REDACTED DOCUMENTS 

RELATED TO DOCKET 7953

7953 - Plaintiffs’ Controverting Statement of Facts in 

Opposition to Bard’s Motion for Partial Summary 

Judgement as to Plaintiffs Lisa and Mark Hyde’s 

Claims – Filed Redacted 

Exhibit A: Excerpts of 8/23/17 Deposition of Tim Hug;

Exhibit B: Selected Medical Records of Lisa Hyde;

Exhibit C: Excerpts of 4/6/17 Deposition of M.D.; and 

Exhibit D: Excerpts of 7/24/17 Deposition of Derek Muehrcke M.D.

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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

DISTRICT OF ARIZONA

In Re Bard IVC Filters Products 

Liability Litigation 

No. MD-15-02641-PHX-DGC

PLAINTIFFS’ CONTROVERTING 

STATEMENT OF FACTS IN 

OPPOSITION TO BARD’S MOTION 

FOR PARTIAL SUMMARY 

JUDGEMENT AS TO PLAINTIFFS LISA 

AND MARK HYDE’S CLAIMS 

LISA HYDE and MARK HYDE, a 

married couple, 

Plaintiffs, 

v. 

C.R. BARD, INC., a New Jersey 

corporation and BARD PERIPHERAL 

VASCULAR, an Arizona corporation, 

Defendants.

Plaintiffs submit this Controverting Statement of Facts in Support of Plaintiffs’ 

Response in Opposition to Defendants’ Motion for Summary Judgment as to Plaintiffs 

Lisa and Mark Hyde’s Claims. Plaintiffs respond to Bard’s Statement of Facts allegations 

as follows: 

1. On , Lisa Hyde 

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(Ex. A, Plaintiffs’ Fact Sheet (“PFS”) at § II.3.; Ex. B, Selected Plaintiff Medical Records 

at HYDEL_ MDR00099.) 

Admit. 

2. The Plaintiffs were Wisconsin residents at that time. (Ex. A, PFS at § I.5.) 

Plaintiffs admit that they were residents of Wisconsin in February of 2011. 

3. On , implanted a Bard IVC filter in Ms. 

Hyde at Wisconsin. (Ex. A, PFS, at 

§§ II.2(a), II.4, II.5.; Ex. B, Selected Plaintiff Medical Records at 

HYDEL_ _RAD00002 – HYDEL_ _RAD00003.) 

Admit. 

4. At the time of Ms. Hyde’s filter implant, was only practicing 

medicine in Wisconsin. (Ex. C, April 6, 2017 Deposition Transcript 

(“ Dep. Tr.”) at 4:23-5:2, 22:16-20.) 

Admit. 

5. Any contacts Bard had with would have occurred in Wisconsin 

through Bard’s Wisconsin-based sales representative, Matthew Fermanich. (Ex. D, March 

27, 2017 Matthew Fermanich Deposition Transcript at 17:1-18:19.) 

Admit in part; deny in part. Mr. Fermanich was one person representing 

Bard that had contacts with . But the deposition testimony cited by Bard 

does not establish Dr. Fermanich was the only contact. Moreover, Timothy Hug

testified that he as well had contacts with about Bard IVC filters, while a 

territory manager (sales representative) and district manager for Bard. [Ex. A, 

August 22, 2017 Timothy Hug Deposition Transcript at 43:3-45:11]. 

6. Nothing in the record indicates what, if any, changes occurred to the Bard 

filter from the time that it left Bard’s possession to the time that it was placed in Ms. 

Hyde.

Deny. There is no direct evidence of any changes having occurred to the Bard 

filter implanted in Lisa Hyde from the time that it left Bard’s possession to the time 

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that it was placed in Mrs. Hyde. Indeed, the record provides a strong and 

reasonable inference that there were not any changes in the Bard IVC filter. 

 has been an Interventional Radiologist with experience implanting IVC filters 

since the early 1990s. [Bard SOF Ex. C, at 9:12-10:18, 17:22-18: 9.] The records 

relating to his implant procedure for Mrs. Hyde indicate a normal 

placement of a Bard IVC filter; there is no mention of any perceived differences 

between Mrs. Hyde’s Bard IVC filter and others of its kind that has 

placed in other patients. [Ex. B, Selected Plaintiff Medical Records at 

HYDE_ _MDR00172.] A reasonable and prudent physician would have noted 

if there was and/or more than likely would have opted to use a different filter. 

7. testified that the Bard filter’s ability to “potentially be retrieved” 

was “definitely” one of the benefits that he considered in choosing the Bard filter for Ms. 

Hyde. (Ex. C, Dep. Tr. At 89:25-90:12.) 

Admit in part; deny in part. While it is true 

 [Bard SOF Ex. C, at 72:23-73:1.] 

