Source: https://www.law.cornell.edu/uscode/text/42/247d%E2%80%936d
Timestamp: 2018-11-15 23:02:34
Document Index: 474270980

Matched Legal Cases: ['§ 247', '§ 247', '§ 247', '§\u202f247', '§\u202f319', '§\u202f2', '§\u202f402', '§\u202f301', '§\u202f351', '§\u202f402', '§\u202f402', '§\u202f402']

42 U.S. Code § 247d–6d - Targeted liability protections for pandemic and epidemic products and security countermeasures | US Law | LII / Legal Information Institute
U.S. Code › Title 42 › Chapter 6A › Subchapter II › Part B › § 247d–6d
42 U.S. Code § 247d–6d - Targeted liability protections for pandemic and epidemic products and security countermeasures
§ 247d–6d.
(A) LossFor purposes of this section, the term “loss” means any type of loss, including—
(3) Certain conditionsSubject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—
the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;
(4) Applicability of certain conditionsWith respect to immunity under paragraph (1) and subject to the other provisions of this section:
(2) ContentsIn issuing a declaration under paragraph (1), the Secretary shall identify, for each covered countermeasure specified in the declaration—
the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in paragraph (6);
the population or populations of individuals for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
the geographic area or areas for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under subparagraph (C), a specification, as determined appropriate by the Secretary, of whether the declaration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and
whether subsection (a) is effective only to a particular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
(B) Additional time to be specifiedIn each declaration under paragraph (1), the Secretary, after consulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered countermeasure, shall also specify a date that is after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
(8) Preemption of State lawDuring the effective period of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
(A) In generalExcept 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—
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).
(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 under subsection (b), provided either the Secretary, or a State or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff’s alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person.
(A) In generalIf an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—
(B) DefinitionsFor purposes of this paragraph, the following terms have the following meanings:
The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title.
(ii) Covered remedyThe term “covered remedy” means an outcome—
that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal of an approval or clearance under chapter 5 [1] of such Act or of a licensure under section 262 of this title; and
(iii) FinalThe terms “final” and “finally”—
(i) In generalNothing in this paragraph shall be construed—
(3) Pleading with particularityIn an action under subsection (d), the complaint shall plead with particularity each element of the plaintiff’s claim, including—
(C) Materials requiredIn an action under subsection (d), the plaintiff shall file with the complaint—
(A) TimingIn an action under subsection (d), no discovery shall be allowed—
No provider of collateral source benefits shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of the plaintiff in an action under subsection (d).
(C) Collateral source benefit definedFor purposes of this paragraph, the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
In an action under subsection (d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term “noneconomic damages” means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
Whenever a district court of the United States determines that there has been a violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are responsible for the violation, an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the violation, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct.
(1) Covered countermeasureThe term “covered countermeasure” means—
a security countermeasure (as defined in section 247d–6b(c)(1)(B) of this title); or
a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
(2) Covered personThe term “covered person”, when used with respect to the administration or use of a covered countermeasure, means—
The term “distributor” means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
(4) ManufacturerThe term “manufacturer” includes—
The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department.
The term “program planner” means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b).
(7) Qualified pandemic or epidemic productThe term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),[2] biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) [2] that is—
(i) a product manufactured, used, designed, developed, modified, licensed, or procured—
the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or
(8) Qualified personThe term “qualified person”, when used with respect to the administration or use of a covered countermeasure, means—
a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
The term “security countermeasure” has the meaning given such term in section 247d–6b(c)(1)(B) of this title.
(10) Serious physical injuryThe term “serious physical injury” means an injury that—
(July 1, 1944, ch. 373, title III, § 319F–3, as added Pub. L. 109–148, div. C, § 2, Dec. 30, 2005, 119 Stat. 2818; amended Pub. L. 113–5, title IV, § 402(g)(2), (3), Mar. 13, 2013, 127 Stat. 196.)
[1]  So in original. Probably should be chapter “V”.
[2]  So in original. A third closing parenthesis probably should appear.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b)(8)(B), (c)(5)(A), (B)(i), (ii)(I), (C)(i), and (i)(7)(B)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. Chapter V of the Act is classified generally to subchapter V (§ 351 et seq.) of chapter 9 of Title 21. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
2013—Subsec. (i)(1)(C). Pub. L. 113–5, § 402(g)(3)(A), inserted “, 564A, or 564B” after “564”.
Subsec. (i)(7)(A)(iii). Pub. L. 113–5, § 402(g)(2), added cl. (iii).
Subsec. (i)(7)(B)(iii). Pub. L. 113–5, § 402(g)(3)(B), inserted “, 564A, or 564B” after “564”.