Health Law and Policy Commons^™

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

Just What The Doctor Ordered? How The Patient Safety And Quality Improvement Act May Cure Florida’S Patients’ Right To Know About Adverse Medical Incidents (Amendment 7), Kelly G. Dunberg

Florida Law Review

This Note addresses the impact of Florida’s Patients’ Right to Know About Adverse Medical Incidents (commonly known as Amendment 7) on the peer review process and the quality of healthcare in Florida. Enacted in 2004 as an amendment to the Florida Constitution, Amendment 7 provides citizens access to records and reports of past adverse medical incidents involving doctors, hospitals, and healthcare providers. Critics of Amendment 7 argue that peer review privilege protections are necessary to maintain high-quality healthcare in Florida, pointing to the need to encourage candid and vigorous evaluations by physicians of their colleagues. In contrast, Amendment 7 supporters …

Misappropriating Women’S History In The Law And Politics Of Abortion , Tracy A. Thomas

Seattle University Law Review

To examine the veracity of the political and legal claims of a feminist history against abortion, this Article focuses on one of the leading icons used in antiabortion advocacy—Elizabeth Cady Stanton. Stanton has, quite literally, been the poster child for FFL’s historical campaign against abortion, appearing on posters, flyers, and commemorative coffee mugs. Advocates claim that Stanton is a particularly fitting spokesperson because she was a “feisty gal who had seven children and was outspokenly pro-life.” They claim that she “condemned abortion in the strongest possible terms” and was “a revolutionary who consistently advocated for the rights of women, for …

Investing In Health Care: What Happens When Physicians Invest And Why The Recent Changes To The Patient Protection And Affordable Care Act Fail To Protect Patients From Their Physicians’ Self-Interest, Nancy L. Zisk

Seattle University Law Review

This Article considers possible ways to protect a patient’s interest in receiving care and advice that reflects solely what is in the patient’s best interest and not what might be in the interest of his or her physician’s financial health. Part II reviews the importance of trust in the physician–patient relationship and examines how that relationship is affected by the conflict of interest that arises between patients and their physicians who own the medical facilities, devices, and treatment services prescribed. Part III examines the ethical and statutory restrictions that have been and are currently imposed on physicians who own facilities …

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

The Patient Protection And Affordable Care Act: Why It Is Important For Women’S Health, Mary Fanning

Journal of Interdisciplinary Feminist Thought

President Barack Obama signed into law the Patient Protection and Affordable Care Act (ACA) on March 23, 2010 ending the long history of disparity in access to health care services between insured and uninsured persons. Disparity between women and men in obtaining health insurance coverage is also corrected in the act. Women’s organizations that have focused attention on women’s distinctive health needs over the past century and a half laid the foundation for provisions in the legislation that address women’s health. This article addresses health insurance coverage, its impact on health, the particular challenges women have confronted in seeking coverage, …

The Calculus Of Accommodation: Contraception, Abortion, Same-Sex Marriage, And Other Clashes Between Religion And The State, Robin F. Wilson

Scholarly Articles

This Article considers a burning issue in society today— whether, and under what circumstances, religious groups and individuals should be exempted from the dictates of civil law. The “political maelstrom” over the Obama administration’s sterilization and contraceptive coverage mandate is just one of many clashes between religion and the state. Religious groups and individuals have also sought religious exemptions to the duty to assist with abortions or facilitate samesex marriages. In all these contexts, religious objectors claim a special right of entitlement to follow their religious tenets, in the face of equally compelling claims that religious accommodations threaten access and …

Health Law Outlook - Volume 6, Issue 1 (Fall 2012)

Health Law Outlook (archive)

Inside this issue:

• Multi Drug-Resistant TB and Extensive Drug-Resistant TB: Regulating the Growing Crisis, Phil DeFedele
• From School to the 'Real World': Transition Rights for Students with Special Needs, Kristine Kodytek
• Government Tokophobia: Unjustly Denying Pregnant Women Access to Research, Joel Silver
• Criminalizing Prenatal Substance Abuse: Hurting Women and Their Unborn Children, Sara Smith
• Everyone Wants a Piece of Me: The Evolution of Biospecimen Research and the Regulatory World's Attempt to Keep Up, Isabel Heine
• Complications of Globalization: FDA Cracks Down on Fraud in the Pharmaceutical Industry, Clarissa Gomez
• Medical Malpractice Apology Law: "Don't …

Abandoning Women To Their Rights: What Happens When Feminist Jurisprudence Ignores Birthing Rights, Rebecca A. Spence

Student Articles and Papers

The goals of the Article are twofold. First, this Article will demonstrate that while birthing rights issues have been familiar areas of concern for feminist scholarship on women's rights to privacy and equality, neglecting to integrate this work into the law school classroom fails to promote effective legal advocacy for pregnant women. The violation of women's rights during childbirth is a more common problem than reported legal opinions indicate, and few lawyers are prepared to protect clients prospectively or to vindicate women's rights post-childbirth.

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that …

Rethinking Hiv-Exposure Crimes, Margo Kaplan

Indiana Law Journal

This Article challenges the current legislative and scholarly approaches to HIV-exposure crimes and proposes an alternative framework to address their flaws. Twenty-four states criminalize consensual sexual activities of people with HIV. Current statutes and the scholarship that supports them focus on HIV-positive status, sexual activity, and knowledge of HIV-positive status as proxies for risk, mental state, and consent to risk. As a result, they are dramatically over- and underinclusive and stigmatize individuals living with HIV. Criminalization should be limited to circumstances in which a defendant exposed her partner to a substantial degree of unassumed risk and did so with a …

Family Law—Egg Donation And Stem Cell Research—Eggs For Sale: The Scrambled State Of Legislation In The Human Egg Market, Kitty L. Cone

University of Arkansas at Little Rock Law Review

Rapid expansion of technology in medicine over the last few decades has both enhanced our lives and complicated our laws. For example, thanks to advances in science and medicine, couples who were previously unable to reproduce are now able to do so with the help of donors, medical personnel, and a host of other middlemen facilitating the process. The growth of medical technology has also lead to the advent of using human eggs for medical research. However, despite competing for eggs from a small pool of willing donors, there is a disparity in the law between the treatment of human …

Health Insurance And Federalism-In-Fact, Radha A. Pathak, Brendan S. Maher

Faculty Scholarship

The constitutional legitimacy of the Patient Protection and Affordable Care Act (“ACA”) received substantial attention. Less examined has been the legislation’s sub-constitutional effect on the regulatory power that states can and might exercise. Regarding a state's ability to promulgate "sickness rules," (those legal rules pertaining to the conditions or treatment an insurance policy covers) and "non-sickness" rules (those legal rules pertaining to insurance other than sickness rules), we scrutinize the ACA itself and contrast it with the other most significant statute governing private health insurance, the Employee Retirement Income Security Act of 1974 (“ERISA”). The authors would like to thank …

Virginia's "War On Women": How Forcing Women To Have An Ultrasound Before Abortion Is Unconstitutional, Alison B. Linas

Law Student Publications

This comment will discuss how the ultrasound bill, like similar ones in other states, is unconstitutional for two reasons....Part II of this comment will focus on the Supreme Court's role in shaping abortion policy....Part III will describe Virginia’s new ultrasound requirement and how the above-mentioned Supreme Court decisions affect the new bill’s legality. Part III(A) will lay out the relevant portions of the bill and discuss its legislative history. Part III(B) will analyze the bill through Casey’s undue burden lens....Part III(C) will argue that requiring a woman to have a mandatory medical procedure effectively prevents her from refusing medical care, …

Dispatch From The Culture War: Virginia's Failed Hpv Vaccination Mandate, Rachel Reynolds

Law Student Publications

This paper will inquire into what makes Gardasil different from other vaccines, and how that impacts its administration. Part I will describe the specifics of the HPV vaccine: how it works and how Virginia decided to promote its usage. Part II will examine the ways in which jurisdictions have traditionally understood vaccination policy, and contrast it with the ways in which they have handled the HPV vaccine. Part III will examine the disadvantages of continuing the mandate’s ineffective political war of attrition, and suggest a coalition-building strategy to effect policy that honors communal values and meaningfully increases access to the …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Comparativist-Structural Approaches To Interpretation Of The Post-Obamacare Spending Power, Michelle Biddulph, Dwight G. Newman

Cardozo Journal of International and Comparative Law

The U.S. Supreme Court's decision on the Affordable Care Act (ACA) has significant implications for the federal spending power, a topic that has received limited scholarly attention. The article argues that understanding this aspect of the ACA ruling is crucial for comprehending its impact on future federal programs and legislative approaches. By examining the spending power frameworks in Canada and Australia, the article highlights how different federal systems balance central authority with regional autonomy, offering valuable lessons for the U.S. legal framework.

Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins

Faculty Publications

Congress paid nearly no attention to the Constitution when enacting the Affordable Care Act (ACA) in 2010. Legislative hearings and committee reports ignored the Constitution altogether; legislative debates largely did the same. This Essay both highlights Congress’s indifference to the Constitution when enacting the ACA and examines the reasons behind this legislative failure. In particular, this Essay advances three explanations. First, Congress is generally uninterested in “public goods” like constitutional interpretation. Second, the polarization of Democrats and Republicans in Congress further depresses Congress’s interest in thinking about the Constitution; instead, the majority party seeks to limit opportunities for the minority …

The Past And Future Of Deinstitutionalization Litigation, Samuel R. Bagenstos

Cardozo Law Review

Two conflicting stories have consumed the academic debate regarding the impact of deinstitutionalization litigation. The first, which has risen almost to the level of conventional wisdom, is that deinstitutionalization was a disaster. The second story challenges the suggestion that deinstitutionalization has uniformly been unsuccessful, as well as the causal link critics seek to draw with the growth of the homeless population. This Article, which embraces the second story, assesses the current wave of deinstitutionalization litigation. It contends that things will be different this time. The particular outcomes of the first wave of deinstitutionalization litigation, this Article contends, resulted from the …

Community Health Workers: A Front Line For Primary Care?, Lisa Sprague

National Health Policy Forum

Among the potential changes invoked in discussions on health system transformation, a need to revitalize primary care remains paramount. One way of doing this, most agree, is to move more in the direction of team-based care. Professionals such as physician assistants and nurse practitioners may be able to ease some of the physician’s clinical care load, but some populations also need help accessing services and basic health education in a familiar setting. Enter the community health worker (CHW), known by many titles and playing a variety of roles, who comes from the community he or she is serving and therefore …