1. 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

2. 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 H1N1 Flu

3. 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

4. 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

5. 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

6. 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

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

8. 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

9. 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

10. 2009 H1N1 Flu: U.S. Response
September 1, 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

11. 2009 H1N1 Flu: U.S. Response
September 15, 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

12. 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

13. WHO Confirmed Cases: 2009 H1N1 Flu13 13 13

14. 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): 14 14

15. 2009 H1N1 Flu – U.S. Cases
CDC. Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary,
Source: CDC Influenza Situation Update --September 29, 2009 15 15

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

17. U.S. Cases of 2009 H1N1 Flu – May 27 HI AK Legend No confirmed cases
Last Updated: May 27, 2009
Source: CDC

18. U.S. Cases of 2009 H1N1 Flu – June 17 HI AK Legend No confirmed cases
Last Updated: June 17, 2009
Source: CDC

19. U.S. Cases of 2009 H1N1 Flu – Sep 29 HI AK Legend No confirmed cases
Last Updated: September 29, 2009
Source: PAHO
>50 confirmed cases

20. U.S. Cases of 2009 H1N1 Flu – Sep 29 HI AK Legend
1– 45 confirmed cases
confirmed cases
confirmed cases
confirmed cases
confirmed cases
Last Updated: September 29, 2009
Source: PAHO
5001+ confirmed cases

21. Public Health Law in Real Time
Legal Triage

22. 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

23. Assessing the Legal Environment in Emergencies

24. The Convergence of Governments During Major Emergencies

25. The Convergence of Partners During Major Emergencies

26. The Convergence of Actors During Major Emergencies

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

28. 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):

29. 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.

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

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

32. 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

33. 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

34. 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

35. 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 Aug; [Epub ahead of print] 35

36. 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, 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

37. 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

38. 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

39. “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. § (3) (2005).

40. 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

41. “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. § (1), (3) (Vernon 2003)

42. 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

43. “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

44. “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

45. “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. § (2006) 45 45

46. 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

47. 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

48. 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

49. 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

50. Emergency, Disaster, and Public Health Declarations in Response to H1N1HI 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

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

52. 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

53. 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

54. 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

55. 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

56. 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

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

58. 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

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

60. 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

61. 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?

62. 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

63. 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

64. 2009 H1N1 (Swine Flu) Information
For updated information on swine flu, please visit:
Program in Public Health Law and Policy
Center’s H1N1 (Swine Flu) Legal Preparedness and Response:
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.