Kevan Berkovitz (plaintiff), a 2-month-old infant orally ingested an oral polio vaccine. A month later, he contracted a severe case of polio which left him paralyzed on one side of his body and unable to breathe on his own. The vaccine itself and the particular lot which contained Berkovitz’s dose had previously been licensed and released by the United States government (defendant) through its Division of Biologic Standards (DBS) and the Bureau of Biologics of the Food and Drug Administration (FDA). Berkovitz and his parents as guardians brought suit against the United States under the Federal Tort Claims Act (FTCA) in federal district court. The district court held that the licensing and releasing of the polio vaccine is not a “discretionary function” under the FTCA, and thus the United States is not immune from suit based on its performance of these functions. The district court held for Berkovitz, and the United States appealed. The court of appeals reversed, and the United States Supreme Court considered the case.