The Pediatric Cardiac Inquest Report - Chapter 1



The law of medical consent

The law of medical consent has been undergoing changes in recent years. The abiding principle for consent was always that the consent had to be an informed one. Patients were to be told whatever needed to be known about a particular procedure in order that their consent could be valid.

For the most part, the question of what information was to be given to patients in order that they be in a position to give informed consent was governed by the practice of the medical profession. Medical practitioners were generally held to have fulfilled their legal obligation if they provided information to a patient in accordance with the practice among their colleagues.

However, recent case law in Canada, Australia, and the United States suggests that that principle is changing.

Generally, it is the patient, not the surgeon, who decides whether or not surgery will be performed, where it will be performed and by whom it will be performed (Allan v. New Mount Sinai Hospital (1980), 109 D.L.R. (3d) 634 at 642, rev'd on a procedural point 125 D.L.R. (3d) 276 (Ont. C.A.)).

Furthermore, a doctor's duty to inform relates to all material risks, including special and unusual risks of treatment. What is material is determined by what the reasonable patient would want to know, and not by what the reasonable doctor would like to disclose (Hopp v. Lepp [1980] S.C.R. 192 (S.C.C.) at 204).

Material risks are those risks that pose a real threat to the patient's life, health or comfort (White v. Turner (1981), 120 D.L.R. (3d) 269 at 284 (Ont. H.C.), aff'd (1982), 12 D.L.R. (4th) 319 (Ont. C.A.)).

A failure on the part of the doctor to fully inform the patient will generally be dealt with by negligence law, and not by battery (unless there has been misrepresentation or fraud to secure consent). In other words, a lack of properly informed consent does not give rise to an action for the improper application of force (Reibl v. Hughes [1980] 2 S.C.R. 880 (S.C.C.), at 891-892).

The fact that a patient has signed a consent form in which it is acknowledged that the nature of the operation has been explained does not necessarily prove that the duty to inform has been observed. The existence of the consent form does not protect the doctor from liability unless the patient has been informed to the satisfaction of the court (Bickford v. Stiles (1981), 128 D.L.R. (3d) 515 at 520 (NBQB)).

In an Ontario case, a surgeon who had failed to disclose to his patient that he had little experience with the technique being used was found to be negligent in the performance of the operation. However, on the question of the consent of the patient to the operation, the trial judge held that the surgeon failed in his duty to his patient by failing to disclose his inexperience and failing to give his patient the opportunity to have the procedure performed by another more experienced surgeon (Miles v. Judges (1997) 37 C.C.L.T. (2d) 160 (Ont. Ct. Gen Div.)).

In the case of Hopp v. Lepp (supra, at 197), the surgeon had told the patient that the facilities for performing the operation were as good in Lethbridge as they were in Calgary where the patient had thought of going. Laskin C.J. approved of the trial judge's finding that the operation was a routine one, and that although there was a possibility of complications as there is in any operation, there was no greater probability of complications of the operation being performed at Lethbridge as opposed to Calgary. In other words, there was no evidence that the assurance given by the surgeon was incorrect or that if the operation had been done in Calgary it might have produced a different result.

Every medical practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care (Crits v. Sylvester [1956] O.R. 132 (Ont. C.A.) at 143-144, aff'd [1956] S.C.R. 991). In the same vein, all those involved in the care of the patient, including the referring physician, nurses, anaesthetists and medical managers all owe such an obligation to the patient.

Whether a risk is material and whether there has been a breach of the duty of disclosure are matters that are not determined solely by the professional standards of the medical profession at the time. Professional standards are a factor to be considered, but the ultimate responsibility in determining if the professional met the appropriate standard lies with the court (Videto et al. v. Kennedy (1981), 33 OR (2d) 497 (Ont. C.A.)).

It is generally accepted in England that doctors have a duty to exercise reasonable care with their patients. This duty extends not only to examination, diagnosis and treatment, but also to the provision of appropriate information. In determining whether a medical practitioner has breached his or her duty of care to a patient, the courts of England had generally applied the Bolam principle, by which a doctor would not be found to be negligent if he or she acted in accordance with the practice accepted at the time as proper by a responsible body of medical opinion (Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582). This was so even though other doctors might have followed a different practice. The basis of the principle is that it leaves room for differences of opinion in matters involving medical expertise. A medical practitioner would not be held negligent simply because his or her conclusion or approach differs from that of other practitioners.

