REDACTED DOCUMENTS 

RELATED TO DOCKET 7946

7946 - Plaintiffs’ Controverting Statement of Facts in 

Opposition to Bard’s Motion for Partial Summary 

Judgement as to Debra Mulkey

REDACTED EXHIBITS:

Exhibit A: Selected Medical Records of Debra Mulkey;

Exhibit B: Expert Report of Darren Hurst, M.D.;

Exhibit C: Excerpts of 4/11/17 Deposition of , M.D.;

Exhibit D: Excerpts of 2/8/17 Deposition of Debra Mulkey; and

Exhibit E: Debra Mulkey Fact Sheet

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 1 of 129
EXHIBIT A 

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7946

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 2 of 129
Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 3 of 129
EXHIBIT B

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7946

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 4 of 129
Expert Report 

Debra Mulkey v. CR Bard Inc. 

Darren R. Hurst, M. D. 

Director Vascular and Interventional Radiology 

Department of Radiology 

l pg. 1 

L __ , 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 5 of 129
r---------~-----------·----

1 

I 

Table of Contents 

1. Introduction and Qualifications 

2. Materials reviewed 

3. Case Summary and Background 

4. Opinions 

Appendices 

a . Bard Materials and Depositions Reviewed 

b. Literature Reviewed 

c. CV 

d. Prior Testimony 2014-2017 

e. Billing Rates 

pg. 2 

------·------··~ --~-· --~-----

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 6 of 129
e is Darren R. Hurst. I am a full time physician and f ello::;--

l trained vascular and interventional radiologist. The discipline of 

l vascular and interventional radiology involves the diagnosis, treatment l and management of medical diseases and health conditions through 

imaging and targeted, image-guided, minimally invasive surgical 

procedures. The procedures I perform involve the introduction of 

medical devices into the human body under image guidance such as 

ultrasound, CT, and fluoroscopy. Often, this involves the use of needles, 

guidewires, catheters, balloons, stents, drains, and other medical 

devices. My education, training, and experience are detailed in my CV 

which is in appendix A of this report. My practice is located in 

Edgewood, Kentucky, and serves the Greater Cincinnati, Ohio area . I am 

familiar with the issues, subject matter, and topics involved in this 

litigation. I have personal experience with the use of both permanent 

and retrievable inferior vena cava filters for the prevention of pulmonary 

embolism. As part of my practice, I regularly implant and retrieve 

inferior vena cava filters. I am familiar with the relevant medical 

literature that addresses the issues concerning IVC filters, including, but 

not limited to, the indications and contraindications for use, placement, 

complications, and risks and benefits of the devices. I am also familiar 

with and have utilized multiple different types of filter devices including 

the Bard Simon Nitinol Filter®, Recovery Filter®, G2 Filter®, G2X 

Filter®, Eclipse® and Denali Filter®. This experience, in combination 

with my education and training in the field of medicine, and specifically, 

the field of Vascular and Interventional Radiology, has formed the basis 

for my opinions rendered in this litigation. 

2. Case Specific Materials Reviewed 

a. Medical Records: 

pg, 3 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 7 of 129
3. 

pg. 4 

vi. Dr. 2/2/ 12 - 5/23/ 13 

vu . Dr. 11/ 11/ 13 - 2/23/ 17 

b . Imaging Reviewed: 

c. Depositions: 

i. Debra Mulkey 2/8/ 17. 

11 . , M. D. 4/11 /17. 

111. , M.D. 3/28/ 17. 

1v. Scott Karch 3/20/17 

d . IFU 

i. Bard Eclipse and Meridian Filters. 

e. Bard Documents and Depositions (See Appendix) 

f. Expert Reports 

i. Drs. Kinney, Roberts, and Kalva 

11 . Mark Eisenberg, M. D. . 

iii. I have reviewed these reports, I agree with them, and I adopt 

the opinions and bases for those opinions set forth th erein. 

.-J 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 8 of 129
pg. 5 

• • 

, _________ -----·~.,.., _ .. Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 9 of 129
r--~--

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4. Opinions: 

a. Summary of clinical events: 

1. 

pg. 6 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 10 of 129
pg.f 

• 

b. Reasonable expectations of physicians for medical devices: 

i. In the everyday practice of medicine, I along with my 

colleagues/implanting and treating physicians have 

expectations of medical device companies like CR Bard and 

Bard Peripheral Vascular (referred to coiiectively in this report 

as "Bard") when they design, manufacture, market, and sell 

medical devices. Fulfilling these expectations in their design, 

testing, manufacturing, warning, and marketing of NC Filters 

allows physicians to properly and completely obtain informed 

consent from their patients. Fulfillment of these expectations 

also allows physicians to select the appropriate IVC filter and 

make appropriate therapeutic decisions on behalf of their 

patients whether an IVC filter is indicated or considered as a 

therapeutic option, and whether to use or not use a particular 

type of NC filter. 

11. Moreover, a patient has reasonable expectations on what 

he/ she should know in the same or similar circumstances as 

a reasonable patient who has been prescribed or has 

considered having an IVC filter implanted. 

I . j 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 11 of 129
pg. 8 

c. Informed Consent: 

i. The AMA Code of Medical Ethics - CHAPTER 2 : OPINIONS ON 

CONSENT, COMMUNICATION & DECISION MAKING, 2.1.1 

Infonned Consent states: Informed consent to medical 

treatment is fundamental in both ethics and law. Patients 

have the right to receive information and ask questions about 

recommended treatments so that they can make wellconsidered decisions about care. Successful communication in 

the patient-physician relationship fosters trust and supports 

shared decision making. The process of informed consent 

occurs when communication between a patient and physician 

results in the patient's authorization or agreement to undergo 

a specific medical intervention. In seeking a patient's informed 

consent (or the consent of the patient's surrogate if the patient 

lacks decision-making capacity or declines to participate in 

making decisions), physicians should: (a) Assess the patient's 

ability to understand relevant medical information and the 

implications of treatment alternatives and to make an 

independent, voluntary decision. (b) Present relevant 

information accurately and sensitively, in keeping with the 

patient's preferences for receiving medical information. The 

physician should include information about: (i) the diagnosis 

(when known); (ii) the nature and purpose of recommended 

interventions; (iii) the burdens, risks, and expected benefits of 

all options, including forgoing treatment. 

https: //www.ama-assn.org/ sites/ default/files/mediabrowser I code-of-medical-ethics- chapter-2. pdf. 

11 . The AMA Code of Medical Ethics' Opinion 8 .08 - Informed 

Consent states: The patient's right of self-decision can be 

effectively exercised only if the patient possesses enough 

information to enable an informed choice. The patient should 

make his or her own determination about treatment. The 

physician's obligation is to present the medical facts 

accurately to the patient or to the individual responsible for 

the patient's care and to make recommendations for 

management in accordance with good medical practice. The 

physician has an ethical obligation to help the patient make 

choices from among the therapeutic alternatives consistent 

with good medical practice. Informed consent is a basic policy 

in both ethics and law that physicians must honor, unless the 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 12 of 129
pg, 9 

patient is unconscious or otherwise incapable of consenting 

and harm from failure to treat is imminent. In special 

circumstances, it may be appropriate to postpone disclosure of 

information (see Opinion 8.122, "Withholding Information from 

Patients"). 

Physicians should sensitively and respectfully disclose all 

relevant medical information to patients. The quantity and 

specificity of this information should be tailored to meet the 

preferences and needs of individual patients. Physicians need 

not communicate all information at one time, but should 

assess the amount of information that patients are capable of 

receiving at a given time and present the remainder when 

appropriate. 

http://journalofethics.ama-assn.org/2012/07 / coetl1207.html. 

I have adopted the above AMA Codes in my daily practice and, 

in my opinion, they represent the standard of care relative to 

Informed Consent, Patient Communication and Decision 

Making. 

d . Failure to notify: 

i. Given the above responsibilities of the medical device 

manufacturer to the patient and the physician, and the 

physician to the patient, it is my opinion that Bard failed to 

notify the operating physicians and the implanted patients of 

the much higher complication rates associated with the 

Recovery®, G2®, and Eclipse® filters in comparison to the 

original predicate device, the Simon Nitinol Filter®, and 

competitor filters. Instead, Bard continued to represent its 

filters as having superior safety, quality and performance. 

(Example: G2 Brochure: " ... strength and stability to a new 

level.") 

11. There were multiple early safety signals with the Recovery®, 

G2®, and Eclipse® filters. These signals came from adverse 

event reports/ sales data, from reports in the medical 

literature, from Bard's internal risk analysis, and from Bard's 

own in vitro testing indicating low migration resistance 

compared to other filters, and in some instances failing to 

meet Bard's arbitrary minimum threshold for migration 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 13 of 129
·--------.. -----

resistance under a variety of foreseeable circumstances. For 

example, Bard's own internal risk analysis deemed the G2 

filter 

other than electropolishing) to pose an "unacceptable risk" of 

caudal migration. 

ui. 

Bard continued to market the device for both 

permanent and retrievable indications in the prevention of PE 

from DVT. During this time, Bard acknowledged design flaws 

that needed to be corrected, but instead chose to 

inappropriately utilize the data from the Grassi paper, and 

ignore their in house studies, risk analysis and the current 

medical literature, to justify the high complication rates and 

continued marketing practices. In essence, Bard chose to 

keep the product on the market until a new product was 

released rather than focusing on its duty to remove unsafe 

devices from the market. 

1v. At the time 

I 

:~.-· 

Bard's next generation filter, the 

Meridian, was already being marketed and sold - having been 

launched in August of 2011. ·Among other changes, the 

Meridian filter was the first Bard filter to add caudal anchors 

for the purpose of "improving caudal migration resistance and 

tilt performance." As Bard was aware, the Eclipse filter 

(identical to the G2 and G2X filters with exception of 

electropolishing) suffered from a significant increased safety 

risk of caudal migration (a risk which Bard internally deemed 

"unacceptable") over competitor filters, and even earlier Bard 

filters (including the Simon Nitinol). Bard was also aware at 

that time that caudal migration leads to tilt, 

perforation/ penetration, complicated or high risk retrievals 

and fracture. All of this was despite Bard initiating an 

internal project to correct caudal migration of the G2 filter 

beginning in February of 2006, a fact that was not passed on 

to physicians or patients, and making no changes to address 

those caudal migration problems until launch of the Meridian 

in August of 2011 - more than 5 years later. Moreover, 

despite awareness of the need to correct the caudal migration 

problem with its filters, Bard launched the G2X and Eclipse, 

filters to which no changes were made to address the caudal 1 

migration safety risk, prior to launching the Meridian. j' Despite all of this, Bard continued selling the Eclipse~ . 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 14 of 129
I 

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l pg. 11 L ____ ~,-· 

did not remove 

those filters from medical facilities, and did nothing to 

communicate to physicians and patients that the Meridian 

should be used in lieu of the Eclipse. In my opinion, Bard 

should have never launched the Eclipse without the safety 

design changes required by the unacceptable risk of caudal 

migration the company knew existed with the G2 by late 

2005/early 2006. Having made that choice to launch the 

Eclipse without these important patient safety design 

changes, Bard should have stopped selling the Eclipse and 

removed it from all medical facilities at the time it launched 

the Meridian filter. 

v. In addition, Bard's marketing materials falsely represented 

newer generation devices as having greatly improved strength 

and stability when many of the changes in the devices from 

generation to generation were minimal and unproven in their 

impact on safety and efficacy. 

v1. Bard elected not to perform studies to further evaluate the 

safety, effectiveness and durability of their filters. Instead, 

they embarked on a long term plan to evolve their filter 

through multiple generations while making small incremental 

changes to each generation in response to the safety issues 

that were arising in real time in patients that were 

unknowingly participating in a decade long open experiment 

with Bard retrievable filters. 

vn. Had I been 

I would not have used Bard filters 

for the prevention of PE in my patients. I would have also 

advised my partners and colleagues to do the same. It is my 

opinion that Bard did not adequately warn physicians, 

including implanting physician, of important 

safety risks and issues associated with its filters of which it 

was aware. The implanting physician in this case, 

, M. D., seems to agree based on his deposition I 

testimony. As one example, he testified "I wouldn't use the 

filter if I was aware that deaths were occurring concurrently I 

with me placing these filters". (Mulkey Deposition pg. 53, lines 

21-23). l 

--· . --··-· --·--·--·J 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 15 of 129
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pg. 12 

e. 

l. 

represented the Eclipse® IVC filter as a device that could be 

safely placed temporarily, provide effective protection from PE, 

and then be easily removed percutaneously. Given this 

backdrop, I render the following opinions: 

1. 

2 . filter has failed to perform as a 

reasonable physician and/ or patient would expect in 

that it has tilted, caudally m igrated, perforated h er 

vena cava, interacted with and perforated surrounding 

vital organs and structures, a piece of the filter has 

fractured, and the filter cannot be removed via a simple 

percutaneous procedure as intended. This filter 

currently affords no benefit to and only 

exposes her to ongoing risks that include, without 

limitation , further tilt of the filter, further perforation of 

the vena cava, further interactions with and 

penetration of adjacent vital organs and structures, 

furth er fracture of the filter, further caudal migration of 

the filter, increased risk of thrombosis, and the 

development of DVT, PE, caval thrombosis, and filter 

occlusion. 

3. Because the filter could not be removed using the 

standard techniques and equipment recommended by 

Bard, 

Due to the significant 

risks and potential complications associated with open, 

surgical removal of the Eclipse Filter, it is reasonable I 

·-__J 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 16 of 129
pg. 13 

for removal of this filter to first be attempted via 

advanced, complex percutaneous techniques. If this 

retrieval is unsuccessful, surgical removal will be 

necessary. Both procedures have many risks which 

include, without limitation, IVC perforation, bleeding, 

filter fracture, filter migration, IVC thrombosis, IVC 

stenosis, infection, and morbidity and mortality. 

7 . Because of th e above symptoms, and additional risk of 

fracture, migration or increased p enetration, the filter 

cannot remain as a permanent filter as falsely 

marketed and represented to myself and other 

physicians by Bard. Based on my experience, review of 

the available literature, and Bard internal documents, 

Bard retrievable filters lack the durability to remain 

implanted permanently despite being marketed and 

represented by Bard to physicians as safe for 

permanent use. 

ore specifically, the device lacks adequate 

migration resistance, strength and stability. I reviewed 

Ms. Mulkey's medical records and imaging, and 

performed a differential diagnosis in reaching this 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 17 of 129
opinion, and there are no other reasonable causes of 

the failures of her Eclipse Filter. 

f. My opinions are based on the reasonable expectations I and other 

similarly situated physicians have in regards to the responsibilities 

of a medical device manufacturer in regard to the design, 

marketing, sales, and performance of their medical devices. 

g. My opinions are based on my review of scientific and medical 

literature, the materials and medical records/films in this case, 

Bard internal documents, depositions, expert reports, and my 

clinical experience, education and training. I did my own medical 

literature research and review, as well as reviewing literature 

provided to me by the plaintiffs counsel. 

h. In rendering my opinions in this matter, I took into consideration 

medical history and preexisting 

problems. 

1. All of my opinions are to a reasonable degree of medical and 

scientific certainty. 

J· I understand that discovery is ongoing in this case. There may be 

additional information in the form of medical literature, expert 

reports, depositions, and case material. I reserve the right to 

amend my opinions if further pertinent information is 

discovered/ obtained. 

Darren R. Hurst, M. D. 

