The Public Readiness and Emergency Preparedness Act for Medical Countermeasures (“PREP ACT”) insulates vaccine manufacturers from liability, except for willful misconduct, under emergency circumstances. This immunity applies to claims for loss or harm from medical products, such as drugs or vaccines, which had been afforded “emergency use authorization” (EUA) by the FDA. It includes the COVID-19 Pfizer vaccines. [1] We’ve seen this provision shielding drug companies from claims for alleged vaccine-related harms. However, can the provision shield a government actor from compelling vaccination in a minor? In late March, the North Carolina Court of Appeals said yes.
The PREP Act was initially enacted to encourage manufacturers to develop novel epidemic countermeasures without fear of liability for developing a product that might be essential for national survival but of limited financial benefit to the developer, such as vaccines. But now, the Act has been used to protect local school boards (and their associates) administering those vaccines to unwilling recipients like Tanner Smith.
Tanner Smith (Happel) versus the Guilford County Board Of Education
Tanner is a regular 14-year-old football player who attends West Guilford High in Greensboro, North Carolina. On August 19, 2021, the Guilford County Schools informed Tanner’s Mom, Emily Happel, and his stepdad that football team members may have been exposed to a “recent COVID-19 cluster” and that the Health Department recommended COVID-19 testing for all potentially infected persons. Unless Tanner’s parents allowed the testing, they were informed students would not be allowed “to return to practice until cleared by a public health professional.”
Tanner’s stepdad drove him to the testing facility but remained outside. At the testing clinic, which was administering tests and vaccines, workers tried unsuccessfully to contact Tanner’s mother. So, against his verbal wishes, Tanner said he didn’t want the vaccine; they administered it anyway. There is no claim of physical restraint).
A year later, Tanner and his mother sued the Guilford County school board and Old North State Medical Society, which administered the shots, for battery, violations of Emily's state constitutional liberty, parental rights, and Tanner's bodily autonomy, and violation of Emily and Tanner’s federal constitutional rights.
In late March 2024, the North Carolina appeals court affirmed the lower court, ruling that the PREP Act barred the claim.
The PREP Act
“The purpose of the Pandemic and All-Hazards Preparedness Act is “to improve the Nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.”
The Act provides that when a determination is made that a disease, health condition, or threat to health constitutes a public health emergency, or that there is a credible risk that it will in the future constitute an emergency;
- the Secretary may make a “declaration” recommending “the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, such as development and distribution of drugs and vaccines, and
- those involved in these activities would be immune from liability and
- A fund would be created to compensate persons who proved to have suffered causally-related harm on a limited basis.
In January 2020, additions by former HHS Secretary Alex M. Azar declared
“…a public health emergency … for the entire United States to aid in the response of the nation's health care community to the COVID–19 outbreak.”
The immunity provisions of the Act are not automatically triggered by the declaration of a public health emergency, requiring the issuance of “a formal, separate Declaration … of enumerated “Covered Countermeasures.” Secretary Azar did issue that Declaration, including identifying Covered Countermeasures protecting “Covered Persons,” such as a “state or local government,” who are authorized to prescribe, dispense, and administer COVID–19 vaccines that are covered countermeasures under the Declaration.”
The Act explicitly recognized substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID–19 pandemic among federal, state, local, and private-sector entities.
Nevertheless, in 2021, North Carolina, like many states, amended its state law to require “parental consent before a vaccine granted emergency use authorization may be administered to a minor.”
That didn’t help Tanner Smith and his Mom – The North Carolina court held that the PREP Act preempts state and local law with contrary provisions:
“The statute remains explicitly subject to “any other provision of law to the contrary” under the broad provision preempting state law in the PREP Act.”
The Happel case is now the law in North Carolina. Other courts concur, affirming the priority of the national PREP Act over local regulations. For example, in November 2012, the New York Appellate Division held that a school nurse who inadvertently vaccinated a kindergartner without parental informed consent was protected by the Act and immune from suit. [2]
While the Act is intended to provide uniform standards and responses, superseding local regulations, various state laws are in conflict, notably the anti-masking provisions of Florida and anti-vaccine regulations of Texas. How federal courts – especially the arch-conservative Fifth Circuit (covering Alabama, Florida, Georgia, Texas, Louisiana, and Mississippi) will parse out the competing considerations should a new and dire wave of COVID, or any other disease envelop the nation, remains to be seen.
However, It will be difficult to decide the matter on partisan grounds. The PREP Act was initially enacted in 2005 under President George W. Bush. At that time, bio-terrorism drove the regulation. [3] The question is, does it matter whether the epidemic source is conceived by terrorists or by Mother Nature?
[1] The PREP Act sunsets on Oct. 1, 2024. For now, U.S.-based producers of COVID-19 vaccines covered by EUAs—are protected by complete immunity, except for willful violation or misconduct, as are those employing the vaccines. What happens to those using countermeasures already under FDA approval remains to be seen.
[2] Parker v. St. Lawrence County Public Health Department upheld PREP Act protections for a county that conducted a school-based vaccination clinic in response to the H1N1 outbreak.
[3] President Bush and VP Cheney, having suffered through the anthrax scare of 2001 (albeit in relative safety, reportedly given the then hard-to-procure antibiotic, Cipro, and sequestered in a safe location ‘far away from the vulnerable crowd’), were said to be highly agitated about the dangers of a contagious epidemic, and willing to sacrifice constitutional rights in the name of safety – unlike some leaders today.
