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Placebo Therapy and the Law: Prescribe With Care

Published online by Cambridge University Press:  29 April 2021

Marshall B. Kapp
Marshall B. Kapp*
Affiliation:
Department of Medicine in Society, Wright State University; Johns Hopkins University, George Washington University, Harvard University
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Abstract

The use of placebos by physicians for therapeutic purposes is a common part of clinical medical practice. This Article examines the legal and ethical ramifications of placebo prescription. In particular, ethical concerns are related to substantive legal theories that may be advanced to attack or defend the practice of placebo therapy in particular cases. The author concludes that, under certain strictly denned circumstances, the use of placebos in patient care is ethically and legally justifiable. However, from any perspective, the rights and duties inherent in the physician-patient relationship must be respected by the physician when considering the clinical use of placebos.

Type
Articles
Information
American Journal of Law & Medicine , Volume 8 , Issue 4 , Winter 1983 , pp. 371 - 405
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1983

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References

1 Shapiro, The Placebo Response, in Modern Perspectives in World Psychiatry 597 (J. Howells ed. 1971).

2 Rhein, Placebo: Deception or Patient Therapy?, Med. World News, Feb. 4, 1980, at 39

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4 T. Percival, Percival's Medical Ethics (1803) (reprints ed. by C.D. Leake 1975).

5 Lasagna, Drugs in Modern Medicine, in Triumphs of Medicine 177 (H. Keen, J. Jarrett & A. Levy eds. 1976).

6 See, e.g., Bok, The Ethics of Giving Placebos, 231 Sci. Am. 17 (Nov. 1974).

7 Brody, , The Lie That Heals: The Ethics of Giving Placebos, 97 Annals Internal Med. 112, 114 (1982)Google Scholar (stating, without any support, that in recent times the fear of lawsuits may have played a role in reducing the rate of placebo therapy); Grad, , Medical Ethics and the Law, 437 Annals 19, 24 (1978)Google Scholar (simply noting that the ethical questions involved may have legal implications).

8 This Article deals only with the prescribing of placebos for the purpose of therapeutically benefiting a particular patient. The extensive use of placebos in research is beyond its scope.

The phenomenon of the placebo effect is widespread and powerful enough that no research trials of new medications or surgical procedures are considered truly rigorous unless the element of suggestion has been effectively eliminated through the use of randomized double-blind studies. Federal regulations governing New Drug Applications (NDAs) require as part of the data that must be submitted for approval a comparison of results of the use of a new drug with an inactive preparation designed to resemble the test drug as far as possible. 21 C.F.R. § 314.111 (a)(5)(ii)(a)(4)(ii) (1981).

Since placebos are used in research situations for very different purposes than in the therapeutic setting, the legal and ethical issues involved are also different. For instance, the researcher rarely needs to engage in deception, since subjects are ordinarily informed that they will be participating in a double blind trial during which they may be given placebos. However, for an example of the egregious misuse of placebos in research, see J.H.Jones, Bad Blood 147-48 (1981) (syphilis sufferers being studied were all told they were receiving active treatment, when in fact none were). For general discussions of issues raised by the use of placebos in research, see Gibson, J., Medication Law and Behavior 276, 279 (1976)Google Scholar; Kieffer, G., Bioethics: A Textbook of Issues 246 (1979)Google Scholar; R. Levine, Ethics and Regulation of Clinical Research 151-52 (1981); R. Veatch, Case Studies in Medical Ethics 301-02 (1977).

The scope of this Article is also limited to those situations in which the physician expects that the treatment prescribed will not be pharmacologically effective. Thus, excluded from discussion are the many treatments in which physicians hold misplaced faith.

9 Hooper's Medical Dictionary (1811), quoted in Hackler, , Medicine's Magic Pill, 26 United Mainliner Mag. 86 (1982)Google Scholar.

10 Shapiro, supra note 1, at 599. Dr. Shapiro has also supplied a more succinct version of this definition: “Any therapeutic procedure (or that component of any therapeutic procedure) which is objectively without specific activity for the condition being treated.” Shapiro, , The Placebo Effect in the History of Medical Treatment: Implications for Psychiatry, 116 Am. J. Psychiatry 298 (1959)Google Scholar.

Another commentator has defined the placebo effect as “any change in a patient's condition attributable to a pill, potion or procedure (but not due to its specific pharmacodynamic properties) which derives from the significance the patient attaches to the whole therapeutic effort.” Simmons, , Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos, 4 J. Med. Ethics 172 (1978)Google Scholar.

The judiciary, in the only reported decision discovered that offered a definition, delineated a placebo as “a medicine or preparation, especially an inactive one, given merely to satisfy a patient.” Delgrandhile v. Hotz, 204 So. 2d 73, 74 (La. Ct. App. 1967).

11 See Preston, T., The Clay Pedestal: A Re-Examination of the Doctor-Patient Relationship 162 (1981)Google Scholar.

Over-the-counter drugs (OTC) act mainly as placebos, despite the fact that some of them contain ingredients that have clearly defined pharmacological effects. First, it is generally proposed that even for currently available OTC drugs with some known actions, the predominant effect is likely to be that of a placebo. Second, it is contended that the remainder of OTCs, for which specific actions are still to be determined, behave primarily as placebos, making assessment of their true value difficult.

Jones, Do Over-the-Counter Drugs Act Mainly As Placebos? Yes, in Controversies in Therapeutics 26 (L. Lasagna ed. 1980). This position is attacked in Pisani, Are Most Over-The-Counter Medicines Really Placebos? Definitely Not, in Controversies in Therapeutics 33 (L. Lasagna ed. 1980).

13 See Beecher, , Surgery As Placebo, 176 J. A.M.A. 1102 (1961)Google Scholar; Corkin, A Prospective Study of Cingulotomy, in The Psychosurgery Debate: Scientific, Legal, and Ethical Perspectives 164, 197-200 (E. Valenstein ed. 1980) (psychosurgery as placebo); Randal, , Coronary Artery Bypass Surgery, 12 Hastings Center Rep. 13, 16 (1982)Google Scholar (heart surgery as placebo); Valenstein, Review of the Literature on Postoperative Evaluation, in The Psychosurgery Debate: Scientific, Legal, and Ethical Perspectives 141, 152-54 (E. Valenstein ed. 1980) (psychosurgery as placebo).

14 See generally M. Jospe, The Placebo Effect in Healing (1978) (extensive treatment of the history, characteristics, and effects of placebos); Brody, supra note 7, at 112-13 (history of placebo use and placebo research); Shapiro, , A Contribution to a History of the Placebo Effect, 5 Behav. Sci. 109 (1960)Google Scholar (history of conscious invocation of the placebo effect).

15 J. Laprata, supra note 3, at 87.

16 Bok, supra note 6, at 18. Bok suggests that the use of placebos is much more widespread than most people realize. Its use occurs increasingly in diagnosis and therapy “as more and more people seek and receive medical care and as their desire for instant, push-button alleviation of symptoms is stimulated by drug advertising and by rising expectations of what 'science’ can do.” See also Simmons, supra note 10, at 173 (estimating a placebo use rate of thirty to forty-five percent).

17 Lowinger, & Dobie, , What Makes the Placebo Work?, 20 Archives Gen. Psychiatry 84 (1969)Google Scholar.

18 Hackler, supra note 9, at 86.

19 McKean, Closing In On the Herpes Virus, 2 Discover Mag. 75, 77 (1981). See also A. Duncan, G. Dunstan & R. Welbourn Eds., Dictionary of Medical Ethics 329 (revised and enlarged ed. 1981) [hereinafter cited as Dictionary] (placebo effect achieved in one-third of patients); G. Kieffer, supra note 8, at 287 (forty percent effect in drug usefulness tests); F.J. Evans, The Power of a Sugar Pill, 7 Psychology Today 54 No. 11 (April 1974) (fifty percent).

20 See, e.g., Gudjonsson and Spira, What Is the Best Antacid? in Controversies in Therapeutics 204, 207-13 (L. Lasagna ed. 1980) (use of placebos to treat several forms of ulcer).

21 Katz, J., Experimentation with Human Beings 685 (1972)Google Scholar.

22 Lipkin, M., Straight Talk About your Health Care 77 (1977)Google Scholar.

23 See generally H. Brody, Placebos and the Philosophy of Medicine: Clinical, Conceptual, and Ethical Issues 18-24 (1980) (regarding theories of the placebo mechanism).

24 Jones, supra note 12, at 30.

25 Regarding endorphins and their possible link to the placebo response, see generally E. Costa & M. Trabucchi, The Endorphins (1978), D. Jaffe, Health from within 56 (1980); E. Maggio, The Psychiatry-Law Dilemma: Mental Health Versus Human Rights 180 (1981); Levine, , Gordon, , & Fields, , The Mechanism ofPlacebo Analgesia, 8091 Lancet 654 (1978)Google Scholar.

26 H. Brody, Ethical Decisions in Medicine 52 (2d ed. 1981).

27 See Bok, supra note 6, at 19 (the success of the placebo is presumed to depend specifically on the patient's ignorance and suggestibility). But see note 192, infra and accompanying text for proposition that deception is not necessary.

28 Evans, supra note 19, at 56.

29 See Munson, R., Intervention and Reflection: Basic Issues in Medical Ethics 174 (1979)Google Scholar (arguing that lying outright is the most likely way for the physician to achieve a placebo effect); Bok, supra note 6, at 19.

