The application of the PREP Act is being more actively litigated now than ever before because of the pandemic. An unresolved question is whether the PREP Act provides protection to companies and their executives who are sued in shareholder class action suits.
MAJOR MARKET COMPARISON OF KEY COVID-19 LEGISLATION
As pharmaceutical companies worldwide race to supply vaccines
and therapeutics to fight the spread of COVID-19, understanding the
laws and regulations that could impact parties involved in the
COVID-19 pandemic supply chain is increasingly important. This
article provides an overview and comparison of legislation relevant
to manufacturers, suppliers, distributors, and health professionals
involved in the response to the COVID-19 pandemic in each of the
United States ( US ), European Union ( EU ),
United Kingdom ( UK ), and People s Republic of China
( PRC ), including measures to ensure (1) immunity from
COVID-19 countermeasure liability; (2) government ability to direct
(or redirect) resources; (3) emergency use authorizations; (4)
[co-author: Genta Iwasaki]
In a February 10, 2021 ruling (the “Garcia Ruling”) out of the District Court for the Central District of California (the “CDCA Court”) in the case of
., 20-02250JVS (C.D. Ca. Feb. 10, 2021), the CDCA Court held that the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d–6d) (the “PREP Act”) provides senior living facilities with an exemption from civil liability for actions taken by such facilities to protect facility residents from COVID-19.
Given that long-term care and senior living facilities have experienced a disproportionate share of COVID-19 cases and deaths nationwide during the pandemic,[1] with many states having experienced their worst COVID-19 outbreaks and highest number of deaths in long-term care facilities in December 2020,[2] the extension of PREP Act liability protections to senior and long term care facilities is tremendously significant to the industry.
Senior Living Communities, Liability for COVID-19 Countermeasures, and the PREP Act: Is the Tide Turning for Providers? Monday, March 8, 2021
In a February 10, 2021 ruling (the “Garcia Ruling”) out of the CDCA Court for the Central District of California (the “CDCA Court”) in the case of
., 20-02250JVS (C.D. Ca. Feb. 10, 2021), the CDCA Court held that the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d–6d) (the “PREP Act”) provides senior living facilities with an exemption from civil liability for actions taken by such facilities to protect facility residents from COVID-19.
Given that long-term care and senior living facilities have experienced a disproportionate share of COVID-19 cases and deaths nationwide during the pandemic,[1] with many states having experienced their worst COVID-19 outbreaks and highest number of deaths in long-term care facilities in December 2020,[2] the extension of PREP Act liability protections to senio
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On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment[1] to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19 (the “Declaration”), entitled “Fifth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 and Republication of the Declaration” (hereinafter the “Fifth Amendment”).[2] This latest amendment adds additional categories of qualified persons authorized to prescribe, dispense and administer FDA-authorized, approved, or licensed COVID-19 vaccines in an effort to help states and U.S. territories “meet the demand for vaccines and protect their communities as quickly as possible” as vaccine supply becomes more widely available.[3] In turn, where the applicable requirements have been met (and subject to certain limi