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 

REPLY BRIEF FOR THE PETITIONER 

SETH P. WAXMAN 

Solicitor General 

Counsel of Record 
Department of Justice 
Washington, D.C. 20530-0001 
(202) 514-2217 

TABLE OF AUTHORITIES 

Cases: Page 

Hecht Co. v. Bowles, 321 U.S. 321 (1944) ....................... 
8-9, 10 

Miller v. French, 120 S. Ct. 2246 (2000) ............................ 
9 

TVA v. Hill, 437 U.S. 153 (1978) ......................................... 
9 

United States v. Bailey, 444 U.S. 394 (1980) .................... 
7 

United States v. Rutherford, 442 U.S. 544 
(1979) ........................................................................................ 8 

Virginian Ry. v. System Fed’n No. 40, 300 U.S. 515 
(1937) ........................................................................................ 9 

Weinberger v. Romero-Barcelo, 456 U.S. 305 
(1982) ........................................................................................ 

8, 9 

Constitution, statutes and regulations: 

U.S. Const.: 

Amend. IX .............................................................................. 

3 

Amend. X ................................................................................ 
3 

Act of Oct. 21, 1998, Pub. L. No. 105-277, Div. F, 
112 Stat. 2681-2761 ................................................................ 
8 

Controlled Substances Act, 21 U.S.C. 801 et seq.: 
21 U.S.C. 801(2) ...................................................................... 
10 

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

21 U.S.C. 811 ........................................................................... 
1 

21 U.S.C. 811-812 ................................................................... 
7 

21 U.S.C. 812 ........................................................................... 
1, 6 

21 U.S.C. 812(b)(1) ................................................................. 
6 

21 U.S.C. 812(b)(2)-(5) ........................................................... 
7 

21 U.S.C. 821-829 ................................................................... 
1, 7 

21 U.S.C. 823(f) ....................................................................... 
1, 7 

21 U.S.C. 829 ........................................................................... 
1, 7 

21 U.S.C. 841(a)(1) .................................................................. 1, 7, 10 

21 U.S.C. 885(d) ...................................................................... 

3 

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
301 et seq. ................................................................................. 4, 8 

(I) 

II 

Regulations—Continued: Page 

21 C.F.R.: 

Pt. 5: 

Section 5.10(a)(9) .............................................................. 
1 

Pts. 1301-1306 ......................................................................... 
7 

Section 1301.18 .................................................................. 
1 

Section 1301.32 .................................................................. 
1 

28 C.F.R. 0.100.(b) .................................................................... 
1 

Miscellaneous: 

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

6 

Model Penal Code (1962) ......................................................... 
7 

Martin Kasindorf, Medicinal Pot Use Set Back, USA 

Today, Aug. 30, 2000 ............................................................. 

5 

Jean Merl, Marijuana Distribution Ban Alarms 

Patients, Los Angeles Times, Aug. 31, 2000 .................... 

5 

Ulysses Torassa, City’s Pot Clubs Live On, 

San Francisco Examiner, June 13, 1999 ........................... 

5 

Holly J. Wolcott, Marijuana Club Members Support 

Four Arrested Activists, Los Angeles Times, 
Aug. 9, 2000 ............................................................................. 5 

REPLY BRIEF FOR THE PETITIONER 

The Ninth Circuit has held that medical necessity is a 
“legally cognizable defense” to a charge of distributing mari- 
juana, a Schedule I controlled substance, in violation of 
the Controlled Substance Act (CSA), and that district courts 
have “equitable discretion” to permit an organization to en- 
gage in the ongoing distribution of marijuana, wholly outside 
the Act’s strict controls, to individuals claiming a medical 
need for the drug. Pet App. 8a, 10a. Those unprecedented 
holdings are fundamentally wrong and warrant review. 

1. a. 

As we demonstrate in our certiorari petition (at 18- 

20), the court of appeals’ decision warrants this Court’s re- 
view because it significantly undermines the effectiveness of 
the CSA and threatens the government’s ability to enforce 
an Act of Congress that is central to combating illicit drug 
trafficking. By listing marijuana as a Schedule I controlled 
substance, Congress has categorically banned the distri- 
bution 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 distributor is registered 
with the DEA and is conducting research approved by 
the 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). That categorical ban may be 
modified only if the Attorney General, after following the 
exclusive procedures set forth in the CSA, transfers mari- 
juana from Schedule I to another schedule, or removes mari- 
juana altogether from the CSA. See 21 U.S.C. 811, 812, 829. 

