Preemption or Exception? The Pandemic Era Informed Consent Debate

In August 2024, the Vermont Supreme Court decided that a family could not sue a school district, superintendent, or school nurse after their child was accidentally given a COVID-19 vaccine without parental consent. The unauthorized vaccination occurred in 2021 in the Windham Southeast School District of Brattleboro, Vermont, during a vaccine clinic hosted by the Vermont Department of Health and the school district. Prior to the clinic, the student’s father expressed to an assistant principal that the plaintiffs did not consent to have L.P. vaccinated, and on the day of the clinic, the child “verbally protested,” saying, “Dad said no.” Nonetheless, the clinic workers administer one dose of the Pfizer-BioNTech COVID-19 vaccine. Based on these events, L.P.’s family filed an eight-count complaint in the civil division alleging negligence and battery. The defendants argued that they were immune from state-law claims under the PREP Act. 

The PREP Act, passed by Congress in 2005, authorizes the Secretary of the Department of Health and Human Services to specify the distribution or use of a “covered countermeasure”. During a public health emergency, “covered persons” are immune from all claims causally related to the administration of a covered countermeasure, and vaccines fall into that class. The Vermont Supreme Court decided that the defendants were “covered persons” under the PREP Act, so while the incident exhibited a lack of parental consent, those administering the vaccines were afforded legal protections. Ultimately, the case was dismissed.

In a similar case, the North Carolina Supreme Court concluded that the broad scope of immunity provided by the PREP Act applied to clinic workers at Northwest Guilford High School. In August 2021, Brett Happel drove his fourteen-year-old stepson, Tanner Happel, to a testing site at Northwest Guilford High School after receiving a notification of possible exposure. The Happels also received a letter stating that unless parents allowed their children to be tested, student-athletes could not return to practice until cleared by a public health professional. Tanner Happel was seated in the testing facility when a clinic worker tried unsuccessfully to contact Happel’s mother and obtain consent to administer a COVID-19 vaccine to him. After failing to make contact, a worker was instructed to “give it to him anyway.” Despite Happel stating that he did not want the procedure, a clinic worker administered a Pfizer COVID-19 vaccine. 

As medical care becomes increasingly complex, practical dimensions of informed consent fall under heightened scrutiny. Requirements for informed consent may change after Congressional regulations pass and vary under different jurisdictions. Under the legal doctrine of informed consent, patients have the right to make informed and voluntary treatment decisions. This ensures that the patient is fully informed about a procedure’s nature, risks, and alternative treatments. A patient can refuse or withdraw consent at any time during treatment, but informed consent promotes trust in the patient-provider relationship.

Some online claims falsely suggest that the Vermont ruling permits vaccinations without parental consent, which is not true. However, the Vermont Supreme Court case has sparked debates on government immunity and individual rights in both emergency and public healthcare policies. The Vermont case determined civil liability in the wake of a global health crisis. Contemporaneously, the case also raises serious questions about the scope of informed consent and government authority during public health emergencies. 

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