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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’ C. R. BARD, INC. 

AND BARD PERIPHERAL 

VASCULAR, INC.’S REPLY IN 

SUPPORT OF ITS MOTION TO 

EXCLUDE THE OPINIONS OF 

REBECCA BETENSKY, PH.D. 

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested) 

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INTRODUCTION

There is no dispute Dr. Betensky did not account in any way for nearly a decade of 

data for the Simon Nitinol Filter (“SNF”) prior to 2000. Nor is there any dispute that Dr. 

Betensky admitted this failure could invalidate her opinions entirely. Plaintiffs do not 

argue that Dr. Betensky did not mean what she said. Plaintiffs do not argue that Bard 

somehow misquoted her admission or characterized it in a false light. 

The impact of Dr. Betensky’s concession left Plaintiffs grasping at straws, and their 

response was as confusing as it was unfounded. For the first time in their opposition brief, 

and with no documentary evidence or support whatsoever, Plaintiffs falsely accused Bard 

of both refusing to produce the data at issue, and/or intentionally “hiding” it through some 

trick in an Excel spreadsheet. The allegations are patently false. As set forth below, 

Plaintiffs have had this data in multiple spreadsheets since 2013, including in a 

spreadsheet that Dr. Betensky used. Moreover, an elementary understanding of Excel 

would have revealed that the information was never “hidden.” In any event, Plaintiffs 

never contacted Bard to inquire about these issues. Nor does Plaintiffs’ eleventh-hour 

attempt to explain away the data through the testimony of counsel or another expert in 

their opposition brief change the fact that Dr. Betensky failed to consider anything prior to 

2000. The lengths Plaintiffs are willing to go to distract from Dr. Betensky’s admission 

only underscore that her opinions are inadmissible under Daubert and Rule 702. 

Dr. Betensky’s opinions are equally inadmissible for the independent reason that 

she admitted she could not rule out alternative explanations for the reporting risk ratio 

(“RRR”) she calculated. Specifically, Plaintiffs do not address Dr. Betensky’s admission 

that she did not account for, let alone rule out, the possibility that differences in the way 

asymptomatic adverse events are detected between the SNF and retrievable filters could 

account for her findings. Nor do they contest Dr. Betensky’s failure to account for the 

potential that adverse events for the retrievable devices were subject to increased reporting 

because of litigation notoriety that did not impact the SNF. 

For these reasons, and as set forth more fully in Bard’s Motion and the reply 

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below, the Court should exclude Dr. Betensky.1

ARGUMENT 

I. Dr. Betensky’s Failure to Consider Pre-2000 SNF Data Admittedly Invalidates 

Her Opinions. 

As detailed in Bard’s Motion, Dr. Betensky’s failure to consider the first ten years 

of adverse event reports and sales data for the SNF is fatal to her analysis. (See Mot. at 

10-11.) Plaintiffs retained Dr. Betensky to opine that Bard’s retrievable filters have a 

higher risk of adverse events than Bard’s SNF. (See id. at 4.) To do so, she compared the 

proportions of adverse event reports for the various retrievable filters over sales to the 

proportions of adverse event reports for the SNF over SNF sales. But, instead of 

considering all of the adverse event reports and sales data for the SNF starting from its 

product launch, as she had done for each of the retrievable filters, she only utilized SNF 

data that post-dated 2000. (See Ex. C, MDL Dep. Tr., 124:18-22; 125:20 to 126:2.) She 

did so even though she was aware that “the SNF was launched in 1990.” (Ex. A, MDL 

Rep. at 13.) Dr. Betensky’s failure to include this decade-long span of adverse event and 

sales data for the SNF is fatal to her analysis because she has no idea how many adverse 

events were reported for the SNF in the ten years she missed. Recognizing the 

significance of the data she failed to consider, Dr. Betensky further admitted, as she must, 

that “if I had had the data for the first ten years, I would have used it.” (Ex. C, MDL 

Dep. Tr., 189:21-22.) 

Dr. Betensky admitted that it is entirely possible she would not have estimated any 

increased risk of adverse events for the removable filters had she considered all of this 

SNF data, as she had done for each of the retrievable filters. Her testimony bears 

repeating here: 

1

 Plaintiffs filed a separate Omnibus Statement Of Law And Generally-Applicable 

Arguments In Opposition To Bard’s Motions To Exclude Plaintiffs’ Experts Under Rule 

702 And Daubert (Doc. 7799). Plaintiffs’ Omnibus Statement is not directed at any 

specific Daubert motion Bard filed. As such, Bard does not respond to the Omnibus 

Statement but instead will address any necessary issues in the context of its individual 

Daubert replies. 

