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Crisis and Informed Consent: Analysis of a Law-Medicine Malocclusion

Published online by Cambridge University Press:  24 February 2021

Fran Carnerie
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Abstract

Many individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.

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Articles
Information
American Journal of Law & Medicine , Volume 12 , Issue 1 , 1986 , pp. 55 - 97
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1986

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References

1 The phenomenon of depersonalization in health care has been widely studied and discussed by medical sociologists and ethicists. For some of the more prominent readings, see 1. Illich, Limits to Medicine, Medical Nemesis: The Expropriation of Health (1977); T. Mckeown, The Role of Medicine: Dream, Mirage, or Nemesis? (1979); C. Dollery, The End of an Age of Optimism: Medical Science in Retrospect and Prospect (1978).

2 Picard offers a comprehensive survey of the case law which has molded the informed consent doctrine in Canada. See Picard, The Tempest of Informed Consent, in Studies in Canadian Tort Law 129 (L. Klar ed. 1977).

3 Hayward, Informed Consent from a Medical Viewpoint, Access Alberta 5 (1983).

4 Autonomy has been defined as:

[A] form of personal liberty of action where the individual determines his or her own course of action in accordance with a plan chosen by himself or herself. The autonomous person is one who not only deliberates about and chooses such plans but who is capable of acting on the basis of such deliberations, just as a truly independent government formulates policies. A person's autonomy is his or her independence, self reliance and self-contained ability to decide. See T.L. Beauchamp & J.F. Childress, Principles of Biomedical Ethics 56 (1979).

5 The association between the discovery of a chronic and/or life threatening disease and the ensuing development of crisis is well established in psychiatric literature. See the classical works of crisis theoretician, G. Caplan, Principles of Preventative Psychiatry 35 (1964); see also Parad & Caplan, A Framework for Studying Families in Crisis, in Crisis Intervention: Selected Readings 56 (HJ. Parad ed. 1965); D.C. Aguilera & J.M. Messick, Crisis Intervention: Theory and Methodology 84 (1974); L.A. Hoff, People in Crisis: Understanding and Helping 12 (1978).

6 Bloom, Definitional Aspects of the Crisis Concept, in Crisis Intervention: Selected Readings, supra note 5, at 304; G. Caplan, supra note 5, at 40-41; N. Hansell, The Person in Distress: on the Biosocial Dynamics of Adaptation 15-29 (1976).

7 Male v. Hopmans, [1966] 1 O.R. 2d 647, 650.

8 For example, 52,624 Canadians were diagnosed with cancer in 1980. Cancer in Canada, Statistics Canada: Ministry of Supply and Services (1983). In a study dealing with newly diagnosed cancer patients, it was found that ten percent of the patients had such diminished ability to deal with information that they professed to have no knowledge of their diagnosis, despite being told of it. (Methodological flaws in the study that may limit the generalizabiiity of these data are discussed. The reader is cautioned accordingly.)

Absence of knowledge following disclosure is a signpost of crisis in only one facet of one disease. Psychological challenges arise at all stages of catastrophic disease, such as investigation, treatment, rehabilitation, recurrence, and realization of terminality. Devastating and commonly occurring illnesses affecting Canadians include cardiovascular disorders, such as heart attack and hypertension; neurological diseases, including stroke and multiple sclerosis; endocrine disorders, like diabetes; musculoskeletal disorders, like rheumatoid and osteoarthritis; infectious diseases, such as meningitis and AIDS; mental or emotional diseases, including Alzheimer's, alcoholism and schizophrenia; and trauma, to name only a few. See infra note 14.

Some appreciation for the potential to develop crisis can be had by taking the psychological challenges of disease, multiplying them by the stages of chronic illness, and multiplying again by the number of fatal or incapacitating disorders affecting Canadians. See infra note 15.

9 Somerville, , Structuring the Issues in Informed Consent, 26 Mcgill L.J. 740, 741 (1981)Google Scholar.

10 See Rozovsky, Informed Consent and Investigational Drugs, 1 L. Med. Q. 162, 163 (1977). In this article, Professor Rozovsky advocates that the consent to treatment issue be kept “in its proper perspective” and “the development of legal rules to govern every conceivable type of consent situation” be avoided. Given the ubiquitous nature of serious illness in the lives of Canadians, however, and the concomitant potential for crisis development, there is a pressing need for legal guidelines, especially if courts tend not to scrutinize such cases.

11 For support of this observation, see Meisel, & Roth, , What We Do and Do Not Know About Informed Consent, 246 J.A.M.A. 2473 (1981)CrossRefGoogle Scholar.

12 Appelbaum, & Roth, , Clinical Issues in the Assessment of Competency, 138 Am. J. Psychiatry 1462 (1981)Google Scholar.

13 Utilizing devastating disease as a vehicle to analyze the doctrine of informed consent is a technique supported by Capron, , Informed Consent in Catastrophic Disease Research and Treatment, 123 U. Pa. L. Rev.340, 349 (1974)CrossRefGoogle Scholar:

The catastrophic disease process provides a good crucible in which to formulate and test a theory of informed consent because it calls forth active and intense participation by all the actors in the drama of modern, technological medicine: physician-investigators who invent and apply the new techniques of treatment; patient-subjects in whom these techniques have their ultimate (and sometimes highly beneficial) trial runs; organized professional bodies which usually guide or support and occasionally curtail the work of the pioneers in their fields; and organs of the state which fund education and research and increasingly intervene in the actual supervision of clinical innovation.

14 A state of crisis may develop at any stage of the illness experience such as suspicion of diagnosis, investigational procedures, treatment, rehabilitation, reoccurrence, or realization of terminality. See F.C. Shontz, The Psychological Aspects of Physical Illness and Disability 158 (1975).

