Matthew Kahl Et. Al. Versus CDPHE

8/19/2019 Matthew Kahl Et. Al. Versus CDPHE

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DISTRICT COURT, CITY AND COUNTY OF DENVER,STATE OF COLORADO

City and County Building1437 Bannock Street

Denver, CO 80202720-865-8301 _________________________________________________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:

Robert T. Hoban, #33151C. Adam Foster, #35969Jean E. S. Gonnell, #44623Hoban & Feola, LLC730 17th Street, Suite 420Denver, Colorado 80202Telephone: 303-674-7000

Case Number: 15CV32969

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 Health’s

(the “Board”) refusal to recognize PTSD as an appropriate condition for medical marijuana


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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 Defendant’s 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 ascancer, glaucoma, and infection with or positive status for human immunodeficiency virus.Patients undergoing treatment for such condition are defined as having a debilitating medical


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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 f or Judicial Review Pursuant to

C.R.S. § 24-4-106 , the Defendant acted in an arbitrary and capricious manner in Board’s 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.

Sisley’s 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. Sisley’s Slideshow Presentation); pg. 18.

condition. B- Debilitating medical condition also includes a chronic or debilitating disease ormedical 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 patient’s physician, such condition or conditions may reasonably bealleviated by the medial use of marijuana: cachexia; severe pain; severe nausea; seizures,including those that are characteristic of epilepsy; or persistent muscle spasms, including thosethat are characteristic of multiple sclerosis.”


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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. Sisley’s 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 marijuana—coupled with

the New Mexico study referenced above and testimony that prescribing medical marijuana was

consistent with clinician’s 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 Health’s (“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 Environment’s (“CPDHE”) Regulation 6(D) procedure that applies when patients or

physicians petition the Board to add debilitating medical conditions to the list?


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Issue 3: Did the Board abuse its discretion when it limited psychiatrist and PTSD expert

Suzanne Sisley MD’s 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 ofstatutory right, contrary to constitutional right, power, privilege, or immunity, inexcess of statutory jurisdiction, authority, purposes, or limitations, not in accordwith the procedures or procedural limitations of this article or as otherwiserequired by law, an abuse or clearly unwarranted exercise of discretion, basedupon findings of fact that are clearly erroneous on the whole record, unsupported by substantial evidence when the record is considered as a whole, or otherwisecontrary to law, then the court shall hold unlawful and set aside the agency actionand shall restrain the enforcement of the order or rule under review, compel anyagency 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 beappropriate. In making the foregoing determinations, the court shall review thewhole record or such portions thereof as may be cited by any party. In all casesunder review, the court shall determine all questions of law and interpret thestatutory and constitutional provisions involved and shall apply suchinterpretation 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


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decision is a question of law. Ace West Trucking, Inc. v. Public Utilities Com’n of State of Colo.,

788 P.2d 755, 762 (Colo. 1990).

In determining whether an agency’s 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 agency’s 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 rulesadopted pursuant to a statutory rule-making proceeding by demonstrating that the

rule-making body acted in an unconstitutional manner, exceeded its statutoryauthority, 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 orcapricious, the court must determine whether a reasonable person, considering allof the evidence in the record, would fairly and honestly be compelled to reach adifferent conclusion. If not, no abuse of discretion has occurred and the agencydecision must be upheld.

Ramseyer v. Colo. Dept. of Soc. Servs., 895 P.2d 1188 (Colo. App. 1995).

ARGUMENT

Issue 1: The Board’s 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:


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(I) Cancer, glaucoma, positive status for human immunodeficiency virus, oracquired immune deficiency syndrome, or treatment for such conditions;

(II) A chronic or debilitating disease or medical condition, or treatment for suchconditions, which produces, for a specific patient, one or more of the following,

and for which, in the professional opinion of the patient’s physician, suchcondition or conditions reasonably may be alleviated by the medical use ofmarijuana: cachexia; severe pain; severe nausea; seizures, including those that arecharacteristic of epilepsy; or persistent muscle spasms, including those that arecharacteristic of multiple sclerosis; or

(III) Any other medical condition, or treatment for such condition, approved bythe 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 CDPHE’s 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) also…include…a chronic or debilitating

disease or medical condition other than HIV infection, cancer or glaucoma; or treatment for such


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conditions, which produces for a specific patient one or more of the following, and for which, in

the professional opinion of the patient’s 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 peer-

reviewed 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, 232-

316, 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).


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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 patient’s 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 inthis matter, it became apparent that the materials presented to the MMSAC, including but notlimited to Exhibit A, attached hereto, were not presented to the Board. Yet these materialsdemonstrate the unequivocal presence of scientific literature and evidence demonstrating thatmedicinal cannabis can be effective for the treatment of PTSD. Because these materials were notincluded as part of the record, Plaintiffs hereby expressly request that the Court consider thesame and/or supplement the record accordingly, because “[a]s to alleged errors, omissions, andirregularities 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, andthe decision, findings, and action of the agency.” C.R.S. §24-4-106(6)(emphasis added). Andthis request is both timely and proper because of there are no time limitations relating toobjecting to or supplementing the record designated. Harris v. District Court , 655 P.2d 398(Colo. 1982).


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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 MMSAC’s and Dr. Wolk’s 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 Board’s 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 Board’s 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


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capricious conduct; however, any impropriety in the administrative process will not require

reversal unless a plaintiff can demonstrate prejudice).

Issue 2: The Board’s Failed to Comply with the CDPHE’s 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 adebilitating medical condition within (180) days of receipt of such petitionwithout any hearing of the board in all of the following circumstances:If there are no peer-reviewed published studies of randomized controlled studiesnor well-designed observational studies showing efficacy in humans for use ofmedical marijuana for the condition that is subject of the petition;

If there are peer-reviewed published studies of randomized controlled trials orwell-designed observational studies showing efficacy in humans for the conditionthat is the subject of the petition, and if there are studies that show harm, otherthan harm associated with smoking such as obstructive lung disease or lungcancer, and there are alternative, conventional treatments available for thecondition …

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. Vandyke’s 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


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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. Vandyke’s 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. 30-

32; 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 participant’s 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. The Nabilone study found significant


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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,


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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 MMSAC’s 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 randomizedcontrolled 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


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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. Sisley’s 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. Sisley’s Testimony at the

Hearing

The Board abused its discretion when it limited Dr. Sisley’s testimony at the hearing and

in turn precluded consideration of pertinent research data previously supplied to MMSAC.


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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. Sisley’s 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

Board’s 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


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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 MMSAC’s

recommendation to add PTSD to the list of debilitating conditions, the details regarding

previously supplied studies were effectively precluded from the Board’s 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. Sisley’s 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 patient’s 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 Board’s 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 Board’s 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 Board’s 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 Board’s 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 Board’s 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. HobanHoban & 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. StricklandOriginal Signature on File

Documents

Matthew Kahl Et. Al. Versus CDPHE