NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Committee on Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations; Institute of Medicine. Crisis Standards of Care: A Systems Framework for Catastrophic Disaster Response. Washington (DC): National Academies Press (US); 2012 Mar 21.

Cover of Crisis Standards of Care

Crisis Standards of Care: A Systems Framework for Catastrophic Disaster Response.

Show details

3Legal Issues in Emergencies

As noted in the committee’s 2009 letter report, significant legal challenges are associated with catastrophic disasters involving the allocation of scarce health care resources and the establishment of crisis standards of care (CSC). These issues cut across nearly all levels of the public and private sectors involved in coordinating and providing emergency care during disaster response. To assist state and local public health and emergency planners, this chapter explores how key principles of law and policy can impede or facilitate the provision of public health and health care services during a disaster. It also addresses inherent conflicts related to the need to balance individual and communal health interests during such incidents. At the core of these issues is the need to transition rapidly from individual- to population-centric health services to save as many lives as possible and prevent injuries among patients, practitioners, and responders.

MEDICAL AND LEGAL STANDARDS OF CARE

In its letter report, the committee addressed several key issues related to distinctions between medical and legal standards of care, as well as scopes of practice for licensed health care workers. Modern studies consistently note how health care services must change during emergencies pursuant to what have been labeled “altered,” “situational,” and now “crisis” standards of care (AHRQ, 2005; AMA, 2007; Christian et al., 2006; Devereaux et al., 2008; GAO, 2008; Kanter, 2007). While the development and implementation of CSC are distinct from an assessment of prevalent liability protections, emergency planners and responders may consider whether additional liability protections are warranted in their jurisdictions, as discussed below.

The letter report described how changes in medical standards of care during an emergency may not be reflected in the corresponding legal standards of care, a disconnect that can lead to potential liability exposure for health care practitioners, volunteers, and entities during their response efforts. While medical and legal standards of care often are regarded as interchangeable, by one view they are in fact distinct concepts. According to this view, medical standards of care describe the types and levels of medical care dictated by professional norms, professional requirements, and institutional objectives (AHRQ, 2005; Hick et al., 2009; Pegalis, 2009). These standards of care vary (1) among different types of health care facilities, such as hospitals, clinics, and alternate care facilities (Hick et al., 2009); and (2) based on prevailing circumstances, including during emergencies.1 Although existing, routine medical standards of care are flexible, they do not reflect the guidance needed to assist health care practitioners attempting to allocate scarce resources and make difficult decisions (including the potential withholding or withdrawal of life-sustaining treatment) during austere conditions in a public health emergency (GAO, 2008). Legal standards of care, on the other hand, may be defined as the minimum amount of care and skill a health care practitioner should exercise in particular circumstances based on what a reasonable and prudent practitioner would do in similar circumstances (Mastroianni, 2006).2 Legal standards of care are necessarily fact-specific, flexible, and subject to differing interpretations by different courts (Dobbs, 2000). They may reflect medical standards, but do not always. For example, prior courts assessing standards of care have determined at times that prevailing medical practice was insufficient or unacceptable in exceptional cases.3,4 In these instances, practitioners have been found liable for their actions even though, based on the circumstances, their acts were consistent with the prevailing medical standards of care.

Another view suggests that legal standards of care are intrinsically tied to medical standards of care. This view assumes that changes in the medical standards, such as those during a crisis, are automatically incorporated into the way courts and other legal authorities assess whether a particular actor has breached the standards through negligence or intentional acts because the legal standards of care by definition are based on what a reasonable practitioner would do under the particular circumstances (Annas, 2010). Given the flexibility of legal standards of care, some suggest that laws offering immunity or other protections from liability for health care workers, volunteers, or entities are unnecessary or even detrimental to the extent that they may deny patients recourse for injuries caused by ne gligent acts (ABA, 2011).5 During some disasters (e.g., Hurricane Katrina in 2005), patients in specific at-risk populations, such as the elderly, racial minorities, and those of lower socioeconomic status, may suffer disproportionately relative to others. To some, it appears unfair to deny these patients direct recourse against potentially negligent health care workers. In prior national emergencies, government has created compensation funds for those impacted to help provide recourse for direct harms they may have sustained as a result of the emergency.

However, federal, state, and local governments, public health agencies, and public health and health care organizations have consistently supported limited liability or indemnification protections for health care and public health actors, especially volunteers, during emergencies. In 2008, the American Medical Association (AMA) endorsed states’ consideration of the provisions of the Uniform Volunteer Emergency Health Practitioners Act for potential enactment, specifically including provisions that protect volunteer health care practitioners from liability claims grounded in negligence (AMA, 2008).6 In 2005, the AMA adopted a resolution declaring the need for “national legislation that gives qualified physician volunteers … automatic medical liability immunity in the event of a declared national disaster or federal emergency” (AMA, 2005).

Underlying the AMA’s and other health care professionals’ positions is the recognition that adherence to reasonable legal standards of care based on prevailing circumstances may lead to unpredictable outcomes when legal disputes arise. Lacking sufficient legal precedents, the provision of reasonable care through medical triage in a crisis may be viewed by many as insufficient or negligent because it may deviate extensively from normal standards as a result of the scarcity of resources. The development of national guidance on CSC may obviate some claims by clarifying the roles and responsibilities of practitioners during an emergency, against which the reasonableness of their actions or omissions may be adjudicated. Such results, however, are not assured. Facing potential uncertainty as to how courts or other arbitrators will assess claims arising from crisis care, qualified health care practitioners, volunteers, and entities naturally are concerned about their actual or perceived risks of liability. Nonetheless, all levels of government provide limited legal liability protections for many practitioners and entities responding during emergencies to offer assurances and incentives for their participation in emergency response efforts (as detailed later in the chapter).