Confirmation of diagnosis will be the exclusive stage for discussion in this paper, as this is the critical time when information regarding medical management is imparted, and the person is required to make important decisions.

15 Many people were shown to cope effectively with their “bad news” in a study by Weisman & Worden, The Existential Plight in Cancer: Significance of the First 100 Days, 7 Int'l J. Psychiatry in Med. 1 (1976-77). However, the results of this study must be interpreted with caution. Although the study group was large (N=120), and psychological testing was done with some well established instruments, alterations were made to one tool without giving reliability/validity data, interrater reliability was not reported for the semi-structured interviews, and no control group was used.

Among crisis theoreticians and interventionists, however, there is a general consensus that the same “hazardous event” (disclosure of diagnosis in this case) evokes a variety of responses. F.C. Shontz, supra note 14, at 159; G. Caplan, supra note 5, at 41; Cohen, Crisis Intervention for Medical Problems, in Crisis Intervention 132 (L.H. Cohen, W.L. Claiborn and G.A. Specter 2d ed. 1983).

16 G. Caplan, An Approach to Community Mental Health 18 (1961).

17 G. Caplan, supra note 5, at 40.

18 N. Hansell, supra note 6, at 15-16.

19 L.A. Hoff, supra note 5, at 34-36.

20 Weisman & VVorden, in their somewhat suspect research, supra note 15, at 7, stated that despite being told of their diagnoses, ten percent of new patients in the study claimed to have no knowledge of their diagnosis, and no need for further information.

21 National Cancer Institute, Coping with Cancer 3 (1980).

22 Id.

23 G. Caplan, supra note 5, at 35; see also B.L. Bloom, Community Mental Health: A General Introduction (1977).

24 In an interesting study on neuropsychiatric patients in crisis, Smith demonstrated the relationship of changes in perception of helplessness overtime. Over a period of six weeks, the people in crisis showed a “marked change” in their feelings of being able to exert control over the situational factors in their lives. This was a well designed cohort analytic study which utilized a scale known for its construct validity; however, the sample was small (N=30) and the generalizability of results from neuropsychiatric patients to those with newly diagnosed physical illness is questionable. Smith, , Changes in Locus of Control As a Function of Life Crisis Resolution, 75 J. Abn. Psychology 329 (1970)CrossRefGoogle Scholar; see also Lewis, , Gottesman, and Gutstein, , The Course and Duration of Crisis, 47 J. Consult, and Clin. Psychology 128 (1979)CrossRefGoogle Scholar.

25 Halushka v. University of Saskatchewan, 53 D.L.R.2d 436, 442-43 (1965); see generally Lepp v. Hopp, 32 N.S.R.2d 145, 159 (1980).

26 J.R. Waltz & R.E. Inbau, Medical Jurisprudence 156 (1971).

27 Kaufmann describes informed consent as “one battle in an ongoing war between two powerful professional disciplines.” In a methodologically interesting study, the investigators compared cohorts of psychiatrists, lawyers, medical and law students (N= 130) and discovered a polarity of evaluation of mental patients’ ability to refuse or consent to ECT. Lawyers tended to prefer the patient to be the final decisionmaker, while psychiatrists favored someone other than the patient to make the final decision (38 percent choosing the patient's doctor, approximately 33 percent choosing the patient's relatives). Medical and law students were less divergent and more flexible in their ideas about patient decisionmaking. Interrater reliability test demonstrated intermediate levels of reliability (r = 0.5 to 0.84). Kaufmann, Roth, Lidz, & Meisel, Informed Consent and Patient Decisionmaking: The Reasoning of Law and Psychiatry 4 Int'l. J. L. & Psychiatry 345 (1984).

28 In 1931, Hodgins, J.A. stated that the relationship between a surgeon and patient naturally involved confidence and trust, given the knowledge, skill and experience possessed by the former. Kenny v. Lockwood, [1932] 1 O.R. 141, 155 (Ont. C.A.).

In 1933, Chisholm, C.J. stated that the patient and physician enter into a contract following the process of doctor advisement and the patient's consideration of risks and authorization of surgical treatment. Marshall v. Curry, 3 D.L.R. 260, 268 (N.S. S.C. 1933).

29 Kenny, [1932] 1 O.R. at 160-61.

30 Id.

31 Beausoleil v. La Communaute des Soeurs de la Charite, 53 D.L.R.2d 65, 76 (Que. Q.B. App. 1964).

32 Z5 O.R. 2d 290, 319 (Ont. H.C. 1976).

33 Id. at 318.

34 Male v. Hopmans, [1966] 1 O.R. 2d 647, 650.

35 13 Ariz. App. 460, 477 P.2d 746 (Ariz. Ct. App. 1970).

36 The excision of a vertebral posterior arch. Taber's Cyclopedic Medical Dictionary L-9 (12th ed. 1973).

37 This illustrates the concept of “hindsight” which vexes legal analysis of causation issues. In the landmark case of Reibl v. Hughes, 114 D.L.R.3d 1 (Can. 1980), Chief Justice Laskin delineated the dilemma:

It could hardly be expected that the patient who is suing would admit that he would have agreed to have the surgery, even knowing all the accompanying risks. His suits would indicate that, having suffering serious disablement because of the surgery, he is convinced that he would not have permitted it if there had been proper disclosure of the risks, balanced by the risks of refusing the surgery. Yet, to apply a subjective test to causation would, correlatively, put a premium on hindsight, even more of a premium that would be put on medical evidence in assessing causation by an objective standard.

38 Id. at 15-16.

39 [1974] 5 W.W.R. 606 (Man. Q.B.).

40 Id. at 610.

41 2 O.R. 2d 103, 109 (Ont. H.C. 1971).

42 Natanson v. Kline, 186 Kan. 393, 406, 350 P.2d 1093, 1103 (1960).

43 In the landmark American case of Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972), cert, denied, 409 U.S. 1064 (1972), the court ruled that a physician is not required to know precisely what a patient would consider important in making treatment decisions. It was expected, however, that physicians can anticipate the reactions of the average, reasonable patient, given their medical training, clinical experience, and knowledge of the person's background and current condition.

44 Male v. Hopmans, [1966] 1 O.R. 2d 647, 654.

45 Reibl, 114 D.L.R.3d at 7.

46 Id.

47 Smith v. Auckland Hospital Board, [1964] N.Z.L.R. 241, 250 (N.Z.S.C).

48 Reibl, 114 D.L.R.3d at 15-17.

49 Id. at 13.

50 Id.

51 Canterbury v. Spence, 464 F.2d at 767.

52 Id.

53 Id. at 794.

54 Id. at 786.

55 Id. at 786-788.

56 114 D.L.R.3d at 7.

57 Id.

58 Somerville, supra note 9, at 757.

59 Descriptions found in Canadian and American medical jurisprudence include: “fundamental versus collateral” risks, as well as those which are “remote,” “definite,” “special,” “usual,” “certain,” or “occasional.“

60 Somerville, supra note 9, at 746.

61 Lepp v. Hopp, 32 N.R. 145, 159 (Can. 1980).

62 15 Can. Cases on L. of Torts 81,99 (Ont. H.C. 1981), aff'd, (1982), 20 Can. Cases on L. of Torts xxii (Ont. C.A.).

63 20 Can. Cases on L. of Torts 301 (B.C. S.C. 1982).

64 Reibl v. Hughes, 114 D.L.R.3d at 8. For an interesting commentary on the trend of quantifying risk assessment, see E. Picard, Legal Liability of Doctors and Hospitals in Canada 96 (2d ed. 1984).

65 Canterbury v. Spence, 464 F.2d at 794.

66 Lepp v. Hopp, 32 N.R. 145 (Can. 1980).

67 Id. at 160 (quoting Waltz, & Scheuneman, , Informed Consent to Therapy, 64 Nw. U.L. Rev. 628, 640 (1970)Google Scholar. The Court of Appeals for the District of Columbia Circuit adopted this principle in Canterbury v. Spence, 464 F.2d at 787.

68 This description pertains to the situation which is the more challenging for physicians: where the patient does not ask any questions about a proposed therapeutic treament. Where the person requests information from the physician, all possible information must be disclosed. For a useful commentary on the antiquity of “full disclosure” standards, see Somerville, supra note 9, at 754-55.

69 Reibl v. Hughes, 114 D.L.R.3d at 17. In this excerpt, Laskin, C.J.C., was discussing the standards with respect to their impact on causation issues.

70 Id. at 13.

71 Somerville, supra note 9, at 761. The author offers an interesting risk classification system designed to overcome the ambiguities in current case law. Id. at 760-61.

72 For example, some forms of cancer are partially or totally unresponsive to current regimes of radiotherapy and chemotherapeutic drugs. These anti-cancer treatments, however, have many distressing and sometimes fatal side effects.

73 Kelly v. Hazlett, 15 O.R. 2d 290, 318 (Ont. H.C. 1976).

74 J.R. Waltz & R.E. Inbau, supra note 26, at 164.

75 Mosk, J. in Cobbs v. Grant, 8 Cal. 3d 229, 244, 502 P.2d 1, 11, 104 Cal. Rptr. 505, 515 (1972), stated:

[T]he patient's interest in information does not extend to a lengthy polysyllabic discourse on all possible complications. A mini-course in medical science is not required; the patient is concerned with the risk of death or bodily harm, and problems of recuperation.

See also Johnston v. Wellesley Hosp., [1970] 2 Ont. 2d 103.

76 15 O.R. 2d 290 (Ont. H.C. 1976).

77 Id. at 296.

78 Id. at 318.

79 71 Nev. 280, 283, 269 P.2d 173, 175 (1955).

80 Salgo v. Leland Stanford Jr. University Bd. of Trust., 154 Cal. App. 2d 560, 578, 317 P.2d 170, 181 (1957).

81 Smith v. Auckland Hosp. Bd., [1964] N.Z.L.R. at 253.

82 Id. at 250.

83 “The physician is in the greatest dilemma here. He cannot oversell, but he can't afford to be so honest about the treatment that he raises unnecessary fears and anxieties in the patient. It is often a difficult balance to maintain. Most physicians lean in favour of overselling to avoid disturbing the patient.” Curran, Professional Negligence—Some General Comments, 12 Vand. L. Rev. 535, 543 (1958-59).

84 Tancredi, , Competency for Informed Consent: Conceptual Limits of Empirical Data, 5 Int'l. J.L. & Psychiatry 51, 62 (1982)CrossRefGoogle Scholar.

85 Reibl v. Hughes, 114 D.L.R.3d at 7.

86 Male v. Hopmans, [1966] 1 O.R. 2d at 650; Kenny v. Lockwood, [1932] 1 O.R. at 165.

87 Male v. Hopmans, [1966] 1 O.R. 2d at 650. The court ruled that presence of considerable pain and high fever were factors that would affect a person's ability to appreciate information. The Ontario Court of Appeal affirmed. [1967] 2 O.R. 2d 457, 465.

88 Salgo v. Leland Stanford Jr. University Bd. of Trust., 154 Cal. App. 2d at 578, 317 P.2d at 181.

89 “Competence” is the term used in the medical vernacular.

90 Tancredi, supra note 84, at 54.

91 Kelly v. Hazlett, 15 O.R. 2d at 319.

92 Beausoleil v. La Communaute des Soeurs de la Charite, 53 D.L.R.2d 65 (1964).

93 In re Eve, 79 Atl. Prov. 359 (1981).

94 Rozovsky, Consent to Treatment, 11 Oscoode.Hall L.J. 103, 110-11 (1973).

95 Examples of such legislation include: Incompetent Persons Act, N.S. Rev. Stat. ch. 135, § 1(b) (1967) (” ‘Insane person’ or ‘lunatic’ includes a person, not an infant, who is incapable from infirmity of mind of managing his own affairs.“) Mental Health Act, Ont. Rev. Stat. ch. 262, § 1(g) (1980) (“'Mentally competent’ means having the ability to understand the subject-matter in respect of which consent is requested and able to appreciate the consequences of giving or withholding consent“); Infirm Persons Act, N.B. Rev. Stat. ch. 1-8, § 1(b) (1973) (” ‘Mentally incompetent person’ means a person … who is suffering from such a disorder of the mind … that he requires care, supervision and control for his protection or welfare or for the protection of his property“; “ ‘mental incompetency’ means the condition of mind or physical incapacity of a mentally incompetent person.“).

96 For instance, the regulations enacted pursuant to The Public Hospitals Act in Ontario (Ont. Rev. Stat. ch. 410 (1980)) provide:

No surgical operation shall be performed on a patient or an outpatient unless a consent in writing for the performance of the operation has been signed by, (c) the spouse or a parent, guardian or next of kin of the patient or outpatient, as the case may be, where the patient or outpatient is unable to consent in writing by reason of mental or physical disability (emphasis added).

These legislative criteria do little to clarify the ambiguity of competency assessment that exists in the common law.

97 Roth, , Meisel, & Lidz, , Tests of Competency to Consent to Treatment, 134 Am. J. Psychiatry 279, 280 (1977)Google Scholar.

98 Id. at 280-82.

99 114 D.L.R. 3d at 17.

100 Id. at 16-17.

101 [1966] 1 O.R. 2d at 650.

102 Roth, Meisel & Lidz, supra note 97, at 281.

103 Id. at 282.

104 15 Ont. 2d at 319.

105 Roth, Meisel & Lidz, supra note 97, at 282.

106 Id. at 283.

107 Tancredi, supra note 84, at 54.

108 Id. The interrelationships of competency, testing and autonomy are represented as follows:

This chart is based upon the combined works of Roth, Meisel 8c Lidz, supra note 97, and Tancredi, supra note 84.

109 Roth, Lidz, Meisel, Soloff, Kaufman, Spiker & Foster, Competency to Decide About Treatment or Research: An Overview of Some Empirical Data, 5 INT'L. J.L. & Psychiatry 29 (1982). This study was complicated largely due to maneuvers designed to reduce bias and increase the validity of the findings. Consistency in rater scoring could have been undertaken to strengthen the data.

110 Id. at 46-47.

111 Law Reform Commission of Canada, Working Paper 26: Medical Treatment and Criminal Law 68 (1980).

112 Professor Picard holds the view that if a doctor is in doubt regarding the competency of a patient, a psychiatrist should be consulted rather than relying on the patient's subjective understanding. See E. Picard, supra note 64, at 61. Owing to the values divergence between psychiatrists and lawyers, see supra note 27, the result reached by the medical profession has the potential to meet a lower standard of civil rights protection for the patient.

113 Myers, , Informed Consent in Medical Malpractice, 55 Calif. L. Rev. 1396, 1409 (1967)CrossRefGoogle Scholar.

114 Freedman, A Moral Theory of Informed Consent, 5(4) Hastings Ctr. Rpt. 32 (August 1975).

115 Cobbs v. Grant, 104 Cal. Rptr. 505, 516, 502 P.2d 1, 11 (1972).

116 53 D.L.R.2d 65, 76 (1964).

117 Rozovsky, supra note 94, at 107.

118 53 D.L.R.2d 436, 443 (1965).

119 Reibl v. Hughes, 114 D.L.R.3d at 10.

120 Tancredi, supra note 84, at 54.

121 Kelly, 15 O.R. 2d at 297.

122 Meisel, Roth & Lidz, Toward a Model of the Legal Doctrine of Informed Consent, 134 Am. J. Psychiatry 285, 296 (March 1977).

123 Plante, An Analysis of Informed Consent, 36 Fordham L. Rev. 639, 653-54 (1968).

124 In Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (1960), a woman sustained extensive injuries to her chest wall as a result of therapy with radioactive cobalt. The court held that ”… there was no immediate emergency concerning the administration of cobalt irradiation treatment such as would excuse the physician from making a reasonable disclosure to the patient.” Id. at 1106.

125 Meisel, Informed Consent: Who Decides for Whom﹜ in Medical Ethics and the Law: Implications for Public Policy (M. Hiller ed. 1981).

126 Smith v. Auckland Hospital Board, [1964] N.Z.L.R. at 250.

127 Meisel, supra note 125, at 209.

128 Freedman, supra note 114, at 34.

129 114 D.L.R.3d at 13.

130 Natanson v. Kline, 186 Kan. at 406, 350 P.2d at 1103.

131 Salgo v. Leland Stanford Jr. University Bd. of Trust., 154 Cal. App. 2d at 578, 317 P.2d at 181.

132 Jazvac, Informed Consent: Risk Disclosure and the Canadian Approach, 36 U. of Toronto. Fac. L. Rev. 191, 192-94 (1978).

