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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 

CERTAIN OPINIONS OF DARREN R. 

HURST, M.D., AND SUPPORTING 

MEMORANDUM OF LAW 

(Assigned to the Honorable David G. 

Campbell) 

(Oral Argument Requested) 

The fact that Dr. Hurst is an interventional radiologist does not qualify him to offer 

the meta-analysis-like opinions contained in his Rule 26 Report. It does not qualify him 

to offer opinions about IVC filters grounded in regulatory issues, engineering, 

epidemiology, or metallurgy. And being an interventional radiologist does not give Dr. 

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Hurst a pass on identifying a methodology to assure that his opinions are based on 

sufficient facts or data, that they are the product of reliable principles and methods, and 

that he reliably applied the principles and methods to the facts of this case. The Plaintiffs’ 

Response1 does nothing to address these issues. Moreover, Dr. Hurst’s opinions about 

caudal migration, issues surrounding the Meridian Filter, and “reasonable expectations of 

physicians” are his personal, speculative, and ipse dixit opinions that should be excluded. 

A. Dr. Hurst’s Opinion that Bard’s Filters Have “Much Higher Complication 

Rates” Compared to Other IVC Filters Is Inadmissible Because Dr. Hurst Is 

Not Qualified To Offer It and Has Identified No Reliable Methodology To 

Arrive at His Opinion. 

As an interventional radiologist, Dr. Hurst is undoubtedly qualified to offer 

opinions about the medical literature and his experience with IVC filters. But in offering 

opinions that Bard’s filters have “much higher complication rates” than other filters, he 

crosses a line from analyzing individual articles in the medical literature into conducting a 

meta-analysis of thousands of articles in the literature concerning various complication 

modes for many different IVC filters. In their Response Brief, the Plaintiffs have not 

identified anything in Dr. Hurst’s background that would provide the Court assurance that 

Dr. Hurst has sufficient “knowledge, skill, experience, training, or education” to offer 

such an opinion. The Plaintiffs cite Ericson v. City of Phoenix, No. CV-14-01942-PHXJAT, 2016 WL 6522805 (D. Ariz. Nov. 3, 2016), because the court allowed a nurse 

practitioner, who had “extensive” knowledge and experience about strangulation, to 

testify about the effects of an officer’s carotid hold on the decedent’s death. But here, 

nothing in the record suggests that Dr. Hurst has extensive (or any) knowledge and 

experience in conducting meta-analyses. Rather, as discussed in Bard’s Motion, Dr. Hurst 

is straying into an area outside the scope of his qualifications. 

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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Even if Dr. Hurst has sufficient qualifications to offer such an opinion, he has not 

identified any methodology by which he arrived at his opinion. He cites an article by 

Deso and claims that “the Deso study is a meta-analysis,” (Hurst Dep. Tr., 57:11-12, July 

21, 2017, excerpt attached as Exhibit A), but Deso is not a meta-analysis. A metaanalysis is a quantitative, formal, epidemiological study design used to systematically 

assess previous research studies to derive conclusions about that body of research, often 

by pooled analysis and examination of variability or heterogeneity in study results. See, 

e.g., Haidich, Meta-analysis in Medical Research, 14 Hippokratia 29 (2010). The authors 

of Deso, on the other hand, purported to conduct a literature review, and assembled rates 

for certain adverse events on a table, listing only the highest rate for each event that they 

found referenced in any particular article. (Deso, Evidence-Based Evaluation of Inferior 

Vena Cava Filter Complications Based on Filter Type, 33 Seminars in Interventional 

Radiology 93, 97 (2016), attached as Exhibit B.) Thus, Dr. Hurst’s reliance on Deso does 

not support his opinion that Bard’s filters have “much higher complication rates” than 

other filters because Deso is not a meta-analysis.2

In arriving at his opinions, Dr. Hurst identifies 67 articles on his list of “Literature 

Reviewed,” 19 of which are editorials, guidelines, or literature reviews, such as the Deso 

article; and the substantial majority of the remaining 48 articles involve Bard filters (by 

comparison, Deso, which was just a literature review, searched over 1400 articles 

concerning 24 different filters). The number of articles on Dr. Hurst’s “Literature 

Reviewed” list is far too small, and limited almost exclusively to Bard filters, to allow for 

the meta-analysis-like opinion regarding all filters that he offers. And Dr. Hurst does not 

identify if and how he conducted an epidemiological study that systematically assessed 

this medical literature to derive his conclusion that Bard’s filters have “much higher 

complication rates” than other filters. 

