49
7/23/2019 Electroconvulsive Treatment, Malpractice and Informed Consent http://slidepdf.com/reader/full/electroconvulsive-treatment-malpractice-and-informed-consent 1/49 Citation: 15 J. Psychiatry & L. 7 1987 Content downloaded/printed from HeinOnline (http://heinonline.org) Mon Sep 28 22:12:35 2015 -- Your use of this HeinOnline PDF indicates your acceptance  of HeinOnline's Terms and Conditions of the license  agreement available at http://heinonline.org/HOL/License -- The search text of this PDF is generated from uncorrected OCR text. -- To obtain permission to use this article beyond the scope  of your HeinOnline license, please use:  https://www.copyright.com/ccc/basicSearch.do? &operation=go&searchType=0 &lastSearch=simple&all=on&titleOrStdNo=0093-1853

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Citation: 15 J. Psychiatry & L. 7 1987

Content downloaded/printed from

HeinOnline (http://heinonline.org)

Mon Sep 28 22:12:35 2015

-- Your use of this HeinOnline PDF indicates your acceptance

  of HeinOnline's Terms and Conditions of the license

  agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from

uncorrected OCR text.

-- To obtain permission to use this article beyond the scope

  of your HeinOnline license, please use:

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&operation=go&searchType=0

&lastSearch=simple&all=on&titleOrStdNo=0093-1853

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The ournal of

Psychiatry Law Spring

1987

Electroconvulsive

therapy

malpractice

and informed

consent

BY

SHEILA

TAUB

J.D.

The

author

presents an overview o

the

use

o

electroconvulsive

therapy

in

treating

mental

illness, of current

researchinto

ECT s

safety

and effectiveness, and

o the legal treatment

o

ECT

in

malpractice

and patients

rights litigation.

She

concludes that

ECT

may be overregulated

because the law has

not

kept pace

with

changes

in

knowledge

and

procedures

concerning

ECT

with

the result thatsome

patients

who

might benefit

from

ECT

may

be

deprived

o

a

relatively

safe and effective

form

o

treatment.

Introduction

The movement

to

protect

mental patients

from coerced

and

abusive

treatment

has

led

courts, legislatures,

and even

the

public

to impose numerous

restrictions on

the use of electro-

convulsive

therapy

more

commonly referred

to as

electro-

shock therapy

or shock

therapy,

hereinafter

ECT). This

article

will

review

the

use

of E T in treating

mental illness,

recent scientific

data concerning its

safety and

effectiveness,

and

its legal

regulation via

civil suits

for

malpractice

and

 

987 by Federal

Legal Publications,

Inc.

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8

ECT

statutes

bearing

on

consent

to

treatment.

The

author

suggests

that

regulations

intended

to

protect

patients

may

be

depriv-

ing

some

of

a relatively

safe

and

highly

effective

form

of

therapy.

  istory

of

T

The

idea

of using

ECT

to

treat

mental

illness

derived

from

the

observation,

in

the

early

1900s,

that

epilepsy

and

schizo-

phrenia

appeared

to

be

mutually

exclusive.'

Seizures

were

first

induced

as

an

attempt

to treat

psychiatric

disorders

during

the 1930s,

at

first

by

chemical

means,

2

and

later

by

means

of

an

electric

current.

ECT

was

used

to treat

a

wide

variety

of

mental

illnesses,

and

soon

became

the

dominant

therapy

for

schizophrenia,

for

which

no

other

treatment

was

then

available.

By

the

late

1940s,

however,

ECT

was recog-

nized

to

be

much

more

effective

in

treating

depression.

Many

patients

received

ECT

following

World

War

II, but

its

use

gradually

declined,

mainly

due

to

the

discovery

of

effective

psychotropic

drugs

in

the

1950s.

4

Increased

state

regulation

may

have

contributed

to

its

further

decline

in the

1970s

and

8 s

Today,

relatively

few

psychiatrists

use

ECT

some

only

as

a last

resort

for patients

who

fail

to

respond

to

other

forms

of

treatment.

6

Estimates

of

the

number

of patients

who

receive

ECT

annually

in

the

United

States

today

range

from

33,000

o

between

60,000

and 100,000.1

The

frequency

of

ECT

usage

in

different

institutions

varies

widely,

from

zero

in

many

institu-

tions

to as

much

as

20

of patients

in

others.

9

This

variabil-

ity

in

the use

of ECT,

and

its relatively

infrequent

use

in

general,

may

also

be due

to physicians

and

patients

negative

attitudes

toward

ECT,

the complexity

and

expense

involved

in

the

procedure,

the

lack

of

ECT

training

for

psychiatric

residents,

and

the

lack

of

appropriate

treatment

facilities.

10

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Although

some

opponents

of ECT

claim

that

it is

used

most

often

on

the most powerless

members

of

society,

such as

criminals,

women,

and

the poor,

the

facts

do

not

support

this

contention.

Mentally

ill

criminal

offenders

are rarely

given

ECT; they

are

usually

treated

with

psychotropic

drugs.

If

ECT

is

in

fact used

more

on

women,

it may

be

because

women

have

a higher

incidence

of

depression

and manic-

depressive

disorders

(the

disorders

for which

ECT

has

been

found

most effective .

2

One

can

infer

that

the poor

do

not

receive ECT

disproportionately from the

fact

that

many

more

patients

are

treated

with

ECT

in

private

hospitals

than

in

state facilities.

3

This

may

be

due

in

part

to

the

fact that

private

hospitals

have

more

patients

with

depression

and

manic-depressive

disorders,

whereas

government

hospitals

have

more

schizophrenics,

4

and

in

part

to

the more

stringent

regulations

on

the

use

of ECT

in

public

institutions

than

in

private ones,

in

some

states.

The

following

description

of

the early

method

of

giving

ECT

may

explain

why it quickly

became

controversial:

Until

the early

1950 s,

ECT

was

administered

without

premedica-

tion,

anesthesia,

or muscle

relaxation,

and

often

in

full

view

of

other patients.

The

induced

seizure

was

violent

and

disturbing

to

professional

and lay observers

alike,

and although

the

therapeutic

results

achieved

were

far

superior

to any

prior method,

the

treatment

was

often

considered

barbaric,

inhumane

and,

at least,

distasteful.

.  

In

modified

ECT, which

was

introduced

in

the 1950s,

the

patient

is

given

muscle

relaxants

to

prevent violent muscular

contractions

and

oxygen

to prevent

the death

of

brain

cells

when

normal

breathing

is

interrupted.

6

The

procedure

is

carried

out

in

a hospital

on an

anesthetized

patient.

Elec-

trodes are

attached

to

the patient's

scalp

and

an

electrical

current

of between

70

and 150

volts

is

administered

for

between

0.1

and

1.0

seconds,

producing

a

seizure

which

lasts

from 30

to

40 seconds.

The

patient

regains

consciousness

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10

E T

within a

few minutes. The

usual

course

of treatment

for a

depressed

patient

consists

of

6

to

9 sessions, at the rate of

3

per

week.

7

The

modified

procedure

is

in

accord with the recommenda-

tions

of a recent American

Psychiatric Association (APA)

task force

report

on

ECT.

8

The

task force s

recommenda-

tions are

likely

to

set the standard of

care

for

administering

ECT, at

least until

superseded

by

those

of

a later

task force or

by definitive research studies.

9

Effectiveness

o E T

ECT s effectiveness in treating

certain mental illnesses, nota-

bly manic-depressive disorders

and

severe

depression,

is now

well

established.

2

0

Although many of

the

early

studies

which

showed ECT to be

superior

to

antidepressant

drugs

were

methodologically

flawed,

2

 

more

recent, carefully controlled

studies have

clearly

demonstrated

ECT s superiority

over

both placebo and antidepressant

drugs.2 It is not yet

possi-

ble, however,

to identify

in advance

of

treatment

those

depressed patients

who

will

respond to

ECT,

but

not

to

antidepressant

drugs.Y ECT

is not

an

appropriate treatment

for

all

depressions;

24

it

is

primarily indicated in

severe depres-

sion.Y ECT s much

greater

rapidity

of action

may

make

it

preferable

to antidepressant

drugs

for

patients who

are

suicidally depressed3

6

One

study

showed

death

from

suicide

clearly lower

in

patients treated

with

ECT,

27

and it

has been

said that without shock

therapy

many

more

depressed people

would undoubtedly commit

suicide.

ECT s superior

effectiveness has been demonstrated mainly

over

the

short

term; long-term

studies

are less

clear.

29

While

it

often provides

a

rapid

control

of psychotic

symptoms,

effective

follow-up

care

with medications and/or

psycho-

therapy

may be necessary to prevent a relapse.

0

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Some recent controlled

studies have

found

ECT to

be

effective in

certain forms

of schizophrenia.

3

The use

of ECT

plus

neuroleptic

drugs

(those

typically

used

to

treat schizo-

phrenics) has been found

more effective than the

drugs alone

in

removing psychotic

symptoms in some schizophrenic

patients.

3

Since

there

is

some

evidence that

ECT

may remove

the symptoms of

tardive

dyskinesia,

a

movement disorder

which

is a

frequent side effect of

neuroleptic

drugs,

33

ECT

may be

preferable

to neuroleptics

for

some schizophrenics.

ECT may be effective

in some cases where all other treat-

ments

have failed.

A severely retarded

25-year-old man

in

Ohio

was relieved

of his life-threatening

self-injurious

behav-

ior severe,

repeated head-banging)

only

after

ECT was

administered,

reportedly

with

no adverse

consequences

from

the ECT.

Because an Ohio

law forbade the use of ECT

without

the informed

consent of

the

patient,

even in

emer-

gencies,

he was

able to

receive treatment only

after a judge

declared

the

law

unconstitutional.1

4

Despite ECT s

proven effectiveness,

its mechanism of

action

remains unknown. Many physiological

changes occur

follow-

ing ECT,

5

and more than

one mechanism may

account for its

beneficial effects.

6

It is

generally agreed

that

those effects

are

a

result

of

the

seizure

induced

in the brain, rather than

any

stress

or

fear associated with

ECT, or the

memory distur-

bance

that

it

produces.

3

7

The risks

and

benefits

o

T

E T

as given today is

one

of

the

safest procedures

in

medicine.

It

has

an extremely small

mortality

rate,

the

few

fatalities usually resulting from anesthetic

complications.

It

has

considerably

fewer side

effects than

antidepressant

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12

ECT

drugs, and may be

safer

than

drugs for many elderly

patients.

39

There

are relatively

few

patients whose

medical

condition

would make

ECT

unacceptably

risky

0

Unmodified

ECT carried a

high risk

of

vertebral compres-

sion

fractures

and fractures

of the

long bones, but

this

risk

has been

virtually

eliminated

by

the use of muscle

relaxants.

In

a

recent

study

of 25,000

treatments,

the complications,

occurring

at

a rate of

1 per

1 300 or 1 400

treatments,

included laryngospasm, circulatory insufficiency,

tooth

dam-

age

vertebral compression

fractures,

status epilepticus,

pe-

ripheral

nerve

palsy,

skin

burns,

and

prolonged

apnea.

4

 

The seizures

induced by

ECT produce

both

immediate

and

long-term effects

on brain function.

Immediately

after

the

treatment, the patient

is confused

and

disoriented

for

a brief

period, ranging

from a

few minutes

to a few

hours.

There

is

a

temporary memory

impairment,

which

usually

lasts only

a

few

weeks

and is undetectable

by

clinical examination

two to

three months later, or

by sophisticated testing

by

six

months

after

treatment.

4 2

A few patients

may

experience

persistent

memory

loss

and/or

an

inability

to

learn

new

information.

43

The

severity

of the memory

deficit

appears

to

be

related to

the

number of

treatments

and

the method

of administra-

tion,

4

and,

to

a

lesser extent,

to

the

patient's

age

and clinical

diagnosis.

45

The mechanism

of

the

memory

loss

has

not

been

demonstrated.

It has been

suggested

that ECT

may

alter a

patient's

impression

of

his

memory

function rather

than

the

memory

itself,

4

but

to

the patient,

this may be

a distinction

without

a

difference.

The

fact

that

patients'

frequent subjective

complaints

of

persistent memory

loss

are not

borne out

on objective

tests

may simply

reflect

the

lack

of sophistication

of

currently

available

tests, yet

most

patients given

ECT

are able

to

resume

performing

specific

jo tasks

eventually,

according

to

a 1978

APA survey.

47

For

many

patients,

some degree

of

memory

loss

may

not

be too high

a

price

to pay

for the

relief

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of severely

disturbing psychotic symptoms.

A

large majority

(82%) of

a group

of

166

Scottish patients

who

received ECT

said

they

found

the

treatment helpful,

despite

the fact

that

64% reported some memory

impairment, and

some

may

have

suffered

significant

persistent

impairment.

4

3

E T

and

brain

damage

ECT s effects

on

memory

and other

cognitive functions have

led

many

to suspect

that it causes permanent brain damage,

but

as of now there is

no

definitive

evidence to that effect.

9

Much of the evidence

adduced by

opponents

of ECT

to

prove that

it causes brain

damage

is

either anecdotal

or

drawn from the early years of

ECT s use, when conditions of

administration were quite

different from what they

are

today.

 

In a

recent study

of

261

patients treated

with

ECT,

their

scores

on

the neuropsychological

test battery were

within the

brain-damaged

range, both before and after ECT,

but

their

scores

actually improved

after ECT,'

suggesting that any

apparent brain damage

may have been due to their under-

lying illness rather than to the ECT.

Consistent with this

hypothesis is

the

observation

that

the

same

group of patients

showed a slight

rise

in

IQ scores

following

ECT,

with

those

patients

who were most improved

clinically showing the

largest rise.

Studies

of

ECT s

effect on the human

brain are difficult

to

do,

and

most of the

existing data on brain damage come

from

animal

studies, which may not be applicable

to

humans.1

2

Several

organizations opposed to

ECT

(the Na-

tional Committee

for

Preventing

Psychotherapy Abuse,

the

Committee

for Truth in Psychiatry, and

Project

Release)

have requested that

the

Food and Drug Administration

(FDA) perform animal studies to determine ECT s

effects on

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14 E T

the brain.

3

Were

the

FDA to undertake such studies, the

significance

of their

results for humans

would

be

difficult

to

 ssess

A

number

of

former

mental

patients

who were given

ECT

have

petitioned

the

FDA

to

conduct

CT studies of

their

brains

to determine whether any damage has occurredm

Data

resulting from such studies would

lack scientific validity,

however,

given

the

self-selected nature of

the subjects,

the

lack

of

pretreatment

CT

scans

and the

lack

of

a control

group. Any

abnormalities

found might be

due

to the under-

lying

condition

for which

ECT

was given rather

than

to the

ECT.

The question of whether ECT causes

brain

damage

might best

be resolved

by combining rigorous prospective

studies

of EEG, memory, and other functions in

depressed

patients receiving standard ECT

with

histological studies of

animals receiving ECT under conditions similar to those in

which ECT is given to

humans.

55

Based on currently available

data,

ECT appears

to

have a

highly

favorable

risk/benefit

ratio, with many physicians

regarding it as the safest treatment approach under

certain

circumstances. The possibility, as

yet

unproven, that it

causes

permanent brain

damage

has, however

contributed to the

view

of ECT as a therapy of last resort.

The role of

the

FD

The FDA

is

in

a

position to exert some control

over

ECT by

virtue of

its

ability to regulate medical devices including

those used to administer ECT. The FDA assigns each medical

device

intended

for human use to

one

of

three

classifications,

depending on

the degree of

control

it

deems necessary to

provide reasonable assurance of

the

device s safety

and

effectiveness.

6

It

may

change

the classification of a particu-

lar device when new

information becomes

available,

57

but

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due to

the

time lag involved

in

the collection

and

evaluation

of

relevant

data, FDA device

classifications

do not

always

reflect

state-of-the-art

technology

for any given

medical

device.

8

ECT devices

are currently

classified in

Class

III, reserved

for

devices

thought to pose

the highest

risk,

but

the

FDA

is

considering

reclassifying them

into

Class

II.

9

Manufacturers

of

Class

III devices

must submit

to the FDA

a

premarket

approval application

which

includes

information

on safety

and effectiveness

tests

for

the

devices. The

APA

maintains

that sufficient

information

is

available

for ECT

devices

to

warrant

placing them

in

Class

II, which

merely requires

the

development

of a safety

and

performance

standard

satisfac-

tory

to

the

FDA s

Bureau

of Medical

Devices

0

Some fear

that

the

present

classification

may

discourage

manufacturers

from

developing

more

efficacious

treatment

devices.

6

 

The Committee

for Truth

in Psychiatry

has petitioned

the

FDA

to require

that manufacturers

of ECT devices

provide

information

on

ECT

to operators

of

the devices

for

distribu-

tion

to patients.

62

  urrent

research

on E T

Both

the proponents

and

opponents

of

ECT agree

that more

research on

ECT

is needed.

63

The

antipsychiatry

movement

may

have actually

stimulated

ECT

research, leading

those

convinced

of ECT s

benefits

to

try to justify

its

use.6

4

Present

studies

aim

to

discover ECT s

mechanism

of action,

to

explore

ways

of

modifying

its administration

so

as

to maxi

mize

its benefits

while minimizing

its risks, and

to determine

for

which patients and

conditions ECT

may

be

most

benefi-

cial.

65

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16

E T

Researchers

are seeking

objective

evidence to support

patients

subjective

reports

of

memory

loss following ECT

and are trying

to

correlate the degree of memory

loss with

specific aspects

of

the

treatment,

such

as

the seizure thresh-

old,

seizure duration,

and

clinical response 66

Since

individ-

uals

vary considerably in their seizure thresholds,

and since

exceeding

the threshold may contribute to cognitive side

effects,

67

it may be possible to minimize

side effects by giving

the minimal effective

stimulus

necessary

for each patient.

Several

factors

shown

to be correlated with

ECT-induced

memory

loss

have

also been correlated with ECT s

beneficial

effects,

including the

generalization of the

ECT-induced

seizure throughout

the brain

and the

seizure duration,

6 9

suggesting

that

some

degree of memory loss

may be inevita-

ble if ECT

is

to

be effective

Diagnosis

alone

may not predict

who

will respond to ECT.

Certain

categories of depressed

patients are more

benefited

by ECT than

others

°

 

7

ECT may

also

be effective for

condi-

tions

other

than

depression. One

recent

study identified

several other

factors that were significantly

related

to

patients responses

to

ECT.

Unilateral versus bilateral E T

 

number of E T researchers

are

comparing

the

relative

safety

and

efficacy

of

bilateral and unilateral ECT,

with

those

terms referring to

the placement of the

electrodes

on

the

scalp,

and

not to

the location of the

resulting

seizure

in the

brain. A

bilateral

convulsion

is essential for therapeutic

efficiency,

but

unilateral electrode placement

may be

as

effective

as bilateral placement

in producing

the required

convulsion,

while reducing

the

subsequent

memory impair-

ment,

both short-

and long-term.

2

There

is

still considerable

controversy,

however, as

to

whether

unilateral

ECT is as

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effective as bilateral in relieving psychotic symptoms.

3

Some

have

explained

the

variation

in

findings

among studies

comparing

the

efficacy

of unilateral

and bilateral ECT

in

depression by the failure

of different studies to hold constant

significant

parameters

of treatment, such

as

the

interelec-

trode

distance

used and

the

time

of

assessment

of

treatment

outcome,

74

or the

duration

of

the

seizure

7

A

minimum

seizure duration seems

to

be necessary

for

clinical improve-

ment; the APA task

force on ECT recommended

5

sec-

onds.

7

 

With unilateral ECT, there

may be

more

seizures

which

fail to

achieve the threshold

for clinical effectiveness;

this may contribute to

the

impression

that unilateral ECT

is

less

effective

than

bilateral.

7

7

Since 75-80% of

psychiatrists

who

prescribe

ECT use bilat-

eral

ECT

exclusively

78

some

patients may be incurring

unnec-

essary side

effects

if

it is indeed true

that unilateral ECT

confers

the

same therapeutic benefits

as bilateral ECT with-

out the adverse

effects on

memory. The APA task force

favored the

use

of

unilateral ECT,

since

it produced

less

memory loss

but admitted that a consensus

had not yet been

reached concerning the

comparative efficacy of bilateral and

unilateral

treatments

7

9

Unilateral

and bilateral

ECT

may not

be equally

effective

for

all conditions, however. There is

some evidence that bilateral

ECT

may be superior

for

patients with

certain mental

disorders, as some who failed to

respond

to

unilateral

treatment

later responded

to bilateral

treatment.

Attitudes toward

T

Attitudes of

physicians, patients, and

others

toward ECT

range

from

enthusiastic

endorsement

to violent

opposition.

Why does ECT

continue

to

arouse such

strong opposition

despite the mounting evidence

of its effectiveness

and

relative

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18 ECT

safety? E T

may

appear punitive

because

of its

superficial

resemblance

to

electrocution.

Dramatic

portrayals

of

ECT

administered

without

anesthesia

and for

punitive

purposes,

as in Ken

Kesey s

novel

One

Flew

Over

the

Cuckbo s

Nest,

 

and

in

the popular

film

that

was

based

upon

that

novel,

may

have

left an indelible

impression

of

ECT

as

a

form

of sadistic

abuse.

This

impression

may be

sustained

by firsthand

reports

from

patients

who

received

unmodified

ECT,

or observed

others

receiving

it,

years

ago. Some

former

patients who

testified

at

a

recent

international

conference concerning

adverse

effects

from

ECT

referred

to

experiences

that

dated

back 15-20

years.

3

Among

a

group

of

patients

who

received

ECT

more

recently,

most

(82 )

rated

it about

as

upsetting

as

going

to

the

dentist,

or less.8

Among

professionals

as well,

negative

attitudes

toward

ECT

are

highly

correlated

with

ignorance

of

the

procedure

as

currently

practiced.

Psychiatrists,

nurses,

psychologists,

and

social

workers

with

more clinical

experience

and

knowledge

of ECT

were found

to

have

more

positive

attitudes

toward

it 85

Negative

attitudes

toward

ECT

on

the part

of

some

lawyers

and

legal

scholars

may stem,

in part,

from

reliance

on

outdated

or

misleading

medical

information.

86

Examples

of

the

failure

to

research

relevant

medical

information

are

not

difficult

to find:

a 1985

casebook

on

mental

health

law

quoted

from

a 1976

law

review

article

on ECT

which

contained

several

statements

about ECT

known

to

be

false

in

1985.87

In

a

1985

treatise

on

medical

malpractice,

the

two

indexed

sections

on ECT

both

contained

outdated

medical

information

and referred

to old

cases

and articles.

88

A

1986

treatise

on psychiatric

malpractice

was

more

comprehensive

and

accurate than

the previous

two

works,

but

failed

to stress

the

effectiveness

of

ECT

as

a

treatment

for

severe

depression,

and

repeatedly

referred

to

ECT

as

experimental

because

its

precise

mode

of

action

is

unknown.

It

also

stated that

bone

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fractures

may still

occur with ECT, citing

a 1942

source

and

failing to

note that

they

are

exceedingly rare with

modified

ECT

9

In

contrast

to the above,

another

1985

treatise

on mental

health law was found to be quite

accurate

in

its discussion

of

ECT.

°

Unfortunately,

this

book appears

to be in the minority.

As

others

have

noted,

the reliance on

outdated

medical

information

and the confusion

of opinion with scientific

fact

have

contributed to a

legal

view

of

ECT

which

is

often quite

unrealistic.

9

 

This in turn has led to legal

constraints on the

use

of ECT which are

more

severe

than

those

imposed

on

many other

more

dangerous

and

less effective

forms

of

treatment.

  he

NIMH

consensus

panel on

E T

In June

1985

the National Institute

of

Health and

the

National Institute

of

Mental

Health

NIMH) convened

a

Consensus

Development Conference

on

ECT.

Experts testi-

fied

for one and

one-half days before

a

panel

consisting of

nine

physicians,

three

psychologists,

one

lawyer,

and one

public representative about

the indications for

ECT,

the

best

way to administer it,

its

effectiveness,

its

risks and

side

effects,

and directions

for future

research.

The panel

con-

cluded that ECT can be

an effective short-term treatment

for

a narrow

range of severe psychiatric disorders,

including

severe

depressions, acute

mania, and

acute schizophrenia

with affective

symptoms,

but

that

it has significant side

effects,

has been underinvestigated,

and is

still

controver-

sial.

