Andrea Horowitz v. HHS - Hepatitis B, transverse myelitis and/or multiple sclerosis (2024)

Andrea Horowitz filed a claim under the National Vaccine Injury Compensation Program alleging that a hepatitis B vaccine she received in Australia on February 4, 2020, caused her to develop transverse myelitis and/or multiple sclerosis. The respondent, the Secretary of Health and Human Services, moved to dismiss the claim, arguing it was not cognizable under the Vaccine Act.

The respondent contended that the Act requires vaccines administered outside the United States to be manufactured by a U.S.-based manufacturer, and Ms. Horowitz had not demonstrated this requirement was met.

The vaccine was administered in Australia and was a GlaxoSmithKline (GSK) product, manufactured by GSK Australia. Ms.

Horowitz argued that the term "located" should be interpreted broadly to include companies with a significant presence in the U.S., such as GSK. The court analyzed the statutory language, noting that claims involving vaccines administered abroad have specific limitations to ensure a U.S. nexus and to protect the domestic vaccine market and manufacturers.

The court found that Ms. Horowitz had not established that the specific vaccine she received was manufactured by a U.S.-based entity, nor had she demonstrated that GSK Australia could be considered "located" in the U.S. for the purposes of the Act.

Consequently, the court granted the respondent's motion to dismiss, finding the claim was not viable under the Vaccine Act. No compensation was awarded, and the petition was dismissed.