Berkovitz v. United States

In Berkovitz v. United States, 486 U.S. 531 (1988), a two-month-old child contracted a severe case of polio, after ingesting an oral vaccine that had been approved by Federal agencies. The child and his parents brought suit, under the Federal Tort Claims Act (FTCA), alleging that the National Institutes of Health's Division of Biologic Standards had wrongfully licensed the vaccine manufacturer to produce the vaccine at issue and that the Bureau of Biologics of the Food and Drug Administration had acted wrongfully in approving for release to the public the particular lot of vaccine from which the defective dose had been obtained. Both agencies, the plaintiffs claimed, "violated federal law . . . regarding the inspection and approval of polio vaccines." 486 U.S. at 533. In rejecting the Government's claim that the suit should be dismissed because the actions taken by the two agencies fell within the discretionary function exception, the Supreme Court first noted: "The discretionary function exception applies only to conduct that involves the permissible exercise of policy judgment." Id. at 539. As a result, "when a suit," as in that case, "charges an agency with failing to act in accord with a specific mandatory directive, the discretionary function exception does not apply." Id. at 544. As for the claim alleging wrongdoing in releasing the vaccine lots, the Supreme Court examined the regulatory scheme and determined that it may have left "no room for implementing officials to exercise independent policy judgment." Id. at 547. If that characterization of the regulatory scheme were true, the claim would not be barred by the discretionary function exception, the Court pointed out, because it was "directed at a governmental action that allegedly involved no policy discretion." Id. Although the plaintiffs had not proved their factual allegations concerning the regulatory scheme, they were not, the Court observed, required to do so at that stage of the litigation. As further discovery might assist them in doing so, dismissal of their claim, said the Court, was inappropriate. Id. at 547-48.