42 U.S.C. § 239 — General provisions

Page 126 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 239 1 So in original. Probably should be ‘‘specialties’’. (2) Civil actions under Federal law (A) In general The applicability of subsections (a) and (b) includes applicability to any action for civil liability described in subsection (a) that arises under Federal law. (B) Federal areas adopting State law If a geographic area is under Federal juris- diction and is located within a State but out of the jurisdiction of the State, and if, pur- suant to Federal law, the law of the State applies in such area regarding matters for which there is no applicable Federal law, then an action for civil liability described in subsection (a) that in such area arises under the law of the State is subject to subsections (a) through (c) in lieu of any related State law that would apply in such area in the ab- sence of this subparagraph. (d) Federal jurisdiction In any civil action arising under State law, the courts of the State involved have jurisdic- tion to apply the provisions of this section ex- clusive of the jurisdiction of the courts of the United States. (e) Definitions (1) Perceived medical emergency For purposes of this section, the term ‘‘per- ceived medical emergency’’ means cir- cumstances in which the behavior of an indi- vidual leads a reasonable person to believe that the individual is experiencing a life- threatening medical condition that requires an immediate medical response regarding the heart or other cardiopulmonary functioning of the individual. (2) Other definitions For purposes of this section: (A) The term ‘‘automated external defibrillator device’’ means a defibrillator device that— (i) is commercially distributed in accord- ance with the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; (ii) is capable of recognizing the presence or absence of ventricular fibrillation, and is capable of determining without inter- vention by the user of the device whether defibrillation should be performed; (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an individual; and (iv) in the case of a defibrillator device that may be operated in either an auto- mated or a manual mode, is set to operate in the automated mode. (B)(i) The term ‘‘harm’’ includes physical, nonphysical, economic, and noneconomic losses. (ii) The term ‘‘economic loss’’ means any pecuniary loss resulting from harm (includ- ing the loss of earnings or other benefits re- lated to employment, medical expense loss, replacement services loss, loss due to death, burial costs, and loss of business or employ- ment opportunities) to the extent recovery for such loss is allowed under applicable State law. (iii) The term ‘‘noneconomic losses’’ means losses for physical and emotional pain, suffering, inconvenience, physical im- pairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium (other than loss of domestic service), hedonic dam- ages, injury to reputation and all other non- pecuniary losses of any kind or nature. (July 1, 1944, ch. 373, title II, § 248, as added Pub. L. 106–505, title IV, § 404, Nov. 13, 2000, 114 Stat. 2338.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. PART C—SMALLPOX EMERGENCY PERSONNEL PROTECTION § 239. General provisions (a) Definitions For purposes of this part: (1) Covered countermeasure The term ‘‘covered countermeasure’’ means a covered countermeasure as specified in a Declaration made pursuant to section 233(p) of this title. (2) Covered individual The term ‘‘covered individual’’ means an in- dividual— (A) who is a health care worker, law en- forcement officer, firefighter, security per- sonnel, emergency medical personnel, other public safety personnel, or support personnel for such occupational specialities 1; (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human Services smallpox emer- gency response plan (as defined in paragraph (7)) approved by the Secretary; (C) who has volunteered and been selected to be a member of a smallpox emergency re- sponse plan described in subparagraph (B) prior to the time at which the Secretary publicly announces that an active case of smallpox has been identified either within or outside of the United States; and (D) to whom a smallpox vaccine is admin- istered pursuant to such approved plan dur- ing the effective period of the Declaration (including the portion of such period before April 30, 2003). (3) Covered injury The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures established under section 239a of this title, to have been sustained by an indi- vidual as the direct result of— Page 127 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 239a (A) administration to the individual of a covered countermeasure during the effective period of the Declaration; or (B) accidental vaccinia inoculation of the individual in circumstances in which— (i) the vaccinia is contracted during the effective period of the Declaration or with- in 30 days after the end of such period; (ii) smallpox vaccine has not been ad- ministered to the individual; and (iii) the individual has been in contact with an individual who is (or who was acci- dentally inoculated by) a covered indi- vidual. (4) Declaration The term ‘‘Declaration’’ means the Declara- tion Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003. (5) Effective period of the Declaration The term ‘‘effective period of the Declara- tion’’ means the effective period specified in the Declaration, unless extended by the Sec- retary. (6) Eligible individual The term ‘‘eligible individual’’ means an in- dividual who is (as determined in accordance with section 239a of this title)— (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or (B) an individual who sustains a covered injury in the manner described in paragraph (3)(B). (7) Smallpox emergency response plan The term ‘‘smallpox emergency response plan’’ or ‘‘plan’’ means a response plan detail- ing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an ac- tive case of smallpox either within or outside the United States. (b) Voluntary program The Secretary shall ensure that a State, local, or Department of Health and Human Services plan to vaccinate individuals that is approved by the Secretary establishes procedures to en- sure, consistent with the Declaration and any applicable guidelines of the Centers for Disease Control and Prevention, that— (1) potential participants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part; (2) there is voluntary screening provided to potential participants that can identify health conditions relevant to contraindications; and (3) there is appropriate post-inoculation medical surveillance that includes an evalua- tion of adverse health effects that may reason- ably appear to be due to such vaccine and prompt referral of, or the provision of appro- priate information to, any individual requir- ing health care as a result of such adverse health event. (July 1, 1944, ch. 373, title II, § 261, as added Pub. L. 108–20, § 2, Apr. 30, 2003, 117 Stat. 638.) § 239a. Determination of eligibility and benefits (a) In general The Secretary shall establish procedures for determining, as applicable with respect to an in- dividual— (1) whether the individual is an eligible indi- vidual; (2) whether an eligible individual has sus- tained a covered injury or injuries for which medical benefits or compensation may be available under sections 239c and 239d of this title, and the amount of such benefits or com- pensation; and (3) whether the covered injury or injuries of an eligible individual caused the individual’s death for purposes of benefits under section 239e of this title. (b) Covered individuals The Secretary may accept a certification, by a Federal, State, or local government entity or private health care entity participating in the administration of covered countermeasures under the Declaration, that an individual is a covered individual. (c) Criteria for reimbursement (1) Injuries specified in injury table In any case where an injury or other adverse effect specified in the injury table established under section 239b of this title as a known ef- fect of a vaccine manifests in an individual within the time period specified in such table, such injury or other effect shall be presumed to have resulted from administration of such vaccine. (2) Other determinations In making determinations other than those described in paragraph (1) as to the causation or severity of an injury, the Secretary shall employ a preponderance of the evidence stand- ard and take into consideration all relevant medical and scientific evidence presented for consideration, and may obtain and consider the views of qualified medical experts. (d) Deadline for filing request The Secretary shall not consider any request for a benefit under this part with respect to an individual, unless— (1) in the case of a request based on the ad- ministration of the vaccine to the individual, the individual files with the Secretary an ini- tial request for benefits or compensation under this part not later than one year after the date of administration of the vaccine; or (2) in the case of a request based on acci- dental vaccinia inoculation, the individual files with the Secretary an initial request for benefits or compensation under this part not later than two years after the date of the first symptom or manifestation of onset of the ad- verse effect. (e) Structured settlements at Secretary’s option In any case in which there is a reasonable likelihood that compensation or payment under section 239c, 239d, or 239e(b) of this title will be required for a period in excess of one year from the date an individual is determined eligible for