Document: 129 S. Ct. 1187 (2009) WYETH, Petitioner, v. Diana LEVINE. No. 06-1249. Supreme Court of United States. Argued November 3, 2008. Decided March 4, 2009. *1190 Edwin Kneedler for the States as amicus curiae, by special leave Court, supporting petitioner. David C. Frederick, respondent. Bert W. Rein, Karyn K. Ablin, Brendan J. Morrissey, Wiley Rein LLP, Washington, DC, Allan R. Keyes, Joseph O'Rourke, Ryan, Smith, Carbine, Ltd., Rutland, VT, Seth P. Waxman, Counsel Record, Paul R.Q. Wolfson, Catherine M.A. Carroll, Margaret Williams, Smith Wilmer Cutler Pickering Hale and Dorr William Ruane, Wyeth, Madison, NJ, Richard I. Rubin, Kidney, Myer & DeWolfe, Barre, Vermont, Scott H. Angstreich, Attaway, Crimmins, Kellogg, Huber, Hansen, Todd, Evans Figel, P.L.L.C., D.C., For U.S. Briefs, see: 2008 WL 2273067 (Pet.Brief) 3285388 (Resp.Brief) 4264481 (Reply.Brief) Justice STEVENS delivered opinion Court. Directly injecting drug Phenergan into a patient's vein creates significant risk catastrophic consequences. A Vermont *1191 jury found that petitioner manufacturer drug, had failed to provide an adequate warning awarded damages respondent Levine compensate her amputation arm. The warnings on Phenergan's label been deemed sufficient federal Food Drug Administration (FDA) when it approved Wyeth's new application in 1955 later changes drug's labeling. question we must decide is whether FDA's approvals Wyeth with complete defense Levine's tort claims. We conclude they do not. I brand name promethazine hydrochloride, antihistamine used treat nausea. injectable form can be administered intramuscularly or intravenously, intravenously through either "IV-push" method, whereby injected directly vein, "IV-drip" introduced saline solution hanging intravenous bag slowly descends catheter inserted vein. corrosive causes irreversible gangrene if enters artery. injury resulted from IV-push injection Phenergan. On April 7, 2000, previous visits local clinic treatment migraine headache, she received intramuscular Demerol headache Because combination did not relief, returned day second both drugs. This time, physician assistant drugs entered artery, because needle penetrated artery escaped surrounding tissue (a phenomenon called "perivascular extravasation") where came contact arterial blood. As result, developed gangrene, doctors amputated first right hand then entire forearm. In addition pain suffering, incurred substantial medical expenses loss livelihood professional musician. After settling claims against health center clinician, brought action relying common-law negligence strict-liability theories. Although labeling warned danger following inadvertent intra-arterial injection,[1] alleged *1192 was defective instruct clinicians use IV-drip method administration instead higher method. More broadly, reasonably safe foreseeable risks limb are great relation therapeutic benefits. App. 14-15. filed motion summary judgment, arguing failure-to-warn were pre-empted law. court no merit field pre-emption argument, which has since abandoned, its conflict argument. With respect contention there "actual between specific FDA order," id., at 21, action, reviewed sparse correspondence about evidence "earnestly attempted" strengthen "specifically disallowed" stronger language, 23. record, developed, "lack[ed] any set ceiling this matter." Ibid. presented during 5-day trial showed perivascular extravasation almost entirely eliminated IV-drip, rather than IV-push, administration. An IV drip started saline, will flow properly fluid entering tissue. See 50-51, 60, 66-68, 75. By contrast, even careful experienced clinician using occasionally expose 73, 75-76. While advised "[w]hen administering irritant usually preferable inject tubing infusion known functioning satisfactorily," 390, contain record also contains discussing label. 1955. 1973 1976, submitted supplemental applications, agency after proposing changes. third 1981 response rule governing labels. Over next 17 years, intermittently corresponded most notable activity occurred 1987, suggested different exposure, 1988, revised incorporating proposed respond. Instead, 1996, requested and, without addressing 1988 submission, instructed "[r]etain verbiage current label" regarding injection. Id., 359. few further related injection, 1998, instructing final printed "must identical" package insert. 382. Based regulatory history, judge could *1193 consider compliance requirements but such establish adequate. He instructed, objection regulations "permit change product add prior approval so long submits review approval." 228. Answering questions verdict form, negligent, result inadequate instructions, intervening cause broken causal connection defects plaintiff's injury. 233-235. It total $7,400,000, reduced account earlier settlement clinician. 235-236. August 2004, comprehensive denying judgment matter making findings fact based (supplemented one letter trial), rejected arguments. determined direct state-law those permit strengthened interim basis contained least 20 reports amputations similar 1960's. state liability case would obstruct work paid more passing attention warn addition, noted law serves compensatory function distinct regulation. 249-252. affirmed. held jury's "did [Wyeth] have approval, create floor, ceiling, regulation." ___ Vt. ___, 944 A.2d 179, 184 (2006). dissent, Chief Reiber argued conflicted inconsistent conclusion effective. importance issue, coupled changed position now endorses views expressed Reiber's persuaded us grant petition certiorari. 552 128 1118, 169 L. Ed. 2d 845 (2008). judgments "preempt premised theory necessary make use." Pet. Cert. i. II makes two separate arguments: first, impossible comply duty modify violating law, see Fidelity Fed. Sav. Loan Assn. de la Cuesta, 458 141, 153, 102 3014, 73 664 (1982), second, recognition unacceptable "obstacle accomplishment execution full purposes objectives Congress," Hines Davidowitz, 312 52, 67, 61 *1194 S.Ct. 399, 85 581 (1941), substitutes lay decision expert FDA. preface our evaluation these arguments, identify factual propositions decided proceedings, emphasize legal principles guide analysis, history controlling statute. proceedings established included drug. greater dose prescribed, may inadvertently continued complained pain. Nevertheless, argument clinician's conduct absolved liability. 234 (jury verdict), 252-254. finding negligent well strictly liable, foreseeable. That but-for proximate supported longer challenged Wyeth.[2] critical defect lack offered should contraindicated never Perhaps reason, dissent incorrectly assumes issue contraindicate See, e.g., post, 1221, 1230-1231. But, explained, only insufficient. mandate particular replacement warning, nor require contraindicating administration: "There number ways completely eliminating administration." Vt., n. 2, A.2d, 189, 2. therefore need proscribing pre-empted. narrower pre-empts claim Our answer guided cornerstones jurisprudence. First, "the purpose Congress ultimate touchstone every case." Medtronic, Inc. Lohr, 518 470, 485, 116 2240, 135 700 (1996) (internal quotation marks omitted); Retail Clerks Schermerhorn, 375 96, 103, 84 219, 11 179 (1963). Second, "[i]n all cases, particularly `legislated... traditionally occupied,' ... `start assumption historic police *1195 powers superseded Federal Act unless clear manifest Congress.'" U.S., 2240 (quoting Rice Santa Fe Elevator Corp., 331 218, 230, 67 1146, 91 1447 (1947)).[3] order "purpose appropriate briefly regulation 1906, enacted public Drugs Act, ch. 3915, 34 Stat. 768. prohibited manufacture interstate shipment adulterated misbranded drugs, supplemented protection consumers already provided 1930's, became increasingly concerned unsafe fraudulent marketing, Food, Drug, Cosmetic (FDCA), 675, 52 1040, amended, 21 U.S.C. § 301 et seq. Act's innovation provision premarket required submit application, including investigations specimens labeling, review. Until effective, distributing reject labeled, though act, effective 60 days filing. FDCA, 505(c), 1052. 1962, amended FDCA shifted burden proof manufacturer. Before prove harm keep out market, amendments demonstrate "safe under conditions recommended, labeling" before distribute §§ 102(d), 104(b), 76 781, 784. effectiveness introducing "substantial effect purports represented labeling." 781. enlarged "protect health" "assure safety, effectiveness, reliability *1196 drugs," 780, took care preserve 1962 added saving clause, indicating invalidated upon "direct positive conflict" FDCA. 202, 793. Consistent provision, suits "continued unabated despite Riegel Inc., 999, 1017, 892 (2008) (GINSBURG, J., dissenting); ibid., (collecting cases). And express devices 521, 90 574 (codified 360k(a)), declined enact prescription 2007, lawsuit, again 121 823. granted statutory authority safety information becomes available initial approval. 901(a), 924-926. doing so, however, Senate bill preapprove 1082, 110th Cong., 1st Sess., 208, pp. 107-114 (2007) (as passed) (proposing 506D). adopted construction manufacturers remain responsible updating their 925-926. III argues duties underlying duties. 3014. includes exact text 355; CFR 314.105(b) Generally speaking, approves application. There is, permits certain receiving agency's Among other things, "changes being effected" (CBE) provides changing "add contraindication, precaution, adverse reaction" instruction dosage intended increase product," filing FDA; wait 314.70(c)(6)(iii)(A), (C). CBE implicated amendment "to reflect newly acquired information." Fed.Reg. 49609. Resting language (which simply reaffirmed interpretation tried), contends considered. maintains pointed concerning Thus, insists, discharge obligation misapprehends scheme establishing defense. consistent version *1197 regulation, urge, accordance explained notice rule, "`newly information'" limited data, encompasses "new analyses previously data." 49604. accounts accumulates over time same data take meaning light subsequent developments: "[I]f sponsor event FDA, conducts analysis showing type severity frequency meets requirement `newly information.'" 49607; 49606. what argue change. did, present incidents amputation. 74, 252.[4] incident 1967, notified worked occur, analyzed accumulating unilaterally violated unauthorized distribution misbranding. Its subjected rests rendered lacking But strengthening made 321(p)(1) (defining drug"); 310.3(h). Nor misbranded. does altered FDA-approved label; instead, misbranding focuses substance among proscribes labels fail include "adequate warnings." 352(f). Moreover, statute contemplates juries resolve claims, belief conclusive. 331, 332, 334(a)-(b). very idea bring enforcement pursuant difficult acceptneither identified done so. cramped reading broad FDCA's provisions fundamental misunderstanding. suggests manufacturer, bears primary responsibility Yet many regulations, remained central premise *1198 content times. charged crafting ensuring market. 201.80(e) (requiring revise soon reasonable association serious hazard 314.80(b) (placing post-marketing surveillance manufacturer); 49605 ("Manufacturers continue maintain update information"). Indeed, lacked When authority, manufacturer's obligations referred specifically reflects mechanism adding 925-926 (stating retains existing requirements, subpart B part 201 sections 314.70 601.12 title Code Regulations (or successor regulations)" (emphasis added)). apparent, adequately described risk, permitted Of course, just reviewing applications. absent label, requirements. evidence. attempted give kind FDA.[5] Tr. Oral Arg. 12-13; Brief Amicus Curiae 25. while suggest prohibit inappropriate fact. *1199 "no gave of" versus 249. likewise concluded affirmative 188-189. supplied dangers posed accordingly cannot credit prevented administration.[6] Impossibility demanding us, mere requiring maintains, interfere "Congress's entrust decisions strike balance competing objectives." Petitioner 46. find relies untenable congressional intent overbroad view power pre-empt establishes floor regulation: Once deem inadequate, regardless considered issue. glaring problem Congress' contrary. Building 1906 bolster consumer harmful products. Kordel States, 335 345, 349, 69 106, 93 (1948); Sullivan, 332 689, 696, 68 92 297 (1948). remedy harmed ineffective 1938 amendment. Evidently, widely rights relief injured consumers.[7] recognized *1200 remedies motivating produce warnings. If thought obstacle objectives, surely some point 70-year history. 1976 enactment devices, Riegel, S.Ct., 1009 ("Congress applied clause wrote applies devices").[8] silence awareness prevalence litigation, powerful intend oversight exclusive means effectiveness. O'Connor unanimous Court: "The weak indicated operation interest, nonetheless stand concepts tolerate whatever tension [is] them." Bonito Boats, Thunder Craft 489 166-167, 109 971, 103 118 (1989) supra, 1194 (discussing presumption pre-emption). Despite regard litigation achieving purposes, that, requires determine forth presumed performed precise balancing benefits standard leaves room judgments. advancing statement Congress, preamble 2006 format 8, 11, 42, 45, 50 (citing 71 3922 (2006)). preamble, declared "both `floor' `ceiling,'" "FDA preempts conflicting contrary State law." 3934-3935. stated actions, involving "threaten statutorily prescribed role evaluating regulating drugs." 3935. force Geier American Honda Motor Co., 529 861, 120 1913, 146 914 (2000); Hillsborough County Automated Medical Laboratories, 471 707, 713, 105 2371, 714 (1985). *1201 own determination, proclamations pre-emption. faced case, assertion objectives. authorized directly, cf. 360k (authorizing scope Devices Amendments' clause),[9] weight accord opinion. given "some weight" impact subject technica[l] relevant background complex extensive." Geier, 883, 1913. Even deferred Rather, attended explanation how affects scheme. agencies pronounce delegation unique understanding statutes administer attendant ability informed determinations pose Congress." Hines, U.S, 399; 1913; 495-496, 2240. law's depends thoroughness, consistency, persuasiveness. Cf. Mead 533 234-235, 2164, 150 292 (2001); Skidmore Swift 323 134, 140, 65 161, 89 124 (1944). Under standard, deference. issued rulemaking December "not policies federalism implications preempt 81103; 3969 (noting "proposed propose law"). 2006, finalized offering interested parties opportunity comment, articulated sweeping pre-emptive preamble. inherently suspect procedural failure. Further, odds reverses longstanding providing reasoned explanation, discussion interfered decades coexistence. plainly times litigation. Not once *1202 stood mission. To contrary, cast standards build repeatedly disclaimed attempt instance, believe evolution [would] development regulations." 63 66384. "minimal standards" labels, preclude states imposing additional requirements." Ibid.[10] keeping suits, appears regarded complementary resources monitor 11,000 market,[11] superior access especially postmarketing phase emerge. uncover unknown hazards incentives disclose promptly. They serve motivate persons come forward information. Failure-to-warn particular, lend manufacturers, bear maintained offers additional, important, layer complements regulation.[12]*1203 represents dramatic position. Largely position, presents analogous Geier. There, Honda's failure install airbags cars. Department Transportation (DOT) promulgated car range choices passive restraint devices. 875, Rejecting "`all airbag'" gradual phase-in mix restraints spur technological win acceptance. 879, airbags, variety sought." 881, contend nearly identical, but, described, quite different. DOT conducted formal plan Examining itself DOT's contemporaneous revealed factors weighed struck, conducting support independent obstructed regime. occasion bearing newfound opinion, "frustrate[s] implementation mandate," 3934, deference reasons explained.[13] "complex extensive" undercut recent pronouncements pre-emption, reveal coexistence traditional remediesa place each label.[14] *1204 short, like recently entitled weight. recognize might frustrate achievement case. V Accordingly, ordered. BREYER, concurring. write separately Court's "we Ante, 1203. sometimes help "uncover [encourage] risks." 1202. possible desire containing cautions instructions. note raise prices who sick unable obtain need. Lasagna, Chilling Effect Product Liability New Development, Maze 334, 335-336 (P. Huber Litan eds. 1991). seek acts hindrance drug-related sought. 506, (BREYER, concurring judgment); Bates Dow Agrosciences LLC, 544 431, 454-455, 125 1788, 161 687 (2005) concurring). embody lawful describing, example, floor. effect. 505, (opinion J.) (1985)). agree THOMAS, judgment. involved "add[ed] strengthen[ed]" "a reaction," *1205 314.70(c)(6)(iii)(A) (2008), "about 314.70(c)(6)(iii)(C), "reflect information," data," Phenergan, 49603, 49609 thus market beyond unconditional federally initially court's therefore, separately, join majority's implicit endorsement far-reaching implied doctrines. become skeptical "purposes objectives" approach, routinely invalidates laws perceived conflicts policy legislative generalized notions embodied within doctrines wander far Constitution, concur ensure liberties," Atascadero Hospital Scanlon, 473 234, 242, 3142, 87 171 (1985) omitted), "Constitution system dual sovereignty Government." Gregory Ashcroft, 501 452, 457, 111 2395, 115 410 (1991). Framers "`constitutionally mandated power,'" Hospital, "reduce tyranny abuse front," "federalist structure joint sovereigns preserves people numerous advantages," decentralized government sensitive diverse needs heterogeneous society" "increase[d] citizen involvement democratic processes," Gregory, 458, 2395. Furthermore, observed, "compound republic America" double security people" surrendered divided governments, portion allotted subdivided departments." Federalist 51, p. 266 (M. Beloff ed., ed.1987). federalist system, possess concurrent Government, limitations imposed Supremacy Clause." Tafflin Levitt, 493 455, 110 792, 107 887 (1990). way, Clause gives Government advantage [a] delicate balance" sovereigns. 460, "As acting impose States." "extraordinary system." Nonetheless, retain sovereign authority. Const., Amdt. 10 ("The delegated *1206 reserved respectively, people"); Alden Maine, 527 706, 119 144 636 (1999); Printz 521 898, 918-922, 117 2365, 138 (1997); York 505 144, 155-156, 112 2408, (1992); 457-459, 2395; Tafflin, 792. "[t]he constitution government, defined" "[t]hose indefinite." 237-238. protecting constitutional preservation maintenance much design Constitution Union National government." Texas White, 7 Wall. 700, 725, 19 227 (1869), quoted 162, 2408. protect operate terms. provides: "This Laws shall Pursuance thereof; Treaties made, Authority supreme Law Land; Judges bound thereby, Thing Contrary notwithstanding." Art. VI, cl. laws, then, "supreme" status "made Pursuance" "[t]his Constitution." Ibid.; 3 Story, Commentaries 1831, 694 (1833) (hereinafter Story) ("It supremacy attached only, pursuance constitution"). key structural amass too expense limitation, raised Constitution's conferral governmental powers, discrete, enumerated ones." Printz, 919, 2365; Morrison, 598, 618, 1740, 658 155-157, 2408; McCulloch Maryland, 4 Wheat. 316, 405, 579 (1819) ("This acknowledged powers").[1] limitation procedures *1207 President follow "Laws INS Chadha, 462 945-946, 2764, 77 317 (1983) (setting Bicameral Presentment Clauses, I, cls. 2-3, "prescribe define respective functions Executive process"). "[T]he acutely conscious bicameral Clauses essential functions," 951, allowing passage legislation proceeded step-by-step, deliberate deliberative process," 959, "finely wrought exhaustively considered" Framers, 2764. in, necessarily from, produced constitutionally presentment procedures. Story (Actions "which invasions residuary authorities smaller societies," land. merely usurpation, deserve treated such"). principles, "increasing[ly] reluctan[t] expand terms pre-emption." 459, (THOMAS, dissenting part). My precedents, jurisprudence, increased my concerns always applied. vague "potentially boundless" doctrine 907, (2000) (STEVENS, dissenting), Pharmaceutical Research Mfrs. America Walsh, 538 644, 678, 123 1855, 155 889 (2003) judgment) (referring "concomitant invoking arbitrary selection exclusion others"); Crosby Foreign Trade Council, 530 363, 388-391, 2288, 147 352 (SCALIA, (criticizing reliance discern "perfectly obvious face th[e] statute"); 874-883, 1913 (relying comments, Government's litigating law). Congressional musings, satisfy Clause. analyzing validly thereunder, "[e]vidence [must be] sought [provision] issue" Constitution. CSX Transp., Easterwood, 507 658, 664, 113 *1208 1732, 387 (1993); FERC, 535 1, 18, 122 1012, 152 47 (2002) ("[A] authority... [for] literally let alone State, until confers it" omitted; alteration original)); Camps Newfound/Owatonna, Town Harrison, 520 564, 617, 1590, 137 852 (1997) dissenting) "treating unenacted dubious"). Pre-emption freewheeling judicial inquiry ordinary meanings conflict." Bates, 1788 part) citation 911, ("[P]re-emption be, [or regulatory] exercise free-form policymaking" omitted)). turn text. Foster Love, 522 71, 464, 139 369 (finding "turn[ed] statutes" Court); 19, 1012. categories "where physical impossibility engaged commerce." Florida Lime Avocado Growers, Paul, 373 132, 142-143, 83 1210, 248 when, "under circumstances [state] stands (1941).[2] "it 1193 STEVENS, J.). majority explains, corresponding us. formulations deciding *1209 conflict, lead "impossibility" doctrine. 873, ("a penalizes requires"); Telephone Telegraph Co. Central Office Telephone, 524 214, 227, 1956, 141 222 (1998) (AT T) (when "directly law), cited 874, (describing AT T "cas[e] impossibility"); 1210 ("where impossibility"). generally narrow "impossibility standard," Crosby, 372-373, 2288 1210); Sprietsma Mercury Marine, 537 64-65, 518, 154 466 (2002); Locke, 89, 109, 1135, (2000)in overly sweep infra, 1211-1217, unnecessary rely fact, why "physical impossibility" best proxy determining instances "physically impossible" commands. Nelson, Preemption, 86 Va. L.Rev. 225, 260-261 (2000). individual engage behavior prohibits, contradictory commands notwithstanding electing refrain covered behavior. Therefore, conflict. ibid. (concluding limit cases Founding supports "logical-contradiction"); T, 1956 law); 1836, 701 (suggesting "repugnant States" contours am satisfied respondent's below. state-court pre-empted, general "direc[t] 1956. 314.70(c)(6)(iii), physically ante, 1196-1197. allows preapproval *1210 learning incidences gangrene-induced resulting 1196-1197, "strengthen warning," a... precaution," [of method] 314.70(c)(6)(iii)(C). continuing prohibits marketing except approved. 355(a) ("No person introduce deliver introduction commerce subsection (b) (j) section drug" say, does, (i.e., label) say unfettered right, Initial amounts gaining represent manufacturerafter labelto drug." 201.80(e). "establish records reports" "[a]ny associated humans, related," 314.80(a), (c), (j). periodic "adverse experience[s]" actions taken last report experiences (for studies initiated)." 314.80(c)(2)(i)-(ii). withdraw 314.80(j); 355(e) Secretary finds applicant maintaining records, deliberately reports"). "clinical experience, tests, scientific *1211 (approval withdrawn clinical show approved"). accompanying process, guarantee changed. nothing insulates sum, away, Vermont-law here. neither insulated 221-226, forbade common carriers extending communications privileges claims); Foster, 68-69, 464 elections date statute). "recognition [this] `obstacle Congress,' FDA." 1193-1194. body jurisprudence flawed. improperly atextual purpose, inaction 1192-1194. claim, 1199-1204, reaffirmation 1199-1200 (analyzing purposes); 1201 "`purposes objectives'" 1913); 1202-1203, nn. 13-14 914). 1 formulated Alien Registration Commonwealth Pennsylvania. statutes, terms, conflicted. 59-60, 399 Pa. Ann., Tit. 35, 1801-1806 (Purdon Supp.1940)); 5, June 28, 1940, 54 670); 69-74, extratextual sources concluding conflict); 78, "[i]t conceded *1212 act statute" (Stone, dissenting)).[3] confined considering analysis. went ask "stands 399. doing, looked embarked freeranging speculation been. text, nature exerted object attained, character 70, sentiment, noting "[o]pposition laws... singling aliens dangerous undesirable groups, deep-seated country." relied statements Members inaction, pertinent bills Pennsylvania's garner enough votes 71-73, 32-34, Concluding personal liberties law-abiding uniform national registration system," Pennsylvania Stone, questioned read exclusivity. 75, his concern diminished driven "own conceptions ha[d] inferred enacted." view, "denie[d] practicable identifying alien residents recording whereabouts." Yet, employed override alien-registration "at conflict[ed] [was] *1213 harmonious it." 79, 399.[4] 2 consequences approach exemplified incorporate today. 13-14; 1220-1222 ALITO, Traffic Vehicle Safety 1966 (Safety Act), 80 718, 15 1381 (1988 ed.), Standard "required auto equip 1987 vehicles restraints." 864-865, plaintiff claimed equipped automobile airbags. 865, together, expressly 867-868, 1913.[5] "obstacle" large comments promulgating brief restraints. 874-886, "deliberately provid[e] manufacturer[s] devices" "bring gradually time," *1214 "why objectives," brief, "`embod[ying] Secretary's promoted installed alternative systems fleets car,'" O.T.1999, 98-1811, 25); 883-884, "ex post administrative inferences commentary," 910-911, cars "install systems" have, "presented sought" gradually, apply positions flawed, plain explicitly preserved "[c]ompliance motor vehicle subchapter exempt law," 1397(k) ed.).[6] Engine South Coast Air Quality Management Dist., 541 246, 252, 1756, 158 (2004) ("Statutory begin accurately expresses purpose" omitted)); West Virginia Univ. Hospitals, Casey, 499 83, 98, 1138, (1991) statute] Houses President"). divined lawto systemsin invalidate *1215 State's imposition goal reduce traffic accidents deaths injuries accidents," ed.). plain, enforced according Jimenez Quarterman, 555 681, 172 475 (2009); also, Dodd 545 353, 359, 2478, 162 343 (2005); Lamie Trustee, 540 526, 534, 1023, 157 1024 (2004); Hartford Underwriters Ins. Planters Bank, N. A., 6, 1942, addressed end matter; court, agency, unambiguously Home Builders Defenders Wildlife, 551 127 2518, 2534, 168 467 omitted). allowed comb commentaries conclusion. Applying vacate another assumptions goals untethered authorizing Watters Wachovia 550 44, 1559, 167 389 "affects allocation sovereigns"). "`[A]n [law] it.'" 1012 Louisiana Pub. Serv. Comm'n FCC, 476 355, 374, 106 1890, (1986)). Member musing intentions 1206-1208. problematic encourages expansive divine broader inevitably leads assume wanted pursue costs"even balance. 904, notion advance costs"); L.Rev., 279-280. noted, "`it frustrates effectuates simplistically furthers statute's objective law.'" E.g., Norfolk Southern Sorrell, 549 158, 171, 799, 166 638 Rodriguez 480 522, 1391, 94 (1987) (per curiam)). often compromise legislators "groups marked divergent interests." Ragsdale Wolverine World Wide, 81, 93-94, 1155, (2002). extents. Family Leave 12 work-weeks *1216 yearly "was compromise" courts); Silkwood Kerr-McGee 238, 257, 104 615, 78 443 (1984) allegedly frustrated Atomic Energy furthered extent `with public'" 42 2013(d) (1982 ed.))); Manning, What Divides Textualists Purposivists? Colum. (2006) ("Legislators fully address mischief, accepting half loaf facilitate enactment"). seemingly warrants preemptive general, accords actually effectuated majority, reaching demonstrates matters proper heavily "during history" addresses 1200. "silence [Congress'] litigation," reasons, (construing "[e]vidently [had] relief"). Certainly, absence pre-empting lawsuits relevance lawsuits, draw motivations act. Brown Gardner, 513 115, 121, 552, 130 (1994) ("[C]ongressional lacks persuasive significance" O'Melveny Myers FDIC, 512 85, 114 2048, ("[M]atters left unaddressed [a detailed federal] presumably disposition law"); Newfound, 616, 1590 ("[O]ur rejects believed drug-approval conclusion, compelled provisions, suppositions unstated goals. reaches justify inaction. *1217 shows willingness guess easily perceptions unduly Garamendi, 539 396, 401, 405-408, 429, 2374, 156 376 pass disagreed President's executive agreement supported, part, determination Either illegitimate. Clause, 2not considerations Hoffman Connecticut Dept. Income Maintenance, 492 104, 2818, (plurality opinion) arguments "are statute... helpful"); TVA Hill, 437 194, 98 2279, 57 (1978) ("Our appraisal wisdom unwisdom course consciously selected put aside process interpreting statute"). role, interpret statute[s] Barnhart Sigmon Coal 534 438, 461, 941, 151 908 origins illustrate facilitates freewheeling, extratextual, evaluations This, turn, giving judicially manufactured policies, thereby. illegitimateand thus, unconstitutionalinvalidation assent "stan[d] respectfully whom THE CHIEF JUSTICE SCALIA join, dissenting. illustrates tragic facts bad holds jury, (FDA), ultimately reconciled (2000), dissent. frames "narro[w]" onenamely, "an method" 1194. ignores antecedent whothe Vermont "adequacy" unclear "stronger" helped respondent, 1199; *1218 all, physician's disregarded six hard pressed seventh difference.[1] point, "narrow" one, warning. real countermand FDA-mandated renders (IV) "safe." complaint administration," 15, ¶ 6; attorney told "`Do intravenously,'" 32; "I think labeled `Not use,'" 59; closing "Thank God don't safe[ty] decision. You decision.... doesn't decision, you do," 211-212.[2] push particular. Whether wisely not, concludedover extensive, 54-year-long proceedingsthat "safe" "effective" unfortunate healthcare providers ignored ideal medical-malpractice case.[3] turning suit "frontal assault" regime upsets well-settled 21. *1219 case," "purpose" FDAnot juriesto approving rigorous devices," 1018, latter device "safe," 1018 Court). submitting (NDA) 355(a). NDA contain, drug," 355(b)(1)(F), "full use," 355(b)(1)(A), exceed drug] labeling," 314.50(d)(5)(viii) approve finds, thereof," "false misleading particular." 355(d). remains investigate events 314.80, periodically affect conclusions 355(k). "shall" 355(e). "misbranded" manner, duration thereof." 352(j). "serves determines effective." 7470 Labeling centerpiece management," "communicates practitioners formal, authoritative safely effectively." 3934 underscored places regulationsspanning Regulations, pt. 201, seven subparts 70 sectionsthat manufacturers' obligations. contains, needed 201.56(1), *1220 description "clinically reactions," "other potential hazards," "limitations them, steps occur," 201.57(c)(6)(i). Neither implementing second-guess decisions. Where determines, mandate, countermanding determination. Buckman Plaintiffs' Legal Comm., 531 341, 348, 148 854 (2001) (after struck somewhat valid device, negate it); International Paper Ouellette, 479 481, 494, 805, 883 EPA private interests carefully by" permitting water pollution, nuisance "upse[t]" Chicago North Western Transp. Kalo Brick Tile 450 311, 321, 101 1124, 258 (1981) Interstate Commerce Commission "balance" abandonment railroad line, it). recognizes, irrelevant "enacted history." 1200; 869, (holding "does bar working principles"). solely upset agency. 884-885, 317, 1124 two-step ascertaining [federal laws] faithful compels 40-year-long effort regulate efficacy suit. follows arose 1966, directs standards," 1392(a) defined "minimum standard[s] performance, equipment performance," 1391(2). Acting automatically occupants collision) percentage built 1987. 49 571.208 (1999). 208 installation restraint; option automatic *1221 seatbelts, suitable technology develop, restraint(s) met performance specified rule. Alexis drove Accord tree, although wearing seatbelt, suffered injuries. She sued alleging negligently defectively designed driver's-side airbag. empowered standard[s]" safety. emphasized 1397(k). Notwithstanding "minimum" standards, Geier's Transportationexpressed briefthat "`embodies car.'" Curiae, 25). menu technologies barred efforts alternatives "unsafe" rationale Through professionals approved, alternativesincluding pushfor suit, "ineffective." sure, push, installing compel latter, too, precluded compelling former. 155, (1982) evaporate [agency's] permits, compel," forbidden anything, here FDCAunlike Actcontains clause.[4] *1222 1200 (conceding "silence" issue). evade applicability commits errors. matter, demonstrably untrue (and between) costs push. espoused dissenters majority) Third, undermines workability drug-labeling strict 1950's. focused decisionto albeit stringent warningsis reflected (sometimes boldfaced font all-capital letters). ample reconsidered strength IV-push-related data. assertions mistaken. focus dates back 1975. year, several representatives discuss At meeting, "that Injection Tubex reg;." Record 583, 586 (Plaintiff's Trial Exh. 17, Internal Correspondence W.E. Langeland File (Sept. 1975) 1975 Memo)). "Tubex" syringe exclusively 43. official Memo 586, aware "5 together necrosis," 586-587. Rather agreed better problems intraarterial injection." 587. convened advisory committee study, 294. recommended IV-push-specific recommend altogether. committee's recommendations, upper 279-280, 282-283. *1223 directed amend text: "`[1] [Phenergan] concentration 25 mg/ml rate mg/minute. [2] running enhance possibility detecting placement.'" 311-312. sentences refers push; testified trial, label's (not mg per minute) "IV opposed dripped couple hours." 52. drip. 15-16 (emphasizing "running IV" thing drip"). order, voluminous materials "suppor[t]" preferability drip.[5]Id., 313. One articles discussed relative advantages disadvantages compared via push.[6] published 1960's caused Phenergan,[7] latest research.[8] studied cautionary articlesone urged *1224 altogether.[9] "support" singled inner crook elbowknown "antecubital fossa" communitywhich commonly site, pushed antecubital space"), universally high-risk area injections. explained: "Because superficial ulnar occupy, venipuncture fossa].... However, brachial radial arteries elbow region.... variations arm, cubital fossa, numerous. area, index suspicion forestall misdirected injections." Stone Donnelly, Accidental Intra-arterial Thiopental, 22 Anesthesiology 995, 996 (1961) (footnote 315, no. 20).[10] *1225 research, ordered space push.[11] passages lieu above). "aspiration," technique conjunction push.[12] cautioned "syringes rigid plungers," "by talking plungers needles, that's way it, plunger." 53 (testimony Dr. John Matthew). 2000 devoted page "Tubex 391, which, above, clearly delivery resort. preferred parenteral route deep 390. ineffective, satisfactorily." 50-51 expert, Matthew) satisfactorily drip). Finally, reason chooses he "INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF AFFECTED EXTREMITY." 391; 390 ("Under due likelihood severe arteriospasm resultant gangrene"). choose veins push: "Due close proximity areas extreme exercised avoid Reports compatible Injection, use, pain, chemical irritation, spasm distal vessels, likely circumstances." "labeling *1226 1192. else said extensive "paid to" 1193; weigh benefits, Respondent 50. dispute "in swift timely way" up hospital complaining "intractable" migraines, "terrible pain," inability "bear sound," sleeplessness, hours-long spasms "retching" "vomiting," "every possible" "failed." 40 Matthew); Jessica Fisch). disputing complains underestimated hence risks). read, EXTREMITY," "[u]nder injection," intra-arterially. effectively"). Unfortunately, single spot arm textbook knowledge high arteries. 1224-1225; Lippincott Manual Nursing Practice 99 (7th ed.2001) (noting, red-text "NURSING ALERT," fossa recommended" "due extravasation").[13] According crossed mind" hit 110; ("[It] wasn't something time"). Oblivious warnings, "[p]robably three four minutes," 111; 105, complaints "`burn[ing]'" sensation subsequently "`one pains I've ever felt,'" *1227 110, 180-181. asked stop pushing burning pains, "just crazy" "worr[y] [intra-arterial] injection" circumstances, 111. pushespecially spacewere crazy." warns them. Given (like one) yesterday's today's denies existence federal-state countermanded concludes "mandate particular" "replacement" nullified, stopped short altogether "contraindicating (over dissent's contrary), degree intrusion irrelevantthe equal countermands selling Compare 881-882, 902, dissenting). Term, "[s]tate catheters safer, less model approved...." 1008. prohibiting cathetersjust 504, "anomalous result" differently inadequacy design). today distinguishes "without comment." 1201; (again case) notice-and-comment rulemaking. 885, ("To insist expression pre-empt, rulemaking, unlikely intended. said, apparently welcomes .... not"), 908-910, expect declare intention *1228 specificity," expectation able dialog ex ante normal Administrative Procedure Act" arguably (unlike DOT) Register. 3933-3936. dismisses "inherently suspect," 1201, afterthought weight," 1204. "special which) translate understandings particularized `regulations, preambles, interpretive statements, responses comments'"). "bear[s] whereas 1203; law" do. 355. discretion adjudications less-formal less-flexible SEC Chenery 1575, 1995 (1947), turns choice outcome hinged promulgate 1200, reliedagain dissenters' protestationson explain 899-900, 1204 Fourth, sandwiches "presumption pre-emption," heavy emphasis remedies," pre-emption" 906-907, ("[T]he [against pre-emption]"). "presumption," applying "ordinary," "longstanding," "experience-proved sole law; 871-872, Buckman, 347-348, ("[P]etitioner's dealings prompted law], petitioner's [to FDA] dictated law]. Accordinglyand contrast situations implicating `federalism primacy safety'no *1229 obtains case" (citation omitted)).[14] (yet objections) placed effects compare "uph[olding] frustration-of-purposes commentary"). 496, (recognizing "uniquely qualified" objectives). today, regime, mentioned Instead decade-old now-repudiated statement, preferable. 1201-1202, 1203, 13. 1010 describes length preferable) compromised, indeed deprived deference, position" Altria Group, Good, 538, 549-550, L.Ed.2d (rejecting petitioners' "longstanding policy" one). BREYER "help [FDA]," (concurring opinion), insistence "disrupt benefits," 9. countenance potentially C nature, ill-equipped perform cost-benefit-balancing function. tend *1230 product's contributed injury, overall patients reaped court." ones see, patient respondentwho accidentPhenergan's probabilities potentialities. benefit view. users "those suffer [products]" free contradict determinations. 1009. conveys voice, whipsawing community more) ones. ruling, parochialism prevail. illustrated borne "vesicant" chemotherapy. class, vesicants Phenergan,[15] vast vesicant labelslike Phenergan'seither allow disallow Appendix, infra. devastating consequences, lifesaving offer hollow solace victim tragedy, cost-benefit differ FDA's. Mustargen (mechlorethamine HCl)the mustard gaswhich anticancer Mustargen's HIGHLY TOXIC."[16] highly toxic: "Should accidental eye copious irrigation minutes water, balanced salt ophthalmic irrigating instituted immediately, followed prompt ophthalmologic consultation. Should skin affected irrigated immediately removing contaminated clothing shoes, 2% sodium thiosulfate solution. immediately. Contaminated destroyed."[17] comes toxic [but] preferably rubber plastic flowing set. reduces reactions (Emphasis added.) Similarly, chemotherapeutic vesicantsincluding *1231 Dactinomycin, Oxaliplatin, Vinblastine, Vincristinespecifically extravasated. strikingboth frequently extravasated, Boyle Engelking, Vesicant Extravasation: Myths Realities, Oncology Forum 57, 58 (1995) (arguing "considerably higher" 6.4% administrations). Regardless odd (to least) chosen gas.[18] * peacefully coexist decades. 1199-1200. peaceful said: "Not so." squarely reverse Vermont. APPENDIX TO OPINION ---------------------------------------------------------- Vesicant[1] Push[2] Dactinomycin Specifically Mechlorethamine (Mustargen) Oxaliplatin Vinblastine Vincristine Bleomycin Carboplatin Dacarbazine Mitomycin Carmustine prohibited; Cisplatin Epirubicin Etoposide Ifosfamide Mitoxantrone Paclitaxel Teniposide Vinorelbine Daunorubicin Prohibited Doxorubicin NOTES [1] "Inadvertent Injection" stated: circumstances. Intravenous reported placement suspect. proven successful management condition occurs.... Aspiration dark blood placement, discolored Injection. Use syringes small bore needles obscure typical backflow alone. mL minute. satisfactorily. extravasation." malpractice 1217 ("[I]t `stronger' respondent"); 1225-1227 assistant's injury). frustration merits decidewhether [3] regulated century. misunderstands principle: "independent system" "Congress cavalierly action." (1996). presence 1228, California ARC 490 93, 101-102, 1661, (1989); 716, (1985); Rush Prudential HMO, Moran, 536 387, 2151, 153 (2001), 1229, 14, curious, fraud-on-the-agency distinguished apply. [4] Pfizer Vistaril, antinausea amputations. 79. [5] event, adapted revisions 339-341, wording During strongly material 189 ("Simply stated, different, stronger. prominent original ..."); 248-250. concedes substantively different: "[I]t viewed non-substantive formatting reasons." 25; 189. [6] suggestion fairly record. creatively paraphrases ordersfor instance conflating 1222, 1223-1224, 1225-1226to question, undertakes study elaborate order. [7] consumers, H.R. 6110, 73d (1933) introduced), witnesses Hearings S.1944 Subcommittee Committee Commerce, 400 (statement W.A. Hines); 403 J.A. Ladds) restate injuries"). [8] 1997, over-the-counter medications cosmetics actions. 379r(e), 379s(d) ("Nothing construed otherwise State"). [9] examples, 253(a), (d) (2000 ed.) Communications "any statute, requirement" "may entity intrastate telecommunications service"); 30 1254(g) (2006 (pre-empting chapter" Interior "set preempted superseded"); 5125(d) ed. Supp. V) hazardous waste transportation pre-empted). [10] 44 37437 (1979) influence civil manufacturer"); 59 Reg. 3948 ("[P]roduct plays important protection"); Porter, Lohr Decision: Perspective Position, L.J. (former chief counsel stating complementing mission protection). [11] 1955, year "conclusively" budget staff responsibilities public." Citizens Advisory Report Health, Education, Welfare, Doc. 84th 53. Three reached conclusions. Science Board, Technology: Mission Risk 6 (2007), online http://www.fda.gov/ohrms/dockets/ac/07/briefing/ XXXX-XXXXb_02_01_FDA%20Report%20on%20Science%20and%20 Technology.pdf (all Internet visited Feb. 23, 2009, Clerk file) Agency suffers deficiencies positioned meet emerging responsibilities"); Academies, Institute Medicine, Future Safety: Promoting Protecting Health Public 193-194 [FDA] accomplish mission.... widespread resource hobbled improve component mission"); GAO, Improvement Needed Postmarket Decision-making Oversight Process 5 (GAO-06-402, 2006), http:// www.gao.gov/new.items/d06402.pdf ("FDA about, of, postmarket issues"); House Reform, Majority Staff Report, Career Objected Preemption Policies scientists career officials preemption preamble] erroneous accurate up-to-date labels"). [12] Former Commissioners Drs. Donald Kennedy Kessler Amici Curiae; Vladeck, Critical Examination Efforts Preempt Failure-To-Warn Claims, 96 Geo. 463 (2008); 451, "can catalyst" aiding exposure prompting required). [13] States' similarly undeserving Unlike manner accounts, departs markedly [14] contentionthat resembles needed, thereby setting labelis belied discussed, 249-250 little issues trial"). powers. Expansion "increasingly generous erase diffusion Nation faith efficiency vitality Republic." Garcia San Antonio Metropolitan Transit Authority, 469 528, 583-584, 1005, 1016 (O'Connor, Marbury Cranch 137, 176, (1803) legislature defined, limited; limits mistaken, forgotten, written"). 1194, evident themselves below whether, extent, express-pre-emption clause. 551-552, required: 18 years over, exceptions, register year; plus `other details' Labor Industry direct; pay $1 annual fee; receive identification card carry times; whenever demanded officer agent Industry; exhibit precedent registering obtaining license one.... Nonexempt fine imprisonment demand, punishment imprisonment...." 14 age over; `such Commissioner, Attorney General'; finger-printing registrants; secrecy files.... No exhibited others wilful criminal offense...." 60-61, resembled "`occupied field,'" simple principles. (dissenting opinion). observed assessing boundaries lawi.e., effect look itself, speculate intentions. 78-79, 616-617, "field suspect, command pre-empted"). part: "Whenever effect, establish, item equipment[,] applicable aspect identical standard." 1392(d) "Compliance import 895-898, impropriety looking evaluate assessed out, "`to accidents.'" 888-889, ed.)). face, death accidents. definition minimum, fixed maximum, 903, 1391(2) ceilings, "obvious favored rapid increase" regulations. acted airbag car. 903-904, risks. Plaintiff Memorandum Opposition Motion Summary Judgment Products Corp. (now Wyeth), 670-12-01 Wncv (Super. Washington Cty., Vt.), 26. Specifically, noted: "In accident explaining injection]." 24 ("Although strong enough, improved instruction, followed, ..."). proposal. judge's charge, decide" patients." 220. 182 "label administration"). physician, assistant, malpractice. settled undisclosed sent admitted "responsibility" "profoun[d] regre[t]" "remors[e]" 178-179 (Mar. 2004) 102-103 Fisch) "sense grief" "great" "would gladly cut off [her own] arm" respondent). Thereafter, testify behalf Wyeth. Amendments 793 invalidating recognizes "saving clause," were, displace conflict-pre-emption principles"); 873-874, refused `saving' actual `frustration-of-purpose' cases" deleted Nahrwold Phelps, Inadvertent Intra-Arterial Mephenteramine, Rocky Mountain 38 (Sept.1973) (cited 314, 14); Albo, Cheung, Ruth, Snyder, Beemtsma, Injections Barbituates, Am. Surgery 676 (1970) 12); Corser, Masey, Jacob, Kernoff, Browne, Ischaemia Following Self-administered Methylphenidate Diamorphine, 51 9); Regarding Thiopental Thiamylal (3 letters), 11); Miller, Arthur, Stratigos, Barbituate, 23 Anesthesia Progress (1976) 19). Webb Lampert, Arterial Injections, Obstetrics Gynecology 365 (1968) 313, 5). Hager Wilson, Gangrene Hand Archives (1967) 7); Enloe, Sylvester, Morris, Hazards Hydroxyzine, 16 Canadian Anaesthetists' Society 425 (1969) Enloe) "recent occurrence necrosis [administration of] (Phenergan reg;)" 15)). Mostafavi Samimi, Promethazine HCl General Anesthesia, 35 645 (1971) (reporting partial fingers, "antecubital" area); Promethazine, Clinical Pharmacology (Gold Multimedia CD-ROM, 1.16 "[i]nadvertent Phenergan] gangrene")). Wilson injections "[i]mmediate, severe, "blanching." Surgery, 87-88. Wilson's observations 311 "`[t]he sign injection] reaction fiery burning'" "`[b]lanching'"). Enloe 427 hydroxyzinean properties Phenerganand suggesting "temporary" outweigh injection); Goldsmith Trieger, Injection: Emergency, 180 (1975) hydroxyzine) 18); Klatte, Brooks, Rhamy, Toxicity Barbituates Tranquilizing Drugs, Radiology (same) 13). risks, retained article precaution obviously well-functioning venoclysis"), (FDA's label). around 1970, hydroxyzine. 79 Harold Green). differentlynotwithstanding (1) (2) hydroxyzine-related Phenerganfurther intentionally Haas, Correspondence, 33 281 (1986) ("[Hydroxyzine's] restriction lie medicine practice techniques. practitioner knows problems"). Engler, Freeman, Kanavage, Ogden, Moretz, Production Gangrenous Extremities Surgeon 602 (1964) ("Accidental occurs region favorite site venopuncture entered" 6)); Resulting 644 (1966) (similar) 16); Lynas Bisset, Thiopentone, Anaesthesia 257 ("Most [anesthesiologists] medial avoided" 8)); Waters, 346 producing forearm thiopentone recognised years" 10)); 88 prevent "aberrant antecubital, forearm, wrist, level"); supra (warning injections). "`[b]eware sites aberrant arteries'"). "Aspiration" drawing amount Ordinarily, brighter venous bloodbut discoloration, aspiration unreliable 282. beware "[a]spiration Injection." principle "basic anatomy" 34-35 9, Daniel O'Brien); Gray's Anatomy, Bible anatomy," space). true "this long" cases. 1195, (majority ago Gibbons 9 210, (1824), inquired "interfer[ed] with," "contrary to," "c[a]me collision with" lawand "presumption." Davis, Unmasking Presumption Favor S.C.L.Rev. 967, 974 early "resulted regulation"). open questionbefore todaywhether ("We consideration context preemption"). "presumption" areasuch labelingthat "reserved 111, (2001). [15] Vesicants "blistering, necrosis" extravasationeven Schulmeister, Administering Vesicants, 469, 469-470 (2005). 1192 "irritant"); Anju Budhwani al. "vesicant"). [16] Tools Label Details, http://www.accessdata.fda.gov/ scripts/cder/onctools/labels.cfm?GN= meclorethamine,% 20nitrogen% 20mustard Mar. file). [17] [18] supra. Wilkes Barton-Burke, Handbook 27-33 (Table 1.6). derived "dosage administration" (available

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