The 2009 Influenza Pandemic: Selected Legal Issues
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The 2009 Influenza Pandemic: Selected Legal
Issues
(name redacted), Coordinator
Legislative Attorney
(name redacted), Coordinator
Legislative Attorney
October 29, 2009
Congressional Research Service
7-....
www.crs.gov
R40560
CRS Report for Congress
Prepared for Members and Committees of Congress
The 2009 Influenza Pandemic: Selected Legal Issues
Summary
On June 11, in response to the global spread of a new strain of influenza, the World Health
Organization (WHO) raised the level of influenza pandemic alert to phase 6, which indicates the
start of an actual pandemic. This change reflected the spread of the new influenza A(H1N1) virus,
not its severity. Although currently the pandemic is of moderate severity with the majority of
patients experiencing mild symptoms and making a rapid and full recovery, this experience could
change. This report provides a brief overview of selected legal issues including emergency
measures, civil rights, liability issues, and employment issues.
There are a number of emergency measures which may help to contain or ameliorate an infectious
disease outbreak. The Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, the
National Emergencies Act, and the Stafford Act contain authorities that allow the Secretary of
Health and Human Services or the President to take certain actions during emergencies or
disasters. While the primary authority for quarantine and isolation in the United States resides at
the state level, the federal government has jurisdiction over interstate and border quarantine. The
federal government also issues recommendations regarding such activities as school closures and
vaccination programs. States and local governments have the authority to initiate emergency
measures such as mandatory vaccination orders and certain nonpharmaceutical interventions such
as school closures, which may lessen the spread of an infectious disease. The International Health
Regulations adopted by the WHO in 2005 provide a framework for international cooperation
against infectious disease threats.
The use of these emergency measures to contain the 2009 influenza pandemic may raise a classic
civil rights issue: to what extent can an individual’s liberty be curtailed to advance the common
good? The U.S. Constitution and federal civil rights laws provide for individual due process and
equal protection rights as well as a right to privacy, but these rights are balanced against the needs
of the community.
Liability issues may become particularly important during the 2009 influenza pandemic. The
Public Readiness and Emergency Preparedness Act limits liability with respect to the use of
countermeasures for pandemic flu or other public health threats. A patchwork of federal and state
laws generally protect volunteers, which may include volunteer health professionals (VHPs),
under certain circumstances. Laws also provide liability protections specifically for VHPs.
Questions relating to employment are among the most significant issues presented by an
influenza pandemic, since, if individuals fear losing their employment or their wages, compliance
with public health measures such as social distancing and isolation or quarantine may suffer. It
would seem possible for a court to conclude that the isolation or quarantine of individuals during
a pandemic serves the public good and that the termination of individuals who are isolated or
quarantined violates public policy. Employees may also have some job protection under the
Family and Medical Leave Act.
Congressional Research Service
The 2009 Influenza Pandemic: Selected Legal Issues
Contents
Introduction ................................................................................................................................1
Emergency Measures ..................................................................................................................1
Emergency Authorities ..........................................................................................................1
Public Health Emergency Authorities ..............................................................................1
National Emergencies Act Declarations ...........................................................................2
Stafford Act Declarations ................................................................................................3
Section 1135 Waivers or Modifications ...........................................................................4
Emergency Use Authorizations (for Unapproved Countermeasures) ................................6
International Health Regulations (IHR) .................................................................................7
Overview of the IHR.......................................................................................................7
Declaration of a “Public Health Emergency of International Concern”.............................8
Quarantine and Isolation Authority...................................................................................... 10
Federal Authorities........................................................................................................ 10
Federal and State Coordination...................................................................................... 11
Proposed Federal Regulations ....................................................................................... 12
Border Entry Issues ............................................................................................................ 13
Inadmissibility of Infected Aliens .................................................................................. 13
Border Quarantines of Citizens or Aliens....................................................................... 13
Closing the Border ........................................................................................................ 14
Airlines and Travel Restrictions .......................................................................................... 14
Airline Corporate Policies ............................................................................................. 14
Public Health “Do Not Board” List ............................................................................... 15
Federal Airspace Authority............................................................................................ 15
School Closures .................................................................................................................. 16
Vaccinations.............................................................................................................................. 19
Background ........................................................................................................................ 19
Allocation of Vaccines ........................................................................................................ 20
Overview ...................................................................................................................... 20
Selected Federal Actions Prior to 2009 .......................................................................... 20
Federal Actions After Emergence of Influenza A(H1N1) ............................................... 21
Legal Issues .................................................................................................................. 23
Mandatory Vaccinations ...................................................................................................... 24
History and Precedent ................................................................................................... 24
Health Care Workers and Mandatory Vaccinations ........................................................ 25
Vaccination Orders During a Public Health Emergency ................................................. 26
Model State Emergency Health Powers Act................................................................... 27
Role of the Federal Government.................................................................................... 27
Civil Rights............................................................................................................................... 28
Introduction ........................................................................................................................ 28
Constitutional Rights to Due Process and Equal Protection.................................................. 29
Federal Nondiscrimination Laws......................................................................................... 31
Section 504 of the Rehabilitation Act ............................................................................ 31
The Americans With Disabilities Act (ADA) ................................................................. 32
The Air Carrier Access Act............................................................................................ 34
Liability Issues.......................................................................................................................... 35
The Public Readiness and Emergency Preparedness Act (PREP Act) ................................... 35
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The 2009 Influenza Pandemic: Selected Legal Issues
Civil Liability of Volunteers and Volunteer Health Professionals.......................................... 36
Volunteer Protection Acts .............................................................................................. 36
Liability Protection During a State of Emergency .......................................................... 37
Emergency Mutual Aid Agreements .............................................................................. 38
Employment Issues ................................................................................................................... 38
Introduction ........................................................................................................................ 38
Wrongful Discharge in Violation of Public Policy ............................................................... 40
The Family and Medical Leave Act ..................................................................................... 42
Overview of Family and Medical Leave Rights ............................................................. 42
State and Federal Laws Providing Employment Protections........................................... 44
Contacts
Author Contact Information ...................................................................................................... 45
Congressional Research Service
The 2009 Influenza Pandemic: Selected Legal Issues
Introduction
On June 11, in response to the global spread of a new strain of influenza, the World Health
Organization (WHO) raised the level of influenza pandemic alert to phase 6, the highest level,
which indicates the start of an actual pandemic.1 This change in alert level reflected the spread of
the new virus, not its severity. In late April 2009, human cases of infection with a novel influenza
A(H1N1) virus were identified. Since then, the virus has become widespread. Although currently
the pandemic is of moderate severity with the majority of patients experiencing mild symptoms
and making a rapid and full recovery, the virus and its effects may change over time. 2 This report
provides a brief overview of selected legal issues including emergency measures, civil rights,
liability issues, and employment issues.
Emergency Measures
Emergency Authorities3
Public Health Emergency Authorities
In response to public health threats, the Secretary of the Department of Health and Human
Services (HHS) can provide a considerable degree of assistance to states through the Secretary’s
general, non-emergency authorities. For example, upon the request of a state health official, and
without the involvement of the President, the Centers for Disease Control and Prevention (CDC)
can provide financial and technical assistance to states for outbreak investigation and disease
control activities. These activities are carried out under the Secretary’s general authority to assist
states at 42 U.S.C. §§ 243(c) and 247b.
There are also a number of authorities in the Public Health Service (PHS) Act that allow the
Secretary of HHS to take certain actions in the face of a “public health emergency.” The principal
authority is in Section 319 of the PHS Act, 42 U.S.C. § 247d(a), which states that
If the Secretary determines, after consultation with such public health officials as may be
necessary, that—(1) a disease or disorder presents a public health emergency; or (2) a public
health emergency, including significant outbreaks of infectious diseases or bioterrorist
attacks, otherwise exists, the Secretary may take such action as may be appropriate to
respond to the public health emergency, including making grants, providing awards for
expenses, and entering into contracts and conducting and supporting investigations into the
cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and
(2).4
1
Dr. Margaret Chan, Director-General of the World Health organization, “World Now at the Start of 2009 Influenza
Pandemic,” http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html.
2
For information on the pandemic status and U.S. government actions, see http://www.cdc.gov/swineflu/,
http://www.dhs.gov/xprepresp/programs/swine-flu.shtm, and http://www.flu.gov. See also CRS Report R40554, The
2009 Influenza Pandemic: An Overview, by (name redacted) and (name redacted).
3
This section was written by (name redacted) and (name redacted).
4
The Secretary is required to provide written notice of determinations under this section to Congress within 48 hours,
but is not required to publish notice of such determinations in the Federal Register. 42 U.S.C. § 247d(a).
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The 2009 Influenza Pandemic: Selected Legal Issues
The then-Acting HHS Secretary issued a nationwide public health emergency declaration in
response to human infections from the influenza A(H1N1) virus on April 26, 2009.5 Making such
a determination enables the Secretary to take three types of actions that can be especially useful
for dealing with an emerging influenza outbreak. First, such a determination authorizes the
Secretary to draw from a special emergency fund. 6 Second, it is one of three events that can lead
to the issuance of Emergency Use Authorizations under the Federal Food, Drug, and Cosmetic
Act to allow for the use of unapproved medical treatments and tests, under specified conditions, if
needed during an incident.7 Third, if there is a concurrent declaration pursuant to either the
Stafford Act8 or the National Emergencies Act,9 the Secretary is authorized to waive or modify
temporarily certain administrative requirements under Section 1135 of the Social Security Act, 10
as necessary to ensure that sufficient healthcare items and services are available to meet the needs
of individuals enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program
(CHIP), and that providers of such services in good faith who are unable to comply with certain
statutory requirements are exempted from sanctions for noncompliance, absent fraud or abuse.
With respect to the 2009 influenza pandemic, and pursuant to the Secretary’s declaration of a
public health emergency under Section 319 of the PHS Act, the Public Health Emergency Fund is
available (but is currently unfunded);11 certain Emergency Use Authorizations have been granted
by FDA;12 and, once the President declared a national emergency under the National Emergencies
Act, the Secretary authorized waivers and modifications under Section 1135 of the Social
Security Act.13
National Emergencies Act Declarations
The National Emergencies Act (NEA)14 authorizes the President to declare a national emergency
and activate existing statutory provisions that authorize the exercise of special or extraordinary
power. The NEA does not provide any specific emergency authority on its own, but relies upon
emergency authorities provided in other statutes. For example, a national emergency declaration
under the NEA could authorize the Secretary of HHS to deploy officers in the Commissioned
Corps of the Public Health Service to agencies outside of HHS in response to an urgent or
emergency public health care need. Emergency statutory provisions are not activated
automatically, but must be specifically identified in the President’s declaration before they may be
given effect.
5
This determination, which would have expired after 90 days, was renewed by HHS Secretary Kathleen Sebelius on
July 24 at http://www.hhs.gov/secretary/phe_swh1n1.html. It was again renewed on October 1, 2009, for an additional
90 days at http://www.flu.gov/professional/federal/h1n1emergency100109.html.
6
The Public Health Emergency Fund does not currently have any monies available. For more information, see CRS
Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name red
acted).
7
See infra at “Emergency Use Authorizations (for Unapproved Countermeasures).”
8
42 U.S.C. § 5121 et seq.
9
50 U.S.C. § 1601 et seq.
10
42 U.S.C. § 1320b-5.
11
See supra note 6.
12
See infra at “Emergency Use Authorizations (for Unapproved Countermeasures).”
13
See infra at “National Emergencies Act Declarations” and “Section 1135 Waivers or Modifications.”
14
42 U.S.C. § 1601 et seq. For more information on the National Emergencies Act, and declarations made under it, see
CRS Report 98-505, National Emergency Powers, by (name redacted).
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The 2009 Influenza Pandemic: Selected Legal Issues
President Barack Obama declared a state of national emergency pursuant to the National
Emergencies Act on October 23, 2009.15 Specifically, the President proclaimed that because “the
rapid increase in illness across the nation may overburden health care resources and ... the
temporary waiver of certain standard Federal requirements may be warranted in order to enable
U.S. health care facilities to implement emergency operations plans, the 2009 H1N1 influenza
pandemic in the United States constitutes a national emergency.” The President further authorized
the Secretary of HHS to “exercise the authority under section 1135 of the Social Security Act to
temporarily waive or modify certain requirements of the Medicare, Medicaid, and State
Children’s Health Insurance programs and of the Health Insurance Portability and Accountability
Act Privacy Rule throughout the duration of the public health emergency declared in response to
the 2009 H1N1 influenza pandemic.”
Stafford Act Declarations
A presidential declaration under the Stafford Act triggers federal emergency authorities that are
independent of the Secretary’s public health emergency authorities. Declarations under the
Stafford Act fall into two categories: emergency declarations and major disaster declarations. As
of this point in time, there have been no Stafford Act declarations pertaining to the 2009 influenza
pandemic. 16 A presidential emergency declaration under the Stafford Act authorizes the President
to direct federal agencies to support state and local emergency assistance activities; coordinate
disaster relief provided by federal and non-federal organizations; provide technical and advisory
assistance to state and local governments; provide emergency assistance through federal agencies;
remove debris through grants to state and local governments; provide assistance to individuals
and households for temporary housing and uninsured personal needs; and assist state and local
governments in the distribution of medicine, food, and consumables.17 The total amount of
assistance available is limited in an emergency declaration to $5 million, “unless the President
determines that there is a continuing need; Congress must be notified if the $5 million ceiling is
breached.”18
Emergency declarations under the Stafford Act in the event of an outbreak of infectious disease
are not unprecedented. In 2000, the detection of West Nile virus in New York and New Jersey
15
The text of the President’s Proclamation, “Declaration of a National Emergency with Respect to the 2009 H1N1
Influenza Pandemic” may be viewed at http://www.whitehouse.gov/the-press-office/declaration-a-national-emergencywith-respect-2009-h1n1-influenza-pandemic-0.
16
Whether a Stafford Act declaration is appropriate for a pandemic incident may be the subject of some debate.
Compare Kevin Robillard, Officials Say Swine Flu Vaccine is Coming, CQ HOMELAND SECURITY, July 9, 2009
(quoting DHS Secretary Janet Napolitano as observing that “the [Stafford] act and the flu do not match up well.”) with
Comments of DHS Deputy Secretary Jane Holl Lute, U.S. Congress, House Committee on Homeland Security, Beyond
Readiness: An Examination of the Current Status and Future Outlook of the National Response to Pandemic Influenza,
111th Cong., 1st sess., July 29, 2009 (indicating that DHS has planned for contingencies in which the Stafford Act is
invoked in response to a pandemic).
17
42 U.S.C. § 5192. Although there are currently significant stockpiles of antiviral medications, if there are large
numbers of individuals infected with H1N1, the demand for antivirals, potential vaccines, and other medical supplies
such as ventilators may exceed the supply. This potential imbalance has led to recommendations for priorities for
medical resources for certain categories of individuals. For a discussion of these recommendations see CRS Report
RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by
(name redacted).
18
42 U.S.C. § 5193(b). See also CRS Report RL33053, Federal Stafford Act Disaster Assistance: Presidential
Declarations, Eligible Activities, and Funding, by (name redacted), at 13-15.
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The 2009 Influenza Pandemic: Selected Legal Issues
19
was used as the basis of an emergency declaration under the Stafford Act. However, there may
be uncertainty regarding whether a flu pandemic, or any outbreak of infectious disease, would be
eligible for major disaster assistance under the Stafford Act. 20
A major disaster declaration authorizes the President to offer all the assistance authorized under
an emergency declaration, and further authorizes funds for the repair and restoration of federal
facilities, unemployment assistance, emergency grants to assist low-income migrant and seasonal
farm workers, food coupons and distribution, relocation assistance, crisis counseling assistance
and training, community disaster loans, emergency communications, and emergency public
transportation.21 Additionally, the total amount of assistance provided in a major disaster
declaration is not subject to a ceiling in the same way as under an emergency declaration.
The authority of the President to declare a major disaster under the Stafford Act in response to a
flu pandemic may be subject to some debate and likely depends upon whether a flu pandemic
would qualify as a “natural catastrophe” under the Stafford Act. FEMA has historically excluded
biological incidents from major disaster declarations under the Stafford Act, but executive policy
under the Bush administration appeared to consider biological incidents, or at least flu pandemics,
22
to be eligible for major disaster assistance.
Although there are differences between the types and amounts of assistance that are authorized by
an emergency or major disaster declaration, either declaration would activate the Secretary’s
waiver or modification authority,23 if concurrent with a public health emergency declaration.
There have been no declarations issued under the Stafford Act with respect to the current
pandemic.
Section 1135 Waivers or Modifications
Section 1135 of the Social Security Act was added by Section 143 of P.L. 107-188, the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002, to authorize the HHS
Secretary to waive certain regulatory requirements related to the provision of health care services
when the President has declared an emergency or major disaster pursuant to either the NEA or the
Stafford Act, and the Secretary of HHS has declared a public health emergency. Waivers under
Section 1135 involve administrative requirements principally relating to reimbursement through
the Medicare and Medicaid programs, in order to facilitate the provision of health care items and
services by providers in an emergency area subject to the concurrent declarations.24 An
emergency area and an emergency period are defined in Section 1135 as the geographic area in
19
CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by
(name redacted), at n.11 and accompanying text; and 65 Fed. Reg. 63589, 67747.
20
See CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding,
by (name redacted), at 10-11. For a more detailed discussionsee CRS Report RL34724, Would an Influenza Pandemic
Qualify as a Major Disaster Under the Stafford Act?, by (name redacted).
21
42 U.S.C. §§ 5172-5187.
22
HOMELAND SECURITY COUNCIL, Implementation Plan for the National Strategy for Pandemic Influenza, at
http://www.whitehouse.gov/homeland/nspi_implementation.pdf. This document “describes more than 300 critical
actions, many of which have already been initiated, to address the threat of pandemic influenza.” See, also, CRS Report
RL34724, Would an Influenza Pandemic Qualify as a Major Disaster Under the Stafford Act?, by (name redacted).
23
See infra at “Section 1135 Waivers or Modifications.”
24
42 U.S.C. § 1320b-5(b).
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The 2009 Influenza Pandemic: Selected Legal Issues
which and time period during which there exists an emergency or disaster declared by the
President pursuant to the National Emergencies Act or the Stafford Act concurrently with a public
health emergency declared by the Secretary pursuant to Section 319 of the PHS Act.25
If Section 1135 conditions are met, then health care facilities may ask the Secretary for “1135
waivers” in response to particular needs within the geographic and temporal areas of the
emergency declarations. Generally, these waivers and modifications may assist patients who must
be relocated due to the inaccessibility of health care facilities in the emergency area, allow
beneficiaries to receive services despite having lost their documentation of eligibility, and allow
providers to provide services in alternate temporary facilities. Specifically, the Secretary may take
some or all of the following actions:
•
waive conditions of participation, certification requirements, program
participation, and pre-approval requirements under Medicare, Medicaid, or the
Children’s Health Insurance Program;26
•
permit health care providers to provide care under Medicare, Medicaid, or the
Children’s Health Insurance Program, even if they are not licensed by the state
with jurisdiction over the emergency area;27
•
waive sanctions under the Emergency Medical Treatment and Active Labor Act
(EMTALA) for certain transfers or redirections of patients away from hospital
emergency rooms;28
•
waive sanctions for violations of the Stark law, which prohibits certain selfreferrals by physicians;29
•
extend deadlines and other timetables for required activities;30
•
waive limitations on payments under Medicare Advantage for care and services
provided by out-of-network providers;31 or
•
waive sanctions and penalties for violations of the HIPAA Privacy Rule such as
the use of protected health information for hospital directories, the disclosure of
protected health information to patients’ families and friends, the distribution of
health care providers’ and insurers’ privacy policies to patients, and individuals’
rights to request restrictions, privacy restrictions, or confidential
communications.32
25
Section 1135(g), 42 U.S.C. §1320b-5(g).
42 U.S.C. § 1320b-5(b)(1).
27
42 U.S.C. § 1320b-5(b)(2). Providers must have equivalent licensing in another state and must not be affirmatively
excluded from practicing in the emergency area.
28
42 U.S.C. § 1320b-5(b)(3). In the event of a pandemic infectious disease, patients can be relocated pursuant to a
state’s pandemic preparedness plan, if one exists. 42 U.S.C. § 1320b-5(b)(3)(B)(ii). For more information on
EMTALA’s requirements, see CRS Report RS22738, EMTALA: Access to Emergency Medical Care, by (name reda
cted).
29
42 U.S.C. § 1320b-5(b)(4). For more information on the Stark law, see CRS Report RS22743, Health Care Fraud
and Abuse Laws Covering Medicare and Medicaid: An Overview, by Jennifer Staman, at 3-5.
30
42 U.S.C. § 1320b-5(b)(5).
31
42 U.S.C. § 1320b-5(b)(6).
32
42 U.S.C. § 1320b-5(b)(7). For more information on HIPAA enforcement, see CRS Report RL33989, Enforcement
of the HIPAA Privacy and Security Rules, by (name redacted).
26
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The 2009 Influenza Pandemic: Selected Legal Issues
These waivers and modifications may be retroactively applied by the Secretary to the beginning
of the period during which the concurrent declarations were in effect, and will generally remain in
effect until the underlying emergency declarations end, or 60 days have elapsed since the date on
which notice of the waivers or modifications was published.33
On October 27, 2009, HHS Secretary Sebelius invoked Section 1135 to waive or modify the
provisions described above, but only to the extent determined necessary or appropriate by the
Centers for Medicare and Medicaid Services. 34 The invocation of Section 1135 covers the period
from October 23, 2009, until expressly revoked, or such time as either the NEA declaration or the
PHE declaration is terminated. The one exception to this general rule is the waiver of HIPAA
privacy provisions, which is limited to those hospitals that have disaster protocols in operation,
and will only apply during the 72 hours following a hospital’s implementation of its disaster
protocol.
Emergency Use Authorizations (for Unapproved Countermeasures)
Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Secretary may
declare that an emergency exists which justifies the expedited use of certain medical
countermeasures (1) on the basis of a determination by the Secretary of Homeland Security that
there is a domestic emergency, or a significant potential for a domestic emergency; (2) on the
basis of a determination by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency; or (3) on the basis of a “determination by the
Secretary [of HHS] of a public health emergency under Section 247d of Title 42 that affects, or
has a significant potential to affect, national security, and that involves a specified biological,
chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be
attributable to such agent or agents.” Although a declaration under Section 564 of the FFDCA
may be based on the declaration of a public health emergency under Section 319 of the PHSA,
the two are distinct. An FFDCA emergency declaration lasts up to a year, but can be renewed. 35
Upon a declaration under Section 564, the FDA commissioner may authorize the emergency use
of a drug, device, or biological product during the effective period of the declaration. 36 An
Emergency Use Authorization (EUA) may apply to a product that is not currently approved for
commercial use by the Food and Drug Administration (FDA).37 Alternatively, the subject of an
EUA may already be an FDA-approved product, but the emergency use justifying the EUA may
be one that is not presently approved by the FDA. 38 For example, a drug may be approved for use
in the adult population but not for use in children, in which case an EUA may sanction its use by
33
42 U.S.C. § 1320b-5(e)(1). The Secretary may extend the effect of any waivers or modifications in 60-day
increments. 42 U.S.C. § 1320b-5(e)(2).
34
HHS Secretary, “Waiver or Modification of Requirements Under Section 1135 of the Social Security Act,” Oct. 27,
2009, available at http://www.flu.gov/professional/federal/h1n1_1135waiver_10272009.html.
35
21 U.S.C. § 360bbb-3(b)(2). The HHS Secretary must publish “each declaration, determination, advance notice of
termination, and renewal” in the Federal Register. 21 U.S.C. § 360bbb-3(b)(4).
36
21 U.S.C. § 360bbb-3(a)(1). The authority to issue EUAs statutorily resides with the HHS Secretary, but has been
administratively delegated to the FDA commissioner. See 21 U.S.C. § 393(d)(2) and FDA, Staff Manual Guide
1410.10.
37
21 U.S.C. § 360bbb-3(a)(2)(A).
38
21 U.S.C. § 360bbb-3(a)(2)(B).
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children. A drug may also be approved only for a specific disease, in which case an EUA may
permit the drug’s use for treating different conditions.
The issuance of an EUA must also be supported by a number of findings.39 First, the FDA
commissioner must conclude that the underlying agent for which the emergency declaration was
made can cause a serious or life-threatening disease or condition. Second, the commissioner must
conclude, based on available scientific evidence, that (1) it is reasonable to believe that the
product may be effective in diagnosing, treating, or preventing the disease or condition or that the
product may be effective in diagnosing, treating, or preventing a serious or life-threatening
disease or condition caused by a product authorized for emergency use40 and (2) it is reasonable
to believe that the known and potential benefits of the product outweigh its known and potential
risks. Third, the commissioner must conclude that there is no adequate, approved, and available
alternative to the product for diagnosing, preventing, or treating such disease or condition.
Finally, the commissioner must conclude that any other criteria for EUAs, which are prescribed in
regulation, are met.
On April 27, 2009, the FDA issued four Emergency Use Authorizations in response to requests
from the CDC to make available certain drugs, diagnostic tests, and respiratory protection devices
for the response to the H1N1 influenza outbreak. 41 In July of 2009, emergency use of a second
unapproved diagnostic test was authorized,42 in August of 2009, the FDA authorized the
emergency use of an H1N1 diagnostic test “to detect the virus in [American] troops serving
overseas,” and on October 23, 2009, the FDA authorized the emergency use of intravenous
antiviral Peramivir for H1N1 influenza for certain patients and in certain settings. 43
International Health Regulations (IHR)44
Overview of the IHR
In May 2005, the World Health Assembly adopted a revision of its 1969 International Health
Regulations, giving a new mandate to the World Health Organization (WHO) and member states
to increase their respective roles and responsibilities for the protection of international public
health.45 The IHR(1969) had focused on just three diseases (cholera, plague, and yellow fever). In
39
21 U.S.C. § 360bbb-3(c). In making these findings, the commissioner must consult with the directors of the National
Institutes of Health and the Centers for Disease Control and Prevention prior to issuing the EUA.
40
For example, Vaccinia Immune Globulin (VIG) may be used to treat complications that result from smallpox
vaccinations. See CDC, Smallpox Vaccination – Vaccine Immune Globulin, available at http://www.bt.cdc.gov/training/
smallpoxvaccine/reactions/vig.html.
41
See statement of Joshua M. Sharfstein, Acting Commissioner, FDA, before the Committee on Energy and
Commerce, Subcommittee on Health, April 30, 2009, 111th Cong., 1st sess. Washington, D.C. See also the CDC’s
website at http://www.cdc.gov/h1n1flu/eua/.
42
See FDA, “FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus,” press release, July 24,
2009, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm.
43
FDA, “FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas,” press release, Aug. 25,
2009, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180153.htm. See also the FDA press
release regarding Peramivir at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187813.htm.
44
This section was written by (name redacted), Legislative Attorney.
45
Fifty-eighth World Health Assembly, agenda item 13.1, Revision of the International Health Regulations, May 23,
2005, at http://www.who.int/csr/ihr/en/.
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addition, compliance of State Parties46 with the IHR(1969) was uneven, a result of, among other
things, resource limitations in poorer countries, and political factors, such as the reluctance to
announce the presence of a contagious disease within one’s borders and face economic and other
consequences.47
The IHR(2005), which entered into force in June 2007, have broadened the scope of the 1969
regulations by addressing existing, new, and re-emergent diseases, as well as emergencies caused
by non-infectious disease agents.48 The IHR(2005) also include provisions regarding designated
national points of contact, definitions of core public health capacities, disease control measures
such as quarantine and border controls, and others. The IHR(2005) require WHO to recommend,
and State Parties to use, control measures that are no more restrictive than necessary to achieve
the desired level of health protection.
The IHR were agreed upon by a consensus process among the member states, and represent a
balance between sovereign rights and a commitment to work together to prevent the international
spread of disease. The IHR(2005) are binding on all WHO member states as of June 15, 2007,
except for those that have rejected the regulations or submitted reservations.49 While the
IHR(2005) contain mechanisms such as negotiation and arbitration to assist States Parties in
reaching mutually acceptable solutions where disputes arise, ultimately IHR(2005) do not provide
an enforcement mechanism to compel compliance with WHO provisions.50 The United States
accepted the IHR(2005) with three reservations, including the reservation that it will implement
the IHR(2005) in line with U.S. principles of federalism. 51 Within five years of the entry into
force date, State Parties must complete development of public health infrastructure that ensures
full compliance with the regulations.
Declaration of a “Public Health Emergency of International Concern”
On April 25, 2009, WHO Director-General Dr. Margaret Chan, upon the advice of the Emergency
Committee, declared that the influenza A(H1N1) virus outbreak constituted a “Public Health
Emergency of International Concern” under the IHR(2005).52 This influenza outbreak marked the
first time under the IHR(2005) that the Director-General convened the Emergency Committee
and determined that a “Public Health Emergency of International Concern” existed. Article 12(1)
of the IHR(2005) authorizes the WHO Director-General to make such a declaration, and Article 1
of the IHR(2005) defines a “Public Health Emergency of International Concern” as “an
extraordinary event which is determined ... (i) to constitute a public health risk to other States
through the international spread of disease and (ii) to potentially require a coordinated
international response.”
46
“State Party” is the name for WHO member states that have agreed to be bound by the IHR.
M.G. Baker and D.P. Fidler, “Global Public Health Surveillance under New International Health Regulations,”
Emerging Infectious Diseases, vol. 12, no. 7, July 2006, at http://www.cdc.gov/ncidod/EID/vol12no07/05-1497.htm.
48
The full text of the IHR 2005 may be found at http://www.who.int/csr/ihr/IHR_2005_en.pdf.
49
IHR(2005), Article 59.2.
50
IHR, Article 56.
47
51
HHS Secretary Michael Leavitt announced the acceptance of the IHR(2005) by the United States on December 13,
2006. See News Release at http://www.pandemicflu.gov/plan/federal/index.html.
52
WHO, Statement by the WHO Director-General on Influenza A (H1N1), April 25, 2009, available at
http://www.who.int/mediacentre/news/statements/2009/h1n1_20090425/en/index.html.
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WHO Recommendations
Under the IHR(2005), if the WHO Director-General declares a “Public Health Emergency of
International Concern,” then the Director-General must issue temporary recommendations which
will depend upon the nature of the threat (Article 15(1)). The IHR(2005) do not preclude State
Parties from implementing measures that achieve a greater level of health protection than WHO
temporary recommendations, provided that such measures are (1) otherwise consistent with the
IHR(2005), and (2) not more restrictive of international trade and travel, and not more invasive or
intrusive to persons, than reasonably available alternatives that would achieve the appropriate
level of health protection (Article 43(1)). Following the declaration of a “Public Health
Emergency of International Concern” on April 25, 2009, the Director-General recommended that
“all countries should intensify surveillance for unusual outbreaks of influenza-like illness and
severe pneumonia.”53 The Director-General, however, did not recommend any travel or trade
restrictions.
On June 11, 2009, the WHO Director-General announced that the scientific criteria for an
influenza pandemic had been met with regard to the influenza A(H1N1) virus, so that the WHO
pandemic alert level was raised from 5 to 6.54 Again, no travel, border closures, or trade
restrictions were recommended.
International Response to WHO Recommendations
The WHO advised that travel restrictions would have “very little effect on stopping the virus from
spreading, but would be highly disruptive to the travel community.”55 Despite this
recommendation, some countries, such as China and several South American countries,
implemented outright travel bans to or from Mexico. Other countries interrupted sales of pork
products from the United States, disregarding a WHO determination, confirmed by scientists, that
cooked pork does not transmit the virus.56
According to the IHR(2005), State Parties may apply measures that affect travel, even if not
recommended by the Director-General.57 However, such measures must be no more restrictive of
travel, or more intrusive to persons, than reasonably available alternatives that would achieve the
appropriate level of health protection. Thus, State Parties are not supposed to bar the entry of a
conveyance for public health reasons, but rather are to manage a public health threat through
isolation, quarantine, disinfection, or other such applicable methods.58 If a State Party implements
additional health measures significantly interfering with international traffic, the public health
53
Id.
Dr. Margaret Chan, Director-General of the World Health organization, “World Now at the Start of 2009 Influenza
Pandemic,” http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html.
55
WHO, Epidemic and pandemic alert and response (EPR)/ Travel: is it safe to travel? Available at
http://www.who.int/csr/disease/swineflu/frequently_asked_questions/travel/en/index.html. See also CRS Report
R40588, The 2009 Influenza Pandemic: U.S. Responses to Global Human Cases , by (name redacted).
56
Rebecca Katz, “Use of Revised International Health Regulations During Influenza A(H1N1) Epidemic, 2009,” 15
EMERG INFECT DIS. 1165-1170 (August 2009).
57
IHR, Article 42, “Additional Health Measures.” In addition, despite scientific evidence that eating pork does not
cause influenza, a number of countries banned pork products. See CRS Report R40575, Potential Farm Sector Effects
of 2009 H1N1 “Swine Flu”: Questions and Answers, by (name redacted), for a discussion of international responses to
restrictions on pork products following the influenza A(H1N1) outbreak.
58
IHR, Article 28.1, “Ships and aircraft at points of entry.”
54
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rationale and relevant scientific information for the measures must be provided to WHO. The
WHO will then share the information with State Parties and institute procedures to find a
mutually acceptable solution.59 Ultimately, however, the IHR(2005) do not provide an
enforcement mechanism to compel compliance with WHO recommendations.60
Quarantine and Isolation Authority61
Federal Authorities
Although the terms are often used interchangeably, quarantine and isolation are two distinct
concepts. Quarantine typically refers to the “(s)eparation of individuals who have been exposed to
an infection but are not yet ill from others who have not been exposed to the transmissible
infection.”62 Isolation refers to the “(s)eparation of infected individuals from those who are not
infected.”63 Primary quarantine authority typically resides with state health departments and
health officials; however, the federal government has jurisdiction over interstate and border
quarantine.
Federal quarantine and isolation authority may be found in Section 361 of the Public Health
Service Act, 42 U.S.C. § 264, wherein Congress has given the Secretary of HHS the authority to
make and enforce regulations necessary “to prevent the introduction, transmission, or spread of
communicable diseases from foreign countries into the States or possessions, or from one State or
possession into any other State or possession.”64 While also providing the Secretary with broad
authority to apprehend, detain, or conditionally release a person, the law limits the Secretary’s
authority to the communicable diseases published in an Executive Order of the President. 65
Executive Order 13295 lists the communicable diseases for which this quarantine authority may
be exercised, and specifically includes influenza viruses which have the potential to cause a
pandemic. 66 In 2000, the Secretary of HHS transferred certain authorities, including interstate
59
IHR, Article 43, “Additional Health Measures.” While the IHR(2005) do not include an enforcement mechanism for
State Parties that fail to comply with their provisions, the WHO considers the potential consequences of noncompliance within the global community, especially in economic terms, to be a powerful compliance tool. The
IHR(2005) (Article 56) contain a dispute settlement mechanism to resolve conflicts which may arise among State
Parties when applying or interpreting the regulations, including options such as negotiation, mediation, conciliation, or
arbitration, or referral to the Director-General of WHO, if agreed to by all the parties to the dispute.
60
Lawrence O. Gostin, “Influenza A(H1N1) and Pandemic Preparedness Under the Rule of International Law,” 301
JAMA 2376-2378 (June 10, 2009).
61
This section was written by (name redacted), Legislative Attorney. For a detailed discussion of quarantine
and isolation, see CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by (name redact
ed) and (name redacted).
62
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan (GPO May 2006). For a
discussion of the history of quarantines in the United States see Felice Batlan, “Law in the Time of Cholera: Disease,
State Power, and Quarantines Past and Future,” 80 TEMP. L. REV. 53 (2007).
63
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan (GPO May 2006).
64
42 U.S.C. § 264(a). Violation of federal quarantine and isolation regulations is a criminal misdemeanor, punishable
by fine and/or imprisonment, 42 U.S.C. § 271.
65
42 U.S.C. § 264(b).
66
See also E.O. 13375, April, 2005, which amended E.O. 13295. The diseases listed are cholera, diphtheria, infectious
tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and
influenza viruses which have the potential to cause a pandemic. Other new threats would have to be added to E.O.
13295 in order to be “quarantinable diseases.”
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quarantine authority, to the Director of the CDC.67 Both interstate and foreign quarantine
measures are now carried out by CDC’s Division of Global Migration and Quarantine. 68
HHS also works closely with the Department of Homeland Security (DHS) and its agencies. HHS
and DHS signed a memorandum of understanding in 2005 that sets forth specific cooperation
mechanisms to implement their respective statutory responsibilities for quarantine and other
public health measures.69 DHS has three agencies that may aid CDC in its enforcement of
quarantine rules and regulations pursuant to 42 U.S.C. § 268(b). They are U.S. Customs and
Border Protection, U.S. Immigration and Customs Enforcement, and the United States Coast
Guard. In addition to DHS, CDC may also rely on other federal law enforcement agencies and
state and local law enforcement agencies.
Federal and State Coordination
While the federal government has authority to authorize quarantine and isolation under certain
circumstances, it should be noted that the primary authority for quarantine and isolation exists at
the state level as an exercise of the state’s police power. States conduct these activities in
accordance with their particular laws and policies. 70 CDC acknowledges this deference to state
authority as follows:
In general, CDC defers to the state and local health authorities in their primary use of their
own separate quarantine powers. Based upon long experience and collaborative working
relationships with our state and local partners, CDC continues to anticipate the need to use
this federal authority to quarantine an exposed person only in rare situations, such as events
at ports of entry or in similar time-sensitive settings.71
Section 311 of the PHS Act72 provides for federal-state cooperative activities to enforce
quarantines. The federal government may help states and localities enforce their quarantines and
67
42 C.F.R. Part 70. Regulations regarding quarantine upon entry into the United States from foreign countries are also
administered by the CDC, see 42 C.F.R. Part 71.
68
See CDC Division of Global Migration and Quarantine home page at http://www.cdc.gov/ncidod/dq/index.htm.
69
http://www.dhs.gov/xnews/testimony/testimony_1181229544211.shtm.
70
A new development in the law relating to quarantine is the possible use of self-imposed or home quarantines. States
may need to consider whether their ability to impose quarantine also includes the authorities necessary to support a
population asked to voluntarily stay at home for a period of time. Federal and state authorities generally provide for the
care of persons mandatorily quarantined, but voluntary home-quarantine situations may pose new issues. See Steven D.
Gravely, et al., Emergency Preparedness and Response: Legal Issues in a Changing World, 17 THE HEALTH LAWYER 1
(June 2005).
71
Q&A on Executive Order 13295, available at http://www.cdc.gov/ncidod/dq/
qa_influenza_amendment_to_eo_13295.htm. The complexities of this shared power have been noted. One analysis
observed that “When it comes to the exercise of isolation and quarantine powers, reality tends to be messier than the
conceptual realm. Public health officials need clear lines of authority in emergency situations, often the moments when
isolation and quarantine might be required. Unfortunately, confusion about which level of government should take the
lead often occurs, thus revealing the ability of quarantine powers to spotlight difficulties federalism poses for public
health.” David P. Fidler, Lawrence O. Gostin, and Howard Markel, “Through the Quarantine Looking Glass: DrugResistant Tuberculosis and Public Health Governance, Law and Ethics,” 35 J. OF LAW, MEDICINE & ETHICS 616 (2007).
Another commentator has noted that “Given the variation in due process rights in connection with quarantine, which
may be afforded under federal and state law, one can foresee the possibility of considerable conflict.” Felice Batlan,
“Law in the Time of Cholera: Disease, State Power, and Quarantines Past and Future,” 80 TEMP. L. REV. 53, 119
(2007).
72
42 U.S.C. § 243.
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other health regulations and, in turn, may accept state and local assistance in enforcing federal
quarantines. The federal government may also assist with or take over the management of an
intrastate incident if requested by a state or if the federal government determines local efforts are
inadequate. 73 Under the authority of 42 U.S.C. § 97, the Secretary of HHS may request the aid of
U.S. Customs and Border Protection, Coast Guard, and military officers in the execution of
quarantines imposed by states on vessels coming into ports.
Proposed Federal Regulations
The CDC, on November 22, 2005, announced proposed changes to its quarantine regulations at
42 C.F.R. Parts 70 and 71.74 These proposed regulations have not been finalized, but Congress
subsequently mandated that they be promulgated by June 10, 2009.75 These changes will
constitute the first significant revision of the regulations in Parts 70 and 71 in 25 years. The
proposed changes are an outgrowth of the CDC’s experience during the spread of Severe Acute
Respiratory Syndrome (SARS) in 2003, when the agency experienced difficulties locating and
contacting airline passengers who might have been exposed to SARS during their travels. In
announcing the proposed regulations, then CDC Director Julie Gerberding said, “[t]hese updated
regulations are necessary to expedite and improve CDC operations by facilitating contact tracing
and prompting immediate medical follow up of potentially infected passengers and their
contacts.”76
The proposed regulations would expand reporting requirements for ill passengers77 on board
flights and ships arriving from foreign countries. They would also require airlines and ocean
liners to maintain passenger and crew lists with detailed contact information and to submit these
lists electronically to CDC upon request.78 The lists would be used to notify passengers of their
suspected exposure if a sick person were not identified until after the travelers had dispersed from
an arriving carrier. The proposed regulations address the due process rights of passengers who
might be subjected to quarantine after suspected exposure to disease; the regulations also provide
for an appeal process. 79
73
42 U.S.C. § 264 (c) and 42 C.F.R. § 70.2.
See 70 Fed. Reg. 71892 (November 30, 2005), http://www.cdc.gov/ncidod/dq/nprm/. These proposed regulations
were available for a 60-day comment period, which was extended for an additional 30 days, closing on March 1, 2006.
See 71 Fed. Reg. 4544 (January 27, 2006), proposed Section 70.20 and 71.23 of 42 C.F.R.
75
Section 121(c) of P.L. 110-392 states: “Not later than 240 days after the date of enactment of this Act, the Secretary
of Health and Human Services shall promulgate regulations to update the current interstate and foreign quarantine
regulations found in parts 70 and 71 of Title 42, Code of Federal Regulations.”
76
“CDC Proposes Modernizing Control of Communicable Disease Regulation, USA,” Medical News Today,
November 23, 2005, at http://www.medicalnewstoday.com/medicalnews.php?newsid=34042. Since the SARS
outbreak, the CDC has increased its quarantine stations nationwide from 8 to 20. See http://www.cdc.gov/ncidod/dq/
index.htm.
77
The definition of ill person would be expanded to include anyone who has a fever of at least 100.4 degrees plus one
of the following: severe bleeding, jaundice, or severe, persistent cough accompanied by bloody sputum, or respiratory
distress. (Section 70.1 of proposed regulations).
74
78
Id. The lists, in electronic format, would have to be kept for 60 days after arrival, and be able to be submitted within
12 hours of a CDC request. The lists would include names, contact information and seat assignments.
79
Proposed section 70.20 and 71.23 of 42 CFR.
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Border Entry Issues 80
Inadmissibility of Infected Aliens
Those most easily excluded from the United States are aliens already infected with the influenza
A(H1N1) virus. The Immigration and Nationality Act (INA) specifically bars aliens who are
determined to have “a communicable disease of public health significance,” from receiving visas
and admission into the United States.81 “A communicable disease of public health significance” is
defined by the Secretary of Health and Human Services by regulation.82 Although the regulatory
definition does not specifically include influenza A(H1N1), it does include, by reference,
communicable diseases as listed in a Presidential Executive Order issued pursuant to section
361(b) of the Public Health Service Act.83 The relevant order, Executive Order 13295, as
amended by Executive Order 13375, specifies “[i]nfluenza caused by novel or reemergent
influenza viruses that are causing, or have the potential to cause, a pandemic” as a communicable
disease for purposes of section 361(b). 84 Thus, for purposes of the INA, the influenza A(H1N1)
virus is a ground for inadmissibility into the United States. Of course, this law only applies to
aliens, not citizens, and prior to inadmissibility being triggered, the alien must be diagnosed with
the influenza A(H1N1) virus.85 These considerations could therefore prevent this provision from
being the most effective means to interdict individuals infected with the influenza A(H1N1) virus
from entering the country.
Border Quarantines of Citizens or Aliens
There are currently no legal provisions that can exclude American citizens from the United States
solely because of an infection with a communicable disease. The primary means to prevent
infected citizens from introducing these diseases into the United States is to place them into
quarantine or isolation at the border rather than deny them entry outright. As noted above, the
Secretary has the authority to promulgate regulations to prevent the entry and spread of
communicable diseases from foreign countries into the United States. The implementing
regulations at 42 C.F.R. Part 71 specify that when there is reason to believe an arriving person is
infected with “any communicable disease listed in an Executive Order, as provided under section
361(b) of the Public Service Act,” the person may be isolated, quarantined, or placed under
surveillance or disinfected if deemed necessary to prevent the introduction of the communicable
disease. 86 “Influenza caused by novel or reemergent influenza viruses that are causing, or have the
potential to cause, a pandemic” is one such disease that can warrant quarantine. 87
80
This section was written by Yule Kim, Legislative Attorney.
INA § 212(a)(1), 8 U.S.C. §1182(a)(1) (Any alien who is determined (in accordance with regulations prescribed by
the Secretary of Health and Human Services) to have a communicable disease of public health significance…is
inadmissible).
82
42 C.F.R. § 34.2(b).
83
42 U.S.C. § 264.
84
Exec. Order No. 13295, 68 FR 17255 (April 4, 2003) as amended by Exec. Order. No. 13375, 70 FR 17299 (April 1,
2005).
85
As a practical matter, there is not currently a real-time test that could be used to determine whether an apparently ill
person is infected with this virus. Tests currently available require a day or more to perform.
81
86
42 C.F.R. § 71.32.
Exec. Order No. 13295, 68 FR 17255 (April 4, 2003) as amended by Exec. Order. No. 13375, 70 FR 17299 (April 1,
(continued...)
87
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Closing the Border
The most drastic measure discussed so far is “to close the borders.” Presumably, this would entail
a blanket bar on all aliens and citizens seeking entry into the United States regardless of their
health. There appear to be no laws specifically authorizing an executive agency to take such
action. However, Congress could presumably enact a law to do so, at least with regard to aliens,
because the Supreme Court has long recognized “the power to expel or exclude aliens as a
fundamental sovereign attribute that is largely immune from judicial control. 88 However, United
States citizens cannot be barred from entering the United States.89 Thus, if Congress were to
theoretically “close the borders,” it could do so only by excluding aliens.
In the absence of an act of Congress, it may be possible for the President to “close the borders” to
aliens by Executive Order. However, this course of action appears to be fraught with legal and
practical challenges, which would likely result in extensive litigation. Because Congress has not
given the President authority to conduct blanket closings of borders, it would appear that the
President could do so only if the exclusion power is one where he has concurrent authority with
Congress.90 Although this exclusion power is characterized as a power “exercised by the
Government’s political departments largely immune from judicial control,”91 the President
appears to have rarely exercised any authority within this realm outside of the authority expressly
delegated by an act of Congress. Considering the rather extensive inadmissibility regime codified
within the Immigration and Nationality Act, it would appear unlikely that the President can
exercise this power without express congressional authorization.
Airlines and Travel Restrictions92
Airline Corporate Policies
Generally, airlines are under no legal obligation to provide transportation simply because a person
has a valid ticket. As a matter of corporate policy, airlines have inserted clauses into their
“contract of carriage” reserving the right to deny transportation to any ticketed passenger who
presents himself or herself in a condition that may adversely affect the safety and/or security of
the flight, its crew, or the other passengers. For example, Midwest Airlines’ “contract of carriage”
specifically authorizes the refusal of transportation or removal from a flight if the passenger’s:
age, mental or physical condition, disability or impairment is such that the passenger would
need excessive or unusual assistance in the event of an emergency or to take care of his/her
physical needs in flight.93
(...continued)
2005).
88
Shaughnessy v. United States ex rel. Mezei, 345 U.S. 206, 210 (1953). See also Chae Chan Ping v. United States,
130 U.S. 581, 609 (1889) (Chinese Exclusion Case) (Bradley, J., concurring).
89
United States v. Wong Kim Ark, 169 U.S. 649, 653 (1898) (holding that a person born in the United States could not
be excluded from the country by the Chinese Exclusion Act); Perez v. United States, 502 F. Supp. 2d 301, 306
(N.D.N.Y. 2006).
90
Youngstown Sheet and Tube Co. v. Sawyer, 343 U.S. 579, 637 (1952) (Jackson, J., concurring).
91
Meizei, 345 U.S. at 210.
92
This section was written by (name redacted), Legislative Attorney.
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Thus, it is conceivable that a person presenting himself or herself for air travel with symptoms of
illness could be denied the right to board.94 Application and interpretation of this provision
appears to be at the sole discretion of the air carrier. Should an individual be refused
transportation, he or she may, depending on the terms of the “contract of carriage,” be eligible for
a refund for any unused portion of the ticket purchased minus any taxes or applicable service
fees.
CDC has issued interim guidance to assist airline crew in identifying passengers who may be
infected with influenza A(H1N1).95 This guidance provides that any passengers with certain
symptoms should be reported immediately to the CDC quarantine station in the airport where the
plane is expected to land.
Public Health “Do Not Board” List
Federal agencies have developed a new travel restriction tool to prevent the spread of
communicable diseases of public health significance. 96 The public health Do Not Board (DNB)
list was developed by the Department of Homeland Security (DHS) and the CDC, and made
operational in June 2007.97 The DNB list enables domestic and international health officials to
request that persons with communicable diseases who meet specific criteria and pose a serious
threat to the public be restricted from boarding commercial aircraft departing from or arriving in
the United States. The list provides a new tool for management of emerging public health threats
when local public health efforts are not sufficient to keep people with certain contagious diseases
from boarding commercial flights.98
Federal Airspace Authority
In addition to the legal authority over individual passengers, the federal government possesses the
legal authority to regulate and control the navigable airspace of the United States. The notion that
every nation has absolute and exclusive sovereignty over the airspace above its defined territory
is a hallmark aviation principle that has been recognized by international agreements dating back
(...continued)
93
See Midwest Airlines, Contract of Carriage, available at, http://www.midwestairlines.com/uploadedFiles/
Travel_Tools/Travel_Policies/ContractofCarriage_20081222.pdf
94
Airlines also have general authority to refuse to board passengers with communicable diseases under certain
circumstances pursuant to Air Carrier Access Act of 1986 (ACAA) regulations. See 49 U.S.C. § 41705, 14 C.F.R. §
382.51. Decisions to deny passengers scheduled to fly must be based on “reasonable judgment that relies on current
medical knowledge or on the best available objective evidence,” that the individual poses a direct threat to the health
and safety of others. See, discussion, infra at “Federal Nondiscrimination Laws”, regarding the application of federal
nondiscrimination laws, including the nondiscrimination provisions of the ACAA.
95
http://www.cdc.gov/h1n1flu/aircrew.htm
96
For a summary of recent actions taken by DHS and the CDC to improve procedures to restrict persons with serious
communicable diseases who intend to travel despite medical advice, see Government Accountability Office, Public
Health and Border Security: HHS and DHS Should Further Strengthen Their Ability to Respond to TB Incidents. GAO09-58. Washington, D.C: October, 2008.
97
CDC. Federal Air Travel Restrictions for Public Health Purposes—United States, June 2007-May 2008, MMWR
2008 Sep. 19; 57 (37): 1009-12, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5737a1.htm.
98
The list, which applies to all citizens and foreign nationals, appears to have been developed under the general
authority of the Aviation and Transportation Security Act of 2001, at 49 U.S.C. § 114(f) and (h).
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to the 1919 Convention for the Regulation of Aerial Navigation. 99 The United States Congress
has, by statute, delegated the legal authority over airspace regulation to the Administrator of the
Federal Aviation Administration (FAA).100 Pursuant to this authority, it appears that the FAA can
prevent airplanes from entering the airspace of the United States if they originate from a country
experiencing incidents of communicable disease (e.g., airplane from Mexico to any airport in the
United States). Similarly, the FAA could deny airspace access to any airplane originating in the
United States whose intention it is to operate into a country experiencing incidents of
communicable disease (e.g., an airplane from any domestic airport to Mexico). Finally, the FAA
can prevent aircraft originating in third countries from utilizing the airspace of the United States
to travel to a country experiencing incidents of communicable disease (e.g., airplane originating
in Canada destined for Mexico).
School Closures101
Since children tend to be more susceptible than adults to infection and are responsible for more
secondary transmission,102 studies have suggested that community-wide school closures may help
mitigate the impact of an influenza pandemic.103 The Centers for Disease Control and Prevention
(CDC), in interim pre-pandemic planning guidance, included school closures as a tool for
mitigation of a pandemic and, in some cases, the period of closure could be as long as 12
weeks.104 During the spring 2009 H1N1 influenza outbreak over 700 schools closed for varying
lengths of time. 105 However, additional information on the virus led to less use of school closures.
CDC issued revised guidance on May 5, 2009, and noted that new information, indicating the
99
Convention for the Regulation of Aerial Navigation, Oct. 13, 1919, Art. 1, 11 L.N.T.S. 173, 190.
49 U.S.C. § 40103 (2006).
101
This section was written by (name redacted), Legislative Attorney. For more information on the school closure
issue see CRS Report R40554, The 2009 Influenza Pandemic: An Overview, by (name redacted) and (name redac
ted).
102
U.S. Department of Education, H1N1 Flu and U.S. Schools: Answers to Frequently Asked Questions,
http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flu-faqs.pdf.
103
Centers for Disease Control and Prevention, Interim Pre-pandemic Planning Guidance: Community Strategy for
Pandemic Influenza Mitigation in the United States, at 27. http://www.pandemicflu.gov/plan/community/
community_mitigation.pdf. Other school policies may also have an effect on the spread of an influenza virus. The
National Association of State Boards of Education (NASBE) updated its statement on influenza and school
preparedness to suggest that “[s]tates may want to consider adding the flu vaccination to the list of mandatory
immunizations children are required to have to attend school.” http://www.nasbe.org/index.php/file-repository?func=
startdown&id=887.
104
Centers for Disease Control and Prevention, Interim Pre-pandemic Planning Guidance: Community Strategy for
Pandemic Influenza Mitigation in the United States, http://www.pandemicflu.gov/plan/community/
community_mitigation.pdf. CDC has also issued guidance relating to higher education. See http://www.cdc.gov/
h1n1flu/guidance/guidelines_colleges.htm.
105
The U.S. Department of Education responded to the spring 2009 H1N1 outbreak by holding a conference call on
school closures with state and district education officials, http://www.ed.gov/admins/lead/safety/emergencyplan/
pandemic/guidance/trans042709.pdf; publishing guidance, U.S. Department of Education, H1N1 Flu and U.S. Schools:
Answers to Frequently Asked Questions, http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flufaqs.pdf, http://www.pandemicflu.gov/plan/school/index.html; and other information, http://www.ed.gov/admins/lead/
safety/emergencyplan/pandemic/guidance/flu-faqs.pdf, http://rems.ed.gov/index.cfm?event=
PandemicPreparedns4Schools. In addition, President Obama originally called for school closures if there were students
ill with the influenza A(H1N1) virus, http://www.whitehouse.gov/blog/09/04/30/The-Presidents-Remarks-on-H1N1.
As of May 5, 2009, 726 schools out of more than 100,000 nationwide were closed due to the outbreak. Frank Wolfe,
“NASBE: Schools Should Consider Mandatory Flu Shots,” 42 Education Daily No. 83, at 3 (May 6, 2009).
100
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The 2009 Influenza Pandemic: Selected Legal Issues
disease severity was similar to that of seasonal influenza, warranted revision of the original
recommendation.106
On August 7, 2009, CDC issued new guidelines for elementary and secondary schools to help
decrease the spread of flu among students and school staff.107 This guidance emphasizes that
“[t]he decision to dismiss students should be made locally and should balance the goal of
reducing the number of people who become seriously ill or die from influenza with the goal of
minimizing social disruption and safety risks to children sometimes associated with school
dismissal.”108 The recommended school responses are staying home when sick for at least 24
hours after a fever, separating ill students and staff, using hand hygiene, routinely cleaning
commonly touched surfaces, treating high-risk students and staff early, and considering selective
school dismissals.109 If the flu appears to be causing more severe disease, other additional
measures may be recommended, including active screening for fevers, advising high-risk students
and staff to stay home, advising students with ill household members to stay home, and school
dismissals.110 WHO has issued similar advice relating to schools, noting that “[e]xperience to date
has demonstrated the role of schools in amplifying transmission of the pandemic virus, both
within schools and into the wider community.”111
CDC and the Department of Education (ED) have established a school dismissal monitoring
system in order to track school dismissals.112 During testimony before the Senate Committee on
Homeland Security and Government Affairs on October 21, 2009, Secretary Duncan stated that
from August 3 through October 9, 501 schools had closed for at least one day. 113 In addition, ED
has provided recommendations to help schools maintain the continuity of learning both for
individuals or small groups of students and for large groups of students disrupted by school
dismissals or large numbers of faculty absences. 114
106
The updated guidance recommended that schools not close for suspected or confirmed cases of influenza A(H1N1)
unless the number of faculty or students absent interferes with the school’s ability to function. In addition, it was
recommended that the schools that were closed reopen. http://www.cdc.gov/h1n1flu/K12_dismissal.htm;
http://www.cdc.gov/h1n1flu/mitigation.htm.
107
http://www.flu.gov/plan/school/schoolguidance.html; http://www.flu.gov/plan/school/k12techreport.html. See also
“Preparing for the Flu (Including 2009 H1N1 Flu): A Communication Toolkit for Schools (Grades K-12),”
http://www.flu.gov/plan/school/toolkit.html. Separate updated guidance for child care settings will be issued.
108
http://www.flu.gov/plan/school/schoolguidance.html. School closures have a direct economic cost due to worker
absenteeism, including absenteeism by health care workers. A study by the Brookings Institute found that closing all
the schools in the U.S. for four weeks could cost between $10 billion and $47 billion dollars and lead to a reduction of
6% to 19% in key health care personnel. Howard Lempel, Ross A. Hammond, Joshua M. Epstein, “Economic Cost and
Health Care Workforce Effects of School Closures in the U.S.,” Center on Social and Economics Dynamics Working
Paper No. 55 (September 30, 2009), http://www.brookings.edu/papers/2009/
0930_school_closure_lempel_hammond_epstein.aspx.
109
Id.
110
Id.
111
WHO, “Measures in School Settings,” Pandemic (H1N1) 2009 Briefing Note 10, http://www.who.int/csr/disease/
swineflu/notes/h1n1_school_measures_20090911/en/index.html.
112
http://www.cdc.gov/h1n1flu/schools/dismissal_form/index.htm.
113
H1N1 Flu: Monitoring the Nation’s Response: Hearings Before the Senate Committee on Homeland Security and
Government Affairs, 111th Cong. (2009) (Testimony of Secretary Arne Duncan) at http://hsgac.senate.gov/public/
index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=cbe5331e-19ab-41d5-bffe-7610f97708f0.
114
“Preparing for the Flu: Department of Education Recommendations to Ensure the Continuity of Learning for
Schools(K-12) During Extended Student Absence or School Dismissal,” http://www.ed.gov/admins/lead/safety/
emergencyplan/pandemic/guidance/continuity-recs.pdf. CDC also has issued guidance for institutions of higher
(continued...)
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School closures may spawn numerous policy issues including when and how long schools should
be closed; how schools can comply with standardized testing requirements; and whether school
meals programs should continue. 115 However, school closures also raise legal issues. The main
question is who has the legal authority to institute a school closure. A CDC-requested study of
state legal authorities to close schools found that school closure is legally possible in most
jurisdictions during both routine and emergency situations.116 The study also indicated that state
authority for closure may be vested at various levels of government and in different departments,
generally the state or local education agencies or state or local departments of health. 117 However,
if there is a state or local declaration of emergency, the authority to close schools shifts to the
state emergency management agencies in most jurisdictions.118 These varying laws may create
legal controversies over who has the authority to make the school closure decision. In addition,
there could be legal challenges to whatever school closure decision is made, particularly if the
duration of a school closing is lengthy. Issues may also arise regarding whether school employees
will be paid for the time the schools are closed.119
Other legal issues regarding school closures may be raised under the Individuals with Disabilities
Education Act (IDEA). 120 IDEA requires that states receiving IDEA funding provide children with
disabilities a free appropriate public education (FAPE).121 Although IDEA does not specifically
address school closures due to a pandemic, the Department of Education has stated that schools
must be careful not to discriminate on the basis of disability when providing educational
services.122 ED noted that if schools are closed due to H1N1 and no educational services are
provided to any children, services do not have to be provided to children with disabilities.
However, if services are provided to the general student body, students with disabilities must have
(...continued)
education regarding responses to H1N1. Like the guidance for elementary and secondary schools, the higher education
guidance contains two main sets of recommendations: (1) recommendations which assume that H1N1 has a severity
similar to the spring/summer outbreak, and (2) recommendations to consider if the disease becomes more severe. These
recommendations parallel those for elementary and secondary school but also address issues relating to the close living
conditions experienced in college dormitories. “CDC Guidance for Responses to Influenza for Institutions of Higher
Education during the 2009-2010 Academic Year,” http://www.cdc.gov/h1n1flu/institutions/guidance/.
115
For a discussion of these issues and others see U.S. Department of Education, H1N1 Flu and U.S. Schools: Answers
to Frequently Asked Questions, http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/guidance/flu-faqs.pdf;
http://www.pandemicflu.gov/plan/school/index.html.
116
James G. Hodge, Jr., Dhrubajyoti Bhattacharya, and Jennifer Gray, “Legal Preparedness for School Closures in
Response to Pandemic Influenza and Other Emergencies,” http://www.pandemicflu.gov/plan/school/
schoolclosures.pdf. This study was summarized in James G. Hodge, Jr. “The Legal Landscape for School Closures in
Response to Pandemic Flu or Other Public Health Threats,” 7 Biosecurity and Bioterrorism: Biodefense Strategy,
Practice, and Science 45 (2009).
117
See James G. Hodge, Jr. “The Legal Landscape for School Closures in Response to Pandemic Flu or Other Public
Health Threats,” 7 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 45 (2009),
http://www.prepare.pitt.edu/pdf/school-closures.pdf.
118
Id. at 49. “The ability of departments of health and education in nonemergencies to close schools is largely
supplanted by the legal authority of state emergency management agencies during declared emergencies in 98% of the
jurisdictions studied.”
119
http://www.law.com/jsp/tx/PubArticleTX.jsp?id=1202430362015&slreturn=1.
120
20 U.S.C. §1400 et seq.
121
For a more detailed discussion of IDEA see CRS Report R40690, The Individuals with Disabilities Education Act
(IDEA): Statutory Provisions and Recent Legal Issues, by (name redacted).
122
“Guidance on Flexibility and Waivers for SEAs, LEAs, Postsecondary Institutions, and Other Grantee and Program
Participants,” http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/index.html.
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equal access to these opportunities.123 ED also observed that compensatory services may need to
be provided for a student with a disability in certain circumstances. 124
Vaccinations
Background125
Vaccination with a matched strain of influenza virus is considered the most effective measure to
prevent severe illness from flu. 126 Since influenza viruses continuously change, creating a
matched strain is not possible until a virus is circulating. The production of a vaccine is time
consuming, and the vaccine will become available in phases, not all at one time. When the
vaccine is first produced, it is likely that the demand for the H1N1 vaccine will be greater than
the supply.127 The first doses have become available but due to manufacturing issues, there is not
as much vaccine currently available as was anticipated. 128 It should be noted that a mass
vaccination campaign presents an array of challenges, including how to transport vaccines safely,
redistribute vaccines, track vaccinations, and monitor adverse effects.129
Vaccines may be mandated in some circumstances; however, except for the Department of
Defense and with respect to immigration, it is generally a matter of state, rather than federal,
authority. 130 The current federal plans for a possible pandemic flu vaccination campaign in the fall
assume that any such campaign would be voluntary.131
123
Id.
Id.
125
This section was written by (name redacted).
124
126
For a more detailed discussion of vaccine development, licensing, and use see CRS Report R40554, The 2009
Influenza Pandemic: An Overview, by (name redacted) and (name redacted).
127
http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/production_availability/
en/index.html. CDC has stated that “We do not expect that there will be a shortage of novel H1N1 vaccine, but flu
vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be
available in limited quantities.” “CDC Novel H1N1 Vaccination Planning Q&A,” http://www.cdc.gov/h1n1flu/
vaccination/statelocal/qa.htm.
128
http://www.cdc.gov/h1n1flu/vaccination/vaccinesupply.htm.
129
Trust for America’s Health, H1N1 Challenges Ahead, http://healthyamericans.org/reports/h1n1/
TFAH2009challengesahead.pdf.
130
CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws, by (name redacted); CRS
Report RL34708, Religious Exemptions for Mandatory Health Care Programs: A Legal Analysis, by Cynthia
Brougher; CRS Report R40570, Immigration Policies and Issues on Health-Related Grounds for Exclusion, by (name re
dacted) and (name redacted).
131
“With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally
flu-free summer months and some uncertainty about what the upcoming flu season might bring, CDC’s Advisory
Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1
vaccination effort to counter a possibly severe upcoming flu season.” CDC, Novel H1N1 Vaccination
Recommendations, at http://www.cdc.gov/h1n1flu/vaccination/acip.htm.
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The 2009 Influenza Pandemic: Selected Legal Issues
Allocation of Vaccines132
Overview
To implement the voluntary mass vaccination campaign, the federal government has purchased
the vaccine and a blended public- and private-sector distribution approach is being used.133 The
federal government provides guidance to the states and localities on how the vaccine should be
allocated but actual allocation decisions would be made at the state and local levels. CDC has
stated, however, that “State and local health departments are strongly encouraged to adhere to
national guidelines on vaccine prioritization. Uniformity in prioritizing vaccine is considered a
significant national interest. There may be instances where specific local needs should be taken
into consideration when implementing prioritization, but deviation from national guidelines
should be minimized.”134 States have generally been following this guidance. 135
Selected Federal Actions Prior to 2009
The federal government examined the issue of how to set priorities for scarce resources, including
vaccines, prior to the current H1N1 pandemic.136 The 2005 Homeland Security Council
Implementation Plan, 137 as supplemented by the two-year summary implementation plan,
required HHS with the Department of Homeland Security (DHS) to make priority
recommendations for access to pre-pandemic and pandemic influenza vaccines. 138 The
recommendations were to reflect the pandemic response goals as well as maintaining national
security. 139 On December 14, 2006, HHS issued a request for information (RFI) in the Federal
Register asking for “input on pandemic influenza vaccine prioritization considerations from all
interested and affected parties.”140 In addition, the RFI indicated that limiting transmission may
be an objective. The federal interagency working group used the input gained from this RFI to
issue draft guidance on October 17, 2007.141
After consideration of comments, HHS and the Department of Homeland Security issued final
guidance on July 23, 2008, in the form of a report entitled “Guidance on Allocating and Targeting
132
This section was written by (name redacted). It should be noted that allocation of other medical resources such as
hospital beds and medical equipment may be necessary in certain circumstances. For a discussion of these issues see
“Mass Medical Care with Scarce Resources,” http://www.ahrq.gov/prep/mmcessentials/; “State and Local Pandemic
Influenza Preparedness: Medical Surge,” http://oig.hhs.gov/oei/reports/oei-02-08-00210.pdf.
133
CDC, Clinician Outreach and Communication Activity (COCA), conference call on H1N1 vaccine, July 15, 2009,
transcript and presentation at http://emergency.cdc.gov/coca/callinfo.asp.
134
CDC Novel N1N1 Vaccination Planning Q & A, http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm.
135
For a state by state listing of vaccine priorities see http://www.astho.org/h1n1-vaccineprioritization.aspx.
136
For a detailed examination of the federal actions see CRS Report RL33381, The Americans with Disabilities Act
(ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name redacted).
137
National Strategy for Pandemic Influenza, November 2005, at http://www.flu.gov/plan/federal/index.html#national.
138
Id. “Implementation Plan Two Year Summary” Section 6.1.14.1.
139
Id. These goals are reducing health, societal, and economic impacts and maintaining national and homeland security,
and public values.
140
71 Fed.Reg. 75252 (December 14, 2006).
141
“Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine,” http://www.pandemicflu.gov/vaccine/
prioritization.html.
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Pandemic Influenza Vaccine.”142 The guidance creates tiers for coverage, and varies the
vaccination priority depending on the severity of the pandemic. Since pandemics that have higher
case fatality rates are more likely to disrupt essential services, threaten public order and homeland
security, and disrupt supply chains, individuals who are necessary for these functions would
receive a higher priority in a severe pandemic. Conversely, individuals with high-risk conditions
making them more vulnerable to serious illness would receive greater priority in a less severe
pandemic. 143 The guidance gives its highest rank to deployed forces, critical health care workers,
fire and police, and pregnant women, infants, and toddlers. The importance of maintaining
homeland and national security is highlighted and the guidance recognizes the following
objectives as the most important:
•
protecting those who are essential to the pandemic response and providing care
for persons who are ill,
•
protecting those who maintain essential community services,
•
protecting children, and
•
protecting workers who are at greater risk of infection due to their job.144
However, the guidance also recognizes that the plans must be flexible because “the guidance may
be modified based on the status of vaccine technology, the characteristics of pandemic illness, and
risk groups for severe disease—factors that will remain unknown until a pandemic actually
occurs.”145
Federal Actions After Emergence of Influenza A(H1N1)
On July 8, 2009, CDC issued recommendations for state and local planning for a pandemic flu
vaccination program.146 These recommendations again emphasized that changing data may
change the target populations.147 The CDC recommendations noted that immunization of military
forces may be appropriate given the current circumstances but did not address the military in its
allocation discussion. The CDC focused only on the vaccination of civilian populations under the
authority of CDC and state and local health departments.148
142
U.S. Department of Health and Human Services, U.S. Department of Homeland Security, “Guidance on Allocating
and Targeting Pandemic Influenza Vaccine,” (July 23, 2008) http://www.hhs.gov/news/press/2008pres/07/
20080723a.html.
143
Id. at 10-11.
144
Id. at 3.
145
Id. at 1.
146
http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm.
147
CDC recommended the following groups be targeted first for vaccines: students and staff associated with schools
and children at or over six months and staff in child care centers (vaccinated at schools and child care centers);
pregnant women, children six months to four years old, new parents and household contacts of children (vaccinated at
providers’ offices and community clinics); adults under 65 years old with medical conditions that increase the risk of
complications from flu (vaccinated at work settings, community clinics, pharmacies, providers’ offices); and health
care workers and emergency services sectors personnel (vaccinated at work settings, providers’ offices).
http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm.
148
http://www.cdc.gov/h1n1flu/vaccination/statelocal/planning.htm.
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On July 29, 2009, the CDC’s Advisory Committee on Immunization Practices (ACIP) met to
make recommendations on H1N1 vaccine priorities. The ACIP recommendations generally track
those issued on July 8 by CDC for planning purposes and list the following target groups:
•
pregnant women,
•
household and caregiver contacts of children younger than 6 months of age (e.g.,
parents, siblings, and daycare providers),
•
health care and emergency medical services personnel,
•
persons from 6 months through 24 years of age, and
•
persons aged 25 through 64 years who have medical conditions associated with a
higher risk of influenza complications.149
The groups recommended for priority vaccination by the ACIP total approximately 159 million
people in the United States.150 If there is a shortage of vaccine, the ACIP recommends that the
following groups receive the vaccine first:
•
pregnant women,
•
people who live with or care for children younger than six months of age,
•
health care and emergency services personnel with direct patient contact,
•
children six months through four years old, and
•
children 5 through 18 years old who have chronic medical conditions.151
During the press briefing, the ACIP noted that it recommends that 83% of the population be
vaccinated for seasonal influenza, but less than 40% are actually vaccinated each year. The
demand for the H1N1 vaccine is uncertain because not everyone who is in a priority group may
choose to get the vaccine. Hence, with more vaccine potentially available to lower tiers in the
priority groupings, ACIP noted in the press briefing that it may be possible that the more limited
target groups might not be used. 152 Similarly, CDC stated that a vaccine shortage is not expected;
however, availability and demand are unpredictable, thus it is possible that priority groups may be
needed. 153 CDC observed that the ACIP recommendations “leave room for flexibility at the local
level depending on the local vaccine supply situation.”154 As the vaccination campaign has begun,
CDC emphasizes that the state and local providers “should be aware of and follow any additional
guidance provided by their state or local health departments. If no additional guidance is provided
at the state or local level, providers should vaccinate among the initial target group populations on
a first come, first served basis.”155
149
http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm.
Id.
151
http://www.cdc.gov/media/pressrel/2009/r090729b.htm.
152
http://www.cdc.gov/media/transcripts/2009/t090729b.htm.
153
http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm.
154
Id.
155
http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm.
150
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Legal Issues
The allocation of scarce pandemic vaccine could raise several legal issues. If an individual has an
adverse response to the vaccine, there may be liability issues. However, HHS Secretary Kathleen
Sebelius issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP
Act)156 that waives vaccine liability, except for willful misconduct, for the United States, and for
manufacturers; distributors; program planners; persons who prescribe, administer, or dispense the
countermeasure; and employees of any of the above. This declaration would also make funds
available under a vaccine compensation fund.157
Constitutional due process and equal protection issues as well as civil rights issues might also be
raised concerning vaccine allocation if a particular covered group was adversely impacted by the
vaccine allocation plan. 158 More specifically, issues regarding the Americans with Disabilities Act
(ADA) 159 could be raised. However, vaccine allocation plans that are based on a determination
that an individual not receive a vaccine because the vaccine would not be effective given his or
her health situation would be unlikely to raise ADA concerns, because the determination would
be based on a medical determination of treatment. Similarly, the mere fact that a decision would
have a disparate impact on individuals with disabilities would not necessarily be sufficient to
violate the nondiscrimination mandates.160
Other potential legal issues could arise concerning state and local decisions about vaccine
allocation. Questions may occur about defining subgroups within priority groups. For example,
how is a “health care worker” to be defined? Once the groups are defined, issues may arise
concerning how vaccination sites will ensure that individuals are within the priority group. For
example, would an individual have to “prove” that he or she had a medical condition that
increased risk from the flu?161 What form would this proof have to take? Would there be potential
liability issues for health care providers if they do not follow guidance concerning who is to be
vaccinated? Would vaccinations be provided for illegal aliens who are within the priority groups?
Finally, if there is possible liability for individuals or state or local agencies making these
decisions, should there be any legal protections available to limit liability?
The CDC “H1N1 Clinicians Questions and Answers” provides guidance for a vaccination
provider who is faced with requests for vaccination from individuals not in the initial target
group. CDC notes that some providers may have enough doses of vaccine to meet the demand
from all patients but, if this is not the case, “the provider may wish to explain their local plan and
rationale for vaccination among the initial target groups and ask others to wait to get vaccinated
later.” CDC emphasized that “the decision regarding who should get vaccinated is one that should
156
42 U.S.C. § 247d-6d, 247d-6e.
For a more detailed discussion of this issue see the subsequent discussion of the PREP Act, and CRS Report
RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by (name redacted) and (name re
dacted).
158
For a more detailed discussion see the subsequent discussion civil rights issues and CRS Report RL33381, The
Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by (name reda
cted).
159
42 U.S.C. §12101 et seq.
160
Alexander v. Choate, 469 U.S. 287 (1985).
157
161
CDC states that “[t]here will be no federal requirements for vaccinators to require documentation of priority group
status such as doctor’s note documenting pregnancy or risk status.” http://www.cdc.gov/h1n1flu/vaccination/statelocal/
qa.htm.
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be made between the provider and the patient, weighing whether there are sufficient doses
available for those at greatest risk for infection and serious complications as well as the likelihood
that patients turned away will come back for vaccine at a later date.”162 This guidance places the
decision between the provider and the patient. It does not directly address the potential liability
issue for a provider when an individual who was in a priority group is unable to get vaccinated
because of the vaccination of individuals not in the priority group, and this priority group
individual suffers adverse consequences due to the lack of timely vaccination. However, a
provider who weighs the factors suggested by CDC and makes an individualized determination,
most likely would not be found liable to another individual who was unable to obtain vaccination.
In addition, the burden of proof for the plaintiff in this scenario would be a difficult one.
Mandatory Vaccinations163
History and Precedent
Historically, the preservation of the public health has been the primary responsibility of state and
local governments, and the authority to enact laws relevant to the protection of the public health
derives from the state’s general police powers.164 With respect to the preservation of the public
health in cases of communicable disease outbreaks, these powers may include the enactment of
mandatory vaccination laws. 165 Every state has a law requiring children to be vaccinated before
they enroll in a public or private school.166 All states also allow medical exemptions from school
vaccination requirements for those whose immune systems are compromised, who are allergic to
vaccines, or have other medical contraindications to vaccines, and many states also provide
exemptions for religious or philosophical reasons.167 Various state laws also require vaccination
against hepatitis B and meningococcal disease for incoming college and university students.168
Jacobson v. Massachusetts169 is the seminal case regarding a state’s or municipality’s authority to
institute a mandatory vaccination program as an exercise of its police powers. In Jacobson, the
Supreme Court upheld a Massachusetts law that gave municipal boards of health the authority to
require the vaccination of persons over the age of 21 against smallpox, and determined that the
vaccination program instituted in the City of Cambridge had “a real and substantial relation to the
protection of the public health and safety.”170 In upholding the law, the Court noted that “the
162
http://www.cdc.gov/h1n1flu/vaccination/clinicians_qa.htm.
This section was written by (name redacted), Legislative Attorney. For a detailed discussion
see CRS Report
RS21414, Mandatory Vaccinations: Precedent and Current Laws, by (name redacted).
164
See The People v. Robertson, 134 N.E. 815, 817 (1922).
165
Starting with the smallpox vaccine, vaccines have been used to halt the spread of disease for over 200 years. Donald
A. Henderson & Bernard Moss, Smallpox and Vaccinia, VACCINES 74, 75 (Stanley A. Plotkin & Walter A. Orenstein
eds., 3d ed. 1999).
166
For a more detailed discussion of these issues see CRS Report RS21414, Mandatory Vaccinations: Precedent and
Current Laws, by (name redacted).
167
National Conference of State Legislatures, States with Religious and Philosophical Exemptions from School
Immunization Requirements, updated June, 2009, at http://www.ncsl.org/Default.aspx?TabId=14376.
168
See the Immunization Action Coalition website state charts at http://www.immunize.org/laws/hepbcollege.asp and
http://www.immunize.org/laws/menin.asp.
169
197 U.S. 11 (1905).
170
Id. at 31. The Massachusetts statute in question read as follows: “Boards of health, if in their opinion it is necessary
for public health or safety, shall require and enforce the vaccination and revaccination of all the inhabitants of their
(continued...)
163
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police power of a State must be held to embrace, at least, such reasonable regulations established
directly by legislative enactment as will protect the public health and the public safety.”171 The
Court added that such laws were within the full discretion of the state, and that federal powers
with respect to such laws extended only to ensure that the state laws did not “contravene the
Constitution of the United States or infringe any right granted or secured by that instrument.”172
In the context of the current H1N1 pandemic, mandatory vaccination issues are less likely to arise
than allocation issues, since it is unlikely that there would be sufficient vaccine available to
vaccinate the entire population, particularly in the early stages of vaccine availability. 173
Health Care Workers and Mandatory Vaccinations
A number of states have laws requiring employees of certain health care facilities, such as nursing
homes, to be vaccinated against diseases such as measles, mumps and rubella. Such laws, which
vary widely, generally contain opt-out provisions where a vaccine is medically contraindicated or
if the vaccine is against the individual’s religious or philosophical beliefs.174 A few states have
laws pertaining to influenza vaccination of health care workers, and most that do provide for
voluntary influenza immunization programs and staff education measures for employees;
however, a few states have mandatory requirements for influenza vaccinations for health care
workers.175 For example, Alabama has a law requiring that employees of nursing homes receive
an annual vaccination against the influenza virus, unless the vaccine is medically contraindicated,
or the vaccine is against the individual’s religious beliefs, or if the individual refuses the vaccine
after being fully informed of the health risks of not being immunized. 176
In August 2009, the New York State Health Department amended its regulations to require that
health care workers at hospitals, in home health care agencies, and in hospice care be immunized
against influenza viruses as a precondition to employment and on an annual basis.177 This
regulation, issued on an emergency basis, did not permit any exceptions to the influenza
vaccination mandate except for medical contraindications. Lawsuits were filed challenging the
regulation’s validity, and on October 16, 2009, a state judge issued a temporary restraining order
suspending its application to New York health care workers.178 However, on October 22, 2009,
(...continued)
towns, and shall provide them with the means of free vaccination. Whoever refuses or neglects to comply with such
requirement shall forfeit five dollars.” M.G.L.A. c. 111, § 181 (2004).
171
Id. at 25.
172
Id.
173
For a discussion of issues raised by the allocation of vaccine see preceding section of this report, “Allocation of
Vaccines,” and CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical
Resources During a Pandemic, by (name redacted).
174
Lindley, Megan C. et al., Assessing State Immunization Requirements for Healthcare Workers and Patients, Am J
Prev Med 2007;32(6): 459-465.
175
The CDC maintains a continuously updated online database of state laws pertaining to vaccination requirements at
http://www.cdc.gov/vaccines/vac-gen/laws/state-reqs.htm.
176
ALA. CODE § 22-21-10.
177
This regulation could apply to the influenza A(H1N1) virus if a vaccine becomes available in sufficient supply. The
text of the regulation may be viewed at http://www.health.state.ny.us/regulations/emergency/. See also a press release
issued by New York State Health Commissioner Richard F. Daines at http://www.health.state.ny.us/press/releases/
2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm.
178
The temporary restraining order issued by state Supreme Court Judge Thomas J. McNamara, may be accessed at
http://op.bna.com/hl.nsf/r?Open=sfak-7wvsxh. This order requires the parties to return to court for a hearing on
(continued...)
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The 2009 Influenza Pandemic: Selected Legal Issues
Governor David A. Paterson announced the suspension of the flu shot mandate for health care
employees due to the current shortage of both the seasonal flu vaccine and the influenza A(H1N1)
vaccine.179
In the private sector, employers can require health care workers to be vaccinated against
communicable diseases as a condition of employment, unless a state law applies which permits
employees to opt out. 180 Virginia Mason Medical Center in Seattle, WA, became the first hospital
in the nation, in 2004, to make vaccination a condition of employment for all its employees.
Within three years, the hospital reported 98% staff coverage, except for 2% of the staff who
refused for medical or religious reasons, and, because of their refusal, were required to wear
surgical masks when in the hospital. 181
In 2008, the Department of Defense (DOD) issued a policy directive requiring “all civilian health
care personnel who provide direct patient care in DoD military treatment facilities to be
immunized against seasonal influenza infection each year as a condition of employment, unless
there is a documented medical or religious reason not to be immunized.”182
Vaccination Orders During a Public Health Emergency
Many states also have laws providing for mandatory vaccinations during a public health
emergency or outbreak of a communicable disease.183 Generally, the power to order such actions
rests with the governor of the state or with a state health officer. For example, a governor may
have the power to supplement the state’s existing compulsory vaccination programs and institute
additional programs in the event of a civil defense emergency period.184 Or, a state health officer
may, upon declaration of a public health emergency, order an individual to be vaccinated “for
communicable diseases that have significant morbidity or mortality and present a severe danger
to public health.”185 In addition, exemptions are generally provided for medical reasons or where
(...continued)
October 30, 2009.
179
See press release at http://www.ny.gov/governor/press/press_1022094.html.
180
See Vaccination of Healthcare Workers for H1N1 and Other Communicable Diseases, American Federation of
Teachers, Frequently Asked Questions, at http://www.aft.org/healthcare/download/FAQ%20-%20H1N1.pdf. This FAQ
notes that the Joint Commission requires accredited organizations to offer influenza vaccinations to staff, including
those with close patient contact, as a condition of accreditation.
181
Manning, Anita., Hospitals Shoot for Employees to Get Flu Vaccine, September 16, 2007, at
http://www.usatoday.com/news/health/2007-09-16-flu-doctors_N.htm. A union dispute regarding the flu shot mandate
resulted in an exemption for union employees, but all other hospital employees are covered.
182
Department of Defense/Joint Forces, HA Policy: 08-005, Policy for Mandatory Seasonal Influenza Immunization
for Civilian Health Care Personnel Who Provide Direct Patient Care in Department of Defense Military Treatment
Facilities, April 4, 2008, available at http://mhs.osd.mil/Content/docs/pdfs/policies/2008/08-005.pdf.
183
Following the then-Acting HHS Secretary’s public health emergency declaration on April 26, 2009, a number of
states issued their own statewide or territorial emergency declarations relating to the H1N1 influenza outbreak. See the
continuously updated list of such states and territories at http://www.astho.org/h1n1-emergency.aspx.
184
HAW. REV. STAT. § 128-8 (2008). In Arizona, the Governor, during a state of emergency or state of war emergency
in which there is an occurrence or the imminent threat of smallpox or other highly contagious and highly fatal disease,
may “issue orders that mandate treatment or vaccination of persons who are diagnosed with illness resulting from
exposure or who are reasonably believed to have been exposed or who may reasonably be expected to be exposed.”
ARIZ. REV. STAT. § 36-787 (2009).
185
FLA. STAT. § 381.00315 (2008).
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The 2009 Influenza Pandemic: Selected Legal Issues
objections are based on religion or conscience.186 However, if a person refuses to be vaccinated,
he or she may be quarantined during the public health emergency giving rise to the vaccination
order. The legality of a particular mandatory vaccination program will hinge upon balancing the
severity of the public health emergency with the effectiveness and safety of the vaccine involved,
and the availability of less intrusive methods of dealing with the situation. For example, dealing
with the introduction of smallpox by a terrorist might involve the use of national security powers
and involve some consequential restrictions on individual civil liberties. However, most programs
for protecting the public health also recognize and protect constitutional rights to personal
liberties, such as freedom from physical restraint, bodily invasion, or the right to refuse medical
treatment.187
Model State Emergency Health Powers Act
In addition to the current laws, many states have considered and have passed some or all of the
provisions set forth in the Model State Emergency Health Powers Act (Model Act).188 The Model
Act was drafted by The Center for Law and the Public’s Health at Georgetown and Johns
Hopkins Universities. 189 It seeks to “grant public health powers to state and local public health
authorities to ensure strong, effective, and timely planning, prevention, and response mechanisms
to public health emergencies (including bioterrorism) while also respecting individual rights.”
With respect to vaccinations, the Model Act includes provisions similar to the current laws
discussed above. Under the Model Act, during a public health emergency, the appropriate public
health authority would be authorized to “vaccinate persons as protection against infectious
disease and to prevent the spread of contagious or possibly contagious disease.” The Model Act
requires that the vaccine be administered by a qualified person authorized by the public health
authority, and that the vaccine “not be such as is reasonably likely to lead to serious harm to the
affected individual.” The Model Act recognizes that individuals may be unable or unwilling to
undergo vaccination “for reasons of health, religion, or conscience,” and provides that such
individuals may be subject to quarantine to prevent the spread of a contagious or possibly
contagious disease. 190
Role of the Federal Government
Federal jurisdiction over public health matters derives from the Commerce Clause, which states
that Congress shall have the power “[t]o regulate Commerce with foreign Nations, and among the
186
See, eg., CONN. GEN. STAT. § 19a-222 (2009) (exemption for physician’s determination of sickness); VA. CODE ANN.
§ 32.1-48 (2009) (vaccination waived if detrimental to person’s health, as certified by a physician); WIS. STAT. §
252.041 (2008) (vaccination may be refused for reasons of religion or conscience). See also, CRS Report RL34708,
Religious Exemptions for Mandatory Health Care Programs: A Legal Analysis, by Cynthia Brougher.
187
Mariner, Wendy K. et al., Jacobson v Massachusetts: It’s Not Your Great-Great-Grandfather’s Public Health Law,
AM J PUB HEALTH, 2005;95(4):581-90.
188
The Center for Law and the Public’s Health tracks state legislative activity relating to the Model Act at
http://www.publichealthlaw.net/Resources/Modellaws.htm#MSEHPA. According to James G. Hodge Jr., Executive
Director of the Center for Law and the Public’s Health, 44 states have introduced legislation based on the Model Act
and 38 states have adopted some parts of it. Marcia Coyle, “Legal Issues Swell If Swine Flu Spreads,” The National
Law Journal (May 4, 2009), available at http://law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202430383777&
Legal_Issues_Swell_If_Swine_Flu_Spreads&slreturn=1
189
The text of the Center’s Model State Emergency Health Powers Act from 2001 is available at
http://www.publichealthlaw.net/ModelLaws/index.php.
190
Id. See Section 604 of the Model Act for provisions relating to quarantine.
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The 2009 Influenza Pandemic: Selected Legal Issues
several States.”191 Thus, under the Public Health Service Act, the Secretary of Health and Human
Services has authority to make and enforce regulations necessary “to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries into the States or
possessions, or from one State or possession into any other State or possession.”192 With regard to
foreign countries, the Secretary has the power to restrict the entry of groups of aliens for public
health reasons.193 This power includes the authority to issue vaccination requirements for
immigrants seeking entry into the United States.194 With regard to interstate commerce, the Public
Health Service Act deals primarily with the use of quarantine measures to halt the spread of
certain communicable diseases.195 The Public Health Service Act does not specifically authorize
any mandatory vaccination programs; nor do there appear to be any regulations regarding the
implementation of a mandatory vaccination program at the federal level during a public health
emergency.
As noted above, state and local governments have the primary responsibility for protecting the
public health, and this has been reflected in the enactment of the various state laws authorizing
mandatory vaccination procedures during a public health emergency. Any federal civilian
mandatory vaccination program applicable to the general public would likely be limited to areas
of existing federal jurisdiction, i.e., interstate and foreign commerce, similar to the federal
quarantine authority. 196 Aliens seeking admission to the United States, for example, are already
required to show proof of required vaccinations.197 This limitation on federal jurisdiction
acknowledges that states have the primary responsibility for protecting the public health, but that
under certain circumstances, federal intervention may be necessary.
Civil Rights198
Introduction
Infectious diseases, such as the 2009 influenza pandemic, may raise a classic civil rights issue: to
what extent can an individual’s liberty be curtailed to advance the common good?199 The United
191
U.S. CONST. art. I, § 8.
42 U.S.C. 264(a). Originally, the statute conferred this authority on the Surgeon General; however, pursuant to
Reorganization Plan No. 3 of 1966, all statutory powers and functions of the Surgeon General were transferred to the
Secretary.
193
8 U.S.C. § 1182.
194
Currently, vaccines recommended by the Advisory Committee on Immunization Practices for the general U.S.
population are also required for immigrants who seek permanent residence in the United States, and people currently
living in the United States who seek to adjust their status to become permanent residents. See the CDC Division of
Global Migration and Quarantine website for information on vaccination requirements for immigrants at
http://www.cdc.gov/ncidod/dq/diseases.htm#vaccine, and a recent CDC Federal Register notice seeking comment,
“Criteria for Vaccination Requirements for U.S. Immigration Purposes,” 74 Fed. Reg. 15986 (April 8, 2009). For
further information about health-related grounds for exclusion of immigrants see CRS Report R40570, Immigration
Policies and Issues on Health-Related Grounds for Exclusion, by (name redacted) and (name redacted).
195
See 42 C.F.R. Parts 70 (interstate matters) and 71 (foreign arrivals).
196
It has been suggested that in the case of a serious outbreak of a communicable disease, the federal government
might enact policies to encourage vaccinations or place restrictions on those who refuse. Bureau of Justice Assistance,
U.S. Department of Justice, The Role of Law Enforcement in Public Health Emergencies, September, 2006 at 19.
197
8 U.S.C. § 1182(a)(1)(A).
198
This section was written by (name redacted), Legislative Attorney.
192
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The 2009 Influenza Pandemic: Selected Legal Issues
States Constitution and federal civil rights laws provide for individual due process and equal
protection rights as well as a right to privacy, but these rights are balanced against the needs of
the community. With the advance of medical treatments in recent years, especially the use of
antibiotics, the civil rights of the individual with a contagious disease have been emphasized.
However, classic public health measures such as quarantine, isolation, and contact tracing are,
nevertheless, available in appropriate situations and, as new or resurgent diseases have become
less treatable, some of these classic public health measures have been increasingly used.
Therefore, the issue of how to balance these various interests in a modern culture that is sensitive
to issues of individual rights has become critical.200
Constitutional Rights to Due Process and Equal Protection
Constitutional rights to due process and equal protection may be implicated by the imposition of a
quarantine or isolation order.201 The Fifth and Fourteenth Amendments prohibit governments at
all levels from depriving individuals of any constitutionally protected liberty interest without due
process of law. What process may be due under certain circumstances is generally determined by
balancing the individual’s interest at stake against the governmental interest served by the
restraints, determining whether the measures are reasonably calculated to achieve the
government’s aims,202 and deciding whether the least restrictive means have been employed to
further that interest.
(...continued)
199
For a discussion of balancing individual legal rights and responsibility and communal objectives, see Institute of
Medicine, Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations (September 2009).
200
For a detailed discussion of constitutional issues relating to quarantine see Michelle A. Daubert, “Pandemic Fears
and Contemporary Quarantine: Protecting Liberty Through a Continuum of Due Process Rights,” 54 BUFFALO L. REV.
1299 (January 2007). For an analysis of how to balance the sometimes competing interests of personal and economic
liberties with the public’s health and security see Lawrence O. Gostin, “When Terrorism Threatens Health: How Far
are Limitations on Personal and Economic Liberties Justified?” 55 Fla. Law Rev. 1105 (December 2003). See also
David P. Fidler, Lawrence O. Gostin, and Howard Markel, “Through the Quarantine Looking Glass: Drug-Resistant
Tuberculosis and Public Health Governance, Law and Ethics,” 35 J. OF LAW, MEDICINE & ETHICS 616 (2007), where
the authors note that courts have set four limits on isolation and quarantine authority: the subject must actually be
infectious or have been exposed to infectious disease, the subject must be placed in a safe and habitable environment,
the authority must be exercised in a non-discriminatory manner, and there must be procedural due process.
201
It has been argued that the federal quarantine authority may not pass constitutional muster since it does not
specifically provide for a right to a fair hearing. See Howard Markel, Lawrence O. Gostin, and David P. Fidler,
“Extensively Drug-Resistant Tuberculosis: An Isolation Order, Public Health Powers, and a Global Crisis,” 298 JAMA
83-84 (July 4, 2007). It should be noted that the proposed CDC quarantine regulations contain detailed due process
procedures including a right to a hearing for full quarantine. 70 Fed. Reg. 71,892 (November 30, 2005),
http://www.cdc.gov/ncidod/dq/nprm/. However, these proposed regulations have been strongly criticized for what
commentators have described as constitutional failings. These criticisms have highlighted the lack of independent
judicial review for individuals subject to quarantine, the broad discretion accorded to directors of federal quarantine
stations, the lack of hearings during provisional quarantine, and privacy concerns. See, e.g., Lawrence O. Gostin,
Benjamin E. Berkman, and David P. Fidler, Comments on Department of Health and Human Services, Control of
Communicable Diseases (Proposed Rule), 42 C.F.R. Parts 70 and 71 (November 30, 2005),
http://www.publichealthlaw.net/Resources/BTlaw.htm; The New England Coalition for Law and Public Health,
Comments on the Interstate and Foreign Quarantine Regulations Proposed by the Centers for Disease Control and
Prevention, http://64.233.169.104/u/UMBaltimore?q=cache:fsSm0xxCULQJ:www.umaryland.edu/healthsecurity/docs/
New%2520England%2520Coalition%2520Comments%2520CDC%2520revisions.pdf+%22new+england+coalition+fo
r+law+and+public+health%22&hl=en&ct=clnk&cd=1&gl=us&ie=UTF-8; Felice Batlan, “Law in the Time of Cholera:
Disease, State Power, and Quarantines Past and Future,” 80 TEMP. L. REV. 53 (2007).
202
See, e.g., Jacobson v. Massachusetts, 197 U.S. 11, 27 (1905) (enforcement of public health laws must have some
“real or substantial relation to the protection of the public health and the public safety”); Jew Ho v. Williamson, 103 F.
(continued...)
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The 2009 Influenza Pandemic: Selected Legal Issues
In O’Connor v. Donaldson,203 the Supreme Court examined the civil commitment of an individual
to a mental hospital and held that “a State cannot constitutionally confine without more, a
nondangerous individual who is capable of surviving safely in freedom by himself or with the
help of willing and responsible family members or friends.”204 Arguably, an individual who is
highly contagious with a serious illness may be considered dangerous, and thus subject to
involuntary confinement if there is no less restrictive alternative. The lesson of Donaldson is that
such confinements must be carefully examined in order to comport with the constitutional right to
due process. Donaldson also raises the issue of whether less restrictive programs are required
prior to the imposition of the more restrictive application of isolation or quarantine. It could be
argued that the least restrictive alternative must first be applied or more restrictive alternatives
will run afoul of constitutional requirements.205
The unequal treatment of certain socially disfavored groups with regard to quarantine also raises
equal protection issues. For example, in Wong Wai v. Williamson206 a board of health resolution
mandated Chinese residents to be quarantined for bubonic plague unless they submitted to
inoculation with a serum with “the only justification offered for this discrimination ... a
suggestion ... that this particular race is more liable to the plague than any other.”207 The court
struck the resolution as a violation of the equal protection clause.208
Although the Constitution does not specifically grant a right to travel, the Supreme Court has held
that there is a fundamental right to travel.209 This right, and the applicable due process procedures,
have been examined in the context of transportation security, particularly regarding alleged
terrorists.210 Generally, restrictions on travel, such as identification policies for boarding
airplanes, have not been found to violate the Constitution.211 If the public safety arguments have
(...continued)
10 (C.C.N.D. Cal. 1900) (quarantine of San Francisco district inhabited primarily by Chinese immigrants purportedly
to control the spread of bubonic plague was invalidated).
203
422 U.S. 563 (1975).
204
Id. at 576.
205
See Wendy D. Parmet, “Legal Power and Legal Rights—Isolation and Quarantine in the Case of Drug-Resistant
Tuberculosis,” 357 NEW ENG. J. OF MEDICINE 433, 435 (August 2, 2007). Professor Parmet argues that compulsory
measures are not the most effective and may prompt individuals who may be subject to them to evade authorities. “By
ensuring that coercion is used only when less restrictive alternatives will not work and with due regard for the rights of
those detained, the law can foster public trust, minimizing the need for compulsion and laying the groundwork for the
comprehensive and costly control programs needed to prevent the spread of XDR tuberculosis and other contagious
pathogens.” Id.
206
103 F. 1 (N.D. Cal. 1900).
207
Id. at 15.
208
One commentator observed that it is unlikely that such blatantly discriminatory actions would occur today, but noted
that “studies of New York City’s use of isolation orders for tuberculosis in the 1990s show that more than 90% of the
people detained were non-white and more than 60% were homeless.... Although these figures may reflect the
democracy (sic) of non-compliant patients with tuberculosis in New York City at that time, the fact that the most potent
public health tool was used primarily against marginalized, nonwhite persons underscores the need for legal
oversight—if only so that affected communities can be assured of the absence of discrimination.” Wendy D. Parmet,
“Legal Power and Legal Rights—Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis,” 357 NEW ENG.
J. OF MEDICINE 433, 434 (August 2, 2007).
209
United States v. Guest, 383 U.S. 745 (1966); Shapiro v. Thompson, 394 U.S. 618 (1969).
210
See CRS Report RL32664, Interstate Travel: Constitutional Challenges to the Identification Requirement and Other
Transportation Security Regulations, by (name redacted); Justin Florence, “Making the No Fly List Fly: A Due
Process Model for Terrorist Watchlists,” 115 Yale L.J. 2148 (2006).
211
See Gilmore v. Gonzales, 435 F.3d 1125 (9th Cir. 2006), cert. den. 549 U.S. 1110 (2007). “We reject Gilmore’s
(continued...)
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The 2009 Influenza Pandemic: Selected Legal Issues
prevailed regarding restrictions due to transportation security, they would be likely to prevail
against a serious public health threat. However, the seriousness of the threat and the due process
procedures used would be key to any constitutional determination.
Federal Nondiscrimination Laws
In addition to constitutional issues, discrimination against an individual with an infectious disease
may be covered by certain federal laws, notably Section 504 of the Rehabilitation Act,212 the
Americans with Disabilities Act (ADA),213 and the Air Carrier Access Act (ACAA). 214 However,
under these statutes, an individual with a contagious disease does not have to be given access to a
place of public accommodation or employment if such access would place other individuals at a
significant risk.215
Section 504 of the Rehabilitation Act
Although the language of Section 504 does not specifically discuss contagious diseases, the
Supreme Court dealt with discrimination issues in the context of tuberculosis and Section 504 in
School Board of Nassau County v. Arline.216 The Court found that in most cases an individualized
inquiry is necessary in order to protect individuals with disabilities from “deprivation based on
prejudice, stereotypes, or unfounded fear, while giving appropriate weight to such legitimate
concerns of grantees as avoiding exposing others to significant health and safety risks.”217 The
Court adopted the test enunciated by the American Medical Association amicus brief and held
that the factors which must be considered include “findings of facts, based on reasonable medical
judgments given the state of medical knowledge, about (a) the nature of the risk (how the disease
is transmitted), (b) the duration of the risk (how long is the carrier infectious), (c) the severity of
the risk (what is the potential harm to third parties) and (d) the probabilities the disease will be
transmitted and will cause varying degrees of harm.” The Court also emphasized that courts
“normally should defer to the reasonable medical judgments of public health officials.”218
(...continued)
rights to travel argument because the Constitution does not guarantee the right to travel by any particular form of
transportation.” 435 F.3d 1125, 1136(9th Cir. 2006).
212
29 U.S.C. §794. For a more detailed discussion of Section 504 generally see CRS Report RL34041, Section 504 of
the Rehabilitation Act of 1973: Prohibiting Discrimination Against Individuals with Disabilities in Programs or
Activities Receiving Federal Assistance, by (name redacted).
213
42 U.S.C. §§12101 et seq. For a more detailed discussion of the ADA generally see CRS Report 98-921, The
Americans with Disabilities Act (ADA): Statutory Language and Recent Issues, by (name redacted). The ADA was
recently amended by the ADA Amendments Act, P.L. 110-325, which rejects certain Supreme Court interpretations of
the definition of disability and generally increases the likelihood that an individual will fall within the coverage of the
definition. For a more detailed discussion of these amendments see CRS Report RL34691, The ADA Amendments Act:
P.L. 110-325, by (name redacted).
214
42 U.S.C. §1374(c). For a more detailed discussion of the ACAA generally see CRS Report RL34047, Overview of
the Air Carrier Access Act, by (name redacted).
215
For a more detailed discussion of this issue in the ADA context see CRS Report RS22219, The Americans with
Disabilities Act (ADA) Coverage of Contagious Diseases, by (name redacted).
216
480 U.S. 273 (1987).
217
Id. at 287.
218
Id. at 288. These standards are incorporated into the regulations for the Air Carrier Access Act at 14 C.F.R. §382.51.
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The 2009 Influenza Pandemic: Selected Legal Issues
The Americans With Disabilities Act (ADA)
The Americans with Disabilities Act (ADA) is a broad civil rights act prohibiting discrimination
against individuals with disabilities.219 Four main issues are raised under the ADA by the H1N1
pandemic: whether an individual infected with the H1N1 virus is an individual with a disability;
to what extent can an employer make possibly disability related inquiries; what are the
requirements for reasonable accommodation; and to what extent does the ADA “direct threat”
language allow certain actions.
Individual with a Disability
The ADA Amendments Act defines the term disability with respect to an individual as “(A) a
physical or mental impairment that substantially limits one or more of the major life activities of
such individual; (B) a record of such an impairment; or (C) being regarded as having such an
impairment (as described in paragraph (3)).”220 Whether an individual infected with the H1N1
virus is an individual with a disability is a fact-specific inquiry but the EEOC indicates that if the
illness is similar to seasonal influenza, it would not be a disability. 221
Disability-Related Inquiries
Generally, the ADA prohibits an employer from making disability-related inquiries except in
certain limited situations. 222 An employer may attempt to plan for absences during a pandemic by
making inquiries about an employee. The EEOC has stated that an employer may not ask an
individual if he or she has a chronic health condition that would make the employee more
susceptible to influenza complications, unless there is evidence of a direct threat.223 However, an
employer may use a survey to identify which employees may not be available for work if the
survey includes questions not only about chronic health conditions but also about the need to care
for a child or take public transportation.224
Reasonable Accommodation
The ADA prohibits discrimination against an individual with a disability and requires the
provision of reasonable accommodations to the individual’s disability unless it imposes an undue
hardship on an employer.225 During a pandemic, reasonable accommodations continue to be
required. For example, if an individual with low vision requires a screen reader at work, this must
219
42 U.S.C. §§12101 et seq. For a more detailed discussion of the ADA, see CRS Report 98-921, The Americans with
Disabilities Act (ADA): Statutory Language and Recent Issues, by (name redacted). For a more detailed discussion of
the ADA and employment issues raised by a pandemic see CRS Report R40866, The Americans with Disabilities Act
(ADA): Employment Issues and the 2009 Influenza Pandemic, by (name redacted).
220
P.L. 110-325, §4(a), amending 42 U.S.C. §12102(3). The ADA Amendments Act of 2008 expanded the definition
of disability from previous Supreme Court interpretations. For a more detailed discussion see CRS Report RL34691,
The ADA Amendments Act: P.L. 110-325, by (name redacted).
221
http://www.eeoc.gov/facts/pandemic_flu.html.
222
42 U.S.C. § 12112(d).
223
http://www.eeoc.gov/facts/pandemic_flu.html.
224
Id.
225
42 U.S.C. §12112(a)(5).
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also be provided on a laptop if laptops are provided to employees to enable them to work at home
during a pandemic.226 In addition, an employee who is at high risk for complications during a
pandemic may request telework as a reasonable accommodation. 227
Direct Threat
The ADA provides nondiscrimination protections to individuals with contagious diseases, but
balances this protection with requirements designed to protect the health of other individuals.
Title I of the ADA, which prohibits employment discrimination against otherwise qualified
individuals with disabilities, specifically states that “the term ‘qualifications standards’ may
include a requirement that an individual shall not pose a direct threat to the health or safety of
other individuals in the workplace.”228 During an influenza pandemic, the EEOC indicates that
employers would be permitted to advise employees to go home if they have influenza symptoms.
This would be true both if the illness is not considered to be a disability because it is similar to the
seasonal influenza, and if the illness were serious since it would then pose a direct threat.229
Like Title I, Title III, which prohibits discrimination in public accommodations and services
operated by private entities, states the following:
Nothing in this title shall require an entity to permit an individual to participate in or benefit
from the goods, services, facilities, privileges, advantages and accommodations of such
entity where such individual poses a direct threat to the health or safety of others. The term
‘direct threat’ means a significant risk to the health or safety of others that cannot be
eliminated by a modification of policies, practices, or procedures or by the provision of
auxiliary aids or services.230
Although Title II, which prohibits discrimination by state and local government services, does not
contain such specific language, it does require an individual to be “qualified” which is defined in
part as meeting “the essential eligibility requirements of the receipt of services or the participation
in programs or activities.”231 This language has been found by the Department of Justice to
require the same interpretation of direct threat as in Title III.232
Contagious diseases were discussed in the ADA’s legislative history. The Senate Report noted that
the qualification standards permitted with regard to employment under Title I may include a
requirement that an individual with a currently contagious disease or infection shall not pose a
direct threat to the health or safety of other individuals in the workplace and cited to School
Board of Nassau County v. Arline,233 the Section 504 case discussed previously.234 Similarly, the
226
See http://www.eeoc.gov/facts/pandemic_flu.html.
Id.
228
42 U.S.C. §12113(b). See also CRS Report RL33609, Quarantine and Isolation: Selected Legal Issues Relating to
Employment, by (name redacted) and (name redacted).
229
http://www.eeoc.gov/facts/pandemic_flu.html.
230
42 U.S.C. §12182(3).
231
42 U.S.C. §12131(2).
232
28 C.F.R. Part 35, Appx A.
233
480 U.S. 273, 287, note 16 (1987).
234
S.Rept. 101-116, 101st Cong., 1st Sess. reprinted in Vol. I, Committee Print Serial No. 102-A Legislative History of
P.L. 101-336, The Americans with Disabilities Act, prepared for the House Committee on Education and Labor at 139
(continued...)
227
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House report of the Committee on Education and Labor reiterated the reference to Arline and
added, “[t]hus the term ‘direct threat’ is meant to connote the full standard set forth in the Arline
decision.”235
The Air Carrier Access Act236
The Air Carrier Access Act (ACAA) prohibits discrimination by air carriers against “otherwise
qualified individual[s]” on the basis of disability. 237 Enacted in 1986,238 prior to the ADA, the
ACAA contains no statutory reference to communicable diseases, but the regulatory text
specifically addresses them. 239 Additionally, the regulatory definition of “individual with a
disability” appears to include individuals with communicable diseases.240 The regulations prohibit
various actions by carriers against individuals with communicable diseases. A carrier may not
“(1) [r]efuse to provide transportation to the passenger; (2) [d]elay the passenger’s transportation;
(3) [i]mpose on the passenger any condition, restriction, or requirement not imposed on other
passengers; or (4) [r]equire the passenger to provide a medical certificate.”241 However, an
exception applies when “the passenger’s condition poses a direct threat.”242 The regulations
define “direct threat” as “a significant risk to the health or safety of others that cannot be
eliminated by a modification of policies, practices, or procedures, or by the provision of auxiliary
aids or services.”243
(...continued)
(December 1990).
235
H.Rept. 101-485, 101st Cong., 2nd Sess., reprinted in Vol. I, Committee Print Serial No. 102-A Legislative History of
P.L. 101-336, The Americans with Disabilities Act, prepared for the House Committee on Education and Labor at 349
(December 1990). See also 136 Cong. Rec. 10858 (1990).
236
This subsection was written by (name redacted), Legislative Attorney. For a more detailed discussion of the ACAA
see CRS Report RL34047, Overview of the Air Carrier Access Act, by (name redacted).
237
49 U.S.C. §41705.
238
Air Carrier Access Act of 1986, 100 Stat. 1080 (1986) (current version at 49 U.S.C. §41705).
239
14 C.F.R. § 382.21 (2009).
240
14 C.F.R. § 382.3 (2009) (referring to “a physical or mental impairment that, on a permanent or temporary basis,
substantially limits one or more major life activities, has a record of such an impairment, or is regarded as having such
an impairment”). Similarly, courts generally accept communicable diseases as falling within the scope of “disability”
under the ADA if the diseases meet the same parameters that other physical or mental impairments must satisfy. See
Bragdon v. Abbott, 524 U.S. 624, 631-42 (1998). Although no federal court has reached the issue, it follows that courts
would likely reach similar conclusions under the ACAA.
241
14 C.F.R. § 382.21(a) (2009).
242
14 C.F.R. § 382.21(a) (2009).
243
14 C.F.R. § 382.3 (2009).
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Liability Issues
The Public Readiness and Emergency Preparedness Act (PREP
Act)244
The “Public Readiness and Emergency Preparedness Act” (PREP Act)245 created § 319F-3 of the
Public Health Service Act, which can limit claims based on public health “countermeasures,”
such as drugs or vaccines, when used under specified emergency conditions. Specifically, upon a
determination by the Secretary of HHS that either a public health emergency or the credible risk
of such emergency exists,246 the Secretary may declare that, with one exception, certain “covered
persons” shall be immune from suit under state and federal law with respect to claims arising
from the administration or use of a “covered countermeasure.”
“Covered persons” include the United States, manufacturers, distributors, program planners,247
persons who prescribe, administer or dispense the countermeasure, and employees of any of the
above. A “covered countermeasure” includes (A) “a qualified pandemic or epidemic product,” (B)
“a security countermeasure,” or (C) a drug, biological product, or device that is authorized for
emergency use in accordance with section 564 of the Federal, Food, Drug, and Cosmetic Act.248
Each of the terms in (A), (B), and (C) is itself defined in the PREP Act.
The one exception to absolute immunity applies to suits which allege that death or serious
physical injury resulted from the willful misconduct of a covered person. These cases may be
brought exclusively under a new federal cause of action, with special pleading requirements and
procedures specified under the PREP Act. Some potential defendants, such as state or local
officials and health care providers who administer or dispense the countermeasure, may also
avoid liability for a death or physical injury if they act consistently with guidance issued by the
Secretary of HHS and also notify public health authorities of any resulting death or injury within
seven days after the death or injury is discovered.249
As an alternative to litigation, victims may accept payment under the “Covered Countermeasure
Process Fund,” if Congress has appropriated money for that purpose.250 Amounts and types of
244
This section was written by Vanessa Burrows, Legislative Attorney. For a more detailed discussion of the PREP Act
see CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by (name
redacted) and (name redacted).
245
Division C of P.L. 109-148 (2005), 42 U.S.C. §§ 247d-6d, 247d-6e.
246
This declaration authority is independent of the Secretary’s authority under Section 319 of the Public Health Service
Act, 42 U.S.C. 247d, and other similar authorities.
247
Program planners include “a State or local government, including an Indian tribe, a person employed by the State or
local government, or other person who supervised or administered a program with respect to the administration,
dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product,
including a person who has established requirements, provided policy guidance, or supplied technical or scientific
advice or assistance or provides a facility to administer or use a covered countermeasure.” 42 U.S.C. § 247d-6d(i)(6).
248
See supra at “Emergency Use Authorizations (for Unapproved Countermeasures).”
249
42 U.S.C. § 247d-6d(c)(4).
250
Such an appropriation is currently pending. See CRS Report R40554, The 2009 Influenza Pandemic: An Overview,
by (name redacted) and (name redacted), under “Appropriations and Funding.” Compensation is also available to
eligible individuals whose countermeasure-caused injuries were not the result of willful misconduct.
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compensation under this fund would be the same as are provided for persons injured by certain
smallpox countermeasures under the Smallpox Emergency Personnel Protection Act of 2003.251
These include medical benefits, compensation for lost employment income, and death benefits;
damages for pain and suffering or other non-economic injuries are not available.
On June 25, 2009, HHS Secretary Kathleen Sebelius issued a declaration under the PREP Act for
the use of H1N1 pandemic vaccines that are currently under development, thereby providing
immunity and enabling the compensation program, contingent upon appropriations.252 Earlier, on
June 19, the Secretary amended an earlier declaration, providing immunity and enabling
compensation (contingent upon appropriations) for the use of the antiviral drugs Tamiflu and
Relenza for treatment of illnesses caused by H1N1 pandemic flu. 253
Civil Liability of Volunteers and Volunteer Health Professionals254
When disasters occur, it is common for volunteer health professionals (VHPs) to go to affected
areas and offer their medical services. Typically, such individuals are licensed medical
professionals who gratuitously provide their services in response to these regions’ clear need for
medical skills and services. In these scenarios, questions have arisen regarding the potential civil
liability of VHPs, particularly with regard to medical malpractice liability. The civil liability of
VHPs may be a concern that arises within the context of the 2009 influenza pandemic depending
upon the development of the pathogen and how future events unfold.
A patchwork of federal and state laws generally operates to protect volunteers, which may include
VHPs, and there are also laws that trigger liability protection specifically for VHPs. Whether a
VHP is protected from civil liability depends on a number of factors, including under whose
control the VHP operates and whether or not a state of emergency has been declared. It is
important to note that liability protections shield volunteers from all civil liability for negligent
conduct, i.e., a failure to take adequate care that results in injuries or losses to others. Civil
liability for conduct that is more egregious than mere negligence, such as willful, or grossly
negligent conduct, is generally not protected.
Volunteer Protection Acts
Laws shielding volunteers from liability have been enacted on both the federal and state level;
these statutes apply in non-emergency situations as well as emergency situations. On the federal
level, Congress passed the Volunteer Protection Act (VPA) in 1997.255 This statute provides
immunity to volunteers (not only medical volunteers) of non-profit organizations or governmental
entities for ordinary negligence so long as certain conditions are met.256 The VPA does not
251
P.L. 108-20, § 2 (2003), codified at 42 U.S.C. §§ 239c, 239d, and 239e.
252
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, “Pandemic Influenza Vaccines–
Amendment,” 74 Fed. Reg. 30294-30297 (June 25, 2009).
253
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, “Pandemic Influenza Antivirals–
Amendment,” 74 Fed. Reg. 29213-29214 (June 19, 2009).
254
This section was written by (name redacted), Legislative Attorney. For a more detailed analysis of these issues see
CRS Report R40176, Emergency Response: Civil Liability of Volunteer Health Professionals, by (name redacted).
255
P.L. 105-19, codified, as amended, 42 U.S.C. § 14501 et seq. For background, see CRS Report 97-490, Volunteer
Protection Act of 1997, by (name redacted).
256
42 U.S.C. § 14503(a).
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prohibit the non-profit or governmental entity from bringing a civil action against its own
volunteers; nor does the VPA shield from liability the non-profit or governmental entity for the
actions of its volunteers. Furthermore, it expressly preempts state standards that provide less
protection.257 All 50 states and the District of Columbia have enacted their own volunteer
protection statutes that provide liability protection greater than the federal VPA but to varying
degrees. Additionally, many states have enacted statutory provisions geared specifically toward
providing VHPs with immunity from civil liability and that, like the VPA, are not dependent on,
or triggered by, an emergency situation. 258
Liability Protection During a State of Emergency
Except insofar as they waive it, the federal and state governments enjoy sovereign immunity from
suit. The federal government has waived its immunity with the passage of the Federal Tort Claims
Act, 259 and some state governments have similar statutory provisions. Such acts generally
immunize government employees from tort liability for torts committed within their scope of
employment, and instead allow the government to be held liable in accordance with the law of the
state where a tort occurred.
An additional way to shield VHPs from individual civil liability during an emergency is to
declare them non-paid employees of the federal government or a state government for liability
purposes.260 This can be done for particular volunteers in all situations or only when a general
state of emergency or public health emergency has been declared.261 Emergencies can be declared
at both federal and state levels. 262 Every state has a regime for declaring a general emergency or
disaster, and such a declaration can explicitly trigger liability protections or allow the governor to
do so.263 In addition to general emergency procedures, some states have regimes for public health
emergencies, which, like general emergency management statutes, provide varying degrees of
coverage. The declaration of a public health emergency triggers special protections for medical
257
Id. at § 14503(d). However, the VPA permits states to enact statutes that declare the non-applicability of the act “to
any civil action in a State court against a volunteer in which all parties are citizens of the State.” See id. at § 14502.
Thus far, only New Hampshire has done so.
258
In addition to VPAs, every state and the District of Columbia has enacted its own “Good Samaritan” statute, which
protects individuals who gratuitously provide emergency assistance from civil liability.
259
28 U.S.C. §§ 1346(b), 2671-80. See CRS Report 95-717, Federal Tort Claims Act (FTCA), by (name redacted) and
(name redacted)
260
The Pandemic and All-Hazards Preparedness Act, P.L. 109-417, provides an example of such tort liability
protections. Under 42 U.S.C. § 300hh-11(d)(1), the Secretary of the HHS may appoint volunteer health professionals as
intermittent personnel of the National Disaster Medical System (NDMS), which provides medical services when a
disaster overwhelms local emergency services. NDMS volunteers benefit from the same immunity from civil liability
as the employees of the Public Health Service. The Secretary may also accept the assistance of the VHPs as temporary
volunteers under 42 U.S.C. § 217b. Under applicable regulations, such volunteers may receive legal protections
including protection from civil liability claims under the FTCA. See e.g., 45 C.F.R. § 57.5; see http://www.hhs.gov/
aspr/opeo/ndms/join/index.html.
261
See also CRS Report RS20984, Public Health Service Act Provisions Providing Immunity from Medical
Malpractice Liability, by (name redacted); CRS Report 97-579,
Making Private Entities and Individuals Immune from
Tort Liability by Declaring Them Federal Employees, by (name redacted).
262
See Sharona Hoffman, Responders’ Responsibility: Liability and Immunity in Public Health Emergencies, 96 Geo.
L.J. 1913, 1921 (2008).
263
For a discussion of state public health emergency response authorities, see James G. Hodge and Evan D. Anderson,
Principles and Practice of Legal Triage During Public Health Emergencies, 64 N.Y.U. Ann. Surv. Am. L. 649 (2008),
available at, http://www1.law.nyu.edu/pubs/annualsurvey/issues/documents/64_NYU_ASAL_249_2008.pdf.
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The 2009 Influenza Pandemic: Selected Legal Issues
personnel, which often include liability protection for VHPs. Even where emergency or public
health emergency statutes do not explicitly grant liability protections to VHPs, these statutes
generally allow governors to impose such protections for volunteers where appropriate.
Emergency Mutual Aid Agreements
Emergency mutual aid agreements may be instituted among political subdivisions and Indian
tribal nations within a state, out-of-state with neighboring political subdivisions, or internationally
with Canadian provinces. Approved by Congress in 1996, the Emergency Management
Assistance Compact (EMAC)264 provides a prearranged structure for a state to request aid from
other states when affected by disaster. Since 1996, all 50 states have agreed to the terms of
EMAC, as have the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and Guam. Under
EMAC, a person from one state who renders assistance in another and who holds a license,
certificate, or other permit for the practice of professional, mechanical, or other skills is
considered to be licensed, certified, or permitted to exercise those duties in the requesting state,
subject to limitations or conditions set by the governor of the requesting state. Notwithstanding
the recognition of out-of-state licenses, reciprocity is not automatically extended to VHPs who do
not provide services pursuant to an EMAC request for assistance. Following September 11, 2001,
Congress created the Emergency System for Advance Registration of Volunteer Health
Professionals so that emergency managers and others can have the ability to quickly identify and
facilitate the use of VHPs in local, state, and federal emergency response.265
Employment Issues
Introduction266
Questions relating to employment are among the most significant issues presented by an
influenza pandemic, since, if individuals fear losing their employment or their wages, compliance
with public health measures such as isolation or quarantine may suffer. Controlling or preventing
an influenza pandemic involves the same strategies used for seasonal influenza. These strategies
are vaccination, treatment with antiviral medications, and the use of infection control measures.267
CDC states that vaccination planners should assume that shipping of H1N1 vaccine will begin
mid-October, although some vaccine may be available for shipping earlier.268 Therefore, the use
of other infection control measures may be critical. These measures can include having workers
264
P.L. 104-321. EMAC is intended to encourage mutual assistance in “any emergency or disaster that is duly declared
by the governor of the affected state(s),” including “natural disaster, technological hazard, man-made disaster, civil
emergency aspects of resources shortages, community disorders, or enemy attack.” EMAC, Art. I. See also CRS Report
RL34585, The Emergency Management Assistance Compact (EMAC): An Overview, by (name redacted).
265
Public Health Security and Bioterrorism Preparedness and Response Act § 107, 42 U.S.C. §247d-7b.
266
This section was written by (name redacted), Legislative Attorney. The ADA and other civil rights acts may also
cover employment decisions during a pandemic. For a discussion of these issues see the previous section on civil rights,
CRS Report R40866, The Americans with Disabilities Act (ADA): Employment Issues and the 2009 Influenza
Pandemic, by (name redacted), and http://www.eeoc.gov/facts/pandemic_flu.html.
267
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan 107 (GPO May 2006).
268
“CDC Novel H1N1 Vaccination Planning Q&A,” http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm.
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stay home when they are sick. However, this is difficult for the large number of private sector
workers who do not have paid sick leave.269
The uses of quarantine and isolation, as well as social distancing and “snow days,” are discussed
in the Homeland Security Council’s Pandemic Influenza Implementation Plan270 as ways to
attempt to limit the spread of influenza.271 Quarantine is defined as the “separation of individuals
who have been exposed to an infection but are not yet ill from others who have not been exposed
to the transmissible infection.”272 Isolation is defined as the “separation of infected individuals
from those who are not infected.”273 Social distancing is defined as “infection control strategies
that reduce the duration and/or intimacy of social contacts and thereby limit the transmission of
influenza.”274 Social distancing can include the use of face masks, teleconferencing, or school
closures. “Snow days,” a type of social distancing, are the recommendation or mandate by
authorities that individuals and families limit social contacts by remaining within their
households. 275
The Centers for Disease Control and Prevention (CDC) issued interim planning guidance for
communities to mitigate the impact of pandemic influenza.276 This guidance introduced a
Pandemic Severity Index, which ranks the severity of a pandemic like the categories given to
hurricanes and links the severity to specific community interventions. The community
interventions include isolation and voluntary quarantine, school dismissals, and the use of social
distancing measures to reduce contact. The social distancing measures include the cancellation of
large public gatherings and the alteration of workplace environments and schedules to decrease
social density.277 The guidance noted the importance of workplace leave policies that would
“align incentives and facilitate adherence with the nonpharmaceutical interventions. ”278
Strategies to minimize the impact of workplace absenteeism were discussed in some detail and
included the use of staggered shifts and telework. Unemployment insurance was mentioned as
potentially available, as was disaster unemployment assistance. The guidance also observed that
the Family and Medical Leave Act may offer some job security protections. 279
269
See The Trust for America’s Health, H1N1 Challenges Ahead, http://healthyamericans.org/reports/h1n1/
TFAH2009challengesahead.pdf.
270
Id. at 72-73, 107-109.
271
Although the precise effectiveness of these measures is not known, a study by the Institute of Medicine indicated
that there is a role for community-wide interventions such as isolation or voluntary quarantine. Institute of Medicine,
“Modeling Community Containment for Pandemic Influenza: A Letter Report,” Dec. 11, 2006.
272
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan 209 (GPO May 2006).
273
Id. at 207.
274
Id. at 209.
275
Id.
276
Centers for Disease Control and Prevention (CDC), Interim Pre-pandemic Planning Guidance: Community Strategy
of Pandemic Influenza Mitigation in the United States—Early, Targeted, Layered Use of Nonpharmaceutical
Interventions (February 2007), http://www.pandemicflu.gov/plan/community/mitigation.html. The American Public
Health Association has also issued recommendations with rega
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