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Articles 1 - 17 of 17
Full-Text Articles in Law
Of Speech And Sanctions: Toward A Penalty-Sensitive Approach To The First Amendment, Michael Coenen
Of Speech And Sanctions: Toward A Penalty-Sensitive Approach To The First Amendment, Michael Coenen
Journal Articles
Courts confronting First Amendment claims do not often scrutinize the severity of a speaker’s punishment. Embracing a “penalty-neutral” understanding of the free-speech right, these courts tend to treat an individual’s expression as either protected, in which case the government may not punish it at all, or unprotected, in which case the government may punish it to a very great degree. There is, however, a small but important body of “penalty-sensitive” case law that runs counter to the penalty-neutral norm. Within this case law, the severity of a speaker’s punishment affects the merits of her First Amendment claim, thus giving rise …
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
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
Journal Articles
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 …
Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski
Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski
Journal Articles
The roles of government, industry, and academia in science research have been recast repeatedly since the U.S. began infusing tremendous funding during WWII. Recently, the National Institutes of Health (NIH) proposed a billion-dollar center to intervene in commercial drug development with the objective of lifting it out of a frightening fifteen-year slump in productivity. This article questions the role of the U.S. government in pharmaceutical development after completion of a map of the human genome (the touchstone of the Human Genome Project, HGP), a research undertaking spearheaded by the U.S. Government that spanned more than a decade. Specifically, the article …
Finding Room For Fairness In Formalism--The Sliding Scale Approach To Unconscionability, Melissa T. Lonegrass
Finding Room For Fairness In Formalism--The Sliding Scale Approach To Unconscionability, Melissa T. Lonegrass
Journal Articles
This Article evaluates the sliding scale approach to unconscionability, defends its use, and advocates for its continued and expanded application to consumer standard form contracts. Part I describes the sliding scale approach and its recent popularity in state courts, thereby filling a gap in the scholarly doctrine, which has to date failed to fully examine this trend. Parts II and III defend the sliding scale approach, praising its potential to align the unconscionability analysis with interdisciplinary research regarding consumer behavior and to balance formalist concerns about judicial regulation of unfair terms in standard form contracts. Finally, Part IV calls for …
All That Is Gold Does Not Glitter In Human Clinical Research: A Law– Policy Proposal To Brighten The Global “Gold Standard” For Drug Research And Development, Michael J. Malinowski, Grant G. Gautreaux
All That Is Gold Does Not Glitter In Human Clinical Research: A Law– Policy Proposal To Brighten The Global “Gold Standard” For Drug Research And Development, Michael J. Malinowski, Grant G. Gautreaux
Journal Articles
This Article challenges the global science standard for putting new drugs on pharmacy shelves. The primary premise is that the “gold standard” of group experimental design is an antiquated extension of drug development’s crude-science past, and is inconsistent with the precision of contemporary genetics— the science that increasingly dominates the drug development pipeline. The Article identifies law– policy options that would raise the standard for human clinical research under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
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
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
Journal Articles
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. …
Adversarial No More: How Sua Sponte Assertion Of Affirmative Defenses To Habeas Wreaks Havoc On The Rules Of Civil Procedure, Katherine Macfarlane
Adversarial No More: How Sua Sponte Assertion Of Affirmative Defenses To Habeas Wreaks Havoc On The Rules Of Civil Procedure, Katherine Macfarlane
Journal Articles
In every federal civil case, a defendant must raise its affirmative defenses in the pleading that responds to a plaintiff's complaint. According to Federal Rule of Civil Procedure 8(c), failure to properly plead, for example, a statute of limitations defense, waives the defense for good. Rule 8(c) does not exempt any category of affirmative defense, nor does it forgive unintentional omissions of certain defenses. It also does not prefer governmental defendants to others. Yet in habeas corpus cases, the most significant affirmative defenses to habeas petitions need not comply with Rule 8(c). Instead, federal courts may raise the affirmative defenses …
Federal Constitutions: The Keystone Of Nested Commons Governance, Blake Hudson
Federal Constitutions: The Keystone Of Nested Commons Governance, Blake Hudson
Journal Articles
The constitutional structure of a federal system of government can undermine effective natural capital management across scales, from local to global. Federal constitutions that grant subnational governments virtually exclusive regulatory authority over certain types of natural capital appropriation — such as resources appropriated by private forest management or other land-use-related economic development activities — entrench a legally defensible natural capital commons in those jurisdictions. For example, the same constitution that may legally facilitate poor forest-management practices by private landowners in the southeastern United States may complicate international negotiations related to forest management and climate change. Both the local and international …
Fail-Safe Federalism And Climate Change: The Case Of U.S. And Canadian Forest Policy, Blake Hudson
Fail-Safe Federalism And Climate Change: The Case Of U.S. And Canadian Forest Policy, Blake Hudson
Journal Articles
Recent research demonstrates the difficulties that federal systems of government may present for international treaty formation, a prime example being legally binding treaties aimed at harnessing global forests to regulate climate change. Some federal constitutions, such as the U.S. and Canadian constitutions, grant subnational governments virtually exclusive direct forest management regulatory authority for non-federally owned forests. With subnational governments controlling sixty-five percent of forests in the United States and eighty-four percent in Canada, the U.S. and Canadian federal governments may be constrained during international negotiations and unable to legally bind subnational governments to any agreement prescribing methods of utilizing these …
Federal Constitutions, Global Governance, And The Role Of Forests In Regulating Climate Change, Blake Hudson
Federal Constitutions, Global Governance, And The Role Of Forests In Regulating Climate Change, Blake Hudson
Journal Articles
Federal systems of government present more difficulties for international treaty formation than perhaps any other form of governance. Federal constitutions that grant subnational governments virtually exclusive regulatory authority over certain subject matter may constrain national governments during international negotiations - a national government that cannot constitutionally bind subnational governments to an international agreement cannot freely arrange its international obligations. While federal nations that grant subnational governments exclusive regulatory control obviously place value on stringent decentralization and the benefits it provides in those regulatory areas, the difficulty lies in striking a balance between global governance and constitutional decentralization in federal systems. …
Coastal Land Loss And The Mitigation-Adaptation Dilemma: Between Scylla And Charybdis, Blake Hudson
Coastal Land Loss And The Mitigation-Adaptation Dilemma: Between Scylla And Charybdis, Blake Hudson
Journal Articles
Coastal land loss is an inevitable consequence of the confluence of three primary factors: population growth, vanishing wetlands, and rising sea levels. Society may either mitigate coastal land loss by engaging in human engineering projects that create technological solutions or restore natural processes that protect the coastal zone, or it may choose to adapt to coastal land loss by shifting development and other human and economic resources out of areas especially at risk for coastal land loss. This Article first details the primary threats to coastal lands. Next, the Article discusses two primary means of addressing coastal land loss — …
New Life For The Death Tax Debate, Elizabeth Carter
New Life For The Death Tax Debate, Elizabeth Carter
Journal Articles
This article examines the ascendancy of wealth redistribution as the policy underpinning the federal estate tax through the lens of sociology and argues that, by attempting to ensure equal access to the American dream by penalizing only those who have fulfilled its promise, the federal estate tax places fundamental American values in irreconcilable conflict. The reason that the current system does not work, I argue, is rooted more in history and sociology than it is in economics. The solution is not necessarily the repeal of the federal estate tax. Nor is the solution replacing the estate tax with an inheritance …
Annexation And The Mid-Size Metropolis: New Insights In The Age Of Mobile Capital, Christopher J. Tyson
Annexation And The Mid-Size Metropolis: New Insights In The Age Of Mobile Capital, Christopher J. Tyson
Journal Articles
Metropolitan regions are led by their central cities. They want and need to grow, but the suburban sprawl and municipal fragmentation that growth produces stand in the way. Fragmentation handicaps the central city’s ability to effectively coordinate responses to regional issues. Mid-size regions are especially vulnerable to the effects of fragmentation, as they face unique economic development and sociological challenges. First, mid-size regions lack many of the assets necessary to compete globally for mobile capital. Second, social inequality plays out differently in mid-size regions, which are spatially constrained and have pervasive low-density land use patterns. Municipal boundaries reflect these divisions …
Localism And Involuntary Annexation: Reconsidering Approaches To New Regionalism, Christopher J. Tyson
Localism And Involuntary Annexation: Reconsidering Approaches To New Regionalism, Christopher J. Tyson
Journal Articles
No abstract provided.
Louisiana Oil & Gas Update, Keith B. Hall
From Agnatic Succession To Absolute Primogeniture: The Shift To Equal Rights Of Succession To Thrones And Titles In The Modern European Constitutional Monarchy, Christine Corcos
From Agnatic Succession To Absolute Primogeniture: The Shift To Equal Rights Of Succession To Thrones And Titles In The Modern European Constitutional Monarchy, Christine Corcos
Journal Articles
No abstract provided.
The Hurricane Katrina Levee Breach Litigation: Getting The First Geoengineering Liability Case Right, Edward P. Richards
The Hurricane Katrina Levee Breach Litigation: Getting The First Geoengineering Liability Case Right, Edward P. Richards
Journal Articles
No abstract provided.