BRIEF OF ANESTHESIA AWARENESS CAMPAIGN, INC.

http://www.oranous.com/florida/MarkSchwab/awareness.htm

http://www.oranous.com/florida/MarkSchwab/AnesthesiaAwarenessCampaign.pdf

No. 07-5439

IN THE

 
 


RALPH BAZE ET AL.,

Petitioners,

v.

JOHN D. REES ET AL.,

Respondents.

On Writ of Certiorari to the

Suprem e Cour t of Ke ntucky

BRIEF OF

ANESTHESIA AWARENESS CAMPAIGN, INC.

AS AMICUS CURIAE

IN SUPPOR T OF N EITH ER PARTY

Richard M. Wyner

Counsel of Record

Sallie F. Pullman

Amanda S. Hitchcock

GOODWIN PROCTER LLP

901 New York Ave., NW

Washington, DC 20001

(202) 346-4000

November 13, 2007 Counsel for Amicus Curiae

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES...................................ii

INTEREST OF AMICUS CURIAE AND

SUMMARY OF ARGUMENT................................1

ARGUMENT ..........................................................2

I. Anesthesia Awareness Is a Real and

Widely-Recognized Medical Complication..................................................................

2

II. Anesthesia Awareness Can Cause

Severe Physical and Psychological Pain. ..... 4

III. Whenever General Anesthesia Is Used,

Measures Can—and Must—Be Taken

To Minimize the Risk of Anesthesia

Awareness. .................................................... 8

CONCLUSION.....................................................12

ii

TABLE OF AUTHORITIES

OTHER AUTHORITIES: Page

American Association of Nurse Anesthetists,

Position Statement 2.12: Unintended

Awareness Under General Anesthesia

(2007), available at http: www.aana.com....... 9–10

American Society of Anesthesiologists Task

Force on Intraoperative Awareness, Practice

Advisory for Intraoperative Awareness

and Brain Function Monitoring, 104

Anesthesiology 847 (2006) .............................. 8–11

Anesthesia Awareness Campaign, Inc.,

Suggestions for Improvement in the

Anesthesia System (2007), available at

http://www.anesthesiaawareness.com/

improvements.html............................................. 10

M.M. Ghoneim, Awareness During Anesthesia,

in Awareness During Anesthesia

(M.M. Ghoneim ed., 2001) ............................ 2–3, 9

Joint Commission on Accreditation of

Healthcare Organizations, Sentinel Event

Alert Issue 32, Preventing, and Managing

the Impact of, Anesthesia Awareness (Oct.

6, 2004), available at http://www.

jointcommission.org/SentinelEvents/Senti

nelEventAlert/sea_32.htm...........................passim

Claes Lennmarken & Gunilla Sydsjo,

Psychological Consequences of Awareness

and Their Treatment, 21 Best Practice &

Research Clinical Anesthesiology 357

(2007)............................................................. 3, 6–7

N. Moerman, B. Bonke, & J. Oosting,

Awareness and Recall During General

Anesthesia: Facts and Feelings, 79

Anesthesiology 454 (1993) .................................... 7

Richard J. Pollard et al., Intraoperative

Awareness in a Regional Medical System:

A Review of Three Years’ Data, 106

Anesthesiology 269 (2007) .......................... 3, 9, 11

Peter S. Sebel et al., The Incidence of Awareness

During Anesthesia: A Multicenter

United States Study, 99 Anesthesia &

Analgesia 833 (2004)............................................. 3

Michael Wang, The Psychological Consequences

of Explicit and Implicit Memories

of Events During Surgery, in Awareness

During Anesthesia 145 (M.M. Ghoneim

ed., 2001) ............................................................... 8

INTEREST OF AMICUS CURIAE AND

SUMMARY OF ARGUMENT1

The Anesthesia Awareness Campaign, Inc. (“AAC”)

is a non-profit organization founded in 1998 that is

dedicated to helping victims, providing education,

and working to prevent anesthesia awareness.

Anesthesia awareness, also called intraoperative

awareness or conscious paralysis, is the phenomenon

of being mentally alert while supposedly under full

general anesthesia. In some instances, victims are

able to feel excruciating pain but are unable to

communicate their awareness because they are

paralyzed by a neuromuscular blocker. The AAC

was founded by Carol Weihrer who, having received

general anesthesia and been paralyzed by a neuromuscular

blocker, was conscious and aware when her

eye was surgically removed.

The AAC’s mission is “to prevent patients (even

one) from experiencing anesthesia awareness and its

consequences through education, prevention, and

empowerment by replacing ignorance or fear with

knowledge.” The AAC’s Board of Directors includes

medical professionals and anesthesiologists as well

as Ms. Weihrer. The AAC has worked with the Joint

Commission on Accreditation of Healthcare Organizations

(“JCAHO”) on raising awareness about this

medical complication. JCAHO consulted with the

1 No counsel for a party authored this brief in whole or in

part, and no counsel or party made a monetary contribution

intended to fund preparation of this brief. No person other

than amicus curiae, its members, or its counsel made a

monetary contribution to its preparation or submission. The

parties have consented to the filing of this brief and their

written consents are being filed today with the Clerk.

2

AAC when drafting JCAHO’s 2004 Sentinel Event

Alert Issue 32 on preventing and managing cases of

anesthesia awareness.

The AAC takes no position on the requirements of

the Eighth Amendment. However, because the execution

protocol at issue in this case carries a risk for

anesthesia awareness, the AAC believes that it is

essential for the Court to be fully informed about

three things. First, anesthesia awareness is a real

and recognized medical complication. Second, when

anesthesia awareness occurs, it can produce severe

physical and psychological pain, particularly when

general anesthesia is combined with a neuromuscular

blocker that prevents patients from communicating

with care providers. Third, the AAC and

the medical community have identified safeguards

that can— indeed, must— be must be employed whenever

general anesthesia is used, in order to minimize

the risk of such devastating consequences. These

safeguards include refraining from the use of neuromuscular

blockers except when absolutely medically

necessary; using reliable monitoring of anesthetic

depth by an anesthesia professional; avoiding

intravenous-only administration of anesthesia; and

having trained anesthesia professionals administer

the general anesthesia. Each of these points is more

fully developed below.

ARGUMENT

I. Anesthesia Awareness Is a Real and

Widely-Recognized Medical Complication.

Anesthesia awareness has been recognized as a

potential medical complication since as early as

3

1846.2 In 1960, the pioneer medical study on the

incidence of awareness under general anesthesia was

published.3 Anesthesia awareness is reported to

occur in between 0.1% and 0.9% of general anesthesia

cases— and those are cases where anesthesia

is typically administered by a trained and licensed

anesthesia professional.4 Thus, at a minimum,

awareness occurs in one out of every one thousand

cases of general anesthesia, equaling some 26,000

occurrences of anesthesia awareness each year in the

United States.5

Anesthesia awareness may occur even where the

patient is not paralyzed by use of a neuromuscular

blocker. For purposes of this brief, however, the

AAC focuses on cases of anesthesia awareness where

patients receive both anesthesia and a neuromuscular

blocker that prevents them from indicating to the

surgical team that they are aware despite the general

anesthesia.

2 See M.M. Ghoneim, Awareness During Anesthesia, in

Awareness During Anesthesia 1, 3 (M.M. Ghoneim ed., 2001).

3 See Claes Lennmarken & Gunilla Sydsjo, Psychological

Consequences of Awareness and Their Treatment, 21 Best Practice

& Research Clinical Anesthesiology 357, 358 (2007).

4 See Richard J. Pollard et al., Intraoperative Awareness in a

Regional Medical System: A Review of Three Years’ Data, 106

Anesthesiology 269, 269 (2007) (summarizing findings from

prior studies).

5 Peter S. Sebel et al., The Incidence of Awareness During

Anesthesia: A Multicenter United States Study, 99 Anesthesia

& Analgesia 833, 836–37 (2004).

4

II. Anesthesia Awareness Can Cause Severe

Physical and Psychological Pain.

AAC’s participants bear personal witness to the

awful physical and psychological injuries that can

arise as a result of anesthesia awareness. They were

rendered unconscious by anesthesia, only to suddenly

find themselves awake and aware but unable to

move or call out for help. They were filled with

anxiety and panic, they felt pain, and they suffered

grievous physical and psychological damage.6

Kathleen LaBrie is an AAC participant who

received general anesthesia and a neuromuscular

blocker for an operation opening both sinus cavities

and a deviated septum. She describes her experience

as follows:

I’ll never forget what happened. I realized something

was very, very wrong when I awoke to the

grinding and pushing in my nose. I also could

hear conversations. I was awake and unable to

let anyone know. I really thought I was slowly

dying and not one person in that room cared. If

anyone wants to know what HELL is like this is

it, what happened to me. This was the most

horrifying, terrifying, nightmare, living hell of

my life. The experience created post-traumatic

stress disorder, outbursts of anger for no reason,

problems with trust, concentration, and

socializing, panic attacks, emotional numbness,

6 AAC President Carol Weihrer testified in the trial in this

case as to her personal experience with anesthesia awareness,

and the transcript of her testimony is set forth in the Joint

Appendix at 387–400. Her testimony is also briefly

summarized in the Petitioners’ Brief at 11.

5

nightmares, and I am easily startled. I have the

feeling of needing to be on guard at all times. It

was the worst thing that ever happened to me,

and I don’t know who I am now. I consider

conscious paralysis worse than death . . . .

AAC participant Kelly Haapala received general

anesthesia and a neuromuscular blocker for a hipsocket

joint replacement after a car accident. Ms.

Haapala’s description of becoming conscious during

surgery is as follows:

Halfway into the surgery, I started to awaken. I

first couldn’t figure out where I was and then as

the drugs wore off more, I realized where I was

. . . I could feel the tugging and pushing on my

left side and slowly the pain began to surface. I

kept telling myself it must be a nightmare but

the pain was so unbearably severe that I began

to worry that my body would not be able to

withstand this stress and pain and that I would

die! It was as if a hot poker was being jammed

into me. . . . I felt like they were killing me and I

needed to do anything I could to move and let

them know I was awake!

I still have nightmares that this happened to me

and even compared to the accident, this is the

worst terror that I’ve ever experienced . . . I have

problems with sleeping, problems with trusting,

feel like I need to try to make every day for my

children and family as good as it can be because I

am so scared that our lives together will be taken

away.

For someone to ever experience conscious

paralysis and be awake during a procedure and

6

feel the pain like I did, it is just worse than death

and is inhumane!

Diana Todd, a participant of AAC who suffered

conscious paralysis during hysterectomy surgery,

offers this account of her experience:

I was awake, aware, paralyzed, utterly terrified,

unable to do anything about it no matter how

hard I tried, and I wished I could die. I remember

thinking, “Take me now, please take me.”

This was the most traumatizing experience of my

life. It takes away your basic humanity. That

kind of terror is cruel beyond description. There

is simply no way to adequately describe what it

is like to have every single scrap of your own self

control stripped away. You can’t even scream to

relieve the pressure.

Amongst the problems in the aftermath of my

trauma, I have nightmares, crippling indecision,

fears, panic attacks, some claustrophobia,

inability to sleep for long periods, sleep restfully,

without a light, or to sleep on a normal schedule,

and I am exhausted all the time.

I consider conscious paralysis to be cruel, dehumanizing,

unnecessary, and unforgivable.

Descriptions of anesthesia awareness in the published

medical literature echo these accounts from

the AAC. It is well recognized that victims of anesthesia

awareness endure “immediate, intraoperative

suffering . . . [and that] long-lasting severe mental

symptoms may develop.”7 Medical studies indicate

that anesthesia awareness can create “great anxiety

7 Lennmarken, supra note 3, at 357.

7

and panic” and terrible sensations of alarm and

fright, including “fears of impending death.,”8 Aware

patients may sense pain, pressure, or other stimuli

associated with the surgical procedure, but, because

of their paralysis, they are unable to notify their

physicians.9

The following are descriptions of several patients’

experiences with anesthesia awareness detailed in

the Moerman study:

Woke up suddenly, feeling intensive pain in

the middle of her chest, tried to move

backwards and scream but was unable to do

so, terrified as if in a nightmare.

Felt intense pain in, and heavy pulling on, her

abdomen, heard voices, could not move, felt

powerless, tried to warn but was unable to do

so, was frightened she might suffer more pain.

Felt and heard being manipulated on his leg,

heard drilling and tightening of screws . . .

tried to warn anyone but was unable to do so

. . . afraid to feel more pain, panicked, thought

he might never get out of it and might become

comatose.

Felt increasing pain until pain was unbearable

. . . wanted to warn anyone but was unable to

do so, unable to talk, powerless.10

8 Id.

9 N. Moerman, B. Bonke, & J. Oosting, Awareness and Recall

During General Anesthesia: Facts and Feelings, 79

Anesthesiology 454, 461–62 (1993).

10 Id. at 460.

8

It is likewise well documented in the medical literature

that the experience of anesthesia awareness

while a patient is paralyzed and unable to communicate

can traumatize a person: “The realization of

consciousness of which operating room staff are

evidently oblivious, along with increasingly frenetic

yet futile attempts to signal with various body parts,

leads rapidly to the conclusion that something has

gone seriously wrong,” and can trigger “shock and

traumatization.”11 This trauma can cause posttraumatic

stress disorder (PTSD) and other serious

psychological consequences such as “recurrent

nightmares related to paralysis, preoccupation with

death, sleep anxiety and initial insomnia.”12 These

acute post-awareness psychological complications

underscore the severity of the actual trauma that

occurs during anesthesia awareness.

III. Whenever General Anesthesia Is Used,

Measures Can—and Must—Be Taken To

Minimize the Risk of Anesthesia Awareness.

In light of the increased awareness of the existence

and the potentially devastating nature of anesthesia

awareness, the JCAHO,13 the American Society of

11 See Michael Wang, The Psychological Consequences of

Explicit and Implicit Memories of Events During Surgery, in

Awareness During Anesthesia 145, 147–48 (M.M. Ghoneim, ed.

2001).

12 Id. at 150.

13 Joint Commission on Accreditation of Healthcare

Organizations, Sentinel Event Alert Issue 32, Preventing, and

Managing the Impact of, Anesthesia Awareness (Oct. 6, 2004),

available at http://www.jointcommission.org/SentinelEvents/

SentinelEventAlert/sea_32.htm [hereinafter JCAHO Alert].

9

Anesthesiologists (“ASA”),14 and the American Association

of Nurse Anesthetists (“AANA”)15 have all

issued practice advisories for the prevention and

management of anesthesia awareness. The AAC

strongly believes that any use of general anesthesia

must be carried out in accordance with medical practices

that can greatly reduce the risk that a person

will suffer anesthesia awareness.

First, when general anesthesia is used, a neuromuscular

blocker should not be used unless doing so

is absolutely medically necessary.16 One advisory

cautions anesthesia professionals to “[a]void muscle

paralysis unless absolutely necessary, and, even

then, avoid total paralysis.”17 In one 2007 medical

study, each confirmed instance of anesthesia awareness

involved the use of a neuromuscular blocker

with general anesthesia.18

Second, a reliable form of anesthesia monitoring

should be used on persons under general anesthesia.

Such monitoring can track indicators of physiologic

14 American Society of Anesthesiologists Task Force on

Intraoperative Awareness, Practice Advisory for Intraoperative

Awareness and Brain Function Monitoring, 104 Anesthesiology

847 (2006) [hereinafter ASA Practice Advisory].

15 American Association of Nurse Anesthetists, Position

Statement 2.12: Unintended Awareness Under General Anesthesia,

available at www.aana.com (follow “Resources: Practice

Documents” hyperlink) [hereinafter AANA Position Statement].

16 See JCAHO Alert, supra note 13; ASA Practice Advisory,

supra note 14, at 850; AANA Position Statement, supra note 15,

Table II; Ghoneim, supra note 2, at 13–14.

17 JCAHO Alert, supra note 13.

18 Pollard et al., supra note 4, at 270.

10

and motor responses to painful stimuli, such as high

blood pressure, fast heart rate, movement, or

hemodynamic changes.19 The ASA recommends

anesthesia monitoring by “multiple modalities” and

cautions that the “use of neuromuscular blocking

drugs may mask purposeful or reflex movements and

adds additional importance to the use of monitoring

methods that assure the adequate delivery of anesthesia.”

20

The AAC believes that brain wave activity monitoring,

in addition to monitoring of physiologic and

motor responses, is a necessary and important part

of monitoring for anesthesia awareness.21 The Food

and Drug Administration has endorsed this view,

finding that an anesthesia professional’s “[u]se of

BIS [a medical device that monitors brain wave

activity] monitoring to help guide anesthetic administration

may be associated with the reduction of the

incidence of awareness with recall in adults during

general anesthesia and sedation.”22

Third, avoiding delivery of general anesthesia

solely by intravenous means can reduce the chance

19 JCAHO Alert, supra note 13; ASA Practice Advisory, supra

note 14, at 851, 854; AANA Position Statement, supra note 15;

Ghoneim, supra note 2, at 17.

20 ASA Practice Advisory, supra note 14, at 854. See also

AANA Position Statement, supra note 15.

21 Anesthesia Awareness Campaign, Inc., Suggestions for

Improvement in the Anesthesia System, available at http://www.

anesthesiaawareness.com/improvements.html.

22 JCAHO Alert, supra note 13.

11

that a person will suffer anesthesia awareness.23

Instead, it is generally recommended that anesthesia

be delivered by both inhalant and intravenous

means.24

Finally, general anesthesia should be administered

only by trained anesthesiology personnel.25 In a

surgical setting, an anesthesia professional administers

the anesthesia and remains at the patient’s

bedside, monitoring real-time indicators to track

anesthetic depth. A trained professional helps

ensure that patients given general anesthesia receive

the appropriate level of medical care to minimize the

risk of conscious paralysis.

In the AAC’s view, these measures must be

employed to minimize the risk that anyone undergoing

general anesthesia will suffer the terrible

physical and psychological injuries associated with

anesthesia awareness.

23 JCAHO Alert, supra note 13; ASA Practice Advisory, supra

note 14, at 850.

24 See JCAHO Alert, supra note 13.

25 See Pollard, supra note 4, at 272 (“Clinical anesthesiologists

supervising registered nurse anesthetists in the anesthesia

care team model of practice delivered all anesthetics in

this study.”). A fully-trained anesthesiologist must fulfill three

years of residency experience, after medical school and a oneyear

internship. A nurse anesthetist must complete a four-year

baccalaureate degree, several years of nursing experience in an

acute care setting, and then a master’s degree of two to three

years.

12

CONCLUSION

The Court’s decision in this case should take into

account that any use of general anesthesia entails a

significant risk of anesthesia awareness, especially

when combined with a neuromuscular blocker; that

the experience of anesthesia awareness is often a

devastatingly painful one, as the accounts from the

AAC’s participants show; and that there are methods

for minimizing the risk of anesthesia awareness that

must be employed in order to avoid the unnecessary

imposition of such injuries on any person undergoing

general anesthesia.

Respectfully submitted,

Richard M. Wyner

Counsel of Record

Sallie F. Pullman

Amanda S. Hitchcock

GOODWIN PROCTER LLP

901 New York Ave., NW

Washington, DC 20001

(202) 346-4000

November 13, 2007 Counsel for Amicus Curiae