Although Jazvac has comprehensively addressed the issue of therapeutic privilege, he founded some of his legal arguments on one article which offered no empirical authority for its conclusion, Markham, The Doctrine of Informed Consent: Fact or Fiction, 1974 A.B.A. Forum 1073. There is no empirical support for stating that the risk of perforating the esophagus during gastroscopy is increased following the “negative physical results from risk disclosure“). Id. at 1077. Further, reliance was placed on another study which was methodologically flawed, Alfidi, , Informed Consent: A Study of Patient Relations, 216 J.A.M.A. 1325 (1971)CrossRefGoogle Scholar. Alfidi does not report how the sample of patients was selected, nor the representativeness of the sample, which jeopardizes the generalizability of his findings. Also, there are no reliability and validity data reported for the newly-developed questionnaire and no control group to eliminate independent variables.

The importance of highly selective, well-critiqued empirical literature cannot be overstated, if legal abstractions are to be based upon them.

133 In legal literature, this may also be referred to as surrogate consent, while in medical and ethics literature, it may be called consent by proxy. This is one example of the jargonism that tends to characterize the informed consent doctrine. The danger inherent in this is that ”… it is easy to wander off in a mishmash of generalities and catch-words that breeds the intellectual chaos that has existed in this area in the past few years.” Plante, supra note 123, at 640.

134 Frenkel, , Consent of Incompetents (Minors and the Mentally III) to Medical Treatment, 1 L. Med. Q. 187, 189 (1977)Google Scholar.

135 Freedman, supra note 114, at 38.

136 J.R. Waltz & R.E. Inbau, supra note 26, at 169.

137 See In Re Eve, 79 Atl. Prov. 359 (1981), for an example of a court practicing in this parens patriae capacity.

138 Meisel, supra note 125, at 212.

139 See supra note 8.

140 See supra note 96.

141 See, e.g., Reibl v. Hughes, 114 D.L.R.3d 1.

142 Liebert, , Informed Consent: An Imperative Impossibility, 48 Am. Surgeon 225 (1982)Google Scholar.

143 Goldstein, , For Harold Lasswell: Some Reflections on Human Dignity, Entrapment, Informed Consent, and the Plea Bargain, 85 Yale L.J. 673, 691 (1975)Google Scholar.

144 Testicular cancer is the most common carcinoma of men in this age group. University of Rochester School of Medicine and Dentistry, Clinical Oncology for Medical Students and Physicians: A Multidisciplinary Approach 150 (American Cancer Society 1976).

145 See Meisel, infra note 156, at 433.

146 Cohen, supra note 15, at 133; Bloom, supra note 6, at 304; Rapoport, Normal Crises, Family Structure, and Mental Health, in Crisis Intervention: Selected Readings,supra note 5, at 75.

147 This position is supported by Tancredi,supra note 84, at 56. He states that in periods of crisis, the patient is incapable of making an objective decision about proposed care. Although some patients “[m]ay be strongly ambivalent about surrendering control over what happens to their bodies … many patients may desire to surrender control over these decisions in the hope that others might be better able to handle the anxieties aroused by the need to select the course of treatment.” (emphasis added).

148 L.A. Hoff, supra note 5, at 21.

149 The doctrine of informed consent gained prominence in Canada with decisions from the 1930's. See Kenny v. Lockwood, [1932] 1 O.R. 141; Marshall v. Curry, 3 D.L.R. 260 (1933). Since then, consumers have generally become more sophisticated and knowledgeable about health care provisions. The result is a growing wariness about medical care and the generalized desire for greater autonomy in decisionmaking. See supra note 1.

150 Appelbaum & Roth, supra note 12, at 1462.

151 Ingelfinger, , Informed (But Uneducated) Consent, 287 New Eng. J. Med. 465 (1972)CrossRefGoogle Scholar.

152 Lidz, , Meisel, , Osterweis, , Holden, , Marx, & Munetz, , Barriers to Informed Consent, 99 Annals Int. Med. 539 (1983)CrossRefGoogle Scholar.

153 Fletcher, & Fletcher, , Clinical Research in General Medical Journals, 301 New Eng. J. Med. 180, 183 (1979)CrossRefGoogle Scholar.

154 Ederer, , Patient Bias, Investigator Bias and the Double-Masked Procedure in Clinical Trials, 58 Am. J. Med. 295, 299 (1975)CrossRefGoogle Scholar.

155 Meisel & Roth, supra note 11, at 2473.

156 Meisel, The ‘Exceptions’ to the Informed Consent Doctrine: Striking A Balance Between Competing Values in Medical Decisionmaking, Wis. L. Rev. 413, 424 (1979).

157 Schneyer, , Informed Consent and The Danger of Bias in the Formation of Medical Disclosure Practices, 124 Wis. L. Rev. 124, 158 (1976)Google Scholar.

For a more detailed treatment of health policy and public ethics, see Hiller, Medical Ethics and Public Policy, in Medical Ethics and the Law: Implications for Public Policy, supra note 125, at 1.

158 Brief as Amicus Curiae for the Conference of State and Territorial Epidemiologists, Reyes v. Wyeth Labs, Inc., 498 F.2d 1264, 1276 (5th Cir. 1974).

159 Reyes, 498 F.2d 1264 (5th Cir. 1974).

160 Id. at 1282.

161 Leeb, , Bowers, & Lynch, , Observations on the Myth of'Informed Consent,’ 58 Plas. Recon. Surg. 180, 281 (1976)CrossRefGoogle Scholar. This was an analytic investigation to ascertain patient recall of information which included warnings, long and short range expectations, and potential problems.

Specific information which constituted the “informing” part of consent was reported and a large sample was used (N= 100). However, no data regarding the statistical strength of the interview format was provided. In addition, use of a cohort group would have been fortifying.

162 Dodd & Mood, Chemotherapy: Helping Patients to Know the Drugs They Are Receiving and Their Side Effects, Cancer Nursing 311 (August 1981). A two-part study was conducted to determine the role of the nurse in reviewing chemotherapy information with the patients. The subsequent random assignment phase was based on the information produced by the initial descriptive phase, which includes the data reported above.

