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

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.

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 …

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 …

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’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 …

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

Rena I. Steinzor

No abstract provided.

Toward Adequacy, Sarah L. Brinton

Sarah L Brinton

Each year, hundreds of people, companies, organizations, and associations sue the federal government for injuries they have suffered at the hands of federal agencies. Such suits are often brought under the judicial review provisions of the Administrative Procedure Act (“APA”), which Congress enacted expressly to allow broad access to courts in an age of increasing administrative agency action. By the terms of the APA itself, all final agency action for which there is no other adequate remedy in a court is reviewable under the APA.

But the very language meant to welcome such suits into court also acts as a …

“Smut And Nothing But”: The Fcc, Indecency, And Regulatory Transformations In The Shadows, Lili Levi

Lili Levi

For almost a century, American broadcasting has received a lesser degree of constitutional protection than the print medium. Although many of the FCC’s regulations in “the public interest” have been upheld against First Amendment challenge on the ground that broadcasting is exceptional, the traditional reasons given for such exceptionalism – scarcity and pervasiveness – have become increasingly careworn. Fighting that consensus, the FCC has aggressively pursued the regulation of indecency on radio and television since 2003. When the FCC’s enhanced indecency prohibitions swept up U2 front-man Bono’s fleeting expletive on a music awards show, broadcasters finally thought they had found …

Climate Change And Water Transfers, Christine A. Klein

Christine A. Klein

Climate change adaption is all about water. Although some governments have begun to plan for severe water disruptions, many have not. The consequences of inaction, however, may be dire. As a report of the U.N. Environment Programme warns, “countries that adopt a ‘wait and see’ approach potentially risk the lives of their people, their ecosystems and their economies.” In the United States, according to one study, nearly 60% of the states are unprepared to deal with the impending crisis. Responding to this void, we offer what we believe is the first comprehensive, state-by-state survey of water allocation law and its …

The Jurisdiction Of The D.C. Circuit, Eric M. Fraser, David K. Kessler, Matthew Lawrence, Stephen A. Calhoun

Matthew B. Lawrence

The Implausibility Of Secrecy, Mark Fenster

Mark Fenster

Government secrecy frequently fails. Despite the executive branch’s obsessive hoarding of certain kinds of documents and its constitutional authority to do so, recent high-profile events—among them the WikiLeaks episode, the Obama administration’s celebrated leak prosecutions, and the widespread disclosure by high-level officials of flattering confidential information to sympathetic reporters—undercut the image of a state that can classify and control its information. The effort to control government information requires human, bureaucratic, technological, and textual mechanisms that regularly founder or collapse in an administrative state, sometimes immediately and sometimes after an interval. Leaks, mistakes, open sources—each of these constitutes a path out …

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 …

Brief For Cato Institute Et Al. As Amici Curiae Supporting Petitioners, City Of Arlington Texas Et Al. V. Federal Communications Commission Et Al., Daniel A. Lyons, Jonathon H. Adler, Roderick M. Hills

Daniel Lyons

No abstract provided.

Health Law And Administrative Law: A Marriage Most Convenient, Timothy Stoltzfus Jost

Timothy S. Jost

This symposium explores the complex relationship between health law and administrative law. It is based on the observation that these two fields of law are peculiarly intertwined. It attempts to understand why this is so, as well as whether it is necessary and whether it is desirable. Would we as a society, that is, be better off if health law were less permeated by administrative law? Even if we would be better off, is it indeed possible to extricate health law from administrative law? This essay begins by defining health law and administrative law. It then proceeds to describe the …

The End Game Of Deregulation: Myopic Risk Management And The Next Catastrophe, Thomas O. Mcgarity, Rena I. Steinzor

Rena I. Steinzor

On December 22, 2008, the contents of an enormous impoundment containing coal-ash slurry from the Tennessee Valley Authority’s (TVA) Kingston Fossil Fuel Plant poured into the Emory River. The proximate cause of the spill was the bursting of a poorly reinforced dike holding back a pit of sludge that towered 80 feet above the river and 40 feet above an adjacent road. The volume and force of the spill were so large that 1.1 billion gallons of the inky mess flowed across the river, inundating 300 acres of land in a layer four to five feet deep, uprooting trees, destroying …

The Geography Of Racial Stereotyping: Evidence And Implications For Vra Preclearance After Shelby County, Christopher Elmendorf, Douglas Spencer

Christopher S. Elmendorf

The Supreme Court in Shelby County v. Holder (2013) effectively enjoined the preclearance regime of the Voting Rights Act. The Court deemed the coverage formula, which determines the jurisdictions subject to preclearance, insufficiently grounded in current conditions. This paper proposes a new, legally defensible approach to coverage based on between-state differences in the proportion of voting age citizens who subscribe to negative stereotypes about racial minorities and vote accordingly. The new coverage formula could also account for racially polarized voting and minority population size, but, for constitutional reasons, subjective discrimination by voters is the essential criterion. We demonstrate that the …

The Senate And The Recess Appointments, David Arkush

David J. Arkush

This Essay offers a new perspective on the recess appointments controversy in Noel Canning v. NLRB. First, contrary to the dominant view, the case does not present a conflict between the President and the Senate. The Senate majority likely wished to authorize the President's recess appointments, and the majority is the relevant body for the purpose of establishing Senate intent. Second, the courts should defer to the Senate's wishes rather than define the term "recess" themselves.

Skating Too Close To The Edge: A Cautionary Tale For Tax Practitioners About The Hazards Of Waiver, Claudine Pease-Wingenter

Claudine Pease-Wingenter

The Federal Rules of Evidence defer to common law in establishing the rules of attorney-client privilege. As a general matter, such an approach creates a fairly uncertain legal landscape as each court articulates the baseline rules somewhat differently. The varied judicial applications of those differing rules can then exacerbate the uncertainty even more.

Unfortunately, in the area of tax law, the rules and their application are particularly uncertain because attorneys and accountants have overlapping responsibilities to clients and the courts have historically refused to recognize an accountant-client privilege. During my approximately eight years practicing corporate tax law, I was acutely …

Mirror, Mirror On The Wall: Stigma And Denial In Social Security Disability Hearings, Chris E. Pashler

Chris E Pashler

Commentators have recently suggested that the Social Security Administration (SSA) abandon its non-adversarial model of adjudication utilized in the disability hearings process in favor of an adversarial system, where the United States would be represented by an attorney. This Article will argue that such measures are not necessary to provide the claimant with a full and fair hearing, and will not lead to more consistent or accurate outcomes. Rather, this Article will argue that adoption of an adversarial model of adjudication will radically transform the nature of the disability adjudication process. This potential shift in the character of the hearings …