Amicus Curiae Brief — Sell v. United States

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No. 02-5664

IN ody ‘

Supreme Court of the Clnited States

On Writ of Certiorari to the

United States Court of Appeals

for the Eighth Circuit

MOTION FOR LEAVE TO FILE BRIEF AND

BRIEF FOR THE AMERICAN PSY CHEATRIC

ASSOCIATION AND AMERICAN ACADEMY OF

PSYCHIATRY AND THE LAW AS 4107 CORTAL

SLPPORTING RESPONDENT

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220 19th Street. \W

Suite SOO

Washington. DC 20036

* Counsel of Record (202) 775-0184

IN THE

Supreme Court of the Anited States

No. 02-5664

Dr. CHARLES THOMAS SELL, DDS,

Petitioner.

V.

UNITED STATES OF AMERICA,

Respondent.

On Writ of Certiorari to the

United States Court of Appeals

for the Eighth Circuit

MOTION FOR LEAVE TO FILE BRIEF FOR

THE AMERICAN PSYCHIATRIC ASSOCIATION

AND THE AMERICAN ACADEMY OF PSYCHIATRY

AND THE LAW AS AMICI CURIAE

SUPPORTING RESPONDENT

The American Psychiatric Association (APA) and the

American Academy of Psychiatry and the Law (AAPL)

respectfully move for leave to file a brief as amici curiae in

this case. Although respondent, the United States, has

granted consent (by letter filed with the Clerk), petitioner

has not.

The APA, with approximately 42,000 members, is the

Nation’s leading organization of physicians specializing in

psychiatry. The APA has participated as amicus in many

cases involving mental-health issues, including Kansas v.

Crane, 532 U.S. 782 (2001), Olmstead v. L.C. by Zimring,

527 U.S. 581 (1999), Kansas v. Hendricks, 521 U.S. 346

(1997), Foucha v. Louisiana, 504 U.S. 71 (1992), Riggins v.

Nevada, 504 U.S. 127 (1992), Washington v. Harper, 494

U.S. 210 (1990), and Addington v. Texas, 441 U.S. 418

(1979). It also participated at the court’s invitation in United

States v. Gomes, 289 F.3d 71 (2d Cir. 2002), involving issues

similar to those presented here.. AAPL, with roughly 2500

psychiatrists dedicated to excellence in practice, teaching, and

research in forensic psychiatry, has participated in, e.g.,

Crane, supra, Penry v. Johnson, 532 U.S. 782 (2001), and

Jaffee v. Redmond, 518 U.S. | (1996).

The members of the APA and AAPL are physicians

engaged in treatment, research, and forensic activities, and

many of their members regularly perform roles in the

criminal justice system. The organizations and their members

have substantial knowledge and experience relevant to the

issues in this case. Both organizations seek to ensure that the

Court has well-grounded facts about antipsychotic

medications, including the new generation of medications

post-dating Riggins, and appreciates the adverse

consequences-for the patient, for other patients at an

institution, for the legal system’s interests-of not giving

medications that are the medically appropriate treatment for

psychotic illnesses and the only realistic hope of restoring

competence.

For these reasons, the APA and AAPL ask that their

motion be granted.

Respectfully submitted.

RICHARD G. TARANTO*

FARR & TARANTO

1220 19th Street, NW

Suite 800

Washington, DC 20036

* Counsel of Record (202) 775-0184

TABLE OF CONTENTS

Page

ae iv

INTEREST OF AMICI CURIAE ........ccccccccccseseseeecseecsees I

a I

LL 2

SUMMARY OF ARGUMENT ...............cccccccccessceseeesees 8

EE ee 9

|. THE LEGAL FRAMEWORK OF RIGGINS V.

NEVADA AND WASHINGTON V. HARPER..... )

ll. THE INTEREST IN RESTORING

COMPETENCE TO STAND TRIAL CAN

JUSTIFY INVOLUNTARY ANTIPSYCHO-

TIC MEDICATION IF IT IS MEDICALLY

EE 11

A. Antipsychotic Medications Are An

Accepted, Often Essential Treatment for

a 13

1. Conventional Antipsychotic Medica-

a Demenanennenen 14

2. The Newer Antipsychotic Medications ... 16

3. Delusional Disorder ........................c0c0000 19

B. The Interests Supporting Medication Are

EEE ee 22

C. First Amendment and Fair Trial Interests

Should Not Alter the Constitutional

lata nts certenentncnecenencncensnsne 25

a 25

Se 27

EEE 30

TABLE OF AUTHORITIES

CASES Pages

Barker v. Wingo, 407 U.S. 514 (1972) ........cccccccees 23

Drope v. Missouri, 420 U.S. 162 (1975)............0+ 29

FDA v. Brown & Williamson Tobacco Corp., 529

OO OO 13

Flanagan v. United States, 465 U.S. 259 (1984)... 23

FTC v. Simeon Management Corp., 532 F.2d 708

I , Fie cctsinccccscconctisiicaseanninsiataitiiaaiiiasiiiiitianiinie 13

Garrett v. United States, 417 U.S. 773 (1985)....... 22

Godinez v. Moran, 509 U.S. 389 (1993)................ 12,29

Graver Tank & Mfg. Co. v. Linde Air Prods. Co.,

OU 19

Gray v. Maryland, 523 U.S. 185 (1998)................ 22

Jackson v. Indiana, 406 U.S. 715 (1972)............... 25

Moran v. Burbine, 475 U.S. 412 (1986) ................ 22

Neil v. Biggers, 409 U.S. 188 (1972) ........cccccccceeees 19

Olmstead v. L.C. by Zimring, 527 U.S. 581

a cccccreneccssnsinaiitannsnisisniesibinianiaintiiaiaieasdiastesliaeaiinidiniiis 23

Pate v. Robinson, 383 U.S. 375 (1966).................. 29

Richardson v. Marsh, 481 U.S. 200 (1987)........... 22

Riggins v. Nevada, 504 U.S. 127 (1992)...........0000 passim

Texas v. Cobb, 532 U.S. 162 (2001)..................... 22

United States v. Gomes, 289 F.3d 71 (2d Cir.

EERE enc er vr ee eo te Nera ee l

United States v. Rutherford, 442 U.S. 544

Ce icricssnieanneartnienaiasituntiaiiiiaiiiainataiiisadibalaaiaidaaiasiaaiiials 13

United States v. O'Brien, 391 U.S. 367 (1968) ..... 27

United States v. Weston, 255 F.3d 873 (D.C. Cir.

5 | a passim

Washington v. Harper, 494 U.S. 210 (1990)....... 9,11, 16

Winston v. Lee, 470 U.S. 753 (1985) ..............000000 22

ill

TABLE OF AUTHORITIES—Continued

OTHER MATERIALS

Sy eITaiiss Sit Se cietisbiiteieteaiceticenbieapnceniiailipeabaiinacain

Si nistnsiontustivatesinsbensenisniguiinenianapnbateinmioemes

Gira Picenpnomemeenunniieneremmtiteninniansiinnenibes

Abroms, Defining Milieu Therapy, 21 Archives

Gen. Psychiatry 553 (1969) .000.......cccccceseeeeeeeee

Amarasingham, Social and Cultural Perspectives

on Medication Refusal, 137 Am. J. Psychiatry

Fe ee iicitcratiemninetienmntneiininioninients

American Psychiatric Association, Brief as

Amicus Curiae in Riggins v. Nevada ............. 10,

American Psychiatric Association, Diagnostic

and Statistical Manual of Mental Disorders,

Pe te cecescmmesnmmn

American Psychiatric Association, Diagnostic

and Statistical Manual of Mental Disorders,

Fourth Edition-Text Revision (2000).................

American Psychiatric Association, Practice

Guideline for the Treatment of Patients With

Schizophrenia, 154 Am. J. Psychiatry No. 4

fg eee

Appelbaum & Gutheil, Rotting With Their Rights

On, 7 Bull. Am. Acad. Psychiatry & L. 306

Baldessarini, Psychopharmacology, in A.

Nicholi, Jr., ed., The Harvard Guide to

Psychiatry (3d €d. 1999) .......ccccccccecsesseeseeseeseeenes

Berg et al., Constructing Competence: Formu-

lating Standards for Legal Competence to

Make Medical Decisions, 48 Rutgers L. Rev.

PE eee nicenansnemmmininicmee

R. Berkow, et al., eds., Merck Manual of Medical

Information, Home Edition (1997) .................+..

24

16, 26

26

17

12

12

IV

TABLE OF AUTHORITIES—Continued

Bonnie, The Competence of Criminal

Defendants: Beyond Dusky and Drope, 47

Miami L. Rev. 539 (1993) .............ccccscccsesscesseees

A. Breier et al., eds., Current Issues in the

Psychopharmacology of — Schizophrenia

Brook et al, Intramuscular Ziprasidone

Compared With Intramuscular Haloperidol in

the Treatment of Acute Psychosis, 61 J.

Clinical Psychiatry 933 (2000) ..............ccccccceeeee

A. Fauci et al., Harrison's Principles of Internal

Medicine (14th ed. 1998) ...............cccccceeeceeeeeeeees

Felthous et al, Are Persecutory Delusions

Amenableto Treatment?, 29 J. Am. Acad.

