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

PETITION FOR A WRIT OF CERTIORARI 

SETH P. WAXMAN 

Solicitor General 

Counsel of Record 

DAVID W. OGDEN 

Acting Assistant Attorney 

General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

LISA SCHIAVO BLATT 

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 distri- 
buting marijuana, a Schedule I controlled substance. 

(I) 

TABLE OF CONTENTS 

Page 

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

Jurisdiction ...................................................................................... 2 

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

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

Reasons for granting the petition ............................................... 
7 

Conclusion ....................................................................................... 24 

TABLE OF AUTHORITIES 

Cases: 

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

(1966) .......................................................................................... 12 

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

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

10 

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

12 

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

17 

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

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

16 

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

1992) ........................................................................................... 16 

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

18 

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

App. 1999) ................................................................................. 

16 

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

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

4 

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

16 

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

16 

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

1992) ........................................................................................... 16 

State v. Hanson, 468 N.W.2d 77 (Minn. Ct. App. 

1991) ........................................................................................... 16 

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

16 

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

16 

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

May 8, 2000) .............................................................................. 16 

(III) 

IV 

Cases—Continued: Page 

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

16 

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

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

16 

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

17 

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

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

16 

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

13 

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

30375 (4th Cir. Feb. 10, 1993) ................................................ 

15 

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

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

10, 15 

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

(E.D. Wash. Sept. 21, 1998) .................................................... 

16 

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

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

10 

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

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

10 

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

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

11 

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

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

16 

United Sates v. McWilliams, No. CR 97-997(A)- 
GHK (C.D. Cal. Nov. 5, 1999) ................................................ 

15 

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

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

10-11 

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

9, 13 

United States v. Oakland Cannabis Buyers’ Coop., 

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

5 

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

14, 15, 21 

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

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

8 

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

Feb. 3, 2000) .............................................................................. 

20 

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

1984) ........................................................................................... 10 

V 

Cases—Continued: Page 

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

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

17 

Constitution, statutes and regulations: 

U.S. Const. Amend. V ................................................................ 

5 

Controlled Substances Act, 21 U.S.C. 801 et seq. ................. 

2 

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

9 

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

13, 19 

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

10 

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

10 

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

19 

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

7, 9, 13, 18 

21 U.S.C. 822-829 ..................................................................... 

10 

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

13 

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

13 

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

13 

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

9, 13, 18, 19 

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

14 

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

14 

21 U.S.C. 828 ............................................................................. 

14 

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

9, 14 

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

3 

21 U.S.C. 841(a) ........................................................................ 

18 

21 U.S.C. 841(a)(1) ............................................................. 

6, 9, 13 

21 U.S.C. 877 ............................................................................. 

10 

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

13-14 

21 U.S.C. 882(a) ........................................................................ 

3 

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

2681-761 ............................................................................... 

2, 7, 12 

21 C.F.R.: 

Pt. 5: 

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

VI 

Statutes and regulations—Continued: 
Page 

Pt. 1301: 

Section 1301 .......................................................................... 

13 

Section 1301.18 .................................................................... 

9 

Section 1301.32 .................................................................... 

9 

Section 1301.71-1301.76 ...................................................... 

13 

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

14 

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

14 

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

14 

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

14 

Section 1308.43 .................................................................... 

10 

28 C.F.R. 0.100(b) ........................................................................ 

9 

Alaska Stat. (Michie 1999): 

§ 11.71.090 ................................................................................. 

20 

§ 17.37.010-17.37.080 ................................................................ 

20 

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

2 

Cal. Health & Safety Code (West 1999): 

§ 11362.5(b)(1)(A) ..................................................................... 

2, 20 

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

2, 20 

Or. Rev. Stat. §§ 475.300-475.346 (1999) ................................. 

20 

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

20 

Miscellaneous: 

144 Cong. Rec.: 

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

12 

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

12 

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

20 

Carey Goldberg, Maine Mulls Medical Use for its Seized 

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

20 

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

July 12, 2000) ............................................................................ 

20 

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

Criminal Law (1986) ............................................................... 

8 

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

the United States (1994) .......................................................... 19 

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

PETITION FOR A WRIT OF CERTIORARI 

The Solicitor General, on behalf of the United States 
of America, respectfully petitions for a writ of certiorari 
to review the judgment of the United States Court of 
Appeals for the Ninth Circuit in this case. 

OPINIONS BELOW 

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

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

(1) 

2 

JURISDICTION 

The judgment of the court of appeals was entered on 
September 13, 1999. A petition for rehearing was 
denied on February 29, 2000 (App. 82a). On May 22, 
2000, Justice O’Connor extended the time within which 
to file a petition for a writ of certiorari to and including 
June 28, 2000, and on June 19, 2000, Justice O’Connor 
further extended the time within which to file a petition 
to and including July 28, 2000. The jurisdiction of this 
Court is invoked under 28 U.S.C. 1254(1). 

STATUTORY PROVISIONS INVOLVED 

The relevant provisions of the Controlled Substances 
Act (CSA), 21 U.S.C. 801 et seq., and Pub. L. No. 105- 
277, Div. F, 112 Stat. 2681-760 to 2681-761, are set forth 
at App. 83a-92a. 

