Liability Immunity Now Extended to Manufacturers of Any NIOSH-Approved Respirator Used as a COVID-19 Countermeasure, Including Those Not Intended for Medical Applications
As the COVID-19 pandemic stresses the U.S. health care system, personal protective equipment such as personal respirators are in desperately short supply. Healthcare providers are repurposing respirators originally designed for non-medical use to combat the COVID-19 pandemic. This practice raises the question as to whether manufacturers of non-medical respirators qualify for liability immunity under the Public Readiness and Emergency Preparedness Act (PREPA).
We previously wrote about PREPA and the March 17, 2020 declaration by the Secretary of Health and Human Services providing liability immunity to manufacturers for any claim under federal or state law for damage “caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a Covered Countermeasure” used to treat, diagnose, cure, prevent, or mitigate COVID-19. The definition of “Covered Countermeasure” included medical devices, pharmaceuticals and biologics approved by the FDA. However, many NIOSH-approved respirators are not approved by the FDA as medical devices because they are not intended for medical applications.
This appeared to be part of the hesitation by 3M, when it backed off of a promise to ramp up production of N95 respirators by repurposing respirators originally designed for the construction industry. In response to 3M’s concerns, Congress first extended legal immunity to manufacturers of respirators on March 18, 2020. The Families First Coronavirus Response Act, H.R. 6201, amended PREPA to add respirators to the list of covered countermeasures so long as they are NIOSH-approved and subject to an Emergency Use Authorization (EUA) by the FDA. Even with this Congressional amendment, it remained questionable whether a manufacturer of non-medical respirators qualified for liability immunity under PREPA. The FDA was continuously updating EUAs, which included respirators imported from China, Japan and Turkey that were not approved by NIOSH or the FDA. This prompted Congress to provide some clarity regarding which respirators were covered countermeasures.
The Coronavirus Aid, Relief, and Economic Security Act H.R. 748, (CARES Act) removed the EUA requirement by expanding the definition of covered countermeasures to include “any respiratory protective device” approved by NIOSH if “HHS declares the respirator to be a priority for use during a declared public health emergency.” This was immediately followed up by the April 15, 2020 declaration by the Secretary of HHS to include “any respiratory protective device” approved by NIOSH to the covered countermeasures eligible for PREPA immunity, retroactive to March 27, 2020.
The CARES Act and the April 15, 2020 declaration by the Secretary is one of many actions taken to increase protections for manufacturers. If you are not sure whether or not your company is immune, please reach out to us for advice to assess these risks.