Exhibit I

Case 2:15-md-02641-DGC Document 8230-3 Filed 10/18/17 Page 1 of 5
Deposition of:

Rebecca Betensky , Ph.D.

July 26, 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 8230-3 Filed 10/18/17 Page 2 of 5
Rebecca Betensky , Ph.D. July 26, 2016

Clare-Austin vs. C.R. Bard

1 Q. But it was clear, even if you didn't

2 perform the exact calculations, it was clear that

3 the frequency of these reported adverse events was

4 not huge; correct?

5 MR. MANKOFF: Object to form.

6 A. Correct, relative to the reported sales

7 numbers and the reported events, that's correct.

8 Q. Now, you've been using and we've been using

9 interchangeably as you said reported risk ratio,

10 that term, with reported relative risk. How does a

11 reported relative risk differ from a relative risk?

12 A. So the qualifier "reported" is important,

13 and that's indicating that the data are coming from

14 reports, and are not being derived from a

15 beautifully run and designed experiment like a

16 clinical trial, in which there's perfect follow-up

17 and in which it's really a true experiment.

18 So the "reporting" qualifier is there to

19 say and to suggest that these are numbers that are

20 reported. These are based on reports.

21 Q. And that's different from a true relative

22 risk; correct?

23 A. A relative risk, which is what the target

24 is, which is what would be of interest, wouldn't be

25 entangled with issues around reporting.

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Tiffany Alley, A Veritext Company

800.808.4958 770.343.9696

Case 2:15-md-02641-DGC Document 8230-3 Filed 10/18/17 Page 3 of 5
Rebecca Betensky , Ph.D. July 26, 2016

Clare-Austin vs. C.R. Bard

1 Q. And we don't know whether that occurred in

2 this instance with this particular data set, do we?

3 MR. MANKOFF: Object to form.

4 A. We don't whether what occurred?

5 Q. Underreporting or overreporting. You said

6 it could lead to it.

7 A. No --

8 Q. We don't know whether it led to either way

9 in this case, do we?

10 A. I'm sorry; I said --

11 MR. MANKOFF: Just let the court

12 reporter catch up.

13 Object to form.

14 A. Okay. I didn't say anything about

15 overreporting. What I said was overestimates. So

16 these data could -- they provide an estimate, we

17 call it the reporting risk ratio. And this estimate

18 could be an overestimate or it could be an

19 underestimate.

20 Q. Okay, and I stand corrected. Let me

21 rephrase that question.

22 And we cannot say, sitting here today,

23 whether the reported relative risk that you

24 calculated overestimates or underestimates in this

25 particular data set, can we?

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Tiffany Alley, A Veritext Company

800.808.4958 770.343.9696

Case 2:15-md-02641-DGC Document 8230-3 Filed 10/18/17 Page 4 of 5
Rebecca Betensky , Ph.D. July 26, 2016

Clare-Austin vs. C.R. Bard

1 respect to that is just looking at the sales data

2 over time across ten years of time for some

3 products, and less so for others because they were

4 removed from the market earlier. The sales data

5 seems pretty constant month by month, which is the

6 granularity at which I have the data.

7 So I would imagine that these are

8 expensive devices and nobody wants too many of them

9 sitting on the shelf; and so over time, institutions

10 or physicians learn better how to estimate their

11 needs, and so that wouldn't be a very big problem.

12 So I did also address that through one

13 of my sensitivity analyses, and just assumed -- or

14 just considered what would happen if I discounted

15 the sales data by 20 percent and just assumed that

16 20 percent are sitting on the shelf and 80 percent

17 are implanted, and I obtained comparable results to

18 when I didn't do that discounting.

19 Q. Other limitations?

20 A. So another limitation is that these are

21 crude estimates of risk and reflect different times

22 of exposure to devices, partly due to when the SNF,

23 for example, was available prior to the start time

24 of 2000; also reflecting the permanent versus

25 retrievable issue.

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Case 2:15-md-02641-DGC Document 8230-3 Filed 10/18/17 Page 5 of 5