The Ninth Circuit’s decision flouts those provisions, and 
goes even further by permitting the open and notorious 
distribution of marijuana wholly outside the Act’s stringent 
controls, which mandate that any person who dispenses any 
controlled substance—even substances listed in Schedules II 
through V—must register with the DEA, establish security 
controls, and comply with record-keeping, reporting, order- 
form, and prescription requirements. See 21 U.S.C. 821-829. 

(1) 

2 

And, finally, the Ninth Circuit’s decision places no limitation 
whatsoever on the quantity of marijuana that respondent or 
others similarly situated may distribute, either in the 
aggregate or to particular customers, or the number of 
people to whom respondents and others may distribute 
marijuana under the guise of “medical necessity.” The 
decision thus has enormous legal and practical importance. 

b. In opposing certiorari, respondents argue (Br. in Opp. 
8-13) that the legal issues involved will not be ripe for this 
Court’s review until the Ninth Circuit has disposed of the 
government’s appeal of the district court’s July 17, 2000, 
orders on remand, which modified the district court’s May 
19, 1998, injunction to permit respondents to distribute mari- 
juana to persons claiming a medical necessity for the drug. 
Pet. App. 12a-17a.1 As we explain in the certiorari petition 
(at 22-23), however, no further factual development or 
proceedings are needed for this Court to render a definitive 
resolution of the case. Our petition presents the purely legal 
question whether the CSA forecloses a medical necessity 
defense to a violation of the Act. Pet. i. Contrary to peti- 
tioner’s contention (Br. in Opp. 12), the Ninth Circuit did not 
address that issue “only indirectly and tangentially.” 
Rather, it held that (1) medical necessity is a “legally cogni- 
zable defense” under the Act, Pet. App. 8a, and that (2) a 
supposed “public interest” in the availability of marijuana for 
asserted medical uses outweighs the government’s “general 
interest in enforcing” the CSA, id. at 9a, 11a. There is no 
reason to believe that the same Ninth Circuit panel, which 
has retained jurisdiction over any appeal, id. at 11a, will 

1 Although respondents have requested that the Ninth Circuit ex- 
pedite its resolution of the government’s appeal (Br. in Opp. 2), the court 
has neither acted on that request nor indicated when it will issue its 
decision. 

3 

revisit those conclusions.2 
Indeed, that court has already 

determined that “[t]he evidence in the record [on the first 
appeal] is sufficient to justify the requested modification,” 
and that it had “no doubt” the district court could have 
modified the injunction on the basis of that evidence had it 
chosen to do so. Id. at 10a. 

Contrary to respondents’ contention (Br. in Opp. 8), there 
is no reason to postpone review to allow the Ninth Circuit to 
consider “new evidence” that patients have a medical need 
for marijuana or that the City of Oakland has declared that 
there is a “medical emergency” for marijuana. Those asser- 
tions were before the court of appeals when it rendered the 
decision we seek to have reviewed. Pet. App. 10a. In 
addition, those assertions ignore the statutory framework of 
the CSA, which assigns to the Secretary of Health and Hu- 
man Services and the Attorney General the responsibility to 
review any evidence concerning the possible efficacy and 
potential for abuse of controlled substances in order to 
determine, on a uniform nationwide basis, whether they 
may be distributed for medical purposes (if approved by the 

2 Respondents err in asserting (Br. in Opp. 11) that the Ninth Circuit’s 
holding could be supported on the alternative grounds that marijuana 
distribution is required by substantive due process and Ninth and Tenth 
Amendment principles. No court has adopted any of those highly dubious 
contentions, and unless and until a court does so, the decision below has 
the precedential effect of authorizing marijuana distribution in flagrant 
violation of the CSA. There is also no merit to respondents’ attempt (id. 
at 10) to bring themselves within the immunity for state or local “officers” 
of a subdivision of a State “who shall be lawfully engaged in the 
enforcement of any law or municipal ordinance relating to controlled 
substances.” 21 U.S.C. 885(d). Even if we assume, arguendo, that a 
private organization would qualify as a public “officer,” the immunity in 
Section 885(d), which is designed to permit undercover activities and simi- 
lar measures to enforce prohibitions against the distribution of controlled 
substances, obviously does not apply to an entity that is engaged in the 
open and notorious distribution of marijuana with no purpose of enforcing 
any such prohibitions. 

4 

FDA under the Federal Food, Drug, and Cosmetic Act 
(FDCA), 21 U.S.C. 301 et seq., for those purposes). The CSA 
does not delegate that responsibility to individual district 
courts, municipal governments, and private distributors of 
controlled substances throughout the country. 

For the foregoing reasons, there is simply nothing to be 
gained by postponing review of the court of appeals’ decision 
until that court rules on the government’s appeal. To the 
contrary, postponing review would only exacerbate the ad- 
verse consequences of the decision by encouraging broad 
disregard of the CSA and the unregulated distribution of 
marijuana, with the attendant serious potential for abuse 
that Congress sought to prevent by placing marijuana in 
Schedule I under the Act.3 

Respondents argue (Br. in Opp. 10) that the government 
would “suffer[] no inconvenience” from a denial of certiorari 
because this Court, on August 29, 2000, granted our appli- 
cation for a stay of the district court’s July 17, 2000, orders 
on remand. The July 17 orders, however, apply only to re- 
spondents’ distribution of marijuana. The Ninth Circuit’s de- 
cision recognizing a medical necessity defense has pre- 
cedential effect throughout the Ninth Circuit, which has a 
population of more than 50 million people. 

Five States in the Ninth Circuit (Alaska, California, 
Hawaii, Oregon, and Washington) have passed legislation 
sanctioning the use of marijuana for medicinal purposes. 
Pet. 20-21. Within those five States, there already are more 

3 Respondents contend (Br. in Opp. 7) that the government “remains 
free * * * to prosecute anyone that it believes to be violating the federal 
drug laws.” But respondents do not dispute that the court of appeals held 
that “medical necessity” is a “legally cognizable defense” to a criminal 
prosecution under the CSA. Pet. App. 8a. The recognition of a medical 
necessity defense therefore would introduce illegitimate collateral issues 
into drug prosecutions under the Act and would 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. 

5 

than two dozen organizations that are engaged in the 
distribution of marijuana to individuals who claim a need for 
the drug. See Jean Merl, Marijuana Distribution Ban 
Alarms Patients, Los Angeles Times, Aug. 31, 2000, at B1 
(The Supreme Court’s stay “order is unlikely to have much 
immediate effect on the other [24] cannabis clubs around the 
state.”); Martin Kasindorf, Medicinal Pot Use Set Back, 
USA Today, Aug. 30, 2000, at 1A (The Court’s stay “order 
sends a non-binding but chilling message to 35 other clubs 
currently supplying medicinal marijuana to 20,000 Cali- 
fornians.”).4 Thus, unless and until this Court grants review 
and reverses the Ninth Circuit’s legal rulings, the govern- 
ment will be significantly hampered in enforcing the CSA 
against drug traffickers who are acting under the guise of 
“medical necessity.” The Court therefore should grant 
certiorari now so that the matter can be put to rest this 
Term. 

2. Respondents’ defense of the court of appeals’ decision 
is equally without merit. 

a. Respondents argue (Br. in Opp. 17-29) that neither the 
CSA nor its history evinces a clear intent to abrogate a 
common law defense of medical necessity or to divest district 
courts of their equitable discretion to authorize the distribu- 
tion of marijuana to those with asserted medical needs. 
Thus, respondents argue (id. at 26, 28) that, whereas Con- 
gress placed marijuana in Schedule I in order to restrict its 
distribution to the “general public,” a medical necessity de- 

4 See also, e.g. Holly J. Wolcott, Marijuana Club Members Support 
Four Arrested Activists, Los Angeles Times, Aug. 9, 2000, at B6 (dis- 
cussing 800 members in Los Angeles Cannabis Resource Center); Ulysses 
Torassa, City’s Pot Clubs Live On, San Francisco Examiner, June 13, 
1999, at D1 (discussing more than 1000 members in ACT UP San 
Francisco dispensary; more than 300 members in Market Street Club; 
more than 600 members in Patients and Caregivers Health Center; and 
ongoing operations of Cannabis Helping Alleviate Medical Problems 
(CHAMP)). 

