riegel individually administrator estate riegel medtronic argued december decided february medical device amendments mda created scheme federal safety oversight medical devices sweeping back state oversight schemes statute provides state shall establish continue effect respect device intended human use requirement different addition requirement applicable federal law device relates safety effectiveness device matter included requirement applicable device relevant federal law mda calls federal oversight medical devices varies type device issue extensive oversight reserved class iii devices undergo premarket approval process devices may enter market fda reviews design labeling manufacturing specifications determines specifications provide reasonable assurance safety effectiveness manufacturers may make changes devices affect safety effectiveness unless first seek obtain permission fda charles riegel wife petitioner donna riegel brought suit respondent medtronic medtronic catheter ruptured charles riegel coronary artery heart surgery catheter class iii device received fda premarket approval riegels alleged device designed labeled manufactured manner violated new york common law district held mda riegels claims strict liability breach implied warranty negligence design testing inspection distribution labeling marketing sale catheter claim negligent manufacturing insofar claim premised theory medtronic violated federal law second circuit affirmed held mda clause bars claims challenging safety effectiveness medical device marketed form received premarket approval fda pp federal government established requirement applicable medtronic catheter within meaning medtronic lohr interpreted mda provision manner substantially informed fda regulation cfr says state requirements fda established specific counterpart regulations specific requirements applicable particular device federal law premarket approval imposes specific requirements applicable particular device fda requires device received premarket approval marketed without significant deviations specifications device approval application reason fda determined specifications provide reasonable assurance safety effectiveness pp petitioner claims based upon new york requirement respect medtronic catheter different addition federal ones relate safety effectiveness pp negligence claims impose requirement ordinary meaning term see lohr supra cipollone liggett group nothing mda contradicts normal meaning pp ii rejects petitioner contention duties underlying tort claims general duties requirements maintained respect devices petitioner suit depends upon new york continu ing effect general tort duties respect medtronic catheter title cfr mda extend tate local requirements general applicability whose purpose relates either products addition devices unfair trade practices requirements limited devices alter interpretation pp declines address first instance petitioner argument lawsuit raises parallel claims lohr supra affirmed scalia delivered opinion roberts kennedy souter thomas breyer alito joined stevens joined except parts stevens filed opinion concurring part concurring judgment ginsburg filed dissenting opinion donna riegel individually tor estate charles riegel petitioner medtronic writ certiorari appeals second circuit february justice scalia delivered opinion consider whether clause enacted medical device amendments bars claims challenging safety effectiveness medical device given premarket approval food drug administration fda federal food drug cosmetic act fdca stat amended et long required fda approval introduction new drugs market statutory enactment issue however introduction new medical devices left largely supervise saw fit see medtronic lohr regulatory landscape changed complex devices proliferated failed notably dalkon shield intrauterine device introduced linked serious infections several deaths mention large number pregnancies thousands tort claims followed bacigal limits litigation dalkon shield controversy view many dalkon shield failure aftermath demonstrated inability tort system manage risks associated dangerous devices see foote managing medical arms race several adopted regulatory measures including california enacted law requiring premarket approval medical devices cal stats ch see also leflar adler preemption pentad federal preemption products liability claims medtronic rev identifying state statutes governing medical devices congress stepped passage medical device amendments mda et swept back state obligations imposed regime detailed federal oversight mda includes express provision except provided subsection section state political subdivision state may establish continue effect respect device intended human use requirement different addition requirement applicable chapter device relates safety effectiveness device matter included requirement applicable device chapter exception contained subsection permits fda exempt state local requirements new regulatory regime established various levels oversight medical devices depending risks present class includes devices elastic bandages examination gloves subject lowest level oversight general controls labeling requirements fda device advice device classes http internet materials visited available clerk case file class ii includes devices powered wheelchairs surgical drapes subject addition special controls performance standards postmarket surveillance measures devices receiving federal oversight class iii include replacement heart valves implanted cerebella stimulators pacemaker pulse generators fda device advice device classes supra general device assigned class iii established less stringent classification provide reasonable assurance safety effectiveness device purported represented use supporting sustaining human life use substantial importance preventing impairment human health presents potential unreasonable risk illness injury ii although mda established rigorous regime premarket approval new class iii devices grandfathered many already market devices sold mda effective date may remain market fda promulgates notice comment regulation requiring premarket approval related provision seeks limit competitive advantage grandfathered devices receive new device need undergo premarket approval fda finds substantially equivalent another device exempt premarket approval agency review devices substantial equivalence known process named section mda describing review new class iii devices enter market example fda authorized marketing devices granted premarket approval devices hutt merrill grossman food drug law ed premarket approval rigorous process lohr manufacturer must submit typically multivolume application fda device advice premarket approval pma http includes among things full reports studies investigations device safety effectiveness published reasonably known applicant full statement device components ingredients properties principle principles operation full description methods used facilities controls used manufacture processing relevant packing installation device samples device components required fda specimen proposed labeling deciding whether approve application agency may refer panel outside experts cfr may request additional data manufacturer fda spends average hours reviewing application lohr supra grants premarket approval finds reasonable assurance device safety effectiveness agency must weig probable benefit health use device probable risk injury illness use may thus approve devices present great risks nonetheless offer great benefits light available alternatives approved example humanitarian device exemption procedures ventricular assist device children failing hearts even though survival rate children using device less percent fda center devices radiological health summary safety probable benefit online http premarket approval process includes review device proposed labeling fda evaluates safety effectiveness conditions use set forth label must determine proposed labeling neither false misleading completing review fda may grant deny premarket approval may also condition approval adherence performance standards cfr restrictions upon sale distribution compliance requirements agency also free impose restrictions regulation fda unable approve new device proposed form may send approvable letter indicating device approved applicant submitted specified information agreed certain conditions restrictions cfr alternatively agency may send approvable letter listing grounds justify denial practical measures applicant undertake make device approvable device received premarket approval mda forbids manufacturer make without fda permission changes design specifications manufacturing processes labeling attribute affect safety effectiveness applicant wishes make change must submit fda must approve application supplemental premarket approval evaluated largely criteria initial application cfr premarket approval devices subject reporting requirements include obligation inform fda new clinical investigations scientific studies concerning device applicant knows reasonably know cfr report incidents device may caused contributed death serious injury malfunctioned manner likely cause contribute death serious injury recurred fda power withdraw premarket approval based newly reported data existing information must withdraw approval determines device unsafe ineffective conditions labeling see also recall authority except otherwise indicated facts set forth section appear opinion appeals device issue evergreen balloon catheter marketed medtronic inc class iii device received premarket approval fda changes label received supplemental approvals charles riegel underwent coronary angioplasty shortly suffering myocardial infarction app pet cert right coronary artery diffusely diseased heavily calcified riegel doctor inserted evergreen balloon catheter patient coronary artery attempt dilate artery although device labeling stated use contraindicated patients diffuse calcified stenoses label also warned catheter inflated beyond rated burst pressure eight atmospheres riegel doctor inflated catheter five times pressure atmospheres fifth inflation catheter ruptured complaint riegel developed heart block placed life support underwent emergency coronary bypass surgery riegel wife donna brought lawsuit april district northern district new york complaint alleged medtronic catheter designed labeled manufactured manner violated new york common law defects caused riegel suffer severe permanent injuries complaint raised number claims district held mda riegel claims strict liability breach implied warranty negligence design testing inspection distribution labeling marketing sale catheter app pet cert complaint also held mda negligent manufacturing claim insofar premised theory medtronic violated federal law app pet cert finally concluded mda donna riegel claim loss consortium extent derivative claims see also appeals second circuit affirmed dismissals concluded medtronic clearly subject federal requirement adhering standards contained individual federally approved premarket approval application riegels claims successful impose state requirements differed added federal requirements granted ii since mda expressly state requirements different addition requirement applicable device federal law must determine whether federal government established requirements applicable medtronic catheter must determine whether riegels claims based upon new york requirements respect device different addition federal ones relate safety effectiveness turn first question lohr majority interpreted mda provision manner substantially informed fda regulation set forth cfr see also regulation says state requirements food drug administration established specific counterpart regulations specific requirements applicable particular device cfr informed regulation concluded federal manufacturing labeling requirements applicable across board almost medical devices claims negligence strict liability issue lohr federal requirements said requirements specific device question reflected entirely generic concerns device regulation generally disclaimed conclusion general federal requirements never general state duties never held occurred case hand based careful comparison state federal duties issue even though review device specific lohr also rejected manufacturer contention approval imposed requirements regarded fact products entering market may marketed long remain substantial equivalents relevant devices qualification exemption rather requirement see also concurring part dissenting part premarket approval contrast imposes requirements mda interpreted lohr unlike general labeling duties premarket approval specific individual devices sense exemption federal safety review federal safety review thus attributes lohr found lacking review present equivalence safety opinion premarket approval focused safety equivalence devices enter market never formally reviewed mda safety efficacy fda may grant premarket approval determines device offers reasonable assurance safety effectiveness fda device allowed enter market substantial equivalent take particular form particular reason fda requires device received premarket approval made almost deviations specifications approval application reason fda determined approved form provides reasonable assurance safety effectiveness iii turn second question whether riegels claims rely upon requirement new york law applicable catheter different addition federal requirements relates safety effectiveness device matter included requirement applicable device safety effectiveness subjects riegels claims critical issue whether new york tort duties constitute requirements mda lohr five justices concluded causes action negligence strict liability impose requirement federal requirements specific medical device see opinion joined rehnquist scalia thomas jj opinion breyer adhere view interpreting two statutes likewise held provision state requirements duties bates dow agrosciences llc found actions provision federal insecticide fungicide rodenticide act said certain impose continue effect requirements labeling packaging addition different required subchapter discussing emphasis added cipollone liggett group held actions provision public health cigarette smoking act said requirement prohibition based smoking health shall imposed state law respect advertising promotion cigarettes whose packages labeled accordance federal law see plurality opinion scalia concurring judgment part dissenting part congress entitled know meaning assign terms regularly used enactments absent indication reference state requirements includes duties plurality opinion said cipollone liability premised existence legal duty tort judgment therefore establishes defendant violated obligation remedy limited damages liability award indeed designed potent method governing conduct controlling policy present case nothing contradict normal meaning contrary context legislation excluding duties scope make little sense state tort law requires manufacturer catheters safer hence less effective model fda approved disrupts federal scheme less state regulatory law effect indeed one think tort law applied juries negligence standard less deserving preservation state statute regulation adopted state agency least expected apply analysis similar applied experts fda many lives saved device along greater effectiveness brings greater risk harm jury hand sees cost dangerous design concerned benefits patients reaped benefits represented justice breyer explained lohr implausible mda meant grant greater power set state standards addition federal standards single state jury state officials acting state administrative legislative lawmaking processes perverse distinction required even suggested broad language congress chose turn somersaults create dissent narrow scope term requirement grounds difficult believe congress without comment remove means judicial recourse consumers injured devices post opinion ginsburg internal quotation marks omitted explained exactly clause medical devices terms operation law enacted congress need seconded committee report pain judicial nullification see connecticut nat bank germain job speculate upon congressional motives however indication available text statute suggests solicitude injured devices dissent finds controlling overcome congress estimation solicitude suffer without new medical devices juries allowed apply tort law case us fda supported position taken opinion regard meaning statute found unnecessary rely upon agency view think statute speaks clearly point issue however found statute ambiguous accorded agency current position deference dissent correct see post inasmuch mere skidmore deference seemingly issue degree deference might reduced fact agency earlier position different see skidmore swift mead good samaritan hospital shalala course agency earlier position dissent describes length post finds preferable even compromised indeed deprived claim deference fact longer agency position dissent also describes great length experience fdca respect drugs food color additives post two points render conclusion dissent seeks draw experience clause permits tort suits unreliable established dissent assumes tort lawsuits drug additive approval fdca dissent believes clause permits tort lawsuits medical devices hypothesis permitted drugs additives dissent believes congress wanted two regimes alike congress applied clause entire fdca instead wrote clause applies medical devices riegels contend duties underlying negligence claims even impose general duties requirements maintained respect devices brief petitioner majority suggested otherwise lohr see opinion breyer opinion joined rehnquist scalia thomas jj good reason language statute bear riegels reading mda provides state may establish continue effect respect device requirement relating safety effectiveness different addition federal requirements emphasis added riegels suit depends upon new york continu ing effect general tort duties respect medtronic catheter nothing statutory text suggests state requirement must apply relevant device medical devices products actions general riegels argument contrary rests text fda regulation mda clause extend certain duties including tate local requirements general applicability purpose requirement relates either products addition devices requirements general electrical codes uniform commercial code warranty fitness unfair trade practices requirements limited devices cfr even assuming regulation play role defining mda scope provide unambiguous support riegels position agency reading rule entitled substantial deference see auer robbins fda view put forward case regulation refer general tort duties care underlying claims case device designed labeled manufactured unsafe ineffective manner brief amicus curiae according fda regulation excludes requirements relate incidentally medical devices requirements general tort duties care unlike fire codes restrictions trade practices directly regulate device including design find agency explanation less compelling since said general requirements imposed electrical codes uniform commercial code law regulation specifically excludes portions cfr however support agency view application case though still failing explain electrical codes uniform commercial code requirements different section mda sets forth general rule state duties force effect law whether established statute ordinance regulation decision emphasis added sentence far comprehensible fda view application riegels view aware duties established decision duties aware duties relate solely medical devices riegels reading also tension regulation statement adulteration misbranding claims ha effect establishing substantive requirement specific device specific labeling requirement different addition federal requirement ii surely means mda jury determination labeling pacemaker violated state requirement additional warnings riegels reading however allow claim tortious mislabeling escape long claim also brought objects medical devices think add nothing analysis confusion neither accepting rejecting proposition regulation properly consulted determine statute meaning neither accepting rejecting fda distinction general requirements directly regulate regulate incidentally regulation fails alter interpretation text insofar outcome case concerned iv state requirements mda extent different addition requirements imposed federal law thus prevent state providing damages remedy claims premised violation fda regulations state duties case parallel rather add federal requirements lohr see also concurring part dissenting part district case recognized parallel claims see app pet cert interpreted claims assert medtronic device violated state tort law notwithstanding compliance relevant federal requirements see although riegels argue lawsuit raises parallel claims made contention briefs second circuit raise argument petition certiorari decline address argument first instance foregoing reasons judgment appeals affirmed donna riegel individually administrator estate charles riegel petitioner medtronic writ certiorari appeals second circuit february justice stevens concurring part concurring judgment significance provision medical device amendments mda fully appreciated many years enacted example statute whose text general objective cover territory actually envisioned authors cases frequently concluded ultimately provisions laws rather principal concerns legislators governed oncale sundowner offshore services accordingly agree justice ginsburg description actual history principal purpose provision issue case post dissenting opinion persuaded text preempt state law requirements differ therefore write separately add words mda history meaning requirements nothing preenactment history mda suggesting congress thought state tort remedies impeded development medical devices evidence suggest congress decided cost injuries food drug medical devices outweighed solicitude suffer without new medical devices juries allowed apply tort law innovations ante opinion policy argument advanced congress justice ginsburg persuasively explains overriding purpose legislation provide additional protection consumers withdraw existing protections development state premarket regulatory regimes explained need provision conflicting administrative rules see medtronic lohr plurality opinion hen congress enacted primarily concerned problem specific conflicting state statutes regulations rather general duties enforced actions language provision reaches beyond regulatory regimes encompass types requirements rules administered judges like statutes regulations create define legal obligations unquestionably qualify requirements see cipollone liggett group damages actions sort raised petitioner premised existence legal duty difficult say actions impose prohibitions essence common law enforce duties either affirmative requirements negative prohibitions plurality opinion emphasis added although rules qualify requirements correctly points five justices lohr concluded causes action negligence strict liability issue case imposed requirements federal requirements specific medical device moreover agree cogent explanation riegels claims predicated new york duties constitute requirements respect device issue differ federal requirements relating safety effectiveness therefore join judgment opinion except parts donna riegel individually administrator estate charles riegel petitioner medtronic writ certiorari appeals second circuit february justice ginsburg dissenting medical device amendments mda act stat construed cut deeply domain historically occupied state law mda preemption clause holds spares medical device manufacturers personal injury claims alleging flaws design label application design label gained premarket approval food drug administration fda state damages remedy instructs persists claims premised violation fda regulations ante dissent today constriction state authority congress view intend effect radical curtailment state suits seeking compensation injuries caused defectively designed labeled medical devices congress reason enacting evident federal government engage premarket regulation medical devices acted fill void adopting regulatory systems medical devices section responded state regulation particularly california system premarket approval medical devices preempting state initiatives absent fda permission see purpose congress ultimate touchstone analysis cipollone liggett group internal quotation marks omitted courts long presumed congress cavalierly causes action medtronic lohr preemption analysis starts assumption historic police powers superseded unless clear manifest purpose congress rice santa fe elevator assumption provides assurance balance disturbed unintentionally congress unnecessarily courts jones rath packing citation omitted presumption preemption heightened federal law said bar state action fields traditional state regulation new york state conference blue cross blue shield plans travelers ins given traditional primacy state regulation matters health safety lohr courts assume state local regulation related matters normally coexist federal regulations hillsborough county automated medical laboratories federal laws containing preemption clause automatically escape presumption preemption see bates dow agrosciences llc lohr preemption clause tells us congress intended supersede modify state law extent absence legislative precision however courts may face task determining substance scope congress displacement state law text preemption clause open one plausible reading courts ordinarily accept reading disfavors bates ii mda preemption clause state political subdivision state may establish continue effect respect device intended human use requirement different addition requirement applicable chapter device relates safety effectiveness device matter included requirement applicable device chapter absent indication reference state includes duties ante regarding mda however indication bsent contextual examination act convinces inclusion term requirement prompt sweeping preemption claims relief state tort congress enacted mda provide safety effectiveness medical devices intended human use stat preamble series medical device failures caused extensive injuries loss life propelled adoption conspicuous among failures dalkon shield intrauterine device used approximately million women see northern dist dalkon shield iud prods liability litigation ante aggressively promoted safe effective form birth control dalkon shield linked deaths miscarriages middle early lawsuits seeking compensatory punitive damages totaling million filed given publicity attending dalkon shield litigation congress awareness suits time mda consideration find informative absence sign legislative design preempt state tort recognizes prevent state providing damages remedy claims premised violation fda regulations ante remedy although important help consumers injured devices receive fda approval nevertheless prove unsafe mda failure create federal compensatory remedy consumers suggests congress intend broadly preempt state suits grounded allegations independent fda requirements difficult believe congress without comment remove means judicial recourse large numbers consumers injured defective medical devices silkwood former chief counsel fda explained fda view fda product approval state tort liability usually operate independently providing significant yet distinct layer consumer protection fda regulation device anticipate protect safety risks individual consumers even thorough regulation product critical medical device may fail identify potential problems presented product regulation protect possible injuries might result use device time preemption claims result loss significant layer consumer protection porter lohr decision fda perspective position food drug cf brief amicus curiae pet cert smiths industries medical systems kernats pp dept health human services public health service advisory opinion docket letter hile associate regulatory affairs national women health network mar construction perverse effect granting broad immunity entire industry judgment congress needed stringent regulation lohr plurality opinion exemption liability tort litigation mda grant fda authority order certain remedial action inter alia concludes device presents unreasonable risk substantial harm public health notice defect sufficient eliminate unreasonable risk thus fda may order manufacturer repair device replace refund purchase price cease distribution recall device prospect ameliorative action fda however lends support conclusion congress intended largely preempt state suits quite opposite section ompliance order issued section shall relieve person liability federal state law provision anticipates damages economic loss value remedy subtracted congress enacted mda decades regulating drugs food color additives federal food drug cosmetic act fdca stat amended et seq fdca contains preemption clause thus interpretation bearing tort suits involving drugs additives confinement medical devices hardly renders irrelevant proper construction mda preemption provision long history federal state controls drugs additives interest public health welfare congress experience regulating drugs additives informed part provided model regulation medical devices therefore turn examination experience starting fdca required new drugs undergo preclearance fda marketed see stat nothing fdca text legislative history suggested fda preclearance immunize drug manufacturers tort time congress enacted mda state claims drug labeling design defects continued unabated despite nearly four decades fda congress inclusion preemption clause mda motivated concern similar state tort actions mounted regarding medical rather congress included empower fda exercise control state premarket approval systems installed time preclearance federal level see supra infra congress enacted series premarket approval requirements first drugs additives premarket control already noted commenced drugs congress required premarket approval food additives food additives amendment stat amended required premarket approval color additives color additive amendments stat amended expanded premarket approval process