Digital Commons Network^™

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 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 …

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 …

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.

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 …

The Role Of Culture In Advocating For Accurate Diagnosis And Rating Of Veterans’ Psychological Disabilities, Hillary A. Wandler

Hillary A Wandler

To decide whether a veteran is compensated for a psychological disability connected to the veteran’s military service, the VA will usually require the veteran to be examined by a doctor, who will report on the veteran’s medical or psychiatric condition(s) and how well the veteran is functioning. The VA will rely heavily on the medical report to determine the severity of the veteran’s psychological disability. Advocates for disabled veterans help their veteran clients navigate this process and receive an amount of compensation that most appropriately compensates the veteran for how much the psychological disability actually impairs his ability to earn …

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 …

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 …

Which Is Greater: The Right To Parent Or The Rights Of A Parent? The Legal And Ethical Quandaries When A Minor Child Diagnosed With Cancer Wishes To Utilize Oocyte Cryopreservation And Advanced Reproductive Technology For Future Procreation., Jessica M. Hallgren

Jessica M Hallgren

No abstract provided.

South Dakota: Making Dollars And Sense Of Indian Child Removal, Rachael Whitaker

Rachael Whitaker

South Dakota- Making Dollars and Sense of Indian Child Removal By: Rachael Whitaker In 2004, a South Dakota Governor’s Commission report adamantly denied claims that the state’s Department of Social Services (DSS) is “harvesting Indian children as a cash crop” and “runs nothing more than a state sponsored kidnapping program.” National Public Radio (NPR) broke a story in 2011, claiming South Dakota removed Indian children for profit. Since NPR’s report, the state has remained tight-lipped, advocates have threatened litigation, and Congress has asked for answers. South Dakota has a small population and economy, and it receives almost half of its …

Federal Prohibition Of Medical Marijuana In Pain Management: Undue, Unimportant, And Irrational, Michael L. Timm Jr.

Michael L. Timm Jr.

This paper provides a review of the historical right of the people of the United States to seek, and use, alternative medicinal treatment options in the realm of managing both the pain and symptoms associated with a variety of illnesses. The focus then turns to the right involved: a patient’s ability to employ medical marijuana instead of a commonly prescribed narcotic or mass-market non-steroidal anti-inflammatory analgesic (NSAIA) drug to manage pain and increase quality of life under the advice and consent of a treating physician. No one article has argued that there is a fundamental, important, or at least recognizable …

Peril In The Patchwork: Ensuring Health Care Privacy For Children In Foster Care, Scarlet R. Smith

Scarlet R. Smith

No abstract provided.

Affordable Care And Medical Malpractice--How Two Broken Health Care Systems Will Only Get Worse Without Better Compromise, Heather N. Seigler

Heather N Seigler

Abstract When the Affordable Care Act was initially proposed, critics initially attacked the idea as “socialist,” damaging to small businesses, a proponent of big government, etc. Supporters have celebrated the Affordable Care Act’s passing and further celebrated when the United States Supreme Court upheld the constitutionality of the Affordable Care Act in a landmark decision last term. While attention has been placed on the general fears regarding the consequences of government healthcare and its effect on the medical field (both founded and unfounded), insufficient attention has been paid to how the Affordable Care Act will affect the legal community. In …

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 …

Clear Depictions Promote Clear Decisions: Drafting Abortion Speech-And-Display Statutes That Pass First And Fourteenth Amendment Muster, Ryan J. Pulkrabek

Ryan J Pulkrabek

Several states have passed legislation requiring physicians to take, display, and describe an ultrasound to their patients who are seeking an abortion. These statutes have been challenged under both the Fourteenth and First Amendments because the statutes place burdens on women who seek abortion and compel physician speech. Courts are divided on these questions and state legislatures need guidance as they consider reform. This Article proposes a model "speech-and-display" statute that is both consistent with the Constitution and good public policy. This model statute is designed to protect the mental health of patients and the life of the unborn by …