All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020.
We wrote previously on protections for certain face mask manufacturers and distributors that the Families First Coronavirus Response Act provided by amending the Public Health Service Act. The Act added “personal respiratory protective devices” to the list of covered countermeasures, which includes drugs, biological products, and medical devices, used in the COVID-19 public health response. To qualify as a personal respiratory protective device, however, face masks had to meet three criteria: (1) be previously approved by NIOSH, (2) be the subject of an Emergency Use Authorization (“EUA”) by the Food and Drug Administration (“FDA”), and (3) be used during and for the COVID-19 pandemic response.
The Coronavirus Aid, Relief, and Economic Security Act (“CARES”) Act essentially removed this amendment, replacing it with a broader addition to the covered countermeasure definition of any “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 319.” Thus, the CARES Act removed the requirement that the NIOSH-approved respirators also be subject to an FDA EUA to qualify for PREP Act immunity.
Through the amended PREP Act declaration, HHS effectively included all NIOSH-approved respirators in the pool of covered countermeasures, regardless of whether they also are intended for medical purposes. The other requirements for PREP Act immunity still apply (such as being a “covered person,” distributing the products through federal, state, or local public health responses, and others).
Companies understandably have had a difficult time in recent weeks determining which face masks and other products are covered by PREP Act immunity. The FDA has issued a string of EUAs since the start of the pandemic, including one for NIOSH-approved respirators, and another for respirators from China not previously approved by the FDA or NIOSH, creating even more confusion about which respirators qualify for immunity. HHS Office of General Counsel responded to an apparent flood of inquiries by issuing an advisory opinion on April 14, 2020 regarding PREP Act application. It is general in nature, but it includes a somewhat forgiving interpretation of immunity eligibility:
Given the broad scope of PREP Act immunity, Congress did not intend to impose a strict-liability standard on covered persons for determining whether a product is a covered countermeasure. Instead, we believe that a person or entity that otherwise meets the requirements for PREP Act immunity will not lose that immunity—even if the product is not a covered countermeasure—if that person or entity reasonably could have believed that the product was a covered countermeasure.
The advisory opinion contains a similar statement regarding covered persons determinations under the PREP Act. This opinion does not have the force of law but may give contractors some welcome comfort in interpreting what constitutes covered countermeasures and covered persons, and allay concerns about unwittingly procuring counterfeit devices. The opinion also links to a consolidated list, current through April 16, 2020, of all products currently subject to an EUA in the COVID-19 response effort.
The advisory opinion and amended PREP Act declaration are only the most recent developments in PREP Act coverage for the COVID-19 response. It is important for companies, particularly government contractors, to stay apprised of changes that can have a profound impact on business opportunities and legal risks. If your company needs help sorting through the steady stream of EUAs, declarations, and new legislation, Sheppard Mullin’s Coronavirus Insights Portal is a great place to start.
