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Introduction to Medical Ethics Informed Consent & Advance Directives Barry M. Kinzbrunner, MD Chief Medical Officer Vitas Innovative Hospice Care Miami,

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Presentation on theme: "Introduction to Medical Ethics Informed Consent & Advance Directives Barry M. Kinzbrunner, MD Chief Medical Officer Vitas Innovative Hospice Care Miami,"— Presentation transcript:

1 Introduction to Medical Ethics Informed Consent & Advance Directives Barry M. Kinzbrunner, MD Chief Medical Officer Vitas Innovative Hospice Care Miami, FL

2 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.

3 Medical Ethical Values Autonomy Beneficence Non-Maleficence Justice –Social –Distributive

4 Medical Ethical Values Autonomy –The right of an individual to choose between various alternatives presented to them Beneficence –The obligation to provide and accept beneficial treatment Non-maleficence –Avoidance of harm –Question of how much of an effect it plays in secular ethics since most treatments have risks

5 Medical Ethical Values Justice Social Justice –Determining what is good for the society as a whole Distributive Justice –The distribution of limited resources.

6 Principle of Double Effect The act itself must be morally good or at least indifferent. The agent may not positively will the bad effect but may merely permit it. If he could attain the good effect without the bad effect, he should do so. The bad effect is sometimes said to be indirectly voluntary. The good effect…must be produced directly by the action, not by the bad effect. Otherwise, the agent would be using a bad means to a good end, which is never allowed. St Thomas Acquinas. New Catholic Encyclopedia, vol 4, 1967 (internet edition).

7 Principle of Double Effect The good effect must be sufficiently desirable to compensate for the allowing of the bad effect. In forming this decision many factors must be weighed and compared, with care and prudence proportionate to the importance of the case. Thus, an effect that benefits or harms society generally has more weight than one that affects only an individual; an effect sure to occur deserves greater consideration than one that is only probable; an effect of a moral nature has greater importance than one that deals only with material things St Thomas Acquinas. New Catholic Encyclopedia, vol 4, 1967 (internet edition).

8 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

9 Withdrawing vs. Withholding Care In medical ethics today, there is no distinction made between withdrawing and withholding care. In the past, withholding was considered ethically superior to withdrawing. Most recently, ethicist 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.

10 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?

11 A Hypothetical Case 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?

12 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 individuals judgment. –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.

13 Informed Consent 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

14 Informed Consent 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

15 Informed Consent 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 on which standard to follow

16 Informed Consent 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

17 Informed Consent 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

18 Informed Consent 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

19 Informed Consent Hospice and Informed Consent Federal-Hospice §COP 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.

20 Informed Consent Hospice and Informed Consent General Provisions for Valid Medical Consent Florida State Law- § 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.

21 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?

22 A Hypothetical Case 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?

23 A Hypothetical Case Mrs. H 83 year old Hispanic female 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?

24 Informed Consent 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 can not make decisions about his or her medical treatment.

25 Case of Karen Ann Quinlan Early to mid 1970’s The patient, Ms. 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

26 Case of Karen Ann Quinlan 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

27 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.

28 Case of Nancy Cruzan 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.

29 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.

30 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.

31 Advance Directives 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

32 A Hypothetical Case Mrs. H 83 year old Hispanic female 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?

33 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?

34 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.

35 Case of Terri Schiavo 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.

36 Case of Terri Schiavo 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, and 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.

37 Case of Terri Schiavo 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.

38 Case of Terri Schiavo 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, Terri Schiavo passed away on March 31, 2005.

39 Case of Terri Schiavo 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

40 Health Care Surrogate Surrogate: A person who makes decisions for another is referred to in American law. 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.

41 Health Care Surrogate 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

42 Health Care Surrogate 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 withdrawn 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.

43 Health Care Surrogate 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.

44 Health Care Surrogate Standards for Surrogate Decision Making 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

45 Health Care Surrogate Standards for Surrogate Decision Making 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.

46 Case of Terri Schiavo 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

47 A Hypothetical Case Mrs. H 83 year old Hispanic female Unresponsive Terminal Dementia Patient is referred for hospice care Question: 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?


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