Law Commons^™

Evidence And Extrapolation: Mechanisms For Regulating Off-Label Uses Of Drugs And Devices, Ryan Abbott, Ian Ayres

Duke Law Journal

A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking. This "extrapolation" issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar …

The Duty To Maintain, Nadav Shoked

Duke Law Journal

Property is closely associated with freedom. Following the demise of the feudal property system, property ownership in Anglo-American law came to imply an individual's freedom to act as she pleases on her land. For their part, modern property theories—whether right-based, utilitarian, or relational—employ the normative value of freedom to justify ownership. Courts and scholars have always acknowledged the fact that this freedom of the owner cannot be absolute: an owner's freedom to do as she pleases on her land is often limited to protect other owners. However, the consensual assumption remains that an owner is not subject to affirmative duties. …

In Search Of Monsters Abroad: Serving Summonses On Foreign Organizations Under Rule 4 And Fifth Amendment Due Process, Kyle M. Druding

Duke Law Journal

Recently, federal prosecutors' increased interest in criminally charging foreign organizational defendants has revealed a "jurisdictional gap" in Rule 4 of the Federal Rules of Criminal Procedure. Rule 4, which has operated largely unchanged since its adoption in 1944, requires that a copy of a compulsory summons be served on an organizational defendant by mailing it either to the defendant's "last known address" in the relevant district or to its "principal place of business elsewhere in the United States." The courts have divided over how to confront jurisdictional challenges brought by certain foreign corporations—those without domestic principal places of business and …

Hipaa: Caught In The Cross Fire, Stephanie E. Pearl

Duke Law Journal

The Health Insurance Portability and Accountability Act (HIPAA) is nearly synonymous with patient privacy. In contrast, the National Instant Criminal Background Check System (NICS), a provision of the Gun Control Act of 1968, demands the disclosure of information about individuals, including mental-health information, that may prohibit their purchase of firearms.

These two statutes raise the following question: what if NICS requires or recommends the reporting of information protected by HIPAA? In the wake of recent gun violence by mentally disabled individuals, governmental and nongovernmental organizations have questioned whether HIPAA's privacy provisions have stultified national gun-control measures by prohibiting the reporting …

Journal Staff

Duke Law Journal

No abstract provided.

The Permit Power Revisited: The Theory And Practice Of Regulatory Permits In The Administrative State, Eric Biber, J.B. Ruhl

Duke Law Journal

Two decades ago, Professor Richard Epstein fired a shot at the administrative state that has gone largely unanswered in legal scholarship. His target was the "permit power," under which legislatures prohibit a specified activity by statute and delegate to administrative agencies the discretionary power to authorize the activity under terms the agency mandates in a regulatory permit. Accurately describing the permit power as an "enormous power in the state," Epstein bemoaned that it had "received scant attention in the academic literature." He sought to fill that gap. Centered on the premise that the permit power represents "a complete inversion of …

An Ex Ante Approach To Excessive State Debt, Vincent S. J. Buccola

Duke Law Journal

The recent recession has shone a very public spotlight on the perilous financial conditions of many American states. At the same time, it has renewed academic interest in the question of excessive state debt—its causes and possible cures. Scholars who see risk externalization as a primary driver of systematic overborrowing have proposed bankruptcy legislation for the states as one solution. Such advocates argue that a formal debt-adjustment mechanism could reduce the appeal of federal bailouts and thereby curtail the moral hazard leading to excessive debt. But given the states' unilateral power to set the terms of default, it is hard …

12 Confused Men: Using Flowchart Verdict Sheets To Mitigate Inconsistent Civil Verdicts, Jerry J. Fang

Duke Law Journal

The finality of jury verdicts reflects an implicit societal acceptance of the soundness of the jury's decision. Regardless, jurors are not infallible, and the questions they are often tasked with deciding are unfortunately neither obvious nor clear. The length of trial, complexity of subject matter, volume of factual background, and opaqueness of law can converge in a perfect storm that may confound even the most capable juror. Although the Federal Rules of Civil Procedure provide decision rules to resolve inconsistent verdicts, the current remedies authorized by Rule 49—notably, the resubmission of the verdict to the jury and the ordering of …

Causation’S Nuclear Future: Applying Proportional Liability To The Price-Anderson Act, William D. O’Connell

Duke Law Journal

For more than a quarter century, public discourse has pushed the nuclear-power industry in the direction of heavier regulation and greater scrutiny, effectively halting construction of new reactors. By focusing on contemporary fear of significant accidents, such discourse begs the question of what the nation's court system would actually do should a major nuclear incident cause radiation-induced cancers.

Congress's attempt to answer that question is the Price-Anderson Act, a broad statute addressing claims by the victims of a major nuclear accident. Lower courts interpreting the Act have repeatedly encountered a major stumbling block: it declares that judges must apply the …

Journal Staff, Journal Staff

Duke Law Journal

No abstract provided.

Choosing Not To Choose, Cass R. Sunstein

Duke Law Journal

Choice can be an extraordinary benefit or an immense burden. In some contexts, people choose not to choose, or would do so if they were asked. In part because of limitations of "bandwidth," and in part because of awareness of their own lack of information and potential biases, people sometimes want other people to choose for them. For example, many people prefer not to make choices about their health or retirement plans; they want to delegate those choices to a private or public institution that they trust (and may well be willing to pay a considerable amount to those who …

Windsor And Its Discontents: State Income Tax Implications For Same-Sex Couples, Haniya H. Mir

Duke Law Journal

In United States v. Windsor, the Supreme Court struck down section three of the federal Defense of Marriage Act. Shortly thereafter, the Internal Revenue Service issued a ruling under which all married same-sex couples will be treated as married for federal tax purposes. The IRS Ruling raised a host of state taxation issues for lawfully married same-sex taxpayers residing in nonrecognition states, given that nearly all states conform to the federal tax system to some degree so as to minimize taxpayers' calculations, record-keeping, and compliance burdens.

This Note explores the impact of the post-Windsor IRS Ruling on the …

A History Of Tax Regulation Prior To The Administrative Procedure Act, Bryan T. Camp

Duke Law Journal

The relationship of the Administrative Procedure Act (APA) to tax administration has been the subject of increasing scrutiny from scholars and courts. Some of this scrutiny has critiqued the long-held view of the Department of Treasury that tax regulations issued under the general grant of authority in I.R.C. § 7805(a) are interpretative regulations within the meaning of the APA. This Article reviews the almost 150–year history of tax administration before the enactment of the APA to show the origins and basis for this long-held view. The Article also argues that the application of the general terms of the APA to …

(Un)Appealing Deference To The Tax Court, Leandra Lederman

Duke Law Journal

The U.S. Tax Court (Tax Court), which hears the vast majority of litigated federal tax cases, occupies an unusual place in the federal government. It is a federal court located outside of the judicial branch, but its decisions are appealable to the federal courts of appeals. This odd structure, coupled with the court's history as an independent agency in the executive branch, can give rise to important questions, such as the standard of review that should apply to its decisions. In particular, should the courts of appeals treat Tax Court decisions the same as those of district courts in tax …

Reasoned Explanation And Irs Adjudication, Steve R. Johnson

Duke Law Journal

Under the Administrative Procedure Act (APA), an administrative action can be invalidated as arbitrary and capricious if the agency fails to sufficiently explain the reasons for its choices. This principle applies to agency adjudication as well as to agency rulemaking. How does this principle apply to IRS adjudications? Examining five paradigms of IRS decisionmaking, this Article first establishes that the IRS does engage in APA–style adjudication. The Article then examines tax-specific explanation requirements and asks whether a more robust explanation duty patterned on the APA should be imposed on IRS determinations. Based on a variety of legal and prudential considerations, …

Journal Staff

Duke Law Journal

No abstract provided.

Administering The Tax System We Have, Kristin E. Hickman

Duke Law Journal

Traditional perceptions of tax exceptionalism from administrativ–law doctrines and requirements have been predicated at least in part on the importance of the tax code's revenue–raising function. Yet, Congress increasingly relies on the Internal Revenue Service to administer government programs that have little to do with raising revenue and much more to do with distributing government benefits to the economically disadvantaged, subsidizing approved activities, and regulating outright certain economic sectors like nonprofits, pensions, and health care. As the attentions of the Treasury Department and Internal Revenue Service shift away from raising revenue and toward these other matters, the revenue—based justification for …

Taking Administrative Law To Tax, Amandeep S. Grewal

Duke Law Journal

No abstract provided.

A Case Study Of Legislation Vs. Regulation: Defining Political Campaign Intervention Under Federal Tax Law, Ellen P. Aprill

Duke Law Journal

The rules that should govern political campaign intervention by social welfare organizations exempt from taxation under § 501(c)(4) of the Internal Revenue Code have been the subject of recent controversy. Long before all the attention, a group of dedicated and experienced experts on the topic, under the auspices of two wellknown nonprofit groups, undertook the task of clarifying the rules regarding tax-exempt political activity. In light of the issues becoming national news, the group, known as the Bright Lines Project, also converted the regulatory proposal into legislative language. These two versions of the same rules—as a set of regulations and …

Maybe Just A Little Bit Special, After All?, Lawrence Zelenak

Duke Law Journal

The attitude—common among tax professionals—that tax is special (mostly because of its supposedly unique complexity), and that special legal rules should apply in the tax context, has been described and excoriated by scholars as "tax exceptionalism" or "tax myopia." The Supreme Court dealt tax exceptionalism a grievous blow in its 2011 opinion in Mayo Foundation for Medical Education & Research v. United States, in which it held that the Chevron standard for determining the validity of regulations applied in tax just as it applied in other fields. One commentator gleefully celebrated Mayo as the death knell of tax exceptionalism, …

Nonsense And The Freedom Of Speech: What Meaning Means For The First Amendment, Joseph Blocher

Duke Law Journal

A surprising amount of everyday expression is, strictly speaking, nonsense. But courts and scholars have done little to consider whether or why such meaningless speech falls within "the freedom of speech." If, as many suggest, meaning is what separates speech from sound and expression from conduct, then the constitutional case for nonsense is complicated. And because nonsense is widespread, the case is also important—artists like Lewis Carroll and Jackson Pollock are not the only putative "speakers" who should be concerned about the outcome.

This Article is the first to explore thoroughly the relationship between nonsense and the freedom of speech; …

The Fall And Rise Of The Exit Consent , Keegan S. Drake

Duke Law Journal

Bond issuers wanting to restructure their distressed debt often propose an exchange offer, in which the issuer persuades its bondholders to swap their present holdings for new bonds capable of being honored. To guard against nonparticipating bondholders, issuers may pair their exchange offers with an exit consent. A use of a bond's modification clause, an exit consent is a technique by which bondholders participating in the exchange also vote to impair the distressed bonds.

Use of the exit consent raises a contract question about the duty of good faith and fair dealing. For a quarter of a century, exit consents …

Journal Staff

Duke Law Journal

No abstract provided.

Combating Privatization: Modifying The Veterans Administration Fiduciary Program To Protect Incompetent Veterans, Whitney Bosworth Blazek

Duke Law Journal

Created to supervise the distribution of Veterans Administration benefits, the Veterans Benefit Administration Fiduciary Program was designed to help thousands of incompetent veterans handle their finances. Rather than directly managing each veteran's funds, the Fiduciary Program employs a privatization model whereby a private individual or institution is appointed to manage a veteran's assets. The Fiduciary Program then monitors these fiduciaries to ensure the veteran's funds are properly expended.

This Note argues that in practice this privatization model is seriously flawed and that it exposes some of the most vulnerable portions of the veteran population's funds to misuse. In support of …

Licensed To Kill: A Defense Of Vicarious Liability Under The Endangered Species Act , Devon Lea Damiano

Duke Law Journal

The Endangered Species Act (ESA) makes it illegal to "take" an endangered and threatened species by killing, harming, or harassing the animal. Although the classic example of a take is an individual poacher shooting an endangered species, these protected species are also harmed by larger–scale policies and programs. In several court cases, local and state governments have been held vicariously liable for the take of endangered species when their policies or actions caused third parties to commit a take.

The vicarious liability theory, as applied to the ESA, is controversial and has been criticized by numerous scholars. This Note argues …

Lex Majoris Partis: How The Senate Can End The Filibuster On Any Day By Simple Majority Rule , Akhil Reed Amar

Duke Law Journal

No abstract provided.

The Sometimes “Craven Watchdog”: The Disparate Criminal-Civil Application Of The Presumption Against Extraterritoriality, S. Nathan Williams

Duke Law Journal

Increasingly, courts must decide whether U.S. law applies extraterritorially. Courts largely resolve questions of extraterritorial scope using tools of statutory construction. Of these tools, the presumption against extraterritoriality has been ascendant. However, this presumption is subject to two divergent lines of cases: Morrison v. National Australia Bank Ltd. affirmed the strict operation of the presumption in civil cases, but United States v. Bowman continues to govern the presumption's looser role in criminal cases, thereby creating a doctrinal asymmetry. This Note furthers the argument that courts should reconcile Morrison and Bowman, by laying out three arguments for why an expansive …

Out Of Practice: The Twenty-First-Century Legal Profession, Dana A. Remus

Duke Law Journal

Lawyering has changed dramatically in the past century, but scholarly and regulatory models have failed to keep pace. Because these models focus exclusively on the "practice of law" as defined by the profession, they ignore many types of work that today's lawyers perform and many sources of ethical tension they encounter. To address these shortcomings, I examine significant twentieth- and twenty-first-century social dynamics that are fundamentally altering contemporary lawyers' work by broadening and blurring the boundary between law and business. Within the resulting boundary zone, a growing number of lawyers occupy roles for which legal training is valuable but licensure …

Journal Staff

Duke Law Journal

No abstract provided.

Sword Or Shield? Setting Limits On Slusa’S Ever-Growing Reach, Cecilia A. Glass

Duke Law Journal

Concerned by the overwhelming presence of vexatious federal securities-fraud class actions, Congress passed the Private Securities Litigation Reform Act of 1995 to increase the procedural burden plaintiffs would face in filing these nonmeritorious suits. Instead of being deterred, plaintiffs simply brought their suits in state court. Congress responded with the Securities Litigation Uniform Standards Act of 1998 (SLUSA), making federal court the exclusive venue for securities-fraud class actions. However, Congress expressly saved from SLUSA's reach claims that were traditionally brought in state court under corporate law through the Delaware carve-out.

Though this exemption was meant to protect the historic dual …