ÿWPCŠu ²5ãŸë¼éô/Éå"bë脯#T {$DàÃD¹C>WZ‰×ªŽëÂ_fr¼FåqiãAVÝ.jÁü°{R3Ç¡i¾ßJõ6ÔÜj¢÷Nðë§TìN•â­LÀ…ñu~kÒÊÙ?„KÞ‰MŠÒp¥† Z«Ú†<ÆnÓbÖ— óˆªu&îß(Þi*§jŠè#=÷ÁkN¸Óç“û´{y*Æ©-Û/…†óî—DáäuöÕÅ L»Î!žiüw¦hHWbe<â!V;*d^P3b!i]J9t‰cÞéõß«Òi)ñv>«zïÙo…QÂJåX"߆ð^K ‰÷‘ø¸ 3í…¤Kÿ"ìc挧Œ(¼&ódÖ‰ÑÓmŠ“‡‚nøNŽ™ƒ!HíL®“eY›õ­¯‚›É>æ’¸¥8X‹Jîþ yÒ0áŠkw7y`Žs]E:-/RA×^—Qô-S7ñ×6÷èók›=š—ž½æ¢z˜‡»´+¥C™ßê2´IsÙ'7éÊ ì[nÃÆß$ÆîÈ”X¨šŠ‚às“11[vÍW ¯¥p–Jc ó¡çž%>Y3Ù ÛEPŒeÄP<º÷PNùú}/U®~s<l@és#ÁJ^ % 0ˆ U=N¥ wó 4÷ z Ò… W f mh 0.D ÆÃ Ɖ ÆOÆTÛN/^1âEqsÂssè5~Z›$ 0Nõ&ˆC'Ë+ â,Òì/b¾0ß 2Ýÿ4ûÜ7°×:×:µ‡;y<>µ@öÓAÀÉCʉDbSF[F>sI9±M¸êO©¢QºKSKSKSKS+T0V-2X¼_Y_Y¶ZºÑZ‹[l¡[ý ]¾ _ _ _ _ _GÈ_È_È_ËbôÚbÚbÂÎfÎf£gI3m3m 0.ë|n|n|n|n Bgogo 0¤„o D3(p D-[p 0Kˆpˆp ASÓpÆ&q 0¤ìq 0Dr A«ÔrÔrÔrÔrÔrÔrsssssssssss‚u˜HP LaserJet 4050 Series PCL 5eÈÈ,,,,ÈÈ0)L »(`£ª$¡¡Ñ€.ÑÑ8€½­»»d»»d8ÑÑ ý ÑÓ  Ó(í€"  Z6Times New Roman Regularö~ì(bk2èu§ ˜C:\PROGRA~1\COREL\WORDPE~1\TEMPLATE\CUSTOM~1\REVISE~1.WPTC:\Program Files\Corel\WordPerfect Office 2000\Template\Custom WP Templates\revised standard opinion.wpt3|xÿU‹ÿÀÀÀ(#Ã$òòÚ  Ú0Ú  ÚóóLevel 1Level 2Level 3Level 4Level 5‚Level 1Level 2Level 3Level 4Level 5„Level 1Level 2Level 3Level 4Level 5…Level 1Level 2Level 3Level 4Level 5 JÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú37Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔSpecifically,€the€trial€court€stated:€ð ðFirst€of€all€on€the€EKG,€I€think€thatððs€a€question€of€whether€Dr.€Miller€byÐ À Ðhis€own€decision€making€powers€should€have€given€an€EKG.€€I€think€its€also€a€question€to€discuss€whether€Tokos€shouldÐ „Ä Ðhave€talked€with€the€other€nurse€or€talked€with€Dr.€Miller.€€It€is€not,€again,€to€be€inferred€as€any€causation€for€anything,Ð Hˆ Ðbut€it€is€a€fact€that€happened.ðð TÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú2Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔCiba„Geigyððs€package€insert€and€the€parallel€PDR€reference€state€under€ð ðUsageðð€that€terbutaline€ð ðis€indicatedÐ À Ðfor€the€prevention€and€reversal€of€bronchospasm€in€patients€with€bronchial€asthma€and€reversible€bronchospasmÐ „Ä Ðassociated€with€bronchitis€and€emphysema.ðð€€Both€sources€expressly€warn€that,€ð ðTerbutaline€sulfate€should€not€be€usedÐ Hˆ Ðfor€tocolysis.€€Serious€adverse€reactions€may€occur€after€administration€of€terbutaline€sulfate€to€women€in€labor.€In€theÐ  L Ðmother,€these€include€increased€heart€rate,€transient€hyperglycemia,€hypokalemia,€cardiac€arrhythmias,€pulmonary€edema,Ð Ð Ðand€myocardial€ischemia.ðð ØÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú36Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔJudy€Elmore,€Tokosððs€vice€president€of€pharmacy,€undermined€the€latter€argument€when€she€testified€thatÐ À ÐTokos€employees€were€expected€to€adhere€to€the€companyððs€protocols€when€the€plan€was€to€stabilize€the€patient€and€thenÐ „Ä Ðsend€her€home€from€the€hospital€with€the€infusion€pump€in€place.€€There€is€no€factual€dispute€that€the€defendants€intendedÐ Hˆ Ðto€discharge€Ms.€Richardson€once€her€contractions€were€stopped€and€that€they€intended€for€her€to€maintain€her€pregnancyÐ  L Ðusing€the€infusion€pump€and€a€uterine€monitor.€€€ öÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú44Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔAlthough€Principal€Mutual€characterizes€its€claim€as€one€for€subrogation,€it€is€more€in€the€nature€of€a€claimÐ À Ðfor€reimbursement.€€The€policy€provision€on€which€Principal€Mutual€relies€allows€it€to€recoup€payments€made€to€its€ownÐ „Ä Ðinsured.€€òòSee€generallyóó€òòYork€v.€Sevier€County€Ambulance€Auth.óó,€8€S.W.3d€616,€619€(Tenn.€1999). ¸Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú43Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔDuring€his€cross„examination,€Tokosððs€lawyer€got€Dr.€Krone€to€admit€that€he€could€not€medically€rule€outÐ À Ðthe€possibility€that€Ms.€Richardson€could€have€had€the€heart€attack€due€merely€to€the€stress€of€pre„delivery€labor.€Ð „Ä ÐHowever,€Dr.€Krone€never€said€that€in€his€professional€opinion€the€heart€attack€òòwas€due€onlyóó€to€Ms.€Richardsonððs€labor.€Ð Hˆ ÐIn€any€event,€Dr.€Kroneððs€concession€on€cross„examination€went€to€the€weight€of€his€testimony,€which€was€for€the€juryÐ  L Ðto€determine. ÞÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú1Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€two€other€defendants€were€A+€Stat€Home€Care,€Inc.,€the€employer€of€the€home€health€nurse€whoÐ À Ðaccompanied€Christine€Evans€to€the€hospital€on€June€25,€1993,€and€the€Ciba„Geigy€Corporation,€the€manufacturer€ofÐ „Ä Ðterbutaline.€€These€defendants€were€later€dismissed€from€the€lawsuit€and€play€no€role€in€this€appeal. tÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú3Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€director€of€the€FDAððs€Center€for€Drug€Evaluation€and€Research€describes€off„label€use€as€€ð ð[u]se€forÐ À Ðindication,€dosage€form,€dose€regimen,€population€of€other€use€parameter€not€mentioned€in€the€approved€labeling.ðð€€òòSeeóóÐ „Ä ÐJanet€Woodcock,€òòA€Shift€in€the€Regulatory€Approachóó€(Presentation€to€DIA€Montreal€June€23,€1997)Ð Hˆ Ð()€(visited€July€5,€2000);€òòsee€also€Washington€LegalÐ  L ÐFound.€v.€Friedmanóó,€13€F.€Supp.€2d€51,€55€(D.D.C.€1998).€€As€a€general€matter,€off„label€usage€occurs€in€one€of€threeÐ Ð Ðcircumstances:€(1)€off„label€prescriptions€where€a€physician€orders€a€drug€or€device€to€be€used€in€any€manner€that€variesÐ ”Ô Ðfrom€the€labelððs€instructions;€(2)€off„label€promotion€or€marketing€where€a€manufacturer€promotes€a€drug€or€device€forÐ X˜ Ðpurposes,€to€patient€populations,€or€in€combinations€other€than€those€approved€by€the€FDA;€and€(3)€off„label€use€by€theÐ  \  Ðpatient€that€may€take€place€without€the€knowledge€of€the€manufacturer€or€prescribing€physician.€€òòSeeóó€Salbu,€51€Fla.€L.Ð À ÐRev.€at€188„92. PÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú4Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€infamous€ð ðElixir€Sulfanilamideðð€disaster€involved€the€deaths€of€over€one€hundred€Tennesseans€who€wereÐ À Ðpoisoned€after€a€reckless€manufacturer€marketed€a€supposedly€therapeutic€potion€containing€the€solvent€diethylene€glycol.€Ð „Ä ÐòòSeeóó€David€F.€Cavers,€òòThe€Food,€Drug,€and€Cosmetics€Act€of€1938:€Its€Legislative€History€and€Its€Substantive€Provisionsóó,Ð Hˆ Ð6€Law€&€Contemp.€Probs.€2,€20€(1939).€€(ÍO$——ÔÿÔòòóóÔÿÔ ~Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú39Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€status€of€Exhibit€3€is€somewhat€unclear.€€Even€though€the€trial€court€directed€unequivocally€that€PBH„Ð À Ð00304€containing€the€language€ð ðIt€is€strongly€recommended€that€patients€have€a€recent€EKG€.€.€.ðð€be€admitted€as€ExhibitÐ „Ä Ð3,€the€copy€of€Exhibit€3€containing€this€language€is€actually€marked€ð ðID€only.ðð€€In€addition,€the€appellate€record€containsÐ Hˆ ÐExhibit€3A€which€is€also€a€copy€of€PBH„00304€but€from€which€the€strong€recommendation€for€an€EKG€has€obviouslyÐ  L Ðbeen€whited€out.€€Other€than€the€exhibit€stamp€itself,€the€transcript€contains€no€indication€that€Exhibit€3A€was€everÐ Ð Ðadmitted€into€evidence.€€Having€no€explanation€concerning€how€Exhibit€3A€came€to€be€admitted,€we€will€base€ourÐ ”Ô Ðdecision€on€Exhibit€3€because€the€transcript€clearly€indicates€that€the€trial€court€permitted€Ms.€Palmer€to€testify€regardingÐ X˜ Ðthe€very€language€that€was€whited€out€on€Exhibit€3A.€€ Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú45Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔOf€course,€any€question€about€whether€Ms.€Richardson€has€been€made€whole€in€this€case€remains€to€beÐ À Ðlitigated€on€remand.€€ Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú5Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_Ôð ðLabelingðð€is€a€term€of€art€that€encompasses€all€written,€printed,€or€graphic€material€on€any€of€the€drugððsÐ À Ðcontainers€or€wrappers€accompanying€the€drug.€€òòSeeóó€21€U.S.C.A.€ðð€321(k)€&€(m)€(West€1999);€òòWashington€Legal€Found.Ð „Ä Ðv.€Friedmanóó,€13€F.€Supp.€2d€at€55.€€It€also€includes€any€other€form€of€a€drug€companyððs€promotional€activities,€includingÐ Hˆ Ðbooklets,€pamphlets,€mailing€pieces,€bulletins,€and€all€other€literature€that€supplements,€explains,€or€is€otherwise€relatedÐ  L Ðto€the€drug.€€òòSeeóó€21€C.F.R.€ðð€202.1(l)(1),€(2)€(1999).€€ ÈÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú7Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔDr.€Nightengale€is€the€FDAððs€Associate€Commissioner€for€Health€Affairs. XÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú8Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSee€United€States€v.€Algon€Chem.,€Inc.óó,€879€F.2d€1154,€1163€(3d€Cir.€1989);€òòChaney€v.€Heckleróó,€718€F.2dÐ À Ð1174,€1180€(D.C.€Cir.€1983),€òòrevððd€on€other€groundsóó,€470€U.S.€821€(1985). ÕÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú9Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔSimilarly,€the€off„label€use€of€a€drug€or€device€by€a€physician€seeking€an€optimal€treatment€for€his€or€her€patientÐ À Ðis€not€necessarily€considered€to€be€research€or€an€investigational€or€experimental€treatment€when€the€use€is€customarilyÐ „Ä Ðfollowed€by€physicians.€€òòSee€Weaver€v.€Reagenóó,€886€F.2d€194,€198„99€(8th€Cir.€1989);€òòSalgo€v.€Leland€Stanford,€Jr.Ð Hˆ ÐUniv.€Bd.€of€Trusteesóó,€317€P.2d€170,€180€(Cal.€Ct.€App.€1957);€òòRamon€v.€Farróó,€770€P.2d€131,€135€(Utah€1989);€BeckÐ  L Ð&€Azari,€53€Food€&€Drug€L.J.€at€83. ÓÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú10Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔEven€though€this€position€is€found€in€a€rule€that€was€never€made€final,€the€FDA€recently€restated€it.€€òòSeeóóÐ À ÐCitizen€Petition€Regarding€the€FDAððs€Policy€on€Promotion€of€Unapproved€Uses€of€Approved€Drugs€and€Devices:Ð „Ä ÐRequest€for€Comments,€59€Fed.€Reg.€59,820,€59,821€(Nov.€18,€1994).€€This€position€remains€an€ð ðimportant€statementÐ Hˆ Ðof€agency€policy.ðð€€David€G.€Adams,€òòThe€Food€and€Drug€Administrationððs€Regulation€of€Health€Care€ProfessionalsóóÐ  L Ð423,€426€(David€G.€Adams,€et€al.,€eds.,€2d€ed.€1997). ñÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú11Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔBecause€the€pace€of€medical€discovery€runs€ahead€of€the€FDAððs€regulatory€machinery,€the€off„label€use€ofÐ À Ðsome€drugs€is€frequently€considered€to€be€ð ðstate„of„the„artðð€treatment.€€òòSeeóó€Beck€and€Azari,€53€Food€&€Drug€L.J.€at€79.€Ð „Ä ÐIn€some€circumstances,€an€off„label€use€of€a€particular€drug€or€device€may€even€define€the€standard€of€care.€€òòSee€HartwellÐ Hˆ Ðv.€Danek€Med.,€Inc.óó,€47€F.€Supp.€2d€703,€705€n.3€(W.D.€Va.€1999);€òòWashington€Legal€Found.€v.€Friedmanóó,€13€F.€Supp.Ð  L Ð2d€at€56;€òòProctor€v.€Davisóó,€682€N.E.2d€at€1210.€€ ¦Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú6Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThis€proposed€rule€was€never€made€final. «Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú12Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€Government€Accounting€Office€has€estimated€that€25%€of€all€anti„cancer€drugs€are€prescribed€off„labelÐ À Ðand€that€56%€of€all€cancer€patients€receive€at€least€one€drug€off„label.€€òòSeeóó€GAO€Report,€at€5,€11,€13„14,€40;€òòsee€alsoóóÐ „Ä ÐTenn.€Code€Ann.€ðð€56„7„2352(a)(6)€(Supp.€1999)€(reflecting€the€Tennessee€General€Assemblyððs€finding€thatÐ Hˆ Ðapproximately€fifty€percent€of€all€cancer€drug€treatment€is€for€off„label€indications);€Smith,€34€Wake€Forest€L.€Rev.€atÐ  L Ð971.€€ oÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú13Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€Robert€Levine,€òòEthics€and€Regulation€of€Clinical€Researchóó,€241€(2d€ed.€1986);€Beck€&€Azari,€53€FoodÐ À Ð&€Drug€L.J.€at€79„80;€J.S.€Jameson€&€M.E.€Holland,€òòOff„Label€Use€of€Antimicrobial€Agents€in€Infants,€Children€andÐ „Ä ÐAdolescents:€A€Time€for€Actionóó,€17€Pediatric€Infectious€Disease€J.€739,€744€(1998);€Smith,€34€Wake€Forest€L.€Rev.€atÐ Hˆ Ð971;€143€Cong.€Rec.€S8165€(daily€ed.€July€28,€1997)€(statement€of€Sen.€Bill€Frist). Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú14Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€Gregory€Mundy,€et€al.,€òòCurrent€Medical€Practice€and€the€Food€and€Drug€Administrationóó,€229€JAMAÐ À Ð1744,€1746€(1974). ìÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú15Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔForty€percent€of€all€drugs€prescribed€for€AIDS€treatment€are€off„label€and€eighty€percent€of€AIDS€patientsÐ À Ðreceive€at€least€one€off„label€prescription.€€òòSeeóó€Carole€Brosgart,€òòOff„Label€Use€in€Human€Immunodeficiency€VirusÐ „Ä ÐDiseaseóó,€12€J.€Acquired€Immune€Deficiency€Syndromes€and€Human€Retrovirology€56,€57„58€(1996). ¶Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú16Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€Beck€&€Azari,€53€Food€&€Drug€L.J.€at€80€n.17. ÀÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú19Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSee€Haught€v.€Macelichóó,€681€F.2d€291,€303€n.12€(5th€Cir.€1982);€òòOhligschlager€v.€Proctor€Community€Hosp.óó,Ð À Ð303€N.E.2d€392,€396€(Ill.€1973);òò€Mulder€v.€Parke€Davis€&€Co.óó,€181€N.W.2d€882,€887€(Minn.€1970);€òòMueller€v.€Muelleróó,Ð „Ä Ð221€N.W.2d€39,€42„43€(S.D.€1974).€€- ù- Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú20Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSee€Salgo€v.€Leland€Stanford,€Jr.€Univ.€Bd.€of€Trusteesóó,€317€P.2d€at€180;€òòBowman€v.€Songeróó,€820€P.2d€1110,Ð À Ð1114€(Colo.€1991);€òòGarvey€v.€OððDonoghueóó,€530€A.2d€1141,€1145„46€(D.C.€App.€1987);€òòCraft€v.€Peeblesóó,€893€P.2d€138,Ð „Ä Ð151€(Haw.€1995);€òòThompson€v.€Carteróó,€518€So.€2d€609,€613€(Miss.€1987);€òòBissett€v.€Rennaóó,€710€A.2d€404,€408€(N.H.Ð Hˆ Ð1998);€òòMorlino€v.€Medical€Ctr.óó,€706€A.2d€at€728;€òòSpensieri€v.€Laskyóó,€723€N.E.2d€at€548;€òòGrayson€v.€Stateóó,€838€P.2d€546,Ð  L Ð549€(Okla.€Ct.€App.€1992);€òòRamon€v.€Farróó,€770€P.2d€at€135. 4Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú21Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔFollowing€these€changes,€the€labeling€provided€the€following€warning€for€the€intavenous€use€of€Brethine:Ð À ÐÌà8  àControlled€clinical€studies€and€other€clinical€experience€have€shown€that€Brethine,€like€other€ðð„Ð Hˆ Ðadrenergic€agonists,€can€produce€a€significant€cardiovascular€effect€in€some€patients,€as€measured€byÐ  L Ðpulse€rate,€blood€pressure,€symptoms,€and/or€ECG€changes.ÐÐÐ Ð  ÐÌThe€following€also€appeared€in€the€ð ðprecautionsðð€section€of€the€labeling:Ð X˜ ÐÌà8  àTerbutaline€sulfate€should€not€be€used€for€tocolysis.€€Serious€adverse€reactions€may€occur€afterÐ à  Ðadministration€of€terbutaline€sulfate€to€women€in€labor.€€In€the€mother,€these€include€increased€heartÐ ¤ ä  Ðrate,€transient€hyperglycemia,€hypokalemia,€cardiac€arrhythmias,€pulmonary€edema,€and€myocardialÐ h ¨  Ðischemia. /Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú17Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€publisher€of€the€PDR€now€publishes€the€ð ðPDR€Companion€Guide,ðð€an€1,800„page€reference€augmentingÐ À Ðthe€PDR.€€This€guide€includes€an€ð ðOff„Label€Treatment€Guideðð€listing€drugs€routinely€used,€but€never€approved,€for€theÐ „Ä Ðtreatment€of€nearly€one€thousand€disorders.€€òòSeeóó€Medical€Economics€Co.,€òòPhysiciansðð€Desk€Referenceóó,€Foreword€(54thÐ Hˆ Ðed.€2000). ®Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú23Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔLetter€from€Janet€Woodcock,€Director,€Center€for€Drug€Evaluation€and€Research,€to€Fung€Lam,€M.D.,Ð À ÐTerbutaline€Strategy€Group,€at€p.€3€(Oct.€19,€1999)€()Ð „Ä Ð(visited€July€6,€2000)€(ð ðWoodcock€Letterðð). ŸÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú24Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔFor€the€purposes€of€the€bulletin,€ACOG€defined€ð ðpreterm€laborðð€as€ð ðlabor€occurring€prior€to€the€completionÐ À Ðof€37€weeks€of€gestation€(less€than€259€days€from€the€last€menstrual€period).ðð€€ACOG€Bulletin€No.€206,€òòsupraóó€note€22,Ð „Ä Ðat€1. °Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú25Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔACOG€Bulletin€No.€206,€òòsupraóó€note€22,€at€6. !Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú31Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€most€recent,€well„publicized€example€of€the€harmful€effects€of€using€prescription€drugs€off„label€is€Fen„Ð À ÐPhen.€€After€the€off„label€use€of€these€two€drugs€for€weight€management€became€widespread,€it€was€discovered€that€theÐ „Ä Ðdrugs€were€causing€cardiac€valvular€damage.€€Accordingly,€the€use€of€these€once€popular€drugs€for€weight€control€wasÐ Hˆ Ðdiscontinued. øÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú18Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔThe€Tennessee€Supreme€Court€recently€recognized€a€narrow€exception€to€this€principle€when€it€held€that€aÐ À Ðjury€could€infer€negligence€from€an€unsuccessful€result€if€an€expert€testifies€that€the€result€would€not€ordinarily€haveÐ „Ä Ðoccurred€in€the€absence€of€negligence.€€òòSee€Seavers€v.€Methodist€Med.€Ctr.óó,€9€S.W.3d€86,€96€(Tenn.€1999). #Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú22Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔAmerican€College€of€Obstetricians€and€Gynecologists,€Technical€Bulletin€No.€206,€òòPreterm€Laboróó€6€(JuneÐ À Ð1995)€(ð ðACOG€Bulletin€No.€206"). ²Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú26Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔACOG€Bulletin€No.€206,€òòsupraóó€note€22,€at€6.€€ ¬Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú27Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔACOG€Bulletin€No.€206,€supra€note€22,€at€4.€€ °Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú28Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔACOG€Bulletin€No.€206,€òòsupraóó€note€22,€at€8. Ñ À Ñ bÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú30Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔSee€Letter€from€Stuart€L.€Nightengale,€Associate€Commissioner€for€Health€Affairs,€(visited€July€6,€2000)Ð À Ð(Nov.€13,€1997)€€(ð ðDear€Colleague€Letterðð). óÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú32Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔWe€note€the€existence€of€two€reported€cases€in€which€the€patients€alleged€that€their€physician€was€negligentÐ À Ðfor€failing€to€use€terbutaline€for€tocolysis.€€òòSee€Bell€v.€Maricopa€Med.€Ctr.óó,€755€P.2d€1180,€1182€(Ariz.€Ct.€App.€1988);Ð „Ä ÐòòBridges€v.€Shelby€Womenððs€Clinic,€P.A.óó,€323€S.E.2d€372,€374„76€(N.C.€Ct.€App.€1984).€€ ´Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú29Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€Woodcock€Letter,€òòsupraóó€note€23,€at€6. =Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú33Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔIf,€for€example,€he€asserted€that€using€the€infusion€pump€to€administer€terbutaline€posed€less€of€a€danger€toÐ À ÐMs.€Richardson€because€lower€doses€were€being€administered,€he€would€have€been€required€to€explain€away€the€fact€thatÐ „Ä Ðusing€the€infusion€pump€results€in€the€same€or€higher€levels€of€terbutaline€in€the€patientððs€system.€€òòSeeóó€Woodcock€Letter,Ð Hˆ Ðòòsupraóó€note€23,€at€6. ÁÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú35Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€òòWhite€v.€Vanderbilt€Univ.óó,€1999€WL€1270974,€at€*8. êÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú40Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔChristine€Evans,€the€registered€nurse€employed€by€Tokos€who€assessed€Ms.€Richardsonððs€suitability€for€anÐ À Ðinfusion€pump,€testified€regarding€the€patient€selection€criteria€in€Tokosððs€ð ðHospital€Protocol.ðð€€She€also€testified€thatÐ „Ä Ðshe€decided€that€an€EKG€was€not€warranted€based€on€the€information€she€obtained€from€Ms.€Richardson€and€her€chart.€Ð Hˆ ÐGail€Garner,€the€Tokos€area€clinical€pharmacist€who€consulted€with€Ms.€McBride€regarding€the€proper€dosage€level€forÐ  L ÐMs.€Richardson,€testified€that€Dr.€Miller€was€responsible€for€determining€whether€tocolytic€therapy€was€appropriate.€Ð Ð ÐLater,€Judy€Elmore€testified€regarding€PBH„00301,€Tokosððs€policy€containing€the€guidelines€for€accepting€patients€forÐ ”Ô Ðsubcutaneous€tocolytic€infusion€therapy.€€€ ¸Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú38Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔPBH„00322€was€never€made€part€of€the€record€in€this€case. ™Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú42Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔMs.€Richardsonððs€lawyer€argued€the€following€to€the€jury€without€objection:€€Ð À ÐÌà8  àà ` àIððm€not€a€conspiracy€type€person€that€believes€the€President€Kennedy€conspiracy€and€all,€IÐ Hˆ Ðreally€am€not€that€kind€of€person.€€And€there€may€not€be€ð!ð€thereððs€probably€no€conspiracy,€but€thereððsÐ  L Ðsomething€strange€about€these€medical€records€missing.€€That€is€just€too€coincidental.€€It€really€is.ÐÐÐ Ð  Ðà8  àà ` àIððm€not€accusing€anyone€of€potentially€doing€this,€but€the€fact€of€the€matter€is€the€nursingÐ ”Ô Ðassessment€thatððs€an€exhibit€in€this€case,€Exhibit€Number€6,€was€not€filled€out€by€Chris€Evans.€€ItððsÐ X˜ Ðundated.€€She€testified€that€the€nursing€assessment€that€she€filled€out€she€mailed€it€in€and€itððs€missing.€Ð  \ ÐItððs€something€to€look€at.Ðà Ð Ð  Ðà8  àà ` àI€submit€it€just€goes€along€with€the€attitude€of€this€company€thatððs€been€throughout€this€wholeÐ ¤ ä  Ðtrial.€€I€wonder€what€the€nursing€assessment€that€she€filled€out€said.€€Iððd€like€to€see€that.€€I€wonder€whatÐ h ¨  Ðit€said.€€Not€approved€for€treatment?€€Who€knows.€€Itððs€not€here. ?Ý ƒRý¡$ÝÓ  Óà  àòòÚ  Ú34Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔòòSeeóó€òòWhite€v.€Vanderbilt€Univ.óó,€No.€M1997„00105„COA„R3„CV,€1999€WL€1270974,€at€*€8€(Tenn.€Ct.€App.Ð À ÐDec.€30,€1999),€òòperm.€app.€deniedóó€(Tenn.€June€5,€2000).€(|G2ý¡$¤¤Ý ƒ£ª!ÝÑ€.ÑÑ8€TÅ»»dd8ÑÑ ý ÑÓ  ÓÝ  Ýà  àòòÚ  Ú0Ú  ÚóóÔ€ôð ò»»Ô d(|3Ç$££Ý ƒ£ª!ÝÑ€.ÑÑ8€TÅ»»dd8ÑÑ ý ÑÓ  ÓÝ  ÝVVVV'ÿÿdxd)!ÈÈÈÈdxdx( ±þ$’’ò òFigure€Ú  Ú1Ú  Úó ó^_X`YEþÿ<<CÿÿƒLevel 1Level 2Level 3Level 4Level 5(|3Ç$¢¢Ý ƒ£ª!ÝÑ€.ÑÑ8€TÅ»»dd8ÑÑ ý ÑÓ  ÓÝ  Ý($$””ò òÚ  Ú1Ú  Úó óX[Z&OLE 2.0 Box <=8ÿÿÿÿÿÿÿÿÿÿCÿÿ HKKKK ùÝ ƒRý¡$ÝÓ  Óà  àòòÚ  Ú41Ú  ÚóóÔ€ôð ò»»ÔÝ  ÝÔ_ÔTokosððs€registered€nurse€was€accompanied€by€a€home€health€nurse€employed€by€A+€Stat€€Home€Care.€Ð À ÐPresumably,€Ms.€Richardsonððs€care€at€home,€had€she€been€discharged,€would€have€been€provided€through€A+€Stat€HomeÐ „Ä ÐCare.€€No€issue€has€been€raised€in€this€record€regarding€the€credentialing€of€the€home€health€nurse€or€A+€Stat€Home€Care. Ý ƒ£ª!ÝÑ€.ÑÑ8€TÅ»»ddÈ8ÑÑ ý ÑÓ  ÓÝ  ÝÔ_ÔÑÀ°ÑÑH°ÑÔ€¼TÅ»»»ÔÑ8€ÙXXdì»»d8ÑÑ  ÑÑ  ÑÑ€??cÑà@ü ü ìàÔ‡îV´î»¼TÅÔIN€THE€COURT€OF€APPEALS€OF€TENNESSEEÔ#†¼TÅ»îîV´9#ԈРÀ Ðà@kk$ìàÔ‡îV´î»¼TÅÔAT€NASHVILLEÔ#†¼TÅ»îîV´Ç#ԈРæ& Ðà@,,!ìàMarch€1998€SessionˆÐ  L ÐÔ‡XÙX»¼TÅÔÌò òÔ#†¼TÅ»XXÙe#ÔÓ  ÓCYNTHIA€RICHARDSON,€òòet€al.óó€v.€JAMES€MILLER,€M.D.,€òòet€alóó.ó óÐ  J ÐÓ«ÓÌÔ€XÙX»¼TÅÔà@6 6 ìàò òAppeal€from€the€Circuit€Court€for€Davidson€CountyˆÐ 0 p Ðà@„ „ ìàNo.€94C„1993€€€€€€Marietta€M.€Shipley,€JudgeˆÐ  \ ÐÌà@ìì*ìàßA€V) °°` d€÷E<ó ` A߈Ð ô 4  ÐÌà@Ç Ç ìàNo.€M1997„00205„Ô_ÔCOAÔ_Ô„R3„CV€„€Filed€August€16,€Ô_Ô2000Ô_ԈРï /  ÐÌßA€V) °°` dE<Æ` AßÐ Ç  Ðó óÌThis€appeal€involves€a€medical€malpractice€action€stemming€from€the€use€of€an€infusion€pump€toÐ Â  Ðadminister€terbutaline€sulphate€subcutaneously€to€arrest€a€pregnant€womanððs€labor.€€After€sufferingÐ ®î  Ða€heart€attack€shortly€before€giving€birth€to€a€healthy€child,€the€woman€and€her€husband€filed€suit€inÐ šÚ Ðthe€Circuit€Court€for€Davidson€County€against€her€attending€physician,€the€supplier€of€the€infusionÐ †Æ Ðpump,€and€others€alleging€that€their€negligence€had€caused€her€heart€attack.€€The€womanððs€medicalÐ r² Ðinsurance€carrier€intervened€to€assert€its€contractual€reimbursement€rights€based€on€the€payments€itÐ ^ž Ðhad€advanced€for€the€womanððs€medical€expenses.€€The€trial€court€dismissed€the€insurance€carrierððsÐ JŠ Ðcomplaint,€and€a€jury€returned€a€verdict€for€the€physician€and€the€pump€supplier.€€Among€their€issuesÐ 6v Ðon€this€appeal,€the€woman€and€her€husband€take€issue€with€the€exclusion€of€evidence€regarding€theÐ "b ÐFDA„approved€uses€of€terbutaline€and€with€the€trial€courtððs€refusal€to€give€their€requested€missingÐ N Ðevidence€instruction.€€The€physician€and€the€pump€supplier€assert€that€they€were€entitled€to€a€directedÐ ú: Ðverdict€at€the€close€of€all€the€proof.€€Finally,€the€medical€insurance€carrier€takes€issue€with€theÐ æ& Ðdismissal€of€its€reimbursement€claim.€While€we€have€determined€that€the€trial€court€correctlyÐ Ò Ðoverruled€the€motions€for€directed€verdict,€we€conclude€that€the€trial€court€erred€by€excluding€theÐ ¾þ Ðevidence€regarding€the€off„label€use€of€terbutaline€and€by€declining€to€give€the€requested€instruction.€Ð ªê ÐThe€trial€court€also€erred€by€dismissing€the€medical€insurance€carrierððs€claim.€€Accordingly,€weÐ –Ö Ðvacate€the€judgment€for€the€physician€and€manufacturer€of€the€pump€and€remand€the€case€for€a€newÐ ‚ Ðtrial.Ð n ®  ÐÌò òà@  ìàTenn.€R.€App.€P.€3€Appeal€as€of€Right;€Judgment€of€the€Circuit€Court€Vacated€and€ó óˆÐ F"†" Ðà@  &ìàò òRemandedó óˆÐ 2#r# ÐÌòòWilliam€C.€Koch,€Jr.,€L.,óó€òòóódelivered€the€opinion€of€the€court,€in€which€òòHenry€F.€Todd,€P.J.,€M.S.óó,Ð  %J!% Ðjoined.€€òòBen€H.€Cantrell,€J.óó,€filed€a€dissenting€opinion.Ð ö%6"& ÐÌMary€A.€Parker€and€C.€Michael€Lawson,€Nashville,€Tennessee,€for€the€appellants,€CynthiaÐ Î'$( ÐRichardson€and€William€Richardson.Ð º(ú$) ÐÌDouglas€Berry,€Nashville,€Tennessee,€for€the€appellant,€Principal€Mutual€Life€Insurance€Company.Ð ’*Ò&+ ÐÌThomas€A.€Wiseman,€III,€Nashville,€Tennessee,€for€the€appellee,€James€Miller,€M.D.Ð j,ª(- ÐÌThomas€Pinckney,€Nashville,€Tennessee,€for€the€appellee,€Tokos€Medical€Corporation.Ð B.‚*/ ÐÐ ./n+0ý' ÐÑ??cÑâ ?âÑÀHÑâ ?âÑ  Ñà@66'ìàò òOPINIONó óˆÐ À ÐÌà  àCynthia€Richardson€married€William€Richardson€in€1991.€€Ms.€Richardson€was€a€26„year„oldÐ ˜Ø Ðphysical€therapist,€and€Mr.€Richardson€was€four€years€her€junior.€€Ms.€Richardson€loved€children,Ð „Ä Ðand€the€couple€decided€not€to€delay€starting€a€family€because€Ms.€Richardson,€as€she€put€it€later,€feltÐ p° Ðher€ð ðbiological€clock€ticking.ðð€€Ms.€Richardson€learned€that€she€was€pregnant€with€the€coupleððs€firstÐ \œ Ðchild€on€Thanksgiving€Day€1992.€€Her€estimated€due€date€was€July€28,€1993.Ð H ˆ ÐÌà  àMs.€Richardson€sought€her€prenatal€care€from€Dr.€James€Miller.€€In€early€January€1993,€Ms.Ð  ` ÐRichardson€complained€that€she€was€experiencing€periods€of€palpitations,€rapid€heartbeats,€andÐ  L  Ðshortness€of€breath.€€Dr.€Miller€referred€her€to€Dr.€James€W.€Ward,€Jr.,€a€cardiologist€who€hadÐ ø 8  Ðpreviously€evaluated€Ms.€Richardson€in€1987€for€a€similar€complaint.€€Dr.€Ward€placed€Ms.Ð ä $  ÐRichardson€on€a€24„hour€heart€monitor€that€showed€only€benign€changes€in€her€heart€rhythm.€Ð Ð  ÐAccordingly,€Dr.€Ward€reported€to€Dr.€Miller€that€he€recommended€no€additions€to€Ms.€RichardsonððsÐ ¼ü  Ðmedical€care.€€Ms.€Richardson€made€no€other€cardiac€complaints€during€subsequent€office€visits€withÐ ¨è  ÐDr.€Miller.Ð ”Ô  ÐÌà  àMs.€Richardson€made€her€last€prenatal€office€visit€to€Dr.€Miller€on€June€23,€1993,€when€sheÐ l¬ Ðwas€approximately€thirty„five€weeks€pregnant.€€The€checkup€was€routine€and€ended€with€the€doctorððsÐ X˜ Ðoffice€scheduling€her€for€a€return€visit€the€following€week.€€Events,€however,€brought€the€partiesÐ D„ Ðtogether€sooner.€€On€the€afternoon€of€the€very€next€day,€Ms.€Richardson€was€admitted€to€NashvilleÐ 0p ÐMemorial€Hospital€in€labor.€€Dr.€Miller€was€immediately€concerned€that€the€labor€was€premature€andÐ \ Ðthat€there€could€possibly€be€complications€for€the€baby€if€born€at€thirty„five€weeks.€€He€ordered€bedÐ H Ðrest€and€hydration€and€tested€Ms.€Richardson€to€rule€out€mere€uterine€irritability.€€When€theÐ ô4 Ðcontractions€showed€no€signs€of€abating,€Dr.€Miller€opted€to€affirmatively€retard€Ms.€RichardsonððsÐ à  Ðpremature€labor€by€tocolysis,€òòi.e.óó,€giving€her€medication€to€stop€her€contractions€by€relaxing€herÐ Ì  Ðuterine€muscles.Ð ¸ø ÐÌà  àDr.€Miller€first€prescribed€and€administered€magnesium€sulfate€with€limited€success.€€OnÐ Ð ÐJune€24,€1993,€when€the€frequency€of€Ms.€Richardsonððs€contractions€did€not€decrease,€Dr.€MillerÐ |¼ Ðordered€a€different€tocolytic€drug€ð!ð€terbutaline€sulfate€(ð ðterbutalineðð).€€While€terbutaline€had€beenÐ h¨ Ðapproved€by€the€FDA€only€for€treating€bronchial€asthma,€it€was€also€being€widely€used€as€a€tocolyticÐ T ” Ðagent€because€it€relaxes€smooth€muscles,€including€the€muscles€of€the€uterus.€€Ð @!€  ÐÌà  àMs.€Richardson€received€her€first€oral€dose€of€terbutaline€at€approximately€8:30€p.m.€on€JuneÐ #X" Ð24€and€her€second€dose,€again€by€mouth,€four€hours€later.€€Sometime€during€the€early€morning€hoursÐ $D # Ðof€June€25,€she€awoke€with€a€ð ðhorrible€painðð€in€her€chest.€Ms.€Richardson€had€not€gone€back€to€sleepÐ ð$0!$ Ðwhen€a€nurse€came€in€at€approximately€4:00€a.m.€with€a€third€oral€dose€of€terbutaline.€€Ms.Ð Ü%"% ÐRichardson€refused€the€drug,€telling€the€nurse,€as€the€nurseððs€notes€reflect,€that€her€chest€hurt.€€SaidÐ È&#& ÐMs.€Richardson,€ð ðIððm€not€taking€that.€.€.€.€[M]y€chest€is€killing€me.€I€donððt€want€any€more€of€thatÐ ´'ô#' Ðstuff.ðð€Ð  (à$( ÐÌÌà  àThe€next€morning,€the€nursing€staff€informed€Dr.€Miller€that€Ms.€Richardson€had€complainedÐ d+¤'+ Ðof€chest€pain€and€had€refused€to€take€the€third€dose€of€terbutaline.€€When€Dr.€Miller€examined€Ms.Ð P,(, ÐRichardson,€he€discovered€that€her€chest€pains€had€subsided€but€that€she€was€still€in€labor.€€At€thatÐ À Ðpoint,€Dr.€Miller€suggested€using€an€infusion€pump€to€subcutaneously€infuse€smaller,€timed€dosesÐ ¬ì Ðof€terbutaline€into€Ms.Richardsonððs€system.€€Ms.€Richardson€may€not€have€understood€that€the€pumpÐ ˜Ø Ðwould€be€used€to€give€her€the€very€same€drug€that€she€had€earlier€refused€to€take€orally,€but€she€Ð „Ä Ðunderstood€that€the€whole€purpose€of€the€pump€was€to€give€her€medication€to€retard€her€labor€andÐ p° Ðthat€it€was€Dr.€Millerððs€intention€to€stabilize€her€contractions€and€then€to€send€her€home€with€theÐ \œ Ðinfusion€pump€in€place€until€her€pregnancy€was€full€term.Ð H ˆ ÐÌà  àDr.€Miller€had€little€prior€experience€with€terbutaline€infusion€pumps€other€than€attendingÐ  ` Ða€1989€seminar,€conversing€with€a€manufacturerððs€representative,€and€reading€professional€articles.€Ð  L  ÐAfter€completing€his€examination€of€Ms.€Richardson,€Dr.€Miller€directed€the€attending€nurses€toÐ ø 8  Ðcontact€Vanderbilt€University€Hospital€about€arranging€for€a€terbutaline€pump.€€Nurse€Gail€HarrisÐ ä $  Ðwas€eventually€directed€to€Tokos€Medical€Corporation€(ð ðTokosðð),€a€California„based€medicalÐ Ð  Ðservices€and€drug€provider,€who€arranged€to€supply€a€tocolytic€pump€designed€and€programmed€toÐ ¼ü  Ðinfuse€terbutaline€subcutaneously€in€set€doses.€€Other€than€deciding€to€start€Ms.€Richardson€on€theÐ ¨è  Ðpump,€Dr.€Miller€was€not€directly€involved€with€installing€the€pump€or€determining€the€dosage€ofÐ ”Ô  Ðterbutaline€Ms.€Richardson€would€receive€while€on€the€pump.Ð €À ÐÌà  àOn€the€afternoon€of€June€25,€Christine€Evans,€a€nurse€employed€by€Tokos,€arrived€atÐ X˜ ÐMemorial€Hospital€with€the€infusion€pump€ordered€by€Dr.€Miller.€€She€did€not€confer€with€Dr.Ð D„ ÐMiller,€but€instead,€she€reviewed€Ms.€Richardsonððs€medical€records,€talked€with€Ms.€Richardson,Ð 0p Ðand€then€gave€Ms.€Richardson€and€the€hospital€nursing€staff€instructions€concerning€the€use€of€theÐ \ Ðpump.€€After€conferring€with€one€of€Tokosððs€staff€pharmacists,€Ms.€Evans€also€established€theÐ H Ðdosage€of€terbutaline€that€Ms.€Richardson€would€receive.€€The€hospital€staff€then€obtained€theÐ ô4 Ðterbutaline€from€the€hospital€pharmacy,€filled€the€infusion€pump,€inserted€the€needle€that€wouldÐ à  Ðdeliver€the€medication,€and€activated€the€pump.€€As€Ms.€Richardson€remembers€it,€ð ð[t]hey€initiallyÐ Ì  Ðset€it€up,€and€the€[hospital]€nurse€put€the€needle€in.€€And€I€remember€that€every€four€hours€theÐ ¸ø Ðmachine€would€give€[me€a]€dose€[of€medicine].€€And€before€[each]€time€I€was€to€check€my€pulse€rateÐ ¤ä Ðto€see€if€it€was€in€the€range€ð!ð€I€donððt€remember€the€range€that€they€gave€me.ðð€Ð Ð ÐÌà  àMs.€Richardson€received€regular€subcutaneous€doses€of€terbutaline€for€approximately€theÐ h¨ Ðnext€forty„eight€hours.€€Her€labor€contractions€did€not€stop€immediately;€however,€they€eventuallyÐ T ” Ðbegan€to€decrease.€€By€around€noon€on€June€27,€three€days€after€their€onset,€the€contractions€stopped.€Ð @!€  ÐAlthough€Ms.€Richardson€experienced€shakiness€and€what€she€characterized€as€a€ð ðrapid€heart€rate,ððÐ ,"l! Ðthe€nursesðð€notes€stated€that€Ms.€Richardsonððs€vital€signs€were€ð ðstableðð€around€the€time€herÐ #X" Ðcontractions€stopped.€€Ð $D # ÐÌà  àMs.€Richardson€visited€with€her€sister€at€approximately€3:00€p.m.€on€June€27.€€She€becameÐ Ü%"% Ðupset€when€her€sister€told€her€that€their€motherððs€dog€had€died.€€At€that€time,€Ms.€Richardsonððs€chest,Ð È&#& Ðarm,€jaw,€and€head€began€hurting.€€When€a€nurse€arrived,€Ms.€Richardson€exclaimed€that€she€wasÐ ´'ô#' Ðhaving€a€heart€attack€and€insisted€that€she€be€removed€from€the€terbutaline€pump.€€After€someÐ  (à$( Ðconfusion€and€hesitation,€the€nurses€disconnected€Ms.€Richardson€from€the€pump,€and€she€wasÐ Œ)Ì%) Ðsubsequently€transferred€to€a€critical€care€unit€where€an€electrocardiogram€confirmed€that€she€had,Ð x*¸&* Ðin€fact,€experienced€a€heart€attack.Ð d+¤'+ ÐÐ P,(, Ðà  àThat€night€Ms.€Richardson€gave€birth€to€a€healthy,€six„pound€boy.€€A€few€days€later,€Ms.Ð À ÐRichardson€underwent€open„heart€by„pass€surgery€to€repair€a€tear€in€her€coronary€artery€associatedÐ ¬ì Ðwith€her€heart€attack.€€After€recuperating€for€several€days,€Ms.€Richardson€and€her€baby€wereÐ ˜Ø Ðdischarged€from€Memorial€Hospital.€€Ð „Ä ÐÌà  àOn€June€23,€1994,€the€Richardsons€filed€a€medical€malpractice€and€products€liability€actionÐ \œ Ðin€the€Circuit€Court€for€Davidson€County€seeking€$3,500,000€in€compensatory€and€punitive€damagesÐ H ˆ Ðfrom€Dr.€Miller,€Tokos,€and€two€other€defendants.׃×Ý ƒ #ÃÝòòÚ  Ú1Ú  ÚóóÝ  Ý×  ×€€They€alleged€that€the€administration€ofÐ 4 t Ðterbutaline€during€Ms.€Richardsonððs€labor€caused€her€to€suffer€a€heart€attack€resulting€in€permanentÐ  ` Ðheart€damage.€€Later,€the€Principal€Mutual€Life€Insurance€Company€(ð ðPrincipal€Mutualðð),€the€issuerÐ  L  Ðof€Ms.€Richardsonððs€employer„provided€group€health€policy,€sought€to€intervene€as€a€plaintiff€toÐ ø 8  Ðrecover€approximately€$52,000€in€medical€bills€paid€in€connection€with€Ms.€Richardsonððs€heartÐ ä $  Ðattack.€€On€Dr.€Millerððs€motion,€the€trial€court€dismissed€Principal€Mutualððs€complaint€on€the€groundÐ Ð  Ðthat€Tenn.€Code€Ann.€ðð€29„26„119€(1980)€prevented€an€injured€plaintiff€from€seeking€medical€careÐ ¼ü  Ðexpenses€as€damages€when€the€plaintiffððs€insurance€had€paid€those€expenses.€Ð ¨è  ÐÌà  àThe€remaining€parties,€the€Richardsons,€Dr.€Miller,€and€Tokos,€all€requested€a€trial€by€jury.Ð €À ÐIn€anticipation€of€the€trial,€all€sides€moved€in€limine€to€exclude€certain€evidence.€€Dr.€Miller€movedÐ l¬ Ðto€prevent€the€Richardsons€from€introducing€or€using€any€information€from€both€terbutalineððs€drugÐ X˜ Ðpackage€insert€and€the€Physiciansðð€Desk€Reference€(ð ðPDRðð)€indicating€that€the€drug€had€not€beenÐ D„ Ðapproved€by€the€federal€Food€and€Drug€Administration€for€use€in€stopping€premature€labor.׃Ü×Ý ƒ #ÃÝòòÚ  Ú2Ú  ÚóóÝ  Ý×  ×€€TheÐ 0p Ðtrial€court€granted€Dr.€Millerððs€motion.Ð \ ÐÌà  àWhen€the€trial€commenced€in€June€1996,€the€Richardsons€asked€the€trial€court€to€reconsiderÐ ô4 ÐDr.€Millerððs€motion€in€limine.€€Their€request€prompted€Dr.€Miller€to€ask€for€additional€rulingsÐ à  Ðspecifically€precluding€any€reference€at€trial€to€off„label€use€of€terbutaline€taken€from€the€drugððsÐ Ì  Ðpackage€insert,€the€Physiciansðð€Desk€Reference,€or€the€pretrial€deposition€testimony€of€Dr.€MarioÐ ¸ø ÐGaudino,€a€Ciba„Geigy€employee.€€The€trial€court,€siding€with€Dr.€Miller,€prohibited€all€referencesÐ ¤ä Ðat€trial€to€the€off„label€use€of€terbutaline.€€By€the€time€of€trial€in€June€1996,€the€Richardsons€hadÐ Ð Ðnarrowed€their€negligence€claims€against€Dr.€Miller€and€Tokos.€€They€were€no€longer€asserting€thatÐ |¼ ÐDr.€Miller€was€negligent€for€initially€attempting€to€use€orally€administered€terbutaline€to€slow€Ms.Ð h¨ ÐRichardsonððs€labor.€€Rather,€they€were€asserting€that€Dr.€Miller€breached€the€standard€of€care€byÐ T ” Ðcontinuing€tocolysis€using€terbutaline€after€Ms.€Richardson€began€experiencing€chest€pain€whileÐ @!€  Ðtaking€terbutaline€orally€and€by€electing€to€administer€the€terbutaline€subcutaneously€using€anÐ ,"l! Ðinfusion€pump.€€With€regard€to€Tokos,€the€Richardsons€were€asserting€that€the€company€actedÐ #X" Ðnegligently€by€failing€to€inform€Dr.€Miller€that€Ms.€Richardson€was€not€a€candidate€for€the€infusionÐ À Ðpump€under€their€guidelines€because€of€the€advanced€stage€of€her€pregnancy€and€because€of€herÐ ¬ì Ðhistory€and€complaints€of€cardiac€problems€and€by€failing€to€insist€on€an€EKG€before€beginning€Ms.Ð ˜Ø ÐRichardson€on€the€pump.Ð „Ä ÐÌà  àThe€jury€later€returned€a€verdict€in€favor€of€Dr.€Miller€and€Tokos,€and€the€trial€courtÐ \œ Ðsubsequently€entered€judgment€on€the€juryððs€verdict.€€After€the€trial€court€denied€their€motion€forÐ H ˆ Ðnew€trial,€the€Richardsons€perfected€this€appeal.Ð 4 t ÐÌà@¬¬)ìàò òI.ó óˆÐ  L  Ðà@zzìàòòò òThe€Exclusion€of€Evidence€Regarding€the€Off„Label€Use€of€TerbutalineˆÐ ø 8  Ðà@QQ$ìàfor€Tocolysisó óóóˆÐ ä $  ÐÌà  àThe€Richardsons€assert€that€the€trial€court€committed€five€errors€entitling€them€to€a€new€trial.€Ð ¼ü  ÐWe€have€concluded€that€the€dispositive€issue€involves€the€trial€courtððs€decision€to€prevent€theÐ ¨è  ÐRichardsons€from€introducing€evidence€regarding€or€cross„examining€Dr.€Millerððs€or€TokosððsÐ ”Ô  Ðwitnesses€concerning€the€FDA„approved€uses€of€terbutaline,€Ciba„Geigyððs€directions€for€usingÐ €À ÐÔ_ÔterbutalineÔ_Ô,€or€the€off„label€use€of€terbutaline€as€a€tocolytic€agent.€€We€have€determined€that€thisÐ l¬ Ðevidence€is€relevant€and€that€the€trial€court€committed€reversible€error€by€excluding€it.Ð X˜ ÐÌà@‹‹)ìàò òA.ó óˆÐ 0p Ðà@hhìàòòò òThe€FDA€Regulatory€Processó óóóˆÐ \ ÐÌà  àAny€discussion€of€the€admissibility€of€evidence€regarding€the€off„label€use€of€a€prescriptionÐ ô4 Ðdrug€must€begin€with€a€definition€of€the€term€ð ðoff„label€use.ðð€€The€term€is€an€essentially€regulatoryÐ à  Ðconcept€derived€from€the€federal€Food€and€Drug€Administrationððs€(ð ðFDAðð)€regulation€of€prescriptionÐ Ì  Ðdrugs€and€their€labeling.€€òòSeeóó€James€M.€Beck€&€Elizabeth€D.€Azari,€òòFDA,€Off„Label€Uses,€andÐ ¸ø ÐInformed€Consent:€Debunking€Myths€and€Misconceptionsóó,€53€Food€&€Drug€L.J.€71,€83€(1998)Ð ¤ä Ð(ð ðBeck€&€Azariðð);€Steven€R.€Salbu,€òòOff„Label€Use,€Prescription€and€Marketing€of€FDA„ApprovedÐ Ð ÐDrugs:€An€Assessment€of€Legislative€and€Regulatory€Policyóó,€51€Fla.€L.€Rev.€181,€186€(1999)Ð |¼ Ð(ð ðSalbuðð).€€The€term,€as€customarily€used€by€health€care€providers,€is€medically€neutral€and€refersÐ h¨ Ðto€a€circumstance€in€which€a€patient€uses€a€prescribed€drug€or€device€in€a€manner€that€varies€in€someÐ T ” Ðway€from€the€drugððs€or€deviceððs€FDA„approved€labeling.€€òòSeeóó€Beck€&€Azari,€53€Food€&€Drug€L.J.Ð @!€  Ðat€85;€Lucinda€M.€Finley,€òòGuarding€the€Gate€to€the€Courthouse:€How€Trial€Judges€Are€Using€TheirÐ ,"l! ÐEvidentiary€Screening€Role€to€Remake€Tort€Causation€Rulesóó,€49€DePaul€L.€Rev.€335,€368€(1999);Ð #X" ÐSalbu,€51€Fla.€L.€Rev.€at€188.׃×Ý ƒ #ÃÝòòÚ  Ú3Ú  ÚóóÝ  Ý×  ×€€Because€the€term€is€linked€so€closely€with€the€FDAððs€oversight€ofÐ $D # Ðprescription€drugs,€it€cannot€be€fully€understood€without€some€basic€understanding€of€the€FDAððsÐ À Ðprocedures€for€approving€the€promotion€and€sale€of€prescription€drugs.Ð ¬ì ÐÌà  àThe€federal€Food,€Drug,€and€Cosmetic€Act€(ð ðFDCAðð)€and€its€later€amendments€were€enactedÐ „Ä Ðto€prevent€wide„spread€tragedies€such€as€those€involving€sulfanilamide׃Ü×Ý ƒ #ÃÝòòÚ  Ú4Ú  ÚóóÝ  Ý×  ×€and€thalidomide€byÐ p° Ðimproving€the€manufacture,€testing,€and€labeling€of€prescription€drugs.€€òòSeeóó€Note,€òòThe€DrugÐ \œ ÐAmendments€of€1962:€€How€Much€Regulation?óó,€18€Rutgers€L.€Rev.€101,€115€(1963).€€The€premiseÐ H ˆ Ðof€the€legislation€is€that€a€federal€agency€is€necessary€to€protect€consumers€from€the€products€of€aÐ 4 t Ðprofit„seeking€drug€industry€bent€on€increasing€its€sales€and€profits.€€òòSeeóó€James€R.€Bird,€òòPackageÐ  ` ÐInserts€for€Prescription€Drugs€€as€Evidence€in€Medical€Malpractice€Casesóó,€44€U.€Chi.€L.€Rev.€398,Ð  L  Ð406€(1977)€(ð ðBirdðð).€€Under€the€FDCA,€a€manufacturer€cannot€market€or€sell€a€new€prescription€drugÐ ø 8  Ðwithout€first€obtaining€FDA€approval.€€òòSeeóó€21€U.S.C.A.€ðð€355(a)€(West€1999).€€Ð ä $  ÐÌ€à  àThe€FDAððs€approval€process€begins€when€a€manufacturer€submits€a€new€drug€application.€Ð ¼ü  ÐThis€application€must€include€detailed€information€regarding€the€drug,€including€(1)€its€components,Ð ¨è  Ð(2)€its€manufacturing€process,€(3)€samples€of€the€drug,€(4)€studies€conducted€to€determine€the€drugððsÐ ”Ô  Ðsafety€and€efficacy€for€a€particular€use€or€uses,€and€(5)€the€proposed€labeling€for€the€drug.€€òòSeeóó€21Ð €À ÐU.S.C.A.€ðð€355(b)(1);€21€C.F.R.€ðððð€314.50,€807.87(e)€(1999).€€The€FDAððs€consideration€of€a€newÐ l¬ Ðdrug€application€is€limited€to€the€use€or€uses€for€which€the€manufacturer€has€conducted€safety€andÐ X˜ Ðefficacy€studies.€€òòSeeóó€21€U.S.C.A.€ðð€360e(d)(1)(A)€(West€1999);€21€C.F.R.€ðððð€314.50,€„.54,€Ð D„ Ð807.92(a)(5),€807.100(b)(1)€(1999);€òòsee€also€Washington€Legal€Found.€v.€Friedmanóó,€13€F.€Supp.€2dÐ 0p Ðat€55;€Salbu,€51€Fla.€L.€Rev.€at€187.Ð \ ÐÌà  àAfter€receiving€the€new€drug€application€and€the€supporting€data,€the€FDA€conducts€a€risk„Ð ô4 Ðbenefit€analysis€to€ascertain€the€new€drugððs€safety€and€therapeutic€effectiveness€for€the€intended€useÐ à  Ðor€uses€specified€by€its€manufacturer.€€òòSeeóó€Margaret€Gilhooley,€òòWhen€Drugs€Are€Safe€For€Some€ButÐ Ì  ÐNot€Others:€€Ô_ÔTheÔ_Ô€FDA€Experience€and€Alternatives€for€Products€Liabilityóó,€36€Hous.€L.€Rev.€927,€928Ð ¸ø Ð(1999)€(ð ðGilhooleyðð),€òòcitingóó€FDA,€U.S.€Depððt€of€Health€&€Human€Servs.,€òòManaging€the€Risks€FromÐ ¤ä ÐMedical€Product€Use,€Creating€a€Management€Frameworkóó,€Report€to€the€FDA€Commððr€from€theÐ Ð ÐTask€Force€on€Risk€Management€21€(1999);€Sidney€A.€Shapiro,€òòLimiting€Physician€Freedom€toÐ |¼ ÐPrescribe€a€Drug€for€Any€Purpose:€The€Need€for€FDA€Regulationóó,€73€Nw.€U.L.€Rev.€801,€805Ð h¨ Ð(1978)€(ð ðShapiroðð).€€Once€the€FDA€determines€that€the€new€drug€is€safe€and€effective,€the€FDA€andÐ T ” Ðthe€drugððs€manufacturer€negotiate€the€language€to€be€included€in€the€drugððs€labeling.€€òòSeeóó€Bird,€44Ð @!€  ÐU.€Chi.€L.€Rev.€at€410.Ð ,"l! Ðâ âÐ #X" Ðà  àThe€labeling׃ ×Ý ƒ #ÃÝòòÚ  Ú5Ú  ÚóóÝ  Ý×  ×€submitted€by€a€drug€manufacturer€must€be€limited€to€the€intended€use€or€usesÐ À Ðâ âof€the€drug.€€Manufacturers€are€neither€required€nor€expected€to€submit€labeling€reflecting€all€of€aÐ ¬ì Ðdrugððs€possible€uses.€€òòSeeóó€21€C.F.R.€807.87(e).€€The€purpose€of€labeling€to€ensure€that€a€drugððsÐ ˜Ø Ðpromotional€literature€contains€accurate€and€complete€information€regarding€the€approved€use€orÐ „Ä Ðuses€and€known€risks€of€the€drug.€€òòSeeóó€Lars€Noah,òò€The€Imperative€to€Warn:€Disentangling€the€ð ðRightÐ p° Ðto€Knowðð€from€the€ð ðNeed€to€Knowðð€About€Consumer€Product€Hazardsóó,€11€Yale€J.€on€Reg.€293,Ð \œ Ð326„333€(1994).€€Thus,€the€labeling€must€include€information€necessary€for€the€safe€and€effectiveÐ H ˆ Ðuse€of€the€drug,€such€as€dosage€and€methods€of€administration,€as€well€as€warnings,€precautions,Ð 4 t Ðindications€and€contraindications,€drug€abuse€and€dependence,€and€adverse€reactions.€€òòSeeóó€21€C.F.R.Ð  ` Ððððð€201.56,€201.57€(1999).€€The€FDA€will€not€approve€a€new€drug€until€it€finds€the€proposed€labelingÐ  L  Ðacceptable.€€In€particular,€the€FDA€will€not€approve€a€new€drug€application€if€the€labeling€containsÐ ø 8  Ðinstructions€regarding€uses€other€than€those€for€which€the€drug€has€been€shown€to€be€safe€andÐ ä $  Ðeffective.€€òòSeeóó€21€U.S.C.A.€ðð€355(d)(1);€David€W.€Opderbeck,€òòHow€Should€FDA€RegulateÐ Ð  ÐPrescription€Drug€Promotion€on€the€Internet?óó€53€Food€&€Drug€L.J.€47,€55€(1998);€Salbu,€51€Fla.Ð ¼ü  ÐL.€Rev.€at€187;€Kaspar€I.€Stoffelmayr,€Comment,€òòProducts€Liability€and€ð ðOff„Labelðð€Uses€ofÐ ¨è  ÐPrescription€Drugsóó,€63€U.€Chi.€L.€Rev.€275,€276€(1996)€(ð ðStoffelmayrðð).Ð ”Ô  ÐÌà  àThe€FDA„required€labeling€includes€the€package€inserts€that€accompany€the€drug.€€The€sameÐ l¬ Ðinformation€is€also€included€in€the€PDR,€an€encyclopedia€of€medications€written€and€publishedÐ X˜ Ðannually€and€provided€to€all€practicing€physicians.€€òòSee€Spensieri€v.€Laskyóó,€723€N.E.2d€544,€547Ð D„ Ð(N.Y.€1999);€Edmund€Polubinski,€III,€Note,€òòClosing€the€Channels€of€Communication:€A€FirstÐ 0p ÐAmendment€Analysis€of€the€FDAððs€Policy€on€Manufacturer€Promotion€of€ð ðOff„Labelðð€Useóó,€83€Va.Ð \ ÐL.€Rev.€991,€995€(1997).€€Both€the€drugððs€labeling€and€the€parallel€PDR€reference€are€directed€at€theÐ H Ðphysicians€who€prescribe€the€drug€rather€than€at€the€patients€who€will€be€taking€it.€€òòSee€óóSalbu,€51€Fla.Ð ô4 ÐL.€Rev.€at€187.€€To€comply€with€FDA€regulations,€the€information€in€a€drugððs€PDR€reference€mustÐ à  Ðbe€the€same€as€the€information€in€the€FDA„approved€labeling€and€package€inserts.€€òòSeeóó€21€C.F.R.Ð Ì  Ððð€201.100(d)(2)€(1999).Ð ¸ø ÐÌà  àThe€instructions€and€warnings€contained€in€a€prescription€drugððs€labeling€and€its€parallel€PDRÐ Ð Ðreference€are€the€primary€way€of€insuring€the€drugððs€safe€use.€€Physicians€are€expected€to€take€theÐ |¼ Ðinformation€into€account€when€prescribing€the€drug.€€òòSeeóó€Gilhooley,€36€Hous.€L.€Rev.€at€939.€Ð h¨ ÐPackage€inserts,€as€reprinted€in€the€PDR,€are€now€the€most€frequently€consulted€source€ofÐ T ” Ðinformation€on€the€use€of€prescription€drugs.€€At€least€one€Congressional€committee€has€receivedÐ @!€  Ðevidence€suggesting€that€physicians€not€only€consult€the€package€inserts€or€the€parallel€PDRÐ ,"l! Ðreferences€but€that€they€also€rely€on€them€when€making€decisions€on€dosage€and€method€ofÐ #X" Ðadministration.€€òòSeeóó€òòMorlino€v.€Medical€Ctr.óó,€706€A.2d€721,€729€(N.J.€1998);€Bird,€44€U.€Chi.€L.Ð $D # ÐRev.€at€416,€òòcitingóó€òòExamination€of€the€Pharmaceutical€Industry,€1973„74,€Hearings€on€S.€3441€andÐ ð$0!$ ÐS.€966€Before€the€Subcomm.€on€Health€of€the€Sen.€Comm.€on€Labor€and€Pub.€Welfareóó,€93rd€Cong.,Ð Ü%"% Ð1st€&€2d€Sess.,€pt.€5,€at€1548€(1973„74).Ð È&#& ÐÐ ´'ô#' Ðà  àThe€FDAððs€approval€of€a€new€drug€does€not€end€its€oversight€of€the€drugððs€use.€€Both€theÐ À ÐFDA€and€the€manufacturer€must€continue€to€collect€positive€and€negative€information€regarding€theÐ ¬ì Ðactual€safety€and€efficacy€of€the€drug€on€patients.€€The€FDA€regulations€emphasize€the€collection€ofÐ ˜Ø Ðnegative€information€regarding€the€clinical€experience€with€a€prescription€drug€ð ðto€make€or€facilitateÐ „Ä Ða€determination€of€whether€there€are€or€may€be€grounds€.€.€.€for€suspending€or€withdrawing€approvalÐ p° Ðof€the€application.ðð€€21€C.F.R.€ðð€310.303(a)€(1999).€€If€the€off„label€use€of€a€prescription€drugÐ \œ Ðbecomes€widespread€or€endangers€the€public€health,€the€FDA€is€obligated€to€investigate€it€thoroughlyÐ H ˆ Ðand€to€take€whatever€action€is€warranted€to€protect€the€public.€€òòSeeóó€Legal€Status€of€ApprovedÐ 4 t ÐLabeling€for€Prescription€Drugs:€Prescribing€for€Uses€Unapproved€By€the€FDA,€37€Fed.€Reg.€16,503,Ð  ` Ð16,504€(to€be€codified€at€21€C.F.R.€pt.€130)€(proposed€Aug.€14,€1972);׃&×Ý ƒ #ÃÝòòÚ  Ú6Ú  ÚóóÝ  Ý×  ×€Stuart€L.€Nightengale,Ð  L  ÐòòUnlabeled€Uses€of€Approved€Drugsóó,€26€Drug€Info.€J.€141,€143€(1992).׃!T×Ý ƒ #ÃÝòòÚ  Ú7Ú  ÚóóÝ  Ý×  ×€€The€FDA€may€withdrawÐ ø 8  Ðapproval€of€a€drug€if€new€information€indicates€that€the€drug€is€not€safe€and€effective€for€use€underÐ ä $  Ðthe€conditions€discussed€in€the€drugððs€labeling,€€òòseeóó€21€C.F.R.€ðð€314.150(a)(2)(i)€(1999),€or€it€mayÐ Ð  Ðrequire€the€manufacturer€to€include€statements€in€the€drugððs€labeling€that€certain€uses€areÐ ¼ü  Ðcontraindicated.€€òòSeeóó€21€C.F.R.€ðððð€201.57(d),€801.109€(1999).Ð ¨è  ÐÌà  àOnce€the€FDA€has€approved€a€prescription€drug€for€a€particular€use€or€uses,€the€drugððsÐ €À Ðmanufacturer€cannot€market€or€promote€the€drug€for€an€off„label€use€until€it€resubmits€the€drug€forÐ l¬ Ðanother€series€of€clinical€trials€similar€to€those€required€for€initial€approval€of€a€new€drug€application.€Ð X˜ ÐòòSeeóó€21€C.F.R.€ðððð€314.54,€314.70,€„.71€(1999);€òòWashington€Legal€Found.€v.€Friedmanóó,€13€F.€Supp.Ð D„ Ð2d€at€55;€Salbu,€51€Fla.€L.€Rev.€at€187„88.€€As€new€uses€for€an€already€approved€drug€becomeÐ 0p Ðknown,€the€drugððs€manufacturer€may€request€the€FDAððs€approval€to€add€new€approved€uses€to€theÐ \ Ðdrugððs€labeling.€€òòSeeóó€Richard€A.€Merrill,€òòThe€Architecture€of€Government€Regulation€of€MedicalÐ H ÐProductsóó,€82€Va.€L.€Rev.€1753,€1775€(1996)€(ð ðMerrillðð);€Glenn€C.€Smith,€òòAvoiding€AwkwardÐ ô4 ÐAlchemy€ð!ð€In€the€Off„Label€Drug€Context€and€Beyond:€Fully€Protected€Independent€ResearchÐ à  ÐShould€Not€Transmogrify€Into€Mere€Commercial€Speech€Just€Because€Product€ManufacturersÐ Ì  ÐDistribute€Itóó,€34€Wake€Forest€L.€Rev.€963,€969€(1999)€(ð ðSmithðð).€€Because€of€the€time€and€expenseÐ ¸ø Ðof€obtaining€FDA€approval€of€new€uses€for€an€already€approved€drug,€drug€manufacturers€frequentlyÐ ¤ä Ðdo€not€voluntarily€request€FDA€approval€for€a€new€use€unless€the€change€in€the€labeling€will€pay€forÐ Ð Ðitself€in€increased€profits.€€òòSeeóó€J.€Howard€Beales,€III,€òòEconomic€Analysis€and€the€Regulation€ofÐ |¼ ÐPharmaceutical€Advertisingóó,€24€Ô_ÔSetonÔ_Ô€Hall€L.€Rev.€1370,€1387,€1392„93€(1994);€Bird,€44€U.€Chi.Ð h¨ ÐL.€Rev.€at€412;€Merrill,€82€Va.€L.€Rev.€at€1855;€Salbu,€51€Fla.€L.€Rev.€at€188;€Shapiro,€73€Nw.€U.L.Ð T ” ÐRev.€at€811;€Stoffelmayr,€63€U.€Chi.€L.€Rev.€at€277.Ð @!€  ÐÌÌÌÌà@)ìàò òB.ó óˆÐ Ü%"% Ðà@  ìàòòò òOff„Label€Use€of€Prescription€Drugsó óóóˆÐ È&#& Ðâ âÐ ´'ô#' Ðà  àThe€FDAððs€broad€authority€over€prescription€drugs€and€devices€does€not€extend€to€aÐ À Ðâ âphysicianððs€decisions€regarding€the€use€of€these€products.€€òòSee€Washington€Legal€Found.€v.Ð ¬ì ÐFriedmanóó,€13€F.€Supp.€2d€at€55;€Beck€&€Azari,€53€Food€&€Drug€L.J.€at€76;€Smith,€34€Wake€ForestÐ ˜Ø ÐL.€Rev.€at€969.€€To€avoid€limiting€the€ability€of€physicians€to€treat€their€patients,׃"×Ý ƒ #ÃÝòòÚ  Ú8Ú  ÚóóÝ  Ý×  ×€the€lack€of€FDAÐ „Ä Ðapproval€of€a€drug€or€device€for€a€particular€use€does€not€imply€that€using€the€drug€or€device€for€thatÐ p° Ðuse€is€either€disapproved€or€improper.€€òòSeeóó€Beck€&€Azari,€53€Food€&€Drug€L.J.€at€83„84.׃#×Ý ƒ #ÃÝòòÚ  Ú9Ú  ÚóóÝ  Ý×  ×€€Thus,Ð \œ Ðphysicians€may€use€approved€drugs€or€devices€in€any€way€that€they,€in€their€professional€judgment,Ð H ˆ Ðbelieve€will€best€serve€their€patients,€regardless€of€whether€the€FDA€has€approved€the€drug€or€deviceÐ 4 t Ðfor€that€particular€use.€€òòSee€Washington€Legal€Found.€v.€Henneyóó,€202€F.3d€331,€333€(D.C.€Cir.€2000);Ð  ` ÐòòUnited€States€v.€Eversóó,€643€F.2d€1043,€1048€(5th€Cir.€1981);€òòProctor€v.€Davisóó,€682€N.E.2d€1203,Ð  L  Ð1206€n.1€(Ill.€App.€Ct.€1997);òò€Femrite€v.€Abbott€Northwestern€Hosp.óó,€568€N.W.2d€535,€541€(Minn.Ð ø 8  ÐCt.€App.€1997);€òòKlein€v.€Biscupóó,€673€N.E.2d€225,€231€(Ohio€Ct.€App.€1996).€€This€prerogativeÐ ä $  Ðincludes€(1)€prescribing€a€drug€for€conditions€other€than€those€for€which€it€has€been€approved,€(2)Ð Ð  Ðprescribing€a€drug€for€patient€groups€other€than€those€for€which€it€was€originally€approved,€and€(3)Ð ¼ü  Ðvarying€the€dosage€or€method€of€administering€a€drug€from€that€contained€in€its€labeling.€€òòSeeóóÐ ¨è  ÐStoffelmayr,€63€U.€Chi.€L.€Rev.€at€277.Ð ”Ô  ÐÌà  àIn€the€current€regulatory€environment,€when€the€FDA€authorizes€a€prescription€drug€or€deviceÐ l¬ Ðto€be€marketed,€it€is€well€aware€that€the€drug€or€device€will€likely€be€put€to€an€off„label€use.€€òòSeeÐ X˜ ÐóóBeck€&€Azari,€53€Food€&€Drug€L.J.€at€82.€€The€FDA€has€acknowledged€that€once€a€drug€or€deviceÐ D„ Ðis€on€the€market,€a€ð ðphysician€may,€as€part€of€the€practice€of€medicine,€lawfully€prescribe€a€differentÐ 0p Ðdosage€for€his€[or€her]€patient€or€may€otherwise€vary€the€conditions€of€use€from€those€approved€inÐ \ Ðthe€package€insert,€without€informing€or€obtaining€the€approval€of€the€Food€and€DrugÐ H ÐAdministration.ðð€€Legal€Status€of€Approved€Labeling€For€Prescription€Drugs:€Prescribing€For€UsesÐ ô4 ÐUnapproved€by€the€FDA,€37€Fed.€Reg.€16,503,€16,504€(to€be€codified€at€21€C.F.R.€pt.€130)€(proposedÐ à  ÐAug.€14,€1972).׃$´×Ý ƒ #ÃÝòòÚ  Ú10Ú  ÚóóÝ  Ý×  ×€€An€FDA€technical€bulletin€has€recognized€that€the€off„label€use€of€an€approvedÐ Ì  Ðdrug€represents€acceptable,€and€sometimes€essential,€clinical€practice.€€òòSeeóó€òòUse€of€Unapproved€DrugsÐ ¸ø Ðfor€Unlabeled€Indicationsóó,€12€FDA€Drug€Bull.,€Apr.€1982,€at€4„5,€cited€in€59€Fed.€Reg.€59,820,Ð ¤ä Ðâ â59,821€(noting€that€ð ð[v]alid€new€uses€for€drugs€already€on€the€market€are€often€first€discoveredÐ Ð Ðthrough€serendipitous€observation€and€therapeutic€innovationðð).׃%×Ý ƒ #ÃÝòòÚ  Ú11Ú  ÚóóÝ  Ý×  ×€€It€is€also€possible€that€the€off„labelÐ À Ðâ âuses€of€a€drug€may€exceed€the€uses€for€which€the€drug€was€originally€approved.€€òòSeeóó€John€Calfee,Ð ¬ì ÐòòFree€Speech,€FDA€Regulation,€and€Market€Effects€on€the€Pharmaceutical€Industry,€reprinted€in€BadÐ ˜Ø ÐPrescription€for€the€First€Amendment:€FDA€Censorship€of€Drug€Advertising€and€Promotionóó€64Ð „Ä Ð(Richard€T.€Kaplar,€ed.€1993).Ð p° ÐÌà  àOff„label€prescriptions€are€now€an€integral€part€of€the€modern€practice€of€medicine.€€òòSeeÐ H ˆ ÐWashington€Legal€Found.€v.€Henneyóó,€202€F.3d€at€333.€€While€estimates€concerning€the€prevalenceÐ 4 t Ðof€off„label€use€varies,€there€is€a€consensus€that€the€practice€is€widespread.€€òòSeeóó€Beck€&€Azari,€53Ð  ` ÐFood€&€Drug€L.J.€at€80;€Lars€Noah,€òòConstraints€on€the€Off„Label€Prescription€Drugsóó,€16€J.€Prods.Ð  L  Ð&€Toxics€Liab.€139,€139€(1994);€United€States€General€Accounting€Office,€òòOff„Label€Drugs,Ð ø 8  ÐReimbursement€Policies€Constrain€Physicians€in€Their€Choice€of€Cancer€Therapiesóó,€GAO/PEMD„Ð ä $  Ð91„14,€at€5€(Sept.€1991)€(ð ðGAO€Reportðð).€€Off„label€uses€of€approved€drugs€have€become€extremelyÐ Ð  Ðimportant€in€specialities€such€as€cancer,׃(d×Ý ƒ #ÃÝòòÚ  Ú12Ú  ÚóóÝ  Ý×  ×€pediatric€medicine,׃) ×Ý ƒ #ÃÝòòÚ  Ú13Ú  ÚóóÝ  Ý×  ×€heart€and€circulatory€disease,׃*Ø ×Ý ƒ #ÃÝòòÚ  Ú14Ú  ÚóóÝ  Ý×  ×Ð ¼ü  ÐAIDS,׃+(×Ý ƒ #ÃÝòòÚ  Ú15Ú  ÚóóÝ  Ý×  ×€and€kidney€disease.׃,<×Ý ƒ #ÃÝòòÚ  Ú16Ú  ÚóóÝ  Ý×  ×Ð ¨è  ÐÌà  àRecognition€of€the€propriety€of€the€off„label€use€of€drugs€and€devices€has€spread€beyond€theÐ €À Ðmedical€profession.€€A€number€of€state€legislatures,€including€the€Tennessee€General€Assembly,€haveÐ l¬ Ðrecognized€that€off„label€uses€of€approved€drugs€are€appropriate€ways€to€provide€medical€care€atÐ X˜ Ðlower€costs€and€have€precluded€medical€insurers€from€declining€to€pay€for€approved€drugs€prescribedÐ D„ Ðoff„label€solely€because€the€FDA€has€not€approved€the€drug€for€that€use.€€òòSeeóó€Tenn.€Code€Ann.€ðð€56„Ð 0p Ð7„2352(a)(6)„(7),€„2352(c)(1);€Beck€&€Azari,€53€Food€&€Drug€L.J.€at€76€n.56.€€The€courts€have€also€Ð \ Ðrepeatedly€recognized€the€legitimacy€of€the€off„label€use€of€approved€drugs€and€devices.€€òòSee€Rhone„Ð H ÐPoulenc€Rorer€Pharm.,€Inc.€v.€Marion€Merrell€Dow,€Inc.óó,€93€F.3d€511,€514€n.33€(8th€Cir.€1996);Ð À ÐòòBristol„Myers€Squibb€Co.€v.€Shalalaóó,€91€F.3d€1493,€1496€(D.C.€Cir.€1996);€òòOrtho€Pharm.€Corp.€v.Ð ¬ì ÐCosprophar,€Inc.óó,€32€F.3d€690,€692€(2d€Cir.€1994);€òòWeaver€v.€Reagenóó,€886€F.2d€at€198;€òòAlvarez€v.Ð ˜Ø ÐSmithóó,€714€So.€2d€652,€653„54€(Fla.€Dist.€Ct.€App.€1998);€òòKlein€v.€Biscupóó,€673€N.E.2d€at€231;Ð „Ä ÐòòSouthard€v.€Temple€Univ.€Hosp.óó,€731€A.2d€603,€611€(Pa.€Super.€Ct.€1999).€€Ð p° ÐÌà  àThe€off„label€use€of€approved€drugs€results€in€one€significant€complication€for€physicians.€Ð H ˆ ÐBecause€of€the€FDAððs€restrictions€on€the€dissemination€of€information€regarding€off„label€uses€ofÐ 4 t Ðapproved€drugs,€physicians€do€not€have€readily€available€the€same€information€concerning€the€use,Ð  ` Ðdosage,€and€method€of€administration€of€the€drug€that€is€provided€for€approved€uses.€€Neither€theÐ  L  ÐFDA„approved€labeling€nor€the€parallel€PDR€reference€contain€information€about€off„label€uses.€€òòSeeÐ ø 8  ÐWashington€Legal€Found.€v.€Friedmanóó,€13€F.€Supp.€at€56.׃1×Ý ƒ #ÃÝòòÚ  Ú17Ú  ÚóóÝ  Ý×  ×€€Ð ä $  ÐÌà  àWhen€the€off„label€use€of€a€drug€becomes€widespread,€there€is€an€increased€possibility€thatÐ ¼ü  Ða€physician€with€inadequate€knowledge€will€prescribe€it.€€òòSeeóó€Shapiro,€73€Nw.€U.L.€Rev.€at€826.€Ð ¨è  ÐAccordingly,€physicians€prescribing€a€drug€or€device€off„label€have€a€responsibility€to€be€well„Ð ”Ô  Ðinformed€about€the€drug€or€device.€€òòSee€Staudt€v.€Ô_ÔFroedtertÔ_Ô€Ô_ÔMemððlÔ_Ô€Lutheran€Hosp.óó,€580€N.W.2d€361,Ð €À Ð363€(Wis.€Ct.€App.€1998);€òòFemrite€v.€Abbott€Midwestern€Hosp.óó,€568€N.W.2d€at€542;€Cynthia€Starr,Ð l¬ ÐòòA€Careful€Approach€to€Off„Label€Drugsóó,€Patient€Care€(Sept.€30,€1999)€(visited€July€6,€2000)Ð X˜ Ð.€€In€theÐ D„ Ðabsence€of€the€information€found€in€the€FDA„approved€labeling,€physicians€must€obtain€reliable,€up„Ð 0p Ðto„date€information€from€other€sources.€€These€sources€may€include:€(1)€discussion€with€professionalÐ \ Ðcolleagues,€(2)€continuing€medical€education€programs,€(3)€case€studies€in€professional€journals,€andÐ H Ð(4)€reports€of€the€clinical€results€of€the€use€of€the€drug€in€other€countries.€€òòSee€Baker€v.€Danec€Ô_ÔMed.óó,Ô_ÔÐ ô4 Ð35€F.€Supp.€2d€865,€873€(N.D.€Fla.€1998);€òòWashington€Legal€Found.€v.€Friedmanóó,€13€F.€Supp.€2dÐ à  Ðat€56;€Shapiro,€73€Nw.€U.€L.€Rev.€at€809„10.€Ð Ì  ÐÌà@‹‹)ìàò òC.ó óˆÐ ¤ä Ðà@§§ìàòòò òAdmissibility€of€Evidence€That€a€Particular€Use€of€a€Drug€is€Off„Labeló óóóˆÐ Ð ÐÌà  àThe€next€issue€to€be€addressed€is€whether€a€prescription€drugððs€labeling€or€parallel€PDRÐ h¨ Ðreference€is€admissible€with€regard€to€the€standard€of€care€for€using€and€administering€the€drug.€Ð T ” ÐVirtually€every€court€addressing€this€question€has€concluded€that€the€drugððs€labeling€and€PDRÐ @!€  Ðreference€are€relevant€to€the€standard€of€care€issue.€€The€primary€dispute€among€the€courts€involvesÐ ,"l! Ðthe€weight€to€be€given€to€this€evidence.€€The€great€weight€of€authority€is€that€a€drugððs€labeling€or€itsÐ #X" Ðparallel€PDR€reference€is€admissible,€as€long€as€it€is€accompanied€by€other€expert€evidence€regardingÐ $D # Ðthe€standard€of€care.Ð ð$0!$ ÐÌà  àA€plaintiffððs€burden€of€proof€in€a€medical€malpractice€case€is€governed€by€statute.€€As€aÐ È&#& Ðgeneral€matter,€the€law€will€not€presume€that€a€health€care€provider€acted€negligently€simply€becauseÐ ´'ô#' Ða€treatment€was€unsuccessful.€€òòSeeóó€Tenn.€Code€Ann.€ðð€29„26„115(c)€(1980);€€òòRoddy€v.€VolunteerÐ À ÐMed.€Clinic,€Inc.óó,€926€S.W.2d€572,€578€(Tenn.€Ct.€App.€1996).׃9×Ý ƒ #ÃÝòòÚ  Ú18Ú  ÚóóÝ  Ý×  ×€€Thus,€in€order€to€make€out€a€primaÐ ¬ì Ðfacie€case€of€medical€negligence,€a€plaintiff€must€come€forward€with€evidence€that€complies€withÐ ˜Ø ÐTenn.€Code€Ann.€ðð€29„26„115(a).€€This€statute€requires€the€conduct€of€health€care€providers€to€beÐ „Ä Ðjudged€by€an€objective€community€standard.€€Accordingly,€Tenn.€Code€Ann.€ðð€29„26„115(a)(1)Ð p° Ðrequires€the€plaintiff€to€present€evidence€of€ð ð[t]he€recognized€standard€of€acceptable€professionalÐ \œ Ðpractice€in€the€profession€and€the€specialty€thereof€.€.€.€that€the€defendant€practices€in€the€communityÐ H ˆ Ðin€which€he€[or€she]€practices€.€.€.€at€the€time€the€alleged€injury€or€wrongful€action€occurred.ðð€Ð 4 t ÐEstablishing€this€professional€standard€of€care€requires€expert€testimony.€€òòSee€Moon€v.€St.€ThomasÐ  ` ÐHosp.óó,€983€S.W.2d€225,€229€(Tenn.€1998);€òòCardwell€v.€Bechtolóó,€724€S.W.2d€739,€742€(Tenn.€1987);òòÐ  L  ÐJennings€v.€Caseóó,€10€S.W.3d€625,€627€(Tenn.€Ct.€App.€1999).Ð ø 8  ÐÌà  àPlaintiffs€in€other€medical€malpractice€cases€have€argued€that€the€instructions€in€aÐ Ð  Ðprescription€drugððs€FDA„approved€labeling€or€the€parallel€PDR€reference€should€be€sufficient,€byÐ ¼ü  Ðthemselves,€to€establish€a€physicianððs€standard€of€care€regarding€the€use€of€the€drug.€€SeveralÐ ¨è  Ðjurisdictions,€believing€drug€manufacturers€to€be€uniquely€knowledgeable€about€the€proper€use€ofÐ ”Ô  Ðtheir€products,€have€held€that€a€drugððs€labeling€or€its€parallel€PDR€reference€amounts€to€prima€facieÐ €À Ðevidence€of€the€standard€of€care€as€far€as€the€use€of€that€drug€is€concerned.׃-Ü×Ý ƒ #ÃÝòòÚ  Ú19Ú  ÚóóÝ  Ý×  ×€€However,€a€majorityÐ l¬ Ðof€jurisdictions€have€determined€that€a€prescription€drugððs€labeling€or€parallel€PDR€reference€isÐ X˜ Ðadmissible€to€prove€the€standard€of€care,€but€only€if€the€plaintiff€also€introduces€other€expertÐ D„ Ðtestimony€regarding€the€standard€of€care.€€These€jurisdictions€have€concluded€that€while€the€labelingÐ 0p Ðand€PDR€reference€provide€relevant€and€useful€information€regarding€the€standard€of€care,€they€areÐ \ Ðnot€the€sole€determinant€of€the€standard€of€care€because,€in€any€particular€case,€adhering€to€theÐ H Ðmanufacturerððs€recommendations€and€warnings€in€the€labeling€or€the€PDR€may€or€may€not€have€beenÐ ô4 Ðwithin€the€standard€of€care€when€the€alleged€negligent€act€occurred.׃/ð×Ý ƒ #ÃÝòòÚ  Ú20Ú  ÚóóÝ  Ý×  ×€Ð à  ÐÌà  àFour€considerations€support€the€majority€view€governing€the€admissibility€of€a€prescriptionÐ ¸ø Ðdrugððs€labeling€or€parallel€PDR€reference€in€a€medical€malpractice€case.€€First,€permitting€theÐ ¤ä Ðlabeling€or€the€PDR€reference€alone€to€establish€a€physicianððs€standard€of€care€would€be€inconsistentÐ Ð Ðwith€Tenn.€Code€Ann.€ðð€29„26„115(a)(1)€because€it€would€permit€the€drug€manufacturer,€rather€thanÐ |¼ Ðthe€medical€profession,€to€establish€the€standard€of€care.€€òòSee€Morlino€v.€Medical€Ctr.óó,€706€A.2d€atÐ h¨ Ð730;€òòSpensieri€v.€Laskyóó,€723€N.E.2d€at€548.€€Second,€the€FDA„required€labeling€and€parallel€PDRÐ T ” Ðreference€may€not€be€easily€understood€by€the€jury€without€expert€assistance€because€these€materialsÐ @!€  Ðare€written€for€the€medical€profession,€not€the€general€public.€€òòSee€Craft€v.€Peeblesóó,€893€P.2d€at€151Ð À Ðn.17;€òòMorlino€v.€Medical€Ctróó.,€706€A.2d€at€729„30;€òòSpensieri€v.€Lasky,óó€723€N.E.2d€at€548.€€Third,Ð ¬ì Ðthe€drug€manufacturer€and€the€FDA€do€not€intend€to€establish€the€standard€of€care€when€they€prepareÐ ˜Ø Ða€drugððs€labeling€or€PDR€reference.€€These€materials€are€intended€to€comply€with€the€FDAððsÐ „Ä Ðregulations,€to€provide€advertising€and€promotional€material,€and€to€limit€the€manufacturerððs€liability.€Ð p° ÐòòSee€Thompson€v.€Carteróó,€518€So.€2d€at€612„13;€òòMorlino€v.€Medical€Ctr.óó,€706€A.2d€at€729;€òòSpensieriÐ \œ Ðv.€Laskyóó,€723€N.E.2d€at€549;€òòRamon€v.€Farróó,€770€P.2d€at€135„36;€Bird,€44€U.€Chi.€L.€Rev.€at€424.€Ð H ˆ ÐFinally,€the€labeling€and€PDR€reference€cannot€be€cross„examined.€€òòSee€Spensieri€v.€Laskyóó,€723Ð 4 t ÐN.E.2d€at€548.Ð  ` ÐÌà  àWe€adopt€the€majority€approach€regarding€the€introduction€and€evidentiary€weight€to€beÐ ø 8  Ðgiven€to€FDA„approved€drug€labeling€and€the€parallel€PDR€reference.€€Neither€of€these€materials,Ð ä $  Ðby€themselves,€are€prima€facie€evidence€of€the€prescribing€physicianððs€standard€of€care.€€Thus,€proofÐ Ð  Ðof€a€departure€from€the€recommendations€in€a€drugððs€labeling€or€PDR€reference€is€not€aloneÐ ¼ü  Ðsufficient€to€prove€a€breach€of€the€standard€of€care.€€However,€the€labeling€and€the€PDR€referenceÐ ¨è  Ðcan€provide€significant€assistance€in€identifying€the€standard€of€care.€€Accordingly,€we€find€that€aÐ ”Ô  Ðprescription€drugððs€labeling€or€its€PDR€reference,€when€introduced€along€with€other€expert€evidenceÐ €À Ðon€the€standard€of€care,€is€admissible€to€assist€the€trier„of„fact€to€determine€whether€the€drugÐ l¬ Ðpresented€an€unacceptable€risk€to€the€patient.€€Ð X˜ ÐÌà@‹‹)ìàò òD.ó óˆÐ 0p Ðà@É É ìàòòò òThe€Use€of€Adrenergic€Drugs€for€Tocolysisó óóóˆÐ \ ÐÌà  àAt€trial,€the€Richardsons€claimed€that€Dr.€Miller€violated€the€standard€of€care€ò òó óby€continuingÐ ô4 ÐMs.€Richardson€on€terbutaline€after€she€complained€of€severe€chest€pains,€and€by€deciding€toÐ à  Ðadminister€terbutaline€to€Ms.€Richardson€subcutaneously€using€an€infusion€pump.€€A€survey€of€theÐ Ì  Ðevidence€and€other€information€about€the€off„label€use€of€drugs€like€terbutaline€for€tocolysis€providesÐ ¸ø Ða€helpful€framework€for€determining€whether€the€trial€court€properly€excluded€the€evidence€regardingÐ ¤ä Ðthe€off„label€use€of€terbutaline€for€tocolysis€in€light€of€the€Richardsonsðð€claims.€€This€informationÐ Ð Ðindicates€that€the€safety€and€efficacy€of€terbutaline€administered€with€an€infusion€pump€for€tocolysisÐ |¼ Ðwas€being€debated€when€it€was€administered€to€Ms.€Richardson€and€continues€to€be€debated€today.Ð h¨ ÐÌà  àIn€the€early€1970's,€the€FDA€approved€the€use€of€a€beta„adrenergic€drug€called€ritodrineÐ @!€  Ðhydrochloride€(ð ðritodrineðð)€for€use€in€tocolysis.€€This€drug,€which€could€be€administered€orally,Ð ,"l! Ðintravenously,€or€intramuscularly,€was€a€smooth€muscle€relaxer€that€helped€relax€uterine€contractionsÐ #X" Ðthus€buying€more€time€for€babies€to€develop€in€their€motherððs€womb€before€being€delivered.€€AtÐ $D # Ðapproximately€the€same€time,€a€Swedish€manufacturer€named€Astra€Pharmaceuticals€(ð ðAstraðð)Ð ð$0!$ Ðdeveloped€another€beta„adrenergic€drug,€terbutaline,€principally€as€a€bronchodilator€to€relax€and€openÐ Ü%"% Ðthe€constricted€airways€of€persons€suffering€from€asthma.€€After€obtaining€the€FDAððs€approval€toÐ È&#& Ðmarket€terbutaline€as€an€asthma€medication,€Astra€manufactured€and€sold€the€drug€under€the€tradeÐ ´'ô#' Ðname€ð ðBricanyl.ðð€€Thereafter,€Astra€licensed€Ciba„Geigy€to€manufacture€and€market€terbutaline.€Ð  (à$( ÐCiba„Geigy€began€selling€terbutaline€under€the€trade€name€ð ðBrethineðð€using€the€same€labeling€thatÐ Œ)Ì%) Ðthe€FDA€had€approved€for€Bricanyl.Ð x*¸&* Ðâ âÐ d+¤'+ Ðà  àIn€the€mid„1970's,€physicians€began€to€discover€that€terbutaline,€administered€intravenously,Ð À Ðâ âhad€tocolytic€effects€similar€to€those€of€ritodrine.€€òòSeeóó€Fung€Lam,€et€al.,€òòClinical€Issues€SurroundingÐ ¬ì Ðthe€Use€of€Terbutaline€Sulfate€for€Preterm€Laboróó,€53€Obstet.€&€Gyn.€Survey€S85,€S86€(Supp.€1998)Ð ˜Ø Ð(ð ðLamðð).€€However,€in€1980€or€1981,€Astra€amended€the€FDA„approved€labeling€for€Bricanyl€toÐ „Ä Ðwarn€against€the€intramuscular€use€of€terbutaline€for€tocolysis€after€it€received€reports€of€adverseÐ p° Ðreactions€to€the€drug€when€it€was€used€for€that€purpose.€€After€the€FDA€approved€Astraððs€changesÐ \œ Ðto€Bricanylððs€labeling,€Ciba„Geigy€added€the€same€warning€to€the€Brethineððs€labeling.׃0×Ý ƒ #ÃÝòòÚ  Ú21Ú  ÚóóÝ  Ý×  ×€€In€1983,Ð H ˆ Ðboth€Astra€and€Ciba„Geigy€added€the€same€warnings€and€precautions€to€their€terbutaline€tablets.Ð 4 t ÐÌà  àDespite€the€warnings€in€the€drugððs€labeling€regarding€the€use€of€terbutaline€for€tocolysis,€theÐ  L  Ðdrug€found€increasing€favor€with€physicians€around€the€country€as€an€appropriate€way€to€prolongÐ ø 8  Ðpremature€labor.€€The€typical€course€of€treatment,€albeit€off„label,€involved€administering€terbutalineÐ ä $  Ðintramuscularly€while€the€patient€was€hospitalized€and€then€switching€to€oral€medication€if€the€drugÐ Ð  Ðhad€the€effect€of€slowing€down€the€patientððs€labor.׃:À ×Ý ƒ #ÃÝòòÚ  Ú22Ú  ÚóóÝ  Ý×  ×€€In€1986,€a€San€Francisco€physician€beganÐ ¼ü  Ðexperimenting€with€an€infusion€pump€to€administer€terbutaline€on€an€out„patient€basis€withoutÐ ¨è  Ðrequiring€hospitalization.€€òòSeeóó€Lam,€53€Obstet.€&€Gyn.€Survey€at€S86„S87.€€In€1988,€the€physicianÐ ”Ô  Ðreported€that€his€ð ðSubcutaneous€Terbutaline€Pump€Therapyðð€(ð ðSQTPðð)€produced€dramatic€tocolyticÐ €À Ðeffects€at€a€greatly€reduced€dosage€level.€€These€reports€prompted€various€infusion€pumpÐ l¬ Ðmanufacturers€and€others€to€begin€heavily€promoting€SQTP€therapy.Ð X˜ ÐÌà  àIn€October€1992,€the€FDAððs€Fertility€and€Maternal€Health€Drugs€Advisory€CommitteeÐ 0p Ðconcluded€that€oral€ritodrine€maintenance€therapy€had€no€place€in€obstetric€practice€because€of€itsÐ \ Ðlack€of€efficacy€in€the€presence€of€its€known€toxicity.׃2 ×Ý ƒ #ÃÝòòÚ  Ú23Ú  ÚóóÝ  Ý×  ×€€Accordingly,€the€FDA€advised€ritodrineððsÐ H Ðmanufacturer€to€perform€more€studies€to€validate€the€drugððs€efficacy.€€Rather€then€taking€on€thisÐ ô4 Ðfinancial€burden,€the€manufacturer€simply€withdrew€oral€ritodrine€for€maintenance€tocolysis€fromÐ à  Ðthe€United€States€market.€€òòSeeóó€Lam,€53€Obstet.€&€Gyn.€Survey€at€S91.€€As€a€result€of€this€decision,Ð Ì  Ðterbutaline€became€the€most€commonly€used€beta„adrenergic€drug€for€tocolysis,€despite€theÐ ¸ø Ðmanufacturerððs€warnings.€€Ð ¤ä Їà  àIn€May€1993,€the€FDAððs€Fertility€and€Maternal€Health€Drugs€Advisory€Committee€concludedÐ À Ðthat€ð ðterbutaline€administered€intravenously€appeared€to€have€an€acceptable€risk„benefit€profile€forÐ ¬ì Ðthe€acute€treatment€of€preterm€labor€under€limited€circumstances€(i.e.,€in€pregnancies€of€33€weeksÐ ˜Ø Ðor€less,€when€cervical€dilation€is€4€centimeters€or€less€and€there€is€no€premature€rupture€of€theÐ „Ä Ðmembranes,€and€with€careful€maternal€and€fetal€monitoring.ðð€€Woodcock€Letter,€òòsupraóó€note€23,€atÐ p° Ð2€(citing€Transcript€of€Fertility€and€Maternal€Health€Drugs€Advisory€Committee€meeting,€May€21,Ð \œ Ð1993,€at€181„83);€òòsee€alsoóó€Lam,€53€Obstet.€&€Gyn.€Survey€at€S92.€€After€concluding€that€terbutalineÐ H ˆ Ðmay€be€effective€in€preventing€preterm€labor€for€a€brief€period€of€forty„eight€to€seventy„two€hoursÐ 4 t Ðbut€that€evidence€of€its€long„term€effectiveness€was€lacking,€the€FDA€invited€supplemental€new€drugÐ  ` Ðapplications€requesting€approval€to€use€terbutaline€for€tocolysis.€€The€FDA€also€encouraged€theÐ  L  Ðmanufacturers€to€review€their€labeling€to€address€the€need€for€clarification€of€the€uses€and€risks€ofÐ ø 8  Ðterbutaline.€€òòSeeóó€Woodcock€Letter,€òòsupraóó€note€23,€at€2„3,€9.€€Despite€the€FDAððs€invitation,Ð ä $  Ðterbutalineððs€manufacturers€did€not€request€approval€to€use€the€drug€for€tocolysis€and€did€not€requestÐ Ð  Ðchanges€in€the€drugððs€labeling.Ð ¼ü  ÐÌà  àThe€debate€surrounding€the€safety€and€efficacy€of€terbutaline€as€a€tocolytic€agent€hasÐ ”Ô  Ðcontinued€since€Ms.€Richardsonððs€injury.€€In€June€1995,€the€American€College€of€Obstetricians€andÐ €À ÐGynecologists€(ð ðACOGðð)€issued€a€technical€bulletin€regarding€preterm€labor.׃3×Ý ƒ #ÃÝòòÚ  Ú24Ú  ÚóóÝ  Ý×  ×€€While€noting€thatÐ l¬ Ðtocolytic€agents€are€commonly€used,€the€bulletin€pointed€out€that€ð ðno€studies€have€convincinglyÐ X˜ Ðdemonstrated€an€improvement€in€survival€or€any€index€of€long„term€neonatal€outcome€with€the€useÐ D„ Ðof€tocolytic€therapy.€€On€the€other€hand,€the€potential€damages€of€tocolytic€therapy€to€the€mother€andÐ 0p Ðthe€neonate€is€well€documented.ðð׃4Ü×Ý ƒ #ÃÝòòÚ  Ú25Ú  ÚóóÝ  Ý×  ×€With€specific€regard€to€SQTP€therapy,€the€bulletin€noted€thatÐ \ Ðð ðthere€is€no€evidence€to€support€the€efficacy€of€this€costly€and€complicated€approach.ðð׃;h×Ý ƒ #ÃÝòòÚ  Ú26Ú  ÚóóÝ  Ý×  ×€€The€bulletinÐ H Ðalso€observed€that€ð ð[e]ach€case€must€be€judged€individually€by€weighing€the€risks€of€continuing€theÐ ô4 Ðpregnancy€versus€those€of€deliveryðð€and€that€ð ðmost€clinicians€begin€treatment€prior€to€34€weeks€ofÐ à  Ðgestation€but€approach€the€management€of€preterm€labor€at€34„37€weeks€on€an€individualizedÐ Ì  Ðbasis.ðð׃=ô×Ý ƒ #ÃÝòòÚ  Ú27Ú  ÚóóÝ  Ý×  ×€€Accordingly,€ACOG€concluded€that€ð ð[a]lthough€different€forms€of€therapy€.€.€.€are€beingÐ ¸ø Ðused€to€prevent€prematurity,€their€true€benefit€and€the€proper€place€for€their€application€remain€to€beÐ ¤ä Ðestablished.ðð׃>€×Ý ƒ #ÃÝòòÚ  Ú28Ú  ÚóóÝ  Ý×  ×Ð Ð ÐÌà  àIn€1996,€the€National€Womenððs€Health€Network€petitioned€the€FDA€to€review€theÐ h¨ Ðsubcutaneous€administration€of€terbutaline€using€an€infusion€pump.׃B ×Ý ƒ #ÃÝòòÚ  Ú29Ú  ÚóóÝ  Ý×  ×€€On€November€13,€1997,€theÐ T ” ÐFDAððs€Associate€Commissioner€for€Health€Affairs€issued€a€ð ðDear€Colleagueðð€letter€to€the€medicalÐ @!€  Ðcommunity€warning€physicians€about€the€continuous€subcutaneous€administration€of€terbutaline.Ô_Ô׃@×Ý ƒ #ÃÝòòÚ  Ú30Ú  ÚóóÝ  Ý×  ×Ô_ԀРÀ ÐNoting€the€FDAððs€concern€over€the€ð ðpromotion€and€increasingly€widespread€use€of€subcutaneousÐ ¬ì Ðterbutaline€delivered€by€infusion€pump€for€the€treatment/prevention€of€preterm€labor,ðð€the€letterÐ ˜Ø Ðstated€that€ð ðit€is€clear€that€the€demonstrated€value€of€tocolytics€in€general€is€limited€to€an€initial,€briefÐ „Ä Ðperiod€of€treatment,€probably€no€more€than€48„72€hoursðð€and€that€ð ð[n]o€benefit€from€prolongedÐ p° Ðtreatment€has€been€documented.ðð€€Thus,€the€FDA€letter€alerted€ð ðpractitioners,€home€health€careÐ \œ Ðagencies,€insurance€carriers,€and€others€that€continuous€subcutaneous€administration€of€terbutalineÐ H ˆ Ðsulfate€has€not€been€demonstrated€to€be€effective€and€is€potentially€dangerous.ðð€€In€April€1998,€theÐ 4 t ÐTerbutaline€Strategy€Group,€a€coalition€of€researchers€and€practicing€physicians,€requested€the€FDAÐ  ` Ðto€reevaluate€its€position€regarding€the€use€of€terbutaline€by€subcutaneous€infusion.€€However,€onÐ  L  ÐOctober€19,€1999,€the€FDA€reaffirmed€its€concerns€regarding€the€ð ðprolonged,€at„home€use€ofÐ ø 8  Ðsubcutaneous€terbutalineðð€and€declined€to€withdraw€the€November€13,€1997€ð ðDear€Colleagueðð€letterÐ ä $  Ðor€to€require€the€manufacturers€of€terbutaline€to€remove€the€warnings€in€the€drugððs€labeling€againstÐ Ð  Ðits€use€for€the€management€of€preterm€labor€or€to€submit€a€new€drug€application€for€approval€ofÐ ¼ü  Ðterbutaline€as€a€tocolytic€agent.€€òòSeeóó€Woodcock€Letter,€òòsupraóó€note€23,€at€9„12.Ð ¨è  ÐÌà@)ìàò òE.ó óˆÐ €À Ðà@eeìàòòò òAdmissibility€of€The€Richardsonsðð€Evidence€That€the€Use€of€TerbutalineˆÐ l¬ Ðà@ççìàFor€Tocolysis€is€Off„Labeló óóóˆÐ X˜ ÐÌà  àWhile€the€practice€of€using€drugs€off„label€is€widespread€and€not€inherently€inappropriate,Ð 0p Ðthere€are€well„documented€instances€where€an€accepted€and€popular€off„label€use€of€a€drug€hasÐ \ Ðultimately€proved€to€be€harmful.€òò€Seeóó€Beck€&€Azari,€53€Food€&€Drug€L.J.€at€71„72;€Smith,€34€WakeÐ H ÐForest€L.€Rev.€at€971.׃8×Ý ƒ #ÃÝòòÚ  Ú31Ú  ÚóóÝ  Ý×  ×€€Physicians€may€be€found€negligent€if€their€decision€to€use€a€drug€off„labelÐ ô4 Ðis€sufficiently€careless,€imprudent,€or€unprofessional.€€The€Richardsonsðð€causes€of€action€against€Dr.Ð à  ÐMiller€and€Tokos€are€not€based€simply€on€the€fact€that€tocolysis€is€an€off„label€use€of€terbutaline.׃Að×Ý ƒ #ÃÝòòÚ  Ú32Ú  ÚóóÝ  Ý×  ×€Ð Ì  ÐRather,€their€negligence€claim€rests€on€the€following€two€theories:(1)€Dr.€Miller€should€haveÐ ¸ø Ðdiscontinued€administering€terbutaline€for€tocolysis€when€she€began€experiencing€chest€painÐ ¤ä Ðfollowing€the€second€oral€dose€and€(2)€Dr.€Miller€should€not€have€ordered,€and€Tokos€should€notÐ Ð Ðhave€provided,€the€subcutaneous€administration€of€terbutaline€using€an€infusion€pump€because€theÐ |¼ Ðeffect€of€using€the€pump€was€to€maintain€or€even€increase,€rather€than€decrease,€the€level€ofÐ h¨ Ðterbutaline€in€her€system.Ð T ” ÐÌà  àThe€Richardsons€did€not€intend€to€limit€their€evidence€regarding€the€applicable€standard€ofÐ ,"l! Ðcare€solely€to€terbutalineððs€FDA„approved€labeling€or€the€parallel€PDR€reference.€€They€also€intendedÐ #X" Ðto€call€Drs.€Glen€Farr,€Mario€Gaudino,€Ronald€Krone,€and€James€Dingfelder€to€provide€expertÐ À Ðopinions€on€this€issue.€€Dr.€Gaudino,€representing€terbutalineððs€manufacturer,€would€have€(1)Ð ¬ì Ðauthenticated€the€drugððs€FDA„approved€labeling,€(2)€testified€regarding€the€origin€of€theÐ ˜Ø Ðmanufacturerððs€warnings€and€precautions€against€using€terbutaline€for€tocolysis,€and€(3)€confirmedÐ „Ä Ðthat€the€labeling€contained€no€instructions€regarding€the€dosage€or€method€of€administeringÐ p° Ðterbutaline€when€used€for€tocolysis.€€Dr.€Farr,€a€pharmacologist,€was€prepared€to€testify€that€theÐ \œ Ðabsence€of€dosage€or€administration€directions€in€terbutalineððs€labeling€would€have€requiredÐ H ˆ Ðphysicians€to€rely€on€individual€policies€and€standards€for€administering€or€prescribing€terbutalineÐ 4 t Ðto€retard€preterm€labor.€€This€testimony,€when€coupled€with€Dr.€Dingfelderððs€testimony€that€Dr.Ð  ` ÐMiller€should€not€have€continued€Ms.€Richardson€on€terbutaline€after€she€began€experiencing€chestÐ  L  Ðpain€would€have€been€sufficient€to€require€Dr.€Miller€to€explain€why€he€continued€administeringÐ ø 8  Ðterbutaline€after€Ms.€Richardson€began€experiencing€severe€chest€pains,€as€well€as€the€basis€for€hisÐ ä $  Ðdecision€to€use€an€infusion€pump€and€how€the€proper€dosage€was€determined.׃G×Ý ƒ #ÃÝòòÚ  Ú33Ú  ÚóóÝ  Ý×  ×Ð Ð  ÐÌà  àDecisions€regarding€the€admissibility€of€evidence€address€themselves€to€the€trial€courtððsÐ ¨è  Ðdiscretion,€òòSee€Seffernick€v.€Saint€Thomas€Hosp.óó,€969€S.W.2d€391,€393€(Tenn.€1998);€òòDockery€v.Ð ”Ô  ÐBoard€of€Profððl€Responsibilityóó,€937€S.W.2d€863,€866€(Tenn.€1996).€While€the€trial€courts€have€wideÐ €À Ðlatitude€in€making€these€decisions,€òòsee€Overstreet€v.€Shoneyððs,€Inc.óó,€4€S.W.3d€694,€702€(Tenn.€Ct.Ð l¬ ÐApp.€1999),€they€must€take€into€consideration€the€factual€circumstances€and€the€relevant€legalÐ X˜ Ðprinciples.€€òòSee€State€v.€Shuckóó,€953€S.W.2d€662,€669€(Tenn.€1997).€€Accordingly,€appellate€courtsÐ D„ Ðwill€not€overturn€a€trial€courtððs€evidentiary€ruling€unless€the€trial€court€applied€an€incorrect€legalÐ 0p Ðstandard,€based€its€decision€on€a€clearly€erroneous€view€of€the€evidence,€or€has€reached€a€decisionÐ \ Ðagainst€logic€and€reason€that€caused€injustice€to€the€complaining€party.€€òòSee€State€v.€Shuckóó,€953Ð H ÐS.W.2d€at€669;€òòBallard€v.€Herzkeóó,€924€S.W.2d€652,€661€(Tenn.€1996);€òòOverstreet€v.€Shoneyððs,€Inc.óó,Ð ô4 Ð4€S.W.3d€at€708.Ð à  ÐÌà  àTenn.€R.€Evid.€402€reflects€the€policy€that€all€evidence€meeting€Tenn.€R.€Evid.€401's€test€ofÐ ¸ø Ðrelevancy€is€admissible€unless€otherwise€excluded€on€constitutional€or€statutory€grounds€or€by€virtueÐ ¤ä Ðof€other€provisions€in€the€rules€themselves.€€òòSee€Phillips€v.€F.W.€Woolworth€Co.óó,€867€S.W.2d€316,Ð Ð Ð318€(Tenn.€Ct.€App.€1992).€€Tenn.€R.€Evid.€403€provides€one€such€exception€to€the€general€principlesÐ |¼ Ðof€admissibility.€€It€authorizes€the€trial€court€to€exclude€otherwise€relevant€evidence€if€its€probativeÐ h¨ Ðvalue€is€outweighed€by€the€danger€of€unfair€prejudice,€confusion,€misleading€the€jury,€or€unnecessaryÐ T ” Ðdelay.€€The€language€of€Tenn.€R.€Evid.€403€strongly€suggests€that€relevant€evidence€should€beÐ @!€  Ðadmitted€if€the€balance€between€the€probative€value€of€the€evidence€and€its€prejudicial€effect€is€close.€Ð ,"l! ÐòòSeeóó€Neil€P.€Cohen,€et€al.,€òòTennessee€Law€of€Evidenceóó€ðð€403.3,€at€152€(3d€ed.€1995)€Ô_Ô(ð ðTennesseeÔ_Ô€LawÐ #X" Ðâ âof€Evidenceðð).€Thus,€excluding€otherwise€relevant€evidence€under€Tenn.€R.€Evid.€403€is€anÐ $D # Ðextraordinary€step€that€should€be€used€sparingly.€€òòSee€White€v.€Vanderbilt€Univ.óó,€___€S.W.3d€___,Ð À Ð___€(Tenn.€Ct.€App.€1999).׃P×Ý ƒ #ÃÝòòÚ  Ú34Ú  ÚóóÝ  Ý×  ×Ð ¬ì Ðâ âÌà  àAs€we€have€recently€pointed€out,€a€trial€courtððs€application€of€Tenn.€R.€Evid.€403€shouldÐ „Ä Ðproceed€in€two€steps.€€The€first€step€requires€the€trial€court€to€balance€the€probative€value€of€theÐ p° Ðevidence€sought€to€be€excluded€against€the€combined€weight€of€the€countervailing€factors€in€Tenn.Ð \œ ÐR.€Evid.€403.€€If€the€court€determines€that€the€countervailing€factors€do€not€outweigh€the€probativeÐ H ˆ Ðvalue€of€the€evidence,€the€trial€court€should€proceed€no€further€and€should€deny€the€motion€toÐ 4 t Ðexclude€the€evidence€under€Tenn.€R.€Evid.€403.€€If,€however,€the€court€determines€that€theÐ  ` Ðcountervailing€factors€outweigh€the€probative€value€of€the€evidence,€it€should€proceed€to€the€secondÐ  L  Ðstep€in€which€the€court€exercises€its€discretion€to€decide€whether€the€evidence€should€be€excludedÐ ø 8  Ðnotwithstanding€its€relevancy.€€òòSee€White€v.€Vanderbilt€Univ.óó,€___€S.W.3d€at€___.׃J×Ý ƒ #ÃÝòòÚ  Ú35Ú  ÚóóÝ  Ý×  ×Ð ä $  ÐÌà  àWe€have€determined€that€the€trial€court€misapplied€Tenn.€R.€Evid.€403€in€this€case.€€TheÐ ¼ü  Ðevidence€regarding€terbutalineððs€off„label€usage€is€particularly€relevant€with€regard€to€Dr.€MillerððsÐ ¨è  Ðdecision€to€continue€Ms.€Richardson€on€terbutaline€after€she€experienced€chest€pain,€as€well€as€hisÐ ”Ô  Ðdecisions€regarding€the€method€of€administration€and€the€proper€dosage.€€In€light€of€the€absence€ofÐ €À Ðthe€manufacturerððs€instructions€regarding€recommended€dosage€levels€and€methods€ofÐ l¬ Ðadministration,€pinpointing€the€basis€for€Dr.€Millerððs€decisions€regarding€the€use€of€the€drug€isÐ X˜ Ðintegrally€related€to€the€Richardsonsðð€claim€that€Dr.€Miller€should€not€have€continued€Ms.Ð D„ ÐRichardson€on€tocolysis€using€terbutaline€after€she€experienced€chest€pain.Ð 0p ÐÌà  àIn€comparison,€there€is€very€little€basis€in€the€record€to€support€the€conclusion€that€permittingÐ H Ðthe€Richardsons€to€introduce€this€evidence€or€to€cross„examine€the€defendants€and€their€expertsÐ ô4 Ðbased€on€this€evidence€would€have€produced€any€of€the€countervailing€factors€included€in€Tenn.€R.Ð à  ÐEvid.€403.€€There€is€no€arguable€claim€that€permitting€the€Richardsons€to€use€this€evidence€wouldÐ Ì  Ðhave€resulted€in€undue€delay,€waste€of€time,€or€the€needless€presentation€of€cumulative€evidence.€Ð ¸ø ÐThe€only€colorable€grounds€for€excluding€the€evidence€are€unfair€prejudice,€confusion€of€the€issues,Ð ¤ä Ðor€misleading€the€jury.€€We€perceive€no€real€danger€of€unfair€prejudice€because€this€evidence€willÐ Ð Ðnot€prompt€the€jury€to€decide€the€case€based€on€improper€considerations€such€as€bias,€sympathy,Ð |¼ Ðhatred,€contempt,€retribution,€or€horror.€€òòSee€Buddy€Lee€Attractions,€Inc.€v.€William€Morris€Agency,Ð h¨ ÐInc.óó,€13€S.W.3d€343,€352€(Tenn.€Ct.€App.€1999);€òòState€v.€Collinsóó,€986€S.W.2d€13,€20€(Tenn.€Crim.Ð T ” ÐApp.€1998).Ð @!€  ÐÌà  àLikewise,€we€find€little€basis€for€concern€that€permitting€the€Richardsons€to€use€the€evidenceÐ #X" Ðthat€tocolysis€is€an€off„label€use€of€terbutaline€will€confuse€the€issues€or€mislead€the€jury.€€SuchÐ $D # Ðarguments€assume€that€lay€persons€will€be€unable€to€understand€that€prescribing€a€prescription€drugÐ ð$0!$ Ðfor€an€off„label€use€is€not€necessarily€negligent.€€State€and€federal€courts€around€the€country€haveÐ Ü%"% Ðdealt€with€this€very€sort€of€evidence€without€becoming€bogged€down€with€the€sorts€of€problems€Dr.Ð È&#& ÐMiller€and€Tokos€imagine.€€The€Richardsons€may€very€well€want€the€jury€to€believe€that€Dr.€MillerÐ ´'ô#' Ðshould€not€have€continued€Ms.€Richardson€on€terbutaline.€€However,€if€Dr.€Millerððs€actions€wereÐ À Ðconsistent€with€the€applicable€standard€of€care,€we€have€no€doubt€that€he€will€be€able€to€presentÐ ¬ì Ðcompetent€expert€evidence€to€support€the€propriety€of€his€actions.€€Vigorous€cross„examination,€theÐ ˜Ø Ðpresentation€of€contrary€evidence,€and€proper€instructions€will€head€off€any€possibility€that€the€juryÐ „Ä Ðwill€be€confused€or€misled€regarding€the€significance€of€the€regulatory€status€of€terbutaline.Ð p° ÐÌà  àFurthermore,€we€do€not€find€that€the€status€of€terbutalineððs€FDA„approved€labeling€isÐ H ˆ Ðmisleading.€€Standing€alone,€it€does€not€establish€the€standard€of€care.€€The€trial€court€will€no€doubtÐ 4 t Ðmake€this€clear€to€the€jury€in€its€instructions.€€In€this€case,€the€fact€that€terbutaline€was€put€to€an€off„Ð  ` Ðlabel€use€is€simply€one€piece€of€information€along€with€everything€else€for€the€fact„finders€to€sort€outÐ  L  Ðand€consider.€€Based€on€these€considerations,€we€find€that€the€possible€prejudice€to€the€defendantsÐ ø 8  Ðstemming€from€the€admission€of€the€evidence€regarding€the€off„label€use€of€terbutaline€for€tocolysisÐ ä $  Ðdoes€not€outweigh€the€probative€value€of€the€evidence.€€Accordingly,€the€trial€court€had€no€basis€forÐ Ð  Ðexercising€its€discretion€to€exclude€this€evidence€or€to€prevent€the€Richardsons€from€cross„examiningÐ ¼ü  Ðthe€defendants€and€their€experts€based€on€this€evidence.€€We€also€find€that€the€trial€courtððs€decisionÐ ¨è  Ðto€exclude€this€evidence€materially€hampered€the€Richardsonsðð€ability€to€prove€their€medicalÐ ”Ô  Ðmalpractice€claims€and,€more€probably€than€not,€affected€the€outcome€of€the€trial.Ð €À ÐÌà  àWe€find,€therefore,€that€the€trial€court€erred€by€granting€Dr.€Millerððs€motions€to€exclude€theÐ X˜ Ðevidence€regarding€terbutalineððs€off„label€use,€including€its€labeling€and€the€parallel€PDR€referenceÐ D„ Ðand€Dr.€Gaudinoððs€testimony,€as€well€as€that€of€the€Richardsonsðð€other€medical€experts.€€The€juryÐ 0p Ðwas€entitled€to€consider€this€evidence€along€with€the€opinions€of€Ms.€Richardsonððs€experts€that€Dr.Ð \ ÐMiller€breached€the€standard€of€care€by€continuing€to€prescribe€terbutaline€as€a€tocolytic€agent€afterÐ H ÐMs.€Richardson€complained€of€cardiac„related€symptoms.€€Accordingly,€the€appropriate€remedy€isÐ ô4 Ðto€vacate€the€verdict€and€remand€the€case€for€a€new€trial.Ð à  ÐÌà@……)ìàò òII.ó óˆÐ ¸ø Ðà@— — ìàòòò òThe€Tokos€„€Related€Evidentiary€Issuesó óóóˆÐ ¤ä ÐÌà  àThe€Richardsons€raise€two€other€evidentiary€issues€regarding€Tokos.€€First,€they€assert€thatÐ |¼ Ðthe€trial€court€erred€by€preventing€them€from€introducing€Tokosððs€policy€strongly€suggesting€an€EKGÐ h¨ Ðbefore€beginning€terbutaline€infusion€therapy.€€Second,€they€take€issue€with€the€trial€courtððs€refusalÐ T ” Ðto€permit€them€to€prove€that€Tokos€did€not€have€a€license,€permit,€or€certificate€of€need€to€operateÐ @!€  Ðin€Tennessee.€€We€need€not€dwell€long€on€either€of€these€issues;€however,€we€are€addressing€themÐ ,"l! Ðbecause€the€issues€will€likely€reoccur€should€this€case€be€tried€again.Ð #X" ÐÌà@‹‹)ìàò òA.ó óˆÐ ð$0!$ Ðòòò òà@  ìàThe€Tokos€Policy€Regarding€An€EKGó óóóˆÐ Ü%"% ÐÌà  àThe€Richardsons€assert€that€the€trial€court€ð ðshould€have€allowed€plaintiffs€to€introduce€theÐ ´'ô#' ÐTokos€policy€regarding€[the]€requirement€of€an€EKG€and€should€have€permitted€the€plaintiffs€toÐ  (à$( Ðcross„examine€defendants€about€their€failure€to€follow€their€own€protocols.ðð€€This€argument€isÐ Œ)Ì%) Ðsomewhat€puzzling.€€Although€the€record€on€this€point€leaves€much€to€be€desired,€it€appears€that€theÐ x*¸&* Ðâ âtrial€court€permitted€the€Richardsons€to€make€their€point€that€Dr.€Miller€did€not€order,€and€the€TokosÐ d+¤'+ Ðrepresentatives€did€not€suggest€or€request,€an€EKG€immediately€before€beginning€the€infusion€pumpÐ À Ðeven€though€the€Tokos€protocols€recommended€one.Ð ¬ì Ðâ âÌà  àThe€parties€had€several€skirmishes€both€before€and€during€trial€regarding€the€Tokos€policyÐ „Ä Ðrequiring€an€EKG€before€starting€tocolysis€using€an€infusion€pump.€€The€Richardsons€asserted€thatÐ p° ÐTokos€violated€its€own€policy€by€not€insisting€on€an€EKG,€and€they€were€prepared€to€introduce€theÐ \œ Ðpolicy€and€to€prove€that€no€Tokos€employee€requested€or€suggested€an€EKG€before€starting€theÐ H ˆ Ðpump.€€For€their€part,€Dr.€Miller€and€Tokos€argued€that€the€policy€was€irrelevant,€first€because€theÐ 4 t Ðfailure€to€administer€an€EKG€prior€to€using€the€infusion€pump€did€not€cause€Ms.€RichardsonððsÐ  ` Ðinjuries,€and€second€because€the€Tokos€policy€did€not€apply€while€Ms.€Richardson€wasÐ  L  Ðhospitalized.׃×Ý ƒ #ÃÝòòÚ  Ú36Ú  ÚóóÝ  Ý×  ×€€Ð ø 8  ÐÌà  àBefore€empaneling€the€jury,€the€trial€court€held€that€evidence€regarding€the€policy€wasÐ Ð  Ðadmissible€as€a€factual€matter€but€not€on€the€issue€of€causation.׃d×Ý ƒ #ÃÝòòÚ  Ú37Ú  ÚóóÝ  Ý×  ×€€Based€on€that€ruling,€theÐ ¼ü  ÐRichardsons€introduced€portions€of€the€deposition€of€Bev€Palmer,€Tokosððs€zone€pharmacy€manager.€Ð ¨è  ÐMs.€Palmer€discussed€two€Tokos€policies€during€the€portions€of€her€deposition€that€were€read€to€theÐ ”Ô  Ðjury.€€First,€she€acknowledged€that€PBH„00322€required€the€Tokos€clinical€staff€ð ðto€confirmÐ €À Ðphysicianððs€orders€for€an€EKG€as€part€of€the€guidelines€for€initiation€of€tocolytic€infusion€therapyÐ l¬ Ðfor€a€patient.ðð׃M< ×Ý ƒ #ÃÝòòÚ  Ú38Ú  ÚóóÝ  Ý×  ×€€Second,€she€referred€to€a€portion€of€PBH„00304€stating€that€ð ð[i]t€is€stronglyÐ X˜ Ðrecommended€that€patients€have€a€recent€EKG€and€appropriate€lab€work€.€.€..ðð€€The€trial€courtÐ D„ Ðdirected€that€PBH„00304€be€admitted€and€marked€as€Exhibit€3.×ƒÈ ×Ý ƒ #ÃÝòòÚ  Ú39Ú  ÚóóÝ  Ý×  ×€€In€addition,€the€following€threeÐ 0p Ðquestions€and€Ms.€Palmerððs€answers€were€read€to€the€jury:Ð \ ÐÌà8  àà8` Ð Ð àà ¸ àQUESTION:à h àWell,€do€you€know€whether€it€was€a€policy€ofÐ ô4 ÐTokos€Medical€Corporation€for€the€Tokos€clinical€staff€to€confirmÐ à  Ðthat€a€physician€had€ordered€an€EKG?ÐÌ ` x` x Їà  àà ` àà ¸ àà  àà h à*à0 À à*à0À(#À(#à*ÐÀ(#(# ÐÌà8  àà8` Ð Ð àà ¸ àANSWER:à h àThe€note.€€It€is€strongly€recommended€thatÐ ˜Ø Ðpatients€have€a€recent€EKG€and€appropriate€lab€work,€et€cetera,€etÐ „Ä Ðcetera,€et€cetera.€€So€to€me€the€policy€is€that€an€EKG€„€„€it€is€stronglyÐ p° Ðrecommended€that€patients€have€a€recent€EKG.Ð\œ` x` x ÐÌà  àà ` àà ¸ àà  àà h à*à0 À à*à0À(#À(#à*Ð4 t(#(# ÐÌà8  àà8` Ð Ð àà ¸ àQUESTION:à h àIððm€asking€you,€from€your€understanding€ofÐ  L  Ðresponsibilities€of€an€area€clinical€pharmacist€in€June€of€ðð93,€wouldÐ ø 8  Ðthe€area€clinical€pharmacist€under€Tokos€policies€and€procedures€inÐ ä $  ÐJune€of€ðð93€have€a€responsibility€to€confirm€that€an€EKG€had€beenÐ Ð  Ðconducted€prior€to€the€initiation€of€a€patientððs€tocolytic€infusionÐ ¼ü  Ðtherapy?Шè ` x` x ÐÌà  àà ` àà ¸ àANSWER:à0 h àI€believe€so.ЀÀh(#h(# ÐÌà  àà ` àà ¸ àà  àà h à*à0 À à*à0À(#À(#à*ÐX˜(#(# ÐÌà  àà8 ` àà ¸ àQUESTION:à h àYou€do€believe€it€was€a€policy€for€the€TokosÐ 0p Ðnurse€to€converse€with€the€physician€in€June€of€ðð93€prior€to€initiationÐ \ Ðof€tocolytic€infusion€therapy?ÐH` x` x ÐÌà  àà8 ` àà ¸ àANSWER:à0h` x` xàI€believe€that€was€a€policy.Ðà hxhx ÐÌThree€other€Tokos€employees€discussed€two€other€Tokos€policies€during€their€testimony,€but€neitherÐ ¸ø Ðpolicy€dealt€directly€with€the€necessity€of€an€EKG€before€beginning€tocolysis€using€an€infusionÐ ¤ä Ðpump.׃K×Ý ƒ #ÃÝòòÚ  Ú40Ú  ÚóóÝ  Ý×  ×€€In€addition€to€introducing€this€testimony,€the€Richardsonsðð€lawyers€were€permitted€to€cross„Ð Ð Ðexamine€Dr.€Miller€and€the€Tokos€employees€regarding€their€failure€to€order€an€EKG€before€theyÐ |¼ Ðbegan€using€the€infusion€pump.€€Likewise,€one€of€the€Richardsonsðð€lawyers€argued€to€the€jury€thatÐ h¨ Ðthe€Tokos€employees€had€failed€to€follow€the€Tokos€protocol€requiring€a€recent€EKG€before€startingÐ T ” Ða€patient€on€an€infusion€pump.Ð @!€  ÐÌà  àWe€concur€with€the€trial€courtððs€determination€that€Tokosððs€policies€regarding€indicationsÐ #X" Ðand€contraindications€for€using€the€pump,€its€guidelines€for€determining€which€patients€wereÐ $D # Ðcandidates€for€using€the€pump,€and€its€procedures€for€implementing€infusion€pump€therapy€wereÐ ð$0!$ Ðrelevant€and€admissible.€€They€were€certainly€relevant€to€the€Richardsonsðð€negligence€claims€againstÐ Ü%"% ÐTokos.€€€They€were€likewise€relevant€with€regard€to€the€Richardsonsðð€claims€against€Dr.€Miller.€Ð À ÐWhile€these€policies€and€protocols,€like€terbutalineððs€labeling€and€parallel€PDR€reference,€do€not,Ð ¬ì Ðby€themselves€establish€a€physicianððs€standard€of€care€for€determining€when€the€infusion€pumpÐ ˜Ø Ðshould€be€used,€they€can€materially€assist€the€trier€of€fact€in€determining€whether€Dr.€Miller€actedÐ „Ä Ðnegligently€by€ordering€that€Ms.€Richardson€continue€to€receive€terbutaline€subcutaneously€byÐ p° Ðinfusion€pump€after€she€complained€that€the€terbutaline€she€was€taking€orally€was€causing€chest€pain.Ð \œ ÐÌà  àConsidering€the€record€as€a€whole,€we€find€no€basis€for€the€Richardsonsðð€assertion€that€theÐ 4 t Ðtrial€court€inappropriately€limited€their€ability€to€introduce€and€use€the€evidence€involving€TokosððsÐ  ` Ðpolicies€pertaining€to€obtaining€EKGððs€prior€to€beginning€infusion€pump€therapy.€€The€record€showsÐ  L  Ðthat€the€Richardsons€had€a€fair€chance€to€make€their€point€about€the€fact€that€neither€Dr.€Miller€norÐ ø 8  Ðany€of€the€Tokos€employees€working€with€Ms.€Richardson€obtained€an€EKG€before€commencingÐ ä $  Ðinfusion€pump€therapy.Ð Ð  ÐÌÌà@)ìàò òB.ó óˆÐ ”Ô  Ðà@yyìàòòò òTokos€Licensure€Statusó óóóˆÐ €À ÐÌà  àThe€Richardsons€also€assert€that€the€trial€court€erred€by€excluding€evidence€that€Tokos€hadÐ X˜ Ðnot€obtained€a€license€or€certificate€of€need€from€the€State€of€Tennessee.€€They€insist€that€thisÐ D„ Ðevidence€was€admissible€under€Tenn.€R.€Evid.€608€because€ð ðfailure€to€have€appropriate€licensing€isÐ 0p Ðcertainly€a€factor€affecting€the€credibility€of€Defendant€Tokos€in€this€case.ðð€€We€need€not€reach€theÐ \ Ðquestion€of€the€admissibility€of€this€sort€of€evidence€in€this€case€because€the€Richardsons€have€failedÐ H Ðto€demonstrate€just€how€state€law€required€Tokos€to€have€either€a€license€or€a€certificate€of€need€inÐ ô4 Ðorder€to€provide€a€prescribed€medical€device€to€a€hospitalized€patient€on€orders€of€her€physician.Ð à  ÐÌà  àWe€are€not€dealing€here€with€home€health€care€even€though€the€plan,€prior€to€the€events€of€Ð ¸ø ÐJune€27,€1993,€had€been€to€discharge€Ms.€Richardson€to€permit€her€to€continue€her€pregnancy€atÐ ¤ä Ðhome€for€ten€to€fourteen€more€days.€€Tokos€entered€the€picture€when€Dr.€Miller€ordered€an€infusionÐ Ð Ðpump€while€Ms.€Richardson€was€hospitalized.€€Tokos€sent€a€registered€nurse,€properly€licensed€inÐ |¼ ÐTennessee,€to€the€hospital€to€deliver€the€pump€and€to€educate€Ms.€Richardson€and€the€hospital€staffÐ h¨ Ðin€its€use.׃g×Ý ƒ #ÃÝòòÚ  Ú41Ú  ÚóóÝ  Ý×  ×€€The€Tokos€nurse€was€not€allowed€to€deliver€the€pump€until€the€hospital€approved€herÐ T ” Ðcredentials.€€Even€then,€she€was€not€allowed€to€touch€Ms.€Richardson.€€The€insertion€of€the€needleÐ @!€  Ðfor€the€pump€was€performed€by€a€registered€nurse€employed€by€the€hospital,€and€the€terbutaline€wasÐ ,"l! Ðobtained€from€the€hospital€pharmacy€on€Dr.€Millerððs€orders.Ð #X" ÐÌà  àFrom€this€evidence,€we€conclude€that€Tokos€was€supplying€a€piece€of€medical€equipment€andÐ ð$0!$ Ðproviding€consulting€advice€to€Dr.€Miller€and€the€hospital€staff€regarding€the€use€of€its€infusion€pumpÐ Ü%"% Ðand€the€proper€terbutaline€dosage€to€be€administered.€€Ms.€Richardson€has€pointed€to€no€state€lawÐ È&#& Ðor€regulation,€and€our€research€has€failed€to€discover€one,€requiring€that€Tokos€obtain€a€license€orÐ ´'ô#' Ðcertificate€of€need€for€its€activities€in€this€case.Ð  (à$( Їà@^^(ìàò òIII.ó óˆÐ À Ðà@ ìàòòò òThe€Requested€Missing€Evidence€Instructionó óóóˆÐ ¬ì ÐÌà  àThe€Richardsons€challenge€the€trial€courtððs€refusal€to€give€their€requested€jury€instructionÐ „Ä Ðregarding€a€missing€nursing€assessment€form€filled€out€by€Tokosððs€nurse€on€June€25,€1993.€€WhileÐ p° Ðthe€trial€court€permitted€the€Richardsonsðð€lawyer€to€argue€to€the€jury€that€it€could€conclude€that€theÐ \œ Ðcontents€of€the€missing€form€were€adverse€to€Tokos,€it€declined€to€give€an€instruction€based€onÐ H ˆ ÐTennessee€Pattern€Jury€Instructions€T.P.I.€3„Civil€2.04€(3d€ed.€1997)€(ð ðT.P.I.€3„Civilðð).€€We€haveÐ 4 t Ðdetermined€that€the€Richardsons€were€entitled€to€the€instruction€but€that€the€trial€courtððs€refusal€toÐ  ` Ðgive€the€instruction€is€not,€by€itself,€reversible€error€because€the€trial€court€permitted€theÐ  L  ÐRichardsonsðð€lawyer€to€argue€the€presumption€to€the€jury.€€However,€should€this€case€be€retried,€weÐ ø 8  Ðhave€concluded€that€the€Richardsons€will€be€entitled€to€the€instruction€if€Tokosðð€explanation€for€theÐ ä $  Ðmissing€nursing€assessment€from€and€the€surrounding€facts€remain€the€same.Ð Ð  ÐÌà  àAfter€Dr.€Miller€ordered€an€infusion€pump€for€Ms.€Richardson,€the€hospital€staff€telephonedÐ ¨è  ÐTokos€to€request€the€delivery€of€a€pump.€€Tokos€telephoned€Christine€Evans,€its€registered€nurse€inÐ ”Ô  Ðthe€Nashville€area,€and€instructed€her€to€deliver€a€pump€to€the€hospital€for€Ms.€Richardson.€€Ms.Ð €À ÐEvans,€accompanied€by€Jackie€Harris,€a€nurse€employed€by€A+€Stat€Home€Care,€took€the€pump€toÐ l¬ Ðthe€hospital.€€Upon€arriving€at€Ms.€Richardsonððs€room,€Ms.€Evans€reviewed€Ms.€RichardsonððsÐ X˜ Ðmedical€chart€and€took€her€medical€history€to€determine€whether€Ms.€Richardson€met€TokosððsÐ D„ Ðpreconditions€for€using€the€pump€and€to€obtain€the€information€needed€to€determine€how€muchÐ 0p Ðterbutaline€Ms.€Richardson€should€receive.€€Ms.€Evans€recorded€her€findings€on€two€Tokos€forms,Ð \ Ða€nursing€assessment€form€and€a€tocolytic€infusion€intake€form.€€She€placed€these€forms€in€theÐ H Ðpatientððs€file€she€maintained€and€sent€copies€to€Tokosððs€regional€office€in€Atlanta.€€According€toÐ ô4 ÐTokosððs€policy,€these€forms€would€have€been€sent€to€Tokosððs€office€in€California€after€Ms.Ð à  ÐRichardson€discontinued€using€the€pump.Ð Ì  ÐÌà  àDuring€discovery,€Tokos€produced€a€nursing€assessment€form€and€a€tocolytic€infusion€intakeÐ ¤ä Ðform.€€It€turned€out€that€the€nursing€assessment€form€that€Tokos€produced€was€not€the€form€thatÐ Ð ÐChristine€Evans€had€completed€on€June€25,€1993.€€It€was€not€even€a€Tokos€form.€€Rather,€it€was€onlyÐ |¼ Ðone€page€of€a€two„page€nursing€assessment€form€used€by€A+€Stat€Home€Care.€€The€form€was€not€inÐ h¨ ÐChristine€Evansððs€handwriting€and€was€signed€by€Lisa€Evans,€an€employee€of€A+€Stat€Home€CareÐ T ” Ðwho€was€not€present€at€the€hospital€on€June€25,€1993€when€Christine€Evans€obtained€the€neededÐ @!€  Ðmedical€information€from€Ms.€Richardson.€€Ð ,"l! ÐÌà  àAt€trial,€the€only€explanation€offered€by€Tokos€employees€for€the€absence€of€the€nursingÐ $D # Ðassessment€form€completed€by€Christine€Evans€on€June€25,€1993,€was€that€it€must€have€been€eitherÐ ð$0!$ Ðlost€in€the€mail€or€misfiled.€€No€explanation€was€offered€for€the€presence€in€the€file€of€the€nursingÐ Ü%"% Ðassessment€form€signed€by€Lisa€Evans,€who€was€not€even€at€the€hospital€on€June€25,€1993,€or€for€theÐ È&#& Ðpresence€in€the€file€of€the€tocolytic€infusion€intake€form€that€would€have€accompanied€the€missingÐ ´'ô#' Ðnursing€assessment€form.€€Accordingly,€the€Richardsons€requested€the€trial€court€to€give€the€T.P.I.Ð  (à$( Ð3„Civil€2.04€instruction€regarding€the€conclusions€to€be€drawn€from€a€partyððs€failure€to€introduceÐ Œ)Ì%) Ðevidence€that€it€could€have€produced.€€Noting€that€it€had€never€before€encountered€a€missingÐ x*¸&* Ðevidence€issue,€the€trial€court€declined€to€give€the€requested€instruction€because€there€was€no€proofÐ d+¤'+ Ðthat€Tokos€had€acted€maliciously€and€because€the€language€of€the€proposed€instruction€was€ð ðtooÐ P,(, Ðstrong.ðð€€However,€the€trial€court€permitted€Ms.€Richardsonððs€lawyer€to€ask€the€jury€to€considerÐ À Ðwhether€the€missing€nursing€assessment€form€might€have€indicated€that€Ms.€Evans€had€concludedÐ ¬ì Ðthat€Ms.€Richardson€was€not€a€proper€candidate€for€the€infusion€pump.׃O×Ý ƒ #ÃÝòòÚ  Ú42Ú  ÚóóÝ  Ý×  ×Ð ˜Ø ÐÌà  àA€trial€courtððs€instructions€should€be€complete€and€accurate€and€should€fairly€reflect€theÐ p° Ðpartiesðð€theories€of€the€case.€€òòSee€Ladd€v.€Honda€Motor€Co.óó,€939€S.W.2d€83,€102€(Tenn.€Ct.€App.Ð \œ Ð1996).€€They€must€carefully€consider€the€special€instructions€requested€by€the€parties€because€theÐ H ˆ Ðparties€are€entitled€to€these€instructions€(1)€if€they€are€supported€by€the€evidence,€(2)€if€they€embodyÐ 4 t Ða€theory€relied€on€by€the€parties,€(3)€if€they€are€correct€statements€of€the€law,€and€(4)€if€theirÐ  ` Ðsubstance€is€not€already€contained€in€other€portions€of€the€charge.€€òòSee€Ingram€v.€Earthmanóó,€993Ð  L  ÐS.W.2d€611,€636€(Tenn.€Ct.€App.€1998).€€Based€on€these€criteria,€the€Richardsons€were€entitled€toÐ ø 8  Ðan€instruction€based€on€T.P.I.€3„Civil€2.04.€Ð ä $  ÐÌà  àThe€ð ðmissing€evidenceðð€charge€in€T.P.I.€3„Civil€2.04€is€a€nod€in€the€direction€of€SherlockÐ ¼ü  ÐHolmesðð€famous€dog€that€did€not€bark.€€It€is€a€recognition€that€sometimes€the€absence€of€somethingÐ ¨è  Ðexpected€can€be€significant.€€In€Tennessee,€as€in€other€jurisdictions,€a€partyððs€failure€to€produce€aÐ ”Ô  Ðdocument€capable€of€shedding€light€on€a€material€contested€issue€can€give€rise€to€a€permissiveÐ €À Ðinference€that€the€missing€document€would€have€been€unfavorable€to€the€party€possessing€it.€€òòSeeóóÐ l¬ ÐTennessee€Law€of€Evidence€òòóóðð€401.9,€at€99.€€Parties€seeking€to€take€advantage€of€this€inference€mustÐ X˜ Ðdemonstrate:Ð D„ ÐÌà  à(1)à0 ` àthat€the€party€against€whom€the€inference€is€sought€could€have€introduced€theÐ \ Ðevidence€but€failed€to€do€so;ÐH` (#` (# ÐÌà  à(2)à0 ` àthat€the€document€was€uniquely€in€the€possession€of€the€party€against€whom€theÐ à  Ðinference€is€sought€and€that€party€could€have€produced€the€document€by€exercisingÐ Ì  Ðreasonable€diligence;иø` (#` (# ÐÌà  à(3)à0 ` àthat€the€document€was€not€equally€available€to€the€other€parties;ÐÐ` (#` (# ÐÌà  à(4)à0 ` àthat€the€document€would€not€have€been€cumulative€to€other€evidence;Ðh¨` (#` (# ÐÌà  à(5)à0 ` àthat€a€reasonable€person€under€the€same€or€similar€circumstances€would€haveÐ @!€  Ðproduced€the€document€had€it€been€favorable;€andÐ,"l!` (#` (# Їà  à(6)à0 ` àthat€the€party€against€whom€the€inference€is€sought€has€not€offered€a€reasonableÐ À Ðexcuse€for€failing€to€produce€the€document.Ьì` (#` (# ÐÌòòSeeóó€T.P.I.€3„Civil€2.04;€òòState€v.€Jonesóó,€598€S.W.2d€209,€224€(Tenn.€1980),€òòoverruled€on€otherÐ „Ä Ðgroundsóó,€òòState€v.€Shropshireóó,€874€S.W.2d€634,€638€(Tenn.€Crim.€App.€1993).Ð p° ÐÌà  àWhere€the€missing€evidence€is€a€document,€the€party€seeking€the€missing€evidence€instructionÐ H ˆ Ðmust€demonstrate€that€the€document€existed€and€was€in€its€adversaryððs€exclusive€control.€€òòSee€FaresÐ 4 t Ðv.€Foxóó,€603€N.Y.S.2d€892,€893€(App.€Div.€1993).€€The€party€must€also€demonstrate€that€the€partyÐ  ` Ðpossessing€the€document€could€have€produced€it.€€òòSee€Cleveringa€v.€J.I.€Case€Co.óó,€595€N.E.2d€1193,Ð  L  Ð1211€(Ill.€App.€Ct.€1992).€€To€avoid€a€missing€evidence€instruction,€the€party€failing€to€produce€aÐ ø 8  Ðdocument€in€its€possession€must€give€a€reasonable€explanation€for€failing€to€produce€it.€€òòSeeÐ ä $  Ðgenerally€State€v.€Wilsonóó,€687€S.W.2d€720,€724€(Tenn.€Crim.€App.€1984).Ð Ð  ÐÌà  àEvidence€that€the€party€failing€to€introduce€a€document€was€acting€maliciously€is€notÐ ¨è  Ðrequired.€€Seldom€will€parties€be€able€to€prove€that€their€adversary€maliciously€destroyed€or€secretedÐ ”Ô  Ða€missing€document.€€Courts€should€consider€giving€the€missing€evidence€instruction€where€theÐ €À Ðmissing€evidence€is€shown€to€be€unavailable€due€to€questionable€negligence,€òòsee€DeLaughter€v.Ð l¬ ÐLawrence€County€Hosp.óó,€601€So.€2d€818,€822€(Miss.€1992),€or€dubious€mishandling.€€òòSee€SacramonaÐ X˜ Ðv.€Bridgestone/Firestone,€Inc.óó,€106€F.3d€444,€447€(1st€Cir.€1997).Ð D„ ÐÌÌà  àA€jury€issue€is€created€when€the€party€seeking€the€missing€evidence€instruction€puts€onÐ H Ðevidence€showing€(1)€that€the€document€exists,€(2)€that€the€document€is€relevant,€and€(3)€that€theÐ ô4 Ðopposing€party€had€exclusive€control€of€the€document€and€the€party€possessing€the€document€proffersÐ à  Ðan€explanation€for€not€producing€it.€€òòSee€Beers€v.€Bayliner€Marine€Corp.óó,€675€A.2d€829,€831„33Ð Ì  Ð(Conn.€1996);€òòDeLaughter€v.€Lawrence€County€Hosp.óó,€601€So.€2d€at€821„22.€€When€the€party€failingÐ ¸ø Ðto€produce€a€document€claims€that€it€has€been€innocently€lost,€the€jury€should€decide€the€matter€forÐ ¤ä Ðitself€when€the€evidence,€viewed€as€a€whole,€colorably€creates€a€credibility€issue€about€whether€theÐ Ð Ðdocument€was€lost€or€not.€€òòSee€Bihum€v.€AT&T€Info.€Sys.,€Inc.óó,€16€Cal.€Rptr.€2d€787,€794„97€(Ct.Ð |¼ ÐApp.€1993);€òòsee€generally€Rogers€v.€Stateóó,€2€Tenn.€Crim.€491,€502„03,€455€S.W.2d€182,€187€(1970).Ð h¨ ÐÌà  àJuries€should€judge€credibility€issues.€€òòSee€Kinney€v.€Yazoo€&€M.V.R.R.óó,€116€Tenn.€450,€453,Ð @!€  Ð92€S.W.€1116,€1116€(1906);€òòLorentz€v.€Deardanóó,€834€S.W.2d€316,€320€(Tenn.€Ct.€App.€1992).€€IfÐ ,"l! Ða€jury€concludes€that€a€missing€document€was€genuinely€lost€and€that€the€documentððs€absence€is€notÐ #X" Ðbrought€about€by€manipulation,€then€the€jury€should€draw€no€inference€against€the€non„producingÐ $D # Ðparty€that€the€document€would€have€been€unfavorable.€€òòSee€Brewer€v.€Quaker€State€Oil€Ref.€Corp.óó,Ð ð$0!$ Ð72€F.3d€326,€334€(3rd€Cir.€1995).€€Ð Ü%"% ÐÌà  àThe€circumstances€surrounding€the€missing€nursing€assessment€form€created€a€jury€issue.€Ð ´'ô#' ÐThe€missing€nursing€assessment€form€was€solely€under€Tokosððs€control€and€was€not€equallyÐ  (à$( Ðavailable€to€the€Richardsons.€€In€light€of€the€evidence€regarding€Tokosððs€record€keeping€practices,Ð Œ)Ì%) ÐTokos€should€have€been€able€to€produce€the€document€without€much€difficulty.€€In€the€face€of€theÐ x*¸&* ÐRichardsonsðð€negligence€claims,€Tokos€can€reasonably€be€expected€to€introduce€the€nursingÐ d+¤'+ Ðassessment€form€because€it€would€have€supported€its€claim€that€Christine€Evans€made€a€careful€andÐ P,(, Ðcomplete€medical€assessment€of€Ms.€Richardson€before€beginning€her€on€the€infusion€pump.€€TheÐ À Ðdocument€would€not€have€been€cumulative€to€other€evidence€because€it€would€have€been€the€onlyÐ ¬ì Ðwritten€evidence,€prepared€contemporaneously€with€the€other€relevant€events,€of€the€informationÐ ˜Ø ÐChristine€Evans€used€to€assess€Ms.€Richardsonððs€suitability€and€to€determine€the€dosage€ofÐ „Ä Ðterbutaline€she€would€receive.Ð p° ÐÌà  àWhether€this€form€was€innocently€lost€in€the€mail€or€misplaced€in€Tokosððs€files€is€a€juryÐ H ˆ Ðquestion€in€light€of€two€facts.€€First,€Tokos€was€able€to€produce€the€tocolytic€infusion€intake€formÐ 4 t Ðthat€Christine€Evans€completed€at€the€same€time€she€completed€the€missing€nursing€assessment€form,Ð  ` Ðand€Tokos€offered€no€explanation€how€it€could€have€lost€one€form€but€not€the€other.€€Second,€TokosÐ  L  Ðoffered€no€explanation€for€the€presence€in€its€file€of€the€undated€nursing€assessment€form€apparentlyÐ ø 8  Ðcompleted€and€signed€by€a€person€who€was€not€a€Tokos€employee€and€who€was€not€even€present€atÐ ä $  Ðthe€hospital€on€June€25,€1993.€€Based€on€this€evidence,€a€jury€could€conclude€that€the€missingÐ Ð  Ðnursing€assessment€form€contained€information€indicating€that€Ms.€Richardson€did€not€meet€TokosððsÐ ¼ü  Ðown€patient€selection€criteria.€€A€jury€could€also€conclude€that€Tokos€could€not€produce€the€missingÐ ¨è  Ðnursing€assessment€form€because,€in€reality,€Ms.€Evans€never€completed€one.€€Either€conclusion€hasÐ ”Ô  Ða€direct€bearing€on€Tokosððs€defense€that€it€conducted€a€careful€medical€assessment€beforeÐ €À Ðdetermining€that€Ms.€Richardson€was€a€candidate€for€tocolysis€using€the€infusion€pump€and€settingÐ l¬ Ðthe€dosage€amounts€of€terbutaline€the€pump€would€administer.Ð X˜ ÐÌà  àThe€Richardsons€were€entitled€to€jury€instructions€on€every€factual€and€legal€issue€raised€byÐ 0p Ðtheir€pleadings€and€put€in€issue€by€their€evidence.€€However,€what€the€trial€court€took€away€with€oneÐ \ Ðhand,€it€gave€back€with€the€other€when€it€permitted€the€Richardsonsðð€lawyer€to€argue€the€missingÐ H Ðevidence€presumption€to€the€jury.€€Because€the€trial€court€permitted€the€Richardsonsðð€lawyer€to€makeÐ ô4 Ðrhetorical€use€of€the€presumption€in€closing,€we€do€not€find€that€declining€to€give€the€requestedÐ à  Ðinstruction,€in€and€of€itself,€affected€the€outcome€of€the€trial.€€Assuming,€however,€that€the€factsÐ Ì  Ðsurrounding€the€missing€nursing€assessment€form€remain€the€same,€the€trial€court€on€retrial€shouldÐ ¸ø Ðgive€an€instruction€based€on€T.P.I.€3€„€Civil€2.04€if€the€Richardsons€request€it.€€The€jury€should€beÐ ¤ä Ðpermitted€to€decide€for€itself€whether€the€missing€nursing€assessment€form,€if€produced,€would€beÐ Ð Ðadverse€to€Tokos.Ð |¼ ÐÌà@dd)ìàò òIV.ó óˆÐ T ” Ðà@w w ìàòòò òThe€Motions€for€Directed€Verdictó óóóˆÐ @!€  ÐÌà  àDr.€Miller€and€Tokos€assert€that€the€trial€court€should€have€granted€their€motions€for€directedÐ #X" Ðverdict€at€the€close€of€all€the€proof.€€Obviously,€were€we€to€affirm€the€juryððs€verdict€for€theÐ $D # Ðdefendants,€the€trial€courtððs€failure€to€direct€a€verdict€for€the€defendants€would€be€a€non„issue.€Ð ð$0!$ ÐHowever,€because€we€have€vacated€the€verdict€based€on€the€trial€courtððs€erroneous€exclusion€ofÐ Ü%"% Ðrelevant€evidence,€we€must€address€Dr.€Millerððs€and€Tokosððs€arguments€that€they€were€entitled€toÐ È&#& Ða€directed€verdict.Ð ´'ô#' ÐÌà@‹‹)ìàò òA.ó óˆÐ Œ)Ì%) ÐÌà  àTo€avoid€a€directed€verdict€under€Tenn.€R.€Civ.€P.€50,€the€non„moving€party€must€presentÐ d+¤'+ Ðsome€evidence€on€every€element€of€its€case€ð"ð€enough€evidence€to€establish€at€least€a€prima€facieÐ P,(, Ðcase.€€òòSeeóó€òòHarrogate€Corp.€v.€System€Sales€Corp.óó,€915€S.W.2d€812,€818€(Tenn.€Ct.€App.€1995).€Ð À ÐNormally,€a€directed€verdict€is€proper€only€where€no€material€evidence€exists€on€one€or€moreÐ ¬ì Ðelements€that€the€non„moving€party€must€prove.€€òòSee€generallyóó€òòConatser€v.€Clarksville€Coca„ColaÐ ˜Ø ÐBottling€Co.óó,€920€S.W.2d€646,€647€(Tenn.€1995).€€Whether€the€trial€court€should€have€directed€aÐ „Ä Ðverdict€presents€us€with€the€legal€question€of€whether€material€evidence€was€introduced€on€everyÐ p° Ðelement€sufficient€to€create€a€jury€issue.€€òòSeeóó€òòLazy€Seven€Coal€Sales€v.€Stone€&€Hindsóó,€813€S.W.2dÐ \œ Ð400,€403€(Tenn.€1991);€òòUnderwood€v.€HCA€Health€Servs.€of€Tenn.,€Inc.óó,€892€S.W.2d€423,€425€(Tenn.Ð H ˆ ÐCt.€App.€1994).€€òòDickson€v.€Stephensóó,€20€Tenn.€App.€195,€211,€96€S.W.2d€201,€211„12€(1935).Ð 4 t ÐÌà  àWhen€reviewing€a€trial€courtððs€disposition€of€a€motion€for€directed€verdict,€appellate€courtsÐ  L  Ðdo€not€resolve€disputes€in€the€evidence,€weigh€the€evidence,€òòsee€Conatser€v.€Clarksville€Coca„ColaÐ ø 8  ÐBottling€Co.óó,€920€S.W.2d€at€647,€or€òòóóevaluate€the€credibility€of€the€witnesses.€€òòSee€Benson€v.Ð ä $  ÐTennessee€Valley€Elec.€Coopóó.,€868€S.W.2d€630,€638„39€(Tenn.€Ct.€App.€1993).€€Instead,€we€reviewÐ Ð  Ðthe€evidence€most€favorably€to€the€party€against€whom€the€motion€is€made,€give€that€party€the€benefitÐ ¼ü  Ðof€all€reasonable€inferences€from€the€evidence,€and€disregard€all€evidence€contrary€to€that€partyððsÐ ¨è  Ðposition.€€òòSee€Eaton€v.€McClainóó,€891€S.W.2d€587,€590€(Tenn.€1994);€òòGann€v.€InternationalÐ ”Ô  ÐHarvester€Co.óó,€712€S.W.2d€100,€105€(Tenn.€1986).Ð €À ÐÌÌà  àDirected€verdicts€are€appropriate€only€when€reasonable€minds€can€reach€one€conclusion.€€òòSeeÐ D„ ÐWilliams€v.€Brownóó,€860€S.W.2d€854,€857€(Tenn.€1993);€òòCrosslin€v.€Alsupóó,€594€S.W.2d€379,€380Ð 0p Ð(Tenn.€1980).€€A€case€should€go€to€the€jury,€even€if€the€facts€are€undisputed,€when€reasonableÐ \ Ðpersons€could€draw€conflicting€conclusions€from€the€facts.€€òòSee€Gulf,€M.€&€O.R.R.€v.€Underwoodóó,Ð H Ð182€Tenn.€467,€474,€187€S.W.2d€777,€779€(1945);€òòPettus€v.€Hurstóó,€882€S.W.2d€783,€788€(Tenn.€Ct.Ð ô4 ÐApp.€1993).€€These€conclusion,€however,€must€be€based€on€more€than€speculation,€conjecture,€andÐ à  Ðguesswork.€€òòSee€Daniels€v.€White€Consol.€Indus.,€Inc.óó,€692€S.W.2d€422,€425€(Tenn.€Ct.€App.€1985).€Ð Ì  ÐÌà@)ìàò òB.ó óˆÐ ¤ä ÐÌà  àBoth€Dr.€Miller€and€Tokos€assert€that€the€trial€court€should€have€directed€a€verdict€in€theirÐ |¼ Ðfavor€at€the€close€of€all€the€proof€because€the€Richardsonsðð€evidence€failed€to€establish€causation.€Ð h¨ ÐMs.€Richardson€had€the€burden€to€prove€at€trial€that€she€suffered€injuries€she€would€not€otherwiseÐ T ” Ðhave€suffered€as€a€proximate€result€of€Dr.€Millerððs€and€Tokosððs€negligence.€€òòSeeóó€Tenn.€Code€Ann.Ð @!€  Ððð€29„26„115(a)(3);€òòKilpatrick€v.€Bryantóó,€868€S.W.2d€594,€598€(Tenn.€1993).€€Dr.€Miller€and€TokosÐ ,"l! Ðmaintain€that€Ms.€Richardsonððs€evidence€did€not€show€that€the€administration€of€terbutalineÐ #X" Ðproximately€caused€her€coronary€artery€dissection€and€heart€attack.€€Ð $D # ÐÌà  àThe€Richardsons€sought€to€prove€the€causal€link€between€the€terbutaline€she€was€taking€andÐ Ü%"% Ðher€coronary€artery€dissection€with€the€testimony€of€Dr.€Ronald€Krone,€a€Missouri€cardiologist,€andÐ È&#& ÐDr.€James€Dingfelder,€a€North€Carolina€obstetrician€and€gynecologist.€€Dr.€Krone€saw€Ms.Ð ´'ô#' ÐRichardson€approximately€a€year€after€her€heart€attack.€€In€addition€to€examining€Ms.€RichardsonÐ  (à$( Ðhimself,€he€reviewed€her€hospital€records.€€Based€on€his€medical€experience€and€his€knowledge€ofÐ Œ)Ì%) Ðthe€plaintiff,€Dr.€Krone€testified€sure„footedly€that€Ms.€Richardsonððs€heart€damage€was€caused€byÐ x*¸&* Ðthe€splitting€of€an€artery€serving€her€heart.€€When€asked€for€his€professional€opinion€of€what€causedÐ d+¤'+ Ðthe€arterial€splitting€that€led€to€the€heart€attack,€he€answered€that€terbutaline,€in€his€opinion,€increasedÐ P,(, Ðthe€risk€of€heart€attacks€in€pregnant€women€and€the€administration€of€terbutaline€is€what€caused€Ms.Ð À ÐRichardsonððs€heart€attack.׃×Ý ƒ #ÃÝòòÚ  Ú43Ú  ÚóóÝ  Ý×  ×Ð ¬ì ÐÌà  àIn€addition,€Dr.€Dingfelder€gave€the€following€opinion€with€regard€to€causation:€Ð „Ä ÐÌà8  àà8` Ð Ð àI€believe€after€looking€at€all€of€the€alternative€explanations€for€thisÐ \œ Ðpatientððs€injury€which€have€been€put€forward€and€which€I€haveÐ H ˆ Ðconsidered,€including€shock€at€hearing€bad€news,€and€something€thatÐ 4 t Ðshe€was€born€with,€a€congenital€anomaly,€these,€in€my€opinion,€paleÐ  ` Ðin€significance€to€the€obvious€known€effects€of€terbutaline.Ð L ` x` x ÐÌà8  àà8` Ð Ð àà ¸ àI€mean,€this€patient€has€already€manifested€chest€pain€fromÐ ä $  Ðterbutaline€to€begin€with.€€So€itððs€perfect€medical€logic,€in€myÐ Ð  Ðopinion,€that€terbutaline€is€the€cause.мü ` x` x ÐÌà  àDr.€Miller€and€Tokos€attack€Dr.€Dingfelderððs€testimony€as€contradicting€his€prior€depositionÐ ”Ô  Ðtestimony€and€as€being€medically€weak€because€Dr.€Dingfelder€was€not€a€cardiologist.€€Dr.Ð €À ÐDingfelderððs€testimony€may€very€well€be€subject€to€attack€on€these€grounds.€However,€this€court€isÐ l¬ Ðcharged€with€viewing€the€challenged€testimony€in€the€strongest€possible€light€favoring€theÐ X˜ ÐRichardsons.€€Weighing€the€evidence€is€the€juryððs€task.€€When€we€view€both€physiciansðð€testimonyÐ D„ Ðfavorably,€and€we€discard€everything€that€would€lessen€its€weight,€we€cannot€say€that€Dr.€KroneððsÐ 0p Ðand€Dr.€Dingfelderððs€testimony€provided€no€material€evidence€on€causation.€€Weak€or€strong,€theirÐ \ Ðtestimony€at€least€created€a€jury€question€on€causation,€and€therefore€the€trial€court€did€not€err€inÐ H Ðrefusing€to€direct€a€verdict€on€that€ground.Ð ô4 ÐÌà@‹‹)ìàò òV.ó óˆÐ Ì  Ðà@ßßìàòòò òThe€Dismissal€of€Principal€Mutual€Life€Insurance€Companyó óóóˆÐ ¸ø ÐÌà  àThe€final€issue€involves€the€trial€courtððs€dismissal€of€Principal€Mutualððs€interveningÐ Ð Ðcomplaint.€€Ms.€Richardson€had€employer„provided,€non„contributory€group€health€insuranceÐ |¼ Ðunderwritten€by€Principal€Mutual.€€Her€policy€contained€a€provision€stating€that€ð ðwhere€allowed€byÐ h¨ Ðlawðð€an€insured€who€receives€benefits€for€sickness€or€injury€and€who€has€ð ða€lawful€claimðð€againstÐ T ” Ðthird€parties€for€damages€related€to€that€sickness€or€injury€must€reimburse€the€insurance€companyÐ @!€  Ðfor€payments€made€on€the€insuredððs€behalf€out€of€any€recovery€the€insured€receives€from€a€third„partyÐ ,"l! Ðwrongdoer.׃d×Ý ƒ #ÃÝòòÚ  Ú44Ú  ÚóóÝ  Ý×  ׀Р#X" ÐÐ $D # Ðà  àFollowing€Ms.€Richardsonððs€heart€attack,€Principal€Mutual€paid€$52,434.54€in€medical€bills.€Ð À ÐAfter€the€Richardsons€filed€suit€against€Dr.€Miller,€Tokos,€and€others,€Principal€Mutual€sought€toÐ ¬ì Ðintervene€based€on€its€contractual€right€to€reimbursement€and€sought€reimbursement€out€of€anyÐ ˜Ø Ðrecovery€Ms.€Richardson€may€obtain€in€her€malpractice€action.€€The€trial€court€dismissed€PrincipalÐ „Ä ÐMutualððs€complaint€evidently€on€the€theory€that€Tenn.€Code€Ann.€ðð€29„26„119€prohibited€Ms.Ð p° ÐRichardson€from€recovering€any€medical€expenses€that€had€been€paid€by€Principal€Mutual.€€Ð \œ ÐÌà  àTenn.€Code€Ann.€ðð€29„26„119€states€that€a€medical€malpractice€plaintiff€may€not€recover€forÐ 4 t Ðthe€cost€of€medical€care€if€that€cost€was€indemnified€in€whole€or€in€part€by€employer„providedÐ  ` Ðinsurance.€€The€statute€seeks€to€prohibit€injured€parties€from€making€a€double€recovery€by€reducingÐ  L  Ða€plaintiffððs€recovery€by€the€amount€of€benefits€paid€by€employer„provided€insurance.€€òòSeeóó€òòNanceÐ ø 8  Ðv.€Westside€Hosp.óó,€750€S.W.2d€740,€742€(Tenn.€1988).€€Excluded,€however,€from€the€statuteððsÐ ä $  Ðgeneral€operation€are€collateral€payments€made€where€the€collateral€payor€has€subrogation€rights.€Ð Ð  ÐòòSeeóó€òòNance€v.€Westside€Hosp.óó,€750€S.W.2d€at€743.€€Where€the€injured€insured€must€repay€the€insurerÐ ¼ü  Ðout€of€any€damages€recovered,€the€insured€gets€no€double€recovery.€€Stated€another€way,€where€aÐ ¨è  Ðright€of€subrogation€exists€or€where€the€tort€victim€has€a€legal€obligation€to€repay€the€collateralÐ ”Ô  Ðsource€payor,€then€the€victimððs€losses€have€not€been€ð ðreplaced€or€indemnifiedðð€for€purposes€of€Tenn.Ð €À ÐCode€Ann.€ðð€29„26„119.€€òòSeeóó€òòNance€v.€Westside€Hosp.óó,€750€S.W.2d€at€743;€òòHughlett€v.€ShelbyÐ l¬ ÐCounty€Health€Care€Corp.óó,€940€S.W.2d€571,€574€(Tenn.€Ct.€App.€1996).Ð X˜ ÐÌà  àIn€this€case,€Ms.€Richardsonððs€legal€obligation€to€repay€the€approximately€$52,000€of€coveredÐ 0p Ðmedical€expenses€is€contractual.€€As€part€of€her€health€coverage,€she€has€contractually€agreed€toÐ \ Ðreimburse€Principal€Mutual€for€medical€benefits€paid€on€her€behalf€if€she€subsequently€receives€thoseÐ H Ðamounts€from€third€parties€responsible€for€her€injury.€€Contractual€provisions€like€Principal€MutualððsÐ ô4 Ðare€enforceable€to€the€extent€that€an€insured€has€received€full€compensation€and€has€been€madeÐ à  Ðwhole€for€his€or€her€losses.€€òòSeeóó€òòYork€v.€Sevier€County€Ambulance€Auth.óó,€8€S.W.3d€at€621;€òòBoard€ofÐ Ì  ÐTrustees€v.€Gravesóó,€No.€M1997„00069„COA„R3„CV,€1999€WL€1086454,€at€*2€n.4€(Tenn.€Ct.€App.Ð ¸ø ÐDec.€3,€1999)€(No€Tenn.€R.€App.€P.€11€application€filed).׃×Ý ƒ #ÃÝòòÚ  Ú45Ú  ÚóóÝ  Ý×  ×€€As€a€matter€of€contract€law,€PrincipalÐ ¤ä ÐMutual€may€legitimately€seek€reimbursement€from€Ms.€Richardson.€€Consequently,€her€losses€haveÐ Ð Ðnot€been€ð ðreplaced€or€indemnifiedðð€by€her€own€health€insurance,€and€Tenn.€Code€Ann.€ðð€29„26„119Ð |¼ Ðdoes€not€prevent€her€from€pursuing€recovery€of€those€medical€expenses€against€Dr.€Miller€and€Tokos.€Ð h¨ ÐFor€that€reason,€the€trial€court€should€not€have€dismissed€Principal€Mutualððs€intervening€complaint.Ð T ” ÐÌà@dd)ìàò òVI.ó óˆÐ ,"l! ÐÌà  àBased€on€the€foregoing,€we€reverse€the€judgment€dismissing€the€Richardsonsðð€claims€againstÐ $D # ÐDr.€Miller€and€Tokos€and€remand€the€case€for€a€new€trial€consistent€with€this€opinion.€€We€tax€theÐ ð$0!$ Ðcosts€of€this€appeal€in€equal€proportions€to€James€Miller,€M.D.€and€to€Tokos€Medical€CorporationÐ Ü%"% Ðfor€which€execution,€if€necessary,€may€issue.Ð È&#& ÐÌà  àà ` àà ¸ àà  àà h àà À àà  à_____________________________Ð  (à$( Ðà  àà ` àà ¸ àà  àà h àà À àà  àWILLIAM€C.€KOCH,€JR.,€JUDGE