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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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