8. In 2001, the Society of Interventional Radiology published the following 

clinical practice guidelines that reported about the complications of all IVC filters. (Ex. E, 

Grassi, Quality Improvement Guidelines for Percutaneous Permanent Inferior Vena Cava 

Filter Placement for the Prevention of Pulmonary Embolism, 12 J. Vascular & 

Interventional Radiology 137, 139 (2001).) 

Objection. This statement is vague and ambiguous as to “the following 

practice guidelines” and mischaracterizes the relied-upon document. Subject to said 

objection, Plaintiffs admit that the relied-upon document was published and 

reported on the complication rates involved with IVC filters. 

The relied-upon article is self-described as a document that “will provide 

quality improvement guidelines for filter placement within the inferior vena cava 

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because of the limited data available for implantation sites other than the IVC.” 

[Bard SOF Ex. E, at 137]. 

Additionally, the relied-upon document does not indicate which IVC filters 

were involved in the study. The document only states, “[c]omplication rates are

highly variable depending on the filter being studied. For simplicity, these guidelines 

will not suggest threshold rates for each individual filter; rather, filtration devices 

will be considered as a group (Table 1).” Id. at 139.

9. The Society of Interventional Radiology reported that IVC filters migrated 

(reported at rates up to 18%), fracture (reported at rates up to 10%), perforate the IVC 

(reported at rates up to 41%), and tilt (reported at rates from 5 to 50%). Id.

Admit.

10. In 2009, Binkert, et al. published a study in the Journal of Vascular and 

Interventional Radiology 2009 reporting on perforation, filter fracture, tilt, and migration 

with Bard’s filters. (Ex. F, Binkert, C.A., et al., Technical Success and Safety of Retrieval 

of the G2 Filter in a Prospective, Multicenter Study, J VASC. INTERV. RADIOL. 2009; 

20:1449-1453.)

Plaintiffs admit that the relied-upon document reported, among other things, 

on perforation, filter fracture, tilt, and migration with Bard’s G2 filter.

11. On August 9, 2010, the FDA issued a Safety Alert concerning all IVC 

filters. (Ex. G, Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse 

Events with Long Term Use.)

Admit.

12. The FDA wrote, “Known long term risks associated with IVC filters include 

but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter 

migration, filter embolization and IVC Perforation.” Id.

Admit.

13. Also in 2010, Dr. Nicholson, et al. authored a published article reporting on 

perforation, filter fracture, tilt, and migration with Bard’s filters. (Ex. H, Nicholson, et al., 

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Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava 

Filters and Clinical Implications Including Cardiac Perforation and Tamponade,” 

ARCHIVES OF INTERNAL MEDICINE, Vol. 170 No. 20, November 8, 2010.) 

Admit. 

14. testified that at the time of Ms. Hyde’s implant he was aware that 

IVC Filters in general could move, fracture, and that fractured components could 

embolize. (Exhibit C, Dep. Tr. At 85:17-86:2.) 

Admit. 

15. also testified that his criteria for choosing an IVC filter for Ms. 

Hyde was that it is cleared for use by the FDA, that he trusts the FDA more than 

individual manufacturers, and that he would not have altered his treatment of Ms. Hyde 

with a Bard IVC filter even if he was provided with certain facts the plaintiffs allege to be 

true. Id. at 25:13-25, 31:15-32:11, 44:20-45:24. 

Objection. Misstates evidence and incorrectly characterizes 

understanding of the FDA’s role and responsibility in terms of ensuring the safety 

and efficacy of medical devices that are cleared by the FDA via its 510(k) process. 

Plaintiff admits that testified several times that whether a device was 

“approved” by the FDA was paramount to his decision to use it with a patient. 

 never used the word “cleared” and did not indicate an understanding of the 

difference between the two. Rather, testified he does not understand 

“exactly how the FDA goes about their business.” [Bard SOF Ex. C, at 49:6-14]. 

Plaintiffs admit testified that he trusts the FDA more than individual 

companies. Plaintiffs further deny that testified that he would not have 

altered his treatment of Mrs. Hyde with a Bard IVC filter even if he was provided 

with certain facts Plaintiffs allege to be true; this is a mischaracterization or, at best, 

a self-serving prediction based on the cited language. Id. at 44:20-45:24. In terms of 

what he knew of the risks and benefits of the different IVC filters, further 

testified that he did not “see any deciphering thing to persuade me one way or the 

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other” regarding failure and complication rates of IVC filters. Id. at 47:2-15. This 

goes to the heart of Plaintiffs’ failure to warn claim – was not provided 

with complete and accurate information, and was disallowed by his attorney from 

reviewing other internal documents by Bard evidencing, among other things, the 

complications and rates of complications associated with the Bard IVC filters and 

whether such information would have impacted his decision to implant the Bard 

IVC filter in Mrs. Hyde in 2011. 

16. further testified that he did not recall any discussions with Bard’s 

sales representatives that occurred at any time before treating Ms. Hyde. Id. at 39:14-

40:8. 

