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Medical Jurisprudence Behavioral Sciences Term St. Georges University School of Medicine Visiting Professor Thaddeus Pope, JD, PhD

Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

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Page 1: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Medical Jurisprudence

Behavioral Sciences Term St. Georges University School of Medicine

Visiting Professor Thaddeus Pope, JD, PhD

Page 2: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Segment 2 of 8

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Informed Consent

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Objectives

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1. What is the history of informed consent?

2. What is medical battery? 3. What is the difference

between battery and informed consent?

Page 6: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

4. What are the elements of an informed consent cause of action?

5. What are the two U.S. standards for measuring a physician’s duty of disclosure?

Page 7: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

6. What are the 6 exceptions to this duty?

7. What does the causation element require?

8. What is SDM and patient decision aids

Page 8: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

History

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Do NOT consider patient’s “own crude opinions”

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Battery

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No consent at all

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Mohr v. Williams (Minn. 1905)

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“Every human being of adult years and sound mind has a right to determine what shall be done with his own body . . . . ”

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Consent But not “informed”

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Salgo v. Leland Stanford (Cal.)

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Natanson v. Kline (Kan.)

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Jerry Canterbury

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Battery

Page 34: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

No consent at all

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4 variations

Page 36: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

(1) No consent to any procedure

Page 37: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Richard Dreyfus

Page 38: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

(2) Consent only to different procedure

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Seaton v.

Patterson

(Ky. App. 2012)

Page 41: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University
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(3) Same procedure, different body part

Page 44: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

(4) Same procedure, same part, different doc

Page 45: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University
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Comparing battery & informed consent

Page 47: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Battery is far simpler

Page 48: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Informed Consent

Battery

Injury X Duty X Exceptions X Conduct causation X Experts re risks (or duty –IN,DE)

X

Punitive damages X

Page 49: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

PTF need not be injured (can even be benefitted)

(harm is to dignity, not body)

Page 50: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Battery

PTF: “I did not consent”

Page 51: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Informed consent

PTF: “I did consent . . . ”

Page 52: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

“BUT I would not have consented, if disclosure had been appropriate [non-negligent]”

Page 53: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Comparing malpractice & informed consent

Page 54: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

3 theories of medical malpractice Abandonment Informed consent Deviation SOC

Page 55: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

But deviation from SOC is also referred to “malpractice”

Page 56: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

3 theories of medical malpractice Abandonment Informed consent Malpractice

Page 57: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Physician may have performed the right procedure perfectly

Page 58: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Problem is physician did not make appropriate disclosures

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Informed Consent

(Elements)

Page 61: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Duty What to disclose

Breach Did not disclose

Injury Undisclosed risk happened

Causation With disclosure, would have avoided injury

Page 62: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Duty

Page 63: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Core complaint:

Physician failed to disclose information

Page 64: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

But legally actionable only if physician had a duty to disclose that information

Page 65: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Types of information to disclose

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Inherent risks from proposed treatment

Probability

Severity

Page 68: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Alternatives

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Benefits & risks of each alternative

One alternative is doing nothing

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Who will be providing treatment

Including: role of: residents, fellows, students, and others

Page 72: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Physician experience

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Doc Said Best in world

Literature Limited experience

2% 11% 15% 30%

Johnson v. Kokemoor

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Conflicts of interest

Disclose intent in using patient for research and economic gain

Page 78: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Doc does not have a duty to disclose all of this

Page 79: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

What to disclose?

Not everything

Can’t send patient to med school

Page 80: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Risks alternatives

DUTY identifies the subset of risks & alternatives to disclose

Page 81: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

2 main ways to measure MD duty

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Reasonable MD 20+ states

Reasonable PT 20+ states

Page 83: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Which standard applies depends on which state you are in

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Reasonable Patient Standard

Page 85: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

aka “material risk” standard

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Duty measured by patient needs

Page 87: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Duty to disclose what would a reasonable patient consider important / significant in making this treatment decision

Page 88: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Odd No duty

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Canterbury v.

