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Slide 1: MEDICO-LEGAL ASPECTS OF INFORMED CONSENT PRINCIPLES & LANDMARK CASES Michael Schwartz, M.D., Associate Professor of Clinical Psychiatry
Slide 2: A physician should not…make gloomy prognostications…For the physician should be the minister of hope and comfort to the sick; that by such cordials to the drooping spirit, he may smooth the bed of death; revive expiring life; and counteract the depressing influence of those maladies, which rob the philosopher of fortitude and the Christian of consolation. Thomas Percival, 1803, Medical Ethics
Slide 3: THE IDEA OF INFORMED CONSENT  THE DECISIONS ABOUT THE MEDICAL CARE A PATIENT WILL RECEIVE ARE TO BE MADE IN A COLLABORATIVE MANNER BETWEEN PATIENT AND PHYSICIAN.  TO PROVIDE THOSE CONCERNED WITH A DEFENSE TO A CRIMINAL CHARGE OF ASSAULT OR BATTERY OR A CIVIL CLAIM FOR DAMAGES FOR TRESPASS TO THE PERSON.
Slide 4: FUNCTION OF INFORMED CONSENT (KATZ&COOPER, 1975)       Promotion of individual autonomy Protection of patients & subjects Avoidance of fraud & duress Encouragement of self-scrutiny by M.D.s Promotion of rational decision making Involvement of the public
Slide 5: JOHN ADAMS (1735-1826)  The proposition that the people are the best keepers of their own liberties is not true. They are the worst conceivable, they are not keepers at all; they can neither judge, act, think, or will, as a political body. – 1765
Slide 6: JOHN ADAMS (1735-1826)  Power must never be trusted without a check.  Letter to Jefferson, February 2, 1816
Slide 7: Is there a right to be left alone?  There is no right to privacy specifically guaranteed by the Constitution  Right to privacy is derived from the     1st Amendment--Free Speech 3rd Amendment--Freedom from occupation by militia 4th Amendment--Freedom from unreasonable search & seizure 5th Amendment--Freedom from self-incrimination, from deprivation of life, liberty or property without due process  9th Amendment--States may impose even greater guarantees of freedom than does the Constitution.
Slide 8: Slater v. Baker & Stapleton (1767)  1. Two medical practitioners held liable for disuniting, without the patient’s consent, a partially healed fracture.  2. The ruling was based upon the fact that it was the custom of surgeons not to operate without consent.  3. Consent was recommended so that the patient could motivate himself to undergo surgery without anesthesia.
Slide 9: Schloendorff v. Society of New York Hospital (1914)  “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.” – Justice Benjamin Cardozo – The patient had consent to an examination under anesthesia, but did not consent to the subsequent removal of a tumor while anesthetized.
Slide 10: The concepT of informed consenT: salgo v. leland sTandford Jr. UniversiTy Board of TrUsTees (1957)  1. Patient who had experienced a spinal cord injury due to a translumbar aortography claimed that he had not been informed of the risks prior to the procedure.  2. Court said that physicians cannot withhold facts that are “necessary to form the basis of an intelligent consent.”
Slide 11: INFORMED CONSENT  LEGAL RULES  ETHICAL DOCTRINES  INTERPERSONAL PROCESS
Slide 12: INFORMED CONSENT: THE LEGAL DOCTRINE  DISCLOSURE OF INFORMATION  COMPETENCY  VOLUNTARY NATURE OF CONSENT
Slide 13: Law of Torts  Subject to the law of the land, no one has the right to interfere with another person’s physical and economic integrity and freedom without that person’s consent.  Civil wrongs (except contracts).
Slide 14: INFORMED CONSENT & TORT LAW  TORT OF TRESPASS  TORT OF NEGLIGENCE     1. Creation of risks resulting in injury 2. Existence of legal duty of care 3. Minimize risk and/or disclose it 4. Failure to disclose without bad outcome does not produce liability.
Slide 15: INFORMED CONSENT & TORT LAW  TORT OF TRESPASS  No unwanted bodily contacts  Right to decide whether contact should occur  Three separate torts: battery, assault, and the tort of false (wrongful) imprisonment.  TORT OF NEGLIGENCE
Slide 16: PENALTIES FOR FAILURE TO OBTAIN INFORMED CONSENT  CURTAILMENT OR LOSS OF HOSPITAL PRACTICE PRIVILEGES  CURTAILMENT OR LOSS OF MEDICAL LICENSE  TRIAL COURT/APPELLATE COURT
Slide 17: INFORMED CONSENT: THE LEGAL DOCTRINE  COMPETENCY  VOLUNTARY NATURE OF CONSENT  DISCLOSURE OF INFORMATION
Slide 18: INFORMED CONSENT: THE LEGAL DOCTRINE  DISCLOSURE OF INFORMATION      1. 2. 3. 4. 5. Nature of illness Treatment proposed Risks & benefits of treatment Risks & benefits of alternative treatments Risks & benefits of no treatment – (Meioses, Roth, and Lidz 1977)
Slide 19: Elements of Disclosure & the “Reasonable Practitioner” Standard: Natanson v. Kline (1960)  Irma Natanson received Cobalt Radiation Therapy for breast cancer.  The radiation was administered at an excessive dose & she sustained widespread chest wall tissue necrosis.  She sued on the basis that she had been inadequately informed of the risks of treatment beforehand.  The initial judgment for the doctor and the hospital was reversed by the Appeals Court and remanded for a new trial.
Slide 20: Elements of Disclosure & the “Reasonable Practitioner” Standard: Natanson v. Kline  Kansas Supreme Court, 1960  The physician is required to disclose only that which a “reasonable medical practitioner” would disclose under similar medical circumstances.  Assumes a consensus within the medical profession.
Slide 21: Elements of Disclosure & the “Reasonable Practitioner” Standard: Natanson v. Kline  Kansas Supreme Court, 1960  Required elements of disclosure:  Nature of the patient’s illness  Nature of proposed treatment & likelihood of its success  Risks of untoward outcomes  Alternative modes of treatment
Slide 22: Elements of Disclosure and the “Reasonable Person” Standard: Canterbury v. Spence (1972)  Canterbury consented to an operation on his lower back. The operation went well, but on the first post-op day, the patient got out of bed, against the doctor’s orders, and fell & became paraplegic.  Sued on the grounds that he was not informed that paraplegia was a potential outcome  The initial verdict for the surgeon and hospital was reversed by the Appeals Court & remanded for a new trial.
Slide 23: The “Reasonable Person” Standard: Canterbury v. Spence  U.S. Circuit Court of Appeals, D.C. (1972)  What a hypothetical reasonable person would want to know.  Patient’s right to reasonable disclosure v. expansion of malpractice liability
Slide 24: The “Reasonable” Patient & Consequences of Declining Procedures: Truman v. Thomas (1980)  The children of Rena Truman sued Dr. Clarence Thomas, for the wrongful death of their mother, who died in 1970 from cervical cancer.  Dr. Thomas claimed that Mrs. Truman repeatedly refused his offer of performing a PAP test (1963-1969), but there was no written documentation of this refusal.  The trial court found for the doctor, but this decision was reversed and remanded for a new trial by the California Supreme Court.
Slide 25: The “Reasonable” Patient & Consequences of Declining Procedures: Truman v. Thomas (1980)  California Supreme Court, 1980  The duty to disclose extends to instances where patient refuses a procedure or treatment (not just when a patient consents).  The doctor was obligated to provide all information material (not commonly appreciated) to the patient’s decision.  Not reasonable for a doctor to assume that the patient appreciates the consequences of his/her decision.
Slide 26: INFORMED CONSENT: THE LEGAL DOCTRINE  DISCLOSURE OF INFORMATION  VOLUNTARY NATURE OF CONSENT  COMPETENCY
Slide 27: INFORMED CONSENT: THE LEGAL DOCTRINE  COMPETENCY  1. Adults presumed competent  2. Minors presumed incompetent  3. Competency de jure v. de facto competency  4. Decisional capacity
Slide 28: ABILITIES RELATED TO COMPETENCE  The ability to express a choice.  The ability to understand information relevant to treatment decision making.  The ability to appreciate the significance of that information for one’s own situation, especially concerning one’s illness and the probable consequences of one’s treatment options.  The ability to reason with relevant information so as to engage in a logical process of weighing treatment options.
Slide 29: ABILITIES RELATED TO COMPETENCE  Patients’ status on these abilities is not an all-or-none matter.  Not all of the ability concepts will be applied in all competence judgements.  The emphasis is on how the choice is made, not the choice itself. Society’s interest in protecting the rights of patients to make autonomous choices requires that their decisions be respected unless they are substantially deficient in their abilities to make the choice.
Slide 30: EXPRESSING A CHOICE  A 57 y.o. man was functioning well until 2 years PTA, when he began to develop symptoms of depression. He proved refractory to pharmacologic treatment and ECT was recommended. When the consultant came to explain the procedure and obtain consent she found him to be catatonic. He was unable to respond to her questions and to engage in a discussion about the procedure.
Slide 31: EXPRESSING A CHOICE  A mildly mentally retarded man was admitted to the hospital for hip replacement surgery following a MVA. He had a history of hospital admissions for brief psychotic episodes, but this was not apparent during this admission. Although he initially consented to the surgery, he withdrew his consent just before the procedure. Over the next three days, he consented and withdrew his consent each day. The psychiatric consultant found him to be incompetent and his parents were asked to make a decision on his behalf.
Slide 32: UNDERSTANDING INFORMATION  A 35 year old acutely psychotic woman, admitted to a psychiatric facility was evaluated for treatment with medication. The psychiatrist discussed the treatment options with the patient. She appeared to be listening but said only “yes” whenever asked if she understood the disclosure. She consented to take the medication. Later in the day, a nurse reported that the patient had asked her if the new vitamin pills that she would be taking with her breakfast would give her more energy.
Slide 33: Understanding the disclosure component of informed consent      1. 2. 3. 4. 5. Nature of illness Treatment proposed Risks & benefits of treatment Risks & benefits of alternative treatments Risks & benefits of no treatment – (Meioses, Roth, and Lidz 1977)
Slide 34: Understanding information  Understanding is the most common ability on which legislatures rely and to which judges refer in their competence judgments.
Slide 35: Understanding information      Sensory integrity Perception: attention, selective awareness Cognitive processing Encoding in memory Intelligence
Slide 36: Understanding information       Mental retardation Major depression Delirium Anxiety Dementia Intoxication
Slide 37: Appreciating information  Suffering from the effects of peripheral vascular disease, a 71-year old woman was admitted to the hospital with gangrene of the three middle toes on her left foot. The residents on the surgical unit explained to her the likelihood that, without amputation of the distal part of her foot, the infection would spread, leading either to subsequent amputation of the leg or, if treatment were still withheld, to her death. She was able to recount everything she was told but refused to proceed with the surgery. When the residents, asked why, she explained that, although she thought the doctors were sincere their desire to help her, they nevertheless were mistaken about the nature of her condition. Her toes were not gangrenous, but simply dirty. If the nurse would wash her toes, which she herself couldn't reach, the would no longer be black and she could go home. Washing her toes and informing her that they were still black did not change her view of the situation; she continued to claim that it was dirt and not gangrene that was the cause of the problem.  The woman appears fully to grasp the meaning of what has been disclosed to her, but she appears not to believe that what she has been told applies to her condition.
Slide 38: Appreciating information  Does the patient:  acknowledge or appreciate that they are suffering from the disorder with which they have been diagnosed.  Acknowledge the consequences of the disorder and of potential treatment options for their own situation.  Lack of appreciation refers to people who, because of cognitive deficits or emotional states, fail to accept the relevance of their disorders or potential treatment consequences for their own circumstances.
Slide 39: Appreciating information  After fourteen prior hospitalizations for treatment of manic episodes, a 33 y.o. man was again admitted to a psychiatric hospital. Since the onset of his disorder 6 years before, he had been tried on a large number of maintenance medications, none of which had prevented recurrence of mania. After stabilization of his acute condition, his current psychiatrist, who had not treated him previously, approached him about using a new combination of medications after discharge. Each of the medications presented some risk of unpleasant side effects, but the psychiatrist was enthusiastic about their potential for reducing the frequency of recurrences of mania. Thus, she was taken aback by the patient's rejection of the proposal. “I don’t believe any of these medications are going to help,” he said. “nothing has before and I don’t see why this is going to be any different.
