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. …

Seeking Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese, Richard Zeckhauser, Edward Parson

Edward A Parson

Whether regulating mutual funds or chemical manufacturers, government's policy decisions depend on information possessed by industry. Yet it is not in any industry's interests to share information that will lead to costly regulations. So how do government regulators secure needed information from industry? Since information disclosed by any firm cannot be retrieved and can be used to regulate the entire sector, industry faces a collective action problem in maintaining silence. While collective silence is easy to maintain if all firms' interests are aligned, individual firms' payoffs for disclosure can vary due to heterogeneous effects of regulation and differing expectations about …

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

Community Supported Agriculture And Community Labor: Constructing A New Model To Unite Volunteers And Employers, A. Bryan Endres, Rachel Armstrong

A. Bryan Endres

Community Supported Agriculture (CSA) is a farm philosophy and marketing strategy that creates a union between consumers and farmers. Extending beyond the traditional buyer-seller relationship, CSA farmers invite customers to participate in food production in a variety of scenarios the authors refer to as “community labor.” But community labor entails a serious paradox. Traditional employment law doctrine envisions autonomous competition between laborer and employer, and makes little room for these novel, community-based relationships. More importantly, rigid application of employment law structures undermines many of the values embedded in the CSA movement and may limit its continued viability and growth. Constructed …

Utilizing Credit Reports For Employment Purposes: Casting A Wider Net Into The Ocean Of Employment Practices Results In Unintended Yet Much Needed Outcomes, David D. Schein, James D. Phillips

David D. Schein

In our previous article, “Holding Credit Reporting Agencies Accountable: How the Financial Crisis May be Contributing to Improving Accuracy in Credit Reporting”[1] we reviewed the legal history of the Fair Credit Reporting Act (FCRA) and its amendments, and the Federal case law by circuit. We suggested that the ability of consumers to ensure the accuracy and security of their credit reports might lead to an expansion of the litigation surrounding accurate credit reporting. This article takes the discussion further by exploring the ever-expanding use of credit reports in the employment law arena. We review the state legislation limiting the use …

The Supreme Court Of Canada's Decision In Ezokola And The Harmonisation Of Article 1f(A) Of The Convention On The Status Of Refugees With International Criminal Law, Alan W. Freckelton

Alan W Freckelton

Canadian appellate courts have historically taken a very wide view of when there are “serious reasons to believe” that a person has committed the kinds of offences envisaged by Article 1F(a) of the Convention. In particular, they have taken the view that, in some cases at least, mere membership of a particular group is sufficient to exclude a person from protection under the Convention. However, in Ezokola v Canada (Citizenship and Immigration) the Supreme Court has attempted to reconcile the requirements for responsibility for war crimes and crimes against humanity at international criminal law, and the requirements for exclusion under …

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 …

A Market For Tax Compliance, Walter E. Afield Iii

Walter E Afield III

It is becoming increasingly clear that, due to political realities and budgetary constraints, the IRS is going to have to attempt to enforce the tax laws by doing more with less. Current enforcement efforts have yielded a tax gap (i.e., the difference between the amount of taxes that should be paid and the amount that are collected) of roughly $450 billion annually. Faced with this task, one of the steps that the IRS has recently taken is to try to improve the quality in services performed by paid tax preparers, a group that historically has been subject to little IRS …

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 …

The Underutilized Foreign Investor, Griffin Weaver

Griffin Weaver

For most states, if not all, the push for economic advancement is at the front of every administration’s agenda. This is especially true for developing countries in the Middle East whose standard of living and international power is largely tied to its economic condition. An important indicator, if not condition, of a state’s economic health is the level of foreign direct investment (FDI) received by the state. This inflow of money is essential for the growth and stability of a state’s economy. As one U.S. official once noted, the United States “need[s] a net inflow of capital of $3 billion …

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 …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

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 …

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 …

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 …

Regulating For The Public Health: Perchlorate Regulation Under The Safe Drinking Water Act Exceeds Statutory Authority, Mary Jones

Mary Jones

This paper recommends rethinking the statutory framework of the Safe Drinking Water Act (SDWA) to provide a more robust rubric, to include a scientific and objective focus, for proper regulation. The SDWA is evaluated through the lens of upcoming perchlorate regulation due in February 2013.

The United States Environmental Protection Agency (EPA) regulates acceptable contaminant levels and decontamination processes for all public water systems, pursuant to statutory authority granted by the SDWA. Where the policy at work is admirable, the execution falls short.

Perchlorate occurs naturally, but also as a by-product to rocket fuel, firework, and other explosive constructions. Scientific …

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.