Law Commons^™

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

Justice At The Department Of Justice, William D. Corriher

William D Corriher

The paper discusses the continuing impact of two controversial actions by the Bush administration’s Department of Justice: the OLC’s enabling of torture and the policitization of federal prosecutions. The paper critiques several proposals for reform, including an independent Department of Justice, a “Truth Commission” to investigate the Bush administration, and new statutes governing the Department and its relationship with the President. The paper argues that an independent Department would likely be ruled unconstitutional under separation-of-powers principles. The paper concludes that the goal of any reform should be to ensure transparency in executive branch actions. While a “Truth Commission” can guarantee …

Guidelines As Guidelines: Lessons From The History Of Sentencing Reform, Rakesh Kilaru

Rakesh Kilaru

Over the last thirty years, sentencing guidelines have become an increasingly prominent feature of the American criminal justice system. Between the Supreme Court’s Apprendi-Blakely-Booker line of cases, dedicated law reviews like the Federal Sentencing Reporter, multitudinous other law review pieces, and Doug Berman’s famous sentencing blog, a great deal of ink has been spilled discussing the contours and future of guidelines reform. Most of this scholarship, however, falls in one of two camps. In one camp are scholars who chronicle the history of sentencing guidelines in particular states. In the other are scholars who discuss guidelines as a national phenomenon, …

Why Do Judges Read Statutes?, Alexander Volokh

Alexander Volokh

The standard view that "statutory interpretation matters" -- that different methods can "lead to" different results -- is hard to square with the standard rational-choice account of judicial decisionmaking. Indeed, under the standard model, it is not obvious why a judge should bother to even read the statute.

I show, within the rational-choice account, how the judge can benefit from reading the statute when the preferences of legislators are uncertain. Doing so shows the judge what policy the legislators agreed to in the past, which gives him clues as to legislators' preferences today. Moreover, different assumptions about how the legislature …

The Case For "Cramdown": Eliminating The Practical And Ideological Barriers To Pure Mortgage Modification, Peter J. Leo

Peter J Leo

This article was prepared for a seminar in Consumer Protection. The article makes the case that Congress should modify the Bankruptcy Code to allow for judicial modification of home mortgages on a bankrupt’s principal residence as a means of combating the foreclosure crisis. The article examines two different proposals originally published in the Minnesota Law Review and the Yale Journal on Regulation, examines some of the deficiencies in those proposals, and concludes that “cramdown” will be a more effective means of keeping consumers in their homes.

An Act For All Contexts: Incorporating The Pregnancy Discrimination Act Into Title Ix To Help Pregnant Students Gain And Retain Access To Education, Kendra H. Fershee

Kendra H Fershee

Few would agree that pregnancy discrimination is a tolerable by-product of a modern society. Yet there is at least one segment of society where pregnancy discrimination can thrive - federally funded schools. Even though Title IX was passed in 1972 to bar discrimination in school based on sex, it is quite possible for schools to discriminate based on pregnancy with little impunity. Worse, those who suffer the discrimination cannot sue for the harms they suffered in federal court, nor can they seek monetary redress, even if they were financially harmed by the discrimination.

The status of Supreme Court precedent, coupled …

A Critical Survey Of The Law, Ethics And Economics Of Attorney Contingent Fee Arrangements, Adam Shajnfeld

Adam Shajnfeld

This Article presents a critical survey of the law, ethics and economics of contingent fee arrangements for legal representation. First, it introduces the contingent fee, its history, and the various forms it takes. Second, it discusses and proposes changes in the use (or prohibition) of contingent fees in criminal, domestic relations and corporate matters. Third, it explores the concept of risk and its effect on legal fees, and analyzes various proposals that aim to reform risk-insensitive and uncompetitive pricing. Fourth, it examines agency problems in the attorney-client relationship that may be affected by fee arrangements, and makes suggestions for overcoming …

The Case For Overseas Article Iii Courts: The Blackwater Effect And Criminal Accountability In The Age Of Privatization, Alan F. Williams

Alan F. Williams

No abstract provided.

Honest Services And Dishonest Prosecutions, William D. Corriher

William D Corriher

The paper discusses Skilling v. United States, the recent Supreme Court case involving 18 U.S.C. § 1346, the federal statute prohibiting 'honest services" fraud. It begins by discussing the history of this form of fraud, from its origin in case law to its statutory form to the new definition articulated in Skilling. The background section goes on to discuss recent prosecutions under the statute, both corporate corruption cases and politically motivated prosecutions of public officials. The analysis section argues that it was inappropriate for the Skilling Court to redefine honest services fraud, because such a revision of a federal crime …

42 U.S.C. § 1983: A Legal Vehicle With No International Human Rights Treaty Passengers, Matthew J. Jowanna

Matthew J. Jowanna

How do international human rights treaties interact with the domestic civil rights law of the United States, and particularly 42 U.S.C. § 1983? How should international human rights treaties interact with the domestic civil rights law of the United States? “International law is part of our law, and must be ascertained and administered by the courts of justice of appropriate jurisdiction as often as questions of right depending upon it are duly presented for their determination.” Whether fully implemented in domestic law or not, the United States is obligated to respect the international treaties it ratifies. However, exactly how has …

Extraterritoriality And Its Discontents: Limiting The Reach Of U.S. Law, John H. Knox

John H Knox

How far do U.S. laws reach beyond U.S. borders? Many statutes do not specify their geographic scope, instead using general terms that have no inherent limit. In construing those laws, federal courts presume that legislation applies only within the territory of the United States. The apparent simplicity of the presumption against extraterritoriality masks difficult issues, which the Supreme Court has been unable to resolve. For example, the Court has issued contradictory decisions on whether U.S. territory includes U.S. bases in other countries, on how the presumption applies to foreign actions with domestic effects, and on what evidence is necessary to …

Just The Facts: Solving The Corporate Privilege Waiver Dilemma, Don R. Berthiaume

Don R Berthiaume

How can corporations provide “just the facts” — which are, in fact, not privileged — without waiving the attorney client privilege and work product protection? This article argues for an addition to the Federal Rules of Criminal Procedure based upon Rule 30(b)(6) of the Federal Rules of Civil Procedure, which allows civil litigants to issue a subpoena to an organization and cause them to “designate one or more officers, directors, or managing agents, or designate other persons who consent to testify on its behalf … about information known or reasonably available to the organization.”[6] Why should we look to Fed. …

Should "Substitute" Private Attorneys General Enforce Public Environmental Actions? Balancing The Costs And Benefits Of The Contingency-Fee Environmental Special Counselor Arrangement, Julie E. Steiner

Julie E. Steiner

There is developing phenomenon of quasi-privatized environmental enforcement occurring on behalf and in the name of governments by entrepreneurial attorneys who substitute in place of the public enforcers and derive professional payment from a contingent fee withdrawn from the public’s environmental damage award. This Article addresses the question of whether governments should permit private attorneys to handle these “substitute environmental special counsel” enforcement arrangements. In so doing, the Article weighs the arrangement’s costs and benefits from the standpoint of whether it maximizes the deterrence and restorative compensation goals of environmental enforcement.

Governments are often the only entities with standing to …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

Insiders Versus Outsiders: A Game-Theoretic Analysis Of The Puerto Rican Status Debate, F.E. Guerra-Pujol

F.E. Guerra-Pujol

In this paper, the author reviews some real-world examples of costly and protracted wars of attrition and describes the current debate over Puerto Rico’s constitutional status as a “legislative war of attrition.” In addition, the author presents a two-player as well as an n-player evolutionary war-ofattrition model and discusses this model’s possible application to the Puerto Rican status debate and other legislative, economic, and political stalemates.

Fannie Mae And Freddie Mac: Creatures Of Regulatory Privilege, David J. Reiss

David J Reiss

This book chapter addresses the appropriate role of Fannie Mae and Freddie Mac, the government-chartered, privately owned mortgage finance companies, in the United States housing finance sector. The federal government recently placed Fannie and Freddie in conservatorship. These two massive companies are profit-driven, but as government-sponsored enterprises they also have a government-mandated mission to provide liquidity and stability to the United States mortgage market and to achieve certain affordable housing goals. How the two companies should exit their conservatorship has implications that reach throughout the global financial markets and are of key importance to the future of American housing finance …

Problems And Reforms In Mortgage-Backed Securities: Handicapping The Credit Rating Agencies, Franz P. Hosp

Franz P Hosp V

Here we go again - another financial mess with credit rating agencies in the cross hairs. This is nothing new. Over the last four decades, credit rating agencies have been associated with several major financial disasters: the bankruptcy of Penn Central Transportation Company in 1970, the bankruptcy of Orange County in 1994, the Asian financial crisis in the late 1990's, the bankruptcy of Enron in 2001, and the bankruptcy of WorldCom in 2002.

Currently, the United States is suffering from an economic crisis precipitated largely by the deterioration of mortgage-backed securities. The process of securitizing mortgages is complex and involves …

A New Look At Section 504 And The Ada In Special Education Cases, Mark C. Weber

Mark C. Weber

School districts are finding fewer children eligible for services under the Individuals with Disabilities Education Act (IDEA). At the same time Congress has expanded the number of children who are protected by section 504 of the Rehabilitation Act and Title II of the Americans with Disabilities Act (ADA). These developments present the largely unexplored question of what obligations school districts owe children who have disabilities and are protected under section 504 and the ADA, but who are not eligible for services under IDEA. This article concludes that these children must be provided an education that meets their needs as adequately …

Unreasonable Accommodation And Due Hardship, Mark C. Weber

Mark C. Weber

This Article analyzes authoritative sources concerning the Americans with Disabilities Act accommodation requirement and concludes: (1) Reasonable accommodation and undue hardship are two sides of the same coin. The statutory duty is accommodation up to the limit of hardship, and reasonable accommodation should not be a separate hurdle for claimants to surmount apart from the undue hardship defense. There is no such thing as “unreasonable accommodation” or “due hardship.” (2) The duty to accommodate is a substantial obligation, one that may be expensive to satisfy, and one that is not subject to a cost-benefits balance, but rather a cost-resources balance; …

Making The States Full Partners In A National Climate Change Effort: A Necessary Element For Sustainable Economic Development, John Dernbach, Robert Mckinstry, Thomas Peterson

John C. Dernbach

This article explains why states and localities need to be full partners in a national climate change effort based on federal legislation or the existing Clean Air Act. A large share of reductions with the lowest cost and the greatest co-benefits (e.g., job creation, technology development, reduction of other pollutants) are in areas that a federal cap-and-trade program or other purely federal measures will not easily reach. These are also areas where the states have traditionally exercised their powers—including land use, building construction, transportation, and recycling. The economic recovery and expansion will require direct state and local management of climate …

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 …