Slide 40: Appreciating information  Failure of appreciation:  The patient’s belief must be substantially irrational, unrealistic, or a considerable distortion of reality.  The belief must be the consequence of impaired cognition or affect.  The belief must be relevant to the patient’s treatment decision.
Slide 41: Appreciating information: Religious beliefs  Religious beliefs are neither rational or irrational.  Our society generally has placed religious beliefs beyond the purview of the courts and other administrative structures.  Freedom of religion is Constitutionally protected.  Clinically we are concerned with determining whether the patient’s stated beliefs reflect genuine religious beliefs.  Only when the well-being of minors or of other third parties is involved are the courts likely to intervene.
Slide 42: Ability to Reason  A 48 y.o. woman with a chronic mental disorder became psychotically depressed. She told her psychiatrist that she was a prostitute who deserved to be “exterminated,” and that is what they should do with her. When ECT was recommended, she declined, saying that she already had brain damage and that the procedure was likely to kill her. One of her psychiatrists challenged her decision, asking why, if she wanted to die, she would turn down a procedure that she thought was likely to cause her death. The patient could not offer a coherent response.
Slide 43: Difficulties in Reasoning  Some patients cannot deal with the complexities of the options.  Some patients’ choices seem not to follow from their stated preferences for various consequences.  Some patients may be overwhelmed by the decision-making task.  The reasoning requirement pertains to the potential irrationality in the processing of information.
Slide 44: The Reasoning Process  Problem Focus: needs to be able to stay focused on the problem of selecting a treatment.  Considering Options: needs to take into account the range of available options while processing the decision.  Considering and Imagining Consequences: needs to consider the consequences of the options.  Assessing Likelihood of Consequences: needs to be able to assess the probabilities of various outcomes.  Evaluating Consequences: needs to weight the desirability of various consequences based on one’s own subjective values.  Deliberating: needs to engage in a process of comparing and “working with” the relevant consequences, their probabilities, and desirabilities.
Slide 45: Incompetence (Grisso & Appelbaum)  Incompetence constitutes a status of the individual that is defined by functional deficits (due to mental illness, mental retardation, or other mental conditions) judged to be sufficiently great that the person currently cannot meet the demands of a specific decision-making situation, weighed in light of its potential consequences.
Slide 46: Competency and the Right To Refuse Treatment: Application of the President & Directors of Georgetown College, Inc. (1964)  Mrs. Jones was a Jehovah’s Witness & a patient at Georgetown University Hospital who needed a blood transfusion.  She refused, as did her husband and the hospital sought relief from the district court; which dismissed them.  The hospital then went to the Appeals Court. Justice Skelly Wright went to the hospital to speak with the patient and decided that she should get the transfusion.
Slide 47: Competency and the Right To Refuse Treatment: Application of the President & Directors of Georgetown College, Inc. (1964)  U.S. Court of Appeals, D.C. Circuit  The patient had come to the hospital seeking help, thus creating a responsibility (liability potential) for the hospital.  She did not want to die.  She was extremely ill & incompetent.  Allowing her to die would have deprived her seven month old child of a mother.
Slide 48: Competency & voluntary admission: Zinermon v. Burch (1990)  Darrell Burch was picked up wandering along a Florida highway. He was disoriented, hallucinating & disorganized in thought.  He was admitted to Florida State Hospital on a voluntary  He sued because he was deprived of his liberty without due process because he lacked the capacity to give informed consent to his admission.  U.S. Supreme Court held that Mr. Burch had a case.
Slide 49: Competency and the Right to Die: Cruzan v. Director (1990)  Nancy Cruzan sustained cerebral contusion in an auto accident & consequent permanent brain damage.  Progressed from coma to an unconscious state in which she was able to ingest nutrition and hydration through a gastrostomy tube. She was in a persistent vegetative state.  Nancy’s parents asked for termination of nutrition & hydration but court refused.  Missouri Supreme Court upheld this decision, and U.S. Supreme Court affirmed
Slide 50: Competency and the Right to Die: Cruzan v. Director (1990)  U.S. Supreme Court  The State Supreme Court said that there should be clear & convincing evidence that termination would have been Cruzan’s wishes.  Because Cruzan was incompetent, it was reasonable for a surrogate to make the decision.  To be sure that a surrogate reflects the wishes of the incompetent, a state has the right to establish procedural safeguards.
