Kelley et al v. UNICO Holdings, Inc. et al

Filing 33

REPORT AND RECOMMENDATIONS re 28 MOTION to Strike Exhibits A, C, D & E attached to Plaintiffs' Brief in Opposition to Defendants' Motion for Summary Judgment filed by UNICO Holdings, Inc., CVS Pharmacy, Inc., 21 MOTION for Partia l Summary Judgment as to Applicability of Ohio Damage Caps filed by UNICO Holdings, Inc., CVS Pharmacy, Inc., 19 MOTION for Summary Judgment filed by UNICO Holdings, Inc., CVS Pharmacy, Inc.: that defendants' motion for summary judgment (Doc. 19) be GRANTED and this case be CLOSED; defendants' motion for partial summary judgment (Doc. 21) be DENIED AS MOOT; and the motion to strike (Doc. 28) be DENIED AS MOOT. Objections to R&R due by 8/3/2009. Signed by Magistrate Judge Timothy S. Black on 7/16/09. (jl1, )

U N I T E D STATES DISTRICT COURT S O U T H E R N DISTRICT OF OHIO W E S T E R N DIVISION

J A C K KELLEY, et al, P l a i n t if f s , vs. U N IC O HOLDINGS, INC., et al., D e f e n d a n ts .

: : : : : : : : :

C a s e No. 1:07-cv-8 W e b e r , J. B la c k , M.J.

R E P O R T AND RECOMMENDATION 1 THAT: DEFENDANTS' MOTION FOR S U M M A R Y JUDGMENT (Doc. 19) BE GRANTED AND THIS CASE BE C L O S E D ; DEFENDANTS' MOTION FOR PARTIAL SUMMARY JUDGMENT (D o c . 21) BE DENIED AS MOOT; AND DEFENDANTS' MOTION TO STRIKE (D o c . 28) BE DENIED AS MOOT T h is civil action is now before the Court on: (1) the motion for summary judgment f ile d by Defendants, Unico Holdings, Inc. and CVS Pharmacy, Inc. (Doc. 19) and the p a rtie s' responsive memoranda (Docs. 25, 29); (2) Defendants' motion for partial s u m m a ry judgment (Doc. 21) and the parties' responsive memoranda (Docs. 24, 30); and (3) Defendants' motion to strike (Doc. 28). I . BACKGROUND AND FACTS In March 2005, Plaintiff, Jack Kelley ("Kelley"), was scheduled to undergo a r o u tin e screening colonoscopy with Dr. Kim Jurell, a Board certified gastroenterologist

Attached hereto is a NOTICE to the parties regarding objections to this Report and Recommendation.

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w ith Greater Cincinnati Gastroenterology Associates. (Kelley Deposition, p. 31). Before th e procedure, Kelley was instructed by Dr. Jurell to separately consume two 1.5 fluid o u n c e (45 ml) bottles of Fleets Phospho-soda (an "oral saline laxative") within a 12 hour tim e period. (Kelley Deposition, p. 33, 38, 43). On or about March 9, 2005, while out of town on business, Kelley allegedly p u rc h a s e d an oral saline laxative ("the CVS laxative") from a Nashville, Tennessee CVS s to re in preparation for his scheduled colonoscopy on March 11, 2005. (Kelley D e p o sitio n , pp. 45-47). The CVS laxative is manufactured, packaged and distributed by D e f e n d a n t, Unico Holdings, Inc. (Affidavit of Edward Finnegan, attached as Exhibit B to D e f en d a n ts ' motion for summary judgment). At the Nashville CVS store, Kelley c o m p a r e d the CVS laxative to the "national brand" Fleet Phospho-soda and, noting that th e active ingredients were the same, purchased the CVS laxative as a lower cost a lte rn a tiv e . (Kelley Deposition, p. 47). Initially, Kelley testified at deposition in this case that he purchased two separate 1 .5 ounce packages of the CVS product from the Nashville CVS store. After learning that Defendants only manufactured and sold 3 ounce packages at the time of Kelley's a lle g e d purchase, and that the Nashville CVS store sold only one 3 ounce package of the C V S laxative during the week of Kelley's alleged purchase, Kelley now remembers p u rc h a s in g only a single 3 ounce package of the CVS laxative from the Nashville CVS s to re . (Kelley Affidavit, ¶¶6-7, attached as Exhibit A to Plaintiffs' response in opposition

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to summary judgment; see, also, Exhibits B & C, attached to Defendants' motion for su m m ary judgment). O n March 10, 2005, Kelley traveled back to Cincinnati from Nashville. (Kelley D e p o sitio n , pp. 53-55). Before taking the CVS laxative in preparation for his c o l o n o s c o p y, Kelley read the warning label on the product package, which provides: U ses · a s a laxative, for relief of occasional constipation · a s a purgative, for use as part of a bowel cleansing re g im e n in preparation of surgery, x-ray or endoscopic e x a m i n a tio n Warnings D o s a g e warning: Taking more than the recommended d o se in 24 hours can be harmful. D o not use or stop using this product and consult a doctor if you: · h a v e rectal bleeding · h a v e no bowel movement after use, as dehydration m a y occur A sk a doctor before using this product if: · Y o u have nausea, vomiting, or abdominal pain · Y o u have a kidney disease · Y o u have a sudden change in bowel habits lasting m o re than 2 weeks · Y o u have already used a laxative for more than 1 week (E x h ib it B, attached to Defendants' motion for summary judgment). The product re c o m m e n d e d a dose of "20 to 45mL" for adults and children over 12. (Id.) The package f u rth e r states that 45mL (or 1.5 ounces) is a single daily dose and warns consumers to " N O T take more of this product unless directed by a doctor (see warnings)." (Id.) -3-

T h o u g h Kelley remembered reading the package, he admitted that, to the extent the C V S laxative package contained information conflicting with Dr. Jurell's instructions, he w o u ld defer to Dr. Jurell's instructions. (Kelley Deposition, p. 59). A f te r reading the package and opening the product, Kelley took the first dose of th e product at approximately 4:00 p.m., March 10, 2005. (Kelley Deposition, p. 55). Kelley contends that he consumed only 1.5 ounces for his first dose. Sometime later, e ith e r during the evening of March 10, 2005, or the next morning, March 11, 2005, K e lle y took a second dose of the product. (Kelley Deposition, p. 69). Again, Kelley c o n ten d s that he consumed only 1.5 ounces of the product for his second dose as well. O n March 11, 2005, Kelley underwent his routine colonoscopy. (Kelley D e p o sitio n , p. 69). Immediately following the procedure, Kelley began experiencing s to m a c h soreness, fatigue, weakness, a strange taste in his mouth, and bouts of nausea and v o m itin g . (Kelley Deposition, pp. 82). Kelley contacted both his primary care physician a n d Dr. Jurell. (Kelley Deposition, p. 85). Dr. Jurell told Kelley that there were no c o m p lic a tio n s with the procedure. (Kelley Deposition, p. 82). Kelley was referred to a n e p h ro lo g is t and underwent a kidney biopsy. (Kelley Deposition, p. 87, 102-103). Kelley w a s informed that he may have sustained an acute kidney injury as a result of using the C V S laxative in preparation for his colonoscopy. (Kelley Deposition, p. 102-103).

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I I . PROCEDURAL HISTORY P lain tiff s, Jack and Pamela Kelley (collectively referred to herein as "Plaintiffs"), f iled a complaint against Unico Holdings, Inc. and CVS Pharmacy, Inc. (collectively re f erre d to herein as "Defendants"), in the Common Pleas Court of Butler County, Ohio, o n November 28, 2006. Plaintiffs allege the following causes of action in the complaint: (1 ) product liability - inadequate warning; (2) product liability - defective design and fo rm u lation ; (3) unjust enrichment; (4) fraud and deceit; (5) violations of Ohio's C o n s u m e r Sales Practices Act; and (6) loss of consortium. In their prayer for relief, P la in tif f s , among other relief, requested punitive damages. This action was removed to this Court on the basis of diversity jurisdiction. Following removal to this court, Defendants filed a motion for summary judgment (Doc. 1 9 ) and a separate motion for partial summary judgment (Doc. 21) regarding the a p p lic a b ility of Ohio's damage caps on non-economic damages. Plaintiffs filed responses to both motions (Docs. 24, 25). In support of their response in opposition to Defendants' m o tio n for summary judgment, Plaintiffs included: (A) an affidavit of Kelley; (B) e x c erp ts from Kelley's deposition; (C) an expert report authored by Arthur H. Cohen, M .D .; (D) an expert report authored by Eric Brown, M.D.; (E) an article titled, "Renal F a ilu re Due to Acute Nephrocalcinosis Following Oral Sodium Phosphate Bowel C le a n sin g " ; and (F) excerpts from the deposition of Kim Jurell, M.D. (Attached to Doc. 2 5 ).

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D e f e n d a n ts moved to strike (Doc. 28) the affidavit as Kelley on the grounds that it w a s directly contradictory of his deposition testimony. Defendants also moved to strike E x h ib i ts C, D and E on hearsay grounds. I I I . STANDARD OF REVIEW A motion for summary judgment should be granted if the evidence submitted to th e Court demonstrates that there is no genuine issue as to any material fact, and that the m o v a n t is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(C). See Celotex C o rp . v. Catrett, 477 U.S. 317, 322 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 2 4 2 , 247-48 (1986). The moving party has the burden of showing the absence of genuine d is p u te s over facts which, under the substantive law governing the issue, might affect the o u tc o m e of the action. Celotex, 477 U.S. at 323. All facts and inferences must be c o n s tru e d in a light most favorable to the party opposing the motion. Matsushita Elec. In d u s . Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). A party opposing a motion for summary judgment "may not rest upon the mere a lle g a tio n s or denials of his pleading, but . . . must set forth specific facts showing that th e re is a genuine issue for trial." Anderson, 477 U.S. at 248 (1986). I V . ANALYSIS OF PLAINTIFFS' CLAIMS A . Product Liability 1. A c tu a l Use of the CVS laxative

D e f e n d a n ts argue that Plaintiffs' claims must fail as a matter of law because

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P lain tiff s have not shown actual use of Defendants' product. Defendants point to K e lle y's deposition testimony, wherein he was adamant that he purchased two 1.5 ounce b o ttles of the CVS laxative. Defendants show, however, that at the time of Kelley's a lle g e d purchase of the CVS laxative, they only manufactured and sold 3 ounce bottles of th e CVS laxative, and only began selling 1.5 ounce bottles of the CVS laxative at a later tim e. (Finnegan Affidavit, ¶11, attached as Exhibit B to Defendants' motion for summary ju d g m e n t). Further, the Nashville CVS store where Kelley allegedly purchased the p ro d u c t only sold one 3 ounce bottle during the week of Kelley's alleged purchase, a fact P la in t if f s apparently now concedes. In response to Defendants' contention, Plaintiffs submitted an affidavit of Kelley, w h e re in Kelley states that he was mistaken during his deposition, and that following the d e p o s itio n , he remembered that he only purchased one 3 ounce bottle of the CVS lax a tiv e . (Kelley Affidavit, ¶7). According to Kelley, from time to time before his d e p o sitio n , he shopped at CVS stores and saw 1.5 ounce bottles of the CVS laxative for s a le . (Id., ¶6). Based on those observations, Kelley contends in his affidavit that he " m ista k e n ly believed" that he "purchased two 1.5 ounce bottles" and testified during his d e p o s itio n about his mistaken belief. (Id.) Upon learning that records from the Nashville C V S store reflected "the sale of a single 3 oz. package" of the CVS laxative "for the sales w e e k that included March 9, 2005[,]" Kelley now recalls purchasing only a single 3 o u n c e bottle of the CVS laxative. (Id., ¶7).

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D e f e n d a n ts seek to strike Kelley's affidavit testimony as inconsistent with his p re v io u s deposition testimony. "[A] party cannot create a genuine issue of material fact b y filing an affidavit, after a motion for summary judgment has been made, that e ss e n tia lly contradicts his earlier deposition testimony." Penny v. United Parcel Service, 1 2 8 F.3d 408, 415 (6th Cir. 1997) (citing Reid v. Sears, Roebuck & Co., 790 F.2d 453, 4 6 0 (6th Cir. 1986)). "If a party who has been examined at length on deposition could ra is e an issue of fact simply by submitting an affidavit contradicting his own prior te stim o n y, this would greatly diminish the utility of summary judgment as a procedure for s c re e n in g out sham issues of fact." Reid, 790 F.2d at 460. W ith o u t even considering Kelley's affidavit, issues of fact still remain. While the c o n f lict between Kelley's deposition testimony and CVS's records raise questions as to w h e th e r Kelley actually used the CVS laxative, for purposes of summary judgment, we m u st construe the facts in Plaintiffs' favor. In his deposition, Kelley specifically re m e m b e rs entering a CVS store in Nashville, Tennessee, and purchasing the CVS brand o ra l saline laxative. In total, Kelley recalls purchasing 3 total ounces of the CVS laxative, an d consuming the entire amount. As a result, even without considering Kelley's a f f id a v it, an issue of fact remains regarding Kelley's use of the CVS laxative. 2. I n a d e q u a te warnings

D e f en d a n ts argue that Plaintiff's inadequate warning claim must fail as a matter of law because there is no scientific evidence linking the use of the CVS laxative to acute

