1) The Duty of Care

A physician is under a duty of care both to answer the patient's questions and to volunteer information about the patient's health and treatment options. [Note 21: Some provinces have legislatively codified the obligation to secure an informed consent to medical treatment. See, for example, Health Care Consent Act, 1996, S.O. 1996, c. 2, sch. A, s. 11.] The patient's questions must be answered in a full, frank, and honest manner. There must be no evasion or equivocation. Information must be volunteered in respect of the nature and gravity of the patient's illness, the risks and benefits of the proposed treatment, the risks and benefits of any alternative treatment, the consequences of inaction, any mishaps and accidents occurring in the course of treatment, and the results of the treatment. The extent and detail of the information to be provided is determined on a case-by-case basis by an application of the standard of care.

2) The Standard of Care

The standard of care adopted by the Supreme Court in Reibl is the full disclosure standard. This may be contrasted with the professional standard that measures the defendant's disclosure of information against current professional custom and practice. The professional standard, which is the conventional way to judge the conduct of a physician, was rejected in Reibl on the grounds that it was controlled largely by the medical establishment and it might not protect sufficiently the patient's right to be informed. It should be noted, however, that the term full disclosure is something of a misnomer. It does not require the disclosure of every known risk of the proposed treatment. Sufficient information must be given to allow a reasonable person in the particular circumstances of the patient to make a decision in her best interests. All material risks must be disclosed. A material risk is one to which a reasonable person in the circumstances of the patient would attach some significance in determining the course of her health care. They include low risks of serious consequences and high risks of minor consequences. Special and unusual risks that are not common, ordinary, or everyday occurrences but do occur occasionally must also be disclosed. The courts have not been reluctant to label risks as material. Even extremely low risks of death or paralysis must be disclosed, but remote risks of minor consequences and risks that are common knowledge such as bleeding, scarring, and pain after surgery do not normally need to be discussed.

The standard of disclosure is tailored to the particular circumstances of the patient. The physician must take account of what she knows about the patient and her lifestyle. Account must also be taken of any information supplied by family members. There continues to be some uncertainty over the degree to which a physician must actively inquire about the patient's personal circumstances. This may vary according to the nature of the physician-patient relationship. A long- time family physician or one who has been involved in the treatment of a chronic illness may be expected to have more extensive knowledge than a consultant, a physician working in a walk-in clinic, or a physician in an emergency department of a hospital.

The courts have imposed particularly stringent standards of disclosure in respect of certain kinds of health care. Cosmetic surgery that carries only minor therapeutic benefits and any innovative, experimental, or research procedures necessitate the fullest disclosure of all pertinent information. Any risk to reproductive capacity also demands a full and frank disclosure.

Patients must also be given information about any available alternative treatment. In Haughian v. Paine [Note 22: (1987), 37 D.L.R. (4th) 624 (Sask. C.A.).] a surgeon was held to be negligent for not explaining to the patient that a conservative course of treatment involving medications, rest, and exercise was an alternative to back surgery that carried a risk of paralysis. In Van Mol (Guardian ad litem of) v. Ashmore [Note 23: (1999), 168 D.L.R. (4th) 637 (B.C.C.A.).] the British Columbia Court of Appeal took this obligation one step forward, holding that a surgeon is obliged to discuss any alternative surgical procedures. The patient, who was operated on to relieve a narrowing of her aorta, was not given an opportunity to choose the less risky of three possible procedures and thereby avoid the resulting paraplegia.

The concept of therapeutic privilege was recognized by the Supreme Court in Reibl. It permits a physician to withhold or generalize information relating to the risks of treatment where its disclosure may cause psychological harm to the patient. The privilege has received a narrow interpretation and there is no Canadian case in which it has been applied. In Meyer Estate v. Rogers [Note 24: (1991), 2 O.R. (3d) 356 (Gen. Div.).] the Court refused to apply it where a deliberate decision not to disclose a small risk of paralysis and death arising from an invasive diagnostic test was defended on the ground that the risk of adverse physical consequences was increased by any anxiety suffered by the patient. The trial judge doubted that the privilege was part of Canadian law and stated that, in any event, it could be justified only to avoid psychological harm to the patient, not to minimize physical harm. In these situations, some way, other than keeping the patient in the dark, must be found to allay a patient's fears and anxiety. It is unlikely that other Canadian judges will have greater enthusiasm for the privilege. It has the potential to undermine seriously the patient's right to self-determination and will, therefore, be kept on the tightest of reins.

A patient may waive his right to be informed. He may, for example, make it clear that he has total confidence in the physician and does not wish to talk about risks or dangers associated with the treatment.

Information does not normally have to be repeated throughout the course of treatment or where treatment is temporarily interrupted. In Ciar- lariello v. Schacter [Note 25: [1993] 2 S.C.R. 119.] the Supreme Court considered a case in which the plaintiff patient had undergone two cerebral angiograms to locate a brain hemorrhage. The Court held that the plaintiff was fully informed of all the material risks including the risk of paralysis. During the course of the second procedure, she experienced some discomfort and she withdrew her consent. When she calmed down, she agreed to the completion of the procedure. Shortly after the resumption of the angiogram, she suffered an allergic reaction to the dye and was rendered a quadraplegic. It was argued that a further explanation of the risks was called for before the resumption of the second test. The Court held that this was not necessary. The interruption of the test had introduced no new risks and the risk-benefit ratio of the procedure had not changed. The patient was sufficiently informed to decide whether or not the test should continue.

The physician's obligation under the informed consent doctrine extends only to providing information. The physician is not obliged to advise a patient of what she believes to be the patient's best course of action. That would be inconsistent with the favoured participatory model of the physician-patient relationship which seeks to empower the patient to make her own decisions. This does not, of course, prevent the physician from offering or giving advice in response to a patient's request for it.

The duty to inform patients has been described with reference solely to physicians since they are the primary source of information for most patients. The duty, however, rests on all health care professionals within their area of expertise and practice. This includes not only dentists, physiotherapists, and diagnostic technicians but also those who work on the fringes of conventional medicine such as chiropractors, acupuncturists, and non-traditional healers. Nurses can usually rely on physicians to inform patients but they may have some duty to inform a patient in respect of particular techniques or treatment that are within their sphere of responsibility.

The restructuring of the health-care system and the reduction in the funding of public health care have raised new issues in respect of informed consent. Physicians may now be obliged to inform patients of the inadequacies of the health-care system and of the availability of better diagnostic or treatment options elsewhere in Canada or in the United States. Information may also need to be given in respect of superior medications that may be unavailable to the patient because of their expense.

A further, and largely unexplored, issue is the extent to which a surgeon must disclose her own track record in terms of infection rates, failure rates, any adverse disciplinary or peer review findings, and her health status, such as being HIV positive. In these situations the risks arise not from the proposed treatment but from the professional and personal characteristics of the physician. In Halkyard v. Mathew [Note 26: (1999), 231 A.R. 281 (Q.B.).] it was held that a surgeon did not have to disclose to his patient that he suffered from epilepsy. In that case, however, the epilepsy was well controlled by medications and there was no risk to the patient. More difficult cases will require a delicate balance to be drawn between the physician's interest in privacy and the patient's interest in safety.

3) Causation (Cause-in-Fact)

In order to establish cause-in-fact it must be proved that the patient would not have consented to the procedure if the defendant physician had performed her duty to inform the patient of the material risks of the treatment. If the patient would have made the same decision in any event, causation is not proved. In Reibl, the Court had to choose between a subjective test of causation and an objective one. A subjective test asks what the patient would have done if the appropriate information had been provided. An objective test asks what the reasonable person would have done. Each has its weakness. A subjective test may cause the trier of fact to place too much emphasis on the self-serving testimony of the plaintiff, thereby causing unfairness to the defendant. An objective test risks the conclusion that a reasonable person normally follows her physician's advice, thereby compromising the patient's right to self-determination. In Reibl, the Supreme Court resolved the conundrum by adopting a modified objective test that asks what the reasonable person in the plaintiff's particular circumstances would have done.

There has been some dissatisfaction with the modified objective test. First, there has been no consistent approach as to the range or kind of particular circumstances of the plaintiff that are to be taken into account. This has created some uncertainty and unpredictability in the application of the test. Second, causation has proved to be a substantial obstacle to plaintiffs in informed consent cases. Most informed claims have failed and most have failed on the causation issue.

In 1997 the Supreme Court revisited the causation issue in Arndt v. Smith. [Note 27: [1997] 2 S.C.R. 539.] In that case, the plaintiff contracted chickenpox in the course of her pregnancy. The defendant physician chose not to tell her patient that this posed a small risk of serious birth defects to her child. The child was born with serious disabilities and the plaintiff argued that if she had been told of this risk, she would have terminated her pregnancy. The trial judge applied the modified objective approach, and, after noting that the plaintiff had a particular desire for children and a suspicion of mainstream medicine, he concluded that a reasonable person in her particular circumstances would not have terminated her pregnancy. The British Columbia Court of Appeal ordered a new trial, ruling that the modified objective test had not been applied properly. A majority of the Supreme Court affirmed the modified objective test and held that the trial judge had applied it appropriately. The Court indicated that a wide range of personal factors may be included to modify the reasonable person test. A court may take into account all the objectively ascertainable circumstances of the patient such as her age, income, and marital status, any special considerations affecting the patient, including those that she raised with her physician, and all of the patient's reasonable beliefs, fears, desires, expectations, and concerns. The modified objective test eliminates consideration only of the patient's idiosyncratic, unreasonable, and irrational beliefs and subjective fears that are unrelated to the material risks of the medical treatment. In the opinion of the majority, therefore, it was appropriate to ask what the reasonable pregnant woman who had a particular desire for children, who was sceptical of mainstream medicine, and who had expressed no particular fears of having a disabled child would have done had she been told of the small risk of a birth defect. This is what the trial judge had done and his conclusion that the reasonable woman in these circumstances would not have terminated her pregnancy was upheld.

Although the Court reaffirmed the modified objective test, it has approved the use of so many personal factors that it may not, in practice, be significantly different from the subjective test favoured by the minority of the Court. The decision does, however, present a new challenge. In an ethnically and religiously diverse society, it is difficult to draw a line between beliefs and concerns that are reasonable and those that are not. This difficulty would be avoided and the patient's right to self-determination would be strengthened by a subjective test tempered by a careful judicial assessment of the plaintiff's credibility.

It is difficult to judge whether the informed consent doctrine has influenced or reflected a change in the relationship of physician and patient. The safest conclusion is that the law, medical practice, and changing public attitudes have conspired to transform the relationship into one that is more participatory and egalitarian and more responsive to the patient's right of self-determination.

CHAPTER 3, SPECIAL TOPICS IN NEGLIGENCE