Law Commons^™

Mandated Ethical Hacking—A Repackaged Solution, Corinne Moini

Law Student Publications

Hacking to prove a point or to expose technological vulnerabilities has been around since the 1960s, but it has been labeled and packaged differently as “white hacking” or “ethical hacking.” This article suggests that smart toy manufacturers, such as Mattel and VTech, should be subject to required vulnerability testing which utilizes ethical hacking under the Consumer Product Safety Improvement Act (“CPSIA”). More specifically, this article proposes to amend the Toy Safety Standard, ASTMF- 963-11, to include smart toys connected to the internet. The CPSIA and Consumer Product Safety Commission (“CPSC”) impose safety testing on all toys intended for use by …

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

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 …

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. …

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

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 …

Comment On "Error And Regulatory Risk In Financial Institution Regulation", Keith N. Hylton

Faculty Scholarship

I agree with just about everything Jonathan Macey (2017) says in his symposium contribution. His claim that bureaucratic tendencies toward regularity—specifically, treating like cases alike—generate errors in categorization seems appropriate to me. His explanations of the pathologies in financial regulation should fall in the category of essential or required reading for anyone who chooses to write on the topic. Where I differ from Macey is in the choice of framework, or perspective from which to view the pathologies. Whereas Macey adopts an “error cost” framework, which is clearly appropriate for this symposium, I would build explicitly on a “public choice” …

The Securities Black Market: Dark Pool Trading And The Need For A More Expansive Regulation Ats-N, Brian P. Baxter

Vanderbilt Law Review

Procedural law in the United States seeks to achieve three interrelated goals in our system of litigation: efficient processes that achieve "substantive justice" and deter wrongdoing, accurate outcomes, and meaningful access to the courts. For years, however, procedural debate, particularly in the context of due process rights in class actions, has been redirected toward more conceptual questions about the nature of legal claims-are they more appropriately conceptualized as individual property or as collective goods? At stake is the extent to which relevant procedures will protect the right of individual claimants to exercise control over their claims. Those with individualistic conceptions …

The Human Side Of Public-Private Partnerships: From New Deal Regulation To Administrative Law Management, Alfred C. Aman, Joseph C. Dugan

Articles by Maurer Faculty

During the New Deal era, Congress created a then-unprecedented program of economic and regulatory reforms, establishing independent agencies, and empowering them to shape and enforce pragmatic industrial policies. Twenty-first century regulation looks strikingly different from the New Deal vision. While New Deal agencies continue to perform some regulatory functions, market approaches have replaced many traditional command-and-control formulations, with private entities stepping in to perform tasks historically reserved to government.

Though government-by-contract is becoming the new normal, neither the Administrative Procedure Act ("APA") nor many of its state equivalents provide adequate guidance to ensure that individual rights are protected and democratic …

Benchmark Regulation, Gina-Gail S. Fletcher

Articles by Maurer Faculty

Benchmarks are metrics that are deeply embedded in the financial markets. They are essential to the efficient functioning of the markets and are used in a wide variety of ways-from pricing oil to setting interest rates for consumer lending to valuing complex financial instruments. In recent years, benchmarks have also been at the epicenter of numerous, multi-year market manipulation scandals. Oil traders, for example, deliberately execute trades to drive benchmarks lower artificially, allowing the traders to capitalize on the manipulated benchmarks. This ensures that later trades relying on the benchmarks will be more profitable than they otherwise would have been. …

Climate Regulation Of The Electricity Industry: A Comparative View From Australia, Great Britain, South Korea, And The United States, Lincoln L. Davies, Penelope Crossley, Peter Connor, Siwon Park, Shelby Shaw-Hughes

South Carolina Journal of International Law and Business

No abstract provided.

Constraining Monitors, Veronica Root

Journal Articles

Monitors oversee remediation efforts at dozens, if not hundreds, of institutions that are guilty of misconduct. The remediation efforts that the monitors of today engage in are, in many instances, quite similar to activities that were once subject to formal court oversight. But as the importance and power of monitors has increased, the court’s oversight of monitors and the agreements that most often result in monitorships has, at best, been severely diminished and, at worst, vanished altogether.

The lack of regulation governing monitors is well documented; yet, the academic literature on monitorships to date has largely taken the state of …

Climate Regulation Of The Electricity Industry: A Comparative View From Australia, Great Britain, South Korea, And The United States, Lincoln L. Davies, Penelope Crossley, Peter Connor, Siwon Park, Shelby Shaw-Hughes

Utah Law Faculty Scholarship

Climate regulation of the electricity sector is one of the most important growing — and rapidly changing — areas of law and policy today. This is both because of the critical role that electricity plays in modern society, acting as economic lifeblood, and because of electricity’s part in driving climate change, accounting for more greenhouse gas (GHG) emissions globally than any other activity. This article provides an introduction to different methods of regulating climate emissions from the electricity sector. It does so through detailed, comparative accounts of climate regulation of electricity in four different jurisdictions: Australia, Great Britain, South Korea, …

A Legal Study On The Internal Control System For Direction Of Legislation In Korea, Sungbum Kwon

Maurer Theses and Dissertations

The concept of internal control began in accounting professional groups, gradually expanded to the administrative control and the risk management from accounting control, and became an important area that cannot be excluded from the operation of the public companies in the U.S.

When the Enron scandal struck the credibility of the stock market in the U.S. in 2001, the authorities implemented reformative measures including the SOX enactment to protect investors. Although there has been a controversy over this legislation since the enactment of the SOX, it appears that the U.S. capital market has been restoring confidence with the efforts of …

Dead Or Alive? The Law, Policy, And Market Effects Of Legislation On Unclaimed Life Insurance Benefits, James M. Carson, Robert E. Hoyt, Tim R. Samples

Notre Dame Journal of Law, Ethics & Public Policy

A wave of multi-state audits on the insurance industry’s use of the Social Security Administration’s Death Master File (DMF) stirred national controversy over the status of unclaimed life insurance proceeds. Multi-state investigations uncovered “asymmetric” use of the DMF among many large insurance companies. Accusations of unethical behavior led to numerous settlement agreements between state regulators and insurers. Payouts and fines stemming from these settlements already number in the billions of dollars. Legislative responses are also underway. Some states have adopted—and others are considering—legislation requiring life insurers to search the DMF to identify and pay (or eascheat) unclaimed death benefits. Currently, …

Penn Central Take Two, Christopher Serkin

Vanderbilt Law School Faculty Publications

Penn Central v. New York City is the most important regulatory takings case of all time. There, the Supreme Court upheld the historic preservation of Grand Central Terminal in part because the City offset the burden of the landmarking with a valuable new property interest—a transferable development right (TDR)—that could be sold to neighboring property. Extraordinarily, 1.2 million square feet of those very same TDRs, still unused for over forty years, are the subject of newly resolved takings litigation. According to the complaint, the TDRs that saved Grand Central were themselves taken by the government, which allegedly wiped out their …

Disruptive Platforms, Margot Kaminski

Publications

No abstract provided.

Conceptualizing Cryptolaw, Carla L. Reyes

Faculty Journal Articles and Book Chapters

Sweden transfers its real property recording system to the blockchain, a software protocol that enables public, cryptographically secure transaction verification without reliance upon a trusted third party. Dubai plans to issue blockchain-based government documents. The United States Department of Health and Human Services investigates blockchain-based systems for managing health data. Illinois explores blockchain-based applications for use in the Illinois government. News of governments and public-private partnerships developing blockchain-based legal applications increasingly splash across the headlines; however the law-makers using blockchain and other Distributed Ledger Technology (DLT) systems to implement legal processes do not systematically consider the broader implications of their …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman

Faculty Journal Articles and Book Chapters

The conventional wisdom is that an executive agency’s scope of action and power depends on how easy it is to reverse agency decisions in court. If non-deferential judges provide industry with prompt review of agency decisions, the agency’s power is limited. And if courts are unlikely to second-guess the agency’s interpretations, then private actors have little choice but to comply. But in recent years, agencies have begun to rely on a new weapon in this struggle with courts and industry — the power of proposed rules to achieve regulatory outcomes. When regulations will affect long-term capital investments, companies must set …

Dictation And Delegation In Securities Regulation, Usha Rodrigues

Scholarly Works

When Congress undertakes major financial reform, either it dictates the precise contours of the law itself or it delegates the bulk of the rulemaking to an administrative agency. This choice has critical consequences. Making the law self-executing in federal legislation is swift, not subject to administrative tinkering, and less vulnerable than rulemaking to judicial second-guessing. Agency action is, in contrast, deliberate, subject to ongoing bureaucratic fiddling and more vulnerable than statutes to judicial challenge.

This Article offers the first empirical analysis of the extent of congressional delegation in securities law from 1970 to the present day, examining nine pieces of …

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 …

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 …

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.

Comments On Omb's Interim Guidance Implementing Section 2 Of Executive Order 13,771 Reducing Regulation And Controlling Regulatory Costs, Jeffrey Lubbers

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Teaching Health Law From A Social-Ecological Perspective, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

I started teaching health law relatively recently-in the fall of 2010, just after the Affordable Care Act ("ACA") was enacted, but before much of it had been implemented. This timing has been a blessing because I started with a fresh slate rather than adding the ACA on top of a previously developed course. It has also been a curse, but ultimately I appreciate that I started teaching the course at a time when the ACA was under constant threat. The ever-evolving nature of health law means that health law teachers must always bear in mind a goal that applies to …

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 …

Government Rule Compliance, Safety, And The Influence Of Regulation On Railroad Trainmen, Carlos Mendoza, Phd

Walden Dissertations and Doctoral Studies

Operational testing of railroad trainmen on federal government safety rules is a daily occurrence on every railroad in the United States. This constant testing and resulting discipline distracts trainmen from the task at hand, causing a loss of focus which could lead to injury or accidents. Using the social construction framework, this research sought to gain an understanding of trainmen's perception on how operational testing impacts their workplace safety, as well as how they perceive the U.S. federal government influences regulation and discipline. This phenomenological study investigated a segment of railroad employees, the trainmen, because they are operationally tested more …

The European Company, Pieter Sanders

Georgia Journal of International & Comparative Law

No abstract provided.

Regulating Secrecy, W. Nicholson Price Ii

Articles

Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …

Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets

Journal of Food Law & Policy

We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …