Law and the Public’s Health Welcome to the first edition of the online version of Law and the Public’s Health. This longstanding regular department of Public Health Reports (PHR), which explores emerging issues in public health law and policy, now will be available online prior to print publication. We are extremely grateful to be able to inaugurate this regular online offering with an editorial by four of the nation’s leading experts in public health policy and law—James Hodge, Lawrence Gostin, Dan Hanfling, and John Hick. Their editorial focuses on Ebola, the latest test of the strength and capacity of the U.S. public health system, and the legal environment in which it operates. This article was published on October 30, 2014, at www.publichealthreports.org. Sara Rosenbaum, JD George Washington University, Milken Institute School of Public Health Department of Health Policy, Washington, DC
LAW, MEDICINE, AND PUBLIC HEALTH PREPAREDNESS: THE CASE OF EBOLA James G. Hodge, Jr., JD, LLM Lawrence O. Gostin, JD, LLD (Hon.) Dan Hanfling, MD John L. Hick, MD
The Ebola crisis overseas has come ashore to the United States, resulting in a series of effective public health responses and some high-visibility errors. Although the U.S. has had only one imported case from West Africa as of October 27, 2014, several missteps in handling the case in Dallas, Texas, led to the release of an Ebola patient after initial presentation to a hospital emergency room, potential exposures of dozens of people, and the subsequent infection of two nurses.1 One of the nurses with symptoms was permitted to fly on commercial airliners, placing hundreds of additional Americans at some risk of infection, albeit minimal.2 Media coverage of the domestic “Ebola outbreak”3 has fueled public concerns and the naming of America’s first “Ebola Czar,” Ron Klain.4 The nation’s preparedness capabilities are under question.1 Dr. Georges Benjamin, Executive Director of the American Public Health Association, suggests that “[a] strong, well-developed and adequately funded public health system is the key to containing Ebola.”5 However, years of funding cuts, loss of personnel, and political apathy have stripped the public health system to its core even as expenditures for health care have risen exponentially.1 U.S. public health agencies must rely on the frontline efforts of doctors, nurses, and other health workers equipped with sufficient legal authority and knowledge to control emerging health threats such as Ebola and protect the public’s health. The stakes are
high in the face of an infectious condition for which there is no approved vaccine or reliable treatment, and the fatality rate ranges from 30% to 70% globally.6 In this column, two public health lawyers and two emergency medicine physicians who served together on the Institute of Medicine Crisis Standards of Care Committee from 2009 to 20127 share guidance on controversial topics at the intersection of law, medicine, and preparedness for Ebola, including (1) the willingness among health workers and entities to handle patients suspected or known to be infected; (2) novel treatments and administration of experimental drugs; (3) implementation of isolation, quarantine, and other social-distancing measures in medical settings; and (4) prospective liabilities of health workers or entities for medical errors or omissions in the handling or treatment of Ebola cases. HEALTH WORKER WILLINGNESS TO RESPOND As with human immunodeficiency virus/acquired immunodeficiency syndrome, severe acute respiratory syndrome (SARS), the 2009 H1N1 influenza pandemic, and other epidemics, Ebola thrusts health workers into precarious situations that risk their safety or lives. In West Africa, more than 400 health workers have been infected with the virus, and 230 have died as of October 14, 2014.8 Risks of exposure, infection, and death are not limited to affected regions in Africa. Several health workers in industrialized countries, including Spain9 and the U.S.,1 have contracted Ebola despite access to personal protective equipment (PPE) and infection-control practices intended to prevent such outcomes.10 These preventable infections led the U.S. Centers for Disease Control and Prevention (CDC) and state public health agencies to overhaul protocols for handling Ebola patients in hospitals and emergency
Public Health Reports / March–April 2015 / Volume 130
167
168 Law and the Public’s Health
medical services and lend their expertise early upon initial identification of suspect cases. Health workers’ duties to care for patients are well supported in law and ethics and are essential to the delivery of medical services.11 However, these duties must be reconciled with the real risks faced by workers responding to Ebola. Frontline providers worry about their ability to deliver care safely with a paucity of appropriate training, limited experience in the use of PPE, questionable protection standards,12 and hospital emergency management programs that have lost ground during the years since their robust development following 9/11.13 The willingness of health workers to respond under dangerous conditions is predicated on system capacities to equip them with adequate PPE, training, knowledge, and supervision needed to remain safe. Human resource policies must be sufficiently flexible to accommodate staff willing to volunteer to care for Ebola patients, as well as those who are unwilling due to personal health risks or concerns. Federal and state public health laws, employment contracts, and licensure standards may require health workers to provide care to Ebola patients. Patients arriving with