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ULYSSES PACT IN OBSTETRICSULYSSES PACT IN OBSTETRICS
HLTH 7660: THE LAW OF PATIENT CARE
February 12, 2015
Naira Roland Matevosyan, MD, PhD, MSJ
Seton Hall Law School. Emory University. CDC
Presenter's status is amended in 2016.
This presentation took place in 2015, when the presenter was
a law student. The presenter now holds a Master of Science
in Jurisprudence (MSJ) degree from Seton Hall School of Law
11
CONTENTSCONTENTS
Advance Directives - 3
Capacity v. Competence - 4 - 5
Privacy v. Confidentiality - 6
Will-Grammar and Extensions - 7
Will Effect & Termination - 8
Ulysses Contract - 9
The Pact in the United States and DC - 8-14
Viability v. Liability - 15
Presumption v. Probability - 16
The Pact in Canada - 17 - 18
The Pact in Britain - 19
Seminal Cases & Discussions - 20-25 22
ADVANCE DIRECTIVESADVANCE DIRECTIVES
The concept of a living will has been discussed since 1960s, but it was
the case of Karen Anne Quinlan [1] that turned it into law in 1976.
Advance Medical Directives are legal documents that allow an
individual to give directions for her future health care. In some states
these are named Living Will or Durable Power of Attorney (DPOA).
Such documents help protect the legally adult (> 18 years) person's
rights and communicate her choices if she becomes physically or
mentally unable to do so.
It is wiser to complete both documents to provide comprehensive
guidance regarding the care being sought. In the United States,
examples of combined documents include Five Wishes and
MyDirectives.
The Department of Pastoral Care is available to assist with the choice
and preparing of an Advance Directive. [2]
(1) In Re Quinlan 355 A.2d 647 (NJ 1976)
(2) Patrick DL (1994). Measuring preferences for health states worse than death.
Medical Decision-Making; 14:9-19
33
THE COMMON RULETHE COMMON RULE
Bioethics is built around the three main principles:
- Autonomy (respect for mentally competent persons to
make their own decisions);
- Justice (fairness in distribution of burdens/benefits);
- Beneficence (do no harm, do not harm).
Fairly different in their expressions, these principles were
set forth in Nuremberg Code (1947), Declaration of Helsinki
(1964), Belmont Report (1979), and the U.S. Common Rule
(1975-2011). [3]
The Common Rule - chapters govern the autonomy of the (A)
adult human subjects (1977), (B) human fetus (1975), (C)
prisoners (1978), (D) children (1983), and (E) consumption
of the rDNA means or products (2011, see ANPRM). [4]
(3) The Common Rule, 45 C.F.R. Chapter 46.116
(4) 21 CFR Parts 50, 312, 812 44
CAPACITY v. COMPETENCECAPACITY v. COMPETENCE
The Autonomy in signing a consent or a directive (will) has three aspects:
(1) capacity, (2) competence, and (3) personhood (individual, or
organization). Both terms, capacity and competence, are used to
describe a group of measurable features necessary for sole decision-
making. In the U.S. commonlaw, capacity stands for the mental or
cognitive state and competence stands for the legal age (usually > 18
years). In the U.K, the usage of these terms is reversed: competence
refers to functional capacity, and capacity is about the legal age. [5]
When it comes to autonomy, capacity is a threshold element: without
ability to make decisions a person is not autonomous. Capacity is also
task-specific: the patient or parturient may be fully capable of making
medical decisions even if she is unable to care for herself. Capacity
waxes and wanes depending on many factors: patient`s medical
condition, state of mind, level of stress, and ability to accommodate to
unfamiliar to her surroundings. Note: any diagnosis of compromised
mindfulness can interfere with competence, but no diagnosis in a
conscious patient invariably identifies incompetence. For example, the
presence of amnesia or dementia does not prove a lack of capacity to
make medical decisions.
(5) van Norman G (2008) Respecting Patient's Autonomy. CSA Bulletin 55
PRIVACY v. CONFIDENTIALITYPRIVACY v. CONFIDENTIALITY
- are two different things.[6]
Privacy refers to the person and her interests in
controlling the access of others to her personal
or medical data.
Confidentiality refers to the information
collected, classified, and locked.
(6) Sieber JE (2009). Privacy and Confidentiality. Online Ethics Center, National
Academy of Engineering
66
WILL GRAMMAR & EXTENSIONSWILL GRAMMAR & EXTENSIONS
Some advanced directives will identify a person (proxy) who would be
responsible for making treatment decisions on the patient's behalf. The
difference between the Living Will and the DPOA (proxy) is that the former
is a written statement that details the type of care the patient does or
doesn`t want if she becomes incapacitated, and the latter is an appointment
of a trusted health agent (called a proxy, or a health care surrogate). It is
better to prepare both versions or their combined version (see p.3). In the
U.S, directives have several extensions:
Directive to Physicians & Family - records the person's wishes regarding end-
of-life care, the specific life sustaining treatments she wants or does not want
when diagnosed with terminal or irreversible condition.
Medical Power of Attorney - appoints a trusted agent to make health care
decisions not only at the end of life, but at any time.
Out-of-Hospital Do Not Resuscitate Order - allows to refuse certain resuscitation
treatments outside the hospital, including at home, daycare facilities,
ambulance, hospital emergency room, and outpatient settings.
Declaration for Mental Health Treatment - enables to communicate to health
care providers the patient's choices for psychiatric treatment in the event she
becomes unable to speak for herself.
Organ/Tissue Donation Card – permits organ/tissue donation. 77
WILL EFFECT & TERMINATIONWILL EFFECT & TERMINATION
The directive takes effect once the doctor determines that the patient lacks in
ability (U.S.) or capacity (U.K.) to make her own health care decisions.
Specifically, the patient:
- can't understand the nature & consequences of health care choices available to
her;
- is unable to communicate (verbally, in writing, or through gestures) her own
wishes for care.
In some states, the proxy has the authority to manage an immediate medical
care. However, making the will effective immediately will not give the proxy
an authority to override what the patient wants in terms of her care.
The written wishes remain effective as long as the patient is alive, unless she
revokes her document through:
- personally nullifying her written statement before two adult witnesses;
-court order invalidating a highly conflictive or technically erroneous will [7]
- court order revoking the ill-faith-proxy's authority;
- divorce – if the spouse was acting as the proxy;
- death (depending on the will, the agent may be permitted to supervise the disposition of
the corpus, or donation of an organ).
(7) Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990) 88
ULYSSES CONTRACTULYSSES CONTRACT
Ulysses pact or Ulysses contract is a freely made decision to bind
oneself in the future. Women recognize that labor represents a
mind-altering event that may affect their ability to make and
communicate decisions and choices. For this reason, birth plans
and other pre-labor directives can represent a form of Ulysses
contract: an attempt to make binding choices before
unpredictable and overwhelming circumstances of labor. [8]
Widely used in Britain, in the 26 United States, however, pregnant
women are not allowed the right of a living will (see pp. 11-14).
Instead, the doctors carry the duty to make decisions about the
labor management in the best interests of the woman and her
fetus.
(8) Burcher P (2013).The Ulysses contract in obstetrics: a woman's choices
before and during labor. Journal of Medical Ethics; 39(1):27-30
99
IN THE UNITED STATESIN THE UNITED STATES
1010
STATE LAW CITATION
Alabama AL
Advance directive for health
care requires two witnesses.
Not valid if pregnant.
§§ 22-8A-1 to 22-8A-13
Arkansas AR
Both living wills and health
care proxies require two
witnesses. Not valid if
pregnant.
§§ 20-17-202 to 20-17-
218
California CA
Advance directive requires two
witnesses. Not valid if
pregnant. A medical DPOA
requires two witnesses OR a
notary.
Probate Code §§ 4700-
4743
Colorado CO
Health care declaration
requires two witnesses. Not
valid if pregnant. A medical
DPOA does NOT require any
witnesses or notary.
§§ 15-18-101 to 15-18-
113
Connecticut CT
Both living will and DPOA
require two witnesses. Not
valid if pregnant.
§§ 19a-570 to 19a-580d
1111
STATE
continued
LAW CITATION
Georgia GA
Advance directive for health
care requires two witnesses.
Not valid if pregnant.
§§ 31-32-1 to 31-32-12
Hawaii HI
Living will or DPOA for health
care require two witnesses OR
a notary. Not valid if pregnant.
§§ 327E-1 to 327E-16
Idaho ID
No witnesses are required for a
living will and DPOA for health
care. Not valid if pregnant.
Optional submission to the
state registry.
§§ 39-4501 to 39-4509
Illinois IL
Health care declaration (living
will) requires two witnesses.
Not valid if pregnant. One
witness is required for the
DPOA for health care.
Ch. 755, §§35/1 to 35/10
Indiana IN
Both living will and life
prolonging procedurel
declaration require two
witnesses. Not valid if
pregnant. Appointment of a
health care representative
requires one witness.
§§16-36-4-1 to 16-36-
4-21
1212
STATE
continued
LAW CITATION
Iowa IA
Two witnesses OR a notary are
required for a living will or
medical DPOA. Not valid if
pregnant.
§§ 144A.3 to 144A.12
Kentucky KY
Advance directive, section one
(1) requires two witnesses.
Section two (2) requires two
witnesses or notary. Not valid if
pregnant.
§§ 311.621 to 311.644
Minnesota MN
A notary or two witnesses are
required for a health care living
will. Not valid if pregnant. Two
witnesses or a notary are
required for medical DPOA.
§§ 145B.01 to 145B.17
Missouri MO
Two witnesses are required for
a living will. Not valid if
pregnant. Medical DPOA
requires a notary or two
witnesses.
§§ 459.015 to 459.055
STATE
continued
LAW CITATION
North
Carolina
NC
Two witnesses are required for
a living will and medical DPOA.
Not valid if pregnant.
§§ 90-320 to 90-322
North Dakota ND
Two witnesses are required for
a living will and medical DPOA.
Not valid if pregnant.
23-06.4-01 to 23-06.4-
14
Ohio OH
Two witnesses are required for
living will or medical DPOA.
Invalid if pregnant unless
pregnancy won't develop to a
live birth.
§§§§2133.01 to 2133.15
Oklahoma OK
Two witnesses are required for
a living will or for the
appointment of a proxy . Not
valid if pregnant.
Title 63, Ch. 60, §§ 3101.1
to 3102A
Pennsylvania PA
Two witnesses are required for
a living will. Not valid if
pregnant. Appointment of a
surrogate decision maker is
part of the declaration.
Title 20, Chapter 54, §§
5441 to 5447
Rhode Island RI
Two witnesses are required for a
living will or medical DPOA. Not
valid if pregnant and if the fetus
could develop for a live birth.
§§ 23-4.11-1 to 23-4.11-151313
1414
STATE
continued
LAW CITATION
South Dakota SD
Two witnesses are required for a
living will. DPOA requires two
witnesses or a notary. Not valid
if pregnant.
§§ 34-12D-1 to 34-12D-
22
Texas TX
Directive to physicians and
DPOA require two
witnesses. Not valid if pregnant.
§§ 166.031 to 166.053
Utah UT
Advance health care directive
requires one witness. Not valid if
pregnant.
§§§§ 75-2a
Washington WA
Health care directive requires
two witnesses, but is not valid if
pregnant. Medical DPOA does
not require, but does
recommend witnesses.
§§ 70.122.010 to
70.122.920
Wisconsin WI
Declaration to physicians and
medical DPOA require two
witnesses. Not valid if pregnant.
Title 20, Chapter 54, §§
5441 to 5447
Wyoming WY
Two witnesses OR a notary are
required for a living will and
DPOA. Not valid if pregnant.
§§ 35-22-201 to 35-22-
416
VIABILITY V. LIABILITYVIABILITY V. LIABILITY
Ulysses for Entire Pregnancy: Seventeen statutes declare that an advance
directive has no effect during the pregnancy (AL, CA, CT, HI, ID, IN, KS,
MO, NH, OH, OK, SC, TX, UT, WA, WI, WY).
