Exhibit B

Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 1 of 7
Deposition of:

David Kessler , M.D.

October 5, 2016

In the Matter of:

Clare-Austin vs. C.R. Bard

Tiffany Alley, A Veritext Company

1075 Peachtree St. NE , Suite 3625

Atlanta, GA, 30309

800.808.4958 | calendar-ga@veritext.com | 770.343.9696

Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 2 of 7
David Kessler , M.D. October 5, 2016

Clare-Austin vs. C.R. Bard

1 Julia has an associate, Laura Smith, in her firm. I

2 believe Ramon, you have an associate, Nicholas --

3 MR. LOPEZ: Graham.

4 THE WITNESS: -- Graham. I'm not sure I've

5 met -- been in the same room as Nicholas. I've talked

6 to Nicholas.

7 MR. LOPEZ: He's going to be happy his name is

8 on the transcript.

9 BY MR. NORTH:

10 Q. Prior to the time you were contacted by

11 Mr. Cartmell to become involved in this litigation, had

12 you had any professional involvement with inferior vena

13 cava filters?

14 MR. LOPEZ: I'll object as to form.

15 THE WITNESS: So I have one, one recollection,

16 I mean, that is in my memory. Obviously, I mean, with

17 regard to the 1990s, we have to check the records to see

18 whether ExecSec has records of my being involved in vena

19 cava filters. I just don't have a recollection sitting

20 here today.

21 But there is one other -- what was the actual

22 question you asked? Have you had any professional

23 involvement, I think, was the way you phrased it. So I

24 want to be careful here because I don't want to breach

25 any lawyer-attorney work product here. But I think it's

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Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 3 of 7
David Kessler , M.D. October 5, 2016

Clare-Austin vs. C.R. Bard

1 fair to say I was approached -- I was approached by NBC

2 lawyers, I was approached to explain to NBC lawyers the

3 regulatory framework for medical devices, and

4 specifically inferior vena cava filters. I have

5 a recollection of that.

6 BY MR. NORTH:

7 Q. Was that in connection with the NBC broadcast

8 regarding Bard filters?

9 A. I believe it was prior to that, sir. I believe

10 I -- my recollection is I got a phone call and asking if

11 I could explain to lawyers how medical devices and

12 inferior vena cava filters were regulated under federal

13 law. I have a recollection of that, I have a

14 recollection of doing that.

15 Q. Do you recall the time frame generally when

16 that contact was made?

17 A. It was a number of years ago. It was prior to

18 the broadcast, I believe. I don't have a specific date

19 in my head.

20 Q. So was it -- the broadcasts were in 2015. Was

21 it prior to 2015?

22 A. Do you know when in 2015 the broadcast --

23 Q. July was the first -- no, September was the

24 first one and December the second one.

25 A. I wouldn't want to -- I mean, I'm under oath.

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Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 4 of 7
David Kessler , M.D. October 5, 2016

Clare-Austin vs. C.R. Bard

1 it's the manufacturer that has the responsibility to

2 assure safety. 510(k) is not a -- I mean, it's evolved,

3 I guess, and, you know, FDA can at certain points for

4 certain reasons ask for additional studies, but it's

5 not -- it's not a review of safety and effectiveness.

6 Q. The 1990 Act also added some special controls

7 governing Class 2 devices, didn't it?

8 A. Yes. For example, the guidance that you raised

9 in 1999 were in fact special controls -- right? -- so

10 they were, in essence, performance standards that had

11 to be met. But they were really part -- performance

12 standards were always contemplated to be part of Class 2

13 devices.

14 Can I just see the 1999 one more second? I

15 want to double-check myself and make sure I didn't

16 misspeak.

17 MR. LOPEZ: Sure.

18 THE WITNESS: So I just want to make sure. I'm

19 sorry, this is not -- I don't see any of them, I'm

20 sorry. Give me one more second.

21 So here it is. So -- I apologize.

22 There is -- I just want to get the exact quote in

23 double-checking myself. I'm pretty sure it says

24 migration has to be reported greater than five, when

25 there's migration greater than five millimeters -- if

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Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 5 of 7
David Kessler , M.D. October 5, 2016

Clare-Austin vs. C.R. Bard

1 someone can help me see where that is in the document?

2 Does anyone know what page that's on?

3 So here it is. Let me not waste your time, but

4 if someone can help me see if there's greater than five

5 millimeter increments? I thought I remembered that.

6 I apologize.

7 BY MR. NORTH:

8 Q. Do you intend to offer an opinion in this case

9 that the G2 filter is defectively designed?

10 A. That's what -- I don't want to use the

11 term -- I mean, I don't know if that's a legal

12 conclusion.

13 What I did -- I mean, G2 was adulterated, okay?

14 G2 did not pass the caudal migration testing. And I

15 checked -- I just checked at lunch just to add -- you

16 asked me about Austin and tilt, and, I mean, she's a

17 classic case. But the radiological report there, you

18 asked me about tilt. The radiological report, I think

19 on 11-13 2013, 11-19 2013 --

20 THE REPORTER: I'm sorry, doctor. The date?

21 THE WITNESS: It was either 11-13 or 11-19 -- I

22 can pull it up in a second -- 2013, said the filter was

23 horizontal. So you don't need to be a radiologist to

24 know that horizontal is not just a little tilt but is

25 reported as horizontal.

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Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 6 of 7
David Kessler , M.D. October 5, 2016

Clare-Austin vs. C.R. Bard

1 But G2 failed its caudal migration test. It

2 actually failed the migration resistance test -- Bard

3 changed the standards -- but it was represented as

4 having greater stability. It clearly failed caudal

5 migration and, therefore, it was adulterated. So

6 obviously, again, obviously it was defective. It was

7 also -- should have never been on the market also

8 because Recovery was -- should have never been on the

9 market and Recovery was the predicate. Recovery should

10 have been taken off way before the G2 came on and the G2

11 would not have had a predicate.

12 So it was adulterated, I think is probably the

13 right way for me to say it. It certainly was -- there

14 was evidence that it failed to maintain its standard --

15 right? -- of, I mean, increased stability. It was

16 not -- it had greater caudal migration in G2 than RNF

17 and SNF and failed in performance. The exact defect

18 that Clare Austin had -- not defect, the adverse event

19 that she had, so it was clearly defective.

20 Q. So it your testimony that the filter in

21 Ms. Austin caudally migrated?

22 A. I believe it caudally migrated. Others can

23 testify to that. It's certainly horizontal, I believe

24 it caudally migrated, that was my impression from the

25 medical record, but I'll let other doctors talk about

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Case 2:15-md-02641-DGC Document 8231-2 Filed 10/18/17 Page 7 of 7