The document discusses the principles of informed consent and a physician's duty to disclose all relevant medical information to patients. It notes that disclosure should be tailored to meet individual patient preferences and needs. A physician must consider factors like a patient's diagnosis, prognosis, treatment options and risks when obtaining informed consent. The scope of disclosure depends on how severe the proposed treatment is and its risks and benefits. The document emphasizes open communication between physicians and patients in the informed consent process.

1. 
Informed
Consent
Bernard W. Freedman, JD, MPH
Santa Monica, CA
bwfreedman@netscape.net

2. 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."

3. The American Medical Association
Section 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.

4. 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.

5. 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.

6. 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.


7. 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.

8. 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.

9. 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.

10. 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.

11. 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

12. Staying on theVentilator
12% 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

13. 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

14. Jose Ortega y Gasset
Law is born from despair of human nature.

15. 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.”

16. 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.

17. 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

18. 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.

19. 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.

20. Withholding Life Sustaining Treatment
Terminal Non Terminal
PVS
Yes Yes
Yes - ? Clear & Convincing
Evidence of Consent
Minimal
(or greater)
Conscious
State

21. 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).

22. 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.

23. 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.

25. 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

26. 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

27. 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.

28. 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.

29. 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

30. 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.

31. 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.

32. 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

33. Excessive - Aggressive Care
In 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.

34. 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

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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

42. Do not hide behind the surrogate
You are not treating the surrogate.
Dealing with a surrogate does not mean abandoning your
patient.

43. 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.

44. 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.

45. 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.

46. 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.

47. 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.