Probability or Medical Certainty that the Fetus Will Grow to Live-birth:
Some states have legislation that does not give effect to an advance
directive if it is probable (AS, MT), possible (AR, IL, MN, ) or supported by
medical certainty (KY, ND) that the fetus will develop to live-birth.
Viability of the Fetus: Two states mention the viability criterion as a limit on
the effect of the advance directive. Colorado (CO) requires fetal viability
before voiding an advance care directive (COLO. REV. STAT. ANN. §15-18-104
(Supp. 2004). Georgia (GA) requires that the fetus be non-viable for the
discontinuation of medical treatment (GA. CODE ANN. § 31-32-8 (2001).
Physical Harm or Pain to the Pregnant Woman: In addition to the
medically certain viability requirement, Pennsylvania (PA) and South
Dakota (SD) require the assurance that physical harm or pain to the
woman will be alleviated (PA. CONS. STAT. § 5414 (Supp. 2004); S.D. CODIFIED
LAWS § 34-12D-10 (Michie 1994).
1515
PRESUMPTION v. PROBABILITYPRESUMPTION v. PROBABILITY
Rebuttable Presumption of Continuation of Treatment: In 1998,
Minnesota legislature fundamentally revised and amended the existing
law (MINN. STAT.ANN. § 145C (West 1998 & Supp. 2004) which now vests:
“when a patient lacks decision-making capacity, is pregnant and in reasonable
medical judgment, there is real possibility that if health care to sustain her life
and the life of the fetus is provided the fetus could survive to the point of live
birth, the health care provider shall presume that the patient would have
wanted such health care to be provided, even if the withholding or withdrawal
of such health care would be authorized were she is not pregnant. This
presumption is negated by health care directive provisions, by clear evidence
that the patient’s wishes, while competent, were to the contrary.” [9, 10]
Probability that the Fetus Would Not Be Born Alive: In Ohio, life-
sustaining treatment can be withheld or withdrawn, if “the declarant’s
attending physician and another physician who has examined the declarant
determine - to a reasonable degree of medical certainty and in accordance
with reasonable medical standards - that the fetus would not be born alive"
(OHIO REV. CODE ANN. § 2133.06(B) 2002).
(9) Burcher P (2013).The Ulysses contract in obstetrics: a woman's choices before and during labor.
Journal of Medical Ethics; 39(1):27-30
(10) Sperling B (1009). Do pregnant women have living will? Journal of Healthcare Law and Policy;
8 (2):331 1616
IN CANADAIN CANADA
Canadian laws are neutral towards issues of advance directives in
pregnancy or labor. In contrast to the American legal system, no
special provision relates to the state of pregnancy.
Without any specific regulations for pregnant women, Canadian
law treats the incompetent pregnant woman who issued an
advance directive while competent the same way as it treats
other incompetent patients. That is to say, it respects the
patient’s right to control her care.
Canadian advance directive (general) legislation covers ten
provinces and one territory. Each province uses slightly
different legal language, and each has different laws for making
and relying on these powerful documents. There is no
legislation for the advanced directives in Nunavut (NU).
1717
PROVINCE/
TERRITORY
INSTRUMENT YEAR CITATION
Alberta AB Act 2000 R.S.A., Ch. S-19, §7
British
Columbia
BC Act 1996 R.S.B.C, ch. 405
Manitoba MB
The Health Care Directives
and Consequential
Amendments Act
1992 S.M., ch. 33
New
Brunswick
NB Informed Person Act 1973 R.S.N.B ch. I-8
Newfoundland NL Act 1995 S.NFLD., ch. A-4.1
Nova Scotia NS Medical Consent Act 1989 R.S.N.S., ch. 279,§ 1
Ontario ON Substitute Decisions Act 1992 S.O., ch. 30
Prince Edward
Island
PE
Consent to Treatment and
Health Care Directives Act
2000
R.S.P.E.I., ch. 10,
amended in ch. 5
Quebec QC Civil Code of Quebec 1991 S.Q., ch. 64, § I
Saskatchewan SK
Health Care Directive and
Substitute Health Care
Decision Makers Act
1997 S.S., ch. H-0.001
Yukon YK
Enduring Power of Attorney
Act
2002 R.S.Y.T, ch. 73
1818
IN BRITAININ BRITAIN
Advanced directives are valid under the British Commonlaw and
are made freely, without undue influence. In England and Wales, one may
make an advance directive or appoint a proxy under the Mental Capacity Act
2005. This is only for an advanced refusal of treatment, when the patient
lacks mental capacity. [11] If a pregnant woman temporarily loses
judgmental capacity, an advance directive would be effective only if it
specifically mentions pregnancy. In case of a doubt, some scholars argue
that a directive refusing all of the recommended forms of medical treatment
is unlikely to be regarded, because the courts may assume that “the woman
had not addressed her mind to the circumstances which have arisen.” [12]
The British Law Commission's view is identical. It is a battery under the British
Law to treat a patient against her express consent. Implied consent is not
enough. The Royal College of Obstetricians & Gynecologists (RCOG)
recommends: "if an incompetent pregnant woman, who was fully informed,
refused treatment during pregnancy in advance, her wishes should be
respected even at the expense of the fetus." [13]
(11) Johnston C, Liddle J (2007). The Mental Capacity Act 2005: a new framework for healthcare
decision making. Journal Medical Ethics; 33 (2): 94–97
(12) Nicola S (2000). Maintaining a pregnancy following loss of capacity. Medical Law Reviews; 8:
275 -279
(13) RCOG (1996). Court-authorized obstetric intervention: A consideration of the Law and Ethics;
§§ 3.4.2, 4.2
1919
SEMINAL CASESSEMINAL CASES
BLUEBOOK CITE: University Health Services, Inc v. Piazzi, Civ. Action No. CV
86-CCV-464 (Super. Ct,. Richmond County, Ga. 1986)
FACTS: Donna Piazzi, 52, was five months pregnant when she was found in a
restroom in coma. She was brought to the hospital brain-dead and with a
living fetus. Her wishes were unknown, as there was no living will left.
PROCEDURAL HISTORY: In July 1986, the University Health Services, Inc
petitioned for a declaratory judgment that life support systems should be
maintained for Donna Piazzi in order to preserve life of her unborn fetus. The
court granted the petition to continue life-support procedures on a brain-
dead pregnant Piazzi, contrary to the request of the patient’s husband and
family. The family appealed.
ISSUE: Whether sustaining life support of a pregnant woman in a permanent
vegetative state to safe fetus against the family's wish was constitutional.
HOLDING: According to the Georgia Law, the woman was dead and therefore
had no protective privacy interest. Because the pregnancy clause of Georgia
legislation determines that the living will would be ineffective during
pregnancy, the woman’s wishes regarding the living will are irrelevant.
JURISPRUDENCE: O.C. G. A. § 9-4-5
DISPOSITION: AFFIRMED
REASONING: Donna Piazzi did not leave any directive. Based on the state
pregnancy clause, the woman was dead under the Georgia Law. 2020
DISCUSSION IN RE PIAZZIDISCUSSION IN RE PIAZZI
Medical technology and scientific knowledge enables healthcare
providers maintain a brain-dead pregnant woman on life-
support for a successful delivery of her fetus. However, the
legality of such practice as well as its ethical implications remain
ambiguous.
The permissibility of such an action is analyzed through discussion
of other legal situations dealing with similar aspects, namely
Abortion Law & Human Tissue Gift Law. These issues include the
moral and legal status of living (viable, non viable) fetus; dead
fetus; interest to life; pragmatical obstacles derived from the
proposed procedure; the legal requirement of consent;
physician-patient relationship, and the status of next-of-kin in
such situation.
The Piazzi ruling has led commentators to assume that the court’s
reliance upon the living will statute indicates that it might reject
the claim that the pregnancy clause is unconstitutional. Piazzi
ruling was notable for what it didn't say. The court did not reflect
on the constitutionality of the pregnancy clause.
2121
CASE 2CASE 2
BLUEBOOK CITE: DiNino v. State 102 Wn.2d 327 (1984)
BACKGROUND: In 1979, the WA Legislature enacted a Natural Death Act
(NDA) according to which adult individuals have a fundamental right to
make decisions concerning medical care, including the decision to forgo
life-sustaining treatment. The NDA created a procedure whereby
individuals could execute a directive which provides for the withholding
or withdrawal of life-sustaining procedures in terminal conditions.
The Act defines that the "directive" may include the following specifics:
- “If I have been diagnosed as pregnant and that diagnosis is known to my
physician, this directive shall have no force or effect during the course of my
pregnancy."
In her living will, plaintiff J.L. DiNino directed that her will was the final
expression of her “legal right to consent to termination of any pregnancy,”
and that contrary to the Washington Natural Death Act it would “have full
force and effect during the course of her pregnancy.”
2222
- continued -- continued -
PROCEDURAL HISTORY: Ms. DiNino and her physician brought a suit against the
state under the Uniform Declaratory Judgments Act, RCW 7.24.020, seeking a
declaration that DiNino's directive was valid and enforceable and that no
physician would be civilly or criminally liable for following it. In the
alternative, they sought a declaration that the Act NDA-RCW 70.122.030(1)(c)
was unconstitutional and void. DiNino argued that her constitutional right to
privacy was infringed under the Act in two respects:
(1) the provision directly inhibited her right to choose to have an abortion, and
(2) it directly infringed upon her right to choose to forego medical treatment.
The state argued that the directive was invalid as written and that the subsection
was constitutional. Both parties moved for summary judgment. The Superior
Court of King County (WA) granted DiNino partial summary judgment,
declaring the pregnancy provision of the Natural Death Act unconstitutional
because "the subsection inhibited a woman’s right to exercise control over her
reproductive decisions; therefore, the provision violated DiNino’s fundamental
right of privacy."
The Superior Court, however, denied the declaration of validity of a woman’s
directive because it attempted to exercise full control over DiNino’s
reproductive decisions beyond the point where the state has a legitimate
interest in such decisions. Both DiNino and the state appealed to the Supreme
Court of WA. 2323
- continued -- continued -
ISSUES: (1) Whether the pregnancy provision in the NDA, RCW 70.122.030(1)
(c) was unconstitutional; (2) Whether DiNino's advanced directive was valid
and enforceable and that no physician would be civilly or criminally liable
for following it under the Uniform Declaratory Judgments Act.
JURISPRUDENCE: Uniform Declaratory Judgments Act, RCW 7.24.020.
DISPOSITION: The Court of Appeals REVERSED the Trial Court decision on
both issues.
REASONING: The Court of Appeals ruled that this case presented a
hypothetical, speculative controversy, and did not present "a justiciable
controversy." The record did not show that women are prevented from
executing directives, that physicians refuse to comply with directives that
are not modeled after the statutory directive, or that the NDA, in the
abstract, directly prevents a woman from obtaining an abortion or choosing
to forgo medical treatments.
Without a factual controversy the Justice believed that an advisory opinion
would not be beneficial to the public or to other branches of government.
OUTCOME: DiNino and her fetus died two days after the forced medical
treatment.
2424
DISCUSSION IN RE DiNINODISCUSSION IN RE DiNINO
Question (1): Why the woman did not benefit from the court's decision?
Answer (1): DiNino could not benefit from the court’s decision because
she (and her fetus) died two days after the forced medical treatment.
Question (2): Did the court avoid the woman's basic right by:
- Imposing undue burdens on the right to terminate pregnancy and make
medical decisions under the 1st, 4th, 9th, and 14th Amendments?
- Depriving women of liberty (bodily integrity) without due process – thus
violating the 14th Amendment?
- Requiring an expression of adherence to the state’s policy protecting fetal
life?
Answer (2): The court stated that Ms. DiNino or her physician had to
make a better effort to look for another physician who would be
willing to place the directive in her file. The real controversy was
between DiNino and her physician.
Question (3): Did DiNino’s physician have a duty to look for another
physician? Will the latter be immune from any possible liability?
Answer (3): This complexity suggests that the laws ruling advanced
directives in obstetrics must have provisions as to the third party
(non-proxy) liability issues. 2525
DISCLAIMERDISCLAIMER
This presentation does not constitute a
legal advice. The burden for determining its
completeness, suitability or appropriateness for
intended use or purpose rests solely on the reader
accessing this information.
The author declares no commercial, strategic, or
financial interest or trusteeship with the names of
entities either used or omitted.
2626

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Ulysses Pact in Obstetrics (by Naira Matevosyan)

  • 1. ULYSSES PACT IN OBSTETRICSULYSSES PACT IN OBSTETRICS HLTH 7660: THE LAW OF PATIENT CARE February 12, 2015 Naira Roland Matevosyan, MD, PhD, MSJ Seton Hall Law School. Emory University. CDC Presenter's status is amended in 2016. This presentation took place in 2015, when the presenter was a law student. The presenter now holds a Master of Science in Jurisprudence (MSJ) degree from Seton Hall School of Law 11
  • 2. CONTENTSCONTENTS Advance Directives - 3 Capacity v. Competence - 4 - 5 Privacy v. Confidentiality - 6 Will-Grammar and Extensions - 7 Will Effect & Termination - 8 Ulysses Contract - 9 The Pact in the United States and DC - 8-14 Viability v. Liability - 15 Presumption v. Probability - 16 The Pact in Canada - 17 - 18 The Pact in Britain - 19 Seminal Cases & Discussions - 20-25 22
  • 3. ADVANCE DIRECTIVESADVANCE DIRECTIVES The concept of a living will has been discussed since 1960s, but it was the case of Karen Anne Quinlan [1] that turned it into law in 1976. Advance Medical Directives are legal documents that allow an individual to give directions for her future health care. In some states these are named Living Will or Durable Power of Attorney (DPOA). Such documents help protect the legally adult (> 18 years) person's rights and communicate her choices if she becomes physically or mentally unable to do so. It is wiser to complete both documents to provide comprehensive guidance regarding the care being sought. In the United States, examples of combined documents include Five Wishes and MyDirectives. The Department of Pastoral Care is available to assist with the choice and preparing of an Advance Directive. [2] (1) In Re Quinlan 355 A.2d 647 (NJ 1976) (2) Patrick DL (1994). Measuring preferences for health states worse than death. Medical Decision-Making; 14:9-19 33
  • 4. THE COMMON RULETHE COMMON RULE Bioethics is built around the three main principles: - Autonomy (respect for mentally competent persons to make their own decisions); - Justice (fairness in distribution of burdens/benefits); - Beneficence (do no harm, do not harm). Fairly different in their expressions, these principles were set forth in Nuremberg Code (1947), Declaration of Helsinki (1964), Belmont Report (1979), and the U.S. Common Rule (1975-2011). [3] The Common Rule - chapters govern the autonomy of the (A) adult human subjects (1977), (B) human fetus (1975), (C) prisoners (1978), (D) children (1983), and (E) consumption of the rDNA means or products (2011, see ANPRM). [4] (3) The Common Rule, 45 C.F.R. Chapter 46.116 (4) 21 CFR Parts 50, 312, 812 44
  • 5. CAPACITY v. COMPETENCECAPACITY v. COMPETENCE The Autonomy in signing a consent or a directive (will) has three aspects: (1) capacity, (2) competence, and (3) personhood (individual, or organization). Both terms, capacity and competence, are used to describe a group of measurable features necessary for sole decision- making. In the U.S. commonlaw, capacity stands for the mental or cognitive state and competence stands for the legal age (usually > 18 years). In the U.K, the usage of these terms is reversed: competence refers to functional capacity, and capacity is about the legal age. [5] When it comes to autonomy, capacity is a threshold element: without ability to make decisions a person is not autonomous. Capacity is also task-specific: the patient or parturient may be fully capable of making medical decisions even if she is unable to care for herself. Capacity waxes and wanes depending on many factors: patient`s medical condition, state of mind, level of stress, and ability to accommodate to unfamiliar to her surroundings. Note: any diagnosis of compromised mindfulness can interfere with competence, but no diagnosis in a conscious patient invariably identifies incompetence. For example, the presence of amnesia or dementia does not prove a lack of capacity to make medical decisions. (5) van Norman G (2008) Respecting Patient's Autonomy. CSA Bulletin 55
  • 6. PRIVACY v. CONFIDENTIALITYPRIVACY v. CONFIDENTIALITY - are two different things.[6] Privacy refers to the person and her interests in controlling the access of others to her personal or medical data. Confidentiality refers to the information collected, classified, and locked. (6) Sieber JE (2009). Privacy and Confidentiality. Online Ethics Center, National Academy of Engineering 66
  • 7. WILL GRAMMAR & EXTENSIONSWILL GRAMMAR & EXTENSIONS Some advanced directives will identify a person (proxy) who would be responsible for making treatment decisions on the patient's behalf. The difference between the Living Will and the DPOA (proxy) is that the former is a written statement that details the type of care the patient does or doesn`t want if she becomes incapacitated, and the latter is an appointment of a trusted health agent (called a proxy, or a health care surrogate). It is better to prepare both versions or their combined version (see p.3). In the U.S, directives have several extensions: Directive to Physicians & Family - records the person's wishes regarding end- of-life care, the specific life sustaining treatments she wants or does not want when diagnosed with terminal or irreversible condition. Medical Power of Attorney - appoints a trusted agent to make health care decisions not only at the end of life, but at any time. Out-of-Hospital Do Not Resuscitate Order - allows to refuse certain resuscitation treatments outside the hospital, including at home, daycare facilities, ambulance, hospital emergency room, and outpatient settings. Declaration for Mental Health Treatment - enables to communicate to health care providers the patient's choices for psychiatric treatment in the event she becomes unable to speak for herself. Organ/Tissue Donation Card – permits organ/tissue donation. 77
