EXHIBIT 13

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 1 of 55
Ko32-92-6 

OCT 312003 

Submitted By: 

Contact: 

Date Prepared: 

Device: 

Trade Name: 

Common/Usual Name 

Proposed Classification: 

& Product Code 

510(k) SUMMARY 

Cook Incorporated 

Jennifer Bosley, MBA 

Regulatory Affairs Coordinator 

Tel: (812) 339 -2235 

Fax: (812) 332 -0281 

October 31, 2003 

Günther TulipTM Vena Cava Filter and Retrieval Set 

Inferior Vena Cava Filter and Retrieval Set 

Filter, Intravascular, Cardiovascular 

21 CFR §870.3375, Class II, DTK- Cardiovascular 

Intended Use: 

Filter Set: 

The Günther TulipTM Vena Cava Filter Set is indicated for the prevention of recurrent 

pulmonary embolism via placement in the vena cava in the following situations: 

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; 

Failure of anticoagulant therapy in thromboembolic diseases; 

Emergency treatment following massive pulmonary embolism where anticipated 

benefits of conventional therapy are reduced; and 

Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is 

contraindicated. 

The Günther TulipTM Vena Cava Filter may be retrieved according to the instructions 

supplied in the section labeled: Optional Retrieval Procedure. 

Retrieval Set: 

The Günther TulipTM Vena Cava Filter Retrieval Set has been designed for retrieval of an 

implanted Günther TulipTM Vena Cava Filter in patients who no longer require a filter. 

Retrieval of the filter can be performed only by jugular approach. 

Predicate Devices: 

The subject devices are substantially equivalent to predicate devices: Günther TulipTM 

Vena Cava MReye® Filter, #K000855 (Cook Incorporated); Amplatz Goose Neck Snare, 

#1972511 (Microvena Corp.); and the Radius Microsnare, #K022201 (Radius Medical 

Technologies). 

1 

EXHI : IT N ,__, 7 d %/!. 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 2 of 55
Device Description: 

The Günther TulipTm Vena Cava Filter and Retrieval Set is an inferior vena cava filter 

with a radiopaque band at the tip, which can be introduced via either femoral or jugular 

vein. The radiopaque retrieval catheter has a braided platinum loop at the distal end. 

Substantial Equivalence: 

The subject device is similar with respect to intended use, materials and functional 

characteristics of commercially available predicate devices in terms of section 510(k) 

substantial equivalence; any differences that may exist do not significantly affect the 

safety and effectiveness of the device. 

Test Data: 

The Günther TulipTM Vena Cava Filter and Retrieval Set have been subjected to and have 

passed the following tests to ensure reliable design and performance under the specified 

testing parameters: 

Filter Set: Retrieval Set: 

Biocompatibility Biocompatibility 

Material and stress analysis tests Tensile 

Clinical experience Clinical evaluation 

Clinical Experience: 

To evaluate the safety of retrieving the Günther Tulip Tm Vena Cava Filter, a clinical 

study was conducted in which 41 patients [female (n=19); male (n=22)] were enrolled for 

possible retrieval of the filter. Indications for placement of retrievable filter in the study 

included: bleeding while anticoagulated (n=2), recent bleeding not anticoagulated (n=0), 

prophylactic pre-op (n=12), prophylactic post-op (n=3), failure of anticoagulation 

resulting in recurrent PE (n=1), failure of anticoagulation resulting in extension of DVT 

(n=0), prophylaxis following PE (n=3), prophylaxis with extensive DVT (n=3), trauma 

(n=13) and other (n=4). 

Retrieval was not attempted in 15 patients due to the continued need for permanent 

implantation of the filter. A total of 26 attempted retrievals in 26 patients were 

successful. [n= number of filters retrieved] Retrieval of filter immediately after 

deployment at Day 0 (n=1), Day 2 (n=1), Day 7 (n=1), Day 9,(n=3), Day 10 (n=6), Day 

11(n=2), Day 12 (n=1), Day 13 (n=4), Day 14 (n=6), Day 20 (n=1). No adverse events 

were reported in the retrieved filter group. 23 patients in whom a filter was retrieved 

were followed for three months post retrieval with no abnounalities reported. Results 

from the clinical study showed that the filter could be safely retrieved up to 14 days or 

longer in patients who no longer required an inferior vena cava filter. Time to retrieval 

ranged from 2-20 days with a mean implantation time of 11.4 days. 

2 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 3 of 55
DEPARTMENT OF HEALTH &t HUMAN SERVICES Public Health Service 

OCT 312003 

Cook Incorporated 

c/o Ms. Jennifer J. Bosley 

Regulatory Affairs Coordinator 

P.O. Box 489 

Bloomington, IN 47402 -0489 

Re: K032426 

Günther TulipTM Vena Cava MReye® Filter and Retrieval Set 

Regulation Number: 21 CFR 870.3375 

Regulation Name: Cardiovascular intravascular filter 

Regulatory Class: Class II 

Product Code: DTK 

Dated: August 5, 2003 

Received: August 6, 2003 

Dear Ms. Bosley: 

Food and Drug Administration 

9200 Corporate Boulevard 

Rockville MD 20850 

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined the device is,substantially equivalent (for the indications 

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 

You may, therefore, market the device, subject to the general controls provisions of the Act. The 

general controls provisions of the Act include requirements for annual registration, listing of 

devices, good manufacturing practice, labeling, and prohibitions against misbranding and 

adulteration. 

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 

may be subject to such additional controls. Existing major regulations affecting your device can 

be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 

publish further announcements concerning your device in the Federal Register. 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 4 of 55
Page 2 - Ms. Jennifer J. Bosley 

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 

that FDA has made a determination that your device complies with other requirements of the Act 

or any Federal statutes and regulations administered by other Federal agencies. You must 

comply with all the Act's requirements, including, but not limited to: registration and listing (21 

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 

product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000 -1050. 

This letter will allow you to begin marketing your device as described in your Section 510(k) 

premarket notification. The FDA finding of substantial equivalence of your device to a legally 

marketed predicate device results in a classification for your device and thus, permits your device 

to proceed to the market. 

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 

contact the Office of Compliance at (301) 594 -4646. Also, please note the regulation entitled, 

"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 

other general information on your responsibilities under the Act from the Division of Small 

Manufacturers, International and Consumer Assistance at its toll -free number (800) 638 -2041 or 

(301) 443 -6597 or at its Internet address http:// www. fda.gov /cdrh/dsma/dsmamain.html 

Sincerely yours, 

Enclosure 

Bram D. erman, M.D. 

Director 

Division of Cardiovascular Devices 

Office of Device Evaluation 

Center, for Devices and 

Radiological Health 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 5 of 55
Indications for Use Statement 

510(k) Number (if known): K032426 

Device Name: Günther Tulipim Vena Cava Filter and Retrieval Set 

Filter Set 

The Giinther TulipTm Vena Cava Filter Set is indicated for the prevention of recurrent 

pulmonary embolism via placement in the vena cava in the following situations: 

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; 

Failure of anticoagulant therapy in thromboembolic diseases; 

Emergency treatment following massive pulmonary embolism where anticipated benefits of 

conventional therapy are reduced; and 

Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is 

contraindicated. 

The Günther TulipTm Vena Cava Filter may be retrieved according to the instructions supplied 

in the section labeled: Optional Retrieval Procedure. 

Retrieval Set 

The Günther TulipTm Vena Cava Filter Retrieval Set has been designed for retrieval of an 

implanted Günther Tulip Tm Vena Cava Filter in patients who no longer require a filter. 

Retrieval of the filter can be performed only by jugular approach. 

PI EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF 

NEEDED 

Concurrence of CDRH, Office of Device Evaluation (ODE) 

Prescription Use 7 

(Per 21 CFR 801.109) 

OR Over-The-Counter Use 

(Optional Format 1-2-96) 

(Division S' 

Division o °vascular Devices! 

510(k) Number 03 7-4 24 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 6 of 55
EXHIBIT 14

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 7 of 55
Submitter: 

Date 

Prepared: 

General 

Provisions: 

Predicate 

Devices: 

MAR 2 2 ?.004 

k05110 50 

510(k) 

Summary of Safety and Effectiveness 

Donna Marshall 

Regulatory Affairs Associate II 

Cordis Corporation 

7 Powderhorn Drive 

Warren, NJ 07059 

Telephone: 

Fax 

e -mail address 

December 29, 2003 

Trade Name: 

Common Name: 

Classification Name: 

Device -classification: 

908-412-3844 

908-412-3915 

dmarshal(a,crdus. ¡nj.com 

Cordis OptEaseTM Vena Cava Filter 

Vena Cava Filter and Introduction Kit 

Cardiovascular Intravascular Filter (per 21 CFR 

870.3375) 

Class II 

The subject Cordis OptEase Vena Cava Filter is substantially equivalent to: 

Cordis OptEase Permanent Vena Cava Filter and Introduction Kit 

( #K023116) 

Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit 

( #K000062 and #K020316) 

Recovery Filter System, Bard Peripheral Vascular, C.R. Bard, Inc. 

(#K031328) 

Günther TulipTM Vena Cava Filter and Retrieval set, Cook Incorporated 

( #K032426) 

Cordis VISTA BRITE TIP® Guiding Catheter ( #K965211) 

B-001 1 77 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 8 of 55
Performance 

Standards 

Indications 

for Use for 

Filter: 

Indications for 

Use for 

Retrieval 

Catheter: 

Device 

Description 

As per 21 CFR 870.3375, the following special controls were established for 

cardiovascular intravascular filters: 

Use of International Standards Organization's ISO-10993 'Biological 

Evaluation of Medical Devices Part 1: Evaluation and Testing, 

FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final 

Guidance for Industry and FDA, August 30, 2002, and 

FDA's Guidance for Cardiovascular Intravascular Filter 510(k) 

Submissions, dated November 26, 1999. 

The Cordis OptEase Vena Cava Filter is indicated for the prevention of 

recurrent pulmonary embolism via percutaneous placement in the inferior 

vena cava in the following situations: 

Pulmonary thromboembolism when anticoagulants are contraindicated, 

Failure of anticoagulant therapy in thromboembolic diseases, 

Emergency treatment following massive pulmonary embolism where 

anticipated, 

Chronic, recurrent pulmonary embolism where anticoagulant therapy has 

failed or is contraindicated. 

The OptEase Filter may be removed according to the instructions supplied in 

the Section labeled: Optional Procedure for Filter Retrieval. 

The Angiographic Vessel Dilator is designed to provide angiographie 

visualization and linear measurement of the vasculature when combined with 

the delivery of radiopaque contrast media to the Vena Cava. 

The Cordis OptEase Retrieval Catheter is indicated for the retrieval of the 

Cordis OptEase Vena Cava Filter from the inferior vena cava. Retrieval of the 

OptEase Filter is possible only from the femoral vein approach. 

The subject OptEase Filter is identical to the predicate OptEase Permanent 

Vena Cava Filter with the exception of the addition of the retrievability option 

to the labeling. The OptEase Vena Cava Filter is packaged with a filter 

introduction kit that includes the Angiographie Vessel Dilator, a directional 

filter storage tube, catheter sheath introducer and obturator for safe and 

accurate deployment of the filter. 

The subject OptEase Filter is substantially equivalent to the predicate devices 

(i.e., OptEase Permanent Vena Cava Filter, TrapEase Permanent Vena Cava 

Filter, Recovery Filter System, and Günther Tulip Tm Vena Cava Filter and 

Retrieval Set). 

B-002 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 9 of 55
Device The subject Opt Ease Retrieval Catheter is an 80 cm long, 10F catheter with 

Description radiopaque tip. The subject device is packaged separately and is intended for 

(continued) the percutaneous retrieval of the OptEase Filter from the inferior vena cava 

when used with an appropriate Endovascular snare. The subject device is 

substantially equivalent to the predicates devices (i.e., the Günther Tulip 

Vena Cava Filter and Retrieval Set and the VISTA BRITE TIPL Guiding 

Catheter). 

Performance The safety and effectiveness of the Cordis OptEase Vena Cava Filter and the 

Data: OptEase Retrieval Catheter have been demonstrated via data collected from 

in-vitro, animal and clinical testing and analyses. The safety of retrieval of 

the OptEase Filter was evaluated in a prospective clinical study (n = 21 

retrieval patients) and in a retrospective clinical experience (n = 40 retrieval 

patients). In the prospective clinical study, the time to retrieval ranged from 

5 - 14 days (mean implantation time of 11.1 ± 1.8 days). In the retrospective 

clinical experience, the time to retrieval ranged from 3 - 48 days in 29 

patients (mean implantation time of 16.4 ± 7.2 days). Eleven patients in the 

. retrospective clinical experience had their filter captured from the vessel wall 

and then redeployed at the different location within the inferior vena cava 

(capture time ranged from 4 - 30 days, mean of 13.8 ± 6.1 days). The 

OptEase Filter was subsequently retrieved from this subset of patients. 

