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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, Arizona 85004-2202 

Telephone: 602.382.6000 

Facsimile: 602.382.6070 

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 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

Telephone: (404) 322-6000 

Telephone: (404) 322-6050 

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 BRIEF 

IN SUPPORT OF ITS MOTION TO 

EXCLUDE OPINIONS OF ROBERT 

M. McMEEKING, PH.D. 

(ASSIGNED TO THE HONORABLE 

DAVID G. CAMPBELL) 

(Oral Argument Requested) 

INTRODUCTION 

Dr. McMeeking has failed to provide reliable opinions that will assist the trier-offact in this case with respect to four areas of his opinions. Therefore, Bard respectfully 

requests that the opinions identified below be excluded in this case. 

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A. Dr. McMeeking’s Opinion That Bard Did Not Go Far Enough to 

Reduce the Risks With its IVC Filters Is Not Based on an Appropriate 

Engineering Methodology and Is Therefore Unreliable. 

Plaintiffs seek to have Dr. McMeeking opine first, that Bard retrievable filters are 

defective in various ways, and second, that Bard failed to practicably reduce risks in its 

filters. (Ex. A, McMeeking Dep. Tr., 23:9-18, July 6, 2017.) It is the second opinion that 

Bard seeks to exclude. Under a Daubert analysis, an expert must demonstrate that he has 

used scientific methodology appropriate in his area of expertise to support each opinion he 

seeks to provide. Salinas v. Amteck of Ky., Inc., 682 F. Supp. 2d 1022, 1030 (N.D. Cal. 

2010). Here, Dr. McMeeking has not done so. Dr. McMeeking presented certain work in 

this case through finite element analysis and calculations that he claims support his 

conclusions (i.e., that Bard retrievable filters have design defects and Bard could have 

altered the design of the devices to eliminate those alleged defects). That work, however, 

is not sufficient to support his opinion that Bard could have practicably reduced the risks 

in its filters yet failed to do so. In particular, he has failed to employ any methodology in 

determining, or make a detailed analysis of, the alternative design features he advocates. 

For example, he has made no analysis to show (1) that changes in the product that he 

claims could have been made would have reduced risks, (2) which risks such changes 

would have reduced, (3) the extent to which such changes would have reduced those risks, 

(4) whether such changes would have negatively impacted the retrievability of the filters, 

and (5) whether such changes would have otherwise caused unintended patient 

consequences. 1 Dr. McMeeking failed to conduct any engineering analysis beyond 

offering mere observations about what Bard could have done to modify its filters and 

made no effort to assess what outcomes those changes would have had with respect to the 

reduction of risks. 

1Bard will show, through its engineering expert, other witnesses, and evidence that Dr. 

McMeeking’s analysis of Bard’s design and the conclusions he draws relative to 

purported design defects in Bard filters is a flawed and inaccurate analysis which does not 

support the conclusions Dr. McMeeking draws. Bard does not seek to exclude this portion 

of Dr. McMeeking’s opinions. 

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Dr. McMeeking’s testimony makes clear that he has not performed the type of 

engineering analysis that could establish the reliability of this opinion. Instead of 

providing an engineering assessment of whether Bard could make changes to the product 

that would have reduced risks (while still maintaining the critical characteristic of 

retrievability), or providing an assessment of the extent to which Bard’s modifications did 

reduce risks, Dr. McMeeking simply concludes summarily that Bard has failed to 

practicably reduce risks. In some instances, he dismisses Bard’s filter modifications as 

having no effect on risks, while agreeing that he has done no analysis directly comparing 

the characteristics of the modified Bard filters to prior models. In other instances, he 

simply declines to provide any opinion as to whether those modifications in fact reduced 

risks in these filters, and if so, to what extent they did so, and as to which risks. 

Dr. McMeeking’s deposition is replete with testimony demonstrating that he has 

neither conducted an analysis nor employed any methodology to arrive at his conclusory 

opinion that Bard could have created alternative filter designs to reduce the risks 

associated with the devices: 

Q Okay. Is it your opinion that the various modifications that Bard 

has made along the way to its retrievable IVC filters did nothing to 

reduce the risks associated with either tilt, perforation, migration or 

fracture? 