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k id n e y impairment and because the CVS laxative label complied with applicable federal re g u la tio n s . Further, Defendants contend that Plaintiffs cannot show proximate causation b e c au s e Kelley would have used the CVS laxative regardless of any additional warnings o n the CVS laxative package. Plaintiffs' response, in essence, asserts that the CVS lax a tiv e warnings failed to adequately warn that use of the CVS laxative could result in a c u te kidney damage. U n d e r Ohio law, inadequate warnings or instructions render a product defective if: (1 ) It is defective due to inadequate warning or instruction at th e time of marketing if, when it left the control of its m a n u f ac tu re r, both of the following applied: (a ) The manufacturer knew or, in the exercise of reasonable c a re , should have known about a risk that is associated with th e product and that allegedly caused harm for which the c la im a n t seeks to recover compensatory damages; (b ) The manufacturer failed to provide the warning or in stru ctio n that a manufacturer exercising reasonable care w o u ld have provided concerning that risk, in light of the lik e lih o o d that the product would cause harm of the type for w h ic h the claimant seeks to recover compensatory damages a n d in light of the likely seriousness of that harm. O h io Rev. Code Ann. 2307.73(A). Failure to warn or instruct "about open and obvious ris k s or a risk that is a matter of common knowledge" does not render a product defective. Ohio Rev. Code Ann. 2307.73(B). i. K n o w le d g e of Risk

D e f en d a n ts contend that they had no knowledge, either actual or constructive,

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re g a rd in g any risk of acute kidney damage associated with the use of oral sodium p h o s p h a te solution. Defendants argue that, in March 2005, there was not sufficient s c ie n tif ic evidence suggesting any association "between using sodium phosphate laxatives a n d acute kidney impairment even when consumed in an off-label, 2 x 45mL [1.5 oz.] d o s in g regimen." In an effort to demonstrate actual or constructive knowledge on Defendants' part, P lain tiff s point to an expert report authored by Arthur Cohen, M.D. Dr. Cohen's d e p o sitio n testimony, rather than his unauthenticated and unsworn expert report, d e m o n stra tes that: p ro b a b ly five years ago, four years ago, a report or two a p p e are d in the literature describing the association of p re p a ra tio n of patients for colonoscopy using oral sodium p h o s p h a te solution and the subsequent appearance of kidney d is e a se with the pathology that we had observed in our m a te ria l, but had not put together with the clinical antecedent f in d in g s or procedures. (C o h e n Deposition, p. 12). Dr. Cohen also testified that he was likely aware of a possible a ss o c iatio n between kidney disease and the use of oral sodium phosphate solution in 2 0 0 4 , following a single-case report he read. (Cohen Deposition, pp. 26-27). H o w e v e r, Dr. Cohen acknowledged that "[a] single case report doesn't carry the weight o f final proof[,]" and that a scientifically accepted association between sodium phosphate s o lu tio n and acute phosphate nephropathy until "sometime after `05 probably during `06 [.]" (Cohen Deposition, pp. 30-31).

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W h ile the possible link between acute phosphate nephropathy and the use of oral s o d iu m phosphate solution was just being discovered around the time Kelley purchased th e CVS product in March 2005, the Court must view this evidence in a light most f a v o ra b le to Plaintiffs. In doing so, genuine issues of material fact remain regarding the iss u e of whether Defendants knew or should have known of the risk of developing acute p h o s p h a te nephropathy following use of the CVS laxative. Such a finding, however, does n o t end the inquiry into Plaintiffs' inadequate warning claim. ii. P r o x im a t e cause

D e f e n d a n ts also contend that there is no evidence suggesting proximate cause. Plaintiffs bear the burden of establishing a defect and establishing that such defect p ro x im a te ly caused the claimed injury. See Ohio Rev Code Ann. 2307.73(A)(2). Plaintiffs "not only must convince the fact finder that the warning provided is u n re a so n a b le, hence inadequate, but he also must establish the existence of proximate c a u se between the [product] and the fact of the plaintiff's injury." Hisrich v. Volvo Cars o f North America, Inc., 226 F.3d 445, 450-451 (6th Cir. 2000) (citing Seley v. G.D. Searle C o ., 67 Ohio St.2d 192, 423 N.E.2d 831, 838 (Ohio 1981). "`In analyzing the proximate c a u se issue as it relates to failure-to-warn cases,' the Ohio Supreme Court `divided p ro x im a te causation . . . into two sub-issues: (1) whether lack of adequate warnings c o n trib u ted to the plaintiff's [use of the product], and (2) whether [use of the product] c o n stitu te [ d ] a proximate cause of the plaintiff's injury." Id.

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W ith regard to the second sub-issue, i.e., whether Kelley's use of the product c a u s e d the alleged injury, there remains a genuine issue of fact. Specifically, Plaintiffs' e x p e rt, Dr. Cohen, testified at deposition that, in his opinion, Kelley's injury was related to his use of the CVS product in preparation for his colonoscopy. (Cohen Deposition, p. 3 2 ). Such evidence creates a genuine issue of fact as to whether use of the CVS product c a u s e d Plaintiffs' alleged injuries. H o w e v e r, Plaintiff must also demonstrate that the failure to warn consumers of p o ss ib le kidney complications associated with the use of the CVS laxative contributed to K e lle y's use of the CVS laxative. Defendants argue that, even in the presence of such w a rn in g , Kelley would have still deferred to his physician's directions and used the CVS la x a tiv e . Plaintiffs provide no counter to such proposition. D e f en d a n ts ' contention is supported by the evidence. Kelley remembers reading th e CVS laxative warnings and directions. (Kelley Deposition, p. 56). Despite the fact th a t the CVS laxative packaging recommended a daily dose of 1.5 ounces, and warned th a t exceeding "the recommended dose in 24 hours can be harmful," 2 Kelley deferred to D r. Jurell's instructions to take twice the daily dose in preparation for the colonoscopy. In essence, Kelley's testimony establishes that, despite anything on the label of the p a c k ag e , Kelley was intent on following Dr. Jurell's instructions "to a T." (Kelley D e p o s itio n , p. 59).

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This exact warning is required by 21 C.F.R. 201.307(b)(2)(i). -12-

P lain tiff s fail to produce evidence showing that a warning regarding possible k idn ey injury would have caused Kelley to refrain from following Dr. Jurell's in s tru c tio n s . As a result, no genuine issue of fact remains concerning the lack causation, an d summary judgment in favor of Defendants is proper on Plaintiffs' failure to warn c la im . 3. D e fe c tiv e Design

" [ A ] product is defective in design or formulation if, at the time it left the control o f its manufacturer, the foreseeable risks associated with its design or formulation . . . e x c ee d e d the benefits associated with that design or formulation." Ohio Rev. Code Ann. 2 3 0 7 .7 5 (A ). Defendants argue that Plaintiffs' defective design claim cannot survive s u m m a ry judgment because Plaintiffs failed to produce any scientific expert testimony s u p p o rtin g a conclusion that the risks associated with the CVS laxative outweighed the b e n e f its associated with the laxative. In support of their argument, Defendants present the expert affidavit of Keith A. F r ie d e n b erg , M.D., who opines that the CVS laxative is a safe and effective product, and th a t the benefits of the product "outweigh the risks particularly with regard to colon c lea n sin g in preparation for colonoscopies." (Friedenberg Affidavit, attached as Exhibit D to Defendants' motion for summary judgment). Specifically, Dr. Friedenberg states th a t: th e re is no better prep in regard to patient tolerability and e f fic a cy. Patient tolerability of colonoscopy preps is one of -13-

th e major barriers to patients undergoing screening c o lo n o s c o p ie s . Screening colonoscopies save lives. Cleansing efficacy leads to more effective and more accurate e n d o s c o p ic exams. (D r. Freidenberg Aff., ¶14). P la in tif f s counter by arguing that the risks associated with the "double-dose" re g im e n recommended by physicians for bowel cleaning before colonoscopies outweigh th e benefits associated with the product. In support of their assertion, Plaintiffs cite two ex h ibits attached to their response in opposition: (1) an unauthenticated and unsworn rep o rt authored by Arthur H. Cohen, M.D., of Cedars-Sinai Medical Center; and (2) a m e d ic a l journal article titled "Renal Failure Due to Acute Nephrocalcinosis Following O ra l Sodium Phosphate Bowel Cleansing." Defendants moved to strike Dr. Cohen's report and the article arguing that both e x h ib its are hearsay and violate Fed.R.Civ.P. 56(E). Plaintiffs filed no response to D e f en d a n ts ' motion to strike. Both of the challenged documents, marked exhibits C and D and attached to Plaintiffs' response in opposition, are unauthenticated and unsworn. Generally, it is improper for courts to rely on unsworn reports in ruling on a m o tio n for summary judgment. See Sigler v. American Honda Motor Co., 532 F.3d 469, 4 7 9 -4 8 0 (6th Cir. 2008) (finding that a court's reliance on unsworn expert reports in su p p o rt of summary judgment is improper under Fed.R.Civ.P 56). However, even if this C o u rt considered both exhibits, the only conclusion that could be extracted from the e x h ib its is that using oral sodium phosphate laxatives for bowel cleansing purposes in -14-

p re p a ra tio n for a colonoscopy presents some risk to patients. Neither exhibit addresses w h e th e r the risk outweighs the benefits associated with the drug. As a result, the only ev iden ce of a risk/benefit conclusion is that provided by Defendants' expert, Dr. F r e id e n b e rg . According to Dr. Freidenburg, the benefits of the drug far outweigh the ri s k s . Further, the article may actually favor Defendants' position, in that it states: "Fleet P h o s p h o - so d a is a widely used and highly effective bowel-cleansing regimen for use b e f o re colonoscopy[,]" and that "irreversible ARF [acute renal failure] due to acute n e p h ro c a lc in o s is is a rare adverse event." As a result, summary judgment in favor of D e f e n d a n ts on Plaintiffs' design defect claim is proper as a matter of law. B . Fraud D e f en d a n ts argue that Plaintiffs' fraud claim cannot withstand summary judgment b e c a u s e there is no evidence of false or misleading representations made by Defendants, a n d that no evidence supports any theory that the product was unsafe when used in the re c o m m e n d e d dose set forth on the product package. Further, Defendants argue that K e lle y did not rely on any representations made by Defendants in either purchasing or u sin g the CVS laxative. In response, Plaintiffs argue that Defendants intentionally m a rk e te d their product as safe and effective for bowel cleansing use before undergoing c o l o n o s c o p i e s. T o prevail on a claim of fraud under Ohio law, a party alleging fraud must prove:

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(a ) a representation or, where there is a duty to disclose, c o n c ea lm e n t of a fact, (b) which is material to the transaction a t hand, (c) made falsely, with knowledge of its falsity, or w ith such utter disregard and recklessness as to whether it is tru e or false that knowledge may be inferred, (d) with the in te n t of misleading another into relying upon it, (e) ju stif iab le reliance upon the representation or concealment, a n d (f) a resulting injury proximately caused by the reliance. Groob v. KeyBank, 108 Ohio St.3d 348, 2006-Ohio-1189, 843 N.E.2d 1170, 1178 (2006) (q u o tin g Gaines v. Preterm-Cleveland Inc., 33 Ohio St.3d 54, 55, 514 N.E.2d 709 (19 8 7 )). W ith regard to any false representation or concealment, Plaintiffs suggest that D e f en d a n ts marketed the product as safe for bowel cleansing before colonoscopies. The C V S laxative label, in fact, lists among its uses: "a purgative for use as part of a bowel c lea n sin g regimen in preparation of surgery, x-ray or endoscopic examination[.]" (Exhibit B , attached to Defendants' motion for summary judgment). However, the product p a c k ag e also warns of harm when exceeding the recommended dose and instructs that c o n s u m e rs not use more than the recommended daily dose unless told to do so by a d o c to r. (Id.) These statements set forth on the product label do not suggest an affirmative re p re se n ta tio n by Defendants that the product is safe and effective for use as a bowel c le a n sin g aid when exceeding the recommended dose. In fact, Unico's current Chief O p e ra tin g Officer testified that, before March 10, 2005:

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U n ic o never marked its oral saline laxative product nor made a n y recommendations to consumers or doctors to exceed the o n -la b e l maximum daily dosage of Oral Saline Laxative for ad u lts (20-45 mL). (F in n e g a n Affidavit, ¶14). Further, there is no evidence that: (1) the CVS laxative is u n s a f e or ineffective when used as a bowel cleanser in the recommended daily dose (C o h e n Deposition, p. 37; Friedenberg Affidavit, ¶11; Wish Affidavit, ¶¶6,8, attached as E x h ib it E to Defendants' motion for summary judgment);3 or (2) that Defendants had any k n o w le d g e of safety issues when used within the recommended dose. E v e n assuming knowingly false representations or material concealments, P lain tiff s have failed to prove reliance on any representation or concealment allegedly m a d e by Defendants. Specifically, Kelley's deposition testimony reveals that Kelley was in te n t on following Dr. Jurell's instructions "to a T," and that Kelley would have d e f au lte d to Dr. Jurell's instructions despite any warning on the product package. (Kelley D ep o sition , p. 59). T h is conclusion is supported by the fact that the CVS laxative packaging re c o m m e n d e d a daily dose of 1.5 ounces and warned that exceeding "the recommended d o s e in 24 hours can be harmful." (Exhibit B, attached to Defendants' motion for s u m m a ry judgment). Despite the instructions and warnings actually written on the p ro d u c t package, Kelley testified that he deferred to Dr. Jurell's instructions and took, at In his deposition, Dr. Cohen testified that he was unaware of any published report or study suggesting a relationship between acute phosphate nephropathy and use of a single 1.5 ounce dose in a 24 hour time period. -173

le a st, twice the daily dose in preparation for his colonoscopy. As a result, there is no e v id e n c e of reliance on any allegedly false representation or concealment of fact. A c c o rd in g ly, Plaintiffs' fraud claim must fail as a matter of law because no g e n u in e issues of material fact remain. Thus, summary judgment in favor of Defendants o n Plaintiffs' fraud claim is granted. C . Ohio Consumer Sales Practices Act ("CSPA") D e f e n d a n ts argue that Plaintiffs' CSPA claim must fail as a matter of law because it is a claim for personal injury. In support of their argument, Defendants cite Ohio Rev. C o d e Ann. 1345.12(C) and Chamberlain v. Am. Tobacco Co., No. 1-96 CV 2005, 1999 U .S . Dist. LEXIS 22636, 1999 WL 33994451 (N.D. Ohio Nov. 19, 1999). Plaintiffs offer n o counter to Defendants' assertion that the CSPA is inapplicable to claims of personal in ju ry. Instead, Plaintiffs reassert their contention that Defendants falsely represented the C V S laxative as safe for bowel cleansing use in preparing for colonoscopies. O h io 's Consumer Sales Practices Act ("CSPA") "prohibits suppliers from c o m m ittin g either unfair or deceptive consumer sales practices or unconscionable acts or p ra c tic e s as catalogued in R.C. 1345.02 and 1345.03." Whitaker v. M.T. Automotive, 111 O h io St.3d 177, 2006-Ohio-5481, 855 N.E.2d 825, 829 (2006) (quoting Johnson v. M ic ro s o ft Corp., 106 Ohio St.3d 278, 2005-Ohio-4985, 834 N.E.2d 791 (2005)). Because th e CSPA is a remedial act, it must be liberally construed to achieve its purpose. Id.; O h io Rev. Code Ann. 1.11.

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P u rsu a n t to Ohio Rev. Code Ann. 1345.12(C), the CSPA does not apply to " [ c ]la im s for personal injury or death." However, "R.C. 1345.12(C) will bar only claims th a t require proof of a personal injury in order to establish a CSPA violation[,]" not c la im s where personal injury is a consequence of the CSPA violation. Whitaker v. M.T. A u to m o tiv e , Inc., 111 Ohio St.3d 1777, 2006-Ohio-5481, 855 N.E.2d 825, 833 (2006). Here, Plaintiffs' alleged personal injuries do not establish the CSPA claims; instead, the a lle g e d personal injuries were a consequence of the alleged CSPA violation, i.e., an alleg ed misrepresentation of fact. Such a conclusion, however, does not end the inquiry o n summary judgment. In support of their CSPA claim, Plaintiffs reassert their position that the CVS p ro d u c t was misrepresented as safe for bowel cleansing use before colonoscopies. As set f o rth above, while the CVS product package describes its use "as a purgative for use as p a rt of a bowel cleansing regimen in preparation of surgery, x-ray or endoscopic e x a m in a tio n [ ,]" it does warn of harm when exceeding the recommended dose. (Exhibit B , attached to Defendants' motion for summary judgment). The product package in s tr u c ts consumers against using more than the recommended daily dose unless in s tru c te d to do so by a doctor. (Id.) Contrary to Plaintiffs' contentions, these statements a re not affirmative representations of the product's safety and effectiveness as a bowel c le a n s e r when exceeding the recommended dose. There is also no evidence that the CVS la x a tiv e is unsafe or ineffective when taken pursuant to the recommended daily dose.

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B e c a u s e the basis of Plaintiffs' CSPA claim, i.e., a misrepresentation of fact, is not su p p o rted by any evidence, no genuine issues of material fact remain. Thus, summary ju d g m en t in favor of Defendants on Plaintiffs' CSPA claim is proper as a matter of law. D . Unjust Enrichment " T o prevail on a claim of unjust enrichment, a party must prove `(1) a benefit c o n f e rre d by a plaintiff upon a defendant, (2) knowledge by the defendant of the benefit, a n d (3) retention of the benefit by the defendant under circumstances where it would be u n ju s t to do so without payment (`unjust enrichment').'" Foley v. American Elec. Power, 4 2 5 F.Supp.2d 863, 877, 875 (S.D. Ohio 2006) (quoting Hambleton v. R.G. Barry Corp., 1 2 Ohio St.3d 179, 465 N.E.2d 1298, 1302 (1984)). In support of their claim of unjust enrichment, Plaintiffs reassert their contention th a t "Defendants intentionally marketed and distributed their product as a safe and e f f e c tiv e bowel cleanser for use prior to a medical procedure." However, as set forth a b o v e , the product label, at best, can be construed as a representation that the product is saf e and effective as a bowel cleanser when used in the recommended dose. Further, P la in tif f s provide no evidence that the product is unsafe or ineffective when used in the r e c o m m e n d e d dose. Absent any evidence of a misrepresentation as alleged by Plaintiffs, it is not unjust for Defendants to retain the benefit conferred upon them by Plaintiffs. Because the basis of Plaintiffs' unjust enrichment claim is not supported by any e v id e n c e, no genuine issues of material fact remain. Thus, summary judgment in favor of D e f e n d a n ts on Plaintiffs' unjust enrichment claim is proper as a matter of law. -20-

E . Loss of Consortium " I n Ohio it is well established that a wife has a cause of action for damages for loss o f consortium against a person who, either intentionally or negligently, injures her h u s b a n d and thereby deprives her of the love, care and companionship of her husband." Perrine v. MPW Indus. Services, Inc., 213 F.Supp.2d 835, 849 (S.D. Ohio 2002) (citing C lo u s to n v. Remlinger Oldsmobile Cadillac, Inc., 22 Ohio St.2d 65, 258 N.E.2d 230, 235 (1 9 7 0 )). Here, absent any meritorious claim by Kelley, his wife's loss of consortium c la im must also fail as a matter of law. As a result, summary judgment in favor of D e f e n d a n ts on Plaintiffs' loss of consortium claim is granted. F. Punitive Damages U n d e r Ohio law, punitive damages are generally allowable "in tort actions which in v o lv e fraud, malice or insult." Preston v. Murty, 32 Ohio St.3d 334, 512 N.E.2d 1174, 1 1 7 5 (1987) (citing Roberts v. Mason, 10 Ohio St. 277 (1859)). "[S]omething more than m e re negligence is always required." Id. "The purpose of punitive damages is not to c o m p e n s a te a plaintiff, but to punish and deter certain conduct." Arbino v. Johnson & J o h n so n , 116 Ohio St.3d 468, 2007-Ohio-6948, 880 N.E.2d 420, 441 (2007) (citing M o s k o v i tz v. Mt. Sinai Med. Ctr., 69 Ohio St.3d 638, 635 N.E.2d 331 (1994)). Actual m a lice is defined as "(1) that state of mind under which a person's conduct is c h a ra c te riz e d by hatred, ill will or a spirit of revenge, or (2) a conscious disregard for the rig h ts and safety of other persons that has a great probability of causing substantial harm."

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P r e sto n , 512 N.E.2d at 1176. Here, Plaintiffs present no argument against Defendants' motion for summary ju d g m e n t on Plaintiffs' prayer for punitive damages. Having found summary judgment p ro p e r in favor of Defendants on Plaintiffs' fraud claim, and finding no evidence s u p p o r tin g a claim of actual malice, summary judgment is proper on Plaintiffs' request f o r punitive damages. V . CONCLUSION A cc o rd in g ly, the undersigned finds that Defendants' motion for summary ju d g m e n t is well-taken. Therefore, based on the foregoing, the undersigned R E C O M M E N D S that: (1 ) Defendants' motion for summary judgment (Doc. 19) be GRANTED; and th is case be CLOSED; (2 ) D e f en d a n ts ' motion for partial summary judgment (Doc. 21) be DENIED a s moot; and (3 ) Defendants' motion to strike (Doc. 28) be DENIED as moot.

D a te : J u ly 16, 2009

s/ Timothy S. Black Timothy S. Black U n ite d States Magistrate Judge

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UNITED STATES DISTRICT COURT S O U T H E R N DISTRICT OF OHIO W E S T E R N DIVISION

J A C K KELLEY, et al, P l a i n t if f s , vs. U N IC O HOLDINGS, INC., et al., D e f e n d a n ts .

: : : : : : : : :

C a s e No. 1:07-cv-8 W e b e r , J. B la c k , M.J.

N O T IC E P u r s u a n t to Fed. R. Civ. P. 72(b), any party may serve and file specific, written o b je c tio n s to this Report and Recommendation within TEN DAYS after being served with a copy thereof. That period may be extended by the Court on timely motion by either side f o r an extension of time. All objections shall specify the portion(s) of the Report and R ec o m m en d atio n objected to and shall be accompanied by a memorandum of law in support o f the objections. A party may respond to an opponent's objections within TEN DAYS after b e in g served with a copy those objections. Failure to make objections in accordance with th is procedure may forfeit rights on appeal. See Thomas v. Arn, 474 U.S. 140 (1985); United S t a te s v. Walters, 638 F.2d 947 (6th Cir. 1981).