Law Commons^™

What Is Federalism In Health Care For?, Nicole Huberfeld

Faculty Scholarship

The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …

Planning For Excellence: Insights From An International Review Of Regulators’ Strategic Plans, Adam M. Finkel, Daniel E. Walters, Angus Corbett

Faculty Scholarship

What constitutes regulatory excellence? Answering this question is an indispensable first step for any public regulatory agency that is measuring, striving towards, and, ultimately, achieving excellence. One useful way to answer this question would be to draw on the broader literature on regulatory design, enforcement, and management. But, perhaps a more authentic way would be to look at how regulators themselves define excellence. However, we actually know remarkably little about how the regulatory officials who are immersed in the task of regulation conceive of their own success.

In this Article, we investigate regulators’ definitions of regulatory excellence by drawing on …

Beyond Intermediary Liability: The Future Of Information Platforms - Workshop Report, Tiffany Li

Faculty Scholarship

On February 13, 2018, WIII hosted the workshop, “Beyond Intermediary Liability: The Future of Information Platforms.” Leading experts from industry, civil society, and academia convened at Yale Law School for a series of non-public, guided discussions. The roundtable of experts considered pressing questions related to intermediary liability and the rights, roles, and responsibilities of information platforms in society. Based on conversations from the workshop, WIII published a free, publicly available report detailing the most critical issues necessary for understanding the role of information platforms, such as Facebook and Google, in law and society today. The report highlights insights and questions …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Regulatory Cooperation In International Trade And Its Transformative Effects On Executive Power, Elizabeth Trujillo

Faculty Scholarship

As international trade receives the brunt of local discontent with globalization trends and recent changes by the Trump administration have put into question the viability of such trade arrangements moving forward, there has been a clear trend in using international trade fora for managing regulatory barriers on economic development. This paper will discuss this recent trend in international trade toward increased regulatory cooperation through the creation of formalized transnational regulatory bodies, such as the U.S.-EU Regulatory Cooperation Body that was being discussed in the TTIP negotiations and comparable ones in the Canadian-EU Trade Agreement as well as U.S.-Mexico and U.S.- …

Transparency's Ideological Drift, David E. Pozen

Faculty Scholarship

In the formative periods of American "open government" law, the idea of transparency was linked with progressive politics. Advocates of transparency understood themselves to be promoting values such as bureaucratic rationality, social justice, and trust in public institutions. Transparency was meant to make government stronger and more egalitarian. In the twenty-first century, transparency is doing different work. Although a wide range of actors appeal to transparency in a wide range of contexts, the dominant strain in the policy discourse emphasizes its capacity to check administrative abuse, enhance private choice, and reduce other forms of regulation. Transparency is meant to make …

Rise Of The Digital Regulator, Rory Van Loo

Faculty Scholarship

The administrative state is leveraging algorithms to influence individuals’ private decisions. Agencies have begun to write rules to shape for-profit websites such as Expedia and have launched their own online tools such as the Consumer Financial Protection Bureau’s mortgage calculator. These digital intermediaries aim to guide people toward better schools, healthier food, and more savings. But enthusiasm for this regulatory paradigm rests on two questionable assumptions. First, digital intermediaries effectively police consumer markets. Second, they require minimal government involvement. Instead, some for-profit online advisers such as travel websites have become what many mortgage brokers were before the 2008 financial crisis. …

Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson

Faculty Scholarship

In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Overreach And Innovation In Equality Regulation, Olatunde C.A. Johnson

Faculty Scholarship

At a time of heightened concern about agency overreach, this Article highlights a less appreciated development in agency equality regulation. Moving beyond traditional bureaucratic forms of regulation, civil rights agencies in recent years have experimented with new forms of regulation to advance inclusion. This new "inclusive regulation" can be described as more open ended, less coercive, and more reliant on rewards, collaboration, flexibility, and interactive assessment than traditional modes of civil rights regulation. This Article examines the power and limits of this new inclusive regulation and suggests a framework for increasing the efficacy of these new modes of regulation.

Debating Autonomous Weapon Systems, Their Ethics, And Their Regulation Under International Law, Kenneth Anderson, Matthew C. Waxman

Faculty Scholarship

An international public debate over the law and ethics of autonomous weapon systems (AWS) has been underway since 2012, with those urging legal regulation of AWS under existing principles and requirements of the international law of armed conflict, on the one side, in argument with opponents who favor, instead, a preemptive international treaty ban on all such weapons, on the other. This Chapter provides an introduction to this international debate, offering the main arguments on each side. These include disputes over defining an AWS, the morality and law of automated targeting and target selection by machine, and the interaction of …

Trade Agreements, Regulatory Sovereignty And Democratic Legitimacy, Bernard Hoekman, Charles F. Sabel

Faculty Scholarship

Governments increasingly are seeking to use bilateral and regional trade agreements to reduce the cost-increasing effects of differences in product market regulation. They also pursue regulatory cooperation independent of trade agreements. It is important to understand what is being done through bilateral or plurilateral mechanisms to address regulatory differences, and to identify what, if any, role trade agreements can play in supporting international regulatory cooperation. This paper reflects on experience to date in regulatory cooperation and the provisions of recent trade agreements involving advanced economies that have included regulatory cooperation. We argue for a re-thinking by trade officials of the …

Law And Economics Of Information, Tim Wu

Faculty Scholarship

Information is of enormous importance to contemporary economics, science, and technology. Since the 1970s, economists and legal scholars, relying on a simplified “public good” model of information, have constructed an impressively extensive body of scholarship devoted to the relationship between law and information. The public good model tends to justify law, such as the intellectual property laws or various forms of securities regulation that seek to incentivize the production of information or its broader dissemination. This chapter reviews the public choice model and identifies two recent trends. First, scholars have extended the public good model of information to an ever-increasing …

Accounting For Rising Corporate Profits: Intangibles Or Regulatory Rents?, James Bessen

Faculty Scholarship

Since 1980, US corporate valuations have risen relative to assets and operating margins have grown. The possibility of sustained economic rents has raised concerns about economic dynamism and inequality. But rising profits could come from political rents or, instead, from returns to investments in intangibles. Using new data on Federal regulation and data on lobbying, campaign spending, R&D, and organizational capital, this paper finds that both intangibles and political factors account for a substantial part of the increase in profits, but since 2000 political factors are more important. A difference-in-differences analysis finds that major expansions of regulation increase profits significantly.

Regulating Patent Assertions, Paul Gugliuzza

Faculty Scholarship

Recent years have seen a proliferation of statutes regulating and lawsuits challenging patent enforcement conduct. The Federal Circuit, however, has held that acts of patent enforcement are illegal only if there is clear and convincing evidence both that the patent holder’s infringement allegations were objectively baseless and that the patent holder knew or should have known its allegations were baseless. This chapter summarizes recent efforts by state governments and the federal government to control patent enforcement behavior, questions the broad immunity the Federal Circuit has conferred on patent holders, and seeks to improve pending federal legislation governing patent enforcement. In …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Regulating Employment-Based Anything, Brendan S. Maher

Faculty Scholarship

Benefit regulation has been called “the most consequential subject to which no one pays enough attention.” It exhausts judges, intimidates legislators, and scares off theorists. That need not be so. Reality is less complicated than advertised.

Governments often consider intervention if markets fail to make some socially desirable Good X — such as education, health care, home mortgages, or pensions, for example — sufficiently available. One obvious fix is for the government to provide the good itself. A less obvious intervention is for the government to regulate employment-based (EB) arrangements that provide Good X as a benefit to employees and …

Regulatory Entrepreneurship, Jordan M. Barry, Elizabeth Pollman

Faculty Scholarship

Numerous corporations, ranging from Airbnb to Tesla, and from DraftKings to Uber, have built huge businesses that reside in legal gray areas. Instead of taking the law as a given, these companies have become agents of legal change, focusing major parts of their business plans on changing the law. To achieve their political goals, these companies employ conventional lobbying techniques, but also more innovative tactics. In particular, some attempt to enter markets quickly, then grow too big to ban before regulators can respond. If regulators do take aim at them, they respond by mobilizing their users for political support. This …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

A Story Of Three Bank-Regulatory Legal Systems: Contract, Financial Management Regulation, And Fiduciary Law, Tamar Frankel

Faculty Scholarship

How should banks be regulated to avoid their failure? Banks must control the risks they take with depositors' money. If depositors lose their trust in their banks, and demand their money, the banks will fail. This article describes three legal bank regulatory systems: Contract with depositors (U.S.); a mix of contract and trust law, but going towards trust (Japan), and a full trust-fiduciary law regulating banks (Israel). The article concludes that bank regulation, which limits the banks' risks and conflicts of interest, helps create trustworthy banks that serve their country best.

