Legal Document

128 S. Ct. 999 (2008) Donna RIEGEL, individually and as administrator of the Estate Charles R. Riegel, Petitioner, v. MEDTRONIC, INC. No. 06-179. Supreme Court United States. Argued December 4, 2007. Decided February 20, 2008. *1002 Allison M. Zieve, Washington, DC, for petitioner. Theodore B. Olson, D.C., respondent. Edwin Kneedler, States amicus curiae, by special leave Court, supporting Wayne P. Smith, Schenectady, NY, Counsel Record, Brian Wolfman, Scott L. Nelson, Public Citizen Litigation Group, Petitioner. Kenneth Geller, David Gossett, Andrew E. Tauber, Mayer Brown LLP, Matthew D. Mcgill, Amir C. Tayrani, Dace A. Caldwell, Gibson, Dunn & Crutcher Respondent. Justice SCALIA delivered opinion Court. We consider whether pre-emption clause enacted in Medical Device Amendments 1976, 21 U.S.C. § 360k, bars common-law claims challenging safety effectiveness a medical device given premarket approval Food Drug Administration (FDA). I A The Federal Food, Drug, Cosmetic Act (FDCA), 52 Stat. 1040, amended, 301 et seq., has long required FDA introduction new drugs into market. Until statutory enactment at issue here, however, devices was left largely to supervise they saw fit. See Medtronic, Inc. Lohr, 518 *1003 U.S. 470, 475-476, 116 2240, 135 Ed. 2d 700 (1996). regulatory landscape changed 1960's 1970's, complex proliferated some failed. Most notably, Dalkon Shield intrauterine device, introduced 1970, linked serious infections several deaths, not mention large number pregnancies. Thousands tort followed. Bacigal, Limits Litigation: Controversy 3 (1990). In view many, failure its aftermath demonstrated inability system manage risks associated with dangerous devices. See, e.g., Foote, Managing Arms Race 151-152 (1992). Several adopted measures, including California, which 1970 law requiring Cal. Stats. ch. 1573, §§ 26670-26693; see also Leflar Adler, Preemption Pentad: Products Liability Claims After 64 Tenn. L.Rev. 691, 703, n. 66 (1997) (identifying 13 state statutes governing 1976). Congress stepped passage 1976(MDA), 360c seq.,[1] swept back obligations imposed regime detailed federal oversight. MDA includes an express provision that states: "Except provided subsection (b) this section, no State or political subdivision may establish continue effect respect intended human use any requirement "(1) is different from, addition to, requirement applicable under chapter "(2) relates other matter included chapter." 360k(a). exception contained permits exempt local requirements from pre-emption. established various levels oversight devices, depending on present. Class I, such elastic bandages examination gloves, subject lowest level oversight: "general controls," labeling requirements. 360c(a)(1)(A); FDA, Advice: Classes, http://www.fda. gov/cdrh/devadvice/3132.html (all Internet materials visited Feb. 14, 2008, available Clerk Court's case file). II, powered wheelchairs surgical drapes, ibid., "special controls" performance standards postmarket surveillance 360c(a)(1)(B). receiving most are those III, include replacement heart valves, implanted cerebella stimulators, pacemaker pulse generators, supra. general, assigned III if it cannot be less stringent classification would provide reasonable assurance effectiveness, "purported represented sustaining life substantial importance preventing impairment health," "presents potential unreasonable risk illness injury." 360c(a)(1)(C)(ii). *1004 Although rigorous grandfathered many were already Devices sold before MDA's effective date remain market until promulgates, after notice comment, regulation approval. 360c(f)(1), 360e(b)(1). related seeks limit competitive advantage receive. need undergo finds "substantially equivalent" another 360c(f)(1)(A). agency's review equivalence known 510(k) process, named section describing review. enter through 510(k). 2005, example, authorized marketing 3,148 granted just 32 Hutt, Merrill, Grossman, Law 992 (3d ed.2007). Premarket "rigorous" process. U.S., 477, 2240. manufacturer must submit what typically multivolume application. AdvicePremarket Approval (PMA) 18, http://www.fda.gov/cdrh/ devadvice/pma/printer.html. It includes, among things, full reports all studies investigations device's have been published should reasonably applicant; "full statement" "components, ingredients, properties principle principles operation"; "a description methods used in, facilities controls for, manufacture, processing, and, when relevant, packing installation of, device"; samples components FDA; specimen proposed labeling. 360e(c)(1). Before deciding approve application, agency refer panel outside experts, CFR 814.44(a) (2007), request additional data manufacturer, 360e(c)(1)(G). spends average 1,200 hours reviewing each supra, grants only there "reasonable assurance" "safety effectiveness," 360e(d). "weig[h] probable benefit health against injury use." 360c(a)(2)(C). thus present great nonetheless offer benefits light alternatives. approved, Humanitarian Exemption procedures, ventricular assist children failing hearts, even though survival rate using than 50 percent. Center Radiological Health, Summary Safety Probable Benefit 20 (2004), online http://www.fda.gov/cdrh/pdf3/H 030003b.pdf. process evaluates conditions set forth label, 360c(a)(2)(B), determine neither false nor misleading, 360e(d)(1)(A). completing review, grant deny condition adherence standards, 861.1(b)(3), restrictions upon sale distribution, compliance requirements, 814.82. *1005 free impose device-specific regulation. 360j(e)(1). If unable form, send "approvable letter" indicating could approved applicant submitted specified information agreed certain restrictions. 814.44(e). Alternatively, "not approvable" letter, listing grounds justify denial where practical, measures undertake make approvable. 814.44(f). Once received approval, forbids make, without permission, changes design specifications, manufacturing processes, labeling, attribute, affect effectiveness. 360e(d)(6)(A)(i). wishes change, submit, approve, application supplemental evaluated same criteria initial 360e(d)(6); 814.39(c). reporting 360i. These obligation inform clinical scientific concerning knows know 814.84(b)(2), report incidents caused contributed death injury, malfunctioned manner likely cause contribute recurred, 803.50(a). power withdraw based newly reported existing determines unsafe ineffective 360e(e)(1); 360h(e) (recall authority). B Except otherwise indicated, facts appear Appeals. Evergreen Balloon Catheter marketed defendant-respondent 1994; label approvals 1995 1996. Riegel underwent coronary angioplasty 1996, shortly suffering myocardial infarction. App. Pet. Cert. 56a. His right artery diffusely diseased heavily calcified. Riegel's doctor inserted his patient's attempt dilate artery, although stated contraindicated patients diffuse calcified stenoses. warned catheter inflated beyond rated burst pressure eight atmospheres. five times, 10 atmospheres; fifth inflation, ruptured. Complaint 3. developed block, placed support, emergency bypass surgery. wife brought lawsuit April 1999, District Northern New York. Their complaint alleged Medtronic's designed, labeled, manufactured violated York common law, these defects suffer severe permanent injuries. raised claims. held *1006 pre-empted strict liability; breach implied warranty; negligence design, testing, inspection, marketing, catheter. 68a; 3-4. negligent claim insofar premised theory Medtronic law. 71a. Finally, court concluded preempted loss consortium extent derivative Id., id., 75a.[2] Appeals Second Circuit affirmed dismissals. 451 F.3d 104 (2006). "clearly federal, adhering individual, federally approved" 118. Riegels' because "would, successful, differed added to" 121. certiorari.[3] 551 ___, 127 3000, 168 725 (2007). II Since expressly pre-empts "different ... device" 360k(a)(1), we Government so, then ones, relate turn first question. majority interpreted informed" 808.1(d). 495, 2240; 500-501, That says "only specific counterpart regulations particular device...." Informed regulation, across board almost did pre-empt liability Lohr. said, question reflected "entirely generic concerns about generally." 501, While disclaimed conclusion general never pre-empt, duties pre-empted, *1007 occurred hand careful comparison between issue. Even substantial-equivalence specific, Lohr rejected manufacturer's contention "requirements." regarded fact products entering so equivalents relevant pre-1976 qualification exemption rather requirement. 493-494, 513, 2240 (O'Connor, J., concurring part dissenting part). contrast, imposes "requirements" Unlike duties, individual And sense reviewit Thus, attributes found lacking here. "`focused equivalence, safety,'" 493, (opinion Court), focused safety, equivalence. "never formally reviewed efficacy," offers while does "`require'" allowed equivalent "take form reason," requires made deviations specifications reason determined provides turn, then, second question: rely "any requirement" "relates device." very subjects claims, critical York's constitute MDA. Justices causes action do "requirement[s]" device. 512, O'Connor, joined Rehnquist, THOMAS, JJ.); 503-505, BREYER, J.). adhere view. interpreting two likewise pre-empting duties. Bates Dow Agrosciences LLC, 544 431, 125 1788, 161 687 (2005), actions Insecticide, Fungicide, Rodenticide said "`shall packaging *1008 subchapter.'" 443, 1788 (discussing 7 136v(b); emphasis added). Cipollone Liggett Inc., 505 504, 112 2608, 120 407 (1992), Health Cigarette Smoking 1969, 15 1334(b), "[n]o prohibition smoking shall advertising promotion cigarettes" whose packages labeled accordance 523, 2608 (plurality opinion); 548-549, (SCALIA, judgment entitled meaning will assign terms regularly enactments. Absent indication, reference State's As plurality Cipollone, "premised existence legal duty," therefore establishes defendant state-law obligation. 522, 2608. remedy limited damages, award "`can be, indeed designed potent method conduct controlling policy.'" 521, case, nothing contradict normal meaning. To contrary, context legislation excluding scope little sense. catheters safer, but hence effective, model disrupts scheme effect. Indeed, one think applied juries strict-liability standard, deserving preservation. statute, agency, least expected apply cost-benefit analysis similar experts FDA: How more lives saved which, along greater brings harm? jury, hand, sees cost concerned benefits; who reaped court. BREYER explained implausible meant "grant (to `different to' standards) single jury officials acting administrative legislative lawmaking processes." perverse distinction suggested broad language chose MDA,[4] somersaults create it. dissent narrow pre-emptive term "requirement" *1009 "difficult believe would, remove means judicial recourse" consumers injured FDA-approved Post, 1015 GINSBURG, J.) (internal quotation marks omitted). But, explained, exactly terms. operation seconded committee pain nullification. Connecticut Nat. Bank Germain, 503 249, 253-254, 1146, 117 391 our job speculate congressional motives. indication available text statutesuggests solicitude controlling, overcome Congress's estimation innovations.[5] us, supported position taken regard statute. unnecessary statute itself speaks clearly point If, had ambiguous accorded current deference, correct, post, 1016, 8, thatinasmuch mere Skidmore deference seemingly issuethe degree might reduced earlier different. Swift Co., 323 134, 65 161, 89 124 (1944); Mead Corp., 533 218, 121 2164, 150 292 (2001); Good Samaritan Hospital Shalala, 508 402, 417, 113 2151, 368 (1993). But course (which describes length, 1015-1016, preferable) compromised, deprived longer position. length experience FDCA food color additives. 1016-1018. Two points render draw experiencethat suits unreliable. (1) (as assumes) lawsuits drug additive FDCA. (2) believes, (by hypothesis) permitted additives; if, wanted regimes alike; entire instead wrote applies C Riegels contend underlying negligence, strict-liability, implied-warranty "`requirements,'" maintained "`with devices.'" Brief Petitioner 34-36. Again, 504-505, J.); 514, *1010 JJ.).[6] good reason. bear reading. "may relating 360k(a) (emphasis suit depends "continu[ing] effect" "with Nothing suggests general. argument contrary rests states preemption extend "[s]tate applicability purpose either (e.g., electrical codes, Uniform Commercial Code (warranty fitness)), unfair trade practices devices." 808.1(d)(1). assuming play role defining scope, unambiguous support reading own rule Auer Robbins, 519 452, 461, 905, 137 79 (1997), FDA's put forward care, manner. Amicus Curiae 27-28. according excludes incidentally General unlike fire codes practices, "directly regulate" itself, design. 28. find explanation compelling, since Code, unfair-trade-practice specifically Other portions 808.1, 808.1(d)(1) (though still explain why different). Section 808.1(b) sets rule" "having force (whether ordinance, decision)....." (Emphasis added.) This sentence far comprehensible here aware decision solely *1011 tension regulation's statement adulteration misbranding "ha[ve] establishing substantive 808.1(d)(6)(ii). Surely determination warnings. 808.1(d)(1), allow tortious mislabeling escape objects All all, can add confusion. Neither accepting rejecting proposition properly consulted statute's meaning; directly regulate incidentally; fails alter interpretation outcome concerned. IV 360k(a)(1). 360k prevent providing damages violation regulations; "parallel," recognized parallel 70a-71a, assert notwithstanding 68a. now argue their raises briefs Circuit, raise petition certiorari. decline address instance * For foregoing reasons, Affirmed. STEVENS, judgment. significance fully appreciated years enacted. example objective cover territory actually envisioned authors. cases frequently "it ultimately provisions laws principal legislators governed." Oncale Sundowner Offshore Services, 523 75, 79-80, 118 998, 140 201 (1998). Accordingly, agree GINSBURG's actual history 1014-1018 (dissenting opinion), am persuaded preempt differ. write separately few words *1012 There preenactment suggesting thought remedies impeded development Nor evidence suggest decided injuries Administration-approved outweighed "by innovations." Ante, 1009 Court). policy advanced Congress. GINSBURG persuasively explains, overriding protection consumers, protections. then-recent conflicting rules. 489, (1996) opinion) ("[W]hen primarily problem enforced actions"). reaches encompass types Because rules administered judges, like regulations, define obligations, them unquestionably qualify "requirements."[1] (1992) ("[C]ommon-law sort petitioner duty, difficult say `requirements prohibitions.'... [I]t essence enforce affirmative negative prohibitions" added)). "requirements,"[2] correctly out Moreover, cogent predicated *1013 differ join except Parts III-A III-B. dissenting. 1976 (MDA Act), 90 539, construed cut deeply domain historically occupied clause, 360k(a), holds, spares manufacturers personal alleging flaws once gained (FDA); remedy, instructs, persists regulations." 1011.[1] today's constriction authority. Congress, my view, intend radical curtailment suits seeking compensation defectively Congress' enacting evident. engage Some acted fill void adopting systems responded particularly California's preempting initiatives absent permission. 360k(b). "purpose ultimate touchstone analysis." 516, Courts "long presumed cavalierly action." 485, (1996).[2] starts assumption "the historic police powers [a]re superseded unless clear manifest Congress." Rice Santa Fe Elevator 331 230, 67 91 1447 (1947). "This `the federal-state balance' disturbed unintentionally unnecessarily courts." Jones Rath Packing 430 519, 525, 97 1305, 51 604 (1977) (citation presumption heightened "where bar fields traditional regulation." Conference Blue Cross Plans Travelers Ins. 514 645, 655, 115 1671, 131 695 (1995). Given "primacy matters safety," courts assume "that [those] normally coexist regulations," Hillsborough County Automated Laboratories, *1014 471 707, 718, 105 2371, 85 714 (1985). containing automatically preemption. 449, (2005); tells us supersede modify extent. absence precision, face task determining substance displacement Where open plausible reading, ordinarily "accept disfavors pre-emption." Bates, 1788. "[N]o "Absent indication," states, "reference `requirements' duties." 1008. Regarding MDA, "other indication" "[a]bsent." Contextual convinces me 360k(a)'s inclusion prompt sweeping mine-run relief law.[3] "to 539 (preamble).[4] series high-profile failures extensive propelled adoption MDA.[5] Conspicuous approximately 2.2 *1015 million women 1974. re Dist. Cal., IUD Prods. Litigation, 693 F.2d 847, 848 (C.A.9 1982); ante, 1002-1003. Aggressively promoted safe birth control, 16 deaths 25 miscarriages middle 1975. H.R.Rep. 94-853, p. 8 (1976). By early "more 500 compensatory punitive totaling $400 million" filed. Ibid.[6] publicity attending litigation awareness time consideration, informative sign actions.[7] recognizes "§ 1011. important, help receive nevertheless prove unsafe. further broadly grounded allegations independent numbers defective Silkwood Kerr-McGee 464 238, 251, 615, 78 443 (1984). former chief counsel explained: "FDA's product usually operate independently, significant, yet distinct, layer consumer protection. anticipate protect consumers. thorough fail identify problems presented product. Regulation possible result over time. significant ...." Porter, Decision: Perspective Position, L.J. 7, 11 (1997). Cf. Smiths Industries Systems, Kernats, O.T. 1997, 96-1405, pp. 17-18; Dept. Human *1016 Service, Advisory Opinion, Docket 83A-0140/AP, Letter J. Hile, Associate Comm'r Regulatory Affairs, National Women's Network (Mar. 1984).[8] construction "perverse granting immunity industry that, needed regulation," 487, litigation. authority order remedial inter alia, concludes harm public health" defect "would sufficient eliminate risk." 360h(b)(1)(A). Thus repair replace it, refund purchase price, cease recall 360h(b)(2), (e). prospect ameliorative lends suits. Quite opposite: 360h(d) "[c]ompliance issued relieve person law." anticipates "[court-awarded] economic loss" value FDA-ordered subtracted. Ibid.[9] decades regulating additives seq. contains bearing involving confinement hardly renders irrelevant proper interest welfare. informed, *1017 experience. Starting 1938, preclearance marketed. 505, 1052. FDCA's immunize suits.[10] continued unabated despite nearly four regulation.[11] motivated concern mounted regarding devices.[12] Rather, empower exercise control installed level. 1014, 3; infra, 1018, 14. Between 1938 drugs, noted, commenced 1938. 1958, Additives Amendment, 3, 72 1785, 348. 1960, Color Additive Amendments, 103(b), 74 399, 379e. 1962, expanded *1018 101, 76 781, 321 1968, animal drugs. Animal 101(b), 82 343, 360b. None Acts clause. listed, prominent landscape.[13] At enactment, question, check potentially regimes. Sen. Edward Kennedy al. Amici 10. situation existed passed House Report observed: "In programs. comprehensive Committee Sherman Law. authorizes inspection establishments manufacture Implementation resulted clearance California." 45 added).[14] sum, suppress suits, accounts MDA; figures additives, comparable areas. casts doubt arguments contends, second-guess finding directed. Respondent 42-49. similarly minded. 1008-1009. approving devices.[15] considered *1019 question overwhelmingly suits.[16] Decades indicate, argument, mutually exclusive. Refusing read automatic instant suit. First, "pre-emption provision, foreclose (through implication) possibility conflict preemption." Geier American Honda Motor 529 861, 869, 1913, 146 914 (2000) (brackets internal Freightliner Corp. Myrick, 280, 288-289, 1483, 385 dispositive defense *1020 plaintiff's currently postured, presents occasion take up relies exclusively Second, interpose treat dispositive, factor account jury. Sharkey, Federalism Action: Pharmaceutical Cases Versus Courts, Pol'y 1013, 1024 Restatement (Third) Torts 16(a) (Proposed Final Draft 1, Apr. 6, 2005). States, due care saves urge defenses. Instead, regardless strength barred ab initio. ordered today mandated odds central purpose: safety. reasons stated, hold reverse part. NOTES [1] Unqualified 360 hereinafter sections [2] later summary viz., breached warranty comply standards. 90a. consequently well claim. Ibid. determinations, us. [3] having died, her behalf husband's estate. 552 simplicity's sake, terminology draws refers belonging Riegels. [4] 360k(b), circumstances rarely met exist. invoke 360h(d), orders "shall indicates possibly mean deprive content. guidance not. [5] Contrary STEVENS' contention, 1012, "advance" argument. merely purposes, best [6] opinions dispose assertion too disavowed conclusion, [the MDA's] necessarily precludes `general' ever being pre-empted...." 500, verdicts obey rules, kind. Juries them. jury's induce within "A obeyed; event, verdict, motivates optional requirement." 445, (2005). jury" whatsoever standard conforms differs standard. colorful inaccurate page 12 opinion. (explaining 5(b) positive enactments claims" proceeding analyze "each petitioner's pre-empted"); 443-444, (noting 136v(b) judge-made pre-emption," satisfied pre-emption). holding reach important bounds case: preemptive comes receives part, spoke plurality. Unless citations conveying next allows subdivisions stringent" necessitated "compelling conditions." prescription concerns, embodied 360k(b) show homed parties recourse Introducing bill Senate, sponsor "The written always consumer. pays malfunctions." Cong. Rec. 10688 (1975) (remarks Kennedy). (1976) ("Significant cardiac pacemakers 34 voluntary recalls pacemakers, 23,000 units, 1972."); S.Rep. 94-33, 6 (1975), U.S.Code Admin.News 1070, 1076 ("Some 10,000 recorded, 731 death. 