Law Commons^™

Liberty Without Capacity: Why States Should Ban Adolescent Driving, Vivian E. Hamilton

Faculty Publications

No abstract provided.

Contract Law—No Faith In Arkansas’S Approach To The Implied Duty Of Good Faith. Arkansas Research Medical Testing, Llc V. Osborne, 2011 Ark. 158, 2011 Wl 1423993., Kathleen Lestage

University of Arkansas at Little Rock Law Review

No abstract provided.

Paternalism, Public Health, And Behavioral Economics: A Problematic Combination, Wendy K. Mariner

Faculty Scholarship

Some critiques of public health regulations assume that measures directed at industry should be considered paternalistic whenever they limit any consumer choices. Given the presumption against paternalistic measures, this conception of paternalism puts government proposals to regulate industry to the same stringent proof as clearly paternalist proposals to directly regulate individuals for their own benefit. The result is to discourage regulating industry in ways that protect the public from harm and instead to encourage regulating individuals for their own good -- quite the opposite of what one would expect from a rejection of paternalism. Arguments favoring "soft paternalism" to justify …

Themes, Doctrine, And Pedagogy In The 2013-2014 National Health Law Moot Court Competition Problem, Anita Bernstein

Faculty Scholarship

No abstract provided.

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Diane Hoffmann

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Virginia Rowthorn

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

Breastfeeding And A New Type Of Employment Law, Marcy Karin, Robin Runge

Catholic University Law Review

No abstract provided.

Not All Women Are Mothers: Addressing The Invisibility Of Women Under The Control Of The Criminal Justice System Who Do Not Have Children, Venezia Michalsen, Jeanne Flavin

Department of Justice Studies Faculty Scholarship and Creative Works

Research has consistently shown that most women under the control of the criminal justice system are mothers. The robustness of this finding has been accompanied by a failure to consider the characteristics and needs of women without children. In this study, we examine data on 1,334 formerly incarcerated women. Findings indicate that while mothers and non-mothers share some characteristics, they differ on several others, most notably demographic profile, mental health, and timing of contacts with the criminal justice system. These results suggest a need to recognize the diversity among women offender groups, particularly when developing policies and programs need.

Global Rules For Global Health: Why We Need An Independent, Impartial Who, Devi Sridhar, Julio Frenk, Lawrence O. Gostin, Suerie Moon

Georgetown Law Faculty Publications and Other Works

Over the past few years the World Health Organization (WHO) has been undergoing a significant reform process. The immediate trigger was a budget crisis in 2010 that spurred massive lay-offs at the global agency. But at a more fundamental level, deeper systematic changes in global health governance have made reform imperative. While WHO reform draws relatively little attention outside diplomatic circles in Geneva, at stake are critical issues that will impact public health everywhere. This article’s key messages are:

• Recent outbreaks of MERS highlight the need for a global response to infectious disease
• The WHO has had a crucial role …

The Medicaid Gamble, Ann Marie Marciarille

Faculty Works

The Patient Protection and Affordable Care Act (ACA) was an unprecedented gamble. The ACA transformed Medicaid from an unevenly and underfunded program for the poor and disabled to a program to offer those priced out of commercial insurance markets government-funded health insurance similar to Medicare, the single-payer system for seniors and the disabled. In a sense, the ACA gambled that Medicaid could be more like Medicare.

The ACA, as it was transformed by the Supreme Court of the United States, became a gamble on the part of the Court that good things would follow from empowering each of the states …

Health Care Reform: Colorectal Cancer Screening Disparities, Before And After The Affordable Care Act (Aca), Michael Preston

Michael Preston

Colorectal Cancer is the third most common cancer found in men and women in the United states. In 2014, the American Cancer Society estimates over 142,000 new cases of colorectal cancer and approximately 50,000 deaths. Although the overall death rate for colorectal cancer has decreased over the past 20 years, disparities remain among medically underserved populations.

Hiding The Statute In Plain View: University Of Texas Southwestern Medical Center V. Nassar, Michael J. Zimmer

Nevada Law Journal

No abstract provided.

Limiting What We Can Eat: A Bridge Too Far?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Innovative mayors across America are seeking to shape personal decisions about diet and physical activity, taking a page from tobacco control. But attempts to limit personal choices of what to eat have drawn the ire of vocal critics and sometimes the rebuke of judges, with former New York City mayor Michael Bloomberg’s limit on soda portions becoming a key flash point. The public broadly accepts state power to control infectious diseases, but often draws a line at limiting dietary choices. The author wants to dispel some of the well-worn arguments in the obesity wars.

Multipolarity, Intellectual Property, And The Internationalization Of Public Health Law, Sam F. Halabi

Michigan Journal of International Law

The cause of global health today is arguably the most influential human rights movement ever seen, mobilizing vast flows of direct and indirect aid to the developing world to fight disease and build health care infrastructure; prompting the establishment of international organizations like UNAIDS and the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund); including global health as a priority in major diplomatic summits; and driving the formation and implementation of international agreements to address global health threats. Champions of this movement claim that the diverse and influential state and non-state actors participating in the development of the …

Private Certifiers And Deputies In American Health Care, Frank Pasquale

Faculty Scholarship

No abstract provided.

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

Informed Consent, Psychotropic Medications, And A Prescribing Physician's Duty To Disclose Safer Alternative Treatments, Rita F. Barnett

Rita Barnett-Rose

The use of psychotropic medication to treat any presumed mental health disorder always involves serious risks of harm. Accordingly, before prescribing psychotropic medication to control the behaviors associated with a presumed mental health disorder, prescribing physicians are required, under various medical ethical guidelines and informed consent laws, to first disclose information regarding available alternative treatment options, and the risks and benefits of such alternative treatment options. Indeed, because psychotropic medications are themselves experimental treatments due to the concededly unknown etiology of most mental health disorders, disclosing safer alternative treatments would seem to be a particularly critical aspect of a prescribing …

Administrative Channeling Under The Medicare Act Clarified: Illinois Council, Section 45(H), And The Application Of Congressional Intent, John Aloysius Cogan Jr., Rodney A. Johnson

John Aloysius Cogan Jr.

Mr. Cogan and Mr. Johnson discuss the judicial review provisions of the Medicare Act, codified at 42 U.S.C. section 405(g) and (h), and the Supreme Court cases including Illinois Council that interpret the scope of the "arising under" language. They also examine the history of section 205(h) of the Social Security Act, including the most recent amendment contained in the Deficit Reduction Act of 1984. The relationship between 205(h), DEFRA, and section 405(h) is explored as well as the caselaw addressing and applying section 405(h) in light of Congress' 1984 amendments.

The Legality Of Delaying Key Elements Of The Aca., Nicholas Bagley

Articles

Under the Affordable Care Act (ACA), the employer mandate — the requirement that most employers offer health insurance to their workers or pay a tax penalty — was scheduled to go into effect on January 1, 2014. Last summer, however, the Obama administration announced that it was delaying the mandate for a year. The administration has now extended the delay for midsize firms until 2016.

The Affordable Care Act’S Impact On The Practice Of Occupational Medicine And The Implications For Public Health Surveillance, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.

Transformations In Health Law Practice: The Interections Of Changes In Healthcare And Legal Workplaces, Louise G. Trubek, Barbara J. Zabawa, Paula Galowitz

Louise G Trubek

The passage and implementation of the Affordable Care Act is propelling transformations in health care. The transformations include integration of clinics and hospitals, value based care, patient centeredness, transparency, computerized business models and universal coverage. These shifts are influencing the practice of health law, a vibrant specialty field considered a “hot” area for new lawyers. The paper examines how the transformations in health care are intersecting with ongoing trends in law practice: increase in in-house positions, collaboration between medical and legal professionals, and the continued search for increased access to legal representation for ordinary people. Three health law workplace sites …

Building A Better Laboratory: The Federal Role In Promoting Health System Experimentation, Kristin Madison

Pepperdine Law Review

While expanding federal involvement in the health care system, the Patient Protection and Affordable Care Act (ACA) preserves states' roles as policy laboratories and private providers' roles as health care delivery laboratories. State-based and provider-based laboratories suffer from many shortcomings, however, as mechanisms to develop, evaluate, and facilitate diffusion of reforms within the health system. This Article argues that the federal government can take steps to address these shortcomings. It first briefly reviews ACA provisions that promote policy and delivery experimentation. It then suggests that by tying funding to policy outcomes, making use of regulatory variation and regulatory menus, and …

La Tutela Y Sus Alternativas: Un Manual Sobre La Ley De Maryland, Virginia Rowthorn, Ellen Callegary

Virginia Rowthorn

This is a Spanish language edition of the 2011 edition of Guardianship and Its Alternatives: a Handbook on Maryland Law edited by Virginia Rowthorn and Ellen Callegary available at: http://digitalcommons.law.umaryland.edu/fac_pubs/1163

Navigating The Law Of Defense Counsel Ex Parte Interviews Of Treating Physicians, Joe Regalia, Drew Cass

Joe Regalia

The rising costs of litigation have hit those involved in healthcare-related cases — including patients, doctors, the courts and lawyers — perhaps hardest of all. Litigation costs have triggered rising malpractice insurance rates for doctors, extensive risk for malpractice attorneys on both sides of the aisle, clogged dockets for courts, and rising fees for clients. Not surprisingly, there is a constant debate about ways that litigation costs in these cases might be reduced. One practice that may alleviate at least some of this waste would cost nothing to implement and has the potential to create large savings: allowing ex parte …

Court Of Appeals Of New York - Catholic Charities Of The Diocese Of Albany V. Serio, Sarah Marx

Touro Law Review

No abstract provided.

Ockham's Scalpel: A Return To A Reasonableness Standard, Ellen Wertheimer

Ellen Wertheimer

No abstract provided.

Paying For Prescribed Drugs In Medicaid: Current Policy And Upcoming Changes, Brian K. Bruen, Katherine Young

Health Policy and Management Issue Briefs

Since the early 2000s, state Medicaid programs have made concerted efforts to control the cost of prescription drug spending. One crucial aspect in doing so is using a pharmacy reimbursement methodology that best reflects actual drug costs. Currently, states set pharmacy reimbursement policy within broad federal guidelines, resulting in a complex mix of reimbursement rules. Many states use list prices to set reimbursement levels, and these list prices increasingly have been criticized as not accurately reflecting the cost of the drug. Specifically, there are concerns that some benchmarks lead to inflated reimbursement levels. As a result, the federal government has …

Abortion And The Constitutional Right (Not) To Procreate, Mary Ziegler

University of Richmond Law Review

No abstract provided.