Admit in part; deny in part. testified that he did not recall any 

discussions, but that he “probably did” meet with Bard sales representatives prior to 

2011. [Bard SOF Ex. C, at 39:14-40:8] 

17. The IVC filter implanted in Ms. Hyde was sold by Bard to 

Admit. 

18. The IVC filter implanted in Ms. Hyde is not sold directly to patients. (Ex. I, 

G2®X Instructions for use (the “G2X IFU”) at page 1; Ex. J, Eclipse® Filter Instructions 

for Use (the “Eclipse IFU”) at page 1.) 

Admit. 

19. The G2X and Eclipse® IFU applicable in (when the Plaintiff 

received her filter) included the following identical warnings: 

a. Under the bolded headings “Warnings” and “Potential 

Complications,” the IFUs warn of the following complications: 

• Filter fractures are a known complications of vena cava filters. There have 

been some reports of serious pulmonary and cardiac complications with vena 

cava filters requiring the retrieval of the fragment utilizing endovascular 

and/or surgical techniques. 

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• Movement, migration or tilt of the filter are known complications of vena

cava filters. There have also been reports of caudal migration of the filter.

Migration may be caused by placement in IVCs with diameters exceeding

the appropriate labeled dimensions specified in this IFU. Migration may also

be caused by improper deployment, deployment into clots, and/or

dislodgment due to large clot burdens.

(Ex. I, G2X IFU, Ex. J, Eclipse IFU.) 

Admit that Bard SOF Ex. I, G2X IFU and Ex. J, Eclipse IFU contain the 

quoted language. 

20. The “Potential Complications” of the IFUs also warn about “Filter tilt,”

“Filter malposition,” “Perforation or other acute or chronic damage of the IVC wall,” and 

“Vessel injury.” Id.

Admit. 

21. Finally, the IFUs also warn that “All of the above complications may be

associated with serious adverse events such as medical intervention and/or death.” 

Id.

Admit. 

22. The plaintiffs have not identified alternative warnings that would have

rendered Bard’s IVC filter safe. 

Deny. A reasonable alternative warning would feature all the information 

that Bard knew regarding its G2/G2X filters and their propensity to malfunction at a 

higher rate than other Bard filters and competitive filters, rather than the general 

warnings about all IVC filters included in the IFUs. testified that he may 

have been swayed by information indicating that Bard knew the filter implanted in 

Ms. Hyde was not performing as well as competitors’ IVC filters. [Ex. C, 

Dep. Tr. at 56:17-18.] 

23. The plaintiffs’ expert, Dr. Derek Muehrcke, acknowledges that all IVC

filters are known to have complications, including filter fracture, migration, tilt, 

penetration, and perforation. (Ex. K, July 24, 2017 Dr. Derek Muehrcke Deposition 

Transcript at 55:22-57:9.) 

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Admit in part; deny in part. Admit that Dr. Muehrcke acknowledged that all 

IVC filters can have complications, but deny that this is the overall position he takes 

with regard to complications of IVC filters. Dr. Muehrcke testified that some filters 

are much less likely to have the potential complication of tilt. [Ex. D, Muehrcke Dep. 

Tr. at 56:12-16.] Dr. Muehrcke also testified that the Bard G2 filter had an 

unacceptable caudal migration risk that Bard had been aware of since late 2005, 

early 2006, resulting in an unacceptable safety profile for the G2 filter. [Ex. D, 

Muehrcke Dep. Tr. at 57:10-20]. Finally, Dr. Muehrcke testified that particularly as 

to Bard filters, their benefit does not outweigh their risk and that he does not use 

Bard filters anymore because he thinks that their complication rates “are just too 

high.” To a reasonable degree of medical certainty, Dr. Muehrcke differentiates the 

complication rates of non-Bard filters and testified that the Bard filters were a 

higher risk than benefit when implanted. [Ex. D, Muerhcke Dep. Tr. at 188:14-189: 

20.] 

24. Bard is not aware of any IVC filter manufacturer that provides comparative

rates in the instructions for use that it provides to doctors. 

Objection. Bard cites to no evidence to support this statement. Also, the 

statement is immaterial and self-serving of the company’s state of mind; it is not a 

fact that can be denied of admitted. Denied for the reasons so stated. 

25. Bard’s G2X and Eclipse IVC filters were cleared for use by the FDA

through its 510(k) process. (Ex. L, FDA Clearance Letter for G2X IVC filter, Ex. M, FDA 

Clearance letter for Eclipse IVC filter.) 

Admit. 

26. As part of Bard’s compliance with the FDA’s 510(k) process, Bard

submitted proposed warnings for the G2X and Eclipse filters, which were approved by the 

FDA as part of the FDA’s clearance of the devices. (See Exhibit 104 to Robert Carr’s 

Declaration in Support of Bard’s Motion for Summary Judgement Regarding Preemption 

at BPV-17-01-130627 – BPV-17-01-130660, lodged under seal at docket no. 5411; 

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Exhibit 121 to Robert Carr’s Declaration in Support of Bard’s Motion for Summary 

Judgement Regarding Preemption at BPV-17-01-00117076 – BPV-17-01-00117095, 

lodged under seal at docket no. 5411.) 

Admit. 

27. Neither of the plaintiffs have ever spoken to anyone at Bard or received any

information from Bard. (Ex. N, January 25, 2017 Lisa Hyde Deposition Transcript (“Lisa 

Hyde Dep. Tr.”) at 140:13-22; Ex. O, January 25, 2017 Mark Hyde Deposition Transcript 

at 48:22-49:1.) 

Admit. 

28. On , while the plaintiffs were residents of Nevada, Ms. Hyde 

first learned that her IVC filter (Ex. A, PFS at I.5, II.12(iii).) 

Admit. 

29. The plaintiffs have not identified a reasonable alternative design to Bard’s

IVC filter that would have reduced or avoided risks of harm that Ms. Hyde experienced 

while also retaining the option of percutaneous retrieval. 

Deny. Plaintiffs have evidence by way of expert testimony, Bard corporate 

witness testimony, and have even pointed to the obvious notion that the predicate 

device of Bard’s Recovery/G2 line of filters – the SNF – was indeed a safer 

alternative design. Moreover, at least one other manufacturer of IVC filters had 

redesigned its filter in 2006 to include an anchoring system to help prevent caudal 

migration. See Plaintiffs’ Omnibus Statement of Facts, filed contemporaneously, 

Exhibit 86. This, too, is evidence of another safer alternative design. 

30. The plaintiffs moved from Wisconsin to Nevada

. (Ex. N, Lisa Hyde Dep. Tr. At 18:20-19:2.) 

Admit. 

31.

. (Ex. A, PFS at II.10(a)-(c).) 

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Admit in part; deny in part. Objection to the extent the statement incorrectly 

characterizes the Mrs. Hyde. 

 [Ex. B, 

Selected Plaintiff’s Medical Records, at HYDEL_ _MDR00035, 42, 53-56.] 

32. The plaintiffs’ expert, Robert M. McMeeking, Ph.D., acknowledges that the 

Simon Nitinol Filter does not represent a reasonable alternative design to Bard’s 

retrievable IVC filters. (Ex. P, July 6, 2017 Robert M. McMeeking, Ph.D. Deposition 

Transcript at 221:16-223:3.) 

Deny. Dr. McMeeking testified that the Simon Nitinol Filter is a safer 

alternative design to the Recovery and its successors. (Bard’s SOF Ex. P, July 6, 

2017 at 221:20-24). 

RESPECTFULLY SUBMITTED this 2nd day of October 2017. 

GALLAGHER & KENNEDY, P.A. 

By: /s/ Mark S. O’Connor 

Mark S. O’Connor (011029) 

2575 East Camelback Road

Phoenix, Arizona 85016-9225 

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 

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CERTIFICATE OF SERVICE

I hereby certify that on this 2nd 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/ Deborah Yanazzo 

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 12 of 126
EXHIBIT A

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7953

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 13 of 126
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 1

 1 UNITED STATES DISTRICT COURT

 2 DISTRICT OF ARIZONA

 3

 4

 5

 In Re Bard IVC Filters Products

 6 Liability Litigation No.

 MD-15-02641-PHX-DGC

 7

 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

 8

 9

 10 Do Not Disclose

 11 Subject to Further Confidentiality Review

 12

 VIDEOTAPED DEPOSITION OF

 13

 TIM HUG

 14

 15 AUGUST 23, 2017

 16 10:00 a.m.

 17

 18

 2575 East Camelback Road, 11th Floor

 19

 Phoenix, Arizona

 20

 21

 22

 SOMMER E. GREENE, CSR, RPR, CR No. 50622

 23

 24

 25

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 14 of 126
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 43

 1 Q. -- in Franklin, Wisconsin?

 2 A. Yes, sir.

 3 Q. Do you know Dr. who -- well, he was

 4 privileged at that hospital in 2010, 2011.

 5 A. I do know Dr. .

 6 Q. You met with him before?

 7 A. I have.

 8 Q. Do you have a relationship with him?

 9 A. Business relationship.

 10 Q. When was the first time you met Dr. ?

 11 A. My assumption is is that it was in 2007 -- 2007

 12 as his territory sales representative.

 13 Q. Do you recall ever speaking with him about IVC

 14 filters?

 15 A. I can't recall a specific instance, but I'm

 16 sure I have.

 17 Q. Was -- excuse me. Were IVC filters one of the

 18 products you were tasked with promoting and trying to

 19 sell in 2007?

 20 A. Yes, sir.

 21 Q. So the likelihood is that you probably did

 22 speak with them about IVC filters?

 23 A. Yes, sir.

 24 Q. And they purchased G2 filters from Bard.

 25 Correct?

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 15 of 126
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 44

 1 A. I believe they did. I'd have to look at the

 2 specific sales numbers, but I believe so. They used Bard

 3 filters there, if that answers your question.

