News & Analysis as of

Distributors Public Readiness and Emergency Preparedness Act (PREP Act)

Patterson Belknap Webb & Tyler LLP

HHS Broadens Scope of PREP Act Immunity for Individuals and Entities Fighting COVID-19

On December 3, 2020, the Secretary of the Department of Health and Human Services issued a fourth amended PREP Act declaration expanding the scope of immunity for covered entities engaged in the provision of goods and...more

Pillsbury Winthrop Shaw Pittman LLP

The Limited Pandemic Federal Liability Protections

Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more

Sheppard Mullin Richter & Hampton LLP

Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19...more

Harris Beach PLLC

FDA’s Emergency Use Authorization Expands Class of Mask Manufacturers and Distributors Entitled to Immunity

Harris Beach PLLC on

In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more

Goodwin

Qualifying for Immunity Under the U.S. PREP Act During COVID-19

Goodwin on

As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more

Sheppard Mullin Richter & Hampton LLP

Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this...more

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