30 See Beauchamp, T. & Childress, J., Principles of Biomedical Ethics 33, 46, 74(1979)Google Scholar; H. Brody, supra note 23, at 105; Haring, B., Ethics of Manipulation: Issues in Medicine, Behavior Control and Genetics 89 (1975)Google Scholar.

31 J. Fletcher, Morals and Medicine 51-52 (1954).

32 See B.F. Fuller & F. Fuller, Physician or Magician 120(1978); Brody, supra note 7, at 113-14.

33 See Veatch, , The Ethics of Dispensing Placebos, 5 U. S. Pharmacist 70, 71 (1980)Google Scholar.

34 Lipp, M., Respectful Treatment: The Human Side of Medical Care 79 (1977)Google Scholar; Brody, supra note 7, at 117.

35 Cabot, R., Social Service and the Art of Healing 133 (1909)Google Scholar.

36 See infra notes 96-104 and accompanying text.

37 J. Fletcher, supra note 31, at 51-52.

38 T . Preston, supra note 11, at 163.

39 Pratt, Reshaping the Consumer's Posture in Health Care, in The Doctor-Patient Relationship in the Changing Health Scene 197, 210 (E. Gallagher ed. 1978) (DHEW Pub. No. (NIH) 78-183).

40 Veatch, supra note 33, at 71.

41 Bok, supra note 6, at 2 1 .

42 Grad, supra note 7, at 24.

43 B.F. Fuller & F. Fuller, supra note 32, at 120.

44 Purtilo, R. & Cassel, C., Ethical Dimensions in the Health Professions 121 (1981)Google Scholar.

45 B. F. Fuller & F. Fuller, supra note 32, at 120.

46 See, e.g., Annas, , The Emerging Stowaway: Patients’ Rights in the 1980s, 10 Law, Med. and Health Care 32 (1982)Google Scholar.

47 See Rennie, , Informed Consent by ‘Well-Nigh Abject’ Adults, 302 New Eng. J. Med. 916 (1980)Google Scholar.

48 See, e.g., Home v. Patton, 291 Ala. 701, 287 So. 2d 824 (1974); Weiss, , Confidentiality Expectations of Patients, Physicians, and Medical Students, 247 J. A.M.A. 2695, 2696 (1982)Google Scholar; Note, Privacy in Personal Medical Information: A Diagnosis, 33 U. FLA. L. Rev. 394 (1981).

49 T. Beauchamp & J. Childress, supra note 30, at 205.

50 R. Munson, supra note 29, at 200.

51 Stedman's Medical Dictionary 647 (4th lawyer's ed. 1976).

52 See supra note 22 and accompanying text.

53 Benson, H., The Mind-Body Effect 22, 22-44 (1979)Google Scholar.

54 The Humble Humbug, 267 Lancet 321 (1954); Leslie, , Ethics and Practice of Placebo Therapy, 16 Am. J. Med. 854, 859 (1954)Google Scholar.

55 Leslie, , Ethics and Practice of Placebo Therapy, 16 Am. J. Med. 854, 859 (1954)Google Scholar.

56 See B. Haring, supra note 30, at 89; Veatch, supra note 33, at 7 1 .

57 Salfield, , The Placebo, 265 Lancet 940 (1953)Google Scholar.

58 J. Fletcher, supra note 31 , at 52.

59 T. Preston, supra note 11, at 163-64.

60 J. Fletcher, supra note 31, at 52.

61 Brody, supra note 7, at 116 (quoting Richard Cabot).

62 See Bok, supra note 6, at 20; Veatch, supra note 33, at 71.

63 See K. Lasko, The Great Billion Dollar Medical Swindle 61-62, 171, (1980) (referring to regular Vitamin B12 injections); Stroman, D., The Medical Establishment and Social Responsibility 65 (1976)Google Scholar.

64 H. Brody, supra note 23, at 105. See also R. Veatch, supra note 8, at 151-53.

65 H. Brody, supra note 23, at 105.

66 See Grad, supra note 7, at 24. See also infra notes 119-124 and accompanying text (legal issue of defrauding third-party payors).

67 See generally J. Rawls, A Theory of Justice (1971).

68 The Humble Humbug, 267 Lancet 321 (1954)Google Scholar.

69 Goodwin, , Goodwin, & and Vogel, , Knowledge and Use of Placebos By House Officers and Nurses, 91 Annals Internal Med. 106, 109 (1979)Google Scholar.

70 See id.

71 Barnlund, The Mystification of Meaning: Doctor-Patient Encounters, 51 J. Med. Ed. 716, (September 1976). See also Cousins, , The Physician as Communicator, 248 J. A.M.A. 587 (1982)Google Scholar.