Psychiatry & L. 461 (2001) 20.0... ccceeeeeeeeeees

Geddes, Prevention of Relapse in Schizophrenia,

346 N.E.J. Moet. SE (2BGZ)....ccccccccccccceeccccscccnsseees

Geddes, Atypical Antipsychotics in the Treatment

of Schizophrenia: Systematic Overview and

Meta-Regression Analysis, 321 British Med.

Bh Gee Ce cieinnniccnnintsnuninnntintiennnitiianimaniniatn

Gervin et al., Spontaneous Abnormal Involuntary

Movements in First-Episode Schizophrenia

and Schizophreniform Disorder: Baseline Rate

in a Group of Patients From an Irish

Catchment Area, 155 Am. J. Psychiatry 1202

J. Gorman, The Essential Guide to Psychiatric

ene 15,

T. Gmnsso et al., MacArthur Competence

Assessment Tool for Treatment (1998)..............

Pages

12

17

19

16, 17

12

Vv

TABLE OF AUTHORITIES—Continued

Pages

Gutheil & Appelbaum, “Mind Control,”

“Synthetic Sanity,” “Artificial Competence, ”

and Genuine Confusion: Legally Relevant

Effects of Antipsychotic Medication, 12

8, ee 26

Kane ef al., Clozapine for the Treatment-

Schizophrenic, 45 Archives Gen. Psychiatry

ee trraresnciinnaiticiapiiandtanntaininainastniieaianainsnine 15

Kane, Treatment of Schizophrenia, 13

Schizophrenia Bull. 133 (1987)... 14

Kane & Malhotra, Clinical Psychopharmacology

of Schizophrenia and Psychotic Disorders, in

G. Gabbard, ed., Treatments of Psychiatric

Cigars (SE CB. TOE) occcececcececsececccsccsecocseses 16,17, 18

Kaye & Reed, Tardive Dyskinesia: Tremors in

Law and Medicine, 27 J. Am. Acad.

oo ea 16, 18, 19

Khot ef al., Not All That Moves Is Tardive

Dyskinesia, 148 Am. J. Psychiatry 661

LE TEAL ALARR See ee ee eRe 19

A. Komaroff, ed., Harvard Medical School

Family Health Guide (1999) .000........cccccccccceeeeees 12

Loebel et al., Duration of Psychosis and

Outcome in First-Episode Schizophrenia, 149

Am. J. Psychiatry 1183 (1992) occ ceeeeeeee 23

Marder, Antipsychotic Medications, in A.

Schatzberg & C. Nemeroff, The American

Psychiatric Press Texthook of

Psychopharmacology (2d ed. 1998) 0.0.0.0... 17

A. Munro, Delusional Disorder: Paranoia and

eo 7, 20-22

vi

TABLE OF AUTHORITIES—Continued

Pages

Opjordsmoen & Retterstol, Outcome _ in

Delusional Disorder in Different Periods of

Time, 26 Psychopathology 90 (1993) ............... 7

Otto et al, Psychometric Properties of the

MacArthur Competence Assessment Tool-

Criminal Adjudication, 10 Psychological

Asssessment 435 (1998) ...........0sscrccsssssrsseseeees 12

Paul, “The New Pharmacotherapy of Schizo-

phrenia,” in A. Breier et al., Current Issues in

the Psychopharmacology of Schizophrenia

Physician's Desk Reference (57th ed. 2003) ......... 4

Pinals & Buckley, Novel Antipsychotic Agents

and Their Implications for Forensic

Psychiatry, 27 J. Am. Acad. Psychiatry & L. 7

ee nctnercnenasemqnesinsvesndnistanarenmensnvindecieniituntonss 19

N. Poythress, et al., Adjudicative Competence:

The MacArthur Studies (2002 ).............cccceeeeeeeees 12

J. Preston, Consumer's Guide to Psychiatric

NS Ge ncnrensenesscersetesntennensemeenneennemesenes 26

J. Preston, J. O'Neal, & M. Talaga, Handbook of

Clinical Psychopharmacology for Therapists

| 10, 17, 23

Rivas-Vazquez ef al., Atypical Antipsychotic

Medications: Pharmacological Profiles and

Psychological Implications, 31 Prof.

Psychology: Res. & Prac. 628 (2000)................ 18

B. Sadock & V. Sadock, Kaplan & Sadock’s

Comprehensive Textbook of @sychiatry (7th

GR, GID cocccccessensssnsenssannenasessanmnenssconnsnneesanenssane passim

vil

TABLE OF AUTHORITIES—Continued

Silva, Effects of Pimozide on the Psycho-

pathology of Delusional Disorder, 22 Prog.

Neuro-Psychopharmacol. & Biol. Psychiatry

er ae iccctnivnisitsntaieatinianrininmmiennsatiacsiaiasiitiaianis

D. Tapley, et al, eds. Columbia University

College of Physicians & Surgeons Complete

Home Medical Guide (3d rev. ed. 1995)...........

U.S. Brief in United States v. Rutherford ..............

P. Weiden, P. Scheifler, R. Diamond, & R. Ross,

Breakthroughs in Antipsychotic Medications

Fis Oe Pencrnsseccessmnmsmesnenmnasensssenennsennmnenenins 10, 14,

Wyatt, Neuroleptics and the Natural Course of

Schizophrenia, 17 Schizophrenia Bull. 325

Pages

17, 19

BRIEF FOR THE AMERICAN PSYCHIATRIC

ASSOCIATION AND THE AMERICAN ACADEMY OF

PSYCHIATRY AND THE LAW AS AMICI CURIAE

SUPPORTING RESPONDENT

INTEREST OF AMICI CURIAE

Amici’s interest is stated in the accompanying motion.

INTRODUCTION

A government can justify involuntary medication to restore

a criminal defendant’s competence to stand trial on several

necessary conditions, most importantly that such medication

is medically appropriate for the individual, i.e., warranted on

the normal medical grounds balancing the benefits of the

medication to the patient against the risks of side effects. The

decisions in United States v. Weston, 255 F.3d 873 (D.C. Cir.

2001), in United States v. Gomes, 289 F.3d 71 (2d Cir. 2002),

and in this case allow involuntary medication to restore

competence for trial on sufficiently serious charges if the

medication is medically appropriate for the individual, it

holds a reasonable prospect of serving its purpose of restoring

competence, and no realistic alternatives holds a similar pros-

pect of achieving that end. This brief supports that standard.”

How the medical aspects of that standard apply in a particular

case is necessarily a case-specific factual question.

The sufficiency of the government’s interest in trying

certain charges ultimately requires a value judgment. Amici

have no distinctive perspective on whether that judgment

' No party authored this brief in whole or in part, and no person except

amici and their members made a monetary contribution to the preparation

or submission of this brief. S. Ct. R. 39.6.

? This case presents no question as to capital punishment, which might

involve special considerations. Nor does the issue before this Court

involve the procedures required for involuntary medication; such

procedures should recognize that delaying treatment (through years of

appeals) can cause not only deterioration in the patient’s condition but

physical changes in the brain that make later treatment more difficult and

less effective.

2

might vary according to the seriousness of the charges and, if

so, what principle might sensibly and workably define any

constitutional line. However drawn, the judgment should

reflect an accurate appreciation of the medical context and the

possible results of refusing medications (e.g., deterioration of

condition, increased difficulty of later treatment, warehousing

of defendants, loss of evidence and ability to try defendants).

STATEMENT

1. Petitioner, a dentist, has a history of mental illness. Pet.

App. 3. He required hospitalization for a psychotic episode in

1982, and he was released following a course of “con-

ventional” antipsychotic medication (haloperidol (Haldol)).

JA242; see JAI51 (second episode: vision of leopard).

In 1997, petitioner was charged with numerous counts of

fraud against Medicaid and against private insurance com-

panies, as well as money laundering. He was initially found

competent to stand trial and released on bond. At a bond-

revocation appearance, he ranted and spat at the magistrate,

and the subsequent bond-revocation hearing included evi-

dence of his deteriorating mental condition. New charges of

conspiring and attempting to kill a witness and an FBI agent

were soon added to the fraud charges. Pet. App. 3, 14. As

trial preparations proceeded, petitioner “filed a notice of

intent to introduce evidence of a mental disease or defect”

(Pet. xii), and his counsel requested a new competency

determination. Petitioner was found incompetent based on a

diagnosis—by both petitioner’s and the government’s psychol-

ogists—of delusional disorder, persecutory type. Pet. App. 3°,

see Pet. App. 36, JA145,149-51 (describing delusions).

> The court of appeals’ opinion (Pet. App. 3 n.3) notes that, under the

standard classification system set forth in the APA’s Diagnostic and

Statistical Manual of Mental Disorders, Fourth Edition [“DSM-IV"| at

296-301 (1994), a delusional disorder is characterized by the presence, for

a month or more, of one or more delusions of a non-bizarre nature, i.e., a

fixed, firm, evidence-resistant, false belief in “generally plausible ideas

that can conceivably occur in real life” (such as being followed, infected,

3

While committed, petitioner was under the care of Dr.

DeMier, a psychologist, with Dr. Wolfson the consulting

psychiatrist. Both determined, and later testified at an

administrative hearing, that antipsychotic medications were

likely to restore petitioner to competency and to be “the only

way he could be restored to competency.” Pet. App. 3. After

petitioner refused medications, a medical hearing officer (a

psychiatrist) “concluded that antipsychotic medication was

the treatment of choice” for his psychotic symptoms. Pet.

