Food and Drug Law Commons^™

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.

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 …

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 …

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

Cardozo Journal of Conflict Resolution

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+ …

How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard

Brooklyn Law Review

The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

U.S. Drug Reform: A Cultural Shift, Leionah J. Noah

St. Thomas Law Review

When a human body ingests a lethal dose of heroin, the body goes through an enormous physiological transformation. The functions of the central nervous system begin to depress, breathing is shallowed, the pulse is weakened, and the skin turns blue or gray with dark lips and fingernails. An alert person must quickly administer naloxone, an opioid antagonist, to reverse the effects of a heroin overdose, as symptoms typically begin after ten minutes. For many, however, their lives end with an overdose, despite this outcome being preventable. This paper will establish that drug overdose deaths are preventable for an entirely different …

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …

Cannabis Receiverships: The Alternative For State Legal Cannabis Businesses Seeking Financial Rehabilitation Locked Out Of Bankruptcy Court By The Controlled Substances Act, Ryan C. Griffith

Seattle University Law Review

This article explores how cannabis businesses suffer by being unable to utilize federal bankruptcy and explore state law receiverships as an alternative remedy to help cannabis businesses weather financial storms.

Part I explores the limitations and differences between a receivership and a bankruptcy. Part II discusses how state legal cannabis companies cannot seek financial rehabilitation in bankruptcy court due to cannabis being listed as a schedule I drug federally. Part III explores how receivership be used to help cannabis companies that cannot seek bankruptcy protection to financially rehabilitate themselves. Part IV details how a receiver can help a cannabis company …

Table Of Contents

Seattle University Law Review

Table of Contents

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein

Brooklyn Law Review

In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …

Don't You Know That You're Toxic? Cercla Section 113(H) Challenges, Sovereign Immunity, And Perfluoroalkyl Substances In Pennsylvania Drinking Water In Giovanni V. Navy, Stephanie J. Oppenheim

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Out Of Sight, Out Of Mind: Analyzing Inhumane Practices In Mississippi’S Correctional Institutions Due To Overcrowding, Understaffing, And Diminished Funding, Ariel A. Williams

Honors Theses

The purpose of this research is to examine the political, social, and economic factors which have led to inhumane conditions in Mississippi’s correctional facilities. Several methods were employed, including a comparison of the historical and current methods of funding, staffing, and rehabilitating prisoners based on literature reviews. State-sponsored reports from various departments and the legislature were analyzed to provide insight into budgetary restrictions and political will to allocate funds. Statistical surveys and data were reviewed to determine how overcrowding and understaffing negatively affect administrative capacity and prisoners’ mental and physical well-being. Ultimately, it may be concluded that Mississippi has high …

The Pandemic, Climate Change And Farm Subsidies, Allen H. Olson, Edward J. Peterson

Journal of Food Law & Policy

Many people believe that once the COVID-19 pandemic has passed, life will return to the way it was. This belief is both unrealistic and dangerous. It is unrealistic because the virus will be around for years if not indefinitely. The timeframe for the worst of the pandemic will depend on our ability to administer effective vaccines worldwide and the public’s willingness to accept continued social distancing in the meantime. The damage done to public health, the economy and individuals is already substantial and will get worse. Recovery will be slow and incomplete. The belief that life will return to the …

Farmer Cooperatives "Take Cover": The Capper-Volstead Exemption Is Under Siege, Donald M. Barnes, Jay L. Levine

Arkansas Law Review

"When tillage begins, other arts follow. The farmers, therefore, are the founders of human civilization." There can be little dispute that food production is of vital interest to any nation’s security and economy. For this reason, the United States Congress, like many other legislatures around the world, has accorded special treatment to the agricultural industry, and particularly to farmers. One example of this special treatment is the Capper-Volstead Act, which provides farmers with immunity from antitrust liability for joint conduct undertaken by and through an “association” of producers.

The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards

Journal of the National Association of Administrative Law Judiciary

The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …

The Spirit Is Willing: A Proposal For American Single Malt Whiskey, Raymond Cleaveland

Seattle University Law Review

Over the past twenty-five years, small, independent American distilleries have carved out a new niche in the United States liquor market: craft single malt whiskey. Inspired by the success of single malt Scotch and other single malts, American craft distillers are now fighting for their own shelf behind the bar and in the liquor store aisle. In 2018, a cadre of these distillers petitioned the U.S. Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to formally recognize a new category of whiskey in the Code of Federal Regulations: American Single Malt Whiskey. For purposes of consumer protection, the Treasury …

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay Wexler

Seattle University Law Review

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism—by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years—has once again arisen with a new target: cannabis-infused …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …