Medicine and Health Sciences Commons^™

Reducing Harm: The Legal Viability Of Supervised Consumption Sites In Georgia, Kathleen Kassa

Georgia State University Law Review

Every five minutes in the United States, someone dies from a drug overdose. This public health crisis, referred to as the opioid epidemic, caused the federal government and many states and localities to issue public health emergency declarations. Despite billions of dollars in funding and response at every level of government, overdoses continue to increase.

The complexity of addiction prevention and treatment, socioeconomic inequalities, and the stigmatization of drug use make the opioid crisis difficult to solve. The severity of the epidemic led many jurisdictions to adopt once-controversial harm reduction approaches aimed at reducing the stigma and negative impacts of …

Torts: Covid-19 Pandemic Business Safety Act & Executive Order By The Governor Designating Auxiliary Management Workers And Emergency Management Activities, Angelena Velaj, Troy Viger

Georgia State University Law Review

The Executive Order expanded immunity from liability for volunteer health care workers as emergency management workers performing emergency management activities. The Order was not limited to only COVID-19-related activities. When the legislature reconvened, legislators passed the Georgia COVID-19 Pandemic Business Safety Act, which provided liability limitation to businesses against tort claims arising from the pandemic.

Preemption: Executive Order By The Governor To Ensure A Safe & Healthy Georgia, Marisa P. Ahlzadeh, Fanny Chac

Georgia State University Law Review

The doctrine of preemption expresses the idea that “a higher authority of law will displace a lower authority of law when the two authorities come into conflict.” Preemption exists on both the federal and state level. According to the Georgia Constitution, local laws are permissible if they do not conflict with the state law on the subject. During a Public Health State of Emergency, the Governor of Georgia maintains certain expanded powers to take necessary action for the health and safety of the public. On April 2, 2020, Governor Brian Kemp (R) used these expanded powers to enact an Executive …

Health Insurance Portability And Accountability Act Of 1996: Health & Public Welfare, Erin L. Hayes, Kathryn A. Vance

Georgia State University Law Review

The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) establish a standard for the use and protection of individuals’ health information and apply to certain covered entities or their business associates. Covered entities may only disclose an individual’s protected health information in limited situations. Covered entities or individuals that fail to comply with the Privacy Rule standards may be subject to civil or criminal penalties.

Bioethics: Ethical Considerations Of Ventilator Triage During A Pandemic, Susannah J. Gleason, William J. Keegan

Georgia State University Law Review

In the midst of the COVID-19 pandemic, hospitals across the country faced unprecedented volumes of patients seeking treatment related to the respiratory complications of the virus. As a result, states were forced to reassess existing scarce resource allocation guidelines to appropriately accommodate the high demand. This Peach Sheet analyzes the ethical considerations implicated in enacting and following these guidelines when treating patients, specifically in the context of ventilator triage in response to the COVID-19 pandemic.

First Amendment: Executive Order By The Governor Limiting Large Gatherings Statewide, Alex N. Estroff, Boris W. Gautier

Georgia State University Law Review

Beginning in March 2020, Georgia Governor Brian Kemp (R) issued a series of Executive Orders addressing the State’s response to the COVID-19 pandemic. Included in these Orders was a prohibition on large groups of people gathering in a single location. Though an effective means of curtailing the virus’s rapid transmission, this specific provision became a source of controversy for groups who believed such a prohibition infringed upon their First Amendment rights.

Public Health State Of Emergency: Executive Order By The Governor Declaring A Public Health State Of Emergency, Rebecca Hu, Ellen Y. Min

Georgia State University Law Review

The Executive Order primarily functions to enumerate the Governor’s emergency powers during a Public Health State of Emergency. The Executive Order allows for the Governor to assist health and emergency management officials by deploying available resources for the mitigation and treatment of COVID-19 within Georgia.

Forced Business Closures: Executive Orders By The Governor Closing Private Businesses, Baylee A. Culverhouse, Alexa R. Martin

Georgia State University Law Review

Governor Brian Kemp (R) issued Executive Orders in response to the COVID-19 pandemic that required businesses to close in an effort to limit the spread of the virus. Business owners often challenged those forced business closures as unconstitutional or as exceeding the State’s police power, and those challenges were met with varying degrees of success.

Crimes And Offenses: Proposed Constitutional Carry Act Of 2019 & Executive Order By The Governor Temporarily Extending Renewal Requirements For Weapons Carry Licenses, Kristin Harripaul, Briana A. James

Georgia State University Law Review

In March 2020, Governor Brian Kemp (R) issued an Executive Order declaring a Public Health State of Emergency due to COVID-19. The Supreme Court of Georgia also issued a Judicial Order declaring a Statewide Judicial Emergency. The Council of Probate Court Judges subsequently characterized the processing of weapons carry licenses as non-essential and temporarily suspended license issuances to limit the spread of COVID-19. HB 2 would have eliminated the license requirement and the need for probate judges to process applications. However, HB 2 never received a hearing before the 2019–20 legislative session ended. Gun rights advocates called on Governor Kemp …

Elections: Elections And Primaries Through The Pandemic, Joseph M. Brickman, Logan D. Kirkes

Georgia State University Law Review

The 2020 election cycle was all but normal. Due to certain health concerns associated with the COVID-19 pandemic, Georgia delayed its primary election three months from March to June and summarily mailed absentee ballot request forms to all active, registered voters. From presidential social media postings to a federal lawsuit, debate ensued over the widespread usage of absentee ballots, their overall effectiveness and security, who would receive request forms, and whether postage requirements qualified as an impermissible poll tax. To further compound these uncertainties, Georgia legislators, who are not permitted to fundraise or campaign during the forty-day legislative session, had …

Mandatory Quarantine: Administrative Order By The Georgia Department Of Public Health For Public Health Control Measures: Isolation Protocol, Matthew C. Daigle, Carissa L. Lavin

Georgia State University Law Review

The Administrative Order for Public Health Control Measures and its subsequent amendments outlined the Isolation and Quarantine Protocols for individuals who either tested positive for COVID-19 or were suspected of COVID-19 infection based on symptoms or prolonged exposure to the virus.

Medical-Legal Collaboration And Community Partnerships: Prioritizing Prevention Of Human Trafficking In Federally Qualified Health Centers, Kimberly S.G. Chang Md, Mph, Hamida Yusufzai, Anna Marjavi

Georgia State University Law Review

Human trafficking (HT) is increasingly recognized as a public health issue, and its severe consequences affect some of society’s most vulnerable members. Prioritizing prevention is a critical component of a public health framework when addressing HT, and the health care delivery system plays a crucial role in operationalizing primary, secondary, and tertiary prevention interventions. As a significant part of the primary care system in the U.S., Federally Qualified Health Centers (FQHCs) are uniquely positioned to be the first point of contact with the health care system for people at risk for and affected by HT. FQHCs provide many preventive services, …

Understanding Risk And Prevention In Midwestern Antitrafficking Efforts: Service Providers' Perspectives, Hannah E. Britton Ph.D.

Georgia State University Law Review

Since the 2000 passage of both the Trafficking Victims Protection Act (TVPA) and the U.N.’s Palermo Protocols, human trafficking has gained a notable global presence as a human rights concern. Community organizations, nonprofits, scholars, policymakers, and service providers have developed programs to identify and address human trafficking. Despite these efforts, finding reliable methods to document and quantify the instances of human trafficking continues to challenge researchers. Moreover, many believe trafficking is a problem primarily located in urban areas or along national borders.

Drawing from seven years of interviews with service providers who work in this sector, combined with survey results …

Hospital Mergers And Public Accountability: Tennessee And Virginia Employ A Certificate Of Public Advantage, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Faculty Publications By Year

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

The Double-Edged Sword Of Health Care Integration: Consolidation And Cost Control, Erin C. Fuse Brown, Jaime S. King

Faculty Publications By Year

The average family of four in the United States spends $25,826 per year on health care. American health care costs so much because we both overuse and overpay for health care goods and services. The Affordable Care Act's cost control policies focus on curbing overutilization by encouraging health care providers to integrate to promote efficiency and eliminate waste, but the the cost control policies largely ignore prices. This article examines this overlooked half of health care cost control policy: rising prices and the policy levers held by the states to address them. We challenge the conventional wisdom that reducing overutilization …

Resurrecting Health Care Rate Regulation, Erin C. Fuse Brown

Faculty Publications By Year

Our excess health care spending in the United States is driven largely by our high health care prices. Our prices are so high because they are undisciplined by market forces, in a health care system rife with market failures, which include information asymmetries, noncompetitive levels of provider market concentration, moral hazard created by health insurance, multiple principal-agent relationships with misaligned incentives, and externalities from unwarranted price variation and discrimination. These health care market failures invite a regulatory solution. An array of legal and policy solutions are typically advanced to control our health care prices and spending, including: (1) market solutions …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

The Impact Of Disability: A Comparative Approach To Medical Resource Allocation In Public Health Emergencies, Katie Hanschke, Leslie E. Wolf, Wendy F. Hensel

Faculty Publications By Year

It is a matter of time before the next widespread pandemic or natural disaster hits the United States (U.S.). The international response to the 2009 H1N1 influenza stands as a cautionary tale about how prepared the world is for such an emergency. Although the pandemic fortunately proved to be less severe than initially anticipated, it nevertheless resulted in shortages of medical equipment, overburdened hospitals, and preventable patient deaths, particularly among young people.

A pandemic will inevitably lead to difficult decisions about the allocation of medical resources, such as who will have priority access to ventilators and critical care beds when …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

When Harvard Said No To Eugenics: The J. Ewing Mears Bequest, 1927, Paul A. Lombardo

Faculty Publications By Year

James Ewing Mears (1838-1919) was a founding member of the Philadelphia Academy of Surgery. His 1910 book, The Problem of Race Betterment, laid the groundwork for later authors to explore the uses of surgical sterilization as a eugenic measure. Mears left $60,000 in his will to Harvard University to support the teaching of eugenics. Although numerous eugenic activists were on the Harvard faculty, and who of its Presidents were also associated with the eugenics movement, Harvard refused the Mears gift. The bequest was eventually awarded to Jefferson Medical College in Philadelphia. This article explains why Harvard turned its back …

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.