NOT RECOMMENDED F OR FUL L -TEXT PUB L I CATI ON File Na me: 12a0874n.06 No. 11-3726 UNI TED STATES COURT OF A PPEAL S FOR THE SI XTH CI RCUI T

RACHEL KRUMPEL BECK, Plaintiff-Appellant,

v. BREG, I NC., et al., Def endants-A

ppellees. )

) ) ) ) ) ) ) ) ) ON APPEAL FROM THE UNI TED STATES DI STRI CT COU RT FOR THE SOUTHERN DI STRI CT OF OH I O

Before: G UY and DONALD, Circuit Judges, and O’MEARA, D istrict Judge. *

BERNICE BOUIE DONALD, Circuit Judge

. This appea l arises from a product liability action ag ainst medical device manufa cture r Br eg , I nc., for injuries alleg edly resulting from Rache l Krumpelbe ck’s use of a Br eg pain pump. Krumpelbe ck’s complaint asser ted seven claims ag ainst Br eg : (1) strict liability - desig n defe ct; (2) strict liability - war ning defe ct; (3) strict liability

- nonconfor

mance with repr esenta tions; (4) neg lige nce; (5) brea ch of express war ranty ; (6) brea ch of implied war

ranty ; and (7) neg lige nt misrepre sentation and fra ud. Br eg filed a motion for summary judgme nt in which it a

rg ued that it wa s rea sonably unawa re of the risk of injury that Krumpelbe ck sustained, and there fore , that it had no duty to war n. Alterna tively , Br eg arg ued that Krumpelbe ck could not show that a failure to war n cause d her injury

. The district court g rante d Br eg ’s motion for

The Honora

ble J ohn Corbett O’Mea

ra, United States District Court for the Easter n District * of Michig an, sitting by

desig nation.No. 11-3726

Krumpelbeck

v. Breg summary judgme nt and dismiss ed Krumpelbe ck’s complaint. Krumpelbe ck ti me ly a p p eale d. Whil e

we find n o er ro r i n the district court’s dismiss al of Krumpelbe ck’s common law claims and her statutory claim of nonconfor mance with repr esenta tions, we find that, construing the evidenc e in the light most favor able to Krumpelbe ck, there are g enuine disputes of fac t that could allow a rea sonable jury to find in her favor on her statutory claims of defe ctive desig n and inadequa te war ning or instructi o n . Acc ording ly , we AF F IRM in part, REVERSE in part, and REMAND for further proce eding s. I. BACKG ROUND On Marc h 3, 2005, Plaintiff-Appellant R achel Krumpelbe ck, then sevente en y ear s old, underw ent arthrosc opic surg ery on her shoulder. Her surg eon, Dr. Paul Favorito, used a Br eg pain pump device to administer a local anesthe tic to Krumpelbe ck’s shoulder for four day s following her surg ery . Dr. Favorito inserted the pain pump cathe ter direc tly into Krumpelbe ck’s shoulder joint to deliver the presc ri b ed pain medication. I n the months following her surg ery , Krumpelbe ck experience d extreme pain, and worsening stiffness, clicking , and popping in he r shoulder joint. I n Dec ember 2007, Krumpelbe ck was diag nosed with g lenohumera l chondroly sis, a painful condition involving the perma

nent dest ru ction of articula r car tilage in the shoulder joint. Acc ording to her doctor, Krumpelbe ck’s prog nosis is poor, and she will l ikely require sever al complete shoulder repla ceme nts during he r lifetime. On Fe bruar

y 6, 2009, Krumpelbe ck filed a seve n -c o u n t complaint ag ainst Br eg , the manufa ctu

r e r o f th e p a in p u

mp; Orthofix I nterna tional NV, Br eg ’s pare nt corpor ation; and Advanc ed

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Krumpelbeck

v. Breg Tec hnology , a wholesale distributer of medical equip m en t , i n cludi ng the Br eg pain pump. The 1 complaint alleg ed strict liability for defe ctive desig n, inadequa te war nings, and failure of the pump to confor m to repr esenta tions. The complaint also asser ted claims for neg lige nce, brea ch of express and implied war

ranty , neg lige nt misreprese ntation, and fra ud. On October 15, 2010, Br eg filed a motion for summ ary j udg ment, arg uing that at t he ti me of Krumpelbe ck’s surg ery neither Br eg nor Krumpelbe ck’s trea ting phy sician had knowledg e of any risk associate d with the continuous intra-a rticular infusion of anesthe tic and, in particula r, any link to chondroly sis. Bre g also arg ued that all common law c laims Krumpelbec k asser ted wer e bar

red b y t h e April 2005 amendment to the Ohio Products L iability Act (“O PL A”) , which expressly abrog ated all common law cause s of action sounding in products liability

. Krumpelbe ck fil ed a

re s p o nse under seal on November 5, 2010, arg uing that there wer e disputed fac ts reg ardi n g t h e fore seea bility of harm that prec luded summ ar y j u d gm en t. On November 22, 2010, Br eg filed a reply

. On Dec ember 2, 2010, afte r the pleading s wer e fully ripe for revie w, Krumpelbe ck filed as a stand-a lone docke t entry the expert repor

t of Dr. S uzanne P arisian, which was take n in a similar pain-pump case pending in another district

. On December 23, 2010, seven wee ks afte r filing her memorandu m, Krumpelbe ck filed an additional 2,827 pag es of deposition transcr ipts, also as independe nt docket entr ies, which include d the deposition of Dr. Par isian.

Orthofix and Advance d Tec hnology are no longe r par

ties to the case

. 1 - 3 -No. 11-3726

Krumpelbeck

v. Breg On Dec ember 27, 2010, the district co urt enter ed an order g ranting Br eg ’s motion for summary judgme nt. Krumpelbeck v. Breg, Inc. , 759 F. Supp. 2d 958 (S.D. Ohio 2010). The court ag ree d that “[a]s of the time of Plaintiff’s surg ery , the now-purpor ted association betwee n chondroly sis and anesthe tic infusion in the shoulder joint was unknown to Def endant, and, indeed,
to the entire scientific community ,” and “[t] here fore , Def endant brea ched no dut y , an d t he [pain pump] was not defe ctive for inadequa te warning s or i nstructions.” Id

. at 9 7 4

. The court reje cted Krumpelbe ck’s desig n defe ct claim for the same rea son—beca use there was no evidenc e that Br eg knew or should have known of t h e ri s k , Krumpelbeck could not show that “the fore seea ble risks

as sociated with [t he product’s] desig n . . . exceede d the benef its.” Id. at 975. The d i s t ri ct co u rt dismiss ed Kr

umpelbeck’ s complaint in its entirety

. O n Ja n u a r y 1 7 , 2 0 1 1 , K

rumpelbec k filed a motion to alter and/or obtain relief from judg me n t. I n the motion, counsel posited that, for some r e a s o n “ n o t k n o w n to Plaintiff,” the Court “over looked” Dr

. Pa r is ia n ’ s te s ti mony in g ranting Br eg ’s motion for summary judgme nt. Krumpelbe ck arg ued that Dr. Parisian’s repor

t a nd deposition “dire ctly state[] that there was ample medical literature and other evidenc e in exis tence at the time of Plaintiff’s surg ery that Br eg knew or should have known of the risk of harm from using pain pumps inside the joint space prior to Marc h 2005.” Krumpelbe ck urg ed the district court to “now consider these documents and expert testimony as they are repr esenta tive of that which will be prese nted at the trial of this matter

. . . and it direc tly addre sses those omissions in the rec ord that led the Court to g rant the Def endant’ s motion for sum m ar y j u d gm en t.” Krumpelbe ck also arg

ued for the first time that her common law claims wer e not pre- empted by the OPL A bec ause he r injury occur red be fore the ef

fec tive date of

the April 2005 ame ndment. - 4 -No. 11-3726

Krumpelbeck

v. Breg T h e district court denied Krumpelbe ck’s motion, citing Southern Dis tr ic t o f O h io L o c a l Ru le 2 7.2(d), which provides that “all evidenc e then available shall be discussed in, and submitt ed no later than, the primary memorandum of the party rely ing upon such ev i d en ce.” (empha sis added)

. I n light of that rule, and g iven the fac t t h at Dr

. Parisian’s deposition and repor t wer e not “new ly discovere d evidenc e,” the court stated that it would not consider Dr. Parisian’s repor t or deposition,

nor any of the other late-f iled documents that Krumpelbe ck submitt ed. The court pointed out that, apar t from being untimely , Krumpelbe ck’s “supplementa ry ex h i b i t s ” wer e filed without any explanation as to how they supported her memorandum in opposition. The district court stated that it could not “infe r arg uments from exhibi ts that are not ref ere nced in the pleading s nor be expected to analy ze 27,000 [ sic] page s of facts without any direc tion,” and chastised counsel for failing “to sy nthesize those fac ts and prese nt them to the Court in a compre hensive fashion.” The district court made clea r, howeve r, that even if it wer e to consider these documents, they wer e insufficient on their fac e to establish the existence of a triable issue.
Krumpelbe ck’s motion soug ht relief pu rs u an t to both Rule 59(e) and Rule 60(b) of the 2 Fe dera l Rules of C ivil Procedur e. Rule 59(e) was amended effe ctive Decembe r 1, 2009, to allow parties twent y -e i gh t d ay s afte r entry of judgme nt to file a motion to alter or amend. The district court, citing an older version of Rule 59(e) , err oneously stated that Krumpelbe ck’s motion to a lter or amend was untime ly beca use it was filed more than ten day s afte r the entry of judgme nt. T h e r e f o r e , the court only considere d Krumpelbe ck’s motion under the much highe r s ta n d a r d r e q u ir e d for g ranting a Rule 60(b) motion for relief from judg ment. Although the district court undeniably err ed in stating that Krumpelbe ck’s Rule 59(e) motion was untimely , Br eg corr ectly notes t h at Kr u m pelbec k’s counsel has not prese nted this issue for re v i ew i n t he prese nt appea l, which makes assig nments of err or only with reg ard to the distr i ct court’s summary judgm en t an aly sis. Acc ording ly , we limit our revie w to those issues. We note, howeve r, that Krumpelbe ck is not prejudice d by this limit ation, as her Rule 59(e) motion essentially raised the same objections to the district court’s summary judgme nt analy sis that Krumpelbe ck now raises on a

ppeal. - 5 -No. 11-3726

Krumpelbeck

v. Breg II. ANALYSIS On appea l, Krumpelbe ck arg ues that the district court applied t h e wr o n g v ersion of the OPL A, there by err oneously deter mining that her common law claims wer e barr ed by the April 2005 amendments to the Act. Krumpelbe ck also arg ues that the district court err ed in dismiss ing without discussion o r an aly sis cer tain claims that wer e pleade d in her complaint but which Br eg did not ad d re ss in its motion for summary judgme nt. Finally , Krumpelbe ck maintains that sum m ar y judgme nt was improper on her claims of defe ctive desig n, defe cts due to i nadequate war ning or instruction, and defe cts due to nonconfor mance with repr esenta

tions beca use she put forth sufficie nt evidenc e fr om which a r easona ble jury could find in her f

avor. A. Standard of

revie w W e revie w a district court’s order g ranting summary judgme nt de novo. Int’l Union v. Cummins, Inc. , 434 F.3d 478, 483 (6th Cir. 2006). A motion for summary judgme nt should b e g rante d if the evidence be fore the cour t shows that there is no dispute of mate rial fa ct and that the
movant is entitled to judgme nt as a matter of law. Fe d. R. Civ. P. 56(a) ; see Celotex Corp v. Catrett , 477 U.S. 317, 322 (1986). The moving party has the burden o f s h o wi n g t h e absenc e of g enuine disputes over fac ts which, under the substantive law g overning the issue, might aff ect the outcome of the action. Celotex , 477 U.S. at 323. The part y opposing the motion may not rest upon the alleg ations set forth in the pleading s; r ather , it must show that there is some evidenc e, more than a

mere scintilla, establishing a g enuine issue for trial. See Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248 (1986). B. App licable version of th e OP LA - 6 -No. 11-3726