emergency conditions at hospital emergency rooms are required to be screened and stabilized pursuant to the federal Emergency Medical Treatment and Active Labor Act (EMTALA).14 Yet, legally mandating workers to handle patients is not preferable to seeking their voluntary efforts. Health workers treating Ebola patients to date at Emory University Hospital in Atlanta—one of the national treatment centers for cases of highly infectious diseases—act on their own volition with strong institutional support. EXPERIMENTAL DRUGS AND TREATMENTS Evaluating novel and relatively untested vaccines and therapeutics is challenging when nearly every intervention for Ebola is experimental. Successful patient outcomes may be equally attributable to supportive care as to any therapeutic drugs or specific interventions. Conducting randomized trials of potentially beneficial vaccines and medications is limited by a lack of prospective participants in developed countries and difficulty controlling for inconsistent, supportive care. Few Ebola patients would likely turn away available experimental therapies or care techniques when facing significant risks of mortality. Organizing a human clinical trial for a drug that few have received is problematic ethically when risks and benefits of participation cannot even be well described. Garnering truly informed consent from patients is complicated by the real threat of death. In this climate, it may be appealing to try any experi-
mental Ebola treatment or drug, but legal restrictions still prohibit the use of unapproved drugs or other therapies absent exceptions. The U.S. Food and Drug Administration (FDA) is authorized to allow the select use of experimental therapies through its powers to issue emergency use authorizations (e.g., Ebola assay tests), expedited investigational drug processes (e.g., brincidofovir), and limited exceptions for compassionate use (e.g., ZMapp).15 Approvals through each of these exceptions entail a precise series of legal steps; failure to follow them results in access denials. Consistent with medical and public health ethics, as well as laws aimed at ensuring nondiscrimination in health care, providing experimental treatments that offer untold benefits or harms may be selective. Factoring in costs further muddles the issues. It takes millions of dollars to produce experimental drugs such as ZMapp.16 Even if sufficient doses were available and affordable for a handful of patients in the U.S., tens of thousands of people in West Africa would be left untreated, which is patently inequitable. The current distribution of prior and existing Ebola treatments to citizens of first-world nations heightens sensitivities to the injustices underlying access to care, reflected by allegations surrounding the treatment of Liberian Thomas Eric Duncan, who died in Dallas on October 8, 2014.17 Suggestions that costs and race considerations contributed to delays in applying for experimental treatments and providing aggressive care to Duncan are unproven.18 If shown, however, legal liability under federal and state law would follow. SOCIAL-DISTANCING MEASURES IN MEDICAL SETTINGS Most patients who suspect they may have contracted Ebola will voluntarily seek medical care even if it includes temporary isolation from family and friends. If a suspected Ebola patient declines testing or treatment, health workers and public health agents may take legal action to minimize risks to the public’s health. Isolation of highly infectious patients is often accompanied by quarantine of related people exposed to the patient but who are not yet known to be infectious. As with Duncan and his contacts, these social-distancing powers are typically exercised pursuant to state or local public health laws.19 Through its federal quarantine power, CDC has the legal tools needed to control importation and interstate transmission of specified communicable diseases,20,21 but it typically uses these powers only at ports of entry or in time-sensitive situations.22 Use of isolation or quarantine powers triggers significant due process interests of those impacted, including fair notice and rights to hearing, access to
Public Health Reports / March–April 2015 / Volume 130
Law and the Public’s Health 169
available treatment, adequate sustenance and housing, and appeals.23 Some of these measures (e.g., right to hearing and appeals) may follow the initial application of isolation. Above all is the need to assure the safety of those subject to compulsory powers. Some of these requirements may be altered or expedited in exigencies. For example, Minnesota24 and other states authorize ex parte orders (granted by a judge without a formal hearing or the parties’ presence) to initiate or impose continued isolation in suspected or known cases, although nonconsensual treatments may not be required (except in cases of minors or wards of the state). Health workers may also be subject to quarantine if they are exposed to Ebola at the workplace despite their use of PPE and adherence to strict protocols. Private hospitals and other health-care entities may ask hospital employees or others (not already infected with Ebola) who risk exposure due to their failure to adhere to infection-control policies to vacate the premises. During the 2003 SARS outbreak, health workers were instructed to self-quarantine as needed unless they developed fever and other symptoms for which they may become infectious.25 Nurses and other staff in Dallas who treated Duncan were placed under limited quarantine orders, including travel restrictions, after two tested positive for Ebola. Application of isolation or quarantine orders promotes public health and safety of patients, contacts, and workers. They are nonpunitive unless someone attempts to evade orders in ways that place others at direct risk. In such rare cases, evasion may be criminally prosecuted either as a contempt of court violation or pursuant to specific sanctions. In the event of an Ebola outbreak in any U.S. community, public health agencies may utilize more extensive social-distancing measures pursuant to emergency declarations. The U.S. Department of Health and Human Services, along with 26 states and many larger municipal governments, can declare states of “public health emergency.”26 Connecticut was the first state to do so in response to Ebola on October 6, 2014.27 Other jurisdictions may declare general states of disaster or emergency. Emergency public health powers not only heighten response capabilities and allow temporary legal waivers of potential impediments, they can also alter the legal liability landscape. POTENTIAL LIABILITIES OF HEALTH WORKERS AND ENTITIES Uncertainties concerning how easily Ebola spreads, as well as optimal treatment and safety protocols,
contribute to liability concerns among hospitals and health providers. The specter of liability hangs heavy over actors and entities attempting to navigate successful handling and treatment of Ebola patients in health-care environments.7 Claims may extend from actions or failures to act. Doctors who misdiagnose, delay treatments, or attempt to treat Ebola patients with experimental treatments or drugs that lack efficacy leading to patient harms may face allegations of medical malpractice or wrongful death. Workers exposed to Ebola in health-care settings are entitled to compensation. Those refusing to handle or treat Ebola patients despite adequate training and PPE may be subject to claims of disability discrimination, potential licensure sanctions, or termination. Hospital emergency departments turning away suspect patients without adequate screening or stabilization may face government penalties as well as institutional liability under EMTALA.14 Hospital administrators who fail to plan adequately for Ebola cases may be liable for their omissions.28 Liability risks are real but avoidable. Adequate advance planning obviates many claims through assurances of appropriate care and the use of PPE to prevent subsequent harms,29 including infection of health workers handling Ebola patients. EMTALA sanctions can be avoided through screening protocols and/or advance agreements of specialist treatment centers to accept consensual transfers of patients, space permitting. Localized outbreaks or limits of safe and efficacious medical interventions may lend to implementation of crisis standards of care. Resulting shifts in the allocation of limited resources and concomitant changes in medical standards can diminish legal malpractice claims.7 If additional governments formally declare states of emergency, explicit liability protections for health workers and entities take effect for the duration of the declaration in many jurisdictions.23 These protections may negate claims grounded in negligence for real-time decisions or actions of workers in the throes of medical triage, as well as alleged scope of practice violations or breaches of health information privacy protections. Expansion of broad liability protections during emergencies encourages workers’ response efforts without fear of retaliation for potential, unintended harms.7 CONCLUSION Cases of highly infectious diseases such as Ebola with significant mortality rates heighten public health concerns. Mitigating these fears entails affirmative public health and health-care responses undergirded by the judicious use of legal tools and options to protect the safety of health workers and communities and provide
Public Health Reports / March–April 2015 / Volume 130
170 Law and the Public’s Health
patients and contacts with comprehensive medical and public health services. Balancing duties and risks at the intersection of law, medicine, and preparedness is about assuring optimal and compassionate treatments for those who are ill and preserving the public’s health. This article was supported in part by the Robert Wood Johnson Foundation (RWJF) through the Network for Public Health Law – Western Region Office, Sandra Day O’Connor College of Law, Arizona State University. Any views or opinions expressed in this article are those of the authors and are not the views of RWJF or other project partners. The authors acknowledge Asha Agrawal and Rose Meltzer at Arizona State University for their research, editing, and formatting assistance. James G. Hodge, Jr., is Associate Dean and Professor of Public Health Law and Ethics and Director, Network for Public Health Law – Western Region Office, Sandra Day O’Connor College of Law, Arizona State University in Tempe, Arizona. Lawrence O. Gostin is University Professor and Founding Director of The O’Neill Institute for National and Global Health Law at Georgetown University Law Center in Washington, D.C. Dan Hanfling is a Contributing Scholar at the UPMC Center for Health Security in Baltimore, Maryland, and Clinical Professor of Emergency Medicine at George Washington University in Washington, DC. John L. Hick is a Faculty Emergency Physician at the Hennepin County Medical Center and Professor of Emergency Medicine at the University of Minnesota in Minneapolis, Minnesota. Address correspondence to: James G. Hodge, Jr., JD, LLM, Sandra Day O’Connor College of Law, Arizona State University, PO Box 877906, Tempe, AZ 85287-7906; tel. 480-727-8576; fax 480-727-6973; e-mail .
REFERENCES 1. Gostin LO, Hodge JG Jr, Burris S. Is the United States prepared for Ebola? JAMA 2014;E1-2. 2. Centers for Disease Control and Prevention (US). CDC and Frontier Airlines announce passenger notification underway. 2014 Oct 15 [cited 2014 Oct 15]. Available from: URL: http://www.cdc.gov /media/releases/2014/s1015-airline-notification.html 3. Yan H. Ebola outbreak: get up to speed. CNN 2014 Oct 27 [cited 2014 Oct 27]. Available from: URL: http://www.cnn .com/2014/10/27/health/ebola-up-to-speed 4. Jackson D. Obama names Ron Klain as Ebola “czar.” USA Today 2014 Oct 17 [cited 2014 Oct 27]. Available from: URL: http://www.usatoday.com/story/news/politics/2014/10/17 /obama-ebola-czar-ron-klain/17429121 5. Benjamin G. Ebola doesn’t abide by borders. Public Health Newswire 2014 Oct 10 [cited 2014 Oct 14]. Available from: URL: http://www .publichealthnewswire.org/?p=11383 6. Ross P. Survival rates: why patients’ outcomes vary. International Business Times 2014 Oct 21 [cited 2014 Oct 27]. Available from: URL: http://www.ibtimes.com/ebola-survival-rates-why-patientsoutcomes-vary-1708555 7. Institute of Medicine. Crisis standards of care: a systems framework for catastrophic disaster response. Washington: National Academies Press; 2012. 8. World Health Organization Regional Office for Europe. Situation reports: Ebola response roadmap [cited 2014 Oct 14]. Available from: URL: http://www.who.int/csr/disease/ebola /situation-reports/en
9. World Health Organization Regional Office for Europe. Spanish nurse diagnosed with Ebola virus disease. 2014 Oct 7 [cited 2014 Oct 21]. Available from: URL: http://www.euro.who.int /en/health-topics/emergencies/pages/news/news/2014/10 /spanish-nurse-diagnosed-with-ebola-virus-disease 10. American Medical Association. CDC bolstering efforts to equip health care workers for Ebola. 2014 Oct 14 [cited 2014 Oct 21]. Available from: URL: http://www.ama-assn.org/ama/pub/ama-wire/ama-wire /post/cdc-bolstering-efforts-equip-health-care-workers-ebola 11. Sokol DK. Virulent epidemics and scope of healthcare workers’ duty of care. Emerg Infect Dis 2006;12:1238-41. 12. Greenemeier L. Ebola spread shows flaws in protective gear and procedures. Scientific American 2014 Oct 10 [cited 2014 Oct 21]. Available from: URL: http://www.scientificamerican.com/article /ebola-spread-shows-flaws-in-protective-gear-and-procedures 13. Bevington F. Are preparedness funding cuts impacting the capability of local health departments to respond to global health security threats? National Association of County and City Health Officials 2014 Sep 30 [cited 2014 Oct 14]. Available from: URL: http:// nacchopreparedness.org/?p=3263 14. 42 U.S.C. §1395dd (2011). 15. Borio L. FDA works to mitigate the West Africa Ebola outbreak. FDA Voice 2014 Aug 22 [cited 2014 Oct 15]. Available from: URL: http://blogs.fda.gov/fdavoice/index.php/tag /emergency-investigational-new-drug-eind 16. CenterWatch News Online. HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola. 2014 Sep 4 [cited 2014 Oct 26]. Available from: URL: http://www.centerwatch.com/newsonline/article/6805/hhs-contracts-with-mapp-biopharmaceuticalto-develop-zmapp-for-ebola#sthash.mzR4YwPn.dpbs 17. Izadi E. Texas hospital responds to questions over treatment of Ebola patient Thomas Eric Duncan. The Washington Post 2014 Oct 9 [cited 2014 Oct 15]. Available from: URL: http:// www.washingtonpost.com/news/to-your-health/wp/2014/10/09 /texas-hospital-responds-to-questions-over-treatment-of-ebolapatient-thomas-eric-duncan 18. Hennessy-Fiske M, Susman T. Thomas Eric Duncan of Liberia dies of Ebola in Dallas. Los Angeles Times 2014 Oct 8 [cited 2014 Oct 15]. Available from: URL: http://www.latimes.com/nation/la-naebola-patient-dies-20141007-story.html#page=1 19. National Conference of State Legislatures. State quarantine and isolation statutes [cited 2014 Oct 23]. Available from: URL: http:// www.ncsl.org/research/health/state-quarantine-and-isolationstatutes.aspx#1 20. 42 U.S.C. §264-72 (2011). 21. 42 C.F.R. §70.4, 71.21(b) (2007). 22. Misrahi JJ, Foster JA, Shaw FE, Cetron MS. HHS/CDC legal response to SARS outbreak. Emerg Infect Dis 2004;10:353-5. 23. Gostin LO. Public health law: power, duty, restraint. 2nd ed. Berkeley (CA): University of California Press; 2008. 24. Minn. Stat. §144.419 (2014). 25. Centers for Disease Control and Prevention (US). Severe acute respiratory syndrome (SARS): recommended preparedness and response activities in healthcare facilities. 2005 [cited 2014 Oct 21]. Available from: URL: http://www.cdc.gov/sars/guidance/Chealthcare/recommended.html 26. Hodge JG Jr. Public health law in a nutshell. Eagan (MN): West Academic Publishing; 2013. 27. Altimari D. Ebola concerns prompt Malloy to declare public health emergency. Hartford Courant 2014 Oct 7 [cited 2014 Oct 15]. Available from: URL: http://www.courant.com/politics/capitol-watch /hc-ebola-concerns-prompt-ct-gov-malloy-to-proactively-declarespublic-health-emergency-20141007-story.html 28. Hodge JG Jr, Brown EF. Assessing liability for health care entities that insufficiently prepare for catastrophic emergencies. JAMA 2011;306:308-9. 29. Hodge JG Jr, Gable LA, Calves SH. Volunteer health professionals and emergencies: assessing and transforming the legal environment. Biosecur Bioterror 2005;3:216-23.
Public Health Reports / March–April 2015 / Volume 130
LAW, MEDICINE, AND PUBLIC HEALTH PREPAREDNESS: THE CASE OF EBOLA James G. Hodge, Jr., JD, LLM Lawrence O. Gostin, JD, LLD (Hon.) Dan Hanfling, MD John L. Hick, MD
The Ebola crisis overseas has come ashore to the United States, resulting in a series of effective public health responses and some high-visibility errors. Although the U.S. has had only one imported case from West Africa as of October 27, 2014, several missteps in handling the case in Dallas, Texas, led to the release of an Ebola patient after initial presentation to a hospital emergency room, potential exposures of dozens of people, and the subsequent infection of two nurses.1 One of the nurses with symptoms was permitted to fly on commercial airliners, placing hundreds of additional Americans at some risk of infection, albeit minimal.2 Media coverage of the domestic “Ebola outbreak”3 has fueled public concerns and the naming of America’s first “Ebola Czar,” Ron Klain.4 The nation’s preparedness capabilities are under question.1 Dr. Georges Benjamin, Executive Director of the American Public Health Association, suggests that “[a] strong, well-developed and adequately funded public health system is the key to containing Ebola.”5 However, years of funding cuts, loss of personnel, and political apathy have stripped the public health system to its core even as expenditures for health care have risen exponentially.1 U.S. public health agencies must rely on the frontline efforts of doctors, nurses, and other health workers equipped with sufficient legal authority and knowledge to control emerging health threats such as Ebola and protect the public’s health. The stakes are
high in the face of an infectious condition for which there is no approved vaccine or reliable treatment, and the fatality rate ranges from 30% to 70% globally.6 In this column, two public health lawyers and two emergency medicine physicians who served together on the Institute of Medicine Crisis Standards of Care Committee from 2009 to 20127 share guidance on controversial topics at the intersection of law, medicine, and preparedness for Ebola, including (1) the willingness among health workers and entities to handle patients suspected or known to be infected; (2) novel treatments and administration of experimental drugs; (3) implementation of isolation, quarantine, and other social-distancing measures in medical settings; and (4) prospective liabilities of health workers or entities for medical errors or omissions in the handling or treatment of Ebola cases. HEALTH WORKER WILLINGNESS TO RESPOND As with human immunodeficiency virus/acquired immunodeficiency syndrome, severe acute respiratory syndrome (SARS), the 2009 H1N1 influenza pandemic, and other epidemics, Ebola thrusts health workers into precarious situations that risk their safety or lives. In West Africa, more than 400 health workers have been infected with the virus, and 230 have died as of October 14, 2014.8 Risks of exposure, infection, and death are not limited to affected regions in Africa. Several health workers in industrialized countries, including Spain9 and the U.S.,1 have contracted Ebola despite access to personal protective equipment (PPE) and infection-control practices intended to prevent such outcomes.10 These preventable infections led the U.S. Centers for Disease Control and Prevention (CDC) and state public health agencies to overhaul protocols for handling Ebola patients in hospitals and emergency
Public Health Reports / March–April 2015 / Volume 130
167
168 Law and the Public’s Health
medical services and lend their expertise early upon initial identification of suspect cases. Health workers’ duties to care for patients are well supported in law and ethics and are essential to the delivery of medical services.11 However, these duties must be reconciled with the real risks faced by workers responding to Ebola. Frontline providers worry about their ability to deliver care safely with a paucity of appropriate training, limited experience in the use of PPE, questionable protection standards,12 and hospital emergency management programs that have lost ground during the years since their robust development following 9/11.13 The willingness of health workers to respond under dangerous conditions is predicated on system capacities to equip them with adequate PPE, training, knowledge, and supervision needed to remain safe. Human resource policies must be sufficiently flexible to accommodate staff willing to volunteer to care for Ebola patients, as well as those who are unwilling due to personal health risks or concerns. Federal and state public health laws, employment contracts, and licensure standards may require health workers to provide care to Ebola patients. Patients arriving with emergency conditions at hospital emergency rooms are required to be screened and stabilized pursuant to the federal Emergency Medical Treatment and Active Labor Act (EMTALA).14 Yet, legally mandating workers to handle patients is not preferable to seeking their voluntary efforts. Health workers treating Ebola patients to date at Emory University Hospital in Atlanta—one of the national treatment centers for cases of highly infectious diseases—act on their own volition with strong institutional support. EXPERIMENTAL DRUGS AND TREATMENTS Evaluating novel and