Petition for Writ of Certiorari — United States v. OAKLAND CANNABIS BUYERS'COOPERATIVE

7—Supremé Court, U.S

\Y FILED

00

In the Supreme Court of the Gnited States

UNITED STATES OF AMERICA, PETITIONER

Vv.

OAKLAND CANNABIS BUYERS’ COOPERATIVE AND

JEFFREY JONES

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

SETH P. WAXMAN

Solicitor General

Counsel of Record

DAVID W. OGDEN

Acting Assistant Attorney

General

EDWIN S. KNEEDLER

Deputy Solicitor General

LISA SCHIAVO BLATT

Assistan’ to the Solicitor

General

Department of Justice

Washington, D.C. 20530-0001

(202) 514-2217

QUESTION PRESENTED

Whether the Controlled Substances Act, 21 U.S.C.

801 et seg., forecloses a medical necessity defense to the

Act’s prohibition against manufacturing and distri-

buting marijuana, a Schedule I controlled substance.

(I)

TABLE OF CONTENTS

SAREE Rice aaa nN te eA

SuETITTTITT lcd tisdaramycbdindiamnsocndtnicintenteaseseenhenitnstssaddathslutihasaniinaenassias

Reasons for granting the petition ......ccccsssssssessssssessssseeeesssvees

eet aR EE ELT NATL ETET

TABLE OF AUTHORITIES

Cases:

Accardi v. Pennsylvania R.R. Co., 383 U.S. 225

SINE seseibsabvnheelaessiniacinbiei lie haestiaseicieiparnadguhicesdhanabishbicimtainsakoncens

Alliance for Cannabis Therapeutics v. DEA, 15 F.3d

I a IS I na sacs ccin iss ordnenastencceate

Harris v. United States, 359 U.S. 19 (1959) ..-ccccccecsceeccoeoees

Hecht Co. v. Bowles, 321 U.S. 321 (1944)

Jenks v. State, 582 So. 2d 676 (Fla. Dist. Ct. App.),

review denied, 589 So. 2d 292 (1991)

Kauffman v. State, 620 So. 2d 90 (Ala. Crim. App.

ARRAS tt Ne

Milier v. French, No. 99-224 (June 19, 2000) ...--ccccccesoss-..

Murphy v. Commonwealth, 521 S.E.2d 301 (Va. Ct.

RIOT -sielileraissticanehtsasdipecrbsuietaciociaabasasosdieiaboseiitnieenegediees

Northern Cheyenne Tribe v. Hodel, 851 F.2d 1152

I I ciciciseieseis tlecdtaainioninasecnietcnnstvebiircians sk

State v. Bachman, 595 P.2d 287 (Haw. 1979) ....ccccecosco----

State v. Christen, 704 A.2d 335 (Me. 1997) ...cccccccccccecccoo-----.

State v. Cramer, 851 P.2d 147 (Ariz. Ct. .

State v. Hastings, 801 P.2d 563 (Idaho 1990) ......00........

State v. Ownbey, 996 P.2d 510 (Or. Ct. App. 2000) ............

State v. Poling, No. 26658, 2000 WL 572334 (W. Va.

REE RER I S EA e O O e

(IIf)

y

oe

FTanwnwn-=B

12

IV

Cases—Continued:

State v. Tate, 505 A.2d 941 (NJ. 1986) ........sscscesssssssessesseees

State v. Williams, 968 P.2d 26 (Wash. Ct. App.

1998), review denied, 984 P.2d 1034 (1999) ........ccsscceeeseees

TVA v. Hill, 437 U.S. 153 (1978) .........cccccccseeee

United States v. Allerheilgen, No. 97-40090-01-DES,

1998 WL 918841 (D. Kan. Nov. 19, 1998) ..........scscsscssssseseees

United States v. Bailey, 444 U.S. 394 (1980)

United States v. Belknap, No. 92-5363, 1993 WL

SOBTE Coda Cr. FR. TAD, REID cccessteneissnctnneseennsicnicssivinisissniceaninni

United States v. Burton, 894 F.2d 188 (6th Cir.),

cert. denied, 498 U.S. 857 (1990) ........cscssseeees

United States v. Diana, No. CR-98-068-RHW

CES... Weis, Game, FE TIED nessinrienssninsnssinninintoeninnierittinctiacitinencantion

United States v. Fogarty, 692 F.2d 542 (8th Cir.

1982), cert. denied, 460 U.S. 1040 (1983)

United States v. Greene, 892 F.2d 453 (6th Cir.

~ 1989), cert. denied, 495 U.S. 935 (1990) ....sscccssssssscesssseeseessnes

United States v. Kiffer, 477 F.2d 349 (2d Cir.),

cert. denied, 414 U.S. 831 (19738) ..........cccscsssssserscsrssersseseeserers

United States v. Lederer, No. CR-97-558 GEB

(E.D. Cal. May 21, 1999) ............cscsssssees

United Sates v. McWilliams, No. CR 97-997(A)-

See, Ckalets Ss Os Oh II sninsasicsnisicintaciclnititeniinsinasiiacinieti

United States v. Middleton, 690 F.2d 820 (11th

Cir. 1982), cert. denied, 460 U.S. 1051 (1983)

United States v. Moore, 423 U.S. 122 (1975) .......c.ccecsecseeee

United States v. Oakland Cannabis Buyers’ Coop.,

No. 99-15838, 2000 WL 569509 (9th Cir. May 10, 2000) ....

5

United States v. Rutherford, 442 U.S. 544 (1979) .... 14, 15, 21

United States v. Schoon, 971 F.2d 193 (9th Cir.

1991), cert. denied, 504 U.S. 990 (1992) ..........cccscsscsecssssceesees

United States v. Smith, No. 99-10447 (9th Cir.

a Bi Be iced cadhceapiicecenicinsessciaidscidlidicigaiigh cian atindiinas Atataaabiad

BBE) cencemnsesntin os nenonedienentenaiiannintacetnniann

Cases—Continued: Page

Virginia Ry. Co. v. System Fed’n No. 40, 300 US.

SD ARTES sesnianteieiehcasaiibcantedpublciicacheaihelcedpsinkaschaamepeiohienileseeiaanebiangne 17

Constitution, statutes and regulations:

U.S. Const. Amend. V .........ccscsssssssesees jag a 5

Controlled Substances Act, 21 U.S.C. 801 et sq. .....cscceseeeee 2

Be Sis PIE. crentenricreinipssncinmnnenicenscmminincnncccemmeninnemeerees 9

21 U'S.C. 811... : 13, 19

21 U.S.C. 811(a) dipiniinstiallliameiiainieinitentspuiaione 10

21 U.S.C. 811(b) ......... . 10

B1 UBC, SID cccccecccscccsees - sai 19

Be a EE Meatlascccereischetimniseninvenisinisignintiannecn 7, 9, 13, 18

en ED cchstcsnchisacianssmeabcasiisateccicintaicieliatinncimepeatciiineneoonin 10

Bk Rs I sechcrnrsieneccesnciemannetnmmintahinisninineiameninaennnetitt 13

Fe TGs PED irenintinitteptioniiinninmetiai 13

Be EE pretcietinniciniciectmaticcnenttnigeennininaniiniatinets SEE CRE 13

BE FFAS SD sctrreensscsrrecnnesnsestnennsnenncensirpeisasanenpnceainbinn 9, 13, 18, 19

21 U.S.C. 826 seveliaiiebceacatapeiveinicapheanininaantiphanseiananae 14

21 U.S.C. 827....... (eisniceemvenninnionenateinmasiaomnnmmineriaie 14

Ek aE cecieteniusienttnicicnerimneintiascntseniommnnensieihinittciniuipeureners 14

Be RFs BUD cercncrtsinrnnicetenonieeninmengnnncentingenneramenemiainnmmeeeanin 9,14

21 U.S.C. 841-863 (1994 & Supp. [IV 1998) ..........ccssssseseees 3

Fe Ss SE scsecicitihidcletnlanstneaitiredailalaiehaiindaaidaeaeighabainaations 18

NS 5. ciccccnciihacntensandanainen 6, 9, 13

21 U'S.C. 877 ........ sianiiuliasdatameancinetiiaieciuesiiininamsatinenacissiahinnin 10

BE UA. OO cxceccvitnenpnins siosniniaailiiialehiclabsasitaien 13-14

Be SE IID eciieipenteiniviepsshcclanetapnicchinsaieiestiaatessiie ie 3

Pub. L. No. 105-277, Div. F, 112 Stat. 2681-760 to

__,_ aRnRnWES Re arn un Ee SHEN REN Chant ae 2,7, 12

21 C.F.R.:

Pt. 5:

es ee witsiintckssntiisieancsintipntiessiisibbainitatciibea initial 9

VI

Statutes and regulations—Continued: Page

Pt. 1301:

Ms BING iecsissitscrncssissirihinsibicsushebeeninvseniitcibniceanianimeinpuebees 13

eis RIDES wiscccsesnciccccnscsseierstisisiticsesenvnninionsnsnniticeinianinn , 9

Section 1301.32 ....... iichineniateeniadinahaeuianesiasistentidedines 9

Boctlets BOOT. TA-EBOL TG occscssscececosescssesnevensnsnacnssnenonasionsnstens 13

ate SEIN, :csdisiheconeenhdvtecanenbinichapieiinesiatenhinceanieaeiaptinaanetn 14

I TION aiscicittnssccstiniedeniebsonenieneeneniindatanieaassbeineanaceitainieihh 14

BtBOns BGG cecscrescoecessccoscoososcsvesentossvensosnsionecssesesoasinensessessesons 14

Sie TEI is ncctncnerssnveseésvisoncesenssnbasethionssaubptpgnanptannaeneneasentiis 14

eR TIED cccacevesescnsenscenssonesnscnsesesonsbebtensniannnatesanianeseniedn 10

BB CBR. 0.100) crcccccccresesecocececesseeessceseseeecnveensnsonoseoneconecsobenecess 9

Alaska Stat. (Michie 1999):

§ 11.71.0980 .reccscccrrcescerccrcceccsecceccsecervecccsccscceoveeveeseososesoossoesoooooonees 20

§ 17.BTD10-1T BT ..eccrccsrocerescssvrscesserevececevceseesesecnecesnsvssevssesee 20

Cal. Compassionate Use Act (Nov. 1996) ssssssssssssssssssssnssnees 2

Cal. Health & Safety Code (West 1999):

§ 119G2.B(D LANA) ccorsrecsrssersesesnesessesssvcssossscnssscsscssocssnsssssesesseoses 2, 20

§ 2IDGB BCE) srcccccrssrecvercsrcrcconvesescnsvcevoncsecssonscsssnoecsesesssevesoneveonsveoe 2, 20

Or. Rev. Stat. §§ 475.3800-475.346 (1999) ...ssssssssssrsererererenes 20

Wash. Rev. Code § 69.51.010-69.51.080 (1997) ....sssserererereres 20

Miscellaneous:

144 Cong. Ree.:

p. H7720 (daily ed. Sept. 15, 1998) .....sssssscsssssssssesssssseseesssnnes 12

p. $10,666 (daily ed. Sept. 21, SEI scininiitaahtictetiibahaivieiaphanaliene 12

145 Cong. Rec. H12,238 (daily ed. Nov. 17, 1999) ........sss0 20

Carey Goldberg, Maine Mulls Medical Use for its Seized

Marijuana, N.Y. Times, Mar. 14, 2000 at Nat’! Desk ....... 20

Haw. S.B. 862, 20th Legis. (1999) (signed into law on

July 12, 2000) ......sssssccsresessnesecnnessssvesssnecssnssessnrsssnecsenecerssecenscssnes 20

1 Walter LaFave & Austin W. Scott, Jr., Substantive

Cortaretatal Tew CUGBG) .esconseoesecsecscersncenecssescesonbensenesoconegosonssoonee ~

U.S. Dep’t of Commerce, Statistical Abstract of

the United i I ssa hadsiln cli lealinsiidlabanialda 19

In the Supreme Court of the Gunited States

No.

UNITED STATES OF AMERICA, PETITIONER

VU.

OAKLAND CANNABIS BUYERS’ COOPERATIVE AND

JEFFREY JONES

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

The Solicitor General, on behalf of the United States

of America, respectfully petitions for a writ of certiorari

to review the judgment of the United States Court of

Appeals for the Ninth Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (App. la-11a)' is

reported at 190 F.3d 1109. The May 13, 1998 memoran-

dum and order of the district court (App. 41a-81a) is

reported at 5 F. Supp. 2d 1086. The other opinions and

orders of the district court (App. 12a-40a) are un-

reported.

1 “App.” refers to the separately bound appendix to the petition

for a writ of certiorari.

(1)

2

JURISDICTION

The judgment of the court of appeals was entered on

September 13, 1999. A petition for rehearing was

denied on February 29, 2000 (App. 82a). On May 22,

2000, Justice O’Connor extended the time within which

to file a petition for a writ of certiorari to and including

June 28, 2000, and on June 19, 2000, Justice O’Connor

further extended the time within which to file a petition

to and including July 28, 2000. The jurisdiction of this

Court is invoked under 28 U.S.C. 1254(1).

STATUTORY PROVISIONS INVOLVED

The relevant provisions of the Controlled Substances

Act (CSA), 21 U.S.C. 801 et seq., and Pub. L. No. 105-

277, Div. F, 112 Stat. 2681-760 to 2681-761, are set forth

at App. 83a-92a.

STATEMENT

1. On January 9, 1998, the United States filed suit

seeking an injunction against six marijuana distributors

and ten associated individuals, alleging that the defen-

dants’ ongoing distribution (and in some cases manufac-

ture) of marijuana violated the Controlled Substances

Act (CSA)2 On May 19, 1998, the District Court for

the Northern District of California issued a preliminary

injunction prohibiting the Oakland Cannabis Buyers’

Cooperative and its director (collectively OCBC) and

other marijuana distributors from manufacturing and

distributing marijuana. App. 39a-40a (order); 41a-8la

2 Many such groups formed in the wake of California’s

Compassionate Use Act, or Proposition 215, passed in November

1996, which purports to authorize the possession and use of mari-

juana for medical purposes upon a physician’s recommendation.

See Cal. Health & Safety Code § 11362.5(b)(1)(A) and (d) (West

1999).

3

(memorandum opinion).’ On May 21, 1998, OCBC vio-

lated the injunction by openly distributing marijuana to

numerous persons. Jd. at 2la-23a. On October 13,

1998, the district court issued an order finding OCBC in

civil contempt. Jd. at 20a-37a. On October 16, 1998, the

district court issued an order denying OCBC’s motion

to modify the injunction to permit marijuana distribu-

tion to persons who, in OCBC’s view, have a “medical

necessity,” i.e., persons having a doctor’s certificate

stating that (1) the person suffers from a serious

medical condition; (2) the person would suffer imminent

harm if he does not have access to marijuana; (3)

marijuana is necessary for treatment of the person’s

condition or would alleviate the condition or symptoms

associated with it; and (4) there is no legal alternative

for the effective treatment of the condition because

alternative legal drugs are either ineffective or result in

intolerable side effects. Jd. at 19a (denying motion for

modification); see also id. at 7a-8a, 28a-29a (describing

proposed medical necessity defense).

2. In a per curiam opinion, the court of appeals

reversed the district court’s denial of the motion to

modify the injunction to allow the use of marijuana

based on asserted medical necessity. App. la-lla.* The

3 In addition to the imposition of criminal and civil penalties for

violations of the CSA, see 21 U.S.C. 841-863 (1994 & Supp. IV

1998), the CSA gives district courts jurisdiction to enjoin violations

of the Act, 21 U.S.C. 882(a).

4 The court of appeals also held that it lacked jurisdiction over

OCBC’s appeal of the district court’s denial of a motion to dismiss,

App. 2a-5a, and that OCBC’s appeal of the district court’s order

finding it in contempt was moot because the district court on

October 30, 1998, vacated its contempt order after OCBC repre-

sented to the court that it would comply with the injunction, id. at

5a-7a. Those rulings are not at issue here.

eC Re a ee a eee ET et Ce ee TR ee

4

court of appeals held that the district court, in

construing its equitable power to issue an injunction,

erred in not “tak[ing] into account a legally cognizable

defense that likely would pertain in the circumstances.”

Id. at 8a. The court of appeals explained that it saw “no

indication that the ‘underlying substantive policy’ of the

[CSA] mandates a limitation on the district court’s

equitable powers” “to formulate appropriate relief

when and if injunctions are sought.” Jd. at 9a (quoting

Northern Cheyenne Tribe v. Hodel, 851 F.2d 1152, 1156

(9th Cir. 1988)).

The court of appeals further concluded that the

district court abused its discretion in not considering

what the court of appeals described as the “strong

public interest in the availability of a doctor-prescribed

treatment that would help ameliorate the condition and

relieve the pain and suffering of a large group of

persons with serious or fatal illness.” App. 9a-10a.

“Indeed,” the court observed, “the City of Oakland has

declared a public health emergency” in response to the

district court’s denial of OCBC’s motion to modify the

injunction to authorize it to distribute marijuana. Jd. at

10a. The court also expressed the view that “(t]he evi-

dence in the record is sufficient to justify the requested

modification,” and the court had “no doubt that the

district court could have modified its injunction, had it

determined to do so in the exercise of its equitable dis-

cretion.” Jd. at 10a. “[B]y contrast,” the court con-

tinued, the government had identified no “interest it

may have in blocking the distribution of cannabis to

those with medical needs, relying exclusively on its

general interest in enforcing statutes.” Jd. at lla. The

court of appeals therefore remanded the matter to the

district court “to reconsider” OCBC’s request for a

modification of the injunction to allow OCBC to

5

distribute marijuana to persons who would satisfy

OCBC’s proposed test of medical necessity. Jbid.°

3. Following the Ninth Circuit’s decision, on May 30,

2000, OCBC filed a motion with the district court to

modify the district court’s injunction entered on May

19, 1998. On July 17, 2000, the district court granted

OCBC’s motion. App. 12a-17a. The court explained:

On remand the government has still not offered

any evidence to rebut [OCBC’s] evidence that can-

nabis is medically necessary for a group of seriously

ill individuals. Instead, the government continues to

press arguments which the Ninth Circuit rejected,

including the argument that the Court must find

that enjoining the distribution of cannabis to seri-

ously ill individuals is in the public interest because

Congress has prohibited such conduct in favor of the

administrative process regulating the approval and

distribution of drugs.

