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Secretary of HHS Further Extends Immunity Under Public Readiness and Emergency Preparedness Act

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In March and April, we wrote about the protections afforded to health care providers and drug and medical device manufacturers in the form of tort immunity under the Public Readiness and Emergency Preparedness Act (“PREP Act”). The PREP Act provides sweeping immunity for certain types of claims against covered individuals administering so-called “Covered Countermeasures”—drugs and devices used to treat, diagnose, cure, prevent, or mitigate COVID-19. In this advisory, we discuss the latest changes enacted this month, which extend immunity to persons and activities not previously covered.

On December 3, 2020, the United States Department of Health and Human Services amended the March 10, 2020 Notice of Declaration first announcing immunity to those engaging in “activities related to medical countermeasures against COVID-19.” 42 U.S.C. 247d–6d (the “Amendment”). The Amendment contains several new provisions, extending immunity to additional Covered Persons and activities, including: (1) private sector activities related to the manufacture, administration, and distribution of Covered Countermeasures; (2) the non-administration of Covered Countermeasures; and (3) pharmacists and “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” (among others).

Private Sector Activities

The rationale for extending coverage to private activities is clear:

COVID-19 is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this pandemic, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels... 

Whereas immunity was previously available to private entities only when authorized by an Authority Having Jurisdiction (i.e., a federal, state, city, or local agency), coverage now applies to the private manufacture, testing, development, distribution, administration, or use of Covered Countermeasures that are:

  • Approved, licensed, or cleared by FDA;
  • Authorized under an Emergency Use Authorization (“EUA”);
  • Approved by NIOSH;
  • Described in an Emergency Use Instruction (“EUI”); or
  • Used under either an Investigational New Drug (“IND”) application or an Investigational Device Exemption.

Thus, facilities like nursing homes and private manufacturing plants are now immunized from liability in connection with their purely private activities. Amendment, § VII.

Non-Administration of Covered Countermeasures

The Amendment also clarifies that Covered Persons are immune from liability, even where no Covered Countermeasure is administered. In other words, claimants cannot bring suit against Covered Persons when injury is alleged to have resulted from the failure to administer a Covered Countermeasure. This allows health care workers to prioritize the use of Covered Countermeasures where supply is low, without fear of liability:

 [c]onsider a situation where there is only one dose of a COVID-19 vaccine, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional. In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to COVID-19. In that circumstance, the failure to administer the COVID-19 vaccine to the person in a less-vulnerable population ‘relat[es] to . . . the administration to’ the person in a vulnerable population.” 

The Secretary has thus determined that “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.” Amendment, § IX.

Pharmacists and Telehealth Personnel as Covered Persons

Given the recent announcements that a vaccine may be available in the United States before the end of the year, the Secretary’s amendment also addresses additional “Covered Persons” under the Act. Pharmacists administering vaccines and other Covered Countermeasures are now included among those who are covered by the Act.

Telemedicine is also now expressly included within the scope of PREP Act immunity, as an important part of the coordinated response to COVID-19. Because telehealth allows for social distancing and keeps those who may be contagious from further exposing others in health care facilities, it is a necessary part of fighting the virus. To that end, “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” are now considered Covered Persons under the Act and are immune from liability. Amendment, § V.

The sole exception to immunity under the PREP Act remains willful misconduct by Covered Persons. Accordingly, while the recent Amendment nearly forecloses liability associated with the treatment and prevention of COVID-19, the door is not completely shut to litigation for extreme examples that may be determined to fall under the “willful misconduct” exception.

We are monitoring this evolving situation and will keep you updated on future developments.

This advisory was prepared by Nutter’s Product Liability and Litigation Practice groups. For more information, please contact David Ferrera, Sarah Kelly or your Nutter attorney at 617.439.2000.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

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