Law Commons^™

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 …

Ironic Simplicity: Why Shaken Baby Syndrome Misdiagnoses Should Result In Automatic Reimbursement For The Wrongly Accused, Jay Simmons

Seattle University Law Review

Shaken baby syndrome (SBS)’s shortcomings include the debatable science behind SBS theory and diagnosis—the questioning of which has grown more vociferous—and the arguably biased, discriminatory treatment of the accused. Professor Deborah Tuerkheimer notes that the evolving SBS skepticism and contentious debate has resulted in "chaos" in many SBS adjudications and within the medical and biomechanical fields, with the same SBS proponents and opponents continually crusading for and clashing over their beliefs. The issues surrounding the medical and biomechanical components of SBS diagnoses have been repeatedly examined and discussed, and are not the focus of this Note. This Note recounts those …

Sacred Cows, Holy Wars: Exploring The Limits Of Law In The Regulation Of Raw Milk And Kosher Meat, Kenneth Lasson

All Faculty Scholarship

In a free society law and religion seldom coincide comfortably, tending instead to reflect the inherent tension that often resides between the two. This is nowhere more apparent than in America, where the underlying principle upon which the first freedom enunciated by the Constitution's Bill of Rights is based ‒ the separation of church and state – is conceptually at odds with the pragmatic compromises that may be reached. But our adherence to the primacy of individual rights and civil liberties ‒ that any activity must be permitted if it is not imposed upon others without their consent, and if …

Protecting Whistleblower Protections In The Dodd-Frank Act, Samuel C. Leifer

Michigan Law Review

In 2008, the United States fell into its worst economic recession in over seventy years. In response, Congress enacted the near-comprehensive Dodd–Frank Wall Street Reform and Consumer Protection Act. Section 922 of Dodd–Frank, in particular, includes specific provisions designed to incentivize and protect corporate whistleblowers. These provisions demonstrated Congress’s belief that a comprehensive and robust whistleblower protection scheme was essential to preventing many of the abuses that caused the financial crisis. Unfortunately, this section’s inconsistent language has produced conflicting decisions within the federal judiciary. In accordance with the Securities and Exchange Commission (“SEC”)’s own reading of Section 922, several district …

Target, Negligence, Chips, And Chickens, Jesse D. Gossett

Jesse D Gossett

SHOPPING ON BLACK FRIDAY. It’s almost as American as baseball and apple pie. But during the 2013 holiday season, over forty million U.S. citizens experienced what is increasingly becoming a uniquely American problem: face-to-face (“FTF”) credit card fraud. This online article briefly explores the problems of data hacking and credit card fraud. It then looks at how European countries have largely avoided the problem and what American consumers can do to minimize the problem here.

The Evolution And Decline Of The Effective-Vindication Doctrine In U.S. Arbitration Law, Okezie Chukwumerije

Pepperdine Dispute Resolution Law Journal

This article offers information on the history, significance and role of the effective-vindication doctrine in U.S. arbitration law in promoting access to justice. It analyzes the significance of broad policy implications regarding the interpretation of the Federal Arbitration Act (FAA) by the Court facilitating the arbitration of commercial disputes and protecting the statutory rights of consumers in the context of the U.S. Supreme Court's decision in Green Tree Financial Corp. v. Randolph.

Loose Teeth In European Union Consumer Protection Policy: The Injunction Directive And The Mass Default Scenario, David J. Schwartz

Georgia Journal of International & Comparative Law

No abstract provided.

High Technology, Consumer Privacy, And U.S. National Security : Hearing Before The Subcomm. On Commerce, Manufacturing, And Trade Of The H. Comm. On Energy And Commerce, 113th Cong., September 17, 2014 (Remarks By Professor Laura K. Donohue, Geo. U. L. Center), Laura K. Donohue

Testimony Before Congress

Documents released over the past year detailing the National Security Agency’s telephony metadata collection program and interception of international content under the Foreign Intelligence Surveillance Act (FISA) directly implicated U.S. high technology companies in government surveillance. The result was an immediate, and detrimental, impact on U.S. firms, the economy, and U.S. national security.

The first Snowden documents, printed June 5, 2013, revealed that the U.S. government had served orders on Verizon, directing the company to turn over telephony metadata under Section 215 of the USA PATRIOT Act. The following day, The Guardian published classified slides detailing how the NSA had …

Get The Lead Out: A New Approach For Regulating The U.S. Toy Market In A Globalized World, Gabriel Allen

Georgia Journal of International & Comparative Law

No abstract provided.

Sue And Settle: Demonizing The Environmental Citizen Suit, Stephen M. Johnson

Seattle University Law Review

In the spring of 2013, industry groups and states began a concerted lobbying effort to oppose citizen enforcement of the federal environmental laws. The United States Chamber of Commerce and lobbyists for states created a catch-phrase—“sue and settle”—to demonize citizen enforcement and the federal government’s practice of settling lawsuits it is destined to lose in court. The Chamber alleged that the federal government, by settling lawsuits brought by citizens groups rather than defending them in court, was colluding with those non-governmental organizations and excluding other affected parties to reallocate the agencies’ priorities and obligations. Federal environmental laws establish a central …

Inevitable Imbalance: Why Ftc V. Actavis Was Inadequate To Solve The Reverse Payment Settlement Problem And Proposing A New Amendment To The Hatch-Waxman Act, Rachel A. Lewis

Seattle University Law Review

The law regarding reverse payment settlements is anything but settled. Reverse payment settlements are settlements that occur during a patent infringement litigation in which a pharmaceutical patent holder pays a generic drug producer to not infringe on the pharmaceutical patent. Despite the recent decision by the United States Supreme Court in FTC v. Actavis, Inc., there are still unanswered questions about how the “full rule of reason” analysis will be applied to reverse payment. This Comment argues that despite the outcome in Actavis, the complex regulatory framework of the Hatch–Waxman Act will create repeated conflicts between antitrust law and patent …

Opening Schumer’S Box: The Empirical Foundations Of Modern Consumer Finance Disclosure Law, Hosea H. Harvey

University of Michigan Journal of Law Reform

This Article explores the fundamental failure of Congress’ twenty-five-year quest to utilize disclosure as the primary tool to both regulate credit card issuers and educate consumers. From inception until present, reforms to this disclosure regime, even when premised on judgment and decision-making behavioralism, were nomothetic in orientation and ignored clear differences in population behavior and the heterogeniety of consumers. Current law prohibits credit card issuers from acquiring consumer socio-demographic data and prevents issuers and regulators from using market and policy experimentation to enhance disclosure’s efficacy. To explain why this regime was structured this way and why it must change, this …

A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven

Florida A & M University Law Review

The historical art of seed saving ensured farmers would have enough quality seeds for the following season. Traditional and indigenous farmers mastered seed saving techniques, saving the healthiest and strongest seeds to ensure preservation of seed diversity and adequate crop yields. To provide adequate protection and meet maximum sustainability for all interested parties, it is essential that laws governing the soybean industry consider the soybean as a stakeholder.

The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan

West Virginia Law Review

No abstract provided.

The Troubled State Of America's Nursing Homes, Albert Moran

Albert Moran

Even the most cursory search of news coverage involving nursing homes reveals that horror stories are not difficult to come by. Although the grisly details of each individual horror story vary, most of them share the same general story line—through some combination of gross negligence and profound systemic failure, elderly citizens can experience disturbing conditions in nursing homes that result in suffering and sometimes death. While egregious stories make local news headlines every so often and prompt a brief firestorm of public criticism, the everyday reality of nursing homes is much less sensationalized, and arguably even more sobering. Statistics indicate …

Complexity And Simplicity In Law: A Review Essay (Cass R. Sunstein, Simpler: The Future Of Government (2003)), David M. Driesen