Id. at 18a. The court therefore stated that, “{a]s a

result of the government’s failure to offer any new

evidence in opposition to [OCBC’s] motion, and in light

of the Ninth Circuit’s opinion, the Court must conclude

5 On May 10, 2000, the Ninth Circuit issued an order vacating

and remanding the district court’s February 25, 1999, order dis-

missing the counterclaims for injunctive and declaratory relief

sought by individual intervenors who alleged that the preliminary

injunction violated their asserted substantive due process rights to

use cannabis to alleviate their medical conditions. The court of

appeals reasoned that, “[a]lthough the substantive claim of viola-

tion of Fifth Amendment rights that underlies plaintiffs’ claim in

this appeal differs from the defense of medical necessity upon

which we ruled in the earlier appeal, the injunctive remedy in-

volved in both appeals is similar.” United States v. Oakland

Cannabis Buyers’ Coop., No. 99-15838, 2000 WL 569509, at *1 (9th

Cir.).

sinc

6

that modifying the injunction as requested is in the

public interest” and that it would “exercise its equitable

discretion to do so.” Ibid.

The district court accordingly issued an amended

preliminary injunction order, which reaffirmed that

OCBC was preliminarily enjoined from manufacturing,

distributing, or possessing marijuana with the intent to

manufacture or distribute it, in violation of 21-U.S.C.

841(a)(1). App. 15a-16a. The district court further

ordered, however, that

[t]he foregoing injunction does not apply to the dis-

tribution of cannabis by [OCBC] to patient-members

who (1) suffer from a serious medical condition, (2)

will suffer imminent harm if the patient-member

does not have access to cannabis, (3) need cannabis

for the treatment of the patient-member’s medical

condition, or need cannabis to alleviate the medical

condition or symptoms associated with the medical

condition, and (4) have no reasonable legal alterna-

tive to cannabis for the effective treatment or alle-

viation of the patient-member’s medical condition or

symptoms associated with the medical condition be-

cause the patient-member has tried all other legal

alternatives to cannabis and the alternatives have

been ineffective in treating or alleviating the pa-

tient-member’s medical condition or symptoms as-

sociated with the medical condition, or the alterna-

tives result in side effects which the patient-mem-

ber cannot reasonably tolerate.

Id. at 16a-17a.

On July 18, 2000, the district court denied the gov-

ernment’s motion for a stay of the court’s July 17, 2000,

modification order pending appeal.

7

REASONS FOR GRANTING THE PETITION

The Ninth Circuit has held that medical necessity is a

“legally cognizable defense” to a charge of distributing

drugs in violation of the Controlled Substances Act.

App. 8a. The court has further held that district courts

have the “equitable discretion” to fashion an injunction

to permit an organization to engage in the ongoing

distribution of marijuana, wholly outside the strict

controls imposed by the CSA, to individuals claiming a

medical necessity for the drug. App. 10a.

The conclusion that a court may exempt certain

persons or transactions from the operation of the CSA,

based on the view of those persons or the court on

whether marijuana has some medical utility, cannot be

squared with the judgment Congress itself made in

placing marijuana in Schedule I, which applies to

substances that have been authoritatively found under

the CSA to have a “high potential for abuse,” “no cur-

rently accepted medical use in treatment in the United

States,” and “a lack of accepted safety for use * * *

under medical supervision.” 21 U.S.C. 812(b)(1). Nor

can the court of appeals’ decision be squared with Con-

gress’s recent statutory declaration that it “continues

to support the existing Federal legal process for deter-

mining the safety and efficacy of drugs and opposes

efforts to circumvent this process by legalizing mari-

juana, and other Schedule I drugs, for medicinal use

without valid scientific evidence and the approval of the

Food and Drug Administration.” Pub. L. No. 105-277,

Div. F, 112 Stat. 2681-760 to 2681-761. Congress has

assigned to the Attorney General and the Secretary of

Health and Human Services, under prescribed stan-

dards and administrative procedures set forth in the

CSA, the responsibility to determine whether the

8

manufacture and distribution of marijuana and other

drugs should be permitted for specified medical pur-

poses. It has not left that determination to individual

courts or juries—much less to private organizations like

the Oakland Cannabis Buyers’ Cooperative.

Whether asserted medical necessity exempts the

distribution of marijuana (and other drugs) from strict

controls under the CSA is an issue of exceptional and

continuing importance. By sanctioning the prospective

distribution of marijuana under a common law defense

of necessity, the Ninth Circuit’s holding flouts the

provisions of the CSA banning the distribution of

marijuana outside strictly controlled circumstances and

undermines the enforcement of the federal drug laws.

It also opens the way for producers, distributors, or

users of other drugs and devices not approved by the

FDA to invoke “medical necessity” as a defense to

enforcement of the nation’s health and safety laws.

The court of appeals’ decision therefore warrants this

Court’s review.

1. a. The court of appeals seriously erred in holding

that medical necessity is a defense under the CSA, and

in further holding that a district court has the equitable

discretion to fashion an injunction that would permit

the distribution of marijuana for medicinal purposes

wholly outside the strict regulatory regime of the CSA.

A common law defense of necessity is available only

“when a real legislature would formally do the same

under those circumstances.” United States v. Schoon,

971 F.2d 198, 197 (9th Cir. 1991), cert. denied, 504 U.S.

990 (1992). See also 1 Walter LaFave & Austin W.

Scott, Jr., Substantive Criminal Law § 5.4, at 629 (1986)

(“The defense of necessity is available only in situations

wherein the legislature has not itself, in its criminal

ee

9

statute, made a determination of values. If it has done

so, its decision governs.”).

The text, structure, and purposes of the CSA all

compel the conclusion that Congress expressly has

rejected the notion that an individual who claims a

medical necessity for marijuana is exempted from the

Act’s prohibitions on the manufacture, distribution, or

dispensing of marijuana. The text of the CSA makes it

unlawful to “manufacture, distribute, or dispense, or

possess with intent to manufacture, distribute, or dis-

pense’” any controlled substance, “({e]xcept as author-

ized by [21 U.S.C. 801-904].” 21 U.S.C. 841(a)(1); see

also United States v. Moore, 423 U.S. 122, 131, 135

(1975). Since the enactment of the CSA in 1970,

marijuana has been classified as a Schedule I controlled

substance, a classification which means that marijuana

has been found to have a “high potential for abuse,” “no

currently accepted medical use in treatment in the

United States,” and “a lack of accepted safety for use

* * * under medical supervision.” 21 U.S.C. 812(b)(1).

