Jeffrey Harris, M.D., PhD. - Testimony Excerpt (Medical)
1
1 THE COURT: You may be seated; good morning.
2 MR. SWEDLOW: We'll call our first witness,
3 Jeffrey Harris.
4 (Witness sworn.)
4 DR. JEFFREY HARRIS
5 being called as a witness in behalf of the plaintiffs
6 being first duly sworn upon his oath, was examined and
7 testified as follows:
8 DIRECT EXAMINATION
9 BY: MR. SWEDLOW
10 THE COURT: All right. Proceed on that basis;
11 you may proceed.
12 Q. Good morning. Please state your name and
13 address for the record.
14 A. My name is Jeffrey Harris; my address is 52
15 Hedge Road in Brookline, Massachusetts.
16 Q. Where did you go to college, and when did you
17 graduate?
18 A. I went to Harvard College; I graduated in
19 1969.
20 Q. What was the next step in your educational
21 process?
22 A. I went to graduate school and medical school
23 at the same time in the University of Pennsylvania. I
24 finished medical school with a degree in 1974, and
4
1 during my internship I got a PhD in economics in 1975,
2 again, from the University of Pennsylvania.
3 Q. Is that the end of your formal educational
4 process?
5 A. No. Then I continued with my post-medical
6 school residency training at the Massachusetts General
7 Hospital; that would be 1974 through 1977.
8 Q. Where are you currently employed?
9 A. Since 1976, I have been a faculty member in
10 the economics department at the Massachusetts Institute
11 of Technology and with a joint appointment in a program
12 with the Harvard Medical School. And, in addition, I
13 have remained on the medical staff of the Massachusetts
14 General Hospital where I trained. I am a primary care
15 physician there and continue to see patients.
16 Q. So if I understand what you are saying
17 correctly, you are a full-time practicing medical doctor
18 as of today?
19 A. Yes. I saw patients until about 5:00 o'clock
20 last night.
21 Q. And when did you become a full-time practicing
22 medical doctor?
23 A. I guess when I started my internship. That
24 would have been in July 1st, around July 1st, 1974.
5
1 Q. How many patient encounters have you had in
2 your medical career?
3 A. I would estimate easily over ten thousand.
4 Q. And you are also a full-time economics
5 professor at MIT?
6 A. Yes. I teach a full course load.
7 Q. When did you become a full-time economics
8 professor at MIT?
9 A. That's in 1976.
10 Q. Have you taught courses at any other
11 institution other than MIT?
12 A. During a sabbatical in the late 1980's I was
13 an associate professor of biostatistics at the Harvard
14 School of Public Health.
15 Q. Can you list for me, in general terms, what
16 courses you have taught at MIT?
17 A. In the Economics Department I have taught
18 courses in macroeconomics, health economics, economic
19 statistics, a field called industrial organization that
20 encompasses anti-trust economics. I have also given
21 special seminars on AIDS, a seminar on toxicology and
22 public policy that was jointly taught with a member of
23 the Toxicology Department.
24 Q. I would like --
6
1 A. I can't think of anything else right now.
2 Q. Didn't meant to interrupt. I would like to
3 next cover your public-service contributions. To speed
4 up this qualification process, I am going to identify an
5 organization and you will just -- if you can, tell me
6 your involvement with that organization; the first
7 organization is the National Cancer Institute.
8 A. I have been a consultant to the National
9 Cancer Institute at least two times I can think of, but
10 most recently I was asked to make a presentation in
11 front of the President's Cancer Panel in 1994 concerning
12 the issue of whether the tar in one cigarette is the
13 same as the tar in any other cigarette. That was about
14 1994.
15 Q. Did that result in a published paper of any
16 kind?
17 A. Yes. My presentation was published in a
18 volume called National Cancer Institute Monograph Number
19 7, which I think appeared in 1996.
20 Q. You would have no way to know that, but this
21 has already been admitted into evidence. Were you an
22 author of a chapter of Monograph 7?
23 A. Yes. The presentation I made was converted
24 into a written chapter in that volume.
7
1 Q. What have you done with respect to the Centers
2 for Disease Control?
3 A. I advised the Centers of Disease Control
4 concerning estimates of how many people were infected
5 with the HIV virus. That goes back to some work I did
6 in the 1980's, in which there was considerable
7 uncertainty about how many people were actually HIV
8 infected, and in that connection my task was to advise
9 the CDC, as it is called, on mathematical models to
10 estimate just how many people in the country had HIV but
11 still had not yet come down with AIDS.
12 Q. Next, the Office of the Surgeon General, what
13 was your involvement with that office?
14 A. Starting in late 1978, I participated in a
15 number of Surgeon Generals' Reports. I wrote a chapter
16 in the 1979 Surgeon General's Report, the fifteenth
17 anniversary of the Surgeon General's Report, on trends
18 in smoking rates.
19 In the 1980 Surgeon General's Report, which was on
20 smoking and women especially, I also wrote a chapter. I
21 participated as a consulting editor and in some cases a
22 senior reviewer of a number of other Surgeon Generals'
23 Reports from that point on. I was a consulting editor
24 in a Surgeon General's Report in the early 1980's called
8
1 the Changing Cigarette. In 1989, I wrote a chapter in
2 that Surgeon General's Report, which focused on how does
3 a scientist go about estimating the number of people who
4 have been stricken with and died from smoking-related
5 illnesses in a particular year.
6 Q. Next your involvement with the Veterans
7 Administration.
8 A. During the 1990's -- I don't think it is
9 called the general counsel but the chief attorney of the
10 Veterans Administration issued an opinion letter that
11 smoking-related illness would be considered a service-
12 related disability, and at the time the Veterans
13 Administration asked my advice on if this opinion were
14 to go into force, how many people -- how many US
15 veterans going all the way back to survivors from the
16 First World War would end up making claims under this
17 new standard and how much it would cost the VA.
18 Q. Well, I'm not going to ask you what that
19 number was because I don't think it is necessarily
20 relevant here. So, the next would be the Consumer
21 Product Safety Commission.
22 A. In the 1990's the Consumer Product Safety
23 Commission was investigating the issue of a fire-safe
24 cigarette, which I think that is self-explanatory. And
9
1 my task was to contribute to a chapter on how one might
2 go about systematically testing the potential adverse
3 health effects of a cigarette that was to be modified to
4 reduce fire hazards.
5 Q. And, finally, the Massachusetts Department of
6 Public Health.
7 A. I have been a consultant to the Massachusetts
8 Department of Public Health since the early 1990's in
9 connection with a tobacco control campaign, which was
10 funded in, I believe, 1991 or 1992 as a result of a
11 voter referendum, and my task has been to provide input
12 as to whether or not the tobacco control campaign that
13 is conducted by the state, in fact, had an affect on
14 smoking rates in Massachusetts.
15 Q. I would like to identify legislative bodies
16 for which you provided invited testimony. But rather
17 than have you describe the circumstances of each, just
18 to speed the process, I will identify the body. You can
19 tell me whether or not you have been invited to provide
20 testimony; the US House and Ways, excuse me, US House
21 Ways and Means Committee?
22 A. In the early 1990's there was a proposal to
23 raise the federal cigarette tax to fund a national
24 health-insurance proposal. And I testified. I was an
10
1 invited testifier concerning a number of issues
2 including exactly how much money would go to the federal
3 fisc if the tax was raised.
4 Q. You have also been invited to testify before
5 the US Senate Judiciary Committee?
6 A. Yes. That would have been in 1997 I think.
7 Q. The US Senate Agriculture Committee.
8 A. Yes, also invited testimony concerning
9 economic issues in smoking.
10 Q. US Judiciary Committee, excuse me, the House
11 Judiciary Committee.
12 A. Yes, I gave invited testimony there about the
13 same time.
14 Q. And then the US Senate Democratic Task Force
15 on Tobacco, did you also provide testimony?
16 A. Yes, the Chairman was Senator Conrad.
17 Q. Have you participated in the committees of the
18 National Academy of Sciences?
19 A. Yes, I have.
20 Q. What does it mean to be on a committee like
21 that?
22 A. The National Academy of Sciences was -- has
23 been established since the Civil War. I can't remember
24 whether it was a proclamation of Lincoln or an act of
11
1 Congress. But it is a semi-autonomous
2 government-related scientific advisory body that will
3 answer questions which congress or the executive branch
4 commissions, and in response to each question they will
5 convene an expert committee of outside scientists, and I
6 was asked and invited to participate in a number of
7 those committees on different topics.
8 Q. I want to change gears for a minute. Are you
9 familiar with the Massachusetts Benchmark Study?
10 A. Yes, I am.
11 Q. What is the Massachusetts Benchmark Study?
12 And can we display 049? There we go. What is the
13 Massachusetts Benchmark Study?
14 A. The Massachusetts Benchmark Study is a study
15 performed by four US cigarette manufacturers performed
16 in 1999, to the best of my knowledge, although issued
17 finally in 2000, to respond to a proposed regulation
18 that was issued by a state agency, namely, the
19 Massachusetts Department of Public Health.
20 Q. If I could just interrupt for a minute. Do
21 you know why this study was conducted?
22 A. I think so.
23 Q. Can you tell us why?
24 A. The Massachusetts Department of Public Health
12
1 proposed a regulation that would mandate that
2 manufacturers that sold cigarettes within the state of
3 Massachusetts test individual chemical constituents of
4 cigarette smoke and then disclose the results of such
5 testing to the state agency, and then that would be for
6 all brands of cigarettes that were sold in the state
7 since, essentially, there's a national market for
8 cigarettes; that's essentially meaning all cigarettes
9 sold in the United States.
10 Q. So all cigarettes -- the proposal was that all
11 cigarettes sold in Massachusetts would be required to
12 submit to this kind of testing, so, essentially, that
13 would be all cigarettes sold in the United States?
14 A. Yes, with some exceptions. There are local
15 markets, but when the state was proposing this mandate,
16 it is really covering all the major brands that will be
17 sold in every state.
18 Q. Prior to your involvement in this case, have
19 you submitted for peer-review publication any analysis
20 of the data in this Massachusetts Benchmark Study?
21 A. Yes, I have.
22 Q. Can you display 033401? Is that, in fact, the
23 article that you submitted and then was later published?
24 A. Yes, it is.
13
1 Q. Please tell me what you were studying or
2 describe, in your own words, what you were studying with
3 respect to this analysis.
4 A. To do that I would have to give some
5 background on what was the purpose of the benchmark
6 study.
7 Q. Why don't you provide us that background.
8 A. In response to the proposed regulation to test
9 every brand for every suspected or known toxin,
10 manufacturers voluntarily performed testing for a
11 particular year, 1999, on twenty-six what were purported
12 to be representative brands or subbrands, if I could get
13 into that, as well as one research cigarette, to test
14 the hypothesis that it was sufficient to know basically
15 the published FTC tar rating of a cigarette.
16 That's the numbers that appear in advertisements in
17 the pack that come from the Federal Trade Commission,
18 and that the tar rating would be a reasonable benchmark
19 or indicator of what the constituents, the
20 concentrations of the remaining constituents would be.
21 Q. So the determination or the analysis was to
22 determine whether the tar rating, the machine-measured
23 tar rating was indicative of the levels of the toxic
24 substances that were actually being delivered in the
14
1 smoke, is that what was being determined?
2 A. That's a fair characterization, yes.
3 Q. What were you trying to determine with respect
4 to your article?
5 A. I had already given a presentation to the
6 President's Cancer Panel in the 1990's concerned that
7 tar is not tar is not tar; but, rather, the amount of
8 tar in a cigarette is not necessarily an accurate
9 indicator of the constituents of particular toxic
10 chemicals. This article was about one class of toxic
11 chemicals called tobacco specific nitrosamines.
12 Q. When you say tar is not tar, what is tar? Can
13 you describe for the Court what, in fact, tar really is?
14 A. Technically, a cigarette is smoked by a
15 machine. The smoke is passed through a filter. Those
16 elements of the smoke, which are evaporated or part of
17 the vapor will go through the filter; the remaining
18 elements are called the particulate phase. Those
19 particles condense on the filter. The water is removed;
20 the nicotine is, by definition, removed, and the mass of
21 whatever is left is altogether called tar.
22 Q. So the mass of whatever is left is what we
23 call tar, but is it actually made up of more than just
24 one substance?
15
1 A. It's well-known it is made up of thousands of
2 substances.
3 Q. Turning back to your analysis here. What was
4 the conclusion that you drew from your analysis?
5 A. Well --
6 Q. Can we blow up the conclusion section there?
7 I will read it into the record. FTC ratings for tar,
8 nicotine and carbon monoxide do not tell the entire
9 story about the comparative yields of toxic agents in
10 marketed cigarette brands. On what did you base that
11 conclusion?
12 A. That was based on the data from the
13 Massachusetts Benchmark Study, focusing specifically on
14 the yields of tobacco specific nitrosamines and how well
15 they correlated with the FTC tar ratings of the
16 individual brand.
17 Q. You refer to significant manufacturer specific
18 effects. What do you mean by that?
19 A. Quite apart from the published FTC tar rating
20 of a particular cigarette, which manufacturer produced
21 the cigarette was a statistically significant predictor
22 of how much nitrosamine, how much of tobacco specific
23 nitrosamine was yielded from the cigarette.
24 Q. Did you do a comparison in this article
16
1 manufacturer by manufacturer?
2 A. Yes, I did. There were four manufacturers,
3 and they were identified within the text of the article
4 as A, B, C and D.
5 Q. And who had the highest levels of tobacco
6 specific nitrosamine in their products based upon your
7 analysis?
8 A. Although it was not published within the
9 article, that was, in fact, manufacturer number C, which
10 was, in fact, Philip Morris.
11 Q. Why was it not published within the article?
12 A. I didn't think that it added anything
13 scientifically. I thought what was more important was
14 the mere fact that if there were what I called
15 manufacturer specific effects, then that meant that
16 tobacco curing, blending and processing, the processes
17 that are undertaken by a particular company, affect the
18 composition of the tar, and that those processes are
19 important predictors of the yields of toxic substances
20 in the cigarette quite apart from just the total amount
21 of tar in the cigarette.
22 Q. I wanted to turn back to the Massachusetts
23 Benchmark Study testing, itself. I think we already
24 covered who did the testing, but can you identify for me
17
1 the four companies, if you can recall, who did the
2 testing?
3 A. I should say that the Massachusetts Department
4 of Public Health designated the particular toxic
5 constituents of smoke, which were to be tested. The
6 manufacturers then voluntarily took on the
7 responsibility of testing each one of those
8 constituents, and they divided up the task among their
9 four research laboratories.
10 Q. And was Philip Morris included in the group
11 that divided up these tasks?
12 A. Yes, it did some of the testing of some
13 constituents.
14 Q. Can you display 049331? This is a page from
15 the Massachusetts Benchmark Study, Table 2, the
16 mainstream smoke phase assignment for smoke constituents
17 tested in the benchmark study, and with this study aid I
18 will ask you what specifically was tested in the
19 Massachusetts Benchmark Study?
20 A. These compounds -- together they should amount
21 to 43 so the study tested the tar level, that would be
22 like number 44, even though tar isn't an individual
23 chemical compound, and then the remaining 43 are these
24 individual compounds, and the table is divided into two
18
1 panels.
2 The vapor phase, that's the evaporated component of
3 smoke that will pass through the filter when it is
4 collected, and the particulate phase are those elements
5 which will not pass through the filter but will be
6 collected in the form of particles on the filter.
7 For example, acetaldehyde on the top left is a
8 volatile aldehyde substance; it's in the vapor phase.
9 To give another example, well, on the particulate phase
10 there will be a metal of -- nickel in this case. There
11 are -- it is known that there are -- there is some
12 nickel in cigarette smoke; nickel is a particular metal.
13 Q. All of these appear within the cigarette
14 smoke; these are constituents of the smoke, is that
15 correct?
16 A. Yes. This was known well before the study
17 from numerous other published analyses of the
18 composition of cigarette smoke.
19 Q. And I think we will get into some of those
20 other analyses. I want to clarify the particulate phase
21 that's what would be in what we call tar, is that
22 correct?
23 A. Yes, with the exception that the number tar
24 actually takes out the water in nicotine.
19
1 Q. And then the vapor phase is delivered in the
2 same ratios as the tar, but it's not actually inside or
3 part of the mass that we call tar?
4 A. The ratio of vapor constituents, the tar could
5 vary, but it comes part and parcel of cigarette smoke.
6 These are, by no means, all of the chemical constituents
7 of cigarette smoke.
8 Q. Can we display 900781? This is a page from
9 the Massachusetts Benchmark Study, and actually why
10 don't you describe what this page shows to us?
11 A. This is part of a table called Table 10, which
12 shows the yields of what is called mainstream smoke.
13 Mainstream means the smoke that comes out of the
14 mouthpiece into the smoker's mouth, as opposed to side-
15 stream smoke, which would come out of the burning end of
16 the cigarette when it is smoldering. And side-stream
17 smoke was tested, but it is not -- the results are not
18 being indicated in this panel.
19 Q. Can you tell from this page whether Marlboro
20 Lights and Marlboro Regulars were tested in the study?
21 A. These were the results of the test for a
22 particular compound, and the compound was called
23 acrolein which is in sort of the box title up at the
24 top. Says acrolein yield micrograms per cigarette and
20
1 each one of the individual columns represents
2 measurements for a particular brand, or actually to be
3 more precise, a particular packing of cigarette so the
4 very first highlighted box in the upper right represents
5 the results for the testing of acrolein yield in
6 Marlboro King and then the abbreviations are filter,
7 hard pack, light, and then under that are five different
8 measurements, separate measurements: the average, the
9 standard deviation, the co-efficient of variation, et
10 cetera. There's statistical calculations made from the
11 underlying data.
12 MR. SWEDLOW: Q. Taking us back to where we
23 were, this page, and I will lead you so we don't waste
24 any time on this one question. This page demonstrates
23
1 that Marlboro Light and Marlboro Regular were tested in
2 both soft pack and hard pack versions, is that correct?
3 A. Correct. The abbreviation HP, for example, in
4 the top right, hard pack; another HP in the middle; if
5 you look at the bottom left highlighted, it will say
6 Marlboro filter soft pack light.
7 Q. And it appears that five replicates, does that
8 mean that five different cigarettes were tested for this
9 project?
10 A. Correct.
11 Q. Is that true for all of these constituents
12 toxic substances?
13 A. At least five, some cases up to twenty.
14 Q. Now, I want to turn back to how these
15 constituents were identified for purposes of the
16 Massachusetts Department of Public Health and then for
17 purposes of the study itself. Do you know how these
18 particular 43 substances were identified?
19 A. The direct answer to your question, the
20 Massachusetts Department of Public Health relied on a
21 list that was generated by the Department of Health of
22 the Canadian Province of British Columbia.
23 Q. If we could put up 900783 and then 784. 784
24 should have the list. Is this the same list of
24
1 substances from the Province of British Columbia that
2 was also tested in Massachusetts?
3 A. To my knowledge, yes.
4 Q. And do you understand, and I don't mean from a
5 list-to-list comparison now, but do you understand why
6 these substances were chosen as toxic substances to be
7 tested in cigarette smoke?
8 A. There is a substantial literature on the
9 chemical composition of cigarettes and which of those
10 chemicals within cigarette smoke are thought to have
11 toxic properties, and that literature includes Surgeon
12 Generals' Reports, reviews by the International Agency
13 for Research on Cancer, which is part of the World
14 Health Organization in Geneva.
15 In addition to governmental bodies listing or other
16 public bodies listing specific toxins in cigarettes,
17 there have been a number of reviews by scientists in the
18 field designating toxic substances, and this list, while
19 not inclusive of every toxic substance, represents a
20 compilation of those prior reports.
21 Q. And those -- let's display one of those,
22 900790, if we could. Are you familiar with this article
23 entitled the Changing Cigarette?
24 A. Yes, I am.
25
1 Q. I'm going to hand you a copy of this article.
2 Have you reviewed this article before today?
3 A. Yes, I have.
4 Q. This has been marked as Exhibit 81. What is
5 this article?
6 A. This is an article by Dietrich Hoffmann and
7 his wife, Ilse Hoffmann, published in the Journal of
8 Toxicology and Environmental Health in 1997 entitled,
9 The Changing Cigarette, 1950 to 1995. That reviews
10 cigarette technology during that time period and, in
11 particular, discusses many of the individual chemical
12 toxins that I just referred to from the British Columbia
13 list.
14 Q. This article identifies many of the same toxic
15 substances that were tested in the Massachusetts
16 Benchmark Study, is that correct?
17 A. Yes. I mean, I just happened to be on Table 3
18 entitled Carcinogens in tobacco and cigarette smoke
19 where carcinogen means causing cancer either in humans
20 or in laboratory animals. And although the list is
21 long, there is considerable overlap with the British
22 Columbia or Mass. Department of Public Health list.
23 Q. I didn't have my copy in front of me.
24 A. I see, for example, I see acetaldehyde that we
26
1 mentioned. I see 1,3-butadiene. I see benzoapyrene.
2 Q. So, in your opinion, there is substantial
3 overlap between the toxic substances identified by
4 Doctor Hoffmann and the list that was tested in the
5 Massachusetts Benchmark Study?
6 A. Yes, there is substantial overlap.
7 Q. You mentioned that you had some involvement in
8 the 1979 Surgeon General's Report. Was there any
9 discussion in that report as to what the toxic
10 constituents within the cigarette smoke were rather than
11 just tar?
12 A. Yes, there was.
13 Q. It also, just to speed things up, was there
14 also a discussion about the specific toxic components in
15 smoke in the 1989 Surgeon General's Report?
16 A. Yes, there was.
17 Q. I am going to hand you both of these together.
18 One is marked 82, and one is marked 83, and if you could
19 describe for the Court what each one is.
20 A. Exhibit 82 is a chapter from the 1979 Surgeon
21 General's Report entitled Chapter 14, Constituents of
22 Tobacco Smoke. And Exhibit Number 83 is a chapter from
23 the 1989 Surgeon General's Report, a rather large review
24 entitled Advances in Knowledge of the Health
27
1 Consequences of Smoking. I don't know if you want
2 anything more specific.
3 Q. I will ask you if these two portions of these
4 two Surgeon General Reports also have substantial
5 overlap in the identification of toxic substances that
6 were used for testing in the Massachusetts Benchmark
7 Study?
8 A. Yes, they do.
9 Q. Do you have an understanding as to whether
10 Philip Morris itself considers this group or substantial
11 overlap with this group of toxic substances as also the
12 constituents of concern in tobacco smoke?
20 MR. SWEDLOW: Why don't we display CKT058901
21 which has already been admitted into evidence. For the
22 record, I am not trying to establish Philip Morris's
23 intent here, just Philip Morris's recognition.
24 THE COURT: Well, even so, give some
28
1 background.
2 MR. SWEDLOW: Q. Have you seen this document
3 before?
4 A. Yes, I have.
5 Q. What is this document?
6 A. I believe it is a slide presentation by Dr.
7 Roger Walk, or at least a draft version of it, of a
8 presentation given on March 7, 2002.
9 Q. If you go to page 058905, what is displayed on
10 this page of this presentation?
11 A. The title is entitled Product Design, PM or
12 Philip Morris, Smoke Constituents List for Potential
13 Reduction by New Product Design, and under it is a list
14 of smoke constituents along with the name R. Walk,
15 Philip Morris USA.
8 MR. SWEDLOW: Q. Based upon your review of
9 this document and your analysis of the Massachusetts
10 Benchmark Study, is there substantial overlap in the
11 toxic substances identified for potential reduction by
12 Philip Morris and the toxic substances tested in the
13 Massachusetts Benchmark Study?
14 A. Yes, for example, if you go to the category
15 immediately under FTC parameters in the top left,
16 there's something called aldehydes, and there you see
17 acetaldehyde, acrolein. You go down to the next one,
18 aliphatic hydrocarbons; proceeding downward from the
19 left column you will see 1-3 butadiene.
20 If you were to instead go over to the extreme right,
21 there is a category called polycyclic aromatic
22 hydrocarbons, and you will see benzoapyrene; that's the
23 second one. That is also on the Mass. Department of
24 Public Health List. This list has a larger number of
30
1 chemicals within that category than are in the
2 Massachusetts Department of Public Health List.
3 Q. I want to turn back to the Massachusetts
4 department of Public, excuse me, the Massachusetts
5 Benchmark Study data. Do you understand how the machine
6 was set up to capture this cigarette smoke, and what I
7 mean by that specifically, is the machine puffing
8 conditions that were applied to capture the smoke?
9 A. I don't know how much background I should give
10 how much you have heard about this.
11 Q. Let's display 900780. I think that the Court
12 is generally aware of what machine-puffing conditions
13 are. I'm not asking you to describe the entire process.
14 I know you don't know who has testified before you
15 today. So what I was more interested in is the specific
16 puffing parameters that were programmed into the machine
17 to capture the cigarette smoke.
18 A. For the testing of the individual chemical
19 constituents in the Mass. Benchmark Study, the smoke was
20 collected from machine smoking of cigarettes under
21 conditions described in the highlighted paragraph 4.1
22 mainstream smoke, in particular, the puff volume was
23 forty-five milliliters. Each puff would last two
24 seconds, and the machine would take one puff every
31
1 thirty seconds. Moreover, if ventilation holes were
2 present -- please stop me if you need a definition of
3 that. Otherwise, I will just go on.
4 Q. We know what ventilation holes are.
5 A. If ventilation holes were present, fifty
6 percent of the holes would be blocked.
7 Q. I would like for you to explain what the
8 significance of that is, that fifty-percent vent hole
9 blocking; what is the result of blocking fifty percent
10 of the holes?
11 A. A critical design feature of low-yield
12 cigarettes in the US market for quite sometime now has
13 been the dilution of the smoke with air when the
14 cigarette is tested in a machine, and that dilution is
15 accomplished primarily by the insertion of holes called
16 ventilation holes in the filter.
17 Q. Now specifically --
18 A. I'm sorry.
19 Q. Go ahead.
20 A. Blocking the holes reduces the air dilution
21 effect of that design feature.
22 Q. Specifically, with respect to the Marlboro
23 Lights versus the Marlboro Regular product, what do you
24 understand to be the primary design distinction between
32
1 those two products?
2 A. The primary design distinction is that
3 Marlboro Lights has more filter ventilation than
4 Marlboro Red.
5 Q. Can you display 049346? This is another page
6 from the Massachusetts Benchmark Study, and if you could
7 identify for us what is the percentage ventilation for
8 Marlboro Lights hard pack and soft pack and Marlboro
9 Regular hard pack and soft pack?
10 A. The higher the percentage, the more
11 ventilation. These are ranked in order, but I see that
12 Marlboro King filters soft pack, LT stands for light,
13 that's the purple bar. That's twenty-five percent.
14 Marlboro Lights hard pack is twenty-six percent. By
15 contrast, the yellow highlighted bar is Marlboro; well,
16 in the common industry parlance, in consumer parlance
17 they're called Marlboro Reds. I will just say Marlboro
18 Reds hard pack are eight percent, and Marlboro Reds soft
19 pack are eleven percent.
20 Q. Looking at the Marlboro Reds, as you call
21 them, the different packings have different ventilation
22 percentages?
23 A. Yes. Since Marlboro soft -- Marlboro Reds
24 hard pack is a different packing of the same brand as
33
1 Marlboro Reds soft pack. Hard pack and soft pack are
2 different packings; they are not the same cigarette.
3 Even the data on the degree of filter ventilation
4 indicates that.
5 Q. This may be early since we don't even know
6 what your analysis is yet. But for purposes of your
7 analysis that we will discuss, how did you combine, if
8 you did, the data from the soft-pack testing and the
9 hard-pack testing because I think if I remember
10 correctly, the soft pack and hard pack were each tested
11 separately, is that correct?
12 A. That is correct.
13 Q. And what could you do, or what did you do, to
14 combine the hard-pack data and the soft-pack data?
15 A. To do analyses that were representative of all
16 Marlboro Lights, I combined the two, hard pack and soft
17 pack by using market-share data, that is, the
18 percentages of each in the market that were published
19 within the Mass. Benchmark Study. In the same way I
20 combined hard pack and soft pack to get a measurement
21 that was representative of Marlboro Reds overall by
22 using market-share weights.
23 Q. So you averaged the numbers from the hard pack
24 and the soft pack, is that what you're saying?
34
1 A. That's correct, but it is a weighted average
2 given the relative market share of each.
3 Q. For example, if the hard pack sold -- was
4 seventy-five percent of the market and the soft pack was
5 twenty-five percent of the market, you would weight the
6 average based upon that?
7 A. That is right. Where the hard pack in your
8 example is seventy-five percent of the weight.
9 Q. Where did you get your market-share data from?
10 A. It was published within the Massachusetts
11 Benchmark Study, but it was, in turn, taken from a
12 standard industry source, the Maxwell Report.
13 Q. Now, turning to your specific analysis; what
14 is it that you studied for purposes of this case with
15 respect to this Massachusetts Benchmark Study data?
16 A. In this particular case I calculated the yield
17 of these toxic constituents on a per milligram tar
18 basis.
19 Q. We have a somewhat complicated spread sheet
20 here. Can you tell the Court generally what is in this
21 spread sheet, and we will back up.
22 A. Each row is the name of a chemical, and the
23 columns represent calculations of the yield of the
24 chemical not per cigarette but per milligram tar. So
35
1 the very first column is the average yield per milligram
2 tar for Marlboro Lights. Then there is another column
3 indicating the error range; the next column is the same
4 for Marlboro what I called Regular or what you could
5 call Reds, and then there are some additional columns
6 that come from my spread sheet and indicate what the
7 difference is and also a statistical test as to whether
8 or not that difference is statistically significant.
9 Q. We'll unpack all of those terms, but just to
10 avoid objection, is this data data that you provided to
11 Philip Morris's attorneys in this case?
12 A. Yes.
13 Q. There are only forty substances listed here,
14 but you said there were forty-three substances tested in
15 the Massachusetts Benchmark Study. Why did you leave
16 three out?
17 A. There were three substances for which it
18 turned out that the method of measurement wasn't
19 sufficiently sensitive to accurately measure those three
20 substances; and, therefore, I excluded them from this
21 analysis.
22 Q. You said that there is some data here
23 regarding statistical significance. What is that; what
24 does that mean, statistical significance?
36
1 A. It means, in rough terms, is the observed
2 difference, let's say, in the yield of ammonia on the
3 top row between Marlboro Lights and Marlboro Reds, could
4 that simply be a matter of chance, or is that
5 sufficiently strong difference or large difference that
6 it is unlikely to be a matter of chance and, therefore,
7 it would be considered statistically significant.
8 Q. For how many substances tested here in this
9 study was the difference between a Marlboro Light and a
10 Marlboro Regular on a per milligram basis statistically
11 significant?
12 A. If you use the standard criterion, what is
13 called the five percent significance level, then I
14 believe it is out of the remaining forty, twenty-five
15 were statistically significant.
16 Q. When you say the five percent, where do you
17 get that five percent?
18 A. That's the standard level of statistical
19 significance that you will see in scientific articles in
20 numerous fields. It is not the only possible level of
21 significance, and, in fact, in this particular data
22 table I showed the results if you used a ten-percent
23 significance level.
24 Q. Could you display 900853? Why don't you tell
37
1 us what is displayed here?
2 A. Once I had the yields of each of the remaining
3 substances of the forty, I had twenty-five for which
4 there was a significant difference, I then display them
5 as percentage differences. So each of the bars
6 represents the percentage difference between Marlboro
7 Lights versus Marlboro Reds and there should be
8 twenty-five bars. When the bar is above the horizontal
9 or zero level, it means that Marlboro Lights has a
10 higher yield per milligram tar than Marlboro Reds based
11 on the Mass. Benchmark Study for that chemical. When
12 the bar is below the horizontal, it means just the
13 opposite.
14 Q. So for these twenty-five substances for which
15 there was a statistically significant difference
16 comparing Marlboro Lights and Marlboro Reds, how many
17 were higher per milligram tar in the lights?
18 A. Twenty-two out of twenty-five. You can see
19 there were three that went the other way where they were
20 higher in the Reds than in the lights.
21 Q. So for each milligram of tar delivered from a
22 light cigarette, a Marlboro Light cigarette, as compared
23 to a Marlboro regular cigarette, you will get this
24 percentage more of each of these toxic substances that
38
1 go up in the light cigarette and more of the three that
2 go down from the red cigarette; is that correct?
3 A. To be precise, if we take an example, take the
4 third one, which is sort of a chiffon color, benzene, I
5 can read that. That would mean that the yield of
6 benzene for each milligram of Marlboro Lights tar was
7 nearly fifty percent, forty something percent greater
8 than the corresponding yield of benzene for each
9 milligram of Marlboro Red tar.
10 Q. Why did you initially calculate these numbers
11 on a per -- why did you calibrate them, as you say here,
12 on a per milligram tar basis?
13 A. The Massachusetts Benchmark Study reports the
14 yields of constituents based on machine smoking in which
15 the machine smoked each cigarette packing or brand:
16 Marlboro Lights, Marlboro Reds, and all the others in
17 exactly the same way. However, real human smokers do
18 not do that, and to address the question what would a
19 real human smoker get from smoking a Marlboro Light
20 versus a Marlboro Red, you have to break it down and
21 start with the yield per milligram tar.
22 Q. I am not asking you to testify substantively
23 on this issue, but you understand what the term
24 compensation means?
39
1 A. Yes.
2 Q. Tell me, in your own words, what you
3 understand that term to mean?
4 A. Cigarette smokers, who are addicted to the
5 nicotine in cigarettes, unconsciously or consciously
6 adjust their method of smoking so as to seek --
7 MR. WAGNER: Waiting for him to finish.
8 THE WITNESS: So as to seek a certain level of
9 nicotine. In the process it has now been well
10 demonstrated that smokers of lower-yield cigarettes
11 either consciously or unconsciously smoke those
12 cigarettes differently or more intensively in order to
13 compensate for what would otherwise be a lower or
14 diluted nicotine cigarette.
22 MR. SWEDLOW: I will take your suggestion and
23 ask that question.
24 Q. Dr. Harris, is there any difference in the --
41
1 just taking one packing, for example, the Marlboro
2 Lights hard pack, is there any difference of any
3 significance between the cigarettes, the chemical
4 composition, blend, et cetera of the cigarettes sold,
5 for example, in Massachusetts and the cigarettes sold,
6 for example, in Illinois?
16 THE WITNESS: So a short answer would be not to
17 my knowledge there is no difference, and I can elaborate
18 as to the basis for my answer if you want.
19 Q. (By Mr. Swedlow) Please do elaborate.
20 A. Cigarettes are sold on a national market. The
21 major US manufacturers, which include Philip Morris,
22 manufacture the cigarettes in a central location; they
23 then are shipped to regional warehouses. From those
24 warehouses they are, in turn, sent to the cigarette
42
1 manufacturers' direct buyers, which are regional
2 distributors, by and large.
3 So, and those regional distributors often cover many
4 states. So, to my knowledge, when a Marlboro -- pack of
5 Marlboro Lights gets on the truck to go to the regional
6 warehouse and then to the distributor, it could go to
7 any one of the distributors from somebody in
8 Massachusetts to somebody in Hawaii.
9 Q. In fact, didn't you confirm that knowledge
10 based upon, which you are not testifying to today, the
11 damage analysis that you conducted in this case?
12 A. As part of my investigation in connection with
13 the damage analysis, I did review evidence that supports
14 my previous statement that this is the pattern, the
15 chain of distribution of cigarettes in the United States
16 as it applies to Philip Morris and other major
17 manufacturers.
18 THE COURT: He's circumstantially answered the
19 question. You may proceed
20 MR. SWEDLOW: Q. The Massachusetts Benchmark
21 Study smoking protocol, the machine conditions, did
22 those conditions account for compensation when gathering
23 the smoke from a Marlboro Light and a Marlboro Regular?
24 A. No, not really.
43
1 Q. Do the machine conditions, in fact, apply
2 identically to each cigarette when gathering the smoke
3 for this study?
9 MR. SWEDLOW: Q. Were the -- I will ask it in
10 a different way. What was the difference between the
11 machine-smoking parameters applied to the Marlboro
12 Lights and the Marlboro Regular cigarettes?
13 A. When it comes to measuring the substances, the
14 machine smoked all the cigarettes the same way,
15 according to those 45 millimeter puff volume, two second
16 duration, et cetera. The machine smoked each cigarette
17 the same way exactly.
18 Q. Could we go back to the graph? So if I
19 understand your testimony correctly, if a person
20 receives the same amount of tar from a Marlboro regular
21 and a Marlboro Light, they will receive these relative
22 percentages of these toxic substances from each
23 cigarette, is that correct?
6 MR. SWEDLOW: The generic smoker, Smoker A, if
7 that smoker gets the same amount of tar from a regular
8 Marlboro as he does from a Marlboro Light, will he get
9 the same ratio of toxic substances as reflected in this
10 chart?
11 A. Yes, to be precise, this chart shows the yield
12 or the percentages for any substance per milligram tar,
13 but if an individual smoker got the same amount of tar
14 from two different cigarettes, Marlboro Lights and
15 Marlboro Reds, then that percentage difference would
16 apply to the yield per cigarette for the smoker not just
17 to the yield per milligram tar.
18 Q. So this smoker, Smoker A, would get sixty
19 percent more cresol, for example, more than sixty
20 percent more cresol from a Marlboro Light than from a
21 Marlboro Red, is that correct?
22 A. If an individual smoked a Marlboro Light in
23 such a way as to get the same amount of tar per
24 cigarette as a Marlboro Red, then that individual would
45
1 get sixty-two and a half percent I think it is more
2 o-cresol per cigarette.
13 MR. SWEDLOW: Q. Are you familiar with the
14 Philip Morris program that has the acronym SCoR?
15 A. Yes.
16 Q. What is SCoR? Well, first, what does SCoR
17 stand for?
18 A. SCoR, Smoking Constituent Reduction. S is
19 Smoking; Co is Constituent; R is Reduction.
20 Q. Do you know who is in charge of SCoR for
21 Philip Morris?
22 A. I understand it is a Dr. Burnley.
23 Q. Dr. Burnley has had a portion of his
24 deposition admitted into evidence in this case.
46
19 (Excerpts of Dr. Burnley Deposition)
20 Q. What is your current job title?
21 A. Vice president of Operations Planning.
22 Q. And what falls under the umbrella of
23 Operations Planning?
24 A. There are three major. One is my
49
1 responsibility to do strategic planning for the company.
2 I am also responsible for production planning and
3 capacity planning. And I also manage the company's
4 effort to commercialize reduced risk product.
5 Q. My question is a little more specific than
6 that. Is the development and commercialization of light
7 cigarettes included within what you defined as Philip
8 Morris's efforts to produce reduced risk products?
9 A. I would say so. I mean, the public health
10 community and Surgeon General provided a lot of guidance
11 over the years that and their belief was that lower-tar
12 products would be a benefit to the consumer. And a lot
13 of Philip Morris's efforts over the years were focused
14 on how to make the best possible lower-delivery
15 cigarettes.
16 Q. If I am to understand, I am going to unpack
17 that answer a little bit, if that's okay with you. You
18 stated that the public health community identified lower
19 tar as a benefit. Was that benefit a reduced health
20 risk?
21 A. Yeah. My assumption is that they believe that
22 there's a dose response relationship. Less is better,
23 certainly.
24 Q. Less is better is a standard toxicological
50
1 concept, is that correct?
2 A. Yes.
3 Q. And one of those projects that occupies a lot
4 of your time is the SCoR project, is that correct?
5 A. Yes.
6 Q. SCoR stands for specific constituent
7 reduction?
8 A. Smoke Constituent Reduction.
9 Q. And this is different than the experimental
10 cigarettes that don't actually get lit, is that right?
11 A. Yes.
12 Q. SCoR is aimed at reducing constituents that
13 are bad in conventionally-lit cigarettes, is that right?
14 A. Yes.
15 Q. Before the break we were discussing the SCoR
16 program that I think I understand from your testimony
17 you are in charge of, is that correct?
18 A. Well, I am in charge of commercializing the
19 technology so that we can market products as we hope
20 will reduce the risk associated with smoking.
21 Q. Going back to the SCoR program for which you
22 are -- should I not say you were in charge of that
23 program, how should I describe that?
24 A. That's fine you can say it.
51
1 Q. Were you involved at all in the --
18 (Continuing Deposition)
19 A. Benchmark Study, no.
20 Q. Are you aware of that study?
21 A. Yes.
22 Q. Who performed the testing, if you know, on
23 that study?
24 A. Well, I can't give you a name, but it was --
53
1 our submissions were done by our research and
2 development department.
3 Q. The testing was done by the cigarette industry
4 itself, is that correct?
5 Object to the form.
6 A. There may have been testing by other people as
7 well. I don't know.
8 Q. Have you ever seen the results of that
9 testing?
10 A. I have seen some comparisons, yes.
11 Q. Is that testing considered at all in the
12 context of the SCoR program, which is aimed at reducing
13 smoke constituents?
14 A. Sure.
15 Q. Isn't the Massachusetts Benchmark Study a
16 measurement of specific constituents in the smoke?
17 A. Yes.
18 Q. And the constituents identified in that
19 program, aren't those the same constituents that Philip
20 Morris is trying to reduce?
21 A. I don't recall all of the constituents that
22 were part of the Massachusetts Benchmark, but it's very
23 likely that they are the same constituents.
24 Q. How did you -- sorry. How did Philip Morris
54
1 pick the constituents it was trying to reduce with the
2 SCoR?
3 A. Frankly, we assembled the best toxicologists
4 and scientists we have and posed the question to them.
5 And the question is, you can't go after everything, or
6 you will end up with a shotgun approach, and you may
7 never converge on a safer product. So, given what you
8 know, given what's in the literature, given what you
9 know affects these assays, the assays that you run, what
10 would you focus on. And they came back with two
11 substances, which were 1,3-butadiene and acrolein. So
12 our thrust, our focus was to find ways to substantially
13 reduce the amounts of those substances in smoke. The
14 techniques we used reduced a lot of other things as
15 well. But our focus were those two compounds.
16 FURTHER DIRECT EXAMINATION
17 BY: MR. SWEDLOW
18 Q. Let's focus on the two compounds that Dr.
19 Burnley just identified under the SCoR program,
20 1,3-butadiene and acrolein.
9 MR. SWEDLOW: Q. Let's focus on the two
10 substances identified by Dr. Burnley as harmful in
11 smoke. The two substances that are the thrust and focus
12 of the SCoR Harm Reduction Program. Do you remember
13 what those two substances are?
14 A. 1,3-butadiene and acrolein.
15 Q. If we could display 900854? Do you recognize
16 the data in this spread sheet here?
17 A. That comes from a spread sheet that I created.
18 Q. Can you read the numbers on this spread sheet?
19 A. Yes.
20 Q. Can you tell me what the percentage difference
21 is comparing a Marlboro Light and a Marlboro Regular for
22 the deliveries of 1,3-butadiene?
23 A. I would go to the smoke constituents column,
24 go down to the 6th entry. And I would see
57
1 1,3-butadiene, and then reading across I would see per
2 milligram of tar Marlboro Lights has 31.63 percent more
3 than Marlboro Reds, and if I read further along I would
4 get to something called a statistical P value, which is
5 a test of the statistical significance of the 31.63
6 percent difference.
7 Q. If a Smoker A were to smoke the Marlboro Light
8 and the Marlboro Regular in order to get the same tar
9 and nicotine, what would Smoker A get from Marlboro
10 Light as compared to a Marlboro Regular with respect to
11 this substance?
12 A. If Smoker A smoked a Marlboro Light and a
13 Marlboro Regular in such a way that he obtained the same
14 tar from each cigarette, then that Smoker A would obtain
15 an estimated 31.63 percent more butadiene per cigarette.
16 Q. The other substance identified as the focus of
17 the harm reduction efforts at Philip Morris was
18 acrolein, and rather than running through the entire
19 litany here again, let me ask you about Smoker A. If
20 Smoker A were to get the same amount of tar from a
21 Marlboro Light and a regular Marlboro, what would the
22 delivery, the comparative delivery of acrolein be to
23 that smoker?
24 A. On a per-cigarette basis the Marlboro Light
58
1 would yield to that smoker 29.1 percent more acrolein,
2 an estimated 29.1 percent.
3 Q. Now, this is going to be an arduous task, but
4 I am going to ask you to read into the record a response
5 toxic substance by toxic substance to the following
6 question. If Smoker A gets the same amount of tar from
7 a Marlboro Light and a Marlboro Regular, how much by
8 percentage more of each toxic substance will that smoker
9 get from a Marlboro Light, as opposed to a Marlboro
10 Regular?
11 A. You want me to read the whole?
12 Q. Unfortunately, yes. I can't pronounce all
13 those words.
14 A. I will just say under the hypothetical,
15 whatever you want to call it, the conditions you
16 described in which Smoker A gets the same amount of tar
17 from each cigarette if they smoked in such a way to do
18 that, then that smoker would get 61.9 percent more
19 o-cresol in Marlboro Lights, and the difference is
20 statistically significant. Do you want me to read
21 whether they are statistically significant?
22 Q. Sure. Hold on, a note for the court reporter.
23 I can give you a list with all these spellings.
24 A. The smoker would get 56 percent more
59
1 acrylonitrile, statistically significant. 47 percent
2 more benzene, statistically significant. I am going to
3 round off, if that's all right?
4 Q. That's all right.
5 A. 36.9 percent more toluene, statistically
6 significant. 34.1 percent more carbon monoxide, that's
7 also statistically significant. 31.63 percent more
8 1,3-butadiene statistically significant. 30.72 percent
9 more nitric oxide, statistically significant. 29.1
10 percent more acrolein, statistically significant. 29.1
11 percent more catechol, statistically significant. 28.4
12 percent more acetaldehyde, statistically significant.
13 28 percent more styrene, statistically significant.
14 26.9 percent more acetone, statistically significant.
15 24 percent more isoprene, statistically significant.
16 22.3 percent more propionaldehyde, statistically
17 significant. 22.2 percent more methyl ethyl ketone,
18 statistically significant. 19.6 percent more cadmium,
19 statistically significant. 17 percent more
20 butyraldehyde, statistically significant. 16 percent
21 more mercury, statistically significant. 15.7 percent
22 more hydrogen cyanide, statistically significant. 14.4
23 percent more hydroquinone, statistically significant.
24 12.2 percent more NNK, that is an example of the
60
1 tobacco specific nitrosamine, that's an abbreviation,
2 statistically significant. 11.7 percent more
3 crotonaldehyde, not statistically significant by a five
4 percent criterion. 3-aminobiphenyl 10.9 percent more,
5 statistically significant. Another nitrosamine, NNN 5.3
6 percent more, not statistically significant. Actually,
7 I think scientifically if I am going to call it not
8 statistically significant, I would not think it would be
9 appropriate to read them out because I can't say with
10 scientific confidence that that 5.3 percent is
11 sufficiently reliable to be a predictor. On the other
12 hand --
13 Q. Let me interrupt you then.
14 MR. WAGNER: Well --
15 THE COURT: I want to hear the rest.
16 MR. SWEDLOW: Go ahead.
17 THE COURT: Finish your answer.
18 MR. SWEDLOW: The part I interrupted.
19 A. When it comes to NNN, nitrosonormicotine, just
20 want to say at the standard level of five percent
21 significance, I would not report a difference because I
22 cannot reject the hypothesis of no difference using --
23 that's the classic statistical terminology at the five
24 percent significance level.
61
16 MR. SWEDLOW: I don't want you to do anything
17 you wouldn't want to do statistically so based upon what
18 you responded with respect to NNN, I would like you now
19 to identify the three substances for which the
20 statistically significant difference goes in the other
21 direction, meaning that the twenty-two that you may get
22 more in lights we have already read. Now I want you to
23 read the three that you would get less in lights
24 comparing a light to a regular cigarette under the
62
1 conditions we established?
2 A. Using the five percent standard, which I can
3 elaborate on if you want, phenol would be the first one
4 where on a -- under the hypothetical you have proposed
5 on a per-cigarette basis Marlboro Lights would get 40.8
6 percent less phenol. It would get 27.2 percent less
7 m+p-cresol. And it would get 5.7 percent less
8 quinoline.
9 Q. Have you calculated -- we are talking about
10 here a smoker who engages in what we described as
11 complete compensation the same amount of tar from a
12 light as they would from a regular, is that correct?
13 A. Yes, indeed. If an individual smoked the
14 light cigarette in such a way as to obtain the same tar
15 as the regular, then that would ordinarily be considered
16 complete or one hundred percent compensation.
17 Q. Did you calculate, based upon the data
18 provided in your spread sheets, the percent of
19 compensation that would be required in order to get the
20 same or at least the same amount of acrolein and
21 1,3-butadiene from a light cigarette as compared to a
22 regular cigarette in the Marlboro brand?
23 A. Yes, I did.
24 Q. Can you display I think it is 900789? What
63
1 does this chart show for both 1,3-butadiene and then
2 acrolein comparing Marlboro Lights and a regular
3 Marlboro?
4 A. Well, I am going to have to explain what I
5 mean by percent compensation. Just I think in summary,
6 if an individual smoked both cigarettes exactly the same
7 way as the machine did, then that would be zero percent
8 compensation. If the individual, on the other hand,
9 smoked the two cigarettes in such a way that the tar
10 yield was exactly the same, then that would be
11 considered complete or one hundred percent compensation
12 so anything between there in that range is a degree of
13 partial compensation.
14 And using a very straightforward calculation I could
15 reproduce on a pocket calculator here, I was able to
16 compute for each and every substance for which there was
17 a significant increase in Marlboro Lights, what degree
18 of partial compensation would be needed to get at least
19 as much of that substance per cigarette as in a Marlboro
20 Red.
21 Q. On a cigarette-per-cigarette comparison
22 Marlboro Lights versus Marlboro Reds, how much
23 compensation is required to get at least as much
24 1,3-butadiene from the light?
64
1 A. 8.6 percent compensation.
2 Q. On a cigarette-per-cigarette comparison
3 between Marlboro Lights and Marlboro Reds, how much
4 compensation is required to get at least as much
5 acrolein from a Marlboro Light?
6 A. 14.2 percent.
7 Q. Did you calculate the compensation -- wait a
8 second. If I understand your testimony correctly, if
9 Smoker A now is only compensating twenty percent when
10 smoking a Marlboro Light versus a Marlboro Regular, at
11 twenty percent compensation is Smoker A getting more
12 1,3-butadiene and more acrolein from a Marlboro Light as
13 opposed to a Marlboro Regular?
14 A. Yes. A smoker that had a twenty percent
15 compensation, which means that they didn't smoke them
16 the same as the machines, exactly the same, but they
17 didn't completely compensate; they got twenty percent of
18 the way there, that individual would get more of both
19 1,3-butadiene and acrolein the twenty percent per
20 compensator.
21 Q. Did you calculate the minimum compensation
22 required to get the same or more amount of toxic
23 substances for each of the twenty-two toxic substances
24 that is higher in lights on a per milligram basis?
65
1 A. Yes, I did.
2 Q. Can we display 900788? I'm not going to have
3 you read each of these into the record again. Can you
4 please describe for me what this chart shows generally
5 with respect to these twenty-two substances?
6 A. These are the twenty-two substances for which
7 on a per-milligram tar basis Marlboro Lights yielded a
8 statistically significant greater yield, and for each
9 one of those substances using the same approach, I
10 calculated the percentage compensation that would be
11 needed in order to get the same per-cigarette yield, and
12 they range from no compensation, whatsoever, that is the
13 first four compounds. The highest required compensation
14 for 3-aminobiphenyl, which is at the bottom, which is
15 62.6 percent.
16 Q. The first four compounds have the zero
17 percent. Why is there a zero in that column?
18 A. The yields of those compounds are sufficiently
19 higher for Marlboro Lights; that if the smoker smoked
20 the two cigarettes exactly the same way without any
21 compensation at all, they would still get higher yields;
22 that individual would still get higher yields of those
23 four substances.
24 Q. With zero percent compensation, Smoker A
66
1 smoking a Marlboro Light will get more of those
2 substances than smoking a regular Marlboro, is that
3 correct?
4 A. That is correct. If there is no compensation,
5 that individual smoked both cigarettes the same way just
6 as the machine smoked them the same way.
7 Q. If Smoker A were to compensate at a sixty-five
8 percent level, as I understand your testimony, Smoker A
9 would get higher levels of all twenty-two of the listed
10 toxic substances here from the cigarette smoke, higher
11 levels from the light than he would get from a regular
12 Marlboro, is that correct?
13 A. Yes, although the degree of higher level would
14 depend on the substance, but it would be correct for all
15 of those if Smoker A compensated sixty-five percent.
16 Q. I am actually going to ask you to read these
17 into the record, and let me formulate it so we don't
18 have to read in full sentences each time. Would you
19 please identify for me the minimum compensation required
20 to obtain an equal yield of each toxic constituent per
21 cigarette when comparing a Marlboro Light cigarette and
22 a regular Marlboro cigarette?
23 A. O-cresol, no compensation, zero percent.
24 Acrylonitrile, no compensation. Benzene, no
67
1 compensation. Toluene, no compensation. Carbon
2 monoxide 3.2 percent compensation. 1,3-butadiene 8.6
3 percent compensation. Nitric oxide 10.6 percent
4 compensation. Acrolein 14.2 percent compensation.
5 Catechol 14.3 percent. Acetaldehyde 15.8 percent.
6 Styrene 16.7 percent. Acetone 19.3 percent. Isoprene
7 26.3 percent. Propionaldehyde 30.7 percent. Methyl
8 ethyl ketone 30.9 percent. Cadmium 37.7 percent.
9 Butyraldehyde 44.7 percent. Mercury 47.5 percent.
10 Hydrogen cyanide 48.3 percent. Hydroquinone 52.1
11 percent. NNK, a particular nitrosamine, 58.7 percent.
12 And 3-aminobiphenyl 62.6 percent.
13 Q. I would like to ask you a more generalized
14 question with less complicated words. What is the
15 appropriate method, in your opinion, for determining the
16 relative harm of two different products?
17 A. I think the accepted approach is what is
18 called an approach based on the weight of the evidence.
19 I could elaborate on that.
20 Q. I would like you to.
8 MR. SWEDLOW: Laying the foundation for your
9 opinion, which I will get to at the end, how do you
10 under the weight of the evidence compare the relative
11 harm of two products?
12 A. Scientists in the field of risk assessment and
13 toxicology would analyze different sources of evidence
14 and combine them overall in a weight-of-the-evidence
15 approach. One such source of evidence is the yields of
16 different identified toxic substances in the two
17 cigarettes being compared.
18 Another source of evidence might be studies exposing
19 animals to the smoke from the two substances. Another
20 source would be what are called short-term tests done in
21 a test tube sometimes with bacteria or individual cells
22 in which the smoke, or some portion of the smoke from
23 the two cigarettes, are compared. If available, there
24 could be data on humans, either short-term data for
69
1 humans over sixty days or long-term epidemiologic
2 studies. An analysis of comparative risk would look to
3 the overall weight of that evidence rather than attempt
4 a rigid cookbook formula that one piece of evidence is
5 supposed to have a certain percentage input versus
6 another.
7 Q. Specifically, with respect to cigarettes and
8 comparative risks, how does the amount of known toxic
9 agents delivered to the smoker figure into this
10 weight-of-the-evidence approach you just described?
7 MR. SWEDLOW: Do you recall the question?
8 A. I believe your question what role evidence
9 from smoke constituent analysis plays in the weight-of-
10 the-evidence approach to analyzing the comparative risks
11 of cigarettes.
12 MR. SWEDLOW: I don't know if I phrased it that
13 well.
14 THE COURT: Phrasing it that way will elicit an
15 appropriate answer, go ahead and answer that question.
16 It sounded good to me. Go ahead. Is that your
17 question?
18 MR. SWEDLOW: Yes, it is; even if it wasn't, it
19 is now.
20 A. That source of evidence comparative
21 constituent yields would figure prominently. There
22 would be little doubt of anyone in the field of
23 toxicology, risk assessment or comparative cigarette
24 design.
71
1 Q. If a particular cigarette like Marlboro Lights
2 has higher yield of almost all of the toxic agents
3 measured in cigarette smoke with a significant
4 difference, what does that tell you about the
5 comparative hazard of that cigarette compared to a
6 regular Marlboro?
7 A. It doesn't tell me precisely what that hazard
8 is. I can't give you a numerical estimate, X percent
9 more. But when so many compounds have a higher yield,
10 that raises a very serious red flag that the cigarette
11 with the higher yield could have a more harmful effect
12 on the human consumer of the cigarette.
13 Q. Based upon your medical training, your
14 experience in specific research regarding cigarettes and
15 their health impact over the past twenty-five years,
16 your statistical training, your analysis in this case
17 and all that you have studied related to the issues in
18 this case, is it your opinion, to a reasonable degree of
19 medical and scientific certainty, that a Marlboro Light
20 cigarette could even be more hazardous to the smoker
21 than a regular Marlboro cigarette?
23 A. Yes.
24 Q. (By Mr. Swedlow) In addition to the
73
1 constituents toxic levels which we have discussed this
2 morning, what other sources of evidence reinforce your
3 opinion that a Marlboro Light cigarette may even be more
4 hazardous than a regular Marlboro cigarette?
5 A. With respect to evidence that I understand has
6 been introduced in this case, other pertinent sources of
7 evidence would include data from human epidemiology that
8 I understand Dr. Michael Thun has testified to and data
9 on short-term genotoxic tests of cigarette smoke and
10 cigarette smoke products that I believe Dr. Farone has
11 testified to. I can elaborate in each category if you
12 want.
13 Q. You might wind up getting a lot of objections
14 so why don't you elaborate briefly on each of those
15 categories.
16 A. With respect to human epidemiology, my
17 understanding of Dr. Tuhn's testimony is that there is
18 no epidemiological evidence that a cigarette at the tar
19 level of Marlboro Lights offers any harm reduction in
20 comparison to a cigarette at the tar level or tar rating
21 of Marlboro Reds.
