119 STAT. 2822
provides an explanation of the reasons for issuing the declaration and the reasons underlying the determinations of the Secretary with respect to paragraph (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such committees a report that provides the reasons underlying the determination of the Secretary to make the amendment. ‘‘(c) DEFINITION OF WILLFUL MISCONDUCT.— ‘‘(1) DEFINITION.— ‘‘(A) IN GENERAL.—Except as the meaning of such term is further restricted pursuant to paragraph (2), the term ‘willful misconduct’ shall, for purposes of subsection (d), denote an act or omission that is taken— ‘‘(i) intentionally to achieve a wrongful purpose; ‘‘(ii) knowingly without legal or factual justification; and ‘‘(iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. ‘‘(B) RULE OF CONSTRUCTION.—The criterion stated in subparagraph (A) shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness. ‘‘(2) AUTHORITY TO PROMULGATE REGULATORY DEFINITION.— ‘‘(A) IN GENERAL.—The Secretary, in consultation with the Attorney General, shall promulgate regulations, which may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a covered person that may qualify as ‘willful misconduct’ for purposes of subsection (d). ‘‘(B) FACTORS TO BE CONSIDERED.—In promulgating the regulations under this paragraph, the Secretary, in consultation with the Attorney General, shall consider the need to define the scope of permissible civil actions under subsection (d) in a way that will not adversely affect the public health. ‘‘(C) TEMPORAL SCOPE OF REGULATIONS.—The regulations under this paragraph may specify the temporal effect that they shall be given for purposes of subsection (d). ‘‘(D) INITIAL RULEMAKING.—Within 180 days after the enactment of the Public Readiness and Emergency Preparedness Act, the Secretary, in consultation with the Attorney General, shall commence and complete an initial rulemaking process under this paragraph. ‘‘(3) PROOF OF WILLFUL MISCONDUCT.—In an action under subsection (d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each covered person sued and that such willful misconduct caused death or serious physical injury. ‘‘(4) DEFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO SECRETARY’S DECLARATION.—Notwithstanding any other provision of law, a program planner or qualified person shall not have engaged in ‘willful misconduct’ as a matter of law where such program planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure that is specified in the declaration
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PUBLIC LAW 109–148—DEC. 30, 2005
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