Law Commons^™

Harder, Better, Faster Stronger: Regulating Illicit Adderall Use Among Law Students And Law Schools, Jennifer Schiffner

Jennifer Schiffner

The widespread illicit use of Adderall as a performance enhancer raises significant challenges for law schools and for law students entering the legal profession. Adderall, a stimulant-based performance enhancer prescribed for those with juvenile and adult attention deficit (ADD) and attention-deficit hyperactivity disorder (ADHD), increases a person’s ability to concentrate by stimulating the production of dopamine and norepinephrine in the brain. Taken without a prescription for ADD or ADHD, Adderall over-stimulates the brain allowing for super-enhanced focus with a simple pill. For law students, the allure of this Controlled Substances Act Schedule II drug is simple: efficiency. However, despite easing …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

All I Need Is A Miracle And A Constitutional Right To Access It: The Rights Of The Terminally Ill Reconsidered, Amy M. Dudash

Amy M. Dudash

In Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, Abigail Alliance sought to enjoin the FDA from preventing the sale of investigational drugs to terminally ill patients. The Alliance argued that terminally ill patients have a constitutional right to access investigational drugs under the Due Process Clause of Fifth Amendment. In order to determine if a right to non-FDA approved drugs existed under the Due Process Clause, the court applied the test laid out in Washington v. Glucksberg. An en banc panel of the D.C. Circuit Court of Appeals held that terminally ill patients did not have …

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

Twenty-Five Years Of Health Law Through The Lens Of The Civil False Claims Act, Joan H. Krause

Faculty Publications

No abstract provided.

Medical Research Regulation After More Than Twenty-Five Years: Old Problems, New Challenges, And Regulatory Imbalance, Richard S. Saver

Faculty Publications

No abstract provided.

Enabling Responsible Public Genomics, John M. Conley, Adam K. Doerr, Daniel B. Vorhaus

Faculty Publications

No abstract provided.

Negligent Speech Torts, Deana Pollard Sacks

Deana A Pollard

Recent research on the effects of violent media on children has elevated longstanding controversy over civil liability for speech to a new level. NEGLIGENT SPEECH TORTS reviews and challenges prevailing negligent speech jurisprudence and proposes wholesale reform to the rules governing civil liability for unreasonably dangerous speech. The prevailing Brandenburg incitement test is inapposite as applied to modern dangerous speech cases and should be replaced by a “constitutionalized” negligence paradigm to reconcile First Amendment and tort policies. The Supreme Court has constitutionalized various other speech torts – such as defamation, privacy, and emotional torts – by raising their prima facie …

An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin

Margarita Rubin

ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …

Accountable Care Organizations: The Clash Of Liability Standards With Cost Cutting Goals, Christopher R. Smith Esq.

Christopher R Smith

This article seeks to examine the conflict between non-cost conscious medical malpractice liability standards and health care cost cutting measures within the context of Accountable Care Organizations (“ACOs”) under the new health care reform law. The article begins by providing an overview of the high level of health care spending within the United States health care system in order to provide a context for better understanding policymakers’ push for cost cutting measures, including ACOs. The article then examines the tension between cost containment efforts and provider medical liability standards through an examination of the “stuck in the middle” mentality that …

Improving The Safety Of Central Nervous System Stimulants, Anne Kulli

Anne Kulli

Anonymity removed in this document.

The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin

Baylen J. Linnekin

For several decades, California has served as the epicenter of the American food scene. California produces one-third of the nation’s food, is home to one in eight American consumers, and boasts a staggering 90,000 restaurants. California is also where eating trends are born, and where fast food, organic food, and Napa Valley wines became durable icons of American culinary culture.