Agenda-Setting In The Regulatory State: Theory And Evidence, Cary Coglianese, Daniel E. Walters

Faculty Scholarship

Government officials who run administrative agencies must make countless decisions every day about what issues and work to prioritize. These agenda-setting decisions hold enormous implications for the shape of law and public policy, but they have received remarkably little attention by either administrative law scholars or social scientists who study the bureaucracy. Existing research offers few insights about the institutions, norms, and inputs that shape and constrain agency discretion over their agendas or about the strategies that officials employ in choosing to elevate certain issues while putting others on the back burner. In this article, we advance the study of …

The Local Turn; Innovation And Diffusion In Civil Rights Law, Olatunde C.A. Johnson

Faculty Scholarship

Is the future of civil rights subnational? If one is looking for civil rights innovation, much of this innovation might be happening through legislation, regulatory frameworks, and policies adopted by state and local governments. In recent years, states and cities have adopted legislation banning discrimination in housing based on the source of an individual's income, regulating the consideration of arrest or conviction in employment decisions, and prohibiting discrimination in employment based on an applicant's credit history.

This deployment of subnational power is not new to civil rights. Many of the laws and regulatory frameworks that are now core to the …

God And Guns: The Free Exercise Of Religion Problems Of Regulating Guns In Churches And Other Houses Of Worship, John M.A. Dipippa

Faculty Scholarship

This Article demonstrates that the cases raising religious liberty challenges to state regulation of weapons in houses of worship reveal the persistent problems plaguing religious liberty cases. First, these cases illustrate the difficulties non-mainstream religious claims face. Courts may not understand the religious nature of the claim or they may devalue claims that do not seem “normal” or “reasonable.” This is compounded by how few religious liberty claimants, especially non-mainstream religions, win their cases. Second, the cases are part of the larger debate about how easy it should be to get judicially imposed religious exemptions from general and neutral laws. …

Helping Buyers Beware: The Need For Supervision Of Big Retail, Rory Van Loo

Faculty Scholarship

Since the financial crisis, consumer regulators have closely supervised sellers of credit cards and home mortgages to stamp out anticompetitive practices. Supervision programs give financial regulators ongoing access to sophisticated firms' internal data outside the litigation process. This often enables examiners to identify and correct harmful conduct more rapidly and effectively than would be possible using publicly available information and cumbersome legal tools.

Consumers spend four times more on retail goods than on financial products. The retail sector’s dominant firms — such as Amazon, Walmart, Unilever, and Kraft — employ large teams of quantitative experts armed with advanced information technologies, …

Harmonizing Third-Party Litigation Funding Regulation, Victoria Sahani

Faculty Scholarship

Third-party litigation funding is no longer a new phenomenon, but rather is a mainstay in global commerce and dispute resolution. Yet many observers still consider the third-party litigation funding industry as a “wild west” due to a lack of regulation in many countries. Some of the countries that have regulations suffer from a lack of uniformity and an array of conflicting laws at the sub-national level (i.e., the laws of states, provinces, territories, etc.). For example, the United States has a confusing patchwork of state laws on third-party litigation funding. This Article proposes harmonizing the regulatory framework for third-party litigation …

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Alice Corp. V. Cls Bank Int'l, Jordana Goodman

Faculty Scholarship

Congress has the power "to promote the Progress of Science and useful Arts."' Patent law subject matter eligibility under 35 U.S.C. section 101 creates a balance between incentivizing inventors to publicly disclose their knowledge and protecting the public from monopolies on ideas. Allowing inventors to monopolize the basic tools of scientific and technological work might "tend to impede innovation more than it would tend to promote it."² "Laws of nature, natural phenomena, and abstract ideas" constitute unpatentable subject matter under section 101.³ The section 101 inquiry serves as a threshold test to determine if the subject matter of …

Regulating Pot To Save The Polar Bear: Energy And Climate Impacts Of The Marijuana Industry, Gina S. Warren

Faculty Scholarship

It goes by many names: cannabis, marijuana, pot, chronic, grass, reefer, shwag, Mary Jane. Whatever the name, the trend is clear: the weed is legal but the herb ain’t green. Nearly half of all U.S. states have enacted—or have pending— legislation to legalize, decriminalize, or in some way permit the use and cultivation of marijuana. As a result, marijuana has become a significant topic of conversation in the U.S.— especially in the areas of social policy and criminal law. One conversation yet to reach fruition, however, is the industry’s projected impacts on energy demand and the climate. As the industry …