Krumpelbeck

v. Breg The district court d i d n o t addre ss the merits of Krumpelbe ck’s arg ument that the preamendm ent version of the OPL A—the version in eff ect at the time of her Marc h 2005 surg ery —should gove rn this case rathe r t han the post-amendment version in eff ect a t the time her

cause of action arose . Be cause Krumpelbe ck failed to timely raise this arg ument below, we find no

err or in the district court’ s dismis sal of Kr umpelbeck’ s common law cla ims. C. Notic e of risk The thrust of Br eg ’s mot i o n for summary judgme nt, and the primary basis on which the district court g rante d the motion, was that Br eg was rea sonably unawa re of the risk of chondroly sis
at the time of Krumpelbe ck’s surg ery in Marc h 2005 and, thus, had no duty to war n of this risk. On appea l, Krump el b eck arg ues that there is a g enuine dispute of fac t as to whether the information available to the scientific community as of Ma rch 2005 w as suffic ient to put Bre g on notice of the risk of harm from the intra-a rticular use of its pain pumps. She also contends that the FDA’s repe ated ref

usal to c lear Br eg ’s device for orthopedic and/or intra-a rticular use should have place d Br eg on notice of a risk of harm of the nature that Krumpelbe ck suffe red. Moreove r, Krumpelbe ck points out that sever al of her claims do not have a notice require ment—in particula r, her claims for strict liability for nonconfor mance with repr esenta tions, bre ach of express war ranty , and brea ch of implied war

ranty

. Thus, to the ex t en t t hat the district court g rante d summary judgme nt on these claims based on B reg ’s lack of notice, Kr

umpelbeck a

rg ues that the c ourt err ed. I t is clea r from her complaint that Krumpelbe ck asser ted two distinct c ateg ories of claims: those that require notice of a fore seea ble risk and those that ar e p re m i s ed on a materia l

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Krumpelbeck

v. Breg misrepre sent at i o n. Having deter mined that Krumpelbe ck’s common law claims are barr ed, we 3 addre ss the merits of Krumpelbe ck’s arg uments only with respe ct to those claims that are cog nizable under the OPL A.

1. Claim s that includ e a notice requirem ent The claims that Krumpelbe ck asser ted in her complaint that require notice of a risk of harm befor e liability can be imposed are : strict liability for defe ctive desig n; strict liability for inadequa te

war ning or instruction; and neg lige nce. Of these claims, two have statutory counter parts under the OPL A as am en d ed : p ro ducts defe ctive in desig n or formulation, found in Ohio Revised Code § 2307. 7 5 , an d p roducts defec tive due to inadequa te warning or i nstruction, found i n Ohio Revised Code § 2307.76. Be cause g enuine disputes of fac t e x ist that could allow a rea sonable jury to find 4 for Kr umpelbeck on the statutory claims, we f

ind that summary

judgme nt was not appropr iate. a. Appli cable OP LA provision s A product is defe ctive in desig n or formulation if t h e fo re s ee able risks associate d with its desig n or formulation exceed the benef its. Ohio R ev . C o de § 2307.75(A). The fore seea ble risks associate d with a product’s desig n are deter mined by considering fac tors, including, but not limit ed to, th e l ikely awa

rene ss of product users of the risk of harm; the likelihood of the desig n or

Krumpelbe ck also corr ectly observe s that the di strict court’s or der f ocused solely on the 3 former cate g ory of claims (those that require n o t i ce o f a fore seea ble risk) and did not addre ss the merits of her claims based on a materia l misre prese ntation, de spite g ranting summary judgme nt in favor of B reg on those claims. The third claim, neg lige nce, is a common law claim that has been abrog ated by the OPL A. 4