The descriptive phase would have been methodologically strengthened, however, with the use of a control group, a greater number of subjects (N=30), and reliability/validity data for their instrument. It would have been of further assistance to report more precisely the time lapse between physician disclosure and time of recall testing.

163 Id. at 312.

164 Priluck, , Robertson, & Buettner, , What Patients Recall of the Preoperative Discussion After Retinal Detachment Surgery, 87 Am. J. Ophthalmology 620, 623 (1979)CrossRefGoogle Scholar; Liebert, supra note 142, at 229.

165 Frazer & Hiatt, Evaluation of Medical Practices, 200 Science 875, 875-78 (1978).

166 Tancredi, supra note 84, at 61.

167 In Lepp v. Hopp, 32 N.R. 145, 149 (Can. 1980), the court considered the surgeon's qualifications and whether a hemilaminectomy could be performed as well in Lethbridge as in Calgary. The Supreme Court of Canada upheld the findings of the trial judge who ruled that there may be an advantage in having the surgery in Calgary, but that there was no probability of special or unusual risk that would oblige the surgeon to alert the patient.

168 Kessenick, & Mankin, , Medical Malpractice: The Right to be Informed, 8 U.S.F.L. Rev. 261, 272 (1973)Google Scholar.

169 Lidz, Meisel, Osterweis, Holden, Marx & Munetz, supra note 152, at 540.

170 Kessenick & Mankin, supra note 168, at 279.

171 Lidz, Meisel, Osterweis, Holden, Marx & Munetz, supra note 152, at 540.

172 Novack, , Plumer, , Smith, , Ochtill, , Morrow, & Bennett, , Changes in Physicians’ Attitudes Toward Telling the Cancer Patient, 241 J.A.M.A. 897 (1979)CrossRefGoogle Scholar. This research duplicated a 1961 study where it was discovered that 90 percent of physicians sampled (N=219) preferred to not tell cancer patients their diagnoses.

In this 1977 study, of the 278 physicians who responded, 98 percent reported that it was their general policy to tell the patient. The investigators commented that although the two studies were diametrically opposite in preferences for telling, physician rationale for their disclosure behavior was identical: their policies were supported by strong belief and emotional investment in its being right.

It is most distressing to find, however, that these empirical results are of questionable utility. As interesting as the findings were, they were founded on a major methodological weakness—the research tool was statistically not tested for data pertaining to its reliability and validity. Although the sample was large, there was no cohort used, which further diminished its strength.

173 Id. at 898.

174 Mcintosh, , Processes of Communication, Information Seeking and Control Associated with Cancer: A Selective Review of the Literature, 8 Soc. Sci. & Med. 167, 172 (1974)CrossRefGoogle Scholar.

175 Novack, Plumer, Smith, Ochtill, Morrow & Bennett, supra note 172, at 898.

176 Although the lowered mood and associated symptoms of depression are found in other chronic and life-threatening diseases, the generalization of these data to non-cancer patients should be undertaken cautiously.

177 Lloyd, Psychological Stress and Coping Mechanisms in Patients with Cancer, in Mind and Cancer Prognosis 47, 55 (B. Stoll ed. 1979); Litin, , Should the Cancer Patient Be Told?, 28 Postgraduate Med. 470, 473 (1960)CrossRefGoogle Scholar.

178 Faden, , Disclosure Standards and Informed Consent, 6 J. Health Pol., Pol'y & L. 255 (1981)CrossRefGoogle Scholar.

179 Seizural disorders are chronic diseases requiring lifelong medication and are sometimes associated with fatal complications. Thus, they may be incorporated into this discussion with comfort.

180 It is interesting to note that the investigators felt that although the doctors disclosed what they perceived the patients wanted to know, they consistently and substantially underestimate the amount of information patients want. Faden, supra note 178, at 274-75.

181 Id. at 277.

182 Dodd & Mood, supra note 162, at 315.

183 B. Glaser & A. Strauss, Awareness of Dying (1965).

184 Id. at 134.

185 Hogshead, The Art of Delivering Bad News, in Psychological Care of the Dying Patient 128 (C. Garfield ed. 1978).

186 Chodoff, , Friedman, & Hamburg, , Stress, Defenses and Coping Behaviour: Observations in Parents of Children with Malignant Disease, 120 Am. J. Psychiatry 743, 745 (1964)CrossRefGoogle Scholar.

187 For an informative summary of the issues involved, see Green, Truth Telling in Medical Care, in Medical Ethics and the Law, supra note 125, at 183.

188 Psychosocial literature refers to this process as the “Conspiracy of Silence” where the need to deny that anything is amiss in the family is enacted by refusing permission to discuss the issue. Physicians may therefore be faced with incongruous adaptation to a crisis situation by the patient and family, resulting in conflicting demands regarding communication. For further discussion of this subject, see Vettese, Family Stress and Mediation in Cancer, in Living and Dying with Cancer 273 (P. Ahmed ed. 1981).

189 Mcintosh, supra note 174, at 175-76.

190 Id. at 176.

191 Id. at 179.

192 Harker, , Cancer and Communication Problems: A Personal Experience, 3 Psychiatry in Med. 163, 164 (1972)CrossRefGoogle Scholar.

Personal accounts, like case studies, tend to give an unbalanced account of information. The phenomenon of silent glances is presumably ubiquitous, however, and given that the author was a masters-prepared social sciences lecturer at UCLA, her views have been included here.

193 Lidz, Meisel, Osterweis, Holden, Marx & Munetz, supra note 152, at 540-41.

194 The generalizability of the data may be questioned here. Although the sample size was large (N=101), the subjects were exclusively from a medical cardiology unit, a surgical unit, and a surgical outpatient unit in a university teaching hospital. There are no other demographical data reported. Id. at 539.

