Digital Commons Network^™

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Troika Of Single Particle Tracking Programing: Snr Enhancement, Particle Identification, And Mapping, Lydia Kisley

Faculty Scholarship

Single particle tracking (SPT) techniques provide a microscopic approach to probe in vivo and in vitro structure and reactions. Automatic analysis of SPT data with high efficiency and accuracy spurs the development of SPT algorithms. In this perspective, we review a range of available techniques used in SPT analysis programs. In addition, we present an example SPT program step-by-step to provide a guide so that researchers can use, modify, and/or write a SPT program for their own purposes. © 2014 the Owner Societies.

Do Npes Matter? Non-Practicing Entities And Patent Litigation Outcomes, Michael J. Mazzeo, Jonathan H. Ashtor, Samantha Zyontz

Faculty Scholarship

It is widely argued that so-called “patent trolls” are corrupting the U.S. patent system and endangering technology innovation and commercialization at large. For example, a recent White House report argued that “trolls” hurt firms of all sizes and advocated for specific policies aimed at curtailing practices thought to be particularly harmful. Yet the existence and extent of any systematic effects of so-called “troll-like” behavior, and the implications of modern patent assertion practices by Non-Practicing Entities (“NPEs”), remains unclear. This article develops novel empirical evidence to inform the debate over NPEs on patent litigation. Specifically, we conduct a large-scale empirical analysis …

Reflections On The Cost Of "Low-Cost" Whole Genome Sequencing: Framing The Health Policy Debate, Timothy Caulfield, Jim Evans, Amy Mcguire, Christopher Mccabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A. Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K. Cho, June C. Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jim Lee, Karen H. Rothenberg, Pamela Sankar, Michael J. Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J. Ungar, Brenda Wilson

Faculty Scholarship

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

Educating Main Street Lawyers, Luz E. Herrera

Faculty Scholarship

Discussion about the value of a law degree has focused on the financial success of lawyers. Both defenders and critics of the existing legal education model largely ignore the implications that the cost of legal education and high lawyer fees have on access to justice. While a lawyer’s ability to make a decent living must be addressed when determining the value of a legal education, we fail to take into account the fact that there are millions of individuals in the U.S. who cannot find a lawyer to represent them when they need one. For advocates who believe that our …

How Much Is That Lawsuit In The Window; Pricing Legal Claims, Maya Steinitz

Faculty Scholarship

This article poses the question: How should parties to litigation finance agreements – third party funding or contingency fees – deal with the inherent difficulty in pricing legal claims? It answers that a practical solution would be to use staged funding. Staged funding side-step the impossibility of accurately pricing litigation ex ante by allowing re-pricing and exit that are pegged to information disclosure. Done right, staging allows all parties to minimize the effects of uncertainty, better price their bargain, optimize the distribution of the proceeds of litigation between its different investors – far beyond practices common today. Staged funding also …

The Inclusiveness Of The New Originalism, James E. Fleming

Faculty Scholarship

In tracing the arc of originalism from the old originalism to the new, I observe a shift from an exclusionary outlook to an inclusionary outlook, reflected in new originalists’ proclamations that “we are all originalists now.” As my title suggests, I am going to bring out the inclusiveness of the new originalism and ponder its implications. The new originalists have emphasized two developments: (1) the movement from a focus on “intention of the framers” to “original public meaning” and (2) the articulation of and emphasis on the distinction between interpretation and construction. My main points are two. First, the inclusiveness …

The Right To Quantitative Privacy, David Gray, Danielle K. Citron

Faculty Scholarship

We are at the cusp of a historic shift in our conceptions of the Fourth Amendment driven by dramatic advances in surveillance technology. Governments and their private sector agents continue to invest billions of dollars in massive data-mining projects, advanced analytics, fusion centers, and aerial drones, all without serious consideration of the constitutional issues that these technologies raise. In United States v. Jones, the Supreme Court signaled an end to its silent acquiescence in this expanding surveillance state. In that case, five justices signed concurring opinions defending a revolutionary proposition: that citizens have Fourth Amendment interests in substantial quantities of …

Social Dynamics In Mixed-Income Developments, Mark L. Joseph, Taryn Gress

Faculty Scholarship

This report, the first “State of the Field Scan” from the newly launched National Initiative on Mixed-Income Communities at Case Western Reserve University (NIMC), is the first effort to conduct a data collection effort across a broad set of mixed-income developments nationwide. The goals of these State of the Field Scans are to: 1. generate a comparative description of the landscape of the mixed-income development field, 2. collect and analyze perceptions, experiences and insights from mixed-income practitioners on specific topics of pressing interest to the field, and 3. make contact and build relationships with a network of mixed-income developments and …

Bill Suter: General, Ambassador, Tulanian, David D. Meyer

Faculty Scholarship

No abstract provided.

Falling Behind: Processing And Enforcing Permits For Animal Agriculture Operations In Maryland Is Lagging, Rena I. Steinzor, Anne Havemann

Faculty Scholarship

After decades of failed interstate agreements, the Chesapeake Bay is choking on too many nutrients. The estuary’s last, best chance of recovery is the Environmental Protection Agency's Total Maximum Daily Load (“TMDL”) program, also known as a pollution diet. To meet this deadline, all polluters, including large animal farms, will need to sharply reduce the pollutants they release into the Bay. The Maryland Department of the Environment (MDE) must ensure that each Concentrated Animal Feeding Operation (“CAFO”) has developed a facility-specific permit that details when and where manure is applied to fields and how waste is stored and handled. Then …

Dynamic Expansion, Nicole Huberfeld

Faculty Scholarship

Nearly one in four Americans will have medical care and costs covered by the Medicaid program when it has been expanded pursuant to the Patient Protection and Affordable Care Act (the ACA). National media outlets have been reporting that only about half of the states are participating in the Medicaid expansion; if the reports were true, millions of Americans would be left without insurance coverage, and many of the nation’s medically fragile citizens would not have access to consistent healthcare. Contrary to these reports, most states will participate in the Medicaid expansion in the near future. This claim is not …

Global Health And Human Rights: Legal And Philosophical Perspectives; The Right To Health In International Law, Erika George

Faculty Scholarship

John Harrington and Maria Stuttaford (eds). Global Health and Human Rights: Legal and Philosophical Perspectives. New York: Routledge, 2010. Pp. 232. £85 (pbk £24.99). ISBN: 9780415479387.

John Tobin. The Right to Health in International Law. New York: Oxford University Press, 2012. Pp. 440. £74. ISBN: 9780199603299.

Two recent publications present a defence of the right to health as it is articulated in international law and also provide insights into the array of impediments to realizing the health right. Despite a perceived conceptual lack of coherence and a limited appreciation of its relevance among health care professionals identified in …

Navajo Nation Labor Commission Appellants' Opening Brief, Paul Spruhan

Faculty Scholarship

The District Court erred when it concluded the Navajo Nation’s employment jurisdiction over the school districts was “plainly lacking,” and the Court was required to stay or dismiss the case pending the school districts’ exhaustion of its remedies in the Navajo Nation courts. Under the plainly lacking exception, this Court requires exhaustion of tribal remedies when jurisdiction is “plausible” or “colorable.” Under the circumstances of the case, which concerns treaty rights, tribal-state relations, and the fact-intensive rules of Montana v. United States, 450 U.S. 544 (1981), the District Court could not have made that determination without a robust factual …

Probiotics: Finding The Right Regulatory Balance, Diane E. Hoffmann, Claire M. Fraser-Liggett, Frank B. Palumbo, Jacques Ravel, Karen H. Rothenberg, Virginia Rowthorn

Faculty Scholarship

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated.

Contractually Adopted Fiduciary Duty, D. Gordon Smith

Faculty Scholarship

The Delaware Supreme Court recently referred to “contractually adopted fiduciary duties.” Although some commentators, including Larry Ribstein, view fiduciary duties as a type of contract term, the notion of contractually adopted fiduciary duties is incoherent. The need to opt in to fiduciary duties would arise in only two circumstances: (1) fiduciary relationships that do not invoke fiduciary duties without contractual authorization, and (2) nonfiduciary relationships in which the parties wish to invoke fiduciary duties that would otherwise be absent. The first category of relationships does not exist, as courts impose fiduciary duties when the structure of a relationship indicates that …

Transfer Pricing: Un Guidelines — Brazil, Richard Thompson Ainsworth

Faculty Scholarship

The UN Practical Manual on Transfer Pricing for Developing Countries endeavors to provide “clearer guidance on the policy and administrative aspects of applying transfer pricing analysis.” Chapter 10 is particularly noteworthy. It sets out specific country practices. The rules in Brazil, China, India and South Africa are offered as templates for developing countries to follow.

This article considers the Brazilian contribution to Chapter 10. Although some writers believe that developing countries should adopt the Brazilian model this article suggests otherwise. Even though it is a theoretically simple system, some aspects of the Brazilian model consistently work to the fiscal disadvantage …

The Kalman Filter For Linear Systems On Time Scales, Martin Bohner, Nick Wintz

Faculty Scholarship

We introduce the Kalman filter for linear systems on time scales, which includes the discrete and continuous versions as special cases. When the system is also stochastic, we show that the Kalman filter is an observer that estimates the system when the state is corrupted by noisy measurements. Finally, we show that the duality of the Kalman filter and the Linear Quadratic Regulator (LQR) is preserved in their unification on time scales. A numerical example is provided.

The Dynamic Sustainability Framework: Addressing The Paradox Of Sustainment Amid Ongoing Change, Kurt C. Stange

Faculty Scholarship

Background: Despite growth in implementation research, limited scientific attention has focused on understanding and improving sustainability of health interventions. Models of sustainability have been evolving to reflect challenges in the fit between intervention and context.Discussion: We examine the development of concepts of sustainability, and respond to two frequent assumptions -'voltage drop,' whereby interventions are expected to yield lower benefits as they move from efficacy to effectiveness to implementation and sustainability, and 'program drift,' whereby deviation from manualized protocols is assumed to decrease benefit. We posit that these assumptions limit opportunities to improve care, and instead argue for understanding the changing …

Defining The Vulnerable Period For Re-Establishment Of Clostridium Difficile Colonization After Treatment Of C. Difficile Infection With Oral Vancomycin Or Metronidazole, Venkata C.K. Sunkesula, Sirisha Kundrapu, Robin L. Jump, Curtis J. Donskey

Faculty Scholarship

Background:Clostridium difficile is an anaerobic, spore-forming bacterium that is the most common cause of healthcare-associated diarrhea in developed countries. A significant proportion of patients receiving oral vancomycin or metronidazole for treatment of Clostridium difficile infection (CDI) develop recurrences. However, the period of vulnerability to re-establishment of colonization by C. difficile after therapy is not well defined.Principal Findings:In a prospective study of CDI patients, we demonstrated that most vancomycin-treated patients maintained inhibitory concentrations of vancomycin in stool for 4 to 5 days after therapy, whereas metronidazole was only detectable during therapy. From the time of elimination of the antibiotics to 14 …

On Duopoly And Compensation Games In The Credit Rating Industry, Robert J. Rhee

Faculty Scholarship

Credit rating agencies are important institutions of the global capital markets. If they had performed properly, the financial crisis of 2008–2009 would not have occurred, and the course of world history would have been different. There is a near universal consensus that reform is needed, but none as to the best approach. The problem has not been solved. This Article offers the simplest fix proposed thus far, and it is contrarian. Unlike other reform proposals, this Article accepts the central role of rating agencies in the regulation of bond investments, the realities of a duopoly, and the issuer-pay model of …

Citizen Engagement In The Shrinking City: Toward Development Justice In An Era Of Growing Inequality, Barbara L. Bezdek

Faculty Scholarship

What are the aims of the revitalization conducted by local officials: for which social goods? Good for whom? By what means can the city’s people understand and influence the tradeoffs made by their government in the redevelopment of city blocks already occupied by residents. This is more than a matter of development finance or physical redevelopment. It is a question of social justice, of whose reality counts in the legal process utilized to reach development decisions and approve significant public subsidy for the projects that are remaking American cities.

Sherry Arnstein, writing in 1969 about citizen involvement in planning processes …

2013 Survey Of Juvenile Law, Michael J. Dale

Faculty Scholarship

No abstract provided.

Using The Client-File Method To Teach Transactional Law, Bradley T. Borden

Faculty Scholarship

No abstract provided.

Trick Or Treat: The Application Of The State Udap Statutes To Government Agencies In The Florida Dependency Process, Michael Flynn

Faculty Scholarship

No abstract provided.

From The Editor: Passing The Torch, Janet Sinder

Faculty Scholarship

No abstract provided.

The Tropics Exploited: Risk Preparedness And Corporate Social Responsibility In Offshore Energy Development, Nadia B. Ahmad

Faculty Scholarship

No abstract provided.

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

The Dangerous Law Of Biological Race, Khiara Bridges

Faculty Scholarship

The idea of biological race -- a conception of race that postulates that racial groups are distinct, genetically homogenous units -- has experienced a dramatic resurgence in popularity in recent years. It is commonly understood, however, that the U.S. Supreme Court has rejected the idea that races are genetically uniform groupings of individuals. Almost a century ago, the Court famously appeared to recognize the socially constructed nature of race. Moreover, the jurisprudence since then appears to reaffirm this disbelief: within law, race is understood to be a social construction, having no biological truth to it at all. Yet upon closer …

Central Falls Retirees V. Bondholders: Assessing Fear Of Contagion In Chapter 9 Proceedings, Maria O'Brien

Faculty Scholarship

Modern Chapter 9 litigation has been characterized by extraordinary protections for municipal bondholders, and Central Falls is no exception. Although not well understood by politicians, fear of contagion has encouraged the adoption of legal arrangements that have limited the bankruptcy courts’ ability to include bondholders in the cost of restructuring municipal debt. This preference for bondholders (and, by extension, their insurers) has meant increased misery for taxpayers and retirees. Given that all of these actors appear to have been complicit to some degree in the creation and maintenance of the fiscally imprudent conditions that triggered bankruptcy and that evidence of …