Federally mandated informed consent: has government gone too far?

• Author: McKenzie, Linda P.

1. INTRODUCTION II. ETHICAL IMPLICATIONS OF INFORMED CONSENT III. LEGAL IMPLICATIONS OF INFORMED CONSENT LAWS IV. FEDERAL ABORTION LEGISLATION A. Partial-Birth Abortion Ban Act B. Unborn Child Pain Awareness Act of 2005 C. Potential Impact of the Unborn Child Pain Awareness Act V. INFORMED CONSENT LAWS A. Planned Parenthood of Central Missouri v. Danforth B. Franklin v. Fitzpatrick C. Freiman v. Ashcroft D. Leigh v. Olson E. Charles v. Caroy F. Planned Parenthood of Southeastern Pennsylvania v. Casey G. Summit Medical Center of Alabama, Inc. v. Siegolman VI. THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION ARTICLE VII. CONCLUSION I. INTRODUCTION

   On April 17, 2007, the United States Supreme Court handed down a long awaited opinion concerning the constitutionality of a law banning a single, specific abortion procedure. (1) The Partial-Birth Abortion Ban Act (the Act) criminalized a surgical procedure known as "intact D & E" or "D & X" [hereafter D & X]. (2) The method, which is extremely rare and used only after the first trimester of pregnancy, is known outside of the medical community as "partial-birth abortion." (3)

   In the months of litigation leading up to the Supreme Court's decision to review the Act, opponents had expressed two primary concerns. First, the Act lacked an exception for the health of the mother. The Supreme Court mandated such an exception in Roe v. Wade and reaffirmed its position numerous times, most recently in Ayotte v. Planned Parenthood of Northern New England. (4) Second, while proponents claimed it applied only to D & X, it was actually broad enough to include all surgical techniques used after thirteen and one third weeks of gestation, thus, imposing an undue burden on women undergoing abortion after that point.

   Three federal districts courts agreed with those challenging the Act. The decisions of these courts were upheld by the circuit courts which reviewed the Partial-Birth Abortion Ban Act of 2003. (5) For guidance, all of the courts reviewing the Act relied on a 2000 Supreme Court opinion finding almost identical language in a Nebraska law to be unconstitutional. (6) Surprisingly, the Supreme Court agreed to review two of the circuit court cases.

   Before the Supreme Court accepted certiorari, in what appeared to be no more than an attempt to circumvent the judicial system, the 109th United States Congress considered a new abortion measure. If passed, the Unborn Child Pain Awareness Act would have forced abortion providers to deliver a scripted message to women requesting abortion services. (7) Under this legislation, physicians violate the law unless they inform patients who have attained thirteen and one third weeks of pregnancy that "the process of being killed in an abortion will cause the unborn child pain." (8) Sponsors claimed that the bill merely required "informed consent" but opponents contended that the language was meant to dissuade women from undergoing second trimester abortions. Congress was also criticized for choosing physicians to deliver the government's message about fetal pain, a topic on which the medical community has not reached a consensus.

   Laws mandating disclosure of particular information are known as informed consent laws. They exist primarily in the area of reproductive health and most often apply to women seeking abortion. This article discusses the legal and ethical issues that arise when lawmakers decide what patients must be told before they can access certain medical procedures.

   Part II examines some of the ethical implications of informed consent laws. Physicians have a duty to obtain a patient's informed consent before acting. (9) The duty to inform arises from the principle of individual autonomy. (10) In the past, physicians were sometimes accused of withholding material information from patients. This paternalism was justified on the ground that the patient would not want to know all of the negative or unpleasant facts. As a result of litigation, legislation, and a change in public perception about the appropriate balance in the doctor-patient relationship, physician paternalism has given way to patient self-determination. (11)

   Part III discusses legal concerns raised by informed consent laws, These include the First Amendment free speech rights of physicians (12) and patients' right to obtain their physicians' advice and counsel without government interference. (13) This article examines two United States Supreme Court cases that addressed these aspects of informed consent and the implications of the Court's holdings for fetal pain informed consent legislation. (14)

   Part IV reviews two recent pieces of federal legislation with the potential to significantly affect abortion practice and the lives of women who seek abortion services. The first law, the Partial-Birth Abortion Ban Act, criminalized two common abortion procedures. (15) Although signed into law in 2003, (16) implementation of the Act was enjoined by three federal courts. (17) Ultimately, the decisions of the Court of Appeals for the Eighth and Ninth Circuits were reversed by the United States Supreme Court. (18)

   Prior to the 2007 Gonzales v. Carhart decision, members of Congress introduced a second bill aimed at eliminating mid-trimester surgical abortions. The Unborn Child Pain Awareness Act would criminalize the performance of abortions after thirteen-and-one-third weeks of pregnancy without first informing the patient that the fetus would experience profound pain. (19) Additionally, it required the abortion provider to offer the option of fetal anesthesia. (20) Judging from the title, it was not readily apparent that the Unborn Child Pain Awareness Act was aimed at curbing late-term abortion but the surrounding circumstances suggested just that. This article argues that Congress's use of this back door approach to achieving its objective actually undermined its credibility and its chance for success.

   Part V briefly reviews the cases that identified and defined the constitutional right to an abortion. (21) It then discusses cases where courts considered the constitutionality of informed consent laws and compares the reasoning of those courts to the arguments likely to be raised in any challenge to the federal Unborn Child Pain Awareness Act of 2005.

   Part VI summarizes the findings of a team of physicians at the University of California at San Francisco, concluding that fetal perception of pain is unlikely prior to twenty-nine weeks gestation. Reaction to the article, which appeared in the August 2005 issue of the Journal of the American Medical Association, was positive for the most part. (22) Some physicians as well as pro-life advocates, however, criticized the article as no more than an effort to discredit fetal pain legislation.

2. ETHICAL IMPLICATIONS OF INFORMED CONSENT

   "[I]t is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie." (23)

   Informed consent encompasses the principle that an individual is entitled to decide what will happen to her body. Furthermore, based on this individual right physicians incur a duty to inform each patient about the potential risks and benefits of any recommended medical treatment. (24) The physician's duty arises from the concept, "fundamental in American jurisprudence, that '[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body...." (25)

   In the seminal informed consent case, Cantebury v. Spence, the Court of Appeals for the D.C. Circuit held that a physician has a duty to communicate the specific information that a patient needs to make an informed decision. (26) Other courts judged the extent of the physician's duty by what prudent physicians disclosed in similar circumstances. (27) The Cantebury court rejected this reasoning, finding that neither the obligation to disclose nor the scope of disclosure originates from a community standard. (28) Instead, the physician's duty and the scope of his obligation to inform originate from the patient's right of self-determination. (29) That right cannot be exercised effectively unless the patient possesses "enough information to enable an intelligent choice." (30) Thus, the scope of the physician's duty requires disclosure of information that the patient would find material to making a treatment decision, to weighing the risks associated with having or not having the treatment, and to decide on any alternative treatment. (31)

   The Cantebury court recognized that there are two instances where a physician holds the privilege not to disclose. (32) The first arises in an emergency situation where a patient is incapable of consent. (33) The second situation is one where the disclosure may be so detrimental to the patient that it is medically contraindicated. (34) The second exception provides leeway for the physician to determine, within limits, what is in a patient's best interests to know and to tailor disclosure to a patient's unique circumstance. (35) This exception has been invoked in the context of informed consent for abortion. Some physicians feel that giving a detailed account of the effect of abortion on the fetus is harmful to the health interests of the patient. (36)

   There are three important public policy reasons behind designating to physicians responsibility for obtaining the informed consent of patients. First, physicians have knowledge and experience beyond that of the average patient, putting them in a position to provide information about disease processes, risks and benefits of potential treatments, and prognoses. (37) Second, the personal and intimate nature of the doctor-patient relationship invites the patient to rely on the advice and expertise of the physician. (38) Third, the idea that physicians owe patients a duty of care is already established in tort law, such that failure to obtain a patient's informed consent breaches that duty...