Legal Document

486 U.S. 531 108 S.Ct. 1954 100 L.Ed.2d Kevan BERKOVITZ, a Minor by his Parents and Natural Guardians Arthur et ux., al., Petitioners,v.UNITED STATES. No. 87-498. Argued April 19, 1988. Decided June 13, Syllabus A provision of the Federal Tort Claims Act (FTCA) excepts from statutory liability any claim "based upon [a federal agency's or employee's] exercise performance failure to perform discretionary function duty." Upon contracting severe case polio after ingesting dose Orimune, an oral vaccine manufactured Lederle Laboratories, petitioner Berkovitz, minor, joined parents (also petitioners) acting asguardians, filed FTCA suit alleging violations law policy National Institutes Health's Division Biologic Standards (DBS) in licensing produce Bureau Biologics Food Drug Administration (FDA) approving release public particular lot containing Berkovitz's dose. The District Court denied Government's motion dismiss for lack subject-matter jurisdiction, but Appeals reversed. Although rejecting argument that exception bars all claims arising out agencies' regulatory activities, court held vaccines are wholly actions protected exception. Held: 1. language, purpose, legislative history exception, as well its interpretation this Court's decisions, establish does not preclude acts programs, insulates only those governmental decisions involve element judgment choice based on considerations. Pp. 535-539. 2. erred holding petitioners' claims. 539-548. (a) Statutory provisions require DBS, prior issuing license product such receive data which manufacturer is required submit, examine product, make determination it complies with safety standards. Thus, cause action petitioner's allegation DBS licensed Orimune without first receiving barred since has no discretion issue under circumstances, doing so would violate specific directive. Petitioners' other claim—that even though did comply certain standards—if interpreted mean issued determining compliance standards comply, also charges agency failing act accordance mandatory directives, discretion. However, if made incorrect determination, question exception's applicability turns whether officials making permissibly choice, point clear record therefore must be decided petitioners choose press interpretation. 540-545. (b) scheme governing lots allows FDA determine appropriate manner regulate, have alleged that, authority granted regulations, adopted testing preventing distribution fails notwithstanding policy, knowingly approved unsafe question. Accepting these allegations true, necessary reviewing dismissal, was improper, complained do permissible noncomplying basis 545-548. 822 F.2d 1322 (CA3 1987), reversed remanded. MARSHALL, J., delivered opinion unanimous Court. Ellen M. Viakley, petitioners. Michael K. Kellogg, Washington, D.C., respondent. Justice MARSHALL 1 (FTCA Act), 28 U.S.C. § 2680(a), subsequent approval public. 2 * On May 10, 1979, then 2-month-old infant, ingested Laboratories. Within one month, he contracted polio. disease left Berkovitz almost completely paralyzed unable breathe assistance respirator. Communicable Disease Center, Government, determined had vaccine. 3 guardians, subsequently against United States Court.1 complaint liable injuries FTCA, §§ 1346(b), 2674, because (DBS), part Health, acted wrongfully Laboratories According petitioners, violated regarding inspection vaccines. 4 Government moved jurisdiction ground fell within FTCA. motion, concluding neither nor "discretionary function" meaning Civ.Action 84-2893 (WD Pa., Apr. 30, 1986). At request, certified decision immediate appeal Third Circuit pursuant 1292(b), accepted jurisdiction. 5 divided panel (1987). initially rejected activities agencies. stated "the inapplicable non-discretionary actions," id., at 1328, noted employees agencies command statutes regulations. Contrary claim, however, imposed duties respect virus Likening applicable found confer v. Varig Airlines, 467 797, 104 2755, 81 660 (1984), concluded were and, such, could form States. dissenting judge argued relevant regulations obligated submission test relating deny when showed failed conform Reading bar suit. 6 We certiorari, 484 1003, 692, 98 645 (1988), resolve conflict Circuits effect regulation Compare 1322, supra, Baker States, 817 560, 564-566 (CA9 1987) (holding negligent vaccine); Loge 662 1268, 1272-1273 (CA8 1981) negligence both lot). now reverse Circuit's judgment. II 7 generally authorizes suits damages 8 "for injury loss property, personal death caused wrongful omission employee while scope office employment, circumstances where private person, claimant place occurred."2 9 includes number exceptions broad waiver sovereign immunity. provides shall lie 10 "[a]ny . duty involved abused." 2680(a). 11 This we our most recent subject, "marks boundary between Congress' willingness impose tort desire protect exposure individuals." U.S., 808, S.Ct., 2761-2762. 12 guided several established principles. "it nature conduct, rather than status actor, governs applies given case." Id., 813, 2764. In examining challenged consider matter employee. inquiry mandated language exception; conduct cannot unless involves choice. See Dalehite 346 15, 34, 73 956, 967, 97 L.Ed. 1427 (1953) (stating protects executive administrator according one's best course"). will apply statute, regulation, specifically prescribes course follow. event, rightful option adhere And employee's appropriately there protect. Cf. Westfall Erwin, 292, 296-297, 580, ----, 619 (1988) (recognizing independent unaffected threat liability). 13 Moreover, assuming judgment, kind designed shield. "prevent judicial 'second-guessing' administrative grounded social, economic, political through medium tort." 814, 2764-2765. properly construed, considerations policy. 36, 968 ("Where room discretion"). sum, 14 Airlines illustrates propositions. two cases resolved victims airplane accidents who Aviation (FAA) negligently certifying airplanes operation. characterized challenging FAA's certify inspecting them immune liability. reaching result, carefully reviewed certification airplanes. Congress Secretary Transportation implement program enforcing authority, FAA, Secretary's designee, devised system "spot-checking" compliance. establishment represented how "accommodat[e] goal air transportation reality finite resources." 820, 2767-2768. FAA executing 'spot-check' program" "were empowered judgments degree confidence might reasonably placed manufacturer, need maximize efficient allocation Ibid. they range accorded results determinations.3 15 restating clarifying intend reject argument, pressed Appeals, precludes programs That rebutted "discretionary" functions, "regulatory" functions. significance supported history. As previously indicated, materials demonstrate cover their employees, nature.4 33-34, 966-967. coverage accords purpose enacting exception: prevent "[j]udicial intervention political, economic judgments" including regulatory—agencies. twice before variant position. Indian Towing Co. 350 61, 64-65, 76 122, 124, 48 (1955) (disapproving "uniquely functions"); Rayonier, Inc. 352 315, 318-319, 77 374, 376-377, 354 (1957) (same).5 Varig, ignored precise makes case, focusing instead issue. To extent already put rest, now. nature. III 16 raises First, assert statute accompanying Orimune. Second, argue contained each wrongdoing.6 Because review adjudicated dismiss, accept factual true ask whether, dismissal appropriate. 17 Under law, marketing brand live 58 Stat. 702, amended, 42 262(a). order become eligible license, sample product. CFR 73.3 (Supp.1964); 21 601.2 (1987).7 process begins selection original strain. grows seed strain; used monopools, portions combined consumer-level set forth criteria strain, see 73.110(b)(2) 630.10(b)(2) (1987), virus, 73.110(b)(3), (4) 630.10(b)(3), 73.114 630.16 variety tests measure stage manufacturing process. 73.110, 630.10, completion testing, submit application DBS. (1987).8 addition application, performed finished 18 deciding provisions. Public Health Service provides: 19 "Licenses maintenance establishments propagation manufacture preparation products [including vaccines] may showing desired meet standards, insure continued safety, purity, potency products, prescribed licenses new All issued, suspended, revoked ." 351(d), 702-703, 262(d). 20 similarly "[a] examination 73.5(a) 601.4 addition, states "[a]n considered filed" until receives information submit. These regard various stages process, matched up App. 12-13; Brief Petitioners 5-6. allegation. described above require, precondition licensing, product's 262(d) (providing "only showing" manufacturer); (1987) deemed receipt data). data; Accordingly, having received data, imposes bar. 22 difficult describe precision. contend 12; 4-6.9 charge understood three ways. complied nonetheless vaccine's manufacture. Third, concede compliance, allege incorrect. Neither briefs entirely theory case. 23 If aver either claim. DBS's vaccines, except deviate procedure.10 absence challenge function. Rather, law. When accord directive, apply. 24 incorrect, requires somewhat different analysis. method exception.11 objective scientific 16-17, whereas asserts incorporates considerable "policy judgment," 36. assertions, parties framed appropriately; hinges parties, addressed detail, us indication way interprets setting Given particularly abstruse, hesitate decide scanty us. leave decide, B 25 distinct issuance licenses. former places obligation manufacturers ensure 610.1 (1978).12 corresponding Biologics. empower lot, 610.2(a) (1978), take cases. allow regulate lots, mandating kinds action. substantially similar discussed (1984). 26 context, Bureau's formulation lots. 819-820, 2767-2768 spot-checking program). policies formulated implementing judgments, taken charged respecting proper airplanes). leaves official performing act, simply wrongful. 69, 126-127 maintain lighthouse good working subjected initial undertake service judgment). 27 Viewed light principles, survives dismiss. fail comply. further allegedly 13; 20-21; Reply 15-17. directed Petitioners, course, proved allegations, correct—that is, took considerations—the claim.13 yet show, obtained discovery otherwise, here discretion, invocation improper. IV For foregoing reasons, lot. accordingly reversed, remanded proceedings consistent opinion. 29 It ordered. sued separate civil settled instant filed. There currently dispute falls general raised suit, state declined request appeal. (1955), illuminates plaintiff order. 126-127. held, condition ibid. latter House Representatives Report final version stating "a agency, Trade Commission Securities Exchange Commission, abuse officer employee, been involved. bill intended authorize validity provide remedy account involving Nor desirable constitutionality legislation, legality rule should tested damage tort. common-law torts included same nonregulatory agencies." H.R.Rep. 1287, 79th Cong., 1st Sess., (1945). passage regulators, acts. position times appears replicate precisely expressly Rayonier. (arguing preserve immunity "core function[s]"); 16. disputed arguments chose revoke Laboratories' raise petition writ certiorari. 1963. citation text time. Where remained form, parallel current Manufacturers obtain license. 73.2-73.4 601.1-601.2, 601.10 1972, transferred renamed 37 Fed.Reg. 12865 (1972). 1984, Office Research Review. 49 23834 amended accordingly. satisfy. strain requirement "free harmful administration recommended dosage least 100,000 people susceptible poliomyelitis." 73.110(b)(2)(i) 630.10(b)(2)(i) monopool, ultimate scheme's neurovirulence requirement. 73.110(b)(2)(ii), 73.110(b)(4), 73.114(b)(1) 630.110(b)(2)(ii), 630.110(b)(4), 630.16(b)(1) Neurovirulence capacity infectious agent pathologic effects central nervous system. refers ability paralytic poliomyelitis. injecting into monkeys. meets criterion specified animals survive "comparative analysis" demonstrates "does exceed" reference selected agency. 73.114(b)(1)(iii) 630.16(b)(1)(iii) Even conceded transcript reads: "QUESTION: [Supposing DBS] all, some papers I "Would regulation? "[COUNSEL]: No, regulation. ., wouldn't it? extreme instance you talking about definitely regulation." Tr. Oral Arg. 34-35. noted, n. 9, satisfied strains free effect. presented thus protects. time released None changed significantly dealing subject title section numbers cited text. own support indicated reviews decides 42. suggested knew approve 31-32.

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