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Back Issues and Articles

Table of Contents
Table Of Contents
An Empirical Method for Materiality: Would Conflict of Interest Disclosures Change Patient Decisions?
Roy Spece, David Yokum, Andrea-Gale Okoro, and Christopher Robertson - [PDF]

The law has long been concerned with the agency problems that arise when advisors, such as attorneys or physicians, put themselves in financial relationships that create conflicts of interest. If the financial relationship is "material" to the transactions proposed by the advisor, then non-disclosure of the relationship may be pertinent to claims of malpractice, informed consent, and even fraud, as well as to professional discipline. In these sorts of cases, materiality is closely related to the question of causation, roughly turning on whether the withheld information might have changed the decision of a reasonable advisee (i.e., a patient). The injured plaintiff will predictably testify that the information would have impacted his or her choice, but that self-serving testimony may be unreliable. The fact finder is left to speculate about the counterfactual world in which the information was disclosed.
Just Say No to NOTA: Why the Prohibition of Compensation for Human Transplant Organs in NOTA Should Be Repealed and a Regulated Market for Cadaver Organs Instituted
Kristy Lynn Williams, Marisa Finley, and J. James Rohack - [PDF]

The United States faces a shortage of organs for transplantation; thousands of individuals die each year while waiting for organs. The organ donation system relies on altruism because the National Organ Transplantation Act (NOTA) prohibits donors from receiving valuable consideration for organs to be used for transplantation. This paper contains a proposal for a regulated market for cadaveric organs as a mechanism to increase the number of organs available for transplantation. A regulated market for cadaveric organs is appropriate in the United States for the following reasons: it is consistent with the numerous ways in which bodies are currently treated as commodities; it is unlikely to further disadvantage the poor; it would not expose organ recipients to undue harm; in the current organ transplantation system, everyone except the organ donor, benefits financially; the prohibition in NOTA is inconsistent with laws permitting next of kin to recover for damage to the body of a deceased family member; the protection of the dignitary interests of organs for donation is inconsistent with the current protections of the dignitary interests of human specimens; and permitting a market for organs promotes the American values of autonomy and liberty.
A "Duty" to Continue Selling Medicines
William Janssen - [PDF]

With disappointing frequency, shortages occur in the supply of prescription pharmaceuticals. Sometimes, those shortages persist for months (even years), and can implicate the only known medicine to treat a life-threatening medical condition. Sometimes, those shortages may also be due to avoidably negligent decisions in manufacture. Twice in the past two years, seriously ill patients-confronting just such medicine supply shortages-have resorted to the courts, demanding a judicial remedy for negligently caused supply interruptions to critically needed medicines. In doing so, they have asserted a bold litigating position: the law ought to impose upon drug manufacturers a legal duty to continue selling their medicines. In other words, once a pharmaceutical manufacturer enters a medicine market, it is obligated by law to remain there and preserve perpetually its medicine's supply. This claim of compelled-access-to-pharmaceuticals pushes to the very frontier of drug law in America.
There is More to Transparency than Meets the Eye: The Impact of Mandatory Disclosure Laws Aimed at Promoting Breastfeeding
Timothy D. Lytton, Barbara A. Dennison, Trang Q. Nguyen, and Janine M. Jurkowski - [PDF]

Requiring hospitals to inform patients of clinical best practices and to disclose performance data are two common regulatory strategies for improving healthcare. Proponents of such mandatory disclosure laws-sometimes referred to as "targeted transparency"-argue that they increase patient awareness and thereby create reputational incentives for hospitals to improve their performance. Evaluation of targeted transparency typically focuses on patient responses to information and changes in hospital behavior based on reputational concerns. This standard account, however, overlooks other important ways targeted transparency can influence hospital performance.
Digital Diagnosis: Privacy and the Regulation of Mobile Phone Health Applications
Jamie Lynn Flaherty - [PDF]

A woman living in a remote part of Kenya cannot see vision is clouded and dark, and she is miles away from a hospital. Fortunately, a doctor visiting her community lifts up a smartphone and takes a picture of her eye. The Portable Eye Examination Kit ("PEEK") mobile application ("app") on the smartphone then conducts a vision test and reports her diagnosis of cataracts.
Starting with the Man in the Mirror: Transsexual Prisoner Access to Transitional Surgeries Following Kosilek v. Spencer
Nina Garcia - [PDF]

Developed and organized along a strict gender binary assumption, the United States prison system network is arguably the single most sexually segregated institution in the United States. Contextualized by this rigidly classified system, transsexual prisoners face unique challenges both within correctional facilities and in America's courts. In recent decades, transsexual prisoners have become a significant subpopulation in U.S. prisons, and many transsexual prisoners have challenged prison conditions through a series of lawsuits, primarily by bringing Eighth Amendment claims for access to transition-related healthcare. Several of these lawsuits represent landmark victories in defining the scope of prisoners' right to health care as applied to transsexual prisoners. Of these landmark suits, Kosilek v. Spencer most widely expands the scope of what a federal court may consider a "serious medical need" under the Eighth Amendment. At first blush, Kosilek appears to open the door for some transsexual prisoners to receive sex reassignment surgery. However, this Note explores the ambiguities of Kosilek and discusses the control that departments of correction (DOCs) retain, post-Kosilek, in providing transitional surgeries such as facial feminization and sex reassignment surgeries. The United States District Court for the District of Massachusetts was the first court in the country to order a DOC to provide sex reassignment surgery to a transsexual inmate; the Massachusetts DOC therefore has no case law directly on point to inform it of the scope of its duties under the ruling. Nevertheless, this Note argues the Massachusetts DOC's duty, post-Kosilek, may be determined through the Eighth Amendment jurisprudence that concerns a prisoner's access to other unique medical treatments and surgeries, as well as through the body of case law on delayed provision of medical treatment.
Recent Court Decisions
Recent Case Developments: Federal Appellate Court Holds that the Affordable Care Act Does Not Authorize the Internal Revenue Service to Provide Tax Credits for Insurance Purchased on Federally-Facilitated Health Benefit Exchanges - Halbig v. Burwell
Omar Aniff - [PDF]

On July 22, 2014, in an opinion written by Judge Thomas B. Griffith, the United States Court of Appeals for the District of Columbia reversed an earlier district court decision allowing the Internal Revenue Service (IRS) to provide tax credits for qualified individuals through the thirty-six federally-facilitated health benefit exchanges. The D.C. Circuit held that the Patient Protection and Affordable Care Act (ACA) does not authorize tax credits for insurance purchased on federally-facilitated health benefit exchanges, thus prohibiting the IRS tax credits for the vast majority of individuals insured through the ACA.
Recent Case Developments: Federal Court Upholds Hawaii's Reduction of State-Funded Health Benefits for Alien Residents - Korab v. Fink
Ting Chiu - [PDF]

On April 1, 2014, the United States Court of Appeals for the Ninth Circuit ruled that the state of Hawaii did not violate the Equal Protection Clause of the Fourteenth Amendment by reducing state-funded health benefits for certain non-immigrant aliens.
Recent Case Developments: Broken Buffers and Fragile Bubbles - McCullen v. Coakley
Hannah Levin - [PDF]

On June 26, 2014, the Supreme Court held that a Massachusetts law prohibiting any person from "knowingly enter[ing] or remain[ing] on a public way or sidewalk adjacent to a reproductive health care facility within a radius of 35 feet of any portion of an entrance, exit or driveway of a reproductive healthcare facility" violated the First Amendment. While recognizing the government's legitimate interest in protecting public safety, the Court was adamant that burdens on "normal conversation" do not satisfy the narrow tailoring requirement for exceptions to free expression.