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MODERNIZING INFORMED CONSENT: EXPANDING THE

BOUNDARIES OF MATERIALITY
Nadia N. Sawicki*

INTRODUCTION

The doctrine of informed consent is now so firmly entrenched in


medical practice and legal theory that it is easy to forget how recent its
origins are. It was not until the early 1960’s that most medical and legal
professionals began to recognize that malpractice liability could attach to a
physician’s failure to properly inform her patient of the risks and benefits of
proposed clinical treatment.1
In the past fifty years, however, little has changed. Certainly,
physicians have become far more sensitive to issues of patient autonomy;
greater attention is being paid to health literacy; and shared conversation
rather than one-sided disclosure is now considered the optimal model for
obtaining informed consent. But the substantive scope of clinicians’
disclosure duties under the doctrine of informed consent has remained
essentially unchanged. With very few exceptions, disclosures in clinical
practice are limited to information that is considered material from a purely
medical perspective: the patient’s diagnosis and prognosis, the nature of the
proposed treatment, the treatment’s risks and benefits, and any reasonable
alternative treatments.2
It is time to reconsider the merits of this basic model.
Contemporary understandings of the nature of human decision-
making support the finding that patients choosing between various types of
medical treatment do so by considering many factors, not just the
physiological consequences of treatment. Most notably, a wealth of recent
literature about values-based decision-making and preference-sensitive care
demonstrates that many patients’ medical decisions are driven by personal

*
Associate Professor, Loyola University Chicago School of Law, Beazley Institute for
Health Law and Policy.
1
See generally, RUTH R. FADEN AND TOM L. BEAUCHAMP, A HISTORY AND THEORY
OF INFORMED CONSENT (Oxford University Press, 1986), at 88-91; JAY KATZ, THE SILENT
WORLD OF DOCTOR AND PATIENT (Johns Hopkins University Press, 2002), at 59-80.
2
See Parts II-B and II-C, infra.
2 Modernizing Informed Consent

preferences about risk-taking, cost, the prevention of suffering, and the


value of extending life.3
While debates about whether informed consent should incorporate
non-medical facts that patients consider relevant have been taking place for
decades, these debates have not resulted in any large-scale changes in
medical practice or tort liability. The groundswell of managed care in the
late 1980’s and 1990’s, for example, triggered a nationwide discussion
about physicians’ obligations to disclose the financial incentives guiding
their treatment decisions.4 Prominent cases like Johnson v. Kokemoor,5
Moore v. University of California,6 and Estate of Behringer v. Princeton7
led to questions about whether a physician’s personal characteristics –
whether her qualifications,8 financial interests in medical research,9 or HIV
status10 – ought to be disclosed as part of the informed consent process.11

3
The phrase “preference-sensitive care” was coined by Jack Wennberg, whose
influential research on practice variations led to the development of modern models of
shared decision-making. See generally, John E. Wennberg, Unwarranted Variations in
Healthcare Delivery: Implications for Academic Medical Centres, 325(7370) BRITISH
MED. J. 961 (2002) (demonstrating that many variations in clinical practice “cannot be
explained by type or severity of illness or by patient preferences”); Jaime Staples King and
Benjamin W. Moulton, Rethinking Informed Consent: The Case for Shared Medical
Decision-Making, 32 AM. J. L. & MED. 429, at 430-431 (2006) (discussing research on
variability in patient values and preferences, and the implications for medical practice).
4
See, e.g., E. Haavi Morreim, Economic Disclosure and Economic Advocacy: New
Duties in the Medical Standard of Care, 12 J. L. & MED. 275 (1991); Susan M. Wolf,
Toward a Systemic Theory of Informed Consent in Managed Care, 35 HOUSTON L. REV.
1631(1999); Joan H. Krause, Reconceptualizing Informed Consent in an Era of Health
Care Cost Containment, 85 IOWA L. REV. 261 (1999); Mark Hall, A Theory of Economic
Informed Consent, 31 GA. L. REV. 511 (1997).
5
Johnson v. Kokemoor, 545 N.W.2d 495 (Wis. 1996).
6
Moore v. Regents of Univ. of California, 793 P.2d 479, 485 (Cal. 1990)
7
Estate of Behringer v. Medical Center at Princeton, 592 A.2d. 1251 (N.J. Super. Ct.
1991).
8
See, e.g., Richard A Heinemann, Pushing the Limits of Informed Consent: Johnson v.
Kokemoor and Physician-Specific Disclosure, 1997 WISC. L. REV. 1079 (1997); Richard J.
Veerapen, Informed Consent: Physician Inexperience is a Material Risk for Patients, 35(3)
J. L. MED. & ETHICS 478 (2007); Emmanuel O. Iheukwumere, Doctor, Are You
Experienced? The Relevance of Disclosure of Physician Experience to a Valid Informed
Consent, 18 J. CONTEMP. HEALTH L. & POL'Y 373 (2001-2002); Aaron D. Twerski and Neil
B. Cohen, The Second Revolution in Informed Consent: Comparing Physicians to Each
Other, 94 NORTHWESTERN U. L. REV. 1 (1999).
9
See, e.g., Joseph M. Healey, Jr. and Kara L. Dowling, Controlling Conflicts of
Interest in the Doctor-Patient Relationship: Lessons from Moore v. Regents of the
University of California, 42 MERCER L. REV. 989 (1990); Jeffrey A. Potts, Note: Moore v.
Regents of the University of California, 86 NORTHWESTERN U. L. REV. 453 (1992).
10
See, e.g., Michelle Wilcox DeBarge, The Performance of Invasive Procedures by
Modernizing Informed Consent 3

More recently, increased public awareness of the dramatic differences in the


cost of medical treatment across various health care settings12 has led some
commentators to suggest that patients cannot grant truly informed consent
without knowing the cost of their proposed treatment.13
As a result of these debates, there is already a wealth of academic
literature analyzing the merits of requiring physicians to disclose their
financial conflicts of interests, their qualifications, their HIV status, and,
more recently, the price of treatment.14 Beyond these very narrow contexts,
however, there is little discussion and no consensus about what constitutes
“materiality” in informed consent more broadly, or whether there is any
justification for expanding the doctrine of informed consent to include
information that may be relevant to patients but falls outside the traditional
scope of medical materiality.15

HIV-Infected Doctors: The Duty to Disclose Under the Informed Consent Doctrine, 25
CONN. L. REV. 991 (1992); Theodore R. LeBlang, Obligations of HIV-Infected Health
Professionals to Inform Patients of their Serological Status: Evolving Theories of Liability,
27 JOHN MARSHALL L. REV. 317 (1993); Lawrence Gostin, HIV‐Infected Physicians and
the Practice of Seriously Invasive Procedures, 19(1) HASTINGS CENTER REPORT 32 (1989).
11
See generally, Mary Ann Bobinski, Autonomy and Privacy: Protecting Patients
from Their Physicians, 55 U. PITTSBURGH L. REV. 291 (1994); Marc D. Ginsberg, Informed
Consent: No Longer Just What the Doctor Ordered?, 15 MICH. STATE U. J. MED. & LAW
18 (2010).
12
Public attention was drawn to the high (and variable) costs of American medical
care due to a series of very high-profile articles published by the New York Times in 2013-
2014 as part of a series titled Paying Till it Hurts, available at
http://www.nytimes.com/interactive/2014/health/paying-till-it-hurts.html. See also
Elizabeth Rosenthal, The Price for a Hip Replacement? Many Hospitals Are Stumped,
Research Shows, New York Times (Feb. 12, 2013), A21 (discussing research findings
reported in J. A. Rosenthal, X. Lu, and P. Cram, Availability of Consumer Prices from US
Hospitals for a Common Surgical Procedure, 173(6) JAMA INTERNAL MEDICINE 427
(2013)).
13
See, e.g., Peter A. Ubel, Doctor, First Tell Me What It Costs, New York Times
(Nov. 4, 2013), A25; Alicia Hall, Financial Side Effects: Why Patients Should be Informed
of Costs, 44(3) HASTINGS CENTER REPORT 41 (May-June 2014); Kevin R. Riggs and Peter
Ubel, Overcoming Barriers to Discussing Out-of-Pocket Costs With Patients, 174(6)
JAMA INTERNAL MEDICINE 849 (2014), Peter A Ubel, Amy P. Abernethy, and S. Yousuf
Zafar, Full Disclosure—Out-of-Pocket Costs as Side Effects, 369(16) NEW ENGLAND J.
MED. 1484 (2013).
14
See references at notes 4-13, supra.
15
In 1995, after two state courts decided informed consent cases dealing with
information arguably outside the scope of medical materiality, Judith Daar wrote an
influential article discussing the potential expansion of the materiality doctrine. Judith
Daar, Informed Consent: Defining Limits Through Therapeutic Parameters, 16 WHITTIER
L. REV. 187 (1995) (discussing the “therapeutic limitation” on informed consent in light of
Arato v. Avedon and Faya v. Almaraz). However, with the exception of Daar’s article,
4 Modernizing Informed Consent

This Article begins, in Part II, by explaining the ethical and legal
theories that form the basis of the doctrine of informed consent, and
identifying the limited guidance provided by courts in defining materiality
for the purposes of informed consent. It demonstrates that common law has
traditionally limited the scope of disclosure to medically material facts, but
makes the normative argument that the ethical foundations of informed
consent doctrine (together with contemporary understandings of patient
decision-making processes) would support broader disclosure duties.
In Part III, the Article develops a descriptive taxonomy of non-
medical disclosures that are relevant to patient decision-making and have
been proposed – by litigants, policymakers, and scholars – as potentially
suitable for inclusion within the process of informed consent. These include
not only disclosures about physicians’ financial conflicts of interest,
personal risk factors, and cost of treatment, but also disclosures about
physicians’ other personal characteristics, practice patterns, and
conscientious commitments; about social and societal implications of
treatment (as with prenatal genetic testing); about risks to third parties (as in
the cases of organ donation and abortion); and about government and third-
party resources available to assist patients (such as adoption resources and
TANF assistance).
Part IV of the Article crafts a normative framework for expanding
the doctrine of materiality in informed consent. It recognizes that while
ethical theories of decisional autonomy would likely support broader
disclosure duties, practical limitations restrict the feasibility of a significant
expansion. Moreover, while expanding disclosure obligations would likely
benefit patients, doing so might be unreasonable for the physicians who
bear the primary burden of identifying and sharing material non-medical
information, as well as the secondary burden of tort liability for non-
disclosure. Part IV argues that the legal doctrine of informed consent in
clinical practice can and should be expanded to include some non-medical
information, subject to the following limitations: the disclosed information

most other commentary examining the potential expansion of informed consent on a larger
scale has only addressed the disclosure of physician-specific information – not the other
categories of information identified in Part III of this Article. See, e.g., Bobinski, supra
note 11 (discussing statutory and common law disclosure duties relating to provider
characteristics and financial conflicts of interest); Ginsberg, supra note 11 (discussing
expansion of informed consent doctrine to include physician-specific information);
Twerski & Cohen, supra note 8 (discussing disclosure of information relating to physician
qualifications).
Modernizing Informed Consent 5

must be material to the reasonable patient, within the physician’s


knowledge and expertise, and its disclosure must not violate public policy.
Required disclosures based on the physician-expertise standard
would include not only medical information about the proposed treatment,
but also some non-medical information about the physician’s own
characteristics (such as her experience, financial conflicts of interest, health
status, etc.); information about a treatment’s medical impact on third parties
(in the case of surrogacy and organ donation, for example); any specialized
knowledge the physician might have about the real-world implications of
living with disability; as well as the cost of treatment in those very limited
areas of medical practice where cost information is readily known (like
psychiatry and plastic surgery). However, many categories of information
that some commentators believe ought to be disclosed will not be captured
by this expanded definition of materiality. Information about the cost of
treatment will be excluded, at least in most practice areas; as will physician-
specific disclosures that implicate privacy or policy concerns; and
information about the social, ethical, legal, and privacy implications of
treatment. Some categories of disclosure that are currently required by law –
most notably, information about social and financial support resources
available to women seeking abortions – would also be excluded.
We live in an era where patients’ medical decisions are often driven
by factors that were not contemplated (or were simply not relevant) when
the doctrine of informed consent was first developed. To bring informed
consent law into the 21st century, we must re-evaluate the under-theorized
doctrine of materiality, and recognize that the ethical principles of
decisional autonomy that underlie informed consent demand a broader
understanding of materiality. In offering both a descriptive taxonomy of
non-medically material disclosures as well as a normative proposal for
expanding the doctrine of informed consent, this author hopes to assist
readers in interpreting existing legal precedent, and in setting normative
goals for future policymaking and clinical practice.

I. DOCTRINAL FOUNDATIONS OF INFORMED CONSENT AND


MATERIALITY

The ethical and legal doctrines of informed consent to medical


treatment arose in the mid-20th century, partly in response to growing
patient dissatisfaction with the paternalistic standards of the medical
6 Modernizing Informed Consent

profession.16 As the medical community began to recognize the value of


patient autonomy and integrate conversations about patient choice into the
treatment process, American law followed suit. By the late 1960’s and
early 1970’s, most courts recognized the failure to obtain informed consent
as a form of medical negligence, and were willing to impose tort liability on
physicians who breached this duty.17 In defining the scope of the informed
consent duty, courts uniformly concluded that physicians have a legal
obligation to inform patients of material information about a proposed
course of treatment, which includes its risks and benefits as well as those of
any alternative treatments.
This common law standard for informed consent soon became
entrenched in both legal doctrine and responsible medical practice.
However, perhaps because there was such widespread consensus across
jurisdiction about the scope of required disclosures, neither courts nor
commentators devoted much attention to the question of whether the
materiality standard might be interpreted more broadly.
In this Part, I explain the ethical foundations of the doctrine of
informed consent, and provide a brief history of how this doctrine
manifested itself in early common law.

A. Ethical Foundations: Decisional Autonomy

The doctrine of informed consent is grounded in the ethical principle


of patient autonomy.18 Patients have a right to control their own bodies, and
16
See generally, KATZ, supra note 1. Informed consent doctrine in the research ethics
context arose somewhat earlier than in the clinical context, but tracked it through the
1960’s and 1970’s. Discussions about informed consent to human subjects research began
in earnest as a result of the Nuremberg trials of 1945-1946; they then continued through
Henry Beecher’s 1966 article in the New England Journal of Medicine about ethical
violations in American research, the 1972 revelation of the Tuskegee syphilis trials, and
ultimately the Office of Human Subjects Research Protection’s 1979 publication of the
Belmont Report.
17
While the modern doctrine of informed consent is grounded in negligence
principles, it originated as a cause of action for battery. See generally, JESSICA W. BERG,
PAUL S. APPELBAUM, CHARLES W. LIDZ, LISA S. PARKER, INFORMED CONSENT: LEGAL
THEORY AND CLINICAL PRACTICE (Second Edition) (Oxford University Press, 2001), at 41-
44; BARRY FURROW et al, HEALTH LAW (Second Edition) (West, 2000), at 310-313.
18
See generally, GERALD DWORKIN, THE THEORY AND PRACTICE OF AUTONOMY
(Cambridge University Press, 1988), at 100-120; FADEN AND BEAUCHAMP, supra note 1, at
7-9; TOM L. BEAUCHAMP AND JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS
(Sixth Edition) (Oxford University Press, 2008), at 103-105, 117-120; BERG et al, supra
note 17, at 22-24.
Modernizing Informed Consent 7

to make free and unencumbered choices about the medical interventions


imposed on their bodies. While the theory of decisional autonomy is
grounded in Kantian deontological values (the notion that the exercise of
autonomy is a good in and of itself, regardless of its consequences),
autonomous decision-making often has utilitarian benefits as well – that is,
allowing patients to make autonomous choices ultimately promotes their
welfare by leading to objectively better choices.19 Furthering autonomy
requires recognizing the patient’s subjective goals and values, and
providing the patient with the information needed to make a coherent
decision in accordance with these goals and values.20
Autonomous decision-making requires the satisfaction of a variety
of conditions, including capacity, voluntariness, and factual
understanding.21 In the context of medical treatment, however, patients are
often unable to make informed choices because they lack the information
necessary to understand their options. Physician disclosure is thus a
necessary component for satisfying the conditions of autonomous decision-
making in medical care.22 Beyond general reference to “materiality” or
“relevance,” however, ethical theories of informed consent rarely provide
specific guidance about the substantive information that ought to be
disclosed as part of the consent process.23 Indeed, medical ethicists

19
DWORKIN, supra note 18, at 111-112 (discussing both intrinsic and utilitarian
arguments for autonomous medical decision-making).
20
See Tom L. Beauchamp, Autonomy and Consent, in THE ETHICS OF CONSENT:
THEORY AND PRACTICE, FRANKIN G. MILLER AND ALAN WERTHEIMER, EDS. (Oxford
University Press, 2010), at 62 (recognizing that the principle of respect for autonomy
demands that we “respect an autonomous agent’s right to control his or her affairs in
accordance with personal values and beliefs.”); BERG et al, supra note 17, at 24 (noting
that autonomous and informed decision-making promotes subjective well-being);
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research, Making Health Care Decisions: The Ethical and Legal Implications
of Informed Consent in the Patient-Practitioner Relationship (Oct. 1982), at 42-43 (noting
the importance of informed consent in achieving patients’ subjective goals).
21
See generally, BEAUCHAMP AND CHILDRESS, supra note 18, at 120-121; BERG et al,
supra note 17, at 65-70.
22
BEAUCHAMP AND CHILDRESS, supra note 18, at 121-122.
23
See, e.g., BEAUCHAMP AND CHILDRESS, supra note 18, at 121 (noting that health
care professionals must disclose “those facts or descriptions that patients or subjects
usually consider material in deciding whether to refuse or consent to the proposed
intervention or research” as well as “information the professional believes to be material”);
FADEN AND BEAUCHAMP, supra note 1, at 9 (referring to the question of what kinds of
information must be disclosed to facilitate autonomous decision-making “remain[s]
unsettled”) and 308 (identifying a “core disclosures” those facts that patients and health
care professionals believe to be “material”). The American Medical Association’s Council
on Ethical and Judicial Affairs’ opinion on the requirements of informed consent is
8 Modernizing Informed Consent

frequently criticize the law’s emphasis on defining the substantive scope of


required disclosure; instead, they argue, the ethical duty to obtain informed
consent ought to be context-specific, focusing on the patient’s actual
understanding rather than the physician’s satisfaction of rote disclosure
requirements.24 In framing the ideal informed consent process as an
ongoing process of shared decision-making and conversation,25 medical
ethicists recognize that there is no single disclosure standard that will
suffice for all doctors and all patients.26 Thus, they may see less need to
delineate the specific boundaries of what ought to be disclosed – at least as
compared to attorneys and their clients, who typically require greater clarity
about substantive disclosure standards and the boundaries of tort liability.

