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Vaccine injury due to negligence or wrongful act
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.
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. (See the HHS Declaration Regarding Administration of Smallpox Countermeasures [215 KB/5 pages].)
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:
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 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:
manufacturers and distributors of countermeasures, hospitals, clinics, and other healthcare entities under whose auspices the countermeasures are administered, and 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.
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