Ethics and Legal Issues in Palliative Care

Ethics and Palliative Care

Over the last decades, technology and scientific advances, the acknowledgment of
new rights, social changes, and the use of patient advocacy have influenced the
medical approach to management of patients with advanced disease, particularly
those who are near death. Ethical and legal considerations in decision-making and
application of care must be addressed in this process. The need to address ethical
concerns while striving to match technical aspects of care with more humanistic
aspects is fundamental in palliative medicine. Its philosophy is global,
multidimensional and centered on the patient and family.
The Department of Pain Medicine and Palliative Care at Beth Israel Medical Center
supports this multifaceted approach. Much attention is given to end-of-life issues and
related ethical dilemmas. This section presents some of the difficult ethical and legal
issues that patients, families and health care providers face in palliative care. Each
aspect is discussed briefly.
Ethics and Law
The ethics of care requires a delicate balance between the conventional practice of
medicine and the wishes of the patient, appreciating that each human situation is
unique. Not only should treatment options and likely outcomes be considered, but
also patient values, hopes and beliefs. Patients and families must be properly
informed to make appropriate treatment decisions and help reset the goals of care at
all stages of the illness.
Every palliative case presents its own ethical dimensions and dilemmas. The
following case illustrates the diverse ethical and legal issues embedded in a common
palliative care situation.
Mr. W. was a 50-year-old construction worker, separated from his wife (though still
legally married) and with a teenage child. He had a history of laryngeal carcinoma
diagnosed one year before. He had a total laryngectomy and received radiation
therapy, but the disease recurred. He was admitted to the hospital
for what turned out to be a final 7 weeks of hospitalization. His
admission was initially prompted by increased shortness of breath
and facial swelling following chemotherapy. His hospital stay was
complicated by a left carotid erosion for which he had a bedside
carotid ligation. He spent 2 weeks in the medical intensive care unit
(MICU) for stabilization and treatment of pneumonia. Mr. W. had
elected the "Do-Not-Resuscitate" option.
His hospital course was marked by increased pain, facial swelling, periodic seizures, a
second pneumonia and progressive weakness. At all times, he was bed bound and
artificially fed. His pain was relatively well controlled but the facial swelling was
uncontrollable. Communication was possible to some extent through hand signals.
Decisions were made after lengthy explanations to the patient and his wife, his
designated health care agent.

In the final weeks of life, Mr. W.'s condition further deteriorated. His ability to
communicate markedly decreased. In response to his enormous suffering, palliative
care staff recommended sedation for Mr. W. Although his wife supported the decision,
several nurses and house officers were concerned that such an intervention would go
beyond the boundaries of appropriate symptom management. Mr. W.'s feeding tube
was withdrawn, in accord with symptom control, comfort measures and the patient's
wishes.
The patient, completely unresponsive in the last 5 days of his life, died very
peacefully.
In this complex case, many questions can be raised:
What are the ethical issues?
What constitutes an ethical problem?
Are ethical questions different from legal questions?
Who decides?
How do we define consent?
Are advance directives necessary?
What does it mean to be DNR (do not resuscitate)?
Is withholding and withdrawal of treatment identical? Are they ever acceptable?
Can we ever stop artificial nutrition and hydration?
Is sedation an option at the end of life? How does sedation differ from physicianassisted suicide (PAS) or euthanasia?

This case suggests many more questions than answers. Although the following
overview might simplify the understanding of the multiple issues embedded in a
clinical case, one should remember that ethics cannot be equated with an "easy
recipe" for solving problems. Ethics is a complex domain and needs ongoing learning,
discussion and reflection, essential to the practice of good medicine.
Since ethical decisions are sometimes complex and difficult, in most major hospitals
an ethics committee is available to guide the medical team in the decision-making
process. The modalities of access vary according to the facility. Most ethics
committees are accessible to families, patients and medical teams.
Cardinal Principles
What Is Ethics?
Ethics is a generic term for different ways to examine moral life. Clinical ethics is a
"practical discipline that provides a structural approach to decision-making that can
assist health professionals to identify, analyze, and resolve ethical issues in clinical
medicine" (Jonsen AR, Siegler M, Winsdale WJ. Clinical Ethics. 3rd ed. McGraw-Hill,
NY, 1992). The ethics of a case arises out of the facts and values embedded in the
case itself. Ethics in palliative care is a matter of "practical reasoning" about
individual patients. Although there are many approaches proposed by ethicists for
the analysis and resolution of difficult situations, the most commonly used are
organized around principles, such as respect for autonomy, beneficence, nonmaleficence and justice. The principles are balanced and weighed in any particular
ethical situation. Sometimes they come into conflict and create an ethical dilemma.