92

The

panel

found that proper administration

of ECT can

reduce

potential

side effects

while still providing for adequate

therapeutic effects. It

found no evidence that ECT causes

brain damage,

but

found that

it

does produce

short-term

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20

T

neurological deficits. The panel

nevertheless concluded that

for certain patients ECT may be the only effective treatment

available. Opposing

any absolute ban on ECT the panel said

the

decision to

offer

ECT

to an

individual patient should be

based on a consideration of the advantages and disadvan-

tages of ECT and of available treatment alternatives.

It

recommended that psychiatric residency

programs

include

complete

ECT training and

that more

research

be

devoted

to

ECT.

The chair of the panel recommended a national survey

on ECT use

in

the

United

States noting that

ECT may have

been overutilized

with some patients

and

underutilized with

others

since it is largely unavailable

in

V.A. hospitals or

state

institutions.

9

Several psychiatrists criticized the conference for having

non-

experts on

the panel giving

a

disproportionate

amount

of

time

to

disgruntled patients

being too

cautious in

its

en

dorsement of ECT and

not

imparting a sense of the actual

risk/benefit ratio

of

the procedure.

4

Carol

C.

Nadelson

then

President of

the

APA said that

the

report

exaggerated

the

degree of controversy about

ECT and

that its

recommenda-

tions

for

use were too general

in

some instances and

too

specific

in

others. She feared

the

report

might impair

efforts

to get

the FDA to change its classification of ECT devices

to

a

less

restrictive

one

95

  itigation

based on

E T

Formerly a frequent

source

of

malpractice

claims

against

psychiatrists 9 ECT has given rise to relatively few lawsuits in

recent years. This may be due both to its declining use and

to

the use of modified ECT

which

results in fewer physical

injuries especially

bone fractures. The APA-sponsored liabil-

ity

insurance program which insures a majority

of

the

psychiatrists carrying liability insurance in the

United

States

today

no

longer imposes a surcharge on

psychiatrists who

prescribe ECT.

97

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Whereas the

early

cases usually alleged a

physical

injury or

death resulting either

directly

or indirectly from

ECT,

98

recent

cases are more

likely to

involve lack

of consent

or of

informed consent to

the

procedure,

and/or a

violation

of

the

patient s

constitutional rights. Relatively few cases

allege

memory

loss

or other neurological deficits

as

the

major

injury,

considering

the number of subjective

complaints

in

this

regard.

99

One

such

case, 00

involving

a

former California

attorney

who

claimed he

was no longer

able to practice

his

profession

because

of

the

memory

loss

engendered by

ECT,

may have

been instrumental in getting

the

city

of

Berkeley

to

ban ECT

within its

borders.

10

 

A recent (1980)

review of

34

malpractice

cases based on ECT

found

relatively few in

which

the

plaintiffs

were successful.

02

The legal issues raised, in decreasing

order

of frequency,

included

negligent

follow-up and

care

of patients

(19 cases),

lack

of consent

or inadequate

consent 10 cases),

negligent

administration of

ECT

(6 cases),

and

breach of

warranty

(3 cases).

Many

cases

involved

multiple allegations.

The

author

advised

physicians administering

ECT to

do

the

following to

minimize their potential liability: obtain the

patient s

informed

consent,

obtain

legal

authority to treat

the patient who is

not

competent

to consent, use

accepted

procedures,

avoid outpatient

ECT whenever

possible,

pay

close attention

to patient complaints, keep

good

records, and

refrain

from

promising

a

perfect

result.

0

1

3

As

in

all

negligence cases,

the

plaintiff

claiming an

injury

from ECT must

establish

a

deviation

from the

appropriate

standard

of care

and a

causal

relationship between the

deviation

and

his

injury.

Despite the high risk of bone

fractures

with early,

unmodified

ECT, courts

consistently

refused to apply the

doctrine of

res

ipsa loquitur.

°

That

doctrine

enables a plaintiff

to get his case

before a jury

without

testimony on

the standard of

care

where the treat-

ment results in an injury to a

previously healthy organ not

directly

involved in the treatment.

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22

ECT

A

psychiatrist

may

be

liable

for

breach

of

warranty,

if

he

promises

the

patient

there

will

be

no

adverse

effects

from

the

treatmentyos

or

for

failure

to

obtain

informed

consent,

if

he

fails

to

mention

a material

risk

that

later

occurs.

Failure

to

advise

the

patient

of

a

material

risk

of

ECT,

or

falsely

advising

the

patient

that

the

treatment

poses

no

risks,

has

been

held

to

be

a

form

of

malpractice.'

The plaintiff

may establish

a prima

facie

case

of

negligence,

sufficient

to

avoid

a

judgment

of

nonsuit,

by

showing

that

the

defendant-physician

has

violated

the

APAs

standards

for

administering

ECT

0 7

The

plaintiff

still

risks

dismissal,

how-

ever,

if

he

fails

to

establish

a

causal

connection

between

the

violation

of

the

standard

of

care

and

the

alleged

injury.

0

8

Expert

testimony

is

generally

required

on

the

issue

of

causa-

tion

in

cases

alleging

physical

injury

caused

by

ECT. '

9

Where

there

is

conflicting

expert

testimony

on

the

issue

of

causa-

tion,

a

court

will

usually

allow

a

case

to

go

to

a

jury.

t

1

0

Should

a

bone

fracture

occur

during

ECT,

failure

to

adminis-

ter

a

muscle

relaxant

may

provide

a basis

for

liability. '

In

one

case

stemming

from

ECT

treatments

administered

in

1971,

the

physicians

were

not

held

negligent

in

failing

to

administer

a

muscle

relaxant,

where

experts

had

testified

that

either

procedure

i.e.,

with

or

without

muscle

relaxants)

was

acceptable,

although

the

chance

of

fracture

was

2-30%

when

no

paralyzing

drug

was

used.1

2

The

issue

is

unlikely

to

be

decided

the

same

way

today,

however,

in

view

of

the

stan-

dards announced

by

the

APA

task

force on

ECT in

978 Y

A

physician

may

be

held

liable

for

giving

ECT

treatments

that

are

unnecessary,

or

excessive

in

number,

or

based

on

a

mistaken

diagnosis.

If

ECT

has

been

properly

ordered,

but

negligently

administered,

the

physician

who

ordered

the

treatment(s)

will

not

be

held

vicariously

liable

for

the

acts

of

the

shock

team

where

he

was

not

present,

did

not

direct

the

treatments,

and

had

no

control

over

the

terms

of

the

team's

employment.Is

A

psychiatrist

may

be

found

liable

for

dis

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charging

a

patient

prematurely

after ECT treatments, if the

patient's ECT-induced confusion contributes

to

a subsequent

physical injury.

 

6

  laims

based

on

l ck of

consent

or lack of

informed

 ons nt

A patient

who claims

he

gave

no consent

to ECT, or

that

he

gave a

consent which was invalid because of

incompetence,

may

bring a suit

for

battery or for a violation of

his

constitutional rights

without having to prove any physical

injury resulting from

the ECT.

A patient who claims a lack of

informed consent

to ECT, however, must prove that he

suffered a

physical

injury

7

attributable to ECT, that

he

was

not

warned in advance

of

the

specific risk of that

injury

occurring, and

that had he

been

warned

of

the

risk,

he would

have refused the treatment. '

In an early case

based

on

lack of consent to ECT,

119

the court

implied that

the patient's husband could consent

to ECT

on

her behalf,

provided he acted in good faith, but in another

case decided

at

about

the

same

time,'

2

the fact that the

patient's

wife had

signed

a

consent form was held

not

to

deprive the patient

of

his claim, where

he did

not

authorize

her

to sign

it. The psychiatrist

who proceeds

with

ECT on the

basis of

a family member's consent

thus risks an adverse

judgment in

the

event that he is

sued.

Statutory provisions

as

to

who, if

anyone,

may consent

to ECT on

behalf

of an

incompetent patient, and under what conditions, vary widely

from

state

to state.'

2

' Many of the statutes

are highly

restrictive, forbidding implied consent to ECT even in

emer-

gency

situations.

The

therapeutic

privilege

provides

an

exception

to

the

physician's duty

to

obtain informed consent

when

the

proc-

ess

of

giving

the

patient

the

necessary information

may

itself

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24

T

prove harmful.'

 

A

1957

case applied the

therapeutic

privi-

lege to

relieve

the

physician of

his

duty to warn the patient of

the

hazards

of ECT.

3

This

case,

which

another

court called

  rather

bizarre,

1

24

is

one

of

a very

small

number

of

cases

that

have actually

applied

the

therapeutic

privilege,

and

n y

not

be followed today.2

Expert

testimony

may

or

may

not

be required concerning

which

specific

risks

of ECT

the defendant

should have

disclosed,

depending on the particular disclosure

rule

in force

in the jurisdiction,121 and on

the

magnitude

of the

risk that

materialized. One

case

27

held that

expert testimony

was not

required on the issue

of the physician's

duty

to

disclose the

risk

of fractures, where the high incidence

of

fractures (from

18 to 2570, in studies cited

in the

opinion) was

a

well-known

fact,

but a

different case n

held that expert

testimony

was

required with respect to the

duty to disclose the

risk of

prolonged coma with

brain

damage after insulin

shock

therapy.

In

Mitchell

v

Robinson,

2

9

one of the defendant-physicians

testified

that in

the mental and emotional

state that

[the

patient]

was in at

the time of

the

[informed consent]

confer-

ences,

he could

not

possibly

have an accurate memory

of the

conferences

after the

passage of a

number of

years.

Since

this is likely to

be true

of

most patients

undergoing ECT,

it

raises

an

interesting

question as to how

physicians may

protect themselves

from

false allegations

that they

failed to

warn the patient

of

inherent

risks

of

the procedure.

The fact

that the

major

risk

today is

not

that of fractures, but

of

memory impairment, makes

the question

all

the

more acute.

Wyatt

v

Stickney

I declared that

the mentally

ill must give

their informed

consent before being

subjected to

unusual

or

hazardous

treatments,

placing ECT in that category,

along

with

lobotomy,

and

adversive

(sic)

reinforcement condi-

tioning. Wyatt

v

Hardin

3

  adopted

more

extensive proce-

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dural

precautions with

respect to ECT,

including

the consent

of an Extraordinary

Treatment

Committee.

Other

courts have since

concurred

that

mental illness per

se

should not

deprive

patients

of their

right to give

informed

consent

to

medical

treatment,

including

ECT, but have

differed

in

the

means

by which

they

chose

to protect

patients'

rights.

Patients

who

are

legally competent

generally have a

right

to refuse

ECT,

as well

as

a

right to give

informed

consent

to

the procedure.

Even

involuntarily committed

patients

are

presumed

competent,

unless

their incompetence

has been

judicially

determined.

Where

the

patient

is

legally

incompetent

to

give consent,

the

required consent

may be

given

by

a

court,

by

a court-appointed

guardian,

or

by some

other party

designated

by

a

court

or

statute,

applying

the

doctrine of substituted

judgment.'

3

In

a number of jurisdic-

tions,

the gaps in

statutes and regulations

pertaining

to ECT

have been

filled

in

by

subsequent

case law

In

Price

v

Sheppard,

the

Minnesota Supreme

Court

held

that

ECT

was

not

cruel

and

unusual punishment,

and

that

the

director

of

the

state

mental

hospital, who

had

acted in

good

faith

and

without knowledge

that he

was

possibly

violating

a constitutional

right in giving

ECT

to an

involun-

tarily

committed

minor,

was

immune

from

liability both

in

tort

and

under

the Civil

Rights Act.

The

court

held

that

in the

future,

however,

a

legal

guardian

would

have

to be

appointed

to consent

to

ECT on

behalf

of

an

incompetent,

and

an

adversary

hearing

would

have

to

be held

before E T

could

be

ordered.

A

Minnesota

appellate

court

placed additional

restrictions

on

the

authorization

of ECT for an

incompetent patient

in In re

Alleged

Mental Illness

o

Kinzer.

4

It reversed

the

trial

court's

order, which

authorized future

treatment

should the

patient's

symptoms recur,

despite

the

fact

that

ECT had been

effective

in curing

the

patient's

symptoms

in

the past. Ruling

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  6

ECT

that

a

hearing must be held before each series of ECT

treatments,

and that authorization orders

must contain rea-

sonable time

limits,

the court held the trial

court's

order

invalid

because

it

authorized ECT

for an unlimited duration

and

was

not

based on a

finding of

present

medical

iecessity

made after

an adversarial

hearing.