B. Legal Foundations: The Common Law Duty of Informed Consent

The modern legal doctrine of informed consent allows a patient who


suffers injury as a result of a medical procedure’s undisclosed risks to
recover in tort from the physician who failed to adequately disclose those
risks. To prevail in a typical informed consent action, the patient must
demonstrate that (1) her physician breached a duty to disclose a material

likewise vague; it requires the disclosure of “all relevant medical information,” but notes
that “quantity and specificity of this information should be tailored to meet the preferences
and needs of individual patients.” American Medical Association, Council on Ethical and
Judicial Affairs, Opinion 8.08: Informed Consent (issued March 1981; updated November
2006) (hereafter, AMA Opinion 8.08).
24
See, e.g., FADEN AND BEAUCHAMP, supra note 1, at 305-308 (criticizing the
disclosure standards of informed consent law, and arguing that informed consent ought to
focus on communication aimed at achieving “substantial shared understanding,” rather than
relying simply on “core disclosures”); Beauchamp, Autonomy and Consent, supra note 20,
at 57-58 (“Physicians who obtain consent under institutional criteria can fail – and often do
fail – to meet the more rigorous standards of an autonomy-based model.”); Steven Joffe
and Robert Truog, Consent to Medical Care: The Importance of Fiduciary Context, in
MILLER AND WERTHEIMER, EDS., supra note 20, at 368-369 (noting that a single set of
disclosure standards may not be able to satisfy both legal and ethical standards of informed
consent). Some legal scholars share this concern as well. See, e.g., Dayna Bowen Matthew,
Race, Religion, and Informed Consent – Lessons from Social Science, 36(1) J. L. MED. &
ETHICS 150, 168 (Spring 2008) (noting that “[t]he error of informed consent law has been
in oversimplifying the complexity of the relationship between physician and patient by
regulating the disclosure rather than the relationship”); Jay Katz, Informed Consent, A
Fairy Tale?, 39 U. PITT. L REV 137, 173 (1977) (noting the impossibility of
“promulgat[ing] an informed consent doctrine which articulates the extent of
communication required for all medical encounters[.]”).
25
King and Moulton, supra note 3.
26
AMA Opinion 8.08, supra note 23 (noting the necessity of tailoring disclosure
requirements to individual patients).
Modernizing Informed Consent 9

risk associated with a medical procedure; (2) that the reasonable patient
would more likely than not have opted not to undergo the procedure had she
known of the undisclosed risk; (3) that the patient suffered a compensable
injury as a result of her decision; (4) and that the patient’s injury was in fact
caused by the undisclosed risk.27 The disputed issue in the vast majority of
informed consent cases – and the issue that legal and medical scholars
debate with greatest intensity – is the substantive scope of the disclosure
duty.28
The scope of the physician’s duty varies depending on the
jurisdiction in which she practices. In the United States, jurisdictions are
more or less evenly divided between a patient-based standard and a
physician-based standard for identifying the information that must be
disclosed as part of the informed consent process.29
The physician-based standard, which was more prevalent in the
early history of informed consent, defines the scope of disclosure by
reference to what a reasonable physician would customarily disclose.30 The
Kansas Supreme Court’s 1960 decision in Natanson v. Kline (which is still
cited by some courts today) held that a physician has a duty to “assure that
an informed consent of the patient is obtained,” but that this duty is limited
to “those disclosures which a reasonable medical practitioner would make
under the same or similar circumstances.”31

27
Patients may also bring informed consent cases associated with decisions not to
pursue medical treatment or testing – for example, a patient who chooses not to undergo a
Pap smear because her physician failed to adequately disclose the risks of inaction may
bring a tort suit if she suffers injury as a result of the ill-informed decision. Truman v.
Thomas, 611 P.2d 902 (Cal. 1980).
28
As Peter Schuck wrote, “Everyone, it seems, favors the principle of informed
consent; it is ‘only’ the specific details and applications of the doctrine that arouse serious
debate.” Peter H. Schuck, Rethinking Informed Consent, 103 Yale L. J. 899, 902 (1994).
29
FURROW et al, supra note 17, at 314 (noting that “more than twenty-five states”
have adopted a physician-based standard, either by judicial decision or by statute, but that
the patient-based standard is now “approaching a majority position”); King and Moulton,
supra note 3, at Appendix A. For a more thorough explanation of the history of and
distinction between the two standards, see BERG et al, supra note 17, at 46-52; FURROW et
al, supra note 17, at 313-314; FADEN AND BEAUCHAMP, supra note 1, at 30-34.
30
Under the physician-based standard, expert testimony is required to establish the
scope of required disclosures. See, e.g., Hamilton v. Bares, 678 N.W.2d 74 (Neb. 2004);
Aronson v. Harriman, 901 S.W.2d 832 (Ark. 1995); Roark v. Allen, 633 S.W.2d 804, 809
(Tex. 1982); Roberts v. Young, 119 N.W.2d 627 (Mich. 1963).
31
Natanson v. Kline, 350 P.2d 1093, 1106 (Kan. 1960), decision clarified on denial of
reh'g, 354 P.2d 670 (Kan. 1960).
10 Modernizing Informed Consent

The physician-based standard has been widely criticized on the


grounds that it does not accurately reflect the autonomy-based principles
underlying the doctrine of informed consent. In Canterbury v. Spence,
perhaps most broadly-cited informed consent case in American
jurisprudence, the U.S. Court of Appeals for the District of Columbia
Circuit rejected the physician-based standard, noting that the “root premise”
of informed consent doctrine is “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. . . .”32
Accordingly, the court held, it is “the patient's right of self-decision [that]
shapes the boundaries of the duty to reveal.”33
Under the patient-based standard established in Canterbury and
adopted by numerous courts since then, the scope of the disclosure duty is
defined by reference to the reasonable patient’s needs and expectations. Key
to the patient-based standard of disclosure is the question of what
information a reasonable patient would find “material.”34 According to the
court in Canterbury, a risk qualifies as material when a “reasonable person
… would be likely to attach significance to the risk or cluster of risks in

32
Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir. 1972) (citing Schloendorff v.
Society of New York Hospital, 105 N.E. 92, 93 (N.Y. 1914))
33
Id. at 786-87. See also Wheeldon v. Madison, 374 N.W.2d 367, 374 (S.D. 1985)
(holding that “the right to know - to be informed - is a fundamental right personal to the
patient and should not be subject to restriction by medical practices that may be at odds
with the patient's informational needs.”); Sard v. Hardy, 379 A.2d 1014, 1021 (Md. 1977)
(holding that “protection of the patient's fundamental right of physical self-determination
[is] the very cornerstone of the informed consent doctrine [and] mandates that the scope of
a physician's duty to disclose therapeutic risks and alternatives be governed by the patient's
informational needs”); Largey v. Rothman, 540 A.2d 504, 508 (N.J. 1988) (identifying as
one of the reasons for rejecting the physician-based standard “the notion that the
physician's duty of disclosure ‘arises from phenomena apart from medical custom and
practice’: the patient's right of self-determination”); Cross v. Trapp, 294 S.E.2d 446, 455
(W. Va. 1982) (holding that liability under the patient-based standard depends on “the
reasonableness of the physician's disclosure or nondisclosure in terms of what the
physician knows or should know to be the patient's informational needs”).
34
Canterbury v. Spence, 464 F.2d 772, at 787 (D.C. Cir. 1972) (holding that
physicians have a common law duty to disclose all risks “material to the [patient’s]
decision”); Wheeldon v. Madison, 374 N.W.2d 367, 375 (S.D. 1985) (“Materiality,
therefore, is the cornerstone upon which the physician's duty to disclose is based. “);
FADEN AND BEAUCHAMP, supra note 1, at 32 (referring to materiality as the “legal litmus
test” for determining extent of disclosure under the reasonable patient standard); Jon R.
Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 NORTHWESTERN U. L.
REV. 628, 637 (1969) (describing materiality as the “traditional legal litmus for measuring
the significance of decision-making).
Modernizing Informed Consent 11

deciding whether or not to forego the proposed therapy.” 35 This definition


of materiality has been widely adopted.36
While the determination of what information counts as “material” is
ultimately one for the jury,37 most courts adopting the patient-based
standard have identified a set of disclosures they consider essential for an
informed decision. This includes substantive information about the patient’s
diagnosis and proposed treatment; the treatment’s risks and benefits;
alternative procedures and their risks and benefits; and the risks and benefits
of taking no action (hereafter referred to as the “standard risk-and-benefit
disclosure”).38 Interestingly, although physician-based jurisdictions reject

35
Canterbury v. Spence, 464 F.2d 772, at 787 (D.C. Cir. 1972).
36
See, e.g., Wilkinson v. Vesey, 295 A.2d 676, 689 (R.I. 1972) (“Materiality may be
said to be the significance a reasonable person, in what the physician knows or should
know is his patient's position, would attach to the disclosed risk or risks in deciding
whether to submit or not to submit to surgery or treatment.”); Wheeldon v. Madison, 374
N.W.2d 367, 371 (S.D. 1985) (“Material information is information which the physician
knows or should know would be regarded as significant by a reasonable person in the
patient's position when deciding to accept or reject a recommended medical procedure.”);
Sard v. Hardy, 379 A.2d 1014, 1022 (Md. 1977) (“A material risk is one which a physician
knows or ought to know would be significant to a reasonable person in the patient's
position in deciding whether or not to submit to a particular medical treatment or
procedure.).
37
Wilkinson v. Vesey, 295 A.2d 676, 688 (R.I. 1972); Downs v. Trias, 49 A.3d 180,
186 (Conn. 2012); Smith v. Weaver, 407 N.W.2d 174, 178 (Neb. 1987).
38
See, e.g., Canterbury v. Spence, 464 F.2d 772, at 787-88 (D.C. Cir. 1972) (“The
topics importantly demanding a communication of information are the inherent and
potential hazards of the proposed treatment, the alternatives to that treatment, if any, and
the results likely if the patient remains untreated.”); Wheeldon v. Madison, 374 N.W.2d
367, 375 (S.D. 1985) (“We deem a reasonable disclosure to be one which apprises the
patient of all known material or significant risks inherent in a prescribed medical
procedure, as well as the availability of any reasonable alternative treatment or
procedures.”); Sard v. Hardy, 379 A.2d 1014, 1020 (Md. 1977) (“This duty to disclose is
said to require a physician to reveal to his patient the nature of the ailment, the nature of the
proposed treatment, the probability of success of the contemplated therapy and its
alternatives, and the risk of unfortunate consequences associated with such treatment”);
Cross v. Trapp, 294 S.E.2d 446, 455 (W. Va. 1982) (adopting the patient-based standard,
and identifying the following as material facts: “(1) the possibility of the surgery, (2) the
risks involved concerning the surgery, (3) alternative methods of treatment, (4) the risks
relating to such alternative methods of treatment and (5) the results likely to occur if the
patient remains untreated.”); Duffy v. Flagg, 905 A.2d 15, 20 (Conn. 2006) (adopting the
patient-based standard, and requiring disclosure of “(1) the nature of the procedure; (2) the
risks and hazards of the procedure; (3) the alternatives to the procedure; and (4) the
anticipated benefits of the procedure.”); Howard v. Univ. of Med. & Dentistry of New
Jersey, 800 A.2d 73, 79 (N.J. 2002) (adopting the reasonably prudent patient standard, and
requiring disclosure of “information concerning the risks of the procedure or treatment, the
alternatives, or the potential results if the procedure or treatment were not undertaken”).
12 Modernizing Informed Consent

the idea that the scope of disclosure should be guided by the patients’
informational needs, states that retain the physician-based standard rely on
the same set of standard risk-and-benefit disclosures when framing the issue
of physician liability.39 Most statutory codifications of informed consent
requirements use similar language, although they vary in their specificity.40
It is worth noting, however, that a minority of courts and legislatures
interpret the informed consent disclosure duty more narrowly. Relying on
Canterbury v. Spence’s language about “the inherent and potential hazards
of the proposed treatment,”41 some courts limit informed consent disclosure
to the purely medical or physiological risks and benefits inherent in a
procedure. Such courts have rejected tort claims alleging physician non-
disclosure of the method by which a procedure is performed (on the
grounds that this does not constitute a risk),42 as well as non-disclosure of
the risk of provider negligence (on the grounds that this risk is not “inherent
in the procedure”).43 Some courts and legislatures have narrowed the

39
See e.g., Natanson v. Kline, 350 P.2d 1093, 1106 (Kan. 1960) decision clarified on
denial of reh'g, 354 P.2d 670 (Kan. 1960) (establishing a physician-based standard of
disclosure, and identifying required disclosures as “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”); Shadrick v. Coker, 963
S.W.2d 726, 732 (Tenn. 1998) (holding that the scope of the disclosure duty depends on
“the usual and customary advice given to patients to procure consent in similar situation,”
and requiring specific disclosure of “the diagnosis or nature of the patient's ailment, the
nature of and the reasons for the proposed treatment or procedure, the risks or dangers
involved, and the prospects for success,” as well as “alternative methods of treatment, the
risks and benefits of such treatment and, if applicable, that the proposed treatment or
procedure is experimental”).
40
Compare, e.g., Tex. Civ. Prac. & Rem. Code Ann. § 74.101 and 104 (requiring
disclosure of the “risks or hazards” involved in a procedure); N.Y. Pub. Health Law §
2805-d (requiring disclosure of “alternatives” and “reasonably foreseeable risks and
benefits”); 40 Pa. Cons. Stat. Ann. § 1303.504 (requiring “a description of a procedure” as
well as disclosure of “risks and alternatives”); Ga. Code Ann. § 31-9-6.1 (West) (requiring
disclosure of (1) diagnosis, (2) the proposed procedure’s “nature and purpose”, (3) the
material risks of “infection, allergic reaction, severe loss of blood, loss or loss of function
of any limb or organ, paralysis or partial paralysis, paraplegia or quadriplegia, disfiguring
scar, brain damage, cardiac arrest, or death.” (4) the procedure’s likelihood of success; (5)
alternative treatments; (6) prognosis if the proposed treatment is rejected).
41
Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972).
42
See, e.g., Tajchman v. Giller, 938 S.W.2d 95 (Tex. App. 1996) (holding that Texas’
informed consent statute did not require disclosure of the particular steps involved in a
procedure, only the “risks or hazards” associated with the procedure); Valles v. Albert
Einstein Medical Center, 805 A.2d 1232, at 1240 (Pa. 2002) (holding that “the manner or
method in which the surgeon performs the proposed procedure is not encompassed within
the purview of the informed consent doctrine.”).
43
See, e.g., Gilmartin v. Weinreb, 735 A.2d 620, at 627 (N.J. Super. 1999) (in a case
Modernizing Informed Consent 13

disclosure duty even further, limiting the types of procedures for which
informed consent is required,44 or identifying a limited set of risks that need
to be disclosed.45

C. Understanding Materiality in Informed Consent

where medication was negligently administered at a higher dose than indicated, holding
that advising a patient “of the general risk of negligence … is inadequate to the purposes of
the informed consent rule[.]”); Mull v. Emory University, 150 S.E.2d 276, 292 (Ga. 1966)
(holding that the informed consent rule “applies only to the duty to warn of the hazards of a
correct and proper procedure of diagnosis or treatment, and has no relation to the failure to
inform of the hazards of an improper procedure”); Mallett v. Pirkey, 466 P.2d 466, 470
(Colo. 1970) (“A doctor does not have a duty to disclose the risks of the improper
performance of an appropriate procedure.”); Binur v. Jacobo, 135 S.W.3d 646, 655 (Tex.
2004) (holding that “failing to disclose that a diagnosis or prognosis may be or is erroneous
when that diagnosis or prognosis supports a recommendation to undergo a surgical
procedure is not a risk that is “inherent to” and “inseparable from” the surgical procedure
itself”); Felton v. Lovett, 388 S.W.3d 656, at 661-62 (Tex. 2012) (defining the “inherent
risks of treatment” as those “which are directly related to the treatment and occur without
negligence,” excluding information about “eventualities or non-treatment-specific injuries,
such as the possibility of hospital infections, or complications which occur without
particular regard to the treatment the patient receives.”).
44
See, e.g., Morgan v. MacPhail, 704 A.2d 617 (Pa. 1997) (limiting informed consent
liability to “surgical or operative” procedures); Karlsons v. Guerinot, 57 A.D.2d 73
(N.Y.S.2d 1977) (limiting informed consent liability to cases involving “some affirmative
violation of the patient's physical integrity such as surgical procedures, injections or
invasive diagnostic tests”). Courts in states like Pennsylvania and Louisiana have found
that physicians cannot be sued for breach of informed consent when they fail to provide
information in connection with setting a broken bone, administering a flu shot, performing
a blood test, performing a blood transfusion, administering radiation treatment, performing
chiropractic manipulation, administering IV drugs, and treating a patient post-operatively
eye drops. Most states justifiably reject this limitation, however. As explained by the New
Jersey Supreme Court, “The critical consideration is not the invasiveness of the procedure,
but the patient's need for information to make a reasonable decision about the appropriate
course of medical treatment, whether invasive or noninvasive.” Matthies v. Mastromonaco,
733 A.2d 456, 464 (N.J. 1999)
45
For example, Iowa and Louisiana’s informed consent statutes limit required
disclosures to “the known risks, if any, of death, brain damage, quadriplegia, paraplegia,
the loss or loss of function of any organ or limb, of disfiguring scars associated with such
procedure or procedures,” Iowa Code Ann. § 147.137; La. Rev. Stat. Ann. 40:1299.39.5;
(upheld in LaCaze v. Collier, 416 So. 2d 619, 622 (La. Ct. App.) writ granted, 420 So. 2d
440 (La. 1982) and aff'd, 434 So. 2d 1039 (La. 1983)). See also Ga. Code Ann. § 31-9-6.1
(limiting disclosure to the material risks of “infection, allergic reaction, severe loss of
blood, loss or loss of function of any limb or organ, paralysis or partial paralysis,
paraplegia or quadriplegia, disfiguring scar, brain damage, cardiac arrest, or death”).
14 Modernizing Informed Consent

Perhaps because there has been widespread agreement since the


1960’s that the standard risk-and-benefit disclosure satisfies both the
patient-based and physician-based standards of informed consent, there has
been little comprehensive discussion of what materiality to patient decision-
making means in a broader sense. As recognized by many commentators,
legal definitions of “materiality” in the context of informed consent tend to
be somewhat vague.46 The few courts that have attempted to provide a
definition have held that material facts are those that a reasonable patient
would find “significant” in making a medical decision.47 And with the
exception of cases analyzing the therapeutic privilege, no court has
considered the secondary question of whether informed consent requires
disclosure of all facts a patient would consider material, or whether policy
considerations or other factors might limit legally required disclosures to
only some material facts.
It is problematic that the concept of materiality has, to date, been so
under-theorized. While most courts and commentators have historically
agreed that that the physician’s legal duty of disclosure only pertains to
medical facts (under the standard risk-and-benefit disclosure), lay
definitions of materiality – and understandings of materiality from an
ethical perspective – are far broader.

1. Medical Materiality: Common Law Limitations

Legal scholars interpreting the common law history of informed


consent have concluded that, with very rare exceptions,48 the physician’s
duty only extends to disclosure of medically material facts – not other types
of information that may nevertheless be relevant to a patient’s choice.49

46
Waltz & Scheuneman, supra note 34 (noting that informed consent case law “ha[s]
not clearly articulated standards of materiality”); BERG et al, supra note 17, at 64-65
(noting a “lack of clear definition of the scope” of required informed consent disclosure).
According to some commentators, “the law can tolerate a vague definition of materiality”
because of the strict causation requirements for informed consent cases – that is, the
success or failure of an informed consent action depends on whether the plaintiff
demonstrated that a reasonable patient in her position would have made a different decision
had she been properly informed. Margaret A. Berger and Aaron D. Twerski, Uncertainty
and Informed Choice: Unmasking Daubert, 104 MICH. L. REV. 257, 275 (2005). As noted
in Part IV-D, however, these two issues are intertwined.
47
See supra, notes 34-36.
48
Most notably, required disclosures of some financial conflicts of interest (see Part
III-A-2, infra).
49
See generally, Marjorie M. Shultz, From Informed Consent to Patient Choice: A
New Protected Interest, 95 Yale L.J. 219, 284-285 (1985).
Modernizing Informed Consent 15

William McNichols describes cases about the withholding of non-medical


“collateral” information as “at the boundary of the theory” of informed
consent.50 Similarly, Judith Daar (while ultimately arguing for a more
nuanced view of disclosure obligations) describes cases involving
disclosure of non-medical information as reaching “beyond traditional
doctrine requiring disclosure of treatment risks and alternatives.”51 She
describes this “therapeutic limitation” on informed consent disclosure as
effectively “tell[ing] physicians that they need not look beyond the medical
needs of their patients in disclosing information about treatment. The
physician need not be concerned with his patient as an investor, a business
manager, a father, or a spouse.”52 These interpretations are consistent with
the practice of medical professionals and their understanding of their ethical
obligations. The American Medical Association’s ethical guidance on
informed consent, for example, describes the physician’s obligation as
“present[ing] the medical facts … and mak[ing] medical
recommendations,” and does not speak to other facts the physician might
disclose

2. Broader Lay Understandings of Materiality

It is widely understood that a variety of different factors can affect


patient decisionmaking. Medically material facts, such as information about
the medical efficacy of a procedure and its likelihood of improving the
patient’s physiological well-being (“Will this procedure be successful in
easing my symptoms?”), are obviously essential to a patient’s decision.
However, a patient choosing to pursue one avenue of treatment may have a
variety of different reasons for doing so, some of them falling outside the
scope of medical fact. “How much will this procedure cost? How will I feel
about my body after this procedure? Will I be subject to discrimination after
this treatment? Does the hospital look like a luxury hotel? Do I trust my
doctor?” A patient’s choice of whether to undergo a procedure (or where or
by whom to have the procedure) may change depending on the answers to
any of these questions. As noted by Judith Daar, “the realities of human
decision-making will inevitably blur [the] line [between medical and
nonmedical interests].” 53

50
William J. McNichols, Informed Consent Liability in a Material Information
Jurisdiction: What Does the Future Portend, 48 OKLA. L. REV. 711, 713 (1995)
51
Daar, supra note 15, at 188-189.
52
Id. at 195.
53
Daar, supra note 15, at 196. See also BERG et al, supra note 17, at 179 (“[T]o
encourage patients’ reflections on what selection of a course of treatment is likely to mean
16 Modernizing Informed Consent

Moreover, the principles of decisional autonomy that underlie both


the ethical and legal doctrines of informed consent would support a broader
interpretation of materiality. If the goal of autonomous choice in the
medical context is decision-making in accordance with a patient’s personal
goals and values, then non-medical factors are surely material under a lay
definition.54 And the breadth of debate about the possible expansion of
informed consent in the contexts mentioned in Part III provides further
support for the idea that materiality might be interpreted to include non-
medical information.

3. Relevance of Materiality Regardless of Jurisdiction

Understanding what type of information is material to patient


decision-making is important regardless of whether a jurisdiction adopts a
physician-based, patient-based, or mixed standard of care. While only those
jurisdictions adopting a patient-based standard of disclosure explicitly look
to materiality to define the contours of informed consent, patient-centered
language about the “facts … necessary to form the basis of an intelligent
consent by the patient” is prevalent even in physician-based jurisdictions.55
Moreover, the causation requirement for informed consent means that even
physician-centered jurisdictions must look to the relevance of an
undisclosed fact to the patient’s decision-making process when analyzing
informed consent claims.
Modern scholars recognize that the while the distinction between
patient- and provider-based disclosure standards may be helpful as a
theoretical matter, “in practice the boundary between these two standards is
often blurred.”56 Many courts, while purporting to adopt a single standard,
often adopt something closer to a mixed model, incorporating aspects of
physicians’ usual practices while at the same time recognizing the
importance of the patient’s informational needs.57 For example, the
decision of the Kansas Supreme Court in Natanson v. Kline is widely cited
as an example of the physician-based standard; there, the court framed the
liability issue in terms of whether the physician’s disclosures were “in

to their lives, physicians may have to go beyond the narrow requirements of the law.”)
54
See Largey v. Rothman, 540 A.2d 504, 508-509 (N.J. 1988) (arguing that “that the
physician's duty of disclosure ‘arises from phenomena apart from medical custom and
practice’: the patient's right of self-determination,” which defines “the direction in which
[the patient’s] interests seem to lie.”).
55
Natanson v. Kline, 354 P.2d 670, 672-673 (1960)
56
BERG et al, supra note 17, at 51.
57
Id. at 51-52.
Modernizing Informed Consent 17

accordance with those which a reasonable medical practitioner would make


under the same or similar circumstances.”58 However, the court also
emphasized that the physician’s duty includes a duty to disclose “significant
facts within [the physician’s] knowledge which are necessary to form the
basis of an intelligent consent by the patient to the proposed form of
treatment,” a determination which necessarily relies on the patient’s needs
and expectations.59 Other courts are more explicit in recognizing that both
professional standards and patient expectations are relevant to determining
the scope of disclosure. The Wisconsin Supreme Court in Scaria v. St. Paul
Fire & Marine Ins. Co., for example, held that “[t]he disclosures which
would be made by doctors of good standing, under the same or similar
circumstances, are certainly relevant and material and we surmise would be
adequate to fulfill the doctor's duty of disclosure in most instances,” but
emphasized that “the duty to disclose or inform cannot be summarily
limited to a professional standard that may be nonexistent or inadequate to
meet the informational needs of a patient.”60
Moreover, many courts that purport to adopt a physician-based
standard have arguably done so on the basis of a misinterpretation of the
foundational physician-standard cases. The earliest cases that relied on
professional custom to define the duties of disclosure did so in an era when
physicians would regularly shield patients from troubling information (such
as a cancer diagnosis) on the basis of the “therapeutic privilege” – the idea
that sometimes, disclosure of medical facts may do more harm than good
for some patients prone to emotional trauma.61 In Salgo v. Leland Stanford
Jr. Univ. Bd. of Trustees, for example, the disputed jury instruction

58
Natanson v. Kline, 354 P.2d 670, 673 (1960)
59
Id. at 672-673 (emphasis added). See also ZeBarth v. Swedish Hosp. Med. Ctr., 499
P.2d 1, 10 (Wash. 1972) (holding that informed consent requires disclosure of “information
which a reasonably prudent physician or medical specialist of that medical community
should or would know to be essential to enable a patient of ordinary understanding to
intelligently decide whether to incur the risk by accepting the proposed treatment or avoid
that risk by foregoing it”); Salgo v. Leland Stanford Jr. University Board of Trustees, 317
P.2d 170, at 181 (Cal. App.) (defining the informed consent obligation as the duty to
disclose “any facts which are necessary to form the basis of an intelligent consent by the
patient to the proposed treatment,” but recognizing the need for physician discretion in
determining the precise contours of disclosure).
60
Scaria v. St. Paul Fire & Marine Ins. Co., 227 N.W.2d 647, 653 (Wisc. 1975). See
also Winkjer v. Herr, 277 N.W.2d 579, 587-88 (N.D. 1979) (holding that even if a
physician’s “disclosure conforms to accepted medical practice,” expert testimony about
medical practice “does not define the legal duty to inform which exists as a matter of law,”
and which requires the physician to “inform the patient of a significant risk of treatment or
of an alternative treatment.”).
61
See generally, FURROW et al, supra note 17, at 336-337.
18 Modernizing Informed Consent

established a patient-based standard: “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.”62 The court, however, noted that disclosure of all risks
might be dangerous in light of “the patient's mental and emotional
condition,” and that therefore a “certain amount of discretion must be
employed consistent with the full disclosure of facts necessary to an
informed consent.”63 The court ordered that the jury instruction be modified
to reflect that “the physician has such discretion consistent, of course, with
the full disclosure of facts necessary to an informed consent.”64
The fact that a physician maintains discretion to limit the scope of
disclosure in exceptional circumstances by no means establishes a
physician-custom-based standard of care. A better interpretation, and one
recognized in more recent cases, 65 is that while the scope of disclosure
depends on those facts necessary for a patient to make an informed
judgment (from the patient’s perspective), the therapeutic privilege allows
physicians to limit disclosure if in their professional opinion such disclosure
would be detrimental to the patient.
Finally, even in jurisdictions that adopt a physician-based standard,
courts still need to evaluate materiality for the purposes of causation. The
causation standard for an informed consent suit (regardless of jurisdictional
definitions of scope of duty) requires a patient to prove that a reasonable
patient would have opted for a different medical course of action had the
physician satisfied her duty to disclosure. The patient needs to demonstrate
that the undisclosed fact would have been material to the reasonable patient
– that is, that the reasonable patient would have been likely to “attach

62
Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 317 P.2d 170, 181 (Cal. App.
1957).
63
Id.
64
Id.
65
See, e.g., Carr v. Strode, 904 P.2d 489, 500 (Haw. 1995) (adopting the patient-based
standard, but recognizing that expert testimont may be necessary “where privileges are
asserted, as to the existence of any emergency claimed and the nature and seriousness of
any impact upon the patient from risk-disclosure”); Bernard v. Char, 903 P.2d 676, 686-7
(Haw. Ct. App. 1995) aff'd, 79 Haw. 362, 903 P.2d 667 (Haw. 1995) (saying that
proponents of the MD standard do so on the basis that “only a physician is capable of
estimating the potential psychological impact that risk disclosure would have on a
particular patient”; finding that “the application of the physician standard in nondisclosure
cases based on the therapeutic privilege exception and the patient standard in cases where
the duty of disclosure clearly applies is consistent with the underlying foundation upon
which the doctrine of informed consent is premised.”).
Modernizing Informed Consent 19

significance” to the fact to such a degree that it would more likely than not
affected her decision.
Thus, questions about what types of information are relevant to
patient decision-making are important regardless of jurisdictional
differences in determining the standard of care for disclosure.

II. EXPANDING THE BOUNDARIES OF MATERIALITY

The common law informed consent standards established in the


1960’s and 1970’s still define the scope of physician liability. Courts
continue to hold that physicians have a duty to disclose information
“material” to a patient’s medical decision-making – including the patient’s
diagnosis and prognosis, the risks and benefits of the recommended
treatment, and the risks and benefits of any alternative treatments.
Today, however, it is increasingly obvious that what counts as
“material” information for the average patient may not captured by the
common law disclosure duty. A patient choosing whether or not to go
forward with a medical intervention may base her decision on a variety of
non-medical factors, including information about the physician, his disease
status, experience, and conflicts of interest; the cost of treatment; or the
social or legal implications of treatment.
This Part categorizes the types of non-medical information that
patients might reasonably consider relevant to their medical decisions (and
therefore suitable for discussion as part of the informed consent
conversation). Some of these categories have already been thoroughly
explored in the literature, while others are of more recent vintage, proposed
in response to changes in the modern health care climate. Whether offered
by policymakers, patient advocates, or academic commentators, these
expanded understandings of what constitutes material information, if
adopted, would revolutionize the doctrine of informed consent.

A. Provider-Specific Characteristics

Every health care provider is an individual with unique


characteristics; patients choosing between providers recognize this fact. The
average patient might choose a treating physician based on her gender, her
ethnicity, her age, the university from which she graduated, her reputation
20 Modernizing Informed Consent

in the community, or any number of other factors. Likewise, a patient


deciding between multiple treatment options might consider information
about the physician’s degree of skill with these treatments (particularly in
the context of surgery), her success rates, and her motivations for
recommending one treatment over another.
The number of prominent lawsuits filed by patients claiming to have
suffered injury as a result of not having access to provider-specific
information is proof that patients consider such information material to their
health care decisions. But with few exceptions, American courts have not
recognized provider-specific disclosures as integral to the common law of
informed consent. While their justifications vary, most courts ground their
decisions in the principle that because “material information” is limited to
information about the risks of a particular medical procedure, information
about a provider’s personal characteristics does not fall within the scope of
materiality.

1. Physician Experience and Qualifications

One of the few cases requiring disclosure of provider-specific risk


information is Johnson v. Kokemoor, in which a patient who was rendered
quadriplegic after surgery brought an informed consent claim on the
grounds that her physician “failed … to divulge the extent of his experience
in performing this type of operation.”66 The jury found for the patient after
the trial court admitted evidence that Dr. Kokemoor failed to accurately
disclose how often he had performed basilar bifurcation aneurysm surgery,
and that he did not discuss the comparative risks of having such a surgery
performed by a relatively inexperienced surgeon.67 The Wisconsin Supreme
Court upheld the trial court’s decision, holding that “a reasonable person in
the plaintiff’s position would have considered such information material in
making an intelligent and informed decision about the surgery.”68 The court
emphasized that Wisconsin’s informed consent law requires disclosure of

66
Johnson v. Kokemoor, 545 N.W.2d 495, 497 (Wis. 1996). The plaintiff in
Kokemoor testified that she asked Dr. Kokemoor a direct question about his experience, to
which he gave an allegedly misleading response. However, because the plaintiff framed
her claim as one grounded in failure of informed consent rather than negligent
misrepresentation, the Wisconsin court analyzed it by reference to affirmative disclosure
obligations under the law of informed consent. Id. at 504, n. 29.
67
Id. at 497.
68
Id. at 505.
Modernizing Informed Consent 21

“all of the viable [treatment] alternatives,” and framed the issue of physician
experience as relevant to the patient’s evaluation of alternative treatments.69
A handful of courts in other states have also held that information
about a provider’s credentials or experience with a given procedure may
need to be disclosed where those facts suggest there might be an increased
risk of injury.70 While most courts are unwilling to impose an affirmative
duty of disclosure of provider qualifications, some have held that providers
who misrepresent their credentials in response to patient inquiries might
nonetheless be liable under the doctrine of informed consent.71 In Howard
v. University of Medicine and Dentistry of New Jersey, for example, the
New Jersey Supreme Court found that “personal credentials and experience
may not be a required part of an informed consent disclosure under the
current standard of care” because that information doesn’t directly relate to
the procedure itself.72 Nevertheless, it held that where a physician actively
misrepresents his qualifications, and those qualifications in fact
substantially increase the risk of the injury the patient suffered, the patient
may have a claim based on informed consent.73

69
Id. at 498.
70
DeGenarro v. Tandon, 873 A.2d 191, 197 (Conn. App. 2005) (holding that
provider’s lack of experience with the dental equipment used on the patient must be
disclosed if it adds to the risk of the patient’s procedure). See also Goldberg v. Boone, 912
A.2d 698, 717 (MD 2006) (holding that it was an issue for the jury to determine whether
the availability of a more experienced surgeon was material for the purposes of informed
consent); Barriocanal v. Gibbs, 697 A.2d 1169, 1172 (Del.1997) (holding that the trial
court erred in excluding evidence the physician’s failure to inform his patient of his lack of
recent aneurysm surgery, and of the option of having the surgery at a teaching hospital
instead). Cf. Wlosinski v. Cohn, 713 N.W. 2d 16, 20, n. 1 (Ct. App. Mich. 2005) (rejecting
an expanded disclosure duty in a case of prior transplant failures, but limiting its holding to
“statistical data regarding past treatment and other background information that has no
concrete bearing on the actual risks of a given procedure.”).
71
Howard v. University of Medicine and Dentistry of New Jersey, 800 A.2d 73 (N.J.
2002) (discussed below); Willis v. Bender, 596 F.3d 1244, 1260 (10th Cir. 2010)
(predicting that “the Wyoming Supreme Court would allow an informed consent claim
where a physician lies to a patient as to physician-specific information in direct response to
a patient's questions concerning the same in the course of obtaining the patient's consent
and the questions seek concrete verifiable facts, not the doctor's subjective opinion or
judgment as to the quality of his performance or abilities.”). See also Paulos v. Johnson,
597 N.W.2d 316, 320 (Minn.Ct.App. 1999) (stating that the physician's misrepresentation
while obtaining patient's consent to surgery that he was board-certified in response to
patient's question presents “a pure informed consent issue” subject to a two-year statute of
limitations).
72
Howard v. University of Medicine and Dentistry of New Jersey, 800 A.2d 73, 83-84
(N.J. 2002)
73
Id. at 84 (“If defendant's true level of experience had the capacity to enhance
substantially the risk of paralysis from undergoing a corpectomy, a jury could find that a
22 Modernizing Informed Consent

The vast majority of courts, however, reject the notion that informed
consent requires affirmative disclosure of physician experience or
qualifications, on the grounds that only information about the proposed
treatment itself qualifies as material.74 In Whiteside v. Lukson, for example,
a Washington appellate court held that the state’s informed consent statute
requires disclosure only of “treatment-related facts, expressly excluding the
physician’s qualifications.”75 The court justified its refusal to expand the
doctrine by citing the potentially significant burdens of disclosure on
physicians – imposing a broader duty, according to the court, might require
disclosure of “the physician's own health, financial situation, even medical
school grades[.]”76
Finally, some courts have gone even further in maintaining a narrow
view of disclosure duties, holding that even in cases where physicians
actively misrepresent their experience, no informed consent action will lie.
For example, the Pennsylvania Supreme Court in Duttry v. Patterson held
that information about a surgeon’s personal qualifications and experience is
not material for the purposes of informed consent, even if the patient
specifically requested this information and was misled.77 The court justified
its holding on the grounds that the materiality of the information “does not
shift depending on how inquisitive or passive the particular patient is.”78
Duttry also held that while physicians ought not misrepresent their
credentials, this issue is best addressed through a cause of action for fraud
or misrepresentation, not informed consent.79

reasonably prudent patient would not have consented to that procedure had the
misrepresentation been revealed.”).
74
See, e.g., Ditto v. McCurdy, 947 P.2d 952 (Hawaii 1997); Duttry v. Patterson, 771
A.2d 1255 (PA 2001); Wlosinski v. Cohn, 713 N.W. 2d 16 (Ct. App. Mich. 2005); Duffy v.
Flagg, 905 A.2d 15 (Conn. 2006); Kaskie v. Wright, 589 A.2d 213 (PA 1991); Shock v.
United States, 689 F. Supp. 1424 (D. Md. 1988); Zimmerman v. NYC Health and Hospital
Corp, 458 NYS2d 552 (Ny. App. 1983); Johnson v Jacobowitz (NY App 2009); Thomas v.
Wilcaf, 828 P.2d 597 (Wash. App. 1992); Foard v. Jarman, 326 N.C. 24 (1990); Avila v.
Flangas, 1996 WL 63036 (Ct. App. Tx. 1996) (unpublished).
75
Whiteside v. Lukson, 947 P.2d 1263, 1265 (Wash. App. Div. 3 1997).
76
Id. at 1265. Accord Willis v. Bender, 596 F.Rep. 3d 1244, 1256 (2010). See also
Kaskie v. Wright, 589 A.2d 213, 217 (PA 1991) (“Are patients to be informed of every fact
which might conceivably affect performance in the surgical suite?”); Heinemann, supra
note 8, at 1103 (“Such disclosure may be welcome to patient advocates, but Johnson
provides little basis for drawing the line against disclosures that implicate important issues
of physician privacy.”).
77
Duttry v. Patterson, 771 A.2d 1255 (Pa. 2001)
78
Id. at 1259.
79
Id. See also Duffy v. Flagg, 905 A.2d 15, 23 (Conn. 2006) (“Nothing in our ruling
today suggests that a physician who misleads or misinforms his or her patient about the
Modernizing Informed Consent 23

Thus, at least as a matter of common law, the overarching sentiment


seems to be that information about a provider’s experience or credentials is
not material information that needs to be disclosed as part of the informed
consent process. The few courts that have imposed more stringent
disclosure duties have limited them to a duty not to misrepresent credentials
when asked by the patient, or a duty to disclose physician experience only if
it is significantly likely to increase the risk associated with the procedure
the patient is about to undergo.
Despite courts’ reluctance to mandate disclosure of information
relating to provider experience, some legal commentators have argued that
there is no reason to exclude it from the doctrine of informed consent.
Information about the risks of a procedure as performed by a particular
provider, according to these authors, relates directly to the probability of a
procedure’s success as compared to its alternatives; and a procedure’s
probably of success is surely material, even under the most traditional
understandings of informed consent.80

physician's skills, qualifications, or experience may not be liable in damages for


misrepresentation.”). But see Willis v. Bender, 596 F.3d 1244, 1258-59 (10th Cir. 2010)
(“[W]hen the misrepresentation occurs … in the course of a physician obtaining the
patient's consent to a proposed treatment or procedure, we see no reason why Wyoming
would limit the patient's claim to the more generic negligent misrepresentation tort[.]”);
Johnson v. Kokemoor, 545 N.W.2d 495, 504 n. 29 (1996) (noting that an “overlap between
negligent misrepresentation and informed consent … does not preclude the plaintiff from
making allegations and introducing evidence in an informed consent case which might also
have been pled in a negligent misrepresentation case.”).
80
See, e.g., Twerski and Cohen, supra note 8, at 6 (arguing that “’comparative
provider’ cases, although new and revolutionary, are in fact theoretically more sound and
practically easier to resolve than traditional informed consent cases that focus on
comparing the risks of alternative modes of treatment,” because they avoid the problems of
decision causation inherent in traditional informed consent suits); Douglas Sharrott,
Provider-Specific Quality of Care Data: A Proposal for Limited Mandatory Disclosure, 58
Brooklyn L. Rev. 85, 142 (1992) (arguing that traditional informed consent tests “can be
extended to provider-specific risk information if one views the treatment as not just the
procedure itself, but instead as the procedure as performed by a specific provider.”);
Iheukwumere, supra note 8, at 413 (noting that “it defies logic to assert that the experience
of a physician is immaterial to a patient’s informed consent.”); Ashley H. Wiltbank,
Informed Consent and Physician Inexperience: A Prescription for Liability? 42
WILLAMETTE L. REV. 563, 565 (2006) (citing empirical evidence that patients want to
know if they are being treated by a medical student, and arguing “it would follow that most
patient-driven informed consent jurisdictions would include physician’s experience as a
factor in informed consent.”). But see Heinemann, supra note 8 (arguing that “the doctrinal
foundation of the [Kokemoor] decision is ambiguous,” and raising policy arguments
against the expansion of informed consent to include information about physician
experience).
24 Modernizing Informed Consent

2. Physicians’ Financial Conflicts of Interest

The rise of managed care in the 1980’s and 1990’s brought


increased public attention to the financial relationships between health care
providers and payers. Under managed care, physicians are frequently
offered financial incentives – like capitation, bonuses, and withholds – to
provide cost effective care. Patients and policymakers expressed concern
that these financial incentives might lead physicians to limit their use of
diagnostic testing, specialists, and expensive procedures in an effort to
boost their own earnings.81
Legal commentators throughout this era began to consider the idea
that informed consent might be interpreted to encompass disclosures of
physicians’ financial incentives and conflicts of interest.82 If informed
consent law had not yet embraced economic disclosures, they argued, it was
only because “until very recently, economics has not been a serious concern
for most patients.”83 Under the modern system of managed care, however,
many argued that information about financial pressures to direct or limit
care would surely be material to patient decisionmaking. “Although the
concept of ‘materiality’ can be vague,” wrote one commentator, “an
incentive system strong enough to prompt significant alterations in care can
reasonably be considered material.”84 The American Medical Association,
similarly concerned, adopted an ethical opinion requiring physicians to
disclose “any financial incentives that may limit appropriate diagnostic and
therapeutic alternatives that are offered to patients or that may limit
patients’ overall access to care” (but noting that these obligations could be
satisfied if the health plan itself made the disclosure).85
Some courts were amenable to these concerns. In a series of well-
publicized lawsuits against HMOs and physicians, patients alleged that they
were harmed by being denied or dissuaded from costly treatment. In a few
cases, courts recognized the validity of claims that a physician’s failure to
81
Legislators at the time also banned “gag clauses” in payer contracts that prohibited
physicians from discussing managed care payment practices or treatments that would not
be covered under the plan.
82
See, e.g., Morreim, Economic Disclosure and Economic Advocacy, supra note 4;
Haavi Morreim, To Tell the Truth: Disclosing the Incentives and Limits of Managed Care,
3(1) AM. J. MANAGED CARE 35 (1997); Wolf, supra note 4; Mark Hall, Informed Consent
to Rationing Decisions, 71 MILBANK QUARTERLY 645 (1993)
83
Morreim, Economic Disclosure and Economic Advocacy, supra note 4, at 291.
84
Morreim, To Tell the Truth, supra note 82, at 36. See also BERG et al, supra note 17,
at 212 (it would be “fundamentally unfair to deprive patients of information concerning the
financial pressures that may influence their physicians’ treatment decisions.”).
85
AMA CEJA Opinion 8.132: Referral of Patients: Disclosure of Limitations
Modernizing Informed Consent 25

disclose financial incentives constituted a breach of duty, allowing them to


proceed under theories of informed consent or malpractice.86 A Minnesota
appellate court in 1997, for example, stated that a physician’s failure to
disclose a kickback scheme “presents a classic informed consent issue.”87
Finally, no discussion of physician conflict of interest would be
complete without mentioning Moore v. Regents, University of California, in
which the California Supreme Court held that “a physician who is seeking a
patient's consent for a medical procedure must, in order to satisfy his
fiduciary duty and to obtain the patient's informed consent, disclose
personal interests unrelated to the patient's health, whether research or
economic, that may affect his medical judgment.”88 While that case dealt
with financial incentives to develop and sell a patient’s cell line, rather than
economic incentives associated with participation in managed care, the
California court’s recognition of the materiality of information about
“interest[s] extraneous to the patient's health [that have] affected the
physician's judgment” continues to be cited today.89
Information about physicians’ financial conflicts of interest, while
not medically material under the traditional model, has thus been
recognized some courts and commentators as relevant to the informed
consent process.90 This is probably the clearest case of common law legal

86
In most of these cases, the legal issue for resolution was whether a fiduciary duty
claim for non-disclosure would be duplicative of a malpractice/informed consent claim.
Explain Neade more carefully. See, e.g., DAB v. Brown, 570 N.W.2d 168 (Minn. Ct App
1997) (holding that plaintiff’s claim that MD failed to disclose kickbacks was a malpractice
claim, not a fiduciary duty claim); Neade v. Portes, 739 N.E.2d. 496 (Ill. 2000) (rejecting a
fiduciary duty claim for failure to disclose financial incentives on the grounds that it was
duplicative of the medical malpractice claim); Shea v. Esensten, 208 F.3d 712 (8th Cir
2000) (holding that a jury could find MDs liable for negligent misrepresentation for failing
to disclose a financial incentive to avoid referrals, where this failure to disclose prevented
the plaintiff “from making an informed choice of whether to seek what might have been a
life-saving referral at his own expense”).
87
DAB v. Brown, 570 N.W.2d 168, 171 (Minn. Ct App 1997)
88
Moore v. Regents of Univ. of California, 793 P.2d 479, 485 (Cal. 1990)
89
Id. at 484.
90
It is worth noting that while the existence of a financial conflict of interest is not a
medically material risk in itself, it arguably increases the likelihood of medical malpractice.
That is, the reason a patient might want to know if her physician has a financial conflict is
because she worries that this will lead the physician to recommend treatment that is not
medically indicated (as in the case of a physician who receives money from a
pharmaceutical company) or decline to recommend treatment that would be medically
indicated (in the case of MCO incentives to limit costs of care). Were a physician to
deviate from the standard of care, the patient would surely have a claim for medical
malpractice; the existence of the financial motivation would be, in a sense, irrelevant. See,
e.g., Brannan v. Nw. Permanente, P.C., 2006 WL 2794881 (W.D. Wash. 2006) (in a
26 Modernizing Informed Consent

informed consent duties extending beyond the bounds of medical


materiality.

