Exhibit C-1

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 1 of 36
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 1 (1)

 1 IN THE UNITED STATES DISTRICT COURT

 2 FOR THE DISTRICT OF ARIZONA

 3 - - -

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

 PRODUCTS LIABILITY LITIGATION :

 5

 6

 7 - - -

 8 MARCH 21, 2017

 9 - - -

 DO NOT DISCLOSE - SUBJECT TO FURTHER

 10 CONFIDENTIALITY REVIEW

 11 Videotape deposition of MARCUS

 12 D'AYALA, M.D., taken pursuant to notice, was held at

 13 the law offices of Aaronson Rappaport Feinstein &

 14 Deutsch, LLP, 600 Third Avenue, New York, New York

 15 10016, beginning at 12:45 p.m., on the above date,

 16 before Amanda Dee Maslynsky-Miller, a Certified

 17 Realtime Reporter and Notary Public in and for the

 18 State of New York.

 19

 20 - - -

 21

 22

 23

 GOLKOW TECHNOLOGIES, INC.

 24 877.370.3377 ph | 917.591.5672 fax

 deps@golkow.com

 25

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 2 of 36
Page 2

 1 APPEARANCES:

 2

 3 MATTHEWS & ASSOCIATES

 BY: DAVID P. MATTHEWS, ESQUIRE

 4 2905 Sackett Street

 Houston, Texas 77098

 5 Dmatthews@dpmlawfirm.com

 Representing the Plaintiff,

 6 Sherr-Una Booker

 7

 8 AARONSON RAPPAPORT FEINSTEIN AND DEUTSCH, LLP

 BY: PHILIP D. LERNER, ESQUIRE

 9 600 Third Avenue

 5th Floor

10 New York, New York 10016

 (212) 593-6700

11 Pdlerner@arfdlaw.com

 Representing the Witness,

12 Marcus D'Ayala, M.D.

13

14

15 NELSON MULLINS RILEY & SCARBOROUGH LLP

 BY: ELIZABETH C. HELM, ESQUIRE

16 Atlantic Station

 201 17th Street NW

17 Suite 1700

 Atlanta, Georgia 30363

18 (404) 322-6000

 Kate.helm@nelsonmullins.com

19 Representing the Defendant,

 C.R. Bard, Inc. and Bard Peripheral Vascular

20

21

22

23

24

25

Page 3

 1 APPEARANCES: (Continued)

 2

 3 THE NATIONS LAW FIRM

 BY: SHELLEY J. BLAS, PARALEGAL

 4 1512 Larimer Street

 Suite 710

 5 Denver Colorado 80202

 (720) 287-5300

 6

 7

VIA TELECONFERENCE:

 8

 9 NELSON MULLINS RILEY & SCARBOROUGH LLP

 BY: CHRISTOPHER "SHAUN" POLSTON, ESQUIRE

10 Atlantic Station

 201 17th Street NW

11 Suite 1700

 Atlanta, Georgia 30363

12 (404) 322-6000

 Shaun.polston@nelsonmullins.com

13 Representing the Defendant,

 C.R. Bard, Inc.

14

15

16 LOPEZ McHUGH, LLP

 BY: RAMON ROSSI LOPEZ, ESQUIRE

17 100 Bayview Circle

 Suite 5600

18 Newport Beach, California 92660

 (949) 737-1501

19 Rlopez@lopezmchugh.com

 Representing Plaintiffs

20

21

22

23

24 ALSO PRESENT: Kevin Pollard, Videographer

25

Page 4

 1 - - -

 2 I N D E X

 3 - - -

 4 Testimony of: MARCUS D'AYALA, M.D.

 5

 By Mr. Matthews 7, 122

 6 By Ms. Helm 77, 127

 7

 8 - - -

 9 E X H I B I T S

10 - - -

11

NO. DESCRIPTION PAGE

12

Exhibit-1 Curriculum Vitae,

13 Marcus D’Ayala 17

14 Exhibit-2 BPVE-01-01019821-825

 Health Hazard Evaluation,

15 Dated 12/17/04 36

16 Exhibit-3 BPVE-01-01019773-784

 Recovery Filter Migration,

17 Dated 1/4/05 37

18 Exhibit-4 IFU, G2 Filter System 47

19 Exhibit-5 Eastern Vascular Society,

 Concurrent Prophylactic Placement

20 of Inferior Vena Cava Filter In

 Gastric Bypass and Adjustable

21 Banding Operations in the

 Bariatric Outcomes

22 Longitudinal Database 55

23 Exhibit-6 NEJM, A Clinical Trial of Vena

 Caval Filters in the Prevention

24 of Pulmonary Embolism in Patients

 With Proximal Deep-Vein

25 Thrombosis 58

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 2 (2 - 5)

Page 5

 1

 - - -

 2

 E X H I B I T S

 3

 - - -

 4

 5 NO. DESCRIPTION PAGE

 6 Exhibit-7 AMA, Prevalence of Fracture

 and Fragment Embolization of Bard

 7 Retrievable Vena Cava Filters And

 Clinical Implications Including

 8 Cardiac Perforation

 and Tamponade 64

 9

Exhibit-8 BOOKERS_NYMH_MDR00057-461

10 Medical Records 71

11 Exhibit-9 *Skipped*

12 Exhibit-10 *Skipped*

13 Exhibit-11 BPV-DEP-00004804-4806

 12/27/05 E-Mail from David

14 Ciavarella to Brian Barry 73

15 Exhibit-12 Fractured Bard Recovery, G2, and

 G2 Express Inferior Vena Cava

16 Filters: Incidence, Clinical

 Consequences, and outcomes of

17 Removal Attempts 123

18 Exhibit-13 Evidence-Based Evaluation of

 Inferior Vena Cava Filter

19 Complications Based on Filter

 Type 124

20

21

22

23

24

25

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 3 of 36
Page 6

 1 - - -

 2 DEPOSITION SUPPORT INDEX

 3 - - -

 4

 5 Direction to Witness Not to Answer

 6 Page Line Page Line Page Line

 7 None

 8

 9

10 Request for Production of Documents

11 Page Line Page Line Page Line

12 None

13

14

15 Stipulations

16 Page Line Page Line Page Line

17 7 1

18

19

20 Question Marked

21 Page Line Page Line Page Line

22 None

23

24

25

Page 7

 1 - - -

 2 (It is hereby stipulated and agreed

 3 by and among counsel that sealing, filing and

 4 certification are waived; and that all objections,

 5 except as to the form of the question, will be

 6 reserved until the time of trial.)

 7 - - -

 8 VIDEO TECHNICIAN: We are now on the

 9 record. My name is Kevin Pollard, and I'm a

10 videographer for Golkow Technologies. Today's date

11 is March 21, 2017, and the time is 12:45 p.m.

12 This video deposition is being held

13 in New York, New York, in the matter of CR Bard IVC

14 Filters Products Liability Litigation. The deponent

15 is Marcus D'Ayala, MD.

16 Counsel will be noted on the

17 stenographic record. The court reporter is Amanda

18 Miller and will now swear in the witness.

19 - - -

20 MARCUS D'AYALA, M.D., after having

21 been duly sworn, was examined and testified as

22 follows:

23 - - -

24 EXAMINATION

25 - - -

Page 8

 1 BY MR. MATTHEWS:

 2 Q. Could you state your name, please?

 3 A. Marcus D'Ayala.

 4 MS. HELM: Dave, before we get

 5 started, I have to address the failure to -- I just

 6 want to address on the record very quickly the

 7 failure to comply with the CMO relating to the

 8 identification of documents.

 9 It appears that it may not be an

10 issue, based on conversations we had prior to the

11 deposition. But on March 14th, I received a letter

12 identifying documents that have been or may be

13 provided to Dr. D'Ayala pursuant -- prior to his

14 deposition. On March 17 at 1:50 a.m., less than

15 five days before this deposition, I received a list

16 from plaintiffs' counsel of 27 documents that you

17 identified that you intended to use at the

18 deposition, including an expert report that contains

19 hundreds of documents.

20 On Sunday, March 19th at 11:30 p.m.,

21 less than two days before the deposition, I received

22 another list of 13 documents that plaintiffs may use

23 during the deposition. In all, plaintiffs

24 identified more than 40 documents, which the CMO

25 only allows for 40, and they've identified at least

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 3 (6 - 9)

Page 9

 1 40 of them after the deadline set by the court.

 2 Finally, we were served with a

 3 deposition notice that said the deposition was at

 4 10:00 a.m., and the subpoena to the doctor was for

 5 1:00 p.m., and we received an amended notice

 6 yesterday that was dated March 16th that cleared it

 7 up.

 8 Again, I don't think it's going to be

 9 an issue, based on the conversation we had prior to

10 the start of the deposition. But to the extent it

11 becomes an issue, obviously, Bard is reserving our

12 rights and, unfortunately, the right to reconvene if

13 we have to.

14 Doctor, I hope we don't have to, but

15 we are under procedures and orders in this case and,

16 unfortunately, they haven't been followed. So I

17 have to take that position.

18 MR. MATTHEWS: I understand. I did

19 try to clear up, prior to the deposition, the

20 documents that we anticipate using, which are quite

21 a bit fewer than the documents identified. Some of

22 those identified might be used in rebuttal, if, for

23 instance, you ask about a certain document.

24 That said, we anticipate using

25 approximately ten documents today.

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 4 of 36
Page 10

 1 MS. HELM: And I understand that.

 2 But I think you understand that it is our position

 3 that the plaintiffs have failed to comply with the

 4 CMO. And, as a result, to the extent there's any

 5 prejudice to Bard, I have to reserve any rights that

 6 we have.

 7 MR. MATTHEWS: I understand.

 8 Are we ready to go?

 9 THE WITNESS: Yes.

10 BY MR. MATTHEWS:

11 Q. Let's start over.

12 Doctor, could you state your name,

13 please?

14 A. Marcus D'Ayala.

15 Q. And what do you do, sir?

16 A. I'm a vascular surgeon in clinical

17 practice in Brooklyn, New York.

18 Q. And you live in Brooklyn?

19 A. I live in Long Island and Brooklyn,

20 correct.

21 Q. Okay. Have you given a deposition

22 before today?

23 A. I have.

24 Q. All right. In what matter or

25 matters?

Page 11

 1 A. I have been called to give

 2 depositions in legal matters involving several

 3 patients. I don't have any specific recollection of

 4 any of them. None of these matters ever came to

 5 court or were dealt with in any other way other than

 6 just being disposed.

 7 I'm not so sure as to what the legal

 8 term is, but a couple of depositions, and that was

 9 the extent of it. No more than two or three, I

10 would say.

11 Q. Have you ever testified in a case

12 involving a medical device?

13 A. No.

14 Q. Have you ever consulted with any

15 medical device companies?

16 A. I'm not so sure I understand your

17 question.

18 Q. Have you been a consultant to any

19 company that manufacturers medical devices?

20 A. In terms of providing them with

21 expert advice regarding their products? No.

22 Q. Are you currently a consultant with

23 any medical device company?

24 A. I am not.

25 Q. Where do you practice medicine?

Page 12

 1 A. I practice at New York-Presbyterian

 2 Brooklyn Methodist Hospital, which was formerly

 3 known as New York Methodist Hospital. We were

 4 recently acquired and, hence, the name change.

 5 Q. Okay. Is that the only hospital that

 6 you have privileges?

 7 A. It is.

 8 Q. Today I think we'll just call it New

 9 York Methodist, if that's okay.

10 A. Perfectly fine.

11 Q. It seems quite a bit easier.

12 MR. LERNER: I'm sure they'll be

13 happy if you just call it Methodist.

14 MR. MATTHEWS: All right. We'll just

15 call it Methodist then. Fair enough.

16 BY MR. MATTHEWS:

17 Q. Are you a full-time clinician?

18 A. I am.

19 Q. You do not teach?

20 A. I do teach.

21 Q. What percentage of your time do you

22 spend teaching?

23 A. I would estimate it to be about 20

24 percent.

25 Q. So Methodist is a teaching hospital?

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 4 (10 - 13)

Page 13

 1 A. It is.

 2 Q. All right. The other 80 percent of

 3 the time, you are a clinician; that is, you spend

 4 time treating patients?

 5 A. Correct.

 6 Q. All right.

 7 A. With a small amount of that time

 8 dedicated to administration of our division.

 9 Q. Okay. Doctor, I represent Sherr-Una

10 Booker. She was a patient of yours back in 2007.

11 You, at that time, implanted a G2, Bard G2 IVC

12 filter.

13 I suspect you do not recall her

14 personally?

15 A. I do not.

16 Q. Have you had a chance to look at the

17 records, your records, of the implant and the

18 procedure that took place back in 2007?

19 A. I have.

20 Q. Other than the review of the medical

21 record, your medical record wherein you implanted

22 this Bard G2 in Ms. Booker, did you look at any

23 other medical records?

24 A. I did.

25 But for the sake of clarity, I must

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 5 of 36
Page 14

 1 say it's not my record, it's the hospital's record.

 2 Q. So you reviewed some hospital record

 3 as well as your own medical record --

 4 MR. LERNER: No. No.

 5 BY MR. MATTHEWS:

 6 Q. -- at one point?

 7 MR. LERNER: It's not his records,

 8 it's only the hospital record. He doesn't have his

 9 own personal private records for the patient.

10 BY MR. MATTHEWS:

11 Q. Right. So you only reviewed the

12 hospital records?

13 A. Correct.

14 Q. Okay. Any --

15 A. Just so as to be clear in this

16 regards, I saw her as an inpatient, in hospital, and

17 I had an opportunity to review those records. I did

18 not see her as an outpatient or in my private

19 practice.

20 Q. Okay. In reviewing those records,

21 were you able to identify the doctor who actually

22 ordered the implant?

23 A. I'm not so sure I fully understand

24 that question. I can tell you that I know the

25 doctor that asked us to see this patient in

Page 15

 1 consultation.

 2 Q. Who was that doctor?

 3 A. Dr. Dean Martin.

 4 Q. And what type of doctor is Dr. Dean

 5 Martin?

 6 A. He is an obstetrician/gynecologist.

 7 Q. Had he referred or consulted with you

 8 prior to that time?

 9 MR. LERNER: About different

10 patients, you mean?

11 MR. MATTHEWS: Yes, about other

12 patients.

13 THE WITNESS: Yes.

14 BY MR. MATTHEWS:

15 Q. Had he consulted with you about the

16 use of IVC filters on prior occasions?

17 A. Yes.

18 Q. Today I'm here to ask you, really,

19 about three areas of inquiry; your treatment of Ms.

20 Booker, the decision to use the G2 filter, and then

21 what warnings you had, prior to implanting the

22 filter, about the risks and the benefit of the G2

23 filter.

24 Do you understand those three areas?

25 A. Yes.

Page 16

 1 Q. Have you reviewed anything else in

 2 preparation for your deposition today? You told is

 3 about the Methodist medical record.

 4 Any other documents or anything at

 5 all prior to this deposition?

 6 A. There are two documents that I

 7 reviewed just this morning, the Methodist medical

 8 record and the medical record from, I believe it was

 9 Gwinnett Hospital.

10 MS. HELM: Gwinnett.

11 THE WITNESS: Gwinnett Hospital.

12 MR. MATTHEWS: Do you have those with

13 you.

14 MR. LERNER: I have them in my

15 office, yes. They were copies that you guys

16 provided to us.

17 MR. MATTHEWS: All right. I just

18 wanted to make sure what we were talking about. If

19 there's something else in there, I would --

20 MR. LERNER: On the record, they were

21 provided to me by your office.

22 MS. HELM: In the flurry?

23 MR. LERNER: Yes.

24 MR. MATTHEWS: Very good.

25 BY MR. MATTHEWS:

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 5 (14 - 17)

Page 17

 1 Q. Doctor, you brought a C.V. with you

 2 today. We're going to mark that as Exhibit-1 to

 3 your deposition.

 4 MR. MATTHEWS: And I will mark in

 5 succession deposition exhibits, and we'll attach

 6 those to your deposition today, all right?

 7 A. Sure.

 8 - - -

 9 (Whereupon, Exhibit-1, Curriculum

10 Vitae, Marcus D’Ayala, was marked for

11 identification.)

12 - - -

13 BY MR. MATTHEWS:

14 Q. Is Exhibit-1 a current, up-to-date,

15 accurate copy of your C.V.?

16 A. Yes.

17 Q. It says you're the chief of vascular

18 surgery at Methodist Hospital, previously at

19 University of Texas Health Science Center in San

20 Antonio. Prior to that, chief of vascular surgery,

21 Bronx VA Hospital.

22 That's all correct?

23 A. Yes.

24 Q. In terms of IVC filter literature,

25 that is, a study or medical document that you

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 6 of 36
Page 18

 1 produced, I have seen that you have two studies

 2 concerning the IVC filters; is that correct?

 3 MR. LERNER: Are you talking about in

 4 his publication list?

 5 MR. MATTHEWS: His publication

 6 section of his C.V.

 7 THE WITNESS: Yes, that is correct.

 8 BY MR. MATTHEWS:

 9 Q. You don't have anything more current

10 that may be not listed on here?

11 A. No, I do not.

12 Q. You were provided a copy of a

13 confidentiality or protective order, and I think we

14 had asked your attorney if you had signed that prior

15 to this deposition. And I don't know if that

16 occurred.

17 MR. LERNER: He wasn't provided with

18 it, I was. And I didn't ask him to sign it. I

19 apologize, that's just my omission. So if you have

20 one, I suspect he's happy to sign it now.

21 I looked at it, Doctor, there's --

22 THE WITNESS: If Mr. Lerner is happy,

23 I'm happy.

24 MR. LERNER: I'm never happy, so

25 don't go by that standard.

Page 19

 1 MR. MATTHEWS: We are going to -- I

 2 am handing this to your lawyer Mr. Lerner.

 3 MR. LERNER: For your benefit, I was

 4 amused on your client's questionnaire answer, it

 5 says Carnarsie High School in the Bronx; Carnarsie's

 6 in Brooklyn. No one in New York would ever accept

 7 that as accurate. You guys should know that.

 8 MR. MATTHEWS: Note taken. I'm from

 9 Wisconsin, so what do I know?

10 MR. LERNER: So he's signing Page 16,

11 correct, is that what you'd like? Or do you want

12 18?

13 MS. HELM: He needs to sign --

14 MR. LERNER: 18 or 16 or both?

15 MS. HELM: I'm sorry. It's just 16.

16 MR. LERNER: Doctor, at the bottom,

17 it's self-explanatory.

18 Do you have a pen?

19 THE WITNESS: No, I do not.

20 Thank you.

21 MR. LERNER: So what you're signing

22 away is don't talk about this outside of this room.

23 THE WITNESS: Understood.

24 MR. LERNER: Except to me, I guess.

25 THE WITNESS: The 21st?

Page 20

 1 MS. HELM: Yes, sir. He's going to

 2 be shown -- apparently going to be shown some

 3 internal documents from Bard, and he just has to

 4 agree to maintain that confidentiality.

 5 MR. LERNER: Yes. I said you're

 6 never going to talk about this outside the room.

 7 MR. MATTHEWS: Thank you, Doctor.

 8 BY MR. MATTHEWS:

 9 Q. Doctor, before we talk about

10 Sherr-Una Booker, I'd like to talk about your

11 experience and knowledge of IVC filters prior to the

12 implant in June of 2007, okay?

13 A. Okay.

14 Q. I know that's asking you to look

15 quite a bit back in the past. At the same time,

16 it's important that we explore what you knew and

17 when you knew it, okay?

18 Is it fair to say before you use any

19 medical device, the benefits have to outweigh the

20 risk of that device; is that a fair statement?

21 A. Yes.

22 Q. And that's how you practice medicine?

23 A. Yes.

24 Q. You look at benefits versus risks?

25 A. Yes.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 6 (18 - 21)

Page 21

 1 Q. You have to know the extent of the

 2 risks in order to make an assessment of whether that

 3 product, whether you're placing it in a person, is

 4 going to outweigh the risk, that is, the benefits

 5 outweigh the risks?

 6 MS. HELM: Object to the form.

 7 THE WITNESS: That is correct.

 8 BY MR. MATTHEWS:

 9 Q. If there are significant risks, you

10 need to give informed consent to your patients if

11 there's potential for a serious injury or death,

12 correct?

13 A. Yes.

14 Q. That type of information is crucial

15 for you, if there is a significant potential for

16 serious injury or death, to communicate to your

17 patient?

18 MS. HELM: Object to the form.

19 THE WITNESS: Yes.

20 BY MR. MATTHEWS:

21 Q. All right. Let me ask you about the

22 frequency of risk, and that is, the risk of serious

23 injury or death.

24 Is it important to you, as a treating

25 doctor that implants devices in a patient, what the

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 7 of 36
Page 22

 1 frequency of that risk is, whether it's one in a

 2 million or one in ten? Is that an important -- is

 3 that important information for you in determining

 4 the risk versus benefit analysis?

 5 A. Yes.

 6 MS. HELM: I need to object to the

 7 form.

 8 MR. LERNER: You need to let him

 9 finish his question before you give an answer.

10 THE WITNESS: My apologies.

11 MR. MATTHEWS: Do you need to take a

12 call?

13 THE WITNESS: Could I, please? I'm

14 so sorry. I'll be right with you.

15 MR. MATTHEWS: We'll take a break.

16 VIDEO TECHNICIAN: We are now off the

17 record. The time is 1:02.

18 - - -

19 (Whereupon, a brief recess was

20 taken.)

21 - - -

22 VIDEO TECHNICIAN: We are now back on

23 the record. The time is 1:06.

24 BY MR. MATTHEWS:

25 Q. Doctor, there was an objection. I

Page 23

 1 want to make clear the question to you.

 2 Is it important to you, as a

 3 clinician that implants medical devices, to know the

 4 frequency of which a device fails?

 5 A. Yes.

 6 MS. HELM: Objection to the form.

 7 BY MR. MATTHEWS:

 8 Q. It's important because you have to

 9 weigh that potential for failure and serious injury

10 with the benefit that the patient may have from the

11 product, correct?

12 MS. HELM: Object to the form.

13 THE WITNESS: Yes.

14 BY MR. MATTHEWS:

15 Q. All right. What about the risk of

16 serious injury, that is, the severity of the injury?

17 Is that also important for you to know, when doing a

18 risk/benefit analysis, whether you use a product or

19 not?

20 A. Yes.

21 Q. And those two individual points of

22 analysis, that is, frequency and severity of adverse

23 events, both of those are used in your prescribing

24 decisions?

25 MS. HELM: Object to the form.

Page 24

 1 THE WITNESS: Yes.

 2 BY MR. MATTHEWS:

 3 Q. Doctor, you only saw Ms. Booker in

 4 June of 2007; is that correct?

 5 A. Yes.

 6 Q. Prior to getting contacted about this

 7 case, for this case, you had no idea of the

 8 condition of her; is that true?

 9 A. Yes.

10 Q. You did not know that she had

11 multiple filter fractures and fragments that

12 embolized and traveled to her heart?

13 MS. HELM: Object to the form.

14 Mischaracterizes testimony.

15 MR. LERNER: And I don't -- when did

16 he have the knowledge -- I'm a little confused by

17 your question.

18 BY MR. MATTHEWS:

19 Q. Let me ask it this way: Prior to

20 today, have you had any information given to you

21 that she had fracture -- a fracture of that G2 that

22 embolized and traveled to her heart?

23 MS. HELM: Object to the form.

24 THE WITNESS: No.

25 BY MR. MATTHEWS:

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 7 (22 - 25)

Page 25

 1 Q. You've not heard that?

 2 A. No.

 3 Q. You had not heard she had open heart

 4 surgery?

 5 A. No.

 6 Q. Had you heard of other patients or

 7 read medical records of prior patients of yours that

 8 have had filter fractures?

 9 A. Yes.

10 Q. Have those patients suffered from

11 factors that have embolized to their heart?

12 A. Yes.

13 Q. Do they suffer from pericarditis when

14 this occurs? Have your prior patients suffered from

15 pericarditis?

16 A. No.

17 Q. Now, I want to be clear so the jury

18 understands.

19 The typical scenario when you're

20 contacted by, in this case Dr. Dean Martin, who is

21 an OB/GYN, who contacted you to consult with whether

22 Dean's patient -- Dr. Martin's patient needed a

23 filter or not. That is kind of the typical

24 scenario.

25 You're not treating the patient. You

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 8 of 36
Page 26

 1 don't own the patient, but you're consulting with a

 2 doctor who is treating the patient; is that a normal

 3 scenario?

 4 MS. HELM: Object to the form.

 5 THE WITNESS: Yes.

 6 BY MR. MATTHEWS:

 7 Q. So oftentimes, you'll treat a patient

 8 and implant a filter, as an example, or a stent, and

 9 that may be the only time that you see that patient?

10 A. Yes, but that's not the norm.

11 Q. It's not the norm.

12 That's what happened with Ms. Booker,

13 though, correct?

14 A. I'm not entirely sure. What I would

15 say, that is customary for me is to see a patient

16 before a procedure, make an assessment regarding

17 whether or not that procedure is necessary, and

18 that, as you alluded to, typically involves a

19 complex risk/benefit analysis.

20 And there are many factors that come

21 into play when we make those risk/benefit analyses,

22 and they include things like the natural history of

23 their disease process, their age, their

24 comorbidities and their life expectancy, the

25 proposed risks of whatever intervention we have or

Page 27

 1 are planning for them and so on.

 2 So my practice is such that I will

 3 see somebody before, make an assessment as to what

 4 is best, discuss treatment options with them, move

 5 forward if a procedure is required, and then see

 6 them, typically within a day afterwards to make sure

 7 that there were no complications as a result of our

 8 procedure.

 9 It's also customary for us to -- for

10 me, at least, to ask my patients to come back for

11 follow-up visits, at least one, within 30 days of

12 surgery or discharge from hospital.

13 Q. Okay. So to summarize, I think, what

14 you just said, you will typically see a patient

15 pre-operatively?

16 A. Correct.

17 Q. You will make a risk/benefit

18 analysis, you will perform the procedure, you will

19 see a patient post-op, and then you will want to see

20 that patient at least once within 30 days post-op?

21 A. Correct.

22 Q. Did I get that pretty much right?

23 A. Pretty much right.

24 Q. Okay. Now, oftentimes is it typical,

25 let me ask this, that after the 30 day follow-up you

Page 28

 1 will not treat that patient, in other words, that

 2 patient is being treated by someone else?

 3 A. Yes.

 4 Q. All right. And if there's a decision

 5 to remove a filter, that decision is often someone

 6 else's, whether it's a primary care physician,

 7 whether it's the orthopedic surgeon, whether it's

 8 the internist that's treating that patient, that

 9 decision oftentimes isn't even yours?

10 MS. HELM: Object to the form.

11 BY MR. MATTHEWS:

12 Q. Is that true? Is that basically

13 true?

14 MS. HELM: Same objection.

15 THE WITNESS: I'm not entirely sure

16 that I agree with that. I think we play an

17 important role in retrieving these filters, or at

18 least we try to.

19 So the whole issue of filter

20 retrieval is one that has been an evolution over the

21 years. And today it's part of our practice to

22 advise these patients to return for follow-up to

23 have filters retrieved, if it's possible to do so

24 and do so safely.

25 So a number of requirements must be

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 8 (26 - 29)

Page 29

 1 met for us to retrieve these filters.

 2 BY MR. MATTHEWS:

 3 Q. I'm going to back up, if I could,

 4 because now we're talking about 2017 --

 5 A. Correct.

 6 Q. -- and 2007 is the time frame. So

 7 I'm going to ask a different question.

 8 A. Okay.

 9 Q. Back in 2007 when you were implanting

10 in particular the G2, the G2 had only been cleared

11 for permanent implantation; is that correct?

12 A. Correct.

13 Q. So you were implanting this filter as

14 a permanent filter in 2007, correct?

15 A. Correct.

16 Q. At that time in 2007, that filter,

17 when you implanted it in Ms. Booker, was intended as

18 a permanent filter, correct?

19 MS. HELM: Object to the form.

20 THE WITNESS: Correct.

21 BY MR. MATTHEWS:

22 Q. All right. Well, let's talk about,

23 then, a different subject, and that is your history

24 with the use of filters.

25 Can you tell the jury when you first

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 9 of 36
Page 30

 1 started using inferior vena cava filters, IVC

 2 filters?

 3 A. Sure. During my vascular training.

 4 Q. What year was that?

 5 A. That would have been at the Mount

 6 Sinai Hospital in '97, '98.

 7 Q. Do you recall which filters you used

 8 at that time?

 9 A. Not particularly.

10 Q. Do you recall any of the filters you

11 used prior to the Bard G2?

12 A. Yes, I do.

13 Q. Could you tell us what you used?

14 A. Before using the Bard filter, we used

15 a filter by the Cordis Corporation, a division of

16 Johnson & Johnson, known as the TRAPEASE. We moved

17 away from using the TRAPEASE filter when it became

18 clear that it was associated with a high incidence

19 of caval thrombosis.

20 Q. Any other filters that you used?

21 A. I believe we transitioned away from

22 the Bard filter towards the Cook filter after it

23 became clear to us that there were certain problems

24 with the Bard filter as well.

25 I cannot specifically recall the

Page 31

 1 timelines as to when these things were done.

 2 Q. Did you ever use the Bard Recovery

 3 filter?

 4 A. I believe I did.

 5 Q. All right. So you used the Bard

 6 Recovery, the Bard G2, the Cordus TRAPEASE. And you

 7 said the Cook filters.

 8 Do you recall which Cook filters you

 9 used?

10 A. We use the Günther Tulip and right

11 now it's a variation of it called the Cook Celect,

12 C, as in Charles, E-L-E-C-T.

13 Q. You said you moved away from the Bard

14 filter because of problems associated with it,

15 correct?

16 A. Yes.

17 MS. HELM: Object to the form.

18 BY MR. MATTHEWS:

19 Q. What were the problems associated

20 with the Bard that -- the reason that you moved away

21 from it?

22 A. There is a database known as the

23 MAUDE database and it was becoming clear that there

24 were numerous reports in the literature of filter

25 fragmentation and filter migration with these

Page 32

 1 filters.

 2 Q. Do you recall the time frame when you

 3 moved away from Bard filters?

 4 A. I do not.

 5 Q. Clearly it was after 2007, because

 6 you were still implanting the G2 in 2007, correct?

 7 A. Correct.

 8 Q. Were you called upon by a sales rep

 9 or somebody that's known as a detailer from Bard

10 that came to your hospital to talk to you --

11 A. Yes.

12 Q. -- about their filters?

13 Do you recall that sales rep?

14 A. We had a number throughout the years

15 from different corporations, so if you could be a

16 little bit more specific.

17 Q. Well, I guess I'm referring to a

18 sales rep by the name of Ferrara.

19 Do you recall a sales rep by the name

20 of Ferrara?

21 A. Robert Ferrara?

22 Q. Ferrara, I'm sorry.

23 A. I do.

24 Q. Was he in your offices from time to

25 time to talk about the Recovery and the G2?

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 9 (30 - 33)

Page 33

 1 A. Uh-huh.

 2 Q. Yes?

 3 A. Yes.

 4 Q. I'm sorry. You've got to answer

 5 aloud for her.

 6 A. Yes.

 7 Q. Were you ever told by Mr. -- is it

 8 Ferrara?

 9 A. Uh-huh.

10 Q. -- Mr. Ferrara that Bard had a crisis

11 management plan, as early as 2004, to deal with the

12 high rates of AEs, that being, adverse events,

13 perforation, fracture and migration?

