In the beginning, it will be smaller than the human eye can see, but it will have the power to bring down nations, disrupt global economic systems and delay the advance of civilization. Whether the source is a naturally occurring mutation or a weaponized form of an agent already on laboratory shelves, the impact of this bioviolence will be much the same. The question for lawyers, policymakers and politicians is, “Ready to wrestle?”

“For those who still believe that the next pandemic simply will not occur or will be far more adequately and easily handled than previous pandemics because of our modern health care system, think again,” Michael Osterholm wrote in “Community Pan-Flu Preparedness: A Checklist of Key Legal Issues for Healthcare Providers.” Osterholm, a leading voice on the issues of pandemic influenza preparation and bioterrorism, is director of the Center for Infectious Disease Research and Policy, associate director of the Department of Home­land Security’s National Center for Food Protection and Defense, and a professor at the University of Minnesota’s School of Public Health.

The Coming Crisis

In the past decade, bioterrorism, fear of global influenza pandemics and biological crises have popped up on the radar and then faded into the background. Flurries of preparation focused on the threat of bioterrorism and the next flu pandemic, which experts agreed was past due. As these plans have been put in place, many of the tactical pieces are being resolved but serious legal and ethical questions remain in responding to incidents of bioviolence. Whether the response is to an act of nature or some form of bioterrorism, the problems are similar.

One thing that Osterholm and other experts agree on is that the scale of a major biological crisis will test the United States in a way in which it is unprepared.

“Anyone who is familiar with the United States health care system today realizes that as much as any institution in modern society, it represents an intersection of technology, innovation, healing, crisis, chaos, outcome measurement, unintentional injury, ethics and serious financial challenge – all in one package,” Osterholm said.

Where major natural disasters tend to be regional in scope, a biological crisis could be global. As devastating as Hurricane Katrina was, regional help was available. Refugees and those affected by the storm could move to neighboring states, and health care officials from unaffected areas could be redirected. In a global bioviolence crisis, help may not be just a state away, and in many cases travel may be restricted.

The time span of a major event is likely to be a factor. An infectious agent could round the globe in a series of months, maintaining high intensity for 18 to 24 months as opposed to the 18 to 24 hours it takes for a natural disaster to occur.

A major modern bioviolence incident would take place in a world that is uniquely built to encourage global proliferation. The United States operates in a “just-in-time” economy that would be affected by a worldwide bioviolence incident. “We live in a world where many of the critical products that we count on every day arrive by fast freighter from Asia and are delivered to our hospitals, businesses and homes just in time,” Osterholm explained. Reporters Bernard Wyoscoki Jr. and Sara Lueck of The Wall Street Journal explained it this way, “The very rules of capitalism that make the U.S. an ultra-efficient marketplace also make it exceptionally vulnerable in a pandemic.” The vegetables that will be in the supermarket a month from now are likely still in the field a continent away. Wyoscoki and Lueck noted that most hospitals hold only a 30-day supply of drugs, and beyond the medical implications, the just-in-time model applies to everything from food to fuel.

Osterholm noted, “Frankly, the collateral morbidity and mortality from such medication shortages could be huge.”

Global trade routes are extremely efficient in transporting goods, but they also are extremely efficient in transporting disease. It is the ultimate paradox. The United States may need a vaccine or even something as basic as more surgical masks from China or India, but may fear the spread of infection from those who must transport them.

Legal Questions

The legal questions posed by responding to an actual incident of bioviolence are numerous and largely unexplored. Those concerned about individual civil rights, the legal system and policy should be preparing now for what most experts agree is the inevitable.

The consequence of not planning now could be catastrophic; the legal and policy questions at the height of the crisis could be just as overwhelming as the medical questions. N. Pieter M. O’Leary in the Health Matrix: Journal of Law Medicine said, “Effectively combating infectious disease outbreaks requires balancing legal controls and civil liberties. Without a balance, individuals and nations alike disregard the law in pursuit of their own interests.”

Combating bioviolence is a team effort on a grand scale. The Severe Acute Respiratory System (SARS) outbreak of 2002 is credited as the first truly global infectious disease (but not considered a pandemic) of the 21st century. According to O’Leary, “The outbreak stressed the importance of global cooperation, and raised questions of how to balance public health concerns with respect for individual rights.”

The Impact on Individuals

Many of the things that people consider part of their basic human rights – and some areas that we take for granted in terms of medical rights – will be tested during a major incident of bio- violence. Individuals would likely be called on to make many decisions for the good of the community that may test their own goodwill and, in turn, test the regulatory and enforcement tools in place.

Quarantine is an issue that will bring significant legal questions. “It is not enough to have the legal authority to declare a quarantine. You have to figure out how you would implement and enforce it,” wrote John O. Agwunobi, former assistant secretary for health, U.S. Department of Health and Human Services, in the Journal of Law, Medicine and Ethics. Agwunobi is quick to point out that quarantine may not have to be mandatory to be effective, but stresses the possible need to avoid public gatherings, a basic constitutional right. It is not difficult to imagine a scenario in which a group of individuals who feel that a government response to a bioviolence incident is not appropriate, may want to get together and protest, but the act of gathering may very well endanger them and may be the very thing the government is trying to regulate.