There are two predominant paths to assessing and resolving potential negligence claims resulting from the implementation of CSC. One path is to suggest a policy of adhering to the standards of care as they evolve along the continuum described in Chapter 2 (Box 2-4). Via this path, a negligence claim arising during the implementation of CSC should be assessed later by experts and courts based on what a reasonable practitioner would do under similar circumstances. The other path reflects a different policy approach entailing how key legal liability protections from negligence claims take effect once a state of emergency has been declared. Instead of requiring adherence to evolving standards of care, these protections, documented further below, may dispel future negligence-based claims against practitioners, volunteers, and entities in recognition of the extreme variations in the provision of population-centric care in triage-like environments, when the applicable standards of care are constantly being evaluated and changing.

THE CHANGING LEGAL ENVIRONMENT IN DECLARED EMERGENCIES

Clarity concerning CSC is necessitated in part by the changing nature of the legal environment in declared emergencies. In nonemergencies, existing laws and policies offer reasonable guidance on the empowerment of actors and entities to allocate health resources and deliver health care. During declared emergencies, however, the legal environment changes. Emergency declarations trigger an array of nontraditional powers designed to facilitate response efforts by the public and private sectors. Emergency laws may (1) provide governments with sufficient flexibility to respond (e.g., by waiving specific regulatory requirements); (2) mobilize central commands and infrastructures; (3) encourage response efforts by limiting liability; (4) authorize interstate recognition of health care licenses; (5) allocate health care personnel and resources; (6) permit the provision of health care or public health services at nontraditional, alternate care sites; and (7) facilitate essential changes to the delivery of medical services and scopes of practice (Courtney et al., 2010; Hodge et al., 2009).

The extent of legal variations during emergencies, however, depends on the type of emergency declared. The federal government, every state, many territories, and some local governments may declare either general states of “emergency” or “disaster” in response to crises that affect the public’s health (Hodge and Anderson, 2008). Such declarations largely authorize emergency management agencies and others to use general legal powers to coordinate emergency responses. The Department of Health and Human Services (HHS) and more than half the states may also declare states of “public health emergency” (Hodge et al., 2008) based in part on the Model State Emergency Health Powers Act (Centers for Law and the Public’s Health, 2001).7 Collectively, these declarations authorize an array of expedited public health powers coordinated by public health agencies in conjunction with emergency managers and other partners. The federal government and some states may declare states of both “emergency” or “disaster” and “public health emergency” in response to the same incident, such as during Hurricane Katrina and the 2009 H1N1 pandemic. These dual declarations can lead to confusion as divergent governmental powers and actors seek to respond in overlapping and potentially inconsistent ways (Hodge and Anderson, 2008).

LEGAL ISSUES IN DECLARED EMERGENCIES

From these varying emergency declarations arise a host of powers and protections that may impact the delivery of health care services depending, in part, on real-time legal interpretations. Health care practitioners and entities responsible for emergency preparedness should consider numerous legal issues that arise in responding to events along the continuum of care leading up to a declared state of emergency, as documented in Table 3-1 and summarized in relevant subsections below.

TABLE 3-1. Selected Legal Issues of Concern to Health Care Practitioners and Entities Responsible for Emergency Preparedness.

TABLE 3-1

Selected Legal Issues of Concern to Health Care Practitioners and Entities Responsible for Emergency Preparedness.

Legal Authorization to Allocate Personnel, Resources, and Supplies

Emergency declarations and ensuing orders, as noted above, can help shift how and where care is delivered and how resources (e.g., personnel, medical supplies, physical space) are allocated.8,9 Many states’ statutory emergency laws, for example, recognize out-of-state health care licenses for the limited duration of a declared emergency (Hodge et al., 2008). These “licensure reciprocity” provisions allow for the interstate sharing of out-of-state health care personnel whose licenses are viewed as in-state licenses for the duration of the declared emergency (although providers may still be subject to liability risks if they exceed their scope of practice in their home jurisdiction during their emergency response efforts). Memorandums of understanding, mutual-aid agreements, compacts, and other agreements can also facilitate the sharing of health care and other necessary resources during resource-scarce emergencies (CDC, 2011). The Emergency Management Assistance Compact (EMAC),10 for example, formalizes interstate mutual aid among all states, several territories, and the District of Columbia. Similar compacts at the regional, tribal, and municipal levels further facilitate care and distribute resources.

Liability Risks and Protections for Health Care Practitioners

As noted above, liability exposure is a prominent concern among health care practitioners and entities. The implementation of CSC is a dynamic process that entails difficult decisions, intense trade-offs, constant assessments of specific courses of action, and potentially unconventional acts (including denying or withdrawing health care services because of limited resources). Virtually any patient may feel aggrieved by failing to receive state-of-the-art medical care during an emergency that would have been provided in routine health care environments. Against this backdrop, the potential arises for legal action resulting from perceived or actual denial or limitation of health care services during a crisis. High-profile cases involving health care practitioners responding during Hurricane Katrina, for example, have garnered national attention.11Potential liability claims can result from alleged civil, criminal, and constitutional violations by health care practitioners, volunteers, and government or private entities (Hodge et al., 2009). Liability may stem from claims of medical malpractice, discrimination, invasions of privacy, or violations of other state and federal statutes (e.g., the Emergency Medical Treatment and Active Labor Act [EMTALA]).12 Recently, Tenet Health Systems, which operated Memorial Medical Center in New Orleans, settled claims brought by Hurricane Katrina victims for $25 million. The victims’ claims entailed negligence not only for Tenet’s failure to respond, but also for its failure to plan and prepare properly for the emergency itself (Hodge and Brown, 2011). Such cases reaffirm the essential role of advance planning and preparedness activities in mitigating, at least in part, prospective liability claims.

While not all legal causes of action are viable or proliferate, health care practitioners and entities remain apprehensive about their potential exposure to liability risks especially during emergencies, when their actions and responsibilities may exceed the norm. After the unsuccessful indictment in 2006 of Dr. Anna M. Pou and other health care personnel on criminal charges related to their handling of several patients at Memorial Medical Center during Hurricane Katrina, the AMA, the Louisiana State Nurses Association, and other organizations expressed concern that the case would cause practitioners to reconsider whether to help people during disasters (Jervis, 2007). In developing additional guidance for the implementation of CSC, the committee heard directly from numerous state and local public health and emergency management representatives about their concerns regarding how liability risks may impact the willingness of practitioners and volunteers to participate in emergency response efforts. In addition to numerous anecdotal accounts documented by the committee and other credible sources, some empirical data support similar findings.

In 2006 the Community Health Planning and Policy Development Section of the American Public Health Association (APHA) conducted an electronic survey of prospective volunteer health practitioners. More than 1,000 responses were received. When asked, as a potential volunteer, “how important is your immunity from civil lawsuits in deciding whether to volunteer during emergencies,” almost 70 percent of respondents indicated it was “important” (35.6 percent) or “essential” (33.8 percent) (Carpenter et al., 2008). A survey of 1,057 prospective Medical Reserve Corps (MRC) volunteers in Hawaii, published in 2008, found that liability protections were among respondents’ primary concerns during operations (Quereshi et al., 2008). Concerns regarding liability risks (among others) also are noted in another study of prospective MRC volunteers conducted in 2007 (Schechter, 2007). A 2009 qualitative study of UK health care workers’ willingness to respond during an influenza pandemic (conducted after substantial inquiries following the London bombings in 2005) found “both clinical and non-clinical participants were worried about being asked to perform a role they had not been trained for, and had concerns both about being a danger to patients and being subject to litigation if something went wrong…. It was clear that many participants would be reluctant to take on extended roles without some assurance that they would be protected from litigation [emphasis added] (Ives et al., 2009).

Despite liability concerns during emergencies, there are no comprehensive national liability protections for health care practitioners or entities in all settings. Instead, an array of liability protections at all levels of government covers practitioners and entities—particularly volunteers and government entities and officials—that act in good faith and without willful misconduct, gross negligence, or recklessness (Hoffman, 2008; Hoffman et al., 2009; Rosenbaum et al., 2008; TFAH, 2008). Similar to protections bestowed upon emergency managers, police, firefighters, and other responders, emergency liability protections in all states may immunize or indemnify public health and health care actors or entities from specific claims or monetary damages. Federal or state suspensions of legal requirements or waivers of sanctions for failing to comply with certain federal or state statutes during declared emergencies may offer additional protections.13 Some liability protections, including Good Samaritan statutes (HHS ASPR, 2009), volunteer protection acts,14,15 and tort claims acts,16 may apply outside of an emergency declaration. Other protections, such as those pursuant to EMAC17 or emergency laws, are triggered only by an emergency declaration (Centers for Law and the Public’s Health, 2004). Table 3-2 lists specific statutory or regulatory language that currently provides various levels of liability protection for health care practitioners, volunteers, and entities.

TABLE 3-2. Selected Statutory and Regulatory Health Care Liability Protections in Emergencies.

TABLE 3-2

Selected Statutory and Regulatory Health Care Liability Protections in Emergencies.

Specific federal declarations provide targeted liability protections and authorize the emergency use of medical countermeasures needed for a response. For example, the federal Public Readiness and Emergency Preparedness (PREP) Act18 provides strong liability protections for individuals and entities implementing certain covered medical countermeasures (i.e., countermeasures that are Food and Drug Administration [FDA]-approved, authorized for investigational use, or authorized by an emergency use authorization [EUA]) (Binzer, 2008). Upon a PREP Act declaration by the Secretary of HHS, limited protection from tort liability is extended to “covered persons” (e.g., the United States, manufacturers of the countermeasures, drug distributors, pharmacies, state and local program planners) involved in the development, distribution, and administration of the medical countermeasure(s).19 The act expressly establishes a compensation fund for individuals injured as a result of the administration or use of covered countermeasures (HRSA, 2005). PREP Act liability protections, however, are limited. They apply only to persons and covered countermeasures specified by HHS: one lower court decision in New York, currently on appeal, suggests that the PREP Act liability protections do not immunize a school system or health practitioner involved in allegedly “bad faith” administration of the H1N1 vaccine to a minor student whose parents did not provide their consent.20 PREP Act declarations also are effective only for a specified period of time; however, the effective date of a declaration can precede the date of issue (see, for example, HHS, 2007, issued February 1, 2007, but effective from December 1, 2006). This can be done at the discretion of the Secretary of HHS to extend liability protections to covered persons acting in response to a disaster but prior to a PREP Act declaration.

Liability protections may also be extended through the federal emergency allowance of specific drugs or other medical products that might otherwise be unavailable to the public. When the requisite emergency determination is in place (i.e., by the Secretary of HHS, the Department of Homeland Security [DHS], or the Department of Defense), the Secretary of HHS may declare an emergency justifying the authorization of emergency use for certain medical products. The FDA then can issue an EUA to allow the emergency use of drugs or other medical products that are either (1) not yet approved by the FDA for use or (2) sought for an unapproved use.21 EUAs were issued, for example, during the 2009 H1N1 pandemic to allow unapproved uses of zanamivir (Relenza®) and oseltamivir (Tamiflu®) for treatment and prophylaxis of young children and hospitalized patients (CDC, 2010). To issue an EUA, the Commissioner of the FDA must conclude that

  • the agent specified in the declaration poses the risk of a serious or life-threatening disease or condition;
  • it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the agent;
  • the known and potential benefits of use of the product outweigh the known and potential risks; and
  • no adequate, approved, and available alternative to the product exists to address the agent.22

EUAs remain in effect for the duration of the emergency declaration (up to 1 year unless revoked). Both the declaration and EUAs issued under the declaration may be renewed if justified (FDA, 2009), as was the case with the antimicrobial doxycycline for prophylaxis of inhalational anthrax.23

Once issued, EUAs take effect nationally irrespective of any additional state legal action in support of the authorization (FDA, 2007). The Commissioner of the FDA can set conditions on activities under an EUA to protect the public’s health, including ensuring that health care professionals and patients are informed of risks, benefits, and alternatives and that adverse events are monitored through manufacturers, health care entities, or public health authorities.24 From a liability perspective, EUAs allow the temporary use of a drug or product that would otherwise be prohibited, thus mitigating potential claims related to the unwarranted dispensing of unapproved drugs or other issues.

Although lacking consistency across all emergency responders and entities, the existing patchwork of liability protections can facilitate emergency planning and response efforts by providing assurances of liability protection against negligence claims during and after declared emergencies. These laws collectively provide an umbrella of protections covering hundreds of thousands of practitioners, volunteers, and entities that are expected or asked to play critical roles in emergency response. Yet there are significant limits to liability protections overall. As noted above, some legal protections cover individuals or entities only for their acts during declared emergencies, and the effective date of a declaration of emergency may precede the actual date of the declaration. HHS’s declarations pursuant to the PREP Act, for example, may be retroactive. In most cases, however, liability and other protections emanating from emergency declarations commence only on the date of the declaration and end the moment the declaration is terminated. This may leave some responders whose efforts precede or exceed the time period of the formal declaration unprotected.

Even when liability protections do apply, virtually none of the protections immunize or indemnify practitioners or entities for acts that constitute gross negligence, willful or wanton misconduct, or crimes. Volunteers seeking protection may have to be registered with government or private systems (Hoffman et al., 2009), follow government disaster plans or protocols, or act specifically under government authority.25,26 Liability protections for volunteers do not similarly immunize health care employees working alongside them (some of whom may be covered by medical malpractice insurance subject to insurers’ exceptions), although some states also immunize compensated workers.27,28 Liability protections for health care entities, including hospitals, clinics, pharmacies, and others, are more limited than individual protections.29

Health care practitioners may also be concerned about whether malpractice and other forms of insurance will cover unintentional errors or care given outside a provider’s scope of practice under CSC. In the APHA survey noted above, prospective volunteer respondents were asked, “As a clinician, to what degree does knowing that you have medical malpractice insurance coverage influence your decision to travel out of state to volunteer in a clinical capacity during an emergency?” Nearly 60 percent of respondents indicated such coverage was “important” (24.3 percent) or “essential” (35.4 percent) (Carpenter et al., 2008). While malpractice insurance coverage differs across states and is dependent on specific insurance policy language, plans may not cover a practitioner’s or volunteer’s actions during a declared emergency if they fall outside the individual’s normal scope of activities. To protect volunteers and other health care practitioners from rate increases following frivolous malpractice claims, Delaware state law restricts medical malpractice insurance carriers from increasing the premiums of health care practitioners for their acts or omissions in providing relief care in declared emergencies.30

Ultimately, health care practitioners, volunteers, and entities, in collaboration with emergency managers, legal representatives, and policy makers, should assess the gamut of legal liability protections in their jurisdictions and determine whether additional protections are needed to facilitate the implementation of CSC. Depending on their analyses, gaps may be addressed through existing models for legislative or policy reform (e.g., Model State Emergency Health Powers Act, Uniform Emergency Volunteer Health Practitioners Act), as well through real-time efforts to issue emergency orders, waive liability claims, or ensure malpractice coverage for claims that may arise.

Balance Between Individual Legal Rights and Responsibilities and Communal Objectives

At the core of emergency-related legal issues is the need to balance individual and communal interests to protect the public’s health. Balancing respective legal interests in emergencies is complex. The interests of individuals and the community may conflict, leading to difficult issues in the establishment and implementation of CSC. Due process and other constitutional protections may differ among autonomous adults and children or other wards of the state (e.g., prisoners, persons lacking mental competence) (Gostin, 2008). Nonautonomous individuals may enjoy special constitutional protections intended to prevent individual harms. For example, government may be legally required to protect the health of minors (Courtney and Hodge, 2011) or other “wards,” even though autonomous adults may not be similarly protected (Hodge, 2009).

The Constitution affords everyone procedural due process protection if the state deprives an individual of a “liberty” interest. During a public health emergency, health professionals will have to make difficult decisions to allocate scarce medical resources (O’Callaghan, 2008).31 It is unclear whether a decision to withdraw or withhold certain treatment during an emergency would trigger due process protection. Even if individuals were entitled to some fair process, the Supreme Court has made clear that due process is a flexible concept that may entail a hospital-based impartial review of the facts under the applicable standards of care.32

Individual privacy interests also should be assessed against the need for government or others to provide adequate care or share identifiable health data for public health reporting, research, or other communal purposes (Hodge et al., 2004). Decisions concerning standards of care that disproportionately affect individuals on grounds of ethnicity, religion, race, or other protected characteristics may raise claims of violation of equal protection (Congressional Research Service, 2009).

SUMMARY

In summary, numerous critical issues of law and policy relate to the development and implementation of CSC. Emergency planners, public health officials, and others working within state and local governments and private-sector entities to plan for (or execute) CSC in declared emergencies should (1) be highly knowledgeable about prevalent legal concerns, (2) objectively evaluate the need for legal or policy changes or clarification, and (3) generate meaningful legal solutions in advance of and during emergencies to facilitate real-time implementation of CSC. This may include instituting reforms to provide enhanced liability protection for health care workers, volunteers, and entities working to implement CSC, depending on the policy objectives and preferences within their jurisdictions.

REFERENCES

  • ABA (American Bar Association). American Bar Association House of Delegates: Delegate Handbook. Chicago, IL: ABA; 2011. Report to the House of Delegates Resolution 125 (revised August 6, 2011). In. http://www​.americanbar​.org/content/dam/aba​/administrative/house_of_delegates​/final​_new_delegate_handbook_2011_2012​.authcheckdam.pdf (accessed February 29, 2012)
  • AHRQ_(Agency for Healthcare Research and Quality). Altered standards of care in mass casualty events: Bioterrorism and other public health emergencies. Rockville, MD: AHRQ.; 2005. Publication no. 05-0043.
  • AMA (American Medical Association). House of Delegates Resolution 803: Emergency preparedness. Dallas, TX: AMA.; 2005.
  • AMA. Basic Disaster Life Support Manual Version 2.6. Chicago, IL: AMA.; 2007.
  • AMA. House of Delegates Resolution 206: Uniform Emergency Volunteer Health Practitioners Act. Chicago, IL: AMA.; 2008.
  • Annas G. J. Standard of care—in sickness and in health and in emergencies. New England Journal of Medicine. 2010;362:2126–2131. [PubMed: 20519685]
  • Binzer P. The PREP Act: Liability protection for medical countermeasure development, distribution, and administration. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 2008;6(4):293–298. [PubMed: 19117428]
  • Carpenter M., Hodge J. G., Pepe R. Deploying and using volunteer health practitioners in response to emergencies: Proposed uniform state legislation provides liability protections and workers’ compensation coverage. American Journal of Disaster Medicine. 2008;3(4):17–23. [PubMed: 18450275]
  • CDC (Centers for Disease Control and Prevention). Termination of the Emergency Use Authorization (EUA) of medical products and devices. 2010. http://www​.cdc.gov/h1n1flu/eua/ (accessed September 5, 2011)
  • CDC. Mutual aid. 2011. http://www2a​.cdc.gov/phlp/mutualaid/ (accessed August 20, 2011)
  • Centers for Law and the Public’s Health. The Model State Emergency Health Powers Act (2001). 2001. http://www​.turning-pointprogram​.org/Pages​/pdfs/statute_mod/phsm_emergency_law​.pdf (accessed August 23, 2011)
  • Centers for Law and the Public’s Health. Public health emergency legal preparedness checklist. Civil legal liability and public health emergencies. 2004. http://www​.publichealthlaw​.net/Resources​/ResourcesPDFs/Checklist%203.pdf (accessed February 29, 2012)
  • Centers for Law and the Public’s Health. Hurricane Katrina response: Legal protections for intermittent disaster response personnel under a Federal Declaration of Public Health Emergency. 2005. http://www​.publichealthlaw​.net/Research/PDF​/Katrina%20-%20Federal​%20PH%20Dec%20and%20IDRP.pdf (accessed February 29, 2012)
  • Christian M.D., Hawryluck L., Wax R. S., Cook T., Lazar N. M., Herridge M. S., Muller M. P., Gowans D. R., Fortier W., Burkle F. M. Development of a triage protocol for critical care during an influenza pandemic. Canadian Medical Association Journal. 2006;175(11):1377–1381. [PMC free article: PMC1635763] [PubMed: 17116904]
  • Congressional Research Service. The 2009 influenza A(H1N1) outbreak: Selected legal issues. Washington, DC: Library of Congress; 2009.
  • Courtney B., Hodge J. G. Legal considerations during pediatric mass critical care events. Pediatric Critical Care Medicine. 2011;12((6)):S152–S156. [PubMed: 22067924]
  • Courtney B., Morhard R., Bouri N., Cicero A. Expanding practitioner scopes of practice during public health emergencies: Experiences from the 2009 H1N1 pandemic vaccination efforts. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 2010;8(3):223–231. [PubMed: 20825333]
  • Curie J., Crouch R. How far is too far? Exploring the perceptions of the professions on their current and future roles in emergency care. Emergency Medicine Journal. 2008;25:335–339. [PubMed: 18499814]
  • Devereaux A. V., Dichter J. R., Christian M. D., Dubler N. N., Sandrock C. E., Hick J. L., Powell T., Geiling J. A., Amundson D. E., Baudendistel T. E., Braner D. A., Klein M. A., Berkowitz K. A., Curtis J. R., Rubinson L. Definitive care for the critically ill during a disaster: A framework for allocation of scarce resources in mass critical care. From a Task Force for Mass Critical Care summit meeting, January 26-27, 2007. Chicago, IL: Chest. 2008;133((Suppl. 5)):S51–S66. [PubMed: 18460506]
  • Dobbs D. The Law of Torts. St. Paul, MN: West Group; 2000.
  • FDA (Food and Drug Administration). Guidance—emergency use authorization of medical products. 2007. http://www​.fda.gov/RegulatoryInformation​/Guidances/ucm125127.htm#preemption (accessed September 5, 2011)
  • FDA. Emergency use authorizations questions and answers. 2009. http://www​.fda.gov/NewsEvents​/PublicHealthFocus/ucm153297​.htm (accessed September 5, 2011)
  • GAO (Government Accountability Office). Emergency preparedness: States are planning for medical surge, but could benefit from shared guidance for allocating scarce medical resources. 2008. http://www​.gao.gov/new.items/d08668.pdf (accessed August 23, 2011) GAO-08-668.
  • Gostin L. O. Public health law: Power, duty, restraint, 2. Berkeley, CA: University of California Press.; 2008.
  • HHS (Department of Health and Human Services). Pandemic Countermeasures; Declaration Under the Public Readiness and Emergency Preparedness Act. Federal Register. 2007;72((21)):4710–4711. http://edocket​.access​.gpo.gov/2007/E7-1635.htm (accessed February 13, 2012)
  • HHS ASPR (Department of Health and Human Services Assistant Secretary for Preparedness and Response). Washington, DC: HHS; Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP): Legal and regulatory issues. 2009;184:1.
  • Hick J. L., Barbera J. A., Kelen G. D. Refining surge capacity: Conventional, contingency, and crisis capacity. Disaster Medicine and Public Health Preparedness. 2009;3((Suppl. 2)):S59–S67. [PubMed: 19349869]
  • Hodge J. G. The legal landscape for school closures in response to pandemic flu or other public health threats. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 2009;7(1):45–50. [PubMed: 19379102]
  • Hodge J. G., Anderson E. D. Principles and practice of legal triage during public health emergencies. New York University Annual Survey of American Law. 2008;64(2):249–291.
  • Hodge J. G., Brown E. F. Assessing liability for health care entities that insufficiently prepare for catastrophic emergencies. Journal of the American Medical Association. 2011;306:308–309. [PubMed: 21771993]
  • Hodge J. G., Brown E., O’Connell J. The HIPAA privacy rule and bioterrorism prevention, planning, and response. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 2004;2(2):73–80. [PubMed: 15225400]
  • Hodge J. G., Anderson E., Gable L. A., Vernick J. V., Teret S. P. Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP): Legal and regulatory issues. Washington, DC: HHS; 2008. pp. 1–187.
  • Hodge J. G., Garcia A. M., Anderson A. D., Kaufman T. Emergency legal preparedness for hospitals and health care personnel. Disaster Medicine and Public Health Preparedness. 2009;3((Suppl. 1)):S37–S44. [PubMed: 19491586]
  • Hoffman S. Responders’ responsibility: Liability and immunity in public health emergencies. Georgetown Law Journal. 2008;96:1913.
  • Hoffman S., Goodman R. A., Stier D. D. Law, liability, and public health emergencies. Disaster Medicine and Public Health Preparedness. 2009;3(2):117–125. [PubMed: 19092672]
  • HRSA (Health Resources and Services Administration). Countermeasures Injury Compensation Program. 2005. http://www​.hrsa.gov/gethealthcare​/conditions​/countermeasurescomp/ (accessed February 1, 2012)
  • Ives J., Greenfield S., Parry J. M., Draper H., Gratus C., Petts J. I., Sorell T., Wilson S. Healthcare workers’ attitude to working during pandemic influenza: A qualitative study. BMC Public Health. 2009;9:56–69. [PMC free article: PMC2654560] [PubMed: 19216738]
  • Jervis R. USA Today. 2007. Charges against La. doctor dropped. http://www​.usatoday.com​/news/nation/2007-07-24-katrina_N.htm (accessed August 23, 2011)
  • Kanter R. K. Strategies to improve pediatric disaster surge response: Potential mortality reduction and tradeoffs. Critical Care Medicine. 2007;35:2837–2842. [PubMed: 17901842]
  • Mastroianni A. C. Liability, regulation and policy in surgical innovation: The cutting edge of research and therapy. Health Matrix. 2006;16:351–442. [PubMed: 16948248]
  • O’Callaghan, N. Dying for due process: The unconstitutional medical futility provision of the Texas Advance Directives Act. Baylor Law Review. 2008;60(527):587.
  • Pegalis S. E. Physician and surgeon liability: Standard of care, generally. American Law of Medical Malpractice. 2009;3((3))
  • Quereshi K., Gershon R. M., Conde F. Factors that influence Medical Reserve Corps recruitment. Prehospital and Disaster Medicine. 2008;23((3)):s27–s34. [PubMed: 18702285]
  • Rosenbaum S., Harty M. B., Sheer J. State laws extending comprehensive legal liability protections for professional health-care volunteers during public health emergencies. Public Health Reports. 2008;123:238–241. [PMC free article: PMC2239336] [PubMed: 18457079]
  • Schechter S. Medical Reserve Corps volunteers’ ability and willingness to report to work for the Department of Health during catastrophic disasters. 2007. PhD diss., Naval Postgraduate School.
  • TFAH (Trust for America’s Health). TFAH liability protections relevant statutes. 2008. http:​//healthyamericans​.org/reports/bioterror08​/pdf/legal-preparedness-law-review-of-state-statutes-and-codes.pdf (accessed February 1, 2012)
  • Wise E. Competence and scope of practice: Ethics and professional development. Journal of Clinical Psychology. 2008;64:626–637. [PubMed: 18384117]