14 MS. HELM: Object to the form.

15 THE WITNESS: No.

16 BY MR. MATTHEWS:

17 Q. Were you ever told that Bard

18 conducted an investigation in 2004 into the high

19 number or large number of adverse events of the

20 Recovery done by an independent investigator?

21 MS. HELM: Object to the form.

22 THE WITNESS: No.

23 BY MR. MATTHEWS:

24 Q. Were you ever sent a letter by the

25 company that talked to you or -- I'm sorry, that

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 10 of 36
Page 34

 1 informed you about the results of this

 2 investigation, this independent investigation by

 3 Bard?

 4 MS. HELM: Object to the form.

 5 THE WITNESS: No.

 6 BY MR. MATTHEWS:

 7 Q. Were you ever told, either by letter

 8 or by Mr. Ferrara, that there was a 530 percent

 9 higher fracture rate than other filters on the

10 market with the Bard Recovery?

11 MS. HELM: Object to the form.

12 THE WITNESS: No.

13 BY MR. MATTHEWS:

14 Q. Were you ever told that there was a

15 1,200 percent higher risk of death from the Recovery

16 fracture and embolization to the heart than other

17 filters on the market?

18 MS. HELM: Object to the form.

19 THE WITNESS: No.

20 BY MR. MATTHEWS:

21 Q. In 2004 and 2005, clearly two years

22 prior to implanting Ms. Booker with the G2, would

23 that have been important information for you to

24 know? Assuming that that was information that was

25 known to Bard, is that something that you would want

Page 35

 1 to have known?

 2 A. Yes.

 3 MS. HELM: Object to the form.

 4 THE WITNESS: Can I interrupt for one

 5 second? I just wanted to clarify one other point.

 6 Previously you asked me how many

 7 publications I had regarding filters. And there's

 8 actually a third publication that I had forgotten,

 9 and I see it here in my C.V. It's one in which a

10 filter migrated to the heart. And with your

11 question before, I remember you asking me about

12 filters migrating to the heart.

13 BY MR. MATTHEWS:

14 Q. That was a case study, correct?

15 A. That was a case report, that's

16 correct.

17 Q. Yes, case report. I did read that.

18 Thank you.

19 MS. HELM: Do you mind telling us

20 which number that is?

21 THE WITNESS: That would be 28 to 32

22 under publications.

23 BY MR. MATTHEWS:

24 Q. Let me show you what's been marked as

25 Exhibit Number 2.

Page 36

 1 MS. HELM: Do you have a copy for me?

 2 MR. MATTHEWS: This is a health

 3 hazard evaluation dated December 17th, 2004.

 4 - - -

 5 (Whereupon, Exhibit-2,

 6 BPVE-01-01019821-825, Health Hazard Evaluation,

 7 Dated 12/17/04, was marked for identification.)

 8 - - -

 9 THE WITNESS: Thank you.

10 BY MR. MATTHEWS:

11 Q. Let me show you, if you could turn.

12 Just so we're clear on the record, this is a health

13 hazard evaluation from David Ciavarella, MD, who I

14 believe was the vice president of clinical trials --

15 clinical affairs, dated December 17th, 2004, to Doug

16 Uelmen, BPV QA. And this is Recovery Filter

17 Consultants Report, and I would turn your attention

18 to the second page --

19 A. Okay.

20 Q. -- under Number 2. It says that, The

21 consultant's analysis of the reports of Bard -- to

22 Bard of adverse events associated with the Recovery,

23 along with competitors' information available via

24 the MAUDE and IMS databases, showed the following:

25 Reports of death, filter migration, IVC perforation

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 10 (34 - 37)

Page 37

 1 and filter fracture associated with the Recovery

 2 filter were seen in the MAUDE database at reporting

 3 rates that were 4.6, 4.4, 4.1 and 5.3 higher,

 4 respectively, than reporting rates for all other

 5 filters.

 6 Doctor, this is dated December 17th,

 7 2004. Would this have been important information

 8 for you to know, that is, a doctor who is implanting

 9 Recovery filters, that those filters had a greater

10 risk of fracture that's four and five times higher

11 than the competitor filters?

12 MS. HELM: Object to the form.

13 THE WITNESS: Yes.

14 BY MR. MATTHEWS:

15 Q. Is that the type of information that

16 would influence your prescribing habits, whether you

17 would use that filter, a Bard filter, or another

18 filter?

19 MS. HELM: Object to the form.

20 THE WITNESS: Yes.

21 BY MR. MATTHEWS:

22 Q. Let me show you what's been marked as

23 Exhibit-3, which is the Recovery filter migration,

24 Remedial Action Plan, dated January 4, 2005.

25 - - -

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 11 of 36
Page 38

 1 (Whereupon, Exhibit-3,

 2 BPVE-01-01019773-784, Recovery Filter Migration,

 3 Dated 1/4/05, was marked for identification.)

 4 - - -

 5 BY MR. MATTHEWS:

 6 Q. Again, this is a full two and-a-half

 7 years prior to implanting Ms. Booker with the G2.

 8 And I would turn your attention to

 9 the first, second, third, fourth, fifth page. It

10 says, actually, 1 of 7 on the fifth page of that

11 document.

12 A. I'm sorry, could you --

13 Q. At the bottom under Roman III.

14 It says, Identification of the

15 problem: As part of the ongoing evaluation of RNF,

16 Recovery Nitinol filter, Bard requested an

17 independent study of the risks and benefits of the

18 RNF, with an emphasis on its use in bariatric

19 surgery and trauma patients. A consultant was

20 retained for this purpose and reported the

21 following: The MAUDE database maintained by the FDA

22 was reviewed. The reporting rates between the RNF

23 and aggregates of the other commercialized vena cava

24 filters were compared.

25 A, in the MAUDE dataset, the RNF

Page 39

 1 demonstrated a consistent statistically significant

 2 and potentially clinically important higher rate of

 3 reporting of adverse events in several analyzed

 4 categories.

 5 B, given the pattern of reported

 6 events, a higher rate of death reports seem related

 7 to filter movement and filter embolization.

 8 You referenced the MAUDE database

 9 earlier in questions, Doctor. Is that information

10 important to you as a doctor that is implanting the

11 Recovery filter?

12 MS. HELM: Object to the form.

13 MR. LERNER: Which information?

14 MR. MATTHEWS: That is A and B that I

15 just read.

16 MS. HELM: Object to the form.

17 MR. LERNER: But you questioned him,

18 you said you referenced the MAUDE database before.

19 Your question then becomes confusing. I'm asking

20 you to clarify it.

21 MR. MATTHEWS: All right. I'll

22 strike it and ask another question.

23 BY MR. MATTHEWS:

24 Q. In looking at A and B, Doctor, is

25 that the type of information that's important to you

Page 40

 1 to know prior to implanting a Recovery filter?

 2 A. Yes.

 3 MS. HELM: Object to the form.

 4 BY MR. MATTHEWS:

 5 Q. Do you know what the term

 6 "statistically significant" means?

 7 A. I do.

 8 Q. And that's an important

 9 epidemiological statement, correct?

10 MS. HELM: Object to the form.

11 THE WITNESS: Statistical statement,

12 yes.

13 BY MR. MATTHEWS:

14 Q. Doctor, at the Methodist Hospital in

15 2007, did you have more than one filter at your

16 disposal? That is, you talked about, I think you

17 told me, you had the TRAPEASE, you had the Tulip,

18 and you had the Recovery, and you had the select.

19 Were all of those available back in

20 2007, do you recall?

21 A. No.

22 Q. Do you know which were available?

23 A. The G2.

24 Q. That was the only one available in

25 the hospital?

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 11 (38 - 41)

Page 41

 1 A. It's very likely, although I could

 2 not say with certainty that a single filter would be

 3 stocked, yes.

 4 Q. You couldn't say that a single filter

 5 was used at the time; is that what your testimony

 6 is?

 7 A. My testimony is that it is common for

 8 us to, for certain periods, do business with a

 9 particular vendor and that vendor stock whichever

10 product we're using at the time, whether it be a

11 filter or a stent or something other.

12 It's possible that other devices were

13 in the hospital, but it's more likely that a single

14 product was being bought, stocked and used at the

15 hospital for IVC filters.

16 Q. Let me ask you this: As chief of

17 vascular surgery at Methodist Hospital, did you have

18 input on the formulary or -- in the formulary as to

19 which products would be stocked or which filters

20 would be used at the hospital?

21 A. Yes.

22 Q. So if you, the head of vascular

23 surgery said, you know, I don't want this filter but

24 I want these other two filters, or what have you,

25 you could have had an impact on that decision?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 12 of 36
Page 42

 1 A. I could have, yes.

 2 Q. Can you tell the jury about how many

 3 filters you would place annually starting in the

 4 early 2000s?

 5 And I admit that's a tough question,

 6 I know. But if you could give me a ballpark, let's

 7 say starting in 2005, two years prior to implanting

 8 Ms. Booker?

 9 A. I would have to go back and look at

10 those numbers, which I'm sure are available. But I

11 would say over 100 --

12 Q. You personally --

13 A. -- annually.

14 Q. -- or your department?

15 A. Our division, of which I do roughly

16 70 percent of the clinical volume. So a significant

17 number.

18 Q. Do you have a medical opinion on

19 which filter failure, if you will, was considered

20 the most serious --

21 MS. HELM: Object to the form.

22 BY MR. MATTHEWS:

23 Q. -- between filter failures, that is,

24 KILT, fracture, perforation, migration?

25 MR. LERNER: Are you talking -- what

Page 43

 1 time period are you talking about now?

 2 MR. MATTHEWS: Well, that was kind of

 3 a general question as to filters in general. So I

 4 will leave that open.

 5 BY MR. MATTHEWS:

 6 Q. Whether you have a medical opinion

 7 from your practice, from your reading, from your

 8 research, from your treatment of patients, as to

 9 which filter failure would be the most dangerous,

10 producing the most serious injury to a patient.

11 MS. HELM: Object to the form.

12 THE WITNESS: I do.

13 BY MR. MATTHEWS:

14 Q. What's your opinion?

15 A. Obviously, all complications are bad,

16 although caval thrombosis can be devastating in

17 terms of lower extremity edema and dysfunction. I

18 think that migration or fracture are more serious

19 events.

20 Q. Were you ever told, at any time prior

21 to today and being shown some documents about the

22 MAUDE database, that Bard evaluated specifically the

23 MAUDE database to compare their filter with others

24 in 2004?

25 MS. HELM: Object to the form.

Page 44

 1 THE WITNESS: No.

 2 BY MR. MATTHEWS:

 3 Q. Is that the type of information you

 4 would expect a manufacturer that sets out to make a

 5 decision, or at least look at the MAUDE information

 6 to determine filter fracture compared to other

 7 filters on the market, is that the type of

 8 information you want to know about?

 9 MS. HELM: Object to the form.

10 THE WITNESS: Yes. But it's a bit

11 more complicated in the sense that my understanding

12 of the MAUDE database is that it is a voluntary

13 database. It's not legally required for a physician

14 to report a problem with an implant or a product,

15 although you could argue that it is ethically

16 required. As with any database, it has problems

17 with regards to vetting of data, with regards to

18 accuracy of data.

19 So if a concern existed regarding a

20 particular product, yes, I think that should be

21 brought forth and studied, scientifically studied

22 and addressed.

23 BY MR. MATTHEWS:

24 Q. At a bare minimum, the MAUDE database

25 would be a signal, a red flag --

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 12 (42 - 45)

Page 45

 1 MS. HELM: Object to the form.

 2 BY MR. MATTHEWS:

 3 Q. -- a red flag that should cause and

 4 promote more research into whether a product is safe

 5 and effective?

 6 A. Agree.

 7 Q. Doctor, you obviously have read IFUs,

 8 instructions for use, in your practice?

 9 A. I have.

10 Q. I'm sure you probably have read more

11 than you care to talk about today, and I'm really

12 only going to talk about one.

13 A. Okay.

14 Q. In that regard, though, how many

15 products, medical devices, do you think that you

16 implant in your practice? And maybe I should just

17 talk about 2007 because that was the time frame in

18 which you implanted this filter.

19 In 2007, how many different medical

20 devices were you using in your practice to implant

21 in patients?

22 A. I'm trying to come up with some crude

23 numbers in my head to answer your question

24 accurately. I would say that it's exceedingly

25 common for us to use -- well, I would say that it

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 13 of 36
Page 46

 1 depends upon what you consider to be a product,

 2 right?

 3 If you're talking about sutures,

 4 well, obviously, that goes into everybody. If

 5 you're talking about implants, grafts, stents,

 6 filters, stent grafts, I would say it occupies a

 7 very prominent role in our practices today, as well

 8 as in 2007. I would estimate well over 50 percent

 9 of our cases requires some sort of implant, if not

10 75 percent. So a large number of our patients have

11 prosthetic implants, yes.

12 Q. So probably more than 50 different

13 products?

14 A. Yes, that's safe to say.

15 Q. To that extent, when you look at an

16 IFU, in part you rely on that because that comes

17 from the manufacturer and you expect that to include

18 the risks and benefits of the product; is that true?

19 MS. HELM: Object to the form.

20 You're leading, Dave.

21 MR. MATTHEWS: I am leading.

22 MS. HELM: Yeah, but you don't -- you

23 don't have him on cross.

24 MR. MATTHEWS: Well, we can talk

25 about that.

Page 47

 1 BY MR. MATTHEWS:

 2 Q. But let me ask you, then, this

 3 question, just so we're clear.

 4 Do you rely, in part, on IFUs, that

 5 is, instructions for use, with the products you

 6 implant in patients?

 7 A. Yes.

 8 Q. That would include --

 9 A. In part.

10 Q. That would include implants, grafts,

11 stents, filters and other permanent devices?

12 A. Yes.

13 MR. MATTHEWS: All right. I would

14 like to mark as Exhibit-4 an IFU from the G2 filter

15 system that, on the last page, is dated 10/06. And

16 I presume this was the effective IFU in place at the

17 time of implant in 2007.

18 - - -

19 (Whereupon, Exhibit-4, IFU, G2 Filter

20 System, was marked for identification.)

21 - - -

22 MR. LERNER: Just so we're clear,

23 that last thing was a statement, not a question,

24 correct?

25 MR. MATTHEWS: That was a statement.

Page 48

 1 I can't prove beyond the shadow of a

 2 doubt that there wasn't one after that, but I don't

 3 think there was.

 4 MR. LERNER: I wasn't arguing with

 5 you. I just wanted to make clear that that was a

 6 statement and not a question.

 7 MR. MATTHEWS: It was. And it will

 8 be stricken at the time of reading this deposition

 9 to a jury, I'm certain.

10 BY MR. MATTHEWS:

11 Q. Doctor, I'd like to -- I don't mean

12 to interrupt you, but I would like to ask a couple

13 of specific questions about this.

14 A. Please do.

15 Q. On the second -- on the right-hand

16 column, under 7, there is a -- under E, warning, G2

17 Filter implantation, it says, Filter fracture is a

18 known complication of vena cava filters.

19 Do you see that?

20 A. I do.

21 Q. It says, There have been -- There

22 have been reports of embolization of vena cava

23 filter fragments resulting in retrieval of the

24 fragment using endovascular and/or surgical

25 techniques. Most cases of filter fracture, however,

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 13 (46 - 49)

Page 49

 1 have been reported without any adverse clinical

 2 sequelae.

 3 I'd like to ask you about the first

 4 sentence: Filter fracture is a known complication

 5 of vena cava filters.

 6 Doctor, do you read that in the IFU

 7 to mean that the rates of filter fracture are

 8 similar with all filters?

 9 MS. HELM: Object to the form.

10 THE WITNESS: I don't read anything

11 about rate. I read something about complications

12 and about the potential for fracture. So it makes

13 no specific statements with regards to the incidence

14 of this occurrence.

15 BY MR. MATTHEWS:

16 Q. If there is evidence that the company

17 had, in 2006 or prior to that publication being sent

18 to you with the filter, and there was a showing

19 within the company of a 500 percent greater risk

20 with Bard filter compared with other filters, is

21 that the information -- the type of information that

22 you would want to know about?

23 MS. HELM: Object to the form.

24 THE WITNESS: Yes.

25 BY MR. MATTHEWS:

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 14 of 36
Page 50

 1 Q. Would you have informed your patient,

 2 based on your own ethics and your own consenting

 3 habits, would you have informed your patient about

 4 that, if it had said that in that IFU?

 5 MS. HELM: Object to the form.

 6 THE WITNESS: If I thought that a

 7 particular problem -- I'm sorry, a particular filter

 8 was a problem, was defective in some way, I unlikely

 9 would use that product.

10 BY MR. MATTHEWS:

11 Q. Do you expect medical device

12 manufacturers to monitor the safety of their devices

13 through appropriate testing before sale of the

14 product?

15 MS. HELM: Object to the form.

16 THE WITNESS: Yes.

17 BY MR. MATTHEWS:

18 Q. Do you expect medical device

19 companies to do and perform adequately powered

20 studies looking at the safety and the efficacy of a

21 product prior to its sale?

22 A. Yes.

23 Q. Do you expect a medical device

24 manufacturer to do proper postmarket surveillance of

25 that product once it gets on the market and sold

Page 51

 1 en masse, to follow that and inform doctors about

 2 what they see in the marketplace?

 3 A. Yes.

 4 Q. Were you ever told by Bard, Mr.

 5 Ferrara or anybody at Bard, that they had observed

 6 higher rates of complications with Recovery, that

 7 they placed it on a temporary commercial hold? Did

 8 you ever know that?

 9 MS. HELM: Object to the form.

10 THE WITNESS: No.

11 BY MR. MATTHEWS:

12 Q. Were you ever told why Bard withdrew

13 the Recovery from the market?

14 A. No.

15 Q. Were you ever told why Bard withdrew

16 G2 from the market?

17 A. No.

18 Q. Do you know Dr. Murray Ash?

19 A. No.

20 Q. Dr. Ash testified in this case that

21 he conducted a pilot study for the Recovery filter

22 and Bard advised him it would subsequently do a

23 larger safety study.

24 Let me ask you, do you know what a

25 pilot study is versus a clinical trial or --

Page 52

 1 A. I do --

 2 Q. -- clinical study?

 3 A. Yes.

 4 Q. When it wasn't done, it was never

 5 done, Dr. Ash testified that he had been misled by

 6 the company.

 7 Have you ever heard that about Dr.

 8 Ash and the Recovery filter?

 9 MS. HELM: Object to the form.

10 THE WITNESS: No.

11 BY MR. MATTHEWS:

12 Q. Doctor, have you ever reported a

13 filter failure to the FDA MAUDE database?

14 A. I have not.

15 Q. And, in fact, and you said this

16 earlier, one of the important aspects of the MAUDE

17 database, it's voluntary reporting system and the

18 only group, company or individual that has to

19 absolutely report is the manufacturer; you know

20 that, correct?

21 A. Yes.

22 Q. So the reporting system of doctors

23 like you who are very busy oftentimes don't report

24 to the MAUDE database filter failures --

25 A. Yes.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 14 (50 - 53)

Page 53

 1 Q. -- such as fracture?

 2 MS. HELM: Object to the form.

 3 THE WITNESS: Yes. But you have to

 4 understand that there's -- there's other reasons for

 5 that. I would just want to clarify by saying that

 6 these problems are not oftentimes seen immediately.

 7 So it takes some time for you to see a problem with

 8 regards to fracture and/or migration. So it is not

 9 uncommon for your patient to be seen or evaluated by

10 another physician in another hospital in another

11 location.

12 So the fact that I have not reported

13 any events to MAUDE implies that I have not seen any

14 immediate failures with the filters that I have used

15 in my practice, which is the case.

16 BY MR. MATTHEWS:

17 Q. If I understood what you just said,

18 that oftentimes the failure will happen down the --

19 down the line --

20 A. Correct, yes.

21 Q. -- and you won't know about the

22 failure?

23 A. Correct.

24 Q. Which is exactly like Ms. Booker, you

25 didn't know anything about her failure?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 15 of 36
Page 54

 1 A. That's exactly right.

 2 Q. And you have not undertaken to

 3 determine how many Recovery filters or G2 filters

 4 you have implanted; is that fair?

 5 A. That's very fair.

 6 Q. And you have not undertaken the task

 7 of determining what's happened with those patients

 8 into the future?

 9 A. Correct.

10 Q. You could never tell us, like, you

11 know, I implanted 100 and half of them or 80 percent

12 of them are great without problems, because you just

13 don't know?

14 A. That's right.

15 Q. Have you ever received a -- what's

16 called a Dear Doctor letter, sometimes called a Dear

17 Healthcare Provider letter, from Bard concerning its

18 Recovery or G2 filters?

19 A. Not that I recall.

20 Q. You know what that is, a Dear Doctor

21 letter, Dear Healthcare Provider letter, safety

22 alert?

23 A. I would make some assumptions, but

24 not truly.

25 Q. We talked about risk/benefit analysis

Page 55

 1 of using filters. I'd like to talk about the

 2 benefit or the efficacy, if I could, about filters;

 3 or, in other words, do they work.

 4 In 2012, you wrote a paper, I think

 5 it was called Concurrent Prophylactic Placement of

 6 IVC Filter in Bariatric Patients.

 7 Do you recall that?

 8 A. I do.

 9 Q. And you wrote that along with Dr.

10 Gorecki, Semaan, Briggs, Tortolani, correct?

11 A. Yes.

12 Q. Are they in your department?

13 A. Some of them, yes; some of them, no

14 longer.

15 Q. I'm going to mark this as Exhibit-5.

16 - - -

17 (Whereupon, Exhibit-5, Eastern

18 Vascular Society, Concurrent Prophylactic Placement

19 of Inferior Vena Cava Filter In Gastric Bypass and

20 Adjustable Banding Operations in the Bariatric

21 Outcomes Longitudinal Database, was marked for

22 identification.)

23 - - -

24 THE WITNESS: Thank you.

25 MS. HELM: Do you have a copy?

Page 56

 1 MS. BLAS: I do.

 2 BY MR. MATTHEWS:

 3 Q. And this is a paper you wrote along

 4 with these other doctors, correct?

 5 A. Yes.

 6 Q. All right. Have you seen this in a

 7 while?

 8 A. No, I haven't looked at it in quite

 9 some time.

10 Q. Well, this isn't a test. I just

11 wanted to ask a couple of questions about it.

12 A. Sure.

13 Q. Concurrent Prophylactic Placement

14 Inferior Vena Cava Filter in Gastric Bypass, what

15 we're talking about is during and after placement of

16 inferior vena cava with patients that have had lap

17 bands or band surgery, whether there was a benefit

18 with the use of a filter with those patients; is

19 that correct?

20 A. Yes.

21 Q. And you found in the conclusion, this

22 was actually presented in the Eastern Vascular

23 Society in DC in September of 2011, you found that

24 CPIVCF was associated with specific clinical

25 features, increased healthcare resource utilization

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 15 (54 - 57)

Page 57

 1 and higher mortality in patients undergoing

 2 bariatric operations. Although selected patient

 3 characteristics influenced surgeons to perform

 4 CPIVCF, this study was unable to establish an

 5 outcome benefit for CPIVCF.

 6 That was a mouthful.

 7 A. Yes.

 8 Q. But can you tell us what that means?

 9 A. What that means is that there appears

10 to be no benefit for morbidly obese patients

11 undergoing these procedures to undergo concurrent

12 placement of an IVC filter.

13 Q. So this filter in these -- in this

14 particular study was used prophylactically --

15 A. That is correct.

16 Q. -- to prevent PE post surgery from a

17 patient, correct?

18 A. Correct.

19 Q. And you found, with your other

20 authors, that there was no benefit of the filter?

21 A. Correct.

22 Q. That's an important finding.

23 Do you agree?

24 MS. HELM: Object to the form.

25 THE WITNESS: Yes.

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 16 of 36
Page 58

 1 BY MR. MATTHEWS:

 2 Q. Do you think it was a minor finding?

 3 MS. HELM: Same objection.

 4 THE WITNESS: No, I think that was an

 5 important finding and, hence, the reason why it was

 6 published in the medical literature.

 7 BY MR. MATTHEWS:

 8 Q. All right. There was a study in 1998

 9 by Dr. Decousus called the PREPIC 1 study.

10 Are you familiar with that study?

11 A. I am.

12 Q. When were you first familiar with the

13 study? When did you first see the study?

14 A. I don't know that I could answer that

15 accurately. I would assume in training or shortly

16 thereafter. The early years of clinical practice.

17 Q. There was a finding in that study --

18 and this was a randomized control trial --

19 A. Uh-huh.

20 Q. -- correct?

21 MS. HELM: Do you have a copy?

22 MS. BLAS: Yes.

23 THE WITNESS: Thank you.

24 - - -

25 (Whereupon, Exhibit-6, NEJM, A

Page 59

 1 Clinical Trial of Vena Caval Filters in the

 2 Prevention Of Pulmonary Embolism in Patients With

 3 Proximal Deep-Vein Thrombosis, was marked for

 4 identification.)

 5 - - -

 6 BY MR. MATTHEWS:

 7 Q. I would turn your attention to the

 8 second-to-the-last page, the bottom right-hand

 9 corner, last paragraph.

10 A. Second-to-last page?

11 Q. Yes. And the last full paragraph on

12 the bottom right-hand column.

13 This was a randomized control trial

14 that found, and I'm quoting this study, This study

15 demonstrated the initial efficacy of filters for the

16 prevention of pulmonary embolism in patients

17 presumed to be at high risk who had proximal deep

18 vein thrombosis and were receiving you

19 anticoagulants. However, because of the observed

20 excess rate of recurrent deep vein thrombosis and

21 the absence of any effect on mortality among

22 patients receiving filters, their systematic use

23 cannot be recommended in this population. In

24 addition, this study showed that

25 low-molecular-weight heparin was as effective and

Page 60

 1 safe as unfractionated heparin for the initial

 2 treatment of proximal deep vein thrombosis in

 3 patients presumed to be at high risk.

 4 Do you recall reading this -- about

 5 this study?

 6 A. I do.

 7 Q. Have you ever talked to Decousus or

 8 any of his co-authors from the thrombosis hospital

 9 in France?

10 A. I have not.

11 Q. Looking at this study, and there was

12 a follow-up, I think, eight years later, but strike

13 that --

14 A. There was.

15 Q. I'm sorry?

16 MR. LERNER: He said there was.

17 THE WITNESS: I said I'm familiar

18 with that.

19 BY MR. MATTHEWS:

20 Q. Are you familiar with the follow-up

21 study that, for all practical purposes, agreed with

22 the original study?

23 MS. HELM: Object to the form.

24 THE WITNESS: I am familiar with the

25 PREPIC 2 trial, yes.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 16 (58 - 61)

Page 61

 1 MS. HELM: I'm sorry, can the folks

 2 on the phone, can you please mute the phones? We're

 3 getting all kinds of noise.

 4 Thank you.

 5 BY MR. MATTHEWS:

 6 Q. Knowing about the lack of efficacy

 7 and the fact there was no reduction mortality in

 8 PREPIC 1 nor PREPIC 2, with the information I've

 9 shown you that there was a fivefold increased risk

10 for fracture with the G2, if you had known that

11 prior to implanting Ms. Booker in 2007, would you

12 have implanted that G2?

13 MS. HELM: Object to the form.

14 Mischaracterizes the prior testimony.

15 MR. LERNER: It's unclear, are you

16 talking about any filter or this particular filter?

17 MR. MATTHEWS: I was talking about

18 taking into account the lack of efficacy and the

19 fact there were no reduction in mortality in PREPIC

20 1 and PREPIC 2, coupled with the fact that the G2

21 had a fivefold increased risk for fracture compared

22 to other filters.

23 BY MR. MATTHEWS:

24 Q. In 2007 would you have implanted that

25 filter?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 17 of 36
Page 62

 1 MS. HELM: Object to the form.

 2 MR. LERNER: That particular filter?

 3 MR. MATTHEWS: That particular

 4 filter.

 5 THE WITNESS: The PREPIC 1 trial is a

 6 great study, and it's a very interesting study. But

 7 there are problems in this study, as there are

 8 problems with every study. And the fundamental

 9 problem that you have with this trial is that it

10 randomized patients who were candidates for caval

11 interruption or not; in other words, all patients

12 were treated with blood thinners. It doesn't really

13 address the question of what to do with those

14 patients that cannot be treated with blood thinners.

15 And from my review of the chart on

16 Ms. Booker, it was clear that she could not be

17 treated with blood thinners. The reason for that

18 was she had bleeding complications. She was, if I

19 recall, anemic, and she was to undergo subsequent

20 surgical interventions.

21 So her anticoagulation had to be

22 held, hence, PREPIC doesn't really apply to a

23 patient like Ms. Booker. It applies to a different

24 set of patients.

25 With regards to the Bard filter,

Page 63

 1 would I have used a different device if I knew at

 2 the time that the Bard filter was not ideal or as

 3 good as some of the other implants? The answer

 4 would have to be yes.

 5 BY MR. MATTHEWS:

 6 Q. You would have used --

 7 A. I would have used a different filter

 8 if there was a different filter that I knew of that

 9 was better, in terms of its safety profile.

10 Q. In terms of the documents that you

11 have, I think they are Exhibit-2 and 3, the health

12 hazard report and then the investigation conducted

13 by Bard that showed a fivefold increased risk for

14 fracture and embolization of that fracture, and you

15 told us that would be the type of information you

16 would want to know in your benefit/risk analysis,

17 knowing that --

18 A. Yes.

19 Q. -- and seeing that today, would that

20 have been enough to use another filter?

21 MS. HELM: Object to the form.

22 THE WITNESS: Difficult to say with

23 certainty. It would depend upon what other filters

24 we had at the time and what their problems would

25 have been. But it would have been a very important

Page 64

 1 piece of information, as far as making decisions

 2 regarding this or any other patient, yes.

 3 BY MR. MATTHEWS:

 4 Q. And it would have influenced your

 5 prescribing habit?

 6 MS. HELM: Object to the form.

 7 THE WITNESS: Yes.

 8 BY MR. MATTHEWS:

 9 Q. Let me show you a study, I'm going to

10 mark this as D'Ayala Exhibit Number 7. And this is

11 entitled, The Prevalence of Fracture -- I'm sorry,

12 let me hand that to you.

13 A. Sure.

14 Q. The Prevalence of Fracture and

15 Fragment Embolization of Bard Retrievable Vena Cava

16 Filters and Clinical Implications Including Cardiac

17 Perforation and Tamponade.

18 - - -

19 (Whereupon, Exhibit-7, AMA,

20 Prevalence of Fracture and Fragment Embolization of

21 Bard Retrievable Vena Cava Filters and Clinical

22 Implications Including Cardiac Perforation and

23 Tamponade, was marked for identification.)

24 - - -

25 BY MR. MATTHEWS:

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 17 (62 - 65)

Page 65

 1 Q. The first author in this study is

 2 William Nicholson.

 3 Do you see that?

 4 A. I do.

 5 Q. He is from Penn State, Hershey,

 6 Pennsylvania, as we see in the bottom left corner.

 7 A. Uh-huh.

 8 Q. Do you know Dr. Nicholson?

 9 A. I do not.

10 MR. LERNER: I apologize, is there a

11 date on this?

12 MR. MATTHEWS: Yes. This was

13 published in -- on August 9th, 2010.

14 MR. LERNER: Thank you.

15 BY MR. MATTHEWS:

16 Q. I'm sorry, did I ask you, have you

17 seen this study before?

18 A. I do not believe I have.

19 Q. Under the method, it says that these

20 doctors sought to determine the prevalence of

21 fracture and embolization of the Bard Recovery and

22 the Bard G2 vena cava filter.

23 That's the filter you implanted in

24 Ms. Booker, correct?

25 A. Correct.

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 18 of 36
Page 66

 1 Q. A retrospective single-center

 2 cross-sectional study was conducted by evaluating

 3 all patients who received either a Bard Recovery or

 4 Bard G2 filter from April 2004 until January 2009.

 5 Under the results it says, 13 of 80

 6 patients had at least one strut fracture. At least

 7 one strut in 7 of the 28 Bard Recovery filters

 8 fractured and embolized. In 5 of the 7 cases,

 9 patients had at least one fragment embolize to the

10 heart, 71 percent of those that fractured. Three

11 patients experienced life-threatening symptoms of

12 ventricular tachycardia and/or tamponade, including

13 one patient who experienced sudden death at home.

14 Six of 52 Bard G2 filters fractured, 12 percent. In

15 2 of these 6 cases, the patients had asymptomatic

16 end-organ fragment embolization.

17 Did I read that correctly?

18 A. Yes, sir.

19 Q. Okay. The conclusion of this study

20 by Dr. Nicholson and other doctors in different

21 fields of medicine found the Bard Recovery and Bard

22 G2 filters had high prevalence of fracture and

23 embolization with potentially life-threatening

24 sequelae.

25 Doctor, if you had been warned prior

Page 67

 1 to June of 2007 of this information, I know this is

 2 dated 2010, but I'm going to ask you the question

 3 for purposes of a hypothetical, that is, had you

 4 known this information of this conclusion, that the

 5 G2 had a high prevalence of fracture and

 6 embolization with life-threatening sequelae, would

 7 that have influenced your prescribing habits and the

 8 use of the G2 with Ms. Booker?

 9 MS. HELM: Object to the form.

10 THE WITNESS: Yes.

11 BY MR. MATTHEWS:

12 Q. Do you know of any reason back after

13 the pilot study in 2002 why Bard could not have

14 conducted a clinical trial with its G2 and done

15 follow-up with patients from the original pilot

16 study?

17 MR. LERNER: I'm not sure how --

18 MS. HELM: Object to form.

19 MR. LERNER: I'm not sure how he's

20 supposed to be able to answer a question like that.

21 That doesn't seem like a fair question for this

22 doctor.

23 MS. HELM: I object to the form.

24 BY MR. MATTHEWS:

25 Q. I ask you because you have conducted

Page 68

 1 studies. I ask you because you use these products.

 2 I ask you because you are a researcher to the extent

 3 that you have published studies specific to IVC

 4 filter.

 5 MR. MATTHEWS: I don't really think

 6 it's an unfair question.

 7 BY MR. MATTHEWS:

 8 Q. My question is, do you know of

 9 anything that would have presented Bard from

10 conducting the same type of study with the G2 prior

11 to the sale of the G2?

12 MS. HELM: Object to the form.

13 MR. LERNER: Again, I don't know how

14 he could answer. But if he can answer it, he can

15 answer it. I'm not going to fight with you about

16 it.

17 MR. MATTHEWS: If you're

18 uncomfortable with it, I'm going take it back.

19 MR. LERNER: I'm not here to argue

20 with you. I just don't think it's a fair question

21 for this doctor to answer what a corporation could

22 or couldn't do at a certain period of time.

23 MR. MATTHEWS: Well, all right, then,

24 I'll withdraw it.

25 MR. LERNER: Thank you.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 18 (66 - 69)

Page 69

 1 BY MR. MATTHEWS:

 2 Q. On the third page of this study, if

 3 you could turn to -- I'm sorry, I think I'd like to

 4 turn to the fourth page.

 5 A. Okay.

 6 Q. It says E4 on the bottom of it.

 7 A. Okay.

 8 Q. On the left-hand column, the first

 9 full paragraph. Left hand, first full.

10 A. I see it.

11 Q. It says, We would contend that the

12 fracture prevalence seen by Cantwell might have been

13 significantly higher if the filter was allowed to

14 remain in place for a longer period. If one were to

15 extrapolate our observed prevalence of Bard G2

16 filter fractures to 50 months, the prevalence of

17 fracture would be identical to that observed for the

18 Bard Recovery filter, thus challenging the

19 hypothesis that the Bard G2 filter represents an

20 improvement in fracture resistance.

21 The finding of the fracture rate of

22 the Recovery was 25 percent within this study; 25

23 percent of the filters fractured of the Bard

24 Recovery. These authors, after this study,

25 determined that the fracture rate would be the same

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 19 of 36
Page 70

 1 if you extrapolate indwelling time with the G2

 2 filter, that making it a 25 percent filter fracture

 3 rate for the G2.

 4 Do you understand that premise within

 5 the paper?

 6 A. I think I understand the premise.

 7 I'm not so sure that I understand the science behind

 8 it.

 9 Q. Well, let me ask you this question,

10 then, Doctor: If you knew back in 2007 when you

11 were implanting that filter that there was even a 12

12 percent probability of fracture with that filter,

13 would you have used a G2?

14 MS. HELM: Object to the form.

15 THE WITNESS: Unlikely.

16 BY MR. MATTHEWS:

17 Q. If there was a 25 percent risk of

18 filter fracture, can we safely say you would not

19 have used that filter?

20 A. Most likely. But you have to

21 understand that you have to have a way of treating

22 these difficult patients. So some filter has to be

23 used. And it becomes a matter of deciding which

24 filter is best, so to speak. And sometimes that's

25 not entirely clear.

Page 71

 1 MR. MATTHEWS: I'm going to object to

 2 the last part of that as nonresponsive.

 3 BY MR. MATTHEWS:

 4 Q. Doctor, I have pulled medical records

 5 from Methodist Hospital to try to pinpoint, so we

 6 don't have all of them, and I put them together and

 7 made them into an exhibit. And I'll mark it as

 8 Exhibit Number 8.

 9 - - -

10 (Whereupon, Exhibit-8,

11 BOOKERS_NYMH_MDR00057-461, Medical Records, was

12 marked for identification.)

13 - - -

14 BY MR. MATTHEWS:

15 Q. Just so we're clear, these are select

16 medical records that were pulled that I thought had

17 relevance, and I would like to ask you about some of

18 them.

19 A. Sure.

20 Q. Some of them have your name on them,

21 so I can't read them and I'm hoping you can read

22 your writing.

23 A. Let's try.

24 MS. HELM: For the record, these have

25 red boxes on them. Those red boxes were not part of

Page 72

 1 the original.

 2 MR. MATTHEWS: That's correct.

 3 They're not.

 4 MS. HELM: The red boxes were added

 5 by --

 6 MR. MATTHEWS: The red boxes were

 7 added by me for purposes of questioning the witness,

 8 and they can be taken out at the time of trial.

 9 MS. HELM: I'm just making sure the

10 record is clear --

11 MR. MATTHEWS: No, that's --

12 MS. HELM: -- the red boxes on

13 Exhibit-8 are not part of the original, they were

14 added by plaintiff's counsel.

15 MR. MATTHEWS: Exactly.

16 MR. LERNER: Can we go off the record

17 for just a second?

18 MR. MATTHEWS: Sure.

19 - - -

20 (Whereupon, a discussion off the

21 record occurred.)

22 - - -

23 VIDEO TECHNICIAN: We are now back on

24 the record. The time is 2:13.

25 BY MR. MATTHEWS:

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 19 (70 - 73)

Page 73

 1 Q. Doctor, let me show you what has been

 2 marked as Exhibit-11 to your deposition, which is an

 3 internal document from Bard.

 4 - - -

 5 (Whereupon, Exhibit-11,

 6 BPV-DEP-00004804-4806, 12/27/05 E-Mail from David

 7 Ciavarella to Brian Barry, was marked for

 8 identification.)

 9 - - -

10 MS. BLAS: I skipped 9.

11 MR. MATTHEWS: That's all right.

12 MS. HELM: It's 11 now.

13 BY MR. MATTHEWS:

14 Q. Doctor, have you had a chance to look

15 at that?

16 A. Uh-huh.

17 Q. I don't want to interrupt you, but --

18 A. Okay.

19 Q. First let me ask you, did you ever

20 use in your practice the Simon Nitinol filter,

21 referred here with an acronym SNF?

22 A. I have.

23 Q. And that is a filter, a permanent

24 filter that was in existence for many years prior to

25 the G2 being cleared by the FDA, correct?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 20 of 36
Page 74

 1 A. Correct.

 2 Q. There is a statement here in the

 3 middle, this is an internal document, I'll submit to

 4 you, it's an internal document between Bard

 5 personnel and the subject matter is the G2 Caudal

 6 migrations.

 7 In the middle of the page it says, I

 8 would like to look more generally at the G2

 9 complaints. I have seen problems with caudal

10 migration, tilting, perforation, mis-deployment and

11 maybe one or two additional things. Can you tell me

12 the total number of complaints and total number of

13 units distributed?

14 Then in the final line it says, The

15 G2 is a permanent filter. We also have one (the

16 SNF) that has virtually no complaints associated

17 with it. Why shouldn't doctors be using that one

18 rather than the G2? Can you also send me the total

19 complaint rate and MDR complaints of the SNF?

20 Do you know why -- strike that.

21 If the Simon Nitinol filter was

22 available in the hospital, knowing what you know of

23 the documents that I've shown you today, what this

24 company is saying internally to each other within

25 the company, would you have used the Simon Nitinol

Page 75

 1 filter instead of the G2 back in 2007 when you

 2 implanted Ms. Booker?

 3 MS. HELM: Object to the form.

 4 MR. LERNER: I'm going to ask you to

 5 rephrase that. You had a blip in the middle that

 6 made the question unclear.

 7 BY MR. MATTHEWS:

 8 Q. Knowing what you know today in

 9 viewing Exhibit-11, had you the choice in 2007,

10 would you have used the Simon Nitinol filter instead

11 of the G2?

12 MR. LERNER: When you say "the

13 choice," what do you mean by "the choice"?

14 MR. MATTHEWS: Would you have used it

15 instead?

16 MS. HELM: Object to the form.

17 MR. LERNER: Do you understand the

18 question?

19 THE WITNESS: I don't.

20 MR. LERNER: I don't, either.

21 BY MR. MATTHEWS:

22 Q. If you had the Simon Nitinol filter

23 available in 2007, knowing what you know today from

24 these documents that I've shown you, the studies

25 that I've shown you, and this internal document,

Page 76

 1 would you have used the Simon Nitinol instead of the

 2 G2 back in 2007?

 3 MS. HELM: Object to the form.

 4 MR. LERNER: So if he had that

 5 document in 2007, is that the preface of the

 6 question?

 7 MR. MATTHEWS: No. Had he known the

 8 information within that document, as well as the

 9 information of the other documents that I've shown

10 him today, would he use the Simon Nitinol filter?

11 MS. HELM: Object to the form.

12 THE WITNESS: When I look at this

13 document, Exhibit-11, that you gave me, all I see is

14 a group of individuals from a particular company

15 questioning a device, in particular its safety with

16 regards to what they're calling caudal migration.

17 It really makes no mention as to complication rates,

18 and the information that is asked for is not

19 included in this document.

20 So it would be difficult for me to

21 look at this document and say, boy, this is truly

22 incriminating, at least in my mind. I just look at

23 it as a series of questions between individuals

24 regarding a particular product and its safety.

25 I can make nothing of it. If I knew

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 20 (74 - 77)

Page 77

 1 that one filter was better than the other, as I said

 2 before, absolutely, I would use it. I mean,

 3 ultimately I don't work for industry, I work for my

 4 patients and their -- their interests are my

 5 interests.

 6 BY MR. MATTHEWS:

 7 Q. Do you know the material in the Simon

 8 Nitinol filter and how it's different from the G2?

 9 A. I'm not sure that the material would

10 be any different, in all honesty. I don't recall.

11 But if my memory serves me right, all these filters

12 were made out of nitinol, which is an alloy of

13 nickel, titanium and aluminum.

14 Q. Were the adverse events associated

15 with the nitinol filter or the G2 ever discussed

16 with you by any of the sales reps that called on

17 you?

18 MS. HELM: Object to the form.

19 THE WITNESS: No. No. But if you ask

20 me to speculate, I would think that it was more the

21 design and not the material of the filter that led

22 to some of these problems that we later saw with

23 fracture and migration.

24 BY MR. MATTHEWS:

25 Q. Have you --

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 21 of 36
Page 78

 1 MS. HELM: Excuse me, I have to move

 2 to strike the answer as nonresponsive.

 3 MR. MATTHEWS: Just object as

 4 nonresponsive and you're good.

 5 BY MR. MATTHEWS:

 6 Q. Have you looked at design documents

 7 or looked at design studies concerning the G2?

 8 A. No.

 9 Q. Where do you get the information that

10 you believe it is a design as opposed to a material

11 issue with the G2 fracturing?

12 MS. HELM: Object to the form.

13 THE WITNESS: If you were to look at

14 pictures of these two filters, they differ

15 substantially in terms of their design. The G2

16 filter has a conical design and the struts all come

17 together at a center point.

18 If I remember the Simon Nitinol

19 filter, it's sort of more of a mesh of constant

20 wire, which then attaches to an anchor. So it's a

21 very different design principle. And by virtue of

22 it being, I would suppose, more robust, I think the

23 likelihood of it embolizing is much lower.

24 BY MR. MATTHEWS:

25 Q. Did you ever have any centering --

Page 79

 1 A. But I don't know that to be a fact.

 2 That's not something that I particularly studied.

 3 I'm just making assumptions.

 4 Q. Fair enough. And I just want to know

 5 if there's something I needed to find out that you

 6 knew.

 7 But let me ask this: Did you ever

 8 have any centering issues with the G2?

 9 A. All filters have centering issues and

10 they, in part, depend on -- or are determined by the

11 patient's anatomy.

12 Q. Were there less centering issues with

13 the Simon Nitinol than there were with the conical

14 G2s?

15 MS. HELM: Object to the form.

16 BY MR. MATTHEWS:

17 Q. In your practice?

18 A. I would likely say yes.

19 Q. All right. If we could turn to the

20 first page that I see with your name on it.

21 A. Okay.

22 Q. Because I just want to put on the

23 record what you recognize as your own notes.

24 A. Okay.

25 Q. And I see that on the bottom

Page 80

 1 right-hand column, I'll read out the Bates stamp

 2 number, it's MBR93. And I'll tell you it's about

 3 the --

 4 MR. LERNER: The numbers on the

 5 bottom right-hand corner of the pages, the Bates

 6 stamp.

 7 MR. MATTHEWS: Yes. It's about the

 8 tenth page.

 9 MS. HELM: They're not in order.

10 MR. MATTHEWS: Like I say, I took

11 this many and tried to make it simple.

12 MS. HELM: So we're in Exhibit-8,

13 just for the record?

14 MR. LERNER: Can you hold it up and

15 show him the page? It might be quicker that way,

16 unless you have it already, Doctor.

17 MS. BLAS: It's Exhibit-8, yes.

18 THE WITNESS: I am. I'm at Page 63.

19 MS. HELM: 93.

20 MR. MATTHEWS: Let me do this for

21 you, Doctor, I'm going to make it easier. I'm going

22 to put little stickies on the pages, and that way --

23 BY MR. MATTHEWS:

24 Q. If we could turn to page Bates stamp

25 MDR93.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 21 (78 - 81)

Page 81

 1 Are you there?

 2 A. Uh-huh.

 3 MR. MATTHEWS: Is everybody there?

 4 BY MR. MATTHEWS:

 5 Q. There's some handwritten notes here.

 6 Are these yours?

 7 A. No.

 8 Q. Is the bottom right-hand corner

 9 yours?

10 A. No.

11 Q. If we could move to the next one,

12 which is MDR69.

13 A. Uh-huh.

14 Q. Any of those notes yours?

15 A. Yes, that's all written by me.

16 Q. Okay. It says, that I can read,

17 Preoperative diagnosis. It's the pre-op note. DVT

18 PE procedure planned, IVC filter. And then

19 pertinent medical history, physical finding.

20 A. Uh-huh.

21 Q. Can you read that?

22 A. It says, Patient with history of DVT

23 PE.

24 Q. And then to significant status

25 changes noted. And indication is what?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 22 of 36
Page 82

 1 A. Prevention of PE.

 2 Q. And then that's your signature?

 3 A. It is.

 4 Q. 6/21/07 at 7:30?

 5 A. Uh-huh.

 6 Q. All right. And the next entry that

 7 may or may not be yours, Page 71.

 8 A. No, that's -- that's mine.

 9 Q. It is? Okay.

10 A. Unmistakable.

11 Q. All right. I think that says,

12 37-year-old with history of DVT PE.

13 A. I'd be happy to translate into

14 English --

15 Q. Yes, please.

16 A. -- if you'd like.

17 6/21/07, vascular attending,

18 37-year-old with history of DVT PE.

19 Q. I'm sorry. On top of that, what does

20 that say? Does that say duplex?

21 A. I'm sorry, you're in the second box?

22 Yes, that says, Duplex chronic left superficial

23 femoral DVT.

24 Q. I apologize. Can we start over on

25 the first box?

Page 83

 1 A. The top box?

 2 Q. Yes, I messed up.

 3 A. Sure. 6/21/07, vascular attending,

 4 37-year-old with history of DVT PE. Uterine

 5 fibroids, vaginal bleed with DVT, despite

 6 anticoagulation. Awaiting surgical intervention.

 7 Q. Now, it says that, Agree with need

 8 for IVC filter.

 9 A. Uh-huh.

10 Q. And I believe you told us that that

11 was Dr. Martin with whom you were agreeing with; is

12 that right?

13 A. Yes. Well, to read that entire box

14 it says, 37-year-old awaiting GYN surgery with

15 chronic DVT and PE. Agree with need for IVC filter.

16 Will schedule for insertion of retrievable filter

17 today. Risk/benefits discussed with patient,

18 husband, who agreed to proceed.

19 Q. And when it says, Duplex showed

20 chronic superficial DVT, is that a duplex

21 ultrasound?

22 A. Correct.

23 Q. And that's done -- how is that done?

24 A. Using ultrasound.

25 Q. All right.

Page 84

 1 A. So the way duplex --

 2 Q. Externally --

 3 A. Correct, it's a non-invasive

 4 procedure.

 5 Q. Is that the gold standard for

 6 determining DVT, would you say?

 7 A. It depends upon the clinical

 8 scenario. But, yes, it's the imaging modality of

 9 choice for lower extremity DVT.

10 Q. If we turn to the next page, this

11 appears to be your op report, correct?

12 A. That is correct.

13 Q. Dated 6/21/07?

14 MS. HELM: For the record, can we

15 identify it by the Bates number, please?

16 MR. MATTHEWS: Yeah, Bates stamped

17 108 and 109. It's a two-page document.

18 MS. HELM: Thank you.

19 BY MR. MATTHEWS:

20 Q. I think this is all legible.

21 A. Indeed.

22 Q. There is a pre-operative diagnosis of

23 DVT and PE. Post-op diagnosis, insertion --

24 operation, insertion of retrievable IVC.

25 That actual -- is that actually

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 22 (82 - 85)

Page 85

 1 correct, that it was a retrievable IVC in 2007?

 2 A. I can tell you that we had retrieved

 3 a number of these G2 filters. I'm not so sure if

 4 the company had FDA approval for retrieval of that

 5 particular filter.

 6 By the IFU, it is incorrect.

 7 Q. All right. However, I think it was

 8 your testimony that this was implanted as a

 9 permanent filter?

10 MS. HELM: Object to the form.

11 THE WITNESS: It was.

12 BY MR. MATTHEWS:

13 Q. A few pages past that, MDR70, there

14 is another note that might be yours.

15 A. Uh-huh.

16 Q. And I believe this says, pre-op,

17 post-op diagnosis DVT PE procedure, IVC filter. No

18 venous anomalies, no caval thrombosis --

19 A. Uh-huh.

20 Q. -- patient's condition stable.

21 I can read that.

22 And then finally on MDR77, the last

23 one, I believe I saw with your name?

24 A. Uh-huh.

25 Q. Can you read that --

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 23 of 36
Page 86

 1 A. Sure.

 2 Q. -- for the record, please?

 3 A. 6/22/07, vascular attending. No

 4 complaints. Afebrile. Stable vitals. Groin with

 5 no hematoma. No complaints.

 6 My apologies. That says, Tolerating

 7 IVC filter well. Compression stockings.

 8 Q. So she went back on anticoagulation

 9 and stockings post implant?

10 A. The anticoagulation part, I'm not

11 sure about. The stockings, yes.

12 MR. MATTHEWS: I'll pass the witness.

13 MS. HELM: Do you mind if we take a

14 break? I think it will go a lot faster if we take a

15 break and you give me a few minutes to get

16 organized.

17 VIDEO TECHNICIAN: We are now off the

18 record. The time is 2:32.

19 - - -

20 (Whereupon, a brief recess was

21 taken.)

22 - - -

23 VIDEO TECHNICIAN: We are now back on

24 the record. The time is 2:44.

25 - - -

Page 87

 1 EXAMINATION

 2 - - -

 3 BY MS. HELM:

 4 Q. Doctor, my name is Kate Helm, and I

 5 represent CR Bard and Bard Peripheral Vascular in

 6 this lawsuit.

 7 We have not met before; is that

 8 right?

 9 A. That's correct.

10 Q. You mentioned that you had reviewed

11 records from Methodist Hospital and that you had

12 also reviewed records from Gwinnett Medical Center

13 in Georgia.

14 Those were provided to you by your

15 attorney; is that right?

16 A. Yes, ma'am.

17 Q. And do you know how he got them?

18 A. No.

19 Q. Have you had any conversations with

20 any attorneys representing Ms. Booker in this

21 lawsuit?

22 A. No. Other than today, no.

23 Q. And do you -- were you provided,

24 through your attorney, with any other documents

25 other than the Methodist records and the Gwinnett

Page 88

 1 Medical Center records?

 2 A. No.

 3 Q. I believe you mentioned previously

 4 that you also retrieve IVC filters; is that correct?

 5 A. I do.

 6 Q. And you also mentioned previously

 7 that you have retrieved the G2 filter; is that

 8 correct?

 9 A. I have.

10 Q. And do you also place filters that

11 are not retrievable filters? Do you also place

12 permanent filters?

13 A. No longer.

14 Q. When did you stop placing permanent

15 filters?

16 A. It would be difficult for me to say

17 with certainty. The practice of IVC filter use has

18 been an evolution over the last several years.

19 There's been a push away from using IVC filters in a

20 small measure based on studies like PREPIC, which

21 question the survival advantage associated with the

22 use of these filters.

23 Today, I would think, across the

24 country, far fewer filters are being placed. And

25 when they are placed, they are placed, more often

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 23 (86 - 89)

Page 89

 1 than not, for absolute indications as opposed to

 2 relative indications, which prompted their use in

 3 the past.

 4 Q. Did you ever place the Simon Nitinol

 5 filter?

 6 A. I did, yes.

 7 Q. I want you to go ahead -- let's go

 8 ahead and look at Exhibit-8, which is the records

 9 from Methodist Hospital.

10 A. Okay.

11 Q. And, specifically, Page 71, which is

12 one of your handwritten notes. It probably has a

13 sticker on it. It's immediately before the report.

14 MR. MATTHEWS: The third sticky.

15 MS. HELM: There you go.

16 THE WITNESS: Okay.

17 BY MS. HELM:

18 Q. In the bottom red box that was made

19 by the plaintiff's counsel, when you read your note

20 it says "retrievable" -- where it says -- the

21 sentence that says "retrievable," what does that

22 sentence say?

23 A. Scheduled for insertion of

24 retrievable filter today.

25 Q. And in 2007 when you were implanting

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 24 of 36
Page 90

 1 the filter in Ms. Booker, the G2 filter, you

 2 indicated in your note, in your handwritten note,

 3 that you were implanting it as a retrievable filter;

 4 is that right?

 5 A. Yes.

 6 Q. And on the next page, on Page 108,

 7 which is your op note, under the description of

 8 operation, it says, Insertion of retrievable IVC

 9 filter.

10 Is that right?

11 A. Uh-huh.

12 Q. And so, again, your operation was the

13 insertion of a retrievable IVC filter; is that

14 right?

15 A. Yes.

16 Q. And the filter that you chose for Ms.

17 Booker was a Bard G2 filter; is that right?

18 A. That's right.

19 Q. And you testified previously that you

20 have retrieved a number of Bard G2 filters?

21 A. I have.

22 Q. Okay. I think you -- it was

23 mentioned earlier that at the time you inserted the

24 Bard G2 filter in Ms. Booker, it had not been

25 cleared by the FDA for retrievability.

Page 91

 1 Were you aware of that?

 2 A. Yes.

 3 Q. But you were also aware that it was a

 4 filter that you were able to retrieve

 5 percutaneously; is that right?

 6 A. Yes.

 7 Q. You testified earlier that you

 8 implanted it as a permanent filter, yet your op

 9 notes and your handwritten notes clearly say that

10 you were inserting it as a retrievable filter.

11 So was it implanted as a retrievable

12 filter?

13 A. When --

14 MR. MATTHEWS: Object to the form.

15 THE WITNESS: When I stated that

16 earlier, that was based on my review of the medical

17 record. And my bias, I can tell you today, is to

18 use only retrievable filters and make every effort

19 at retrieving these filters, if possible. Even

20 permanent filters are potentially retrievable with

21 proper techniques, more often than not

22 percutaneously.

23 BY MS. HELM:

24 Q. Looking at the records from Methodist

25 Hospital and the history of Ms. Booker, and I'm

Page 92

 1 asking you to think back in time and I understand

 2 that, but based on what -- your review of your

 3 records and the history you had available to you, do

 4 you believe, and the language that you used in your

 5 op note and in your handwritten notes, you intended

 6 that this filter be retrieved when she was no longer

 7 contraindicated for anticoagulants; is that right?

 8 A. Yes, based on what I wrote there.

 9 MR. MATTHEWS: Object to the form.

10 BY MS. HELM:

11 Q. And I assume that you don't know

12 whether there was any discussion with Ms. Booker or

13 any of her healthcare providers, after you implanted

14 the filter, as to whether it could or should be

15 retrieved; is that right?

16 A. I can tell you that if I intended it

17 to be a retrievable implant, that conversation would

18 have taken place with Ms. Booker.

19 Q. And based on your notes that you

20 discussed the risks and benefits -- again, I'm back

21 on 71 -- with Ms. Booker and that you were

22 scheduling her for a retrievable filter, is it your

23 testimony that it would have been your practice to

24 discuss with her the fact that the filter was

25 retrievable and should be retrieved when she was no

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 24 (90 - 93)

Page 93

 1 longer contraindicated for anticoagulants?

 2 MR. MATTHEWS: Object to the form.

 3 THE WITNESS: Yes.

 4 BY MS. HELM:

 5 Q. And as you sit here today, you don't

 6 know why her filter wasn't retrieved before 2014, do

 7 you?

 8 A. I can only guess.

 9 Q. We're not asking you to guess.

10 In 2007 when you implanted Ms.

11 Booker's G2 filter, you were aware of the potential

12 complications associated with that filter, were you

13 not?

14 MR. MATTHEWS: Object to the form.

15 THE WITNESS: Of the G2 filter?

16 BY MS. HELM:

17 Q. Yes.

18 A. The reported complications at the

19 time I was aware of, I'm sure.

20 Q. And, in fact, you previously looked

21 at Exhibit-4, which was the IFU --

22 A. Yes.

23 Q. -- for the G2 filter.

24 And you would have had that IFU

25 available to you before you implanted Ms. Booker's

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 25 of 36
Page 94

 1 filter, correct?

 2 A. Yes.

 3 Q. And, specifically, in Section G of

 4 the IFU, it discusses that one of the known

 5 complications of the G2 filter is movement or

 6 migration; is that right?

 7 A. It does.

 8 Q. And it also specifically addresses

 9 that filter fracture is a known complication of vena

10 cava filters, does it not?

11 A. It does.

12 Q. And, in fact, fracture is a

13 complication of all vena cava filters, isn't it?

14 A. It is. As is migration.

15 Q. Thank you.

16 And the G2 -- and the IFU for the G2

17 filter that you implanted in Ms. Booker specifically

18 says that, There have been reports of embolization

19 of vena cava filter fragments resulting in retrieval

20 of the fragment using endovascular and/or surgical

21 techniques. Most cases a filter fracture, however,

22 have been reported without any adverse clinical

23 sequelae.

24 Is that right?

25 A. Uh-huh.

Page 95

 1 Q. And so before treating Ms. Booker in

 2 2007, you were aware, as you've stated, that filter

 3 fracture was a risk associated with a G2 and all

 4 filters; is that right?

 5 A. Yes.

 6 Q. And you took that into consideration

 7 when weighing the risk/benefit for implanting a G2

 8 filter in Ms. Booker; is that right?

 9 A. Yes.

10 Q. You testified earlier that Ms.

11 Booker, because of what was going on in her medical

12 condition, was contraindicated for anticoagulants at

13 the time you inserted the filter, correct?

14 A. Yes.

15 Q. But she had a history of both PE and

16 DVT, correct?

17 A. Correct.

18 Q. And she was about to undergo surgery

19 for a cervical mass; is that right?

20 A. Right.

21 Q. And so she had to be removed from the

22 anticoagulant medication?

23 A. Right.

24 Q. But it was your -- was it your

25 understanding that post surgery that medication

Page 96

 1 would be resumed, or did you have an understanding

 2 of that?

 3 A. I'm not entirely sure that that is

 4 clear to me from the record. I can tell you that it

 5 would be my practice to discuss resumption of

 6 anticoagulation with all of the physicians involved

 7 in her care.

 8 In this particular case, it would

 9 depend on no small measure as to the comfort level

10 regarding her potential for rebleeding. Keep in

11 mind, she came in anemic with a vaginal bleed and

12 she came in with DVTs and a pulmonary embolism

13 despite anticoagulation.

14 Q. Back on Page -- and I apologize, I'm

15 jumping around -- but back on Page 71 --

16 A. Sure.

17 Q. -- in your handwritten note it says,

18 Risk/benefits discussed with patient.

19 Is that right? I hope that's what it

20 says.

21 A. Yes.

22 Q. Schedule for insertion --

23 A. Yes.

24 Q. -- of retrievable filter today?

25 A. Yes. Risks/benefits discussed with

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 25 (94 - 97)

Page 97

 1 patient, husband, who agreed to proceed.

 2 Q. And what was your practice at the

 3 time, do you recall -- at the time in 2007, what

 4 risk/benefits would you have discussed with Ms.

 5 Booker relating to the insertion of the retrievable

 6 filter?

 7 A. Right. What I would discuss with any

 8 young patient regarding any implant is concerns

 9 regarding durability, procedural complications. I

10 would discuss the potential for bleeding, infection;

11 a dye reaction, very unlikely, some degree of renal

12 insufficiency as the complication of the use of dye.

13 And as far as long-term

14 complications, as I stated, durability and the

15 potential for caval thrombosis, migration,

16 fragmentation. Hence, the importance for follow-up

17 and attempt at retrieval in the future.

18 Q. Was it your practice in 2007, at the

19 time you treated Ms. Booker, to inform patients that

20 the filter might have to be left permanently or --

21 A. Yes.

22 Q. -- might be there permanently?

23 And because you had identified it as

24 a retrievable filter, would you have discussed with

25 her how the retrieval of the filter would be

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 26 of 36
Page 98

 1 accomplished, if that was to be done?

 2 MR. MATTHEWS: Object to the form.

 3 THE WITNESS: Usually, we would tell

 4 them that that would be a percutaneous procedure,

 5 similar to the insertion procedure, although

 6 sometimes not possible.

 7 BY MS. HELM:

 8 Q. Did you -- was it your practice in

 9 2007 to provide the plaintiff or her family member

10 with any written materials about the filter or the

11 procedure?

12 A. No.

13 Q. And would you ever give a patient a

14 copy of the IFU?

15 A. No.

16 Q. Why not?

17 A. I've never done so. It's just not my

18 practice to do so. I think that as a physician when

19 you're dealing with a patient, it's really on you to

20 make some important decisions for them. And I think

21 an IFU is a complicated document. You may correct

22 me if I'm wrong, but I think the IFU is mostly

23 intended for legal purposes. I'm not so sure it's

24 intended to guide medical practice. And I don't

25 think its intent is in any way to guide a patient in

Page 99

 1 their decision-making process.

 2 Q. And I know you have no recollection

 3 of Ms. Booker and --

 4 A. No.

 5 Q. -- no one is questioning that.

 6 But your notes don't indicate that

 7 she had any specific questions or concerns, do they?

 8 A. No.

 9 Q. Based on your op note and looking

10 back at what you can recreate using it, did you feel

11 like this was a successful implantation of a G2

12 filter?

13 A. Yes.

14 Q. It appears to be uncomplicated; is

15 that right?

16 A. Yes.

17 Q. And she seemed to have tolerated it

18 well?

19 A. Yes.

20 Q. And there were no post implant

21 complications?

22 A. Nope.

23 Q. As far as you were --

24 A. As far as I know.

25 Q. Okay. Based on your review of the

Page 100

 1 medical records, did you see, treat Ms. Booker after

 2 the implantation of the filter?

 3 A. No. I saw her the day afterwards,

 4 based on these records, which, as we discussed

 5 previously, is customary.

 6 I have no personal office records of

 7 Ms. Booker ever seeing me after hospital discharge.

 8 Q. Would it have -- was it your practice

 9 in 2007 to recommend that a patient come back and

10 see you at least once after discharge?

11 A. Yes.

12 Q. But as far as your records indicate,

13 Ms. Booker never did that?

14 A. Yes.

15 Q. Doctor, at the beginning of the

16 deposition you were shown a handful of internal

17 documents from Bard, specifically you were shown two

18 Bard internal documents and an e-mail.

19 Do you recall those?

20 A. I do.

21 Q. Have you ever been shown internal

22 documents from any other device manufacturer?

23 A. No.

24 Q. Have you ever requested internal

25 documents from a device manufacturer in performing a

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 26 (98 - 101)

Page 101

 1 risk/benefit analysis --

 2 A. No.

 3 Q. -- of a product?

 4 Do you know -- was today the first

 5 time you had ever seen Exhibits-2 and 3?

 6 A. Yes.

 7 Q. And you did not have the opportunity

 8 to read those exhibits in their entirety, did you?

 9 A. No.

10 Q. But both of the exhibits on their

11 face indicate that they are about the Recovery

12 filter, do they not?

13 A. Indeed.

14 Q. And, in fact, the filter that you

15 implanted in Ms. Booker was not a Bard Recovery

16 filter, was it?

17 A. That is correct.

18 Q. It was a Bard G2 filter, correct?

19 A. Yes.

20 Q. And do you -- are you aware of what

21 action Bard took as a result of its evaluation of

22 the Recovery filter?

23 A. No.

24 Q. And it looks like Bard was doing an

25 internal analyzation of its Recovery filter,

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 27 of 36
Page 102

 1 correct?

 2 A. It does.

 3 Q. And you don't know what Bard did in

 4 response to this internal evaluation; is that right?

 5 A. I do not.

 6 Q. And you don't know what changes Bard

 7 made between the Recovery filter and the G2 filter,

 8 do you?

 9 A. No.

10 Q. I have to ask you very briefly about

11 Exhibit Number 11.

12 You don't have the context of this

13 e-mail, do you?

14 A. I have no idea.

15 Q. And you don't know what -- how it's

16 been explained by company witnesses or anything like

17 that, do you?

18 A. I do not.

19 Q. So there's no way for this internal

20 e-mail to -- taken out of context to have any impact

21 on your prescribing decisions in making a

22 determination about a filter, does it?

23 A. No. I think I made that clear

24 previously. To me, it seems like a proper

25 discussion amongst company officials regarding

Page 103

 1 concerns that are arising regarding a particular

 2 product.

 3 Q. Fair.

 4 Are you aware that in this litigation

 5 that Bard has produced over two million pages of

 6 documents?

 7 A. No.

 8 Q. And Mr. Matthews showed you just a

 9 handful of pages, didn't he?

10 A. Uh-huh.

11 Q. And you don't know what the

12 explanation is, what the outcome is, what the

13 context is of any of these documents, do you?

14 A. No.

15 Q. And when he asked you previously, if

16 you had known certain information would you have

17 made a different decision, you don't know whether

18 the information he was providing to you was accurate

19 or not, do you?

20 A. I do not.

21 Q. So when he was telling you, for

22 example, that the G2 had a five times risk rate for

23 fracture compared to other filters, you don't know

24 if that's accurate or not, do you?

25 A. I have not seen the data that would

Page 104

 1 substantiate that claim; no, I have not.

 2 Q. Have you ever been provided with

 3 comparative rate data from manufacturers regarding

 4 any product that you use, any medical device that

 5 you use?

 6 A. Not to my knowledge.

 7 Q. Have you ever asked for comparative

 8 rate data on any product or medical device that you

 9 implant from any manufacturer?

10 MS. HELM: Do you need to take that?

11 THE WITNESS: Could you excuse me for

12 just a moment, please? Thank you.

13 MS. HELM: Sure. We'll go off the

14 record.

15 VIDEO TECHNICIAN: We are now off the

16 record. The time is 3:05.

17 - - -

18 (Whereupon, a brief recess was

19 taken.)

20 - - -

21 VIDEO TECHNICIAN: We are now back on

22 the record. The time is 3:08.

23 BY MS. HELM:

24 Q. Doctor, I was talking to you about

25 Exhibits-2, 3 and 11, but particularly 2 and 3.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 27 (102 - 105)

Page 105

 1 And I assume that you're also not

 2 aware that a number of Bard witnesses and employees

 3 have had their depositions taken --

 4 A. I am not.

 5 Q. -- about these documents and the

 6 actions and information in these documents?

 7 You're not aware of that, are you?

 8 A. No.

 9 Q. And plaintiff's counsel didn't show

10 you any of that testimony, did he?

11 A. No.

12 Q. When it comes to making decisions for

13 your patients and weighing the risk and benefits of

14 medical devices that you use with your patients, you

15 rely on a number of sources, don't you?

16 A. I do.

17 Q. You rely on the FDA?

18 A. Yes.

19 Q. You rely on your partners and

20 colleagues?

21 A. Yes.

22 Q. You rely on available medical

23 literature regarding the device or the product?

24 A. Yes.

25 Q. You rely on your own experiences?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 28 of 36
Page 106

 1 A. I do.

 2 Q. And you work with a number of

 3 different medical devices, I think you said as many

 4 as 50; is that right?

 5 A. Off the top of my head I would say

 6 yes.

 7 Q. And what you rely on is the

 8 manufacturer of medical devices to provide you with

 9 reliable information about the device; is that fair?

10 A. Yes.

11 Q. And you would not want to receive

12 unreliable or preliminary or internal investigations

13 without knowing the outcome or the results; is that

14 right?

15 A. That's right.

16 Q. Because getting unreliable or

17 incomplete information could harm your patient care,

18 couldn't it?

19 A. It could be misleading, yes.

20 Q. And it could negatively impact your

21 practice, couldn't it?

22 A. Yes.

23 Q. So in making treatment decisions for

24 patients, you are not -- you don't rely on

25 information contained in internal documents from the

Page 107

 1 medical -- let me start that over. I got lost in my

 2 own question.

 3 In making treatment decisions for

 4 your patients, you're not relying on information

 5 contained in internal documents from manufacturers

 6 of medical devices, are you?

 7 A. No.

 8 Q. It has been suggested to you today

 9 that Bard Recovery and G2 filters have complication

10 rates that are significantly higher than other

11 filters.

12 Do you recall that being suggested to

13 you?

14 A. Yes.

15 Q. In your own experience, did the G2

16 filter have an unexpectedly high complication rate

17 over other filters?

18 A. In the short-term, no; in the

19 long-term, I think it is well recognized that those

20 filters are associated with a high incidence of

21 fracture and fragment migration. Based on my

22 experience, I have not seen a lot of filters

23 fragment or migrate.

24 Q. In fact, in one of the articles you

25 wrote in 2012 -- was it this one or the other one --

Page 108

 1 you stated that complications from filters -- let me

 2 make sure I find your language.

 3 IVC filter placement is generally

 4 considered to be a benign procedure with a low

 5 complication rate.

 6 Is that right?

 7 A. That is right.

 8 Q. And then you said, Its association

 9 with significant cost and long-term complications is

10 being increasingly recognized.

11 Right?

12 A. Yes, ma'am.

13 Q. And, in fact, that's why you

14 recommend to patients that you follow-up and that

15 they have their filters retrieved when they're no

16 longer needed, correct?

17 A. Yes.

18 Q. Have you ever seen any peer-reviewed

19 literature saying that the G2 filter has

20 complication rates that are significantly higher

21 than other filters?

22 A. No.

23 Q. So sitting here today, you're not

24 aware of any medical literature that shows that the

25 complication rates for the G2 filter are higher than

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 28 (106 - 109)

Page 109

 1 any other filters that were available; is that

 2 right?

 3 A. I would rephrase that by saying I

 4 have not seen any literature that directly compares

 5 the G2 filter to any other filter and states that

 6 that filter is more dangerous or less efficacious.

 7 Q. Thank you.

 8 Have you ever seen any FDA

 9 denouncement saying the G2 filter has complication

10 rates that are significantly higher than other

11 filters?

12 A. I have not.

13 Q. When we talked about Exhibits-2 and

14 3, you indicated that it appeared that Bard was

15 doing some internal investigation of the Recovery

16 filter; is that right?

17 A. Yes.

18 Q. And do you -- in the case of this

19 internal assessment, do you know anything beyond

20 what you were able to briefly look at today?

21 A. No.

22 Q. So you don't know how Bard -- what

23 conclusions Bard reached or what actions Bard took;

24 is that right?

25 A. That's right.

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 29 of 36
Page 110

 1 Q. And you don't know whether the FDA

 2 was fully satisfied with information it received

 3 from Bard and with its continuing to market the

 4 Recovery filter despite analysis of complications;

 5 is that right?

 6 A. That's right.

 7 Q. And you were asked if you knew why

 8 the Recovery filter was taken off the market.

 9 Do you recall that question?

10 A. Yes.

11 Q. And do you understand that the G2

12 filter is a second generation?

13 A. I do.

14 Q. And, in fact, it replaced the

15 Recovery filter?

16 A. Indeed.

17 Q. So does it make sense to you that

18 when they put the G2 on the market they took the

19 Recovery off the market?

20 A. Yes.

21 Q. And are you aware that there was a

22 filter that replaced the G2?

23 A. I've since stopped using the Bard

24 filters, so I'm not familiar with that particular

25 product.

Page 111

 1 Q. Did you ever use the Bard Eclipse

 2 filters?

 3 A. I couldn't say. Perhaps.

 4 Q. Do you recall when you stopped using

 5 Bard filters?

 6 A. No.

 7 Q. But if the Eclipse filter was a later

 8 generation of the G2, would it make sense to you

 9 that Bard took the G2 off the market when it brought

10 the Eclipse to market?

11 A. Sure.

12 Q. That's something that medical device

13 manufacturers do all the time, right?

14 A. Indeed, improve their products, sure.

15 Q. And you would expect them to,

16 correct?

17 A. I would hope so.

18 Q. You would expect them to be looking

19 at reports of adverse events from the -- from

20 patients and analyzing their filters and

21 continuously looking to improve the product; is that

22 right?

23 A. Yes.

24 Q. And you would agree with me that

25 that's part of the risk/benefit analysis that a

Page 112

 1 manufacturer should do before bringing a product to

 2 market, correct?

 3 A. Yes.

 4 Q. You would also agree with me that

 5 within -- with any medical device there are risks?

 6 A. Absolutely.

 7 Q. And with any medical device there are

 8 risks that are -- that are going to be -- that

 9 are -- let me not get caught in my own question

10 again -- there are risks that may come to light

11 after the product is on the market?

12 A. Yes.

13 Q. And the manufacturer's responsibility

14 in that instance is to evaluate those risks and

15 evaluate the product, correct?

16 A. Yes.

17 Q. And to warn about the risks; is that

18 right?

19 A. Yes.

20 Q. You were asked previously about

21 whether you ever received a Dear Doctor or Dear

22 Colleague letter from Bard relating to the Recovery

23 filter.

24 Do you recall those questions?

25 A. I do.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 29 (110 - 113)

Page 113

 1 Q. If Bard's database indicates that a

 2 Dear Doctor letter that went out in December 2004

 3 relating to the Recovery filter was sent to you and

 4 to Methodist Hospital, you don't have any reason to

 5 dispute that, do you?

 6 MR. MATTHEWS: Object to the form.

 7 THE WITNESS: I do not.

 8 BY MS. HELM:

 9 Q. You just simply don't recall

10 receiving it?

11 A. That's exactly right. I simply don't

12 recall receiving it. As you can imagine, I receive

13 a lot of letters, a lot of documents, a lot of

14 e-mails, a good number of which go unread.

15 Q. You made a comment earlier about that

16 it was your -- and I can't remember what word you

17 used, but you said that you thought that maybe it

18 was the design of the G2 or the Recovery filter that

19 was different than the SNF that caused it to have

20 different adverse events once it was implanted.

21 Do you remember that?

22 A. Uh-huh, I do.

23 Q. Is that speculation on your part?

24 A. Yes.

25 Q. And just to make sure, you have never

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 30 of 36
Page 114

 1 designed --

 2 A. No.

 3 Q. -- an IVC filter, correct?

 4 A. No.

 5 Q. And you've never built one?

 6 A. I just do my best to put them in.

 7 Q. Thank you.

 8 Do you recall any specific

 9 discussions you had with the sales reps from Bard

10 regarding the G2 filter?

11 A. No.

12 Q. Do you recall ever raising any

13 questions or concerns with the sales reps regarding

14 the G2 filter?

15 A. No.

16 Q. Your decision to stop using Bard

17 filters was based on your review of literature; is

18 that right?

19 A. It would be based on multiple --

20 multiple factors. As I told you before, my personal

21 experience was that initially the complication rate

22 was low and acceptable. But long-term durability of

23 these implants became clear based on reports

24 published in the literature, based on discussions

25 with colleagues.

Page 115

 1 Q. I want to circle back around, and

 2 specifically relating to Exhibit-2.

 3 Do you know if medical device

 4 manufacturers -- and Exhibit-2, we're talking about

 5 frequency of adverse events, comparing the Recovery

 6 filter to other filters.

 7 Do you know if medical device

 8 manufacturers are even permitted to provide doctors

 9 with alleged complication rates, comparative

10 complication rates under the FDA guidelines?

11 A. I do not.

12 Q. And that's not something anyone has

13 ever provided to you, though, is it?

14 A. No, it is not.

15 Q. No sales rep has ever come in and

16 said, look at us compared o your competitor; is that

17 right?

18 A. That is incorrect. Most sales reps

19 will come in with the intent of selling a product,

20 so they will say, look at us compared to our

21 competitor. But, of course, in a more favorable

22 light.

23 Q. Have they ever shown you alleged

24 complication rates comparing the two products?

25 A. Which two products?

Page 116

 1 Q. A Bard filter and another filter.

 2 A. I have not seen that, no.

 3 Q. Based on this, you know, the limited

 4 time you've had with Exhibit-2 and Exhibit-3, do you

 5 have any reason to believe that Bard wasn't actively

 6 investigating the incidents at the time it wrote

 7 these documents in 2004 and January of 2005?

 8 MR. MATTHEWS: Object to the form.

 9 THE WITNESS: No.

10 BY MS. HELM:

11 Q. You were shown a study by Dr.

12 Nicholson, it's Exhibit-7.

13 And, again, you were not familiar

14 with this study; is that right?

15 A. I think it's fair to say that that is

16 correct.

17 Q. And when you implanted the G2 filter

18 as a retrievable filter in Ms. Booker in 2007, this

19 information from 2010 obviously wasn't available to

20 you; is that fair?

21 A. Yes.

22 Q. Doctor, are you aware that in this

23 litigation Dr. Nicholson and his research

24 coordinator have had their depositions taken?

25 A. No.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 30 (114 - 117)

Page 117

 1 Q. Are you aware that he has produced

 2 his study documents in this litigation?

 3 A. No.

 4 Q. If the testimony of Dr. Nicholson,

 5 the testimony of his research coordinator and the

 6 study documents showed that the fractures reported

 7 in this published study are largely attributable to

 8 one single implanting physician, that could impact

 9 the reliability of the conclusions, couldn't it?

10 MR. MATTHEWS: Object to the form.

11 THE WITNESS: I don't know. I don't

12 think I have enough information to be able to answer

13 that question. I could think of a number of

14 different reasons why one physician would have a

15 higher incidence of such complications, the most

16 obvious one being he was the principal implanter of

17 these devices.

18 BY MS. HELM:

19 Q. If the patients in the study whose

20 filters did not fracture were excluded and only

21 patients whose filters fractured were included, that

22 would impact the reliability of the conclusions of

23 the study, wouldn't it?

24 MR. MATTHEWS: Object to the form.

25 THE WITNESS: I'm sorry, could you

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 31 of 36
Page 118

 1 rephrase that for me?

 2 MS. HELM: Sure.

 3 THE WITNESS: I'm not sure I

 4 understand the question.

 5 BY MS. HELM:

 6 Q. If the study -- if in the study they

 7 only looked at patients whose filters fractured and

 8 they excluded patients who were part of a study but

 9 whose filters did not fracture, that would impact

10 the reliability of the conclusions, wouldn't it, if

11 they self-selected out patients?

12 A. Could you further explain that?

13 Q. Sure. If the study only analyzes the

14 fracture -- the patients whose filters fractured --

15 A. Yes.

16 Q. -- and did not include the patients

17 who were in the study but whose filters did not

18 fracture --

19 A. Yes.

20 Q. -- that would impact the reliability

21 of the conclusions; do you agree?

22 MR. MATTHEWS: Object to the form.

23 THE WITNESS: I'm not sure. I don't

24 know that I have enough information to be able to

25 answer that question.

Page 119

 1 You have to keep in mind that this is

 2 a retrospective review of a particular practice and

 3 their experience with these filters with a

 4 relatively small number of patients and also a

 5 relatively small number of complications.

 6 I don't know that you can base your

 7 practice off this one report. I think a report like

 8 this has to be looked at, considered. I haven't had

 9 enough time to go through it, through their

10 statistical methods, through their results to be

11 able to give you any intelligent opinion as to

12 whether or not I would alter my practice based on

13 this one report.

14 Just by virtue of the design of the

15 study, I would have to say no. It would be something

16 that might potentially raise some concerns and cause

17 me to think twice, but I'm not so sure that this is

18 something that I would take to the bank, so to

19 speak.

20 BY MS. HELM:

21 Q. Fair enough.

22 MR. MATTHEWS: Object as

23 nonresponsive.

24 BY MS. HELM:

25 Q. If you were -- would it be important

Page 120

 1 for you to know, in evaluating Exhibit-7, that in

 2 2012 Dr. Nicholson published a correction to this

 3 study?

 4 A. Yes.

 5 Q. And in -- and if in that correction

 6 he acknowledges various errors in the study, that is

 7 something you would want to know in evaluating it,

 8 wouldn't you?

 9 A. Yes. But I think that an educated

10 observer should be able to read a paper like this

11 and draw those conclusions himself. But, yes, that

12 would be pertinent information, and I would like to

13 have that, absolutely.

14 Q. Are you still implanting filters

15 today?

16 A. Yes, I am.

17 Q. And has your practice changed today

18 from 2007?

19 MR. LERNER: You'd have to clarify

20 that question.

21 MS. HELM: Sure. That's fair enough.

22 BY MS. HELM:

23 Q. As far as follow-up of your patients,

24 has your practice changed today from 2007?

25 A. Little. Has my practice changed in

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 31 (118 - 121)

Page 121

 1 general? Yes, of course. I think we alluded to

 2 that previously in the sense that we have pushed

 3 away from using filters and make sure that when we

 4 use them, we use them in those patients who have

 5 absolute indications for implantation.

 6 Q. Doctor, you were asked a number of

 7 times today, if something is true, would that have

 8 impacted your decision of whether to use a certain

 9 filter or not.

10 Do you recall those questions?

11 A. Yes, I do.

12 Q. What you have not been provided today

13 is with any peer-reviewed or reliable information

14 showing that those "ifs" are, in fact, true; is that

15 right?

16 MR. MATTHEWS: Object to the form.

17 MR. LERNER: That's more a statement

18 than a question, don't you think?

19 THE WITNESS: I agree.

20 BY MS. HELM:

21 Q. And for you to make an evaluation and

22 to make a decision relating to whether you would

23 have done something or not, it would be important

24 for you to have reliable and complete information;

25 is that right?

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 32 of 36
Page 122

 1 A. Yes.

 2 MS. HELM: That's all I have right

 3 now.

 4 MR. MATTHEWS: I have just some quick

 5 follow-ups.

 6 THE WITNESS: Okay.

 7 - - -

 8 EXAMINATION

 9 - - -

10 BY MR. MATTHEWS:

11 Q. You were just asked about

12 peer-reviewed information that's been put in front

13 of you.

14 A. Yes.

15 Q. The Nicholson article is a

16 peer-reviewed journal article; is that correct?

17 A. It is.

18 Q. And let me show you the next exhibit,

19 which is the VJ study, which is called --

20 MS. HELM: What exhibit?

21 MS. BLAS: 12.

22 - - -

23 (Whereupon, Exhibit-12, Fractured

24 Bard Recovery, G2, and G2, Express Inferior Vena

25 Cava Filters: Incidence, Clinical Consequences, and

Page 123

 1 outcomes of Removal Attempts, was marked for

 2 identification.)

 3 - - -

 4 BY MR. MATTHEWS:

 5 Q. It's called, Fractured Bard Recovery,

 6 G2 and G2 Express Interior Vena Cava Filters,

 7 Incidence, Clinical Consequences and Outcomes of

 8 Removal Attempts.

 9 This is in the Journal of Vascular

10 and Interventional Radiology, 2012. That's also a

11 peer-reviewed journal article, correct?

12 A. It is.

13 Q. And the results is -- the results

14 are, A total of 63 fractured Recovery, G2, G2

15 Express were identified, for an overall fracture

16 rate of 12 percent.

17 So this is a second peer-reviewed

18 journal that talks about the fracture rate of the

19 G2, correct?

20 A. Correct.

21 Q. Let me show you the Deso study, which

22 is also a peer-reviewed journal article comparing

23 the filters, G2, with other filters, in terms of

24 their fracture rate. And we're going to mark this

25 as Exhibit-13.

Page 124

 1 - - -

 2 (Whereupon, Exhibit-13,

 3 Evidence-Based Evaluation of Inferior Vena Cava

 4 Filter Complications Based on Filter Type, was

 5 marked for identification.)

 6 - - -

 7 BY MR. MATTHEWS:

 8 Q. This is in Interventional Radiology,

 9 also a peer-reviewed journal article, by Deso,

10 Idakoji and William Kuo.

11 If I could turn your attention to the

12 Table 2.

13 A. Sorry about that, I just wanted to

14 read that first paper.

15 Q. It's okay.

16 I was just trying to move it along,

17 but you can take as long as you want.

18 Have you seen this article before?

19 A. I have not.

20 Q. All right. This is from the Division

21 of Vascular and Interventional Radiology at Stanford

22 University. And this was published in 2012.

23 And if I could turn your attention to

24 Table 2 on the fifth page.

25 A. Okay.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 32 (122 - 125)

Page 125

 1 Q. This table, Doctor.

 2 A. Okay.

 3 Q. I think it's the fifth page or so,

 4 Page 97.

 5 A. Okay.

 6 Q. Have you seen the comparison of

 7 filters and the fracture rate between filters before

 8 today?

 9 MR. LERNER: Are you talking about

10 that page?

11 THE WITNESS: No.

12 MR. MATTHEWS: I'm sorry?

13 MR. LERNER: Are you talking about

14 that page?

15 BY MR. MATTHEWS:

16 Q. Well, actually, the question is more

17 general than that.

18 Have you seen a comparison of

19 filters, the fracture rates between published

20 journal articles, such as we see in Table 2?

21 A. I have not seen this particular paper

22 before, and I have not seen data like this before.

23 Q. Is that a peer-reviewed journal

24 article as well?

25 A. It is.

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 33 of 36
Page 126

 1 Q. Just a few more questions, Doctor, in

 2 response to some questions that you were just asked.

 3 Doctors such as yourself, to a

 4 certain extent, have to rely on industry to do the

 5 proper tests and studies to show safety and efficacy

 6 before a product is sold; is that true?

 7 MS. HELM: Object to the form.

 8 THE WITNESS: I would say yes.

 9 BY MR. MATTHEWS:

10 Q. Had you known at the time of implant

11 that there was up to a 25 percent risk of a

12 fractured filter in the G2, would you have taken

13 steps to ensure that that filter was retrieved from

14 Ms. Booker after implant?

15 A. Yes.

16 Q. If you would have known there was up

17 to a 25 percent risk of filter fracture in that G2,

18 as we've seen in the articles in front of you, you

19 would have taken greater steps than what were taken

20 to make sure that filter was removed after implant

21 with that patient on that -- in that year, correct?

22 MS. HELM: Object to the form.

23 THE WITNESS: Knowing what I today, I

24 think it's safe to answer that question as yes.

25 Given the information we had at hand back then, I'm

Page 127

 1 not so sure anything would have changed. But, yes,

 2 we make an effort to follow our patients back then

 3 as now.

 4 BY MR. MATTHEWS:

 5 Q. Let me ask you about that, in terms

 6 of the fracture rate.

 7 Has Bard ever suggested a protocol

 8 for your hospital, knowing what we know today, to

 9 follow those patients that had Recovery and G2

10 filters to make sure that they are retrieved once

11 the risk of PE has subsided?

12 MS. HELM: Object to the form.

13 THE WITNESS: No.

14 MR. MATTHEWS: Pass the witness.

15 - - -

16 EXAMINATION

17 - - -

18 BY MS. HELM:

19 Q. Doctor, the decision of whether or

20 how to treat a follow-up patient, you would agree

21 with me that's a medical decision, wouldn't you?

22 A. Yes.

23 Q. And it needs to be made by a medical

24 doctor with medical training?

25 A. Yes.

Page 128

 1 Q. And not by a device manufacturer?

 2 A. Yes.

 3 Q. These two articles that you've just

 4 been asked about, Exhibits-12 and 13, you have not

 5 had an opportunity to review or examine them, have

 6 you?

 7 A. I have not.

 8 Q. And I don't know which is which, the

 9 Deso evidence based --

10 A. That would be 13.

11 Q. Okay. That article is a -- are you

12 aware that that article is actually a literature

13 review and not a study?

14 A. That's briefly what it looks like,

15 yes, ma'am. But I have not had a chance to read

16 this yet.

17 Q. And that article -- and I -- this is

18 a statement not a question.

19 A. Yes.

20 Q. That article also cites to an article

21 by Dr. Lynch relating to a perforation rate of G2

22 filters.

23 I assume you've never spoken with Dr.

24 Lynch about --

25 A. I have not.

Do Not Disclose - Subject to Further Confidentiality Review

Golkow Technologies, Inc. Page 33 (126 - 129)

Page 129

 1 Q. -- this article or his study; is that

 2 right?

 3 A. That's right.

 4 Q. So you don't have any way of knowing

 5 whether Dr. Lynch actually agrees with the

 6 representation of his study in the Deso, Kuo

 7 article, do you?

 8 A. I have not.

 9 Q. And the other article, the one that

10 starts, Fractured Bard Recovery, we talked about it

11 previously, that's a retrospective case series, is

12 it not?

13 A. Yes.

14 Q. And you have not had an opportunity

15 to evaluate that or determine whether these doctors'

16 experience was the same as yours with the Recovery

17 or G2 filter; is that right?

18 A. That's right.

19 Q. So, again, it's a source of

20 information out there, but it's a source of

21 information that you would have to study and

22 evaluate and determine its reliability and impact on

23 your decision-making; is that right?

24 A. That's fair to say, yes.

25 Q. And you can't -- have not had the

Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 34 of 36
Page 130

 1 opportunity to do that today?

 2 A. That's right.

 3 MS. HELM: That's all I have.

 4 MR. MATTHEWS: I think we're done.

 5 Thank you.

 6 THE WITNESS: Thank you.

 7 VIDEO TECHNICIAN: This concludes

 8 today's deposition. The time is 3:37. We are off

 9 the record.

10 - - -

11 (Whereupon, the deposition was

12 concluded at 3:37 p.m.)

13 - - -

14

15

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Page 131

 1 CERTIFICATE

 2

 3

 4 I HEREBY CERTIFY that the witness was

 5 duly sworn by me and that the deposition is a true

 6 record of the testimony given by the witness.

 7

 8

 9

 Amanda Maslynsky-Miller

10 Certified Realtime Reporter

 Dated: March 27, 2017

11

12

13

14

15

16 (The foregoing certification of this

17 transcript does not apply to any reproduction of the

18 same by any means, unless under the direct control

19 and/or supervision of the certifying reporter.)

20

21

22

23

24

25

Page 132

 1 INSTRUCTIONS TO WITNESS

 2

 3 Please read your deposition over

 4 carefully and make any necessary corrections. You

 5 should state the reason in the appropriate space on

 6 the errata sheet for any corrections that are made.

 7 After doing so, please sign the

 8 errata sheet and date it.

 9 You are signing same subject to the

10 changes you have noted on the errata sheet, which

11 will be attached to your deposition.

12 It is imperative that you return the

13 original errata sheet to the deposing attorney

14 within thirty (30) days of receipt of the deposition

15 transcript by you. If you fail to do so, the

16 deposition transcript may be deemed to be accurate

17 and may be used in court.

18

19

20

21

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25

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Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 35 of 36
Page 134

 1

 I,_____________________, do hereby

 2 certify that I have read the foregoing pages, 1 -

 130, and that the same is a correct transcription of

 3 the answers given by me to the questions therein

 propounded, except for the corrections or changes in

 4 form or substance, if any, noted in the attached

 Errata Sheet.

 5

 6 _______________________________________

 MARCUS D'AYALA, M.D. DATE

 7

 8

 Subscribed and sworn

 9 to before me this

 _____ day of ______________, 20____.

10

 My commission expires:______________

11

12 ____________________________________

 Notary Public

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Case 2:15-md-02641-DGC Document 8574-1 Filed 11/02/17 Page 36 of 36