The CSA also establishes a closed system of dis-

tribution for Schedule I controlled substances. No phy-

sician or pharmacy may dispense a Schedule I con-

trolled substance to any patient outside ofa strictly

controlled research project that has been registered

with the Drug Enforcement Administration (DEA) and

approved by the Food and Drug Administration (FDA).

21 U.S.C. 823(f); 21 C.F.R. 5.10(a)(9), 1801.18 and

1301.32; 28 C.F.R. 0.100(b). By contrast, physicians and

pharmacies may lawfully distribute controlled sub-

stances in Schedules II through V consistent with their

DEA registration. 21 U.S.C. 829. Even for substances

listed in Schedules II through V, however, the Act does

not allow the essentially unregulated manufacture and

distribution that the Ninth Circuit has countenanced

10

for marijuana, a Schedule I controlled substance. See

21 U.S.C. 822-829.

In addition, the CSA establishes an exclusive set of

statutory procedures under which controlled sub-

stances that have been placed in Schedule I (or any

other schedule) may be transferred between, or re-

moved from, the five schedules, based on changes in

scientific knowledge. 21 U.S.C. 81l(a). Pursuant to

that process, “any interested party” who believes that

medical, scientific, or other relevant data warrant

transferring marijuana to a less restrictive schedule

may petition the Administrator of the DEA to initiate a

rulemaking proceeding to reschedule marijuana. 21

U.S.C. 811(a); 21 C.F.R. 1308.43. The Administrator,

acting on behalf of the Attorney General, must refer

any rescheduling petition to the Secretary of Health

and Human Services for a medical and scientific

evaluation, which is binding on the Administrator. 21

U.S.C. 811(b). Any party aggrieved by a final decision

of the Administrator may seek review in the court of

appeals. 21 U.S.C. 877; see, e.g., Alliance for Cannabis

Therapeutics v. DEA, 15 F.3d 11381, 1137 (D.C. Cir.

1994) (upholding Administrator’s decision declining to

remove marijuana from the list of Schedule I controlled

substances). Based on that framework, the courts of

appeals uniformly have held that the statutory re-

scheduling process is the exclusive means by which to

challenge marijuana’s placement in Schedule I.°

6 United States v. Burton, 894 F.2d 188, 192 (6th Cir.), cert.

denied, 498 U.S. 857 (1990); United States v. Greene, 892 F.2d 453,

455-456 (6th Cir. 1989), cert. denied, 495 U.S. 935 (1990); United

States v. Wables, 731 F.2d 440, 450 (7th Cir. 1984); United States v.

Fogarty, 692 F.2d 542, 548 (8th Cir. 1982), cert. denied, 460 U.S.

1040 (1983); United States v. Middieton, 690 F.2d 820, 823 (11th

_

a

11

Finally, in a statutory provision enacted in 1998 and

entitled “NOT LEGALIZING MARIJUANA FOR

MEDICINAL USE,” Congress declared that:

(1) certain drugs are listed on Schedule I of the

Controlled Substances Act if they have a high

potential for abuse, lack any currently accepted

medical use in treatment, and are unsafe, even

under medical supervision;

* * * * *

(3) pursuant to section 401 of the Controlled

Substances Act, it is illegal to manufacture, distri-

bute, or dispense marijuana * * *;

(4) pursuant to section 505 of the Federal

Food, Drug and Cosmetic Act, before any drug can

be approved as a medication in the United States, it

must meet extensive scientific and medical stan-

dards established by the Food and Drug Admini-

stration to ensure it is safe and effective;

(5) marijuana and other Schedule I drugs have

not been approved by the Food and Drug Ad-

ministration to treat any disease or condition;

(6) the Federal Food, Drug and Cosmetic Act

already prohibits the sale of any unapproved drug,

including marijuana, that has not been proven safe

and effective for medical purposes and grants the

Food and Drug Administration the authority to

enforce this prohibition through seizure and other

civil action, as well as through criminal penalties;

Cir. 1982), cert. denied, 460 U.S. 1051 (1983); United States v.

Kiffer, 477 F 2d 349, 357 (2d Cir.), cert. denied, 414 U.S. 831 (1973).

12

* * * * *

(11) Congress continues to support the existing

Federal legal process for determining the safety and

efficacy of drugs and opposes efforts to circumvent

this process by legalizing marijuana, and other

Schedule I drugs, for medicinal use without valid

scientific evidence and the approval of the Food and

Drug Administration.

Pub. L. No. 105-277, Div. F, 112 Stat. 2681-760 to

2681-761 (reprinted at App. 89a-92a).’ That legislation

reaffirms Congress’s continuing adherence to the

existing FDA drug-approval process, and its continuing

opposition to any effort to allow the medicinal use of

marijuana or other Schedule I controlled substances

until they are proven safe and effective based on ap-

propriate findings by the FDA. See, e.g., Accardi v.

Pennsylvania R.R. Co., 383 U.S. 225, 229 (1966) (con-

tinuing purpose of Congress reflected in “sense of Con-

gress” enactment); Harris v. United States, 359 U.S. 19,

22 n.8 (1959) (continuing purpose of Congress reflected

in subsequently-enacted legislation).

Those provisions leave no doubt that, had Congress

considered whether an individual claiming a medical

need for marijuana could violate the CSA with

impunity, Congress would have answered the question

7 The legislation was prompted by state initiatives around the

country to legalize marijuana for medicinal uses. The provision’s

sponsor, Representative McCullom, explained that the provision

“is important” because, inter alia, “[mJore than 30 States and the

District of Columbia have been targeted for possible medical

marijuana initiatives,” and that such initiatives “have already been

passed in California and Arizona.” 144 Cong. Rec. H7720 (daily ed.

Sept. 15, 1998); see also 144 Cong. Rec. S10,666 (daily ed. Sept. 21,

1998).

13

with a resounding “no.” Yet in recognizing the avail-

ability of a medical necessity defense, the court of

appeals has sanctioned the use of marijuana for

medicinal purposes. That decision is directly at odds

with Congress’s express finding that marijuana has “no

currently accepted medical use.” 21 U.S.C. 812(b)(1).

It also is inconsistent with the exclusive procedures

under the CSA for the removal of marijuana from the

list of Schedule I controlled substances in order to allow

its use for medical purposes under specified conditions.

21 U.S.C. 811; cf. United States v. Bailey, 444 U.S. 394,

410 (1980) (noting that a necessity defense is

unavailable “if there was a reasonable, legal alternative

to violating the law”).

Finally, the recognition of a medical necessity

defense runs counter to the absolute ban on the distri-

bution of marijuana and other Schedule I controlled

substances outside a DEA-registered and FDA-

approved research project. 21 U.S.C. 823(f); see also 21

U.S.C. 841(a)(1) (making the distribution and dis-

pensing of controlled substances unlawful “[e]xcept as

authorized” by the CSA); United States v. Moore, 423

U.S. at 131. Indeed, the Ninth Circuit’s decision

permits the distribution of marijuana under judicial

imprimatur without any of the stringent limitations

that Congress placed on the manufacture and distri-

bution of controlled substances, even those listed in

Schedules II through V. The CSA and the governing

regulations require manufacturers, distributors, and

dispensers of controlled substances to register with the

DEA, 21 U.S.C. 822(a), 823, 21 C.F.R. 1301, and to

establish effective controls to guard against the theft

and diversion of controlled substances, 21 C.F.R.

1301.71-1301.76; authorize the Attorney General to

inspect a registrant’s establishment, 21 U.S.C. 822(f),

14

880; require the Attorney General to determine pro-

duction quotas for Schedule I and II controlled sub-

stances, 21 U.S.C. 826, 21 C.F.R. 1303; impose

substantial record-keeping and reporting requirements

_ on registrants, 21 U.S.C. 827, 21 C.F.R. 1304; disallow

the distribution of Schedule I and II drugs except

pursuant to an order form issued by the DEA, 21

U.S.C. 828, 21 C.F.R. 1805; and establish prescription

requirements for the dispensing of controlled sub-

stances in Schedules II through V, 21 U.S.C. 829, 21

C.F.R. 1306. The Ninth Circuit’s recognition of a

medical necessity defense cannot be squared with

Congress’s considered judgment that the threat to

public health and safety mandates a complete ban on

the manufacture and distribution of controlled

substances outside the express terms of the CSA.

In United States v. Rutherford, 442 U.S. 544 (1979),

this Court considered an analogous issue and held that

a claim of medical need for a drug cannot override Con-

gress’s judgment that the drug not be distributed

absent a finding by the FDA under the statutory

framework that the drug is generally recognized by

experts as safe and effective. In Rutherford, a class of

terminally ill cancer patients and their spouses brought

suit to enjoin the government from interfering with the

interstate shipment and sale of Laetrile, a drug that

had not been approved by the FDA under the Food,

Drug, and Cosmetic Act (FDCA). The district court

granted the requested relief, and the Tenth Circuit

affirmed, holding that the safety and effectiveness

protections of the FDCA had no reasonable application

to terminally ill cancer patients since those patients, by

definition, would die of cancer regardless of their

treatment. Id. at 548-549. The Court unanimously

reversed. The Court rejected the Tenth Circuit’s

15

determination that an exemption from the FDCA was

justified because the safety and effectiveness standards

could have no reasonable application to terminally ill

cancer patients, explaining that, “[u]nder our constitu-

tional framework, federal courts do not sit as councils of

revision, empowered to rewrite legislation in accord

with their own conceptions of prudent public policy.

* * * Whether, as a policy matter, an exemption

should be created is a question for legislative judgment,

not judicial inference.” Jd. at 555, 559. The Court also

reasoned that the FDCA “makes no special provision

for drugs used to treat terminally ill patients,” and that

“(when construing a statute so explicit in scope,” it is

incumbent upon courts to give it effect. Jd. at 551.

The Court’s holding and reasoning in Rutherford

apply with equal force to the CSA, whose text, struc-

ture, and paramount policies evince Congress’s intent

to ban the distribution of marijuana, even for medicinal

purposes. Indeed, every court to have considered the

issue has rejected the invocation of a medical necessity

defense under the CSA. See United States v. Burton,

894 F.2d 188, 191 (6th Cir.) (concluding the defense

was not available because the defendant could have

attempted to participate in a government-approved

program to study the effects of marijuana on glaucoma

sufferers), cert. denied, 498 U.S. 857 (1990); United

States v. Belknap, No. 92-5363, 1993 WL 30375, at **2

(4th Cir. Feb. 10, 1993) (unpublished) (concluding that

there was “no legal or factual basis” for a medical

necessity defense to marijuana prosecution); United

States v. McWilliams, No. CR 97-997(A)-GHK (C.D.

Cal. Nov. 5, 1999), slip op. 2-3 (“Because Congress has

already determined that there is no accepted medical

use for marijuana, * * * we conclude as a matter of

law that the medical necessity defense is not available

16

in this case.”); United States v. Lederer, No. CR-97-558

GEB (E.D. Cal. May 21, 1999), slip op. 5-9 (“Since the

weighing of values required for the defense of necessity

has already been conducted by Congress’ proscription

of the very acts [the defendant] sought to legitimize

through his assertion of the defense, [the defendant’s]

motion is denied.”); United States v. Diana, No. CR-98-

068-RHW (E.D. Wash. Sept. 21, 1998), slip op. 5

(rejecting medical necessity defense because “Congress

was aware of the competing interests in cases such as

Defendants’ and addressed them”); United States v.

