Law Commons^™

Transformations In Health Law Practice: The Interections Of Changes In Healthcare And Legal Workplaces, Louise G. Trubek, Barbara J. Zabawa, Paula Galowitz

Louise G Trubek

The passage and implementation of the Affordable Care Act is propelling transformations in health care. The transformations include integration of clinics and hospitals, value based care, patient centeredness, transparency, computerized business models and universal coverage. These shifts are influencing the practice of health law, a vibrant specialty field considered a “hot” area for new lawyers. The paper examines how the transformations in health care are intersecting with ongoing trends in law practice: increase in in-house positions, collaboration between medical and legal professionals, and the continued search for increased access to legal representation for ordinary people. Three health law workplace sites …

Navigating The Law Of Defense Counsel Ex Parte Interviews Of Treating Physicians, Joe Regalia, Drew Cass

Joe Regalia

The rising costs of litigation have hit those involved in healthcare-related cases — including patients, doctors, the courts and lawyers — perhaps hardest of all. Litigation costs have triggered rising malpractice insurance rates for doctors, extensive risk for malpractice attorneys on both sides of the aisle, clogged dockets for courts, and rising fees for clients. Not surprisingly, there is a constant debate about ways that litigation costs in these cases might be reduced. One practice that may alleviate at least some of this waste would cost nothing to implement and has the potential to create large savings: allowing ex parte …

Defining Death: A Call For The Reformation Of The Standard For Declaration Of Death In The Modern Era, Jayme M. Reisler

Jayme M Reisler

Prior to the mid 20th century, a declaration of death was a relatively definite determination because the functioning of each vital organ was inextricably linked to the other. With the advent of the positive-pressure mechanical ventilator, however, came the loss of integration among these organ systems. The ability to maintain metabolic functioning of a patient as well as the ability to successfully transplant viable organs have given rise to a host of legal issues revolving around the determination of death. The main issue that arises is two fold. On one hand, such medical technology can prolong an individual’s life even …

The Presentment Clause Meets The Suspension Power: The Affordable Care Act’S Long And Winding Road To Implementation, Mitchell Widener

Mitchell Widener

The presentment clause MEETs the Suspension Power: The Affordable Care Act’s Long and Winding Road to Implementation

Mitchell J. Widener

Abstract

To enact a law, the Presentment Clause of the Constitution mandates that both Houses of Congress present a bill to the President who either signs it into law or vetoes it. The Founders included this provision to prevent presidents from emulating King James II, who would routinely suspend Parliament’s laws to favor political constituents. Additionally, the Presentment Clause served to enhance the separation-of-powers principle implied in the Constitution.

Within the past year, President Obama has suspended multiple portions of …

Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith

Christopher R Smith

Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …

Curb Your Enthusiasm For Pigouvian Taxes, Victor Fleischer

Victor Fleischer

Pigouvian (or "corrective") taxes have been proposed or enacted on dozens of products and activities that may be harmful in excess: carbon, gasoline, fat, sugar, guns, cigarettes, alcohol, traffic, zoning, executive pay, and financial transactions, among others. Academics of all political stripes are mystified by the public’s inability to see the merits of using Pigouvian taxes more frequently to address serious social harms.

This enthusiasm for Pigouvian taxes should be tempered. A Pigouvian tax is easy to design—as a uniform excise tax—if one assumes that each individual causes the same amount of harm with each incremental increase in activity on …

The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee

Stacey B. Lee

In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, …

Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith

Christopher R Smith

Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …

Rationality, Insanity, And The Insanity Defense: Reflections On The Limits Of Reason, Theodore Y. Blumoff

Theodore Y. Blumoff

Individuals who suffer from chronic paranoid ideations live with deeply embedded conspiratorial delusions that are sometimes accompanied by unwanted visual and/or auditory stimuli, sometime neither: just psychotic delusions in which they feel as if they have lost control of their lives – and of course they have, albeit not from the performances of foreign forces. When those perceived forces persevere for even a fairly short period of time, they can dictate the performance of evil deeds that the individual ultimately feels helpless to oppose. What observations and findings from neuroscience make clear is that such individuals do not lack knowledge, …

Foreseeability Decoded, Meiring De Villiers

Meiring de Villiers

The Article reviews the conceptual and doctrinal roles of the foreseeability doctrine in negligence law, and analyzes its application in cases where a new technology or unexplored scientific principle contributed to a plaintiff’s harm. It adopts the common law definition of foreseeability as a systematic relationship between a defendant’s wrongdoing and the plaintiff’s harm, and demonstrates translation of the concept into the language of science so that the common law meaning of the foreseeability doctrine is preserved. An analysis of the foreseeability of HIV/AIDS as a blood-borne risk illustrates application of the concept to contemporary issues in medical science.

Ivf And The Law: How Legal And Regulatory Neglect Compromised A Medical Breakthrough, Steve Calandrillo

Steve P. Calandrillo

The rise of assisted reproductive technology like in vitro fertilization (IVF) as a method of human reproduction represents a remarkable medical achievement. It has allowed millions of infertile and same-sex couples to have children who were previously only the subject of their unrequited dreams. Live births and success rates have increased dramatically in the past decade, so much so that many fertility clinics “guarantee” a baby to clients who sign up. But with success comes inevitable downsides. Everyone knows that the price tag is steep, but given the demand, that obstacle seems to deter relatively few determined individuals. More insidious …

Virgin Fathers: Paternity Law, Assisted Reproductive Technology, And The Legal Bias Against Gay Dads, Elizabeth J. Levy

Elizabeth J Levy

In a small town called Bethlehem, the famous story goes, a young virgin woman gave birth to a son. At the heart of this story lies an enigma that would transform Western civilization: if a woman becomes pregnant without engaging in sexual intercourse with a man, then who is the father of her child? In the twenty-first century United States, the proliferation of assisted reproductive technology (ART) has given this metaphysical question a new significance. More specifically, how the law assigns paternity outside of sexual intercourse is relevant for all men who participate in ART and become “virgin fathers.” In …

Health Information Exchanges' Dirty Little Secret: The Infrastructure's Inability To Enforce Health Privacy Legislation, Gretchen E. Harper

Gretchen E Harper

Though the privacy of personal information may seem to be waning in American culture in the era of proliferating social media sites, the push for privacy in health information has remained. Unlike the restaurant check-in or the posted pet photo, data related to an individual’s health and morbidity is information our society continues to consider highly confidential. Along with the boom of electronic information exchanges and the ubiquity of personal data in various mediums, comes a great concern: privacy. Medical information is among the most sensitive types of personal information. The privacy of health information continues to be a vexing …

Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr.

Lance E Wyatt Jr.

The public’s interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court’s holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies. Unfortunately, this has not been the course that …

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 …