Digital Commons Network^™

New Reproductive Technologies And The Inheritance Rights Of Unborn Children, Sharona Hoffman, Andrew Morriss

Andrew P. Morriss

No abstract provided.

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …

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 …

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 …

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 …

Harmonizing The Affordable Care Act (Obama Care) With The Three Main National Systems For Healthcare Quality Improvement: The Tort, Licensure And Hospital Peer Review Systems, K Van Tassel

Katharine A. Van Tassel

According to an estimate by the Institute of Medicine made over a decade ago, treatment errors in hospitals alone caused 98,000 deaths yearly. This IOM report is proving to be very conservative. A recent Consumer Reports investigation came to the conclusion that “[m]ore than 2.25 million Americans will probably die from medical harm this decade…. That’s like wiping out the entire populations of North Dakota, Rhode Island, and Vermont. It’s a manmade disaster.”

One of the reasons for this astonishing mortality rate is the normative practice of custom-based medicine in the United States. A large and rapidly growing group of …

Reforming Surveillance Law: The Swiss Model, Susan Freiwald, Sylvain Metille

Susan Freiwald

Reforming Surveillance Law: The Swiss Model

Susan Freiwald & Sylvain Métille

As implemented over the past twenty-six years, the Electronic Communications Privacy Act (ECPA), which regulates electronic surveillance by law enforcement agents, has become incomplete, confusing, and ineffective. In contrast, a new Swiss law (CrimPC) regulates law enforcement surveillance in a more comprehensive, uniform, and effective manner. This article compares the two approaches and argues that recent proposals to reform EPCA in a piecemeal fashion will not suffice. Instead, the Swiss CrimPC law presents a model for more fundamental reform of U.S. law.

This article is the first to analyze …

Hydropower: It's A Small World After All, Gina Warren

Gina Warren

Global warming is here. As exhibited by the recent droughts, heat waves, severe storms and floods, climate change is no longer a question for the future, but a problem for the present. Of the many ways to help combat climate change, this article discusses the use of the most abundant renewable energy source on the plant – water. While large-scale hydropower (think Hoover Dam) is unlikely to see increased development due to its negative impact on the environment, fish, and wildlife, small-scale hydropower (think a highly technologically-advanced water mill) is environmentally-friendly and would produce clean, renewable energy to benefit local …

The Law Of The Zebra, Andrea Matwyshyn

Andrea Matwyshyn

At the dawn of internet law, scholars and judged debated whether a “law of the horse” – a set of specific laws addressing technology problems – was ever needed. Time has demonstrated that, in some cases, the answer is yes. However, today courts are inherently confused regarding the trajectory for contract law in technology contexts: a technology-centric analysis is threatening to subvert traditional contract law and the future of entrepreneurship: circuit splits have emerged in what might be called an undesirable “law of the zebra.” Do contracts that involve technology indeed require exceptional contract rules? In particular, does the use …

Best Practices For Drafting University Technology Assignment Agreements After Filmtec, Stanford V. Roche, And Patent Reform, Parker Miles Tresemer

Parker Tresemer

Since the end of World War II, federally funded universities and private companies have been an integral part of continued American innovation and technological production. However, like most rational economic actors, universities and private companies are only willing to invest in federally funded technologies if they are guaranteed some sort of exclusive return on their investment. By granting federal contractors exclusive patent rights to their employee’s federally funded inventions, the Bayh-Dole Act provided the necessary incentives for private sector investment in federally funded technologies. However, case law subsequent to Bayh-Dole’s enactment has significantly undermined the system of incentives Congress intended …

Mixed Reality: How The Laws Of Virtual Worlds Govern Everyday Life, Joshua A.T. Fairfield

Joshua A.T. Fairfield

Just as the Internet linked human knowledge through the simple mechanism of the hyperlink, now reality itself is being hyperlinked, indexed, and augmented with virtual experiences. Imagine being able to check the background of your next date through your cell phone, or experience a hidden world of trolls and goblins while you are out strolling in the park. This is the exploding technology of Mixed Reality, which augments real places, people and things with rich virtual experiences. As virtual and real worlds converge, the law that governs virtual experiences will increasingly come to govern everyday life. The problem is that …

Addressing Access To Medicine: The Influence Of Competing Patent Perspectives, Cynthia M. Ho

Cynthia M Ho

Promoting access to affordable medicine for poor countries is considered important by a wide range of actors, including not only rich and poor countries, but also public health advocates, patent owners, and scholars. However, promoting access has been elusive. Public health advocates argue that access to medicine is increasingly difficult due to changes in domestic and international laws that limit access to unpatented and low-cost generic drugs by expanding the scope of patent rights. Patent owners and some countries deny these claims while simultaneously advocating for more expansive patent rights as necessary to promote innovation and development. This article addresses …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, K Van Tassel, R Goldman

Katharine A. Van Tassel

Consumers in the United States are being exposed to steadily increasing levels of novel and untested engineered nanoparticles as a result of their contact with everyday consumer products. Nanoparticles are very small particles that are engineered using innovative technologies to be 1 to 100 nanometers in size. Just how small is small? In comparison, a human hair is 80,000 nanometers wide. Nanoscale materials are increasingly being used in a wide variety of areas, including electronic, magnetic, medical imaging, drug delivery, catalytic, materials applications, and cosmetic products. According to the National Institute of Occupational Health, new nanotechnology consumer products are coming …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, K Van Tassel, R Goldman

Katharine A. Van Tassel

Consumers in the United States are being exposed to steadily increasing levels of novel and untested substances as a result of their contact with consumer products containing nanoparticles. Hundreds of consumer products are being marketed for human consumption, including food, dietary supplements, cosmetics and sunscreens. This expanding market ignores the growing scientific understanding that nanoparticles can create unintended human health and environmental risks. This Article discusses the public health, regulatory, legal and ethical issues raised by the developing appreciation of the health risks associated with nanotech products and is arranged as follows. After this Introduction, this Article describes the present …

Memory And Punishment, Orlando Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish is inextricably intertwined with how a crime is remembered — by the offender, by the sentencing authority, …

Avatar Experimentation: Human Subjects Research In Virtual Worlds, Joshua A.T. Fairfield

Joshua A.T. Fairfield

Researchers love virtual worlds. They are drawn to virtual worlds because of the opportunity to study real populations and real behavior in shared simulated environments. The growing number of virtual worlds and population growth within such worlds has led to a sizeable increase in the number of human subjects experiments taking place in such worlds. Virtual world users care deeply about their avatars, their virtual property, their privacy, their relationships, their community, and their accounts. People within virtual worlds act much as they would in the physical world, because the experience of the virtual world is "real" to them. The …

Putting The Gene Back In The Bottle: Why California Needs Stronger Protection Of Genetic Privacy In The Wake Of Affordable Dna Testing, Farid Zakaria

Farid Zakaria

In recent years, many “direct-to-consumer” genetic testing companies have started offering a DNA analysis service to the public. Based on the analysis of the DNA contained in saliva, these companies are able to inform the customer about his or her likelihood of having certain traits and of developing a number of diseases. Given the sensitive nature of this kind of information, this paper considers whether it is sufficiently protected under the current legal and regulatory framework. Specifically, the paper studies whether current federal, state, and common law that protects medical and private information also guarantees the privacy of genetic information. …

Out With A Bang: The Collapse Of Yucca Mountain Signals The Rise Of The New U.S. Cooperative Federalism Nuclear Reprocessing Model, Stefani C. Norrbin, Faye E. Jones

Faye E Jones

This Article argues that after the collapse of Yucca Mountain, the U.S. should move away from direct disposal by creating a new government backed, state-run corporation modeled after France’s Areva, to implement nuclear reprocessing in the U.S. This new model will help address the currently bankrupt nuclear waste system in the U.S. by using the money from the Nuclear Waste Fund that was collected for Yucca Mountain to provide financial support to states for nuclear reprocessing projects. Further, by working together, we can promote competition and innovation through state-run corporations backed by federal funding. In order to make the initial …

The Broadcasters’ Transition Date Roulette: Strategic Aspects Of The Dtv Transition, James E. Prieger, James Miller

James E. Prieger

The analog to digital “DTV transition” completed in June 2009 was a technological event unprecedented in scale in the broadcast television industry. The final analog cutoff for TV stations culminated more than ten years of complex regulatory decisions. Facing concerns that costs and revenue could change dramatically, stations chose when to transition in response to both market and regulatory forces. The history of broadcasting reveals a continual interplay between consumer demand, technological change, and regulation. This article describes the various forces that influenced the DTV transition, and empirically examines the stations’ decisions regarding when to switch. The economic and strategic …

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.

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

Memory And Punishment, Orlando Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered — by the offender, by the sentencing authority, …

Hidden Engines Of Destruction, Andrea Matwyshyn

Andrea Matwyshyn

This article explores whether a duty to warn should exist in the context of digital products. It argues in favor of creating a “reasonable expectation of code safety.” Section I explains the dominant ways that digital products can harm consumers through their code and not their content, focusing on functionality and information security harms. Section II reviews existing regulation of digital products and highlighted their focus on improving information parity and consumer control over digital product relationships. Section II then sets forth the scope of the duty to warn and protect from harms in real space owed by possessors of …

Responding, 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.

Plain Language Patents, Robin C. Feldman

Robin C Feldman

Law is a process of Bounded Adaptation. The law that exists at any given moment is constantly driven to adapt to changing circumstances within the framework of what has gone before. The boundaries of that framework are policed by the necessity of articulating an interpretation in a way that gains general acceptance. It is the need to effectively articulate a common logic that mitigates the distortion of personal perspective.

This process of Bounded Adaptation cannot proceed effectively without an adequately structured dialogue that will promote the flow of information and analysis. Nowhere is this dialogue more challenging than at the …

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.

Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, 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.

Real Taxation Of Virtual Commerce, Steven Chung

Steven Chung

In virtual worlds, people participate in fantasy adventures or socialize in a visually immersive online environment. Popular examples include World of Warcraft, Second Life, Entropia Universe and Ultima Online. As more people are reportedly earning real money through their virtual world activities, governments are looking into whether virtual world transactions are subject to real taxes, even if the participant does not convert his virtual income into cash. However, the application of U.S. tax law has led to unclear and sometimes conflicting interpretations.

This paper instead looks into the virtual world's economic environment to determine whether in-world transactions should be taxable …

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research (Aug. Draft), Michael J. Malinowski

Michael J. Malinowski

This article addresses the proliferation of race and ethnicity-based genetics research, which has become increasingly prevalent with the utilization of population genetics to make medical sense out of the map of the human genome. The article challenges the work of several law scholars with arguments based in bioethics, research pragmatism, and genetic science to propose that recognition of race and ethnicity is preferred in population genetics. The article concludes that proposals to stretch U.S. antidiscrimination jurisprudence to regulate away race and ethnicity in genetics research are misguided at best.