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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 

PARTIAL SUMMARY JUDGMENT 

OF PLAINTIFF SHERR-UNA 

BOOKER’S CLAIMS 

SHERR-UNA BOOKER, 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 by (a) impermissibly citing numerous 

internal Bard documents and deposition testimony, which have no bearing on Bard’s 

Motion and/or are taken out of context;1 (b) ignoring clear Georgia law; and (c) asking 

this Court to create previously unrecognized duties to warn and a new cause of action 

under Georgia law. For these reasons, and as discussed more fully below and in Bard’s 

Motion, the Court should grant summary judgment on Plaintiff’s claims.2

A. Plaintiff’s Failure to Warn Claims (Counts II, VI) and 

Misrepresentation Claims (Counts VIII, XII) Fail as a Matter of Law. 

1. Bard Had No Duty To Warn about Comparative Risks. 

Plaintiff admits that, before treating Ms. Booker, Dr. D’Ayala knew the potential 

complications of the G2 Filter that were included in the IFU. (Pl. CSOF ¶ 8.) Indeed, 

Plaintiff admits that the IFU for the G2 Filter warns of the precise risks of complications 

that Plaintiff experienced. (Pl. CSOF ¶ 5; Cf. Pl. Br. at 1.) Specifically, she admits 

“[t]here is no dispute Dr. D’Ayala was aware the filter he implanted in Ms. Booker could 

fracture; nor is there any dispute that her filter’s IFU included a risk of fracture as a 

potential complication.” (Pl. Br. at 14.) Rather, Plaintiff challenges the adequacy of 

“Bard’s warnings . . . because they did not disclose that the risk of fracture for the G2 was 

1

 As part of her response papers, Plaintiff filed 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. 

2

 Bard is entitled to summary judgment on Plaintiff’s Manufacturing Defect (Counts I, V) 

and Failure to Recall/Retrofit (Count VI) claims, as Plaintiff has now withdrawn them. 

(Pl. Br. at 1 n.1.) Despite refusing to withdraw them during pre-motion meet-and-confer 

efforts when Bard identified the total absence of factual and legal support, Plaintiff now 

admits in Response to Bard’s Motion what she knew then, that she lacked any evidence to 

support her manufacturing defect claims, (Pl. CSOF ¶¶ 33-35), and that her recall/retrofit 

claim was not recognized under Georgia law. Plaintiff’s attorneys were well aware of 

those same facts during the meet and confer process, as evidenced by their withdrawal of 

the same claim under the same law in the Jones case. 

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greater than the risk of the same complication for its competitors’ devices or as against the 

SNF.” (Id.) Yet Plaintiff cites no case law supporting a duty to include the type of 

information that she generally demands, such as “warnings that its filters fractured, 

migrated, tilted, and perforated patients’ IVCs at rates significantly higher than competitor 

IVC filters and Bard’s SNF.” (Pl. Br. at 6.) Further, Plaintiff does not address the case 

law cited in Bard’s Motion that rejected arguments that manufacturers had a duty to 

include comparative rate information in their warnings. 

Instead, Plaintiff conflates the issues of duty to warn with adequacy of the warning. 

The existence of a duty to warn is a question of law and is informed by logic, science, and 

public policy. See Certainteed Corp. v. Fletcher, 300 Ga. 327, 330, 794 S.E.2d 641, 645 

(2016). Plaintiff argues that Bard had a duty to warn physicians that the G2 Filter “has 

significantly higher complication rates than the rates for competitor IVC filters and the 

SNF.” (Pl. Br. at 12.) The cases that Plaintiff cites, however, do not address whether 

such a duty exists, but rather focus on whether adequacy of the warning at issue was a 

question of fact for the jury. The predicate issue, however, is whether such a duty to warn 

exists. As a matter of logic, science, and public policy, Bard submits that it has no duty to 

warn about comparative rates. 

First, there is no Georgia law creating a duty on a manufacturer to provide 

comparative rates of complication for its product to other similar products on the market. 

Rather, as discussed on page 9 of Bard’s Motion, courts that have addressed the issue 

have found that pharmaceutical and medical-device manufacturers have no duty to warn 

physicians about the risks attendant to other products. Plaintiff did not address any of 

these cases in her Response, and none of the cases that she cites hold that such a duty 

exists.3

3 Watkins v. Ford Motor Co., 190 F.3d 1213, 1219-20 (11th Cir. 1999) (the court did not 

discuss whether Ford had a legal duty to provide comparative warnings, but noting that 

where the rollover risk for the Bronco II was higher than other cars, “a reasonable fact 

finder could conclude that Ford was required to provide a more detailed warning for the 

vehicle”); Cason v. C.R. Bard, Inc., No. 1:12-CV-1288-MHS, 2015 WL 9913809, at **3-

4 (N.D. Ga. Feb. 9, 2015) (although Bard argued that it had no duty to warn about 

comparative rates, as noted by the court, the court never addressed Bard’s argument, 

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Second, Bard is unaware of any FDA regulation that would require (or even 

permit) it to warn doctors about comparative rates of risk between the G2 Filter and other 

IVC filters. Any comparative rate information that Plaintiff claims Bard should have 

included in its warnings is almost certainly precluded by FDA regulations. In the closely 

related pharmaceutical context, the FDA places strict limitations on when comparative 

claims can be made, requiring that such comparative information be the result of 

“adequate and well-controlled studies.” See 21 C.F.R. § 201.57(c)(7) (2011); 21 C.F.R. § 

314.126(b) (2011); Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466, 2473 (2013) (state 

law statute requiring labeling changes preempted). Moreover, Plaintiff’s regulatory 

expert, Dr. Parisian, testified that, per FDA regulations, Bard would not be permitted to 

provide the rates Plaintiff purports to require in her warnings. (Dep. Tr. Dr. Suzanne 

Parisian, 71:5-18, Sept. 25, 2014 (“the MAUDE database, it can be used for certain things, 

but it’s not – you wouldn’t use it across industry to come up with the incidence rate. And 

it says it on the database; don’t use it as an incidence rate, but you can come up with – you 

can use it for certain things, but I wouldn’t use it for that”), attached as Exhibit N). 

Further, generating reliable comparative adverse event rates across IVC filters is 

impossible, and therefore the rates are not the result of “adequate and well-controlled 

studies.” If Plaintiff’s proposed comparative warnings standard were imposed on Bard 

when the FDA’s regulations most likely would prevent Bard from providing such 

comparative warnings, then the Plaintiff’s claim would be preempted by federal law. See 

Bartlett, 133 S. Ct. at 2473; Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (state 

requirements preempted if “‘different from, or in addition to’ the requirements imposed 

by federal law”); Bass v. Stryker Corp., 669 F.3d 501, 505-06 (5th Cir. 2012) (affirming 

instead skipping ahead to whether the warning was adequate); Cisson v. C.R. Bard, Inc., 

No. 2:11-CV-00195, 2013 WL 5700513, at *7 (S.D. W. Va. Oct. 18, 2013), aff’d sub 

nom. 810 F.3d 913 (4th Cir. 2016) (not addressing whether Bard had a duty to warn about 

rate and severity of complications, instead summarily noting that the issue was whether 

Bard’s warnings were adequate, which is a question of breach; thus, the court skipped the 

predicate step of whether a duty actually existed to warn about rates of complications); In 

re Mentor Corp., 711 F. Supp. 2d 1348, 1377 (M.D. Ga. 2010) (discussing adequacy of 

warning only, not whether a duty existed to warn about comparative rates of 

complication). 

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order dismissing failure to warn claims, on the basis they were foreclosed by Riegel). 

Third, meeting Plaintiff’s demand that Bard provide comparative warnings to 

doctors is impossible. The data is inherently unreliable for defining actual rates. The 

FDA explicitly states that “MAUDE data is not intended to be used either to evaluate rates 

of adverse events or to compare adverse event occurrence rates across devices.” (MAUDE 

– Manufacturer and User Facility Device Experience, at https://www.fda.gov/ 

MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdve

rseEvents/ucm127891.htm (last accessed Oct. 23, 2017)).4 Even Plaintiff’s biostatistician 

expert, Dr. Betensky, recognizes in her analysis that she is not deriving actual rates of 

complication, rather calling them “Reporting Risk Ratios.” 

Finally, even if rates for adverse events were discernible, because they would be 

discernible only through adverse event reports, the rates would change many times each 

day. Adverse events for IVC filters (the numerators in the rates calculation) are reported 

throughout the country. Moreover, Bard reports to the FDA the events that it receives 

through new legal complaints, and certain events reported in medical literature. 

Additionally, Bard’s filters and other filters (the denominators in the rates calculation) are 

implanted many times throughout the country each day, thereby altering the denominator 

in any rate calculation. Thus, throughout each day, the numbers needed to calculate the 

comparative rates change for every IVC filter. By the time that Bard could compile the 

4 See also Goldman (writing for the U.S. Food and Drug Administration), Limitations and 

Strengths of Spontaneous Reports Data, 20 Clinical Therapeutics C40 (1998) (discussing 

the many biases in spontaneous adverse event reports, and concluding that “Numerator 

and denominator limitations make incidence rates computed from spontaneously reported 

data problematic, if not completely baseless”), attached as Exhibit O; FDA, Guidance for 

Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

(Mar. 2005) (discussing the numerous biases inherent in adverse event reporting, and 

concluding that “Comparisons of reporting rates and their temporal trends can be 

valuable, particularly across similar products or across different product classes prescribed 

for the same indication. However, such comparisons are subject to substantial limitations 

and interpretation because of the inherent uncertainties in the numerator and denominator 

used. As a result, FDA suggests that a comparison of two or more reporting rates be 

viewed with extreme caution and generally considered exploratory or hypothesisgenerating. Reporting rates can by no means be considered incidence rates, for either 

absolute or comparative purposes.”), attached as Exhibit P. 

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comparative rate data, calculated comparative rates of risk, and informed doctors of the 

results, the rates would be wrong. Bard then would need to issue revised warnings 

documents, which likewise would be wrong by the time they were issued to doctors. 

Considering the volume of filter-related complications across all devices that can 

potentially occur each year and that tens of thousands of IVC filters are placed each year, 

Plaintiff’s demand for comparative rates warnings is simply impossible to meet. 

For all of these reasons, the Court should decline to impose a duty on Bard to warn 

about comparative rates of complications, and should grant Bard summary judgment on 

Plaintiff’s failure-to-warn claims. 

2. Bard’s Warnings Were Adequate as a Matter of Law. 

Because Plaintiff admits that the IFU for the G2 Filter warns of the precise risks of 

complications that Plaintiff alleges she experienced, Bard’s warnings were adequate as a 

matter of law. Although adequacy of warnings is sometimes a question of fact, in 

situations such as these, Georgia courts have found such warnings adequate as a matter of 

law. See, e.g., Thornton v. E.I. Du Pont De Nemours & Co., Inc., 22 F.3d 284, 289 (11th 

Cir. 1994) (applying Georgia law, and finding “[t]he product carried a warning of the 

hazards connected with its use. Said warning was reasonably calculated to reach the 

average user and contained clear and simple language. . . . Summary judgment is 

appropriate where, as in this case, the facts support only one conclusion, that is, the 

warning and its communication were adequate.”); Lakey v. Mentor Corp., Civil Action 

No. 1:05–cv–929–TCB, 2007 WL 4811929, at *4 (N.D. Ga. Mar. 30, 2007) (finding that 

failure to warn claim was barred because plaintiff alleged that product caused infection 

and product insert sheet warned of the risk of infection). As discussed in Bard’s Motion, 

the IFU’s warnings clearly conveyed the risks of Bard’s filter, and Dr. D’Ayala was aware 

of those risks when prescribing the G2 as a retrievable filter.5 Therefore, the Court should 

5

 Plaintiff’s assertion that “Dr. D’Ayala testified that he read and relied upon the G2 IFU,” 

is incorrect. (Pl. Br. at 6.) Plaintiff has no evidence that Dr. D’Ayala “read” the G2 IFU. 

