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Immunity under Public Readiness and Emergency Preparedness Act (PREP Act)


September 16, 2021 by Tom Roberts, Esq.

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

  • of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
  • determined by the Secretary to constitute a present, or credible risk of a future public health emergency
  • to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

Text from Public Readiness and Emergency Preparedness Act (PREP Act)

The Act states in pertinent part

‘‘(1) IN GENERAL.—Subject to the other provisions of this section, 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”

Immunity does not apply to "Willful Misconduct"

‘‘(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‘

 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.

Suits ONLY in US District Court for District of Columbia...

‘‘(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

The PREP Act states that the actions of the Secretary of Health and Human Services under this act is not subject to judicial review!

‘(7) JUDICIAL REVIEW.—No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection”

 In Marbury v. Madison, the U.S. Supreme Court struck down an act of Congress as unconstitutional, Chief Justice John Marshall (a Virginian) stated: “It is emphatically the duty of the Judicial Department to say what the law is. Those who apply the rule to particular cases must, of necessity, expound and interpret the rule. If two laws conflict with each other, the Court must decide on the operation of each.”  The power to declare laws unconstitutional has been deemed an implied power, derived from Article III and Article VI of the U.S. Constitution

Article III  §1 – in pertinent part states “The judicial power of the United States, shall be vested in one Supreme Court, and in such inferior courts as the Congress may from time to time ordain and establish.”

Article III  §2 – in pertinent part states

“The judicial power shall extend to all cases, in law and equity, arising under this Constitution, the laws of the United States, and treaties made, or which shall be made, under their authority;–to all cases affecting ambassadors, other public ministers and consuls;–to all cases of admiralty and maritime jurisdiction;–to controversies to which the United States shall be a party;–to controversies between two or more states;–between a state and citizens of another state;–between citizens of different states;–between citizens of the same state claiming lands under grants of different states, and between a state, or the citizens thereof, and foreign states, citizens or subjects.”


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