The Spanish Influenza epidemic of 1918-1919 is seen as the last major global pandemic and a model for both the spread of and public reaction to the disease. In 1918 many U.S. cities had laws that required all citizens to wear masks in public to stop the spread of the disease. In San Francisco the public responded by forming the Anti-Masking League. “While many individuals would voluntarily mask themselves, being ordered to purchase and wear a mask is likely to raise constitutional challenges,” O’Leary explained.

Legal challenges also could arise from issues related to health privacy. In the United States, the Health Information Protection Act (HIPA) protects the private data of patients; however, medical data may need to be shared immediately, not just regionally, but possibly internationally. Most states have a Model State Emergency Health Powers Act that authorizes states to share the information.

Health Care Organization Considerations

Lawyers clearly have a role in planning for altered standards of care during a crisis. In the United States, the high standard of care demands the health care community be available to provide service and meet community needs. According to the Community Pan-Flu Preparedness Checklist, planning assumptions suggest that in the case of a significant bioviolence event, hospitals would find it difficult to treat all of the patients who needed care. This does not mean just the patients infected, but all of the other patients who rely on hospitals on a daily basis for cancer treatments, dialysis and emergencies of all kinds.

The Community Pan-Flu Prepared­ness document puts it this way, “Preparing adequately for an influenza pandemic may require health care organizations to overcome their traditional fears of liability and address altered standards of care that may become necessary in an influenza pandemic situation.” The document goes on to say this in even stronger terms regarding individual care giver’s respon­sibilities: “In order to save the most lives, health care providers need to be able to practice under an altered standard of care without fearing traditional civil (and possibly criminal) liability.”

For health care organizations and individuals alike, the legal questions do not stop there. In the case of a major incident, with a system that could not handle the demand, it might become difficult to provide some of the most basic protections that workers expect. The Fair Labor Standards Act, for instance, covers maximum work and overtime requirements. Questions posed by the checklist range from the simple, “Does mandatory quarantine count toward the calculation of compensable hours worked?” to the very complex, “In the event of a major emergency requiring all available personnel to work extended hours, could the good-faith provisions of the Portal-to-Portal Act excuse noncompliance with economically burdensome overtime requirements?”

Ongoing Policy Issues

Beyond the questions of individuals and health care providers, significant policy questions continue to be debated. In a September 2001 New York Times article, “U.S. Germ Warfare Research Pushes Treaty Limits,” reporters Judith Miller, Stephen Engelberg and William Broad revealed several classified U.S. bio- defense projects, including Project Jefferson, which included the reproduction of a vaccine-resistant strain of anthrax. Scholars and others continue to ask if this type of biodefense work isn’t in violation of the 1972 Biological Weapons Convention. In some cases, threat-assessment work requires the building of biological weapons to find appropriate countermeasures. The existence of some of these biological agents, even if slated for defense purposes and research, brings about a host of ethical and legal questions.

In his paper, “United States Biodefense, International Law, and the Problem of Intent,” Dr. Christian Enemark explored several of the issues related to international law. Enemark, from the Australian Defense Force Academy at the University of New South Wales, is a lecturer on global security. “Research and development projects on biological weapons threat-assessment involve experimenting with the offensive applications of pathogens so as to determine appropriate countermeasures,” he said. “However, such projects carry a security risk.” Enemark argued that, by their very nature, threat-assessment projects may be increasing the proliferation of biological weapons worldwide. Other scholars have examined the history of biomedical research and weapons research in the United States and concluded that policymakers have not kept up with the latest advances in these areas.

International relations are another critical policy matter to be addressed in the planning stages. In the journal Foreign Affairs, Osterholm explained the effect of a major outbreak of infection with a 5 percent mortality rate, “Border security would be made a priority, especially to protect potential supplies of pandemic-specific vaccines from nearby desperate countries. Military leaders would have to develop strategies to defend the country and also protect against domestic insurgency with armed forces that would likely be compromised by the disease. Even in unaffected countries, fear, panic and chaos would spread as international media reported the daily advance of the disease around the world. In short order, the global economy would shut down.”Will We Be Found Negligent?

The Community Pan-Flu Preparedness Checklist issued by the American Health Lawyers’ Association and other documents demonstrate that there is ongoing planning in these areas. Dis­cussions continue about the response and what can be done to prevent the spread of infectious disease and to prevent bioterrorism.

The call to the legal community is strong, and is summed up by Osterholm in the checklist: “Make no mistake about it: We will be judged harshly if one day the next pandemic occurs and it was found we were negligent in not better preparing for what was clearly predicted.”

Helping us imagine law practice in an age of bioviolence were our volunteer photo models, Chris Truso (2L) and Nicole Truso (3L).

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