No. 00-151 

In the Supreme Court of the United States 

UNITED STATES OF AMERICA, PETITIONER 

v. 

OAKLAND CANNABIS BUYERS’ COOPERATIVE 
AND JEFFREY JONES 

ON WRIT OF CERTIORARI 
TO THE UNITED STATES COURT OF APPEALS 
FOR THE NINTH CIRCUIT 

BRIEF FOR THE PETITIONER 

SETH P. WAXMAN 

Solicitor General 

Counsel of Record 

DAVID W. OGDEN 

Assistant Attorney General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

LISA SCHIAVO BLATT 

Assistant 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 seq., forecloses a “medical necessity” defense to 
the Act’s prohibition against manufacturing and 
distributing marijuana, a schedule I controlled sub- 
stance. 

(I) 

TABLE OF CONTENTS 

Page 

Opinions below ............................................................................... 
1 

Jurisdiction ...................................................................................... 1 

Statutory provisions involved ..................................................... 
2 

Statement ........................................................................................ 2 

Summary of argument .................................................................. 
12 

Argument ........................................................................................ 16 

The Controlled Substances Act forecloses a 

“medical necessity” defense in both criminal and 

civil proceedings under the Act ........................................... 
16 

A. The CSA’s text, structure, and policies bar 

a “medical necessity” defense to a charged 

criminal violation of the Act .......................................... 

17 

B. Courts lack the equitable discretion under the 

CSA to permit the unauthorized distribution of 

marijuana to persons who assert a medical 

necessity to use it ............................................................ 

37 

Conclusion ....................................................................................... 43 

TABLE OF AUTHORITIES 

Cases: 

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

(1966) ........................................................................................ 26 

Albemarle Paper Co. v. Moody, 422 U.S. 405 

(1975) ........................................................................................ 37-38 

Alliance for Cannabis Therapeutics v. DEA, 

15 F.3d 1131 (D.C. Cir. 1994) ......................................... 

5, 32, 33 

Amoco Prod. Co. v. Village of Gambell, 480 U.S. 

531 (1987) ................................................................................. 

42 

Carnohan v. United States, 616 F.2d 1120 (9th 

Cir. 1980) ................................................................................. 

25 

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

26 

Hecht Co. v. Bowles, 321 U.S. 321 (1944) ................... 40, 41, 42 

(III) 

IV 

Cases—Continued: Page 

Kuromiya v. United States, 78 F. Supp. 2d 367 

(E.D. Pa. 1999) ........................................................................ 

36 

Miller v. French, 120 S. Ct. 2246 (2000) ............................ 

38, 40 

National Org. for the Reform of Marijuana Laws 

v. Bell, 488 F. Supp. 123 (D.D.C. 1980) ............................ 

4 

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

1152 (9th Cir. 1988) ................................................................ 

10, 37 

People ex rel. Lungren v. Peron, 70 Cal. Rptr. 2d 20 

(1997), review denied, No. AO77630 (Feb. 25, 1998) ....... 

Porter v. Warner Holding Co., 328 U.S. 395 

(1946) ........................................................................................ 39 

Rutherford v. United States, 616 F.2d 455 (10th 

Cir.), cert. denied, 449 U.S. 937 (1980) ............................... 

25 

Sinclair Ref. Co. v. Atkinson, 370 U.S. 195 

(1962) ........................................................................................ 38 

State v. Tate, 505 A.2d 941 (N.J. 1986) ............................... 

18 

Touby v. United States, 500 U.S. 160 (1991) ..................... 

4 

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

15, 38 

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

12, 17, 18, 

19, 20, 24, 34 

United States v. Burton, 894 F.2d 188 (6th Cir.), 
cert. denied, 498 U.S. 857 (1990) ......................................... 

24 

United States v. Burzynski Cancer Research Inst., 

819 F.2d 1301 (5th Cir. 1987), cert. denied, 484 

U.S. 1065 (1988) ...................................................................... 

25 

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

1982), cert. denied, 460 U.S. 1040 (1983) ........................ 24, 25-26 

United States v. Fry, 787 F.2d 903 (4th Cir.), 

cert. denied, 479 U.S. 861 (1986) ......................................... 

25 

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

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

24, 25 

United States v. Kabat, 797 F.2d 580 (8th Cir. 

1986), cert. denied, 481 U.S. 1030 (1987) ........................... 18 

V 

Cases—Continued: Page 

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

cert. denied, 414 U.S. 831 (1973) ......................................... 

24, 26 

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

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

24, 26 

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

2, 19, 21 

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

6, 15, 27- 

28, 33, 39 

United States v. Schoon, 971 F.2d 193 (9th Cir. 
1991), cert. denied, 504 U.S. 990 (1992) ............................. 

17 

United States v. Wables, 731 F.2d 440 (7th Cir. 

1984) ......................................................................................... 24 

Virginian Ry. v. System Fed’n No. 40, 300 U.S. 

515 (1937) .................................................................. 

15, 37, 40, 43 

Washington v. Glucksberg, 521 U.S. 702 

(1997) ........................................................................................ 25 

Weinberger v. Hynson, Westcott & Dunning, Inc., 

412 U.S. 609 (1973) ................................................................ 

6, 33 

Weinberger v. Romero-Barcelo, 456 U.S. 305 

(1982) ................................................................................ 

38, 40, 41 

Statutes and regulations: 

Act of Oct. 21, 1998, Pub. L. No. 105-277, Div. F, 

112 Stat. 2681-760 to 2681-761 ............................ 

2, 8, 15, 16, 26 

112 Stat. 2681-760 ..................................................... 

20, 30, 33 

112 Stat. 2681-761 ............................................................. 

27 

Controlled Substances Act, Pub. L. No. 91-513, 

Tit. II, 84 Stat. 1242 (21 U.S.C. 801 et seq.) ....................... 

2 

21 U.S.C. 801(2) ............................................. 

15-16, 19, 29, 39 

21 U.S.C. 801-904 .............................................................. 

2 

21 U.S.C. 802(6) ................................................................ 

2 

21 U.S.C. 802(16) .............................................................. 

4 

21 U.S.C. 811 ............................................................... 

4, 24, 35 

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

5 

21 U.S.C. 811(a)-(c) .......................................................... 

14 

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

5 

21 U.S.C. 811(c)(2) ............................................................ 31 

VI 

Statutes and regulations—Continued: 
Page 

21 U.S.C. 811(c)(3) ............................................................ 

31 

21 U.S.C. 812 ..................................................................... 

35 

21 U.S.C. 812(a) ................................................................ 

3 

21 U.S.C. 812(b) ................................................................ 

3 

21 U.S.C. 812(b)(1) ........................................................... 

20 

21 U.S.C. 812(b)(1)(A)-(C) .............................................. 

3 

21 U.S.C. 812(b)(1)(B) ....................................... 

13, 16, 29, 30 

21 U.S.C. 812(b)(1)(C) ...................................................... 

13, 16 

21 U.S.C. 812(b)(2)-(5) ..................................................... 

29 

21 U.S.C. 812(b)(2)(A) ..................................................... 

3 

21 U.S.C. 812(b)(2)(B) ................................................ 

3, 21, 31 

21 U.S.C. 812(b)(3)-(5) ..................................................... 

3 

21 U.S.C. 812(b)(3)(B) ................................................ 

3, 21, 31 

21 U.S.C. 812(b)(4)(B) ................................................ 

3, 21, 31 

21 U.S.C. 812(b)(5)(B) ................................................ 

3, 21, 31 

21 U.S.C. 812(c) (84 Stat. 1248-1252) ............................ 

3 

21 U.S.C. 812(c)(10) (84 Stat. 1249) ............................... 

3 

21 U.S.C. 812(c)(17) (84 Stat. 1249) ............................... 

3 

21 U.S.C. 821 ..................................................................... 

21 

21 U.S.C. 821-829 .................................................... 

3, 5, 14, 20 

21 U.S.C. 822(a) ................................................................ 

21 

21 U.S.C. 822(f) ................................................................. 

21 

21 U.S.C. 823 ..................................................................... 

21 

21 U.S.C. 823(f ) ..................................................... 

4, 13, 20, 36 

21 U.S.C. 824 ..................................................................... 

22 

21 U.S.C. 826 ..................................................................... 

21 

21 U.S.C. 827 ..................................................................... 

21 

21 U.S.C. 828(a) ................................................................ 

22 

21 U.S.C. 829 ..................................................................... 

22, 29 

21 U.S.C. 841-863 .............................................................. 
2 

21 U.S.C. 841(a)(1) ...................... 
2, 11, 13, 16, 17, 19, 35, 43 

21 U.S.C. 844(a) ................................................................ 

2, 35 

21 U.S.C. 877 ............................................................... 
5, 14, 24 

21 U.S.C. 880 ..................................................................... 
21 

21 U.S.C. 882(a) ......................................... 2, 8, 17, 37, 42, 43 

VII 

Statutes and regulations—Continued: 
Page 

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
301 et seq. ................................................................................. 
6 

21 U.S.C. 321(p) ................................................................ 
6, 26 

21 U.S.C. 355 ............................................................... 
7, 26, 30 

21 U.S.C. 355(a) ................................................................ 
6 

21 U.S.C. 355(b) ................................................................ 
6 

21 U.S.C. 355(d) ................................................................ 
6, 33 

21 U.S.C. 355(i) ....................................................... 
4, 6, 13, 20 

18 U.S.C. 751(a) ......................................................................... 
19 

California Compassionate Use Act of 1996, Cal. Health 
& Safety Code (West 1999): 
§ 11362.5(b)(1)(A) .............................................................. 
8 

§ 11362.5(d) ......................................................................... 
8 

21 C.F.R.: 

Pt. 5: 

Section 5.10(a)(9) ............................................................ 

4, 20 

Pt. 314: 

Section 314.126(e) ........................................................... 

33 

Pt. 1301: 

Sections 1301-1306 ........................................................... 

5 

Section 1301 ..................................................................... 
21 

Section 1301.18 ................................................................ 
4, 20 

Sections 1301.31-1301.37 ................................................. 
22 

Section 1301.32 ................................................................ 
4, 20 

Sections 1301.71-1301.76 ................................................. 
21 

Pt. 1303: 

Section 1303 ..................................................................... 

21 

Pt. 1304: 

Section 1304 ..................................................................... 

22 

Pt. 1305: 

Section 1305 ..................................................................... 

22 

Pt. 1306: 

Section 1306 ..................................................................... 

22 

28 C.F.R. 0.100(b) ...................................................................... 4, 5, 20 

VIII 

Miscellaneous: Page 

116 Cong. Rec. 1664 (1970) ...................................................... 
35 

144 Cong. Rec.: 

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

26 

p. S10,666 (daily ed. Sept. 21, 1998) ................................... 
26 

Daniel A. Farber, Equitable Discretion, Legal Duties, 
and Environmental Injunctions, 45 U. Pitt. L. 
Rev. 513 (1984) ....................................................................... 
38 

64 Fed. Reg. 35,928 (1999) ....................................................... 
36 

57 Fed. Reg. (1992): 

p. 10,499 ................................................................................... 

4, 31 

p. 10,500 ................................................................................... 
4 

pp. 10,500-10,505 .................................................................... 
32 

p. 10,505 ................................................................................... 
32 

p. 10,506 ................................................................................... 
32 

p. 10,507 ................................................................................... 
4, 32 

H.R. Rep. No. 1444, 91st Cong., 2d Sess. Pt. 1 
(1970) ..................................................................... 
4, 21, 22, 34, 35 

Institute of Medicine, Marijuana and Medicine: 

Assessing the Science Base (Janet E. Joy, et al. 
eds. 1999) ................................................................................. 

36 
Wayne R. LaFave & Austin W. Scott, Jr., Substantive 

Criminal Law (2d ed. 1986) ............................................ 
13, 17 

Model Penal Code (1962) ................................................. 
13, 17, 18 

National Comm’n on Marihuana and Drug Abuse, 

Marihuana: A Signal of Misunderstanding 
(Mar. 1972) .............................................................................. 34, 35 

In the Supreme Court of the United States 

No. 00-151 

UNITED STATES OF AMERICA, PETITIONER 

v. 

OAKLAND CANNABIS BUYERS’ COOPERATIVE 
AND JEFFREY JONES 

ON WRIT OF CERTIORARI 
TO THE UNITED STATES COURT OF APPEALS 
FOR THE NINTH CIRCUIT 

BRIEF FOR THE PETITIONER 

OPINIONS BELOW 

The opinion of the court of appeals (App. 1a-11a)1 is 
reported at 190 F.3d 1109. The May 13, 1998 memo- 
randum and order of the district court is reported at 5 
F. Supp. 2d 1086 (App. 41a-81a). The other opinions 
and orders of the district are unreported (App. 12a- 
40a). 

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, 

1 “App.” refers to the separately bound appendix to the peti- 
tion for a writ of certiorari. 

(1) 

2 

2000, Justice O’Connor extended the time within which 
to file a petition for a writ of certiorari to and including 
June 28, 2000. On June 19, 2000, Justice O’Connor 
further extended the time within which to file a petition 
to and including July 28, 2000, and the petition was filed 
on that date. The jurisdiction of this Court rests on 
28 U.S.C. 1254(1). 

STATUTORY PROVISIONS INVOLVED 

The relevant provisions of the Controlled Substances 
Act, 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. a. 

The Controlled Substances Act (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 
United States v. Moore, 423 U.S. 122, 131, 135 (1975).2 
The CSA imposes criminal and civil penalties for vio- 
lations of the Act, see 21 U.S.C. 841-863, and further 
gives district courts jurisdiction to enjoin violations of 
the Act. 21 U.S.C. 882(a). 

The CSA classifies controlled substances according to 
their inclusion in one of five schedules.3 The listing of a 
substance in one of the five schedules depends on the 
extent (if any) to which the particular drug has a cur- 

2 The CSA similarly makes it a crime to possess any controlled 
substance except as otherwise authorized by the Act. 21 U.S.C. 
844(a). 

3 The Act defines a “controlled substance” as “a drug or other 
substance, or immediate precursor, included in schedule I, II, III, 
IV, or V” of the Act. 21 U.S.C. 802(6). 

3 

rently accepted medical use, the level of its potential 
for abuse, and the degree of psychological or physical 
dependence to which its use may lead. 21 U.S.C. 812(b). 
The Act then imposes restrictions on the manufacture 
and distribution of the substance according to the 
schedule in which it has been placed. See 21 U.S.C. 821- 
829. 

A drug is included in schedule I, the most restrictive 
schedule, if it “has a high potential for abuse,” “has no 
currently accepted medical use in treatment in the 
United States,” and has “a lack of accepted safety for 
use * * * under medical supervision.” 21 U.S.C. 
812(b)(1)(A)-(C). A drug is included in schedule II if it 
“has a high potential for abuse,” but “has a currently 
accepted medical use in treatment in the United States” 
or “a currently accepted medical use with severe re- 
strictions.” 21 U.S.C. 812(b)(2)(A) and (B). Schedules 
III through V consist of drugs that similarly have “a 
currently accepted medical use in treatment in the 
United States,” 21 U.S.C. 812(b)(3)(B), (4)(B) and 
(5)(B), but have a lower potential for abuse and a more 
limited degree of dependence than drugs listed in the 
preceding schedule. 21 U.S.C. 812(b)(3)-(5). 

When it enacted the CSA in 1970, Congress specified 
certain substances to be included in each of the 
schedules as an initial matter. Pub. L. No. 91-513, Tit. 
II, § 202, 84 Stat. 1248-1252; see 21 U.S.C. 812(a). 
Congress classified marijuana and tetrahydrocannabi- 
nols as schedule I controlled substances from the 
outset, see 84 Stat. 1249 (schedule I(c)(10) and (17)), and 
they have remained schedule I substances ever since 
1970. See 21 U.S.C. 812(c) (schedule I(c)(10) and (17)).4 

4 “Marijuana (cannabis sativa L.) is a psychoactive drug made 
of the leaves, flowers, and stems of the Indian Hemp plant. It 

4 

The Attorney General may add other substances to the 
schedules if she finds, pursuant to procedures specified 
in the Act, that the drugs meet the statutory criteria. 
See 21 U.S.C. 811; Touby v. United States, 500 U.S. 160 
(1991). 

The CSA establishes “a ‘closed’ system of drug distri- 
bution” for all controlled substances. H.R. Rep. No. 
1444, 91st Cong., 2d Sess. Pt. 1, at 6 (1970); see also 
Moore, 423 U.S. at 141 (The CSA “authorizes transac- 
tions within ‘the legitimate distribution chain’ and 
makes all others illegal.”) (quoting H.R. Rep. No. 1444, 
supra, Pt. 1, at 3). No individual or entity may distri- 
bute or dispense a schedule I controlled substance ex- 
cept as part of a 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), 1301.18, 1301.32; 28 C.F.R. 0.100(b); 
see also 21 U.S.C. 355(i) (discussed at p. 6, note 5, 
infra). By contrast, drugs listed in schedules II 
through V may be dispensed and prescribed for medical 
use. Physicians, pharmacies, and other legitimate hand- 
lers of drugs listed in schedules II through V must, 
however, comply with stringent statutory and regula- 
tory provisions that mandate registration with the 
DEA, establish security controls, impose recordkeeping 

derives its psychoactive properties from delta-9-tetrahydro- 
cannabinol (THC), which exists in varying concentrations in the 
plant, depending on its origin, growing conditions, and cultivation.” 
National Org. for the Reform of Marijuana Laws v. Bell, 488 
F. Supp. 123, 128 (D.D.C. 1980) (three-judge court). In addition to 
THC, marijuana contains over 400 separately identified chemicals. 
57 Fed. Reg. 10,499, 10,500, 10,507 (1992). See also 21 U.S.C. 
802(16) (defining marijuana to mean “all parts of the plant Can- 
nabis sativa L”). 

5 

and reporting obligations, and permit the drug to be 
distributed and dispensed only pursuant to specified 
order-form and prescription requirements. See 21 
U.S.C. 821-829; 21 C.F.R. 1301-1306. 

The CSA also establishes an exclusive set of statu- 
tory procedures under which controlled substances that 
have been placed in schedule I (or any other schedule) 
may be transferred to another schedule or be entirely 
removed from the schedules. 21 U.S.C. 811(a). Pur- 
suant 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 Attorney General to initiate 
a rulemaking proceeding to reschedule marijuana. 21 
U.S.C. 811(a). Before initiating such proceedings, the 
Administrator of DEA, to whom the Attorney General 
has delegated her authority under the CSA (see 
28 C.F.R. 0.100(b)), must request from the Secretary of 
Health and Human Services (HHS) a scientific and 
medical evaluation and a recommendation as to 
whether the substance should be reclassified or decon- 
trolled. The recommendations of the Secretary are 
binding on the Administrator with respect to scientific 
and medical matters. 21 U.S.C. 811(b). If the 
Administrator concludes that there is substantial 
evidence that the substance should be rescheduled or 
decontrolled, he shall institute a public rulemaking 
proceeding on the record. 21 U.S.C. 811(b). Any party 
aggrieved by a final decision of the Administrator may 
seek review in the courts of appeals. 21 U.S.C. 877; see, 

e.g., Alliance for Cannabis Therapeutics v. DEA, 15 
F.3d 1131, 1137 (D.C. Cir. 1994) (upholding Admini- 
strator’s decision declining to transfer marijuana from 
schedule I to schedule II). 

6 

b. In addition to the restrictions under the CSA, 
marijuana is subject to the Federal Food, Drug, and 
Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Under the 
FDCA, “new” drug includes any drug that “is not 
generally recognized, among experts qualified by 
scientific training and experience to evaluate the safety 
and effectiveness of drugs, as safe and effective for use 
under the conditions prescribed, recommended, or 
suggested in the labeling thereof.” 21 U.S.C. 321(p); 
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 
U.S. 609, 629-632 (1973); United States v. Rutherford, 
442 U.S. 544, 546-548, 549-550 n.7 (1979). The FDCA 
prohibits the “introduc[tion] or deliver[y] for introduc- 
tion into interstate commerce” of a new drug, absent 
the submission of a new drug application (NDA) and a 
finding by the FDA that the drug is both safe and 
effective for each of its intended uses. 21 U.S.C. 355(a) 
and (b); Rutherford, 442 U.S. at 546.5 

The drug must be 
proven safe through “adequate tests by all methods 
reasonably applicable,” and it must be proven effective 
by “evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by ex- 
perts qualified by scientific training and experience to 
evaluate the effectiveness of the drug involved.” 21 
U.S.C. 355(d). 

c. In a statutory provision enacted in 1998 and 
entitled “NOT LEGALIZING MARIJUANA FOR 
MEDICINAL USE,” Congress declared that: 

5 The FDCA authorizes the Secretary to promulgate regula- 
tions for exempting from the new drug restrictions “ drugs in- 
tended solely for investigational use by experts qualified by scien- 
tific training and experience to investigate the safety and effec- 
tiveness of drugs.” 21 U.S.C. 355(i). 

7 

(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 [21 U.S.C. 355], 
before any drug can be approved as a medication in 
the United States, it must meet extensive scientific 
and medical standards established by the Food and 
Drug Administration to ensure it is safe and 
effective; 

(5) marijuana and other Schedule I drugs have 
not been approved by the Food and Drug Admini- 
stration 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; 

* * * * * 

(11) Congress continues to support the existing 
Federal legal process for determining the safety 
and efficacy of drugs and opposes efforts to circum- 

8 

vent 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. 

2. On January 9, 1998, the United States brought 
this suit in the United States District Court for the 
Northern District of California seeking an injunction 
against six marijuana distributors, popularly known as 
“cannabis clubs,” and ten associated individuals, alleg- 
ing that the defendants’ ongoing distribution (and in 
some cases manufacture) of marijuana violated the 
CSA. Many such groups formed in the wake of Cali- 
fornia’s Compassionate Use Act of 1996, or Proposition 
215, which purports to authorize under state law the 
possession and cultivation of marijuana for medical 
purposes upon a physician’s recommendation. See Cal. 
Health & Safety Code § 11362.5(b)(1)(A) and (d) (West 
1999).6 
On May 19, 1998, the district court issued a pre- 
liminary injunction under 21 U.S.C. 882(a) that enjoined 
respondents Oakland Cannabis Buyers’ Cooperative 
(OCBC) and its director and other marijuana distri- 
butors from “engaging in the manufacture or distri- 
bution of marijuana, or the possession of marijuana 
with the intent to manufacture and distribute mari- 

6 Proposition 215, however, neither authorizes the distribution 
of marijuana for medical purposes nor exempts such conduct from 
prosecution under California’s laws that criminalize the distribu- 
tion of marijuana. People v. Peron, 70 Cal. Rptr. 2d 20, 25-29 
(1997), review denied, No. A077630 (Feb. 25, 1998). Proposition 
215 also does not purport to displace any federal law applicable to 
marijuana. 

9 

juana, in violation of 21 U.S.C. § 841(a)(1).” App. 39a- 
40a (order); id. at 41a-81a (memorandum opinion). The 
court found it “undisputed that [respondents] distribute 
marijuana * * * to seriously ill patients or their 
primary caregivers for personal use by the patient upon 
a physician’s recommendation.” Id. at 63a. The court 
also rejected a variety of legal contentions offered by 
respondents to exempt themselves from the CSA’s 
prohibition against the manufacture and distribution of 
marijuana, including arguments based on a “medical 
necessity” theory. Id. at 68a-71a. The court noted that 
the “medical necessity” defense “has never been al- 
lowed to exempt a defendant from the criminal laws on 
a blanket basis.” Id. at 70a. 

Respondents did not appeal the injunction but rather 
violated it by openly distributing marijuana to numer- 
ous persons. App. 21a-23a. On October 13, 1998, the 
district court issued an order finding respondents in 
civil contempt. Id. at 20a-38a. On October 16, 1998, the 
district court issued an order denying respondents’ 
motion to modify or dissolve the injunction to include a 
broad exemption for distribution to persons claiming a 
“medical necessity” to smoke marijuana. Respondents’ 
motion had requested a ruling permitting them to dis- 
tribute marijuana to persons who obtained a physician’s 
certificate stating that they need marijuana to alleviate 
or treat a serious medical condition. See id. at 18a-19a 
(denying motion for modification); id. at 7a-8a, 28a-29a 
(describing proposed “medical necessity” defense). 

3. In a per curiam opinion, the court of appeals re- 
versed the district court’s denial of the motion to 
modify the injunction based on a physician’s statement 
of “medical necessity.” App. 1a-11a. The court of ap- 
peals held that the district court, in construing its 
equitable power to issue an injunction, erred in not 

10 

“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 indi- 
cation 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.” Id. at 9a (quoting 
Northern Cheyenne Tribe v. Hodel, 851 F.2d 1152, 1156 
(9th Cir. 1988)). 

The court of appeals further concluded that, in decid- 
ing whether to issue or modify the injunction, the 
district court abused its discretion in not considering 
what the court of appeals described as “a strong public 
interest in the availability of a doctor-prescribed treat- 
ment that would help ameliorate the condition and re- 
lieve the pain and suffering of a large group of persons 
with serious or fatal illnesses.” 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 respondents’ motion to modify the 
injunction to authorize respondents to distribute mari- 
juana. Id. at 10a. The court also expressed the view 
that “[t]he evidence 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 discretion.” Ibid. “[B]y contrast,” the 
court continued, the government had identified no 
“interest it may have in blocking the distribution of 
cannabis to those with medical needs, relying exclu- 
sively on its general interest in enforcing its statutes.” 
Id. at 11a. The court of appeals therefore remanded the 
matter to the district court “to reconsider” respon- 
dents’ request for a modification of the injunction to 

11 

exempt persons who have a medical need for marijuana. 
Ibid. 

4. 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 
cannabis 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 seriously 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 13a. The court therefore stated that, “[a]s a re- 
sult 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 
that modifying the injunction as requested is in the 
public interest and exercise its equitable discretion to 
do so.” Ibid. 

The district court accordingly issued an Amended 
Preliminary Injunction Order which reaffirmed that 
respondents are preliminary enjoined from manufac- 
turing or distributing marijuana, or possessing mari- 
juana 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 
distribution of cannabis by [respondents] to patient- 

12 

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 associ- 
ated with the medical condition, and (4) have no 
reasonable legal alternative to cannabis for the 
effective treatment or alleviation of the patient- 
member’s medical condition or symptoms associated 
with the medical condition because the patient- 
member has tried all other legal alternatives to 
cannabis and the alternatives have been ineffective 
in treating or alleviating the patient-member’s 
medical condition or symptoms associated with the 
medical condition, or the alternatives result in side 
effects which the patient-member cannot reasonably 
tolerate. 

Id. at 16a-17a.7 

SUMMARY OF ARGUMENT 

A. 1. A common law defense of “necessity” permits 
a court or jury to acquit a defendant of a criminal 
offense based upon a finding that the defendant acted to 
prevent an evil that is greater than that sought to be 
avoided by the legislature in criminalizing the conduct 
at issue. United States v. Bailey, 444 U.S. 394, 410 
(1980). The defense is not available, however, if the 
statute defining the criminal offense reflects a legis- 

7 On August 29, 2000, this Court entered an order granting 
the government’s application for a stay of the district court’s July 
17, 2000, orders, pending appeal of the order to the court of 
appeals. 121 S. Ct. 21. On December 12, 2000, the court of appeals 
postponed oral argument on that appeal pending this Court’s 
decision on writ of certiorari here. 

13 

lative resolution of the conflicting values at stake or 
other judgment that precludes the defense. Wayne R. 
LaFave & Austin W. Scott, Jr., Substantive Criminal 
Law § 5.4, at 627-629 (2d ed. 1986); Model Penal Code 
§ 3.02(1)(a) (1962). 

2. The text, structure and purposes of the Con- 
trolled Substances Act (CSA) establish a judgment by 
Congress that necessarily precludes a “necessity” 
defense to a charged violation of the Act based on an 
asserted medical need to smoke marijuana. By classify- 
ing marijuana as a schedule I controlled substance, 
Congress, in the text of the CSA itself, has declared 
that marijuana has no “currently accepted medical use 
in treatment in the United States” and has no “accepted 
safety for use * * * under medical supervision.” 21 
U.S.C. 812(b)(1)(B) and (C). Congress thus has banned 
the distribution of marijuana for any purpose, including 
purported medical use—“[e]xcept as authorized” by the 
Act itself (21 U.S.C. 841(a)(1)), i.e., unless the person 
dispensing the drug is a practitioner registered with 
the Drug Enforcement Administration to conduct re- 
search that has been specifically approved by the Food 
and Drug Administration (21 U.S.C. 355(i) and 823(f)). 
The CSA thus leaves no doubt that Congress has con- 
sidered the possibility of the medical use of marijuana 
and has specifically rejected it. 

3. A “medical necessity” defense also cannot be re- 
conciled with the provisions of the CSA that sub- 
stantially restrict and control the distribution and use 
of all controlled substances, even those that are listed in 
schedules II through V and that therefore have been 
determined to have an accepted medical use. The CSA 
requires legitimate handlers of all controlled substances 
to register with the DEA and follow recordkeeping and 
reporting obligations, and the Act further requires 

14 

manufacturers and distributors to use specified order 
forms when distributing schedule I or II controlled 
substances, and requires practitioners who dispense 
drugs to follow specified prescription requirements. 21 
U.S.C. 821-829. The Ninth Circuit’s decision counte- 
nances the ongoing distribution of marijuana without 
any of those stringent controls, and thus defeats the 
CSA’s purposes to protect the public from the dangers 
associated with the abuse of illicit drugs and their 
diversion from legitimate channels. 