195 The investigators anecdotally reported that one subject had felt deprived of information not because he was concerned about rationale for or risks associated with tests and procedures, but rather because he wanted to mentally prepare for his operation. Id. at 540.

196 Id. at 541.

197 Cassileth, , Zupkis, , Sutton-Smith, & March, , Information and Participation Preferences Among Cancer Patients, 92 Annals Int. Med. 832 (1980)CrossRefGoogle Scholar.

198 Id. at 835.

199 For Cassileth's correlation between the types of information most wanted and percentage of patients desiring this information, see id. at Appendix A.

200 Cassileth, Zupkis, Sutton-Smith & March, supra note 197, at 834.

201 Id. at 835.

202 Denney, , Williamson, & Penn, , Informed Consent: Emotional Responses of Patients, 60 Postgraduate Med. 205 (1975)CrossRefGoogle Scholar.

203 Lidz, Meisel, Osterweis, Holden, Marx & Munetz, supra note 152, at 541-42.

204 This finding is not incompatible with a crisis model, since the surprise associated with diagnosis and treatment phases would have long since dissipated.

205 This phenomenon is consistent with regressive and emotionally dependent behaviour which manifests itself in hospital settings. For further readings on the “sick role,” see T. Parsons, The Social System (1951); and T. Parsons, Social Structure and Personality (1964).

206 Lidz, Meisel, Osterweis, Holden, Marx & Munetz, supra note 152, at 540.

207 Id.

208 Ingelfinger, supra note 151, at 466.

209 M.J. Fromer, Ethical Issues in Health Care 330 (1981).

210 Id.

211 Sharpe, , Consent to Medical Treatment, 22 Chitty's L.J. 319, 321 (1974)Google Scholar. He adds that the sign-or-no-treatment pressure exerted on an already over-anxious patient may be sufficient duress to vitiate the consent.

In another interesting work, Sharpe treats voluntariness in informed consent from a contractual perspective. See G. Sharpe, Informed Consent: Its Basis in Traditional Legal Principles 48-49 (1979).

212 Appelbaum & Roth, supra note 12, at 1465.

213 Id. The disease and treatment factors initiated by the authors refer specifically to psychiatric medicine. It is submitted, however, that the factors are readily generalizable to the present situation, as these factors influence whether or not an individual develops a crisis state in the first instance.

214 Ball, The “Voiceless” From a Medical/Legal Viewpoint, Access Alberta 8 (1983). This background paper is most helpful in taxonomizing key issues to be considered in incompetence assessment.

215 Appelbaum & Roth, supra note 12, at 1465.

216 Id. at 1464.

217 Liebert, supra note 142, at 227.

218 Stanley, , Guido, , Stanley, & Shortell, , The Elderly Patient and Informed Consent: Empirical Findings, 252 J.A.M.A. 1302, 1304 (1984)CrossRefGoogle Scholar. This was a cohort analytic trial (N=80) with a number of measures introduced to limit variables in the sample (vision, hearing and psychiatric screening, measures of intelligence and attention span) as well as mechanisms to control bias, like interrater reliability testing.

219 Id. at 1304-05. The general application of these data must be questioned, however, based on the presence of medical illness in the elderly sample (heart problems, diabetes and asthma most commonly), as well as failure to report from which “facilities” the subjects were recruited. The elderly performed somewhat more poorly than the young in two research descriptions, without opposite risk-benefit ratios.

220 Tancredi, supra note 84, at 58.

221 Lesser, , Consent, Competency and ECT: A Philosopher's Comment, 9 J. Med. Eth. 144 (1983)CrossRefGoogle Scholar.

222 Id. at 145.

223 Negativity represents the lack of an attribute, while falsely negative means that there is no such deficiency.

224 Appelbaum & Roth, supra note 12, at 1466.

225 Freedman, supra note 114, at 32.

226 Editorial, Impaired Autonomy and Rejection of Treatment, J. Med. Eth. 131, .132 (1983). The editor was commenting on the peril inherent in a proposal made by Sherlock, who suggested that in order to preserve a person's autonomy, evidence of impairment should justify compulsory treatment to optimize autonomy. Sherlock would cast a moral obligation on the physician to treat a person with ECT even without consent since the likelihood of therapeutic benefit is high and alternatives non-existent or doubtful. See Sherlock, Consent, Competency and ECT: Some Critical Suggestions, 9 J. Med. Eth. 141, 141-43 (1983).

227 Taylor, , Consent, Competency and ECT: A Psychiatrist's View, 9 J. Med. Eth. 146, 150 (1983)CrossRefGoogle Scholar.

228 Frenkel, supra note 134, at 190.

229 Id.

230 Weisman & Worden, supra note 15, at 11. Subject to the methodological limitations outlined in note 15, the data suggest that 20 percent of the newly diagnosed cancer patients studied (except lung cancer patients: 8 percent) reported feelings of alienation. Vulnerability scores were highest in the presence of marital problems and past regrets. Id. at 8.

231 Chodoff, Friedman, & Hamburg, supra note 186, at 748-49.

232 Meisel, supra note 156, at 433.

233 Ontario Interministerial Committee on Medical Consent, Options on Medical Consent 4 (1979). This suggestion appears as section 10 in a legislative draft prepared by the International Committee. The Draft Health Care Services Consent Act attempted remediation of identified problem areas in medical consent in Ontario. As yet, this bill has not been enacted.

234 National Cancer Institute, the Breast Cancer Digest 11 (1980).

235 Id.

236 Id.

237 Fobair & Mages, Psychological Morbidity Among Cancer Patient Survivors, in Living and Dying with Cancer, supra note 188 at 288-89. The authors report these findings from a sample of only 31 newly diagnosed cancer patients, with vague sociodemographics provided. These results replicate those from a study by Grandstaff with 340 patients, however, and are included here. Id.