3. Other Physician-Specific Characteristics

Beyond personal experience and financial conflicts of interest, there


is a host of other information that patients might consider material to their
treatment decisions – either in deciding between different treatment
alternatives, or in deciding between different health care providers. This
might include information about the physician’s medical history, sleep
patterns, substance abuse, disciplinary history, malpractice liability,
criminal history, and even religious or political beliefs. However, while
factors such as these are arguably relevant to some patients, courts
considering common law informed consent claims on these grounds have
generally been unreceptive, except occasionally where there is concrete
evidence of increased medical risk associated with the physician
characteristic.
The reason that a physician’s personal characteristics might be
relevant to a patient’s decision-making is because they may suggest a
greater propensity for negligent or otherwise harmful treatment. For
example, a surgeon who is sleep-deprived or suffers from carpal tunnel
syndrome might be less precise in the operating room. The fact that a
physician has been sued for malpractice or subject to professional discipline
numerous times might suggest a propensity for negligent treatment. A
patient operated on by a surgeon with a communicable disease may have a
risk of contracting this disease during surgery. In that sense, these factors
might reasonably be treated as medically material, because they might
affect the physiological outcome of a given treatment by a particular
physician.
Some courts addressing these types of claims have therefore
concluded that a physician has a duty to disclose personal information only
to the extent it currently affects the physician’s performance and actually
increases a risk associated with treatment. Where, for example, a surgeon
has a health condition that does not actually affect her performance in the
operating room, that information would not qualify as material and subject
to disclosure.91 Likewise, numerous courts have held that a physician’s

malpractice claim, denying plaintiff’s motion to compel production of physician’s


employment contract; holding that motive is not an element of a malpractice claim and that
evidence of financial incentives is irrelevant).
91
See Slutzki v. Grabenstetter, 2002 WL 31114657 (Iowa Ct. App. 2002)
Modernizing Informed Consent 27

history of substance abuse does not need to be disclosed,92 expect perhaps


where the physician’s treatment of the patient actually occurs under the
influence of drugs or alcohol or translates into conduct falling below the
standard of care.93 Even the context of HIV disclosure, where early
informed consent claims were sometimes successful, falls within this
categorization of medical risk.94 While early courts that acknowledged a

(unpublished) (finding that surgeon has no duty to disclose that she suffered from a
herniated disc where the condition only caused pain when the physician was using her arms
above shoulder level, and during operations “the operating table was adjusted to the
surgeon’s level of comfort, and when in a position to operate her arms are always down”);
May v. Cusick, 630 N.W.2d 277 (Wisc. App. 2001) (unpublished) (finding no duty to
disclose history of two minor strokes where there was no evidence that physician suffered
residual effects from the strokes that would constitute a material risk). Compare Hawk v.
Chattanooga Orthopaedic Group, 45 S.W.3d 24 (Tenn. Ct. App. 2000) (allowing informed
consent claim under Tennessee statute to proceed where surgeon failed to inform patient
that he had a disabling hand condition that may have impaired his performance).
92
See, e.g., Kaskie v. Wright, 589 A.2d 213 (Pa. 1991) (refusing to expand the
doctrine of informed consent to cases where the plaintiffs were actually informed of the
“particular procedures,” but were not informed of “facts personal to the treating physician,”
like alcoholism); Williams v. Booker, 310 Ga. App. 209 (Ga. App. 2012) (holding that
neither physician nor hospital had a duty to disclose physician’s alcohol abuse); Mau v.
Wisconsin Patients Compensation Fund, 668 N.W.2d 562 (Wisc. App. 2003) (unpublished)
(denying an informed consent claim where a doctor with a history of substance abuse had
not been using drugs in the months before treating the patient, and was not operating under
the influence at the time of the operation); Albany Urology Clinic PC v. Cleveland, 528
S.E.2d. 777 (Ga. 2000) (denying informed consent, fraud, and battery claims grounded in a
physician’s failure to disclose “negative personal life factor [history of cocaine use] that,
although not directly related to the professional relationship, may, depending upon a
patient’s subjectively held beliefs, impact upon the patient’s consent” where there was no
evidence that the physician was under the influence of cocaine at the time of treatment);
Hidding v. Williams, 578 So.2d 1192 (La. App. 1991) (upholding trial court finding that
failure to disclose chronic alcohol use was a breach of the duty to obtain informed consent,
where the trial judge found as a matter of fact that the physician “abused alcohol at the time
of [plaintiff’s] surgery,” and expert testified that performing surgery under the influence of
alcohol would be a breach of the standard of care and that a physician suffering from
alcohol dependence should inform his patient of this fact).
93
Williams v. Booker, 310 Ga. App. 209, 211-212 (Ga. App. 2012) (“The mere fact of
a physician’s drug or alcohol addiction or use at the time of the alleged malpractice does
not create, in and of itself, a separate issue or claim of medical malpractice. Rather, ‘it is
only when that alcoholism translates into conduct falling below the applicable standard of
care that it has any relevance.’”).
94
During the development of the AIDS crisis in the late 1980’s, many patients who
learned that they were treated by HIV-positive physicians brought claims of negligent
infliction of emotional distress. Health care institutions, in turn, struggled with the issue of
whether to require that HIV-positive health care providers should be treating patients, and,
if so, whether they should be required to disclose their health status. Some hospitals
required their physicians to disclose their HIV status; and the physicians challenged these
actions as discriminatory. See Estate of Behringer v. Medical Center at Princeton, 592
28 Modernizing Informed Consent

physician’s duty to disclose her HIV status recognized that the probability
of HIV transmission from doctor to patient is quite low, they grounded their
findings of possible duty in the fact that the consequences of transmission
effectively constitute a death sentence.95 As noted by the Maryland
Supreme Court in Faya v. Almaraz, the existence of a duty is based on both
the probability and seriousness of harm, and “[w]hile it may be unlikely that
an infected doctor will transmit the AIDS virus to a patient during surgery,
the patient will almost surely die if the virus is transmitted.”96
However, most courts hold that no disclosure of a physician’s
personal characteristics is required, even where those characteristics
arguably increase the medical risk to the patient. Courts adopting this view
base it on a narrow vision of medical materiality -- the idea that doctors
only need to disclose risks “inherent in the treatment,” and not risks that are
dependent on who is performing the procedure.97 As recognized by the
Pennsylvania Superior Court in Kaskie v. Wright, expanding informed
consent to include “facts personal to the treating physician … extends the
doctrine into realms well beyond its original boundaries.”98
Some physician-specific characteristics, however, may be of interest
to patients despite their having absolutely no connection with the medical

A.2d. 1251 (N.J. Super. Ct. 1991); Scoles v. Mercy Health Corp., 1994 WL 686623 (ED Pa
1994).
95
Estate of Behringer v. Medical Center at Princeton, 592 A.2d. 1251 (N.J. Super. Ct.
1991) (in a discrimination claim by a physician against a hospital that required him to
disclose his HIV status, holding that the risk of HIV transmission would be a legitimate
concern to reasonable patients, warranting disclosure, because the risk, while low, is not
negligible, and the potential harm is severe); Faya v. Almaraz, 620 A.2d 327 (MD 1993)
(finding a viable informed consent claim by patients of an HIV-positive surgeon because
the risk of transmission, while “extremely low,” was foreseeable, and the consequences of
transmission are dire). However, given the dramatic advances in medical care for HIV-
positive patients in the past decades, and the fact that many HIV-positive patients go on to
lead long and fulfilling lives, it is unclear whether these legal conclusions would still stand
today.
96
Faya v. Almaraz, 620 A.2d at 333.
97
See discussion at supra notes 41-45. See, e.g., Kaskie v. Wright, 589 A.2d 213 (Pa.
1991) (refusing to expand informed consent to require disclosure of physician’s alcoholism
and lack of license to practice, noting that in this case the patient was indeed informed of
the risks of the “particular procedures … irrespective of the surgeon performing them.”);
Curran v. Buser, 711 N.W.2d 562 (Neb. 2006) (finding that the standard of care did not
require disclosure of physician’s disciplinary history); Cipriano v. Ho, 29 Misc. 3d 952
(N.Y. Sup. Ct. 2010) (noting lack of common law to support an informed consent claim
based on failure to disclose prior restriction of physician’s surgical privileges). These cases
adopt similar reasoning to those cases rejecting disclosure of information about physician
experience and qualifications. See supra, Part III-A-1.
98
Kaskie v. Wright, 589 A.2d 213, 217 (Pa. Super. 1991).
Modernizing Informed Consent 29

risks of treatment. Some patients might prefer not to be treated by a


physician who is a Democrat, a woman, or belongs to particular religion.
Others might opt not to seek treatment from a physician with a criminal
history unrelated to her medical practice. Under broad standards of
materiality, a patient who could demonstrate that she would not have
pursued treatment by that person (decision causation) might be able to
recover – but only if she could also prove that the injury she suffered was
caused by the undisclosed fact (injury causation). Injury causation,
however, will be extraordinarily difficult to prove – a point discussed in
greater detail in Part IV-D. In any event, no serious proposals have been
made to expand informed consent to this arena. Moreover, while anecdotal
evidence suggests that some patients care about these types of issues,99
there is no evidence that any disgruntled patient has brought suit on this
basis.

B. Patients’ Non-Medical Interests

A patient’s decision about whether or not to proceed with a


particular treatment may be driven by the treatment’s impact on her non-
medical interests. That is, the precise physiological consequences of a
medical intervention may be less important to the patient than its
satisfaction of her non-medical goals. These can include financial goals
(avoiding medical bankruptcy), legal goals (obtaining favorable medical
testimony in a civil or criminal trial), social goals (being able to
meaningfully participate in a family member’s wedding; maintaining
privacy), and cosmetic goals (being able to wear high heels100). While
courts have almost uniformly rejected the idea that medical providers might
have a common law duty to disclose factors affecting non-medical interests,
a number of legal and medical commentators have recently proposed
expanding consent disclosures in this way. Moreover, legislatures, in the
context of informed consent to abortion, have expanded physicians’
disclosure duties to include information about the non-medical implications
of the procedure.

99
See Benjy Sarlin, Herman Cain: Thank God My Arab Doctor Wasn’t Muslim!
(2011), available at
http://talkingpointsmemo.com/election2012/herman-cain-thank-god-my-arab-doctor-
wasn-t-muslim.
100
See Hartman v. D'Ambrosia, 665 So. 2d 1206 (La. App. 1995) (upholding a trial
court’s judgment for a patient whose goal in having bunion surgery was to have a “normal”
foot and be able to wear high heels, where the physician failed to inform the patient that the
surgery would not achieve this goal).
30 Modernizing Informed Consent

Generally, courts are in agreement that physicians have no common


law duty to inform patients about the non-medical consequences of a
procedure. In Arato v. Avedon, for example, a patient’s family argued that
his physician had breached his duty to obtain informed consent by failing to
disclose “all material facts that might affect” the patient’s “rights and
interests,” including his financial interests in estate planning.101 The
California Supreme Court firmly rejected this argument, citing its own
admonition in Moore that a “physician is not the patient’s financial
advisor.”102 It held that California law does not impose on physicians an
“undefined [duty] to disclose every contingency that might affect the
patient's nonmedical ‘rights and interests.’”103
Other courts have used similar reasoning to reject informed consent
claims based on a physician’s failure to inform a patient of facts affecting
her non-medical interests. In State v. Presidential Woman’s Center, the
Florida Supreme Court rejected the plaintiff’s claim that an abortion
informed consent statute was unconstitutionally vague because it did not
explicitly limit the scope of required disclosure to medical risks.104
“Physicians are not sociologists, economists, theologians, or philosophers,”
the court noted, “and it is implausible to conclude that the Legislature
intended that physicians be required to venture far beyond their professional
specialty and expertise to advise patients of nonmedical matters” such as the
social or economic risks of abortion.105 Similarly, in a case where a
psychiatric evaluation requested by a patient’s attorney resulted in adverse
testimony in a criminal trial, a Texas court rejected a claim grounded in
non-disclosure of the legal risks associated with medical care.106 The court
held that the possibility of adverse testimony based on a psychiatric
diagnosis was a “risk concern[ing] the legal, rather than the medical,
consequences of the diagnosis,” and that the patient’s attorney (rather than
his psychiatrist) was the person best suited to advise the patient of this legal
risk.107

101
Arato v. Avedon, 858 P.2d 598, 608 (Cal. 1993)
102
Id. (citing Moore v. Regents, University of California, 793 P.2d 479, 486, note 10
(Cal. 1990)). While Moore ultimately held that a physician’s fiduciary duty to his patient
includes a duty to disclose his own conflicts of interest, the court noted that the basis of this
obligation is “not because he has a duty to protect his patient's financial interests, but
because certain personal interests may affect professional judgment.” Moore, 793 P.2d at
486, note 10.
103
Id. at 609 (emphasis in original).
104
State v. Presidential Woman’s Center, 937 So.2d 114 (Fla. 2006).
105
Id. at 119-120.
106
Clark v. Grigson, 579 S.W.2d 263 (Tex. Civ. App. 1978)
107
Id. at 265
Modernizing Informed Consent 31

Legal scholars refer to the principle established in these cases as


reflecting a “therapeutic limitation” to informed consent disclosure.108
According to Judith Daar, cases like Arato “tell[] physicians that they need
not look beyond the medical needs of their patients in disclosing
information about treatment. The physician need not be concerned with his
patient as an investor, a business manager, a father, or a spouse.”109 Robert
Gatter, likewise, acknowledges that the common law of informed consent
“generally permits physicians to remain ignorant of a patient’s non-medical
characteristics” (like the desire to “participate in daughter’s wedding rather
than maximize chances of cure”) despite the fact that these non-medical
characteristics are extremely relevant to a patient’s treatment preferences.110
However, many commentators seem troubled by the common law
limitation on the scope of disclosure to medical interests. Judith Daar notes
that “the realities of human decision-making will inevitably blur [the] line
[between medical and nonmedical interests],” and contends that a
requirement that physicians only disclose information relevant to the
patient’s medical interests “defies the nature of communication.”111 Robert
Gatter, while stopping short of advocating for affirmative disclosure duties,
recommends a broader duty of physician inquiry as part of the informed
consent process – physicians, he argues, ought to be obligated to inquire
about the patient’s subjective and non-medical goals of treatment before
providing treatment recommendations.112
This Part will provide an overview of a number of contexts in which
legal and medical scholars, and sometimes even policymakers, have
suggested broadening the scope of informed consent disclosure to reach
patients’ personal interests.

1. Financial Interests: Cost of Treatment

108
The term “therapeutic limitation” was first used by the Supreme Court of Califonia
in Arato v. Avedon, 858 P.2d 598, at 609.
109
Daar, supra note 15, at 195. See also Robert Gatter, Informed Consent Law and the
Forgotten Duty of Physician Inquiry, 31 LOYOLA U. CHICAGO L. J. 557 (2000).
(interpreting Arato as “indirectly” defining the scope of inquiry to patient’s medical
characteristics only); Richard M. Alderman, The Business of Medicine-Health Care
Providers, Physicians, and the Deceptive Trade Practices Act, 26 HOUS. L. REV. 109
(1989) (concluding that the doctrine of informed consent does not extend to “nonmedical
information” like the business or financial aspects of medical care).
110
Gatter, supra note 109, at 567-568.
111
Daar, supra note 15, at 195.
112
Gatter, supra note 109, at 579.
32 Modernizing Informed Consent

The concern that informed consent doctrine is insufficiently


protective of patients’ non-medical interests has drawn attention most
recently in the context of the dramatic shift in the landscape of health care
financing. Consumers have been shocked by recent empirical studies and
news reports publicizing the dramatic variability among the costs of
different treatments (or the cost of the same treatment in different
institutions).113 Consequently, in the past two years, three articles in major
medical journals and journals of medical ethics have argued that physicians
ought to have a legal or ethical duty to protect their patient’s financial
interests by informing them about the cost of treatment.114
Because of the catastrophic impact medical bills can have on a
patient’s financial situation, Kevin Riggs and Peter Ubel argue that
physicians have an ethical duty to initiate conversations about the financial
burdens of care on a patient “in the same way they would discuss the
adverse effects of a treatment.”115 Ubel and others ground this claim, at
least in part, in the link between financial well-being and medical well-
being – arguing, for example, that financial insecurity can cause people to
“cut corners in ways that may affect their health and well-being,” like
spending less on food, clothing, or prescriptions.116 In a prescient article
published almost twenty years ago, Michael Wilkes and David Schriger
noted that “financial well-being is certainly within the boundaries of most
peoples’ concept of health.”117
While it is certainly true that financial security implicates health
outcomes, so do a host of other factors – including housing status, job
stability, food insecurity, discrimination, and the availability of social
support networks. And while progressive medical providers are learning
about the importance of inquiring about these social determinants of health

113
See references at supra note 12.
114
Hall, Financial Side Effects, supra note 13; Riggs and Ubel, supra note 13; Ubel,
Abernethy, and Zafar, supra note 13.
115
Riggs and Ubel, supra note 13, at 849. See also Ubel, Abernethy, and Zafar, supra
note 13, at 1486 (noting that “given the distress created by out-of-pocket costs, it is well
within physicians’ traditional duties to discuss such matters with our patients.”)
116
Ubel, Abernethy, and Zafar, supra note 13, at 1485 (also referring to the discussion
of costs tradeoffs as “mak[ing] clinical sense”).
117
Michael S. Wilkes and David L. Schriger, Caution: The Meter is Running:
Informing Patients About Health Care Costs, 165 WESTERN J. MED. 74, 78 (1996) (noting
that “discussions about the cost of care are an important part of the physician-patient
relationship”).
Modernizing Informed Consent 33

during routine medical visits,118 they may be not be prepared to predict the
impact of a given medical intervention on these social factors.
A more justifiable argument for including disclosure of costs as part
of informed consent is made by Alicia Hall, who grounds her position in
theories of patient autonomy. Since the purpose of informed consent is to
facilitate autonomous decisionmaking about medical treatment, and since
“what counts as a benefit for a patient cannot be determined by the
physician from an objective medical standpoint,” information about
financial risks is essential for patients to make appropriate trade-offs –
particularly in an environment where “health care providers are also health
care vendors, and patients are also consumers, medical providers take on the
additional obligations associated with business owners and managers.”119
Critics of this argument worry that including a discussion of costs as
part of informed consent will transform the doctor-patient relationship into
a mercantile model driven by cost containment, where patients will no
longer trust their physicians to provide the best clinical advice.120 However,
as Hall recognizes, not every medical option is available to patients even
under our current system, and at least disclosure of cost information would
make this more transparent.121
The most significant concern about proposals to incorporate costs
discussions into informed consent is that physicians typically lack accurate
information about the cost of treatment.122 Proponents of cost disclosure
recognize this fact, but argue that the ethical duty to disclose costs requires
physicians to educate themselves about treatment costs under various
insurance policies, and make inquiries about the patients’ financial

