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New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act's Defenses in Non-Use Situations | Seyfarth Shaw LLP


The US Department of Health and Human Services (“HHS”) issued an
Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete preemptive federal jurisdiction and invites jurisdictional discovery; and (2) applies to cases where the alleged harm results from failure to use (and even
refusal to use) a covered countermeasure when that failure arises out of the conscious allocation and prioritization of the countermeasures.
As we have
reported, the PREP Act, 42 U.S.C. § 247d-6d, affords broad federal immunity to a “covered person” with respect to claims relating to the authorized administration or use of a “covered countermeasure.” The scope of the federal immunity provided by the PREP Act is far-reaching. As a general matter, if all the elements of immunity are met, a covered person is protected from suit and liability under federal and state law with r ....

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HHS Expands and Clarifies Scope of Immunity under the PREP Act | Foley & Lardner LLP


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Back in March, we wrote about how the Department of Health and Human Services (HHS) had extended the Public Readiness and Emergency Preparedness (PREP) Act to grant immunity to “Covered Persons” providing “Covered Countermeasures” against COVID-19.  The Office of the General Counsel for HHS issued an omnibus advisory opinion on April 14 that addressed common questions and concerns about the scope of PREP Act immunity, as discussed in our April update.  Last month, we described how courts across the country have interpreted the PREP Act in the context of the ongoing pandemic. ....

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