  • 8. WILL EFFECT & TERMINATIONWILL EFFECT & TERMINATION The directive takes effect once the doctor determines that the patient lacks in ability (U.S.) or capacity (U.K.) to make her own health care decisions. Specifically, the patient: - can't understand the nature & consequences of health care choices available to her; - is unable to communicate (verbally, in writing, or through gestures) her own wishes for care. In some states, the proxy has the authority to manage an immediate medical care. However, making the will effective immediately will not give the proxy an authority to override what the patient wants in terms of her care. The written wishes remain effective as long as the patient is alive, unless she revokes her document through: - personally nullifying her written statement before two adult witnesses; -court order invalidating a highly conflictive or technically erroneous will [7] - court order revoking the ill-faith-proxy's authority; - divorce – if the spouse was acting as the proxy; - death (depending on the will, the agent may be permitted to supervise the disposition of the corpus, or donation of an organ). (7) Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990) 88
  • 9. ULYSSES CONTRACTULYSSES CONTRACT Ulysses pact or Ulysses contract is a freely made decision to bind oneself in the future. Women recognize that labor represents a mind-altering event that may affect their ability to make and communicate decisions and choices. For this reason, birth plans and other pre-labor directives can represent a form of Ulysses contract: an attempt to make binding choices before unpredictable and overwhelming circumstances of labor. [8] Widely used in Britain, in the 26 United States, however, pregnant women are not allowed the right of a living will (see pp. 11-14). Instead, the doctors carry the duty to make decisions about the labor management in the best interests of the woman and her fetus. (8) Burcher P (2013).The Ulysses contract in obstetrics: a woman's choices before and during labor. Journal of Medical Ethics; 39(1):27-30 99
  • 10. IN THE UNITED STATESIN THE UNITED STATES 1010 STATE LAW CITATION Alabama AL Advance directive for health care requires two witnesses. Not valid if pregnant. §§ 22-8A-1 to 22-8A-13 Arkansas AR Both living wills and health care proxies require two witnesses. Not valid if pregnant. §§ 20-17-202 to 20-17- 218 California CA Advance directive requires two witnesses. Not valid if pregnant. A medical DPOA requires two witnesses OR a notary. Probate Code §§ 4700- 4743 Colorado CO Health care declaration requires two witnesses. Not valid if pregnant. A medical DPOA does NOT require any witnesses or notary. §§ 15-18-101 to 15-18- 113 Connecticut CT Both living will and DPOA require two witnesses. Not valid if pregnant. §§ 19a-570 to 19a-580d
  • 11. 1111 STATE continued LAW CITATION Georgia GA Advance directive for health care requires two witnesses. Not valid if pregnant. §§ 31-32-1 to 31-32-12 Hawaii HI Living will or DPOA for health care require two witnesses OR a notary. Not valid if pregnant. §§ 327E-1 to 327E-16 Idaho ID No witnesses are required for a living will and DPOA for health care. Not valid if pregnant. Optional submission to the state registry. §§ 39-4501 to 39-4509 Illinois IL Health care declaration (living will) requires two witnesses. Not valid if pregnant. One witness is required for the DPOA for health care. Ch. 755, §§35/1 to 35/10 Indiana IN Both living will and life prolonging procedurel declaration require two witnesses. Not valid if pregnant. Appointment of a health care representative requires one witness. §§16-36-4-1 to 16-36- 4-21
  • 12. 1212 STATE continued LAW CITATION Iowa IA Two witnesses OR a notary are required for a living will or medical DPOA. Not valid if pregnant. §§ 144A.3 to 144A.12 Kentucky KY Advance directive, section one (1) requires two witnesses. Section two (2) requires two witnesses or notary. Not valid if pregnant. §§ 311.621 to 311.644 Minnesota MN A notary or two witnesses are required for a health care living will. Not valid if pregnant. Two witnesses or a notary are required for medical DPOA. §§ 145B.01 to 145B.17 Missouri MO Two witnesses are required for a living will. Not valid if pregnant. Medical DPOA requires a notary or two witnesses. §§ 459.015 to 459.055
  • 13. STATE continued LAW CITATION North Carolina NC Two witnesses are required for a living will and medical DPOA. Not valid if pregnant. §§ 90-320 to 90-322 North Dakota ND Two witnesses are required for a living will and medical DPOA. Not valid if pregnant. 23-06.4-01 to 23-06.4- 14 Ohio OH Two witnesses are required for living will or medical DPOA. Invalid if pregnant unless pregnancy won't develop to a live birth. §§§§2133.01 to 2133.15 Oklahoma OK Two witnesses are required for a living will or for the appointment of a proxy . Not valid if pregnant. Title 63, Ch. 60, §§ 3101.1 to 3102A Pennsylvania PA Two witnesses are required for a living will. Not valid if pregnant. Appointment of a surrogate decision maker is part of the declaration. Title 20, Chapter 54, §§ 5441 to 5447 Rhode Island RI Two witnesses are required for a living will or medical DPOA. Not valid if pregnant and if the fetus could develop for a live birth. §§ 23-4.11-1 to 23-4.11-151313
  • 14. 1414 STATE continued LAW CITATION South Dakota SD Two witnesses are required for a living will. DPOA requires two witnesses or a notary. Not valid if pregnant. §§ 34-12D-1 to 34-12D- 22 Texas TX Directive to physicians and DPOA require two witnesses. Not valid if pregnant. §§ 166.031 to 166.053 Utah UT Advance health care directive requires one witness. Not valid if pregnant. §§§§ 75-2a Washington WA Health care directive requires two witnesses, but is not valid if pregnant. Medical DPOA does not require, but does recommend witnesses. §§ 70.122.010 to 70.122.920 Wisconsin WI Declaration to physicians and medical DPOA require two witnesses. Not valid if pregnant. Title 20, Chapter 54, §§ 5441 to 5447 Wyoming WY Two witnesses OR a notary are required for a living will and DPOA. Not valid if pregnant. §§ 35-22-201 to 35-22- 416
