Food and Drug Law Commons^™

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Recalibrating Suspicion In An Era Of Hazy Legality, Deborah Ahrens

Seattle University Law Review

After a century of employing varying levels of prohibition enforced by criminal law, the United States has entered an era where individual states are rethinking marijuana policy, and the majority of states have in some way decided to make cannabis legally available. This symposium Article will offer a description of what has happened in the past few years, as well as ideas for how jurisdictions can use the changing legal status of cannabis to reshape criminal procedure more broadly. This Article will recommend that law enforcement no longer be permitted use the smell of marijuana as a reason to search …

Marijuana Law Reform In 2020 And Beyond: Where We Are And Where We’Re Going, Sam Kamin

Seattle University Law Review

With another presidential election now looming on the horizon, both political parties and both sides of the marijuana law reform debate are once again preparing for the possibility of a seismic change in how marijuana is regulated in the United States. In this Article, I lay out the state of marijuana law and policy in the United States today with an eye toward that uncertain future. I describe the differential treatment of marijuana under state and federal law and the tensions this causes for those seeking to take advantage of marijuana law reform in the states. I analyze recent changes …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Innovating Federalism In The Life Sciences, Myrisha S. Lewis

Faculty Publications

This Article challenges the view that the US. Food and Drug Administration (FDA) has exclusive Jurisdiction over life sciences innovations. Many current and forthcoming life sciences innovations are "innovative therapies" such as gene editing, gene therapy, and regenerative stem cell treatments, which are actually "hybrids" of state and federal Jurisdiction. Thus, both state and federal Jurisdiction coexist: federal Jurisdiction exists to the extent that these medical innovations use drugs or biologics, but state Jurisdiction exists to the extent that these innovations are procedures regulated by states as the practice of medicine.

This Article argues that the regulation of numerous current …

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

The “Free Market” For Marijuana: A Sober, Clear-Eyed Analysis Of Marijuana Policy, H. Justin Pace

Lewis & Clark Law Review

Federal law prohibits the possession and sale of marijuana. At the same time, states are not only decriminalizing marijuana but also attempting to provide a regulatory apparatus for its sale. This has created a unique business environ- ment. In some ways, there is a true “free market” for marijuana in states that have legalized it—free, that is, of the legal and financial infrastructure avail- able to fully licit businesses in America.

Contracts may not be enforceable because they lack a legal purpose. Relief in bankruptcy court may not be available, either as a debtor or as a creditor. Use of …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

(Carbon) Farming Our Way Out Of Climate Change, Alexia Brunet Marks

Publications

Numerous climate-related emergencies highlight the challenges and urgency posed by climate change: the 2018 Intergovernmental Panel on Climate Change (IPCC) Report, the Global Climate Action Summit in California and international student walkouts, to name a few. While the IPCC Report sent an urgent cry to reduce total emissions and to achieve specific results—45% reduction by 2030 and net-zero emissions by 2050—reductions need to be combined with capturing and storing atmospheric carbon dioxide. Scientific studies have shown that an annual increase of 0.4% of carbon stored in soils would make it possible to stop the present increase in atmospheric CO2.

This …

Global Implementation Of Soda Taxes: Is There A Better Solution For Combatting Obesity?, Lauren Cedeno

Brooklyn Journal of International Law

As incidences of overweight and obese populations continue to increase around the world, countries are looking for ways to decrease the prevalence of this epidemic. Soda and SSB taxes have increased in prevalence as countries seek to address the health problems associated with consumption of soda and other sugary beverages. This Note explores the implementation of these taxes in Mexico, Europe, and the United States. In analyzing these taxes, this Note seeks to gain a greater understanding of whether these taxes have impacted overweight and obesity rates in the countries and municipalities that have enacted them. This Note argues that …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Forbidden Flower: How Allowing Medical Cannabis Flower In West Virginia Helps Heal Patients And The State Economy, Jordan Maddy

West Virginia Law Review

No abstract provided.

Due Process Supreme Court Appellate Division Second Department

Touro Law Review

No abstract provided.

Defining Fishing, The Slippery Seaweed Slope, Ross V. Acadian Seaplants Ltd., Rebecca P. Totten

Ocean and Coastal Law Journal

In Maine, the intertidal zone has seen many disputes over its use, access, and property rights. Recently, in Ross v. Acadian Seaplants, Ltd., the Maine Supreme Judicial Court, sitting as the Law Court, held that rockweed seaweed in the intertidal zone is owned by the upland landowner and is not part of a public easement under the public trust doctrine. The Court held harvesting rockweed is not fishing. This case will impact private and public rights and also the balance between the State's environmental and economic interests. This Comment addresses the following points: first, the characteristics of rockweed and the …

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …

A Prescription For Disaster: How Local Governments' Abuse Of Public Nuisance Claims Wrongly Elevates Courts And Litigants Into A Policy-Making Role And Subverts The Equitable Administration Of Justice, Luther J. Strange Iii

South Carolina Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Weed Whacking Through The Tenth Amendment: Navigating A Trump Administration Threat To Withhold Funding From Marijuana-Friendly States, Arlen Gharibian

Loyola of Los Angeles Law Review

The Trump administration has taken a firm stance against marijuana legalization at the state level. While an official federal policy is still pending, this Article focuses on whether the Trump administration’s threats to preventCalifornia from pursuing its duly enacted marijuana legalization law violates the Tenth Amendment. This Article then addresses how the federal government could achieve its goal while remaining within the bounds of the Constitution.

Comparative Analysis Of State Regulation Of Direct-To-Market Sales Of Finfish, Marine Affairs Institute, Roger Williams University School Of Law, James Philopena Jr.

Sea Grant Law Fellow Publications

No abstract provided.

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

A Hybrid Approach To Marijuana Federalism, Susan F. Mandiberg

Lewis & Clark Law Review

With the evident indulgence of the United States Department of Justice, states are jumping on the bandwagon of legalizing medicinal and recreational marijuana even though marijuana use is criminalized under the Federal Controlled Substances Act. The possibility that the federal government will at some point decriminalize marijuana use poses a challenge for the construction of a regulatory framework. In short, how should the states and the federal government divide regulatory responsibilities?

There has been significant academic discussion about possible regulatory frameworks to address this issue. Drawing upon existing federalism schemes in the environmental and natural resource area, this Article reviews …

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Ethical Cannabis Lawyering In California, Francis J. Mootz Iii

St. Mary's Journal on Legal Malpractice & Ethics

Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …

Selling Fish To Restaurants And The Public: A Fisher's Guide, Marine Affairs Institute, Roger Williams University School Of Law, Brynae Riggins

Sea Grant Law Fellow Publications

No abstract provided.

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 5, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fifth part of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on the back-end leakage in the state’s obligation to control both the physical flows of legalized marijuana, as well as the related fiscal flows (the proceeds of legalized marijuana sales). These flows intersect dramatically in retail-level frauds.

There are very few new proposals on how to solve the physical flow problems with consumer re-sales into the black market. Traditional …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 4, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fourth of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on retail-level frauds. It proposes a limited purpose crypto currency. At the retail level the MJ Freeway or METRC software essentially functions as a marijuana-industry-specific point of sale (POS) system. It is common in retail for different industry sectors (restaurants, hotels, convenience stores, or gasoline stations) to have market-specific POS systems that are molded to fit the unique characteristics of …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 2, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

Legalization of marijuana burdens the States with the responsibility of (a) monitoring the physical flows of marijuana through the supply chain (making sure the marijuana does not enter inter-state commerce; making sure it stays out of the hands of minors, etc.), and (b) monitoring the fiscal flows (making sure the proceeds of marijuana production do not end up in criminal hands).

The type of controls favored by the states are track and trace (TAT), or seed-to-sale (STS) systems. These systems are reasonably complex, as well as technology-intensive. Nevertheless, there are questions about whether they are adequate to the enforcement needs. …