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Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, 2018 Brigham Young University Law School

Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process

BYU Law Review

Congress created the premarket approval process (PMA) to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the Food and Drug Administration (FDA) to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome ...


The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel 2018 Concordia University School of Law, Boise

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on ...


Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel 2018 Concordia University School of Law, Boise

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a ...


Blacklisted: The Constitutionality Of The Federal System For Publishing Reports Of "Bad" Doctors In The National Practitioner Data Bank, Katharine Van Tassel 2018 Concordia University School of Law, Boise

Blacklisted: The Constitutionality Of The Federal System For Publishing Reports Of "Bad" Doctors In The National Practitioner Data Bank, Katharine Van Tassel

Katharine Van Tassel

In order to highlight the problems with the NPDB [National Practitioner Data Bank], this Article compares physician blacklisting with other forms of blacklisting. For example, both physician and sexual predator blacklisting programs have the same goals: allowing the public to engage in self-protection by preventing “predators” from traveling to new locations to prey on a new group of unsuspecting victims. And both sexual predators and physicians suffer similar stigmatization as the result of the “badge of infamy” that comes with being blacklisted. But this is where the similarities end. Accused sex offenders get all of the trappings of due process ...


Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel 2018 Concordia University School of Law, Boise

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians ...


Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel 2018 Concordia University School of Law, Boise

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is ...


The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel 2018 Concordia University School of Law, Boise

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory ...


Assumption Of Risk As A Defense To Negligence, Gregory S. Sergienko 2018 Concordia University School of Law

Assumption Of Risk As A Defense To Negligence, Gregory S. Sergienko

Greg Sergienko

This article will revisit the history of assumption of risk in California and elsewhere and suggest that the traditional doctrine should be modified and revived, despite the contrary approach of the Restatement (Third) of Torts. In the first part of the article, I will describe the ambiguities in the statements of assumption of risk that existed before the adoption of comparative negligence. I will show that Knight v. Jewett, which rejected assumption of risk, misinterpreted Li v. Yellow Cab Co., in which the California Supreme Court adopted a comparative negligence rule. Moreover, even if the Knight case was defensible on ...


Commodifying Consumer Data In The Era Of The Internet Of Things, Stacy-Ann Elvy 2018 New York Law School

Commodifying Consumer Data In The Era Of The Internet Of Things, Stacy-Ann Elvy

Boston College Law Review

Internet of Things (“IoT”) products generate a wealth of data about consumers that was never before widely and easily accessible to companies. Examples include biometric and health-related data, such as fingerprint patterns, heart rates, and calories burned. This Article explores the connection between the types of data generated by the IoT and the financial frameworks of Article 9 of the Uniform Commercial Code and the Bankruptcy Code. It critiques these regimes, which enable the commodification of consumer data, as well as laws aimed at protecting consumer data, such as the Bankruptcy Abuse Prevention and Consumer Protection Act, various state biometric ...


The Admissibility Of Sampling Evidence To Prove Individual Damages In Class Actions, Hillel J. Bavli, John Kenneth Felter 2018 Harvard Institute for Quantitative Social Science

The Admissibility Of Sampling Evidence To Prove Individual Damages In Class Actions, Hillel J. Bavli, John Kenneth Felter

Boston College Law Review

The 2016 Supreme Court decision in Tyson Foods, Inc. v. Bouaphakeo revived the use of “representative” or sampling evidence in class actions. Federal courts are now more receptive to class plaintiffs’ efforts to prove classwide liability and, occasionally, aggregate damages, with sampling evidence. However, federal courts still routinely deny motions for class certification because they find that calculations of class members’ individual damages defeat the predominance prerequisite of Rule 23(b)(3). As a result, meritorious classwide claims founder. In this paper, we combine legal and statistical analyses and propose a novel solution to this dilemma that adheres to the ...


By Reading This Title, You Have Agreed To Our Terms Of Service, Brian Larson 2018 Texas A&M University School of Law

By Reading This Title, You Have Agreed To Our Terms Of Service, Brian Larson

Brian Larson

By June of 2017, Facebook had two billion (that’s billion, with a ‘b’) users accessing it per month (Balakrishnan 2017). Facebook believes that each of those consumer end-users is bound by its end-user license agreement (EULA), which Facebook calls a “Statement of Rights and Responsibilities,” available to end-users from a small link in light gray text called “Terms” on every Facebook page. EULAs like this, associated with websites, mobile apps, and consumer goods with embedded software, and styled “terms of service,” “terms of use,” etc., may purport to impose a wide variety of contractual obligations on consumers, for example ...


How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson 2018 Seattle University School of Law

How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson

Seattle University Law Review

This Note takes a critical look at Commonsense Consumption Acts and how they are detrimental to the possibility of “Big Food” litigation. The tobacco industry was held accountable through the effective use of tort litigation (commonly referred to as “Big Tobacco” litigation), and the food industry could theoretically be held similarly accountable, but CCAs are preventing the possibility of similar reform. Therefore, in order for health reform to be as effective as tobacco reform, CCAs must be repealed in the states where they exist. Part I of this Note discusses why the food industry needs tort reform. Specifically, it argues ...


Don’T Let The Bed Bugs Bill: Landlord Liability For Bed Bug Infestations In Georgia, Megan M. Harrison 2018 Georgia State University College of Law

Don’T Let The Bed Bugs Bill: Landlord Liability For Bed Bug Infestations In Georgia, Megan M. Harrison

Georgia State University Law Review

Although the historical relationship between bed bugs and humans dates back to ancient Egypt, the common bed bug, or Cimex lectularius, vanished from the beds of Americans around World War II. In the late 1990s, however, our bloodsucking bedfellows returned. Bed bug infestations are a growing public health issue. Bed bugs are now found in all fifty states, with populations in five states reaching epidemic levels. Both the Environmental Protection Agency (EPA) and the Center for Disease Control and Prevention(CDC) consider bed bugs a “pest of significant public health importance."

Despite their name, bed bugs are not limited to ...


Not So Good: The Classification Of “Smart Goods” Under Ucc Article 2, Chadwick L. Williams 2018 Georgia State University College of Law

Not So Good: The Classification Of “Smart Goods” Under Ucc Article 2, Chadwick L. Williams

Georgia State University Law Review

Refrigerators can now tweet. Today, almost sixty years after the states widely adopted the Uniform Commercial Code (UCC), the line between goods and services is more blurred than ever. When the UCC was drafted, a good was the simple opposite of a service. A good was something “movable” and tangible, and a service was not. Article 2 of the UCC, which governs sales, limits its scope to goods.

However, because Article 2 was drafted long before the proliferation of so-called “smart goods,” courts continuously struggle to determine when a smart good falls within Article 2’s scope. Courts have developed ...


Dawn Of The Debt: The Increasing Problem Of Creditors Infecting The Discharge Injunction With Zombie Debt, Micah A. Smart 2018 University of Maine School of Law

Dawn Of The Debt: The Increasing Problem Of Creditors Infecting The Discharge Injunction With Zombie Debt, Micah A. Smart

Maine Law Review

The discharge injunction is an integral aspect of the “fresh start” that bankruptcy affords to many debtors. But there has been a growing threat to the viability of the bankruptcy discharge: zombie debt! Just when honest but unfortunate debtors think they have finally laid their overdue financial obligations to rest and moved on with their lives, zombie debt comes back to life in form of outdated and misleading credit reports that some debt collectors have been using to coerce payment on debts that should have died years prior. This Article discusses the motivation behind these questionable collection tactics and potential ...


Brief Of Amici Curiae Finance Regulation Scholars In Support Of Plaintiff's Motion For A Preliminary Injunction In English V. Trump, Patricia A. McCoy 2018 Boston College Law School

Brief Of Amici Curiae Finance Regulation Scholars In Support Of Plaintiff's Motion For A Preliminary Injunction In English V. Trump, Patricia A. Mccoy

Patricia A. McCoy

Professor McCoy was the lead author of an amicus brief in support of the lawsuit by CFPB Deputy Director Leandra English against the Trump Administration, asserting that she lawfully became the Acting Director of the Consumer Financial Protection Bureau under the Dodd-Frank Act.


Overcoming The Achilles' Heel Of Consumer Protection: Limiting Mandatory Arbitration Clauses In Consumer Contracts, Mindy R. Hollander 2018 Maurice A. Deane School of Law at Hofstra University

Overcoming The Achilles' Heel Of Consumer Protection: Limiting Mandatory Arbitration Clauses In Consumer Contracts, Mindy R. Hollander

Hofstra Law Review

No abstract provided.


Soda Taxes As A Legal And Social Movement, David A. Dana, Janice Nadler 2018 Northwestern Pritzker School of Law

Soda Taxes As A Legal And Social Movement, David A. Dana, Janice Nadler

Northwestern Journal of Law & Social Policy

No abstract provided.


The Impact Of Regulatory Measures Imposed On Initial Coin Offerings In The United States Market Economy, Joseph D. Moran 2018 Catholic University of America Columbus School of Law

The Impact Of Regulatory Measures Imposed On Initial Coin Offerings In The United States Market Economy, Joseph D. Moran

Catholic University Journal of Law and Technology

With the surge of technological advances across the financial market landscape, companies have implemented new ways of raising money that have sparked controversy among investors, legal practitioners, banks, and government regulators. This comment examines the technology behind Initial Coin Offerings (ICOs), and discusses the impact they have had on financial markets in the United States and across the globe. This comment also addresses the legal ramifications for companies issuing ICOs, and delves into the benefits of using blockchain technology as a means for transferring digital currencies and making business transactions. This comment further gives examples of current and potential regulations ...


License To Bill: The Validity Of Coupling Automatic Subscription Renewals With Free Trial Offers By Online Services, Koren Grinshpoon 2018 Fordham Law School

License To Bill: The Validity Of Coupling Automatic Subscription Renewals With Free Trial Offers By Online Services, Koren Grinshpoon

Fordham Intellectual Property, Media and Entertainment Law Journal

A prominent and expanding list of online services rely on a business model which pairs free trial offers with subsequent automatic subscription renewals (e.g., Amazon Prime, Blue Apron, etc.). Offering free trials to lure new users, while employing automatic renewal clauses in its terms of use to perpetuate recurring revenue, poses a substantial legal risk to online services. Numerous claims citing unfair and deceptive business practices are filed each year against such online services, primarily raising issues of informed consent, adequate disclosure, and notice. This Article reviews applicable federal law and regulations, as well as the applicable laws of ...


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