By Cullen Archer for the Center for Law and Biomedical Sciences Blog.
The Disease
Ebola hemorrhagic fever is a zoonosis[1] caused by a virus of the family Filoviridae, whose members comprise two genera of enveloped, negative, single-stranded RNA viruses: Marburgvirus and Ebolavirus.[2] Initial clinical symptoms of sudden onset fever, chills, myalgia, and malaise are followed by flu-like symptoms (nasal discharge, cough, and shortness of breath), gastrointestinal symptoms (diarrhea, nausea, vomiting, and abdominal pain) and finally, hemorrhagic symptoms in the most severe cases.[3] Treatment of patients is primarily supportive and has not changed appreciably since the 1950s: no antiviral drug has proven effective in nonhuman primates when symptoms have already appeared and no licensed vaccine is currently available.[4] Because infection occurs through contact with infected body fluids or through parenteral injection, most cases occur in persons providing direct care to patients, such as family members or health care professionals (HCPs).[5] Factors that increase the risk for exposure while caring for patients with Ebola virus disease (EVD) include the low infectious dose of Ebola (1 to 10 virion particles) sufficient to cause infection, the high quantity of virus shed in the large volume of body fluids produced during illness, the close and extended patient contact time required of providers, the need for invasive procedures, and the absence of proven effective therapeutics.[6] Interestingly, recent data from Liberia and Sierra Leone have begun to demonstrate clusters of Ebola cases among HCPs working in facilities that are not Ebola treatment units.[7] CDC guidelines currently stratify exposure into different risk categories: “High Risk” exposure includes percutaneous or mucous membrane exposure with a symptomatic Ebola-infected person; “Some Risk” exposure includes direct contact while using appropriate Personal Protective Equipment (PPE) with a symptomatic Ebola-infected person in countries with widespread Ebola virus transmission; “Low Risk” exposure includes having been in a country with widespread Ebola virus transmission within the past 21 days and having had no known exposures.[8]
An epidemiological study of the 2014 West African epidemic calculated a total case fatality rate of 70.8% (95% confidence interval, CI, 68.6 to 72.8), consistent among Guinea, Liberia, and Sierra Leone.[9] The data also revealed a mean incubation period of 11.4 days with approximately 95% of case patients having symptom onset within 21 days after exposure, which is the recommended period for follow-up of contacts.[10] The virus is generally detectable by real-time reverse transcriptase polymerase chain reaction (RT-PCR) from 3-10 days after symptoms appear.[11] Concentrations of IgM and IgG antibodies start to rise between 10 and 18 days and between 17 and 25 days, respectively, after the infectious contact.[12] The appearance of antibodies occurred somewhat later in asymptomatic patients than in symptomatic patients who recovered (day 3 following disease onset, about 8–11 days after presumed exposure assuming a 5–8 day incubation period).[13] Despite seroconversion, circulating Ebola antigen was never detected in asymptomatic individuals.[14]
The Issue
On October 24, 2014, Kaci Hickox, R.N., arrived in Newark, New Jersey after an international flight from Sierra Leone.[15] Ms. Hickox arrived just hours after New Jersey Gov. Chris Christie’s and New York Gov. Andrew Cuomo’s announcement about the mandatory quarantine.[16] The governors announced the quarantine rule one day after New York City doctor Craig Spencer, who had recently returned from treating Ebola patients in Guinea, tested positive for Ebola.[17] Ms. Hickox had been on a one-month Doctors Without Borders assignment caring for patients infected with Ebola.[18] A scanner recorded her temperature at 101°F, although Hickox explained that the temperature reading was incorrect and requested healthcare personnel to repeat her temperature again.[19] Officials referred Ms. Hickox to University Hospital in Newark, where upon arrival, she was isolated in a quarantine tent.[20] A blood test for Ebola virus returned negative.[21] Officials held her under institutional quarantine until her release to home quarantine, in Maine, on October 27, 2014.[22] When Hickox arrived in Maine, the state’s governor ordered her to abide by that state’s policy that HCPs who arrive from West Africa remain under a 21-day home quarantine, with their condition actively monitored.