Summary of The design, material, components, and fundamental technology featured with 

Substantial the Cordis OptEase Vena Cava are substantially equivalent to those featured 

Equivalence with the predecessor Cordis OptEase Permanent Vena Cava Filter and 

Introduction Kit and the Cordis TrapEase Permanent Vena Cava Filter and 

Introduction Kit. In addition, the intended use for the OptEase Vena Cava 

Filter is substantially equivalent with the Recovery Filter System and the 

Günther Tulip Vena Cava Filter and Retrieval Set. 

The design and materials of the OptEase Retrieval Catheter are substantially 

equivalent to the VISTA BRITE TIP Guiding Catheter. The intended use for 

OptEase Retrieval Catheter is substantially equivalent to the Günther Tulip 

Vena Cava Filter and Retrieval Set. 

B-003 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 10 of 55
DEPARTMENT 014 HEALTH & HUMAN SERVICES Public Health Service 

Z Z 2004 

Cordis Corporation 

c/o Ms. Donna Marshall 

Regulatory Affairs Associate II 

7 Powder Horn Drive 

Warren, NJ 07059 

Food and Drug Administration 

9200 Corporate Boulevard 

Rockville MD 201350 

Re: K034050 

Trade Name: Cordis OptEaseTM Vena Cava Filter and Optease TM Retrievable Catheter 

Regulation Number: 21 CFR 870.3375 

Regulation Name: Cardiovascular Intravascular Filter 

Regulatory Class: II (two) 

Product Code: DTK 

Dated: December 29, 2003 

Received: December 30, 2003 

Dear Ms. Marshall: 

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined the device is substantially equivalent (for the indications 

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 

You may, therefore, market the device, subject to the general controls provisions of the Act. The 

general controls provisions of the Act include requirements for annual registration, listing of 

devices, good manufacturing practice, labeling, and prohibitions against misbranding and 

adulteration. 

If your device is classified (see above) into either class JI (Special Controls) or class Ill (PMA), it 

may be subject to such additional controls. Existing major regulations affecting your device can 

be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 

-publish further announcements concerning your device in the Federal Register. 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 11 of 55
Page 2 - Ms. Donna Marshall 

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 

that FDA has made a determination that your device complies with other requirements of the Act 

or any Federal statutes and regulations administered by other Federal agencies. You must 

comply with all the Act's requirements, including, but not limited to: registration and listing (21 

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 

This letter will allow you to begin marketing your device as described in your Section 510(k) 

premarket notification. The FDA finding of substantial equivalence of your device to a legally 

marketed predicate device results in a classification for your device and thus, permits your device 

to proceed to the market. 

If you desire specific advice for your device on OUT labeling regulation (21 CFR Part 801), please 

contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, 

"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 

other general information on your responsibilities under the Act from the Division of Small 

Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 

(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaidsmamain.html 

Sincerely yours, 

Dwukk 

Bram D. Zuckerman, M.D. 

Director 

Division of Cardiovascular Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

Enclosure 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 12 of 55
Indications for Use 

510(k) Number (if known): K034050 

Device Name: Cordis Opt Ease Vena Cava Filter and OptEaseTm Retrieval Catheter 

Indications For Use: 

The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) 

via percutaneous placement in the vena cava in the following situations: 

Pulmonary thromboembolism when anticoagulants are contraindicated, 

Failure of anticoagulant therapy for thromboembolic disease, 

Emergency treatment following massive pulmonary embolism where anticipated, 

Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is 

contraindicated 

The OPTEASE Filter may be retrieved according to the instructions supplied in the Section 

labeled: Optional Procedure for Filter Retrieval. 

The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear 

measurement of the vasculature when combined with the delivery of radiopaque contrast 

media to the vena cava. 

Prescription Use X AND/OR Over-The-Counter Use 

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) 

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF 

NEEDED) 

Concurrence of CDRH, Office of Device Evaluation (ODE) 

(Division Sig. 

Division of Cardiovascular vlo-z 

MOO Number Page 1 of _1 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 13 of 55
EXHIBIT 15

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

(FILED UNDER SEAL)

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 14 of 55
EXHIBIT 16

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 15 of 55
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Robert W. Boatman (009619) - rwb(a,gknet.com 

Paul L. Stoller (016773) - aul.stoller gknet.com 

Shannon L. Clark (019708) - SLC @gknet.com 

GALLAGHER & KENNEDY, P.A. 

2575 East Camelback Road 

Phoenix, Arizona 85016 -9225 

Telephone: (602) 530 -8000 

Ramon Rossi Lopez (CA Bar No. 86361) 

(admitted pro hac vice) 

LOPEZ McHUGH LLP 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

rlopez @lopezmchugh.com 

Co- Lead/Liaison Counsel for Plaintiffs 

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: BARD IVC FILTERS 

PRODUCTS LIABILITY LITIGATION 

MD No. 02641 

PLAINTIFFS' NOTICE OF 

DEPOSITION PURSUANT TO 

FEDERAL RULE 

(O(F}CIVIL 

RELATED REQUESTS FOR 

PRODUCTION OF DOCUMENTS 

YOU ARE HEREBY NOTIFIED that, in accordance with Rule 30(b)(6), Fed. R. 

Civ. P., Plaintiff will depose the representative of C R Bard Incorporated and Bard 

Peripheral Vascular Incorporated ( "BARD ") who is the most knowledgeable regarding the 

following matters set forth in Exhibit A. 

DATE/TIME OF DEPOSITION: December 15, 2015, 10 a.m. 

LOCATION OF DEPOSITION: Gallagher & Kennedy, P.A. 

2575 East Camelback Road, Suite 1100 

Phoenix, Arizona 85016 

The deposition will be taken upon oral examination before a stenographic court 

reporter or some other officer duly authorized by law to take oaths and acknowledgements 

in the State of Arizona. The deposition will continue day to day until completed and will 

be videotaped. This deposition is being taken for the purpose of discovery, for use at trial 

or both of the foregoing, or for such other purposes as permitted under the applicable rules 

and governing law. 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 16 of 55
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PLEASE TAKE FURTHER NOTICE that, pursuant to Rule 34, Fed. R. Civ. P., 

BARD is to produce by November 10, 2015 the documents and tangible things identified 

in Exhibit B attached hereto. 

DATED this 5th day of November 2015. 

GALL GHER & 

By: 14/7 

Robert W. Boatman 

Paul L. Stoller 

Shannon L. Clark 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

KENNEDY, P.A. 

LOPEZ McHUGH LLP 

Ramon Rossi Lopez (CA Bar No. 86361) 

(admittedpro hac vice) 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

Co-Lead/Liaison Counsel for Plaintiffs 

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CERTIFICATE OF SERVICE 

I hereby certify that on November 541 2015 a true and correct copy of the 

foregoing was sent via U.S. Mail and/or Electronic Mail to: 

James R. Condo 

Snell & Wilmer LLP 

One Arizona Center 

400 East Van Buren Street 

Suite 1900 

Phoenix, Arizona 85004 

Attorneys for Defendants 

Richard B. North, Jr. 

Nelson Mullins Riley & Scarborough LLP 

.,_Atlantic Station 

201 17' Street NW, Suite 1700 

Atlanta, Georgia 30363 

Attorneys for Defendants 

*Counsel for Plaintiffs will be served in accordance 

with the Court's Case Management Order No. 1 

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EXHIBIT A, 

Definitions. 

The following definitions apply to this Notice of Deposition, including those 

matters set forth in Exhibit A hereto, and are deemed to be incorporated into each subject 

and request for documents listed below: 

1. "Identify" or "identity" with respect to persons, means to give, to the extent 

known, the person's full name, present or last known address, and when referring to a 

natural person, additionally, the present or last known place of employment. 

2. BARD means defendants C.R. BARD INC. and BARD PERIPHERAL 

VASCULAR. INC., and any of its subsidiaries, affiliates, officers, agents, attorneys, 

employees, representatives, or others acting on its behalf. 

3. "Person" means natural person, as well as corporate and/or governmental 

entity. 

4. "WC Filter" means all IVC Filters manufactured or distributed by BARD 

or its predecessors prior to assignment or sale of such filters to BARD. Also included is 

any device intended to retrieve any filter or to introduce any filter into the body. 

5. "Relating to," "relate to," "referring to," "refer to," "reflecting," "reflect," 

"with regard to," "concerning," or "concern" shall mean evidencing, regarding, 

concerning, discussing, embodying, describing, summarizing, containing, constituting, 

showing, mentioning, reflecting, pertaining to, dealing with, relating to, referring to in any 

way or manner, or in any way logically or factually, connecting with the matter described 

in that paragraph of these demands, including documents attached to or used in the 

preparation of or concerning the preparation of the documents. 

6. "Documents" as used in this Request is coextensive with the meaning of the 

terms "documents" and "tangible things" in FRCP 34, and shall have the broadest 

possible meaning and interpretation ascribed to the terms "documents" and "tangible 

things" under FRCP 34. Consistent with the above definition, the term document shall 

include, without limitation, any written, printed, typed, photostatic, photographed, 

4 

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recorded, computer-generated, computer- stored, or otherwise maintained or reproduced 

communication or representation, any data compilation in any form, whether comprised of 

letters, words, numbers, pictures, sounds, bytes, e-mails, electronic signals or impulses, 

electronic data, active files, deleted files, file fragments, or any combination thereof 

including, without limitation, all memoranda, notes, records, letters, envelopes, telegrams, 

messages, studies, analyses, contracts, agreements, projections, estimates, working papers, 

accounts, analytical records, reports and/or summaries of investigations, opinions or 

reports of consultants, opinions or reports of experts, opinions or reports of accountants, 

other reports, trade letters, press releases, comparisons, books, diaries, articles, magazines, 

newspapers, booklets, brochures, pamphlets, circulars, bulletins, notices, forecasts, 

drawings, diagrams, instructions, minutes of meetings or communications of any type, 

including inter- and intra-office communications, questionnaires, surveys, charts, graphs, 

photographs, phonographs, films, tapes, discs, data cells, drums, printouts, all other 

compiled data which can be obtained (translated, if necessary, through intermediary or 

other devices into usable forms), documents maintained on, stored in or generated on any 

electronic transfer or storage system, any preliminary versions, drafts or revisions of any 

of the foregoing, and other writings or documents of whatever description or kind, whether 

produced or authorized by or on behalf of you or anyone else, and shall include all nonidentical copies and drafts of any of the foregoing now in the possession, custody or 

control of you, or the former or present directors, officers, counsel, agents, employees, 

partners, consultants, principals, and/or persons acting on your behalf. 

7. "Or" and "and" will be used interchangeably. 

peposition Subject Matter 

Pursuant to Rule 30(b)(6), BARD shall designate and produce for deposition one or 

more of its officers, directors, managing agents, or other persons who consent to testify on 

its behalf concerning the following subject matters: 

/ / / 

/ / / 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 20 of 55
2 

3 

4 

5 

6 

7 

8 

9 

10 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

FDA WARNING LETTER DA I ED JULY 13. 2015: 

1. All communications with FDA officials regarding the subject matter and 

content of the warning letter issued by FDA on July 13, 2015 including but not limited to 

communications described in the letter. 

2. The identity of BARD's corporate officers and other employees (including 

but not limited to their titles, duties and dates of such responsibility) who were and are 

responsible for communicating with regulatory officials with the FDA and related 

regulatory bodies concerning the subject matter and content of the warning letter issued 

by FDA on July 13, 2015. 

3. The visits/inspections from/by the FDA to Bard facilities on the dates listed 

in the warning letter issued by the FDA on July 13, 2015. 

4. The failure to establish and maintain procedures for receiving, reviewing 

and evaluating complaints associated with Bard's IVC filters and Bard IVC filter removal 

products as described in the warning letter issued by the FDA on July 13, 2015. 

5. Determination of lot numbers subject to the failure to establish and maintain 

procedures for acceptance of incoming product as described in paragraph 5 of the warning 

letter issued by the FDA on July 13, 2015. 

6. The failure to submit reports as described in paragraph 7 of the warning 

letter issued by the FDA on July 13, 2015 and the responses submitted by Bard to the 

FDA listed as inadequate. 

7. Actions taken by defendants since the issuance of the warning letter issued 

by FDA on July 13, 2015. 

6 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 21 of 55
E2W, 1M1,I1 

2 DOCUMENTS TO BE PRODUCED 

3 1. An unredacted and final copy of the warning letter issued by FDA on 

4 July 13, 2015 to Bard. 

5 2. All communications with FDA related to the subject matter of the warning 

6 letter issued by the FDA on July 13, 2015. 

7 3. All documents which reflect a regulatory log of contacts with the FDA 

8 regarding the warning letter issued by FDA on July 13, 2015. 

9 4. All complaint files referenced in the warning letter issued by FDA on 

10 July 13, 2015. 

11 5. All complaint files provided to and/or reviewed by FDA as part of the 

12 investigation and inspections that resulted in the warning letter issued by FDA on July 13, 

13 2015. 

14 6. All documents and material provided to FDA during the course of its 

15 inspection and investigation that resulted in the warning letter issued by FDA on July 13, 

16 2015. 

17 7. All internal communications relating to the subject matter of the warning 

18 letterissuedbyFDAonJuly 13, 2015. 

19 8. Communications with FDA and internally at BARD since the issuance of 

20 the warning letter issued by FDA on July 13, 2015 which pertain to the subject matter and 

2 1 content of said warning letter. 

22 9. Documents reflecting actions taken by defendants as a result of the warning 

23 letter issued by FDA on July 13, 2015. 

24 10. Observations noted on FDA Forms 483, Lists of Inspectional Observations 

25 that were issued to you at the close of the FDA's inspections that are referenced in the 

26 warning letter issued by FDA on July 13, 2015. 

27 

5117670v1/26997-0001 

28 

7 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 22 of 55
EXHIBIT 17

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 23 of 55
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EXHIBIT 18

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 37 of 55
Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 38 of 55
Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 39 of 55
Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 40 of 55
EXHIBIT 19

To Plaintiffs’ Memorandum Re

Relevancy and Discoverability of FDA

Inspection and Warning Letter and

Recovery Cone Removal System

(part 1)

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 41 of 55
/ 

MA¥.11 .2 00 4 2: 02PM CC).E.e SA QA RA MA =Ac---------No. 77 82- P. 1 

."" 

C. R. BARD, INC. 

730 CENTRAL AVENUE 

MURRAY BILL, NJ 07974 

Fax# 908-277-8087 

Teli 908-277-8341 

E-Mail: paula. pizzi@crbard.eom 

TO: Mary Edwards 

FROM: Paula Pizzi for Paul Kowale.zyk 

DATE: May 11,2004 

"'*' 

NUMBER OF PAGES INCLUDING COVER SHEET: 56 

I transmission is not com 

COMMENTS: 

The infofmation conteined in this facsimile message ia legally privileged and confidential information intended only for the uae 

of the individual or entity n;)mod above. If the re~der of t~.i$ message iii not the intended recipient, you are hereby notified 

tha~ '''IV dissemination. distribution or copy of this f<~C"sim~e is ~~trictly prohibited. If vou have received thi$ f11csimlla in error, 

please immediately notify us by telephone and return the original messHge to us at the address above via the United St<~tes 

Pot:tal Service. Thank You 

CONFIDENTIAL -SUBJECT TO PROTECTIVE ORDER BPV-17-01-0016473

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 42 of 55
MAY. 11 . 2004 2:03PM 

CORP SA QA RA MA =AC _____ ___ --~ .. NO. 77 82-P. 2 

fvu:~~~age ... - , ... Page 1 of 2 

, ... , 

Church, Nikki 

From: Barry, Brian 

S~nt: Monday, May 10,2004 4:05PM 

To: 'Kimberly Ocampo'; Church, NikKi 

Cc: Ganser, Christopher; Kowalczyk, Paul 

Subject: RE: Latest Bard Filter Plan and Q&As 

Kimber1y: 

Hi, per my discussion with Chris Ganser, this piece will need to go through the standard Bard approval process for 

external pieces. 

To that end, per copy of this email I am fotwarding this piece to Nikki Church of our law Department, who coordinates 

such reviews. Nikki, please log and route per standard procedure. 

Thanks 

Brian 

Brian R. Barry 

V.P. Corporate Regulatory & Clinical Affairs 

C.R. Bard Inc. 

730 Central Avenue 

Murray Hill NJ 07974 

908-277 ·8062 

908-277-8087 (fax) 

908-472-5177 (cell) 

---··Original Message----· 

from: Kimberly Ocampo [mailto:kocempo@HillandKnowlton.com] 

sent: Monday, May 10, 2004 11:24 AM 

To: Barry, Brian 

Subject: FW: Latest Bard Filter Plan and Q&As 

Hello Brian. Please see below. I'm not sure if I was given the correct spelling of your last name. Thank you. 

----·Original Mes5a9e-----

From: Kimberly Ocampo 

Sent: Monday, May 10, 2.004 11:19 AM 

To: 'brian.berry@crbard.com' 

Cc: Lee Lynch; 'Glass, Holly'; 'jlehmann@lehmannthomas.com'; Passero, Donna; 'Hudnall, Janet'; 

'john. mc:dermott@crbard .com'; 'christopher .QCJilser@crbard.com'; 'doug. uelmen@c:rbard .com' 

Subject: Latest B<!td Filter Plan and Q&As 

Dear Brian: 

On behalf of the Bard Team currently involved with development of the crisis·plan and 

associated materials in support of the Recovery Filter, please review the attached 

draft communications plan, internal Q&A and external Q&A. These drafts incorporate the 

comments from the following: Dr. John Lehmann, Donna Passero, Janet Hudnall, John 

McDermott, Chris Ganser, Doug Uelmen and Holly Glass. 

Could you please provide your edits and comments to Hill & Knowlton (lee Lynch at 

llynch.@hilland~n9wltoo:~~9.fi or 571.214.8799 or myself) by close of business, Wednesday, 

May 12? If you have any questions about these documents, please contact Holly Glass, Lee 

5/10/2004 

CONFIDENTIAL -SUBJECT TO PROTECTIVE ORDER BPV-17-01-00164734 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 43 of 55
MAY. 11. 2004 2:03PM 

Message 

CQB.P SA QA RA MA =Ac i 

NO. 7782 P. 3 

Page 2 of 2 

or myself. 

Once we incorporate your changes. we will distribute the latest drafts to the entire team and 

schedule a call to discuss further edits next week. 

Thank you. 

Regards, 

Kimberly Ocampo 

Kimberly Ocampo 

Senior Account Supervisor 

Hill & Knowlton Washington, D.C. 

p: (202) 944 1905 

c: (202) 997 4420 

f: (202) 944 1970 

kimberly.ocampo@.l:l.il.I.<!Qdknowlton.co.m 

r::l1nJ'>nnA 

CONFIDENTIAL -SUBJECT TO PROTECTIVE ORDER 

HIL~WLTO 

"Bast inloternation.al PR · ~ Tnoma!J L. Harnsl/mpulse Resecm;IJ 

BPV-17-01-00164735 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 44 of 55
MAY.11.2004 2:03PM \~~p SA QA RA MA =Ac NO. 7782 P. 4 

, .. 

Hll~WLTON 

MEMO 

To: Holly Glass, Chris Ganser, Janet Hudnall, Donna Passero and 

Brian Berry 

From: Lee lynch and Kimberly Ocampo 

Date: May 10,2004 

Subject: Recovery Filter Crisis Communications Plan 

This document provides a step-by-step guide for implementing an immediate 

communications strategy to ensure C.R. Bard is prepared for any news coverage that 

may result from pending investigations surrounding the Recovery Vena Cava Filter. 

The information presented in this plan is privileged and confidential and is for internal 

use only. 

HILL & KNOWLTON 600 New HampshiM Avenue, NW 

Suite601 

Washington. DC 20037 

CONFIDENTIAL- SUBJECT TO PROTECTIVE ORDER 

T 202 333-7400 

F 202 333-1638 

BPV-17-01-00164736 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 45 of 55
MA Y. 11.2 004 2:03PM ~~p SA QA RA MA =Ac 

""'/ 

RECOVER~ FILTER CRISIS COMMUNICATIONS PLAN 

OVERVIEW 

..... NO. 7782 P. 5 

5/10/04 

As with previous crisis plans Hill & Knowlton has prepared for C. R. Bard, this guide will 

help Bard's Corporate Communications Team prepare for and properly manage 

controversial or negative stories surrounding the Recovery® Vena Cava Filter. 

The proliferation of unfavorable press in top-tier media outlets can cause an onslaught 

of negative activity: a company's employee morale may suffer, stock prices may 

plummet, analysts may downgrade the affected company's rating, and longstanding 

reputations may be ruined temporarily or even permanently. Extensive preparation is 

critical to help prevent the spread of damaging coverage. 

Currently, Bard is investigating the reported migration of the Recovery Vena Cava Filter 

in.two separate incidences . . Vl 1....-1'-l: <... 

The first reported incident under investigation took place ~Baptist IIOSfJit!l ef Miarm---W 'v ~ 

·-ft'. following bariatric sur:gery. T!l~ coroner's report state that filter migration..tsifie t 

cause of death. Bard)s"'"conduc~its own investigations to research the validity of this , 

claim and h~. tut<e BrennEmke of ~atholegy Associates in Frederick, Mlhcr ~"' 1".").'{:J 

conduct a subsequent pa. thological evaluation of the thrombus surrounding the vena Jth l · .. Acava filter removed during the autopsy. - ··· · '-c c~ 6 1 

! 1---<( 1'-<.,0 

~ { C C/·~· ' - · tJ.... · ") \,~ I _,_ -~ 

Thecsu mary pmviaed iA tt'le CMP12933 PATH Report signed byfir.-Brennecke--

follows: 

The clot formation was an ante mortem event; it had most likely been deposited around the 

device over a period of a couple of days. The location of the device during clot deposition could 

not be determined. The bacterial coloniZing the Clot most likely represents post mortem growth 

of normal saprophytic bacteria. Because extensive (destroctive) sampling of the clot was 

prohibited (telephonic instructions), no tissue was sampled from around the hooks that were still 

embedded within the clot. Should they be sampled, it is possible that segments of the mural 

itecture IVC or elsewhere) might be present. ~ "'~ -- ------- -- --·--·---·-··---· .... 

It is important to note that, according to hospital records, the patient was a morbidly 

obese An* weighing between 450 - 500 lbs. The filter was placed in a normal sized 

~ 

vena cava and there were no immediate complications. ~COfQj.ln .. g: · ~a-1::~\Gki~:::::::::... 

the filter was found to be intact, and the la.!9!Ltllm bus surrouf1dinQ) 

\__ the_!!!!er w~xim~Iy 10 cm_l9.!!.Q_X 30W't!.lr)jlameter( To date). c;·rormallawsuit 

1fi5m ffief8nlily of the , eceased has been filed IV-'-

HILL & KNOWLTON 

/'1,·,.._.. ' \j '1'~~ 

800 New H;,mpshire Avenue, NW 

Suite601 

Washington. DC 20037 

CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER 

T 202 333-7400 

F 202 333-1638 

2 

BPV-17-01-00164737 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 46 of 55
MAY. 11. 2004 2:03PM ~P SA QA RA MA =Ac 

"' 

NO. 7782 P. 6 

The second incident took place in Grand Rapids, MI. From the information available to 

date, we know that the Recovery Filter was placed in a female patient for deep vein 

thrombosis. The filter had been placed approximately 13 days prior to death, March 31, 

2004. The patient was then released from the hospital on April6, 2004 and expired on 

April13, 2004. The medical examiner's report states that the cause of death is cardiac 

rupture as a result of a puncture to the right ventricle by an inferior vena cava filter. 

ff"· ~ 

The size of the clot at the time of the autopsy was approximately f-Jcm in diameter by 5() 

~ in length. There were no design or manufacturing defects found to be associated 

with the filter. The BPV Product Assessment Team has concluded that the Recovery 

Filter captured a large embolic load with resulting increase in venous pressure that lead 

to inferior vena cava dilation greater than 28 mm resulting in migration. Final autopsy 

report will be available during the week of May 4. 

The attached pages provide recommendations and critical information relating to the 

following components of your crisis communications program: 

• I. Re-distributing Bard's Communications Policy 

• II. Media Monitoring 

• Ill. Message Approval 

• IV. Establishing A Core Response Team 

• V. Audience Outreach T earn 

• VI. Top Media Interview Dos and Don'ts 

• VII. External Allies/Experts 

• VIII. Key Studies 

• IX. News Breakdown 

• X. Newsmaker's Bill of Rights 

• XI. Proactive Media Outreach 

• XII. Step-by Step Management of Most Likely Scenarios: 

• XIII. H&K Team Contact Information 

• Addendum: 

o A. Key Messages - Recovery Vena Cava Filter: General Messages 

o B. Key Messages for Specific Incidents: 

• Specific to Miami Incident 

1 Specific to Grand Rapids, M I Incident 

1 Specific to Both Incidents 

o C. Draft General Letter-To-The-Editor 

o D. Draft Miami Letter-To-The-Editor 

o E. Draft Miami Letter-To-The-Editor 

o F. Media Lists 

o G. Recent Sample Article: Bariatric Surgery in General 

HIU & KNOWLTON 600 New Hampshire Avenue, NW 

Suite 601 

Weashington, DC 20037 

CONFIDENTIAL -SUBJECT TO PROTECTIVE ORDER 

T 202 333-7 400 

F 202 333-1638 

3 

BPV-17-01-00164738 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 47 of 55
MAY. 11. 2004 2:04PM C,Q.lf SA QA RA MA =Ac NO. 77 82 P. ~ 

I. Re-distributing Bard's Communications Polic~ 

To prevent any Bard employee from speaking with members of the media, it would be 

wise to redistribute Bard's communications policy company-wide twice each year 

beginning with 2Q 2004. If Bard is notified that a lawsuit has been filed, dissemination 

of the communications policy again specifically to the Bard Peripheral Vascular Division 

as well as C.R. Bard Corporate employees, should be considered. 

Anyone who may be most likely to receive phone calls from members of the media 

(e.g., administrative staff for corporate executives and field sales representatives who 

sell vena cava filters) must have copies of the communications policy and should be 

required to sign a confirmation form that they have read and understand these 

guidelines. 

All Bard employees must know to direct any media inquiries directly to Holly Glass. 

With the communications guidelines redistributed several times each year, employees 

will have this information top-of-mind. 

HILL & KNOWLTON 600 New 11<!mp:':lhire Avenue, NW 

Suite 601 

Washington, DC 20037 

CONFIDENTIAL -SUBJECT TO PROTECTIVE ORDER 

T 202 333-7400 

F 202 333-1638 

4 

BPV-17-01-00164739 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 48 of 55
MAY. 11. 200 4 2: 04PM C9RP SA QA RA MA =Ac 

.-~ 

11. Media Mo11,itoring 

NO. 77 82 P. 8 

H&K has begun monitoring regularly for any print, broadcast and online news coverage 

related to the company or the Recovery Vena Cava Filter. To do this effectively, H&K is 

using the Factiva database, Google News and Video Monitoring Services (VMS). 

Particular emphasis is placed on news generated from the following markets: greater 

New York City (Bard Corporate HQ); Tempe, Arizona (Bard Peripheral Vascular HQ); 

Miami, Florida (location of case under investigation) and Grand Rapids, Michigan 

(location of case under investigation). 

We are searching for the following terms. 

• C.R. Bard 

• Bard Peripheral Vascular 

• Recovery Vena Cava Filter 

• Vena cava filter 

• Pulmonary embolism 

• Baptist Hospital (Miami, FL) 

Ill. Message Approval 

• Miami Cardiac & Vascular 

Institute (MCVI)!NA11 

• [NAME OF LAW FIRM FILING 

SUIT IF SUIT IS FILED] 

• Any filter mentions in Grand 

Rapids, Ml 

Key messages (~~~ ~tic; ~ijl( tp_i~iriiiii~ji.;j_(~?~O serve as the foundation 

for responding during any media interviews that may arise as a result of the pending 

investigations. It is critical that this messaging be updated as new details arise. 

The approved messaging will be incorporated into external materials that will be 

distributed to Bard's sales force, customers, physicians, employees, suppliers and 

others, as needed. Bard is then prepared to handle any media inquiries. Furthermore, 

H&K's on-camera Q&A Training will help prepare spokespeople for any local or trade 

press inquiries that are posed: additional"on .. the-spot" training and messaging 

discussions should be considered prior to responding to national top-tier press inquiries. 

HILL & KNOWLTON 600 New Hampshire Avenue, NW 

Suite601 

Washington, DC 20037 

CONFIDENTIAL- SUBJECT TO PROTECTIVE ORDER 

T 202 333--7400 

F 202 333-1638 

5 

BPV-17-01-001647 40 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 49 of 55
MAY. 11. 200( 2: 04PM C9,.RP SA QA RA MA =Ac 

......... 

NO. 7782 P. 9 

IV. Establishing A Recovery Core Vena Cava Filter Response Team 

The following Bard and H&K employees should comprise the Core Response T earn 

(CRT) for the Recovery Vena Cava Filter product. These individuals will receive 

notification when a press inquiry is received or when a negative article requiring action 

appears. This group will convene within several hours to approve response strategy, 

review specific messaging and determine next steps. 

Core Response Team: Phone Numbers: 

Holly Glass Office-703-754-2848 

Cell-571-243-1952 

Home-571-261-1425 

Janet Hudnall Office-480-303-2630 

Cell-602-881-1331 

Donna assero Office-908-277 -8335 

Cell-908-803-9346 

Home-973-394-0052 

Chris Ganser Office-908-277 -9338 

Cell-908-568-9411 

Doug Uelmen 

John McDermott 

Rob Carr 

Brian 

AdjunctJohn Lehmann, MD 

Frank Man 

Lee Lynch 

Kimberly Ocampo 

HILL & KNOWLTON 

Fax-908-277-8087 

600 New Hampshire A11enue, NW 

Suite 601 

Washington, DC 20037 

CONFIDENTIAL- SUBJECT TO PROTECTIVE ORDER 

E-mail Address: 

holly .glass@crbard .com 

janet.hudnall@crbard.com 

donna.passero@crbard.com 

doug.uelmen@crbard .com 

john .mcdermott@crbard .com 

robert.carr@crbard.com 

jlehmann@lehmannthomas.com 

.com 

llynch landknowlton.com 

T 202 333-7400 

F 202 333-1638 

6 

BPV-17-01-001647 41 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 50 of 55
MAY. 11 . 2004 2: 04PM C.Ql P SA QA RA MA =Ac . 77 82 P. :0 

CRT Conference Calls 

The following telephone line Is available 24 hours a day, seven days a week for the 

CRT to use for conference calls. 

• Toll Free Dial-In Number. 1-888-453~5732 

• Participant Passcode: 500965 

V. Recovery Vena Cava Filter Audience Outreach Team 

Depending on the situation, the CRT may determine that there is a critical need to 

contact other key audiences outside of this immediate response group. To facilitate 

effective and efficient communications among the various company divisions and 

appropriate external audiences, a point-of-contact has been designated to conduct this 

outreach. They are: 

Audience Outreach Team: Phone Numbers: 

Additional Media: Office-703-754-2848 

Holly Glass Cell-571-243-1952 

Home-571-261-1425 

CEO and Board of Directors: Office-703-754-2848 

Holly Glass Cell-571-243-1952 

Home-571-261-1425 

Recovery Filter Field Sales Janet: 

Reps: Office-480-303-2630 

Janet Hudnall Cell-602-881-1331 

Carol Stone 

Carol: 

Office-908-277 -8301 

Cell-908-507-6574 

Home--908-526-5579 

Recovery Filter Physic:ians: Office-480-303-2630 

Janet Hudnall Cell-602 4381-1331 

Customers and Field Reps: Office-480-303-2630 

Janet Hudnall Cell-602-881-1331 

All Other Employees: Office-908-277 -8191 

Diana McHugh Cell-908-571-2841 

Home-908-835-01 07 

Suppliers/Operations: Office-908-277 -8177 

Frank Maloit Cell-908-528-3537 

Home-61 0-330-9082 

Home-781·837~9530 

Shareholders and Wall Street: Office-908-277 -8413 

Eric Shick Cell-908-256-4238 

Office- 908-277-8265 

HlLL&KNOWLTD~ 600 ~w Hampshi·eAvenue, NW 

Suite 601 

Washington, DC 20037 

CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER 

E-mail Address: 

holly .glass@crbard.com 

holly.glass@crbard.com 

janet.hudnall@crbard.com 

carol.stone@crbard.com 

janet.hudnall@crbard.com 

janet.hudnall@crbard.com 

diana.mchugh@crbard.com 

frank. maloit@crbard .com 

eric.shick@crbard .com 

T 202 333-7400 

F 202 333-1638 

7 

BPV-17-01-001647 42 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 51 of 55
MAY. 11. 2004 2:05PM C,QaP SA QA RA MA =Ac NO. 7782 P. 11 

VI. Top Media Interview Dos and Don'ts 

Following is a list of general dos and don'ts for interviews with major top media outlets. 

Dos 

• Offer a physician spokesperson for comment. 

• Offer a researcher, patient or corporate executive for further insight. 

• Offer medical studies validating Recovery Vena Cava Filters or retrievable vena 

cava filters in general. 

• Ask for a list of questions, parameters of the story and permission to record your 

own v1deo of the interview or any interviews with Bard employees, patients or 

physicians. 

• Offer video of Bard's headquarters, if you already have a tape available. 

• Manage the story. Draw the line at non-company spokespersons, "trial 

witnesses", salespersons, product designers, etc. 

• Stay focused on the success rate and clinical effectiveness of the products, 

rather than the claims. Stick to your key messages. 

• Include day-before and day-of key audience notification in your communications 

strategy. Assume key audiences such as employees, physicians, shareholders, 

customers and field sales reps will see the story. Be prepared to notify them 

about when the segment will air or has just aired, and provide a clear, convincing 

cover letter with your key messages. as well as a breakdown of comments made 

in the story matched with corresponding facts. 

Oonts 

• Play favorites with the members of the media. 

• Answer a question with ''No Comment." 

• Don't try to minimize the problem. 

• Don't release sensitive or proprietary information. 

HILL & KNOWLTON 600 New Hampshire Avenue, NW 

Suite601 

Washingron. DC 20037 

CONFIDENTIAL- SUBJECT TO PROTECTIVE ORDER 

T 202 333-7400 

F 202 333-1638 

8 

BPV-17-01-001647 43 

Case 2:15-md-02641-DGC Document 988-2 Filed 03/04/16 Page 52 of 55
MAY. 11. 2004 2:05PM C~ SA QA RA MA :Ac · 

NO. 7782 P. . 2 

VII. External Allies/Experts 

Physician Spokespeople 

If a reporter calls for comment, Bard should have reputable physicians confirmed to 

participate In interviews to attest to the product's success rate and the value it provides 

to patients. 

The below physician has been identified to serve as a spokesperson who can speak to 

the value of the filter. 

Gary S. Cohen, MD 

Chief, lnterventional Radiology &"" 

Temple University Medical Center . " 

3401 N. Broad St. 

Philadelphia, PA 19140 

(215) 707-3951 

cohenatoJ@aol. com 

Third Party Industry Organizations and Potential Allies 

Board members and other prominent leaders from ally organizations may be able to 

lend their credibility to Bard by providing ally spokespersons who can speak to the value 

of the retrievable Recovery Vena Cava Filter products (or retrievable vena cava filters in 

general) and Bard's position as a leader both in terms of innovation and customer 

care/safety. Allies may include representatives from the following organizations: 

• Society of lnterventional Radiology 

• Association for the Advancement of Medical Instrumentation 

• Medical Device Manufacturers Association 

• Society for Vascular Surgeons 

We currently are researching whether these organizations would be willing to speak to 

the media if an inquiry arises. For regional or local media outlets, it may be necessary 

to provide local sources. As the scenario develops, we may work with other third-party 

associations to determine local spokespeople. 

In addition. Bard may want to consider either securing the partnership of a general 

medical device or consumer organization that can speak broadly about the value of 

Bard•s products for consumers, such as: 

• The Medical Device Manufacturers Association 

• Center for Consumer Affairs or 

• American Council on Consumer Interests (ACCI) 

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Finally, another consideration is for Bard to create a third-party organization that 

focuses on the enormous benefit of medical progress for consumers to override the 

negative perceptions created through a few (often frivolous) lawsuits. 

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VIII. Key Studies 

Two studies are available specific to the Recovery Filter. 

The Recovery Filter has been used in Canada by a single investigator and two 

colleagues at six Toronto area hospitals in 58 subjects, under the Special Access 

regulations. Although essentially only one physician used the device, removal was 

performed by three physicians with different support staff and imaging equipment. 

Of the 58 filters implanted, a total of 46 have been retrieved, 8 remain in place, and 4 

!NA2Jpatients have died with filters in place of causes unrelated to filter placement or 

retrieval (leukemia, cancer, polyarteritis and pulmonary aspergillosis, and hemorrhagic 

stroke). Time to removal ranged from 1 to 161 days, average 60 days. 

In addition, the Recovery Filter underwent testing (bench top or animal studies or a 

combination of both) according to FDA guidelines to obtain FDA concurrence. 

Summaries of key medical studies highlighting the success rate of Bard's Recovery 

Vena Cava Filter products and other vena cava filters can be found in the appendix. 

We have produced three separate sections of summarized studies: one focuses on the 

success of (permanent) [NAJJVena cava filters in general; the second focuses on 

retrievable vena cava filters as a whole; and the third details studies on Bard's Recovery 

Vena Cava Filter specifically. These summaries will serve as handouts and references 

for the media. 

IX. News Breakdown 

There are many various forms a news story can take and often one precedes another. 

To understand how news stories are originally generated and often end up featured on 

weekly news magazine shows, an explanation of how the media generally works is 

provided below. Please note there are always exceptions to the standards. 

Wires- Associated Press, Bloomberg, Dow Jones, Reuters 

National Dailies- USA Today, New York Times, Wall Street Journal 

Top Market Dallies~ Los Angeles Times, Boston Globe, Washington Post 

Trades- The Gray Sheet MODI, Medical Device Litigation Reporter 

News Magazine- U.S. News & World Report, Time, Newsweek 

Daily News Program- Dateline, World News Tonight 

Weekly News Program- 60 Minutes, 60 Minutes II, 48 Hours Investigates, 20/20 

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