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Back Issues and Articles
Back Issues and Articles

Table of Contents
Table Of Contents
AJLM - [PDF] (Free Download)
American Journal of Law & Medicine Volume 38, Number 1 * 2012 Articles: 7 Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants Elizabeth R. Pike 63 Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency Trudo Lemmens & Candice Telfer 113 Semiconductor Chips, Genes, and Stem Cells: New Wine for New Bottles? Simone A. Rose 158 The National Residency Exchange: A Proposal to Restore Primary Care in an Age of Microspecialization Glen Cheng Notes And Recent Case Developments: 196 Cure Unwanted? Exploring the Chronic Lyme Disease Controversy and Why Conflicts of Interest in Practice Guidelines May Be Guiding Us Down the Wrong Path Johanna Ferguson 225 Recent Case Developments
Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants
Elizabeth R. Pike - [PDF]

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants. This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants-those in federal research and those abroad-are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances.
Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency
Trudo Lemmens & Candice Telfer - [PDF]

In this Article, we argue that access to information about clinical trials, which is a crucial tool for drug and medical device development, ought to be recognized as a fundamental component of the right to health. In the context of reproductive rights, the right to information has already been convincingly linked to the right to health. In that context, the argument has been made that women can only exercise their right to reproductive health services, such as abortion or birth control, if they also obtain information about these services. Admittedly, the relationship between the right to health and access to information in the reproductive rights context may seem more direct. Protection of the physical and mental integrity of women, thereby promoting their healthcare empowerment, clearly requires immediate access to information about reproductive health services. We argue, nevertheless, that there is also an undeniable link between access to clinical trials information and the right to health and that this should be used to promote the establishment of solid knowledge systems based on transparent data. This Article aims to show how this human rights discourse about the need for complex information systems can help curtail TRIPSbased arguments about the duty of states to protect data secrecy. This human rights-based claim is compatible with the view proffered by some legal scholars that clinical trials data are a public good and should be organized by the state, a claim made also in the health policy literature. We argue in this Article that situating access to information within the context of the right to health is not only reconcilable with this approach, but offers distinct advantages, particularly in the absence of fundamental reform of the clinical trials industry.
Semiconductor Chips, Genes, and Stem Cells: New Wine for New Bottles?
Simone A. Rose - [PDF]

This Article analogizes early semiconductor technology and its surrounding economics with isolated genes, stem cells, and related bioproducts, and their surrounding economics, to make the case for sui generis (of its own class) intellectual property protection for isolated bioproducts. Just as early semiconductors failed to meet the patent social bargain requiring novelty and nonobviousness in the 1980s, isolated genes and stem cells currently fail to meet the patent bargain requirements of non-obviousness and eligible subject matter that entitle them to traditional intellectual property protection. Like early semiconductor chip designs, nevertheless, the high cost of upstream bioproduct research and development, coupled with the need to sustain continued economic growth of the biotechnology industry, mandates that Congress provide some level of exclusive rights to ensure continued funding for this research. Sui generis intellectual property protection for isolated bioproducts would preserve the incentive to continue innovation in the field. As illustrated by the semiconductor industry, however, such sui generis protection for this technology must include limitations that address the need to provide an appropriate level of public access to facilitate downstream product development and enrich the public domain.
The National Residency Exchange: A Proposal to Restore Primary Care in an Age of Microspecialization
Glen Cheng - [PDF]

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.
Recent Court Decisions
Minnesota Supreme Court Hears Whether the Genetic Privacy Act Protects Newborn Blood Spot Samples Obtained Under the State's Newborn Screening Statutes - Bearder v. State of Minnesota
Shuyuan Hu - [PDF]

On November 16, 2011, the Minnesota Supreme Court reversed the Court of Appeals of Minnesota's decision to dismiss the plaintiffs' statutory claim that pursuant to the Genetic Privacy Act, the Minnesota Department of Health (MDH) must obtain written parental consent before storing newborn blood specimens or authorizing public-health research to be conducted with those samples. The named plaintiffs, nine families with twenty-five children, sued the MDH for violating the Genetic Privacy Act by collecting, storing, using, and disseminating newborn blood samples without obtaining written informed parental consent. As part of Minnesota's newborn screening program, the MDH collected and tested the blood samples of these twenty-five children for heritable and congenital disorders. The controversy at issue arose from the interplay between two state statutes: the newborn screening statutes, which authorizes the MDH's newborn screening program, and the Genetic Privacy Act, which prohibits the "collection, storage, use, and dissemination of genetic information" without "written informed consent." Unless the MDH receives a request to destroy a collected blood sample, portions of samples that remain after the screening tests are completed are retained indefinitely. Further, the MDH's contract with Mayo Medical Laboratories (Mayo) allows Mayo to use excess blood samples for studies unrelated to the newborn screening program if the samples have been de-identified or if Mayo has received written parental consent.
Denying Lawful Immigrants Access to State Healthcare Subsidies Violates the Equal Protection Provision of the Massachusetts Constitution - Finch v. Commonwealth Health Insurance Connector Authority
Lauren M. Schoeffler - [PDF]

The Supreme Judicial Court of Massachusetts held that a legislative appropriation denying state subsidies for the purchase of healthcare to lawfully-residing non-citizen immigrants fails strict scrutiny and thus, violates the equal protection provision of the Massachusetts Constitution. Plaintiffs, a group of Massachusetts non-resident aliens whose benefits were terminated by the appropriation, sued the Commonwealth Health Insurance Connector Authority (CCA), which is an independent public entity that administers the state healthcare subsidies. The plaintiffs alleged that CCA's denial of benefits was based solely on their alienage and thus, violated their rights under the Commonwealth's equal protection provision. CCA administers the Commonwealth Care Health Insurance Program ("Commonwealth Care"), an integral part of Massachusetts healthcare reform. Commonwealth Care "reduc[es] uninsurance in the commonwealth" by providing subsidies to aid eligible individuals6 in purchasing health insurance. Federal and state funds both support these premium payment subsidies for eligible Massachusetts residents. Under the aegis of a Medicaid "demonstration project," the federal government partially reimburses Commonwealth Care's expenditures on individuals who are eligible for federal benefits and does not offer reimbursement for federally ineligible individuals.
Ninth Circuit Rules Donors May Receive Compensation for Blood-Based Bone Marrow Transplant Donations - Flynn v. Holder
Mikaela Taberner - [PDF]

The Court of Appeals for the Ninth Circuit held that the 1984 National Organ Transplant Act (NOTA), which criminalizes the sale of human organs, does not apply to blood stems cells for bone marrow transplantation obtained through peripheral blood stem cell apheresis. NOTA makes it a felony to buy or sell any human organ to be used in transplantation, and defines "human organ" to include "bone marrow." According to this definition, the Ninth Circuit held that NOTA prohibits compensation for bone marrow transplants using a more invasive, surgical method of extracting bone marrow tissue, known as aspiration. The court found that that NOTA's prohibition of compensation for bone marrow donations does not violate the Equal Protection Clause of the Constitution, as Congress had a rational basis for prohibiting compensation for donations involving significant risks or the potential for commodification, while permitting compensation for donations of other bodily material, such as blood. NOTA's restrictions on compensation, however, do not apply to "bone marrow" transplantations using a newer apheresis method, which involves a less-invasive process that is similar to blood donations.