ÿWPC Xi²äø,îÂeµHŒ6ä?%ù$DgêÜÄßbs$–׎øÍ¸Ä¼ £eéji1T)e4¸ï¤«,µýZ€ña"Ž" 0Ðò„ÞÒàͰFB›,oöÙ( ª ¥¼¦f׸xÛ[KïÁhamT^ø,lüÃÍÜ "À=[riŒ¥ZÕð¼N9UoÉ2[Zàà {]ë·êÙžûß(5¾œìmy#Uü §©¤€Y›8œŽ·èf‡‘I.¶¬ëU󹉑%ܪ¿ðŠ'nN>ÆŽR#XùŸPRÏæª„9‹7ÿÜ®@Ócv놊Øí¹'ÍyéU%–%¬¼ˆÇjW =©¼b[w”8ÍÙñ)™œ©V‰:zÎgà•MZóIS¹±ÉSøÚê¶HâRdüc²™LUÀ‰ØJã“Ñ •! m ñCãÛù\á5™gÍ/8 M:€UKQ ܱ¬ÐÛ(g¯íÀ8Go4\k£F8c[ó6ÄYRy)²€AÉ+Ãà.ò‹°Mšëˆ ¤Ù×0D)À¥õJ Qã#B;8Ÿb™Š›$Jˈ¶i4?„Õcáâ`ŽW|.ÉÎê†ý¯ŒçßÅùsφ•X/d¾Í…uÊü¤€…4F Z 0(i ‘ w@™  Ù UNå 33 0lf 0DÒ U: UNP P P P P P P P P P P P P UBž %à à à à à à à à à à à à Bæ æ æ æ D3 0D6666666666666666666666666666666666666666666666666666666666666666666666666666666666 AOzÆÉÉ 0D D/Ó Bf|œ$ÔøÔô3|xt($¡¡ `abDcdeEfgDhiÓ€ Ô€ XJXXXÔÔ€ Ã; X XJÔÓ  ÓÔ Ad ÔFILEDÔ€ XJX  Ã;ÔÐ  ÐÌò òAugust€31,€1998Ð šš ÐÌCecil€Crowson,€Jr.ÌÔ€ ô ¨ ôX XJÔAppellate€Court€Clerkó ó(ÈhH  Z ‹6Times New Roman Regular )Ý ƒ úÝ$Ýà  àòòÚ  Ú1Ú  ÚóóÝ  ÝÔ€ XwXXXÔÔ€ &0í&X XwÔEach€vertebra€has€left€and€right€pedicles€which€face€out€and€are€more€readily€accessible€to€a€Ð  Ðà0  àsurgeon€than€other€parts€of€the€vertebra.((3úÝ$¤¤Ý ƒ!ÝÝ  Ýà  àòòÚ  Ú0Ú  Úóó(#Ã$òòÚ  Ú0Ú  Úóó,c½¬AZ‹"Arial Regular(ÈhH  Z ‹6Times New Roman Regular<þ6X9`(*Courier 12pt10cpiX d&&&&'ÿÿdxd(3¯$££Ý ƒ!ÝÝ  Ý€-‚ƒCþÿ<< CÿÿƒLevel 1Level 2Level 3Level 4Level 5($$””ò òÚ  Ú1Ú  Úó ó„„'÷ÿ dxdüÿP PdÝ ƒ!ÝÝ  Ýñiñ›ñiñѰÑÒܰÒÑ ý ÑÑTR[  AØ'ÿ Legal3Ø' AØ'ÿ Legalÿ3Ø'TÑÑ7€jYXXdÈdÈ7ÑÔ€XwXXXÔÔ€Š4ŠXXwÔñiñßr€*<,(j 8` `€€@EÈ ` ttx$ð Õrß›ñiñ€€€€à@j j ‚àò òIN€THE€COURT€OF€APPEALS€OF€TENNESSEEˆÐ  ÐÌà@>>%‚àAT€KNOXVILLEˆÌó óÌÌÌDON€HARDEN,à ä àà < àà ” àà ì à)€C/A€NO.€03A01„9801„CV„00020Ð   Ðà 4 àà Œ àà ä àà < àà ” àà ì à)Ìà 4 àPlaintiff„Appellant,à < àà ” àà ì à)€KNOX€CIRCUITÐ  Ðà 4 àà Œ àà ä àà < àà ” àà ì à)Ìv.à 4 àà Œ àà ä àà < àà ” àà ì à)€HON.€WHEELER€ROSENBALM,Ð   Ðà 4 àà Œ àà ä àà < àà ” àà ì à)€JUDGEÌDANEK€MEDICAL,€INC.,à ” àà ì à)Ð   Ðà 4 àà Œ àà ä àà < àà ” àà ì àœ)€AFFIRMED€AND›Ìà 4 àDefendant„Appellee.à ” àà ì àœ)€REMANDED›Ð  ÐÌœÌÌ›ÌÌCLINT€J.€WOODFIN,€RALPH€BROWN€&€ASSOCIATES,€Knoxville,€for€Plaintiff„¼Appellant.ÌÌROBERT€R.€CAMPBELL,€HODGES,€DOUGHTY€&€CARSON,€and€STEPHEN€S.ÏPHILLIPS€AND€JAMES€M.€BECK,€PEPPER€HAMILTON,€LLP,€Philadelphia,€PA,Ïfor€Defendant„Appellee.ÌÌÌÌà@%‚àò òòòO€P€I€N€I€O€Nóóó óˆÐ $ ÐÌÌà 4 àà Œ àà ä àà < àà ” àà ì àà D àà œ àFranks,€J.ÌÌÌÓÓà 4 àà Œ àIn€this€action€for€allegedly€manufacturing€a€defective€product€whichÏharmed€plaintiff,€the€Trial€Judge€granted€defendant€summary€judgment,€and€plaintiffÏhas€appealed.Ìà 4 àà Œ àThe€principal€issue€on€appeal€stated€in€plaintiffððs€brief€is:ÌÓÓà0 4 àà0Œ 4(#4(#àDid€the€Trial€Court€commit€reversible€error€by€holding€that€no€genuineÏissues€of€material€fact€existed€in€the€record€on€August€19,€1997,€andÏgranting€summary€judgment€to€the€defendant€on€that€basis.Ð Œ (#Œ (# ÐÌÓÓAppellant€in€his€brief€argues€that€the€Trial€Judge€committed€several€errors€which€wereÏnot€specified€as€issues€in€the€statement€of€issues.€€The€issue€as€stated€is€simply€notÏreviewable.€€We€said€in€òòLeeson€v.€Chernauóó,€737€S.W.2d€634€(Tenn.€App.€1987)€p.637:Ð :þ23ý  ÐÓÓà0 4 àà0Œ 4(#4(#àT.R.A.P.€does€not€contemplate€that€an€appellant€may€submit€one€blanketÏissue€as€to€the€correctness€of€the€judgment€and€thereby€open€the€door€toÏargument€upon€various€issues€which€might€affect€the€correctness€of€theÏjudgment.Ð Œ (#Œ (# ÐÌÓÓà 4 àà Œ àSince€the€appellee€effectively€cured€this€defect€by€filing€a€ð ðcounter„¼statement€of€the€issues€presentedðð,€we€will€consider€the€issues€presented.Ìà 4 àà Œ àThis€case€arises€from€an€operation€that€was€performed€by€Dr.€GlennÏJeffries€in€1992€on€the€plaintiff€who€had€been€suffering€back€pain.€€Dr.€JeffriesÏdetermined€that€plaintiff€would€benefit€from€back€surgery€stabilized€by€spinalÏinstrumentation.€€In€March€of€1992,€Dr.€Jeffries€performed€the€surgery€and€implantedÏa€construct€built€from€components€made€by€Defendant€Danek€Medical€,€Inc.Ï(ð ðDanekðð).€€In€the€operative€procedure,€Dr.€Jeffries€used€bone€screws€to€attach€theÏconstruct€through€the€pedicles€of€plaintiffððs€vertebrae.׃×Ý ƒ #ÃÝòòÚ  Ú1Ú  ÚóóÝ  Ý×  ×€€Plaintiffððs€condition€improvedÐ  Ðafter€surgery,€but€in€July€of€1993€his€pain€returned.€€On€August€8,€1995,€plaintiffÏunderwent€surgery€to€have€the€hardware€removed€from€his€back.Ìà 4 àà Œ àThis€action€then€followed€in€October€1995,€wherein€plaintiff€allegedÏinjuries€from€the€implantation€of€a€Danek€device€that€œwas›€defective€and/orÏunreasonably€dangerous.€€In€June€1996,€Danek€filed€a€Motion€for€Judgment€on€theÏPleadings,€arguing€that€the€complaint€failed€to€state€a€cause€of€action.€€Plaintiff€movedÏto€amend€his€complaint€on€July€17,€1996.€€On€July€30,€1996,€the€Trial€Court€grantedÏDanekððs€motion€and€dismissed€the€amended€complaint.€€However,€on€August€8,€1996,Ïplaintiff€moved€to€file€a€second€amended€complaint€and€for€reconsideration€of€the€JulyÏ30€order.€€The€Trial€Court€allowed€the€second€amended€complaint,€but€deniedÏreconsideration€of€its€dismissal€of€the€claims€in€the€first€amended€complaint.€€On€JuneÏ4,€1997,€Danek€moved€for€summary€judgment€on€the€allegations€in€the€secondÏamended€compliant,€and€as€a€part€of€that€motion,€Danek€included€Dr.€JeffriesððÐ 6// Ðdeposition.€€On€June€30,€1997€plaintiff€gave€notice€to€depose€Dr.€Jeffries.€€€On€AugustÏ15,€1997,€plaintiff€filed€a€Notice€of€Deposition.€€On€August€19,€1997,€the€Trial€CourtÏquashed€the€Notice€and€denied€plaintiffððs€Motion€to€Amend€and€granted€DanekððsÏMotion€for€Summary€Judgment.€€Ìà 4 àà Œ àPlaintiff€contends€that€the€Trial€Court€erred€in€granting€summaryÏjudgment€on€his€failure€to€warn€œclaimñRñsñRñ.›€€He€argues€that€defendant€owed€a€duty€to€warnÏhim€that€the€safety€of€its€system€had€been€determined€only€for€certain€types€ofÏconditions€and€that€implanting€a€pedicle€screw€system€was€a€potentially€dangerousÏprocedure€that€only€experienced€surgeons€performed.€€Ìà 4 àà Œ àAs€the€moving€party€for€summary€judgment,€the€defendant€had€theÏburden€of€demonstrating€that€no€genuine€issue€of€material€fact€existed.€òòShadrick€v.Ð XP ÐCoker,óó€963€S.W.2d€726€(Tenn.€1998).€€On€appeal€ð ðwe€are€required€to€view€theÐ `X Ðevidence€in€the€light€most€favorable€to€the€non„moving€party,€draw€all€reasonableÏinferences€in€his€favor,€and€discard€all€countervailing€evidence.ððòò€Id.óó€€SummaryÐ p!h Ðjudgment€is€only€proper€ð ð[i]f€both€the€facts€and€conclusions€to€be€drawn€from€the€factsÏpermit€a€reasonable€person€to€reach€only€one€conclusion€.€.€.ðð€òòId.óó€€Ð €%x Ðà 4 àà Œ àSummary€judgment€was€proper€on€this€issue€because€the€treatingÏphysician€was€aware€of€the€risks€and€limitations€of€the€surgery€he€performed€œñSñandñSññUññTñWITHñTññUññVñwithñVñ›€theÏhardware€he€installed.€€The€defendant€œrñWñaisedñWññXñelied€onñXñ›€the€defense€of€learned€intermediary.€ÏUnder€this€doctrine,€manufacturers€of€certain€medical€products€ð ðmay€reasonably€relyÏon€intermediaries€to€transmit€their€warnings€and€instructions.ðð€òòPittman€v.€Upjohn€Co.,óóÐ ¨/ (( Ð890€S.W.2d€425,€429€(Tenn.€1994).€This€defense€is€based€upon€the€pivotal€role€thatÏphysicians€play€in€the€distribution€of€prescription€products.€òòId.€óó€Physicians€can€beÐ ¸3°,, Ðlearned€intermediaries€only€when€they€receive€adequate€warnings.€€òòId.óó€Thus,Ð À5¸.. Ðmanufacturers€are€not€shielded€from€liability€if€they€provide€inadequate€warnings€toÏphysicians.€€òòId.óó€€Ð Ð9È22 Ðà 4 à€€à Œ àIn€order€to€recover€for€failure€to€warn€under€the€learned€intermediaryÐ  Ðdoctrine,€a€plaintiff€must€show€:€(1)€that€the€defendant€failed€to€warn€the€physician€ofÏa€risk€associated€with€the€use€of€the€product€not€otherwise€known€to€the€physician;€andÏ(2)€that€the€failure€to€warn€the€physician€was€both€a€cause€in€fact€and€proximate€causeÏof€the€plaintiffððs€injury.€63A€Am.Jur.2d€òòProducts€Liability€óóðð1200€(1984).€Ð (  Ðà 4 àà Œ àGenerally,€€ð ða€manufacturer€will€be€absolved€of€liability€for€failure€toÏwarn€for€lack€of€causation€where€the€consumer€was€already€aware€of€the€danger,Ïbecause€the€failure€to€warn€cannot€be€the€proximate€cause€of€the€userððs€injury€if€theÏuser€had€actual€knowledge€of€the€hazards€in€question.ðð€òòId.óó€at€ðð1162.€€Under€thisÐ H@ Ðdoctrine,€physicians€are€the€ð ðconsumersðð€who€must€be€warned.€€Thus,€it€is€generallyÏheld€that€the€learned€intermediary€doctrine€may€shield€a€manufacturer€from€liabilityÏwhen€the€physician€was€independently€aware€of€the€risks€involved.òò€€Id.óó€at€ðð1162.€€òòSeeÐ `X ÐOdom€v.€G.D.€Searle€&€Co.,€óó979€F.2d€1001€(4th€Cir.€1992)€(applying€South€CarolinaÐ h` Ðlaw);€€òòStanback€v.€Parke,€Davis€&€Co.óó,€657€F.2d€642€(4th€Cir.€œ19ñYñ??ñYññZñ81ñZñ)(applying›Ð p!h ÐVirginia€law);€òòSpychala€v.€G.D.€Searle€&€Co.,óó€705€F.Supp.€1024€(D.N.J.€1988)Ð x#p Ð(applying€New€Jersey€law);€€òòAshman€v.€SK€&€F€Lab€Co.óó,€702€F.Supp€1401€(N.D.€Ill.Ð €%x М19ñ_ñ??ñ_ññ`ñ88ñ`ñ)(applying›€Illinois€law);€òòZanzuri€v.€G.D.€Searle€&€Co.óó,€748€F.Supp.€1511€(S.D.Ð ˆ'€  ÐFla.€œ19ñ[ñ??ñ[ññ]ññ\ñ88ñ\ññ]ññ^ñ90ñ^ñ)(applying›€Florida€law);€òòAndre€v.€Mecta€Corp.óó,€587€N.Y.S.2d€334,€(NY.Ð )ˆ"" ÐApp.€Div.€1992)€òòappeal€deniedóó,€648€N.E.2d€791.€€Ð ˜+$$ Ðà 4 àà Œ àIn€Dr.€Jeffriesðð€affidavit€submitted€by€defendant,€he€stated€that€he€wasÏfully€aware€of€the€risks€involved€in€using€the€hardware€in€this€type€of€surgery.€ÏMoreover,€€he€stated€that€he€was€familiar€with€the€€FDA€regulatory€status€of€theÏproduct.€€Finally,€he€stated€that€he€did€not€rely€upon€certain€literature€distributed€orÏsponsored€by€the€defendant€in€making€his€determinations.€€Thus,€the€defendantððsÏalleged€failure€to€warn€œñañplaintiff€ñañis›€not€considered€to€be€the€proximate€cause€ofÏplaintiffððs€injury€under€this€doctrine.€€While€the€ð ðindependent€knowledgeðð€defense€isÐ Ð9È22 Ðnot€universally€accepted,€òòsee€Seley€v.€G.D.€Searle€&€Co.óó,€423€N.E.2d€831€Ohio€1981),Ð  Ðwe€follow€the€majority€view€among€the€courts€that€have€decided€this€issue,€œñbñandñbññcñwhichñcñ›€isÏconsistent€with€Tennessee€case€law.€òòSee€Ball€v.€Mallinkrodt€Chem.€Worksóó,€381Ð   ÐS.W.2d€563,€568€(Tenn.€App.€1964).€€(Trial€Court€did€not€err€in€refusing€to€submitÏimproper€warning€claims€to€jury€when€ð ðthere€was€no€evidence€that€[the€treatingÏphysician]€relied€upon€the€brochure€and€all€of€the€evidence€shows€that€he€was€fullyÏaware€of€the€toxicity.€.€.€ð ð).Ìà 4 àà Œ àPlaintiff€also€argues€that€the€Trial€Court€erred€in€granting€judgment€onÏthe€issue€of€his€negligence€per€se€claim.€€The€complaint€alleges€that€defendant€violatedÏ21€U.S.C.€ðð€360€of€the€Food,€Drug€and€Cosmetic€Act€(ð ðFDCAðð).€€Ìà 4 àà Œ àPlaintiff€contends€that€common€law€negligence€suits€are€not€preemptedÏby€the€FDCA.€òòSeeóó€òòMedtronic,€Inc.€v.€Lohr,óó€116€S.Ct.€2240€(1996).€€AlthoughÐ `X ÐòòMedtronic€óóestablishes€that€state€common€law€negligence€claims€are€generally€notÐ h` Ðpreempted,€it€does€not€resolve€the€precise€issue€in€this€case.€€The€defendant€does€notÏargue€that€the€negligence€per€se€claim€is€preempted.€€Rather,€it€argues€that€since€theÏFDCA€does€not€provide€for€a€private€right€of€action,€allowing€negligence€per€se€claimsÏbased€on€violations€of€the€statute€would€be€contrary€to€Congressional€intent.Ìà 4 àà Œ à21€U.S.C.€ðð337€provides:ÌÓÓà 4 àà8 Œ àExcept€as€provided€in€subsection€(b)€of€this€section,€all€suchÏproceedings€for€the€enforcement,€or€to€restrain€violations,€of€thisÏchapter€shall€be€by€and€in€the€name€of€the€United€States.Ð Œ Ð Œ Ð  ÐÌÓÓà 4 àà Œ àThus,€it€is€necessary€to€determine€if€it€would€be€proper€to€use€the€FDCAÏprovision€as€a€basis€for€a€negligence€per€se€claim.Ìà 4 àà Œ àIn€order€to€recover€under€the€theory€of€negligence€per€se,€a€party€mustÏestablish€three€elements.€€First,€the€defendant€must€have€violated€a€statute€or€ordinanceÏthat€imposes€a€duty€or€prohibition€for€the€benefit€of€a€person€or€the€public.€òòMemphisÐ È7À00 ÐStreet€Railway€v.€Haynesóó,€81€S.W.374€œ(ñeññdñ€ñdññeññfñTenn.€ñfñ1904).›€€Second,€the€injured€party€mustÐ Ð9È22 Ðbe€within€the€class€of€persons€intended€to€benefit€from€or€be€protected€by€the€statute.ÏòòTraylor€v.€Coburnóó,€597€S.W.2d€319€(Tenn.App.€1980).€€Finally,€the€injured€party€mustÐ   Ðshow€that€the€negligence€was€the€proximate€cause€of€the€injury.òò€€Long€v.€BrooksideÐ   ÐManoróó,€885€S.W.2d€70€(Tenn.€App.€1994).€Ð   Ðà 4 àà Œ àThe€FDCA€was€designed€to€protect€the€public€as€a€whole.€€ð ðòòToole€v.Ð (  ÐRichardson„Merrellóó,€60€Cal.Rptr.€398,€409€(Cal.Ct.App.€1967)€(citing€òòUnited€States€v.Ð 0(  ÐSullivanóó,€332€U.S.€689€(1948)).€€Since€the€statute€was€designed€at€least€in€part€toÐ 80  Ðprotect€the€public€from€unsafe€medical€products,€the€plaintiff€has€met€the€first€twoÏrequired€elements.€€The€issue€thus€becomes€whether€the€FDCAððs€lack€of€a€privateÏcause€of€action€precludes€using€it€as€a€basis€for€negligence€per€se€claims.Ìà 4 àà Œ àWe€have€been€cited€no€Tennessee€authority€which€has€determinedÏwhether€a€violation€of€the€FDCA€can€support€a€negligence€per€se€claim.€DefendantÏcites€òòRogers€v.€Memphis€City€Schoolsóó,€1997€WL€675194€(Tenn.€App.)€for€itsÐ h` Ðcontention€that€FDCA€violations€cannot€support€negligence€claims.€€In€òòRogers,€óótheÐ p!h Ðplaintiff€sought€to€bring€a€negligence€action€under€the€Tennessee€Tort€Liability€Act.€ÏThis€claim€was€based€in€part€on€the€defendantððs€alleged€violation€of€the€federalÏIndividuals€With€Disabilities€Act€(IDEA).€€The€plaintiff€sought€to€recover€damages€forÏpain€and€suffering,€which€were€not€available€under€the€remedial€provisions€of€theÏIDEA.€€The€court€determined€that€the€plaintiff€could€not€circumvent€or€supplement€theÏIDEAððs€provisions€merely€by€bringing€a€state€law€claim.€€Since€the€IDEA€constitutedÏð ðthe€exclusive€remedy€for€a€child€with€disabilities€asserting€the€right€to€a€freeÏappropriate€public€education,ðð€the€plaintiff€ð ðfailed€to€state€a€claim€under€the€TGTLA.ððÏòòId.óó€at€*4.Ð ¸3°,, Ðà 4 àà Œ àWhile€òòRogersóó€is€an€instructive€and€well„reasoned€opinion,€it€is€notÐ À5¸.. Ðprecisely€on€point.€€First,€òòRogersóó€obviously€dealt€with€a€different€statute,€with€differentÐ È7À00 Ðprovisions€from€the€one€at€issue€in€this€case.€€Moreover,€the€IDEA€provided€anÐ Ð9È22 Ðindependent€remedial€scheme€whereby€injured€parties€could€seek€relief.€€There€is€noÏsimilar€provision€in€the€FDCA.€€Thus,€while€òòRogersóó€provides€guidance,€it€is€notÐ   Ðdispositive.Ìà 4 àà Œ àOther€jurisdictions€have€reached€differing€results€on€this€issue.€€SomeÏjurisdictions€have€allowed€plaintiffs€to€bring€negligence€claims€per€se€on€FDCAÏviolations.€€In€òòOrthopedic€Equip.€Co.€v.€Eutsleróó,€276€F.2d€455€(4th€Cir.€1960),€theÐ 0(  ÐFourth€Circuit€determined€that€although€the€FDCA€does€not€expressly€provide€a€civilÏremedy€for€injured€consumers,€manufacturers€who€violated€their€statutory€duties€couldÏbe€subject€to€negligence€per€se€claims.€òòAccord:€óó€òòStanton€v.€Astra€PharmaceuticalÐ H@ ÐProds.,€Inc.,óó€718€F.2d€553€(3rd€Cir.€1983);€€òòToole€v.€Richardson„Merrell,€Inc.óó,€60€Cal.Ð PH ÐRptr.€398€(Cal.Ct.App.€1967).Ìà 4 àà Œ àAssuming€òòarguendoóó€that€FDCA€violations€could€be€the€basis€for€aÐ `X Ðnegligence€per€se€action,€we€believe€summary€judgment€was€still€appropriate€in€thisÏcase.€€The€plaintiff€alleges€that€the€defendant€ð ðmarketed,€promoted€and€distributedðð€itsÏproduct€for€the€purposes€which€the€FDA€had€not€approved,€in€violation€of€ðð€360€of€theÏFDCA.€€Section€360€primarily€deals€with€the€duty€of€producers€of€drugs€or€devices€toÏregister€with€the€Secretary€of€State€for€the€state€in€which€certain€establishments€areÏlocated.Ìà 4 àà Œ àIt€is€not€clear€from€plaintiffððs€complaint€which€portion€of€€ðð360€theÏdefendant€is€alleged€to€have€violated.€Plaintiff€may€have€intended€to€allege€violationsÏof€the€Medical€Device€Amendments€to€the€FDCA€and€not€the€general€reportingÏrequirements€of€ðð€360.€€If€so,€this€allegation€is€not€stated€in€the€complaint.€€òòSeeÐ °1¨** ÐóóT.R.C.P.€8.05€(addressing€the€pleading€of€statutory€violations).€€It€is€not€œñgñentirely›€ñgñclear›€how€theÐ ¸3°,, Ðdefendant€failed€to€comply€with€its€statutory€duties.€€The€complaint€recites€severalÏexamples€of€alleged€misconduct€by€defendant.€€Assuming€that€these€instances€wereÏbreaches€of€ðð€360,€summary€judgment,€nevertheless,€was€proper.