Sawicki
Sawicki
Sawicki
BOUNDARIES OF MATERIALITY
Nadia N. Sawicki*
INTRODUCTION
*
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
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
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
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
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
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
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
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
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
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
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
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
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.
A. Provider-Specific Characteristics
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
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
(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
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
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
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
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
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
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
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
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
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
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
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
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
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
C. Policy Limitations
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.
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
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
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
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
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
***