vahahealth
Jan 06, 2021Suzanne Sisley, et al. v. Drug Enforcement Administration, et al., 20-71433 (9th Cir.)
Summary: On May 21, 2020 Petitioners Sue Sisley, Scottsdale Research Institute, Field to Healed, and three veterans—Lorenzo Sullivan, Kendric Speagle, and Gary Hess—petitioned the Ninth Circuit for review of DEA’s decision to deny a petition to institute rulemaking. DEA’s sole basis for that denial was its reassertion of a 2016 order denying petitions brought by Rhode Island and Washington. The 2016 denial, in turn, reasserts a 1992 interpretation of the Controlled Substances Act that established DEA’s standard for determining whether a drug has a “currently accepted medical use in treatment in the United States.” 21 U.S.C. § 812(b)(1)(B).
We are challenging DEA’s interpretation of the statutory phrase. We are also challenging whether, because of international treaty obligations, DEA is required to place marijuana either into Schedule I or Schedule II. We contend that the relevant statute, 21 U.S.C. § 811(d), effectively subordinates domestic law to the views of international organizations, rendering it an unconstitutional delegation of legislative authority that violates separation of powers principles.
Our opening brief is due August 10, 2020. We would appreciate intervention or amicus support in our case. Who to Contact: Matthew Zorn (mzorn@yettercoleman.com) and Shane Pennington
(spennington@yettercoleman.com) are counsel for Petitioners.
Why This Suit Is Important: Our lawsuit has the potential to resolve many of the most vexing problems associated with federal regulation of marijuana today. By no means is it a panacea, but moving marijuana to Schedule III would:
� Resolve the Catch-22. Marijuana remains a Schedule I drug because, under the agency’s interpretation of “no currently accepted medical use in treatment,” nobody can demonstrate the safety and efficacy of marijuana in treatment. And because nobody has been able to demonstrate the safety/efficacy because of marijuana, it remains in Schedule I. Moving marijuana to Schedule III would eliminate this catch-22. It would allow DEA to approve additional cultivators, notwithstanding treaty obligations, and permit researchers to examine the safety/efficacy of dispensary-quality marijuana. Simply put, it would allow scientists to study local, homegrown bud.
� VA access and veterans’ benefits. Because marijuana is a Schedule I drug—illegal for any purpose under federal law—the Department of Veterans Affairs (VA) takes a hands-off approach. Moving marijuana to Schedule III would make it possible for the VA to discuss marijuana with veterans. It would also allow veterans to work in the medicinal marijuana industry without jeopardizing benefits and pensions.
� 280E business issues. Moving marijuana to Schedule III would resolve 280E tax issues.
� Schedule III opens the door for doctors to prescribe marijuana as medicine. Although marijuana would not be an FDA-approved medicine, pure intrastate use of marijuana is not regulated by FDA.
� State grant money. Many states have had substantial federal grant money taken away because it would go toward medical marijuana programs. That ends with rescheduling.
� Harmonize federal employment/disability laws with state medical marijuana laws.
� Enhance state autonomy over drug research and regulation. Interpreting the statute correctly would mean recognizing the primary role states play in protecting the health and welfare of citizens and determining the legitimate medical uses of drugs. This would have a broad impact going forward. For example, a state may decide it wants to investigate psilocybin as a treatment of PTSD. A favorable ruling here would lay the groundwork for rescheduling psilocybin, which would allow state physicians to prescribe psilocybin without having to go through the FDA-approval process. Reinterpreting “no currently accepted medical use” is essential to achieving the Act’s cooperative federalism regime.
� Reduce stigma. Taking marijuana out of Schedule I would mean recognizing its medicinal value and allowing sick people to obtain marijuana without being branded as felons under federal law.
Why Will We Succeed? We will succeed where others have failed because we have a different approach. First, we have raised the issue in a procedurally proper manner. Second, we have the perfect mix of petitioners to tell a compelling story. Third, we are making the right arguments—arguments that no one has made before—at the right moment in time.
Support from a state would significantly enhance our case’s profile and chances of success.
� Right Petitioners: Dr. Sue Sisley, Scottsdale Research Institute, Field to Healed, and three esteemed veterans. Over the past year, we have worked hard to develop a compelling narrative. For over a decade, Dr. Sisley has fought for the opportunity to conduct robust clinical trials with cannabis to treat treatment-resistant PTSD in veterans. Bureaucracy and arcane regulations, however, have stonewalled her efforts at every turn. To say that Dr. Sisley has exhausted the administrative process is an understatement.
Most recently, dissatisfied with the sub-par marijuana she received for research from the federal government by way of the University of Mississippi, in 2016, Dr. Sisley applied to cultivate marijuana for her own clinical trials. Her application is still pending. In June 2019, we filed a petition for mandamus in the D.C. Circuit, which ultimately spurred DEA to process her application along with those of all other applicants. Then, in March 2020, DEA announced new rules to process applications in the middle of a global pandemic. We sued again and ultimately obtained a secret memo from DOJ’s Office of Legal Counsel (OLC) instructing DEA not to process the applications. OLC wrote the memo nearly two years ago. Until our lawsuit, however, DOJ and DEA had kept it hidden from the public and Congress despite repeated demands from lawmakers from both sides of the aisle demanding an explanation for DEA’s refusal to make good on its 2016 promise to increase the number of manufacturers of marijuana for research.
Dr. Sisley and SRI are perfectly positioned to cast our legal arguments in a sympathetic light backed by a dramatic and compelling narrative. They have scrupulously complied with all relevant laws, but two federal agencies—DEA and DOJ—have worked in secret to thwart their efforts at every juncture, even violating petitioners’ due process rights. Their plight demonstrates why judicial intervention is necessary—indeed long overdue. And our veteran petitioners help emphasize that real human consequences that hang in the balance.
� Right Arguments: We will explain the facts and then stick with correct and persuasive legal arguments. Unlike past petitioners who have failed to achieve similar relief, we do not intend to rehash the drug war or challenge the agency on its turf. Instead, our arguments will draw on well- established tools of statutory construction and important recent pronouncements from the Supreme Court altering the controlling administrative-law standards. Even better, compelling legislative history reinforces our statutory argument.
We will also argue that 21 U.S.C. § 811(d) is an unconstitutional delegation of legislative authority. In brief, the statute creates a problematic “double delegation” that raises constitutional issues at
both steps. First, the statute effectively outsources the creation of domestic law to international organizations. Second, it entrusts the Attorney General to execute these obligations with no standard or guiding principle to confine his discretion. We think each step raises constitutional issues, but their combined effect is especially problematic.
We are happy to discuss these arguments and the case law that we believe supports them in more detail. In recent Terms, the Supreme Court has shown increasing interest in reining in both Chevron deference and the non-delegation doctrine, and we believe our case squarely tees up both issues in a context that will be attractive to Justices on both sides of the Court’s perceived political divide. Notably, a ruling in our favor from the Ninth Circuit would create a clear circuit split as well.
We think our recent litigation successes against DEA/DOJ demonstrate that win or lose, our current lawsuit would be a catalyst for change and for putting additional pressure on Congress/DEA.
Political Importance: This case will also provide a powerful platform to criticize or pressure the Trump Administration during an election year. The Controlled Substances Act is one of the few places where the executive branch has broad and almost unfettered authority to cut regulatory red tape to facilitate necessary changes. And yet, this administration—to the great detriment of the states, our Nation’s veterans, and sick individuals across the country—has done nothing. Worse, it has impeded cannabis research with draconian regulations, due process violations, and secret OLC memos. Agency lawmaking in secret is anathema to the rule of law and the transparency and public-participation values at the heart of the Administrative Procedure Act. And now, the administration claims it cannot move forward with the research program because of an international treaty—the first time this administration has allowed international obligations to thwart an America First policy.
More than 90% of the country supports medical marijuana. Supporting this lawsuit could be used as (yet another) way to paint the Trump Administration as out-of-step with the American people.
Legal Team
� Matthew Zorn (mzorn@yettercoleman.com). Matt’s practice focuses on complex commercial litigation, representing clients in IP, contract, and regulatory litigation in federal and state court. He has significant expertise in federal jurisdiction and procedure. Matt is a 2012 graduate of Columbia Law School. Before joining the Yetter Coleman, Matt was a judicial clerk to the Hon. Rodney Gilstrap, U.S. District Judge for the Eastern District of Texas, helping manage one of the busiest civil trial dockets in the country. Before then he was a litigator with Paul, Weiss in NYC.
� Shane Pennington (spennington@yettercoleman.com) Shane’s practice focuses on regulatory litigation and appeals in a diverse array of industries, including energy, shipping, aviation, pharmaceuticals, and healthcare, particularly challenges to federal agency action under the Administrative Procedure Act. Shane is a 2010 graduate of University of Texas law school. After graduation, Shane clerked for then-Chief Judge Sentelle on the U.S. Court of Appeals for the D.C. Circuit, Judge Elrod on the U.S. Court of Appeals for the Fifth Circuit, and Royce Lamberth on the U.S. District Court for the District of Columbia. Shane practiced at Baker Botts for three years before joining Yetter Coleman.
Source : https://www.change.org/p/support-our-veterans/u/26960296