Explain the concept of informed consent.

Chapter 13

Patient Consent

LEARNING OBJECTIVES – I

Explain the concept of informed consent.
Discuss the difference between verbal, written, and implied consent.
Describe the role of the patient, physician, nurse, and 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.

Forms of Consent

Express consent
Verbal
Written
Implied consent
Act or silence raising presumption consent has been authorized
e.g., treatment of accident victim

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.

Physicians
Informed Consent

Informed consent is predicated on the duty of the physician to disclose sufficient info to enable the 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

Course of Treatment
Patient’s Decision – I

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.

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?

Yes!
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

Lack of Consent – I

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.

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?

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?

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 – I

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.

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.

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.

Adequacy of Consent

Patient understand risks, beneﬁts, & alternatives
Evaluate the information provided
Express treatment preferences
voluntarily make decisions regarding treatment plan

Written Consent Describes – I

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

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
Consent for minors
Incompetent patients
Limited Power of Attorney

Right to Refuse Treatment

For any or no reason
Mere whim
Religious Beliefs
Blood or blood products
Impatience
Text Case: Good People Bad Decisions

Release Form

Completed release provides documented evidence of a patient’s refusal to consent to a recommended treatment.
Patient’s refusal to consent to treatment, for any reason, religious or otherwise, should be noted in the medical record.
A release form should be executed.

Informed Consent Defenses

Risk not disclosed is commonly known.
Patient assured practitioner he would undergo treatment regardless of the risk.
Consent not reasonably possible.
Patent did not want to know about the risks.
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.

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.”

Explain the concept of informed consent.

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