Americans for Safe Access v. Drug Enforcement Administration

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued October 16, 2012 Decided January 22, 2013
No. 11-1265
AMERICANS FOR SAFE ACCESS, ET AL.,
PETITIONERS
v.
DRUG ENFORCEMENT ADMINISTRATION,
RESPONDENT
CARL ERIC OLSEN,
INTERVENOR
On Petition for Review of a Final Order of the
United States Drug Enforcement Administration
Joseph D. Elford argued the cause and filed the briefs for
petitioners.
Carl E. Olsen, pro se, filed briefs for intervenor.
Lena Watkins, Senior Trial Attorney, U.S. Department of
Justice, argued the cause for respondent. With her on the
briefs were Lanny A. Breuer, Assistant Attorney General, and
Anita J. Gay, Senior Trial Attorney.
Before: HENDERSON and GARLAND, Circuit Judges, and
EDWARDS, Senior Circuit Judge.
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Opinion for the Court filed by Senior Circuit Judge
EDWARDS.
Dissenting opinion filed by Circuit Judge HENDERSON.
EDWARDS, Senior Circuit Judge: There is a serious
debate in the United States over the efficacy of marijuana for
medicinal uses. Although marijuana has been legalized in a
number of states, it is classified as a “Schedule I” drug by the
Drug Enforcement Administration (“DEA”), pursuant to its
authority under the Controlled Substances Act of 1970
(“CSA” or “Act”). The DEA has maintained this listing
because it has determined that marijuana “has no currently
accepted medical use in treatment in the United States.” 21
U.S.C. § 812(b)(1)(B). Because Schedule I is the most
restricted drug classification under the CSA, the production,
sale, and use of marijuana are largely banned by federal law.
Petitioners in this case – Americans for Safe Access, the
Coalition to Reschedule Cannabis, Patients Out of Time, and
several individuals – challenge DEA’s denial of its petition to
initiate proceedings to reschedule marijuana.
The CSA permits the DEA to reclassify drugs to less
restrictive schedules according to various statutory criteria,
and interested parties can petition the DEA for such action.
See 21 U.S.C. §§ 811, 812. In October 2002, the Coalition to
Reschedule Cannabis petitioned the DEA to reschedule
marijuana as a Schedule III, IV, or V drug. See Denial of
Petition to Initiate Proceedings to Reschedule Marijuana
(“Denial”), 76 Fed. Reg. 40,552, 40,552 (July 8, 2011). The
DEA denied the petition on July 8, 2011, finding that “[t]here
is no currently accepted medical use for marijuana in the
United States,” and that “[t]he limited existing clinical
evidence is not adequate to warrant rescheduling of marijuana
under the CSA.” Id. at 40,552, 40,567. On July 22, 2011,
3
Petitioners filed a timely petition for review of the DEA
action.
Petitioners claim that “[n]umerous peer-reviewed
scientific studies demonstrate that marijuana is effective in
treating various medical conditions, but the DEA simply
ignores them to conclude that marijuana should remain in
Schedule I.” Pet’rs’ Br. at 20. Petitioners thus contend that the
DEA’s denial of their petition was arbitrary and capricious
and ask this court to remand the case to the agency for further
consideration.
The Government, in turn, argues that we should dismiss
the petition for review on jurisdictional grounds because
Petitioners and Intervenor lack Article III standing. The
Government also asserts that, even if the court determines that
Petitioners or Intervenor have standing, the petition for review
should be denied on the merits. According to the Government,
in the record reviewed by the DEA, “there was no available
evidence of adequate, well-controlled studies demonstrating
marijuana’s safety and effectiveness as a medicine and no
consensus among experts as to these issues. The enactment of
state laws allowing the use of marijuana for medical purposes
did not constitute the required science-based evidence.” Br.
for Resp’t at 23.
We deny the Government’s jurisdictional challenge
because we find that at least one of the named Petitioners,
Michael Krawitz, has standing to challenge the agency’s
action. Krawitz, who is a disabled veteran, is entitled to
medical care through the U.S. Department of Veterans Affairs
(“VA”). Krawitz has suffered injury-in-fact because he must
shoulder a financial cost for services he could otherwise
obtain free of charge from the VA. There is a causal
connection between the DEA’s continuing decision to classify
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marijuana as a Schedule I drug and the VA’s policy of
refusing to provide referrals for state medical marijuana
programs. And a favorable decision from this court would
likely redress Krawitz’s injury because, if the DEA
rescheduled marijuana, the VA could no longer use the CSA
to justify its policy of refusing to complete medical marijuana
referral forms. Krawitz thus satisfies the requirements of
Article III standing. See Lujan v. Defenders of Wildlife, 504
U.S. 555, 560-61 (1992).
On the merits, the question before the court is not
whether marijuana could have some medical benefits. Rather,
the limited question that we address is whether the DEA’s
decision declining to initiate proceedings to reschedule
marijuana under the CSA was arbitrary and capricious. These
questions are not coterminous. “The scope of review under
the ‘arbitrary and capricious’ standard is narrow and a court is
not to substitute its judgment for that of the agency.” Motor
Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto.
Ins. Co., 463 U.S. 29, 43 (1983). On the record before us, we
hold that the DEA’s denial of the rescheduling petition
survives review under the deferential arbitrary and capricious
standard. The petition asks the DEA to reclassify marijuana as
a Schedule III, IV, or V drug, which, under the terms of the
CSA, requires a “currently accepted medical use.” The DEA’s
regulations, which we approved in Alliance for Cannabis
Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define
“currently accepted medical use” to require, inter alia,
“adequate and well-controlled studies proving efficacy.” Id. at
1135. We defer to the agency’s interpretation of these
regulations and find that substantial evidence supports its
determination that such studies do not exist.
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I. Background
A. The Controlled Substances Act
We have previously described marijuana’s listing as a
Schedule I drug under the CSA as follows:
The [CSA] places hazardous drugs in five categories, or
schedules, which impose varying restrictions on access to
the drugs. See 21 U.S.C. § 812 (1988). Marijuana is
assigned by statute to Schedule I, the most restrictive of
these. Schedule I drugs may be obtained and used
lawfully only by doctors who submit a detailed research
protocol for approval by the Food and Drug
Administration and who agree to abide by strict
recordkeeping and storage rules.
The CSA allows the Attorney General to reschedule a
drug if he finds that it does not meet the criteria for the
schedule to which it has been assigned. 21 U.S.C.
§ 811(a). The Attorney General has delegated this
authority to the [DEA] Administrator. In rescheduling a
drug, the Administrator must consider, inter alia,
“[s]cientific evidence of [the drug’s] pharmacological
effect, if known,” and “[t]he state of current scientific
knowledge regarding the drug or other substance.” 21
U.S.C. § 811(c)(2), (3).
A drug is placed in Schedule I if (1) it “has a high
potential for abuse,” (2) it has “no currently accepted
medical use in treatment in the United States,” and (3)
“[t]here is a lack of accepted safety for use of the
drug . . . under medical supervision.” 21 U.S.C.
§ 812(b)(1) (1988) (emphasis added).
Alliance for Cannabis Therapeutics, 15 F.3d at 1133.
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A criterion for Schedule III, IV, and V drugs is the
existence of “a currently accepted medical use in treatment in
the United States.” 21 U.S.C. § 812(b)(3)-(5). To assess
whether there is a “currently accepted medical use,” the DEA
looks for five necessary elements: “(1) The drug’s chemistry
must be known and reproducible; (2) There must be adequate
safety studies; (3) There must be adequate and well-controlled
studies proving efficacy; (4) The drug must be accepted by
qualified experts; and (5) The scientific evidence must be
widely available.” See Denial, 76 Fed. Reg. at 40,579. Unlike
Schedule I drugs, federal law permits individuals to obtain
Schedule II, III, IV, or V drugs for personal medical use with
a valid prescription. See 21 U.S.C. § 829(a)-(c).
Under the CSA, “any interested party” may petition the
DEA to reschedule a drug. 21 U.S.C. § 811(a). In reaching a
final scheduling decision, the DEA must request from the
Department of Health & Human Services (“DHHS”) a
“scientific and medical evaluation,” as well as a
recommendation for the drug’s appropriate schedule. 21
U.S.C. § 811(b). These recommendations are binding on the
DEA insofar as they rest on scientific and medical
determinations. Id.B. Procedural History
As noted above, Petitioners in this case include three
advocacy organizations and several individuals. On
September 1, 2011, Carl Olsen intervened on behalf of
Petitioners. He asserts a religious interest in the use of
marijuana.
On October 9, 2002, the Coalition to Reschedule
Cannabis petitioned the DEA to reschedule marijuana as a
Schedule III, IV, or V drug. See Petition to Reschedule
Cannabis (Marijuana), reprinted in Joint Appendix (“J.A.”)
7
46-162. Petitioners assert that marijuana’s Schedule I status is
inappropriate because, inter alia, it “has an accepted medical
use in the United States.” The petition to reschedule supported
this assertion with citations to alleged peer-reviewed,
published studies on the potential medical applications of
marijuana. See, e.g., id. at 38-56, reprinted in J.A. 86-104.
The DEA submitted Petitioner’s rescheduling request to
DHHS. Denial, 76 Fed. Reg. at 40,552.
In its scientific and medical evaluation, DHHS concluded
that marijuana lacks a currently accepted medical use in the
United States. In reaching this conclusion, DHHS applied the
DEA’s established five-prong test, which requires a known
and reproducible drug chemistry, adequate safety studies,
adequate and well-controlled studies demonstrating efficacy,
acceptance of the drug by qualified experts, and widely
available scientific evidence. See id. at 40,559-60. DHHS
stated that there are approximately 483 known components of
the cannabis plant. Id. at 40,554. The components include 66
compounds called cannabinoids, and marijuana is the only
plant in which these compounds are known to exist. Id.
DHHS stated, however, that marijuana’s chemistry was not
“known and reproducible” as there had not been “a complete
scientific analysis” of its components. Id. at 40,552, 40,560.
In addition, although there was ongoing research, there were
no studies of sufficient quality to assess “the efficacy and full
safety profile of marijuana for any medical condition.” Id. at
40,560. Further, there was “a material conflict of opinion
among experts” as to medical safety and efficacy, thereby
precluding a finding that qualified experts accepted marijuana
as a medicine. Id. Additionally, the raw research data
typically were not available in a format that would allow
“adequate scientific scrutiny of whether the data demonstrate
safety or efficacy.” Id.
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DHHS gave the DEA its evaluation and scheduling
recommendation on December 6, 2006. See id. at 40,552-66.
The DEA subsequently denied the petition to reschedule on
July 8, 2011, finding that “[t]he limited existing clinical
evidence is not adequate to warrant rescheduling of marijuana
under the CSA.” Id. at 40,567.
On July 22, 2011, Petitioners filed a timely petition for
review of the DEA’s decision. Petitioners argue that the DEA
acted arbitrarily and capriciously when it concluded that
marijuana lacks a “currently accepted medical use” and has a
“high potential for abuse.” They ask this court to remand the
case to the DEA for reconsideration of its decision. The
Government contests these assertions and responds further
that Petitioners, for various reasons, lack standing to
challenge the DEA’s determination in court.
After oral argument, “mindful of our independent
obligation to be sure of our jurisdiction,” we requested
supplemental filings on Petitioners’ standing. Sierra Club v.
EPA, 292 F.3d 895, 898 (D.C. Cir. 2002); see also Am.
Library Ass’n v. FCC, 401 F.3d 489, 492, 496 (D.C. Cir.
2005) (requesting supplemental filings on standing where the
parties reasonably believed that the initial filings had
sufficiently addressed the issue).
II. Analysis
A. Standing
“To satisfy the requirements of Article III standing in a
case challenging government action, a party must allege an
injury in fact that is fairly traceable to the challenged
government action, and ‘it must be likely, as opposed to
merely speculative, that the injury will be redressed by a
favorable decision.’” Nat’l Wrestling Coaches Ass’n v. U.S.
9
Dep’t of Educ., 366 F.3d 930, 937 (D.C. Cir. 2004) (quoting
Defenders of Wildlife, 504 U.S. at 560-61). Petitioners have
advanced several theories of standing in this case for each of
the various parties. However, to proceed to the merits of their
claims, we need only find one party with standing. See Tozzi
v. U.S. Dep’t of Health and Human Servs., 271 F.3d 301, 310
(D.C. Cir. 2001) (declining to address standing of remaining
appellants after finding one appellant with standing). Because
we conclude that petitioner Michael Krawitz has individual
standing, we need not address the issue for the other
Petitioners.
1. Petitioners’ Burden of Production
Before seeking review in this court, Petitioners were
under no obligation to establish Article III standing. See
Pfizer Inc. v. Shalala, 182 F.3d 975, 980 (D.C. Cir. 1999)
(“An administrative agency, which is not subject to Article III
of the Constitution of the United States and related prudential
limitations, may issue a declaratory order in mere anticipation
of a controversy or simply to resolve an uncertainty.”).
However, when a federal court of appeals reviews an agency
action, Article III standing must be demonstrated “as it would
be if such review were conducted in the first instance by the
district court.” Sierra Club, 292 F.3d at 899.
A “petitioner’s burden of production in the court of
appeals is accordingly the same as that of a plaintiff moving
for summary judgment in the district court: it must support
each element of its claim to standing ‘by affidavit or other
evidence.’” Id. (quoting Defenders of Wildlife, 504 U.S. at
561). “Its burden of proof is to show a ‘substantial
probability’ that it has been injured, that the defendant caused
its injury, and that the court could redress that injury.” Id.(quoting Am. Petroleum Inst. v. EPA, 216 F.3d 50, 63 (D.C.
10
Cir. 2000)). “In assessing [Petitioners’] standing, we must
assume they will prevail on the merits of their claims.” NB ex
rel. Peacock v. District of Columbia, 682 F.3d 77, 82 (D.C.
Cir. 2012).
If the parties reasonably, but mistakenly, believed that the
initial filings before the court had sufficiently demonstrated
standing, the court may – as it did here, see Order, Oct. 16,
2012 – request supplemental affidavits and briefing to
determine whether the parties have met the requirements for
standing. See, e.g., Pub. Citizen, Inc. v. Nat’l Highway Traffic
Safety Admin., 489 F.3d 1279, 1296-97 (D.C. Cir. 2007)
(noting that it was “prudent” for the court to seek
supplemental submissions where there was a question about
standing); Am. Library Ass’n, 401 F.3d at 492, 496.
Petitioners submitted supplemental filings on October 25,
2012, offering factual information in support of Krawitz’s
standing. See generally Supp. Krawitz Aff; Pet’rs’ Supp. Br.
The Government was afforded an opportunity to respond to
Petitioners’ supplemental filing and did so on November 1,
2012.
The dissenting opinion argues that we should decline to
consider Petitioners’ supplemental filings because they
allegedly rest on a new theory of standing and, thus, violate
the commands of Circuit Rule 28(a)(7) and, relatedly, Sierra
Club and its progeny. We disagree.
Circuit Rule 28(a)(7) states:
In cases involving direct review in this court of
administrative actions, the brief of the appellant or
petitioner must set forth the basis for the claim of
standing. . . . When the appellant’s or petitioner's
standing is not apparent from the administrative record,
11
the brief must include arguments and evidence
establishing the claim of standing.
D.C. CIR. R. 28(a)(7). In this case, Petitioners obviously made
a serious effort to satisfy the requirements of the rule by
setting forth their evidence and arguments in support of
standing in their opening brief to the court. See Pet’rs’ Br. at
5-7. In addition, Circuit Rule 28(a)(7) does not itself impose
any jurisdictional requirements. So even assuming, arguendo,
that Petitioners failed to adhere to the briefing requirements of
the rule – which has not been shown in this case – this would
not compel sua sponte dismissal by the court.
Because the briefing requirements of Circuit Rule
28(a)(7) are not jurisdictional, they have no relevance here
unless the Government raised a viable objection pursuant to
the rule. The Government raised no such objection to
Petitioners’ opening brief to the court. Likewise, in its
response to Petitioners’ supplemental filings, the Government
did not contend that Petitioners had infringed Circuit Rule
28(a)(7) or Sierra Club and its progeny. Rather, the
Government merely noted that Petitioners’ supplemental
filings stated, “for the first time, that [Krawitz] participates in
the ‘Oregon Medical Marijuana Program.’” Supp. Br. for
Resp’t at 1. The Government did not “protest that Krawitz
raised a new standing theory,” as the dissenting opinion
argues. Nor did the Government claim that Petitioners’
supplemental submissions on standing should not be
addressed by the court because they failed to satisfy the
requirements of Circuit Rule 28(a)(7) or the controlling law of
the circuit. Indeed, the Government did not even suggest that
it was disadvantaged in the adversarial process because of the
nature of Petitioners’ supplemental filings. See Sierra Club,
292 F.3d at 901. The Government’s arguments in response to
Petitioners’ supplemental filings focused on its claim that
12
Petitioners had failed to demonstrate Krawitz’s Article III
standing.
Although Petitioners made a reasonable effort to satisfy
the command of Circuit Rule 28(a)(7) in their opening brief
by advancing evidence and arguments in support of standing,
the court still had questions regarding whether the facts
asserted by Petitioners were sufficient to satisfy the
requirements of Article III standing. Therefore, the panel
majority, adhering to well-established circuit law, requested
supplemental briefing after oral arguments. Nothing in the
text of the rule bars the court from requesting such filings.
As Judge Kavanaugh noted in Public Citizen, Inc. v. National
Highway Traffic Safety Administration:
This Court “retains the discretion to seek supplemental
submissions from the parties if it decides that more
information is necessary to determine whether petitioners,
in fact, have standing.” Am. Library Ass’n v. FCC, 401
F.3d 489, 494 (D.C. Cir. 2005); see, e.g., Am. Chemistry
Council v. Dep’t of Transp., 468 F.3d 810, 815 (D.C. Cir.