The state’s place atop the national food chain, though, is in jeopardy. In recent years, California legislators have pursued regulations that negatively impact many important agricultural and culinary trends. State and local governments have banned or severely regulated a veritable …

Towards A New Moral Paradigm In Health Care Delivery: Accounting For Individuals, Meir Katz

Meir Katz

For years, commentators have debated how to most appropriately allocate scarce medical resources over large populations. In this paper, I abstract the major rationing schema into three general approaches: rationing by price, quantity, and prioritization. Each has both normative appeal and considerable weakness. After exploring them, I present what some commentators have termed the “moral paradigm” as an alternative to broader philosophies designed to encapsulate the universe of options available to allocators (often termed the market, professional, and political paradigms). While not itself an abstraction of any specific viable rationing scheme, it provides a strong basis for the development of …

The Rise, Fall And Rise Again Of The Genetic Foundation For Legal Parentage Determination, Yehezkel Margalit

Hezi Margalit

Recently, we have witnessed dramatic changes in the formation of the family and parenthood. One of the results of those shifts is a growing number of children growing up outside of the traditional marriage framework. Therefore, the dilemma of determining a child's parentage, which was usually resolved by a legal fiction as to the child's legal parents, is becoming increasingly problematic. It is appropriate that any discussion of the establishment of legal parentage should start with a study of the rise of the most popular modern model, the genetic model.

It is relevant to point out that from the beginning …

Whom Would Jesus Cover? A Biblical, Ethical Lens For The Contemporary American Health Care Debate, Jeffrey R. Baker

Jeffrey R Baker

The United States spends more per capita on health care than any other developed nation by orders of magnitude, yet nearly 47 million people, including nearly 9 million children, do not have health insurance. The vast majority of uninsured Americans are working poor people who earn too much to be eligible for public coverage but who earn too little to afford private insurance or exorbitant private care. Two questions spring from this “gap” to implicate Biblical ethical precepts. First, is access to health care for our uninsured neighbors a moral issue that should spur redress by conscientious communities? Second, if …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

Data Sharing, Latency Variables And The Science Commons, Jorge L. Contreras

Jorge L Contreras

Over the past decade, the rapidly decreasing cost of computer storage and the increasing prevalence of high-speed Internet connections have fundamentally altered the way in which scientific research is conducted. Led by scientists in disciplines such as genomics, the rapid sharing of data sets and cross-institutional collaboration promise to increase scientific efficiency and output dramatically. As a result, an increasing number of public “commons” of scientific data are being created: aggregations intended to be used and accessed by researchers worldwide. Yet, the sharing of scientific data presents legal, ethical and practical challenges that must be overcome before such science commons …

Bermuda's Legacy: Policy, Patents And The Genome Commons, Jorge L. Contreras

Jorge L Contreras

The multinational effort to sequence the human genome generated vast quantities of data about the genetic make-up of humans and other organisms. But, in some respects, even more remarkable than the impressive quantity of data generated by the human genome project (HGP) is the speed at which that data has been released to the public. At a 1996 summit in Bermuda, leaders of the scientific community agreed on a groundbreaking set of principles requiring that all DNA sequence data be released in publicly-accessible databases within twenty-four hours after generation. These “Bermuda Principles” contravened the typical practice in the sciences of …

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

Law And Mental Health: A Relationship In Crisis? (Introduction), Sheila Wildeman

Articles, Book Chapters, & Popular Press

An Introduction to the Lectures of Supreme Court of Canada Chief Justice Beverley McLachlin and Nova Scotia Provincial Court Judge Anne Derrick. What is the significance of the rule of law to the area of professional knowledge and practice that is “mental health”—or to the interaction of those two aspirational, one might say euphemistically-named social systems: the mental health and justice systems? This question centres upon the rule of law—specifically, I suggest (as I relate further in closing), a thick conception of the rule of law grounded in an ideal of state-subject reciprocity1 —and not, or not directly, upon the …

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

Erisa Preemption Of State 'Play Or Pay' Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Avoiding The Avoidable: Why State Laws Need To Protect Kids From Airbags, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Memory And Punishment, Orlando Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered — by the offender, by the sentencing authority, …