Slide 51: INFORMED CONSENT: THE LEGAL DOCTRINE  DISCLOSURE OF INFORMATION  OBTAIN CONSENT BEFORE ADMINISTERING TREATMENT  VOLUNTARY NATURE OF CONSENT
Slide 52: Voluntary Consent: Kaimowitz v. Michigan Department of Mental Health (1973)  Lewis Smith was committed as a criminal sexual psychopath in 1965 after he raped and murdered a student nurse. In 1972 he went to Lafayette Clinic as a research subject to compare amygdaloidotomy v. Cyproterone treatment. Smith signed a consent; his parents signed; a 3 member panel reviewed and approved the study.  Kaimowitz was an attorney for Legal Aid who read about the case in the paper and said Smith was being illegally held.  Court agreed, voided consent and said it was a violation of due process, since there was no hearing and no determination of guilt.
Slide 53: Voluntary Consent: Kaimowitz v. Michigan Department of Mental Health (1973)  Trial Court, Michigan, 1973  “involuntarily confined mental patients live in an inherently coercive institutional environment.”  It would be impossible for an involuntarily hospitalized patient to feel free of coercion when is release from the hospital might depend on his consenting to experimental psychosurgery.
Slide 54: Special issues in informed consent  Exceptions  Psychotherapy, confidentiality and duty to protect.  Managed care  Psychiatric evaluations for third parties  Minors
Slide 55: Informed consent: exceptions     1. 2. 3. 4. Emergencies Patient incompetence Therapeutic privilege Therapeutic waiver
Slide 56: Incompetence & informed consent: Superintendent of Belchertown v. Saikewicz (1977)  Saikewicz was 67, profoundly retarded with AML.  Poor chance of survival even with prolonged, painful chemotherapy.  Guardian appointed and recommended not treating.  Probate court agreed
Slide 57: Incompetence & informed consent: Superintendent of Belchertown v. Saikewicz (1977)  Case reviewed by Massachusetts Supreme Court  Even mentally incompetent persons have the right to refuse life-sustaining treatment.  Substituted judgment: what the patient would have decided if he/she were competent.
Slide 58: Informed Consent, incompetence & advanced directives  Available & authorized in all states.  Living will:  made while the patient is competent & relevant only when the patient is incompetent.  May be overridden if not specific enough.  Health care proxy (durable power of attorney)  appoints someone else to act as agent.  “durable” allows power of attorney to endure past the point of individual competence.
Slide 59: Informed Consent, incompetence: Advantages of durable power  Agent stands in the shoes of the patient.  Agent gets the patient’s power to make decisions.  Agent has the right to receive the same information that the patient would in order to arrive at a rational decision.  Patient Self Determination Act (1990): patients in facilities receiving Federal Funds must be notified of right to execute advanced directive.
Slide 60: Informed consent & minors  1. With very young patients, treat the parent as the decision maker.  2. In an emergency, render treatment.  3. Alcohol Abuse treatment may be rendered without parental consent.  4. Mental health treatment may be rendered without parental consent  5. Minors may consent to hospitalization if they are over 16, but must have authorization of some adult figure.
Slide 61: Informed consent & the emancipated minor  1. Has the contractual capacity and common law rights and responsibilities of adulthood.  2. Must willingly be living apart from parents.  3. Must demonstrate some degree of financial selfsufficiency.  4. Parents must actively consent or fail to object to the child’s departure.  5. Minors may consent to hospitalization if they are over 16, but must have authorization of some adult figure.
Slide 62: Informed consent & the mature minor  1. Necessary medical treatment, no serious hazard, for the adolescent’s benefit only.  2. 15 years old and up with the capacity to make informed judgments.  3. The adolescent must be mobile, independent, able to make decisions on daily & financial affairs.  4. Must be able to initiate treatment in his/her own behalf  5. Minors may consent to hospitalization if they are over 16, but must have authorization of some adult figure.
Slide 63: Medicolegal aspects of informed consent: Conclusion  “Life is short, art is long; opportunity is fleeting, experiment is dangerous; judgment is difficult. It is not enough for the physician to do what is necessary, the cooperation of the patient and the attendants must be secured, and circumstances must be favorable.”  Aphorisms of Hippocrates (460-400B.C.)