Health Law and Policy Commons^™

A Graceful Exit: Redefining Terminal To Expand The Availability Of Physician-Facilitated Suicide, Browne C. Lewis

Law Faculty Articles and Essays

For almost ten years, Oregon stood alone as the state that permits terminally ill persons to choose the time and manner of their deaths. Finally, in 2009, Oregon received company when the state of Washington’s physician facilitated suicide statute officially went into effect in March of that year. Supporters of the statutes hailed the enactments as a victory for persons seeking to die with dignity. Persons from groups like Compassion & Choices vowed to seek similar legislation in the remaining states. Representatives from the Washington State Medical Association, hospice groups and hospitals argued that the mandates of the statutes place …

Application Of Default Rules To Address Financial Conflicts Of Interest In Academic Medical Centers, Joanna K. Sax

Indiana Law Journal

This Essay proposes that the rules governing financial conflicts of interest for scientists within the National Institutes of Health apply to scientists at Academic Medical Centers because scientists at both places receive federal funding. The rules governing financial conflicts of interest within the National Institutes of Health are stricter than the rules at Academic Medical Centers. The cornerstone of financial conflicts of interest rules at Academic Medical Centers is disclosure, which is inadequate. This Essay builds on previous work calling for significant changes to rules addressing financial conflicts of interest, and it promotes changes by calling for the application of …

Bridging The Great Divide—A Response To Linda Greenhouse And Reva B. Siegel's "Before (And After) Roe V. Wade: New Questions About Backlash", Lolita Buckner Inniss

Law Faculty Articles and Essays

This essay discusses the history of Roe v. Wade as recently addressed by Linda Greenhouse and Reva B. Siegel. Going beyond their assertions, I suggest that an additional, more encompassing inquiry focuses on what factors are implicated in the politics of abortion and how these factors relate to larger social, political, and cultural conflicts both before and after Roe. By naming party politics and the Catholic Church, Greenhouse and Siegel posit two crucial elements that shaped the abortion debate. I assert, however, that what is not discussed in their Article is the way numerous other factors have figured into the …

Adopting Accountable Care Through The Medicare Framework, Barbara Zabawa, Louise G. Trubek, Felice Borisey-Rudin

Faculty Works

The Patient Protection and Affordable Care Act of 2010 (PPACA) attempts to provoke change in the status quo in American health care delivery and payment. PPACA created two programs, the Medicare Shared Savings Program (MSSP) and the Pioneer ACO model, which work to bring the concept of Accountable Care Organizations (ACOs) to the Medicare program. At its core, accountable care matches payment for care with performance-based measures, a bold move away from current volume-based models. The paper makes the case that the Medicare-based programs serve as a suitable launch pad for the accountable care movement. The paper explores the emergence …

Comparative Pragmatism, Rachel Rebouché

UF Law Faculty Publications

Although several commentators have previously suggested that the United States and Germany now share more commonalities than differences, this Article challenges the conventional wisdom by suggesting that the United States and Germany have moved in the opposite direction on a spectrum of available abortion services. In the United States, the constitutional right to an abortion is unrealizable for many women due to restrictive state and federal laws and the absence of providers in many areas. In Germany, by contrast, despite the country’s formal recognition of fetal rights, early abortion is widely available and often funded by the government. In short, …

Never Say Never: "Never Events" In Medicare, John Crist

Health Matrix: The Journal of Law-Medicine

No abstract provided.

International Trademark Protection And Global Public Health: A Just-Compensation Regime For Expropriations And Regulatory Takings, Sam Foster Halabi

Catholic University Law Review

No abstract provided.

Good Intentions, Bad Consequences: How Congress’S Efforts To Eradicate Hiv/Aids Stifle The Speech Of Humanitarian Organizations, Garima Malhotra

Catholic University Law Review

No abstract provided.

A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson

Faculty Scholarship

The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.

The Politics Of Medicaid, Nicole Huberfeld

Faculty Scholarship

Medicaid is the word on everyone's lips, not only because of the budgetary crisis many states are suffering, but also because the Supreme Court will decide two major cases regarding Medicaid this term, each of which has the potential to significantly alter the course of this long-standing safety net as well as the constitutional principles undergirding the program. Medicaid is a federal program that was intended to mainstream the very poor into the healthcare system by providing states with matching federal funds for particular expenditures on and provision of medical care. Without Medicaid, tens of millions of Americans would be …

The Affordable Care Act Individual Coverage Requirement: Ways To Frame The Commerce Clause Issue, Wendy K. Mariner

Faculty Scholarship

No abstract provided.

With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich

Faculty Scholarship

In Doe v. Division of Youth & Family Services , a hospital employee sought state intervention when an HIV-positive woman refused to comply with treatment recommendations during her pregnancy to drastically reduce the chances of mother-to-child-transmission (MTCT), eventually triggering a lawsuit against the hospital. With an increase in the number of HIV-positive women becoming pregnant and the court avoiding constitutional analysis of the woman’s right to refuse medical treatment, there is a clear void where legal analysis is surely needed. This Article fills this void for the inevitable case where an HIV-positive pregnant woman’s right to refuse medical treatment is …

Regulating Compounding Pharmacies After Necc, Kevin Outterson

Faculty Scholarship

Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.

Deductions For Drug Ads? The Constitution Does Not Require Congress To Subsidize Direct-To-Consumer Prescription Drug Advertisements, Shoshana Speiser, Kevin Outterson

Faculty Scholarship

The First Amendment protects lawful, non-misleading advertising as commercial speech, which constrains Congressional attempts to regulate direct-to-consumer advertising (DTCA) of prescription drugs. But the Constitution does not require the federal government to subsidize advertising through the Tax Code. Congress could revoke the legislative gift of tax deductions for DTCA without running afoul of regulating speech. While DTCA proponents maintain that DTCA increases disease awareness and leads to more doctor-patient conversations, Congress could find that these purported benefits are outweighed by other negative consequences, including excessive prescribing.

All Pain, No Gain: Need For Prudent Antimicrobial Use Provisions To Complement The Gain Act, Kevin Outterson

Faculty Scholarship

Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial stewardship incentives in the GAIN Act, which is a serious error in the long-term struggle with pathogenic microbes.

Pleading As Information-Forcing, Alexander Reinert

Articles

Academics, judges, and practitioners have devoted much attention to the potential impact of the federal pleading standards announced in Ashcroft v. Iqbal, 556 U.S. 662 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Many have criticized Iqbal and Twombly on procedural, substantive, and policy grounds. And although most everyone agrees that the cases mark a break with past liberal pleading rules and have changed pleading practice, there is little agreement about precisely how the cases have affected ultimate outcomes. Indeed, there is much confusion about what exactly the new rules require of a pleader.

In this Article, …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

Harm Reduction, Human Rights, And Access To Information On Safer Abortion, Joanna Erdman

Articles, Book Chapters, & Popular Press

A harm reduction and human rights approach, grounded in the principles of neutrality, humanism, and pragmatism, supports women's access to information on the safer self-use of misoprostol in diverse legal settings. Neutrality refers to a focus on the risks and harms of abortion rather than its legal or moral status. Humanism refers to the entitlement of all women to care and concern for their lives and health, to be treated with respect, worth, and dignity, and to the empowerment of women to participate in decision-making and political action. Pragmatism accepts the historical reality that women will engage in unsafe abortion, …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

Substitute Decision-Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study. We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …