119 STAT. 2824
‘‘(iii) FINAL.—The terms ‘final’ and ‘finally’— ‘‘(I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and ‘‘(II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal. ‘‘(C) RULES OF CONSTRUCTION.— ‘‘(i) IN GENERAL.—Nothing in this paragraph shall be construed— ‘‘(I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act, of this Act, or of any other applicable statute or regulation; or ‘‘(II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this Act, under the Federal Food, Drug, and Cosmetic Act, under title 18 of the United States Code, or under any other applicable statute or regulation. ‘‘(ii) MANDATORY RECALLS.—A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action. ‘‘(d) EXCEPTION TO IMMUNITY OF COVERED PERSONS.— ‘‘(1) IN GENERAL.—Subject to subsection (f), the sole exception to the immunity from suit and liability of covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct, as defined pursuant to subsection (c), by such covered person. For purposes of section 2679(b)(2)(B) of title 28, United States Code, such a cause of action is not an action brought for violation of a statute of the United States under which an action against an individual is otherwise authorized. ‘‘(2) PERSONS WHO CAN SUE.—An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any representative of such a person. ‘‘(e) PROCEDURES FOR SUIT.— ‘‘(1) EXCLUSIVE FEDERAL JURISDICTION.—Any action under subsection (d) shall be filed and maintained only in the United States District Court for the District of Columbia. ‘‘(2) GOVERNING LAW.—The substantive law for decision in an action under subsection (d) shall be derived from the law, including choice of law principles, of the State in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions of this section.
Records. Courts, U.S. District of Columbia.
VerDate 14-DEC-2004
07:21 Oct 30, 2006
PUBLIC LAW 109–148—DEC. 30, 2005
Jkt 039194
PO 00003
Frm 00292
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL003.119
APPS06
PsN: PUBL003
�
