ÿWPCû ÄŒˆFœŒÂ{©í&ÙÊ߉Æzr†ƒ[NZxó ÐKZÓ:®œ QqÏ*ì!¾t‚„=ýÅ¡ô¶:^Ø£îsvÎÏ Rÿõœ7‚Yþ£ƒ"- &ãõ¹—ήIÍ2Êrpœ:™'-e8†{ùqç¶ò"G[òÌJ%e—w}îå**n¯]Ò'ôÒ O¿+B–î8®§Õ@ Ù¸úôÇܪІ¹£›œ°AÌJ¡œŠIÚÛ Uû©fEâ6‡°©i;í •°¨žé¢÷VBYYK»Ò8{pÍ8Pâ:ò„8YyÎç.C’ é|N,¦I@°5VµÇ!÷æÍµJLÿ{U÷’Ü@УÕÓÉc”mÒC[žÕÊ©Úzf! ‘Ëð±®ô,1šV&û“˜5ÆWRÜÔîÇ´ôðÛ€0%9!ò_HJmÂý S`›l ó>îô„§°1äû»VЧØPbÀ-\å²Å†K5ŽRä)ˆÚ›óQnB$Ø]TûäH¯`áqå7^©ß#&¤ylÉa ðÉëeùûçÏt…h ½ˆlÏóÑ6cªUä¸b %\U@b 0ˆ¢UN* 0Dx ¼!È zé Òc U:5 ^ o w{ 4 Æ“ ÆYÆÆåN«N­¯¾EÀ mÂ#ÁÙUNšššèèèèèèèèèèèèèèèèèèbðððððððððððððððððððððððððððððððððððð 0ëøøøø Bãã 0¤ D3¤ D-× 0K ASOÆ¢ 0¤h 0D  A«P»(ÈhH  Z(Times New Roman (`£ª$¡¡Ñ€.ÑÑ8€½­»»d»»d8ÑÑ ý ÑÓ  Ó(í€"  Z6Times New Roman Regular(#Ã$òòÚ  Ú0Ú  Úóó Ý ƒR‹l$ÝÓ  Óà  àòòÚ  Ú1Ú  ÚóóÔ€ô½ ò»»ÔÝ  ÝÔ_Ô€Ô‡ôŠ© ò òô½ÔThe€non„product€liability€claims€were€dismissed€by€the€trial€court€and€are€not€part€of€this€appeal.€ Ý ƒR‹l$ÝÓ  Óà  àòòÚ  Ú2Ú  ÚóóÔ€ô½ ò»»ÔÝ  ÝÔ_Ô€Ô‡ôŠ© ò òô½Ô€€€€Sofamor€Danek€Group,€Inc.€(now€Medtronic€Sofamor€Danek,€Inc.),€Danek€Medical,€Inc.,€and€WarsawÐ ° ÐOrthopaedic,€Inc.€were€party€defendants€in€the€Bish€lawsuit€but€have€been€voluntarily€dismissed€with€prejudice€and€nowÐ |Ì Ðare€parties€only€to€the€appeal€from€the€Haffey€suit.€Ô#†ô½ ò òôŠ©#ÔÔ‡ ôò òô½Ô ˜C:\PROGRA~1\COREL\WORDPE~1\TEMPLATE\CUSTOM~1\REVISE~1.WPTC:\Program Files\Corel\WordPerfect Office 2000\Template\Custom WP Templates\revised standard opinion.wpt,c½¬AZ‹"Arial Regularg“)â ¡B ) œ2ìk¡Level 1Level 2Level 3Level 4Level 5‚Level 1Level 2Level 3Level 4Level 5„Level 1Level 2Level 3Level 4Level 5…Level 1Level 2Level 3Level 4Level 53|xÿU‹ÿÀÀÀ˜HP LaserJet 8000 Series PSØÚØÚÚØØÚ0(ÆúI Z‹6Times New Roman Regular - ù-(|G2‹l$¤¤Ý ƒ£ª!ÝÑ€.ÑÑ8€ d»»d d 8ÑÑ ý ÑÓ  ÓÝ  Ýà  àòòÚ  Ú0Ú  ÚóóÔ€ôhxò»»Ô d(|3Åé$££Ý ƒ£ª!ÝÑ€.ÑÑ8€ d»»d d 8ÑÑ ý ÑÓ  ÓÝ  ÝVVVV'ÿÿdxd)!ÈÈÈÈdxdx( ±þ$’’ò òFigure€Ú  Ú1Ú  Úó ó^_X`YEþÿ<<CÿÿƒLevel 1Level 2Level 3Level 4Level 5(|3Åé$¢¢Ý ƒ£ª!ÝÑ€.ÑÑ8€ d»»d d 8ÑÑ ý ÑÓ  ÓÝ  Ý($$””ò òÚ  Ú1Ú  Úó óX[Z&OLE 2.0 Box <=8ÿÿÿÿÿÿÿÿÿÿCÿÿ HKKKKÝ ƒ£ª!ÝÑ€.ÑÑ8€¤»»d dÈ8ÑÑ ý ÑÓ  ÓÝ  ÝÔ_ÔÑ  ÑÔ€¼ê»»»ÔÑ8€nTXXdê»»d 8ÑÑ  Ñà@ü ü ìàÔ‡î {êÔIN€THE€COURT€OF€APPEALS€OF€TENNESSEEˆÐ ° Ðà@õõ%ìàAT€JACKSONÔ#†¼ê»îî { #ԈРÖ& ÐÓ  ÓApril€2000€SessionÐ üL ÐÔ‡X@æX»¼êÔÌò òÔ#†¼ê»XX@æí#ÔGRETCHEN€BISH,€òòet€al.óó€v.€SMITH€&€NEPHEW€RICHARDS,€INC.,€òòet€alóó.Ð úJ ÐEUGENE€HAFFEY,€Ô€X@æX»¼êÔó óET€AL.€Ô€¼ê»XX@æÔò òvó ó.€ò òSOFAMOR€DANEK€GROUP,€INC.,€ó óÔ‡X@æX»¼êÔET€ALò ò.Ô#†¼ê»XX@æ#ÔÐ  ^ ÐGRETCHEN€BISH,€ó óÔ‡X@æX»¼êÔET€ALÔ#†¼ê»XX@æ…#Ô,€Relating€to€Donald€Burton€ò òvó ó.€ò òSMITH€&€NEPHEW,Ð & v ÐÔ‡X@æX»¼êÔó óET€ALÔ#†¼ê»XX@æ#Ô.ò òó óÐ > Ž ÐÌà@@½½ìàò òAn€Interlocutory€Appeal€from€the€Circuit€Court€for€Shelby€CountyÐ b²  Ðà@@øøìàNos.€72995„1,€73049„1€€€€€€The€Honorable€John€R.€McCarroll,€Jr.,€JudgeÐ vÆ  ÐÌÌà@@ìì*ìàßA€V) °°` d€÷E<±` AßÐ ²  ÐÌà@@TTìàNo.€W1998„00373„Ô_ÔCOAÔ_Ô„R9„CV€„€Filed€August€23,€2000Ð Õ% ÐÌßA€V) °°` dE<ü` AßÐ ýM Ðó óÔ€X@æX»¼êÔÌÓ  Óà  àThese€are€consolidated€interlocutory€appeals€of€products€liability€suits€against€theÐ øH Ðmanufacturers€of€spinal€fixation€devices.€€The€trial€court€dismissed€plaintiffsðð€negligence€òòper€seóóÐ ä4 Ðclaims€based€on€the€alleged€violation€of€the€Food,€Drug€and€Cosmetics€Act€(FDCA)€and€the€MedicalÐ Ð  ÐDevice€Amendments€(MDA).€€In€one€of€the€cases,€the€trial€court€also€granted€defendantsðð€motion€òòinÐ ¼  Ðlimineóó€to€exclude€all€Federal€Drug€Administration€(FDA)€regulatory€evidence€information€andÐ ¨ø Ðdocuments€concerning€the€fixation€devices.€€Plaintiffs€appeal€the€rulings€of€the€trial€court.Ð ”ä ÐÓ³ÓÌò òTenn.R.App.P.€9;€Interlocutory€Appeal;€Judgment€of€the€Circuit€Court€Affirmed€andÐ l¼ ÐRemanded.ó óÐ X¨ ÐÌòòÓ  ÓW.€Frank€Crawford,€P.J.,€W.S.óó,€delivered€the€opinion€of€the€court,€in€which€òòAlan€E.€Highers,Ð 0 € ÐJ.óó€and€òòDavid€G.€Hayes,€J.óó,€joined.Ð !l ÐÌRoy€F.€Amedee,€Jr.,€LaPlace,€LA;€Lisa€June€Cox,€Jackson,€TN,€for€Appellants,€Haffey,€Bish€andÐ ô"D  ÐBurtonÐ à#0! ÐÌGlen€Reid,€Jr.,€Memphis,€TN;€James€B.€Irwin,€Nathan€T.€Gisclair,€Jr.,€Sally€I.€Gaden,€New€Orleans,Ð ¸%!# ÐLA,€for€Appellees,€Smith€&€Nephew,€Inc.Ð ¤&ô!$ ÐÌMurray€Levin,€Philadelphia,€PA;€George€Lehner,€Washington,€D.C.,€Sam€B.€Blair,€Jr.,€Memphis,Ð |(Ì#& ÐTN,€for€Appellees€Danek€Medical,€Inc.,€Warsaw€Orthopaedic,€Inc.€and€Sofamor€Danek€Group,€Inc.Ð h)¸$' ÐÓ) ÓÌò òÌÌÐ -h(+ý ЇOPINIONó óÐ ° ÐÌòòóóÓ  ÓÔ‡XnTXXX@æÔà  àThe€three€cases€before€the€court€on€interlocutory€appeal€were€consolidated€because€theyÐ ˆØ Ðinvolve€common€questions€of€law€and€fact.€€In€September€and€October,€1995,€complaints€were€filedÐ r Ðin€Shelby€County,€Tennessee€on€behalf€of€numerous€plaintiffs€who€allegedly€suffered€injuries€andÐ \¬ Ðdamages€as€a€result€of€the€implantation€of€internal€spinal€fixation€devices€utilizing€pedicle€screwsÐ F – Ðagainst€numerous€manufacturers€of€these€devices,€including€Sofamor€Danek€Group,€Inc.,€WarsawÐ 0 € ÐOrthopaedic,€Inc.,€Danek€Medical,€Inc.(hereinafter€collectively€referred€to€as€Danek),€and€Smith€&Ð  j ÐNEPHEW€Richards,€Inc.€€The€complaints€assert€multiple€causes€of€action€against€the€defendants,Ð  T Ðincluding€strict€liability,€negligence,€negligence€òòper€seóó,€breach€of€express€warranty,€breach€of€impliedÐ î >  Ðwarrant,€failure€to€warn,€unlawful€promotion,€negligent€misrepresentation,€civil€conspiracy,€concertÐ Ø (  Ðof€action,€and€negligent€infliction€of€emotional€distress.€€The€complaints€also€allege€that€the€devicesÐ Â  Ðinvolved€€had€not€received€the€required€FDA€clearance€and/or€approval€and€allege€fraud,€fraudulentÐ ¬ü  Ðmarketing€and€unlawful€promotion€against€the€named€defendants.׃×Ý ƒ#ÃÝòòÚ  Ú1Ú  ÚóóÝ  Ý×  ×Ð –æ  ÐÌà  àDue€to€the€number€of€plaintiffs,€a€Case€Management€Order€was€entered€by€the€trial€court.€Ð jº  ÐThis€Order€designated€fourteen€plaintiffs€for€trial,€and€the€plaintiffs€in€this€appeal€are€some€of€thoseÐ T¤ Ðdesignated.Ð >Ž ÐÌà  àOf€the€three€appeals€now€before€this€Court,€one€appeal€is€in€the€Haffey€suit,€originally€filedÐ b Ðin€the€Circuit€Court€of€Shelby€County€on€October€3,€1995€against€Danek.€€The€second€appeal€is€aÐ üL Ðseparate,€similar€complaint,€represented€by€plaintiff,€Gretchen€Bish,€filed€against€manufacturer,Ð æ6 ÐSmith€&€Nephew€Richards,€Inc.׃\×Ý ƒ#ÃÝòòÚ  Ú2Ú  ÚóóÝ  Ý×  ×€€The€third€appeal€is€in€a€case€represented€by€plaintiff€DonaldÐ Ð  ÐBurton,€and€presents€the€issue€of€the€admissibility€of€Federal€Drug€Administration€(ð ðFDAðð)€relatedÐ º  Ðevidence€during€the€trial€of€the€case€involving€only€Smith€&€Nephew€Richards,€Inc.€Ð ¤ô ÐÌà  àOn€November€12,€1997,€the€trial€court€granted€appelleesðð€motion€to€dismiss€the€plaintiffsððÐ xÈ Ðnegligence€òòper€seóó€claims,€holding:Ð b² ÐÌà8  àà8` Ð Ð à1.€No€private€right€of€action€exists€under€the€federal€Food,€Drug€&Ð 6† ÐCosmetic€Act€(FDCA),€and€to€allow€a€negligence€òòper€seóó€claim€basedÐ  p Ðupon€alleged€violations€of€it€would€be€inconsistent€with€the€FDCA;Ð !Z` x` x ЀÌà8  àà8` Ð Ð à2.€€The€federal€and€Tennessee€Statutes,€federal€FDA€Regulations,€andÐ Þ".! ÐFDCA€sections€referred€to€by€Plaintiffs€in€their€Complaints€andÐ È#" ÐMemoranda€are€not€suitable€as€negligence€òòper€seóó€standards€in€theseÐ ²$ # Ðpending€cases;М%ì $` x` x ÐÐ †&Ö!% Ðà8  àà8` Ð Ð à3.€€Even€if€the€federal€and€Tennessee€Statutes,€and€federal€FDAÐ ° ÐRegulations€and€FDCA€sections€referred€to€by€Plaintiffs€in€theÐ šê ÐComplaints€and€Memoranda€were€suitable€as€negligence€òòper€seóóÐ „Ô Ðstandards,€the€causal€connection€between€the€alleged€violations€of€theÐ n¾ Ðfederal€and€Tennessee€Statues,€federal€FDA€Regulations€and€FDCAÐ X¨ Ðand€Plaintiffsðð€alleged€injuries€is€too€tenuous€to€constitute€proximateÐ B ’ Ðcause.Ð, |` x` x ÐÌà8  àà8` Ð Ð à4.€€Plaintiffs€have€failed€to€state€a€negligence€òòper€seóó€claim€upon€whichÐ  P Ðrelief€can€be€granted.€€Ðê : ` x` x Ðà  àà ` àÌà8  àà8` Ð Ð àIT€IS€ORDERED,€ADJUDGED€AND€DECREED€that€DefendantsððÐ ¾  ÐMotions€to€Dismiss€Plaintiffsðð€Negligence€òòper€se€óóclaims€are€granted,Ð ¨ø  Ðand€Plaintiffsðð€negligenceòò€per€seóó€claims€are€dismissed€with€prejudice.Ð’â ` x` x ÐÌà  àOn€January€21,€1998,€the€trial€judge€ruled€in€open€court€that€the€FDA€regulatory€informationÐ f¶  Ðwould€not€be€proper€evidence€and€would€only€serve€to€confuse€the€jury.€€On€April€3,€1998,€the€trialÐ P  Ðcourt€entered€its€order€granting€defendantsðð€motion€òòin€limineóó€regarding€the€admissibility€of€allÐ :Š Ðregulatory€(FDA)€evidence€as€it€previously€ruled.€€The€Haffey€and€Bish€appellants€were€grantedÐ $t Ðinterlocutory€appeals.€€Subsequently,€after€a€mistrial,€the€Burton€appellant€was€granted€anÐ ^ Ðinterlocutory€appeal.€€The€three€appeals€were€consolidated.€€Ð øH ÐÌà  àThe€appellants€present€four€issues€for€review€as€stated€in€their€brief:Ð Ì ÐÌà8  àà8` Ð Ð à1.€€Whether€the€use€of€FDA€regulatory€information€or€regulations€asÐ  ð Ðevidence€is€proper?ЊÚ` x` x ÐÌà8  àà8` Ð Ð à2.€€Whether€use€of€FDA€regulatory€information€or€regulations€isÐ ^® Ðrelevant€to€issues€to€be€determined€at€trial?ÐH˜` x` x ÐÌ€€€à8  àà8` Ð Ð à3.€€Whether€admission€of€evidence€of€FDA€regulatory€information€orÐ  l Ðregulations€would€be€precluded€under€Section€403€of€the€TennesseeÐ !V ÐRules€of€Evidence€in€that€such€evidence€would€be€prejudicial,Ð ð!@  Ðconfusing€to€a€jury€or€a€waste€of€time?ÐÚ"*!` x` x ÐÌà8  àà8` Ð Ð à4.€€Whether€the€trial€court€erred€in€granting€Appelleesðð€Motion€toÐ ®$þ# ÐDismiss€Appellantsðð€Negligence€òòper€seóó€Claims?€Ð˜%è $` x` x ÐÌÓÓà  àWe€will€consider€the€fourth€issue€first.Ð l'¼"& ÐÓÓà  àThis€issue€is€controlled€by€our€Opinion€in€ò òòòKing€v.€Danek€Medical,€Inc.ó óóó,€No.€W1999„02651„Ð @)$( ÐCOA„R3„CV,€2000€WL€311143€(March€28,€2000,€Tenn.Ct.App.).€€In€ò òòòKingó óóó,€the€trial€court€dismissedÐ **z%) Ðprecisely€the€same€negligence€òòper€seóó€claims€made€by€the€plaintiffs€in€the€instant€case.€€In€affirmingÐ +d&* Ðthe€trial€court,€the€ò òòòKingó óóó€Court€stated:Ð þ+N'+ Їà8  àà8` Ð Ð àà ¸ àWhen€alleging€a€statute€or€regulation€based€on€a€negligenceÐ ° Ðòòper€seóó€claim,€it€is€not€sufficient€for€a€plaintiff€to€assume,€as€theseÐ šê Ðplaintiffs€have,€that€the€alleged€violation€of€a€statute€automaticallyÐ „Ô Ðsupports€a€claim€of€negligence€òòper€se.óó€€Even€if€the€plaintiffs€areÐ n¾ Ðwithin€the€class€to€be€protected€by€the€statute,€òòò òsee€€Hardenó óóó,€985Ð X¨ ÐS.W.2d€at€452,€a€statutory€negligence€òòper€seóó€claim€cannot€standÐ B ’ Ðunless€the€statute€establishes€a€standard€of€care.€€Talley€explains€theÐ , | Ðreason€for€this€rule:Ð f` x` x ÐÌà8  àà8` Ð Ð àà8¸ ` x` xàà  àWhere€a€statutory€provision€does€not€define€aÐ ê :  Ðstandard€of€care€but€merely€imposes€an€administrativeÐ Ô $  Ðrequirement,€such€as€the€requirement€to€obtain€aÐ ¾  Ðlicense€or€to€file€a€report€to€support€a€regulatoryÐ ¨ø  Ðscheme,€violation€of€such€requirement€will€notÐ ’â  Ðsupport€a€negligence€òòper€seóó€claim.€€Even€if€theÐ |Ì  Ðregulatory€scheme€as€a€whole€is€designed€to€protectÐ f¶  Ðthe€public€or€to€promote€safety,€the€licensing€dutyÐ P  Ðitself€is€not€a€standard€of€care,€but€an€administrativeÐ :Š Ðrequirement.€€òòò òSee€€Ridge€v.€Cessna€Aircraft€Co.ó óóó,€117Ð $t ÐF.3d€126,€131€(4th€Cir.1997)€(holding€that€federalÐ ^ Ðregulations€making€a€pilot€responsible€for€operation€ofÐ øH Ðhis€aircraft€and€requiring€him,€upon€request,€to€submitÐ â2 Ða€written€report€to€the€government€whenever€heÐ Ì Ðdeviates€from€an€aviation€rule€in€an€emergencyÐ ¶ Ðprovide€for€"general€standards€of€conduct,"€but€doÐ  ð Ð"not€impose€a€particular€duty,"€and€thus€their€violationÐ ŠÚ Ðwas€not€negligence€òòper€seóó€in€Virginia)[.]Ðtĸ ¸  ÐÌà8  àà8` Ð Ð àà ¸ à....ÐH˜` x` x Ðà8  àÐ Ð Ð  Ðà8  àà8` Ð Ð àà8¸ ` x` xàIn€concluding€that€the€FDCA€requirement€for€priorÐ  l Ðapproval€of€a€medical€device€does€not€itself€support€aÐ !V Ðclaim€for€negligence€òòper€seóó,€we€do€not€intend€toÐ ð!@  Ðtrivialize€the€alleged€violation€of€administrativeÐ Ú"*! Ðstatutory€provisions.€€They€are€essential€to€theÐ Ä#" Ðunderlying€federal€regulatory€scheme€that€servesÐ ®$þ# Ðimportant€societal€interests.€€But€because€such€specificÐ ˜%è $ Ðapproval€rules€are€administrative,€they€do€not€amountÐ ‚&Ò!% Ðto€a€legislative€judgment€as€to€the€standard€of€care,Ð l'¼"& Ðand€accordingly,€breach€of€these€provisions€inÐ V(¦#' Ðthemselves€cannot€underlie€a€negligence€òòper€seóó€claim.€Ð @)$( ÐÐ ¸ ¸  Ðà8  àà8` Ð Ð àà ¸ à179€F.3d€at€159.Ð+d&*` x` x ÐÐ þ+N'+ Ðà8  àà8` Ð Ð àà ¸ àWe€have€examined€the€statutes€cited€by€the€plaintiffs€as€theÐ ° Ðbasis€for€their€negligence€òòper€seóó€claim€and€agree€that€they€lackÐ šê Ðsufficient€substantive€content€to€support€such€a€claim.€€Accordingly,Ð „Ô Ðbased€upon€all€of€these€considerations,€we€conclude€that€the€plaintiffsÐ n¾ Ðcannot€bring€an€FDCA€based€negligence€òòper€seóó€claim.ÐX¨` x` x ÐÌà8  àà8` Ð Ð àà ¸ àThus,€as€to€the€plaintiffsðð€claims€of€negligence€òòper€seóó,€weÐ , | Ðconclude€that€they€can€prove€no€set€of€facts€which€would€entitle€themÐ  f Ðto€relief.€€Accordingly,€the€trial€court€was€correct€in€granting€theÐ  P Ðdefendantsðð€motion€to€dismiss€as€to€this€claim.Ðê : ` x` x Ðà  àÌòòò òKingó óóó,€at€*34.€€Ð ¾  ÐÌÓÓà  àIn€light€of€the€ruling€in€ò òòòKingó óóó,€we€find€this€issue€without€merit.Ð ’â  ÐÓÓà  àAppellantsðð€Issues€1€through€3€address€the€question€of€admissibility€into€evidence€of€FDAÐ f¶  Ðregulatory€information€and€regulations.€€The€initial€briefs€filed€in€the€case€for€the€most€part€referredÐ P  Ðto€the€ruling€of€the€court€that€generally€denied€the€introduction€of€FDA€regulatory€evidence€inÐ :Š Ðresponse€to€a€motion€òòin€limineóó€in€the€Burton€case.€€At€oral€argument,€reference€was€made€to€plaintiffÐ $t ÐBurtonððs€offer€of€proof,€and€the€court€requested€supplemental€briefs€from€the€parties€concerning€aÐ ^ Ðmore€precise€description€of€the€evidence€that€was€not€allowed.€€Burtonððs€supplemental€briefÐ øH Ðhighlights€the€offers€of€proof€of€Leslie€Sprinkle,€Jeff€Cobb,€and€Dr.€Carl€Larson.€€The€offers€of€proofÐ â2 Ðwere€quite€extensive€and€detailed,€and€we€will€attempt€to€briefly€summarize€the€key€elements€of€eachÐ Ì Ðwitnessððs€testimony.€€Ð ¶ ÐÌà  àLeslie€Marvin€Sprinkle€testified€that€he€is€vice„president€of€regulatory€and€clinical€affairs€Ð ŠÚ Ðand€quality€of€Smith€&€Nephew.€€His€testimony€primarily€focused€on€clinical€studies€of€orthopaedicÐ tÄ Ðimplants€in€humans.€€In€connection€with€FDA€regulations,€Sprinkle€defined€a€510€(k)€submissionÐ ^® Ðas€documents€that€are€provided€to€the€FDA€to€determine€whether€a€product€is€essentially€€equivalentÐ H˜ Ðto€a€product€that€was€in€interstate€commerce€prior€to€May€28,€1976.€€He€also€explained€that€Pre„Ð 2‚ ÐMarket€Approval€(PMA)€was€an€application€to€the€FDA€which€involves€clinical€trials€as€anÐ  l ÐInvestigation€of€Device€Exemption€(IDE).€€He€testified€that€between€1991€and€1993,€Smith€&Ð !V ÐNephew€had€no€510€(k)€clearing€the€Simmons€spinal€rating€system€for€the€posterior€or€pedicularÐ ð!@  Ðapplication.€€His€testimony€detailed€his€understanding€of€FDA€regulations€which€was€related€to€hisÐ Ú"*! Ðcompany€and€the€Simmons€rating€system.€€He€also€discussed€the€companyððs€actions€in€response€toÐ Ä#" ÐFDA€communication€and€explained€Smith€&€Nephewððs€decision„making€process€related€to€theÐ ®$þ# ÐSimmons€pedicle€screw€device.Ð ˜%è $ ÐÌà  àJeff€Cobb€testified€that€he€is€the€director€of€regulatory€affairs€for€Smith€&€Nephew.€€He€wasÐ l'¼"& Ðquestioned€concerning€the€510€(k)€submission€of€€a€clearance€letter€for€the€pedicle€screw€device€forÐ V(¦#' Ðonly€the€intended€use€of€anterior€lateral€fixation.€€He€testified€that€this€was€the€only€clearance€theyÐ @)$( Ðhad€until€1995,€but€that€Smith€&€Nephew€made€their€own€independent€determination€that€the€510Ð **z%) Ð(k)€submission€was€unnecessary€for€other€uses.€€He€was€also€questioned€concerning€communicationsÐ +d&* Ðfrom€the€FDA€concerning€IDE€and€proposed€deficiencies€in€the€IDE€application.€€He€testifiedÐ þ+N'+ Ðconcerning€the€companyððs€decision€to€terminate€the€IDE.€€He€was€also€questioned€concerningÐ ° Ðvarious€communications€from€the€FDA€and€identified€exhibits€dealing€with€FDA€communicationsÐ šê Ðconcerning€the€fixation€device.€€He€was€further€questioned€concerning€his€trip€report€for€a€seminarÐ „Ô Ðdiscussing€advertising,€labeling,€and€consumer€education,€and€testified€concerning€a€recall€of€aÐ n¾ Ðreported€defective€locking€nut.Ð X¨ ÐÌà  àDr.€Carl€Larson€testified€that€he€was€a€former€director€of€the€General€Restorative€DevicesÐ , | ÐDivision€of€the€FDA.€€Dr.€Larson€testified€in€depth€about€FDA€regulations€as€they€relate€to€medicalÐ  f Ðdevices€and€his€perception€of€a€manufacturerððs€duties€pursuant€to€the€law.€€He€testified€that€the€FDAÐ  P Ðidentified€certain€risks€with€regard€to€posterior€pedicle€screw€fixation.€€He€testified€that€anteriorÐ ê :  Ðlateral€fixation€was€not€subject€to€the€same€risks€as€the€pedicle€screw€fixations€and€that€neither€SmithÐ Ô $  Ð&€Nephew€nor€other€manufacturers€successfully€completed€IDE€and€generated€scientifically€reliableÐ ¾  Ðdata€to€establish€the€safety€of€any€pedicle€screw€device.€€Dr.€Larsonððs€testimony€extensivelyÐ ¨ø  Ðdiscussed€the€regulations€and€the€duties€of€the€manufacturer€with€regard€to€the€law.€€Ð ’â  ÐÌà  àThe€evidentiary€rules€pertinent€to€our€inquiry€are€Tenn.R.Evid.€401,€402,€and€403.€€TheyÐ f¶  Ðprovide:Ð P  ÐÌà8  àà8` Ð Ð àò òRule€401.€€Definition€of€ð ðrelevant€evidence.ðð€€ó ó„€ð ðRelevantÐ $t Ðevidenceðð€means€evidence€having€any€tendency€to€make€the€existenceÐ ` Ðof€any€fact€that€is€of€consequence€to€the€determination€of€the€actionÐ úJ Ðmore€probable€or€less€probable€than€it€would€be€without€the€evidence.Ðä4` x` x ÐÌà8  àà8` Ð Ð àò òRule€402.€€Relevant€evidence€generally€admissible;€irrelevantÐ ¸ Ðevidence€inadmissible.ó 󀄀All€relevant€evidence€is€admissible€exceptÐ ¢ò Ðas€provided€by€the€Constitution€of€the€United€States,€the€ConstitutionÐ ŽÞ Ðof€Tennessee,€these€rules,€or€other€rules€or€laws€of€general€applicableÐ xÈ Ðin€the€courts€of€Tennessee.€€Evidence€which€is€not€relevant€is€notÐ b² Ðadmissible.ÐLœ` x` x ÐÌò òà8  àà8` Ð Ð àRule€403ó ó.€€ò òExclusion€of€relevant€evidence€on€grounds€ofÐ  p Ðprejudice,€confusion,€or€waste€of€time.ó 󀀄€Although€relevant,Ð  !\ Ðevidence€may€be€excluded€if€its€probative€value€is€substantiallyÐ ø!H  Ðoutweighed€by€the€danger€of€unfair€prejudice,€confusion€of€the€issues,Ð â"2! Ðor€misleading€the€jury,€or€by€considerations€of€undue€delay,€waste€ofÐ Ì#" Ðtime,€or€needless€presentation€of€cumulative€evidence.ж$ #` x` x ÐÌò òó óà  àAll€of€plaintiffsðð€asserted€causes€of€action€comprise€a€product€liability€action€as€defined€inÐ Š&Ú!% ÐT.C.A.€Ô#†X@æXXXnTt #ÔÔ‡ XΰXXX@æÔððÔ#†X@æXX XΰàQ#ÔÔ‡XnTXXX@æÔ€29„28„102€(5)(1980).€€In€order€to€recover€in€such€an€action€against€a€manufacturer€or€sellerÐ t'Ä"& Ðof€a€product,€the€plaintiff€must€prove€that€the€product€was€ð ðin€a€defective€condition€or€unreasonablyÐ ^(®#' Ðdangerous€at€the€time€it€left€the€control€of€the€manufacturer€of€seller.ðð€€T.C.A.€Ô#†X@æXXXnT&R#ÔÔ‡ XΰXXX@æÔððÔ#†X@æXX Xΰ¬S#ÔÔ‡XnTXXX@æÔ€29„28„105€(1980).Ð H)˜$( ÐÌà  àRelevant€evidence€means€evidence€having€any€tendency€to€make€existence€of€any€fact€thatÐ +l&* Ðis€of€consequence€to€determination€of€the€action€more€probable€or€less€probable€than€it€would€beÐ ,V'+ Ðwithout€the€evidence.€€ò òòòGiven€v.€Lowó óóó,€661€S.W.2d€687€(Tenn.€Ct.€App.€1983).€€In€ò òòòOtis€v.€CambridgeÐ ° ÐMut.€Fire€Ins.€Co.ó óóó,€850€S.W.2d€439€(Tenn.€1992),€the€Court€said:Ð šê ÐÌà8  àà8` Ð Ð àà ¸ àIn€Tennessee€admissibility€of€evidence€is€within€the€soundÐ n¾ Ðdiscretion€of€the€trial€judge.€€When€arriving€at€a€determination€toÐ X¨ Ðadmit€or€exclude€even€that€evidence€which€is€considered€relevant€trialÐ B ’ Ðcourts€are€generally€accorded€a€wide€degree€of€latitude€and€will€onlyÐ , | Ðbe€overturned€on€appeal€where€there€is€a€showing€of€abuse€ofÐ  f Ðdiscretion.€€ò òòòStrickland€v.€City€of€Lawrenceburgóóó ó,€611€S.W.2d€832Ð  P Ð(Tenn.€Ct.€App.€1980);€Tennessee€Rules€of€Evidence€401;€ò òòòAustin€v.Ð ê :  ÐCity€Memphisóóó ó,€684€S.W.2d€624€(Tenn.€Ct.€App.€1984);€ò òòòInman€v.Ð Ô $  ÐAluminum€Co.€of€Americaó óóó,€697€S.W.2d€350€(Tenn.€Ct.€App.€1985).о ` x` x ÐÌà8  àà8` Ð Ð àà ¸ àWe€consider€the€rule€in€ò òòòMcCormack€v.€Riley,óóó ó€576€S.W.2dÐ ’â  Ð358,€360€(Tenn.€Ct.€App.€1978)€to€be€applicable€here:Ð|Ì ` x` x Ðà8  àà8` Ð Ð àÐ ` x` x Ðà8  àà8` Ð Ð àà8¸ ` x` xàNot€all€logically€relevant€evidence€is€admissible.€Ð P  ÐThus€evidence€which€would€advance€the€inquiry€butÐ :Š Ðwould€also€inflame€or€unduly€distract€the€jury€orÐ $t Ðrequire€an€undeserved€expenditure€of€judicial€time€orÐ ^ Ðunfairly€surprise€the€opponent€may€not€be€admissible.€Ð øH Ðò òòòSee€McCormick€on€Evidence€ó óóóðð€185€(2d€ed.€€1972).€Ð â2 ÐThe€probative€weight€of€evidence€must€be€balancedÐ Ì Ðagainst€those€attendant€costs€in€determining€thatÐ ¶ Ðevidence€should€be€admitted.Р𸠸  ÐÌà  àà ` àò òòòId.€óóó óat€360.Ð tÄ ÐÌ850€S.W.2d€at€442„443.Ð H˜ ÐÌà  àEvidence€upon€a€fact€not€in€issue€is€irrelevant€and€not€admissible€unless€collaterallyÐ  l Ðadmissible.€€ò òòòBridges€v.€CSX€Transp.,€Inc.,ó óóó€845€S.W.2d€760€(Tenn.€Ct.€App.€1992).€€In€ò òòòBridgesó óóó,€theÐ !V ÐCourt€noted:€ð ð[T]here€must€be€some€relevance€between€evidence€offered€and€the€issues€for€trial.€Ð ð!@  ÐSimply€because€evidence€may€bolster€a€plaintiffððs€case€does€not€make€it€irrelevant.ðð€€ò òòòId.ó óóó€at€764.Ð Ú"*! ÐÌà  àIn€the€instant€cases,€the€plaintiffs€are€required€to€prove€that€the€fixation€devices€wereÐ ®$þ# Ðdefective€or€unreasonably€dangerous€at€the€time€they€left€the€manufacturerððs€control.€€It€appears€from€Ð ˜%è $ Ðour€review€of€the€record€that€the€evidence€excluded€by€the€trial€court€and€offered€in€proof€does€notÐ ‚&Ò!% Ðtend€to€prove€the€determinative€issues€in€the€case€nor€lead€to€evidence€that€would€prove€such€issues.€Ð l'¼"& ÐThe€FDAððs€approval€or€nonapproval€of€the€devices€without€more€does€not€tend€to€prove€that€theÐ V(¦#' Ðdevices€were€defective€or€unreasonably€dangerous.€€Moreover,€a€review€of€the€testimony€of€the€threeÐ @)$( Ðwitnesses€offered€by€plaintiff€Burton€aptly€illustrates€the€reason€for€Tenn.R.Evid.€403.€€TheÐ **z%) Ðintroduction€of€the€proof€concerning€the€FDA€activity€in€regulation€would€result€in€a€confusion€ofÐ +d&* Ðthe€issues,€could€mislead€the€jury,€and€without€question€would€result€in€undue€delay€and€a€waste€ofÐ þ+N'+ Ðtime.€€Under€the€state€of€this€record,€if€there€is€any€probative€value€to€the€testimony,€it€is€substantiallyÐ ° Ðoutweighed€by€the€dangers€outlined€in€Rule€403.€€The€trial€court€did€not€abuse€its€discretion€inÐ šê Ðexcluding€the€proffered€evidence.Ð „Ô ÐÌà  àAccordingly,€the€orders€of€the€trial€court€are€affirmed.€€These€cases€are€remanded€to€the€trialÐ X¨ Ðcourt€for€such€further€proceedings€as€are€necessary.€€Costs€of€the€appeal€are€assessed€against€theÐ B ’ Ðappellants,€Eugene€Ô_ÔHaffeyÔ_Ô,€Ô_ÔGretchenÔ_Ô€Ô_ÔBishÔ_Ô,€and€Donald€Burton.Ô#†X@æXXXnTòS#ÔÐ , | ÐÌÌà  àà ` àà ¸ àà  àà h àà À à__________________________________________Ð î >  Ðà  àà ` àà ¸ àà  àà h àà À àW.€FRANK€CRAWFORD,€PRESIDING€JUDGE,€W.S.