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COVID-19: THE ETHICAL AND LEGAL IMPLICATIONS OF MEDICAL RATIONING
Samuel D. Hodge, Jr.,* and Jack E. Hubbard**
Life is not measured by the breaths we take but by the moments that take our breath away. —George Carlin
* Samuel D. Hodge, Jr., is a professor at Temple University where he teaches law, anatomy, and forensics. He is also a member of the Dispute Resolution Institute where he serves as a mediator and neutral arbitrator. He has authored more than 180 articles in medical or legal journals and has written ten books. He also enjoys an AV preeminent rating and has been named a top lawyer in Pennsylvania on multiple occasions. ** Jack, E. Hubbard, Ph.D., M.D., is a former adjunct professor of neurology at the University of Minnesota School of Medicine and is board certified in both neurology and pain medicine. In addition to his medical training, he holds a doctorate in anatomy. Dr. Hubbard has published widely on many topics in both medical and legal publications.
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TABLE OF CONTENTS
INTRODUCTION ...... 161
I. MEDICAL DISCUSSION ...... 163 A. What Is a Virus? ...... 163 B. Immune Defense System ...... 165 C. What Is a Coronavirus? ...... 166 D. What Is SARS-CoV-2?...... 168 E. What Are the Symptoms of COVID-19? ...... 170 F. Why Is COVID-19 Fatal? ...... 171 G. Mechanical Ventilation ...... 172 H. What Is the Treatment for COVID-19? ...... 174
II. ETHICAL DISCUSSION ...... 178 A. Ventilator Shortage ...... 178 B. Allocating Resources ...... 182 C. Other Ethical Considerations ...... 183
III. LEGAL DISCUSSION ...... 184 A. State Responses ...... 184 B. Federal Laws ...... 190 C. Legal Issues...... 192 1. Altered Standard of Care ...... 192 2. Duty of Care Laws in an Emergency ...... 194 3. Ventilator Safety ...... 195 4. Court Cases Dealing with Ventilators ...... 196 5. Court Cases Dealing with COVID-19 ...... 199
IV. CONCLUSION ...... 204
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INTRODUCTION
Wet markets, Wuhan, coronavirus, zoonotic disease, social distancing, and COVID-19 are terms that had little significance to most people until Wei Guixian, a worker at the Huanan Seafood Wholesale Market, contracted a deadly bug.1 On December 10, 2019, this 57-year-old woman, who initially thought that she had a cold, was hospitalized because her symptoms became progressively worse requiring medical care. An infection developed in both her lungs and she was given anti-flu medications which were ineffective.2 Other people soon started arriving at the hospital with similar symptoms, and it was discovered that they had all recently visited the outdoor market.3 At the end of the month, China informed the World Health Organization (WHO) that Ms. Guixian and several others had tested positive for COVID-19, and the course of history was forever changed.4 The illness soon became a pandemic, and it has been discovered on every continent except Antarctica.5 In the United States, the Centers for Disease Control and Prevention (CDC) has even predicted that between 2.4 million to 21 million Americans will need hospitalization for the virus and that up to 25% of these patients will need lifesaving ventilation.6 With the continued surging of COVID-19 in the United States, these projections may be modest. The coronavirus pandemic has shaken the foundation of societies around the world. From European countries to the United States, the news is replete with stories of social distancing, hardship, and death. Health officials are discussing
1. See Amanda Woods, Shrimp Vendor at Wuhan Market May Be Coronavirus ‘Patient Zero,’ N.Y. POST (Mar. 27, 2020), https://nypost.com/2020/03/27/shrimp-vendor-at- wuhan-market-may-be-coronavirus-patient-zero/. 2. Bethany Allen-Ebrahimian, Timeline: The Early Days of China’s Coronavirus Outbreak and Cover-Up, AXIOS (Mar. 18, 2020), https://www.axios.com/timeline-the -early-days-of-chinas-coronavirus-outbreak-and-cover-up-ee65211a-afb6-4641-97b8- 353718a5faab.html. 3. Woods, supra note 1. The exact origins of the virus remain unknown. Some believe that the market was not the only source of the outbreak since some people infected had not visited the market. Maria Cohut, Novel Coronavirus: Your Questions, Answered, MED. NEWS TODAY, https://www.medicalnewstoday.com/articles/novel-coronavirus-your -questions-answered (last updated Oct. 30, 2020). 4. Allen-Ebrahimian, supra note 2. The first patient who tested positive for the coronavirus in the United States was confirmed by the Offices of Disease Control and Prevention on January 21, 2020. Id. 5. Tim Newman, Coronavirus Myths Explored, MED. NEWS TODAY, https://www.medicalnewstoday.com/articles/coronavirus-myths-explored (last updated Nov. 8, 2020). 6. Robert D. Truog et. al., The Toughest Triage — Allocating Ventilators in a Pandemic, 382 NEW ENGLAND J. MED. 1973, 1973–74 (2020).
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162 GONZAGA LAW REVIEW Vol. 56:1 the potential death toll from the virus at a scale that once seemed unfathomable.7 Millions of people are unable to work at a rate that may exceed the Great Depression, and isolation protocols have forced the shuttering of innumerable businesses,8 stalling the economy and creating a global recession.9 Another round of infections is an ever-present reality, and countries that took immediate prophylactic measures to curtail the spread of the disease are still at risk each time they try to restart their economies. In this regard, there has been a reappearance of the virus in many countries, and only time will disclose if “early and aggressive” interventions were successful.10 A political divide has emerged in the United States between Republicans and Democrats over the severity of COVID-19 and whether to wear a mask despite advice from most experts that wearing a mask is one of the most effective ways to slow down the transmission of the virus.11 This article explores the medical and legal implications of the coronavirus. The medical section discusses the basics of viruses including immunity and then more specifically the coronavirus and SARS-CoV-2, which causes COVID-19. It also explains the symptoms of COVID-19 and why it is such a fatal disease. Finally, the medical section discusses management of COVID-19, focusing on the critical use of ventilators which are in such short supply. The medical section is followed by a discussion of the legal and ethical implications of a national health emergency with attention devoted to the laws that apply as well as the altered standard of care for medical professionals. The article also addresses the implications involving the rationing of ventilators and the litigation that has arisen over the years involving these life-saving devices.
7. Philip Ewing, ‘Challenging Times Are Ahead,’ Trump Says of Extended Social Distancing Guidelines, NPR (Mar. 30, 2020), https://www.npr.org/2020/03/30/821978180 /watch-coronavirus-task-force-holds-briefing-after-extending-distancing-guideline. 8. Id. 9. Philipp Carlsson-Szlezak et. al., Understanding the Economic Shock of Coronavirus, HARV. BUS. REV. (Mar. 27, 2020), https://hbr.org/2020/03/understanding-the-economic-shock- of-coronavirus. 10. Id. 11. Bryan Walsh, The U.S. Divide on Coronavirus Masks, AXIOS (June 24, 2020), https://www.axios.com/political-divide-coronavirus-masks-1053d5bd-deb3-4cf4-9570- 0ba492134f3e.html
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 163
I. MEDICAL DISCUSSION
A. What Is a Virus?
A virus is a genetically transmittable agent contained in an organic particle that can only duplicate within a host organism.12 Viruses assist in building their host species’ genomes, and therefore have played an important, dynamic role in the evolution of all life.13 As early as the 1890s, viruses were suspected to cause disease,14 but because of their extremely small size, they could not be detected with the light microscope. For example, the poliovirus is 30 nanometers (a nanometer is one billionth of a meter) across, roughly 10,000 times smaller than a grain of salt.15 Viruses are responsible for a wide range of diseases in humans, ranging from those that are relatively benign—common cold, chickenpox, and cold sores—to more serious and fatal diseases—Ebola, AIDS (HIV), and rabies.16 The particularly deadly 1918 influenza pandemic that lasted until 1920 is estimated to have killed about 50 million people worldwide.17 The reason for such a wide variety of illnesses is that most viruses have a pre-determined “affinity for specific tissue” types, termed tissue tropism.18 For example, poliovirus selectively attacks nerve cells, rhinoviruses infect cells in the upper respiratory tract, and enteroviruses have an affinity for tissues in the intestinal lining.19 While viruses can be “killed,” many researchers consider them to be at “the boundar[y] of what is considered to be life.”20 Viruses are not cells; they are
12. Virus, SCITABLE BY NATURE EDUC., https://www.nature.com/scitable/definition /virus-308/ (last visited on Nov. 8, 2020). 13. Karin Moelling, Are Viruses Our Oldest Ancestors?, 13 EMBO REP. 1033, 1033 (2012), https://www.embopress.org/doi/epdf/10.1038/embor.2012.173. 14. See E. Thomas Ewing, La Grippe or Russian Influenza: Mortality Statistics During the 1890 Epidemic in Indiana 13 INFLUENZA & OTHER RESPIRATORY VIRUSES 279, 279–82 (2018), https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.12632. 15. Aparna Vidyasagar, What Are Viruses?, LIVE SCI. (Jan. 6, 2016), https://www.livescience.com/53272-what-is-a-virus.html. 16. Peter Costa, What to Know About Viruses, MED. NEWS TODAY (May 30, 2017), https://www.medicalnewstoday.com/articles/158179. 17. Niall P.S.A. Johnson & Juergen Mueller, Updating the Accounts: Global Mortality of the 1918-1920 “Spanish” Influenza Pandemic, 76 BULL. HIST. MED. 105, 115 (2002). 18. Samuel Baron et. al., Viral Pathogenesis, in MEDICAL MICROBIOLOGY ch. 45 (Thomas Albrecht et. al. eds., 4th ed. 1996) (ebook), https://www.ncbi.nlm.nih.gov /books/NBK8149/. 19. Id. 20. Vidyasagar, supra note 15.
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164 GONZAGA LAW REVIEW Vol. 56:1 classified as intracellular parasites.21 Despite the damage that it is capable of inflicting, a virus has a quite simple structure. At the core of a virus is genetic material made of long strands of either RNA (ribonucleic acid) or DNA (deoxyribonucleic acid). This nucleic acid core, called the genome, is surrounded by a protein coat, termed a capsid, and often an outer lipid envelope, both of which protect the genetic material.22 A fully assembled virus particle with its nucleic acid core and protective protein/lipid coat is termed a virion.23 The goal of a virus is to cause the host cell to reproduce it, for a virus cannot grow or reproduce outside of a living cell.24 Unlike a living cell, a virus does not contain the required cellular machinery to maintain life and reproduce. Instead, a virus “hijacks” a host living cell and forces the cell to replicate copies of the virus, usually killing the original cell.25 Some of these copies may be made with errors, termed mutations. Because of this ability to mutate, vaccines developed for the original viral form may be ineffective against the mutated copy.26 A virus must gain access to the host’s body from the external environment—from the air via the respiratory system, through the skin by a cut or insect bite, or from oral intake into the digestive system. When it reaches its optimal cell type in the body, the virus attaches to specific receptors on the cell surface and is brought into the cell either by transferring through the cell wall or being engulfed by the cell.27 Like a Trojan horse, once inside the cell, the virus causes its damage. The nucleic acid core separates from the outer coat. The released viral genetic material (either RNA or DNA) then takes over and commands the host cell to make thousands to millions of copies of the virus.28 An RNA virus is one that contains RNA, instead of DNA, as its genetic foundation. Approximately 70% of viruses have an RNA genome.29 A number of human pathogens are RNA viruses, such as SARS virus, West Nile virus, and HIV.30 Coronaviruses are “single-stranded, positive-sense RNA viruses and have the
21. See Hans R. Gelderblom, Structure and Classification of Viruses, in MEDICAL MICROBIOLOGY ch. 41, supra note 18, https://www.ncbi.nlm.nih.gov/books/NBK8174/. 22. See id. 23. Id. 24. See Vidyasagar, supra note 15. 25. Id. 26. William C. Schiel, Medical Definition of Virus, MED. NET, https://www .medicinenet.com/script/main/art.asp?articlekey=5997 (last visited Oct. 12, 2020). 27. Vidyasagar, supra note 15. 28. Id. 29. Gelderblom, supra note 21. 30. Rutgers Univ., How RNA Viruses Copy Themselves: Hijack Cellular Enzyme to Create Viral Replication Factories on Cell Membranes, SCIENCEDAILY (May 30, 2010), https://www.sciencedaily.com/releases/2010/05/100528210736.htm.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 165 largest genomes known among RNA viruses.”31 An RNA virus replicates itself by appropriating an enzyme from the host cell to make duplication factories enhanced in a certain lipid which RNA viruses are unable to amalgamate their viral RNA and duplicate.32 Lipids are the crucial structural element on cell membranes, and frequently act as “signaling molecules” and landing locations for proteins.33 An RNA virus replicates itself in the cell cytoplasm; a DNA virus goes to the nucleus of the cell. Often this genetic commandeering leads to death (apoptosis) of the host cell by not allowing the cell to manufacture vital proteins and depleting the resources that it needs to survive.34 With cell death, the viral particles are released to infect other cells. Paradoxically, the host cell also can be destroyed by the body’s immune mechanisms that fight off the virus with the excessive release storm of agents such as antibodies, cytokines, and cytotoxic T cells.35
B. Immune Defense System
To fight viruses, the body has a complex immune defense system consisting of two major components: antibodies (humoral immunity) and killer white blood cells (cell-mediated immunity).36 These defenses are initiated upon exposure to the virus and ramp-up within three to ten days after exposure.37 Concerning humoral immunity, upon detecting the virus, specialized white blood cells called B lymphocytes are stimulated to produce antibodies that are specific for the antigens found on that virus. The antibodies, specifically IgG, IgM, and IgA, can neutralize the virus by blocking the attachment of the virus to the cell, preventing transference of the virus into the cell, or preventing removal of the virus’s protective protein coat.38 Also, antibodies can tag the virus before it enters the cell so that the killer white cells can identify and destroy the virus.39 A remarkable characteristic of the immune system is that it learns the infections
31. Fernando Almazan et al., Engineering the Largest RNA Virus Genome as an Infectious Bacterial Artificial Chromosome, 97 PROC. OF THE NAT’L ACAD. OF SCIS. 5516, 5516 (2000). 32. Rutgers Univ., supra note 30. 33. Id. 34. Id. 35. Gary R. Kimpel, Immune Defenses, in MEDICAL MICROBIOLOGY, supra note 18, https://www.ncbi.nlm.nih.gov/books/NBK8423/. 36. Id. 37. Id. 38. Id. 39. Id.
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166 GONZAGA LAW REVIEW Vol. 56:1 it has confronted in the past thereby making it simpler to attack the identical virus or bacteria in the future.40 With cell-mediated immunity, specialized white blood cells (leucocytes) actively hunt out and destroy the virus. Identified as cytotoxic T cells, natural killer (NK) cells, and macrophages, these leucocytes also produce cytokines, small proteins that further direct the immune response against viruses.41 However, a cytokine reaction can be excessive, releasing too many of the substances into the blood, termed a cytokine storm.42 A cytokine storm can lead to high fever, pronounced tissue inflammation with swelling and may be life- threatening or lead to organ failure.43 This overreaction of the immune system contributes to the fatalities caused by the pandemic-causing coronavirus.44
C. What Is a Coronavirus?
The coronavirus causes a respiratory illness and can be transmitted from individual to individual.45 It is an RNA virus that is spherical in shape, measuring about 125 nanometers across.46 The coronavirus name derives from multiple club-shaped protein structures that extend like spikes from the capsid covering, giving the virus a crown-like appearance when viewed with the electron microscope.47 The coronavirus RNA genome is 30,000 bases, making it the
40. Viral Attack, Memory Cells, ARIZ. ST. U., https://askabiologist.asu.edu/memory -b-cell (last visited Nov. 1, 2020). 41. Kimpel, supra note 35. 42. Allison George, Cytokine Storm: An Overreaction of the Body’s Immune System, NEW SCIENTIST https://www.newscientist.com/term/cytokine-storm/ (last visited Nov. 1, 2020). 43. Id.; Korin Miller, How Covid-19 Sets Off a Deadly “Cytokine Storm” in Some Patients, According to Doctors, PREVENTION (June 22, 2020), https://www.prevention.com /health/a32906012/cytokine-storm-coronavirus/. 44. George, supra note 42. 45. What You Should Know About COVID-19 to Protect Yourself and Others, CDC, https://www.cdc.gov/coronavirus/2019-ncov/downloads/2019-ncov-factsheet.pdf (last visited Nov. 11, 2020). 46. Anthony R. Fehr & Stanley Perlman, Coronaviruses: An Overview of Their Replication and Pathogenesis, in 1282 METHODS IN MOLECULAR BIOLOGY 1, 2 (Helena Jane Maier et. al. eds. 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4369385/pdf/978-1 -4939-2438-7_Chapter_1.pdf. 47. See David A.J. Tyrrell & Steven H. Myint, Coronaviruses, in MEDICAL MICROBIOLOGY ch. 60, supra note 18, https://www.ncbi.nlm.nih.gov/books/NBK7782/.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 167 longest of any RNA virus.48 This RNA length coupled with the lack of an “error- correction mechanism[]” increases the opportunity for viral copy mistakes, leading to the rapid production of mutations.49 This fact means that the mutations may have new properties such as the ability to infect new cell types.50 Because the virus can mutate, the coronavirus can evade immune systems and even jump from species to species.51 The coronavirus is transmitted by airborne droplets; a single sneeze can distribute as many as 20,000 virus-laden droplets into the environment.52 It may also be spread “by touching a surface or object that has the virus on it and then touching [the] mouth, nose, or eyes.”53 It is not believed that such contact is the main way the virus is transmitted, but scientists are still discovering more about this illness.54 Once the virus enters the nasal passages, it targets the epithelial cells lining the respiratory system.55 When a coronavirus reaches an epithelial cell, the protein spikes attach to specific receptors on the cell. The viral outer coat then fuses with the cell wall and the RNA contents are pulled into the cell’s cytoplasm. The viral RNA takes over the cell’s protein manufacturing machinery, instructing it to read the RNA and make new copies of the virus. The infected epithelial cell can produce and release millions of copies of the virus before it finally becomes depleted and dies.56 The respiratory diseases caused by coronavirus vary depending upon their type. Many of the coronaviruses (229E, NL63, OC43, HKU1) produce mild, self- limiting respiratory infections with cold-like symptoms.57 These coronavirus
48. Simon Makin, How Coronaviruses Cause Infection — From Colds to Deadly Pneumonia, SCI. AM. (Feb. 5, 2020), https://www.scientificamerican.com/article/how -coronaviruses-cause-infection-from-colds-to-deadly-pneumonia1/. 49. Id. 50. Id. 51. Id. 52. Vidyasagar, supra note 15. 53. Coronavirus Disease 2019 (COVID-19), How Covid Spreads, CDC, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (last updated Oct. 4, 2020). 54. See id. It is believed that the virus can be found in an aerosol for at least 3 hours, 72 hours on plastic, 48 hours on stainless steel, 24 hours on cardboard and 4 hours on copper. Mark Graber, COVID-19: Updated Information About Diagnosis, Treatment, Prevention, Etc., MGRAW HILL MED. (May 28, 2020), https://www.accessmedicinenetwork.com/posts /covid-19-updated-information-about-diagnosis-treatment-prevention-etc. 55. See Fehr & Perlman, supra note 46, at 13. 56. See Jonathon Corum & Carl Zimmer, How Coronavirus Hijacks Your Cells, N.Y. TIMES (Mar. 13, 2020), https://www.nytimes.com/interactive/2020/03/11/science/how -coronavirus-hijacks-your-cells.html. 57. Fehr & Perlman, supra note 46, at 12.
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168 GONZAGA LAW REVIEW Vol. 56:1 entities are endemic within the human population and “caus[e] 15–30% of respiratory tract infections each year.”58 After a three day incubation period, the infected person experiences symptoms of a common cold—nasal congestion, runny nose, sneezing and coughing.59 After several days, the body’s immune system, primed from previous infections, can fight off the virus and the person recovers.60 This casual regard toward coronaviruses changed in 2003 when a coronavirus (SARS-CoV) caused a deadly SARS (severe acute respiratory syndrome) outbreak in China.61 The source of the virus was traced to exotic animals, including the Himalayan civet cat and raccoon dogs, which spread the infection to humans.62 Similarly, a coronavirus (MERS-CoV) from a camel caused a MERS (Middle East Respiratory Syndrome) outbreak in Saudi Arabia that has killed about 881 people since 2012.63 The ability of a disease to jump from an animal to infect a human is termed zoonosis or zoonotic spread.64 These specific coronavirus diseases are more deadly because rather than targeting the upper respiratory tract—the nose and throat—they target the lower respiratory tract—the lungs—which is more likely to result in pneumonia.65
D. What Is SARS-CoV-2?
COVID-19 (COronaVIrus Disease identified in 2019), the current coronavirus infection plaguing the world, is caused by a novel virus, meaning that it has never infected humans before.66 Identified as SARS-CoV-2, this is
58. Id. 59. Tyrrell & Myint, supra note 47. 60. See id. 61. Jun Zheng, SARS-CoV-2: An Emerging Coronavirus That Causes a Global Threat, 16 INT. J. BIO. SCI. 1678 (2020); NS Zhong et. al., Epidemiology and Cause of Severe Acute Respiratory Syndrome (SARS) in Guangdong, People’s Republic of China, in February, 2003, 362 LANCET 1353, 1353 (2003). 62. See Fehr & Perlman, supra note 46, at 13. 63. Id. at 13–14; Middle East Respiratory Syndrome Coronavirus (MERS-CoV), WHO, https://applications.emro.who.int/docs/EMRPUB-CSR-241-2019-EN.pdf (last visited Nov. 11, 2020). 64. Zoonotic Diseases, CDC, https://www.cdc.gov/onehealth/basics/zoonotic -diseases.html (last visited Nov. 11, 2020). 65. Makin, supra note 48; see also Fehr & Perlman, supra note 46, at 12. 66. Coronavirus Disease 2019 (COVID-19), Frequently Asked Questions, CDC, https://www.cdc.gov/coronavirus/2019-ncov/faq.html (last updated Nov. 12, 2020).
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 169 only the seventh coronavirus to which humans are known to be susceptible,67 and appears to be highly contagious; being within six feet of an infected person for 15 minutes within any 24-hour period is considered a “high risk” exposure.68 First discovered in December 2019 in Wuhan, Hubei province, China, SARS- CoV-2 initially was thought to have been spread by zoonotic transfer from a certain species of bat, because of a 96% similarity with the coronavirus genome found in that bat, or from Malayan pangolins illegally imported to China.69 Other theories suggest that the virus came from a laboratory where researchers were trying to manipulate a similar coronavirus.70 The Communist Party media in China and certain conspiracy theorists even assert that the outbreak is the result of a U.S. biological weapon, falsely claiming that U.S. Army reservist Maatje Benassi is the source of the virus and that she spread it when she was in Wuhan for the Military World Games.71 In reality, the exact origin of the virus causing COVID-19 remains unclear.72 The coronavirus receives its name because of the “crown-like spikes that protrude from their surfaces, resembling the sun’s corona.”73 The protein spikes on the SARS-CoV-2 virus target and latch onto ACE-2 receptors found on cells lining organs such as the heart and lungs.74
67. Kristian G. Andersen et. al., The Proximal Origin of SARS-CoV, 26 NATURE MED. 450, 450 (2020), https://www.nature.com/articles/s41591-020-0820-9. 68. Coronavirus Disease 2019 (COVID-19), Public Health Guidance for Community- Related Exposure, CDC, https://www.cdc.gov/coronavirus/2019-ncov/php/public-health -recommendations.html (last updated Nov. 16, 2020). 69. Andersen, supra note 67, at 450–51. 70. See id. at 450 (noting that the “laboratory manipulation of a related SARS-CoV- like coronavirus” is unlikely and proposing natural selection as the virus’s origin). 71. Donie O’Sullivan, Exclusive: She’s Been Falsely Accused of Starting the Pandemic. Her Life Has Been Turned Upside Down, CNN (Apr. 27, 2020), https://www.cnn.com/2020/04/27/tech/coronavirus-conspiracy-theory/index.html. 72. See Andersen, supra note 67, at 452. 73. Jenny Gross & Mariel Padilla, From Flattening the Curve to Pandemic: A Coronavirus Glossary, N.Y. TIMES (Mar. 18, 2020), https://www.nytimes.com/2020/03/18 /us/coronavirus-terms-glossary.html. 74. Makin, supra note 48; Paola Verdecchia et. al., The Pivotal Link Between ACE2 Deficiency and SARS-CoV2 Infection, 76 EUR. J. INTERNAL MED. 14, 15–16 (2020).
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E. What Are the Symptoms of COVID-19?
The symptoms of COVID-19 affect individuals in a variety of ways and can range from mild to severe.75 Typically, symptoms start two to fourteen days after airborne exposure to the virus from an infected person coughing, sneezing, or even talking.76 The most common symptoms include fever, cough, and tiredness and may also include shortness of breath, achiness, runny nose, and a sore throat.77 Additional symptoms recognized by the CDC include muscle pain and a loss of taste or smell.78 Most people can manage these symptoms at home. However, the CDC recommends seeking immediate medical attention if symptoms include trouble breathing, persistent pain or pressure in the chest, new confusion or inability to be awake or awakened, or bluish lips or face.79 Increasingly, unusual symptoms identified as caused by COVID-19 include a multi-system inflammatory syndrome in children; strokes and blood clots; “COVID toes” similar to frostbite; asymptomatic low oxygen levels; gastrointestinal symptoms of appetite loss, nausea, diarrhea; and delirium in the elderly.80 Some individuals without symptoms have tested positive for the disease, indicating that asymptomatic individuals are carriers.81 Testing has been directed to developing rapid identification of IgM and IgG antibodies produced by the person’s immune system in response to the virus, detectable within one week after infection.82 As an explanation for the wide variability in symptoms, researchers at King’s College London identified six distinct types of COVID-19 as determined
75. Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavirus, CDC, https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html (last updated May 13, 2020). 76. Coronavirus Disease 2019 (COVID-19), MAYO CLINIC, https://www.mayoclinic .org/diseases-conditions/coronavirus/syc-20479963 (last visited Nov. 14, 2020). 77. Id. 78. CDC, supra note 75. 79. Id. 80. Claire Jarvis, The Unusual Symptoms of COVID-19, SCIENTIST (May 7, 2020), https://www.the-scientist.com/news-opinion/the-unusual-symptoms-of-covid-19-67522. 81. Seungjae Lee et. al., Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients with SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea, 180 JAMA INTERNAL MED. 1447, 1452 (2020). 82. Antibody Tests Key to Ending COVID-19 Lockdowns, MED. PRESS (Apr. 2, 2020), https://www.mdlinx.com/neurology/top-medical-news/article/2020/04/02/7643649.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 171 by specific clusters of symptoms.83 Certain clusters were at greater risk for requiring hospitalization and respiratory support, providing significant prognostic information.84 Another possible explanation for such variability lies in a person’s genetic makeup. An ongoing project at the Rockefeller University in New York, termed the COVID Human Genetic Effort, is examining COVID survivor genetic makeup to determine why some become so ill and others have minimal or no symptoms.85 Since its recognition in December 2019, COVID-19 has rapidly spread throughout the world, hitting every continent except Antarctica.86 It was declared a pandemic by the WHO in March 2020.87 This loosely defined term references a worldwide occurrence of a “serious new illness” that has “sustained transmission throughout the world.”88
F. Why Is COVID-19 Fatal?
As of the time of this writing, the number of COVID-19 infections worldwide is over 56 million with more than 1.3 million deaths reported and both increasing each day.89 Elderly individuals, especially those with underlying medical conditions, face the greatest risk of dying from the disease, but younger, healthy individuals have also succumbed to COVID-19.90
83. Carol H. Sudre et al., Symptom Clusters in COVID19: A Potential Clinical Prediction Tool from the COVID Symptom Study App, MEDRXIV 2 (June 16, 2020), https://www.medrxiv.org/content/10.1101/2020.06.12.20129056v1.full.pdf. 84. See id. at 9. 85. Adam Geller & Malcolm Ritter, Profile of a Killer: Unraveling the Deadly Coronavirus, STAR TRIB. (July 26, 2020), https://www.startribune.com/profile-of-a-killer- unraveling-the-deadly-new-coronavirus/571771352/. 86. See Newman, supra note 5. 87. MAYO CLINIC, supra note 76. 88. Joel Shannon, Coronavirus Has Been Declared A Pandemic: What Does That Mean, And What Took So Long?, USA TODAY (March 11, 2020), https://www.usatoday .com/story/news/nation/2020/03/11/coronavirus-pandemic-worldhealth-organization /5011903002/ (quoting Dr. Anthony Fauci at the outset of the nationwide pandemic response). 89. Global Map, COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU), JOHNS HOPKINS U. & MED., https://coronavirus.jhu.edu/map.html (last visited Nov. 18, 2020). 90. See Coronavirus Disease 2019 (COVID-19), Older Adults, CDC, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html (last updated Sept. 11, 2020); George Citroner, These Conditions Put Young People at Higher Risk for COVID-19, HEALTHLINE (Sept. 14, 2020), https://www.healthline.com/health-news/these- conditions-put-young-people-at-higher-risk-for-covid-19.
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COVID-19 can lead to sepsis and blood clotting abnormalities causing organ failure, which have been identified as associated conditions causing death.91 Some COVID-19 patients develop blood clots, and stroke-producing clots in cerebral arteries; this has occurred even though these individuals are placed on blood thinners. The problem with these patients is that clotting frequently does not react well to traditional standard methods, even in the face of the employment of high doses of blood thinners.92 Respiratory failure results from damage to the cells of the alveolar lining in the lungs so that the exchange of oxygen and carbon dioxide is impaired.93 A second reason for respiratory failure is due, paradoxically, to the body’s immune response in trying to fight the virus. An immune overreaction, possibly from a cytokine storm, causes localized hyper inflammation within the alveoli with accumulating fluid in these sacs resulting in pneumonia, further preventing the effective exchange of oxygen and carbon dioxide.94 The person literally drowns in the fluids accumulating in their lungs. Because of impaired respirations with the oxygen content of the blood dropping, these patients must be placed on a ventilator to sustain their life.95
G. Mechanical Ventilation
Mechanical ventilation is a type of life support that takes over the breathing function when a person cannot breathe independently.96 The ventilator forces oxygenated air into the individual’s lungs and removes the exhaled carbon
91. See Jesús Beltrán-García et. al., Sepsis and Coronavirus Disease 2019: Common Features and Anti-Inflammatory Therapeutic Approaches, CRITICAL CARE MED. 1 (Aug. 18, 2020), https://journals.lww.com/ccmjournal/Abstract/9000/Sepsis_and_Coronavirus_Disease _2019__Common.95525.aspx; Betsy McKay & Daniela Hernandez, Coronavirus Hijacks the Body from Head to Toe, Perplexing Doctors, WALL ST. J. (May 7, 2020), https://www.wsj.com /articles/coronavirus-hijacks-the-body-from-head-to-toe-perplexing-doctors-11588864248; see also Fei Zhou et. al., Clinical Course and Risk Factors for Mortality of Adult Inpatients with COVID-19 in Wuhan, China: A Retrospective Cohort Study, 395 LANCET 1054, 1057– 59 (2020). 92. Jeffrey Lawrence, What Is Known About COVID-19 and Abnormal Blood Clotting, WEILL CORNELL MED. (July 2, 2020), https://news.weill.cornell.edu/news/2020/07 /what-is-known-about-covid-19-and-abnormal-blood-clotting. 93. See Matthew B. Divertie, Editorial, Diffuse Alveolar Damage, Respiratory Failure, and Blood Transfusion, 59 MAYO CLINIC PROC. 643, 643 (1984). 94. Am. Thoracic Soc’y, Mechanical Ventilation, 196 AM. J. RESPIR. CRITICAL CARE 3, 3 (2017), https://www.thoracic.org/patients/patient-resources/resources/mechanical -ventilation.pdf. 95. See Carrie Macmillan, Ventilators and COVID-19: What You Need to Know, YALE MED. (June 2, 2020), https://www.yalemedicine.org/stories/ventilators-covid-19/. 96. Am. Thoracic Soc’y, supra note 94.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 173 dioxide. To do this work efficiently, the person must be intubated whereby a tube is inserted into the nose or mouth and pushed past the vocal cords and into the trachea, reaching the main branching bronchi going into each lung.97 This “endotracheal tube also allows health care workers to remove mucous from the windpipe by suction.”98 When the ventilator is connected to the endotracheal tube, filtered and humidified air with a controlled amount of oxygen is pumped through the tube by the machine. Ventilator settings can adjust the amount of oxygen, as well as the pressure and flow characteristics provided to the person.99 This pressure is referred to as “positive pressure,” and the patient usually exhales the carbon dioxide on their own unless the respirator is set to perform that task.100 The respirator sounds an alarm when the air pressure needs to be increased.101 A major risk of using a ventilator is infection, since the breathing tube may permit germs to enter the lungs.102 This danger increases the longer the patient is required to be on the mechanical ventilation, peaking around the two-week mark.103 The lungs may also be damaged “by either over inflation or repetitive opening and collapsing of the small air sacs . . . of the lungs.”104 Other potential risks include “decreased cardiac output, unintended respiratory alkalosis, increased intracranial pressure, gastric distension, and impairment of hepatic and renal function.”105 There may also be complications associated with the equipment itself including a “failure of the ventilator to cycle, of safety alarms to function properly, and of inspired gas to be properly heated or humidified.”106 Mechanical ventilation can also cause serious complications such as “pneumothorax, bronchopleural fistula, and the development of nosocomial pneumonia.”107 However, these risks may be related to the “impairment of the [patient’s] defenses and normal tissue integrity” rather than the ventilator.108 In
97. Id. 98. Id. 99. Id. 100. How Does a Ventilator Work, IDSMED (Jan. 23, 2019), https://www.idsmed.com /hk-en/news/how-does-a-ventilator-work_398.html. 101. Id. 102. Macmillan, supra note 95. 103. Mechanical Ventilation, CLEVELAND CLINIC, https://my.clevelandclinic.org/health /articles/15368-mechanical-ventilation (last visited Nov. 14, 2020). 104. Id. 105. D.J. Pierson, Complications Associated with Mechanical Ventilation, 6 CRITICAL CARE CLINIC 711, 711 (1990). 106. Id. 107. Id. 108. Id.
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174 GONZAGA LAW REVIEW Vol. 56:1 addition, miscommunication among the care team overseeing the ventilated patient can negatively impact the patient’s comfort, prognosis, and outcome.109 The majority of those on a ventilator must be monitored. This is accomplished by attaching a monitor to the patient “that measures heart rate, respiratory rate, blood pressure, and oxygen saturation.”110 Additional testing may consist of “chest x-rays and blood [tests] to measure oxygen and carbon dioxide levels” known as the blood gasses.111 This information is used to evaluate the patient’s condition and make necessary ventilator adjustments.112 The ventilator is not a source of pain, but “the tube may cause discomfort because it can cause coughing or gagging.”113 A person on a ventilator cannot talk or eat by mouth when the tube is in position.114 Sedatives and pain killers may be given to patients to make them more comfortable. In addition, a “neuromuscular blocking agent” is sometimes used in patients with a “severe lung injury” so that the ventilator can properly do its job.115
H. What Is the Treatment for COVID-19?
Presently, no vaccine is available to prevent individuals from being infected with the SARS-CoV-2 virus.116 But a vaccine appears to be on the horizon. Moderna has announced its vaccine is “nearly 95 percent effective at an early analysis.”117 Similarly, a vaccine “being developed by Pfizer and German biotechnology firm BioNTech” is 95 percent effective at preventing disease, according to a post-trial analysis.118 Accordingly, Pfizer is applying for emergency authorization from the Food and Drug Administration.119 The main thrust of treatment has been prevention by avoiding the disease and supportive care once infected. President Trump repeatedly touted hydroxychloroquine sulfate and chloroquine phosphate as an effective way to
109. See id. 110. Am. Thoracic Soc’y, supra note 94, at 3. 111. Id. 112. Id. 113. Id. 114. Id. 115. Id. at 4. 116. MAYO CLINIC, supra note 76. 117. Carolyn Y. Johnson & Laurie McGinley, Pfizer Says Its Coronavirus Vaccine Is Safe and 95% Effective and Will Seek Regulatory Review ‘Within Days,’ WASH. POST (Nov. 18, 2020), https://www.washingtonpost.com/health/2020/11/18/pfizer-covid-vaccine/. 118. Id. 119. Id.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 175 treat COVID-19, but randomized controlled studies have cast doubt on the effectiveness of these medications.120 The preventive piece to halt COVID-19 spread has been widely publicized as the population has been educated about social distancing, wearing face masks, and shelter-in-place mandates.121 Cities and states have periodically locked- down, only allowing essential businesses to stay open while closing restaurants, sporting events, schools, theaters, churches, and any congregation of people.122 Other measures include vigorous hand washing, avoiding personal contact, wearing masks, avoiding touching the face, and wiping down all packages and groceries brought into the home. All of these measures are meant to avoid community spread of the virus by airborne or contact transmission.123 Unfortunately, these preventive measures, especially the wearing of face masks, have polarized the nation and become highly politicized.124 Wearing face masks is the primary way that individuals can reduce the spread of the disease.125 Although the virus can penetrate most masks, they do block the spread of virus- laden respiratory droplets that become airborne by simply talking, laughing, or sneezing.126 Many states and cities have instituted mandates requiring use of face masks.127 While a seemingly simple measure, these mandates have angered those who view such requirements as an infringement upon their rights, leading to “viral videos of public tantrums and confrontations, partisan bickering and
120. John Travis, FDA Just Gave A Thumbs Down to Trump’s Favorite COVID-19 Drugs, SCI. (June 15, 2020), https://www.sciencemag.org/news/2020/06/fda-just-gave- thumbs-down-trump-s-favorite-covid-19-drugs. 121. Coronavirus Disease 2019 (COVID-19), Considerations for Wearing Masks, CDC, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover- guidance (last updated Aug. 7, 2020). 122. See, e.g., Press Release, Office of the Governor of Iowa, Gov. Reynolds Signs New Proclamation Continuing the State Public Health Emergency (May 26, 2020), https://governor.iowa.gov/press-release/gov-reynolds-signs-new-proclamation-continuing- the-state-public-health-emergency-4. 123. Coronavirus Disease 2019 (COVID-19), Cleaning and Disinfecting Your Home, CDC, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/disinfecting-your- home.html (last updated Sept. 8, 2020). 124. See Tina Hesman Saey, Why Scientists Say Wearing Masks Shouldn’t Be Controversial, SCI. NEWS (June 26, 2020, 11:24 AM), https://www.sciencenews.org/article /covid-19-coronavirus-why-wearing-masks-controversial. 125. CDC Calls on Americans to Wear Masks to Prevent COVID-19 Spread, CDC (July 14, 2020), https://www.cdc.gov/media/releases/2020/p0714-americans-to-wear-masks.html. 126. Id.; CDC, supra note 53. 127. See Bill Chappell, More Than 20 U.S. States Now Require Face Masks in Public, NPR (July 10, 2020, 1:32 PM), https://www.npr.org/sections/coronavirus-live -updates/2020/07/10/889691823/more-than-20-u-s-states-now-require-face-masks-in-public.
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176 GONZAGA LAW REVIEW Vol. 56:1 shaming on social media, political tirades at public meetings — and death threats.”128 This polarization has also taken on a political overtone. In Minnesota, for example, in a special session prior to Governor Walz’s mask mandate, every Democrat in the room wore a mask while none of the Republicans did.129 As summarized in a Politico article:
For progressives, masks have become a sign that you take the pandemic seriously and are willing to make personal sacrifice to save lives. Prominent people who don’t wear them are shamed and dragged on Twitter by lefty accounts. On the right, where the mask is often seen as the symbol of a purported overreaction to the coronavirus, mask promotion is a target of ridicule, a sign that in a deeply polarized America almost anything can be politicized and turned into a token of tribal affiliation.130
Some of the blame for such polarization must be accepted by the U.S. government for its inconsistencies and ambiguities. Early into the pandemic, Dr. Anthony Fauci, the White House’s chief expert on the coronavirus, stated that face masks did not need to be worn as they were not effective in preventing the spread of the disease.131 That position has been reversed since then by all medical leaders including Dr. Fauci and the CDC.132 Reluctance to wear face masks at the highest level of government has sent mixed messages to the public.133
128. Deepa Bharath, How Did Wearing Masks to Combat Coronavirus Become Such a Political Football?, ORANGE COUNTY REG., (July 5, 2020, 6:00 AM), https://www.ocregister .com/2020/07/05/how-did-wearing-masks-to-combat-coronavirus-become-such-a-political- football/. 129. Jessie Van Berkel, Face Masks Remain Symbol of Division as Gov. Tim Walz Considers Mandate, MINNEAPOLIS STAR TRIB. (July 13, 2020, 6:53 AM), https://www.startribune.com/face-masks-remain-symbol-of-division-as-gov-tim-walz-mulls- mandate/571736462/. 130. Ryan Lizza & Daniel Lippman, Wearing a Mask Is for Smug Liberals. Refusing to Is for Reckless Republicans, POLITICO (May 1, 2020, 4:30 AM), www.politico.com /news/2020/05/01/masks-politics-coronavirus-227765. 131. Saranac Hale Spencer, Outdated Fauci Video on Face Masks Shared Out of Context, FACTCHECK.ORG (May 19, 2020), https://www.factcheck.org/2020/05/outdated -fauci-video-on-face-masks-shared-out-of-context/. 132. Bharath, supra note 128. 133. See Sonam Sheth & Oma Seddiq, Trump Now Says ‘Many People Say That It Is Patriotic to Wear a Face Mask.’ Here Are 8 Times He Refused to Wear One or Downplayed Its Effectiveness, BUS. INSIDER (July 22, 2020), https://www.businessinsider.com/8-times- trump-refused-to-wear-mask-downplayed-effectiveness-2020-7.
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Fortunately, despite this polarization, a survey reports that 90% of Americans are now wearing masks in following the CDC’s recommendations.134 Once infected, individuals have mild to moderate symptoms that can be treated at home by taking pain reliever and cough medication, resting, and fluid intake as well as self-quarantine to prevent the disease from spreading.135 With respiratory distress and increasing medical difficulties, hospitalization is usually necessary for management and ventilator support.136 Even this scenario may be problematic as hospitals and their medical staff are overwhelmed with critical shortages of supplies such as personal protective equipment (PPE) and ventilators.137 In New York City, 12.2% to 33.1% of patients admitted to the hospitals with COVID-19 required intubation and mechanical ventilation.138 A sobering finding is that up to 80% of these COVID-19 patients requiring a ventilator die, and many who survive have difficulty being weaned from their ventilator.139 Further, as caregivers are infected themselves, physician and nurse shortages are critical.140 In this regard, the WHO reported that the coronavirus quickly depleted the global stockpile of supplies including masks, gowns, hand sanitizers, and gloves necessary to safeguard health care workers from infection.141 Because of these
134. Sarah Hansen, Masks Help Stop the Spread of Coronavirus, Studies Say — But Wearing Them Still a Political Issue, FORBES (June 13, 2020, 5:00 PM), https://www.forbes .com/sites/sarahhansen/2020/06/13/masks-help-stop-the-spread-of-coronavirus-studies-say- but-wearing-them-still-a-political-issue/#3f90f183604e. 135. See MAYO CLINIC, supra note 76; Treating Coronavirus at Home, U. MD. MED. SYS., https://www.umms.org/coronavirus/what-to-know/treat-covid-at-home (last visited Nov. 14, 2020). 136. See Macmillan, supra note 95. 137. Megan L. Ranney et. al., Critical Supply Shortages — The Need for Ventilators and Personal Protective Equipment During the Covid-19 Pandemic, 382 NEW ENGLAND J. MED. 18, 18 (2020). 138. Kevin Hur, Factors Associated with Intubation and Prolonged Intubation in Hospitalized Patients with COVID-19, 163 OTOLARYNGOLOGY-HEAD & NECK 170, 170 (2020). 139. Mike Stobbe, Some Doctors Moving Away from Ventilators for Virus Patients, ASSOCIATED PRESS (Apr. 8, 2020), https://apnews.com/article/8ccd325c2be9bf454c2128dcb 7bd616d. 140. Lenny Bernstein et. al., Covid-19 Hits Doctors, Nurses and EMTs, Threatening Health System, WASH. POST (Mar. 17, 2020), https://www.washingtonpost.com/health/covid -19-hits-doctors-nurses-emts-threatening-health-system/2020/03/17/f21147e8-67aa-11ea -b313-df458622c2cc_story.html; N.Y. State Task Force on Life & the Law, Ventilator Allocation Guidelines, N.Y. DEP’T HEALTH 1 (Nov. 2015), https://www.health.ny.gov /regulations/task_force/reports_publications/docs/ventilator_guidelines.pdf. 141. See Helen Branswell, Coronavirus Concerns Trigger Global Run on Supplies for Health Workers, Causing Shortages, STAT (Feb. 7, 2020), https://www.statnews.com/2020
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178 GONZAGA LAW REVIEW Vol. 56:1 shortages, people have been encouraged to reuse face masks, and there is a constant demand for more ventilators.142 After all, during a severe pandemic, those with respiratory failure that receive ventilation therapy usually survive and those who do not have access to the breathing machines will die.143
II. ETHICAL DISCUSSION
A. Ventilator Shortage
The fact that the need for life-saving mechanical ventilators in the time of a severe pandemic would far exceed the available machines has been known for years.144 The consequence of this deficit is compounded by the inability to divert existing breathing machines as many hospitals already operate at or near maximum utilization for ventilation.145 The lack of qualified technicians to distribute and operate the equipment during the coronavirus epidemic may also negatively impact ventilation utilization as qualified workers become ill or are recovering from an infection.146 Unless the availability of new ventilators dramatically increases to meet demand, difficult decisions will have to be made on how to ration this life-
/02/07/coronavirus-concerns-trigger-global-run-on-supplies-for-health-workers-causing -shortages/. 142. See Joann Muller et. al., American Manufacturing vs. the Coronavirus, AXIOS (Mar. 24, 2020), https://www.axios.com/coronavirus-face-masks-ventilators-ad633728-4574 -49da-bd23-5074ee443575.html. 143. Ventilator Document Workgroup, Ethical Considerations for Decision Making Regarding Allocation of Mechanical Ventilators During a Severe Influenza Pandemic or Other Public Health Emergency, CDC 5 (July 1, 2011), https://www.cdc.gov/about /advisory/pdf/VentDocument_Release.pdf. An important issue that is beyond the scope of this paper is the legality of the stay at home orders and shuttering of non-essential business. Public health officials’ decisions to implement intrusive actions are given deference during pandemics. This deference, however, is not unlimited. Courts still mandate that these intrusive actions be “necessary”; they must be narrowly tailored “in their intrusiveness, duration, and scope — to achieve their goal”; and the intrusive actions “must not be used to attack ostracized groups.” David Studdert & Mark Hall, Disease Control, Civil Liberties, and Mass Testing — Calibrating Restrictions during the Covid-19 Pandemic, 383 NEW ENG. J. MED. 102, 102–03 (2020), https://www.nejm.org/doi/full/10.1056/NEJMp2007637. As a caveat, this general statement must be tempered by the limitation that this historical experience with quarantines offers little real-world advice because of the unique characteristics of COVID-19 and the public health doctrines that it has evoked. Id. at 103. 144. See Daniel Patrone & David Resnick, Pandemic Ventilator Rationing and Appeals Processes, 19 HEALTH CARE ANALYSIS 165, 165–66 (2011). 145. See id. at 166. 146. See id.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 179 saving equipment—decisions that have life and death consequences.147 For instance, should a person with a serious or terminal health issue be prioritized or should they give way to someone with no underlying health issues? Does working in a healthcare facility give a person an earlier spot in line? Should pregnancy, incarceration, or undocumented status factor into the equation, and, if so, how?148 In a normal ICU environment, a patient on a ventilator stays on the device until a physician determines that the patient is improving.149 The COVID-19 pandemic, however, could force doctors into making difficult choices.150 If multiple patients are waiting for a single ventilator in the emergency room, a patient on a ventilator with a poor prognosis may be removed from the equipment even though that patient will likely die.151 Logically, if a patient is not improving, and the use of the ventilator appears to be a poor utilization of the equipment, the physician will use the breathing machine on another patient who has a better prognosis.152 The dramatic increase in the use of ventilators will also likely lead to more machine breakdowns, mistakes, and adverse consequences. The coronavirus pandemic presents difficult legal and ethical issues, and little attention has been devoted to these liability concerns. But these issues cannot be ignored, because whenever there is “an adverse health outcome because of the need to ration healthcare services or the need for healthcare providers to work outside of their normal professional responsibilities, healthcare personnel and organizations may be subject to professional liability lawsuits or other legal challenges.”153 These breathing machines have also become “one of the most politicized” and requested medical supplies in the United States as coronavirus cases increase and hospitals prepare for the increase of patients.154
147. Ariana Eunjung Cha, Spiking U.S. Coronavirus Cases Could Force Rationing Decisions Similar to Those Made in Italy, China, WASH. POST (Mar. 15, 2020, 4:05 PM), https://www.washingtonpost.com/health/2020/03/15/coronavirus-rationing-us/. 148. Id. 149. Christopher Cheney, 4 Ethical Dilemmas for Healthcare Organizations During the COVID-19 Pandemic, HEALTHLEADERS (Mar. 18, 2020), https://www.healthleadersmedia .com/clinical-care/4-ethical-dilemmas-healthcare-organizations-during-covid-19-pandemic. 150. Id. 151. Id. 152. Id. 153. Patrone & Resnick, supra note 144, at 173. 154. Jaimy Lee, Soaring Demand for Ventilators Creates Political Tension, Promises to Ramp Up Manufacturing, MARKETWATCH (Mar. 29, 2020, 11:46 AM), https://www .marketwatch.com/story/soaring-demand-for-ventilators-creates-political-tension-promises -to-ramp-up-manufacturing-2020-03-25.
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While much disinformation was disseminated at the onset of the pandemic, such as the coronavirus was no worse than the flu or that it would be short-lived,155 numerous warnings were issued during the past decade about the potential for such an outbreak and that the country was ill-prepared to deal with such a crisis.156 Out of all the equipment that will be in short supply, mechanical ventilators are of the highest concern.157 The shortage of mechanical ventilators is particularly widespread in developing countries.158 These countries not only have fewer resources and qualified personnel to deal with the increased number of patients but also will face even greater demands during a severe pandemic.159 In the United States, it is estimated that there will be thirty- one patients vying for each available machine.160 China determined that between 2– 6% of patients with the virus required ventilation, and hospitals in Italy were forced to deny life-saving care to patients in poor condition because of the shortage of ventilators.161 It is estimated that American hospitals possess about 62,000 full-function ventilators and about 98,000 basic units, while the federal government maintains a stockpile of an additional 8,900 machines.162 Yet the CDC projects that between 2.4 to 21 million people in the United States will need to be hospitalized because of the coronavirus, and 10-25% of these patients will need ventilation.163 Some have predicted that the country may need as many as 750,000 ventilators for the COVID- 19 pandemic.164 In this regard, Governor Andrew Cuomo asserted that New York
155. Katelyn Burns, Trump’s 7 Worst Statements on the Coronavirus Outbreak, VOX (Mar. 13, 2020, 8:02 AM), https://www.vox.com/policy-and-politics/2020/3/13/21176535 /trumps-worst-statements-coronavirus. 156. See Robin Marantz Henig, Experts Warned of a Pandemic Decades Ago. Why Weren’t We Ready?, NAT’L GEOGRAPHIC (Apr. 8, 2020), https://www.nationalgeographic.com /science/2020/04/experts-warned-pandemic-decades-ago-why-not-ready-for-coronavirus /#close. 157. Truog et al., supra note 6, at 1973. 158. Dale Whittington & Xun Wu, Why Coronavirus Lockdowns Will Not Be Easy for Developing Countries, and What They Can Learn, S. CHINA MORNING POST (Mar. 30, 2020, 7:30 PM), https://www.scmp.com/week-asia/opinion/article/3077552/why-coronavirus -lockdowns-will-not-be-easy-developing-countries. 159. Patrone & Resnik, supra note 144, at 166. 160. Soumya Karlamangla et. al., Who Lives and Who Dies? With Ventilators Limited Amid Coronavirus, Doctors Might Face Hard Choices, L.A. TIMES (Mar. 26, 2020), https://www.latimes.com/science/story/2020-03-26/coronavirus-ventilator-shortage-choice -health-care-doctors. 161. Id. 162. Truog et al., supra note 6, at 1973. 163. Id. at 1973–74. 164. Lee, supra note 154.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 181 alone will need 40,000 ventilators and that the state only had 4,000 units when the pandemic started.165 California has 4,000 machines but sought at least 10,000 ventilators166 while Michigan has 1,700 but needs almost 10,000.167 This shortage has resulted in states bidding against each other for these life-saving devices thereby driving up the price of the equipment from $25,000 to $40,000 per unit.168 This bidding war is the result of the lack of a coordinating committee among the states and the federal government to acquire ventilators.169 Public health officials tried to prevent this anticipated ventilator crisis thirteen years ago when they attempted to secure more machines. The idea “was to build a large fleet of inexpensive portable devices” that would cost less than $3,000 and be used during a health crisis.170 A federal contract was executed and the money budgeted, but the project went awry after a large medical supplier purchased the firm selected to make the new units.171 This development resulted in a five-year delay in the design of a new machine thereby depriving hospitals as well as the federal and state governments of the ability to build up an inventory of ventilators.172 The process was restarted with a new company in 2014, but their design was not approved until 2019 and no units were delivered as of March
165. Geoff Herbert, Cuomo Refutes Trump, Insists NY Needs Up to 40,000 Ventilators: “I Operate on Facts”, SYRACUSE (Mar. 27, 2020), https://www.syracuse.com /coronavirus/2020/03/cuomo-refutes-trump-insists-ny-needs-up-to-40000-ventilators-i -operate-on-facts.html. 166. Nigel Duara & Ana B. Ibarra, California Ramps Up Output of Ventilators as COVID-19 Cases Grow, CAL MATTERS (Mar. 29, 2020), https://calmatters.org/health /coronavirus/2020/03/newsom-california-can-produce-enough-ventilators-to-meet-covid-19- need/. 167. Riley Beggin, Michigan May Need Another 8,000 Ventilators as Coronavirus Outbreak Worsens, BRIDGE MICH. (Mar. 30, 2020), https://www.bridgemi.com/michigan- health-watch/michigan-may-need-another-8000-ventilators-coronavirus-outbreak-worsens. 168. Amy Feldman, States Bidding Against Each Other Pushing up Prices of Ventilators Needed to Fight Coronavirus, NY Governor Cuomo Says, FORBES (Mar. 28, 2020, 1:23 PM), https://www.forbes.com/sites/amyfeldman/2020/03/28/states-bidding-against -each-other-pushing-up-prices-of-ventilators-needed-to-fight-coronavirus-ny-governor- cuomo-says/#626d6b82293e. 169. Id. 170. Nicholas Kulish et al., The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed., N.Y. TIMES (Apr. 20, 2020), https://www.nytimes.com/2020/03/29/business /coronavirus-us-ventilator-shortage.html. 171. Id. 172. Id.
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2020.173 Given this history, there is little wonder why the United States is facing the current shortage of ventilators.
B. Allocating Resources
The coronavirus outbreak in the United States is more complex than in most countries because of the nation’s “diversity, deep political and economic divisions and decentralized decision-making.”174 The CDC has developed “general principles” for apportioning limited materials during the COVID-19 pandemic, but it defers to the states for implementation.175 As a result, some states advocated for using ethical principles to ascertain need, while others argued for a point score system based on a patient’s health, past medical history, and age.176 Most people believe a utilitarian plan is the best approach. This plan, however, changes based upon the period, setting, and culture.177 When a public health emergency arises, “federal, state, and local stockpiled ventilators should be deployed in a way that optimizes the effectiveness, efficiency, and equity of this important scarce resource.”178 It is equally important to ensure that the “sufficient staff and space to care for as many patients as possible who require ventilation.”179 In this regard, legal scholars have informed medical institutions and providers about their duty to develop detailed plans for dealing with large numbers of critically ill patients during mass casualty incidents.180 Physicians will be expected to emphasize maximizing population-based results instead of improving the health of specific people. This shift to a public health focus may mandate that health care providers sacrifice “best practices or provid[e] less than optimal care to individual patients.”181
173. Id. The Food and Drug Administration has issued new rules that allow changes to existing machines or manufacturing lines to speed up the production of the ventilators. These rules also permit hospitals to use ventilators from other places, such as ambulances, and other devices, such as continuous positive airway pressure machines used to treat sleep apnea. Lee, supra note 154. 174. Cha, supra note 147. 175. Id. 176. Id. 177. Id. 178. Lisa M. Koonin et al., Strategies to Inform Allocation of Stockpiled Ventilators to Healthcare Facilities During a Pandemic, 18 HEALTH SEC. 69, 70 (2020). 179. Id. 180. Id. 181. Eleanor D. Kinney et al., Altered Standards of Care for Heath Care Providers in the Pandemic Influenza, 6 IND. HEALTH L. REV. 1, 11 (2009).
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C. Other Ethical Considerations
There may come a time when hospitals will have to make difficult decisions on how to ration ventilators. Some say that ethical principles should be the guide for ventilator allocation based upon “respect for persons and their autonomy, beneficence . . . , and justice.”182 This first principle, deference and respect to patients and their autonomy, mandates doctors secure a person’s informed consent and honor any informed refusal.183 Normally, it is rare to stop or deny mechanical ventilation without the patient’s or surrogate’s consent.184 In the case of a severe pandemic, however, public health orders may supersede patient autonomy. If a health emergency is announced and emergency guidelines are activated, health care professionals may be constrained by other mandates.185 Therefore, not all those in respiratory distress will be able to receive ventilation. Under all circumstances, however, patients must still be “treated with dignity and compassion” and provided palliative care.186 Five years ago, the CDC, as part of a Pandemic Influenza Readiness Assessment drill, evaluated all Public Health Emergency Preparedness jurisdictions to determine their ability to handle a pandemic.187 The CDC asked certain jurisdictions to identify critical factors for determining how they would allocate ventilators to hospitals during a pandemic.188 The results from this exercise revealed that about 65% of the jurisdictions surveyed had performed a hospital-based assessment to determine their mechanical ventilation capabilities, and 48% had not decided when or how they would teach healthcare providers to use the stockpiled ventilators.189 The guidelines the CDC developed require many preparedness efforts such as planning at the local, state and institutional levels. Ethical considerations should include a plan for how to allocate scarce ventilators, the need for transparency which seeks input from the public, the duty of care to be exercised by a reasonable physician in an emergency, a duty to allocate limited resources
182. E.g., Ventilator Document Workgroup, supra note 143, at 10. 183. Id. 184. Id. 185. Id. 186. Id. 187. Koonin et al., supra note 178, at 70. 188. Id. 189. Id.
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184 GONZAGA LAW REVIEW Vol. 56:1 to those who can best utilize the machines, and fairness in the allocation of stockpiled ventilators.190
III. LEGAL DISCUSSION
The spread of COVID-19 has raised numerous legal issues, ranging from allocating ventilators to medical licensing. A variety of approaches have been suggested regarding how to deal with a national medical emergency and the shortage of much needed medical equipment. These issues have generally been addressed on the state level, and state responses and plans vary in detail, as discussed below.
A. State Responses
While no protocol exists on a national level for rationing ventilators,191 many states have had the foresight to anticipate this shortage and have published guidelines for the allocation of ventilators and other supplies. A review of these state pandemic preparedness plans shows that only thirteen of the forty-nine plans discuss ventilator allocation, and eight of those plans reference the need to develop ventilator rationing plans or note that a future plan will be developed.192 A mere five states developed protocols or procedures for rationing ventilators.193 New York has the most proactive plan and issued a comprehensive 266-page guide on how to prioritize allocating ventilators, which has been widely cited and adopted by other states.194 These recommendations examine how to prioritize
190. Id. at 73. The AMA has issued an ethics opinion on the duty of a physician during a disaster. It provides that “[b]ecause of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters. This ethical obligation holds even in the face of greater than usual risks to their own safety, health or life. The physician workforce, however, is not an unlimited resource; therefore, when participating in disaster responses, physicians should balance immediate benefits to individual patients with ability to care for patients in the future.” Virtual Mentor, Opinion 9.067 – Physician Obligation in Disaster Preparedness and Response, 12 AMA J. Ethics, 459, 459 (2010). 191. Keith Griffith, New York Hospitals Could Use LOTTERIES for Ventilators in an Extreme Shortage During Coronavirus Emergency – and Other States Plan to DENY Access to Those with Cancer or a Mental Disability, DAILY MAIL (Mar. 28, 2020), https://www.dailymail.co.uk/news/article-8162357/US-coronavirus-New-York-hospitals -guidance-use-LOTTERIES-ventilators-shortage.html. 192. Patrone & Resnik, supra note 144, at 168. 193. Id. 194. See N.Y. State Task Force on Life & the Law, supra note 140, at 1.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 185 ventilators among adults, children, and infants during a pandemic.195 This working document offers a framework for making decisions based on several ethical principles:
• Duty to care: respecting the fundamental obligation of health care providers to care for patients[;]
• Duty to steward resources, duty to plan, and distributive justice: preventing inequities by devising a just system in advance for allocating ventilators in a time of critical shortage[; and]
• Transparency: engaging in clear, consistent communication among health care providers, patients, their families, and the general public[.]196
The New York Task Force considered several “nonclinical approaches” for distributing ventilators.197 Approaches included providing ventilators on a “first- come-first-served basis,” distributing based on a lottery system, exclusively relying on “informal clinical” opinions to determine ventilator allocation, and “prioritizing certain patient categories, such as health care workers, older patients, and those with certain social criteria.”198 These approaches were wisely rejected in favor of a system that assigned the lowest priority to those who had the best chance of survival without medical intervention as well as those who had the smallest chance of survival even with medical intervention.199 This allocation method was thought to be the best way to increase the overall number of survivors.200 Treating physicians were removed from the decision-making process so that they could focus solely on their duty of care.201 Instead, a triage officer or committee would make the ventilator assignment decisions based upon the information provided by the treating doctor and the employment of a three-step
195. Susie A. Han & Valerie Gutmann Koch, Allocate Ventilators, Other Covid-19 Resources Based on Evidence, Not Political Hunches, STAT (Mar. 17, 2020), https://www.statnews.com/2020/03/17/allocate-ventilators-other-covid-19-resources-based -on-evidence/. 196. Id. 197. Id. 198. Id. 199. See N.Y. State Task Force on Life & the Law, supra note 140, at 4–5. 200. Id. at 4. 201. Id. at 5.
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186 GONZAGA LAW REVIEW Vol. 56:1 process.202 The first step requires the removal of patients based upon an exclusion list for those who have “a short life expectancy irrespective of their current acute illness.”203 In the second step, a mortality risk assessment is performed based upon a clinical scoring method that exams the person’s organs and systems such as the lungs, brain, liver, and kidneys.204 The third step involves a time trial that assesses the patient after 48 hours and again after 120 hours of ventilator therapy to determine whether treatment should continue based upon the effectiveness of the care.205 Minnesota enacted a detailed plan for scarce resource management that covers a wide array of issues such as the shortage of oxygen, staffing, nutritional support, medication administration, and mechanical ventilation.206 These guidelines assess the patient’s overall health based upon a score entitled a Sequential Organ Failure Assessment, which examines organ system function, the patient’s prognosis, duration of ventilation needs, and response to the breathing machine.207 This is not a standalone determination but is to be used in combination with other factors to compare patients needing the resource. Illustrations of underlying medical issues that are a precursor for poor short-term survival include congestive heart failure; severe chronic lung disease, central nervous system, solid organ, or hematopoietic malignancy with a poor prognosis for recovery; cirrhosis; and acute hepatic failure.208 Tennessee established guidelines in 2016 premised upon giving priority to patients for whom treatment “would most likely be lifesaving and whose functional outcome would most likely improve with treatment.”209 These
202. Id. at 5–6. 203. Id. at 14. 204. Id. 205. Id. These guidelines were the subject of criticism by Donald Trump against Governor Cuomo when the President misleadingly asserted that the Governor rejected a 2015 recommendation to buy 15,000 ventilators and instead “established death panels” and “lotteries.” Glenn Kessler & Salvador Rizzo, Trump’s Faux Facts on Fox News, WASH. POST (Mar. 26, 2020, 12:00AM), https://www.washingtonpost.com/politics/2020/03/26/trumps -faux-facts-fox-news/. At no time did the Guidelines discuss the purchase of additional ventilators and the triage committee is not a death panel but a way to make rational decisions concerning ventilator allocation. See id. 206. Patient Care Strategies for Scarce Resource Situations, MINN. DEP’T HEALTH (May 2020), https://www.health.state.mn.us/communities/ep/surge/crisis/standards.pdf. 207. Id. § 6-2. 208. Id. 209. Guidance for the Ethical Allocation of Scarce Resources During a Community- Wide Public Health Emergency as Declared by the Governor of Tennessee, TENN. ALTERED STANDARDS CARE WORKGROUP 8 (July 2016), https://int.nyt.com/data/documenthelper/6851 -tennessee-triage-guidelines/02cb4c58460e57ea9f05/optimized/full.pdf.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 187 individuals should be given priority over patients that “would likely die even with treatment” and patients who “would most likely survive without treatment.”210 Interestingly, Tennessee’s guidelines specifically incorporate the plan established by Minnesota.211 Utah has established triage guidelines in case of a pandemic.212 These directives break triage down into three categories depending upon the severity of the illness.213 The lowest priority for admission to the hospital is assigned to those with the worst chance of survival regardless of treatment and individuals with the best odds of survival without medical intervention.214 The judgment of the treating physician will be utilized in applying these guidelines.215 Patients are excluded from hospital admission if certain conditions are present, such as the patient is known to be on “Do Not Resuscitate” status, the patient has a severe and irreversible neurological condition, severe burns with less than a 50% chance of survival, severe dementia, advanced untreatable neuromuscular disease, incurable metastatic malignant disease, or end-stage organ failure.216 In 2018, Colorado implemented an All Hazards Internal Emergency Response and Recovery Plan.217 This plan is designed to offer comprehensive guidance and support to help manage a disaster or emergency that threatens the healthcare of its citizens to maximize patient survival.218 The overriding principle is one of fairness in providing care without regard to things such as “race, ethnicity, socioeconomic status, disability or [body] region[s] that are medically irrelevant.”219 This plan also references the guidelines established by Minnesota in determining its plan of action concerning medication resource allocation.220
210. Id. 211. See id. at 4. 212. Utah Hosp. & Health Sys. Ass’n, Utah Pandemic Influenza Hospital and ICU Triage Guidelines for Adults, UTAH DEP’T HEALTH 1 (Jan. 28, 2010), https://health.utah.gov /preparedness/downloads/medical_care_triage_app9.pdf. 213. Id. at 4. 214. Id. 215. Id. at 3. 216. Id. at 5. 217. CDPHE All Hazards Internal Emergency Response and Recovery Plan, Annex B: Colorado Crisis Standards of Care Plan, COLO. DEP’T PUB. HEALTH AND ENV’T 1 (July 10, 2018), https://cha.com/wp-content/uploads/2018/10/Crisis-Standards-of-Care-05102018 -FINAL.pdf. 218. Id. at 2. 219. Id. at 11. 220. See id. at 43–44.
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Some state plans, such as Alabama’s and Washington’s, exclude people with certain disabilities or conditions from accessing ventilators during a public health crisis.221 For instance, Alabama’s Emergency Operations Plan excludes people who have advanced dementia, cancer that has metastasized, AIDS, or “severe mental retardation” from using a ventilator.222 These restrictions prompted the filing of a federal civil rights complaint on the basis that the plan would discriminate against the disabled and place them in imminent danger during the coronavirus pandemic.223 It is asserted that this policy violates federal law prohibiting discrimination against the disabled.224 A similar complaint was lodged against Washington State asserting that its ventilation plan “violates the rights of people with disabilities and puts their lives at risk.”225 Washington State issued a guidance document recommending triage teams who will contemplate transferring those with “loss of reserves in energy, physical ability, cognition and general health to outpatient or palliative care facilities.”226 These lawsuits prompted the director of the federal Office of Civil Rights to launch an investigation “to ensure that states [do] not allow medical providers to discriminate on the basis of disabilities, race, age, or certain other factors when deciding who would receive lifesaving medical care during the coronavirus emergency.”227 Pennsylvania’s draft medical treatment rationing plan during COVID-19 was also subject to a civil rights lawsuit that claimed the plan discriminated against the disabled.228 The plaintiff alleges the draft gives disproportionate weight “to life expectancy and quality of life in deciding who gets care.”229 The proposal created a
221. Minyvonne Burke, Ventilators Limited for the Disabled? Rationing Plans Are Slammed Amid Coronavirus Crisis, NBC (Mar. 27, 2020, 11:34 AM), https://www.nbcnews .com/news/us-news/ventilators-limited-disabled-rationing-%20plans-are-slammed-amid -coronavirus-crisis-n1170346. 222. Matthew Impelli, Alabama Plan Could Restrict Ventilator Access for People with Advanced Dementia, Severe Cancer and Other Conditions, NEWSWEEK (Mar. 25, 2020, 4:51 PM), https://www.newsweek.com/alabama-plan-could-restrict-ventilator-access-people -advanced-dementia-severe-cancer-other-1494319. 223. Burke, supra note 221. 224. Id. 225. Id. 226. Id. 227. Sheri Fink, U.S. Civil Rights Office Rejects Rationing Medical Care Based on Disability, Age, N.Y. TIMES (Mar. 28, 2020), https://www.nytimes.com/2020/03/28/us /coronavirus-disabilities-rationing-ventilators-triage.html. 228. Harold Brubaker, Activists Say Pennsylvania’s Critical-Care Guidelines Discriminate Against the Disabled for COVID-19 Care, PHILA. INQUIRER (Apr. 8, 2020), https://www.inquirer.com/business/health/disability-rights-pennsylvania-complaint-triage -guidelines-covid-19-20200408.html. 229. Id.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 189 point system with patients being penalized if they have conditions such as “Alzheimer’s, heart failure, or other major illnesses associated with decreased long- term survival.”230 Nevada has amended its laws to deal specially with COVID-19.231 To allow more health care workers to render care, the state has authorized its professional licensing boards to temporarily waive certain licensing requirements during the COVID-19 pandemic to permit practice by currently unlicensed skilled medical professionals.232 It also extended its governmental immunity laws to all providers of medical services related to the coronavirus unless the person engaged in willful misconduct, gross negligence, or acted in bad faith.233 New York State Governor Cuomo issued a temporary Executive Order to ensure that New York State has sufficient hospital beds, supplies, and healthcare professionals to treat those affected with COVID-19, as well as patients afflicted with other illnesses.234 To achieve this goal, the Governor provided immunity to licensed healthcare individuals who: (1) provide medical services in support of the state’s response to COVID-19; (2) act reasonably and with good faith in recordkeeping; (3) come out of retirement without current registrations to provide medical care; (4) travel to New York from another state to assist in the COVID-19 efforts; among other immunities.235 Illinois has enacted a similar order.236 That state’s governor issued an Executive Order “granting health care providers . . . immunity from civil liability for any injury or death that occurs while they provide health care services” during the COVID-19 pandemic, “unless the provider acts in a grossly negligent manner or engages in willful misconduct.”237 Illinois’s Executive Order “covers employees and volunteer workers at such health care facilities.”238
230. Id. 231. NEV. REV. STAT. § 414.110 (2020). 232. See id. § 414.110(2). 233. See id. § 414.110(1). 234. N.Y. Exec. Order No. 202.10 (Mar. 23, 2020). 235. Id. 236. See Ill. Exec. Order 2020-19 (Apr. 1, 2020). 237. Robert K. Neiman, Pritzker Grants Health Care Facilities Civil Liability Immunity During COVID-19 Crisis Absent Gross Negligence or Willful Misconduct, NAT’L L. REV. (Apr. 2, 2020), https://www.natlawreview.com/article/pritzker-grants-health-care-facilities -civil-liability-immunity-during-covid-19. 238. Id.
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B. Federal Laws
States have power to adopt public health laws during a public health emergency.239 However, state public health laws concerning the allocation of supplies during a public health emergency must comply with federal law.240 There is a lack of legislation and case law addressing ventilator allocation.241 In the past, “limitations placed upon fundamental rights in [an] emergency have often been justified when such restrictions are found to benefit the population as a whole.”242 Examples include laws mandating vaccinations, limiting public gathering during disease outbreaks, and measures dealing with the containment of AIDS.243 Courts have allowed states to infringe on citizens’ rights when required to protect public health.244 As for federal laws that provide some degree of liability protection to health care providers during a health emergency, the Public Readiness and Emergency Preparedness Act (PREP) and the Volunteer Protections Act of 1997 (VPA) are the most relevant.245 PREP permits the Secretary of the Department of Health and Human Services (HHS) to issue a declaration that grants covered persons immunity from liability claims “resulting from the administration or use of countermeasures to prevent diseases, threats and conditions” that create “a present, or credible risk of a future public health emergency.”246 This immunity, however, is not applicable to claims arising from willful misconduct.247 A covered person includes those “involved in the development, manufacture, testing, distribution, administration, and use of any countermeasures.”248 A declaration under the PREP Act does not require any other emergency declaration to be effective.249
239. See Jacobson v. Mass., 197 U.S. 11, 26–28 (1905). 240. U.S. CONST. art. VI; see also N.Y. State Task Force on Life & the Law, supra note 140, at 206. 241. N.Y. State Task Force on Life & the Law, supra note 140, at 207. 242. Id. at 207. 243. Id. at 207–08. 244. Id. at 208. 245. Valerie Gutman Koch & Beth E. Roxland, Unique Proposals for Limiting Legal Liability and Encouraging Adherence to Ventilator Allocation in an Influenza Pandemic, 14 DePaul J. Health Care L. 467, 476 (2013). 246. Public Readiness and Emergency Preparedness Act, U.S. DEP’T HEALTH & HUMAN SERV., https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx (last updated Aug. 24, 2020). 247. Id. 248. Id. 249. Id.
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If a provider’s actions relating to supplies and ventilators are part of a designated response initiative under a declaration issued by the Secretary of HHS, the utilization of these supplies and ventilators should be covered by PREP.250 There is some disagreement, however, over whether ventilators would be covered under PREP.251 The VPA insulates certain volunteers from liability.252 The legislation primarily applies to volunteers of nonprofit organizations and is “designed to extend traditional charitable immunity, sovereign immunity, and Good Samaritan laws found at the state levels to the federal level.”253 The VPA only applies to those who volunteer and not to the organization for which they work.254 Under the VPA, there is also a limitation that the volunteer cannot receive more than $500 per year in compensation from the organization and the law will not provide immunity for “willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safety of the individual harmed by the volunteer.”255 While the VPA preempts inconsistent state law, it does not “preempt any State law that provides additional protection from liability relating to volunteers . . . .”256 It should be noted that physicians who are required to work at a hospital equipped with an emergency room may face fines of up to $50,000 for not offering necessary screening or stabilizing treatment in an emergency under the Emergency Medical Treatment and Active Labor Act (EMTALA).257 In cases of multiple violations, the health care provider can even be barred from partaking in the Medicare initiative.258 The EMTALA does not exempt a doctor from providing treatment because of a fear of contacting a virus.259
250. See Koch & Roxland, supra note 245, at 476. 251. Id. at 476–77 ([A]lthough there is a strong argument that the establishment of a triage protocol for ventilators in a pandemic qualifies as a program for ‘the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product,’ it remains unclear whether a ventilator would qualify as a covered countermeasure.”). 252. See Volunteer Protection Act of 1997, 42 U.S.C. §§ 14501–14505. 253. Rebecca Mowrey & Adam Epstein, The Little Act that Could: The Volunteer Protection Act of 1997, 13 J. LEGAL ASPECTS SPORT 289, 290 –91 (2003). 254. Id. at 290. 255. Koch & Roxland, supra note 245, at 477–78. 256. 42 U.S.C. § 1405(b). 257. 42 U.S.C. §§ 1395dd(a)–(b), (d)(1)(B); see also Carl H. Coleman, Beyond the Call of Duty: Compelling Health Care Professionals to Work During an Influenza Pandemic, 94 IOWA L. REV. 1, 20 (2008). 258. 42 U.S.C. § 1395dd(d)(1)(B). 259. See Coleman, supra note 257, at 20.
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C. Legal Issues
1. Altered Standard of Care
The coronavirus raises many liability questions.260 The shortage of ventilators and other critical supplies may result in unneeded patient deaths. The actions of physicians who deprive patients of a mechanical ventilator or remove a patient from the machine to give it to another will be questioned and may face suit by the aggrieved party. Another issue concerns the liability of a medical institution that runs out of ventilators when shortages of these life-saving devices had been predicted for years before the pandemic. A medical institution has a duty to maintain its facility and have the necessary equipment and supplies on hand to properly carry out its mission.261 As noted in Kirby v. State, a hospital should deliver and maintain sufficient provisions as well as competent personnel to provide proper care to its patients.262 A hospital’s failure to provide these needed services during a medical emergency can result in liability.263 A question, therefore, arises as to whether physicians “should be held to a lower standard of care during medical emergencies.”264 The meaning of “standard of care” varies “depending on the context.”265 In medicine, it indicates the standards created by the profession setting forth “acceptable and appropriate practice[s].”266 The phrase has a different connotation in the law, where it denotes a legal standard that must be followed to evade legal liability.267 While the exact requirements vary by jurisdiction, the standard of care for physicians generally means that they must use the “care and skill which is expected of a reasonably competent practitioner in the same class to which he
260. See generally Teneille R. Brown, When the Wrong People are Immune, J.L. BIOETHICS (May 8, 2020), https://doi.org/10.1093/jlb/lsaa018 (discussing liability for various COVID-19 responders). 261. Mindy Nunez Duffourc, Repurposing the Affirmative Defense of Comparative Fault in Medical Malpractice, 16 IND. HEALTH L. REV. 21, 28 (2018). 262. Kirby v. Louisiana ex rel La. State Univ. Bd. of Supervisors, 2014-0017, p. 8 (La. App. 1 Cir. 11/7/14); 174 So. 3d 1, 8. 263. See Michael Abramowicz, Hospital Liability for Ventilator Shortages, VOLOKH CONSPIRACY (Mar. 28, 2020), https://reason.com/2020/03/28/hospital-liability-for-ventilator -shortages/. 264. Id.; see also Rebecca Mansbach, Altered Standards of Care: Needed Reform for When the Next Disaster Strikes, 14 J. HEALTH CARE L. & POL’Y 209, 212–213 (2011). 265. Kinney et al., supra 180 at 2. 266. Id. 267. Id.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 193 belongs acting in the same or similar circumstances.”268 During a pandemic’s surge period, when the medical emergency experiences the most infected people and the need for resources and services is at its apex,269 the medical challenges will be enormous. Medical institutions and physicians are not prepared “for a surge at any level” let alone at the numbers expected during a pandemic.270 In this regard, a medical institution can function at 125% capacity for only a short time—most cannot sustain this elevated level of service for more than three days.271 Following Hurricane Katrina and the H1N1 pandemic, some suggested changing the required duty of care during an emergency to an “altered standard of care,” in which a different criterion would apply to health care workers.272 Generally, a public health emergency occurs when the “scale, timing or unpredictability [of a crisis] threatens to overwhelm routine capabilities.”273 Most legal professionals are aware of the modification of negligence laws for volunteers and Good Samaritans who assist during an emergency.274 Many of these laws provide immunity to these individuals or hold that they are only liable for gross negligence.275 Physicians should be encouraged to assist during an emergency even though they may not be able to offer the same quality of care that one would ordinarily provide by way of professional norms.276 However, this scenario is much different from whether health care providers should anticipate emergencies and have the necessary supplies on hand to handle the added demand.277 In most jurisdictions, the “trigger” for traditional standards of care to be altered is a declaration by the President,278 governor or local leader of a public
268. Id. at 4–5. 269. Id. at 10. 270. Id. (discussing medical institution capacity during influenza pandemic). 271. Id. 272. Mansbach, supra note 264, at 209. 273. Id. 274. See id. 275. See Sharona Hoffman, Responders’ Responsibility: Liability and Immunity in Public Health Emergencies, 96 GEO. L. J. 1913, 1943–44 (2008). 276. Abramowicz, supra note 263. 277. Id. 278. The President can declare a state of emergency under the Robert T. Stafford Disaster Relief and Emergency Assistance Act and the National Emergencies Act. See Stephen Seely, The Home-Field Disadvantage: Tort Liability and Immunity for Paid Physicians During Disasters Within the Pacific Northwest Emergency Management Arrangement Member States, 40 SEATTLE U. L. REV. 875, 881 (2017).
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194 GONZAGA LAW REVIEW Vol. 56:1 health emergency.279 This pronouncement presents important liability questions to those who help in a medical emergency.280 Several jurisdictions protect healthcare responders in these situations from liability if they follow the edicts delivered by public health agencies.281 But some states, like Kansas, do not offer this liability protection to hospitals and health care workers.282
2. Duty of Care Laws in an Emergency
Several new or existing laws offer a degree of protection against malpractice claims involving volunteers and other health care professionals during an emergency medical declaration.283 These laws create a mixture of liability defenses and protections that depend on the type of services provided, such as whether the individual is a volunteer or paid employee, and the degree of safeguards offered by the program under which the individual is participating in rendering the care.284 A declaration of an emergency grants government officials exceptional powers during a crisis. However, this extraordinary power may result in driving a wedge between public and private medical practitioners.285 Following the “declaration of an emergency, disaster, or public health emergency . . . , medical practitioners who are a part of the government response to the disaster or emergency, or who acting in a voluntary capacity, are given special immunities” and protections as long as their actions are not criminal, willful, or grossly negligent.286 On the other hand, physicians who are paid for their services have
279. See id. at 880; Gianfranco Pezzino, Guide for Planning the Use of Scarce Resources During a Public Health Emergency in Kansas, KAN. HEALTH INST. vi (Sept. 2009), http://www.kdheks.gov/cphp/download/GuideforPlanningUseofScarceResources.pdf. 280. Pezzino, supra note 279, at vi. 281. Id. 282. Id. 283. Key Emergency Authority and Immunity Concepts, ASS’N ST. & TERRITORIAL HEALTH OFFICIALS, https://www.astho.org/Programs/Preparedness/Public-Health-Emergency -Law/Emergency-Authority-and-Immunity-Toolkit/Key-Emergency-Authority-and- Immunity-Concepts/ (last updated May 2013). 284. Id. 285. Seely, supra note 278, at 880. 286. Id. at 880, 882. See generally 42 U.S.C. § 247d(a) (granting the Secretary of Health and Human Services authority to declare a public health emergency); 42 U.S.C. § 300hh-11 (establishing the National Disaster Medical System); 42 U.S.C. §§ 14501-05 (modifying liability rules for volunteers); ALASKA STAT. § 09.65.090 (modifying liability rules for emergency medical aid); IDAHO CODE §§ 5-330, 39-1391c, 39-7703, 46-1017 (modifying liability rules for emergency medical aid); OR. REV. STAT. §§ 30.800, 30.805, 676.340,
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 195 the greatest liability.287 This includes private physicians who continue to perform their normal tasks under public health emergency conditions.288 Private hospitals and clinics are also frequently omitted from immunity exemptions regardless of whether they charge for their assistance.289 Nevertheless, these private healthcare institutions and their staff will likely shoulder the majority of the work in a public health emergency.290 In some jurisdictions, these private healthcare institutions and their staff might have immunity but this protection is much narrower than that provided to other responders.291 As a result, private healthcare workers might be declared responsible for an assortment of activities that are expected during a public health emergency.292 For example, liability could attach regarding triage decisions, decisions on how to ration ventilators, for providing negligent medical care or for providing medical without the proper license.293 Private healthcare institutions are cognizant of these risks, signaling that potential litigation may chill their desire to help during public health emergencies.294
3. Ventilator Safety
For the last several decades, mechanical ventilation has been used as common tool for life support.295 However, there are various complications that have arisen with mechanical ventilation under normal circumstances, and these issues will only be exacerbated during a health crisis.296 Ventilators are complex machines that necessitate proper training to guarantee proper outcomes.297 Some common issues that cause adverse patient outcomes are incorrect setting modifications, failing to adjust the alarms, altering the settings without
676.345 (modifying liability rules for emergency and volunteer medical aid); WASH. REV. CODE §§ 4.24.300, 38.56.080 (modifying liability rules for volunteer emergency medical aid). 287. Seely, supra note 278, at 877. 288. Hoffman, supra note 275, at 1953. 289. Id. 290. Id. 291. Id. 292. Id. 293. Id. 294. Id. 295. J.D. Rickard et. al., Ventilator-Induced Lung Injury, 22 EUR. RESPIR. J. 2s, 2s (2003). 296. See id. 297. Lesley Williams & Sandeep Sharma, Ventilator Safety, STATPEARLS, https://www.ncbi.nlm.nih.gov/books/NBK526044/ (last updated April 8, 2020).
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196 GONZAGA LAW REVIEW Vol. 56:1 appropriate orders, and failing to inform the hospital personnel of changes.298 For instance, these breathing machines are made with several safety features such as alarms for low oxygen pressure, insufficient volume conveyance, and interruption of service.299 These alarms only work when the machine is turned on.300 Ventilator failure can occur because the power supply is interrupted causing the battery to be drained, insufficient battery backup, undetected power supply failure, or a short circuit due to a power surge.301 Other safety issues arise because people with insufficient training in ventilators change the settings.302 These dangers require that “every patient on ventilat[ion] must have a bag valve and mask” available near them that is checked daily to make sure it is in good repair and working.303 This bag valve is needed to manually provide oxygen to the patient when the alarm on the machine sounds, if the person self-extubates, and when the patient is receiving insufficient oxygenation or effective ventilation.304
4. Court Cases Dealing with Ventilators
A plethora of lawsuits involving ventilators have arisen in a variety of contexts. In Nguyen v. IHC Medical Services, Inc., a child was severely hurt in a car accident and hospitalized in the pediatric intensive care unit with lung and brain injuries.305 To assess the minor’s injuries, a CT scan of the brain was ordered, which required transporting the child to another floor.306 “[A] high- powered ventilator was required to maintain his cardiac function during” the trip.307 The hospital had a portable sales demo ventilator available.308 The hospital’s protocol for testing and using demo ventilators provided that they could only be utilized on moderately ill and stable children.309 The patient’s condition was so critical that he could not survive an interruption in ventilation.
298. Id. 299. Krishna Kumar et. al., Ventilator Malfunction, 27 J ANAESTHESIOLOGY CLINICAL PHARM. 576, 576 (2011). 300. Id. 301. Id. 302. Williams & Sharma, supra note 297. 303. Id. 304. Id. 305. Nguyen v. IHC Med. Servs., Inc., 2012 UT App 288, ¶ 2, 288 P.3d 1084, 1086– 87. 306. Id. at 1087. 307. Id. 308. Id. 309. Id.
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Although the child was connected to the demo ventilator for about an hour without issue, the device suddenly lost power and stopped working when transporting the child between floors.310 A short circuit occurred when a screw touched the motherboard.311 The patient died a short time later.312 The plaintiffs asserted that the hospital owed an independent legal duty to the child, separate from the treating physician, to obtain the parent’s informed consent before using the test ventilator.313 The lower court granted the defendant’s motion for summary judgment, and the plaintiffs appealed.314 The Utah Court of Appeals noted that the obligation to obtain informed consent usually rests with the treating physician in the absence of special circumstances.315 In this case, the hospital was “integrally involved” with the demo ventilator’s use, and the device was not a standard ventilator that one might use.316 When a procedure is being employed outside of the normal course, it creates a foreseeable risk of harm to others.317 When a hospital authorizes the use of a ventilator not owned by the facility and that is largely unfamiliar to them, an independent duty is imposed upon the hospital to obtain informed consent.318 Unfamiliar equipment on the hospital’s premises places them in a comparable position with the physician to inform of the potential dangers.319 Therefore, the defendant had an independent duty to obtain the parent’s informed consent.320 The issue of a defective ventilator was considered in Redfield v. Beverly Health and Rehabilitation Services, Inc.321 The plaintiff was a “ventilator dependent quadriplegic who lived in a nursing home.”322 On the morning in question, an employee checked the ventilator circuit, and it was operating
310. Id. 311. Id. at 1087–88. 312. Id. at 1087. 313. Id. at 1088. This case has a convoluted history and had been appealed once before. See Nguyen v. IHC Med. Servs., Inc., 2010 UT APP 85, 232 P.3d 529. 314. Nguyen, 288 P.3d at 1088. 315. Id. at 1089. 316. Id. at 1090. 317. Id. at 1091. 318. Id. at 1090–92. 319. Id. at 1092. 320. Id. 321. Redfield v. Beverly Heath & Rehab. Servs., Inc., 42 S.W.3d 703, 703 (Mo. Ct. App. 2001), overruled on other grounds by Sides v. St. Anthony’s Med. Ctr., 258 S.W.3d 811 (Mo. 2008); see also Turtle Healthcare Group v. Linan, 338 S.W.3d 1 (Tex. App. 2009) (addressing negligence claim against pharmacy for providing an improperly charged and defective ventilator). 322. Redfield, 42 S.W.3d at 707.
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198 GONZAGA LAW REVIEW Vol. 56:1 properly.323 About one hour later, another nurse found the patient cold and unresponsive. Upon closer examination, the patient’s supplemental oxygen tube was discovered disconnected on the floor, and his ventilator had been unplugged for forty-five minutes.324 The patient was transported to the hospital, but he had no brain activity and died.325 A suit was filed against the designer of the ventilator as well as the nursing home. A $2 million verdict was rendered, but the court granted a new trial. An appeal followed.326 A review of the record demonstrated that there was sufficient evidence to establish that the ventilator was defective and unreasonably dangerous.327 Expert testimony showed that the device was susceptible to failure because of the age of the technology inside the ventilator.328 The expert witness also stated that the “absence of a redundant backup breathing system . . . [and] the absence of an independent redundant alarming system made the unit unreasonably dangerous.”329 The testimony showed that the ventilator was not working when the patient was discovered unresponsive and not breathing and that the alarm failed to sound when the machine stopped working.330 Therefore, the court agreed that there was sufficient evidence to demonstrate that the ventilator was defective and that the condition caused the patient’s death.331 The provisions of the Emergency Medical Treatment and Active Labor Act (EMTALA) and Americans with Disabilities Act (ADA) were the subject of a ventilator case In the Matter of Baby K.332 This tragic matter involved a baby born with anencephaly, “a congenital defect in which the brain stem is present but the cerebral cortex is absent.”333 There is no cure for the malady; the infant is permanently unconscious and cannot hear or see, and death is usually inevitable within days of birth.334 Because the infant was having difficulty breathing, she was placed on a ventilator. Soon after her birth, the physicians asked the mother to allow a “Do Not Resuscitate” order to be implemented so that they could discontinue ventilation treatment because ongoing medical care
323. Id. 324. Id. 325. Id. 326. Id. 327. Id. at 710. 328. Id. 329. Id. 330. Id. at 710–11. 331. Id. 332. In the Matter of Baby K., 832 F. Supp. 1022, 1026 (E.D. Va. 1993). 333. Id. at 1025. 334. Id.
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 199 was futile.335 The mother refused because she believed that God would work a miracle to save the child if that was his will.336 The hospital filed a declaratory judgment requesting the court to declare that discontinuance of ventilator treatment to the baby would not violate the EMTALA and ADA.337 The baby was transferred to a nursing home but was repeatedly brought back to the emergency room for ventilation.338 The court ultimately denied the hospital’s request.339 The EMTALA requires a hospital to stabilize a person who enters the emergency room with an emergency medical condition such as a breathing problem.340 In that event, the use of a ventilator is required to guarantee that the patient’s condition does not deteriorate.341 The statute does not contain any exceptions for when the stabilization is futile or inhumane.342 Such an exclusion can only be implemented by Congress.343 As for the ADA, its plain language does not allow medical workers to deny mechanical ventilation for an anencephalic baby when those same services must be offered to a baby without a disability.344
5. Court Cases Dealing with COVID-19
There will be any number of lawsuits filed over the coronavirus, ranging from personal injuries claims against entities such as cruise ships, day care centers, and nursing homes alleging that they did not take adequate steps to protect their patrons to lawsuits against employers for worker’s compensation and disability benefits.345 For instance, the pilots’ union at American Airlines has filed lawsuits against the carrier to prevent it from flying to China, and a city in California sued the federal government to prevent cruise passengers from disembarking to a state-owned facility at its port.346 A class action lawsuit has been filed against Amazon claiming that the online company is charging “grossly
335. Id. 336. Id. at 1026. 337. Id. 338. Id. at 1025. 339. See id. at 1031. 340. Id. at 1026. 341. Id. at 1026–27. 342. Id. at 1027. 343. Id. 344. Id. at 1028–29. 345. Bob Van Voris et. al., Lawsuits Against Businesses Over Coronavirus Have Begun. More to Come?, INS. J. (Mar. 4, 2020), https://amp.insurancejournal.com/news /international/2020/03/04/560140.htm. 346. Id.
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200 GONZAGA LAW REVIEW Vol. 56:1 unconscionable” prices for toilet paper and hand sanitizer.347 Another class action lawsuit is pending against Inovio Pharmaceuticals over claims that the firm deceived investors and the community about the development of a coronavirus vaccine.348 Even Jim Bakker, a televangelist, has been sued by the state of Missouri for violating the Missouri Merchandising Practices Act for his actions in selling an alleged coronavirus cure on his show and website.349 Claims challenging government-imposed quarantines because of COVID-19 and the limitations on public gatherings are not likely to be successful. The government has inherent broad powers to implement rules in the face of a public health crisis, and the states enjoy sweeping police powers to protect members of society.350 Therefore, these types of lawsuits will have a limited chance of success unless they demonstrate “a truly egregious practice.”351 A number of matters have ended up before the United States Supreme Court, but the Court has been reluctant to accept these cases. For instance, the Court denied the South Bay Pentecostal Church’s application for injunctive relief against California’s reopening guidelines that limited the number of people who could attend religious services.352 The Church claimed that the restrictions on their face were a “blatant violation” of the First Amendment.353 Likewise, the Court denied injunctive relief in a case brought by a religious institution in Nevada challenging a policy restricting in-person church attendance to fifty people.354 The justices also refused to block a federal judge’s order directing federal prison officials to expeditiously move inmates due to COVID-19
347. Bridgette Honaker, Amazon Class Action Alleges Coronavirus Prices Gouging, TOP CLASS ACTIONS (Mar. 13, 2020), https://topclassactions.com/lawsuit-settlements /coronavirus/a-complete-guide-to-the-coronavirus-outbreak-legal-issues/. 348. Stephen Cohen, Inovio Sued Over False Coronavirus Vaccine Claims, TOP CLASS ACTIONS (Mar. 19, 2020), https://topclassactions.com/coronavirus-covid-19/inovio-sued -over-false-coronavirus-vaccine-claims/. 349. Christina Davis, Televangelist Bakker Faces Lawsuit After Selling Fake ‘Coronavirus Cure,’ TOP CLASS ACTIONS (Mar. 16, 2020), https://topclassactions.com /coronavirus-covid-19/televangelist-jim-bakker-faces-lawsuit-after-selling-fake-coronavirus- cure/. 350. See Deborah Weiss, Lawsuits over Coronavirus Quarantines Are Unlikely to Succeed, Experts Say, ABA J. (Mar. 18, 2020), https://www.abajournal.com/news/article /suits-over-coronavirus-quarantines-unlikely-to-succeed-experts-say. 351. Id. 352. See S. Bay United Pentecostal Church v. Newsom, 140 S. Ct. 1613, 1613 (2020). 353. Rebecca Klar, California Church Going to Supreme Court over In-Person Restrictions, THE HILL (May 26, 2020), https://thehill.com/regulation/court-battles/499484 -california-church-going-to-supreme-court-on-in-person-restrictions. 354. Calvary Chapel Dayton Valley v. Steve Sisolak, 140 S.Ct. 2603, 2603 (2020).
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2020/21 COVID-19: ETHICAL & LEGAL IMPLICATIONS 201 outbreak at the Elkton Federal Correctional Institution in Ohio.355 However, the Court granted Alabama’s request to temporarily block a federal district court order that would have eased voting restrictions for absentee ballots due to COVID-19. This kept a mandate in place that required voters to provide an affidavit signed by a notary or two adult witnesses with absentee ballots.356 The Court also refused to provide relief to the spiritual advisors of two inmates who faced federal executions.357 No one knows if these decisions were based upon ideology, precedent, or process, but the Court has appeared to these authors to show a hesitancy to second-guess lower courts and government officials in the pandemic. Most lower court decisions deal with individuals in detention seeking release because of their fear of being infected with the coronavirus. Costillo v. Barr is noteworthy because the court discussed COVID at length.358 This suit for a temporary restraining order was filed by two men with various medical conditions who were detained at the Adelanto Detention Center in California.359 The plaintiffs were arrested by officers from the United States Department of Homeland Security and placed into removal proceedings for being an alien present in the United States without being admitted or paroled.360 They sought their release on the basis that they could be exposed to COVID-19 during detention through person-to-person contact.361 The court noted:
COVID-19 is highly contagious and has a mortality rate ten times greater than influenza. Most troublesome is the fact that people infected with the coronavirus can be asymptomatic during the two to fourteen
355. Robert Barnes, Supreme Court Won’t Stop Ohio Order for Prisoners to Be Moved or Released Because of Coronavirus, WASH. POST (May 26, 2020), https://www .washingtonpost.com/politics/courts_law/supreme-court-for-now-will-not-stop-ohio-order -to-identify-prisoners-for-release-because-of-coronavirus/2020/05/26/8b6d458a-9f74-11ea -81bb-c2f70f01034b_story.html. 356. David Welna, Supreme Court Temporarily Blocks Easier Voting by Mail in Alabama During Coronavirus, NPR (July 3, 2020), https://www.npr.org/2020/07/03 /887113506/supreme-court-temporarily-blocks-easier-voting-by-mail-in-alabama-during -coronav. 357. Richard Wolf, Pandemic Lawsuits from Voters Worshipers Prisoners Meet Roadblock at Supreme Court, USA (July 22, 2020, 11:36 AM), https://www.usatoday.com /story/news/politics/2020/07/22/pandemic-lawsuits-voting-prayer-prison-face-supreme-court -barrier/5473024002/. 358. Castillo v. Barr, 449 F. Supp. 3d 915, 918–20 (C.D. Cal. 2020). 359. Id. at 917. 360. Id. 361. Id. at 920.
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day COVID-19 incubation period. During that asymptomatic incubation period, infected people are, unknowingly, capable of spreading the coronavirus. Despite early reports, no age group is safe from COVID- 19. While older people with pre-existing conditions are the most vulnerable to COVID-19-related mortality, young people without preexisting conditions have, also, succumbed to COVID-19. There is no specific treatment, vaccine or cure for COVID-19.362
The court was particularly concerned because of the contagious character of the illness along with its mortality rate.363 The virus can move about irrepressibly with destructive consequences in a packed immigration detention center where a holding area can house sixty to seventy people and neither masks nor hand sanitizers are available to the detainees.364 The court agreed with the plaintiff’s constitutional arguments and opined that when the government detains a person, the Due Process Clause requires the government to undertake the responsibility for that person’s safety and general wellbeing.365 The court also noted that the government violates the Eighth Amendment when it detains a person in unsafe conditions as the government cannot “ignore a condition of confinement that is sure or very likely to cause serious illness.”366 The Ninth Circuit Court of Appeals, in Xochihua-Jaimes v. Barr, granted a detainee’s release: “In light of the rapidly escalating public health crisis, which public health authorities predict will especially impact immigration detention centers, the court . . . orders that Petitioner be immediately released from detention and that removal of Petitioner be stayed pending final disposition by this court.”367 In United States v. Ramos, the defendant was arrested for distributing cocaine.368 The defendant “filed an emergency motion for release from custody pending trial” because his diabetes and asthma put him at risk for complications if he were to contract COVID-19 while detained.369 The court agreed and noted that the CDC has reported that those with “moderate to severe asthma and diabetes ‘may be at higher risk of getting very sick from COVID-19.’”370
362. Id. at 918. 363. Id. 364. Id. at 918–19. 365. Id. at 920. 366. Id. (quoting Helling v. McKinney, 509 U.S. 25, 32 (1993)). 367. Xochihua-Jaimes v. Barr, 798 F.3d 1065, 1066 (9th Cir. 2020). 368. United States v. Ramos, 450 F. Supp. 3d 63, 64 (D. Mass. 2020). 369. Id. 370. Id.
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Accordingly, the most effective method to protect susceptible people is to limit their exposure to the virus.371 The opposite result was reached by a federal court in Texas. In Sacal-Micha v. Longoria, the petitioner sought his release from an immigration detention center because he alleged the facility was unable to protect him from the coronavirus.372 Sacal is a 69-year-old, wealthy, Mexican citizen with serious medical conditions. He was accused of committing a violent offense against his granddaughter in Mexico, and a warrant was issued for his arrest. He fled to the United States but was arrested upon his entry into the country.373 In his petition, he asserted that that “‘Respondents cannot prevent the Covid-19 virus from infecting’ the detention center where he is detained” and “that the Constitution requires the Respondents to provide ‘other safe conditions of confinement’” which the government cannot do.374 In denying his request, the court opined that a detainee can only prove a “constitutional violation based on inadequate conditions of his confinement.”375 This mandates a showing that the officials acted with deliberate indifference to his medical needs or his safety.376 In this case, the evidence revealed that ICE offered him constant medical care and executed preventative safeguards to reduce his risk of contracting COVID-19.377 Likewise, a federal district court in Washington denied a request by detainees for a temporary restraining order. In Dawson v. Asher, the petitioners requested to be released from detention as they awaited a determination of their immigration cases, claiming that the facility where they were detained made them “particularly vulnerable to serious illness or death if infected by COVID- 19” because of their age and medical conditions.378 The court denied the request because the facility had implemented safeguards and safety protocols to reduce the risk of exposures to the coronavirus.379 When considering a Fifth Amendment claim, the court must determine if the civil detention “amount[s] to punishment of the detainee.”380 No evidence was presented to show that the facility engaged
371. Id. 372. Sacal-Micha v. Longoria, 449 F. Supp. 3d 656, 660 (S.D. Tex. 2020). 373. Id. at 660–61. 374. Id. at 663 (emphasis in original). 375. Id. at 664. 376. Id. 377. Id. 378. Dawson v. Asher, No. C20-0409JLR-MAT, 2020 WL 1704324, at *1 (W.D. Wash. 2020). 379. Id. at *11–12. 380. Id. at *10.
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204 GONZAGA LAW REVIEW Vol. 56:1 in conduct that showed an “express intent” to punish the detainees.381 At the time of the hearing, there was no evidence that anyone at the facility had been infected with the virus, and the facility was taking steps to prevent an outbreak of COVID- 19.382
IV. CONCLUSION
Pandemics are not unique to modern society. “Influenza pandemics have been a regular occurrence throughout human history.”383 A major change from past pandemics is that today scientists can develop vaccines and antiviral medications, and use technology like ventilators to help those who are ill in a pandemic.384 While these advances in medical science “should provide significant benefits to many people” during a pandemic, warning signs foreshadowed a stark reality whereby a critical shortage of supplies, such as ventilators, hospital beds, masks, and other protective gear, may arise.385 SARS- CoV-2 has succeeded in fulfilling these dire prophecies. The coronavirus pandemic presents many thorny legal and ethical issues. This is not surprising since whenever there is “an adverse health outcome because of the need to ration healthcare services or the need for healthcare providers to work outside of their normal professional responsibilit[ies], healthcare personnel and organizations may be subject to professional liability lawsuits or other legal challenges.”386 It will take years and many court battles to sort through these issues. Whether courts will adopt an altered standard of care to cover the emergency decisions made by health care providers in rationing supplies in short supply remains to be seen. What is known is that the coronavirus is a lethal illness that is wrecking the economy and altering the course of history.
381. Id. 382. See id. at *5. 383. Carl H. Coleman, Allocating Vaccines and Antiviral Medications During an Influenza Pandemic, 39 SETON HALL L. REV. 1111, 1111 (2009). 384. See id. 385. Id.; see discussion supra Section II.A. 386. Patrone & Resnick, supra note 144, at 173.