Exhibit K

Case 2:15-md-02641-DGC Document 8221-2 Filed 10/18/17 Page 1 of 5
Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 1

 1 UNITED STATES DISTRICT COURT

 2 DISTRICT OF ARIZONA

 3 ------------------------------x

 IN RE: BARD IVC FILTERS :

 4 PRODUCTS LIABILITY :

 LITIGATION :

 5 :

 : Case No.:

 6 : MD-15-02641-PHX-DGC

 ------------------------------x

 7 DO NOT DISCLOSE - SUBJECT TO FURTHER

 8 CONFIDENTIALITY REVIEW

 9 July 28, 2017

 10 Washington, D.C.

 11 Videotaped Deposition of:

 12 RONALD A. THISTED,

 13 Called for oral examination by counsel for

 14 Plaintiff, pursuant to notice, at the offices

 15 of Nelson Mullins, 101 Constitution Avenue, NW,

 16 9th Floor, Washington, D.C. beginning at 8:55

 17 a.m., before Teague Gibson, a Notary Public.

 18

 19

 20 * * * * *

 21

 22

 23

 24

 25

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Do Not Disclose - Subject to Further Confidentiality Review

Golkow Litigation Services Page 165

 1 A Accept by accident, they might turn out

 2 for other reasons to have recorded something that

 3 turns out to be a confounder, but.

 4 Q So if after the study is completed they

 5 determine that there are one or more confounders

 6 that were either unmeasured or were previously

 7 unknown and now are identified as potential

 8 confounders, wouldn't you turn to external sources

 9 of data to gain information about those potential

 10 confounders?

 11 MR. BUSMAN: Object to the form.

 12 A Some sources of information might tell you

 13 how often those confounders occurred in a particular

 14 population, others may have been the basis for

 15 identifying it as something that affects the

 16 outcomes and those might play into an analysis of

 17 the extent to which those -- that confounder could

 18 have affected the outcomes of the PRESERVE study,

 19 but they wouldn't tell you the answer to the

 20 question that PRESERVE study is intended to answer.

 21 Q Do you agree that MAUDE is part of FDA

 22 adverse events surveillance system?

 23 A Yes.

 24 Q As we discussed, drug reports go into a

 25 separate database, but it's similar in the sense

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Do Not Disclose - Subject to Further Confidentiality Review

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 1 they're both collecting spontaneous adverse events,

 2 right?

 3 MR. BUSMAN: Object to the form.

 4 A They're collecting -- both MAUDE and the

 5 FDA adverse event reporting system are recruiting

 6 both spontaneous adverse event reports -- yeah, they

 7 both collect spontaneous adverse event reports.

 8 Q And do you agree that the FDA advises

 9 medical device manufacturers to calculate reporting

 10 rates, that is adverse event -- reported adverse

 11 events against sales or some other source or

 12 exposure information?

 13 MR. BUSMAN: Object to the form.

 14 A I'm aware that FDA has guidance that

 15 suggests as a signal detection measure that one

 16 calculate crude rates of adverse events against a

 17 measure of exposure. In the context of drugs one,

 18 again, crude measure of exposure is number of

 19 prescriptions sold. And the reason that's at least

 20 a plausible measure of exposure is that the longer a

 21 person is on a particular drug, the more

 22 prescriptions they fill. So the more prescriptions

 23 reflects extent of exposure. And someone who's on a

 24 drug for a short time will have fewer prescriptions

 25 than individuals on for a long time.

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 1 Same thing can't be -- isn't true for things

 2 like devices where number of sales is the number of

 3 implants but has no relationship to exposure, other

 4 than initial exposure. But in the context of drugs,

 5 FDA does suggest looking at crude estimates of

 6 adverse event rates.

 7 Q And, in fact, they say that comparison of

 8 reporting rates and their temporal trends can be

 9 valuable, particularly across similar products or

 10 across different product classes?

 11 MR. BUSMAN: Are you reading from -- I'm

 12 just -- quick question. Is this a quote that

 13 you're reading from or is it a question?

 14 Q I'm just asking a question.

 15 A I believe that's consistent with the 2005

 16 guidance document on pharmacovigilance, but it can

 17 be helpful in identifying possible trends but that

 18 same document goes on to describe the limitations of

 19 such things. It says, in particular, that because

 20 reporting to change over time because there can be

 21 differences in reporting rates for different drugs

 22 or different products, that they can't be relied

 23 upon for making causal comparisons between two

 24 products.

 25 Q The 2005 guidance document, is that the

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