American Journal of Law & Medicine

Rethinking informed consent: the case for shared medical decision-making.

I. INTRODUCTION

In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.

This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent. (1)

Currently, the states are almost evenly split between two types of standards for informed consent--the physician-based standard, effective in 25 states, and the patient-based standard, effective in 23 states and the District of Columbia. (2) Physician-based standards generally require physicians to inform a patient of the risks, benefits and alternatives to a treatment in the same manner that a "reasonably prudent practitioner" in the field would. (3) On the other hand, patient-based standards hold physicians responsible for providing patients with all information on the risks, benefits and alternatives to a treatment that a "reasonable patient" would attach significance to in making a treatment decision. (4) As can be seen in the cases listed in Appendix A, while each state may have its own variation on the language of its informed consent standard, they are quite representative of classification, and so, we will discuss the physician and patient-based standards each as a unified standard for the remainder of the paper.

Recent findings of health-services research challenge the validity of important assumptions that underlie our two informed consent standards. For instance, research performed by John Wennberg and colleagues demonstrates that around one-third of all medical decisions should depend largely on the values and preferences of the patient, rather than the norms of physician practice, as is the law under the physician-based standard. (5) Patient preferences for information disclosure, risk taking, quality of life outcomes and tolerance of side effects differ greatly amongst the patient population, (6) yet variations in treatment decisions often do not reflect differences in patient choice. (7) In cases where patient lifestyle, personal preferences and values are indicative of the most appropriate treatment choice, physicians are not in the best position to make treatment decisions and should not limit disclosure of alternatives. In addition, research by Deb Feldman-Stewart and colleagues demonstrates that patients vary widely in their disclosure preferences and needs, (8) indicating that contrary to the principles of individual autonomy and self-determination, our objective legal standards of informed consent that depend on the informational needs of a "reasonable patient" may deny many patients the amount of information they require to give an informed consent to treatment.

In the last decade, a small but distinguished group of medical and even some legal scholars have sought to address this dilemma by calling for a revision of our current methods of informed consent in favor of shared medical decision-making. (9) Shared medical decision-making is a process in which the physician shares with the patient all relevant risk and benefit information on all treatment alternatives and the patient shares with the physician all relevant personal information that might make one treatment or side effect more or less tolerable than others. (10) Then, both parties use this information to come to a mutual medical decision. (11) Advocates of shared medical decision-making praise its improvements in patient autonomy and comprehension, its ability to reduce unwanted medical procedures and services, and its potential for increased communication and trust between physicians and patients. (12) Given the current move in U.S. health policy toward increased consumer responsibility in funding medical treatments, considering whether patients receive sufficient information and decision support to enable them to meaningfully participate in their health care is more imperative than ever.

Interestingly, however, a growing number of scholars and practitioners have begun to question the practicality of shared medical decision-making in the literature, (13) while the silent majority of physicians have also expressed their reluctance to change through inaction. (14) Commonly heard criticisms include complaints that shared decision-making will take too much time in today's rushed medical practice, that implementation will place unbearable financial strain on the already overburdened medical system, that physicians do not have the support and resources to provide all the evidence, and that patients do not understand or want the information. (15)

This article examines the dilemma faced by physicians, judges and policymakers in establishing an appropriate standard of medical decision-making that enables patients to make an informed treatment decision, and argues that the states should clarify their current informed consent requirements to include shared medical decision-making as a prerequisite to a valid informed consent. Since the scope of this article is intended for a wide variety of audiences, we have included detailed backgrounds of both the current informed consent system and some of the relevant health services research. Part II provides a brief example that epitomizes the challenges associated with modern informed consent practices. Parts III and IV review the ethical and legal foundations of informed consent respectively. Part IV also gives an overview of the two current legal frameworks of informed consent. Part V examines the clinical evidence for treatment patterns and patient information needs that raise questions about key assumptions of the current legal standards. Part VI demonstrates how this evidence threatens the validity of our current legal standards. Part VII presents clinical evidence of the failure of the current medical system to provide sufficient information to individuals making medical decisions. Part VIII introduces shared medical decision-making as a potential solution and describes its benefits and challenges. Part IX compares the effectiveness and implications of the three different standards of informed consent, physician-based, patient-based and shared medical decision-making, across two hypothetical cases. Part X analyzes the policy implications and modifications in medical practice required to implement shared decision-making. Finally, Part XI summarizes the arguments and concludes that states should adopt the shared medical decision-making model as a prerequisite to legal informed consent.