David M Driesen

This essay discusses Cass Sunstein’s book, Simpler: The Future of Government, in order to advance our understanding of the concepts of complex and simple law. Many writers identify complexity with uncertainty and high cost. This essay argues that complexity bears no fixed relationship to costs or benefits. It also shows that complexity’s relationship to uncertainty is so ambiguous that it is profitable to treat complexity and uncertainty as separate concepts. It develops useful separate concepts of legal and compliance complexity that will aid efforts to simplify law, like the one Sunstein claims to have embarked upon. It also argues that …

Can Consumers Bring State Claims For Furnisher Errors On Their Credit Reports, Catherine Bourque

Legislation and Policy Brief

In an increasingly digital world, it can often feel like numbers define us. Whether your social security number, your phone number, or your credit score, the cold truth is that your identity is often boiled down to a single number. In the financial world, your credit score traditionally defines your eligibility for credit and the cost of credit, but the uses of credit scores have expanded to include premiums for insurance, employment eligibility, and other non-financial determinations. Particularly in tough financial times, small fluctuations in credit scores can have large impacts on consumers’ access to affordable credit.

As furnishers and …

Sacred Cows, Holy Wars: Exploring The Limits Of Law In The Regulation Of Raw Milk And Kosher Meat, Kenneth Lasson

Kenneth Lasson

SACRED COWS, HOLY WARS Exploring the Limits of Law in the Regulation of Raw Milk and Kosher Meat By Kenneth Lasson Abstract In a free society law and religion seldom coincide comfortably, tending instead to reflect the inherent tension that often resides between the two. This is nowhere more apparent than in America, where the underlying principle upon which the first freedom enunciated by the Constitution’s Bill of Rights is based ‒ the separation of church and state – is conceptually at odds with the pragmatic compromises that may be reached. But our adherence to the primacy of individual rights …

The Missing Link: U.S. Regulation Of Consumer Cosmetic Products To Protect Human Health And The Environment, Valerie J. Watnick

Pace Environmental Law Review

This article explores these lax regulatory efforts and their connection to risk assessment, and proposes changes to our current toxics regulatory paradigm. Part I of this article explores our current regulatory approach for consumer cosmetics. Part II discusses the specific and dire concerns regarding chemicals that are suspected carcinogens and those suspected of disrupting the human endocrine system. The article argues in Part III that because the framework for our current regulation of consumer cosmetic products is not designed to be protective of human health, our regulatory paradigm must shift dramatically in the future if this is to become our …

Daños Punitivos En Mexico. Renacimiento De La Responsabilidad Civil, Jorge E. De Hoyos Walther

Jorge E De Hoyos Walther

La Suprema Corte de Justicia reconoce la existencia de los daños punitivos en México. Esta resolución tendrá un impacto importante en las demandas por responsabilidad civil y en los litigios transfronterizos.

The Law And Economics Of Microfinance, Katherine Helen Mary Hunt

Katherine Helen Mary Hunt

Financial inclusion may be jargon which appeals to international donors and academics, but the strategic implementation in developing countries is often based on international du jour priorities, such as microfinance. The topic of microfinance is highly debated in the academic literature, although little empirical work has been published. Further, no literature to date has considered microfinance from a law and economics perspective. This paper seeks to contribute to the gap in the literature by considering how microfinance has evolved to address the credit market failure, and how microfinance regulation should be designed to promote long term financial inclusion via financially …

The Future Of The Private Label Securities Market, David J. Reiss

David J Reiss

The PLS market, like all markets, cycles from greed to fear, from boom to bust. The mortgage market is still in the fear part of the cycle and recent government interventions in it have, undoubtedly, added to that fear. In recent days, there has been a lot of industry pushback against the government’s approach, including threats to pull out of various sectors. But the government should not chart its course based on today’s news reports. Rather, it should identify fundamentals and stick to them. In particular, its regulatory approach should reflect an attempt to align incentives of market actors with …

O Dano Psíquico Nas Relações Civis E De Consumo, Lucas Abreu Barroso, Eini Rovena Dias

Lucas Abreu Barroso

Socio-economic practices and hyper-consumption stimulate the creation of new types of damage. The demand for full protection of the human person increases proportionally in civil and consumer relationships. But the role that falls to tort law does not find - in the legal dogmatics - adequate tools to face such a challenge. The scenario is even worse with respect to non-material damages. With their identification as moral damages, the recognition of other categories of damages in Brazilian law such as psychic damages, based on the protection of psychophysical integrity of the victim, is prevented.

