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We’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d.  That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures.  It was, as one of our colleagues put it, broad enough to cover a fight in the parking lot while waiting for drive-through COVID testing.

Well, COVID-19-related PREP Act tort immunity just got a whole lot bigger.

Yesterday, the Department of Health & Human Services (“HHS”) released a “Fourth Amendment” to the March Declaration, entitled innocuously enough, “Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 and Republication of the Declaration” (“Fourth Amendment”).  While we also looked for this in yesterday’s Federal Register, we didn’t find it (note:  it is now at 85 Fed. Reg. 79190 (HHS Dec. 9 2020).

In what appears to be HHS’s administrative response to the ongoing congressional deadlock over whether to create COVID-19 related immunity affecting the private sector, this Fourth Amendment undertakes to extend PREP Act immunity to a broad swath of purely private sector activities related to the administration, and in some cases the non-administration, of COVID counter measures.  The HHS summary states, among other things, that PREP Act immunity extends to:

  • “substantial federal legal and policy interests . . . [that require] a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.”
  • “situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration’s liability protections.”
  • “provide liability protections for, among other things, additional private-distribution channels”
  • “an additional category of Qualified Persons . . . [namely] healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.”

Fourth Amendment, Summary, at items c, f, g, h.

What does that mean?

As for what we do, litigation, to have a “uniform interpretation,” the Fourth Amendment expressly intends for there to be “an exclusive Federal cause of action”:

[T]here are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.  Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party’s exclusive remedy is an administrative remedy.

Fourth Amendment, at part XI (emphasis added).  Grable, as long-time blog readers know, is a Supreme Court decision finding federal subject matter jurisdiction over ostensibly state-law claims that “necessarily raise[]” “important” federal issues for which a federal forum was needed to “vindicate [federal] administrative action.”  514 U.S. at 314-15.  While Grable expected such situations to be “rare,” id. at 315, that is unlikely to be the case under the HHS Fourth Amendment.


Substantively, HHS has created an additional “pathway” for immunity that removes the prior prerequisite under the Declaration’s other Limitations on Distribution requiring that “covered persons” using on-label “Covered Countermeasures” being distributed under FDA auspices to combat COVID-19 have an agreement with the federal government.  The Fourth Amendment creates a “third distribution channel” allowing a Covered Person that manufactures, tests, develops, distributes, administers, or uses the Covered Countermeasure under FDA or NIOSH (for “respiratory devices”) auspices even though “there is no federal agreement or authorization.”  Fourth Amendment, at §VII.  A manufacturer, distributor, program planner, or qualified person that satisfies the other requirements of the PREP Act and prior HHS declarations, is immunized even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction.  Id.:

I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving:

  1. Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements;
  2. Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency; or
  3. Covered Countermeasures that are:
  4. licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or
  5. a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom.

To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

Fourth Amendment, Additional Amendments at VII.  Thus PREP Act immunity now extends to entities, such as nursing homes or manufacturing plants, acting in a purely private capacity, as long as they “manufacture, test, develop, distribute, administer, or use” Covered Countermeasures.  This extension of PREP Act immunity to purely private activities, if not entirely mooting the current congressional stalemate, appears to eliminate a large portion of the liability situations Congres has been debating.

The Fourth Amendment also broadens the definition of a PREP Act “Covered Person” to include not only pharmacists administering COVID vaccines, but “any person authorized . . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures.”  Fourth Amendment, Additional Amendments at V.  “Authorized” is nowhere limited by any requirement that the Covered Person actually have prescribed, administered, etc. a Covered Countermeasure.  Telemedicine is also now explicitly within the scope of PREP Act immunity.  Id. at V(e).

Also, remember those PREP Act cases we discussed that distinguished between the administration and non-administration of Covered Countermeasures?  The Fourth Amendment also broadens immunity to include non-administration situations where there is a “limited” supply of such countermeasures:

Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to . . . the administration to . . . an individual” under 42 U.S.C. 247d-6d. . . .  Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.

Fourth Amendment, Additional Amendments at IX.

Nor is PREP Act immunity limited to COVID-19 itself.  Part VIII of the Additional Amendments provides extends immunity to “other diseases, health conditions, or threats that may have been caused by COVID–19, . . . including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”

The Fourth Declaration also extends the immunity for “an additional 12 months,” until October 1, 2024, and defines causation under the PREP Act’s compensation program (the “Countermeasures Injury Compensation Program” or CICP) to require “compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation.”  Fourth Amendment, Additional Amendments, at XII-XIV.

There are many details in the Fourth Amendment that we have left out or glossed over.  As the footnotes to the Fourth Amendment indicate, there are also advisory opinions and guidances in addition to the original Declaration and, now, four amendments.  We recommend that anyone interested in the matters discussed in this blogpost read the Fourth Amendment for themselves or discuss it with their lawyers.