Digital Commons Network^™

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. …

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 …

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

Michael J. Malinowski

No abstract provided.

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 …

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 World As Our Technologist: Visualizing Worldwide Sources Of Technologies Patented In The United States, Richard S. Gruner

Richard S. Gruner

The World as Our Technologist: Visualizing Worldwide Sources

of Technologies Patented in the United States

by

Richard Gruner

Emeritus Professor of Law

John Marshall Law School

ABSTRACT

Patent rewards in the United States incentivize and attract the overseas development of many new technologies used in this country. The United States – as the world’s largest economy – is the primary driver of technology development worldwide. The strength of United States patent laws, court systems, and civil law enforcement processes ensure that parties who produce new inventions of commercial value and who patent and popularize the inventions in the United States …

Incentives Must Change: Addressing The Unpredictability Of Reasonable Royalty Damages, Daniel Mcmanus

daniel mcmanus

ABSTRACT

INCENTIVES MUST CHANGE: ADDRESSING THE UNPREDICTABILITY OF REASONABLE ROYALTY DAMAGES

Current law encourages patentees and defendants in a patent infringement suit to make the most widely varying arguments for reasonable royalty damages. The parties have so much discretion in presenting calculations for reasonable royalty damages that it is not uncommon for the patentee to request damages 80-100 times greater than the infringer’s proposed damages. Permitting so much discretion makes it highly unlikely that the resulting damages will be reasonable, and thus fails to achieve the goal of determining a reasonable royalty.

The problem is simple. Patents are difficult to …

Defying Dna: Rethinking The Role Of The Jury In An Age Of Scientific Proof Of Innocence, Andrea L. Roth

Andrea L Roth

In 1946, public outrage erupted after a jury ordered Charlie Chaplin to support a child who, according to apparently definitive blood tests, was not his. Half a century later, juries have again defied apparently definitive evidence of innocence, finding criminal defendants guilty based on a confession or eyewitness notwithstanding exculpatory DNA test results. One might expect judges in such cases to direct an acquittal, on grounds that the evidence is legally insufficient because no rational juror could find guilt beyond a reasonable doubt. Yet few if any do. Instead, courts defer to juries when they form an actual belief in …

Patents And The University, Peter Lee

Peter Lee

This Article advances two novel claims about the internalization of academic science within patent law and the concomitant evolution of “academic exceptionalism.” Historically, relations between patent law and the university were characterized by mutual exclusion, based in part on normative conflicts between academia and exclusive rights. These normative distinctions informed “academic exceptionalism”—the notion that the patent system should exclude the fruits of academic science or treat academic entities differently than other actors—in patent doctrine. As universities began to embrace patents, however, academic science has become internalized within the traditional commercial narrative of patent protection. Contemporary courts frequently invoke universities’ commercial …

Humans And Humans+: Technological Enhancement And Criminal Responsibility, Susan W. Brenner

Susan Brenner

This article examines the implications our use of technological enhancements to improve our physical and/or cognitive abilities will necessarily have on the processes of imposing criminal responsibility on those who victimize others. It explains that while our use of such enhancements is still in its infancy, it is more than likely that their use will dramatically accelerate over the next century or less. The articles examines how law has historically approached the concept of a “legal person,” with reference to “normal” humans, “abnormal” humans, animals, objects, supernatural beings and juristic persons. It also reviews how two other authors have analyzed …

The Davis Good Faith Rule And Getting Answers To The Questions Jones Left Open, Susan Freiwald

Susan Freiwald

The Supreme Court’s decision in United States v. Jones clearly established that use of GPS tracking surveillance constitutes a search under the Fourth Amendment. But the Court left many other questions unanswered about the nature and scope of the constitutional privacy right in location data. A review of lower court decisions in the wake of Jones reveals that, rather than begin to answer the questions that Jones left open, courts are largely avoiding substantive Fourth Amendment analysis of location data privacy. Instead, they are finding that officers who engaged in GPS tracking and related surveillance operated in good faith, based …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Keeping It Real: Using Facebook Posts To Teach Professionalism And Professional Responsibility, Anna P. Hemingway

Anna P. Hemingway

The Four Factor Test, Susan Freiwald

Susan Freiwald

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Emerging Technologies And Dwindling Speech, Jorge R. Roig

Jorge R Roig