Footnotes

1

Note that medical standards of care should not be confused with a health care provider’s scope of practice or associated privileges (Curie and Crouch, 2008; Pegalis, 2009). Scope of practice refers to the extent of a licensed professional’s ability to provide health services in accordance with his or her competence and license, certification, privileges, or other authority to practice (AHRQ, 2005; Wise, 2008).

2

Hood v. Phillips, 554 S.W.2d 160, 165 (Tex. 1977).

3

Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974).

4

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

5

The American Bar Association’s House of Delegates has expressed opposition to the adoption of laws that “would alter the legal duty of reasonable care in the circumstances owed to victims of a natural or manmade disaster by relief organizations or health care practitioners.” It suggests that the flexible nature of the legal standards of care provides adequate assurance of protection from unwarranted liability claims without the need to deny patients their right to bring claims through immunity protections.

6

“RESOLVED, That our American Medical Association support the enactment in state legislatures of the National Conference of Commissioners on Uniform State Laws [NCCUSL] Uniform Emergency Volunteer Health Practitioners Act with the liability language of Alternative A as formally adopted by the NCCUSL in August 2007.”

7

While many states may have authorities to declare states of “public health emergency,” the following states have authorities based on the Model State Emergency Powers Act: Alabama, Arizona, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, New Jersey, New Mexico, North Carolina, Oklahoma, Oregon, South Carolina, South Dakota, Texas, Virginia, Washington, Wisconsin, and Wyoming.

8

The Commonwealth of Virginia provides immunity protections for health care practitioners during resource-scarce disasters following the declaration of a state or local emergency. “In the absence of gross negligence or willful misconduct, any health care provider who responds to a disaster shall not be liable for any injury or wrongful death of any person arising from the delivery or withholding of health care when (i) a state or local emergency has been or is subsequently declared in response to such disaster, and (ii) the emergency and subsequent conditions caused a lack of resources, attributable to the disaster, rendering the health care provider unable to provide the level or manner of care that otherwise would have been required in the absence of the emergency and which resulted in the injury or wrongful death at issue.” Code of Virginia § 8.01225.02 (2008).

9

Louisiana Senate Bill No. 301, SB 301, 2008 Regular Session, Louisiana Legislature, Act No. 538 (June 30, 2008), http://www​.legis.state​.la.us/billdata/streamdocument​.asp?did=503696 (accessed February 1, 2012).

10

Public Law 104-321. EMAC was approved by Congress in 1996. All states, the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands have enacted EMAC legislation.

11

The most publicized case of criminal liability associated with a health care professional’s decisions during a resource-scarce situation is that of Dr. Anna Pou, a physician from Memorial Medical Center in New Orleans. Dr. Pou was charged with second-degree murder for allegedly hastening the deaths of several patients during Hurricane Katrina. While she was not criminally indicted, she also faced several civil wrongful death claims. In response, Louisiana enacted civil liability immunity protection laws aimed at protecting health care workers who act in good faith during emergencies. See, e.g., Louisiana Senate Bill No. 301, Act No. 538 (2008).

12

The Emergency Medical Treatment and Active Labor Act (EMTALA), 42 U.S.C.A. § 1395dd (1986). EMTALA, for example, requires hospitals that participate in Medicare and have a dedicated emergency department to provide a medical screening examination within their capability to individuals who report to the emergency department and request such an examination or treatment for a medical condition. EMTALA also includes requirements for stabilizing and transferring patients. Physicians and health care entities that negligently fail to comply with EMTALA may be excluded from participation in the Medicare program and incur monetary penalties.

13

42 U.S.C. § 1320b-5 (2008). Under section 1135 of the Social Security Act, the Secretary of HHS may temporarily waive or modify certain program requirements for Medicare, Medicaid, and the State Children’s Health Insurance Program. For example, sanctions for failing to comply with certain EMTALA requirements may be waived by the Secretary during public health emergencies.

14

Public Law 105-19; 42 U.S.C. § 14501 et seq. All states and the District of Columbia have adopted state volunteer protection acts.

15

The Uniform Emergency Volunteer Health Practitioners Act (UEVHPA) was developed in 2007 in response to a lack of uniformity in states’ protections for medical and other volunteers. It “establishes a system whereby health professionals may register either in advance of or during an emergency to provide volunteer services in an enacting state. Registration may occur in any state using either governmentally established registration systems, such as the federally funded ‘ESAR VHP’ [Emergency System for Advance Registration of Volunteer Health Professionals] or Medical Reserve Corps programs” (http://www​.uevhpa.org/DesktopDefault​.aspx).

