Suzanne Sisley, M.d. v. U.s. Drug Enforcement Administration

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
SUZANNE SISLEY, M.D.;
SCOTTSDALE RESEARCH INSTITUTE,
LLC; BATTLEFIELD FOUNDATION,
DBA Field to Healed; LORENZO
SULLIVAN; KENDRICK SPEAGLE;
GARY HESS,
Petitioners,
v.
U.S. DRUG ENFORCEMENT
ADMINISTRATION; MERRICK B.
GARLAND, Attorney General; ANNE
MILGRAM, Administrator, Drug
Enforcement Administration,
Respondents.
No. 20-71433
DEA No.
DEA-427
OPINION
On Petition for Review of an Order of the
Drug Enforcement Agency
Argued and Submitted June 10, 2021
Seattle, Washington
Filed August 30, 2021
Before: William A. Fletcher, Paul J. Watford, and
Daniel P. Collins, Circuit Judges.

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SISLEY V. USDEA 2
Opinion by Judge W. Fletcher;
Concurrence by Judge Watford;
Concurrence by Judge Collins
SUMMARY*
Exhaustion / Controlled Substances Act
The panel dismissed a petition for review of a Drug
Enforcement Agency (“DEA”) letter responding to a request
that the DEA reschedule marijuana in all of its forms under
the Controlled Substances Act (“CSA”).
Stephen Zyszkiewicz, a California state prisoner, joined
by Jeramy Bowers, a medical cannabis patient, submitted a
one-page handwritten petition to the DEA, seeking to
reschedule marijuana. The DEA responded by letter, denying
the request. Petitioners in this case are Dr. Suzanne Sisley,
Scottsdale Research Institute, LLC, Battlefield Foundation,
and three veterans, who filed in this court a petition for
review of the DEA’s response.
The panel held that petitioners had Article III standing.
The panel rejected the government’s contention that
petitioners lacked standing because they only asserted a
generalized grievance. Rather, petitioners contended that
they suffered direct and particularized harms due to the
misclassification of cannabis.
* This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.

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SISLEY V. USDEA 3
The panel held that petitioners failed to exhaust their
administrative remedies with the DEA. Although the CSA
does not, in terms, require exhaustion of administrative
remedies, the panel agreed with the Second Circuit that the
text and structure of the CSA show that Congress sought to
favor administrative decisionmaking that required exhaustion
under the CSA. Petitioners did not seek to join
Zyszkiewicz’s one-page petition or seek to intervene with
respect to his petition to the DEA. In addition, petitioners did
not raise the issue that Zyszkiewicz raised in his petition to
the DEA, but instead raised two different arguments. The
panel concluded that under the circumstances of this case
petitioners had not exhausted their administrative remedies
and had given no convincing reasons to excuse their failure
to exhaust.
Judge Watford concurred. He wrote separately to note
that in an appropriate case, the DEA may be obliged to
initiate a reclassification proceeding for marijuana given the
strength of petitioners’ argument that the agency
misinterpreted the CSA by concluding that marijuana has no
currently accepted medical use in the United States.
Judge Collins concurred in Parts I, II(B), and III of the
majority opinion. He did not join Part II(A), which
concluded that petitioners had Article III standing to
challenge the denial of Zyszkiewicz’s handwritten petition to
the DEA. Given that petitioners’ failure to exhaust
administrative remedies was dispositive here, there was no
need to address petitioners’ Article III standing.

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SISLEY V. USDEA 4
COUNSEL
Matthew Zorn (argued), Yetter Coleman LLP, Houston,
Texas; Shane Pennington (argued), Vicente Sederberg LLP,
New York, New York; for Petitioners.
Daniel Aguilar (argued) and Mark B. Stern, Appellate Staff,
Civil Division, United States Department of Justice,
Washington, D.C., for Respondents.
Erica W. Harris, Susman Godfrey LLP, Houston, Texas, for
Amicus Curiae Iraq and Afghanistan Veterans of America.
Lisa L. Pittman, Coats Rose P.C., Austin, Texas, for Amici
Curiae Rice University’s Baker Institute of Public Policy,
Drug Policy Program, Dr. Kevin Boehnke, and Dr. Daniel
Clauw.
John McKay and Christopher Morley, Davis Wright
Tremaine LLP, Seattle, Washington; Giancarlo Urey, Nicole
S. Phillis, and Heather F. Canner, Davis Wright Tremaine
LLP, Los Angeles, California; for Amici Curiae Lori Walker
PhD, Stephen Defelice MD, Lyle E. Craker PhD, Daniela
Vergara PhD, Christopher J. Hudalla PhD, Rachna Patel MD,
Wendy and Tom Turner, and Maureen Leehey MD.