Whether the Bolam principle applies in providing information and advice relevant to medical treatment was reconsidered by the British House of Lords in 1985 (Sidaway v. Governors of Bethlem Royal Hospital [1985] 1 AC 871).

In that case, the plaintiff alleged that the defendant surgeon failed to explain the risks of permanent damage to the spinal column (assessed at between one and two per cent), involved in an operation on the spine to relieve neck, shoulder and arm pain. The majority of the House of Lords held that the question of whether a failure to warn a patient of the risks inherent in proposed treatment constituted a breach of a doctor's duty of care was to be determined by applying the Bolam principle. Thus the issue was determined primarily on the basis of expert medical evidence, although a majority of the Law Lords took the view that doctors were under a duty to provide a patient with sufficient information.

In his dissenting opinion in Sidaway, Lord Scarman expressly rejected the Bolam principle in relation to cases involving advice or information. He concluded that while current medical opinion was a relevant consideration, it was not conclusive and it was for the court to decide whether the doctor had given the patient the relevant information to enable the patient to determine whether or not to accept the treatment proposed.

In 1998 the England and Wales Court of Appeal considered and accepted the Sidaway decision (Pearce v. United Bristol Healthcare NHS Trust [1998] EWJ No. 617), but added that a doctor must inform the patient of significant risks:

In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law, as indicated in the cases to which I have just referred, that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt. (Ibid, at para. 18)

Further, with regard to whether a risk is material and how this is to be determined, the Court stated:

I am of opinion that the judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it. The kind of case I have in mind would be an operation involving a substantial risk of grave adverse consequences, as, for example, the ten per cent risk of a stroke from the operation which was the subject of the Canadian case of Reibl v Hughes. In such a case, in the absence of some cogent clinical reason why the patient should not be informed, a doctor, recognising and respecting his patient's right of decision, could hardly fail to appreciate the necessity for an appropriate warning. (Ibid, at para. 19)

This decision and the judgment of Lord Scarman in Sidaway are based on principles that were enunciated in a leading U.S. case (Canterbury v. Spence [1972] 463 F. 2d 772, U.S. Court of Appeals, District of Columbia Circuit). The U.S. Court of Appeals for the District of Columbia held that a doctor was under a duty to disclose all 'material' risks. A risk was to be considered material if a reasonable person, in what the doctor knew, or ought to know, was the patient's position, would be likely to attach significance to the information in determining whether to forgo or proceed with the proposed treatment.

As well, the U.S. case of Johnson v. Kokemoor held that a jury properly heard evidence on the extent of a surgeon's experience in performing a complicated procedure, as well as evidence that compared morbidity and mortality rates between experienced and inexperienced surgeons, and evidence that the plaintiff could have obtained care nearby from more experienced surgeons. The jury concluded that the surgeon had not adequately informed the patient of the risks attending her surgery, including apparently, the risk associated with the level of the surgeon's experience. In this case, the patient posed very specific questions to the surgeon before surgery, questions that the surgeon did not answer fully or accurately (Johnson v. Kokemoor Westlaw No. 93-3099, Supreme Court of Wisconsin (20 March 1996)).

The U.S. case of Canterbury v. Spence was cited with approval by the Supreme Court of Canada in Reibl v. Hughes, in which it was held that the medical practitioner's 'duty to warn' arises from the patient's right to know of material risks, a right that in turn arises from the patient's right to decide for himself or herself whether or not to submit to the proposed medical treatment. The court accepted that expert medical evidence is relevant to a finding as to the risks that reside with recommended surgery or other treatment, and may have a bearing on the question of the materiality of the risk. But it concluded that the question of what risks are to be disclosed is not a question to be concluded on the basis of expert medical evidence alone. Account will be taken of a patient's particular position as well.

In Australia it is generally accepted that the standard of care of doctors is not determined solely by reference to a responsible body of opinion in the relevant trade or profession. In both Rogers v. Whitaker (Rogers v. Whitaker (1992) 175 CLR 479) and Chappel v. Hart (Chappel v. Hart (1998) HCA 55), the Bolam principle was rejected, and it was accepted that, while evidence of medical practice was a useful guide, in the end it was for the courts to decide the appropriate standard of care in the circumstances.

In Chappel v. Hart, Chappel, an ear, nose and throat specialist, performed surgery on a patient, Hart, for the removal of a pharyngeal pouch in her esophagus. Hart would have required the operation eventually but it was still considered elective because she did not need it right away. Hart had expressed concern on what effect the operation might have on her voice. Chappel failed to warn her of a small risk of vocal damage if the esophagus were perforated and an infection set in. During surgery, Hart's esophagus was perforated and infection did set in, which led to a paralysis of the right vocal cord. The failure of Chappel to warn Hart of the risk of damage to her voice was held to have set off a foreseeable chain of events permanently affecting Hart's voice.

While Hart admitted that she still would have undergone the operation even if she had been warned of the risk, she testified that she would have deferred the operation, taken further advice and probably would have sought out the most qualified surgeon available. That surgeon was apparently not Chappel.

There was a difference of opinion between the majority and dissenting judges as to whether surgery by a more experienced surgeon would have carried a lower risk to the patient's voice. The majority of the judges concluded that the risk would have been lower had a more experienced surgeon performed the operation.

More importantly, three of the five judges held that Chappel's failure to advise Hart of the risk led to her undergoing the procedure when and where she did, and vitiated her consent.

The Court therefore clearly held that a medical practitioner is under a duty to inform a patient of any foreseeable risk. It also went further, however, and held that where such a duty arises, it is necessary for the plaintiff to establish what she would have done if the information in question had been provided to her (Ibid, at para. 9).

The court in Chappel adopted a primarily subjective theory of causation in determining whether the failure to warn would have avoided the injury suffered.

Gaudron J. seemed most influenced by the evidence of a medical professor that suggested that the risk would have been less if Hart had had a more experienced surgeon. He stated:

It is not in doubt that a risk of perforation and infection was and is inherent in surgery of the kind performed on Mrs. Hart. In that sense, the risk of injury was the same, no matter when or by whom the surgery was performed. However, that is not to say that the likelihood of that risk eventuating was the same.

Professor Benjamin gave evidence from which it might be inferred that the risk of perforation, without which the injury sustained by Mrs Hart could not have occurred, diminished with the skill and experience of the surgeon concerned. (Ibid at para 17)

Similarly, Gummow J. found that Hart would not have undergone the procedure by Chappel, but would have wanted "the most experienced person with a record and reputation in the field, such as Professor Benjamin" (Ibid, at para. 78). Kirby J. held that "intuition and common sense suggest that the higher the skill of the surgeon, the less is the risk of any perforation of the oesophagus into the mediastinum" (Ibid, at para. 97).

Kirby J. also placed considerable significance on the fact that Hart had inquired into a possible risk to her voice. He said, "(t)his was not an ordinary patient. It was an inquisitive, persistent and anxious one who was found to have asked a particular question to which she received no proper answer" (Ibid, at para. 99).

In another very recent Australian case, the Court felt that the trial judge erred in failing to take into account the circumstances of the patient in deciding whether she would have undergone the procedure had she been properly informed. (Percival v Rosenberg [1999] WASCA 31 (25 May 1999)). It stated:

Applying the law as discussed in Chappel and Rogers v Whitaker, the learned trial Judge erred in finding that the respondent was not required to warn the appellant of the risks of TM joint problems and symptoms arising after the procedures which the appellant underwent.

The learned trial Judge rejected the proposition that the appellant would have not had the surgery had she been warned of the possible risks. However, in my view the submission of the appellant's counsel that in coming to an adverse view of the appellant's credibility the learned trial Judge did not take into account the important matter of the severe effects which the complications have had upon the appellant, both physically and mentally, is correct. His Honour did not discuss the ramifications of those matters. (Ibid, at paras. 99-100)

Thus the Court agreed that a more subjective approach should be taken when assessing whether a patient would have agreed to the operation.

Rogers v. Whitaker was another case that concerned the obligation of a doctor to advise on material risks. The issue was whether a surgeon should have warned the patient, in advance of an eye operation, of a particular complication shown to occur in one out of 14,000 such operations. Despite the patient expressing her concerns about the operation, the doctor had given her no warning of the risk and the operation proceeded. The patient did develop the complication following surgery, and it led to blindness. The doctor led evidence from a body of medical practitioners that they would not have given such a warning. Then, invoking the protection of Bolam, the doctor contended that he was therefore not negligent.

The High Court disagreed and held that he was negligent because he knew that if he had warned the patient about this risk, she would have regarded it as significant. The Court formulated the duty as follows:

The law should recognize that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. (Ibid, at p. 490)

The Chappel decision supported the view that this test was the correct one to apply for determining issues of informed consent. This test is very similar to the test in Canada and seems to be the direction in which the English courts are also heading.

Most of the case law concerning medical consent arises in the field of tort law-that is, the law concerning claims for damages as a result of an improper act or omission. The cases centre on two questions: firstly, whether any consent to treatment was properly obtained; and secondly, if not, whether the lack of consent (or, perhaps more properly, the lack of information that voids consent) directly led to the damage or injury claimed.

The latter issue is not one about which I need be concerned, because of its fundamental attachment to the question of culpability.

Medical case law has made allowances for the fact that where a doctor's decision to treat a patient in a certain manner was reasonable, taking into account the risks involved and based on accepted medical practice, it was logical to conclude that a reasonable person, having been properly informed of the risks, would not have declined the treatment. In other words, a court would not inquire into the question of whether the information not disclosed to the patient would have resulted in the patient doing something different from what was done. The court went only so far as to determine, using the standards of the profession, whether a person acting in a reasonable manner would have declined the operation.

That principle has changed somewhat recently, however. Currently, the approach in failure to inform cases in Canada has moved to using a modified objective test that allows the court to consider the patient's personal circumstances (Reibl v. Hughes, infra).

The test now is to determine the matter from the perspective of whether a reasonable person in the circumstances of the plaintiff would have consented to the proposed treatment if all the risks had been disclosed.

In 1997, the Supreme Court had occasion to consider the issue once again. A pregnant woman suffered from chicken pox early in her pregnancy. The case centered on the duty of her doctor to disclose to her that the chicken pox entailed risks of serious birth defects for her unborn child. He made no such disclosure to her. The mother sued the doctor for damages after her child was born with serious disabilities as a result of the chicken pox. The mother testified that she would have terminated the pregnancy had she been advised of the risks. The trial judge found that a reasonable woman in the plaintiff's position would not have done that, but would have continued with the pregnancy despite the risks. In other words, her evidence as to what she would have done was not determinative of the matter. A majority of judges in the Supreme Court of Canada agreed with the trial judge and with the test used for causation (Arndt v. Smith [1997] 2 SCR 539).

McLachlin J. (as she then was) delivered a separate decision in which she also agreed with the ultimate decision of the trial judge, but enunciated the test for causation to be one that asked what the particular plaintiff would have done in all the circumstances. She also accepted the trial judge's view that the reasonableness of the patient's choice is an important factor bearing on that decision. Both Sopinka J. and Iacobucci J. dissented. They agreed with the test of causation proposed by McLachlin J., but took the view that the trial judge had not applied that test properly by discounting the plaintiff's testimony.

A summary of the applicable legal principles dealing with medical consent

From all of this it is possible to discern the following principles:

  • It is the patient who decides whether, when, where and by whom surgery is to be performed.

  • For a consent to medical treatment to be valid, it must be informed consent.

  • What a patient is told is not to be determined solely by what the practice of the profession is, although knowing that practice can assist the court.

  • A doctor must inform a patient of all material risks. What is material is determined by asking the question "what would a reasonable patient want to know?"

  • Material risks are also those risks that pose a real threat to the patient's life, health, or comfort.

  • A failure by a doctor to fully inform a patient is a matter for the law of negligence.

  • The fact that a patient has signed a consent form does not determine the issue. It is for the court to determine if the facts show a fully informed consent.

  • A surgeon's inexperience can be a factor affecting risk that a doctor must disclose to a patient.

  • In Canada, in determining if the patient's consent to a procedure has been fully informed, the court must consider the question of whether all material facts have been disclosed, and if not, whether a reasonable person in the same position as the patient would have gone ahead with the procedure in any event.

