Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Law and Society (17)
- Legislation (16)
- Medicine and Health Sciences (14)
- Public Health (13)
- Torts (11)
-
- Civil Law (10)
- Comparative and Foreign Law (8)
- Bioethics and Medical Ethics (3)
- Administrative Law (2)
- Criminal Law (2)
- Food and Drug Law (2)
- Science and Technology Law (2)
- Family Law (1)
- Health and Medical Administration (1)
- Insurance Law (1)
- Internet Law (1)
- Law and Gender (1)
- Law and Politics (1)
- Legal Ethics and Professional Responsibility (1)
- Legal Profession (1)
- File Type
Articles 1 - 20 of 20
Full-Text Articles in Medical Jurisprudence
Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski
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
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 …
Medical Malpractice Reform Measures And Their Effects, Robert Leflar
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 …
"Unnatural Deaths," Criminal Sanctions, And Medical Quality Improvement In Japan, Robert B. Leflar
"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 …
Lessons From Personhood’S Defeat: Abortion Restrictions And Side Effects On Women’S Health, Maya Manian
Lessons From Personhood’S Defeat: Abortion Restrictions And Side Effects On Women’S Health, Maya Manian
Maya Manian
State personhood laws pose a puzzle. These laws would establish fertilized eggs as persons and, by doing so, would ban all abortions. Many states have consistently supported laws restricting abortion care. Yet, thus far no personhood laws have passed. Why? This Article offers a possible explanation and draws lessons from that explanation for understanding and resisting abortion restrictions more broadly. I suggest that voters’ recognition of the implications of personhood legislation for health issues other than abortion may have led to personhood’s defeat. In other words, opponents of personhood proposals appear to have successfully reconnected abortion to pregnancy care, contraception, …
Reform Of The United States Health Care System: An Overview, Robert B. Leflar
Reform Of The United States Health Care System: An Overview, Robert B. Leflar
Robert B Leflar
This essay, written for readers unfamiliar with the details of American health law and policy, portrays the essential features of the battle for health reform in the United States and of the law that survived the battle: the Patient Protection and Affordable Care Act (PPACA). The essay summarizes key aspects of the U.S. health care system and how it compares in terms of costs and results with other advanced nations’ systems. The political and legal conflicts leading up to and following PPACA’s enactment are described. The major features of the law, attempting to address problems of access to health care, …
Reform Of The United States Health Care System: An Overview, Robert B. Leflar
Reform Of The United States Health Care System: An Overview, Robert B. Leflar
Robert B Leflar
This essay, written for readers unfamiliar with the details of American health law and policy, portrays the essential features of the battle for health reform in the United States and of the law that survived the battle: the Patient Protection and Affordable Care Act (PPACA). The essay summarizes key aspects of the U.S. health care system and how it compares in terms of costs and results with other advanced nations’systems. The political and legal conflicts leading up to and following PPACA’s enactment are described. The major features of the law, attempting to address problems of access to health care, quality, …
The Law Of Medical Misadventure In Japan, Robert B. Leflar
The Law Of Medical Misadventure In Japan, Robert B. Leflar
Robert B Leflar
This paper offers a comprehensive overview of Japanese law and practice relating to iatrogenic (medically-caused) injury, with comparisons to other nations’ medical law systems. The paper addresses criminal sanctions for Japanese physicians’ negligent and illegal acts; civil law principles of substantive law and related issues of procedure, practice, and liability insurance; and administrative measures including health ministry programs aimed at expanding and improving the quality of peer review within Japanese medicine, and a recently implemented no-fault compensation system for birth-related injuries. Among the paper’s findings are these. Criminal and civil actions increased rapidly after highly publicized medical error events at …
Public And Private Justice: Redressing Health Care Harm In Japan, Robert B. Leflar
Public And Private Justice: Redressing Health Care Harm In Japan, Robert B. Leflar
Robert B Leflar
Japanese legal structures addressing health care-related deaths and injuries rely more on public law institutions and rules than do the common-law North American jurisdictions, where private law adjudication is predominant. This article explores four developments in 21st-century Japanese health care law. The first two are in the public law sphere: criminal prosecutions of health care personnel accused of medical errors, and a health ministry-sponsored “Model Project” to analyze medical-practice-associated deaths. The article addresses a private law innovation: health care divisions of trial courts in several metropolitan areas. Finally, the article introduces Japan’s new no-fault program for compensating birth-related obstetrical injuries. …
Medical Malpractice (Book Review), Robert B. Leflar
Medical Malpractice (Book Review), Robert B. Leflar
Robert B Leflar
This is a review of Medical Malpractice, by Frank Sloan and Lindsey Chepke. This superb book provides a balanced, comprehensive, factual overview of the structure, flaws, and merits of the U.S. legal system relating to malpractice; the causes of cyclical insurance pricing and availability difficulties; ameliorative initiatives both implemented and proposed; and the political considerations affecting the achievability of leading reform proposals. The authors' evidence-based stances will discommode many participants in the malpractice debate, physicians and trial lawyers alike. The book debunks widely-held "myths of medical malpractice" propounded by medical tort reformers. However, the authors also conclude that "no convincing …
Reasons To Pass Health Reform, Robert B. Leflar, Hershey Garner Md
Reasons To Pass Health Reform, Robert B. Leflar, Hershey Garner Md
Robert B Leflar
Column 5 (of 5) on the health reform debate
Health Reform: Arkansas Impacts, Robert B. Leflar
Health Reform: Arkansas Impacts, Robert B. Leflar
Robert B Leflar
Column 4 (of 5) on the health reform debate
Medical Malpractice Reform?, Robert B. Leflar
Medical Malpractice Reform?, Robert B. Leflar
Robert B Leflar
Column 3 (of 5) on health reform: Medical malpractice reform proposals
Health Bills: What's At The Core, Robert B. Leflar
Health Bills: What's At The Core, Robert B. Leflar
Robert B Leflar
Column 2 (of 5) on the health reform debate: explanation of the legislation.
Health Care: Yellow Lights, Red Flags, Robert B. Leflar
Health Care: Yellow Lights, Red Flags, Robert B. Leflar
Robert B Leflar
Column 1 (of 5) on the health reform debate
The Regulation Of Medical Malpractice In Japan, Robert Leflar
The Regulation Of Medical Malpractice In Japan, Robert Leflar
Robert B Leflar
How Japanese legal and social institutions handle medical errors is little known outside Japan. For almost all of the 20th century, a paternalistic paradigm prevailed. Characteristics of the legal environment affecting Japanese medicine included few attorneys handling medical cases, low litigation rates, long delays, predictable damage awards, and low-cost malpractice insurance. However, transparency principles have gained traction and public concern over medical errors has intensified. Recent legal developments include courts' adoption of a less deferential standard of informed consent; increases in the numbers of malpractice claims and of practicing attorneys; more efficient claims handling by specialist judges and speedier trials; …
Medical Error As Reportable Event, As Tort, As Crime: A Transpacific Comparison, Robert B. Leflar, Futoshi Iwata
Medical Error As Reportable Event, As Tort, As Crime: A Transpacific Comparison, Robert B. Leflar, Futoshi Iwata
Robert B Leflar
All nations seek to reduce the human toll from medical error, but variations in legal and institutional structures guide those efforts into different trajectories. This article compares legal and institutional responses to patient safety problems in the United States and Japan, addressing developments in civil malpractice law (including discoverability of internal hospital documents), administrative practice (including medical accident reporting systems), and - of particular significance in Japan - criminal law. In the U.S., battles over rules of malpractice litigation are fierce; tort law occupies center stage. The hospital accreditation process plays a critical role in medical quality control, and peer …
Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar
Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar
Robert B Leflar
Japan is on a steeper trajectory toward the incorporation of informed consent principles into medical practice than the “gradual transformation” observed in a 1996 article, Informed Consent and Patients’ Rights in Japan. Among the most significant recent developments from 1996 to 2001 have been these seven: (1) the 1997 enactment of the Organ Transplantation Law permitting the use of brain death criteria in limited circumstances in which informed consent is present; (2) the strengthening of patients’ rights in clinical drug trials; (3) the continued trend toward increasing disclosure to patients of cancer diagnoses; (4) initiatives by the health ministry toward …
Informed Consent And Patients' Rights In Japan, Robert B. Leflar
Informed Consent And Patients' Rights In Japan, Robert B. Leflar
Robert B Leflar
This article analyzes the development of the concept of informed consent in the context of the culture and economics of Japanese medicine, and locates that development within the framework of the nation's civil law system. Part II sketches the cultural foundations of medical paternalism in Japan; explores the economic incentives (many of them administratively directed) that have sustained physicians' traditional dominant roles; and describes the judiciary's hesitancy to challenge physicians' professional discretion. Part III delineates the forces testing the paternalist model: the undermining of the physicians' personal knowledge of their patients that accompanies the shift from neighborhood clinic to high-tech …
Public Accountability And Medical Device Regulation, Robert B. Leflar
Public Accountability And Medical Device Regulation, Robert B. Leflar
Robert B Leflar
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …