Food and Drug Law Commons^™

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

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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+ …

The Helicopter State: Misuse Of Parens Patriae Unconstitutionally Precludes Individual And Class Claims, Gabrielle J. Hanna

Washington Law Review

The doctrine of parens patriae allows state attorneys general to represent state citizens in aggregate litigation suits that are, in many ways, similar to class actions and mass-tort actions. Its origins, however, reflect a more modest scope. Parens patriae began as a doctrine allowing the British king to protect those without the ability to protect themselves, including wards and mentally disabled individuals. The rapid expansion of parens patriae standing in the United States may be partly to blame for the relative absence of limiting requirements or even well-developed case law governing parens patriae suits. On the one hand, class actions …

The Rise Of Concentrated Animal Feeding Operations, Their Effects, And How We Can Stop Their Growth, Andrea Prisco

Dickinson Law Review (2017-Present)

Dramatic changes in the agricultural industry over the last century have led to the rise of concentrated animal feeding operations– industrial facilities that raise a large number of animals in confined spaces. Animals raised in these facilities suffer from poor quality of life and abuse. For humans, these facilities have had adverse effects on the environment and public health, but they are also associated with high productivity and low food costs. This Comment analyzes the effects of concentrated animal feeding operations on animal well-being, the environment, and public health. This Comment also analyzes current federal legislation that helps combat the …

It’S About Lyme: Why Congress Must Enact Medical Insurance Coverage Laws For Lyme Disease Patients Now, Jennifer Barrett

Seattle University Law Review Online

The Centers for Disease Control and Prevention (CDC) estimates approximately 476,000 people are diagnosed with Lyme disease in the United States each year. While many will recover with a short course of antibiotics, up to 35% will suffer from persistent symptoms after initial treatment. Despite scientific evidence showing the infection can persist long after initial treatment, most insurance companies restrict access to treatment beyond twenty-eight days, leaving patients to bear much of the financial burden. To limit crippling out-of-pocket expenses, Congress must enact legislation mandating coverage for the treatment of clinically diagnosed Lyme disease and co-infections based on the International …

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Seattle University Law Review

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The Status Of California's Pay-For-Delay Legislation And Litigation, Jordan Paradise

Faculty Publications & Other Works

Pay-for-delay settlements arise when the brand drug company compensates the generic in some form to delay entry to market, thereby effectively eliminating the 180-day exclusivity on the market the generic is entitled to under law. At the federal level, the Supreme Court has established factors to determine whether such agreements violate antitrust law, policymakers have introduced legislation to curb the practice, and the Federal Trade Commission continues to actively police such deals. At the state level, California Attorney General Xavier Becerra made headlines for securing legal settlements in July 2019 with several pharmaceutical companies accused of participating in pay-for-delay agreements. …

“Over-Stressed” Vines Produce No Wines, Whereas “Under-Stressed” Vines Mass Produce: Consolidation, Anti-Competition, And The Fall Of The Family Winery, Elyse Gottschalk

University of San Francisco Law Review

No abstract provided.

Autumn Is Coming: A Novel Liability Theory That May Kill Pharmaceutical Evergreening, Uri Y. Hacohen

Cardozo Arts & Entertainment Law Journal

Pharmaceutical evergreening-attempts by brand-name manufacturers to leverage patent rights to artificially extend legal protection for drugs-is among the most pressing and unresolved public policy challenges of our time. On July 14, 2021, in Sanofi et al. vs. Unipharm Ltd., the Israeli Supreme Court adopted a novel and internationally unprecedented legal policy to combat the evergreening pandemic. By using its equitable powers, the Israeli court empowered a generic manufacturer, Unipharm, to claim on behalf of the public interest the wrongly obtained monopoly profits that a brand-name manufacturer, Sanofi, obtained by improperly leveraging its improvement patent to impair generic market entry. This …

France's Organisme De Défense Et De Gestion: A Model For Farmer Collective Action Through Standard Development And Brand Management, Christopher J. Bardenhagen, Philip H. Howard, Marie-Odile Noziéres-Petit

Journal of Food Law & Policy

Quality-based food production, often with a regional dimension, can provide farmers with new, value added markets. It can also provide consumers with access to place based high-quality products, and may benefit local economies through increased commerce. French Organismes de Défense et de Gestion (ODGs) illustrate a mode of quality-based agri-food business organization. ODGs focus on the development of production standards, as well as management of the intellectual property related to those standards. This mode, which is commonly used in Europe, has not often been used in the United States, despite its potential for regional food system development. The ODG mode …

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 …

A Storm Is Brewing: How Federal Ambivalence Regarding Below-Cost Pricing Turns A Blind Eye To Monopoly Risk In The Beer Market, Daniel Croxall

Loyola of Los Angeles Law Review

Large beer manufacturers, known colloquially as “Big Beer,” have been steadily losing market share to small, independent craft breweries. Big Beer wants it market share back, and in some cases will go to great lengths to try to defend its dominance—even anticompetitive conduct. Below-cost pricing is one avenue that presents a risk to independent craft breweries. This Article examines how Big Beer can manipulate the beer market in its favor by engaging in predatory pricing. Further, this Article proposes a solution that could be implemented on a nation-wide scale to curtail Big Beer’s anticompetitive activities with respect to pricing.

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.

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 …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

The U.S. Dairy Industry In The 20th And 21st Century, George B. Frisvold

Journal of Food Law & Policy

At the beginning of the 20th Century, the U.S. dairy industry was comprised of millions of small-scale operations producing for their own or for very local consumption. By the end of the 20th Century, the industry was dominated by large-scale producers marketing products via large cooperatives. Improvements in transportation, advances in animal breeding and feeding technologies, and scale economies have allowed the industry to be more competitive on global markets, where there is now active international trade in dairy products. Major government programs to support dairy farm income date back to Depression-era problems facing the industry. Federal programs to support …

Shifting The Burden On Pay-For-Delay Challenges: Analyzing Ab 824’S Effects On Reverse Payment Settlements And Drug Costs, Kevin Wallentine

Loyola of Los Angeles Law Review

Antitrust scholars and agencies have recognized the anticompetitive impact of reverse payment settlements—in which branded and generic drug companies settle patent disputes, typically by delaying the entry of generics into the market. Despite clear competition concerns, these settlements are typically subject to a rule of reason analysis that puts the burden on enforcers and plaintiffs to prove their anticompetitive harms. Recent California legislation—AB 824—shifts the burden to the settling drug companies to prove their arrangement is not anticompetitive. AB 824 presents an opportunity for advocates of lower drug costs but still faces hurdles and shortfalls. This Note examines the efficacy …

Enough Is As Good As A Feast, Noah C. Chauvin

Seattle University Law Review

Ipse Dixit, the podcast on legal scholarship, provides a valuable service to the legal community and particularly to the legal academy. The podcast’s hosts skillfully interview guests about their legal and law-related scholarship, helping those guests communicate their ideas clearly and concisely. In this review essay, I argue that Ipse Dixit has made a major contribution to legal scholarship by demonstrating in its interview episodes that law review articles are neither the only nor the best way of communicating scholarly ideas. This contribution should be considered “scholarship,” because one of the primary goals of scholarship is to communicate new ideas.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

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The Heavy Hand Of Amazon: A Seller Not A Neutral Platform, Edward J. Janger, Aaron D. Twerski

Brooklyn Journal of Corporate, Financial & Commercial Law

Since the adoption of Section 402A of the Second Restatement of Torts, every party in a product’s distribution chain has been potentially liable for injuries caused by product defects. Consumers who buy from reputable sellers are almost always guaranteed to have a solvent defendant if injured by a product defect. Amazon, though responsible for a vast number of retail sales, has sought to avoid liability by claiming that it is not a seller but a neutral platform that merely facilitates third-party sales to consumers. With two significant exceptions, most courts have sided with Amazon and concluded that Amazon is not …

Pharmaceutical "Pay-For-Delay" Reexamined: A Dwindling Practice Or A Persistent Problem?, Laura Karas, Gerard F. Anderson, Robin Feldman

Articles

The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or "pay-for-delay." Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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.

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

St. Mary's Law Journal

Abstract forthcoming

The Future Of Dairy Cooperatives In The Modern Marketplace: Redeveloping The Capper-Volstead Act, Sarah K. Phillips

Dickinson Law Review (2017-Present)

Agriculture plays a fundamental role in the U.S. economy as a multibillion-dollar industry that feeds people all over the world. However, over the past decade, the dairy industry in particular has changed from a reliable sector of the greater agricultural industry into an unsettled, politically-charged, and fractured group. Dairy farmers’ consistently receiving low milk prices has facilitated this divide. Tired of being ignored and underpaid, dairy farmers are demanding change in the current dairy market structure.

Federal Milk Marketing Orders and a variety of statutes regulate the dairy industry, but the 1922 Capper-Volstead Act remains the most notable piece of …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.