University at Buffalo School of Law Digital Commons @ University at Buffalo School of Law Journal Articles Faculty Scholarship 1-1-1994 Beyond Informed Consent Anthony H. Szczygiel University at Buffalo School of Law Follow this and additional works at: https://digitalcommons.law.buffalo.edu/journal_articles Part of the Health Law and Policy Commons Recommended Citation Anthony H. Szczygiel, Beyond Informed Consent, 21 Ohio N.U. L. Rev. 171 (1994). Available at: https://digitalcommons.law.buffalo.edu/journal_articles/749 This Article is brought to you for free and open access by the Faculty Scholarship at Digital Commons @ University at Buffalo School of Law. It has been accepted for inclusion in Journal Articles by an authorized administrator of Digital Commons @ University at Buffalo School of Law. For more information, please contact [email protected]. Beyond Informed Consent ANTHONY SZCZYGIEL* I. INTRODUCTION The role of a patient in determining the course of medical treatment has evolved over time in response to changes in the status of physicians and medical knowledge. Ideas about a patient's right of self determination are continuing to develop, increasingly empha- sizing the patient-provider relationship as a cooperative venture. This trend is supported by newly articulated professional medical ethics. However, structural changes within the medical care industry and budget driven initiatives designed to change the way medicine is practiced threaten to overwhelm this movement toward fuller patient participation. One important issue in the evolving process of medical care giving is how the patient-provider relationship will be affected by these changes. A related concern is how best to define and support effective patient participation in the evolving process of medical decision making. The legal system has had a limited, but important, impact on the evolution of the patient-provider relationship. In the twentieth cen- tury, we can identify two periods of intense development in the law directly focused on patient decision making: the Era of Consent (roughly 1905 to 1930) and the Era of Informed Consent (roughly 1957 to present). The courts played a leading role in both eras as the forum in which new interactive norms were articulated, publicized, and enforced.' Legal responsibilities placed on medical professionals reflect, in part, concerns about the risks borne by patients who rely on the professional's advice or treatment. Legal standards evolved to give greater weight to patient autonomy by creating a role for patients in determining whether to undertake the risks of treatment. 2 * Clinical Associate Professor at the SUNY at Buffalo School of Law. B.A., 1972, with honors in Economics, SUNY at Buffalo; J.D., 1975, University of California, Berkeley (Boalt Hall) Law School. 1. RUTH R. FADEN & TOM L. BEAUCWAP, A HISTORY AND THEORY OF INFORMED CONSENT 142 (1986) [hereinafter FADEN & BEAUCHAMP]. State legislatures had a limited involve- ment during the Era of Informed Consent. They responded to limit the common law rejection of professional practice standards in informed consent cases. FADEN & BEAUCHAMP, supra at 114-143. 2. See FADEN & BEAUCHAMP, supra note 1, at 114-143. 172 OHIO NORTHERN UNIVERSITY LAW REVIEW [Vol. 21 The development of the informed consent doctrines in the courts and state legislatures is a story nearing its final chapter.' Every U.S. jurisdiction has adopted an informed consent doctrine and has chosen a minimal disclosure standard.4 With few exceptions, the standards have not changed in the past ten years . Surprisingly, the medical profession has recently revitalized the doctrine for one more round of policy development by providing a new definition of what is expected from a reasonable practitioner.6 New ethics code provisions reassert the profession's role in defining the provider-patient relation- ship, while recognizing a patient's right to self determination. 7 The principles adopted go beyond the doctrines established by the courts and legislatures, both in their scope and the extent to which the patient's choices are to be respected.8 These developments raise the possibility that the patient-medical professional relationship may be moving beyond the minimal require- ments of current informed consent doctrine. However, a host of developments, including budgetary restraints, increased reliance on management of care, a decline in the status of physicians, and the continuing depersonalization of individual medical care are challeng- ing this opportunity. Choices being made now to reform the health care system will determine whether patient involvement will sink to the level of a "Medical Miranda Warning" 9 or evolve toward a process that more actively involves the patient. In response to the problems of limited access to medical care and sharply rising costs, insurance companies, employers, government and other payers are experimenting with initiatives designed to change the practice of medicine. These programs have a special emphasis on the physician's role. One major change is the explicit consideration of cost in treatment decisions. Long standing deference to professional 3. See FADEN AND BEAUCHAMP, supra note 1; PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL RESEARCH, A REPORT ON THE ETHICAL AND LEGAL IMPLICATIONS OF INFORMED CONSENT IN THE PATIENT-PRACTITIONER RELATIONSHIP (October 1982) [hereinafter PRESIDENT'S COMMISSION]. 4. See infra Section 1II(F) text and accompanying footnotes. 5. Id. 6. See AMA PRINCIPLES OF MEDICAL ETHICS, reprinted in JUDICIAL COUNCIL OF THE AMERICAN MEDICAL ASSOCIATION, CURRENT OPINIONS OF THE JUDICIAL COUNCIL OF THE AMER- ICAN MEDICAL ASSOCIATION - 1981 [hereinafter CURRENT OPINIONS - 19811; AMERICAN COLLEGE OF PHYSICIANS, ETHICS MANUAL, reprinted in 101 ANNALS OF INTERN. MED., 129-37, 263-74 (1984) [hereinafter ETHICS MANUAL]. 7. CURRENT OPINIONS - 1981; ETHICS MANUAL, supra note 6. 8. This codification in the professional ethic brought an end to the policy debate over the general desirability of patient participation. Patient participation is now a component of medical care quality, measured by the extent to which professional culture and practice match the expectations of patients and, more generally, society. 9. ALAN MEISEL, THE RIGHT TO DIE § 2.5, at 21, 22 (1989). 1994] BEYOND INFORMED CONSENT self-regulation is giving way to reimbursement methodologies and utilization review standards designed to encourage cost awareness in medical providers and to reduce variations in practice patterns. Re- imbursement methodologies are being redesigned to influence the amount and type of medical care provided. New approaches to util- ization review will intensify the pressure to make choosing the most cost-effective regimen of care a part of professional responsibility. Further change is occurring because the medical care industry is restructuring itself in response to changing demographics and care needs, as well as in response to the new reimbursement trends. Managed care exemplifies these changes. The various forms of man- aged care Share the characteristics of bringing the insurance risk to bear more directly on treatment decisions. Participating providers agree to abide by group practice protocols. In this process, physicians cede some of their clinical discretion to medical care administrators. Patients find themselves dealing with a medical care group rather than the prototypical family doctor. The complexity of the systems and the novelty of the means of intervention are producing very mixed results. The changes have slightly narrowed the gap between the rate of medical care inflation and the overall rate of inflation. However, the private sector has been cutting back on the medical coverage it provides faster than the public sector has been expanding its coverage. This set the stage for the Clinton Administration's far-reaching proposal to extend medical coverage and impose cost containment mechanisms: 0 the Health Se- curity Act." Unlike in prior eras, federal policy is playing a leading role in how the new patient-provider relationship develops. The failure of Congress to enact the Health Security Act or any of the competing 2 bills will slow, but not stop, the pace of change. The changes underway will significantly affect the interaction between medical professionals and patients in ways intended and unforeseen. The net impact on the role of the patient will be deter- mined by the reaction of the medical providers, the balance struck 10. See Renee Blankenau, CBO Study Takes Technical Angle, Leaves Politics for Congress; Congressional Budget Office Study on Healthcare Reform, HOSPITALS, Mar. 5, 1994, at 14; Clinton Plan Will Reduce Deficit Less Than Earlier Estimated, Moynihan Says, 2 HEALTH L. REP. (BNA) 42 (Oct. 25, 1993); Thomas Scarlett, Killing Health Care Reform: How Clinton's Opponents Used a Political Media Campaign to Lobby Congress and Sway Public Opinion, CAMPAIGNS & ELECTIONS (Nexis-Current News) (Oct. 1994). 11. H.R. 3600, 103d Cong., 1st Sess. (1993); S. 1757, 103d Cong., 1st Sess. (1993). Slightly altered versions were introduced in the Senate. S. 1775, 103d Cong., 1st Sess. (1993); S. 1779, 103d Cong., 1st Sess. (1993). 12. The Congress failed to enact any version of the Health Security Act prior to the close of the 1994 legislative session. 174 OHIO NORTHERN UNIVERSITY LAW REVIEW [Vol. 21 between cost and quality, the effectiveness of administrative oversight, and the extent to which patient