4. The asserted defense of “medical necessity” like- 
wise is fundamentally inconsistent with the CSA’s 
provisions that govern the reclassification of controlled 
substances or their removal from scheduling altogether. 
Congress in the CSA assigned to the Attorney General, 
in consultation with the Secretary of HHS, the respon- 
sibility to decide whether to reclassify or remove mari- 
juana from schedule I, if she determines that the 
existing scientific and medical data support the con- 
clusion that marijuana no longer meets the statutory 
criteria of a schedule I drug. 21 U.S.C. 811(a)-(c). 
Congress also provided that any final decision by the 
Attorney General to retain or change the inclusion of 
marijuana in schedule I would be subject to review by a 
court of appeals, which must give conclusive effect to 
the Attorney General’s factual findings that are sup- 
ported by substantial evidence. 21 U.S.C. 877. Those 
provisions manifest a congressional intent to prevent 
organizations such as respondents from circumventing 
and subverting those procedures by attempting to 
persuade a district court or jury on a case-by-case basis 
whether the illegal distribution of marijuana is justified 
because of an asserted medical use for the drug. 

5. Finally, a “medical necessity” defense cannot be 
reconciled with the 1998 statute that Congress passed 

15 

in specific response to attempts by States to legalize 
marijuana use for medical purposes. That statute 
unambiguously expresses Congress’s continued ad- 
herence to the position that “marijuana * * * has not 
been proven safe and effective for medical purposes” 
and Congress’s insistence that marijuana may not be 
used for asserted medical purposes “without * * * the 
approval of the Food and Drug Administration” under 
the FDCA. 112 Stat. 2681-760 to 2681-761. 

B. A district court lacks the equitable discretion to 
craft an injunction that permits the distribution of 
marijuana for medical use in violation of the Act based 
on the court’s own view that such conduct furthers the 
public interest. A court sitting in equity cannot “ignore 
the judgment of Congress” that is “deliberately ex- 
pressed in legislation.” Virginian Ry. v. System Fed’n 
No. 40, 300 U.S. 515, 551 (1937); accord TVA v. Hill, 437 
U.S. 153, 194 (1978). This Court adhered to that rule in 
United States v. Rutherford, 442 U.S. 544 (1979), in 
holding that a district court lacked the power to enter 
an injunction that permitted the use of an unapproved 
drug, Laetrile, by terminally ill cancer patients. The 
Court reasoned that the FDCA “makes no special pro- 
vision for drugs used to treat terminally ill patients,” 
and that a court therefore may not override Congress’s 
policy choice that the drug not be distributed absent a 
finding by the FDA under the FDCA that the drug is 
safe and effective. Id. at 551. 

The CSA likewise “makes no special provision” for 
marijuana use to treat patients who claim that mari- 
juana is the only drug that will treat or alleviate their 
medical conditions. Congress already has determined 
that the illegal use and distribution of marijuana have 
“a substantial and detrimental effect on the health and 
general welfare of the American people,” 21 U.S.C. 

16 

801(2), and that marijuana has no “currently accepted 
medical use in treatment in the United States”; has no 
“accepted safety for use * * * under medical super- 
vision”; and is “unsafe, even under medical super- 
vision.” 21 U.S.C. 812(b)(1)(B) and (C); 112 Stat. 2681- 
760 to 2681-761. Congress therefore categorically has 
banned the unauthorized distribution of marijuana for 
all purposes, including purported medical uses, outside 
the strict controls established by the Act. 21 U.S.C. 
841(a)(1). A district court may not override those 
determinations by reweighing the scientific and medical 
data and social policies considered by Congress, the 
Attorney General, and the Secretary of Health and 
Human Services, and concluding that the public inter- 
est supports the illegal distribution of marijuana. 

ARGUMENT 

THE CONTROLLED SUBSTANCES ACT FORE- 
CLOSES A “MEDICAL NECESSITY” DEFENSE IN 
BOTH CRIMINAL AND CIVIL PROCEEDINGS 
UNDER THE ACT 

This case presents the question whether a defendant 
who violates the prohibitions in the Controlled Sub- 
stances Act (CSA) on the distribution of marijuana, a 
schedule I controlled substance, nonetheless may avoid 
liability under the Act based on a claim that the use of 
marijuana by the person to whom it is distributed is 
medically necessary. In recognizing the availability of a 
common law defense of “medical necessity” under the 
CSA, the court of appeals has sanctioned the ongoing 
distribution of marijuana for asserted medical purposes 
when such conduct otherwise would admittedly violate 
the Act. Indeed, the decision goes further and rele- 
gates to individual district courts and juries the power 

17 

to determine in individual cases brought by the govern- 
ment under the CSA whether and the manner in which 
marijuana can be distributed for an asserted medical 
use. As we explain below, however, Congress in the 
CSA has foreclosed a “medical necessity” defense, 
whether asserted in a criminal prosecution under 21 
U.S.C. 841(a)(1) or in a civil enforcement proceeding 
under 21 U.S.C. 882(a). 

A. The CSA’s Text, Structure, And Policies Bar A 

“Medical Necessity” Defense To A Charged Criminal 

Violation Of The Act 

1. The common law defense of “necessity” is often 
referred to as a “choice of evils” defense. The defense 
permits a court or jury to excuse a defendant’s criminal 
conduct if the defendant reasonably believes that the 
conduct was necessary to avert an evil or harm that is 
more serious than that sought to be prevented by the 
law defining the criminal offense charged. See United 
States v. Bailey, 444 U.S. 394, 410 (1980); Wayne R. 
LaFave & Austin W. Scott, Jr., Substantive Criminal 
Law § 5.4, at 627-629 (2d ed. 1986) (LaFave); Model 
Penal Code § 3.02(1)(a) (1962). 

A necessity defense has no application, however, in 
the face of a contrary legislative judgment that the 
criminal action is not justified by a claimed necessity to 
commit the prohibited act. “The defense of necessity is 
available only in situations wherein the legislature has 
not itself, in its criminal statute, made a determination 
of values. If it has done so, its decision governs.” La- 
Fave 629 (footnote omitted).8 Thus, “a legislative 

8 Stated differently, criminal conduct may be excused based 
on necessity only “when a real legislature would formally do the 
same under those circumstances.” United States v. Schoon, 971 
F.2d 193, 196-197 (9th Cir. 1991), cert. denied, 504 U.S. 990 (1992). 

18 

purpose to exclude the justification claimed [must] 
not otherwise plainly appear.” Model Penal Code 
§ 3.02(1)(c); see also id. (explanatory note) (“The legis- 
lature must not have previously foreclosed the choice 
that was made by resolving the conflict of values at 
stake.”); United States v. Kabat, 797 F.2d 580, 591-592 
(8th Cir. 1986) (“The necessity defense was never in- 
tended to excuse criminal activity by those who dis- 
agree with the decisions and policies of the lawmaking 
branches of government: in such cases the ‘greater 
harm’ sought to be prevented would be the course 
of action chosen by elected representatives.”), cert. 
denied, 481 U.S. 1030 (1987). Accordingly, the defense 
“cannot succeed” if “the legislature ha[s] itself can- 
vassed the issue and determined what the choice should 
be,” because “[t]he legislature, so long as it acts within 
constitutional limits, is always free to make such a 
choice and have its choice prevail.” Model Penal Code 
§ 3.02(1) (cmt. 2) (footnote omitted).9 

This Court applied those principles in United States 

v. Bailey, supra, in considering whether prisoners could 

9 The Supreme Court of New Jersey similarly has defined the 
limits of the necessity defense: 

In essence [the necessity defense] reflects a determination 

that if, in defining the offense, the legislature had foreseen the 
circumstances faced by the defendant, it would have created 
an exception. It would have balanced the competing values 
and chosen the lesser evil. Obviously, then, the defense is 
available at common law only when the legislature has not 
foreseen the circumstances encountered by a defendant. If it 
has in fact anticipated the choice of evils and determined the 
balance to be struck between the competing values, defendants 
and courts alike are precluded from reassessing those values to 
determine whether certain conduct is justified. 

State v. Tate, 505 A.2d 941, 946 (1986). 

19 

avoid criminal liability under 18 U.S.C. 751(a), which 
prohibits escape from the custody of the Attorney 
General, based on a defense that the escape was neces- 
sary to avoid unsafe prison conditions. The Court held 
that such a defense was unavailable in that case be- 
cause the prisoners had failed to surrender or return to 
custody as soon as the claimed conditions had lost their 
coercive force. 444 U.S. at 410-415. The Court 
reasoned that the recognition of a necessity defense in 
those circumstances would conflict with Section 751(a)’s 
purpose to guard against the continuing threat to 
society posed by an escaped prisoner. Id. at 412-413. 
The Court further explained that, although the common 
law defense “may well have been contemplated by 
Congress when it enacted [Section] 751(a), * * * some 
duty to return * * * must be an essential element of 
the defense unless the congressional judgment that 
escape from prison is a crime be rendered wholly 
nugatory.” Id. at 416 n.11. 

2. a. The CSA’s provisions leave no doubt that re- 
spondents in this case may not invoke a supposed 
“medical necessity” for individuals to smoke marijuana 
in certain circumstances to justify the ongoing distri- 
bution of marijuana in flagrant violation of the express 
terms of the CSA. Congress in the CSA has declared 
that “[t]he illegal * * * distribution[] and * * * 
improper use of controlled substances have a sub- 
stantial and detrimental effect on the health and 
general welfare of the American people.” 21 U.S.C. 
801(2). The CSA therefore makes it unlawful to “manu- 
facture, distribute, or dispense, or possess with intent 
to manufacture, distribute, or dispense” any controlled 
substance, “[e]xcept as authorized by” the Act itself. 21 
U.S.C. 841(a)(1); see United States v. Moore, 423 U.S. 
122, 131, 135 (1975). 

20 

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). In the 
1998 legislation entitled “NOT LEGALIZING MARI- 
JUANA FOR MEDICINAL USE,” Congress reiterated 
those findings, and reaffirmed its view that schedule I 
drugs are “unsafe, even under medical supervision,” 
and that the CSA makes it “illegal to manufacture, 
distribute, or dispense marijuana.” Pub. L. No. 105-277, 
Div. F, 112 Stat. 2681-760. Moreover, as a schedule I 
controlled substance, the CSA unequivocally provides 
that marijuana may not be dispensed to any individual 
outside of a strictly controlled research project that has 
been registered with the DEA and approved by the 
FDA. 21 U.S.C. 355(i), 823(f); 21 C.F.R. 5.10(a)(9), 
1301.18, 1301.32; 28 C.F.R. 0.100(b). 

Congress thus expressly has considered the possi- 
bility of the use of marijuana for medical purposes and 
has specifically rejected it. In those circumstances, to 
permit respondents to distribute marijuana for medical 
use would render Congress’s judgment to criminalize 
the unauthorized distribution of marijuana “wholly 
nugatory.” Bailey, 444 U.S. at 416 n.11. It is therefore 
inconceivable that Congress would have endorsed the 
illegal distribution of marijuana for medical purposes 
whenever such conduct was necessary to avert medical 
harm. 

b. The recognition of a “medical necessity” defense 
also cannot be reconciled with the stringent controls 
that Congress placed on all controlled substances, 21 
U.S.C. 821-829, even those drugs listed in schedules II 

21 

through V that have “a currently accepted medical use 
in treatment in the United States.” 21 U.S.C. 
812(b)(2)(B), (3)(B), (4)(B) and (5)(B) (emphasis added). 
The House Report explains that the CSA “provides for 
control * * * of problems related to drug abuse 
through registration of manufacturers, wholesalers, 
retailers, and all others in the legitimate distribution 
chain, and makes transactions outside the legitimate 
distribution chain illegal.” H.R. Rep. No. 1444, 91st 
Cong., 2d Sess. Pt. 1, at 3 (1970); see also Moore, 423 
U.S. at 141. The House Report further explains that 
Congress expected that the CSA would “significantly 
reduce the widespread diversion of these drugs out of 
legitimate channels into the illicit market, while at the 
same time providing the legitimate drug industry with 
a unified approach to narcotic and dangerous drug con- 
trol.” H.R. Rep. No. 1444, supra, Pt. 1, at 6; see also 
Moore, 423 U.S. at 135 (describing the CSA’s purpose to 
guard against the “diversion of drugs from legitimate 
channels to illegitimate channels”). 

To those ends, the CSA requires manufacturers, 
distributors, and dispensers of all controlled substances 
to register with the DEA. 21 U.S.C. 821, 822(a), 823; 21 
C.F.R. 1301. The Act also requires registrants to adopt 
effective controls to guard against the theft or diversion 
of controlled substances, 21 U.S.C. 823; 21 C.F.R. 
1301.71-1301.76, and authorizes the Attorney General to 
inspect a registrant’s establishment, 21 U.S.C. 822(f), 
880. The Act imposes other significant restrictions on 
the distribution of controlled substances to ensure a 
closed system of distribution. The Act requires the 
Attorney General to determine production quotas for 
schedules I and II controlled substances, 21 U.S.C. 826; 
21 C.F.R. 1303; imposes substantial recordkeeping and 
reporting requirements on registrants, 21 U.S.C. 827; 

22 

21 C.F.R. 1304; disallows the distribution of schedule I 
and II drugs except pursuant to an order form issued 
by the DEA, 21 U.S.C. 828(a); 21 C.F.R. 1305; and 
establishes prescription requirements for the dispens- 
ing of drugs in schedules II through V, 21 U.S.C. 829; 
21 C.F.R. 1306. 

10 

The Ninth Circuit’s decision completely abandons 
even any pretense of requiring respondents to comply 
with those provisions. Instead, it essentially permits 
respondents to function as an unregulated and un- 
supervised marijuana pharmacy—one that may distri- 
bute an unlimited amount of marijuana to an unlimited 
number of persons, as long as those persons assert, to 
the satisfaction of respondents (and later a judge or 
jury), that marijuana is the most effective drug for a 
serious medical condition. App. 7a-8a, 9a-10a. The 
recognition of a “medical necessity” defense not only 
flouts the CSA’s “ ‘closed’ system of drug distribution,” 
it also utterly defeats the CSA’s purposes to establish a 
comprehensive and unified approach to “dangerous 
drug control” and to guard against the risks of drug 
abuse and the diversion of controlled substances from 
“legitimate channels into the illicit market.” H.R. Rep. 
No. 1444, supra, Pt. 1, at 6. 

11 The fact that the Ninth 

10 The Attorney General also may deny, revoke, or suspend a 
registration under circumstances specified in the Act. 21 U.S.C. 
823, 824; 21 C.F.R. 1301.31-1301.37. 

11 Although the City of Oakland has passed a resolution that 
purports to establish a “Medical Cannabis Distribution Program” 
and designates OCBC as the City’s agent to administer the pro- 
gram (J.A. 145, 148), respondents do not assert that the City’s pro- 
gram comes close to complying with any of the strict controls 
imposed by the CSA to protect against marijuana abuse or diver- 
sion of the drug. Indeed, on several occasions, OCBC dispensed 
marijuana from its “Budbar” to undercover DEA agents who 

23 

Circuit’s decision has countenanced respondents’ 
distribution of marijuana, a schedule I drug, without 
any of the stringent controls placed on less restricted 
drugs listed in schedules II through V, simply 
highlights the absurdity of suggesting that a “medical 
necessity” defense can be reconciled with the CSA. 

c. The recognition of a “medical necessity” defense 
under the CSA similarly conflicts with Congress’s 
determination that the controls placed on schedule I 
controlled substances may not be altered unless and 
until the Attorney General and the Secretary of HHS 
follow the statutory procedures specified in the Act for 
the rescheduling of drugs. The CSA provides that any 
interested person may petition the DEA to initiate a 
rulemaking proceeding if he or she believes that medi- 
cal, scientific, or other relevant data warrant trans- 
ferring marijuana from schedule I to a less restrictive 

presented a membership card that OCBC had issued to another 
DEA agent based on a phony physician statement. See J.A. 47-50, 
53-61, 62-66. OCBC also apparently relies on patient-purchasers to 
determine what type of marijuana is medically appropriate. J.A. 
50 (“[T]he OCBC currently had seven kinds of marijuana for sale, 
all displayed. * * * I then purchased * * * marijuana with 
‘ brand name’ of ‘Northern Lights.’ ”); J.A. 60 (“ The sales counter 
* 

* * contained several small bottles marked ‘Small Hash Oil—$30,’ 
and ‘Large Hash Oil—$60.’ I also observed a small black square 
substance that was labeled ‘Afghani Hash, 20 grams—$400. * * * 
I asked for one-eighth ounce of the ‘House Special.’ ”); J.A. 65 
(When the OCBC clerk “asked me what I wanted to purchase. I 
pointed to a clear plastic baggie labeled ‘Mexican AA-Grade A.’ ”); 
J.A. 72 (“I * * * asked to purchase * * * marijuana with the 
‘ brand name’ of ‘ That’s Purdy.’ ”). 

Moreover, DEA agents visiting 

OCBC repeatedly detected the smell of burnt marijuana and ob- 
served marijuana either being smoked or grown on the premises. 
J.A. 49-50, 54, 57; see also J.A. 58 (An OCBC clerk “handed me 
several bags [of marijuana], and informed me that, ‘ it’s really good, 
I’ve just smoked some myself.’ ”). 

24 

schedule, so as to allow its use for medical purposes 
under the Act. 21 U.S.C. 811. 

12 Moreover, the CSA 
provides that any final administrative decision declin- 
ing to reschedule marijuana is subject to review by the 
courts of appeals, which must uphold the Attorney 
General’s factual findings if supported by substantial 
evidence. 21 U.S.C. 877. Based on that statutory 
framework, the courts of appeals uniformly have held 
that the statutory rescheduling process is the exclusive 
means by which criminal defendants charged with 
violating the Act may challenge marijuana’s placement 
in schedule I. See, e.g., United States v. Burton, 894 
F.2d 188, 192 (6th Cir.) (“it has repeatedly been deter- 
mined, and correctly so, that reclassification is clearly a 
task for the legislature and the attorney general and 
not a judicial one”), cert. denied, 498 U.S. 857 (1990). 

13 

Here, respondents do not claim that they have peti- 
tioned the Attorney General to reschedule or decontrol 
marijuana on the ground that the drug has a currently 
accepted medical use. Cf. Bailey, 444 U.S. at 410 (A 
necessity defense is unavailable “if there was a rea- 
sonable, legal alternative to violating the law.”). 

12 We have been informed by the DEA that in December 1997, 
the DEA referred to the Secretary of HHS a petition by John 
Gettman to reschedule marijuana because of an asserted lack of a 
high potential for abuse. HHS has informed us that its evaluation 
is in the final stages. After completion, the recommendation will 
be transmitted to the Administrator of the DEA. 

13 Accord United States v. Greene, 892 F.2d 453, 455 (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, 547 n.4 (8th Cir. 1982), cert. denied, 460 U.S. 1040 (1983); 
United States v. Middleton, 690 F.2d 820, 823 (11th 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). 

25 

Rather, respondents contend that Congress has con- 
sented to a common law scheme in which respondents 
in the first instance may decide whether smoking 
marijuana is medically appropriate. That contention 
simply flies in the face of Congress’s contrary judgment 
that it is the exclusive province of the Attorney General 
and the Secretary of HHS, under the statutory and 
administrative procedures set forth in the CSA, to 
determine, on a uniform and nationwide basis, whether 
the state of scientific and medical evidence warrants 
the use of marijuana for medical purposes—and if so, 
for which purposes and under what circumstances and 
restrictions. Congress most assuredly did not relegate 
that determination to respondents, or to individual 
courts and juries whenever a defendant asserts a 
“medical necessity” defense to a charged violation of 
the Act. 

14 

14 Respondents argue (Br. in Opp. 24) that this Court should be 
“particularly reluctant to assume” that Congress has foreclosed a 
“medical necessity” defense because individuals have a consti- 
tutional right to make “personal health decisions.” Even if we 
assume, arguendo, that respondents, who are distributors of mari- 
juana, could justify their own violation of the Act by invoking an 
asserted constitutional right of individuals to smoke marijuana in 
certain circumstances, there is, in actuality, no fundamental right 
to use an unapproved drug for medical treatment. See Carnohan 

v. United States, 616 F.2d 1120, 1122 (9th Cir. 1980) (per curiam) 
(Laetrile); Rutherford v. United States, 616 F.2d 455, 457 (10th 
Cir.) (Laetrile), cert. denied, 449 U.S. 937 (1980); United States v. 
Burzynski Cancer Research Inst., 819 F.2d 1301, 1313-1314 (5th 
Cir. 1987) (antineoplastons), cert. denied, 484 U.S. 1065 (1988); cf. 
Washington v. Glucksberg, 521 U.S. 702, 723, 728 (1997) (no funda- 
mental due process right to assisted suicide). Similarly, the courts 
of appeals have uniformly rejected constitutional challenges to 
Congress’s classification of marijuana as a schedule I drug. See 
Greene, 892 F.2d at 455-456; United States v. Fry, 787 F.2d 903, 
905 (4th Cir.), cert. denied, 479 U.S. 861 (1986); Fogarty, 692 F.2d 

26 

d. Finally, the recognition of a “medical necessity” 
defense is inconsistent with the fact that marijuana has 
not been approved by the FDA based upon a showing 
that marijuana is safe and effective for any medical use. 
See 21 U.S.C. 321(p), 355. In the 1998 legislation, Con- 
gress expressed its continuing adherence to the exist- 
ing FDA drug approval process by stating that 
“marijuana * * * has not been proven safe and 
effective for medical purposes” and that marijuana has 
“not been approved by the [FDA] to treat any disease 
or condition.” 112 Stat. 2681-760 to 2681-761. 

15 

The provision’s sponsor, Representative McCollom, 
explained that the 1998 “statement is important” be- 
cause, inter alia, “[m]ore 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 
id. at S10,666 (daily ed. Sept. 21, 1998). Congress 
therefore expressed not only its continuing support for 
the “existing Federal legal process for determining the 
safety and efficacy of drugs,” but also its opposition to 
“efforts to circumvent this process by legalizing 

at 547-548 & n.4; Middleton, 690 F.2d at 822-823; Kiffer, 477 F.2d 
at 352-357. 

15 Respondents argue (Br. in Opp. 20) that the 1998 legislation 
“does not have the force of law.” Respondents ignore the fact that 
Congress already has barred the unauthorized distribution of 
marijuana for all purposes. The 1998 Act expressly confirms that 
preexisting prohibition specifically with respect to the use of mari- 
juana for asserted medical purposes. See generally Accardi v. 
Pennsylvania R.R., 383 U.S. 225, 229 (1966) (continuing purpose of 
Congress reflected in “sense of the Congress” enactment); Harris 

v. United States, 359 U.S. 19, 22 n.8 (1959) (continuing purpose of 
Congress reflected in subsequently-enacted legislation). 

27 

marijuana * * * for medicinal use without valid 
scientific evidence and the approval of the Food and 
Drug Administration.” 112 Stat. 2681-761 (emphasis 
added). The 1998 Act thus refutes the notion that 
courts and juries may allow the federally-unregulated 
distribution of marijuana based on a common law prin- 
ciple that Congress would have sanctioned such distri- 
bution had it considered the competing values at stake. 

3. In United States v. Rutherford, 442 U.S. 544 
(1979), this Court considered a highly analogous issue 
and held that a claim of medical need for a drug cannot 
override Congress’s legislative judgment that the drug 
not be distributed absent a finding by the FDA under 
the FDCA that the drug is 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. The district court granted the requested relief, 
and the Tenth Circuit affirmed, holding that the safety 
and effectiveness protections of the FDCA had no rea- 
sonable application to terminally ill cancer patients be- 
cause those patients, by definition, would die of cancer 
regardless of their treatment. Id. at 548-549. 

This Court unanimously reversed. The Court 
rejected the Tenth Circuit’s determination that an ex- 
emption from the Act was justified because the safety 
and effectiveness standards could have no reasonable 
application to terminally ill cancer patients, explaining 
that, “[u]nder our constitutional 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.” 442 

28 

U.S. at 555, 559. The Court also reasoned that the 
FDCA “makes no special provision for drugs used to 
treat terminally ill patients,” and that “[w]hen con- 
struing a statute so explicit in scope,” it is incumbent 
upon the courts to give it effect. Id. at 551. 

Finally, the Court reasoned that the recognition of a 
non-statutory exception to the federal drug laws could 
wreak havoc on Congress’s aim to avert the dangers 
associated with the unregulated use and distribution of 
unapproved drugs: 

It bears emphasis that although the Court of Ap- 
peals’ ruling was limited to Laetrile, its reasoning 
cannot be so readily confined. To accept the pro- 
position 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. 

The Court’s holding and reasoning in Rutherford 
apply with equal force in this case, where Congress has 
expressed its unambiguous intent in the CSA to ban the 
unauthorized distribution of marijuana, even for medi- 
cal purposes. By sanctioning the ongoing and open 
violation of the federal drug laws, the court of appeals’ 
decision opens the way for manufacturers, distributors, 
or users of other schedule I drugs (such as heroin or 
LSD)—which have not been approved by the FDA for 
any medical use and which are controlled under the 
CSA because of their “high potential for abuse” and 
“lack of accepted safety for use” even “under medical 
supervision”—to invoke “medical necessity” as a de- 
fense to a violation of the nation’s drugs law. The re- 

29 

cognition of a “medical necessity” defense under the 
CSA therefore would significantly undermine the Act’s 
paramount policy to protect the public health and 
safety. See 21 U.S.C. 801(2). 

4. Respondents contend (Br. in Opp. 6, 21-22, 25-29) 
that Congress’s determination that marijuana has no 
accepted medical use is harmonious with their unregu- 
lated distribution of marijuana because the statutory 
phrase “currently accepted medical use in treatment” 
(21 U.S.C. 812(b)(1)(B)) serves a different purpose than 
that served by the common law defense of “medical 
necessity.” Respondents reason (Br. in Opp. 26, 28) 
that Congress placed marijuana in schedule I to restrict 
its distribution to the “general public,” while a “medical 
necessity” defense permits the distribution of mari- 
juana only when patients and their physicians “jointly 
agree” that “generally accepted treatments are ineffec- 
tive.” Those contentions are legally irrelevant and, in 
any event, are fundamentally mistaken. 

a. It is precisely because Congress has determined 
that marijuana has no “currently accepted medical use” 
and placed that drug in schedule I that Congress has 
emphatically foreclosed a distributor from ignoring the 
CSA on the ground that the recipients claim a medical 
need to smoke marijuana. Thus, the CSA imposes an 
absolute ban on the distribution of marijuana— 
including distribution for asserted medical purposes— 
outside the strict confines of the Act itself. See pp. 19- 
20, supra. And even for drugs listed in schedules II 
through V, which Congress or the Attorney General 
has determined do have an accepted and safe medical 
use, 21 U.S.C. 812(b)(2)-(5), and for which the CSA does 
permit physicians to determine whether particular pa- 
tients have a medical need for the drug, 21 U.S.C. 829, 
the CSA imposes strict controls on physicians and phar- 

30 

macies before they may distribute or dispense the drug. 
See pp. 20-23, supra. That comprehensive set of statu- 
tory controls leaves no room for the distribution of 
marijuana for asserted medical purposes by relying on a 
common law defense of necessity. 

b. In any event, the notion that respondents may 
dispense marijuana for medical use is inconsistent 
with the CSA’s determination that marijuana has no 
“currently accepted medical use” (21 U.S.C. 
812(b)(1)(B)), as well as the absence of a finding by the 
FDA under the FDCA that marijuana is “safe and 
effective” for any intended medical use (21 U.S.C. 355). 
See also 112 Stat. 2681-760 (finding that marijuana is 
“unsafe, even under medical supervision”; “lack[s] any 
currently accepted medical use”; and has never been 
approved by the FDA as “safe and effective” “to treat 
any disease or condition”). Respondents cannot credi- 
bly maintain that Congress intended to permit de- 
fendants charged with violating the CSA to persuade 
courts and juries that smoking marijuana “has proven 
effective in relieving [patients’ medical] conditions or 
symptoms” (Br. in Opp. 22) when Congress already has 
most emphatically determined that marijuana, in fact, 
has not been “proven” to be safe or effective to treat 
any medical condition. 

16 

16 Nor is it plausible to suggest (Br. in Opp. 26-29) that re- 
cognition of a “medical necessity” defense would be confined to a 
limited number of individuals or class of medical conditions. For 
instance, on May 19 and October 22, 1997, two undercover DEA 
agents purchased marijuana from respondents by presenting 
phony physician statements asserting that the agents suffered 
from post-traumatic stress disorder and menstrual cramps. J.A. 
48, 70. Moreover, on May 21, 1998, approximately 200 persons 
visited OCBC to obtain marijuana to treat a wide variety of 
conditions, including AIDS, cancer, glaucoma, pain, headaches, 

31 

c. Similarly, to allow courts and juries to consider 
whether marijuana is medically “efficacious” or con- 
sistent with “good medical practice” for a given individ- 
ual (Br. in Opp. 28, 29) would subvert Congress’s intent 
to bar the medical use of a schedule I drug until 
rigorous scientific proof establishes that the drug no 
longer meets the statutory criteria for listing under 
that schedule. Before marijuana may be removed from 
schedule I, the Attorney General, in consultation with 
the Secretary of HHS, must determine that marijuana 
has a “currently accepted medical use in treatment in 
the United States.” 21 U.S.C. 812(b)(2)(B), (3)(B), 
(4)(B) and (5)(B). In making that determination, the 
Attorney General and the Secretary must consider the 
“[s]cientific evidence of [drug’s] pharmacological effect” 
and “state of current scientific knowledge regarding the 
drug.” 21 U.S.C. 811 (c)(2) and (3). 

Applying those provisions, in 1992, the DEA Admini- 
strator concluded in response to a petition to reschedule 
marijuana that marijuana has no currently accepted 
medical use and therefore should not be transferred to 
schedule II. 57 Fed. Reg. 10,499. The Administrator 
also delineated the five characteristics that a drug must 
have in order to find that it has a currently accepted 

arthritis, rotator cuff syndrome, stress, depression, paranoid 
schizophrenia, and anxiety. See J.A. 32-39. Similarly, in request- 
ing the district court to modify its injunction in light of the Ninth 
Circuit’s decision, respondents submitted the affidavits of persons 
who asserted that they used marijuana for medical conditions such 
as lupus, irritable bowel syndrome, cystitis, cancer, arthritis, 
insomnia, Hepatitis C, AIDS, scoliosis, esophageal stricture, 
Meniere’s disease, sarcoidosis, leg and back spasms, migraine 
headaches, depression, and bulimia. Vol. 1 Declarations in Support 
of Defendants’ Motion to Dissolve or Modify Preliminary Injunc- 
tion Order (filed May 30, 2000). 

32 

medical use: (1) the drug’s chemistry must be known 
and reproducible; (2) there must be adequate studies 
proving the drug’s safety in treating a specific, recog- 
nized disorder; (3) there must be adequate and well- 
controlled studies proving the drug’s efficacy in treat- 
ing a specific, recognized disorder; (4) the drug must be 
accepted by qualified experts; and (5) the scientific 
evidence must be widely available. Id. at 10,506. Based 
on a consideration of those five factors, as well as 
the lack of reliable scientific evidence supporting the 
medical use of marijuana for any medical condition, id. 
at 10,500-10,505, the Administrator concluded that 
“[m]arijuana fails all five points of the test.” Id. at 
10,507. 

The Administrator also addressed the testimony of 
individuals and physicians who opined that marijuana 
had a medical use, explaining that “[l]ay testimonials, 
impressions of physicians, isolated case studies, random 
clinical experience, reports so lacking in details they 
cannot be scientifically evaluated, and all other forms of 
anecdotal proof ” do not provide a sufficiently reliable 
basis under the CSA for assessing the safety and effi- 
cacy of marijuana or any other drug. 57 Fed. Reg. at 
10,505. The Administrator’s determinations were up- 
held by the District of Columbia Circuit, which con- 
cluded that the Administrator reasonably insisted on 
“rigorous scientific proof over anecdotal evidence, even 
when reported by respected physicians.” Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1137 
(1994). The court of appeals also reasoned that the 
Administrator had properly relied on “the testimony of 
numerous experts that marijuana’s medicinal value has 
never been proven in sound scientific studies,” and that 
“[t]he Administrator reasonably accorded more weight 
to the opinions of these experts than to the anecdotal 

33 

testimony of laymen and doctors.” Ibid. The court of 
appeals therefore concluded that the Administrator’s 
“findings are consistent with the view that only 
rigorous scientific proof can satisfy the CSA’s 
‘currently accepted medical use’ requirement.” Ibid. 

Congress in the FDCA similarly has rejected reliance 
on the subjective views of individual physicians and 
patients to support the use of a new drug, such as mari- 
juana, for medical use. The FDCA requires that, before 
the FDA may approve a new drug, the drug must be 
proven safe through “adequate tests by all methods 
reasonably applicable” and proven effective based on 
“adequate and well-controlled investigations, including 
clinical investigations, by experts qualified by scientific 
training and experience to evaluate the effectiveness of 
the drug involved.” 21 U.S.C. 355(d); accord 112 Stat. 
2681-760 (new drug “must meet extensive scientific and 
medical standards established by the [FDA] to ensure 
it is safe and effective”). The FDA therefore will not 
consider “[i]solated case reports, random experience, 
and reports lacking the details which permit scientific 
evaluation.” 21 C.F.R. 314.126(e); see Rutherford, 442 
U.S. at 550 n.7 (The FDCA requires “an ‘expert con- 
sensus’ on safety and effectiveness founded upon ‘sub- 
stantial evidence’ as defined in [21 U.S.C. 355(d)].”); 
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 
U.S. 609, 619 (1973) (The FDA’s “strict and demanding 
standards,” which “bar[] anecdotal evidence indicating 
that doctors ‘believe’ in the efficacy of a drug, are amply 
justified by the legislative history” of the FDCA, which 
reflects “a marked concern that impressions or beliefs 
of physicians, no matter how fervently held, are treach- 
erous.”). 

At bottom, the recognition of a “medical necessity” 
defense would bypass altogether the statutory pro- 

34 

cedures that Congress enacted for the rescheduling of a 
drug by the Attorney General and for the approval of a 
drug by the FDA, in favor of a judicially sanctioned 
system in which individual patients, physicians, and 
cannabis clubs decide whether marijuana is safe and 
effective for medical use. Congress plainly did not 
intend to permit a result that would render so “wholly 
nugatory” (Bailey, 444 U.S. at 416 n.11) the statutory 
framework of the CSA. 

5. Respondents assert (Br. in Opp. 18) that the 
CSA’s history shows that “Congress placed cannabis 
only tentatively in Schedule I” because Congress “did 
not have a firm understanding of cannabis.” Respon- 
dents observe (id. at 18-20) that the House Report 
stated that “[t]he extent to which marihuana should be 
controlled is a subject upon which opinions diverge 
widely” (H.R. Rep. No. 1444, supra, Pt. 1, at 12); that 
the Secretary of Health, Education, and Welfare re- 
commended to Congress that marijuana “be retained 
within schedule I” until the completion of further 
studies (id. at 13); and that a Commission established 
by Congress recommended the decriminalization of 
casual distribution of small amounts of marijuana for no 
remuneration or insignificant remuneration not involv- 
ing profit (National Comm’n on Marihuana & Drug 
Abuse, Marihuana: A Signal of Misunderstanding 152 
(Mar. 1972) (Marihuana)). 

17 Nothing in that history, 

17 The Commission explained that many users of marijuana had 
been given the drug by a “friend, acquaintance or family member,” 
and that such “casual transfers” should be treated “as the func- 
tional equivalent of possession.” Marihuana 157, 158. The Com- 
mission also recommended that there should be no federal criminal 
sanction for possession of marijuana for personal use, reasoning 
that federal agencies “have left possession enforcement to the 
states * * * to maximize the use of [federal] enforcement re- 

35 

however, casts doubt on the fact that Congress placed 
marijuana in schedule I, where it has been listed for 30 
years, knowing full well that it was categorically 
banning the distribution of marijuana for any purpose, 
including asserted medical uses, except as authorized 
by the CSA. See H.R. Rep. No. 1444, supra, Pt. 1, at 13 
(“marihuana is listed under schedule I, as subject to the 
most stringent controls under the bill”); see also 116 
Cong. Rec. 1664 (1970) (statement of Sen. Hruska) 
(noting that marijuana was placed in schedule I because 
it “comes squarely within the criteria of that schedule,” 

i.e., “highest abuse potential” and “little or no accepted 
medical use in this country”). 

We do not dispute that Congress contemplated the 
possibility that further research could produce scientific 
evidence that would support the use for medical pur- 
poses of certain substances, including marijuana, that 
Congress initially listed in schedule I. But Congress 
directed that, to be credited and given weight under 
the CSA, any such research must be presented, not to 
organizations like OCBC, or to courts and juries in 
individual proceedings brought by the United States to 
enforce the CSA, but to the Attorney General and the 
Secretary of HHS to consider under the exclusive stan- 
dards and administrative procedures set forth in the 
CSA itself. 21 U.S.C. 811, 812; see pp. 23-25, supra. 

18 

sources for major priorities,” such as eliminating marijuana traf- 
fickers and suppliers. Id. at 155-156. Notwithstanding the Com- 
mission’s recommendations, Congress in the CSA has maintained 
criminal penalties for both the possession of marijuana and the 
casual distribution of marijuana that does not involve profit. See 
21 U.S.C. 841(a)(1), 844(a). 

18 There is no petition pending before the DEA to reschedule 
marijuana on the ground that marijuana has any accepted medical 
use. Cf. note 12, supra. We do note, however, that studies are 

36 

The history of the CSA therefore provides no basis 
whatsoever for inferring a congressional intent to 
permit the distribution of marijuana outside the 
framework of the CSA, based on an asserted medical 
need to smoke it. 

underway that involve the human health effects of marijuana. We 
are informed by the DEA that two researchers are currently 
registered with the DEA to conduct clinical research under 21 
U.S.C. 823(f) into the human health effects of smoked marijuana. 
Moreover, on May 21, 1999, HHS announced new guidance for the 
provision of marijuana for medical research. See Kuromiya v. 
United States, 78 F. Supp. 2d 367, 374 (E.D. Pa. 1999). We also 
note that, in 1999, the Institute of Medicine reviewed the existing 
scientific evidence concerning possible medical uses of marijuana 
and recommended that further research be devoted, not to de- 
veloping marijuana as a licensed drug, but to developing a method 
of delivering cannabinoids without the serious adverse health 
consequences associated with smoking marijuana. See Institute of 
Medicine, Marijuana and Medicine: Assessing the Science Base 
10-11 (Janet E. Joy et al. eds. 1999) (noting that “[b]ecause mari- 
juana is a crude THC delivery system that also delivers harmful 
substances, smoked marijuana should generally not be recom- 
mended for medical use,” and recommending “clinical trials * * * 
to serve as a first step toward the development of nonsmoked 
rapid-onset cannabinoid delivery systems”). One method of 
delivery of cannabinoids currently available is Marinol®, which 
contains a synthetic form of THC in pill form. Marinol® has been 
approved by the FDA for the treatment of nausea and vomiting 
associated with cancer chemotherapy and for the treatment of 
anorexia associated with weight loss in AIDS patients. See 64 
Fed. Reg. 35,928 (1999). On July 2, 1999, DEA transferred 
Marinol® from schedule II to schedule III, thereby lessening the 
regulatory restrictions on its use. Ibid. 

