Product Liability & Mass Torts Digest
Sort by:
8 results
February 5, 2021
|2 min read
Amendment to PREP Act Declaration Expands Pool of Vaccinators
Effective January 28, 2021, the acting secretary of the Department of Health and Human Services (HHS) amended the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19.
December 11, 2020
|4 min read
HHS Issues Fourth Amendment to PREP Act COVID-19 Declaration
On December 3, 2020, the Department of Health and Human Services (HHS) issued an expansive Fourth Amendment to its original Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19.
August 27, 2020
|3 min read
Third Amendment to PREP Act Declaration Expands Scope of COVID-19 Liability Immunity
On August 24, 2020, the Secretary for the Department of Health and Human Services (HHS) issued a Third Amendment to the March 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for medical countermeasures against COVID-19.
August 21, 2020
|2 min read
FDA Premarket Review/Authorization No Longer Needed for COVID-19 Laboratory Developed Tests
On August 19, 2020, the Department of Health and Human Services (HHS) rescinded prior guidance and “other informal issuances” concerning premarket review and authorization of laboratory developed tests “LDTs) for COVID-19 and “future pandemics.”
June 17, 2020
|3 min read
Amended PREP Act Declaration Clarifies Products Used to “Limit the Harm” from COVID-19
On June 4, 2020, the Secretary for the Department of Health and Human Services (HHS) issued a Second Amendment to the March 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for medical countermeasures against COVID-19.
June 16, 2020
|4 min read
States Expand COVID-19-Related Immunity and Provide Guidance to Businesses Reopening
Along with the expansive tort liability immunity offered by the recent Declaration of the Secretary of the Department of Health and Human Services (HHS), several states continue to expand immunity from liability for businesses and manufacturers during the COVID-19 pandemic.
June 15, 2020
|4 min read
HHS Advisory Opinion on Immunity under the PREP Act
As manufacturers and distributors of COVID-19 products respond to the pandemic, on April 14, 2020, the General Counsel for the Department of Health & Human Services (“HHS”) issued an Advisory Opinion in response to numerous requests for more clarity on the scope of immunity from tort and contract claims under the Public Readiness and Emergency Preparedness Act (“PREP Act”).
June 15, 2020
|3 min read
HHS Advisory Opinion Regarding Pharmacists’ Abilities to Order and Administer COVID-19 Tests
To provide guidance to pharmacists seeking to understand whether they may order and administer COVID-19 diagnostic tests under the PREP Act, even in states restricting them from doing so, the Department of Health and Human Services (HHS) issued an Advisory Opinion on May 19, 2020. The HHS concluded that the PREP Act preempts state and local requirements prohibiting a pharmacist from ordering and administering authorized COVID-19 tests.
About This Blog
Winston & Strawn’s Product Liability & Mass Torts Digest provides updates, insights, and practical tips on a full spectrum of issues related to product liability and mass torts litigation.
