42 USC 247d-6d - Targeted liability protections for pandemic and epidemic products and security countermeasures

U.S Code last checked for updates: Nov 22, 2024

§ 247d–6d.

Targeted liability protections for pandemic and epidemic products and security countermeasures

(a)

Liability protections

(1)

In general

(2)

Scope of claims for loss

(A)

Loss

For purposes of this section, the term “loss” means any type of loss, including—

(i)

death;

(ii)

physical, mental, or emotional injury, illness, disability, or condition;

(iii)

fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and

(iv)

loss of or damage to property, including business interruption loss.

Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.

(B)

Scope

(3)

Certain conditions

Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—

(A)

the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;

(B)

the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and

(C)

in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—

(i)

was in a population specified by the declaration; and

(ii)

was at the time of administration physically present in a geographic area specified by the declaration or had a connection to such area specified in the declaration.

(4)

Applicability of certain conditions

With respect to immunity under paragraph (1) and subject to the other provisions of this section:

(A)

In the case of a covered person who is a manufacturer or distributor of the covered countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in paragraph (3)(C).

(B)

In the case of a covered person who is a program planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in paragraph (3)(C).

(5)

Effect of distribution method

(6)

Rebuttable presumption

(b)

Declaration by Secretary

(1)

Authority to issue declaration

(2)

Contents

In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered countermeasure specified in the declaration—

(A)

the category or categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure;

(B)

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);

(C)

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);

(D)

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

(E)

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.

(3)

Effective period of declaration

(A)

Flexibility of period

(B)

Additional time to be specified

In 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—

(i)

a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return of such product to the manufacturer; and

(ii)

a reasonable period for covered persons to take such other actions as may be appropriate to limit administration or use of the covered countermeasure.

(C)

Additional period for certain strategic national stockpile countermeasures

(4)

Amendments to declaration

(5)

Certain disclosures

(6)

Factors to be considered

(7)

Judicial review

(8)

Preemption of State law

During 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)

is different from, or is in conflict with, any requirement applicable under this section; and

(B)

relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(9)

Report to Congress

(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

(2)

Authority to promulgate regulatory definition

(A)

In general

(B)

Factors to be considered

(C)

Temporal scope of regulations

(D)

Initial rulemaking

(3)

Proof of willful misconduct

(4)

Defense for acts or omissions taken pursuant to Secretary’s declaration

(5)

Exclusion for regulated activity of manufacturer or distributor

(A)

In general

If 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—

(i)

neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or

(ii)

such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.

Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action.

(B)

Definitions

For purposes of this paragraph, the following terms have the following meanings:

(i)

Enforcement action

(ii)

Covered remedy

The term “covered remedy” means an outcome—

(I)

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

 So in original. Probably should be chapter “V”.

of such Act or of a licensure under section 262 of this title; and

(II)

that results from a final determination by a court or from a final agency action.

(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 [21 U.S.C. 301 et seq.], of this chapter, 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 chapter, under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], under title 18, or under any other applicable statute or regulation.

(ii)

Mandatory recalls

(d)

Exception to immunity of covered persons

(1)

In general

(2)

Persons who can sue

(e)

Procedures for suit

(1)

Exclusive Federal jurisdiction

(2)

Governing law

(3)

Pleading with particularity

In an action under subsection (d), the complaint shall plead with particularity each element of the plaintiff’s claim, including—

(A)

each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed;

(B)

facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and

(C)

facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or serious physical injury.

(4)

Verification, certification, and medical records

(A)

In general

(B)

Verification requirement

(i)

In general

(ii)

Identification of matters alleged upon information and belief

(C)

Materials required

In an action under subsection (d), the plaintiff shall file with the complaint—

(i)

an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physician’s belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered countermeasure; and

(ii)

certified medical records documenting such injury or death and such proximate causal connection.

(5)

Three-judge court

(6)

Civil discovery

(A)

Timing

In an action under subsection (d), no discovery shall be allowed—

(i)

before each covered person sued has had a reasonable opportunity to file a motion to dismiss;

(ii)

in the event such a motion is filed, before the court has ruled on such motion; and

(iii)

in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.

(B)

Standard

(7)

Reduction in award of damages for collateral source benefits

(A)

In general

(B)

Provider of collateral source benefits not to have lien or subrogation

(C)

Collateral source benefit defined

For 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—

(i)

any State or Federal health, sickness, income-disability, accident, or workers’ compensation law;

(ii)

any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;

(iii)

any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; or

(iv)

any other publicly or privately funded program.

(8)

Noneconomic damages

(9)

Rule 11 sanctions

(10)

Interlocutory appeal

(f)

Actions by and against the United States

(g)

Severability

(h)

Rule of construction concerning National Vaccine Injury Compensation Program

(i)

Definitions

In this section:

(1)

Covered countermeasure

The term “covered countermeasure” means—

(A)

a qualified pandemic or epidemic product (as defined in paragraph (7));

(B)

a security countermeasure (as defined in section 247d–6b(c)(1)(B) of this title);

(C)

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]; or

(D)

a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under section 247d of this title.

(2)

Covered person

The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means—

(A)

the United States; or

(B)

a person or entity that is—

(i)

a manufacturer of such countermeasure;

(ii)

a distributor of such countermeasure;

(iii)

a program planner of such countermeasure;

(iv)

a qualified person who prescribed, administered, or dispensed such countermeasure; or

(v)

an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

(3)

Distributor

(4)

Manufacturer

The term “manufacturer” includes—

(A)

a contractor or subcontractor of a manufacturer;

(B)

a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and

(C)

any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

(5)

Person

(6)

Program planner

(7)

Qualified pandemic or epidemic product

The 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

 So in original. A third closing parenthesis probably should appear.

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—

(A)

(i)

a product manufactured, used, designed, developed, modified, licensed, or procured—

(I)

to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or

(II)

to limit the harm such pandemic or epidemic might otherwise cause;

(ii)

a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or

(iii)

a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and

(B)

(i)

approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;

(ii)

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

(iii)

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].

(8)

Qualified person

The term “qualified person”, when used with respect to the administration or use of a covered countermeasure, means—

(A)

a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or

(B)

a person within a category of persons so identified in a declaration by the Secretary under subsection (b).

(9)

Security countermeasure

(10)

Serious physical injury

The term “serious physical injury” means an injury that—

(A)

is life threatening;

(B)

results in permanent impairment of a body function or permanent damage to a body structure; or

(C)

necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

(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; Pub. L. 116–127, div. F, § 6005, Mar. 18, 2020, 134 Stat. 207; Pub. L. 116–136, div. A, title III, § 3103, Mar. 27, 2020, 134 Stat. 361.)

cite as: 42 USC 247d-6d

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