In recent years, the proper role of informed consent doctrine in an environment of healthcare cost containment has been a hotly contested legal and policy issue. The purpose of this Note is to probe the current informed consent debate in the United States and the United Kingdom and to draw out the respective roles informed consent ought to play in those two systems. In doing so, this Note draws on the history of the doctrine and several recent scholarly proposals, and offers a modest proposal synthesizing the best aspects of those proposals.
TABLE OF CONTENTS I. INTRODUCTION II. INFORMED CONSENT IN THE UNITED STATES: HISTORICAL BACKGROUND III. WHAT SHOULD INFORMED CONSENT LOOK LIKE IN THE UNITED STATES? A. Specific Informed Consent Proposals in Recent Years i. Mark A. Hall's Theory of Economic Informed Consent ii. Peter H. Schuck's Call for Contextualization iii. Susan M. Wolf's Systemic Vision iv. Joan H. Krause's Statutory Model B. A Synthesizing Approach IV. "INFORMED CONSENT" IN THE UNITED KINGDOM: BOLAM AND ITS PROGENY V. WHAT SHOULD INFORMED CONSENT LOOK LIKE IN THE UNITED KINGDOM? VI. CONCLUSION I. INTRODUCTION
The U.S. healthcare system is widely regarded as providing the highest quality healthcare in the world. (1) Its healthcare system, however, is by no means perfect, and it could be argued that it is not the best of all healthcare systems. Although characterized by high quality, U.S. healthcare is also plagued with problems of overspending and relatively low per capita coverage compared to healthcare systems of other developed countries. (2) Therefore, among the primary goals of U.S. healthcare policymakers is to contain healthcare costs while maintaining adequate levels of treatment.
While most would agree that reduction of healthcare costs is a worthy goal, for decades the battle lines have been clearly drawn in the United States between two contrasting visions of healthcare delivery: the economic paradigm and the professional paradigm. (3) Those in the former camp envision a system that allows market forces to perform an automatic regulatory role, such that patients are able to make the kinds of cost-benefit decisions that typically face consumers, while managed care organizations are free to invent delivery structures that encourage cost containment. In other words, the economic paradigm acknowledges a valid economic concern ("Is the treatment worth the cost?") in addition to the traditional medical concern ("Is the treatment beneficial?"). (4) In contrast, those who adhere to the professional model would ask only the latter question. (5)
In the United Kingdom, on the other hand, where healthcare is provided through a public delivery system with an overall expenditure cap, (6) problems of overspending are not prevalent. Despite this, British healthcare quality is adequate to serve the needs of its population. (7) Many reasons have been offered for the lower levels of spending in the United Kingdom, and indeed it is likely that U.S. policymakers could learn some valuable lessons from the British approach that may inform U.S. policy strategies while leaving the United States' tradition of treating medical care as a private good undiminished.
In the midst of these contrasting systems and the varying ideologies pertaining to healthcare delivery stands the problem of informed consent. What role should informed consent play in each of these different systems? Should its role be the same in both nations, or is its proper function in the United States different from that in the United Kingdom? This Note will summarize the current informed consent debate in the United States and the United Kingdom and draw out the respective roles informed consent should play in those two systems. Part II of this Note describes the history of informed consent law in the United States. Part III discusses current U.S. informed consent proposals and concludes that a contract theory of informed consent, supplemented by professional disciplinary proceedings, is the best approach. Part IV tracks the history of U.K. informed consent law. Finally, Part V discusses the current U.K. informed consent debate and concludes that a model comprised of one-time global disclosure, broad information availability, professional disciplinary proceedings, and a new cause of action based on these new disclosure standards would address the most pressing issues in the current U.K. informed consent debate.
INFORMED CONSENT IN THE UNITED STATES: HISTORICAL BACKGROUND
Many explanations exist for the high level of U.S. healthcare spending. One cultural explanation is the tendency for U.S. doctors to view death as failure, despite death's certain inevitability in the long-run and frequent inevitability in the short-run. (8) The U.S. "frontier spirit" has also been cited for culturally predisposing Americans (and consequently U.S. physicians) toward action in the face of adversity, manifested in the medical care context as a tendency to treat now rather than waiting or acknowledging that further treatment will yield little or no benefit or possibly even do more harm than good. (9) In other words, Americans believe that "the main purpose of a man's life is to solve problems." (10)
Many commentators, however, point to causal connections other than cultural predispositions, such as structural aspects of the U.S. health care system. A classic example of a structural flaw in the U.S. healthcare delivery system is the once dominant fee-for-service model of healthcare delivery. This model engendered a tradition of superfluous delivery of care under the guise of medical necessity, spurred on by the relative ease of passing on costs to both insurance companies and the government, often viewed as impersonal bottomless pits that are unaffected by the individual's relatively small discrete expenditures. (11) While the goal of managed care is to reduce the overspending brought on by the fee-for-service world of yesteryear, old habits die hard and vestiges of the old ways of thinking about healthcare spending still surface in the practice of defensive medicine, the technological imperative, and other common utilization-increasing aspects of our health system. (12)
It is apparent that the doctrine of informed consent is relevant to the U.S. cost-containment debate. One way to illustrate the parallels between informed consent doctrine and the overall approach to healthcare delivery is to look to the lessons of history. The doctrinal roots of informed consent can be traced back at least as far as the eighteenth century ethical debate between Thomas Percival and John Gregory.
Percival's ethics were characterized by opposition to any kind of price or quality competition among physicians. (13) Furthermore, Percival favored monopolistic self-regulation by the medical profession. (14) "For Percival, the Enlightenment and rationality were available only to the elites paternalistically bound to assuming the burden of protecting the public." (15) In contrast, Gregory criticized the monopolistic and paternalistic tendencies of the Percivalean ethic. (16) Gregory believed that the medical profession could benefit, as do other professions, from a dose of competition (what he called "private interest"). (17) However, Gregory felt that medical science and practice were kept too secret for the public to adequately judge the merit of particular physicians. (18)
Even today, the tension between Percival and Gregory is felt. The debate between the professional paradigm and the economic paradigm centers on the ability of patients, as consumers, to adequately digest medical information for the purpose of making informed treatment decisions. (19) Proponents of the professional model, for example, tend to point to market failure--asymmetry of information--as engendering the need for a monopolistic substitution for the market in the form of a self-regulated, paternalistic profession. (20) In contrast, supporters of the economic model might look to professionalism as the cause of the market's difficulties, rather than their cure. (21) The roots of professionalism are characterized by a Percivalean tendency to discount the ability of patients to understand medical information; in contrast, Gregory expressed concern that patients were incapable of judging medical skill only because medical information was kept too secret from them. (22)
And yet, the realization that informed consent has significance in the cost-containment debate is not sufficient. This realization leaves unanswered the question, "How should informed consent be structured in the managed-care era?" In Part III, this Note will attempt to answer that question, but first this Note provides an introduction to the historical development of the doctrine of informed consent in the United States.
The doctrine of informed consent in the U.S. healthcare context holds as its driving value the concepts of autonomy and self-determination. (23) These deep-seated values explain why U.S. courts initially analyzed the duty to obtain a patient's consent to treatment under the ambit of the tort of battery. (24) In the 1914 case of Schloendorff v. Society of New York Hospital, (25) where a doctor performed surgery on a patient who consented to examination under anesthesia but explicitly stated that "there must be no operation," (26) Judge Benjamin Cardozo stated: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent, commits an assault, for which he is liable in damages." (27) Therefore, plaintiffs in early informed consent cases were required to show that their doctors made undesired contact with the patient intentionally and without consent. (28)
As surgery became more commonplace and surgeons' work more trusted, however, the fear of unauthorized surgery became less significant. (29) At that time, the judicial focus...