FILED IN MY OFFICE DISTRICT COURT CLERK 8/16/2016 11:24:10 AM STEPHEN T. PACHECO Maureen Naranjo STATE OF NEW MEXICO FIRST JUDICIAL DISTRICT COURT SANTA FE COUNTY Nicole Sena, individually and as Next friend to A.N., a minor, and New Mexico Top Organics – Ultra Health, Inc., A New Mexico non-profit corporation, Plaintiffs, D-101-CV-2016-01971 No. D-101-CV-2016-________________ Case assigned to Thomson, David K. v. New Mexico Department of Health, and Lynn Gallagher, in her official capacity as Secretary-Designate, Defendants. COMPLAINT FOR DECLARATORY JUDGMENT AND JURY DEMAND COMES NOW Nicole Sena, individually and as next friend of A.N., a minor, and New Mexico Top Organics – Ultra Health, Inc., by and through their counsel Egolf + Ferlic + Harwood, LLC, to complain against the Defendants for declaratory judgment pursuant to the New Mexico Declaratory Judgment Act, NMSA 1978 § 44-6-1 et seq. The New Mexico Department of Health (“the Department”) and Acting Secretary Lynn Gallagher (“Gallagher”) operate the New Mexico Medical Cannabis Program (“the Program”) and promulgate rules for the Program’s operation pursuant to the Lynn and Erin Compassionate Use Act, NMSA 1978 § 26-2B-1 et seq. (“the Act”). Among the duties imposed on the Defendants by the Act is a duty to ensure a reasonably sufficient supply of medical cannabis for the demand of qualified patients to treat their debilitating conditions. Despite the Defendants’ effort to change the rules governing the Program in 2015 to address profound shortages of cannabis, the Program is still managed and governed by an arbitrary and capricious production limitation that ensures there will never be an adequate supply of cannabis in New Mexico. Shortages of medical cannabis are serious and Page 1 of 17 significant, yet the rules limiting the number of plants that a Licensed Non-Profit Producer (“LNPP”) may grow constitute artificial constraints on both supply and demand in the medical cannabis market. Under the current rules, the shortages and limits on medical cannabis products will only get worse, and the Defendants will continue to fail to meet their statutory obligations. In addition to the market-wide disruptions caused by the Defendant’s production limitation, the arbitrary and capricious limitations on LNPPs create severe limitations and acute unavailability of certain cannabis-derived products required by some of the most medically-fragile and needy patients in New Mexico. The productions limits have created a dire situation for certain patients, who simply cannot find the products they need and/or cannot obtain the adequate supply of products they are lawfully entitled to access and maintain under the Act. The Plaintiffs prays for a declaratory judgment from this Court that the rules, regulations and requirements relating to limits on the number of cannabis plants LNPPs may grow are 1) arbitrary, 2) capricious, and 3) void because they limit LNPPs such that the goals, purpose, duties and obligations of the Program and Act cannot be fulfilled. As grounds for this complaint, the Plaintiffs state the following: Jurisdiction and Venue 1. At all times relevant to this complaint, Nicole Sena has been a resident of Bernalillo County, New Mexico. She is the mother of A.N. 2. A.N. is a minor child, aged less than one year. 3. At all times relevant to this complaint, New Mexico Top Organics – Ultra Health, Inc. (“NMTO”) has been a New Mexico non-profit corporation in good standing with its principal place of business in Sandoval County, New Mexico. Page 2 of 17 4. At all times relevant to this complaint, the Defendants have been instrumentalities of the government of the State of New Mexico with their principal place of business in Santa Fe County, New Mexico. 5. The New Mexico Medical Cannabis Program (“the Program”) was created by the Lynn and Erin Compassionate Use Act, Section 26-2B-1 to -7. 6. The DOH administers the Program. Section 26-2B-3(C). 7. Secretary-Designate Lynn Gallagher is the duly authorized Acting Secretary of the DOH. 8. Secretary-Designate Gallagher is a proper party to this action pursuant to Section 446-13. 9. At all times relevant hereto, the Defendants have made their principal place of activity in Santa Fe County, New Mexico. See NMSA 1978 38-3-1 (G) (1988). 10. Venue in this Court is proper. 11. This Court has jurisdiction over this matter as a court of general jurisdiction in Santa Fe County, New Mexico. Facts 12. The purpose of the Lynn and Erin Compassionate Use Act is to “allow the beneficial use of medical cannabis in a regulated system for alleviating symptoms caused by debilitating medical conditions and their medical treatments.” Section 26-2B-2. 13. The Act establishes a regulatory framework whereby the DOH licenses consumers, caregivers, and producers of medical cannabis, while exempting them from criminal and civil penalties for use of the medicine. Section 26-2B-4. Page 3 of 17 14. The Act states that every enrolled patient may possess an “adequate supply” of medical cannabis, which is an amount sufficient to give an enrolled patient access to a continuous uninterrupted three-month supply. NMSA 1978 § 26-2B-3(A) (2007). 