Food and Drug Law Commons^™

Selective Patronage, Omari Scott Simmons

Seattle University Law Review

Contemporary academic corporate governance narratives have a blind spot. They focus on institutions, rules, regulations, processes, procedures, intermediaries, and market forces. Yet, missing in this narrative, is the impact of corporate leadership. Ignoring the “black box” of corporate leadership, particularly individual actors, renders an incomplete descriptive assessment as well as potential miscalculations. The examination of key historical figures and their corporate activism provides an important lens through which to identify potential challenges and opportunities related to the contemporary ESG movement.

Generally, this essay examines corporate leadership’s potential to address socio-political issues through the prism of Civil Rights Movement activism. Specifically, …

Promoting Corporate Diversity: The Uncertain Role Of Institutional Investors, Jill Fisch

Seattle University Law Review

Two developments are having an impact on corporate decisions. One is the increased engagement by institutional intermediaries and a shift in the focus of that engagement from corporate governance to environmental and social issues. The other is a heightened societal awareness of diversity, equity, and inclusion (DEI) issues, particularly the importance of diversity in corporate leadership. This Article considers the intersection between the two. It describes how institutional investors have focused their attention on increasing diversity in corporate leadership, the potential motivations for that focus, and the impact of that focus, to date. It highlights the tensions that result from …

America’S Hidden Citizens: The Untold Stories Of The Unconscionable Deportations Of Its International Adoptees, Halley Cody

Seattle University Law Review

This Note addresses how the U.S. should rectify the harms it has perpetrated on non-citizen adoptees by amending the current deportation statutes to prevent their deportation. Part I addresses the history of adoption in the U.S. and related effects on immigration law. Part II highlights the stories of Adam Crapser and Philip Clay, who were adopted by American families who failed to naturalize them as minors, and who were subsequently deported after they sustained criminal records. Part III examines the policy goals behind deportation as a consequence of criminal convictions, as well as remedies instituted to prevent unwarranted deportation and …

Inadequate Privacy: The Necessity Of Hipaa Reform In A Post-Dobbs World, Katherine Robertson

Seattle University Law Review

Part I of this Comment will provide an overview of HIPAA and the legal impacts of Dobbs. Part II will discuss the anticipatory response to the impacts of Dobbs on PHI by addressing the response from (1) the states, (2) the Biden Administration, and (3) the medical field. Part III will discuss the loopholes that exist in HIPAA and further address the potential impacts on individuals and the medical field if reform does not occur. Finally, Part IV will argue that the reform of HIPAA is the best avenue for protecting PHI related to reproductive healthcare.

On The Appeal Of Drug Patent Challenges, Charles Duan

American University Law Review

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation …

Regulating Organic, Sarah J. Morath

American University Law Review

Even highly regulated labels, such as the organic label, have the potential for greenwashing. As recently as January 2023, a grain seller was indicted in federal court for a $43 million scheme that involved the sale of non-organic grain as USDA-certified organic. But today’s organic market is also full of sellers who follow the current federal organic regulations but fail to demonstrate the spirit of the organic movement—forgoing soil, animal welfare, and community for profit. I call this nuanced form of greenwashing quasi-greenwashing. It arises when a business complies with a rule or standard but takes advantage of consumer misunderstanding …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

Law Student Publications

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …

Universal Forms Of Influence: Support For Women On Boards, Cindy A. Schipani, Paula J. Caproni

Seattle University Law Review

There are various efforts underway to increase gender diversity on corporate boards, including legislation in California, a recent SEC approved comply or explain rule for companies listed on the Nasdaq stock exchange, and efforts by institutional investors such as State Street and BlackRock to recognize the value diversity brings to corporate decisionmaking. Although some of these efforts are being contested in the courts, many companies have begun to comply with these initiatives.

This Article is organized as follows. Part I provides an overview of several efforts to increase gender diversity on boards along with numerous research studies showcasing the benefits …

“Statistics Are Human Beings With The Tears Wiped Away”: Utilizing Data To Develop Strategies To Reduce The Number Of Native Americans Who Go Missing, Lori Mcpherson, Sarah Blazucki

Seattle University Law Review

On New Year’s Eve night, 2019, sixteen-year-old Selena Shelley Faye Not Afraid attended a party in Billings, Montana, about fifty miles west of her home in Hardin, Montana, near the Crow Reservation. A junior at the local high school, she was active in her community. The party carried over until the next day, and she caught a ride back toward home with friends in a van the following afternoon. When the van stopped at an interstate rest stop, Selena got out but never made it back to the van. The friends reported her missing to the police and indicated they …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

#Metoo And The Corporation In Popular Culture, Brenda Cossman

Seattle University Law Review

#MeToo’s initial virtual explosion in the fall of 2017 was very much about Hollywood, with famous actresses speaking out against famous producers, media moguls and celebrities, exposing the ubiquity of sexual harassment and sexual violence in and around the entertainment industry. Since then, #MeToo has made its way into Hollywood representations without much irony. Films and television shows have explicitly taken up the #MeToo themes, exploring issues of sexual harassment and violence and its afterlives. Many television shows, from the relaunched version of Murphy Brown to Brooklyn Nine-Nine to The Good Fight have incorporated #MeToo themes into episodes exploring the …

A Synthesis Of The Science And Law Relating To Eyewitness Misidentifications And Recommendations For How Police And Courts Can Reduce Wrongful Convictions Based On Them, Henry F. Fradella

Seattle University Law Review

The empirical literature on perception and memory consistently demonstrates the pitfalls of eyewitness identifications. Exoneration data lend external validity to these studies. With the goal of informing law enforcement officers, prosecutors, criminal defense attorneys, judges, and judicial law clerks about what they can do to reduce wrongful convictions based on misidentifications, this Article presents a synthesis of the scientific knowledge relevant to how perception and memory affect the (un)reliability of eyewitness identifications. The Article situates that body of knowledge within the context of leading case law. The Article then summarizes the most current recommendations for how law enforcement personnel should—and …

Preempting State Prevention: How Fda Regulation Ensures Access To Abortion Medication, Jared Shea

Mitchell Hamline Law Review

No abstract provided.

Gag With Malice, Shaakirrah R. Sanders

Washington and Lee Law Review

This Article brings agriculture privacy and other commercial gagging laws into the ongoing debate on the First Amendment actual malice rule announced in New York Times v. Sullivan. Despite a resurgence in contemporary jurisprudence, Justices Clarence Thomas and Neil Gorsuch have recently questioned the wisdom and viability of Sullivan, which originally applied actual malice to state law defamation claims brought by public officials. The Court later extended the actual malice rule to public figures, to claims for infliction of emotional distress, and—as discussed in this Article—to claims for invasion of privacy and to issues of public importance or concern.

United …

Nestlé V. Doe: A Death Knell To Corporate Human Rights Accountability?, Phillip Ayers

Seattle University Law Review

The Supreme Court in Nestlé v. Doe held that foreign plaintiffs who claimed to be victims of overseas tortious conduct by corporate defendants had no jurisdiction to sue in federal courts using the Alien Tort Statute. This Comment looks at the history of the Alien Tort Statute, from its inspiration, long dormancy, and recent reinvigoration beginning in the 1980s. The Comment then explores the background of Nestlé and its issues with child slavery in its cocoa supply chain. From there, the Comment analyzes the Nestlé v. Doe decision, and posits an alternative outcome. Finally, this Comment looks for a new …

Cryptic Patent Reform Through The Inflation Reduction Act., Arti K. Rai, Rachel E. Sachs, Price W. Nicholson

Articles

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

The Disrupted Path To Becoming Easy, Breezy, Beautiful: How Companies Are Deceiving Consumers With Their Animal Testing Products, Wendy Chao

University of San Francisco Law Review

No abstract provided.

Fight For Your Life: A Study Of Fairness In The Ultimate Fighting Championship's Anti-Doping Policy Appeals Process, Brandon Hamroff

Cardozo Journal of Conflict Resolution

No abstract provided.

Pacifying Professional Negligence Disputes - The Prospective Path For Mediation Within The Psilocybin Industry, Miranda Sapoznik

Cardozo Journal of Conflict Resolution

No abstract provided.

Developing American Wine Law – Lessons From European Wine Regulation In The Face Of Climate Change And Growing Demand, Kyle Amendt Shimomura

Emory International Law Review

No abstract provided.

Corporate Governance And Gender Equality: A Study Of Comply-Or-Explain Disclosure Regulation, Aaron A. Dhir, Sarah Kaplan, Maria Arabella Robles

Seattle University Law Review

In 2020, the Nasdaq Stock Market filed a proposal with the U.S. Securities and Exchange Commission seeking permission to adopt a board diversity-related disclosure requirement for its listed companies. In 2021, the SEC approved the proposal, thus entrenching Nasdaq’s position as the most significant stock exchange to date to mandate listing rules that reflect the intention of diversifying corporate boardrooms. Nasdaq’s movement into the diversity space is not the first attempt to address homogeneous boards in the U.S. In 2009, the SEC adopted a rule requiring publicly traded firms to report on whether they consider diversity in identifying director nominees. …

Judicial Ethics And The Eradication Of Racism, Dontay Proctor-Mills

Seattle University Law Review

In 2020, the Washington Supreme Court entrusted the legal community with working to eradicate racism from its legal system. Soon after, Washington’s Commission on Judicial Conduct (hereinafter the Commission) received a complaint about a bus ad for North Seattle College featuring King County Superior Court Judge David Keenan. Along with a photo of Judge Keenan’s face, the ad included the following language: “A Superior Court Judge, David Keenan got into law in part to advocate for marginalized communities. David’s changing the world. He started at North.” The Commission admonished Judge Keenan for violating the Code of Judicial Conduct, in part …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Why Corporate Boards Should Include Lgbtq+ People, Jeremy Mcclane, Darren Rosenblum

Seattle University Law Review

Corporate boardrooms sit at the heart of most of society’s most consequential decisions but fall far short of the diversity of our society. The current movement toward board diversification aims to remedy the underrepresentation of marginalized groups on corporate boards. More recently, some efforts have included LGBTQ+ people, even though the basis for their inclusion on corporate boards remains largely unstated. This Article examines both the normative and instrumental bases for LGBTQ+ inclusion in board diversity initiatives, articulating unspoken assumptions and linking LGBTQ+ people to the broader inclusion effort. In so doing, it begins to surface the unique issues LGBTQ+ …

Criminality And Inequity Under Canada's Legalization Of Cannabis: A Study Of Vancouver's Downtown Eastside, Stephanie Lake, Margot Young

All Faculty Publications

The origin of this essay reminds us of the importance of interdisciplinary collaboration to the development and assessment of public policy. It also demonstrates the serendipitous beginnings of many interesting inquiries. This collaboration was thus fortuitous: authors Lake and Young met during Lake’s doctoral dissertation defence. Young was on the examining committee. Lake presented a series of epidemiological studies (three of which are summarized below) involving the use of cannabis for therapeutic and harm reduction purposes among marginalized people who use drugs (PWUD) in Vancouver. Young’s lines of questioning involving the legal implications of Lake’s findings spurred the idea to …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

Opening A Federal Reserve Account, Julie Andersen Hill

Articles

To open bank accounts, new customers provide personal information and make a deposit. Within a few minutes (or perhaps a few days), new customers get access to payment services. For many years, the process financial institutions used to open accounts at FederalReserve Banks was similar. Eligible banks filled out a one-page form and within a week received an account allowing them access to the FederalReserve's payment systems. Recently, however, Federal Reserve Banks have spent years considering account requests from novel banks.

This Article examines the Federal Reserve's process for evaluating requests for accounts. Using interviews, court documents, and other sources, …

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

All Faculty Scholarship

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under …

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …