Law Commons^™

The Constitutional Right To Refuse: Roe, Casey, And The Fourteenth Amendment Rights Of Healthcare Providers, Mark L. Rienzi

Mark L Rienzi

The Fourteenth Amendment rights of various parties in the abortion context—the pregnant woman, the fetus, the fetus’ father, the state—have been discussed at length by commentators and the courts. Surprisingly, the Fourteenth Amendment rights of the healthcare provider asked to provide the abortion have not. Roe and Casey establish a pregnant woman’s Fourteenth Amendment right to decide for herself whether to have an abortion. Do those same precedents also protect her doctor’s right to decide whether to participate in abortion procedures?

The Court’s substantive due process analysis typically looks for rights that are “deeply rooted” in our history and traditions. …

Compliance With Advance Directives: Wrongful Living And Tort Law Incentives, Holly Lynch, Michele Mathes, Nadia Sawicki

Nadia N. Sawicki

Modern ethical and legal norms generally require that deference be accorded to patients' decisions regarding treatment, including decisions to refuse life-sustaining care, even when patients no longer have the capacity to communicate those decisions to their physicians. Advance directives were developed as a means by which a patient's autonomy regarding medical care might survive such incapacity. Unfortunately, preserving patient autonomy at the end of life has been no simple task. First, it has been difficult to persuade patients to prepare for incapacity by making their wishes known. Second, even when they have done so, there is a distinct possibility that …

The Hollow Promise Of Freedom Of Conscience, Nadia N. Sawicki

Nadia N. Sawicki

Two hundred years ago, Thomas Jefferson asserted that no law “ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority." Since then, freedom of conscience has continued to be heralded as a fundamental principle of American society. Indeed, many current policy debates – most notably in the medical and military contexts – are predicated on the theory that claims of conscience are worthy of legal respect. This Article challenges established assumptions, concluding that claims about the importance of conscience in American society have been highly exaggerated.

This Article first …

The Abortion Informed Consent Debate: More Light, Less Heat, Nadia N. Sawicki

Nadia N. Sawicki

State abortion informed consent laws – including those requiring physicians to disclose that abortion terminates the life of a “whole, separate, unique, living human being” or display ultrasound images to patients seeking abortions – are being adopted at a rapid pace. Health law scholars who oppose these laws uniformly criticize them as being fundamentally inconsistent with the doctrine of informed consent. This Article directly challenges this conventional approach. It argues that the doctrine of informed consent does not impose nearly as significant a barrier to abortion disclosure laws as many critics claim. Rather, the ethical and legal principles of informed …

The Skinny On The Federal Menu-Labeling Law & Why It Should Survive A First Amendment Challenge, Dayna B. Royal

Dayna B. Royal

In America’s battle of the bulge, the bulge is winning. Contributing to this obesity epidemic is Americans’ increasingly widespread practice of eating at restaurants where deceptively fattening food is served to patrons who grossly underestimate the calories in their meals.

To combat this problem and promote public health, Congress enacted a federal menu-labeling law, which requires that restaurants post calorie information next to menu offerings. The constitutionality of this law has yet to be tested in court. But New York City’s law, enacted prior, has survived First Amendment scrutiny.

Like New York’s menu-labeling law, the federal law should withstand a …

Gene Probes As Unpatentable Printed Matter, Andrew Chin

Andrew Chin

In this Article, I argue that the most problematic kind of gene patents — those claiming short DNA molecules used to probe for longer gene sequences — should be held invalid as directed to unpatentable printed matter. This argument, which emerges from recent developments in biotechnology and information technology, is grounded in the printed matter doctrine’s structural role of obviating patentability inquiries directed to inapposite information-management considerations. Where the inventive contribution in a claimed gene probe subsists solely in stored sequence information, these inapposite considerations lead the novelty and nonobviousness analyses to anomalous results that the printed matter doctrine was …

Decriminalizing Profitable Human Organ Exchange For Organ Sources; Improving Our Nation’S Exchange Paradigm Using The Millian Harm Principle, Zachary C. Meeks

Zachary C Meeks

The National Organ Transplant Act (NOTA) and the Uniform Anatomical Gift Act (UAGA) lack jurisdictional legitimacy in prohibiting a profitable human organ exchange. The primary focus of this note is explaining this lack of legitimacy, not the advocacy of particular forms of profitable exchange. Using John Stuart Mill’s harm principle, I will show why imposing criminal liability for profitable human organ exchange remains outside the scope of legitimate government coercion in a free society. The legislative paternalism of NOTA and UAGA illegitimately restrict the liberty of desperately ill people in procuring a life-saving organ and the liberty of people who …

California's Interest In Schwarzenegger V. Entertainment Merchants Association, Deana Ann Pollard Sacks

Deana A Pollard

The issue pending before the Supreme Court in Schwarzenegger v. Entertainment Merchants Association is whether a California law prohibiting the sale of the most violent “morbid or deviant” video games to minors violates the minors’ First Amendment right to receive the video game “speech.” The manner in which the Ninth Circuit has framed this issue, however, fails to identify fully all of the minors’ First Amendment interests at risk on both sides of the controversy. The most recent and credible scientific evidence concerning the risks that violent video games pose to the mental health of minors has constitutional implications that …

When Patent Rights And Public Health Collide: Going Beyond Compulsory Licensing To Solve The Doha Paragraph 6 Problem, Marcela I. Shirsat

Marcela I Shirsat

It has been almost ten years since the Doha Ministerial Conference’s Declaration on Public Health, however, since that time the developing nation’s access to medicines has not changed. Towards the end of 2001, the Doha Declaration on Public Health (“Doha Declaration”) was meant to alleviate the dissatisfaction with aspects of the TRIPS regime by reaffirming the flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines. However, it raised a concern under paragraph 6 that certain members had either insufficient or no manufacturing capacities in the pharmaceutical sector and therefore could face difficulties in making …

The Trial That Never Happened: Josef Mengele And The Twins Of Auschwitz, Michael A. Grodin M.D., Eva M. Kor, Susan Benedict Dsn

Michael A. Grodin M.D.

This is the first publication in English of a Mock Trial conducted in abstentia of Dr. Joseph Mengele the physician at the Auschwitz Nazi Death Camp. This important historical event documented the Crimes Against Humanity carried out by Dr. Mengele on the Twins of Auschwitz. The testimony was to be used in a International War Crimes Tribunal that never happened.

Nursing The Primary Care Shortage Back To Health: How Expanding Nurse Practitioner Autonomy Can Safely And Economically Meet The Growing Demand For Basic Health Care, Michael B. Zand

Michael B Zand

As well-educated health care professionals, nurse practitioners are strongly positioned to fill the primary care gap created by the decreasing number of general practice physicians. However, due to robust opposition from the medical profession, nurse practitioners are burdened by a state by state patchwork of laws that impede their autonomous practice of medicine. Such barriers include limits on the right to prescribe medications, elaborate requirements to collaborate with physicians, and limits on insurance reimbursement. Although the profession of nurse practitioner only began in the 1960s, at which point physicians had long enjoyed a legal monopoly over the practice of medicine, …

The Benefits Of Opt-In Federalism, Brendan Maher

Brendan Maher

The Affordable Care Act (“ACA”) is a historic and controversial statute that mandates people make insurance bargains. Unacknowledged is an innovative mechanism ACA uses to select the law that governs those bargains: opt-in federalism.

Opt-in federalism -- in which individuals choose between federal and state rules -- is a promising theoretical means to make and choose law. This Article explains why, and concludes that the appeal of opt-in federalism is independent of ACA. Whatever the statute’s constitutional fate, future policymakers should consider opt-in federalist approaches to answer fundamental but exceedingly difficult questions of health and retirement law.

The Medical Device Federal Preemption Trilogy: Salvaging Due Process For Injured Patients, Demetria D. Frank-Jackson

Demetria D Frank-Jackson

Ignoring over a century of tort law precedence, ultimately leaving thousands of people all over the country injured by medical devices without remedy, the prevailing jurisprudence on medical device federal preemption is both current and relevant. Due to the inherent ambiguity of the preemption provision Medical Device Amendments of 1976, where contemporary medical device litigation had its beginnings, the regulatory nature of common law tort claims against medical device manufacturers has been overwhelming called into question. Given this socio-judicial backdrop, the Article focuses on two rapidly developing areas of law: (1) preemption of certain medical device claims following the U.S. …

Conscientious Objection And Pharmacists' Professional Obligation To Ensure Access To Legitimately Prescribed Medication, Andrea N. Lee

Andrea N Lee

This paper discusses legal issues surrounding pharmacists who refuse to dispense emergency contraception based on their religious views. One study reports up to thirty-one percent of pharmacists admit to not dispensing emergency contraception based on their moral or religious beliefs, leading to women’s limited access to a second chance to prevent pregnancy when their regular preventative method fails. Without a limitation on when pharmacists can deny patients access to legitimately prescribed medication, women’s fundamental right to choose whether to bear a child is no longer her choice, but her pharmacist’s choice. Legislatures must require pharmacists to act in their patient’s, …

Flag On The Play: The Ninth Circuit’S End-Run Around Implied Rights Of Action Runs Afoul In County Of Santa Clara V. Astra, Usa Inc., Brooke Burns

Brooke Burns

In County of Santa Clara v. Astra, USA Inc., the Ninth Circuit held that a third party was entitled to bring a private right of action for breach of contract under federal common law, even though the governing statute neither expressly nor impliedly provides for this right. Because the Supreme Court has increasingly limited the ability of a third party to bring an implied right of action claim, private parties have pursued third party beneficiary claims instead. As a result, a considerable circuit split has resulted as to whether federal common law provides a private right of action to a …

Don’T Split The Baby: How The U.S. Could Avoid Uncertainty And Unnecessary Litigation And Promote Equality By Emulating The British Surrogacy Law Regime, Austin R. Caster

Austin R Caster

This article will show that the United States can protect the rights of the intended parents, the surrogate, and the child while avoiding uncertainty and unnecessary litigation by enacting uniform legislation akin to the United Kingdom’s regime. The first section will examine the history of surrogacy law in the United States, demonstrate the inconsistency of these laws, and suggest that reform is needed. Section two will discuss the United Kingdom’s legislative response to the problem of surrogacy arrangements, which has provided more uniformity despite obstacles similar to those faced in the United States. The third section will illustrate that the …

A National Strategy To Combat The Childhood Obesity Epidemic, Lauren B. Kaplin

Lauren Kaplin

Childhood obesity has become a veritable epidemic in the United States: with over a quarter of Americans and seventeen percent of children and adolescents weighing in as obese, obesity has become the most expensive preventable health care cost. Such high incidences of have caused today’s children to be the first generation in American history to have a shorter life expectancy than their parents.

Like in the battle against tobacco use before it, the government has now taken up the fight against childhood obesity, enacting the Healthy, Hunger-Free Kids Act of 2010. By modifying the existing National School Lunch Program to …

Relational Malpractice And The Transformation Of Healthcare Law, Sagit Mor, Orna Rabinovich-Einy

Sagit Mor

Legal scholarship in recent decades has devoted considerable attention to the "malpractice crisis." However, the vast majority of this literature has overlooked the essence of the problem. Mainstream legal writing on malpractice has tended to frame the problem as either an insurance crisis or a litigation crisis. In this article, we offer an alternative understanding of the nature of the current malpractice predicament: the decline of the doctor-patient relationship. We highlight the fact that contemporary doctor-patient interactions resemble a battle zone: a majority of physicians view "every patient as a potential malpractice lawsuit," while patients complain that their physicians are …

When Is Medical Care “Futile”? The Institutional Competence Of The Medical Profession Regarding The Provision Of Life-Sustaining Medical Care, Meir Katz

Meir Katz

“Medical futility,” the doctrine by which hospital ethics boards have assumed the right to authorize medical providers to unilaterally withdraw or decline to provide aggressive life sustaining medical care, has swelled in popularity in recent years and has affected the lives of countless terminal patients. The case law governing medical futility is inconsistent and appears to provide medical providers and patients alike little guidance in this extremely sensitive area of health law. Lost in the confusion created by the case and statutory law is due consideration of the normative case behind “medical futility.” “Futility,” by definition, is preceded by an …

Vaccine Liability In The Supreme Court: Forging A Social Compact, John D. Kraemer, Lawrence O. Gostin

John D Kraemer

In its decision in Bruesewitz v. Wyeth LLC, the Supreme Court ruled that state products liability suits that allege design defects in vaccines are preempted by the National Childhood Vaccine Injury Act. This decision, the third in a trilogy of Supreme Court preemption cases that deal with products liability suits for health commodities, preserves the Vaccine Injury Compensation Program and the delicate balance between ensuring the vaccine supply and compensating injuries that it enables. Failing to preempt state product liability suits would have exposed vaccine manufacturers to substantial litigation costs defending unfounded claims about autism.

Disputes Related To Healthcare Across National Boundaries: The Potential For Arbitration, Deth Sao

Deth Sao

Trade in international health services has the potential to play a leading role in the global economy, but its rapid growth is impeded by legal barriers. Advances in technology and cross-border movement of people and health services create legal ambiguities and uncertainties for businesses and consumers involved in transnational medical malpractice disputes. Existing legal protections and remedies afforded by traditional judicial frameworks are unable to resolve the following challenges: (1) assertion of personal jurisdiction; (2) choice of forum and law considerations; (3) appropriate theories of liability for injuries and damages arising from innovations in medical care and delivery of health …

Is The Attorney-Client Privilege A Privilege Of The Rich? Federal Hmis Database Reporting And Homeless Client Confidentiality, Jennifer Hammitt

Jennifer Hammitt

No abstract provided.

Fda Oversight Of Autologous Stem Cell Therapies: Legitimate Regulation Of Drugs And Devices Or Groundless Interference With The Practice Of Medicine?, Mary Ann Chirba, Stephanie M. Garfield

Mary Ann Chirba

No abstract provided.

Due Process In Civil Commitments, Alexander Tsesis

Alexander Tsesis

In one of its most controversial decisions to date, United States v. Comstock, the Roberts Court upheld a federal civil commitment statute requiring only an intermediate burden of proof. The statute provided for the postsentencing confinement of anyone proven by “clear and convincing evidence” to be mentally ill and dangerous. The law relied on a judicial standard established more than thirty years before. The majority in Comstock missed the opportunity to reassess the precedent in light of recent psychiatric studies indicating that the ambiguity of available diagnostic tools can lead to erroneous insanity assessments and mistaken evaluations about patients’ likelihood …

Drug User Fees, Health Priorities, Politics, The Deficit And Reform Directions, Margaret Gilhooley

Margaret Gilhooley

The Food and Drug Administration now depends on user fees paid by drug companies to support more than half the salaries of the medical reviewers who advise the agency on the appropriateness of approving the drug. The funding creates a substantial risk of "capture" of the agency by the industry. Under the program,which started in 1992, drug companies pay a fee that permits the agency to hire additional reviewers to make more timely reviews on whether a drug can be approved. Under the law the agency seeks to meet performance goals for the timing of reviews, giving the program the …

Somebody's Watching Me: Protecting Patient Privacy In De-Identified Prescription Health Information, Christopher R. Smith

Christopher R Smith

Increasingly, legal scholars, state legislatures and the federal courts are examining patient privacy concerns that arise in the context of the dissemination, distribution and use of patient prescription information. However, less attention has been paid to the sharing of de-identified or encrypted patient prescription information versus identifiable patient prescription information. Though many patients may not realize it, identifiable, de-identified and encrypted patient prescription information is being used for a host of purposes other than insurance reimbursement and treatment, most notably for pharmaceutical marketing purposes. Existing state and federal laws and ethical guidelines provide some protection for the privacy of patient …

Moving Upstream: The Merits Of A Public Health Law Approach To Human Trafficking, Jonathan Todres

Jonathan Todres

Human trafficking, a gross violation of human rights and human dignity, has been identified by numerous government leaders as one of the priority issues of our time. Legislative efforts over the past decade have produced a patchwork of criminal laws and some assistance programs for victims. There is no evidence, however, that these efforts have reduced the incidence of trafficking. This lack of meaningful progress prompts questions as to what the best framework is for addressing human trafficking. This Article begins with a discussion of the limitations inherent in the current law-enforcement-centric approach to the problem. It then explores the …