Medical Jurisprudence Commons^™

Introduction, Thomas L. Shaffer

Thomas L. Shaffer

No abstract provided.

Professional Employee Or Supervisory Employee: Are Nurses Protected By The Nlra? An Analysis Of Nlrb V. Health Care & Retirement Corp., Barbara J. Fick

Barbara J. Fick

This article previews the Supreme Court case NLRB v. Health Care and Retirement Corp. of America, 511 U.S. 571 (1994). The National Labor Relations Act protects employees' right to unionize and their actions aimed at improving working conditions. The Act does not, however, protect supervisory employees on the premise that employers deserve the undivided loyalty of their agents. In this case, the Court is asked to decide if nurses who direct the work of aides and orderlies are employees protected from discharge in their efforts to improve working conditions, or are supervisors who can be fired for such conduct.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Natural Rights Of Children, Walter E. Block

Walter E Block

No abstract provided.

"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell

Frederick Mark Gedicks

Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …

Public Assistance, Drug Testing And The Law: The Limits Of Population-Based Legal Analysis, Candice Player

Candice T Player

In Populations, Public Health and the Law, legal scholar Wendy Parmet urges courts to embrace population-based legal analysis, a public health inspired approach to legal reasoning. Parmet contends that population-based legal analysis offers a way to analyze legal issues—not unlike law and economics—as well as a set of values from which to critique contemporary legal discourse. Population-based analysis has been warmly embraced by the health law community as a bold new way of analyzing legal issues. Still population-based analysis is not without its problems. At times Parmet claims too much territory for the population-perspective. Moreover Parmet urges courts to recognize …

The Dangerousness Of The Status Quo: A Case For Modernizing Civil Commitment Law, Daniel A. Moon

Daniel C Moon

The states, private healthcare organizations, and those with psychiatric disorders are poorly served by the vague “dangerousness” standard endorsed by the United States Supreme Court in O’Connor v. Donaldson, as well as the state statutes that adhere to the high bar set in its holding. This paper explores involuntary civil commitment from a variety of perspectives in order to highlight these issues and to identify where improvements can be made. Specifically, this article proposes that the American Law Institute or the American Bar Association promulgate model rules intended to correct the system’s shortcomings and protect the various interested parties.

Life And Death Decision-Making: Judges V. Legislators As Sources Of Law In Bioethics, Charles Baron

Charles H. Baron

In some situations, courts may be better sources of new law than legislatures. Some support for this proposition is provided by the performance of American courts in the development of law regarding the “right to die.” When confronted with the problems presented by mid-Twentieth Century technological advances in prolonging human life, American legislators were slow to act. It was the state common law courts, beginning with Quinlan in 1976, that took primary responsibility for gradually crafting new legal principles that excepted withdrawal of life-prolonging treatment from the application of general laws dealing with homicide and suicide. These courts, like the …

The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles Baron

Charles H. Baron

No abstract provided.

Licensure Of Health Care Professionals: The Consumer's Case For Abolition, Charles H. Baron

Charles H. Baron

While state medical licensure laws ostensibly are intended to promote worthwhile goals, such as the maintenance of high standards in health care delivery, this Article argues that these laws in practice are detrimental to consumers. The Article takes the position that licensure contributes to high medical care costs and stifles competition, innovation and consumer autonomy. It concludes that delicensure would expand the range of health services available to consumers and reduce patient dependency, and that these developments would tend to make medical practice more satisfying to consumers and providers of health care services.

The Concept Of Person In The Law, Charles Baron

Charles H. Baron

The focus of the abortion debate in the United States tends to be on whether and at what stage a fetus is a person. I believe this tendency has been unfortunate and counterproductive. Instead of advancing dialogue between opposing sides, such a focus seems to have stunted it, leaving advocates in the sort of “I did not!” – “You did too!” impasse we remember from childhood. Also reminiscent of that childhood scene has been the vain attempt to break the impasse by appeal to a higher authority. Thus, the pro-choice forces hoped they had proved the pro-life forces “wrong” by …

A Model State Act To Authorize And Regulate Physician-Assisted Suicide, Charles H. Baron, Clyde Bergstresser, Dan W. Brock, Garrick F. Cole, Nancy S. Dorfman, Judith A. Johnson, Lowell E. Schnipper, James Vorenberg, Sidney H. Wanzer

Charles H. Baron

Despite laws in many states prohibiting assisted suicide, an unknown but significant number of people each year commit suicide with the aid of a physician. In recent years, the phenomenon of physician-assisted suicide has attracted greater attention as physicians have openly risked prosecution to shed light on the subject, advocates have raised a series of legal challenges to laws banning assisted suicide, and a federal judge has struck down the nation's first statute allowing physicians to assist patients in suicide. In this Article, nine authors from the fields of law, medicine, philosophy and economics propose a comprehensive statute to permit …

Medical Paternalism And The Rule Of Law: A Reply To Dr. Relman, Charles Baron

Charles H. Baron

In this Article, Professor Baron challenges the position taken recently by Dr. Arnold Relman in this journal that the 1977 Saikewicz decision of the Supreme Judicial Court of Massachusetts was incorrect in calling for routine judicial resolution of decisions whether to provide life-prolonging treatment to terminally ill incompetent patients. First, Professor Baron argues that Dr. Relman's position that doctors should make such decisions is based upon an outmoded, paternalistic view of the doctor-patient relationship. Second, he points out the importance of guaranteeing to such decisions the special qualities of process which characterize decision making by courts and which are not …

Fetal Research: The Question In The States, Charles H. Baron

Charles H. Baron

This article is based on a paper delivered at the Third National Symposium on Genetics and the Law in Boston, April 1984.

