Exhibit B-1

Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 1 of 10
Deposition of:

Mark Eisenberg , M.D.

July 6, 2017

In the Matter of:

In Re: Bard IVC Filters Products

Liability

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 2 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 are knowledgeable about the risks and benefits

2 associated with the procedure and the device.

3 That's dependent on having that information

4 available to them.

5 Q. Let me hand you what we will mark as

6 Exhibit 8.

7 Exhibit 8 was marked for

8 identification.

9 BY MR. BUSMAN:

10 Q. Do you recognize this as the

11 document identified in paragraph 24?

12 A. Yes.

13 Q. Take a look at the very top, if you

14 will, right under the heading: "Chapter Two,

15 Opinions on Consent, Communications and Decision

16 Making". I will read it into the record.

17 "The opinions in this chapter

18 are offered as ethics guidance

19 for physicians and are not

20 intended to establish

21 standards of clinical practice

22 or rules of law."

23 Did I read that correctly?

24 A. Yes.

25 Q. Do you agree with that statement?

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 3 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 Q. Let's take a look, please, at

2 paragraph 26. If you could read that to yourself

3 and let me know when you are finished.

4 A. Okay.

5 Q. Let me hand you what we will mark as

6 Exhibit 9.

7 Exhibit 9 was marked for

8 identification.

9 BY MR. BUSMAN:

10 Q. Can you identify Exhibit 9 for the

11 record, please?

12 A. This is titled: "The ACR-SIR-SPR

13 Practice Parameter on Informed Consent For Image

14 Guided Procedures."

15 Q. Is the document we have identified

16 as Exhibit 9 the document that you refer to in

17 paragraph 26 of your report?

18 A. The paragraph in my report -- the

19 paragraphs in my report are sub-sections from

20 this document.

21 Q. Now, Exhibit 9 is a document put out

22 by the American College of Radiology; right?

23 A. Yes.

24 Q. In connection with what other

25 groups?

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 4 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 A. With the Society of Interventional

2 Radiology and the SPR.

3 Q. Do you know what SPR stands for?

4 A. I think the acronym escapes me for

5 the moment.

6 Q. Now, are you a member of the

7 American College of Radiology?

8 A. No, I am not.

9 Q. Are you eligible to become a member

10 of the American College of Radiology?

11 A. That I don't know. As I said, I am

12 an interventional cardiologist, so there is some

13 overlap between radiology and interventional

14 cardiology, so it's possible I might be eligible.

15 Q. Are you a member of the Society of

16 Interventional Cardiology?

17 A. No, I am not.

18 Q. There is nothing in paragraph 26 of

19 your report that quotes from these practice

20 guidelines that specifically mentions any

21 obligation, responsibility or duty on behalf of a

22 medical device manufacturer; right?

23 A. No. As we mentioned earlier, there

24 is no specific mention in these paragraphs of the

25 responsibility of a medical device manufacturer,

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 5 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 although I think there is -- it's implicit in

2 these paragraphs, because these paragraphs

3 discuss how a physician obtains informed consent

4 before doing a procedure, and they have to be

5 able to disclose to the patients the risks,

6 complications and expected benefits of the

7 procedure or device to the patient. So in order

8 to be able to do that they have to know what the

9 risks, complications and benefits are and how

10 frequently they occur.

11 Q. I am going to object and move to

12 strike as non-responsive. Is there anything in

13 paragraph 26 where you quote from these practice

14 guidelines that specifically references any

15 binding duty, obligation or responsibility of a

16 medical device manufacturer?

17 MR. ROTMAN: Objection. Asked and

18 answered.

19 THE WITNESS: No, there is nothing

20 specifically, you know, identifying the

21 responsibility of a medical device company in

22 these paragraphs.

23 BY MR. BUSMAN:

24 Q. Is Exhibit 9, in your opinion, the

25 same type of document as Exhibit 8 in terms of

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 6 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 providing ethical guidance to practitioners?

2 A. Yes, very similar.

3 Q. Now, if you take a look at

4 Exhibit 9, I am going to read part of it into the

5 record. If you take a look at the preamble on

6 the first page. Do you see that heading?

7 A. Yes.

8 Q. "This document is an

9 educational tool designed to

10 assist practitioners in

11 providing appropriate

12 radiologic care for patients."

13 Did I read that correctly?

14 A. Yes.

15 Q. Do you agree?

16 A. Yes.

17 Q. The next sentence states:

18 "Practice parameters and

19 technical standards are not

20 inflexible rules or

21 requirements of practice and

22 are not intended nor should

23 they be used to establish a

24 legal standard of care."

25 Did I read that correctly?

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 7 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 are provided by these organizations to provide

2 guidance to physicians on how to obtain informed

3 consent. At the same time, they don't want to

4 expose the physicians to lawsuits if they, you

5 know, if they haven't enumerated every single

6 risk or every single benefit. So they don't want

7 to -- they don't want to set this up as a way

8 for, I think, patients to sue physicians.

9 Q. Would I be correct that, in your

10 opinion, the documents cited in paragraphs 24, 25

11 and 26 do not constitute any legally binding

12 obligations for Bard?

13 MR. ROTMAN: Objection.

14 THE WITNESS: I think that they --

15 first of all, it doesn't appear that they are

16 legally binding obligations for physicians, if I

17 understand these sentences correctly. And none

18 of these paragraphs specifically mention medical

19 device manufacturers. So technically I think you

20 are correct. On the other hand, these are, you

21 know, very strongly advised and they are widely

22 accepted amongst physicians that these are the --

23 these are the components of full and informed

24 consent. If you want to get full and informed

25 consent you have to be fully apprised of the

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 8 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 MR. ROTMAN: Objection.

2 THE WITNESS: Well, if we could turn

3 to the second part of paragraph 33 where we are

4 talking about it was misleading and detrimental

5 to patient health, safety, and informed consent

6 to continue to sell the earlier devices after the

7 newer ones had been cleared for marketing, so

8 that refers specifically to informed consent. So

9 we have earlier in my expert report a couple of

10 documents that speak to informed consent where

11 the physician has to give the risks and benefits

12 of the procedure or device.

13 BY MR. BUSMAN:

14 Q. You are talking about the documents

15 in paragraphs 24, 25 and 26; correct?

16 A. That's correct.

17 Q. Is it your opinion that the

18 documents in paragraphs 24, 25 and 26 are in some

19 way, shape or form actually binding on Bard,

20 controlling of its conduct?

21 A. No. As we discussed earlier, these

22 are strong ethical guidelines for physicians on

23 how to provide informed consent.

24 Q. So let me try the question one more

25 time. What binding document of any kind, whether

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Case 2:15-md-02641-DGC Document 8222-1 Filed 10/18/17 Page 9 of 10
Mark Eisenberg , M.D. July 6, 2017

In Re: Bard IVC Filters Products Liability

1 it be a law, rule, standard or regulation, did

2 Bard violate in connection with the conduct

3 outlined in paragraph 33?

4 A. So again, I can't point you to a

5 particular document. I would say that I have

6 read the expert report of Dr. Kessler who is an

7 FDA expert, and he indicated in his documents

8 that Bard had violated, you know, various FDA

9 rules. I can't point to the particular

10 paragraphs where he said that.

11 Q. I am going to object and move to

12 strike everything other than "I can't point you

13 to a document." I didn't ask you about Dr.

14 Kessler; okay, or his litigation report in this

15 case. I am going to take your report as a whole

16 for the purpose of my next question; okay? I am

17 referring to your expert report that we have

18 identified here and any rebuttal report or

19 supplemental report that you have served in this

20 case. You have not identified any binding

21 document of any kind, whether it be a law, rule,

22 regulation or guidance that you believe Bard

23 violated in connection with any of your expert

24 opinions in this case; right?

25 A. Again, I don't know if this gets to

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