Comentarios Al Proyecto Sobre Justicia En Las Relaciones De Consumo, Gabriel Martinez Medrano

Gabriel Martinez Medrano

Comentario al Proyecto del P.E. Argentino sobre Justicia para las relaciones de Consumo (menor cuantía). Visión positiva del proyecto con algunas indicaciones prácticas.

Warning: A Post-Sale Duty To Warn Targets Small Manufacturers, Jill Wieber Lens

Utah Law Review

The majority of states now obligate manufacturers to warn about dangers of their products that are discoverable after the sale. Commentators and courts have been hesitant about this obligation because of the potential burden it puts on manufacturers — the costs of identifying users and warning them of the danger. The consensus is that only a factually dependent post-sale duty to warn should exist, obligating manufacturers to warn only if a reasonable manufacturer would do so. A reasonable manufacturer, of course, would warn only if the danger to be warned of justifies the costs of the warning.

This Article is …

The Price Of Crisis: Eminent Domain, Local Governments, And The Value Of Underwater Mortgages, Raymond H. Brescia, Nicholas Martin

Raymond H Brescia

In response to the lingering fallout from the Financial Crisis of 2008, local governments have begun to explore whether it is wise and legal to use the power of eminent domain to seize distressed home mortgages. This Article attempts to situate this approach to such mortgages within the larger economic, legal and policy context and asks three key questions. First, are local governments appropriate actors to address the lingering problem of underwater mortgages? Second, assuming they are appropriate actors to address this problem, how should localities and, if necessary, courts, value underwater mortgages in the context of condemnation proceedings: i.e., …

Armed, Unarmed Or Harmed By Knowledge? A Comment On The Fha's Housing Counseling Pilot Program, David J. Reiss

David J Reiss

The FHA has requested input on its Homeowners Armed with Knowledge (HAWK) for New Homebuyers pilot program. This comment letter argues that housing counseling is not a proven solution to the problem it is meant to solve, excessive defaults by FHA borrowers. HAWK is a traditional housing counseling program but the scholarly literature casts into doubt the efficacy of such programs. It would be better to take time to research which counseling strategies, if any, are proven to be effective. This is true for the FHA but also for other government agencies, such as the Consumer Financial Protection Bureau, that …

Seeking Solutions To Financial History Discrimination, Lea Krivinskas Shepard

Lea Krivinskas Shepard

Employers’ use of credit reports to evaluate prospective job applicants has generated considerable scrutiny in the popular press and academic literature, but few proposals for reform. This Article explores three possible ways of reducing the risk of financial history discrimination in the employment setting.

First, imposing inquiry limits on employers’ use of credit reports, a policy recently adopted or under consideration in the majority of states, is unlikely to be effective, since states’ inquiry limits are currently narrowly drafted and therefore advance few anti-discriminatory objectives. In addition, inquiry limits cannot prevent self-interested individuals from voluntarily revealing their credit histories and …

Too Complex To Perceive? Drafting Cash Distribution Waterfalls Directly As Code To Reduce Complexity And Legal Risk In Structured Finance, Master Limited Partnership, And Private Equity Transactions, Ralph C. Mayrell

Pace Law Review

This Article proposes that complex structured finance transactions involving sophisticated investors should adopt an analogous solution to the home construction agreements’ strategy of contracting by reference to blueprints. First, dealmakers should, preferably by choice, place as much of their waterfall distribution specification and related inputs as possible into automated, programmatic representations that will be used to make the actual distribution. In many cases, these agreements already have programmatic representations, so this change should pose relatively few practical challenges logistically. Second, they should, like their counterparts in construction contracts, define the terms of those waterfalls by reference to their functional representations. …

Durbin Amendment To The Dodd Frank Act: Two Caps Are Better Than One For Debit Card Interchange Fees, Maureen Kane

Florida State University Law Review

No abstract provided.