June 5, 2017 

pg. 14 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 18 of 129
APPENDIX 

Bard Materials and Depositions Reviewed: 

l 

L_~ pg. 15 

1. Janet Hudnall Email to David Rauch dated 2/26/04 

2 . Natalie Wong Email to Doug Uelmen dated 5/20/04 and 

attachment 

3. Natalie Wong Email to Doug Uelmen dated 5/27 /04 

4 . Health Hazard Evaluation from David Ciavarella dated 12/ 17 /04 

5. G2 Perforations from Christopher Ganser dated 11/ 10/05 

6. G2 Caudal Migrations from David Ciavarella dated 12/27 /05 

7. G2 Filter System - indicated for retrieval 

8. G2 Filter System - Patient Questions & Answers 

9. SWOT - Objective: Increase Revenue and Capture More Market 

Share 

10. Monthly Global PV Report from John McDermott dated 2/ 10 /06 

11. Heaith Hazard Evaluation from David Ciavarella dated 2/ 15/06 

12. G2 Caudal Migration Update dated 3/2/06 

13. G2 Fracture Report November 2008 

14. G2 and G2X Fracture Analysis dated 11/30/08 

15. BARD IVC Filter Program May 2009 - Mike Randall 

16. Letter from Stacy Taiber to Brent Adamson, M.D. 

17. Filter Naming Memo from Bill Little dated 4/27/10 

18. Eclipse 510(k) sections on changes to filter from predicate 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 19 of 129
19. 

·1 

Eclipse Product Performance Specification for Migration from I 

Design History File 

20. 

21. 

Meridian Product Performance Specification for Caudal Migration 

from Design History File 

Meridian Value Proposition from Design History File 

22. Meridian Commercialization Plan dated 10 / 1 / 10 

23. G2 Platinum PowerPoint 

24. Scott Karch Email to Dr. Thomas dated 3 / 6 / 12 

25. Brian Barry Deposition - 1/31/14 

26. Robert Michael Carr, Jr. Deposition - 4/17/13 

27. Robert Michael Carr, Jr. Deposition - 10/29/14 

28. Robert Michael Carr, Jr. Deposition - 11/5/ 13 

29. Clement J. Grassi, M.D. Deposition - 7/30/14 

30. Clement J . Grassi, M.D. Deposition - 8/27/14 

31. ClementJ. Grassi, M.D. Deposition - 9/24/14 

32. Murray Asch, M.D. Deposition - 5/2/ 16 

33. Kay Fuller Deposition - 1 / 11 / 16 

34. David Ciavarella, M.D. Deposition - 11/ 12/ 13 

35. Christopher Ganser Deposition - 10 / 11/16 

36. Janet Hudnall Deposition - 11/1/13 

37. John Mcdermott Deposition - 2/5/ 14 

! 38. Gin Shultz Deposition - 1/30/14 

~----~---~·-~-~ 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 20 of 129
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39. Douglas Uelmen Deposition - 10/4/ 14 

40. Carol Vierling Deposition - 5/ 11/ 16 

41. Natalie Wong Deposition- 10/18/ 16 

42. Steven Williamson Deposition - 9/7/16 

43. Medical Monitoring 30(b)(6) Deposition (John Van Vleet) - 1/ 17/17 

Literature Reviewed: 

MEDICAL ARTICLES 

TITLE AUTHOR(S) 

Technical Success and Safety of Retrieval of the 02 Filter in a Prospective, Multicenter 

Binkert 

Study 

In Vitro Metal Fatigue Testing of Inferior Vena Cava Filters Bjarnason 

Comparison of the Recovery and 02 Filter as Retrievable Inferior Vena Cava Filters Cantwell 

Quality Improvement Guidelines for the Performance of Inferior Vena Cava Filter 

Caplin Placement for the Prevention of Pulmonary Embolism 

Complications Encountered with the Use of the Greenfield Filter Carabasi 

Prophylactic and Therapeutic Inferior Vena Cava Filters to Prevent Pulmonary Emboli 

Carlin 

in Trauma Patients 

-

Update on Vena Cava Filters Carman 

02 Inferior Vena Cava Filter: Retrievability and Safety Charles 

Prophylactic Inferior Vena Cava Filters: Do They Make a Difference in Trauma 

Cherry Patients? (abstract only) 

Complications of vena cava filters: A comprehensive clinical review Cipolla 

1 

! 

j 

pg. 1.7 

l.-·---·-·--· ~----·--· --~--·-~-----., ·-· .. -·--~· 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 21 of 129
TrapEase Inferior Vena Cava Filter Placed via the Basilic Arm Vein: A New Antecubital 

Davison 

Access 

Removal of Fractured Inferior Cava Filters: Feasibility and Outcomes Dinglasan 

Celect Inferior Vena Cava Wall Strut Perforation Begets Additional Strut Perforation Dowell 

Perforation of the IVC: Rule Rather Than Exception After Longer Indwelling Times for 

Du rack 

the Gunther Tulip and Celect Retrievable Filters 

"Reporting the Impact of Inferior Vena Cava Perforation By Filters" JOURNAL OF 

Wood 

VASCULAR SURGERY; Vol. 55, No. 1 

Endovascu 

PRESERVE Study to be a Comprehensive Evaluation of Inferior Vena Cava Filter use 

lar Today 

Clinical Experience with the Antecubital Simon Nitinol IVC Filter Engmann 

Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with 

FDA 

Long Term Use 

Percutaneous Inferior Vena Caval Filters: Follow up of Seven Designs in 320 Patients Ferris 

Medical Literature and Vena Cava Filters Girard 

Quality Improvement Guidelines for Percutaneous Inferior Vena Cava Filter Placement 

Grassi 

for the Prevention of Pulmonary Embolism 

Vena Caval Occlusion after Simon Nitinol Filter Placement: Identification with MR 

Grassi 

Imaging in Patients with Malignanacy 

Long-Term Follow-up of the Antheor Inferior Vena Cava Filter Harries 

Retrieval of the Recovery Filters after Arm Perforation, Fracture, and Migration to the 

Hull 

Right Ventricle 

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

Hull 

Fracture, and Migration 

Single Institution Prospective Evaluation of the Over-the-Wire Greenfield Vena Caval 

Johnson 

Filter 

Vena Cava Filter Fracture: Unplanned Obsolescence Johnson 

' pg. 18 

L---~-----------· --·------------

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 22 of 129
Decision Analysis of retrievable inferior vena cava filters in patients without pulmonary Morales 

embolism 

Recovery Vena Cava Filter: Experience in 96 Patients Kalva 

Practice Patterns and Outcomes of Retrievable Vena Cava Filters in Trauma Patients: Karmyan AAST Multicenter Study Jones 

Guidelines for the Use of Optional (Retrievable and Convertible) Vena Cava Filters Kaufman 

Guidelines for the Use of Retrievable and Convertible Vena Cava Filters: Report from 

Kaufman 

the Society of lnterventional Radiology Multidisciplinary Consensus Conference 

Development of a Research Agenda for Inferior Vena Cava Filters: Proceedings from a 

Kaufman 

Multidisciplinary Research Consensus Panel 

Update on Inferior Vena Cava Filters Kinney 

High Risk Retrieval of Adherent IVC Filters: Techniques and Management of 

Kuo 

Thrombotic Complications 

High-Risk Retrieval of Adherent and Chronically Implanted IVC Filters: Techniques for 

Kuo 

Removal and Management of Thrombotic Complications 

Modified Loop Snare Technique for the Removal of Bard Recovery, G2, G2 Express, and 

Lynch Eclipse Inferior Vena Cava Filters 

Removal of the 02 filter: differences between implantation times greater and Less than 

Lynch 180 days 

Complications of the Nitinol Vena Caval Filter Mccowan 

Indications for Vena Cava Filters for Recurrent DVT Miller 

Reporting Standards for Inferior Vena Caval Filter Placement and Patient Follow-up: Millward 