What Are the Basic Ethical Principles?

RESPECT FOR AUTONOMY recognizes the right and ability of an individual to
decide for himself or herself based on his or her own values, beliefs and life span.
This implies that the patient may choose a treatment that might differ from the
advised course of care. The patient's decision should be informed and wellconsidered, reflecting his/her values. It is acceptable, for example, that a patient
refuse certain therapy according to his own religious beliefs. Many factors interfere
with the expression and appreciation of the patient's preferences: compromised
competence of the patient, stress of illness, comprehension difficulty, etc. Respect for
autonomy implies truth telling and exchange of accurate information about status,
goals of care, options and expectations.
BENEFICENCE requires that the physician prevent or remove harm,
while doing or promoting good. It is the most commonly used
principle in the application of care. It implies that the health care
team should do positive acts in maximizing the benefits of treatment.
Examples include: delivering effective and beneficial treatments for
pain or other symptoms, providing sensitive support, and assisting
patients and families in any way possible.
NON-MALEFICENCE supposes that "one ought not to inflict harm deliberately."
Violation of this concept may include offering information in an insensitive way,
providing inappropriate treatment of pain or other symptoms, continuing aggressive
treatment not suitable to the patient's condition, providing unwanted sedation, or
withholding or withdrawing treatment.
JUSTICE relates to fairness in the application of care. It implies that patients receive
care to which they are entitled medically and legally. Justice can be translated into
"give to each equally" or "to each according to need" or to "each his due." Different
theories of justice debate what is "due," "equally," or "priority." Organ
transplantation, selection in the emergency room or admission to the inpatient or
outpatient hospice unit are applications of this principle. Who should have priority?
The principle of justice implies a consideration for a common good and societal
considerations.
How Law Differs from Ethics
In the administration of care, one cannot ignore the different legal requirements
relevant to each situation. Although some cases might be defensible under ethical
principles, they might not be permissible under legal provisions. Law is defined as
minimal ethics, in the sense that it is based on the values of a society. It is also the
reflection of a societal consensus on particular issues. It varies from society to
society, from state to state. In the U.S., law is divided into two systems: federal
(across the states) and state (within the state). It can be made by:

Judges (common law)

Example: Supreme Court of the United States recognition for the right to

refuse medical care

Legislatures (statutory law)
Example: Uniform Definition of Death Act
Executive agencies (regulatory law)
Example: Regulations for Protection of Human Subjects of Research
Most end-of-life issues fall under common law (case by case decided by the tribunals,
such as consent/withholding or withdrawal of treatment) or statutory law (different
state law, e.g., physician-assisted suicide/do-not-resuscitate law).
Legal provisions impose limits on decisions that might be ethically sound but
nevertheless risky. They provide a framework to guide certain decisions or practices.
This framework is defined in terms of requirements that need to be fulfilled in order
to avoid liability.
Decision-Making Issues
With modern medicine offering countless new technologies and treatments, health
care decision-making can become a difficult and complex task. Indeed, as the
number of options grows, treatment can vary greatly, even among patients
confronted with the same illness. Decisions should be made according to the goals of
care. If cure is the expected goal, one might want to treat a pneumonia aggressively
with antibiotics, but if quality of life is the primary goal, one might not want to treat
that same pneumonia if it occurs as a terminal event in advanced illness.
Informed Consent
The best treatment decisions have been described by medical ethicists as a
"combination of medical, emotional, aesthetic, religious, philosophical, social,
interpersonal and personal judgments." As a result, patients must take a more active
role in their health care by bringing their history, values, philosophies, strengths and
emotional needs to the decision-making process. They also must have sufficient
information about proposed treatments before making choices. This practice is called
informed consent. It implies an acknowledgment of the patient's ability to decide
(capacity) and communication of information sufficient to assist the patient in
making the best decision under the known circumstances (informed).
Concept of Competency
In order to be valid, consent to care or treatment must be given by a
competent patient. This implies that the person can understand,
reason and evaluate the consequences of the decision and express
his or her desires. The determination of capacity is a matter of
clinical judgment, and there is no consensus on a set of criteria for
its evaluation. Although distinct from capacity testing, mental status
evaluation is often used as a screening tool to assess the patient's
thought processes.
Capacity may fluctuate over time due to fatigue, disease, medication,
the environment, and available information. It is important to remember that

consent is specific to a particular decision and not once and for all. It needs constant
evaluation.
Once a patient is determined incompetent, whether the determination is made
clinically or legally, someone needs to be designated to make decisions for the
patient. This person is generically known as a surrogate who can be court-appointed
(guardian) or patient-appointed (surrogate, agent). In their decision-making, third
parties have to take into consideration previously expressed wishes when available;
otherwise, the best interests of the patient will guide the decision.
Truth Telling: Information to Patient
In order for the patient or his representative to decide a course of treatment, they
need to be adequately informed. Physicians and health care professionals need to
guide their patients with knowledge, truth and compassion. They need to know what
information to provide, how much information to provide, and how to respond to
patients who elect not to have too much information.
Truthful telling of the facts is critical to a patient's ability to make an autonomous
and reasonable decision. Choices made irrationally, based on emotions and/or
insufficient information, can lead to dissatisfaction with the medical system and
increased stress.
The information required for an informed consent includes the patient's medical
condition, the stage in the evolution of the disease, proposed treatments and
alternatives, and the benefits, risks and likely outcomes in each case.
Consent is embedded in the doctor-patient relationship and depends largely upon
communication. Technical language, medical uncertainties, limits to understanding
from the patient, culture and fears can all combine to complicate doctor-patient
communication. The mastering of communication skills is important to the practice of
informed consent.
Advance Directives
Advance directives have been developed as a reaction to heroic measures in
medicine, mainly to set limits on their use. An advance directive is an oral or written
instruction specifying the wishes of a person concerning medical treatment in
anticipation of future inability to decide. It also enables a person to choose another
person (surrogate) to make decisions under the same circumstances. An advance
directive may be expressed through a living will and/or a durable power of attorney
(DPOA).
Living wills are legal documents that specify what treatments would be acceptable or
unacceptable to the patient in case of incapacity. A living will can be general or
specific, including specific scenarios such as artificial nutrition and hydration or any
treatments. Durable power of attorney (DPOA) is a document in which a patient
appoints another person (surrogate) who will decide about the care of that person in
case of incompetence. Surrogates, also referred to as health care proxies or agents,
may be family members or friends.
Living wills and DPOAs can be arranged through various means according to state or
national laws. The surrogate's decision is called a substituted judgment. It should
take into consideration the best interests of the patient and consider the patient's

past behavior, statements, or choices to determine as accurately as possible what

the patient would have wanted. When previous wishes have been specifically
expressed, they should be honored.
Living wills and DPOAs are complementary, since a living will cannot provide for
every possible situation, and a DPOA cannot determine care without information
about the patient's wishes. Today, living wills are legally recognized throughout the
United States, although Massachusetts, Michigan and New York have not enacted
living will laws. Currently, 48 states and the District of Columbia have legislation that
recognizes the appointment of a health care proxy; Alabama and Alaska are the
exceptions. While most Americans support advance directives, 1996 data show that
only 20 to 25% have them in place (Lederberg MS. Ethical Issues in Oncology: A
Psychological Framework. In Holland JC, ed., Psycho-Oncology. New York: Oxford
University Press, 1998, p. 1098.).
Discussion about advance directives should be included in the treatment plan and
should take place with the surrogate present. Advance directives should be updated
regularly to ensure a person's wishes are current and accurate.
Treatment Decision Issues
In the course of an illness, patients and health care agents will need to decide which
treatments they want to pursue. The right to decide has been well acknowledged by
the courts and affirmed by ethics through the recognition of the autonomy principle.
The patient or agent may refuse a treatment or request the cessation of therapy.
Treatment decisions are made according to the goals of care, which vary with the
progression of the disease. At times, cure will be the ultimate goal; however, in
advanced disease, avoidance of premature death, maintenance or improvement in
function, relief of suffering, maintenance of quality of life, and help to maintain
control or promote a good death will become more realistic goals. It is not easy to
determine the appropriate goals. When is it time for palliation? Did we reach the
end-of-life phase? Is there still a place for active treatment?
Patients and family will need guidance in their decision-making process. Information
by the medical team will help to determine what can be done. Patients and agents
will decide, once adequately informed, what their preferences are, and set their
limits of care according to their personal values and goals. Other members of the
team or family and friends can be helpful. Good communication among the
participants involved can help to resolve very difficult decisions.
Among the decisions that may arise in advanced disease are the following:
Withholding or withdrawal of treatment
Do-Not-Resuscitate (DNR)
Sedation at the end of life
Physician-assisted suicide (PAS)
Euthanasia
Each of these issues is controversial. Although much discussion has taken place,
there is no clear consensus.

Withholding and Withdrawal of Treatment

When treatment is considered to be ineffective, disproportionate or of no value to the
patient's quality of life, it may be withdrawn or withheld. Withdrawal of treatment is
defined as the ending of treatment that is medically futile in promoting an eventual
cure or a possible control of the disease. Withholding of a treatment occurs when this
type of treatment is not provided at all. Both practices refer to the proportionality of
treatment under the circumstances: it is no longer reasonable or beneficial to fight
the disease with aggressive medical interventions, since it cannot be controlled. They
are both applicable in the context of life-sustaining therapies, in contrast to lifesaving
therapies. The mere prolongation of life-sustaining treatments is not perceived as a
justifiable goal. By withdrawing or withholding a therapy, one stops or never starts a
treatment that is no longer effective in achieving its goal, thus no longer resisting the
process of death-in-progress, previously delayed by artificial means.
Although withholding and withdrawal of therapies have been described mainly in
situations related to technical interventions (ventilator, hemodialysis), they can also
be applied by extension to chemotherapy, artificial hydration and nutrition as long as
the aim of these therapies is to prolong life beyond expectation, to delay death.
If it is generally accepted that when a treatment is futile (has no benefits) it should
not be offered or given, the difficulty is to define futility. Futility has been variously
defined as "a treatment that does not fulfill its purpose or offers almost no benefits,
a treatment with highly improbable or no real chance of achieving a desirable end."
What type of benefits should be included in the definition (medical, quality of life),
what chances of success are acceptable, remain open to discussion. Advances in
medicine, by defining the probability of success of certain therapies, help to better
define the quantitative aspect of futility. This represents only one of the multifaceted
aspects of this controversial concept. An evaluation in the broader context of
decision-making is needed to reach an adequate decision.
Treatment withholding or withdrawing when a treatment is hopeless or futile is
generally accepted by both the medical and the legal community. At times, health
care professionals may be unable to comply with such a demand. They might have to
transfer the care of their patients to other willing providers, consult their institution's
ethics committee, or look to the courts for guidance. Dealing with these difficult
issues requires a great deal of sensitivity and consideration for the values of all
parties involved. In any case, it is important to discuss the goals of care and to make
sure that the plan of care is well understood in order to avoid any misinterpretation.
In that regard, withholding and withdrawal of treatment need to be clearly
distinguished from physician-assisted suicide and euthanasia.
Do-Not-Resuscitate (DNR)
The impressive technique of resuscitation introduced in the 60s for victims of sudden
cardiac or respiratory arrest has become a common practice in hospitalized patients,
regardless of the underlying disease. Unless a DNR order is specified, patients who
suffer a cardiopulmonary arrest will be "coded." DNR is a direct application of the
right of the patient to refuse an intervention. Although well-acknowledged, many
questions regarding the current use of DNR discussions and orders remain.

Because resuscitation is often perceived as a question of "life and death" with

dramatic consequences, it often tends to be poorly discussed or interpreted, not
addressed, or addressed too late. DNR orders have been developed to encourage
open discussion and patient participation in their care. The discussion focuses on a
specific issue: whether to resuscitate in the case of a cardiac or respiratory arrest. As
in the case of any procedure or treatment, a DNR decision needs to be informed
[explanations of the procedure, benefits, and harms (chances of success or
complications)], and consented (signed). Written documentation is required, mostly
in the form of a signed document by the patient or the surrogate/proxy. It can be
revoked.
CPR and Advanced Illness
In contrast to popular belief, resuscitation is not an easy procedure or one with a
high success rate. It is now known that the survival rate of CPR is about 15% under
the best circumstances (good health status and CPR started early after the arrest).
The survival rate is related to the underlying disease. Almost no patient with
advanced cancer survives to leave the hospital: It is almost never successful in
patients with chronic debilitating illnesses (1%-4%).
CPR and Level of Care
The DNR order is only one element of the care plan. DNR does not preclude the
administration of other therapies. A patient with a DNR order can still continue
intravenous fluids, antibiotics or any other indicated treatments. In each case,
adequate information on the various options should be discussed with the patient or
decision-maker. The discussion about resuscitation should be placed in the broader
context of life-prolonging therapies.
Artificial Hydration and Nutrition
Withholding or withdrawing artificial hydration or nutrition is difficult to address with
the patient or the family because nutrition has such a high symbolic value (it seems
to mean caring, and withdrawal is seen as starvation), and because of numerous
misperceptions. Withholding nutrition can be perceived as neglect, abandonment or
hastening death. An open discussion about the advantages and side effects of
artificial nutrition will help to correct the misconceptions and reassure families in
their decision process. The discourse is rarely neutral and should take into account
emotions, passions, religious beliefs, and the overall goals of care.
Artificial hydration and nutrition have been considered as treatment by the courts
and, as such, are governed by the same legal and ethical medical principles as the
withholding and withdrawal of other treatments. In this way, information about
nutrition and hydration should be part of a larger discussion about life-prolonging
therapies.
As with any treatment, nutrition and hydration have indications and
contraindications. The difficulty is to recognize the appropriateness of these
therapies. In advanced cancer or other debilitating illnesses, some patients benefit
subjectively from artificial nutrition or hydration and others do not. Improvement in
quality of life or survival has not been proven. In certain cases, it becomes clearly
detrimental since it can contribute to increased swelling, increased pulmonary or
other secretions, and worsen the shortness of breath. Each case is unique and
deserves an individual approach.

Sedation in the Imminently Dying ("Terminal Sedation")

Good palliative medicine can alleviate symptoms for most patients with advanced
disease. At the end of life, sedation has been suggested as a means to relieve
difficult symptoms not responding to sound palliative care.
Terminal sedation is defined as the action of deliberately inducing unconsciousness
without deliberately causing death, in order to relieve intractable symptoms. The
treatment is considered for a "refractory symptom," when all other means have
failed and a patient is believed to be imminently dying. The prevalence of terminal
sedation is unknown; a literature survey shows a frequency ranging from 5% to
52%.
The use of this technique is not without controversy. When is a symptom considered
"refractory" (a symptom that cannot be otherwise satisfactorily controlled)? Does this
term only apply to physical symptoms or include existential and psychological
distress? How imminent should death be? What increases in the dosage of analgesics
are consistent with an intent to relieve pain? The acceptability of sedation to
terminally ill patients, physicians, families, other health care providers and society
has not been demonstrated.
If there is no consensus on the indications for sedation, there is also
none concerning the pharmacologic agents to use to induce
sedation. Benzodiazepines and barbiturates are the most widely
used drugs but the list also includes opioids, neuroleptics, and other
psychotropic drugs, or a combination of these agents. Whatever the
agent selected, dose titration to achieve relief is required before
continuing maintenance therapy at the lowest dosage possible.
Sedation is mostly continuous but can be intermittent in certain
circumstances.
The ethical justification for sedation is based on the principle of double effect. It
applies to situations where a desirable effect (good) is linked to an undesirable effect
(bad). To be morally acceptable, such an action must comply with the following
requirements:
the treatment proposed must be beneficial or at least neutral
only the good effect should be intended and must be achieved directly
the beneficial result must outweigh the untoward outcome
The principle's application relies on one's personal and professional integrity and
intention.
Sedation is typically not a goal of opioid therapy. It should be considered an
exceptional therapeutic measure with specific indications. Considering the importance
of its consequences and potential for misunderstandings, sedation should be a
multidisciplinary decision based on an open discussion with the patient or patient's
proxy. Support to family and friends is needed at all times. The use of sedation
should be continually reviewed and documented in the medical record.

Sedation, as a mean to relieve intractable symptoms, possibly to the point of

hastening death, has been acknowledged as justifiable by various medical societies,
bioethics, and more recently, by the United States Supreme Court. To be legally
acceptable, sedation should be carried out in a manner consistent with the intent of
relieving suffering. The action should reflect the purpose. Sedation in the imminently
dying recognizes the right of patients to good palliative care.
Although some have considered sedation in the imminently dying as a form of
euthanasia "in disguise," the two are quite different. They differ in their intent: death
is the unintended, although foreseen result in sedation, as opposed to the intended
result in PAS and euthanasia. They also differ in action: a sedative dose is not a
killing dose. PAS and euthanasia imply recognition not only of the right to be relieved
of suffering, but also of the right to die.