Personal Injury Litigation

4 Q. Now, you received a letter from a Dr.
5 Snodgrass at UCLA describing two patients had who
6 had migraines with aura. Do you recall that
7 discussion?
8 A. Yes, I do.
9 Q. In his letter Dr. Snodgrass said that
10 he did not know whether the events he described had
11 anything to do with Vioxx. Do you recall that?
12 THE WITNESS: Yes, I do.
13 MR. MEADOW: Objection, leading.
14 BY MR. KIERNAN:
15 Q. Now, counsel asked you if you
16 forwarded this letter to the folks at Merck who
17 monitor adverse events. Do you recall that
18 question?
19 A. Yes, I do.
20 Q. You indicated that you had not?
21 A. That's correct.
22 Q. Following your deposition on March
23 30, 2004, did you do any followup?
24 A. Yes, I did. I went to Dr. Peter
25 Honig, who reports to me and to whom the adverse

990
1 event reporting group reports ultimately up to, and
2 I asked him what would be his advice in terms of
3 what I should do if I were to receive a letter in
4 which a potential side effect of a Merck drug was
5 disclosed to me. And his advice was that I should
6 send it to the head of the adverse event reporting
7 group, and that is a doctor called Dr. Linda
8 Hostelley.
9 And so, following that, what I did
10 was to instruct my staff to go through my
11 correspondence and to look for any correspondence
12 which contained information or potential side
13 effects with Merck drugs and to forward any and all
14 of that correspondence to Dr. Hostelley in the
15 adverse event department.
16 I also learned that there is, in
17 fact, a formal procedure and policy around all of
18 this at Merck for all employees at Merck in terms of
19 what they should do when they receive information
20 about a potential adverse event for a Merck drug.
21 So, following being briefed on that policy and
22 procedures, what I did to make sure that everyone on
23 my staff was aware of those policies, was I actually
24 requested that Dr. Hostelley come to my staff
25 meeting, and she spent about 30 minutes working

991
1 through and describing the background and what the
2 procedures are for such events were one to get
3 information about a potential side effect of a Merck
4 drug, as well as I asked her to have a meeting with
5 all of the administrative assistants for myself and
6 my staff in order to explain the procedures so that
7 as correspondence or letters come in from the
8 outside that the administrative assistants see, they
9 will also be alerted as to what the policies and
10 procedures should be followed.
11 MR. MEADOW: Objection,
12 nonresponsive.
13 MR. KIERNAN: Thank you very much,
14 Dr. Kim, that's all I have at this time.

11 Dr. Kim, I want to start with what
12 you were questioned about last during your counsel's
13 direct of you, which was this letter from Dr.
14 Snodgrass that was received by you on, I think you
15 told us, January 12, 2005, Dr. Snodgrass being a
16 physician at the University of California in Los
17 Angeles. Do you recollect that letter being
18 discussed with you a few minutes ago and also some
19 weeks ago when we discussed this matter?
20 A. Yes, I do.
21 Q. Do you recollect that the letter
22 contained a report from Dr. Snodgrass that two
23 patients that he saw with migraines who had been
24 prescribed Vioxx who were aged 17 and 24 had
25 strokes? Do you recollect that?

993
1 A. I don't recollect the details. If
2 you want to show me the letter, I'll be happy to
3 refresh my memory here.
4 Q. It is in the last paragraph, the
5 third sentence.
6 A. Yes. It says "Two patients I saw
7 with migraine with aura had strokes while taking 25
8 milligrams rofecoxib daily, aged 17 and 24. I don't
9 know if Vioxx caused their stroke, but none of my
10 patients taking naproxen have had strokes."
11 Q. Thank you.
12 Now, as I understand your testimony
13 from a few minutes ago, you did not know before you
14 answered my questions on March 30th of this year
15 that in point of fact, you should have sent this
16 letter down to the adverse event report department;
17 is that correct?
18 A. I think it's fair to say that is
19 correct. I was not familiar with the exact details
20 of the procedures here.
21 Q. But, in fact, when you got this
22 letter in January 2005, you should have sent it down
23 to the adverse event report department; correct?
24 A. The policy and procedures at Merck
25 for Merck employees are that when any employee

994
1 receives a letter or information about a potential
2 adverse event, that it should be forwarded to the
3 adverse event department.
4 Q. So, that means this letter should
5 have been sent down to the adverse event department
6 in January of 2005; correct?
7 A. Assuming thats when I received
8 that letter, that would have been the policy and
9 procedures to follow.
10 Q. Now, you'd been working at Merck for
11 four years and two months exactly when I asked you
12 about this on March 30th of 2005; correct?
13 A. Correct.
14 Q. You did not know the relevant policy
15 until we discussed the issue on that date and then
16 thereafter when you asked about it; correct?
17 A. I'm sorry, when you said "thereafter
18 when you asked about it" --
19 Q. Well, you did followup by asking your
20 colleague, Dr. Honig, what you should be doing;
21 correct?
22 A. That's correct.
23 Q. Is there a written policy with
24 respect to the obligation of all Merck employees,
25 including the president of Merck Research

995
1 Laboratories, to provide to the adverse event
2 department any report of adverse incidence?
3 A. I'm not sure if there's a written
4 policy. What I am now aware of is that there is a
5 policy and procedures to be followed by all Merck
6 employees when they receive information about a
7 potential adverse event with a Merck product.
8 Q. Well, have you asked if there is a
9 written policy to that effect?
10 A. No. What I've done is to --
11 Q. Sir, my only current question is,
12 have you asked if there is a written policy to that
13 effect? I think that question could be answered yes
14 or no.
15 A. No, I have not.
16 Q. Well, isn't it important for you to
17 know as the president of Merck Research
18 Laboratories, a person who describes himself as
19 being "responsible for the overall patient safety
20 associated with Merck's drugs" -- you did use those
21 words to describe yourself earlier today; correct?
22 A. That is correct.
23 Q. Isn't it important for a person who
24 is "responsible for the overall patient safety
25 associated with Merck's drugs" to know whether

996
1 there's a written policy at Merck requiring Merck
2 employees to provide adverse incidence reports to
3 the adverse event report department?
4 A. I think the important thing for me to
5 know is that such a policy exists and to take steps
6 to ensure that policy is followed. When I was
7 made aware of the policy, I took steps to ensure
8 that not only my staff, but also the administrative
9 assistants of my staff, were aware of these
10 policies.
11 Q. Can you answer my question directly
12 as to whether you believe you should know whether
13 there's a written policy to that effect?
14 A. I don't think it's critical that I
15 know that there's a written policy to that effect.
16 What is important is that I know that there are
17 policies and procedures and that there are people in
18 place to articulate and follow those policies.
19 Q. Putting aside the question of whether
20 you think it important to know whether there is a
21 written policy on this subject, do you think that
22 there should be a written policy informing Merck
23 employees of their obligation to report adverse
24 incidents to the adverse event report department?
25 A. You're asking my opinion?

997
1 Q. Yes.
2 A. Yes. My opinion is yes.
3 Q. Are you going to see to it that such
4 a policy is put in writing if it has not already
5 been done?
6 A. I will investigate whether or not
7 there is such a policy in writing. I assume that
8 there is, but I don't know that there is, which is
9 why I answered the question the way I did.
10 Q. Okay. Thank you.
11 If there is not such a policy in
12 writing, will you see to it that it's put in
13 writing?
14 A. I will take steps to investigate if
15 that's the case.
16 Q. Well, can you answer my question
17 directly, which is, will you see to it that such a
18 policy is put in writing if it has not already been
19 put into writing?
20 A. I think it's fair to say that I would
21 do that, yes.
22 Q. You have that power; correct?
23 A. I have the power to influence that.
24 Q. How many employees does Merck have?
25 A. Approximately 65,000 employees at

998
1 Merck.
2 Q. How many of those 65,000 people do
3 you think, like you, didn't know that there was a
4 policy requiring Merck employees to report adverse
5 incidents to the adverse event report department?
6 MR. KIERNAN: Objection, form.
7 THE WITNESS: I do not know.
8 BY MR. SPECTER:
9 Q. Do you intend to find out?
10 A. I don't intend to find out in that
11 way.
12 Q. Do you intend to find out in some
13 way?
14 A. Well, I think the question is a good
15 question and is one that is worthy of followup.
16 Q. So, do you intend to follow up to the
17 question that I've asked?
18 A. Yes, I think --
19 Q. How?
20 A. -- that that's a good suggestion.
21 Q. How?
22 A. Well, I will begin by discussing it
23 with people like Dr. Honig and others on my staff.
24 In general, I rely on people that are subject matter
25 experts on my staff, and I would not want to

