Principles of Legal Triage 2009 H1N1 (Swine) Flu and Principles of Legal Triage James G. Hodge, Jr., J.D., LL.M. Lincoln Professor of Health Law and Ethics Director, Public Health Law and Policy Program Sandra Day O’Connor College of Law Arizona State University

Principal Objectives Brief Update on 2009 H1N1 Flu International and National Responses Legal Environment Concerning Declarations of Public Health Emergencies Principles of Legal Triage Legal Triage re: Global Health Issues Concerning 2009 H1N1 Flu

Brief Disclaimer Information in this presentation is current through September 29, 2009, unless indicated otherwise As additional facts develop related to the spread of H1N1 influenza or legal responses, analyses presented herein will change as well 3 3

2009 H1N1 Flu Epidemiology Contagious respiratory disease that commonly originates from pigs and is caused by a type-A influenza The current strain is a new variation of an H1N1 virus, which includes a mix of human and animal versions, and thus defined as “novel” This strain is particularly dangerous because it can spread from human to human instead of from animals to humans H1N1 may continue to mutate, making it more difficult to treat and combat due to potential lack of immunity 4 4

2009 H1N1 Flu Epidemiology Symptoms of H1N1 are similar to the common flu: Fever Lethargy, Lack of appetite, Coughing, runny nose, sore throat Occasional nausea, vomiting, diarrhea H1N1 is more easily transmitted than common flu but through the same typical routes 5 5

2009 H1N1 Flu Epidemiology This “novel” strain of H1N1 was first detected in Mexico City, where surveillance began picking up a surge in cases of influenza-like illness on March 18, 2009 The first H1N1 flu death (39 year old female) occurred on April 13 in Mexico Mexican authorities initially assumed this surge to be a “late-season flu” until April 21 when a CDC alert regarding two isolated cases was reported 6 6

WHO Pandemic Influenza Phases Current Pandemic Influenza Phase (as of September 29, 2009): Phase 6 7 7

WHO Pandemic Influenza Phases World Health Organization Pandemic Influenza Phases (2009) Pandemic Influenza Phase Characterization of Phase Public Health Goals Phase 3 Human infection(s) with a new subtype, but no human-to-human spread, or at most rare instances of spread to a close contact Ensure rapid characterization of the new virus subtype and early detection, notification and response to additional cases Phase 4 Small cluster(s) with limited human-to-human transmission but spread is highly localized, suggesting that the virus is not well adapted to human Contain the new virus within limited foci or delay spread to gain time to implement preparedness measures, including vaccine development Phase 5 Larger cluster(s) but human-to-human spread still localized, suggesting that the virus is becoming increasingly better adapted to humans, but may not yet be fully transmissible (substantial pandemic risk) Maximize efforts to contain or delay spread, to possibly avert a pandemic, and to gain time to implement pandemic response measures Phase 6 Pandemic increased and sustained transmission in general population Minimize the impact of the pandemic

2009 H1N1 Flu: U.S. Response April 27, 2009 - President Barack Obama: “We are closely monitoring the emerging cases of swine flu in the United States. And this is obviously a cause for concern and requires a heightened state of alert.  But it's not a cause for alarm.” National Academy of Sciences Speech: April 27, 2009

2009 H1N1 Flu: U.S. Response September 1, 2009- President Barack Obama: “[A]s I said when we saw the first cases of this virus back in the spring, I don't want anybody to be alarmed, but I do want everybody to be prepared. We know that we usually get a second, larger wave of these flu viruses in the fall, and so response plans have been put in place across all levels of government. “[O]ur plans and decisions are based on the best scientific information available, and as the situation changes, we will continue to update the public..." Rose Garden, White House, Washington, D.C. Remarks by the President on 2009-H1N1 Preparedness and Response 10 10

2009 H1N1 Flu: U.S. Response September 15, 2009- DHHS Secretary Kathleen Sebelius “Well, the fear is that, until we get the vaccine and until people have immunity, we could have a lot of illness. So, we have to take steps right now to really prepare for that for possible hospital surge, looking at additional capacity, but doing everything we can to mitigate the transmission [~] keeping sick children home, keeping sick adults home, . . . that's the strategy we have to put in place in a widespread fashion until we get enough vaccine that people really can be fully immunized against the spread of the flu." Voices of Power: Secretary of Health and Human Services, Kathleen Sebelius Worldwide Reporting LLP 11 11

2009 H1N1 Flu – CDC Briefing Most of the illness . . . appears to be moderate or moderately severe.  And that's good news, but it's not always the case, and it could change, and that's why we want to monitor the virus. . . . Dr. Daniel Jernigan, Deputy Director, CDC Influenza Division (Sept 18, 2009) “[T]he good news is we have a vaccine. It's likely to be highly effective after a single dose for people age [10+] . . . [I]t's going to be rolling off the production lines, . . . into warehouses and . . . to doctors' offices, clinics, health departments and school[s] . . . .” Dr. Thomas Frieden (CDC Director) (Sept 25, 2009) 12 12

WHO Confirmed Cases: 2009 H1N1 Flu 13 13 13

2009 H1N1 Flu Case Updates– September 29, 2009 Mexico: 27,085 laboratory confirmed human cases of infection, including 220 deaths (Source: PAHO) United States: 43,771 laboratory confirmed human cases, including 593 deaths (Source: PAHO) Source: PAHO (September 29, 2009): http://new.paho.org/hq/images/stories/AD/HSD/CD/Epidemic_Alert_and_Response/MAPS/week37/eng/map1.jpg 14 14

2009 H1N1 Flu – U.S. Cases CDC. Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary, 2008-09 Source: CDC Influenza Situation Update --September 29, 2009 http://www.cdc.gov/flu/weekly/ 15 15

U.S. Cases of 2009 H1N1 Flu – May 7 HI AK Legend 16 No confirmed cases Last Updated: May 7, 2009 Source: CDC http://www.cdc.gov/h1n1flu/ 16

U.S. Cases of 2009 H1N1 Flu – May 27 HI AK Legend No confirmed cases Last Updated: May 27, 2009 Source: CDC http://www.cdc.gov/h1n1flu/

U.S. Cases of 2009 H1N1 Flu – June 17 HI AK Legend No confirmed cases Last Updated: June 17, 2009 Source: CDC http://www.cdc.gov/h1n1flu/

U.S. Cases of 2009 H1N1 Flu – Sep 29 HI AK Legend No confirmed cases Last Updated: September 29, 2009 Source: PAHO http://new.paho.org/hq/images/atlas/en/atlas.html >50 confirmed cases

U.S. Cases of 2009 H1N1 Flu – Sep 29 HI AK Legend 1– 45 confirmed cases 45-100 confirmed cases 101- 500 confirmed cases 501-1000 confirmed cases 1001-5000 confirmed cases Last Updated: September 29, 2009 Source: PAHO http://new.paho.org/hq/images/atlas/en/atlas.html 5001+ confirmed cases

Public Health Law in Real Time Legal Triage

Assessing the Role of Law in Emergencies Laws pervade emergency responses at every level of government: They determine what constitutes a public health or other emergency They help create the infrastructure through which emergencies are detected, prevented, and addressed They authorize the performance (or nonperformance) of various emergency responses by a host of actors They determine the extent of responsibility for potential or actual harms that arise during emergencies

Assessing the Legal Environment in Emergencies

The Convergence of Governments During Major Emergencies

The Convergence of Partners During Major Emergencies

The Convergence of Actors During Major Emergencies

Legal Triage Legal Triage in PHEs – Public health law in real-time

Legal Triage Legal triage refers to the efforts of legal actors and others to construct a favorable legal environment during emergencies through a prioritization of issues and solutions that facilitate legitimate public health responses Hodge, JG, Anderson, ED. Principles and practice of legal triage during public health emergencies. NYU Ann. Surv. Am. L. 2008; 64(2): 249-291.

Legal Triage Legal actors and others must be prepared to: assess and monitor changing legal norms during emergencies; identify legal issues that may facilitate or impede public health responses as they arise; develop innovative, responsive legal solutions to reported barriers to public health responses; explain legal conclusions through tailored communications to planners and affected persons; and consistently revisit the utility, efficacy, and ethicality of legal guidance.

State of Emergency Once an emergency has been declared, the legal landscape changes.

Emergency Declarations How the legal landscape changes depends on the type of emergency declared

Multiple Levels of Emergency Declarations International Federal Emergency Declarations By Intl Govs WHO PHEIC “HHS” Public Health Emergency State “FEMA” Emergency Local Emergency or Disaster Public Health Emergency Emergency or Disaster Public Health Emergency

Multiple Levels of Emergency Declarations International Govts Emergency Declarations International W.H.O. Public Health Emergency of International Concern (PHEIC) Federal “DHHS” public health emergency Federal “FEMA” emergency State public health emergency State emergency or disaster Local public health emergency Local emergency or disaster Public health authorities and powers, actors, liabilities, immunities, and other critical legal issues vary depending on the declared emergency

2009 H1N1 Flu: International Declarations April 25, 2009: WHO Director General, Dr. Margaret Chan, declares first-ever public health emergency of international concern pursuant to the International Health Regulations (2007) 34 34 34

International Health Regulations (IHRs) (2007)* Determination of a PHEIC Following announcement of PHEIC, WHO recommends that nations increase their active surveillance for unusual outbreaks of influenza-like illness Ongoing Communication WHO maintains constant contact with the National IHR Focal Points PAHO coordinates communications between the U.S., Mexico, and Canada National IHR Focal Points globally supply daily reports of confirmed and suspected cases to WHO WHO communicates with all member states through the National IHR Focal Points and online and shares recommendations for action * Katz R. Use of revised international health regulations during influenza A (H1N1) epidemic. Emerg Infect Dis. 2009 Aug; [Epub ahead of print] 35

2009 H1N1 Flu: National Declarations April 26, 2009: U.S. DHHS Acting Secretary, Charles Johnson, declares a public health emergency Via the Public Health Service Act, 42 U.S.C. § 247d Allows federal, state, and local agencies to utilize federal resources to prevent and mitigate H1N1 flu Renewed by DHHS Secretary Kathleen Sebelius on July 24, 2009 [for an additional 90 days] 36 36 36

Emergency Declarations - State Approaches Before 9/11: Existing state legal infrastructures focused on general emergency or disaster responses “All hazards” approach After 9/11: Reforms of emergency laws in many states are reformed to address “public health emergencies” Based in part on the Model State Emergency Health Powers Act (MSEHPA) 37 37

States That Define “Emergency” HI WA VT NH AK MT ME ND MN OR ID MA SD WI NY MI WY RI CT NE IA PA NJ NV IN OH DE IL CA UT MD CO WV KS MO VA DC KY NC TN AZ OK NM AR SC MS AL GA TX LA FL “Emergency” or similar term defined in state statutes - 39 PR - (Puerto Rico) VI - (U.S. Virgin Islands) Data Current as of April 1, 2008

“Emergency” Defined - Florida “Emergency" is defined as “any occurrence, or threat thereof, whether natural, technological, or manmade, in war or in peace, which results or may result in substantial injury or harm to the population or substantial damage to or loss of property.” F.S.A. § 252.34(3) (2005).  

States That Define “Disaster” HI WA VT NH AK MT ME ND MN OR ID MA SD WI NY MI WY RI CT NE IA PA NJ NV IN OH DE IL CA UT MD CO WV KS MO VA DC KY NC TN AZ OK NM AR SC MS AL GA TX LA FL “Disaster” or similar term defined in state statutes - 42 PR - (Puerto Rico) VI - (U.S. Virgin Islands) Data Current as of April 1, 2008

“Disaster” Defined - Texas "Disaster" means the occurrence or imminent threat of widespread or severe damage, injury, or loss of life or property resulting from a natural or man-made cause, including fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, volcanic activity, epidemic, air contamination, blight, drought, infestation, explosion, riot, hostile military or paramilitary action, other public calamity requiring emergency action, or energy emergency. Tex. Gov’t Code Ann. § 418.004(1), (3) (Vernon 2003)

States That Define “Public Health Emergency” HI WA VT NH AK MT ME ND MN OR ID MA SD WI NY MI WY RI CT NE IA PA NJ NV IN OH DE IL CA UT MD CO WV KS MO VA DC KY NC TN AZ OK NM AR SC MS AL GA TX LA FL “Public health emergency” or similar term defined in state statutes - 26 PR - (Puerto Rico) VI - (U.S. Virgin Islands) Data Current as of April 1, 2008

“Public Health Emergency” Defined - MSEHPA An occurrence or imminent threat of an illness or health condition that (1) is believed to be caused by any of the following: Bioterrorism Appearance of a novel or previously controlled or eradicated infectious agent or biological toxin Natural disaster Chemical attack or accidental release Nuclear attack or accident; and

“Public Health Emergency” Defined - MSEHPA (2) poses a high probability of any of the following harms occurring in a large number of the affected population: Death Serious or long-term disability Widespread exposure to infectious or toxic agent posing significant risk of substantial future harm

“Public Health Emergency” Defined - Arizona “A state of emergency or state of war emergency declared by the governor in which there is an occurrence or imminent threat of an illness or health condition caused by bioterrorism, an epidemic or pandemic disease or a highly fatal infectious agent or biological toxin and that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability.” Ariz. Rev. Stat. § 36-787 (2006) 45 45

Emergency Powers - MSEHPA Individuals are bestowed special protections and entitlements Government is vested with specific, expedited powers to facilitate emergency responses Hospital privileging requirements may be waived Volunteer responders may be protected from civil liability

States That Define “Public Health Emergency” and “Emergency” or “Disaster” HI WA VT NH AK MT ME ND MN OR ID MA SD WI NY MI WY RI CT NE IA PA NJ NV IN OH DE IL CA UT MD CO WV KS MO VA DC KY NC TN AZ OK NM AR SC MS AL GA TX LA “Emergency”, “disaster”, and “public health emergency” (or similar terms) defined in state Statutes - 27 FL PR - (Puerto Rico) VI - (U.S. Virgin Islands) Data Current as of April 1, 2008

Dilemmas of Dual (or Duel) Declarations Triggering of distinct powers and responsibilities under each declaration Assignments of powers to different governmental agencies (e.g., public health agency vs. emergency management agency) lead to overlapping priorities Widely divergent responses and decisions on key issues Compounded in national emergencies when federal, state, and local authorities seek to respond to their specifically-declared emergencies

Dilemmas of Dual (or Duel) Declarations: Maryland Assignment of Powers in Maryland: Emergency: Maryland Department of Emergency Management Public Health Emergency: Maryland Department of Health and Mental Hygiene

Emergency, Disaster, and Public Health Declarations in Response to H1N1 HI AK Sonoma County Alameda County San Francisco San Mateo County San Bernardino County Ventura County Los Angeles County LEGEND Federal DHHS Public Health Emergency Declaration Emergency Declaration American Samoa (U.S. Territory) Disaster Declaration Public Health Emergency Declaration Emergency and Public Health Emergency Declarations Localities Declaring Emergencies/Disasters/Public Health Emergencies Last Updated: June 17, 2009

*WHO PHEIC Declared April 24, 2009 State H1N1 Emergency Declarations Timeline Ongoing Emergency Declaration *WHO PHEIC Declared April 24, 2009

Legal Triage Challenges: 2009 H1N1 Flu Quarantine Powers Hong Kong, China Quarantine of 71 Mexican nationals International Travel Restrictions Restricted travel to Mexico and U.S. 3. Allocation of Available Antivirals 4. International Trade Restrictions Restricted trade of pork products with Mexico, U.S., and Canada 52 52

International Quarantine Powers Hong Kong: isolation of 71 Mexicans Mexican Foreign Minister Patricia Espinosa: “countrymen placed under quarantine despite showing no signs of swine flu”… and having no contact with those infected Mexico’s President Felipe Calderón: “countries acting out of ignorance and disinformation” and taking “repressive, discriminatory measures.” "The task we have carried out was intended purely for the safety of the public and our city.”- Liang Banmiam, Chinese Health Bureau Spokesman 53 53

International Travel Restrictions Argentina, Peru, Ecuador, and Cuba suspended flights to Mexico China suspended flights from Mexico to Shanghai and Xinhua UN Secretary-General Ban Ki-moon: asked governments to reverse trade and travel restrictions unless they have a clear scientific basis for doing so “[S]uch restrictions are unlikely to prevent the spread of the disease while disrupting the functioning of the world community.” – David Navarro, Senior UN Coordinator for Influenza 54 54

Allocation of Available Antivirals WHO DG Dr. Margaret Chan called for more donations of antiviral drugs to global stock More antivirals are needed to prepare a global response to the spread of H1N1 now and in the future Pharmaceutical companies may be willing to donate over possibility of outsourcing products Relenza: GlaxoSmithKline, England Tamiflu: Roche AG, Switzerland President Obama pledges 10% of U.S. vaccine supplies for global effort 55 55

International Trade Restrictions Ban of live pig and pork imports Russia, China, and Ecuador: banned pork products from Mexico and U.S. WTO SPS Agreement: allows countries to suspend imports of food for health and safety reasons WTO: No justification for the imposition of trade restrictions on account of 2009 H1N1 Flu U.S. Meat Export Federation: recent bans have cut U.S. pork exports 8-10% 56 56

The Continuing Challenge of Legal Triage The question is not whether to engage in legal triage during declared emergencies . . . , but how?

Features of Emergency Laws & Policies Flexibility in response Quickness in decision making Suspension of existing legal norms Coordination of services Access to resources Limitations of restrictions Balancing individual/communal interests

Drawbacks of Emergency Laws & Policies Uncertainty Inconsistency Political favoritism Non-accountability Non-transparency Potential for abuses Diminished capacity

Guiding Principles Mission to protect the public’s health at the intra- and inter-jurisdictional levels Scientifically-validated public health practices during emergencies Principles of governance that reflect actual societal responses during emergencies Ethical rules complementing legal responses Constitutional norms that are appropriate and consistent

Guiding Principles Constitutional norms - prevalent question that requires resolution: May public health authorities compel testing, screening, vaccination, treatment, or other invasive measures concerning autonomous, competent individuals?

Mandatory Influenza Vaccination NY Department of Health Regulations: Health Care Personnel Influenza Vaccination Requirements (August 13, 2009) “[r]equire that personnel be immunized against influenza virus(es) as a precondition to employment and on an annual basis…” Significant issues of autonomy inherent in principles of liberty Contrast with the duty of states to protect the public’s health in response to known communicable disease threats 62 62 James G. Hodge, Jr. & Lawrence O. Gostin, School Vaccination Requirements: Historical, Social, and Legal Perspectives, 90 Ky. L. J. 831, 867 (2001). 62

Guiding Principles Compulsory use of public health powers Acknowledge the absence of informed consent Distinguish mandatory vs. compulsory powers Distinguish autonomous adults from non- autonomous individuals Ascertain existing constitutional standards for compulsory medical interventions Assess potential public health justifications during declared emergencies

2009 H1N1 (Swine Flu) Information For updated information on swine flu, please visit: Program in Public Health Law and Policy http://www.law.asu.edu/?id=1980 Center’s H1N1 (Swine Flu) Legal Preparedness and Response: http://www.publichealthlaw.net/Projects/swinefluphl.php Special thanks to Craig Jaques, Aubrey Joy Corcoran, Brian Harel, and other Members of the Global Legal Triage Cluster Group at the Program for their research and contributions to this presentation.