  • 15. VIABILITY V. LIABILITYVIABILITY V. LIABILITY Ulysses for Entire Pregnancy: Seventeen statutes declare that an advance directive has no effect during the pregnancy (AL, CA, CT, HI, ID, IN, KS, MO, NH, OH, OK, SC, TX, UT, WA, WI, WY). Probability or Medical Certainty that the Fetus Will Grow to Live-birth: Some states have legislation that does not give effect to an advance directive if it is probable (AS, MT), possible (AR, IL, MN, ) or supported by medical certainty (KY, ND) that the fetus will develop to live-birth. Viability of the Fetus: Two states mention the viability criterion as a limit on the effect of the advance directive. Colorado (CO) requires fetal viability before voiding an advance care directive (COLO. REV. STAT. ANN. §15-18-104 (Supp. 2004). Georgia (GA) requires that the fetus be non-viable for the discontinuation of medical treatment (GA. CODE ANN. § 31-32-8 (2001). Physical Harm or Pain to the Pregnant Woman: In addition to the medically certain viability requirement, Pennsylvania (PA) and South Dakota (SD) require the assurance that physical harm or pain to the woman will be alleviated (PA. CONS. STAT. § 5414 (Supp. 2004); S.D. CODIFIED LAWS § 34-12D-10 (Michie 1994). 1515
  • 16. PRESUMPTION v. PROBABILITYPRESUMPTION v. PROBABILITY Rebuttable Presumption of Continuation of Treatment: In 1998, Minnesota legislature fundamentally revised and amended the existing law (MINN. STAT.ANN. § 145C (West 1998 & Supp. 2004) which now vests: “when a patient lacks decision-making capacity, is pregnant and in reasonable medical judgment, there is real possibility that if health care to sustain her life and the life of the fetus is provided the fetus could survive to the point of live birth, the health care provider shall presume that the patient would have wanted such health care to be provided, even if the withholding or withdrawal of such health care would be authorized were she is not pregnant. This presumption is negated by health care directive provisions, by clear evidence that the patient’s wishes, while competent, were to the contrary.” [9, 10] Probability that the Fetus Would Not Be Born Alive: In Ohio, life- sustaining treatment can be withheld or withdrawn, if “the declarant’s attending physician and another physician who has examined the declarant determine - to a reasonable degree of medical certainty and in accordance with reasonable medical standards - that the fetus would not be born alive" (OHIO REV. CODE ANN. § 2133.06(B) 2002). (9) Burcher P (2013).The Ulysses contract in obstetrics: a woman's choices before and during labor. Journal of Medical Ethics; 39(1):27-30 (10) Sperling B (1009). Do pregnant women have living will? Journal of Healthcare Law and Policy; 8 (2):331 1616
  • 17. IN CANADAIN CANADA Canadian laws are neutral towards issues of advance directives in pregnancy or labor. In contrast to the American legal system, no special provision relates to the state of pregnancy. Without any specific regulations for pregnant women, Canadian law treats the incompetent pregnant woman who issued an advance directive while competent the same way as it treats other incompetent patients. That is to say, it respects the patient’s right to control her care. Canadian advance directive (general) legislation covers ten provinces and one territory. Each province uses slightly different legal language, and each has different laws for making and relying on these powerful documents. There is no legislation for the advanced directives in Nunavut (NU). 1717
  • 18. PROVINCE/ TERRITORY INSTRUMENT YEAR CITATION Alberta AB Act 2000 R.S.A., Ch. S-19, §7 British Columbia BC Act 1996 R.S.B.C, ch. 405 Manitoba MB The Health Care Directives and Consequential Amendments Act 1992 S.M., ch. 33 New Brunswick NB Informed Person Act 1973 R.S.N.B ch. I-8 Newfoundland NL Act 1995 S.NFLD., ch. A-4.1 Nova Scotia NS Medical Consent Act 1989 R.S.N.S., ch. 279,§ 1 Ontario ON Substitute Decisions Act 1992 S.O., ch. 30 Prince Edward Island PE Consent to Treatment and Health Care Directives Act 2000 R.S.P.E.I., ch. 10, amended in ch. 5 Quebec QC Civil Code of Quebec 1991 S.Q., ch. 64, § I Saskatchewan SK Health Care Directive and Substitute Health Care Decision Makers Act 1997 S.S., ch. H-0.001 Yukon YK Enduring Power of Attorney Act 2002 R.S.Y.T, ch. 73 1818
  • 19. IN BRITAININ BRITAIN Advanced directives are valid under the British Commonlaw and are made freely, without undue influence. In England and Wales, one may make an advance directive or appoint a proxy under the Mental Capacity Act 2005. This is only for an advanced refusal of treatment, when the patient lacks mental capacity. [11] If a pregnant woman temporarily loses judgmental capacity, an advance directive would be effective only if it specifically mentions pregnancy. In case of a doubt, some scholars argue that a directive refusing all of the recommended forms of medical treatment is unlikely to be regarded, because the courts may assume that “the woman had not addressed her mind to the circumstances which have arisen.” [12] The British Law Commission's view is identical. It is a battery under the British Law to treat a patient against her express consent. Implied consent is not enough. The Royal College of Obstetricians & Gynecologists (RCOG) recommends: "if an incompetent pregnant woman, who was fully informed, refused treatment during pregnancy in advance, her wishes should be respected even at the expense of the fetus." [13] (11) Johnston C, Liddle J (2007). The Mental Capacity Act 2005: a new framework for healthcare decision making. Journal Medical Ethics; 33 (2): 94–97 (12) Nicola S (2000). Maintaining a pregnancy following loss of capacity. Medical Law Reviews; 8: 275 -279 (13) RCOG (1996). Court-authorized obstetric intervention: A consideration of the Law and Ethics; §§ 3.4.2, 4.2 1919
  • 20. SEMINAL CASESSEMINAL CASES BLUEBOOK CITE: University Health Services, Inc v. Piazzi, Civ. Action No. CV 86-CCV-464 (Super. Ct,. Richmond County, Ga. 1986) FACTS: Donna Piazzi, 52, was five months pregnant when she was found in a restroom in coma. She was brought to the hospital brain-dead and with a living fetus. Her wishes were unknown, as there was no living will left. PROCEDURAL HISTORY: In July 1986, the University Health Services, Inc petitioned for a declaratory judgment that life support systems should be maintained for Donna Piazzi in order to preserve life of her unborn fetus. The court granted the petition to continue life-support procedures on a brain- dead pregnant Piazzi, contrary to the request of the patient’s husband and family. The family appealed. ISSUE: Whether sustaining life support of a pregnant woman in a permanent vegetative state to safe fetus against the family's wish was constitutional. HOLDING: According to the Georgia Law, the woman was dead and therefore had no protective privacy interest. Because the pregnancy clause of Georgia legislation determines that the living will would be ineffective during pregnancy, the woman’s wishes regarding the living will are irrelevant. JURISPRUDENCE: O.C. G. A. § 9-4-5 DISPOSITION: AFFIRMED REASONING: Donna Piazzi did not leave any directive. Based on the state pregnancy clause, the woman was dead under the Georgia Law. 2020
  • 21. DISCUSSION IN RE PIAZZIDISCUSSION IN RE PIAZZI Medical technology and scientific knowledge enables healthcare providers maintain a brain-dead pregnant woman on life- support for a successful delivery of her fetus. However, the legality of such practice as well as its ethical implications remain ambiguous. The permissibility of such an action is analyzed through discussion of other legal situations dealing with similar aspects, namely Abortion Law & Human Tissue Gift Law. These issues include the moral and legal status of living (viable, non viable) fetus; dead fetus; interest to life; pragmatical obstacles derived from the proposed procedure; the legal requirement of consent; physician-patient relationship, and the status of next-of-kin in such situation. The Piazzi ruling has led commentators to assume that the court’s reliance upon the living will statute indicates that it might reject the claim that the pregnancy clause is unconstitutional. Piazzi ruling was notable for what it didn't say. The court did not reflect on the constitutionality of the pregnancy clause. 2121
  • 22. CASE 2CASE 2 BLUEBOOK CITE: DiNino v. State 102 Wn.2d 327 (1984) BACKGROUND: In 1979, the WA Legislature enacted a Natural Death Act (NDA) according to which adult individuals have a fundamental right to make decisions concerning medical care, including the decision to forgo life-sustaining treatment. The NDA created a procedure whereby individuals could execute a directive which provides for the withholding or withdrawal of life-sustaining procedures in terminal conditions. The Act defines that the "directive" may include the following specifics: - “If I have been diagnosed as pregnant and that diagnosis is known to my physician, this directive shall have no force or effect during the course of my pregnancy." In her living will, plaintiff J.L. DiNino directed that her will was the final expression of her “legal right to consent to termination of any pregnancy,” and that contrary to the Washington Natural Death Act it would “have full force and effect during the course of her pregnancy.” 2222
  • 23. - continued -- continued - PROCEDURAL HISTORY: Ms. DiNino and her physician brought a suit against the state under the Uniform Declaratory Judgments Act, RCW 7.24.020, seeking a declaration that DiNino's directive was valid and enforceable and that no physician would be civilly or criminally liable for following it. In the alternative, they sought a declaration that the Act NDA-RCW 70.122.030(1)(c) was unconstitutional and void. DiNino argued that her constitutional right to privacy was infringed under the Act in two respects: (1) the provision directly inhibited her right to choose to have an abortion, and (2) it directly infringed upon her right to choose to forego medical treatment. The state argued that the directive was invalid as written and that the subsection was constitutional. Both parties moved for summary judgment. The Superior Court of King County (WA) granted DiNino partial summary judgment, declaring the pregnancy provision of the Natural Death Act unconstitutional because "the subsection inhibited a woman’s right to exercise control over her reproductive decisions; therefore, the provision violated DiNino’s fundamental right of privacy." The Superior Court, however, denied the declaration of validity of a woman’s directive because it attempted to exercise full control over DiNino’s reproductive decisions beyond the point where the state has a legitimate interest in such decisions. Both DiNino and the state appealed to the Supreme Court of WA. 2323
  • 24. - continued -- continued - ISSUES: (1) Whether the pregnancy provision in the NDA, RCW 70.122.030(1) (c) was unconstitutional; (2) Whether DiNino's advanced directive was valid and enforceable and that no physician would be civilly or criminally liable for following it under the Uniform Declaratory Judgments Act. JURISPRUDENCE: Uniform Declaratory Judgments Act, RCW 7.24.020. DISPOSITION: The Court of Appeals REVERSED the Trial Court decision on both issues. REASONING: The Court of Appeals ruled that this case presented a hypothetical, speculative controversy, and did not present "a justiciable controversy." The record did not show that women are prevented from executing directives, that physicians refuse to comply with directives that are not modeled after the statutory directive, or that the NDA, in the abstract, directly prevents a woman from obtaining an abortion or choosing to forgo medical treatments. Without a factual controversy the Justice believed that an advisory opinion would not be beneficial to the public or to other branches of government. OUTCOME: DiNino and her fetus died two days after the forced medical treatment. 2424
  • 25. DISCUSSION IN RE DiNINODISCUSSION IN RE DiNINO Question (1): Why the woman did not benefit from the court's decision? Answer (1): DiNino could not benefit from the court’s decision because she (and her fetus) died two days after the forced medical treatment. Question (2): Did the court avoid the woman's basic right by: - Imposing undue burdens on the right to terminate pregnancy and make medical decisions under the 1st, 4th, 9th, and 14th Amendments? - Depriving women of liberty (bodily integrity) without due process – thus violating the 14th Amendment? - Requiring an expression of adherence to the state’s policy protecting fetal life? Answer (2): The court stated that Ms. DiNino or her physician had to make a better effort to look for another physician who would be willing to place the directive in her file. The real controversy was between DiNino and her physician. Question (3): Did DiNino’s physician have a duty to look for another physician? Will the latter be immune from any possible liability? Answer (3): This complexity suggests that the laws ruling advanced directives in obstetrics must have provisions as to the third party (non-proxy) liability issues. 2525
  • 26. DISCLAIMERDISCLAIMER This presentation does not constitute a legal advice. The burden for determining its completeness, suitability or appropriateness for intended use or purpose rests solely on the reader accessing this information. The author declares no commercial, strategic, or financial interest or trusteeship with the names of entities either used or omitted. 2626