Digital Commons Network^™

What Do We Worry About When We Worry About Price Discrimination? The Law And Ethics Of Using Personal Information For Pricing, Akiva A. Miller

Akiva A Miller

New information technologies have dramatically increased sellers’ ability to engage in retail price discrimination. Debates over using personal information for price discrimination frequently treat it as a single problem, and are not sufficiently sensitive to the variety of price discrimination practices, the different kinds of information they require in order to succeed, and the different ethical concerns they raise. This paper explores the ethical and legal debate over regulating price discrimination facilitated by consumers’ personal information. Various kinds of “privacy remedies”—self-regulation, technological fixes, state regulation, and legislating private causes of legal action—each have their place. By drawing distinctions between various …

E-Commerce And Electronic Payment System Risks: Lessons From Paypal, Lawrence J. Trautman

Lawrence J. Trautman Sr.

What are the major risks perceived by those engaged in e-commerce and electronic payment systems? What development risks, if they become reality, may cause substantial increases in operating costs or threaten the very survival of the enterprise? This article utilizes the relevant annual report disclosures from eBay (parent of PayPal), along with other eBay and PayPal documents, as a potentially powerful teaching device. Most of the descriptive language to follow is excerpted directly from eBay’s regulatory filings. My additions include weaving these materials into a logical presentation and providing supplemental sources for those who desire a deeper look (usually in …

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. …

Navigating Through The Fog Of Cloud Computing Contracts, T. Noble Foster

T. Noble Foster

This paper explores legal issues associated with cloud computing, provides analysis and commentary on typical clauses found in contracts offered by well-known cloud service providers, and identifies strategies to mitigate the risk of exposure to cloud-based legal claims in the critical areas of data security, privacy, and confidentiality. While current research offers numerous case studies, viewpoints, and technical descriptions of cloud processes, our research provides a close examination of the language used in cloud contract terms. Analysis of these contract terms supports the finding that most standard cloud computing contracts are unevenly balanced in favor of the cloud service provider. …

Law And Order On A Beer Mat: Law, Interdisciplinarity And Expertise, Nicolette M. Priaulx, Martin Weinel

Nicolette M Priaulx

In this paper we seek to offer an original theoretical platform for thinking about the nature of legal knowledge produced through ‘legal interdisciplinarity’. The context for our discussion is the emergence of a ‘behavioural boom’ in the field of law where researchers increasingly turn to fields like behavioural economics to encourage shifts in legal and social governance architecture. Using a case study which explores the application of a sub-branch of psychology to civil law, we highlight serious concerns attending the capacity of lone legal researchers to meaningfully navigate non-legal domains. Central to our analysis, is the sociology of expertise and …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Taming A Dragon: Legislative History In Legal Analysis, Mark Deforrest

Mark DeForrest

ARTICLE ABSTRACT

TAMING A DRAGON:

LEGISLATIVE HISTORY IN LEGAL ANALYSIS

Mark DeForrest

The use of legislative history in statutory interpretation and analysis has been an area of intensive inquiry since the 1980’s. The debate has been vigorous and has led to the development of sophisticated arguments by both the advocates of the use of legislative history and textualists critical of its use. While the debate has been ongoing, changes in technology have made it easier than ever to access detailed legislative history for both state and federal statutes. This article discusses the impact of both the debate and the technological …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

Voir Dire And Frye-Daubert Hearings: Choosing The Proper Tool, Kenneth Sanders, Geoffrey Sanders

Kenneth L Sanders MD

Attack and defense of scientific evidence and expert testimony through Frye-Daubert and voir dire hearings is potentially game changing. Counsel should conceptualize and organize the similarities and differences of each category of scientific/medical hearing.

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Book Review: Carl Cranor, Toxic Torts: Science, Law, And The Possibility Of Justice, David Caudill

David S Caudill

Carl F. Cranor’s Toxic Torts: Science, Law, and the Possibility of Justice is a sustained, comprehensive argument that the Daubert gatekeeping regime has tilted the playing field against injured plaintiffs in toxic tort litigation. More generally, Cranor joins those who argue that the Daubert regime has not fared well in practice. Complex scientific evidence is not handled well in trials because scientific methods, data, and inferential reasoning are not well understood by gatekeeping judges. Cranor’s goal is to help solve this problem by offering a detailed description of the patterns of reasoning, evidence collection, and inference in nonlegal scientific settings. …

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 …

Science And Compliance In The Arctic: A Constructivist Approach To The Un Commission On The Limits Of The Continental Shelf, Sari M. Graben, Peter Harrison

Sari M Graben

The United Nations Commission on the Limits of the Continental Shelf is expected to play an essential role in delineating the rights of the Arctic states to sea bed resources in the Arctic Ocean. Positivist theories of international law generally source Arctic state compliance to the binding effect of Article 76 of the UN Convention on the Law of the Sea. However, positivist explanations fail to answer why the Arctic states, which are authorized to establish their own limits, would accept the sovereignty costs associated with the Commission’s legal and scientific interpretations. In order to better understand how the Commission …

Choosing The Genetic Makeup Of Children: Our Eugenics Past-Present, And Future?, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Patent Trolls Among Us, Kent R. Acheson

Kent R Acheson

As Acheson (2012) suggested in A Study of the Need to Change United States Patent Policy, software should not be patented, but the Intellectual Property Rights should be protected in another manner that does not entail a Copyright, Trademark, or secrecy. A new form of protection should be created based on certain criteria, such as useful life of a patent, incremental innovation, value to society, and or value to life.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

Taking Genomics To The Bio Bank: Access To Human Biological Samples And Medical Information, Michael J. Malinowski

Michael J. Malinowski

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.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski

Michael J. Malinowski

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 …

The Extraterritoriality Of Eu Data Privacy Law - Its Theoretical Justification And Its Practical Effect On U.S. Businesses, Dan Jerker B. Svantesson

Dan Svantesson

Due to its extraterritorial effect, the European Union’s trailblazing data privacy law has long been a major concern for U.S. businesses. With the proposal for a new data privacy framework in the EU, with potential penalties of up to 2% of an offending enterprise’s annual worldwide turnover, such concerns are justified indeed; particularly as the EU at the same time seems to be expanding the extraterritorial reach of its data privacy law.

This article examines the extraterritoriality of current and proposed EU data privacy law and analyses whether those claims of extraterritoriality can be either justified or objected to by …

R2dford: Autonomous Vehicles And The Legal Implications Of Varying Liability Structures, Alexander P. Herd

Alexander P Herd

The World Health Organization estimates that by 2030, traffic accidents will be the fifth leading cause of death in the world. Thus when Google announced that it had designed an autonomous car which could reduce traffic accidents by as much as ninety percent, there was cause for excitement. Some states have already started legislation to permit the use of autonomous cars in anticipation of the release later this decade. Courts and lawmakers need to consider who will be liable when the car that drives itself crashes. Standards used in aviation and naval cases regarding auto-pilot can be applied to the …

From Gridlock To Groundbreaking: Realizing Reliability In Forensic Science, Jessica D. Gabel

Jessica Gabel Cino

In 2009, The National Academy of Sciences published a scathing report announcing that forensic science is broken and needs to be overhauled. Weaknesses have plagued forensic evidence for decades, and the resulting legal challenges have been hard fought but met with few victories. What we do know is a harsh truth: that faulty forensic science has contributed to the conviction of innocent people—and will continue to do so if the status quo persists.

In recent years, the reality of wrongful convictions has become mainstream through the work of the Innocence Project and other organizations. Out of the 305 DNA-based exonerations …

The Surveillance Society And The Third-Party Privacy Problem, Shaun Spencer

Shaun Spencer

This article examines a question that has become increasingly important in the emerging surveillance society: should the law treat information as private even though others know about it? This is the third-party privacy problem. Part I explores two competing conceptions of privacy: the binary and contextual conceptions. Part II describes two features of the emerging surveillance society that should change the way we address the third-party privacy problem. One feature, “surveillance on demand,” results from exponential increases in data collection and aggregation. The other feature, “uploaded lives,” reflects a revolution in the type and amount of information that we share …