15. Commensurate with this definition, the Act and its rules require the Defendants to ensure that there is an adequate supply of medical cannabis grown and distributed in New Mexico to meet the needs and demand of enrolled patients. 16. To obtain “registry identification cards” allowing them to use medical cannabis, consumers must establish themselves as “qualified patients” per the terms of the Act. See Sections 26-2B-3(G), 26-2B-7. 17. A.N., and her mother are duly enrolled in the Program as a patient and a caregiver, respectively. 18. A.N. suffers from a rare form of epilepsy, a qualifying condition under the Act and its Rules. 19. Ms. Sena has found only one treatment modality that provides relief to her daughter, an oil derived from a strain of cannabis called “Haleigh’s Hope.” 20. Haleigh’s Hope is a product with high levels of CBD, a cannabis compound without psychotropic effect, and little or no THC, the cannabis compound that is psychotropic. 21. Since beginning treatment with Haleigh’s Hope, A.N.’s intractable seizures have stopped, her cognitive development has progressed, and A.N.’s overall condition is improving every day. Page 4 of 17 22. Ms. Sena believes that without access to Haleigh’s Hope, A.N.’s intractable seizures would resume, her developmental progress would cease, and she would suffer tremendously. 23. Ms. Sena has faced tremendous difficulty finding an adequate supply of Haleigh’s Hope for A.N. 24. Ms. Sena and A.N. temporarily relocated to a neighboring state so that A.N. could have access to a regular adequate supply of Haleigh’s Hope. 25. Ms. Sena has found that there is not an adequate reliable supply of Haleigh’s Hope in New Mexico. When the product is needed by A.N., Ms. Sena is often forced to leave New Mexico to find the medicine. 26. Ms. Sena believes that LNPPs in New Mexico would be able to provide an adequate and regular supply of Haleigh’s Hope if there were not restrictive regulations placed on their production. 27. Producing Haleigh’s Hope requires a volume of cannabis plant material that is far greater than almost any other cannabis product. It requires at least four times the amount of raw plant material as compared to other specialized products. 28. In the distribution system established by the Act, any person or entity seeking to produce or distribute medical cannabis (excluding qualified patients growing solely for personal use) must obtain a license from the DOH. See Section 26-2B-3(D). 29. To obtain a license, a producer must submit an extensively detailed application, which includes the following: a. Organizational information and materials, including proof that the producer is a non-profit organization, copies of the producer’s articles of incorporation Page 5 of 17 and bylaws, verification that the producer’s board includes at least one medical professional and at least three qualified patients; a list of all persons having authority or ownership interest in the facility; a business plan; and the identities of all creditors holding a security interest in the premises of the producer; b. Production and distribution information and materials, including a written set of distribution criteria describing the method by which distribution will occur; a complete description of the means the producer intends to safely dispense the cannabis; a description and sample of the packaging the producer intends to use, including a label that shall contain the name of the strain, batch, and quantity, and a statement that the product is for medical use and not for resale; and a description of the testing procedures the producer will use to determine the quality of the product; c. Facility information, including a description of the facility in which the cannabis will be produced; its complete security features and devices; and proof that it is not within 300 feet of a church, school, or daycare center; d. Educational methods and materials, including a description of the producer’s plan to educate qualified patients and their primary caregivers as to the limitations of the Act and their right to use cannabis; a description of the means the producer will use to make qualified patients and their primary caregivers aware of the quality of the product; an explanation of the means the producer will use to educate qualified patients and their caregivers about the potential side effects; and a description of the ingestion options and Page 6 of 17 information on safe smoking techniques that will be provided to qualified patients and their caregivers; e. The proposed sales record form, demonstrating a place to record the name of the purchaser, the date of the sale, and the quantity and price of cannabis sold; f. Personnel records, including national and state criminal history screening documentation for all individuals associated with the facility; samples of the personnel file documents which include job descriptions, duties, authority, responsibilities, qualifications, and supervisory information; employment applications; employment contracts; records of disciplinary action; training curricula on federal and state confidentiality requirements, professional conduct, ethics, informational developments in the field of medical cannabis, employee safety and security, and HIPAA certification; and g. The Producer’s various policies and procedures. NMAC 7.34.4.10. 