Americans for Safe Access v. DEA

7/29/2019 Americans for Safe Access v. DEA

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United States Court of AppealsFOR 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. Elfordargued the cause and filed the briefs forpetitioners.

Carl E. Olsen, pro se, filed briefs for intervenor.

Lena Watkins, Senior Trial Attorney, U.S. Department ofJustice, argued the cause for respondent. With her on thebriefs wereLanny A. Breuer, Assistant Attorney General, andAnita J. Gay, Senior Trial Attorney.

Before: HENDERSON and GARLAND, Circuit Judges, andEDWARDS, Senior Circuit Judge.


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Opinion for the Court filed by Senior Circuit JudgeEDWARDS.

Dissenting opinion filed by Circuit Judge HENDERSON.

EDWARDS, Senior Circuit Judge: There is a seriousdebate in the United States over the efficacy of marijuana formedicinal uses. Although marijuana has been legalized in anumber of states, it is classified as a Schedule I drug by theDrug Enforcement Administration (DEA), pursuant to its

authority under the Controlled Substances Act of 1970(CSA or Act). The DEA has maintained this listingbecause it has determined that marijuana has no currentlyaccepted medical use in treatment in the United States. 21U.S.C. 812(b)(1)(B). Because Schedule I is the mostrestricted 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, theCoalition to Reschedule Cannabis, Patients Out of Time, andseveral individualschallenge DEAs denial of its petition toinitiate proceedings to reschedule marijuana.

The CSA permits the DEA to reclassify drugs to lessrestrictive 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 toReschedule Cannabis petitioned the DEA to reschedulemarijuana as a Schedule III, IV, or V drug. See Denial ofPetition to Initiate Proceedings to Reschedule Marijuana(Denial), 76 Fed. Reg. 40,552, 40,552 (July 8, 2011). TheDEA denied the petition on July 8, 2011, finding that [t]hereis no currently accepted medical use for marijuana in the

United States, and that [t]he limited existing clinicalevidence is not adequate to warrant rescheduling of marijuanaunder the CSA.Id. at 40,552, 40,567. On July 22, 2011,


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Petitioners filed a timely petition for review of the DEAaction.

Petitioners claim that [n]umerous peer-reviewedscientific studies demonstrate that marijuana is effective intreating various medical conditions, but the DEA simplyignores them to conclude that marijuana should remain inSchedule I. Petrs Br. at 20. Petitioners thus contend that theDEAs denial of their petition was arbitrary and capriciousand ask this court to remand the case to the agency for further

consideration.

The Government, in turn, argues that we should dismissthe petition for review on jurisdictional grounds becausePetitioners and Intervenor lack Article III standing. TheGovernment also asserts that, even if the court determines thatPetitioners or Intervenor have standing, the petition for reviewshould be denied on the merits. According to the Government,in the record reviewed by the DEA, there was no availableevidence of adequate, well-controlled studies demonstratingmarijuanas safety and effectiveness as a medicine and no

consensus among experts as to these issues. The enactment ofstate laws allowing the use of marijuana for medical purposesdid not constitute the required science-based evidence. Br.for Respt at 23.

We deny the Governments jurisdictional challengebecause we find that at least one of the named Petitioners,Michael Krawitz, has standing to challenge the agencysaction. Krawitz, who is a disabled veteran, is entitled tomedical 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 otherwiseobtain free of charge from the VA. There is a causalconnection between the DEAs continuing decision to classify


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marijuana as a Schedule I drug and the VAs policy ofrefusing to provide referrals for state medical marijuanaprograms. And a favorable decision from this court wouldlikely redress Krawitzs injury because, if the DEArescheduled marijuana, the VA could no longer use the CSAto justify its policy of refusing to complete medical marijuanareferral forms. Krawitz thus satisfies the requirements ofArticle III standing. SeeLujan v. Defenders of Wildlife, 504U.S. 555, 560-61 (1992).

On the merits, the question before the court is notwhether marijuana could have some medical benefits. Rather,the limited question that we address is whether the DEAsdecision declining to initiate proceedings to reschedulemarijuana under the CSA was arbitrary and capricious. Thesequestions are not coterminous. The scope of review underthe arbitrary and capricious standard is narrow and a court isnot to substitute its judgment for that of the agency.MotorVehicle Mfrs. Assn of the U.S., Inc. v. State Farm Mut. Auto.Ins. Co., 463 U.S. 29, 43 (1983). On the record before us, wehold that the DEAs denial of the rescheduling petition

survives review under the deferential arbitrary and capriciousstandard. The petition asks the DEA to reclassify marijuana asa Schedule III, IV, or V drug, which, under the terms of theCSA, requires a currently accepted medical use. The DEAsregulations, which we approved in Alliance for CannabisTherapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), definecurrently accepted medical use to require, inter alia,adequate and well-controlled studies proving efficacy.Id. at1135. We defer to the agencys interpretation of theseregulations and find that substantial evidence supports itsdetermination that such studies do not exist.


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I. Background

A. The Controlled Substances Act

We have previously described marijuanas listing as aSchedule I drug under the CSA as follows:

The [CSA] places hazardous drugs in five categories, orschedules, which impose varying restrictions on access tothe drugs. See 21 U.S.C. 812 (1988). Marijuana is

assigned by statute to Schedule I, the most restrictive ofthese. Schedule I drugs may be obtained and usedlawfully only by doctors who submit a detailed researchprotocol for approval by the Food and DrugAdministration and who agree to abide by strictrecordkeeping and storage rules.

The CSA allows the Attorney General to reschedule adrug if he finds that it does not meet the criteria for theschedule 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 adrug, the Administrator must consider, inter alia,[s]cientific evidence of [the drugs] pharmacologicaleffect, if known, and [t]he state of current scientificknowledge regarding the drug or other substance. 21U.S.C. 811(c)(2), (3).

A drug is placed in Schedule I if (1) it has a highpotential for abuse, (2) it has no currently acceptedmedical 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 theexistence ofa currently accepted medical use in treatment inthe United States. 21 U.S.C. 812(b)(3)-(5). To assesswhether there is a currently accepted medical use, the DEAlooks for five necessary elements: (1) The drugs chemistrymust be known and reproducible; (2) There must be adequatesafety studies; (3) There must be adequate and well-controlledstudies proving efficacy; (4) The drug must be accepted byqualified experts; and (5) The scientific evidence must bewidely available.See Denial, 76 Fed. Reg. at 40,579. UnlikeSchedule I drugs, federal law permits individuals to obtainSchedule II, III, IV, or V drugs for personal medical use witha valid prescription. See 21 U.S.C. 829(a)-(c).

Under the CSA, any interested party may petition theDEA to reschedule a drug. 21 U.S.C. 811(a). In reaching afinal scheduling decision, the DEA must request from theDepartment of Health & Human Services (DHHS) ascientific and medical evaluation, as well as arecommendation for the drugs appropriate schedule. 21U.S.C. 811(b). These recommendations are binding on the

DEA insofar as they rest on scientific and medicaldeterminations.Id.

B. Procedural History

As noted above, Petitioners in this case include threeadvocacy organizations and several individuals. OnSeptember 1, 2011, Carl Olsen intervened on behalf ofPetitioners. He asserts a religious interest in the use ofmarijuana.

On October 9, 2002, the Coalition to RescheduleCannabis petitioned the DEA to reschedule marijuana as aSchedule III, IV, or V drug. See Petition to RescheduleCannabis (Marijuana), reprinted in Joint Appendix (J.A.)


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46-162. Petitioners assert that marijuanas Schedule I status isinappropriate because, inter alia, it has an accepted medicaluse in the United States. The petition to reschedule supportedthis assertion with citations to alleged peer-reviewed,published studies on the potential medical applications ofmarijuana. See, e.g., id. at 38-56, reprinted in J.A. 86-104.The DEA submitted Petitioners rescheduling request toDHHS.Denial, 76 Fed. Reg. at 40,552.

In its scientific and medical evaluation, DHHS concluded

that marijuana lacks a currently accepted medical use in theUnited States. In reaching this conclusion, DHHS applied theDEAs established five-prong test, which requires a knownand reproducible drug chemistry, adequate safety studies,adequate and well-controlled studies demonstrating efficacy,acceptance of the drug by qualified experts, and widelyavailable scientific evidence. See id. at 40,559-60. DHHSstated that there are approximately 483 known components ofthe cannabis plant. Id. at 40,554. The components include 66compounds called cannabinoids, and marijuana is the onlyplant in which these compounds are known to exist. Id.

DHHS stated, however, that marijuanas chemistry was notknown and reproducible as there had not been a completescientific analysis of its components. Id. at 40,552, 40,560.In addition, although there was ongoing research, there wereno studies of sufficient quality to assess the efficacy and fullsafety profile of marijuana for any medical condition.Id. at40,560. Further, there was a material conflict of opinionamong experts as to medical safety and efficacy, therebyprecluding a finding that qualified experts accepted marijuanaas a medicine. Id. Additionally, the raw research datatypically were not available in a format that would allow

adequate scientific scrutiny of whether the data demonstratesafety or efficacy.Id.


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DHHS gave the DEA its evaluation and schedulingrecommendation on December 6, 2006. See id. at 40,552-66.The DEA subsequently denied the petition to reschedule onJuly 8, 2011, finding that [t]he limited existing clinicalevidence is not adequate to warrant rescheduling of marijuanaunder the CSA.Id. at 40,567.

On July 22, 2011, Petitioners filed a timely petition forreview of the DEAs decision. Petitioners argue that the DEAacted arbitrarily and capriciously when it concluded that

marijuana lacks a currently accepted medical use and has ahigh potential for abuse. They ask this court to remand thecase to the DEA for reconsideration of its decision. TheGovernment contests these assertions and responds furtherthat Petitioners, for various reasons, lack standing tochallenge the DEAs determination in court.

After oral argument, mindful of our independentobligation to be sure of our jurisdiction, we requestedsupplemental filings on Petitioners standing. Sierra Club v.EPA, 292 F.3d 895, 898 (D.C. Cir. 2002); see alsoAm.

Library Assn v. FCC, 401 F.3d 489, 492, 496 (D.C. Cir.2005) (requesting supplemental filings on standing where theparties reasonably believed that the initial filings hadsufficiently addressed the issue).

II. Analysis

A. Standing

To satisfy the requirements of Article III standing in acase challenging government action, a party must allege an

injury in fact that is fairly traceable to the challengedgovernment action, and it must be likely, as opposed tomerely speculative, that the injury will be redressed by afavorable decision.Natl Wrestling Coaches Assn v. U.S.


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Dept of Educ., 366 F.3d 930, 937 (D.C. Cir. 2004) (quotingDefenders of Wildlife, 504 U.S. at 560-61). Petitioners haveadvanced several theories of standing in this case for each ofthe various parties. However, to proceed to the merits of theirclaims, we need only find one party with standing. SeeTozziv. U.S. Dept of Health and Human Servs., 271 F.3d 301, 310(D.C. Cir. 2001) (declining to address standing of remainingappellants after finding one appellant with standing). Becausewe conclude that petitioner Michael Krawitz has individualstanding, we need not address the issue for the otherPetitioners.

1. Petitioners Burden of Production

Before seeking review in this court, Petitioners wereunder no obligation to establish Article III standing. SeePfizer Inc. v. Shalala, 182 F.3d 975, 980 (D.C. Cir. 1999)(An administrative agency, which is not subject to Article IIIof the Constitution of the United States and related prudentiallimitations, may issue a declaratory order in mere anticipationof a controversy or simply to resolve an uncertainty.).

However, when a federal court of appeals reviews an agencyaction, Article III standing must be demonstrated as it wouldbe if such review were conducted in the first instance by thedistrict court.Sierra Club, 292 F.3d at 899.

A petitioners burden of production in the court ofappeals is accordingly the same as that of a plaintiff movingfor summary judgment in the district court: it must supporteach element of its claim to standing by affidavit or otherevidence.Id. (quoting Defenders of Wildlife, 504 U.S. at561). Its burden of proof is to show a substantial

probability that it has been injured, that the defendant causedits injury, and that the court could redress that injury.Id.(quoting Am. PetroleumInst. v. EPA, 216 F.3d 50, 63 (D.C.


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Cir. 2000)). In assessing [Petitioners] standing, we mustassume they will prevail on the merits of their claims.NB exrel. Peacock v. District of Columbia, 682 F.3d 77, 82 (D.C.Cir. 2012).

If the parties reasonably, but mistakenly, believed that theinitial filings before the court had sufficiently demonstratedstanding, the court may as it did here, see Order, Oct. 16,2012 request supplemental affidavits and briefing todetermine whether the parties have met the requirements for

standing. See, e.g.,Pub. Citizen, Inc. v. Natl Highway TrafficSafety 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 aboutstanding); Am. Library Assn, 401 F.3d at 492, 496.Petitioners submitted supplemental filings on October 25,2012, offering factual information in support of Krawitzsstanding. See generallySupp. Krawitz Aff; Petrs Supp. Br.The Government was afforded an opportunity to respond toPetitioners supplemental filing and did so on November 1,

2012.

The dissenting opinion argues that we should decline toconsider Petitioners supplemental filings because theyallegedly rest on a new theory of standing and, thus, violatethe commands of Circuit Rule 28(a)(7) and, relatedly, SierraClub and its progeny. We disagree.

Circuit Rule 28(a)(7) states:

In cases involving direct review in this court ofadministrative actions, the brief of the appellant or

petitioner must set forth the basis for the claim ofstanding. . . . When the appellants or petitioner'sstanding is not apparent from the administrative record,


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the brief must include arguments and evidenceestablishing the claim of standing.

D.C.CIR.R. 28(a)(7). In this case, Petitioners obviously madea serious effort to satisfy the requirements of the rule bysetting forth their evidence and arguments in support ofstanding in their opening brief to the court. See Petrs Br. at5-7. In addition, Circuit Rule 28(a)(7) does not itself imposeany jurisdictional requirements. So even assuming, arguendo,that Petitioners failed to adhere to the briefing requirements of

the rulewhich has not been shown in this case this wouldnot compel sua sponte dismissal by the court.

Because the briefing requirements of Circuit Rule28(a)(7) are not jurisdictional, they have no relevance hereunless the Government raised a viable objection pursuant tothe rule. The Government raised no such objection toPetitioners opening brief to the court. Likewise, in itsresponse to Petitioners supplemental filings, the Governmentdid not contend that Petitioners had infringed Circuit Rule28(a)(7) or Sierra Club and its progeny. Rather, the

Government merely noted that Petitioners supplementalfilings stated, for the first time, that [Krawitz] participates inthe Oregon Medical Marijuana Program. Supp. Br. forRespt at 1. The Government did not protest that Krawitzraised a new standing theory, as the dissenting opinionargues. Nor did the Government claim that Petitionerssupplemental submissions on standing should not beaddressed by the court because they failed to satisfy therequirements of Circuit Rule 28(a)(7) or the controlling law ofthe circuit. Indeed, the Government did not even suggest thatit was disadvantaged in the adversarial process because of the

nature of Petitioners supplemental filings. See Sierra Club,292 F.3d at 901. The Governments arguments in response toPetitioners supplemental filings focused on its claim that


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Petitioners had failed to demonstrate Krawitzs Article IIIstanding.

Although Petitioners made a reasonable effort to satisfythe command of Circuit Rule 28(a)(7) in their opening briefby advancing evidence and arguments in support of standing,the court still had questions regarding whether the factsasserted by Petitioners were sufficient to satisfy therequirements of Article III standing. Therefore, the panelmajority, adhering to well-established circuit law, requested

supplemental briefing after oral arguments. Nothing in thetext of the rule bars the court from requesting such filings.As Judge Kavanaugh noted in Public Citizen, Inc. v. NationalHighway Traffic Safety Administration:

This Court retains the discretion to seek supplemental

submissions from the parties if it decides that moreinformation is necessary to determine whether petitioners,in fact, have standing. Am. Library Assn v. FCC, 401F.3d 489, 494 (D.C. Cir. 2005); see, e.g., Am. ChemistryCouncil v. Dept of Transp., 468 F.3d 810, 815 (D.C. Cir.

2006) ([W]e raised the issue of standing at oral argumentand requested supplemental briefing.); Action on

Smoking & Health v. Dept of Labor, 100 F.3d 991, 992(D.C. Cir. 1996) (petitioner furnished post-argumentaffidavits 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 firstchallenged standing after panel opinion issued).

489 F.3d at 1296.

The point here is simple: under the law of this circuit, themembers of a panel retain discretion to seek supplemental


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submissions on standing to fulfill the obligation of the court todetermine whether the requirements of Article III have beenmet. Circuit Rule 28(a)(7) does not preclude this, nor does thelaw of the circuit. The reason is clear. Circuit Rule 28(a)(7)says only that [w]hen the appellants or petitioners standingis not apparent from the administrative record, the brief mustinclude arguments and evidence establishing the claim ofstanding. D.C. CIR. R. 28(a)(7). This language is hardly freefrom ambiguity because what may be apparent from theadministrative record to one reasonable person may seemless clear to another. And some parties may be unsurewhether to explore every conceivable avenue of standing inthe first instance in light of the admonition in Sierra Clubcautioning advocates to submit only a concise recitation ofthe basis [for standing]. 292 F.3d at 901 (emphasis added);see alsoAm. Library Assn, 401 F.3d at 494 (noting that agotcha construction of Circuit Rule 28(a)(7) and SierraClubis inconsistent with our precedent and would have theundesirable effect of causing parties to include longjurisdictional statements in practically all opening briefs forfear 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 plausiblearguments and offers concrete evidence in support of standingin its opening brief, reasonably assuming that nothing more isnecessary, and the members of the panel still have questions.In such circumstances, as our case law shows, the court actswith prudence in applying Circuit Rule 28(a)(7) and indetermining 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


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DEAs continued classification of marijuana as a Schedule Idrug because it deprives him of services that he is entitled toreceive free of charge from the VA. The record indicates that,as a condition of his pain management treatment, Krawitz wasasked by VA officials to sign a Contract for ControlledSubstance Prescription that would prohibit him from, inter

alia, using medical marijuana. See Supp. Krawitz Aff. 7; seealso Krawitz Aff. Ex.1. Krawitz claims that, because herefused to sign this contract, he is now required to seek paintreatment outside the VA system. See Supp. Krawitz Aff. 8-10. Petitioners also contend that Krawitz suffers injurybecause a separate VA policy forces him to pay for a non-VAphysician in Oregon to obtain the referral forms required toparticipate in that states medical marijuana program. See id. 11-15. Petitioners argue that both of these injuries arecaused by the DEAs continued decision to classify marijuanaas a Schedule I drug and would be redressed by a favorabledecision from this court. In response, the Government arguesthat Petitioners cannot prove redressability because theirconclusion that rescheduling will result in any relief from theVA is too speculative.

The first element of the irreducible constitutionalminimum of standing is injury in fact, meaning an invasionof a legally protected interest which is (a) concrete andparticularized, and (b) actual or imminent, not conjectural orhypothetical. Defenders of Wildlife, 504 U.S. at 560(citations omitted) (internal quotation marks omitted).Petitioners clearly establish injury in fact here andRespondents 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 orknowledge of the veterans condition. 38 C.F.R. 17.38(a)(1)(xv) (2012). This policy is implemented by VHA


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Directive 2008-071, which states that clinicians must honorall requests by patients for completion of non-VHA medicalforms. Supp. Krawitz Aff. Ex. 2. However, pursuant to VHADirective 2011-004: It is VHA policy to prohibit VAproviders from completing forms seeking recommendationsor opinions regarding a Veterans participation in a Statemarijuana program. Supp. Krawitz Aff. Ex. 1. Thus, toparticipate in Oregons medical marijuana program, Krawitzconsults with a non-VA physician in Oregon at an annual costof approximately $140.00. See Supp. Krawitz Aff. 15. Inbeing forced to pay out-of-pocket for care that he couldotherwise receive freely from the VA system, Krawitz clearlysuffers an actual and concrete injury to his legallyprotected interest.Defenders of Wildlife, 504 U.S. at 560; cf.Peacock, 682 F.3d at 83 (holding that procedural violationsthat threaten an individuals ability to obtain Medicaidcoverage of prescription medications constitute injury infact).

Beyond injury in fact, we must determine whetherKrawitzs injuries have been caused by the DEAs decision to

continue listing marijuana as a Schedule I drug and whetherthere is a substantial probability that the relief requestedwould redress the injury. SeeNatl Wrestling Coaches Assn,366 F.3d at 944. The modest complexity of these questionsarises from the fact that the agency action challenged byPetitioners i.e. the DEAs continued classification ofmarijuana as a Schedule I drug is not the direct cause ofKrawitzs injury. Rather, his injury is caused by the actions ofthe VA system, which has decided as a matter of policy not toassist patients in obtaining substances illegal under federallaw. This court has addressed standing under analogous

circumstances in at least four previous decisions. In thosecases, we looked for whether the record presented substantialevidence of a causal relationship between the government


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policy and the third-party conduct, leaving little doubt as tocausation and the likelihood of redress.Id. at 941. In two ofthose decisions, we found standing. In the other two, wedenied standing. This case more strongly resembles theformer two.

InBlock v. Meese, 793 F.2d 1303, 1308 (D.C. Cir. 1986),the plaintiffs company owned exclusive distribution rights toa film that the Justice Department classified as politicalpropaganda. The plaintiff alleged injury to his economic

interests because the classification deterred potentialcustomers. Id. To support this assertion, the plaintiffsubmitted declarations and affidavits from potential customerswho were dissuaded from purchasing the film because of itsstatus as propaganda.Id. We held that there was sufficientfactual evidence on the record to establish that the harm wasattributable to the classification.Id.

In Tozzi v. U.S. Department of Health and HumanServices, 271 F.3d 301 (D.C. Cir. 2001), a manufacturer ofPVC plastic challenged a decision by the Secretary of Health

and Human Services to list dioxin, a chemical releasedthrough the incineration of PVC plastic, as a knowncarcinogen. Though this triggered no new federal regulation,the manufacturer sued on the theory that the classification hadprompted state and local entities to regulate to the detrimentof the manufacturer. Id. at 309. Looking carefully at therecord, we found several reasons to conclude that thegovernment action was at least a substantial factormotivating the third parties actions.Id. at 308. We notedthat Congress intended the Secretarys determination toserve as the federal governments authoritative statement on

the current state of knowledge regarding the carcinogenicityof various chemicals.Id. at 309 (citing H.R. REP. NO. 95-1192, at 28 (1978) (describing the Secretarys list as a


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comprehensive document containing all known orsuspected carcinogenic agents)). We also noted that theSecretarys list of carcinogens is widely disseminated andhighly influential, and we pointed to several localgovernment restrictions on the use of PVC plastic thatexplicitly cited the Secretarys determination that dioxin is aknown carcinogen. Id. We also found it significant that theterm carcinogen is inherently pejorative and damaging,noting that this increased the probability of an economicallyharmful third party response.Id.

In at least two other cases, we have denied standing whena non-partys conduct was the most direct cause of the allegedinjury. InNational Wrestling Coaches Assn, 366 F.3d at 933,several membership organizations that represent[ed] theinterests of collegiate mens wrestling coaches, athletes, andalumni challenged the governments Title IX enforcementpolicy, alleging that it had caused several schools to canceltheir mens wrestling programs. We denied standing,reasoning that the plaintiffs offer[ed] nothing but speculationto substantiate their claim that a favorable decision from this

court [would] redress their injuries by altering these schoolsindependent decisions.Id. at 937. And in Renal PhysiciansAssn v. U.S. Department of Health & Human Services, 489F.3d 1267 (D.C. Cir. 2007), a medical association challengeda government regulation that allegedly depressed theircompensation for in-house patient referrals. Once again, thiscourt denied standing, concluding it was speculative, notlikely, that rescinding the regulation would increase the rateof compensation.Id. at 1277.

Turning to the facts of this case, the causation element is

satisfied because Krawitzs injury is fairly traceable to theGovernments decision to continue listing marijuana as aSchedule I drug. As with the statute in Tozzi, Congress made


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clear when it passed the CSA that the agencys schedulingdecisions should serve as the federal governmentsauthoritative statement on the legitimacy of particularnarcotics and dangerous drugs. 271 F.3d at 309. The HouseReport for the CSA explains that Congress had alreadyenacted more than 50 pieces of legislation relating to theregulation of dangerous drugs. H.R. REP. NO. 91-1444,reprinted in 1970 U.S.C.C.A.N. 4566, 4571. Congressintended the CSA and its scheduling program to collect[] andconform[] these diverse laws in one piece of legislation.Id.Furthermore, the Governments classification of marijuanaunder Schedule I is inherently pejorative.Tozzi, 271 F.3d at309. Under the terms of the Act, a Schedule I drug has a highpotential 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 aSchedule I drug, pursuant to its delegated authority under theCSA, it announced an authoritative value judgment that surelywas meant to affect the policies of third-party federalagencies.

Unsurprisingly, the VA has heeded the DEAs judgmentregarding marijuana, thus making the question of causationrelatively easy in this case. The record before the court clearlyshows that the VAs refusal to complete Krawitzs medicalmarijuana forms is traceable to the DEAs continued decisionto classify marijuana as Schedule I. VHA Directive 2011-004,which prohibits VA providers from completing state medicalmarijuana forms, cites three times to marijuanas Schedule Istatus. See Supp. Krawitz Aff. Ex. 1. Indeed, compliance withthe CSA is the only justification the Directive cites for thispolicy. See id.([VA] providers must comply with all Federal

laws, including the Controlled Substances Act. Marijuana isclassified as a Schedule I drug under the ControlledSubstances Act.). In light of this evidence, the Government,


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in its brief to the court, offers nothing more than a perfunctorychallenge to causation. This case is nothing like the situationsin National Wrestling and Renal Physicians, where therecords contained only weak evidence of causal links betweenthe claimants injuries and the contested actions of third-partydefendants.

The Government focuses most on redressability incontesting Krawitzs standing in this case. The Governmentargues that rescheduling marijuana would not generate a

significant increase in the likelihood that the VA wouldauthorize 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 suggeststhat, based on the current scientific evidence, there would beno approval by the Food & Drug Administration of medicalmarijuana, and, absent such approval, VA physicians wouldbe unlikely to recommend a substance that could not beprescribed or readily subjected to supervised use.

The Governments argument against redressability fails.

The issue is not whether VA physicians would recommendmarijuana usage to patients. The issue is only whetherrescheduling marijuana would generate a significant increasein the likelihood that Krawitz could obtain completed statemedical marijuana forms from the VA. See id. Under existingregulations and VHA Directive 2008-071, VA clinicians aresubject to a non-discretionary duty to honor all requests bypatients for completion of non-VHA medical forms.See 38C.F.R. 17.38(a)(1)(xv) (2012); Supp. Krawitz Aff. Ex. 2.The only thing stopping VA clinicians from performing thisduty with respect to Krawitzs request is VHA Directive

2011-004. See Supp. Krawitz Aff. Ex. 1. The only reason theVA cites for implementing VHA Directive 2011-004 is theclassification of marijuana as a Schedule I drug.Id. Therefore,


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were marijuana rescheduled to reflect its potential for medicaluse, the VA would have no expressed reason to retain VHADirective 2011-004 and VA clinicians would likely be subjectto a non-discretionary duty to complete Krawitzs statemedical marijuana forms.

This case is fully distinguishable fromNational WrestlingandRenal Physicians,where we found redressability lacking.In both those cases, in addition to a tenuous showing ofcausation, there were reasons beyond the challenged

government action for the third parties to continue theconduct that caused injury to the plaintiffs. In NationalWrestling there were many factors that led each school tocancel its mens wrestling program, such as the absence ofleague sponsorship for wrestling, budgetary concerns, and theneed to balance the athletic program with other Universitypriorities. 366 F.3d at 942. Furthermore, Title IX and itsaccompanying regulations would have remained in forceregardless of the cases outcome. See id. at 943. Indeed theplaintiffs in National Wrestling did not even contest thelegality of the Title IX regulations.Id. InRenal Physicians the

court found that the plaintiffs had failed to demonstrateredressability in part because, even if the challengedregulation were struck down, market forces might drive theinjurious conduct to continue. See 489 F.3d at 1277.

In contrast, this case is more like Tozzi. There we found itsignificant for redressability that the Secretarys listing ofdioxin as a known carcinogen was the only suchpronouncement by the federal government. See 271 F.3d at309-10. Therefore, if we had set aside that listing, dioxinactivists could no longer point to an authoritative

determination by the United States government that dioxin isknown to cause cancer in humans. . . . State and localgovernments would be less likely to regulate dioxin, and


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healthcare companies would in turn be less likely to stopusing PVC plastic.Id. at 310. Here, the Schedule I listing isthe authoritative federal declaration of marijuanas illegalityand unfitness for medical use. The VA is a federal agency andthus surely inclined to subscribe to such a federal declaration.Were the substance rescheduled, the VA would lose the onlyexpress justification for its policy against completing statemedical marijuana forms. Therefore, it is likely instead ofmerely speculative that Krawitzs injury would beredressed.

Because Krawitz has Article III standing due to hisinability to have the VA system complete his state medicalmarijuana forms, we need not consider whether his allegedinability to obtain pain management services from the VA inVirginia warrants standing. We also need not considerwhether the other Petitioners have standing as well. SeeWattv. Energy Action Educ. Found., 454 U.S. 151, 160 (1981)(Because we find [one plaintiff] has standing, we do notconsider the standing of the other plaintiffs.); see alsoTozzi,271 F.3d at 310 (same).

B. The DEAs Denial of the Petition to Initiate

Proceedings to Reschedule Marijuana

On the merits, Petitioners claim that the DEAs finalorder denying their request to initiate proceedings toreschedule marijuana was arbitrary and capricious. Under theterms of the CSA, marijuana cannot be rescheduled toSchedules III, IV, or V without a currently accepted medicaluse. 21 U.S.C. 812(b)(3)-(5). To assess whether marijuanahas such a medical use, the agency applies a five-part test:

(1) The drugs chemistry must be known and reproducible;(2) There must be adequate safety studies; (3) There must beadequate and well-controlled studies proving efficacy; (4) The


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drug must be accepted by qualified experts; and (5) Thescientific evidence must be widely available.SeeDenial, 76Fed. Reg. 40,552, 40,579. The DEAs five-part test wasexpressly approved by this court in Alliance for CannabisTherapeutics,15 F.3d at 1135. Because the agencys factualfindings in this case are supported by substantial evidence andbecause those factual findings reasonably support theagencys final decision not to reschedule marijuana, we mustuphold the agency action.

Under the Administrative Procedure Act, a court may setaside an agencys final decision only if it is arbitrary,capricious, an abuse of discretion, or otherwise not inaccordance with law. 5 U.S.C. 706(2)(A). We will notdisturb the decision of an agency that has examine[d] therelevant data and articulate[d] a satisfactory explanation forits action including a rational connection between the factsfound and the choice made.MD Pharm. Inc. v. DEA, 133F.3d 8, 16 (D.C. Cir. 1998) (quoting Motor Vehicle Mfrs.Assn v. State Farm Mut. Auto. Ins. Co. , 463 U.S. 29, 43(1983)). Furthermore, the agencys interpretation of its own

regulations must be given controlling weight unless it isplainly erroneous or inconsistent with the regulation.ThomasJefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994). TheCSA also directs this court to review the agencys findings offact for substantial evidence. See 21 U.S.C. 877. Under thisstandard, we must ask whether a reasonable mind mightaccept a particular evidentiary record as adequate to support aconclusion.Dickinson v. Zurko, 527 U.S. 150, 162 (1999).

Petitioners do not seriously dispute the propriety of thefive-part test approved inAlliance for Cannabis Therapeutics.

Thus, they are left with the difficult task of showing that theDEA has misapplied its own regulations. Petitioners challengethe agencys reasoning on each of the five factors. However,


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[a] drug will be deemed to have a currently accepted medicaluse for CSA purposes only if all five of the foregoingelements are demonstrated.Denial, 76 Fed. Reg. at 40,579.In this case, we need only look at one factor, the existence ofadequate and well-controlled studies proving efficacy, toresolve Petitioners claim.

In its scientific and medical evaluation, DHHS concludedthat research on the medical use of marijuana ha[d] notprogressed to the point that marijuana [could] be considered

to have a currently accepted medical use or a currentlyaccepted medical use with severe restrictions.Id. at 40,560.As noted above, DHHS recommendations are binding on theDEA insofar as they rest on scientific and medicaldeterminations. 21 U.S.C. 811(b). After an exhaustiveexamination of the issue, the DEA, adhering to DHHSrecommendation, reached the following conclusion:

To establish accepted medical use, the effectiveness of adrug must be established in well-controlled, well-designed, well-conducted, and well-documented

scientific studies, including studies performed in a largenumber of patients (57 FR 10499, 1992). To date, suchstudies have not been performed. The small clinical trialstudies with limited patients and short duration are notsufficient to establish medical utility. Studies of longerduration are needed to fully characterize the drugsefficacy and safety profile. Scientific reliability must beestablished in multiple clinical studies. Furthermore,anecdotal reports and isolated case reports are notadequate evidence to support an accepted medical use ofmarijuana (57 FR 10499, 1992). The evidence from

clinical research and reviews of earlier clinical researchdoes not meet this standard.


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Denial, 76 Fed. Reg. at 40,579.

Petitioners contest these findings, arguing that theirpetition to reschedule marijuana cites more than two hundredpeer-reviewed published studies demonstrating marijuanasefficacy for various medical uses, and that those studies werelargely ignored by the agency. As we explain below,Petitioners singular reliance on peer-reviewed studiesmisses the mark. It is also noteworthy that Petitioners brief tothis court fails to convincingly highlight any significant

studies allegedly ignored by DHHS or the DEA.

Petitioners argument focuses at length on one studytheMarch 1999 report from the Institute of Medicine (IOM)that was clearly addressed by the DEA. The IOM report doesindeed 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 withAIDS or who are undergoing chemotherapy, and who suffersimultaneously from severe pain, nausea, and appetite loss,

cannabinoid drugs might offer broad-spectrum relief notfound in any other single medication.). However, the DEAfairly construed this report as calling for more and betterstudies to determine potential medical applications ofmarijuana and not as sufficient proof of medical efficacyitself.Denial, 76 Fed. Reg. at 40,580. In other words, whilethe IOM report did support further research into therapeuticuses of cannabinoids, the IOM report did not recognize

marijuanas accepted medical use but rather the potential

therapeutic utility of cannabinoids.Id.

At bottom, the parties dispute in this case turns on theagencys interpretation of its own regulations. Petitionersconstrue adequate and well-controlled studies to mean peer-


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reviewed, published studies suggesting marijuanas medicalefficacy. The DEA, in contrast, interprets that factor to requiresomething more scientifically rigorous. In explaining itsconclusion that there is a lack of clinical evidence establishingmarijuanas currently accepted medical use, the agency saidthe following:

[A] limited number of Phase I investigations have beenconducted 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 initialtesting in human subjects, generally involving 20 to 80patients.Id. They are designed primarily to assess initialsafety, tolerability, pharmacokinetics, pharmaco-dynamics, and preliminary studies of potentialtherapeutic benefit. (62 FR 66113, 1997). Phase II andPhase III studies involve successively larger groups ofpatients: usually no more than several hundred subjectsin Phase II and usually from several hundred to severalthousand in Phase III. 21 C.F.R. 312.21. These studiesare designed primarily to explore (Phase II) and to

demonstrate or confirm (Phase III) therapeutic efficacyand benefit in patients. (62 FR 66113, 1997). No Phase IIor Phase III studies of marijuana have been conducted.Even in 2001, DHHS acknowledged that there issuggestive evidence that marijuana may have beneficialtherapeutic effects in relieving spasticity associated withmultiple sclerosis, as an analgesic, as an antiemetic, as anappetite stimulant and as a bronchodilator. (66 FR20038, 2001). But there is still no data from adequate andwell-controlled clinical trials that meets the requisitestandard to warrant rescheduling.

Id. at 40,579-80.


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The DEA interprets adequate and well-controlledstudies to mean studies similar to what the Food and DrugAdministration (FDA) requires for a New Drug Application(NDA). See id. at 40,562. DHHS found that there havebeen no NDA-quality studies that have scientifically assessedthe efficacy of marijuana for any medical condition.Id. It iswell understood that, under FDA protocols, adequate andwell-controlled investigations require clinicalinvestigations, by experts qualified by scientific training andexperience to evaluate the effectiveness of the drug involved,on the basis of which it could fairly and responsibly beconcluded by such experts that the drug will have the effect itpurports or is represented to have under the conditions of useprescribed, recommended, or suggested in the labeling orproposed labeling thereof. 21 U.S.C. 355(d). This is arigorous standard. See, e.g., Edison Pharm. Co. v. FDA,600F.2d 831, 843 (D.C. Cir. 1979) (holding that substantialevidence supported the FDAs conclusion that double-blindtesting of a new drug was necessary before the drug could beadministered to cardiac patients); Holland-Rantos Co. v. U.S.Dept of Health, Educ. and Welfare, 587 F.2d 1173, 1174

(D.C. Cir. 1978) (refusing to construe the requirement of awell-controlled investigation in a self-defeating fashion).

Contrary to what Petitioners suggest, something morethan peer-reviewed studies is required to satisfy DEAsstandard, and for good reason. [S]cientists understand thatpeer review per se provides only a minimal assurance ofquality, and that the public conception of peer review as astamp of authentication is far from the truth. CharlesJennings, Quality and Value: The True Purpose of PeerReview, NATURE.COM (2006), http://www.nature.com/nature/

peerreview/debate/nature05032.html; see also Lynn S.McCarty et al., Information Quality in Regulatory DecisionMaking: Peer Review versus Good Laboratory Practice, 120
http://www.nature.com/nature/%20peerreview/debate/nature05032.htmlhttp://www.nature.com/nature/%20peerreview/debate/nature05032.htmlhttp://www.nature.com/nature/%20peerreview/debate/nature05032.htmlhttp://www.nature.com/nature/%20peerreview/debate/nature05032.html


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ENVTL. HEALTH PERSP. 927, 930 (2012) (It is difficult toextract from the extensive body of work and commentarypublished over the last 25-30 years that scientific journal peerreview is a coherent, consistent, reliable, evaluativeprocedure. . . . [T]he opposite conclusion may be moreaccurate.). Petitioners may have cited some peerreviewedarticles in support of their position, but they have not pointedto adequate and well-controlled studies confirming theefficacy of marijuana for medicinal uses. If, as is the casehere, there is substantial evidence to support the [agencys]

finding that the[] studies [offered by petitioner] are nothelpful, then petitioner must fail. Unimed, Inc. v.

Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In makingthis assessment, we must remind ourselves that our role in

the Congressional scheme is not to give an independentjudgment of our own, but rather to determine whether theexpert agency entrusted with regulatory responsibility hastaken an irrational or arbitrary view of the evidenceassembled before it.Id.

The DEAs construction of its regulation is eminently

reasonable. Therefore, we are obliged to defer to the agencysinterpretation of adequate and well-controlled studies. SeeThomas Jefferson Univ., 512 U.S. at 512 (deferring to anagencys interpretation of its own regulations). Judgedagainst the DEAs standard, we find nothing in the record thatcould move us to conclude that the agency failed to prove bysubstantial evidence that such studies confirming marijuanasmedical efficacy do not exist.

Finally, Petitioners suggested during oral argument thatthe Government had foreclosed the research that would be

necessary to create sufficiently reliable clinical studies ofmarijuanas medical efficacy. Because Petitioners did notproperly raise this issue with the DEA and there is nothing in


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the record to support it, we do not consider it here. We note,however, that DHHS recommendation explained that [t]heopportunity for scientists to conduct clinical research withmarijuana exists under the [D]HHS policy supporting clinicalresearch with botanical marijuana.Denial, 76 Fed. Reg. at40,562. Thus, it appears that adequate and well-controlledstudies are wanting not because they have been foreclosed butbecause they have not been completed.

