Introduction to Medical Ethics

Introduction to Medical Ethics
Informed Consent & Advance Directives
Developed by:
Barry M. Kinzbrunner, MD
Chief Medical Officer
VITAS Healthcare
Miami, FL

Goals
• To provide an overview of medical ethics
• To demonstrate how informed consent and advance directives serve
to allow health care decision making to be carried out in an ethical
fashion

Objectives
At the end of this presentation, the participant will be able to:
• Define medical ethics and its various principles
• Articulate the legal and ethical bases for informed consent
• Comprehend the legal and ethical bases for advance directives
• Demonstrate an understanding of the legal and ethical bases for
surrogate decision making

Medical Ethics
Medical ethics is the discipline of evaluating the merits, risks
and social concerns of activities in the field of medicine. Many
methods have been suggested to help evaluate the ethics of a
situation. These methods tend to introduce principles that
should be thought about in the process of making a decision.
http://www.wordiq.com/definition/Medical_ethics

Medical Ethical Values
• Autonomy
• Beneficence
• Non-maleficence
• Justice
- Social
- Distributive

Medical Ethical Values (Cont.)
• Autonomy
– The right of an individual to choose among various options of treatment
free of coercion
• Beneficence
– The obligation to provide therapy with intent of doing good for the
individual
• Non-maleficence
– Providing therapy without intent of causing harm. Since all interventions
have risks, the basis of this is to minimize the potential risks and
avoidable harms

Justice
• Social Justice
– Provision of therapies realizing that all resources in a society are
limited and not everything is available to everyone
• Distributive Justice
– Interventions are provided as equitably as possible
Medical Ethical Values (Cont.)

Principle of Double Effect
Attributed to St. Thomas Aquinas
• The act itself must be morally good or at least indifferent
• While there is a risk of the bad effect occurring, it is not
guaranteed to occur
• The good effect must come from the intervention, NOT from the
bad effect
• The good effect must be sufficiently desirable as to outweigh the
potential risk of the bad effect
Connell, FJ: “Double Effect, Principle of,” New Catholic Encyclopedia (Vol 4),
New York: McGraw-Hill, 1967, pp. 1020–2.

Withdrawing vs. Withholding Care
Withdrawing care
• Decision to remove an active intervention that is already
being provided to a patient
Withholding care
• Decision not to provide an active intervention to a patient

Withdrawing vs. Withholding Care (Cont.)
• In medical ethics today, there is no distinction made between withdrawing
and withholding care in reference to the patient with a terminal illness
• In the past, withholding was considered ethically superior to withdrawing
• Most recently, ethicists are espousing the position that withdrawing is
ethically superior to withholding, since a trial of treatment gives information
on its efficacy for the particular patient

A Hypothetical Case
Mrs. H
• 83-year-old Hispanic female
• Alert and oriented
• Terminal advanced COPD
• Family agrees to hospice care for patient provided:
– Patient not be told she is dying and on hospice
– Hospice staff remove name badges when visiting
– Hospice staff not tell patient why they have come to see her
Question:
• Does this violate the concept of informed consent?

A Hypothetical Case (Cont.)
During the initial visit by hospice staff:
• Patient is given hospice papers and signs them without reading them
• Patient is told by family to sign papers without reading them,
which she does
• Family member signs papers for patient without the patient even knowing
this was done
Question:
• Which of these scenarios, if any, violate the concept of informed consent?

Informed Consent
• Implementation of the ethical principle of autonomy
• Accords individuals the option of accepting or refusing medical treatment
• Informed consent doctrine confers two separate and connected rights:
– The right to receive adequate information to make an intelligent choice about
whether to accept or refuse a proposed treatment
– The right to refuse medical treatment for any reason, including quality of life
based on the specific individual’s judgmenta
• To be considered legally valid, refusal of treatment must be based upon an
informed decision of the patient, after s/he has received all information material to
making such a decision

Informed Consent (Cont.)
Origins of the Informed Consent Doctrine
• Right to be free from nonconsensual interference with one’s person
• Morally wrong to force one to act against his or her will
• Serves six functions
– Protect individual autonomy
– Protect patient status as human being
– Encourage physicians to carefully consider decisions
– Avoid fraud or duress
– Foster rational decision-making by patients
– Increase public involvement in medicine

Legal framework for Informed Consent
• Historically was based on “Battery Theory”
– Unwanted touching
– Not operative today in almost all jurisdictions
– May be operative if there is no consent at all (i.e. operating on the wrong knee)
• Negligence: Operative in virtually all jurisdictions
– Prima facie case based on:
• Duty to disclose information
• Failure to disclose (unless statutory exception met)
• If information had been disclosed, patient would not have consented to procedure
Injury and damages

Duty to disclose standards
• Professional standard
– Physician has disclosed information that a reasonable or prudent doctor
would have disclosed under similar circumstances
• Patient-need standard
– What a reasonable person would want to know; information that would
be material to a patient
• States with statutes usually adopt the “Professional Standard”
• Case law is split 50-50 on which standard to follow

What must be disclosed
• The condition or diagnosis
• Nature and purpose of treatment
• Risk of treatment
• Treatment alternatives which includes:
– Things that are already known
– Things that everybody should know
– Option of no treatment
– All alternatives do not have to be disclosed

Exceptions to the General Rule of Disclosure
• Patient is unconscious or otherwise incapable of consenting
(emergency treatment)
– Harm from failure to treat is imminent
– Outweighs any harm threatened by proposed treatment
• Therapeutic privilege
– Risk disclosure poses such a threat of detriment to a patient as to become
unfeasible or contraindicated from a medical point of view
– Does not accept the paternalistic notion that the physician may remain silent
because divulgence might prompt the patient to forego therapy the doctor
believes the patient must receive

Causation issues
• Disclosure of information would have caused the patient to refuse to
undergo the treatment
– Subjective: The patient states that if s/he had known, s/he would have
refused the intervention. This standard is impossible to prove because
anyone could say they would have refused if they had known
something they claim was not disclosed
– Objective: One must prove that a reasonable patient would not have
agreed to the intervention if s/he had known
• Most states have adopted the objective standard

Hospice and Informed Consent
• Federal – Hospice §COP 418.62 Condition of Participation: Informed Consent
“A hospice must demonstrate respect for an individual’s rights by ensuring that an
informed consent form that specifies the type of care and services that may be
provided as hospice care during the course of the illness has been obtained for
every individual, either from the individual or representative as defined in §418.3”
• Representative
An individual who has been authorized under state law to terminate medical care or
elect or revoke the election of hospice care on behalf of a terminally ill individual
who is mentally or physically incapacitated

Hospice and Informed Consent
General Provisions for Valid Medical Consent
Florida State Law  §766.103 Fla. Stat.
• Consistent with accepted medical practice standards among similar trained and
experienced medical professionals
• Based on information provided by the medical profession, a reasonable person
would have a general understanding of the procedure, medically acceptable
alternatives, substantial risks and hazards.
• Based on all surrounding circumstances, a reasonable person would have
undergone the treatment
• The consent is validly signed by the patient (if mentally and physically competent
to give consent) or by another authorized person

During the initial visit by hospice staff:
• Patient is given hospice papers and signs them without reading them
• Patient is told by family to sign papers without reading them, which she does
• Family member signs papers for patient without the patient even knowing
this was done
Question:
• Which of these scenarios, if any, violate the concept of informed consent?

Mrs. H
• Unresponsive
• Terminal dementia
• Patient is referred for hospice care
Questions:
• Is this patient medically competent to make a decision?
• Who gets to decide and provide “informed consent” for the patient?
• Is the decision consistent with what the patient would have wanted if she was
able to make her own decisions?
• How could we know?

When can a “representative” be substituted for a patient in the decision
making process?
Determining a patient’s competence
• Addressed by state law
• In Florida it is the primary responsibility of the attending physician
• A second physician evaluation may be obtained if the attending is unsure
• If there is a dispute, a judicial hearing may be scheduled although this is rarely
if ever required
• If a determination is made—either in the clinical setting or judicially—that a patient lacks
decision-making capacity, the patient cannot make decisions about his or her medical
treatment

Case of Karen Ann Quinlan
Early to mid 1970s
• The patient, Karen Ann Quinlan, a woman in her early 20s, suffered irreversible anoxic
brain damage resulting in a state of permanent unconsciousness now known as
permanent (or persistent) vegetative state (PVS)
• Her life was sustained for just over a year on a ventilator, with artificial nutrition and
hydration and other forms of medical and nursing care
• Her family came to the conclusion that being kept alive artificially was not what she
herself would have wanted done
• Physicians refused to honor the wishes of the family