6 

fense serves the “different purpose[]” of permitting indivi- 
duals to smoke marijuana when they and their physicians 
“jointly agree” that “generally accepted treatments are 
ineffective.” Those assertions are fundamentally mistaken. 

As we have explained (Pet. 8-16), the recognition of a 
medical necessity defense cannot be reconciled with the text 
and structure of the CSA, or with its overriding purpose to 
protect the public health and safety from the unauthorized 
distribution of controlled substances. The CSA regulates 
marijuana as a “drug.” See 21 U.S.C. 802(6), 812. Absent 
the federal drug laws, there would be no prohibition under 
federal law against the distribution of marijuana for use by 
the general public, including by individuals who want to 
smoke marijuana for a claimed medical purpose. By listing 
marijuana as a Schedule I controlled substance, however, 
Congress has determined that marijuana has a “high po- 
tential 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).5 

Respondents attempt to avoid the plain import of those 
provisions by asserting (Br. in Opp. 6, 21, 25-29) that the 
terms “currently accepted medical use in treatment” and 
“medical necessity” convey different concepts, and that as 

5 Respondents are wrong in contending (Br. in Opp. 18, 19) that 
Congress placed marijuana only “tentatively” in Schedule I because it 
knew that medical experts had not universally concluded that marijuana 
should be banned for all purposes. Absent rescheduling under the Act, 
Congress definitively has placed marijuana in Schedule I, where it has 
been listed for 30 years, knowing full well that it was banning the 
distribution of marijuana for any purpose, including asserted medicinal 
ones, except as authorized by the CSA. See 116 Cong. Rec. 1664 (1970) 
(statement of Sen. Hruska) (noting that marijuana was placed on 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”). 

7 

long as the Ninth Circuit did not authorize respondents to 
distribute marijuana to the general public, the court was 
free to permit them to distribute marijuana to a more limited 
class of persons, i.e., those who claim a medical need to 
smoke marijuana. But it is precisely because Congress has 
determined that marijuana has “no currently accepted medi- 
cal use in treatment” (emphasis added) and placed marijuana 
in Schedule I that Congress has foreclosed a distributor from 
violating the CSA on the ground that the recipients claim a 
“medical necessity” for the drug. 

In particular, respondents have not grasped the central 
point that the CSA imposes an absolute ban on the 
distribution of marijuana—including any distribution for 
asserted medical purposes—outside the strict confines of the 
Act itself. 21 U.S.C. 811-812, 823(f), 841(a)(1). Even for 
drugs listed in Schedules II through V, which Congress and 
the Attorney General have determined do have a “currently 
accepted medical use,” 21 U.S.C. 812(b)(2)-(5), and for which 
the CSA does permit physicians to determine whether parti- 
cular patients have a medical need, 21 U.S.C. 829, the CSA 
imposes strict controls on physicians and pharmacies before 
they may distribute the drug for medical use. See 21 U.S.C. 
821-829; 21 C.F.R. Pts. 1301-1306. That comprehensive set 
of statutory controls leaves no room for the distribution of 
marijuana for medical purposes by relying on a common law 
defense of necessity.6 

6 Respondents erroneously argue (Br. in Opp. 23-26) that, under the 
rule of lenity, Congress may not foreclose a common law defense of 
medical necessity without specifically mentioning that defense in the CSA. 
A necessity defense is unavailable when, as here, it fatally clashes with the 
text, structure, and purpose of the statute, whether or not Congress 
expressly has referred to the defense. United States v. Bailey, 444 U.S. 
394, 415-416 & n.11 (1980) (declining to apply necessity defense in a 
manner that would render a congressional judgment “wholly nugatory”); 
see also Model Penal Code § 3.02(1)(c) (1962) (defense available only where 

8 

The Ninth Circuit’s decision abandons even any pretext of 
compliance with those provisions and instead relegates to 
district courts and juries the power to determine whether 
illicit drugs can be distributed for an asserted medical use. 
The Ninth Circuit’s recognition of a medical necessity 
defense also cannot be reconciled with Congress’s unambigu- 
ous expression in the 1998 legislation, passed in specific 
response to efforts in some States to legalize the use of 
marijuana for medical purposes (see Pet. 11-12), of its con- 
tinued adherence to the rule that the use of marijuana for 
asserted medical purposes not be permitted “without valid 
scientific evidence and the approval of the Food and Drug 
Administration.” Act of Oct. 21, 1998, Pub. L. No. 105-277, 
Div. F, 112 Stat. 2681-2761.7 And the Ninth Circuit’s 
decision likewise cannot be squared with United States v. 
Rutherford, 442 U.S. 544 (1979), in which this Court unani- 
mously rejected the assertion that the safety and effective- 
ness standards of the FDCA had no application to terminally 
ill cancer patients, reasoning 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 the courts to give it effect. 

442 

U.S. at 551. 

b. Respondents contend (Br. in Opp. 13-17) that, under 
this Court’s decisions in Weinberger v. Romero-Barcelo, 
456 U.S. 305 (1982), and Hecht Co. v. Bowles, 321 U.S. 321 

“a legislative purpose to exclude the justification claimed does not 
otherwise plainly appear”); see also Pet. 8-9. 

7 Respondents argue (Br. in Opp. 20) that the 1998 Act “does not have 
the force of law.” Respondents ignore the fact that the CSA (and the 
FDCA) already bar the distribution of marijuana. The 1998 Act expressly 
confirms those preexisting prohibitions specifically with respect to the use 
of marijuana for asserted medical purposes, and it therefore also refutes 
the notion that a court may allow the distribution of marijuana based on 
its own view of the “public interest.” The authorities cited by respondent 
do not cast doubt on the significance of the 1998 Act in those respects. 

9 

(1944), district courts have the equitable discretion to decline 
to enjoin conduct that indisputably violates federal law. 
Neither decision, however, supports that proposition. 

As we have explained (Pet. 17-18), district courts 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 Miller 

v. French, 120 S. Ct. 2246, 2253 (2000); TVA v. Hill, 437 U.S. 
153, 194 (1978). The decisions in Romero-Barcelo and Hecht 
Co. strongly support our position that a court may not exer- 
cise its equitable discretion—which is intended to allow a 
court to decide how best to assure compliance with the 
Act—so as to countenance ongoing violations of the Act. 

In Romero-Barcelo, the Court held that under the Federal 
Water Pollution Control Act, the district court retained dis- 
cretion to order relief, other than an immediate injunction, 
that would “achieve compliance” with the statute. 456 U.S. 
at 307. The district court found that the Navy had com- 
mitted “technical violations” of the statute, without “causing 
any ‘appreciable harm’ to the environment,” by occasionally 
discharging ordnance into waters without a permit. Id. at 
310. The Supreme 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 requiring 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 com- 
pliance 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 defendant 
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 attempting to comply with 
statute, that it had taken “vigorous steps” to correct and 

10 

prevent recurrence of its mistakes, and that issuance of an 
injunction would have “no effect” on ensuring future com- 
pliance. 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 that other remedial 
orders short of an injunction might have been consistent 
with the statute. Id. at 328. The Court made clear, however, 
that courts had 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.” Id. at 331. 

Those decisions stand in stark contrast to the Ninth 
Circuit’s ruling here, which allows the ongoing distribution 
of marijuana in open violation of the CSA. Congress itself 
has weighed what it deemed to be the relevant public- 
interest considerations and made the fundamental policy 
choice that “the 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), and therefore that 
marijuana, a Schedule I controlled substance, may not be 
distributed for any purpose, “[e]xcept as authorized” by the 
Act, 21 U.S.C. 841(a)(1). Accordingly, the Ninth Circuit’s 
extraordinary holding that a court may allow the distri- 
bution of marijuana notwithstanding the CSA is clearly 
contrary to the Act and warrants this Court’s review. 

* * * * * 

For the foregoing reasons and those stated in the petition, 
the petition for a writ of certiorari should be granted. 

Respectfully submitted. 

SETH P. WAXMAN 

Solicitor General 

NOVEMBER 2000