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Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget 2014 Seattle University School of Law

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 ...


For Every Wrong, A Remedy: A Narrow Interpretation Of The Locomotive Inspection Act's Preemptive Scope In Asbestos Cases, Andrew Malzahn 2014 Hamline University

For Every Wrong, A Remedy: A Narrow Interpretation Of The Locomotive Inspection Act's Preemptive Scope In Asbestos Cases, Andrew Malzahn

Hamline Law Review

abstract


Off-Road Torts: The Difficulties Of Representing A Client Injured Due To Defects In Vehicles Modified For Off-Road Use Or Injured Due To A Dangerous Condition Of The Land., Nicholas Morgan 2014 SelectedWorks

Off-Road Torts: The Difficulties Of Representing A Client Injured Due To Defects In Vehicles Modified For Off-Road Use Or Injured Due To A Dangerous Condition Of The Land., Nicholas Morgan

Nicholas Morgan

No abstract provided.


The Tort Entitlement To Physical Security As The Distributive Basis For Environmental, Health, And Safety Regulations, Mark A. Geistfeld 2014 NELLCO

The Tort Entitlement To Physical Security As The Distributive Basis For Environmental, Health, And Safety Regulations, Mark A. Geistfeld

New York University Law and Economics Working Papers

In a wide variety of contexts, individuals face a risk of being physically harmed by the conduct of others in the community. The extent to which the government protects individuals from such harmful behavior largely depends on the combined effect of administrative regulation, criminal law, and tort law. Unless these different departments are coordinated, the government cannot ensure that individuals are adequately secure from the cumulative threat of physical harm. What is adequate for this purpose depends on the underlying entitlement to physical security. What one has lost for purposes of legal analysis depends on what one what was entitled ...


The Tort Entitlement To Physical Security As The Distributive Basis For Environmental, Health, And Safety Regulations, Mark A. Geistfeld 2014 NELLCO

The Tort Entitlement To Physical Security As The Distributive Basis For Environmental, Health, And Safety Regulations, Mark A. Geistfeld

New York University Public Law and Legal Theory Working Papers

In a wide variety of contexts, individuals face a risk of being physically harmed by the conduct of others in the community. The extent to which the government protects individuals from such harmful behavior largely depends on the combined effect of administrative regulation, criminal law, and tort law. Unless these different departments are coordinated, the government cannot ensure that individuals are adequately secure from the cumulative threat of physical harm. What is adequate for this purpose depends on the underlying entitlement to physical security. What one has lost for purposes of legal analysis depends on what one what was entitled ...


State Farm 'With Teeth': Heightened Judicial Review In The Absence Of Executive Oversight, Catherine M. Sharkey 2014 NELLCO

State Farm 'With Teeth': Heightened Judicial Review In The Absence Of Executive Oversight, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

While courts and commentators have considered the information-forcing role of executive oversight and/or judicial review of agency action, the dynamic relationship between the two has yet to be considered. This Article presents a novel justification for heightened judicial scrutiny in the absence of meaningful executive oversight. Agency cost-benefit analyses and agency conflict preemption determinations — two realms rarely if ever considered together — are compared in terms of their underlying reliance on factual predicates and contrasted in terms of the existing framework for executive oversight and judicial review of agency determinations.

A heightened judicial review standard — what I term “State Farm ...


Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman 2014 Berkeley Law

Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman

Stephen D Sugarman

No abstract provided.


The Role Of Litigation In The Fight Against Prescription Drug Abuse, Richard C. Ausness 2014 University of Kentucky

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 ...


Benevolent Maleficence:How A Well-Intentioned Legislature And A Deferential Court Combined To Stunt The Development Of Massachusetts Product Liability Law, Philip E. Cleary 2014 University of Massachusetts School of Law

Benevolent Maleficence:How A Well-Intentioned Legislature And A Deferential Court Combined To Stunt The Development Of Massachusetts Product Liability Law, Philip E. Cleary

University of Massachusetts Law Review

Massachusetts product liability law is unusual. Unlike most states, Massachusetts does not recognize strict tort liability in the product area. Rather, "strict product liability" is limited to breaches of warranty under Article 2 of the Uniform Commercial Code. the Massachusetts Legislature amended Article 2 in several ways to provide a "strict liability" remedy that is, in the words of the Massachusetts Supreme Judicial Court, "congruent in nearly all respects with the principles" of strict tort liability. The court has construed the amendments to the UCC as precluding the adoption of strict tort liability in Massachusetts. In most ways, Massachusetts product ...


Tort Law In The Age Of Statutes, Mark A. Geistfeld 2014 NELLCO

Tort Law In The Age Of Statutes, Mark A. Geistfeld

New York University Public Law and Legal Theory Working Papers

The common law of torts is widely considered to be in conflict with the modern regulatory state. Tort law interacts with regulations and their enabling statutes in different ways that are fully addressed by the doctrines of negligence per se, the regulatory compliance defense, and statutory preemption. According to a substantial body of scholarship, these three statutorily related doctrines are a muddle, lacking any coherent theory that adequately accounts for the competing institutional concerns of the federal regulatory and state tort systems. The problem resides in a mistaken focus on statutory purpose. Due to the supremacy of legislative law, a ...


Ex-Post Right, Ex-Ante Wrong, Ariel Porat 2014 Notre Dame Law School

Ex-Post Right, Ex-Ante Wrong, Ariel Porat

Notre Dame Law Review

Should a doctor be held liable under negligence law for harmful treatment she administered to a patient, if the treatment should have been considered negligent at the time it was administered, but is now considered reasonable at the time of trial? Should a manufacturer be held liable for harm caused to a consumer from a product that is considered reasonable, and therefore nondefective, at the time of trial, but that should have been considered unreasonable, and therefore defective, at the time of its distribution? More generally put: Should the law impose liability for ex-post right but ex-ante wrong behaviors? The ...


The Technological And Business Evolution Of Machine Based Gambling In America, Darren Prum, Carlin McCrory 2014 SelectedWorks

The Technological And Business Evolution Of Machine Based Gambling In America, Darren Prum, Carlin Mccrory

Darren A. Prum

Machine Based Gambling has become a major source of revenue to many states across the country that need the money but face obstacles to raising taxes within their jurisdiction. The figures are startling with the Commonwealth of Pennsylvania’s cut at over $1.456 Billion in 2011, which exceed the next closest state by $500 million. In addition, there are more than twice as many slot machines available to the public than ATMs. The benefits of machine based gaming has allowed many governments to revitalized tourism locations, make some Native Americans economically self-sufficient, and save horse and dog race tracks ...


Corporate Social Responsibility In A Remedy-Seeking Society: A Public Choice Perspective, Donald J. Kochan 2014 Chapman University Dale E. Fowler School of Law

Corporate Social Responsibility In A Remedy-Seeking Society: A Public Choice Perspective, Donald J. Kochan

Donald J. Kochan

Written for the Chapman Law Review Symposium on “What Can Law & Economics Teach Us About the Corporate Social Responsibility Debate?,” this Article applies the lessons of public choice theory to examine corporate social responsibility. The Article adopts a broad definition of corporate social responsibility activism to include both (1) those efforts that seek to convince corporations to voluntarily take into account corporate social responsibility in their own decision-making, and (2) the efforts to alter the legal landscape and expand legal obligations of corporations beyond traditional notions of harm and duty so as to force corporations to invest in interests other ...


Against Categorical Preemption: Vaccines And The Compensation Piece Of The Preemption Puzzle, Catherine M. Sharkey 2013 NELLCO

Against Categorical Preemption: Vaccines And The Compensation Piece Of The Preemption Puzzle, Catherine M. Sharkey

New York University Law and Economics Working Papers

In tort preemption cases, when federal law ousts conflicting state tort law, two fundamental functional premises should hold true: (1) the federal standard of care is more than a minimal standard and (2) the state standard of tort liability has a significant regulatory effect (if not the regulatory purpose) by trading off risks and benefits to inhibit or to encourage risk-taking conduct that interferes with, or substantially alters, a federal regulatory scheme. The regulatory role of state tort law is front and center in this paradigm of preemption. But what about the compensatory role of tort law? Should there, in ...


The Future Of Classwide Punitive Damages, Catherine M. Sharkey 2013 NELLCO

The Future Of Classwide Punitive Damages, Catherine M. Sharkey

New York University Law and Economics Working Papers

Conventional wisdom holds that the punitive damages class action is susceptible not only to doctrinal restraints imposed on class actions but also to constitutional due process limitations placed on punitive damages. Thus, it would seem that the prospects for punitive damages classes are even grimmer than for class actions generally.

This conventional picture misunderstands the role of punitive damages and, in particular, the relationship between class actions and punitive damages. It either ignores or underestimates the distinctly societal element of punitive damages, which makes them especially conducive to aggregate treatment. Furthermore, punitive damages classes offer a solution to the constitutional ...


The Future Of Classwide Punitive Damages, Catherine M. Sharkey 2013 NELLCO

The Future Of Classwide Punitive Damages, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

Conventional wisdom holds that the punitive damages class action is susceptible not only to doctrinal restraints imposed on class actions but also to constitutional due process limitations placed on punitive damages. Thus, it would seem that the prospects for punitive damages classes are even grimmer than for class actions generally.

This conventional picture misunderstands the role of punitive damages and, in particular, the relationship between class actions and punitive damages. It either ignores or underestimates the distinctly societal element of punitive damages, which makes them especially conducive to aggregate treatment. Furthermore, punitive damages classes offer a solution to the constitutional ...


Against Categorical Preemption: Vaccines And The Compensation Piece Of The Preemption Puzzle, Catherine M. Sharkey 2013 NELLCO

Against Categorical Preemption: Vaccines And The Compensation Piece Of The Preemption Puzzle, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

In tort preemption cases, when federal law ousts conflicting state tort law, two fundamental functional premises should hold true: (1) the federal standard of care is more than a minimal standard and (2) the state standard of tort liability has a significant regulatory effect (if not the regulatory purpose) by trading off risks and benefits to inhibit or to encourage risk-taking conduct that interferes with, or substantially alters, a federal regulatory scheme. The regulatory role of state tort law is front and center in this paradigm of preemption. But what about the compensatory role of tort law? Should there, in ...


The Quest For The Next ‘Solvent Bystander’ In Asbestos Litigation: Will Texas Resume The Search?, Richard O. Faulk 2013 SelectedWorks

The Quest For The Next ‘Solvent Bystander’ In Asbestos Litigation: Will Texas Resume The Search?, Richard O. Faulk

Richard Faulk

Questions abound regarding the Bostic v. Georgia Pacific case. Is Texas preparing to resume the “endless search” for the next “solvent bystander?” Is the Texas Supreme Court considering a departure not only from Flores, but also from decades of settled Texas law regarding causation in tort cases? Hopefully, the memory of the disastrous and wasteful “cold war” of asbestos litigation will persist and rational common-law limits will not be sacrificed to resurrect a demonstrably abusive system.


Economic Analysis Of Medical Malpractice Liability And Its Reform, Jennifer Arlen 2013 NELLCO

Economic Analysis Of Medical Malpractice Liability And Its Reform, Jennifer Arlen

New York University Law and Economics Working Papers

This Chapter provides an economic analysis of medical error employing a model in which physicians who provide suboptimal medical care may have done so knowingly (as in the traditional model) or accidentally. Accidental medical error is a leading cause of medical negligence: many if not most physicians who provided suboptimal care did not know they were doing so but instead misdiagnosed the patient, unintentionally selected the wrong treatment or erred in treatment provision. Accordingly, in order to promote optimal health care markets, malpractice liability must be structured to both induce physicians to want to provide optimal treatments (when they are ...


Sue My Car Not Me: Products Liability And Accidents Involving Autonomous Vehicles, Jeffrey K. Gurney 2013 University of South Carolina

Sue My Car Not Me: Products Liability And Accidents Involving Autonomous Vehicles, Jeffrey K. Gurney

Jeffrey K Gurney

Autonomous vehicles will revolutionize society within the decade. These cars will cause accidents. Tort liability, however, is not ready for the introduction of autonomous vehicles, and, thus, liability will not be assessed to the party that is responsible for the accident. This Article addresses the liability of autonomous vehicle by examining products liability through the use of four scenarios: the Distracted Driver; the Diminished Capabilities Driver; the Disabled Driver; and the Attentive Driver.

Based on those scenarios, this Article argues that the autonomous technology manufacturer should be liable for accidents while the vehicle is in autonomous mode. This Article suggests ...


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