 4 Q. Do you know how many times you met with

 5 Dr. Henry?

 6 A. This is an assumption. My assumption is

 7 probably anywhere from five to 15 times.

 8 Q. Ever?

 9 A. Yeah.

 10 Q. Okay.

 11 A. Actually, let me clarify. It's probably more

 12 than that. Probably 10 to 20 times.

 13 Q. Okay. When was the last time you saw him, if

 14 you recall?

 15 A. It's been awhile.

 16 Q. Or spoken to him?

 17 A. Probably five years.

 18 Q. Do you know --

 19 A. Five years plus.

 20 Q. Do you recall in what capacity or why you spoke

 21 with him five years ago?

 22 A. I can't recall the actual interaction with him.

 23 I believe it was at the SIR meeting, which is a societal

 24 meeting for interventional radiologists. I believe

 25 that's where I saw him, but I would have to -- but I

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 16 of 126
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 45

 1 can't specifically recall.

 2 Q. Did you educate Dr. Henry on the G2 filter?

 3 MR. LERNER: Objection to form.

 4 THE WITNESS: In the sense of, yes,

 5 communicating and discussing the filters with him, yes.

 6 Q. BY MR. LOPEZ: You talk with him about the

 7 risks and benefits associated with the G2 filter?

 8 A. Yes, sir.

 9 Q. And that information is information you

 10 obtained from Bard. Correct?

 11 A. Correct, sir.

 12 Q. Bard would give you the information or

 13 materials that you would use to do your job to try to

 14 sell or along the lines of selling to educate the

 15 physicians on how to use products and why they should use

 16 Bard products?

 17 A. Yes, sir.

 18 Q. So as a district manager, your primary job was

 19 to basically monitor the sales reps that worked for you

 20 and make sure that they're reaching quotas, sales quotas?

 21 A. Yeah, you could summarize that. I mean, my --

 22 I would say it a little bit differently, but, yes, I

 23 would agree with kind of your description there.

 24 Q. And you track their performance. Right? You

 25 monitor closely what they're doing day in and day out?

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 17 of 126
EXHIBIT B 

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7953

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 18 of 126
97 of 290 

HYDEL WFHF MDR00099 

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98 of 290 

HYDEL WFHF MDROOlOO 

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99 of 290 

HYDEL WFHF MDR00101 

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167 of 290 

HYDEL WFHF MDR00169 

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168 of 290 

HYDEL WFHF MDR00170 

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HYDEL WFHF MDR00118 

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170 of 290 

HYDEL WFHF MDR00172 

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171 of 290 

HYDEL WFHF MDR00173 

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~03 of 290 

HYDEL WFHF MDR00105 

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104 of 290 

HYDEL WFHF MDR00106 

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105 of 290 

HYDEL WFHF MDR00107 

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81 of 290 

HYDEL WFHF MDR00083 

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HYDEL WFHF MDR00084 

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HYDEL WFHF MDR00057 

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HYDEL WFHF MDR00029 

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HYDEL WFHF MDR00030 

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HYDEL WFHF MDR00031 

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HYDEL WFHF MDR00042 

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HYDEL SLEHR MDR00088 

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HYDEL SLEHR MDR00089 

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HYDEL SLEHR MDR00091 

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HYDEL SHC MDR00037 

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HYDEL SHC MDR00038 

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HYDEL SHC MDR00040 

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HYDEL SHC MDROOOlO 

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HYDEL SHC MDROOOll 

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HYDEL SHC MDR00012 - -

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HYDEL SHC MDR00017 

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HYDEL SHC MDR00213 

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HYDEL SHC MDR00054 

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HYDEL SHC MDR00061 - -

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HYDEL SHC MDR00062 - -

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HYDEL SLEHR MDR00093 

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HYDEL SLEHR MDR00094 

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HYDEL SLEHR MDR00095 

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HYDEL SLEHR MDR00096 

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EXHIBIT C 

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7953

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 109 of 126
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 1

 1 UNITED STATES DISTRICT COURT

 2 DISTRICT OF ARIZONA

 3 * * * * * * * * * * * * * * *

 4

 In Re Bard IVC Filters Products

 5 Liability Litigation

 6 No. MD-15-02641-PHX-DGC

 7

 8

 * * * * * * * * * * * * * * *

 9

 10 DO NOT DISCLOSE - SUBJECT TO FURTHER

 CONFIDENTIALITY REVIEW

 11

 VIDEOTAPED DEPOSITION OF , M.D.

 12

 TAKEN AT: Leib Knott Gaynor

 13 LOCATED AT: 219 North Milwaukee Street

 Milwaukee, WI

 14

 April 6, 2017

 15 10:07 a.m. to 12:28 p.m.

 16 REPORTED BY ANITA K. FOSS

 REGISTERED PROFESSIONAL REPORTER

 17

 18

 19

 * * * * * * * * * * * * * * *

 20

 21

 22

 23

 24

 25

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 110 of 126
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Golkow Technologies, Inc. Page 65

 1 answer any of my questions. Who referred 

 2 to you?