999
1 proscribe, proscriptively say how it is that we
2 should go about doing something, but I do think that
3 the issue is an important issue that I should
4 discuss with members of my staff who are better
5 equipped to address these issues.
6 Q. Does the FDA require drug companies
7 to have a procedure in place for the internal
8 reporting of adverse incidents?
9 A. I'm not familiar with what the
10 explicit FDA requirements are.
11 Q. You don't know; correct?
12 A. I don't know. People on my staff
13 would certainly know the answer to those questions.
14 Q. Dr. Kim, when you discussed this
15 matter further with Dr. Honig, did you see to it
16 that Dr. Snodgrass's letter reporting two strokes in
17 women aged 17 and 24 who were taking Vioxx, did you
18 see to it that this letter found its way down to the
19 adverse event report department?
20 MR. KIERNAN: Objection to form.
21 THE WITNESS: I think I said what I
22 did. I'll restate it.
23 What I did was to instruct my staff
24 to go through my correspondence and to identify any
25 correspondence which highlighted a potential adverse

1000
1 event with a Merck drug and to forward that to Dr.
2 Hostelley. When they did that, this was one of the
3 letters that they found.
4 BY MR. SPECTER:
5 Q. Was there followup by the adverse
6 event report department on these reports?
7 A. I do not know what the adverse event
8 department did following receipt of this letter.
9 Q. Have you asked?
10 A. No, I have not.
11 Q. Does it interest you to know what
12 followup has occurred with respect to a letter that
13 was addressed to you from a physician at the
14 University of California concerning a report of
15 strokes in two young women aged 17 and 24 while on
16 Vioxx?
17 A. It's of interest to me to know that I
18 have highly competent and qualified people who are
19 extremely familiar with the procedures and policies
20 and the FDA requirements to deal with these issues
21 and that they are in place to carry out their
22 functions.
23 Q. My question was whether it interests
24 you to know what followup has occurred with respect
25 to this letter. Do you want to know the answer to

1001
1 that question?
2 A. Specifically, no. I think that,
3 again, I have qualified people who are addressing
4 these issues, and I have confidence in them to do
5 so.
6 Q. Do you have an expectation that they
7 are going to contact Dr. Snodgrass and get the
8 records of these patients?
9 A. I don't have that expectation. I do
10 have the expectation that they will follow
11 procedures and do so in a correct manner that
12 follows the policies and procedures.
13 Q. Do you know what those procedures
14 are?
15 A. No, I do not.
16 Q. Don't you think you ought to know
17 what the procedures are for followup of adverse
18 incident reports?
19 A. I have extreme confidence in the
20 group that is dealing with adverse event reporting
21 at Merck. It's a highly qualified, very
22 professional group, and I have confidence in them,
23 and I have confidence in the leadership that they
24 are doing the correct thing.
25 Q. Dr. Kim, when you asked your staff to

1002
1 pull together these reports that you had received
2 concerning adverse incidents regarding
3 pharmaceuticals, how many such reports did they pull
4 together?
5 MR. KIERNAN: Objection to form.
6 THE WITNESS: I believe that there
7 were two.
8 BY MR. SPECTER:
9 Q. Was this one of them?
10 A. That was one of them.
11 Q. What was the other one?
12 A. I don't recall.
13 Q. Did it regard Vioxx?
14 A. I don't recall.
15 Q. When was that letter received by you?
16 A. I don't recall.
17 Q. Do you know how many letters
18 employees of Merck have received over the five plus
19 years that Vioxx was on the market reporting on
20 adverse incidents that were not, in fact, reported
21 to the adverse event report department because the
22 person who received the letter, like you, didn't
23 know the procedures?
24 MR. KIERNAN: Objection to form.
25 THE WITNESS: No, I do not.

1003
1 BY MR. SPECTER:
2 Q. Have you made any effort to inquire
3 as to that subject?
4 MR. KIERNAN: Objection to form.
5 THE WITNESS: No, I have not.