Hostname: page-component-586b7cd67f-2plfb Total loading time: 0 Render date: 2024-11-22T06:17:11.992Z Has data issue: false hasContentIssue false

Truce on the Battlefield: A Proposal for a Different Approach to Medical Informed Consent

Published online by Cambridge University Press:  01 January 2021

Extract

What is informed consent in medicine? For more than a generation, this deceptively simple question has vexed the law, discomfited medicine, and generated much inspired, provocative, and even contentious commentary.

The question has also spawned several lawsuits. On one side stand patients who claim that, at the time of consent, they were ignorant of a particular risk; who state that, with more or different information, they would have chosen a different treatment; and who argue that, because of an adverse outcome, they now deserve remuneration. On the other side, doctors uneasily watch the lengthening list of suits. Some, troubled by the law's expectations, have reacted by variously describing informed consent as a myth, a fiction, an unattainable goal, or a snare to entrap physicians. They point to the legal commentary condemning informed consent law as ill-defined, diffuse, and fraught with inconsistency, hazy at its best and virtually indecipherable to physicians at its worst: and lacking a fair standard to determine when a patient has sufficient knowledge to give effective consent.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 1994

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Sprang, C. and Winkle, B., “Informed Consent in Theory and Practice: Legal and Medical Perspective on the Informed Consent Doctrine and a Proposed Reconceptualization,” Critical Care Medicine, 17 (1989): 1346–54; and Shugrue, R. and Linstromberg, K., “The Practitioner's Guide to Informed Consent,” Defense Law Journal, 41 (1992): 73-125.CrossRefGoogle Scholar
Schneyer, T., “Informed Consent and the Danger of Bias in the Formation of Medical Disclosure Practices,” Wisconsin Law Review, 1976 (1976): 124–70; and Shugrue, and Linstromberg, , supra note 1, at 82.Google Scholar
Schneyer, , supra note 2, at 147–48.Google Scholar
Sprung, and Winkle, , supra note 1, at 1346; Beecher, H., “Consent in Clinical Experimentation–Myth and Reality,” Journal of the American Medical Association, 195 (1966): 3435; Laforet, E., “The Fiction of Informed Consent,” Journal of the American Medical Association, 235 (1976): 1579-85; and Wettstein, R., “Tardive Dyskinesia and Malpractice,” Behavioral Sciences and the Law, 1 (1983): 85-105.Google Scholar
Maldonado, J., “Strict Liability and Informed Consent: “Don't Say I Didn't Tell You So!”,” Akron Law Review, 9 (1976): 609–28.Google Scholar
Note, “Malpractice: Toward a Viable Disclosure Standard for Informed Consent,” Oklahoma Law Review, 32(1979): 868–90.Google Scholar
Merz, J. and Fischhoff, B., “Informed Consent Does Not Mean Rational Consent: Cognitive Limitations of Decision-Making,” Journal of Legal Medicine, 11 (1990): 321–50; and Note, “Informed Consent–A Proposed Standard for Medical Disclosure,” New York University Law Review, 48 (1973): 548-63.CrossRefGoogle Scholar
Shugrue, and Linstromberg, , supra note 1, at 7980; and Waltz, J. and Scheuneman, T., “Informed Consent to Therapy,” Northwestern University Law Review, 64 (1970): 628–50.Google Scholar
Merz, J., “On a Decision-Making Paradigm of Medical Informed Consent,” Journal of Legal Medicine, 14 (1993): 231–64.CrossRefGoogle Scholar
Tennenhouse, D., “Symposium on Medicolegal Problems in Ophthalmology: Common Misconceptions,” Ophthalmology (Rochester), 86 (1979): 1225–27.CrossRefGoogle Scholar
Shugrue, and Linstromberg, , supra note 1, at 77.Google Scholar
Rosoff, A., Informed Consent: A Guide for Health-Care Practitioners (Rockville: Aspen, 1981), at 33.Google Scholar
Shugrue, and Linstromberg, , supra note 1, at 81.Google Scholar
Merz, and Fischhoff, , supra note 7, at 321.Google Scholar
Id. at 322; and Salgo v. Leland Stanford, Jr., University Board of Trustees, 154 Cal. App. 2d 560; 317 P.2d 170 (1957).Google Scholar
Shugrue, and Linstromberg, , supra note 1, at 123; and American College of Legal Medicine, Legal Medicine: Legal Dynamics of Medical Encounters (St. Louis: Mosby Year Book, 2nd ed., 1991), at 222.Google Scholar
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health-Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Informed Consent as Active, Shared Decision-Making (Washington, D.C.: U.S. Government Printing Office, Vol. 1, 1982), at 17; Rosoff, , supra note 12, at 41; Shugrue, and Linstromberg, , supra note 1, at 97; and “Nature and Degree of Risk as Affecting Duty to Inform,” American Jurisprudence 2d, 61 (1981): § 190.Google Scholar
Cooper v. Roberts, 220 Pa. Super. 260, 286 A.2d 647, (1971).Google Scholar
Waltz, J.R. and Scheuneman, T.W., “Informed Consent to Therapy,” Northwestern University Law Review, 64 (1970): 630; and President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. The Law of Informed Consent (Washington, D.C.: U.S. Government Printing Office, Vol. 3, 1982), at 193.Google Scholar
Shugrue, and Linstromberg, , supra note 1; Merz, and Fischhoff, , supra note 15, at 329; and American Jurisprudence 2d, supra note 17, at § 188.Google Scholar
American Jurisprudence 2d, supra note 17, at § 188; and Meyer, M.J., “Patients’ Duties,” Journal of Medicine and Philosophy, 17 (1992): 541–55.CrossRefGoogle Scholar
Gaylin, W. et al., Doing Good: The Limits of Benevolence (New York: Pantheon, 1978), at 8293; and President's Commission, supra note 17, at 34.Google Scholar
Gild, W., “Informed Consent: A Review,” Anesthesia and Analgesia, 68 (1989): at 652.CrossRefGoogle Scholar
Keeton, W. Dobbs, D. Keeton, R. and Owen, D., Prosser and Keeton on the Law of Torts (St. Paul: West Publishing, 5th ed., 1984), at § 32.Google Scholar
Myers, M.J., “Informed Consent in Medical Malpractice,” California Law Review, 55 (1967): at 1405; and Shugrue, and Linstromberg, , supra note 1, at 95.CrossRefGoogle Scholar
Shugrue, and Linstromberg, , supra note 1, at 95; and Katz, J., “Informed Consent–A Fairy Tale? Law's Vision,” University of Pittsburgh Law Review, 39 (1977): at 157.Google Scholar
Rosoff, , supra note 12, at 55.Google Scholar
Shugrue, and Linstromberg, , supra note 1, at 95; American Law Reports 3d, 88 (1978): at 1036; and Myers, , supra note 25, at 1404.Google Scholar
Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1 (1972); and American Law Reports 3d, supra note 28, at 1035.Google Scholar
Bursztain, H. Hamm, R.M. Gutheil, T.S. and Brodsky, A., “The Decision-Analytic Approach to Medical Malpractice Law: Formal Proposals and Informal Syntheses,” Medical Decision Making, 4 (1984): 402–14; and Myers, , supra note 25, at 1404.Google Scholar
Merz, , supra note 9, at 240.Google Scholar
Bursztain, et al., supra note 30.Google Scholar
Note, supra note 6.Google Scholar
Id. at 877.Google Scholar
Schneyer, , supra note 2, at 143.Google Scholar
