Food and Drug Law Commons^™

Going Forward: The Role Of Affirmative Action, Race, And Diversity In University Admissions And The Broader Construction Of Society, Steven W. Bender

Seattle University Law Review

The third annual EPOCH symposium, a partnership between the Seattle University Law Review and the Black Law Student Association took place in late summer 2023 at the Seattle University School of Law. It was intended to uplift and amplify Black voices and ideas, and those of allies in the legal community. Prompted by the swell of public outcry surrounding ongoing police violence against the Black community, the EPOCH partnership marked a commitment to antiracism imperatives and effectuating change for the Black community. The published symposium in this volume encompasses some, but not all, the ideas and vision detailed in the …

Memories Of An Affirmative Action Activist, Margaret E. Montoya

Seattle University Law Review

Some twenty-five years ago, the Society of American Law Teachers (SALT) led a march supporting Affirmative Action in legal education to counter the spate of litigation and other legal prohibitions that exploded during the 1990s, seeking to limit or abolish race-based measures. The march began at the San Francisco Hilton Hotel, where the Association of American Law Schools (AALS) was having its annual meeting, and proceeded to Union Square. We, the organizers of the march, did not expect the march to become an iconic event; one that would be remembered as a harbinger of a new era of activism by …

After Affirmative Action, Meera E. Deo

Seattle University Law Review

This is a time of crisis in legal education. In truth, we are in the midst of several crises. We are emerging from the COVID pandemic, a period of unprecedented upheaval where law students and law faculty alike struggled through physical challenges, mental health burdens, and decreased academic and professional success. The past few years also have seen a precipitous drop in applications to and enrollment in legal education. Simultaneously, students have been burdened with the skyrocketing costs of attending law school, taking on unmanageable levels of debt. And with the Supreme Court decision in SFFA v. Harvard, we are …

Defeat Fascism, Transform Democracy: Mapping Academic Resources, Reframing The Fundamentals, And Organizing For Collective Actions, Francisco Valdes

Seattle University Law Review

The information we gathered during 2021–2023 shows that critical faculty and other academic resources are present throughout most of U.S. legal academia. Counting only full-time faculty, our limited research identified 778 contacts in 200 schools equating to nearly four contacts on average per school. But no organized critical “core” had coalesced within legal academia or, more broadly, throughout higher education expressly dedicated to defending and advancing critical knowledge and its production up to now. And yet, as the 2021–2022 formation of the Critical (Legal) Collective (“CLC”) outlined below demonstrates, many academics sense or acknowledge the need for greater cohesion among …

Sffa V. Harvard College: Closing The Doors Of Equality In Education, Ediberto Roman

Seattle University Law Review

The United States Supreme Court’s recent combined decision ending affirmative action in Students for Fair Admissions v. Harvard College and Students for Fair Admissions v. University of North Carolina was hailed in conservative circles as the beginning of “the long road” towards racial equality. Others declared that “the opinion may begin the restoration of our nation’s constitutional colorblind legal covenant.” Another writer pronounced, “Affirmative action perpetuated racial discrimination. Its end is a huge step forward.” A Washington-based opinion page even declared: “[T]he demise of race-based affirmative action should inspire renewed commitment to the ideal of equal opportunity in America.” Despite …

Religious Freedom And Diversity Missions: Insights From Jesuit Law Deans, Anthony E. Varona, Michèle Alexandre, Michael J. Kaufman, Madeleine M. Landrieu

Seattle University Law Review

This Article is a transcript of a panel moderated by Anthony E. Varona, Dean of Seattle University School of Law. During the panel, Jesuit and religious law school deans discussed what law schools with religious missions have to add to the conversation around SFFA and the continuing role of affirmative action in higher education.

The Class Of Injuries Test: A Unifying Proposal To Determining Duty, Proximate Cause, And Superseding Cause In Negligence Claims, Judge Leonard J. Feldman, Julia Doherty

Seattle University Law Review

While there seems to be universal agreement that liability in tort cannot be unlimited, there is widespread disagreement regarding the various tests that courts utilize to limit such liability. We assume here that breach can be proven: the defendant failed to conduct themself in accordance with the salient standard of conduct (for example, failure to exercise reasonable care under all the circumstances). In the ensuing litigation, the court and jury are asked to decide several issues that each limit liability for negligence. Here, we focus on three oft-debated issues: duty, proximate cause, and superseding cause. The tests for each are …

Ai, New Technologies, And Corporate Governance: Three Phenomena, Martin Petrin

Seattle University Law Review

Artificial intelligence (AI) and other new technologies are increasingly influencing the operations, business models, and structures of companies. This Article focuses on three emerging phenomena that impact significant aspects of corporate governance and regulation: (1) perforation and blurring of firm boundaries through the ubiquitous use of externally provided AI services; (2) businesses engaging in strategic access and leveraging of critical resources held by third parties without owning them; and (3) the unusual hybrid role of online platforms between market facilitators and markets themselves. The Article explores how these phenomena challenge traditional views of firms as separate units, with technology leading …

Due Process Shaped By The Present Instead Of The Past: The Needed Reinvigoration Of A Lawrence Vision Of Due Process, Azor Cole

Seattle University Law Review

The recognition of unenumerated rights, rights implied from the text of the constitution, is a political battlefield waged through law with profound implications for all Americans. Generally, there have been two prongs for an inquiry into an unenumerated constitutional right under the Fourteenth Amendment. One is to ask whether the right to be found is objectively deeply rooted in this Nation’s history and tradition. The other is to ask whether the right to be found is fundamental to this Nation’s scheme of ordered liberty. The current Supreme Court has effectively done away with this present-day liberty analysis, saying it is …

A Meaningful Life: The Future Of Juvenile Justice In Washington After Anderson, Samuel Coren

Seattle University Law Review

Until 2022, Washington’s line of juvenile sentencing jurisprudence gave every indication of continuing along the course set by Miller v. Alabama, as Washington courts recognized that “children are different” and should not be subjected to the harshest punishments available in the criminal legal system. State v. Anderson marked a stark diversion from this course. In upholding the constitutionality of a de facto life sentence for a juvenile, the Washington Supreme Court all but rejected the well-established scientific consensus surrounding juvenile brain development and implicit racial bias. Whether this decision reflects a minor aberration or a broader trend in the court’s …

Reconciling Disjunct Cryptocurrency Securities Enforcement With Purchaser Expectations, Jacob E. Simmons

Seattle University Law Review

The Southern District of New York’s July 2023 decision in SEC v. Ripple Labs, Inc. has been touted as a monumental win for cryptocurrency purchasers and related businesses. The Ripple court held that, except institutional investor transactions, all sales of Ripple’s XRP token were not investment contracts, a class of security subject to federal securities law. The court’s ruling meant that Ripple could not be held liable for the unregistered trading of XRP beyond its sales to institutional investors. Ripple adds new insights to a pervasive policymaking dilemma addressed in this Note: is the Securities and Exchange Commission’s (SEC) regulatory …

Sneakers, The Shoes That Talk The Talk And Walk The Walk: How Jack Daniel’S Properties, Inc. V. Vip Products Left Its Footprint On Trademark Law And The Sneaker Industry, Nitya Tolani

Seattle University Law Review

As the fashion industry—including the sneaker industry housed within it—continues to go through the motions of collectively flocking out, and then collectively flocking again to the newest innovations in the world of wearables, the landscape of laws to protect and promote those innovations expands as well, mainly in the area of intellectual property law. Although copyright, trademark, and patent law can cover innovations in the fashion industry, this Note centers its analysis on trademark law. Trademark law has been through notable change in recent years because of the United States Supreme Court’s 2023 decision in Jack Daniel’s Properties, Inc. v. …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The First Amendment To The Constitution, Associational Freedom, And The Future Of The Country: Alabama’S Direct Attack On The Existence Of The Naacp, Helen J. Knowles-Gardner

Seattle University Law Review

Sixty years ago, on Wednesday, April 8, 1964, Professor Harry Kalven, Jr., gave the second of three lectures at The Ohio State University College of Law Forum. These lectures were published two years later in a book entitled The Negro & the 1st Amendment. In the second lecture, Kalven distinguished between direct and indirect threats to the associational freedom of the National Association for the Advancement of Colored People (NAACP). Kalven categorized the 1958 decision in NAACP v. Alabama ex rel. Patterson as an indirect effort to control the NAACP.

With the benefit of material obtained from numerous archival sources, …

A Blueprint To Reclaim Legal Education From External Rankers, Scott Rempell

Seattle University Law Review

The U.S. News & World Report (U.S. News) law school rankings have impacted the perceptions and behaviors of everyone in the rankings ecosystem for decades. Commentators have almost universally condemned these ordinal rankings, yet they continue to influence the legal education market, often in highly detrimental ways.

The influence of these rankings stems from legitimate market demands, for reasons that the psychology of choice literature makes clear. People want (or need) to efficiently acquire and digest information that could help them make consequential decisions. At a time when consumers of law school information did not have such choice-making assistance, U.S. …

Prejudice Standards In Washington’S Appellate Courts, Andrew B. Van Winkle

Seattle University Law Review

When an appellate court finds an error to have occurred during a proceeding, the error is not yet subject to correction. In order to merit a remedy, the error must have been sufficiently prejudicial to the aggrieved party’s case. Drawing the line between correctable and non-correctable errors is not an easy task, for it often requires guessing at what was in the minds of jurors and trial judges. To cope with this task, courts have devised various rules and tests for deciding whether an error was likely prejudicial or not. These standards often go by names such as “harmless error,” …

Real-World Consequences For Online Actions: The Case For Expanding Employee Harassment Protection Via Employers’ Rights Of Action, Alexander Barnes

Seattle University Law Review

This Note argues for expanding employers’ access to legal remedies that allow them to recoup the costs of protecting their employees from swatting, doxing, and other online harassment arising from their employees’ professional activity. Part I provides a brief description and history of the online harassment problem and its potentially deadly dangers. Part II describes employers’ legal responsibility to take action to protect their employees from harassment aimed at their employees within the scope of their employment. Part III explores common legal remedies that are currently available to employers, using the state of Washington as an example. Part III also …

Foreseeability And Duty In Washington Negligence Law: Leaving The Road Less Traveled By, Leo Linder

Seattle University Law Review

Washington negligence law is a confusing labyrinth of foreseeability that not even Ariadne’s string could guide plaintiffs out of. Foreseeability is implicated in four distinct analyses, several of which overlap considerably. Doctrines that were once questions of law are now questions of fact, and vice versa. Something needs to change.

Washington has taken the novel approach of bifurcating the duty element into two parts—duty’s mere existence, which is a question of law for the court to determine; and duty’s scope, which is a question of fact handed off to the jury to determine. Foreseeability impacts both of these assessments, but …

Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai

Faculty Scholarship

This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs’ complexity, meeting the regulatory requirement of ‘high similarity with no clinically meaningful differences’ will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

On The Scales Of Private Law: Nano Contracts, Yonathan A. Arbel

Articles

Contracts are falling in scale. New contracting trends and technologies facilitate the formation of smaller scale contracts that have ephemeral duration, token stakes, and narrow scope. These nano contracts embody ephemeral interactions of minuscule value - interactions that were previously far outside the law and away from explicit markets, governed only by social norms. The rise of nano contracts can unlock new transaction types, create opportunities to build wealth, and reduce dependence on private ownership. Yet nano contracts also carry important risks, and their small scale makes them difficult to effectively regulate. At the limit, nano contracts collapse private law …

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …

Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin

Articles, Book Chapters, & Popular Press

Krieger v. Law Society of Alberta held that provincial and territorial law societies have disciplinary jurisdiction over Crown prosecutors for conduct outside of prosecutorial discretion. The reasoning in Krieger would also apply to government lawyers. The apparent consensus is that law societies rarely exercise that jurisdiction. But in those rare instances, what conduct do Canadian law societies discipline Crown prosecutors and government lawyers for? In this article, I canvass reported disciplinary decisions to demonstrate that, while law societies sometimes discipline Crown prosecutors for violations unique to those lawyers, they often do so for violations applicable to all lawyers — particularly …

Prioritizing Regional Wildlife Conservation By Rejuvenating The Western Hemisphere Convention On Nature Protection, Shade Streeter, David Hunter, William Snape Iii

Sustainable Development Law & Policy

Last year, parties to the Convention on Biological Diversity (“CBD”), representing nearly every nation, signed a milestone agreement committing, among other things, to conserve thirty percent of Earth’s lands and oceans to stave off the rapid diminution of the planet’s biodiversity. Implementing these global commitments will require not only strong domestic measures, but also enhanced regional cooperation targeting the conservation of the region’s migratory wildlife and shared resources. Although the United States is the sole major holdout from the CBD, it can still reassert its leadership in regional wildlife conservation by rejuvenating the Convention on Nature Protection and Wildlife Preservation …

Unclos, Undrip & Tartupaluk: The Grim Tale Of Hans Isle And Graense, Christopher Mark Macneill

Sustainable Development Law & Policy

“Inuit have lived in the Arctic from time immemorial.” The Arctic, in the face of climate change, has become a hot spot for exploration, resource extraction, and increased shipping and scientific activity. “[The] Inuit . . . have had a common and shared use of the sea area and the adjacent coasts” among their own communities, and contemporaneously with the world. This vast circumpolar Inuit Arctic region includes land, sea, and ice stretching from eastern Russia (Chukotka region) across the Berring Strait, to Alaska, the Canadian Arctic, and Greenland, representing an Inuit homeland known as Nunaat. Hans Isle, a small …

The Great Climate Migration: A Critique Of Global Legal Standards Of Climate-Change Caused Harm, Mariah Stephens

Sustainable Development Law & Policy

Approximately 2.4 billion people, or about forty percent of the global population, live within sixty miles (one hundred kilometers) of a coastline. The United Nations (“U.N.”) determined that “a sea level rise of half a meter could displace 1.2 million people from low-lying islands in the Caribbean Sea and the Indian and Pacific Oceans, with that number almost doubling if the sea level rises by two metres.” The U.N. also reports that “sudden weather-related hazards” have internally displaced an annual average of 21.5 million people since 2008. Within the next few decades, this number is likely to continue to increase. …

The Future Of Crypto-Asset Mining: The Inflation Reduction Act And The Need For Uniform Federal Regulation, Liz Guinan

Sustainable Development Law & Policy

Crypto-asset mining is energy-intensive and environmentally harmful, presenting challenges and opportunities for federal, state and local governments, regulators, and society as a whole. As of December 2021, the United States has thirty-eight percent of the global crypto network hash rate, which is the total amount of computational power used to mine and process crypto transactions, making the United States the world’s largest crypto-asset mining industry. The total electricity consumption of crypto-asset mining in the United States is estimated to be around 121.36 terawatt-hours (“TWh”) per year, which is equivalent to the electricity consumption of approximately 10.9 million households in the …

Editors' Note, Rachel Keylon, Meghen Sullivan

Sustainable Development Law & Policy

For more than two decades, the Sustainable Development Law and Policy Brief (“SDLP”) has published works analyzing emerging legal and policy issues within the fields of environmental, energy, sustainable development, and natural resources law. SDLP has also prioritized making space for law students in the conversation. We are honored to continue this tradition in Volume XXIII.

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …