Opinion ID: 490920
Heading Depth: 1
Heading Rank: 2

Heading: facts

Text: 2 The government sought and was granted certification pursuant to 28 U.S.C. Sec. 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, 94 S.Ct. 2409, 40 L.Ed.2d 774 (1974). Our review is plenary. Berkovitz's amended complaint alleges the following facts. 3 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. 4 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 1 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. 2 5 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. 3 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. 6 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: 7 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. 8 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. 4 III. The Legal Background: Griffin and Varig 9 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. Secs. 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. Sec. 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. 10 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. Sec. 73.114(b)(1)(iii) (1974) (now codified at 21 C.F.R. Sec. 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. 11 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, 73 S.Ct. 956, 97 L.Ed. 1427 (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 [w]here there is room for policy judgment and decision, there is discretion. 346 U.S. at 36, 73 S.Ct. at 968 (quoted in 500 F.2d at 1064). 12 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. 13 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 discounting test results that were required to be considered significant. Id. at 1068. We concluded: 14 We do not hold that the Government may be liable for policy determinations made by its officials. Rather, we hold only that the Government may be liable where its employees, in carrying out their duties, fail to conform to pre-existing statutory and regulatory requirements. 15 Id. at 1069. 16 In this case, Berkovitz's complaint alleges a failure by the government to insure Lederle's compliance with applicable regulations, including, but not limited to: ... 42 C.F.R. 73.114(b)(1)(iii), App. at 29, the same regulation at issue in Griffin. Thus, if we are still bound by our holding in Griffin that release of a vaccine lot that does not satisfy regulatory criteria is not a discretionary function, Berkovitz's action under the FTCA may be maintained. See Internal Operating Procedures of the Court of Appeals for the Third Circuit, Chapter 8.C., discussed in Poulis v. State Farm Fire & Casualty Co., 747 F.2d 863, 867 (3d Cir.1984). On the other hand, if an intervening Supreme Court decision mandates a different result, we may not countenance the continued application in this circuit of a rule, even of our own devising, which is patently inconsistent with the Supreme Court's pronouncements. Cox v. Dravo Corp., 517 F.2d 620, 627 (3d Cir.), cert. denied, 423 U.S. 1020, 96 S.Ct. 457, 46 L.Ed.2d 392 (1975). See also McMahon v. McDowell, 794 F.2d 100, 108 (3d Cir.), cert. denied, --- U.S. ----, 107 S.Ct. 473, 93 L.Ed.2d 417 (1986). The government contends that because of the intervening decision in United States v. S.A. Empresa De Viacao Aerea Rio Grandense (Varig Airlines), 467 U.S. 797, 104 S.Ct. 2755, 81 L.Ed.2d 660 (1984), Griffin is no longer binding law. 17 In Varig and United States v. United Scottish Insurance Co., 467 U.S. 797, 104 S.Ct. 2755, 81 L.Ed.2d 660 (1984), decided in the same opinion, plaintiffs claimed that their injuries or damages from aircraft accidents had resulted from the negligence of the Federal Aviation Administration (FAA) and its predecessor, the Civil Aeronautics Agency (CAA), in approving aircraft designs. Congress granted the FAA authority to exercise its discretion in promulgating regulations governing inspection and licensing of aircraft. The FAA responded with a system under which manufacturers remain responsible for testing and compiling data, while the FAA receives the data for review and retains the option of performing spot-inspections with its own staff or surrogate representatives. 18 In Varig, the FAA had inspected the Boeing 707 before issuing a type certificate approving the aircraft design, but it apparently approved the aircraft at various stages without inspecting the design of the lavatory towel disposal receptacle which did not satisfy applicable safety regulations. The failure of that receptacle to contain a fire proved fatal to 124 persons on board the Boeing 707 aircraft involved in the accident. In Scottish, the FAA had approved, without performing its own inspection, an aircraft modification involving installation of a cabin heater which did not meet applicable safety regulations. That heater was the cause of a fire. 19 In considering the applicability of the discretionary function exception, the Court isolated two relevant factors useful in determining when the exception applies. First, it is the nature of the conduct, rather than the status of the actor, that governs whether the discretionary function exception applies in a given case. Id. at 813, 104 S.Ct. at 2764. The Court stated that the basic inquiry is whether the challenged acts of a Government employee--whatever his or her rank--are of the nature and quality that Congress intended to shield from tort liability. Id. The second factor was that the exception plainly was intended to encompass the discretionary acts of the Government acting in its role as a regulator of the conduct of private individuals. Id. at 813-14, 104 S.Ct. at 2764. The Court noted that Congress wished to prevent judicial 'second-guessing' of legislative and administrative decisions grounded in social, economic, and political policy through the medium of an action in tort. Id. at 814, 104 S.Ct. at 2765. 20 Applying this standard, the Court noted that what was at issue was the failure of the FAA to actually inspect the aspects of the design to which the fires were attributable. The Court construed plaintiffs' claims as challenging the FAA's decision to implement the 'spot-check' system of compliance review, and the application of that 'spot-check' system to the particular aircraft. Id. at 819, 104 S.Ct. at 2767. The Court concluded that the FAA's implementation of a mechanism for compliance review is plainly discretionary activity because, [w]hen an agency determines the extent to which it will supervise the safety procedures of private individuals, it is exercising discretionary regulatory authority of the most basic kind. Id. at 819-20, 104 S.Ct. at 2767. It followed that the acts of FAA employees in executing the 'spot-check' program in accordance with agency directives are protected because the FAA employees were empowered to decide how much confidence to place in a given manufacturer's procedures. Id. at 820, 104 S.Ct. at 2768. 21 Following Varig, this court has twice questioned the continued vitality of Griffin. In General Public Utilities Corp. v. United States, 745 F.2d 239 (3d Cir.1984), cert. denied, 469 U.S. 1228, 105 S.Ct. 1227, 84 L.Ed.2d 365 (1985) (GPUC ), the owners of the Three Mile Island nuclear facility filed an FTCA suit based on the failure of the Nuclear Regulatory Commission to investigate an occurrence at another nuclear plant and to communicate warnings based thereon. We held that the claims were barred because the Commission exercised discretion in making policy determinations to decide when occurrences were significant enough to warrant investigation and warning. Id. at 244-46. We rejected plaintiffs' attempted reliance on Griffin as excluding professional and scientific judgments from the discretionary category both because Griffin ... must be read cautiously because in Varig the discretionary exception covered an agency decision that rested on highly technical information and because the Commission exercised discretion in making non-technical judgments as to public health and safety. Id. at 246. 22 Thereafter, in Smith v. Johns-Manville Corp., 795 F.2d 301 (3d Cir.1986), we again noted that Griffin's distinction between scientific evaluation and policy judgments must be read cautiously in light of Varig. Id. at 309 & n. 13. In that case, defendants who were sued by present and former employees of Johns-Manville for injuries resulting from exposure to asbestos filed third-party claims against the United States under the FTCA based on the General Services Administration's failure to label asbestos sold to them as part of the government's asbestos disposal scheme. We rejected the third party plaintiffs' claim that the failure to warn, when isolated from the overall decision to dispose of the asbestos as is, involved no policy judgment. We construed Dalehite as precluding this type of compartmentalization of agency decisions, and concluded that, when considered as a whole, implementation of the disposal scheme required the GSA to exercise discretion to avoid market disturbances and maximize the government's revenues. Id. at 308. Because these were policy decisions, the discretionary function exception precluded the third party claims. Id. at 308-09. 23 Although the opinions in GPUC and Smith suggest that Griffin must be reevaluated in light of Varig, we had no occasion to decide whether Griffin is effectively overruled, a position the government now urges us to adopt.