Happel v. Guilford Cty. Bd. of Educ.

899 S.E.2d 387

Emily HAPPEL, individually, Tanner Smith, a minor, and Emily Happel on behalf of Tanner Smith as his mother, Plaintiffs,

v.GUILFORD COUNTY BOARD OF EDUCATION and Old North State Medical Society, Inc., Defendants.

No. COA23-487

Court of Appeals of North Carolina.

Filed March 5, 2024

West Codenotes

Preempted

N.C. Gen. Stat. Ann. § 90-21.5(a1)

Appeal by Plaintiffs from an order entered 1 March 2023 by Judge Lora C. Cubbage in Guilford County Superior Court. Heard in the Court of Appeals 28 November 2023. Guilford County, No. 22 CVS 7024

Walker Kiger, PLLC, by David Steven Walker, for Plaintiffs-Appellants.

Tharrington Smith, LLP, by Stephen G. Rawson, for Guilford County Board of Education, Defendants-Appellees.

Rossabi Law Partners, by Gavin J. Reardon, Greensboro, and Amiel J. Rossabi, for Old North State Medical Society, Inc., Defendants-Appellees.

WOOD, Judge.

Tanner Smith ("Tanner") and his mother, Emily Happel ("Emily") (collectively, the "Plaintiffs") appeal the trial court’s dismissal of their claims against the Guilford County Board of Education (the "Board") and Old North State Medical Society, Inc. ("ONS Medical Society") (collectively, the "Defendants") based on, among other things, statutory immunity under the federal Public Readiness and Emergency Preparedness Act ("PREP Act"). After careful review of the relevant statutes and case law, we affirm the trial court’s order.

I. Factual and Procedural History

On 14 August 2021, Tanner was fourteen years old and a football player at Western Guilford High School, a school within the Guilford County Schools system. By letter dated 19 August 2021, Guilford County Schools informed Emily and Brett Happel ("Brett"), Tanner’s stepfather, that Tanner may have been affected by a "recent COVID-19 cluster" involving football team members at his school, and that the Guilford County Public Health Department recommended and requested COVID-19 testing for individuals potentially infected, regardless of vaccination status. The letter stated that unless parents allowed their children to be tested, Guilford County Schools would not allow players "to return to practice until cleared by a public health professional." The letter further stated that COVID-19 testing would be available on 20 August 2021 at no cost at Northwest Guilford High School. The letter indicated ONS Medical Society would conduct the testing and "consent for testing is required."

On 20 August 2021, Brett drove Tanner to the testing site at Northwest Guilford High School. Brett remained inside his vehicle while Tanner went into the testing facility, which was also a COVID-19 vaccination site.

Inside, clinic workers gave Tanner a form to fill out, which he believed to be something related to the COVID-19 test. Tanner was seated in the facility while a clinic worker tried unsuccessfully to call Emily to obtain consent to administer a COVID-19 vaccine to him. The workers did not attempt to contact Brett. After failing to make contact with Tanner’s mother, one of the workers instructed the other worker to "give it to him anyway." Tanner stated he did not want a vaccine and was only expecting a test, but one of the workers administered a Pfizer COVID-19 vaccine to him.

Plaintiffs initiated this lawsuit on 19 August 2022, alleging three causes of action: (1) battery; (2) violations of Emily’s constitutional liberty and parental rights and of Tanner’s bodily autonomy rights under N.C. Const. art. I, §§ 1, 13, and 19; and (3) violations of both of Plaintiffs’ federal constitutional rights.¹ On 21 November 2022, the Board filed its answer, a motion to dismiss pursuant to Rules 12(b)(1) and (6), and a cross-claim against ONS Medical Society. On 30 December 2022, ONS Medical Society filed its answer and a motion to dismiss pursuant to Rules 12(b)(1) and (6).

The trial court held a hearing on 30 January 2023 and filed its written order on 1 March 2023 dismissing Plaintiffs’ complaint as to both Defendants. On 9 March 2023, Plaintiffs filed timely written notice of appeal pursuant to N.C. Gen. Stat. § 7A-27(b) (2022).

II. Analysis

Plaintiffs argue the trial court erred in determining that the PREP Act, which is codified at 42 U.S.C. § 247d-6d (addressing liability immunity) is applicable to this case and provides immunity to both Defendants. Due to the sweeping breadth of the federal liability immunity provision in the PREP Act, we are constrained to disagree.

[1] We review "a trial court’s decision to grant or deny a motion to dismiss based upon the doctrine of governmental or legislative immunity … de novo." Providence Volunteer Fire Dep’t, Inc. v. Town of Weddington, 382 N.C. 199, 209, 876 S.E.2d 453, 460 (2022).

Our state law requires that "a health care provider shall obtain written consent from a parent or legal guardian prior to administering any vaccine that has been granted emergency use authorization and is not yet fully approved by the United States Food and Drug Administration to an individual under 18 years of age." N.C. Gen. Stat. § 90-21.5(a1) (2021).

Enacted 30 December 2005, the PREP Act' provides that when the Secretary of Health and Human Services (the "Secretary") "makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency," the Secretary may make a "declaration" recommending "the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures." 42 U.S.C. § 247d-6d(b)(1). Additionally, the Secretary may declare that the provisions of subsection (a) apply "to the activities so recommended." Id. Subsection (a), in turn, provides liability immunity:

Subject to the other provisions of this section, a covered person shall be immune 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 if a declaration under subsection (b) has been issued with respect to such countermeasure.

42 U.S.C. § 247d-6d(a)(1) (emphasis added).

As for the scope of liability immunity, the PREP Act defines loss in the following manner:

For purposes of this section, the term "loss" means any type of loss, including—

(i) death;

(ii) physical, mental, or emotional injury, illness, disability, or condition;

(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and

(iv) loss of or damage to property, including business interruption loss.

42 U.S.C. § 247d-6d(a)(2)(A) (emphasis added). The PREP Act defines the scope of such immunity as follows:

The immunity … applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.

42 U.S.C. § 247d-6d(a)(2)(B) (emphasis added). "[T]he sole exception to the immunity from suit and liability of covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct." 42 U.S.C. § 247d-6d(d)(1).

Additionally, we must consider two more definitions under 42 U.S.C. § 247d-6d. The PREP Act defines covered person, "when used with respect to the administration or use of a covered countermeasure," as the following:

(A) the United States; or

(B) a person or entity that is—

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;

(iii) a program planner of such countermeasure;

(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

42 U.S.C. § 247d-6d(i)(2). A covered countermeasure includes a drug, biological product, or device that is authorized for emergency use. 42 U.S.C. § 247d-6d(i)(1).

Finally, the PREP Act contains a broad provision preempting state law, which states:

During the effective period of a declaration under subsection (b) of this section, or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter.

42 U.S.C. § 247d-6d(b)(8).

On 17 March 2020, in response to COVID-19, the Secretary issued a declaration pursuant to 42 U.S.C. § 247d-6d(b)(1) recommending the use of covered countermeasures, defined as "any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19." Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198-01, 15,202. The declaration provides guidance on who is a covered person under the PREP Act:

The PREP Act

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