[23] Maine Governor Paul LePage explained, “While we certainly respect the rights of one individual, we must be vigilant in protecting 1.3 million Mainers, as well as anyone who visits our great state.”[24] The Maine Center for Disease Control and Prevention (CDC) released its own guidelines providing that anyone who came into direct contact with “Ebola-positive individuals” would require active monitoring and be quarantined in their home.[25] California announced a mandatory 21-day quarantine for any travelers who had contact with an Ebola patient, whether or not the travelers showed symptoms.[26] Gov. Rick Perry of Texas cited CDC guidelines in announcing that another nurse returning from Sierra Leone who showed no signs of the disease had agreed to a “self-quarantine” at home, which would include twice-daily monitoring by the state Department of Health.[27] When Ms. Hickox fought her quarantine, Maine District Court Chief Judge Charles LaVerdiere ruled in favor of Ms. Hickox because local health officials failed to prove the need for a stricter order enforcing an Ebola quarantine, he ordered her to submit to “direct active monitoring,” coordinate travel with public health officials, and immediately notify health authorities should symptoms appear.[28] She completed her 21-day monitoring period, Ebola-free, on November 10, 2014.[29]
Current Quarantine Practice
The concept of quarantine of HCPs is not a new one. Medical professionals already self-quarantine, to a degree, in the context of occupational exposure to HIV. Even before the use of Highly Active Anti-Retroviral therapy, the pooled risk for HIV-1 infection after a single percutaneous exposure was 0.29% per exposure (CI, 0.13% to 0.70%).[30] Despite this low risk, the CDC recommends that HCPs exposed to HIV should be evaluated within hours (rather than days) after their exposure and should be tested for HIV at baseline.[31] When the guidelines recommend post-exposure prophylaxis, the HCP should self-administer oral anti-retroviral therapy for 28 days.[32] During this time, the exposed HCP should use precautions (e.g. use of barrier contraception and avoidance of blood or tissue donations, pregnancy, and, if possible, breast-feeding) to prevent secondary transmission, especially during the first 6–12 weeks after exposure.[33] Notably, the case fatality rate for HIV comes nowhere near the case fatality rate for EVD. Even with a seroconversion rate of less than 0.3%, HCPs generally self-quarantine by using a barrier method or abstinence to prevent secondary infection of their partners. In other words, HCPs do a lot more for a lot less.
Legal Authority
Federal statute provides for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease[34] and (A) moving or about to move interstate; or (B) to be a probable source of infection to individuals who, while infected with such disease, will be moving interstate.[35] Such regulations may provide that if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary.[36]
In Jacobson v. Massachusetts, 197 U.S. 11 (1905), the Supreme Court considered the constitutionality of a state statute authorizing local boards of health to require and enforce vaccination. The statute provided that if the board of health of a city or town determined vaccination was necessary for public health or safety, the board shall require and enforce the vaccination and revaccination of all the inhabitants, and shall provide them with the means of free vaccination.[37] Jacobson refused to comply with a Cambridge board of health regulation requiring all city inhabitants, who had not been successfully vaccinated against smallpox since March 1st, 1897, be vaccinated or revaccinated.[38] Jacobson argued that the statute derogated rights secured by the 14th Amendment.[39] The Court explained that the authority of the state to enact this statute is derived from its police power and recognized “the authority of a state to enact quarantine laws and health laws of every description.”[40]
[T]he rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand. An American citizen arriving at an American port on a vessel in which, during the voyage, there had been cases of yellow fever or Asiatic cholera, he, although apparently free from disease himself, may yet, in some circumstances, be held in quarantine against his will on board of such vessel or in a quarantine station, until it be ascertained by inspection, conducted with due diligence, that the danger of the spread of the disease among the community at large has disappeared. . . .[41] [T]he legislature has the right to pass laws which, according to the common belief of the people, are adapted to prevent the spread of contagious diseases.[42]
Finding the statute constitutional, the Court held that no one could confidently assert that the means prescribed by the state to stamp out smallpox had no real or substantial relation to the protection of the public health and the public safety.[43] In Workman v. Mingo Cnty. Bd. of Educ., 419 F. App’x 348 (4th Cir. 2011), the parties disagreed about the level of scrutiny that should apply to laws requiring vaccination that substantially burden the free exercise of religion.[44] While Workman argued that strict scrutiny applied, Defendants argued that the Supreme Court in Employment Div., Dep’t of Human Res. of Or. v. Smith, 494 U.S. 872 (1990), abandoned the compelling interest test, and that the statute should be upheld under rational basis review.[45] Declining to decide this issue, the circuit court explained that prior Supreme Court decisions guided its conclusion that West Virginia’s vaccination laws withstood even strict scrutiny.[46] In U.S. ex rel. Siegel v. Shinnick, 219 F. Supp. 789 (E.D.N.Y. 1963), relator returned from a trip to Stockholm, a smallpox infected local area, but did not present a valid certificate of vaccination against smallpox.[47] Her daughter filed a habeas petition for her release because relator was held in isolation at the U.S. Public Health Hospital for the balance of the 14-day smallpox incubation period.[48] The court deferred to the medical judgment of three expert witnesses whose conclusion could not be challenged on the ground that they had no evidence of the exposure of Relator to smallpox: (1) they were not free to ignore the facts that opportunity for exposure existed during her four days in Stockholm; (2) no one could know for fourteen days whether or not there had been exposure, and (3) Relator’s history of unsuccessful vaccinations put her in a position to have become infected and to infect others.[49]
Legal authority supports the apprehension, examination, and quarantine of Ebola-exposed individuals returning from an infected locality. Where Ebola has been specified under Executive Order 13295 as a quarantinable communicable disease, 42 U.S.C. § 264 (2012) authorizes the apprehension and examination of any individual, traveling between states and reasonably believed to be infected. States have authority under their police powers to authorize the quarantine of an Ebola-exposed individual. Because direct contact with a symptomatic Ebola-infected persons, even while using appropriate PPE, in countries with widespread Ebola virus transmission poses “Some Risk” of Ebola infection according to CDC guidelines, the government could reasonably require examination and quarantine of a returning HCP. Recent data from Liberia and Sierra Leone suggest that examination and quarantine of HCPs with no known Ebola exposure, but providing medical care in an Ebola-infected local area, might be justified. As to whether these statutes must pass rational basis review or strict scrutiny, it is likely that statutes requiring quarantine of exposed individuals for 21 days—the incubation period at the 95% confidence interval—would pass either standard of review. The government could easily argue that its statute is rationally related to the legitimate government interest in preventing the spread of a disease with a 70% case fatality rate. Likewise, the government could also argue that a statute designed to prevent the spread of Ebola, limiting quarantine to 21 days for exposed individuals and monitoring every 12 hours, is narrowly tailored to achieve a compelling government interest.
Conclusion
Even though legal authority supports the apprehension, examination, and quarantine of a healthcare professional reasonably believed to be infected with Ebolavirus, one could reasonably expect healthcare professionals to hold themselves to a higher standard for the protection of their patients and the general public. If a medical professional wouldn’t expose their partner to secondary infection from HIV, why would that medical professional shirk their responsibility to public health with the cavalier attitude of resisting quarantine? A reasonable HCP would regard Ebola, which has a higher virulence and higher mortality rate, at least as seriously as HIV.