In an article by the Hon. Paul de Jersey prepared for the Medico Legal Society of Australia, the question of medical consent was discussed (March 22, 1999. Found at De Jersey points out that there is a change occurring through society in how people view their health, and in what they feel they are entitled to know. There is a movement away from the paternalistic 'doctor knows best' standard to one that involves the patient more, especially when it comes to surgical procedures. De Jersey points out that doctors have not always provided their patients with the information that patients felt they needed or were entitled to, for a variety of reasons. Perhaps, he suggests, that failure stemmed from a desire to protect the patient from anxiety or because it was too time-consuming and difficult. If so, that approach was going to have to change. The case law discussed above seems to support the conclusion that that approach is being reflected in the recent cases.

Technical skills are no longer enough for a doctor to fulfil his or her duties. Doctors must now have good communication skills. The court's finding for the plaintiff in Chappel reinforced the view that informed consent requires doctors at the very least, to listen to and respond to the questions and concerns of their patients.

The other cases also suggest that there may also be arising an obligation on the part of doctors to be more proactive in informing patients about matters of risk. Doctors can no longer defend themselves on the basis of what the 'usual practice' of the profession has been.

The decision of the Ontario court (General Division) in Miles v. Judges seems to best reflect that change. In that case it will be recalled, the trial judge held it was a doctor's duty to disclose his inexperience with respect to a particular surgical procedure that his patient required. This was so, even though it had generally been accepted that medical practitioners did not normally discuss their surgical experience with patients unless specifically asked.

The need for greater openness within the health system has been demonstrated by a recent medical scandal in England (Commission of Inquiry into the Bristol Royal Infirmary). It resulted in a General Medical Council Inquiry into fifty-three pediatric cardiac operations at the Bristol Royal Infirmary in which twenty-nine children died and four were left with brain damage following surgery.

Formal action by the General Medical Council resulted only after a consultant anaesthetist went over the head of the chief executive officer of the hospital and 'blew the whistle'. The factors that discouraged openness and frankness about a doctor's personal and professional performance were identified as key in explaining how the scandal occurred. It became evident, during the course of the Bristol Inquiry, that the parents of the children who had died had not been told of the significant medical dispute going on in that hospital over whether the hospital should continue to offer certain surgical procedures despite poor results. The General Medical Council suspended two of the doctors involved from practising medicine as a result of their conduct. On June 18, 1998, a Commission of Inquiry was appointed to look into the matter.

In this report, one of the major issues that will be explored is the question of whether the families of the deceased children were fully informed about events within the Pediatric Cardiac Surgery Program at the HSC in 1994. The Report will examine whether that information was something that the parents ought to have known before giving their consent to the surgical procedures involving their children. The Report will also explore the question of what the parents were told about the risks associated with the surgical procedure that their children were about to undergo, as well as the nature of what information surrounding risk they were told and ought to have been told.

In order to make any recommendations concerning what the hospital or government might have to do in the area of informing parents and patients of their rights, or ensuring that those rights are properly respected, conclusions will have to be reached as to what parents were told and whether their consents were or may not have been validly obtained.

In doing so, I recognize that I may be treading close to the line of pronouncing on the culpability of individuals or institutions. I feel, however, that in order to prevent the events of 1994 from being repeated, recommendations should be made about the nature and type of information that patients and their families are entitled to and ought to be provided. Therefore, when discussing this and other areas of similar importance, the language used will need to be carefully considered.



Current Home - Table of Contents - Chapter 1 - The law of medical consent
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Previous The issue of consent
Section 1 Chapter 1 - Introduction to the Issues
  Chapter 2 - Pediatric Cardiac Issues
  Chapter 3 - The Diagnosis of Pediatric Heart Defects and their Surgical Treatment
  Chapter 4 - The Health Sciences Centre
Section 2 Chapter 5 - Pediatric Cardiac Surgery in Winnipeg 1950-1993
  Chapter 6 - The Restart of Pediatric Cardiac Surgery in 1994
January 1, 1994 to May 17, 1994
  Chapter 7 - The Slowdown
May 17 to September 1994
  Chapter 8 - Events Leading to the Suspension of the Program
September 7, 1994 to December 23, 1994
  Chapter 9 - 1995 - The Aftermath of the Shutdown
January to March, 1995
Section 3 Chapter 10 - Findings and Recommendations
Appendix 1 - Glossary of terms used in this report
Appendix 2 - Parties to the Proceedings and counsel
Appendix 3 - List of witnesses and dates of testimony
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