72 Illich, I., Medical Nemesis 108 (1976)Google Scholar.

73 A. Malleson, The Medical Runaround 29-30 (1973).

74 Hackler, supra note 9, at 87.

75 See supra note 16 and accompanying text for estimated incidence rates.

76 Brody, supra note 7, at 115 (quoting A. Leslie, Ethics and the Practice of Placebo Therapy, 16 Am. J. Med. 854-62 (1954)).

77 J. Lapatra, supra note 3, at 86.

78 H. Brody, supra note 23, at 97.

79 But see Brody, supra note 7, at 116 (criticizing the crude risk/benefit analysis that contents most advocates of this view).

80 F.J. Evans, supra note 19, at 59.

81 Halleck, S., Law in the Practice of Psychiatry: A Handbook for Clinicians 29 (1980)CrossRefGoogle Scholar.

82 See R. Munson, supra note 29, at 174.

83 See H. Brody, supra note 26, at 52 (quoting physicians); Evans, supra note 19, at 59.

84 See J. Lapatra, supra note 3, at 90.

85 See Rhein, supra note 2, at 39; Lasagna, supra note 5, at 179-80; Hackler, supra note 9, at 87.

86 T. Beauchamp & J. Childress, supra note 30, at 254-55.

87 Leslie, supra note 55, at 856.

88 Plato, The Republic 86 (B. Jowlett trans. 1941).

89 Fuchs, V., Who Shall Live? Health, Economics, and Social Change 125 (1974)Google Scholar.

90 But see Pratt, supra note 39, at 210 (questioning the accuracy of this model of the physician-patient relationship).

91 H. Brody, supra note 23, at 108 (emphasis in original).

92 R. Veatch, Death, Dying, and the Biological Revolution, Chap. 6 (1976). Compare with Veatch's later statement that placebos are morally acceptable if, but only if, the patient has somehow consented to be deceived, Veatch, R., A Theory of Medical Ethics 221 (1981)Google Scholar.

93 T. Beauchamp & J. Childress, supra note 30, at 208.

94 Cross, & Churchill, , Ethical and Cultural Dimensions of Informed Consent, 96 Annals Internal Med. 110, 112 (1982)Google Scholar.

95 Placebo Therapy, 192 Practitioner 590 (1964)Google Scholar.

96 See Brody, , The Patient's Role in Clinical Decision-Making, 93 Annals Internal Med. 718, 719 (1980)Google Scholar.

97 Privacy Act, 5 U.S.C. § 552a (1977).

98 See, e.g., Colo. Rev. Stat. 25-1-801 (1976); Ill. Stat. Ann. ch. 51, sec. 71 (Smith-Hurd Supp. 1980); Friedman, , Confidentiality — State Laws Redefine Records Accessibility, 10 Hosp. Med. Staff 2 (1981)Google Scholar.

99 See, e.g., Rabens v. Jackson Park Hosp. Found., 40 Ill. App. 3d 113, 351 N.E.2d 276 (1976); Hutchins v. Texas Rehabilitation Comm., 544 S.W.2d 802 (Tex. Civ. App. 1976). Compare Michael, & Bordley, , Do Patients Want Access to Their Medical Records? 20 Med. Care 432 (1982)Google Scholar (patient access to the medical record has a demonstrated salutary effect on patient satisfaction and the physician-patient relationship) with Altman, , Reich, , Kelly, , & Rogers, , Patients Who Read Their Hospital Charts, 302 New Eng. J. Med. 169 (1980)Google Scholar (record requests are symptomatic of mistrust and sometimes expressions of adversary physician-patient relations).

100 See Hamilton, P., Health Care Comsumerism 53 (1982)Google Scholar. Much of the impetus for second opinions also stems from a rising cost consciousness, as many insurers and companies are now requesting, or demanding, that insureds or employees get a second medical opinion before undergoing certain types of procedures, especially surgery. See, e.g., Millenson, Once a Bargain, Now Health Care Costs Staggering, Dayton Daily News, Aug. 22, 1982, at 5B.

101 See Vogel, & Delgado, , To Tell the Truth: Physicians’ Duty to Disclose Medical Mistakes, 28 U.C.L.A. L. Rev. 52, 53 (1980)Google Scholar.

102 See supra note 41-42 and accompanying text.

103 See R. Purtilo, supra note 44, at 122-23.

104 Cf. Fox, , Medical and Prescription Records — Patient Access and Confidentiality, 4 U.S. Pharmacist 15, 16 (1979)Google Scholar (discussing the right of patients to have access to the information contained in their prescriptions). Since most legislative actions have focused specifically on the medical profession, often these statutes are silent on the question of whether prescriptions fall within the category of “patient records,” and whether pharmacists have “patient's records” in their custody.

105 Halligan, , The Standard of Disclosure by Physicians to Patients: Competing Models of Informed Consent, 41 La. L. Rev. 9, 25 (1980)Google Scholar.

106 Id. at 26; See also F. Harper & F. James, The Law of Torts § 7 (1956); W. Prosser, Handbook of the Law of Torts § 106 (4th ed. 1971); Lopez v. Swyer, 115 N.J. Super. 237, 279 A.2d 116 (1971), modified on other grounds 62 N.J. 267, 300, A.2d 563 (1973).

107 Perkins v. First Nat'l Bank of Atlanta, 221 Ga. 82, 95, 143 S.E.2d 474, 4 8 4 (1965) (quoting Brown v. Brown, 209 Ga. 620, 621 , 75 S.E.2d 13, 17 (1953)).

108 Lopez, 115 N.J. Super, at 237, 279 A.2d at 116; Halligan, supra note 105, at 26; LeBlang, , Disclosure of Injury and Illness: Responsibilities in the Physician-Patient Relationship, 9 L. Med. & Health Care 4 (1981)Google Scholar.

109 Halligan, supra note 105, at 28. Nevertheless, proving the requisite intent that the physician knew at the time that he recommended it that the treatment could have no reasonable medical justification may be quite problematic, especially where the placebo consists of more than a mere inert substance. See A. Holder, Medical Malpractice Law 282-83 (2d ed. 1975).

110 Halligan, supra note 105, at 27-28. Cf. Green v. Hale, 433 F.2d 324 (5th Cir. 1970) (exemplary damages awarded against a physician for fraud where the physician concealed information from an infant's parents that he was not authorized to admit and treat persons in the local hospital, when such authorization appeared critical to the well-being of the child); McClellan, , Informed Consent to Medical Therapy and Experimentation: The Case for Invoking Punitive Damages to Deter Impingement of Individual Autonomy, 3 J. Legal Med. 81 (1982)Google Scholar.

111 See Vogel & Delgado, supra note 101, at 68 n.94.

112 401 S.W.2d 954 (Mo. App. 1966).

113 Id. at 959.

114 453 S.W.3d 595 (Mo. App. 1976).

115 Id. at 600.

116 125 Cal. App. 3d 623, 178 Cal. Rptr. 167 (1981).

117 See Sommerville, M., Consent to Medical Care 56 (1979)Google Scholar (a Study Paper prepared for the Law Reform Commission of Canada).

118 See, e.g., Ohio Rev. Code Ann. § 4731.22 (B)(9) (Supp. 1981) (state medical board may “limit, reprimand, revoke, suspend, place on probation, or refuse to register or reinstate” a medical license if a practitioner engages in “[t]he obtaining of, or attempting to obtain, money or anything of value by fraudulent misrepresentations in the course of treatment”).

119 The major private third-party funding sources for health care are Blue Cross, Blue Shield, and a variety of smaller private insurers. See V. FUCHS, supra note 89, at 127-42. Prepaid health plans, such as Health Maintenance Organizations (HMOs), see generally Iglehart, , The Future of HMOs, 307 New Eng. J. Med. 451 (1982)Google Scholar, would presumably not be affected by this issue, since they do not reimburse providers or suppliers on a fee-for-service or fee-for-goods basis.

120 The major publicly financed health programs are Medicare, Social Security Act, 42 U.S.C. § 1395 (1976 & Supp. IV 1980); Medicaid, Social Security Act, 42 U.S.C. § 1396 (1976 & Supp. IV 1980); and CHAMPUS, 10 U.S.C. §§ 1071-1089 (1976 & Supp. V 1981).

121 See U.S. Dept. of Health, Education, and Welfare, The Secretary's National Conference on Fraud, Abuse and Error: Protecting the Taxpayer's Dollar (1979); U.S. General Accounting Office, Federal Agencies Can, and Should, Do More to Combat Fraud in Government Programs (1978).

122 See Smith, D., Long-Term Care in Transition: The Regulation of Nursing Homes 104, 112 (1981)Google Scholar; Cohen & Kapp, Regulations Implementing the Anti-Fraud and Abuse Amendments, in Long Term Care and the Law 149 (J. Skiba ed. 1979); Comment, Physician Fraud in the Medicare-Medicaid Programs — Kickbacks, Bribes, and Remunerations, 10 Mem. ST. U. L. Rev. 684 (1980)Google Scholar; Pies, , Control of Fraud and Abuse in Medicare and Medicaid, 3 Am. J. L. & Med. 323, 328-30 (1977)Google Scholar.