2

 At best, the Deso article would support an opinion that the Bard filters have rates that 

have been reported up to the highest rate identified by Deso for any particular 

complication. 

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The Plaintiffs also argue that “with regard to his opinions about complication rates, 

Dr. Hurst found further support in Bard’s internal documents.” (Pls. Resp. Br. (Doc. 

7811), at 6.) The Plaintiffs’ counsel, however, provided Dr. Hurst with only 24 Bard 

internal e-mails and documents from among the 1.5 million documents produced in the 

litigation (0.0016%). Dr. Hurst does not identify how these documents played into 

arriving at a meta-analysis-like opinion. Such a threadbare basis for his opinion provides 

no assurances that Dr. Hurst’s opinion is based on sufficient facts or data, that it is the 

product of reliable principles and methods, or that he reliably applied the principles and 

methods to the facts of this case. See Kumho Tire Co. v. Carmichael, 119 S.Ct. 1167, 

1176 (1999) (Daubert requires the trial court to assure itself that the expert “employs in 

the courtroom the same level of intellectual rigor that characterizes the practice of an 

expert in the relevant field”). 

In short, Dr. Hurst offers a meta-analysis-like opinion without any evidence in his 

background that he is qualified to offer such an opinion. And even if he were qualified, 

reliance on a single article that is not a meta-analysis and 24 internal Bard documents is an 

insufficient basis from which to derive such an analysis. Dr. Hurst identifies no 

methodology that he used to reliably arrive at his opinion that Bard’s filters have “much 

higher complication rates” than other filters. Accordingly, the opinion should be 

excluded. 

B. Dr. Hurst’s Opinion that Bard’s Filters Have “The Unacceptable Risk of 

Caudal Migration” Is an Inadmissible Ipse Dixit Opinion. 

In their Response, the Plaintiffs have not identified any reliable basis or 

methodology for Dr. Hurst’s opinion that Bard’s G2, G2X, and Eclipse filters have an 

“unacceptable risk of caudal migration” or a “significant increased safety risk of caudal 

migration . . . over competitor filters.” (Ex. A to Mot, Hurst Rule 26 Report Regarding Pl. 

Mulkey, at 10.) Nor could they, as Dr. Hurst appears to use his own definition of caudal 

migration that is different than how the term is discussed in the medical literature. “When 

I talk about the Bard filters and caudal migration, what I mean is basically a settling that 

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occurs with the filters, a splaying out of the legs.” (Hurst Dep. Tr., 231:16-19, Aug. 7, 

2017, excerpts attached as Exhibit C.) The medical literature discusses caudal migration, 

and migration in general, as “a change in filter position compared to its deployed position 

(either cranial or caudal) of >2 cm as documented by plain-film imaging, CT, or 

venography.” (ACR-SIR-SPR, Practice Parameter for the Performance of Inferior Vena 

Cava (IVC) Filter Placement for the Prevention of Pulmonary Embolism, at 3 (2016), 

attached as Exhibit D; Ex. B, Deso Article, at 94 (discussing migration as “movement of 

an IVC filter greater than 2 cm along the IVC beyond the initial placement position.”).) 

Bard is aware of no article in the medical literature discussing caudal migration in the 

terms that Dr. Hurst defines it. Nor is Bard aware of articles in the medical literature 

comparing rates of caudal migration across different filters. Thus, Dr. Hurst’s opinions 

can find no support in the literature. As such, the opinions are classic ipse dixit, 

inadmissible opinions. General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997) (“nothing 

in either Daubert or the Federal Rules of Evidence requires a district court to admit 

opinion evidence which is connected to existing data only by the ipse dixit of the expert”). 

C. Dr. Hurst’s Regulatory-Based, Engineering-Based, Metallurgical-Based, and 

Subjective Opinions Should Be Excluded Because He Does Not Have the 

Requisite Qualifications and Has Not Identified a Reliable Methodology To 

Arrive at the Opinions. 

In their Response, the Plaintiffs argue that “[i]t is as a treating physician who has 

implanted and retrieved IVC filters, served as an intermediary between the IVC 

manufacturers and patients, and conducted risk benefit analyses that Dr. Hurst provides 

opinions” (Pls. Resp. Br. at 8) about “early safety signals,” “in vitro testing,” “minimum 

arbitrary threshold for migration resistance,” “ignoring their in-house studies, [and] risk 

analysis,” “marketing materials falsely represent[ing]” newer generations of filters that 

were “unproven in their safety and efficacy,” and that “patients [] were unknowingly 

participating in a decade-long open experiment with Bard retrievable filters.” (Ex. A. to 

Mot., Rule 26 Report at 11.) The Plaintiffs have not identified what in Dr. Hurst’s 

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background as a treating physician allows him to render opinions about these issues or 

how his opinions are methodologically sound enough to reliably allow him reach them. 

