Ms. P, aged 41 years, was a nurse practitioner working for the public-health department in a mid-sized county in a northeastern state. In 2009, she had been working at her current job for five years, and found her responsibilities to be an interesting mix of public-health initiatives.
That fall, a serious outbreak of the H1N1 influenza (swine flu) virus began surfacing. In response to the spate of H1N1 occurrences, the Secretary of Health and Human Services, pursuant to the federal Public Readiness and Emergency Preparedness (PREP) Act, declared that a public-health emergency existed and recommended administration of the antiviral vaccination peramivir.
In response to the Secretary’s declaration, the governor of the state issued an executive order authorizing state and local health departments to establish immunization programs to facilitate the timely distribution and administration of the H1N1 vaccine.
The public-health department for which Ms. P worked sprang into action. Various immunization clinics—from schools to senior centers—were set up, and all the public-health nurses were sent out to staff the clinics. Ms. P was assigned to run a clinic operating out of an elementary school. Notices and consent forms were sent to parents in the days leading up to the immunization.
Ms. P spent almost a full school week in the health office immunizing a steady stream of children who were brought to the infirmary by their teachers. It was exhausting work, but Ms. P was glad to have had a role in protecting children from the potentially fatal virus.
One week later, however, Ms. P received a call from the school’s nurse, with whom she had become friendly during the time they worked together. The school nurse wanted to warn Ms. P that the mother of one of the kindergarten children who had been immunized was very angry that her daughter received the vaccine.
“Apparently, Mrs. L [the child’s mother] never returned the consent form,” explained the school nurse. “She thought that by not submitting a consent she was preventing her child from being vaccinated. This woman doesn’t believe in vaccinations, and is extremely upset that her child was inoculated without her consent. I don’t think we’ve heard the last about this.”
The school nurse was right. Within the month, Mrs. L sued the public-health department and Ms. P. The administration of the public-health department met with a malpractice attorney to discuss the situation.
“Mrs. L is alleging that the administration of the vaccination without consent constituted negligence and resulted in a battery on her daughter,” said the attorney. Before Ms. P could protest, the attorney continued. “Normally, she might have a case. However, we’re in the midst of a public-health crisis declared by the Secretary of Health and Human Services. I am going to file a motion to have this case dismissed on the grounds that the state has no jurisdiction since a federal public-health emergency was declared. The federal law should preempt the state law, and we should be able to make this case go away.”
Ms. P and her employers were relieved, but the relief was short-lived. The attorney soon notified the public-health department that the state court had decided that the federal PREP Act does not extend to situations in which a drug is administered without consent.
“I’m sorry,” said the attorney. “However, we can and will appeal.”
The attorney filed an appeal that hinged on just one issue: does the federal PREP Act preempt state law claims for negligence and battery? The appeals court held the federal emergency act does preempt state law, even when a vaccine is given without consent, and the case was dismissed.
In its decision, the appellate court considered the intent of Congress in enacting the federal law. The court cited language in the PREP Act that specifically provided liability protections for pandemic countermeasures taken by “covered persons” (in this case, clinicians).
The Act specifically provides that “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 an individual of a covered countermeasure” pursuant to a declaration of, among other things, a public-health emergency.
Although the child’s mother argued that administering a vaccination without consent voids any and all immunity under the law, the court did not agree. In fact, the court concluded that it was the intent of Congress to preempt all state law tort claims arising from the administration of immunizations—even when there was a failure to obtain consent.
The court specifically noted that Congress had created an alternative administrative remedy—called the Countermeasures Injury Compensation Program—to compensate people injured by countermeasures taken in response to the declaration of a public-health emergency. In addition, said the court, a person who suffered death or serious physical injury caused by willful misconduct of a clinician would still have a cause of action in federal court.
The court was not persuaded by Mrs. L’s arguments that Congress would not have intended to protect such a radical action as immunizing someone without consent. “It is not our role to speculate upon congressional judgments,” wrote the presiding judge in the court’s decision. “Rather, we must presume that Congress fully understood that errors in administering a vaccination program may have physical as well as emotional consequences, and determined that such potential tort liability must give way to the need to promptly and efficiently respond to a pandemic or other public-health emergency.”
The court concluded that the plaintiff’s state law claims for negligence and battery were preempted by the PREP act, and that the state court had no jurisdiction over the matter.
This was an unusual case, although it may be one that we see more often as new strains of influenza threaten our population. Ms. P was not liable because she had acted in accordance with a federal act, and that act trumped state law.
However, it is important to remember that under normal circumstances Ms. P could have faced a lawsuit, and potential liability, for vaccinating a child without the parent’s consent. If you work with children or in a school, remember that parental consent is always necessary, except in the most extreme of circumstances.