118
Medical-legal partnerships like Loyola University Chicago School of Law’s Health
Justice Project (http://luc.edu/law/centers/healthlaw/hjp/index.html) aim to educate health
care providers about these considerations.
119
Hall, Financial Side Effects, supra note 13, at 42, 44.
120
As noted by Joseph Fins, “If some treatment options are out of a patient's “price
range,” … [w]ould providers simply exclude the more expensive options from the
alternatives available to other customers with coverage or better insurance? So much for
the notion of informed consent as the conveyance of risk, benefits, and alternatives. Put an
asterisk on that and revise the construct as “some” alternatives.” Joseph J. Fins, Fee
Disclosure at a Cost, 44(6) HASTINGS CTR. REP. 3 (Nov.-Dec. 2014) (commentary on Hall,
Financial Side Effects, supra note 13).
121
Alicia Hall, The Author Replies, 44(6) HASTINGS CTR. REP. 4 (Nov.-Dec. 2014)
(commentary on Finn, supra note 120).
122
See, e.g. Giridhar Mallya, Craig Evan Pollack, and Daniel Polsky, Are Primary
Care Physicians Ready to Practice in a Consumer-Driven Environment? 14 AM. J.
MANAG. CARE 661, 665 (2008) (noting that PCPs “may not have the requisite knowledge
to help patients … make such decisions.”).
34 Modernizing Informed Consent

circumstances in order to satisfy this duty.123 It would be unjust, many


argue, for vulnerable patients to bear the burden of discovery and inquiry
when providers are likely have greater ease of access to this information.124

2. Social and Ethical Arguments

Not all factors that might impact a patient’s choice of medical


treatment are as concrete as its financial impact. Some controversial
treatments may also have social and ethical implications that some have
argued ought to be considered as part of the informed consent process.
Notable examples include abortion, surrogacy, end-of-life care, and genetic
testing – medical interventions that pro-life advocates, disability advocates,
and others have challenged as potentially demeaning to human dignity.
Accordingly, some commentators have suggested that physicians seeking
informed consent to these types of medical care be required to first inform
the patient of the ethical arguments and social implications surrounding
their choice.
This concern is most prominent in the context of abortion. Some
state legislatures have recently adopted laws requiring physicians to present
women seeking abortions with information that critics say reflects ethical
perspectives on abortion rather than its medical consequences. For example,
a South Dakota law passed in 2005 requires physicians to disclose that
abortion “will terminate the life of a whole, separate, unique, living human
being” with whom a woman enjoys a constitutionally protected
relationship.125 The U.S. District Court for the District of South Dakota
initially enjoined enforcement of this provision, holding that it “requires
abortion doctors to enunciate the State's viewpoint on an unsettled medical,
philosophical, theological, and scientific issue, that is, whether a fetus is a

123
Hall, Financial Side Effects, supra note 13, at 44-45; Riggs and Ubel, supra note
13, at 849; Ubel at al 1486; C. Alexander, M. A. Hall, and J. D. Lantos, Rethinking
Professional Ethics in the Cost-Sharing Era, 6 AM. J. BIOETHICS W17, at W20-21 (2006).
124
Hall, Financial Side Effects, supra note 13, at 45. Essentially, Hall’s argument boils
down to the idea that informed consent obligations should be based on physicians’ special
expertise, and that in the modern American health care system, physicians’ expertise
extends to the non-medical arena of cost. This is a hotly-debated empirical question.
125
S.D.C.L. 34-23A-10.1 (upheld in Planned Parenthood Minn. v. Rounds, 653 F.3d
662 (8th Cir. 2011) opinion vacated in part on reh'g en banc sub nom. Planned Parenthood
Minnesota, N. Dakota, S. Dakota v. Rounds, 662 F.3d 1072 (8th Cir. 2011) and on reh'g en
banc in part sub nom. Planned Parenthood Minnesota, N. Dakota, S. Dakota v. Rounds,
686 F.3d 889 (8th Cir. 2012)). Identical language is included in the abortion informed
consent laws of North Dakota, and Kansas. N.D. Cent. Code Ann. § 14-02.1-02 (West);
Kan. Stat. Ann. § 65-6709(b)(5), 65-6710 (West).
Modernizing Informed Consent 35

human being.”126 The statute was ultimately upheld on appeal by the


Eighth Circuit sitting en banc – but even then, a strongly worded dissent by
four judges argued that the statute was unconstitutional because it required
physicians to “advise their patients on metaphysical matters about which
there is no medical consensus” and which are “unrelated to the intended
medical procedure.”127
As a matter of common law, however, the two states that have
considered the issue both held that the law of informed consent does not
require doctors to tell their pregnant patients that aborting a fetus constitutes
the killing of a “human being.” In Acuna v. Turkish, the Supreme Court of
New Jersey considered a malpractice action by a woman who claimed that
her OB/GYB “breached a duty owed to her by failing to inform her of ‘the
scientific and medical fact that [her six- to eight-week-old embryo] was a
complete, separate, unique and irreplaceable human being”and that an
abortion would result in ‘killing an existing human being.’”128 The court
roundly rejected the plaintiff’s claim, noting that the common law duty of
informed consent only requires disclosure of “material information
concerning the medical risks of a procedure.”129 The court contrasted the
disclosures requested by the plaintiff, noting that there was no medical or
social consensus that these statements were medical facts, “as opposed to
firmly held moral, philosophical, and religious beliefs.”130 In 2011, an
Illinois appellate court reached the same conclusion, holding that health

126
Planned Parenthood Minnesota v. Rounds, 375 F. Supp. 2d 881, 887 (D.S.D. 2005)
vacated and remanded sub nom. Planned Parenthood Minnesota, N. Dakota, S. Dakota v.
Rounds, 530 F.3d 724 (8th Cir. 2008)
127
Planned Parenthood Minnesota, N. Dakota, S. Dakota v. Rounds, 530 F.3d 724, 741
(8th Cir. 2008) (J. Murphy, Wollman, Bye, Melloy dissenting).
However, another South Dakota law aimed at ensuring that women seeking abortions
are exposed to pro-life arguments prior to consenting to the procedure has recently failed.
The 2011 law would have required every woman seeking an abortion, one day prior to the
procedure, to obtain a consultation at a crisis pregnancy center whose “principal mission”
is “to provide education, counseling, and other assistance to help a pregnant mother
maintain her relationship with her unborn child and care for her unborn child.” The law
was preliminarily enjoined on First and Fourteenth Amendment grounds. Planned
Parenthood Minnesota, N. Dakota, S. Dakota v. Daugaard, 799 F. Supp. 2d 1048, 1053
(D.S.D. 2011).
128
Acuna v. Turkish, 930 A.2d 416, 418 (2007). The plaintiff also argued that “every
physician, before performing an abortion, must advise the patient in clear and
understandable language that ‘the family member [the embryo] is already in existence and
that the procedure—indeed the central purpose of the procedure—is intended to kill that
family member.’” Id.
129
Id. at 418.
130
Id.
36 Modernizing Informed Consent

care providers at Planned Parenthood did not breach their common law duty
of informed consent when they informed the pregnant plaintiff that the fetus
she was carrying was not a “human being.”131 According to the court,
nothing in Illinois common law requires providers to disclose “something
other than [their own] scientific, moral, or philosophical viewpoint [on the
issue of when life begins].”132
Prenatal genetic testing is another context where critics have
challenged the standard informed consent regime. Typically used to screen
for disabilities like Down syndrome, prenatal genetic testing offers
prospective parents the opportunity to make informed decisions about
whether to procreate naturally, whether to procreate at all, or whether to
terminate a pregnancy. However, as recognized by Elizabeth Emens and
other scholars, “at some level, the message from the doctors urging
amniocentesis … is that having a disabled child is worse than not having a
child.”133 This message, according to many disability advocates, reflects a
one-sided and inaccurate perspective on disability.134 Instead, Emens
suggests, parents undergoing prenatal genetic testing should be presented
with accurate information about life opportunities for children with
disabilities, as well as other resources that might help correct for internal
biases and misconceptions about disability.135 The hope is that providing
appropriate framing for information about disability would help remove
social stigma about disability and improve societal attitudes towards those
living with disabilities.
Similarly, in an article about growth attenuation for minors with
profound disabilities, a group of physicians, philosophers, and attorneys
(the Seattle Growth Attenuation and Ethics Working Group) recognized the
profound social implications of this controversial treatment.136 The Working
Group ultimately recommended that parents considering growth attenuation
“be made aware of the objections to growth attenuation expressed by
organizations and individual members of disability communities”137 by
being provided with “information summarizing arguments for and against

131
Doe v. Planned Parenthood/Chicago Area, 956 N.E.2d 564 (Ill. App. Ct. 1st Dist.
2011).
132
Id. at 573 (referring to this as “a contention that we find borders on contrivance”).
133
Elizabeth F. Emens, Framing Disability, 2012 U. ILL. L. REV. 1383, 1412-1413
(2012).
134
Id.
135
Id. at 1417.
136
Benjamin S. Wilfond et al, Navigating Growth Attenuation in Children With
Profound Disabilities, 40(6) HASTINGS CTR. REP. 27 (2010).
137
Id. at 37.
Modernizing Informed Consent 37

this controversial intervention.”138 However, one member of the Working


Group criticized this recommendation as a “remarkable intrusion into
private medical decisions,” noting that it would similarly require that
“parents seeking cochlear implants for a deaf child, surgical correction for
club feet or scoliosis, or a do-not-resuscitate order for a terminally ill child
… be reminded that their decisions may be offensive to others and should
be given literature on the reasons for those disagreements.”139
As a legal matter, however, no court or legislature has even
approached the issue of including information recommended by disability
advocates as part of the informed consent process for genetic testing or
growth attenuation.

3. Impact on Third Parties

Closely related to the suggestion that patients be informed of the


ethical implications of their treatment choices is the argument that, when
third parties are affected by a patient’s treatment decision, the patient ought
to be told about those effects.
Again, this argument arises most commonly in the abortion context,
where some state informed consent laws require that physicians perform an
ultrasound, display the image to the patient, and inform her of the age and
size of the fetus, which could arguably be considered a third party for the
purposes of this discussion.140 Even in states without ultrasound laws, state
informed consent brochures frequently include images and descriptions of
fetuses at various stage of development so that a woman considering
abortion understands the consequences of the procedure on the fetus.141
The Supreme Court in Planned Parenthood v. Casey expressly permitted
such disclosures during the informed consent process, noting that “most
women considering an abortion would deem the impact on the fetus
relevant, if not dispositive, to the decision.”142 While recognizing that

138
Id. at 30.
139
Id.
140
This author takes no position on the issue of fetal status. It is worth noting,
however, that in the context of diagnostic and therapeutic prenatal interventions, women
are routinely told about the risks to the fetus of such interventions (such as amniocentesis,
for example).

141
Nadia N. Sawicki, The Abortion Informed Consent Debate: More Light, Less Heat,
21 CORNELL J. L. & PUB. POL’Y, 7 (2011).
142
Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 882 (1992)
38 Modernizing Informed Consent

information about the consequences to the fetus “have no direct relation to


[the woman’s] health,” the Court found no constitutional barrier to state
laws requiring disclosure of such information.143
In Casey, the Court analogized to the context of organ donation,
writing, “We would think it constitutional for the State to require that in
order for there to be informed consent to a kidney transplant operation the
recipient must be supplied with information about risks to the donor as well
as risks to himself or herself.”144 Indeed, it seems clear that a live kidney
donor would want to know about the impact his donation will have on the
recipient. For example, he might not go through the procedure if he were
informed that the chances of rejection were very high, or if the recipient
were likely to die from other causes post-transplant. Likewise, the
prospective recipient of a live kidney donation (particularly by a close
friend or family member) might not consent to the procedure if he had
concerns about the health implications of kidney removal on the donor.
Surrogate pregnancy is another situation where a treatment’s
physiological impact on third parties might be relevant to patient’s decision.
Part of the reason many people feel uncomfortable with surrogates bearing
intentional parents’ children is because surrogate pregnancy imposes
significant physical and emotional risks on the surrogate. It seems
reasonable to conclude that some people who are unable to bear children on
their own reject surrogacy in favor of other options (like adoption) in part
due to concerns about the impact on the surrogate.
While some medical procedures (like abortion, organ donation, and
surrogacy) have a clear physiological impact on third parties, others may
have third-party consequences that are less tangible. The context of genetic
testing provides one such example. Empirical research demonstrates that
many patients who choose to undergo diagnostic genetic testing do so in
large part “to generate information about other family members’ risks, most
frequently their offspring.”145 Based on this evidence, Nina Hallowell has
argued that health care providers obtaining informed consent to genetic
testing “need to give [patients] the opportunity to reflect upon the impact

143
Id. While the Casey decision was one about the constitutional validity of state
abortion restrictions, and not about the common law standard for informed consent, the
language used by the court is instructive.
144
Id. at 882-883.
145
Nina Hallowell, Consent to Genetic Testing: A Family Affair, in OONAGH
CORRIGAN ET AL, THE LIMITS OF CONSENT: A SOCIO-ETHICAL APPROACH TO HUMAN
SUBJECT RESEARCH IN MEDICINE (Oxford, 2009), at 189.
Modernizing Informed Consent 39

that any decision may have upon their relationships with particular
others.”146
Incorporating facts about a treatment’s non-physiological effects on
third parties has also been suggested in the context of limiting healthcare
costs. In an article about the financial impact of medical choices on the
healthcare system as a whole, M. A. Graber and J. F. Tansey note that many
patients are “unaware of the social impact of their medical options,” like the
economic impact of choosing a brand name medication over a generic.147
Thus, they suggest that doctors should initiate “dialogue about social justice
as part of … the informed consent process.”148 For example, they offer the
following proposed consent form for patients requesting high-cost
prescriptions:
I, as the patient, am requesting that my provider prescribe
drug ___________ for me. I understand there are less
expensive medications that are also effective. I understand
that by requesting this more expensive medication I am
increasing healthcare costs to others, increasing the cost of
insurance, using resources that could be used elsewhere in
the healthcare system and may be taking an additional risk to
my health as all of the side effects of new drugs may be not
known. The reason that I am asking for this medication is
________________________. I believe that the benefit to
me outweighs the potential risks and resultant harms to
others.149
Perhaps unsurprisingly, no court or legislature has followed these
suggestions to incorporate social justice discussions into the legal obligation
of informed consent.

4. Privacy Implications

Some commentators have suggested that where medical diagnosis or


treatment poses a risk of violating a patients’ privacy, physicians
affirmatively disclose this fact. While federal laws like HIPAA and
HITECH as well as state privacy laws provide a great deal of protection for
146
Id. at 195 (“Consent procedures need to emphasize these things, not sweep them
under a carpet of information about abstract risks and benefits.”).
147
M. A. Graber and J. F. Tansey, Autonomy, Consent, and Limiting Healthcare Costs,
31 J. MED. ETHICS 424, 425 (2005).
148
Id.
149
Id.
40 Modernizing Informed Consent

patients’ medical information, there are some contexts that these laws do
not cover and that patients might not recognize as potentially risky from a
privacy perspective. Genetic testing and storage of blood and tissue samples
are two such contexts.150
Sheldon Kurtz has argued that in the context of genetic testing,
patient’s privacy interests are so important that the law should require
physicians to disclose of “the consequences of having information about the
person stored in data banks” as part of the informed consent process.151
These include the risk that stored genetic information might be shared with
insurers, employers, or others in ways that might disadvantage patients.152
Likewise, many patients do not recognize that blood and tissue
samples extracted for diagnostic purposes may be stored by health care
facilities for extended periods of time and may even be used for other
purposes to which the patients did not initially consent. Examples of cases
where patients have subsequently learned about and objected to the storage
and/or use of their bodily materials abound – from John Moore’s suit
against the University of California for the commercialization of a cell line
based on his leukemia cells;153 to the development of the extremely
lucrative HeLa cell line without the knowledge or consent of Henrietta
Lacks or her family;154 to the more recent controversy surrounding
Minnesota’s storage of newborn blood spots.155 One could therefore argue

150
Another example can be found in the context of unusual procedures that likely to be
reported in the media. In an article about facial transplants, one author mentions a consent
form for facial transplants includes disclosure of the potential for media intrusions in their
personal lives. AP, Facing Up to Ultimate Transplant, WIRED (2005), available at
http://archive.wired.com/medtech/health/news/2005/09/68907?currentPage=all
151
Sheldon F. Kurtz, The Law of Informed Consent: From ‘Doctor is Right’ to ‘Patient
Has Rights,’ 50 SYRACUSE L. REV. 1243, at 1258 (2000).
152
Id. While the 2008 Genetic Information Nondiscrimination Act protects against
genetic discrimination in employment and health insurance, it offers no such protection for
discrimination in other spheres, such as life, disability, and long-term care insurance. 42
U.S.C.A. § 2000ff et seq.
153
Moore v. Regents, University of California, 793 P.2d 479 (Cal. 1990).
154
REBECCA SKLOOT, THE IMMORTAL LIFE OF HENRIETTA LACKS (Crown, 2010).
155
Challengers to Minnesota’s blood spot law obtained a victory in 2011, when the
Minnesota Supreme Court held that the state’s storage and dissemination of blood samples
violated the state’s genetic privacy law. Bearden v. State, 806 N.W.2d 766 (Minn. 2011).
Over 1 million blood spots were destroyed pursuant to a subsequent settlement. Lorna
Benson, After Settlement, Minn. To Destroy 1.1M Newborn Blood Samples (Jan. 13, 2014),
available at http://www.mprnews.org/story/2014/01/13/health/newborn-genetic-material-
storage-settlement. A 2014 law later authorized the state department of health to store new
blood spots indefinitely starting in August 2014 with parental consent. 2014 Minn. Sess.
Law Serv. Ch. 203 (S.F. 2047) (WEST).
Modernizing Informed Consent 41

that if the privacy risks associated with the extraction of bodily material are
substantial enough that they would cause patients to decline a diagnostic or
therapeutic procedure, those risks ought to be disclosed.156

5. Availability of Support and Resources

A final category of information that might be material to a patients’


medical decisions (but would not fall within the category of medical
materiality) is information about financial and social support resources
available to the patient depending on her health care decision.
In the abortion context, legislatures have taken the lead on
incorporating such information into the informed consent process. Many
states require that patients seeking abortions be provided with information
about adoption agencies, crisis pregnancy centers, state financial assistance,
medical assistance, and social support services available to mothers and
children.157 In 1986, the Supreme Court in Thornburgh v. Am. Coll. of
Obstetricians & Gynecologists rejected as unconstitutional a requirement
that women seeking abortions be advised of the availability of medical
assistance benefits and paternal financial support, noting that the required
information was “nonmedical information beyond the physician's area of
expertise,” “irrelevant and inappropriate” for many patients, and ultimately
“not relevant to [informed] consent.”158 In 1992, however, the Supreme
Court’s decision in Casey rendered such arguments invalid. In Casey, Court

156
But this result can be avoided, because there is often a second opportunity for
conversation and consent after the procedure is complete. That is, it is possible to
disentangle a patient’s consent to diagnostic testing from her subsequent consent to storage
or research use of the samples. Indeed, it may be better to split the consent process in this
way. Disclosing a risk of privacy breach when asking for consent to diagnostic testing may
cause patients to decline testing if they believe the privacy risk is unavoidable. However,
splitting the consent process into two consent conversations – one for the procedure and
one for subsequent use of blood or tissue – makes it clear that the patient can reap the
benefits of diagnostic testing without suffering its attendant privacy risks.
157
Rachel Benson Gold and Elizabeth Nash, State Abortion Counseling Policies and
the Fundamental Principles of Informed Consent, 10(4) GUTTMACHER POL’Y REV. (Fall
2007).
158
Thornburgh v. Am. Coll. of Obstetricians & Gynecologists, 476 U.S. 747, 763-64,
106 S. Ct. 2169, 2180, 90 L. Ed. 2d 779 (1986) overruled by Planned Parenthood of Se.
Pennsylvania v. Casey, 505 U.S. 833, 112 S. Ct. 2791, 120 L. Ed. 2d 674 (1992). See also
Planned Parenthood League of Massachusetts v. Bellotti, 641 F.2d 1006 (1st Cir. 1981)
(noting that while information about the availability of adoption and public benefits does
not “bear[] directly on any medically relevant factor” and so does not “fit[] easily within
the traditional ambit of informed consent,” it may be material to a woman’s decision and
therefore bears a reasonable relation to the state’s interest).
42 Modernizing Informed Consent

found that “information relating to fetal development and the assistance


available” to women who choose to carry their pregnancies to term is
relevant to a woman’s abortion decision, and therefore that a statutory
requirement requiring disclosure of opportunities to review such
information is a “reasonable measure to ensure an informed choice.”159
Another context in which information about social support
resources might reasonably be offered is in the context of prenatal genetic
testing for disability. As noted in Part III-B-2 above, some commentators
have suggested that patients be offered information about disability-related
support resources even before they are tested for genetic anomalies.160
However, such proposals have not been implemented.

IV. ADDRESSING CONCERNS AND PROPOSING LIMITATIONS

From the perspective of medical ethics, the informed consent


process ought to be designed in a way that furthers patients’ autonomy in
the sphere of medical decision-making. Furthering autonomy requires
recognizing the patient’s goals and values, and providing the patient with
the information needed to make a coherent decision in accordance with
these goals and values. And because patients’ treatment preferences are
influenced not only by medical factors, but also by social, financial, and
other factors, an ethically-sound doctrine of informed consent ought, in
theory, to incorporate these types of disclosures as well.
Achieving this ethical ideal is challenging, however. It is for this
reason that neither legal standards nor standards of medical practice
typically require physicians to satisfy this ambitious goal. Even the
staunchest supporters of patient autonomy recognize that pragmatic and
policy considerations may necessitate a narrowing of informed consent
from its broadest possible scope161 – particularly given that expanding the
159
Casey, 505 U.S. at 883. See also Thomas L. Jipping, Informed Consent to
Abortion: A Refinement, 38 CASE W. RES. L. REV. 329, at 384-85 (1987) (noting that the
heart of the informed consent requirement is materiality to a woman’s decision, and
arguing that states should have the freedom to require disclosure of “[n]on-medical
information, or medical information relating to non-medical factors” because such
information may “be highly relevant, even vitally important” to a woman’s decision).
Again, while the Casey decision was decided on constitutional grounds, it effectively set
broader boundaries on what is permissible as part of the informed consent process.
160
Emens, supra note 133, at 1416-17.
161
Jay Katz notes that there are “sharp distinctions between the legal doctrine, as
promulgated by judges, and the idea of informed consent, based on a commitment to
individual self-determination.” KATZ, supra note 1, at xliii. In discussing the court’s
Modernizing Informed Consent 43

scope of informed consent would in turn expose physicians to broader tort


liability risk. It is, however, possible to construct a disclosure obligation
that strikes a fair balance between recognizing patients’ needs and ensuring
that health care providers are not unduly burdened. This section seeks to
achieve that goal.

A. Identifying Material Information for the Individual Patient

One challenge of the idealized informed consent process is that, if


its goal is to further individual patients’ autonomy, a physician must know
what would be material to each individual patient. Legal requirements,
however, dispense with this consideration, turning instead to the standard of
what a “reasonable patient” would find material, rather than any individual
patient’s subjective perspective. Many commentators have criticized the
law’s approach here, arguing that it effectively negates the right of
individual self-determination.162 As noted by Evelyn Tenenbaum in an
article about the objective causation element of informed consent, requiring
patients to prove that the undisclosed information would have caused a
reasonable patient to pursue a different course of treatment is “unfaithful” to
the underlying autonomy-based ideals of informed consent.163
While this criticism may be correct from an ethical perspective,
legal and practical principles (out of necessity) require something more
easily applicable. One concern with allowing breach (and, per Tenenbaum,
causation) to be defined by reference to the needs and expectations of each
individual patient is that patients’ subsequent legal claims would be subject

opinion in Canterbury, for example, he comments that “[t]he strong commitment to self-
determination at the beginning of the opinion gets weaker as the opinion moves from
jurisprudential theory to the realities of hospital and courtroom life.” Id. at 71-72. See also
Schuck, supra note 28 (revisiting the “informed consent gap” between informed consent
idealists and realists).
162
See, e.g., KATZ, supra note 1, at 76-77 (noting that Canterbury’s adoption of a
reasonable patient standard set aside issues of subjective self-determination); FADEN AND
BEAUCHAMP, supra note 1, at 305-306 (noting that standards that may be appropriate for
legal and institutional policies will omit some information relevant to patients; suggesting
that a subjective standard is more in line with the principles underlying informed consent).
163
Evelyn M. Tenenbaum, Revitalizing Informed Consent and Protecting Patient
Autonomy: An Appeal to Abandon Objective Causation, 64 OKLA. L. REV. 697, at 717-19
(2011). See also Scott v. Bradford, 606 P.2d 554, 559 (Okl. 1979) (“To the extent the
plaintiff, given an adequate disclosure, would have declined the proposed treatment, and a
reasonable person in similar circumstances would have consented, a patient's right of self-
determination is irrevocably lost. This basic right to know and decide is the reason for the
full-disclosure rule.”).
44 Modernizing Informed Consent

to self-serving hindsight bias. A second concern is one of judicial economy,


which looks with skepticism on evaluating each informed consent case on
the basis of each individual patient’s needs. Finally, from a practical
perspective, modern medical care today does not allow physicians the years
needed to form extensive relationships with patients that allow them to
tailor disclosure to the patient’s particular needs needs. It seems reasonable
that, if some narrowing of the doctrine of disclosure is necessary, the
objective patient standard may be a good place to start. And indeed, because
most of tort law is based on the expectations and obligations of the
“reasonable person,” narrowing disclosures to information that is material
to the reasonable patient would be entirely consistent with existing tort law
principles.164

B. Limitations of Physicians’ Knowledge and Expertise

A second potential limitation on a broadened understanding of


informed consent is that some of the information that patients might
consider material may be beyond the scope of the physician’s expertise or
knowledge. For example, physicians often do not know how much a
procedure will cost – either as a general matter, or how much it will cost
out-of-pocket to a particular patient after taking into account insurance
coverage. Likewise, discussing the legal or social implications of a
treatment, as discussed in Part III-B-2, is likely outside the average
physician’s scope of expertise, and certainly far beyond what most
physicians learn in medical school.
One of the primary goals of the informed consent obligation is to
correct an information asymmetry between physician and patient, an
asymmetry that is made even starker by the physician’s position of
power.165 It is precisely because physicians are uniquely qualified to
164
Limiting disclosures to those considered material by the reasonable patient,
however, still leaves open the question of whether the “reasonable patient” should be
narrowed to “reasonable female patient,” the “reasonable Jehovah’s Witness patient,” the
“reasonable Hispanic patient.” See generally, Dayna Bowen Matthew, Race, Religion, and
Informed Consent – Lessons from Social Science, 36 J. L. MED. & ETHICS 150, 161-162
(2008) (noting that minority patients may want different types of information disclosed
than white patients).
165
FADEN AND BEAUCHAMP, supra note 1, at 305 (“[T]he reality of informed consent
in clinical medicine and research is that a patient or subject cannot usually achieve
substantial understanding without the aid of the professional(s) seeking consent. [It is the]
“most efficient – and, often, the only – way for the person to achieve an adequate
understanding.”); Franklin G. Miller and Alan Wertheimer, Preface to a Theory of Consent
Transactions: Beyond Valid Consent, in MILLER AND WERTHEIMER, EDS., supra note 20, at
Modernizing Informed Consent 45

provide some types of information relevant to a patient’s decision that we


impose upon them a legal and ethical duty to provide it.166 As noted in
Canterbury, “The average patient has little or no understanding of the
medical arts, and ordinarily has only his physician to whom he can look for
enlightenment with which to reach an intelligent decision. From these
almost axiomatic considerations springs the need, and in turn the
requirement, of a reasonable divulgence by physician to patient to make
such a decision possible.”167 If the doctrine of informed consent is
premised on physician knowledge and expertise, then it seems difficult to
justify the expansion of this doctrine to require a physician to disclose
information she does not have and cannot easily obtain.
Limiting legally required informed consent disclosures to
information that is both material to patients and within the physician’s
unique expertise might result in a set of disclosure requirements quite
different from the ones set by modern common law and legislation. In
many ways, the range of required disclosures may become broader.
Most notably, many of the physician-specific disclosures
highlighted in Part III-A would be captured by a rule requiring disclosure of
matters within the physician’s unique qualifications and knowledge. Only
the physician knows about her financial conflicts of interest, her level of
experience with a procedure, her substance abuse problems, and her
religious affiliation. If a reasonable patient considers this information
material to a medical decision, she simply has no other choice but to rely on
the physician’s voluntary disclosure.168 However, with the exception of

95 (noting that the asymmetry of information exists in medical contexts is such that
patients have no fair opportunity to self-inform at a reasonable cost). But see Schuck, supra
note 28, at 928-931 (comparing patients and consumers; noting that while sometimes there
are greater inequalities between physicians and patients than between sellers and
consumers, the argument from information and power disparity is not as strong as many
believe).
166
This is especially so given that the informed consent obligation is one that is
imposed on the medical provider himself, not the health care institution that employs or
contracts with the provider.
167
Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir. 1972). See also Cobbs v. Grant,
502 P.2d 1, 9 (Cal. 1972) (offering as a rationale for informed consent doctrine the fact that
“patients are generally persons unlearned in the medical sciences and therefore, except in
rare cases, courts may safely assume the knowledge of patient and physician are not in
parity”).
168
Of course, a well-informed patient could affirmatively ask for the information she
deems material. However, putting the burden of request on patients runs the risk of striating
disclosures among patient populations based on their prior experience with the health care
system and their understanding of what kind of question should be asked. See Duttry v.
Patterson, 771 A.2d 1255, 1259 (PA 2001) (noting that materiality of the information
46 Modernizing Informed Consent

some information about physicians’ financial conflicts of interests,169


American law does not require disclosure of physician-specific
characteristics as part of the informed consent process.
Another category of disclosures that might be captured by this view
of informed consent might be information about the (non-physiological)
social implications of a procedure.
For example, a patient with kidney failure who is learning about
long-term dialysis would certainly want to know that it requires a
commitment to be treated in a dialysis center three times a week for three to
four hours per treatment. This information is material, in part, because the
patient needs to understand that her work schedule will likely need to be
adjusted if she chooses to pursue long-term dialysis. That said, this
information might not be required under an interpretation of medical
materiality that is limited to physiological risks and benefits. Rather, it tells
her about the likely implications of the treatment on her lifestyle – essential
information, to be sure, but unrelated to the treatment’s physiological
consequences.
For another example, consider patients whose prognosis or treatment
is likely to result in a physical disability – i.e., amputation, blindness, living
with a colostomy bag. A host of empirical research demonstrates that
people are notoriously bad at predicting what life with a disability would be
like; most people overestimate the amount of discomfort, anxiety, and
lifestyle changes that come with a disability.170 Physicians who treat such
patients, however, often have a better understanding of how people with
disabilities live their lives, and may be uniquely situated to share this kind
of information with patients with inaccurate perspectives on disability. In an
article arguing for “framing changes” in the context of disability, law
professor Elizabeth Emens suggests that parents undergoing prenatal
genetic testing also be presented with accurate information about how a
child’s disability might affect their lives.171 Providing “up-to-date
information on the life opportunities and life expectancy for various
disabilities,”172 for example, “could help dispel misconceptions about living
with these disabilities and help prospective parents contextualize medical

disclosed “does not shift depending on how inquisitive or passive the particular patient
is.”).
169
Moore v. Regents, University of California, 793 P.2d 479 (Cal. 1990).
170
See, e.g., Jodi Halpern and Robert M. Arnold, Affective Forecasting: An
Unrecognized Challenge in Making Serious Health Decisions, 23(10) J. GEN. INT. MED.
1708 (2008).
171
Emens, supra note 133.
172
Id. at 1417.
Modernizing Informed Consent 47

information, which tends to focus exclusively on the particular problems


associated with a disability.”173
That said, some disclosures that have been advocated by
commentators or have been imposed legislatively would fall outside the
scope of informed consent under this interpretation. Most notably,
information about the cost of medical treatment would be excluded, except
in those exceptional circumstances where physicians do have access to cost
information.174 Likewise, while some commentators have suggested that
physicians disclose information about the social, ethical, legal, and privacy
implications of medical treatment, these too would not be required (perhaps
with the exception of information about the consequences of living with a
disability or the impact of a treatment on third parties, when offered by
physicians with experience in these matters). Finally, physicians would not
be obligated to disclose information about social support resources (like
information about the availability of adoption resources, crisis pregnancy
centers, and financial assistance) that some legislatures have adopted in the
abortion context. Essentially, any information beyond what the physician
learned in medical school, in practice, or concerns her personal
characteristics would be excluded under a physician-knowledge-based
standard of informed consent.

C. Policy Limitations

If we accept the physician-expertise based disclosure model, critics


are likely to argue that the expansive nature of this principle, particularly
with respect to physicians’ personal characteristics, renders it too broad. For
example, the average patient might wish to know how much sleep a surgeon
has had before consenting to an operation – but few commentators have
argued that these kinds of facts ought to be required as part of informed
consent. Indeed, while an idealized version of patient autonomy would

173
Id. 1415. As an example of this, Emens cites the 2008 Prenatally and Postnatally
Diagnosed Conditions Awareness Act, which “aims to help provide prospective parents
who receive a positive prenatal (or postnatal) diagnosis of Down syndrome or other
conditions with "up-to-date information on the range of outcomes for individuals living
with the diagnosed condition, including physical, developmental, educational, and
psychosocial outcomes."' However, as Emens notes, the Act would require disclosure after
the point of diagnosis, not before testing. Id. at 1415 (citing Prenatally and Postnatally
Diagnosed Conditions Awareness Act, Pub. L. No. 110-374, 122 Stat. 4051 (2008)).
174
Practice areas where physicians are more likely to know the cost of treatment
include psychiatry and cosmetic surgery.
48 Modernizing Informed Consent

require such disclosures, there are legitimate policy reasons why we might
not want to extend the legal requirement of informed consent that far.175

1. Physician Privacy

Some facts that are uniquely known to the physician may be deemed
to be too personal, or too private, for disclosure.176 These may include the
physician’s disability status, her personal habits, her religious beliefs, and
recent personal trauma. Such information, it could be argued, falls within
the private sphere of a physician’s life, and even patients ought not have
access to it without the physician’s consent. In contrast, information about
experience levels or success rates with a particular procedure may be
understood as more directly related to the physician’s medical practice;
likewise, information about financial conflicts of interest might be deemed
publicly-accessible enough that it ought to be disclosed. Many would argue
that physicians entering medical practice should be entitled to a reasonable
expectation of privacy with respect to their personal affairs – or at the very
least, should not be required to disclose their private information as a matter
of law. Even politicians and other public figures, whose personal lives often
end up in the news, are not required by law to share deeply personal
information, despite its potential relevance to voters.177
That said, the boundaries of what physician-specific information
should be deemed too private for mandatory disclosure are unclear; a more
careful and nuanced analysis of this issue is surely necessary.178 However,

175
In limited cases, there might also be constitutional limitations on extending the
doctrine too broadly. See Bobinski, supra note 11, at 333-337 (discussing First Amendment
limitations); Albany Urology Clinic, P.C. v. Cleveland, 528 S.E.2d 777, 782, FN 19 (Ga.
2000) (discussing vagueness concerns).
176
See Heinemann, supra note 8, at 1003-06 (discussing privacy concerns); Whiteside
v. Lukson, 947 P.2d 1263, 1265 (Wash. App. Div. 3 1997) (expressing concern that
broadening the informed consent duty would require disclosure of “the physician's own
health, financial situation, even medical school grades[.]”)
177
One exception to this relates to disclosures of financial conflicts of interest by
political figures and elected officials.
178
Some might argue that it is not necessary to include information about physician
characteristics within the informed consent disclosure duty. Much physician-specific
information (about their habits, their disability, their financial conflicts) is material to
patients only because of the concern that these physician-specific characteristics will lead
to poor medical outcomes – for example, a physician who is paid as a consultant to a
pharmaceutical company might prescribe that drug rather than a more appropriate one. If
this is the case, critics argue, then it’s not clear why the informed consent cause of action is
even necessary. Patients who are injured by physician error will be able to sue for
malpractice regardless of the reason for the error; the non-disclosure of a characteristic that
Modernizing Informed Consent 49

for the purposes of this Article, it will suffice to recognize that some
limitations ought to be placed on physician-specific disclosure in light of
reasonable concerns about personal privacy.

2. Long-Term Impact on Patient Care

In addition to privacy concerns likely to be expressed by physicians,


there are a host of utilitarian concerns about the long-term implications of
sharing certain types of information, particularly relating to physician
experience. As many commentators have already recognized, requiring
physicians to affirmatively disclose their level of expertise or their success
rates with a given treatment will likely result in shifting patient loads.179
That is, patients with the ability to choose among different providers may
flock to more experienced physicians. Those physicians will have heavy
patient loads, while less experienced providers may find themselves without
enough patients to develop the experience they need to advance in their
fields. Thus, affirmative disclosure of experience levels will make it
difficult for newer providers (or those hoping to learn how to perform new
procedures) to develop their knowledge, and ultimately may result in fewer
experienced physicians overall. A related concern is that the distribution of
patients among providers is likely to be stratified in unjust ways. For
example, patients of low socio-economic status, patients with serious illness
requiring immediate treatment, and those whose insurance limits their
access to providers may find themselves with less access to more-favored
physicians, and might in turn have worse outcomes.
Another concern about requiring disclosure of success rates in
particular is that this may lead providers to select patients in a way that
disfavors the most critical cases.180 A physician who currently takes on

one might reasonably expect to impair physician performance alone should not be enough
to impose liability. However, I would counter that the informed consent cause of action is
indeed important for patients who are unable to succeed on a traditional malpractice claim.
Perhaps the patient suffered an adverse outcome because her physician prescribed a
medication that she had financial ties to, but a jury is unconvinced that this prescription
actually fell outside the standard of care. The patient, while ultimately unsuccessful in her
malpractice claim, may nevertheless have a reason to pursue an informed consent claim,
and this claim may be more successful.
179
See, e.g., Heinemann, supra note 8, at 1003-1106; Bobinski, supra note 11, at 333-
335; William Nelson and Paul B. Hoffman, Commentary, Physician Experience as a
Measure of Competency: Implications for Informed Consent, 5 CAMBRIDGE QUARTERLY
OF HEALTHCARE ETHICS 458, at 460 (1996).
180
See generally, Kristin Madison, The Law and Policy of Health Care Quality
Reporting, 31 CAMPBELL L. REV. 215 (2008) (noting similar risks associated with public
50 Modernizing Informed Consent

specialty patients with significant risk factors, for example, may choose to
limit her practice to “easier” patients if her statistical outcomes in treating a
high-risk population are lower than those of her peers who choose less risky
patients. This, again, raises justice concerns about the impact on patients.
It is not clear to what extent these risks would actually manifest
themselves if informed consent disclosure duties were expanded to include
information about experience and success rates. But any proposal to
expand disclosure obligations should certainly consider these risks, and
ideally monitor the impact of the new disclosures on patient care in the long
term.

3. Patient Understanding

Another common argument for limiting some types of disclosures


(particularly with respect to success rates) is that the average patient may
not qualified to understand and logically make use of this information.181
This concern has been raised in the context of websites and public reporting
mechanisms, like Hospital Compare, that provide empirical data about
quality measures like readmission rates, surgical complications, and
healthcare-associated infections.182 Some critics have argued that the
empirical information provided is simply not useful to patients, in part
because patients don’t understand the information or can’t interpret it in
useful ways. For those who (rightly) view an ethical informed consent
doctrine as requiring not just mere disclosure, but also understanding, this
concern is certainly important.
A significant problem with this line of argument, however, is that it
has been uniformly rejected as a matter of law. Regardless of ethical
obligations, American law emphasizes disclosure and not understanding –
in part because of how difficult it is for adjudicators to evaluate whether a
patient has substantially understood a disclosure, and in part because of the
belief that more information is always valuable to consumers. In Virginia
State Board of Pharmacy v. Virginia Citizens Consumer Council, for

reporting of provider and institutional quality information).


181
Jay Katz notes that “[f]rom doctors’ point of view, since patients cannot be trusted
to comprehend medicine’s esoteric knowledge sufficiently well, [inviting their participation
in medical decisionmaking] does not make sense.” KATZ, supra note 1, at 91. However,
Katz rejects this argument. “All professions possess esoteric knowledge … [but that] does
not necessarily suggest, however, that this knowledge cannot be communicated to, or
understood by, patients.” Id. at 92.
182
See Madison, supra note 180.
Modernizing Informed Consent 51

example, a First Amendment case about a Virginia law that prohibited


pharmacists from advertising drug prices, the Supreme Court held that
keeping the public in ignorance based on the fear that they will make poor
choices is not a valid reason for suppressing speech.183 While state actors’
suppression of speech is clearly different from the establishment of
informed consent requirements, cases like Virginia State Board of
Pharmacy are instructive because they demonstrate that even if a recipient
of information doesn’t respond to it in the thoughtful way envisioned by the
speaker, that information still has value. This principle is also reflected in
the lengthy disclosures required by law for financial transactions, product
sales, and the like. An entire body of American regulatory law has
developed to identify the information that needs to be shared with
consumers before they enter into a transaction, with almost no consideration
for whether the average consumer is likely to understand this information,
let alone read it.184

4. Injury Causation as Mediating Concerns about Excessive Liability

A final point of debate about expanding physicians’ informed


consent disclosure obligation beyond medical materiality is what practical
effect, if any, this will have. Critics may worry that expanding physician’s
disclosure duties to include material non-medical information would
broaden the scope of physician liability too far. These concerns are
unwarranted, however, as the doctrine of injury causation sets a reasonable
limit on liability in such contexts.
As noted above, a patient who demonstrates that her physician
breached a duty to disclose cannot prevail on an informed consent claim
unless she satisfies a two-pronged standard of causation unique in the world
of negligence. Decision causation requires a plaintiff to prove that, had a
reasonable patient been informed of the undisclosed fact, she more likely
than not would have made a different treatment decision. In a sense, the
decision causation requirement is closely tied (if not identical) to the
materiality standard for identifying duty and breach – information is
material and needs to be disclosed if it would be likely to affect a

183
Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425
U.S. 748 (1976). See also 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, at 503
(1996) (“The First Amendment directs us to be especially skeptical of regulations that seek
to keep people in the dark for what the government perceives to be their own good.”).
184
But see, for example, Senator Elizabeth Warren’s push to make credit card and loan
agreements more readable.
52 Modernizing Informed Consent

reasonable patient’s decision. However, even if a plaintiff demonstrates that


the reasonable patient would have undergone a different medical treatment
had she known of the undisclosed fact, she will only be successful in her
claim if she also proves that the undisclosed fact more likely than not
caused the injury. This requirement is commonly referred to as injury
causation. The secondary requirement of injury causation is closely tied to
the doctrine of proximate causation (also known as legal causation), which
allows recovery only if a negligent act’s causal connection to an injury is
close enough to justify liability.
Notably, many of the expanded disclosures described above – cost,
impact on third parties, physician characteristics, etc. – involve risks that do
not manifest themselves as clearly as traditional medical risks. For example,
even if a court were willing to find that a physician has a duty to disclose
her history of professional discipline, it is unclear how this risk would
manifest itself in a compensable injury. Any injury the patient suffers as a
result of treatment would have to be closely tied enough to the physician’s
undisclosed disciplinary history to satisfy injury causation. This
determination would be highly context-specific, and in many cases might be
difficult to prove. If the physician had previously been disciplined for
sexually assaulting patients during invasive procedures, then a patient who
was sexually assaulted during such a procedure might be able to recover
under informed consent (again, assuming a court is willing to accept a
broadened disclosure duty). But if the patient suffered another, more
common, kind of injury – like a physical complication associated the
procedure – her claim would be unsuccessful for want of injury causation.
Likewise, a patient who successfully argued that her physician had a duty to
disclose the cost of a procedure would conceivably be able to recover if she
suffers medical bankruptcy, but wouldn’t be able to recover for any
physical harms caused by the performance of the procedure. Similarly, a
physician who suffers from alcohol abuse may have a duty to disclose this
fact, but the patient will not be able to recover under informed consent
unless a harm actually arose that is causally related to the alcohol abuse.
Thus, because the category of injuries for which patients might be able to
recover under a doctrine of expanded informed consent would likely be
narrow, concerns about excessive liability for physicians are unwarranted.
That said, critics of expanded disclosure duties would be justified in
their opposition if they could show that some of the disclosures proposed in
Part III would never lead to an associated injury. If a physician fails to
disclose that she is a Democrat, for example, what causally-related and
legally-compensable injury could a patient possibly suffer?185 Tort law
185
Certainly, a patient would not suffer any physical harm as a result of being treated
Modernizing Informed Consent 53

defines duty by reference to foreseeable risk and the precautions that need
to be taken to avoid it. If there is no foreseeable risk from failing to disclose
a particular fact, then there can be no duty and no breach. Consequently,
some of the categories of disclosure described above, while arguably
material to some reasonable patients, would be excluded from disclosure on
the grounds that they will never cause a compensable harm.

CONCLUSION

Revitalizing informed consent to require disclosure of information


that falls outside the scope of medical materiality, while better reflecting
modern understandings of how patients actually make medical decisions,
would represent a dramatic shift. Although few practicing physicians would
advocate for the expansion of informed consent liability beyond traditional
models, policymakers, scholars, and patient advocates have signaled that
such an expansion may be necessary. Thus, it is essential to develop an
ethically sound, legally justifiable, and practically feasible doctrine of
informed consent that incorporates some non-medical disclosures that
patients consider relevant to their medical choices.
This Article argues that an ideal model would require physicians to
disclose any information they are uniquely qualified to provide that would
be material to a reasonable patient’s decision about what kind of medical
treatment to pursue. Disclosures based on the physician’s unique knowledge
and expertise would thus include not only information about the
physiological consequences of treatment and non-treatment, but also
information known to the physician personally about her own
characteristics (such as her experience, conflicts of interest, health status,
etc.). Physicians’ specialized knowledge might also include information
about the practical implications of living with a disability; medical
implications for third parties; and, in some areas of practice where this
information is readily known (like psychiatry and plastic surgery), the cost
of treatment.
That said, this broadened body of knowledge subject to disclosure
may need to be limited for pragmatic and policy reasons. For example,
some physician-specific information might be deemed too personal for
disclosure. Disclosure of information about provider’s quality statistics

by a physician with an opposing political perspective. And any claim for emotional distress
on these grounds would fail given the narrowness of the tort doctrine of negligent infliction
of emotional distress.
54 Modernizing Informed Consent

might lead to patient cherry-picking and have a negative impact on the


health care system overall. Discussion of the precise boundaries of these
potential limitations, however, is beyond the scope of this article.
The model of expanded disclosure proposed herein would, notably,
exclude many categories of information that some commentators believe
ought to be disclosed. These include privacy-infringing physician-specific
disclosures; disclosures about the cost of most treatments; information
about the social, ethical, legal, and privacy implications of treatment; and
information about social services and other supportive resources that are
currently required in the abortion context.
If advocates for such disclosures are correct that the information is
material to patients’ medical decision-making, how do we ensure that we
strike the appropriate balance between supporting patient autonomy and not
imposing undue liability on providers?
Consider the cost of treatment, for example. Because most
physicians do not know the price of the treatments they provide – either as a
general matter or as applied to a particular patient’s insurance plan – this
information would fall outside the scope of required disclosures described
above, and would not subject a non-disclosing physician to tort liability.
That said, patients have very legitimate reasons for wanting to know cost
information before making medical decisions, and excluding cost
information from the realm of informed consent disclosure would put
patients at a disadvantage. But if our goal is to get cost information into the
hands of patients so that they can make better-informed treatment decisions,
we must recognize that there are ways of accomplishing this goal without
imposing additional liability burdens on individual physicians. For example,
some states have established institutional disclosure mandates requiring
hospitals to provide transparent information to patients about the costs of
common treatments.186 Alternatively, states could themselves collect cost
information from insurers and share it with consumers via all-payer claims
databases.187 Both of these options would achieve the goal of informing

186
Catalyst for Payment Reform and Health Care Incentives Institute, Report Card on
State Price Transparency Laws (Mar. 2014). In 2013, Congress proposed a health care
price transparency law that would require such state mandates; however, it has not been
passed. Health Care Price Transparency Promotion Act, H.R. 1326. The Patient Protection
and Affordable Care Act takes a similar approach at the federal level, requiring hospitals to
provide the public with access to information about standard charges for certain services.
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, §2718
(2010). See also Medicare Inpatient Prospective Payment System, 42 C.F.R. §405 et seq
(2014).
187
See Catalyst for Payment Reform, supra note 186, at 1-2.
Modernizing Informed Consent 55

patients without subjecting individual physicians to liability for non-


disclosure of information that is outside their knowledge.
As in many other consumer protection contexts, states may have
valid and compelling reasons for requiring service providers (here,
physicians) to disclose various types of information to consumers (here,
consumers of medical care). But these reasons are different in kind than the
reasons behind traditional ethical and legal doctrines of informed consent.
Informed consent is a common law doctrine grounded in the ethical
obligations of medical professionals to correct for the information
imbalance between patients and physicians. In contrast, state-mandated
disclosure requirements may be aimed at achieving goals extrinsic to
medical profession. Disentangling these two sources of disclosure duties is
important for making sure that patients have access to information that may
be material to their treatment decisions, while ensuring that physicians are
not unduly burdened by the threat of civil liability for failure to disclose
information that is not central to the practice of medicine.
The doctrine of informed consent was originally developed as a
means for furthering patients’ decisional autonomy. However, the type of
information that is available to patients and relevant to their informed
decisions in the 21st century is dramatically different than the information
that was available and relevant a half-century ago. Recognizing these
changes at a broader level promises revitalize the doctrine of informed
consent; and expanding tort law’s understanding of materiality is central to
this mission.

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