STATEMENT 

1. On January 9, 1998, the United States filed suit 
seeking an injunction against six marijuana distributors 
and ten associated individuals, alleging that the defen- 
dants’ ongoing distribution (and in some cases manufac- 
ture) of marijuana violated the Controlled Substances 
Act (CSA).2 

On May 19, 1998, the District Court for 
the Northern District of California issued a preliminary 
injunction prohibiting the Oakland Cannabis Buyers’ 
Cooperative and its director (collectively OCBC) and 
other marijuana distributors from manufacturing and 
distributing marijuana. App. 39a-40a (order); 41a-81a 

2 Many such groups formed in the wake of California’s 
Compassionate Use Act, or Proposition 215, passed in November 
1996, which purports to authorize the possession and use of mari- 
juana for medical purposes upon a physician’s recommendation. 
See Cal. Health & Safety Code § 11362.5(b)(1)(A) and (d) (West 
1999). 

3 

(memorandum opinion).3 On May 21, 1998, OCBC vio- 
lated the injunction by openly distributing marijuana to 
numerous persons. Id. at 21a-23a. On October 13, 
1998, the district court issued an order finding OCBC in 
civil contempt. Id. at 20a-37a. On October 16, 1998, the 
district court issued an order denying OCBC’s motion 
to modify the injunction to permit marijuana distribu- 
tion to persons who, in OCBC’s view, have a “medical 
necessity,” i.e., persons having a doctor’s certificate 
stating that (1) the person suffers from a serious 
medical condition; (2) the person would suffer imminent 
harm if he does not have access to marijuana; (3) 
marijuana is necessary for treatment of the person’s 
condition or would alleviate the condition or symptoms 
associated with it; and (4) there is no legal alternative 
for the effective treatment of the condition because 
alternative legal drugs are either ineffective or result in 
intolerable side effects. Id. at 19a (denying motion for 
modification); see also id. at 7a-8a, 28a-29a (describing 
proposed medical necessity defense). 

2. In a per curiam opinion, the court of appeals 
reversed the district court’s denial of the motion to 
modify the injunction to allow the use of marijuana 
based on asserted medical necessity. App. 1a-11a.4 The 

3 In addition to the imposition of criminal and civil penalties for 
violations of the CSA, see 21 U.S.C. 841-863 (1994 & Supp. IV 
1998), the CSA gives district courts jurisdiction to enjoin violations 
of the Act, 21 U.S.C. 882(a). 

4 The court of appeals also held that it lacked jurisdiction over 
OCBC’s appeal of the district court’s denial of a motion to dismiss, 
App. 2a-5a, and that OCBC’s appeal of the district court’s order 
finding it in contempt was moot because the district court on 
October 30, 1998, vacated its contempt order after OCBC repre- 
sented to the court that it would comply with the injunction, id. at 
5a-7a. Those rulings are not at issue here. 

4 

court of appeals held that the district court, in 
construing its equitable power to issue an injunction, 
erred in not “tak[ing] into account a legally cognizable 
defense that likely would pertain in the circumstances.” 
Id. at 8a. The court of appeals explained that it saw “no 
indication that the ‘underlying substantive policy’ of the 
[CSA] mandates a limitation on the district court’s 
equitable powers” “to formulate appropriate relief 
when and if injunctions are sought.” Id. at 9a (quoting 
Northern Cheyenne Tribe v. Hodel, 851 F.2d 1152, 1156 
(9th Cir. 1988)). 

The court of appeals further concluded that the 
district court abused its discretion in not considering 
what the court of appeals described as the “strong 
public interest in the availability of a doctor-prescribed 
treatment that would help ameliorate the condition and 
relieve the pain and suffering of a large group of 
persons with serious or fatal illness.” App. 9a-10a. 
“Indeed,” the court observed, “the City of Oakland has 
declared a public health emergency” in response to the 
district court’s denial of OCBC’s motion to modify the 
injunction to authorize it to distribute marijuana. Id. at 
10a. The court also expressed the view that “[t]he evi- 
dence in the record is sufficient to justify the requested 
modification,” and the court had “no doubt that the 
district court could have modified its injunction, had it 
determined to do so in the exercise of its equitable dis- 
cretion.” Id. at 10a. “[B]y contrast,” the court con- 
tinued, the government had identified no “interest it 
may have in blocking the distribution of cannabis to 
those with medical needs, relying exclusively on its 
general interest in enforcing statutes.” Id. at 11a. The 
court of appeals therefore remanded the matter to the 
district court “to reconsider” OCBC’s request for a 
modification of the injunction to allow OCBC to 

5 

distribute marijuana to persons who would satisfy 
OCBC’s proposed test of medical necessity. Ibid.5 

3. Following the Ninth Circuit’s decision, on May 30, 
2000, OCBC filed a motion with the district court to 
modify the district court’s injunction entered on May 
19, 1998. On July 17, 2000, the district court granted 
OCBC’s motion. App. 12a-17a. The court explained: 

On remand the government has still not offered 
any evidence to rebut [OCBC’s] evidence that can- 
nabis is medically necessary for a group of seriously 
ill individuals. Instead, the government continues to 
press arguments which the Ninth Circuit rejected, 
including the argument that the Court must find 
that enjoining the distribution of cannabis to seri- 
ously ill individuals is in the public interest because 
Congress has prohibited such conduct in favor of the 
administrative process regulating the approval and 
distribution of drugs. 