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SISLEY V. USDEA 5
OPINION
W. FLETCHER, Circuit Judge:
Stephen Zyszkiewicz, joined by Jeramy Bowers, filed a
one-page, handwritten petition to the United States Drug
Enforcement Administration (“DEA”) seeking the
rescheduling of marijuana in all of its forms under the
Controlled Substances Act (“CSA”), 21 U.S.C. § 801 et seq.
The DEA wrote a letter in response, stating that
Zyszkiewicz’s letter was not in the proper format for a
petition but that it welcomed the opportunity to respond to his
concerns. The DEA’s letter gave reasons for having denied
an earlier rescheduling petition filed by Governors Lincoln
Chafee of Rhode Island and Christine Gregoire of
Washington State. Zyszkiewicz treated the DEA’s answer as
a denial of his petition and unsuccessfully sought judicial
review.
Dr. Suzanne Sisley, Scottsdale Research Institute, LLC
(“SRI”), Battlefield Foundation (the non-profit research arm
of SRI), and three veterans (collectively, “Petitioners”) seek
judicial review of the DEA’s response to Zyszkiewicz’s
petition. Petitioners did not seek to intervene in
Zyszkiewicz’s petition before the DEA, nor have they filed a
petition of their own before the DEA. The arguments
Petitioners now seek to raise were not made in Zyszkiewicz’s
petition.
The government challenges Petitioners’ standing and
argues that Petitioners failed to exhaust their claims before
the DEA. We hold that Petitioners satisfy Article III’s
standing requirements, but that they have failed to exhaust
their administrative remedies under the CSA. We therefore

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SISLEY V. USDEA 6
do not reach the merits of Petitioners’ arguments. We
dismiss their petition for review.
I. Background
A. The Controlled Substances Act
The Controlled Substances Act of 1970 places federally
regulated substances into one of five schedules depending on
the substance’s “potential for abuse,” “medical use,” “safety,”
and likelihood of physical or psychological “dependence.”
See 21 U.S.C. § 812(b). Schedule I is the most restrictive
schedule. Marijuana is currently a Schedule I substance. To
merit scheduling in Schedule I, a substance must have “a high
potential for abuse,” “no currently accepted medical use in
treatment in the United States,” and “a lack of accepted safety
for use . . . under medical supervision.” Id. § 812(b)(1)(A),
(B), (C). Schedule II requires, inter alia, that a substance
have “a currently accepted medical use in treatment in the
United States or a currently accepted medical use with severe
restrictions.” Id. § 812(b)(2)(B). Schedules III through V
each require, inter alia, “a currently accepted medical use in
treatment in the United States.” Id. § 812(b)(3)–(5).
The CSA authorizes the Attorney General through
rulemaking proceedings to reclassify drugs by assigning them
to less restrictive schedules, or to remove them from control
entirely. 21 U.S.C. § 811(a). The Attorney General may
initiate rulemaking proceedings “(1) on his own motion, (2) at
the request of the [Department of Health and Human Services
(“HHS”)] Secretary, or (3) on the petition of any interested
party.” Id. The Attorney General has delegated this authority
to the DEA Administrator.

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SISLEY V. USDEA 7
Before initiating proceedings to control, reschedule, or
remove a substance from control, the Attorney General must
request (1) “a scientific and medical evaluation” and (2) a
scheduling recommendation from the HHS Secretary. Id.
§ 811(b). “If control is required by United States obligations
under international treaties, conventions, or protocols in
effect on October 27, 1970, the Attorney General shall issue
an order controlling such drug under the schedule he deems
most appropriate to carry out such obligations, without regard
to the findings required by subsection (a) of [section 811] or
section 812(b) of this title and without regard to the
procedures prescribed by subsections (a) and (b) of [section
811].” Id. § 811(d)(1).
“[A]ny person aggrieved by a final decision of the Attorney
General [under this subchapter] may obtain review of the
decision in the United States Court of Appeals for the District
of Columbia or for the circuit in which his principal place of
business is located upon petition filed with the court and
delivered to the Attorney General within thirty days after
notice of the decision.” Id. § 877.
B. Zyszkiewicz’s Petition to the DEA
Stephen Zyszkiewicz, a prisoner in Soledad State Prison
in California, joined by Jeramy Bowers, a “medical cannabis
epilepsy patient,” submitted a one-page, handwritten petition
to the DEA, dated January 3, 2020, seeking to reschedule
marijuana or to remove it from the schedules. Zyszkiewicz
stated in his petition that he was in prison after a conviction
for selling cannabis. Zyszkiewicz’s petition read, in relevant
part:

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I hereby petition the US AG, DOJ, ONDCP,
DEA and Congress to remove or reschedule
cannabis (marijuana) in all its forms . . . .
Petitioner finds the current situation of
cannabis in Schedule I completely untenable.
Half the states allow for medical use and the
FDA allows CBD and THC pharmaceuticals
as well as IND Compassionate Use.
Under the Constitution and 21 USCS 811, 812
the continued war on drugs (cannabis) must
be corrected by removing or rescheduling
cannabis.
The DEA responded by letter to Zyszkiewicz’s petition on
April 22, 2020. The letter stated:
. . . Although your letter is not in the proper
format of a petition as outlined in Section 811
of the Federal Criminal Code, DEA
appreciates the opportunity to address your
concerns.
On August 12, 2016, the Federal Register
addressed similar concerns from a petition
submitted on November 30, 2011, from the
Honorable Lincoln D. Chafee and the
Honorable Christine O. Gregoire. The above
[governors] petitioned DEA to initiate
rulemaking proceedings under the
rescheduling provisions of the [CSA].
Specifically, they petitioned DEA to have
marijuana and “related items” removed from

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SISLEY V. USDEA 9
schedule I of the CSA and rescheduled as
medical cannabis in schedule II. They
requested that DEA remove marijuana and
related items from schedule I based on their
assertion that: (1) Cannabis has accepted
medical use in the United States; (2) Cannabis
is safe for use under medical supervision;
(3) Cannabis for medical purposes has a
relatively low potential for abuse, especially
in comparison with other schedule II drugs.
In accordance with the CSA rescheduling
provisions, after gathering the necessary data,
DEA requested a scientific and medical
evaluation and scheduling recommendation
from [HHS]. HHS concluded that marijuana
has a high potential for abuse, has no accepted
medical use in the United States, and lacks an
acceptable level of safety for use even under
medical supervision. Therefore, HHS
recommended that marijuana remain in
schedule I. The scientific and medical
evaluation and scheduling recommendation
that HHS submitted to DEA is enclosed with
this letter.
Based on HHS’s evaluation and all other
relevant data, DEA has concluded that there is
no substantial evidence that marijuana should
be removed from schedule I. A document
prepared by DEA addressing these materials
in detail is also enclosed. In short, marijuana
continues to meet the criteria for schedule I
control under the CSA.

