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GENERAL
Q.1. What
is the purpose of Section 304 of the Homeland Security Act?
A.1.
Manufacturers of smallpox vaccine and those healthcare entities that would
administer the vaccine 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 alleviate these liability concerns
and therefore ensure that vaccine is available and can be administered,
particularly in the event of a smallpox-related actual or potential public
health emergency such as a bioterrorist incident.
Q.2. In
general, what does Section 304 provide?
A.2.
Section 304 provides an exclusive remedy against the United States for
injury or death attributable to smallpox vaccine, other substances used to
treat or prevent smallpox, or vaccinia immune globulin ("smallpox
countermeasures"). This means that no claim for liability for injury or
death attributable to a smallpox countermeasure could be brought against
entities or individuals who are covered by Section 304's protections.
Q.3. When
do the provisions of Section 304 become effective?
A.3.
The effective date, as established in Section 4 of the Homeland Security
Act, is January 24, 2003. If vaccination is to begin sooner, Section 304
would apply at that earlier time only if Congress enacts legislation moving
up the effective date.
FILING A
CLAIM
Q.4. If I
am injured as a result of receiving a smallpox countermeasure, how do I know
if I can file a Section 304 claim?
A.4.
Section 304 is triggered if and when a smallpox countermeasure is
administered pursuant to a declaration by the Secretary of Health and Human
Services. The declaration will specify the administration of particular
countermeasures to one or more categories of individuals, and it will state
how long it is in effect. An individual described in the declaration who
receives one of those countermeasures from a qualified person while the
declaration is in effect, and who is injured as a result, may file a claim
under Section 304.
Q.5. Who
is a "qualified person?"
A.5.
Qualified persons 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 the countermeasure is administered by a qualified
person.
Q.6. If I
contract vaccinia without having received smallpox vaccine, can I file a
Section 304 claim?
A.6.
Individuals who were not inoculated, 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 was inoculated pursuant to the
declaration, may submit claims.
Q.7. What
is the process for filing a Section 304 claim?
A.7.
Anyone who believes he or she has a claim for money damages attributable to
injury or death due to smallpox countermeasures must submit an
administrative claim with an appropriate agency of the United States within
two years. If the agency denies the claim, or if no action is taken on the
claim within six months, the injured individual may file suit in federal
court.
Q.8. May
the Secretary make the declaration prior to the occurrence of a bioterrorist
incident or public health emergency?
A.8.
A declaration can be made if the Secretary concludes that an actual or
potential bioterrorist incident or other actual or potential public
health emergency makes the administration advisable. The Secretary can,
therefore, make the declaration prior to the occurrence of a bioterrorist
incident or public health emergency.
COVERED
ENTITIES
Q.9. What
entities are covered by Section 304's protections?
A.9.
With respect to administration of a covered countermeasure, manufacturers
and distributors of countermeasures, healthcare entities under whose
auspices the countermeasure is administered, and licensed health care
professionals or other individuals authorized to administer the
countermeasure under state law are covered by Section 304. In addition, any
official, agent, or employee of any of these entities is also covered.
Q.10. Are
state and local health departments and their employees covered by Section
304?
A.10.
State and local health departments that act as distributors of
countermeasures or that are healthcare entities under whose auspices
countermeasures are administered are covered by Section 304. Their
officials, agents, or employees are also covered for actions arising out of
the administration of a countermeasure.
Q.11.
Does Section 304 contain any limitations for covering these entities?
A.11.
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 item A.9 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 A.9, 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.
OTHER
Q.12.
What effect does Section 304 have upon federal or state workers'
compensation schemes?
A.12.
Workers covered by state workers' compensation statutes who suffer
work-related injuries from the countermeasure may be barred from submitting
a Section 304 claim if those state laws constitute an exclusive remedy.
Federal employees who suffer such work-related injuries may only file claims
pursuant to the Federal Employees' Compensation Act.
Q.13.
What legal standards apply to Section 304 claims?
A.13.
In general, suits would be governed by state law as to liability and
damages, except when provisions of the federal law provided otherwise. For
example, a claimant must demonstrate that the injury or death attributable
to the countermeasure was the result of a negligent or wrongful act or
omission, regardless of the standard in the state where the act or omission
occurred.
Q.14.
Does the statute authorize payment for lost time from work or health care
costs necessary for treating the injury?
A.14.
If a claimant prevails on a Section 304 claim, damages would be determined
according to state law, within any limits imposed by federal law. While loss
of income and health care costs generally are recoverable, Section 304 does
not establish a "no-fault" compensation program. See items A.2
and A.13. Individuals may wish to review their health
insurance policies to determine whether they cover health-care costs for
injuries attributable to administration of a smallpox countermeasure. For
information on Section 304's interaction with workers' compensation claims,
see item A.12.
Q.15. Are
all persons working in a vaccination clinic covered by Section 304?
A.15.
A vaccination clinic, as a healthcare entity under whose auspices a
countermeasure is administered, is covered by Section 304 protections. Any
official, employee, or agent of such a vaccination clinic would therefore
also be covered by Section 304 protections for actions arising out of the
administration of a countermeasure. See item A.9.
Q.16.
Will hospitals or other institutions who employ vaccinees but who do not
operate as a clinic administering countermeasures be covered by Section 304
protections?
A.16.
Generally, no. Only hospitals and institutions under whose auspices
countermeasures are administered are covered by Section 304 protections. |