Id. at 13a. The court therefore stated that, “[a]s a 
result of the government’s failure to offer any new 
evidence in opposition to [OCBC’s] motion, and in light 
of the Ninth Circuit’s opinion, the Court must conclude 

5 On May 10, 2000, the Ninth Circuit issued an order vacating 
and remanding the district court’s February 25, 1999, order dis- 
missing the counterclaims for injunctive and declaratory relief 
sought by individual intervenors who alleged that the preliminary 
injunction violated their asserted substantive due process rights to 
use cannabis to alleviate their medical conditions. The court of 
appeals reasoned that, “[a]lthough the substantive claim of viola- 
tion of Fifth Amendment rights that underlies plaintiffs’ claim in 
this appeal differs from the defense of medical necessity upon 
which we ruled in the earlier appeal, the injunctive remedy in- 
volved in both appeals is similar.” United States v. Oakland 
Cannabis Buyers’ Coop., No. 99-15838, 2000 WL 569509, at *1 (9th 
Cir.). 

6 

that modifying the injunction as requested is in the 
public interest” and that it would “exercise its equitable 
discretion to do so.” Ibid. 

The district court accordingly issued an amended 
preliminary injunction order, which reaffirmed that 
OCBC was preliminarily enjoined from manufacturing, 
distributing, or possessing marijuana with the intent to 
manufacture or distribute it, in violation of 21 U.S.C. 
841(a)(1). App. 15a-16a. The district court further 
ordered, however, that 

[t]he foregoing injunction does not apply to the dis- 
tribution of cannabis by [OCBC] to patient-members 
who (1) suffer from a serious medical condition, (2) 
will suffer imminent harm if the patient-member 
does not have access to cannabis, (3) need cannabis 
for the treatment of the patient-member’s medical 
condition, or need cannabis to alleviate the medical 
condition or symptoms associated with the medical 
condition, and (4) have no reasonable legal alterna- 
tive to cannabis for the effective treatment or alle- 
viation of the patient-member’s medical condition or 
symptoms associated with the medical condition be- 
cause the patient-member has tried all other legal 
alternatives to cannabis and the alternatives have 
been ineffective in treating or alleviating the pa- 
tient-member’s medical condition or symptoms as- 
sociated with the medical condition, or the alterna- 
tives result in side effects which the patient-mem- 
ber cannot reasonably tolerate. 

Id. at 16a-17a. 

On July 18, 2000, the district court denied the gov- 
ernment’s motion for a stay of the court’s July 17, 2000, 
modification order pending appeal. 

7 

REASONS FOR GRANTING THE PETITION 

The Ninth Circuit has held that medical necessity is a 
“legally cognizable defense” to a charge of distributing 
drugs in violation of the Controlled Substances Act. 
App. 8a. The court has further held that district courts 
have the “equitable discretion” to fashion an injunction 
to permit an organization to engage in the ongoing 
distribution of marijuana, wholly outside the strict 
controls imposed by the CSA, to individuals claiming a 
medical necessity for the drug. App. 10a. 

The conclusion that a court may exempt certain 
persons or transactions from the operation of the CSA, 
based on the view of those persons or the court on 
whether marijuana has some medical utility, cannot be 
squared with the judgment Congress itself made in 
placing marijuana in Schedule I, which applies to 
substances that have been authoritatively found under 
the CSA to have a “high potential for abuse,” “no cur- 
rently accepted medical use in treatment in the United 
States,” and “a lack of accepted safety for use * * * 
under medical supervision.” 21 U.S.C. 812(b)(1). Nor 
can the court of appeals’ decision be squared with Con- 
gress’s recent statutory declaration that it “continues 
to support the existing Federal legal process for deter- 
mining the safety and efficacy of drugs and opposes 
efforts to circumvent this process by legalizing mari- 
juana, and other Schedule I drugs, for medicinal use 
without valid scientific evidence and the approval of the 
Food and Drug Administration.” 

Pub. L. No. 105-277, 
Div. F, 112 Stat. 2681-760 to 2681-761. Congress has 
assigned to the Attorney General and the Secretary of 
Health and Human Services, under prescribed stan- 
dards and administrative procedures set forth in the 
CSA, the responsibility to determine whether the 

8 

manufacture and distribution of marijuana and other 
drugs should be permitted for specified medical pur- 
poses. It has not left that determination to individual 
courts or juries—much less to private organizations like 
the Oakland Cannabis Buyers’ Cooperative. 

Whether asserted medical necessity exempts the 
distribution of marijuana (and other drugs) from strict 
controls under the CSA is an issue of exceptional and 
continuing importance. By sanctioning the prospective 
distribution of marijuana under a common law defense 
of necessity, the Ninth Circuit’s holding flouts the 
provisions of the CSA banning the distribution of 
marijuana outside strictly controlled circumstances and 
undermines the enforcement of the federal drug laws. 
It also opens the way for producers, distributors, or 
users of other drugs and devices not approved by the 
FDA to invoke “medical necessity” as a defense to 
enforcement of the nation’s health and safety laws. 
The court of appeals’ decision therefore warrants this 
Court’s review. 

1. a. The court of appeals seriously erred in holding 
that medical necessity is a defense under the CSA, and 
in further holding that a district court has the equitable 
discretion to fashion an injunction that would permit 
the distribution of marijuana for medicinal purposes 
wholly outside the strict regulatory regime of the CSA. 
A common law defense of necessity is available only 
“when a real legislature would formally do the same 
under those circumstances.” United States v. Schoon, 
971 F.2d 193, 197 (9th Cir. 1991), cert. denied, 504 U.S. 
990 (1992). See also 1 Walter LaFave & Austin W. 
Scott, Jr., Substantive Criminal Law § 5.4, at 629 (1986) 
(“The defense of necessity is available only in situations 
wherein the legislature has not itself, in its criminal 

9 

statute, made a determination of values. If it has done 
so, its decision governs.”). 

The text, structure, and purposes of the CSA all 
compel the conclusion that Congress expressly has 
rejected the notion that an individual who claims a 
medical necessity for marijuana is exempted from the 
Act’s prohibitions on the manufacture, distribution, or 
dispensing of marijuana. The text of the CSA makes it 
unlawful to “manufacture, distribute, or dispense, or 
possess with intent to manufacture, distribute, or dis- 
pense’ ” any controlled substance, “[e]xcept as author- 
ized by [21 U.S.C. 801-904].” 21 U.S.C. 841(a)(1); see 
also United States v. Moore, 423 U.S. 122, 131, 135 
(1975). Since the enactment of the CSA in 1970, 
marijuana has been classified as a Schedule I controlled 
substance, a classification which means that marijuana 
has been found to have a “high potential for abuse,” “no 
currently accepted medical use in treatment in the 
United States,” and “a lack of accepted safety for use 

* * * under medical supervision.” 21 U.S.C. 812(b)(1). 
The CSA also establishes a closed system of dis- 
tribution for Schedule I controlled substances. No phy- 
sician or pharmacy may dispense a Schedule I con- 
trolled substance to any patient outside 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 and 
1301.32; 28 C.F.R. 0.100(b). By contrast, physicians and 
pharmacies may lawfully distribute controlled sub- 
stances in Schedules II through V consistent with their 
DEA registration. 21 U.S.C. 829. Even for substances 
listed in Schedules II through V, however, the Act does 
not allow the essentially unregulated manufacture and 
distribution that the Ninth Circuit has countenanced 

10 

for marijuana, a Schedule I controlled substance. See 
21 U.S.C. 822-829. 

In addition, the CSA establishes an exclusive set of 
statutory procedures under which controlled sub- 
stances that have been placed in Schedule I (or any 
other schedule) may be transferred between, or re- 
moved from, the five schedules, based on changes in 
scientific knowledge. 21 U.S.C. 811(a). Pursuant to 
that process, “any interested party” who believes that 
medical, scientific, or other relevant data warrant 
transferring marijuana to a less restrictive schedule 
may petition the Administrator of the DEA to initiate a 
rulemaking proceeding to reschedule marijuana. 21 
U.S.C. 811(a); 21 C.F.R. 1308.43. The Administrator, 
acting on behalf of the Attorney General, must refer 
any rescheduling petition to the Secretary of Health 
and Human Services for a medical and scientific 
evaluation, which is binding on the Administrator. 21 
U.S.C. 811(b). Any party aggrieved by a final decision 
of the Administrator may seek review in the court of 
appeals. 21 U.S.C. 877; see, e.g., Alliance for Cannabis 
Therapeutics v. DEA, 15 F.3d 1131, 1137 (D.C. Cir. 
1994) (upholding Administrator’s decision declining to 
remove marijuana from the list of Schedule I controlled 
substances). Based on that framework, the courts of 
appeals uniformly have held that the statutory re- 
scheduling process is the exclusive means by which to 
challenge marijuana’s placement in Schedule I.6 

6 United States v. Burton, 894 F.2d 188, 192 (6th Cir.), cert. 
denied, 498 U.S. 857 (1990); United States v. Greene, 892 F.2d 453, 
455-456 (6th Cir. 1989), cert. denied, 495 U.S. 935 (1990); United 
States v. Wables, 731 F.2d 440, 450 (7th Cir. 1984); United States v. 
Fogarty, 692 F.2d 542, 548 (8th Cir. 1982), cert. denied, 460 U.S. 
1040 (1983); United States v. Middleton, 690 F.2d 820, 823 (11th 

11 

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

(1) certain drugs are listed on Schedule I of the 
Controlled Substances Act if they have a high 
potential for abuse, lack any currently accepted 
medical use in treatment, and are unsafe, even 
under medical supervision; 

* * * * * 

(3) pursuant to section 401 of the Controlled 
Substances Act, it is illegal to manufacture, distri- 
bute, or dispense marijuana * * *; 

(4) pursuant to section 505 of the Federal 
Food, Drug and Cosmetic Act, before any drug can 
be approved as a medication in the United States, it 
must meet extensive scientific and medical stan- 
dards established by the Food and Drug Admini- 
stration to ensure it is safe and effective; 

(5) marijuana and other Schedule I drugs have 
not been approved by the Food and Drug Ad- 
ministration to treat any disease or condition; 

(6) the Federal Food, Drug and Cosmetic Act 
already prohibits the sale of any unapproved drug, 
including marijuana, that has not been proven safe 
and effective for medical purposes and grants the 
Food and Drug Administration the authority to 
enforce this prohibition through seizure and other 
civil action, as well as through criminal penalties; 

Cir. 1982), cert. denied, 460 U.S. 1051 (1983); United States v. 
Kiffer, 477 F.2d 349, 357 (2d Cir.), cert. denied, 414 U.S. 831 (1973). 

12 

* * * * * 

(11) Congress continues to support the existing 
Federal legal process for determining the safety and 
efficacy of drugs and opposes efforts to circumvent 
this process by legalizing marijuana, and other 
Schedule I drugs, for medicinal use without valid 
scientific evidence and the approval of the Food and 
Drug Administration. 

Pub. L. No. 105-277, Div. F, 112 Stat. 2681-760 to 
2681-761 (reprinted at App. 89a-92a).7 That legislation 
reaffirms Congress’s continuing adherence to the 
existing FDA drug-approval process, and its continuing 
opposition to any effort to allow the medicinal use of 
marijuana or other Schedule I controlled substances 
until they are proven safe and effective based on ap- 
propriate findings by the FDA. See, e.g., Accardi v. 
Pennsylvania R.R. Co., 383 U.S. 225, 229 (1966) (con- 
tinuing purpose of Congress reflected in “sense of Con- 
gress” enactment); Harris v. United States, 359 U.S. 19, 
22 n.8 (1959) (continuing purpose of Congress reflected 
in subsequently-enacted legislation). 

Those provisions leave no doubt that, had Congress 
considered whether an individual claiming a medical 
need for marijuana could violate the CSA with 
impunity, Congress would have answered the question 

7 The legislation was prompted by state initiatives around the 
country to legalize marijuana for medicinal uses. The provision’s 
sponsor, Representative McCullom, explained that the provision 
“is important” because, inter alia, “[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 144 Cong. Rec. S10,666 (daily ed. Sept. 21, 
1998). 

13 

with a resounding “no.” Yet in recognizing the avail- 
ability of a medical necessity defense, the court of 
appeals has sanctioned the use of marijuana for 
medicinal purposes. That decision is directly at odds 
with Congress’s express finding that marijuana has “no 
currently accepted medical use.” 

21 U.S.C. 812(b)(1). 
It also is inconsistent with the exclusive procedures 
under the CSA for the removal of marijuana from the 
list of Schedule I controlled substances in order to allow 
its use for medical purposes under specified conditions. 
21 U.S.C. 811; cf. United States v. Bailey, 444 U.S. 394, 
410 (1980) (noting that a necessity defense is 
unavailable “if there was a reasonable, legal alternative 
to violating the law”). 

Finally, the recognition of a medical necessity 
defense runs counter to the absolute ban on the distri- 
bution of marijuana and other Schedule I controlled 
substances outside a DEA-registered and FDA- 
approved research project. 21 U.S.C. 823(f); see also 21 
U.S.C. 841(a)(1) (making the distribution and dis- 
pensing of controlled substances unlawful “[e]xcept as 
authorized” by the CSA); United States v. Moore, 423 
U.S. at 131. Indeed, the Ninth Circuit’s decision 
permits the distribution of marijuana under judicial 
imprimatur without any of the stringent limitations 
that Congress placed on the manufacture and distri- 
bution of controlled substances, even those listed in 
Schedules II through V. The CSA and the governing 
regulations require manufacturers, distributors, and 
dispensers of controlled substances to register with the 
DEA, 21 U.S.C. 822(a), 823, 21 C.F.R. 1301, and to 
establish effective controls to guard against the theft 
and diversion of controlled substances, 21 C.F.R. 
1301.71-1301.76; authorize the Attorney General to 
inspect a registrant’s establishment, 21 U.S.C. 822(f), 

14 

880; require the Attorney General to determine pro- 
duction quotas for Schedule I and II controlled sub- 
stances, 21 U.S.C. 826, 21 C.F.R. 1303; impose 
substantial record-keeping and reporting requirements 
on registrants, 21 U.S.C. 827, 21 C.F.R. 1304; disallow 
the distribution of Schedule I and II drugs except 
pursuant to an order form issued by the DEA, 21 
U.S.C. 828, 21 C.F.R. 1305; and establish prescription 
requirements for the dispensing of controlled sub- 
stances in Schedules II through V, 21 U.S.C. 829, 21 
C.F.R. 1306. The Ninth Circuit’s recognition of a 
medical necessity defense cannot be squared with 
Congress’s considered judgment that the threat to 
public health and safety mandates a complete ban on 
the manufacture and distribution of controlled 
substances outside the express terms of the CSA. 

In United States v. Rutherford, 442 U.S. 544 (1979), 
this Court considered an analogous issue and held that 
a claim of medical need for a drug cannot override Con- 
gress’s judgment that the drug not be distributed 
absent a finding by the FDA under the statutory 
framework that the drug is generally recognized by 
experts as safe and effective. In Rutherford, a class of 
terminally ill cancer patients and their spouses brought 
suit to enjoin the government from interfering with the 
interstate shipment and sale of Laetrile, a drug that 
had not been approved by the FDA under the Food, 
Drug, and Cosmetic Act (FDCA). The district court 
granted the requested relief, and the Tenth Circuit 
affirmed, holding that the safety and effectiveness 
protections of the FDCA had no reasonable application 
to terminally ill cancer patients since those patients, by 
definition, would die of cancer regardless of their 
treatment. Id. at 548-549. The Court unanimously 
reversed. The Court rejected the Tenth Circuit’s 

15 

determination that an exemption from the FDCA was 
justified because the safety and effectiveness standards 
could have no reasonable application to terminally ill 
cancer patients, explaining that, “[u]nder our constitu- 
tional framework, federal courts do not sit as councils of 
revision, empowered to rewrite legislation in accord 
with their own conceptions of prudent public policy. 

* * * Whether, as a policy matter, an exemption 
should be created is a question for legislative judgment, 
not judicial inference.” Id. 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 construing a statute so explicit in scope,” it is 
incumbent upon courts to give it effect. Id. at 551. 

The Court’s holding and reasoning in Rutherford 
apply with equal force to the CSA, whose text, struc- 
ture, and paramount policies evince Congress’s intent 
to ban the distribution of marijuana, even for medicinal 
purposes. Indeed, every court to have considered the 
issue has rejected the invocation of a medical necessity 
defense under the CSA. See United States v. Burton, 
894 F.2d 188, 191 (6th Cir.) (concluding the defense 
was not available because the defendant could have 
attempted to participate in a government-approved 
program to study the effects of marijuana on glaucoma 
sufferers), cert. denied, 498 U.S. 857 (1990); United 
States v. Belknap, No. 92-5363, 1993 WL 30375, at **2 
(4th Cir. Feb. 10, 1993) (unpublished) (concluding that 
there was “no legal or factual basis” for a medical 
necessity defense to marijuana prosecution); United 
States v. McWilliams, No. CR 97-997(A)-GHK (C.D. 
Cal. Nov. 5, 1999), slip op. 2-3 (“Because Congress has 
already determined that there is no accepted medical 
use for marijuana, * * * we conclude as a matter of 
law that the medical necessity defense is not available 

16 

in this case.”); United States v. Lederer, No. CR-97-558 
GEB (E.D. Cal. May 21, 1999), slip op. 5-9 (“Since the 
weighing of values required for the defense of necessity 
has already been conducted by Congress’ proscription 
of the very acts [the defendant] sought to legitimize 
through his assertion of the defense, [the defendant’s] 
motion is denied.”); United States v. Diana, No. CR-98- 
068-RHW (E.D. Wash. Sept. 21, 1998), slip op. 5 
(rejecting medical necessity defense because “Congress 
was aware of the competing interests in cases such as 
Defendants’ and addressed them”); United States v. 
Allerheilgen, No. 97-40090-01-DES, 1998 WL 918841 
(D. Kan. Nov. 19, 1998) (same).8 

b. In reaching the contrary holding that medical 
necessity is a “legally cognizable defense,” the court of 
appeals did not attempt to reconcile a medical necessity 
defense with either the text of the CSA or the 1998 
legislation disapproving any attempt to legalize mari- 
juana for medicinal use outside the existing framework 

8 State courts that have construed state drug laws are divided 
on whether a medical necessity defense is available in a marijuana 
prosecution under those laws. Eight state courts have held that 
the defense is unavailable. State v. Poling, No. 26658, 2000 WL 
572334, *7-*8 (W. Va. May 8, 2000); State v. Ownbey, 996 P.2d 510 
(Or. Ct. App. 2000); State v. Williams, 968 P.2d 26 (Wash. Ct. App. 
1998), review denied, 984 P.2d 1034 (1999); Murphy v. Common- 
wealth, 521 S.E.2d 301, 302-303 (Va. Ct. App. 1999); State v. Tate, 
505 A.2d 941, 946 (N.J. 1986); State v. Cramer, 851 P.2d 147, 149 
(Ariz. Ct. App. 1992); Kauffman v. State, 620 So. 2d 90, 92-93 (Ala. 
Crim. App. 1992); State v. Hanson, 468 N.W.2d 77, 78 (Minn. Ct. 
App. 1991). By contrast, four state courts have recognized the 
availability of the defense. See State v. Bachman, 595 P.2d 287, 
288 (Haw. 1979); State v. Hastings, 801 P.2d 563, 565 (Idaho 1990); 
Jenks v. State, 582 So. 2d 676, 678-679 (Fla. Dist. Ct. App.), review 
denied, 589 So. 2d 292 (1991); State v. Christen, 704 A.2d 335, 337 
(Me. 1997). 

17 

of the CSA and the FDCA. Rather, the court of 
appeals explained that it saw “no indication that the 
‘underlying substantive policy’ of the [CSA] mandates a 
limitation on the district court’s equitable powers” “to 
formulate appropriate relief when and if injunctions are 
sought.” App. 9a. The court of appeals took the view 
that the district court abused its discretion first in 
failing to consider what it deemed the “strong public 
interest” in the availability of marijuana for medicinal 
purposes, and second in finding that an injunction 
against marijuana distribution could not be supported 
by the government’s “general interest in enforcing its 
statutes.” Id. at 9a, 11a. 

Those conclusions, however, cannot be reconciled 
with this Court’s precedents concerning the limits of a 
district court’s equitable discretion in fashioning an 
injunction. This Court has long held that a district 
court sitting in equity cannot “ignore the judgment of 
Congress” that is “deliberately expressed in legisla- 
tion.” Virginia Ry. Co. v. System Fed’n No. 40, 300 
U.S. 515, 551 (1937). Likewise, in Hecht Co. v. Bowles, 
321 U.S. 321, 331 (1944), the Court held that, where 
injunctive relief is sought pursuant to a statutory 
mandate, a court’s equitable discretion must reflect the 
“large objectives” of the statute, “[f ]or the standards of 
the public interest, not the requirements of private 
litigation, measure the propriety and need for injunc- 
tive relief.” This principle was reaffirmed in TVA v. 
Hill, 437 U.S. 153, 194 (1978), in which the Supreme 
Court held that, in examining whether to enter injunc- 
tive relief, a court must be mindful that 

it is * * * emphatically * * * the exclusive 
province of the Congress not only to formulate 
legislative policies and mandate programs and 

18 

projects, but also to establish their relative priority 
for the Nation. Once Congress, exercising its dele- 
gated powers, has decided the order of priorities in a 
given area, it is for the Executive to administer the 
laws and for the courts to enforce them when 
enforcement is sought. 

See also Miller v. French, No. 99-224 (June 19, 2000), 
slip op. 11. 

Those principles dictate the conclusion that a district 
court lacks the discretion, based on its own perception 
of the public interest and its own weighing of possible 
medical benefits against the potential for abuse, to craft 
an injunction under the CSA which exempts from the 
injunction’s reach the distribution of marijuana for 
medicinal purposes. Congress already has considered 
the public interest, balanced the relevant medical and 
other considerations, and concluded that, unless and 
until the DEA removes marijuana from Schedule I, the 
drug has no “accepted medical use” and a “high poten- 
tial for abuse” (21 U.S.C. 812(b)(1)) and may not be 
manufactured, distributed, or dispensed outside of a 
program of research approved by the FDA and con- 
ducted by a practitioner registered with the DEA (21 
U.S.C. 841(a), 823(f )). The Ninth Circuit therefore 
plainly erred in holding that a district court has the 
equitable discretion to modify its injunction based on a 
claimed public interest in distributing marijuana to 
those who claim to have a medical need for it. 

2. a. The issue of whether the CSA forecloses the 
availability of a medical necessity defense is one of 
exceptional and continuing importance. For the first 
time, a court of appeals has ruled that persons and enti- 
ties may lawfully engage in the distribution of mari- 
juana if, in their view, the recipients of the marijuana 

19 

medically need the drug. That holding flouts the CSA’s 
ban on the distribution of Schedule I controlled sub- 
stances unless the distributor is registered with the 
DEA and conducting research approved by the FDA. 
See 21 U.S.C. 823(f ). The court of appeals’ decision 
likewise circumvents the Act’s exclusive provisions for 
drug approval and rescheduling of controlled sub- 
stances. See 21 U.S.C. 811, 812. And the decision rele- 
gates to district courts and juries the power to deter- 
mine whether illicit drugs can be used safely and 
effectively as medicine, even though Congress in the 
CSA placed such determinations within the province of 
the Attorney General and the Secretary of Health and 
Human Services. Thus, the Ninth Circuit’s decision 
seriously undermines the administration and effective- 
ness of the CSA. 

The decision is also significant because it threatens 
the government’s ability to enforce the federal drug 
laws in the nine States within the Ninth Circuit, which 
comprises a population of nearly 50 million people. U.S. 
Dep’t of Commerce, Statistical Abstract of the United 
States (1994). Indeed, the Ninth Circuit’s sanctioning of 
the distribution of controlled substances in a manner 
that the CSA expressly prohibits creates incentives for 
drug manufacturers and distributors involved in a wide 
variety of offenses involving marijuana (and other 
Schedule I controlled substances, such as heroin or 
LSD) to invoke medical necessity as a defense to their 
alleged drug trafficking. The recognition of such a 
defense will introduce illegitimate collateral issues into 
drug prosecutions and will consume unnecessary 
judicial resources by distracting the trier of fact from 
the core issues of guilt or innocence of a particular 
crime as defined by Congress in the CSA. 

20 

For example, in a recent case prosecuted in the 
Eastern District of California, a motions panel of the 
Ninth Circuit reversed a district court’s order denying 
bail pending appeal, holding that, in view of the Ninth 
Circuit’s decision in this case, the defendant, a dis- 
tributor of marijuana, was “entitled to bail pending 
appeal if he can demonstrate: 1) a likelihood that he 
was entitled to present a medical necessity defense at 
trial; and 2) his release does not pose a danger that he 
will distribute marijuana to people not falling within 
the class of individuals described in OCBC.” United 
States v. Smith, No. 99-10447 (9th Cir. Feb. 3, 2000), 
slip op. 1-2. 

The court of appeals’ recognition of a medical neces- 
sity defense also takes on added significance in light of 
the fact that a number of States in the Ninth Circuit— 
Alaska, California, Hawaii, Oregon, and Washington— 
have enacted legislation sanctioning the use of mari- 
juana for medicinal purposes. See Alaska Stat. 
§§ 17.37.010-17.37.080 & 11.71.090 (1999); Cal. Health & 
Safety Code § 11362.5(b)(1)(A) and (d); Haw. S.B. 862, 
20th Legis. (1999) (signed into law on July 12, 2000); Or. 
Rev. Stat. §§ 475.300-475.346 (1999); Wash. Rev. Code 
§§ 69.51.010-69.51.080 (1997).9 In those States, there is 
therefore no state law that would independently bar 

9 A medical marijuana ballot measure likewise was approved 
by voters in Maine in November 1999. Carey Goldberg, Maine 
Mulls Medical Use for its Seized Marijuana, N.Y. Times, Mar. 14, 
2000 at Nat’l Desk. We have been informed by the DEA that 
medical marijuana initiatives are underway in Arizona, Nevada, 
Colorado, Iowa, Maryland, Massachusetts, Minnesota, New 
Hampshire, and New York. A majority of voters in the District of 
Columbia also approved a marijuana initiative in November 1998, 
but Congress blocked implementation of that initiative. See 145 
Cong. Rec. H12,238 (daily ed. Nov. 17, 1999). 