37 

B. Courts Lack The Equitable Discretion Under The CSA 

To Permit The Unauthorized Distribution Of Mari- 
juana To Persons Who Assert A Medical Necessity To 

Use It 

1. In holding that “medical necessity” is a “legally 
cognizable defense” (App. 8a), the court of appeals 
did not attempt to reconcile a “medical necessity” de- 
fense either with the text, structure, or purposes of the 
CSA, or with the 1998 legislation disapproving any 
attempt to legalize marijuana for medicinal use outside 
the existing framework 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” under 21 U.S.C. 
882(a). App. 9a (quoting Northern Cheyenne Tribe v. 
Hodel, 851 F.2d 1152, 1156 (9th Cir. 1988)). The court of 
appeals took the view that the district court abused its 
discretion first in failing to consider what the court of 
appeals identified as “a 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 govern- 
ment’s “general interest in enforcing its statutes.” Id. 
at 9a, 11a. 

Those conclusions, however, conflict 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 legislation.” Virginian Ry. 

v. System Fed’n No. 40, 300 U.S. 515, 551 (1937); see 
also Albemarle Paper Co. v. Moody, 422 U.S. 405, 417 

38 

(1975) (“when Congress invokes the Chancellor’s con- 
science to further transcendent legislative purposes, 
what is required is the principled application of stan- 
dards consistent with those purposes and not ‘equity 
[which] varies like the Chancellor’s foot’ ”). 

Those principles were reaffirmed in TVA v. Hill, 437 
U.S. 153 (1978), in which this Court held that, in 
examining whether to enter injunctive relief, a court 
must be mindful that 

it is * * * emphatically * * * the exclusive pro- 
vince of the Congress not only to formulate legis- 
lative policies and mandate programs and projects, 
but also to establish their relative priority for the 
Nation. Once Congress, exercising its delegated 
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 enforce- 
ment is sought. 

Id. at 194. 

19 The Court similarly has explained that 
although it will “not lightly assume that Congress 
meant to restrict the equitable powers of the federal 
courts,” “where Congress has made its intent clear, 
‘[the Court] must give effect to that intent.’ ” 

Miller v. 
French, 120 S. Ct. 2246, 2253 (2000) (quoting Sinclair 
Refining Co. v. Atkinson, 370 U.S. 195, 215 (1962)); see 
also Weinberger v. Romero-Barcelo, 456 U.S. 305, 313 
(1982) (“[A] statute in so many words, or by a necessary 
and inescapable inference, [may] restrict[] the court’s 

19 One commentator has explained that Hill “established that a 
court cannot use equitable discretion as a pretext for reordering 
priorities that Congress already has set.” Daniel A. Farber, Equit- 
able Discretion, Legal Duties, and Environmental Injunctions, 45 
U. Pitt. L. Rev. 513, 519 (1984). 

39 

jurisdiction in equity.”) (quoting Porter v. Warner 
Holding Co., 328 U.S. 395, 398 (1946)). 

In similar circumstances, this Court in Rutherford 
(discussed at pp. 27-28, supra) held that the Tenth 
Circuit erred in holding that a district court had the 
power to enter an injunction permitting the use of an 
unapproved drug (Laetrile) by terminally ill cancer 
patients, even under a doctor’s supervision, because the 
FDCA “makes no special provision for drugs used to 
treat terminally ill patients.” 442 U.S. at 551. 

20 The 
CSA similarly “makes no special provision” for the un- 
authorized distribution of drugs for medical use, no 
matter how fervently individual patients or doctors 
believe that a drug has a medical use. Congress already 
has considered the public interest, balanced the rele- 
vant medical and other policy considerations, and made 
the fundamental policy choice that “[t]he illegal * * * 
distribution[] and * * * improper use of controlled 
substances have a substantial and detrimental effect on 
the health and general welfare of the American people.” 
21 U.S.C. 801(2). Congress therefore has concluded 
that, unless and until the Attorney General removes 
marijuana from schedule I, the drug has no accepted 
medical or safe use and may not be distributed outside 
of a strictly controlled research project under the CSA. 
See pp. 19-20, supra. A district court therefore lacks 
the discretion, based on its own perception of the public 
interest and its own weighing of possible medical bene- 

20 Indeed, the Court in Rutherford cited Hill with approval, 
observing that “[e]xceptions to clearly delineated statutes will be 
implied only where essential to prevent absurd results or conse- 
quences obviously at variance with the policy of the enactment as a 
whole.” 442 U.S. at 552 (internal quotation marks omitted); accord 
id. at 555. 

40 

fits against the potential for abuse, to craft an injunc- 
tion under the CSA that exempts from the injunction’s 
reach the distribution of marijuana for medical use. 

2. In defending the judgment of the court of appeals, 
respondents argue (Br. in Opp. 13-17) that a court may 
decline to enjoin a cannabis distribution club from 
distributing marijuana in blatant violation of the CSA, 
whether or not “medical necessity” is a valid defense 
under the Act. Not even the court of appeals, however, 
embraced that radical proposition. See App. 8a (finding 
that the district court failed to “take into account a 
legally cognizable defense that likely would pertain in 
the circumstances”). 

21 

Nor is such a proposition supported by any decision 
of this Court. As previously explained, district courts 
sitting in equity cannot “ignore the judgment of Con- 
gress” that is “deliberately expressed in legislation.” 
Virginian Ry., 300 U.S. at 551; see also Miller, 120 
S. Ct. at 2253; Hill, 437 U.S. at 194. Respondents 
therefore erroneously rely on this Court’s decisions in 
Romero-Barcelo, supra, and Hecht Co. v. Bowles, 321 
U.S. 321 (1944). Those decisions confirm that a court 
may not exercise its equitable discretion—which is 
intended to allow a court to decide how best to assure 
compliance with a congressional act—so as to counte- 
nance ongoing violation of a congressional act. 

In Romero-Barcelo, the Court held that under the 
Federal Water Pollution Control Act, the district court 
retained discretion in appropriate circumstances to 

21 The district court’s modification of its injunction likewise 
was premised only on the assumption that, because “medical neces- 
sity” is a valid defense under the CSA, a district court has the 
equitable power to permit the medical use of marijuana in violation 
of the CSA. App. 13a. 

41 

order relief other than an immediate injunction barring 
all discharge of pollutants that did not comply with the 
Act if that other relief would “achieve compliance” with 
the Act. 456 U.S. at 307. The district court found that 
the Navy had committed “technical violations” of the 
statute, without “causing any ‘appreciable harm’ to the 
environment,” by occasionally discharging ordnance 
into the sea without a permit. Id. at 310. The district 
court ordered the Navy to apply for the requisite per- 
mit, but declined to enjoin naval operations, concluding 
that an injunction was not necessary to ensure com- 
pliance. Ibid. This Court found that “although the 
District Court declined to enjoin the discharges, it 
neither ignored the statutory violation nor undercut the 
purpose and function of the permit system.” Id. at 315. 
The Court further observed that, “[r]ather than re- 
quiring a district court to issue an injunction for any 
and all statutory violations, the FWPCA permits the 
district court to order that relief it considers necessary 
to secure prompt compliance with the Act.” Id. at 320 
(emphasis added). 

Similarly, in Hecht Co., the district court declined the 
government’s request for an injunction against a de- 
fendant that had violated statutory price controls. The 
district court reasoned that it had “no doubt” that the 
defendant acted in “good faith and diligence” in at- 
tempting to comply with the statute, that the defendant 
had taken “vigorous steps” to correct and prevent re- 
currence of its mistakes, and that issuance of an 
injunction would have “no effect” on ensuring future 
compliance with the statute. 321 U.S. at 325, 326. This 
Court concluded that under the statute “there is some 
room for the exercise of discretion on the part of the 
court,” and further observed that other remedial orders 
short of injunction might have been consistent with the 

42 

statute. Id. at 328. The Court made clear, however, 
that courts have the responsibility to enforce the 
statute and that “their discretion under [the statute] 
must be exercised in light of the large objectives of the 
Act,” “[f]or the standards of the public interest, not the 
requirements of private litigation, measure the propri- 
ety and need for injunctive relief.” Id. at 331. 

22 

Those decisions therefore provide no support for a 
district court, under its authority “to enjoin violations” 
of the CSA, 21 U.S.C. 882(a) (emphasis added), to allow 
the ongoing illegal distribution of marijuana, based on 
the court’s perception that the public interest supports 
the use of marijuana for medical purposes. As we have 
explained, Congress already has weighed what it 
deemed to be the relevant public-interest considera- 
tions and categorically determined that marijuana may 

22 Contrary to respondents’ suggestion (Br. in Opp. 17), Amoco 
Production Co. v. Village of Gambell, 480 U.S. 531 (1987), likewise 
does not support the invocation of a district court’s equitable 
power to permit respondents to distribute marijuana in violation of 
the CSA. The Court in Amoco held that a district court did not err 
in declining to issue an injunction to bar exploratory drilling on 
Alaskan public lands, because the district court’s decision “did not 
undermine” the policy of the Alaska National Interest Lands Con- 
servation Act, 16 U.S.C. 3120, “to protect Alaskan subsistence re- 
sources from unnecessary destruction.” 480 U.S. at 544, 546. The 
Court reasoned that the exploration activities would not signifi- 
cantly restrict the subsistence uses of the land; that the denial of 
injunctive relief did not deprive the government of its ability to 
control and shape the leasing process; and that Congress had 
expressed a policy favoring continued oil exploration in another 
federal statute. Id. at 544-545. Nothing in the Court’s decision in 
Amoco suggests that a court may use its equity power to deter- 
mine that the public interest supports conduct that is funda- 
mentally antithetical to the text, structure, and policy of the 
statute that the court is supposed to enforce. 

43 

not be distributed for any purpose, “[e]xcept as author- 
ized” by the Act, 21 U.S.C. 841(a)(1). Congress there- 
fore has “deliberately expressed” (Virginian Ry., 300 
U.S. at 551) its intention to foreclose a district court 
from using the power conferred under 21 U.S.C. 882(a) 
to permit the ongoing and illegal distribution of mari- 
juana for asserted medical purposes. 

CONCLUSION 

The judgment of the court of appeals should be 
reversed. 

Respectfully submitted. 

SETH P. WAXMAN 

Solicitor General 

DAVID W. OGDEN 

Assistant Attorney General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

LISA SCHIAVO BLATT 

Assistant to the Solicitor 

General 

JANUARY 2001