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James R. Condo (#005867)

Amanda C. Sheridan (#027360) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren, Suite 1900 

Phoenix, AZ 85004-2204 

Telephone: (602) 382-6000 

jcondo@swlaw.com 

asheridan@swlaw.com 

Richard B. North, Jr. (admitted pro hac vice) 

Georgia Bar No. 545599 

Matthew B. Lerner (admitted pro hac vice) 

Georgia Bar No. 446986 

NELSON MULLINS RILEY & SCARBOROUGH LLP 

Atlantic Station 

201 17th Street, NW, Suite 1700 

Atlanta, GA 30363 

Telephone: (404) 322-6000 

richard.north@nelsonmullins.com 

matthew.lerner@nelsonmullins.com 

Attorneys for Defendants 

C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc.

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: Bard IVC Filters Products Liability 

Litigation, 

No. 2:15-MD-02641-DGC

DEFENDANTS’ REPLY IN 

SUPPORT OF MOTION FOR 

SUMMARY JUDGMENT AS TO 

PLAINTIFF DEBRA MULKEY’S 

CLAIMS 

DEBRA MULKEY, an individual, 

Plaintiff, 

v. 

C. R. BARD, INC., a New Jersey 

corporation and BARD PERIPHERAL 

VASCULAR, INC., an Arizona 

corporation, 

Defendants.

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested) 

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Plaintiff seeks to avoid summary judgment on all of her claims by (a) ignoring 

clear and unequivocal testimony in the record, (b) asking this Court to recognize legal 

duties not previously recognized under Kentucky law, (c) asking this Court to recognize 

causes of action not previously recognized under Kentucky law, and (d) jumping to legal 

conclusions based on facts that do not support Plaintiff’s logical leaps. As explained in 

Bard’s opening brief (Doc. 7334), and as explained in further detail below, Bard is 

entitled to judgment as a matter of law as to all of Plaintiff’s claims.1

A. The 1-Year Kentucky Statute of Limitations Bars Plaintiff’s Claims.

i. Plaintiff Knew of Her “Fact of Injury” on October 4, 2012. 

Plaintiff does not dispute that she subjectively knew on October 4, 2012, that her 

physician could not remove her Eclipse Filter. She does not dispute her knowledge that 

her physician was having “problems” when he tried to remove her filter. (Mulkey Dep. 

Tr., at 99:7-10 (attached as Ex. E to Defs. SSOF).) She does not dispute or attempt to 

explain her testimony that she was “upset” on October 4, 2012, when she learned that her 

filter could not be removed. (Id. at 185:3-9.) And she does not dispute her testimony that 

the first time she experienced symptoms of any “bodily injuries” was on October 4, 2012, 

the day of her unsuccessful removal surgery. (Id. at 142:8-24).) Nonetheless, Plaintiff 

claims that the discovery rule should toll the running of the statute of limitations until 

October 2015, when she “saw a commercial on TV that indicated that IVC filters were 

causing bodily injuries to people.” (PFS at § II.13(c) (attached as Ex. A to Defs.’ SSOF).) 

Plaintiff’s arguments are incorrect. A plaintiff merely needs to know (or reasonably 

1

 As part of her response papers, Plaintiff filed a 17-page “Controverting Statement of 

Facts” (Doc. 7946), and she relies on a 52-page “Omnibus Separate Statement of Facts” 

(Doc. 7950). The District of Arizona Local Rule 56.1(b) does not require a moving party 

to reply to a “controverting statement of facts” or respond to a non-moving party’s 

“additional facts.” Accordingly, Bard is not filing such a reply or response here. As noted 

throughout this Reply Brief, however, these allegations do not raise a genuine issue of 

material fact that would preclude summary judgment. Instead, Plaintiff’s reference to 

these allegations appears to be largely an attempt to “pack” the summary judgment record 

with irrelevant allegations (e.g., allegations about filters that Plaintiff did not receive). To 

be clear, Bard disagrees with Plaintiff’s characterization of many of these alleged “facts,” 

even if such disagreement does not raise a genuine issue of material fact. 

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should know with the exercise of reasonable diligence) of the “fact of injury” for the 

statute to start running. Fluke Corp. v. LeMaster, 306 S.W.3d 55, 60 (Ky. 2010); see also

Bridgefield Cas. Ins. Co. v. Yamaha Motor Mfg. Corp. of Am., 385 S.W.3d 430, 433 (Ky. 

Ct. App. 2012) (same); Bosch v. Bayer Healthcare Pharm., Inc., 13 F. Supp. 3d 730, 737 

(W.D. Ky. 2014) (same). 

Plaintiff argues that the discovery rule should apply because she did not know she 

was “wronged” until October 2015, (see Pl.’s Resp. at 4), which is the time when she saw 

a TV advertisement soliciting potential IVC filter plaintiffs. Contrary to Plaintiff’s 

argument, her injury—that is, the fact that her IVC filter could not be removed—is not the 

type of “inherently unknowable” injury that may trigger the discovery rule. See Davis v. 

All Care Med., Inc., 986 S.W.2d 902, 906 (Ky. 1999) (noting that the discovery rule 

applies in cases that “center around injuries of an inherently unknowable nature”). 

Plaintiff relies heavily on Wiseman v. Alliant Hospitals, Inc., 37 S.W.3d 709 (Ky. 

2000) in arguing that the discovery rule should apply. Wiseman, and other “foreign 

object” or “latent injury” cases are readily distinguishable from this case.2 In Wiseman, 

the plaintiff did not know that her doctor left a foreign object (a piece of a metal medical 

instrument) in her body until almost seven years after her procedure. See id. at 711. Thus, 

the plaintiff’s knowledge base in 1989 (when she had her procedure) was fundamentally 

different than her knowledge base in 1996 (when she learned for the first time that a 

foreign object was left in her body). Here, no such fundamental change in Plaintiff’s 

knowledge base occurred between October 4, 2012 (the date of her unsuccessful removal 

2

 Plaintiff argues that she sustained a “latent injury.” (Pl.’s Resp. at 6.) She is mistaken. 

The Sixth Circuit in Asher v. Unarco Material Handling, Inc., 596 F.3d 313 (6th Cir. 

2010), applying Kentucky law, explained the difference between latent injury and nonlatent injury cases. In the former, a plaintiff’s injuries or symptoms do not manifest until 

years after exposure to a product. See id. at 321 (citing the asbestos/mesothelioma case of 

Louisville Tr. Co. v. Johns-Manville Prod. Corp., 580 S.W.2d 497 (Ky. 1979) as an 

example of a latent injury case). In contrast, a non-latent injury case is when a plaintiff’s 

injuries or symptoms “manifest[] immediately.” Asher, 596 F.3d at 321. Here, Plaintiff 

admits that she first experienced “symptoms” of her “bodily injuries” on October 4, 2012, 

the day of her removal procedure. (Mulkey Dep. Tr., at 142:8-24 (attached as Ex. E to 

Defs.’ SSOF).) 

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surgery) and October 2015 (the date when she saw the advertisement). At both points in 

time, Plaintiff knew that her Eclipse Filter could not be removed. The only difference is 

that in October 2015, Plaintiff saw a law firm advertisement that told potential IVC filter 

plaintiffs to call a toll-free number, which Plaintiff did. Plaintiff fails to point to any other 

evidence—such as a doctor’s advice, a publicly issued notice regarding IVC filters, etc.—

that she claims trigged her discovery of her “injury.” Plaintiff also fails to cite any 

authority for her novel legal position applying the discovery rule when, as in this case, the 

plaintiff knew of the facts of the alleged injury, but did not subjectively believe she was 

wronged until seeing a TV advertisement soliciting potential plaintiffs. 

Plaintiff’s argument is, in essence, that the discovery rule should toll the running of 

the statute of limitations until she subjectively knew she may have a claim against Bard 

(i.e., in October 2015 after seeing the TV advertisement). She attempts to rely on 

Kentucky’s distinction between discovery of an “injury” versus “harm,” (see Pl.’s Resp. at 

2), and then focuses on her subjective knowledge of her alleged injury. (See, e.g., Pl.’s 

Resp. at 3 (“Ms. Mulkey did not believe there was anything defective about her filter.”; id.

at 4 (“Ms. Mulkey did not believe she had been wronged by the manufacturer of the IVC 

filter, Bard.”).) Plaintiff’s emphasis on her subjective knowledge is misplaced. In 

Kentucky, “[t]he discovery rule focuses not on when a plaintiff has actual knowledge of a 

legal cause of action, but whether a plaintiff acquired knowledge of existing facts 

sufficient to put the party on inquiry.” Blanton v. Cooper Indus., Inc., 99 F. Supp. 2d 797, 

802 (E.D. Ky. 2000). Thus, contrary to Plaintiff’s suggestion, “[t]he date that a party 

‘discovers’ that he or she may sue for a wrong is not considered.” Id. at 801. 

The Kentucky Court of Appeals recently addressed, and rejected, a similar 

argument to the one advanced by Plaintiff here. In Wells v. Trover, No. 2012-CA-001885-

MR, 2016 WL 99824 (Ky. Ct. App. Jan. 8, 2016), the court held that a plaintiff’s claim 

accrued on the date that a radiologist misread the plaintiff’s x-ray revealing a broken 

bone, not years later when the plaintiff first learned of a putative medical malpractice 

class action against the physician. See id. at *2-3. The plaintiff argued that although she 

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knew she had been harmed in 2001, “she did not know she had been injured or wronged 

(i.e., that someone had invaded her legally protected interests) until March 2004 when the 

article in the Madisonville Messenger was released informing the public of Dr. Trover and 

the Foundation’s alleged negligence.” Id. at *2. Thus, according to the plaintiff in Wells, 

her filing of her lawsuit against the physician in 2005 was timely. See id. Rejecting this 

argument, the Kentucky Court of Appeals stated, “[t]he error in her reasoning is not 

uncommon, but the fact remains that legal confirmation that one has been wronged is not 

necessary under the discovery rule.” Id. at *3 (emphasis in original). “The rule merely 

requires that one be aware of the facts sufficient to put her on notice that her legal rights 

may have been invaded and by whom; uncertainty about the legal significance of those 

facts does not toll the limitations period.” Id. (emphasis in original). 

Plaintiff’s argument seeking to expand the discovery rule also disregards the fact 

that Kentucky’s application of the discovery rule is narrow. See, e.g., Asher v. Unarco 

Material Handling, Inc., 596 F.3d 313, 322 (6th Cir. 2010) (“Kentucky’s courts have 

cautioned against judicial efforts to expand the discovery rule without legislative 

authorization.”). Almost 50 years ago, the Kentucky Supreme Court explained the policy 

rationale behind adopting the discovery rule: “Courts have felt that the injured party 

should be allowed to have his day in court when his injury was of an inherently 

unknowable nature.” Louisville Tr. Co. v. Johns-Manville Prod. Corp., 580 S.W.2d 497, 

501 (Ky. 1979) (emphasis added). The court also explained the rationale for applying the 

discovery rule when the “causal relationship” between the defendant’s product and the 

plaintiff’s injury “do not occur simultaneously.” Id. However, mere erroneous 

assumptions or mistaken beliefs about the cause of a plaintiff’s injury are not sufficient to 

trigger the discovery rule. Asher, 596 F.3d at 322 (affirming district court’s grant of 

summary judgment on a statute of limitations defense, where the plaintiffs were exposed 

to carbon monoxide and immediately manifested symptoms, but believed that the 

symptoms were caused by influenza). 

At bottom, the discovery rule should not be used as a tool for a plaintiff to 

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indefinitely toll the statute of limitations until the date she sees a TV advertisement 

soliciting potential plaintiffs. Extending the discovery in such a manner would contravene 

the policies undergirding the discovery rule, and would be inconsistent with Kentucky’s 

narrow application of the rule. Because Plaintiff knew on October 4, 2012, of her “fact of 

injury,” the discovery rule does not apply, and her claims are time-barred.3

ii. Plaintiff Had a Duty to Inquire About Her Device, and She Failed to 

Discharge That Duty. 

Plaintiff also argues that she had no duty to inquire as to the safety of her device. 

(Pl.’s Resp. at 5-7.) To support her argument, Plaintiff relies heavily on Roberts v. Stryker 

Corp., No. CIV.A. 10-116-HRW, 2011 WL 2912697 (E.D. Ky. July 18, 2011). Roberts is 

distinguishable from this case. Roberts was decided on a Rule 12(b)(6) motion to dismiss. 

See id. at *1. Thus, the court did not have a factual record to review, but, instead, accepted 

as true the plaintiff’s factual allegations. The plaintiff in Roberts had a history of shoulder 

problems before he received the defendant-manufacturer’s shoulder pain pump. See id. at 

*3. This fact was critical to the court’s reasoning, and it concluded, based on that fact, that 

the plaintiff “had absolutely no reason to associate [shoulder] problems with the use of a 

pain pump or to suspect that the pain pump was somehow defective.” Id.

Here, in contrast to Roberts, Plaintiff plainly did not have a history of having an 

IVC filter that could not be removed, which is the alleged injury she suffered. Instead, she 

was upset and knew her physician had problems attempting to remove her device. 

Plaintiff’s subjective knowledge on October 4, 2012, that her filter could not be removed 

should have “excite[d] [her] suspicion” such that she effectively had at that time “actual 

3

 In a footnote, Plaintiff suggests that this Court should reject Bard’s statute of limitations 

arguments because this is a bellwether case. (Pl.’s Resp. at 1 n.1.) Plaintiff cites no 

precedent or authority for a court to reject an otherwise meritorious argument that would 

dispose of a case merely because it is a bellwether case. Moreover, Plaintiff’s argument is 

based on a false assumption: That her case, with a meritorious statute of limitations 

defense, is not representative of a significant portion of the 323 cases in the Discovery 

Group Pool 1. To the contrary, Bard has conducted a preliminary statute of limitations 

assessment of the 323 cases in Pool 1 and has determined that approximately 84 of the 

cases—or 26% of the 323—have potential statute of limitations defenses. Accordingly, 

Plaintiff’s case, and Bard’s meritorious statute of limitations defense, is representative of a 

significant percentage of the Pool 1 cases. 

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knowledge of [her] entire claim.” LeMaster, 306 S.W.3d at 64. Consistent with Kentucky 

law, on October 4, 2012, Plaintiff had a duty to “inquire into the safety of [her Filter]” to 

determine whether the “product may have been a potential cause of an injury.” Id.

Finally, the record is clear that before October 2015, Plaintiff took no action to 

attempt to discover whether she had been injured. But before the Kentucky discovery rule 

can even be applied, a plaintiff must first exercise “reasonable diligence” to discover her 

injury, which means investigation that “must be more than merely perfunctory.” Blanton, 

99 F. Supp. 2d at 802 (internal citations and quotation marks omitted); Manning v. Arch 

Wood Prot., Inc., No. CV 13-127-HRW-CJS, 2016 WL 7910818, at *4 (E.D. Ky. Aug. 

30, 2016) (same). “Plaintiffs may not close their eyes to means of information reasonably 

accessible to them and must in good faith apply their attention to those particulars which 

may be inferred to be within their reach.” Blanton, 99 F. Supp. 2d at 802. “[P]otential 

plaintiffs cannot simply wait for someone else to connect the dots for them.” Manning, 

2016 WL 7910818, at *4. 

Here, Plaintiff failed to exercise reasonable diligence. She waited until October 

2015 for a TV advertisement soliciting potential IVC filter plaintiffs to “connect the dots” 

for her. Her “failure to make any inquiry despite having sufficient information available to 

[her] is deemed a failure to exercise reasonable diligence as a matter of law.” Blanton, 99 

F. Supp. 2d at 803. The discovery rule does not apply to Plaintiff’s claims. Instead, her 

claims are time-barred by Kentucky’s 1-year statute of limitations. 

B. Plaintiff Fails to Identify a Genuine Dispute as to Any Material Fact 

Regarding Her Failure to Warn Claim. 

i. Plaintiff Cannot Prove Causation. 

Plaintiff’s implanting physician, Dr. Tompkins, testified under oath unequivocally 

that he does not rely on information from a medical device manufacturer in deciding 

which IVC filter to use. His precise testimony, which was elicited by Plaintiff’s counsel 

on direct examination, is as follows: 

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19 Q So -- so in -- in deciding which -- 

20 which filter to use, do you rely on information

21 from the manufacturer?

22 A No.

(Tompkins Dep. Tr., at 88:19-22 (attached as Ex. C to Defs.’ SSOF) (emphasis added).) 

Dr. Tompkins also testified that he would be speculating as to whether the alleged factual 

information presented to him by Plaintiff’s counsel would have altered his treatment 

decision for Plaintiff. (See Tompkins Dep. Tr., at 184:13 to 185:16 (attached as Ex. C to 

Defs.’ SSOF (“Q Okay. So -- so again, being shown a draft e-mail and asked if you had 

known, if you had known, would you have made a different decision, you’re really 

speculating, aren’t you? MR. DeGREEFF: Object to the form. A Yes.” (emphasis 

added)).) 

Plaintiff’s Response Brief ignores Dr. Tompkins’s testimony above. Instead of 

addressing that testimony, Plaintiff offers six bullet points of other testimony of Dr. 

Tompkins that she alleges demonstrates proximate causation. (See Pls. Resp. at 12-13.) A 

close inspection of that testimony, however, reveals that it does not establish causation for 

two reasons. 

First, many of Plaintiff’s bullet points do not relate to the issue of causation. For 

instance, Plaintiff states “[t]here were risks and problems with Bard’s filters that Bard did 

not tell Dr. Tompkins about.” (Pls. Resp. at 12.) This assertion relates to whether Bard’s 

warnings were legally adequate—and they were, as demonstrated at Section A.ii., infra—

not causation. Plaintiff’s bullet point numbers one and five suffer from this same logical 

flaw. 

Second, the three bullet points that Plaintiff lists that do relate to causation do not 

establish that an alleged inadequate warning was the proximate cause of Plaintiff’s 

injuries (i.e., that a proper warning would have changed Dr. Tompkins’s treatment 

decision). The first bullet point is that “[i]f Dr. Tompkins had expected these issues [tilt, 

perforation, and irretrievability] to occur, he would not have used the filter.” (Pls. Resp. at 

12.) But Dr. Tompkins did not testify that he, in fact, expected those issues to occur after 

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seeing the documents shown to him by Plaintiff’s counsel. Instead, he recognized that 

“[u]nfortunately, there’s complications with any product.” (Tompkins Dep. Tr., at 99:10-

11 (attached as Ex. M-C to Pls.’ OSOF).) Moreover, Plaintiff fails to cite anything in the 

record that Bard’s Eclipse Filter is expected to tilt, perforate, or be unable to be retrieved. 

Thus, Plaintiff has failed to link Dr. Tompkins’s testimony relating to causation (i.e., that 

he would have used another device if he “expected” complications to occur with Plaintiff) 

with the underlying factual predicate (i.e., that it was expected that the filter would cause 

complications with Plaintiff). 

The second bullet point is that “[i]f the Eclipse had a significantly increased risk of 

migration over other filters . . . [Dr. Tompkins] wouldn’t use the filter.” (Pls. Resp. at 13.) 

Again, Plaintiff fails to present evidence of the underlying factual predicate, that is, that 

the Eclipse allegedly has a significant increased risk of migration over other filters. While 

Plaintiff cites evidence of other Bard IVC filters (e.g., Recovery) allegedly having higher 

migration rates compared to other filters, she does not cite the same kind of evidence for 

the Eclipse.4 Additionally, Dr. Tompkins never quantifies what a “significant increased 

risk” means to him. 

The third bullet point that Plaintiff offers is that “Dr. Tompkins would not have 

implanted the Eclipse filters had he been informed that there were deaths occurring 

concurrently.” (Pls. Resp. at 13.) Like the other two bullet points above, this argument 

assumes a factual predicate—that, at the time he implanted an Eclipse Filter in Plaintiff, 

there were “deaths occurring concurrently” with Eclipse—that is not in the record. 

Nowhere in Plaintiff’s Response Brief or in Plaintiffs’ 52-page omnibus statement of facts 

does Plaintiff cite to record evidence demonstrating that deaths were occurring with the 

Eclipse Filter in or around April 2012, when Plaintiff received her device. 

4

 At most, Plaintiff references evidence relating to the comparative fracture rate of 

Eclipse compared to the SNF. (See Pls.’ OSOF at ¶ 114.) But Dr. Tompkins’s testimony 

concerning whether he would use a different device is only in the context of migration, 

not fracture. (See Tompkins Dep. Tr., at 108:10 to 109:1 (attached as Ex. M-C to Pls.’ 

OSOF).) 

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Finally, Plaintiff cites the Tenth Circuit Court of Appeals decision in Tingey v. 

Radionics, 193 Fed. App’x 747 (10th Cir. 2006) for the proposition that, in deciding 

causation, the relevant inquiry is “[c]ould an adequate warning have prevented Ms. 

Mulkey’s injury.” (Pls. Resp. at 12.) Plaintiff’s reliance on Tingey is misplaced for two 

reasons. First, the Tenth Circuit in that case applied Utah law, not Kentucky law. See 

generally Tingey, 193 Fed. App’x 747. Second, the standard for the burden of proof for 

Plaintiff to prove causation in Kentucky is the preponderance of the evidence, i.e., more 

likely than not. As one court has said, causation “must be established by a preponderance 

of the evidence—‘the evidence must be sufficient to tilt the balance from possibility to 

probability.’” Paducah & Louisville Ry., Inc. v. Quixx Corp., No. CIV.A. 4:04CV00176, 

2007 WL 2746673, at *2 (W.D. Ky. Sept. 18, 2007), aff’d, 294 F. App’x 995 (6th Cir. 

2008) (quoting Morales v. Am. Honda Motor Co., 151 F.3d 500, 507 (6th Cir. 1998)). 

Accordingly, whether a different warning could have changed Dr. Tompkins’s treatment 

decision is not the proper inquiry. Instead, the relevant question is whether a different 

warning would have probably changed his decision. Dr. Tompkins testimony cited above 

that he does not rely on information from a manufacturer when deciding which IVC filter 

to use forecloses any such probability. 

ii. Bard’s Warnings Are Legally Adequate.

Bard provided legally adequate warnings to Dr. Tompkins concerning the possible 

risks associated with use of the Eclipse Filter. Plaintiff admits that Bard’s Eclipse IFU 

warns of the risks of filter tilt, migration, fracture, perforation, and inability to retrieve. 

(Pl.’s Resp. at 9.) Arguing that these warnings are legally inadequate, Plaintiff relies on 

Post v. Am. Cleaning Equip. Corp., 437 S.W.2d 516 (Ky. 1969). (See Pl.’s Resp. at 9, 11.) 

The rule from Post is that a manufacturer’s duty to warn is discharged by providing “fair 

and adequate notice of the possible consequences of use or even misuse” of a product. 

Post, 437 S.W.2d at 522 (emphasis added). 

Plaintiff’s various bullet points of alleged facts that Bard did not include in its IFU 

are not “potential consequences” of the use (or even misuse) of the Eclipse Filter. Indeed, 

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of the 16 bullet points that Plaintiff provides, 9 do not relate to the Eclipse Filter at all. 

They instead relate to other products (e.g., the Recovery Filter). The bullet points that do 

relate to the Eclipse Filter do not concern “possible consequences” with the device’s use. 

Five out of the six bullet points that do mention Eclipse relate to the device’s design or 

testing. (See Pl.’s Resp. at 10-11 (bullet points 6, 7, 8, 13, and 155).) The remaining bullet 

point that specifically mentions Eclipse concerns comparative rates, which, as explained 

below, Bard has no legally recognized duty to warn about. (Pl.’s Resp. at 11 (bullet point 

14 (“By June 2011, Bard was aware that the Eclipse, after only a little over a year on the 

market, fractured over 3 1⁄2 times as often as the SNF.”).) Notably, Plaintiff does not 

dispute the fact that Bard warned physicians regarding the possible consequence of filter 

fracture. The final bullet point that Plaintiff provides concerns the theory that caudal 

migration may lead to filter tilt, perforation, irretrievability, or fracture. (See Pl.’s Resp. at 

11 (bullet point 16).) Setting aside the accuracy of this theory,6 the ultimate possible 

consequences of filter use—filter tilt, perforation, irretrievability, or fracture—are all 

potential consequences (i.e., risks) that Bard warned about in the Eclipse IFU. 

iii. No Court Applying Kentucky Law Has Recognized a Legal Duty to 

Warn About Another Product by Providing Comparative Rate 

Information. 

Regarding Plaintiff’s argument that Bard should have provided comparative rate 

information in its warnings, Plaintiff cites no Kentucky precedent (or other authority 

applying Kentucky law) that recognizes a duty to warn about comparative rates. Providing 

comparative rate information necessarily requires providing information about another 

product (i.e., the device to which Bard is comparing the Eclipse). But no Kentucky court 

has recognized a legal duty to warn about another product.7

5

 For example, Plaintiff states “Eclipse is essentially identical to the G2.” (Pl.’s Resp. at 

10 (bullet point 6).) This is an alleged design feature of Eclipse. 

6

 Bard does not agree with Plaintiff’s characterizations and assertions of fact. 

7

 As discussed in greater detail in Bard’s Reply in Support of Its Motion for Summary 

Judgment Regarding Plaintiffs’ Jones, which Bard fully incorporates herein, there is no 

duty to provide comparative warnings, and the Court should decline to impose one here. 

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This is an issue concerning whether a legal duty exists in the first instance, not 

merely whether a warning is adequate.8 “In Kentucky, the existence of a duty is a matter 

of law for the court because [w]hen a court resolves a question of duty it is essentially 

making a policy determination.” Ostendorf v. Clark Equip. Co., 122 S.W.3d 530, 533 (Ky. 

2003) (internal quotation marks omitted; alteration in original); see also Cornett v. 

Labreveux, No. 2016-CA-000614-MR, 2017 WL 3328115, at *2 (Ky. Ct. App. Aug. 4, 

2017) (“The question of whether a duty exists is a matter of law.”). Accordingly, because 

it is an issue of law, this Court, not a jury, should decide whether a medical device 

manufacturer has a legal duty to provide warnings regarding another product. In her 

Response Brief, Plaintiff invites this Court to be the first court in the country to make the 

policy determination that Kentucky should recognize such a duty. Bard respectfully asks 

this Court to decline that invitation. See, e.g., Ackley v. Wyeth Labs., Inc., 919 F.2d 397, 

405 (6th Cir. 1990) (“The manufacturer is obligated to make a reasonable disclosure of all 

the risks inherent in its own drug . . . . It is not obligated to provide a comparison of its 

drug with others.” (applying Ohio law)); Smith ex rel. Smith v. Wyeth Labs., Inc., No. 

CIV.A. 84-2002, 1986 WL 720792, at *9–10 (S.D. W. Va. Aug. 21, 1986) (rejecting 

argument that defendants had a duty to warn of adverse reaction rates as compared to 

competitor products, noting there is “no authority for the proposition that a drug 

manufacturer has a duty to warn prescribing physicians of the rate of adverse reactions” 

and “no authority for [the plaintiffs’] argument that a drug manufacturer may be required 

to represent that other drugs with similar effects are safer,” and “[a]s a practical matter, 

this would extremely difficult, perhaps impossible”). 

C. Plaintiff’s Response Brief Fails to Raise a Genuine Issue of Material 

Fact Concerning Reliance, Which Forecloses Her Misrepresentation 

and Concealment Claims. 

Plaintiff’s Response Brief ignores Dr. Tompkins’s testimony that he does not rely 

8

 In this regard, Bard respectfully suggests that the courts in Cisson and Cason mistakenly 

considered the existence of a legal duty as an issue concerning the adequacy of a warning. 

Thus, their reasoning that Bard’s warnings were inadequate because they did not include 

rate information is flawed. Moreover, neither Cisson nor Cason applied Kentucky law. 

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on information from a medical device manufacturer when deciding which IVC filter to 

use. (See Tompkins Dep. Tr., at 88:19-22 (attached as Ex. C to Defs.’ SSOF).) Instead, 

Plaintiff cites to testimony from Dr. Tompkins that he had seen the Eclipse IFU at some 

point in the past, but that he did not know if he “read every word in it.” (Tompkins Dep. 

Tr., at 105:15-18 (attached as Ex. M-C to Pls.’ OSOF).) Dr. Tompkins also testified that 

his practice is to “look [] over” the IFU for “a new device.” (Id. at 105:19-23.) But the fact 

that Dr. Tompkins may have seen and read portions of the Eclipse IFU does not mean he 

relied on it when he chose which IVC filter to use with Plaintiff. To the contrary, the only 

evidence in the record concerning what Dr. Tompkins relied on is his testimony that he 

relied on his experience, the experience of his colleagues, and the applicable medical 

literature when he decided to implant an Eclipse Filter in Plaintiff. (Tompkins Dep. Tr., at 

202:7-22 (attached as Ex. C to Defs.’ SSOF).) Dr. Tompkins’s review of the Eclipse IFU 

does not create a genuine issue of material fact concerning the element of reliance. 

Plaintiff’s Response Brief also ignores her own testimony that establishes that she 

did not rely on any misrepresentation or concealment by Bard. As noted by Bard in its 

Opening Brief, Plaintiff never received a patient card or brochure regarding her filter, 

never asked for any information about her filter before it was implanted, never spoke to 

anyone at Bard, never visited Bard’s website, and did not even know Bard was her filter’s 

manufacturer until her lawyer advised her long after she received her device. (Defs.’ Br. at 

14 (citing Mulkey Dep. Tr., at 66:23 to 67:1, 67:11-18, 69:24 to 70:1, and 167:11-13 

(attached as Ex. E to Defs.’ SSOF)).) Instead of addressing these facts, Plaintiff argues 

that she indirectly relied on alleged misrepresentations by relying on Dr. Tompkins’s 

professional medical advice. (Pls. Resp. at 14.) 

Kentucky requires direct reliance, not indirect reliance, to support a 

misrepresentation or concealment claim. The Sixth Circuit stated succinctly, “Kentucky 

law requires direct reliance by the plaintiff on the defendant’s statements” to support a 

fraud claim. Goldman Servs. Mech. Contracting, Inc. v. Citizens Bank & Tr. Co. of 

Paducah, 9 F.3d 107, 1993 WL 428641, at *3 (6th Cir. 1993) (table decision) (emphasis 

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added); see also Tunne v. Hendrick, No. 5:10CV-00181-JHM, 2012 WL 3644825, at *4 

(W.D. Ky. Aug. 24, 2012) (“Kentucky law requires direct reliance by a plaintiff on the 

defendants’ statements.”). Reliance on a third party (i.e., Dr. Tompkins), instead of the 

defendant (i.e., Bard), is not sufficient to establish the element of reliance. Again, the 

Sixth Circuit stated, “Kentucky law requires that the party claiming fraud show that he or 

she relied on the alleged misrepresentation, not a third party.” Compressed Gas Corp. v. 

United States Steel Corp., 857 F.2d 346, 352 (6th Cir. 1988) (emphasis added). 

Accordingly, Plaintiff’s indirect reliance argument fails.9

Finally, the majority of Plaintiff’s argument on her misrepresentation and 

concealment claims focuses on the alleged misrepresentations or concealment of facts 

made by Bard. (See Pl.’s Resp. at 13-14.) Bard vehemently disputes Plaintiff’s 

characterization of these alleged misrepresentations or concealments of facts. But Bard’s 

Motion for Summary Judgment argument is based on the lack of reliance by Plaintiff and 

her implanting physician, not the lack of existence of a misrepresentation or concealment 

of fact. 

D. Plaintiff Asks This Court to Create Post-Sale Duties That Have Been 

Previously Rejected by Other Courts. 

The Kentucky Supreme Court in Ostendorf v. Clark Equip. Co., 122 S.W.3d 530 

(Ky. 2003) conclusively rejected an independent post-sale duty to retrofit a product. See 

id. at 537. The Eastern District of Kentucky in Cameron v. DaimlerChrysler Corp., No. 

CIV.A. 504CV24JMH, 2005 WL 2674990 (E.D. Ky. Oct. 20, 2005) similarly rejected a 

post-sale duty to warn. See id. at *7. No court has recognized a post-sale duty to recall in 

Kentucky, but the reasoning of Cameron, which applied Ostendorf, in rejecting a post-sale 

duty to warn applies equally to a post-sale duty to recall. 

Plaintiff asks this Court to ignore the binding precedent of Ostendorf and recognize 

a post-sale duty to retrofit. Plaintiff argues that an independent duty to retrofit exists 

9

 Even if Plaintiff’s indirect reliance on Dr. Tompkins was relevant, as discussed above, 

Dr. Tompkins did not rely on Bard in choosing which filter to use. 

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because “[t]he Bard Eclipse was defective at the time it was sold.” (Pl.’s Resp. at 15.) This 

argument again ignores Ostendorf, when the Kentucky Supreme Court addressed and 

rejected this same argument, stating: “[T]here is a more fundamental reason to eschew 

imposition of a duty to retrofit: that duty is superfluous in light of existing negligence and 

product liability doctrines.” Ostendorf, 122 S.W.3d at 535. “When the case involves a 

retrofit, the plaintiff is claiming the product was defectively designed.” Id. A plaintiff in 

that scenario may bring suit for breach of warranty, negligence, or strict liability in tort. 

Id. Here, Plaintiff already has a remedy if her product is defective10; therefore, according 

to Ostendorf, no separate independent post-sale duty to retrofit exists.11

Finally, Plaintiff claims that the device she received—an Eclipse Filter—is, itself, 

the product of a retrofit program. (Pl.’s Resp. at 16-17.) Plaintiff argues that “Bard 

undertook a voluntary retrofit campaign when it modified the predicate device, the G2X, 

to create the Eclipse Filter.” (Pl.’s Resp. at 16.) Plaintiff goes on to argue that Bard 

negligently undertook this “retrofit campaign.” (Pl.’s Resp. at 16-17.) Plaintiff’s argument 

misses the mark for two reasons. First, Plaintiff fails to cite any authority for her novel 

position that a product that happens to be a second generation (or later) product is, in and 

of itself, somehow a “retrofit campaign” that could subject a manufacturer to liability for 

the negligent undertaking of that campaign in a case involving that same device. Second, 

Plaintiff’s argument ignores the plain meaning of a “retrofit” campaign or program. Under 

Kentucky law, a “retrofit” program contemplates changes or modifications to the actual 

device at issue in the case. Ostendorf removes any doubt about this point. The court noted 

that “[a] duty to retrofit is an example of a post-sale obligation imposed on a 

10 Bard strongly denies that the Eclipse Filter is defective or unreasonably dangerous. 

11 Plaintiff also cites Ostendorf concerning the “analogous” cases cited by the court 

“imposing a duty to warn of later discovered defects.” (Pl.’s Resp. at 15.) Plaintiff fails to 

point out, however, that the Ostendorf court said in a footnote that “[t]he present case does 

not present the issue of a duty to warn. Our discussion addresses that topic only generally, 

as it relates to the issues in this case.” Ostendorf, 122 S.W.3d at 537 n.1. Thus, the court’s 

discussion of other cases identifying a duty to warn of later discovered defects is dicta. 

See Cameron, 2005 WL 2674990 at *7 (“The court’s footnote makes it clear, therefore, 

that any discussion in Ostendorf concerning a post-sale duty to warn is dicta.”). 

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manufacturer.” Ostendorf, 122 S.W.3d at 536 (emphasis added). The court also described 

a duty to retrofit “an existing product.” Id. at 533.12 Accordingly, Kentucky law clearly 

contemplates a claim for negligent undertaking of a retrofit campaign in the context where 

a manufacturer produces a product, and then sometime later attempts to change or modify 

(i.e., retrofit) that same product that is already in the hands of consumers. That is not what 

has occurred in this case. Plaintiff has presented no evidence that Bard “retrofitted” her 

Eclipse Filter after it was implanted in her body in April 2012. Her “negligent 

performance” of a retrofit program fails as a matter of law. 

E. Plaintiff’s Negligence Per Se Claim Fails as a Matter of Law. 

Plaintiff’s Response Brief concedes that her negligence per se claim may not be 

based on alleged violations of federal statutes or regulations.13 Plaintiff claims that her 

negligence per se claim is based on violation of state law, specifically the Kentucky 

Consumer Protection Act (“KCPA”). As demonstrated below, Plaintiff’s KCPA claim 

fails as a matter of law, and, therefore, her negligence per se claim fails as a matter of law. 

F. Plaintiff Fails to Identify a Direct Representation to Her, Foreclosing 

Any KCPA Claim as a Matter of Law. 

Plaintiff admits that privity of contract between the plaintiff and defendant is 

ordinarily required to sustain a KCPA action. (Pl.’s Resp. at 18.) She argues, however, 

that this case falls within an exception to that requirement because Bard made “express 

representations” about her product. (Id.) Plaintiff’s argument fails for three reasons. 

First, to the extent this exception even exists, Plaintiff downplays the requirement 

for the exception to apply. She argues that “express warranties for the benefit of Kentucky 

12 The retrofit program at issue in Ostendorf further illustrates this point. The product at 

issue was a 1980 forklift C-300Y40, and the defendant-manufacturer had undertaken a 

retrofit program to that model of forklift in 1983 following updates to relevant safety 

standards for forklifts. See id. at 532-33. 

13 Plaintiff argues that “Ms. Mulkey’s negligence per se claim is . . . not based on a federal 

statute of [sic] regulation.” But Plaintiffs’ Master Complaint makes clear that the 

negligence per se claim is based on alleged “[v]olations of 21 U.S.C. §§ 321, 331, 352 and 

21 C.F.R. §§ 1.21, 801, 803, 807, 820.” (See Master Complaint for Damages for 

Individual Claims [Dkt. No. 364] at Count IX.) 

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consumers” is sufficient. (Pl.’s Resp. at 18, 19.) Kentucky law requires more for the 

purported exception to the privity requirement to apply. For an express warranty to exist, 

Kentucky law requires “direct representations [to the plaintiff],” and the representations 

must become “a basis of the parties’ bargain.” Naiser v. Unilever U.S., Inc., 975 F. Supp. 

2d 727, 737, 740 (W.D. Ky. 2013). Although the Naiser court’s full quotation is “direct 

representations to consumers,” id., the court’s use of the term “consumers” is because the 

case involved a putative class action. See id. at 731. But the court’s discussion, in the 

context of Kentucky’s requirements for an express warranty under K.R.S. § 355.2-313, 

makes clear that a representation must be made directly from a manufacturer to the 

plaintiff (or plaintiffs) claiming the express warranty. General representations to 

“Kentucky consumers” are not sufficient, when, as here, Plaintiff never saw or heard the 

representations. 

Second, Plaintiff’s attempt to draw a parallel between the facts of this case and the 

facts in Naiser is unavailing. Naiser arose on the defendant’s Rule 12(b)(6) motion to 

dismiss, where the court merely had to assess the sufficiency of the plaintiffs’ pleadings. 

There, the plaintiffs alleged various representations were made directly to them, and that 

they relied on the representations in choosing to purchase the product at issue (a hair 

smoothing kit). Naiser, 975 F. Supp. 2d at 737-38. Here, Plaintiff points to no record 

evidence of any express representation made by Bard directly to her. The list of alleged 

representations at page 19 of Plaintiff’s Response Brief are all generic statements, and 

there is no evidence that Plaintiff ever saw or heard them. As noted above, she never 

received any written information about her filter, never received a patient brochure, never 

spoke to anyone at Bard, and she did not review Bard’s website. (See Defs.’ Br. at 14 

(citing Mulkey Dep. Tr., at 66:23 to 67:1, 67:11-18, 69:24 to 70:1, and 167:11-13 

(attached as Ex. E to Defs.’ SSOF)).) Thus, for example, Plaintiff’s citation to what the 

Eclipse patient brochure stated, (see Pl.’s Resp. at 19), is misplaced and does not support 

her KCPA or express warranty claim. 

Additionally, as argued above at Section C, supra, Plaintiff fails to establish that 

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she relied on any direct representation by Bard concerning her filter. In other words, the 

alleged representations by Bard did not form the “basis of the bargain” between the 

parties. When, as here, a plaintiff does not see or hear a representation from a 

manufacturer about a product, said representation cannot, as a matter of law, form the 

“basis of the bargain” between the parties. See Snawder v. Cohen, 749 F. Supp. 1473, 

1481 (W.D. Ky. 1990) (“Plaintiff’s mother never saw the package inserts before her 

daughter was vaccinated. Thus, any warranty in the package insert was not part of the 

‘basis of the bargain.’”). 

Third, Bard respectfully suggests that no exception to the privity requirement 

should exist under the KCPA, and the Naiser court was mistaken when it read too much 

into dicta in Skilcraft Sheetmetal, Inc. v. Kentucky Mach., Inc., 836 S.W.2d 907 (Ky. Ct. 

App. 1992) and found such an exception. Skilcraft’s holding leaves no room for an 

exception. The court stated, “The language of [the KCPA] plainly contemplates an action 

by a purchaser against his immediate seller.” Id. at 909. The court further explained that 

the Kentucky legislature “intended that privity of contract exist between the parties in a 

suit alleging a violation of the Consumer Protection Act.” Id. In holding that privity is 

required, the Skilcraft court observed that the privity requirement, in conjunction with a 

two-year statute of limitation running from the date of the alleged violation, demonstrates 

the legislature’s “lack of concern for a subsequent purchaser who would often purchase 

used merchandise more than two years after the violation, as indeed was the case here.” 

Id.14 Finally, the Naiser court relied on the Skilcraft court’s discussion of Ford Motor Co. 

v. Mayes, 575 S.W.2d 480 (Ky. Ct. App. 1978). See Naiser, 975 F. Supp. 2d at 743 

(“[Skilcraft] found certain situations ‘distinguishable . . . such as that presented in Ford 

Motor Co. v. Mayes, Ky. App., 575 S.W.2d 480 (1978), where the defendant (Ford Motor 

Company) provides warranties to the ultimate purchaser to repair the item purchased.’” 

14 Bard notes that the alleged representations about the Eclipse Filter identified by 

Plaintiff in her Response Brief that would give rise to a KCPA claim all occurred more 

than two years before Plaintiff filed her lawsuit in 2016. Thus, her KCPA claim is timebarred. See K.R.S. § 367.220. 

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(quoting Skilcraft, 836 S.W.2d at 909)). But in Mayes, the defendant-manufacturer did not 

contest the standing of the consumer-plaintiff to bring a KCPA claim even though the 

consumer purchased the truck from a licensed dealer. See generally Mayes, 575 S.W.2d 

480. Thus, the lack of privity between the plaintiff and defendant was not an issue 

resolved by the Mayes court. 

CONCLUSION 

For these reasons, and for the reasons stated in Bard’s Opening Brief, Bard 

respectfully requests that this Court grant Bard’s Motion for Summary Judgment. 

RESPECTFULLY SUBMITTED this 25th day of October, 2017. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

Georgia Bar No. 545599 

Matthew B. Lerner 

Georgia Bar No. 446986 

NELSON MULLINS RILEY & SCARBOROUGH, LLP 

Atlantic Station 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

PH: (404) 322-6000 

FX: (404) 322-6050 

richard.north@nelsonmullins.com 

matthew.lerner@nelsonmullins.com 

James R. Condo (#005867) 

Amanda Sheridan (#027360) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren 

Phoenix, AZ 85004-2204 

PH: (602) 382-6000 

jcondo@swlaw.com 

asheridan@swlaw.com 

Attorneys for Defendants C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc. 

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CERTIFICATE OF SERVICE 

I hereby certify that on this 25th day of October 2017, the foregoing was 

electronically filed with the Clerk of Court using the CM/ECF system which will 

automatically send email notification of such filing to all attorneys of record. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

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