(Cf. Pl. Supp. OSOF ¶ 331). Dr. D’Ayala only testified that he agreed he had the G2 IFU 

“available” to him before he implanted Ms. Booker. (Pl. CSOF ¶ 4.) Additionally, 

Plaintiff’s assertions that Dr. D’Ayala intended her G2 filter to be a permanent device, (Pl. 

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find the warnings adequate as a matter of law. 

Additionally, while Plaintiff argues for several pages about alleged information 

contained in Bard documents, she never identifies the precise information/language 

Bard’s warnings should have contained. See Nolley v. Greenlee Textron, Inc., No. CIVA 

1:06-CV-228 MHS, 2007 WL 5369405, at *6 (N.D. Ga. Dec. 6, 2007) (granting summary 

judgment because “given the Court’s exclusion of [the plaintiff’s expert’s] testimony, 

plaintiff lacks essential expert evidence as to what alternative warnings should have been 

given and whether such warnings would have been heeded. . . . Indeed, without [the 

expert’s] opinion, the jurors will not be presented with alternative warnings and will have 

no means by which to adjudge whether the existing warnings were adequate.”) Because 

Plaintiff has provided no evidence by which a jury can determine whether the warnings 

were adequate, summary judgment is appropriate on her failure to warn claims. 

3. Plaintiff Cannot Prove Proximate Causation. 

As Bard discussed in its Motion, an element of Plaintiff’s failure to warn claim is 

that a purported proper warning would have caused a different product to be used, thereby 

avoiding the Plaintiff’s alleged injuries. (See Mot. at 10-11.) Plaintiff presents no 

evidence to satisfy this element of her claim. As such, Plaintiff’s failure to warn claims 

fail as a matter of law. 

Plaintiff did not ask Dr. D’Ayala during his deposition whether a different warning 

would have changed his decision to use the G2 Filter for Ms. Booker. Instead, Dr. 

D’Ayala was asked would he have “liked to have known” certain information contained in 

internal Bard documents regarding the Recovery Filter “as a doctor who is implanting 

Br. at 3, 12), ignores his testimony on cross examination that, based on his own language 

in the operative note identifying the device as a retrievable filter, he intended the G2 to be 

retrieved when she was no longer contraindicated. (Dr. D’Ayala Dep. Tr., 89:18 to 93:3, 

Mar. 21, 2017, (“D’Ayala Dep. Tr. Supp.”) attached as Exhibit C-1.) This is true even 

though the G2 was not cleared for retrievable indication in 2007, because “I can tell you 

that we had retrieved a number of these G2 filters.” (Id. at 84:22 to 85:11.) Because 

Plaintiff has taken Dr. D’Ayala’s testimony out of context, and contends that Bard has 

done the same, Bard submits his entire deposition transcript. 

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Recovery filters.” (Pl. Supp. OSOF ¶¶ 332-339; Pl. Br. at 6-7.)6 Ms. Booker did not 

receive a Recovery Filter. For example, Plaintiff’s counsel asked whether information 

contained in the Recovery Filter Migration Remedial Action Plan is “important to you to 

know prior to implanting a Recovery Filter?” (Id. at ¶ 337 (Pl. Ex. B-B, D’Ayala Dep. at 

37:22-40:2 (emphasis added).) Contrary to Plaintiff’s inaccurate assertion, Dr. D’Ayala 

never testified that “He may have used a filter other than a Bard Filter.” (Id. at ¶ 335.) 

His complete testimony relates, again, to information contained in an internal Bard 

document showing reported complication rates for the Recovery Filter, not the G2 Filter 

at issue here: 

Q. This is a health hazard evaluation . . . dated December 

17th, 2004 . . . And this is Recovery Filter Consultants 

Report . . . to Bard of adverse events associated with 

the Recovery . . . Would this have been important 

information for you to know, that is, a doctor who is 

implanting Recovery filters, that those filters [Recovery 

Filters] had a greater risk of fracture that’s four and five 

times higher than the competitor filters? 

A. Yes. 

Q. Is that the type of information that would influence 

your prescribing habits, whether you would use that 

filter, a Bard filter, or another filter? 

A. Yes. 

(Id. (Pl. Ex. B-B, D’Ayala Dep. at 36:12 to 37:20 (emphasis added; objections omitted).7

6

 Plaintiff’s only questioning related to information specific to the G2 filter admittedly 

was based on information that post-dated Ms. Booker’s implant by three years. (See Pl. 

Supp. OSOF ¶ 340; Ex. C-1, D’Ayala Dep. Tr. Supp. at 61:6-25 (“Q. I know this is dated 

2010, but I’m going to ask you the question for purposes of a hypothetical, that is, had you 

known this information of this conclusion [in the 2010 Nicholson article], would that have 

influenced your prescribing habits and the use of the G2 with Ms. Booker?” A. Yes.”).) 

Plaintiff relied on the reported (12%) and extrapolated (25%) fracture rates in the 2010 

Nicholson article to ask whether Dr. D’Ayala “would have used a G2” had he known back 

in 2007 that there was a 12 or 25 percent risk of filter fracture with the G2. (Pl. Supp. 

OSOF ¶ 340.) Dr. D’Ayala questioned the science behind the conclusions in the 

Nicholson article, (Id., Pl. Ex. B-B, D’Ayala Dep. at 70:6-8), and admitted that this 

information from 2010 was not available to him when he implanted the G2 filter in Ms. 

Booker in 2007. (Ex. C-1, D’Ayala Dep. Tr. Supp. at 116:11-21.) 

7

 Plaintiff relies on other testimony that is not admissible (and was properly objected to at 

the time it was solicited) because the question had no foundation and mischaracterized the 

doctor’s previous testimony. (See Ex. C-1, D’Ayala Dep. Tr. Supp. at 61:6-25); see also 

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In fact, Dr. D’Ayala admitted that it would be “[d]ifficult to say with certainty” 

whether the information he was shown would have changed his prescribing decision, and 

that it “would depend upon what other filters we had at the time and what their problems 

would have been.” (SSOF at ¶ 11). Plaintiff’s evidence that he “may have used a filter 

other than a Bard filter,” (Pl. Supp. OSOF ¶ 335), 8 “raises merely a conjecture or 

possibility,” which is insufficient to establish causation as a matter of law. See, e.g., R & 

R Insulation Servs., Inc. v. Royal Indem. Co., 705 S.E.2d 223, 233 (Ga Ct. App. 2010) 

(“[P]laintiff must present evidence supporting a reasonable inference that the warning 

provided by the defendant would prevent the injury. An inference cannot be based upon 

evidence which is too uncertain or speculative or which raises merely a conjecture or 

possibility.”); Nelson v. Pima Comm. College, 83 F.3d 1075, 1081-82 (9th Cir. 1996) 

(citations omitted) (“[M]ere allegation and speculation do not create a factual dispute for 

purposes of summary judgment.”); Watkins v. Eli Lilly & Co., No. 1:08-CV-1665, 2010 

WL 11493785, at *8 (N.D. Ga. Mar. 31, 2010) (citations omitted) (Plaintiff must prove 

“but for the inadequate warning, the physician would not have used or prescribed the 

product. If a plaintiff fails to meet this burden, the causal connection is broken, and 

plaintiff cannot prove that the breach was the proximate cause of his injuries.”).

Critically, Dr. D’Ayala unequivocally testified that he does not rely on information 

contained in a medical device manufacturer’s internal documents, or their preliminary or 

internal investigations, when deciding which IVC filter to use because such incomplete 

information is unreliable, misleading, and could negatively impact his practice. (See Pl. 

CSOF ¶ 14.) Contrary to Plaintiffs’ claim, this testimony is not taken out of context. 

Pl. Supp. OSOF ¶ 339 (Pl. Ex. B-B, D’Ayala Dep. at 63:10 to 64:7).) This inadmissible 

testimony cannot be used to oppose summary judgment. 

8

 Dr. D’Ayala’s testimony that he would “have used a different device if I knew at the 

time that the Bard filter was not ideal or as good as some of the other implants,” or “if 

there was a different filter that I knew of that was better, in terms of its safety profile,” (Pl. 

Supp. OSOF ¶¶ 338-339), is insufficient to create a question of fact because it is 

speculation. Similarly, his testimony based on information that post-dated Ms. Booker’s 

implant by three years, (see id. at ¶ 340), is insufficient to support proximate causation as 

a matter of law. 

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Rather, it clarifies Dr. D’Ayala’s testimony earlier in his deposition regarding whether the 

Recovery Filter information he was shown would have changed his prescribing habits. 

Importantly, “Plaintiff does not dispute that this testimony was given by Dr. D’Ayala.” 

(Id.) Instead, Plaintiff asks this Court to consider his earlier, speculative testimony based 

on mischaracterized facts, from internal Bard documents, over his later clarified 

testimony.

For each of these reasons, the Court should find the G2 Filter’s warnings adequate 

as a matter of law. 

4. Plaintiff Offers No Legal Authority For Separate Products Liability 

Misrepresentation Claims (Counts VIII, XII). 

Plaintiff baldly asserts that “misrepresentation claims survive summary judgment 

in Georgia.” (Pl. Br. at 15.) But “Plaintiff does not provide any authority to support its 

negligent misrepresentation claim, and summary judgment on Plaintiff’s negligent 

misrepresentation claim [should be] granted.” Gaddy v. Terex Corp., No. 1:14-CV-1928-

WSD, 2017 WL 3476318, at *5 (N.D. Ga. May 5, 2017) (“This Court previously 

determined that, under Georgia law, ‘there [are] no misrepresentation claims for products 

liability distinct from failure to warn claims.’ Brazil v. Janssen Research & Dev. LLC, 249 

F. Supp. 3d 1321, 1340 (N.D. Ga. 24, 2016) (citing Swicegood v. Pliva, Inc., 543 F. Supp. 

2d 1351, 1357 (N.D. Ga. 2008) (“In the absence of clear precedent, I am not prepared to 

recognize the viability of misrepresentation claims distinct from products liability or 

failure to warn claims.”)”). 

“[C]ourts in many states [including Georgia] have expressly rejected the argument 

that misrepresentation claims are distinct from product liability or failure-to-warn claims. 

The rule in these states is that all claims arising from the use of a product are properly 

characterized as ‘product liability claims.’” In re Darvocet, Darvon & Propoxyphene 

Prod. Liab. Litig., 856 F. Supp. 2d 904, 910 (E.D. Ky. 2012) (citing Swicegood, 543 F. 

Supp. 2d at 1357), aff’d sub nom. In re Darvocet, Darvon, & Propoxyphene Prod. Liab. 

Litig., 756 F.3d 917, 943 (6th Cir. 2014) (predicting based on the Swicegood opinion that 

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the Georgia Supreme Court would construe Plaintiffs’ misrepresentation claims as product 

liability claims).