123 See supra notes 62-66 and accompanying text.

124 See Pear, 1981 Spending for Health Care Is Up by 15.1, N.Y. Times, July 27, 1982, at 1, col.5.

125 Grad, supra note 7, at 24.

126 See Simmons, supra note 10, at 179.

127 See Vogel & Delgado, supra note 101, at 70.

128 Vogel & Delgado, supra note 101, at 69 (quoting Cobbs v. Grant, 8 Cal. 3d 229, 242, 502 P.2d 1, 9, 104 Cal. Rptr. 505, 513 (1972)).

129 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert, denied, 409 U.S. 1064 (1972). The literature on the subject of informed consent is voluminous. For general background, see J. King, The Law of Medical Malpractice 136-65 (1977); A. Rosoft, Informed Consent: A Guide for Health Care Providers (1981); Hinkle, , Informed Consent and the Family Physician, 12 J. Fam. Prac. 109 (1981)Google Scholar; Miller, , Informed Consent: I, 244 J. A.M.A. 2100 (1980)Google Scholar.

130 Schloendorff v. Soc'y of N.Y. Hosp., 211 N.Y. 124, 105 N.E. 92 (1914); Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093, rehearing denied, 187 Kan. 186, 354 P.2d 670 (1960); Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972); Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert, denied, 409 U.S. 1064 (1972).

131 See Meisel, & Kabnick, , Informed Consent to Medical Treatment: An Analysis of Recent Legislation, 41 U. Pitt. L. Rev. 407 (1980)Google Scholar.

132 See, e.g., Mental Health Systems Act, 42 U.S.C. § 9501(l)(C) (Supp. IV 1980).

133 American Medical Association, Current Opinions of the Judicial Council (1982), provides, in pertinent part:

Section 8.07 Informed Consent. The patient's right of self-decision can be effectively exercised only if t he patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment.

Section 8.11 Patient Information. The Principles of Medical Ethics require a physician to make relevant information available to patients, colleagues and the public. The physician must properly inform the patient of the nature and purpose of the treatment undertaken or prescribed. The physician may not refuse to so inform [a] patient.

134 The American Hospital Association's Statement on a Patient's Bill of Rights provides: “The patient has the right to receive from his physician information necessary to give informed consent prior to the start of any procedure and/or treatment.” Adopted by the Board of Trustees November 17, 1972, reprinted at 47 Hospitals 41 (1973). See generally G. Annas, The Rights of Hospital Patients 57-58 (1975); Strickler, The Rights of Patients, in Representing Health Care Facilities 1, 2-17 (M. Strickler, F. Ballard eds. 1981).

135 The American Health Care Association's “Patients’ Rights in Long-Term Care Facilities” provides that among the basic rights of long term care residents is “the right to participate in decisions about care and treatment.” AHCA Policy Paper: Patients’ Rights, Am. Health Care A.J., Sept. 1981, at 55, 57-58. See also National Council of Health Centers, Statement of Business Practices for Nursing Facilities 4 (1981).

136 JCAH Standards on “Rights and Responsibilities of Patients” provide:

The patient has the right to reasonably informed participation in decisions involving his health care. To the degree possible, this should be based on a clear, concise explanation of his condition and of all proposed technical procedures, including the possibilities of any risk of mortality or serious side effects, problems related to recuperation, and probability of success. The patient should not be subjected to any procedure without his voluntary, competent, and understanding consent, or that of his legally authorized representative. Where medically significant alternatives for care or treatment exist, the patient shall be so informed.

Joint Commission on Accreditation of Hospitals, Accreditation Manual for Hospitals xiv-xv (1980 ed.). Regarding the legal significance of these standards, see generally Dornette, , The Legal Impact on Voluntary Standards in Civil Actions Against the Health Care Provider, 2 N.Y.L. Sch. L. Rev. 925 (1977)Google Scholar.

137 Ohio Rev. Code Ann. § 2317.54 (Page 1981) (fraudulent misrepresentation of material facts vitiates the patient's consent to a surgical or medical procedure); M. Sommerville, supra note 117, at 56.

138 Fausette v. Grim, 186 S.W. 1177, 1181 (Mo. 1916). The court also added in dicta that “[i]n such case [where the consent was obtained by a fraudulent representation the physician] would perhaps be liable to an action for deceit.” Cf. supra notes 112-16 and accompanying text.

139 See, e.g., Hamilton v. Hardy, 37 Colo. App. 375, 549 P.2d 1099 (1976); Inform the Patient, 211 J. A.M.A. 654 (1970)Google Scholar. See also Kapp, , Prescribing Approved Drugs for Nonapproved Uses: Physicians’ Disclosure Obligations to Their Patients, 9 Law, Med. and Health Care 20 (1981)Google Scholar (arguing for physician's duty to disclose to the patient the unapproved status of a drug for the particular use for which it is being prescribed).

