JURIST Guest Columnists James G. Hodge, Jr. of the Sandra Day O’Connor College of Law, Arizona State University (ASU), John L. Hick of the University of Minnesota School of Medicine, Dan Hanfling of the UPMC Center for Health Security and Sarah Wetter of the Sandra Day O’Connor College of Law, ASU, discuss the intersection of medical and legal decisions in response to the Zika virus outbreak …

On the heels of the 2014 Ebola outbreak (with just a few remaining cases in Sierra Leone), the world faces its next major threat from an emerging infectious agent—Zika virus (ZIKV). Originally discovered in Uganda in 1947, ZIKV, like Ebola, was largely dormant for decades. Limited outbreaks among smaller populations in the Yap Islands (2007) and French Polynesian Islands (2013) raised some public health flags. However, ZIKV’s emergence in South and Latin Americas in 2015 through global migration of mosquitoes and human travel patterns escalates this threat to emergency levels.

On February 1, 2016, the World Health Organization (WHO) declared the spread of ZIKV a public health emergency of international concern (PHEIC). Multiple countries, including Brazil, Honduras and Mexico, have made similar declarations. The US National Security Council has directed federal agencies to plan for the emerging virus. President Obama presented a supplemental budget to Congress recently focused on improving diagnosis, developing medical countermeasures and coordinating preparedness and response strategies. On February 8, the Centers for Disease Control and Prevention (CDC) placed its emergency operations center on its highest Level 1. Governors of Florida (2/3), Puerto Rico (2/5) [Spanish], and Hawaii (2/12) [PDF] have declared their own states of emergency with the impending approach of ZIKV in the US. ZIKV is projected to infect multiple millions globally before this current wave crests.

As with Ebola, ZIKV requires public health officials, medical practitioners, and policymakers to make critical, real-time decisions with inexact or incomplete data on the morbidity and risks of the condition itself. While Ebola virus disease (EVD) imperiled patients, medical providers, and those immediately around them, impacts of ZIKV are thought currently to extend mostly to vulnerable infants and pregnant women. As discussed below, difficult choices at the intersection of public health, medical and legal triage must be made amidst present and future uncertainties about the trajectory and morbidity of ZIKV among specific populations.

Public Health and Medical Triage In Response to ZIKV
ZIKV is yet another example of an emerging infectious disease with public health consequences exceeding the normal provision of medical care. Unlike with EVD, ZIKV is spread primarily via the Aedes species of mosquitos. Other lesser routes of ZIKV transmission include through infected humans→mosquitoes→other humans, sexual transmission, blood transfusions and potentially even through other bodily fluids (e.g., saliva, urine). None of these other routes is known presently to be the source of major, or even minor, outbreaks. Still, Brazilian authorities recommended that people avoid kissing to prevent infection during the February 2016 Carnival. As well, sexual transmission of the virus from male to female partners for undefined periods of time after the partner’s infection implicates additional medical and societal issues.

Risks. Public health challenges of ZIKV extend from risks primarily to unborn children. Most ZIKV infections occur with minimal or no symptoms to the host (only about 20 percent of infected persons are symptomatic). Its transfer to fetuses through pregnant women, however, can have catastrophic consequences. Microcephaly, in which babies are born with abnormally small heads and brains, has been associated with corresponding increases in rates of fetal demise and moderate to severe developmental delays in the offspring of women infected with ZIKV. When and how often infection in the course of pregnancy may lead to such disabilities are uncertain.

A spectrum of less severe brain damage among infants may also be correlated with ZIKV, but these conditions can only be detected well after birth when cognitive testing can be conducted. Vision and hearing problems among newborns have also emerged as potential ZIKV complications. Some reports in Colombia and elsewhere suggest adults infected with ZIKV develop Guillain-Barre Syndrome (GBS), which can cause temporary or permanent paralysis.

Testing. Several companies are working to develop rapid, easy and accurate tests for ZIKV as existing blood tests are problematic. A PCR test applied during a patient’s symptomatic phase can only be conducted at a handful of specialized laboratories. Patients recovering from ZIKV can also be tested for IgM antibodies [PDF]. Interpretation of the IgM results is confounded by cross-reactivity with other diseases such as Dengue fever and Yellow fever vaccine, commonly recommended for travelers to areas where ZIKV is currently endemic.

Currently CDC recommends testing pregnant women who have traveled to endemic countries, whether or not they experience symptoms of ZIKV. Testing recommendations are problematic. False positive tests [PDF] (where a test inaccurately suggests ZIKV infection) may lead a woman to decide to terminate an otherwise normal, healthy pregnancy. False negative tests (where a test fails to accurately detect infection) are rarer, but may lead to missed diagnoses. Subsequent failures to perform appropriately-timed ultrasounds during pregnancy may result in undetected cases of microcephaly. Finally, while domestic testing demands are being met now, rapidly and accurately testing thousands of at risk pregnant women will be difficult if ZIKV transmission spreads across southern states later this spring.

Preparedness. Public health and medical limitations are compounded by a potential lack of preparedness, as seen with initial cases of EVD in the US. Front line medical providers likely to see cases of ZIKV include specialists in obstetrics/maternal-fetal medicine, primary care, neonatology and neurology. Most of these practitioners have limited experience with preparing for public health emergencies, implementing crisis standards of care and reporting ZIKV cases. Consequently, the Assistant Secretary for Preparedness and Response, CDC, other federal authorities and specialty societies (e.g., American College of Obstetrics and Gynecology) are working extensively to raise awareness of ZIKV, its symptoms and morbidity among the clinical community.

Treatments and Vaccines. There is no specific treatment for ZIKV. Addressing typical symptoms (e.g., fevers, joint/muscle pain, conjunctivitis) may assuage discomforts, but does not rid the body of the virus nor make one less infectious. Current efforts focused on development of a vaccine are still months from fruition, and thus of little consequence to tens of millions currently at risk of infection. Since ZIKV is clinically benign for most patients, any future vaccine’s side-effects must be extremely minimal for it to offer reasonable risk-benefits.

The unknowns of ZIKV transmission, treatment and prevention lend to multiple, challenging questions on the medical and public health impacts including:

—How many resources should be expended to test asymptomatic travelers and those living in endemic areas when current data are insufficient to accurately assess risk to a pregnancy from the disease?

—Even if a safe vaccine can be developed, initial supplies will be limited. Who gets available vaccines first? At-risk women of child-bearing years may be at the front of the line now, but might this change as epidemiologic findings on GBS or other conditions materialize?

—Are suggested restrictions on pregnancy in El Salvador, Colombia, Ecuador and Jamaica warranted given their significant impacts on reproductive rights, economic interests and social status?

—Should females of child-bearing age (or their partners) avoid travelling to endemic countries given the risks, or should travel recommendations be dispensed altogether in lieu of prudent use of contraception and/or screening for pregnancy?

—Are enhanced domestic public health responses, including aggressive mosquito control efforts, warranted despite potential risks from public exposure to vector control agents?

Legal Triage In Response to ZIKV
Just as medical and public health practitioners are working to address key determinants regarding testing, screening, treatment, vaccination and prevention of ZIKV, law and policy-makers are assessing emerging legal issues. Legal triage entails prioritization of these issues in real-time to facilitate legitimate public health and medical responses by: (1) identifying enabling and disabling issues; (2) gauging changing legal and ethical norms; (3) crafting and explaining innovative solutions; and (4) consistently revisiting the utility and efficacy of legal guidance. Initial answers via legal triage can change immediately via declared states of emergency, disaster, or public health emergency, as in Florida, Puerto Rico and Hawaii. With conditions like ZIKV, where medical and public health findings are constantly evolving, the practice of medical and legal triage intersect, as illustrated below.

Testing and Screening. Public health legal powers to test and screen individuals and populations vary. They include purely voluntary recommendations, mandatory measures that set conditions on testing, and compulsory interventions. What is legally authorized depends on what is justified from a public health or medical perspective. For example, government recommendations for voluntary ZIKV testing of adult pregnant women are lawful even if test results are somewhat unreliable. So long as the testing is truly voluntary a patient may choose whether to participate or not via informed consent.

Still, even voluntary testing can implicate difficult policy choices. Recently, federal legislators objected to the potential for federal ZIKV preparedness funds to support women who may choose abortions if faced with positive ZIKV test results. Profound reproductive rights issues surround access and use of contraception and abortion, especially among pregnant minors. Many of the nations experiencing widespread ZIKV infections have religious foundations and related laws that deeply conflict with these services. In countries like Colombia, El Salvador and Ecuador, where government recommendations to avoid pregnancy have emerged, lawful access to safe abortions is minimal, if non-existent.

Contrast a voluntary approach to mandatory testing of infants. Mandatory newborn screening for a multiple condition is common practice in the US. Adding ZIKV to the list of newborn conditions tested may seem pragmatic, but could still lead to legal questions. Until ZIKV threatens a greater portion of pregnant women domestically, screening recommendations may apply only to at-risk groups like infants born to mothers with prior or current exposures to endemic regions. Potential for discrimination arises as mothers (e.g., migrants from Mexico) are targeted for screening. Furthermore, mandatorily screening infants for ZIKV at birth may be questionable if there are no proven interventions to address their potential medical complications. Conversely, if efficacious treatments for ZIKV infections among infants become a part of the standard of care, failures to screen at risk infants may lead to liability later if their disabilities could have been prevented.

Allocation of Vaccines/Treatment. One of the most difficult issues in the context of emerging infectious disease outbreak is how to allocate available limited resources, particularly medical countermeasures. The Institute of Medicine noted in its 2012 Crisis Standards of Care report that the actual “crisis” in disease outbreaks is often the lack of essential resources and not the condition itself. How limited resources are distributed is ethically perplexing, especially given intersecting shifts in medical data and legal responsibilities.
As noted above, if a safe, efficacious ZIKV vaccine was available now, females of child-bearing years at risk of exposure may be first in line for access. This sort of allocation seems legally non-controversial. That is, until suggestions about the potential adverse effects of the vaccine arise, whether based in fact or fiction. Pervasive mistruths about current childhood vaccine safety continue to hamper vaccination rates in specific subpopulations in the US. In 2015, California legislated away existing vaccine exceptions for religious and philosophical exemptions. The mere specter of adverse events related to ZIKV vaccines may obviate their use, changing the nature of how they are allocated.

Travel Limitations. The 2016 Summer Olympics in Brazil and continued mosquito migrations to North America heighten the potential for rapid global spread of ZIKV. While infections directly through mosquitos are by far the surest path to contracting ZIKV, other transmission routes (discussed above) may lend to international or national travel restrictions of questionable legality.

Concerned about discrimination and trade, WHO has expressed disdain for any national travel bans or restrictions. CDC has issued voluntary travel warnings for pregnant women and others in affected countries. As seen in response to EVD and SARS, other nations may impose restrictive travel policies on their citizens or attempt to keep out or screen persons arriving from “hot zones.” To be lawful, travel-based limits or screening protocols must be efficacious based on known risks of transmission of ZIKV. So long as the spread of ZIKV continues to be dominated by mosquitos, and not people, travel restrictions or bans lack utility, carry significant economic impacts and potentially infringe human rights.

Mosquito Abatement. Controlling mosquitos to prevent disease is a consummate goal of public health authorities. The rapid spread of West Nile virus [PDF] domestically in the early 2000s prompted state and local governments to implement or enhance mosquito abatement programs, often through mosquito control districts. Yet, transmission of ZIKV via the “cockroach of mosquitoes” presents unique challenges. Finding and killing Aedes mosquitoes are not easy. They can breed in small amounts of water (think bottle caps and birdbaths, not ponds) and tend to fly no more than 100 meters from their source. Typical fumigation of communities may not fully address their spread.

As a result, community education on mosquito source reduction is integral. Hawaii launched its “Fight the Bite [PDF]” campaign in January 2016 to provide information and resources for eliminating breeding grounds from homes and properties. CDC recommends source reduction and larvicide treatments early in the breeding season, and adulticide treatments only after local ZIKV cases are detected. Widespread pesticide application, however, may invoke public and private opposition given potential harms to the environment (e.g., plants, animals, water supply), private property (e.g., vehicular paint damage) and the public’s health. Compliance with legal pesticide requirements, use of integrated pest management and proper training of pesticide applicators can minimize risks and liabilities. State and federal water laws may require spray permits or environmental impact assessments, subject to waiver under appropriate emergency declarations. Use of genetically modified mosquitos and mosquito-killing bacteria, currently under consideration internationally, may raise public concerns and implicate new legal requirements in the US.

Not everyone may be able or willing to assist in mosquito abatement efforts. In such cases, laws in many jurisdictions allow public health officials to classify private property as a public health nuisance to require mosquito abatement actions by owners. Still, owners may object through right-of-entry claims or simply fail to comply with public health orders, hindering abatement efforts.

Zika may not generate the same fears as Ebola, but it does present other, complex social challenges. Some issues will be clarified as public health authorities and medical providers learn more. As new data arise, key decisions in medical and legal triage for the management of this emerging infectious threat must be made in unison based on best medical and legal practices leading to improved health outcomes.

James G. Hodge, Jr., JD, LLM, is a Professor of Public Health Law and Ethics, and Director, Public Health Law and Policy Program at Sandra Day O’Connor College of Law, Arizona State University (ASU). John L. Hick, MD, is a Professor of Emergency Medicine at the University of Minnesota School of Medicine and an Emergency Physician at Hennepin County Medical Center. Dan Hanfling, MD, is a Contributing Scholar at the UPMC Center for Health Security and Clinical Professor of Emergency Medicine, George Washington University School of Medicine. Sarah Wetter, JD candidate (2017), is a Senior Legal Researcher, Public Health Law and Policy Program at Sandra Day O’Connor College of Law, ASU.

Suggested citation: James G. Hodge et al. Zika Virus and the Intersection of Medical and Legal Triage, JURIST – Academic/Commentary, Feb. 18, 2016, http://jurist.org/forum/2016/02/james-hodge-zika-virus.php.