Supplement for Temporary and Retrievable/Optional Filters 

Improving Inferior Vena Cava Filter Retrieval Rates: Impact of a Dedicated Inferior 

Minocha 

Vena Cava Filter Clinic 

Realistic expectations and candidate selection for entry level vascular technologist in a 

Mutyala busy laboratory 

pg. 19 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 23 of 129
Letter to the Editor: A Complication of a 02 Bard Filter 

Complications Related to Inferior Vena Cava Filters: A Single-Center Experience 

Long-term Follow-up of the Bird's Nest IVC Filter 

Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava 

Filters and Clinical Implications Including Cardiac Perforation and Tamponade 

Refrain, Recover, Replace 

Correction to Article About Prevalence of Fracture and Fragment Embolization of Bard 

Retrievable Vena Cava Filters 

Removal of Retrievable Inferior Vena Cava Filters with Computed Tomography Findings 

Indicating Tenting or Penetration of the Inferior Vena Cava Wall 

Recovery 02 Inferior Vena Cava Filter: Technical Success and Safety of Retrieval 

Recovery 02 vena cava filter retrievability study 

Intracardiac Migration of Inferior Vena Cava Filters 

Long-term Results of the Simon Nitinol Inferior Vena Cava Filter 

Aortic Pseudoaneurysm after Penetration by a Simon Nitinol Inferior Vena Cava Filter 

Complications of Inferior Vena Cava Filters 

Outcomes with Retrievable Inferior Vena Cava Filters: A Multicenter Study 

Medical Devices and the FDA Approval Process 

Simon Nitinol Inferior Vena Cava Filter: Initial Clinical Experience 

Vena Caval Filters 

ls Market Growth of Vena Cava Filters Justified? 

Embedded Inferior Vena Cava Filter Removal: Use of Endobronchial Forceps 

Complications of Vascular Access Procedures in Patients with Vena Cava Filters 

l 

! I pg. 20 

L---------------------~----

Nazzal 

Nazzal 

Nicholson 

Nicholson 

Nicholson 

Nicholson 

Oh 

Oliva 

Oliva 

Owens 

Poletti 

Putterman 

Ray 

Ray 

Redberg 

Simon 

Smith 

Smous 

Stavropoul 

OS 

Streib 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 24 of 129
Fracture and Distant Migration of the Card Recovery® Filter: A retrospective Review of 

Tam 

l 

363 Implantations for Potentially Life-Threatening Complications 

Vena Tech Vena Cava Filter: Experience and Early Follow-Up Taylor 

Management if Severe Vena Cava Filter Tilting: Experience with Bard G-2 Filters Turba 

U.S. Food 

FDA Safety Communication: Removing Retrievable Inferior Vena Cava Filters 

and Drug 

Administra 

ti on 

Fractured Bard Recovery, G2, and G2 Express Inferior Vena Cava Filters: Incidence, Vijay Clinical Consequences, and Outcomes of Removal Attempts 

Retrievability and Device-Related Complications of the G2® Filter: A Retrospective 

Zhu 

Study of 139 Filter Retrievals 

Data Desert for Inferior Vena Caval Filters: Limited Evidence, Supervision, and 

Bikdeli 

Research 

Duffett and 

Inferior vena cava filters 

Carrier 

Vena Cava Filter Use in Trauma and Rates of Pulmonary Embolism, 2003-2015 Cook 

------~-----~--~~--· 

l ~~~~~~-~~~~-~---·~~~~~~-~ 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 25 of 129
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Curriculum Vitae: 

Darren R. Hurst, M. D. 

Personal Information: Address: 3325 Stettinius 

Education: 

Cincinnati, OH 45208 

Phone: 513.403.7018 

E-mail: dhurst@cinci.rr.com 

Fellowship in Vascular and Interventional Radiology 

University of Michigan Medical Center 

1999-2000 

Residency in Diagnostic Radiology 

University of Michigan Medical Center 

Dept. Award for Research Excellence 1999 

1995-1999 

Doctor of Medicine 

University of Cincinnati College of Medicine 

AOA Honor Society 1994-95 

1991-95 

B. A. in Zoology 

Miami University, Oxford, Ohio 

Cum Laude with University Honors 

1987-91 

Employment Experience: 

Radiology Associates of Northern Kentucky 

Managing partner 

Regional multispecialty radiology and imaging group 

2001-Present 

Director Vascular & Interventional Associates 

Division of Radiology Associates of NKY 

Private practice VIR group 

2003-Present 

Director VIA Vein Center 

l 

-~· ___ I 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 26 of 129
!~----,·--·-----~---~--~--'· 

J 

Hospital Affiliations: 

Comprehensive Vein Center 

2013-Present 

Chief of Vascular & Interventional Radiology 

St. Elizabeth Hea lth System 

2003-Present 

Director IR Spine Intervention 

St. Elizabeth Spine Center 

St. Elizabeth Health 

2009-2016 

Physician Trainer for Spine Intervention 

Stryker International 

2011-2015 

St. Elizabeth Health 

Edgewood Campus 

1 Medical Village Drive 

Edgewood, Kentucky 41017 

859-344-2000 

St. Elizabeth Health 

Covington Campus 

401 East 20th Street 

Covington, Kentucky 41014 

859-292-4000 

St. Elizabeth Health 

Ft. Thomas Campus 

85 North Grand Avenue 

Ft. Thomas, Kentucky 41075 

859-572-3100 

St. Elizabeth Health 

Florence Campus 

7 380 Turf way Road 

Florence, Kentucky 41042 

859-962-5200 

Private Practice Office: 

pg. 23 J 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 27 of 129
Certification: 

Vascular and Interventional Associates 

VIA Vein Center 

Center for Spine Health 

375 Thomas More Parkway 

Crestview Hills, KY 41017 

859-341-4841 

ABR Certified in General Diagnostic Radiology 1999 

ABR CAQ Board Certification 

Vascular and Interventional Radiology 2001 

ABR MOC/CAQ lOyr Recertification 

Vascular and Interventional Radiology 2011 

Kentucky License #35686 

Ohio License #4536 

Indiana License #010682666A 

Professional Organizations: 

Publications: 

RSNA: 1995 

ARRS: 1995 

ACR: 1998 

SIS: 2010 

SIR: 1999 

ACP: 2015 

Hurst DR, Forauer AR, Bloom JR et al: Diagnosis and Endovascular 

Treatment of Iliocaval Compression Syndrome. J Vase Surg 34(1): 106-13, 

2001. 

Hurst DR, Kazerooni EA, Williams DM, Stafford-Johnson D, Platt JF, Prince 

MR: Diagnosis of Pulmonary Embolism: Comparison of MR Angiography and 

CT Angiography in Canines. JVIR 10:309-318, 1999. 

Dong Q, Hurst DR, Wienmann HJ, Chenevert TL, Londy FJ, Prince MR: 

Magnetic Resonance Angiography With Gadomer-17 : An Animal Study 

L

Original Investigation. Investigative Radiology 33:699-708, 1998. 

pg. 24 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 28 of 129
r Donnelly LF, Hurst DR, Strife JL, Shapiro RM: Plain Film Assessment of I Pulmonary Flow in the Neonate with D-Transposition of the Great Vessels. 

Pediatric Radiology 25: 195-7, 1995. 

Research: 

VOYAGER PAD Study: An international, multicenter, randomized, doubleblind, placebo-controlled phase 3 trial investigating the efficacy and safety of 

rivaroxaban to reduce the risk of major thrombotic vascular events in patients 

with symptomatic peripheral artery disease undergoing lower extremity 

revascularization procedures. Lead Investigator St. Elizabeth Health System 

2014-present. 

ATTRACT Study: a multicenter randomized trial to evaluate 

pharmacomechanical catheter-directed thrombolysis for the prevention of 

postthrombotic syndrome in patients with proximal deep vein thrombosis. 

Lead Investigator St. Elizabeth Health System 2013-present. 

The CAPTURE registry: analysis of strokes resulting from carotid artery 

stenting in the post approval setting: timing, location, severity, and type. Coinvestigator St. Elizabeth Health System 2005-2007. 

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization. 

Lead Investigator St. Elizabeth Health System 2001 -2005. 

J 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 29 of 129
r Testimony List: 

I 

1. Su san Gail Smith v. St. Mary's Medical Center et al. 8 / 11/2015 

2. Barbara Bongiorno v. Phillip Adler M. D.; St. John Macomb Hospital 

1/21/2016 

3. James Alley v. Hillcrest Medical Center et al. 3/ 15/ 16 

4 . Edith Fish v. Diallo et al. 11 /7 /2016 

5. Austin v. CR Bard Inc. 8/19/16 

6. Austin v. CR Bard Inc. 11/ 16/ 16 

Fee Sch edule: 

1. My current fee for the following medical legal activities is $500.00 per 

hour. This includes medical records review, review of depositions, 

literature searches, consultation time, preparation for deposition and 

trial testimony, oral or written reports, all travel time (billed as portal to 

portal), or any miscellaneous task as requested by client. 

2. My current fee for all local deposition and trial activities is $750.00 per 

hour. "' 

3. All out of area travel that requires an overnight stay is billed at $6000.00 

per day. If I have to use a half day for travel or return from the location 

of trial or deposition, that will be billed at 3000.00 per half day. If I must 

cancel an entire office day to provide the requested services, an 

additional fee of $2000.00 per clinic/work day will be charged. Trial and 

out of area fees must be paid in advance of the date of travel. 

pg. 26 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 30 of 129
EXHIBIT C

FILED REDACTED

REDACTED DOCUMENTS 

RELATED TO DOCKET 7946

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 31 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 UNITED STATES DISTRICT COURT 

DISTRICT OF ARIZONA 

No. MD-15-02641-PHX-DGC 

3 

4 In Re: Bard IVC Filters Products 

Liability Litigation 

5 

DO NOT DISCLOSE - SUBJECT TO FURTHER 

6 CONFIDENTIALITY REVIEW 

7 

WITNESS: , M.D. 

8 

9 Pursuant to Fed. R. Civ. P. 26 and 30 

10 the videotaped deposition of Roderick Tompkins, 

11 M.D. was taken before Janine N. Leroux, 

12 Stenographic Court Reporter and Notary Public - 

13 Special Commission in and for the State of 

14 Kentucky at Large, at the 613 23rd Street, Suite 

15 440, Ashland, Kentucky on Tuesday, April 11, 

16 2017, commencing at the approximate hour of 4:45 

17 p.m. Said deposition was taken pursuant to 

18 Notice. 

19 

20 

21 

22 

23 

24 

25 

Golkow Technologies, Inc. Page 1 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 32 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 be -- I will be doing the same thing on my 

2 objections. 

3 BY MR. DeGREEFF: 

4 Q Has anyone from Bard ever made you 

5 aware of deaths caused by the Bard IVC filters? 

6 A No. 

7 Q If there were deaths caused by Bard IVC 

8 filters that you were using in patients, is that 

9 something you'd want to know? 

10 MS. HELM: Object to the form. 

11 A Yes. 

12 Q It would be important for you to know, 

13 right? 

14 A Yes. 

15 Q Something you would consider in making 

16 your decisions about which filter to use? 

17 MS. HELM: Object to the form. 

18 A If it -- yes. 

19 Q And is that something that you would 

20 pass on to your patients? 

21 A I wouldn't use the filter if I was 

22 aware that deaths were occurring concurrently with 

23 me placing these filters. 

24 Q Okay. Are you aware that -- that 

25 perforation is progressive in nature? 

Golkow Technologies, Inc. Page 53 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 33 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 accounts, yes. 

2 MS. HELM: Object to the form. 

3 A And so what was the question? 

4 Q I'll withdraw it. 

5 We were talking earlier about sales 

6 representatives being present when you were doing 

7 IVC placements in bariatric patients. Do you 

8 remember that? 

9 A Yes. 

10 Q Did you ever have any specific 

11 discussions with those reps about the use of IVC 

12 filters in bariatric patients? 

13 A I don't recall. 

14 Q Okay. Do you remember ever being told 

15 by any Bard sales representative that IVC filters 

16 should not be used in bariatric patients? 

17 A No. 

18 Q Would you expect the -- the information 

19 that a -- that a medical device sales rep was -- 

20 was providing to you to be honest, accurate and 

21 complete? 

22 A Yes. 

23 Q And would the same be true of a medical 

24 device company in general? 

25 A Yes. 

Golkow Technologies, Inc. Page 55 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 34 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 product? 

2 A Yes. 

3 Q And something that you would use when 

4 meeting with patients? 

5 A Yes. 

6 Q If there were problems with one of 

7 Bard's IVC filters such as the Eclipse for 

8 example, would you have expected the Bard sales 

9 rep to inform you of those problems? 

10 MS. HELM: Object to the form. 

11 A Yes. 

12 Q And were you ever told by any Bard 

13 sales representative about problems with the 

14 . Eclipse filter? 

15 MS. HELM: Object to the form. 

16 A No. 

17 Q Were you ever told by any Bard sales 

18 representative about any -- any problems or 

19 complications associated with any of their 

20 filters? 

21 MS. HELM: Object to the form. 

22 A No. 

23 Q Sir, let's go through some of your 

24 records, and I'm going to try to -- I tried to 

25 find the earliest I could find. 

Golkow Technologies, Inc. Page 57 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 35 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

possible IVC filter insertion prior to 

laparoscopic gastric bypass due to limited 

mobility." 

4 Did I read that correctly? 

5 A Yes. 

6 Q And why did you believe -- at this 

7 point were you recognize -- were you actually 

8 talking about putting in a filter, or were you 

9 just talking about the possibility of an IVC 

10 filter? 

11 A Possibility of placing a filter. 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 Q So the limited mobility would have been 

23 the basis for the potential hyper-coagulative 

24 state? 

25 A Yes. 

Golkow Technologies, Inc. Page 71 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 36 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 sentence says, "The proximal duodenum was normal," 

2 correct? 

3 A Yes. 

4 Q And what is the proximal duodenum? 

5 A There's four parts to the duodenum. 

6 The proximal duodenum is the first part. 

7 Q Okay. Am I saying it correct or wrong 

8 when I say duodenum? 

9 A It depends on what country you're from. 

10 Q Okay. What country says is that way? 

11 A England. 

12 Q So how should I be saying it? 

13 A Duodenum. 

14 Q That's what I used to say but then -- 

15 MR. O'CONNOR: I told you. 

16 Q -- everybody else said duodenum. So I 

17 should go with duodenum? 

18 A In America it's normally duodenum. 

19 Q Perfect. I am definitely from America. 

20 All right. So looking at Page 13, this 

21 appears to be a operative report 

22 from a ; is that correct? 

23 A Yes. 

24 Q And what was the purpose of this 

25 ? 

Golkow Technologies, Inc. Page 77 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 37 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 Bates No. 19 is again , right? 

2 A Yes. 

3 Q And then : 

 correct? 

5 A Yes. 

6 Q

? 

8 MS. HELM: Object to the form. 

9 A A

11 Q

13 A 

14 Q

19 I guess did I read that first sentence 

20 correctly? 

21 A Yes. 

22 Q

Golkow Technologies, Inc. Page 80 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 38 of 129
1

2 Do you remember in particular what was 

3 discussed with 

4 

A What's typed right there. 

Q Okay. And what would you have told 

A What is right there. 

Q Let -- let me ask you when you're 

10 talking about 

14 A . 

15 Q ? 

16 A Yes. 

17 Q Okay.

Would -- 

19 

20 

21 A Yes. 

22 

23 

24 A Perforation of the filter? 

25 Q All right. Well -- 

5 

7 

8 

9 

Do Not Disclose - Subject to Further Confidentiality Review 

Golkow Technologies, Inc. Page 81 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 39 of 129
2 Q Yeah, that's a -- fair enough. 

