1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 

Ramon Rossi Lopez - rlopez@lopezmchugh.com

(California Bar Number 86361; admitted pro hac vice)

Lopez McHugh LLP 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

949-812-5771 

Mark S. O’Connor (011029) 

mark.oconnor@gknet.com 

Gallagher & Kennedy, P.A. 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

602-530-8000 

Co-Lead/Liaison Counsel for Plaintiffs 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

In Re Bard IVC Filters Products 

Liability Litigation 

No. MD-15-02641-PHX-DGC

PLAINTIFFS’ REPLY MEMORANDUM 

IN SUPPORT OF MOTION TO 

EXCLUDE OPINIONS AND 

TESTIMONY OF 

CHRISTOPHER S. MORRIS, M.D. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 1 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 1 - 

Plaintiffs respectfully submit this Reply Memorandum in Support of Plaintiffs’ 

Motion to Exclude the Opinions and Testimony of Christopher S. Morris, M.D. 

I. INTRODUCTION 

Christopher S. Morris, M.D., is an interventional radiologist who is being offered 

as an expert by Bard. Among Dr. Morris’s opinions, he offers that Bard’s filters are safe 

and effective, that imaging of patients pre-retrieval is unnecessary, that complications 

have no bearing on the decision to remove filters, and that filters that have been in place 

long-term do not need imaging or medical monitoring follow-up. The Court should 

exclude Dr. Morris’s opinions because his sweeping and unsupported claims about the 

safety and efficacy of Bard filters, as well as claims about imaging and retrieval are 

outside the medical mainstream and are based on an unsound methodology. 

Bard bears the burden of proving that Dr. Morris’ testimony is admissible. See, 

e.g., Lust v. Merrell Dow Pharmaceuticals, Inc., 89 F.3d 594, 598 (9th Cir. 1996). Bard 

has failed to carry its burden. In their opening brief, Plaintiffs showed that Dr. Morris 

disregarded a range of peer-reviewed studies identifying the risks of Bard IVC filters, 

ignored literature recognizing the need for medical imaging during patient follow-up, 

criticized, without basis, the need to diagnose complications as part of a follow-up 

program, and overlooked the needs of patients with long-indwell filters. Plaintiffs 

demonstrated that Dr. Morris did not base his opinions regarding the safety of IVC filters 

and the need for follow-up on sufficient facts or data and did not utilize sound 

methodology, that he ignored relevant medical literature, and refused to even consider 

Bard’s internal information and data. Plaintiffs also demonstrated that Dr. Morris did not 

substantiate his opinions regarding the use of medical imaging during follow-up and 

whether asymptomatic patients require medical imaging, ignoring the medical 

community’s guidance and again disregarding relevant medical literature. 

Bard’s response fails to justify these failures of methodology and approach, and 

Dr. Morris’s testimony should be excluded. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 2 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 2 - 

II. ARGUMENT 

A. Dr. Morris Does Not Utilize Sound Methodology in Forming his 

Opinions About Safety and the Need for Follow-Up Imaging. 

Federal Rule of Evidence 702 permits a witness to give expert testimony if “(1) 

the testimony is based upon sufficient facts or data, (2) the testimony is the product of 

reliable principles and methods, and (3) the witness has applied the principles and 

methods reliably to the facts of the case.” Fed. R. Evid. 702. In making his opinions 

about the safety of Bard IVC and about whether imaging during follow-up is needed for 

purposes of finding complications during follow-up, Dr. Morris did not rely on sufficient 

facts or data and did not utilize reliable principles and methods because he selectively 

ignored medical literature finding increased fracture rates and ignored Bard’s own 

internal data. 

1. Dr. Morris Did Not Adequately Consider the Medical 

Literature. 

Dr. Morris opines that Bard IVC filters are safe and effective and that imaging is 

not necessary to identify complications.1

 Bard’s attempt to show that Dr. Morris 

adequately reviewed the relevant medical literature (Defendant’s Opposition, ECF No. 

7800 (hereinafter “Br.”) at 6-8) in forming these conclusions fails. Plaintiffs 

demonstrated, and his testimony shows, that Dr. Morris subjectively dismissed or ignored 

swaths of literature demonstrating the increased long-term fracture rates of Bard IVC 

filters.2

 Meanwhile, Dr. Morris cherry-picked articles with only short-term follow-up in 

 

1

 Ex. 3, MDL Rep. at 13, 21. 

2

 Q. And nobody has criticized [the An study] in the peer-reviewed literature since 

it's been published, to your knowledge, have they? 

A. I haven't looked for that specifically, so I don't know. 

Ex. 4, Morris Dep. at 187:2-6. 

Q. Nobody, to your knowledge, has published any critique of the results of [the 

Tam] study, have they? 

A. I haven't looked for those, so I don't know. 

Id. at 188:6-8. 

Q. You’re aware that the Nicholson study that you’re critical of has been relied 

upon and cited by a number of experts in the field in papers that they have 

published in the peer-reviewed literature, right? 

Footnote continued on next page

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 3 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 3 - 

an effort to minimize the apparent fracture rates.3 Dr. Morris let his own subjective 

views—even describing complication concerns as “melodrama” – color his view of the 

literature when he formed his opinions; he did not appropriately consider the medical 

literature identifying the risks of Bard IVC filters, especially the increasing risks over 

time.4

 When an expert “reaches his opinion by first identifying his conclusion ... and 

then cherry-picking observational studies that support his conclusion,” that opinion “does 

not reflect scientific knowledge, is not derived by the scientific method, and is not ‘good 

 

Footnote continued from previous page

A. Unfortunately, it’s all that is out there. That’s what’s available. 

Q. Am I correct in what I just stated? 

A. I think that’s true, yes. Sad but true. 

Id. at 189:21-190:4. 

Q. You now have a section following this where you talk about frequently studied 

-- cited studies of low fracture complications for IVC filters, right? 

A. Correct. 

Q. And your paper cites to the Cantwell study? 

A. Yes. 

Q. Right? It cites to the Binkert study? 

A. Yes. 

Q. Right? The Mitsunaga study? 

A. Yes. 

Q. The Damascelli study? 

A. Yes. 

Q. The Charles study? 

A. Yes. 

Q. Those studies are all studies without long-term follow-up; isn’t that correct? 

A. That’s -- 

MR. ROGERS: Object to the form. 

A. That is true. 

Ex. 4, Morris Dep. at 191:21-192:15. 

4

 Q. You -- you agree with me that that's a legitimate question that doctors have 

about patients with embedded -- with implanted filters? 

MR. ROGERS: Object to the form. 

A. I think with all the melodrama that has occurred in this whole -- related to all 

this -- all these issues, that patients are definitely concerned about the status of the 

filter in that situation, yes. 

Q. Is the Kalva paper melodrama? 

A. No. But when we turn on the nightly news and we hear, you know, 

advertisements about filter injuries and all that, that creates an aura of concern 

among patients, yes. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 4 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 4 - 

science.’” See In re Bextra & Celebrex Mktg. Sales Practices & Prods. Liab. Litig., 524 

F. Supp. 2d 1166, 1176 (N.D. Cal. 2007). 

Bard attempts to justify Dr. Morris’s dismissal of studies finding increased 

complication rates over time, asserting that he gave reasons for this dismissal, but those 

justifications fail. Br. at 7. For example, Bard argues that Dr. Morris believed the An, et 

al.5

 authors “may have inappropriately used numerators and denominators with different 

prevalence calculators” which made the fracture rate “artificially high.” Id. Yet 

Dr. Morris did not cite independent evidence, nor any peer-reviewed literature, that ever 

criticized the An study for this reason or that disagreed with its findings of high fracture 

rates and increasing fracture rates over time. He conceded in his deposition he was 

unaware of such evidence or literature.6

 Dr. Morris also ignored the fact that the An 

study, like other studies Plaintiffs cited finding increased fracture rates,7

 have been cited 

 

5

 All Exhibit references are to those attached to Plaintiffs’ original motion, ECF No. 

