Vermont Supreme Court Ruling is a Threat to the Doctrine of Parent Informed Permission and Child Assent

Analysis of the decision shows a tone-deaf Vermont Supreme Court issuing anomalous decision that flies in the face of reason and elementary medical ethics.

The Vermont Supreme Court's recent decision to affirm a lower court's ruling that the state and the Windham Southeast Supervisory Union are immune from legal challenges brought by the parents of a child who was mistakenly vaccinated against their wishes raises significant concerns regarding informed consent and parental rights. This ruling has profound implications, suggesting that parents, without prior notification or solicitation by their child’s pediatrician, the school, or the state, must proactively send refusals of permission to vaccinate to schools. The reliance on unsolicited refusal of vaccination permission is a reversal of one hundred years of development of established norms, laws, and codes that demand that medical professionals obtain explicit informed consent from individual adults and informed permission from parents regarding their children.

Reversal of Informed Consent Principles

Informed consent is a foundational ethical principle in medical practice, requiring patients or their guardians to be fully informed about and voluntarily agree to medical procedures. This principle is especially crucial in the context of vaccinations, which are preventative measures administered to healthy individuals. The Vermont Supreme Court's decision effectively reverses this principle by placing the burden on parents to proactively send refusals of permission to schools. This approach undermines the ethical obligation of healthcare providers to ensure that patients or their guardians understand the risks, benefits, and alternatives before any medical intervention.

Legal and Ethical Standards

The requirement for informed consent is firmly established in federal regulations, including the Common Rule (45 CFR 46), which outlines ethical guidelines for research involving human subjects. The Common Rule includes special protections for vulnerable populations, such as children, ensuring that their participation in research is conducted ethically and with appropriate oversight. Specifically, 45 CFR 46.408 requires parental permission and child assent to be obtained before involving children in research. The Vermont ruling contravenes these protections by allowing vaccinations, which are continuously under long-term safety research, without explicit parental consent, raising serious ethical concerns.

Furthermore, the Common Rule (45 CFR 46.116) mandates that informed consent information must be presented to facilitate understanding and that the process must minimize the possibility of coercion or undue influence. By shifting the responsibility to parents to refuse consent, the Vermont ruling creates a coercive environment where the default assumption is consent unless actively refused, undermining the voluntary nature of informed consent.

Long-Term Safety and Ethical Concerns

Vaccines are continuously studied for their long-term safety, and it is critical that parents are fully informed about potential risks and benefits before consenting to their children's vaccination. The Vermont ruling not only bypasses this crucial aspect of informed consent but also implies that the state could enroll children in long-term vaccine safety studies without parental knowledge or consent. This scenario is ethically unacceptable and violates the principles of respect for persons and justice as outlined in the Belmont Report, which underpins ethical research practices.

Legal Precedents and Protections

The Vermont Supreme Court's decision starkly contrasts with recent other legal rulings that emphasize protecting individual rights and informed consent. For instance, in Medical Professionals for Informed Consent v. Bassett (2023), the New York State Supreme Court ruled against the state's COVID-19 “irrational” vaccine mandate for healthcare workers, citing the necessity of respecting individual rights and ensuring rational, evidence-based public health policies. Judge Gerard Neri emphasized that mandates must not override individual rights without proper legislative authority, highlighting the importance of informed consent.

Additionally, federal regulations like 45 CFR 46.101(b) and 45 CFR 46.402(a) provide explicit protections for children in research settings, ensuring that parental permission is obtained. By not adhering to these standards, the Vermont ruling sets a concerning precedent that could lead to ethical and legal violations in public health practices.

The Vermont Supreme Court's ruling represents a significant departure from established ethical and legal standards for informed consent. By requiring, by default, parents to proactively refuse permission, the ruling undermines the foundational principle that medical interventions should only proceed with explicit, informed consent. This decision jeopardizes parental rights, creates a coercive environment, and raises serious ethical concerns about enrolling children in long-term vaccine safety studies without parental knowledge or consent. It is imperative that this ruling be re-evaluated to align with ethical standards and legal protections designed to safeguard informed consent and protect vulnerable populations.

The Role of the PREP Act in the Vermont Supreme Court Decision

The Public Readiness and Emergency Preparedness (PREP) Act played a pivotal role in the Vermont Supreme Court's decision to affirm the lower court's ruling, which provided immunity to the state and the Windham Southeast Supervisory Union from legal challenges brought by parents whose child was mistakenly vaccinated against their wishes.

Overview of the PREP Act

The PREP Act, enacted in 2005, is designed to provide legal immunity to entities and individuals involved in administering countermeasures against public health emergencies. These countermeasures include vaccines, medications, devices, and other interventions intended to mitigate, prevent, or treat the effects of diseases or other health threats. The act grants immunity from liability claims arising from the use of these countermeasures, except in cases of willful misconduct.

Application in the Vermont Case

In the Vermont case, parents Dario and Shujen Politella sued the state and the school district after their child was mistakenly given a COVID-19 vaccine. They argued that the PREP Act should not provide blanket immunity in this situation, particularly since the issue stemmed from a procedural error (mix-up of name tags) rather than the administration of the vaccine itself.

However, the lower court and the Vermont Supreme Court concluded that the PREP Act provided immunity to state and school district employees. The courts reasoned that the actions the vaccination clinic workers took fell under the scope of administering countermeasures during a public health emergency, as defined by the PREP Act.

Key Legal Arguments and Court Rulings

Immunity Provision: The courts upheld that the PREP Act's broad immunity provision protected the state and the school district from liability. This provision is meant to encourage swift and decisive action during public health emergencies without fearing legal repercussions.

Public Health Emergency Response: The administration of the COVID-19 vaccine was considered a necessary countermeasure in response to the pandemic, thus falling squarely within the protections offered by the PREP Act.

Federal Preemption: The Vermont Supreme Court emphasized that when the PREP Act immunizes a defendant, it preempts state law claims against that defendant. This means that the federal law overrides any state-level legal challenges regarding administering covered countermeasures.

Procedural Error vs. Willful Misconduct: The plaintiffs argued that the mix-up was a result of negligence and should not be protected under the PREP Act. However, the courts found that the mistake did not constitute willful misconduct, which is the exception under the PREP Act. Therefore, the immunity still applied.

The use of the PREP Act, in this case, highlights the continuing conflict between public health policy and individual rights. It also means the Vermont Supreme Court is tone-deaf on the lack of efficacy of the vaccine at preventing transmission. The vaccine was not necessary, and thus, it could not, under any definition, have been a public health measure, and thus, it was not covered by the PREP Act.

While the Act aims to protect those who are executing necessary public health measures, it also raises concerns about accountability and the potential for procedural errors to go unaddressed.

Accountability: The ruling suggests that procedural errors made during the administration of vaccines in a public health emergency may be shielded from legal scrutiny, potentially limiting recourse for affected individuals.

Informed Consent: The case underscores the importance of maintaining rigorous informed consent processes, even during emergencies. The ruling may prompt further debate on how to balance the need for rapid public health responses with the protection of individual rights.

Future Policy Considerations: This case may lead to calls for more explicit guidelines on the application of the PREP Act, particularly in situations involving procedural errors and the rights of minors.

The PREP Act played a crucial role in the Vermont Supreme Court's decision, providing legal cover to the state and the school district by granting immunity from liability. This decision underscores the broad scope of the PREP Act in protecting public health efforts but ignores individual rights and the requirement of procedural safeguards in public health emergency responses.

We can expect the case to be appealed. The Supreme Court of the United States could then strike down the PREP Act as unconstitutional on any number of grounds.

Watch for another, more detailed article tomorrow morning.

For more detailed information on the PREP Act and its implications, you can refer to resources provided by the HHS Office of the Assistant Secretary for Preparedness and Response.