App. 4; see JA143-54.

2. At the judicial hearing, Drs. DeMier and Wolfson, on

direct and cross-examination, testified to the following:

e Petitioner has a psychosis. Dr. DeMier had adopted the

diagnosis of delusional disorder, persecutory type, when

petitioner was found incompetent to stand trial. Dr. Wolfson

endorsed that diagnosis tentatively, without yet ruling out

schizophrenia as an alternative diagnosis, indicating that the

appropriate treatment is the same regardless. JA166-68,228-

31,257-60. (Earlier, Drs. DeMier and Wolfson both sug-

gested a possible diagnosis of schizophrenia. JA150.)

e The psychosis, whatever the definitive diagnosis, is best

treated with antipsychotic medication, which is “clearly indi-

cated” as “the only treatment that we could reasonably expect

to improve [petitioner’s] condition,” given the lackof effec-

tive alternatives, the benefits provided, and the recognized but

controllable risks of the medications. JA179; see JA168,180

(no effective alternatives), 187-91 (side effects), 191 (im-

provement unlikely without medication), 220-21 (psycho-

therapy typically not successful with delusional disorder),

deceived by one’s spouse, etc.); lack of visual or auditory hallucinations

(false perceptions) indicative of schizophrenia; and lack of general

impaired functioning and of otherwise obviously bizarre behavior. If the

delusion is of being persecuted, the diagnosis is of “persecutory” type of

delusional disorder. Other types involve delusions about, for example, the

condition of one’s body or erotic attachments. /d The current DSM-/V-

TR at 323-39 (2000) (“TR” for “Text Revision”) is comparable.

4

229-30, 235 (therapy may help after medication, but unlikely

“success or meaningful benefit from other therapy interven-

tions” without medication), 266 (same).

e Without antipsychotic medication, petitioner’s condition

will likely deteriorate, and delayed treatment will likely take

longer to work and not work as well. JA168,231.

e Delusions often respond to antipsychotic medication

(JA218,230,280-81), and petitioner “can be restored to

competency, as a result of treatment with anti-psychotic

medications” (JA179). See JA245 (“good chance”), 300-02

(citing period of a few weeks to months). Dr. DeMier had

two delusional disorder patients who were treated with anti-

psychotic medications, one with haloperidol (Haldol), one of

the older generation, the other with olanzapine (Zyprexa), one

of the newer medications, and saw improvements in both and

restoration of competence in one (the one given Haldol).

JA178-79,187-88. Dr. Wolfson had an 80% success rate on a

somewhat larger group of patients. JA244.

e For delusional disorder, the literature discusses one of the

older medications, pimozide (Orap), as beneficial, but the

newer generation of “atypical” antipsychotics might now be

preferable: they have “substantial advantages,” notably their

“more benign side effect profile” than the conventional

antipsychotics. JA239-41 by

‘Dr. Wolfson mentioned, among the new “atypical” medications,

quetiapine (Seroquel) and olanzapine (Zyprexa), as well as ziprasidone

(Geodon or Zeldox), and observed that, once medication is ordered, it is

reasonable to give patients a choice among appropriate alternatives.

(Flexibility in changing medication, without renewed hearings and delays,

also makes medical sense.) Dr. Wolfson noted, in 1999, that the atypicals

were available only for oral administration, not for injection, so the

atypicals called for patient cooperation. JA241,300-01.

in June 2002, an injectable form of ziprasidone (Geodon) was

approved for marketing in the United States. Physician's Desk Reference

2601 (57" ed. 2003). In Germany, an injectable form of risperidone

(Risperdal), another atypical medication, was approved last summer.

5

e Haldol allowed petitioner’s 1982 release from the hos-

pital; reducing the dose controlled a muscle spasm side-

effect. JA242-43.

e Although “there is a conventional wisdom that patients

with delusional disorder respond less to medication,” Dr.

Wolfson’s experience and the case reports in the literature

actually show favorable results in many cases. JA246.

e There are “some potential unpleasant side effects from

antipsychotic medications,” just as “there are for most medi-

cations that are used in any medical specialty.” JA236. Stiff-

ness and restlessness problems can occur with conventional

(typical, traditional) antipsychotics, but they can be treated;

and possible sedating effects can likewise be dealt with.

JA236-37. “[MJost patents don’t have to expect problematic

side effects as the cost of having their illness treated and

having control of their own thoughts and minds.” JA237. As

for the potentially serious neuroleptic malignant syndrome,

the risk is very small, perhaps | in 10,000, and the costs of

the continuing illness are much greater. JA238-39.

Petitioner submitted a declaration by Dr. Cloninger, a

psychiatrist, recommending against medication. Noting that

delusional disorder “is a rare condition,” unlike schizo-

phrenia, so that psychiatric experience is limited (JA30), he

distinguished medication’s effectiveness for schizophrenia

and its effectiveness for delusional disorder. After citing a

1988 textbook, he reported finding only one article containing

“systematic data * * * about the treatment of a large series of

cases of Delusional Disorder,” a 1993 article reporting “‘a

long-term follow up study’” of 72 Norwegian patients,

comparing the long-term results of a group first admitted to

hospitals in 1946-1948 (before antipsychotics were intro-

duced) to a group first admitted in 1958-61 (after the earliest

antipsychotics were introduced), and finding no “more

favorable outcome” for the latter group. JA30-31. “In other

words, there is no evidence that neuroleptics are beneficial for

patienis with Delusional Disorder.” JA31; see JA31-32.

6

Dr. Cloninger, noting petitioner's 1982 treatment with

antipsychotic medication, stated that petitioner’s “delusions

did not respond as evidenced by his immediately discon-

tinuing treatment” and that petitioner “regarded that treatment

as a terrible experience.” JA32.° Neuroleptics “always are

associated with risk of side effects,” and “treatments that

carry any risk at all” should not be given involuntarily, he

wrote, “in the absence of documented evidence of benefit to

the person.” JA32. He therefore recommended “treatment

* * * limited to basic support and voluntary symptomatic

treatment,” including “‘a safe supportive milieu with access to

exercise and reading material” and voluntary antidepressant

medication (paroxetine (Paxil)). JA32; see JA149,294. Dr.

Cloninger did not testify and so was not cross-examined.

Dr. Wolfson responded to Dr. Cloninger’s brief declara-

tion, criticizing its broad conclusions. The absence of large

scale, double blind, placebo control studies—which are

impractical with delusional disorder (particularly paranoid)

patients—does not support a conclusion that medications are

ineffective; and case reports and a statistical analysis of prior

studies in fact show significant beneficial response.

JA247-49,278-79. Moreover, the 1993 article cited by Dr.

Cloninger does not show ineffectiveness. It reports only

certain long-term results (not short-term effectiveness), based

on two groups of patients from the era when only the very

first antipsychotic medications were available; the article

reserves judgment on how informative even as to long-term

* Dr. Cloninger did not address the apparent effectiveness of medi-

cation in allowing petitioner’s release from the hospital in 1982 and did

not explain why ineffectiveness was shown by petitioner’s discontinuance

of medication. Patients stop medications for other common reasons: ¢.g.,

the medications did their job and are no longer needed; a patient believes

the medications are no longer needed or (as with delusional disorder) does

not consider himself ill or dislikes side effects. The article cited by Dr.

Cloninger recognizes the frequency of “noncompliance” (not taking pre-

scribed medication) with delusional disorder patients. See note 6, infra.

;

resuits the lack of difference between the groups is, noting

that delusional disorder patients often do not take their medi-

cations over time; and the article notes reports of pimozide’s

benefits for delusional disorder. JA248-50,278-79.°

3. The magistrate (like the medical hearing officer

previously) found that, with side effects subject to control, the

medical benefits of antipsychotic medication far outweigh any

risk, such medication was likely to restore competence (enable

petitioner to communicate rationally with counsel), and there

were no realistic alternatives. Pet. App. 24-26. The district

court, noting the ability to control risks of side effects, found

that the record supports the same findings and, hence, the order

of medication, also noting the prematurity of concerns about

any adverse effects from medications on trial rights. /d. at 29-

46. The Eighth Circuit drew the same conclusions (id. at 7-

10), basing the judgment only on the fraud and money-

laundering charges. Pet. App. 7.’

* The limited significance of the 1993 article for the question of

relevance here—short-term effectiveness of any of the whole range of

antipsychotic medications now available, including the 1990s generation—

is evident in the article itself. Opjordsmoen & Retterstol, Outcome in

Delusional Disorder in Different Periods of Time, 26 Psychopathology 90

(1993); JAI35-43. The paper notes that “pimozide has * * * been

reported to be beneficial” for delusional disorder patients. /d at 90. The

paper observes that such patients are “often difficult to treat because of

denial, projection and reluctance to take drugs” (id) and that, while

delusional disorder might be more resistant to treatment than schizo-

phreni. “[a)nother explanation might be that there are more problems

with compliance [patients’ actually taking their medication] in delusional

disorder than in schizophrenia,” for “[pjaranoid patients are usually very

sensitive to all side effects of drugs.” /d at 93. The paper notes “the

difficulties encountered in doing research in this field,” so treatment for

this disorder “still seems to be terra incognita, and controlled drug trials

are strongly needed.” /d; see also A. Munro, Delusional Disorder:

Paranoia and Related Ilinesses 229 (1999) (“noncompliance with

psychiatric treatment is a common feature of delusional disorder”).