Ms. Hickox stated that she “understands how fear spreads” and asserts that stigmatization of health workers has “exploded” across the country.[50] She then warns that quarantines would ultimately lead to families being shuttered inside their homes and deter aid workers from going to West Africa to treat Ebola at its origin.[51] In citing fear, Ms. Hickox has failed to understand that the current Ebola quarantine regimen is based on medical evidence. New data will require modifications. As any medical professional should know, providing quality care to patients often involves a careful explanation of the advantages and disadvantages of various therapeutic options. A U.S. healthcare professional considering whether to provide voluntary medical care in a foreign Ebola-infected locality should make a similar assessment: (1) If I choose to travel to an Ebola-infected local area, I might die for various reasons; but if I do not die, I will need to quarantine myself for 21 days upon return; or (2) I can choose not to go. As for myself, I would voluntarily self-quarantine. My family would understand.
Cullen Archer is currently a third year law student at the University of Utah S. J. Quinney College of Law. Cullen graduated from the University of Texas in Austin with a B.A. in Chemistry and the University of Texas Health Science Center at San Antonio with a Doctor of Medicine. Cullen has returned to law school after practicing Obstetrics & Gynecology for many years and is focusing his studies on healthcare law and intellectual property. He volunteers at the Pro Bono Initiative Medical-Legal Clinic. He is also an avid golfer, scuba diver, and antiquarian book collector.
[1] Zoonoses are infectious diseases that are naturally transmitted between vertebrate animals and humans. Victor L. Yu, Zoonoses, in Mechanisms of Microbial Disease 848, 848, (Moselio Schaechter et al., eds. 2d edition, 1993).
[2] Carlos del Rio et al., Ebola Hemorrhagic Fever in 2014: The Tale of an Evolving Epidemic, Annals Internal Med. *1, *1 (August 19, 2014), http://annals.org/article.aspx?articleid=1897363&resultClick=3.
[3] Id.
[4] Id. at *2.
[5] Id. at *1.
[6] Brooke K. Decker et al., Preparing for Critical Care Services to Patients With Ebola, Annals Internal Med. *1, *1 (September 23, 2014), http://annals.org/data/Journals/AIM/0/0000605-201412160-00132.pdf.
[7] Centers for Disease Control and Prevention, Ebola Virus Disease Cases Among Health Care Workers Not Working in Ebola Treatment Units — Liberia, June–August, 2014, Morbidity and Mortality Weekly Report (November 14, 2014), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm63e1114a3.htm?s_cid=mm63e1114a3_w. See also Associated Press, Doctor with Ebola arrives in US from Sierra Leone, MSN News, November 15, 2014, http://www.msn.com/en-us/news/us/doctor-with-ebola-arrives-in-us-from-sierra-leone/ar-BBdGEI7?ocid=iehp.
[8] Centers for Disease Control and Prevention, Epidemiologic Risk Factors to Consider when Evaluating a Person for Exposure to Ebola Virus, http://www.cdc.gov/vhf/ebola/exposure/risk-factors-when-evaluating-person-for-exposure.html (last updated November 14, 2014).
[9] WHO Ebola Response Team, Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections, 371 New England J. Med. 1481, 1486 (October 16, 2014).
[10] Id. at 1487.
[11] Centers for Disease Control and Prevention, Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with Suspected Infection with Ebola Virus Disease, http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html (last updated October 22, 2014).
[12] E M Leroy et al., Human asymptomatic Ebola infection and strong inflammatory response, 355 Lancet 2210, 2212 (2000).
[13] Id.
[14] Id.
[15] Kaci Hickox, Her story: UTA grad isolated at New Jersey hospital in Ebola quarantine, Dallas News, October 25, 2014, http://www.dallasnews.com/ebola/headlines/20141025-uta-grad-isolated-at-new-jersey-hospital-as-part-of-ebola-quarantine.ece.
[16] Carly Schwartz, Nurse Under Ebola Quarantine Hires Civil Rights Lawyer, Huffington Post, October 26, 2014, http://www.huffingtonpost.com/2014/10/26/kaci-hickox-lawyer_n_6050450.html.
[17] Id.
[18] Hickox, supra note 15.
[19] Clinicians should find such denial of objective evidence disturbing. This type of denial has been seen in the treatment of obstetrical patients with pre-eclampsia, a hypertensive disease in pregnancy characterized by an increased risk for, inter alia, seizures, abruption, and stillbirth. A pregnant patient presenting with an elevated sitting manual blood pressure might be placed recumbent on her left side. As expected, the blood pressure is often then found to be lower, even normal. Sometimes this is the blood pressure that is recorded in the chart. Unfortunately, these patients still seize, abrupt, and experience fetal death. Incredibly, the medical staff involved are surprised when this occurs. See also Samuel Shem, The House of God 127 (Penguin 2010)(a satirical novel about medical training in which Law Number 10 states: “If you don’t take a temperature, you can’t find a fever.”)
[20] Hickox, supra note 15.
[21] Id.
[22] Katie Kindelan & Aaron Katersky, Nurse Kaci Hickox ‘Will Go to Court’ Over Maine Ebola Quarantine Rule, abcNews, October 29, 2014, http://abcnews.go.com/US/nurse-kaci-hickox-court-maine-ebola-quarantine-rule/story?id=26535878.
[23] Id.
[24] Kate Zernike & Emma G. Fitzsimmons, Threat of Lawsuit Could Test Maine’s Quarantine Policy, The New York Times, October 29, 2014, http://www.nytimes.com/2014/10/30/us/kaci-hickox-nurse-under-ebola-quarantine-threatens-lawsuit.html?_r=0.
[25] Josh Margolin & Meghan Keneally, Ebola Nurse Kaci Hickox Will ‘Understand’ Her Quarantine, New Jersey Governor Says, abcNews, October 27, 2014, http://abcnews.go.com/Health/ebola-nurse-kaci-hickox-understand-quarantine-jersey-governor/story?id=26479917.
[26] Kindelan, supra note 22.
[27] Id.
[28] Ray Sanchez, Catherine E. Shoichet, and Faith Karimi, Ebola update: Maine judge rejects quarantine for nurse Kaci Hickox, CNN Health, November 1, 2014, http://www.cnn.com/2014/10/31/health/us-ebola/index.html.
[29] E. Sydney Lupkin, What Kaci Hickox Will Do After 21-Day Monitoring Ends, abcNews, November 10, 2014, http://abcnews.go.com/Health/kaci-hickox-21-day-monitoring-ends/story?id=26812650.
[30] David K. Henderson et al., Risk for Occupational Transmission of Human Immunodeficiency Virus Type 1 (HIV-1) Associated with Clinical Exposures: A Prospective Evaluation, 113 Annals of Internal Med. 740, 744 (November 15, 1990).
[31] Centers for Disease Control and Prevention, Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis, Morbidity and Mortality Weekly Report (June 29, 2001), http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm.
[32] Id.
[33] David T. Kuhar et al., Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis, 34 Infection Control & Hospital Epidemiology 875, 883 (September 2013).
[34] Regulations prescribed under 42 U.S.C. § 264 shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President. 42 U.S.C. § 264(b) (2012)(emphasis added). Ebola was named as a specified communicable disease in Executive Order No. 13295. Revised List of Quarantinable Communicable Diseases, 68 Fed. Reg. 17255 (April 9, 2003).
[35] 42 U.S.C. § 264(d)(1) (2012).
[36] Id.
[37] Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 12 (1905).
[38] Id. at 12-13.
[39] Id. at 13.
[40] Id. at 24-25.
[41] Id. at 29.
[42] Id. at 35.
[43] Id. at 31.
[44] Workman v. Mingo Cnty. Bd. of Educ., 419 F. App’x 348, 353 (4th Cir. 2011).
[45] Id.
[46] Id. (citing Jacobson, 197 U.S. 11 (1905))
[47] U.S. ex rel. Siegel v. Shinnick, 219 F. Supp. 789, 790 (E.D.N.Y. 1963).
[48] Id.
[49] Id. at 791.
[50] Zernike, supra note 24.
[51] Zernike, supra note 24.