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PREP Act COVID 19 Liability Protections Continue Through HHS Amended Declaration

With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the...more

Appellate Decision Permits COVID-19 "Take-Home" Suit to Proceed

A California appeals court permitted a Los Angeles County wrongful death lawsuit for COVID-19 “take-home” liability to proceed. The plaintiff claims that plaintiff’s employer’s negligence resulted in plaintiff’s transmitting...more

PREP Act Preemption: “There is no COVID-19 Exception to Federalism”

When the estates of nursing home residents who died from COVID-19 brought negligence and wrongful death lawsuits in New Jersey state court, defendant nursing homes removed the suits to federal court under the Public Readiness...more

HHS Further Amends Declaration Under the PREP Act to Address Influenza and COVID-19 Impact and Add Pharmacist Vaccinators

The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more

Toll or Suspension? New York Appellate Division Provides Clarity

New York’s Appellate Division, Second Department recently denied two motions arguing an appeal was untimely where the appellant filed a notice of appeal nine days beyond the standard deadline. The appellant successfully...more

HHS Further Amends Declaration Under the PREP Act to Expand COVID-19 Vaccinators

The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures...more

FDA and FTC Take Action Regarding Pandemic-Related Products

In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...more

FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA

The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more

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

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

Government Issues Immunity to Liability for COVID-19 Countermeasures

In times of national public health crises such as the COVID-19 pandemic, manufacturers and distributors of products are often called to the frontlines of battle to create, supply, and administer the tools necessary to combat...more

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