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Law & Health Care Newsletter, V. 18, No. 1, Fall 2010

Law & Health Care Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Fall 2010

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque

Canadian Journal of Law and Technology

In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …

Patient Safety Law: Regulatory Change In Britain And Canada, Fiona Mcdonald

PhD Dissertations

Did governments in different countries regulate common concerns about patient safety differently? If so how and why did they do this? This thesis undertakes a historical comparison of the regulation of patient safety in Britain and Canada between 1980 and 2005. These jurisdictions began the period with very similar regulatory frameworks, but by 2005 there were distinct differences in each jurisdiction‘s regulatory response to patient safety. Britain was very actively regulating all aspects of service provision within its health system in the name of patient safety, whereas Canada‘s regulatory direction showed adherence to the 1980s model with only scattered incremental …

Governance Of Health Research Involving Humans In Developing Countries: The Nigerian Example, Cheluchi Onyemelukwe

PhD Dissertations

An intense debate has occurred regarding research involving humans in developing countries in recent years. Research in this area has focused mainly on examining the ways in which the economic inequalities in healthcare between developing countries and developed countries have affected the types of research conducted in developing countries by external sponsors. Research has also focused on how these inequalities, and the difficulties in applying the international ethical guidelines, give rise to ethical concerns and controversies. Recent literature has therefore examined several ethical concerns in health research in developing countries. What is missing in the literature on research oversight in …

Health Law Outlook - Volume 4, Issue 1 (Fall 2010)

Health Law Outlook (archive)

Inside this issue:

• Health Care Reform's Forgotten Youth: The Need to Expand Health Coverage for Youth Aging Out of Foster Care, Anne Collart
• The Genetic Information Nondiscrimination Act: Examining Its Impact on Unintended Consequences Minority Communities and Criminal Justice, Melody Hsiou
• Are Children Safe at School?: An Evaluation of H.R. 4247, Stephanie Kozic
• Zoning Laws: A Potential Local Government Tool for Decreasing Childhood Obesity in Low-Income Areas, Cynthia Furmanek
• Violence From a Legal Perspective: Child Abuse & Mandatory Reporting Laws, Brandon Wolff

Family Law And Estate Law - Reproductive Technology - Use Of Artificial Reproductive Technologies After The Death Of A Parent, Lisa Medford

University of Arkansas at Little Rock Law Review

No abstract provided.

Brave New Eugenics: Regulating Assisted Reproductive Technologies In The Name Of Better Babies, Kerry L. Macintosh

Faculty Publications

Infertile men and women have been using assisted reproductive technologies (ART) to conceive children since the first "test-tube baby" was born in 1978. During the past decade, however, the federal government has begun to clamp down on ART, asserting safety concerns as grounds forbanning novel technologies such as cloning, nuclear transfer, and ooplasm transfer.

Some scholars and policymakers now want to extend governmental regulation to include conventional ART such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). They claim children conceived through ART face an increased risk of birth defects and other health problems.

This Article examines the …

Stateless Crimes, Legitimacy, And International Criminal Law: The Case Of Organ Trafficking, Leslie Francis, John Francis

Utah Law Faculty Scholarship

Organ trafficking—coercion for the purpose of removal of organs (United Nations 2000; GTZ 2004)—is recognized as a significant international problem. Yet unlike sex trafficking or trafficking in children, it is largely left out of international criminal law regimes and to some extent of domestic criminal law regimes as well. It does not come within the jurisdiction of the ICC, except in very special cases such as when it is conducted in a manner that conforms to the definitions of genocide or crimes against humanity. Although the United States Code characterizes trafficking as “a transnational crime with national implications,” (22 U.S.C. …

Rhetorical Federalism: The Value Of State-Based Dissent To Federal Health Reform, Elizabeth Weeks Leonard

Scholarly Works

This Article makes the affirmative case for the widespread trend of state resistance to the recently enacted, comprehensive federal health reform law, the Patient Protection and Affordable Care Act of 2010, or ACA. A significant number of states have engaged in various forms of objection to the new federal laws, including filing lawsuits against the federal government, enacting laws providing that ACA will not apply to residents of the state, and refusing to cooperate with implementing the new laws. This Article identifies reasons why those actions should not be disregarded simply as Tea Party antics or election-year gamesmanship but instead …

Panelist, Justice Brennan: Liberal Champion, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.

How The Rise Of Federal Bureaucratic Powers Challenges The Role Of Courts In Adjudicating Claims Of Injury Inflicted By Prescription Drugs, Denise K. Top

Golden Gate University Law Review

This Comment uses the recent Paxil litigation as an example of how the rise of federal bureaucratic powers, specifically those exercised by the FDA to administer the Food Drug and Cosmetic Act (hereinafter "FDCA"), increasingly challenge the role of courts in adjudicating tort claims of injury inflicted by prescription drugs. Part I explains the current labeling requirements for prescription drugs. Part II describes product liability law regarding claims involving prescription drugs. Part III analyzes the drug manufacturers' and FDA's defenses to state tort claims, specifically preemption and primary jurisdiction. Part IV discusses the current law as it applies to the …

Murder And The Mmpi-2: The Necessity Of Knowledgeable Legal Professionals, Tracy O'Connor Pennuto

Golden Gate University Law Review

Part I of this Comment discusses the basic structure and purpose of the MMPI-2, the development and evolution of the MMPI into the MMPI-2, and reliability and validity issues. Part II provides a basic understanding of the correct administration, scoring, and interpretation of the MMPI-2 and describes standards for expert testimony. Part III presents a historical overview of the use of the MMPI-2 in court. The different types of cases in which the MMPI-2 is used are discussed along with the many applications of its use. Part IV describes the legal standards of admissibility of scientific evidence in court and …

Going Beyond Parents And Institutional Review Boards In Protecting Children Involved In Nontherapeutic Research, Efi Rubinstein

Golden Gate University Law Review

Part I of this Comment traces the development of ethical and legal guidelines for current informed consent procedures. Part II outlines the extent of parental authority in volunteering children for research, including legal exceptions to parental permission and possible limitations imposed on parental rights by the courts. Part III challenges the assumption that parents can and will always act in their child's best interest. Part IV argues that institutional review boards cannot be relied upon to protect children when parents fail to do so. Finally, Part V proposes possible improvements to the problematic evaluation process of parents and institutions when …

The Primary Care Safety Net: Strained, Transitioning, Critical, Jessamyn Taylor

National Health Policy Forum

This background paper examines the primary care safety net. It describes key primary care safety net providers, including federally qualified health centers, free clinics, local health departments, and safety net hospital outpatient departments and clinics, among others. The paper also explores the changing role of the primary care safety net in a post–health reform marketplace.

Not-So-Equal Protection: Securing Individuals Of Limited English Proficiency With Meaningful Access To Medical Services, Barbara Plantiko

Golden Gate University Law Review

This Comment focuses on how language discrimination manifests itself in various health care settings and how it deprives individuals with limited or no English proficiency of access to a variety of essential medical services. Part I of this article provides a brief overview of how courts and the legislature have dealt with language discrimination. Part II addresses the current conflict of the law regarding the difficulties in assessing and proscribing such discrimination in the medical context. Part III explores why the current case law and legislative efforts in this area are inadequate. Part IV proposes a solution as to how …

High Hopes: Public Health Approaches To Reducing The Need For Health Care, Michele J. Orza

National Health Policy Forum

Driven in part by a desire to contain health care costs, policymakers are looking beyond medical care for opportunities to reduce the need for expensive services. This paper briefly reviews current public health concepts and strategies for improving health that emphasize nonmedical factors such as behavior, socioeconomic status, and environment. It also provides examples of how these concepts and strategies undergird many of the public health provisions of the Patient Protection and Affordable Care Act, other legislation, and several programs and initiatives. These concepts include prevention, health in all policies, global health, the One Health Initiative, and climate change and …

Seven-Sky V. Holder - U.S. Reply Brief, Eric Holder

Patient Protection and Affordable Care Act Litigation

No abstract provided.

Renewed Compassion For The Dying In Compassion In Dying V. State Of Washington, Cara Elkin

Golden Gate University Law Review

In Compassion In Dying v. State of Washington, three patients, five physicians, and a non-profit organization called Compassion in Dying challenged the constitutionality of a Washington State statute which bans all assisted suicide, including physician-assisted death requested by terminally ill, mentally competent adults. The district court held the statute unconstitutional for violating the patient-plaintiffs' Fourteenth Amendment liberty interests and equal protection rights." A three-judge panel of the Ninth Circuit held that no constitutional right to die exists under either the Due Process or Equal Protection clauses of the Fourteenth Amendment of the United States Constitution. The Ninth Circuit granted review …

American Academy Of Pediatrics V. Lungren: California's Parental Consent To Abortion Statute And The Right To Privacy, Michael Grimm

Golden Gate University Law Review

This comment will discuss the background right to privacy jurisprudence, examine the grounds under which the court of appeal decided the case, and review appellants' and respondents' arguments. Based upon the opposing parties' arguments and controlling precedent, the author will explain why the California Supreme Court should affirm the court of appeal's decision.

X Marks The Spot While Casey Strikes Out: Two Controversial Abortion Decisions, Sabina Zenkich

Golden Gate University Law Review

This article studies and defines abortion law in Ireland after X and in the United States after Casey. It addresses how these decisions affect Irish and American women's rights, respectively, to secure an abortion. It also scrutinizes the justices' opinions and criticizes the reasoning for their holdings. This article argues that both Courts changed their nations' straightforward abortion laws to reach decisions that the courts felt would be more palatable to their respective political constituencies and satisfy their own subjective beliefs. On the one hand, the Irish court declined to abide by the traditionally conservative position denying abortion rights as …

Reforms In Medical Device Regulation: An Examination Of The Silicone Gel Breast Implant Debacle, Rebecca Vveisman

Golden Gate University Law Review

This article will consider the regulatory policies of the FDA in protecting the health of the nation's women, particularly its handling of silicone gel breast implants and its policing of the leading implant manufacturer, Dow Corning Corporation. While this article recognizes the various difficult problems which the FDA must address in protecting consumers from unsafe food, drugs, and medical devices, it also recognizes the need for reform. This article will describe what resulted from the tragedies of diethylstilbestrol (DES) and the Dalkon Shield. With these failures in mind, this article will examine present FDA policies, describe social forces outside of …

The Forgotten And Neglected: Pregnant Women And Women Of Childbearing Age In The Context Of The Aids Epidemic, Carol Beth Barnett

Golden Gate University Law Review

This article will explore why pregnant women with HIV disease have become the focus of some of the most deeply-rooted value judgments about women and HIV, and how certain governmental policies, including state statutes, and local medical practices by hospitals, doctors and health clinics, raise reproductive freedom issues for pregnant women and women of childbearing age in the context of AIDS and HIV infection. Part I discusses the overall demographic picture of women with HIV disease, particularly as it relates to the interconnection between substance abuse and the transmission of HIV disease to women, and its affect on the numbers …

Love V. Superior Court: Mandatory Aids Testing And Prostitution, Karin Zink

Golden Gate University Law Review

The AIDS epidemic has brought one of our most fundamental constitutional rights into sharp focus in California. The relationship between the Fourth Amendment right to be free from unreasonable searches and seizures and the government's ability to mandate AIDS testing was the topic of a recent California case, Love v. Superior Court. In a unanimous decision the California Court of Appeal upheld section 1202.6 of the California Penal Code [hereinafter § 1202.6] mandating AIDS testing of persons convicted of soliciting an act of prostitution. The court held that the California law does not violate the Fourth Amendment's prohibition against unreasonable …

In Vitro Fertilization Through Egg Donation: A Prospective View Of Legal Issues, James M. Treppa

Golden Gate University Law Review

As reproductive techniques continue to advance, many legal and ethical questions surrounding the use of some of these techniques remain unanswered. One such technique is IVF through the use of egg/oocyte donation. The lack of legal or statutory parameters regarding the use of IVF egg donation is a direct consequence of judicial and legislative failure to promulgate guidelines regarding noncoital reproduction. As many judges continue to point to legislators for guidance, proposed bills stagnate at the hearing stage.

Hiv Disease: Criminal And Civil Liability For Assisted Suicide, Ann Grace Mccoy

Golden Gate University Law Review

This article first traces the evolution of attitudes and subsequent laws regarding suicide and assisted suicide. Secondly, the criminal and civil liability of assisted suicide is assessed on the basis of California case law. Lastly, this paper will discuss the applicability of the defenses of the right of privacy and the right of autonomy to acts of suicide and assisted suicide. This discussion will focus on the right of a person with HIV disease to enlist the assistance of the medical profession to make his or her death as quick and as painless as possible, a practice which under the …

Searching For Proper Judicial Recognition Of Hospital Ethics Committees In Decisions To Forego Medical Treatment, Carol A. Murphy

Golden Gate University Law Review

The issue of withdrawing or withholding life-sustaining medical treatment arises with increasing regularity in the United States, prompted by a growing elderly population and constant technological advances. A Hospital Ethics Committee (HEC) may be utilized to assist in making treatment decisions for incompetent patients, but there is inconsistency in the deference given to HECs by courts. Neither federal nor state statutes have addressed the proper role of HECs in health care decisionmaking, and common law on the subject is conflicting. This comment will explore the levels of judicial scrutiny applied to HEC decisions regarding life-sustaining medical treatment and explore the …

The American "Right" To Health Care - An Idea Whose Time Has Come?, Nancy E. Cropley

Golden Gate University Law Review

No abstract provided.

Nursing And The Future Of Health Care: The Independent Practice Imperative, Nancy A. Hoffman

Golden Gate University Law Review

In recent years an ever increasing problem has emerged within the health care delivery system in the United States: there is a shortage of registered nurses to meet patient care needs. This shortage raises serious public policy concerns about how society will be assured of quality health care and who will provide that care in the future. An awareness of the problems that have led to the nursing shortage and exploration of alternatives to the present health care delivery system are required in order to remedy the problem. The efforts of the nursing profession to overcome the effects of the …

Civil Remedies For Therapist-Patient Sexual Exploitation, Laurie A. Morin

Golden Gate University Law Review

This article explores the clinical and legal issues raised in civil actions brought by patients against their therapists for sexual exploitation. Section II provides an overview of the various substantive theories of liability and defenses, as well as special procedural difficulties and problems of proof in sexual abuse cases. It suggests that the "consent" defense is an inappropriate analytical framework in a malpractice action based upon therapist sexual exploitation. The real dispute should center around the parameters of a therapist's duty to his patient outside of the formal therapeutic setting. Section III examines the statute of limitations problem, and suggests …