The “war” against terrorism is fraught with inescapable legal and ethical dimensions that evoke heated debate among constitutional lawyers, ethicists, civil libertarians, and the ordinary public. Strong differences of opinion regarding constitutionality of antiterrorism efforts exist as evidenced by the multiple legal challenges being brought against selected elements of the Patriot Act. These conflicts have and will continue to be played out in the area of bioterrorism, particularly the tension between protecting civil liberties and the public’s health. This conflict has a long and fascinating history that has attracted the interest of historians of medicine and public health, as well as legal scholars, novelists, and health policy makers. In Colonial America, for example, medical, religious, and political leaders fought over variolation as a means of stemming smallpox epidemics. Echoes of this debate are evident in the more recent national smallpox vaccination campaign.

Many of these same issues remain today. During the TOPOFF 1 trial (described in Chapter 1), many participants called for imposition of a quarantine when the “plague” breached established perimeters of defense. Post-hoc analyses of TOPOFF 1 found that decision-makers made this recommendation without fully realizing the enormous logistical, ethical, and political dimensions of that decision. Further, it was not at all clear just who had the authority in these circumstances to implement or maintain such a quarantine. How contemporary societies would respond to public health measures (used with far greater frequency historically) is uncertain. For one thing, our experience with quarantine—arguably the most stringent public health control measure—is rather thin. Second, in most, if not all, Western society’s individual liberties are often defended against even the most minor intrusions of the state. For our purposes, it is not feasible or necessary to provide a comprehensive discussion of the legal and ethical aspects of bioterrorism. However, clinicians should be familiar with a few areas relating to public health law which this chapter presents. In addition, using the example of the recent smallpox vaccination program, we hope to illustrate some of the more salient liability issues that are likely to emerge should a bioterrorist attack occur at some point in the future.

Of Note…

Oran, Algeria, 1940s

One of the most striking consequences of the closing of the gates was, in fact, this sudden deprivation befalling people who were completely unprepared for it. Mothers and children, lovers, and husbands and wives who had a few days previously taken it for granted that their parting would be a short one, exchanged a few trivial remarks, sure as they were of seeing each other again after a few days, or at most, a few weeks, duped by our blind human faith in the near future and little if at all diverted from their normal interests by this leave-taking—all these people found themselves, without the least warning, hopelessly cut off, prevented from seeing each other again, or even communicating with each other. . While our townsfolk were trying to come to terms with their sudden isolation, the plague was posting sentries at the gates and turning away ships bound for Oran. No vehicle had entered the town since the gates were closed. . Only a few ships, detained in quarantine, were anchored in the bay. But the gaunt, idle cranes on the wharves, tip-wagons lying on their sides, neglected heaps of sacks and barrels—all testified that commerce, too, had died of the plague . .

—Albert Camus, The Plague

Clinicians may be unaware of the fact that well-established legal precedents give enormous power to state and federal authorities in regards to public health. This legal authority allows governments to institute a wide range of public health control measures, temporarily laying aside existing civil statutes, as part of what is sometimes referred to as the social contract between individual citizens and their government. Put simply, citizens are not entitled to exercise certain individual liberties if doing so threatens the health and welfare of the larger society.

Historically the legal boundaries and jurisdiction for these decisions have been areas of contention; pitting local, state, and federal authorities against one another. Over time, such jurisdictional conflicts have resolved gradually into what we have today. In most states, local public health issues are handled at the local level, and authority to implement public health control measures lies with local municipal health authorities. When these issues cross municipal or county boundaries, state governments assume responsibility. Last, when a public health issue crosses state lines or international borders, the federal government becomes the ultimate authority responsible for public health control measures. As noted earlier, President Clinton signed an Executive Order giving primacy to the CDC to manage all national public health emergencies, with assistance as requested by a number of federal agencies, including FEMA, the FBI, the Department of Defense (DOD), the Federal Aviation Administration (FAA), or any other federal agency whose resources and expertise are requested by the CDC. It is the CDC’s responsibility, for example, to impose national or international travel restrictions in the event of an infectious disease threat, such as occurred with SARS. Similarly, the CDC can mandate the isolation of sick passengers arriving in any U.S. port of call and can restrict the movement of any person who is deemed a potential health threat. This authority extends to U.S. nationals as well as to foreign visitors.

In relation to bioterrorism, these jurisdictional issues have not been fully tested, and it is unclear whether the agreed-on delegation of authority will withstand a genuine bioterrorist threat. Experience to date suggests that confusion and chaos regarding this authority are probable and should be anticipated. Efforts to conduct field tests (like TOPOFF) or “table-top” exercises can help “train up” those involved in bioterrorist response, but they are no substitution for the real thing. Even in these exercises, lines of authority were unclear to many participants and draconian measures—including the decision by Colorado officials to quarantine the entire population (2 million) of Denver—were impossible to implement.

Bioterrorism raises legal and ethical issues that differ fundamentally from past public health issues. Why is this so? Unlike traditional public health threats, bioterrorism is simultaneously a public health issue and a federal crime. Some have argued that bioterrorism is an outright act of war. Viewed either as a criminal act or as an act of war, bioterrorism clearly is a federal responsibility. In contrast, jurisdictional traditions and precedents in public health law have been contingent historically on the nature and locus of the particular threat. Bioterrorism has altered, perhaps irrevocably, the locus of public health authority because it is simultaneously a national security issue—and so the purview of the federal government—and a public health emergency. Addressing the historical tension between state and federal authorities and the fundamental shift in responsibility as a result of the threat of bioterrorism, the noted bioethicist George Annas observed pithily that “the creation of these federal agencies, however, did not alter the state’s responsibility for public health; the anthrax attacks did.”1

Bioterrorism, or, more accurately, legal and regulatory responses to the threat of bioterrorism break new and highly controversial ground in public health law. Well before the September 11 attacks, however, the limitations of existing public health laws to address the modern realities of public health were recognized, and calls for substantive reform were under way. In 1988 and again in 2002, the Institute of Medicine issued two reports calling existing state public health laws antiquated and inconsistent. Among the measures recommended by the Institute of Medicine were the urgent need to revise existing public health statutes so that lines of authority and responsibilities regarding public health were clearly defined, and second to give these organizations the procedural, regulatory, and administrative tools needed to address modern public health threats and emergencies. Notwithstanding the consensus regarding the limitations of existing state and federal public health regulations and laws, what steps are justified to address these deficiencies remains hotly debated. The danger of not clarifying and modernizing existing laws was stated clearly and unambiguously by the legal scholar David Fidler who wrote in 2001 that “the ineffectiveness of existing legal frameworks in a real bioterrorism crisis would exacerbate pressure on governments to take drastic actions that might sweep away the rule of law in the midst of panic and uncertainty.”2

Steps were taken to address the nation’s system of public health law in the aftermath of September 11, including a national multiorganizational public–private collaboration whose charge it was to offer model language with which local, state, and tribal governments could update outdated statutes and regulations. The collaboration included representatives from five states, nine national organizations and government agencies involved in public health (including local, state, federal, and tribal groups), as well as consultants representing legal, public health, and public health law communities. The purpose of this collaboration was to modernize the dated legal framework in order to guide state, local, and tribal governments in their efforts to modernize existing public health statutes and regulations, thereby protecting both public health and national security interests. The original draft model legislation was first promulgated in 2001, and it quickly gained strong supporters and determined critics. Subsequent comments and revisions resulted in changes that have been incorporated into a document released in September 2003, referred to as the Model State Emergency Health Powers Act (MSEHPA).

According to the legislative proposal, MSEHPA “grants public health powers to state and local public health authorities to ensure a strong, effective, and timely planning, prevention, and response mechanisms to public health emergencies (including bioterrorism) while also respecting individual rights.” The most important features of the model law address changes in the public health authority granted to states, designated state public health agencies and officials, and the responsibilities of health care providers, including hospitals, physicians, and other clinical practitioners.

Under MSEHPA, state governors may declare a public health emergency using their executive powers. A public health emergency is defined as the following:

. . an occurrence or imminent threat of an illness or health condition that is believed to be caused by any of the following: (i) bioterrorism; (ii) the appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; or (iii) a natural disaster, a chemical attack or accidental release, or a nuclear attack or accident; and poses a high probability of any of the following harms: (i) a large number of deaths in the affected population; (ii) a large number of serious or long-term disabilities in the affected population; or (iii) widespread exposure to an infectious or toxic agent that poses a significant risk of substantial future harm to a large number of people in the affected population.3

During a declared public health emergency, state governors’ broad powers include calling out the militia, changing state agency functions and authority, and temporarily suspending existing statutes that could, if followed, interfere with actions needed to control a public health emergency.

Earlier versions of the model public health legislation contained particularly contentious language, such as provisions for compulsory testing and compulsory participation by physicians and hospitals. It also included criminal misdemeanor penalties for noncompliance. Comments on the proposal since its initial promulgation resulted in a less controversial version, although this, too, has its share of critics among constitutional scholars, bioethicists, and health care organizations. Critics of the proposal insist that it gives public health officials historically unprecedented powers, far beyond what they possess currently. In the event of a declared public health emergency, for example, the act includes provisions for mandatory treatment by an individual who “has or may have been exposed to a contagious disease” and requires health care providers to inform individuals they are treating about how to prevent further spread of the disease and the need for treatment. Further, health care providers may be required to assist in “vaccination, treatment, examination, testing, decontamination, quarantine, or isolation of any individual as a condition of licensure . . or the ability to continue to function as a health care provider in this state.” In the 2001 version, health care workers, hospitals, and individuals potentially exposed were liable for criminal misdemeanor penalties if they did not abide directives issued by public health authorities to control the disease. In the 2003 proposal, health care workers and hospitals may still suffer consequences for noncompliance, including revocation of state licensure.