Health Law and Policy Commons^™

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Pace Intellectual Property, Sports & Entertainment Law Forum

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

Ftc V. Phoebe Putney And Municipalities As Nongovernments, Peter F. Nascenzi

Northwestern University Law Review

American courts have long struggled with categorizing municipalities. They treat municipalities sometimes as private corporations, sometimes as governmental bodies, and sometimes as something in between. This uncertainty provides a shaky foundation for local government law and hampers its development. Local governments are not sure of their powers, and states are unable to create a comprehensive vision of municipal governance. When federal law is involved, the situation is muddled further.

In FTC v. Phoebe Putney, the Supreme Court’s application of the state action doctrine unnecessarily injected federal antitrust law into the relationship between states and municipalities. The state action doctrine …

Intersections Of Violence Against Women And Health: Implications For Health Law And Policy In Nigeria, Cheluchi Onyemelukwe

William & Mary Journal of Race, Gender, and Social Justice

No abstract provided.

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …

Impeding Access To Quality Patient Care And Patient Rights: How Myriad Genetics' Gene Patents Are Unknowingly Killing Cancer Patients And How To Calm The Ripple Effect, Marisa Noelle Pins

Georgia Journal of Law & Technology

No abstract provided.

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Pepperdine Law Review

Imagine applying for a job, and as part of your application process, your prospective employer asks for a photograph. You, as an eager candidate, comply with the request and, unbeknownst to you, the employer runs your picture through a software program that scans you for any common genetic diseases and that estimates your longevity. Alas, your face indicates that you may die young. No job for you. Although this sounds like science fiction, we may not be that far off from this scenario. In June 2014, scientists from Oxford reported that they have developed a facial recognition program that uses …

Immigration And Disability In The United States And Canada, Mark Weber

College of Law Faculty

Disability arises from the dynamic between people’s physical and mental conditions andthe physical and attitudinal barriers in the environment. Applying this idea aboutdisability to United States and Canadian immigration law draws attention to barriers toentry and eventual citizenship for individuals who have disabilities. Historically, NorthAmerican law excluded many classes of immigrants, including those with intellectualdisabilities, mental illness, physical defects, and conditions likely to cause dependency.Though exclusions for individuals likely to draw excessive public resources and thosewith communicable diseases still exist in Canada and the United States, in recent yearsthe United States permitted legalization for severely disabled undocumented immigrantsalready in the …

Nfib V. Sebelius And The Individual Mandate: Thoughts On The Tax/Regulation Distinction, Kyle D. Logue

Michigan Business & Entrepreneurial Law Review

When Chief Justice John Roberts wrote the opinion of the Court in National Federation of Independent Businesses v. Sebelius (NFIB) explaining the constitutionality of the Affordable Care Act’s (ACA) minimum essential coverage provision (sometimes referred to as the individual mandate), he reasoned that the mandate—or, more precisely, the enforcement provision that accompanied the mandate (the Shared Responsibility Payment or SRP)—could be understood as a tax on the failure to purchase health insurance. According to this view, the enactment of the mandate and its accompanying enforcement provisions fell within Congress’s virtually unlimited power to “lay and collect taxes.” This tax-based interpretation …

The Aca’S New Governing Architecture And Innovative State Delivery System Reform Initiatives, Gwendolyn R. Majette

Law Faculty Presentations and Testimony

No abstract provided.

An Opening For Civil Rights In Health Insurance After The Affordable Care Act, Valarie K. Blake

Scholarly Works

Section 1557, the civil rights provision of the Affordable Care Act (“ACA”), is unmatched in its reach, widely applying race, gender, disability, and age discrimination protections across all areas of healthcare. This Article will explore the value added of a civil rights approach to combating health insurance discrimination when combined with other ACA anti-discrimination efforts that were designed to regulate the health insurance market. It will emphasize the role that section 1557 can play in combatting healthcare disparities and will explore the utility of disparate impact and disparate treatment claims to those cases. Lastly, the Article will posit that two …

Of Mice And Men: On The Seclusion Of Immigration Detainees And Hospital Patients, Stacey A. Tovino

Scholarly Works

With a special focus on federal provisions strictly regulating Medicare-participating hospitals' use of seclusion, this Article uses developments in health law as a lens through which the uses and abuses of seclusion in immigration detention centers might be assessed and through which the standards governing detention centers might be improved. In particular, this Article argues that the unenforceable standards governing seclusion in immigration detention, including the most recent version of ICE's Performance-Based National Detention Standards, were incorrectly modeled on correctional standards developed for use in jails and prisons with respect to convicted criminals. This Article asserts that correctional standards are …

Decisions And Orders Of The Nevada Occupational Safety And Health Review Board: Time To Lift The Veil Of Secrecy, Stephen C. Yohay

Nevada Law Journal

No abstract provided.

Should Medicare Be Allowed To Negotiate Drug Prices?, Michael H. Davis

Law Faculty Articles and Essays

No abstract provided.

Toward A Common Secure Future: Four Global Commissions In The Wake Of Ebola, Lawrence O. Gostin, Oyewale Tomori, Suwit Wibulpolprasert, Ashish K. Jha, Julio Frenk, Suerie Moon, Joy Phumaphi, Peter Piot, Barbara Stocking, Victor J. Dzau, Gabriel M. Leung

Georgetown Law Faculty Publications and Other Works

The world is becoming increasingly vulnerable to pandemics resulting from globalization, urbanization, intense human/animal interchange, and climate change. A series of global health crises have emerged since 2000, ranging from Severe Acute Respiratory Syndrome (SARS) and its phylogenetic cousin Middle East Respiratory Syndrome (MERS), to pandemic Influenza A (H1N1), Ebola, and the ongoing Zika virus epidemic. The Ebola epidemic gave rise to four global commissions proposing a bold new agenda for global health preparedness and response for future infectious disease threats.

Four global commissions reviewing the recent Ebola virus disease epidemic response consistently recommended strengthening national health systems, consolidating and …

Increasing Access To Primary Care Using Np’S: The Framework For An Academic Based Nurse-Managed Center In California, Prabjot (Jodie) Sandhu

Doctor of Nursing Practice (DNP) Projects

The dynamics of health care delivery and the role of health care providers is a changing canvas in the United States. The implementation of the Affordable Care Act (ACA), sets a goal to increase access to health care. The systems that support the ACA are constantly under scrutiny as failing to provide key answers to provider shortage and health care access issues. Nurse Practitioners (NPs) who are recognized by the ACA as a comprehensive part of this revolution are in a unique place to find opportunities to promote increased access to health and primary care services. While NPs in California …

How Are Migrant Health Centers And Their Patients Faring Under The Affordable Care Act?, Jessica Sharac, Rachel Gunsalus, Chi Tran, Peter Shin, Sara Rosenbaum

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Migratory and seasonal agricultural workers (MSAWs) provide essential labor for farming in all its branches in the United States. Between 2.4 and 3 million MSAWs live across the U.S. in every state but are clustered in areas dense with agricultural employment. As a population already susceptible to poor health outcomes because of poverty and work-related health risks, MSAWs depend on community health centers, especially those known as migrant health centers that receive additional migrant funding. Reporting data from a national survey of agricultural workers, as well as findings from analyses of data from the Uniform Data System (UDS) that covers …

Causation In Hepatitis B. Vaccination Litigation In France: Breaking Through Scientific Uncertainty?, Jean-Sebastien Borghetti

Chicago-Kent Law Review

Vaccination against hepatitis B has been available since 1982 and is strongly recommended by most health professionals. In France, the hepatitis B vaccine is very widespread, but it has come under suspicion that it can cause demyelinating diseases such as multiple sclerosis. Several epidemiological studies have been carried out to discover if there is indeed a connection between the hepatitis B vaccination and demyelinating diseases, but no such connection has been established so far. Many cases have nevertheless been brought before French courts, in which plaintiffs argue that they have developed a demyelinating disease due to the hepatitis B vaccination, …

A Yellow Fever Epidemic: A New Global Health Emergency?, Lawrence O. Gostin, Daniel Lucey

Georgetown Law Faculty Publications and Other Works

The worst yellow fever epidemic in Angola since 1986 is rapidly spreading, including the capital, Luanda. In Angola, the epidemic began in December 2015 and the laboratory-confirmed outbreak was reported to the World Health Organization (WHO) on January 21, 2016. Angola has had 2023 suspected cases and 258 deaths as of April 26, 2016. China, the Democratic Republic of Congo, and Kenya also have reported cases arising from infected travelers from Angola. Namibia and Zambia also share a long border with Angola, with considerable population movement between the countries. Similar to other recent epidemics, quick and effective action to stop …

Hospital Chargemaster Insanity: Heeling The Healers, George A. Nation Iii

Pepperdine Law Review

Hospital list prices, contained in something called a chargemaster are insanely high, often running 10 times the amount that hospitals routinely accept as full payment from insurers. Moreover, the relative level of a particular hospital’s chargemaster prices bears no relationship to either the quality of the services the hospital provides or, to the cost of the services provided. The purpose of these fictitious list prices is to serve as a starting point or anchoring point, for negotiations with third-party payers regarding the amount that they will actually pay the hospital for it’s goods and services. Ironically, there is widespread agreement, …

American Hospital Association V. Burwell: Correctly Choosing But Erroneously Applying Judicial Discretion In Mandamus Relief Concerning Agency Noncompliance, Michael L. Labattaglia

Maryland Law Review

No abstract provided.

Paternalism, Self-Governance, And Public Health: The Case Of E-Cigarettes, Wendy E. Parmet

University of Miami Law Review

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws …

Where Healthcare And Policing Converge: How Georgia Law Promotes Evasion Of Financial Responsibility For Indigent Arrestees' And Municipal Inmates' Medical Care, L. Taylor Hamrick

Mercer Law Review

When a law enforcement officer arrests an injured or visibly sick person, the officer typically transports the arrestee directly to a hospital for treatment prior to formal booking in a jail or detention facility. Indeed, convicted inmates, pretrial detainees, and arrestees have a constitutional right to receive necessary medical care while in police custody. However, the United States Supreme Court has distinguished a government's constitutional obligation to provide necessary medical care from a duty to pay for such care.' Instead, the Supreme Court has held that a governmental entity must pay for medical treatment of a person in its custody …

The Relationship Between The Markets For Health Insurance And Medical Malpractice Insurance, W. Kip Viscusi, J. Bradley Karl, Patricia H. Born

Vanderbilt Law School Faculty Publications

This article evaluates the interdependence of medical malpractice insurance markets and health insurance markets. Prior research has addressed the performance of these markets, individually, without specifically quantifying the extent to which they are linked. Increasing levels of health insurance losses could increase the scale of potential malpractice claims, boosting medical malpractice losses, or could embody an improvement in medical care quality, which will reduce malpractice losses. Our results for a state panel data set from 2002 to 2009 demonstrate that health insurance losses are negatively related to medical malpractice insurance losses. An additional dollar of health insurance losses is associated …

Vaccines And Airline Travel: A Federal Role To Protect The Public Health, Christopher Robertson

Faculty Scholarship

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority — especially under the Commerce Clause — to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could …

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Dalia Deak, Kevin Outterson, John H. Powers, Aaron S. Kesselheim

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

State V. Second Jud. Dist. Ct. (Ayden A.), 132 Nev. Adv. Op. 33 (April 28, 2016), Audra Powell

Nevada Supreme Court Summaries

NRS 432B.6075 governs emergency admission of children with emotional disturbances to facilities for their protection, and requires a petition for continuance of admission after an emergency admission within five days of the involuntary placement.[1] Based on N.R.C.P. 6(a), which governs the computing of time for judicial purposes, the Court held that the five day limitation on filing a petition was based on judicial, not calendar, days. The Court granted the State’s petition for a writ of mandamus, directing the district court to vacate its order denying the State’s NRS 432B petition.

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Georgia Journal of Law & Technology

No abstract provided.