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Consentimiento Informado: Un Derecho Fundamental En La Relación Médico Paciente., Guillermo Castorena

Guillermo Castorena

Este derecho está basado en el principio de autonomía. Se trata de un derecho humano del paciente, aunque por otra parte, podría verse también como un elemento estructural esencial del contrato de servicios médicos, esto es, la esencia misma de ese acto médico-jurídico. De esa manera, la voluntad del paciente para someterse a un procedimiento médico o quirúrgico con fines diagnósticos, terapéuticos, rehabilitatorios o paliativos, se formará por un proceso de información, entendimiento, razonamiento y manifestación de la voluntad.

Medical Malpractice Reform Measures And Their Effects, Robert Leflar

Robert B Leflar

New rules and methods for medical injury dispute resolution have been launched in New Hampshire and New York, and demonstration projects are underway elsewhere. This article describes major medical malpractice reforms undertaken and proposed in recent years. Reforms are classified as (1) liability-limiting initiatives favoring health-care providers; (2) procedural innovations promoted as improving dispute resolution processes, such as patient compensation funds, “sorry” laws, disclosure and early offer laws, health courts, and safe harbor laws; and (3) major conceptual reforms to move liability away from physicians to hospitals or administrative no-fault compensation systems. Empirical evidence about the practical effects of already-implemented …

The Issue Is Being Intersex: The Current Standard Of Care Is A Result Of Ignorance, And It Is Amazing What A Little Analysis Can Conclude., Marla J. Ferguson

marla j ferguson

The Constitution was written to protect and empower all citizens of the United States, including those who are born with Disorders of Sex Development. The medical community, as a whole, is not equipped with the knowledge required to adequately diagnose or treat intersex babies. Intersex simply means that the baby is born with both male and female genitalia. The current method that doctors follow is to choose a sex to assign the baby, and preform irreversible surgery on them without informed consent. Ultimately the intersex babies are mutilated and robbed of many of their fundamental rights; most notably, the right …

Perkinelmer Inc. V. Intema Ltd. And Patent-Eligibility Of Diagnostic Screening Methods After Mayo V. Prometheus, John Ye

John Ye

In December 2011, the Supreme Court issued its ruling in Mayo v. Prometheus,[1] reversing the Federal Circuit based on unpatentable subject matter in a diagnostic method patent. In Mayo, the patent disclosed a method for determining the correct drug dosage based on the drug’s metabolite in a patient’s blood. The method was declared patent-ineligible because instead of teaching an application of laws of nature, the teachings only directed doctors to “apply it” - all disguised under the conventional steps such as “administering”, “measuring” and “determining” [2].

Following the Court’s holding, the Federal Circuit in November 2012 …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Association Between Work-Family Conflict And Musculoskeletal Pain Among Hospital Patient Care Workers, Seung-Sup Kim, Cassandra Okechukwu, Orfeu Buxton, Jack Dennerlein, Leslie Boden, Dean Hashimoto, Glorian Sorenson

Dean M. Hashimoto

Background

A growing body of evidence suggests that work–family conflict is an important risk factor for workers' health and well-being. The goal of this study is to examine association between work–family conflict and musculoskeletal pain among hospital patient care workers.

Methods

We analyzed a cross-sectional survey of 1,119 hospital patient care workers in 105 units in two urban, academic hospitals. Work–family conflict was measured by 5-item Work–Family Conflict Scale questionnaire. Multilevel logistic regression was applied to examine associations between work–family conflict and self-reported musculoskeletal pain in the past 3 months, adjusting for covariates including work-related psychosocial factors and physical work …

"Unnatural Deaths," Criminal Sanctions, And Medical Quality Improvement In Japan, Robert B. Leflar

Robert B Leflar

A worldwide awakening to the high incidence of preventable harm resulting from medical care, combined with pressure on hospitals and physicians from liability litigation, has turned international attention to the need for better structures to resolve medical disputes in a way that promotes medical safety and honesty toward patients. The civil justice system in the United States, in particular, is criticized as inefficient, arbitrary, and sometimes punitive. It is charged with undermining sound medical care by encouraging wasteful expenditures through defensive medicine; by driving information about medical mistakes underground where it escapes analysis, undercutting quality improvement efforts; and by forcing …

Loss Of Chance, Probabilistic Cause, And Damage Calculations: The Error In Matsuyama V. Birnbaum And The Majority Rule Of Damages In Many Jurisdictions More Generally, Robert J. Rhee

Robert Rhee

This short commentary corrects an erroneous understanding of probabilistic causation in the loss-of-chance doctrine and the damage calculation method adopted in Matsuyama v. Birnbaum. The Supreme Judicial Court of Massachusetts is not alone. Many other common law courts have made the same error, including Indiana, Nevada, New Mexico, Ohio, and Oklahoma. The consistency in the mistake suggests that the error is the majority rule of damages. I demonstrate here that this majority rule is based on erroneous mathematical reasoning and the fallacy of probabilistic logic.

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Pirates Of The Australian Election, Matthew Rimmer

Matthew Rimmer

“Pirate parties” have proliferated across Europe and North America in the past decade, championing issues such as intellectual property (IP), freedom of speech, and the protection of privacy and anonymity.This year, the movement hit Australian shores: The Pirate Party Australia was officially registered by the Australian Electoral Commission in January 2013. (You can read its principles and platform here.)“More than ever before, there is a necessity in Australia for a party that holds empowerment, participation, free culture and openness as its central tenets”, Pirate Party founder Rodney Serkowski said in a press release announcing the group’s successful registration. Their first …