Spence

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Right procedure

Performed competently

Page 93: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

1% risk paralysis

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Reasonable prudent patient would want to know that risk

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Therefore, physician has duty to disclose it

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Duty measured by what hypothetical reasonable patient would deem material, significant in making treatment decision

Page 97: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

But a hypothetical reasonable patient in this patient’s circumstances

Page 98: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

“Frozen shoulder”

Wilson v Merritt

Page 99: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Reasonable Physician Standard

Page 100: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

aka “professional standard” aka “malpractice standard”

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Duty is measured by professional custom

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Duty to disclose what would the reasonable physician have disclosed under the circumstances

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Risks, alternatives DEF has duty to disclose

Are those reasonable physician would disclose under circumstances

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Custom to not disclose

No duty

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How do we know what a reasonable physician would disclose

Expert witnesses

Page 106: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

Almost always, PTF needs expert witness to establish the standard of care

Page 107: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

No expert no SOC

No SOC no breach

No breach no case

Page 108: Medical Jurisprudence - Thaddeus Mason Popethaddeuspope.com/images/POPE_3_of_9_-_Informed_Consent.pdf · Medical Jurisprudence . Behavioral Sciences Term . St. Georges University

In any given state, duty is established in just one way

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Exceptions to duty

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Even if prima facie duty under reasonable patient or reasonable physician standard, no duty if any 1 of 6 exceptions applies

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Information already known

To this particular patient

Or commonly known

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Emergency

Urgent immediate need

Patient lacks capacity

No opportunity for consent from surrogate

No known objection

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Therapeutic privilege

Disclosing risk information would make the patient so upset: That could not make a rational choice

That would materially affect medical condition

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Waiver

Patient does not want to know (defers to physician)

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Public Health

Must treat to protect the community (e.g. infectious disease)

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CBO clause

Clinicians can sometimes avoid duty for moral/religious reasons

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Breach

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DEF actually failed to disclose what she had a duty to disclose

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PTF must actually be injured from undisclosed risk

(no dignitary tort)

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“I could have been . . . .”

No injury No informed consent claim

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Causation

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Breach

Injury

Causation

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Hypothetical question

Objective standard

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But for DEF breach (i.e. lack of disclosure), PTF would not be injured

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3 sub-elements

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1. PTF would have chosen differently

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Had disclosure been made, this patient (PTF) would not have consented

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2. Reasonable patient would have chosen differently

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Had disclosure been made, a reasonable person in the patient’s circumstances would not have consented

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Sub-elements 1 & 2 establish the premise of this equation

No consent = no procedure

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3. Different choice would have avoided injury

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Sub-element 3 establishes this equation

No procedure = no injury

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The materialized risk must have been caused (etiologically) by the intervention

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If knew 1% risk, would have decided against procedure

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No procedure no paralysis

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If paralysis from procedure (as opposed to underlying illness)

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Diachronic Aspect to

Duty

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Not a one-time

ongoing duty

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Sufficient disclosure

New clinical circumstances change risks

Must update disclosure

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Cesarean

Contractions – VB now option

Must update disclosure Kohoutek v. Hafner

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Cesarean v.

No baby

Cesarean v.

VB (but big baby)

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Gastrectomy

Liver function

Must update disclosure Cornfeldt v. Tongen

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Reasonable patient states: duty disclose new information IF reasonable patient would find material

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Reasonable physician states: duty disclose new information IF professional custom to disclose that

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PTF claims doc failed to disclose

Would info be material (sig factor) to reasonable person’s decision?

Material risk jurisdiction?

Y

No duty

Exception apply?

N

Y

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Exception apply?

Y No duty - action fails

N

Duty to disclose

Failure to disclose = breach

Check for causation & damages

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Thaddeus Mason Pope Director, Health Law Institute Hamline University School of Law 1536 Hewitt Avenue Saint Paul, Minnesota 55104 T 651-523-2519 F 901-202-7549 E [email protected] W www.thaddeuspope.com B medicalfutility.blogspot.com