Food and Drug Law Commons^™

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 …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Corporate Scenarios: Drawing Lessons From History, Madison Condon

Seattle University Law Review

As corporations are increasingly pressed to reveal information about their exposure to climate-related risks, they are often asked to undertake and disclose the outcome of “scenario analysis.” In this exercise, corporations, including financial institutions, examine how their business would fare under different pathways the future may take. One oft-used scenario, for example, is the International Energy Agency’s “Net-Zero by 2050: A Roadmap for the Energy Sector.” This Essay presents a history of the use of scenarios as a corporate planning tool, particularly in the oil industry, arguing that it is key for understanding our present moment and the role of …

Shareholder Expression In A Time Of Heightened Political Tension, Aaron A. Dhir

Seattle University Law Review

In this article, I provide context for my forthcoming research project on shareholder proposals and racial equity audits. Since the murder of George Floyd in May of 2020, progressive shareholder actors have increasingly used the proposal mechanism to advance diversity, equity, inclusion, and justice-related goals. These proposals have frequently gone beyond requesting the usual corporate fare of diversity trainings, intersectionality workshops, affinity groups, etc. Instead, a more ambitious type of proposal asks corporate America to conduct racial equity audits, defined as “an independent, objective and holistic analysis of a company’s policies, practices, products, services and efforts to combat systemic racism …

Corporate Governance Speech, Sarah C. Haan

Seattle University Law Review

The State has always regulated the intra-firm communications that make corporate governance possible, most commonly by mandating disclosures of information by a corporation to its shareholders. Some such laws are labeled “securities regulation,” but securities regulation is a broad category that extends to speech by actors who are outside the corporate enterprise as well. Also, the conventional securities regulation category does not capture all such laws; other examples, including informationforcing mandates, can be found in state corporate law. This Article uses the term “corporate governance speech” to describe the communications among shareholders, directors, and officers through which corporate governance is …

Dark Accounting Matter, Colleen Honigsberg

Seattle University Law Review

Physicists calculate that approximately 85% of the matter in the universe is composed of “dark matter” that “does not absorb, reflect, or emit electromagnetic radiation and is therefore difficult to detect.” The S&P 500 currently trades at a price-to-book value of 4.2, suggesting that book value accounts for less than 20% of the S&P 500’s market value. The remaining 80% appears nowhere in these firms’ balance sheets—it is invisible to contemporary accounting techniques and constitutes “dark accounting matter.”

Some “dark accounting matter” is composed of factors commonly described as components of “ESG.” Human capital, for example, is an intangible asset …

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 …

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

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.

A History Of Corporate Law Federalism In The Twentieth Century, William W. Bratton

Seattle University Law Review

This Article describes the emergence of corporate law federalism across a long twentieth century. The period begins with New Jersey’s successful initiation of charter competition in 1888 and ends with the enactment of the Sarbanes-Oxley Act in 2002. The federalism in question describes the interrelation of state and federal regulation of corporate internal affairs. This Article takes a positive approach, pursuing no normative bottom line. It makes six observations: (1) the federalism describes a division of subject matter, with internal affairs regulated by the states and securities issuance and trading regulated by the federal government; (2) the federalism is an …

Stakeholder Capitalism’S Greatest Challenge: Reshaping A Public Consensus To Govern A Global Economy, Leo E. Strine Jr., Michael Klain

Seattle University Law Review

The Berle XIV: Developing a 21st Century Corporate Governance Model Conference asks whether there is a viable 21st Century Stakeholder Governance model. In our conference keynote article, we argue that to answer that question yes requires restoring—to use Berle’s term—a “public consensus” throughout the global economy in favor of the balanced model of New Deal capitalism, within which corporations could operate in a way good for all their stakeholders and society, that Berle himself supported.

The world now faces problems caused in large part by the enormous international power of corporations and the institutional investors who dominate their governance. These …

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 …

The Need For Corporate Guardrails In U.S. Industrial Policy, Lenore Palladino

Seattle University Law Review

U.S. politicians are actively “marketcrafting”: the passage of the Bipartisan Infrastructure Law, the CHIPS and Science Act, and the Inflation Reduction Act collectively mark a new moment of robust industrial policy. However, these policies are necessarily layered on top of decades of shareholder primacy in corporate governance, in which corporate and financial leaders have prioritized using corporate profits to increase the wealth of shareholders. The Administration and Congress have an opportunity to use industrial policy to encourage a broader reorientation of U.S. businesses away from extractive shareholder primacy and toward innovation and productivity. This Article examines discrete opportunities within the …

Securities Regulation And Administrative Deference In The Roberts Court, Eric C. Chaffee

Seattle University Law Review

In A History of Securities Law in the Supreme Court, A.C. Pritchard and Robert B. Thompson write, “Securities law offers an illuminating window into the Supreme Court’s administrative law jurisprudence over the last century. The securities cases provide one of the most accessible illustrations of key transitions of American law.” A main reason for this is that the U.S. Securities and Exchange Commission (SEC) is a bellwether among administrative agencies, and as a result, A History of Securities Law in the Supreme Court is a history of administrative law in the Supreme Court of the United States as well.

Delegated Corporate Voting And The Deliberative Franchise, Sarah C. Haan

Seattle University Law Review

Starting in the 1930s with the earliest version of the proxy rules, the Securities and Exchange Commission (SEC) has gradually increased the proportion of “instructed” votes on the shareholder’s proxy card until, for the first time in 2022, it required a fully instructed proxy card. This evolution effectively shifted the exercise of the shareholder’s vote from the shareholders’ meeting to the vote delegation that occurs when the share-holder fills out the proxy card. The point in the electoral process when the binding voting choice is communicated is now the execution of the proxy card (assuming the shareholder completes the card …