16

Under the Federal Tort Claims Act, for example, a “covered employee [is] not personally liable for negligent acts committed within [the] scope of Federal employment” (HHS, Federal Public Health Emergency Law: Implications for State and Local Preparedness and Response [teleconference], April 28, 2009).

17

“Under EMAC, a person from one state who renders assistance in another and who holds a license, certificate, or other permit for the practice of professional, mechanical, or other skills is considered to be licensed, certified, or permitted to exercise those duties in the requesting state, subject to limitations or conditions set by the requesting state’s Governor.” Still, licensure reciprocity is not automatically extended to volunteer health care practitioners who do not provide services pursuant to an EMAC request for assistance (Congressional Research Service, 2009).

18

42 U.S.C. § 247d-6d.

19

“Countermeasures covered under a PREP Act declaration include products that are approved, cleared, or licensed under the FD&C [Food, Drug, and Cosmetics] Act or the PHS [Public Health Service] Act, authorized for investigational use under the FD&C Act, or authorized under an EUA. For example, if a person is given a countermeasure that is lawfully authorized for emergency use under an EUA, that person may be eligible under the PREP Act for compensation through the CICP [Countermeasures Injury Compensation Program] if serious physical injury or death results from use of the countermeasure.” See http://www​.fda.gov/EmergencyPreparedness​/Counterterrorism/ucm269226​.htm#prepcoverage.

20

Parker v. St. Lawrence County Public Health Department, No. 44-1-2011-0204 (Sup. Ct. N.Y. St. Lawrence County decided July 5, 2011) (unpublished decision).

21

Project Bioshield Act of 2004, Public Law 108-276, § 564(a)-(b).

22

Project Bioshield Act of 2004, Public Law 108-276, § 564(c). For more information on how these determinations are to be made and what information is included in a request for EUA consideration, see FDA guidance on EUAs (http://www​.fda.gov/RegulatoryInformation​/Guidances/ucm125127.htm#intro).

23

76 FR 44926. HHS’s declaration justifying the emergency use of doxycycline hyclate tablets accompanied by emergency use information was originally issued in 2008 and subsequently renewed in 2009 and 2010 in response to continuing national security concerns. The declaration was also renewed and amended in 2011. An EUA (issued under that declaration) for doxycycline hyclate tablet emergency kits for U.S. Postal Service participants and their household members was originally issued in 2008 and subsequently amended in 2009, 2010, and 2011.

24

Project Bioshield Act of 2004, Public Law 108-276, § 564(e).

25

For example, under HHS’s National Disaster Medical System, “an individual appointed under paragraph (1) shall, while acting within the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to the participation of individuals appointed under paragraph (1) in training programs authorized by the Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this section, acts of individuals so appointed that are within the scope of such participation shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the individuals receive compensation for such participation).” 42 USC § 300HH-11.

26

“Intermittent disaster-response personnel benefit from the same immunity from civil liability granted to employees of the U.S. Public Health Service. The only remedy for damages for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions by any commissioned officer or employee of the Public Health Service (acting within the scope of office or employment) is against the United States, and not against the officer or employee (or her estate) whose act or omission gave rise to the claim. The U.S. Attorney General is also required to defend these individuals” (Centers for Law and the Public’s Health, 2005).

27

Code of Virginia § 8.01225.02 (2008).

28

Louisiana Senate Bill No. 301, Act No. 538 (2008).

29

Entities may also be covered under state liability protection laws for Good Samaritan entities during emergencies. However, most state Good Samaritan laws leave significant gaps of liability exposure for both private and nonprofit organizations that are willing to assist government agencies voluntarily in responding to emergencies. As a result, at least 28 states and the District of Columbia have developed specific emergency liability protections for business and nonprofit organizations that act in good faith to assist government agencies voluntarily during emergencies. See, e.g., Louisiana House Bill 554 (2009) RS 29:735.3.1 (http://www​.legis.state​.la.us/billdata/streamdocument​.asp?did=662505).

30

“No act or omission of qualified medical personnel during such relief operations and activities shall affect an insured physician’s liability coverage in any way.” Del. Code Ann. tit. 20, § 3129(b) (TFAH, 2008, p. 26).

31

“By its terms the due process clause applies to particularized governmental decisions about whether an individual is to be granted a benefit or to be subjected to a burden” (O’Callaghan, 2008).

32

In ascertaining the due process procedures that are constitutionally required, the courts weigh three factors—the extent of the deprivation of liberty or property, the risk of an erroneous decision, and the burdens that additional procedures will entail. Thus, the procedures in any given circumstance depend on the public health context and vary from case to case. The process required can range from a full-blown hearing to an informal, nonadversarial review (Gostin, 2008). In Parham v. J.R., for example, the Supreme Court ruled that the state did not have to provide a formal hearing. Since juvenile admission to a mental hospital was “essentially medical in character,” an independent review by hospital physicians was sufficient for due process purposes. Parham v. J.R., 442 U.S. 584, 609 (1979) (holding juvenile commitment decision when made by a “neutral factfinder” sufficient to satisfy due process requirements).

Copyright 2012 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK201075

Views

  • PubReader
  • Print View
  • Cite this Page
  • PDF version of this title (8.4M)

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...