Mom Loses Suit Over Daughter’s H1N1 Vaccine

ALBANY, N.Y. (CN) - A mother who says public health officials in St. Lawrence County immunized her young daughter without her consent cannot sue, a New York appeals court ruled.

Upon declaration of a public health emergency, the federal Public Readiness and Emergency Preparedness Act pre-empts state tort claims, according to the six-page ruling from the Third Judicial Department of Appellate Division.

"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," Justice Karen Peters wrote for a five-judge panel.

The St. Lawrence County Public Health Department had arranged a clinic at Lisbon Central School in December 2009 amid a new flu outbreak never previously identified in animals or people.

The K-12 school is in the rural northern New York town of Lisbon, not far from Ogdensburg and the Canadian border.

Federal and state officials declared a public health emergency in response to the H1N1 influenza virus outbreak and recommended administration of the vaccine Peramivir.

A public health nurse inoculated kindergartner Madison Parker even though her mother, Jennifer Parker, had not signed a parental consent form.

Jennifer Parker then sued the school district and the health department in St. Lawrence County Supreme Court, alleging that immunization without consent amounted to negligence and battery on her daughter.

The school district subsequently was dismissed as a defendant because a cause of action was not stated. But the court declined to dismiss the claim against the health department, which had cited the Public Readiness and Emergency Preparedness Act, known as PREP, and argued that federal pre-emption created a lack of subject matter jurisdiction.

It appealed when the court found the PREP protections did not extend to a situation in which a governmental entity administered a drug without consent.

The Appellate Division concluded on Nov. 21 that PREP pre-empts state law claims. PREP contains an express pre-emption clause stating that, during a declared public health emergency, "no state ... may establish, enforce or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that (A) is different from, or is in conflict with, any requirement applicable under this section; and (B) related to the ... use, ... dispensing or administration by qualified persons of the covered countermeasure," Peters wrote.

A "qualified person" includes licensed health professionals, and liability protections in pandemics "are specifically provided for" in PREP, she added.

"Considering the breadth of the preemption clause together with the sweeping language of the statute's immunity provision, we conclude that Congress intended to preempt all state law tort claims arising from the administration of covered countermeasures by a qualified person pursuant to a declaration by the Secretary [of Health and Human Services]," the decision states.

The justices said they were "unpersuaded" by Parker's claim that immunity under PREP did not extend to anyone administering a drug without consent.

"The immunity provisions of the PREP Act are triggered where, as here, the vaccines are purchased pursuant to a federal contract or agreement," Peters wrote.

PREP also created the Countermeasures Injury Compensation Program, which handles claims by individuals who suffer adverse reactions to devices, medications or therapies that have been recommended for use in public health emergencies, the decision notes.

Peters further noted that separate federal causes of action exist for wrongful death or serious physical injury resulting from misconduct by licensed health professionals.

"The provision of these exclusive federal remedies further supports our finding of preemption," she wrote.

Since a federal cause of action is "the exclusive remedy" under PREP, "the complaint must be dismissed for lack of subject matter jurisdiction," the decision states.

The St. Lawrence County attorney, Michael Crowe, argued for the health department. Mathew Duprey, of Lekki, Hill, Duprey & Bhatt in Canton, represented Parker.

Anisha Dasgupta of the U.S. Attorney's Office for the Northern District and Allyson Levine of the New York Attorney General's Office filed amicus briefs supporting the health department.

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