II. THE MERENSTEIN CASE

In an editorial in the Journal of the American Medical Association, Dr. Daniel Merenstein relayed the facts of an unpublished trial that revealed just what was at stake in determining how much information to disclose to patients. (16) Early on in his residency program in Virginia, Dr. Merenstein gave a physical exam to a highly educated patient in his mid-fifties. (17) Dr. Merenstein testified at trial that during the exam, he discussed with the patient "the importance of colon cancer screening, seat belts, dental care, exercise, improved diet, and sunscreen use." (18) In accordance with the practice guidelines established by the United States Preventative Services Task Force, the American College of Physicians--American Society of Internal Medicine, the American Medical Association, the American Urological Association, the American Cancer Association, and the American Association of Family Physicians he also engaged in a shared medical decision-making process of discussing all of the relevant risks and benefits regarding screening for prostate cancer via the prostate specific antigen (PSA) test with the patient. (19)

The medical associations recommend shared medical decision-making for patients determining whether to have a PSA test for a number of reasons. While the PSA test can detect early-stage prostate cancer, only mixed and inconclusive evidence exists to suggest the ability of PSA screening to improve health outcomes. (20) In addition, screening is associated with a number of health harms, despite the benign nature of the blood test itself. (21) PSAs frequently provide false-positive results or detect prostate cancer that would never harm the patient. (22) By identifying non-threatening or non-existent cancer, the PSA test often leads patients to have unnecessary surgical or radiation treatments with significant side effects, such as impotence and incontinence. For instance, while radical prostatectomy has been demonstrated to reduce mortality for men with localized prostate cancer detected from patient-reported symptoms, (23) this result has not yet been found for cancer identified via PSA screening. Still, many patients with PSA-detected cancer undergo a prostatectomy. (24) As a result, patients often endure substantial anxiety, unpleasant treatments and side effects to rid themselves of cancer that would never have affected their health. (25) In short, the harms of PSA testing can be established, but the benefits currently cannot. Given the risks associated with having the test and the indeterminate benefit, a number of national medical associations concluded that each asymptomatic patient should determine whether he preferred to have the test upon reaching a certain age or to wait until symptoms suggested the test was appropriate. (26)

Dr. Merenstein testified that after learning of the high false positive rates associated with the prostate specific antigen (PSA) test, the substantial risk of side effects that may reduce his quality of life, and the low likelihood of death from prostate cancer, his patient declined the testy Following the visit, Dr. Merenstein never saw the man as a patient again. (28)

Sometime after Merenstein completed his residency program, the patient saw a physician at a different clinic. (29) Without discussing the decision to screen for prostate cancer with the patient, the new physician performed a PSA test. (30) Unfortunately for the patient, his PSA level was very high, which led to a subsequent diagnosis of incurable, advanced-stage prostate cancer. (31)

The malpractice trial began on June 23, 2003. (32) Dr. Merenstein was "nervous but confident," as he had documented discussing the risks and benefits of the PSA with the patient and noted the patient's decision to decline after considering all of the facts. (33) However, once the trial started, Dr. Merenstein's confidence began to wane.

To his surprise, Dr. Merenstein listened to the plaintiffs attorney argue that despite the fact that practice guidelines established by the American Academy of Family Physicians, the American Urological Association, and the American Cancer Society all recommended that physicians discuss the risks and benefits of PSA screening with patients, this behavior constituted malpractice in Virginia. (34) In all states, to win a medical malpractice case, the plaintiff must prove that the physician violated the standard of care, which in turn resulted in the patient's injury. (35) Due to the minimal risks associated with performing a PSA (a simple blood test), the plaintiff's attorney argued that the standard of care in Virginia was to order the test without discussing it with the patient. (36) With four physician witnesses from the state of Virginia to support his claim, the plaintiffs attorney won his case against Merenstein's residency program, and seemingly against the use of evidence-based medicine and shared medical decision-making. (37)

Because the decision was an unreported jury verdict, it is impossible to know which facts the jury's decision hinged on. A finding, however, that a Virginia physician should provide a controversial test without discussing the possible risks, benefits and alternatives with his or her patient at a minimum demonstrates a great deal of tension between what is happening in some state courts and the current recommendations of medical associations and medical schools. While the case represents a worst-case scenario for both the patient and Dr. Merenstein, it raises a broad range of challenges facing physicians, patients and policymakers regarding the disclosure of medical information. How should physicians inform patients of tests or treatments with questionable efficacy? What level of disclosure coincides with their legal requirements? Should patients place blind faith in their physician's decisions or take a more active role in and responsibility for their medical care? Are patients up to the challenge of making their own medical decisions? Who should bear the responsibility when the risks accepted in a difficult decision come to fruition? Finally, how can policymakers best provide physicians and patients with clear guidelines that allow them to comprehend their rights and responsibilities? Each of these dilemmas has its roots in the ethical and legal underpinnings of informed consent.

III. ETHICAL FOUNDATIONS OF INFORMED CONSENT

The legal basis for informed consent arises largely from fundamental principles of medical ethics and human rights. These principles should inform and guide the goals we establish for a system of informed consent. In Beauchamp and Childress' foundational text The Principles of Bioethics, they identify four main principles that should guide the practice of medicine: autonomy, beneficence, nonmalfeasance, and justice. (38) Often these ethical principles conflict with one another in the everyday practice of medicine. (39) The most challenging dilemma in establishing an effective informed consent practice is balancing a physician's obligation to protect the patient's health through beneficence and the physician's obligation to respect the patient's autonomy. (40)

Patient autonomy is the most well known principle of medical ethics. Proponents of autonomy claim its heritage from religion, natural law and moral philosophy. (41) The Puritans derived a notion of autonomy from personal religious responsibility and individual conscience, which were balanced against the individual's obligation to serve the community. (42) Autonomy's roots are also found in natural law, which protects the individual's right to self-govern and the freedom to pursue one's own dictates. (43) Others hold the individual autonomy discussed in bioethics to be derived from Immanuel Kant's belief that autonomy was fundamental to moral action. (44) Regardless of its original roots, within the realm of bioethics, patient autonomy can be translated as the ethical principle that preserves an individual's ability to make and carry out informed decisions that arise from unbiased and thoughtful deliberation. (45) Self-determination is the subset of autonomy most commonly associated with informed consent and health care, such that decisions originate freely from an autonomous agent, who understands the facts and can engage in practical reasoning to come to a decision. (46) Physicians have an obligation to respect the right of patients to have sufficient knowledge regarding their medical condition and treatment choices to make an autonomous medical decision. (47)

Physicians also bear an obligation to act with beneficence toward their patients. (48) The principle of beneficence confers a moral obligation on physicians to act for the benefit of their patients. (49) In the practice of medicine, the principle of maximizing utility, an extension of the principle of beneficence is most commonly applied. (50) Rarely are physicians able to produce benefits without creating additional risks or incurring some costs. As a result, to act with beneficence, they must act only when the benefits warrant the risks and costs associated with the procedure. (51) However, beneficence must be constrained by autonomy to prevent the rights of individuals from being subjugated to the medical needs of themselves or others. (52)

A patient's ability to exercise self-determination often conflicts with a physician's ethical duty of beneficence. Physicians want to provide the care they believe is best for the patient, but also must acknowledge the patient's preferences. (53) This dilemma raises the extremely important question of whether the physician's primary obligation is to act for the patient's medical benefit or to promote his or her autonomous medical decision-making.

Answering this question is essential to defining the scope of the legal requirements for informed consent. Over the last few decades, it has been widely acknowledged in the literature that autonomy has been given substantial priority over the other ethical principles, including beneficence. (54) The ascendance of autonomy has occurred for a number of practical and political reasons: 1) protecting autonomy is more easily aligned with existing legal principles and precedents; 2) promoting patient autonomy may relieve the physician of some responsibility and liability; 3) emphasizing patient autonomy coincides with and supports the recent shift toward consumerism in medicine; and 4) promoting autonomy appears less paternalistic than beneficence, but still permits physicians to control the flow of information. (55)

However, in practice, patient autonomy alone as a guiding principle proves insufficient. Patients do not want to simply be given facts by their physicians and left to make their own medical decisions. In the same way that beneficence must be constrained by autonomy, so must autonomy be constrained by beneficence. Many seek medical care to relinquish some of their autonomy and responsibility to the experts. (56) Enabling a patient to exercise her autonomy does not hinder the physician's ability to provide a medical opinion. In the shared decision-making process, the patient may make an autonomous choice to participate in a full or limited way or not at all in making the final decision after receiving the relevant information. Just because patients may wish to defer to their physicians' best judgment after a discussion, however, does not mean that their autonomy was compromised, the discussion was worthless or it did not add value to the patient's overall health care. (57) Instead, physician participation and beneficence enhances a patient's ability to make an autonomous choice.

