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Infectious Disease: Policy, Law, and Regulation
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Commencer à lireLongueur: 299 pages3 heures
- Éditeur:
- American Bar Association
- Sortie:
- Oct 1, 2015
- ISBN:
- 9781634253000
- Format:
- Livre
Description
Infectious Disease Policy Law, and Regulation looks at litigation regarding infection-related illnesses and their compensation. The claim arises from an individual victim who attempts to prove that the cause of their specific infection was the negligent act of an entity that is a “vector” of their type of illness, such as a hospital, surgeon, restaurant or retail marketplace.
Informations sur le livre
Infectious Disease: Policy, Law, and Regulation
Longueur: 299 pages3 heures
Description
Infectious Disease Policy Law, and Regulation looks at litigation regarding infection-related illnesses and their compensation. The claim arises from an individual victim who attempts to prove that the cause of their specific infection was the negligent act of an entity that is a “vector” of their type of illness, such as a hospital, surgeon, restaurant or retail marketplace.
- Éditeur:
- American Bar Association
- Sortie:
- Oct 1, 2015
- ISBN:
- 9781634253000
- Format:
- Livre
À propos de l'auteur
En rapport avec Infectious Disease
Aperçu du livre
Infectious Disease - James T. O'Reilly
INFECTIOUS DISEASE
Policy, Law, and Regulation
INFECTIOUS DISEASE
Policy, Law, and Regulation
JAMES T. O’REILLY AND
VICTORIA WELLS WULSIN, MD
Cover design by Amanda Fry/ABA Publishing.
The materials contained herein represent the opinions of the authors and editors, and should not be construed to be the views or opinions of the law firms or companies with whom such persons are in partnership with, associated with, or employed by, nor of the American Bar Association or the Tort Trial and Insurance Practice Section unless adopted pursuant to the bylaws of the Association.
Nothing contained in this book is to be considered as the rendering of legal advice for specific cases, and readers are responsible for obtaining such advice from their own legal counsel. This book is intended for educational and informational purposes only.
© 2015 American Bar Association. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher. For permission, contact the ABA Copyrights and Contracts Department at copyright@americanbar.org or complete the online request form at http://www.americanbar.org/utility/reprint.html.
Library of Congress Cataloging-in-Publication Data
Library of Congress Cataloging-in-Publication Data is on file with the Library of Congress.
Discounts are available for books ordered in bulk. Special consideration is given to state bars, CLE programs, and other bar-related organizations. Inquire at ABA Publishing, American Bar Association, 321 North Clark Street, Chicago, Illinois 60654-7598.
www.ShopABA.org
TABLE OF CONTENTS
Preface
PART 1
UNDERSTANDING THE BACKGROUND
Chapter 1
Introduction
Chapter 2
Background and History
PART 2
UNDERSTANDING LIABILITY LITIGATION
Chapter 3
Liability Litigation
Chapter 4
Hospital Liabilities: Infection Risks and Hospital Litigation
PART 3
UNDERSTANDING REGULATION
Chapter 5
Constitutional Issues
Chapter 6
Regulatory Systems Affecting Infection Control
Chapter 7
Reporting, Quarantine, and Tracing
Chapter 8
Drugs and Related Products: Responding to Infections
Chapter 9
International Issues on Infectious Disease
PART 4
UNDERSTANDING WORKPLACE AND COMMERCIAL ISSUES
Chapter 10
Infection Conflicts and the Workplace
Chapter 11
Commercial Claims Relating to Infectious Disease
PART 5
UNDERSTANDING THE SCIENCE ISSUES
Chapter 12
The Basic Science of Infections
Chapter 13
How Infections Affect Humans
Conclusion
Appendix I
Appendix II
Appendix III
Table of Cases
Index
This book is dedicated with great respect, admiration and affection to Mary Skelly, M.S., of Dublin, Ireland, for her enthusiastic and persistent efforts to prevent and defeat infection to make this a better world.
PREFACE
When the publisher suggested this text in late 2014, I embraced the project eagerly, as my students in the College of Medicine were awed by those speakers who came to our Public Health Policy class from the Ebola war front lines
in Africa. I recognized that many of my law students who had endured the study of antibiotics regulation in our Food & Drug Law courses would be watching as the industrial effort to scale up clinical trials of Ebola-killing agents reached a crescendo. And like many texts that can be ripped from the headlines,
I realized that the quality and staying power of any book requires a patient transcendence of urgent headlines, going beyond the day’s news into the crucial study of why
and how
questions.
This book could not have been attempted without the diligent sharing of wisdom by a true thought leader and active advocate for global health, Dr. Victoria Wells Wulsin, M.D., Dr.P.H. Vic epitomizes the quality of servant leadership that makes a great positive difference in the world. We all owe her thanks for her fine efforts against HIV and STD infections in Kenya as well as in America. Her chapters of wisdom herein are very insightful. Words do not adequately reflect all that we owe her for her great efforts to live her professional calling, to help save real lives of real children and adults. The people of Kenya and the people of greater Cincinnati join us in admiration for Dr. Wulsin’s many contributions to global public health.
Special thanks are due for the excellent and timely research work of our teammates Kylie Conley, Perry Thompson, Marina Schemmel, and Captain Joseph Jordan of the University of Cincinnati College of Law. Our College of Medicine research team benefited from the diligent work of Aaren Kettelhut, Kristen Carpenter, Parthib Das, and Mahima Venkatesh of our MPH program. Their long hours of effort made this a much better book, and we acknowledge their fine contributions to this project. Our law librarians aided the research immeasurably, and I thank Jim Hart, Mary Jenkins, Laura Dixon Caldwell, and Lauren Morrison.
This is neither the first nor the last book written on infectious disease. We hope that the reader will embrace some of the learnings from this text and build upon them, as we have developed our efforts along the paths trod by others before us. Please take this knowledge and apply it to help our global neighbors.
Comments are welcomed to james.oreilly@uc.edu or joreilly@fuse.net.
Prof. Jim O’Reilly
June 2015
PART 1
Understanding the Background
CHAPTER 1
Introduction
The evolution of law to respond to a societal need is a recurring theme for scholars and legislators alike. No challenge is too big for the rhetorical strength of the legal system: Show us a wrong and we’ll create a prohibition or incentive to solve it!
Infectious disease does not follow that path. It mutates, its diagnosis is muddied, its DNA may adapt, and its host animals or humans will migrate, spreading the illness. Law may be an art form, but the science of pathogenic microbes is definitely more technical and less artistic. So the lawyer must know that the power of persuasive oratory has never moved a single virus.
It is the consequences of infection that law can address: workers’ compensation systems for hospital employees, disability determinations for patients severely impacted by infection, rejection of delivery for commercial shipments of goods that may have been carrying a harmful pathogen, or lawsuits against surgeons who were careless during or after surgical operations.
In both the United States and international systems, regulatory agencies adapt their national systems to the needs of infection-control efforts. Collective protection from illness is the motivating force; compulsion about health protective measures is the means; court deference to the selection of which epidemic to fight with which measure is the norm.
Longer term, the legal remedies for individual proof of causation are going to become more robust with the diminishing cost of DNA analysis. The institution that denies that it could have been the source of this person’s infection will be confronted by experts who hold the sample from the hospital, contrasting its DNA with the DNA of the plaintiff’s serum or blood infection. Compensation that had been denied for lack of causal connection will be available, and the hospital or clinic will be expected to beg legislators to immunize the clinical sources of infection from paying for the harm they have either caused or been associated with
in light of the pathology of infection.
CHAPTER 2
Background and History
2:1 Epidemic Infections in Historical Context
Infection and plague have a very long and remarkable place in human history, back to biblical times and before.¹ The bacterial and viral plagues that infected millions of early residents of our planet have been significantly reduced by modern health measures. Each time a crisis of infection-related deaths arises, as occurred with Ebola in 2014 to 2015, news stories will briefly recount the record of other infectious diseases that had negative consequences. Africa’s terrible losses from Ebola have been just the most recent of centuries of chronicled (as well as unreported) massive infection losses, as diseases from one area have been spread by travelers elsewhere. It is important for modern observers to remember the historical background of infection control, since modern civilizations should learn not to repeat the errors of earlier times.
Sanitation and suppression of the primary vectors of disease, such as mosquitoes and water-contaminant microbes, have been a major source of reduction of infections. The introduction of medicines and vaccines to reduce the harm from infections, and to alleviate pain of the infected persons, has been another major source of harm reduction. And education of consumers and parents on the best means to avoid transmitting an illness has reduced the inadvertent passage of infectious agents within families and communities.
2:2 Military Responses to Control Infection
Many Americans do not know the historic contribution that the U.S. military has made to national protection from infectious diseases. Although for millennia mass movements in military campaigns have had the largest impact on spreading diseases from one area to another, times have changed. Invading armies and navies stormed an opponent’s cities and carried along new infections to populations of persons who had never had any prior exposure, and therefore never had immunities, to these diseases. The bubonic plague chronicles of ancient and medieval times show that the lack of immunities and lack of health protections have resulted in serious existential threats to the population of the invaded cities, a silent attack of fatal illness that could not be resisted by guards outside of wooden or stone city walls.
But the military’s disciplined approach to control of soldiers has shown how breakthroughs in medical and preventive treatment can be beneficial. George Washington ordered a mandatory smallpox inoculation of soldiers in the Continental Army, despite reservations by the Continental Congress.²
There has been a significant role of U.S. military doctors in promoting efforts to reduce infections. Civil War wounds often resulted in death, and in some battlefield medical units, soldiers died more frequently from infection in and around the medical care system than from the bullets themselves. In political history terms, the military experiences led Congress to adopt statutes imposing requirements on infection control within the civilian world. Evolution of infection-related standards and legislation was significantly expedited after the Spanish-American War, when deaths in tropical climates were more often attributed to illness than to the cannon or bullet fire by the Spanish defenders. The public sense of outrage at the high rate of military infection deaths was deepened by investigative journalists who were able to track illness in the chaotic conditions of factories preparing canned foods. After the Spanish-American War, when tropical diseases had killed so many soldiers, U.S. Army Major Walter Reed studied the spread of yellow fever. His commission’s efforts in Panama led to a large reduction in this mosquito-borne illness. As the same lessons were applied in typhoid fever suppression, reductions in Army deaths and illnesses were achieved.³
The number of influenza deaths of troops that had been mobilized to fight in World War I was scandalous. Eventually, an influenza vaccine was developed for the U.S. military to reduce the spread of illness, and it became a civilian standard as well. Infection control during World War II, and subsequently in the tropics during the Vietnam War and in deserts during the Iraq and Afghanistan campaigns, has received an unprecedented hundreds of millions of dollars of government funding within the military medicine budgets, and within the veterans postwar treatment budgets. The civilian sector and the world at large has benefited from these infection-control lessons of wartime exposures.
2:3 History of U.S. Regulatory Efforts to Control Infection
Early statutes dealing with infection focused upon screening immigrants, excluding those with illness from landing in the New World, keeping others in temporary quarantine, and attempting the isolation of those already resident persons who exhibited symptoms of a serious infectious illness.
Landmark legal events in infectious disease control have usually involved court decisions on claims of constitutional liberty, that were asserted in times when the public health system focused on isolation and quarantine.
2:4 Learnings from Early Defenses
Urban outbreaks of disease in the late 19th century, such as the St. Louis cholera outbreak of 1902, like other epidemics, resulted in many deaths that would be considered preventable today. The St. Louis case was worse because the cholera vaccine that was developed on the spot caused even worse outcomes than anyone had expected. The requirements for vaccine testing under the federal Virus-Serum-Toxin Act of 1902 was the response by Congress to the problems that had been associated with certain unsafe injectable vaccines.⁴
State models of infection control exhibited multiple variations. Some states did very well with hygiene and public health efforts, while other states had extremely unfortunate outcomes. After the 1906 adoption of the Pure Food and Drugs Act,⁵ the extensive efforts among federal safety regulators and state counterparts showed how coordinated campaigns against infection could have very positive results. As these new federal laws could reach interstate products, the impetus for vaccine quality increased the national attention to infection-control measures.
Uniformity of sanitation standards and greater cooperative actions among local and state health regulators evolved during the 1930s but were still led by a mixed set of local-level health inspection functions. The evolution of federal disease tracking at today’s Centers for Disease Control and Prevention came out of World War II experiences. By the 1950s, mass immunizations against polio and other illnesses showed the value of centralizing the vaccination standards and the infection response coordination efforts. After the 9/11 crisis of 2001, planning to avoid a potential terrorist attack using biological weapons like anthrax accelerated research and stockpiling of antidote supplies.
2:5 Advances in Recent Decades
The changed science of infection control has made a great impact on the reduction of fatalities and debilitating injuries from viral and microbial causes. Applying better cleaning solutions, following better protocols for the actual cleaning of facilities and clinics, and the availability of better medications have reduced the negative impacts of disease as these measures have reduced the incidence of epidemic outbreaks.
Speed of transmission of an infection is a grave concern to emergency planners around the world. It has been seen that novel infectious diseases can begin anywhere, and outbreaks of zoonotic diseases such as Ebola have occurred everywhere in the world, including AIDS in Africa, bovine spongiform encephalopathy (mad cow disease
) in Britain, hantavirus pulmonary syndrome in the United States, and the Nipah virus in Australia.⁶
Because of the advancing pace of international travel, new human-animal interfaces are occurring in and spreading outward from densely populated areas, such as in the western African nation of Guinea, where the first urban outbreak of Ebola occurred. This change in human interaction with the environment calls for an increase in research studies around zoonotic (animal-borne) diseases and the potential vaccines needed to prevent mass outbreaks.
A need for more research studies on emerging diseases and vaccinations has been at the forefront of epidemic preparedness concerns in the past decade. The development and research of vaccines has been insufficiently addressed in many past epidemics, as well as in their allocation to all countries. While drug companies spend billions of dollars on pharmaceutical research, barely any of this investment goes toward protection of the most likely victims of infectious disease, those in Third World nations. Very little of modern vaccine research is done outside of developed countries. In fact, only around $80 million was spent on the development of a malaria vaccine, even though it was a global infection.⁷ While the Ebola vaccine was created and tested very quickly after the epidemic arose, this was not the first time Ebola had caused deaths in Africa. In fact, two outbreaks had occurred before; one had closed down an entire hospital, after its health-care workers fled their positions. This alone should have stirred research scientists to investigate Ebola vaccines and preventions, but with only remote Third World nations experiencing outbreaks of Ebola, the investment priority was never given to this disease and the costs of developing its vaccine were never expended.⁸
More research on zoonotic and emerging diseases such as Ebola needs to be done in order to prevent the transmission of diseases—between different species as well as human-human transmission—before the zoonotic disease hits urban areas.
2:6 Lessons from Responses to SARS
Why had the Ebola outbreak in western Africa in 2014–2015 been treated differently than the SARS outbreak of 2002–2003 and Middle East respiratory coronavirus (MERS) in 2013? One of the main reasons SARS did not become a bigger epidemic was due to the fast use of the then available influenza research funds that were used to help discover transmission routes, containment models, and diagnostic methods. Without the preexisting networks of influenza surveillance and reference laboratories, the SARS outbreak could have become a global issue.⁹ The 774 deaths from SARS were mostly in Hong Kong and China, before the epidemic was halted in 2004.
The SARS experience highlighted the rapid transborder movement of goods that contained the virus, and the international air traffic of persons who were still in the stages of infection prior to full symptoms. The sacrificing of many millions of chickens reduced the rate of exposure for humans and saved countless lives.
After SARS was revealed as a problem in China, the West-East Gas Pipeline Project—which connects remote areas of China to Xinjiang, an urban city—created a SARS Prevention Leading Team. This team was charged with the responsibilities of keeping health workers safe, aware, and able to respond.¹⁰
While SARS was contained quickly once action was taken to isolate and diagnose symptomatic patients, several things could have been done to prevent more damage. At first, SARS was not quickly distinguished from influenza inside China, and the issue was not accurately and timely reported to China’s public or the World Health Organization. When it was discovered that workers in China were downplaying the outbreak, the Political Bureau of the Central Committee of the Communist Party of China ordered that information on the outbreak be released daily and that people withholding information could receive punishments as severe as dismissal.¹¹
Funding public health planning and preparedness programs is essential to a rapid response team’s abilities to diagnose, contain, and treat epidemics in a timely manner,
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