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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 IN 

SUPPORT OF ITS MOTION TO 

EXCLUDE THE OPINIONS OF 

ROBERT O. RITCHIE, PH.D. 

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested) 

The Plaintiffs’ Response1 highlights Dr. Ritchie’s professional history and argues 

that his background as an engineer qualifies him to testify about filter complication failure 

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 

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rates, the adequacy of Bard’s filter testing, his “vicious circle” theory, and that the Simon 

Nitinol Filter (“SNF”) is a safer alternative design. These opinions, however, are not 

based on any scientific methodology, and they rely upon the work of other experts without 

any independent verification, thus, they are unreliable, will not assist the trier-of-fact, and 

should be excluded. 

A. Dr. Ritchie Is Not Qualified To Comment on or Refer in Any Way to 

Failure Rates or Relative Rates of Complications. 

Dr. Ritchie intends to provide opinions in this litigation that Bard retrievable filters 

have high and unacceptable complication rates. (Ex. B to Mot., Ritchie 3/2/17 Rule 26 

Report, at 2, 45, 105); (Ex. C to Mot., Ritchie 5/12/17 Rule 26 Rebuttal Report, at 5); Ex. 

A to Mot., Ritchie Dep. Tr., 133:18-25, June 9, 2017.) Plaintiffs argue that Dr. Ritchie 

may opine on the issue of rates, as a materials engineer, because he relies on published 

literature and the “relative risks” calculated by Plaintiffs’ expert, Dr. Betensky. (Pls. Br. 

(Doc. 7807), at 3:23-26.) Plaintiffs do not suggest that Dr. Ritchie is a medical doctor, 

statistician, or an epidemiologist experienced in interpreting medical data and medical 

literature. Dr. Ritchie himself admits he does not have those qualifications. (Ex. A to 

Mot., Ritchie Dep. Tr., 152:14-21, June 9, 2017); (Ex. D to Mot., Ritchie Dep. Tr., 39:16-

17; 69:11-13, May 23, 2011.) He has demonstrated no other qualifications that would 

permit him to assess the reliability or applicability of medical literature, or Dr. Betensky’s 

analysis, to support these opinions. In such circumstances, courts have limited the scope 

of an expert’s opinions where they venture into areas outside the scope 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 ‘reasonable confines’ of his clinical expertise” 

when offering opinions regarding biomedical engineering and material science, and that 

therefore the physician was not qualified to offer such opinions); See In re Silicone Breast 

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

Daubert replies. 

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Implants Litig., 318 F.Supp.2d 879, 902 (C.D. Cal. 2004) (excluding opinions about the 

defendant’s failure to conduct tests proffered by the plaintiff’s expert, who had worked in 

quality control for a pharmaceutical company, published papers about medical devices, 

and holds patents on medical devices, on the grounds that such experience is insufficient 

foundational knowledge for offering opinions on testing); Kruger v. Johnson & Johnson 

Prof’l, 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 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). The Plaintiffs make no effort to distinguish this body of cases. 

Plaintiffs simply argue that as a materials engineer, he may rely on published 

literature and Dr. Betensky’s analysis in opining that Bard filter complication rates are 

unacceptably high. However, not only is this methodology employed by Dr. Ritchie 

insufficient to make his opinion reliable, it is tantamount to no methodology at all. Thus, 

these opinions by Dr. Ritchie should be excluded. Salinas v. Amteck of Ky., Inc., 682 F. 

Supp. 2d 1022, 1030 (N.D. Cal. 2010) (in a case involving an allegedly defective scissor 

lift, excluding plaintiff’s expert because “the evidence does no[t] reflect that he employed 

a methodology that would allow him to opine as an expert, as he testified that he never 

inspected the subject scissor lift.”). Dr. Ritchie referenced a few, among the many, 

published studies on IVC filters, for example the Nicholson study, in support of his 

opinion that Bard filters have “high rates”. (Ex. A to Mot., Ritchie Dep. Tr., 134:6 to 

135:9, June 9, 2017.) Dr. Ritchie’s lack of rigorous methodology is demonstrated by the 

fact that he does not even acknowledge the flaws in the Nicholson study admitted to in 

sworn testimony given by the author, or the publication of the correction to the study. 

(Nicholson, Correction to Article About Prevalence of Fracture and Fragment 

Embolization of Bard Retrievable Vena Cava Filters, Arch. Intern. Med. 972 (June 2012), 

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attached hereto as Exhibit G.) In that regard, Dr. Ritchie nevertheless acknowledges that 

results reported in certain published literature may be overstated because they are “small 

studies.” (Ex. A to Mot., Ritchie Dep. Tr., 134:6 to 135:9, June 9, 2017.) Dr. Ritchie even 

admits he has not done an exhaustive review or analysis of the published literature. (Id. at 

137:18 to 138:13.) He fails to demonstrate in any way what his process was in reviewing 

published literature that allows him to conclude that Bard filters have “high rates.” At 

best, he merely echoes what selected published papers report, without having the 

qualifications or experience to provide a reliable analysis on what those reports actually 

show. 

Dr. Ritchie’s other methodology used to support his “high rates” opinion is his 

reliance on Dr. Betensky’s analysis. However, his characterization of her opinion is not 

what Dr. Betensky concluded at all. Dr. Betensky does not opine in her report that Bard 

rates are “high” and she certainly does not opine that any rates are “unacceptably high” 

relative to other retrievable filters. Instead, Dr. Betensky merely 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 Simon Nitinol Filter over its sales.2 Dr. Betensky 

emphasized that “the qualifier ‘reported’ is important and that’s 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.” (Betensky Austin Dep. Tr., 

2

 In addition, if Dr. Betensky’s analysis of comparative complication rates between SNF 

and Bard retrievable filters were based on valid data – and it is not -- the underlying SNF 

data Dr. Betensky used is flawed. Specifically, she used sales and adverse event 

information beginning in the year 2000, even though she was aware that “the SNF was 

launched in 1990.” (Ex. E, 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. (Betensky MDL Dep. Tr., 125:20 to 126:2, June 23, 2017, attached hereto as Exhibit 

H.) When questioned about this, Dr. Betensky conceded that she would have used the 

adverse event data for the first 10 years of the SNF if she had it, and that the failure to 

factor it into her analysis affects the results. (Id. at 122:1-13; 189:21-22.) 

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60:12-20, July 26, 2016, attached hereto as Exhibit I.) 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, by her own admission, Dr. Betensky’s RRR “could be 

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

Dr. Ritchie is not qualified to give opinions in this case regarding Bard’s filter 

complications rates. He is not qualified to characterize them as “high” or “unacceptably 

high” rates. The methodology Dr. Ritchie uses to reach this opinion is insufficient to 

insure that the opinions are reliable. Thus, these opinions of Dr. Ritchie should be 

excluded. 

B. Dr. Ritchie’s “Vicious Circle” Opinion Is Unreliable.

Dr. Ritchie’s “vicious circle” opinion (that occurrence of one complication in a 

filter leads to another) is unreliable because it is not based on sufficient data, or any 

independently verified work. Dr. Ritchie admitted he cannot say that it is more probable 

than not that one failure mode occurring in a filter will trigger another failure mode, (Ex. 

A to Mot., Ritchie Dep. Tr., 95:6:18-101:24, June 9, 2017.) Dr. Ritchie testified that the 

vicious circle of complications is “intuitively obvious” to him (Id. at 88:8-21; 88:22- 89:2) 

and he admits that determining whether one complication precedes another “is sort of 

almost an impossible question to answer.” (Id. at 97:8-10.) Dr. Ritchie provided no stepby-step methodology that he used to determine that one complication leads to another. If 

he had any methodology, it was merely relying on Dr. McMeeking’s calculations and Dr. 

Ritchie’s own intuition. Reliance on Dr. McMeeking’s calculations is insufficient to make 

this opinion of Dr. Ritchie reliable (see discussion, infra). As for his use of intuition, that 

amounts to the use of ipse dixit in place of methodology, a tactic that Daubert and its 

progeny make impermissible. See e.g. Daubert v. Merrell Dow Pharms., Inc., 43 

F.3d 1311, 1319 (9th Cir. 1995) (stating”[w]e’ve been presented with only the experts’ 

qualifications, their conclusions and their assurances of reliability. Under Daubert, that’s 

not enough.”). 

The Plaintiffs (but not Dr. Ritchie himself) then cite to a short excerpt of testimony 

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from Christopher Ganser, a Bard corporate witness, and to one published medical study, 

(the Binkert study) as support for Dr. Ritchie’s vicious circle opinion. When asked if 

tilting could put a patient at an increased risk of perforations, of migrations, of fracture, 

and of the device not working for its intended purpose, Mr. Ganser testified “the tilting 

could contribute to that.” (Pls. Br. at 7:1-11). Mr. Ganser’s conditional testimony is far 

from concrete evidence of the vicious circle Dr. Ritchie postulates. Dr. Ritchie has not 

established what qualifications Mr. Ganser had, or what information he utilized, to give 

this qualified statement, and he does not show what scientific methodology, if any, was 

behind Mr. Ganser’s statement. The Binkert article, a study of the technical success and 

safety of G2 filter retrievals in 100 patients, concluded in part that “[t]he study data show 

a significant relationship between tilt or [sic] more than 15° and migration (P < .001); 

however, there is no statistical evidence that either migration or tilt is related to 

penetration.” (Binkert, et al., Technical Success and Safety of Retrieval of the G2 Filter in 

a Prospective, Multicenter Study, 20 J. of Vascular and Interventional Radiology, 1449, 

1452 (2009), attached hereto as Exhibit J.) Without more, this study among 100 subjects 

is not sufficient proof of the vicious circle, especially when the authors specifically state 

there is no statistical evidence from their study to show that migration or tilt are related to 

penetration. 

Dr. Ritchie also refers to Dr. McMeeking’s analysis in these cases as support for 

his own opinions on the “vicious circle.” (Ex. A to Mot., Ritchie Dep. Tr., 84:1 to 91:8, 

June 9, 2017.) However, as Bard noted in its Motion, Dr. Ritchie testified that he has not 

verified any of Dr. McMeeking’s calculations, and that he defers to Dr. McMeeking on 

the results of those and how they may support this theory. (Id. at 101:25-107:1.) 

Notwithstanding Bard’s challenges to the reliability and admissibility of Dr. 

McMeeking’s separate analyses, even if one assumes Dr. McMeeking’s analyses lend 

some support to Dr. Ritchie’s vicious circle theory, an expert’s primary reliance on the 

opinions of other experts raises serious reliability questions. Expert opinions that rely on 

other expert opinions are admissible as long as the expert does not merely act as a conduit 

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for the other expert’s opinion unless the record shows that the other expert independently 

evaluated the evidence supporting 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). See also Fosmire v. Progressive Max Ins. 

Co., 277 F.R.D. 625, 629 (W.D. Wash.2011) (“Dr. Polissar’s expert report is deficient in 

several ways. First, although his opinions are based on Dr. Siskin’s data and methodology, 

there is nothing in the record to indicate that Dr. Polissar has tested Dr. Siskin’s 

underlying data to ensure its reliability or that Dr. Polissar even has access to Dr. Siskin’s 

underlying data”); In re Imperial Credit Indus., Inc. Secs. Litig., 252 F. Supp. 2d 1005, 

1012 (C.D. Cal. 2003) (“The rules do not permit an expert to rely upon excerpts from 

opinions developed by another expert for the purposes of litigation”); see also Am. Key 

Corp. v. Cole Nat’l Corp., 762 F.2d 1569, 1580 (11th Cir. 1985) (“Expert opinions 

ordinarily cannot be based upon the opinions of others whether those opinions are in 

evidence or not”). 

Dr. Ritchie’s opinions on vicious circle are unreliable because he did not employ 

any scientific method to support his theory, and instead relies on his background as an 

engineer, a conditional statement from a Bard employee, a single piece of medical 

literature without consideration of the evidence about the study’s flaws, and the 

conclusions of Dr. McMeeking without independently verifying them. 

C. Dr. Ritchie’s Criticisms of Bard’s Testing Is Unreliable. 

Bard obviously disagrees with Dr. Ritchie’s assertion that Bard’s testing was 

flawed because, according to his claim, it failed to reveal the fractures and complications 

that ultimately manifested in actual patients. (Pls. Br. at 8:19-22.) Even if Dr. Ritchie is 

qualified to opine on Bard’s testing, the complete absence of any engineering or scientific 

methodology to support his opinions that the testing was insufficient renders his opinion 

unreliable. (Ex. A to Mot., Ritchie Dep. Tr. Supp., at 36:20-37:8; 118:15-120:9; 161:4-

162:3, June 9, 2017.) Indeed, courts have excluded opinions made by learned individuals 

who failed to employ sufficient methodology to arrive at their opinions. See e.g. 

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Medtronic, Inc. v. Boston Scientific Corp., No. 99-1035 (RHK/FLN), 2002 U.S. Dist. 

LEXIS 28355, **51-56 (D. Minn. Aug. 8, 2002) (excluding as unreliable a mechanical 

engineer’s testimony that a stent was defectively designed because, although the engineer 

relied on others’ testing of the stent, the engineer did not test his hypothesis on the stents 

at issue, noting that “failure to test or validate his hypothesis, and his apparent departure 

from the level of intellectual rigor that characterizes his work in his usual professional 

practice, render his proposed opinion testimony . . . inadmissible under Rule 702”); 

Salinas v. Amteck of Ky., Inc., 682 F. Supp. 2d 1022, 1030 (N.D. Cal. 2010) (in a case 

involving an allegedly defective scissor lift, excluding plaintiff’s expert because “the 

evidence does no[t] reflect that he employed a methodology that would allow him to opine 

as an expert, as he testified that he never inspected the subject scissor lift”); Harrison v. 

Howmedica Osteomedics Corp., No. CIV 06-0745 PHX RCB, 2008 U.S. Dist. LEXIS 

26197, **40-44 (D. Ariz. Mar. 31, 2008) (finding that a metallurgical engineer’s failure to 

test an orthopedic nail and the alternative designs about which he opined weighed against 

a finding of reliability). 

If, as the Plaintiffs argue “it is self-evident that any testing of a product should be 

designed to detect complications that occur during real world use,” (Pls. Br. at 8:22-24), 

then Dr. Ritchie’s opinion on the matter is not necessary because the Plaintiffs purport 

that, even in the complicated world of medical device design, this proposition is 

essentially “common sense.” See e.g. Fujifilm Corp. v. Motorola Mobility LLC, No. 12-

cv-03587-WHO, 2015 WL 757575, at *27 (N.D. Cal. Feb. 20, 2015) (striking portions of 

expert report that were “replete with observations and inferences that jurors are perfectly 

capable of making for themselves without [expert] assistance,” even where such sections 

were “technical in nature”); Miller v. Stryker Instruments, No. CV 09-813-PHX-SRB, 

2012 WL 1718825, at *12 (D. Ariz. Mar. 29, 2012) (“the majority of Dr. Parisian’s report 

appears to state facts that could be directly presented to the jury and then make legal 

conclusions.” “Because the Court finds Dr. Parisian’s proffered testimony unhelpful to the 

trier of fact and unreliable, Defendant’s Motion to Exclude her testimony is granted.”) In 

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re: Rezulin Prod. Liab. Litig., 309 F. Supp. 2d 531, 555 (S.D.N.Y. 2004) (excluding 

expert testimony concerning the alleged downplaying of hepatotoxic effects of Rezulin in 

the published literature based on internal documents, memos, and e-mails, finding that the 

issues constituted “lay matters” and would amount to arguing from the witness stand). 

Because Dr. Ritchie did not employ any specific engineering methods to support 

his opinion that Bard’s testing was insufficient, he is doing nothing more than speculating 

as to what additional or different testing would have demonstrated; therefore, his opinion 

on Bard’s testing is unreliable and will not assist the trier-of-fact in determining the 

issues. 

D. Dr. Ritchie’s Opinion on the SNF as a Safer Alternative Design Is 

Unreliable.

Bard stands by its assertion that Dr. Ritchie is neither qualified to offer an opinion 

on what the rates are in Bard retrievable filters or in SNF filters, nor has he employed any 

scientific methodology to support the opinion that the SNF is a safer alternative design as 

compared to Bard’s retrievable filters. 

The Plaintiffs take issue with Bard’s point that the SNF, a permanent device, and 

Bard’s retrievable filters are not functionally equivalent, calling it a “false dichotomy” 

because Bard’s retrievable filters were first cleared as permanent devices. (Pls. Br. at 

9:21-27.) The Plaintiffs ignore the fact that though the Recovery and G2 are retrievable 

filters that can be placed permanently, the SNF is a permanent filter that cannot be placed 

as a retrievable filter. They do not possess all of the same design characteristics; the 

design characteristics that make the Recovery and G2 retrievable are not present in the 

SNF and account for several of the functional differences between the products. 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. Ritchie’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; therefore, Dr. Ritchie’s opinion on this 

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issue should be excluded. See 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); McCarthy v. Olin Corp., 119 F.3d 148, 155 (2d Cir. 1997) (rejecting proposed 

alternative design that lacked “functional element” present in 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”); 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 must 

exhibit same functions as allegedly defective product); Felix v. Akzo Nobel Coatings, 262 

A.D.2d 447, 448, 692 N.Y.S.2d 413 (2d Dept. 1999) (rejecting proposed alternative 

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

exhibited “functional difference[s]”). 

The Plaintiffs essentially argue that because the SNF was the predicate device for 

(was “substantially equivalent to”) the Recovery and G2 filters, that the Recovery and G2 

have the same design characteristics as the SNF. That is incorrect. The Plaintiffs conflate 

the concepts of “substantial equivalence” under FDA regulations and the legal definition 

of an alternative safer design. These are separate concepts entirely. The Plaintiffs do 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 

functionally equivalent alternative designs. The law contradicts their argument. See, e.g., 

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 

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

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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.”). 

In further support of their argument against the exclusion of Dr. Ritchie’s opinions 

that the SNF is an alternative safer product, the Plaintiffs refer the Court in their Response 

to Bard’s Motion to Exclude Opinions of Dr. Robert McMeeking (Pls. Br. (Doc. 7806), at 

14-21) where they attempt to distinguish the Felix3 and McCarthy4 opinions from the 

instant case. Both cases5 stand for the proposition that “functional differences” between 

an allegedly defective product and the proffered alternative design are fatal to a Plaintiffs’ 

case.6 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 may be integral to – but not necessarily constitute – the 

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

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

5

 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). 

6 See Felix v. Akzo Nobel Coatings, 262 A.D.2d 447, 448, 692 N.Y.S.2d 413 (2d Dept. 

1999) (rejecting proposed alternative design that was not essentially the same” as the 

allegedly defective product because it exhibited “functional difference[s]”); McCarthy v. 

Olin Corp., 119 F.3d 148, 155 (2d Cir. 1997) (rejecting proposed alternative design that 

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

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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 the filters’ underlying design characteristics integral to their 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. 

The Plaintiffs again note Dr. Ritchie’s reliance on Dr. Betensky, this time, to 

support his safer alternative design opinion. Unfortunately, Dr. Betensky’s analysis is 

unreliable in and of itself. As discussed in Section I, supra, Dr. Betensky merely 

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

proportions of anecdotal adverse events reports for the various retrievable filters over 

sales to the proportions of anecdotal adverse event reports for the SNF over SNF sales.7

Dr. Betensky emphasized that “the qualifier ‘reported’ is important and that’s 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. I, Betensky Austin 

Dep. Tr., 60:12-20.) 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, Dr. Betensky’s RRR “could be an overestimate or it could be an underestimate” of 

risk. (Id. 62:14-19.) This undermines the reliability of Dr. Betensky’s analysis and, in 

turn, Dr. Ritchie’s reliance on it. 

And, once again, expert opinions that rely on other expert opinions should only be 

admitted into evidence if the record shows that the “relying expert” independently 

evaluated the evidence supporting the other expert’s opinion. In re Toyota Motor Corp. 

7

 Bard refers the Court to Section I, p. 5, FN.1, supra, for a more complete discussion of 

the incomplete SNF data Dr. Betensky used in her analysis. 

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Unintended Acceleration Mktg. Sales Practices, and Prods. Liab. Litig., 978 F. Supp. 2d 

1053, 1066 (C.D. Cal. 2013). Dr. Ritchie did not independently verify Dr. Betensky’s 

work” (Ex. A to Mot., Ritchie Dep. Tr., 139:16-140:18, June 9, 2017); therefore, Dr. 

Ritchie’s opinion on the SNF as a safer alternative design is unreliable. 

CONCLUSION 

Because Dr. Ritchie is unqualified to opine about the topics identified above, failed 

to use scientific methodology, and/or simply relied on opinions and analyses of other 

experts without verifying those opinions, his opinions are unreliable, will not help the jury 

determine the issues, and should be excluded. 

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 

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 

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

Bard Peripheral Vascular, Inc. 

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CERTIFICATE OF SERVICE 

I hereby certify that October 18, 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 8230 Filed 10/18/17 Page 14 of 14