238 National Cancer Institute, Coping with Cancer: A Resource for the Health Professional 10 (1980).

239 Farber, , Informed Consent, 8 J. Derm. Surg. & Oncol. 38, 39 (1982)CrossRefGoogle Scholar. Farber advocates that elective surgery be delayed until the patient is better psychologically prepared to accept risks. Unfortunately, he also takes away with a paternalistic hand in labelling “the emotionally charged, borderline psychopathic patient…” as being “dangerous,” then warning the reader to “be wary in dealing with the type … .” Id.

240 Cal. Health & Safety Code §§ 7185-7195 (West Supp. 1987).

241 See Taylor, supra note 207, at 148.

242 Id.

243 Morrow, , Gootnick, & Schmale, , A Simple Technique for Increasing Cancer Patients’ Knowledge of Informed Consent to Treatment, 42 Cancer 793 (1978)3.0.CO;2-C>CrossRefGoogle Scholar. The investigators used a large sample (N = 77), random division procedures, and structured interviews to decrase bias. Generalization to all crisis patients may be somewhat limited by the fact that all subjects were diagnosed with cancer. Men were found to benefit more from the intervention than the women subjects who demonstrated higher initial awareness of the informed consent areas.

244 The researchers offered the following guidelines to improve informed consent to treatment documents:

Write short, declarative sentences.

Use one and two syllable words any time you can.

Assess readability using Fry or Flesch scales.

Have patients and non-professionals critique proposed documents.

Have patients take consent documents home before signing.

Id. at 12. Morrow, , Bennett, & Carpenter, , Informed Consent to Treatment in Clinical Trials, 37 Biomed. Pharm. 10 (1983)Google Scholar. The investigators found that approximately 73 percent of the informed consent descriptions of cancer treatment methods, procedures, discomforts and risks required a reading ability of college level or greater. Their conclusion was that less than one-third of the population of the U.S. would be likely to understand the forms, which would further decrease in people over the age of 65.

245 Glass, , Restructuring Informed Consent: Legal Therapy for the Doctor-Patient Relationship, 70 Yale L.J. 1533, 1546 (1970)Google Scholar. Glass warns of the harmful effects of depersonalization in health care, citing mistaken diagnoses, poor medical decisionmaking and practice, or escalating patient anxiety as possible results of this phenomenon.

246 Epstein, & Lasagna, , Obtaining Informed Consent: Form or Substance, 123 Arch. Int. Med. 682, 686 (1969)CrossRefGoogle ScholarPubMed.

247 Id.

248 In using this intervention, care must be taken to ensure that the information given by the nurse is reinforcing what the doctor disclosed, and is not contradictory or tangential. The best way to accomplish this is for physicians to record the information communicated to the patient and for nurses to ascertain precisely what has been disclosed to the patient in the event of incomplete or inadequate records. Rodgers-Magnet, Recent Developments in the Doctrine of Informed Consent to Medical Treatment, 14 Can. Cases on L. of Torts 61, 77.

249 Dodd & Mood, supra note 162. In the well-designed second phase of this study, nurses visited patients at home to relay information to them after the physician had obtained informed consent. The experimental group recognized significantly more names of drugs they were receiving, and recalled more side effects, including those which were potentially lethal. See also Taylor, supra note 227, at 148.

250 See supra note 111, at 66.

251 Faden, supra note 178.

252 Id. See also Novack, Plumer, Smith, Ochtill, Morrow & Bennett, supra note 172.

253 Farber, supra note 239, at 39.

254 Hayward states that physicians also require a course which will engender an appreciation of the moral principles underlying the legal doctrine of consent, in order to cultivate an informed consent mentality into the therapeutic process. Hayward, supra note 3, at 6-7.

255 See National Cancer Institute, supra note 238, at 11.

256 Id.

257 Hogshead, supra note 185, at 128-9.

258 Morrow & Hoagland, Physician-Patient Communications in Cancer Treatment, Proceedings of the American Cancer Society Third National Conference on Human Values and Cancer 27, 29 (1981).

259 Liebert, supra note 142, at 228.

260 Hayward, supra note 3, at 12.

261 Hogshead, supra note 185, at 129.

262 The following checklist was developed for mental use of inclusion on the patient record:

Informed Consent Checklist

  • ( ) side effects discussed

  • ( ) risk/benefit ratio, special considerations

  • ( ) alternative treatments

  • ( ) estimated duration of treatment

  • ( ) need for co-operation and openness

  • ( ) patient's understanding?

  • ( ) questions asked?

  • ( ) patient's verbal agreement

  • ( ) patient anxiety leading to therapeutic privilege

  • ( ) patient waives right to informed consent

Hayward, supra note 3, at 11.

263 Id.

264 Appelbaum & Roth, supra note 12, at 1465.

265 Id. at 1464.

266 Id. at 1466.

267 Kaufmann, Ruth, Lidz & Meisel, supra note 27, at 357. The authors analogize this situation of doubt with that operating in the criminal justice system, where in the case of doubt a presumption of innocence is made in favor of the accused.

Such a finding is consistent with fundamental principles of ethics and human rights since the individual's autonomy is preserved.

268 Dickens, The Role of the Famiy in Surrogate Medical Consent, in Medical Ethics and Human Life: Doctor, Patient, and Family in the New Technology 87, 89 (J.E. Thomas ed. 1983).

269 Id.

270 Faden, supra note 178, at 278.

271 G. Caplan, supra note 5, at 40.

272 N. Hansell, supra note 6, at 15-16. See also L.A. HOFF, supra note 5, at 34-36.

273 See supra notes 185-187.

274 See supra notes 172-184 and accompanying text.