A patient

may

be

sufficiently mentally ill to require further

hospitalization, yet

may

be legally competent

to

consent

to

or

to

refuse

ECT,

according

to

a

New

York

court

which

denied

a

hospital's

request for authorization

to administer

ECT

to a

refusing patient, stating:

It

does not matter whether this

Court would

agree with her

judgment; it

is enough that she

is

capable of

making a

decision, however unfortunate that

decision

may

prove to be.'

35

A Kentucky appellate court has

held

that,

absent a

judicial

declaration of incompetence or an emergency posing an

immediate danger

of

harm to

the patient or

others,

an

involuntary patient may

not be

compelled

to

undergo ECT

against

his will simply because it is in his best interests.

36

While the

court's

decision may have been compelled

by a

Kentucky

statute

37

which gave patients

the right

to refuse

  intrusive

treatments, such as ECT,

it is

consistent with the

law in most states that the mentally

ill are presumed compe-

tent,

and that

a person who

is

legally

competent

may

refuse

treatment

that

others

deem

to be

in

his

best

interests.

3

 

Where ECT is administered

in a hospital,

the

duty

to

obtain

the

patient's

informed consent belongs

to

the physician, not

the

hospital.

3

9

Immunity

or

ordering or

administering

E T

Where the defendant

is

a state or

V A

hospital, or an

employee of

either,

governmental immunity will often

be an

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issue

in

the

case.

In Lojuk

v

Quandt

4

 

a patient

sued

a

V.A.

hospital

and the physicians

who

treated him

there with ECT,

claiming

that his

signature

on

a

consent

form

was either

forged

or obtained without

his comprehension.

The

Court of

Appeals

for

the

Seventh

Circuit held

that although

the

United

States

was

immune

from liability

for

battery

under

the

Federal

Tort Claims

Act (a

total lack

of

consent

being

defined

as a battery under

the

relevant

state

law), the

psychiatrist

was

entitled

to a

qualified

immunity

at most.

The

medical center

directer

could

not be held

liable either

on the

theory that she

issued

an

unconstitutional

policy

(as she

lacked

notice that patients

were

being

deprived

of

their

rights)

or

on the

theory of

inadequate

supervision.

 nLojuk

v

Johnson

41

the

Court

of Appeals

for the Seventh

Circuit

held that

the psychiatrist

in the

above

case

was not

entitled

to absolute

immunity

in light

of the

statutory

indemnification,

but that he

was

entitled

to

a

qualified

immunity

because

the

patient s

right

to

refuse

treatment

was

not clearly

established

at the time of

the

event

(March

1979).

Can a psychi trist

be sued

for not ordering

ECT

In

Gowan

v

United

States

42

the guardian

of

a patient

who

attempted

suicide five

days

after being

discharged

from

a

V.A.

hospital

sued,

alleging

various

acts of

malpractice

including

the

discontinuation

of the

patient s

medication, the

failure

to

require

ECT,

the

form of psychotherapy

given,

and

an

inadequate discharge

plan.

The

court

found

for the

defendants,

holding

that

expert testimony

supported

all of

the actions

taken,

and

that

it was

not

malpractice

not to give

ECT

where

it

was not

available

at the facility,

and it is

not

used

to

the

extent

that it

was previously.

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28

T

  onsent

to

E T in

liforni

In

1974

California

enacted

the

strictest statute

to

date with

respect to

consent

to

ECT.

4

1 In Aden

v Younger, '

three

of

its provisions

were

struck down

as unconstitutional:

the

requirements

that

treatment

must be critically

needed

for

the welfare

of the

patient, that

a

responsible

relative

be

informed

of

the treatment,

and

that

the

decisions

of compe-

tent

and voluntary

patients to

undergo

ECT

be

subjected

to

substantive

review.

The

court found

a

First

Amendment

issue

to

be

involved

because

the

state was

attempting

to regulate

the

use

of

procedures

which

touch upon

thought processes

in

significant

ways. It upheld

provisions

requiring

the establish-

ment

of

a

reporting

system

and the

disclosure

of

all possible

risks

and

side

effects

of ECT, saying

the

equal

protection

clause was

not

violated

by special

consent

requirements

for

mental

patients because

their

competence to

accede

to

treat-

ment

voluntarily is

more questionable

than

that

of

other

patients.

4

In

In re

Fadley,

46

a

California

appellate

court

ruled

that

the

trial court's

review of

a

physician's decision

that

ECT was

warranted for

an

87 year old

woman

under

a conservator-

ship

was inappropriate

where

legislation

provided

that

whether

treatment

was

indicated

and

was

the

least

drastic

alternative

available

was a

medical

decision.

The only

issue

properly

before

the trial court

was the patient's

competence

to

give written

consent

to

the

proposed therapy.

The statute

did

not

specify

the

standard

of proof

to

be applied

in finding

a

lack

of capacity

to

consent

to

ECT,

but

another

case'

47

held

the

finding

must

be supported by

clear

and convincing

evidence,

the preponderance

of

the

evidence

standard

being

insufficient

because

the basic

right of privacy

is

involved.

A

California

appellate

court interpreted

the clear

and

convincing

evidence

standard

for finding

inability to

give

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consent

as

so

clear

as

to leave

no substantial

doubt.

148

Applying

the

California

statute s definition

of incapacity

to

give

consent

(that

the patient

be unable

to understand,

or

intelligently

act

upon,

information

required by

statute to be

given

him), the

court

found no substantial

evidence

that the

patient was

incapable

of

giving

consent,

and

reversed

the

Superior

Court s

finding

that the

patient s conservator

could

give the

necessary

consent.

The

statute

provides

that

a

finding

of

incompetence

may

not

be

based

solely on

a

diagnosis

of

mental

illness.

Although

severely

psychotic,

the

patient had

lucid periods

in

which

he

appeared

to understand

the risks

of ECT,

and his objections

to it were

based

on his

previous

experience

with it

and on

the

possible

side

effects,

including

permanent

memory

loss

The

court said

the

fact

that

his

fear

of

ECT was

at

times irrational

would

not negate

his ability

to consent

if

he also had a rationally

based

fear,

but it implied

that

its

decision

might

have

been different

if

ECT

treatments

had

been shown

to

be

a

life-or-death

matter.

The

Berkeley ban

on

ECT

In

1982, the

Coalition

to

Stop

Electroshock,

a patients

rights

group,

gathered

1,400 signatures

from

Berkeley

voters

to

put

the

issue of enacting

a

city ordinance

to

ban

ECT on

the

ballot. In

November,

62% of the

voters approved

the

ban.

Henceforth,

physicians

who

administered

ECT

in

Berkeley

could

be fined

500 and

imprisoned

for

six

months;

yet

they

could

still

administer

ECT

legally

in Oakland,

only

15

minutes

away

Since

only 48 patients

were

given ECT

in

Berkeley

during

all of

1981,

the referendum

was

not

a

response

to a massive

abuse

of ECT,

although

some

reported

instances

of abuse may

have inspired

the

referendum.

Despite

the ban s

limited impact,

some

psychiatrists

criticized

it

for depriving

patients

of their

right

to appropriate

treat-

ment

and

intruding

on the

prerogatives

of the

medical

profession.

4

9

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30

T

Several

psychiatric associations

immediately

brought

suit to

enjoin

enforcement of the

ordinance.

The Superior Court of

Alameda County declared the

ban unconstitutional and

issued a

preliminary

injunction

against its enforcement,

pending

a

trial.

10

In February

1986,

the California

Court

of

Appeal

affirmed this decision, holding that

the

regulation of

ECT is

a

matter of

statewide,

not local, concern,

and that the

ordinance directly conflicted with state law

and was pre-

empted by

state

law.

5

  The court

noted

that

the state

legislative scheme evinced

a

desire

to

preserve

the

availability

of ECT while

enacting stringent safeguards on its use,

such as

the requirement of voluntary, written, informed consent of

the

patient

or

his legal

guardian. In

view of its decision

on

these issues, the court found

it unnecessary

to address the

right of privacy issue raised by

plaintiffs.

The Berkeley City Council

voted to appeal

the

decision

of the

California Court of Appeal,

but

when the California

Supreme Court refused to hear

the

appeal,

3

the City Council

voted to cease

its

attempts

to

ban ECT.

4

Other attempts to

ban or

restrict the

use

of T

  bill to ban E T in Vermont died in the state senate, but its

proponents promised to

introduce a

modified

version which

would

require

the

patient s

informed consent to ECT. As in

the Berkeley

case,

there

was

no

pressing

need for the

legislation, with

only two

hospitals in

Vermont

performing

ECT and

both

of those

following

stringent informed consent

guidelines.

55

While attempts

to ban

ECT

entirely have proven

unsuccess-

ful to

date,

its use is subject

to

heavy restrictions in many

jurisdictions, comparable

to

those

for

psychosurgery, and

more

severe than

those applicable

to medication.

6

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The Supreme

Court

of Washington recently set forth detailed

requirements

to be

followed before a

court may

order

ECT

for

a

nonconsenting patient, in In

re Detention

o Loretta

Schuoler.1

7

The

court rested

its decision

on

the constitutional

right of privacy, which it said

is

retained by the involuntarily

committed mental

patient

and

includes the

right

to be

free

from

unwanted

ECT.

Before ECT

can be administered

to a

nonconsenting patient, it held, a judicial hearing must be

held, at which the patient

must

be present

and

represented by

counsel.

The court must make

findings concerning

the

patient s wishes any significant interest the state may have in

whether the

patient

receives

treatment, and whether ECT is

both necessary and effective

in satisfying

the state s interest.

The state must prove

each

element justifying the authoriza-

tion

of ECT with clear, cogent, and

convincing

evidence. The

patient s wishes with

respect

to

ECT may

be determined by

applying

the substituted judgment test.

The Washington

statute

5

' provided

that

involuntarily com-

mitted patients should

have

the right not to

consent

to

shock

treatment

or surgery, unless

ordered

by a

court pursuant

to a

judicial

hearing

in which the person

is

present and

repre-

sented by

counsel, with

a

court-appointed expert designated

by

the patient or his counsel to testify

on

his behalf. In

Schuoler the

patient s

attorney claimed that the

statutory

procedures were constitutionally inadequate, and

that the

trial court abused its discretion

by

denying her

a

continuance

to prepare for the ECT hearing,

and a

stay of

the order

pending appeal. The trial court

had authorized

ECT treat-

ment

for

the patient at the discretion of her treating

psychia-

trist

after hearing two psychiatrists

testify

that

the patient

had shown

no improvement

while

on

drug therapy, but had

in the past been

able to

function

outside

of a mental

institution

as the result of ECT.

5

'

Although

the Washington Supreme

Court recognized that

a

major

goal

of

the

involuntary

commitment

and treatment

scheme [of

the

Washington statute] is to replace inappro-

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3

ECT

priate,

indefinite

commitment with

prompt evaluation and

short term treatment, '

6

it

found that

the trial court should

have acceded

to

plaintiff's

request

for

a

continuance

(of

an

unstated

amount

of

time).

The supreme

court

apparently

assumed that

the

patient

was incompetent,

as the

experts

had

testified,

but

found

the

trial

court

had erred

in failing to

conduct

the investigation necessary

to

make

a

substituted

judgment for

the patient.

6

 

Among

the factors

to be

consid-

ered

in

arriving at

such

a

judgment

the

court included:

the

patient's

previous

and current

statements and religious and

moral

values

regarding medical

treatment

and electroconvul-

sive

therapy, as

well as views

of individuals that might

influence the patient's

decision.

Absent from the list were

the

patient's

interest

in getting prompt

relief from

her psychotic

symptoms

and

avoiding

long-term

hospitalization.

The

court found

that

the tremendous

financial

burden

imposed upon

the

state

by

the

patient's

repeated hospital

admissions

satisfied

the

compelling

state interest

necessary

to

override the

patient's

fundamental

liberty

interest in

refusing

ECT.

It

found

ECT both necessary

and effective for

further-

ing that

interest

based

on the physicians'

testimony that

drug

therapy did not help

the

patient,

but that with

ECT

she

had

an 80

chance of

recovery.

62

Yet,

in upholding

plaintiff's

claim

that the trial

court erred

in

not

granting

a continuance,

the court said

that no

emergency

was present (without

defining

emergency),

and

that drug

therapy was available.

63

This

case

has

been discussed

at

length because

it

is

(at

the

time of this

writing) the most

recent case dealing with

the

patient's

right to

refuse ECT, yet it

embodies many

of

the objectionable features

found

in

prior

cases involving

the

rights

of mental patients to

refuse

treatment. The

court

repeats

familiar

legal

formulas without

attending to

the real

patient

and

societal

interests at stake. Like

other

courts and

legislatures

which

previously dealt with similar

issues, the

court

employs terms

such as intrusive

treatment,

compe-

tence,

and

emergency,

without

defining

them for the

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 ompetency

 mergency

Intrusiveness

future

guidance

of physicians who will be

subject

to

its

mandate.'

4

The lack

of meaningful

standards

creates

the

danger that regulations

intended to

protect

patients may

instead

deprive them

of

needed

medical

treatment.'

65

Competency

is a

poorly

defined

concept

that has

different

meanings for

different purposes)

66

The

standard

for compe-

tency to make

treatment decisions

may vary,

depending on

the

risk/benefit ratio

of the proposed treatment.

67

The

last

few

decades

have

seen

a separation,

in

law,

between

commit-

tability

and competency

to refuse treatment,' but

recently

there

have been

signs

of

a

possible

reversal of that trend.'

69

Many statutes

and cases contain

exceptions to

the

right to

refuse

treatment

in

emergency

situations, but

the

definition

of emergency

varies from

place to place

and

is

often unclear.

What judges

consider

to be

an emergency

often differs from

a psychiatrist's

concept of

an

emergency.

70

In

some

states,

exacerbation of

a

mental

illness

is considered an emergency,

while

in

others it

is

not.

Many judges

will

authorize treatment

only for the duration

of

the

perceived

emergency,

targeting

for

treatment

the immediate threat

of violence, rather than

the patient.1

7

  This

is evident

in the tendency to

limit

treat-

ment authorization

orders, noted

above.

Many of the statutes

and decisions

involving

ECT describe

it

as an intrusive

treatment,

without defining that term

or

comparing

the relative intrusiveness

of ECT with

other

treatments, with

confinement, or

indeed, with continued

mental

illness.

72

The

claimed

intrusiveness

of

ECT

is

then

used to justify

the imposition of

strict procedural require-

ments

before

it

can

be

authorized for an

incompetent

patient.

Shapiro

has made

one of the

few

attempts

to

define the

intrusiveness of

a

psychiatric treatment,

listing

the following

six criteria:

(1) the extent

to

which

the effects of

the

therapy

upon

mentation

are reversible;

2) the extent

to

which the

resulting

psychic state

is foreign, abnormal,

or unnatural

for

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34

T

the person

in question, rather

than simply

a

restoration of his

prior psychic state; (3) the

rapidity with which the

effect

occurs;

4)

the scope of the change in the total

ecology of the

mind's functions;

5)the extent to which one can resist acting

in ways impelled

by

the

psychic effects of the therapy;

and 6)

the

duration of the

change.

173

Reisner asks,

appropriately,

whether these

criteria

are satis-

factory and whether

they would

put

therapists

on notice as to

which

treatments

would

be

regarded

as

intrusive.

74

Since,

as

Shapiro

admits,

175

his

definition of

intrusiveness

overlaps

with that of effectiveness, the

most effective psychiatric

treatments

would be

considered

the most

intrusive

and

hence,

paradoxically, the most difficult

to

obtain

for those patients

most

in

need of

treatment

(the

ones whose illness

has

rendered them incompetent to

make treatment

decisions). An

additional problem

with

Shapiro's

definition is

that the

existence of Criteria 2,

4, and 5 would be difficult, if

not

impossible, to determine.

Simon

has

pointed

out that for certain patients, ECT may

be

less

intrusive than

drugs,

by producing more

rapid remission

of

symptoms

with

fewer side effects.

76

He

notes

that

psycho-

logical

therapies, typically rated lowest

in intrusiveness by

courts and

legal commentators, may in

fact

be

highly

intru-

sive, as

for example when

patients

make incriminating state-

ments in

forensic interviews.

77

Legal

formulations

such

as

the

least intrusive alternative or the least

restrictive

alternative

are

not readily

applicable to the clinical situa-

tion, he says, and

not always consistent with

good

medical

practice,

because of the diversity

of

patients

and their

treatment needs.

  egal

and medical viewpoints

contrasted

While

a number

of psychiatrists

have criticized the legal

framework

used by the

courts

for

decision

making

with

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respect

to ECT and

other

treatments-

for

the mentally

ill,

some

lawyers

have

defended

it

as appropriate

to

a

democratic

society.'

79

Framing

the

issues in

terms of

legal rights

and

the

exercise

of autonomy

almost

forces one

to conclude

that

judges

are

the only

appropriate

decision makers,

and

that

any problems

in

the execution

of the law

can be alleviated

by

refining the

legal concepts

involved.

In medicine,

the

term iatrogenic

is used

to

describe

illnesses

or

problems caused

by

medical

interventions.

Analo-

gous terms

have been

suggested for

the

problems created

by

judicial

decisions in

the right-to-refuse-treatment

cases:

  juridicogenic

 

0

nd

critogenic.

  j

l Examples

of

juridico-

genic

or critogenic

conditions

include

the adversarialization

of the

doctor-patient

relationship,'

8 2

and

the tremendous

costs

imposed

on

the judicial

system, the

professionals

involved,

and the

patient

by requiring lengthy

judicial

hear-

ings before a

nonconsenting

patient may

be treated.

3

  roblems wit

the su stituted

judgment

approach

Much of

the

criticism of

the right-to-refuse-treatment

deci-

sions

is leveled

at

the application

of the

substituted

judgment

doctrine.

Stone

wonders

how a

judge

with

no

psychiatric

training

and a

single exposure

to

the patient can

possibly

arrive

at a

valid substituted

judgment, or

indeed, if

that

phrase

has

any meaning

in the

context

of

a

mentally

ill

patient. He

says

that

in practice, judges

execute

their

substi-

tuted

judgment mandate

by

either

routinely

ordering

treat-

ment,

after lengthy

hearings,

or by

deferring

to

the

judgment

of psychiatrists.114

Gutheil

notes a

paradox inherent

in the doctrine

of

substi-

tuted judgment:

the

decision maker

is

asked

to decide

whether

a

sick patient

would

decide

to take

drugs if

he

were

healthy, in

which case

he

would

not need the drugs,

and

says

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  6

ECT

that

in

most

cases this

information

is

unavailable

because

people

don't

usually

consider

this

issue

before

becoming

mentally

ill 185

Gutheil

and

Appelbaum

believe

that

the

substitute

decision

maker

who

lacks

the

requisite

knowledge

of

the

patient's

prior

decision

making

and

his

present

wishes

with

respect

to

the

proposed

therapy

is likely

to apply

the

equivalent

of

a

best

interests

approach.'

86

They

therefore

suggest

that

the law

sanction

that

approach

in

the

absence

of

an

unambiguous

indication

of

the

incompetent's

desires

and

recommend

the application

of

a presumption

that

treatment

is

in the

patient's

best

interests

when

it has

a

good

probability

of

restoring

competency.

7

This

seems

a reasonable

approach

when

the

patient

is

suffering

from

a

serious

condition

for

which

no

alternative

treatments

seem

effective,

and

when

the

proposed

treatment

has

a

favorable

risk/benefit

ratio.

E T

and

informed

consent

The

three

essential

elements

of

informed

consent

are

a

competent

patient,

the

communication

of

adequate

informa-

tion

to

form

the

basis

of a

decision,

and

the

absence

of

coercion.

In

the

typical

candidate

for

ECT,

the

presence

of

all

three

may

be

questioned.

  ompetence

of

the

candidate

for

T

ECT

is

most

likely

to be

considered

for

patients

who

are

severely

depressed,

often

to

the point

of

being

suicidal.

The

patient's

emotional

state

may

cloud

his

judgment

and

render

him incapable

of

absorbing the information

given.

1

8

Once

a

course

of ECT

treatment

has

begun,

the

memory

deficit

induced

by

the

treatment

itself

may

make

it

difficult

for

the

patient

to

retain

the

relevant

information

necessary

to a

rational

treatment

decision.

8 9

Some

have

advocated

a

contin-

uous

consent

process

during

a

course

of

ECT

treatments, ,

but

the

feasibility

of

this

approach

has

been

questioned

because

of

the

temporary

effects

of

ECT

on

the

patient's

competence.

91

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What

information

should

communicated

to the

patient

Physicians

differ

among

themselves as

well as

with the

legal

profession,

regarding

the

competence

of

patients

to

decide

for or against

ECT and

whether

treatment

should

be

given

against

the

patient s wishes.

Merskey

believes

that ECT

should

be given

to nonconsenting

patients

under

certain

circumstances,

because

of

the

physician s

ethical

commit-

ment

to

attempt

to

relieve

suffering

and prevent

suicide and

states

that the

patients

are

usually

grateful

afterward.

92

Culver

et al. think

that physicians

should respect

patients

informed

decisions

to

reject

ECT

except

in

cases where

they

might

die

without

treatment.

93

Most depressed

patients

ap-

pear

to

be

capable

of making

an

informed

decision,

they

say,

and

few refuse

ECT,

possibly

because ECT

is usually

only

suggested after

other

treatments

have

failed and the

patient is

eager to

have his suffering

relieved. '

Some

opponents

of

ECT

believe it

to

be so harmful

that

one

could

not rationally

consent

to it.

9

Breggin,

a

vocal oppo-

nent

of

ECT who would

like to see

it abolished

completely,

would

not prohibit it for voluntary patients

in

the private

sector,

as

he believes

that

would

be an

abridgement

of their

and

their physicians

constitutional

liberty

interests.

9

Others

have

argued

that involuntary

patients

should

also

be able

to

receive

ECT,

as

they

have as

much right

to the

appropriate

treatment

as

voluntary

patients.

Since much

is

still

unknown

about

ECT s mechanism

of

action and

long-range

effects, even

the

best-intentioned

physician

will

be

unable

to

communicate

all

the

information

the

patient

might want

to

have

before making

a decision.

Standard

informed consent

doctrine requires

that

patients

offered

E T

be informed

of the

possible

risks and

benefits of

ECT, the

risks and

benefits

of

any alternative

treatments

available,

and the

risks and benefits

of undergoing

no

treatment.

98

Is there

sufficient

evidence

of the

risk of

perma-

nent memory

loss

to require

that

physicians

disclose it?

9

Should

the patient

be informed

that

a

possible

risk of

not

accepting

ECT

is that

he will

commit

suicide or would

that

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38

ECT

entail

the danger

of

a self-fulfilling

prophecy?

One author

suggests

that

patients

be

told

that

ECT

has

an

excellent

chance

of alleviating

depression,

a

small

chance

(perhaps

10-

50 ,

but

not

known

exactly)

of causing

minor

memory

problems

that

may

persist

for

6-12

months,

and

a rare

chance

(possibly

1 ,

but also

not

known)

of moderate

to

marked

memory

problems

that

may persist

for longer

than

a

year,

and,

in extremely

rare cases

be

chronic

and

disabling.M

Since

the

ability

of non-mentally

ill

persons

to

evaluate

statistical

risks

has

been

shown

to

be

questionable,2

°

'

how

much

more

so

is that

likely

to be

true

of

a candidate

for

ECT?

Most

of

the empirical

studies

of

mental

patients'

ability

to comprehend

information

regarding

proposed

ther-

apy

have

shown

it to

be

poor,

but

the studies,

which

usually

deal with

antipsychotic

drugs,

have

been heavily

criticized

on

methodological

grounds,

and

some

have

argued

that

the

mentally

ill

are

no

less able

to

comprehend

such information

than the

non-mentally

ill

patient.m

Statutes

in some states

mandate

specific

information

to

be

given

to

patients

advised

to undergo

ECT1

3

California

requires

that

patients

be

given

some

information

about

the

risks

of

ECT which

a

number

of

physicians

regard

as

erroneous,

4

illustrating

the danger

of

specifying

in

a

statute,

on the basis

of

incomplete

medical

data,

the

information

to

be

disclosed

during

the

informed

consent

process.

  oercion

Some

might

argue

that

the

situation

of

the

typical

ECT

candidate

is inherently

coercive

in

that

the consequences

of

refusal may

be

a continuation

of intolerable

symptoms,

a

lengthy

period

of

institutionalization,

or

both.

Repeated

conversations

with an

institutionalized

patient,

urging him

to

undergo

the

proposed

therapy,

may

appear coercive

to the

patient.

Empirical

studies

of

drug refusal

have

shown

that

in

most

cases patients

eventually

were

talked

into

accepting

the

drugs

or were

treated

over

their

objections.

2

5

One study

of

treatment

decisions

by

the

mentally

ill

revealed

that

most

of

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the patients

advised

to undergo ECT eventually

agreed

to do

so despite

initial objections.

utonomy o

the

mentally ill

The doctrine of

substituted

judgment

was created

to allow

the incompetent individual to exercise vicariously his right of

autonomous decision

making,

but

some

have questioned the

appropriateness of applying the concept of autonomy

to

the

mentally

ill.

Gutheil asks

the

following questions with regard

to autonomy:

Is

the ideal of autonomy fully realized

by the

use of informed

consent?

Are

there times

when

it

should

be

sacrificed for

some

higher good,

such

as safety or rapid

release from confinement? Is

the

mentally ill patient who

refuses

treatment expressing

his autonomy, or is it

rather

his

illness

that

is speaking?

0 Chodoff

believes that a strict

application of informed consent may be

detrimental

to

patient

care, and

that

some degree

of

responsible

paternal-

ism may be desirable.

2°8

The NIMH consensus panel

on

ECT

concluded,

however, that

informed consent

is required

by law and ethics and

that patients'

treatment

decisions

should

be

respected even

though

they might

be

suffering

from a

severe psychiatric

illness that

distorts their

judgment,

so

long as

it

does not

render them legally incompetent.

2

7

9

Effect

o

legal regulation

of E T

Legislative

and judicial regulation

of ECT may be doing

more

harm

than good, according to some observers.

Winslade

et al

21 

studied the

legal

regulation

of ECT in

15 of

the most populous states from

1981 to 1983

and concluded

that

statutes and case law especially

Wyatt

v Hardin

have

impeded

physician

decision making.

Comparing

the

stan-

dards

for ECT recommended by

the

APA

task

force

report

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40

T

on ECT with

those

in federal court orders

and

state

statutes

and regulations,

the

authors

discovered

a

serious boundary

and role confusion due to the

intrusion of state authority into

areas traditionally

reserved

to medical

judgment.1

21

Overreg-

ulation was common,

often

resulting in

the

delay or denial

of

treatment, and

cumbersome legal procedures caused

some

physicians to

abandon attempts

to

use ECT.

A

number

of deaths

have

reportedly

resulted

from delays

in

providing ECT.

212

Simon presented a hypothetical case

of a

patient in danger of dying before permission to administer

ECT could be obtained from

a judge, forcing the psychiatrist

to

choose

between obedience

to the

law and doing

what he

considered

to

be in his

patient's best

interests,

thereby

incurring

the

risk

of

a

lawsuit.

2

13

California had some of the most restrictive

regulations

with

respect

to

ECT even before passage of

the

Berkeley

ordi-

nance,

2

 

4

but

new

regulations

passed in

1985

are

even

more

stringent,

limiting

the

total

number of treatments

that pa-

tients

may

receive defining

any seizure as a treatment

(thereby discouraging the use

of low-level

ECT,

since

shorter

seizures are known to be ineffective), classifying

ECT with

psychosurgery, and

providing that unless two physicians

agree

that

a patient

has

the capacity

to

give

informed consent

to ECT,

a court hearing is required. The statute and

regula-

tions

have

contributed

to the steady decline of ECT in

California, with many hospitals no

longer

offering ECT

because

of

the

red

tape

involved.

215

The need for such

extensive

regulation is called into question

by the results of a survey of the use of ECT

in California

from

1977 to

1983.

About 1.12

persons per 10 000

popula-

tion

received

ECT

each

year, for

a total of 18 627

patients.

Only 3

were

deemed unable

to

consent

and had

court

hearings. The procedure

was quite safe,

with

no fractures

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being

reported, and

a mortality rate

of

0.2

deaths per

10,000

treatments.

Most

E T was paid for

with nonpublic

funds

by

white

patients

in

nongovernmental

facilities.

21

6

A

similar

discrepancy

between the

use of ECT

in public

versus private

patients

has been

observed in Alabama,

where

Wyatt

v ardin

established

stringent

requirements

for the

administration

of

ECT which

are,

however,

not

applied

to

voluntary patients

in

private or

general

hospitals.

7

The

overregulation of

ECT

(and possibly

of

other forms

of

treatment

for

the

mentally

ill, as well

may, it

has been

suggested,

contribute

to

a

two-tiered

system of care

in

which

the

poor, who must

use

public

facilities,

do not have

access

to

all

effective

forms

of

treatment.)

21

8

While

anti-ECT

regulation may

lead

to its

underutilization

in

some

patients,

ECT may

also be

overutilized

in

being used

for

some

disorders

for

which it has not

been proven

effec-

tive.

219

Simon predicts

that

ECT

may

come

to

be

more

widely

used, perhaps

even

for conditions

for

which

it

is not clearly

indicated,

as

diagnosis-related

groups

and prepaid

health

plans

become more

common

to psychiatric

practice, exerting

pressure

to

treat

patients

with

the

most effective

treatments

that produce

the

shortest

hospital

stays.2

°

The right-to-refuse-treatment

cases

were

originally

brought

as

a

means

of

upgrading

care

in

mental institutions,

where

drugs and other

forms

of

therapy

with potentially dangerous

side effects were often

overused

due

to

shortages

of staff and

facilities

for

treatment. 2

It

would

indeed

be

ironic

if

the legal

standards

and

procedures

that

were developed to

raise

the

level

of

care

of the mentally

ill might

now

be used to deprive

some of them

of necessary

care.2

One

author has

written

that ECT

can

be a lifesaving

intervention,

and

its outright

denial

is potentially

more harmful

than its use. -

3

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42

ECT

It

is time to consider whether the

pendulum has

swung too

far

toward excessive emphasis on the

negative aspects

of

organic therapies for the mentally ill. Statutes

and

regula-

tions may not be

flexible

enough to

incorporate new

infor-

mation and provide

for

individualized treatment.

[B]y

their

appearance

of addressing a

problem, such

regulatory ap-

proaches

can divert energy

and resources

from

other

efforts

that might be helpful. 2 The overregulation of

ECT

is

but

one example

of good intentions that may

have been

carried

too far.

Notes

1

American Psychiatric Association

Commission

on

Psychiatric

Therapies,

The PsychiatricTherapies

214 (1984)

[hereinafter

cited

as

APA

Commission].

2. J

Ottosson,

Use and Misuse

of

Electroconvulsive

Treatment, 20

Biological

Psychiatry

933

1985).

3.

H.

Sackeim, Electrode Placement,

Dosing Strategies,

and Out-

come, in Syllabus o

139th

Annual

Meeting 69

APA

1986) [here-

inafter cited as

986 APA Meeting Syllabus].

4.

APA Commission, supranote 1, at 215.

5.

M.

J.

Mills,

D.

T. Pearsall,

J. A. Yesavage

C. Salzman,

Elec-

troconvulsive Therapy

in

Massachusetts, 141

Am. J

Psychiatry

534 (1984).

6.

Several Well-Studied Options Now Available for

Resistant

Depression,

14

ClinicalPsychiatryNews No.

9,

at

6

(1986).

7.

Consensus Conference: Electroconvulsive

Therapy,

254

A.M.A.

2103

(1985) [hereinafter cited as Consensus Confer-

ence ].

8.

Verdict

on

ECT

Mixed

in

NIH

Consensus

Statement,

20

Psychi

atricNews No. 14, at 1 (1985).

9. M. Fink, ECT:

For Whom Is Its

Use

Justified? ,

4

J Clinical

Psychopharmacology303 (1984).

10. Id

11. ECT

Rarely Used in Treating Mentally

Ill

Offenders, 19 Psychi

atricNews No. 3, at

6

(1984).

12. Mills et al., supranote 5.

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13.

S. Levy

E

Albrecht,

"Electroconvulsive

Therapy:

A Survey

of

Use

in

the Private Psychiatric

Hospital," 46

J Clinical

Psychiatry

125

(1985).

See also Mills et

al.,

supra

note

5.

14. Mills

et al. supra note

5.

15.

R. Abrams, "The

ECT Controversy:

Some Observations

and a

Suggestion," Psychiatric

Opinion March 1979, at

16

C.

Holden, "A

Guarded

Endorsement

for

Shock Therapy,"

228

Science

151 (1985).

17.

S

Brakel,

J.

Parry B. Weiner,

The

Mentally

Disabled

and the

Law 330 (3d

ed. 1985).

18.

American

Psychiatric

Association

Task

Force

Report 14: Electro-

convulsive

Therapy (1978)

[hereinafter

cited

as Task Force

Re-

port].

19. J. Smith,

Medical

Malpractice:

Psychiatric

Care

112 (1986).

20.

F.

Varghese

B. Singh,

"Electroconvulsive

Therapy

in 1985-A

Review,

143

Med. J Australia

192 (1985).

21.

R. Abrams

W.

Essman,

Electroconvulsive

Therapy: Biological

Foundations

and Clinical

Applications

8-9 (1982).

22.

R. Crowe, "Electroconvulsive

Therapy-A

Current Perspective,"

311

New Eng.

J

Med. 163

(1984);

P.

G.

Janicak,

J.

M.

Davis,

R.

D.

Gibbons,

S.

Ericksen,

S. Chang P.

Gallagher,

"Efficacy

of

ECT: A

Meta-Analysis," 142

Am. J

Psychiatry

297 (1985).

23.

APA Commission,

supra note

1, at

234.

24. "ECT

Is Primarily

Indicated

for

Endogenous

Depression; Contra-

indications

Are

Unusual,"

13

ClinicalPsychiatry

News

No. 3,

at

3

(1985) [hereinafter

cited

as "ECT Primarily

Indicated"].

25. Crowe,

supra note

22 .

26.

"ECT

Said

to Be Effective

and

Rapidly Active,"

12

Clinical

Psy-

chiatryNews No. 5, at 24 (1984).

27.

APA Commission,

supra

note

1,

at

233.

28.

J. Langone,

"A

New Assault

on

Shock Therapy," Discover

Janu-

ary

1983,

at

54 .

29. "Consensus

Conference,"

supranote 7.

30. I. F.

Small,

V.

Milstein,

M. J. Miller,

F.

NV

Malloy

J.

G. Smal ,

"Electroconvulsive

Treatment-Indications,

Benefits,

and

Limita-

tions,"

40 Am. J

Psychotherapy

343,

354 (1986).

31. C. Von

Valkenburg

P. Clayton,

"Electroconvulsive

Therapy

and

Schizophrenia,"

20

BiologicalPsychiatry

699 (1985).

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ECT

32.

Varghese

. Singh,

supra

note

20 .

33.

Von

Valkenburg

Clayton,

supra

note

31. The

legal

issues with

respect

to tardive dyskinesia

are discussed

in S. Taub,

Tardive

Dyskinesia:

Medical

Facts and

Legal

Fictions,

30 St.

Louis

U.L.J.

833

(1986).

34. W.

Bates

D.

Smeltzer,

Electroconvulsive

Treatment of

Psy-

chotic Self-Injurious

Behavior

in a Patient

With Severe

Mental

Retardation,

139 Am.

J Psychiatry

1355

(1982).

35.

Holden,

supra

note 16.

36.

Ottosson,

supranote

2,

at

942-43.

37. Crowe,

supra note

22;

APA

Commission,

supranote

1 at

217.

38.

Varghese

Singh,

supra note

20 .

39.

Sobel,

Electroshock

Treatment:

Safer

and Quicker

Than

Drugs? ,

New York

Times

December

21,

1979,

at A-16.

40. Crowe,

supra

note

22 .

41.

Consensus

Conference,

supra

note 7.

42.

Loss

of

Memory

After

Electroconvulsive

Therapy, 13

Clinical

Psychiatry

News

No.

4, at

3

(1985);

Varghese

Singh,

supra

note

20; APA

Commission,

supra

note 1,

at

230;

Abrams,

supra

note

15;

R.

Abrams W. Essman,

supra

note

21,

at

180.

43.

Crowe, supra

note

22 .

44. H.

Merskey,

Ethical

Aspects

of the Physical

Manipulation

of

the

Brain,

in Psychiatric

Ethics

135

S. Bloch

P Chodoff

eds.

1981).

45 APA

Commission,

supra

note 1,

at

231.

46.

R. Abrams

W. Essman,

supra note

21, at 181.

47.

Langone,

supra

note

28, at 54 .

48.

Disturbing

Questions

Surrounding

the Use

of

ECT,

13 Clinical

PsychiatricNews

No. 4,

at

37 (1985).

49. Consensus

Conference,

supranote

7.

50

P.

R. Breggin, Electroshock:

Its

Brain-Disabling

Effects

(1979).

For a counter-anecdote,

see the

report

of an 89-year-old

woman,

the

recipient

of

1,250 ECT

treatments

for bipolar

disorder,

whose

brain

showed

no

gross signs

of

damage at

postmortem.

Brain

In-

jury Is Not

Evident

After

1,250

ECT Sessions,

14 Clinical

Psy-

chiatry

News No. 4,

at 31 (1986).

51

Small

et al.,

supranote 30,

at

354.

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52 H.

A Sackeim,

The Case for

ECT,

Psychology

Today

June

1985, at 36;

Consensus Conference,

supra

note

7.

53.

Study

of Electroconvulsive Therapy

on Animals Requested,

131

Med. Devices Reports (CCH)

5

(April 14,

1986).

The

latter

com-

mittee

placed an advertisement

in

The New York

Times

asking

readers

to

write to the

FDA

for

an

investigation of whether

shock

treatment

causes

brain damage.

New York

Times January 9,

1986,

at 50 .

54.

CT

Scan

Study

on

Electroconvulsive

Therapy

Effects Re-

quested,

135

Medical

Devices Rep.

(CCH) 3 (September

24 ,

1986)

[hereinafter cited

as CT Scan Study ].

55

Abrams,

supranote 15.

56 21

U.S.C.

360 (1976).

57

Id

360(e).

58.

M. Boguslaski,

Classification

and Performance

Standards Under

the 1976

Medical Device

Amendments,

40 Food Drug Cosmetic

L J 421, 437

(1985).

59. CT

Scan

Study,

supra note 54 .

60. M. McDonald,

FDA

Orders Tougher

ECT Devices Standards,

14 Psychiatric

News

No.

23, at

1

(1979).

61. C. Nadelson,

Letter,

Consensus

on Electroconvulsive

Therapy,

255

J A.M.A.

2023 (1986).

62.

Statement

on

Electroconvulsive Therapy

Requested

for

Patients,

119

Med. Devices

Rep.

(CCH) 1

(February

18,

1985).

63. APA Commission, supra

note

1,

at

241.

64. For

a

sample

of current research

in

ECT,

see papers

abstracted

in

the 1984

Yearbook of

Psychiatry

and Applied Mental Health

278-

83 (D.

X. Freedman,

J. A. Talbott,

R. S. Lourie, H.

Y. Meltzer,

J. C. Nemiah H.

Weiner

eds.

1984).

65. The

flurry

of

research on

ECT is

reflected

in

a

journal,

Convul-

sive Therapy solely devoted to

that subject.

66.

See, e.g. Sackeim, supra

note 3.

67.

ECT

Dosage

Factors

Critical to

Response, 13

ClinicalPsychia-

try News No.

3, at 1

(1985).

68.

EEG

Suppression

Linked

to

Electroshock Memory

Loss,

14

ClinicalPsychiatry

News

No.

2

at

35 (1986);

C. Welch, Factors

Affecting Generalized

Seizure Activity,

in 1986 P

Meeting

Syllabus

supra

note 3,

at 69.

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  6

T

69

A Miller, R. Faber, J Hatch & H. Alexander,

Factors Affecting

Amnesia,

Seizure Duration,

and

Efficacy

in ECT,

142 Am. J

Psychiatry 692 (1985); S Chang, K. Lebeis,

J.

M.

Silberberg

&

R.

A.

deVito, EEG Seizure

Time and Treatment Response

to

ECT,

in

1986APA

Meeting

Syllabus,

supra note 3, at

259.

70. ECT Primarily

Indicated, supra note

24.

71. Small et

al., supra note 30. The factors found

to

be

related to the

patient's ECT

response were

DSM-III

Axis IV and V, history

of

substance abuse,

and

the

BPRS

withdrawal-retardation

factor.

72.

R.

L.

Horne, H. M. Pettinati,

A.

Sugarman

& E.

Varga, Com-

paring

Bilateral

to

Unilateral Electroconvulsive Therapy in a Ran-

domized Study With

EEG Monitoring, 42

Arch.

Gen. Psychiatry

1087

(1985); R. Weiner, Unilateral Versus

Bilateral ECT: Mini-

mizing

Therapeutic

Differences, in 1986

APA Meeting Syllabus,

supra

note 3,

at 69;

L. Squire, ECT and

Memory Loss, 134

Am.

J Psychiatry 997

(1977);

L. Squire

&

J. Zouzounis,

ECT

and

Memory:

Brief Pulse Versus Sine Wave, 143

Am.

J

Psychia-

try 596

(1986),

Low Sequelae

Risk With Unilateral ECT to Right

Hemisphere, 11

Clinical Psychiatry

News

No.

1,

at

28 (1983);

Varghese

& Singh, supra

note 20;

Janicak et al., supranote 22 .

73.

Ottosson, supra

note 2; R. Abrams

& W.

Essman, supra note

21,

at

50; Crowe, supra note 22;

Janicak et al., supra note 22;

APA

Commission,

supra

note

I,

at

213-42;

R.

Abrams,

Biological

Effects

of

Unilateral and Bilateral ECT,

in

1986

APA Meeting

Syllabus,

supra

note 3, at

68.

74.

H.

Pettinati, K. S. Mathisen,

J.

Rosenbert

& J.

Lynch,

Unilat-

eral

ECT: When

Doesn't It

Work? , in 1986 APA

Meeting

Sylla-

bus, supranote 3, at 68.

75. Horne et

al., supra

note

72;

H.

Pettinati

&

S. Nilsen,

Missed

and Brief Seizures

During ECT: Differential

Response Between

Unilateral

and Bilateral Electrode Placement,

20 Biological

Psychiatry506

(1985).

76.

Task Force Report, supra

note 18.

77. Horne et al., supra

note 72 .

78

Id

79. Task

Force

Report, supra note

18.

80. V. Milstein,

J. G. Small & I. F. Small, Diagnostic

Indications for

Bilateral

ECT, in

1986

APA

Meeting Syllabus, supra

note

at 68.

81.

Sackeim,

supra

note

52 .

82. K. Kesey, One

Flew Over the

Cuckoo sNest

(1964).

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83. C.

Sherman, Former ECT Patients

Urge

That

Procedure

Be

Abandoned,

13

Clinical

Psychiatry

News

No. 3, at 7 (1985).

84.

Sackeim,

supra

note

52, at

36.

85.

P. Janicak, J. Mask,

K. A. Trimakas

& R. Gibbons,

ECT:

An

Assessment

of Mental

Health Professionals'

Knowledge and

Atti-

tudes,

46 J

Clinical

Psychiatry

262

(1985).

86.

See J. Tenenbaum,

ECT

Regulation Reconsidered,

7

Mental

Disability

L.

Rep. 148 (1983).

87.

R. Reisner,

Law and

the

Mental

Health

System 456

(1985).

88.

M.

McCafferty

&

S.

Meyer,

Medical Malpractice:

Bases

o

Liabil-

ity 10.06, 10.22

(1985).

89.

See J. Smith,

supra

note

19,

at

108-22.

90. S.

Brakel et

al., supra

note 17, at 330-31,

349,

458 & 580.

91. R.

Abrams

&

W.

Essman,

supranote

21, at

256.

92. Consensus

Conference,

supra note 7.

93.

NIH Panel Recommends

Restraint

in Use

of ECT, Am. Med.

News

June 28/July 5, 1985,

at 2.

94.

G. Peterson & C. C.

Nadelson,

Letters,

Consensus

on Electro-

convulsive Therapy,

255

J

A.M.A.

2023

(1986);

G.

Peterson,

Letters,

MD

Comments on

ECT

Panel, Am. Med.

News No-

vember

15, 1985,

at

6,

Evaluates

ECT Conference,

13 Clinical

Psychiatry

News

No. 10 at

5

(1985).

95. Nadelson,

supra

note

94.

96.

S.

Brakel

et

al.,

supranote

17, at

580.

97. L.

Lovares,

Claims Manager

for

American

Psychiatric Associa-

tion's

insurance

program, personal

communication.

98.

Annot., 94

A.L.R.3d 317

(1979).

99.

A few cases

alleging

memory

loss are currently

in

litigation.

L.

Lovares,

Claims Manager

for American

Psychiatric

Association's

insurance

program,

personal

communication.

100.

Rice

v.

Nardini,

Docket

No. 78N-1103 (D.C.

1976),

cited in

R.

I.

Simon,

ClinicalPsychiatry

and the

Law

226

(1987).

101. H. W.

Freishtat, Electroconvulsive

Therapy: No

Ban

in

Berke-

ley, 5

J Clinical

Psychopharmacology

52

(1985).

102. I.

N. Perr,

Liability and

Electroshock

Therapy,

25 J Forensic

Sciences 508

(1980).

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  8 ECT

103. d

104.

Farber

v.

Olkon,

254

P2d

520

(Cal.

1953);

Mitchell

v.

Robinson,

334

S.W.2d

(Mo.

1960);

Collins

v.

Hand,

246

A.2d

398

(Pa.

1968).

Farber

reasoned

that

res

ipsa

loquitur

was

inapplicable

be -

cause

ECT

is designed

to

produce

convulsions,

and

fractures

are a

common

hazard

which

occur

even

if

all

due

care

is

used.

105.

Johnston

v.

Rodis,

251

F 2d

917

(D.C.

Cir.

1958).

106.

Woods

v.

Brumlop,

377

P d

520

(N.M.

1962).

107.

Stone

v.

Proctor,

131

S.E.2d

297

(N.C.

1963).

108.

Evans

v.

State

of

New

York,

183

N.Y.S.2d

196

(N.Y.

Ct.

CI.

1958).

109.

Woods

v.

Brumlop,

supra

note

106;

Collins

v.

Hand,

supra

note

104.

110.

Kosberg

v.

Washington

Hospital

Center,

Inc.,

394

F.2d 947

(D.C.

Cir. 1968).

111.

McDonald

v.

Moore,

323

So.

2d

635

(Fla.

Dist.

Ct.

App.

1975).

The

physician

also

allegedly

failed

to

warn

the

patient

of the

risk

of

fractures.

112.

Pettis

v.

State

Department

of Hospitals,

336

So.

2d 521,

526

(La.

Ct. App.

1976).

The

court

said the physician could be

held

negligent,

however,

in

failing

to

determine

whether

the

patient

ex-

perienced

pain

as a

result

of prior

ECT

treatments

before

adminis-

tering

subsequent

treatments,

even

though

he

had

relied

on

nurses

reports

which

failed

to

mention

the

patient s

complaints

of pain.

The

court

also

found

the

nurses

negligent

in

failing

to

inform

the

physicians

of the

patient s

complaints.

113.

R.

Reisner,

supra

note 87,

at

73.

114.

Kapp

v. Ballantine,

402 N.E.2d

463

Mass.

1980).

The

case

against

the

hospital

and

one

physician

was

dismissed,

but evidence

against

the

remaining

physicians

was

held

sufficient

to

raise

a

question

of

liability.

115.

Collins

v.

Hand,

supra

note

104,

at

405-06.

116.

Christy

v. Saliterman,

179

N.W2d

288

(Minn.

1970).

117.

Memory

loss

would

probably

satisfy

the requirement

of

a

physical

injury

if,

as

seems

likely,

it is

caused

by

the physical

effects

of

ECT

on

the

brain.

118.

See

F. A.

Rozovsky,

Consent

to Treatment

A

Practical

Guide

58-

65

1984).

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119. Maben

v.

Rankin, 55

Cal. 2d 139,

10 Cal.

Rptr.

353,

58 P 2d 681

(Cal. 1961).

120. Mitchell

v.

Robinson, supra

note

104.

In both

Mitchell

and

Maben

supranote

119),

the verdict

obtained

by the plaintiff

was

reversed because

of error

in the

jury

instructions.

121. S. Brakel

et al.,

supra note

17, at

458, 357-65.

122.

See

F.

A.

Rozovsky,

supranote 118,

at

70 .

123. Lester

v. Aetna

Casualty

Surety Co.,

240

F 2d

676

(5th

Cir.

1957).

124.

Mitchell

v.

Robinson,

supra

note

104,

at 17.

125.

R.

I.

Simon,

supra note 100,

at

226.

126.

See F. A. Rozovsky,

supra

note 118,

at

61.

127. Mitchell

v. Robinson,

supra

note 104.

128.

Aiken v. Clary,

396

S.W.2d

668,

674-75

(Mo.

1965).

129.

Mitchell v.

Robinson,

supra

note 104.

130.

Wyatt v.

Stickney,

344 F.

Supp.

373

1972).

131.

Wyatt v. Hardin,

Civ. Action

No.

3195-N

(M.D.

Ala.

February

28,

1975), cited

in Mental

Physical

Disability

L.

Rep., July

August

1976, at 55.

132.

J. Parry, "Summary, Analysis,

and

Commentary:

Legal

Parame-

ters

of Informed

Consent Applied

to

Electroconvulsive

Therapy,"

  Mental

Physical

Disability

L. Rep. 162

1985).

133.

239 N.W.2d

905 (Minn.

1976).

134. 375

N.W.2d

526 (Minn. Ct.

App. 1985).

135. New

York

City Health Hospitals

Corp. v.

Stein,

335 N.Y.S.2d

461,

465

1972).

136.

Gundy v. Pauley,

619

S.W.2d

730

Ky.

Ct.

App. 1981).

137.

Ky

Rev.

Stat. 202A.180.

138.

Parry, supra

note 132.

139. Pickle

v.

Curns,

435

N.E.2d

877

Ili. Ct.

App. 1982). Although

the physician allegedly

violated

hospital policy

by administering

ECT without a

muscle relaxant

and

without

first

examining

the

patient, the court

said the hospital

could

not be

held liable unless

the physician were

a hospital employee,

or

the hospital

knew or

should have

known that

the physician

would

violate

its policy.

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5 ECT

140.

706

E d 1456 (7th Cir. 1983), cert. denied 1 6 S. Ct. 822

1986).

The

Court declined

to

rule

on what procedures are

constitution-

ally required before

ECT

can

be

given

to

a

nonconsenting

patient,

saying

only that at

a

minimum

the professional

judgment

stan-

dard announced

by

the

Supreme

Court

of the

United

States in

Romeo

v. Youngberg,

102

S.

Ct.

2452 (1982),

should apply. 106

S.

Ct.

at 1467.

141.

770

F.2d

619 (7th Cir.

1985), cert.

denied

106 S.

Ct.

822 (1986).

142.

601 F Supp.

1297 (D. Ore.

1985).

143. West's

Ann.

Welfare

Inst. Code

5000 5404 1

144.

129 Cal.

Rptr. 535,

57 Cal. App.

3d 662 (Cal. Ct.

App.

1976).

145 129 Cal. Rptr.

at 542.

146.

205 Cal. Rptr.

572 (Cal. Ct.

App.

1984).

147.

Lillian

F. v.

Superior Court,

206 Cal. Rptr. 603,

607

(Cal.

Ct.

App. 1984).

148.

Conservatorship

of

John

Waltz,

San

Diego

Department

of

Social

Services v.

Waltz,

227

Cal.

Rptr. 436, 180 Cal.

App.

3d

722,

181

Cal.

App.

3d

4621

(1986).

149.

Berkeley

Voters

Ban

ECT, Shock

Psychiatric

Profession, 122

ScienceNews

309 (1982);

Freishtat,

supra

note

101.

150. Northern

California

Psychiatric

Society

v. City

of

Berkeley,

223

Cal.

Rptr.

609,

610, 178

Cal.

App.

3d 90 (Cal.

App. Ct. 1986).

151. 223

Cal. Rptr.

at 609, 178 Cal.

App. 3d

at

90. The

other plaintiffs

included

the American

Psychiatric

Association

and the

National

Association

of

Private Psychiatric

Hospitals.

152.

Activists

to

Go

to Calif. High

Court

for

Ban on Use

of ECT,

14

ClinicalPsychiatry

News

No.

6,

at 34

(1986).

153.

Rehearing/review

were

denied May

22, 1986.

154.

Berkeley,

Calif. to Abandon

Efforts

for Ban

on

Use

of

ECT,

14

ClinicalPsychiatry

News No.

10,

at

9 (1986).

155 Vermont

Anti-ECT

Bill Fails, Proponents Vow

Fight,

13 Clini-

cal

Psychiatry

News

No.

5,

at

8 (1985).

156.

See S.

Brakel

et al.,

supra note 17,

at

357-65,

458.

157.

723 P.2d 1103, 106

Wash. 2d

500

(1986).

158.

Wash.

Rev.

Code

71.05.370.

159.

In re

Schuoler,

supra

note 157,

at 1106.

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160. Id

at 1107.

161.

Id

at 1108.

162. Id at 1109.

163. Id t 1111.

164. See

W. J. Winslade, E. H. Liston, J.

W.

Ross

&

K.

D. Weber,

  Medical,

Judicial, and

Statutory

Regulation of

ECT

in

the

United States,

141 Am.

J. Psychiatry 1349 (1984).

165.

See

B.

Hoffman,

The Impact of

New

Ethics

and

Laws

on

Elec-

troconvulsive Therapy, 132 Can. Med.

Assoc.

J 1366

(1985);

Mills

et

al.,

supra

note

5.

166.

See

L. H. Roth, A. Meisel

&

C.

W. Lidz, Tests

of

Competency

to Consent to Treatment,

134 Am.

J Psychiatry 279

(1977);

B. Stanley &

M.

Stanley,

Testing

Competency

in

Psychiatric

Patients,

4 IRB

No.

8,

at

1

(1982).

167. P.

Brown, Psychiatric

Treatment

Refusal,

Patient

Competence,

and Informed Consent,

8

Int l J L. Psychiatry

83

90 (1986);

R.

I. Simon, supranote 100,

at 227.

168.

See

T. Gutheil, The Right to Refuse

Treatment: Paradox, Pendu-

lum and the

Quality

of Care,

4 Behavioral Sciences L.

265,

268 (1986). Stone has called

Kafkaesque the notion that a per-

son may be sufficiently

crazy

to

be

involuntarily committed,

yet

have the right to

refuse the only effective

treatment

available.

A. A.

Stone, Judges

as

Medical

Decision Makers: Is the Cure

Worse

Than the

Disease? ,

33

Cleve. St. L. Rev. 579,

588 (1984-

85).

169. See Stensvad v. Reivitz,

601

F.

Supp. 128

(W.D.

Wis.

1985);

R.A.J. v.

Miller, 590 F.

Supp. 1319 (N.D.

Tex. 1984).

170.

State Laws

Cloud

Definition

of

Psychiatric

Emergency,

21 Psy

chiatricNews No.

21,

at 1

(1986).

171.

See

Gutheil, supra

note

168.

172.

See

Price

v.

Sheppard,

supra

note

133,

at

910-12;

In

re

Alleged

Mental Illness of

Kinzer,

supra

note

134,

at

532;

Lojuk v. Quandt,

supranote 140,

at 1465; In re Schuoler, supra note 157, at 1107.

  Intrusiveness has

also been

used

to

characterize other forms of

psychiatric

treatment,

such

as

antipsychotic drugs.

See

Taub,

supra note 33, at 858.

173.

M. H.

Shapiro,

Legislating the Control of

Behavior

Control:

Autonomy and the Coercive

Use

of

Organic

Therapies,

47

Cal. L. Rev. 237,

256

n.51 (1974).

174.

R. Reisner, supra

note 87, at 461.

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5

ECT

175.

M. H.

Shapiro

&

R.

G

Spece,

Bioethics

andLaw 54

1981).

176.

R.

I. Simon,

supra

note 100,

at

230.

177.

Id.

at

232.

He

might

also

have

cited

the high

frequency

of

sexual

exploitation

of

patients

engaged

in

purely

psychological

forms

of

therapy.

See N.

Gartrell,

J. Herman,

S.

Olarte,

M.

Feldstein

&

R.

Localio,

Psychiatrist-Patient

Sexual

Contact:

Results

of

a

National

Survey,

I:

Prevalence,

143 Am.

J Psychiatry

1126

 1986).

178.

See

Stone,

supra

note

168;

and

Gutheil,

supra

note 168.,

179.

See

Parry,

supra

note

132.

180.

See

Stone,

supra

note 168.

181.

See

H.

Bursztajn,

More

Law and

Less

Protection:

'Critogenesis,'

'Legal

Iatrogenesis,'

and

Medical

Decision-Making,

18

J. Geriatric

Psychiatry

143

1986).

182.

Gutheil,

supra

note 168.

183. Stone,

supra

note 168.

184.

Id. at

591.

185.

Gutheil,

supra

note 168,

at

270-71.

186.

T. Gutheil

&

P.

Appelbaum, The Substituted Judgment Ap-

proach:

Its

Difficulties

and

Paradoxes

in

Mental

Health

Settings,

13

L. Med.

Health

Care

61

1985).

187.

Id.

at

64 .

188.

P.

Chodoff,

Informed

Consent

and

Treatment

Decisions

in

Medi-

cine and

Psychiatry,

in

1986

APA

Meeting

Syllabus

supra

note

3, at

87.

189.

P.R.

Breggin,

supra

note

50,

at

191-92.

190.

Task

Force

Report

supra

note

18.

191.

R.

I. Simon,

supra

note

100, at

222.

192.

Merskey,

supra

note

44.

193.

C.

Culver,

R. Ferrell

&

R.

Green,

ECT

and

Special

Problems

of

Informed

Consent,

137

Am.

J.

Psychiatry

586,

590 1980).

194.

Id.

at 587.

195.

Id

196.

P.

R. Breggin,

supra

note

50,

at

211.

197.

R. Abrams

&

W.

Essman,

supra

note

21, at

254.

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198.

F. A. Rozovsky,

supra

note

118, at

43-49.

199.

See C. Salzman,

ECT and

Ethical

Psychiatry,

134

Am.

J. Psy

chiatry

1006

(1977).

200.

Culver

et al., supra

note 193.

201.

G.

Robinson,

Rethinking

the

Allocation of

Medical

Malpractice

Risks Between

Patients

and Providers,

49 L.

Contemporary

Problems

173, 188

(1979).

202. See

Stanley

&

Stanley, supra

note

166.

203.

See S. Brakel et

al., supra note

17,

at

357-65.

204. See

Merskey, supra

note 44, at 137; Winslade

et al.,

supra note

164.

205. P

Appelbaum & S. Hoge,

The Right to

Refuse Treatment: What

the

Research

Reveals,

4 Behavioral

Sciences L.

279

(1986).

206. C. W. Lidz, A.

Meisel, E. Zerubavel,

M.

Carter,

R. M. Sestak

&

L.

H. Roth,

Informed

Consent

233-34 (1984).

Of the

various

treatments

offered,

the decision

to undergo ECT

involved the

most

participation by

the patient. The

authors suggest

that this

may have been due

to the highly

visible nature

of the treatment,

the fact that patients

were required to sign a consent

form, and

the

physicians'

desire to persuade

other patients

to accept

ECT.

207.

Gutheil, supra

note 168.

208.

Chodoff,

supranote 188.

209. Consensus

Conference,

supra note 7.

210.

Winslade

et al.,

supra

note 164.

211.

Id

t 1349.

212. See B. Kramer, Use

of ECT in California, 1977-1983,

142 Am.

J.

Psychiatry

1190

(1985).

213.

R. I. Simon, supra note 100,

at

216.

214.

A. Scheck,

'Administering ECT

in

California

Won't

Get

Easier,' 13

ClinicalPsychiatry

News

No.

11

at 7

(1985).

215.

Kramer,

supra note 212;

Winslade et al., supra

note

164.

216.

Kramer, supra

note 212.

217.

W. Walter-Ryan,

Letter,

ECT Regulation

and the

Two-Tiered

Care

System, 142 Am. J. Psychiatry661 (1985).

218. Id

219.

Mills et al., supra note 5.

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5

ECT

220.

R.

I. Simon,

supra

note

100

at

220.

221.

A.

Brooks,

Law

and

Antipsychotic

Medications,

4

Behavioral

Sciences

L 247,

253 1986).

222.

Gutheil,

supra

note

168.

223.

S. Brakel

et al.,

supra note

17, at 458.

224.

R.

Baldessarini

B.

Cohen,

Editorial,

Regulation

of

Psychiatric

Practice,

143 Am

J.

Psychiatry

750

1986).