrine is that acting unlawfully is justified if the resulting good effect materially outweighs the consequences of adhering strictly to the law. In the present context, the doctor is justified and should not have criminal or civil liability imposed upon him if the value, which he seeks to protect, is of greater weight than the wrongful act he performs by treating without consent.

A major difficulty with the principle of necessity is its general nature where the court consequently experiences dilemmas in its application. The necessity argument in relation to non-consensual medical treatment would probably be limited at the outset to those cases, which the patient is not known to object to the treatment in question. It could not be applied when the patient is conscious and objects the treatment. Suicide is no longer a crime and although he might be justified on other grounds a doctor cannot not argue that the value he was seeking to protect was the interest, which the community has in preventing the commission of criminal acts. We see this view embodied in the official policy of abstaining from force-feeding of prisoners on hunger strike.

Necessity will be an adequate defence to any proceedings for non-consensual treatment when an unconscious patient is involved and there is no known objection to treatment. The treatment taken, however, must not be more extensive than required by the exigencies of the situation. Therefore, a doctor cannot, take advantage of unconsciousness to perform procedures, which are not essential for the patient’s survival. This principle is laid down in two well-known Canadian cases where the courts explored the distinction between procedures justified by necessity and those, which are merely convenient.

In the first of these Marshal Curry’s decision of the Supreme Court of Nova Scotia, the plaintiff-sought damages for battery against the surgeon who had an operation for a hernia but was removed a testicle. The surgeon’s case was that the removal was essential to a successful operation and that; had he not done so, the health and life of the patient would have been imperiled because the testis

Was itself, diseased. Taking the view that the doctor had acted for the protection of the plaintiff’s health and possibly his life, the court held that the removal of the testicle was necessary and that it would have been unreasonable to put the procedure off until a later date. By contrast in Murry V. Mc.Muchy the plaintiff’s succeeded in an action for battery against a doctor, who had discovered during a Caesarian section that the condition of the plaintiff’s uterus would have made it hazardous for her to go through her pregnancy and although there is no pressing need for the Fallopian tubes to be tied, the doctor went ahead with the procedure. The court in this case took the view that it would not have been unreasonable in the circumstances to postpone the sterilization until after consent had been taken.

The principal that emerges from these two cases is that a doctor is confiding by necessity in proceeding without the patients consent. However, if a condition is discovered in an unconscious patient, whereby, treatment is necessary in the circumstances then it would be reasonable to postpone the operation to a later date. If, however, it is possible to put off any treatment until the patient has been in a position to give consent, the postponement of treatment is to be preferred.

Proceeding Without Consent the Consequences

Non-consensual medical treatment entitles the patient to sue for damages for the battery, which is committed. It is also possible in such circumstances to base a claim on the tort of negligence, the theory that the doctor has been negligent in failing to obtain the consent of the patient. There are certain important differences between the two forms of action and these differences have given rise to much legal debate. In Britain and Canada, however, the issue is now settled and the law is reasonably clear.

An action for battery arises when the plaintiff has been touched in some way by the defendant and when there has been no consent, express or implied to such touching. All that the plaintiff needs to establish is that the defendant wrongfully touched him. It is not necessary to establish lose because of the touching. By contrast, in an action based on the tort of negligence, the plaintiff must establish that the defendant in touching him without consent has led to the injury for which damages are sought. There is thus a problem of factual causation to be tackled and, for this reason; the action for battery is an easier option from the plaintiff’s point of view. The measure of damages recoverable will also be different. All direct damages are recoverable in battery. In an action of negligence, only those damages, which are foresable, may be recovered. Thus, an unforeseen medical complication arising from the procedure may find damages, which are recoverable as battery but not in negligence.

In earlier cases, plaintiffs often brought their action on either count and there was some confusion as to what was the proper basis for particular claims. Clarification has been given of the circumstances to which each action available through the decisions of the Supreme Court of Canada in Reibl V. Hughes and the Appeal court decision in Chatterton v Gerson.

An action for battery is appropriate where there has been no consent at all to the physical contact in question. Thus, an action for battery is the appropriate remedy if a patient refuses to submit to a procedure but the doctor, nevertheless, goes ahead even in the fact of this refusal. A claim based on negligence is appropriate when the plaintiff has given his consent to an act of the general nature, which is performed by the defendant Later, if is found that there is flaw in his consent which means that there is no consent to certain concomitant features if the act. The distinction between the two forms of action was sharply outlined in Reibl V. Hughes by Laskin CJC who remarked in his judgement:

"I do not understand how it can be said that the consent was vitiated by the failure of disclosure of risks so as to make the surgery or other treatment an unprivileged, unconsented to and intentional invasion of the patient’s bodily integrity. I can appreciate the temptation to say that the genuineness of consent to medical treatment depends on proper disclosure of the risks, which it entails. If there has been misrepresentation or fraud to secure consent to the treatment, a failure to disclose the attendant risks, however, serious, should go to negligence rather than battery."

Similarly, it was emphasized in Chatterton v Gerson that an action for trespass to the person is inappropriate once the patient is informed in ‘broad terms’ of the nature of the procedure and thereby, consent is given. An action for negligence is the proper remedy if there is failure to disclose risks. This is in line with the court’s policy of restricting battery actions to acts of unambiguous hostility.

A number of Canadian cases illustrate the sort of circumstances in which an action for battery will be appropriate. Actions for battery were sustained in Mulloy V. Hop Sang, where the plaintiff’s hand was amputated without his consent. In Allan V. New Mount Sinai Capita, where the plaintiff had an anesthetic injured into his left hand inspite of his objection to this procedure and, as a final extraction, in Schweizer V. Cental Hospital, the surgeon performed an operation on the back of plaintiff whose consent was stated to an operation on his toe was held liable for damages for battery. It will be seen that, in all of these cases, what the doctor actually did was quite unconnected with the procedure to which the patient had consented.

The Negligence Action - Causation Problems

The essence of the causation problem in negligence actions is based on a the consent and the court must be satisfied that the defendant’s negligence in failing to obtain the consent of the patient was, in fact, the cause of the patient’s injury. To satisfy this requirement, the patient must prove he would not have given his consent and would not, therefore, have suffered injury that he had the information of which he was allegedly deprived.

The obvious difficulty here is one of discounting the wisdom of hindsight. It will be only too easy for a plaintiff, once he has suffered damage, to allege that he would not have given his consent to the procedure when, in reality, he may well have been quite prepared to do so, even with full knowledge of the risks entailed.

A number of options might be open to the courts. At one extreme is that of giving full weight to the patient’s assertion that he would not have consented had he been aware of all the facts. This entirely subjective approach has the obvious drawback of being weighted overwhelmingly in favour of the plaintiff and is therefore, unacceptable. The opposite approach, which is entirely objective, is to postulate a standard of reasonable patient. Would any reasonable patient give his consent when confronted with full information of the risks and difficulties of the procedure in question? If the answer is yes, then it may be inferred that the plaintiff himself would have consented. This, like all objective tests, has the disadvantage of being potentially unfair to the plaintiff. It may well be that he genuinely would not have consented applying the objective standard might then also be unsatisfactory.

A third possibility exists. The court may opt for an entirely objective approach but qualify it by investing the hypothetical reasonable patient with the relevant special peculiarities of the plaintiff himself. In a way the edge is taken off the objective test while the pitfall of the purely subjective approach are avoided. This compromise is increasingly favoured in the criminal law relating to the plea provocation.

The courts in Canada vacillated between the alternatives of the objective and subjective approaches. Finally, in Reibl V. Hughes (1980) 114 DLR (3d) 1, the Supreme Court came down in favour of an objective test modified by certain subjective factors. The effect of this is that one’s starting point is to determine the extent to which the balance of risks was medically in favour of the treatment in question. This would allow a decision to be made as to whether a reasonable patient would have consented and, that done; the court can proceed to look at the particular patient’s condition. Here the judgment in Reibl V. Hughes suggested that it is important to take into account the patient’s questions to the doctor, as these will demonstrate his concerns and will better enable the court to assess what a reasonable patient in the plaintiff’s position would have done.

Although the matter has not been specifically discussed, the assumption in the most recent English case. Chatterton v. Gorson (1981) 1 All E R 257, would seem to have been that the standard to be applied in England would be a subjective one. This may, indeed be the case in theory but, in practice, the subjective standard is often a thinly disguised objective standard. A court may say that it is attempting to discern the state of mind of the particular plaintiff when in order to reach its conclusions in this regard. It is in fact using the objective tool of judging credibility by asking whether a reasonable person would have taken a similar view. It is, then probable that if the matter arise as a specific issue in a British court the approach followed would be similar to that of the Supreme Court of Canada in Reibl V. Hughes.

