William Farone - Rebuttal

22 WILLIAM FARONE,

23 called as a rebuttal witness on behalf of the

24 Plaintiffs, being first duly sworn, was examined and

1 testified as follows:

2 DIRECT EXAMINATION

3 BY MR. TILLERY:

4 Q. State your name for the record?

5 A. William Anthony Farone.

6 Q. You were the first witness in this case?

7 A. It's my understanding, yes.

8 Q. All right. Now, you know that there have

9 been some witnesses called by Philip Morris?

10 A. Yes.

11 Q. And you're aware of the fact a man by the

12 name of Houck came in here and testified. You've been

13 told about that, haven't you?

14 A. Mr. Willie Houck, yes.

15 Q. And did you know Willie Houck when you worked

16 at Philip Morris?

17 A. I did.

18 Q. And what was -- just in terms of time frame

19 again, it's clear in the record, but you started at

20 Philip Morris at what time?

21 A. 1976.

22 Q. Now, have you read the portions of Mr.

23 Houck's testimony where he talked about being a

24 designer of the Marlboro Light cigarette?

1 A. Yes, I am.

2 Q. And where he was described as one of the

3 designers of that product?

4 A. Yes.

5 Q. All right. Now, let's walk through that.

6 First of all, generally I'm going to ask you based

7 upon everything you know about all of your experience

8 -- and your experiences at Philip Morris, do you think

9 Willie Houck designed the Marlboro Light?

19 Q. Well, let's just approach it from this

20 standpoint. Do you have information or knowledge you

21 could share with the Court about whether or not with

22 respect to Marlboro Lights, Willie Houck was the man?

23 A. Yes, I can.

24 MR. LOMBARDI: And, your Honor, that is not

1 at all what Mr. Houck said from the witness stand and

2 it's an improper question.

3 THE COURT: Well, he clarified my perception

4 anyway so I won't think of him as the man. Go ahead.

5 Q. All right. Would you share that with the

6 Court?

7 A. The products at Philip Morris are directed by

8 a corporate product committee. And if I could give

9 you an idea, they start at a position like the one Mr.

10 Houck held. Mr. Houck, at the time I went to Philip

11 Morris, reported to a product leader. It was either

12 Paul Gauvin or Warren Claflin who reported to a

13 manager, Mr. Leo Meyer; who reported to a director,

14 Dr. Walter Gannon, was at the level that I was at, who

15 reported to the vice-president of R&D, who reported to

16 the senior vice-president of P.M. USA, who reported to

17 the president of P.M. USA, who reported to the

18 chairman of P.M. USA, who reported to the president of

19 P.M. Incorporated, which is what it was called when I

20 was there. The name was changed. And then there's

21 also a chairman of P.M. Incorporated.

22 Now, the -- associated with the office of the

23 president of P.M. Incorporated, which is above P.M.

24 USA, is an entity called the corporate products

1 committee. And the corporate products committee make

2 all of the decisions, even minor decisions, relative

3 to products sold by Philip Morris, prototypes

4 developed, testing that was accepted.

5 That was the group that met in Richmond. The

6 product committee didn't, but representatives of the

7 product committee would meet as part of the Richmond

8 meetings I described earlier, and at that time the

9 directors and people present at that meeting -- Walt

10 Gannon would be the director involved at the time I

11 went there, would have the opportunity to convince the

12 members of the product committee with regard to

13 suggestions for what products should be made, for

14 example, for a change in Marlboro Lights or for a

15 Cambridge or whatever.

16 But basically Philip Morris is a top down

17 operation. That is the directions came from above.

18 We did have the opportunity to suggest what designs

19 should be used.

20 Q. Now, when you say we --

6 Q. Well, my question to you was when you said we

7 could suggest, when you said that were you talking

8 about a level down, what did you say, four or five

9 tiers below your level at Philip Morris, that we level

10 could suggest, that is where Mr. Houck would be?

11 A. No. Only indirectly. In other words, he

12 could suggest it to Mr. Gauvin or Mr. Claflin would

13 suggest it to Mr. Meyer, but basically those

14 discussions took place and are documented in Richmond

15 minute meetings where it was very, very clear over the

16 period of time I was there and going back to the early

17 '70s, that directions came from the corporate product

18 committee, decisions were made by the corporate

19 product committee, and the influence that R&D have

20 through the directors who attended those meetings was

21 to suggest ways that certain things could be

22 accomplished.

23 Q. Now, when you came there was 1976, the Philip

24 Morris' Marlboro Light was on the market at that time,

1 right?

2 A. That's correct.

3 Q. At the time you came there, was Mr. Houck in

4 such a position, occupying such a position, where he

5 could have been considered the designer or creator of

6 the Marlboro Light when you came there?

2 MR. LOMBARDI: "Q. And after your first year

3 of instruction, were you the person who made the final

4 decision as to the tobacco blend that would go into

5 Marlboro Lights?

6 A. Absolutely not.

7 Q. Were you the person who made the decision or

8 had the responsibility for the decision as to the

9 additives that were put into Marlboro Lights?

10 A. No. That was the Flavor Department.

11 Q. Did you have the final decision as to the

12 specific ventilation percentage for Marlboro Lights

13 filter?

14 A. I wouldn't say me specifically. I believe

15 our Filter Development group did, okay. But it was

16 after we" --

7 Q. He just made a comment on this record that he

8 was one of the three or four people who designed the

9 filter for the Marlboro Light. Okay?

10 A. Yes.

11 Q. Did you hear that?

12 A. I did.

13 Q. All right. What do you -- what would you

14 know about filter design from your review of documents

15 that were there before you came --

16 MR. LOMBARDI: Objection. Foundation.

17 THE COURT: Overruled.

18 A. The design filters as with all specifications

19 for a cigarette was a group or a group project. In

20 other words, there were many, many people involved in

21 determining what specifications ended up going into

22 the final cigarettes that were made into prototypes to

23 be tested to see whether they would be acceptable to

24 the corporate product committee.

1 Q. And you were, I think, going to mention or

2 describe what the corporate product committee was

3 earlier. I think I interrupted you. What is that or

4 was that corporate product committee?

5 A. That committee included the chairman and the

6 president of P.M. Incorporated at that time. Usually

7 the chairman and president of P.M. USA and some senior

8 vice presidents, and they would actually decide what

9 tar levels we should have. We would suggest what

10 filter designs we should use.

11 If you follow the records, you will see they

12 decided the type of perforation, the color of the

13 paper, the exact length of the rods and filters. The

14 corporate product committee at Philip Morris was the

15 deciding body, was the body that suggested what we

16 should work on.

17 Now, Mr. Houck did have a role in the

18 process. Once the specifications were set, he, as I

19 recall, during the time I was there, made sure that

20 the products were produced to be sent out to the

21 consumer test, basis the specifications that had been

22 agreed upon by everybody else.

23 MR. LOMBARDI: And I object and I move to

24 strike. He just implied that he saw, he said while he

1 was at Philip Morris, Mr. -- Dr. Farone was, that he

2 saw what Mr. Houck did on Marlboro Lights which is not

3 true. Dr. Farone was not there at the time.

4 Q. Would that be consistent with Mr. Houck's

5 claim that he was the co-designer of the filter

6 system, sir, your understanding of those documents?

7 THE COURT: Well, wait a minute. We're not

8 past this objection.

9 MR. TILLERY: Oh, I'm sorry.

10 THE COURT: He said -- a statement made he

11 wasn't there at the time --

12 MR. TILLERY: Oh, sure. I qualified that

13 when I asked the question. His knowledge of the

14 internal documents that he reviewed. He spent --

15 MR. LOMBARDI: Which documents, Judge?

16 MR. TILLERY: Your Honor, -- your Honor, if I

17 could finish. In his direct testimony when you called

18 us to the bench, you told me not to go back through

19 all this again.

20 THE COURT: Right.

21 MR. TILLERY: In his direct testimony he

22 indicated to you that he spent the first full year of

23 work there, when he was asked to come there, reviewing

24 from their library, reviewing from all their

1 documents, for the sole purpose of familiarizing

2 himself with everything that had gone on in terms of

3 design.

4 THE COURT: Okay.

5 MR. TILLERY: And I did not go back over

6 that. If the Court wishes, I will.

7 THE COURT: No. In that context you may

8 proceed. Overruled. You may proceed.

9 Q. All right. Did you -- do we have an answer

10 to the question on the record?

11 THE COURT: Not yet.

12 Q. I think it was actually a Motion to Strike so

13 we don't have. Let me ask you another question. All

14 right. If Mr. Houck described his role as the

15 co-designer of the filter system, would that be

16 consistent with, one, your review of those documents

17 and, two, your knowledge of how the system would be

18 designed when you were there?

19 A. It would not.

20 Q. All right. Based upon what you've told us?

21 A. Based on my knowledge of having been there

22 and knowing how things work and extensive discussions

23 on filtration systems including the filtration system

24 of the Marlboro Lights.

1 Q. Okay. Now, you know that a Dr. Carchman came

2 here and testified as well?

3 A. Yes, I do.

4 Q. All right. And was Dr. Carchman a person who

5 was at Philip Morris when you were there, sir?

6 A. No, he was not.

7 Q. He came after you were there, didn't he?

8 A. That is correct.

9 MR. TILLERY: Can I have those documents?

10 Your Honor, at this point I've given Dr. Farone a copy

11 of these same documents, which I think are in

12 evidence, and it will expedite things. They're sort

13 of in sequence, but if we could go through them all at

14 one time. That's what I'm trying to do. He'll

15 identify them.

16 Q. I want to direct your attention to the first

17 document.

18 MR. LOMBARDI: I was just going to ask for

19 the -- I don't have the exhibit number. If you could

20 read the exhibit number.

21 MR. TILLERY: Sure. Absolutely. We'll do

22 that.

23 The first one is defense exhibit 5603. The

24 second is --

1 MR. LOMBARDI: Just as he goes is fine. I

2 just want --

3 MR. TILLERY: I'm sorry?

4 MR. LOMBARDI: You can just do it as you go.

5 MR. TILLERY: All right. Sure. I will.

6 Okay.

7 THE COURT: Where do I see that number? It's

8 obliterated.

9 MR. TILLERY: Yeah, it is -- there are CKT

10 numbers on this document.

11 THE COURT: All right. Go ahead.

12 Q. (By Mr. Tillery) All right. You have the

13 copies there in front of you, Dr. Farone?

14 A. Yes, I do.

15 Q. All right. Now, I want to direct your

16 attention to a particular page of this document which

17 was reviewed and discussed by Dr. Carchman when he

18 came here and testified. Looking specifically at page

19 six of that first document. This is a document

20 entitled Biological Effects of Smoke, written by R.

21 Pages, approved by W. Kuhn. And are you familiar with

22 that one?

23 A. Very much so.

24 Q. Now, down here on the distribution list, the

1 fourth one down on the left, W. A. Farone. Who's

2 that?

3 A. That's me

4 Q. This is a document that was distributed to

5 you that you received and looked at when you were at

6 Philip Morris?

7 A. Yes.

8 Q. All right. Now, I want to direct your

9 attention to page six of that document. And highlight

10 if you would, Jean, that last portion. Right there.

11 You know that Dr. Carchman came in and

12 testified about that highlighted portion of that

13 paragraph where it says there was no significant

14 correlation between the activity shown in Table 3 and

15 the EBA. What's EBA?

16 A. Estimated biological activity.

17 Q. Table 1. Okay. For example, the TA98,

18 what's that?

19 A. That's a strain in the Ames test.

20 Q. Activity versus the EBA, and then it says r

21 equals 0.537. What does that mean?

22 A. Well, the document -- the statement, of

23 course, is true, but what it means is that it's

24 restricted. This is not a general discussion of the

1 Ames test. This is a discussion of the information

2 that is in Table 3, because it's talking about the

3 activities shown in Table 3, and if we go to Table 3 I

4 think I can explain further. That's on --

5 Q. That would be page 42 of that document?

6 A. Correct.

7 Q. All right. By the way, before we leave, if

8 we could, hold that spot right there, Jean.

9 Dr. Carchman testified that the -- this

10 statement as a reference tells him from this study and

11 this report that the Ames test shows no positive

12 correlation with biological activity based upon this

13 study. Do you agree with that?

14 A. No, I don't agree.

15 Q. Can you demonstrate by using the documents

16 which you have before you that that statement is

17 incorrect?

18 A. Yes, I can.

19 Q. And these are internal Philip Morris

20 documents?

21 A. Yes.

22 Q. All right. Why don't you do that for us?

23 A. Okay. Well, first, let's make sure we

24 understand what EBA is.

1 Q. All right.

2 A. If we could go to CKT004980, which I think is

3 page 42 of this report. And this is a table that's

4 referring to -- and if you look at the right-hand side

5 you'll see EBA, and I'll go to another document and

6 explain what that means in a minute.

7 But for the time being I'd like to note the

8 three bottom things that are tested there. Bright

9 plus these three samples. Bright plus 6.7 percent

10 sodium nitrate and these two LTF samples. LTF stands

11 for low tar filler. It's not really tobacco. It's a

12 paper type product. It's a tobacco substitute. And

13 the reason why, as we'll see as we go on here, that

14 this particular statement didn't cause any alarm, no

15 one expected it to correlate.

16 Q. Why not? Why wouldn't you expect there to be

17 a correlation?

18 A. Well, because these three things were known

19 at the time to -- anything with nitrate in it behaves

20 differently in the mouse skin painting test than it

21 does in other biological tests.

22 Q. I'm going to stop you for just a minute, and

23 I -- and I -- if I can. And I want to make sure that

24 the record is clear and everyone here knows what we're

1 all talking about first. We're moving pretty quickly

2 here. Okay. Again, what is the purpose of this Ames

3 test, just generally, and its connection with

4 mutagenicity?

5 A. The Ames test measures mutagenicity. The

6 mouse skin painting test, which is an element of the

7 estimated biological activity as we will see, measures

8 the ability of substances to form tumors on the skin

9 of mice.

10 The mechanism on mice, except for certain

11 instances where you don't get good penetration of the

12 chemicals into the skin cells of the mice, is expected

13 to be related to what happens in humans. The mutation

14 that you see in the microbe is also expected to be

15 related to what happens in humans. So the ultimate

16 arbiter of which one you use has to do with damage in

17 humans, not with mice and bacteria.

18 However, it's useful, the reason for being

19 concerned about this correlation is if there was, for

20 example, in every instance a correlation between the

21 mouse skin painting test and the Ames test, you could

22 stop doing the mouse skin painting test because they

23 would be essentially the same thing and there are some

24 differences. Those differences were known. They

1 persist still today. There are certain materials

2 because of their chemical composition, the nitrates

3 are the example. A good example. Behave differently

4 in the mouse skin painting test than they do in the

5 Ames test especially with microsome activation.

6 The Ames test can be done several different

7 ways. One, it requires activation. That's the one

8 that's generally used. And you'll see later from the

9 documents here that this was well known. And this

10 statement doesn't mean that the Ames test isn't valid.

11 It simply means it doesn't correlate in this table.

12 Q. All right. Now, let's go back if we can --

21 MR. TILLERY: This is a prelude for several

22 points down where we're getting to the final issue.

23 Q. Let me stop you for just a second and ask you

24 again for the record, you said it wasn't a surprise.

