Law Commons^™

“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness

Law Faculty Scholarly Articles

While no one would dispute that safety is a desirable objective, it may not always be an absolute priority. Rather, in some cases, other societal interests such as personal autonomy, consumer choice, product cost, and performance may trump legitimate safety goals. This is reflected in some of the doctrines and defenses that have evolved to protect the producers of unsafe products against tort liability. Some of these doctrines, such as those determining liability for the producers of optional safety equipment, inherently dangerous products, products with obvious hazards, and prescription drugs and medical devices, are part of the law of products …

Us Policies In Mexico Have Made Bad Situation Worse, Lauren Carasik

Media Presence

No abstract provided.

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

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 …

Ftc V. Lundbeck: Is Anything In Antitrust Obvious, Like, Ever?, Chris Sagers, Richard M. Brunell

Law Faculty Articles and Essays

In FTC v. Lundbeck, the Eighth Circuit affirmed a bench verdict finding a merger to monopoly, followed by a 1400% price increase, not only legal, but effectively not even subject to antitrust. The result followed from the district court's view that peculiarities in the market for hospital-administered drugs rendered it essentially immune from price competition. That being the case, the court found that even products very plainly substitutable on any traditional "functional interchangeability" analysis are not in the same "relevant market" for purposes of rules governing horizontal mergers. We think the court's analysis was incorrect for a number of …

S14rs Sgr No. 28 (Medical Amnesty, Drug-Related Emergencies), Jacob Boudreaux

Student Senate Enrolled Legislation

No abstract provided.

The Role Of Litigation In The Fight Against Prescription Drug Abuse, Richard C. Ausness

Law Faculty Scholarly Articles

Prescription drug abuse problems have prompted a number of responses by both drug users (and abusers) and by various federal and state government agencies.

Part I of this Article examines the impressive array of liability theories that individual litigants have relied upon in their lawsuits against Purdue. These theories include: negligence; strict products liability, including design defect and inadequate warning claims; breach of the implied warranty of merchantability; violation of state consumer protection statutes; negligent marketing; fraudulent misrepresentation; civil conspiracy; and "malicious conduct." Purdue, the company that developed OxyContin, has pursued an aggressive "no settlement" policy and has chosen to …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

The Influence Of The Andean Intellectual Property Regime On Access To Medicines In Latin America, Laurence R. Helfer, Karen J. Alter

Faculty Scholarship

This chapter is a contribution to "Balancing Wealth and Health: Global Administrative Law and the Battle over Intellectual Property and Access to Medicines in Latin America," Rochelle Dreyfuss & César Rodríguez-Garavito, eds. Part I of the chapter explains how the repeated interactions between the Andean Tribunal of Justice (ATJ) and domestic IP agencies in the Andean Community helped to build an effective IP rule of law and to solidify pro-consumer interpretations of regional patent and trademark rules. Part II documents how ATJ judges and agency officials enabled Andean governments to resist pressure from the United States and its pharmaceutical industry …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …