19 20) a a 2 Ey a 28 ey 0 IN THE OFFICE OF ADMINISTRATIVE HEARINGS In the Matter of: No. 2018-MMR-0098-DHS. Brandy Williams, Arizona Mothers ADMINISTRATIVE LAW JUDGE ‘Advocating Medical Marijuana for Autism DECISION and Jack Wilborn and Jana Wilborn Appellants HEARING: May 8, 2018, May 9, 2018, and June 20, 2018. The record was held open until July 12, 2018 to allow the parties to submit written closing arguments. APPEARANCES: Gregory Falls, Esq. and Matthew Hesketh, Esq. appeared on behalf of the Arizona Department of Health Services. Sonia Martinez, Esq. appeared on behalf of Appellants Brandy Williams, Arizona Mothers Advocating Medical Marijuana for Autism, Jack Wilborn, and Jana Wilborn. ADMINISTRATIVE LAW JUDGE: Velva Moses-Thompson FINDINGS OF FACT 1, Onor about July 27, 2017, Appellants filed a petition with the Arizona Department of Health Services (‘Department’) to add Autism Spectrum Disorder (‘ASD’) to the list of debilitating conditions defined in Arizona Revised Statutes section 36-2801(3) and Arizona Administrative Code R9-17-201. See Exhibit 14. 2. On October 27, 2017, the Department issued a notice denying the petition. 3. The Department denied the petition because it did not fully meet the Fequirements of A.A.C. R9-17-106 (A)(6) and (7), and A.A.C. R9-17-106(B)(2) ‘The Department concluded that the petition failed to establish that any individual diagnosed with ASD is impaired in his or her ability to accomplish activities of daily living. The Department determined that the petition failed to provide evidence that the use of marijuana will provide therapeutic or palliative benefit to an individual suffering | __ Office of Administrative Hearings] 11740 West Adams Steet, Lower Level Phoenix, Arizana 85007 (62) 542-0826from ASD or treatment of ASD. The Department also determined that the petition lacked a peer reviewed article that was published in a scientific journal, reporting the results of research on the effects of marijuana on ASD or the treatment of ASD. The Department's October 27, 2017 denial provides, in relevant part, as follo 10 " 2 13 18 19 20 a 2 2 24 2 2% a 8 a The petition does not include any evidence of a study involving humans and marijuana that has been published in a peer reviewed journal The petition identifies in twenty-four footnotes specific online resources, copies of which appear to have been attached. The first thirteen footnotes provide substantial details regarding a description of ASD, its symptoms, and the availability and efficacy of conventional medical treatments. Certain footnotes also support the conclusion that not every ASD patient is impaired in the ability to accomplish activities Of daily living. See, e.g., footnote 1 at 11. Footnote fourteen is a trial record of a clinical trial "currently recruiting participants" to assess the safety, tolerability, and efficacy of cannabinoids mix [CBD and THC in a 20:1 ratio] for behavioral problems in children and youth with ASD. According to footnote fifteen at 1, this study is the first of its kind in the world. Clinical trials can produce solid reliable evidence when they are completed. The lead physician himself "cautions against premature conclusions about the study." Footnote sixteen appears to be a summary of cannabis treatment for Inflammatory Bowel Disease, not broad spectrum ASD. Footnote eighteen is a summary on Movement disorders, such as Huntington's disease and Parkinson's disease. Footnotes seventeen and nineteen involve a discussion of molecular or neurologic theory on the endocannabinoid system and cannabinoid receptors. Such theoretical writings may be a necessary precursor to tests on humans, but they are not sufficient evidence that the use of marijuana will provide therapeutic or palliative benefit for the medical condition or a treatment of the medical condition that is the subject of the petition, ASD. Footnote twenty is a study on mice, not humans Footnotes twenty-one through twenty- four are statements of opinion and individual testimonials from online sites and journals which are not peer reviewed 218 1° 20 2 22 2 2 25 2 a 28 ey 30 4. On or about November 20, 2017, Appellants filed an appeal 5. The matter was referred to the Office of Administrative Hearings for an evidentiary hearing, 6 On November 21, 2017, the Department issued a Notice of Hearing setting the matter for hearing at 1:00 p.m. on January 17, 2018, at the Office of Administrative Hearings in Phoenix, Arizona. * 7. Appellants presented the testimony of Dr. Christian Bogner, Dr. Judy Mikovitz, Dr. Heather Morosso, Franco Shadowlynn McLaughlin, Shaun Simpson, Erica Smith, Sommer Walter, Jacob Welton, Alexandra Selver Taylor, and Petra Paukova 8. The Department presented the testimony of Dr. Vira Villarroel and Krystal Colburn, 9. _ Dr. Christian Bogner is the medical director of Oxford Recovery Center in Michigan. Dr. Bogner's primary focus is autism and epilepsy. Dr. Bogner has approximately 50 patients in his practice whom he treats with cannabis. Dr. Bogner has Conducted research on autism and cannabis. Dr. Bogner has a 13 year old child who has been diagnosed with ASD 10. In the article, "The Endocannabinoid System as it Relates to Autism’, Dr. Bogner implies that ASD alone is not debilitating, Dr. Bogner’s article provides, in relevant part, as follows:? Which has more potential for damage, THC or the slew of other environmental toxicity, oxidative stress, and neuronal insult factors that autistic brains are suggested to be more vulnerable to (Kern 2006)? That answer seems dependent on the severity of the condition, and it's important to note that we're only referring to truly debilitating forms of ASD. Equally relevant is that the cognitive deficits are inhibited by CBI antagonists like CBD (Sarne 2011). Given the available data if a child has a form of autism that is truly debilitating, and is unresponsive to available treatments, should their family and physician be legally 1 The hearing was continued and convened on May 8, 2018. ? See Exhibit 15, Tab. 17, page 7. 318 9 20 2 2 2 24 25 Ey 8 cy permitted to make the decision as to whether botanical extracts from cannabis may be a viable option for treatment, and the lesser of two evils? We believe that families and physicians should have the legal right to explore these options on an individual basis without fear of prosecution. (Emphasis Added). However, Dr. Bogner opined at hearing that ASD is “absolutely debilitating” No matter where a person falls on the spectrum. 11. Dr. Bogner opined that cannabis can limit inflammation in the brain Dr. Bogner opined that treatment of cannabis does not “fix” the underlying problem, but Provides immediate relief. However, Dr. Bogner testified that some children have lost the ASD diagnosis after being treated with cannabis. 12. Dr. Bogner disagrees that a person diagnosed with ASD will have the condition forever. Dr. Bogner has seen children diagnosed with ASD stop banging their head and gain back their appetite after beginning cannabis treatment. 13. _ Dr. Bogner testified that an overdose of cannabis has not been shown to be harmful. Dr. Bogner testified to the effect that the brain will operate normally if inflammation is removed. Dr. Bogner also testified to the effect that that not every child fits the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ("DSM-5") oriteria, 14. _ Dr. Bogner opined that using cannabis would be a concem if it remained for a person's lifetime. Dr. Bogner testified that with regard to the Food and Drug Administration approval, research should include a certain amount of subjects to ensure benefits of the medication outweigh the risks. Dr. Bogner stated that randomized double blind studies should be completed on persons diagnosed with autism. However, Dr. Bogner opined that randomized double blind studies are not needed to validate whether a compound is helpful for a specific disease or condition, 15. Dr. Judy Mikovitz holds a Bachelor of Arts degree in Biology with a specialization in Biochemistry from the University of Virginia in Charlottesville, Virginia. Dr. Mikovitz received a Ph.D. in Biochemistry and Molecular Biology from the George Washington University in Washington D.C. Dr. Mikovitz works for a consulting company in Carlsbad, CA. The company teaches physicians about dosing and explores immune 410 1" 2 20 a B 24 25 8 2 28 29 related adverse events. Dr. Mikovitz testifies in vaccine court. Dr. Mikovitz testified that she completed a study related to the value of the endocannabinoid system which was approved as a continuing education course by doctors. 16. Dr. Mikovitz opined that autism should be added to the list of debilitating conditions because medical marijuana is curative and causes no harm 17. _ Dr. Mikovitz opined that any individual with autism has an impairment. 18. Dr. Mikovitz testified that there are clinical studies which have shown Persons with ASD that who were cured by medical marijuana, but not medical marijuana alone. 19. Dr. Mikovitz opined that the Department unreasonably rejected the Petition. Dr. Mikovitz opined that marijuana can prevent the effects of autism. Dr. Mikovitz testified that peer reviewed and published studies have shown that marijuana has a curative effect, but there have been no double blind placebo controlled Studies conducted regarding the effect of medical marijuana on humans with ASD. 20. Dr. Heather Moroso is a Naturopathic doctor. Dr. Morosso received a Doctor of Naturopathic Medicine degree from Southwest College of Naturopathic Medicine in Tempe, Arizona. Dr. Morosso holds a Bachelor's degree in Oncology and Evolutionary Biology with a minor math, chemistry and physics from the University of Arizona 21. Dr. Morosso began studying medical marijuana in 2011. Dr. Morosso assesses patients to determine whether they have a qualifying condition for medical marijuana. Dr. Morosso has processed 7500 medical marijuana certifications, not including renewals. Dr. Morosso works with about 80% of the patients that she has helped on a consistent basis. Dr. Morosso has seen medical marijuana reduce the side effects of pain and repetitive aggressive behaviors in her patients. Dr. Moroso testified that medical marijuana helps aggression, seizures and chrome’s disease. 22. Dr. Morosso opined that autism is a debilitating condition and that medical marijuana has a palliative effect on ASD. Dr. Morosso testified to the effect a person can be impaired even though the person works.4 6 16 7 20 a 2 2 2 6 a 8 23. _Kyrstal Colbum is the Bureau Chief of Vital Records at the Department. Ms. Kolburn reviewed and signed the denial letter in this matter. Ms. Colburn holds a Bachelor's degree in Community Health Education. 24. Dr. Vira Villarroe! obtained a Doctor of Medicine degree from Northwestern University. Dr. Villarroel obtained a Bachelor's degree from Princeton University. Dr. Villarroel completed her residency at Banner Good Samarian in Phoenix, Arizona. Dr. Villarroel is board certified in family medicine. 25. Dr. Villarroel is the medical director of the Division of Public Health Preparedness. She serves as a medical consultant for the Department's bureaus. Dr. Villarroel has been a part of the team that reviews petitions for approximately three years. Dr. Villartoel had been seeing patients every Friday since 2014. Dr. Villarroel was a part of the team that reviewed Appellants’ petition. Thomas Salow, the Chief of the Bureau of Vital Records, was also a part of the team. 28. _ Dr. Villarroel has taken several classes related to medical marijuana 27. _ Dr. Villarroe! studied the human cannabinoid system in law school. Dr. Villarroe! reviews petitions to determine whether debilitating conditions should be added to the list and takes calls from clinicians regarding medical marijuana. Dr. Villarroel has treated and recommended medication for patients with autism 28. _ Dr. Villarroel testified that one of the reasons that the petition was denied was because it did not include a study that involved the treatment of a human with marijuana that was completed and published. Dr. Villarroel also testified that the petition was denied because it did not contain any articles which were published in a peer-reviewed scientific journal. 29. With regard to the petition, Dr. Villarroel opined that the Department accepted the definition of autism presented in the petition.? Dr. Villarroel opined that the information submitted in the petition was insufficient to show that medical marijuana has a therapeutic and palliative effect because the petition did not an article that was. Published in a peer reviewed journal. The petition consisted of several print outs from various websites, none of which had been published in a peer reviewed journal * See Volume IV, Tab 14, Exhibit 1, page 4. “A mildly affected person might seem merely quirky and lead @ relatively typical life. A severely affected person might be unable to speak or care for himself.” 69 20 a 22 a Pa 25 28 a 28 2 30 30. The petition also contained abstracts of various studies. Dr. Villarroel opined that abstracts can misrepresent the material in a published article. An abstract is a summary of a conclusion of a study, but not the actual study. Dr. Virrarroe! also opined that the results of a study where persons diagnosed with another disease were treated with medical marijuana cannot be extrapolated and applied to make a conclusion about how medical marijuana affects persons diagnosed with ASD. 31. _ Dr. Villarroel testified to the effect that there is a hierarchy of evidence. Dr. Villarroel studied the evidence pyramid in law school. The Department's team looks || for scientific evidence from the entity submitting the petition. Dr. Villarroel reviewed AAC. R9-17-106 2 (a) and (b) when assessing whether the petition should be approved. 32. Dr. Villarroel opined that the rule at A.A.C, R9-17-106 is based upon Science and logic. Dr. Villarroel testified that the testimony of Ms. Williams and Mr. ‘Wilborn would not be on the evidence pyramid. Dr. Villarroe! opined that the testimony of Dr, Moroso, Dr. Mikotovitz, and Dr. Bogner is considered expert opinion and would fall at the bottom of the evidence pyramid. 33. Dr. Villarroel opined that animal research is important but it is considered a pre-clinical study. Dr. Villarroel opined that the conclusions drawn from animal studies cannot be applied to humans. 34. Jack Wilborn is a part of the Law Enforcement Action Partnership. The Law Enforcement Action Partnership supports cannabis education. Mr. Wilborn met Brandy Williams and Logan through the Law Enforcement Action Partnership 35. Brandy Williams is the director of the Arizona Mothers Advocating Medical Marijuana for Autism (‘MAMMAS'). MAMMAS has over 368 members in Arizona. Jack and Jana Wilborn helped Ms. Williams create the petition. Ms. Williams gathered the Petitions that were filed in other states within the United States. Ms. Williams filed the Petition to have autism added to the list of debilitating conditions defined in Arizona Revised Statutes section 36-2801(3) and Arizona Administrative Code R9-17-201 36. _In February of 2013, Ms. Williams's son Logan was diagnosed with autism. Logan has severe autism and inflammation. Logan tured eight years old in May of 720 a 2 23 2 25 eA ar 2 30 2018. In April of 2016, Logan was diagnosed with seizures. Logan qualifies for medical marijuana due to seizures. 37. Ms. Williams testified that she has suffered from what is akin to survivor's guilt because the other parents in her organization cannot give their children medical ‘marijuana because their children do not suffer from seizures. 38. Although Logan was prescribed Risperdal, Ms. Williams never gave Risperdal to her son because she stated that her family has had a history of experiencing adverse side effects to Risperdal 39. Before Logan began taking medical marijuana, he placed his head through double paned glass windows, he had abnormal eye movements, and Logan has intense behavioral interventions and had to have therapies several times a week. Logan was forced to leave therapy centers and had meltdowns and would not participate in therapy. Ms. Williams testified that after her son first began taking medical marijuana, within 20 minutes, her son's hand flapping stopped. Logan would sit down slowly and stopped running in circles. For the first time, Logan watched a movie with Ms. Williams and provided emotional responses at the proper times. Logan said 180 words in the first two months after taking medical marijuana. Logan is no longer and threat and attends @ public school. Ms. Williams testified that doctors have confirmed Logan’s progress. 40. Ms. Williams stated originally, only cannabis flowers were available. Ms. Williams started Logan on the CBD compound which was effective in treating Logan's inflammation. Ms. Williams testified to the effect that the CBD compound did not have any effect on Logan's behaviors. Ms. Williams testified that her son needed the whole marijuana plant. 41. Ms. Williams testified to the effect that before Logan began taking medical marijuana, everyone in her life was impacted. People would stare at her and give her dirty looks. Ms. Williams testified that she was in a constant state of fear, anxiety and rage. 42. Ms. Williams testified that she never gave Risperdal to her son because her cousin had a bad reaction to the medication10 2 2 “4 6 w 18} 20 2 2 2 2 25 Ey a 2 30 43. Shawn Simpson is Brandy Williams's husband. Mr. Simpson testified that Logan recently lost access to successful strains of medical marijuana and has regressed. Mr. Simpson testified that he has to worry about his son overdosing if he gives him antidepressants. Mr. Simpson stated that Logan has become more anxious and will not sit in one spot. Mr. Simpson testified that it is difficult to get his son to sleep. 44. Mr. Simpson testified that before him and Ms. Williams gave Logan cannabis, Logan would rip out his beard. The worst that Mr. Simpson has heard about cannabis is that a person might be too anxious and have to sit in a dark room. Mr. Simpson testified that he did not give his son Risperdal because of its side effects and his son was already self injurious and violent. 45. Franco Shadowlynn McLaughlin testified that she has a nine year old son named Skylar who has been diagnosed with Autism and Marfans syndrome. Ms McLaughlin lives in El Mirage, AZ. Skylar takes speech therapy. 48. Ms. McLaughlin testified that her son is eligible to receive medical marijuana because marfans syndrome affects her son's heart. Ms. McLaughlin testified that she cannot give her son other behavioral medicines because of the effect that they have on her son’s heart. Furthermore, Ms. McLaughlin testified that her son has bad side effects to Risperdal including outbursts and uncontrolled rage. 47. Skylar began taking medical marijuana around September 2017. Ms. McLaughlin testified that after taking the medical marijuana, his son makes eye contact and bathes himself regularly. Ms. McLaughlin has not seen her son experience any negative side effects except that he wants to sleep more. Before taking medical marijuana, her son would constantly fight. Ms. McLaughlin testified that Skylar has less agitation and is much happier. Before taking medical marijuana, Ms. McLaughlin would have to divert people from her son and now he wants to get closer to people. Originally, ‘Skylar's school told Ms. McLaughlin that Skylar could not be on medication and attend school. However, after she Ms. McLaughlin stopped the medication, the school informed Ms. McLaughlin that she needed her to start the medication again because he was having an increased number of times in which he was required to be physically10 " 3 14 6 18 9 2» a 2 23 24 ey ar 28] a 0 restrained. Ms. McLaughlin testified to the effect that her son has an intelligence quotient of 138, but that he cannot brush his teeth or wipe his backside. 48. Ms. McLaughlin gives Skylar medical marijuana in the form of oil. Skylar's caregiver gives the oil to Ms. McLaughlin and she puts the oil into a gel cap. Ms. McLaughlin believes that Skylar’s condition improved due to the medial marijuana alone because she did not change Skylar’s diet, medicine or therapies. 49. _ Erica Smith testified that she is a registered nurse and lives with her husband and two boys. Both of Ms. Smith's sons have been diagnosed with ASD but only one has seizures. Her son who has seizures is eligible to receive medical marijuana. Ms. Smith tried giving her son prescription drugs but he experienced several negative side effects. Ms. Smith testified that she started giving her son medical marijuana on April 11, 2018 and as of the day of the hearing, it was day 70. Ms. Smith testified to the effect that she has a whole new child. After the first day of giving her son cannabis, the number of hard hits to the fold of the wall decreased by 70%. Ms. Smith's son went to bed calmly. Ms. Smith testified that people are constantly reporting how he is improving. Now, her child recognizes himself in photos and every day he says a new word. Ms. Smith is not concerned with any potential long term side effects 50. Sommer Walter lives in Mesa, AZ and has two children with ASD. One of her children also has epilepsy. Ms. Walter obtains a full extract of cannabis which comes in a syringe. Ms. Walter puts it ina capsule. Before taking cannabis, Ms. Walter's child could not be left alone. Ms, Walter and her husband could not walk ‘out of a room where her son was without making sure someone was watching her son. 51. Jacob Welton testified that his deceased son Zander was diagnosed with autism and seizures. Mr. Welton witnessed a significant improvement in Zander's behaviors after Zander began taking medical marijuana. On the third day after Zander began taking medical marijuana, Zander looked at Mr, Welton for the first time. Zander began understanding appropriate responses. Ms. Welton was not wortied about the long term effects, if any, of marijuana 52. Alexandra Selver Taylor lives in Gilbert with her son and husband. Ms. Taylor's husband is a retired Phoenix police officer. Mrs. Taylor's son has been diagnosed with autism and epilepsy. Mrs. Taylor and her husband lived in fear in their 1010 " 2 a 14 8 19 20 a 2 23 6 cy 26 2 28 2 0 ‘own home before their son began taking medical marijuana. Mrs. Taylor's son’s aggression issues significantly decreased after their son began taking medical marijuana. Mrs. Taylor testified that her son has hit every goal on his IEP which he has never done in his life. Mrs. Taylor also testified that her son began being affectionate after taking medical marijuana. Mrs. Taylor's son does not have any negative side effects from the medical marijuana. Her son easts better and is less picky. Ms. Taylor uses an oil in a syringe and places it under her son's tongue to administer the marijuana medication. 53. Petra Paukova is a music therapist and Logan, the son of Brandy Williams, isher client. Ms. Paukova stated that before Logan began taking medical marijuana, Logan was self-injurious and could not do anything. Ms. Paukova saw Logan once per week for an hour. She stated that she could not communicate with Logan and was exhausted after an hour. However, after Logan began taking medical marijuana, Ms. Paukova noticed a significant improvement in his behavior, 54. Appellants contended that the denial was made by persons with no education or background experience with medical marijuana and autism. Appellants contended that it presented expert testimony regarding the endocannabinoid system and the development of botanical drugs to assist with ASD. 55. Appellants contended that the definition of autism is found in the DSM-5 which characterizes it as being debilitating.* Appellants contended that the personal testimony presented at hearing establishes that autism is debilitating. Appellants argued that Dr. Moroso testified that a person with ASD has symptoms that vary from hour to hour. Appeliants contended that its experts testified regarding the events that occur at the molecular and cellular level in a person with ASD, and that ASD is the result of deficiencies in the endocannabinoid system. Appellants contended that they Presented evidence that autism is curative and reversible and that they only need to show evidence of some therapeutic and palliative effect. Although Appellants contended that he DSM-5 was included in the petition, Appellants made a reference to a print out of the frequently asked questions section of the ‘autismspeak org’ website. The printout nor the remainder of the petition contains the actual language of the DSM-S. "4" 2 19 4 18 19 20 a 2 23 2 25 6 a Ey 56. The Department contended that ADHS is authorized to develop a rule for adding other debilitating conditions to the list. The Department argued that AMMA does not specify how this should be done, but it authorized the department to create rules for adding other conditions to the list. 57. The Department contended that a team of qualified individuals issued the denial. The Department contended that Ms. Kolburn and Thomas Salow are familiar with the medical marijuana program. The Department contended that Dr. Villarroel is a board certified physician and has treated patients with autism 58. The Department contended that the petition on its face shows that having ASD alone does not mean that the person has a debilitating condition. See Department's post hearing brief, pages 5-7. 59. The Department contended in its post-hearing brief, ‘Without specifying an exact DMC approval process, the proponents of AMMA did, however, make it crystal clear that Arizona's process would be far more rigorous than that of California, for example, where any doctor may recommend medical marijuana for any patient with any medical condition Unlike California, where it's possible to get a doctor's recommendation to use marijuana for almost any condition only patients with a limited number of serious and debilitating conditions . . . will be able to acquire medical marijuana in Arizona. Andrew Myers, Campaign Manager, Arizona Medical Marijuana Policy Project, Arguments “For” Proposition 203, Arizona Secretary of State 2010 Publicity Pamphlet 84 (2010), http://apps.azsos. govielection/201 O/info/pubpamphiet/english/e-book.pdt (last visited July 3, 2018) (emphasis added). See also State v. Kemmish, 244 Ariz. 314, 319, 118, 418 P.3d 1087, 1092 (App. 2018) (recognizing the differences between AMMA and California's Compassionate Use Act). “[BJallot materials and publicity pamphlets circulated in support of the initiative” may be considered in attempting to determine the electorate’s intent. Id. at 317, {] 10, 418 P.3d at 1090 (quoting Ruiz v. Hull, 191 Ariz. 441, 450, $1 38, 957 P.2d 984, 993 (1998)); see also State Gear, 239 Ariz. 343, 345, {] 11, 372 P.3d 287, 289 (citing AMMA’s publicity pamphlet).”> 5 See Department's post-hearing brief at 2. 2v 18 1° 20 2 22 23 2 2s 2% Fa 2 2 30 60. The Department argued that the petition did not have one article that was published in a peer-reviewed scientific journal that reported the results of research on the effects of marijuana on an individual diagnosed with ASD. 61. The Department contended that the Appellants provided an abstract and newsletter regarding a study from Israel regarding the effects of cannabis on persons with ASD which had an estimated completion date of July 2019. Additionally, the study was currently recruiting participants, Although the study appeared to be double blind placebo, it was not completed. The abstract itself cautioned about making premature conclusions. 62. The Department also argued that under State v. Jones, No. 1 CA-CR 16- 0703, 2018 WL 3121440 (Ariz. Ct. App. June 26, 2018), the Department may not approve the use of any extracts of marijuana. See Department's post hearing brief, pages 15-17 and 28-32. The Department contended that Appellants did not provide any evidence from any of the parents that they were using marijuana to treat their children. Rather, the parents extracted parts of the plant and using it to process oils. The Department contended that approving the petition would only allow for the use of cannabis to treat ASD which is illegal under State v. Jones. CONCLUSIONS OF LAW 1. Appellant bears the burden of proof and the standard of proof on all issues in this matter is that of a preponderance of the evidence. A.A.C. R2-19-119. 2. Apreponderance of the evidence is: The greater weight of the evidence, not necessarily established by the greater number of witnesses testifying to a fact but by evidence that has the most convincing force; superior evidentiary weight that, though not sufficient to free the mind wholly from all reasonable doubt, is still sufficient to incline a fair and impartial mind to one side of the issue rather than the other. BLACK’s LAW DICTIONARY 1301 (9" ed. 2009). 3. Ariz. REV. STAT, section 36-2803 provides: Rulemaking; notice 310 " 2 13 “ 6 16 7 1 19 20 a 2 a 4 2 26 a 2% 2 30 (Caution: 1998 Prop. 105 applies) ‘A. The department shall adopt rules: 1. Governing the manner in which the department considers petitions from the public to add debilitating medical conditions or treatments to the list of debilitating medical conditions set forth in section 36-2801, paragraph 3, including public notice of, and an opportunity to comment in a public hearing on, petitions. Ariz. REV. STAT. section 36-2801.01 provides Addition of debilitating medical conditions (Caution: 1998 Prop. 105 applies) The public may petition the department to add debilitating medical conditions or treatments to the list of debilitating medical conditions set forth in section 36-2801, paragraph 3. The department shall consider petitions in the manner required by department rule, including public notice and hearing. The department shall approve or deny a petition within one-hundred-eighty days of its submission. The approval or denial of a petition is a final decision of the department subject to judicial review pursuant to title 12, chapter 7, article 6. Jurisdiction and venue are vested in the superior court. Ariz. Rev. Stat. section 36-2801 provides: 3. "Debilitating medical condition" means one or more of the following (a) Cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, hepatitis C, amyotrophic lateral sclerosis, crohn's disease, agitation of alzheimer's disease or the treatment of these conditions, (b) A chronic or debilitating disease or medical condition or its treatment that produces one or more of the following: cachexia or wasting syndrome; severe and chronic pain; severe nausea; seizures, including those characteristic of epilepsy; or severe and persistent muscle spasms, including those characteristic of multiple sclerosis. 48 “ 16 16 v 18 1° 2 21 2 2 2 25 a 28 2 30 (c) Any other medical condition or its treatment added by the department pursuant to section 36-2801.01 6. Pursuant to A.A.C. R9-17-106 (A), a petitioner to add a new condition must provide the Department with: 4. A description of the symptoms and other physiological effects ‘experienced by an individual suffering from the medical condition or a treatment of the medical condition that may impair the ability of the individual to accomplish activities of daily living; 6. A summary of the evidence that the use of marijuana will provide therapeutic or palliative benefit for the medical condition or a treatment of the medical condition; and 7. Articles, published in peer-reviewed scientific journals, reporting the results of research on the effects of marijuana on the medical condition or a treatment of the medical condition supporting why the medical condition should be added 7. Pursuant to A.A.C. R9-17-106 (B)(2), the Department must review the request to determine if the petitioner provided evidence that: a. The specified medical condition or treatment of the medical condition impairs the ability of the individual to accomplish activities of daily living, and b. Marijuana usage provides a therapeutic or palliative benefit to an individual suffering from the medical condition or treatment of the medical condition; 8 A\[rule] is to be given such an effect that no clause, sentence or word is rendered superfiuous, void, contradictory or insignificant.” Guzman v. Guzman, 175 Ariz, 183, 187, 854 P.2d 1169, 1173 (App. 1993); Gutierrez v. Industrial Commission of Arizona, 226 Ariz. 395, 249 P.3d 1095 (2011)(statutes and rules are construed using the same principles). 8. The Department is required to hold a public hearing on petitions for which the petitioner has provided evidence that: (1) The specified medical condition or treatment of the medical condition impairs the ability of the individual to accomplish activities of daily living and (2) Marijuana usage provides a therapeutic or palliative 155 16 ” 18 20 a 2 2 24 ey ar 2 30 benefit to an individual suffering from the medical condition or treatment of the medical Condition. For petitions that do not meet those requirements, the Department is Tequired to provide the petitioner the specific reason for the Department's determination and to provide the petitioner with information on obtaining judicial review of the Department's decision. A.A.C. R9-17-108(B). 10. Ballot materials and publicity pamphlets may be used to ascertain voters’ intent when determining the purpose of an initiative. See Ruiz v. Hall, 191 Ariz. 444, 450 (1998), 11. Appellants failed to establish by a preponderance of the evidence that any individual diagnosed with ASD is impaired in his or her ability to accomplish the activities of daily living. The purpose of the law is to allow medical marijuana to be used for serious medical conditions. 12. The preponderance of the evidence shows that Appellants did not provide one article that was published in a peer-reviewed scientific journal reporting the result of research on the effects of marijuana on an individual with ASD or a treatment of ASD. 13. The Tribunal finds that Appellants failed to establish that its petition met the requirements of A.A.C. R9-17-106(A)(7) and (B)(2) ORDER IT IS ORDERED that Appellants’ appeal is denied. In the event of certification of the Administrative Law Judge Decision by the Director of the Office of Administrative Hearings, the effective date of the Order will be five days after the date of that certification Done this day, June 22, 2018. /s/ Velva Moses-Thompson Administrative Law Judge Transmitted electronically to: Dr. Cara Christ, Director Arizona Department of Health Services 16