30. For calendar year 2016, the DOH has issued 35 producer licenses and license renewals. 31. Each LNPP may grow a total of no more than 450 mature female cannabis plants, seedlings and male plants. NMAC 7.34.4.8(A)(2). 32. As of June 2016, there were 26,568 individuals enrolled in the Program. 33. To gain licensure as a qualified patient, one must only submit his or her name, address, and date of birth, written certification as to the debilitating condition, and information about the primary caregiver and practitioner. See Section 26-2B-7(B). 34. When the Act was passed in 2007, there were only seven debilitating conditions which qualified patients into the Program; as of the date of this filing, there are Page 7 of 17 twenty-one debilitating conditions. The additional debilitating conditions were added by the DOH’s rule-making process. 35. The DOH conducted a study, the “Medical Cannabis Report – 2013” (“the DOH Report”), in August and September 2013 to determine the levels of medical cannabis usage and production in the Program. 36. 245 of the 698 total patients surveyed reported that they had needed more cannabis to treat their conditions in the three months prior to the survey than what they had been able to obtain through the Program. 37. The primary reason qualified patients were unable to obtain sufficient cannabis to treat their conditions was because their licensed producer was out of product. 38. The second most common reason patients were unable to obtain sufficient cannabis to treat their conditions was because it was unaffordable. 39. In the DOH Report, qualified patients described producer shortages as a common occurrence. 40. Qualified patients described exorbitant prices through the Program, up to many times the market rate “on the street.” 41. Qualified patients described being forced to decide between buying their medicine through the Program and buying it “on the street,” where it was cheaper and more reliably available. 42. On information and belief, despite the net increase in qualified patients since the inception of the Program, up to one-third of patients once qualified have declined to renew their licenses under the Program due to difficulties in the availability and high cost of cannabis. Page 8 of 17 43. Sixty-five percent of the licensed producers surveyed reported that they had run out of cannabis in the three months prior to the DOH Report. 44. The licensed providers turned patients away 6,643 total times due to a shortage in cannabis in the three-month period prior to the DOH Report. 45. To accommodate for the shortage of cannabis, almost half of the licensed producers had rationed their supply in the three months prior to the DOH Report, for a total of 6,020 times qualified patients were unable to purchase the amount of cannabis they desired for treatment of their debilitating conditions. 46. The DOH Report calculated that, to satisfy the demand of current qualified patients, its producers needed to have 5,110,726 grams of cannabis available per year. 47. Even allowing for a linear increase in production, the DOH projected that the current number of licensed producers would have only 1,019,018 grams of cannabis—less than twenty percent of the demand—available for the twelve-month period from July 2013 to June 2014. 48. In 2015, the DOH adopted new rules and regulations for, among other things, the administration of the Program, adding new LNPPs, and limiting the total number of mature cannabis plants each LNPP could grow. 49. The new rules allow each LNPP to grow up to 450 mature female cannabis plants, seedlings and male plants. 50. The DOH has stated that the purpose of the new plant limit, which had previously been only 150 plants, was to address the product shortfalls and supply limitations identified in the 2013 DOH report. Page 9 of 17 51. The selection of 450 plants as the limit for each LNPP was arbitrary. No factual, practical, scientific or economic data support this limit. 52. The great weight of the evidence regarding plant count limitations was against the selection of 450 plants. 53. The great weight of the evidence supported a plant count limit much higher than 450 plants, as will be shown below. 54. Unfortunately, the new plant limits guarantee that the Program will never allow enough cannabis to be produced to ensure an adequate supply. 55. Currently, demand for medical cannabis exceeds supply by at least 2.1 million grams (4,522 pounds). 56. By early 2018, demand is expected to exceed supply by at least 6.2 million grams (13,603 pounds). 57. To meet expected demand in 2018, each of the LNPPs would need to increase the number of plants they grow by at least 600%. 58. Among others, these factors combine to make the current plant limitation unworkable: a. At least nine LNPPs are either not currently producing cannabis at levels sufficient to meet modest patient demand, or they are not producing at all, b. On average, LNPPs are not able to grow the maximum number of plants they are allowed to grow, c. The plant limitations create artificially high production costs, and d. The plant limitations prevent LNPPs from achieving economies of scale and higher efficiencies in production. Page 10 of 17 59. Patient demand for specialized strains of cannabis and specialized cannabis products further exacerbates the medical cannabis supply crisis. 60. Compared to the time when the Act became the law, patients require cannabis in an increasingly wide variety of form, concentrations and compositions. 61. Depending on a patient’s condition, she may require an edible form of a cannabisderived product with high concentrations of one cannabis compound and low concentrations of another. 62. In order to produce the specialized products required and demanded by enrolled patients, LNPPs must grow larger amounts of cannabis plants to be able to obtain from them the required quantities of the cannabis compounds. 63. Individual enrolled patients, who are allowed to grow small quantities of cannabis for their own use, are unable to produce specialized products due to lack of equipment, experience, and raw cannabis plant material. 64. Thus, only LNPPs are able to produce the specialized products demanded by patients. 65. Thus, over time, more cannabis plant material will be needed to meet the demands of patients who use products that contain higher concentrations of one or more compounds derived from the cannabis plants. 66. In addition to severely constraining supply, the production limits cause much higher prices for cannabis than would otherwise be found in a non-constrained market. 67. While supply, under the current regulations, of cannabis in New Mexico is strictly limited, demand is not constrained and will grow rapidly over the coming years. 68. During the period from June 2015 to June 2016, the number of enrolled patients in the Program grew from 15, 265 to 26,568. Page 11 of 17 69. There are several reasons to expect that this growth will continue or accelerate. 70. New Mexico’s ageing population will continue to grow. Up to 33% of the State’s population will be over 60 years of age by 2030, which will mean a larger percentage of the State’s population will have conditions that entitle them to possess a Program card. 71. In addition to demographics, epidemiological trends will likely exacerbate demand problems. 72. Increasing numbers of patients suffering from PTSD will place enormous strains on the supply of medical cannabis. 73. Due to factors relating to income, military service, and incidents of domestic violence, New Mexico has a larger-than-average percentage of the population suffering from PTSD. 74. The rapidly growing number of patients suffering from chronic pain and who do not wish to take pharmaceutical pain killers place additional upward pressure on the supply of medical cannabis in New Mexico. 75. Increasing dosage needs will apply growing pressure on supplies of cannabis. As patients require new products with higher concentrations of cannabis compounds, the average dose per patient will increase. 76. Data from other states show that New Mexico has a lower-than-average percentage of cannabis consumed in non-flower form. This is likely to change as the number of patients grows and their demand for new products increases. Page 12 of 17 77. New Mexico has a low medical cannabis market penetration. As many as 630,000 New Mexicans have one or more qualifying condition, yet only 1.2% of the State’s population participates in the Program. 78. As public acceptance of medical cannabis increases, a greater percentage of affected persons is likely to participate in the Program. 79. Other states with medical cannabis programs have higher penetration rates than New Mexico. 80. A study and economic model completed in August 2016 estimates that coming changes in demand, market penetration, public acceptance of medical cannabis, growing techniques, processes for extraction of cannabis compounds, and methods to produce additional products will cause a supply deficit of 6.2 million grams by the first quarter of 2018. 81. The study also found that there will need to be between 26,698 and 37,620 plants under cultivation in New Mexico to meet the expected demand. 82. The Act requires, by its plain meaning and by implication, that the LNPPs grow and distribute an amount of cannabis large enough to ensure an uninterrupted adequate supply to the patients enrolled in the Program. 83. The Act does not require the Defendants to establish limits on the number of cannabis plants grown and cultivated by LNPPs. 84. Contrary to the mandate of the Lynn and Erin Compassionate Use Act, the SecretaryDesignate is failing to ensure an adequate cannabis supply for qualified patients to treat their debilitating conditions. Page 13 of 17 85. Even if fully implemented, the number of plants and licenses allowed by the Defendants will be woefully insufficient to ensure an adequate supply. 86. Unless the arbitrary plant count is eliminated or greatly increased, by at least 600%, there will be persistent and ongoing shortages of medical cannabis in New Mexico for the foreseeable future. 87. Recognizing the serious problems caused by arbitrary plant count limits, other neighboring states have either eliminated plant count limits, or they have adopted limits that are tied to the number of patients enrolled in the program. The latter approach gives reasonable limits to the number of plants grown, while also allowing producers to meet demand as more patients enroll in medical cannabis programs. Count One: Declaratory Judgment as to the Act 88. All allegations found in paragraphs 1-87 are realleged and incorporated here by reference. 89. There exists an actual case and controversy between the Plaintiffs and the Defendants regarding the Defendants’ creation and enforcement of rules promulgated by the Department. 90. NMTO, Ms. Sena, and A.N. are suffering direct and immediate injury as a result of the Defendants’ enforcement of the rules at issue in this case. 91. Under the current rules promulgated by the Defendants, NMTO is not allowed to produce the amount of medical cannabis it wishes to produce to meet patient demand. 92. Under the current rules promulgated by the Defendants, NMTO is not allowed to produce the amount of medical cannabis it would be able to produce if the plant limit were not in place. Page 14 of 17 93. NMTO wishes to meet more patient demand, supply a broader range of products, and offer a greater diversity of varieties of medical cannabis products but cannot due to the Defendants’ regulations. 94. NMTO wishes to produce Haleigh’s Hope in a quantity that would give A.N. and Ms. Sena an adequate supply but cannot due to the plant limitations imposed by the Defendants. 95. The Defendants’ enforcement of the plant count limitation against NMTO causes injury by forcing NMTO, in order to attempt to meet patient demand, to acquire cannabis and cannabis products from other LNPPs at prices and costs much higher than would be incurred if NMTO could grow more cannabis plants itself. 96. The injuries to NMTO described in this complaint are ongoing with no hope of dissipation. 97. NMTO has, on multiple occasions, sought the permission of the Defendants to grow more than 450 plants; these requests have been rejected. 98. NMTO has asked for the Defendants’ permission to grow additional plants to meet the needs of certain specific patients; the requests have been rejected. 99. The Defendants have told NMTO that they will not increase the number of plants that LNPPs may grown and have no plans to increase the limit in the future. 100. This controversy is ripe for a decision by the Court because the rule at issue has been enforced against NMTO. 101. This controversy is ripe for a decision by the Court because the rule at issue has been enforced to the detriment and injury of A.N. and Ms. Sena. Page 15 of 17 102. This controversy is ripe for a decision by the Court because enforcement of the rule at issue has caused injury to A.N. and Ms. Sena by limiting their ability to have an adequate supply of the Haleigh’s Hope that A.N. requires. 103. A.N. and Ms. Sena are injured by having to pay prices for the cannabis product they need that are much higher than they would pay if New Mexico’s LNPPs could produce more plants. 104. A.N. and Ms. Sena are injured by having to endure product shortages or product unavailability, which injures A.N. by slowing her recovery and putting her at risk of serious seizures. 105. The administrative action that resulted in the challenged rule has concluded. 106. The Court may declare, on facts that are fully developed and on purely legal grounds, that the Defendants rules will not allow for an adequate supply of medical cannabis to be produced. 107. No specialized fact-finding will be required for the Court to make that determination. 108. There is no exclusive statutory remedy available to the Plaintiffs in this matter. WHEREFORE, the Plaintiffs respectfully request that the Court enter judgement in their favor and against the Defendants, holding that the current plant limitation is arbitrary. The Plaintiffs further respectfully request that the Court find that the current plant count limit should be eliminated or greatly increased so that New Mexico’s LNPP’s may produce an adequate supply of medical cannabis to meet the demands of New Mexico’s patients. The Plaintiffs also respectfully request that the Court find that the Defendants must satisfy their obligation to ensure an adequate supply of medical cannabis in New Mexico by allowing New Mexico’s LNPPs to Page 16 of 17 grow medical cannabis in a manner and quantity they believe to be necessary to ensure an adequate supply. Finally, the Plaintiffs request that the Court award them their costs of action and reasonable attorneys’ fees. Respectfully Submitted, Egolf + Ferlic + Harwood, LLC By:________________________ Brian Egolf 123 W. San Francisco Street, Second Floor Santa Fe, New Mexico 87501 (505) 986-9641 Brian@EgolfLaw.com Page 17 of 17