140 See generally Halligan, supra note 105.

141 Wooley v. Henderson, 418 A.2d 1123‘(Me. 1980); Scott v. Wilson, 396 S.W.2d 532 (Tex. Civ. App. 1965); A. Rosoff, supra note 129, at 34-38; Miller, supra note 129, at 2101.

142 See, e.g., Gates v. Jensen, 92 Wash. 2d 246, 595 P.2d 919 (1979); Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974); see also Hirsh, , Judicially Imposed Standard of Care — Prophecy in Medicine, 21 Med. Trial Tech. Q. 1 (1980)Google Scholar; Meisel, , The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent, 56 Neb. L. Rev. 51 (1977)Google Scholar.

143 Riedinger v. Colburn, 361 F. Supp. 1073 (D. Idaho 1973); Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert, denied, 409 U.S. 1064 (1972); Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972); A. Rosoff, supra note 129, at 38-41; Miller, supra note 129, at 2101-03.

144 Trichter, , Informed Consent: The Patient as Individual, 15 Forum 455 (1980)Google Scholar. See also Trichter, & Lewis, , Informed Consent: The Three Tests and a Modest Proposal for the Reality of the Patient as an Individual, 21 S. Tex. L.J. 155 (1981)Google Scholar (arguing for a subjective informed consent test of materiality based on the perspective of the individual, rather than the “reasonable” patient).

145 Shapiro, S. A., Limiting Physician Freedom to Prescribe a Drug for Any Purpose: The Need for FDA Regulation, 73 Nw. U.L. Rev. 801, 832-35 (1979)Google Scholar.

146 See generally J. King, supra note 129.

147 See supra notes 21-22 and accompanying text.

148 See, e.g., Morse v. Hardinger, 34 111. App. 3d 1020, 341 N.E.2d 172 (1976).

149 W. Prosser, supra note 106, at 348.

150 Cf. Vogel & Delgado supra note 101, at 58 (arguing for the physician's duty to disclose erroneous acts or omissions to the patient).

151 Simmons, supra note 10, at 177.

152 See generally Note, Contractual Liability of Physicians: The Interface of Tort and Contract, 28 Buffalo L. Rev. 625 (1979). See also Chapman, , Quiz: Implied Contracts Lead to Malpractice Suits, 22 Physician's Mgmt. 87 (1982)Google Scholar; Feldman, & Ward, , Psychotherapeutic Injury: Reshaping the Implied Contract as an Alternative to Malpractice, 58 N.C.L. Rev. 63 (1979)Google Scholar.

153 See Taylor v. Baptist Memorial Center, 400 So. 2d 369 (Ala. 1981) (even in absence of physical injury, patient could recover damages on her claim as a result of the mental anguish she suffered from the physician's negligence); Hirsh, Legal Problems Facing the'Internist, 3 Forum on Med. 603-04 (1980) (discussing the emerging tort of “outrage”); Stevens, , Negligent Infliction of Emotional Distress by Physicians and Hospitals, 28 Med. Trialtech. Q. 233 (1982)Google Scholar.

154 Halligan, supra note 105, at 51-54, 63-64. Halligan would set the legal standard based on the acts of those physicians “who value patient self-determination,” or “that segment of the medical community that values opportunities for choice by patients.” He fails to elucidate how such physicians are to be identified and distinguished from all the others.

155 See supra note 142 and accompanying text.

156 Peters, , The Application of Reasonable Prudence to Medical Malpractice Litigation: The Precursor to Strict Liability? 9 Law, Med. and Health Care 21 (1981)Google Scholar.

157 See supra notes 82-88 and accompanying text.

158 See supra note 27.

159 R. Perkins, Criminal Law 847-51 (1957); 1 C. Torcia, Wharton's Criminal Law 409-414 (14th ed. 1978). But see Somerville, , Structuring the Issues in Informed Consent, 26 McGill L.J. 741, 770 (1981)Google Scholar (doctrine of therapeutic privilege may not exactly be a particular example of the defense of necessity, but even if it is not, it does have in common the same underlying principle).

160 W. Prosser, supra note 106, at 124-27.

161 See Cornfeldt v. Tongen, 262 N.W.2d 684 (Minn. 1977); Natanson v. Kline, 186 Kan. 393, 406, 350 P.2d 1093, 1097 (1960); J. King, supra note 129, at 164; Vogel & Delgado, supra note 101, at 82.

162 W. Prosser, supra note 106, at 124-27; C. Torcia, supra note 159, at 409-14.

163 See G. Annas, The Rights of Hospital Patients 67-68 (1975), and cases cited therein.

164 In Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (I960), cancer was found to satisfy this requirement. The continuing vitality of that holding in light of modern medical advances in oncology is highly questionable.