7320: See Ex. 7, Tianzhi An, MD, et al., Prevalence and Clinical Consequences of 

Fracture and Fragment Migration of the Bard G2 Filter: Imaging and Clinical Followup in 684 Implantations, 25 J. Vasc. Interv. Radiol. 941 (June 2014). 

6

 Q. And you’re not aware of anybody that’s been critical in -- in any published 

submission to any journal regarding the conclusions of the An paper, are you? 

A. “I have not known of any of those. I did not specifically look for any of those. 

Ex. 4, Morris Dep. at 187:2-6; 

Q. So you don’t -- you’re not aware of anybody that has been critical of the use of 

the Kaplan-Meier survival estimate as it was used in this Tam study to conclude 

that there was a five-year fracture rate of 40 percent? 

A. I believe a lot of experts would argue that the way it was used here would not 

be that -- would not be scientifically valid to a high degree because -- I think of the 

reasons I cited here, you know, high censored -- high number of censored events. 

The fudge factor is a little -- little high here. 

Id. at 187:13-23. 

7 See, e.g., Ex. 7, Tianzhi An, MD, et al., Prevalence and Clinical Consequences of 

Fracture and Fragment Migration of the Bard G2 Filter: Imaging and Clinical Followup in 684 Implantations, 25 J. Vasc. Interv. Radiol. 941 (June 2014); Ex. 8, Matthew D. 

Tam, MD, et al., Fracture and Distant Migration of the Bard Recovery Filter: A 

Retrospective Review of 363 Implantations for Potentially Life-Threatening 

Complications, 23 J. Vasc. Interv. Radiol. 199 (Feb. 2012); Ex. 9, William Nicholson, 

MD et al., Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena 

Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Arch. Intern. Med., at E3 (Aug. 9, 2010); Ex. 10, Jeffrey E. Hull, MD et al., Bard 

Recovery Filter: Evaluation and Management of Vena Cava Limb Perforation, Fracture, 

and Migration, 20 J. Vasc. Interv. Radiol. 52 (Jan. 2009). 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 5 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 5 - 

to and relied upon by multiple peer-reviewed publications. This too he conceded at his 

deposition. Ex. 4, Morris Dep. at 189:18-190:10. Dr. Morris cherry-picked studies with 

short-term follow up as “evidence” of the safety of Bard IVC filters, while subjectively 

disagreeing with the findings of the peer-reviewed studies that demonstrate high 

complication rates over increasing periods of indwelling time.8

Tellingly, the only study whose findings Dr. Morris agreed with, and to which 

Bard characterizes as a long-term study, is Mitsunaga, et al.,

9

 and Bard relegates that 

discussion to a footnote. See Br. at 8, n.7. First, the Mitsunaga authors acknowledged 

the validity of studies such as Nicholson et al., Vijay et al., and Tam et al., which found 

high complication rates in Bard IVC filters.10 Second, the Mitsunaga authors specifically 

stated that “there was no formal plan or protocol in place for follow-up in these patients 

during the study period” and therefore they could not appropriately identify 

complications.11 Furthermore, the Mitsunaga study was primarily conducted on cancer 

patients, and most of those patients died within 6 months of filter placement.12 As such, 

it should not realistically be considered a long-term study as Bard proposes. Moreover, 

8

 Q. And in the medical literature, when somebody publishes a study, there's a 

mechanism for other experts in the field to -- to comment if they agree or disagree 

by writing their own opinions and getting those opinions published, either in the 

form of a letter to the editor of the journal or some other type of communication in 

the professional literature, correct? 

A. Correct. 

Q. And so if you disagreed, as you claim to here in your testimony, with the 

conclusion of the five-year fracture rate at 40 percent, there was -- there was an 

avenue for you to publish your opinion about that, right? 

MR. ROGERS: Object to the form. 

A. Theoretically, yes. That -- that – my opinion would then have to be accepted by 

the peer review process just like everything else. These journals just don't publish 

any -- any letter that they ever receive. 

Q. Of course. 

A. It goes through a process to get to the state of publication. 

Ex. 4, Morris Dep. At 185:17-186:15. 

9 See Ex. A to Br., Mitsunaga, et al., Fracture Rate and Serious Complications of Vena 

Cava Filters, 3 Open J. of Radiol. 85-90 (June 2013). 

10 Id. at 88. 

11 Id. at 89. 

12 Id. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 6 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 6 - 

Dr. Morris himself agreed that Mitsunaga was a short-term study. Morris Dep. at 191:21-

192:15. Bard’s contention that this study (and only this study) is an example of long term 

follow-up data relied upon by Dr. Morris is a glaring indicator that long-term studies that 

find Bard’s IVC filters to be safe do not exist. Meanwhile, numerous studies that have 

been cited to by the FDA and the medical community identify increasing complication 

rates the longer that Bard IVC filters remain indwell. Because Dr. Morris selectively 

ignored these studies, his opinions should be excluded. 

2. Dr. Morris’s Opinions Are Not Based on Sufficient Facts or Data 

and Are Not Reliable Because He Selectively Ignores Bard’s 

Internal Information. 

Bard argues, without basis, that Dr. Morris relied on sufficient underlying facts or 

data in forming his opinions despite Bard’s refusal to show him, and Dr. Morris’s refusal 

to even look at, internal company documents. See Br. at 8-11. Evaluation of an expert’s 

opinion testimony “requires consideration of the overall sufficiency of the underlying 

facts and data, and the reliability of the methods, as well as the fit of the methods to the 

facts of the case.” United States v. W.R. Grace, 504 F.3d 745, 765 (9th Cir.2007). An 

expert’s opinion may be unreliable if he fails to account for contrary scientific literature 

and instead “selectively [chooses] his support from the scientific landscape.” In re 

Rezulin Products Liab. Litig., 369 F. Supp. 2d 398, 425 (S.D.N.Y.2005) (quotations 

omitted). “[I]f the relevant scientific literature contains evidence tending to refute the 

expert’s theory and the expert does not acknowledge or account for that evidence, the 

expert’s opinion is unreliable.” Id.; see also Abarca v. Franklin Cnty. Water Dist., 761 F. 

Supp. 2d 1007, 1066 n.60 (E.D. Cal. 2011) (“A scientist might well pick data from many 

different sources to serve as circumstantial evidence for a particular hypothesis, but a 

reliable expert would not ignore contrary data, misstate the findings of others, make 

sweeping statements without support, and cite papers that do not provide the support 

asserted.” (quotations omitted)) “Reliance on literature and experience is not dispositive” 

where the court must also ensure that the expert has reliably applied the methodology to 

the facts of the case with “the same level of intellectual rigor that characterizes the 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 7 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 7 - 

practice of an expert in [that] field.” Trevino v. Boston Sci. Corp., No. 2:13-CV-01617, 

2016 WL 2939521, at *12 (S.D.W. Va. May 19, 2016) (citing Kumho Tire Co., Ltd. v. 

Carmichael, 526 U.S. 137, 152 (1999)). Where there is no indication of the reasoning 

and methods underlying an expert witness’s conclusion, the Court cannot make the 

necessary findings of reliability and utility to a fact-finder under Fed. R. Evid. 702. Such 

conclusions are properly excluded. See Claar v. Burlington Northern R. Co., 29 F.3d 

499, 502 (9th Cir. 1994). 

Bard incorrectly argues that courts disapprove of medical experts’ reliance on 

internal company documents.13 See Br. at 10-11. Rather, internal documents often help 

the expert develop and reinforce their opinions. See, Wise v. C.R. Bard, Inc., No. 2:12-

CV-01378, 2015 WL 521202, at *15 (S.D.W. Va. Feb. 7, 2015) (“Dr. Raybon has 

properly used Bard’s internal documents to develop and reinforce his opinions rather than 

to narrate Bard’s corporate conduct. Furthermore, many of the internal documents relied 

upon by Dr. Raybon could stand alone as medical research and literature.”); In re Mentor 

Corp. ObTape Transobturator Sling Prod. Liab. Litig., 711 F. Supp. 2d 1348, 1368 

(M.D. Ga. 2010) (“[T]he experts’ reliance on the journal articles and Mentor’s internal 

documents does not diminish the weight that the Court gives to the experts’ opinions, 

assuming that the opinions are otherwise sufficiently reliable.”). Bard cites In re Mirena 

IUD Prod. Liab. Litig., 169 F. Supp. 3d 396, 426 (S.D.N.Y. 2016), contending that the 

court there did not exclude the defendants’ expert’s testimony merely because it 

contradicted statements made by the defendants’ employees. See Br. at 7-8. Plaintiffs 

are not suggesting that Bard’s internal documents are important only because they 

 

13The court in Soldo v. Sandoz, 244 F. Supp. 2d 434, 64 (W.D. Pa. 2003), excluded a 

causation opinion not merely because it was based on internal documents, but because 

the methodology for making “causality assessments” was not adequately described in the 

documents. The courts in Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 991 (8th 

Cir. 2001) and Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1046, 1052-53 (S.D. Ill. 

2001) both excluded causation opinions because they were based on out of context 

statements lifted from internal memoranda, that when placed in context, indicated a 

different conclusion than the experts asserted. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 8 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 8 - 

contain conflicting statements to Dr. Morris’s testimony, but that the documents contain 

information and data that is necessary for Dr. Morris to opine as he does on Bard’s IVC 

filters. The internal documents here contain, among other things, years of failure analysis 

and testing data which provide the best source of information regarding the safety of 

Bard’s IVC filters. Thus, the facts here are more similar to Wise v. C.R. Bard, Inc., 

where the court found that internal documents would be needed to reinforce the expert’s 

statement and could stand alone as medical research and literature. See 2015 WL 521202, 

at *15. 

Bard suggests that practicing medical doctors have no need to see internal 

documents in the ordinary course of their practice, and therefore Dr. Morris had no need 

to see Bard’s internal documents when forming his opinions. See Br. at 9. Bard’s 

argument ignores the obvious distinction between the sweeping opinions about device 

efficacy that Dr. Morris is offering and what a “practicing medical doctor” would 

typically make. For instance, Dr. Morris opines that Bard’s IVC filters are safe and 

effective based on his “review of the available literature and his personal experience.” 

Ex. 3, MDL Rep. at 21. Setting aside that he selectively ignored the available literature 

recognizing the dangers of Bard IVC filters, a practicing medical doctor cannot 

accurately assess safety without reviewing all the available information. He testified that 

in doing an evaluation of IVC filters, he would want to know about evidence that a filter 

had a structural weakness or a high incidence of fracture. Ex. 4, Morris Dep. 199:3-

200:3. Yet he stated that he would never want to know about Bard’s internal studies, 

such as Bard’s comparisons of its filters to competitors’ products or failure analyses. He 

cannot have it both ways. 

Bard’s other proffered justifications for Dr. Morris failure to review internal 

documents also fail. Its assertions that bellwether plaintiffs’ implanting doctors did not 

review Bard internal information either are irrelevant. Those doctors were testifying with 

regard to facts and circumstances with regard to specific patients’ treatments; they were 

not expounding, like Dr. Morris, on the overall level of safety of Bard’s filters. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 9 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 9 - 

Meanwhile, Plaintiffs’ experts’ reports demonstrate that Bard’s retrievable filters 

are not safe and should not have been placed on the market based on a broader review of 

evidence that includes Bard’s internal documents. Yet Dr. Morris seeks to criticize their 

opinions without reviewing the same information. For example, Dr. Morris criticizes 

Plaintiffs’ experts Drs. Kinney Roberts, and Kalva, who find that Bard used insufficient 

data to support the market launch of certain filters. Ex. 3, MDL Rep. at 20-21. Dr. 

Morris notes how their report analyzes internal Bard documents, including 

communications and bench top testing, and that he never reviewed that information. Id. 

at 20. Yet without reviewing these documents himself, however, Dr. Morris opines that 

their report does not tell an “important story” about the innovation of Bard IVC filters. 

Id. Dr. Morris then concludes that Bard’s method of technological improvement may be 

interpreted as “quality improvement.” Id. In making this assessment, Dr. Morris ignores 

extensive details gleaned from the underlying documents and lacks the broader frame of 

reference within which Plaintiffs’ experts made their opinions. Dr. Morris points to no 

evidence of Bard’s reasoning behind its changes to its filters which would support his 

opinion. He also makes no assessment of the safety concerns that Bard considered during 

its decision-making. Rather than request or review the relevant documents or data, he 

willingly ignored them. 

Bard’s internal information serves an important basis for determining the overall 

complication rates of Bard’s IVC filters, relative safety, and the necessity of a monitoring 

protocol. Reliance on literature and experience is not dispositive here because the court 

must also ensure that the expert has reliably applied his methodology to the facts of the 

case with “the same level of intellectual rigor that characterizes the practice of an expert 

in [that] field.” Kumho, 526 U.S. at 152. Dr. Morris’s opinions cannot survive because 

he admitted that he has “never received confidential internal manufacturer 

communications, memoranda, in‐house bench top and animal research, electronic mail, 

PowerPoint presentations, or product documents from Bard.” MDL Report at 27. Such 

opinions are not reliable. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 10 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 10 - 

The Court in Trevino came to the same conclusion in a closely analogous situation 

in which a party’s expert did not review the relevant internal documents. See, Trevino, 

2016 WL 2939521, at *12-13. The Trevino court held that “regardless of the literature he 

has reviewed or the experience he has gained, a necessary piece of data remains missing 

from [the expert’s] methodology” and “[w]ithout any reliable, demonstrated knowledge 

of [the defendant’s] internal design procedures, [the expert] cannot substantiate his 

opinion that these procedures were departures from the norm, not followed by [the 

defendant], or lacking in any way.” Id. at 13. Without properly assessing Bard’s internal 

information, Dr. Morris’s methodology lacks sufficient facts or data to sufficiently form 

an opinion about Bard’s IVC filters’ safety and effectiveness and/or to rebut Plaintiffs’ 

experts’ opinions thereto. Therefore, Dr. Morris’s opinions should be excluded. 

B. Dr. Morris’s Opinions About Imaging and Follow-Up Are 

Unsubstantiated and Unreliable. 

1. Bard’s Argument that the SIR Reporting Standards do not Set 

Forth Follow-up Standards Requiring Imaging is Unfounded. 

Plaintiffs’ opening brief showed that Dr. Morris failed to recognize key literature 

that suggests that imaging should be used during a follow-up program. In opining that 

imaging should not be used in such a program, Dr. Morris claimed that “no authoritative 

society or organization has specifically recommended imaging as part of a surveillance or 

medical monitoring program regarding [IVC filters].” Ex. 3, MDL Rep. at 16. Dr. 

Morris’s opinion ignored several Reporting Standards that Bard cites to in its own IFUs 

which suggest that imaging should be used as a minimum part of a follow-up program. 

In ignoring basic documents that Bard itself relies upon in the same subject area, Dr. 

Morris failed to base his opinion “upon sufficient facts or data” and failed to use reliable 

principles and methods” as applied to the facts of this case. See Fed. R. Evid. 702. 

In trying to buttress Dr. Morris’s opinion, Bard attempts to parse the Reporting 

Standards in a manner that is in tension with the language of the standards themselves. 

Bard argues that the Reporting Standards are not to be followed by clinicians, and instead 

should only to be used as a guidance for physicians reporting IVC usage in medical 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 11 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 11 - 

literature. Br. at 14-17. Although Bard could not point to anything in these Reporting 

Standards directly stating that their guidance are exclusively for medical literature use, 

Bard nevertheless makes vague claims that the “context” within all of these is “clear” in 

that they are only for use in clinical studies. Id. at 14-15. 

The text of Reporting Standards is clear about their purpose. The Reporting 

Standards state that the reason behind the publication of these standards is due to the 

“increased interest in non-permanent vena cava filters, with both increased research and

clinical use of these devices.”14 Nowhere do any of the standards state that they are only

to be used in research. In fact, Dr. Morris himself asserted that use of these reporting 

standards explicitly for clinical studies was “just ... one of the ways to interpret ... the 

meaning of [these standards]. Morris Dep. at 264:1-8. Thus, Dr. Morris clearly 

contradicts himself when he claims in his reports that no authoritative society or 

organization recommends imaging as part of a surveillance or medical monitoring 

program. See Ex. 3, MDL Rep. 16; Ex. 1, Class Rep. 17. Such a contradiction, about a 

fundamentally important piece of literature, calls into question Dr. Morris’s basis for his 

opinion that imaging should not be part of a follow-up or monitoring program. 

Bard nonsensically argues that the Reporting Standards only specify using 

imaging for permanent filters. Br. at 15-16. The earlier 1999 and 2003 versions of the 

Reporting Standards specifically use the phrase “minimum objective testing” when 

recommending imaging of the filter during follow-up. Bard latches onto this language, 

arguing that the 1999 and 2003 versions of the standards are only applicable to permanent 

filters, and because this “minimum objective testing” quote is only in these earlier 

versions, SIR necessarily could not have meant that imaging would be recommended for 

follow-up of Bard retrievable filters. Br. at 15-16. Although Bard retrievable filters were 

not on the market in 1999, the Bard Recovery filter was certainly on the market with a 

retrievability indication when the 2003 Reporting Standards were published. 

14 See, e.g., Ex. 19, Steven F. Millward FRCPC et al., Reporting Standards for Inferior 

Vena Caval Filter Placement and Patient Follow-up: Supplement for Temporary and 

Retrievable/Optional Filters, 16 J. Vasc. Interv. Radiol. 441, 441 (2005). 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 12 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 12 - 

Furthermore, the 2003 Reporting Standards do in fact contain sections specifically 

addressing “Temporary and Optional Filters” which urge that follow-up assessment for 

optional filters be performed according to the general recommendations for all filters, 

including the same “minimum objective testing.”15 The 2003 standards also recommend 

that follow-up assessments consider “Additional Reporting Criteria for Temporary and 

Optional Filters” which specify additional procedures for retrievable filters such as 

determining complications during removal.16 It is plainly wrong for Bard to suggest that 

these guidelines are only for permanent filters and that imaging is not recommended for 

retrievable filters. 

Bard also incorrectly suggests that because the Reporting Standards contain 

references to recording data in clinical studies, it necessarily means that the follow-up 

recommendations are not to be used as guidance for practicing physicians. Br. at 16-17. 

It is indisputable that Bard itself cites these Reporting Standards as references in its own 

IFUs when suggesting that follow-up is necessary for its retrievable IVC filters. For 

example, the Bard Denali IFU states: “Standards and guidelines developed by the 

Society of Interventional Radiologists recommend that patients with filters (either 

permanent or retrievable) be tracked and receive ‘routine follow-up’ subsequent to the 

placement of the device.” Ex. 17 at 3, Bard Denali IFU. Bard then cites directly to both 

the 2003 and 2005 Reporting Standards, both of which recommend that imaging be used 

during follow-up. Id. Dr. Morris’s failure to recognize Bards own IFU 

recommendations, along with his unwillingness to acknowledge literature recommending 

that imaging should be used during follow-up, render his opinions unreliable and 

therefore his opinions should be excluded. 

 

15 Ex. 18, The Participants in the Vena Caval Filter Consensus Conference, 

Recommended Reporting Standards for Vena Caval Filter Placement and Patient 

Follow-Up, 14 J. Vasc. Interv. Radiol. 427, 429 (2003) (“Reports for [optional] devices 

should include all the information listed above and also those factors particular to these 

devices (Table 6).”). 

16 Id.

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 13 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 13 - 

2. Bard Mischaracterizes the Literature. 

In their opening brief, Plaintiffs showed that Dr. Morris subjectively disregarded 

certain important articles when making his opinions, including articles by Duffett and 

Kuo. See Ex. 4, Morris Dep. at 171:9-172:20; 188:13-189:17; 191:21-192:24. In 

response, Bard argues that those articles support Dr. Morris’s opinions that medical 

imaging is not needed in a patient follow-up program for the purpose of finding 

complications, Br. 17-19, but misinterprets those articles. 

For instance, Bard cites Duffett, et al., arguing that this article supports 

Dr. Morris’s opinion that imaging should only be used during follow-up of IVC filter 

patients if their complications are symptomatic. Br. 17-18. Bard’s suggestion misreads 

the article. The Duffett article explains that a “growing body of evidence ... suggests that 

IVC filters are frequently associated with clinically important adverse events, prompting 

a closer look at their role.”17 Duffett recommends that screening these complications is 

necessary for all patients, though certain methods of screening may be more ideal in 

finding different types of filter complications.18 Hence, if a complication symptom does 

develop, then that symptom may indicate that a particular type of screening may be more 

ideal for viewing that particular type of complication. In any event, Duffett 

unequivocally states that “[i]n patients where an IVC filter remains, regular follow-up to 

reassess removal and screen for filter-related complications should occur.”19

Bard also cites Kuo, et al.,20 suggesting that IVC filter patients should be clinically 

assessed only to determine whether they continue to need IVC filtration, not to check the 

status of the filter. Br. at 18. This is a misnomer. Kuo states that “The risk of filter 

fracture increases after 408 days ... of implantation and is associated with symptomatic 

 

17 Ex. 21, L. Duffett, MD, Inferior Vena Cava Filters, 15 J. Thrombosis & Haemostasis 

3, 3 (2017). 

18 Id. at 7-9. 

19 Id. at 3. 

20 Ex. 22, William T. Kuo, MD et al., Complex Retrieval of Fractured, Embedded, and 

Penetrating Inferior Vena Cava Filters: A Prospective Study with Histologic and 

Electron Microscopic Analysis, 24 J. Vasc. Interv. Radiol. 622 (May 2013). 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 14 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 14 - 

extravascular penetration and/or intravascular embolization.”21 Kuo does not state that 

all complications are symptomatic, but nevertheless states that all patients who have 

received Bard IVC filters “should be evaluated for prompt filter removal if clinically 

indicated ... or they should at least be closely monitored for complications that could 

then be treated at centers with appropriate expertise.”22 Thus, Kuo suggests that even if a 

filter is not yet being removed, and even if there are no symptoms present, the ever 

increasing risks of indwell Bard IVC filters necessitate checking the filter’s status.23

Neither Duffett nor Kuo support Dr. Morris’s opinions that imaging is not 

necessary to check the status of the filter or to assist in finding potential complications in 

asymptomatic patients. These studies, along with a number of other bodies of medical 

literature, recognize the ever increasing risk of implanted Bard IVC filters and 

recommend imaging and follow-up specifically to find complications and protect 

patients. Dr. Morris selectively ignored all of these studies in forming his opinions which 

implore the use of screening to diagnose complications, and therefore his opinions should 

be excluded. 

III. CONCLUSION 

For the reasons set forth above, Plaintiffs respectfully request that the Court grant 

Plaintiffs’ motion to exclude the opinions and testimony of Christopher S. Morris, M.D. 

 RESPECTFULLY SUBMITTED this 18th day of October, 2017. 

 GALLAGHER & KENNEDY, P.A. 

By:/s/ Mark S. O’Connor 

Mark S. O’Connor 

Paul L. Stoller 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

 

21 Id. at 622. 

22 Id. at 629-30. 

23 Id. at 622. 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 15 of 16
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

1372803.3 - 15 - 

 LOPEZ McHUGH LLP

Ramon Rossi Lopez (CA Bar No. 86361) 

(admitted pro hac vice) 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

Co-Lead/Liaison Counsel for Plaintiffs

CERTIFICATE OF SERVICE 

I hereby certify that on this 18th day of October, 2017, I electronically transmitted 

the attached document to the Clerk’s Office using the CM/ECF System for filing and 

transmittal of a Notice of Electronic Filing. 

/s/ Gay Mennuti 

Case 2:15-md-02641-DGC Document 8210 Filed 10/18/17 Page 16 of 16