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Report No. 196

(3) Ciarlariello vs. Schacter: 1993(2) SCR 119 (La Forest, Sopinka, Cory, McLachlin, Iacobucci JJ)

This is a judgment of the Canadian Supreme Court and deals with the validity of consent given by patients during the course of the treatment.

Mrs. C was diagnosed with a suspected aneurism. Her Neurologist explained through an interpreter both the nature of the angiogram (X-raying of a dye, leading to the brain) and the risks involved. The first procedure was performed by Dr. Mrs Keller, an experienced radiologist. The patient was again explained the procedure through an interpreter. She appeared to understand and gave her consent. Dr. Keller had some misgivings about the patient's complete comprehension. She therefore destroyed the original consent form and insisted that the patient be sent back to her own hospital so that she could talk to her family about her test. She later returned to Dr. Mrs. Keller herself with a consent form signed by her daughter.

The first cerebral angiogram failed to demonstrate a definite aneurism and it was decided that a second was needed. Before that could be done, a 're-bleed' of the aneurism was diagnosed. This increased the risk of morbidity. The patient consented to a second cerebral angiogram. Dr. Greco, also an experienced radiologist, explained the nature of the tests and risks and the patient appeared to understand and consented to the procedure.

During the test, the patient experienced discomfort when hyperventilated and, when she calmed down, she told the doctor to stop the test. The doctors determined that any symptoms she experienced were caused by tetany. The patient, when calm, instructed the doctors to finish the test after they informed her that it would take another five minutes to complete. Dr. Keller, administered the final injection. The patient suffered an immediate reaction to the injection of the dye which rendered her a quadriplegic. Dr. Keller testified that such a reaction was extremely rare and that never before or since, had she seen such a reaction.

The patient brought an action against the respondent physicians. The patient died subsequent to the trial and the appellants carried on the action as her legal representatives. The action and the appeal were dismissed.

The point in issue was the nature and extent of the duty of disclosure owed by a doctor to a patient where the patient withdraws the consent given to a medical procedure during the course of that procedure.

It was held by Cory J, speaking for the Canadian Supreme Court, that there was a sound factual basis for concluding that the patient consented to the continuation of the angiogram and that she was giving consent to continuing the procedure. There was neither fraud nor misinformation in obtaining her consent. The procedure was the one anticipated and was identical to one performed a week earlier.

An objective approach should be taken in deciding whether a risk was material and, therefore, one which should be explained to the patient. The crucial question in determining the issue was whether a reasonable person in the patient's position would want to know of the risk. The doctors involved conducted themselves in an exemplary manner. All the possible risks that could arise from the procedure were fully explained on several occasions to both the patient and her daughter.

Whether or not there has been a withdrawal of consent by a patient is a question of fact. The words used by a patient may be ambiguous. Even if they are apparently clear, the circumstances under which they are spoken may render them ambiguous. On some occasions, the doctors conducting the process may reasonably take the words spoken by the patient to be an expression of pain rather than a withdrawal of consent.

If there is any question of a patient's withdrawal of consent, the doctor must ascertain whether the consent has in fact been withdrawn. Every patient's right to bodily integrity encompasses the right to determine what medical procedure will be accepted and the extent to which they will be accepted. The right to decide what is to be done to one's body includes the right to be free from medical treatment to which the individual does not consent. The requirement that disclosure be made to the patient is based on this concept of individual autonomy.

If during the course of a medical procedure a patient withdraws the consent, then the doctors must halt the process unless the medical evidence suggested that terminating the process would be either life-threatening or pose immediate and serious problems to the health of the patient.

The question as to whether or not a consent given has been withdrawn during the course of a procedure will depend upon the circumstances of each case and may require the trial judge to make difficult findings of fact. Expert medical evidence, while relevant, will not necessarily be determinative of the issue. Indeed, in cases such as these, where the patient must be conscious and cooperative in order for the procedure to be performed, it may well be beyond doubt that the patient was capable of withdrawing consent. The fact that the patient had withdrawn consent at one stage was not in issue here but she later wanted the test to be continued.

The appropriate approach is to focus, in each case, on what the patient would like to know concerning the continuation of the process, once consent has been withdrawn. Looking at it objectively, a patient would want to know whether there had been any significant change in the risks involved or in the need for the continuation of this process which had become apparent during the course of the procedure. In addition, the patient would want to know if there had been a material change in circumstances which could alter the patient's assessment of the costs or benefit of continuing the procedure.

Changes may arise during the course of the procedure which are not at all relevant to the issue of consent. Yet, the crucial question would always be whether the patient would want to have the information pertaining to those changes in order to decide whether to continue treatment. The patient here was capable of giving her consent to the continuation of the procedure based on the earlier disclosures and did so.

The doctor must bear the burden of showing that the patient understood the explanation and instructions, given. The conclusion that the patient here understood and had given valid consent to continue the procedure, notwithstanding the absence of an interpreter, could be drawn from her demonstrated ability to comprehend the language adequately. There was complete and proper disclosure made by the respondents of all the risk involved in the procedure. The appellant's action in negligence must fail.

Cory J, after referring to the principles governing 'liability for battering' and considered the plea of negligence in the light of 'standard of disclosure' expected and the consequences of withdrawal of consent. He quoted Robins JA in Fleming vs. Reid (1991) 4.C.R.(3d)74(CA) and said that the 'right to determine what shall or shall not be done to one's body and to be free from non-consensual medical treatment, is a right deep-rooted in our common law. This right underlines the doctrine of informed consent. The fact that serious risks or consequences may result from a refusal of medical treatment does not vitiate the right of medical self-determination. It is the patient, not the doctor, who ultimately must decide if treatment or any treatment is to be administered.

On facts, it was held that the patient consented to both the angiograms and to the continuation of the second one. There was no fraud in representation. The action must fail.

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