Law Commons^™

Interpretation And Interdependence: How Judges Use The Avoidance Canon In Separation Of Powers Cases, Brian C. Murchison

Brian C. Murchison

None available.

Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Michael J. Malinowski

This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Drug Development--Stuck In A State Of Puberty?: Regulatory Reform Of Human Clinical Research To Raise Responsiveness To The Reality Of Human Variability, Michael J. Malinowski

Michael J. Malinowski

Scathing critiques of the Food and Drug Administration's (“FDA”) performance by the Government Accountability Office and Institutes of Medicine, a plummet in innovative new drug approvals in spite of significant annual investment increases in biopharmaceutical research and development (“R&D”), and market controversies such as the painkiller Vioxx and the diabetes drug Avandia (both associated with significantly escalated risks of heart attacks and strokes) have raised doubts about the sufficiency of FDA *364 regulation. This Article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. …

Treating Physicians As Expert Witnesses In Compensation Systems: The Public Health Connection, Brian C. Murchison

Brian C. Murchison

Not available.

Moments Of Silence In Administrative Law: Notes On Judicial Method In The Deregulation Cases, Brian C. Murchison

Brian C. Murchison

None available

The Concept Of Independence In Public Law, Brian C. Murchison

Brian C. Murchison

None available.

On Ripeness And 'Pragmatism' In Admininstrative Law, Brian C. Murchison

Brian C. Murchison

None available.

Due Process, Black Lung, And The Shaping Of Administrative Justice, Brian C. Murchison

Brian C. Murchison

None available.

Federalism And Fiduciaries: A New Framework For Protecting State Benefit Funds, Richard E. Mendales

Richard E. Mendales

The financial crisis has underlined difficulties faced by states and their subdivisions in paying benefits to their employees. The most spectacular example is Detroit's bankruptcy, but state and local employers across the country face sharp cuts in benefits as their employers fight for solvency. A federal solution such as ERISA is precluded by considerations of federalism and the impracticability of getting major legislation through Congress. This Article proposes an alternative solution: a uniform state code, following other uniform state laws such as the Uniform Commercial Code, that states could adopt to govern both state and local plans. It would finance …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

Overcoming Obstacles To Religious Exercise In K-12 Education, Lewis M. Wasserman

Lewis M. Wasserman

Overcoming Obstacles to Religious Exercise in K-12 Education LEWIS M. WASSERMAN Abstract Judicial decisions rendered during the last half-century have overwhelmingly favored educational agencies over claims by parents for religious accommodations to public education requirements, no matter what constitutional or statutory rights were pressed at the tribunal, or when the conflict arose. These claim failures are especially striking in the wake of the Religious Freedom Restoration Acts (“RFRAs”) passed by Congress in 1993 and, to date, by eighteen state legislatures thereafter, since the RFRAs were intended to (1) insulate religious adherents from injuries inflicted by the United States Supreme Court’s …

Freedmen And Day Laborers: Why Enforcement Matters, Raja Raghunath

Raja Raghunath

As the one hundred and fiftieth anniversary of Emancipation approaches, there are cautionary lessons for modern workers to be found in Reconstruction, the period that followed the abolition of chattel slavery. It was mostly due to vehement opposition that the promise of universal liberty at work was squelched after the Civil War, but the federal government also bears responsibility for not defending the rights it had granted to the freed slaves, or freedmen, when those rights were contested and eventually nullified in the working fields and cities of the South. In this sense, workers’ rights were the original civil rights, …

The Legitimacy Of Crimmigration Law, Juliet P. Stumpf

Juliet P Stumpf

Crimmigration law—the intersection of immigration and criminal law—with its emphasis on immigration enforcement, has been hailed as the lynchpin for successful political compromise on immigration reform. Yet crimmigration law’s unprecedented approach to interior immigration and criminal law enforcement threatens to undermine public belief in the fairness of immigration law. This Article uses pioneering social science research to explore people’s perceptions of the legitimacy of crimmigration law. According to Tom Tyler and other compliance scholars, perceptions about procedural justice—whether people perceive authorities as acting fairly—are often more important than a favorable outcome such as winning the case or avoiding arrest. Legal …

Overcoming Obstacles To Religious Exercise In K-12 Education, Lewis M. Wasserman

Lewis M. Wasserman

Overcoming Obstacles to Religious Exercise in K-12 Education Lewis M. Wasserman Abstract Judicial decisions rendered during the last half-century have overwhelmingly favored educational agencies over claims by parents for religious accommodations to public education requirements, no matter what constitutional or statutory rights were pressed at the tribunal, or when the conflict arose. These claim failures are especially striking in the wake of the Religious Freedom Restoration Acts (“RFRAs”) passed by Congress in 1993 and, to date, by eighteen state legislatures thereafter, since the RFRAs were intended to (1) insulate religious adherents from injuries inflicted by the United States Supreme Court’s …

Too Complex To Perceive?: Drafting Cash Distribution Waterfalls Directly As Code To Reduce Complexity And Legal Risk In Structured Finance, Master Limited Partnership, And Private Equity Transactions, Ralph Carter Mayrell

Ralph Carter Mayrell

The intricate procedural and data-driven decision trees that play a critical role in complex financial contracts like cash distribution waterfalls in structured finance agreement indentures (e.g., collateralized debt obligations (CDOs)), master limited partnership agreements, and private equity fund agreements are inefficiently depicted as written contracts. As Professor Henry Hu explains in Too Complex to Depict?, the difficulty of translation—or depiction—between original mathematical models, plain English prospectuses, legal contracts, and programmed execution means that often the written depictions that form the basis of disclosures do not accurately define the act of execution. To overcome this, the SEC proposed an amendment to …

U.S. Government Counterterrorism Asset Freezes: Regulatory Seizures In A Digital Age Of Terrorism, Adam S. Wallwork

Adam S Wallwork

This Article addresses the question of when, if ever, the Department of the Treasury’s counterterrorism asset freezes against US persons (US citizens, resident aliens, and US-based organizations) violate the Fourth Amendment. It addresses two questions that currently divide the federal courts: (1) whether OFAC blocking orders are seizures subject to the Fourth Amendment and (2) whether the Fourth Amendment’s warrant and probable-cause requirements apply to OFAC counterterrorism blocking orders if these orders are in fact seizures.

My Originalist analysis of OFAC counterterrorism blocking orders draws on evidence of the Framers’ original understanding of “unreasonable . . . seizures,” including the …

Una Propuesta De Formulación De Principios Jurídicos De La Fase De Ejecución De Los Contratos Públicos De Concesión De Servicios Públicos Y Obras Públicas De Infraestructura, Ramon Huapaya Jr.

Ramon Huapaya Jr.

In this article, the author approaches the complex issue of the nature of the concession contract, under the premise of accepting the unitary theory of the public contracts. Is analyzed this type of contract under the promotion system of private investment in Peru, led to public utilities and public infrastructure works legal regime which is used by the Peruvian State to relate to private entities that are responsible for such activities.

Furthermore, the author also emphasizes the various principies that have to prevail in this type of concession contracts.

Judicial Deference And Institutional Character: Homeowners Associations And The Puzzle Of Private Governance, Michael C. Pollack

Michael C. Pollack

Much of the study of judicial review of governing institutions focuses on the institutions of public government at the federal, state, and local levels. But the courts’ relationship with private government is in critical need of similar examination, and of a coherent framework within which to conduct it. This Article uses the lens of homeowners associations—a particularly ubiquitous form of private government—to construct and employ such a framework. Specifically, this Article proceeds from the notion that judicial deference is less appropriate the more unaccountable a governing institution is. It therefore develops a set of tests for institutional accountability and applies …

Snopa And The Ppa: Do You Know What It Means For You? If Snopa (Social Networking Online Protection Act) Or Ppa (Password Protection Act) Do Not Pass, The Snooping Could Cause You Trouble, Angela Goodrum

Angela Goodrum

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Dodd-Frank Regulators, Cost-Benefit Analysis, And Agency Capture, Paul Rose, Christopher J. Walker

Christopher J. Walker

The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank) has raised the stakes for financial regulation by requiring more than twenty federal agencies to promulgate nearly 400 new rules. Scholars, regulated entities, Congress, courts, and the agencies themselves have all recognized — even before Dodd-Frank — the lack of rigorous cost-benefit analysis in the context of financial rulemaking. The D.C. Circuit has struck down several financial regulations because of inadequate cost-benefit analysis, with three more challenges to be decided this summer. Members of Congress have introduced legislation to address this problem, including a call for the President to intervene …

Detention Of Children Under Vietnamese Administrative Law: Is It Criminal?, Cheryl J. Lorens

Cheryl J Lorens

In the Socialist Republic of Vietnam the administrative law system permits executive authorities to detain children who have committed minor violations of the law for up to two years in reform schools. Under Vietnamese law these children have not committed a criminal offence and remain outside the protections of article 14 of the International Covenant on Civil and Political Rights (ICCPR). However, the Human Rights Committee allows for the full application of Article 14 and the right to a fair trial to situations where individuals are charged with offences under laws distinct from the criminal law, but which are nevertheless …

The Role Of Culture In Advocating For Accurate Diagnosis And Rating Of Veterans’ Psychological Disabilities, Hillary A. Wandler

Hillary A Wandler

To decide whether a veteran is compensated for a psychological disability connected to the veteran’s military service, the VA will usually require the veteran to be examined by a doctor, who will report on the veteran’s medical or psychiatric condition(s) and how well the veteran is functioning. The VA will rely heavily on the medical report to determine the severity of the veteran’s psychological disability. Advocates for disabled veterans help their veteran clients navigate this process and receive an amount of compensation that most appropriately compensates the veteran for how much the psychological disability actually impairs his ability to earn …

Will Law Firms Go Public?, Roberta S. Karmel

Roberta S. Karmel

Law in the United States is a big business and big law firms are a global business. Currently, under rules of the American Bar Association (ABA) and most states law, firms are not allowed either to include non-lawyers as partners or accept equity investments from non-lawyers. This Article will argue that (even if law firms retain the form of partnerships) they eventually will accept investments from third parties, and possibly even go public, but this development could lead to a loss of professionalism, as it has with other industries, and could also lead to the end of self-regulation. Among the …

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

Dodd-Frank’S Confict Minerals Rule: The Tin Ear Of Government-Business Regulation, Henry Lowenstein

Henry Lowenstein

This paper examines an unusual provision included in the Dodd-Frank Wall Street Reform and Consumer Protection Act (2010), Section 1502 known as the Conflict Minerals Rule. This provision, having nothing to do with the subject matter of the act itself, attempts to place a chilling effect on the trade of four identified minerals from the Democratic Republic of Congo. The provision and its subsequent rule, surprisingly delegated to the U.S. Securities and Exchange Commission (an agency lacking subject matter expertise in minrals) presents a case and object lession of almost every cost, procedural and legal error that can take place …

Social Protection Afforded To Irregular Migrant Workers: Thoughts On International Norms, The Southern African Development Community, Botswana And South Africa, Bruno Ps Van Eck, Felicia Snyman

Bruno PS Van Eck

The majority of migrant workers target those countries in southern Africa that have stronger economies. Irregular migrants are in a particularly vulnerable position, and this article discusses the protection that this category of persons may expect to experience in the southern African region. The authors recommend that the broad notion of “social protection”, rather than the narrower concept “social security” should be emphasized. International, continental and regional instruments providing protection to irregular migrants are traversed and the constitutional and legislative frameworks in relation to social protection in Botswana and South Africa are compared. The article concludes that there are significant …

Hearing On Regulating The Regulators - Reducing Burdens On Small Business, Rena I. Steinzor

Rena I. Steinzor

No abstract provided.