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SISLEY V. USDEA 10
In sum, DEA recognizes the possibility that
drugs containing marijuana or its derivatives
might, in the future, be proven to be safe and
effective for the treatment of certain
conditions and thus approved [] by the United
States Food and Drug Administration for
marketing. Until then, we will continue to
identify opportunities to assist researchers in
this area while never losing sight of the need
to protect the public.
Zyszkiewicz petitioned for mandamus in the District
Court for the District of Columbia. The district court denied
mandamus, and the D.C. Circuit affirmed. See Zyszkiewicz
v. Barr, No. CV 20-1599, 2020 WL 3572908 (D.D.C. June
30, 2020), aff’d, 831 F. App’x. 519 (D.C. Cir. 2020).
Zyszkiewicz also petitioned for review directly to the D.C.
Circuit, which denied the petition as untimely. Order,
Zyszkiewicz v. Barr, No. 20-1308 (D.C. Cir. Jan. 25, 2021).
Petitioners did not seek to join or to intervene in either of
Zyszkiewicz’s judicial petitions.
C. The Present Petition
On May 21, 2020, Petitioners filed in this court a petition
for review of the DEA’s response to Zyszkiewicz’s petition.
Petitioners argue (1) that the DEA’s interpretation of “no
currently accepted medical use” under 21 U.S.C.
§ 812(b)(1)(B) with respect to cannabis is arbitrary and
capricious or otherwise contrary to law; and (2) that
21 U.S.C. § 811(d)(1) constitutes an unconstitutional
delegation of legislative power. Neither of these arguments
was made in Zyszkiewicz’s petition.

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SISLEY V. USDEA 11
The government moved to dismiss for failure to exhaust
administrative remedies. A motions panel of this court
denied the government’s motion without prejudice to
presenting the argument in its brief to the merits panel.
II. Discussion
The government makes two preliminary arguments:
(1) that Petitioners lack standing under Article III and (2) that
Petitioners have failed to exhaust their administrative
remedies under the CSA. We conclude that Petitioners have
Article III standing, but that they have failed to exhaust their
administrative remedies. We therefore dismiss the petition
without reaching the merits.
A. Article III Standing
Article III standing requires that a plaintiff demonstrate
(1) an “injury in fact,” (2) “a causal connection between the
injury and the conduct complained of,” and (3) a likelihood
“that the injury will be redressed by a favorable decision.”
Lujan v. Defs. of Wildlife, 504 U.S. 555, 560–61 (1992)
(quotations omitted). “An injury in fact is an invasion of a
legally protected interest that is concrete and particularized
and actual or imminent, not conjectural or hypothetical.”
Novak v. United States, 795 F.3d 1012, 1018 (9th Cir. 2015)
(quotation marks and alteration omitted) (citing Lujan,
504 U.S. at 560). “Because a generalized grievance is not a
particularized injury, a suit alleging only generalized
grievances fails for lack of standing.” Id. “The fact that a
harm is widely shared does not necessarily render it a
generalized grievance.” Ecological Rts. Found. v. Pac. Gas
& Elec. Co., 874 F.3d 1083, 1093 (9th Cir. 2017) (alteration
omitted) (quoting Novak, 795 F.3d at 1018). “Rather, a

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SISLEY V. USDEA 12
grievance too ‘generalized’ for standing purposes is one
characterized by its ‘abstract and indefinite nature—for
example, harm to the common concern for obedience to
law.’” Id. (quoting Novak, 795 F.3d at 1018).
The government argues that Petitioners lack Article III
standing because they assert only a generalized grievance.
Characterizing Petitioners’ challenge as based on an asserted
interest in the Executive Branch following the law, the
government argues that Petitioners lack standing because that
interest is common to all who may wish to reschedule
controlled substances. The government may be right that
such an interest is too generalized to warrant Article III
standing, but Petitioners do not assert only a generalized
harm. Rather, they contend they suffer direct and
particularized harms due to the misclassification of cannabis.
Dr. Sisley and her associated institutions contend that the
misclassification impedes their research efforts, and the
veterans contend that it forecloses their access to medical
treatment with cannabis through the Department of Veterans
Affairs. The government also argues Petitioners’ claims rest
“on the legal rights or interests of third parties.” While it is
undoubtedly true that the interests of third parties would be
affected by a rescheduling of cannabis, this fact does not
diminish Petitioners’ direct and particularized interest in
rescheduling. See Americans for Safe Access v. DEA,
706 F.3d 438, 445–49 (D.C. Cir. 2013).
We therefore conclude that Petitioners have Article III
standing.

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SISLEY V. USDEA 13
B. Failure to Exhaust
“The doctrine of exhaustion of administrative remedies is
well established in the jurisprudence of administrative law.”
Woodford v. Ngo, 548 U.S. 81, 88 (2006) (quoting McKart v.
United States, 395 U.S. 185, 193 (1969)); see Myers v.
Bethlehem Shipbuilding Corp., 303 U.S. 41, 50–51 (1938).
“[P]roper exhaustion of administrative remedies . . . means
using all steps that the agency holds out, and doing so
properly (so that the agency addresses the issues on the
merits).” Woodford, 548 U.S. at 90 (quotations and emphasis
omitted). “As a general rule . . . courts should not topple over
administrative decisions unless the administrative body not
only has erred, but has erred against objection made at the
time appropriate under its practice.” Id. (alteration adopted
and emphasis omitted) (quoting United States v. L.A. Tucker
Truck Lines, Inc., 344 U.S. 33, 37 (1952)).
Where Congress has not clearly required exhaustion,
courts may impose it as an act of “sound judicial discretion.”
McCarthy v. Madigan, 503 U.S. 140, 144 (1992). Our
discretion requires “appropriate deference to Congress’ power
to prescribe the basic procedural scheme under which a claim
may be heard in a federal court.” Id. Any “fashioning of
exhaustion principles” must be made “in a manner consistent
with congressional intent and any applicable statutory
scheme.” Id.
The CSA does not, in terms, require exhaustion of
administrative remedies. However, we agree with the Second
Circuit that the text and structure of the CSA “show[] that
Congress sought to favor administrative decisionmaking” and
that requiring exhaustion under the CSA “is consistent with

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SISLEY V. USDEA 14
congressional intent.” Washington v. Barr, 925 F.3d 109,
116, 118 (2d Cir. 2019). As stated by the Second Circuit:
The exhaustion requirement under the CSA is
. . . prudential, not jurisdictional. It is not
mandated by the statute. Rather, it is a
judicially-created administrative rule, applied
by courts in their discretion.
Id. at 119.
Section 811(a) tasks the Attorney General with
scheduling, rescheduling, or removing from the schedules
drugs or other substances by rulemaking. As we noted above,
such proceedings “may be initiated by the Attorney General
(1) on his own motion, (2) at the request of the [HHS]
Secretary, or (3) on the petition of any interested party.”
21 U.S.C. § 811(a) (emphasis added). Congress thus
expressly authorized individuals to petition the DEA—not the
courts directly—to schedule, reschedule, or remove a
substance. The CSA prescribes steps for the Attorney
General to follow before initiating proceedings, § 811(b), and
details factors to consider in so doing, § 811(c). In § 877, the
CSA provides for judicial review of final agency action, not
judicial decisionmaking in the first instance. To require
interested individuals to petition the DEA before seeking
judicial review is consistent with—indeed almost demanded
by—this carefully established statutory process. See United
States v. Cal. Care Corp., 709 F.2d 1241, 1248–49 (9th Cir.
1983) (requiring exhaustion where to do otherwise “would
encourage the deliberate bypass of the administrative
scheme”).

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SISLEY V. USDEA 15
In the case before us, Petitioners ask us either to conclude
that their administrative remedies have been exhausted by
Zyszkiewicz’s one-page petition or to excuse their failure to
exhaust. The government has not argued to us that the DEA’s
response to Zyszkiewicz’s petition was not a denial of the
petition, or that its response was not final agency action
within the meaning of the Administrative Procedure Act
(“APA”). See 5 U.S.C. § 704. In light of the government’s
failure to make such arguments, we are willing to assume for
present purposes that the DEA’s response to Zyszkiewicz’s
petition was a denial of that petition and was final agency
action under the APA, even though the DEA characterized its
action as only an “opportunity to address [Zyszkiewicz’s]
concerns” rather than as a denial of the petition.
Petitioners did not seek to join Zyszkiewicz’s one-page
petition or seek to intervene with respect to his petition to the
DEA. Zyszkiewicz advanced only one argument in his
petition to the DEA. Petitioners ignore that argument;
instead, they advance two different arguments. Petitioners
were asked during oral argument before our court why they
did not file their own petition with the DEA and then seek
review if the DEA denied their petition. They responded that
that process would take too long, even though Zyszkiewicz’s
petition was filed in January 2020, and the DEA responded to
that petition in April 2020. Oral Argument at 31:54–33:19,
Sisley v. DEA, No. 20-71433 (9th Cir. June 10, 2021).
Recognizing that administrative exhaustion under the
CSA is judge-made law, “applied by courts in their
discretion,” Washington, 925 F.3d at 119, we hold, under the
circumstances of this case, that Petitioners have not exhausted

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SISLEY V. USDEA 16
their administrative remedies and have given no convincing
reason to excuse their failure to exhaust. We are well aware
that reclassification of cannabis is a matter of ongoing active
debate. However, this is not an appropriate case in which to
consider that issue.
III. Conclusion
Petitioners seek to bypass the normal administrative
process by seeking review of the DEA’s response to
Zyszkiewicz’s petition and then seeking to make arguments
never advanced by Zyszkiewicz. Nothing prevents
Petitioners from filing a petition of their own before the DEA,
raising the arguments they seek to raise before us now.
Because Petitioners have failed to exhaust their
administrative remedies with the DEA, their petition for
judicial review is
DISMISSED.
WATFORD, Circuit Judge, concurring:
I agree that the petitioners in this case failed to exhaust
their administrative remedies and therefore join the court’s
opinion dismissing their petition for review. I write
separately to note that, in an appropriate case, the Drug
Enforcement Administration may well be obliged to initiate
a reclassification proceeding for marijuana, given the strength
of petitioners’ arguments that the agency has misinterpreted
the controlling statute by concluding that marijuana “has no

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SISLEY V. USDEA 17
currently accepted medical use in treatment in the United
States.” 21 U.S.C. § 812(b)(1)(B).
COLLINS, Circuit Judge, concurring in part:
I concur in Parts I, II(B), and III of the majority opinion,
which provide fully sufficient grounds for dismissing the
petition in this case. I do not join Part II(A), which concludes
that Petitioners have Article III standing to challenge the
denial of Zyszkiewicz’s handwritten petition to the U.S. Drug
Enforcement Administration (“DEA”). I am skeptical that
the particular injuries that Petitioners assert are “fairly
traceable” to that decision of the DEA, see Lujan v.
Defenders of Wildlife, 504 U.S. 555, 560 (1992) (simplified),
but I do not think that it is necessary to decide the point.
Because exhaustion of administrative remedies “does not
entail any assumption by the court of substantive ‘law-
declaring power,’” it raises the sort of threshold, non-merits
issue that we may resolve first, without having to address
subject matter jurisdiction. See Sinochem Int’l Co. v. Malay.
Int’l Shipping Corp., 549 U.S. 422, 433 (2007) (citation
omitted); see also id. at 431 (noting that “a federal court has
leeway ‘to choose among threshold grounds for denying
audience to a case on the merits’” (citation omitted)).1 And
1 See also Sarei v. Rio Tinto, PLC, 550 F.3d 822, 824 & n.1 (9th Cir.
2008) (en banc) (plurality) (concluding that, under Sinochem, it was
appropriate to direct the district court to consider whether to require
exhaustion of local remedies in a suit under the Alien Tort Statute,
28 U.S.C. § 1350, despite the presence of unresolved jurisdictional
issues); id. at 833–37 (Bea, J., concurring) (agreeing with the plurality’s
remand to consider exhaustion, while differing as to the source of the
exhaustion requirement); id. at 840 & n.1 (Kleinfeld, J., concurring)

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SISLEY V. USDEA 18
given that Petitioners’ failure to exhaust administrative
remedies is dispositive here, we have no need to address
Petitioners’ Article III standing, and I do not do so.2
(agreeing that, under Sinochem, a remand to consider exhaustion was
appropriate, despite jurisdictional issues); id. at 837–38 (Ikuta, J.,
dissenting) (agreeing that, under Sinochem, “there is no mandatory
sequencing of non-merits grounds for disposing of a case,” but concluding
that, under the circumstances of that case, the jurisdictional issue should
be resolved first and was dispositive); Valenzuela v. Silversmith, 699 F.3d
1199, 1205 (10th Cir. 2012) (whether appellant “failed to exhaust tribal
court remedies is . . . a threshold, nonmerits issue” that may be decided
without resolving subject matter jurisdiction).
2 I likewise express no view whatsoever on the merits of the claims.

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