Law Commons^™

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 …

Law Enforcement And Criminal Law Decisions, Erwin Chemerinsky

Erwin Chemerinsky

No abstract provided.

Cocaine, Race, And Equal Protection, David Sklansky

David A Sklansky

No abstract provided.

Drugs On Tap: Managing Pharmaceuticals In Our Nation’S Waters, Gabriel Eckstein

Gabriel Eckstein

Pharmaceuticals in the environment and public water supplies are believed to have serious impacts on human and environmental health. Current research suggests that exposure to certain drugs and their residues may result in a variety of adverse human health effects. Other studies more conclusively show that even minute concentrations of pharmaceuticals in the environment can have detrimental effects on aquatic and terrestrial species. Unfortunately, the cost of removing these pernicious substances is out of the financial reach of most municipalities and wastewater and drinking water treatment operators.Despite the concerns, little effort has been made to develop broad management, mitigatory, or …

Sentencing Pregnant Drug Addicts: Why The Child Endangerment Enhancement Is Not Appropriate, Monica Carusello

Monica B Carusello

No abstract provided.

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Avoiding The Subject: The Opium War, Opium-Markets, And The Exclusion Of Chinese Laborers In The United States, Canada, And Mexico, Olivia L. Blessing

Olivia L Blessing

The 19th century saw significant increases in the number of Chinese immigrants entering North America, most significantly on the west coast of the United States. Already facing increasing divide amongst the American population over the issue of the Opium Wars and the resulting Opium-addiction amongst the Chinese, the United States found itself now confronting the problem in the form of immigrant workers. Although the Opium Wars and the issue of the Chinese Opium Dens were highly disputed outside the courts, the State and Federal courts surprisingly avoided discussing the topic in their legislative discussions surrounding the Chinese Exclusion Act of …

Delivering Our Promise To Black Males, Edward Earl Bell

Dr. Edward E. Bell

It will take a village---and then some!

Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale

Frank A. Pasquale

Normative analysis of cognition-enhancing drugs frequently weighs the liberty interests of drug users against egalitarian commitments to a "level playing field." Yet those who would refuse to engage in neuroenhancement may well find their liberty to do so limited in a society where such drugs are widespread. To the extent that unvarnished emotional responses are world-disclosive, neurocosmetic practices also threaten to provide a form of faulty data to their users. This essay examines underappreciated liberty-based and epistemic rationales for regulating cognition-enhancing drugs.

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

Todd Grabarsky

The legal status of medical marijuana in the United States is something of a paradox. On one hand, federal government has placed a ban on the drug with no exceptions. On the other hand, over one-third of the states have that legalizes the cultivation, distribution, and consumption of the drug for medical purposes. As such, the usage of medical marijuana is an activity that is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented nebulous zone of legality in …

Oversight Of Marketing Relationships Between Physicians And The Drug And Device Industry: A Comparative Study, Timothy Stoltzfus Jost

Timothy S. Jost

Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This articlef ocuses on one particulara spect of these relationships--paymentsm ade by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond …

The Newest Jim Crow And The Incarceration Of Black Males, Edward Earl Bell

Dr. Edward E. Bell

Black males are in jail. Are "we" to blame? The New Jim Crow is alive.

La Bodega De La Familia: Supporting Parolees' Reintegration Within A Family Context, Jeanne Flavin, David Rosenthal

Jeanne M Flavin

This essay discusses how Family Justice and La Bodega de la Familia respond to the diverse challenges of reintegration post incarceration. It also discusses the benefits of a model of judicial supervision that recognizes individuals' social locations within their families and communities. With the goal of producing more effective and humane prisoner reintegration, especially in the context of drug offenses, the Authors recommend family case management. They additionally encourage parole and criminal justice practice to shift its focus from the individual parolee to families and their strengths.

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …

Pushing Drugs Or Pushing The Envelope: The Prosecution Of Doctors In Connection With Over-Prescribing Of Opium-Based Drugs, Deborah Hellman

Deborah Hellman

No abstract provided.

The Physician Payments Sunshine Act And The Problem Of Pharmaceutical Companies' Influence Over Prescribing Physicians, Andrew L. Younkins

Andrew L Younkins

Recently, concerns over physicians' conflict of interest have increased as the details of some doctors' consulting relationships with pharmaceutical companies surface. In an effort to cleanse medicine of egregiously conflicted doctors, Senator Grassley proposed of the Physician Payments Sunshine Act ("PPSA") in the Senate last year. The Act mandates reporting of uncommonly large payments by drug companies to doctors, but does not confront the panoply of more subtle yet more powerful methods the drug industry uses to influence prescriber behavior. This paper argues that industry-sponsored CME, small gifts, drug samples and drug detailers unconsciously influence physician prescribing behavior, and that …

Race In The War On Drugs: The Social Consequences Of Presidential Rhetoric, Jeff L. Yates, Andrew Whitford

Jeff L Yates

One of the president’s main leadership tools for influencing the direction of American legal policy is public rhetoric. Numerous studies have examined the president’s use of the “bully pulpit” to lead policy by influencing Congress or public opinion, or by changing the behavior of public agencies. We argue that the president can use rhetoric to change the behavior of public agencies and that this can have important social consequences. We focus on the disproportionate impact of presidential rhetoric on different “target populations” in the context of the War on Drugs. Specifically, we observe that presidential rhetoric had a greater impact …

No Rational Basis: The Pragmatic Case For Marijuana Law Reform, Eric Blumenson

Eric Blumenson

This article presents a critique of marijuana prohibition and suggests some alternative regulatory approaches that would be more productive and consonant with justice. Part I relies on a forty-year empirical record to demonstrate that (1) reliance on a law enforcement approach has aggravated rather than mitigated the risks involved with marijuana use, and (2) criminalization, which results in the arrest of more than 700,000 Americans annually for possession of any amount of marijuana, is an inhumane and destructive response to an act that almost 100 million Americans have committed. Part II assesses the relative merits of several alternative reform policies, …

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Vicki W Girard

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Ariel Katz

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …

Rethink The "War On Drugs", John J. Donohue

John Donohue

Crime is an issue that often seeps into Presidential elections in one form or another. Indeed, the Bush Administration has rolled back or undermined the two primary crime‐fighting initiatives of the Clinton Administration by allowing the 1994 federal ban on assault weapons to lapse, and by eliminating Clinton’s COPS program, which put tens of thousands of new police on the streets of American cities. Gun control is largely a dead letter, since the NRA has shown that it has the power to keep any type of gun in the hands of anyone who wants them, as well as the power …