Informed Consent - What Needs to be Disclosed?

Most disputes as to consent arise in the context of an alleged non-disclosure of the risks involved in a particular treatment. Looked at from the ethical point of view, the matter is one of self-determination. A person should not be exposed to a risk of damage unless he has agreed to the risk. Although this proposition would probably meet with wide approval, there are differences of opinion as to the event of the duty to disclosed risks. The more paternalistic approach is to countenance the non-disclosure of and considerable amount of information if the doctor thinks it would not be in the patient’s interest. This view accepts that, since the treatment is likely to be to the patient’s benefit, then it is legitimate to withhold, information that would merely serve to distress or confuse the patient. It should be noted that this is not the same thing as deciding to with hold information, which it is thought, would lead the patient to confuse the treatment. The latter practice is hardly acceptable ethically.

An alternative school of thought holds that, given a rational patient, the doctor must reveal all the relevant facts as to what he stands to do. It is not for him to determine what the patient should or should not hear. Obviously there must be some medical assessment of what is or is not significant but, apart from the exclusion of irrelevant material, the patient should be as fully informed as possible so that he can make up his mind in the light of all the material circumstances.

This second approach fully satisfies the requirements of self-determination but can be criticized because it leaves little scope for the exercise of clinical judgment by the doctor. Is there any point in burdening a patient with knowledge of risks when the doctor in charge of the case know, or at least strongly suspects, that this will give to retard recovery? It seems particularly pointless when there is, any event, a shrewd understanding on the doctor’s part of what the patient’s eventual decision will be. Reassurance of the patient may be in essential part of the programme of treatment and any dwelling on or even mention of risks may well harm the patient’s health.

The choice between a patient standard and a professional standard is a difficult one. There must be respect for the patient’s legitimate interest in knowing to what he is subjecting him, but at the same time, there will clearly be cases where a paternal approach is more appropriate. In addition, the practicalities of the situation must be borne in mind. Although it might be ethically desirable for patients to be as fully informed as possible, the time spent in explaining the intricacies of procedures could be considerable, particularly if a doctor is expected to deal with remote risks. Doctors simply do not have the time to waste on unduly lengthy explanation of all the ramifications of treatment. A compromise must be to place on the doctor the duty to inform of the risks of a procedure as far as there is material showing that there is no pressing clinical reasons to protect the patient from a knowledge of such risks.

The courts have been of some assistance in assessing what risks are materials. These have been defined as those risks which are reasonably and which must be considered serious in their effect. A very remote risk need not be disclosed unless it is a risk of a very serious consequence. Risks, which are attendant upon medical procedures as a whole, need not be disclosed and explained, but the requirement applies only to those, which are specific to the procedures in question.

Cases

Whatever standpoint one takes on this matter, a decision of some court can be found to endorse on preferred approach. In the United States, for example, there are some jurisdictions in which the full disclosure rule applies and others in which the professional standard bas been accepted. Within the commonwealth, there are decisions ranging from the endorsement of the deliberate medical be to the acceptance of the extreme patient-orientated approach which emphasizes complete disclosure of risk. The diversity of opinion is equally evident in academic discussion; some writers have thought to give the informed consent doctrine extensive scope while others have urged caution in the face of what has been seen as an indirect and inappropriate means of widening the potential liability of doctors.

Because of the varied fate of the consent issue in the United States, we propose not to deal with the American experience in this area other than to draw from it a salutary lesson of conclusion that can result from uncoordinated judicial developments of the law. Within the Commonwealth, although there has by no means been unanimity as to the ways in which the courts should deal with the question of consent, the law appears to be fairer and rather more consistent.

The three most significant cases for British courts are Bolam V. Friern Hospital Management Committee (1957) 2 AII E R 118, Smith V. Auckland Hospital Board (1964) NZ LR 241 SC revsd. (1965) NZ CA and Chatterton V. Gerson (1981) I All ER 257. The first of these decisions, Bolam, concerned the administration of electro convulsive therapy – without explanation of the risks in the light of the patient’s condition. As the judge said in his charge to the jury.

"Your may well think that when a doctor is dealing with mentally sick man and has a strong belief that his only hope of cure is submission to elector-conclusive therapy, the doctor cannot be criticized if he does not stress the danger, which he believed to be minimal, which are involved in their treatment."

Thus note of caution has been sounded in a number of other cases. In the Canadian case of Kenny V. Lockwood (1932) IDLR 507, for example, the court held that the duty placed upon the surgeon of dealing honestly with his patient does not extend to a duty to inform the patient of details which were calculated to frighten or distress him.

Smith V. Auckland Hospital Board has been a unique case. Here the patient alleged that he did not give his informed consent to the performance of an aortogram in that he was not told of the risks it involved. In a dictum which has since been readily referred to, the judge outlined what should be taken in to account in deciding what the patient should be told:

"As it seems to me the paramount consideration is the welfare of the patient and given good faith on the part of the doctor, I think the exercise of his discretion in the area of advice must depend upon the patient’s overall needs. To be taken into account should be the condition to the treated, the importance of the benefits to be expected to flow from the treatment or procedure, the need to encourage him to accept it, the relevant significance of its inherent risks, the intellectual and emotional to prevent any decision at all, and the extent to which the patient may seem to have placed himself in his doctor’s hands with the invitation that the latter accept on his behalf the responsibility for intricate or technical decisions."

This firm endorsement of the professional standard if disclosure was followed by a rejection of the proposition that there should be an automatic need to describe all possible risks involved in a procedure. This would distract doctors from their prime responsibility of caring for the health of their patients. This difficulty of determining just what risks should be disclosed has been grappled with by the courts in several cases. Canadian decisions are useful here. In Hopp v.Lepp (1980) 122 DLR (3d) 67, the plaintiff had suffered injury as a result of a back operation. This case had certain special features, which rather strained the consent doctrine. The patient alleged that the doctor should have told him that this was the first time he would perform the operation since obtaining his specialist certificate, an argument which the court, not surprisingly, rejected. Apart from dealing with this rather tenuous argument, however, the court also emphasized that the doctor needs to disclose only probable or unusual risks. A doctor need not go into every conceivable detail of a proposed operation provided he describes its general nature and particularly answers any question which the patient puts to him.

The evidence of expert medical witnesses is established practice in relation to disclosure plays an important part in deciding whether there has been a failure to inform adequately. The significance of this is that reliance on such evidence inevitably weights the matter in favor of the medical defendant and, thereby, this contradicts the principle of self-determination by the patient. British courts are clearly in favor of the experts witness approach. As can be seen in the judgment in Chatterton v.Gerson (1981) I ALLE 257. There has been a move in the other direction in Canada, with greater weight being given to the role of the court as the trier of fact in assessing what it was that the patient wanted to know or, indeed to know. This was the approach adopted in Reibl v.Huqhes (1980) 114 DLR (3d I). And followed in White v.Turneer (1981) 120 DLR (3d) 269. In White, the patient had been submitted to breast reduction surgery, which left her with large scars, the possibility of which has not been adequately explained. The court held that there had been negligence and tooled the opportunity to observe that the upshot supreme court’s decision in Reibl was that, no longer does the medical profession alone collectively determines, by its own practices. The amount of information a patient should have in order to decide whether to undergo an operation shall be given due weight age.

This should not to be taken to mean that doctors should give complicated medical seminars on medicine to all their patients. It did means, that patients should be treated as intelligent and rational, to whom matters should be explained in some detail. This, the court felt, perhaps rather optimistically, would lead to the emergence of medical practitioners who are more sensitive, concerned and human than they are now.

The Consent Doctrine in the Future

North American writers have described the progress of the consent doctrine as a tempest. Certainly, the history of its development in the United States has shown remarkable inconsistency, leading in many cases to absurdities and encouraging malpractice, litigation unduly. It has undoubtedly resulted in greater sensitivity on the implications of treatment but this positive result has only been achieved at the price of heightened distrust and an increase in the practice of legalistic and defensive medicine.

It is unlikely that the consent doctrine will be as widely used In British courts as it has been in the United States. The lines have now been clearly drawn on the issue of the battery-negligence distinction and that undoubtedly restricts the scope of consent actions. In addition, reliance on expert evidence is likely to continue which means that the movement towards the patient-oriented approach, which is evident in the recent Canadian decisions, is unlikely to occur.

The consent should interpret the consent issue in the context of medical liability. British courts are clearly cautious, even if not all judges are as favorable to doctors as was Lord Denning. Actions based on lack of consent are generally seen by lawyers, as final attempt to obtain damages when more obvious medical negligence is evident. It this light, consent actions may well be regarded as back door attempts to extend the scope of medical liability and may, therefore, expect to encounter both judicial skepticism and powerfully voiced policy objections.

The content of this article is intended as a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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