Health Care Law and Legislation, Statistics Policies

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Patient Consent

Chapter 12

LEARNING OBJECTIVES – I

Explain the concept of informed consent.

Discuss difference between verbal, written, & implied consent.

Describe role of the patient, physician, nurse, & hospital in informed consent.

LEARNING OBJECTIVES – II

Explain how consent differs between competent patients, minors, guardians, and incompetent patients.

Discuss under what circumstances a patient might refuse treatment.

Explain the available defenses for defendants as it relates to informed consent.

Consent

Voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself.

Informed Consent

Legal doctrine where a patient has right to know potential risks, benefits, & alternatives of a proposed procedure.

Patient has absolute right to know about & select from available treatment options.

Forms of Consent

Express consent

Verbal

Written

Implied Consent

Generally be presumed when immediate action is required to prevent death or permanent impairment of a patient’s health

e.g., treatment of accident victim

Forms of Consent - II

Statutory Consent

Many states have adopted legislation allowing for emergency care.

Judicial Consent

Allowed when there is concern as to the absence or legality of consent.

Physicians Informed Consent

Informed consent is predicated on duty of the physician to disclose sufficient info to enable patient to evaluate proposed medical or surgical procedures before submitting to them.

Physicians expected disclose risks, benefits, & alternatives of recommended procedures.

Disclosure: what a reasonable person would consider material to a decision of whether to or not to undergo treatment.

Nurses Informed Consent

Nurses most cases have no duty to

advise a patient as to a surgical procedure to be employed

may confirm physician has explained the procedure

witness patient’s signature on consent form

Hospitals Informed Consent

Not generally responsible for informing patients as to the risks, beneﬁts and alternatives.

Some cases in which hospitals have a duty

CT Scans

MRI Imaging

Patients Informed Consent

Patient's ability to:

understand risks, benefits, & alternatives

evaluate info provided by the physician

express his or her treatment preferences

voluntarily make decisions regarding his or her treatment plan

CASE: Course of Treatment Patient’s Decision

Elderly woman living alone fell & fractured her hip. An orthopedic surgeon reviewed the patient's condition & decided that rather than utilizing a pinning procedure for her hip, it would be better to adopt a conservative course of treatment, bed rest.

CASE: Course of Treatment Patient’s Decision – II

Prior to her injury, plaintiff maintained an independent style of living.

Expert testimony at trial indicated that bed rest was an inappropriate treatment.

Was the patient successful for not being informed as to alternatives courses of treatment?

CASE: Court’s Decision

Court held that it is necessary to advise a patient when considering alternative courses of treatment. The physician should have explained medically reasonable invasive & noninvasive alternatives, including risks & likely outcomes of those alternatives, even when the chosen course is noninvasive.

−Matthies v. Mastromonaco

CASE: Lack of Consent

Patient had multiple medical diagnoses. Her physician, Dr. Sottiurai, ordered bilateral arteriograms to determine cause of the patient's impaired circulation. De La Ronde Hospital could not accommodate Sottiurai's request & patient was transferred to Dr. Lang, a radiologist at St. Jude Hospital.

CASE: Lack of Consent – II

Lang performed a femoral arteriogram, not the bilateral brachial arteriogram ordered by Sottiurai. The patient was prepared for transfer back to De La Ronde Hospital. Shortly after the ambulance departed, patient suffered a seizure in the ambulance & was returned to St. Jude. Riser's condition deteriorated & died 11 days later.

What did the trial court determine?

CAST: Trial Court Decision

The district court ruled for the plaintiffs, awarding damages in the amount of $50,000 for Riser's pain and suffering and $100,000 to each child. Lang appealed.

On appeal, what did the appeals court determine?

CASE: Appeals Court’s Decision

The Court of Appeal held that Lang breached the standard of care by subjecting the patient to a procedure that would have no practical benefit to the patient, that Lang failed to obtain informed consent from the patient.

−Riser v. American Medican Intern, Inc.

Information to be Disclosed

Physician should provide as much information about treatment options as necessary based on a patient's personal understanding of physician's explanation of risks of treatment & probable consequences of treatment.

Needs of each patient can vary depending on age, maturity, & mental status.

Information to be Disclosed – II

Individual responsible for obtaining consent must weigh importance of giving full disclosure to the patient against likelihood such disclosure will adversely affect the patient’s decision.

Information to be Disclosed – III

Courts generally utilize an "objective" or "subjective" test

to determine if a patient would have refused treatment if the physician had provided adequate information

as to the risks, benefits, & alternatives of the procedure.

Subjective test

Relies on credibility of the patient’s testimony

Patients must testify & prove they would not have consented to the procedure(s) had they been advised of the risks.

Objective Test

Take into account characteristics of the plaintiff

idiosyncrasies, fears, age, medical condition, and religious belief

Must show that a “reasonable person” would not have undergone a procedure if properly informed.

Assessing Decision-Making Capacity

Patient understands risks, benefits, & alternatives of a proposed test or procedure

Patient evaluates the information provided by the physician.

Patient expresses his/her treatment preferences

Patient Voluntarily makes decisions regarding his or her treatment plan without undue influence (e.g., family, medical personnel)

Adequacy of Consent

Patient:

understand risks, beneﬁts, & alternatives

evaluates the information provided

expresses treatment preferences

voluntarily makes decisions regarding treatment plan

Verbal Consent

As binding as written consent.

More difficult to corroborate.

Written Consent Describes

Nature of the patient’s illness

Procedure consented to

Risks & probable consequences of the procedure

Probability that the proposed procedure will be successful

Written Consent Describes – II

Alternative methods of treatment

Associated risks & benefits of each

Indication the patient understands nature of proposed treatment

Signatures dated & signed

patient

physician

witnesses

Special Forms of Consent

Admission Consent

Consent for Routine Procedures

Consent for Specific Procedures

Implied Consent

Statutory Consent

Judicial Consent

Statutory Consent

Consent generally assumed

Ambulance Care

Good Samaritan Statutes

Emergency Departments

When patient clinically unable to give consent

Judicial Consent

May be periodically necessary

When alternatives exhausted

2nd opinions by consulting physicians helpful

On-call legal advice should be sought

Who May Consent

Competent patients

Guardianship

Parental Consent

Emancipated Minor

INCOMPETENT PATIENTS

Ability to consent to treatment is a question of fact.

When a physician doubts a patient’s capacity to consent, even though the patient has not been judged legally incompetent, the consent of the nearest relative should be obtained.

LIMITED POWER OF ATTORNEY

Parental authority to have, for example, school officials & camp counselors to act on a parents’ or legal guardian’s behalf when seeking emergency care.

Such consent for treatment provides limited protection in the care of a particular child.

Refusal of Treatment

For any or no reason

Mere whim

Refusal of Treatment: Religious Beliefs

Blood or blood products

Impatience

Text Case: Good People Bad Decisions

Discharge Against Medical Advice

Completed release provides documented evidence of a patient's refusal to consent to a recommended treatment.

Refusal to consent to treatment.

Release form should be executed.

Discharge/Leaving Against Medical Advice

Note if patient refuses to sign release.

When in Doubt

Error on the Side of Life

Informed Consent Defenses

Risk not disclosed is commonly known.

Patent did not want to know about the risks.

Consent not reasonably possible.

Physician disclosed what he considerable reasonable

Ethics Informed Consent

Individual Autonomy

Informed consent protects the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he or she knowledgeably consents.

Consent forms should be used as a supplement to the oral disclosure of risks, benefits, and alternatives to the proposed procedure that a physician normally gives.

REVIEW QUESTIONS – I

1. Who should be responsible for reviewing with the patient the risks, benefits, and alternatives of a proposed diagnostic test or treatment?

2. Describe what information a patient should be provided prior to undergoing a risky procedure in order for consent to be informed.

3. Why is it important to obtain consent from a patient prior to proceeding with a risky procedure?

REVIEW QUESTIONS – II

4. Can a patient consent to a procedure and then withdraw it?

5. Can a parent refuse to consent to a lifesaving procedure for his or her child? Discuss your answer.

6. Discuss how much information is sufficient in order for informed consent to be effective (e.g., consider your answer here from both the objective and subjective forms of consent).

REVIEW QUESTIONS – III

7. Discuss the implications of the following statement: "Patients are generally persons unlearned in the medical sciences and, therefore, except in rare instances, the knowledge of patient and physician is not in parity."