Law Commons^™

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Stephanie Bair

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

A Model Regime Of Privacy Protection (Version 2.0), Daniel J. Solove, Chris Jay Hoofnagle

Chris Jay Hoofnagle

This version incorporates and responds to the many comments that we received to Version 1.1, which we released on March 10, 2005.

Privacy protection in the United States has often been criticized, but critics have too infrequently suggested specific proposals for reform. Recently, there has been significant legislative interest at both the federal and state levels in addressing the privacy of personal information. This was sparked when ChoicePoint, one of the largest data brokers in the United States with records on almost every adult American citizen, sold data on about 145,000 people to fraudulent businesses set up by identity thieves. …

A Model Regime Of Privacy Protection (Version 1.1), Daniel J. Solove, Chris Jay Hoofnagle

Chris Jay Hoofnagle

Privacy protection in the United States has often been criticized, but critics have too infrequently suggested specific proposals for reform. Recently, there has been significant legislative interest at both the federal and state levels in addressing the privacy of personal information. This was sparked when ChoicePoint, one of the largest data brokers in the United States with records on almost every adult American citizen, sold data on about 145,000 people to fraudulent businesses set up by identity thieves.

In the aftermath of the ChoicePoint debacle, both of us have been asked by Congressional legislative staffers, state legislative policymakers, journalists, academics, …

Why The Unfccc And Cbd Should Refrain From Regulating Solar Climate Engineering

Jesse Reynolds

Beyond Westphalia: Competitive Legalization In Emerging Transnational Regulatory Systems, Errol E. Meidinger

Errol Meidinger

Published as Chapter 7 in Law and Legalization in Transnational Relations, Christian Brütsch & Dirk Lehmkuhl, eds.

This paper analyzes several emerging transnational regulatory systems that engage, but are not centered on state legal systems. Driven primarily by civil society organizations, the new regulatory systems use conventional technical standard setting and certification techniques to establish market-leveraged, social and environmental regulatory programs. These programs resemble state regulatory programs in many important respects, and are increasingly legalized. Individual sectors generally have multiple regulatory programs that compete with, but also mimic and reinforce each other. While forestry is the most developed example, similar …

The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.This paper is an effort to assist courts and …

Activating Actavis, Aaron Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In Federal Trade Commission v. Actavis, Inc., the Supreme Court provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. The Court came down strongly in favor of an antitrust solution to the problem, concluding that “an antitrust action is likely to prove more feasible administratively than the Eleventh Circuit believed.” At the same time, Justice Breyer’s majority opinion acknowledged that the Court did not answer every relevant question. The opinion closed by “leav[ing] to the lower courts the structuring of the present rule-of-reason antitrust litigation.”This article is an effort to help courts and counsel …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

Scaling "Local": The Implications Of Greenhouse Gas Regulation In San Bernardino County, Hari M. Osofsky

Hari Osofsky

This Essay analyzes local climate regulation in San Bernardino County as a window into the complexities of defining a local scale in an interconnected world. In so doing, it aims to contribute to the Symposium's broader dialogue about "Territory Without Boundaries" and the Panel's more specific discussion of "Urban Territory in a Global World." As a purely territorial matter, U.S. cities and counties differ substantially in their sizes, the quantity and physical characteristics of their land, the size and density of their populations, and the needs of their citizens. Structurally, these localities remain administrative subunits of states, but they also …

Earthquakes In The Oilpatch: The Regulatory And Legal Issues Arising Out Of Oil And Gas Operation Induced Seismicity, Monika Ehrman

Monika U. Ehrman

Pornography As Pollution, John C. Nagle

John Copeland Nagle

Pornography is often compared to pollution. But little effort has been made to consider what it means to describe pornography as a pollution problem, even as many legal scholars have concluded that the law has failed to control internet pornography. Opponents of pornography maintain passionate convictions about how sexually-explicit materials harm both those who are exposed to them and the broader cultural environment. Viewers of pornography may generally hold less fervent beliefs, but champions of free speech and of a free internet object to anti-pornography regulations with strong convictions of their own. The challenge is how to address the widespread …

A Taxonomy Of Lawyer Regulation, Russell G. Pearce, Noel Semple, Renee Newman Knake

Noel Semple

What explains the dramatic contrast between legal services regulation in the United States and anglophone Canada, on one hand, and England/Wales and Australia, on the other? In order to help explain these divergent regulatory choices, and to further comparative analysis, this Essay proposes a taxonomy of theories of legal services regulation drawn from these common-law jurisdictions. Although most jurisdictions employ a combination of approaches, as well as some hybrid methods, the Essay identifies the two dominant perspectives: (1) the professionalist-independent framework, predominate in anglophone North America, and (2) the consumerist-competitive framework found in the common law jurisdictions of Northern Europe …

Private Enforcement, Stephen B. Burbank, Sean Farhang, Herbert Kritzer

Sean Farhang

Our aim in this Article is to advance understanding of private enforcement of statutory and administrative law in the United States and to raise questions that will be useful to those who are concerned with regulatory design in other countries. To that end, we briefly discuss aspects of American culture, history, and political institutions that reasonably can be thought to have contributed to the growth and subsequent development of private enforcement. We also set forth key elements of the general legal landscape in which decisions about private enforcement are made, aspects of which should be central to the choice of …

The Hidden Costs Of Free Goods: Implications For Antitrust Enforcement, Michal S. Gal, Daniel L. Rubinfeld

Daniel L. Rubinfeld

Today a growing number of goods and services are provided in the marketplace free of charge; indeed, free or the appearance of free, have become part of our ecosystem. More often than not, free goods and services provide real benefits to consumers and are clearly pro-competitive. Yet free goods may also create significant costs. We show that despite the fact that the consumer does not pay a direct price, there are indirect prices that reflect the opportunity cost associated with the consumption of free goods. These indirect costs can be overt or covert, in the same market in which the …

Border Crossings: Nafta, Regulatory Restructuring, And The Politics Of Place, Ruth Buchanan

Ruth Buchanan

Professor Buchanan begins her paper by questioning whether recent economic and political shifts towards notions of "globalization" (e.g., the NAFTA) have failed to consider the politics or economics of change in particular places. Her prime example of a "place" where integration is illogically forced against a background of differentiation is the U.S.-Mexico border region. Through the scope of a "regulatory complex" (a complex of legal, institutional, regulatory, and social orderings), she departs from the common view of the NAFTA as a productive tool of North American integration, and instead views the NAFTA as exacerbating "differences between localities, industries, and labor …

Demand Response And Market Power, Bruce R. Huber

Bruce R Huber

In her article, Bypassing Federalism and the Administrative Law of Negawatts, Sharon Jacobs educates her readers about the concept of demand response, and then describes its propagation in recent years while making the broader argument that the Federal Energy Regulatory Commission (“FERC”) — the federal government’s principal energy regulator — has engaged in a strategy of “bypassing federalism” that may entail more costs than benefits. Professor Jacobs is right to call attention to demand response and to FERC’s approach to matters of jurisdictional doubt. While I share many of her concerns about boundary lines in a federal system, I argue …

Lawyers Without Borders, Catherine A. Rogers

Catherine Rogers

Professional regulation of attorneys is still attempting to catch up with the burgeoning international legal profession, which until recently has been wholly unregulated. The primary effort has been through revisions to Model Rule 8.5 to extend the reach of the Rule to international cases and professional activities in foreign countries. Because Rule 8.5 was drafted for domestic multi-jurisdiction practice, however, it is based on assumptions about territoriality and the historical relationship between the jurisdiction of tribunals and the licensing of attorneys that are simply inapposite in international settings. As a result, applying Rule 8.5 to international tribunals and international advocacy …

The Environmental Deficit: Applying Lessons From The Economic Recession, Christine A. Klein

Christine A. Klein

In 2007, the nation entered its greatest financial downturn since the Great Depression of the 1930s. What followed was a period of national introspection. Although prescriptions for financial rescue varied widely in the details, a surprisingly broad consensus emerged as to the underlying pathology of the crisis. This Article explores three principal contributing factors and the lessons associated with each that make up this pathology. These factors include: rejecting rules through deregulation, trivializing risk through overly optimistic analyses, and overconsumption supported by reckless borrowing and lending practices. The powerful lessons from this pathology, considered by a stunned nation in the …

Land Use Regulation (2d Ed.), Stewart E. Sterk, Eduardo M. Penalver, Sara C. Bronin

Sara C. Bronin

Mariguana Para Fines Lúdicos, Alejandro Faya Rodriguez

Alejandro Faya Rodriguez

No abstract provided.

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

O. Carter Snead

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

A Conceptual Framework For The Regulation Of Cryptocurrencies, Omri Y. Marian

Omri Y Marian

This Essay proposes a conceptual framework for the regulation of transactions involving cryptocurrencies. Cryptocurrencies offer tremendous opportunities for innovation and development but are also uniquely suited to facilitate illicit behavior. The regulatory framework suggested herein is intended to support (or at least not impair) cryptocurrencies’ innovative potential. At the same time, it aims to disrupt cryptocurrencies’ criminal utility. To achieve these purposes, this Essay proposes a regulatory framework that imposes costs on the characteristics of cryptocurrencies that make them especially useful for criminal behavior (in particular, anonymity) but does not impose costs on characteristics that are at the core of …

Underground Environmental Regulations: Regulations Imposed As Mitigation Measures Under Ceqa Violate The California Administrative Procedure Act, Jonathan Wood

Jonathan Wood

What happens when an agency adopts a regulation under the California Environmental Quality Act as mitigation for a program’s environmental impact, without complying with the procedural requirements of the California Administrative Procedure Act? According to a recent California Court of Appeal decision – Center for Biological Diversity v. Department of Fish and Wildlife – these mitigation measures, which this article refers to as underground environmental regulations, are invalid. This article defends that interpretation and addresses its consequences for agencies and the regulated public. Although these additional procedural protections benefit regulated parties in a variety of ways, they can also burden …

Jurisdictional Standards (And Rules), Adam I. Muchmore

Adam I. Muchmore

This Article uses the jurisprudential dichotomy between two opposing types of legal requirements — “rules” and “standards” — to examine extraterritorial regulation by the United States. It argues that there is natural push toward standards in extraterritorial regulation because numerous institutional actors either see standards as the best option in extraterritorial regulation or accept standards as a second-best option when their first choice (a rule favorable to their interests or their worldview) is not feasible. The Article explores several reasons for this push toward standards, including: statutory text, statutory interpretation theories, the nonbinary nature of the domestic/foreign characterization, the tendency …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Adam I. Muchmore

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

Take It To The Limit: The Illegal Regulation Prohibiting The Take Of Any Threatened Species Under The Endangered Species Act, Jonathan Wood

Jonathan Wood

The Endangered Species Act forbids the “take” – any activity that adversely affects – any member of an endangered species, but only endangered species. The statute also provides for the listing of threatened species, i.e. species that may become endangered, but protects them only by requiring agencies to consider the impacts of their projects on them. Shortly after the statute was adopted, the U.S. Fish and Wildlife Service and National Marine Fisheries Service reversed Congress’ policy choice by adopting a regulation that forbids the take of any threatened species. The regulation is not authorized by the Endangered Species Act, but …

Reforma Anticorrupción, Alejandro Faya Rodriguez

Alejandro Faya Rodriguez

No abstract provided.

Heterodox Challenges To Consumption-Oriented Models Of Legislation, Luigi Russi, John Haskell

Luigi Russi

Consumption-oriented models of governance dominate the contemporary global legal architecture. The financial crisis beginning in 2008, however, poses fundamental questions about the future viability of these approaches to economics and law. This paper attempts to first, evaluate consumptionÕs salient historical development and themes from the post- World War II era to more recent legislative innovation, and second, introduce seven heterodox vignettes that challenge the hegemony of consumption in legislative policy. The paper concludes with some brief reflections upon potential opportunities and limitations of these heterodox traditions within future scholarship and policy addressing the interplay of law and consumption in global …