Exhibit H

Case 2:15-md-02641-DGC Document 8230-2 Filed 10/18/17 Page 1 of 6
Deposition of:

Rebecca Betensky , Ph.D.

June 23, 2017

In the Matter of:

In Re: Bard IVC Filters Products

Liability

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Case 2:15-md-02641-DGC Document 8230-2 Filed 10/18/17 Page 2 of 6
Rebecca Betensky , Ph.D. June 23, 2017

In Re: Bard IVC Filters Products Liability

1 Because you didn't have data for adverse

2 events for SNF prior to 2000 and you didn't have sales

3 data for SNF prior to 2000, there's no way for you, as

4 you sit here today, to say that if you had that data

5 and calculated reporting risk ratios perhaps the

6 reporting risk ratios would be greater for SNF over

7 removable, maybe they'd be lower. You just don't know

8 one way or another, right?

9 A I don't have the data so I don't know what

10 the number would be if I had had the data. It could

11 go -- like you said, I could get -- I could have gotten

12 RRs that are larger than what I got. I could have

13 gotten RRs that are smaller than what I got.

14 Q Now, because you didn't have adverse --

15 strike that.

16 Based on the Weber effect, it would be more

17 likely to find the greatest number of adverse events in

18 connection with the SNF sometime within the first ten

19 years it was on the market, right?

20 MR. MANKOFF: Object to form.

21 A So --

22 THE WITNESS: I'm sorry. Can you

23 restate that?

24 Q We were going -- I had asked you some

25 questions about the Weber effect, and, and perhaps I

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Case 2:15-md-02641-DGC Document 8230-2 Filed 10/18/17 Page 3 of 6
Rebecca Betensky , Ph.D. June 23, 2017

In Re: Bard IVC Filters Products Liability

1 for newer devices on the market as opposed to older

2 devices, right?

3 MR. MANKOFF: Object to form.

4 A Again, my understanding is that this is a

5 sys -- it's a complex system and that is -- one driver

6 of reporting is the newness of the device, but there

7 are other -- may be other drivers as well.

8 Q Let me see if I can restate that.

9 One driver of reporting that you understand

10 exists for medical devices in a general sense is that

11 newer medical devices are likely to receive more

12 reports as recorded in MAUDE than older devices, right?

13 A I don't know about likely. I can't say are

14 likely to. I can say that's a possibility.

15 Q Let me try it again.

16 You recognize that it's possible that newer

17 devices have more MAUDE reports of adverse events than

18 older devices, right?

19 A That's possible.

20 Q In your analysis you captured periods in

21 which the removal devices were new to the market,

22 right?

23 A Yes.

24 Q In your analysis you didn't start considering

25 adverse events for the Simon Nitinol filter until it

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Case 2:15-md-02641-DGC Document 8230-2 Filed 10/18/17 Page 4 of 6
Rebecca Betensky , Ph.D. June 23, 2017

In Re: Bard IVC Filters Products Liability

1 had been on the market for over ten years, right?

2 A I believe that's true.

3 Q *You did not do an apples-to-apples

4 comparison of time periods for any of the removable

5 filters as compared to the analogous time periods in

6 which the Simon Nitinol filter had been on the market,

7 right?

8 MR. ROTMAN: Please reread that

9 question.

10 (*Record read)

11 MR. MANKOFF: Object to form.

12 THE WITNESS: I'm sorry. Can you

13 restate that, please.

14 MR. BUSMAN: Sure.

15 Q If you really wanted to do an accurate and

16 meaningful comparison between various of the Recovery

17 filters and the Simon Nitinol filter, you would have

18 wanted to compare MAUDE reports for any of the

19 recoverable filters in the first few years those

20 filters had been on the market as compared to the

21 reports for the first few years when the Simon Nitinol

22 filter was on the market, right?

23 MR. MANKOFF: Object to form.

24 A Well, that's one analysis certainly, but I

25 guess I'm -- or let me back up. But another way of

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Case 2:15-md-02641-DGC Document 8230-2 Filed 10/18/17 Page 5 of 6
Rebecca Betensky , Ph.D. June 23, 2017

In Re: Bard IVC Filters Products Liability

1 might have on the number of reports in the MAUDE

2 database for removable filters?

3 A So again, I wasn't using the MAUDE database

4 directly. I was using Bard's data which as I've said

5 I -- my understanding is overlaps with the MAUDE

6 database, but not necessarily entirely. So, so I'm

7 not -- I don't know how reporting -- I, I didn't take

8 into account potential changes in reporting.

9 Q Based on litigation?

10 A Based on litigation.

11 Q What, if anything, did you do in this case to

12 take into account the fact that the Simon Nitinol,

13 which was ten-years-old at the time that your analysis

14 began, may have been less likely to receive reports

15 than newer products?

16 MR. MANKOFF: Object to form.

17 A So again, I didn't have the data for that

18 first ten years. And, I believe also that there is

19 some value, there is value to be comparing these

20 devices contemporaneously, so at the same time.

21 So if I had had the data for the first ten

22 years, I would have used it. I would have probably

23 done both analyses, the one starting at 2000 to align

24 everything in calendar time when -- you know, to

25 control for medical advance, potential medical

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