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Krumpelbeck

v. Breg formulation to cause harm in light of the product’s intended or rea sonably fore seea ble uses; and the

ex tent to which the desig n or formulation is more dang erous than a reasonably prude n t co n s u m er would expect when used in a n intended or rea sonably fore seea ble manner . Id. at § 2307.75(B ). A product is defe ctive due to inadequa te warning or i nstruction if “the manufac turer knew, or in the exercise of rea sonable car e, should have known about a risk that is associate d with the product” and the manufa cture r “fa il ed t o provide the war ning or instruction that a manufa cture r exercising

rea sonable c are would have pr ovided conc erning that risk.” Id. at § 2307.76(A) (1).

b. Medical literat ure Acc ording to Br eg , Krumpelbe ck’s cla i m s “r est on a fundame ntally flawe d premise: that Br eg knew or rea sonably should have known that continuous administration of anesthe tic in the joint space could cause chondroly sis.” I n its motion for summ ary judgme nt, Bre g aver red tha t “no one in the medical scienc e community as of Marc h 2005 had hy pothesized that continuous intra-a rticular infusion o f anesthe tic into the shoulder joint could cause chondroly sis.” Br eg further arg ued that “[t] his premise, still hotly disputed today , had not a n iota of support in the collective literature and knowledg e of the medical scientific community when [Krumpelbeck’ s] shoulder surg ery was perf ormed.” 5

I n fac t, it is undisputed that it was not until Marc h 23, 2006—one y ear afte r Krumpelbe ck’s 5 surg ery —at t he annual meeting of t he American Acade my of Orthop ed i c Surg eons t hat Dr. Br ent Hanse n discussed, for the first time, the development of chondroly sis a nd a possible connec tion to pain pumps use d in the intra-a rticular space . I n J uly 2007, Dr. Hanse n and his c olleag ue Dr. Be ck published t h e fi rs t p eer revie wed article discussing the possible link betwee n pain pumps and chondroly sis. - 9 -No. 11-3726

Krumpelbeck

v. Breg Although liability based on defe ctive desig n involves balanc ing the fore seea ble risks ag ainst the purported benef

its, Br eg ’s arg ument fails to acknow ledg e the many statutory fac tors that a court must consider in deter

mining what those fore seea ble risks are . See Ohio Rev. Code § 2307.75(B ). One of these fac tors is the so-ca lled “consume r expectation” te st, which consider s “[t] he extent to which [t he product’s] desig n or formulation is more dang erous than a rea sonably prudent consumer would expect when used in an intended or rea sonably fore seea ble manner .” Id. at § 2307.75(B )(5)

. This is the p ri m ar y b as is on which Krumpelbe ck arg ues that Br eg ’s pain pump was defe ctive in desig n. The district court’s order makes only passing re fe re n ce to this test, descr ibing it as “Plaintiff’s theory ” of defe ctive desig n. The district court appar ently did not associate the consumerexpectation test with the OPL A; it found that Krumplebe ck’s “desig n-def ect claims fail for the same

rea son [she] cannot prove her war nings claims - there is no evidenc e that [Breg ] knew or had rea son to know of a purported risk associate d with intra-a rticular infusion of anesthe tics.” The focus of the

co nsumer-e x pecta tion test, howeve r, is not the risks known to the manufa cture r, but rathe r, th e consumer’ s understanding and appre ciation of the dang ers associate d with use of the product. Be cause the district court did not discuss the statutory fac tors listed in § 2307.75(B ), including the

consumer- expectation test, we find that it misapplied the law in deter mining the “for esee able risks” for the pur

poses of Kr

umpelbeck’ s claim for de fec tive desig n. Mo re o v er , we find that the di strict court’s order frame s the i ssue t oo narr owly