III. Conclusion

For the reasons discussed above, we hereby deny thepetition for review.


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KAREN LECRAFT HENDERSON, Circuit Judge, dissenting:

Over a decade ago, our court was compelled to remind allpetitioners of first principles, namely, they must assure us thatthey meet Article IIIs case or controversy requirement if theirstanding is not self-evident from the record. Sierra Club v.EPA, 292 F.3d 895, 900 (D.C. Cir. 2002). We subsequentlytransformed the holding into D.C. Circuit Rule 28(a)(7) to tellthe litigating world we really meant what we said in SierraClub. Since then, our precedent and our Rule seem to havebeen honored more in the breach than in compliance. We

have issued pre-argument orders alerting the parties to beprepared to address standing at oral argument because of ouruncertainty regarding standing based on the briefing. See, e.g.,Order, Cherry v. FCC, No. 10-1151 (Feb. 23, 2012). We haveallowed a secondlateopportunity to establish standing atthe reply brief stage. See Exxon Mobil Corp. v. FERC, 571F.3d 1208, 1219 (D.C. Cir. 2008). We have even asked forpost-argument briefs based on the petitioners failuretheretofore to establish standing. See Pub. Citizen, Inc. v.Natl 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 Assn v. FCC, 401 F.3d 489, 492 (D.C.Cir. 2005) (Edwards, J.) (articulating Sierra Club exception ifpetitioners reasonably [but mistakenly] believed theirstanding [was] self-evident); Communities Against RunwayExpansion, Inc. v. FAA, 355 F.3d 678, 685 (D.C. Cir. 2004)(Edwards, J.) (excusing belated submissions attached to replybrief because they made standing patently obvious); KERM,Inc. v. FCC, 353 F.3d 57, 60-61 (D.C. Cir. 2004) (notingpetitioners belated assertion of standing but nonethelessanalyzing standing arguments) (Edwards, J.). Perhaps it is too

late to blow the whistle but I do not share the solicitude mycolleagues show the petitionersno novices on their merits


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claim1here, especially in view of the fact that their standingtheory for the lone petitioner with standing is, post-argument,brand new.

Petitioners Americans for Safe Access (ASA), Coalitionfor Rescheduling Cannabis (CRC), Patients Out of Time(POT), Kathy Jordan, Michael Krawitz, Richard Steeb andWilliam Britt (petitioners) petition for review of the decisionof 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 theirpetition to initiate rulemaking proceedings to reschedulemarijuana as a Schedule I substance under the ControlledSubstances Act (CSA), 21 U.S.C. 801 et seq. The majoritydeterminesbased on his post-argument submissionthatKrawitz has standing and thus proceeds to the merits. Ibelieve the post-argument submission should not have beenallowed. Once allowed, it should not have been consideredbecause it asserts a new theory of standing. The remainingpetitioners also lack standing and therefore the petition forreview should have been dismissed.

I.

To press their claim, the petitioners must establish that atleast one of them has standing. Rumsfeld v. Forum forAcademic & 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 at

1 Two individuals who joined the petitioners quest to reschedulemarijuana at the administrative stageJon Gettman and High

Timeshad petitioned for review of DEAs earlier failure toreschedule marijuana. We dismissed their petition for lack ofstanding. Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002).


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898. Reviewing administrative action, we require that thepetitioner either identify in that record evidence sufficient tosupport its standing to seek review or, if there is none becausestanding was not an issue before the agency, submit additionalevidence to the court of appeals. Id. at 899. Three of theseven petitionersASA, CRC and POTare organizations.The remaining petitionersJordan, Krawitz, Steeb andBrittare members of ASA (ASA Members). Neither CRCnor POT has attempted to establish its standing. Theremaining petitioners assert three theories of standing: ASAsstanding asan association, the individual standing of the fourASA Members and ASAs standing representing its members.I begin with Krawitzs standing as he is the one whosestanding the majority affirms.

II.

A. Krawitzs Standing

In their opening brief, the petitioners did not distinguishKrawitz 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 andthat he used marijuana to alleviate his pain. Krawitz explainedthat he received medical benefits from the United StatesDepartment of Veterans Affairs (VA) but that

[b]ecause of my medical cannabis use, I am currentlybeing denied my prescription pain treatment by the

VA based upon their illegal drug policy that routinely,administratively, denies pain treatment as punishmentfor using cannabis by veterans that do not live in a

state with legal medical cannabis, based on VAspolicy regarding medical cannabis, which, amongother things, prohibits VA physicians from discussingtherapeutic uses of cannabis with me. A true and


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correct copy of that policy is attached hereto asExhibit 1. Although the bulk of my medical care stilloccurs at VA hospital I am now seeing an outsideM.D. for my pain treatment under the VAs fee basisprogram.

Krawitz Aff. 4 (bracketed text omitted) (emphasis added).To his affidavit, Krawitz attached a document entitledCONTRACT FOR CONTROLLED SUBSTANCEPRESCRIPTION. Krawitz Aff. Ex. 1 at 1. The document is

confusing at best, and, at worst, makes it appear as if the VAitself could be providing Krawitz with marijuana. See, e.g.,Krawitz Aff. Ex. 1 at 1 (I will not request or acceptcontrolled substance medication from any other physician orindividual while I am receiving such medication from myphysician at the Salem VAMC Clinic.). The petitioners,unhelpfully, provided no explanation of the contract in eithertheir opening or their reply briefs.

Krawitzs affidavit and exhibit failed to establishstanding. His affidavit boiled down to the averment that he

was injured because the VA had a drug policy that deniespain treatment as punishment for using cannabis by veteransthat do not live in a state with legal medical cannabis,Krawitz Aff. 4 (emphasis added). But Krawitz challengesfederal, not state law, and he has provided no evidence orargument that rescheduling marijuana under the CSA willchange the way any state regulates marijuana. Indeed, statemarijuana legislation in recent years has distinctly divergedfrom federal law. See, e.g., Gettman v. DEA, 290 F.3d 430,435 (D.C. Cir. 2002) ([S]peculative claims dependent uponthe actions of third parties do not create standing.).

Notwithstanding the failure of the petitioners showingregarding standingspecifically, Krawitzs affidavit with


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attachmentwe issued a post-argument order, giving themyet another opportunity2 to clarify and amplify the assertionsmade in paragraph 4 of the Affidavit of Michael Krawitzregarding his individual standing. I dissented from the orderbecause our precedent unequivocally directs the method bywhich a petitioner must establish standing, a method thepetitioners ignored. In 2002, we explained:

Henceforth, therefore, a petitioner whose standing isnot self-evident should establish its standing by the

submission of its arguments and any affidavits orother evidence appurtenant thereto at the firstappropriate point in the review proceeding. In somecases that will be in response to a motion to dismissfor want of standing; in cases in which no suchmotion has been made, it will be with the petitionersopening briefand not, as in this case, in reply to thebrief of the respondent agency. In either proceduralcontext the petitioner may carry its burden ofproduction by citing any record evidence relevant toits claim of standing and, if necessary, appending to

its filing additional affidavits or other evidencesufficient to support its claim. In its opening brief, thepetitioner should also include in the JurisdictionalStatement a concise recitation of the basis uponwhich it claims standing.

. . . . [A]ll too often the petitioner does not submitevidence of those facts with its opening brief and the

2 The petitioners reply brief, while providing a more detailedstanding argument and including (improperly) a supplemental

affidavit, was nonetheless deficient. With their post-argumentopportunity to supplement, the petitioners have now been allowedthree chances to establish standing.


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respondent is therefore left to flail at the unknown inan attempt to prove the negative, or the court raises itsown question about the petitioners standing and endsup having to direct the parties to file supplementalbriefs in order to ensure that the issue is joined in afair and thorough adversarial process.

Sierra Club, 292 F.3d at 900-01 (emphasis added). Wecautioned that [a]bsent good cause shown . . . a litigantshould not expect the court to depart from the above

procedure. Id. at 900. Sierra Club does not make thepetitioners showing optionalit instead constitutes bindingCircuit law. As noted earlier, we codified Sierra Club in ourCircuit Rules as follows:

In cases involving direct review in this court ofadministrative actions, the brief of the appellant orpetitioner must set forth the basis for the claim ofstanding. This section, entitled Standing, mustfollow the summary of argument and immediatelyprecede the argument. When the appellants or

petitioners standing is not apparent from theadministrative record, the brief must includearguments and evidence establishing the claim ofstanding. See Sierra Club v. EPA, 292 F.3d 895, 900-01 (D.C. Cir. 2002). If the evidence is lengthy, andnot contained in the administrative record, it may bepresented in a separate addendum to the brief.

D.C. Cir. R. 28(a)(7); see alsoIntl 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 toquestioning by the court); Exxon Mobil, 571 F.3d at 1220(declining to consider standing theory first articulated at oral


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argument). The petitioners had made no effort to show goodcause3 for their initial failure to establish standing. And, thisbeing so, I opposed giving them yet another opportunity toestablish standing.

In response to the order, the petitioners filed asupplemental brief with a new Krawitz affidavit, featuring anew theory of standing. He avers, for the first time, that hespends one or two months per year in Oregon, where heobtains marijuana for medical use. To obtain medicinal

marijuana in Oregon, a person must apply for a registrationcard, which requires him to submit annually [v]alid, writtendocumentation from the persons attending physician statingthat the person has been diagnosed with a debilitating medicalcondition and that the medical use of marijuana may mitigatethe symptoms or effects of the persons debilitating medicalcondition. See Or. Rev. Stat 475.309(2), (7)(C)(i). Krawitzcomplains that the VA has a policyVHA Directive 2011-004prohibiting its physicians from providing suchdocumentation, thus forcing him to pay $140.00 per year toconsult an Oregon physician who can so provide.

Unlike his original affidavitin which Krawitz declaredthat the VA denied him pain treatmentKrawitzs newaffidavit states that the VA is notdenying him treatment forpain based on his marijuana use. Moreover, VHA Directive2011-004 makes plain that the VA does nothave a policy ofdenying 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 areasonable belief its standing was self-evident, seeAm. Library

Assn, 401 F.3d at 492 or if supplemental declarations submittedwith a reply brief made standing patently obvious, seeCommunities Against Runway Expansion, 355 F.3d at 685.


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prohibit Veterans who participate in State marijuana programsfrom also participating in VHA . . . pain control programs . . .[D]ecisions to modify treatment plans in those situations needto be made by individual providers in partnership with theirpatients. VHA Directive 2011-004 (Jan. 31, 2011), availableat http://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=2362.

In other words, Krawitz asserts a new injury-in-facta$140.00 per year pocketbook injurythat is nowhere to be

found in even the most generous reading of his originalaffidavit. As we have earlier held, however, we are aware ofno authority which permits a party to assert an entirely newinjury (and thus, an entirely new theory of standing) in itsreply brief. Coal. for Responsible Regulation, Inc. v. EPA,684 F.3d 102, 147 (D.C. Cir. 2012) (per curiam) (emphasisadded). And plainlyuntil todaywe have neverpermitted apetitioner to assert an entirely new injury and theory ofstanding in a post-argumentsubmission.

4

4 Oregons policynot that of the VA or of DEAis the directcause of Krawitzs annual $140.00 injury because, if Oregoneliminated the physician documentation requirement, Krawitzsinjury would be immediately redressed. By contrast, if we orderedDEA to reschedule marijuana, the VA might rescind VHADirective 2011-004 and Krawitzs VA physician might completethe Oregon documentation for Krawitz. See MemorandumRegarding State Medical Marijuana Registration Forms fromDepartment of Veterans Affairs General Counsel to UnderSecretary of Health at 5 (May 21, 2008) (cited by VHA Directive2011-004) (stating, prior to promulgation of VHA Directive 2011-

004, [a]t present, the language of 38 C.F.R. 17.38(c)(3) does notrequire the completion of [medical marijuana] forms by VHAphysicians [because t]his regulatory provision eliminates non-FDA


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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 issufficient to satisfy Article III's case-or-controversyrequirement.). Because I believe Krawitz lacks standing, Imust consider the other petitioners standing.

B. Other Petitioners Standing

ASAs Organizational Standing

In their opening brief, the petitioners asserted that ASAhas standing as an organization because it must expendsignificant resources combatting the DEAs positionsrespecting marijuanas medical use and abuse potential, whichwould be redressed by a favorable decision. Petrs OpeningBr. 6. In their reply brief, they argue ASA has been unable toemploy a full-time California Director to interface withgovernment agencies in California and those of other medicalmarijuana states to implement state law, in particular, theregulation of medical marijuana dispensaries. Petrs Reply

Br. 3 (citing Sherer Supp. Aff. 2).

An organization does not have standing based on a mere setback to [its] abstract social interests. Natl Assn ofHome Builders v. EPA, 667 F.3d 6, 11 (D.C. Cir. 2011)(quotingNatl Taxpayers Union, Inc. v. United States, 68 F.3d1428, 1433 (D.C. Cir. 1995)). An associations self-servingobservation that it has expended resources to educate itsmembers and others regarding [a challenged statutoryprovision] 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 alsoVHA Directive 2011-004, supra.


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subjected [the association] to operational costs beyond thosenormally expended to review, challenge, and educate thepublic. Natl Taxpayers Union, 68 F.3d at 1434. Nor isstanding found when the only injury arises from the effectof the regulations on the organizations lobbying activities.Ctr. for Law & Educ. v. Dept of Educ., 396 F.3d 1152, 1161(D.C. Cir. 2005).

The petitioners support ASAs organizational standing byrelying on Havens Realty Corp. v. Coleman, 455 U.S. 363

(1982). InHavens, a nonprofit corporation sued the owner ofan apartment complex for damages under the Fair HousingAct because the [discriminatory] practices of [the apartmentcomplex] had frustrated the organizations counseling andreferral services, with a consequent drain on resources.Id. at369. The Supreme Court upheld the nonprofits standingbecause the practices have perceptibly impaired [its] abilityto provide counseling and referral services for low-andmoderate-income homeseekers . . . . Such concrete anddemonstrable injury to the organizations activitieswith theconsequent drain on the organizations resourcesconstitutes

far more than simply a setback to the organizations abstractsocial 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 wefound two organizations had standing to assert a claim forinjunctive relief and damages under the Fair Housing Actbecause the discriminatory conduct required [plaintiffs] todevote more time, effort, and money to endeavors designed toeducate 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 plausiblyrequired). We emphasized the difference between this suit


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and one presenting only abstract concerns or complaints aboutgovernment policy; specifically, the plaintiffs do not seek tocompel government action, [or] to involve the courts in amatter that could be resolved in the political branches butrather are private actors suing other private actors, traditionalgrist for the judicial mill.Id. at 30.

Unlike Havens and Spann, this case does not involveprivate actors suing other private actors, traditional grist forthe judicial mill. Id. Nor does it involve a suit for damages

under a federal statute (like the Fair Housing Act) that createsa cause of action. Instead, it serves to compel governmentaction, [and] to involve the courts in a matter that could beresolved in the political branches.5Id. Moreover, ASAsasserted injurythat it must spend money to educate thepublic about the true benefits of marijuana and to lobby[ ]local, state and federal governments, Sherer Aff. 8, 12isessentially an argument that ASA cannot allocate issueadvocacy expenses in the way it would prefer, which isinsufficient to establish standing. See Ctr. for Law & Educ.,396 F.3d at 1162 (The only service impaired is pure issue-

advocacythe very type of activity distinguished byHavens.). Nor have the petitioners explained how ASAwould be able to avoid these expenditures if marijuana wererescheduled. For example, ASA would still need to meet thesubstantial scientific evidenceidentified by DEAthatrejects its position regarding marijuanas medical efficacy.Similarly, ASA would need to counter statements made by

5 ASA and similar organizations have had great political success inrecent years. See, e.g., Louise Radnofsky, Voters Weigh SocialIssues, 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 recreationaluse).