” In disregarding the other charges (attempt and conspiracy to commit

murder), the court merely said: “It is possible that [petitioner's] threats

SUMMARY OF ARGUMENT

The similar analyses of the Eighth, Second, and D.C.

Circuits skould be followed by this Court. Criminal

defendants, like others, have an undoubted liberty interest in

avoiding forced bodily intrusions, including any kind of

medication, psychiatric or otherwise. But the interest is not

absolute, and just as avoiding danger to self or others suffices

to justify medically appropr'a*e medication, so should the

government interest in restoring competence to stand trial (on

charges this Court deems sufficiently serious). There are

weighty interests in resolving criminal charges and in

avoiding the harmful effects of leaving individuals without

needed treatment. The crucial conditions are that the medi-

cation be medically appropriate, under the normal medical

balancing of benefits and risks (taking account of the

manageability of risks); hold a reasonable prospect of

restoring competence; and be reasonably necessary to achieve

the goal, considering alternatives.

The analysis should be the same whether the needed

medication is a psychiatric or nonpsychiatric one. Whether

particular medications meet the crucial conditions in a

particular case is a matter for case-specific determination

based on medical judgments. Those judgments take account

of the particular illness at issue and whatever likelihood there

is of side effects from the typically short-term use of

medications needed for the goal of competence restoration.

after his first indictment were a manifestation of his delusional disorder

***” Pet. App. 7.8. That rationale for ignoring the murder-reiated

charges is unrelated to the interests justifying medication (adjudicating

charges). Moreover, that rationale might bar involuntary medication in

any insanity-defense case, no matter how serious (ne offense. If a

defendant charged with actua/ murder claimed insanity based on a mental

illness that also makes him incompetent, it could equally be said that “[i}t

is possible that [the murder was] a manifestation of his [insanity].”

Petitioner himself has raised a mental-illness defense, so even the fraud

and moneylaundering might be “a manifestation of” his mental illness.

9

In particular, they take account of the significant advances in

antipsychotic medications post-dating this Court’s decisions

in Riggins v. Nevada, 504 U.S. 127 (1992), and Washington

v. Harper, 494 U.S. 210 (1990), including the new generation

of antipsychotic medications that, as a class, have better side-

effect profiles than the earlier medications.

Neither First Amendment interests nor Sixth Amendment

trial-right interests should alter the basic judgment about

justifying involuntary administration of medically appropriate

medication. Such medication typically enhances rather than

impairs speech interests, and, in any event, the government

justification sufficient for due process analysis would suffice

under the First Amendment as well. Likewise, appropriate

medication typically enhances rather than impairs a

defendant’s ability to participate effectively at trial, and, in

any event, any concerns about possible sedating or other

adverse effects on demeanor or testifying ability are properly

considered at a later stage, after competence is restored. The

defendant may plead guilty and avoid trial; adverse effects

often will not occur at all; and any adverse effects are broadly

subject to being controlled by adjustment of medication, so

the mere possibility of such effects should not stand in the

way of restoring competence.

ARGUMENT

I. THE LEGAL FRAMEWORK OF RIGGINS V.

NEVADA AND WASHINGTON V. HARPER

Based on the longstanding legal recognition of personal

autonomy, there is a due process liberty interest in refusing

unwanted antipsychotic medication, like any other medi-

cation, but the interest “is not absolute.” Weston, 255 F.3d at

876; see Riggins, 504 U.S. at 135; Harper, 494 U.S. at 220,

222-23. Harper and Riggins illustrate the two sides of that

principle. Harper establishes the sufficiency, for justifying

involuntary medication, of the state interest in avoiding dan-

ger in a custodial setting, where the medication is medially

appropriate. Riggins recognizes the constitutional interest

10

itself by holding, as argued by the APA, that the State must

justify involuntary medication, which the State had not been

required to do in Riggins at all. Riggins, 504 U.S. at 136.

Riggins makes clear, too, that this principle is properly

enforced in the criminal proceeding itself, rather than in a

collateral suit challenging unjustified involuntary medication.

It was on that question—a point of disagreement with the

dissent (Riggins, 504 U.S. at 146 (Thomas, J., dissenting))-

that it was relevant for the Riggins Court (and the APA) to

observe that certain medications, especially if given in high

doses, may affect a criminal defendant’s appearance, and role,

as a criminal defendant. See APA Riggins Br. 12-15;

Riggins, 504 U.S. at 137; id. at 142-43 (Kennedy, J.,

concurring in the judgment) (quoting APA brief).* Indeed,

Riggins had been given very high doses of thioridazine

(Mellaril), a conventional antipsychotic medication with

significant sedating effects that many other medications, both

older and newer ones, do not have. /d. at 137.” Such

* Possible side effects, differing even among the conventional medi-

cations, include restlessness, “parkinsonism” (characterized by tremors or

diminished range of facial expression or slowed movements or speech),

and sedation. “There is, however, little reliable evidence that properly

used antipsychotic medication has any significant adverse effect on

attention or perception. And it is well established that the foregoing side-

effects are readily subject to reversal or control by adjusting doses or

prescribing counteracting medication.” APA Riggins Br. 10-11 (citations

omitted).

* See, e.g., J. Preston, J. O’Neal, & M. Talaga, Handbook of Clinical

Psychopharmacology for Therapists 178-79 (2d ed. 2001) (tables listing

medications, dosages, and side effects); P. Weiden, P. Scheifler, R.

Diamond, & R. Ross, Breakthroughs in Antipsychotic Medications

94 (1999) (publication of National Alliance for the Mentally III) (table of

conventional medications and side effects); id at 111 (noting differences

in sedating effects even among various older medications, let alone among

end after a few weeks; “[s]edation is very sensitive to dose adjustments”).

The dosage of Mellaril given to Riggins was 800 mg, the very highest

indicated dose. Riggins, 504 U.S. at 129, 131.

potential side effects, being relevant to the criminal trial,

justify a demand for state justification in the criminal case.

This point must not be overstated. The Court did not

decide, and the APA did not urge, that such potential effects

defeat a State interest in restoring competence or that they

even weigh heavily, given that side effects are broadly subject

to being monitored and controlled, whether by switching

medications, lowering doses, or taking other action. All

Riggins decided was that (a) a criminal defendant may insist,

in the criminal case, on the State justifying involuntary

(medically appropriate) medication and (b) dangerousness in

custody is sufficient justification (Riggins, 504 U.S. at 135;

Harper, 494 U.S. at 225-26), while the need to restore

competence “might” be (Riggins, 504 U.S. at 136). And the

entire consideration of antipsychotic medications in Riggins,

as in Harper, was in a medical context now dramatically

altered: a new generation of medications has, since 1990,

transformed practices in the treatment of psychotic illnesses.

Il. THE INTEREST IN RESTORING COMPET-

ENCE TO STAND TRIAL CAN JUSTIFY

INVOLUNTARY ANTIPSYCHOTIC MEDICA-

TION IF IT IS MEDICALLY APPROPRIATE

Antipsychotic medication should be treated like other

medication. Because an individual has a constitutional

interest in avoiding any involuntary bodily intrusion, a

justification is required to administer any type of medication

to an objecting individual, including one who is incompetent

to stand irial. The medical, and legal, judgment should be

similar whether, for example, antithyroid medications (with

their side-effect risks) are being considered for a thyroid

condition like Grave’s disease (see A. Fauci et al., Harrison's

Principles oj Internal Medicine 2026-27 (14th ed. 1998)) or

an antipsychotic medication (with its particular side-effect

risks) is being considered for a mental illness. In each case,

the individual’s side of the constitutional balance is protected

by the essential requirement of medical appropriateness of the

12

particular medication for the individual, considering the

treatment benefits and risks. On the other side of the balance,

the public interest at issue here (adjudicating serious criminal

-charges) is a great one; and that interest typically is

accompanied by additional interests as well.'°

In undertaking the analysis, it is critical to bear in mind

that virtually all medications, whether psychiatric or non-

psychiatric, involve risks of side effects.'’ This commonplace

' Amici here assume that petitioner's refusal of medication was a

competent one. Incompetence to stand trial, involving inabilities to

understand proceedings or assist in one’s defense (Godinez v. Moran, 509

U.S. 389 (1993)), is conceptually and practically distinct from competence

to make a rational choice about medication. See T. Grisso ef al,

MacArthur Competence Assessment Tool for Treatment (1998), Otto et

al., Psychometric Properties of the MacArthur Competence Assessment

Tool-Criminal Adjudication, \0 Psychological Asssessment 435 (1998);

Berg et al., Constructing Competence: Formulating Standards for Legal

Competence to Make Medical Decisions, 48 Rutgers L. Rev. 345 (1996),

Bonnie, The Competence of Criminal Defendants: Beyond Dusky and

Drope, 47 Miami L. Rev. 539 (1993); N. Poythress, ef al., Adjudicative

Competence: The MacArthur Studies (2002). For an individual who is

incompetent to refuse treatment (as well as to stand trial), autonomy

The question here assumes no such special weakening of autonomy

interests and addresses the State’s interest in restoring competence to

stand trial, not other state interests, as justification for involuntary

"' See, e.g, A. Komaroff, ed., Harvard Medical School Family Health

Guide 1151 (1999) (“Every medication, including nonprescription drugs,

has the potential to cause side effects or adverse reactions.”); D. Tapley, ef

al., eds. Columbia University College of Physicians & Surgeons Complete

Home Medical Guide 836 (3d rev. ed. 1995) (“All drugs—even aspirin-can

have unpleasant side effects in some people.”); R. Berkow, ef al., eds.,

Merck Manual of Medical Information, Home Edition 26 (1997) (“Most

drugs * * * have some undesired effects.”; “Since all drugs can harm as

well as help, safety is relative. The wider the margin of safety

(therapeutic window)-the spread between the usual effective dose and a

dose that produces severe or life-threatening side effects-the more useful

the drug.”; “Some drugs must be used despite their having a very narrow

13

fact is recognized, for example, in the longstanding law

governing drug approval, under which “safety” itself is

always a balancing of benefits and risk. FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 142 (2000)

(“virtually every drug or device poses dangers under certain

conditions”); id. at 140 (“safety” under FDCA means that a

drug’s or device’s “probable therapeutic benefits must out-

weigh its risk of harm”).'? Medical decisions always involve

balancing such risks against the benefits of the medication in

(a) relieving suffering and (b) improving functioning. See

Weston, 255 F.3d at 876-77 (medical appropriateness, as

judged by professionals, is measured “by examining the

capacity of antipsychotic drugs to alleviate [the individual’s]

schizophrenia (the medical benefits) against their capacity to

produce harm (the medical costs, or side effects)”). That

balance is part of the medical appropriateness determination

itself, as the testimony and findings here confirm, whether the

subject is antipsychotic medication for a mental illness or

nonpsychiatric medication for a non-mental illness.

A. Antipsychotic Medications Are An Accepted,

Often Essential Treatment for Many Psychoses

Antipsychotic medications are not only an accepted but

often essential, irreplaceable treatment for psychotic illnesses,

margin of safety.”; examples are anticlotting drug, warfarin, and

i ic drug, clozapine).

" Id. at 142 (“drugs are safe within the meaning of the Act because, for

certain patients, the therapeutic benefits outweigh the risk of harm”),

United States v. Rutherford, 442 U.S. 544, 556 (1979) (safety means that

the “potential for inflicting death or physical injury is not offset by the

possibility of therapeutic benefit”); FTC v. Simeon Management Corp.,

532 F.2d 708, 714 (9th Cir. 1976) (per Kennedy, J.) (“many risky medical

procedures may be regarded by the FDA as ‘safe,’ in light of their greater

potential benefits.”); U.S. Brief in Rutherford at 31-32 (“A drug is ‘safe,’

within the meaning of the Act, if the benefits expected to be achieved

through its administration outweigh the costs or risks incurred. No drug is

completely ‘safe’ in the lay person’s sense of the word, since every

drug—aspirin not excepted—involves risks.”) (footnotes omitted).

14

- as most firmly established for schizophrenia, because the

benefits of antipsychotic medications for patients with

psychoses, compared to any other available means of

treatment, are so palpably great compared with their generally

manageable side effects. See Weston, 255 F.3d at 877 n.2.

That was so for the antipsychotic medications prevalent in

1990: e.g., haloperidol (Haldol), thiothixene (Navane),

chlorpromazine (Thorazine), thioridazine (Mellaril), or

pimozide (Orap). See B. Sadock & V. Sadock, Kaplan &

Sadock’'s Comprehensive Textbook of Psychiatry ch. 31.17 at

2356-77 (7th ed. 2000) [“Textbook”’] (“Dopamine Receptor

Antagonists (Typical Antipsychotics)”). It remains true with

the post-Riggins generation of antipsychotic medications,

which, while each carrying its own combination of side-effect

risks (like virtually every drug), have lower risks of the older

drugs’ more troublesome side effects. The newer drugs

include risperidone (Risperdal), olanzapine (Zyprexa),

quetiapine (Seroquel), and ziprasidone (Geodon (elsewhere,

Zeldox)). See Breakthroughs in Antipsychotic Medications at

94-95; Textbook ch. 31.26 at 2455-74 (“Serotonin-Dopamine

Antagonists”). '°

1. Conventional Antipsychotic Medications. Even at the

time of Riggins, before the atypicals, antipsychotic drugs

were central to treating both acute and chronic psychoses

such as schizophrenia. In 1987, the National Institute of

Mental Health concluded that such drugs “remain the primary

modality in the treatment of an acute episode or an acute

exacertation of a schizophrenic illness,” having “a dramatic

effect on the symptoms of schizophrenia (e.g., delusions,

hallucinations, and thought disorder) within 4-6 weeks,

although improvement may continue well after that interval.”

Kane, Treatment of Schizophrenia, 13 Schizophrenia Bull.

'’ As the Textbook chapter titles show, the older medications worked

principally through their effect on dopamine, one of the neurotransmitter

amino acids, while both dopamine and serotonin (another neurotransmitter

amino acid) are affected by the newer generation.

15

133, 134, 142 (1987). The drugs were similarly central to

long-term treatment of chronic psychosis, being “of enormous

value in reducing the risk of relapse and_ rehos-

pitalization.” /d. at 143. Medication was commonly essen-

tial: “The available data do not support the feasibility of

substituting any psychotherapeutic strategy for drug treatment

on an indefinite basis.” /d. at 142; see Kane et al., Clozapine

for the Treatment-Resistant Schizophrenic, 45 Archives Gen.

Psychiatry 789 (1988) (earliest of newer medications).

That accepted standard of care, even in 1990, fully

accounted for side effects, reflecting the devastating character

of the illnesses being treated.'* This Court reviewed some of

the side effects of the older antipsychotic medications in

'' See Paul, “The New Pharmacotherapy of Schizophrenia,” in A.

Breier et «/., Current Issues in the Psychopharmacology of Schizophrenia

xvii-xviii (2001) (schizophrenia afflicts '2-1% of the world’s population,

“is associated with a high degree of morbidity and mortality” (including a

10% suicide rate), and “the illness almost invariably requires

institutionalization and both acute and chronic intervention (at great

emotional and financial expense), “ but “effective pharmacotherapy is

available for most patients with this disorder”); J. Gorman, The Essential

Guide to Psychiatric Drugs 197-98 (3d ed. 1997) (“there is no debate that

schizophrenia is a horrible illness. It strikes people in late adolescence to

early adulthood and often never goes away. * * * [Most] endure many

hospitalizations, are unable to work, and have little social interaction.

Schizophrenia devastates the early adult years of most patients. The situ-

ation is almost equally grim for families * * *. Living with a [person with

schizophrenia] is usually a full-time and harrowing job. The patient lives

in his or her own world, entertaining bizarre ideas and listening to voices.

He may talk without making sense, pace the floors all night, and occa-

sionally become violent or threatening. Parents, acting as if they have

toddlers, are afraid to leave their [children with schizophrenia] alone.

They, like the patient, become prisoners of the illness. So, although

schizophrenia may seem romantic or interesting to philosophers, it is

plainly awful to its victims. * * * The hallmarks of schizophrenia are

hallucinations, delusions, thought disorder, and disorganized behavior.

These[] are often called positive symptoms. There are also negative

symptoms such as abnormal affect, loss of motivation, and social

isolation.”).

16

Harper, 494 U.S. at 229-30 (describing acute dystonia;

akathisia; neuroleptic malignant syndrome; and _ tardive

dyskinesia); see Riggins, 504 U.S. at 134. But it was true

even in 1990 that “[mJost of th[e] side-effects *** may be

controlled by lowering dosages or by adding another medi-

cation; such side effects ordinarily cease when antipsychotics

are discontinued.” APA Riggins Br. 10 (footnote on tardive

dyskinesia omitted); see Weston, 255 F.3d at 877 (“While

there are potential side effects, the professional judgment of

the medical experts was that ‘each of these potential side

effects is generally manageable.””); note 9, supra (even

among conventional medications, wide variation in sedating

effects). With respect to tardive dyskinesia, two facts are

especially significant for short-term treatment of most

psychoses: first, “[a]lthough the risk of TD is frightening and

serious, so is the risk of allowing acute psychosis to remain

uncorrected” (Essential Guide to Psychiatric Drugs at 219);

second, “TD virtually never develops after only a few weeks

or months of taking the antipsychotic drugs.” /d.'*

2. The Newer Antipsychotic Medications. The medical

context “has changed substantially during the 1990s.” Text-

book at 1199. With the newer medications, it is all ‘he more

firmly true that medications are commonly essential to

“ Tardive dyskinesia appears to develop at rate of “about four percent

per year of cumulative drug exposure for at least the first five years” with

the older medications. Kaye & Reed, Tardive Dyskinesia: Tremors in

Law and Medicine, 27 J. Am. Acad. Psychiatry & L. 315, 315 (1999); see

Kane & Malhotra, Clinical Psychopharmacology of Schizophrenia and

Psychotic Disorders, in G. Gabbard, ed.. Treatments of Psychiatric

Disorders 1027. 1038 (3d ed. 2001) (“Prospective studies have suggested

an incidence of 5% per year of antipsychotic exposure in young adults,

with a substantially higher incidence in elderly persons. The majority of

cases are mild and not necessarily progressive even with continued

antipsychotic exposure. However, some patients develop a severe and

disabling form of the condition. If medication can be discontinued, the

prognosis is often favorable, but discontinuation is often not feasible.”).