. Whil e the medical literature as of Marc h 2005 was insufficient to put Br eg on notice of the risk of chondroly sis specific ally , Krumpelbe ck pointed to numerous article s and published studies prior to that time that found a link betwee n infusion of chemica ls into the joint space and harm of the same g ener al nature - 10 -No. 11-3726

Krumpelbeck

v. Breg

as that Krumpelbe ck suffe red—da mag e and destruction of the car tilage

. The district court corr ectly noted that this literature does not establish that Br eg had actua l notice of the risk of chondroly sis prior to he r surg ery . A rea sonable jury could conc lude, howeve r, that it was sufficie nt to put B reg

on notice of the risk of harm to the car tilage g ener ally when its device was used to inject anesthe tics direc tly in the joint space . Simi larly , the literature could be sufficie nt to put a rea sonable manufa cture r on notice of the nee d for testing to expl ore the potential risks inherent in such use

. I n reje cting this evidenc e, the district court made an impermissible fac tual deter mination that the evidenc e was not sufficie nt, stating that it was “par ticularly troubled by [Krumpelbeck’ s] failure
to provide any expert tes t i m o n y supporting counsel’s bald conclusion that there was rele vant literature available prior to Marc h 2005.” I t is u n cl ea r why —at least, at the summary judgme nt stag e—the court would require Krumpelbe ck to produce an expert to testify that there was rele vant literature when Krumpelbe ck produce d, instead, the literature itself. Whil e a trial expert will almost

cer tainly be require d to explain th e s i g nificanc e of the literature to a jury , the literature itself is evidenc e, more than a mer e scintilla, sufficie nt to establish an issue for tria l.

c. F DA As additional support for her position, Krumpelbe ck arg ues that there wer e other events and circ umstances that put Br eg on notice of the risk of harm—in part i cular , the Food and Drug Administration’s (“F DA”) ref usal to app r o v e B r e g ’ s p a in pumps for orthopedic and/or intra-a rticular

use. The FDA requir es m an ufac turers, prior to marke ting a medical device , to obtain either Premarke t Approva l (PMA) or Premarke t Notification. T h e l atter is soug ht under Section 510(k) - 11 -No. 11-3726

Krumpelbeck

v. Breg

o f t h e Fe d er al Food, Drug , and Cosmetic Act, see 21 U.S.C. § 360(k), and is a signific antly less rig orous option than PMA. I t is available wher e the manufa cture r seeks approva l fo r a m ed i cal device that is substantially equivalent to another leg ally marke ted, FDA -appr oved d ev i ce . A limit ation of S ec t i o n 5 1 0 (k) clea ranc e is that the FDA will only approve a new device for the particula r indications and uses for which the predic ate device has been previously approve d. Continuous-infusion pain pumps have been utiliz ed in medical prac tice since the 1960s, b u t t h e evidenc e indicate s that they have ne ver be en F DA-a

pproved f or orthopedic or intra- articula r use. On four occa sions betwee n 1998 and 2004, Br eg applied for Section 510(k) approva l for various pain-pump models and included in its applications ref erence s to intra-a

rticular and orthopedic use. On eac h occa sion, the FDA denied Br eg ’s applications beca use of the ref

ere nces to intra-a rticular and/or orthopedic use, indications which had never befor e been approve d for any of the predic ate device s Br eg cited in support of its applications. The FDA would not clea r the device for these uses beca

use Br eg prese nted “no acc ompany ing data to demonstrate that [t he] device may be used safe ly and eff

ectively [for such] use.” Br eg ’s applications for FDA clea ranc e wer e approve d only afte r all ref

ere nces to intra-a

rticular/or thopedic use wer e deleted, and the pumps wer e subsequently

clea red f or g ener al surg ical use. Contrary to Krumpelbe ck’s assertions, th e FDA’s rejec tion of Breg ’s § 501(k) application

was not ba sed on any known risks of intra-a rticular use of pain pumps but rathe r on the absence of any studies or data aff

irmatively establishing the safe ty of such use. There fore , the FDA ’s reje ction
cannot g ive rise to a finding that Br eg knew, or should have known, that its device was unsafe when

