File Na me: 11a0609n.06 NOT RECOMMENDED F OR FUL L -TEXT PUB L I CATI ON

No. 09-6273 UNITED STAT ES COURT OF AP P EALS FOR THE SI XTH CI RCUI T TRI NA EMERSON, substituted on behalf of Tim Crews, de cea sed, Plaintiff-Appellant,

v. N O V A R T I S P H A R M A C E U T I C A L S CORPOR ATI ON, Def endant- Appellee

. ON APPEALFROM THE UNI TED STATES DI STRI CT COURT FOR THE MI DDL E DI STRI CT OF TEN

NESSEE

/ Be fore : MARTI

N, B OGGS, and COOK , Circuit J udg es. BO YCE F. MARTI

N, J R., Circuit J udg e. Trina Emerson appea ls the district c ourt’s g rant of summary judgme nt in favor of Novar tis Pharmac euticals Corporation. The district court held that Emerson failed to rebut Florida ’s statu t o ry p resumption that beca use Z ometa and Are dia wer e proper ly approve d by the Food and Drug Ad m i n i s t ration, they wer e not defe ctively dang erous. Whil e the voluminous rec ord may have contained some evidenc e that might have cre ated a materia l question of fac t suffi ci en t t o rebut this presumption and defe at Novar tis’s motion for summary judgme nt, Emerson failed to specific ally identify and arg ue those fac ts to the district court. Be cause the only arg uments Emerson made wer e not rele vant to rebutting this statutory presumptio n, we AF F IRM the district court’s g rant of summar y judgme nt.No. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 2 I. This case arises out of a series of lawsuits filed by individuals who develope d osteonec rosis of the jaw, a sever e bone disease aff ecting the jaw, alleg edly as a result of taking Z ometa and Are dia. Z ometa and Are dia are presc ription bisphosphonate drug s produce d b y No v ar tis that are g iven 1 intravenously most often to patients with canc erous conditions. The drug s are eff ective at preve nting patholog ical fra cture s, spinal cord compre ssion, and other bone pains. Although the Food and Drug Administration approve d both drug s, many individuals claim to have develope d osteonec rosis of the jaw as a result of rec eiving this medication. Osteonec rosis of the jaw results in the g ums being eate n

awa y until the bone is ex posed. Emerson is the surviving adult daug hter and persona l repr esenta tive of Tim Randall Crews, who filed suit ag ainst Novar tis afte r developing osteonec rosis of the jaw. Crews initially filed this lawsuit in the Middle District of Florid a , a n d th e J udicial Panel on Multidi strict L itigation transfe rre d the ca se to the Middle District of Te nnessee for c onsolidated pretr ial proce eding s. The district court g rante d Novar tis’s motion for summary judgme nt on the basis of Florida ’s g overnme nt-rules defe nse, which provides a rebuttable presumption that cer tain products that have

r e c e ive d proper reg ulatory approva l are not defe ctively dang erous. Although the distric t c o u r t d e n ie d Novar tis’s litigation-wide motion for summary judgme nt, it found that Emerson ha d n o t r e b utted this presumption beca

use her only arg uments were pree mpted.

II.

Bisphosphonate s are a cla ss of drug s that derive the ir name f rom their chemica l struc ture, 1

3 which conta ins two phosphonate g roups (PO ) cova lently bonded to a c arbon a tom.No. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 3 A. Summ ary Judgm ent Standard. “We revi ew t h e district court’s g rant of summary judgme nt de novo.” Stansberry v. Air W isconsin Airlines Corp. , – F.3d —, No. 09-2499, 2011 WL 2621901, at *3 (6th Cir. J uly 6, 2011) (citing Bentkowski v. Scene Magazine , 6 3 7 F.3d 689, 693 (6th Cir. 2011). Summary judgme nt is appropr iate wher e the pleading s, depositions, answe rs to interrog atories, admissions on file, and aff idavits show “that there is no g enuine dispute as t o any materia l fac t and that the movant is entitled to a judgme nt as a matter of law.” Fe d. R. Civ. P. 56(a)

. “The moving party has the initial burden of proving that no g enuine issue of materia l fa ct exis ts,” and the court must draw all

rea sonable infere nces in the light most favor able to the nonmoving party

. Vaughn v. Lawrenceburg Power Sys. , 269 F.3d 703, 710 (6th Cir. 2001)