17

responsible treatment of psychoses like schizophrenia.'° The

newer “atypical” antipsychotic drugs not only have proved

effective for many people (including some for whom typicals

did not work well) but are widely recognized to “have a

‘more favorable side effect profile’” as a class than the older

medications, as the testimony in Weston established and Dr.

Wolfson’s testimony in this case reiterates. See Weston, 255

F.3d at 877 n.3 (noting side effects as a class; importantly,

amici note, side effects differ even among the atypicals).

It is important to avoid generalizations that either over-

simplify or get ahead of the ever-continuing research on

particular medications.'’ Nevertheless, it is clear that major

'© See also Kane & Malhotra, supra, at 1027-28 (“Pharmacological

treatment is a critical component in the short- and long-term management

of schizophrenia.”); Handbook of Clinical Psychopharmacology for

Therapists at 177 (“Antipsychotic medications have truly revolutionized

the treatment of psychotic disorders. Their effectiveness is so vastly

superior to previous treatments that they have ushered in a new era in the

treatment of severe mental illnesses.”); Baldessarini, Psychophar-macol-

ogy, in A. Nicholi, Jr., ed., The Harvard Guide to Psychiatry 444, 450 (3d

ed. 1999) (effectiveness within a few days or weeks; “acute psychosis or

exacerbations of chronic psychosis, especially of schizophrenia, are

routinely treated with antipsychotic medications in adequate doses”);

Marder, Antipsychotic Medications, in A. Schatzberg & C. Nemeroff, The

American Psychiatric Press Textbook of Psychopharmacology 309 (2d ed.

1998) (“these drugs have become standard treatments in psychiatry and

medicine”); Geddes, Prevention of Relapse in Schizophrenia, 346 N.E.J.

Med. 56 (2002) (“the preponderance of the evidence now supports the use

of risperidone as a first-line treatment for patients with schizophrenia,

both to induce remission and to prevent relapse”). (The last-cited article

updates Geddes, Atypical Antipsychotics in the Treatment of Schizo-

phrenia: Systematic Overview and Meta-Regression Analysis, 321 British

Med. J. 1371, 1375 (2000) (atypicals and typicals comparably effective

and tolerable overall; atypicals cause fewer “extrapyramidal” side effects;

recommending use of typicals first).)

'? Sources describing particular drugs and what is known about them,

including their own risks of side effects, include the Textbook sections

cited above; The Essential Guide to Psychiatric Drugs, supra, Break-

throughs in Antipsychotic Medications, supra, A. Breier et al., eds.,

18

progress has been made, particularly in reducing the tradition-

ally most troublesome side effects (and also in helping previ-

ously hard-to-treat psychoses), by the introduction of the

newer atypical medications in the last decade. See Weston,

255 F.3d at 886 n.7 (“Antipsychotic drugs have progressed

since Justice Kennedy discussed their side effects in Riggins.

There is a new generation of medications having better side

effect profiles.”). Each such medication, like any medication,

has its own side-effect risks: for example, for some of them, a

risk of weight gain and, from long-term use, a risk of dia-

betes. But the side-effect profiles are significantly improved

from the older generation, and the improvements include

what strongly appears, from an accumulating body of evi-

dence, to be a substantial reduction of the risk of tardive

dyskinesia.'* As one paper noted, because of the lower risks

Current Issues in the Psychopharmacology of Schizophrenia (2001); and

the APA’s Practice Guideline for the Treatment of Patients With Schizo-

phrenia, 154 Am. J. Psychiatry No. 4 (April 1997 Supp.); see also

Rivas-Vazquez ef al., Atypical Antipsychotic Medications: Pharmacolog-

ical Profiles and Psychological Implications, 3\ Prof. Psychology: Res.

& Prac. 628 (2000) (“newer antipsychotic agents may make patients

with schizophrenia more amenable to psychosocial and rehabilitative

interventions”).

'* Kane & Malhotra, supra, at 1027 (“Overall, the new-generation

antipsychotic drugs do provide clear advantages in terms of reducing

adverse effects (particularly drug-induced parkinsonism, akathisia, and, it

is hoped, tardive dyskinesia).”); id at 1034-35 (for olanzapine, a 1997

study showed “a significantly lower incidence of treatment-emergent

dyskinesia among olanzapine-treated patients”) (citation omitted); id at

1035 (“In summary, as a class, the second-generation antipsychotics

clearly have advantages over conventional drugs particularly in the area of

adverse effects (with the exception of weight gain [a side effect of some,

but not all, of the newer drugs]).”); Kaye & Reed, supra, at 316 (“4after

over 10 years of clinical use, there are still no confirmed cases of TD from

exposure to clozapine”; for risperidone, olanzapine, and quetiapine, “evi-

dence for increased safety” is “impressive. The apparent incidence of TD

with risperidone is between 0.03 and 2.4 percent. With olanzapine the

19

of neuromuscular problems, the standard of care for schizo-

phrenia is rapidly moving toward the newer antipsychotics,

even with their own side effects, as the first line of

treatment. '”

3. Delusional Disorder. The effects of medication for a

particular individual with a particular diagnosis is a matter for

a case-specific factual determination, as was made based on

expert testimony at multiple judicial levels in this case. Cf

Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 336 U.S.

271, 275 (1949) (under “two court” rule, Court rarely disturbs

concurrent findings, or case-specific applications of accepted

legal principles, of two courts below); Neil v. Biggers, 409

U.S. 188, 193 n.3 (1972). Nevertheless, some general infor-

mation about delusional disorder—the relatively rare disorder

(compared to schizophrenia) that is, at least tentatively,

involved in this case—is useful in considering the record here.

As that record indicates, the evidence respecting treatment of

delusional disorder is less definitive than for schizophrenia

incidence of TD is 0.5 to | percent compared with 4.5 to 7.5 percent for

haloperidol.”) (footnotes omitted)

Aside from the reduced risk of tardive dyskinesia from the new

medications, there is some evidence, since Riggins, that the abnormal

involuntary movements characteristic of tardive dyskinesia are at least

partly the result of the psychotic illness itself, rather than of the

medications. Gervin et al., Spontaneous Abnormal Involuntary Move-

ments in First-Episode Schizophrenia and Schizophreniform Disorder:

Baseline Rate in a Group of Patients From an Irish Catchment Area, \55

Am. J. Psychiatry 1202 (1998); Khot et al., Not All That Moves Is Tardive

Dyskinesia, 148 Am. J. Psychiatry 661 (1991); see Weiden, supra, at 109

(tardive dyskinesia can worsen upon stopping older medications, which

may, during use, suppress symptoms of the disease).

"Kaye & Reed, supra, at 331; see Pinals & Buckley, Novel Anti-

psychotic Agents and Their Implications for Forensic Psychiatry, 27 J.

Am. Acad. Psychiatry & L. 7 (1999). Progress in this field is continuing.

See note 4, supra (new injectable atypicals); Brook et al., Intramuscular

Ziprasidone Compared With Intramuscular Haloperidol in the Treatment

of Acute Psychosis, 61 J. Clinical Psychiatry 933 (2000); Geddes

(2002), supra.

20

and other more common psychotic illnesses (which also are

less resistant to collecting systematic data); fairly recent

summaries can be found in the pertinent chapter of the 2000

Textbook at 1243-64 (Manschreck, Delusional Disorder and

Shared Psychotic Disorder), and the 1999 Munro book,

supra. Against this background, the testimony of Drs. De-

Mier and Wolfson, including the responses to Dr. Cloninger,

supports the findings about medication here—its medical

appropriateness, the prospects for restoring competence, and

the lack of realistic alternatives.

Patients with delusional disorders are relatively uncom-

mon, have often not been identified in a distinct diagnosis, are

outside many clinicians’ experience, and have been difficult

to study systematically because they “do not regard them-

selves as mentally ill and actively oppose psychiatric

referral.” Textbook at 1243, 1244, 1248-50. Although, for

such reasons, delusional disorder “has generally been re-

garded as resistant to treatment” (id. at 1262), “[l]imited but

growing evidence supports * * * [delusional disorder’s] dis-

tinctiveness from schizophrenia and mood disorder as well as

its treatability.” /d. at 1243; id. (“recent reports suggest that

favorable responses to psycho-pharmacologic and psycho-

therapeutic interventions are more common than previously

thought”). Although the disorder can remit over time, it also

can be lifelong; it generally develops by “gradual, progressive

involvement with the delusional concern”; meanwhile,

patients “suffer” and “often feel demoralized, miserable,

isolated, and abandoned.” /d. at 1261-62. Non-pharma-

cologic treatments have “not been studied enough to justify

recommendation.” /d. at 1262. Medication has been more

successful, though “the results required to support this prac-

tice empirically have been only partially obtained.” /d. at

1262 (emphasis added). In particular, case reports and stud-

ies based on them—which are “especially valuable” as evi-

dence (id. at 1263) given the difficulties of obtaining more

systematic studies-have shown success with pimozide

or.

21

(Orap), an older medication, lesser success with other typical

neuroleptics, and some success with “atypical” medications.

Id. at 1251, 1253, 1262-63.

Dr. Munro, a leading researcher in the field, likewise noted

in 1999 the “gloomy outlook” among “physicians not familiar

with the modern literature”; observed that this “illness which,

if allowed to go untreated, is certainly both severe and

disabling”; and concluded that “[m]Jany anecdotal treatment

results, and a small number of double-blind drug trials,

appear to show a consensus that delusional disorder, despite

its traditional resistance to treatment, can now be regarded as

an eminently treatable illness.” Munro at 3-4, 6. He added

that “pimozide tends to be the most widely used drug” and

“appears to give very good results, but * * * the evidence is

still insufficient to know whether it is inherently superior to

other neuroleptics in treating delusional disorder.” /d. at 6.

Munro explained that delusions “can fluctuate in intensity

over time, even in the absence of treatment”; and treatment

does not “necessarily cure delusions, but * * * can allay them

to the point where they are either no longer evident or

interfere minimally with normal functioning.” /d. at 32. One

reason the reports of treatment are still mostly “anecdotal”

(i.e., reports of small numbers of cases, not statistically large

samples), id. at 227, is “the notorious reluctance of delusional

disorder patients to engage in psychotropic drug trials.” /d. at

229; id. at 237 (“delusional disorder patient’s excessive

wariness and suspicion” may make “conventional double-

blind drug trials * * * all but impossible”). The reports

“overall add[] up to a refutation of the belief that delusional

disorder is irremediable,” and “[v]irtually all of these reports

refer to psychopharma-cological treatment.” /d. at 227; see

id. at 234 (no evidence “suggests that psychological

approaches are effective in treating actual delusional dis-

order”). As to doses and duration: starting with a very low

dose (1-2 mg daily) of pimozide or other medication, and

gradually increasing (up to 4-6 mg), “it takes about two

22

weeks of continuous, adequate treatment to produce signifi-

cant amelioration of the delusion,” though “in some patients it

may be six weeks or longer.” /d. at 233. As of 1999,

pimozide was “the best documented and most cost effective

intervention in delusional disorder.” /d. at 238. Although

“{t}reatment aspects of delusional disorder are in crying need

of good, experimentally-based drug trials” (id. at 240), Munro

concluded in 1999: “delusional disorder, properly diagnosed

and adequately treated, has an optimistic outlook. Whatever

the neuroleptic employed, the overall rate of response, total

or partial, 1s approximately 80 per cent, an outcome that

compares well with any other in psychiatry. It is clearly

desirable to identify and, if possible, treat cases.” Jd. at 237.~°

B. The Interests Supporting Medication Are

Weighty

This Court has often described the “compelling interest in

finding. convicting, and punishing those who violate the

law.” Moran v. Burbine, 475 U.S. 412, 426 (1986): accord

Texas \. Cobb, 532 U.S. 162, 172 (2001); Gray v. Maryland,

523 U.S. 185, 202 (1998) (Scalia, J., dissenting); McNeil v.

Wisconsin, 501 U.S. 171, 181 (1991); Richardson v. Marsh,

481 U.S. 200, 210 (1987): Garrett v. United States, 471 U.S.

773, 796 (1985) (O’Connor, J., concurring); Winston v. Lee,

470 U.S. 753, 762 (1985). More pointedly, the interest in

adjudicating the charges, one way or the other, is a great one.

See Riggins, 504 U.S. at 135-36 (quoting //linois v. Allen, 397

U.S. 337, 347 (1970) (Brennan, J., concurring): “[c]onstitu-

tional power to bring an accused to trial is fundamental to a

” See Felthous et al, Are Persecutory Delusions Amenable to Treat-

ment’, 29 J. Am. Acad. Psychiatry & L. 461 (2001) (describing reasons

for lack of systematic studies: summarizing evidence of positive results of

medication, noting limitations-seven patients. short treatment, long-term

delusions-of Silva, Effects of Pimozide on the Psychopathology of Delu-

sional Disorder, 22 Prog. Neuro-Psychopharmacol. & Biol. Psychiatry

331 (1998)). The chapter relied on by Dr. Cloninger (JA91-135), from

1988, notes that “[a}ntipsychotic medication may be useful.” JA106.

— oe

ene Seti -

23

scheme of ‘ordered liberty’ and prerequisite to social justice

and peace”). The Court has also recognized the public

interest in prompt adjudication. See Flanagan v. United

States, 465 U.S. 259, 264-65 (1984); Barker v. Wingo, 407

U.S. 514, 519-20 (1972).

Importantly, these interests supporting restoration of com-

petence rarely stand alone when medication is medically

appropriate. Although a defendant may judge the risk of

conviction an overriding one, or otherwise wish to forego the

benefits of needed medication, the Court should not ignore

the real costs of leaving a defendant untreated when he needs

such treatment. These include the costs to the defendant

himself (a concern that is especially strong if competency to

make treatment decisions is also impaired). Languishing

without treatment leaves in place the suffering and impair-

ment of functioning that psychoses cause—the core reasons for

medication qualifying as medically appropriate. In addition,

there is evidence (though it is not definitive) that delaying

treatment, like allowing other kinds of disease to fester, can

cause physical alterations (here, in brain structures) to make a

psychotic condition worse, harder to treat, and more likely to

recur after treatment.”' The costs for the individual include,

as well, the other individual harms from needless institu-

tionalization the Court recognized (at the APA’s urging) in

Olmstead v. L.C. by Zimring, 527 U.S. 581 (1999).

Though treatment should not be given unless appropriate

for the individual, of course, other individuals also are ad-

2" See J. Preston, supra, at 112 (“there is now evidence to support the

notion that being psychotic is damaging to the brain”); Loebel et ai.,

Duration of Psychosis and Outcome in First-Episode Schizophrenia, 149

Am. J. Psychiatry 1183 (1992); Wyatt, Neuroleptics and the Natural

Course of Schizophrenia, \7 Schizophrenia Bull. 325 (1991), Baldes-

sarini, supra, at 451 (“There is some evidence that abrupt discontinuation

of antipsychotic medication is associated with more frequent and earlier

relapses * * *.”); Textbook at 38-40, 1198 (untreated episodes may create

brain structures worsening illness and making it more refractory).

24

versely affected by leaving the individual untreated. The

families of severely disturbed individuals suffer many conse-

quences of their loved ones’ psychoses, through both the loss

of self and the behavior such psychoses cause. And when an

individual is in an institution, leaving him untreated can be

unhealthy for other individuals served by the institution, even

when the individual is not physically dangerous. The

treatment environment is important, as reflected in the

emphasis over the past decades on de-institutionalization and

improvement of institutions. That environment is harmed,

e.g., impairing calm and confidence, by exposure to the

agitation, disruption, senseless communication, and languish-

ing associated with untreated psychoses. See Amarasingham,

Social and Cultural Perspectives on Medication Refusal, 137

Am. J. Psychiatry 353 (1980); Abroms, Defining Milieu

Therapy, 2\ Archives Gen. Psychiatry 553 (1969). |

Leaving untreated a defendant who is incompetent to stand

trial harms other public interests too. If enough time passes,

the government may lose its ability to try the charges at all.

With competence unlikely to return without medication, there

is a genuine potential for defendants to refuse medication for

lengthy periods-the more serious the charges, perhaps, the

greater the potential—while waiting for evidence to grow stale

or the cases against them otherwise to weaken. And since

refusal of medication often will leave the individual confined,

the government will incur mounting costs of institutional-

ization. A collateral consequence of institutionalizing many

patients who cannot be given medically appropriate treat-

ment, moreover, is damage to the government’s ability to hire

and retain professional staff, forced to act more as jailers or

custodians than as caregivers.

Under 18 U.S.C. §§ 4241, 4246, there is a realistic possi-

bility of long-term, open-ended confinement of many crimi-

nal defendants found incompetent to stand !rial. Confinement

is allowed if incompetence remains and “release would create

a substantial risk of bodily injury to another person or serious

25

damage to property of another.” /d. § 4246. The relevant

risk is not judged by reference to restraints possible in prison.

Many criminal defendants who are incompetent to stand trial

would remain confined indefinitely under this statute (let

alone under broader standards Congress might choose to

adopt for defendants incompetent only as a result of their own

refusal of appropriate medication). Without needed medica-

tion, restoration of competence is unlikely according to the

best medical prediction at the time of decision, and in any

event the possibility is not bounded by any knowable

duration. Given the dearth of comparably effective alterna-

tives to antipsychotic medication, a defendant may remain

incompetent to stand trial indefinitely.

Whatever constitutional questions might arise on a full

analysis, indefinite confinement in likely circumstances of

incompetence based on refusal of medication is not precluded

by Jackson v. Indiana, 406 U.S. 715 (1972). Jackson was not

being held under a finding of dangerousness, so the decision

is inapplicable to standards for confinement based on danger.

In any event, all Jackson held was that, when an individual

was confined (outside normal civil commitment processes)

for the purpose of restoring competence, that confinement

became impermissible if the individual could not be restored

to competence, because such confinement is not reasonably

related to its purpose. But Jackson does not restrict the

confinement of an individual who voluntarily prevents his

own restoration to competence-for whom confinement is

reasonably related to the purpose of the confinement.

C. First Amendment and Fair Trial Interests

Should Not Alter the Constitutional Balance

1. Speech Interests. First Amendment interests do not

alter the constitutional balance for antipsychotic medications

that are justified under the due process standard already

discussed. The medications, when appropriate, aim to clear

the hallucinations and delusions produced by psychosis, or to

allow the patient to recognize and control their dominating

26

influence. They thus alleviate the mental suffering and func-

tional impairments, producing “/oss of freedom,” characterize

severe mental illness. See DSM-IV-TR at xxxi (emphasis

added). The medications, when properly used to treat the

severely mentally ill, positively promote First Amendment

interests by enhancing abilities to concentrate, read, learn,

and communicate. The evidence contradicts the “view of

these drugs as mind-altering, thought-inhibiting, or destruc-

tive of personality in a negative sense. In fact, the beneficial

effects of the medication on complex aspects of mentation

suggest that the opposite conclusion is true: the medications

reinforce the most important aspects of mental functioning.”

Relatedly, as the APA explained in Riggins, “[t}he mental

health produced by antipsychotic medication is no different

from, no more inauthentic or alien to the patient than, the

physical health produced by other medications, such as peni-

cillin for pneumonia (which might be labeled ‘synthetic

fitness’ or ‘synthetic health’).” APA Riggins Br. 9; see

Riggins, 504 U.S. at 141 (Kennedy, J., concurring in the

judgment).”’

* Gutheil & Appelbaum, “Mind Control,” “Synthetic Sanity,” “Arti-

ficial Competence,” and Genuine Confusion: Legally Relevant Effects of

Antipsychotic Medication, 12 Hofstra L. Rev. 77, 119 (1983); see

Felthous, supra, at 466 (“Rather than mind restricting, the medication is

mind liberating.”); Appelbaum & Gutheil, Rotting With Their Rights On,

7 Bull. Am. Acad. Psychiatry & L. 306, 310 (1979). 4

“These days, when people are treated with modern psychiatric

medication, one of the most common remarks therapists hear once the

medications begin to take effect is, ‘1 am beginning to feel like myself

again.’ This is a very important point to emphasize. Although some

medications do have unpleasant side effects, and some misuse of these

drugs certainly continues, the goal of appropriate psychiatric treatment is

twofold: (1) to reduce human suffering and (2) to promote the develop-

ment and expression of autonomy. This a far cry from the chemical

Straitjackets of the mental hospitals’ back wards in the 1950s.” J. Preston,

Consumer 's Guide to Psychiatric Drugs 14 (2000)

~

xv -

27

In any event, the analysis does not change by adding any

First Amendment interest to the personal-autonomy interest

protected by due process standards. “{Gjovernment regula-

tion is sufficiently justified if it is within the constitutional

power of the Government; if it furthers an important or

substantial governmental interest; if the governmental interest

is unrelated to the suppression of free expression; and if the

incidental restriction on alleged First Amendment freedoms is

no greater than is essential to the furtherance of that interest.”

United States v. O'Brien, 391 U.S. 367, 377 (1968). Those

conditions are met if the due process justification is

established—if the medication is needed to serve the public

interest in adjudicating serious criminal charges, an interest

unrelated to suppressing any free expression.

2. Fair Trial Interests. The Court (and the APA) in

Riggins acknowledged that antipsychotic medication can

create adverse effects on a defendant's role at trial, thus

triggering a duty of justification on the part of the government

enforceable in the criminal case. But the interest in avoiding

such effects does not alter the basic weight of the com-

petence-restoration justification. In the majority of cases,

resolved by guilty plea, effects at trial are immaterial. More-

over, unless there is an unusual reason to know otherwise at

the outset, legitimate interests in avoiding unjustified adverse

inferences by the jury can readily be addressed after com-

petence is restored. Finally, an interest in “appearing psy-

chotic” does not deserve significant weight.

The effect of administering appropriate medication will, in

all likelihood, be the very opposite of impairing trial rights.

Such medication likely will “‘enhance some of Weston’s trial

rights, particularly his right to consult with counsel and to

assist in his defense.’”” Weston, 255 F.3d at 883 & n.6.

Moreover, such medication “will more likely improve,” not

impair, “Weston’s ability to relate his belief system to the

jury.” Jd. at 884. And, while a criminal defendant has a

“right to be present at trial in a state that does not prejudice

28

the factfinder against him”—which could occur through, e.g., a

“flattened emotional affect” from some medication—“medica-

tion will likely enhance rather than impair [a defendant’s]

right to a fair trial,” including by restoring the ability to

present more appropriate facial responses. /d. at 885.

Critically, although “[t]he possibility of side effects from

antipsychotic medication is undeniable,” the ability of “treat-

ing physicians and the district court to respond to them sub-

stantially reduces the risk they pose to trial fairness.” Weston,

255 F.3d at 885. The effects can be monitored and typically

controlled (id. at 885-86), whether through choosing among

the medications (which have widely varying risks of side

effects on movement, sedation, etc.), reducing dosages,

adding a counteracting medication, or otherwise. Physicians’

ability to control such effects, moreover, can be directly

supplemented—for purposes of alleviating any illegitimate

adverse effect on the defense—by the district court’s manage-

ment of the case. The district court can inform the jury of the

medication and its effects and can allow testimony on those

effects, disabusing the jury of adverse illegitimate inferences

from demeanor. /d. at 886. With those bases for addressing

fair-trial concerns, the Weston court sensibly concluded:

“Whether antipsychotic medication will impair Weston’s

right to a fair trial is best determined when the actual effects

of the medication are known, that is, after he is medicated.”

255 F.3d at 886 n.8. The Gomes court and the Eighth Circuit

here reached the same sound conclusion.

A case involving a defense of insanity should not be

materially different. The constitutional analysis should focus

on reliable evidence, not tactical considerations that, though

they may be real, exploit unfair or unreliable evidentiary

inferences. With the ability to monitor and control harmful

demeanor effects, the ability to inform the jury of medica-

tion’s effects, and the availability of other more probative

evidence on the issue of insanity, there is a relatively “small

risk” that a jury would take a medicated defendant’s “testi-

29

mony (if he decides to testify) as an indication that he must

have been sane at the time of the crime, or that he is making it

up, or that he deserves no sympathy.” Weston, 255 F.3d at

884. The same assessment applies to the defendant’s general

appearance at trial, whether as witness or at counsel table.

Any interest a defendant may have in affirmatively appear-

ing before the jury in an unmedicated state does not warrant

being given significant weight here. Most basically, where

medication is needed to restore competence, denying medi-

cation cannot generally produce the trial (with defendant

unmedicated) that this interest invokes. Seemingly, the de-

fendant would have to take medication to become competent,

then waive his competence at trial (if waiver is lawful), then

stop medication and return to incompetence for trial. But

petitioner objects even to the first step; in any event, there is

surely a strong interest in not requiring the judicial system to

try an incompetent defendant.”

In addition, the evidentiary significance of demeanor in

legitimately establishing the defendant’s insanity at the time

of a crime is not particularly strong. An individual’s psy-

chotic state may not be evident in his or her appearance or

demeanor. A person who appears calm may be no more or

less insane—“as a result of a severe mental disease or defect,

[he] was unable to appreciate the nature and quality or the

wrongfulness of his acts” (18 U.S.C. § 17)+than an individual

who exhibits anxious or active forms of behavior. Moreover,

even without medication, a defendant’s courtroom demeanor

may differ from what it was at the time of the charged

offense: time, the courtroom setting, or the structured prison

environment can alter demeanor. The evidentiary nexus

between demeanor and sanity is relatively weak.

* Such a trial might be unlawful. See 18 U.S.C. § 4241(a); Godinez,

509 U.S. at 396; Drope v. Missouri, 420 U.S. 162 (1975); Pate v.

Robinson, 383 U.S. 375 (1966); see Pet. App. 7 (“The government may

not constitutionally bring an incompetent defendant to trial * * *.”).

30

At the same time, other evidence diminishes any adverse

effect from the absence of an unmedicated demeanor and

more reliably addresses the issue of insanity at the time of the

offense. The jury may be educated, by the judge or by expert

witnesses, about the fact that the defendant is taking medi-

cation and why he may not “appear psychotic.” The defend-

ant may be videotaped in an unmedicated state close in time

to the offense. Psychiatric experts and other witnesses will

often provide more reliable evidence about the defendant’s

state of mind at the time of the offense. See also Weston, 255

F.3d at 884-85 (a defendant has no general right “to replicate

on the witness stand his mental state at the time of the crime,”

giving examples of intoxication and heat of passion). The

constitutional analysis of administration of needed medica-

tion, in sum, should not be altered for insanity-defense cases.

CONCLUSION

Antipsychotic medications should be treated no differently

from other medications. When medically appropriate (based

on a_ benefit-risk balance), and reasonably likely and

reasonably needed to restore competence, such medication

may constitutionally be compelled for that purpose in a case

involving a serious enough offense.

Respectfully submitted,

RICHARD G. TARANTO*

FARR & TARANTO

1220 19th Street, NW

Suite 800

Washington, DC 20036

* Counsel of Record (202) 775-0184

January 22, 2003 5