Ethically, we need a standard that balances beneficence and respect for patient autonomy; that tips in favor of autonomy in equally balanced situations. Our legal standard of informed consent should strive to protect patients' ability to obtain information and either make decisions or defer decision-making to their physician. It should permit physicians to present and support their medical opinions, as well as provide them with a clear understanding of what other information should be disclosed. Under such a standard, the physician should: 1) provide the patient with unbiased information on the risks and benefits of all treatment options; 2) give the patient their professional advice; 3) assist the patient in identifying their own values; and 4) decide with the patient which treatment choice is best. Under this standard, both patient autonomy and physician beneficence are valued and expressed in a manner that allows the patient and the physician to come to a mutual treatment decision that balances the importance of all competing factors. The next section traces the history and evolution of informed consent law.

IV. THE LEGAL FOUNDATIONS OF INFORMED CONSENT

As the nature of the physician-patient relationship has become more complex and the clinical information available increases, the legal system must continue to adapt the informed consent doctrine to meet the needs of both physicians and patients. To determine how best to shape our informed consent laws for the future, it is important to examine how the law has evolved over time. The legal notion of consent to medical treatment was originally derived from the ethical principle of personal autonomy and its subsets: self-determination and bodily integrity. (58) These principles have been established in law by state informed consent legislation and medical malpractice case law.

The legal evolution of informed consent has in many ways mirrored changes in the practice of medicine. Three times in the last century the law has adapted to meet the needs of an evolving medical system. First, courts created a cause of action under battery for patients who had been wrongfully injured by their physicians. (59) Next, case law shifted from battery claims for unwanted touching to negligence claims for failure to fulfill a duty to provide the patient with sufficient information to make a personal medical decision. (60) Since 1972, some state courts have elected to expand the patients' role in medical decision-making by altering the negligence standard from one based on what information a reasonably prudent physician would give (physician-based standard) to one concerned with what information a reasonable patient would want (objective patient-based standard). (61) In addition, a tiny fraction of states have gone further to base their standard on the level of information desired by the individual patient, regardless of whether others found the information pertinent to the decision (subjective patient-based standard). (62) Knowledge of the evolution of these three standards is essential to understanding our current informed consent laws and how to best implement change.

A. BATTERY IN INFORMED CONSENT

The legal obligation to obtain patient consent was first established in early surgical malpractice cases, in which the court ruled that the physician violated the "bodily integrity of his patient," by committing an unwanted touching. (63) Battery is an intentional tort, for which an individual is liable if he intentionally causes offensive or harmful contact with another. (64) For instance, in 1905, the court, in Mohr v. Williams, (65) recognized a cause of action under battery for an individual who consented to an operation on his right ear, but the physician during surgery operated on his left ear as well. (66) In making its decision, the court emphasized a patient's "right to himself' as a "free citizen's first and greatest right" and that this "right to himself' prohibited the physician from violating "the bodily integrity of his patient" without his or her knowledge and consent. (67) In addition, the court highlighted the importance of the patient's decision-making process by limiting the scope of consent to only those procedures for which the physician provided information sufficient to permit the patient to accurately balance the risks and benefits in making a decision. (68) Despite this language emphasizing the patient's role, the focus in these early cases was not on self determination, but the right to bodily integrity.

In Schloendorff v. Society of New York Hospital, (69) Judge Cardozo refined the right to patient consent by holding that the cause of action under battery relied on the violation of bodily integrity, rather than any specific harm arising from the unwanted touching. (70) Under this interpretation, a surgeon could be liable for damages the moment he performed any procedure outside the scope of the consent, regardless of whether the patient received any physical injury. (71)

Battery, however, proved insufficient to fully capture the importance of a patient's knowledge of the risks, benefits, and alternatives of a procedure, as well as ability to use his or her own value system to decide whether to pursue a certain procedure or treatment. Medical treatment also encompassed more outpatient treatment and non-surgical procedures for which the un-consented touching requirement of battery seemed inappropriate. Over the next few decades, the courts turned their focus in patient consent cases away from battery and bodily integrity toward the value of patient autonomy.

B. THE NEGLIGENCE STANDARD IN INFORMED CONSENT

The shift from battery to a negligence standard reflected judges' sentiments that a judgment of battery was inappropriate for the nature of the offense, as physicians did not intend to harm the patient, rather they failed to provide enough information. (72) In addition, judges felt a need to respond to the growing patient demand for information. (73) Physician and legal scholar Jay Katz posited a number of reasons why judges preferred a negligence standard to battery: 1) battery allows for very few defenses, unlike negligence; 2) judges preferred to base the legal standard for physician behavior on actual practice rather than legal theory; 3) a negligence standard permitted judges to defer to the wisdom of the medical profession, so that physicians would only be liable for failing to disclose information that other physicians would have provided; and 4) negligence law places a bigger burden of proof on plaintiffs so as to deter frivolous claims that battery would have allowed. (74) In addition, the tort of battery has a counterpart in criminal law, which could potentially leave a physician open to criminal charges for un-consented touching. (75) In short, judges did not want to interfere in the ability of physicians to use their medical wisdom and expertise to make treatment decisions or subject them to criminal liability, but they did want to protect the general autonomy of patients to know and agree to procedures performed on their own bodies.

In the 1950's, courts began to acknowledge the growing number of cases that arose, not because a physician failed to receive consent to perform a certain procedure, but because the physician failed to provide the patient with sufficient information regarding the relevant risks, benefits or alternatives of the procedure to enable her to make an informed decision. (76) To provide a remedy, courts began recognizing causes of action for negligence arising out of a physician's breach of a duty to provide their patient with enough information to allow them to give an "informed consent." This duty obligated physicians to "disclose and explain to the patient in language as simple as necessary the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body." (77) Judges of the time felt no need to clarify the scope of the informed consent or the extent of patients' rights because they believed they were codifying the current practices of the medical profession. (78)

Over the last fifty years, individual states have increasingly required physicians to provide patients with proper information regarding the risks, benefits, and alternatives to any treatment. The specific amount and nature of information the law requires physicians to provide patients to make such determinations, however, remain largely in question. While informed consent requirements have generally shifted from an emphasis on physician preferences toward more patient autonomy and involvement, this evolution has not occurred evenly across states. (79) The initial negligence standard deferred openly to the practice patterns of other physicians. Currently, around half of the states have altered their laws to value patient autonomy over physician practice with respect to informed consent. (80)

1. Physician-Based Standard

a. Foundational Cases

In establishing the original negligence standard, now known as the "physician-based standard," judges sought to protect patient autonomy, but deferred openly to the wisdom and common practice of the members of the medical profession in a way that severely compromised their efforts. (81) In 1957, the California Court of Appeals established the first negligence standard for informed consent in Salgo v. Leland Stanford, Jr. University. (82) To remedy a 55 year-old man's intermittent limping, the physicians performed an aortography procedure that was not yet the standard of care. (83) Following the surgery, which had seemed free from complication, the patient awoke entirely paralyzed in both legs. (84) His surgeon, Dr. Gerbode, had failed to inform the patient of any risk of paralysis. (85) Judge Bray, who found the patient very sympathetic and without remedy under battery, adopted the informed consent language verbatim from the amicus brief submitted by the American College of Surgeons. (86) The brief stated "a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment." (87) Interestingly, this language seems to suggest that a physician's duty to inform is subjectively based upon the information important to his individual patient. Later in the opinion, however, Judge Bray diminished the impact of his prior statement by granting physicians "a certain amount of discretion" in discussing the element of risk with patients, consistent with a disclosure of the facts necessary to make an informed consent. (88) In creating this exception, Justice Bray failed to clarify how and to what extent physicians could use their discretion. As a result, this exception threatens to swallow the rule.

Three years later in Natanson v. Kline, (89) Justice Schroeder of the Kansas Supreme Court sought to promote self-determination in patients, but also to counterbalance this by granting physicians substantial leeway via the physician-based standard and the therapeutic privilege. (90) Under the physician-based standard, the court qualified the physician's disclosure duty as "limited to those disclosures which a reasonable medical practitioner would make under the same or similar circumstances." (91) The court continued its deference by stating that "how the physician may best discharge his obligation to the patient in this difficult situation involves primarily a question of medical judgment." (92) Likewise, the therapeutic privilege permits physicians to withhold diagnosis or other information in cases where they believe disclosure might jeopardize recovery of the patient. (93)

The Natanson opinion established the law on medical disclosure and informed consent for the next twelve years in almost all jurisdictions that considered those issues. (94) Despite its widespread adoption among the states, the opinion did little to clarify physicians' legal obligations with respect to disclosure. This kind of ambiguity has plagued the legal informed consent doctrine from the beginning, leaving physicians and patients in the dark about of the level of disclosure required.

b. The Current Physician-Based Standard

By granting physicians discretion in determining how much information to provide patients, the amount of disclosure required to meet the legal standard of care was defined in reference to the actions of other physicians. (95) For a medical malpractice action, the standard of care generally requires physicians to "inform a patient of the dangers of, possible negative consequences of, and alternatives to a proposed treatment or procedure" to the same degree that a "reasonably prudent practitioner in the same field of practice or specialty in [that state]" would. (96) In order to bring a claim for breach of informed consent, a patient must prove (1) that a "reasonably prudent practitioner" would have provided the additional information, (2) that the patient would not have undergone the procedure had that information been given, and (3) therefore, the physician's omissions were the proximate cause of the patient's injuries. (97) Any breach of the applicable standard of care must be established by expert testimony, which would require another physician in the state to testify stating that a reasonably prudent physician would have disclosed the omitted information. (98) As seen in the Merenstein case, this standard also provides that if a "reasonably prudent physician" in meeting the standard of care would not provide the patient with any information regarding the risks and benefits of the test, then a total lack of disclosure would meet the standard of care. (99) This standard remains the law in 25 states. (100)

2. Patient-Based Standard

a. The Objective Patient-Based Standard--Canterbury v. Spence

After twelve to fifteen years with only a physician-based standard, some states began to shift their informed consent standards in response to patient need. In 1972, the Appeals Court for the District of Columbia, in Canterbury v. Spence, (101) rejected the physician-based standard in favor of a standard of care that more adequately protected patients' interests. (102) As in Mohr v. Williams, (103) the Canterbury decision focused significantly on the patient's decision-making process and the importance of having the autonomy to weigh the risks and benefits for oneself. (104) The case involved a nineteen year-old boy who underwent surgery for severe back pain and experienced complications that resulted in paralysis. (105) The physicians failed to warn the patient of any risk of paralysis from the procedure, and the patient sued for malpractice and failure to fully disclose the risks necessary to allow the patient to make an informed consent. (106)

The court began its assessment of the case from the foundation of self-determination. Quoting Judge Cardozo in Schloendorff, the court held that the foundation of informed consent lies in "the concept, fundamental in American jurisprudence, that 'every human being of adult years and sound mind has a right to determine what shall be done with his own body.'" (107) Judge Robinson argued that "[t]rue consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each." (108) In doing so, he acknowledged the shortcomings of the physician standard that "physicians may or may not impose upon themselves." (109) By openly casting doubt upon the reality of physician consensus on acceptable disclosure practices, Judge Robinson first questioned a fundamental assumption of the physician-based standard. (110) The Canterbury court replaced the physician-based standard with one that acknowledged a larger role for patients in determining whether to proceed with medical treatment. Under the new standard, medical expertise maintained a substantial role in determining diagnosis and the available treatment options, but once those were established, physician expertise would no longer subsume objective patient preference. (111) Under the new objective patient-based standard, "the test for determining whether a particular peril must be divulged is its materiality to the patient's decision: all risks potentially affecting the decision must be unmasked." (112) Materiality was determined objectively, such that only those risks that "a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to" would constitute a "material" risk. (113)

While this standard makes large strides in the name of patient autonomy, it assumes that all patients value risks and benefits similarly. As a result, it is based on the needs of an objective or reasonable patient, rather than the subjective patient who will actually undergo the procedure. This objective standard protects physicians from the whims and idiosyncrasies of individual patients. While requiring some provision of information to patients, the Canterbury opinion also followed Salgo and Natanson in providing great deference to physicians' decisions when "medical judgment enters the picture" without further guidance or description as to what constituted medical judgment or what factors could be used to distinguish medical from non-medical judgments. …

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