Case of Karen Ann Quinlan (Cont.)
• Judicial relief was sought
• Landmark 1976 decision of the NJ Supreme Court
– As her legal guardian, Mr. Quinlan had the authority to have the ventilator withdrawn
– The legal basis for this decision was Ms. Quinlan’s constitutional right to privacy
– The fact that Ms. Quinlan was unconscious and unable to decide for herself did not mean that
she forfeited these rights, the New Jersey Supreme Court held
– It only meant that these rights would have to be exercised by someone else  in this case her
father
• This was the first time that an individual’s right to refuse life-sustaining medical treatment was
affirmed by an American appellate-level court
• Also supports concept of “representative” decision making when a patient is medically
incompetent

Case of Nancy Cruzan
Mid-1980s
• A young woman named Nancy Beth Cruzan fell into a PVS after a devastating anoxic brain
injury
• The family requested that artificial nutritional support and hydration be discontinued
• The Missouri Supreme Court ruled
– Guardians did not have the authority to terminate life-sustaining medical treatment on the
basis of indirect or hypothetical reasoning about what the patient would have wanted
– Surrogate treatment decisions must be based on clear and convincing evidence of what
the patient would have wanted
– If there is no clear and convincing evidence of a patient’s wishes, the guardian is obligated
to act in the patient’s best interests, and for the Missouri Supreme Court, this meant the
continuation of life and of medical life support

Case of Nancy Cruzan (Cont.)
• The Cruzan family appealed to the United States Supreme Court
• The Court ruled that U.S. Constitution confers a right (“liberty interest”) to refuse
medical treatment, even life-prolonging medical treatment (including artificial
nutrition and hydration)
• However, it also held that states did not violate this constitutional right by requiring
clear and convincing evidence of the patient’s wishes when the patient lacked
decision-making capacity
• The Cruzan case marked the end of a period of legal consolidation because this
was the first time that the U.S. Supreme Court had addressed end-of-life medical
decision making in the light of the Constitution and established a right to refuse
medical treatment

Advance Directives
The requirement of the Missouri Supreme Court,
upheld by the US Supreme Court, that allowed
the need to establish “clear and convincing
evidence” of the patient’s wishes when the
patient lacked decision-making capacity led to
the development of advance directives and the
state and federal laws defining them

Advance Directives
• Advance directives are documents that tell your physician and
other health care providers what kind of care you desire or do not
desire to receive if you become unable to make medical decisions
• Advance directives can be designed to delineate what care you do
or do not wish based on the severity of illness and/or the likelihood
of recovery

Advance Directives (Cont.)
Types of Advance Directives
• Living will
– Instructions by the patient on interventions s/he desires or does not desire
should s/he be in a terminal condition or a PVS or other irreversible neurological
condition (in some states) and cannot express his or her wishes
• Durable Power of Attorney for Health Care
– Designates who will make health care decisions if one becomes
unconsciousness or otherwise incompetent to make medical decisions
(also known as a Health Care Proxy)
• Combination of both
• Each state has its own set of laws governing advance directives

Mrs. H:
• Unresponsive
• Terminal Dementia
Questions:
• Is this patient medically competent to make a decision?

Advance Directives
What happens if there is no advance
directive document and a patient is
incompetent and unable to make a medical
decision?
Who gets to decide, and how is the
decision made?

Case of Terri Schiavo
1990
• Terri Schiavo, a 26-year-old female, suddenly collapsed in her apartment and
suffered a cardiac arrest
• Despite being resuscitated successfully from the point of view of
cardiopulmonary function, she suffered significant anoxic brain damage
• Due to an inability to swallow, a percutaneous gastrostomy (PEG) feeding tube
was placed
• Lack of a neurologic recovery led to a diagnosis of persistent
vegetative state
• As Mrs. Schiavo did not have an advance directive (either a living will or durable
power of attorney) her husband was granted legal guardianship, without
objection from her parents

Case of Terri Schiavo (Cont.)
Mid-1990s to about 2000
• Attempts at aggressive rehabilitation were unsuccessful and it became
clear to the husband that his wife’s condition was permanent and would
not improve
• He also believed that she would not have wanted to live in a persistent
vegetative state
• On that basis, Mr. Schiavo decided that he wanted his wife’s feeding tube
removed
• Mr. and Mrs. Schindler, the parents of Terri Schiavo, disagreed with her
husband’s decision

• Because consensus could not be reached, Mr. Schiavo petitioned the Florida
courts to appoint a health care “proxy” in order to make an independent decision
on his wife’s medical condition and whether or not it would be reasonable to
discontinue feeding her through the PEG tube
• The court proxy decided that the patient’s condition was irreversible
• The husband demonstrated to the satisfaction of the court that his
wife would not have wanted to be kept alive in this state. The court therefore
agreed with the husband’s position that the feeding tube
could be removed
• The patient was admitted to an inpatient hospice facility for this purpose

• However, the parents appealed this decision at every level within the
Florida court system, leading to the feeding tube removal being
postponed numerous times so the case could be adjudicated. In all
instances, the initial decision was upheld
• This led, in 2003, to the removal of Terri Schiavo’s feeding tube
• The parents appealed to the Florida legislature, and a law was passed
and signed by the state governor granting him the authority to order
Terri’s feeding tube replaced, which was done

• Over the next 15 months, continued appeals and stays were granted at the
state level, leading to the finding by the Florida Supreme Court that the law
allowing the feeding tube to be replaced was unconstitutional
• The parents attempted to appeal to the US Supreme Court, and special
legislation was passed by the US Congress and signed by the President of
the United States to allow the US Supreme Court to hear the case
• However, the US Supreme Court refused to hear the case and the original
court, standing by its prior decision, ordered the feeding tube removed on
March 18, 2005
• Terri Schiavo passed away on March 31, 2005

What was the central issue in the Terri Schiavo case?
• Right to live vs. right to die
or
• Who gets to decide when there is no advance directive

Health Care Surrogate
• Surrogate: As referenced in U.S. law, a person who makes decisions foran other
• In the context of health care it is the term used to refer to a person who has the legal
authority to make decisions for an incompetent patient
• Surrogates may be determined in one of several ways:
– Patient-designated surrogate: through a DPOA type of advance directive
– Judicially-designated surrogate: appointed by a judge and known as a “Court-
Appointed Guardian”
– Statutorily-designated surrogates: lists family members and other persons, in
order of priority, who are authorized to make medical decisions for an incompetent
patient who has not designated a surrogate, and for whom there is no court-
appointed guardian

Health Care Surrogate (Cont.)
Florida Surrogate Statute Order of Priority
• Judicially appointed guardian of the patient if already named
– Appointment not required if not named
• The patient’s spouse
• An adult child of the patient
– If the patient has more than one adult child a majority of the adult children who are
reasonably available for consultation
• A parent of the patient
• The adult sibling of the patient
– If the patient has more than one sibling, a majority of the adult siblings who are
reasonably available for consultation

• An adult relative of the patient
– who has exhibited special care and concern for the patient
– who has maintained regular contact with
the patient
– who is familiar with the patient’s activities, health and religious
or moral beliefs
• A close friend of the patient

• A clinical social worker licensed pursuant to chapter 491, or who is a graduate of a
court-approved guardianship program
– Chosen by the provider’s bioethics committee (or another committee if the
provider does not have one) and not employed by the provider
– The proxy will be notified that, upon request, the provider shall make available a
second physician, not involved in the patient’s care to assist the proxy in
evaluating treatment
– Decisions to withhold or withdraw life-prolonging procedures will be reviewed by
the facility’s bioethics committee
– Documentation of efforts to locate proxies from prior classes must be recorded
in the patient record

Standards for Surrogate Decision Making
• Informed consent must be obtained from the patient’s surrogate
• Since the goal of informed consent is to protect patient autonomy, the
surrogate must determine what the patient’s wishes are about treatment,
not what treatment is best for the patient in the surrogate’s opinion
• What is the standard as to the degree of certainty the surrogate should
have regarding the decisions made? This differs from state to state

• Subjective standard
– Also known as “Clear and Convincing Evidence” standard
– Surrogate should be virtually certain that this is what the person
would have wanted
– Surrogate is acting as a conduit for expressing those wishes
– Written document preferred
– Oral evidence may be acceptable

• Substituted Judgment Standard
– Pennsylvania Supreme Court ruled that simply because a surrogate was a
patient’s mother she would know what he wanted even though he had never
expressed any views on the subject
• Best Interest Standard
– In the absence of any clear knowledge or any knowledge of what the patient would
have wanted, the surrogate is empowered to make a decision that the surrogate,
in good faith, believes is in the best interests of the patient rather than one that
effectuates the patient’s own wishes

What was the central issue in the Terri Schiavo case?
• Right to live vs. right to die
or
• Who gets to decide when there is no advance directive

Mrs. H
• Unresponsive
• Terminal dementia
Question:

Introduction to Medical Ethics

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Introduction to Medical Ethics

Similar to Introduction to Medical Ethics (20)

More from VITAS Healthcare

More from VITAS Healthcare (20)

Recently uploaded

Recently uploaded (20)

Introduction to Medical Ethics