For example, the term “signals” is a regulatory and epidemiological concept. 

Evaluation of “in vitro testing” and “migration resistance” are engineering issues. 

Concluding that marketing materials “falsely represented newer generation devices as 

greatly improved strength and stability” requires engineering and metallurgical knowledge 

to determine relative strength and stability across devices. In their Response Brief, the 

Plaintiffs have not identified anything in Dr. Hurst’s background that would provide the 

Court assurance that Dr. Hurst has sufficient “knowledge, skill, experience, training, or 

education” to offer these opinions. 

Even if Dr. Hurst had sufficient qualifications to offer such an opinion, he has not 

identified any methodology by which he arrived at his opinions. While many of his 

opinions implicate Bard’s bench testing of its filters, Dr. Hurst testified that he has only 

seen some of the bench test data, he has not reviewed Bard’s 510(k) submissions, and he 

has not seen any of the various submissions that Bard made to the FDA concerning test 

data. (Ex. A, Hurst Dep. Tr., 69:8-14; 70:11-19.) Dr. Hurst reviewed only 24 internal 

Bard e-mails and documents in arriving at the many opinions that he provides in his Rule 

26 Report. The Plaintiffs have not addressed how such a limited number of documents 

constitutes a methodologically sound way to allow Dr. Hurst to reliably make his broad 

opinions that Bard “ignor[ed] their in-house studies, [and] risks analysis,” that Bard’s 

“marketing materials falsely represented newer generation devices,” that Bard’s filters 

were “unproven in their safety and efficacy,” and that Bard was using patients as 

“unknowing[] participant[s] in a decade-long open experiment with Bard retrievable 

filters.” Nor has Dr. Hurst identified any objective standards that he used to arrive at his 

opinions. These types of opinions, therefore, should be excluded. See, e.g., Staub v. Breg, 

Inc., No. CV 10-02038-PHX-FJM, 2012 WL 1078335, at *3 (D. Ariz. Mar. 30, 2012) 

(finding that the expert’s opinions must be grounded in “objective standards” and that any 

opinions “grounded on nothing more than her personal views will be excluded.”). 

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D. The Plaintiffs Improperly Attempt To Shift the Burden of Proof Regarding 

Admissibility of Dr. Hurst’s Opinions Premised on the Meridian Filter. 

The Plaintiffs have the burden of proving the admissibility of Dr. Hurst’s opinions 

that Bard should never have launched the G2/G2X Filter or the Eclipse Filter because the 

Plaintiffs experienced complications of caudal migration and tilt that the Meridian filter 

attempted to correct. (Ex. A to Mot., Rule 26 Report, at 11.) Dr. Hurst, however, never 

implanted a Meridian Filter. (Ex. A, Hurst Dep. Tr., 102:18-21.) He does not know the 

rates of complication regarding the Meridian Filter. (Id. at 102:22-25.) He does not know 

how the rates of complication for the Meridian Filter compares to the G2/G2X Filter or 

Eclipse Filter. (See id. at 103:1-8.) The Deso article that Dr. Hurst relies on so heavily for 

his opinions about complication rates does not identify any rates of complications reported 

for the Meridian Filter. (Ex. B, Deso article, at 97.) Bard is aware of no studies published 

in the medical literature concerning the Meridian Filter, and is aware of only two case 

reports in the medical literature reporting that a patient’s Meridian Filter fractured. And 

the Plaintiffs’ challenge in their Response Brief that Bard should identify documents or 

deposition testimony about what it communicated to physicians has no bearing on whether 

Dr. Hurst’s opinions about the Meridian Filter relative to Bard’s earlier generation filters 

have any indicia of reliability. 

In short, Dr. Hurst simply has no basis on which to opine that the Meridian Filter 

was any better or worse than Bard’s previous generation filters. Therefore, Dr. Hurst’s 

opinions about what Bard should have done with its previous generation filters, and what 

Bard should have communicated to physicians concerning these filters,3 all of which is 

grounded in Dr. Hurst’s description of the Meridian Filter, necessarily are speculative 

3

 As discussed in Bard’s Motion, Dr. Hurst’s opinions about what Bard communicated 

with physicians nationally are likewise speculative. (Mot. at 11.) Dr. Hurst’s knowledge 

about Bard’s marketing is limited to his personal experience with Bard’s sales 

representatives, and “I haven’t seen him [Bard’s sales representative] in years.” (Ex. A, 

Hurst Dep. Tr., at 69:3-4.) Although the Plaintiffs argue that Dr. Hurst reviewed 

marketing documents to determine what Bard told physicians nationally, none of the 

documents identified on his “Bard Materials and Depositions Reviewed” are promotional 

pieces for physicians. (Ex. A to Mot., Rule 26 Report, at Appendix.) 

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opinions that should be excluded. 

E. Dr. Hurst’s Opinions about “Reasonable Expectations of Physicians” and 

“Informed Consent” Are Inadmissible. 

Part and parcel of Dr. Hurst’s opinions about what Bard should have discussed 

with physicians are his opinions about the “reasonable expectations of physicians” and 

“informed consent,” which the Plaintiffs discuss at length in their Response. (Pls. Resp. 

Br., at 4-5, 10-11.) These opinions, however, are inadmissible because they are not 

grounded in any reliable sources of authority and they do not satisfy any of the Daubert 

factors (i.e., they have not been tested or peer reviewed, they have no known rate of error, 

they have not been published, and the physicians have not identified their view as 

generally accepted in the medical community).4 The Plaintiffs have not identified any 

cases where opinions about “reasonable expectations” of a physician in an “informed 

consent” context were admitted in a product liability case. Indeed, informed consent is 

not an element of any claim or defense, as it is strictly a medical malpractice concept; the 

Plaintiffs have cited nothing to the contrary, and Dr. Hurst’s opinions, therefore, do not 

“fit” the case. The only cases that the Plaintiffs cite in their Response concerning 

informed consent are medical malpractice cases. Scharf v. Trabucco, No. 3:14-cv-8183-

HRH, 2017 WL 105993 (D. Ariz. Jan. 11, 2017) (medical malpractice case premised on a 

hospital’s failure to meet the standard of care regarding informed consent); Saccuci v. 

United States, No. CV-07-1277-PHX-GMS, 2009 WL 1531842 (D. Ariz. June 2, 2009) 

4

In re Rezulin Prod. Liab. Litig., 309 F. Supp. 2d 531, 556-57 (S.D.N.Y. 2004) (rejecting 

the Plaintiffs’ arguments that their physician expert was “articulating general principles 

that physicians require accurate information on labels to make informed decisions” 

because “the clear import” of the opinions is that physicians would not have prescribed 

the Rezulin if different information had been provided to the medical community, which 

is speculative and therefore inadmissible); In re Diet Drugs Prod. Liab. Litig., No. MDL 

1203, 2001 WL 454586, at *18 (E.D. Pa. Feb. 1, 2001) (excluding an expert’s opinion 

about how physicians would think and act if the company had provided additional adverse 

event information); In re Diet Drugs Prod. Liab. Litig., No. MDL 1203, 2000 WL 

876900, at *12 (E.D. Pa. June 20, 2000) (“The court can easily preclude, from a Daubert

viewpoint, the rendering of opinions by either of these [physician] witnesses as to a label's 

compliance with federal regulatory requirements or as to what doctors in general think, 

because the witnesses are not qualified for that.”). 

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(medical malpractice informed consent case). Finally, the “informed consent” AMA 

Code of Medical Ethics provision and opinion that Dr. Hurst cite in his Rule 26 Report, 

(Ex. A to Mot., Rule 26 Rep., at 8), say nothing about the information required to satisfy 

informed consent, such that Dr. Hurst’s thoughts about what is required to satisfy 

informed consent are his personal and ipse dixit opinions. Thus, Dr. Hurst’s opinions 

about “reasonable expectations of physicians” and “informed consent” should be excluded 

as part of excluding his opinions about what Bard told and should have told physicians. 

CONCLUSION

The Plaintiffs have not met their burden of proof that Dr. Hurst’s broad opinions 

should be admitted. Accordingly, the Court should limit his opinions to his proper areas 

of expertise concerning his clinical experience with IVC filters, interpretation and analysis 

of the Plaintiffs’ radiological medical records, and his interpretation of articles in the 

medical literature. 

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 

Attorneys 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 e-mail 

notification of such filing to all attorneys of record. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

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