Not-so-informed consent: using the doctor-patient relationship to promote state-supported outcomes.

• Author: Roe, Amanda McMurray

Over the past several decades, the informed consent doctrine has become a staple of our health care system, creating a monumental shift in the way we practice medicine. For much of our medical history, the Hippocratic Oath to "do no harm" meant doctors paternalistically determined what they believed to be the appropriate course of treatment for their patients. (1) Now, instead of simply following the will of their doctors, patients generally prefer to take a more active role in their health care, deciding which treatments, if any, are most appropriate for their individual circumstances. (2)

The informed consent doctrine highlights patient autonomy as its core value, emphasizing the importance of providing patients with the medical information needed to make a treatment decision that is both fully informed and in accordance with the patient's beliefs and priorities. (3) Although both the common law and its later statutory embodiment set baseline standards for the types of information to be provided, the informed consent doctrine has traditionally left doctors significant leeway to determine the appropriate treatment information to share with their patients and how best to convey it. (4) Ideally, the process is one that promotes the type of thoughtful and effective communication between a patient and her physician that ultimately allows the patient to realistically and objectively balance the risks and benefits of a proposed course of care. (5)

The relatively recent development of informed consent statutes for specific procedures, however, seems to have upended the traditional notion of informed consent. Instead of promoting autonomous choice, these statutes mandate that doctors provide particular disclosures about certain procedures. In addition, rather than providing patients with objective information, some of these statutes appear to provide patients with slanted information that pushes them toward a predetermined "right" choice. (6) This is especially true with abortion, (7) which, as a hot-button issue, has received a great deal of legislative attention with regard to specific informed consent requirements. (8) Given recent developments in the courts, this attention is only likely to increase. (9)

Specific informed consent statutes, though purportedly intended to enhance informed consent and protect patients when physicians fail to provide the appropriate level of information, have often failed to bring about the desired improvements. (10) With abortion statutes, some state legislatures have gone even further, creating statutes that dispense with the need to provide objective information, and instead impose a clear moral prerogative to manipulate women's ultimate decisions regarding the procedure. (11) In some cases, these statutes have even gone so far as to force doctors to provide information in a way that is not only undesirable, but also potentially misleading or inaccurate. To make matters worse, rather than examining such statutes to determine whether they have any scientific or medical basis, courts, including the Supreme Court, have become increasingly deferential to the legislature, even in the face of blatant misstatements of fact. (12) As a result, instead of enhancing informed consent by providing a more educated patient base, these statutes undercut the traditional goals of the doctrine in favor of greater legislative say in patient action. (13)

This Note argues that there is no place for medically unfounded statutes that interfere with the doctor-patient relationship by posing as requirements for informed consent. Although it is questionable whether legislatures should be creating statutory informed consent requirements for specific procedures under any circumstances, statutes without scientific foundation are especially problematic. The Note will proceed in four parts. Part I will provide an overview of the history of informed consent, along with a discussion of some concerns raised by specific informed consent statutes. Part II will provide a discussion of the seminal cases that inform judicial interpretation of these statutes in the abortion context. Part III will look at the more controversial cases and statutes that have arisen in the wake of Gonzales v. Carhart. Finally, Part IV will propose a more stringent standard of review to be used by courts in evaluating contested informed consent legislation. The proposed standard of review will incorporate a closer examination of the scientific foundation underlying specific informed consent statutes that gives greater deference to the views of the scientific and medical communities at large, rather than deferring to legislative determinations of medical fact. Such review is imperative to maintain the integrity of informed consent given legislatures' increasing proclivity to misuse scientific or medical information to achieve a particular, typically political, end.

1. INFORMED CONSENT BY STATUTE: HISTORY AND CONCERNS

   Informed consent came about "to ensure that each patient gets the information she needs to meaningfully consent to medical procedures." (14) It "purported to solve medicine's paternalism," seeking to overcome the fact that "doctors too often dictat[ed] treatments rather than discussing options." (15) Informed consent is often looked at as a patient right; its ultimate goal is "to allow patients to pursue their own conceptions of good" and "to safeguard their own subjective welfare." (16) Though all decisions are, to some extent, affected by outside influences, the informed consent process ideally limits such influences to allow patients the autonomy necessary to best pursue these goals. (17)

   Courts have been largely responsible for creating concrete requirements for physicians obtaining patient informed consent. (18) State legislatures have played a relatively minor role, in many cases merely codifying the common law requirements. (19) Their combined efforts have created two prevailing requirements: "the historical requirement that physicians obtain patients' consent before proceeding with treatment, and the more recent requirement that physicians disclose such information to patients as will enable them to participate knowledgably in making decisions about treatment." (20) The ultimate goal is to create a process that provides patients with all material information regarding the nature of the procedure, its risks, alternatives, and anticipated benefits. While laws embodying these requirements generally leave it to physicians to determine the appropriate level of disclosure, (21) a few statutes do require specific disclosures for certain, extremely serious risks generally recognized as associated with a given procedure. (22)

   In a few contexts, more specific statutory informed consent requirements have come about largely to address perceived disconnects in communication between physicians and their patients. Legislators working directly or indirectly (23) to enact specific informed consent statutes often do so out of concern that, for certain procedures, physicians simply are not providing their patients with all of the necessary information.

   Breast cancer statutes, for example, came about in response to perceived physician overuse of the radical mastectomy and underuse of breast-conserving surgery (also known as lumpectomy) when treating early-stage breast cancer. (24) The statutes generally require physicians to give patients specific information by providing comprehensive brochures, creating an affirmative duty for physicians to orally disclose certain treatment alternatives, or both. (25) Whether written or oral, the mandatory disclosures usually consist of an objective discussion of the advantages and disadvantages of the various treatment options, and typically do not recommend one form of treatment over another. (26)

   The breast cancer statutes have had, at best, marginal success. Though intended to address a lack of proper communication between patients and physicians, many of them instead have "gummed up the works even further by giving cookie-cutter, often lackluster, medical advice...." (27) While the laws certainly increase the likelihood that patients will receive more comprehensive information about their treatment options, it is not clear that this flood of information actually benefits patients in any significant way. The information required by these statutes, especially in brochures, varies significantly in terms of relevance, especially for patients whose breast cancer is at an early stage. (28) Coupled with research demonstrating notable differences in how patients absorb and respond to information from their physicians, this creates a significant possibility "that legislation on disclosure of treatment options may complicate the decision-making process, rather than enhance it, by imposing a decision-making style that may be inappropriate for a majority of breast cancer patients." (29) Inundating patients with information in this way also assumes that those patients want the information in the first place, which is not always the case. (30)

   Specific informed consent statutes related to abortion have gone even further astray from the original principles of informed consent. Like the breast cancer statutes, these also attempt to inundate patients with information regarding the procedure through oral physician disclosures or state-sponsored materials. (31) Unlike the breast cancer statutes, however, the goal is not always to provide comprehensive and objective knowledge. On the contrary, these statutes are transparently in place to deter women, if at all possible, from choosing abortion. Abortion informed consent statutes require disclosure of specific risks in a way that is unlike the risk disclosure required for any other medical procedure. (32) Most problematically, some of these enumerated risks have little or no scientific basis. (33) Unlike the breast cancer statutes which, though possibly...