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Q. Because you didn’t have data for adverse events for 

SNF prior to 2000 and you didn’t have sales data for 

SNF prior to 2000, there’s no way for you, as you sit 

here today, to say that if you had that data and 

calculated reporting risk ratios perhaps the reporting 

risk ratios would be greater for SNF over removable, 

maybe they’d be lower. You just don’t know one way 

or another, right? 

A. I don’t have the data so I don’t know what the number 

would be if I had had the data. It could go -- like you 

said, I could get -- I could have gotten RRs that are 

larger than what I got. I could have gotten RRs that are 

smaller than what I got. 

(Id. at 122:1-13.)2

It goes without saying that Plaintiffs’ counsel cannot testify, and their interpretation 

of data Dr. Betensky failed to consider in no way salvages her report. It is equally the 

case that Dr. Eisenberg, who is not offered as a biostatistician in this case, cannot remedy 

Dr. Betensky’s failure to consider this critical data.3 The Court’s inquiry is limited to 

what Dr. Betensky did, and did not, do. 

/// 

/// 

2

 Plaintiffs attempt to limit the relevant pre-2000 SNF data solely to events that post-date 

April 28, 1995, the date FDA cleared the “1995 version of the SNF,” because this version 

“was the predicate to the Recovery filter, so the Recovery and each subsequent filter was 

based on the [1995] SNF.” (Pls. Br. at 3, 13 n.16.) They argue that data “prior to this date 

are not relevant to the comparison.” (Id. at 13 n.16.) Plaintiffs’ argument is invalid for 

two reasons. First, the 1995 SNF is the same device as the pre-1995 SNF. Second, 

Plaintiffs’ argument is completely contrary to the position that they have taken throughout 

this litigation. Plaintiffs now seek to sever the predicate chain starting at the 1995 version 

of the SNF, but continue that chain forward linking each subsequent filter back to that 

1995 SNF. If, as Plaintiffs argue, the 1995 SNF data is relevant to a comparison of 

Denali® data because, down the predicate chain, the Recovery® was based off the SNF 

(Denali® is based off the Eclipse®, which is based off the G2®X, which is based off the 

G2® Express, which is based off the G2®, which is based off the Recovery®, which is 

based off the 1995 SNF), then, by their own logic, the pre-1995 SNF data should be 

equally relevant, because the 1995 SNF is based off of that pre-1995 predicate SNF. 

Plaintiffs’ self-serving severance in this one instance is inconsistent with the position they 

have taken throughout this litigation, and is without merit. 

3

 Furthermore, as Dr. Eisenberg’s new opinions were not set forth in his Rule 26(a)(2)(B) 

expert reports, and as Bard did not elicit these new opinions at deposition, (see Ex. C, 

MDL Dep. Tr., 116:1-13), he should not be permitted to testify regarding this belated 

review. (See Case Management Order No. 8, § I.6 (Doc. 519).) 

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A. The Record Flatly Disproves Plaintiffs’ False Accusations Of Discovery 

Abuse. 

Unable to contest the merits of Bard’s argument, Plaintiffs falsely accuse Bard of 

discovery abuse. Specifically, Plaintiffs argue that Dr. Betensky was “prevented from 

considering” pre-2000 SNF data “because Bard refused to produce it.” (Pls. Br. at 13, 

14.) Plaintiffs’ accusation is devoid of any support. They point to no letter, email, phone 

call, or conversation to corroborate their baseless claim. Nor could they, because this 

accusation is simply untrue. 

Bard produced no less than twenty-four native, Excel spreadsheets containing pre2000 SNF data.4

 All of these spreadsheets were produced in or before October 2016, four 

to five months before Dr. Betensky submitted her expert report. (See Ex. A, MDL Rep.) 

More importantly, most of these spreadsheets were produced to Plaintiffs in early 2013, 

years before the MDL was formed.5 This data was available to Plaintiffs and thus equally 

available for Dr. Betensky’s analysis. Indeed, Plaintiffs ultimately contradict themselves, 

admitting as they must that they “have access to some of these data.” (Pls. Br. at 13.) 

Significantly, Plaintiffs admit that the pre-2000 SNF data was contained in one of the 

spreadsheets that “Dr. Betensky relied on . . . in forming her opinions.” (Id. at 15 (citing 

BPVE-01-01054793).) 

Plaintiffs next accuse Bard of somehow “hiding” this data in the Excel 

4

 The spreadsheets were produced at the following Bates numbers: BPVE-01-01054793; 

BPVE-01-01073574; BPVE-01-01074470; BPVE-01-01074662; BPVE-01-10175227; 

BPVE-01-01075796; BPVE-01-01076261; BPVE-01-01496039; BPVEFILTER-01-

00041441; BPVEFILTER-01-00050487; BPVEFILTER-01-00173992; BPVEFILTER01-00174350; BPVEFILTER-01-00174368; BPVEFILTER-01-00202705; 

BPVEFILTER-30-00363193; BPVEFILTER-30-00363196; BPVEFILTER-30-00363201; 

BPVEFILTER-32-00000003; BPVEFILTER-32-00000009; BPVEFILTER-35-00084821; 

BPVEFILTER-35-00084822; BPVEFILTER-35-00084823; BPVEFILTER-35-00084824; 

and BPVEFILTER-35-00084825. (See Assorted Transmittal Letters, attached hereto as 

Exhibit J.) 

5

 The spreadsheets produced in 2013 include: BPVE-01-01054793; BPVE-01-01073574; 

BPVE-01-01074470; BPVE-01-01074662; BPVE-01-10175227; BPVE-01-01075796; 

BPVE-01-01076261; BPVE-01-01496039; BPVEFILTER-01-00041441; BPVEFILTER01-00050487; BPVEFILTER-01-00173992; BPVEFILTER-01-00174350; 

BPVEFILTER-01-00174368; and BPVEFILTER-01-00202705. (See id.) 

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spreadsheets. (See id. (“Dr. Betensky relied on this spreadsheet in forming her opinions 

(Ex. 1, at 1), but the SNF data before 2000 was hidden in the electronic file by Bard and 

only recently discovered.”).) First, Plaintiffs never claimed anything was wrong with 

these documents throughout the discovery process. They never subsequently indicated 

that anything was “hidden.” (Id.) Plaintiffs claim to have “only recently discovered” 

allegedly “hidden” data after Bard moved to exclude Dr. Betensky. (Id.) Plaintiffs have 

had most of this data for over four years, including BPVE-01-01054793 identified above, 

which Bard produced on April 16, 2013. (See Ex. J.) Yet Plaintiffs did not advise Bard of 

any alleged discovery issue until filing their response brief. 

Bard did not “hide” this data as Plaintiffs falsely claim. Bard produced these 

spreadsheets in their native format as required under Case Management Order No. 9, 

§II.B. (Doc. 1259). Certain of these spreadsheets, as they are kept by Bard in ordinary 

course of business, include data that is “filtered.” This allows a user of the document to 

conduct comparison or analyses of subsets of the data in the spreadsheet. For example, 

the spreadsheet that Bard produced at BPVE-01-01054793 has a date restriction that 

filters out pre-2000 SNF data. However, anyone viewing the native spreadsheet can 

easily see, by looking at the numbered rows, that the non-filtered data starts at row 1695, 

effectively skipping rows 2 through 1694. Anyone familiar with Excel can easily remove 

the filters to view all of the data in the spreadsheet, including the pre-2000 SNF data.6

Finally, as demonstrated above, this was not the only spreadsheet with pre-2000 

SNF data that was available to Dr. Betensky. Plaintiffs had twenty-three other 

spreadsheets available for her use, including four spreadsheets that did not have the pre2000 SNF data filtered out.7

 Plaintiffs have had these four spreadsheets since 2013. (See

6

 To remove Excel filters and view all of the data at once, one need only select the “Sort & 

Filter” drop-down menu on the “Home” ribbon, then select “Clear.” If the rows and 

columns are frozen, select the “View” ribbon, then select the “Freeze Panes” drop-down 

menu, and lastly select “Unfreeze Panes” (or “Freeze Top Row” to keep the top row 

visible while scrolling through the rest of the worksheet). 

7

 The spreadsheets containing unfiltered SNF data were produced at the following Bates 

numbers: BPVE-01-01075796; BPVE-01-01076261; BPVE-01-01496039; and 

BPVEFILTER-01-00202705. (See Ex. J.) 

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Ex. J.) Therefore, Plaintiffs’ accusations of discovery abuse are false, misleading, and 

only highlight the unreliability of Dr. Betensky’s opinions.8

B. Bard’s Internal Use Of Adverse Event Data Has No Bearing On the 

Admissibility Of Dr. Betensky’s Opinions. 

Plaintiffs argue that Dr. Betensky’s opinions are somehow admissible because 

Bard and its consultant, Dr. Lehmann, allegedly conducted certain internal analyses of 

their own using adverse event data. (See Pls. Br. at 13.). Plaintiffs further argue that in 

claiming privilege over Dr. Lehmann’s analysis, Bard represented that Plaintiffs’ experts 

could attempt to replicate it using the same data. (Id.) Yet Bard never represented or 

conceded that any attempt to replicate such an analysis would survive a Daubert 

challenge. Aside from the fact that Plaintiffs have made no showing that Dr. Betensky 

and Dr. Lehmann conducted identical analyses, the purposes are entirely different. 

Plaintiffs would offer Dr. Betensky to opine to the jury that there is a higher risk of 

adverse events for the various retrievable filters over the SNF. As set forth above, her 

opinions are fatally flawed and a gross extrapolation from calculations she admitted were 

“crude.” (Ex. B, Austin Dep. Tr., at 106:20-25.). Dr. Lehmann’s analysis, however, was 

for internal use only and never intended for use in court. As such, it is not subject to 

Daubert and Rule 702. 

Plaintiffs have cited no authority supporting their claim that Bard’s internal 

analysis of adverse events somehow renders Dr. Betensky’s opinions reliable under 

Daubert. (See Pls. Br. at 5-7, 13-14.) Plaintiffs’ sole citation to In re Gadolinium-Based 

Contrast Agents Products Liability Litigation, No. 1:08 GD 50000, 2010 WL 1796334, at 

**2, 6 (N.D. Ohio May 4, 2010), is inapposite. The court in that case found the plaintiffs’ 

expert testimony reliable because, among other reasons, the testimony related “to matters 

8

 Plaintiffs attempt to further divert attention by discussing components of Dr. Betensky’s 

report that Bard did not focus on. (See Pls. Br. at 2 n.1, 11.) Bard does not concede the 

reliability of those opinions. As Plaintiffs acknowledged, these opinions cannot be 

divorced from consideration of her RRR calculations. (Id. at 4, 11 (“cannot be taken in 

isolation” or “considered separately.”) To the extent the Court determines her primary 

opinion on RRR is unreliable, her other opinions must be excluded as well. 

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growing naturally out of research they [the experts] have conducted independent of this 

litigation.” Id. at *6 (emphasis added) (citing Fed. R. Evid. 702 Advisory Committee 

Notes (2000 Amends.)). This case in no way stands for the proposition that a party’s

analysis of data independent of litigation bolsters the reliability of an opposing expert’s 

opinion that purports to replicate that analysis. Dr. Betensky’s opinions do not grow 

naturally out of research she herself has conducted independent of this litigation. Id.

Instead, her analysis was performed solely for this litigation. 

Furthermore, while Plaintiffs make much of the fact that, in addition to Bard, FDA, 

and authors in the medical literature utilize adverse event data, what they omit is 

determinative. As set forth in Bard’s Motion, the FDA guidance is replete with cautions 

against the very use Plaintiffs advocate in this case. (See Mot. at 12-15; Ex. H, FDA 

Guidance at § IV(G).) Indeed, Dr. Thisted testified that, even though the guidance 

provides that comparison of adverse event reports “can be helpful in identifying possible 

trends, [] that same document goes on to describe the limitations of such things. It says, in 

particular, that because reporting to change over time because there can be differences in 

reporting rates for different drugs or different products, that they can’t be relied upon for 

making causal comparisons between two products.” (See Thisted Dep. Tr., 167:15-24, 

July 28, 2017, (“Thisted Dep. Tr.”) attached as Exhibit K; see generally Ex. F, Thisted

Rep.) 

Finally, Bard was clear in its Motion that Dr. Betensky relied on reports “either 

made directly to Bard or that Bard retrieved from the FDA’s [MAUDE] database.” (Mot. 

at 4, 12.) FDA warns “MAUDE data is not intended to be used . . . to compare adverse 

event occurrence rates across devices.” (Ex. D (emphasis added).) That is precisely 

how Dr. Betensky uses the data here. That companies conduct pharmacovigilance and 

analyze adverse event reports for certain internal purposes, which are not subject to 

Daubert or Rule 702, says nothing of the reliability of an expert witness’s comparison of 

these data across devices for publication to a jury in federal court. FDA Guidance 

demands that such improper comparisons be “viewed with extreme caution.” (Ex. H, 

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FDA Guidance at § IV(G).) 

II. Plaintiffs Do Not Contest That Dr. Betensky Did Nothing To Rule Out 

Plausible Alternative Explanations For Her Calculations. 

Dr. Betensky’s opinions are unreliable, notwithstanding her failure to consider 

critical data, because they are based on unsubstantiated assumptions about the reporting 

and detection of adverse events with IVC filters that are supported only by her 

impermissible ipse dixit. Bard explained in its Motion how comparison of SNF data to 

retrievable filters is an apples-to-oranges comparison. (See Mot. at 6.) Specifically, Bard 

detailed the significant differences between the permanent SNF and retrievable filters that 

Dr. Betensky compared, and how these differences can affect the way adverse events with 

these devices are detected and reported. (Id. at 2-4.) Plaintiffs do not address and 

therefore concede the existence and impact of these differences. 

For example, Plaintiffs do not dispute that filter-related adverse events are often 

asymptomatic. Nor do they dispute that these asymptomatic events may be detected with 

greater frequency in patients with retrievable filters over similar patients with permanent 

filters owing to the differences in the design and use of these devices. (See id. at 2-3.) 

Plaintiffs similarly do not contest that there are potential differences in how frequently 

patients with permanent versus retrievable filters are followed, which may also lead to 

increased detection of these asymptomatic adverse events in patients with retrievable 

filters. (See id.) Further, Plaintiffs do not dispute that the dwell time of a filter in a given 

patient may also vary significantly between permanent and retrievable filters, which may 

result in increased detection of these asymptomatic adverse events in patients with 

retrievable filters. (See id.) Finally, Plaintiffs do not dispute that there may be differences 

in the reporting of adverse events, once detected, between retrievable filters and 

permanent filters, due to the publicity surrounding and related to ongoing litigation over 

retrievable filters. (See id. at 3-4, 12.) Nor do they contest that this may result in 

increased reporting of adverse events in patients with retrievable filters over similar 

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patients with permanent filters.9

Dr. Betensky admitted that she did nothing to account for these differences. (See 

Ex. C, MDL Dep. Tr., 185:7-14 (“Q. What, if anything, did you do in this case to control 

for the possibility that individuals with asymptomatic adverse events that have retrievable 

filters only had those symptoms detected when the filter was removed? . . . A. I didn’t 

have any information to do anything about that.”); 189:7-10 (“A. I, I didn’t take into 

account potential changes in reporting. Q. Based on litigation? A. Based on 

litigation.”); 191:1-10 (“Q. It’s entirely possible that the increases over time in reporting 

for the removable products that you noted were related to high profile litigation connected 

with the products, right? That’s possible? . . . A. Anything is possible. I suppose. Q. 

You didn’t do anything to rule out that possibility, did you? A. I don’t have -- I didn’t 

have the data to be able to do that kind of level of analysis.”).)10

Furthermore, before she could draw unbiased inferences regarding an increased RR 

from her calculated RRRs, Dr. Betensky was “required” to apply certain “plausible” 

assumptions about the differential detection and reporting of adverse events between the 

retrievable filters and the SNF. (See Ex. E, Rebuttal Rep. at 1; Ex. C, MDL Dep. Tr., 

96:9-11 (“in order to . . . draw inferences about the risk ratio from the reporting risk ratio, 

that’s where assumptions are required.”).) Otherwise, her opinions would be biased 

because the elevated risk she calculated could be due to the differences identified above, 

instead of, and entirely unrelated to, any actual increased risk. If her assumptions are 

9

 Bard also identified the diminished likelihood that adverse events in patients with the 

permanent SNF would be reported over similar patients with retrievable filters based on 

the “Weber Effect,” because the SNF had been on the market for over a decade before the 

retrievable filters. (See Mot. at 3-4.) Plaintiffs’ own expert recognizes that the “Weber 

Effect” may impact her analysis, (see Ex. A, MDL Rep., at 13; Ex. B, Austin Dep. Tr., 

110:11-14), undermining Plaintiffs’ contrary argument. (See Pls. Br. at 14.) 

10 Although Plaintiffs broadly assert that Dr. Betensky identified and considered these 

limitations when interpreting her results, (see Pls. Br. at 3, 5-6), they do not contradict her 

clear testimony that she did nothing to account for these differences. Plaintiffs provide no 

authority to support their claim that the reliability of Dr. Betensky’s opinion is 

strengthened by her recognition of these limitations. (Id. at 6 (emphasis added).) Instead, 

her failure to rule out these plausible alternatives is further evidence of the unreliability of 

her opinions. 

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wrong, Dr. Betensky concedes “it wouldn’t be appropriate to consider the reporting risk 

ratio as a risk ratio.” (Ex. C, MDL Dep. Tr., 177:11-12.) As Bard explained in its 

Motion, to substantiate these assumptions requires an expert understanding of these 

complex medical devices and their use by the medical community. (See Mot. at 7.) Dr. 

Betensky admitted she lacks this specific expertise. (See id. at 7-10.) 

Plaintiffs do not contradict this testimony, nor do they dispute that she failed to 

collaborate with anyone with such expertise. Instead, Plaintiffs claim that her expertise as 

a biostatistician somehow qualifies her to understand the differential detection and 

reporting of adverse events in these complex devices. (See Pls. Br. at 6 n.8.) This claim 

is without merit and is belied by Dr. Betensky’s own testimony: 

Q. You’re not a medical expert when it comes to what might impact the 

differential discovery and reporting of adverse events in a removable 

filter versus adverse events in a permanent filter? 

A. I’m not a medical expert in that. 

(Ex. C, MDL Dep. Tr., 187:23 to 188:2.) 

Q. You’re not an expert in the manner in which potential filter adverse 

events are detected, are you? 

A. Not in how they are clinically detected. 

(Id. at 92:8-10.) 

Q. You’re not an expert in the differences in how adverse events are 

clinically detected in retrievable filters versus permanent filters, 

right? 

A. Correct. 

(Id. at 92:12-15.)11

Without an expert understanding of these differences to substantiate Dr. Betensky’s 

assumptions, they are based on nothing more than her own ipse dixit. This is significant 

because, as Bard explained, and as Plaintiffs do not dispute, these assumptions are 

necessary to bridge the analytical gap between the RRR that Dr. Betensky calculated “and 

11 Contrary to Plaintiffs’ assertion, (see Pls. Br. at 6 n.8.), none of the experts that relied 

on Dr. Betensky’s report specifically accounted for these differences. (Cf. Pls. Ex. 13, ¶ 

314; Ex. 14, ¶ 111; Ex. ¶ 33.) 

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the actual risks,” RR, that she estimated. (Ex. B, Austin Dep. Tr., 134:25 to 135:14.)12

“[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to 

admit opinion evidence that is connected to existing data only by the ipse dixit of the 

expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Dr. Betensky’s opinions of 

increased risk, RR, are connected to her calculated RRR only by her ipse dixit. Thus, this 

Court should “conclude that there is simply too great an analytical gap between the data 

and the opinion proffered,” and exclude her opinions. Id. 

CONCLUSION 

For each of these reasons, Bard respectfully requests that this Court exclude the 

opinions of Dr. Betensky in their entirety. 

RESPECTFULLY SUBMITTED this 18th 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.

12 Plaintiffs similarly do not dispute that Dr. Betensky’s RR is just a guess, a “crude 

estimate” of risk. (Ex. B, Austin Dep. Tr., at 106:20-25.) They do not dispute that she did 

not calculate an actual, quantifiable, increased risk or numerical value for RR. (See Mot. 

at 14-15.) She just inferred an increase without any real confirmation. Nor do Plaintiffs 

dispute that she has no rate of error and cannot calculate one. (Id. at 15.) 

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CERTIFICATE OF SERVICE 

I hereby certify that on this 18th day of October 2017, the foregoing was 

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

automatically send e-mail notification of such filing to all attorneys of record. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

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