Cooper v. Roberts, supra note 18.Google Scholar
Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972), 93 S. Ct. 560, 34 L.Ed.2d 518 (1972).Google Scholar
Cooper v. Roberts, supra note 18, at 650.Google Scholar
Canterbury v. Spence, supra note 38, at 786–87.Google Scholar
Merz, , supra note 9, at 251; and Nishi v. Hartwell, 52 Haw. 188, 473 P.2d 116 (1970).Google Scholar
Capron, A.M., “Informed Consent in Catastrophic Disease Research and Treatment,” University of Pennsylvania Law Review, 123 (1974): at 408.CrossRefGoogle Scholar
Epstein, R., “Medical Malpractice: The Case for Contract,” American Bar Foundation Research Journal, 35 (1976): at 121.Google Scholar
McPherson v. Ellis, N.C. 287, S.E.2d 892 (1982).Google Scholar
Cobbs v. Grant, 8 Cal. 3d 229, 502, P.2d 1 (1972).Google Scholar
Getchell v. Mansfield, 260 Or. 174, 489 P.2d 953, 956 (1971).Google Scholar
Precourt v. Frederick, 395 Mass. 689, 481 N.E.2d 1144, 1148 (1985).Google Scholar
Merz, and Fischhoff, , supra note 7, at 333; Schneyer, supra note 2, at 143; and Canterbury v. Spence, supra note 38, at 788.Google Scholar
Mazur, D.J., “Judicial and Legislative Viewpoints on Physician Misestimation of Patient Dysutilities: A Problem for Decision Analysts,” Medical Decision Making, 10 (1990): 172–80; Merz, supra note 9, at 244; and Rozovsky, F.A., Consent to Treatment: A Practical Guide (Boston: Little, Brown, 1984), at 54.CrossRefGoogle Scholar
Merz, and Fischhoff, , supra note 7, at 334.Google Scholar
Gates v. Jensen, 92 Wash. 2d 251, 595 P.2d 919 (1979).Google Scholar
Meeks v. Marx, 15 Wash. App. 578, 550 P.2d 1158 (1976).Google Scholar
Miller v. Kennedy, 11 Wash. App. 272, 522 P.2d 852 (1974).Google Scholar
Harnish v. Children's Hospital Medical Center, 387 Mass. 152, 439 N.E.2d 240 (1982).Google Scholar
Winkjer v. Herr, 277 N.W.2d 579 (N.D. 1979).CrossRefGoogle Scholar
Precourt v. Frederick, supra note 47, at 1148.Google Scholar
Starnes v. Taylor, 272 N.C. 386, 158 S.E.2d 339 (1968).Google Scholar
Tangora v. Matanky, 42 Cal. 348, 231 Cal. App. 2d 468–74 (1964).Google Scholar
Merz, supra note 9, at 245.Google Scholar
Note, supra note 6, at 548; Merz and Fischhoff, supra note 7, at 337; and Merz, supra note 9, at 264.Google Scholar
Merz, supra note 9, at 241.Google Scholar
Nakao, M. and Axelrod, S., “Numbers are Better than Words,” American Journal of Medicine, 74 (1983): 1061–65.CrossRefGoogle Scholar
Shannon, Smith v., 100 Wash. 2d 26, 666 P.2d 351 (1983).CrossRefGoogle Scholar
Shugrue, and Linstromberg, , supra note 1, at 98.Google Scholar
Canterbury v. Spence, supra note 38, at 788.Google Scholar
ZeBarth v. Swedish Hospital Medical Center, 81 Wash. 2d 12, 499 P.2d 1 (1972).Google Scholar
Hartke v. McKelway, 707 F.2d 1544 (D.C. Cir. 1983), cert. denied, 464 U.S. 983, 104 S. Ct. 425, 78 L.Ed. 360 (1983).Google Scholar
Canterbury v. Spence, supra note 38, at 788.Google Scholar
Hondroulis v. Schumacher, 546 So. 2d 466 (La. 1989).Google Scholar
Sprung, and Winick, , supra note 1, at 1348.Google Scholar
Katz, J., The Silent World of Doctor and Patient (New York: The Free Press, 1984), at 82.Google Scholar
President's Commission, supra note 17, at 23.Google Scholar
Katz, , supra note 71, at 82.Google Scholar
President's Commission, supra note 19; Mazurr, D.J., “Why the Goals of Informed Consent are not Realized: Treatise on Informed Consent for the Primary Care Physician,” Journal of General Internal Medicine, 3 (1988): at 371; Merz, and Fischhoff, , supra note 7, at 330; and Pegalis, S.E. and Wachsman, H.F., American Law of Medical Malpractice 2d (Deerfield, Illinois: Clark Boardman Callaghan, 1992), at 196.Google Scholar
Scott v. Bradford, 606 P.2d 554 (Okla. 1979).CrossRefGoogle Scholar
Epstein, , supra note 43, at 124.Google Scholar
Schneyer, , supra note 2, at 146.Google Scholar
McKinney v. Nash, 174 Cal. 642, 12 Cal. App. 3d 428 (1976).Google Scholar
Merz, , supra note 9, at 258.Google Scholar
Woerner, M.G. et al., “The Prevalence of Tardive Dyskinesia,” Journal of Clinical Psychopharmacology, 11 (1991): 3442; Jeste, D.V. and Caligiuri, M.P., “Tardive Dyskinesia,” Schizophrenia Bulletin, 19 (1993): 303-12; and Cavallaro, R. et al., “Tardive Dyskinesia Outcomes: Clinical and Pharmacologic Correlations of Remission and Persistence,” Neuropsychopharmacology, 8 (1993): 233-39.CrossRefGoogle Scholar
Glazer, W.M. et al., “Predicting the Long-Term Risk of Tardive Dyskinesia in Outpatients Maintained on Neuroleptic Medications,” Journal of Clinical Psychiatry, 54 (1993): 133–39; Morgenstern, H. and Glazer, W.M., “Identifying Risk Factors for Tardive Dyskinesia Among Long-Term Outpatients Maintained with Neuroleptic Medications,” Archives of General Psychiatry, 50 (1993): 723-33; Guy, W. et al., “The Prevalence of Abnormal Involuntary Movements Among Chronic Schizophrenics,” International Clinical Psychopharmacology, 1 (1986): 136-44; Kane, J.M. et al., “The Prevalence of Tardive Dyskinesia,” Psychopharmacology Bulletin, 21 (1985): 136-39; Kane, J.M. and Smith, J.M., “Tardive Dyskinesia: Prevalence and Risk Factors, 1959 to 1979,” Archives of General Psychiatry, 39 (1982): 473-81; and Yassa, R. and Jeste, D.V., “Gender Differences in Tardive Dyskinesia: A Critical Review of the Literature,” Schizophrenia Bulletin, 18 (1992): 701-15.Google Scholar
Jeste, D.V. and Wyatt, R.J., “Changing Epidemiology of Tardive Dyskinesia: An Overview,” American Journal of Psychiatry, 138 (1981): 297309; Kane, J.M. et al., “Tardive Dyskinesia: Prevalence, Incidence, and Risk Factors,” Journal of Clinical Psychopharmacology, 8 (1988): 528-68; and Kane, and Smith, , supra note 81.Google Scholar
Woerner, et al., supra note 80.Google Scholar
Jeste, and Caligiuri, , supra note 80; and Woerner, et al., supra note 80.Google Scholar
Cavallaro, et al., supra note 80.Google Scholar
Jeste, and Caligiuri, , supra note 80; and Glazer, W. et al., “Race and Tardive Dyskinesia Among Outpatients at a CMHC,” Hospital and Community Psychiatry, 45 (1994): 3842.Google Scholar
Eddy, D.M., “Variations in Physician Practice: The Role of Uncertainty,” Health Affairs, 3 (1984): 7489.CrossRefGoogle Scholar
Cebul, R.D., “‘A Look at the Chief Complaints’ Revisited: Current Obstacles and Opportunities for Decision Analysis,” Medical Decision Making, 4 (1984): 272–83.Google Scholar
Eddy, , supra note 87.Google Scholar
Katz, J., “Why Doctors Don't Disclose Uncertainty,” Hastings Center Report, 14 (1984): 3544; Gutheil, T.G. et al., “Malpractice Prevention Through the Sharing of Uncertainty: Informed Consent and the Therapeutic Alliance,” New England Journal of Medicine, 311 (1984): 49-51; and Carmi, A., “Medical Decisions Under Uncertainty,” Medicine and the Law, 12 (1993): 277-81.CrossRefGoogle Scholar
Mazur, D.J., “Informed Consent: Court Viewpoints and Medical Decision Making,” Medical Decision Making, 6 (1986): 224–30.CrossRefGoogle Scholar
Cobbs v. Grant, supra note 29, at 11.Google Scholar
Gutheil, et al., supra note 90.Google Scholar
Roginsky, M.S. and Wasserman, S., “Informed Consent: Past, Present, and Future?,” New York State Journal of Medicine, Nov. (1979): 1918–20.Google Scholar
Harbeson v. Parke-Davis, Inc., 746 F.2d 517 (9th Cir. 1984).Google Scholar
Brody, H., “Transparency: Informed Consent in Primary Care,” Hastings Center Report, 19 (1989): 59; and Plaut, E., “The Ethics of Informed Consent: An Overview,” Psychiatric Journal of the University of Ottawa, 14 (1989): 435-38.CrossRefGoogle Scholar
Rosoff, , supra note 12, at 47.Google Scholar
Nisenholtz v. Mount Sinai Hospital, 126 N.Y. Misc. 2d 658, 662, 483 N.Y.S.2d 568 (1984).Google Scholar
Gambrill, E., Critical Thinking in Clinical Practice: Improving the Accuracy of Judgments and Decisions About Clients (San Francisco: Jossey-Bass, 1990), at 9 and ch. 9.Google Scholar
Appelbaum, P. Lidz, C. and Meisel, A., Informed Consent: Legal Theory and Clinical Practice (New York: Oxford, 1987), at 145.Google Scholar
Lidz, C. Appelbaum, P. and Meisel, A., “Two Models of Implementing Informed Consent,” Archives of Internal Medicine, 148 (1988): 1385–89.CrossRefGoogle Scholar
Holzer, J., “A New Approach to Informed Consent Can Reduce Claims,” Pediatric Annals, 20 (1991): 6468.CrossRefGoogle Scholar
Green, J., “Minimizing Malpractice Risks by Role Clarification: The Confusing Transition from Tort to Contract,” Annals of Internal Medicine, 109 (1988): 234–41.CrossRefGoogle Scholar
Vago, S., Law and Society (Englewood Cliffs: Prentice-Hall, 1994), at 8.Google Scholar
Appelbaum, et al., supra note 100, at 145; President's Commission, supra note 19, at 30-31; and Pellegrino, E., “Toward a Reconstruction of Medical Morality: The Primacy of the Act of Profession and the Fact of Illness,” Journal of Medicine and Philosophy, 4 (1979): 3256.Google Scholar
Maldonado, , supra note 5.Google Scholar
Katz, , supra note 71, at 82; and Katz, , supra note 26, at 172-73.Google Scholar
American College of Physicians, “American College of Physicians Ethics Manual,” Annals of Internal Medicine, 101 (1984): 129–36.Google Scholar
Lidz, et al., supra note 101.Google Scholar
Brody, , supra note 96.Google Scholar
Green, supra note 103.Google Scholar
Gutheil, et al., supra note 90.Google Scholar
Dewan, M.J., “Adding Medications to Ongoing Psychotherapy: Indications and Pitfalls,” American Journal of Psychotherapy, 46 (1992): 102–10.CrossRefGoogle Scholar
Pies, R., Letter: Response to “This Prescription May be Hazardous to Your Health: Who is Accountable to the Patient?,” Journal of Clinical Psychopharmacology, 13 (1993): 457.CrossRefGoogle Scholar
Rosoff, , supra note 12, at 46.Google Scholar
Katz, , supra note 26, at 160.Google Scholar
Epstein, , supra note 43, at 127.Google Scholar
Id. at 120–21.Google Scholar
American College of Legal Medicine, supra note 16, at 221.Google Scholar
Brody, , supra note 96.Google Scholar
305 N.W.2d 589 (Minn. 1981)CrossRefGoogle Scholar
544 So.2d 567 (La. App. 1989).Google Scholar
Katz, , supra note 26, at 166; and Canterbury v. Spence, supra note 38, n. 84 at 787.Google Scholar
Green, , supra note 103; Appelbaum, et al., supra note 100; and Meyer, , supra note 21.Google Scholar
Gutheil, et al., supra note 90; and Wilkinson v. Vesey, 110 R.I. 606, 295 A.2d 676 (1972).Google Scholar
Jones, C., “Autonomy and Informed Consent in Medical Decision-Making: Toward a New Self-Fulfilling Prophecy,” Washington and Lee Law Review, 47 (1990): 379430.Google Scholar