Author: Ruth Chi

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. 

Who Has Access to Unpaid Family and Medical Leave?

The Family and Medical Leave Act (FMLA) guarantees eligible employees up to 12 weeks of unpaid leave each year to care for a newborn, newly adopted child, and/or a seriously ill immediate family member, or to recover from their serious health condition. FMLA also provides up to 26 weeks of leave to care for a covered service member with a serious injury or illness. Signed into law by President Bill Clinton in 1993, the FMLA has since allowed millions of American workers to take time off without the risk of losing their jobs or health insurance.

While FMLA offers job-protected leave to many American workers, over 40 percent of the workforce remains ineligible. The FMLA applies only to employers with 50 or more employees, public agencies, and public schools. Employers must also provide group health insurance to meet the requirements of the Act. In general, eligible employees must have worked for the covered employer for at least 12 months, accrued at least 1,250 hours of service during the previous 12 months, and report physically to a worksite where at least 50 employees work within 75 miles.

The United States Department of Labor (DOL) Wage and Hour Division released guidance to address concerns regarding the physical worksite requirement. Before COVID-19, remote work was less common, but with digital jobs expected to increase by 25% globally over the next six years, concerns about FMLA eligibility for remote workers have grown. For FMLA eligibility purposes, an employee’s residence is not considered a worksite. Whether or not to include remote employees in FMLA coverage has raised questions for employers. In the 2023 Field Assistance Bulletin, the DOL clarified that an employee’s worksite for FMLA eligibility is the office to which they report or from which their assignments are made. This effectively limits remote workers’ access to protected leave under FMLA.

Another key concern regarding FMLA is whether certain health conditions, including mental health issues, qualify as “serious health conditions” under the Act. Generally, to meet the criteria, a health condition must involve inpatient care at a hospital or medical facility, incapacitating conditions requiring ongoing medical treatment, or childbirth. As of November 2024, the DOL Wage and Hour Division has concluded 349 FMLA compliance actions, with violations resulting in the recovery of more than $1.48 million in back wages for 344 affected employees. The most common FMLA violations include denial of leave, failure to reinstate employees to their same position or benefits, termination, and discrimination.

Access to FMLA is not equally distributed across the workforce. Many workers report returning from leave only to find their benefits have been canceled, or that their job or performance evaluations have changed. Racial, ethnic, and class disparities in access to and use of FMLA are increasingly being documented across the job market. Data from the National Compensation Survey shows that low-paid workers are less likely to have access to paid leave than higher-paid workers. Research by the United States Bureau of Labor Statistics also reveals that Hispanic workers have lower rates of paid leave access than their White non-Hispanic counterparts and that disparities in paid leave access also exist based on factors such as education and employment status. These disparities highlight key issues and opportunities for reform in the nation’s policy on unpaid leave for serious health conditions.