The intersection of the PREP Act federal immunity statute and constitutional law continues to shape the landscape of COVID-19 vaccine litigation.  In Searcy v. Pfizer, Inc., __ F. Supp. 3d __, 2025 U.S. Dist. LEXIS 186682, 2025 WL 2713736 (M.D. Ala. Sept. 23, 2025), the Middle District of Alabama addressed a wrongful death action brought by the estate of a plaintiff who died following administration of a COVID-19 vaccine.  The estate asserted state law tort claims, and challenged the constitutionality of the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e.

As you may recall, the PREP Act was enacted to encourage rapid development and deployment of medical countermeasures during public health emergencies by providing broad immunity from suit and liability to “covered persons” for claims “caused by, arising out of, relating to, or resulting from” the administration or use of “covered countermeasures.”

The Act’s only exception is for willful misconduct, which is a claim that: (1) must be brought exclusively in the United States District Court for the District of Columbia;  (2) requires pleading with particularity and a complaint supported by a verification under oath, a doctor’s affidavit, and certified medical records; (3) requires conduct more culpable than negligence or recklessness; (4) can be pursued only after the plaintiff first pursues an administrative claim; and (5) must be proven by clear and convincing evidence.  42 U.S.C. §§ 247d-6d & 247d-6e.

The Act also establishes a no-fault administrative compensation program (the Countermeasures Injury Compensation Program, or “CICP”) for individuals allegedly injured by covered countermeasures.

The Lawsuit

The complaint alleged the decedent was “mandated, coerced, and fraudulently induced” to receive a COVID-19 vaccine as a condition of employment at a hospital (presumably one of the named health care defendants, although the complaint did not explicitly say), and that he died as a direct result of a “vaccine-induced condition” called spontaneous pneumothorax.  

The estate asserted twelve Alabama state law claims in Alabama state court, including wrongful death, failure to warn, negligence, fraud, and conspiracy, and sought both damages and a declaration that the PREP Act is unconstitutional.

But the complaint named a broad array of defendants—including vaccine manufacturers, healthcare providers, and federal officials—so the manufacturer removed.  Because of the federal defendants, 28 U.S.C. § 1442(a)(1) provided federal officer/federal agency jurisdiction, an unusual twist in our tort law world.

All of the defendants then filed motions to dismiss, asserting various arguments about PREP Act immunity, failure to state a claim, and the lack of merit to the estate’s asserted constitutional challenges.

PREP Act Immunity

The court found that all defendants were “covered persons” under the PREP Act, that COVID-19 vaccines are “covered countermeasures,” and that the estate’s claims arose from the administration of a covered countermeasure. To get there, the court had to address the estate’s challenge to the Department of Health & Human Services’ issuance of an Emergency Use Authorization (“EUA”) for the defendant manufacturer’s vaccine.  Issuance of an EUA is “committed to agency discretion” and such discretionary actions are exempt from review under the Administrative Procedures Act, however, so that pretty much was that.

The only real remaining out from PREP Act immunity was the willful misconduct exception, but the estate affirmatively disclaimed any willful misconduct argument.  The estate also argued that wrongful death claims are exempt from PREP Act immunity, but that isn’t in the statute so the court had little difficulty concluding that wrongful death claims are only permitted if they fit within the narrow willful misconduct exception.  

Constitutional Challenges

The battery of constitutional arguments, including alleged violations of procedural due process, the Takings Clause, the Seventh Amendment, the Commerce Clause, and the nondelegation doctrine, took a little more time to address, but the court applied the “presumption of constitutionality” due all federal statutes, and systematically rejected each challenge:

• Due Process: Congress’s legislative determination to provide immunity for certain state law claims afforded all the process that was due.   
• Takings Clause: Nobody has a protected property interest in any common-law rule, and the estate’s causes of action did not vest prior to the PREP Act’s enactment in any event.  So, no unconstitutional taking.
• Seventh Amendment:  Elimination of common-law claims does not violate the right to jury trial, nor do administratively-run compensation schemes like the CICP.
• Commerce Clause: Remember how the pandemic brought the economy to a screeching halt?  So yes, the PREP Act regulates economic activity that substantially affects interstate commerce.
• Nondelegation Doctrine and Separation of Powers: The PREP Act provides an intelligible principle to guide agency action and thus does not constitute an impermissible delegation of legislative authority.

And That’s Not All

Even if the PREP Act did not bar the claims, the court found that the federal defendants were entitled to sovereign immunity, as the Act expressly preserves such immunity and Congress did not unequivocally waive it.  

And product identification also required dismissal of the claims against the named vaccine manufacturer.  The complaint alleged that three COVID-19 vaccines were available, but never identified the one the decedent purportedly received, much less specify that it was the one manufactured by the manufacturer defendant it named.  

COVID-19 vaccines work, and we remain grateful for them and the other COVID-19 counter-measures developed by the life sciences industry during a harrowing world-wide crisis. Fortunately, Searcy further cements the PREP Act’s role as a shield for manufacturers, healthcare providers, and federal actors in the context of pandemic response.  We have added it to our PREP Act scorecard.