Chapter 6: Rights, Truth and Consent

Section 4. Readings The Origins of Informed Consent

The Origins of Informed Consent
 

1. Currently, the doctrine involves a strong judicial deference to personal autonomy

2. The notion is that a person should be free from non-consensual interference with his or her person and should not be made to do something against their will.

3. The current philosophy was articulated by Judge Cardozo in Scholendorf vs. Society of new York Hospital:  Every human being of adult years and sound mind has a right to determine what shall be done with his own body….”

4. The doctrine arguably serves several purposes:

1. Protects individual autonomy

2. Protects the patient’s status as a human being

3. Avoids fraud and duress

4. Encourages doctors to carefully consider their decisions

5. Fosters rational decision making by the patient.

6. Involves the public generally in medicine.

5. Development of the doctrine falls into roughly three periods

1. Until the mid-twentieth century – based on the law of battery with little more disclosure required than what procedure was being proposed.

2. A period of emerging belief that the procedures, risks, alternative procedures and their risks should be disclosed.

3. The current period since the early 1970’s of legislative entrenchment and judicial inertia, meaning nothing is happening beyond the common law development of the prior period.

2. The Legal Framework

1. Battery

1. Focuses on a touching other than that which for which consent was obtained.

2. There is no need of expert testimony.  There is no standard of care as in the law of negligence.

3. The only proof required is that the touching was different then that for which consent was obtained.

2. Negligent Non-Disclosure

1. Focuses on the physician’s duty to inform

2. The specific issue is what should the physician told the patient.  This is typically established through expert medical testimony.

3. The proof is whether a reasonable person in the patient’s position would have consented to the treatment or procedure had the proper information been disclosed.

3. Negligence as the Basis for Recovery – Canterbury vs. Spence

1. Two Standards Described by the Court

1. Professional Custom Rule – What is the custom of physicians in the locality in disclosing information to the patient.

2. Patient Oriented Rule – Was sufficient information disclosed so that the reasonable patient can make and informed decision.

2. The Court in Canterbury rejected that professional custom rule because (i) what is perceived to be custom may be no custom at all, (ii) the physician deciding what to disclose is contrary to concepts of patient autonomy and (iii) the rule is self-serving.

3. The court test:  A risk should be disclosed if it is material, and it is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or the cluster of risks in deciding whether or not to forego the proposed therapy.

4. Problems with this approach

1. Who measures what is a reasonable patient?

2. Are we not placing the judgment of the physician back into the equation at the expense of the patient?

4. Disclosure of Physician  Specific Information – Johnson vs. Kokemoor

1. The question is whether a physician must disclose  information specific to his or her experience

2. In this case, the court, noting the specific facts and circumstances, held that a reasonable person in the patient’s position should be told bout these issues in order to make and informed decision concerning whether to have the proffered treatment.

5. Disclosure of Statistical Mortality Information – Arato vs. Avedon

1. Plaintiffs claimed that specific statistical survival information should have been disclosed so that decedent could have made an informed decision on chemo and radiation therapy.

2. Inference is that the patient would have made a choice of foregoing the rigors of essentially experimental therapy when it would probably have done little good.

3. A claim was also made that lack of financial information caused personal financial loss which could have been avoided.

4. Court agreed that on the issue of the medical impact of failure to provide informed consent, but said personal financial consequences were not a part of the doctrine and there could be no recovery.

6. Disclosure of Risks of Non-Treatment – Truman vs. Thomas

1. Facts:  Physician allegedly failed to inform a patient of the material risks of not consenting to a recommended pap smear, so patient was unable to make an informed choice, resulting in the patient’s death form cervical cancer.

2. The court found against the physician for failing to provide that information.

3. The physician argued the patient should have taken the initiative to ask.

4. Issues raised by the decision.

1. How far do the “fiducial duties” of the physician extend in providing information to the patient?

2. How aggressive should the physician be in insisting that the test be obtained?

3. Where does the physician’s responsibility end and the patient’s begin?

4. What is the role of the element of cost, if any?

7. Disclosure of Physician Conflicts of Interest – Moore vs. Regents of the University of California

1. Patient tissue, fluids, etc. were collected over time and utilized to do research and ultimately to formulate a product which was patented for which defendants received significant payment, all without any knowledge of the patient.

2. The patient when he found out sued for breach of a physician’s fiduciary duty and lack of informed consent.

3. Court found that the appropriate physician duties had been breached, but found no recovery for conversion of property.

8. Causation Complexities – Canterbury vs. Spence

1. Issue:  There must be a causal connection between the failure to disclose information and the damage to the patient.

2. The court stated the rule to be that a causal connection exists when, but only when, disclosure of significant risks incidental to treatment would have resulted in a decision against the procedure.

3. The standard:  What a prudent person in the patient’s position would have decided if suitably informed of all perils bearing significance.

1. What is significant?—what percentage of risk should be involved?

2. What is the role of the patient’s testimony since it will be retrospective in time?

9. Exceptions to the Duty to Disclose – Canterbury vs. Spence

1. Consent is implied when a patient unconscious or otherwise unable to consent and harm of failure to treat outweighs harm of proposed treatment.

2. Therapeutic Privilege is used when the risk of disclosure poses such a threat of detriment to the patient as to become unfeasible or contraindicated from a medical point of view.

7. Consent Forms and The Hospital

5. Informed consent is generally the responsibility of the treating physician.

6. Hospitals generally obtain consents for routine admitting tests and other activity.

7. The consent form is usually evidence of consent, not a conclusive contract or statement.  It can be attacked by the patient.

8. The essence of informed consent is the communication between the physician and patient.  The form simply memorializes that something occurred.

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© Copyright Philip A. Pecorino 2002. All Rights reserved.

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