DISTRICT COURT, CITY AND COUNTY OF DENVER,

STATE OF COLORADO
City and County Building
1437 Bannock Street
Denver, CO 80202
720-865-8301
_________________________________________________
Plaintiffs: CURTIS BEAN, LARISA BOLIVAR,
STEPHEN OTERO, MATTHEW KAHL, and ZACH
PHILLIPS
v.
Defendant: COLORADO DEPARTMENT OF PUBLIC
HEALTH AND THE ENVIRONMENT, and
COLORADO BOARD OF HEALTH

COURT USE ONLY

Attorneys for Plaintiffs:

Case Number: 15CV32969

Robert T. Hoban, #33151

C. Adam Foster, #35969
Jean E. S. Gonnell, #44623
Hoban & Feola, LLC
730 17th Street, Suite 420
Denver, Colorado 80202
Telephone: 303-674-7000

PLAINTIFFS OPENING BRIEF

The Plaintiffs, by and through their attorneys, Hoban & Feola, LLC, hereby submit their
Opening Brief, respectfully stating as follows:
INTRODUCTION
Each of the individual Plaintiffs suffers from Post Traumatic Stress Disorder (PTSD)
and uses medical marijuana to control the symptoms of PTSD. Exhibit A; Transcript
(Transcript); pgs. 33-36; 54-56; 68-70.

The individual Plaintiffs access to appropriate

medicinal strains of marijuana has been severely impeded by the Colorado Board of Healths
(the Board) refusal to recognize PTSD as an appropriate condition for medical marijuana

recommendations. Transcript; pgs. 46-50. This is because many of the most effective strains of
medical marijuana for treating PTSD are only available to registered medical marijuana patients,
and the majority of the most knowledgeable medical marijuana caregivers will only treat
registered patients. Transcript; pgs. 46-50.
Additionally, to the limited extent that the most effective strains of medical marijuana for
treating PTSD are available through the recreational marijuana market, such strains are
significantly more expensive, which imposes severe financial hardship on Plaintiffs and similarly
situated individuals suffering from PTSD. Transcript; pgs. 39-40. All of these factors present
significant obstacles to Plaintiffs and other individuals suffering from PTSD who wish to obtain
a medical marijuana recommendation from a licensed healthcare provider to treat their PTSD
symptoms.
The Defendants arbitrary and capricious decision to deny the Petition based upon the
purported lack of medical evidence creates a Catch-22 by impeding research to further
quantify the benefits and side-effects of using medical marijuana to treat PTSD and hampering
efforts to identify and refine the most effective strains of medical marijuana for treating PTSD.
Moreover, the Defendant has arbitrarily denied physicians the opportunity to use their clinical
judgment to prescribe the medicine that will most effectively treat their patients PTSD
symptoms.
5 CCR 1006-2, Regulation 6(D) provides that the department shall accept physician or
patient Petitions to add debilitating medical conditions to the list provided in paragraphs A and
B1 of this regulation, and it provides a procedural mechanism for the addition of debilitating

1

Paragraphs A and B of 5 CCR 1006-2 state: A. Debilitating medical conditions are defined as
cancer, glaucoma, and infection with or positive status for human immunodeficiency virus.
Patients undergoing treatment for such condition are defined as having a debilitating medical

conditions to the approved list. Such a Petition was filed with the CDPHE. Agency Record; pg.
129, 469.
Pursuant to C.R.S. 24-4-103, the Board conducted a public rule making hearing on July
15, 2015 to consider modifying 5 CCR 1006-2 to add PTSD as a recognized debilitating
condition. But despite appropriate and sufficient research-based evidence that medicinal
cannabis is in fact efficacious for the treatment of PTSD, the Board denied the same and refused
to amend the Rules to include this condition.
As set forth in the Plaintiffs August 19, 2015 Complaint for Judicial Review Pursuant to
C.R.S. 24-4-106, the Defendant acted in an arbitrary and capricious manner in Boards July 15,
2015 decision denying a Petition to add PTSD as an acceptable condition for medical marijuana
recommendations (the Rulemaking Action).
The following states have approved PTSD as a qualifying condition for their medical
marijuana

programs:

Arizona,

California,

Connecticut,

Delaware,

Maine,

Maryland,

Massachusetts, Michigan, Nevada, New Mexico, and Oregon. Transcript; pg. 47; Exhibit B (Dr.
Sisleys Slideshow Presentation); pg. 18. The territory of Guam and Washington D.C. also
permit use of medical marijuana to treat PTSD symptoms. Many of these states relied on the
very same information provided by Dr. Sisley at the July 15, 2015 hearing in doing so.
Transcript; pg. 47; Exhibit B (Dr. Sisleys Slideshow Presentation); pg. 18.

condition. B- Debilitating medical condition also includes a chronic or debilitating disease or

medical condition other than HIV infection, cancer or glaucoma; or treat for such conditions,
which produces for a specific patient one or more of the following, and for which, in the
professional opinion of the patients physician, such condition or conditions may reasonably be
alleviated by the medial use of marijuana: cachexia; severe pain; severe nausea; seizures,
including those that are characteristic of epilepsy; or persistent muscle spasms, including those
that are characteristic of multiple sclerosis.

Arizona recognized medical marijuana as a legitimate treatment for PTSD following the
decision in In re Arizona Cannabis Nurses Assn., 2014A-MMR-0;-DHS (AZ Office of Admin.
Hearings, June 4, 2014). Agency Record; pgs. 550-577, Exhibit C (Dr. Sisleys Affidavit); pg.4.
In that case, Administrative Law Judge Thomas Sheddon held that testimony demonstrating that
patients suffering from PTSD received a palliative effect from medical marijuanacoupled with
the New Mexico study referenced above and testimony that prescribing medical marijuana was
consistent with clinicians use of other off-label drugs to treat PTSD--was sufficient to meet
the Appellants burden of proof to list PTSD as a qualifying condition.
Because the Board failed to properly consider appropriate evidence, limited the public
testimony in an arbitrary and capricious fashion, and imposed an unattainable and arbitrary
standard for the addition of PTSD as a qualifying debilitating condition, Plaintiffs respectfully
ask this Court to hold the Board decision to be unlawful and set aside the agency action; compel
the agency action to be taken which has been unlawfully withheld or unduly delayed; and/or
remand the case for further proceedings.
ISSUES PRESENTED FOR REVIEW
Issue 1: Was the Colorado Board of Healths (the Board) decision to deny the Petition
to add Post Traumatic Stress Disorder (PTSD) as a qualifying condition for medical marijuana
recommendations inconsistent with Article XVIII 14 of the Constitution of the State of
Colorado, which expressly contemplates the addition of further qualifying debilitating
conditions?
Issue 2: Whether the Board failed to comply with the Colorado Department of Public
Health and Environments (CPDHE) Regulation 6(D) procedure that applies when patients or
physicians petition the Board to add debilitating medical conditions to the list?

Issue 3: Did the Board abuse its discretion when it limited psychiatrist and PTSD expert
Suzanne Sisley MDs testimony at the hearing, but then denied the Petition for lack of sufficient
scientific evidence?
Issue 4: Did the Board violate C.R.S. 25-1.5-106, which imposes a duty on CDPHE to
ensure that patients suffering from legitimate debilitating medical conditions are able to safely
gain access to medical marijuana?
STANDARD OF REVIEW
Importantly, the standard of review for quasi-legislative agency rulemaking action set out
in C.R.S. 24-4-106(7) is both broader and less deferential to the government than the abuse of
discretion standard for review of quasi-judicial actions set forth in C.R.C.P. 106(a)(4). Pursuant
to C.R.S. 24-4-106(7):
If [the Court] finds that the agency action is arbitrary or capricious, a denial of
statutory right, contrary to constitutional right, power, privilege, or immunity, in
excess of statutory jurisdiction, authority, purposes, or limitations, not in accord
with the procedures or procedural limitations of this article or as otherwise
required by law, an abuse or clearly unwarranted exercise of discretion, based
upon findings of fact that are clearly erroneous on the whole record, unsupported
by substantial evidence when the record is considered as a whole, or otherwise
contrary to law, then the court shall hold unlawful and set aside the agency action
and shall restrain the enforcement of the order or rule under review, compel any
agency action to be taken which has been unlawfully withheld or unduly delayed,
remand the case for further proceedings, and afford such other relief as may be
appropriate. In making the foregoing determinations, the court shall review the
whole record or such portions thereof as may be cited by any party. In all cases
under review, the court shall determine all questions of law and interpret the
statutory and constitutional provisions involved and shall apply such
interpretation to the facts duly found or established.
See also Colorado Dept. of Social Services v. Davis, 796 P.2d 494, 495 (Colo. App. 1990) (a
Court is required to set aside an agency action if the action is unsupported by the evidence or
otherwise contrary to the law.). Whether there is substantial evidence to support an agency

decision is a question of law. Ace West Trucking, Inc. v. Public Utilities Comn of State of Colo.,
788 P.2d 755, 762 (Colo. 1990).
In determining whether an agencys decision should be set aside, the court must
determine whether a reasonable person, considering all of the evidence in the record, would
fairly and honestly be compelled to reach a different conclusion. Ramseyer v. Colo. Dept. of Soc.
Servs., 895 P.2d 1188 (Colo. App. 1995). A reviewing court reviews the agencys conclusions of
law de novo. City of Longmont v. Henry-Hobbs, 50 P.3d 906 (Colo. 2002).
Ultimately, the burden is on the challenging party to establish invalidity of rules
adopted pursuant to a statutory rule-making proceeding by demonstrating that the
rule-making body acted in an unconstitutional manner, exceeded its statutory
authority, or otherwise acted in a manner contrary to statutory requirements.
Brown v. Colo. Ltd. Gaming Control Comm'n, 1 P.3d 175 (Colo. App. 1999).
In determining whether an administrative agency's decision is arbitrary or
capricious, the court must determine whether a reasonable person, considering all
of the evidence in the record, would fairly and honestly be compelled to reach a
different conclusion. If not, no abuse of discretion has occurred and the agency
decision must be upheld.
Ramseyer v. Colo. Dept. of Soc. Servs., 895 P.2d 1188 (Colo. App. 1995).
ARGUMENT
Issue 1: The Boards Actions Were Inconsistent With Article XVIII 14 of the State
Constitution
In November of 2000, the voters approved Amendment 20 to the Constitution of the State
of Colorado, which is now codified as Article XVIII 14. Article XVIII 14 provides that
medical use of marijuana is legal for those suffering from debilitating medical conditions and
provides legal protection for caregivers, individuals that provide medical marijuana to authorized
patients.
Article XVIII 14(1)(a) defines debilitating medical condition as:

(I) Cancer, glaucoma, positive status for human immunodeficiency virus, or

acquired immune deficiency syndrome, or treatment for such conditions;
(II) A chronic or debilitating disease or medical condition, or treatment for such
conditions, which produces, for a specific patient, one or more of the following,
and for which, in the professional opinion of the patients physician, such
condition or conditions reasonably may be alleviated by the medical use of
marijuana: cachexia; severe pain; severe nausea; seizures, including those that are
characteristic of epilepsy; or persistent muscle spasms, including those that are
characteristic of multiple sclerosis; or
(III) Any other medical condition, or treatment for such condition, approved by
the state health agency, pursuant to its rule making authority or its approval of
any Petition submitted by a patient or physician as provided in this section.
Constitution of the State of Colorado, Article XVIII 14(a) (emphasis supplied).
Thus, the state Constitution expressly contemplates the addition of further debilitating
conditions that qualify under the medical marijuana program. The Governor has designated the
CDPHE as the state agency responsible for administering the medical marijuana program. C.R.S.
18-18-406.3(d).

C.R.S. 25-1.5-106 sets forth the powers and duties of the CDPHE to

administer this constitutionally authorized medical marijuana program, including the duty, to
ensure that patients suffering from legitimate debilitating medical conditions are able to safely
gain access to medical marijuana C.R.S. 25-1.5-106(1)(a).
The Defendant has failed in their duty to ensure that PTSD patients have reasonable
access to medical marijuana. The CDPHEs rules governing medical marijuana are set forth at 5
CCR. 1006-2. Per 5 CCR 1006-2, Regulation 6(A), [d]ebilitating medical conditions are defined
as cancer, glaucoma, and infection with or positive status for human immunodeficiency virus.
Patients undergoing treatment for such conditions are defined as having a debilitating medical
condition.
In addition, [d]ebilitating medical condition(s) alsoincludea chronic or debilitating
disease or medical condition other than HIV infection, cancer or glaucoma; or treatment for such

conditions, which produces for a specific patient one or more of the following, and for which, in
the professional opinion of the patients physician, such condition or conditions may reasonably
be alleviated by the medical use of marijuana: cachexia; severe pain; severe nausea; seizures,
including those that are characteristic of epilepsy; or persistent muscle spasms, including those
that are characteristic of multiple sclerosis. 5 CCR 1006-2, Regulation 6(B).
5 CCR. 1006-2, Regulation 6(D) provides a procedural mechanism for patients or
physicians to Petition the Board to add debilitating medical conditions to the approved list. Upon
receipt of such a Petition for addition, the CDPHE Executive Director shall review the
information submitted, and, shall also conduct a search of the medical literature for peerreviewed published literature of randomized controlled trials or well-designed observational
studies in humans concerning the use of marijuana for the condition that is the subject of the
petition Regulation 6(D)(1)(emphasis supplied). Such a Petition may be denied without
hearing in a set of circumstances where, effectively, there is no scientific support for the addition
of the proposed debilitating condition. 5 CCR 1006-2, Regulation 6(D)(2). However, here,
substantial scientific evidence does exist, and the Executive Director noted the same. Hearing
Transcript; pgs. 9-12; Exhibit B; pgs. 7-17; 19-31, Agency Record; pgs. 85-124, 133-229, 232316, 339-343, 354-364; 388-396, 449-454, 485-492, 599-612, 625-629.
The Regulations include preliminary review of the proposed additional debilitating
condition by the Medical Marijuana Scientific Advisory Council (MMSAC), which shall
review the petition information presented to the department and any further medical research
related to the condition requested, and make recommendations to the executive director, or his or
her designee, regarding the petition. 5 CCR 1006-2, Regulation 6(D)(3)(c).

At the April 10, 2015 hearing, MMSAC did in fact review the literature, and was
presented with a package of materials, including but not limited to the attached slide
presentation, Exhibit B, which expressly sets forth the scientific literature and scientific bases
for the treatment of PTSD with medicinal cannabis.2
The MMSAC considered materials detailing the benefits of medical marijuana treatments
for PTSD, which included research conducted between 2009 and 2011 in New Mexico, the first
state to authorize treating PTSD with medical marijuana. Exhibit A; pgs. 101-103; Exhibit B;
pgs. 30-32; Exhibit C; pg. 3 12-13. Research provided by Dr. Sisley reported a 75 percent
decrease in three major PTSD symptoms in patients, utilizing the VA-approved Clinically
Administered PTSD Scale (CAPS) method, detailing the presence of PTSD experiences and
the patients responses to these PTSD experiences. See George Greer, Charles S. Grob, Adam L.
Halberstadt, PTSD Symptom Reports of Patients Evaluated for the New Mexico Medical
Cannabis Program, Journal of Psychoactive Drugs, 2014; 46 (1). Agency Record; pgs. 624-629
Exhibit C; pg. 3 12-13. A second study was also discussed by Dr. Sisley which concluded that
while further research into cannabinoid treatment effects on PTSD symptoms are required, the

2

Request for Supplementation of Record: After a complete review of the lengthy record in
this matter, it became apparent that the materials presented to the MMSAC, including but not
limited to Exhibit A, attached hereto, were not presented to the Board. Yet these materials
demonstrate the unequivocal presence of scientific literature and evidence demonstrating that
medicinal cannabis can be effective for the treatment of PTSD. Because these materials were not
included as part of the record, Plaintiffs hereby expressly request that the Court consider the
same and/or supplement the record accordingly, because [a]s to alleged errors, omissions, and
irregularities in the agency record, evidence may be taken independently by the court. C.R.S.
24-4-106(6). In every case of agency action, the record, unless otherwise stipulated by the
parties, shall include the original or certified copies of all pleadings, applications, evidence,
exhibits, and other papers presented to or considered by the agency, rulings upon exceptions, and
the decision, findings, and action of the agency. C.R.S. 24-4-106(6)(emphasis added). And
this request is both timely and proper because of there are no time limitations relating to
objecting to or supplementing the record designated. Harris v. District Court, 655 P.2d 398
(Colo. 1982).

evaluated evidence indicates that substantial numbers of military veterans with PTSD use
cannabis or derivative products to control PTSD symptoms, which some patients reporting
benefits in terms of reduced anxiety and insomnia and improved coping ability. Use and Effects
of Cannabinoids in military veterans with Post Traumatic Stress Disorder, Betthauser K, et al.
Am J. Health Syst. Pharm, 2015. Exhibit C; pg. 3 13.
Pursuant to C.R.S. 24-4-103, the Board conducted a public rule making hearing on July
15, 2015 to consider modifying 5 CCR 1006-2 to add PTSD as a recognized debilitating
condition. See Exhibit A, Transcript. As explained herein, the Board was not presented with
this scientific information.
The proposed rule was developed by the Center for Health and Environmental Data, and
the Disease Control and Environmental Epidemiology Division of the CDPHE pursuant to
Colorado Constitution, Article XVIII, Section 14, and C.R.S. 25-1.5-106 and 106.5. In
scheduling the July 15, 2015 hearing, the Board expressly solicited public input including written
and live testimony and comments. Agency Record; pg. 19. The proposed measure came with
strong support and an express recommendation for approval of the Petition from the state's
MMSAC pursuant to 5 CCR 1006-2, Regulation 6(D)(3), which included the approval and
recommendation of CDPHE Executive Director and Chief Medical Officer Dr. Larry Wolk.
More than 50 members of the public presented testimony at the July 15, 2015 hearing, and only
two individuals, without scientific data, testified against the addition of PTSD to the qualifying
list.
Despite the MMSACs and Dr. Wolks recommendation and support, the Board denied
the Petition following the July 15, 2015 hearing by a vote of six to two against, citing a lack of
sufficient scientific evidence. Exhibit A; pg. 120.

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The Board arbitrarily denied adding PTSD to the list of debilitating conditions due to lack
of a randomized, blind study regardless of the plethora of information and study information
provided by the MMSAC and by the public. Agency Record; 000076-000804. The Board denied
the Petition in part because the addition of PTSD was not supported by a randomized controlled
study. But this establishes an arbitrary and unattainable standard because the federal government
has refused to allow the grant-approved work of Dr. Sisley and Marcel O. Bonn-Miller to move
forward. Thus, the Board made a decision based upon a standard that cannot currently be
attained, leaving PTSD patients to suffer in the meantime.
Fundamentally, the Boards failure to consider appropriate evidence, such as the evidence
considered by the MMSAC, constitutes error and merits reversal and/or remand. Platinum
Props. Corp. v. Bd. of Assess. App., 738 P.2d 34 (Colo. App. 1987) (Abuse of discretion by
Board of Assessment appeals exists where Board failed to consider evidence of value of similar
properties in other counties in Colorado and other states for purposes of property tax
assessment.); Sonnenberg & Sons v. Bd. of Assess. App., 768 P.2d 748 (Colo. App. 1988).
Clearly, the Plaintiffs are prejudiced by the failure of the Board to consider this
information, as it supports the notion that PTSD can be treated at least in part by the use of
medicinal cannabis. The Boards failure to allow this debilitating condition to be added to the
list of qualifying conditions prevents the Plaintiffs from obtaining the relief they seek and need
to treat their range of PTSD-related maladies. This prejudice, combined with the blatant refusal
to consider the information presented to the MMSAC and Dr. Wolk, merits remand and/or
reversal. Rags Over Arkansas River, Inc. v. Colo. Parks & Wildlife Bd., 360 P.3d 186, 191
(Colo. App. 2015) (agency's failure to comply with its own regulations constitutes arbitrary and

11

capricious conduct; however, any impropriety in the administrative process will not require
reversal unless a plaintiff can demonstrate prejudice).
Issue 2: The Boards Failed to Comply with the CDPHEs Regulation 6(D) Procedure for
Petitions to Add a Debilitating Medical Condition
CCR 1006-2 Regulation 6(D)(2) states, in pertinent part:
Department denial of Petitions. The department shall deny a petition to add a
debilitating medical condition within (180) days of receipt of such petition
without any hearing of the board in all of the following circumstances:
If there are no peer-reviewed published studies of randomized controlled studies
nor well-designed observational studies showing efficacy in humans for use of
medical marijuana for the condition that is subject of the petition;
If there are peer-reviewed published studies of randomized controlled trials or
well-designed observational studies showing efficacy in humans for the condition
that is the subject of the petition, and if there are studies that show harm, other
than harm associated with smoking such as obstructive lung disease or lung
cancer, and there are alternative, conventional treatments available for the
condition
As put forth in the minutes for Wednesday, July 5, 2015, Dr. VanDyke noted that the
Petition to the CDPHE was received on January 27, 2015. He further stated that on April 10,
2015, the Petition was presented to the MMSAC, at which point MMSAC recommended PTSD
be added to the list of debilitating conditions. Agency Record; pg. 4.
During Dr. Vandykes testimony to the Board he stated that the Board of Health may
deny any Petition to add a debilitating medical condition if (1) there are no peer-reviewed
published studies of randomized controlled studies or well-designed observational studies
showing efficacy in humans as the first criteria; or (2) there are studies that show harm and there
are alternative conventional treatments available for the condition. Exhibit A, pg. 9-10.
But under the Regulation the Board should have denied the Petition without a hearing, if
there were in fact no peer-reviewed studies or there are studies that show harm. Here, there were
in fact appropriate studies, as Dr. VanDyke admitted. Further, said studies were discussed at

