Law Commons^™

The Wild, Wild West Of Laboratory Developed Tests, John Gilmore

Washington and Lee Law Review Online

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …

Constitutional Resilience, Shannon M. Roesler

Washington and Lee Law Review

Since the New Deal era, our system of constitutional governance has relied on expansive federal authority to regulate economic and social problems of national scale. Throughout the twentieth century, Congress passed ambitious federal statutes designed to address these problems. In doing so, it often enlisted states as regulatory partners—creating a system of shared governance that underpins major environmental statutes, such as the Clean Water Act and the Clean Air Act. These governance structures remain important today as we seek to adapt our laws and institutions to the serious disruptions of climate change. But recent Supreme Court decisions challenge this long-established …

An Administrative Solution To The Student Loan Debt Crisis, Justin C. Van Orsdol

Washington and Lee Law Review Online

To say that the student loan debt crisis is out of control is a massive understatement. Although solutions such as Public Service Loan Forgiveness and the recent temporary payment/interest rate freeze have provided some relief for borrowers, more can be done. Of course, as with any large outlay of taxpayer dollars, opposition is sure to be heated. Given the current political climate, the likelihood of any legislative fixes seems unlikely.

But what if there was an administrative solution that could do more to address this crisis without the cost of the legislative process? This essay proposes such a solution. It …

What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge

Washington and Lee Law Review

Over the past ten years, administrative law scholarship has increasingly focused on interactions between multiple agencies. As part of this trend, most scholars have called for policymakers to combine multiple agencies, rather than rely on a single agency, to solve policy problems. The literature in this area espouses the benefits of shared regulatory space. But very little of this scholarship addresses when shared jurisdiction is problematic. This is particularly concerning when an agency opts into or cedes oversight authority to another agency at will, with little regard for whether the second agency is an appropriate regulator. The case of cell-cultured …

Temporary Securities Regulation, Anita K. Krug

Washington and Lee Law Review

In times of crisis, including during the 2020–2021 global pandemic, the U.S. Securities and Exchange Commission (SEC) has engaged in a type of securities regulation that few scholars have acknowledged, let alone evaluated. Specifically, during recent market crises, the SEC adopted rules that are temporary, designed to help the securities markets and their participants— both public companies and public investment funds, such as mutual funds and ETFs—weather the crisis at hand but go no further. Once that goal has been accomplished, these rules usually expire, replaced by the permanent rules that they temporarily supplanted. Although the temporary-rulemaking endeavor is laudable—and …

Leaving Judicial Review With The Judiciary: The Misplaced Role Of Agency Deference In Tunney Act Public Interest Review, Alexandra P. Clark

Washington and Lee Law Review

This Note explores the Tunney Act’s mechanism for judicial review of consent decrees negotiated by the U.S. Department of Justice and merging parties to remedy alleged antitrust issues. The Tunney Act requires that the reviewing court only approve a consent decree if it is “in the public interest.” This Note argues, however, that courts have improperly circumscribed their review by affording too much deference to the Department of Justice when reviewing these consent decrees. This deference subverts Congress’s intent in imposing judicial review and allows the government and merging parties the opportunity to skirt meaningful judicial review. As such, this …

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

“Waiving” Goodbye To Medicaid As We Know It: Modern State Attempts To Transform Medicaid Programs Through Section 1115 Waivers, Chandler Gray

Washington and Lee Law Review Online

This Note explores recent state efforts to reshape their respective Medicaid programs through Section 1115 waivers. Specifically, this Note looks at states that wish to convert their Medicaid program to a block grant through Section 1115 waivers. Examining the lawfulness of these waivers requires analyzing the language and application of both the Medicaid Act and the Administrative Procedure Act. This Note argues that any use of Section 1115 waivers to implement a block grant program would be a violation of the Medicaid Act and thus unlawful. Further, federal approval of such programs would be deemed arbitrary and capricious. To justify …

Weapons Of Mass Distortion: Applying The Principles Of The Fcc’S News Distortion Doctrine To Undisclosed Financial Conflicts Of Interest In Corporate News Media’S Military Coverage, Charles L. Bonani

Washington and Lee Journal of Civil Rights and Social Justice

This Note offers a new conception of news distortion in mass media. It explores the intentions behind the FCC’s News Distortion Doctrine and analyzes its primarily dormant status throughout its existence. This Note then examines televised media coverage of U.S. military actions and identifies undisclosed financial conflicts of interests throughout this coverage. In examining these undisclosed conflicts and the reasons behind them, this Note explains why they constitute news distortion under the FCC’s definition, and why the principles behind the Doctrine are implicated. This Note then proposes the FCC promulgate a disclosure rule to remedy the undisclosed financial conflicts of …

Disguised Patent Policymaking, Saurabh Vishnubhakat

Washington and Lee Law Review

Patent Office power has grown immensely in this decade, and the agency is wielding its power in predictably troubling ways. Like other agencies, it injects politics into its decisions while relying on technocratic justifications. It also reads grants of authority expansively to aggrandize its power, especially to the detriment of judicial checks on agency action. However, this story of Patent Office ascendancy differs from that of other agencies in two important respects. One is that the U.S. patent system still remains primarily a means for allocating property rights, not a comprehensive regime of industrial regulation. Thus, the Patent Office cannot …

Climate Change, Sustainability, And The Failure Of Modern Property Theory, Jill M. Fraley

Scholarly Articles

Property rights are, I argue, the single largest legal limitation on our ability to respond effectively to the climate change crisis. This is because our understanding of the scope of property rights shapes and limits legal concepts such as regulatory takings, land use law, common law tort and property claims, and statutory environmental regulation. Property sets our cultural norms about how much the government can or should control the uses of land. The goals of this Article are to (1) historically demonstrate the failures of sociallyoriented property theory as they are represented in the analytical framework of doctrines such as …

Tax Attorneys As Defenders Of Taxpayer Rights, Michelle Lyon Drumbl

Scholarly Articles

What is the modern role of a tax practitioner, in particular a tax attorney, in the United States? In an era in which the Internal Revenue Service (IRS) is underfunded, understaffed, and struggles to address its mission, tax attorneys play an important role as advocates for taxpayer rights.

Tax attorneys act as advocates who represent ordinary individual taxpayers in controversies with the IRS. These controversies include post-filing disputes, such as audits, as well as issues arising with the collection of assessed taxes. Many of these cases are resolved at the administrative level; those that cannot be resolved are litigated, most …

For Him Who Shall Have Borne The Battle: How The Presumption Of Competence Undermines Veterans’ Disability Law, Chase Cobb

Washington and Lee Journal of Civil Rights and Social Justice

When the Veterans Administration denies a veteran’s claim for disability benefits it often does so based on the opinion of an expert medical examiner—usually a doctor or a nurse. But under a recent federal rule, the VA carries no burden of laying a foundation for the expert medical examiner’s opinion—no burden of establishing the quality of the expert’s education or the depth of her experience; no burden of establishing the scope of the expert’s training or the soundness of her reasoning. Instead, the VA may simply presume the qualifications of its own expert examiner and throw the burden on the …

This Land Is Your Land, This Land Is Mined Land: Expanding Governmental Ownership Liability Under Cercla, Kiersten E. Holms

Washington and Lee Law Review

Part II of this Note begins by providing a brief overview of the background and goals of CERCLA. Part II also provides an examination of the issue of ownership liability under CERCLA and recounts the federal courts’ difficulty in applying ownership liability. Part II then describes how the federal government’s “bare legal title” argument arose out of the confusion surrounding ownership liability in CERCLA litigation. Part III moves on to examine the recent trend in CERCLA litigation rejecting the federal government’s bare legal title argument, thus holding the federal government liable as an owner based on its possession of legal …

Rehabilitating The Nuisance Injunction To Protect The Environment, Doug Rendleman

Washington and Lee Law Review

The Trump Administration has reversed the federal government’s role of protecting the environment. The reversal focuses attention on states’ environmental capacity. This Article advocates more vigorous state environmental tort remedies for nuisance and trespass. An injunction is the superior remedy in most successful environmental litigation because it orders correction and improvement. Two anachronistic barriers to an environmental injunction are the New York Court of Appeals’ decision, Boomer v. Atlantic Cement, and Calabresi and Melamed’s early and iconic law-and-economics article, One View of the Cathedral. This Article examines and criticizes both because, by subordinating the injunction to money damages, they undervalue …

Justice Kavanaugh, Lorenzo V. Sec, And The Post-Kennedy Supreme Court, Matthew C. Turk, Karen E. Woody

Scholarly Articles

This Article analyzes a recent Supreme Court case, Lorenzo v. Securities and Exchange Commission, and explains why it provides a valuable window into the Court's future now that Justice Kennedy has retired and his seat filled by Justice Brett Kavanaugh. Lorenzo is an important case that raises fundamental interpretative questions about the reach of federal securities statutes. But most significant is its unique procedural posture: when the Supreme Court issues its decision on Lorenzo in 2019, Justice Kavanaugh will be recused while the other eight Justices rule on a lower court opinion from the D.C. Circuit in which he wrote …

Expedited Removal And Due Process: “A Testing Crucible Of Basic Principle” In The Time Of Trump, Daniel Kanstroom

Washington and Lee Law Review

No abstract provided.

Sanctuary Networks And Integrative Enforcement, Ming Hsu Chen

Washington and Lee Law Review

My intended focus is on the widespread response—in cities, churches, campuses, and corporations that together comprise “sanctuary networks”1—to the Trump Administration’s Executive Order 13768 Enhancing Public Safety in the Interior of the United States2 as an instance of the changing relationship between federal, local, and private organizations in the regulation of immigration. After briefly covering the legal background of the Trump Interior E.O., the focus of the Article shifts to the institutional dynamics arising in communities. These institutional dynamics exemplify the beginnings of a reimagined immigration enforcement policy with a more integrative flavor.

Judicial Review Of Disproportionate (Or Retaliatory) Deportation, Jason A. Cade

Washington and Lee Law Review

No abstract provided.

National Security, Immigration And The Muslim Bans, Shoba Sivaprasad Wadhia

Washington and Lee Law Review

No abstract provided.

Administrative Chaos: Responding To Child Refugees—U.S. Immigration Process In Crisis, Lenni B. Benson

Washington and Lee Law Review

No abstract provided.

287(G) Agreements In The Trump Era, Huyen Pham

Washington and Lee Law Review

No abstract provided.

Deconstructing “Sanctuary Cities”: The Legality Of Federal Grant Conditions That Require State And Local Cooperation On Immigration Enforcement, Peter Margulies

Washington and Lee Law Review

No abstract provided.

Clipping The Wings Of Industry: Uncertainty In Interpretation And Enforcement Of The Migratory Bird Treaty Act, Martha G. VáZquez

Washington and Lee Law Review Online

No abstract provided.

Information And The Regulatory Landscape: A Growing Need To Reconsider Existing Legal Frameworks, Anjanette H. Raymond

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel J. Suddarth

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Battle Of The Backlog: How Congressional Inaction Threatens The Integrity Of Medicare, Joshua M. Kaplan

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Quacks Or Bootleggers: Who’S Really Regulating Hedge Funds?, Jeremy Kidd

Washington and Lee Law Review

Influential scholars of corporate law have questioned previous federal interventions into corporate governance, calling it quackery. Invoking images of medical malpractice, these critiques have argued persuasively that Congress, in responding to crises, makes policy that disrupts efficient private rules and established state laws. This Article applies the Bootleggers and Baptists theory to show that Dodd–Frank’s hedge fund rules are more than just negligent or reckless, but designed to benefit special interests that compete with the hedge fund model. Those rules offer no solutions to any real or perceived risks arising from hedge fund investing, but might offer an advantage to …

An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey

Washington and Lee Journal of Civil Rights and Social Justice

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a …

Leidos And The Roberts Court's Improvident Securities Law Docket, Matthew C. Turk, Karen E. Woody

Scholarly Articles

For its October 2017 term, the U.S. Supreme Court took up a noteworthy securities law case, Leidos, Inc. v. Indiana Public Retirement System. The legal question presented in Leidos was whether a failure to comply with a regulation issued by the Securities and Exchange Commission (SEC), Item 303 of Regulation S-K (Item 303), can be grounds for a securities fraud claim pursuant to Rule 10b-5 and the related Section 10(b) of the 1934 Securities Exchange Act. Leidos teed up a significant set of issues because Item 303 concerns one of the more controversial corporate disclosures mandated by the SEC—an …