Food and Drug Law Commons^™

The Employees’ Dilemma: Balancing Internal Reporting, Whistleblowing, And Insider Trading Risks, Geeyoung Min

Seattle University Law Review

The Essay examines how recent developments in insider trading regulations and whistleblower reward programs can lead to unintended and counterproductive results of discouraging employees from using internal reporting channels within corporate compliance programs. While the presence of a robust and well-functioning corporate compliance program is a critical factor both in mitigating the level of public enforcement actions against companies and in protecting corporate managers from liability in private litigation, these programs often provide little incentive for employees to report potential misconduct internally.

Corporate compliance programs are designed to promote the upward information flow within the company, which is essential for …

How The Antidiscrimination Law Of Commercial Transactions Really Works, Helen Norton

Seattle University Law Review

A variety of businesses now cite 303 Creative when seeking First Amendment protection for their refusal to serve certain customers based on those customers’ protected class status. How this litigation will play out remains to be seen. But future courts need not, and should not, repeat the 303 Creative Court’s misunderstanding of how the antidiscrimination law of commercial transactions actually works.

Part I of this Essay explains the Court’s longstanding understanding of the antidiscrimination law of commercial transactions, and then describes the Court’s failure to engage with this precedent in 303 Creative. Part II then identifies the 303 Creative decision’s …

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

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 …

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. …

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 …

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 …

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 …

Crypto & The Climate: Will Local & National Environmental Regulation Save Or Stifle The Cryptocurrency Boom?

Fordham Environmental Law Review

As cryptocurrencies continue to gain traction among mainstream investors and consumers, regulators and lobbyists are increasingly taking note of the potential environmental impacts of the industry. At its core, the process of mining new currency for virtual wallets is energy intensive, which can place strains on electrical grids and accelerate the impacts of climate change. However, these effects are felt very differently depending on what source of electricity the mining operation utilizes and the methodology behind the specific currency. These variable factors are on the minds of legislators and regulators as public pressure to better understand and regulate the industry …

A Shifting Focus: How Algal Turf Scrubbers (Ats) In Natural Waterways Can Prevent Toxic Blooms And Could Save The Algae Energy Industry

Fordham Environmental Law Review

Biofuels have generated global interest among oil companies and governments. In particular, algal biofuels are slated to be more promising than traditional biofuel feedstocks, like corn and sugarcane, which are simultaneously cultivated as food products. However, the drawbacks of harvesting algae on a large industrial scale has led to intense criticism. Most critics focus on issues of sustainability, scalability of production, and the legal and ethical concerns of genetically modified crops. New research in cyanobacteria, however, illustrates algae’s potential to produce clean electricity in addition to oil, ethanol, and gasoline. Moreover, using Algal Turf Scrubbers (“ATS”) in natural waterways offers …

Why We Need A Constitutional Right To Healthy Environment In Canada

Fordham Environmental Law Review

The increasing demand for constitutional recognition of the right to a healthy environment (‘RTHE’) has been a matter of public concern and debate in many countries, including Canada.2 This paper asks, will a constitutional RTHE within the Canadian Constitution add any value when statutes already exist to protect the environment (and thereby health)? The present environmental statutes work towards protecting the environment, and by protecting the environment, public health can be protected.3 Together, both of them form a ‘healthy environment’, ie., an environment that fosters a healthy life.4 This paper will argue that there is additional value in recognizing a …

Bridging The False Certification Gap: Why “Resulting From” In The 2010 Aks Amendment Requires But-For Causation, Alexandra Wildman

Fordham Law Review

Before 2010, violators of the Anti-Kickback Statute (AKS) could avoid False Claims Act (FCA) liability if claims for items or services borne of their kickback scheme were submitted to federal healthcare programs by a third party. In 2010, as part of the Affordable Care Act (ACA), Congress attempted to close this loophole in the FCA by amending the AKS. Under the amendment’s terms, claims submitted to federal healthcare programs for items or services “resulting from” an AKS scheme are false for the purposes of establishing FCA liability, regardless of who submitted the claims.

Although the amendment widened the FCA liability …

Regulatory Takings In Climate Change: Geo- Engineering One’S Way Around The Fifth Amendment, Noah Chase

Fordham Environmental Law Review

Picture yourself as the owner of a small business located in the downtown area of a large city; your business consists of a shop and an adjoining parking lot. A new regulation has just been passed which requires any owner of property within the city limits to paint all roofs and parking areas with a new reflective coating, in order to reduce the heat which is absorbed by such structures. The idea of closing your business down for this time, along with other connected issues, scares you, and you begin to wonder if your local government truly has your best …

Arizona V. Navajo Nation And Systemic Failures In The Tribal Water Allocation Scheme, Jennifer Horkovich

Fordham Environmental Law Review

When the United States Supreme Court’s decision in Arizona v. Navajo Nation was published in June 2023, Indian Country was hardly surprised with the Court’s ruling. There, the Court found that the United States had no affirmative duty to affirmatively protect the Navajo Nation’s water rights under the 1868 Treaty.1 The Court was clear: the treaty is insufficient for the Navajo’s current water needs, but the judiciary is unable to step in to find relief.2 This decision is another in a long series of cases on water allocation and the federal reserved water right, where tribes have been unable to …

Environmental Protection, Sustainability And The Prevention Of Satellite Collisions In Outer Space, Yun Zhao

Fordham Environmental Law Review

With space commercialization and privatization continuing apace, more space objects are expected to be launched and put into operation in the future, adding to the already large number of defunct satellites and space debris present in outer space. Hence, serious study should be devoted to possible mechanisms for dealing with potential collisions in outer space for the purpose of realizing environmental protection and space sustainability. In view of the inadequacy of the existing legal regime, this article explores possible such mechanisms (including a preventive mechanism, avoidance mechanism and compensation mechanism) from the perspective of interdependence theory and puts forward a …

Symposium Remarks: Public Litigation Values Versus The Endless Quest For Global Peace, Elizabeth Chamblee Burch

West Virginia Law Review

No abstract provided.

Henderson And The Objective Observer Standard: The Future Of Race-Conscious Standards Post-Students For Fair Admissions, Gabriela Dionisio

Seattle University Law Review

On June 29, 2023, the Supreme Court of the United States decided Students for Fair Admissions v. President & Fellows of Harvard College, which struck down race-conscious admissions policies. Within just a year after its ruling, Students for Fair Admissions has already had a sweeping impact, reaching beyond higher education. Although the Supreme Court did not indicate whether Students for Fair Admissions applies to sectors beyond higher education, law firms, and other employers have already modified their diversity policies and initiatives, erasing race and company diversity considerations. Given those dramatic changes, there is growing fear that Students for Fair Admissions …

Same Crime, Different Time: Sentencing Disparities In The Deep South & A Path Forward Under The Fourteenth Amendment, Hailey M. Donovan

Seattle University Law Review

The United States has the highest incarceration rate of any country in the world. The American obsession with crime and punishment can be tracked over the last half-century, as the nation’s incarceration rate has risen astronomically. Since 1970, the number of incarcerated people in the United States has increased more than sevenfold to over 2.3 million, outpacing both crime and population growth considerably. While the rise itself is undoubtedly bleak, a more troubling truth lies just below the surface. Not all states contribute equally to American mass incarceration. Rather, states have vastly different incarceration rates. Unlike at the federal level, …

Offshore Wind: A Comparative Of The United States And Norway

Fordham Environmental Law Review

No abstract provided.

Assessing The Human Right To Water And Sanitation In International Law And The Conflict In The Nile Basin

Fordham Environmental Law Review

Ethiopia’s construction and operation of the Grand Ethiopian

Renaissance Dam (GERD) on the Blue Nile has intensified the long-

standing water conflict involving Ethiopia, Egypt, and Sudan, and

highlights the urgent need for a new legal framework for the Nile

Basin’s governance. This article traces the history of the international

human right to water and sanitation and previous attempts to govern

water use in the Nile Basin. We argue that outdated colonial-era

treaties, which Egypt and Sudan insist on using as a baseline for

negotiations, are a significant obstacle to resolving the Nile conflict

and managing the region’s water resources …

Debts And Desertion: Bankruptcy Law And The Orphan Well Crisis

Fordham Environmental Law Review

The issue of orphan wells—unplugged and unproductive oil and

gas wells with no responsible operator—poses a significant

environmental and public health threat in the United States. The scale

of this crisis is alarming: there are over 120,000 documented orphan

wells and potentially millions more undocumented. These wells are

often significant sources of methane emissions and other toxins that

exacerbate climate change and endanger the health of surrounding

communities. This paper examines the orphan well crisis, exploring

how wells become orphaned and the environmental and health

impacts associated with them. Furthermore, it delves into how the

situation is likely to worsen …

Public Primacy In Corporate Law, Dorothy S. Lund

Seattle University Law Review

This Article explores the malleability of agency theory by showing that it could be used to justify a “public primacy” standard for corporate law that would direct fiduciaries to promote the value of the corporation for the benefit of the public. Employing agency theory to describe the relationship between corporate management and the broader public sheds light on aspects of firm behavior, as well as the nature of state contracting with corporations. It also provides a lodestar for a possible future evolution of corporate law and governance: minimize the agency costs created by the divergence of interests between management and …

Robo-Voting: Does Delegated Proxy Voting Pose A Challenge For Shareholder Democracy?, John Matsusaka, Chong Shu

Seattle University Law Review

Robo-voting is the practice by an investment fund of mechanically voting in corporate elections according to the advice of its proxy advisor— in effect fully delegating its voting decision to its advisor. We examined over 65 million votes cast during the period 2008–2021 by 14,582 mutual funds to describe and quantify the prevalence of robo-voting. Overall, 33% of mutual funds robo-voted in 2021: 22% with ISS, 4% with Glass Lewis, and six percent with the recommendations of the issuer’s management. The fraction of funds that robo-voted increased until around 2013 and then stabilized at the current level. Despite the sizable …

The Limits Of Corporate Governance, Cathy Hwang, Emily Winston

Seattle University Law Review

What is the purpose of the corporation? For decades, the answer was clear: to put shareholders’ interests first. In many cases, this theory of shareholder primacy also became synonymous with the imperative to maximize shareholder wealth. In the world where shareholder primacy was a north star, courts, scholars, and policymakers had relatively little to fight about: most debates were minor skirmishes about exactly how to maximize shareholder wealth.

Part I of this Essay discusses the shortcomings of shareholder primacy and stakeholder governance, arguing that neither of these modes of governance provides an adequate framework for incentivizing corporations to do good. …

The Pioneers, Waves, And Random Walks Of Securities Law In The Supreme Court, Elizabeth Pollman

Seattle University Law Review

After the pioneers, waves, and random walks that have animated the history of securities laws in the U.S. Supreme Court, we might now be on the precipice of a new chapter. Pritchard and Thompson’s superb book, A History of Securities Law in the Supreme Court, illuminates with rich archival detail how the Court’s view of the securities laws and the SEC have changed over time and how individuals have influenced this history. The book provides an invaluable resource for understanding nearly a century’s worth of Supreme Court jurisprudence in the area of securities law and much needed context for …