12

length at the MMSAC hearing, which ultimately led to the Public hearing at issue in this matter.
Exhibit A, pg. 10. In other words, if in fact there were no appropriate studies, the Board would
have had no reason to hear testimony, as 5 1006-2(2); Regulation 6, clearly states the Board
shall deny a petition in the instance there is no appropriate studies.
Further, there were no studies that showed harm. And the very fact that the Petition made
it to hearing is prima facie evidence that 5 CCR 1006-2; Regulation 6(D)(2)(A) and (B) are
inapplicable. Dr. Vandykes statement to the Board regarding this regulation was erroneous, as
the record both at the MMSAC and the Board hearings were robust in research data supporting
adding PTSD to the list of debilitating conditions. Exhibit A; pgs. 101-103; Exhibit B; pgs. 3032; Exhibit C; pg. 3 12-13.
Plaintiffs request the record be supplemented with all information provided to MMSAC,
because it is imperative for the Court see the full record in this matter as MMSAC based their
strong support and express recommendation of approval of the Petition on this data, including
studies providing data supporting the Petition. Further, the Board was supplied these materials,
although testimony was not permitted at the July 15, 2015 hearing.
The supplemental materials show four studies pertaining to THC or THC analogue
effects on PTSD symptoms including a presentation regarding Nabilone, a synthetic THC
analogue, which was provided for utilized in a study with 10 Canadian male military personnel
with PTSD and current distressing nightmares and a difficulty falling or staying asleep. The
outcomes of this study were assessed by monitoring the recurrent and distressing dreams,
monitoring the study participants ability to fall asleep and stay asleep, a dream rating scale, as
well as a general well-being questionnaire. Exhibit B; pgs. 22-23; citing Jetly, et al.
Psychoneuroendocrinology (2015) 51, 585-588.

13

The Nabilone study found significant

improvements of almost all categories, with no drop-outs by any of the participants. Exhibit B;
pgs. 22-23; citing Jetly, et al. Psychoneuroendocrinology (2015) 51, 585-588.
Additionally, an open label clinical trial of Nabilone for PTSD-associated nightmares was
conducted and detailed for MMSAC. In this study, 47 patients with PTSD related nightmares
participated. Nabilone was again utilized and the tracking of nightly nightmares analyzed. The
results of this study, again, reported a substantial positive result with 60 percent of all
participants nightmares ceasing and 13 percent of the participants seeing reduced severity in
their nightmares. Exhibit B; pgs. 24-25, citing Fraser GA. CNS Neuroscience & Therapeutics
(2009) 15, 84-88.
A study conducted with tetrahydrocannabinol (THC), rather than Nabilone, assessed
the tolerance, safety, and preliminary clinical effects of THC for ten patients with chronic PTSD
on stable psychotropic medications. The study utilized THC given in olive oil sublingually,
evaluating the outcomes based on heart rate, blood pressure, weight, and body mass index
variables. In addition to severity of illness and global improvement, as well as monitoring sleep
quality, nightmare questionnaires, and nightmare effect surveys. This survey, provided to
MMSAC, showed a decrease in blood pressure and significant decrease in PTSD symptoms,
including less hyperarousal, better sleep quality, decreased nightmare frequency and effects.
Exhibit B; pgs. 26-27, citing Roitman P, et al. Clin Drug Investig (2014) 34, 587-591.
Another observational study sought to determine indications and efficacy of Nabilone.
This observational study included 104 Canadian male inmates with serious mental illness, most
notably PTSD. The outcomes were assessed by self-reported sleep and nightmare evaluation.
The study found a significant increase in hours slept and reduction in nightmare frequency,

14

amongst other positive outcomes. Exhibit B; pg. 28; Cameron C, et al J Clin Psychopharmacol
(2014) 34-35, 559-564.
Finally, an observational study of medical marijuana for PTSD in which eighty applicants
in the New Mexico MMJ program sought physician approval found significant relief of several
major PTSD symptoms when using cannabis. Exhibit B; pg. 30; Greer FR, et al J Psychoactive
Drugs (2014) 46, 73-77.
Dr. Sisley explained the results of these studies in her presentation to MMSAC, which
ultimately led to MMSACs recommendation that PTSD be added to the list of debilitating
conditions. The Board cited a lack of scientific evidence as the reason for denying the Petition.
But the Board could have denied Plaintiffs Petition without a hearing if there were truly no
scientific support for Plaintiffs contentions. Thus, by providing a hearing, failing to consider
relevant medical studies, and then denying the Petition for lack of scientific support, the Board
violated its own procedural regulations. The Board failed to abide by the CDPHE regulation 5
CCR 1006-2; Regulation 6(D)(2).
a. It was arbitrary and capricious for the CDPHE to require further randomized
controlled studies regarding medical marijuana use for treating PTSD.
A reviewing court may reverse administrative agency's determination if court finds that
agency acted in arbitrary and capricious manner, made determination unsupported by evidence in
record, erroneously interpreted law, or exceeded its constitutional or statutory authority.
Ohloson v. Weil, 953 P.2d 939, 941 (Colo. App. 1997). The Board, as the agency, acted in an
arbitrary and capricious manner by requiring further randomized controlled studies be
administered despite the fact the MMSAC received full testimony pertaining to the current
available research. The Board demanded further randomized controlled studies, beyond those
Plaintiffs proffered in the April 10th, 2015 hearing, even though if further studies were available

15

the Board would not have allowed the witnesses and public comment to supply these additional
findings due to the time restraints the Board placed on all public comment.
The Plaintiffs sought to present evidence from MMSAC and/or from CDPHE Executive
Director and Chief Medical Officer Larry Wolk concerning their initial research and literature
review performed pursuant to 5 CCR 1006-2, Regulation 6(D)(1)-(3), which resulted in a strong
recommendation for approval of the Petition. During Dr. Sisleys testimony at the April 10,
2015 hearing--and within all of the information provided to the Board members for the July 15,
2015 hearing--available studies considered by other jurisdictions supplied ample evidence of the
positive effects that medical marijuana can have on PTSD patients. Exhibit A; pg. 47; see,
generally, see Exhibit B.
Further, in order to provide the required study material required by the Board, medical
marijuana needs to be made available to a PTSD study group. But without the appropriate
medical marijuana for these PTSD study participants, this requirement is impossible. The Board
made the determination to deny adding PTSD to the list of debilitating conditions in the face of
the same studies utilized and reviewed by thirteen other jurisdictions currently providing relief
for PTSD patients.
Additionally, the Board was not given the opportunity to hear the full testimony of Dr.
Sisley, the same testimony which provided a robust analysis of all currently available research
results, allowing for and requiring MMSAC to recommend PTSD be added to the list of
debilitating conditions allowing for medical marijuana treatment.
Issue 3: The Board Abused its Discretion When it Limited Dr. Sisleys Testimony at the
Hearing
The Board abused its discretion when it limited Dr. Sisleys testimony at the hearing and
in turn precluded consideration of pertinent research data previously supplied to MMSAC.

16

The Board expressed their desire to see results of blind, randomized studies before adding
PTSD to the list of conditions, but refused to allow Dr. Sisley to delve into the heart of the
current and relevant research available to date. Exhibit A; pgs. 98-103; ln.3; pg. 108; ln. 24; pg.
110; ln. 4; pg.110; ln.22; pg. 111; ln. 8; Exhibit C; pgs. 1-2. This is the same research that has
allowed thirteen other states to treat PTSD with medical marijuana. Further, Dr. Sisley is an
expert in this field as she has been working on such studies for the last several years, and
CDPHE approved a grant of $2,156,000 to fund another study Dr. Sisley is leading. Exhibit A;
pg. 46; Exhibit C; pg. 2.
Dr. Sisley testified at MMSAC hearing that current research and anecdotal evidence
shows that medical cannabis is effective in treating PTSD symptoms. Exhibit A; pgs. 46-50. But,
Dr. Sisley was not given the same ability and time to present the same information to the Board
that led to MMSAC recommending PTSD be added to the list of debilitating conditions allowing
for medical marijuana recommendations.
This irregularity and omission in the proceedings indicates, at a minimum, that the Board
abused its discretion by limiting Dr. Sisleys testimony to two minutes, thus denying proponents
of the Petition to present the most pertinent scientific testimony. See, generally, Exhibit B.
Further and more importantly, upon receiving and reviewing the record in this matter, it is
obvious and apparent that the appropriate research supplied to MMSAC was missing from the
Boards analysis.
Moreover, the Regulations include preliminary review of the proposed additional
debilitating condition by MMSAC, which shall review the petition information presented to the
department and any further medical research related to the condition requested, and make
recommendations to the executive director, or his or her designee, regarding the petition, and

17

the council shall make recommendations to the executive director, or his or her designee,
regarding the petition.

5 CCR 1006-2, Regulation 6(D)(3).

But despite MMSACs

recommendation to add PTSD to the list of debilitating conditions, the details regarding
previously supplied studies were effectively precluded from the Boards consideration.
CRS 25-1.5-106.5 establishes a CDPHE-governed research grant program to facilitate
objective scientific research regarding the efficacy of marijuana and its component parts as part
of medical treatment. See also 5 CCR 1006-2, Regulation 14. The CDPHE has agreed to provide
$2,156,000.00 in funding for a Placebo-controlled, Triple-Blind, Randomized Crossover Pilot
Study of the Safety and Efficacy of Four Potencies of Smoked Marijuana in 76 Veterans with
Chronic, Treatment- Resistant Post Traumatic Stress Disorder. But sadly, this grant money has
yet to be utilized, despite being awarded in December 2014. Exhibit A; pg. 46; Exhibit C; pg. 2.
This delay is due to layers of federal government red tape, thus, it is unclear when the
PTSD/marijuana randomized controlled trial will commence. Exhibit C; pg. 2. Further, the
published data from this study will not be available to the public for four years. Exhibit C; pg. 2.
This study will reach the level of rigor that the Board was demanding, but results will not
be published until at least 2019. Exhibit C; pg. 2. This is evidence of the way marijuana efficacy
research has been systematically impeded in the United States, including Colorado. Demanding
randomized controlled trials before medical marijuana can be recommended to treat PTSD under
Colorado law is an unreasonable standard as it cannot be attained in a reasonable, timely manner,
and does not address the immediate needs of PTSD patients.
The Board abused its discretion by limiting Dr. Sisleys testimony, thus denying
proponents of the Petition to present the most pertinent scientific testimony in favor of the
Petition, including substantial evidence and research information provided to MMSAC. See,

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generally, Exhibit B.

The evidence presented at the MMSAC hearing included research

conducted between 2009 and 2011 in New Mexico (the first state to authorize treating PTSD
with medical marijuana) that reported a 75 percent decrease in three major PTSD symptoms in
patients. This research used the VA-approved Clinically Administered PTSD Scale (CAPS)
method, which studies the presences of PTSD experiences and the patients responses to them,
and supports a conclusion that using medical marijuana is associated with PTSD symptom
reduction in some patients. This peer-reviewed study was published in a recent special issue of
the Journal of Psychoactive Drugs. See George R. Greer, Charles S. Grob, Adam L. Halberstadt.
PTSD Symptom Reports of Patients Evaluated for the New Mexico Medical Cannabis Program,
Journal of Psychoactive Drugs, 2014; 46 (1): 73 DOI: 10.1080/02791072.2013.873843. Exhibit
A; pgs. 101-103; Exhibit B; pgs. 30-32; Exhibit C; pg. 3 12-13.
A second study discussed at the July 15, 2015 hearing concluded that, [w]hile further
research into cannabinoid treatment effects on PTSD symptoms is required, the evaluated
evidence indicates that substantial numbers of military veterans with PTSD use cannabis or
derivative products to control PTSD symptoms, with some patients reporting benefits in terms of
reduced anxiety and insomnia and improved coping ability. Use and effects of cannabinoids in
military veterans with posttraumatic stress disorder Betthauser K, et al. Am J Health Syst
Pharm. 2015. Exhibit C; pg. 3 13.
The Board abused its discretion by ignoring relevant studies during the July 15, 2015.
This information, provided in great detail to MMSAC on April 10, 2015, provided many answers
to the Boards confusion and doubt.

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Issue 4: The Board Violated C.R.S. 25-1.5-106, Which Imposes a Duty on CDPHE to
Ensure that Patients Can Safely Gain Access to Medical Marijuana.
The individual Plaintiffs access to appropriate medicinal strains of marijuana has been
severely impeded by the Boards refusal to recognize PTSD as an appropriate condition for
medical marijuana recommendations. As such, the Defendant has failed in their duty to ensure
that PTSD patients have reasonable access to medical marijuana.
C.R.S. 25-1.5-106 sets forth the powers and duties of the CDPHE to administer this
constitutionally authorized medical marijuana program, including the duty, to ensure that
patients suffering from legitimate debilitating medical conditions are able to safely gain access to
medical marijuana C.R.S. 25-1.5-106(1)(a). Because of the improprieties in procedure and
materials considered, as detailed more fully above, the Defendant has failed to discharge their
statutorily-mandated duties.
Fundamentally, the Boards failure to consider appropriate evidence, such as the evidence
considered by MMSAC, constitutes error and merits reversal and/or remand. Platinum Props.
Corp. v. Bd. of Assess. App., 738 P.2d 34 (Colo. App. 1987)(Abuse of discretion by board of
assessment appeals exists where board failed to consider evidence of value of similar properties
in other counties in Colorado and other states for purposes of property tax assessment.). Clearly,
the Plaintiffs are prejudiced by the failure of the Board to consider this information, as it
supports the conclusion that PTSD can be treated at least in part by the use of medicinal
marijuana. The Boards failure to allow this debilitating condition to be added to the list of
qualifying conditions prevents the Plaintiffs from obtaining the relief they seek and need to treat
their range of PTSD-related maladies.

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CONCLUSION
Plaintiffs respectfully request that the Court reverse the Boards decision denying the
Petition and order the Board to recognize PTSD as a qualifying condition for medical marijuana
recommendations.

Respectfully submitted this 9th day of March, 2016.

/s/ C. Adam Foster
/s/ Jean E. S. Gonnell
/s/ Robert T. Hoban
Hoban & Feola, LLC
Original Signatures on File

Certificate of Service
The foregoing was served on all appearing parties of record via ICCES on March 9,
2016.

/s/ Kathryn J. Strickland

Original Signature on File

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