Krumm v. Holder, 13cv0562 RB/SMV

REVEREND BRYAN A. KRUMM, CNP, Plaintiff, v. ERIC HOLDER, Attorney General of the United States;MICHELE LEONHART, Administrator of the United StatesDrug Enforcement Administration;KATHLEEN SEBELIUS, Secretary United States Departmentof Health and Human Services;FRANCIS S. COLLINS, M.D., Director of the National Institutes of Health;NORA D. VOLKOW, M.D., Director of the National Institute on Drug Abuse;STEVEN YARBROUGH, Acting United States Attorney forthe District of New Mexico, Defendants.

No. 13cv0562 RB/SMV

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW MEXICO

March 19, 2014

MEMORANDUM OPINION AND ORDER

THIS MATTER comes before the Court on the Defendants' Motion to Dismiss, filed September 4, 2013 [Doc. 16]. Having considered the parties' submissions and the relevant law, the Court will grant the motion.

I. BACKGROUND

For the past 16 years, Plaintiff, who states that he is the "Director of New Mexicans for Compassionate Use, and Bishop of Medicine for the Zen Zion Coptic Orthodox Church," Compl. at 4, has repeatedly challenged the validity and application of federal laws related to the smoking and possession of marijuana. Marijuana is classified under Schedule I of the Controlled Substances Act ("CSA"), 21 U.S.C. §§ 801-971, thus its use and possession are criminalized under federal law. The Attorney General, who has delegated this responsibility to the Drug Enforcement Administration ("DEA"), may modify placement of a substance on the drugschedules by relying on medical and scientific expertise provided by the Department of Health and Human Services ("DHHS") after information has been collected in regard to eight factors. See 21 U.S.C. §§ 811-12; 28 C.F.R. §§ 0.100(b) & 0.104, Appendix to Subpart R, sec. 12; 21 C.F.R. § 1308.43(d); Gonzales v. Oregon, 546 U.S. 243, 243 (2006) ("The Attorney General may add, remove, or reschedule substances only after making particular findings, and on scientific and medical matters, he must accept the findings of the Secretary of Health and Human Services . . ."). Americans for Safe Access v. DEA, 706 F.3d 438, 441 (D.C. Cir. 2013). If, after considering all studies, evaluations, recommendations, and other relevant data, the Administrator finds "substantial evidence" that the scheduling of a drug should be modified, the Administrator must initiate appropriate rulemaking proceedings. See 21 U.S.C. § 811(b); 21 C.F.R. § 1308.43(e). Judicial review of any rescheduling decision is exclusively committed to the jurisdiction of the Courts of Appeals. See 21 U.S.C. § 877. Nevertheless, Plaintiff has repeatedly attempted to circumvent this statutory process by bringing suit in this and other district courts to force the rescheduling of marijuana by judicial fiat.

In 1998 Krumm was one of about 160 named plaintiffs who raised various challenges to the CSA as it relates to smoking marijuana for medical purposes, and the Government's application of that Act. See Kuromiya v. United States, 37 F. Supp. 2d 717 (E.D. Pa. March 10, 1999). In response to Krumm's and the other plaintiffs' arguments, the district court held that the CSA is a valid exercise of Congress' powers under the commerce clause; that the sections of the CSA that prohibit marijuana use do not violate the Ninth or Tenth Amendments; that the CSA does not violate the plaintiffs' right to privacy; and that the placement of marijuana in a different drug category from a synthetic drug containing marijuana's active ingredient does not violate equal protection. See id. The Court held that "there is no fundamental right of privacy toselect one's medical treatment without regard to criminal laws, and courts have consequently applied only rational review to regulations affecting these matters." Id. at 726. The court subsequently dismissed the plaintiffs' remaining claim, which was based on their argument that equal-protection principles were violated when the government ended an experimental federal "compassionate use program," thereby excluding the plaintiffs from the program, in circumstances in which a few long-term participants were allowed to remain in the program and were furnished with marijuana. See Kuromiya v. United States, 78 F. Supp. 2d 367 (E.D. Pa. Dec. 1, 1999). After reviewing the summary-judgment record, the Court held that "the government had a rational basis for its decision not to supply marijuana to the plaintiffs [including Krumm] through the compassionate use program." Id. at 368. Although the plaintiffs initially filed an appeal, their appeal was ultimately dismissed.

In 2002, Krumm signed a petition for reclassification of marijuana submitted to the DEA by another individual, Jon Gettman, on behalf of the Coalition to Reschedule Cannabis.

In 2008, again represented by counsel, Krumm brought suit for declaratory and injunctive relief in this Court, complaining that the DEA still had not acted on the Gettman petition. He argued that scheduling of marijuana as a prohibited substance is unlawful because it "has accepted medical use in treatment in 12 states," and alleged that "Krumm's primary care physician has . . . referred him to the Lynn Pierson Therapeutic Research Program, through which Krumm would be able to personally use medically prescribed marijuana." Krumm v. Holder, No. 8cv1056, 2009 WL 1563381, *2 (D. N.M. May 27, 2009) (Krumm I). As in the case at bar, Krumm sought

preliminary and permanent injunctions forbidding . . . interfere[ence] with State medical cannabis programs; (ii) a judgment declaring that the CSA's regulatory scheme does not permit marijuana to remain in Schedule I; (iii) a judgment declaring that the principle of equal protection protects states' rights to produce,possess, distribute, and use marijuana for medical purposes; [and] (iv) an order to the [DEA] to take marijuana out of Schedule I and to place marijuana into an appropriate schedule.

Id. at *3-4; compare Compl. at ¶ 84. In addition, Krumm now seeks a writ of mandamus to force the DHHS to "conduct a thorough evaluation of Cannabis using a panel which shall include public members with expertise on Medical Cannabis and familiarity with patients in State Medical Cannabis programs, to determine which schedule, if any, cannabis should be placed;" a writ of mandamus to force the "NIH to fund FDA approved studies investigating the therapeutic value of cannabis;" and a writ of mandamus to force the "NIDA to supply cannabis to FDA approved studies investigating the therapeutic effect of cannabis." Compl. at ¶ 84.

After extensive briefing and hearings, this Court dismissed Krumm I for lack of subject-matter jurisdiction, holding that "[t]he nature of the administrative process that Congress provides for rescheduling in the CSA, viewed in the context of the overall administrative scheme for dealing with controlled substances, reveals that Congress intended the process set forth in 21 U.S.C. § 811 to be the exclusive means by which an interested party can seek rescheduling." 2009 WL 1563381, *8. Assuming that Krumm could have "piggybacked" onto Gettman's petition to the DEA, the Court held that, because no ruling had yet been made regarding that petition,"even if he is a party, he has not exhausted his administrative remedies." Id. at *10. The Court held that it does "not have subject-matter jurisdiction in this case" because Krumm "must exhaust his administrative remedies by following the procedures prescribed in the CSA", and that "once Krumm has exhausted the administrative process, he must seek judicial review, not in this or any other federal district court, but rather in the appropriate court of appeals." Id. at 13. Krumm did not appeal from that final order, and it is binding upon him.

In 2010, Krumm filed his own petition for rescheduling of marijuana with the DEA. The DEA has not yet ruled on that petition. Compl. ¶¶ 22-24. The DEA recently denied Gettman's petition. Compl. ¶ 29; see 76 Fed. Reg. 40552 (July 8, 2011) (Denial of Petition to Initiate Proceedings to Reschedule Marijuana). The Coalition sought review in the United States Court of Appeals for the District of Columbia Circuit, contending that the DEA's denial was arbitrary and capricious. See Americans for Safe Access v. D.E.A., 706 F.3d 438, 440 (D.C. Cir. 2011), cert. denied, 134 S. Ct. 267 (Oct 07, 2013). The D.C. Circuit noted that the DEA's regulations "define 'currently accepted medical use' to require" a showing of five factors. Id. at 391. Those factors are: "(1) The drug's chemistry must be known and reproducible; (2) There must be adequate safety studies; (3) There must be adequate and well-controlled studies proving efficacy; (4) The drug must be accepted by qualified experts; and (5) The scientific evidence must be widely available." Id. at 449 (internal quotation marks omitted). In conducting its investigation, the DHHS reported to the DEA that the five-part test was not satisfied because

marijuana's chemistry was not "known and reproducible" as there had not been "a complete scientific analysis" of its components. Id. at 40,552, 40,560. In addition, although there was ongoing research, there were no studies of sufficient quality to assess "the efficacy and full safety profile of marijuana for any medical condition." Id. at 40,560. Further, there was "a material conflict of opinion among experts" as to medical safety and efficacy, thereby precluding a finding that qualified experts accepted marijuana as a medicine. Id. Additionally, the raw research data typically were not available in a format that would allow "adequate scientific scrutiny of whether the data demonstrate safety or efficacy."

Id. at 442. The "DHHS' recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. 21 U.S.C. § 811(b)." Id. at 450. The DC Circuit concluded that the DEA's denial was not arbitrary or capricious. Id. at 441.

In his pro-se Complaint at bar, despite this Court's prior rulings that it does not have subject-matter...