Law Commons^™

Prosecuting Excessive Pricing Of Pharmaceuticals Under Competition Law: Evolutionary Development, Frederick M. Abbott

Scholarly Publications

Prosecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 …

Child-Proofing Global Public Health In Anticipation Of Emergency, Frederick M. Abbott

Scholarly Publications

No abstract provided.

Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott

Scholarly Publications

The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that maybe achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment …

Severe Brain Injury, Disability, And The Law: Achieving Justice For A Marginalized Population, Megan S. Wright, Nina Varsava, Joel Ramirez, Kyle Edwards, Nathan Guevremont, Tamar Ezer, Joseph Fins

Florida State University Law Review

Thousands of persons with severe brain injury who are minimally conscious or "locked in" are wrongly treated as if they are unconscious. Such individuals are unable to advocate for themselves and are typically segregated from society in hospitals or nursing homes. As a result, they constitute a class of persons who often lack access to adequate medical care, rehabilitation, and assistive devices that could aid them in communication and recovery. While this problem is often approached from a medical or scientific point of view, here we frame it as a legal issue amenable to legal remedies. This Article comprehensively explores …

Big Brother Or Big Pharma: The Lion Fight Over The Surveillance And Promotion Of Pharmaceutical Use In America, Patrick Bailey

Florida State University Law Review

No abstract provided.

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Florida State University Law Review

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines—generally, medicines made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life-threatening diseases are biological medicines. Today, that law is beginning to bear fruit; FDA has begun to approve the first of these duplicates, called “biosimilars,” and the products have begun to enter the marketplace.

We …

Reflections On The Report Of The Un Secretary General’S High Level Panel On Access To Medicines, Frederick M. Abbott

Scholarly Publications

No abstract provided.

Rethinking Body Property, Kara W. Swanson

Florida State University Law Review

Body products, including blood, gametes, and kidneys, are a routine part of contemporary medicine. They are also controversial. There is a strong preference for donated gifts, based on an intuition that gifts are pure, altruistic, and healthy, and that purchased products (commodities) are tainted, exploitative, and dangerous. Law and policy reflect this dichotomy, preventing market exchanges either by declaring body products non-property or banning sales by the supplying body. Yet with growing scarcity leading to injustice in the allocation and harvesting of body products, calls to allow sales have been increasing, motivating proposals to increase supplies by compensating bone marrow …

Overtreatment And Informed Consent: A Fraud-Based Solution To Unwanted And Unnecessary Care, Isaac D. Buck

Florida State University Law Review

According to multiple accounts, the administration of American health care results in as much as $800 billion in wasted spending due largely to the provision of overly expensive, inefficient, and unnecessary services. Beyond inflicting fiscal pain on the nation’s pocketbook, this waste has no clinical benefit—and often results in unnecessary hospital stays, cascading follow-up procedures, and time-wasting inconvenience for American patients. But aside from the mere annoyance of unnecessary care, the administration of overtreatment—that is, unnecessary care in and of itself—causes harm to the patient. Excessive care is deficient care. Unnecessary care risks potential medical error and infection, and often …

Trauma-Informed Co-Parenting: How A Shift In Compulsory Divorce Education To Reflect New Brain Development Research Can Promote Both Parents' And Childrens' Best Interests, Nat Stern, Karen Oehme, Anthony J. Ferraro, Lisa S. Panisch, Mallory Lucier-Greer

Scholarly Publications

No abstract provided.

Improving The Medical Services System's Response To Domestic Violence, Nat Stern, Karen Oehme, Elizabeth Donnelly, Rebecca Melvin

Scholarly Publications

No abstract provided.

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

The Illusion Of Autonomy In Women's Medical Decision-Making, Jamie R. Abrams

Florida State University Law Review

This Article considers why there is not more conflict between women and their doctors in obstetric decision-making. While patients in every other medical context have complete autonomy to refuse treatment against medical advice, elect high-risk courses of action, and prioritize their own interests above any other decision-making metric, childbirth is viewed anomalously because of the duty to the fetus that the state and the doctor owe at birth. Many feminist scholars have analyzed the complex resolution of these conflicts when they arise, particularly when the state threatens to intervene to override the birthing woman’s autonomy.

This Article instead considers the …

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Scholarly Publications

No abstract provided.

The Case For Mandatory Training On Screening For Domestic Violence In The Wake Of The Affordable Care Act, Nat Stern, Karen Oehme

Scholarly Publications

No abstract provided.

The Individual Mandate Tax Penalty, Jeffrey H. Kahn

Scholarly Publications

In 2010, President Obama signed legislation that significantly altered the healthcare and health insurance markets in the United States. An integral part of that reform is the individual mandate, a provision that requires individuals to purchase and maintain healthcare insurance. Failure to maintain such coverage subjects an individual to a tax penalty. The Supreme Court upheld the constitutionality of that provision under Congress’s taxing power.

Despite the Supreme Court upholding the individual mandate, fundamental questions remain. This Article addresses the question of whether the use of a tax penalty to encourage taxpayers to do something that the government desires is …

Advancing An Adaptive Standard Of Strict Scrutiny For Content-Based Commercial Speech Regulation, Nat Stern, Mark Joseph Stern

Scholarly Publications

No abstract provided.

Unheard Voices Of Domestic Violence Victims: A Call To Remedy Physician Neglect, Nat Stern, Karen Oehme, Ember Urbach

Scholarly Publications

No abstract provided.

The Anti-Injunction Act And The Individual Mandate, Steve R. Johnson

Scholarly Publications

The Supreme Court will soon consider challenges to constitutionality of the so-called individual mandate portion of the Patient Protection and Affordable Care Act of 2010 (PPACA). It is important for the nation that the Court render a decision on the merits. This could be derailed, however, were the Court to dispose of the case by holding that the Anti-Injunction Act (AIA) and the Declaratory Judgment Act (DJA) preclude pre-enforcement review. Disposition on those grounds would subject the federal government, states, businesses, and individuals to years of additional uncertainty, inconvenience, and expense.

Fortunately, that threat to resolution on the merits can …

The Operation Of The Individual Mandate, Jeffrey H. Kahn

Scholarly Publications

In this article, Kahn describes the technical operation of omportion portions of the individual healthcare mandate, including the application of the penalty provision. Kahn finds that there are problems with the technical drafting of that provision and that serious gaps and ambiguities abound.

Free Rider: A Justification For Mandatory Medical Insurance Under Health Care Reform?, Jeffrey H. Kahn, Douglas A. Kahn

Scholarly Publications

Section 1501 of the Patient Protection and Affordable Care Act added section 5000A to the Internal Revenue Code to require most individuals in the United States, beginning in the year 2014, to purchase an established minimum level of medical insurance. This requirement, which is enforced by a penalty imposed on those who fail to comply, is sometimes referred to as the “individual mandate.” The individual mandate is one element of a vast change to the provision of medical care that Congress implemented in 2010. The individual mandate has proved to be controversial and has been the subject of a number …

The Kidney Donor Scholarship Act: How College Scholarships Can Provide Financial Incentives For Kidney Donation While Preserving Altruistic Meaning, Jake Linford

Scholarly Publications

No abstract provided.

Reinventing Eugenics: Reproductive Choice And Law Reform After World War Ii, Mary Ziegler

Scholarly Publications

No abstract provided.

Note, Eugenic Feminism: Mental Hygiene, The Women's Movement, And The Campaign For Eugenic Legal Reform, 1900-1935, Mary Ziegler

Scholarly Publications

It is well for every woman, however, to think this matter through and to realize that any women’s movement that is correlated with sterility is doomed to fail and annihilation. What shall it profit us eugenically to have women delve in laboratories, or search the heavens, or rule the nations, if the world is to be peopled by scrubwomen and peasants? – Anna M. Blount, Eugenics, in Woman and the Larger Citizenship, 2847, 2904-05 (Shailer Mathews ed., 1913).

Part I of this article examines the evolution of eugenic thought and policy in the United States between 1880 and 1935, …

Improving The Pharmaceutical Industry:Optimality Inside The Framework Of The Current Legal System Provides Access To Medicines For Hiv/Aids Patients In Sub-Saharan Africa, Gourav N. Mukherjee

Florida State University Journal of Transnational Law & Policy

No abstract provided.

Increasing The Supply Of Organs In Transplantation Through Paired Organ Exchanges, Michael T. Morley

Scholarly Publications

No abstract provided.

Proxy Consent To Organ Donation By Incompetents, Michael T. Morley

Scholarly Publications

No abstract provided.

A Bold Step: What Florida Should Do Concerning The Health Of Its Rural Communities, Licensure, And Telemedicine, Talley L. Kaleko

Florida State University Law Review

No abstract provided.

Dispelling The Negative Myths Of Managed Care: An Analysis Of Anti-Managed Care Legislation And The Quality Of Care Provided By Health Maintenance Organizations, Bruce D. Platt, Lisa D. Stream

Florida State University Law Review

No abstract provided.

Treating The Mentally Disordered Offender: Society's Uncertain, Conflicted, And Changing Views, Thomas L. Hafemeister, John Petrila

Florida State University Law Review

No abstract provided.