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Articles 1 - 30 of 75
Full-Text Articles in Law
Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio
Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio
Washington and Lee Law Review
Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.
Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without …
Constitutional Resilience, Shannon M. Roesler
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 …
What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge
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
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
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
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 …
Disguised Patent Policymaking, Saurabh Vishnubhakat
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 …
This Land Is Your Land, This Land Is Mined Land: Expanding Governmental Ownership Liability Under Cercla, Kiersten E. Holms
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
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 …
Administrative Chaos: Responding To Child Refugees—U.S. Immigration Process In Crisis, Lenni B. Benson
Administrative Chaos: Responding To Child Refugees—U.S. Immigration Process In Crisis, Lenni B. Benson
Washington and Lee Law Review
No abstract provided.
National Security, Immigration And The Muslim Bans, Shoba Sivaprasad Wadhia
National Security, Immigration And The Muslim Bans, Shoba Sivaprasad Wadhia
Washington and Lee Law Review
No abstract provided.
Expedited Removal And Due Process: “A Testing Crucible Of Basic Principle” In The Time Of Trump, Daniel Kanstroom
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.
Deconstructing “Sanctuary Cities”: The Legality Of Federal Grant Conditions That Require State And Local Cooperation On Immigration Enforcement, Peter Margulies
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.
Sanctuary Networks And Integrative Enforcement, Ming Hsu Chen
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.
287(G) Agreements In The Trump Era, Huyen Pham
287(G) Agreements In The Trump Era, Huyen Pham
Washington and Lee Law Review
No abstract provided.
Judicial Review Of Disproportionate (Or Retaliatory) Deportation, Jason A. Cade
Judicial Review Of Disproportionate (Or Retaliatory) Deportation, Jason A. Cade
Washington and Lee Law Review
No abstract provided.
Quacks Or Bootleggers: Who’S Really Regulating Hedge Funds?, Jeremy Kidd
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 …
Collaborative Gatekeepers, Stavros Gadinis, Colby Mangels University Of California - Berkeley
Collaborative Gatekeepers, Stavros Gadinis, Colby Mangels University Of California - Berkeley
Washington and Lee Law Review
In their efforts to hold financial institutions accountable after the 2007 financial crisis, U.S. regulators have repeatedly turned to anti-money-laundering laws. Initially designed to fight drug cartels and terrorists, these laws have recently yielded billion-dollar fines for all types of bank engagement in fraud and have spurred an overhaul of financial institutions’ internal compliance. This increased reliance on anti-money-laundering laws, we argue, is due to distinct features that can better help regulators gain insights into financial fraud. Most other financial laws enlist private firms as gatekeepers and hold them liable if they knowingly or negligently engage in client fraud. Yet, …
Trademark Laundering, Useless Patents, And Other Ip Challenges For The Marijuana Industry, Sam Kamin, Viva R. Moffat University Of Denver College Of Law
Trademark Laundering, Useless Patents, And Other Ip Challenges For The Marijuana Industry, Sam Kamin, Viva R. Moffat University Of Denver College Of Law
Washington and Lee Law Review
No abstract provided.
Regulatory Monopoly And Differential Pricing In The Market For Patents , Neel U. Sukhatme
Regulatory Monopoly And Differential Pricing In The Market For Patents , Neel U. Sukhatme
Washington and Lee Law Review
Patents are limited-term monopolies awarded to inventors to incentivize innovation. But there is another monopoly that has been largely overlooked at the heart of patent law: the monopoly of the U.S. Patent and Trademark Office (PTO) over the granting of patents. This Article addresses this topic by developing the notion of a regulatory monopoly, where a single governmental actor has the power to set prices in a regulatory area. The Article explains how regulatory monopolists like the PTO could enhance social welfare via differential pricing—by charging regulated entities differing fees based on their willingness and ability to pay. In particular, …
Facing Down The Trolls: States Stumble On The Bridge To Patent-Assertion Regulation , David Lee Johnson
Facing Down The Trolls: States Stumble On The Bridge To Patent-Assertion Regulation , David Lee Johnson
Washington and Lee Law Review
No abstract provided.
Dynamic Forest Federalism, Blake Hudson
Dynamic Forest Federalism, Blake Hudson
Washington and Lee Law Review
State and local governments have long maintained regulatory authority to manage natural resources, and most subnational governments have politically exercised that authority to some degree. Policy makers, however, have increasingly recognized that the dynamic attributes of natural resources make them difficult to manage on any one scale of government. As a result, the nation has shifted toward multilevel governance known as “dynamic federalism” for many if not most regulatory subject areas, especially in the context of the natural environment. The nation has done so both legally and politically—the constitutional validity of expanded federal regulatory authority over resources has consistently been …
Confession Of Error By Administrative Agencies, Alexander L. Merritt
Confession Of Error By Administrative Agencies, Alexander L. Merritt
Washington and Lee Law Review
No abstract provided.
Removal To Federal Courts From State Administrative Agencies: Reevaluating The Functional Test, Erica B. Haggard
Removal To Federal Courts From State Administrative Agencies: Reevaluating The Functional Test, Erica B. Haggard
Washington and Lee Law Review
No abstract provided.
Personal Liability As Administrative Law, David Zaring
Personal Liability As Administrative Law, David Zaring
Washington and Lee Law Review
Administrative Law has almost exclusively concerned itself with Lawsuits against agencies as collective entities, under the auspices of the Administrative Procedure Act. In light of the growing number and prominence ofsuits by war on terror plaintiffs against senior government officials, this Article considers the use ofpersonal liability to discipline government officials and assesses it as an alternative to traditional administrative Law. It compares the civil suits to criminal prosecutions of these officials and compares both of them to lessobviously Law related scandal campaigns. Personal sanctions--of which Bivens complaints are a principal example-are worth more attention. These mechanisms, and the constitutional …
Protection From A Well-Founded Fear: Applying The Disfavored Group Analysis In Asylum Cases, Bridget Tainer-Parkins
Protection From A Well-Founded Fear: Applying The Disfavored Group Analysis In Asylum Cases, Bridget Tainer-Parkins
Washington and Lee Law Review
No abstract provided.
Designing Transparency: The 9/11 Commission And Institutional Form, Mark Fenster
Designing Transparency: The 9/11 Commission And Institutional Form, Mark Fenster
Washington and Lee Law Review
Surpassing the low expectations established by previous investigatory commissions and overcoming the political and legal obstacles created by the Bush administration's opposition to its creation, the 9/11 Commission accomplished what appeared to be the impossible: an authoritative investigation, a widely-read final report, and direct influence on significant legislation. This Article argues that the 9/11 Commission represents an important institutional model for encouraging orforcing the Executive Branch to disclose information about an especially significant and controversial past event or future decision. It suggests that Congress or the President consider establishing such commissions when information held by the Executive Branch can help …
Just When I Thought I Was Out, They Pull Me Back In: Executive Power And The Novel Reclassification Authority, Luppe B. Luppen
Just When I Thought I Was Out, They Pull Me Back In: Executive Power And The Novel Reclassification Authority, Luppe B. Luppen
Washington and Lee Law Review
No abstract provided.
Running On Empty: Will Exxon Mobil Cause A Breakdown For Chevron And The Administrative State?, Meredith Abernathy
Running On Empty: Will Exxon Mobil Cause A Breakdown For Chevron And The Administrative State?, Meredith Abernathy
Washington and Lee Law Review
No abstract provided.
Examining Epact 2005: A Prospective Look At The Changing Regulatory Approach Of The Ferc, Heather Curlee
Examining Epact 2005: A Prospective Look At The Changing Regulatory Approach Of The Ferc, Heather Curlee
Washington and Lee Law Review
No abstract provided.