21 

the distribution of marijuana in the circumstances that 
the Ninth Circuit has sanctioned. Thus, unless the CSA 
can be enforced with respect to that distribution, drug 
traffickers, acting under the guise of “medical 
necessity,” will be able to manufacture and distribute 
marijuana with impunity, even though the CSA reflects 
Congress’s deliberate judgment that marijuana shall 
not be used for medicinal purposes outside the specific 
confines of the Act itself. 

Finally, the Ninth Circuit’s decision threatens the 
government’s more general ability to enforce the fed- 
eral drug laws with respect to other illegal and un- 
approved drugs. As this Court recognized in Ruther- 
ford: 

It bears emphasis that although the Court of 
Appeals’ ruling was limited to Laetrile, its rea- 
soning cannot be so readily confined. To accept the 
proposition that the safety and efficacy standards of 
the Act have no relevance for terminal patients is to 
deny the Commissioner’s authority over all drugs, 
however toxic or ineffectual, for such individuals. If 
history is any guide, this new market would not be 
long overlooked. 

442 U.S. at 557-558. That reasoning is equally applica- 
ble in this case. Under the Ninth Circuit’s analysis, 
there is no reason that a defendant charged with of- 
fenses involving other Schedule I controlled substances 
or unapproved drugs—such as Laetrile—would not 
similarly be able to raise the defense of “medical 
necessity.” The Ninth Circuit’s decision therefore 
could significantly undermine the enforcement of the 
federal drug laws and the FDA drug-approval process, 
a result patently at odds with the statutory framework 

22 

that Congress has enacted. The court of appeals’ 
decision therefore warrants this Court’s review. 

b. No further proceedings in the lower courts are 
needed to clarify the issues presented or to render the 
case suitable for resolution by this Court. As explained 
above, the Ninth Circuit held: (a) that medical neces- 
sity is a “legally cognizable defense” to a marijuana 
prosecution or a suit for an injunction against marijuana 
distribution, App. 8a; (b) that OCBC had “identified a 
strong public interest in the availability of a doctor- 
prescribed treatment [of marijuana] that would help 
ameliorate the condition and relieve the pain and 
suffering of a large group of persons with serious or 
fatal illnesses,” id. at 9a-10a; and (c) that the 
government, which had “rel[ied] exclusively on its 
general interest in enforcing its statutes,” had identi- 
fied no “interest * * * in blocking the distribution of 
marijuana to those with medical needs,” id. at 11a. To 
be sure, the court of appeals did not order the injunc- 
tion modified to permit the distribution of marijuana, 
but rather referred the case to the district court for a 
determination whether the injunction should be 
modified in that respect. On remand, however, the 
district court granted OCBC’s request to modify the 
injunction, and did so “in light of the Ninth Circuit’s 
opinion. ” Id. at 13a. Thus, no further factual develop- 
ment is needed for this Court to resolve the legal issues 
presented. 

Moreover, there is no reason to await an appeal of the 
district court’s modification order in order to clarify the 
question presented. Although the government has filed 
a notice of appeal from the district court’s July 17, 2000, 
order modifying the injunction, there is no reason to 
believe that the Ninth Circuit panel, which has retained 
jurisdiction over any appeal, App. 11a, will revisit its 

23 

fundamental holding that medical necessity is a legally 
cognizable defense that justifies violating the CSA— 
especially since the Ninth Circuit declined to reconsider 
that holding on the government’s petition for rehearing 
and rehearing en banc. 

Finally, with respect to the circumstances of this 
case, the court of appeals has already determined that 
“[t]he evidence in the record is sufficient to justify the 
requested modification.” App. 10a. Indeed, the court of 
appeals stated that it had “no doubt that the district 
court could have modified its injunction, had it deter- 
mined to do so in the exercise of its equitable discre- 
tion.” Ibid. Given the terms of the court of appeals’ 
remand, and the district court’s actual modification of 
the injunction, further proceedings are unlikely to 
assist this Court in its review of the basic legal issues 
presented. And at the same time, to postpone review of 
the Ninth Circuit’s holding would only exacerbate its 
adverse consequences by encouraging broad disregard 
of the Controlled Substances Act and the unregulated 
distribution of marijuana, with the attendant serious 
potential for abuse Congress sought to prevent by 
placing marijuana in Schedule I under the Act. 

24 

CONCLUSION 

The petition for a writ of certiorari should be 
granted. 

Respectfully submitted. 

SETH P. WAXMAN 

Solicitor General 

DAVID W. OGDEN 

Acting Assistant Attorney 

General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

LISA SCHIAVO BLATT 

Assistant to the Solicitor 

General 

JULY 2000