EXHIBIT 111 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 1 of 105
From: Randall, Mike [/o=BARD/ou=TPE AG/cn=Recipients/cn—MRandall] 

To: Randall, Mike [Mike.Randall@crbard.com], Conaway, Jon [/o—BARD/ou=TPE 

AG/cn=Recipients/cn=jconaway], Baird, Bret [/o=BARD/ou=TPE 

AG/cn—Recipients/cn=BBaird], Chanduszko, Andre [/o=BARD/ou=TPE 

AG/cn=Recipients/cn=achanduszko], Garcia, JoseL [/o=BARD/ou=LPD 

AG/cn=Recipients/cn=JGarcia], Boyle, Brian [/o—BARD/ou=TPE 

AG/cn=Recipients/cn=BBoyle] 

CC: Carr, Robert [/o=BARD/ou=TPE AG/cn=Recipients/cn=RCarr] 

BCC: TPE-Saguaro [/o=BARD/ou=TPE AG/cn=Recipients/cn=TPE-Saguaro] 

Subject: Platinum DIS discussion 

Attachments: DIS-8049, rev.l.doc 

Location: TPE-Saguaro 

StartTime: 6/23/2008 6:00:00 PM 

EndTime: 6/23/2008 7:00:00 PM 

Timezone: 

Hi All, 

This meeting is to kick off the DIS for Platinum. The goal of this meeting is to determine what inputs we 

need to complete the DIS which will drive the project scope. Please think before hand how we can get 

the information we need to support the following: 

1) EP 

2) Stronger Snare Tip 

3) Reduction of lD of sheath 1 French 

4) Ergonomic changes to the delivery systems. 

5) Color changes 

6) Improved migration resistance 

7) Improved tilt resistance 

8) Reduction of penetrations 

9) Anything else we want to consider for the project 

Thanks 

Mike 

PS..Attached is a copy of the last DIS used for G3 which we can use as a outline. 

ONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER 

MD1 RPVF-111_nnA1 777 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 2 of 105
Mt= G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 1 of 17 

Table of Contents 

Section Description 

1 Purpose 

2 Scope 

3 Information Sources 

4 Project Background Information 

5 Summary of Design Input 

Appendix A Bard Customer Vena Cava Filter Usage Study — Report of Fax Survey 

Appendix B Bariatric Surgeon Vena Cava Filter Usage Study — Report of Fax Survey 

Appendix C Multidisciplinary Panel Summary 

Appendix D Key Opinion Leader/High Volume User Panel — Panelist Profiles 

Appendix E Key Opinion Leader/High Volume User Panel - Meeting Summary 

Appendix F Field Visit Log 

Appendix G Clinical Literature 

Appendix H Complaint data 

Appendix I Regulatory Requirements 

1.0 Purpose 

This report documents and summarizes the design input information gathered during the 

concept phase of the G3 Vena Cava Filter project. This design input information is used 

to develop the Product Performance Specification (PPS), product design, and test plans. 

The business case for this project is outlined in Product Opportunity Appraisal POA-8049. 

2.0 Scope 

This design input summary applies to development of the G3 Vena Cava Filter. This report 

will document design input specific to the this product, as well as additional information 

related to actual use conditions and complaint data received on our currently marketed 

IVC Filters. 

3.0 Information Sources 

Design input information was gathered from multiple sources. These included the 

following: 

• Discussions with clinicians who perform ¡VC Filter placement and retrieval procedures 

• Focus group interviews with Interventional Radiologists, Trauma Surgeons, Bariatric 

Surgeons, Hematologists, Internal Medicine and Vascular Medicine specialists 

• Market Research Studies 

• Clinical Literature Review 

Confidential: This document contains information that is the confidential and proprietary property of C.R. Bard, Inc. Neither this document nor the information therein 

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_MD1 BPVE-01-00617777 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 3 of 105
[BMW G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 2 of 17 

• Complaint review 

• MAUDE website review 

• Regulatory requirements review 

4.0 Project Background Information 

BPV launched the Recovery Vena Cava Filter (RF-048F) with a permanent indication in 

April 2003, followed with the retrievable indication in October 2003. As the first IVC filter 

to receive a retrievable indication in the U.S., Recovery Filter brought a new level of 

awareness within the medical community to filter technologies and their associated 

complications. 

Traditionally, permanent filters were placed primarily in patients with documented 

thromboembolic disease and a contraindication to or complication with anticoagulation. 

These patients typically received a filter during their hospital course and then were never 

follow up specifically for the filter. With newer, retrievable filters, not only are more 

patients receiving filters, but they are being followed at a higher rate due to the intent to 

retrieve the filter. The implication of this updated follow up regimen is that more 

asymptomatic filter complications are being discovered than ever before. 

BPV discontinued the Recovery Filter in September 2005 and immediately replaced it with 

the G2 Filter (RF310F, RF210F), which has a permanent indication. As part of the routine 

passive post-market surveillance program, BPV began receiving reports of caudal 

migrations of the G2 Filter. Although the rate of caudal migration has always remained 

well below the reported rates in the SIR Quality Improvement Guidelines for IVC Filters, 

BPV undertook the effort to modify the design of the G2 Filter to improve its caudal 

migration resistance. 

5.0 Summary of Design Input 

Migration (both cranial and caudal) is a known and well-documented complication of vena 

caval filters. Although most agree that caudal migration is not the most serious of filter 

complications in terms of patient safety, it is nevertheless worrisome for most physicians 

when they encounter one of their patients with a filter that has migrated caudally. 

Numerous sources and methods were utilized to determine the design input for this 

project. The main goal of the efforts was to determine the expected and threshold 

complication rates for IVC Filters. Below is a summary of the information gathered from 

each input source. 

5.1 Literature Review 

5.1.1 A comprehensive review of the available literature revealed that although 

caudal migration is not the most serious of possible filter complications, 

some filters in history have undergone redesign efforts (Titanium 

Greenfield) or were discontinued entirely (Gunther) due to caudal migration. 

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LMD1 BPVE- 01-00617778 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 4 of 105
Recovery Gunther Tulip OptEase 

Bard) (Cook) (Cordis) 

Inability to retrieve 

Fdter migration 

Caval perforation 

Inadequate indwelling 1% 

Other 

113501D G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 3 of 17 

5.1.2 A secondary review of the available literature detailed the necessity of 

certain vena cava filter characteristics. These characteristics included (in 

no specific order): 

- Self-Centering and Tilt Resistance 

- No arm/leg entanglement (crossed limbs) 

- Efficient clot trapping 

- Caval patency 

Low profile 

- Extended retrievability 

- Easy retrieval 

Fracture resistance 

- Migration resistance 

Filter sized accordingly (one sized filter fits most vena cava) 

Ability to power inject 

- Accurate deployment 

Deployment with minimal force 

- Perforation 

The corresponding clinical literature is provided in Appendix G. 

5.2 Market Research Studies 

5.2.1 Bard Customer Surveys 

A survey of Bard customers regarding their IVC Filter utilization was conducted in Q1 

2005. Respondents were recruited by telephone and asked to fax back a 3-page 

questionnaire. A total of 154 surveys were completed and returned. 

One of the questions in the survey assessed the problems that users have had with 

various types of optional filters. The responses showed a trend toward a higher 

(perceived) rate of migrations, perforations, and filter tilt with Bard's filter than the 

Gunther Tulip (Cook) or the OptEase (Cordis). 

Q: Problems experienced with optional filters, by brand (n=154, multiple answers 

were accepted) 

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may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Bard. 

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LMD1 BPVE- 01- 00617779 

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G3 Vena Cava Filter DIS-8049 Er Design Input Summary Revision 001 

Report Page 4 of 17 

'None 43% 55% 73% 

5.2.2 Bariatric Surgeon Surveys 

Another survey was completed in Q1 2005 involving Bariatric Surgeons and their 

filter utilization. The aim of this study was to assess bariatric surgeons' awareness 

of IVC Filter technology and the possible risks and benefits associated with caval 

interruption. Respondents were once again recruited by telephone and asked to fax 

back a 4-page questionnaire. A total of 90 completed surveys were returned. 

One of the questions in this survey illustrated bariatric surgeons' general 

knowledge/perception of the types of complications that can occur with filters and 

how often: 

Q: How often do you observe the following complications due to IVC Filters In your 

patients? (n=90) 

<.1% >5% Do Not See 

(Less than 1% 5% (over 5/100) 

1/1,000) (1/100) (5/100). 

040090P.OP 

Caval Thrombosis 

PO4),'Pg 

34% 20% 9% 1% 

or 

36% 

Filter fracture 

rt.0 

43% 6% 1% 0% 50% 

The responses to the above question indicate that bariatric surgeons do and expect 

to see complications with filters. The majority expects to see these filter problems at 

a rate less than 1/1,000 cases. 

5.3 Focus Groups 

5.3.1 Multidisciplinary Panel 

In June 2004, BPV convened a multidisciplinary panel of physicians with specific 

expertise and/or interest in thromboembolic disease and IVC Filters to discuss filter 

complications. This panel discussed many issues including expected and 

threshold rates for various filter complications and possible causes for these filter 

problems. 

With regard to filter migration, the panel's perspective was the following. 

• It should occur less than 1% of time 

▪ 

For prophylactic filter placement, migration to the heart should virtually 

never happen. The rate should be less than 1 in 1,000. 

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LMD1 BPVE-01-00617780 

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krafarsa) G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 5 of 17 

• Migration should not be different for retrievable filters than for permanent 

filters. 

It should be noted, however, that this discussion was mainly about proximal (or 

cranial) migration. 

For caval perforations, the panel believed that symptomatic perforations should be 

less than 1% and that the rate of asymptomatic perforations does not matter. 

In summary, the multidisciplinary panel felt the following about general filter 

performance: 

• A retrievable filter is expected to perform just as well as a permanent 

filter. 

• A filter should not migrate; no matter what the size of thrombus burden it 

captures. 

5.3.2 Key Opinion Leader/High Volume User Panel 

BPV convened another panel in June 2006 to discuss caudal migration of filters, 

specifically the BPV experience to date with the G2 Filter. This panel included Key 

Opinion Leaders and High-Volume users of IVC Filters. The list of panelists along 

with their profiles is included as Appendix D. 

Below are some highlights of the discussion: 

IVC Perforation: 

• Could lead to erosion into duodenum, perforation of aorta, lodge in vertebral 

body 

• OK if asymptomatic, but could become symptomatic over time 

• 0 — 1% for "true" peforation; most perceived perfs are not "true" perforations 

• Belief there is strong correlation between tilting and perforation 

Migration (More than 2cm): 

• Concern when goes to heart/lungs or goes from infrarenal vs suprarenal or 

symptomatic migration or in combination with tilt/perforation 

• More concern over cephalad migration vs caudal migration 

• Theoretical concern if filter migrates caudally, since there is more space above 

filter in the IVC for thrombus formation (source for recurrent PE) 

BPV Experience: 

• Should focus on symptomatic complications — asymptomatic events probably 

occur at a much higher rate because underreported 

• At the time of the Expert Panel, there had been 3 symptomatic migrations in 

females: panelists thought these were coincidental in relation to small IVC 

diameter. Also, suggested females experience more abdominal & pelvic pain; 

therefore, may not be of real concern. 

• The panelists expressed concern over 3 suprarenal caudal migrations vs 4 

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may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Bard. 

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_MD1 BPVE-01-00617781 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 7 of 105
FRB/ iriD G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 6 of 17 

infrarenal that had been reported as of the date of the Panel. This does not 

represent actual placement practice: 100 infrarenals to 1 suprarenal. 

• Generally, believe most migrations occur early (first 2 weeks) due to healing 

process 

• Horizontal orientation: higher clot trapping efficiency may indicate higher risk of 

caval thrombosis and greater risk of pain due to stretching !VC 

• Felt reassured by BPV's due diligence with clot trapping study 

• Suggested IVC diameter may play role in caudal migration and tilting could lead 

to pain (symptomatic) in patients with smaller IVC due to stretching 

Summary of Concerns Expressed: 

▪ Inability to remove 

• "True" migrations 

• PE due to filter failure 

• Concern with caudal rates but not in relation to other filters 

Dr. Oliva Experience at CHUM: 

• Of 40 attempted retrievals 24 anticoagulation contraindicated. 8 need 

prolonged filtration. 

• 1 Caudal migration of 23 retrievals 

• 17% tilting, some associated with perforation/penetration 

• Retrieval window: 44 days (7 — 128) 

Potential Root Causes for Caudal Migration: 

• Believe most influential factor is caval dimensional changes 

• Watermelon seed affect 

• Small cava... more likely because arms may allow filter to ski down 

• Large cava... arms more likely to catch and prevent downward migration 

• Not much vessel spasm in IVC, but there is in small vessels 

5.4 Field Visits 

Numerous field visits were conducted by BPV sales, marketing, and R&D to 

respond to questions regarding various filter issues, including caudal migrations. 

These visits were also utilized to gather information regarding users' expected and 

threshold rates of various filter complications. 

The main message that came out of the clinical interviews conducted during field 

visits is that users who have experienced caudal migrations of the G2 Filter are 

generally unhappy with the rate of this failure mode they are seeing. The users' 

perceived rate of caudal migrations seem to have a strong positive relationship 

with retrieval rate, as can be seen in the below table, which is a representative 

depiction of the general opinion based on utilization and retrieval rate. 

Physician Hospital Annual 

Utilization 

Retrieval 

Rate 

Perceived 

caudal 

migration rate 

(G2 Filter) 

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may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Bard. 

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_MD1 BPVE-01-00617782 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 8 of 105
[Bas: G3 Vena Cava Filter 

Design Input Summary 

Report 

DIS-8049 

Revision 001 

Page 7 of 17 

Frank Lynch, MD Hershey Penn State 

Hershey, PA 200 — 250 units 50% 30% 

Mamood Razavi, MD St Joseph's Hospital 

Orange, CA 50 — 75 units 15% 1% 

Bruce Zweibel, MD Tampa General Hospital 

Tampa, FL 150 —200 units >5% 0% 

Although most physicians believe that caudal migration has less serious patient 

safety implications than some other types of filter complications, they believe that a 

filter that moved caudally implies a general instability of the device in situ and 

therefore felt less comfortable using it as their default filter. 

A summary of the field visit log, along with a justification of which of these design 

inputs will or will not be pursued as part of the G3 Filter project is located in 

Appendix F. 

5.5 Complaint analysis 

A thorough review of all received internal filter complaints was completed by 

conducting a search within Trackwise (BPV's internal complaint tracking software) 

by FDA code for both the currently marketed filter devices (Simon Nitinol Filter, G2 

Filter, and Recovery Cone), as well as historically marketed filter devices 

(Recovery Filter). A detailed list of all complaints, shown by FDA code is shown in 

Appendix H. In summary, the top five complaints as of July 31, 2007 for each filter 

product are shown in the table below. 

Filter 

Type 

Top Five Reported Complaints 

#1 #2 #3 #4 #5 

SNF 

Difficult to 

Deploy 

(QTY: 41) 

Failure to 

Deploy 

(QTY: 26) 

Twisting 

(QTY: 19) 

Dome 

Collapse 

(QTY: 10) 

Detachment of 

Components 

(QTY: 7) 

Recovery 

Detachment of 

Components 

(QTY: 123) 

Migration* 

(QTY: 61) 

Difficult to 

Deploy 

(QTY: 31) 

Twisting 

(QTY: 31) 

Perforation 

(QTY: 29) 

G2 

Femoral 

Difficult to 

Deploy 

(QTY: 99) 

Failure to 

Deploy 

(QTY: 73) 

Migration** 

(QTY: 45) 

Misplacement 

(QTY: 25) 

Missing 

Components 

(QTY: 18) 

G2 

Jugular 

Migration*** 

(QTY: 17) 

Other 

(QTY: 7) 

Broken 

Components 

(QTY: 5) 

Twisting 

(QTY: 4) 

Perforation 

(QTY: 4) 

Recovery

Cone 

Detachment of 

Components 

(QTY: 26) 

Broken 

Components 

(QTY: 7) 

Bend 

(QTY: 4) 

Failure to 

Capture 

(QTY: 4) 

Other 

(QTY: 4) 

*The majority of these migrations were in the cranial direction 

"*37 of these migrations were caudal, 8 were cranial 

***Al! of these migrations were in the caudal direction 

****Typically 'other' encompasses tilt and delayed opening 

As well, a review of the MAUDE database was conducted, comparing the 

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may be reproduced, used or distributed to or for the benefit of any third party without prior written consent of Bard. 

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_MD1 BPVE-01-00617783 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 9 of 105
G3 Vena Cava Filter 

Design Input Summary 

Report 

complaint rates of all commercially available filters against the SIR Guidelines. It is 

important to keep in mind that companies are only liable for reporting medical 

device reports (MDRs) for those complaints that they determine could or have 

caused patient injury. Each company uses their own internal standards for making 

this determination, thus, there potentially exists a wide range of discrepancy from 

company to company on what complaints are reported to the FDA. A summary of 

the MAUDE database findings, as well as a ranking by company for each 

complaint type are provided in Appendix H. 

5.6 Current Regulation Review 

A review of the following regulations was completed: 

- Guidance for Cardiovascular Intravascular Filter 510(k) Submissions, 

November 26, 1999 

- Smith, Angela. Regulation of Peripheral Vascular Devices: Current issues in 

the regulation of IVC filters. Endovascular Today; Nov. 2005: 93-94 

Shelf Life of Medical Devices, April 1991 

Sterile, single-use intravascular catheters, IS010555-1:1995 

Non-active surgical implants – General Requirements, IS014630:1997 

Non-active surgical implants – Particular requirements for cardiac and vascular 

implants; Part 3: Endovascular devices, EN12006-3:1999 

From this review, many additional regulatory requirements were identified, 

including, but not limited to: biocompatibility, simulated deployment, 

introducer/sheath suitability, clot trapping ability, filter fracture, caval perforation 

filter migration, thrombogenicity, MRI compatibility, and many more. The detailed 

requirements can be found in Appendix I. 

Description of Change— 

Revision number Chan es 

000 Original/J.Hudnall 

001 Updated project name from Tetra to G3 

throughout, updated Appendix F to include 

rationale for user needs, changed document 

number from TD-00395 to DIS-8049/S.Klocke 

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LMD1 BPVE- 01- 00617784 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 10 of 105
G3 Vena Cava Filter 

Design Input Summary 

Report 

Appendix A 

Vena Cava Filter Usage Study 

Among Bard Customers 

Final Report 

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LMD1 BPVE-01-00617785 

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1:BL G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 10 of 17 

Appendix B 

Vena Cava Filter Usage Study 

Among Bariatric Surgeons 

Final Report 

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_MD1 BPVE- 01- 00617786 

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[Rap G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 11 of 17 

Appendix C 

Multidisciplinary Panel 

Summary Report 

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_MD1 BPVE-01-00617787 

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MIMED G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 12 of 17 

Appendix D 

Key Opinion Leader/High-Volume User Panel 

Panelist Profile 

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_MD1 BPVE- 01- 00617788 

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G3 Vena Cava Filter DIS-8049 

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Report Page 13 of 17 

LB 

Appendix E 

Key Opinion Leader/High Volume User Panel 

Meeting Summary 

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_MD1 BPVE-01-00617789 

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WIRT G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 14 of 17 

Appendix F 

Field Visit Log 

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_MD1 BPVE-01-00617790 

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G3 Vena Cava Filter D1S-8049 

Design Input Summary Revision 001 

Report Page 15 of 17 

Appendix G 

Clinical Literature 

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LMD1 BPVE-01-00617791 

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G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 16 of 17 

nwf, 

Appendix H 

Complaint Data 

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_MD1 BPVE-01-00617792 

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0351TID G3 Vena Cava Filter DIS-8049 

Design Input Summary Revision 001 

Report Page 17 of 17 

Appendix I 

Regulatory Requirements 

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LMD1 BPVE-01-00617793 

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EXHIBIT 113

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 20 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 1

 SUPERIOR COURT OF CALIFORNIA

COUNTY OF SAN DIEGO, EAST COUNTY REGIONAL CENTER

 - - -

MARY GIORDANO, individually :

and on Behalf of the Estate :

of Jacqueline Keith and :

other qualified survivors, :

 Plaintiffs, :

 : Case No. 37-2011-

 vs. : 00069363-CU-PO-EC

 :

C.R. BARD, INC., a :

corporation, BARD PERIPHERAL :

VASCULAR INC., a corporation,:

THOMAS BRANNIGAN, M.D., an :

individual, FRANKLIN KALMAR, :

M.D., an individual, JULIE :

LAIDIG, M.D., an individual, :

SHARP GROSSMONT HOSPITAL, a :

corporation, SHARP :

HEALTHCARE, a corporation, :

and DOES 1 through 100 :

inclusive, :

 Defendants. :

 - - -

 Tuesday, November 12, 2013

 - - -

 Videotaped Deposition of DAVID

CIAVARELLA, M.D., held at Short Hills Hilton, 41

John F. Kennedy Parkway, Short Hills, New

Jersey, on the above date, beginning at 9:43 a.m., 

before Kimberly A. Overwise, a Certified

Realtime Reporter and Notary Public.

 - - -

 GOLKOW TECHNOLOGIES, INC.

 877.370.3377 ph|917.591.5672 fax

 deps@golkow.com

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 21 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 130

1 BY MR. LOPEZ:

2 Q Well, are you aware that there was

3 a -- do you keep up with the literature when it

4 comes to things like that?

5 A I wouldn't say aggressively.

6 Q Okay. I'm going to -- I think if you

7 look at the recent literature for this year,

8 there's an article written in a peer-reviewed

9 journal that has done research and has done an

10 analysis of this so-called Webber effect, and

11 the conclusion was there is no Webber effect.

12 You haven't read that article?

13 A No.

14 Q Okay. And -- but, in any event,

15 whether that article's valid or not valid or

16 whether it trumps every other article that talks

17 about Webber effect, the truth is in 2004 it was

18 well known in -- at Bard and in the industry

19 even when you were at J&J that you're only

20 seeing the tip of the iceberg when you're

21 dealing with voluntary reporting from clinicians

22 when it comes to adverse events; right?

23 MS. DALY: Object to form.

24 THE WITNESS: I don't know if I'd

25 call it the tip of the iceberg.

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 22 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 131

1 BY MR. LOPEZ:

2 Q Well, the tip of the ice -- what if

3 it's -- what if you're right, it's 1 percent to

4 5 percent you're only getting?

5 A I don't know.

6 Q Okay. But there's a general consensus

7 that that might be, in fact, the case, you're

8 only getting 1 to 5 percent of what's actually

9 happening, actually reported to the company or

10 FDA?

11 A I mean, maybe yes, maybe no. That's

12 the problem with it is you don't know.

13 Q But it --

14 A You could make an estimate, but an

15 estimate's an estimate.

16 Q Right. But there was at one point in

17 time -- I can show you the document later --

18 where you, Dr. Ciavarella, said one of the

19 problems with reporting of events, voluntary

20 reporting, is there's a consensus that you might

21 be only getting 1 to 5 percent of the actual

22 events; right?

23 A Could be. Yeah, there's a consensus.

24 Q So when -- in April -- I mean -- I'm

25 sorry. Yeah, in April of 2004 when you're

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 23 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 220

1 Q No. I asked you based on the

2 regulatory guideline -- regulatory protocol

3 document that we marked earlier and the

4 regulations that deal with adulterated products

5 and misbranded products and recall, whether any

6 of these rates now put us in a category where

7 it's unacceptable, unexpected, unintended where

8 recall should be considered?

9 MS. DALY: Object to the form.

10 THE WITNESS: I don't know

11 because that's a decision made by Chris

12 Ganser and his team and the quality

13 assurance and the regulatory people. So I

14 don't know how he applied it.

15 BY MR. LOPEZ:

16 Q And since you brought it up, I'm glad

17 you agree with me that Dr. Grassi and the SIR

18 don't control what are acceptable and

19 unacceptable risks with respect to what should

20 be warned about whether or not a product is

21 properly designed or not designed or whether or

22 not it should be recalled. You agree with me;

23 right?

24 A I do.

25 Q And with respect to the Grassi

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 24 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 221

1 article, we're talking about the one in 2001?

2 A Yes.

3 Q And have you ever read the references

4 to that article?

5 A I know I read some of them, but I

6 can't recall if I've read all of them. It was

7 some time ago.

8 Q And do you know what vintage of device

9 those statistics are dealing with?

10 A Well, you know, the article was

11 published that long ago, 2001. That was before

12 the general category of retrievable filters was

13 introduced in the marketplace. So it was

14 largely the first and second generation of

15 permanent filters probably.

16 Q You don't know?

17 A Well, I don't remember exactly.

18 That's what I would guess.

19 Q Well, I mean, there are -- how many of

20 the deaths that are referenced in the Grassi

21 article are actually related to anything to do

22 with a device malfunction?

23 A Yeah, I just don't remember. I think

24 it would be a function of how transparent the

25 article was that they were basing this, if they

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 25 of 105
David Ciavarella, M.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 374

1 Point -- Bullet Point 2, "Lack of thorough

2 understanding dynamics of caval anatomy -

3 impacting testing methods," what does that mean?

4 A Well, what it says, that understanding

5 what happens to the vena cava during everyday

6 activities and things is very poorly understood.

7 So if we're trying to develop bench testing

8 methods that would simulate an in vivo

9 situation, it's very difficult to do that

10 because we really don't have any good models or

11 understanding of what happens to the cava.

12 Q Okay. This is the company's -- this

13 is talking about the company itself has the lack

14 of thorough understanding?

15 A Well, you can look --

16 Q Because the company can't speak --

17 A You can look at it as the company

18 doesn't understand or you can look at it as

19 nobody understands it. The thorough

20 understanding of the dynamics of caval anatomy

21 is something that's not well known -- not well

22 understood.

23 Q Well -- well, okay. I mean, are you

24 speaking from a position of having -- of

25 authority meaning you've studied this, you've

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 26 of 105
EXHIBIT 116 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 27 of 105
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 TIMOTHY A. FISCHER

 12

 TAKEN AT: Quarles & Brady

 13 LOCATED AT: 411 East Wisconsin Avenue

 Milwaukee, WI

 14

 March 29, 2017

 15 8:38 a.m. to 3:08 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 8375-5 Filed 10/23/17 Page 28 of 105
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 7

 1 A. Yes.

 2 Q. Where were you working?

 3 A. E-Health Technologies.

 4 Q. And what type of company is that?

 5 A. Medical record retrieval company.

 6 Q. What was your position?

 7 A. Director of sales, and then vice

 8 president of sales and general manager of

 9 operations.

 10 Q. Did you live in Rochester, New York at

 11 that time?

 12 A. No, I lived where I live now.

 13 Q. Did you have a sales territory?

 14 A. I ran sales. I had salespeople reporting

 15 to me.

 16 Q. And then where you worked before that was

 17 C.R. Bard; is that right?

 18 A. Correct.

 19 Q. According to your resumé, you worked

 20 there from 2000 to 2006?

 21 A. Correct.

 22 Q. What was your position?

 23 A. Territory manager and then field sales

 24 manager.

 25 Q. Tell me about your education background.

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 29 of 105
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 281

 1 THE WITNESS: I'm not aware of that, no.

 2 BY MR. O'CONNOR:

 3 Q. And what you told us today is that you

 4 were a sales representative and you still are, and

 5 somebody that believed patient safety had to be

 6 first and foremost; right?

 7 A. I was a sales representative, I believe.

 8 I'm not a sales representative anymore, but --

 9 Q. All right. Thank you. But at the time

 10 though, you believed, and your goal was patient

 11 safety; right?

 12 A. Yes.

 13 Q. And that's why when we showed you a lot

 14 of these documents that you've never seen before

 15 today, the numbers you saw, the events you saw

 16 about the Recovery filter, were concerning to you;

 17 correct?

 18 MR. LERNER: Objection to form.

 19 THE WITNESS: Yeah, I think -- I think

 20 the -- the amount of documents with the numbers

 21 were -- were -- took me a little off guard, so to

 22 speak.

 23 BY MR. O'CONNOR:

 24 Q. And again, you were not provided that

 25 information by Bard back at the time that you were

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Golkow Technologies, Inc. Page 282

 1 addressing doctors and promoting Bard products;

 2 correct?

 3 A. I don't believe I was, no.

 4 Q. And this is the type of information that

 5 you wished you would have had, true?

 6 A. I think if -- so I'm not going to lump

 7 the MAUDE database stuff in there, but I think if

 8 there is -- there is good clinical information

 9 that -- that was available, I would have wanted to

 10 present that to my physicians.

 11 Q. Well, what you would do if you had a

 12 MAUDE database information that was verified by

 13 complaint files and other information, certainly

 14 that would help you understand the validity of the

 15 event recorded; right?

 16 A. I would not have wanted to present any

 17 MAUDE database information to my physicians because

 18 it's not something that they hold as valuable.

 19 Q. Different question. If Bard felt it was

 20 important enough to record that information and

 21 those events in weekly reports, that information

 22 was important enough to supply to you so you could

 23 have it knowing about your filter; right?

 24 A. Yeah. So once they tracked it and did

 25 their announcements on it, if they thought it was

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Golkow Technologies, Inc. Page 283

 1 important, I would have wanted to have it, yes.

 2 Q. And they didn't give it to you, did they?

 3 A. They did not.

 4 MR. O'CONNOR: Give me two minutes. I

 5 want to make sure I don't have anything else.

 6 MR. LERNER: Okay.

 7 THE VIDEOGRAPHER: Going off the record

 8 at 3:06.

 9 (Break taken.)

 10 THE VIDEOGRAPHER: We're back on the

 11 record at 3:08.

 12 MR. O'CONNOR: All right. Mr. Fischer, I

 13 don't have any more questions. Thank you for your

 14 time today.

 15 THE WITNESS: Thank you.

 16 THE VIDEOGRAPHER: Going off the record

 17 at 3:08. Media four of four. End of deposition.

 18

 19

 20

 21

 22

 23

 24

 25

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 32 of 105
EXHIBIT 117 

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 33 of 105
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 1

 1 IN THE UNITED STATES DISTRICT COURT

 2 FOR THE DISTRICT OF ARIZONA

 3 - - -

 4

 IN RE: BARD IVC :

 5 FILTERS PRODUCTS : NO.

 LIABILITY LITIGATION : MD-15-02641-

 6 : PHX-DGC

 :

 7 :

 8 - - -

 9 July 18, 2017

 10 - - -

 11

 12 DO NOT DISCLOSE - SUBJECT TO FURTHER

 13 CONFIDENTIALITY REVIEW

 14

 Videotaped deposition of

 15 MARK W. MORITZ, M.D., taken pursuant to

 notice, was held at the offices McCarter

 16 & English, LLP, 100 Mulberry Street,

 Newark, New Jersey, beginning at 9:07

 17 a.m., on the above date, before Michelle

 L. Gray, a Registered Professional

 18 Reporter, Certified Shorthand Reporter,

 Certified Realtime Reporter, and Notary

 19 Public.

 20

 - - -

 21

 22 GOLKOW LITIGATION SERVICES

 877.370.3377 ph | 917.591.5672 fax

 23 deps@golkow.com

 24

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 34 of 105
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 85

 1 Q. Failures of Bard filters

 2 include tilting?

 3 A. Correct.

 4 Q. Failure of Bard filters

 5 include fracture?

 6 A. Yes.

 7 Q. Embolization?

 8 A. Yes.

 9 Q. And failures also include

 10 penetration into other organs, correct?

 11 A. Correct.

 12 Q. And you have seen at least

 13 in reviewing the plaintiff experts that

 14 there were internal documents in Bard

 15 which spoke to serious injuries, and even

 16 death caused by failure modes of Bard

 17 filters?

 18 A. Correct.

 19 Q. And certainly that's

 20 something I think you would agree that a

 21 medical doctor would want to know from a

 22 medical device company in making

 23 decisions about which type of devices to

 24 use for patients, fair?

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 35 of 105
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 86

 1 MR. BROWN: Object to the

 2 form.

 3 THE WITNESS: Yes.

 4 BY MR. O'CONNOR:

 5 Q. And certainly from what

 6 you've told me before, you certainly

 7 cannot discuss what if anything Bard did

 8 by way of warning of its knowledge of the

 9 types of filters and complications that

 10 Bard became aware of, true?

 11 A. Well, I remember a letter

 12 around 2005 that I think I got.

 13 Q. All right. So you got some

 14 kind of "Dear Colleague" or "Dear Doctor"

 15 letter?

 16 A. "Dear Doctor" letter.

 17 Q. You're not going to be

 18 talking about that letter in this trial,

 19 fair?

 20 MR. BROWN: Object to the

 21 form.

 22 THE WITNESS: No, I didn't

 23 intend to.

 24

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 36 of 105
EXHIBIT 118 

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Exhibit H-G

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 51 of 105
Page 1

 IN THE UNITED STATES DISTRICT COURT

 FOR THE DISTRICT OF ARIZONA

 _ _ _

 :

IN RE: BARD IVC FILTERS :No. MD-15-02641-PHX-DGC

PRODUCTS LIABILITY LITIGATION :

 :

------------------------------

 - - -

 OCTOBER 11, 2016

 - - -

 DO NOT DISCLOSE - SUBJECT TO FURTHER

 CONFIDENTIALITY REVIEW

 Videotaped deposition of CHRISTOPHER 

 D. GANSER, held at HILTON SHORT HILLS,

 41 John F. Kennedy Parkway, Short Hills, New

 Jersey, commencing at 9:32 a.m., before

 Margaret M. Reihl, a Registered Professional

 Reporter, Certified Realtime Reporter, and

 Notary Public.

 GOLKOW TECHNOLOGIES, INC.

 877.370.3377 ph | 917.591.5672 fax

 deps@golkow.com

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 52 of 105
Page 301

1 Q. And it knew that it had an undesirable

2 risk profile based on its own R002 that Dr. -- from

3 Dr. Ciavarella's February 2006 HHE?

4 MS. DALY: Object to form.

5 BY MR. LOPEZ:

6 Q. Undesirable?

7 A. It was rated undesirable per the

8 remedial action plan process.

9 Q. Yeah, and it was obviously rated as

10 something that needed to be redesigned to deal with

11 that -- those undesirable complications, true?

12 A. It needed to be addressed.

13 Q. Well, it needed to be redesigned, right?

14 MS. DALY: Object to the form.

15 BY MR. LOPEZ:

16 Q. There were some defects in the design of

17 the G2 that was leading to the problems described in

18 Dr. Civarella's February 2006 HHE; don't you agree,

19 sir?

20 A. There were issues with the design that

21 needed to be addressed.

22 MS. DALY: Ramon, can I interrupt you

23 just a moment. I did not realize this, and you

24 did not realize this, but the stipulation about

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 53 of 105
Exhibit H-H

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 54 of 105
Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 1

 IN THE UNITED STATES DISTRICT COURT

 IN THE SOUTHERN DISTRICT OF FLORIDA

SAMANTHA BOULDRY, ELUA HUFF, )

SANDRA LORENZ, and JANET ROBERTS, )

on behalf of themselves and the )

class of all others similarly )

situated, ) Case No:

 ) 12-80951-

 Plaintiffs, ) CIV-ROSENBAUM

vs. )

 )

C. R. BARD, INC., a corporation of )

the State of New Jersey, and BARD )

PERIPHERAL VASCULAR, INC., a )

corporation of the State of )

Arizona, et al., )

 )

 Defendants. )

__________________________________ )

 CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER

 DEPOSITION OF ROBERT MICHAEL CARR, JR.

 Phoenix, Arizona

 April 17, 2013

 BY: KARLA M. MARTIN, RPR, CSR

 Arizona CR No. 50485

 GOLKOW TECHNOLOGIES, INC.

 877.370.3377 ph | 917.591.5672 fax

 deps@golkow.com

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 55 of 105
Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 32

1 identify a customer need with respect to tracking?

2 A. To enable more filters to be removed, yes.

3 Q. Okay. And explain how it is that tracking would

4 enable the removal of more filters.

5 A. I don't know in particular in these cases. But

6 oftentimes patients are lost to follow-up. They just move

7 out of the system; or practices are busy, and they don't

8 have the wherewithal to manage each and every patient,

9 reminder phone call or whatever it may be.

10 Q. Before we move further down this road, with

11 respect to the Recovery filter, it is a -- and let me get

12 it right -- it is or was designed to act as a permanent

13 filter, but when clinically indicated may be

14 percutaneously removed after implantation according to the

15 instructions provided under the removal procedures; is

16 that correct?

17 A. Absolutely.

18 Q. All right. So it's first a permanent device that

19 may be removed; is that correct?

20 A. Yes.

21 Q. All right. And that is true for the G2, as well

22 as the G2 Express. Am I correct?

23 A. Yes.

24 Q. Do you know whether this customer issue or need

25 went anywhere; that is, was there a tracking program that

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 56 of 105
Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 41

1 A. No. It's empty.

2 Q. What is in the database?

3 A. Empty cells and address blocks and places for

4 people to enter their information.

5 Q. Okay. Did Bard send out an informational letter,

6 a Dear Doctor letter, anything of that nature, informing

7 other physicians or hospitals about the existence of this

8 database?

9 A. I don't know.

10 Q. What was the purpose of the database from your

11 perspective?

12 MR. BORANIAN: I object to the form.

13 A. For Dr. Lynch to keep track of his patients.

14 Q. Was the database provided to any other physicians

15 other than Dr. Lynch or other hospitals, for example?

16 A. Dr. Lynch created the database for himself. As I

17 said, we provided the software to those who wanted it.

18 Q. But was the database shared with anyone other

19 than Dr. Lynch?

20 A. It wasn't shared with anyone. No data was

21 shared.

22 Q. All right. It was for Dr. Lynch's use only?

23 A. Yes.

24 Q. And to your knowledge, the existence of this

25 database was not made known to other physicians or

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 57 of 105
Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 94

1 Q. And how would this anchoring system reduce

2 tilting of the filter?

3 A. If the filter can't move, it can't tilt.

4 Q. All right. And was the clinical data indicating

5 that filters, the G2 and the G2 Express, were being

6 placed, they were centered properly, but at some point

7 there was an indication that some of these filters were

8 tilting within the vena cava?

9 A. Whether they were placed tilted or centered, yes,

10 there were reports of tilt post placement.

11 Q. But my question is a little more specific than

12 that. It relates to those patients that were implanted

13 with a filter, the filter was centrally placed in the vena

14 cava.

15 A. Yes.

16 Q. Was there clinical data indicating that the G2

17 and the G2 Express were subsequently tilting after

18 placement?

19 A. Yes.

20 Q. All right. And what's the significance when a

21 filter tilts within the vena cava?

22 A. Usually nothing. But sometimes it can make it

23 not retrievable. And as I alluded to before, it can cause

24 it to penetrate or lead to a penetration.

25 Q. What about fracture?

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Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 95

1 A. Changing the stresses on the filter changes the

2 stresses applied. So it could lead to fracture.

3 Q. All right. And this tilting phenomenon, if the

4 G2 and/or the G2 Express were centrally placed, this

5 tilting is, based on what I am reading here, related to

6 the anchoring system, as opposed to individual patient

7 factors. Agreed?

8 A. No. It's related to both.

9 Q. What were the -- what are the individual patient

10 factors?

11 A. As I alluded to before, Valsalva, quad coughs,

12 clot, increases in blood volume, surgery. There's all

13 kinds of things that can affect or cause tilt.

14 Q. There's all sorts of potential hypothetical

15 situations that can cause tilt. But what from Bard's

16 standpoint was the realistic, day-to-day concern that was

17 causing tilt to occur?

18 A. All of those things that I mentioned are the

19 day-to-day concerns of what causes tilt; and therefore,

20 our solution was, if we could stop the filter from being

21 able to move or be tilted, then that's what we would do.

22 Q. So the thought was by changing the anchor system

23 Bard could prevent the filter from tilting, if there's a

24 cough by the patient, if there's a Valsalva maneuver, if

25 the patient has changes in blood volume, if there is clot

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 59 of 105
Confidential - Subject to Protective Order

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 96

1 that forms at or around the filter. Am I correct?

2 A. Reduce the number.

3 Q. All right. So Bard was of the view that if we

4 change the anchoring system, these known or these

5 thought-to-be causes for tilt would be reduced?

6 A. Yes.

7 Q. Feel free to review the entirety of Exhibit 7.

8 When this document references the causes for tilt and

9 fracture and penetration, let me know where in this

10 document it mentions any individual patient

11 characteristics that may potentially be causing these

12 problems.

13 A. It wouldn't, but nor would it be expected to.

14 Q. Well, the reality is the IFU doesn't say if a

15 patient coughs too much or if there's a Valsalva maneuver

16 that these complications increase, does it?

17 A. The DFMEA does, which is the proper place to

18 identify those risks and mitigations.

19 Q. What is the DFMA (sic)?

20 A. The DFMEA is the design failure modes and effects

21 analysis.

22 Q. Who does Bard share that with?

23 A. The FDA.

24 Q. Is it provided to the physicians who are

25 implanting these devices?

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 60 of 105
Exhibit H-J

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 61 of 105
Donna Beatrice Tillman, Ph.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 1

 IN THE SUPERIOR COURT OF THE STATE OF ARIZONA

 IN AND FOR THE COUNTY OF MARICOPA

-------------------------------------x

TINA BARKLEY and JEFFERY BARKLEY,

individually and as husband and wife,

 Plaintiffs,

v. No. CV2011-021250

C.R. BARD, INC, et al.,

 Defendants.

-------------------------------------x

 IN THE UNITED STATES DISTRICT COURT

 DISTRICT OF NEVADA

------------------------------x

KEVIN PHILLIPS,

 Plaintiff,

vs. Civil Action No.:

 3:12-cv-00344-RCJ-WGC

C.R. BARD, INC., et al.,

 Defendants.

------------------------------x

 IN THE SUPERIOR COURT OF THE STATE OF ARIZONA

 IN AND FOR THE COUNTY OF MARICOPA

-----------------------------------x

MELANIE RACKLIFF, an individual,

 Plaintiff,

v. NO. CV2011-021206

C.R. BARD, INC., et al.,

 Defendants.

-----------------------------------x

 Deposition of DONNA BEATRICE TILLMAN, Ph.D.

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 62 of 105
Donna Beatrice Tillman, Ph.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 193

1 more consistently reported for one device versus

2 another. There is just a lot of variability.

3 Q. All right. That was a rude

4 answer, because you didn't answer my question.

5 MR. ROGERS: Object. Ramon, stop

6 trying to argue and harass the witness,

7 please.

8 MR. LOPEZ: That was a rude answer

9 because I didn't ask her that. That's

10 being rude.

11 MR. ROGERS: Well, I don't

12 appreciate you speaking to the witness

13 that way.

14 MR. LOPEZ: All right. Well, I

15 don't appreciate the witness continuously

16 ducking questions.

17 MR. ROGERS: The witness is not

18 ducking questions. The witness is

19 answering your questions.

20 Q. The question is simple, are you

21 aware of any evidence to suggest that physicians

22 are more likely to report the same or similar

23 adverse event of a particular medical device's --

24 to a particular medical device company over some

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 63 of 105
Donna Beatrice Tillman, Ph.D.

Golkow Technologies, Inc. - 1.877.370.DEPS

Page 194

1 other company?

2 A. I am aware, and I can't -- I'm not

3 going to be able to put my finger on it, of

4 studies that have been done that show that

5 medical device reporting can be subject to a host

6 of inaccuracies, which include different device

7 types, and may include -- you know, I don't think

8 it would include companies, but there are reasons

9 why that. So that's the best I can answer your

10 question.

11 Q. Okay. Let me ask this question:

12 Are you aware of any data that would suggest in

13 any way that physicians are more likely to report

14 embolization deaths of an inferior vena cava to

15 one manufacturer over another manufacturer?

16 A. I am not aware of any data like

17 that.

18 Q. Wouldn't you agree, ma'am, just

19 having been in this world for as long as you've

20 been in the pharmaceutical medical device

21 regulatory world, that if a device causes a death

22 or is associated with a death in some fashion

23 that a physician is as likely to report it, in

24 any event, regardless of who the manufacturer is?

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Deposition of:

Thomas Kinney , M.D.

June 17, 2017

In the Matter of:

In Re: Bard IVC Filters Products

Liability

Veritext Legal Solutions

1075 Peachtree St. NE , Suite 3625

Atlanta, GA, 30309

800.808.4958 | calendar-atl@veritext.com | 770.343.9696

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 87 of 105
Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 Q. Okay. How about post-market adverse event

2 tracking?

3 A. I think I can understand that. I don't -- I am

4 not an expert. No one would say -- no one would look in

5 the Yellow Pages, if people still do that, and say, you

6 know, that's for the expert Dr. Kinney under there. But

7 basically, the analysis that a physician does or an

8 engineer does, I think you can -- I think you can have

9 some insight there.

10 Q. But other than this lawsuit, you don't have any

11 education, training, or experience in post-market adverse

12 event tracking?

13 MR. JOHNSON: Form objection.

14 Also vague and overbroad.

15 BY MR. BROWN:

16 Q. Is that fair?

17 A. No specific training, no.

18 Q. Do you consider yourself an expert in what might

19 constitute a safety signal for a medical device?

20 MR. LOPEZ: Form.

21 THE WITNESS: I wouldn't say I'm an expert, but

22 I'm a physician. So we do procedures on people, and we

23 get signals all the time about what's working and what's

24 not working; and if we don't listen to those signals,

25 people get hurt very bad sometimes and including

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 Q. I don't know. You said it. That's why I wanted

2 to ask you about it.

3 A. They said they were going to do a study.

4 Q. Do you remember who told you that they were

5 going to do a study?

6 A. I remember Janet Hudnall saying that. I don't

7 know if Rob Carr said it also. I don't remember.

8 Q. Did Janet Hudnall and Rob Carr tell you that

9 they were going to do -- not they -- that Bard was going

10 to do a long-term study of the Recovery filter?

11 A. Yes.

12 Q. Do you remember when that occurred?

13 A. It would have been between 2004 and probably

14 2005 or '6. I think it was about the time we were doing

15 those animal evaluations to come up with a G2.

16 Q. Do you have any idea about the specifics of the

17 study that they were telling you was going to be

18 performed?

19 A. There wasn't no specifics, but there was -- it

20 was going to be a long-term evaluation.

21 Q. Do you have any knowledge about what happened at

22 Bard as far as that long-term study of the Recovery

23 filter?

24 A. Not specifically. But it seems like they ended

25 up -- you know, it kind of evolved into like the Everest

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 study, which is really just -- again, it became a

2 short-term retrieval study for the G2, which to me, when I

3 review that, there were some signals in even that

4 short-term study that again begged the question that we

5 really need a long-term study to have factual data that we

6 could really talk to patients about the risk and benefits

7 of the Bard -- the new generation Bard filter.

8 I mean, it was -- it was labeled to us as this was

9 the only filter we were going to need. It had, you know,

10 you know, unsurpassed fracture resistance and positional

11 stability. And, you know, we hear those things, and we

12 believe those things, and then you start finding out that

13 that's not true and, you know, it kind of voids -- voids

14 all the honesty and transparency things that are so

15 important when we talk to patients about consent and

16 trying to tell a patient about what that particular

17 complication means for them, and why they are -- they are

18 subjected to that or the anxiety of that, all that stuff.

19 Q. You mentioned the Everest study, which was a

20 six-month study for the G2 filters; is that right?

21 MR. JOHNSON: Form.

22 THE WITNESS: Correct.

23 BY MR. BROWN:

24 Q. And then you said that you envisioned that there

25 would be a long-term study; right?

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 consent to their patients."

2 Do you see that?

3 A. I do.

4 Q. Is it your opinion that physicians should

5 receive all bench testing for medical devices that they

6 use?

7 MR. JOHNSON: Form.

8 THE WITNESS: Most -- Most physicians don't.

9 They don't want to know bench testing, but they do want to

10 know when the -- you know, that there's data that shows

11 that a company has been tracking data that shows

12 statistically that it had higher rates of perforations,

13 migrations, fractures, and they are not notified.

14 BY MR. BROWN:

15 Q. Okay. We'll get to that in a second, but I just

16 want to focus on everything that you're saying --

17 A. Okay.

18 Q. -- that physicians should receive.

19 So as far as the bench testing, you're not saying

20 that physicians should receive all bench testing?

21 MR. JOHNSON: Just note my objection. The

22 question has been asked and answered. Paragraph 8 doesn't

23 even mention bench testing, so I don't understand the

24 question.

25 BY MR. BROWN:

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 Q. Do you understand the question, Doctor?

2 A. Yeah, it's asking about performance. So

3 performance to me is the important clinical parameters,

4 like recurrent pulmonary embolism, issues about

5 perforations, migrations, fractures, those are

6 recurrent -- DVT, caval thrombosis. I think those are

7 performance issues that physicians would want to know.

8 For instance, if they had trouble deploying the filter, I

9 think it's probably important for physicians to know.

10 I don't -- They are not going to want to know, you

11 know, migration tests or pole tests. I might be

12 interested because I'm a strange person, I suppose, but I

13 think most clinicians would not want to know.

14 Q. So what you're referring to in Subparagraph A

15 relates to the clinical information? In other words, the

16 adverse events that are actually occurring in people; is

17 that right?

18 MR. JOHNSON: Objection. Form.

19 THE WITNESS: Yeah, yeah. I mean, this gets

20 gray for me because suppose there's animal models that you

21 think are good animal models, and they show issues, that

22 becomes maybe important. That may become important. But

23 I think as a general, what you are saying is true, but --

24 BY MR. BROWN:

25 Q. Do you think that physicians would want to know

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In Re: Bard IVC Filters Products Liability

1 the animal model testing related to the Bard filters?

2 A. Well, if --

3 MR. JOHNSON: Form.

4 THE WITNESS: If it showed -- If there were

5 issues that occurred with that, you know, I would think

6 physicians might be interested in that.

7 BY MR. BROWN:

8 Q. But you're not offering that opinion in this

9 case, are you?

10 A. You know, see, it's hard for me because I have

11 looked at the data in the Kessler study, and I just -- I'm

12 amazed what they decided to do for parameters to assess

13 this filter. I mean, they -- they basically had flawed

14 studies to get through an FDA safety and equivalency for

15 Simon Nitinol, which I think were -- maybe some of the

16 fault is FDA, but I think -- I think if I was aware of

17 those as, you know, in my role with Bard kind of trying to

18 introduce patients -- not patients, but physicians to put

19 this filter in, I think if I had known about that, I would

20 have said, "I'm not really so sure I'm comfortable about

21 this." Especially in light of the way things have turned

22 out where they have shown statistically high rates of --

23 of migration, perforation, fractures. So I don't know. I

24 might be off the track a little bit, Matthew, but am I --

25 am I getting my message across?

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 Q. Is it your opinion in this case that medical

2 device companies should provide all complaint files for

3 the medical devices to physicians?

4 MR. JOHNSON: Form.

5 THE WITNESS: You know, I would say as a general

6 statement, no. But when you -- when you start getting to

7 see signals, I think that's of concern because it's

8 transparency, and it's our ability to really do an

9 adequate informed consent. You know, that's -- or even

10 device selection for us. So I was -- You know, I thought

11 I was in a unique position with Bard; that, you know, I

12 was kind of a consultant with them. I helped them do

13 animal studies to get approval of what I thought were

14 better devices. They never showed me the data of any of

15 the animal studies I did. And then furthermore, they

16 never showed me any of this data that maybe would have

17 been -- I might have had opinions about that might have

18 been helpful for them. And you go why is that? Why --

19 Why was my opinion not important? And maybe if I had the

20 chance to look at that data I would have said, "I'm not so

21 sure about this test. You know, maybe we need to do

22 more."

23 You may get to this later, but, you know, they talked

24 to us in 2006 with this consensus agreement, and then

25 they -- they met with me a little bit after that asking

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 of the requisite preclinical and clinical safety and

2 effectiveness/risk benefit evidence that is mandatory to

3 justify widespread marketing of IVC filters for both

4 temporary and permanent placements."

5 Do you see that?

6 A. Yes, I do.

7 Q. All right. What is the standard that you're

8 using to define physicians' reasonable expectations?

9 A. You know, I think this has to do with basically

10 really knowing the long-term performance characteristics

11 of the filters that were -- we're putting in and also --

12 and so that includes the effectiveness, say, clot-trapping

13 ability and includes what those risks are, such as what we

14 have mentioned. These fractures, embolizations, the

15 migrations. So that's -- I think physicians want to know.

16 They are expecting to know that.

17 Really to do proper trans- -- transparent consent and

18 actually for selection also, selection of devices, you

19 know, you want to do the best thing for your patient, so

20 you want to know which device is the safest and the most

21 effective and which has -- has a reasonable risk-benefit

22 ratio. So I think to have physicians try to decide this

23 without that data is kind of -- it's marketing basically,

24 or it's kind of like the filter is the best filter

25 since -- This is the only filter you'll ever need. You

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 are kind of like well, that's kind of nice, but that

2 doesn't really help me select, say, your filter versus

3 somebody else's filter.

4 Q. Is Paragraph B suggesting that physicians should

5 receive all preclinical safety and effectiveness

6 evidence --

7 A. No.

8 MR. JOHNSON: Form.

9 BY MR. BROWN:

10 Q. -- for IVC filters?

11 MR. JOHNSON: Go ahead.

12 THE WITNESS: It's -- It's the pertinent -- the

13 pertinent stuff which we have been talking about, you

14 know. But not -- I'm sure your world is an overwhelming

15 amount of information. Our world is no different than

16 your world. So -- But we want to know the things that

17 help us make decisions, clinical decisions, and those are

18 recurrent pulmonary embolism, yeah, we want to know about

19 that. We want to know about caval thrombosis. We want to

20 know about recurrent DVT. We want to know about

21 fractures, embolizations, migrations, difficulties putting

22 filters in. I think those are -- those are the things

23 that are important to us.

24 BY MR. BROWN:

25 Q. So information that the company has related to

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 system, and we don't know -- we don't know what type of

2 filter it is, I'll do a KUB or a CT scan to see if that's

3 a difficult undertaking for me.

4 But maybe that's a little different than this because

5 what we're talking about here, we're talking about a

6 series of different devices that has, you know, higher

7 than our normal rates of fractures, migrations,

8 embolizations, perforations. And so how do we -- how do

9 we figure those out? How do we guide our patients as to

10 what's the right thing to do and are they at risk? And so

11 that's -- that's what this is.

12 Q. What are you saying that Bard should have

13 provided as it relates to this paragraph?

14 A. Well, you know, this is -- First of all, we

15 should have been notified about, you know, their concerns

16 about these high rates of issues. And then if you're

17 convinced that these are issues that are going on, how do

18 you figure out what patients are at risk from some

19 potentially life-threatening complication?

20 Q. Would the answer be some type of imaging?

21 A. Imaging is one, one thing. I mean, we do a

22 clinical evaluation, and imaging helps us. I mean,

23 clinical is only so good. You can't really feel a filter,

24 so the imaging does help you.

25 Q. Paragraph 75 reads, "It is our opinion that Bard

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Thomas Kinney , M.D. June 17, 2017

In Re: Bard IVC Filters Products Liability

1 lacked important safety information when it began

2 marketing each of their IVC filters regarding the risk of

3 complications associated with their IVC filters and, once

4 on the market, failed to provide practicing physicians

5 with timely and updated information of these risks,

6 including, without limitation, adequate information

7 related to the character, severity and frequency the

8 Recovery, G2/G2X and Eclipse IVC filter's high

9 complication rate in relation to its competitors and its

10 own products, including the SNF filter. This lack of

11 information precluded physicians from evaluating the

12 risk-benefit analysis for their patients. If Bard had

13 disclosed the information discussed within this" --

14 "within this report, reasonable physicians would not have

15 used these devices."

16 A. Okay.

17 Q. Does this paragraph relate to what we were

18 discussing earlier concerning what you believe Bard should

19 have told physicians about -- physicians about

20 complication rates associated with the filters?

21 MR. JOHNSON: Form.

22 THE WITNESS: I would say, yeah, in a general

23 sense, I would say that's true.

24 BY MR. BROWN:

25 Q. Is there anything else that you think Bard

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Exhibit J-P

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 99 of 105
Deposition of:

Anne Roberts , M.D.

July 7, 2017

In the Matter of:

In Re: Bard IVC Filters Products

Liability

Veritext Legal Solutions

1075 Peachtree St. NE , Suite 3625

Atlanta, GA, 30309

800.808.4958 | calendar-atl@veritext.com | 770.343.9696

Case 2:15-md-02641-DGC Document 8375-5 Filed 10/23/17 Page 100 of 105
Anne Roberts , M.D. July 7, 2017

In Re: Bard IVC Filters Products Liability

Page 210

1 Dr. Anne Christine Roberts, M.D. This deposition

2 is being held at 4240 La Jolla Village Drive,

3 San Diego, California 92037.

4 Videographer is Scott Tanaka here on

5 behalf of Veritext Legal Solutions. Today's date

6 is July 7th, 2017. Back on the record. The time

7 is 4:02 p.m.

8 BY MR. BROWN:

9 Q Dr. Roberts, you all right?

10 A No. Fine.

11 Q I want to go through some of your report

12 with you. Okay?

13 A Okay.

14 Q So if you have it in front of you, we

15 can flip through it together.

16 A I do.

17 Q The first thing is I wanted to ask you

18 about paragraph 3 --

19 A Sorry. What page?

20 Q Page 6.

21 A Paragraph 3. Okay.

22 Q It says, We have been asked to provide

23 our expert analyses and opinions on the following.

24 Then "A" says, four lines down, Considering

25 patient safety is the primary concern and that

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1 open, honest, and complete performance, safety and

2 complaint data from manufacturers are required for

3 physicians to fulfill their standard of care

4 responsibility to provide informed consent to

5 their patients.

6 Do you see that?

7 A I do.

8 Q Have you ever had an IVC filter

9 manufacturer provide you with the complete

10 performance, safety and complaint data regarding

11 their IVC filters?

12 A This is probably the thing that makes me

13 the craziest about this suit at all is the fact

14 that Bard knew that there was a problem and

15 even -- now granted, did I know? No. Because

16 nobody told us. It wasn't out there. It was

17 something that was known by Bard internally. They

18 had been looking at this. They knew there was a

19 problem.

20 And if you go back to even their health

21 analysis, hazard analysis even -- as you know, in

22 December of 2004 they basically -- they basically

23 talk about the fact that there's a problem with

24 this device. And, you know -- and that, you know,

25 they see in the MAUDE database that the reporting

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1 rates were 4.6, 4.4, 4.1, and 5.3 times higher

2 than reporting rates of all other filters.

3 This is the health hazard analysis by

4 David Ciavarella. Anyway, you know, and he looked

5 at this -- and this is in December -- December of

6 2004. And nobody came back and said, Wow, we're

7 really having a problem. Now, I don't -- you

8 know -- I mean, I think that physicians should

9 have known about this at that time.

10 So that basically -- but even more

11 importantly, Bard should have stopped selling

12 these things and said look, you know, we've got a

13 problem here. We need to figure out what it is

14 that's going on with this filter. And

15 nobody -- nobody does that. And it's basically

16 hidden. Nobody tells anything.

17 So it's not until these other memos come

18 out where somebody else does their own, you know,

19 hazard analysis and says, you know, we got a

20 problem here that all of a sudden the community

21 starts to understand that there is a problem here.

22 So it's not -- you know, I mean -- this is the

23 thing that really, really bothers me about this

24 whole thing is the fact that -- I mean, I look at

25 this as a physician. I'm taking care of patients.

Page 213

1 I'm responsibile for telling patients if I'm going

2 to put in a filter that at least I know what it is

3 that's going on.

4 And, in fact -- in fact, I can't give a

5 patient true consent because I -- I didn't have

6 the faintest idea that this is what was happening

7 with this filter. And Bard was not at all

8 transparent about this. And they should have

9 been. They should have come -- they should have

10 either stopped selling it and said, look, you

11 know, we're going to -- you know, we've had some

12 problems with this. We're going to, you know,

13 redesign it. We're going to redo our bench top

14 testing. We're going to show that -- you know,

15 we're going to make sure it's okay. Then we'll

16 see about rereleasing it.

17 But they didn't do that. And I think

18 that that's the thing that's so bothersome about

19 this case is basically, you know, people covered

20 it up. People hid it. They didn't allow the

21 physicians to know about it. They didn't -- there

22 was no way to consent the patients appropriately.

23 And, quite frankly, I think at least at this point

24 in time people -- because they assumed that it

25 was -- it was a filter that, yeah, it was supposed

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In Re: Bard IVC Filters Products Liability

Page 214

1 to be retrievable but it also had a permanent

2 indication that it could stay in permanently and

3 wouldn't cause problems.

4 And I think the -- this is where -- this

5 is where it all falls apart. This exactly --

6 patient safety. You know, any manufacturer should

7 put patients' safety as the most important thing

8 in selling something. You can't in good faith

9 sell something that isn't safe. It's supposed to

10 be -- you know, it's one of the things Kessler

11 says in his report. It's supposed to be as safe

12 and effective as the predicate device. And if the

13 manufacturer realizes it's not as safe, they

14 should not be selling it. Okay? So yeah. That's

15 my problem with this.

16 Q So in your opinion the information

17 that's contained in that health hazard evaluation

18 by David Ciavarella in December of 2004 should

19 have been provided to physicians?

20 MR. JOHNSON: Form objection.

21 BY MR. BROWN:

22 Q Is that what you're saying?

23 MR. LOPEZ: Only that after five

24 minutes?

25 MR. BROWN: That's not what I'm asking.

Page 215

1 BY MR. BROWN:

2 Q I'm asking you if it's your opinion that

3 the information that's contained in that health

4 hazard information from December of 2004 should

5 have been provided to physicians.

6 MR. JOHNSON: Form.

7 THE WITNESS: I think, first of all,

8 yes, it should have been provided to physicians

9 that we have a problem. Okay? Mission control,

10 we got a problem. Let's -- and then I think on

11 top of that Bard should have said we have a

12 problem. We are putting patients at risk. This

13 is not the predicator device. This is not other

14 filters that we've seen before. And we need to

15 stop this, and we need to look at the data. We

16 need to see what it is that's causing this

17 problem.

18 And that's -- yes, I think they should

19 have told physicians. And I think -- I'm not

20 saying you take this memo and you give them a

21 memo. But you tell them we have a problem. And,

22 more importantly, you stop putting it out there

23 until you figure out what the problem is. Okay?

24 I'll give you an example. When Meditech

25 put out the redesign -- put out the titanium

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1 filter, they put it out -- they had done some

2 testing on it. Looked like everything was okay.

3 They put it out in a relatively small release.

4 They put -- I mean, for example, we put them in --

5 we were big Greenfield user. They wanted us to

6 put them in -- they knew we knew how to do it,

7 blah-blah-blah.

8 So we start putting them in. We start

9 seeing that these things migrate. So, yes,

10 filters -- the legs can perforate and can -- they

11 didn't migrate the filter itself. It slid down a

12 little bit because the leg perforated. But we

13 called them and said we've got a problem. There's

14 a problem with this patient. They stopped -- they

15 stopped it. They stopped selling them. They

16 stopped sending them out. They called back the

17 ones that they had and said we got to figure out

18 what the problem is. And they redesigned it, and

19 then they put in another one.

20 That's what Bard should have done. Bard

21 should have said -- they got these memos. They

22 should have looked at this and went to the QA

23 person and said we've got a problem here. Nothing

24 happened. Just let's go ahead keep selling them,

25 keep selling them, keep selling them, you know,

Page 217

1 until tens of thousands of these things were sold

2 and put into people, at least, presumably, most of

3 them.

4 You know, maybe some that got expired

5 didn't get put in, whatever. But a lot of them

6 got sold. And this is -- you know, this is -- for

7 me this is the major concern that I have.

8 When I started seeing this stuff, this

9 is when I said I'm willing to testify because this

10 to me goes to the heart of the issue which is I

11 don't care if it's a manufacturer, you know, what

12 it is. You got to be honest. You got to tell

13 people. You can't cover it up. You got to tell

14 your physicians. The physicians have to know so

15 they can make a decision. Do we still put this

16 thing in? If they don't know that this is a

17 problem that Bard knows about and they don't

18 disclose it to the physician, what's the physician

19 supposed to know?

20 They're waiting to hear, you know, memos

21 from Temple or waiting to hear, you know,

22 something to get published. And in the meantime

23 it's just getting put in patients. And that's the

24 scary thing about this.

25 ///

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Page 234

1 BY MR. BROWN:

2 Q Do you know?

3 MR. JOHNSON: Form.

4 BY MR. BROWN:

5 Q Do you know what the regulations are?

6 MR. LOPEZ: Different question. Hold

7 on. He asked you two questions.

8 MR. BROWN: No, I didn't.

9 MR. LOPEZ: Yeah, you did. You said

10 regulations.

11 MR. BROWN: That's what I said in my

12 first question. I said do you have any knowledge

13 about the regulations that govern the kind of

14 information the medical device companies are

15 permitted to share with physicians?

16 BY MR. BROWN:

17 Q Do you have any knowledge of the

18 regulations?

19 A A device company can share --

20 Q That's not my question.

21 A I'm just saying --

22 Q I'm asking you a question. Please

23 answer my question.

24 Do you have any knowledge of the

25 regulations about the type of information that a

Page 235

1 medical device company is permitted to share with

2 physicians?

3 MR. JOHNSON: Form objection.

4 Explain yourself if you have to.

5 THE WITNESS: I don't believe that there

6 are regulations that prohibit device companies

7 from sharing information. Now, that is not

8 necessarily true with other regulatory agencies

9 such as FDA which cannot share information --

10 proprietary information to the public or anybody

11 else with -- you know, without the consent or not

12 even with the consent of the company. The company

13 should be under no restraint from sharing

14 information if they deem it reasonable.

15 BY MR. BROWN:

16 Q Has any medical device company provided

17 you with its testing and monitoring data for their

18 patients?

19 MR. JOHNSON: Form.

20 THE WITNESS: Well, number -- I mean, in

21 terms of -- for example, in instructions for use

22 there can be information about patients and

23 patient outcomes and specific information about

24 patients. So to that extent, yes, I think

25 companies do share that information partially

Page 236

1 probably because they're required to by the

2 instructions for use. They will -- if there is a

3 clinical trial, they -- that clinical trial data

4 will be published. So that, I assume, is

5 considered sharing of company information.

6 BY MR. BROWN:

7 Q In any other context has a medical

8 device company provided you with its testing and

9 monitoring data for their products?

10 A I don't know that I've actually asked

11 them.

12 Q So, no, they have not?

13 A Outside of the context of clinical

14 trials -- in a clinical trial, yeah, you get all

15 of that data.

16 Q Anything else?

17 A Anything else?

18 Q Are there any other instances in which a

19 medical device company has shared with you its

20 testing and monitoring data other than in the IFU

21 or the clinical trial data?

22 MR. JOHNSON: Form.

23 THE WITNESS: I don't believe so. I

24 don't know that I've asked for it. And I don't

25 know that anyone has come to me and said, here;

Page 237

1 this is our data.

2 BY MR. BROWN:

3 Q There are opinions that you've given in

4 paragraphs 3, 4, 6, and 7. And take a minute to

5 refresh your memory about what those opinions are.

6 A Okay.

7 Q Let me know what you have --

8 A Was it the one we've kind of gone

9 through that has multiple subsections? Is that

10 correct?

11 Q That's right.

12 A So we have covered those now?

13 Q So three, four, six, and seven.

14 A Four, four. Oh, not five. Okay.

15 Q All of those paragraphs concern your

16 opinions about the type of information that Bard

17 should be providing to physicians and to patients,

18 correct?

19 A Yes.

20 Q Do you have any written standard or

21 authority that you're relying on to make any of

22 the opinions that are in those paragraphs?

23 MR. LOPEZ: Form.

24 THE WITNESS: I don't have any written

25 standards for that. I think that this is

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Page 238

1 something that physicians expect from companies.

2 Now -- and, again, I don't think in here that we

3 mean that you give us all of your databank. I

4 don't think it means that we expect that you're

5 going to tell us everything about a device. I

6 think what it means is that if a company finds

7 that there is a problem and that problem is such

8 that it affects the safety and efficacy of a

9 device, then a company has an obligation either to

10 get that device off the market temporarily or

11 permanently or to make sure that physicians know

12 what it is that they're up against so that they

13 can make good informed consent for their

14 patients.

15 BY MR. BROWN:

16 Q All of the opinions that we just

17 discussed and the ones you reviewed in paragraphs

18 3, 4, 6, and 7 there's no way to test your

19 opinion, is there?

20 MR. JOHNSON: Form.

21 THE WITNESS: Only to ask a patient or a

22 family or the patient died and find out whether or

23 not they think it's reasonable to know that the

24 physician should have known about this so that

25 they could inform their patient appropriately.

Page 239

1 BY MR. BROWN:

2 Q Any other way that you know of to test

3 your opinions?

4 A Ask you whether you think it's

5 reasonable or not.

6 MR. LOPEZ: Or we'll just let a jury

7 decide maybe.

8 BY MR. BROWN:

9 Q If you got 100 doctors in the room,

10 there's no way to tell which ones would agree with

11 you and which ones would disagree with you?

12 MR. JOHNSON: Form.

13 MR. LOPEZ: About?

14 BY MR. BROWN:

15 Q About the opinions contained in

16 paragraphs 3, 4, 6, and 7.

17 A Would be an interesting exercise. Maybe

18 someone could do that study and show people this

19 data and say, Out of 100 people that are in this

20 room, how many people think that it would have

21 been reasonable that the company release this data

22 to the physicians who are implanting this device

23 and putting, essentially, their patients at risk?

24 Q The opinions --

25 A Maybe I'll do the study.

Page 240

1 Q The opinions that you set forth in

2 paragraphs 3, 4, 6, and 7, you've never published

3 anything on those opinions, have you?

4 MR. JOHNSON: Form.

5 THE WITNESS: That companies should give

6 safety and effectiveness data?

7 BY MR. BROWN:

8 Q The types of data that you are

9 discussing in those paragraphs.

10 A Well, we say that we need safety and

11 effectiveness data that the companies possess from

12 testing and monitoring their medical devices,

13 particularly implantable devices, to allow

14 physicians to provide full and fair balanced

15 informed consent to patients whom these devices

16 are prescribed and indicated. I have talked about

17 safety and effectiveness and how that is important

18 in device regulation and in, you know, device

19 design. So I guess I have talked about it.

20 I don't know that I talked about it in

21 the context of this particular device or

22 particular devices. But that, I think, is a very

23 common standard that physicians use in terms of

24 deciding whether or not to put a particular device

25 into a patient.

Page 241

1 And, remember, there is a choice. Okay?

2 There's a choice of the device to use. So if

3 somebody knows that there's a question about the

4 safetyness and effectiveness of a device, then at

5 least they can choose or they can help involve

6 their patient in the choice of what device to use.

7 And if they feel that this device has

8 characteristics that mitigate the potential for

9 harm, then they can make that choice. But without

10 that information, they have no way of making that

11 choice.

12 Q Throughout your report you cite to

13 Dr. Kessler's report, Dr. Ritchie's report, and

14 Dr. Betensky's report; is that right?

15 A Yes. Among others, yes.

16 Q Did you ever read the 2016 deposition of

17 Drs. Kessler and Betensky?

18 A As I said earlier, I don't believe that

19 I've read Kessler's deposition.

20 Q Have you read the previous deposition

21 transcript of Dr. Ritchie?

22 A I think I have. Remind me who Ritchie

23 is because it's been a while.

24 Q Ritchie testified numerous times over

25 the past several years.

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Page 294

1 bad outcome that the -- that litigation in terms

2 of -- in terms of how consent was obtained or

3 whatever is not -- is going to be a little

4 different from person to person potentially.

5 And so it's not something in terms of

6 what the clinical decision is with -- by the

7 practitioner.

8 BY MR. BROWN:

9 Q How does this document relate to your

10 opinions in this case?

11 A Well, I think it's -- I don't think it

12 has to do with the -- with litigation per se. I

13 think this has to do with what it is that one owes

14 a patient in terms of making sure that the patient

15 or representative or, when appropriate, the

16 patient's family has the opportunity to understand

17 the treatment or procedure the patient is to

18 receive and its reasonable risk benefits and

19 alternatives to have all questions answered and to

20 fully consent to the treatment or procedure.

21 So if you don't have information that's

22 available, you can't give the patient or the

23 representative or the patient's family an

24 opportunity to really understand the treatment or

25 procedure because you can't tell them what their

Page 295

1 reasonable risks and benefits and alternatives are

2 to that procedure.

3 So if you believe -- or if you were to

4 know that a device had a problem with it, then --

5 and you don't know that, you cannot give them the

6 reasonable risk and benefits of the procedure. So

7 that's where -- that's where the problem with the

8 -- you know, that we're outlining here is that the

9 informed consent requires -- requires that.

10 Q These practice parameters that we've

11 marked as Exhibit 15 to today's deposition deal

12 with providing certain information to patients,

13 correct?

14 A Yes -- this one specifically for

15 informed consent.

16 Q You're saying that in order for you to

17 provide informed consent, as discussed in these

18 practice parameters, you need certain information

19 from Bard, correct?

20 A Well, I need -- you know, it

21 doesn't -- it's any -- any manufacturer

22 that -- you're -- you're giving a consent based on

23 the data based on what is known about the product.

24 MR. LOPEZ: I think we're at seven

25 hours, by the way.

Page 296

1 MR. BROWN: We're not. We have nine

2 minutes.

3 THE VIDEOGRAPHER: We are 6 hours, 53

4 minutes of record.

5 BY MR. BROWN:

6 Q You don't have any written authority

7 that you're relying on to say that the type of

8 information that you're demanding from Bard is

9 needed to satisfy the informed consent standard of

10 care, do you?

11 MR. JOHNSON: Form objection.

12 THE WITNESS: I'm saying that a patient

13 that -- if a company knows that there's a problem

14 with their device or their drugs or whatever it

15 is, that they have a duty to make sure that a

16 practitioner is aware of that; if they're going to

17 continue to sell that device, that they need --

18 the physician needs to know so they can do an

19 adequate informed consent.

20 BY MR. BROWN:

21 Q That's the Dr. Roberts' standard,

22 correct?

23 MR. LOPEZ: Form.

24 THE WITNESS: Well, we'll have to get

25 100 people in a room and find out.

Page 297

1 BY MR. BROWN:

2 Q But as we sit here today, we haven't

3 gotten 100 people in the room to find out, have

4 we?

5 MR. JOHNSON: Form.

6 THE WITNESS: Well, I mean, at least in

7 here it would indicate that a physician -- that

8 the physician should -- that the physician is

9 supposed to give the best information to the

10 patient in terms of risk and benefits of the

11 procedure. And if you don't know, you give what

12 you know.

13 MR. BROWN: Thank you, Dr. Roberts. I

14 don't have any further questions for you at this

15 time.

16

17 EXAMINATION

18 BY MR. LOPEZ:

19 Q While we are on that document -- if you

20 just look at your report, Doctor -- it's easier

21 for me to do it that way. If you look at page 10

22 of your report, we're talking about the same

23 guidelines that Mr. Brown was talking to you

24 about.

25 Do you see that?

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