## Facts

- In 2009, during the H1N1 influenza outbreak, the U.S. Secretary of Health and Human Services issued emergency declarations under the Public Readiness and Emergency Preparedness Act (PREP Act) covering certain countermeasures, including the H1N1 vaccine.
- New York’s Governor declared a disaster emergency and authorized state and local health departments to establish immunization programs to facilitate H1N1 vaccine distribution.
- On December 3, 2009, the St. Lawrence County Public Health Department held an H1N1 vaccination clinic at Lisbon Central School.
- Jennifer Parker did not sign a parental consent form authorizing vaccination of her kindergarten-aged daughter, Madison.
- A nurse employed by the Department administered an H1N1 vaccination to the child despite the lack of signed parental consent.
- Parker sued the Department asserting state-law claims for negligence and battery based on the nonconsensual vaccination and alleged resulting harm.

## Issues

1. Whether the PREP Act preempts state-law negligence and battery claims arising from administration of an H1N1 vaccine during a declared public health emergency when the vaccine was administered without parental consent.
2. Whether PREP Act immunity deprives a New York state court of subject matter jurisdiction over those state-law claims against a local public health department.

## Decision

- The Appellate Division, Third Department reversed the order denying the Department’s motion to dismiss.
- The court held that the PREP Act’s immunity and express preemption provisions applied to the Department as a covered person and to the H1N1 vaccine as a covered countermeasure administered during the emergency program.
- The court concluded that the negligence and battery claims were preempted because they were claims for loss “caused by, arising out of, relating to, or resulting from” administration of a covered countermeasure.
- The court rejected a consent-based limitation on PREP Act immunity, holding that lack of consent did not remove the claims from the statute’s broad “relating to” coverage.
- The complaint against the Department was dismissed for lack of subject matter jurisdiction based on federal preemption and immunity.

## Legal Principles

- The PREP Act provides covered persons immunity from suit and liability under federal and state law for claims for loss “caused by, arising out of, relating to, or resulting from” administration or use of a covered countermeasure during a declared public health emergency, subject to a limited willful-misconduct exception.
- The Act expressly preempts state-law causes of action within the scope of that immunity and channels most injury claims to a federal administrative compensation program.
- State-law theories, including intentional tort claims such as battery, are preempted when they seek recovery for loss connected to administration of a covered countermeasure by a covered person during the declared response.
- An asserted lack of patient or parental consent, without more, does not create an implied exception to PREP Act immunity where the claim still “relates to” administration of the covered countermeasure.
- When PREP Act preemption and immunity apply, state courts lack subject matter jurisdiction over the displaced state-law claims.

## Conclusion

The court held that the PREP Act broadly preempted state negligence and battery claims arising from an H1N1 vaccination administered at an emergency clinic, even when given without parental consent, requiring dismissal for lack of subject matter jurisdiction and leaving plaintiffs to the statute’s exclusive federal remedial scheme (absent a properly pleaded willful-misconduct claim).


Parker v. St. Lawrence Cnty. Pub. Health Dep’t, 102 A.D.3d 140, 954 N.Y.S.2d 259 (N.Y. App. Div. 3d Dep’t 2012)