Allerheilgen, No. 97-40090-01-DES, 1998 WL 918841

(D. Kan. Nov. 19, 1998) (same).*

b. In reaching the contrary holding that medical

necessity is a “legally cognizable defense,” the court of

appeals did not attempt to reconcile a medical necessity

defense with either the text of the CSA or the 1998

legislation disapproving any attempt to legalize mari-

juana for medicinal use outside the existing framework

8 State courts that have construed state drug laws are divided

on whether a medical necessity defense is available in a marijuana

prosecution under those laws. Eight state courts have held that

the defense is unavailable. State v. Poling, No. 26658, 2000 WL

572334, *7-*8 (W. Va. May 8, 2000); State v. Ownbey, 996 P.2d 510

(Or. Ct. App. 2000); State v. Williams, 968 P.2d 26 (Wash. Ct. App.

1998), review denied, 984 P.2d 1034 (1999); Murphy v. Common-

wealth, 521 S.E.2d 301, 302-303 (Va. Ct. App. 1999); State v. Tate,

505 A.2d 941, 946 (N.J. 1986); State v. Cramer, 851 P.2d 147, 149

(Ariz. Ct. App. 1992); Kauffman_y. State, 620 So. 2d 90, 92-93 (Ala.

Crim. App. 1992); State v. Hanson, 468 N.W.2d 77, 78 (Minn. Ct.

App. 1991). By contrast, four state courts have recognized the

availability of the defense. See State v. Bachman, 595 P.2d 287,

288 (Haw. 1979); State v. Hastings, 801 P.2d 563, 565 (Idaho 1990);

Jenks v. State, 582 So. 2d 676, 678-679 (Fla. Dist. Ct. App.), review

denied, 589 So. 2d 292 (1991); State v. Christen, 704 A.2d 335, 337

(Me. 1997).

17

of the CSA and the FDCA. Rather, the court of

appeals explained that it saw “no indication that the

‘underlying substantive policy’ of the [CSA]'‘mandates a

limitation on the district court’s equitable powers” “to

formulate appropriate relief when and if injunctions are

sought.” App. 9a. The court of appeals took the view

that the district court abused its discretion first in

failing to consider what it deemed the “strong public

interest” in the availability of marijuana for medicinal

purposes, and second in finding that an injunction

against marijuana distribution could not be supported

by the government’s “general interest in enforcing its

statutes.” Jd. at 9a, lla.

Those conclusions, however, cannot be reconciled

with this Court’s precedents concerning the limits of a

district court’s equitable discretion in fashioning an

injunction. This Court has long held that a district

court sitting in equity cannot “ignore the judgment of

Congress” that is “deliberately expressed in legisla-

tion.” Virginia Ry. Co. v. System Fed’n No. 40, 300

US. 515, 551 (1937). Likewise, in Hecht Co. v. Bowles,

321 U.S. 321, 331 (1944), the Court held that, where

injunctive relief is sought pursuant to a statutory

mandate, a court’s equitable discretion must reflect the

“large objectives” of the statute, “[flor the standards of

the public interest, not the requirements of private

litigation, measure the propriety and need for injunc-

tive relief.” This principle was reaffirmed in TVA v.

Hill, 437 U.S. 158, 194 (1978), in which the Supreme

Court held that, in examining whether to enter injunc-

tive relief, a court must be mindful that

itis * * * emphatically * * * the exclusive

province of the Congress not only to formulate

legislative policies and mandate programs and

18

projects, but also to establish their relative priority

for the Nation. Once Congress, exercising its dele-

gated powers, has decided the order of priorities in a

given area, it is for the Executive to administer the

laws and for the courts to enforce them when

enforcement is sought.

See also Miller v. French, No. 99-224 (June 19, 2000),

slip op. 11.

Those principles dictate the conclusion that a district

court lacks the discretion, based on its own perception

of the public interest and its own weighing of possible

medical benefits against the potential for abuse, to craft

an injunction under the CSA which exempts from the

injunction’s reach the distribution of marijuana for

medicinal purposes. Congress already has considered

the public interest, balanced the relevant medical and

other considerations, and concluded that, unless and

until the DEA removes marijuana from Schedule I, the

drug has no “accepted medical use” and a “high poten-

tial for abuse” (21 U.S.C. 812(b)(1)) and may not be

manufactured, distributed, or dispensed outside of a

program of research approved by the FDA and con-

ducted by a practitioner registered with the DEA (21

U.S.C. 841(a), 823(f)). The Ninth Circuit therefore

plainly erred in holding that a district court has the

equitable discretion to modify its injunction based on a

claimed public interest in distributing marijuana to

those who claim to have a medical need for it.

2. a. The issue of whether the CSA forecloses the

availability of a medical necessity defense is one of

exceptional and continuing importance. For the first

time, a court of appeals has ruled that persons and enti-

ties may lawfully engage in the distribution of mari-

juana if, in their view, the recipients of the marijuana

19

medically need the drug. That holding flouts the CSA’s

ban on the distribution of Schedule I controlled sub-

stances unless the distributor is registered with the

DEA and conducting research approved by the FDA.

See 21 U.S.C. 823(f). The court of appeals’ decision

likewise circumvents the Act’s exclusive provisions for

drug approval and rescheduling of controlled sub-

stances. See 21 U.S.C. 811, 812. And the decision rele-

gates to district courts and juries the power to deter-

mine whether illicit drugs can be used safely and

effectively as medicine, even though Congress in the

CSA placed such determinations within the province of

the Attorney General and the Secretary of Health and

Human Services. Thus, the Ninth Circuit’s decision

seriously undermines the administration and effective-

ness of the CSA.

The decision is also significant because it threatens

the government’s ability to enforce the federal drug

laws in the nine States within the Ninth Circuit, which

comprises a population of nearly 50 million people. U.S.

Dep’t of Commerce, Statistical Abstract of the United

States (1994). Indeed, the Ninth Circuit’s sanctioning of

the distribution of controlled substances in a manner

that the CSA expressly prohibits creates incentives for

drug manufacturers and distributors involved in a wide

variety of offenses involving marijuana (and other

Schedule I controlled substances, such as heroin or

LSD) to invoke medical necessity as a defense to their

alleged drug trafficking. The recognition of such a

defense will introduce illegitimate collateral issues into

drug prosecutions and will consume unnecessary

judicial resources by distracting the trier of fact from

the core issues of guilt or innocence of a particular

crime as defined by Congress in the CSA.

20

For example, in a recent case prosecuted in the

Eastern District of California, a motions panel of the

Ninth Circuit reversed a district court’s order denying

bail pending appeal, holding that, in view of the Ninth

Circuit’s decision in this case, the defendant, a dis-

tributor of marijuana, was “entitled to bail pending

appeal if he can demonstrate: 1) a likelihood that he

was entitled to present a medical necessity defense at

trial; and 2) his release does not pose a danger that he

will distribute marijuana to people not falling within

the class of individuals described in OCBC.” United

States v. Smith, No. 99-10447 (9th Cir. Feb. 3, 2000),

slip op. 1-2.

The court of appeals’ recognition of a medical neces-

sity defense also takes on added significance in light of

the fact that a number of States in the Ninth Circuit—

Alaska, California, Hawaii, Oregon, and Washington—

have enacted legislation sanctioning the use of mari-

juana for medicinal purposes. See Alaska Stat.

§§ 17.37.010-17.37.080 & 11.71.090 (1999); Cal. Health &

Safety Code § 11862.5(b)(1)(A) and (d); Haw. S.B. 862,

20th Legis. (1999) (signed into law on July 12, 2000); Or.

Rev. Stat. §§ 475.300-475.346 (1999); Wash. Rev. Code

§§ 69.51.010-69.51.080 (1997).° In those States, there is

therefore no state law that would independently bar

® A medical marijuana ballot measure likewise was approved

by voters in Maine in November 1999. Carey Goldberg, Maine

Mulls Medical Use for its Seized Marijuana, N.Y. Times, Mar. 14,

2000 at Nat’l Desk. We have been informed by the DEA that

medical marijuana initiatives are underway in Arizona, Nevada,

Colorado, Iowa, Maryland, Massachusetts, Minnesota, New

Hampshire, and New York. A majority of voters in the District of

Columbia also approved a marijuana initiative in November 1998,

but Congress blocked implementation of that initiative. See 145

Cong. Rec. H12,238 (daily ed. Nov. 17, 1999).

21

the distribution of marijuana in the circumstances that

the Ninth Circuit has sanctioned. Thus, unless the CSA

can be enforced with respect to that distribution, drug

traffickers, acting under the guise of “medical

necessity,” will be able to manufacture and distribute

marijuana with impunity, even though the CSA reflects

Congress’s deliberate judgment that marijuana shall

not be used for medicinal purposes outside the specific

confines of the Act itself.

Finally, the Ninth Circuit’s decision threatens the

government’s more general ability to enforce the fed-

eral drug laws with respect to other illegal and un-

approved drugs. As this Court recognized in Ruther-

ford:

It bears emphasis that although the Court of

Appeals’ ruling was limited to Laetrile, its rea-

soning cannot be so readily confined. To accept the

proposition that the safety and efficacy standards of

the Act have no relevance for terminal patients is to

deny the Commissioner’s authority over all drugs,

however toxic or ineffectual, for such individuals. If

history is any guide, this new market would not be

long overlooked.

442 U.S. at 557-558. That reasoning is equally applica-

ble in this case. Under the Ninth Circuit’s analysis,

there is no reason that a defendant charged with of-

fenses involving other Schedule I controlled substances

or unapproved drugs—such as Laetrile—would not

similarly be able to raise the defense of “medical

necessity.” The Ninth Circuit’s decision therefore

could significantly undermine the enforcement of the

federal drug laws and the FDA drug-approval process,

a result patently at odds with the statutory framework

22

that Congress has enacted. The court of appeals’ -

decision therefore warrants this Court’s review.

b. No further proceedings in the lower courts are

needed to clarify the issues presented or to render the

case suitable for resolution by this Court. As explained

above, the Ninth Circuit held: (a) that medical neces-

sity is a “legally cognizable defense” to a marijuana

prosecution or a suit for an injunction against marijuana

distribution, App. 8a; (b) that OCBC had “identified a

strong public interest in the availability of a doctor-

prescribed treatment [of marijuana] that would help

ameliorate the condition and relieve the pain and

suffering of a large group of persons with serious or

fatal illnesses,” id. at 9a-10a; and (c) that the

government, which had “rel[ied] exclusively on its

general interest in enforcing its statutes,” had identi-

fied no “interest * * * in blocking the distribution of

marijuana to those with medical needs,” id. at lla. To

be sure, the court of appeals did not order the injunc-

tion modified to permit the distribution of marijuana,

but rather referred the case to the district court for a

determination whether the injunction should be

modified in that respect. On remand, however, the

district court granted OCBC’s request to modify the

injunction, and did so “in light of the Ninth Circuit’s

opinion. ” Jd. at 13a. Thus, no further factual develop-

ment is needed for this Court to resolve the legal issues

presented.

Moreover, there is no reason to await an appeal of the

district court’s modification order in order to clarify the

question presented. Although the government has filed

a notice of appeal from the district court’s July 17, 2000,

order modifying the injunction, there is no reason to

believe that the Ninth Circuit panel, which has retained

jurisdiction over any appeal, App. lla, will revisit its

23

fundamental holding that medical necessity is a legally

cognizable defense that justifies violating the CSA—

especially since the Ninth Circuit declined to reconsider

that holding on the government’s petition for rehearing

and rehearing en banc.

Finally, with respect to the circumstances of this

case, the court of appeals has already determined that

“(t]he evidence in the record is sufficient to justify the

requested modification.” App. 10a. Indeed, the court of

appeals stated that it had “no doubt that the district

court could have modified its injunction, had it deter-

mined to do so in the exercise of its equitable discre-

tion.” Ibid. Given the terms of the court of appeals’

remand, and the district court’s actual modification of

the injunction, further proceedings are unlikely to

assist this Court in its review of the basic legal issues

presented. And at the same time, to postpone review of

the Ninth Circuit’s holding would only exacerbate its

adverse consequences by encouraging broad disregard

of the Controlled Substances Act and the unregulated

distribution of marijuana, with the attendant serious

potential for abuse Congress sought to prevent by

placing marijuana in Schedule I under the Act.

24

CONCLUSION

The petition for a writ of certiorari should be

granted.

Respectfully submitted.

SETH P. WAXMAN

Solicitor General

DAVID W. OGDEN:

Acting Assistant Attorney

General

EDWIN S. KNEEDLER

Deputy Solicitor General

LISA SCHIAVO BLATT

Assistant to the Solicitor

General

JULY 2000