Law Commons^™

Court Of Appeals Of New York, People V. Taylor, Susan Persaud

Touro Law Review

No abstract provided.

“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.

County Court, Westchester County, People V. Gant, Albert V. Messina Jr.

Touro Law Review

No abstract provided.

Supreme Court, Bronx County, People V. Barnville, David Schoenhaar

Touro Law Review

No abstract provided.

Supreme Court, New York County, People V. Cespedes, Kathleen Egan

Touro Law Review

No abstract provided.

Supreme Court, Queens County, People V. Michaelides, Christin Harris

Touro Law Review

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 …

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

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 …

Supreme Court, New York County, People V. Smith, Jessica Miller

Touro Law Review

No abstract provided.

Appellate Division, Fourth Department, People V. Hall, Eric Pack

Touro Law Review

No abstract provided.

Court Of Appeals Of New York, People V. Burton, Diane Matero

Touro Law Review

No abstract provided.

Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff

Michigan Telecommunications & Technology Law Review

“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …

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 …

Taxing The War On Drugs: Tennessee's Unauthorized Substance Tax, Charles Traughber

Tennessee Journal of Law and Policy

In 2005, the Tennessee Legislature passed a law that granted the Tennessee Department of Revenue (hereinafter TDOR) the authority to levy a tax on unauthorized substances.1 This law requires drug dealers to pay a tax based on the type and amount of unauthorized substance they possess. Following payment of the tax, the TDOR issues the drug dealer a tax stamp that must be attached to the "unauthorized substances to indicate payment." A drug dealer arrested for possession of an unauthorized substance, absent an affixed tax stamp, faces not only criminal prosecution for the possession of the substance, but also an …

Shutting Down The Pharmacy On Wheels: Will Lance Armstrong’S Admission Impact The Practice Of Doping In Professional Cycling?, Kristina Fretwell

Pace Intellectual Property, Sports & Entertainment Law Forum

Lance Armstrong was one of the sport’s greatest heroes and his doping admission shook the American public to its core. Although professional cyclists are sanctioned for violating anti-doping rules on an almost regular basis, the investigation and lifetime ban of Lance Armstrong highlighted the serious problems facing the sport. Increased efforts to police drug use in cycling appear to be ineffective; however, as Armstrong’s situation may reveal, private law-suits have the potential to serve as a new and additional deterrent to cheating in the future.

The aftermath of Armstrong’s admission has led to bickering of the major regulatory agencies, leading …

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 …

The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman

Journal of Law and Health

The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …

Masking The Executioner And The Source Of Execution Drugs, Sandra Davidson, Michael Barajas

Saint Louis University Law Journal

No abstract provided.

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. …