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Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Voting Matters: Materiality Considerations And The Shareholder Vote, Renee M. Jones

Seattle University Law Review

For the shareholder franchise to have meaning, shareholders must have access to relevant information to inform their voting decisions. The securities laws’ disclosure requirements play an essential role in informing the shareholder vote.

This Essay focuses on the question of the materiality of information in the context of shareholder voting. It addresses the question of whether ESG-related information is material, positioning the materiality inquiry within the context of shareholders’ voting decisions. It explores the definition of materiality with a focus on the “reasonable investor” concept embedded within the definition. The Essay argues that the implicit expectations of many commentators that …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Understanding The Big Three’S Wavering Support Of Environmental And Social Shareholder Proposals, Jeff Schwartz, Jefferson Jensen

Seattle University Law Review

Because of their substantial equity portfolios, BlackRock, Vanguard, and State Street (the Big 3) are central players in corporate governance. It is, therefore, critical to understand how they vote. One puzzle is that their support for shareholder proposals on environmental and social matters appears to waiver. In 2020, for instance, BlackRock supported 11.1% of environmental proposals at S&P 500 firms. In 2021, it seemingly reversed course, supporting 55.2%. It then flipped again, supporting 32.1% in 2022. Such statistics suggest that the Big 3 are constantly changing their views on these topics. This Article seeks to better understand whether this is …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Most-Favored-Nation Drug Pricing—How Courts Could Shape Future Health Regulation, Nicholas Bagley, Craig Garthwaite, Benedic Ippolito

Other Publications

The Trump administration recently issued an Executive Order aimed at delivering most-favored- nation (MFN) drug pricing to the US. The order instructs drug manufacturers to reduce the prices of brand-name drugs to match the lowest price among selected high-income countries. If drug makers do not make significant progress toward this goal, the administration will pursue several strategies to lower prices. Most notably, the Executive Order directs the Secretary of Health and Human Services (HHS) to propose a rule to impose MFN pricing. In all likelihood, the administration will revisit prior efforts to enact MFN pricing through the Center for Medicare …

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

High Hopes, Clouded Realities: Minnesota's Cannabis Legalization And The Hidden Health Risks, Allison Crescimanno

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Green Dividends: A Case Study In Green Dividends And The Conditions For Private Ordering Solutions, Anne M. Tucker

Seattle University Law Review

This Essay introduces a novel private ordering solution to facilitate corporate investments in pro-social and environmental initiatives: Green dividends. Green dividends are an optional increase in shareholder dividends that are returned to the company to be reinvested in environmental initiatives or kept by a shareholder.

Green dividends pose an alternative to the current gridlocked debate that corporations can’t, won’t, shouldn’t, and shouldn’t even try to act in pro-social or environmental ways. Turning the common refrains on their head converts each narrative into an element for a successful private ordering solution: authority, accountability, shareholder buy-in, and government- backed enforcement. With Green …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

The Grass Is Not Always Greener: How The Legalization Of Recreational Cannabis Across The United States Is At Odds With Incarceration And Continued Punishment, Marc Sendra

Washington and Lee Journal of Civil Rights and Social Justice

Whether you call it Mary Jane, skunky funky, green, ganja, reefer, or just plain-old cannabis, this special green plant doused in purple and orange accents has become a popular topic of discussion within the legal community and American culture. Cannabis has been held in “high” regard for its scientific advances in the medical industry, alongside its recreational usage, enjoyed by laughs and giggles, munchies, and plenty of water, leading to a wave of medical and recreational legalization.

Incentives for legalization come at the onset of promising medical research, economic growth motives, and social justice, reflecting upon a comprehensive approach that …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Jbs’S Initial Public Offering: Threats To Environmental And Human Rights, Kayla Thompson

Indiana Journal of Law and Social Equality

This paper centers around the decision to be made regarding JBS, the world’s largest meat company, wanting to list shares on the New York Stock Exchange (NYSE), and the environmental and social impacts that could result from the Security and Exchange Commission’s (SEC) approval. JBS has been at the center of various controversies over the last several years, including sourcing cattle from ranches acquired through illegal deforestation, engaging in greenwashing practices, incorrectly reporting greenhouse gas emissions, and engaging in human rights abuses. Many environmental groups have filed complaints with the SEC concerning JBS’s bid to list on the NYSE. The …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

The Future Of Ai Regulation In Drug Development: A Comparative Analysis, Gabriela Lenarczyk, Timo Minssen, W. Nicholson Price Ii, Arti Rai

Articles

As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper makes three contributions to understanding emerging regulatory approaches. First, we offer a comparative analysis of how these agencies have responded to AI-driven advances, incorporating new US executive orders and the European Union (EU)’s AI Act. Second, we propose a novel analytical framework to understand regulatory divergence: the FDA’s flexible, dialog-driven model contrasts with the EMA’s structured, risk-tiered approach, reflecting broader institutional and political-economic differences. While the former encourages …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

Money Talks: The Disproportionate Influence Of Corporations On U.S. Governance Today, David C. Hayter

Lewis & Clark Law Review

Corruption: “Dishonest or illegal behavior especially by powerful people (such as government officials . . . )”; and “inducement to wrong by improper or unlawful means (such as bribery).”

What does the word “corruption” first bring to mind? For some, maybe a foreign country—where political regimes blatantly use the government as a tool to further personal agendas or gains without due consideration of the citizenry. For others, a fictional movie or TV show depicting politicians and police officers providing protections to mafia members in exchange for cash. No matter what comes to mind, many today think of corruption as manifested …

A Market-Based Approach To Effective Slaughterhouse Line Speed Regulation, Kailey Mcneal

Animal Law Review

The nature of animal agriculture in the United States is heavily industrialized and profit-centered. Industrial animal agriculture maximizes profits and production by employing low-wage workers to do significant loads of labor. Slaughterhouses’ implementation of faster line speeds reflects this tactic. As the industry continues to increase line speeds to boost profits, workers, animals, and the environment continue to face augmented risks to their health and safety. Nonetheless, slaughterhouse line speeds at the federal level remain largely un- and under-regulated. The current federal regulatory scheme is unduly influenced by industry interests, prioritizes profit over safety, and lacks effective enforcement mechanisms. Through …

Remediating Public Health Crises Through Litigation: Lessons From Oklahoma In The Tobacco And Opioid Epidemic Litigations, Caroline Beckworth

Oklahoma Law Review

No abstract provided.

The Interchangeable-Part Structure Of Food And Drug Law, Adam I. Muchmore

FIU Law Review

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. …

The Hunger Games: Food As A Right, Not A Privilege, Camesha F. Little

FIU Law Review

Despite the United Nations' explicit declaration that all humans have a right to food, food insecurity and hunger remain persistent problems in the United States and around the globe. The dystopian landscapes depicted in novels such as The Hunger Games and Parable of the Sower—societies crippled by poverty, oppression, and pervasive starvation—resonate with sobering contemporary realities. This Article examines existing food laws, food rights, and the current protections safeguarding the United States food supply from a humanitarian perspective. Ultimately, this Article argues that the human right to food must expand to encompass a right to healthy or natural food, and …

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

The 340b Drug Pricing Program: Administration, Litigation, And Reform, Ryan P. Knox, Ameet Sarpatwari

Oklahoma Law Review

No abstract provided.

A Spoonful Of Sugar Won’T Help This Medicine Go Down: The Inflation Reduction Act’S Failure To Address Pharmaceutical Evergreening, Megan E.A. Davis

Oklahoma Law Review

No abstract provided.

Transitioning To Regenerative Agriculture: One "Net-Zero" Pledge At A Time, Alexia Brunet Marks

Publications

As climate change intensifies, food sector multinational companies (MNCs), like Nestlé; Mars, Inc.; Unilever; PepsiCo; and Danone, face increasing pressure to reach net-zero by 2050, whereby they would reduce and ultimately eliminate carbon dioxide emissions from their supply chains by 2050. Carbon dioxide emissions are a major business liability, decreasing a firm’s value an average of $212,000 for every one thousand metric tons produced. As companies seek to align their pledges with regional, national, and subnational climate goals, they are legally required to comply with a growing number of disclosure rules for foods entering the United States and the European …

Legal Implications Of Digital Health Apps Informing Food Allergy Labeling For Consumers' Health And Privacy Protection, Kathy Keunghee Kim

Maurer Theses and Dissertations

This dissertation examines food allergy labeling’s use in a digital format. Allergy information is typically found on food packaging and containers to help consumers identify individually concerned allergens. Given the critical role that food allergy labels play in preventing unexpected allergic reactions before selecting or consuming food, it is essential to comprehend the labeling descriptions. However, current regulations and laws regarding allergy labeling often confuse consumers due to the existence of mandatory and voluntary Precautionary Allergy Labeling (PAL) categories and the absence of laws and regulations that require allergy information for restaurant meals. Technology companies have introduced digital health and …

From "Maine Law" To Model Act: Liquor Liability In Maine, William P. Shumaker

Maine Law Review

With the passage of the Maine Liquor Liability Act by the 112th Legislature, the State of Maine has completed a thorough reexamination of its public policy in the area of liability for injuries resulting from the use of alcoholic beverages. For 130 years the state's policy in this area was expressed by the statute commonly known as the dram shop act, the essential provisions of which had remained unchanged for over a century. This statute held sellers and other providers of alcoholic beverages strictly liable to any third party injured as a result of the intoxication of the recipient of …