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entities other than DEA (including the very state and localgovernments they are lobbying) that oppose legalization ofmarijuana for medical use. SeeNatl Taxpayers Union, 68F.3d at 1434 (There is no evidence that [the challengedstatutory provision] has subjected [the association] tooperational costs beyond those normally expended to review,challenge, and educate the public.).

The closest the petitioners come to establishing an injuryto ASA as an organization is their statement that [s]ince

2006, due to expenditures made by ASA to offset the falsestatements made by the [DEA and HHS] that marijuana hasno medical use and is extremely dangerous, ASA has beenunable to hire a full-time California Director. Sherer Supp.Aff 2. But whatever happened in 2006 that prevented ASAfrom hiring a full-time California Director, it could not havebeen marijuanas Schedule I listing because marijuana hasbeen 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 Membersother than Krawitz have their own individual standing. Intheir opening brief, they assert that if marijuana were removedfrom Schedule I, the three would no longer be deterred fromcultivating their own medicine . . . since they would likely beafforded a medical necessity defense in federal court. PetrsOpening Br. 7. Nevertheless, speculative claims dependentupon the actions of third parties do not create standing.Gettman, 290 F.3d at 434-35 (dismissing petitionfor lack ofstandingof marijuana researcher who argued DEA decision

not to reschedule marijuana decreased his potential customersand diminished his ability to conduct research). Here, thecausal chain is even more speculative. ASAs Members allege


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that their injury could be redressed by a favorable rulingbecause (1) if marijuana were rescheduled; and (2) if theychose to cultivate marijuana; and (3) if the federalgovernment detected the cultivation; and (4) if the federalgovernment prosecuted the cultivators; and (5) if thecultivators asserted a medical necessity defense; and(6) if thecourt accepted the medical necessity defense; then (7) theywould avoid criminal liability for cultivation.6

Moreover, the existence of a medical necessity defense

for marijuana cultivation is tenuous at best. The petitionersassert that marijuanas Schedule I status is the only thingpreventing courts from recognizing the defense, citing UnitedStates v. Oakland Cannabis Buyers Coop., 532 U.S. 483(2001), which held that no medical necessity defense existsfor the illegal distribution of various controlled substances,including marijuana, because the CSA reflects adetermination that marijuana has no medical benefits worthyof an exception. Id. at 491. The Courts 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 FirstAmendment, 99 MICH. L. REV. 281, 329 n.168 (2000) (quotingMother Gooses Nursery Rhymes 191 (Walter Jerrold ed., Alfred

A. Knopf Inc. 1993) (1903)). While a lost nail may lead to a lostkingdom, establishing Article III standing requires more than agood imagination.


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clear, however, that rescheduling marijuana would notnecessarily produce a medical necessity defense because it isan open question whether federal courts ever have authority torecognize a necessity defense not provided by statute. Id. at490 (Even at common law, the defense of necessity wassomewhat controversial.).

Assuming arguendo the three ASA Members decide tocultivate marijuana, it is far from likely that a federalprosecutor would exercise his discretion to prosecute. In fact,

the Department of Justice recently suggested that it did notconsider it an efficient use of resources to prosecuteindividuals with cancer or other serious illnesses who usemarijuana as part of a recommended treatment regimenconsistent with applicable law, or those caregivers in clearand unambiguous compliance with existing state law whoprovide such individuals with marijuana. David W. Ogden,Deputy Attorney General, U.S. Dept of Justice,Investigations and Prosecutions in States Authorizing the

Medical Use of Marijuana (Oct 19, 2009), available athttp://www.justice.gov/opa/documents/medical-

marijuana.pdf.7

7But see James M. Cole, Deputy Attorney General, U.S. Dept ofJustice, Guidance Regarding the Ogden Memo in JurisdictionsSeeking to Authorize Marijuana for Medical Use (June 29, 2011),available at http://www.azdhs.gov/medicalmarijuana/documents/resources/guidance_regarding_medical_marijuana.pdf (OgdenMemorandum was not intended to shield from prosecutionplanned facilities with revenue projections of millions ofdollars and that [p]ersons who are in the business of cultivating,

selling or distributing marijuana . . . are in violation of theControlled Substances Act, regardless of state law).


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ASAs Representational Standing

Finally, I believe that ASA lacks standing to bring thisaction on behalf of its members because ASA has failed toestablish that one of its members has standing to sue in hisown right. Fund Democracy, LLC v. SEC, 278 F.3d 21, 25(D.C. Cir. 2002) (An association only has standing to bringsuit on behalf of its members when[, inter alia,] its memberswould otherwise have standing to sue in their own right . . ..).8

Because I believe that no petitioner possesses Article IIIstanding, I respectfully dissent.9

8 In addition, intervenor Carl Olsen lacks standing. He concedesthat his injury can be redressed only if marijuana is removed fromall CSA schedules, a remedy the petitioners do not seek.Furthermore, Olsen makes distinct arguments from those of thepetitionersfor example, he invokes federalismand 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 mycolleagues are more forgiving than others in allowing exceptions tothe Sierra Club rule, codified in Rule 28(a)(7), it is now apparentthe majority would have the exceptions swallow the Rule. Ignoringour longstanding precedent that arguments may not be made for thefirst 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., UnitedStates v. Southerland, 486 F.3d 1355, 1360 (D.C. Cir. 2007), orduring rebuttal oral argument, see, e.g., Coal. of Battery Recyclers

Assn v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010)they wouldrevise Rule 28(a)(7) to create a reasonable belief/effort mega-exception permitting any party to assert an entirely new standing


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theory not only in a reply brief or during oral argument but evenafter oral argument.

The elephant in the room is that we do not allow a party to assertan entirely new injury (and thus, an entirely new theory of standing)in its reply brief, Coal. for Responsible Regulation, 684 F.3d at147, much less in a supplemental brief. As already noted, in hissupplemental affidavit Krawitz raises a new injury and, thus, a newtheory of standing. Yet in response to this undisputed fact, my

colleagues do not attempt to claim Krawitzs theory of standing isnotnew. Instead, they skirt the issue by noting that DEA did not soargue in its supplemental brief. First and foremost, whether a partyhas established standing is for the courtnot the partiestodecide. See, e.g.,Animal Legal Defense Fund, Inc. v. Espy, 29 F.3d720, 723 n.2 (D.C. Cir. 1994) (Standing . . . is a jurisdictionalissue which cannot be waived or conceded.); cf.Am. LibraryAssn, 401 F.3d at 495 ([W]hether standing is self-evident must bejudged from the perspective of the court[.]). And the majoritysstatement that Rule 28(a)(7) (let alone Sierra Club) ha[s] norelevance absent an objection, see Maj. Op. 11, is whollyunsupported. In any event, DEA didprotest that Krawitz raised a

new standing theory. While DEA did not cite Sierra Club or Rule28(a)(7), it maintained that Krawitz states, for the first time, thathe participates in the Oregon Medical Marijuana Program; andnow claims not that he is denied VA pain treatment in Oregon butthat the VA prohibits its physicians from completing a stateprogram form. Respt Supp. Br. 1.

The majoritys new exception declares that [i]f the partiesreasonably, but mistakenly, believed that the initial filings beforethe court had sufficiently demonstrated standing, the court mayasit did hererequest supplemental affidavits and briefing. Maj. Op.10 (citing Pub. Citizen, Inc., 489 F.3d at 1296-97; Am. Library

Assn, 401 F.3d at 492, 496); see also Maj. Op. 12 (suggesting weshould allow supplemental briefing if parties make a reasonableeffort to satisfy Rule 28(a)(7)). But Public Citizen and American


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Library Association establish no such exception to our Rule. See,e.g., Am. Library Assn, 401 F.3d at 492 (establishing exception ifthe petitioners reasonably [but mistakenly] believed their standing[was] self-evident). Moreover, I do not see how the majoritys new

exception would not apply in virtually every casepresumablyparties do not make unreasonable standing arguments or fail touse reasonable efforts to establish their standing.

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Americans for Safe Access v. DEA

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