new drugs include review effectiveness drug amendments stat amended et seq required premarket approval new animal drugs animal drug amendments stat amended none acts contained preemption clause measures listed like mda enacted personal injury litigation defective products prominent part legal time enactment state regulations required premarket approval drugs additives question preemption clause needed check potentially conflicting state regulatory regimes see brief edward kennedy et al amici curiae different situation existed medical devices congress developed passed mda house report observed absence effective federal regulation medical devices established programs comprehensive state regulation committee aware california adopted sherman food drug cosmetic law law requires premarket approval new medical devices requires compliance device manufacturers good manufacturing practices authorizes inspection establishments manufacture devices implementation sherman law resulted requirement intrauterine devices subject premarket clearance california emphasis added sum state premarket regulation medical devices design suppress tort suits accounts congress inclusion preemption clause mda clause figures earlier federal laws regulating drugs additives installed comparable control regimes areas congress experience regulating drugs also casts doubt medtronic policy arguments reading preempt state tort claims section must preempt state suits medtronic contends congress wanted state juries fda finding medical device safe effective used directed brief respondent similarly minded ante process approving new drugs least rigorous premarket approval process medical courts considered question overwhelmingly held fda approval new drug application preempt state tort decades drug regulation thus indicate contrary medtronic argument congress regard fda regulation state tort claims mutually exclusive iii refusing read automatic bar state tort claims hardly render fda premarket approval medtronic medical device application irrelevant instant suit first provision foreclose negative implication possibility implied conflict preemption geier american honda motor brackets internal quotation marks omitted see also freightliner myrick accordingly medical device manufacturer may dispositive defense identify actual conflict plaintiff theory case fda premarket approval device question currently postured case presents occasion take issue medtronic relies exclusively argue conflict preemption second medical device manufacturer may entitled interpose regulatory compliance defense based fda approval premarket application treat regulatory compliance dispositive regard one factor taken account jury see sharkey federalism action fda regulatory preemption pharmaceutical cases state versus federal courts law see also restatement third torts proposed final draft apr manufacturer present fda approval medical device evidence used due care design labeling product broad reading saves manufacturer need urge defenses instead regardless strength plaintiff case suits barred ab initio constriction state authority ordered today mandated congress odds mda central purpose protect consumer safety reasons stated hold preempt riegel suit therefore reverse judgment appeals relevant part footnotes unqualified et seq numbers hereinafter refer sections district later granted summary judgment medtronic claims riegel found medtronic breached express warranty negligent manufacturing comply federal standards app pet cert consequently granted summary judgment well donna riegel derivative consortium claim ibid appeals affirmed determinations us charles riegel died donna riegel petitioner behalf administrator husband estate simplicity sake terminology opinion draws distinction charles riegel estate charles riegel refers claims belonging riegels riegels point authorizes fda exempt state requirements circumstances rarely met duties law permits agency exempt certain requirements suggest requirements exist riegels also invoke provides compliance certain fda orders shall relieve person liability federal state law indicates claims held lohr possibly mean claims since deprive mda clause content provides guidance claims contrary justice stevens contention post advance argument merely suggest one speculate upon congressional purposes best evidence found statute opinions joined five justices dispose riegels assertion lohr held duties general qualify duties respect device majority opinion lohr also disavowed conclusion stated believe mda statutory regulatory language necessarily precludes state requirements ever medtronic lohr footnotes verdicts juries obey rules however requirements kind juries apply rules make jury finding liability may induce defendant alter device label render finding requirement within meaning mda requirement rule law must obeyed event jury verdict merely motivates optional decision requirement bates dow agrosciences llc reason mda grant single state jury power whatsoever set standard either conforms differs relevant federal standard agree colorful inaccurate quotation page opinion see cipollone liggett group plurality opinion explaining fact scope limited positive enactments mean section claims proceeding analyze petitioner claims determine whether fact bates noting finding may rules well statutes regulations says nothing scope proceeding determine whether particular rules issue case satisfied conditions footnotes holding reach important issue outside bounds case preemptive effect evidence medical device defect comes light device receives premarket approval part lohr spoke part plurality unless otherwise indicated citations opinion refer portions lohr conveying opinion next provision allows political subdivisions apply exemption requirements medical devices set fda requirements stringent federal standards necessitated compelling local conditions prescription indicates solicitude state concerns embodied legislation regulation show congress homed state suits meant deny injured parties recourse introducing bill senate sponsor explained legislation written benefit doubt always given consumer consumer pays health life medical device malfunctions cong rec remarks kennedy see significant defects cardiac pacemakers necessitated voluntary recalls pacemakers involving units since injuries recorded resulted death example deaths injuries attributed heart valves deaths injuries heart pacemakers deaths injuries intrauterine devices cong rec remarks waxman fda search found deaths tied directly medical devices remarks nelson see also medtronic lohr dalkon shield ultimately linked thousands serious injuries otherwise healthy women vladeck preemption regulatory failure pepperdine rev october manufacturer settled litigated approximately dalkon shield cases sobol bending law story dalkon shield bankruptcy othing hearings committee reports debates lohr plurality noted suggest ed proponent legislation intended sweeping traditional remedies manufacturers distributors defective devices congress intended result failure even hint spectacularly odd particularly since members houses acutely aware ongoing product liability litigation see also adler mann preemption medical devices courts run amok mo rev extent congress mentioned common law tort claims criticize suggest needed barred federal regulation place rather note demonstrated additional protections consumers fda recently announced new position amicus brief see brief amicus curiae amicus brief interpreting statute entitled deference skidmore swift see mead weight accorded agency position skidmore depend upon thoroughness evident consideration validity reasoning consistency earlier later pronouncements factors give power persuade lacking power control see also mead courts consider inter alia consistency persuasiveness agency position good samaritan hospital shalala consistency agency position factor assessing weight position fda view limited preemptive effect better comports presumption preemption state health safety protections well purpose history mda fda new position entitled little weight regards unenlightening possibly mean claims provides guidance claims ante given presumption preemption operative even construing preemption clause see supra perceived lack guidance cut medtronic favor contrary bill need create federal claim damages witnesses testified right action exist ed hearings subcommittee senate committee commerce statement hines see also statement ladds act attempt modify restate common law respect personal defendants appears raised preemption defense state tort suits involving drugs see salmon parke davis north carolina law reyes wyeth texas law hoffman sterling drug pennsylvania law singer sterling drug indiana law mccue norwich pharmacal new hampshire law basko sterling drug connecticut law stromsodt north dakota law davis wyeth montana law roginsky new york law cunningham charles pfizer stevens parke davis cal bine sterling drug mo per curiam cases courts noted defendants interposed preemption plea defense unsuccessful see herman smith kline french supp ed see also infra decisions see leflar adler preemption pentad federal preemption products liability claims medtronic rev surely furor aroused suggestion medical devices receive exemption products liability litigation new drugs subject similar regulatory scrutiny agency remain standard tort law regime porter lohr decision fda perspective position food drug preemption fda regulation devices accorded entirely different weight private tort litigation counterpart regulation drugs biologics disparity neither justified appropriate agency believe intended congress drug amendments reiterated congress intent preempt claims relying state law nothing amendments shall construed invalidating provision state law valid absence amendments unless direct positive conflict amendments provision state law stat congress featured california regulatory system discussion also identified california system prime candidate exemption preemption equirements imposed california statute house report noted serve example requirements secretary authorize continued provided application submitted state meets requirements pursuant reported bill thus congress sought terminate state premarket approval systems rather place systems controlling authority fda process approving new drug begins preclinical laboratory animal testing sponsor new drug submits investigational new drug application seeking fda approval test drug humans see cfr et seq clinical trials generally proceed three phases involving successively larger groups patients subjects phase several hundred subjects phase ii several hundred several thousand subjects phase iii cfr completing clinical trials sponsor files new drug application containing inter alia full reports investigations showing whether drug safe use effective drug composition description drug manufacturing processing packaging proposed labeling drug see tobin astra pharmaceutical hill searle vioxx prods liability litigation supp ed la zyprexa prods liability litigation supp edny weiss fujisawa pharmaceutical supp ed perry novartis pharma supp ed mcnellis ex rel deangelis pfizer civ jbs wl nj jackson pfizer supp neb par pharmaceutical supp wd witczak pfizer supp zikis pfizer wl nd may cartwright pfizer supp ed tex eve sandoz pharmaceutical ip wl sd caraker sandoz pharmaceuticals supp sd motus pfizer supp cd cal kociemba searle supp see fed reg preamble labeling regulations discussing fda recently adopted view federal drug labeling requirements preempt conflicting state laws bextra celebrex marketing sales practices prod liability litigation crb wl nd colacicco apotex supp ed needleman pfizer civ wl nd dusek pfizer civ wl sd cf fed reg preamble proposed rule soon address issue levine wyeth wl cert granted question presented case whether prescription drug labeling judgments imposed manufacturers food drug administration pursuant fda comprehensive safety efficacy authority federal food drug cosmetic act et preempt state law product liability claims premised theory different labeling judgments necessary make drugs reasonably safe use pet cert wyeth levine