 3 A. I do not recall.

 4 Q. Are you able to determine from the

 5 records?

 6 A. It may have been 

 7 Q. Do you recall the reason for your

 8 consult?

 9 A. I do not recall, but this implies that

 10 she had -- she had 

 .

 12 Q. What I want to do is go through your

 13 understanding of the patient's history and your

 14 thought process for the treatment you recommended.

 15 And I want to give you the freedom to do that in a

 16 way that is easiest for you with the records and

 17 your memory. So could you explain to this jury

 18 your understanding of the patient's history? We'll

 19 start with that.

 20 A. Yeah. "The patient is a 

 

 

 

 

 This also happened to

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Golkow Technologies, Inc. Page 11

 1 interventional radiology procedures during that 13

 2 to 14 years in Ohio?

 3 A. Yes.

 4 Q. About what percentage or practice, while

 5 you were in Ohio for those 14 years, was

 6 interventional radiology as opposed to general

 7 radiology?

 8 A. Maybe 25 percent, 30 percent.

 9 Q. Did that include implanting IVC filters?

 10 A. Yes.

 11 Q. Now, do you recall a patient of yours, my

 12 client, ?

 13 A. I do not.

 14 Q. Have you had an opportunity to review any

 15 medical records to refresh your recollection about

 16 that patient?

 17 A. I was here yesterday and I had -- I

 18 reviewed a one -- my -- I think my -- my report of

 19 the procedure.

 20 Q. That procedure was what?

 21 A. 

 22 Q. 

 23 A. I believe it may have been, but I'm not

 24 sure.

 25 Q. Was that procedure -- or did that

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Golkow Technologies, Inc. Page 46

 1 Q. Sure. Understanding that you have some

 2 more trust of the FDA than individual companies, if

 3 you actually learned that the complication rates

 4 among filters was not equivalent, even though they

 5 had all been cleared, that's the type of

 6 information, as a treating doctor, you would have

 7 been interested in and considered -- at least

 8 considered when making your treatment decisions?

 9 MR. LEIB: Well --

 10 MS. DALY: Objection. Same objection as

 11 before, leading, and now it's argumentative.

 12 MR. LEIB: It's -- it's clearly a

 13 hypothetical, but I think unless it's tethered to

 14 this patient, it is invading the privilege. So I

 15 would invite you to rephrase it to tether it this

 16 to patient.

 17 BY MR. SAELTZER:

 18 Q. And I had intended to mean that's the

 19 type of information you would have considered in

 20 making your treatment decision for 

 21 MR. LEIB: Okay. If you know that, you

 22 can say yes. And if you don't know, you say you

 23 don't know. If you have to speculate -- he doesn't

 24 want you to guess at any of these answers.

 25 THE WITNESS: Yeah, I don't know.

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Golkow Technologies, Inc. Page 56

 1 that would have been something he would have

 2 factored into his clinical judgment.

 3 MR. LEIB: You've tethered it to the

 4 article, that's the problem. The form of the

 5 question invades his privilege, and that's why I'm

 6 instructing him not to answer.

 7 BY MR. SAELTZER:

 8 Q. If Bard knew that 

 

 and it knew

 11 that before , is that the type of

 12 information you would have considered if Bard had

 13 brought that to your attention?

 14 MS. DALY: Same objection.

 15 THE WITNESS: I don't particularly pay

 16 attention to everything that's published or comes

 17 my way. And so if I had read the article, I -- I

 18 may or may not have been swayed by its contents.

 19 BY MR. SAELTZER:

 20 Q. At the time you 

 did you believe that 

 

 

 24 A. No.

 25 Q. At the time you i

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Golkow Technologies, Inc. Page 72

 1 in addition to the medication?

 2 A. Well, we're not always certain how the

 3 body will react to blood thinning medication. And

 4 if the patient has a pattern of -- of getting

 5 clots, there's concern that one more clot could --

 6 could be devastating. You err on the side of

 7 caution, and you want to make sure that somehow the

 8 patient is protected. And henceforth the notion of

 9 a filter would serve that purpose.

 10 Q. Somewhat of a belt-and-suspenders

 11 approach here with the medicine and the filter?

 12 A. Yes.

 13 Q. Getting to the type of filter and your

 14 discussions with the patient. Did you have any

 15 plan or follow-up that you implemented at the time

 16 you saw for her to return so that she

 17 could b

 18 A. Yes. I said to her -- or I may have

 19 said; I don't recall specifically speaking to

 20 her -- but in the patients that I 

 I usually say to them, depending upon

 22 how you do over the interim and many other factors,

 23 that there's the potential that this 

 

 25 Q. It could be either?

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Golkow Technologies, Inc. Page 25

 1 Q. And then you also apply your knowledge as

 2 to what possible procedures or devices are

 3 available to treat that condition; right?

 4 A. Yes.

 5 MS. DALY: Objection. Objection,

 6 leading.

 7 BY MR. SAELTZER:

 8 Q. And Doctor, in coming and exercising your

 9 clinical discretion, do you perform a risk-benefit

 10 analysis?

 11 A. I get an informed consent, which includes

 12 risks, benefits, and alternatives.

 13 Q. When you are choosing which IVC filter to

 14 implant in a patient, can you describe for me what

 15 thought process you go to as to which filter you

 16 select from the various options that are out there

 17 in the marketplace?

 18 MR. LEIB: We're talking about in or

 19 around as a custom and practice pertaining to

 20 your client, 

 21 MR. SAELTZER: Yes, in and around

 22 February of 2011.

 23 THE WITNESS: I look for any filter

 24 that's FDA approved, that I'm familiar with

 25 placing.

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Golkow Technologies, Inc. Page 45

 1 MS. DALY: Same objections.

 2 MR. LEIB: He doesn't want you to

 3 speculate. If you have to guess, you have to tell

 4 him. If you -- based upon the information you've

 5 been given, if you can state , you can

 6 go ahead and historically tell him that.

 7 THE WITNESS: Right or wrong, I felt that

 8 the risks for all of the FDA-approvable devices

 9 were -- were reasonable and customary, and that I

 10 probably wouldn't have deferred or postponed the

 11 filter placement in a patient who I felt really

 12 needed it.

 13 BY MR. SAELTZER:

 14 Q. As I'm understanding your answer, right

 15 or wrong, you assumed that the complication rates

 16 among the FDA cleared or approved IVC filters was

 17 roughly equivalent?

 18 A. Yes.

 19 Q. If you had learned differently, that

 20 would be the type of information that you would

 21 have used in your clinical practice, true?

 22 MS. DALY: Same objections.

 23 THE WITNESS: I tend to trust the FDA

 24 more than individual companies.

 25 BY MR. SAELTZER:

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Golkow Technologies, Inc. Page 27

 1 custom and practice at the time that he 

 -- client. So I didn't

 3 view it as invading privilege. It was historical

 4 as to his thought process. So that's why I didn't

 5 assert a privilege, and I wouldn't instruct him.

 6 MS. DALY: I'm sorry, just again note my

 7 objection.

 8 MR. LEIB: Yeah, okay. And Taylor, I

 9 just didn't want to -- the reason why I asked you

 10 to elaborate because I -- you know, I assume that

 11 you're going to be asking some questions, and I

 12 want to be, as I say, evenhanded as to asserting

 13 the privilege to make sure that I understand what

 14 your objection is so if other objections come down

 15 the pike during your questioning, you know, I'll

 16 instruct him evenly between both parties.

 17 MS. DALY: Thank you.

 18 BY MR. SAELTZER:

 19 Q. Do you have the question in mind, Doctor?

 20 Would you like it read back to you?

 21 A. I'm sorry, what am I being asked?

 22 Q. That tells me we should probably read you

 23 the question. So we'll have the question read to

 24 you, Doctor.

 25 COURT REPORTER: "

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 118 of 126
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Golkow Technologies, Inc. Page 28

 1 , was it your understanding that all

 2 FDA-cleared IVC filters had the same performance?

 3 They all performed the same?"

 4 THE WITNESS: I think that they -- they

 5 were -- they were all very comparable.

 6 BY MR. SAELTZER:

 7 Q. Did you believe that they were all

 8 comparable in terms of risk of complications, such

 9 as migrations or fractures?

 10 A. Yes.

 11 Q. Doctor, going back to your state of mind

 12 in 2011 when you were making the decision about

 13 if an IVC

 14 filter carried with it a significant potential for

 15 serious injury or death, that would be important

 16 information for you to know as a clinician?

 17 MR. LEIB: Yeah, and I think that does

 18 call for an expert opinion, and I would instruct

 19 him not to answer. And I would invite you to

 20 re-frame the question to avoid invading the

 21 privilege and --

 22 MS. DALY: Join in the objection.

 23 BY MR. SAELTZER:

 24 Q. So Doctor, I want to go -- again, we'll

 25 go back, we time travel back to your thought

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Golkow Technologies, Inc. Page 86

 1 is that true?

 2 A. Yes.

 3 Q. Did you ever have an opportunity to read

 4 the instructions for use document that accompanied

 5 

 

 7 A. Yes.

 8 Q. Are you aware that the IFU, or the

 9 instructions for use for that filter, lists, among

 10 the complications that -- that may occur, fracture,

 11 movement, and perforation of the filter?

 12 A. Could you repeat the first part of the

 13 question? Am I --

 14 Q. Yes. Are you aware that the instructions

 15 for use includes a section on complications that

 16 one might experience with a Bard G2X filter?

 17 A. Yes.

 18 Q. And that that -- those precautions

 19 included what we just talked about with

 20 complications, which would be fracture, movement of

 21 the filter, embolization of filter fragment pieces?

 22 A. Yes.

 23 Q. And also that the filter can perforate;

 24 correct?