165 Vogel & Delgado, supra note 101, at 82.

166 G. Annas, supra note 163, at 68. See also Somerville, supra note 158, at 768 (physician should be required to disclose information to the patient and then placate and explain in order to avoid adverse effects of disclosure, rather than be permitted to avoid a dialogue that may cause anxiety to the patient and, not incidentally, to the physician as well).

167 G. Annas, supra note 163, at 68. See also Somerville, supra note 159, at 768.

168 Simmons, supra note 10, at 174.

169 Hinkle, supra note 129, at 112.

170 See, e.g., Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (Cal. 1972).

171 Somerville, supra note 159, at 767.

172 Haggerty, and Roghmann, , Non-Compliance and Self-Medication, 19 Pediatric Clinics N. Am. 101, 102 (1972)Google Scholar.

173 See, e.g., Schliesman v. Fisher, 158 Cal. Rptr. 527 (Cal. App. 1979).

174 See 7 C.J.S. Assumption (1980).

175 H. Brody, supra note 23, at 101.

176 Id. at 100-02. See also J. Lapatra, supra note 3, at 91; Brody, supra note 7, at 117-18. 177 See Bush, , The Placebo Effect, 14 J. Am. Pharmaceutical A. 671 (1974)Google Scholar. Psychiatrist Jerome Frank calls the patient's positive expectations and beliefs in the physician's healing power, which throughout the history of medicine has been the major cause of curing, “the power of expectant faith.” D. Jaffe, supra note 25, at 53.

178 D. Jaffe, supra note 25, at 54-63.

179 Id., at 62-63.

180 Hackler, supra note 9, at 87.

181 Bok, supra note 6, at 22. Regarding these limitations, see id. See also H. Brody, supra note 26, at 52.

182 See Dictionary, supra note 19, at 330; Simmons, supra note 10, at 179.

183 See Dictionary, supra note 19, at 330; Goodwin, Goodwin, and Vogel,supra note 69, at 110; Bok, supra note 6, at 22.

184 See Dictionary, supra note 19, at 330; Bok, supra note 6, at 22.

185 J. Lapatra, supra note 3, at 89.

186 Legal Ease: Placebos Without Orders, 2 Nursing Life 9 (1982).

187 Bok, supra note 6, at 22.

188 Id.

189 B. Haring, supra note 30, at 89; see also M. Lipp, supra note 34, at 79; Simmons, supra note 10, at 179.

190 B. Haring, supra note 30, at 89; see also M. Lipp, supra note 34, at 79; Simmons, supra note 10, at 179.

191 Rhein, supra note 2, at 47 quoting Goodwin, Goodwin & Vogel (unpublished manuscript).

192 Park, and Covi, , Nonblind Placebo Trial: An Exploration of Neurotic Patients’ Responses to Placebo When Its Inert Content Is Disclosed, 12 Archives Gen. Psychiatry 336 (1965)Google Scholar. See also Lasagna, supra note 5, at 177-78; Veatch, Three Theories of Informed Consent: Philosophical Foundations and Policy Implications, in Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Appendix Vol. 2, at 26-48—26-49 (DHEW Pub. No. (OS) 78-0014)(1978).

193 M. Lipp, supra note 34, at 79.

194 This Article really presents a new application — to placebo therapy — of a theory developed in Comment, When the Truth Can Hurt: Patient-Mediated Informed Consent in Cancer Therapy, 9 U.C.La.-Alaska L. Rev. 143 (1980)Google Scholar, and applied there to the issue of truth-telling with cancer patients.

195 See Lowinger & Dobie, supra note 17, at 88.

196 See R. Veatch, A Theory of Medical Ethics 218 (1981).

197 Comment, supra note 194, at 188.

198 Id., at 189-95. Compare the thesis of this Comment (patient-mediated interaction as a means of resolving t h e dilemma of truth-telling to cancer patients) with that of Stevens, Medical Malpractice: Some Implications of Contract and Arbitration in HMOs, 59 Milbank Memorial Fund QvHealth and Soc'y 59 (1981) (suggesting a system in organized health delivery settings of structuring the provider/patient relationship by a series of explicit contractual provisions covering performance standards, formal grievance procedures, and arbitration).

199 It is interesting to compare this approach to that expounded in R. Burt, Taking Care of Strangers 126-36 (1979) (informed consent should be treated as an ongoing dialogue between the physician and patient, rather than as a certain magic moment when patient permission is all-at-once deemed adequate).

200 See Brody, supra note 7, at 116-17.

201 Norman Cousins quoted in D. Jaffe, supra note 25, at 52.