Law Commons^™

The Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer

Matthew Rimmer

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned …

Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer

Richard M Weinmeyer

Since the early 1990s, legislative and policy reforms have spurred the inclusion of women of childbearing potential in clinical research overseen by the National Institutes of Health and the U.S. Food and Drug Administration. Pregnant women have received no such help, however, despite the tremendous medical needs of this important demographic. This article argues that the exclusion of pregnant women from biomedical research in the United States constitutes sex discrimination as a matter of public policy given the interpretation of existing regulations governing human subjects protections. The current regulations that are in place guiding research on human subjects treat pregnant …

The Tbt Agreement And Tobacco Control Regulations, Lukasz A. Gruszczynski

Lukasz A Gruszczynski

The article analyses reports issued by the panel and the Appellate Body in the US – Measures Affecting the Productions and Sale of Clove Cigarettes dispute and attempts to assess their broader consequences for national tobacco control policies. Both reports are particularly important because they clarify the limits existing under WTO law, in particular the TBT Agreement, in this policy space. In this context, the article investigates whether the WTO dispute settlement bodies interpreted relevant rules of the TBT Agreement in a manner that provides countries with sufficient regulatory autonomy while ensuring at the same time that their technical measures …

The Who Protocol To Eliminate Illicit Trade In Tobacco Products: A Next Step In International Control Of Tobacco Products, Lukasz A. Gruszczynski

Lukasz A Gruszczynski

This report discusses the main provisions of the recently adopted WHO Protocol to Eliminate Illicit Trade in Tobacco Products. While recognizing the remarkable achievement of the global community in its efforts to curb illicit trade in tobacco products at the international level, the report also highlights those aspects of the Protocol that may undermine its effectiveness in the long-term perspective. In this context the enforcement capabilities of developing countries are cited as a main concern.

The Natural Rights Of Children, Walter E. Block

Walter E Block

No abstract provided.

Taxation Without Limitation: The Prohibited Pretext Doctrine V. The Sebelius Theory, Brett W. Hastings

Brett W Hastings

The Article posits that the Supreme Court erred in its ruling regarding the Affordable Care Act by overlooking a well established constitutional principle, dubbed the Prohibited Pretext Doctrine. This doctrine, which prohibits the exercise of a prohibited power through the pretextual use of a power granted, faded from memory due to the post Lochner era expansion of the Commerce Clause. Nevertheless, the doctrine remains valid law. In overlooking the Prohibited Pretext Doctrine, the Supreme Court established a new and contradictory doctrine, dubbed the Sebelius Theory. The Sebelius Theory turns the Prohibited Pretext Doctrine on its head by explicitly allowing the …

"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell

Frederick Mark Gedicks

Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

The Dangerousness Of The Status Quo: A Case For Modernizing Civil Commitment Law, Daniel A. Moon

Daniel C Moon

The states, private healthcare organizations, and those with psychiatric disorders are poorly served by the vague “dangerousness” standard endorsed by the United States Supreme Court in O’Connor v. Donaldson, as well as the state statutes that adhere to the high bar set in its holding. This paper explores involuntary civil commitment from a variety of perspectives in order to highlight these issues and to identify where improvements can be made. Specifically, this article proposes that the American Law Institute or the American Bar Association promulgate model rules intended to correct the system’s shortcomings and protect the various interested parties.

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

It’S A Mistake: Insurer Cost Cutting, Insurer Liability And The Lack Of Erisa Preemption Within The Individual Exchanges, Christopher R. Smith

Christopher R Smith

Within the new individual health insurance exchanges, ERISA preemption is inapplicable to State tort claims against individual exchange insurers, framing the question of whether or not individual exchange insurers, like employment-based insurers, should be protected from State tort liability. While there should be concern for an insurer’s ability to effectively manage costs and eliminate waste, beneficiaries should also have some sort of remedy against their insurer, when insurer cost cutting results in beneficiary harm. To balance the competing interests, a no-fault liability system should be adopted providing both limited liability for individual exchange insurers and preservation of injured beneficiaries’ remedies.

Health Care, Title Vi, And Racism’S New Normal, Dayna B. Matthew

Dayna B Matthew

HEALTH CARE, TITLE VI, AND RACISM’S NEW NORMAL Dayna Bowen Matthew ABSTRACT An estimated 84,570 minority patients die annually due to health care disparities that result from the unconscious racism that pervades American health care. Over a decade ago, the Institute of Medicine (IOM) reviewed the egregious inequalities that black and brown patients suffer when they seek medical care for heart disease, diabetes, cancer, asthma, pain, strokes and virtually every disease, illness or malady. The IOM report identified physician stereotypes, bias, and prejudice as a possible reason for these disparities, but could not explain exactly why biases caused minority patients …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

Privacy As A Tool For Antidiscrimination, Jessica Roberts

Jessica L. Roberts

Traditionally, laws that protect privacy and laws that prohibit discrimination have been considered distinct kinds of legal protections. This Essay challenges that binary on both practical and theoretical grounds. Using the Genetic Information Nondiscrimination Act (GINA) as a case study, it argues that lawmakers can use privacy law to further antidiscrimination goals. GINA, which prohibits genetic-information discrimination in health insurance and employment, does more than simply outlaw discriminatory conduct. It also prohibits employers from requiring—or even requesting—their employees’ genetic information. While GINA’s privacy and antidiscrimination protections have previously been viewed as discrete, this Essay reads them in concert, arguing that …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

Consentimiento Informado: Un Derecho Fundamental En La Relación Médico Paciente., Guillermo Castorena

Guillermo Castorena

Este derecho está basado en el principio de autonomía. Se trata de un derecho humano del paciente, aunque por otra parte, podría verse también como un elemento estructural esencial del contrato de servicios médicos, esto es, la esencia misma de ese acto médico-jurídico. De esa manera, la voluntad del paciente para someterse a un procedimiento médico o quirúrgico con fines diagnósticos, terapéuticos, rehabilitatorios o paliativos, se formará por un proceso de información, entendimiento, razonamiento y manifestación de la voluntad.

The Issue Is Being Intersex: The Current Standard Of Care Is A Result Of Ignorance, And It Is Amazing What A Little Analysis Can Conclude., Marla J. Ferguson

marla j ferguson

The Constitution was written to protect and empower all citizens of the United States, including those who are born with Disorders of Sex Development. The medical community, as a whole, is not equipped with the knowledge required to adequately diagnose or treat intersex babies. Intersex simply means that the baby is born with both male and female genitalia. The current method that doctors follow is to choose a sex to assign the baby, and preform irreversible surgery on them without informed consent. Ultimately the intersex babies are mutilated and robbed of many of their fundamental rights; most notably, the right …

A Submission To The House Of Representatives Standing Committee On Social Policy And Legal Affairs On The Intellectual Property Laws Amendment Bill 2013 (Cth), Matthew Rimmer

Matthew Rimmer

The amendments contained in the Intellectual Property Laws Amendment Bill 2013 (Cth) are designed to provide safeguards in relation to patent law and the public interest.In the 2012 case on plain packaging, the Chief Justice of the High Court of Australia, Robert French, emphasized that the role of intellectual property law is to promote public objectives. His Honour observed: ‘There are and always have been purposive elements reflecting public policy considerations which inform the statutory creation of intellectual property rights.’ Discussing the role of patent law, Chief Justice Robert French commented:The Patents Act 1990 (Cth) provides that a patent gives …

Regulating For The Public Health: Perchlorate Regulation Under The Safe Drinking Water Act Exceeds Statutory Authority, Mary Jones

Mary Jones

This paper recommends rethinking the statutory framework of the Safe Drinking Water Act (SDWA) to provide a more robust rubric, to include a scientific and objective focus, for proper regulation. The SDWA is evaluated through the lens of upcoming perchlorate regulation due in February 2013.

The United States Environmental Protection Agency (EPA) regulates acceptable contaminant levels and decontamination processes for all public water systems, pursuant to statutory authority granted by the SDWA. Where the policy at work is admirable, the execution falls short.

Perchlorate occurs naturally, but also as a by-product to rocket fuel, firework, and other explosive constructions. Scientific …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

Virginia: How Does The Affordable Care Act Affect Workers’ Compensation In The Commonwealth?, Elisabeth M. Wright

Elisabeth M Wright

No abstract provided.

The University's Right To Quarantine: Analyzing Student Health Laws With Regards To Epidemic Situations, Audra Phillips

Audra Phillips

No abstract provided.

Innovator Liability: Restoring Symmetrical Rights To Consumers Of Generic Drugs, Stanford L. Moore

Stanford L Moore

No abstract provided.

"Health Care For All:" The Gap Between Rhetoric And Reality In The Affordable Care Act, Vinita Andrapalliyal

Vinita Andrapalliyal

The rhetoric of “universal health care” and “health care for all” that pervaded the health care debate which culminated in the Patient Protection and Affordable Care Act (ACA)’s passage. However, the ACA offers reduced to no protections for certain noncitizen groups, specifically: 1) recently-arrived legal permanent residents, 2) nonimmigrants, and 3) the undocumented. This Article explores how the Act fails to ensure “health care for all,” demonstrates the gap between rhetoric and reality by parsing the ACA’s legislative history, and posits reasons for the gap. The ACA’s legislative history suggests that legislators’ biases towards these noncitizen groups, particularly with respect …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Combating Obesity With A Right To Nutrition, Paul Diller

Paul Diller

Domestic and international law have, in different ways, recognized a human right to food since the twentieth century. The original reason for this recognition was the need to alleviate a particular type of food insecurity—“traditional” hunger, as manifested in conditions like malnutrition and underweight. The current public-health crisis of obesity, however, demands a reconsideration of this right. The food environment in the United States today is awash in high-calorie, low-nutrient food products that are often cheaper, on a relative basis, than more nutritious foods, leading to the overconsumption of the former by much of the American population. Merely ensuring a …

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

Pirates Of The Australian Election, Matthew Rimmer

Matthew Rimmer

“Pirate parties” have proliferated across Europe and North America in the past decade, championing issues such as intellectual property (IP), freedom of speech, and the protection of privacy and anonymity.This year, the movement hit Australian shores: The Pirate Party Australia was officially registered by the Australian Electoral Commission in January 2013. (You can read its principles and platform here.)“More than ever before, there is a necessity in Australia for a party that holds empowerment, participation, free culture and openness as its central tenets”, Pirate Party founder Rodney Serkowski said in a press release announcing the group’s successful registration. Their first …