. When a motion for summary judgme nt is proper ly made and supported and the nonmoving party fails to respond with a showing sufficie nt to establish

an essential element of its case , summary judgme nt is appropr iate. See Celotex Corp. v. Catrett , 477 U.S. 317, 322-23 (1986). Rule 56 place s an aff

irmative duty on the nonmovant to cite to “par ticular parts of materia ls in the rec ord” to establish that a particula r fac t c annot be supported or is g enuinely disputed. Fe d. R. Civ. P. 56(c) (1); see Chicago Titl e Ins. Corp. v. Magnunson , 487 F.3d 985, 995 (6th Cir. 2007). District courts need not independe ntly comb throug h the rec ord and establish that i t i s b ereft of a g enuine issue of mater ial fac t before g ranting summary judgme nt. Chicago Tit le Ins. , 487 F.3d a t 995; Street v. J

.C. Bradford & Co. , 886 F.2d 1472, 1479- 80 (6th Cir. 1989). Alt houg h we r eview

a district court’s decision g ranting or deny ing summary ju d gm en t d e n ovo, we g ener ally will notNo. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 4 consider fac ts that wer e not broug ht to the district court’s attention. Chicago Titl e Ins. , 487 F.3d at 995; Guarino v. Brookfield Twp. Trs. , 980 F.2d 399, 404 ( 6th Cir. 1992). B. Whether Em erson Rebutted the Statuto r y P r e s um pt io n That Zom eta is Not Defect ively Dangerous. Florida has adopted a g overnme nt-rules defe nse, which cre ates a rebuttable presumption that

cer tain products are not defe ctive or unrea sonably dang er o u s . Fl a. Stat. Ann. § 768.1256 (West 2010). The sta tute provides that: (1) I n a product liability action broug ht ag ain s t a m an u fac turer or seller for harm alleged l y cause d by a product, there is a rebuttable presumption that the product is not defe ctive or unrea sonably dang erous and the manufa cture r or seller is not liable if, at the time the specific u n i t of the product was sold or delivere d to the initial purcha ser or

user, the a spect of the product that a lleg edly cause d the har

m: (a) Compli ed with fede ral or state codes, s t at u t es , rules, reg ulations, or standards rele vant to the eve nt causingthe dea th or injury ; (b) The cod es , s tatutes, rules, reg ulations, or standards are desig ned to preve nt the ty pe of ha rm that alleg edly

occur red; a nd (c) Compli ance with the codes, statutes, rules, reg ulations, or st andar ds is require d as a c ondition for selling or distributing the produc t. The parties do not dispute that Novar tis is entitled to this presumption t hat Z ometa and Are dia are not de fec tive or unrea sonably dang erous. What this presumption actua lly entails is a

nother story

. Florida ’s statute has not y et been thoroug hly interpre t ed , and the contours and opera tion of the presumption are still larg ely unsettled. Howeve r, the district court did not need to interpre t this are a of state law beca

use it held that Emerson’s only arg uments wer e pree mpted. We ag ree and also do not need to interpr et this statute or deter mine how the pre sumption operates.No. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 5 I n her brief to the district court, Emerson arg ued that Novar tis was not entitled to the benef it of Florida’s st atutory presumption beca use i t had defraude d the Food and Drug Administration to g ain reg ulatory appro v a l. H o w e v e r , this ty pe of “fr aud-on- the-a g ency ” claim is pree mpted by fede ral law. See Buck

man Co. v. Plaintif

fs’ Legal Comm. , 531 U.S. 341, 347 (2001). There fore , reg ardle ss of the intricac ies o f Fl o ri d a’s statutory presumption, this arg ument is not sufficie nt to rebut the presumption that Z ometa and A redia are not defe ctive or unr easona bly dang erous. Whil e Emerson attempted to incorporate fac ts and arg uments from other case s and litigationwi d e fi l i n gs in this multidi strict litigation, she failed to do so with any particula rity or develop arg uments as to how these materia ls bore on Florida ’s statutory presumption. I n her briefing befor e the district court, Emerson beg an by stating that she adopted “the memoran d u m s of law and fac t, expert witnesses’ testimony and repor ts, and the entirety of the case wide discovery and pleading s,

as if eac h wer e specific ally set forth in this Memorandum.” Although a party may incorporate other documents by ref

ere nce, and there are circ umstances when it may be expeditious and appropr iate to do so, parties still must comply with their duties under Rule 56. S p ecif ically , a party opposing a motion for summ ary judgme nt must “cit[e] to particular par ts of materia ls in the rec ord,” or show that the fac ts cited by the movant do not establish the absenc e of a g enuine dispute. Fe d. R. Civ. P. 5 6 (c )( 1 )(A)

. At the time Emerson filed her brief in district court, the multidi strict litigat i o n contained 2,530 separ ate docket entries. Many of these entries contained numerous exhibi ts, and we cannot beg in to specula te how many pag es Emerson’s brief attempted to incorpora te. I n contra st to the require ments in Rul e 56, Emerson’s attempt to incorporate this mountain of evidenc e byNo. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 6 ref ere nce fails to identify particula r documents in the rec ord, let alone “par ticular parts of materia ls in the rec ord.” Ba sed on the district court’s other decisions in this litigation, it appea rs that there might have been evidenc e in the rec ord sufficie nt to rebut the presumption and cre ate a materia l question of fac t

as to whether Z ometa is dang erously defe ctive. Howeve r, it was not the district court’s duty to trac k down those fac ts. The distric t c o u r t d e n ie d N o v a

r tis’s litigation-wide motion for summary judgme nt, which was made on the basis that it had adequately war ned of t h e ri s k, holding that there wer e “a my riad of fac tual issues.” Additionally , i n a later case that is part of the same Multidi strict L itigation, the district court denied a motion for summary judgme nt, holding that, while Novar tis is entitled to Fl o ri d a’ s s tatutory presumption that Z ometa and Are dia are not defe ctive, the plaintiff identified, in that case , evidenc e in the rec ord that cre ated a materia l question of fac t as to whether the presumption had been rebutted. 2010 WL 813459, at *1-2 (M.D. Tenn. Marc h 3, 2010). Specifica lly , the district court distinguished its ear lier ruling in Emerson’s cas e, ex plaining that Emer s o n had “ar g ued solely that any FDA approva ls of Are dia or Z ometa wer e obtained improperly .” Id. (commenting that the Emerson “ruling was limit ed to t h e arg ument asser ted by [Emerson] and, ther efor e, is not prec lusive of these Plaintiffs’ c laims”). The district court’s othe r decisions in these rela ted case s sug g est that it might have decide d this issue differ ently if it had been prese nted with briefing that identified these fac tual disputes with particula rity and contained specific citations to p ar t i cu l ar portions of the rec ord instead of pree mpted arg uments. Howeve r, it was Emerson’s job to identify this evidenc e and cra ft these arg uments and not the district court’s.No. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 7 Be cause she failed to do so, the district court proper ly g rante d summary ju d gm en t in favor of Novar tis. Particularly beca

use the district court was fac ed with a larg e number of these case s, eac h with its own complicated leg al and fac tual issues, the distric t co u rt cannot be faulted for not doing the work of pla intiff’s counse l and underta king a detailed revie w of the e ntire re cord. A district court is not require d to “sea

rch the entire rec ord to establish that it is bere ft of a g enuine issue of materia l fac t.” Street , 886 F.2d 1472, 1479- 80. “[J ]udges a re not like pig s, hunting for truffle s” that mig ht be buried in the rec ord. United St a t es v. Dunke l , 927 F.2d 955, 956 (7th Cir. 1991). The district
court considere d the arg uments that Emerson made and deter mined that those argu m en t s we re pree mpted and, there fore , insufficient to rebut the statutory presumption. The district court did not need to independe ntly consider whether there wer e any other arg uments or fac ts that Emerson could have cited to that mi gh t h av e been sufficie nt to defe at Novar tis’s summary judgme nt motion. Simi larly , the material s t h at E m erson attempted to incorpora te by ref ere nce also do not rebut the statutory presumpt i o n b eca use she failed to specific ally identify any thing in those materia ls or explain how those materia ls rebutted Florida ’s statutory presumption. T h er ef o re , based on the arg uments that Emerson prese nted to the district court, it did not err by g ranting summary judgme nt in favor of

Novar tis. III. Emerson’s primary argum en t t o overc ome the Florida statutory presumption and defe at Novar tis’s motion for summary judgme nt was bas ed o n a p ree mpted fra ud-on-the- ag ency claim. Whil e Emerson asser

ted that she was incorporating ot h er materia ls, this blanket incorporationNo. 09-6273

Emerson v . Novartis Pharm. Corp. Pag e 8 wit h o u t s p ec ifically identify ing any individual fac ts or how they opera te in conjunction with the presumption is insufficient to def eat Nova rtis’s motion for summary judgme nt. The dist rict court need not identify arg uments and fac ts that she failed to raise in her briefing

. Acc ording ly , the district court’s g rant of summar

y judgme nt in favor of

Novar tis is AF F IRMED

.