As concern about availability of personal protective equipment (“PPE”) continues to grow amid the COVID-19 pandemic, the federal government continues to take action aimed at increasing the availability of PPE with important implications for manufacturers and distributors of these products.
On April 15, 2020, the Department of Health and Safety (“HHS”) determined that National Institute of Health and Safety (“NIOSH”) approved respiratory devices are a “priority for use” during the COVID-19 pandemic and therefore amended its prior PREP Act Declaration specifically to include “any respiratory protective device approved by NIOSH” as a covered countermeasure for which an product manufacturer or distributor may be entitled to liability immunity. Manufacturers and suppliers of the qualified pandemic and/or epidemic products included in the original PREP Act Declaration may be entitled to liability immunity for the period of February 4, 2020 through October 1, 2024. Manufacturers of drugs and devices authorized for emergency use may be afforded immunity from the date the emergency declaration was issued through either the expiration of the emergency declaration, or October 1, 2024, whichever comes first.
The amended PREP Act Declaration states that, unless a NIOSH-approved device was distributed “in accordance with the public health and medical response of the” relevant governmental authority, the immunity period for manufacturers and distributors of NIOSH-approved masks and respirators does not begin until March 27, 2020. By the end of March 2020, the calls for increased production and distribution of PPE had been underway for weeks, with the World Health Organization’s call for a significant increase in PPE production as early as the beginning of March sparking a ramp-up in PPE production during March. Moreover, many entities and individuals had begun donating NIOSH-approved masks to healthcare facilities, first responders, and other essential workers prior to March 27; though many of these donations were made in accordance with public health response undertaken by governmental authorities, many such donations were also privately undertaken. As such, though legislation enacted by the federal government continues to provide immunity to manufacturers and suppliers of PPE and countermeasures, those in the supply chain for these critical products should continue to monitor amendments to legislation and the provisions that may grant and limit their immunity to liability.
In March of 2020 Congress had also extended the liability immunity that previously existed for manufacturers and distributors of FDA-approved or cleared masks to manufacturers and distributors of NIOSH approved masks and respirators. Our legal alert that provided an in-depth analysis of these legislative developments can be found here: https://www.harrisbeach.com/news/government-issues-immunity-to-liability-for-covid-19-countermeasures.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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