Plaintiff’s attempt to distinguish the case law that Bard cited is unavailing. The 

Swicegood court specifically distinguished Potts v. UAO-GA AG CHEM, Inc., 567 S.E.2d 

316, 318 (Ga. Ct. App. 2002) because the misrepresentation claim that the Potts court 

contemplated did not “deal[] with a products liability claim,” but rather the employer’s 

misrepresentation about the plaintiff’s “exposure to chemicals.” Swicegood, 543 F. Supp. 

2d at 1357. Therefore, Potts does not support Plaintiff’s misrepresentation claims here as 

they are not founded on any alleged misrepresentations regarding her specific exposure to 

the Filter. Instead, like the Swicegood court found, Plaintiff’s misrepresentation claims 

are simply “‘masquerading’ as a products-liability claim,” (Pl. Br. at 16.), and do not 

differ from her failure-to-warn claims. Put simply, “Plaintiff does not address the legal 

basis for her claim, cite any case law, or distinguish the cases cited by Defendants. Nor 

does Plaintiff explain how a negligent misrepresentation claim differs from a failure to 

warn claim.” Brazil, 249 F. Supp. 3d at 1340 (dismissing misrepresentation claim).

Further, even if Georgia law recognized separate products liability 

misrepresentation claims, Plaintiff’s claims fail on the merits. (See Mot. at 6 n.3.) 

Plaintiff offers no evidence of the required elements, including scienter and justifiable 

reliance. (See Pl. CSOF ¶¶ 10, 17, 29-31); 9see, e.g., Potts, 567 S.E.2d at 319; 

Swicegood, 543 F. Supp. 2d at 1357 (justifiable reliance is an essential element of both 

negligent and fraudulent misrepresentation under Georgia law). Thus, Bard is entitled to 

summary judgment on Plaintiff’s misrepresentation claims. 

9

 Plaintiff admits that Dr. D’Ayala does not recall specific conversations with any Bard 

sales representatives, including Robert Ferrara. (See Pl. CSOF ¶ 10.) Therefore, the Court 

should ignore Plaintiff’s thinly-veiled attempt to create a question of fact with Robert 

Ferrara’s deposition testimony. (See Pl. Br. at 7-8; Pl. Supp. OSOF ¶¶ 345-358.) 

Similarly, Dr. D’Ayala testified as to what information, if any, would have impacted his 

decision to prescribe the G2 Filter in this case, which is the only opinion that is relevant 

on this issue. All other testimony should be ignored. (See Pl. Br. at 8-9.) 

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B. Plaintiff’s Negligence Per Se Claim (Count IX) Fails. 

Plaintiff’s negligence per se cause of action fails because she admittedly is using a 

Georgia statute as a vehicle to privately enforce alleged FDCA violations. (See Pl. Br. at 

16 (“Count IX of Plaintiff’s Master Complaint alleges that Bard was negligent per se and 

based upon violation of several sections of the Food Drug and Cosmetic Act including but 

not limited to, 21 U.S.C. §§ 321, 331 and 352, and various attendant regulations, 

specifically 21 C.F.R. §§ 1.21, 801, 803, 807 and 820.”). The FDCA, however, does not 

provide a private right of action for a defendant’s violation of its provisions. See Merrell 

Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 810 (1986). 

Instead, “all such proceedings for the enforcement, or to restrain violations, of this 

chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a). This 

Section “leaves no doubt that it is the Federal Government rather than private litigants 

who are authorized to file suit for noncompliance with the medical device provisions.” 

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001). Accordingly, 

where “the existence of these federal enactments is a critical element in [Plaintiff’s] case,” 

and where Plaintiff’s claims “exist solely by virtue of the FDCA . . . requirements,” state 

law claims are impliedly preempted by the FDCA. Id. at 352-53 (finding fraud-on-the 

FDA claims involving 510(k)-cleared device impliedly preempted). 

Negligence per se raises precisely the type of state-law claim Buckman held 

preempted, because such claims “exist solely by virtue” of the FDCA, and have FDA 

violations as a “critical element.” Id.; see generally Arvizu v. Medtronic Inc., 41 F. Supp. 

3d 783, 793 (D. Ariz. 2014) (“The Court concludes that Plaintiffs’ [negligent off-label 

promotion] claims are impliedly preempted because they ‘exist solely by virtue’ of FDCA 

requirements. Allowing Plaintiffs’ claims to go forward would be essentially authorizing 

an impermissible action to enforce the provisions of the FDCA.”). 

Plaintiff fundamentally misunderstands the Supreme Court’s preemption 

jurisprudence, and misconstrues Leonard v. Medtronic Inc., 2011 WL 3652311 (N.D. Ga. 

Aug. 19, 2011). The Leonard Court held that the plaintiffs’ negligence per se claim was 

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“impliedly preempted by § 337(a),” based on the implied preemption principles 

established in Buckman, because it sought to privately enforce the FDCA. Id. at *8; see 

also Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017) (“[I]mplied 

preemption prohibits state-law claims that seek to privately enforce duties owed to the 

FDA.”). Contrary to Plaintiff’s contention, (see Pl. Br. at 17), this holding was not 

predicated on the device’s PMA status (which would be entitled to express preemption 

under § 360k(a)). Moreover, implied preemption is not limited to PMA devices, as 

Plaintiff seems to suggest, but rather applies equally to 510(k) devices. Indeed, the very 

device at issue in Buckman was a 510(k) device. Thus, Leonard is directly applicable 

here, Plaintiff’s negligence per se cause of action is impliedly preempted, and summary 

judgment is appropriate.10

C. Plaintiff Has Offered Insufficient Evidence To Bring a Punitive 

Damages Claim. 

Plaintiff has failed to meet her high burden to establish her punitive damages claim 

because (1) she has not shown that her allegations involving different products and 

10 Plaintiff argues that O.C.G.A. § 51–1–6 circumvents this preemption, and provides a 

separate cause of action, but it does not. A large body of case law runs counter to her 

argument, finding that O.C.G.A. § 51–1–6 is simply a codification of the negligence per 

se doctrine, and a separate statute providing a cause of action is still required. See e.g., 

Hanover Ins. Co. v. Carroll, No. 1:13–cv–01802–SCJ, 2014 WL 5472520, at *7 (N.D. 

Ga. Mar. 5, 2014) (“[S]upport for a claim under § 51–1–6 must be found in a legislative 

enactment outside of § 51–1–6.”); Coleman v. H2S Holdings, LLC, 230 F. Supp. 3d 1313, 

1321 (N.D. Ga. 2017) (“[N]one of the three Georgia statutes that Plaintiff claims Oasis 

violated provides a private right of action. One is a criminal statute, and the other two 

‘simply set forth general principles of tort law.’ They authorize ‘the recovery of damages 

for the breach of a legal duty otherwise arising, though not expressly stated, under a 

statute or common law.’ Since Oasis violated no such duty, those statutes have no 

application here.”) (internal quotations omitted); see also, Dist. 65 Ret. Tr. for Members 

of Bureau of Wholesale Sales Representatives v. Prudential Sec., Inc., 925 F. Supp. 1551, 

1561 (N.D. Ga. 1996) (finding fraud and negligence claims brought under O.C.G.A. § 51–

1–6 were preempted by ERISA). The lone case Plaintiff cites in support of her position, 

Amick v. BM & KM, Inc., 275 F. Supp. 2d 1378 (N.D. Ga. 2003), also recognizes that 

“[w]here the cited statute does not govern the relationship between the parties, no cause of 

action exists [under O.C.G.A. § 51–1–6], and recovery of damages based on violation of 

that particular statute is unwarranted.” Id. at 1382. The only statute that Plaintiff 

identifies is the FDCA, which does not permit a private right of action. 

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complications11 are substantially similar to the G2 Filter complications at issue in Ms. 

Booker’s case, and (2) Plaintiff has not shown that Bard acted with “conscious 

indifference” by doing “nothing,” because Plaintiff concedes that the G2 design changes 

were intended to improve fracture and migration resistance. Punitive damages are only 

assessed in extreme cases in Georgia, and require clear and convincing evidence of 

“willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care 

which would raise the presumption of a conscious indifference to the consequences” of 

the tortious act. O.C.G.A. § 51-12-5.1(b). 

Plaintiff suggests that a “conscious indifference to the consequences” requires less 

than some intentional act. (Pl. Br. at 22.) But, Georgia law is clear that “conscious 

indifference to consequences means an intentional disregard of the rights of another, 

knowingly or willfully. COMCAST Corp. v. Warren, 650 S.E.2d 307, 311 (Ga. Ct. App. 

2007) (citing Read v. Benedict, 406 S.E.2d 488 (Ga. Ct. App. 1991)) (emphasis added); 

see also Georgia Farm Bureau Mut. Ins. Co. v. Miller, 473 S.E.2d 189, 191 (Ga. Ct. App. 

1996) (“The latter expression relates to an intentional disregard of the rights of another 

knowingly or willfully disregarding such rights.”). Thus, even clear and convincing 

evidence of gross negligence will not support an award of punitive damages. COMCAST, 

650 S.E.2d at 311. 

1. Plaintiff Cannot Support Her Punitive Damages Claim with Other 

Incidents Involving Different Products and Complications Without 

Showing Substantial Similarity. 

“In product liability actions, evidence of other incidents involving the product is 

admissible, and relevant to the issues of notice of a defect and punitive damages, provided 

there is a showing of substantial similarity. Without a showing of substantial similarity, 

the evidence is irrelevant as a matter of law.” Ray v. Ford Motor Co., 514 S.E.2d 227, 

11 Plaintiff uses the non-descript terms “product,” “device,” or “its retrievable line of IVC 

filters” to give the misimpression the cited information is not related exclusively to the 

Recovery Filter. (Cf. Pl. Br. at 20; Pl. OSOF ¶¶ 29, 41, 45, 52, 53.) 

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230 (Ga. Ct. App. 1999) (emphasis added). Ray, which is instructive here, involved 

inadvertent vehicle motion of a 1989 Mustang by allowing the ignition key to be removed 

without the vehicle being in the “park” position. Id. at 229. Ford kept a database, much 

like FDA’s MAUDE database on which Plaintiff relies, of prior instances of inadvertent 

vehicle movement in cars lacking the ignition locking device. But, the prior “incidents 

were not confined to any particular model or year and that some of the information dated 

back to the 1960s. Moreover, the information was encoded into the database by 

employees who had no personal knowledge of the events, but who were simply instructed 

to input the information from the various source documents into designated codes. The 

codes utilized were extremely broad, and any one designation could include a wide variety 

of fact patterns.” Id. at 230-31. “The database also failed to take into account various 

underlying factors-such as whether the parking brake was engaged, whether the car was 

on level ground or an incline or whether the vehicle was unoccupied-because this 

information was unknown or missing from the source documents.” Id. Furthermore, “the 

information in the database has not been verified, and at least some of the information is 

known to be inaccurate. Ford had also determined that the database contained a number 

of duplicate entries.” Id. 

In other words, many of the problems inherent in the MAUDE database were also 

present in Ray. (See e.g., Doc. Nos. 7288; 8221 (discussing various reliability issues 

comparing rates between Bard’s retrievable filters, the SNF, and using the MAUDE 

database, in Bard’s motion and reply in support to exclude Dr. Betensky).) The Georgia 

Court of Appeals found no error in the trial court excluding this evidence and declining to 

consider it for the plaintiff’s punitive damages claim. Likewise, here, Plaintiff’s evidence 

of other incidents cannot support her punitive damages claim because she has made no 

showing that the documents and testimony that she cites in her Response regarding Bard’s 

other filters and complications are substantially similar to the complications that occurred 

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with the G2 Filter that Ms. Booker received.12 See State Farm Mut. Auto. Ins. Co. v. 

Campbell, 538 U.S. 408, 422-23 (2003) (“A defendant’s dissimilar acts, independent from 

the acts upon which liability was premised, may not serve as the basis for punitive 

damages.”). As such, the Court should disregard all such evidence when considering 

whether the Plaintiff has created a question of material fact concerning her punitive 

damages claim. 

2. Plaintiff Has Not Shown that Bard Exhibited “Conscious 

Indifference” By Doing “Nothing,” Because Plaintiff Concedes The 

G2 Filter Design Was Intended to Improve Fracture/Migration 

Resistance. 

Plaintiff cannot establish that Bard acted with a “conscious indifference” that 

would justify imposing punitive damages. Plaintiff relies on Cason, which in turn relied 

exclusively on Cisson, for arguing “that punitive damages are available where a 

manufacturer knows that its product is potentially dangerous and chooses to do nothing to 

make it safer or to warn consumers.” (Pl. Br. at 22 (quoting Cason, 2015 WL 9913809, at 

*6 (emphasis original)).) But even the Cisson court acknowledged that “[a]ny care taken 

to prevent injuries would not rise to an ‘entire want of care’ and could not, by definition, 

exceed gross negligence.” Cisson v. C.R. Bard, Inc., No. 2:11-CV-00195, 2013 WL 

5700513, at *13 (S.D.W. Va. Oct. 18, 2013); COMCAST, 650 S.E.2d at 311 (clear and 

convincing evidence of gross negligence will not support an award of punitive damages). 

Despite Plaintiff’s claim that the G2 was “a newer but equally defective design” to 

the Recovery Filter, (Pl. Br. at 20), Plaintiff also argues that Bard developed the G2 Filter 

“with the objective of addressing and minimizing problems of filter migration and filter 

12 Plaintiff does not cite any cases to support the proposition that “substantial 

equivalence,” as defined by FDA regulations and applied in the 510(k) process for product 

clearance, constitutes “substantial similarity” for purposes of punitive damages. In re 

Bair Hugger Forced Air Warming Devices Prod. Liab. Litig., No. MDL152666JNEFLN, 

2017 WL 1373257, at *2 n.1 (D. Minn. Apr. 13, 2017) (acknowledging “[a]n FDA 

finding of substantial equivalence in the § 510(k) premarket approval process does not 

necessarily mean that the device under consideration has the same technological 

characteristics as the predicate device.”). “Without a showing of substantial similarity, 

the evidence is irrelevant as a matter of law.” Ray, 514 S.E.2d at 230. 

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arm fracture with the Recovery.” (Pl. OSOF ¶ 63.) Indeed, Bard made several 

dimensional changes to the design of the Recovery when developing the G2 Filter aimed 

at improving fracture and migration resistance. (Id. at ¶ 313.) While Plaintiff disputes 

whether this “redesign” was effective, (Pl. Br. at 21, 23), Bard’s intended design 

improvements, and substantial investment in making those difficult improvements, cannot 

be considered “nothing” or “an entire want of care which would raise the presumption of a 

conscious indifference to the consequences.” O.C.G.A. § 51-12-5.1(b).13

Plaintiff’s other assertion is that “Bard never . . . implemented known design 

improvements to address alarming rates of filter migration and perforation,” “even when, 

in 2008, it identified significant design changes to the G2 that were essential to the safety 

of the device.” (Pl. Br. at 21.) “Bard did not seek and receive 510(k) clearance for its 

Meridian filter . . . which included caudal anchors (to resist caudal migration) until August 

2011.” (Pl. Supp. OSOF ¶ 367.) Plaintiff, in essence, alleges that Bard should be liable 

for punitive damages because it did not invent and bring to market its subsequent 

generation filters by June 2007 when Ms. Booker received her filter. This assertion 

ignores that these design changes were not available given the extensive design, testing, 

and regulatory clearance processes that were required before these design changes could 

be safely and legally implemented.14 Put simply, Plaintiff has failed to meet her high 

burden under Georgia law to “present some evidence of ‘willful misconduct, malice, 

fraud, wantonness, oppression, or that entire want of care which would raise the 

presumption of conscious indifference to consequences.’” Edwards v. Ethicon, Inc., 30 F. 

Supp. 3d 554, 564 (S.D. W. Va. 2014) (citations omitted) (applying Georgia law and 

granting summary judgment on punitive damages claim). 

13 As Plaintiff points out, after the G2 was cleared for permanent indication on August 29, 

2005, (Pl. CSOF ¶ 36), Bard continued to evaluate and demonstrate the safety and 

efficacy of the device via the EVEREST clinical study. (Pl. OSOF ¶ 90.) 

14 Regarding its warnings, Bard’s position has always been it is precluded, both legally 

and practically, from including rates of complications in its IFUs. (See supra § A.1.) 

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Further, Georgia courts have dismissed punitive damages claims in factually 

similar circumstances more egregious than Plaintiff alleges against Bard. See, e.g., 

Hernandez v. Crown Equip. Corp., 92 F. Supp. 3d 1325, 1357 (M.D. Ga. 2015) (“[E]ven 

assuming that most or even all of the 741 accidents were sufficiently similar to the one 

here to impute constructive notice to Crown, forklift manufacturers clearly have to weigh 

the benefits of a particular design against the possibility that other risks might be 

increased” and “Crown was not consciously indifferent” to the risk because it made 

different design changes other than those proposed by the plaintiff); Moore v. Wright 

Med. Tech., Inc., No. 1:14-CV-62, 2016 WL 1298975, at *6 (S.D. Ga. Mar. 31, 2016) 

(finding that the plaintiff alleged a viable failure to warn claim because “Defendant 

published materials in which it claimed to have never experienced modular neck fractures 

since 1985, even though Defendant knew those statements were false,” but such evidence 

did not justify bringing a punitive damages claim); Stuckey v. N. Propane Gas Co., 874 

F.2d 1563 (11th Cir. 1989) (affirming the district court’s finding that “the evidence did 

not show [the manufacturer’s] culpability rose to a level sufficient to justify an award of 

punitive damages under Georgia law” even though “[t]he propane industry in general has 

long been familiar with this phenomenon of ‘odor fade’” such that in certain 

circumstances, leaking propane would become odorless and causing a greater risk of 

explosions). 

By contrast, every case cited by Cisson is factually distinguishable and shows that 

for punitive damages to be available, the defendant must truly do “nothing” in the face of 

likely and extreme injuries to show such an “entire want of care which would raise the 

presumption of conscious indifference to consequences.” O.C.G.A. § 51-12-5.1; see, e.g.,

Weilbrenner v. Teva Pharms. USA, Inc., 696 F.Supp.2d 1329, 1340; 1344 (M.D. Ga. 

2010) (finding that the “warning [for eye complications] was directed to adults only,” the 

FDA required separate warnings for pediatric patients, like the plaintiff, and the 

manufacturer knew of the condition could lead to blindness and did not warn of it); Mack 

Trucks, Inc. v. Conkle, 436 S.E.2d 635, 640 (Ga. 1993) (punitive damages appropriate 

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where evidence showed truck manufacturer ignored or rejected advice multiple times 

from its engineering division to reinforce frames, vetoed proposals to reinforce frames on 

new trucks, and failed to notify purchasers of frame problems); Ford Motor Co. v. 

Stubblefield, 319 S.E.2d 470, 476; 481 (Ga. Ct. App. 1984) (analyzing under a different 

legal standard whether a verdict was excessive, but finding that a manufacturer’s 

“conscious decisions to defer implementation of safety devices” to prevent fuel tanks 

catching fire in collisions, and that the manufacturer made “no effort was made to inform 

owners” without the safety devices of the risk, supported punitive damages); Ford Motor 

Co. v. Sasser, 618 S.E.2d 47, 58 (Ga. Ct. App. 2005) (manufacturer was aware of a 

greater risk to passengers from a seat latching system which caused the seats to collapse in 

collisions causing spinal cord injuries, knew of an internal “recommendation for a red 

indicator to alert customers to an unlatched seat, [] its own concerns that a recall may be 

in order, and despite its intent to change the design of the latching system to remedy this 

acknowledged safety defect,” “chose to do nothing to warn consumers” such as the 

plaintiff) (emphasis added); Reid v. BMW of N. Amer., 430 F.Supp.2d 1365, 1373-74 

(N.D. Ga. 2007) (finding punitive damages issue was for jury where the BMW defendants 

knew of problems with “radiator[s] explod[ing] causing boiling radiator fluid to spray 

onto” consumers, and there was “no evidence that any warnings existed”) (emphasis 

added).15

For all of these reasons, Plaintiff’s punitive damages claim fails as a matter of 

law.16

15 Plaintiff’s other authority, General Motors Corp. v. Moseley, 447 S.E.2d 302 (Ga. Ct. 

App. 1994) and Mascarenas v. Cooper Tire & Rubber Co., 643 F. Supp. 2d 1363 (S.D. 

Ga. 2009), are inapposite. Unlike in those cases, and contrary to Plaintiff’s allegation, 

Bard did not “ignore proven design changes” or “simple, relatively inexpensive 

solutions.” (Pl. Br. at 2.) To the contrary, Bard made substantial investments innovating 

and improving the design of its retrievable line of filters to meet continuing patient needs, 

as Plaintiff concedes, (See id. at 23), including conducting rigorous IDE clinical trials 

testing the safety and effectiveness of many of those designs. (See Defs. Mot. Summ. J. 

Re: Preemption (Doc. 5396), at 22-23; Defs. Reply Mot. Summ. J. Re: Preemption (Doc. 

7828), at 6-7.) 

16 Plaintiff’s other grounds for punitive damages based on Bard’s alleged failure to recall 

or stop selling its devices, for selling allegedly adulterated devices, and for allegedly 

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I. 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 Partial Summary Judgment. 

RESPECTFULLY SUBMITTED this 2nd day of November, 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. 

failing to provide FDA with complete information also fail. (See Pl. Br. at 23.) First, 

Plaintiff already conceded her failure to recall/retrofit claim. Second, “stop-selling 

claims” are preempted. See Bartlett, 133 S. Ct. at 2477. Third, “No private cause of 

action exists against [Bard] for selling ‘adulterated’ devices, no matter how the claim may 

be styled.” In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 2d 

1147, 1162 n.18 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. 2010). Finally, attacks 

on the quality of information underlying FDA’s decisions are impliedly preempted. E.g.,

Estes v. Lanx, Inc., 660 F. Appx. 260, 262 (5th Cir. 2016); Seufert v. Merck Sharp & 

Dohme Corp., 187 F. Supp. 3d 1163, 1180 (S.D. Cal. 2016); In re Incretin-Based 

Therapies Prod. Liab. Litig., 142 F. Supp. 3d 1108, 1130-31 (S.D. Cal. 2015). Therefore, 

any derivative punitive damages predicated on these allegations fail. 

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CERTIFICATE OF SERVICE 

I hereby certify that on this 2nd day of November, 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. 

Case 2:15-md-02641-DGC Document 8574 Filed 11/02/17 Page 21 of 21