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 respect to “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”

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