[author: Christina Sava]
Given the massive wave of medical and adult use marijuana laws being passed across the country, the average person may think there is no longer any debate as to whether marijuana has legitimate medical applications. On June 10, 2021, however the federal Court of Appeals for the Ninth Circuit heard argument on exactly that question. The case has potential to set important precedent not just for marijuana scheduling, but also other Schedule I substances being studied for their therapeutic potential. In Sisley vs. U.S. DEA, Dr. Suzanne Sisley, an Arizona researcher, challenges the DEA’s scheduling of marijuana as a Schedule I substance, a designation that the federal Controlled Substances Act reserves for substances having no currently accepted medical use in treatment in the United States. Sisley is the president and founder of the Scottsdale Research Institute (“SRI”), a Phoenix-based clinical trial site studying the medical safety and efficacy of cannabis and its various forms of administration. SRI recently completed a federally-authorized study of medical marijuana’s potential to treat PTSD in military veterans.
SRI has challenged DEA’s cannabis policies before. In 2016, Sisley filed an application for registration with DEA to obtain permission to produce her own marijuana for research purposes. When DEA seemed to be ignoring the application, she sued DEA for its failure to act. In response, DEA finally drafted new rules to expand the number of authorized growers of marijuana for scientific research purposes, and eventually granted Sisley and a handful of other researchers approval to produce their own marijuana.
Now, Sisley and a group of disabled veterans who also join as plaintiffs want the DEA to move marijuana off of Schedule I. DEA stands firm that it has previously requested scientific and medical evaluations of marijuana from the FDA, which found that the substance has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision. Based on FDA’s recommendations, DEA has kept marijuana on Schedule I even as it expanded its availability for research purposes.
The crux of Sisley’s argument is that DEA’s five-part test for deciding whether a substance should be in Schedule I is not aligned with the intent of Congress expressed in the Controlled Substances Act. Sisley claims Congress set the bar for what constitutes “currently accepted medical use” lower than where DEA has set it via rulemaking. She further claims that Chevron deference, which has been applied to uphold DEA’s five-part test in the past, is no longer appropriate in this case, based on recent Supreme Court decisions such as Gonzales v. Oregon, where the Court held that the Attorney General cannot override a state’s decision to authorize a particular substance for the care and treatment of patients (in that case, the substances in question were drugs used during state-legal physician-assisted suicide).
Because DEA often leans on the United States’ obligations under international treaties as a justification for maintaining strict controls over marijuana production and use, Sisley’s brief also attacks U.S. law as it relates to one of these treaties: the United Nations Single Convention on Narcotic Drugs. Ratified by the U.S. in 1964, the Single Convention creates four schedules of narcotic drugs with a potential for abuse, and outlines certain restrictions on the manufacture, trade, and use of these substances based on their scheduling. It then requires signatory countries to implement domestic restrictions on the substances in alignment with the Convention. DEA’s scheduling, rescheduling, and descheduling decisions are based, in part, on whether the resulting domestic restrictions would comport with the requirements of the Single Convention. The DEA contends that marijuana, a Schedule I drug according to the Single Convention, would not have the appropriate controls within the US if it were not on Schedules I or II. Sisley asks the court to find the provision of the CSA that gives the U.S. Attorney General the power to follow the Single Convention without regard to any other findings that may be required by the CSA (such as whether a substance has a currently accepted medical use) an unconstitutional delegation of legislative power.
In response, the government moved to dismiss the case for failure to exhaust administrative remedies. Specifically, plaintiffs bring the case based on DEA’s response to a one-page, hand-written petition to remove or reschedule cannabis filed by an individual named Stephen Zyszkiewicz, who, at the time of the petition, was in prison in California for a marijuana crime. While any person may file a petition with DEA asking for rescheduling, DEA argues that, because none of the plaintiffs did that themselves, they have not exhausted their own administrative remedies and therefore do not have standing to bring the case.
Indeed, the question of standing perplexed the judges most at oral argument, where the court seemed unsure of the idea that any private party may bring a case based on anyone else’s petitions to the government. The court spent most of the time questioning Matthew Zorn, counsel for Sisley, as to the standing issue, and Zorn leaned heavily on Massachusetts v. EPA, a greenhouse gas emissions case where Massachusetts appealed EPA’s rulemaking after another party challenged the EPA to regulate greenhouse gases. Daniel Aguilar, counsel for DEA, maintained that Massachusetts did not grant private parties the same special cause of action reserved for states as “separate sovereigns.”
The case is now awaiting the Ninth Circuit’s decision. If the court finds that Sisley does not have standing to bring the case, it is unlikely to opine on the merits of the scheduling argument, putting plaintiffs back at square one. If the court decides that standing exists, its analysis of the merits could set important precedent for DEA scheduling policy not just for marijuana, but for other Schedule I controlled substances that are being studied for medical purposes such as MDMA, psilocybin, and LSD. Furthermore, plaintiffs’ argument raises an interesting point about U.S. obligations under the Single Convention, considering that the recent attempt at federal legalization, the Marijuana Opportunity Reinvestment and Expungement Act, or “MORE” Act, of 2021 seeks to completely deschedule marijuana, which would be contrary to the U.S.’s obligations under the Single Convention.
Our Tobacco Team continues to watch developments in this area closely.