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Krumpelbeck

v. Breg used in the joint space beca use the FDA ’s decision was not based on any finding that the pump was actua lly unsafe when so used. Howeve r, whether the FDA ’s reje ction did or should have put Br eg on notice of the need to conduct testing of its pumps to establish their safe ty for orthopedic and intra-a rticular use is another question entirely

. Had Br eg elec ted to promote and marke t its pain pump only for those uses clea red by the FDA , perha

ps Br eg would have no duty to conduct such testing. But there is evidenc e in the

rec ord from which a jury could conclude t h at Br eg actively marke ted its products for off- label orthopedic a

nd/or intra-a

rticular use without conducting any rele vant safe ty

studies. For instance, Plaintiff’s Ex hibit 57, submitt ed in support of Krumpelbe ck’s opposition to the motion for summ ary judgmen t , is a New P roduct Release for Br eg ’s P ain C are 4200 pump, dated Se p t ember 2002. This is an internal document, appar ently direc ted to Br eg ’s sales forc e, which descr i b es t h e various components, fea tures, benef

its, and specific ations of the 4200 pain pump. Under the hea ding “ I ndications,” the doc ument rea ds: Desig ned for local wound site infusion of non-nar cotic medication s fo r p ostopera tive pain manag ement: - Arthr oscopic proc edure s

- Open Orthope dic proce dures

- Combination Art hroscopic and Ope n orthopedic proce dures - I liac Crest bone g raf

t harve st sites - Ge nera l surg ery - Plastic surg ery (empha sis added)

. The indications clea rly list orthopedic proce dures, a use that the FDA expressly informed Br eg it would not approve due to Br eg ’s lack of data supporting the safe ty of such use. A jury could conclude that a rea sonable manufa cture r would not marke t a product for a particula r off- - 13 -No. 11-3726

Krumpelbeck

v. Breg label use without f

irst c onducting tests to establish the safe ty of such use . There is also Plaintiff’ s Ex hibit 54, another of Br eg ’s internal documents submitt ed in support of Krumpelbe ck’s opposition
to Br eg ’s motion. The rele vant portion of this document d es cr i b es p lace ment of the pain pump cathe ter and indi ca t es that it should be place d at the orig in of the pain, including around the joint and/or direc tly into the joint cavity

. (Seale d App. at 140.) This is further evidenc e from which a jury could find that Br eg actively promoted the use of its pain pumps for off- label use direc tly in the joint space . Finally , Krumpelbe ck’s surg eon, Dr. Paul Favorito testified that “B REG did promote the use of intra-a rticular pain cathe ters. They never promoted them that I reme mber direc tly in the shoulder, but I know they

promoted them in the knee .” Whil e promoting an off- label use does not nece ssarily g ive rise to liability in itself, promoting a use for which the safe ty and long- term eff ect s h av e n ever been tested or established might give rise to liability

. L i k e t h e s u ff i cienc y of t he medical literature , it is for a jury to decide wh et h er a rea sonable manufactur er in Br eg ’s pos ition would have conducted such testing prior t o promoting a

n off- label use of

its product. 2. Claim s prem ised on a mat erial m isrepre sentation This same evidenc e of off- label marke ting and pro m o t i on is rele vant to Krumpelbe ck’s claims that are based on a materia l misrepre sentation, which are : strict liability for nonconfor mance with repr esenta tions; brea ch of express war ranty ; brea ch of implied war ranty ; neg lige nt misrepre sentation and fra u d

. T h e b as es of all of these claims is that Br eg made repr esenta tions reg arding the safe ty

and quality

of the pa in pump and that the pain pump did not confor m to these repr esenta tions because it was not safe for a ll uses for which B reg marke ted it. - 14 -No. 11-3726

Krumpelbeck

v. Breg Be cause they wer e abrog ated by the 2005 amendment to the OPL A, as discussed supra , the district court proper ly g rante d summary judgme nt on Krumpelbe ck’s common law claims of brea ch of express war

ranty , brea ch of implied war ranty , and neg lige nt misrepre sentation an d fra ud. Howeve r, the essenc e of these claims is action ab l e u n der § 2307.77 of the OPL A, which encompa sses all product liability claims based on nonconfor mance with a manufa cture rs’ repr esenta tions. This provisi on provides that “[a] product is def ective if it did not conform, when it left the control of its manufa cture r, to a repr esenta tion made by that manuf

ac turer.” Ohio Rev. Code § 2307.77. The product may be defe ctive even if the “manuf actur er did not a ct fra

udulently ,

rec klessly , or neg lige ntly in making the repr esenta tion.” Id. To preva il on this claim, a plaintiff
must prove that: 1) the defe ndant made a repr esenta tion as to a materia l fac t reg arding the char acte r or qualit y of i ts product; 2) the produc t failed to confor m to the defendant’s repre sentation; 3) t he plaintiff justifiably relied on the defe ndant’s repr esenta t i o n; and 4) such relianc e direc tly and proxi mately cause d the plaintiff’s alleg ed injuries. Miller v. ALZA Corp. , 759 F. Supp. 2d 929, 942 (S.D. Ohio 2010) (c itations omi tted). As noted above, there is evidenc e in the rec ord from which a jury could conclude that Br eg actively promoted its device for use direc tly in the joint spac e. What the rec ord lacks, howeve r, is evidenc e that Br eg ’s repr esenta tives made any express repr esenta tions to Krumpelbe ck—either direc tly or throug h Dr. Favorito—reg arding the safe ty , eff icac y , or FDA approva l of such use. Krumpelbe ck’s complaint aver s g ener ally that Br eg “made repr esenta tions re g arding the char acte r

or quality of the Br eg Pain Pump, including repr esenta tions that the Br eg Pain Pump was safe ” and that the device did not confor m to these repr esenta tions. Krumpelbe ck also asser ted in her response - 15 -No. 11-3726

Krumpelbeck

v. Breg to the motion for summary judgme nt that “B reg and the other manufa cture rs . . . falsely repr esent[ed] to phy sicians that the F DA had a pproved the pumps f

or joint space use.” Howeve r, Krumpe lbeck has failed to identify wher e, to whom, or by whom these alleg ed repr esenta tions wer e made, nor has she pointed to any

evidenc e to substantiate her alleg ations. The only evidenc e in the rec ord that would appea r to spea k t o t h i s i s sue is Dr. Favorito’s deposition testimony

. Dr. Fa vorito indicated that Br eg did not war n him that intra-a

rticular use was not clea red by the FDA and that, at t he t i m e he was using Bre g ’s device i n that manner , he did so with the belief that the device had been clea red by the FDA for such use. Howeve r, Dr. Favorito did
not testify that a repr esenta tive of Br eg aff irmatively told him that the pump had been FDA -appr oved for orthopedic and/or intra-a rticular use. Absent some evidenc e showing that Br eg made an express repr esenta tion to Krumpelbe ck and/or her doctor reg arding the safe ty or FDA approva l of its pump for use in the joint space, summary judgme nt on this claim was appropr iate. 6 IV. CONCLUSION For the fore g oing r easons, we AF F IRM the district court’s g rant of summar y judgme nt as to Krumpelbe ck’s claims of nonconfor mance with repr esenta tions, neg lige nce, brea ch of express

war ranty , brea ch of implied wa rra nty , neg lige nt misrepre sentation and fra ud. We REVERSE and REMAND for further procee dings as to Krumpelbe ck’s statutory claims for defec tive d esig n and inadequa te war

ning or instruction.

Aside from Krumpelbe ck’s failure to show that Br eg made an express repr es en t at ion 6 reg arding a materia l fac t, we note that the rec ord is also lacking in evidenc e of other elements of this claim—namely , justifiable relianc e and c ausation. - 16 -