Ulysses Pact in Obstetrics (by Naira Matevosyan)

ULYSSES PACT IN OBSTETRICSULYSSES PACT IN OBSTETRICSHLTH 7660: THE LAW OF PATIENT CARE

February 12, 2015

Naira Roland Matevosyan, MD, PhD

Candidate for Masters of Science in JurisprudenceCandidate for Masters of Science in Jurisprudence

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CONTENTSCONTENTSAdvance Directives - 3Capacity v. Competence - 4 - 5

Privacy v. Confidentiality - 6Will-Grammar and Extensions - 7Will Effect & Termination - 8

Ulysses Contract - 9The 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 DIRECTIVESThe 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

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CAPACITY v. COMPETENCECAPACITY v. COMPETENCEBioethics 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. COMPETENCEThe 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

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WILL GRAMMAR & EXTENSIONSWILL GRAMMAR & EXTENSIONSSome 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 & TERMINATIONThe 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 CONTRACTUlysses 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

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IN THE UNITED STATESIN THE UNITED STATES

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STATE LAW CITATION

Alabama ALAdvance directive for health care requires two witnesses.

Not valid if pregnant.§§ 22-8A-1 to 22-8A-13

Arkansas ARBoth 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 CTBoth living will and DPOA

require two witnesses. Not valid if pregnant.

§§ 19a-570 to 19a-580d

1111

STATEcontinued

LAW CITATION

Georgia GAAdvance directive for health care requires two witnesses.

Not valid if pregnant.§§ 31-32-1 to 31-32-12

Hawaii HILiving 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

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STATEcontinued

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 twowitnesses 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

STATEcontinued

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 NDTwo 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 OKTwo 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 RITwo 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

STATEcontinued

LAW CITATION

South Dakota SDTwo 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 TXDirective to physicians and

DPOA require twowitnesses. Not valid if pregnant.

§§ 166.031 to 166.053

Utah UTAdvance 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 to70.122.920

Wisconsin WIDeclaration to physicians and

medical DPOA require two witnesses. Not valid if pregnant.

Title 20, Chapter 54, §§ 5441 to 5447

Wyoming WYTwo 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. LIABILITYUlysses 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).

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PRESUMPTION v. PROBABILITYPRESUMPTION v. PROBABILITYRebuttable 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).

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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 MBThe 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,§ 1Ontario 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 SKHealth 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

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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

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SEMINAL CASESSEMINAL CASESBLUEBOOK 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. § 9-4-5DISPOSITION: AFFIRMEDREASONING: 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 PIAZZIMedical 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 2BLUEBOOK 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.

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DISCUSSION IN RE DiNINODISCUSSION IN RE DiNINOQuestion (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