PREP Act Immunity Does Not Bar State Constitutional Claims

Introduction

The North Carolina Supreme Court’s decision in Happel v. Guilford County Board of Education (2025) arises from a disturbing incident during the COVID-19 pandemic in which a fourteen-year-old student, Tanner Smith, was injected with a vaccine by a school-sponsored clinic without his or his mother’s valid consent. Emily Happel (the mother) and Tanner Smith sued the Guilford County Board of Education and its medical partner, Old North State Medical Society, Inc. (“ONSMS”), for battery and for violation of their state constitutional rights to parental decision-making and bodily integrity. The defendants moved to dismiss, arguing that the federal Public Readiness and Emergency Preparedness Act (“PREP Act”) preempted all of the plaintiffs’ claims. The Supreme Court of North Carolina was asked to decide whether Congress, through the PREP Act, intended to preempt and immunize state actors from liability when they forcibly administer a covered vaccine without consent.

Key issues:

  • Does the PREP Act’s grant of immunity shield state‐law battery and state constitutional claims?
  • Does the PREP Act preempt claims for violation of fundamental rights under the North Carolina Constitution—namely, parental control and bodily integrity?
  • What is the scope of “loss” under the PREP Act’s immunity provision?

Parties:

  • Plaintiffs/Appellants: Emily Happel (individually and on behalf of her son, Tanner Smith)
  • Defendants/Appellees: Guilford County Board of Education; Old North State Medical Society, Inc.

Summary of the Judgment

By a 4–3 vote, the Supreme Court of North Carolina held:

  1. The PREP Act’s broad grant of immunity from “all claims for loss” caused by or relating to a covered countermeasure preempts state‐law tort claims such as battery.
  2. Under its plain text, “loss” is defined by the Act to include death, physical or emotional injury, and property damage—i.e., tort‐type injuries—not constitutional deprivations.
  3. Because the Act’s examples focus on tort claims, it does not extend immunity to state constitutional claims for violation of fundamental rights protected by the North Carolina Constitution’s Law of the Land Clause.
  4. The plaintiffs’ battery claim remains barred by PREP Act immunity, but their claims for violation of parental decision‐making and bodily integrity survive and must proceed.

Disposition:

  • Battery claim: Affirmed dismissal.
  • State constitutional claims: Reversed dismissal and remanded for further proceedings.

Analysis

Precedents Cited

  • Hudak v. Elmcroft of Sagamore Hills (6th Cir. 2023): Defined the PREP Act’s purpose “to encourage the development and deployment of medical countermeasures” and explained the role of the HHS Secretary’s declaration in triggering immunity.
  • Saldana v. Glenhaven Healthcare LLC (9th Cir. 2022): Held that the Secretary’s declaration “controls the scope” of immunity.
  • Parker v. St. Lawrence County Public Health Department (N.Y. App. Div. 2012): Pre-COVID case holding that the PREP Act barred negligence and battery claims against a nurse who vaccinated a minor without consent.
  • Cowen v. Walgreen Co. (N.D. Okla. 2022): Applied PREP Act immunity to a plaintiff who received a COVID-19 vaccine by mistake at a pharmacy.
  • M.T. ex rel. M.K. v. Walmart Stores, Inc. (Kan. Ct. App. 2023): Held the PREP Act preempted state‐law claims—including battery—of a minor vaccinated without parental consent, though no constitutional claims were raised there.
  • Politella v. Windham SE School District (Vt. 2024): Extended PREP Act immunity to tort and state constitutional claims in a similar school‐vaccination context (relied on by defendants but distinguished by this Court).

Legal Reasoning

The Court’s reasoning proceeds in three main steps:

  1. Interpretation of the PREP Act’s Immunity Clause.
    • The Act provides immunity “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…of a covered countermeasure.” (42 U.S.C. § 247d-6d(a)(1)).
    • “Loss” is explicitly defined to include tort‐type injuries: death, physical or emotional harm, fear of injury, property damage. (42 U.S.C. § 247d-6d(a)(2)(A)).
    • Because the examples are tort‐based, and the Act’s sole exception applies only to willful-misconduct torts causing death or serious injury, the immunity does not sweep in constitutional claims that lack a “tort‐type” loss.
  2. State Constitutional Rights Are Distinct from Tort Loss.
    • North Carolina’s Law of the Land Clause (Art. I, § 19) protects “life, liberty, and property” and is analogous to the federal Due Process Clause.
    • The Court recognized two fundamental rights implied by that Clause:
      1. Parental right to control the upbringing and medical decisions for one’s minor child.
      2. Right to bodily integrity: the liberty to refuse unwanted, nonmandatory medical treatment.
    • These constitutional rights—though often enforced through tort‐based concepts like battery—are not themselves “claims for loss” under the PREP Act’s definition.
  3. Federalism and Preemption Principles.
    • The Supremacy Clause (U.S. Const. Art. VI) requires enforcement of valid federal preemption clauses.
    • Where Congress enacts an express preemption clause—like § 247d-6d(b)(8)—courts apply its text according to ordinary principles of statutory interpretation, without resort to presumptions against preemption.
    • Because the PREP Act’s text clearly preempts “all claims for loss” causally related to covered countermeasures, it bars state‐law tort and any other state‐law claims seeking recovery for such losses.
    • State constitutional claims do not qualify as “claims for loss” because they seek redress for infringements of fundamental liberties rather than tort‐style injuries.

Impact

This decision has immediate and far-reaching consequences:

  • It clarifies that, under North Carolina law, the PREP Act preempts private tort suits against covered entities and officials who administer federally declared countermeasures.
  • It preserves the ability of North Carolinians to bring state constitutional claims—particularly for fundamental liberties—unaffected by PREP Act immunity.
  • Government actors and medical providers must still heed parental‐consent laws and respect bodily autonomy, or face constitutional litigation in state court.
  • Future disputes over medical countermeasures and emergency declarations will require careful parsing of whether a claim seeks damages for tort “loss” or vindicates constitutional rights.
  • The ruling reinforces the role of state constitutions in safeguarding individual liberties when federal statutes do not explicitly grant immunity for constitutional deprivations.

Complex Concepts Simplified

PREP Act Immunity
A federal law that grants doctors, manufacturers, and government officials immunity from lawsuits for injuries “caused by” or “relating to” vaccines and other countermeasures during a public health emergency.
Preemption
Under the Supremacy Clause, if a valid federal law conflicts with state law, the federal law overrides state law. An express preemption clause in a federal statute makes that override explicit.
“Claims for Loss”
The PREP Act defines “loss” to include tort‐style harms—death, injury, fear of injury, property damage—and only those claims that seek recovery for such harms fall under the Act’s immunity.
Law of the Land Clause
Article I, Section 19 of the North Carolina Constitution, guaranteeing that no one may be deprived of life, liberty, or property except by lawful process. It parallels the federal Due Process Clause.
Corum Claim
A state‐law cause of action for the violation of a right guaranteed by the North Carolina Constitution when no adequate statutory remedy exists.

Conclusion

Happel v. Guilford County Board of Education establishes a clear precedent in North Carolina:

  • The PREP Act preempts and immunizes covered entities from tort suits for harms caused by covered countermeasures during a declared public health emergency.
  • Federal immunity does not extend to state constitutional claims for violation of fundamental rights—parental decision‐making and bodily integrity—which remain fully actionable in our state courts.
  • State constitutions serve as vital safeguards of liberty, ensuring that federally immunized actors cannot escape accountability when they violate deeply rooted rights.

As emergencies arise, North Carolinians may still turn to their state courts to vindicate fundamental liberties, even while the PREP Act bars the recovery of tort‐style losses for covered vaccine administration.