Health Law and Policy Commons^™

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

A Little Less Regulation: Why Federal Pain Management Laws Are Hurting State Efforts To Combat The Opioid Epidemic, Michael Waldrop

Mitchell Hamline Law Review

No abstract provided.

A New Remedy For Junk Science: Article 11.073 And Texas's Response To The Changing Landscape In The Forensic Sciences., Trevor Rosson

St. Mary's Law Journal

Abstract Forthcoming.

No Appropriation Without Compensation: How Per Se Takings Of Personal Property Check The Power To Regulate Commerce., William Sumner Macdaniel

St. Mary's Law Journal

Abstract Forthcoming.

Pipe(Line) Dreams Post-Denbury Green., Nicholas Laurent, Christopher Oddo

St. Mary's Law Journal

In Denbury Green Pipeline-Texas, LLC v. Texas Rice Land Partners, the Beaumont Court of Appeals articulated the test that should be applied when considering whether the condemnation of private property, which would result favorably for pipeline companies, should be allowed. In Denbury, the Beaumont Court of Appeals balanced the protection of private property rights against the need for true common carrier pipeline companies to condemn private property. The court held that in order to condemn private property, a substantial public interest must exist to justify such condemnation. The Texas Supreme Court, however, reversed the decision of the Beaumont Court of …

Tx Rice V. Denbury., Thomas Alan Zabel

St. Mary's Law Journal

Abstract Forthcoming.

The Limits Of Accessibility Under The Affordable Care Act, Nimrah H. Imam

Scripps Senior Theses

The Patient Protection and Affordable Care Act (ACA) aimed to increase accessibility to medical resources for those previously uninsured. Certainly, the ACA has expanded insurance to millions of Americans, however, the evidence and discourse surrounding health accessibility calls into question why, despite the growth of insured Americans, the increase in health insurance coverage under the ACA has not lead to greater accessibility for low income minorities. I propose that disparities in preventive care, the emergency room, and primary care provider services stand as barriers for low income minorities. Insurance coverage does not necessarily equate to greater accessibility if individuals do …

A Population Health Framework For Teaching Health Law, Robert Gatter

Saint Louis University Law Journal

No abstract provided.

Masthead, Volume 27 (2017)

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Health Matrix, Health Matrix

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Moving Beyond "Wellness Does Not Work", Dennis G. Shea, Dennis Scanlon

Health Matrix: The Journal of Law-Medicine

The article focuses on the worksite wellness program (WWP) made by the employers for maintaining the industrial hygiene and also discusses the challenges faced by the employees in implementing the same in the U.S. Topics discussed include Pennsylvania State University's problematic effort in implementing a WWP.

Caveat Emptor: How The Intersection Of Big Data And Consumer Genomics Exponentially Increases Information Privacy Risks, Katherine Drabiak

Health Matrix: The Journal of Law-Medicine

Our genomic sequence constitutes the most sensitive and personal of information: uniquely identifying us, revealing our propensity to develop certain diseases and conditions, and exposing familial connections of close genetic relatives. Big Data enables consumer-genomics companies to collect, store, and electronically share genomic-sequence data in conjunction with numerous pieces of private health and personal information.

Reproductive Selection Bias, Lauren R. Roth

Health Matrix: The Journal of Law-Medicine

Decades after the advent of assisted reproductive technology ("ART") that allows prospective parents to deselect embryos with grave genetic illnesses—a procedure called preimplantation genetic diagnosis ("PGD")— it remains a tool largely of upper-class whites. I argue that the time has come to focus on closing the access gap in this area of reproductive rights in spite of the current political climate. If reproductive liberty is tied to equality through access to medical procedures, scholars must finally answer the question of what equality requires in a system that permits the use of ARTs. This Article shows how the current system of …

The Prescription For Rising Drug Prices: Competition Or Price Controls?, Joanna Shepherd

Health Matrix: The Journal of Law-Medicine

The article focuses on the implementing of reforms aimed at promoting competition or prohibiting anticompetitive practices in rising drug prices in the U.S.

Weapons Of Mass Hysteria, Faulty Biothreat Predictions, And Their Impact On National (In)Security: A Case-Study Of Smallpox, Barbara Pfeffer Billauer

Health Matrix: The Journal of Law-Medicine

Biothreat projections for pandemic and bioterrorist planning are generated by a straight-forward computational system, rather than scientific evidence.

A Crisis Of Patent Law And Medical Innovation: The Category Of Diagnostic Claims In The Wake Of Ariosa V. Sequenom, Alexa Johnson

Health Matrix: The Journal of Law-Medicine

The article analysis the scope of patent eligibility of diagnostic tests in the U.S. focusing on Ariosa v. Sequenom and Mayo Collaborative Servs. v. Prometheus Labs., Inc. court case.

Food For Thought: Flexible Farm To School Procurement Policies Can Increase Access To Fresh, Healthy School Meals, Lauren Tonti

Health Matrix: The Journal of Law-Medicine

The article focuses on the enactment of farm to school procurement policies for providing students health and its impact in increasing access to fresh, healthy school meals in the U.S.

Caring For The Body And The Soul: Small Businesses Post-Hobby Lobby And Hhs Contraceptive Rule, James Lesinski

Health Matrix: The Journal of Law-Medicine

The article examines the corporate personhood movement and its impact on closely-held corporations and individuals focusing on the U.S. Department of Health and Human Services rule.

Private Right Of Action Jurisprudence In Healthcare Discrimination Cases, Allison M. Tinsey

Law Student Publications

Section 1557 of the Affordable Care Act provides that entities covered by the Act which receive federal funds are prohibited from discriminating on the basis of race, color, national origin, sex, age or disability. But since the provision’s enactment and the U.S. Department of Health and Human Services’ promulgation of a regulation creating a private right of action for alleged discrimination under the Act, courts have disagreed on whether a private right of action exists to enforce Section 1557. This Comment summarizes the courts’ confusion in applying the holding of Alexander v. Sandoval and Chevron deference to the nondiscrimination provision …

“Pay To Prescribe”: A Case For Strengthened Enforced Of The Fcpa In The Global Pharmaceutical Industry In 2017 And Beyond, John T. Jessee Jr.

Law Student Publications

This paper will use recent Foreign Corrupt Practices Act (FCPA) enforcement actions to argue that a revamped and increased enforcement of the FCPA’s anti-bribery provisions in the pharmaceutical industry will be an absolutely critical task in 2017 and beyond, as there is much work to be done in cleaning up the industry. The paper will begin by outlining a brief history of the FCPA and examining its basic enforcement provisions. It will then examine the nature of the pharmaceutical industry’s bribery through a detailed analysis of several recent high profile enforcement cases within the industry. Lastly, the paper will propose …

The Triage And Treatment Of Healthcare Institutions In Distress: How To Involve State Regulators In Healthcare Bankruptcies And Receiverships, Brian P. Stern, Christopher J. Fragomeni

Roger Williams University Law Review

No abstract provided.

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby

All Faculty Scholarship

For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their “bad blood,” …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

All Faculty Scholarship

August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the …

Global Health Security In An Era Of Explosive Pandemic Potential, Lawrence O. Gostin, Ana Ayala

Georgetown Law Faculty Publications and Other Works

Pandemics pose a significant risk to security, economic stability, and development. Annualized expected losses from pandemics are estimated at $60 billion per year. Despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in avoidance of pandemic threats.

We cannot wait or continue with the status quo, in which we pay attention to infectious disease threats only when they are at their peak and then are complacent and remain vulnerable until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of …

Special Issue "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo, Guest Editor

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Editor, "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho, Alexander Rovzar

All Faculty Scholarship

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are …

The English Rule - It Ain't English, And Ought Not Be American., Timothy M. Mulligan

St. Mary's Law Journal

Abstract Forthcoming.

The Demise Of Anti-Panhandling Laws In America., Natie Pilgram Neidig

St. Mary's Law Journal

Abstract Forthcoming.