1 A. No.

2 Q. All right. Why?

3 A. Well, let's go to the second document.

4 MR. TILLERY: All right. The second document

5 I think is -- again, is another document in evidence,

6 your Honor. This was referenced by Dr. Farone. I

7 think introduced through Dr. Farone, and this is the

8 notes or notes of Robert Seligman.

9 Q. (By Mr. Tillery) By the way, just for the

10 record again, who was Robert Seligman?

11 A. He was the vice president of research and

12 development. My immediate superior and also the

13 immediate superior of Thomas Osdene.

14 Q. And this is a document marked Defendant's

15 3408 I believe. And tell us --

16 MR. LOMBARDI: Plaintiffs I think, isn't it?

17 MR. TILLERY: It is. It's also got a

18 defendant's number on it, but it is a plaintiffs'

19 exhibit.

20 Q. (By Mr. Tillery) Now, what is this

21 document, first of all?

22 A. This document was a summary of the status of

23 biological testing prepared in connection -- on the

24 front page you'll see the Greek delta symbol, and that

1 is project delta which was the precursor of the

2 Accord. This is an early version of nonconventional

3 cigarettes.

4 And at the time this was prepared, this was

5 done at a meeting with Dr. Seligman. He was preparing

6 this to use in explaining to senior executives of

7 Philip Morris, Incorporated what the status was of our

8 knowledge of biological testing. This is 1980. This

9 document occurs two years after the one you just

10 looked at.

11 Q. And were you at that meeting?

12 A. Yes.

13 MR. LOMBARDI: I'm sorry. Where is the date

14 on this document?

15 MR. TILLERY: Well, in his direct testimony,

16 if you recall, Mr. Lombardi, he actually identified

17 being at the meeting.

18 MR. LOMBARDI: I don't remember the date,

19 however.

20 MR. TILLERY: He said 1980 was the time of

21 the meeting.

22 Q. (By Mr. Tillery) Now, Dr. Farone, --

23 A. Yes.

24 Q. -- can you direct us or the Court to the page

1 that you were looking for in that document to further

2 reference the nitrate portion?

3 A. Yes. It's CKT045943. 943 are the last three

4 digits.

5 Q. And what does this highlighted portion

6 indicate?

7 A. This is a description of our understanding

8 and knowledge about the Ames test at that time.

9 Q. And what does it tell you?

21 Q. (By Mr. Tillery) Go ahead.

22 A. What this says and what we knew is that if

23 you have nitrate in the cigarettes, then if you test

24 that in the Ames test, you get the lack of

1 correlation. The nitrate cigarettes produce large

2 effects without microsomes. And they have less effect

3 with microsome dependent activity. So the large

4 effect you see in the mouse skin painting tests, the

5 reduction, you don't see in the Ames test. So this is

6 an explanation. We knew that there were several

7 instances where the correlation would not hold, but

8 generally it was the conclusion at that time and you

9 will see subsequently in time, generally good

10 correlation with skin painting tests.

11 Q. And what other subsequent document are you

12 talking about demonstrating that there's good

13 correlation with the mouse skin painting test?

14 A. If we can skip one and go to number four on

15 the list of what we have here. That's CKT055377.

16 Q. And that is a document to E. B. Sanders from

17 doctor or from T. and then the last name is Y-U dated

18 October 3rd, 1984?

19 A. Yes. Terry Yu.

20 Q. And that's a Philip Morris document?

21 A. Yes, it is.

22 Q. And if you could demonstrate the portions

23 that you're referring to?

24 A. It goes to page nine of that report which is

1 CKT055385.

2 UNIDENTIFIED PERSON: 385?

3 A. 385. That's it. No. It's CKT055385. Let

4 me read the first section up there. The Ames test has

5 a large database. It is capable of detecting the

6 activity of a large variety of test compounds. In

7 fact, it is one of the best validated and most widely

8 used in vitro assays.

9 Q. All right.

10 A. And this was the opinion in 1984 after I left

11 actually, but it was our opinion while I was there,

12 and the test has -- actually it's the test of choice

13 for all of the brands and things that have been tested

14 recently.

15 Q. Does it continue to be that way?

16 A. Yes, it does. And this document on page

17 CKT055382 --

18 MR. LOMBARDI: Could you just give me the

19 number of the document? I have a different numbering

20 system.

21 A. Page six within the document.

22 MR. LOMBARDI: Thank you.

23 A. If you look at the top where it talks about

24 Model III cigarettes, this is the --

1 Q. (By Mr. Tillery) The first paragraph.

2 A. This is a discussion of a test protocol that

3 was performed. Okay. In 1979, which we'll see in a

4 minute where the filter dilution results were obtained

5 showing that there was increased mutagenicity as the

6 dilution and filtration increased, holding everything

7 else the same.

8 Q. And what's the significance of that now?

9 A. Well, this is relative -- this is directly

10 related to the difference between Marlboro Lights and

11 Marlboro. We're getting to in terms of discussing the

12 statistical significance of the increase in

13 mutagenicity. So if we could go back to document

14 three which is CKT055259.

15 MR. TILLERY: Which is -- I have 5604 of

16 yours, Mr. Lombardi.

17 Q. (By Mr. Tillery) Go ahead.

18 A. And I think the easiest way to see this is to

19 go to the bottom page, CKT055266.

20 Q. What does this indicate, sir?

21 A. Well, this is the results of their analysis

22 of having a product -- and we're looking at

23 ventilation changes and you can see that the

24 mutagenicity increases as filter dilution increases.

1 And it's not linear. We don't have to have a straight

2 line in any of these relationships. It just has to be

3 what we would call monotonic meaning that there's no

4 loops and whirls in it. But it can go up

5 exponentially, it can go up logarithmically.

6 And this is a curve line. You see that it

7 starts off relatively slowly as you increase the

8 dilution and you go up to -- when you go up to 60

9 percent, it's almost triple.

10 The Marlboro and Marlboro Lights fall in the

11 low range of that. A difference between say 11

12 percent filter dilution and 25 percent filter

13 dilution. And so the question is, is that difference

14 statistically significant? That's the question. I

15 believe in Dr. Carchman's testimony the implications

16 were well, this isn't very much of a difference.

17 Q. And actually you know that he did an analysis

18 of what was called a Philip Morris brands study?

19 A. That's correct.

20 Q. All right. And do you have a copy there of

21 the analysis that he put up? Let's put up if you can

22 CKT9011361. Number seven, please. Would you put that

23 up on the Elmo, please?

24 Now, is that the document you've seen?

1 A. Yes, it is.

2 Q. And you understand this is a summary. It's a

3 demonstrative that was used during Dr. Carchman's

4 testimony to demonstrate from his view, I suppose, the

5 relationships between Marlboro and Marlboro Light and

6 referencing numerical difference, percent difference

7 using the Philip Morris brands study?

8 A. Yes, I understand.

9 Q. Now, do you have an opinion to a reasonable

10 degree of certainty within your field as to whether or

11 not that methodology -- now, forget the numbers for a

12 moment. Just forget that. The methodology is the

13 correct way of analyzing whether or not there's a

14 statistically significant distinction between these

15 cigarettes in terms of ventilation?

5 Q. (By Mr. Tillery) Do you have an opinion?

6 A. Yes, I do.

7 Q. What's your opinion?

8 A. This cannot be used to demonstrate anything

9 concerning whether or not those products are different

10 because -- I mean it says numerically different. You

11 have to use some sort of statistical analysis to come

12 up with a conclusion as to whether these differences

13 are meaningful in a scientific sense.

14 Q. All right. Before we go on to the analysis

15 that you did yourself, let's just briefly walk through

16 these points that he's making here so you can describe

17 what it is that these numbers demonstrate.

18 A. Well, first of all, this is only a part of

19 the information. These numbers come off data which I

20 think we should show where it came from.

21 Q. Right. We will.

22 A. And then it will become obvious that the

23 numbers that Dr. Carchman used are the numbers from

24 the total particulate matter, TPM, for each of these

1 two dates comparing Marlboro Lights with Marlboro.

2 There's also another set of data, and I've

3 used all the data so that we can lay it all on the

4 table where they correct this for tar because we know

5 that the carcinogens are in the tar, mutagens are in

6 the tar. And so there is another set of numbers that

7 relate to the tar rather than the total particulate

8 matter. If you recall, the total particulate matter

9 is the sum of water plus nicotine plus tar.

10 Q. Right.

11 A. So you can do it either for the total

12 particulate matter, which is what Dr. Carchman did,

13 which gives you lower numbers or you can correct it

14 only for the tar, and it gives you a different set of

15 numbers.

16 Q. Now, did you do this analysis yourself?

17 A. I did.

18 Q. What did you use as your starting point for

19 the analysis?

20 A. There are four pages from the report from

21 which these numbers come and if we could --

22 Q. Let's pull up the first one and that would be

23 CKT9011368. 1368.

24 A. No, it's 58. Go to the next page actually.

1 58 would be.

2 Q. We can show them on the Elmo if they're not

3 coming up on the system. There we go.

4 A. Okay. That's 1368. That one. 1368. This

5 is on a per milligram of tar basis, strain TA98. And

6 if you look at the numbers here you'll see for

7 Marlboro the numbers 4447 on September 5th, 4565 on

8 September 12th, Marlboro Lights 4910. And it also

9 tells you right next to the revertants per milligram

10 of tar, it also tells you what the standard deviation

11 is. Do you see it there? 112 in the case of the

12 first number and 108.

13 Q. Do you mind if we stop for a minute and just

14 make sure the record is clear here. I know that this

15 is all absolutely second nature to you. Okay. But

16 just so we're clear, what do these numbers mean, what

17 kind of a study is this, how did they get here. Just

18 lay the groundwork for this if you would.

19 A. Okay. This is the standard Ames test where

20 we're counting the revertants. That's the number of

21 bacteria that were -- that mutated per milligram of

22 tar in this case. And we'll also do it for TPM, and

23 they do it with replicates. And so when you replicate

24 something three times or more, you can calculate a

1 standard deviation.

2 A standard deviation is a deviation from the

3 adverse that's reported here. And using the standard

4 deviation, one can statistically distinguish between

5 things. If you -- there's complicated ways of doing

6 it, but I mean there's a very simple way.

7 A simple rule is that if something is

8 different by more than two standard deviations, it is

9 significant at 95 percent level roughly. If it's

10 different by three standard deviations, it's

11 significant in a 99 percent level. And those are --

12 Most scientists when they look at data

13 they're interested in seeing how many standard

14 deviations difference are there between the numbers.

15 And the standard deviation is independent of

16 percentages and numerical values. It gives you an

17 actual feel for whether the numbers are statistically

18 different. And so what I've done in all four cases.

19 Q. You took -- you took the analysis from each

20 page that they had?

21 A. I took the data from that page, and I

22 replicated this on another page. Like this data, if

23 we could go to CKT901357.

24 Q. Is that your analysis?

1 A. That's my analysis.

2 Q. All right.

3 A. And all I did was to take the September 5th

4 data for tar, the Marlboro number was 4447, the

5 standard deviation was 1.2. These are exactly the

6 numbers off the previous chart. All four lines here.

7 So in the September 5th data what we do is we

8 take the Marlboro Light score which is 4910. We

9 subtract from it the Marlboro score which is 4447.

10 The difference is 463. That's more than three times

11 the standard deviation of those products.

12 So this is an extremely significant result

13 and approximately the 99 percent confidence level,

14 Marlboro Light is significantly more mutagenic based

15 on these numbers than Marlboro.

16 Q. And was this brands -- this is a brands

17 study. Do you understand that this was done of the --

18 of the cigarettes they would sell on the street?

19 A. Yes.

20 Q. Was that ever done before?

21 A. Not to my knowledge.

22 Q. All the time you were there?

23 A. Correct.

24 Q. All right. Go ahead, sir.

1 A. So the next number from September 12th I did

2 the same thing, and you will see that it's 493.

3 Approximately the same differences. Again, it's

4 significant at the 99 percent confidence level.

5 Q. Now, what's that tell you? I mean you say

6 it's significant to the 99 percent confidence level.

7 What's that tell you as a scientist?

8 A. That tells me that the 1979 study that we did

9 and prior studies would show the dilution increases

10 mutagenicity in the range of 11 to 25 percent that

11 we're talking about for these products is a

12 meaningful, scientifically meaningful difference,

13 higher mutagenicity for the Marlboro Lights.

14 Q. Now, as a designer or a member of the

15 research and development team at Philip Morris, what

16 do these statistically significant results mean in

17 terms of what impact ventilation has on going from

18 here, Marlboro Reds, to here, Marlboro Lights? What's

19 that tell you?

20 A. It tells us that it was not moving in the

21 right direction with regard to mutagenicity. It was

22 the wrong thing. You need to go much further in order

23 to make it be decreased in mutagenicity.

24 Q. Now, did you do more of your analysis?

1 A. I did for all the data --

2 Q. Let's go to the next one.

3 A. The next one is the other strain, TA100,

4 for -- this is -- make sure I've got it right here.

5 I'm looking for where it says under TA100 strain.

6 Q. It's hard to see, but I think it's down here.

7 A. Yeah. TA strain 100. All right. So this is

8 the other strain and this is again the tar, not the

9 TPM, so if we could go to CKT9013 --

10 Q. Before we go forward -- Okay. Before we go

11 forward, please go through for the record for me, --

12 A. Okay.

13 Q. -- tell us what you were looking at are the

14 key numbers. Dr. Farone, I know we're going through

15 it quickly, but I want to make sure the record is

16 complete on this. Okay?

17 A. What I did here again was to take the numbers

18 from Marlboro, which you can see are 1765, the

19 average, on September 5th with a standard deviation of

20 73, 1683 on September 12th with a standard deviation

21 of 106. And then if you go down to Marlboro Lights on

22 September 5th it was 1873 with a standard deviation of

23 96. On September 12th it's 2,062 with a standard

24 deviation of 104. And, again, I put them on a

1 separate chart so that we could perform this

2 comparison.

3 Q. Is that the correct chart number for you?

4 A. This is the correct chart number. The

5 numbers in the box are exactly the numbers that we

6 just read. And, again, what you do is you take the

7 Marlboro Lights and you subtract the Marlboro from it,

8 and you'll see in this case -- and these are the only

9 two cases out of the eight cases I'm going to show you

10 where the difference is only one -- a little more than

11 one standard deviation life. I subtract 1873 from 17

12 -- if I subtract from 1873 1765, it's 108. It's

13 greater than one standard deviation. It's not the two

14 that we would like to see. However, in the September

15 12th case that you see that subtraction yields 379

16 which, again, is more than three standard deviations

17 difference.

18 Q. And, again, what's that mean?

19 A. It means that it's statistically significant.

20 It's a 99 percent confidence level. The other one is

21 directionally the same way. There's no reversion

22 here, but that's not statistically significant at the

23 95 percent confidence level. That would take two

24 standard deviations.

1 Q. And did you do more analysis?

2 A. I did. The next case. The next are for TCPM

3 rather than for tar. These are the numbers that Dr.

4 Carchman had used.

5 Q. Again, for the record, TPM is total

6 particulate matter?

7 A. That is correct.

8 Q. Now, just so we're clear. Where are these

9 documents that you're getting these four data sets

10 from these tests coming from?

11 A. This is from the brands study that was done

12 at INBIFO, a large number of --

13 Q. It says INBIFO and, again, for the record

14 that's the European testing arm for Philip Morris?

15 A. That is correct.

16 Q. All right. Go ahead.

17 A. So here you'll see that we have -- again, the

18 Marlboro numbers are 3485 with a standard deviation of

19 87; 3508, a standard deviation of 83; Marlboro Light

20 3858, a standard deviation of 119; and on September

21 12th, 4061, 119, and I prepared another table for this

22 which is CKT901359.

23 Q. What does this table indicate?

24 A. This table indicates, again, if you subtract

1 the Marlboro Lights and Marlboro numbers, of course

2 the Marlboro Lights are the larger value, from

3 September 5th you get a difference of 373 which again

4 is more than three standard deviations difference. On

5 September 12th you get a standard -- it's a difference

6 of 553, which is more than three standard deviations

7 difference. So for the total particulate matter

8 analysis of strain TA98, that also shows a difference

9 of greater than 99 percent significance.

10 Q. All right. The final set. This is

11 CKT9011367.

12 A. Yes.

13 Q. And what is -- and what is this one?

14 A. This is the final set for total particulate

15 matter with the other tester strain, the TA100 strain.

16 And, again, I used the four values, 1383 with a

17 standard deviation of 57; 1294, a standard deviation

18 of 82. The Marlboro Light I used 1472, a standard

19 deviation of 75; 1656, with a standard deviation of

20 83. And I put those numbers on a separate chart.

21 Q. And this is, just for the record, CKT901360?

22 A. That's correct. And if you do the

23 subtraction again you find in the other case it's only

24 slightly more than one standard deviation. That's the

1 September 5th, but on September 12th it's well over

2 three standard deviations. Again 99 percent

3 confidence.

4 Q. And the -- and the other one in spite of just

5 one standard deviation was still positively correlated

6 with the correct direction?

7 A. That is correct.

8 Q. All right. Now, what does all this tell you?

9 A. Well, it tells us that these things are

10 significantly different and that Marlboro Lights, it

11 isn't just that the numbers are close or you can't

12 make an analysis, the analysis is very clear, and they

13 are significantly different in six out of eight cases

14 to the extent of 99 percent and the other two fall in

15 line. The precision wasn't good enough on September

16 5th which it tests the strain 100. But it's clearly a

17 significant difference in that Marlboro Lights is more

18 mutagenic.

19 Q. And take us back now to all those years

20 before, and do you remember that model that you

21 referenced?

22 A. Yes.

23 Q. That graph?

24 A. Yes.

1 Q. Well, how do these comport with that?

2 A. Well, this is the test that I believe was --

3 that Dr. Carchman referenced when he used the previous

4 graph saying that at some point we -- this isn't

5 enough, you have to go back and do a test to validate

6 that. And this is the test that validates the 1979

7 data using real products out of the market which show

8 a difference between 11 and 25 percent dilution for

9 real products. Just like the other test showed a

10 difference between 11 and 25 percent dilution and it

11 says yes, those differences are meaningful, they're

12 important, they're significant.

13 Q. Were these tests ever done while you were at

14 Philip Morris?

15 A. Not the brand test.

16 Q. And was there the capability of doing it at

17 any time while you were there?

18 A. Yes, there was.

19 Q. Now, I want to refer you to one last exhibit

20 of Dr. Carchman's. And that if you would pull up,

21 Jean, CKT901363. Did you look at that? Have you seen

22 that one before?

23 A. Yes, I have.

24 Q. All right. Just generally, briefly, tell us

1 what it demonstrates here?

2 A. Well, this is, in my opinion, an improper --

3 I mean this -- the title is was there a relationship

4 between ventilation and mutagenicity. And in order to

5 determine that, the only difference in all of the

6 products should be the filter ventilation because

7 there's so many other chemical differences between

8 products that you can't simply look at the filter

9 ventilation as say a property of all products that you

10 have in the test.

11 The Marlboro and Marlboro Lights are the two

12 points on the far left hand side. The bottom is for

13 the strain TA100. The top is for TA98. You can see

14 where it says 3.5 times ten is a third, it's about

15 3500. These are the numbers for TPM.

16 You get a slightly different number if you

17 did it for tar, but if you draw a line between the

18 first two points, do you see that line is headed up.

19 If you draw a line between the second -- the first two

20 points on the other strain that's headed up, that's

21 the flat, straight portion of the curve that we saw in

22 1979. And if you extended that upwards somewhat, you

23 would expect it to go up very sharply except the only

24 thing that's meaningful on this chart are those first

1 two points because they're the only products where

2 everything is the same except the dilution.

3 Q. What are these other dots?

4 A. The other dots are other products that are,

5 you know, Parliament and other things that were in the

6 table that was used to construct that pod. And

7 there's other differences in those, so that can't be

8 used for a study of only ventilation and mutagenicity.

9 Q. And if we're comparing Marlboros and Marlboro

10 Lights where there's been a stipulation that the

11 ingredients, the tobacco content is the same and

12 you're doing a study of ventilation and its effect on

13 mutagenic activity, what's the relevant comparison?

14 A. The only thing you can use is the first two

15 points off of there and you match it up with what we

16 knew in 1979.

17 Q. How do they match?

18 A. A perfect match or it is the evidence that

19 would have shown in 1979 that that curve is exactly

20 correct.

21 Q. What's all this tell you? If you put it

22 altogether as a scientist, as a person who worked

23 there, as a person who spent many years there and

24 knows their design capability, what does all this tell

1 you in terms of ventilation and its effect on

2 mutagenicity? And if you wouldn't mind, I'd like you

3 to do that in the context of Ames testing as well.

4 MR. LOMBARDI: Objection to the form.

5 THE COURT: Overruled.

6 A. What it tells us is the Ames test, that we

7 were using back when I was there, was a good way to

8 measure what happens with mutation. It does correlate

9 with other tests very well. It's probably the most

10 widely recognized test for environmental mutagens that

11 exist in the world today. And that using that on

12 brand new products at the time would have encouraged

13 us to make changes in Marlboro Lights that would not

14 have increased the mutagenicity score. It would have

15 changed these graphs and it requires a different

16 design. The design that was used actually increases

17 the risk of mutation.

18 Q. Mr. Whidby -- Dr. Whidby came here and

19 testified as well, and I want to ask you a couple of

20 questions that relate to his testimony. Do you have

21 an opinion to a reasonable degree of certainty, sir,

22 as to whether or not Philip Morris designed Marlboro

23 Lights and Cambridge Lights cigarettes to deliver less

24 tar and nicotine to smokers than their regular

1 counterparts?

2 A. Yes, I do.

3 Q. What's your opinion?

4 A. To smokers, no.

5 Q. What did they design them to deliver less tar

6 or tar components or smoke constituents to?

7 A. The Federal Trade Commission test. That's

8 what the design parameters were all centered around,

9 the test.

10 MR. TILLERY: Thank you.

11 THE COURT: Cross-examine.

12 MR. TILLERY: Your Honor, I failed to offer

13 these and I'd like to do that in the form if I can,

14 these exhibits as a group exhibit. And the group

15 exhibit would include all of the documents that he

16 referenced plus all of his demonstratives. I'll be

17 happy to do that after Mr. Lombardi finishes his

18 cross.

19 CROSS-EXAMINATION

20 BY MR. LOMBARDI:

21 Q. Good afternoon, Dr. Farone.

22 A. Good afternoon.

23 Q. You weren't there at Philip Morris in 1971,

24 were you?

1 A. I was not.

2 Q. You did not design the filter for Marlboro

3 Lights, did you?

4 A. I did not.

5 Q. You weren't there with Willie Houck to see

6 what Willie Houck did when he was there, did -- were

7 you?

8 A. I was not there in 19 --

9 Q. Actually you weren't there in 1986 when

10 Cambridge Lights were designed either, were you?

11 A. That's correct.

12 Q. Because you had been fired by that time; is

13 that right?

14 A. That's correct.

15 Q. In 1984?

16 A. Correct.

17 Q. And you said that you know based on looking

18 at all these documents, you know what role Willie

19 Houck played in designing the filter for Marlboro

20 Lights. That's what you said; is that right?

21 A. I can prove it.

22 Q. Did you bring a document here today and show

23 it to us in your examination?

24 A. You can't bring a document showing what he

1 didn't do. I can show you documents --

2 Q. There is no document that shows what he did;

3 is that right, Dr. Farone?

4 THE COURT: Well, let's step down with the

5 dramatics and he can ask questions.

6 MR. TILLERY: He should let him answer.

7 That's all I was going to suggest.

8 Q. (By Mr. Lombardi) There is no document that

9 shows what Willie Houck did in 1971 and the years

10 prior to that to design a filter for Marlboro Lights,

11 is there, Dr. Farone?

12 A. I'm not sure of the question. There are

13 documents that indicate how the filter, how the

14 product was designed that don't mention Willie Houck,

15 but I think if you're asking me do I know when Willie

16 Houck was an assistant professional what he did, I

17 don't.

18 Q. Right. Despite what you've testified today,

19 you don't know what Willie Houck did; is that right,

20 Dr. Farone?

21 A. But I do know how the filter system for

22 Marlboro Lights was designed.

23 Q. You do. You do. Well, that's a good

24 question because you just said again, just like you

1 said when you were here before, that Marlboro Lights

2 were in every respect identical to Marlboro regulars

3 except for the ventilation holes. That's what you

4 said before and that's what you said today. Is that

5 right?

6 A. The holes?

7 Q. Right. That's the only difference?

8 A. Not every -- no.

9 Q. That's what you said, isn't that right, Dr.

10 Farone?

11 A. No.

12 Q. Let's start there.

13 A. It is not what I said. If you want to go

14 back and check the record you will find that I said

15 Marlboro Lights and Marlboro have both changed over

16 the years, the tar delivery has changed, the systems

17 have changed. It's very clear what you're, I think,

18 alluding to is the idea that the two things kept pace.

19 In 1971 Marlboro Lights, if I recall, was 12

20 milligrams of tar, Marlboro regular was about 17 or

21 18. We are now talking about cigarettes that deliver

22 15 milligrams of tar and ten respectively. So they

23 change over the years, but the changes have to do with

24 keeping them as close to the same as possible, and the

1 difference between the products all along the way are

2 the dilution percentages.

3 Q. What was the difference -- give me every

4 difference you can recall in as much detail as

5 possible, Dr. Farone, between the 1971 filter on

6 Marlboro Lights and the 1971 filter on Marlboro

7 regulars?

8 A. The 1971 filter?

9 Q. Correct.

10 A. I would have to go back and look at the

11 documents. My recollection is that the differences

12 were predominately -- there was a different total use

13 and a different amount of ventilation. That's the

14 recollection --

15 Q. That is your complete and total recollection

16 of the differences between the filter on Marlboro

17 Lights and Marlboro regulars in 1971, correct?

18 A. As I sit here right now, I don't have any

19 documents.

20 Q. Am I correct?

21 A. Yes. As I sit here.

22 Q. Did you forget, Dr. Farone, that in 1971

23 Marlboro Lights had what was called a dual filter?

24 A. No.

1 Q. Did you forget that?

2 A. No, I didn't forget it.

3 Q. You didn't tell us about it, did you, Dr.

4 Farone?

5 A. What is the point? I agree with you. I

6 didn't talk about it.

7 Q. Well, you just said -- you just said the only

8 difference you knew was the ventilation holes, Doctor.

9 That's what you said to us. In fact, I have that

10 right, don't I?

11 A. The level of dilution is the only significant

12 difference, yes.

13 Q. Well, wouldn't you call a plastic insert to a

14 filter a significant difference between the two

15 cigarettes?

16 A. No.

17 Q. No. Okay. So a plastic filter that affects

18 the RTD and other characteristics was something that

19 you don't consider significant, Dr. Farone?

20 A. From the viewpoint of causing an increase in

21 mutation, the only significant parameter, and I've

22 testified to that, is the percentage of dilution. It

23 doesn't matter how you get there.

24 Q. Actually, Doctor, you didn't say the only

1 significant parameter. You said the only difference

2 was the ventilation holes. That's what you've said

3 about three times just now. You said the only

4 difference was the ventilation holes?

5 A. Do you want to read it?

6 Q. Yeah. Sure. Well, we'll read it later

7 because I want to keep asking you questions. But if

8 your testimony before was that the only difference

9 between Marlboro regulars and Marlboro Lights was the

10 ventilation holes, that testimony was wrong; is that

11 right?

12 A. I'm not sure.

13 Q. Now, what's difficult about that? If your

14 testimony -- if your testimony was that the only

15 difference was the ventilation holes between Marlboro

16 Lights and Marlboro regulars, then that testimony was

17 wrong; is that right?

18 A. If that's the only -- if my testimony was

19 that the only physical difference between was the

20 ventilation holes, my testimony is wrong. I would

21 agree with you.

22 Q. Okay. And we'll let the record stand on

23 that. Now, what exactly did Willie Houck do? I

24 mean -- let me go back. And you got to Philip Morris

1 in 1976; is that right, Doctor?

2 A. That's correct.

3 Q. Now, you got there in 1976, you did all this

4 reading. Tell the Court everything you know about

5 what Willie Houck did with respect to the design of

6 the Marlboro Light filter?

7 A. In 1976?

8 Q. No. In 1971. You testified today that you

9 knew what Willie Houck did.

10 A. Okay.

11 Q. Tell me every detail you know about what

12 Willie Houck did.

13 A. Okay. Willie Houck was very closely aligned

14 to Dr. Cliff Lilly who worked with me and Mr. Warren

15 Claflin, who if you were going to pick anyone who said

16 they designed the filter it would be Warren. And

17 during the period of my tenure at Philip Morris we

18 designed an extremely detailed --

19 Q. Not your tenure. I'm talking about 1971. I

20 want to know what Willie Houck --

21 THE COURT: Wait a minute.

22 MR. LOMBARDI: Well, my question --

23 THE COURT: Wait, wait, wait. This may well

24 be the basis. Let's see what he says and then --

1 MR. LOMBARDI: Okay, Judge.

2 THE COURT: -- you can continue to examine.

3 A. Because where I'm going with this, Mr.

4 Lombardi, is that we educated Mr. Houck in the areas

5 of filter design. Mr. Houck was one of the first

6 people to use the computer assisted design parameters

7 that we set up in 1976. This is in the period between

8 1976 and 1984.

9 So it was very clear when I knew Willie Houck

10 in 1976 that if he knew a lot about filters in 1971,

11 he apparently didn't know as much as what we were

12 helping him understand about how filters work, where

13 to put the holes for counter ventilation.

14 And this is in the reports written by Dr.

15 Lilly and others because Mr. Houck, it turned out was

16 very useful to applied research, my director, because

17 he would accept this new information about filter

18 design and attempt to put them into their products.

19 And during the time I was there, I think about 1980,

20 Mr. Houck was promoted to the position of research

21 scientist, an associate scientist. And to a large

22 extent that promotion was based on our recommendations

23 that Mr. Houck was very helpful in accepting the

24 information that we had developed and moving it into

1 products.

21 Q. (By Mr. Lombardi) Well, let me ask you

22 another question, Dr. Farone. You have said that over

23 the course of time there were changes in Marlboro

24 Lights and Marlboro regulars, correct?

1 A. That's correct.

2 Q. But the only change between the two, the only

3 difference between the two was the ventilation holes,

4 correct?

5 A. The change that we are talking about from the

6 viewpoint of causing mutagenicity, the change that is

7 relevant, is the difference in ventilation percentage

8 or dilution. The other changes such as porous paper

9 and so on, if you keep changing them and then each

10 time in the period, ventilation is the major thing.

11 Q. Well, let me -- did you tell the Court when

12 you were here before under oath, as I said, the only

13 difference between the Marlboro Light and the Marlboro

14 regulars is more dilution holes in the Marlboro Light?

15 A. I could have said that, yes.

16 Q. Let me just show you.

17 A. No.

18 Q. I don't want there to be any confusion,

19 Doctor.

20 A. Okay.

21 MR. TILLERY: Well, he's not disagreeing with

22 you.

23 A. I'm not disagreeing.

24 THE COURT: I think he's trying to emphasize

100

1 a point, but that's all right.

2 A. I agree with you.

3 Q. (By Mr. Lombardi) The only difference

4 between a Marlboro Light and a Marlboro regular,

5 there's more dilution holes in a Marlboro Light.

6 There was no caveat there, Dr. Farone, was there?

7 A. Well, we have to go up and read --

8 Q. No, no. Wait, wait. It says redirect

9 examination. This is Mr. Tillery. His first question

10 out of the box. His first question out of the box.

11 Did you put all those design features of the Marlboro

12 Lights? As I said the only difference between the

13 Marlboro Light and the Marlboro regular there's more

14 dilution holes in the Marlboro Light. That's what you

15 said.

16 A. Okay.

17 Q. Under oath.

18 A. All right.

19 Q. To this Court.

20 A. All right.

21 Q. And you're changing your testimony now,

22 aren't you?

23 A. No. If you go back and read the entire

24 record, I am positive that I explained that those

101

1 products changed over time.

2 Q. Did Mr. Tillery ask you an unfair question?

3 A. No.

4 Q. Is there something about this that's

5 confusing to you now, Dr. Farone?

6 A. Nothing about it is confusing other than the

7 fact that in order to understand the context of the

8 answer, you have to read all that came before it

9 including the entire direct testimony.

10 Q. The-- context this is not enough context for

11 you, Dr. Farone?

12 A. No.

13 Q. Okay. Okay. Now, Dr. Farone, tell me the

14 other changes that you're aware of between Marlboro

15 Lights and Marlboro regulars over time?

16 A. There are so many of them, Mr. Lombardi, that

17 I couldn't possibly remember them all. Every one of

18 them was --

19 Q. There's so many --

20 MR. LOMBARDI: I'm sorry. I apologize,

21 Judge.

22 Q. (By Mr. Lombardi) I apologize. Go ahead,

23 Dr. Farone.

24 A. There are so many of them that occur. They

102

1 change the blends. I think I went into this in great

2 detail. Every year three or four times a year because

3 the crops are different. Okay.

4 THE COURT: What are different?

5 A. The crops. In other words, when you grow --

6 when you use tobacco, to make a cigarette this year

7 you use tobacco from 2002, 2001, 2000, 1999. If you

8 make it next year you ran out of 1998 tobacco.

9 Q. Okay. The blend. We've got the blend. What

10 else?

11 A. The blends. The flavoring systems change

12 over time because we took out --

13 Q. May I just interrupt. Just to make sure, I

14 don't want the way they -- I want the way they changed

15 so that Marlboro Lights was different from Marlboro

16 regulars. If I didn't make that clear, I'm sorry.

17 That's my fault, Judge.

18 THE COURT: See, he's talking about these

19 developments, and as I understand it that's a

20 constant. I mean if it's not, you know, you opened it

21 up.

22 MR. LOMBARDI: That was my mistake if I asked

23 it that way. Let me rephrase it.

24 THE COURT: I thought you had asked it but I

103

1 might be wrong.

2 MR. LOMBARDI: I could have made a mistake,

3 Judge.

4 THE COURT: All right. Go ahead.

5 Q. (By Mr. Lombardi) So it's clear, Dr. Farone,

6 how did they change over time so that Marlboro lights

7 was different than Marlboro regulars?

8 A. Well, we talked about these changes, and I'm

9 virtually positive. We can go back and check the

10 record, but I testified before that they don't occur

11 in the same time. In other words, you might make the

12 change in Marlboro in January and you don't make it in

13 Marlboro Lights until October.

14 So for a small period of time you're going to

15 have different blends, you're going to have a

16 different flavor system, different ratios between DL

17 and RL.

18 So to go through all of those changes you

19 would have to have the complete records of when every

20 brand formulation modification was made between those

21 two products.

22 Now, whenever you make a brand modification,

23 like I put in Marlboro or I change from RCD or BL to

24 RL, you have to change the paper porosity. You may

104

1 have to change the dilution a little bit because the

2 thing that you're trying to do is to keep the tar and

3 nicotine measured by the Federal Trade Commission test

4 the same. And since you do not make the changes in

5 Marlboro Lights and Marlboro at exactly the same time

6 and exactly the same dates, there are differences that

7 occur continuously. For the purposes of discussing

8 toxicity and mutagenicity, dilution is the difference

9 between these products.

10 Q. No, and I'm just -- I'm just asking you

11 questions, Dr. Farone. Let me ask you something more

12 specific. Okay?

13 A. Okay.

14 Q. Were the RTDs, the resistance to draw, of

15 Marlboro Lights and Marlboro regulars different over

16 time?

17 A. I would have to go back and look at the CI

18 reports. I don't recall.

19 Q. And the CI report, this is a cigarette

20 intelligence report; is that right? Or information?

21 A. Cigarette information.

22 Q. And it contains information on various

23 specifications and parameters of a cigarette; is that

24 right?

105

1 A. Of Philip Morris and competitive brands, yes.

2 They're all analyzed and measured, and it was kept

3 track of on an annual basis, and we also had reports

4 that would detail whenever a change was made.

5 Q. Okay. And you did not look at the CI reports

6 before coming in and saying that the only difference

7 between the Marlboro Light and the Marlboro regular is

8 more dilution holes in the Marlboro Light, did you?

9 A. That is correct.

10 Q. Okay. And you haven't looked at it before

11 coming in here today to testify?

12 A. Well, I have actually, but not with that

13 purpose in mind.

14 Q. Okay. Did you look at it to find out the

15 difference in RTD between Marlboro Lights and Marlboro

16 regulars?

17 A. I did not.

18 Q. Let me show you 250.5. This was a chart that

19 was used with Mr. Houck. Did you have a chance to

20 look at this before coming here today?

21 A. I don't think I saw this.

11 Q. (By Mr. Lombardi) Dr. Farone, did you have a

12 chance to look at this chart before coming here today?

13 A. No, but I've seen almost everything on this

14 chart.

15 Q. And so you would agree that another

16 difference between Marlboro Lights and Marlboro

17 regulars say in 1972 was the total RTD? Do you see

18 that?

19 A. Well, yes. The total RTD is different. I

20 agree.

21 Q. And RTD is resistance to draw; is that right?

22 A. That is correct.

23 Q. And resistance to draw in lay person's terms

24 measures how hard you have to suck to draw on the

108

1 cigarette; is that right?

2 A. That's correct.

3 Q. And the measurement, the higher the

4 measurement, the harder it is to suck on the

5 cigarette; is that right?

6 A. That is right.

7 Q. So were you aware, were you aware before you

8 came here today that the total RTD of Marlboro

9 exceeded that of Marlboro Lights in 1972?

10 A. Yes.

11 Q. Okay. And were you aware that the filter

12 length of Marlboro Lights was greater than that of

13 Marlboro in 1972?

14 A. I didn't recall it, but I've had access to

15 all this information which if it was relevant to the

16 mutagenicity, okay, it would have been discussed at

17 all.

18 Q. Well, you were aware that the filter weight

19 of Marlboro Lights was greater than that of Marlboro;

20 is that right?

21 A. I'm aware that all of these differences that

22 you are talking about which do not relate to what I

23 was talking about, but they are differences. And,

24 yes, I see them all and I was aware of them at the

109

1 time I was there. And I don't think you'll ever find

2 any set of cigarettes that any company makes that

3 don't change as you go along to accommodate

4 differences in blends and differences in the things

5 you're doing.

6 Q. Not my point, Doctor. I'm just going off of

7 what you said. You're the one that said, you chose

8 the language in response to a question from Mr.

9 Tillery, you said the only difference was the

10 ventilation holes. Would you agree with me that the

11 tobacco weight is different in 1972?

12 A. I agree with you.

13 Q. Okay. Would you agree with me that all of

14 those parameters were also different in 1990?

15 A. Yeah.

16 Q. And would you agree with me that actually the

17 total RTD of Marlboro Lights was greater than that of

18 Marlboro regulars in 1990?

19 A. Yes.

20 Q. Okay. When did that happen by the way? You

21 were at -- well, just let me ask you. In 1976 to 1984

22 when you were at Philip Morris, were you part of the

23 cigarette design team?

24 A. There was no cigarette design team.

110

1 Q. Were you part of the group that worked on

2 cigarette designs?

3 A. I was part -- I was the director, and I

4 suggested changes to cigarette designs, yes.

5 Q. And were you aware of design changes that

6 occurred in cigarettes?

7 A. They were all discussed at Richmond meetings

8 and had to be approved by the products units. And

9 yes, I was aware of every one.

10 Q. Were you aware of any change in RTD of

11 Marlboro Lights during the time you were there?

12 A. Yes. It changed probably at least once a

13 year, maybe twice a year.

14 Q. Were you --

15 A. Sometimes three times a year.

16 Q. Were you aware during your time at Philip

17 Morris of any time when the RTD from Marlboro exceeded

18 that of Marlboro Lights?

19 A. I would have to go back and look at the

20 records.

21 Q. You don't remember that now?

22 A. I don't remember from 1976 to '84 what all

23 the RTDS were for every year's product or every time

24 they changed the filler and they changed the blend and

111

1 all the changes they made.

2 Q. Do you remember whether during your time at

3 Philip Morris, the RTD of Marlboro Lights became

4 higher than the RTD of Marlboro?

5 A. I remember it being discussed. I do. I

6 don't remember the exact year.

7 Q. Do you remember that it happened during your

8 time at the company?

9 A. I believe that's true because in 1980 when we

10 were discussing the Cambridge cigarette, the original

11 Cambridge was 0.0. The whole issue of RTDs in

12 products became very, very important.

13 Q. Okay. Let me ask you, I want to ask you a

14 little bit about the mutagenicity things you talked

15 about, Dr. Farone. Now, let's go back to your time at

16 the company, that '76 to '84, correct?

17 A. Correct.

18 Q. Did you do any mutagenicity tests between

19 1976 and 1984?

20 A. I suggested them. They were done by

21 apparently other people in the chemical research team.

22 Q. Did you do any mutagenicity tests?

23 A. Personally, no.

24 Q. Did you write any reports of mutagenicity

112

1 tests?

2 A. No.

3 Q. Did you write any memos that talked about the

4 results of mutagenicity tests?

5 A. I may have. I don't recall any as I sit here

6 but --

7 Q. Were mutagenicity tests done under your

8 division at Philip Morris?

9 A. My directive?

10 Q. I apologize.

11 A. Yeah.

12 Q. Under your directive?

13 A. No. They were under Dr. Osdene's.

14 Q. Is it true that you had no direct supervisory

15 role for the mutagenicity testing that was done at

16 Philip Morris during your time there?

17 A. That's correct. I could only suggest what

18 they would do which they did follow.

19 Q. And do you have any notes or memos or

20 anything in writing that shows that you made some

21 suggestion for mutagenicity tests while you were at

22 Philip Morris?

23 A. I do. I think it's in -- it may be in this

24 report.

113

1 Q. Are you referring to one that shows you as

2 getting copied?

3 A. No. I am talking about a specific

4 acknowledgment of my role suggesting the analysis of

5 mutagenicity of sugar to see whether the acetaldehyde

6 caused an increase from burning sugar. And I believe

7 it's in the '78 or '79 reports. 6906 project

8 specifically references with thanks to me saying that

9 they looked at this and, in fact, the Japanese had

10 published a text saying if you add sugar you make it

11 safer. On the basis of what Dr. Osdene and I had

12 discussed about the acetaldehyde being carcinogenic,

13 we doubted that. So we ran the test and found out it

14 does not make it safer. That's the same report that

15 shows that acetaldehyde be a direct positive test. I

16 can find that.

17 Q. That's fine, Doctor. Are you trying to

18 convey that you were centrally involved in the

19 mutagenicity testing that went on at Philip Morris

20 between 1976 and 1984?

21 A. Yes.

22 Q. And you were aware of all the results that

23 you got on mutagenicity or that Philip Morris got on

24 mutagenicity testing between 1976 and 1984?

114

1 A. All of them, no.

2 Q. Most of them?

3 A. All the ones that were reported officially

4 through the channels at R&D, in vitro channels. The

5 ones that were done in vivo, that were sent to Dr.

6 Osdene to be destroyed, of course, I never saw those.

7 Q. Well, let me ask you about the ones you

8 showed in court. I assume that you had personal

9 knowledge of the mutagenicity testing that you've

10 chosen to talk about in court today; is that right?

11 A. I don't have personal knowledge. I got a

12 copy of the report, and I studied it.

13 Q. That's it. Okay. That you knew -- I only

14 mean to convey that you knew about that at the time at

15 Philip Morris?

16 A. That's correct.

17 Q. Okay. Between 1976 and 1984?

18 A. Right.

19 Q. Okay. Now, let's talk about some of the

20 documents that you put up today. This one, the one

21 with the Seligman note. I didn't get your exhibit

22 number on that so --

23 MR. TILLERY: That one is 157-B, Mr.

24 Lombardi.

115

1 Q. (By Mr. Lombardi) Do you know which one

2 we're talking about, Dr. Farone?

3 A. Yes, I know which one it is.

4 Q. And then you also had this other one. I

5 think it's Plaintiffs' 20-L, the May 4th, 1978 annual

6 report?

7 A. Yes.

8 Q. Okay. If you could just get those out for

9 me, please.

10 A. I've got them.

11 Q. And these were documents that you talked

12 about on your direct concerning the correlation

13 between EBA, estimated biological activity and

14 mutagenicity test results; is that right?

15 A. That's correct. Well, no, I'm not sure. I

16 think I may have talked about the correlation between

17 mouse skin painting and mutagenicity testing, not EBA.

18 But they're two different things.

19 Q. Now, you made a very special point with this

20 Seligman document of saying it was from 1980. Do you

21 remember that?

22 A. I believe that's the case.

23 Q. Okay. Well, tell me where in the document it

24 says that it's from 1980?

116

1 A. Okay. Hang on. I don't know whether or not

2 the term 1980 occurs.

3 Q. All I can go on is what you brought to court,

4 Dr. Farone. Find me where it says 1980.

5 A. Hang on. I don't know if it's in here. I

6 don't see any reference in this.

7 Q. And actually, you know, I thought it was with

8 you, but I'm going to say maybe it was with another

9 witness, Dr. Farone, so I'm not misleading you.

10 Counsel for plaintiffs pointed out, say the page with

11 the Bates number 135428. I don't know. Can you find

12 that?

13 A. Yes, I can find it.

14 Q. Pointed out specifically and I'm going to

15 assume it wasn't you, Dr. Farone, but pointed out that

16 the time line there ended in 1977.

17 A. That is correct.

18 Q. And then the next page. There's some more

19 time line, isn't there?

20 A. Yes.

21 Q. That ends in 1977?

22 A. It does.

23 Q. Okay. And it was -- actually there's nothing

24 in this document that indicates that it was written in

117

1 1980, is there, Dr. Farone?

2 A. No. That was my recollection of the time at

3 which the project delta update was discussed, because

4 I was present at the meeting and I could be wrong.

5 Q. I just want to make sure I'm clear. You're

6 saying that you remember now in the year 2003 that a

7 meeting on project delta took place in 1980? Is that

8 your testimony?

9 A. That's my best recollection it was around

10 1980. Of course, 1980 is halfway between 1976 and

11 1984, but I have on the copy that I have on my

12 reliance test says 1980 and where I got that from I

13 don't know.

14 Q. Okay. So you could be wrong about the date

15 of this, Doctor; is that right?

16 A. I could be.

17 Q. Okay. And actually, I wanted to show you

18 something. Let's go to 241 --

19 THE COURT: Isn't that in evidence?

20 MR. LOMBARDI: This is. It's a plaintiffs'

21 exhibit.

22 THE COURT: And as I recall I think I raised

23 the question of the date of the document.

24 MR. LOMBARDI: And you came up, I think it

118

1 was with Dr. Shields and plaintiffs' counsel went

2 through and pointed out that the most recent date in

3 the document I believe was 1977.

4 Q. (By Mr. Lombardi) This was a page you looked

5 at, Dr. Farone? And go ahead and blow that up for me.

6 A. Yeah, I've read the whole document.

7 Q. Okay. And that specifically, I know you go

8 on farther there, but that is the area where we're

9 talking about the mouse skin painting and the

10 correlation?

11 A. Yes.

12 Q. Now, you didn't point out to the Court the

13 part at the bottom of the page, did you?

14 A. I did earlier. I think we discussed that.

15 Q. Actually I don't think you did so let's do it

16 right now. And that says, "Filter, dilution systems,

17 paper, reconstituted tobacco, and some additives which

18 are effective in lowering the delivery of TPM and/or

19 gas face components are effective in reducing activity

20 on a per cigarette basis, although they may have no

21 effect on a per gram of condensate basis." Do you see

22 that, Dr. Farone?

23 A. Not only do I see it, that was the subject of

24 extremely significant discussions with Dr. Osdene,

119

1 yes.

2 Q. And that was what Philip Morris believed

3 in-house at the time that this document was written,

4 isn't that right?

5 A. No.

6 Q. Well, let me just ask you. This is false?

7 A. No. The whole issue is here on a per

8 cigarette basis when you use FTC numbers or whether

9 you use compensation numbers to calculate the per

10 cigarette basis.

11 Q. Well, how do I know, Dr. Farone, when this

12 document is accurate and when it's not accurate?

13 A. I didn't say it was false. I'm explaining

14 the words.

15 Q. Well, no. It says it may have no effect on a

16 per gram of condensate basis, doesn't it?

17 A. It says it may have no effect --

18 Q. And I asked you is that an accurate statement

19 of Philip Morris' knowledge at that time and you said

20 no. Is that right?

21 A. That's right.

22 Q. How do I know when this document is accurate

23 and when it's not?

24 A. It says may have no effect because they

120

1 haven't checked. What they're talking about here is

2 commercial cigarettes. If you look at the 6906 report

3 of which there are several which you can refer to,

4 they show clearly differences between cigarettes on a

5 per gram of condensate. Do you realize --

24 A. Well, it goes to the whole document, but the

121

1 point I was going to make is that we all know from

2 data --

3 THE COURT: Well, do you want it page by page

4 or how do you want it?

5 MR. LOMBARDI: No. I want to know how is it

6 that we are to know whether it's accurate or not? I

7 don't need him to go through the whole document to

8 tell me that, Judge.

9 A. Okay. You take each statement in here and

10 you check it against the data that is already in

11 evidence. For example, on a per gram of condensate

12 basis you know that the revertants per milligram, per

13 gram vary all over the place. So you know that that

14 statement doesn't relate to the general knowledge.

15 What that statement relates to are differences between

16 branded products which supposedly have never been

17 tested.

18 Q. Is that your answer, Doctor?

19 A. Yes.

20 Q. Okay. Thank you, Doctor. And it was

21 important to you to have this document be dated 1980

22 because that would make this document, the May 4th

23 1978 document, precede that one, isn't that right?

24 A. Totally unimportant. Unless you are saying

122

1 that Philip Morris deliberately uses an invalid method

2 in the year 2000 for testing their brands of

3 cigarettes. Is that the only test method they ever

4 used to test brands? No. My issue here is simply

5 that the '84 document is dated, and to this day Philip

6 Morris uses this test exclusively to test the brand

7 new products.

8 Q. Very good, Doctor. My question had to do

9 with the May 4th 1978 document. And do you remember

10 testifying that this document was when they weren't

11 sure about correlation, but then this document

12 followed it and confirmed correlation? Do you

13 remember saying that, Dr. Farone?

14 A. No, I never said that they never were sure.

15 What I said was that that statement about correlation

16 in that document is absolutely true. That .53 between

17 estimated biological activity in that table, but it

18 only relates to that table. Before that document is

19 written and in every case that you find afterwards,

20 the Ames test is accepted by Philip Morris as the

21 validated test for mutagenicity. It doesn't have the

22 nitrate effect where nitrates are known to case harm

23 to man. Okay. It's more accurate than the mouse skin

24 test.

123

1 Q. Dr. Farone, other than this handwritten

2 document and the May 4th, 1978 document that you

3 talked about today, is there any other document that

4 says that mutagenicity testing correlates to mouse

5 skin painting testing at Philip Morris?

6 A. Yes.

7 Q. Which one did you bring?

8 A. I didn't bring it.

9 Q. Oh, you didn't bring it. Okay. Well, then,

10 let's just talk about the ones you brought. You

11 brought the handwritten document?

1 A. I'm rebutting the ones that Mr. Carchman

2 used.

23 Q. (By Mr. Lombardi) The documents that you

24 brought with you to show us in court today are the

125

1 handwritten document that's on the screen and

2 Plaintiffs' Exhibit 20-L; is that right, Dr. Farone?

3 A. Yes.

4 Q. And Exhibit 20-L is one you didn't show us

5 when you were here before; is that right?

6 A. 20-L. Which one is that? I'm sorry.

7 Q. That's the May 4th, 1978 document. The May

8 4th, 1978, Biological Effects of Smoke, annual report?

9 A. I thought I did actually. I thought I had

10 all of those in my reliance set. All of the 6906

11 reports including this one.

12 Q. But does it -- there's a difference between a

13 reliance set and what you talk about in court. Do you

14 understand that, Dr. Farone?

15 A. Attorneys pick the ones that they want to

16 question you about.

17 Q. Right. So those are the two documents that

18 in your view that you brought today that show the

19 correlation between mouse skin --

20 THE COURT: I think that's about the tenth

21 time you asked that. Let's get going here.

22 Q. (By Mr. Lombardi) Let's look at the

23 document, Dr. Farone. October 3rd, 1984. I don't

24 know. I didn't get an exhibit number from counsel on

126

1 that one.

2 MR. TILLERY: I will tell you.

3 A. Okay.

4 MR. TILLERY: That is 157-D, Mr. Lombardi.

5 MR. LOMBARDI: 157 what?

6 MR. TILLERY: D.

7 Q. (By Mr. Lombardi) D. There was some

8 information on correlation in that exhibit; is that

9 right, Dr. Farone?

10 A. This has many -- this is a summary as of 1980

11 -- of October 3rd, 1984 of all of the different

12 testing that has been done.

13 Q. Okay.

14 A. It gives you an independent validation of the

15 Ames test as being something that Philip Morris

16 believed in at that time and still apparently does

17 today as being the best validated and most widely used

18 in vitros.

19 Q. And, Dr. Farone, this was a document that was

20 written after you left Philip Morris?

21 A. That's correct.

22 Q. And you didn't see it until you started

23 working on litigation against Philip Morris?

24 A. That's probably correct.

127

1 Q. Okay. Let's look at -- okay. I'll just --

2 Dr. Farone, I'm going to go to the second page of the

3 document.

4 A. Mr. Lombardi, I just noticed something here

5 with regard to this 1978 report. I think --

6 Q. Dr. Farone, I'm done with this. Let's go to

7 this.

8 A. Okay.

9 Q. This is talking --this is the second page of

10 the document right, Dr. Farone?

11 A. Right.

12 Q. And it's talking generally about what the

13 biological activity research program had been at

14 Philip Morris?

15 A. That's correct.

16 Q. And it says the overall objective was to

17 develop and to utilize a battery of short-term in

18 vitro bio assays which can assess the biological

19 activity, excuse me, of CSTs, right? And CST is what?

20 A. Cigarette smoke condensate.

21 Q. We've seen WSC, that's whole smoke

22 condensate; is that right?

23 A. That's right, but how you collect it relates

24 to how it measures in these tests. So there's plenty

128

1 of information in the data that I have here, but they

2 all give you different results.

3 THE COURT: Just answer the question.

4 A. Okay.

5 Q. (By Mr. Lombardi) And then it goes on to say

6 that the bioassays would be used as tools to

7 investigate the mechanism of CST activity. Do you see

8 that?

9 A. Yes.

10 Q. And the findings will be used to divide the

11 appropriate measures to control and/or to modify CST

12 activity. Do you see that?

13 A. Yes.

14 Q. Then it says in addition to these objectives,

15 it was also hoped that these short term in vitro

16 assays may prove to have predictive values for EBA.

17 That's estimated biological activity, correct?

18 A. Yes. That's correct.

19 Q. And then it says unfortunately the available

20 data show little or no such relationship; is that

21 right.

22 A. That is correct.

23 Q. And you didn't show this part of the document

24 to the Judge just a few minutes ago when you were

129

1 talking about it; is that right?

2 A. I did not.

3 Q. Dr. Farone, have you since you -- well, let

4 me ask you this, Dr. Farone, you were there from 1976

5 to 1984 meaning at Philip Morris?

6 A. Yes.

7 Q. And so you were aware of this what you call

8 this rise in mutagenicity with increasing ventilation;

9 is that right?

10 A. I was.

11 Q. And you were aware, according to your

12 testimony then, that cigarettes with higher

13 ventilation up to a certain point would be more

14 mutagenic; is that right?

15 A. That's correct.

16 Q. And you continued working there at Philip

17 Morris; is that right?

18 A. That's correct.

19 Q. And then you left Philip Morris?

20 A. Yes. But in the interim I -- you know, we

21 were involved in increasing the dilution up from 70 to

22 99 percent. So we did, in fact, develop and put on

23 the market cigarettes while I worked there that

24 overcame that particular problem.

130

1 Q. Well, but while you were there, Dr. Farone,

2 while you were there, you knew about this -- this

3 situation that you've described with ventilation

4 causing an increase in mutagenicity; is that right?

5 A. That is correct.

6 Q. You knew about it as early as, what, 1977 or

7 so; is that right?

8 A. Yes. It's mentioned in the first report that

9 I used in my direct and then again in this '79 report,

10 so I think it's about '77, '78.

11 Q. And you then continued to work at Philip

12 Morris from 1977 or '78 through 1984; is that right?

13 A. That's correct.

14 Q. And one of the things you worked on when you

15 were at Philip Morris during that time period was

16 ventilation?

17 A. Was getting it past this point, yes.

18 Q. No, you worked on ventilation holes

19 specifically, right, Dr. Farone?

20 A. That is correct.

21 Q. And you thought that work on ventilation

22 holes was a good thing?

23 A. I did.

24 Q. You said that over and over in litigation,

131

1 you were proud of the work you did on ventilation

2 holes?

3 A. That's true.

4 Q. You were proud of the fact that Philip Morris

5 had devised an efficient way to make ventilation

6 holes?

7 A. Yes.

8 Q. And you directed people like Jerry Whidby to

9 work on ventilation holes while you were there?

10 A. Jerry Whidby? Jerry Whidby had nothing to do

11 with ventilation holes.

12 Q. Okay. You directed people at your

13 directorate to work on ventilation holes?

14 A. Yeah. Namely, Cliff Lilly and Joe Ennus and

15 Peter Martin.

16 Q. And you thought they did good work with

17 respect to ventilation holes?

18 A. I did.

19 Q. Knowing all the while as you've said, at

20 least as you said here today, that those ventilation

21 holes were causing an increase in mutagenicity,

22 correct?

23 A. A low number of use of those holes could

24 cause an increase in mutagenicity. Yes, we knew that.

132

1 Q. And you knew that. And so then you leave

2 Philip Morris in 1984; is that right?

3 A. That's correct.

4 Q. And when you got outside of Philip Morris,

5 did you go listen, world, these ventilation holes

6 they're increasing mutagenicity, you shouldn't use

7 those cigarettes? Did you do that, Dr. Farone,.

8 A. In 1984?

9 Q. We'll start there.

10 A. No.

11 Q. Did you do it in 1985, Dr. Farone?

12 A. Not after Philip Morris threatened to sue me.

13 Q. Philip Morris has never sued you, Dr. Farone?

14 A. They threatened to sue me.

15 Q. They've never sued you, Dr. Farone?

16 A. They have not.

17 Q. 1990 had you gone out and told everybody,

18 told the world about the public health danger of a

19 more mutagenic cigarette?

20 A. No, I was not involved until 1993.

21 Q. And 1993 is the first time you got involved

22 in -- was that the FDA stuff, Dr. Farone?

23 A. Yes.

24 Q. And in 1993 at the FDA, you didn't start

133

1 talking about mutagenicity being more dangerous in

2 1993, Dr. Farone.

3 A. I believe I did.

4 Q. Actually you didn't, Dr. Farone. It's not in

5 any of your affidavits that you submitted to the FDA,

6 is it?

7 A. You don't know what I talked to the FDA

8 about. I do. The affidavits were only the part that

9 they were interested in.

10 Q. Oh, okay. They weren't interested in the

11 fact that mutagenicity makes cigarettes more dangerous

12 in your view; is that right?

13 A. They were interested in regulating nicotine

14 delivery devices, not in whether or not the design

15 changes may change the mutagenicity of it.

16 Q. Well, can we agree, Doctor, that the FDA is

17 concerned with whether a product is dangerous or not?

18 Can we agree with that? On that?

19 A. Maybe not. Maybe not. I don't know. They

20 have regulatory authority over it. I guess -- I mean

21 I think they should -- it should be, but apparently

22 they can't regulate it so.

23 Q. And, Dr. Farone, you've been talking in

24 litigation against the tobacco companies since what,

134

1 1996?

2 A. That's right.

3 Q. And the first time you have ever said that

4 Marlboro Lights are more dangerous than Marlboro

5 regulars was right here in this courtroom, isn't that

6 right?

7 A. The data --

8 Q. No. Did you hear my question?

9 A. Yeah. Okay. The answer is I don't know if

10 this is correct.

11 Q. It's your answer.

12 A. My answer is no.

13 Q. You did it before?

14 A. Yes.

15 Q. Okay. Well, the record will reflect whatever

16 you said when you were here before. I'm not going to

17 take the time to go back to that, Dr. Farone. But

18 that was the first time you came out and told the

19 public in this courtroom that Marlboro Lights were

20 actually more mutagenic and, therefore, more dangerous

21 than Marlboro regulars; is that right?

7 Q. (By Mr. Lombardi) Dr. Farone, let me just

8 ask you -- let's go to the brands study and the

9 testimony you gave about the brands study. Do you

10 recall that?

11 A. Yes.

12 Q. And you had done some new calculations

13 relating to the brands study; is that right?

14 A. Well, I don't know if you would call it that.

15 All I did was to show the calculations that were in

16 the tables that were in the brands study and just

17 indicate what they meant.

18 Q. And I didn't mean to imply. I just wanted to

19 refer us back to -- you talked about statistical -- I

20 mean standard deviations; is that right?

21 A. Yes. They were mentioned in the brands

22 study.

23 Q. And I think Mr. Tillery pointed out in one of

24 his questions that in the charts that you used you

138

1 actually looked at tar as the component that you

2 wanted to point out. You wanted to point out the

3 results related to tar. And Mr. Tillery referenced

4 that Dr. Carchman had only looked at TPM; is that

5 right?

6 A. I think I referenced it.

7 Q. Okay. Did you understand that what Dr.

8 Carchman did was use the exact same numbers you had

9 used in your prior examination?

10 A. Yes.

11 Q. Okay. And you hadn't used the tar numbers

12 before; is that right?

13 A. I don't know.

14 Q. Okay. Now, standard deviation, you've now --

15 you've now testified on direct twice before the Judge

16 you didn't talk about standard deviation back in

17 January; is that right?

18 A. I thought I did. I thought I mentioned that

19 these were statistically different. I'll have to go

20 back and look.

21 Q. Do you know or are you familiar -- well, let

22 me just ask you this. Have you to this day published

23 an article on mutagenicity?

24 A. I don't believe so.

139

1 Q. Okay. You don't believe so?

2 A. No. I mean we do the testing because we make

3 chemicals and they have to be tested, but I think

4 they're sent in to the EPA and not published in the

5 normal sense of the word to the outside world.

6 Q. Well, if you've done this much work on

7 mutagenicity, then you're familiar with a concept

8 called discriminatory power; is that right?

9 A. Of course. That's not a mutagenicity

10 concept.

11 Q. It's a general scientific concept?

12 A. A general scientific concept.

13 Q. And it's a concept that has to do with

14 whether you can tell the difference in two data points

15 in a particular test; is that right?

16 A. No.

17 Q. Well, --

18 A. It has to do with whether or not you can tell

19 a difference between averages of sets of data in a

20 test so you have to have more than two points.

21 Q. Fair enough. I accept that. And

22 discriminatory power is a consideration when you're

23 dealing with mutagenicity tests; is that right?

24 A. It's a consideration of any test you do.

140

1 Q. Including mutagenicity tests; is that right?

2 A. Yes.

3 Q. And you used a document when you were here

4 before called Guidelines for the New Assay Approval

5 Committee. Do you remember that one?

6 A. I do.

7 Q. Okay. Do we have that one? This was

8 Plaintiffs' 20, and I think it's O, but it might be D.

9 I can't read it. It's O.

10 A. Thank you.

11 Q. And that is a document that you used when you

12 were here before; is that right, Dr. Farone?

13 A. I believe that's correct. Yes.

14 MR. LOMBARDI: Okay. And, Jamil, if you

15 could go to 269.11.

16 Q. (By Mr. Lombardi) And that page, Dr. Farone,

17 is -- I'll use the CKT number at the bottom, 45910.

18 Do you see that?

19 A. Yes.

20 Q. Okay. And do you see there that it's talking

21 about -- this page is talking about --

22 MR. LOMBARDI: If you just do the top one

23 first, Jamil. Just -- no. The unhighlighted one just

24 so we can see.

141

1 Q. (By Mr. Lombardi) It's talking about

2 mutagenicity testing here; is that right?

3 A. That's right.

4 Q. And then you go down and it talks about

5 discriminatory power. Do you see that?

6 A. Right.

7 Q. And it's telling the reader what the

8 discriminatory power of the mutagenicity test is?

9 A. Well, it's not telling him any specific

10 mutagenicity test where you have the data. It's

11 talking about theoretical considerations. I think it

12 says -- this has to do with a Monte Carlo simulation

13 using 1R4F.

14 Q. Okay. And it says -- it sets out a

15 discrimination level for the mutagenicity test; is

16 that right?

17 A. No.

18 Q. Well, it does say discrimination level for

19 1R4F-MSC with S9. Do you see that?

20 A. That's correct. My point is that it relates

21 to the discrimination of 1R4F.

22 Q. And then it talks about the two strains of

23 bacteria used in a mutagenicity test; is that right?

24 A. That's correct.

142

1 Q. And the two strains are the strains that were

2 actually used in the brands study; is that right?

3 A. Yeah. They've been used for a long time,

4 yes.

5 Q. Okay. And it shows that the discrimination

6 level is from minus 18 to 21 percent for the TA98. Do

7 you see that?

8 A. I see what it says.

9 Q. You don't have any reason to argue with that

10 I take it; is that right?

11 A. Well, I haven't looked at the entire report.

12 I think that it relates I have to see what that

13 relates to. Yes, I do have a reason to argue it.

14 Q. You disagree with the document?

15 A. I don't disagree with the document.

16 Q. Well, I'm just pointing out, Doctor, from the

17 discrimination level as listed in the document for the

18 TA98. Do you see that?

19 A. TA98 for this test, 1R4F. Yes, I see it.

20 Q. Okay. And you see for the TA100 it's an even

21 broader range. Do you see that?

22 A. It's minus 22 to 28 percent. That's what it

23 says.

24 Q. Okay. So that is a broader range?

143

1 A. Yes.

2 Q. Okay. And what that basically means is, say

3 for the TA100 in this test, if the discriminatory

4 power is from minus 22 to 28 percent, if there was say

5 a 20 percent difference between two substances in a

6 mutagenicity test, that would not be something within

7 the power of the test to discriminate. That's what

8 discriminatory power means generally; is that right?

9 A. I don't think so. I think what they're

10 talking about is the ability in this test to reproduce

11 the results of the same thing tested repeatedly

12 without reference to another control. That's why you

13 use controls in the test so that you can reference

14 everything to a control. And that's why we put these

15 reference cigarettes in there.

16 So because we know that in one test the

17 reference comes out 3,000 and in the next test it

18 comes out 5,000. The differences between that 3,000

19 and 5,000 are going to be in this range of minus 22 to

20 28 percent TA100 strain and minus 18 to 21 percent.

21 That's what that refers to. It's the ability to

22 remeasure that same thing over again in a test. But

23 when you run a series and you calculate the average of

24 standard deviation for an individual test, the

144

1 standard deviation describes are statistically

2 significant. It's a different issue.

3 The next time I do it I may not have the same

4 number of bacteria, I may not do it exactly the same

5 way so my numbers, the ranges, and that's been known

6 in Ames testing for decades, the numbers go up and

7 down, up and down.

8 That's why you have to have a reference that

9 you refer everything to, but within any given test, as

10 a matter of fact on the very next page on this one, it

11 shows you that they were down below 8 percent in their

12 ability to use the TA98. So you have to look at the

13 individual test, not the brand test.

14 Q. Right. But discriminatory power is something

15 that you want to look at for every test you do; is

16 that right?

17 A. You want -- yes, you want to know whether or

18 not you've got to use a lot of controls and replicates

19 because if every time you measure the 1R4F you've got

20 3000, it makes your life a lot easier. You don't have

21 to keep putting it in every test. If it's 3,000 every

22 time you don't need -- you don't need a reference any

23 longer.

24 Q. And, Dr. Farone, do you agree -- do you agree

145

1 that just because there's a statistically significant

2 difference between results in a mutagenicity test

3 doesn't mean that that translates into any additional

4 disease in humans?

5 A. Well, I'll agree with you to the extent that

6 we don't know the amount of additional disease that it

7 could translate into. That that relationship has not

8 been established, but I would not agree that it's

9 meaningless if that's what you're asking.

10 Q. No, I didn't say it was meaningless. I said

11 -- I said it does not necessarily translate into a

12 change in disease levels?

13 A. It does not necessarily translate into a

14 measurable increase in risk if that's -- that's

15 sufficient agreement. I can't go beyond that because

16 I would need that -- you know, when you do these

17 numbers and you're purposely do them and they're

18 significantly different, the Ames should be one. You

19 should take the next step.

20 Q. Let me show you what Jeffrey Harris said

21 about this at this trial.

22 A. Okay.

23 MR. TILLERY: This goes beyond the scope of

24 his rebuttal testimony.

146

1 THE COURT: Well, no. He's -- Now, this is

2 valid. No, I'll overrule it.

3 Q. (By Mr. Lombardi) This is page 80 -- 94.

4 Excuse me. And you would agree with me, would you

5 not, that statistically significant changes in the

6 composition of tobacco smoke or particular

7 constituents of smoke do not necessarily translate

8 into a change in disease, right? No, they do not

9 necessarily translate into disease.

10 Do you agree with that, Dr. Farone?

11 A. I agree with it to the extent that the

12 difference in disease rate has to be measurable and it

13 may not be. The change is very small and may not

14 measure any change in disease rate because it's too

15 small to measure.

16 Q. Okay. And, Dr. Farone, do you recognize that

17 at Philip Morris, throughout the time that they've

18 worked on these mutagenicity tests, Philip Morris

19 believed it should be kept in mind that the

20 differences being measured among different types of

21 cigarettes in the mutagenicity test are extremely

22 small and are probably at or near the limits of

23 sensitivity of the salmonella/microsome assay? Do you

24 remember that as being the thought at Philip Morris,

147

1 don't you, Doctor?

2 A. I've seen that.

3 Q. And you agree with that, don't you, Dr.

4 Farone?

5 A. Well, that's why the test was designed to be

6 able to measure changes that could tell us a

7 difference in probability of risk.

8 Q. Okay. Well, here's my question more

9 specifically, Dr. Farone, is do you agree that Philip

10 Morris believed it should be kept in mind that the

11 differences being measured between cigarettes and the

12 mutagenicity test are extremely small? Do you

13 remember that?

14 A. Yes, I do.

15 Q. And that was the thought between '77 and '84;

16 is that right, Dr. Farone?

17 A. Yes.

18 Q. And the belief at Philip Morris during the

19 time you were there was that those differences were at

20 or near the limits of sensitivity of the assay; is

21 that right?

22 A. Well, yeah. The difference -- of course, I

23 mean the differences that you measure for statistical

24 significance are based on the limitations of the

148

1 assay. That's just a statement of scientific

2 regurgitation, yes.

3 Q. But it's important though, it's important

4 when you're doing an assay and you're reviewing the

5 results to be aware of the sensitivity of a particular

6 assay. Correct, Dr. Farone?

7 A. Yes, it is.

8 Q. And that's just as true with the Ames assay

9 as with other assays; is that right?

10 A. Any test.

11 Q. Okay. And, Dr. Farone, I think you said, and

12 if I got you wrong, please correct me, that the brands

13 study was -- let me see. I'll try and get this right.

14 The brands study validates the data going back to -- I

15 wrote down 1979, but I could have had it wrong. The

16 1979 data at Philip Morris about mutagenicity?

17 A. The brands study, and only because of the use

18 of the ventilation difference between Marlboro and

19 Marlboro Lights validates the curve I showed you from

20 the Caren-Rass (sic.) study in 1979 where you see that

21 same increase with dilution.

22 Q. Okay. But actually, Dr. Farone, are you.

23 Aware that Philip Morris actually did a particular

24 study specifically, specifically to measure the

149

1 differences, the different effects of different

2 cigarette design parameters on mutagenicity?

3 A. Yes.

4 Q. Okay.

5 A. And that 1979 study was one of them.

6 Q. Well, and I'm talking about in the 1990s.

7 Are you aware that there was a study specifically

8 done?

9 A. Right. Which showed I think dilutions as

10 being 15 percent of the --

11 Q. I think it was seven, but that -- I think

12 we're thinking about the same study.

13 A. The same study.

14 Q. The same study. And that document, have you

15 heard that document referred to as the parameter

16 study?

17 A. It has been. I think a combination of filter

18 efficiency and dilution ended up being --

19 Q. I said -- was filter efficiency 15 percent --

20 A. Yes.

21 Q. -- and filter dilution 7 percent?

22 A. Right. And they're closely related so it

23 ended up being over the 20 some odd percent, yes.

24 Q. Okay. And the parameter study actually was

150

1 the one that was designed to put together all the

2 studies that had been done before at Philip Morris,

3 not a brands study, correct?

4 A. That's right. It also supports this

5 conclusion that dilution and filter efficiency are a

6 very important part of mutagenicity.

7 Q. And the parameter study you know was made

8 public at a scientific meeting, correct?

9 A. Yes.

10 Q. Okay. The Society of Toxicology?

11 A. I don't remember --

12 Q. And it was -- it was published in an

13 article -- in an abstract?

14 A. I believe so.

15 Q. That's typical of when you do a presentation

16 at a scientific meeting, there's an abstract that goes

17 out with your presentation summarizing it; is that

18 right?

19 A. Yes.

20 Q. Dr. Farone, I think you also made reference

21 to Dr. Whidby's testimony and you said that -- again

22 my notes probably weren't good so I'm going to -- I'll

23 tell you that and you can correct me if I've got it

24 wrong. I think you said that Philip Morris designed

151

1 for the FTC machine to lower tar --

2 A. -- from the consumer -- from the corporate

3 product community where they specified tar levels were

4 FTC tar levels so that was the design that was used.

5 Q. Okay. And the FTC machine method at the time

6 you were at Philip Morris was the only standardized

7 method for measuring tar and nicotine deliveries in

8 the United States; is that right?

9 A. Well, it's generally accepted if that's what

10 you mean.

11 Q. Okay. Fair enough. It was the only one

12 accepted by the United States Government; --

13 A. Yes.

14 Q. -- is that right?

15 And are you -- Dr. Farone, have you done any

16 review of Philip Morris documents concerning what

17 Philip Morris had determined about how cigarette

18 deliveries of low tar and high tar cigarettes vary to

19 humans based on their FTC levels?

20 A. Yes.

21 Q. Okay. And so you know that Barbara Goodman

22 found that in all but one study, the lower tar

23 cigarette -- the lower tar in the FTC test delivered

24 less than the higher tar cigarette on the FTC test; is

152

1 that right?

12 Q. (By Mr. Lombardi) Are you aware of Barbara

13 Goodman's --

14 A. I'm aware of them. I don't agree with her

15 characterization. If you want to take the time to go

16 through them, we can do that. I do not agree with any

17 of them. There's only one study that shows that.

18 MR. LOMBARDI: I have no further questions,

19 your Honor.

20 REDIRECT EXAMINATION

21 BY MR. TILLERY:

22 Q. Well, let's take up that last point. He

23 mentioned Barbara Goodman. Did she come to some of

24 the meetings and make presentations?

153

1 A. Yes.

2 Q. Well, give the Court your interpretation of

3 her studies regarding compensation? He raised it;

4 let's talk about it.

5 A. I mean we knew that compensation occurred,

6 and we knew the levels of compensation. I think we

7 talked about this before could be extreme.

8 Condensates for nicotine, and we have variabilities

9 from smoker to smoker. On average you can get -- if

10 you have the same ratio -- I think I've stated this

11 before.

12 If you have the same ratio of nicotine and

13 tar and a high tar cigarette and a low tar cigarette,

14 when you smoke that low tar cigarette, in the range

15 that we're talking about here between Marlboro Lights

16 and Marlboro and Cambridge and Cambridge Lights,

17 you're going to get essentially full compensation.

18 Q. Now, did Miss Goodman actually come to your

19 meetings and talk about her studies?

20 A. She presented her findings at the Richmond

21 meetings that I discussed earlier.

22 Q. Okay. When you say she presented her

23 findings, explain that to the Court?

24 A. Every month we would select certain reports

154

1 to be presented at the Richmond meetings so that the

2 senior people from New York could have the benefit of

3 the information that we had collected. And Miss

4 Goodman's reports, I recall on two occasions, were

5 selected to be presented to the senior executives from

6 New York.

7 Q. And could you tell us what those reports

8 dealt with to be presented to the senior executives

9 from New York?

10 A. They dealt with the use of the human smoke

11 simulator program to smoke cigarettes as closely as

12 could be determined to the way humans smoked them, so

13 that we could understand how the tar and nicotine

14 being delivered to humans was, in fact, delivered.

15 Q. And what was the consensus or the upshot of

16 the presentations that were made at the Richmond

17 meeting by Barbara Goodman?

18 A. Well, we became aware of the fact that the

19 products should be analyzed when we were looking at

20 mutagenicity or other toxic effects. You don't

21 multiply on a per cigarette basis by the amount that

22 the FTC tar says because that's not the human

23 exposure. You multiply the numbers by the tar under

24 various smoking profiles. In a sense there are many

155

1 different ways to smoke a cigarette. What she did was

2 to break them into categories. In other words, there

3 may be an attempt to use like five profiles to

4 describe the whole general population. While that's

5 not accurate for every person, it generally gives you

6 an idea of the different tar levels you need to worry

7 about looking at the various chemical and biological

8 parameters.

9 Q. Did she accept as a given proposition that

10 people would compensate with the tar deliveries or

11 nicotine delivery ratios between cigarettes in the

12 range of Marlboro Lights and Marlboro Reds?

13 A. Yes.

14 MR. WAGNER: Objection. There's no

15 foundation for that.

16 MR. TILLERY: Well, he raised this issue.

17 MR. WAGNER: Well, he may have raised the

18 issue, but there's no foundation for the question that

19 was asked and the answer that was just given.

20 Q. (By Mr. Tillery) Let's go into that. Did

21 she accept that as a given proposition?

22 A. Yes.

23 Q. And explain that to the Court.

24 A. Well, we knew from the work that was

156

1 presented by Dr. Dunn's group about compensation that

2 if you get the tar levels too close together and you

3 have not a difference in nicotine ratio, that they

4 would compensate. And this was reported from the time

5 I went there on through, and it was a generally known

6 piece of information.

7 Q. Did she ever suggest to your knowledge prior

8 to this litigation that there was ever any question

9 about the fact that with the disparity in tar and

10 nicotine levels as there are or were at that time

11 between Marlboro Reds and Marlboro Lights that there

12 wouldn't be complete compensation?

13 MR. WAGNER: Objection, your Honor. He

14 testified now to Dr. Dunn. So he went from Goodman to

15 Dunn. There's no connection between the two. There

16 is no foundation for that.

17 THE COURT: Overruled.

18 A. Yes, these were all discussed and these as a

19 matter of fact I think I testified on other occasions

20 that various learned treaties were brought into the

21 discussions on compensation, and I think -- what was

22 it called? In some of the books, they use a different

23 word. Titration meaning nicotine titration. So, for

24 example, Goodman and Hillmanns (ph.) which was

157

1 discussed with Barbara Goodman and all those people at

2 that time dealt with the idea that you're going to go

3 to the same level of nicotine and, therefore, if you

4 have the same level of tar ratio between the two of

5 them it would go to the same level of tar.

6 Q. All right. Now, was the information that you

7 just told us about, was that shared with upper level

8 management of Philip Morris?

9 A. Yes.

10 Q. At these meetings?

11 A. Yes.

12 MR. LOMBARDI: Foundation.

13 THE COURT: Well, yeah, a very important

14 point.

15 Q. (By Mr. Tillery) When are you talking about,

16 Doctor?

17 THE COURT: I won't let this come in unless

18 you establish foundation.

19 Q. (By Mr. Tillery) When were those Richmond

20 meetings?

21 A. Well, I mean the Richmond meetings occurred

22 every month. Obviously over eight years I was there

23 going to those meetings I can't tell you who was

24 present exactly every meeting. I can tell you the

158

1 kinds of people that showed up.

2 Q. Well, why don't you tell the Court that?

3 A. The senior vice-president of operations

4 either Roy McDaul, for the first part of my tenure,

5 James Remington would always be there. And the

6 president of P.M. USA which varied over the time I was

7 there, but for the largest portion of time it would be

8 Shep Pollack. Mr. Pollack would be there. Other than

9 that there would be representatives from the product

10 committee meaning that either the chairman of P.M. USA

11 and the president of P.M. Inc. and the chairman of

12 P.M. Inc. would come, but only one or two of them.

13 They didn't all come to every meeting.

14 And in certain instances the vice president's

15 people like Bill Campbell, Jimmy Morgan. So these

16 meetings were held and actually it should be possible

17 to get the monthly meetings and see who all the people

18 were and see what the topics that were discussed at

19 those meetings.

20 And on my reliance set I think I collected

21 maybe two years of such documents. So documents do

22 exist which tell you which people were present at what

23 meetings, and you could go back and find out which

24 meetings Barbara Goodman made her presentations at,

159

1 but I don't remember that.

2 Q. And in these presentations where she would

3 make these meetings, those were the actual Richmond

4 meetings you described?

5 A. Yes, they were.

6 Q. All right. Now, you were asked questions by

7 Mr. Lombardi about the fact that while you were there

8 you knew about this ventilation causing an increase in

9 mutagenicity.

10 A. That's correct.

11 Q. What were you hired for at Philip Morris?

12 What was the plan as far as you knew?

13 A. Safer cigarettes and diversification. Two

14 big issues.

15 Q. And in terms of a safer cigarette, was there

16 an effort to do that? Other than with respect to

17 Cambridge Lights and Marlboro Lights?

18 A. Generally we were developing technology as I

19 testified before that would allow that to happen and

20 ventilation dilution was one of those technologies as

21 long as you go the distance and go really high.

22 Q. And were those part of the design parameters

23 that you helped put together in terms of

24 computerization?

160

1 A. Not only in terms of computerization, but the

2 whole purpose of developing a laser perforation system

3 was to allow the development of rapid

4 commercialization of what we call highly diluted, and

5 we're talking about over 70 percent dilution.

6 Q. Now, was the original Cambridge cigarette one

7 of those cigarettes?

8 A. Yes.

9 Q. Explain then if you can just walk us through

10 then, the technology that went into that cigarette

11 that caused it to deliver, what, .01 milligrams?

12 A. Very little. It depends on what parameter

13 you're going to use. 0.00001. Basically that was a

14 97, 98 percent diluted cigarette. So the dilution in

15 that case is very beneficial because it essentially

16 takes out virtually all the carcinogens.

17 Q. Now, what happened to that cigarette?

18 A. It was taken off the market.

19 Q. And then replaced with what?

20 A. With Cambridge and Cambridge Lights. It's

21 about 12 and 16 milligrams respectively.

22 Q. And does the Cambridge Lights maintain that

23 same scientific benefit in terms of delivery to the

24 consumer, the smoker?

161

1 MR. LOMBARDI: Objection. Foundation.

2 THE COURT: Overruled.

3 A. No, it doesn't.

4 Q. (By Mr. Tillery) Why not?

5 A. Because it has 12 milligrams of tar rather

6 than 0.00.

7 Q. And what happens when it's ventilated in the

8 way it's ventilated?

9 A. It's on the lower end of that scale

10 consistent with the difference between Marlboro and

11 Marlboro Lights.

12 Q. Let me walk you through this. From the time

13 you were there at Philip Morris and from your review

14 of documents from -- if you would take it back to the

15 beginning of the time that Marlboro Lights were

16 originally placed on the market, did Philip Morris

17 have an understanding of the design parameters with

18 respect to Marlboro Lights where if they wanted to

19 they could reduce the delivery of harmful constituents

20 of smoke to the consumer?

21 MR. LOMBARDI: A few objections, your Honor.

22 One is it's injecting design defect into the case.

23 Two, it's beyond what they did on direct and what I

24 did on cross and, three, there's no foundation for

162

1 this witness.

2 THE COURT: Overruled.

3 A. Yes.

4 Q. (By Mr. Tillery) And Mr. Lombardi talked

5 about resistance to draw. Is that one of those design

6 parameters?

7 A. It is.

8 Q. And explain a few of these design parameters

9 in terms of what they understood and if they wanted

10 to? In other words, if it was their intention to

11 produce a cigarette that actually delivered less of

12 the harmful constituents of smoke if they could have

13 done it. Explain that.

14 MR. LOMBARDI: I'm just objecting to the

15 vague use of the word "they". There's no foundation.

16 I'm not objecting to the RTD subject matter, your

17 Honor.

18 THE COURT: Well, be a little bit more

19 specific.

20 Q. (By Mr. Tillery) Well, was resistance to

21 draw one of those design variables?

22 A. Yes.

23 Q. Was selection of the tobacco one of the

24 design variables?

163

1 A. Yes.

2 Q. A lot of different variables involved?

3 A. That's correct.

4 Q. And they had an understanding of those, and

5 when I say they, I'm talking about this group that

6 made the overall decision to design, manufacture, and

7 sell cigarettes. That is the management of Philip

8 Morris that you became aware of when you worked there,

9 they knew about those, didn't they?

10 A. They knew about those things, and they were

11 constantly making suggestions to them about things

12 that could be done or should be done.

13 Q. And that's consistent with what you were

14 hired to do there?

15 A. That's right.

16 Q. So when you make these suggestions, did they

17 come in and make any changes to Marlboro Lights after

18 you were there to make them safer for the cigarette,

19 for the consumer?

20 A. Well --

21 MR. LOMBARDI: Objection. Leading.

22 THE COURT: Overruled.

23 A. The only one I can recall was the removal of

24 cumarin which was a known toxic material. But most of

164

1 the efforts went into new products. Things like the

2 Cambridge, like the Benson and Hedges less than one

3 milligram cigarette. So most of the suggestions along

4 the lines of making the product safer went into the

5 development of new products or brand extensions of the

6 existing products.

7 Q. Now, you were asked a question about why when

8 you left Philip Morris you didn't raise out and tell

9 the world all you knew, and I want to talk about that

10 time frame. And you said something about some type of

11 lawsuit or threat. Did they threaten you after you

12 left there?

13 A. Well, yes, they did. About a year after I

14 left I got a letter. I mentioned to a reporter for a

15 paper -- this is my college newspaper. We were

16 talking about what I was doing at that time.

17 Essentially. Environmental stuff like I'm doing now,

18 but I was doing it for another company, and a reporter

19 had wrote in there something to the effect that Philip

20 Morris sold products that caused cancer and, of

21 course, I didn't disagree with him, and so it ended up

22 in print. And I received a letter saying that that

23 was inappropriate. It was in violation of the

24 settlement agreement that I had made to state that

165

1 Philip Morris sold products that caused cancer so they

2 threatened to sue me. And I wrote them back a letter

3 or my attorney did saying wait a minute, that has

4 nothing to do with the reasons for the dismissal. I

5 could go to work for the FDA if I wanted to and so,

6 therefore, I was not going to be precluded from saying

7 that cigarette smoking caused cancer and that's the

8 last I heard of it.

9 Q. And it wasn't until in the 90s after you were

10 contacted by -- what federal agency contacted you?

11 A. The Food and Drug Administration.

12 Q. And it wasn't after, it wasn't until then

13 that people sat down and talked to you and asked you

14 about issues relating to what you knew at Philip

15 Morris, isn't that correct?

16 A. That's correct.

17 Q. You had mentioned that 1978 report. You

18 pulled it up and you indicated that there was some

19 clarification you wished to make when Mr. Lombardi was

20 talking to you. Do you remember that point?

21 A. Yes.

22 Q. Did you tell -- could you tell us what that

23 was?

24 A. I believe this is the report that we used

166

1 originally to show that the cigarettes that were only

2 different in dilution had increased mutagenicity, and

3 then the Rapp report that we talked about, Karen

4 Rapp's report is one that occurs after this that

5 validates it. So that Rapp report is actually the

6 second time that cigarettes have been tested where the

7 only difference is the ventilation percentage.

8 Q. Does Philip Morris continue, as far as you

9 know, to recognize the benefit of the use of Ames

10 testing in terms of mutagenicity?

11 A. Absolutely.

12 Q. And what information do you have about that?

13 A. Well, this entire brands study was done using

14 the Ames test, so I mean that's -- as far as I know

15 that's the most massive brand study. It's only been

16 done recently. That's the most massive brand study

17 that Philip Morris has ever engaged in. I think it's

18 significant they selected the use of tests that other

19 people think is one of the most valid tests in the

20 world, but apparently they don't so.

21 Q. Now, let me ask you this. You were asked

22 questions about the specific correlation between

23 increased specific disease or types of problems from

24 smoking and its correlation with mutagenicity testing.

167

1 Do you remember that question?

2 A. Yes.

3 Q. Now, I want to ask you this. After you've

4 seen the correlation, whether or not, as you said, to

5 a 99 percent statistical significance or not, has

6 there been in virtually every test you've ever seen a

7 directional movement in terms of assays that have been

8 done?

9 A. Yes.

10 Q. And could you tell the Court what that is?

11 A. Okay. We've seen that if you have more

12 carcinogens and more mutagens, the scores go up and

13 that's what's happening with Marlboro versus Marlboro

14 Lights when you smoke. You have more mutagens.

15 The problem is that if I have, as Doug Harris

16 pointed out, if I have a -- I think this is what his

17 logic is which I agree with. If you have a mutation

18 it doesn't mean you're going to get cancer. It could

19 be benign so you can't necessarily say that because

20 you have a mutation, you're going to have an increase

21 in cancer. If you have a mutation, you have an

22 increase in mutations, but that doesn't mean there's

23 an increase in measurable disease, and so that's where

24 the thing falls apart in terms of knowing, and I think

168

1 we discussed that before. You know you have a

2 mutagen, but you don't know whether it's going to

3 cause cancer.

4 Q. But if it's a portal through which, if you're

5 studying smoke condensates, you know, if it gives you

6 that result and it gives you that consistently, what

7 does that tell you if you're acting responsibly in

8 terms of cigarette design?

9 A. Change the design.

10 Q. Thank you.

11 MR. TILLERY: Your Honor, I'm going to offer

12 Group Exhibit 157 which includes a number of subparts.

13 I'll go through and identify those now. 157-A I'm

14 going to check. It may well have been previously

15 admitted. And that is the 1978 Biological Effects of

16 Smoke, May 4th, 1978 document authored by Pages.

17 157-B is the Seligman document that has been

18 identified and referenced. The specific pages were

19 referenced on both or all of these documents by CKT

20 numbers as we went through, and those should be borne

21 out on the record.

22 THE COURT: Any objection?

23 MR. TILLERY: I'm sorry. I'm not finished,

24 your Honor. Excuse me. 157-C is a June 4th, 1979

169

1 document from K. E. Rapp. Again, the CKT numbers were

2 referenced. The 157-D is a document from T. U. dated

3 October 3rd, 1984. It's a Philip Morris document to

4 E. B. Sanders. The 157-E is the Philip Morris INBIFO

5 study, brands study.

6 MR. LOMBARDI: Can you just hold that one up,

7 please, Mr. Tillery, so can I see which one it is? I

8 think --

9 MR. TILLERY: Let me just read what it is on

10 the top of the document. This is the INBIFO report,

11 0500/3372, and it's In Vitro Mutagenicity of Total

12 Particulate Matter in Mainstream Smoke. It's a report

13 generated under two different sets of smoking

14 conditions with eight commercially available

15 cigarettes.

16 Q. (By Mr. Tillery) Is this the one that you

17 took your documents from, sir?

18 A. Yes.

19 MR. LOMBARDI: I thought that was already in.

20 That's why --

21 MR. TILLERY: It may well be.

22 MR. LOMBARDI: I thought it was Plaintiffs'

23 41.

24 MR. TILLERY: Okay. G, H -- 157-G, H, I, and

170

1 J are the documents created by Dr. Farone, from the

2 analysis of the four pages of studies from the

3 preceding document.

4 THE COURT: They're demonstrative?

8 THE COURT: Given. You may cross.

9 RECROSS-EXAMINATION

10 BY MR. LOMBARDI:

11 Q. Dr. Farone, you talked about things that

12 could be done to make a safer cigarette, and I think

13 you were specifically talking about back at the time

14 you were at Philip Morris; is that right? On your

15 redirect.

16 A. I've forgotten exactly how the question was

17 worded, but I think you may be right. It was talking

18 about when I was there so.

19 Q. Okay. And just so it's clear one of your

20 thoughts at the time was to increase the nicotine to

21 tar ratio of cigarettes; is that right?

22 A. In order to reduce compensation, that's

23 correct.

24 Q. And one of the ways that you thought of doing

172

1 that was to add nicotine to the filter of the

2 cigarette; is that right?

3 A. Much the same as menthol is added to the

4 filter right now. I mean it's been done while I was

5 there and it's been done continuously since on

6 menthol.

7 Q. On menthol, not nicotine?

8 A. No.

9 Q. But you've recognized before that while that

10 might be a great idea, there are a lot of people out

11 there involved in the cigarette world that are not

12 wild about that idea. Is that fair, Dr. Farone?

13 A. I look to what I think to be my

14 responsibility and not what other people think so.

15 Q. I know. But you're -- my question is you're

16 aware, for instance, the surgeon general in 1981

17 indicated that he didn't think it would be a good idea

18 to have an increase in the nicotine to tar ratio,

19 correct?

20 A. I think that's correct. You're talking about

21 the 1981 report about smoking low delivery cigarettes?

22 Q. Yes.

23 A. I think that's correct.

24 Q. And you're aware that people like Dr.

173

1 Benowitz -- you know Dr. Benowitz, of course, is that

2 right?

3 A. I do.

4 Q. And Dr. Benowitz has over the years said that

5 he disagrees with the idea of raising the nicotine to

6 tar ratios?

7 MR. TILLERY: Well, whether he does or not,

8 that's improper on cross of his examination. That's

9 improper on --

10 THE COURT: Yeah, be sustained.

11 Q. (By Mr. Lombardi) And, Dr. Farone, you're

12 aware -- you talked about the Cambridge cigarette and

13 you said it was taken off the market I think if I

14 heard that right. Do you remember that testimony?

15 A. The 0.0.

16 Q. Right. And the 0.0 was taken off the market,

17 do you remember why?

18 A. It was not acceptable to a significant number

19 of smokers that would allow it to be kept on the

20 market without delivering some nicotine.

21 Q. Okay. It was not accepted by the consuming

22 public; is that right?

23 A. That is my understanding.

24 Q. Okay. And if you're going to sell a safer,

174

1 if you're going to have a safer cigarette, you need to

2 have one that people will buy; is that right?

3 A. I think I understand what you mean, but you

4 know, -- if you looked at it just clearly logically

5 the answer would be if they didn't buy it that's the

6 safest at all. I accept the idea that if you're going

7 to stay in business selling the product, it has to be

8 purchased by somebody, otherwise you don't sell that

9 product.

10 Q. And all I'm getting at, Dr. Farone, is that

11 consumer acceptability is a major and significant part

12 of what a cigarette designer's work is involved with;

13 is that right?

14 A. Well, that's what it is. The question is

15 whether it should be.

16 Q. Okay. And, Dr. Farone -- oh, just to -- I

17 think you just said that the initial Cambridge that

18 came out was called the ultra low tar Cambridge; is

19 that right?

20 A. I didn't say that, but you showed me pictures

21 in my cross-examination. They were written on the box

22 so I don't -- if that's what you mean by --

23 Q. Okay.

24 A. That's fine.

175

1 Q. And that was sold up through '85 or so? I'm

2 not trying to be precise. Around that time frame?

3 A. I think '85, '86, yes.

4 Q. And you're aware that there is still a

5 Cambridge ultra low tar product on the market today;

6 is that right?

7 A. Yes. At about 1.0. It was put back on in

8 about 1992. I think I had that in my chart during

9 direct.

10 Q. Okay. And you talked about the Barbara

11 Goodman studies and Dr. Dunn and what people inside

12 Philip Morris believed about compensation; is that

13 right?

14 A. Yes.

15 Q. And you are aware that during your time at

16 Philip Morris, there was the conclusion that

17 compensation didn't exist; is that right?

18 A. No. I came to Philip Morris with textbooks

19 that discussed -- we talked about this before so it's

20 kind of interesting. The textbooks all say from 1977

21 on it does exist. It's complete. They talk about

22 titration. I understand there are some reports that

23 were intended to show, to question that, if that's

24 what you're referring to.

176

1 Q. Okay. Well, let me show you what's been

2 marked as Exhibit 507-A, Dr. Farone. Have you seen

3 this document before?

4 A. Yes, I have.

5 Q. It's from your time at Philip Morris; is that

6 right?

7 A. That is correct.

8 Q. And it's from a person named Ryan in the

9 Behavioral Research Lab to H. Daniel; is that right?

10 A. Yes. Frank Ryan to Harry Daniel.

11 Q. Okay. And the document says -- let's -- the

12 first page it says a summary.

13 MR. LOMBARDI: And let's just go to the first

14 part of the summary, Jamil.

15 Q. (By Mr. Lombardi) "We have been examining

16 the effects of delivery change on number of cigarettes

17 smoked per day for several years in the hope that we

18 could support an intake quota hypothesis based on tar

19 and/or nicotine." Do you see that?

20 A. Yes.

21 Q. And the intake -- excuse me -- I lost my

22 place, Dr. Farone. The intake quota hypothesis refers

23 to the idea that you have a certain amount of nicotine

24 or tar you need to get; is that right?

177

1 A. Not quite. It's intake based on the number

2 of cigarettes you smoke. This doesn't discuss smoke

3 condensation.

4 Q. Okay. Well, let's go down to the next

5 paragraph. "But to date we can offer no convincing

6 evidence that a simple quota exists. To the contrary

7 our studies suggest that smokers either do not change

8 the number of cigarettes they consume where the

9 delivery is lower or else they change by truly trivial

10 amounts." Do you see that?

11 A. The numbers, yes.

12 Q. Okay. Let me show you another one. I've

13 handed you what's been marked as Exhibit 4165, Dr.

14 Farone. And for the record I'll just say it's a

15 January 23rd, 1978 document from Dr. Dunn, who you

16 referred to; is that right?

17 A. That's right.

18 Q. To Al Udall; is that right?

19 A. That's right.

20 Q. Okay. And have you seen this document

21 before?

22 A. I don't recall.

23 Q. And in this paragraph, let's just go from

24 there's a problem in the ambiguity of the phrase smoke

178

1 more?

2 A. Right.

3 Q. It says there is a problem in the ambiguity

4 of the phrase "smoke more" and then it goes through

5 what do people do when they switch and it lists

6 various types of ways they can smoke more; is that

7 right, Dr. Farone?

8 A. Yes.

9 Q. And those are -- in the general sense those

10 are different forms of compensation; is that right?

11 A. In general, yes.

12 Q. Okay. And then it says all that is

13 internally consistent by virtue of the fact that there

14 can be compensatory alterations in smoking behavior in

15 the predicted direction, but usually not enough to

16 correct for the delivery difference. Do you see that?

17 A. Yes.

18 Q. Okay. Let me show you another one, Dr.

19 Farone. Now, Dr. Farone, I've put in front of you

20 2506, a February 22nd, 1979 memo from Wakeham to

21 Seligman. Do you see that?

22 A. Yes, I do.

23 Q. Have you seen this one before?

24 A. I am not sure.

179

1 Q. Okay. If you look at the top of the second

2 page, it says, "The titration hypothesis has not found

3 support." Do you see that?

4 A. I see it, but it was in textbooks at that

5 time.

6 Q. But at any rate, this is what Dr. Wakeham was

7 saying internally to Dr. Seligman as of this date; is

8 that right, Dr. Farone?

9 A. I'll agree that that's what he was saying.

10 Q. But -- and you understand the titration

11 hypothesis to refer to the idea that people will smoke

12 to get a particular level of nicotine; is that right?

13 A. No.

14 Q. Okay. One more, Dr. Farone. And this is

15 Exhibit 2505, Dr. Farone.

16 A. Yes.

17 Q. And this is from Dr. Dunn again, dated June

18 6th, 1983. It says to circulation; is that right?

19 A. Yes.

20 Q. And one of the people to whom it's circulated

21 is you; is that right.

22 A. That is right.

23 Q. And then you received this around that time?

24 A. Yes, I did.

180

1 Q. Okay. And it's talking about an attached

2 article. Do you see that?

3 A. I do.

4 Q. Okay. And then it -- the middle paragraph

5 there says, "The conclusion for those of you unable to

6 find the time for a firsthand reading is a basic

7 laboratory controlled research suggested yes, smokers

8 do regulate nicotine intake, but no, not to the degree

9 to be expected to maintain body level constancy,

10 however, applied research under more natural smoking

11 conditions has offered essentially no support for

12 nicotine regulation, but failure to do so could very

13 well be the function of." And then it goes on from

14 there. Do you see that?

15 A. Yes.

16 Q. That's a document that you received in June

17 1983 before you departed from Philip Morris; is that

18 right?

19 A. I did.

20 Q. Okay. And, your Honor, I would offer that

21 document into evidence.

9 Q. (By Mr. Lombardi) Okay. Dr. Farone, did you

10 receive documents of this nature during your time at

11 Philip Morris?

12 A. Yes, I did.

13 Q. And did you receive them in the ordinary

14 course of business?

15 A. Yes.

16 Q. And were they maintained in the files at

17 Philip Morris?

18 A. I presume that's why it's here, yes.

19 Q. And it was Philip Morris' policy and practice

20 to maintain documents of this nature in its files?

21 A. For the most part.

22 MR. LOMBARDI: I offer it again, your Honor.

23 MR. TILLERY: May I voir dire on that point?

24 THE COURT: Sure.

182

1 VOIR DIRE EXAMINATION

2 BY MR. TILLERY

3 Q. Do you know if, in fact, this document was

4 recorded contemporaneously and placed in the files

5 contemporaneously with the dates listed on the top of

6 the document?

7 A. No, I don't.

8 Q. Okay. And you don't know if it's there today

9 or not, do you? In their files?

10 A. No, I don't.

11 Q. Okay.

12 A. As I said I presume it because they had

13 produced it.

23 RECROSS EXAMINATION (CTD.)

24 BY MR. LOMBARDI:

184

1 Q. And one last question, Dr. Farone. You

2 understand that the brands study, that you referred to

3 today, has been submitted for publication to a

4 journal? Do you understand that?

5 A. I wasn't quite sure. I thought it had been

6 rejected. It was submitted before or taken back and

7 resubmitted or something like that.

8 Q. Actually it's just been submitted for the

9 first time. Were you aware of that, Dr. Farone?

10 A. I think during my deposition I had asked that

11 question of you so I was not aware of that.

12 MR. LOMBARDI: I have no further questions

13 then.

14 RE-REDIRECT EXAMINATION

15 BY MR. TILLERY:

16 Q. What do you think the odds are with that type

17 of statistical analysis -- type of analysis of ever

18 winding up in the peer review journals?

19 MR. LOMBARDI: Objection. Leading.

20 THE COURT: Overruled.

21 A. Well, I think it will be changed by the

22 reviewers, but that's my personal opinion.

23 MR. TILLERY: Nothing else, your Honor.

24 MR. LOMBARDI: I have nothing.

185

1 Your Honor, may I -- just on these documents,

2 may I just ask a couple more questions just to make my

3 record more complete?

4 THE COURT: Sure.

5 MR. LOMBARDI: Thank you, your Honor.

6 RE-RECROSS EXAMINATION

7 BY MR. LOMBARDI:

8 Q. With respect to those, I think it was four

9 documents I put in front of you, Dr. Farone, 5078,

10 2506, 4165, and 2505. Do you have those back with

11 you?

12 A. Well, there's three I have here. If you

13 include this last one, is that what you mean?

14 Q. Yeah. I am including that one.

15 A. Yes.

16 Q. There was a practice at Philip Morris --

17 there was something called central files at Philip

18 Morris?

19 A. That is correct.

20 Q. And there was a practice of sending documents

21 to central files; is that correct?

22 A. Not all of them, but most of them, yes.

23 Q. Okay. And documents within your particular

24 area of the company were sent to central files; is

186

1 that correct?

2 A. In my area, yes. Not necessarily Dr.

3 Osdene's area.

4 Q. Okay. So, for instance, a document with your

5 name on it, 2505, was a document that would have been

6 sent to central files?

7 A. No. I didn't write it. The person that

8 writes it has the obligation to send it to central

9 files.

10 Q. Okay.

11 A. Not the person who receives it.

12 Q. Okay. And the ordinary practice would be to

13 send the document to central files?

14 A. It depends on whether it's sensitive or not.

15 Sensitive things were not sent to central files.

16 Q. Okay. 2505 is the type of document that

17 would have been sent to central files; is that right?

18 A. I don't know which one --

19 Q. That's the one that had your name on it. The

20 June 6th, 19 --

21 A. Most likely, yes.

22 MR. LOMBARDI: Okay. And I would offer that

23 one again, your Honor, under --

24 THE COURT: Be denied. Where are we?

187

1 MR. LOMBARDI: That's all I have, your Honor.

2 THE COURT: Anything else?

3 MR. TILLERY: Nothing else.

4 THE COURT: Thank you, Doctor. You'll be

5 excused.

William Farone - Rebuttal

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