On Appeal from the United States District Court for the Western District of Pennsylvania, D.C. Civil No. 84-2893.
HIGGINBOTHAM and SLOVITER, Circuit Judges, and ROTH, District Judge*fn*
In Griffin v. United States, 500 F.2d 1059 (3d Cir. 1974), this court held that a suit alleging negligence on the part of the Division of Biologic Standards (DBS) in approving for production and distribution a polio vaccine which subsequently caused the plaintiff's paralysis was not barred by the discretionary function exception to United States liability under the Federal Tort Claims Act (FTCA). In United States v. S.A. Empresa De Viacao Aerea Rio Grandense (Varig Airlines), 467 U.S. 797, 81 L. Ed. 2d 660, 104 S. Ct. 2755 (1984), the Supreme Court held that the discretionary function exception barred an FTCA suit based on the negligence of the Federal Aviation Administration (FAA) in certifying an aircraft that did not comply with applicable safety regulations. The FTCA action before us makes allegations of government negligence virtually indistinguishable from those asserted in Griffin. The question before us on this interlocutory appeal is whether our holding in Griffin remains binding following the Supreme Court's pronouncement in Varig on the scope of the discretionary function exception.
The government sought and was granted certification pursuant to 28 U.S.C. § 1292(b) of the district court's order denying its motion to dismiss this action for lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1). The district court was obliged to accept the factual averments of the complaint as true for purposes of the motion. See Curtis v. Everette, 489 F.2d 516, 518 (3d Cir. 1973), cert. denied, 416 U.S. 995, 40 L. Ed. 2d 774, 94 S. Ct. 2409 (1974). Our review is plenary. Berkovitz's amended complaint alleges the following facts.
Kevan Berkovitz, a minor, received a dose of Orimune, a Sabin Oral Poliomyelitis Vaccine manufactured by Lederle Laboratories (Lederle), on May 10, 1979 and contracted paralytic poliomyelitis within a month. The Communicable Disease Center, a United States agency, determined that Berkovitz had contracted polio from the vaccine.
Prior to 1972, the Division of Biologic Standards (DBS), a division of the National Institutes of Health, licensed Lederle to produce a trivalent oral vaccine using live virus of the Sabin strains. Lederle then developed from the original Sabin strains a seed virus which DBS licensed it to produce despite the fact that it did not satisfy standards for neurovirulence set forth in the regulations applicable to live polio vaccines. After 1972, a division of the Food and Drug Administration (FDA) took over responsibility for approval and licensure of live polio vaccines. The FDA approved a monopool of virus*fn1 developed from the defective seed virus for use in production despite the fact that the monopool was tested and found to exceed the applicable standards for neurovirulence. This defective monopool was subsequently used by Lederle in the manufacture of the lot of trivalent oral polio vaccine, Orimune, administered to Berkovitz.*fn2
Berkovitz (joined by his parents as his guardians) filed a complaint in federal district court, after following the requisite administrative procedure. The complaint asserts a claim against the United States under the Federal Tort Claims Act for the negligence of DBS in licensing and of the FDA in approving for release the live polio vaccines.*fn3 Specifically, Berkovitz alleges that he suffered damages as a result of: 1) the negligence of DBS in licensing Lederle for the original Sabin strains; 2) the negligence of the FDA in approving for production and release the lot of trivalent vaccine manufactured from the defective monopool; 3) the negligence of the FDA in failing to withdraw the defective vaccine from the market; and 4) the negligence of the FDA in failing to require Lederle to warn of the risks of the defective vaccine.
The government moved for dismissal for lack of subject matter jurisdiction on the grounds that the agency actions challenged fall within the discretionary function exception to the United States' waiver of sovereign immunity under the FTCA. In ruling on the government's motion, the district court relied on this court's prior decision in Griffin:
In Griffin, the plaintiff sustained personal injuries resulting from the ingestion of a [vaccine] which did not conform to the defendant's regulations. The Third Circuit concluded that the government was not immune from suit pursuant to the discretionary function exception . . . since the government employee's conduct in implementing agency regulations required only scientific evaluation and not the formulation of policy.
App. at 51-52. The court rejected the government's argument that the Griffin holding does not survive the Supreme Court's subsequent decision in Varig. The district court stated that under Third Circuit Internal Operating Procedure 8.C., "no matter how persuasive the arguments may be that Griffin is no longer valid, we are bound to apply the principles in Griffin." App. at 55. Applying those principles, the court concluded that the discretionary function exception barred Berkovitz's claims of "alleged failure to warn and withdraw the product" but did not bar Berkovitz's claims of "negligent licensure and approval" of either the original Sabin strains or the lot of vaccine administered to Berkovitz. App. at 56.*fn4
The Legal Background: Griffin and Varig
Under the FTCA, the United States waives its sovereign immunity from suit for compensatory damages for personal injury resulting from the conduct of a government employee acting within the scope of his employment. 28 U.S.C. §§ 1346(b), 2674. One of the exceptions to which that waiver is subject provides that the United States does not waive its sovereign immunity from actions "based upon the exercise or performance of or the failure to exercise or perform a discretionary function or duty." 28 U.S.C. § 2680(a). We have treated the discretionary function exception as establishing a jurisdictional bar. See Smith v. Johns-Manville Corp., 795 F.2d 301, 306 n.8 (3d Cir. 1986); Gibson v. United States, 457 F.2d 1391, 1392 n.1 (3d Cir. 1972). The government contends that Berkovitz's action falls within the discretionary function exception and is barred by the United States' sovereign immunity.
Reading Berkovitz's complaint in the way most favorable to Berkovitz, it is clear that, at least in part, Berkovitz alleges a violation of regulations identical to those at issue in Griffin v. United States, 500 F.2d 1059 (3d Cir. 1974). Griffin, who had contracted polio after ingesting a Sabin type polio vaccine, sued the United States alleging DBS negligence in releasing the vaccine at issue. At that time, as now, agency regulations allowed release of vaccine only if, after a "comparative evaluation" of five criteria with a reference strain of vaccine, "a comparative analysis of the test results demonstrate that the neurovirulence of the test virus pool does not exceed that of the NIH Reference . . . " Id. at 1062-63 n.7 (quoting 42 C.F.R. § 73.114(b)(1)(iii) (1974) (now codified at 21 C.F.R. § 630.16(b)(1)(iii) (1987))). Tests performed by DBS indicated that the vaccine at issue displayed greater neurovirulence than the reference on all five enumerated criteria. Id. at 1067 & n. 18. Griffin contended that DBS could be held liable for its release of the vaccine in violation of its own regulations. The government contended both that the decision to release the lot of vaccine in question involved the exercise of a discretionary function and that "Congress intended, by the discretionary function exception . . ., to exclude all claims 'arising from acts of a regulatory nature.'" Id. at 1063.
We noted that "accepting the Government's [latter] contention would effectively immunize all Governmental activity from judicial review except the most ministerial acts." Id. at 1063-64. Instead we construed the decision in Dalehite v. United States, 346 U.S. 15, 97 L. Ed. 1427, 73 S. Ct. 956 (1953), as limiting the discretionary function exception to activity involving "considerations of public policy", 500 F.2d at 1064, focusing on the Court's statement in Dalehite that "where there is room for policy judgment and decision, there is discretion." 346 U.S. at 36 (quoting in 500 F.2d at 1064).
Although we accepted DBS' construction of its regulations as allowing "judgmental determination as to the degree to which each of the enumerated criteria indicated neurovirulence in monkeys," we concluded that this was "a scientific, but not policy-making, determination." 500 F.2d at 1066. We pointed out that "responsibility was limited to merely executing the policy judgments of the Surgeon General." Id.
For this reason, we concluded that DBS' discretion in "performance of scientific evaluation" did not justify immunization from judicial review. Id. Moreover, we noted that DBS had no discretion "to disregard the mandatory regulatory command" under the "biological variation" rubric that it had applied and that DBS had exceeded its authority under the regulations by ...