5 

6 

A Not past insertion. 

Q Okay. So you would have been talking 

8 A Yes. 

9 Q And what -- and what about -- and then 

1 MS. HELM: Object to the form. 

3 

4 

7 about surgical only? 

10 you -- and then you 

11

12 

13 

14 

15 

16 

17 Q Okay. So

20 A Yes. 

21 Q

25 A Yes. 

L

Golkow Technologies, Inc. Page 82 

Do Not Disclose - Subject to Further Confidentiality Review 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 40 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

Golkow Technologies, Inc. Page 83 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 41 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 

2 

3 

4 

5 

6 

7 

8 

9 MS. HELM: Object to the form. 

10 

11 

12 

13 

14 

15 

16 MS. HELM: Object to the form. 

17 

18 

19 MS. HELM: Object to the form. 

20 

21 

22 

23 

24 

25 

Golkow Technologies, Inc. Page 84 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 42 of 129
MS. HELM: Object to the form. 

Do Not Disclose - Subject to Further Confidentiality Review 

10 

11 

12 MS. HELM: Object to the -- 

13 Q -- is that correct? 

14 MS. HELM: Object to the form. 

15 A In our discussion here, no. I assume 

16 you have the consent form in here somewhere. 

17 Q I do. And we'll -- we'll talk about 

18 that. 

19 But isn't the -- would the consent form 

20 essentially have the same -- is it essentially a 

21 statement of -- 

22 A Yes. 

23 MS. HELM: Object to the form. 

24 Q Would there be things in the consent 

25 form that would be different than what you've 

Golkow Technologies, Inc. Page 85 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 43 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 listed here? 

2 

3 

4 

5 

6 

A No. 

8 A What is there, an FDA statement had 

9 come out shortly prior to this that we began to 

10 inform the patients that the FDA said it should be 

11 removed. 

12 Q Are you talking about the July 2010 FDA 

13 statement? 

14 A Are there others? 

15 Q (Laughter). Do you remember 

16 specifically when they 

17 A No. 

18 Q Okay. And what did the FDA say about 

19 removal of IVC filters? 

20 A They should be retrieved if possible. 

21 Q And why? 

22 MS. HELM: Object to the form. 

23 A I don't recall. 

24 Q Was it your intention and expectation 

25 that the IVC filter you were going to place into 

Golkow Technologies, Inc. Page 86 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 44 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 And so this was a record from 

2 April 11th of 2012; is that correct? 

3 A Yes. 

4 MS. HELM: Exactly five days ago today. 

5 MR. DeGREEFF: Hey, you were married 

6 exactly -- 

7 MS. HELM: 25 years ago today. 

8 MR. DeGREEFF: That's right. Happy 

9 anniversary by the way. 

10 MS. HELM: Where is my bottle of 

11 champagne? 

12 MR. DeGREEFF: I know who would you 

13 rather be with? 

14 MS. HELM: On the advice of counsel I 

15 decline to answer. 

16 MR. DeGREEFF: There you go. All 

17 right. I'm sure I'm super high on that list. 

18 BY MR. DeGREEFF: 

19 Q So -- so in -- in deciding which -- 

20 which filter to use, do you rely on information 

21 from the manufacturer? 

22 A No. 

23 

24 

25 A That's what I'm looking for. 

Golkow Technologies, Inc. Page 88 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 45 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 A Okay. 

2 Q All right. You state that the risks -- 

3 indications and findings it says, "The risks 

4 and benefits were discussed with the patient and 

5 consent was obtained." 

6 Did I read that correctly? 

7 A Yes. 

8 Q And is that -- would you have told her 

9 anything other than what we have already 

10 discussed? 

11 A No. 

12 Q And is this -- is this consent that was 

13 obtained, is that a reference to the consent 

14 document? 

15 A Yes. 

16 MR. DeGREEFF: 9? 

17 COURT REPORTER: Yes. 

18 MR. DeGREEFF: Thank you, ma'am. 

19 (DEPOSITION EXHIBIT 9 WAS MARKED.) 

20 BY MR. DeGREEFF: 

21 Q I'm handing you what's been marked as 

22 Deposition Exhibit 9. So does that appear to be 

23 the consent -- 

24 

25 A Yes. 

Golkow Technologies, Inc. Page 94 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 46 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 Q And if you'll look at the -- and this 

2 is a consent -- this is titled 'Consent to 

3 Operation or Other Procedures', correct? 

4 A Yes. 

5 Q So is this a consent to the 

6 complications -- potential complications 

7 associated with the with the actual procedure 

8 for implantation? 

9 A Yes. 

10 

11 

12 

13 A Yes. 

14 Q And then the paragraph under that says, 

15 "Some of the common additional risks particular to 

16 this surgery is/are", and then it lists, 

17 "malfunction/dysfunction of filter, blood vessel 

18 injury." Did I read that correctly? 

19 A Yes. 

20 Q And again, is that the same 

21 information that -- or strike that. 

22 Would there be anything different about 

23 this than what we discussed earlier with regard to 

24 your consent discussion with her? 

25 A No. 

Golkow Technologies, Inc. Page 95 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 47 of 129
Do Not Disclose - Subject to Further Confidentiality Review 

1 inspected the filter and delivery system for any 

2 damage prior to implanting it? 

3 A I would have looked at it, yes. 

4 Q Okay. You wouldn't have -- I guess 

5 strike that. 

6 Would you have implanted it if there 

7 was any indication of damage or a problem with the 

8 filter? 

9 A No. 

10 Q And you didn't -- did you do anything 

11 to alter or change the filter before implantation? 

12 A No. 

13 Q Is it fair to say that you -- strike 

14 that. 

15 Did you just open the package and make 

16 sure it wasn't damaged and go ahead and implant 

17 it? 

18 MS. HELM: Object to the form. 

19 A Yes. 

20 Q At the time you implanted the filter, 

21 did you expect the filter to perform properly? 

22 MS. HELM: Object to the form. 

23 

24 

25 Q Okay. Did you -- did you expect the 

Golkow Technologies, Inc. Page 97 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 48 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 filter to tilt and become irretrievable at the 

2 time that you placed it? 

3 A No. 

4 MS. HELM: Object to the form. 

5 

6 

7 MS. HELM: Object to the form. 

8 A I'm not aware of that. Or did I expect 

9 it to perforate? Read that back. 

10

11

12 MS. HELM: Object to the form. 

13

14

15 Q No, okay, strike that. No, that's not 

16 what I meant. 

17

18

19

20 A No. 

21 MS. HELM: Object to the form. 

22

23

24

25 A No. 

Golkow Technologies, Inc. Page 98 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 49 of 129
1 Q Would you -- if you expected those 

2 those issues to occur, would you have used the 

3 filter? 

4 MS. HELM: Object to the form. 

5 A No. 

6 Q And is it -- in your opinion is it 

7 reasonable for a patient to expect those 

8 complications not to occur? 

9 MS. HELM: Object to the form. 

10 A Unfortunately there's complications 

11 with any product. 

12 

13 

14 

Q Well, if -- if a patient is not 

informed of those complications, they can't 

reasonably make a decision whether -- strike that. 

15 Move on. 

16 The IVC filter complications can occur 

17 even if -- even if the implanting physician does 

18 everything correctly; is that correct? 

19 MS. HELM: Object to the form. 

20 A Yes. 

21 Q Doctor, would you agree that a -- that 

22 a perforation of the vena cava filter is is not 

23 within a patient's reasonable expectations? 

24 MS. HELM: Object to the form. 

25 A The perforation of the vena cava 

-- 

Do Not Disclose - Subject to Further Confidentiality Review 

Golkow Technologies, Inc. Page 99 

Case 2:15-md-02641-DGC Document 8385-2 Filed 10/24/17 Page 50 of 129
Do Not Disclose Subject to Further Confidentiality Review 

1 Q Strike that. Let me see if I can say 

2 that a better way. 

3 Is it reasonable for a -- for a patient 

4 to expect a vena cava filter not to penetrate its 

5 -- their vena cava? 

6 MS. HELM: Object to the form. 

7 A It's reasonable that they wouldn't 

8 expect that, yes. 

9 Q Okay. And would it -- is it reasonable 

10 for a patient to expect an IVC filter not to 

11 penetrate their organs? 

12 MS. HELM: Object to the form. 

13 A That is what they should expect. 

14 Q In your -- and in your experience would 

15 it be a rare and unusual circumstance where a vena 

16 cava filter would perforate a patient's organs? 

17 MS. HELM: Object to the form. 

18 A Yes. 

19 Q That's not something that you would 

20 expect to occur, correct? 

21 MS. HELM: Object to the form. 

22 A It's certainly within the realm of 

23 small risks. 

24 Q Is it -- when you're putting a filter 

25 into a patient, that's not something you would 

Golkow Technologies, Inc. Page 101 

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Do Not Disclose - Subject to Further Confidentiality Review 

1 expect to occur; is that fair? 

2 MS. HELM: Object to the form. 

3 A It's something that can occur, but it's 

4 not something I would expect to occur. 

5 Q Okay. Doctor, what is -- that would 

6 not be within your reasonable expectation of an 

7 outcome from a -- from a future implantation -- of 

8 a future outcome from an implanted IVC filter, 

9 fair? 

10 MS. HELM: Object to the form. 

11 A It would be a possible but not likely 

12 outcome. 

13 Q Okay. Doctor, are you -- do you know 

14 what an IFU is? 

15 A I have heard but I've forgotten. 

16 Q Are you familiar with the instructions 

17 for use for vena cava filters? 

18 A Yes. 

19 (DEPOSITION EXHIBIT 10 WAS MARKED.) 

20 Q I'm handing you what's been marked as 

21 Exhibit 10. Have you seen the instructions for 

22 use for the Eclipse filter before? 

23 A Yes. 

24 MS. HELM: Are you representing that 

25 this is the IFU filter at issue? 

Golkow Technologies, Inc. Page 102 

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Do Not Disclose - Subject to Further Confidentiality Review 

1 to be contraindicated for something? 

2 A Those are the situations in which it's 

3 not advisable to place it. 

4 Q If a -- if a -- if something was listed 

5 as a contraindication for use in the IFU, would 

6 you implant the filter in -- in those situations? 

7 A No. 

8 Q Contraindications for use does not 

9 include bariatric surgery, does it? 

10 A No. 

11 Q If -- if contraindications for use in 

12 the Eclipse IFU had listed bariatric surgery, 

13 would you use the filter in bariatric patients? 

14 A No. 

15 Q Do you review the IFU for medical 

16 devices that you use? 

17 A I have seen this. I don't know that 

18 I've read every word in it. 

19 Q Okay. Is it your practice, though, to 

20 review the IFU for devices that you're implanting 

21 into your patients? 

22 A If it's a new device, I would look it 

23 over. 

24 Q And is -- and part of the reason you 

25 review an IFU is so that you can properly inform 

Golkow Technologies, Inc. Page 105 

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Do Not Disclose - Subject to Further Confidentiality Review 

1 patients; is that correct? 

2 MS. HELM: Object to the form. 

3 A No. 

4 Q You wouldn't -- you wouldn't inform 

5 patients of warnings that are listed in an IFU? 

6 A If they were pertinent. 

7 Q Okay. If the IFU included pertinent 

8 warnings, is that something that you would pass on 

9 to your patients? 

10 A Yes. 

11 Q I want you to look at the -- at the 

12 warnings section. If you look on it's Page 881. 

13 12 says, "Movement" -- 

14 A Which 12, the upper? 

15 Q The upper -- 

16 A The top 12? 

17 Q The upper 12, sorry, under the warnings 

18 sections it says, "Movement, migration or tilt of 

19 the filter are known complications of vena cava 

20 filters. 

21 Migration of the filters to the heart 

22 or lungs has been reported. There have also been 

23 reports of the caudal migration of the filter." 

24 Did I read that correctly? 

25 A Yes. 

Golkow Technologies, Inc. Page 106 

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Do Not Disclose - Subject to Further Confidentiality Review 

1 Q This section -- strike that. 

2 Does this make any differentiation 

3 between Bard filters and competitor filters? 

4 A I don't know. 

5 Q Would you read it to make any 

6 differentiation between Bard filters and 

7 competitor filters? 

8 MS. HELM: Object to the form. 

9 A Would I read what? 

10 Q The language we just talked about. 

11 "Movement, migration or tilt of the filter are 

12 known complications of vena cava filters." 

13 That's discussing all vena cava 

14 filters, correct? 

15 MS. HELM: Object to the form. 

16 A That's how I would read it, yes. 

17 Q Is there anything about that statement 

18 that informs you of an increased risk of movement, 

19 migration or tilt with Bard filters versus 

20 competitor filters? 

21 A No. 

22 Q Is there anything about that statement 

23 that warns you of an increased risk of movement, 

24 migration or tilt with Bard filters versus -- Bard 

25 optional filters versus Bard's permanent filters? 

Golkow Technologies, Inc. Page 107 

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Do Not Disclose - Subject to Further Confidentiality Review 

1 MS. HELM: Object to the form. 

2 A No. 

3 Q There's -- is there anything that would 

4 about that language that would lead you as a 

5 physician to believe that the Eclipse had a higher 

6 risk of movement, migration or tilt than any other 

7 filter? 

8 MS. HELM: Object to the form. 

9 A No. 

10 Q If the -- if the Bard filter, the 

11 Eclipse, had an increased risk of migration over 

12 other filters, is that something you would want to 

13 know? 

14 MS. HELM: Object to the form. 

15 A Yes. 

16 Q Is that something you would take into 

17 account in your risk benefit analysis on whether 

18 to use the filter? 

19 A Yes. 

20 Q Would it effect your prescribing 

21 habits? 

22 A Yes. 

23 Q Is it something you would pass on to 

24 the patient? 

25 A If it's a significant difference, I 

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1 wouldn't use the filter. 

2 Q Doctor, as a -- as a physician, would 

3 you want to use the safest available IVC filter 

4 that would establish the goal of stopping PEs? 

5 MS. HELM: Object to the form. 

6 A Yes. 

7 Q And, Doctor, just below that there's 

8 a in bold it says, "See potential complications 

9 section for further information regarding other 

10 known filter complications." 

11 Did I read that correctly? 

12 A I don't see that. 

13 Q It's the bold right below No. 14. 

14 MS. HELM: My copy is so bad you can't 

15 tell that it's bolded. 

16 A Yeah, I don't know that it's bold. 

17 Yeah, I see what you're saying. 

18 Q And it says, "See potential 

19 complications section for" -- and for the record 

20 this is how it was produced to us, so there's not 

21 a lot we can do about it. 

22 And it says, "See potential 

23 complications for further information regarding 

24 other known filters complications." 

25 Did I read that correctly? 

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1

2

3 A Yes. 

4

5

6

7

8

9

10 Q Okay. And when a -- when a filter 

11 becomes embedded and irretrievable, the patient 

12 continues to have the risk of tilt -- I mean the 

13 risk of perforation of the filter, correct? 

14 MS. HELM: Object to the form. 

15 A I'm not an expert on the long-term 

16 consequences of filters. 

17 Q Okay. So as you sit here, you're not 

18 -- you're not -- you don't consider yourself an 

19 expert on any long-term complications of filters? 

20 A No. 

21 Q Okay. Have you spoken to the 

22 interventional radiologist who tried to remove the 

23 filter? 

24 A Not that I'm aware of. 

25 MR. DeGREEFF: Go ahead. No, wait. I 

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1 penetration of the IVC filter into the duodenum 

2 could cause chronic abdominal pain? 

3 MS. HELM: Object to the form. 

4 A Perforated intraluminally into the 

5 duodenum? 

6 Q Yes. 

7 A Potentially. 

8 Q What about tenderness of the abdomen? 

9 A If the vena cava filter were visible 

10 within the lumen of the duodenum, then it may 

11 cause some ulceration. 

12 Q Which would leave the tenderness of the 

13 abdomen? 

14 A Yes. 

15 Q And what about abdominal cramping? 

16 A 

17 Q What about nausea? 

18 A Well, your -- yes. 

19 

20 

21 A No. 

22 

23 

24 

25 A No. 

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1

2

3 A No. 

4 MR. DeGREEFF: Go ahead. 

5 DIRECT EXAMINATION 

6 BY MR. O'CONNOR: 

7 Q All right. Doctor, I'm Mark O'Connor 

8 and I'm another lawyer representing the Plaintiff 

9 in this matter. I have some additional questions. 

10 I've sat here and listened to you and 

11 it sounds to me as though you are a medical doctor 

12 who places your patients' interest and safety and 

13 their well-being as a No. 1 priority; is that 

14 fair? 

15 MS. HELM: Object to the form. 

16 A That and having a outcome, yes. 

17 Q And is it fair to say, Doctor, that you 

18 would expect that a medical device manufacturer 

19 would similarly place a patient's interest and 

20 safety first as a priority when it is promoting a 

21 medical device? 

22 MS. HELM: Object to the form. 

23 A Sometimes there are risks to devices 

24 but. 

25 Q As a general rule, though, is it your 

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1 I'm not a marketing expert. I don't know -- 

2 Q Setting marketing aside, if Bard was 

3 aware that there were rates of complications 

4 stemming from caudal migration in the Eclipse 

5 filter, I think we've agreed that that's something 

6 you would have expected them to tell you? 

7 MS. HELM: Object to the form. 

8 A Yes. 

9 Q And told you as soon they knew, right? 

10 MS. HELM: Object to the form. 

11 A As soon as they verified there was a 

12 significant issue. 

13 Q And if they were receiving feedback 

14 from other doctors that there were problems in the 

15 Eclipse with caudal migration as early as 2010, is 

16 that something you also would have expect to 

17 notify you as a doctor who was using the Eclipse? 

18 MS. HELM: Object to the form. 

19 A I -- I wouldn't expect that from A 

20 marketing standpoint. I would assume they would 

21 improve the filter. 

22 Q Well, you would expect Bard to provide 

23 you with accurate and through information as it 

24 became aware of problems with the filter, right? 

25 A Yes. 

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1 A Yes. 

2 Q If Bard was aware that there were 

3 problems with the designs of a filter that was on 

4 the market that was causing complications and 

5 problems with patients, would you expect Bard to 

6 notify you about that immediately? 

7 MS. HELM: Object to the form. 

8 A Yes. 

9 Q And would you expect Bard to notify you 

10 immediately if it was in the process of 

11 redesigning the filter in a manner to reduce or 

12 avoid the complications? 

13 MS. HELM: Object to the form. 

14 A Yes. 

15 Q Because that information would help you 

16 decide whether you even wa.ntc.d to use the filter 

17 in the first place, true? 

18 A Yes. 

19 MS. HELM: Object to the form. 

20 Q Did you have an understanding, Doctor, 

21 you -- you had the Eclipse filter. Did you have 

22 an understanding that there were filters that were 

23 launched by Bard that were predecessors to the 

24 Eclipse filter? 

25 A Was I aware there were predecessors? 

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1 complications because of her physical condition, 

2 correct? 

3 A Yes. 

4

5

6

7 A Yes. 

8 Q Okay. And so that was part of your 

9 risk-benefit analysis? 

10 A Yes. 

11 Q Okay. If you would turn the page of 

12 this IFU, which marked I've as Exhibit 17, and on 

13 the next page under G you see where it says, 

14 'Potential complications"? 

15 A Yes. 

16 Q And it says, "Possible complications 

17 include but are not limited to the following." Do 

18 you see where I am? 

19 A Yes. 

20 Q And again -- again they tell you 

21 "Movement, migration or tilt the filter are known 

22 complications of vena cava filters," correct? 

23 A Yes. 

24 Q And they also tell you that "Migration 

25 of filters to the heart or lungs have been 

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1 intervention." 

2 Did I read that correctly? 

3 A Yes. 

4 Q

5 Bard told you -- had 

6 told you that there had -- that complications 

7 could result in medical intervention and/or death, 

8 correct? 

9 A They provided me with this literature. 

10 Yes, they provided you with 

11 information. 

12 A Yes. 

13 Q And they told you that there had been 

14 reports of complications including death 

15 associated with the use of IVC filters in morbidly 

16 patients, correct? 

17 A They provided me with literature that 

18 stated that, yes. 

19 Q Yes, okay. And they provided you with 

20 literature that stated you needed to take that 

21 into consideration when doing your risk-benefit 

22 analysis in deciding whether to implant a filter 

23

24 A Yes. 

25 Q Okay. And this information was 

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1 available to you when you made that risk-benefit 

2 analysis? 

3 A Yes. 

4 Q Okay. Today you were shown a number of 

5 internal documents from Bard. Do you recall 

6 those? 

7 A Yes. 

8 Q Some e-mails and some other internal 

9 documents. Do you recall those? 

10 A Yes. 

11 Q During the course of your practice, has 

12 any medical device company ever shown you their 

13 internal documents? 

14 A No. 

15 Q During the course of your practice, has 

16 any internal -- any medical device company ever 

17 shown you a draft e-mail? 

18 A No. 

19 Q Okay. It is important to you to have 

20 reliable information when making a risk-benefit 

21 analysis on whether to use a medical device. Do 

22 you agree with me on that? 

23 A Yes. 

24 Q Okay. As you sit here today, you don't 

25 know the context of any of these internal Bard 

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1 Q Doctor, a Bard representative sat with 

2 you and helped you place filters in bariatric 

3 surgery patient, correct? 

4 A He -- 

5 MS. HELM: Object to the form. 

6 A He was present. 

7 Q He was present while you were doing it? 

8 A Yes. 

9 Q And why did you want him there? Why 

10 did you -- why was he is present? What was the 

11 purpose of him being there? 

12 A To provide information if I had 

13 questions. 

14 Q Okay. To help you if you needed it? 

15 A To provide information. He wouldn't 

16 physically help me. 

17 Q At any point did he tell you, hey, you 

18 shouldn't use that IVC filter with bariatric 

19 patients? 

20 A Not that I recall. 

21 Q If -- if there was some concern within 

22 Bard about -- about using IVC filters with -- with 

23 bariatric patients, would you have expected him to 

24 tell you that? 

25 MS. HELM: Object to the form. 

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1 filter -- 

2 A Yes. 

3 Q -- you did not have all the -- based on 

4 the documents you've seen here today, there are 

5 things that Bard didn't tell you about risks and 

6 problems with its filters, fair? 

7 MS. HELM: Object to the form. 

8 A Yes. 

9 Q Now, Doctor, your care and treatment 

10 with regard to the filters was to implant the 

11 filters, fair? 

12 A Yes. 

13 Q You didn't do explants of the filters? 

14 A No. 

15 Q You didn't -- you didn't CT scan 

16 filters and check for complications? 

17 A No. 

18 Q So when it comes to complications that 

19 your patients may or may not have had, the 

20 person -- you may not be the right person to talk 

21 to; is that fair? 

22 A If they return for follow-up, then I 

23 would think that they would make me aware. 

24 Q And we talked about the fact that -- 

25 that eventually as many as 85 percent stop 

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