2006) (“[W]e raised the issue of standing at oral argument
and requested supplemental briefing.”); Action on
Smoking & Health v. Dep’t of Labor, 100 F.3d 991, 992
(D.C. Cir. 1996) (petitioner “furnished post-argument
affidavits at our request”); see also Abigail Alliance for
Better Access to Developmental Drugs v. Von
Eschenbach, 469 F.3d 129, 132 (D.C. Cir. 2006)
(supplemental briefing sought where agency first
challenged standing after panel opinion issued).
489 F.3d at 1296.
The point here is simple: under the law of this circuit, the
members of a panel retain discretion to seek supplemental
13
submissions on standing to fulfill the obligation of the court to
determine whether the requirements of Article III have been
met. Circuit Rule 28(a)(7) does not preclude this, nor does the
law of the circuit. The reason is clear. Circuit Rule 28(a)(7)
says only that “[w]hen the appellant’s or petitioner’s standing
is not apparent from the administrative record, the brief must
include arguments and evidence establishing the claim of
standing.” D.C. CIR. R. 28(a)(7). This language is hardly free
from ambiguity because what may be “apparent from the
administrative record” to one reasonable person may seem
less clear to another. And some parties may be unsure
whether to explore every conceivable avenue of standing in
the first instance in light of the admonition in Sierra Club
cautioning advocates to submit only “a concise recitation of
the basis [for standing].” 292 F.3d at 901 (emphasis added);
see also Am. Library Ass’n, 401 F.3d at 494 (noting that a
“gotcha” construction of Circuit Rule 28(a)(7) and Sierra
Club “is inconsistent with our precedent and would have the
undesirable effect of causing parties to include long
jurisdictional statements in practically all opening briefs for
fear that the court might find their standing less than self-
evident”). So it is hardly surprising that it sometimes happens,
as it did in this case, that a party advances plausible
arguments and offers concrete evidence in support of standing
in its opening brief, reasonably assuming that nothing more is
necessary, and the members of the panel still have questions.
In such circumstances, as our case law shows, the court acts
with prudence in applying Circuit Rule 28(a)(7) and in
determining whether supplemental submissions are necessary.
That is what was done in this case.
2. The Elements of Standing in this Case
Petitioners’ strongest theory of standing is that Krawitz,
a veteran of the United States Air Force, is harmed by the
14
DEA’s continued classification of marijuana as a Schedule I
drug because it deprives him of services that he is entitled to
receive free of charge from the VA. The record indicates that,
as a condition of his pain management treatment, Krawitz was
asked by VA officials to sign a “Contract for Controlled
Substance Prescription” that would prohibit him from, inter
alia, using medical marijuana. See Supp. Krawitz Aff. ¶ 7; see
also Krawitz Aff. Ex.1. Krawitz claims that, because he
refused to sign this contract, he is now required to seek pain
treatment outside the VA system. See Supp. Krawitz Aff. ¶¶
8-10. Petitioners also contend that Krawitz suffers injury
because a separate VA policy forces him to pay for a non-VA
physician in Oregon to obtain the referral forms required to
participate in that state’s medical marijuana program. See id.
¶¶ 11-15. Petitioners argue that both of these injuries are
caused by the DEA’s continued decision to classify marijuana
as a Schedule I drug and would be redressed by a favorable
decision from this court. In response, the Government argues
that Petitioners cannot prove redressability because their
conclusion that rescheduling will result in any relief from the
VA is too speculative.
The first element of the “irreducible constitutional
minimum of standing” is injury in fact, meaning “an invasion
of a legally protected interest which is (a) concrete and
particularized, and (b) actual or imminent, not conjectural or
hypothetical.” Defenders of Wildlife, 504 U.S. at 560(citations omitted) (internal quotation marks omitted).
Petitioners clearly establish injury in fact here and
Respondents do not seriously question it. As a veteran,
Krawitz is entitled to free medical care from the VA system.
This care normally includes the “[c]ompletion of forms . . . by
healthcare professionals based on an examination or
knowledge of the veteran’s condition.” 38 C.F.R.
§ 17.38(a)(1)(xv) (2012). This policy is implemented by VHA
15
Directive 2008-071, which states that “clinicians must honor
all requests by patients for completion of non-VHA medical
forms.” Supp. Krawitz Aff. Ex. 2. However, pursuant to VHA
Directive 2011-004: “It is VHA policy to prohibit VA
providers from completing forms seeking recommendations
or opinions regarding a Veteran’s participation in a State
marijuana program.” Supp. Krawitz Aff. Ex. 1. Thus, to
participate in Oregon’s medical marijuana program, Krawitz
consults with a non-VA physician in Oregon at an annual cost
of approximately $140.00. See Supp. Krawitz Aff. ¶ 15. In
being forced to pay out-of-pocket for care that he could
otherwise receive freely from the VA system, Krawitz clearly
suffers an “actual” and “concrete” injury to his “legally
protected interest.” Defenders of Wildlife, 504 U.S. at 560; cf.
Peacock, 682 F.3d at 83 (holding that “procedural violations
that threaten an individual’s ability to obtain Medicaid
coverage of prescription medications” constitute injury in
fact).
Beyond injury in fact, we must determine whether
Krawitz’s injuries have been caused by the DEA’s decision to
continue listing marijuana as a Schedule I drug and whether
there is a “substantial probability” that the relief requested
would redress the injury. See Nat’l Wrestling Coaches Ass’n,
366 F.3d at 944. The modest complexity of these questions
arises from the fact that the agency action challenged by
Petitioners – i.e. the DEA’s continued classification of
marijuana as a Schedule I drug – is not the direct cause of
Krawitz’s injury. Rather, his injury is caused by the actions of
the VA system, which has decided as a matter of policy not to
assist patients in obtaining substances illegal under federal
law. This court has addressed standing under analogous
circumstances in at least four previous decisions. In those
cases, we looked for whether “the record presented substantial
evidence of a causal relationship between the government
16
policy and the third-party conduct, leaving little doubt as to
causation and the likelihood of redress.” Id. at 941. In two of
those decisions, we found standing. In the other two, we
denied standing. This case more strongly resembles the
former two.
In Block v. Meese, 793 F.2d 1303, 1308 (D.C. Cir. 1986),
the plaintiff’s company owned exclusive distribution rights to
a film that the Justice Department classified as “political
propaganda.” The plaintiff alleged injury to his economic
interests because the classification deterred potential
customers. Id. To support this assertion, the plaintiff
submitted declarations and affidavits from potential customers
who were dissuaded from purchasing the film because of its
status as “propaganda.” Id. We held that there was sufficient
factual evidence on the record to establish that the harm was
“attributable to the classification.” Id.In Tozzi v. U.S. Department of Health and Human
Services, 271 F.3d 301 (D.C. Cir. 2001), a manufacturer of
PVC plastic challenged a decision by the Secretary of Health
and Human Services to list dioxin, a chemical released
through the incineration of PVC plastic, as a “known”
carcinogen. Though this triggered no new federal regulation,
the manufacturer sued on the theory that the classification had
prompted state and local entities to regulate to the detriment
of the manufacturer. Id. at 309. Looking carefully at the
record, we found several reasons to conclude that the
government action was “at least a substantial factor
motivating the third parties’ actions.” Id. at 308. We noted
that Congress intended the Secretary’s determination “to
serve as the federal government’s authoritative statement on
the current state of knowledge regarding the carcinogenicity
of various chemicals.” Id. at 309 (citing H.R. REP. NO. 95-
1192, at 28 (1978) (describing the Secretary’s list as a
17
“comprehensive document” containing “all known or
suspected carcinogenic agents”)). We also noted that the
Secretary’s list of carcinogens “is widely disseminated and
highly influential,” and we pointed to several local
government restrictions on the use of PVC plastic that
explicitly cited the Secretary’s determination that dioxin is a
“known” carcinogen. Id. We also found it significant that the
term “carcinogen” is “inherently pejorative and damaging,”
noting that this increased the probability of an economically
harmful third party response. Id.In at least two other cases, we have denied standing when
a non-party’s conduct was the most direct cause of the alleged
injury. In National Wrestling Coaches Ass’n, 366 F.3d at 933,
“several membership organizations that represent[ed] the
interests of collegiate men’s wrestling coaches, athletes, and
alumni” challenged the government’s Title IX enforcement
policy, alleging that it had caused several schools to cancel
their men’s wrestling programs. We denied standing,
reasoning that the plaintiffs “offer[ed] nothing but speculation
to substantiate their claim that a favorable decision from this
court [would] redress their injuries by altering these schools’
independent decisions.” Id. at 937. And in Renal Physicians
Ass’n v. U.S. Department of Health & Human Services, 489
F.3d 1267 (D.C. Cir. 2007), a medical association challenged
a government regulation that allegedly depressed their
compensation for in-house patient referrals. Once again, this
court denied standing, concluding it was “speculative,” not
“likely,” that rescinding the regulation would increase the rate
of compensation. Id. at 1277.
Turning to the facts of this case, the causation element is
satisfied because Krawitz’s injury is fairly traceable to the
Government’s decision to continue listing marijuana as a
Schedule I drug. As with the statute in Tozzi, Congress made
18
clear when it passed the CSA that the agency’s scheduling
decisions should serve as the federal government’s
“authoritative statement” on the legitimacy of particular
narcotics and dangerous drugs. 271 F.3d at 309. The House
Report for the CSA explains that Congress had already
enacted “more than 50 pieces of legislation” relating to the
regulation of dangerous drugs. H.R. REP. NO. 91-1444,
reprinted in 1970 U.S.C.C.A.N. 4566, 4571. Congress
intended the CSA and its scheduling program to “collect[] and
conform[] these diverse laws in one piece of legislation.” Id.Furthermore, the Government’s classification of marijuana
under Schedule I is “inherently pejorative.” Tozzi, 271 F.3d at
309. Under the terms of the Act, a Schedule I drug “has a high
potential for abuse,” “has no currently accepted medical use,”
and has “a lack of accepted safety for use.” 21 U.S.C.
§ 812(b)(1). When the DEA classified marijuana as a
Schedule I drug, pursuant to its delegated authority under the
CSA, it announced an authoritative value judgment that surely
was meant to affect the policies of third-party federal
agencies.
Unsurprisingly, the VA has heeded the DEA’s judgment
regarding marijuana, thus making the question of causation
relatively easy in this case. The record before the court clearly
shows that the VA’s refusal to complete Krawitz’s medical
marijuana forms is traceable to the DEA’s continued decision
to classify marijuana as Schedule I. VHA Directive 2011-004,
which prohibits VA providers from completing state medical
marijuana forms, cites three times to marijuana’s Schedule I
status. See Supp. Krawitz Aff. Ex. 1. Indeed, compliance with
the CSA is the only justification the Directive cites for this
policy. See id. (“[VA] providers must comply with all Federal
laws, including the Controlled Substances Act. Marijuana is
classified as a Schedule I drug under the Controlled
Substances Act.”). In light of this evidence, the Government,
19
in its brief to the court, offers nothing more than a perfunctory
challenge to causation. This case is nothing like the situations
in National Wrestling and Renal Physicians, where the
records contained only weak evidence of causal links between
the claimants’ injuries and the contested actions of third-party
defendants.
The Government focuses most on redressability in
contesting Krawitz’s standing in this case. The Government
argues that rescheduling marijuana would not “generate a
significant increase in the likelihood” that the VA would
authorize its physicians to recommend marijuana in Oregon.
See Town of Barnstable v. FAA, 659 F.3d 28, 32 (D.C. Cir.
2011). In support of this argument, the Government suggests
that, based on the current scientific evidence, there would be
no approval by the Food & Drug Administration of medical
marijuana, and, absent such approval, VA physicians would
be unlikely to recommend a substance that could not be
prescribed or readily subjected to supervised use.
The Government’s argument against redressability fails.
The issue is not whether VA physicians would recommend
marijuana usage to patients. The issue is only whether
rescheduling marijuana would “generate a significant increase
in the likelihood” that Krawitz could obtain completed state
medical marijuana forms from the VA. See id. Under existing
regulations and VHA Directive 2008-071, VA clinicians are
subject to a non-discretionary duty to “honor all requests by
patients for completion of non-VHA medical forms.” See 38
C.F.R. § 17.38(a)(1)(xv) (2012); Supp. Krawitz Aff. Ex. 2.
The only thing stopping VA clinicians from performing this
duty with respect to Krawitz’s request is VHA Directive
2011-004. See Supp. Krawitz Aff. Ex. 1. The only reason the
VA cites for implementing VHA Directive 2011-004 is the
classification of marijuana as a Schedule I drug. Id. Therefore,
20
were marijuana rescheduled to reflect its potential for medical
use, the VA would have no expressed reason to retain VHA
Directive 2011-004 and VA clinicians would likely be subject
to a non-discretionary duty to complete Krawitz’s state
medical marijuana forms.
This case is fully distinguishable from National Wrestling
and Renal Physicians, where we found redressability lacking.
In both those cases, in addition to a tenuous showing of
causation, there were reasons beyond the challenged
government action for the third parties to continue the
conduct that caused injury to the plaintiffs. In National
Wrestling there were many factors that led each school to
cancel its men’s wrestling program, such as “the absence of
league sponsorship for wrestling, budgetary concerns, and the
need to balance the athletic program with other University
priorities.” 366 F.3d at 942. Furthermore, Title IX and its
accompanying regulations would have remained in force
regardless of the case’s outcome. See id. at 943. Indeed the
plaintiffs in National Wrestling did not even contest the
legality of the Title IX regulations. Id. In Renal Physicians the
court found that the plaintiffs had failed to demonstrate
redressability in part because, even if the challenged
regulation were struck down, market forces might drive the
injurious conduct to continue. See 489 F.3d at 1277.
In contrast, this case is more like Tozzi. There we found it
significant for redressability that the Secretary’s listing of
dioxin as a “known” carcinogen was the only such
pronouncement by the federal government. See 271 F.3d at
309-10. Therefore, if we had set aside that listing, “dioxin
activists could no longer point to an authoritative
determination by the United States government that dioxin is
‘known’ to cause cancer in humans. . . . State and local
governments would be less likely to regulate dioxin, and
21
healthcare companies would in turn be less likely to stop
using PVC plastic.” Id. at 310. Here, the Schedule I listing is
the authoritative federal declaration of marijuana’s illegality
and unfitness for medical use. The VA is a federal agency and
thus surely inclined to subscribe to such a federal declaration.
Were the substance rescheduled, the VA would lose the only
express justification for its policy against completing state
medical marijuana forms. Therefore, it is “likely” instead of
merely “speculative” that Krawitz’s injury would be
redressed.
Because Krawitz has Article III standing due to his
inability to have the VA system complete his state medical
marijuana forms, we need not consider whether his alleged
inability to obtain pain management services from the VA in
Virginia warrants standing. We also need not consider
whether the other Petitioners have standing as well. See Watt
v. Energy Action Educ. Found., 454 U.S. 151, 160 (1981)
(“Because we find [one plaintiff] has standing, we do not
consider the standing of the other plaintiffs.”); see also Tozzi,
271 F.3d at 310 (same).
B. The DEA’s Denial of the Petition to Initiate
Proceedings to Reschedule Marijuana
On the merits, Petitioners claim that the DEA’s final
order denying their request to initiate proceedings to
reschedule marijuana was arbitrary and capricious. Under the
terms of the CSA, marijuana cannot be rescheduled to
Schedules III, IV, or V without a “currently accepted medical
use.” 21 U.S.C. § 812(b)(3)-(5). To assess whether marijuana
has such a medical use, the agency applies a five-part test:
“(1) The drug’s chemistry must be known and reproducible;
(2) There must be adequate safety studies; (3) There must be
adequate and well-controlled studies proving efficacy; (4) The
22
drug must be accepted by qualified experts; and (5) The
scientific evidence must be widely available.” See Denial, 76
Fed. Reg. 40,552, 40,579. The DEA’s five-part test was
expressly approved by this court in Alliance for Cannabis
Therapeutics, 15 F.3d at 1135. Because the agency’s factual
findings in this case are supported by substantial evidence and
because those factual findings reasonably support the
agency’s final decision not to reschedule marijuana, we must
uphold the agency action.
Under the Administrative Procedure Act, a court may set
aside an agency’s final decision only if it is “arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law.” 5 U.S.C. § 706(2)(A). “We will not
disturb the decision of an agency that has ‘examine[d] the
relevant data and articulate[d] a satisfactory explanation for
its action including a rational connection between the facts
found and the choice made.’” MD Pharm. Inc. v. DEA, 133
F.3d 8, 16 (D.C. Cir. 1998) (quoting Motor Vehicle Mfrs.
Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43
(1983)). Furthermore, the agency’s interpretation of its own
regulations “must be given controlling weight unless it is
plainly erroneous or inconsistent with the regulation.” Thomas
Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994). The
CSA also directs this court to review the agency’s findings of
fact for substantial evidence. See 21 U.S.C. § 877. Under this
standard, we must “ask whether a reasonable mind might
accept a particular evidentiary record as adequate to support a
conclusion.” Dickinson v. Zurko, 527 U.S. 150, 162 (1999).
Petitioners do not seriously dispute the propriety of the
five-part test approved in Alliance for Cannabis Therapeutics.
Thus, they are left with the difficult task of showing that the
DEA has misapplied its own regulations. Petitioners challenge
the agency’s reasoning on each of the five factors. However,
23
“[a] drug will be deemed to have a currently accepted medical
use for CSA purposes only if all five of the foregoing
elements are demonstrated.” Denial, 76 Fed. Reg. at 40,579.
In this case, we need only look at one factor, the existence of
“adequate and well-controlled studies proving efficacy,” to
resolve Petitioners’ claim.
In its scientific and medical evaluation, DHHS concluded
that “research on the medical use of marijuana ha[d] not
progressed to the point that marijuana [could] be considered
to have a ‘currently accepted medical use’ or a ‘currently
accepted medical use with severe restrictions.’” Id. at 40,560.
As noted above, DHHS’ recommendations are binding on the
DEA insofar as they rest on scientific and medical
determinations. 21 U.S.C. § 811(b). After an exhaustive
examination of the issue, the DEA, adhering to DHHS’
recommendation, reached the following conclusion:
To establish accepted medical use, the effectiveness of a
drug must be established in well-controlled, well-
designed, well-conducted, and well-documented
scientific studies, including studies performed in a large
number of patients (57 FR 10499, 1992). To date, such
studies have not been performed. The small clinical trial
studies with limited patients and short duration are not
sufficient to establish medical utility. Studies of longer
duration are needed to fully characterize the drug’s
efficacy and safety profile. Scientific reliability must be
established in multiple clinical studies. Furthermore,
anecdotal reports and isolated case reports are not
adequate evidence to support an accepted medical use of
marijuana (57 FR 10499, 1992). The evidence from
clinical research and reviews of earlier clinical research
does not meet this standard.
24
Denial, 76 Fed. Reg. at 40,579.
Petitioners contest these findings, arguing that their
petition to reschedule marijuana cites more than two hundred
peer-reviewed published studies demonstrating marijuana’s
efficacy for various medical uses, and that those studies were
largely ignored by the agency. As we explain below,
Petitioners’ singular reliance on “peer-reviewed” studies
misses the mark. It is also noteworthy that Petitioners’ brief to
this court fails to convincingly highlight any significant
studies allegedly ignored by DHHS or the DEA.
Petitioners’ argument focuses at length on one study – the
March 1999 report from the Institute of Medicine (“IOM”) –
that was clearly addressed by the DEA. The IOM report does
indeed suggest that marijuana might have medical benefits.
See, e.g., INST. OF MEDICINE, MARIJUANA AND MEDICINE:
ASSESSING THE SCIENCE BASE 177 (Janet E. Joy et al. eds.,
1999), reprinted in J.A. 208 (“For patients such as those with
AIDS or who are undergoing chemotherapy, and who suffer
simultaneously from severe pain, nausea, and appetite loss,
cannabinoid drugs might offer broad-spectrum relief not
found in any other single medication.”). However, the DEA
fairly construed this report as calling for “more and better
studies to determine potential medical applications of
marijuana” and not as sufficient proof of medical efficacy
itself. Denial, 76 Fed. Reg. at 40,580. In other words, “while
the IOM report did support further research into therapeutic
uses of cannabinoids, the IOM report did not ‘recognize
marijuana’s accepted medical use’ but rather the potential
therapeutic utility of cannabinoids.” Id.
At bottom, the parties’ dispute in this case turns on the
agency’s interpretation of its own regulations. Petitioners
construe “adequate and well-controlled studies” to mean peer-
25
reviewed, published studies suggesting marijuana’s medical
efficacy. The DEA, in contrast, interprets that factor to require
something more scientifically rigorous. In explaining its
conclusion that there is a lack of clinical evidence establishing
marijuana’s “currently accepted medical use,” the agency said
the following:
[A] limited number of Phase I investigations have been
conducted as approved by the FDA. Clinical trials,
however, generally proceed in three phases. See 21
C.F.R. 312.21 (2010). Phase I trials encompass initial
testing in human subjects, generally involving 20 to 80
patients. Id. They are designed primarily to assess initial
safety, tolerability, pharmacokinetics, pharmaco-
dynamics, and preliminary studies of potential
therapeutic benefit. (62 FR 66113, 1997). Phase II and
Phase III studies involve successively larger groups of
patients: usually no more than several hundred subjects
in Phase II and usually from several hundred to several
thousand in Phase III. 21 C.F.R. 312.21. These studies
are designed primarily to explore (Phase II) and to
demonstrate or confirm (Phase III) therapeutic efficacy
and benefit in patients. (62 FR 66113, 1997). No Phase II
or Phase III studies of marijuana have been conducted.
Even in 2001, DHHS acknowledged that there is
“suggestive evidence that marijuana may have beneficial
therapeutic effects in relieving spasticity associated with
multiple sclerosis, as an analgesic, as an antiemetic, as an
appetite stimulant and as a bronchodilator.” (66 FR
20038, 2001). But there is still no data from adequate and
well-controlled clinical trials that meets the requisite
standard to warrant rescheduling.
Id. at 40,579-80.
26
The DEA interprets “adequate and well-controlled
studies” to mean studies similar to what the Food and Drug
Administration (“FDA”) requires for a New Drug Application
(“NDA”). See id. at 40,562. DHHS found that “there have
been no NDA-quality studies that have scientifically assessed
the efficacy of marijuana for any medical condition.” Id. It is
well understood that, under FDA protocols, “adequate and
well-controlled investigations” require “clinical
investigations, by experts qualified by scientific training and
experience to evaluate the effectiveness of the drug involved,
on the basis of which it could fairly and responsibly be
concluded by such experts that the drug will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or
proposed labeling thereof.” 21 U.S.C. § 355(d). This is a
rigorous standard. See, e.g., Edison Pharm. Co. v. FDA, 600
F.2d 831, 843 (D.C. Cir. 1979) (holding that substantial
evidence supported the FDA’s conclusion that double-blind
testing of a new drug was necessary before the drug could be
administered to cardiac patients); Holland-Rantos Co. v. U.S.
Dep’t of Health, Educ. and Welfare, 587 F.2d 1173, 1174
(D.C. Cir. 1978) (refusing to construe the requirement of a
“well-controlled investigation” in a “self-defeating fashion”).
Contrary to what Petitioners suggest, something more
than “peer-reviewed” studies is required to satisfy DEA’s
standard, and for good reason. “[S]cientists understand that
peer review per se provides only a minimal assurance of
quality, and that the public conception of peer review as a
stamp of authentication is far from the truth.” Charles
Jennings, Quality and Value: The True Purpose of Peer
Review, NATURE.COM (2006), http://www.nature.com/nature/
peerreview/debate/nature05032.html; see also Lynn S.
McCarty et al., Information Quality in Regulatory Decision
Making: Peer Review versus Good Laboratory Practice, 120
27
ENVTL. HEALTH PERSP. 927, 930 (2012) (“It is difficult to
extract from the extensive body of work and commentary
published over the last 25-30 years that scientific journal peer
review is a coherent, consistent, reliable, evaluative
procedure. . . . [T]he opposite conclusion may be more
accurate.”). Petitioners may have cited some peer–reviewed
articles in support of their position, but they have not pointed
to “adequate and well-controlled studies” confirming the
efficacy of marijuana for medicinal uses. If, as is the case
here, “there is substantial evidence to support the [agency’s]
finding that the[] studies [offered by petitioner] are not
helpful, then petitioner must fail.” Unimed, Inc. v.
Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In making
this assessment, we must “remind ourselves that our role in
the Congressional scheme is not to give an independent
judgment of our own, but rather to determine whether the
expert agency entrusted with regulatory responsibility has
taken an irrational or arbitrary view of the evidence
assembled before it.” Id.The DEA’s construction of its regulation is eminently
reasonable. Therefore, we are obliged to defer to the agency’s
interpretation of “adequate and well-controlled studies.” See
Thomas Jefferson Univ., 512 U.S. at 512 (deferring to “an
agency’s interpretation of its own regulations”). Judged
against the DEA’s standard, we find nothing in the record that
could move us to conclude that the agency failed to prove by
substantial evidence that such studies confirming marijuana’s
medical efficacy do not exist.
Finally, Petitioners suggested during oral argument that
the Government had foreclosed the research that would be
necessary to create sufficiently reliable clinical studies of
marijuana’s medical efficacy. Because Petitioners did not
properly raise this issue with the DEA and there is nothing in
28
the record to support it, we do not consider it here. We note,
however, that DHHS’ recommendation explained that “[t]he
opportunity for scientists to conduct clinical research with
marijuana exists under the [D]HHS policy supporting clinical
research with botanical marijuana.” Denial, 76 Fed. Reg. at
40,562. Thus, it appears that adequate and well-controlled
studies are wanting not because they have been foreclosed but
because they have not been completed.
III. Conclusion
For the reasons discussed above, we hereby deny the
petition for review.
KAREN LECRAFT HENDERSON, Circuit Judge, dissenting:
Over a decade ago, our court was compelled to remind all
petitioners of first principles, namely, they must assure us that
they meet Article III’s case or controversy requirement if their
standing is not “self-evident” from the record. Sierra Club v.
EPA, 292 F.3d 895, 900 (D.C. Cir. 2002). We subsequently
transformed the holding into D.C. Circuit Rule 28(a)(7) to tell
the litigating world we really meant what we said in Sierra
Club. Since then, our precedent and our Rule seem to have
been honored more in the breach than in compliance. We
have issued pre-argument orders alerting the parties to be
prepared to address standing at oral argument because of our
uncertainty regarding standing based on the briefing. See, e.g.,
Order, Cherry v. FCC, No. 10-1151 (Feb. 23, 2012). We have
allowed a second—late—opportunity to establish standing at
the reply brief stage. See Exxon Mobil Corp. v. FERC, 571
F.3d 1208, 1219 (D.C. Cir. 2008). We have even asked for
post-argument briefs based on the petitioner’s failure
theretofore to establish standing. See Pub. Citizen, Inc. v.
Nat’l Highway Traffic Safety Admin., 489 F.3d 1279, 1297
(D.C. Cir. 2007); see also id. at 462-63 (Sentelle, J.,
dissenting). Some of us have been more forgiving than others.
See, e.g., Am. Library Ass’n v. FCC, 401 F.3d 489, 492 (D.C.
Cir. 2005) (Edwards, J.) (articulating Sierra Club exception if
petitioners “reasonably [but mistakenly] believed their
standing [was] self-evident”); Communities Against Runway
Expansion, Inc. v. FAA, 355 F.3d 678, 685 (D.C. Cir. 2004)
(Edwards, J.) (excusing belated submissions attached to reply
brief because they made standing “patently obvious”); KERM,
Inc. v. FCC, 353 F.3d 57, 60-61 (D.C. Cir. 2004) (noting
petitioner’s belated assertion of standing but nonetheless
analyzing standing arguments) (Edwards, J.). Perhaps it is too
late to blow the whistle but I do not share the solicitude my
colleagues show the petitioners—no novices on their merits
2
claim1—here, especially in view of the fact that their standing
theory for the lone petitioner with standing is, post-argument,
brand new.
Petitioners Americans for Safe Access (ASA), Coalition
for Rescheduling Cannabis (CRC), Patients Out of Time
(POT), Kathy Jordan, Michael Krawitz, Richard Steeb and
William Britt (petitioners) petition for review of the decision
of the Drug Enforcement Administration (DEA or Agency),
Denial of Petition To Initiate Proceedings To Reschedule
Marijuana, 76 Fed. Reg. 40,552 (Jul. 8, 2011), denying their
petition to initiate rulemaking proceedings to reschedule
marijuana as a Schedule I substance under the Controlled
Substances Act (CSA), 21 U.S.C. §§ 801 et seq. The majority
determines—based on his post-argument submission—that
Krawitz has standing and thus proceeds to the merits. I
believe the post-argument submission should not have been
allowed. Once allowed, it should not have been considered
because it asserts a new theory of standing. The remaining
petitioners also lack standing and therefore the petition for
review should have been dismissed.
I.
To press their claim, the petitioners must establish that at
least one of them has standing. Rumsfeld v. Forum for
Academic & Inst. Rights, Inc., 547 U.S. 47, 52 n.2 (2006).
Article III standing has three elements: “(1) injury-in-fact, (2)
causation, and (3) redressability.” Sierra Club, 292 F.3d at1
Two individuals who joined the petitioners’ quest to reschedule
marijuana at the administrative stage—Jon Gettman and High
Times—had petitioned for review of DEA’s earlier failure to
reschedule marijuana. We dismissed their petition for lack of
standing. Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002).
3
898. Reviewing administrative action, we require that the
petitioner “either identify in that record evidence sufficient to
support its standing to seek review or, if there is none because
standing was not an issue before the agency, submit additional
evidence to the court of appeals.” Id. at 899. Three of the
seven petitioners—ASA, CRC and POT—are organizations.
The remaining petitioners—Jordan, Krawitz, Steeb and
Britt—are members of ASA (ASA Members). Neither CRC
nor POT has attempted to establish its standing. The
remaining petitioners assert three theories of standing: ASA’s
standing as an association, the individual standing of the four
ASA Members and ASA’s standing representing its members.
I begin with Krawitz’s standing as he is the one whose
standing the majority affirms.
II.
A. Krawitz’s Standing
In their opening brief, the petitioners did not distinguish
Krawitz from the other ASA Members. With that brief, the
petitioners submitted an affidavit executed by Krawitz.
Krawitz declared therein that he was a disabled veteran and
that he used marijuana to alleviate his pain. Krawitz explained
that he received medical benefits from the United States
Department of Veterans Affairs (VA) but that
[b]ecause of my medical cannabis use, I am currently
being denied my prescription pain treatment by the
VA based upon their illegal drug policy that routinely,
administratively, denies pain treatment as punishment
for using cannabis by veterans that do not live in a
state with legal medical cannabis, based on VA’s
policy regarding medical cannabis, which, among
other things, prohibits VA physicians from discussing
therapeutic uses of cannabis with me. A true and
4
correct copy of that policy is attached hereto as
Exhibit 1. Although the bulk of my medical care still
occurs at VA hospital I am now seeing an outside
M.D. for my pain treatment under the VA’s fee basis
program.
Krawitz Aff. ¶ 4 (bracketed text omitted) (emphasis added).
To his affidavit, Krawitz attached a document entitled
“CONTRACT FOR CONTROLLED SUBSTANCE
PRESCRIPTION.” Krawitz Aff. Ex. 1 at 1. The document is
confusing at best, and, at worst, makes it appear as if the VA
itself could be providing Krawitz with marijuana. See, e.g.,
Krawitz Aff. Ex. 1 at 1 (“I will not request or accept
controlled substance medication from any other physician or
individual while I am receiving such medication from my
physician at the Salem VAMC Clinic.”). The petitioners,
unhelpfully, provided no explanation of the contract in either
their opening or their reply briefs.
Krawitz’s affidavit and exhibit failed to establish
standing. His affidavit boiled down to the averment that he
was injured because the VA had a drug policy that “denies
pain treatment as punishment for using cannabis by veterans
that do not live in a state with legal medical cannabis,”
Krawitz Aff. ¶ 4 (emphasis added). But Krawitz challenges
federal, not state law, and he has provided no evidence or
argument that rescheduling marijuana under the CSA will
change the way any state regulates marijuana. Indeed, state
marijuana legislation in recent years has distinctly diverged
from federal law. See, e.g., Gettman v. DEA, 290 F.3d 430,
435 (D.C. Cir. 2002) (“[S]peculative claims dependent upon
the actions of third parties do not create standing.”).
Notwithstanding the failure of the petitioners’ showing
regarding standing—specifically, Krawitz’s affidavit with
5
attachment—we issued a post-argument order, giving them
yet another opportunity2 to “clarify and amplify the assertions
made in paragraph 4 of the Affidavit of Michael Krawitz
regarding his individual standing.” I dissented from the order
because our precedent unequivocally directs the method by
which a petitioner must establish standing, a method the
petitioners ignored. In 2002, we explained:
Henceforth, therefore, a petitioner whose standing is
not self-evident should establish its standing by the
submission of its arguments and any affidavits or
other evidence appurtenant thereto at the first
appropriate point in the review proceeding. In some
cases that will be in response to a motion to dismiss
for want of standing; in cases in which no such
motion has been made, it will be with the petitioner’s
opening brief—and not, as in this case, in reply to the
brief of the respondent agency. In either procedural
context the petitioner may carry its burden of
production by citing any record evidence relevant to
its claim of standing and, if necessary, appending to
its filing additional affidavits or other evidence
sufficient to support its claim. In its opening brief, the
petitioner should also include in the “Jurisdictional
Statement” a concise recitation of the basis upon
which it claims standing.
. . . . [A]ll too often the petitioner does not submit
evidence of those facts with its opening brief and the
2
The petitioners’ reply brief, while providing a more detailed
standing argument and including (improperly) a supplemental
affidavit, was nonetheless deficient. With their post-argument
opportunity to supplement, the petitioners have now been allowed
three chances to establish standing.
6
respondent is therefore left to flail at the unknown in
an attempt to prove the negative, or the court raises its
own question about the petitioner’s standing and ends
up having to direct the parties to file supplemental
briefs in order to ensure that the issue is joined in a
fair and thorough adversarial process.
Sierra Club, 292 F.3d at 900-01 (emphasis added). We
cautioned that “[a]bsent good cause shown . . . a litigant
should not expect the court” to depart from the above
procedure. Id. at 900. Sierra Club does not make the
petitioner’s showing optional—it instead constitutes binding
Circuit law. As noted earlier, we codified Sierra Club in our
Circuit Rules as follows:
In cases involving direct review in this court of
administrative actions, the brief of the appellant or
petitioner must set forth the basis for the claim of
standing. This section, entitled “Standing,” must
follow the summary of argument and immediately
precede the argument. When the appellant’s or
petitioner’s standing is not apparent from the
administrative record, the brief must include
arguments and evidence establishing the claim of
standing. See Sierra Club v. EPA, 292 F.3d 895, 900-
01 (D.C. Cir. 2002). If the evidence is lengthy, and
not contained in the administrative record, it may be
presented in a separate addendum to the brief.
D.C. Cir. R. 28(a)(7); see also Int’l Bhd. of Teamsters v.
Transp. Sec. Admin., 429 F.3d 1130, 1134-35 & n.2 (D.C. Cir.
2005) (dismissing petition for review because petitioner “first
addressed its standing at oral argument, in response to
questioning by the court”); Exxon Mobil, 571 F.3d at 1220
(declining to consider standing theory first articulated at oral
7
argument). The petitioners had made no effort to show “good
cause”3 for their initial failure to establish standing. And, this
being so, I opposed giving them yet another opportunity to
establish standing.
In response to the order, the petitioners filed a
supplemental brief with a new Krawitz affidavit, featuring a
new theory of standing. He avers, for the first time, that he
spends one or two months per year in Oregon, where he
obtains marijuana for medical use. To obtain medicinal
marijuana in Oregon, a person must apply for a registration
card, which requires him to submit annually “[v]alid, written
documentation from the person’s attending physician stating
that the person has been diagnosed with a debilitating medical
condition and that the medical use of marijuana may mitigate
the symptoms or effects of the person’s debilitating medical
condition.” See Or. Rev. Stat § 475.309(2), (7)(C)(i). Krawitz
complains that the VA has a policy—VHA Directive 2011-
004—prohibiting its physicians from providing such
documentation, thus forcing him to pay $140.00 per year to
consult an Oregon physician who can so provide.
Unlike his original affidavit—in which Krawitz declared
that the VA denied him pain treatment—Krawitz’s new
affidavit states that the VA is not denying him treatment for
pain based on his marijuana use. Moreover, VHA Directive
2011-004 makes plain that the VA does not have a policy of
denying pain treatment to veterans who are using marijuana,
instead declaring: “VHA policy does not administratively
3
We have found “good cause” if, for example, a petitioner had a
reasonable belief its standing was self-evident, see Am. Library
Ass’n, 401 F.3d at 492 or if supplemental declarations submitted
with a reply brief made standing “patently obvious,” see
Communities Against Runway Expansion, 355 F.3d at 685.
8
prohibit Veterans who participate in State marijuana programs
from also participating in VHA . . . pain control programs . . .
[D]ecisions to modify treatment plans in those situations need
to be made by individual providers in partnership with their
patients.” VHA Directive 2011-004 (Jan. 31, 2011), available
at http://www.va.gov/VHAPUBLICATIONS/View
Publication.asp?pub_ID=2362.
In other words, Krawitz asserts a new injury-in-fact—a
$140.00 per year pocketbook injury—that is nowhere to be
found in even the most generous reading of his original
affidavit. As we have earlier held, however, “we are aware of
no authority which permits a party to assert an entirely new
injury (and thus, an entirely new theory of standing) in its
reply brief.” Coal. for Responsible Regulation, Inc. v. EPA,
684 F.3d 102, 147 (D.C. Cir. 2012) (per curiam) (emphasis
added). And plainly—until today—we have never permitted a
petitioner to assert an entirely new injury and theory of
standing in a post-argument submission.4
4
Oregon’s policy—not that of the VA or of DEA—is the direct
cause of Krawitz’s annual $140.00 injury because, if Oregon
eliminated the physician documentation requirement, Krawitz’s
injury would be immediately redressed. By contrast, if we ordered
DEA to reschedule marijuana, the VA might rescind VHA
Directive 2011-004 and Krawitz’s VA physician might complete
the Oregon documentation for Krawitz. See Memorandum
Regarding State Medical Marijuana Registration Forms from
Department of Veterans Affairs General Counsel to Under
Secretary of Health at 5 (May 21, 2008) (cited by VHA Directive
2011-004) (stating, prior to promulgation of VHA Directive 2011-
004, “[a]t present, the language of 38 C.F.R. § 17.38(c)(3) does not
require the completion of [medical marijuana] forms by VHA
physicians [because t]his regulatory provision eliminates non-FDA
9
Because my colleagues found that Krawitz has standing,
they proceeded directly to the merits. Rumsfeld, 547 U.S. at52 n.2 (“[T]he presence of one party with standing is
sufficient to satisfy Article III's case-or-controversy
requirement.”). Because I believe Krawitz lacks standing, I
must consider the other petitioners’ standing.
B. Other Petitioners’ Standing
ASA’s Organizational Standing
In their opening brief, the petitioners asserted that ASA
has standing as an organization because it must expend
“significant resources combatting the DEA’s positions
respecting marijuana’s medical use and abuse potential, which
would be redressed by a favorable decision.” Pet’rs’ Opening
Br. 6. In their reply brief, they argue “ASA has been unable to
employ a full-time California Director to interface with
government agencies in California and those of other medical
marijuana states to implement state law, in particular, the
regulation of medical marijuana dispensaries.” Pet’rs’ Reply
Br. 3 (citing Sherer Supp. Aff. ¶ 2).
An organization does not have standing based on a mere
“ ‘setback to [its] abstract social interests.’ ” Nat’l Ass’n of
Home Builders v. EPA, 667 F.3d 6, 11 (D.C. Cir. 2011)
(quoting Nat’l Taxpayers Union, Inc. v. United States, 68 F.3d
1428, 1433 (D.C. Cir. 1995)). An association’s “self-serving
observation that it has expended resources to educate its
members and others regarding [a challenged statutory
provision] does not present an injury in fact,” particularly if
“[t]here is no evidence that [the challenged provision] has
approved drugs from the basic care provided to veterans”); see also
VHA Directive 2011-004, supra.
10
subjected [the association] to operational costs beyond those
normally expended to review, challenge, and educate the
public.” Nat’l Taxpayers Union, 68 F.3d at 1434. Nor is
standing found “when the only ‘injury’ arises from the effect
of the regulations on the organizations’ lobbying activities.”
Ctr. for Law & Educ. v. Dep’t of Educ., 396 F.3d 1152, 1161
(D.C. Cir. 2005).
The petitioners support ASA’s organizational standing by
relying on Havens Realty Corp. v. Coleman, 455 U.S. 363(1982). In Havens, a nonprofit corporation sued the owner of
an apartment complex for damages under the Fair Housing
Act because “the [discriminatory] practices of [the apartment
complex] had frustrated the organization’s counseling and
referral services, with a consequent drain on resources.” Id. at
369. The Supreme Court upheld the nonprofit’s standing
because the “practices have perceptibly impaired [its] ability
to provide counseling and referral services for low-and
moderate-income homeseekers . . . . Such concrete and
demonstrable injury to the organization’s activities—with the
consequent drain on the organization’s resources—constitutes
far more than simply a setback to the organization’s abstract
social interests.” Id. at 379.
We considered a similar standing issue in Spann v.
Colonial Vill., Inc., 899 F.2d 24 (D.C. Cir. 1990), where we
found two organizations had standing to assert a claim for
injunctive relief and damages under the Fair Housing Act
because the discriminatory conduct “required [plaintiffs] to
devote more time, effort, and money to endeavors designed to
educate not only black home buyers and renters, but the D.C.
area real estate industry and the public that racial preference
in housing is indeed illegal.” Id. at 27; see also id. at 28-29(“increased education and counseling could plausibly
required”). We emphasized “the difference between this suit
11
and one presenting only abstract concerns or complaints about
government policy;” specifically, the plaintiffs “do not seek to
compel government action, [or] to involve the courts in a
matter that could be resolved in the political branches” but
rather “are private actors suing other private actors, traditional
grist for the judicial mill.” Id. at 30.
Unlike Havens and Spann, this case does not involve
“private actors suing other private actors, traditional grist for
the judicial mill.” Id. Nor does it involve a suit for damages
under a federal statute (like the Fair Housing Act) that creates
a cause of action. Instead, it serves “to compel government
action, [and] to involve the courts in a matter that could be
resolved in the political branches.”5 Id. Moreover, ASA’s
asserted injury—that it must spend money to “educate the
public about the true benefits of marijuana” and to “lobby[ ]
local, state and federal governments,” Sherer Aff. ¶¶ 8, 12—is
essentially an argument that ASA cannot allocate issue
advocacy expenses in the way it would prefer, which is
insufficient to establish standing. See Ctr. for Law & Educ.,
396 F.3d at 1162 (“The only ‘service’ impaired is pure issue-
advocacy—the very type of activity distinguished by
Havens.”). Nor have the petitioners explained how ASA
would be able to avoid these expenditures if marijuana were
rescheduled. For example, ASA would still need to meet the
substantial scientific evidence—identified by DEA—that
rejects its position regarding marijuana’s medical efficacy.
Similarly, ASA would need to counter statements made by
5
ASA and similar organizations have had great political success in
recent years. See, e.g., Louise Radnofsky, Voters Weigh Social
Issues, Wall St. J., Nov. 7, 2012 (seventeen states and District of
Columbia have legalized the medicinal use of marijuana;
Washington and Colorado have legalized marijuana for recreational
use).
12
entities other than DEA (including the very state and local
governments they are lobbying) that oppose legalization of
marijuana for medical use. See Nat’l Taxpayers Union, 68
F.3d at 1434 (“There is no evidence that [the challenged
statutory provision] has subjected [the association] to
operational costs beyond those normally expended to review,
challenge, and educate the public.”).
The closest the petitioners come to establishing an injury
to ASA as an organization is their statement that “[s]ince
2006, due to expenditures made by ASA to offset the false
statements made by the [DEA and HHS] that marijuana has
no medical use and is extremely dangerous, ASA has been
unable to hire a full-time California Director.” Sherer Supp.
Aff ¶ 2. But whatever happened in 2006 that prevented ASA
from hiring a full-time California Director, it could not have
been marijuana’s Schedule I listing because marijuana has
been so listed since 1970. See 21 U.S.C. § 812(c)
(establishing initial schedules of controlled substances).
ASA Members’ Individual Standing
The petitioners also assert that the three ASA Members
other than Krawitz have their own individual standing. In
their opening brief, they assert that if marijuana were removed
from Schedule I, the three would no longer be “deterred from
cultivating their own medicine . . . since they would likely be
afforded a medical necessity defense in federal court.” Pet’rs’
Opening Br. 7. Nevertheless, “speculative claims dependent
upon the actions of third parties do not create standing.”
Gettman, 290 F.3d at 434-35 (dismissing petition—for lack of
standing—of marijuana researcher who argued DEA decision
not to reschedule marijuana decreased his potential customers
and diminished his ability to conduct research). Here, the
causal chain is even more speculative. ASA’s Members allege
13
that their injury could be redressed by a favorable ruling
because (1) if marijuana were rescheduled; and (2) if they
chose to cultivate marijuana; and (3) if the federal
government detected the cultivation; and (4) if the federal
government prosecuted the cultivators; and (5) if the
cultivators asserted a medical necessity defense; and (6) if the
court accepted the medical necessity defense; then (7) they
would avoid criminal liability for cultivation.6
Moreover, the existence of a medical necessity defense
for marijuana cultivation is tenuous at best. The petitioners
assert that marijuana’s Schedule I status is the only thing
preventing courts from recognizing the defense, citing United
States v. Oakland Cannabis Buyers’ Coop., 532 U.S. 483(2001), which held that no medical necessity defense exists
for the illegal distribution of various controlled substances,
including marijuana, because the CSA “reflects a
determination that marijuana has no medical benefits worthy
of an exception.” Id. at 491. The Court’s reasoning made
6
The ASA Members’ standing argument is reminiscent of the
nursery rhyme “For Want of a Nail:”
For want of a nail, the shoe was lost,
For want of the shoe, the horse was lost,
For want of the horse, the rider was lost,
For want of the rider, the battle was lost,
For want of the battle, the kingdom was lost,
And all for the want of a horse-shoe nail!
Stuart Minor Benjamin, Proactive Legislation and the First
Amendment, 99 MICH. L. REV. 281, 329 n.168 (2000) (quoting
Mother Goose’s Nursery Rhymes 191 (Walter Jerrold ed., Alfred
A. Knopf Inc. 1993) (1903)). While a lost nail may lead to a lost
kingdom, establishing Article III standing requires more than a
good imagination.
14
clear, however, that rescheduling marijuana would not
necessarily produce a medical necessity defense because “it is
an open question whether federal courts ever have authority to
recognize a necessity defense not provided by statute.” Id. at
490 (“Even at common law, the defense of necessity was
somewhat controversial.”).
Assuming arguendo the three ASA Members decide to
cultivate marijuana, it is far from likely that a federal
prosecutor would exercise his discretion to prosecute. In fact,
the Department of Justice recently suggested that it did not
consider it an efficient use of resources to prosecute
“individuals with cancer or other serious illnesses who use
marijuana as part of a recommended treatment regimen
consistent with applicable law, or those caregivers in clear
and unambiguous compliance with existing state law who
provide such individuals with marijuana.” David W. Ogden,
Deputy Attorney General, U.S. Dep’t of Justice,
Investigations and Prosecutions in States Authorizing the
Medical Use of Marijuana (Oct 19, 2009), available at
http://www.justice.gov/opa/documents/medical-
marijuana.pdf.7
7
But see James M. Cole, Deputy Attorney General, U.S. Dep’t of
Justice, Guidance Regarding the Ogden Memo in Jurisdictions
Seeking to Authorize Marijuana for Medical Use (June 29, 2011),
available at http://www.azdhs.gov/medicalmarijuana/documents
/resources/guidance_regarding_medical_marijuana.pdf (Ogden
Memorandum was not intended to shield from prosecution
“planned facilities” with “revenue projections of millions of
dollars” and that “[p]ersons who are in the business of cultivating,
selling or distributing marijuana . . . are in violation of the
Controlled Substances Act, regardless of state law”).
15
ASA’s Representational Standing
Finally, I believe that ASA lacks standing to bring this
action on behalf of its members because ASA has failed to
establish that one of its members has standing to sue in his
own right. Fund Democracy, LLC v. SEC, 278 F.3d 21, 25
(D.C. Cir. 2002) (“An association only has standing to bring
suit on behalf of its members when[, inter alia,] its members
would otherwise have standing to sue in their own right . . .
.”).8
Because I believe that no petitioner possesses Article III
standing, I respectfully dissent.9
8
In addition, intervenor Carl Olsen lacks standing. He concedes
that his injury can be redressed only if marijuana is removed from
all CSA schedules, a remedy the petitioners do not seek.
Furthermore, Olsen makes distinct arguments from those of the
petitioners—for example, he invokes “federalism”—and thus he
cannot supply the requisite standing. See Ill. Bell Tel. Co. v. FCC,
911 F.2d 776, 786 (D.C. Cir. 1990).
9
While my dissent begins with the observation that some of my
colleagues are more forgiving than others in allowing exceptions to
the Sierra Club rule, codified in Rule 28(a)(7), it is now apparent
the majority would have the exceptions swallow the Rule. Ignoring
our longstanding precedent that arguments may not be made for the
first time in a reply brief, see, e.g., Porter v. Shah, 606 F.3d 809,
814 n.3 (D.C. Cir. 2010), during oral argument, see, e.g., United
States v. Southerland, 486 F.3d 1355, 1360 (D.C. Cir. 2007), or
during rebuttal oral argument, see, e.g., Coal. of Battery Recyclers
Ass’n v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010)—they would
revise Rule 28(a)(7) to create a “reasonable belief/effort” mega-
exception permitting any party to assert an entirely new standing
16
theory not only in a reply brief or during oral argument but even
after oral argument.
The elephant in the room is that we do not allow “a party to assert
an entirely new injury (and thus, an entirely new theory of standing)
in its reply brief,” Coal. for Responsible Regulation, 684 F.3d at
147, much less in a supplemental brief. As already noted, in his
supplemental affidavit Krawitz raises a new injury and, thus, a new
theory of standing. Yet in response to this undisputed fact, my
colleagues do not attempt to claim Krawitz’s theory of standing is
not new. Instead, they skirt the issue by noting that DEA did not so
argue in its supplemental brief. First and foremost, whether a party
has established standing is for the court—not the parties—to
decide. See, e.g., Animal Legal Defense Fund, Inc. v. Espy, 29 F.3d
720, 723 n.2 (D.C. Cir. 1994) (“Standing . . . is a jurisdictional
issue which cannot be waived or conceded.”); cf. Am. Library
Ass’n, 401 F.3d at 495 (“[W]hether standing is self-evident must be
judged from the perspective of the court[.]”). And the majority’s
statement that Rule 28(a)(7) (let alone Sierra Club) “ha[s] no
relevance” absent an objection, see Maj. Op. 11, is wholly
unsupported. In any event, DEA did protest that Krawitz raised a
new standing theory. While DEA did not cite Sierra Club or Rule
28(a)(7), it maintained that Krawitz “states, for the first time, that
he participates in the ‘Oregon Medical Marijuana Program;’ ” and
now “claims not that he is denied VA pain treatment in Oregon but
that the VA prohibits its physicians from completing a state
program form.” Resp’t Supp. Br. 1.
The majority’s new exception declares that “[i]f the parties
reasonably, but mistakenly, believed that the initial filings before
the court had sufficiently demonstrated standing, the court may—as
it did here—request supplemental affidavits and briefing.” Maj. Op.
10 (citing Pub. Citizen, Inc., 489 F.3d at 1296-97; Am. Library
Ass’n, 401 F.3d at 492, 496); see also Maj. Op. 12 (suggesting we
should allow supplemental briefing if parties make a “reasonable
effort” to satisfy Rule 28(a)(7)). But Public Citizen and American
17
Library Association establish no such exception to our Rule. See,
e.g., Am. Library Ass’n, 401 F.3d at 492 (establishing exception if
the petitioners “reasonably [but mistakenly] believed their standing
[was] self-evident”). Moreover, I do not see how the majority’s new
exception would not apply in virtually every case—presumably
parties do not make “unreasonable” standing arguments or fail to
use reasonable efforts to establish their standing.