512 300 attributed valves; 186 pacemakers; 8,000 devices."); 122 5859 Rep. Waxman) ("A 10-year death-certificate search 850 tied 10689-10690 Nelson). 476, "thousands healthy women." Vladeck, Failure, 33 Pepperdine 95, 103 October 1984, settled litigated 7,700 cases. Sobol, Bending Law: Story Bankruptcy 23 (1991). [7] "[N]othing hearings, Reports, debates," "suggest[ed] proponent distributors result, hint spectacularly odd, Members both Houses acutely ongoing litigation." 491, Adler Mann, Devices: Run Amok, 59 Mo. 895, 925 (1994) ("To mentioned criticize place. note how protections needed."). [8] recently announced brief. 16-24. An brief entitled, most, (1944). 229-233, (2001). weight "depend[s] thoroughness evident validity reasoning, consistency pronouncements, factors give persuade, control." 140, 161. Mead, 228, 2164 (courts consider, "consistency" "persuasiveness" position); (1993) ("[T]he assessing due."). long-held better comports protections, weight. [9] regards unenlightening "could pre-empted" "provides statelaw not." 1008, 4. operative construing 1003-1004, perceived lack "guidance" favor. [10] witnesses testified, "[a] exist[ed]." Hearings S.1944 Subcommittee Senate Commerce, 73d Cong., Sess., 400 (1933) (statement W.A. Hines). 403 J.A. Ladds) ("This act restate injuries."). [11] defendants, appears, Salmon Parke, Davis 520 1359 (C.A.4 1975) (North Carolina law); Reyes Wyeth Labs., 498 1264 (C.A.5 1974) (Texas Hoffman Sterling 485 132 (C.A.3 1973) (Pennsylvania Singer 461 288 (C.A.7 1972) (Indiana McCue Norwich Pharmacal 453 1033 (C.A.1 (New Hampshire Basko 416 417 (C.A.2 1969) (Connecticut Parke-Davis Co. Stromsodt, 411 1390 (C.A.8 Dakota 399 1968) (Montana Roginsky Richardson-Merrell, 378 832 1967) Cunningham Pfizer 532 P.2d 1377 (Okla.1974); Stevens 9 3d 51, 107 Rptr. 45, 507 653 (1973); Bine 422 S.W.2d 623 (Mo. (per curiam). noted defendants interposed plea, unsuccessful. Herman Kline French 286 F. Supp. 694 (ED Wis.1968). 1019, (decisions [12] 704, 71 ("Surely furor aroused suggestion scrutiny regime."); (With preemption, entirely private biologics. disparity justified appropriate, ...."). [13] 1962 reiterated intent relying law: "Nothing amendments... invalidating valid amendments direct 202, 793. [14] featured discussion identified prime candidate "[R]equirements California statute," "serve Secretary authorize (provided meets pursuant bill)." 46. sought terminate systems, place FDA. [15] begins preclinical laboratory testing. submits investigational test humans. 355(i); 312.1 Clinical trials generally proceed three phases successively larger groups patients: 80 phase I; hundred II; thousand III. 312.21. trials, files containing, investigations" showing "drug effective"; drug's composition; manufacturing, packaging; drug. 355(b)(1). [16] Tobin Astra Prods., 993 528, 537-538 (C.A.6 1993); Hill Searle 884 1064, 1068 1989); Vioxx 501 776, 788-789 (E.D.La.2007); Zyprexa 489 275-278 (E.D.N.Y.2007); Weiss Fujisawa 666, 676 (E.D.Ky. 2006); Perry Novartis Pharma. 456 678, 685-687 (E.D.Pa.2006); McNellis ex rel. DeAngelis Pfizer, Civ. 05-1286(JBS), 2006 WL 2819046, *5 (D.N.J., Sept. 29, Jackson 432 964, 968 (D.Neb.2006); Laisure-Radke Par Pharmaceutical, 426 1163, 1169 (W.D.Wash.2006); Witczak 377 726, 732 (D.Minn.2005); Zikis 04 8104, 2005 1126909, *3 (N.D.Ill., May 9, 2005); Cartwright 369 876, 885-886 (E.D.Tex.2005); Eve Sandoz IP 98-1429-C-Y/S, 2002 181972, *1 (S.D.Ind., Jan.28, 2002); Caraker Pharmaceuticals 172 1044 (S.D.Ill.2001); Motus 1085, 1087 (C.D.Cal.2000); Kociemba G.D. 680 1293, 1299-1300 (D.Minn.1988). Fed.Reg. 3933-3936 (2006) (preamble discussing laws); Bextra Celebrex Marketing Sales Practices Prod. M:05-1699 CRB, 2374742, *10 (N.D.Cal., Aug. 16, Colacicco Apotex, Needleman 3:03-CV-3074-N, 2004 1773697, (N.D.Tex., 2004); Dusek H-02-3559, 2191804, (S.D.Tex., 2004). cf. 73 2853 rule). soon Levine Wyeth, 2004-384, ___ A.2d 3041078 (Vt., Oct. 27, 2006), cert. granted, 1118, L.Ed.2d 2008 161474 (2008). is: "Whether judgments (`FDA') efficacy Act, necessary Levine, 2007, 06-1249, i.

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