Ð Ð9È22 Ðà 4 àà Œ àAssuming€defendant€did€breach€ðð€360,€such€breach€was€not€theÏproximate€cause€of€plaintiffððs€injuries.€Assuming€that€the€Appellant€marketed,Ïpromoted€and€distributed€its€product€for€non„FDA€approved€purposes,€Dr.€JeffriesððÏaffidavit€states€that€he€was€fully€aware€of€the€FDA€regulatory€status€of€this€product.€ÏThe€doctor€chose€to€make€an€ð ðoff„labelðð€use€of€the€product.€€He€relied€entirely€uponÏhis€own€expertise€and€experience€in€deciding€whether€and€how€to€use€the€defendantððsÏproduct.€€According€to€his€affidavit€ð ð[m]y€professional€decision€concerning€whether,Ïhow,€or€where€to€use€instrumentation€is€not€determined€by€whether€a€particular€use€ofÏa€particular€drug€or€device€has€or€has€not€been€evaluated€by€the€FDA.ðð€Ìà 4 àà Œ àTo€the€extent€that€the€plaintiffððs€complaint€alleges€improper€marketingÏthrough€the€use€of€certain€literature€and€promotional€campaigns,€€Dr.€Jeffriesðð€affidavitÏestablishes€that€he€was€not€familiar€with,€and€did€not€rely€upon,€any€of€theseÏmarketing€techniques.€€Thus,€assuming€òòarguendoóó,€that€defendant€violated€ðð€360€of€theÐ h` ÐFDCA,€such€violation€was€not,€as€a€matter€of€law,€the€proximate€cause€of€plaintiffððsÏinjury.€Ìà 4 àà Œ àPlaintiff€filed€a€notice€of€deposition€before€summary€judgment€wasÏgranted.€€The€Trial€Court€quashed€the€notice€and€granted€summary€judgment.€PlaintiffÏthen€filed€a€motion€to€alter€or€amend€the€final€judgment€and€as€a€part€of€that€motion,Ïthe€plaintiff€again€attached€an€affidavit€stating€his€need€to€depose€Dr.€Jeffries.€€TheÏTrial€Judge€also€denied€this€motion.Ì€à 4 àà Œ àRule€56.07€of€the€Tennessee€Rules€of€Civil€Procedure€provides:€Ð ¨/ (( ÐÓÓà 4 àà8 Œ àShould€it€appear€from€the€affidavits€of€a€party€opposing€theÏmotion€that€such€party€cannot€for€reasons€stated€present€byÏaffidavit€facts€essential€to€justify€the€opposition,€the€court€mayÏrefuse€the€application€for€judgment€or€may€order€a€continuance€toÏpermit€affidavits€to€be€obtained€or€depositions€to€be€taken€orÏdiscovery€to€be€had€or€may€make€such€other€order€as€is€just.Ð Œ Ð Œ Ð  Ðà 4 àÌÓÓIn€this€case,€the€Trial€Court€did€not€abuse€its€discretion€in€refusing€to€allow€furtherÐ Ì8Ä11 Ðdiscovery.€€Defendant€raised€the€learned€intermediary€defense€in€its€answer.€€OverÏseventeen€months€passed€before€the€defendant,€relying€on€Dr.€Jeffriesðð€affidavit,Ïmoved€for€summary€judgment.€€The€plaintiff€waited€until€the€day€argument€was€to€beÏheard€on€the€motion€before€giving€formal€notice€that€he€wished€to€take€Dr.€JeffriesððÏdeposition.€€This€was€some€seventy€days€after€the€summary€judgment€motion€had€beenÏfiled.€€Under€these€circumstances,€we€conclude€the€Trial€Judge€did€not€abuse€hisÏdiscretion€in€denying€this€motion.€Ìà 4 àà Œ àFinally,€plaintiff€contends€that€the€Trial€Court€erred€in€denying€his€thirdÏproposed€amendment€to€his€complaint.€€Plaintiff€moved€to€amend€for€a€third€time€onÏJune€30,€1997.Ìà 4 àà Œ àRule€15.01€of€the€Tennessee€Rules€of€Civil€Procedure€provides:Ìð ðA€party€may€amend€his€pleadings€once€as€a€matter€of€course€at€any€time€before€aÏresponsive€pleading€is€served€.€.€.€[o]therwise€a€party€may€amend€his€pleadings€only€byÏwritten€consent€of€the€adverse€party€or€by€leave€of€court€.€.€.ðð€€Although€permission€toÏamend€should€be€liberally€granted,€the€decision€is€ð ð€within€the€sound€discretion€of€theÏtrial€court,€and€will€not€be€reversed€unless€abuse€of€discretion€has€been€shown.ðð€ÏòòWelch€v.€Thuan,óó€882€S.W.2d€792,€793€(Tenn.App.€1994).€€Factors€the€trial€courtÐ ˆ'€  Ðshould€consider€when€deciding€whether€to€allow€amendments€include€ð ðundue€delay€inÏfiling;€lack€of€notice€to€the€opposing€party;€bad€faith€by€the€moving€party,€repeatedÏfailure€to€cure€deficiencies€by€previous€amendments,€undue€prejudice€to€the€opposingÏparty,€and€futility€of€amendment.ðð€òòMerriman€v.€Smithóó,€599€S.W.2d€548,€559Ð ¨/ (( Ð(Tenn.App.€1979).Ìà 4 àà Œ àIn€this€case,€plaintiff€sought€to€amend€his€complaint€to€includeÏallegations€that€one€of€the€nuts€holding€the€screws€in€his€back€was€loose€and€that€allÏfour€of€the€screws€became€loose€within€his€spine.€€The€report€upon€which€thisÏamendment€was€based€is€dated€August€8,€1995,€yet€the€appellant€did€not€attempt€toÐ Ð9È22 Ðutilize€it€before,€even€when€the€defendant€moved€for€judgment€on€the€pleadings.€€TheÏplaintiff€attempted€to€use€the€operative€report€as€evidence€that€ð ð[t]he€TSRH€spinalÏsystem€and€the€pedical€screws€in€particular€were€unreasonably€dangerous€andÏdefective€.€.€.€ð ð€€The€alleged€looseness€in€the€screws,€however,€was€observed€only€afterÏthe€product€was€being€dismantled,€not€while€it€was€implanted.€€The€screws€wereÏobserved€to€be€loose€only€after€the€rods€and€connectors€were€removed.€€There€isÏnothing€in€the€operative€report€to€establish€that€any€of€the€screws€became€loose€whileÏin€the€plaintiffððs€back,€only€that€one€of€the€nuts€was€loose.€€Ìà 4 àà Œ àFor€the€foregoing€reasons,€we€conclude€the€Trial€Court€did€not€abuse€itsÏdiscretion€in€denying€this€amendment.Ìà 4 àà Œ àWe€affirm€the€judgment€of€the€Trial€Court€and€remand€with€cost€of€theÏappeal€assessed€to€the€appellant.ÌÌÌÓÓÌà 4 àà Œ àà ä àà < àà ” àà ì àœ____________________ñhñ____ñhñ__›Ìà 4 àà Œ àà ä àà < àà ” àà ì àHerschel€P.€Franks,€J.ÌÌÌCONCUR:ÌÌÌÌÌÌ___________________________ÌHouston€M.€Goddard,€P.J.ÌÌÌÌÌÌ___________________________ÌDon€T.€McMurray,€J.ÌÌ