Law Commons^™

Abstractfinal.Docx, Madelyn J. Miles, Sarah Kercsmar

Madelyn Miles

Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square. This Article examines the question of how scientific methods and …

Reforming Fda Policy For Pediatric Testing: Challenges And Changes In The Wake Of Studies Using Antidepressant Drugs, Joanna K. Sax

Joanna K Sax

No abstract provided.

The Separation Of Politics And Science, Joanna K. Sax

Joanna K Sax

This article proposes that scientific inquiry regarding questions of fact should have an autonomous zone that is protected from politics. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains an empirical study that demonstrates that the public received inaccurate information in the debate over a highly politicized and controversial area of scientific inquiry, embryonic stem cell research. This article utilizes the data from the empirical study and public choice theory to explain that there are process defects; this economic model can help explain, but cannot be used to …

Private Certifiers And Deputies In American Health Care, Frank Pasquale

Frank A. Pasquale

So-called “public programs” in U.S. health care pervasively contract with private entities. The contracting does not merely involve the purchase of drugs, devices, information technology, insurance, and medical care. Rather, government agencies are increasingly outsourcing decisions about the nature and standards for such goods and services to private entities. This Article will examine two models of outsourcing such decisions. In private licensure, firms offer a stamp of approval to certify that a given technology or service is up to statutory or regulatory standards. Via deputization, firms can pursue a regulatory or law enforcement role to correct (and even punish) providers …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Joanna K Sax

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Evaluation Of Academic Scientists’ Responses To Situations That Pose A Conflict Of Interest, Joanna K. Sax

Joanna K Sax

The industry-academy relationship has many benefits, but it also has potential drawbacks, including potential conflicts of interest (e.g., when the profit motives of a private company unduly influence academic responsibilities). To date, policies intended to regulate or manage financial conflicts of interest appear to be unsatisfying and inadequate. The present study examined predictors of the responses of academic scientists and clinicians to hypothetical situations in which financial and other conflicts of interest may arise. Academic scientists and clinicians at five medical schools completed an anonymous survey that included vignettes that posed a potential conflict of interest. Participants indicated the likelihood …

Financial Conflicts Of Interest In Science, Joanna K. Sax

Joanna K Sax

This article proposes that an analysis of behavior may be utilized to create an effective policy addressing financial conflicts of interest. Importantly, this article focuses on the academics that conduct basic science. An understanding of the background of the public-private interaction is critical to fully appreciate the rise of the financial conflicts of interest in biomedical science. Part II of this Article describes the rise of financial conflicts of interest and the types of harms that can occur in the absence of effective policy to regulate financial conflicts of interest. Part III describes the current system addressing conflicts of interest, …

Access To Prescription Drugs: A Normative Economic Approach To Pharmacist Conscience Clause Legislation, Joanna K. Sax

Joanna K Sax

The goals of this Article are two-fold: (1) to explain that pharmacist conscience clause legislation may be expanded to areas concerning controversial biomedical research; and (2) to demonstrate that welfare economics can be applied to analyze pharmacist conscience clause legislation. Regarding the first goal, the broad language of existing and proposed conscience clause legislation creates an umbrella that allows a pharmacist to escape liability for refusing to fill a prescription for almost any type of medication. With respect to the second goal, this Article applies welfare economics to demonstrate that pharmacist conscience clauses are a part of tort law and …

The States "Race" With The Federal Government For Stem Cell Research, Joanna K. Sax

Joanna K Sax

The goal of this paper is to analyze and explain the impact of state legislation and funding on the future of stem cell research. Without federal law regulating stem cell research, funding by states and private organizations may spur competition to attract and retain leading scientists and industry in individual states. Alternatively, state-funded stem cell research may incite the federal government to react either positively or negatively to pre-empt state and private action. Traditionally, most support for scientific research comes in the form of grants from the National Institutes of Health (NIH). Due to the practical ban on stem cell …

Application Of Default Rules To Address Financial Conflicts Of Interest In Academic Medical Centers, Joanna K. Sax

Joanna K Sax

This Essay proposes that the rules governing financial conflicts of interest for scientists within the National Institutes of Health apply to scientists at Academic Medical Centers because scientists at both places receive federal funding. The rules governing financial conflicts of interest within the National Institutes of Health are stricter than the rules at Academic Medical Centers. The cornerstone of financial conflicts of interest rules at Academic Medical Centers is disclosure, which is inadequate. This Essay builds on previous work calling for significant changes to rules addressing financial conflicts of interest, and it promotes changes by calling for the application of …

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Joanna K Sax

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug. Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications are …

Introduction: Adolescent Medical Decision Making And The Law Of The Horse, Amanda C. Pustilnik, Leslie Meltzer Henry

Amanda C Pustilnik

No abstract provided.

Accountable Care Organizations In The Affordable Care Act, Frank Pasquale

Frank A. Pasquale

No abstract provided.

The Three Faces Of Retainer Care: Crafting A Tailored Regulatory Response, Frank Pasquale

Frank A. Pasquale

Retainer care arrangements allow patients to pay a retainer directly to a physician's office in order to obtain special access to care. Practices usually convert to retainer status by focusing their attention on those willing to pay a retainer fee, and dropping the majority of their patients, who are left to be absorbed by other practices. Also known as "boutique medicine," "concierge care," or "innovative practice design," retainer practices have drawn thousands of enthusiastic patients. They have also provoked scrutiny from politicians and consumer groups. Few recent developments in the business of medicine provoke emotional conflicts like retainer care does. …

Access To Medicine In An Era Of Fractal Inequality, Frank Pasquale

Frank A. Pasquale

Those in the richest countries have far more income and wealth than those in poor countries. Moreover, the most fortunate in the richest countries – particularly those in the top centile of the income distribution – are far richer than those around them. Most dramatically, even within that top centile, the richest of the rich have far more resources than even their elite peers. Like fractals, the patterns of distribution repeat at various levels. This pattern of fractal inequality ensures that spending that seems trivial to those at the top of an income distribution can overwhelm the purchasing power of …

William H. Sorrell, Attorney General Of Vermont, Et Al. V. Ims Health Inc., Et Al. - Amicus Brief In Support Of Petitioners, Kevin Outterson, David Orentlicher, Christopher Robertson, Frank Pasquale

Frank A. Pasquale

On April 26, 2011, the US Supreme Court will hear oral arguments in the Vermont data mining case, Sorrell v. IMS Health Inc. Respondents claim this is the most important commercial speech case in a decade. Petitioner (the State of Vermont) argues this is the most important medical privacy case since Whalen v. Roe. The is an amicus brief supporting Vermont, written by law professors and submitted on behalf of the New England Journal of Medicine

Ending The Specialty Hospital Wars: A Plea For Pilot Programs As Information-Forcing Regulatory Design, Frank Pasquale

Frank A. Pasquale

This chapter focuses on the need for more targeted assessment of the impact of market forces on communities. Pilot programs encourage experimentation in the delivery system without risking widespread disruption of care for the uninsured and emergency services. The Center for Medicare & Medicaid Services (CMS) has already embraced the idea of pilot programs in other contexts, and they could be especially appropriate if specialty hospitals were permitted in markets where general hospitals had a demonstrably poor record of community service. In such markets, cross-subsidization is probably already low, and specialty hospital threats to it are not as much of …

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Frank A. Pasquale

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale

Frank A. Pasquale

Normative analysis of cognition-enhancing drugs frequently weighs the liberty interests of drug users against egalitarian commitments to a "level playing field." Yet those who would refuse to engage in neuroenhancement may well find their liberty to do so limited in a society where such drugs are widespread. To the extent that unvarnished emotional responses are world-disclosive, neurocosmetic practices also threaten to provide a form of faulty data to their users. This essay examines underappreciated liberty-based and epistemic rationales for regulating cognition-enhancing drugs.

Grand Bargains For Big Data: The Emerging Law Of Health Information, Frank Pasquale

Frank A. Pasquale

No abstract provided.

For Health's Sake Be Not Colorblind, Ruth Hackford-Peer

Ruth Hackford-Peer

The United States’ past ideology of overt state-sanctioned racism has been replaced by a covert, seemingly race-neutral ideology. This Article looks at the history of racism in the United States and traces the recent shift in ideology and discourse about race, positing that the discourse of “colorblindness” powerfully maintains the racial status quo while purporting to advance race neutrality. Then, using affirmative action as the lens from which to view these shifts in ideology and discourse, this Article analyzes racial disparities in health and healthcare. It highlights some of the health consequences people of color face because they live a …

So-Called "Partial-Birth Abortion" Bans: Bad Medicine? Maybe. Bad Law? Definitely!, Ann Maclean Massie

Ann MacLean Massie

None available.

In Defense Of The Professional Standard Of Care: A Response To Carter Williams On "Evidence-Based Medicine", Ann Maclean Massie

Ann MacLean Massie

No abstract provided.

Why Can't We Do What They Do? National Health Reform Abroad, Timothy Stoltzfus Jost

Timothy S. Jost

This article describes how other countries organize and finance their health care systems, and how the performance of those health care systems compares with that of the United States. It also examines why the United States, unlike all other developed countries, has failed to provide universal access to health care services.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Concerns Regarding The Relationship Between Electronic Health Records And Malpractice Claims, Frederick J. White Iii, William P. Coleman Iii

Frederick J White III

No abstract provided.

A Submission To The New Zealand Government On The Plain Packaging Of Tobacco Products, Matthew Rimmer

Matthew Rimmer

EXECUTIVE SUMMARYThis submission draws upon a number of pieces of research and policy papers on the plain packaging of tobacco products including:1. Becky Freeman, Simon Chapman, and Matthew Rimmer, 'The Case for the Plain Packaging of Tobacco Products' (2008) 103 (4) Addiction 580-590.2. Matthew Rimmer, 'A Submission to the Senate Legal and Constitutional Committee on the Trade Marks Amendment (Tobacco Plain Packaging) Bill (Cth)', September 2011, https://senate.aph.gov.au/submissions/comittees/viewdocument.aspx?id=dabfcd75-9807-493f-bc99-4a7506bf493b3A. Matthew Rimmer, 'Tobacco's Mad Men Threaten Public Health', The Conversation, 23 September 2011, http://theconversation.edu.au/tobaccos-mad-men-threaten-public-health-34503B. Matthew Rimmer, 'Big Tobacco's Box Fetish: Plain Packaging at the High Court', The Conversation, 20 April 2012, https://theconversation.edu.au/big-tobaccos-box-fetish-plain-packaging-at-the-high-court-65183C. Matthew …