THE WITNESS: The -- some of the changes that were made would 

have some effects on one or more of those phenomena that can take 

place in filters, and in some cases it’s unclear whether the measure 

taken had the effect intended, but -- but there would have been some 

benefits from some of the changes which were made. 

(Ex. A, McMeeking Dep. Tr., p. 25:11-23.) 

Q And you have not done work that would tell you what the specific 

modifications of filters that Bard has -- has included would do with 

respect to, for example, loads on the filter, strains that the filter is – 

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A I have not -- 

Q -- strains that the filter sees or loads that are put on those filters? 

THE WITNESS: I have not done any calculations that specifically 

identify the detailed differences that would occur because of the 

design changes going from the G2X through to the Denali. 

(Id. at 27:11 – 16; 27:24 – 28: 6.) 

Q The other thing you talked about was that Bard could have 

redesigned the configuration of its filters. It was a little vague to me. 

What do you mean by that? 

A Well, I mean the -- the shape of the limbs, the dimension of the 

limbs, in other words their -- their diameter, they could have 

considered different numbers of limbs, they could even have 

considered moving to a different material. So there’s a fairly large 

number of design choices that could have been considered, and they 

could well have come up with a combination of features in the 

design that gave them a better combination of -- of phenomena in 

terms of how the filter behaved. 

(Id. at 34:9 – 23.) 

Q Have you done any work to determine what modifications Bard 

could have made to the legs themselves to improve on those legs' 

contribution, if any, to tilt, perforation, fracture or migration? 

A No, I haven't looked into that. 

Q We’ve talked a little bit about the anchors and limiters present on 

the Meridian. Is it your opinion that those are reasonable 

modifications by Bard to -- to improve resistance to migration, tilt 

and perforation? 

A It’s a reasonable concept for how the tilt and migration behavior 

can become -- can be limited. 

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Q Would -- do you have an opinion whether those anchors or 

limiters on the Meridian would add fracture resistance to that filter? 

A I have no opinion on that. 

Q Same questions with Denali, do you think that the limiters that the 

Denali has will act to improve resistance to migration, tilt, 

perforation and fracture? 

THE WITNESS: It’s -- it is reasonable to expect that there will be 

some effect on -- on tilt and migration and that those would have 

possible knock-on consequences to perforation and fracture. And so 

I’d like to revise my answer about the Meridian in the same way, 

that the caudal anchors, to the extent they limit tilt and migration, 

they could have beneficial effects on perforation and fracture. 

(Id. at 129:13 – 130:19.) 

Q Do you have an opinion about whether any design modification 

that Bard made to the G2 filter resulted in caudal migration? 

A I have no opinion on that because I have not studied it. 

Q Okay. And have you done any work to determine how Bard might 

have modified its filters to reduce tilt that you associate with caudal 

migration, with contributing to caudal migration? 

THE WITNESS: Well, the only observation I have is that the 

effective caudal anchors would have had a beneficial effect, but 

otherwise I’ve done no thinking or studying of that. 

(Id. at 131:16 -18, 132:1 - 2; 132:18 – 133:1.) 

Q Do you know of modifications to the Bard filters, any of them, 

that would have made them unable to fracture, tilt, perforate or 

migrate? 

THE WITNESS: I haven’t studied that. 

(Id. at 149:18 – 21, 150:9.) 

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Q Having looked at the Denali filter, you do see that there are some 

differences in that filter than the previous ones, true? 

A Yes, that’s correct. 

Q Okay. Is it your opinion that Bard has failed to reduce as far as 

reasonably practicable by taking adequate protection measures risks 

of tilt, perforation, fracture and migration in the Denali? 

A Yes. 

Q And what’s the basis for that? 

A Because you still see incidences of all of those phenomena in 

Denali filters. 

(Id. at 45:5 – 25.) 

In short, Dr. McMeeking used no methodology and made no analysis in this 

litigation sufficient to opine that Bard failed to practicably reduce risks in its filters. See 

Salinas, 682 F. Supp. 2d at 1030. Therefore, Bard respectfully requests that his opinions 

in that regard be excluded here. 

B. Dr. McMeeking’s Opinion That Bard’s Communications With the FDA 

Failed to Fully Communicate Relevant Information Regarding its IVC 

Filters Is Unreliable. 

Dr. McMeeking has not been offered as an FDA regulatory expert in this litigation. 

While Plaintiffs state that Dr. McMeeking has appeared before the FDA previously, in 

some capacity (Pls. Resp. Br. (Doc. 7806), at 12, n. 9), Dr. McMeeking has not provided 

any regulatory analysis in this case, nor has he shown that he has the qualifications to 

interpret the appropriateness of Bard communications with the FDA or Bard’s intent in 

providing those communications. In fact, he has testified that he relies on Dr. Parisian to 

provide such opinions in this litigation. (Ex. A, McMeeking Dep. Tr., 51:24 – 52:14, 

July 6, 2017.) In similar circumstances, courts have limited the scope of an expert’s 

opinions where they venture into areas outside of their qualifications. See e.g. Morritt v. 

Stryker Corp., 973 F. Supp. 2d 177, 188 (E.D.N.Y. 2013) (finding that a physician who 

had significant clinical experience with the medical device at issue went “well beyond the 

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‘reasonable confines’ of his clinical expertise” when offering opinions regarding 

biomedical engineering and material science); In re: Breast Implant Litig., 11 F. Supp. 2d 

1217, 1243-44 (D. Colo. 1998) (excluding design opinions of a scientist who held a Ph.D. 

in physical chemistry because being a chemist did not automatically qualify the witness 

on design issues when he lacked training and experience concerning design of breast 

implants). 

While Dr. McMeeking has engineering expertise that may qualify him to provide 

opinions that certain Bard communications with the FDA contained technical 

inaccuracies, he cannot provide a reliable opinion in this case that Bard communications 

with the FDA were “misrepresentations” or a failure to be “frank and honest.” Nor is he 

qualified to opine that Bard failed to inform the FDA appropriately regarding 

complications with its products. Those opinions, alone or as a whole, are not within the 

scope of Dr. McMeeking’s expertise, and should be excluded as unreliable. See e.g., 

Morritt, 973 F. Supp. 2d at 188; Kruger v. Johnson & Johnson Professional, Inc., 160 F. 

Supp. 2d 1026, 1031 (S.D. Iowa 2001) (finding that a metallurgist was unqualified to offer 

design opinions regarding bone screws where he had no experience in the design of 

medical implants or any other medical devices); In re: Breast Implant Litig., 11 F. Supp. 

2d at 1243-44.

Furthermore, Dr. McMeeking does not provide an engineering methodology for 

how he ascertained that Bard’s communications with the FDA were “misrepresentations,” 

were not “frank and honest,” or failed to provide the FDA with complication information. 

Rather, he relies on Dr. Parisian to support his opinions on the sufficiency and intent of 

Bard’s communications with the FDA. (Ex. A, McMeeking Dep. Tr., 51:24 – 52:14, 

July 6, 2017.) In their Omnibus brief2 (Pls. Omnibus Br. (Doc. 7799), at 7), Plaintiffs 

2

 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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concede it is impermissible for an expert to “merely act as a conduit for the other expert’s 

opinion.” In re Toyota Motor Corp. Unintended Acceleration Mktg. Sales Practices, and 

Prods. Liab. Litig., 978 F. Supp. 2d 1053, 1066 (C.D. Cal. 2013) (emphasis added). As 

Plaintiffs further concede, the law requires the record to show that “the expert 

independently evaluated the evidence supporting the other expert’s opinion.” Id. In other 

words, there is no dispute that one expert cannot simply regurgitate the opinions of 

another and claim they support his own opinion, as Dr. McMeeking purports to do in this 

case. 

Dr. McMeeking did not independently verify Dr. Parisian’s work, did not analyze 

all of her source documents, and did not verify her methodologies. Instead, he simply 

assumed that her opinions are based on reliable methodologies and reliable underlying 

data. (Ex. A, McMeeking Dep. Tr., 51:24 – 52:14, July 6, 2017.) Because Dr. McMeeking 

uses Dr. Parisian’s findings as a basis for his own opinion about the quality of Bard’s 

FDA communications, without any independent verification of Dr. Parisian’s work, Dr. 

McMeeking’s opinion is unreliable, and should be excluded in this case. 

C. Dr. McMeeking’s Opinions on Filter Complication Rates Are Also 

Unreliable. 

In his MDL deposition, Dr. McMeeking testified that he would not give opinions 

on filter complication rates in these cases (Id. at 175:14-176:1) and that he would not be 

giving opinions interpreting medical literature and incidence of complications. Despite 

that disclaimer, however, he insisted on opining that the medical literature reports of 

complications “tend to confirm that the filters are . . . dangerous.” (Id. at 176:2-11.) 

Having agreed that he will not give opinions on rates, having performed no rate analysis 

of any kind, and having agreed that he has not interpreted medical literature, Dr. 

McMeeking has not provided the necessary methodology to allow him to give a reliable 

opinion that complications reported for Bard filters show that they are “dangerous.” He 

should therefore be precluded from giving such an opinion in this case. 

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In a related fashion, Dr. McMeeking also opines that the rates of complications in 

Bard retrievable filters, versus those in the Simon Nitinol Filter (“SNF”), support his 

conclusion that Bard filters are prone to complication. For that opinion, he again relies on 

the analysis of another one of the Plaintiffs’ experts, this time Dr. Betensky. (Pls. Resp. 

Br., at 13:19-14:2.) As noted above, Plaintiffs concede that it is impermissible for an 

expert to “merely act as a conduit for the other expert’s opinion” and that the law requires 

the record to show that “the expert independently evaluated the evidence supporting the 

other expert’s opinion.” (Pls. Omnibus Br., at 7.) Here, however, Dr. McMeeking admits 

he did not review any of the underlying adverse event data, let alone the Excel 

spreadsheets on which Dr. Betensky relied (“No, I did not look at her Excel sheets.”). (Ex. 

A, McMeeking Dep. Tr., 186:4-12, July 6, 2017.) In fact, Dr. McMeeking did nothing to 

verify the reliability of Dr. Betensky’s work (“Q. And you did not independently verify 

her work? A. No.”). (Id. at 187:16-18.) Had he done so, Dr. McMeeking presumably 

would not have misrepresented Dr. Betensky’s opinions as he has. Contrary to Dr. 

McMeeking’s representations, Dr. Betensky never calculated “higher rates of fracture” for 

Bard retrievable filters over the SNF. (Ex. A to Bard’s Motion to Exclude McMeeking, 

McMeeking 3/3/17 Rule 26 Report, at 25-26). In fact, Dr. Betensky never calculated any 

rates at all (“Q. You did not calculate any rate in connection with your expert opinions in 

this case, right? A. I did not calculate any rate. I calculated what I call risk or 

proportion.”); (“Q. If someone described your report and stated that you had calculated 

any rates, that would not be a careful distinction between risk and rate, right? A. That 

would not be what I had done in my report.”). (Ex. B, Betensky Dep. Tr., 139:24-140:2, 

147:19-23, June 23, 2017.) 

Rather than calculate a rate, as Dr. McMeeking mistakenly claims she did, Dr. 

Betensky instead calculated a “reporting risk ratio,” (“RRR”) which did nothing more 

than compare the proportions of anecdotal adverse event reports for the various retrievable 

filters over sales to the proportions of anecdotal adverse event reports for the SNF over 

SNF sales. Dr. Betensky emphasized that “the qualifier ‘reported’ is important and that’s 

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indicating that the data are coming from reports, and are not being derived from a 

beautifully run and designed experiment like a clinical trial, in which there’s perfect 

follow-up and in which it’s really a true experiment. So the ‘reporting’ qualifier is there to 

say and to suggest that these are numbers that are reported. These are based on reports.” 

(Ex. C, Betensky Dep. Tr., 60:12-20, July 26, 2016.) Because of the inherent limitations in 

the data that she considered, Dr. Betensky described her RRR as a “crude estimate[] of 

risk.” (Id. at 106:20-25.) Indeed, as she acknowledged, Dr. Betensky’s RRR “could be an 

overestimate or it could be an underestimate” of risk. (Id. 62:14-19.) Hence, Dr. 

McMeeking’s interpretation, without independent verification, that Dr. Betensky found 

that Bard retrievable filters have higher complication rates than the SNF is without 

scientific support and is, in fact, contrary to Dr. Betensky’s own admissions. Given that 

Dr. McMeeking’s reliance on Dr. Betensky’s analysis is the basis for his opinion that Bard 

retrievable filter rates are high, or higher than the SNF, that opinion should be excluded in 

this case. 

D. Dr. McMeeking’s Opinion That SNF Is a Safer Alternative Product Is 

Unreliable and Should Be Excluded. 

Dr. McMeeking’s opinion that the SNF is a safer filter than Bard retrievable filters 

is neither reliable nor helpful. First, Plaintiffs and Dr. McMeeking ignore the fact that the 

SNF is a non-retrievable filter, making its function critically different from that of Bard’s 

retrievable filters. While Bard filters were marketed as both permanent and retrievable 

filters, ignoring the retrievable function of these filters when arguing that the SNF is a 

safer alternative product is fatal to the reliability and helpfulness of Dr. McMeeking’s 

opinions on this issue. As a product without the key feature of Bard’s retrievable filters 

(retrievability), the SNF simply cannot be an alternative safer product. See Clinton v. 

Brown & Williamson Holdings, Inc., 498 F. Supp. 2d 639, 645 (S.D.N.Y. 2007) (holding 

that the plaintiff’s proffered alternative design must be the “functional equivalent” of the 

allegedly defective product); Moss, by Gideon v. Wolohan Lumber Co., No. 92 C 7786, 

1995 WL 348144, at *5 (N.D. Ill. June 7, 1995) (holding that proposed alternative design 

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must exhibit same functions as allegedly defective product); Mascarenas v. Cooper Tire 

& Rubber Co., 643 F. Supp. 2d 1363, 1369 (S.D. Ga. 2009) (proposed alternative design 

must be “equally efficacious”); Casey v. Toyota Motor Eng'g & Mfg. N. Am., Inc., 770 

F.3d 322, 331 (5th Cir. 2014) (proposed alternative design must not impair the product’s 

utility). Indeed, while Dr. McMeeking compared certain SNF design documents to 

Recovery design documents, and made some observations and calculations about aspects 

of the SNF’s design (including the SNF filter’s stiffness) (Ex. A, McMeeking Dep. Tr., 

193:6 – 195:22, July 6, 2017), he made no analysis of what changes would have to be 

made to an SNF filter to allow it to be retrieved: 

Q. Did you do any analysis of how one would make changes to either the petal 

dome or the legs of the SNF to allow it to be retrievable? . . . 

A. . . . But to move on to your subsequent question, I didn’t make -- do any 

analysis to look at what changes might . . . impact they would have on the behavior 

of the filter . . . 

Q. How that might have to be re-engineered to allow for retrieval? 

A. I did not look at that. 

(Id. at 205:16 – 17, 205:25 – 206:4, 206:8 – 10.) Therefore, Dr. McMeeking’s opinion on 

this issue should be excluded here. 

Plaintiffs dismiss Bard’s argument that the SNF cannot be a safer alternative 

design, arguing that “Bard chose to rely on the SNF as the predicate device for its 

optionally retrievable filters, which requires those filters to be ‘substantially equivalent’ to 

the SNF. Bard then made the choice to have . . . the Recovery and G2, initially cleared for 

permanent use only – just like the SNF.” (Pls. Resp. Br., at 17:19-18:5). In so arguing, 

Plaintiffs conflate the concepts of “substantial equivalence” under FDA regulations and 

the legal definition of an alternative safer design.3 By doing so, Plaintiffs ignore the fact 

3

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.”); In re Ethicon, Inc., Pelvic 

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that though the Recovery and G2 are retrievable filters that can be placed permanently, the 

SNF is a permanent filter that cannot be retrieved percutaneously. Plaintiffs are essentially 

trying to argue that because the SNF was the predicate device for the Recovery and G2, 

the Recovery and G2 have the same design characteristics as the SNF. But that is false. 

They do not possess all of the same design characteristics. 

The Plaintiffs also argue that the products considered in the safer alternative design 

cases to which Bard cites are distinguishable from Bard’s retrievable filters here because 

those products functioned as intended. (Id. at 14-21). Plaintiffs’ attempt to distinguish the 

Felix4 and McCarthy5 opinions from the instant case is unpersuasive. Both cases6 stand for 

the proposition that “functional differences” between an allegedly defective product and 

the proffered alternative design are fatal to a plaintiff’s case. 7 To avoid this result, 

Plaintiffs advocate for an overly narrow reading of the Felix and McCarthy holdings in an 

effort to limit the opinions’ applicability only to cases where the alleged defect constitutes 

a functional aspect of the product. Plaintiffs’ argument, however, ignores the reality 

exemplified by the case at hand that a product’s allegedly defective design characteristics 

Repair Sys. Prod. Liab. Litig., No. 2:12-CV-4301, 2014 WL 505234, at *9 (S.D.W. Va. 

Feb. 5, 2014) (holding“[w]hile 510(k) approval may mean the ProteGen was 

“substantially similar” to the TVT, it did not mean the products were identical. A new 

device may be ‘substantially equivalent’ even though its technology is very different from 

the predicate device.”); Runnels v. Tahsin Indus. Corp., USA, No. 3:11-CV-106-CWRLRA, 2013 WL 6834632, at *12 (S.D. Miss. Dec. 23, 2013) (“A feasible design 

alternative is a design that would have to a reasonable probability prevented the harm 

without impairing the utility, usefulness, practicality or desirability of the product to users 

or consumers.”). 

4 Felix v. Akzo Nobel Coatings, Inc., 262 A.D.2d 447, 692 N.Y.S.2d 413 (2d Dept. 1999). 

5 McCarthy v. Olin Corp., 119 F.3d 148 (2d Cir. 1997). 

6

 Both Felix and McCarthy interpret the law of New York which has a more developed 

body of law on this issue compared to the relative dearth of case law in the bellwether 

jurisdictions. However, at least one court in the bellwether jurisdiction of Wisconsin has 

considered and ruled on this issue. See Below v. Yokohama Tire Corp., No. 15-CV-529-

WMC, 2017 WL 679153, at *4 (W.D. Wis. Feb. 21, 2017) (concluding that plaintiffs 

offered insufficient evidence that high-speed tire – proposed as an alternative design – 

was sufficiently similar to light truck tire – which was allegedly defective). 

7 See Felix, 262 A.D.2d at 448, 692 N.Y.S.2d 413 (rejecting proposed alternative design 

that was “not essentially the same” as the allegedly defective product because it exhibited 

“functional difference[s]”); McCarthy, 119 F.3d at 155 (rejecting proposed alternative 

design that lacked “functional element” present in allegedly defective product). 

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may be integral to, but not necessarily constitute, the product’s functionality. For example, 

in the case at hand, Plaintiffs have not alleged that retrievable filters are defective simply 

because they are retrievable. Rather, Plaintiffs argue that underlying design characteristics 

integral to the filters’ retrievable function may constitute the alleged product defects. 

Nevertheless, under Felix and McCarthy, the non-retrievable SNF filter lacks the 

retrievable function of the Recovery and G2 filters, and this functional difference is fatal 

to Plaintiffs’ use of the SNF filter as a proposed alternative design. 

Dr. McMeeking’s entire methodology supporting his opinion that the SNF is a 

safer alternative product -- including his calculations -- is based on the false premise that 

the non-retrievable SNF filter is functionally equivalent to the retrievable Recovery and 

G2 filters. However, Dr. McMeeking himself acknowledged the functional differences 

between the permanent SNF filter and the retrievable Recovery and G2 filters.8 Because 

of these admitted functional differences, the permanent SNF filter is not a feasible 

alternative design for Bard’s retrievable filters because it fails to match the additional 

utility of the retrievable filters. Dr. McMeeking’s methodology and conclusions 

attempting to prove otherwise flout both the law and the facts. 

Plaintiffs also argue that “If making Recovery, G2, and later filters retrievable also 

made them less safe in terms of tilt, perforation, migration, and fracture as compared to 

the SNF, then it was not appropriate for Bard to use the SNF as a predicate device.” (Id. at 

15, n. 15). Again, Plaintiffs misconstrue the definition of “substantial equivalence” and 

argue that alleged higher rates of complications in Bard retrievable filters make the SNF a 

safer alternative. The alleged higher rates in Bard retrievable filters compared to the SNF, 

on which Dr. McMeeking relies, come from an analysis by Plaintiffs’ expert Dr. 

Betensky. Giving his interpretation of Dr. Betensky’s analysis, Dr. McMeeking stated:

I also have reviewed an analysis of adverse event reporting for 

the various Bard IVC filters [52]. This analysis was performed 

by . . . Dr. Rebecca Betensky, and was based on Bard’s own 

8

 Ex. B to Bard’s Motion to Exclude McMeeking, McMeeking Dep. Tr., 221:16-223:3, 

July 6, 2017. 

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internal adverse event data. Dr. Betensky’s analysis [52] 

shows statistically significant differences between the 

Recovery and the Simon Nitinol Filter (SNF), the G2 and the 

SNF, the Eclipse and the SNF, the Meridian and the SNF, and 

the Denali and the SNF. Dr. Betensky’s analysis [52] also 

shows that all Bard filters, including the Eclipse, Meridian, 

and Denali, had higher rates of fracture than SNF and that 

those higher rates of facture are statistically significant in 

comparison with SNF fracture rates . . . This adverse event 

analysis carried out by Dr. Betensky [52] is consistent with 

and supportive of my opinions in this report. 

(Ex. A to Bard’s Motion to Exclude McMeeking, McMeeking 3/3/17 Rule 26 Report, at 

25-26.). In short, Dr. McMeeking has made it clear that his methodology regarding the 

comparison to the SNF is blind reliance on the opinions of Dr. Betensky. However, as 

previously noted, Dr. McMeeking’s reliance on Dr. Betensky’s work to support that 

opinion fails to provide the necessary methodology to make that opinion reliable. 

As also discussed in Section C, supra, Dr. McMeeking’s interpretation of the 

Betensky analysis is simply wrong. Rather than calculate a rate, Dr. Betensky calculated a 

“reporting risk ratio,” (“RRR”) which did nothing more than compare the proportions of 

anecdotal adverse event reports for the various retrievable filters over sales to the 

proportions of anecdotal adverse event reports for the SNF over SNF sales. Dr. Betensky 

described her RRR as a “crude estimate[] of risk,” which “could be an overestimate or it 

could be an underestimate” of risk.” (Ex. C, Betensky Dep. Tr., 62:14-19, 106:20-25, July 

26, 2016.) Indeed, in her analysis, Dr. Betensky used data that was particularly flawed. 

Specifically, she used only sales and adverse event information for the SNF from the year 

2000 forward, although she was aware that “the SNF was launched in 1990.” (Ex. C to 

Bard’s Motion to Exclude McMeeking, Betensky 1/27/17 Rule 26 Report, at 13.) She, 

therefore, omitted the first ten years of adverse event reports and sales data from her 

analysis of the SNF. (Ex. B, Betensky Dep. Tr., 125:20-126:2, June 23, 2017.) Because 

Dr. Betensky’s reporting risk ratios might have increased for SNF with another ten years 

of adverse event data, her analysis is flawed. Simply put, Dr. Betensky has not established 

what the comparative rate of failures is through her analysis and Dr. McMeeking has done 

nothing to independently verify Dr. Betensky’s results, let alone somehow transform her 

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analysis into a true analysis of comparative rates. Consequently, Dr. McMeeking, in 

relying on Dr. Betensky’s analysis, has used improper methodology to conclude that SNF 

complication rates are lower than those with Bard retrievable filters -- the critical 

underlying assumption for his opinion that the SNF is a safer filter than Bard retrievable 

filters. 

As demonstrated above, even if the SNF could be compared to Bard retrievable 

filters for relative safety, which Bard shows it cannot be, the Betensky analysis used by 

Dr. McMeeking to reach his conclusion that the SNF is a safer filter is unreliable and 

therefore makes his opinion unreliable (and inadmissible). Therefore, Dr. McMeeking’s 

opinions that the SNF is a safer filter should be excluded in this case. 

CONCLUSION 

Dr. McMeeking’s analyses and methodology are insufficient, and/or rely on 

opinions and analyses of other experts without verifying those opinions. Therefore, the 

opinions discussed in this motion are unreliable and/or will not help the trier-of fact to 

determine the issues presented in this case. As a result, Bard respectfully requests that the 

Court exclude those opinions here. 

DATED 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 

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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 October 18th 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. 

Case 2:15-md-02641-DGC Document 8227 Filed 10/18/17 Page 17 of 17