relatively untested vaccines and therapeutics is challenging when nearly every intervention for Ebola is experimental. Successful patient outcomes may be equally attributable to supportive care as to any therapeutic drugs or specific interventions. Conducting randomized trials of potentially beneficial vaccines and medications is limited by a lack of prospective participants in developed countries and difficulty controlling for inconsistent, supportive care. Few Ebola patients would likely turn away available experimental therapies or care techniques when facing significant risks of mortality. Organizing a human clinical trial for a drug that few have received is problematic ethically when risks and benefits of participation cannot even be well described. Garnering truly informed consent from patients is complicated by the real threat of death. In this climate, it may be appealing to try any experi-
mental Ebola treatment or drug, but legal restrictions still prohibit the use of unapproved drugs or other therapies absent exceptions. The U.S. Food and Drug Administration (FDA) is authorized to allow the select use of experimental therapies through its powers to issue emergency use authorizations (e.g., Ebola assay tests), expedited investigational drug processes (e.g., brincidofovir), and limited exceptions for compassionate use (e.g., ZMapp).15 Approvals through each of these exceptions entail a precise series of legal steps; failure to follow them results in access denials. Consistent with medical and public health ethics, as well as laws aimed at ensuring nondiscrimination in health care, providing experimental treatments that offer untold benefits or harms may be selective. Factoring in costs further muddles the issues. It takes millions of dollars to produce experimental drugs such as ZMapp.16 Even if sufficient doses were available and affordable for a handful of patients in the U.S., tens of thousands of people in West Africa would be left untreated, which is patently inequitable. The current distribution of prior and existing Ebola treatments to citizens of first-world nations heightens sensitivities to the injustices underlying access to care, reflected by allegations surrounding the treatment of Liberian Thomas Eric Duncan, who died in Dallas on October 8, 2014.17 Suggestions that costs and race considerations contributed to delays in applying for experimental treatments and providing aggressive care to Duncan are unproven.18 If shown, however, legal liability under federal and state law would follow. SOCIAL-DISTANCING MEASURES IN MEDICAL SETTINGS Most patients who suspect they may have contracted Ebola will voluntarily seek medical care even if it includes temporary isolation from family and friends. If a suspected Ebola patient declines testing or treatment, health workers and public health agents may take legal action to minimize risks to the public’s health. Isolation of highly infectious patients is often accompanied by quarantine of related people exposed to the patient but who are not yet known to be infectious. As with Duncan and his contacts, these social-distancing powers are typically exercised pursuant to state or local public health laws.19 Through its federal quarantine power, CDC has the legal tools needed to control importation and interstate transmission of specified communicable diseases,20,21 but it typically uses these powers only at ports of entry or in time-sensitive situations.22 Use of isolation or quarantine powers triggers significant due process interests of those impacted, including fair notice and rights to hearing, access to
Public Health Reports / March–April 2015 / Volume 130
Law and the Public’s Health 169
available treatment, adequate sustenance and housing, and appeals.23 Some of these measures (e.g., right to hearing and appeals) may follow the initial application of isolation. Above all is the need to assure the safety of those subject to compulsory powers. Some of these requirements may be altered or expedited in exigencies. For example, Minnesota24 and other states authorize ex parte orders (granted by a judge without a formal hearing or the parties’ presence) to initiate or impose continued isolation in suspected or known cases, although nonconsensual treatments may not be required (except in cases of minors or wards of the state). Health workers may also be subject to quarantine if they are exposed to Ebola at the workplace despite their use of PPE and adherence to strict protocols. Private hospitals and other health-care entities may ask hospital employees or others (not already infected with Ebola) who risk exposure due to their failure to adhere to infection-control policies to vacate the premises. During the 2003 SARS outbreak, health workers were instructed to self-quarantine as needed unless they developed fever and other symptoms for which they may become infectious.25 Nurses and other staff in Dallas who treated Duncan were placed under limited quarantine orders, including travel restrictions, after two tested positive for Ebola. Application of isolation or quarantine orders promotes public health and safety of patients, contacts, and workers. They are nonpunitive unless someone attempts to evade orders in ways that place others at direct risk. In such rare cases, evasion may be criminally prosecuted either as a contempt of court violation or pursuant to specific sanctions. In the event of an Ebola outbreak in any U.S. community, public health agencies may utilize more extensive social-distancing measures pursuant to emergency declarations. The U.S. Department of Health and Human Services, along with 26 states and many larger municipal governments, can declare states of “public health emergency.”26 Connecticut was the first state to do so in response to Ebola on October 6, 2014.27 Other jurisdictions may declare general states of disaster or emergency. Emergency public health powers not only heighten response capabilities and allow temporary legal waivers of potential impediments, they can also alter the legal liability landscape. POTENTIAL LIABILITIES OF HEALTH WORKERS AND ENTITIES Uncertainties concerning how easily Ebola spreads, as well as optimal treatment and safety protocols,
contribute to liability concerns among hospitals and health providers. The specter of liability hangs heavy over actors and entities attempting to navigate successful handling and treatment of Ebola patients in health-care environments.7 Claims may extend from actions or failures to act. Doctors who misdiagnose, delay treatments, or attempt to treat Ebola patients with experimental treatments or drugs that lack efficacy leading to patient harms may face allegations of medical malpractice or wrongful death. Workers exposed to Ebola in health-care settings are entitled to compensation. Those refusing to handle or treat Ebola patients despite adequate training and PPE may be subject to claims of disability discrimination, potential licensure sanctions, or termination. Hospital emergency departments turning away suspect patients without adequate screening or stabilization may face government penalties as well as institutional liability under EMTALA.14 Hospital administrators who fail to plan adequately for Ebola cases may be liable for their omissions.28 Liability risks are real but avoidable. Adequate advance planning obviates many claims through assurances of appropriate care and the use of PPE to prevent subsequent harms,29 including infection of health workers handling Ebola patients. EMTALA sanctions can be avoided through screening protocols and/or advance agreements of specialist treatment centers to accept consensual transfers of patients, space permitting. Localized outbreaks or limits of safe and efficacious medical interventions may lend to implementation of crisis standards of care. Resulting shifts in the allocation of limited resources and concomitant changes in medical standards can diminish legal malpractice claims.7 If additional governments formally declare states of emergency, explicit liability protections for health workers and entities take effect for the duration of the declaration in many jurisdictions.23 These protections may negate claims grounded in negligence for real-time decisions or actions of workers in the throes of medical triage, as well as alleged scope of practice violations or breaches of health information privacy protections. Expansion of broad liability protections during emergencies encourages workers’ response efforts without fear of retaliation for potential, unintended harms.7 CONCLUSION Cases of highly infectious diseases such as Ebola with significant mortality rates heighten public health concerns. Mitigating these fears entails affirmative public health and health-care responses undergirded by the judicious use of legal tools and options to protect the safety of health workers and communities and provide
Public Health Reports / March–April 2015 / Volume 130
170 Law and the Public’s Health
patients and contacts with comprehensive medical and public health services. Balancing duties and risks at the intersection of law, medicine, and preparedness is about assuring optimal and compassionate treatments for those who are ill and preserving the public’s health. This article was supported in part by the Robert Wood Johnson Foundation (RWJF) through the Network for Public Health Law – Western Region Office, Sandra Day O’Connor College of Law, Arizona State University. Any views or opinions expressed in this article are those of the authors and are not the views of RWJF or other project partners. The authors acknowledge Asha Agrawal and Rose Meltzer at Arizona State University for their research, editing, and formatting assistance. James G. Hodge, Jr., is Associate Dean and Professor of Public Health Law and Ethics and Director, Network for Public Health Law – Western Region Office, Sandra Day O’Connor College of Law, Arizona State University in Tempe, Arizona. Lawrence O. Gostin is University Professor and Founding Director of The O’Neill Institute for National and Global Health Law at Georgetown University Law Center in Washington, D.C. Dan Hanfling is a Contributing Scholar at the UPMC Center for Health Security in Baltimore, Maryland, and Clinical Professor of Emergency Medicine at George Washington University in Washington, DC. John L. Hick is a Faculty Emergency Physician at the Hennepin County Medical Center and Professor of Emergency Medicine at the University of Minnesota in Minneapolis, Minnesota. Address correspondence to: James G. Hodge, Jr., JD, LLM, Sandra Day O’Connor College of Law, Arizona State University, PO Box 877906, Tempe, AZ 85287-7906; tel. 480-727-8576; fax 480-727-6973; e-mail .
REFERENCES 1. Gostin LO, Hodge JG Jr, Burris S. Is the United States prepared for Ebola? JAMA 2014;E1-2. 2. Centers for Disease Control and Prevention (US). CDC and Frontier Airlines announce passenger notification underway. 2014 Oct 15 [cited 2014 Oct 15]. Available from: URL: http://www.cdc.gov /media/releases/2014/s1015-airline-notification.html 3. Yan H. Ebola outbreak: get up to speed. CNN 2014 Oct 27 [cited 2014 Oct 27]. Available from: URL: http://www.cnn .com/2014/10/27/health/ebola-up-to-speed 4. Jackson D. Obama names Ron Klain as Ebola “czar.” USA Today 2014 Oct 17 [cited 2014 Oct 27]. Available from: URL: http://www.usatoday.com/story/news/politics/2014/10/17 /obama-ebola-czar-ron-klain/17429121 5. Benjamin G. Ebola doesn’t abide by borders. Public Health Newswire 2014 Oct 10 [cited 2014 Oct 14]. Available from: URL: http://www .publichealthnewswire.org/?p=11383 6. Ross P. Survival rates: why patients’ outcomes vary. International Business Times 2014 Oct 21 [cited 2014 Oct 27]. Available from: URL: http://www.ibtimes.com/ebola-survival-rates-why-patientsoutcomes-vary-1708555 7. Institute of Medicine. Crisis standards of care: a systems framework for catastrophic disaster response. Washington: National Academies Press; 2012. 8. World Health Organization Regional Office for Europe. Situation reports: Ebola response roadmap [cited 2014 Oct 14]. Available from: URL: http://www.who.int/csr/disease/ebola /situation-reports/en
9. World Health Organization Regional Office for Europe. Spanish nurse diagnosed with Ebola virus disease. 2014 Oct 7 [cited 2014 Oct 21]. Available from: URL: http://www.euro.who.int /en/health-topics/emergencies/pages/news/news/2014/10 /spanish-nurse-diagnosed-with-ebola-virus-disease 10. American Medical Association. CDC bolstering efforts to equip health care workers for Ebola. 2014 Oct 14 [cited 2014 Oct 21]. Available from: URL: http://www.ama-assn.org/ama/pub/ama-wire/ama-wire /post/cdc-bolstering-efforts-equip-health-care-workers-ebola 11. Sokol DK. Virulent epidemics and scope of healthcare workers’ duty of care. Emerg Infect Dis 2006;12:1238-41. 12. Greenemeier L. Ebola spread shows flaws in protective gear and procedures. Scientific American 2014 Oct 10 [cited 2014 Oct 21]. Available from: URL: http://www.scientificamerican.com/article /ebola-spread-shows-flaws-in-protective-gear-and-procedures 13. Bevington F. Are preparedness funding cuts impacting the capability of local health departments to respond to global health security threats? National Association of County and City Health Officials 2014 Sep 30 [cited 2014 Oct 14]. Available from: URL: http:// nacchopreparedness.org/?p=3263 14. 42 U.S.C. §1395dd (2011). 15. Borio L. FDA works to mitigate the West Africa Ebola outbreak. FDA Voice 2014 Aug 22 [cited 2014 Oct 15]. Available from: URL: http://blogs.fda.gov/fdavoice/index.php/tag /emergency-investigational-new-drug-eind 16. CenterWatch News Online. HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola. 2014 Sep 4 [cited 2014 Oct 26]. Available from: URL: http://www.centerwatch.com/newsonline/article/6805/hhs-contracts-with-mapp-biopharmaceuticalto-develop-zmapp-for-ebola#sthash.mzR4YwPn.dpbs 17. Izadi E. Texas hospital responds to questions over treatment of Ebola patient Thomas Eric Duncan. The Washington Post 2014 Oct 9 [cited 2014 Oct 15]. Available from: URL: http:// www.washingtonpost.com/news/to-your-health/wp/2014/10/09 /texas-hospital-responds-to-questions-over-treatment-of-ebolapatient-thomas-eric-duncan 18. Hennessy-Fiske M, Susman T. Thomas Eric Duncan of Liberia dies of Ebola in Dallas. Los Angeles Times 2014 Oct 8 [cited 2014 Oct 15]. Available from: URL: http://www.latimes.com/nation/la-naebola-patient-dies-20141007-story.html#page=1 19. National Conference of State Legislatures. State quarantine and isolation statutes [cited 2014 Oct 23]. Available from: URL: http:// www.ncsl.org/research/health/state-quarantine-and-isolationstatutes.aspx#1 20. 42 U.S.C. §264-72 (2011). 21. 42 C.F.R. §70.4, 71.21(b) (2007). 22. Misrahi JJ, Foster JA, Shaw FE, Cetron MS. HHS/CDC legal response to SARS outbreak. Emerg Infect Dis 2004;10:353-5. 23. Gostin LO. Public health law: power, duty, restraint. 2nd ed. Berkeley (CA): University of California Press; 2008. 24. Minn. Stat. §144.419 (2014). 25. Centers for Disease Control and Prevention (US). Severe acute respiratory syndrome (SARS): recommended preparedness and response activities in healthcare facilities. 2005 [cited 2014 Oct 21]. Available from: URL: http://www.cdc.gov/sars/guidance/Chealthcare/recommended.html 26. Hodge JG Jr. Public health law in a nutshell. Eagan (MN): West Academic Publishing; 2013. 27. Altimari D. Ebola concerns prompt Malloy to declare public health emergency. Hartford Courant 2014 Oct 7 [cited 2014 Oct 15]. Available from: URL: http://www.courant.com/politics/capitol-watch /hc-ebola-concerns-prompt-ct-gov-malloy-to-proactively-declarespublic-health-emergency-20141007-story.html 28. Hodge JG Jr, Brown EF. Assessing liability for health care entities that insufficiently prepare for catastrophic emergencies. JAMA 2011;306:308-9. 29. Hodge JG Jr, Gable LA, Calves SH. Volunteer health professionals and emergencies: assessing and transforming the legal environment. Biosecur Bioterror 2005;3:216-23.
Public Health Reports / March–April 2015 / Volume 130
