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Guidance
for the Healthcare Community Concerning Section 304 of the
Homeland Security Act
Manufacturers of smallpox
vaccine and those healthcare entities under whose auspices
the vaccine would be administered have raised concerns about
their potential liability for involvement in a federal smallpox
vaccination campaign. Section 304 of the Homeland Security
Act is intended to relieve these liability concerns and
therefore ensure that vaccine is available and can be administered
in the event of an actual or potential public health emergency.
The following represents the Department of Health and Human
Services' interpretation of Section 304, but is not an exhaustive
review of Section 304's provisions in all contexts.
Overview
Under Section 304, no claim for liability for injury or
death arising out of the administration of smallpox vaccine,
other substances used to treat or prevent smallpox, or vaccinia
immune globulin ("countermeasures") can be brought
against entities or individuals who are covered by Section
304's protections. Instead these claims must be made against
the United States. 1
Section 304 is triggered when the Secretary of Health and
Human Services declares that administration of a countermeasure
is advisable. The Secretary can make the declaration upon
concluding that an actual or potential bioterrorist incident
or other actual or potential public health emergency makes
the administration advisable, meaning that it can be made
prior to the occurrence of a bioterrorist incident or public
health emergency.
Among other things, the declaration will specify the category
or categories of individuals it covers, and it will state
how long it is in effect. It also will specify the countermeasures
it covers, including vaccinia (smallpox) vaccine, cidofovir,
and vaccinia immune globulin. To fully implement Section
304, the declaration also will provide further clarification
of the statute's coverage.
Section 304 does not establish a compensation program that
pays for any injury caused by administration of a smallpox
countermeasure. In order to recover any payment pursuant
to Section 304, an injured person must show that his/her
injury is due to the negligence or wrongful act of an entity
covered by Section 304's protections.
Who Can File a Claim
Section 304 claims may be filed by:
(1) injured individuals described in the declaration
who, while the declaration is in effect, receive a declared
countermeasure from a licensed health professional or
other individual authorized to administer countermeasures
under state law, or
(2) injured individuals who did not receive a countermeasure,
but who nonetheless contract vaccinia during the period
of the Secretary's declaration or 30 days thereafter,
or who reside or resided with an individual who did receive
a countermeasure pursuant to the declaration.
Anyone in these categories who believes he or she has a
claim attributable to injury or death due to a smallpox
countermeasure must submit an administrative claim with
an appropriate agency of the United States within two years
of the accrual of that claim. If an administrative claim
is denied, or if no action is taken on the claim within
six months, the injured individual may file suit in federal
court.
Who is Protected
The entities and individuals covered by Section 304's protections
are:
(1) manufacturers and distributors of countermeasures,
(2) hospitals, clinics, and other healthcare entities
under whose auspices the countermeasures are administered,
and
(3) licensed health care professionals or other individuals
authorized to administer the countermeasures under state
law ("qualified persons").
Officials, agents, and employees of any of these entities
are also covered for claims arising out of the administration
of a countermeasure that occur within the scope of employment.
Scope of Protection for State and Local
Health Departments
State and local health departments that act as distributors
of countermeasures or that are healthcare entities under
whose auspices countermeasures are administered, as well
as their officials, agents, and employees, are covered by
Section 304.
Scope of Protection for Hospitals and
Vaccine Clinics
Hospitals and other institutions that operate as vaccination
clinics are covered by Section 304's protections for claims
arising out of the administration of a countermeasure.
In addition, the Secretary's declaration may determine
that hospitals that designate employees to receive smallpox
countermeasures under a state's smallpox plan are considered
to be participants in the program and thus are healthcare
entities under whose auspices the countermeasure is administered.
In these circumstances, we believe that hospitals or other
institutions that employ these vaccinees but that do not
operate as a clinic administering countermeasures would
be covered by Section 304 protections for claims arising
out of the administration of a countermeasure.
Scope of Protection for Healthcare Workers
"Qualified persons," as noted above, are licensed
health professionals or other individuals authorized to
administer smallpox countermeasures under state law. Section
304 claims may be filed for injuries due to administration
of countermeasures only if a qualified person administers
the countermeasure.
Qualified persons are generally covered by Section 304's
protections for claims arising out of the administration
of a countermeasure that occur within the scope of the qualified
person's employment. In addition, Section 304's protections
cover individuals who are officials, agents, and employees
of entities listed in the Who is Protected
section, above.
Limitations
If a claim under Section 304 is based on an action or omission
by a particular manufacturer, health care professional,
or other person listed under Who Is Protected, above,
and that person fails to cooperate with the
Government in the defense of the claim, the United States
will not be liable for any damages resulting from
that person's act or omission.
Also, if the United States makes a payment on a claim,
and the payment is based (partly or wholly) on gross negligence,
recklessness, illegal conduct, or willful misconduct by
the manufacturer, health care professional, or other person
listed under item Who Is Protected, or based on the
person's violation of a contract with the United States,
the United States may recover that portion of the payment
(with interest and litigation costs) from that person.
Workers' Compensation
Workers' compensation laws differ from state to state.
If a work-related injury is covered by a particular state's
workers' compensation law, that state's law will determine
whether the worker can sue any other person aside from the
employer.
Workers may be barred from submitting a Section 304 claim
if those state laws constitute an exclusive remedy
(See attached diagram).
If, on the other hand, the state law does allow a lawsuit
against a party other than the worker's employer, and the
lawsuit is against an entity or individual listed in the
Who is Protected section, the worker would have to bring
the lawsuit pursuant to Section 304 and prove that a negligent
or wrongful act occurred.
Federal employees who suffer work-related injuries may
only file claims pursuant to the Federal Employees' Compensation
Act.
Section 304 does not bar workers' compensation claims in
the way it bars other suits. Other statutes, e.g., the Federal
Tort Claims Act, that create similar remedies and that exclude
other claims have been interpreted as not excluding
workers' compensation claims.
Finally, workers' compensation claims themselves are not
transformed by this legislation into separate claims covered
by Section 304.
Footnotes:
1 - Section 304 claims would be brought against the
United States pursuant to the Federal Tort Claims Act, 28
U.S.C. §§ 1346(b), 2671, et seq.
Attachment
(1): Overview Section 304 Liability Protection for Injury
Claims Arising Out of Administration of Smallpox Countermeasures
Note: this diagram is for illustrative purpose only
and does not give rise to any rights, privileges, or immunities.
Click to view PDF [16KB].
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