 25 MR. LEIB: The question is --

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EXHIBIT D

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7953

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 121 of 126
Page 1

 IN THE UNITED STATES DISTRICT COURT

 FOR THE DISTRICT OF ARIZONA

 NO. MD-15-92641-PHX-DGC

In re Bard IVC Filters Products

Liability Litigation

 Videotaped Deposition of DEREK D. MUEHRCKE, M.D.,

taken on behalf of defendant herein, pursuant to Notice

of Taking Deposition, at 32 Avienda Menendez St., St.

Augustine, St. Johns County, Florida, on July 24, 2017,

at 9:00 a.m., before Terry T. Hurley, Registered

Professional Reporter, and Notary Public in and for the

State of Florida at Large.

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 122 of 126
Page 56

1 yes.

2 Q That would include migration?

3 MR. O'CONNOR: Form.

4 A Well, I think that there's rates of migration,

5 but they can -- they can migrate.

6 Q All filters can migrate; correct?

7 MR. O'CONNOR: Form.

8 A There are -- all filters can migrate, yes.

9 Q And all filters have the potential complication

10 of fracture?

11 A Yes. That's true.

12 Q And all filters have the potential complication

13 of tilt?

14 MR. O'CONNOR: Okay.

15 A Correct. Some are much less likely, the

16 TrapEase, OptEase, but all can tilt.

17 Q What's the difference, if any, between the

18 words penetration and perforation with regard to

19 filters?

20 A That's a nuance for the radiologist to kind of

21 get into. I think -- to a certain extent, to me they're

22 synonymous, but I think they prefer the word penetration

23 as opposed to perforation. Perforation, one of the BARD

24 defense experts felt was a kind of a pejorative term

25 implying that things were going to leak out all over the

Case 2:15-md-02641-DGC Document 8385-5 Filed 10/24/17 Page 123 of 126
Page 57

1 place. And I think that the radiologists prefer

2 penetration as opposed to perforation.

3 I think it's a distinction without a difference

4 in my mind, but whatever.

5 Q Would you agree that all filters carry the risk

6 of penetration --

7 MR. O'CONNOR: Form.

8 Q -- or perforation?

9 A Yes.

10 Q Looking at the report, page 7,

11 paragraph 2, you said: At the time 

 BARD had been aware

13 since late 2005, early 2006 of the need to correct the

14 unacceptable caudal migration risk with the G2 filter.

15 Is that correct?

16 A That's correct.

17 Q And would you agree that all filters have the

18 potential to caudally migrate?

19 A I believe that there was an unacceptable safety

20 profile for the -- for the G2 filter.

21 MR. O'CONNOR: Move to strike as nonresponsive.

22 Q My question was, do you agree that all filters

23 have the potential to caudally migrate?

24 A All filters can migrate caudally.

25 MR. O'CONNOR: Late objection to the form of

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Page 188

1 Q Dr. Muehrcke, let me just follow up on a point

2 so we're clear.

3 Now, earlier in this deposition you were asked

4 I think questions about these five Bellwether plaintiffs

5 and whether the benefit of in these

6 patients outweighed the risks.

7 Do you recall that?

8 A Yes.

9 Q But is it your opinion that for these five

10 Bellwether plaintiffs that there were benefits of the

11 BARD filters they received which outweighed the risks?

12 MR. NORTH: Objection to the form, leading and

13 asking him to contradict previous testimony.

14 A No, I don't think that the benefits outweighed

15 the risk for BARD filters, because I don't use them

16 anymore.

17 Q Okay. And to that point, is that a

18 contradiction to your prior testimony?

19 MR. NORTH: Objection to form.

20 A My understanding is that we're talking about

21 filters in general, but -- but -- I don't -- I don't

22 think -- I don't use BARD filters, as I stated earlier

23 in the deposition, because I just don't -- I think the

24 complication rates are just too high.

25 Q And so when you talk about benefits outweigh

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Page 189

1 risks, is that in filters in general?

2 MR. NORTH: Objection to the form. Leading.

3 A Yes. In general, yes.

4 Q At the time of implant?

5 A At the time of implant, yes.

6 MR. NORTH: Same objection.

7 Q But is it your opinion these five Bellwether

8 patients received the benefits because they 

?

10 MR. NORTH: Objection to form. Leading.

11 A I -- I -- I don't use BARD filters because I

12 think that they are -- have a high complication rate.

13 Q And so in terms of your opinion about benefits

14 and risk for these five Bellwether plaintiffs, what is

15 your opinion?

16 A I think that the BARD filters were a higher

17 risk than a benefit when they were implanted.

18 Q Is that an opinion you hold to a reasonable

19 degree of medical certainty?

20 A Yes.

21 MR. O'CONNOR: That's all I have.

22 MR. NORTH: I'm just going to let the record

23 speak for itself as to the contradiction, so I have

24 no further questions.

25 THE VIDEOGRAPHER: This is the end of Disk 3,

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