InformedConsent

Bernard W. Freedman, JD, MPHSanta Monica, CAbwfreedman@netscape.net

Maimonides: (1135 - 1204) The Duty of a Physician

"It is the duty of the physician to regard the patient not as a specimen to be placed in a particular class but as an individual, to consider his constitution, his emotional state, habits, physical strength, the immediate conditions, etc., and to avoid routine treatment."

The American Medical AssociationSection 808 - Code of Medical Ethics

Physicians should sensitively and respectfully disclose all relevant medical information to patients. The quantity and specificity of this information should be tailored to meet the preferences and needs of individual patients.

Substantive Due Process and Fundamental Rights

“In recognition of the dignity and privacy an adult has:

Every person has a fundamental right to control their life, their privacy, including decisions relating to his or her own health care.

This right cannot be effectuated without disclosure to the patient of all information in an intelligent, thoughtful and respectful fashion.

The rule to follow is:

Disclosure, then Consent.

The Captain of the Ship – California Probate Code 4631

"Primary physician" means a physician designated by a patient or the patient's agent, conservator, or surrogate, to have primary responsibility for the patient's health care or, in the absence of designation or if the designated physician is not reasonably available or declines to act as primary physician, a physician who undertakes the responsibility.

California Probate Code 4609

4609. "Capacity" means a person's ability to understand the nature and consequences of a decision and to make and communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks, and alternatives.

California Probate Code 4732

4732. A primary physician who makes or is informed of a determination that a patient lacks or has recovered capacity, …, shall promptly record the determination in the patient's health care record and communicate the determination to the patient, if possible, and to a person then authorized to make healthcare decisions for the patient.

California Probate Code 4658

Unless otherwise specified in a written advance health care directive,a determination that a patient lacks or has recovered capacity, or that another condition exists that affects an individual health care instruction or the authority of an agent or surrogate, shall be made by the primary physician.

Right to Decline to Treat Probate Code 4735

A health care provider or health care institution may decline to comply with an individual health care instruction or health care decision that requires medically ineffective health care or health care contrary to generally accepted health care standards applicable to the health care provider or institution.

California Probate Code 4714

A surrogate, shall make a health care decision in accordance with the patient's individual health care instructions, if any, and other wishes to the extent known to the surrogate…

In determining the patient's best interest, the surrogate shall consider the patient's personal values to the extent known to the surrogate.

Note: If the surrogate cannot do so, have them replaced.

Communication is lacking – CPR/DNRs

In a prospective cohort study in five tertiary medical centers found that:

<23% physicians discussed CPR preferences with seriously ill patients

(n1589)

Annals of Internal Medicine: (1997) 127:1; 1-12

Staying on the Ventilator12% discussed preferences with their physicians

20% said that they wanted it

80% said that they did not want it. (n 1573)

Annals of Internal Medicine 1 July 1997 | Volume 127 Issue 1

Patient’s perspective

…once pain rouses us, there is no one but ourselves, alone with our disease, with the thousand thoughts it provokes in us and against us.

E. M. Cioran

Jose Ortega y Gasset

Law is born from despair of human nature.

Bouvia v Superior Court

“If the right exists, it matters not what motivates its exercise. We find nothing in the law to suggest the right to refuse medical treatment may be exercised only if the patient’s motives meet someone else’s approval.”

The California Supreme Court - Cobbs v. Grant

The patient's right of self-decision is the measure of the physician's duty to reveal.

The scope of the physician's disclosure is measured by the patient's need.

The California Supreme Court - Cobbs v. Grant

1. A mini-course in medical science is not required;

2. There is no physician's duty to discuss the relatively minor risks inherent in common procedures

The California Supreme Court - Cobbs v. Grant

The California Supreme Court held:

A medical doctor, being the expert, appreciates the risks inherent in the procedure he is prescribing,

But once this information has been disclosed, that aspect of the doctor's expert function has been performed.

The weighing of these risks against the individual subjective fears and hopes of the patient is not an expert skill.

Such evaluation and decision is a nonmedical judgment

reserved to the patient alone.

Disclosing the Magnitude of the Risk

The degree of disclosure

Turns on the magnitude of the risk.

The greater the risk,

The greater the required disclosure.

Withholding Life Sustaining Treatment

Terminal Non Terminal

PVS Yes Yes

Yes - ?

Clear & ConvincingEvidence of ConsentMinimal

(or greater) ConsciousState

State Interest in Preserving Life/ Fundamental Right of Privacy

“We think the State’s interest weakens and the individual’s right of privacy grows as the degree of bodily invasion increases and the prognosis dims.”

The case of Karen Quinlan; Supreme Court of New Jersey (1976).

Withholding Information

700 physicians were asked how often they withheld medical information from their patient because of health plan rules.

23% said sometimes;

8% said often or very often.

These physicians betrayed and abandoned their patient putting the interest of the HMO or Health Plan as paramount.

Alternative Methods of Treatment

Patients have a right to know about other respected approaches to treatment so that they have the necessary information to base their decisions upon.

When the evidence is lacking regarding the effectiveness of a modality of treatment, it may be prudent to review what experimental protocols are being conducted.

Preparing for Informed Consent Foster understanding at onset of disease.

What are known (Statistics) what isn’t. Negotiate the content of the discussion. Pt wants to know; Does not want to know; Not sure.Everything does not have to be discussed at one sitting. Discuss positive and negative expectations

The typical disease trajectories identified in patients with different diseases.

Murtagh F E M et al. Nephrol. Dial. Transplant. 2008;23:3746-3748

© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Consent Process

Doctor Patient Relationship is a Fiduciary Relationship

Patients goals of medical care are a product of their:1. cultural background, 2. religious views, 3. personal experiences, 4. prejudices,5. biases, 6. feelings of responsibility or guilt, and 7. socioeconomic realities.

Capacity to Understand

In order to do so the patient must be able to: Understand Deliberate, and Communicate.

Ask what pt understands; what will he or she discuss with family?Refer back to this conversation later, to remind, review, and ensure ongoing understanding.

I need to have a discussion with you about the risks…

“Whatever you think, Doctor.”

1. Find someone else (surrogate speaks for patient)

2. If serious, take it to the Ethics Committee

Patient’s Refusal to Listen

Surrogates and the Therapeutic Privilege

Physicians may decide that telling a patient the truth about their illness is not in the patient’s best interest.

This does not, however, apply to a surrogate decision maker.

If a surrogate cannot fully and intelligently participate, then he or she cannot be the surrogate. Then a second surrogate must be identified, if possible. If not turn to a best interest standard.

Risk of Refusing Treatment

1. Equally important is a disclosure of the risks of not receiving the treatment being recommended.

2. This is especially important in dealing with a patient who demands to be discharged against medical advice.

3. Please document that before the patient leaves the hospital the ramifications of non-treatment have been fully explained.

4.

Excessive - Aggressive Care

Physicians may tend to overuse technologically aggressive, life-prolonging treatments and, underuse communication skills that can assist patients in making choices.

Miettinen T, Tilvis RS. Medical futility as a cause of suffering of dying patients: the family members’ perspective. J Palliat Care. 1999;15:26-29

Excessive - Aggressive CareIn a study of 164 patients with advanced dementia

and metastatic cancer admitted to a tertiary care teaching hospital, it was found that:47% received aggressive non-palliative treatments, 24% received attempted cardiopulmonary resuscitation.

Ahronheim JC, Morrison RS, Baskin SA, et al. Treatment of the dying in the acute care hospital. Arch Intern Med. 1996;156:2094-2100.

What Must Disclosure Include ?

1. Diagnosis, prognosis

2. Burdens of Illness

3. Effectiveness of Treatment v Acceptable Risk

4. Potential of rehabilitation,

5. Diminished quality of life.

6. Right to refuse treatment, and

7. Right to request palliative care/comfort care

The Gann Act - Blood Safety Act

Paul Gann was a conservative political activist. Gann died in 1989 due to complications of AIDS which he had contracted from a blood transfusion.

Gann supported legislation which led to the Blood Safety Act, now set forth in Section 1645(b)) in the California Health and Safety Code, mandating that physicians discuss the risks of blood transfusion with their patients.

 

Blood Safety Act

1. 1645(b). Requires that the patient's physician document on the patient's medical record that the patient was informed of his/her transfusion options.

2. When no life-threatening emergency and no other medical contraindications, the physician and surgeon or doctor of podiatric medicine shall allow adequate time for predonation to occur.

Blood Safety Act

However, if a patient waives the right to allow adequate time prior to the procedure for predonation to occur, a physician… shall not incur any liability for his or her failure to allow adequate time prior to the procedure for predonation to occur.

Daisy Ashcraft v. John King, M.D.

In 1983, plaintiff Daisy Ashcraft, age 16, was diagnosed as having scoliosis, which was predicted to become debilitating if not corrected. Ms. Ashcraft was referred to defendant John D. King, M.D., an orthopedic surgeon.. Plaintiff's mother testified she insisted the operation be performed using only family-donated blood.

Ashcraft v. King

Daisy’s mother and father and several other relatives gave blood before and during the operation.

None of this blood, however, ever went to Daisy Ashcraft. Instead, all of the blood Daisy received during the operation came from the general supplies on hand at Children's Hospital.

Ashcraft v. King

At the time of this surgery, in 1983, no test was available to determine whether blood was contaminated with HIV.

In 1987 the hospital discovered Daisy Ashcraft had been transfused during surgery with blood from an HIV positive donor. Daisy was contacted to come in to the hospital immediately for a blood test.

The test was positive.

Ashcraft v. King

Conditional Consent

“A Patient Has the Right to Impose Express Limitations or Conditions on a Doctor's Authority to Perform an Operation.

A Doctor Is Subject to Liability for Battery for Exceeding the Conditions Imposed by the Patient.”

Ashcraft v. King (1991) 228 Cal. App. 3d 604

Do not hide behind the surrogate

You are not treating the surrogate.

Dealing with a surrogate does not mean abandoning your patient.

Family Demands Surgery

1. The patient, a 98 year old man suffering from a dissecting aortic aneurysm of 7.5 cm. He is unresponsive and near death.

2. He previously, and with unquestioned capacity, executed an advance health directive indicating that he would refuse surgery.

3. He also had told his physician that he would rather die than to face the probable mental and physical damage and quality of life deterioration that would accompany such damage. 

4. Yet, family is insistent on surgery.

Refusal

The hospital’s anesthesiologists refused to participate in the surgery, stating that such an operation had never been performed on someone his age and in his condition, and also noted that patient had refused the surgery.

Decision to go Forward with out Consent

1. The patient’s verbal instructions were to not do the surgery.

2. The patient clearly knew the risks of the surgery. He knew of the high risk of respiratory failure, renal failure and brain damage.

3. He declined to undertake these risks and refused treatment.

The Patient

The patient was Dr. Michael DeBakey, internationally renowned surgical pioneer, who died on July 11, 2008, two months shy of his 100th birthday.

Documentation and Transparency

Unambiguous documentation of the degree of details commensurate with the degree of risk.

1. History of discussion with patient or surrogate;

2. Nursing Notes regarding information and discussions with Patient

3. Document patient’s specific questions or concerns;

4. State your Conclusion

Only by being forthright about these factors can real transparency exist.