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Ex. DUT-FED-025 Standing duty Primary source read

42 U.S.C. 247d-6d (PREP Act targeted liability protections)

Targeted liability protections for pandemic and epidemic products and security countermeasures

Congress (Public Readiness and Emergency Preparedness Act, Pub. L. 109-148, div. C, § 2 (2005), as amended by the CARES Act § 3103) · United States (Federal)

The COVID Project

The record

Jurisdiction
United States
Level
Federal
Authority
42 U.S.C. 247d-6d(a), (b), (c), (i)
Issued
2005-12-30 Dec. 30, 2005
Effective
standing; operative for COVID-19 from Feb. 4, 2020 under the Declaration (Ex. FED-180) (read as 2020-02-04)
End
standing (read as 2021-09-30)
In force
Standing since Feb. 4, 2020 (a statutory duty; in force throughout the six quarters)
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Standing dutyOther
Addressees
  • covered persons: manufacturers, distributors, program planners (including private employers and community groups), qualified persons
Character
liability shield condition
Collection
Standing duties: Federal layer DUT-FED

Operative words

(a)(1)... a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.... (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...; (B) the countermeasure was administered or used for the category or categories of diseases... 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... (c)(1)(A)... the term 'willful misconduct' shall... 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...

Penalty

loss of immunity when the conditions are not met

What it required

Federal immunity for a 'program planner' (including a private employer under the Declaration's definition, Ex. FED-180) for the use of covered countermeasures (NIOSH-approved respirators, authorized tests and vaccines) applied 'only if' the use was within the declared period, disease, population and area, and under Section VII of the Declaration only for activities 'authorized in accordance with the public health and medical response of the Authority Having Jurisdiction'; compliance with the public-health authority's directives is therefore the condition of the federal shield. The exclusive remedy for death or serious injury is a willful-misconduct action in the District of Columbia (§ 247d-6d(d), (e)).

Retrieval note

The Declaration of March 10, 2020 (Ex. FED-180) and its amendments (Fourth, Ex. DUT-FED-027; Seventh, Ex. SEC-26-003) supply the conditions.