Law Commons^™

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

Measuring State Compliance With The Right To Education Using Indicators: A Case Study Of Colombia’S Obligations Under The Icescr, Sital Kalantry, Jocelyn Getgen, Steven A. Koh

Sital Kalantry

The right to education is often referred to as a “multiplier right” because its enjoyment enhances other human rights. It is enumerated in several international instruments, but it is codified in greatest detail in the International Covenant on Economic, Social and Cultural Rights (ICESCR). Despite its importance, the right to education has received limited attention from scholars, practitioners, and international and regional human rights bodies as compared to other economic, social and cultural rights (ECSRs). In this Article, we propose a methodology that utilizes indicators to measure treaty compliance with the right to education. Indicators are essential to measuring compliance …

For Goodness’ Sake: A Two-Part Proposal For Remedying The U.S. Charity/Justice Imbalance, Fran Quigley

Fran Quigley

The U.S. approach to addressing economic and social needs strongly favors individual and corporate charity over the establishment and enforcement of economic and social rights. This charity/justice imbalance has a severely negative impact on the nation’s poor, who despite the overall U.S. wealth struggle with inadequate access to healthcare, housing, and nutrition. This article suggests a two-part approach for remedying the charity/justice imbalance in the U.S.: First, the U.S. should eliminate the charitable tax deduction, a policy creation that does not effectively address economic and social needs, forces an inequitable poverty relief and tax burden on the middle class, and …

Workshop Democracy: Making Policy In Cote D'Ivoire, Max Levin

Max Levin

Development experts would benefit from a better understanding of how policy is made in developing countries. In this article, I describe how health policy is made in Cote d’Ivoire, from the perspective of a Westerner embedded in the Ministry of Health for 10 months. I provide a narrative of how one health system reform—performance-based financing—moved from policy idea to enacted reform. I describe the origins of the reform in Cote d’Ivoire, how the government came to support the reform, and then the mechanics of how the reform was enacted. I then present observations on how policymaking in Cote d’Ivoire differs …

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

The Presentment Clause Meets The Suspension Power: The Affordable Care Act’S Long And Winding Road To Implementation, Mitchell Widener

Mitchell Widener

The presentment clause MEETs the Suspension Power: The Affordable Care Act’s Long and Winding Road to Implementation

Mitchell J. Widener

Abstract

To enact a law, the Presentment Clause of the Constitution mandates that both Houses of Congress present a bill to the President who either signs it into law or vetoes it. The Founders included this provision to prevent presidents from emulating King James II, who would routinely suspend Parliament’s laws to favor political constituents. Additionally, the Presentment Clause served to enhance the separation-of-powers principle implied in the Constitution.

Within the past year, President Obama has suspended multiple portions of …

Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman

Stephen D Sugarman

No abstract provided.

Taxation Without Limitation: The Prohibited Pretext Doctrine V. The Sebelius Theory, Brett W. Hastings

Brett W Hastings

The Article posits that the Supreme Court erred in its ruling regarding the Affordable Care Act by overlooking a well established constitutional principle, dubbed the Prohibited Pretext Doctrine. This doctrine, which prohibits the exercise of a prohibited power through the pretextual use of a power granted, faded from memory due to the post Lochner era expansion of the Commerce Clause. Nevertheless, the doctrine remains valid law. In overlooking the Prohibited Pretext Doctrine, the Supreme Court established a new and contradictory doctrine, dubbed the Sebelius Theory. The Sebelius Theory turns the Prohibited Pretext Doctrine on its head by explicitly allowing the …

Medical Paternalism And The Rule Of Law: A Reply To Dr. Relman, Charles Baron

Charles H. Baron

In this Article, Professor Baron challenges the position taken recently by Dr. Arnold Relman in this journal that the 1977 Saikewicz decision of the Supreme Judicial Court of Massachusetts was incorrect in calling for routine judicial resolution of decisions whether to provide life-prolonging treatment to terminally ill incompetent patients. First, Professor Baron argues that Dr. Relman's position that doctors should make such decisions is based upon an outmoded, paternalistic view of the doctor-patient relationship. Second, he points out the importance of guaranteeing to such decisions the special qualities of process which characterize decision making by courts and which are not …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

"Health Care For All:" The Gap Between Rhetoric And Reality In The Affordable Care Act, Vinita Andrapalliyal

Vinita Andrapalliyal

The rhetoric of “universal health care” and “health care for all” that pervaded the health care debate which culminated in the Patient Protection and Affordable Care Act (ACA)’s passage. However, the ACA offers reduced to no protections for certain noncitizen groups, specifically: 1) recently-arrived legal permanent residents, 2) nonimmigrants, and 3) the undocumented. This Article explores how the Act fails to ensure “health care for all,” demonstrates the gap between rhetoric and reality by parsing the ACA’s legislative history, and posits reasons for the gap. The ACA’s legislative history suggests that legislators’ biases towards these noncitizen groups, particularly with respect …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Deadly Dicta: Roe’S “Unwanted Motherhood”, Gonzales’S “Women’S Regret” And The Shifting Narrative Of Abortion Jurisprudence, Stacy A. Scaldo

Stacy A Scaldo

For thirty-four years, the narrative of Supreme Court jurisprudence on the issue of abortion was firmly focused on the pregnant woman. From the initial finding that the right to an abortion stemmed from a constitutional right to privacy[1], through the test applied and refined to determine when that right was abridged[2], to the striking of statutes found to over-regulate that right[3], the conversation from the Court’s perspective maintained a singular focus. Pro-life arguments focusing on the fetus as the equal or greater party of interest were systematically pushed aside by the Court.[4] The consequences of an unwanted pregnancy, or as …

South Dakota: Making Dollars And Sense Of Indian Child Removal, Rachael Whitaker

Rachael Whitaker

South Dakota- Making Dollars and Sense of Indian Child Removal By: Rachael Whitaker In 2004, a South Dakota Governor’s Commission report adamantly denied claims that the state’s Department of Social Services (DSS) is “harvesting Indian children as a cash crop” and “runs nothing more than a state sponsored kidnapping program.” National Public Radio (NPR) broke a story in 2011, claiming South Dakota removed Indian children for profit. Since NPR’s report, the state has remained tight-lipped, advocates have threatened litigation, and Congress has asked for answers. South Dakota has a small population and economy, and it receives almost half of its …

Federal Prohibition Of Medical Marijuana In Pain Management: Undue, Unimportant, And Irrational, Michael L. Timm Jr.

Michael L. Timm Jr.

This paper provides a review of the historical right of the people of the United States to seek, and use, alternative medicinal treatment options in the realm of managing both the pain and symptoms associated with a variety of illnesses. The focus then turns to the right involved: a patient’s ability to employ medical marijuana instead of a commonly prescribed narcotic or mass-market non-steroidal anti-inflammatory analgesic (NSAIA) drug to manage pain and increase quality of life under the advice and consent of a treating physician. No one article has argued that there is a fundamental, important, or at least recognizable …

Clear Depictions Promote Clear Decisions: Drafting Abortion Speech-And-Display Statutes That Pass First And Fourteenth Amendment Muster, Ryan J. Pulkrabek

Ryan J Pulkrabek

Several states have passed legislation requiring physicians to take, display, and describe an ultrasound to their patients who are seeking an abortion. These statutes have been challenged under both the Fourteenth and First Amendments because the statutes place burdens on women who seek abortion and compel physician speech. Courts are divided on these questions and state legislatures need guidance as they consider reform. This Article proposes a model "speech-and-display" statute that is both consistent with the Constitution and good public policy. This model statute is designed to protect the mental health of patients and the life of the unborn by …

Functional Government In 3-D, Robert L. Glicksman, Alejandro E. Camacho

Robert L. Glicksman

The creation of new administrative agencies and the realignment of existing governmental authority are commonplace and high-stakes events, as illustrated by the recent creation of the Department of Homeland Security after 9/11 and of new financial regulatory agencies after the global recession of 2009. Scholars and policymakers have not devoted sufficient attention to this subject, failing to clearly identify the different dimensions along which government authority may be structured or to consider the relationships among them. Analysis of these institutional design issues typically also gives short shrift to whether authority should be allocated differently based on agency function. These failures …

Chief Justice Roberts' Individual Mandate: The Lawless Medicine Of Nfib V. Sebelius, Gregory Magarian

Gregory P. Magarian

After the U.S. Supreme Court in National Federation of Independent Business v. Sebelius held nearly all of the Patient Protection and Affordable Care Act constitutional, praise rained down on Chief Justice John Roberts. The Chief Justice’s lead opinion broke with his usual conservative allies on the Court by upholding the Act’s individual mandate under the Taxing Clause. Numerous academic and popular commentators have lauded the Chief Justice for his political courage and institutional pragmatism. In this essay, Professor Magarian challenges the heroic narrative surrounding the Chief Justice’s opinion. The essay contends that the opinion is, in two distinct senses, fundamentally …

Measuring State Compliance With The Right To Education Using Indicators: A Case Study Of Colombia’S Obligations Under The Icescr, Sital Kalantry, Jocelyn Getgen, Steven A. Koh

Cornell Law Faculty Working Papers

The right to education is often referred to as a “multiplier right” because its enjoyment enhances other human rights. It is enumerated in several international instruments, but it is codified in greatest detail in the International Covenant on Economic, Social and Cultural Rights (ICESCR). Despite its importance, the right to education has received limited attention from scholars, practitioners, and international and regional human rights bodies as compared to other economic, social and cultural rights (ECSRs). In this Article, we propose a methodology that utilizes indicators to measure treaty compliance with the right to education. Indicators are essential to measuring compliance …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Biopolitics At The Bedside: Proxy Wars And Feeding Tubes, Joshua E. Perry

ExpressO

In the aftermath of Terri Schiavo’s dramatic final weeks of life, George Annas speculated that proponents of “culture of life” politics might “now view [themselves] as strong enough to generate new laws . . . to require that incompetent patients be kept alive with artificially delivered fluids and nutrition.” Indeed, Professor Annas’ prescience has been demonstrated by the post-Schiavo introduction in two dozen state legislatures of over fifty different bills making it more onerous to remove a patient’s artificial nutrition and hydration (ANH). With minor exception, however, most of the proposed legislation has either stalled or been watered down, prompting …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Standard Errors: How Budget Rules Distort Lawmaking, Timothy M. Westmoreland

ExpressO

The article argues that the Congress’s budget process has invisibly influenced its legislative activities and structurally skewed its policy choices. The budgetary structure and tools as they affect lawmaking are largely unanalyzed. Until they are widely appreciated, they may often be random, inefficient, unrepresentative, and even deceptive. Review, critique, and change are overdue in any case. Inasmuch as the Congress is now, after a period of budget anarchy, debating how to refocus on the budget, this is a particularly good time for such activities.

The article also argues that additional structures are needed to “counter-balance” both the skewing that results …

The Children Of Science: Property, People, Or Something In Between?, Star Q. Lopez

ExpressO

How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of …

“It’S The [Tort System], Stupid:” Consumer Deductibles; How To More Equitably Distribute The Risks Of Medical Malpractice And Adequately Compensate Victims Without Statutory Damage Caps., Bradford Luke Ledbetter

ExpressO

No abstract provided.

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …

The Cocaine Vaccine, Dru Stevenson

ExpressO

The controversial new cocaine vaccine (TA-CD) has the potential to be an extremely effective treatment tool for recovering addicts, but it also presents opportunities for non-therapeutic uses, such as preventing cocaine use in the first place. It is foreseeable that the cocaine vaccine could become a condition of parole or probation, or receiving welfare payments, or for employment in certain occupations. Universal vaccination is also a possibility but less likely for political reasons. This article investigates each of these areas of potential use. Any setting where mandatory drug testing is currently in place could become a venue for the vaccination. …

Atypical Pneumonia And Ambivalent Law And Politics: Sars And The Response To Sars In China, Jacques Delisle

All Faculty Scholarship

No abstract provided.