22 And what is more, changes in the pattern of human
23 smoker inhalation of ventilated -- resulting from
24 cigarette ventilation of the type in Marlboro Lights may
74
1 have caused an increase in a particular kind of lung
2 cancer called adenocarcinoma, especially over the last
3 decade; that's with respect to epidemiology.
4 With respect to genotoxic tests it is my
5 understanding that others have testified that the smoke
6 that comes from a Marlboro Light has been found in
7 certain short-term genotoxic tests to be more genotoxic;
8 or, to be more precise, cigarette design technique of
9 ventilation as exemplified by Marlboro Lights or
10 embodied in Marlboro Lights itself appears to enhance
11 genotoxicity in certain short-term tests.
12 Q. In your opinion, based upon all that you know
13 and all that you have reviewed in your twenty-five years
14 of medical study and all of your specific research
15 regarding cigarettes and their health impact, in your
16 expert opinion, were the yields of these constituent
17 components of smoke comparing a Marlboro Light and a
18 regular Marlboro on a per-milligram tar basis
19 ascertainable by Philip Morris prior to this data from
20 the benchmark study?
21 A. Prior to 1999?
22 Q. Yes.
23 A. Yes.
24 Q. What do you base that opinion?
75
1 A. The individual components of cigarette smoke
2 that were listed here have been widely discussed in the
3 public scientific literature, many for decades.
4 Benzo(a)pyrene is a polyaromatic hydrocarbon identified
5 in combustion material back in the 1920's or thirties,
6 for example. In addition, techniques for measuring the
7 yields of these substances from cigarette smoke were not
8 invented yesterday. They have been available for quite
9 sometime, in many cases decades.
10 MR. SWEDLOW: Thank you.
11 MR. WAGNER: Your Honor, I want to make sure I
12 want to strike that. It is not applicable. This really
13 is a --
14 THE COURT: Overruled.
15 MR. SWEDLOW: Before I let you off the stand,
16 Dr. Harris, I want to move to admit some of the Exhibits
17 we have been using. The reason I am doing that with you
18 on the stand is in case we get objections and we need to
19 lay a foundation.
20 THE COURT: Don't say the reason why. Just do
21 it.
22 MR. SWEDLOW: I was really saying that to you,
23 your Honor.
24 THE COURT: They will take care of their
76
1 positions, the defense attorneys, that is.
2 MR. SWEDLOW: First, I would like to move for
3 admission of Exhibit 81, 82, and 83 which have been
4 provided to the Court and opposing counsel. Those are
5 the Dietrich Hoffmann article and the two chapters of
6 two different Surgeon Generals Reports.
7 THE COURT: Any objection?
8 MR. WAGNER: No objection.
9 THE COURT: They will be admitted.
10 MR. SWEDLOW: Next item is the Massachusetts
11 benchmark Study, which will be marked as Exhibit 84A and
12 B. Sorry. Just 84 but it is in two folders marked A
13 and B. This is specifically a line item in the parties'
14 authenticity or genuineness stipulation, and I will -- I
15 would like to move for its admission. I think that
16 defense counsel is going to want to make sure that I
17 included every page, and I'll give him that opportunity
18 to raise that issue at some later time if he wants.
7 MR. SWEDLOW: I guess is the question for the
8 Court, is there a relevance objection as to the Surgeon
9 General Report chapter?
.
8 CROSS-EXAMINATION
9 BY: MR. WAGNER
10 Q. Dr. Harris, good morning.
11 A. Good morning.
12 Q. We have met before, right?
13 A. Yes, that is correct.
14 Q. I'm Jeff Wagner. I represent Philip Morris.
15 Nice to see you again.
16 A. How are you?
17 Q. Dr. Harris, you have been active in tobacco
18 work for many years, correct?
19 A. Correct.
20 Q. Almost as long as you have been a
21 professional, right?
22 A. With a long hiatus in the 1980's, yes.
23 Q. This isn't the first tobacco case you have
24 testified in?
82
1 A. By no means.
2 Q. You have testified in other cases against
3 Philip Morris USA and other tobacco companies many
4 times, correct?
5 A. Going back to the original Cippollone trial in
__________
6 1988.
7 Q. Or even beyond that you have been involved in
8 tobacco litigation cases that were filed even before
_______
9 Cippollone?
__________
10 A. They were filed by the same law firm in New
11 Jersey, but the first case I testified was Cippollone.
__________
12 I think they were filed as early as '83 probably.
13 Q. You have testified against the tobacco
14 companies in cigarette product-liability cases, right?
15 A. Correct.
16 Q. And you have testified against the tobacco
17 companies for state attorney generals, correct?
18 A. Correct.
19 Q. And you have testified against the tobacco
20 companies for -- on behalf of private health insurers,
21 correct?
22 A. Yes, Blue Cross-Blue Shield, for example.
23 Q. And you have testified against the tobacco
24 companies for insurance funds and trusts in cases
83
1 against the tobacco industry, correct?
2 A. Yes, the Manville Personal Injury Trust.
3 Q. You first testified in a case involving
4 tobacco about twenty years ago in the Dewey case,
5 correct, deposition?
6 A. I think the Cippollone was actually the first
__________
7 deposition but the Dewey -- Cippollone was in Federal
__________
8 Court, Dewey was in state court. They were followed by
_____
9 the same attorneys. I was, I guess, contemporaneously
10 deposed in both.
11 Q. You testified as a paid expert for the
12 plaintiff, correct?
13 A. Correct.
14 Q. Just as you are testifying here as a paid
15 expert for the plaintiff?
16 A. That is correct.
17 Q. And in between either Dewey or Cippollone
_____ __________
18 twenty years ago in this case, you have served as an
19 expert witness for the plaintiffs in over thirty cases
20 against the tobacco companies; correct?
21 A. I don't know the number, but there were
22 numerous cases.
23 Q. You remember the Dewey case, right?
_____
24 A. Correct, I definitely do.
84
1 Q. You remember the case brought on behalf of
2 George Flynn?
3 A. No.
4 Q. How about Marie Reach?
5 A. No. The best responsive answer I can give is
6 that counsel for Rose Cippollone and Dewey likely filed
7 other contemporary cases in the state of New Jersey that
8 in principal my expert report or opinion were to be
9 offered, but I didn't give any testimony in those cases.
10 Q. How about Barnes; you recall that case?
______
11 A. The name is familiar.
12 Q. Susan Haines?
13 A. I think the Haines case is now being continued
______
14 as another -- under another name. No, yes, it is
15 continued and I believe my opinions were offered in that
16 case.
17 Q. John Berko?
18 A. Name is not familiar.
19 Q. Doris Smith?
20 A. Don't recall.
21 Q. 1984?
22 A. Don't recall.
23 Q. Case on behalf of Mr. Jagel in 1985?
24 A. If it was '85 and it is on the record, I would
85
1 draw the inference it was another case that was filed by
2 Mark Edell, who was counsel at the time.
3 Q. Caballero 1985?
4 A. Don't recall but if it was it was likely filed
5 by Mr. Edell.
6 Q. You recall testifying in a case brought
7 against the Imperial Tobacco Company in '88?
8 A. Yes, to be technically accurate, I think
9 Imperial Tobacco Company appealed a law or statute
10 passed by the Canadian Legislature. I testified on
11 behalf of the Attorney General of Canada, indeed,
12 against the interests or the position of Imperial
13 Tobacco Company.
14 Q. Is that the same case as the RJR-Macdonald
15 case?
16 A. Correct.
17 Q. That one sticks out in your mind, doesn't it?
18 A. Yes, it does.
19 Q. And it sticks out in your mind because the
20 Court was particularly critical of your testimony,
21 right?
19 Q. You continued to testify against Philip Morris
20 USA and other tobacco companies, right?
21 A. After the RJR case I didn't want to have
___
22 anything to do with it; I am under oath.
23 Q. But in 1991 you did testify again or
24 participate in a case brought by Samuel Allgood?
87
1 A. I don't remember any such case.
2 Q. In 1994 you began to work on the Engle case?
_____
3 A. I was approached by counsel for Engle, but I
4 decided not to participate; I declined.
5 Q. I'm sorry. I didn't mean to interrupt. Were
6 you done?
7 A. I was approached. I decided not to be
8 involved.
9 Q. You did participate with the state of
10 Mississippi's case in 1994?
11 A. No, I think I declined to be involved in that,
12 too.
13 Q. How about the state of Florida?
14 A. Yes. I can remember they talked me into it;
15 that is correct.
16 Q. Commonwealth of Massachusetts?
17 A. Correct. I was involved in that case. I gave
18 an expert report.
19 Q. State of Texas?
20 A. No. I did not want to have anything to do
21 with it; I declined.
22 Q. State of Maryland?
23 A. Yes, that was later, and I agreed and I filed
24 an expert report.
88
1 Q. And the case brought on behalf of Mildred
2 Richardson?
3 A. Don't know the name.
4 Q. State of Washington?
5 A. That's the Attorney General's case?
6 Q. Yes.
7 A. Yes. I was deposed in that case I believe and
8 filed an expert report.
9 Q. Case brought on behalf of Samuel Reed?
10 A. Don't remember the name.
11 Q. On behalf of the state of Arizona in their
12 attorney general case?
13 A. Yes, I believe the attorney general case in
14 Arizona and I could give you the full list of the best
15 of my recollection if you want.
16 Q. You also testified on behalf of Ironworkers
17 Local 17 in Ohio?
18 A. That is correct; that was in Akron.
19 Q. And you also participated in the case brought
20 by the Northwest Laborers Union in Washington?
21 A. I filed an expert report; I think the case was
22 dismissed.
23 Q. And you also worked on the National Asbestos
24 Workers case in Brooklyn?
89
1 A. Yes, I think so. Some of these cases were
2 dismissed. I can't recall whether I filed a report in
3 those cases or simply agreed but I would say the answer
4 is yes.
5 Q. Also worked on the Falise case, the name of
6 the first director of the Manville Settlement Trust,
7 right?
8 A. That is correct and I did work on that case.
9 Q. And you also participated in a case brought by
10 the Group Health Plan of Minnesota?
11 A. That is correct.
12 Q. You also testified in the Blue Cross and Blue
13 Shield case?
14 A. That one did go to trial, and I testified in
15 Brooklyn in the Eastern District of New York.
16 Q. You are paid for all of this testimony, right?
17 A. Yes.
18 Q. And you get paid about four hundred and fifty
19 dollars an hour?
20 A. Now I do, yes.
21 Q. Dr. Harris, just so we can ball park it, would
22 you estimate that you have been paid more than five
23 hundred thousand dollars in total for your work as a
24 plaintiffs' expert against the tobacco companies?
90
1 A. Yes.
2 Q. Is it approaching a million dollars?
3 A. Probably.
4 Q. Is it over a million dollars?
5 A. I don't know. It could well be over a million
6 dollars cumulatively over the period you described.
7 Q. Okay. Now, Dr. Harris, today you testified to
8 some calculations which you compared the composition of
9 smoke from Marlboro cigarettes, Marlboro Reds to the
10 smoke of Marlboro Lights, right?
11 A. Yes.
12 Q. And you looked at substances that the public
13 health authorities have designated as hazardous,
14 correct?
15 A. Yes. They have listed them as hazards or
16 potential hazards.
17 Q. Hazards or potential hazards. You cited I
18 think to the 1979 Surgeon General Report and the 1989
19 Surgeon General Report, correct?
20 A. Correct.
21 Q. So, these substances being harmful
22 constituents and identity or existence in cigarette
23 smoke is not anything that's been a secret, correct?
24 A. That is correct.
91
1 Q. Okay. And you concluded that on a per
2 milligram tar basis the majority of those compounds
3 showed significantly higher amounts in yields in
4 Marlboro Lights than in Marlboro, right?
5 A. Correct, based on the Massachusetts Benchmark
6 data.
7 Q. Based on that data, that's right, now in
8 connection with these calculations, you did not actually
9 run any biological or chemistry experiments or tests of
10 your own, did you?
11 A. No. I did what you would call a secondary
12 analysis. Somebody else collected the primary data.
13 Q. You didn't perform any smoke chemistry tests,
14 correct?
15 A. Not myself, same answer.
16 Q. You did not perform any biological tests,
17 correct?
18 A. That's correct.
19 Q. And you do not consider yourself an expert in
20 analytical chemistry, correct?
21 A. Correct.
22 Q. When you were doing these tests, your
23 analysis, you did not consult with any analytical
24 chemist in connection with this could be more harmful
92
1 analysis, did you?
2 A. Well, while I was doing that particular
3 analysis, no.
4 Q. You ran a statistical analysis, correct?
5 A. Correct.
6 Q. You just crunched some numbers, is that the
7 way you understand that; you ran statistical tests on
8 numbers reported by the Massachusetts test, right?
9 A. Well, I mean, if you are asking me have I
10 spent time with people like Dietrich Hoffmann, an
11 authority that I mentioned, outside of this testimony
12 and discussed the methodology for these, yes.
13 Q. What I am asking is whether or not in order to
14 put on the testimony that you did today, you looked at
15 the data that was produced in the Massachusetts
16 Benchmarking Study and conducted a statistical analysis
17 of that data? That's your work, right?
19 MR. WAGNER: Sure. All I want to know I
20 thought we were at this point. In order to testify to
21 your opinions, what you did was you ran a statistical
22 analysis of the Massachusetts Benchmarking Study data,
23 correct?
24 A. Yes, I did run a statistical analysis of that
94
1 data.
2 Q. And the data that you were analyzing was
3 voluntarily submitted to the Massachusetts Department of
4 Public Health by the tobacco companies, including Philip
5 Morris USA, correct?
6 A. Correct.
7 Q. And you would agree with me, would you not,
8 that statistically significant changes in the
9 composition of tobacco smoke or particular constituents
10 in the smoke do not necessarily translate into a change
11 in disease, right?
12 A. No, they do not necessarily translate into
13 disease.
14 Q. And your calculations that you did, and that
15 you presented to the Court this morning, don't speak to
16 whether the differences that you observed are large
17 enough to affect the biological activity of smoke;
18 correct?
19 A. I think they do speak to them. I don't think
20 they are precisely or quantitatively predictive of them.
21 Q. Let me ask you the question this way. Your
22 calculations don't prove that Marlboro Reds are safer to
23 human health than Marlboro Lights, do they?
24 A. No, I don't think any scientist would say
95
1 that.
2 Q. The converse is also true, isn't it, your
3 calculations don't prove that Marlboro Lights are more
4 harmful to human health than Marlboro Reds; correct?
5 A. Based on the standards of evidence scientists
6 would use to apply to the word prove, no, they don't
7 show that.
8 Q. And, in fact, you do not believe that it has
9 been scientifically established that smoking Marlboro
10 Lights is more dangerous than smoking Marlboros; you
11 think that conclusion would be too strong, correct?
12 THE COURT: You got two questions there.
13 MR. WAGNER: Let me break it up. Q. You do
14 not believe that it has been scientifically established
15 that smoking Marlboro Lights is more dangerous than
16 smoking Marlboros, do you?
17 A. Not scientifically established using the
18 standards that scientists would use.
19 Q. So you believe such a conclusion would be too
20 strong, correct?
21 A. Given the current state of the art, I don't
22 think, and using words that scientists use, I don't
23 think scientists would use the words proved or
24 established in connection with the proposition you
96
1 articulated.
2 Q. You are familiar with the National Cancer
3 Institute Monograph 13, correct?
4 A. Correct.
5 Q. Okay. And Monograph 13 has been represented
6 to the Court as being a consensus document regarding
7 science of low-tar cigarettes. Let me ask you this.
2 MR. WAGNER: For the preface to my question
3 that the plaintiffs at least have represented that this
4 is a consensus document regarding the current science of
5 low-tar cigarettes.
6 A. Okay. That's what you say.
7 Q. That's a preface, and you are familiar with
8 Monograph 13, correct?
9 A. Correct.
10 Q. Monograph 13, however, did not conclude that
11 low-tar cigarettes are more harmful to smokers than
12 regular cigarettes on a per-milligram basis, did it?
13 A. I don't recall that conclusion, no.
14 Q. And at present, as far as you know, Dr.
15 Harris, there is no scientific consensus that a low-tar
16 cigarette on a per milligram of tar basis increases the
17 risk to human health compared to higher-tar cigarettes,
18 correct?
19 A. No, I don't think scientists would use the
20 words proved or established or consensus with respect to
21 that proposition at this point in time.
22 Q. Okay. Now, you have discussed a number of
23 different kinds of scientific evidence in your
24 testimony. You said that -- and you were talking about
98
1 the weight of scientific evidence. Do you recall that
2 testimony?
3 A. Absolutely.
4 Q. And you said that there are different kinds of
5 things you can do: laboratory tests and other scientific
6 tests and also epidemiology, you referred to a number of
7 different kinds of tests; correct?
8 A. I would be more precise in my answer but,
9 generally, yes.
10 Q. All I want to know, Doctor, is epidemiology,
11 that particular discipline, looks at the effects in the
12 population, correct?
13 A. The effects, yes. Epidemiology in principal
14 could be used to test differences in risks of different
15 cigarettes in a population of individuals exposed to
16 those cigarettes.
17 Q. So it would take us away from the petri dishes
18 and we would be able to see if we had a population that
19 was smoking, if you had a control group versus a group
20 that was smoking low-tar cigarettes and the control
21 group say was smoking higher-tar cigarettes, you would
22 be able to see the differences in the population based
23 on how those cigarettes are actually smoked, correct,
24 would be able to see disease differences?
99
1 A. Let me make sure I understand your question.
2 Does it have anything to do with low tar and higher tar?
3 Q. Uh-hum.
4 A. There's literature in epidemiology, for
5 example, lung cancer risks comparing low tar and higher
6 tar. I thought that Dr. Tuhn had testified to that, but
7 there definitely is that literature, and that literature
8 is part of the scientific literature on risk assessment.
9 Q. And that's part of what epidemiology looks
10 like. Epidemiology can be used to look at and compare
11 populations that might be smoking one type of cigarette
12 versus another type of cigarette and compare a relative
13 disease risk between the two, correct?
14 A. Correct.
15 Q. Now, you testified a little bit to an article
16 that was written by Dr. Hoffmann and his wife, is she
17 also Dr. Hoffmann?
18 A. No, she isn't a doctor.
19 Q. I didn't want to say Doctor and Mrs. if it
20 should have been Doctor and Doctor. Plaintiffs' Exhibit
21 81, do you still have that?
22 A. Yes.
23 Q. Now, Dr. Hoffmann in his article, you want to
24 turn to page 319, Dr. Hoffmann in this article is
100
1 discussing the changing cigarette from 1950 to 1995,
2 correct?
3 A. That's the title, yes.
4 Q. Now, Dr. Hoffmann points out, Dr. and Mrs.
5 Hoffmann point out on page 319 that the design changes
6 of US cigarettes over time since 1953 have contributed
7 significantly to the reduction of tar and nicotine
8 yields in the smoke of the United States cigarettes, do
9 you see that?
10 A. I see the sentence, yes.
11 Q. And Doctor and Mrs. Hoffmann have attached a
12 chart showing the average sales weighted tar yield of
13 cigarettes sold in the United States has dropped,
14 correct?
15 A. Yes, as well as the average nicotine yield
16 with some exceptions; but, by and large, yes, it has
17 dropped.
18 Q. And then later in the article if you turn
19 ahead to page 353.
20 MR. SWEDLOW: What page?
21 MR. WAGNER: 353. They also discuss some of the
22 epidemiology, and one particular sentence I have got on
23 the screen highlighted the Hoffmanns tell us, the Cohort
24 and case-control studies have shown that in the past the
101
1 relative risk for lung cancer among long-term smokers of
2 filter cigarettes compared with that of smokers of
3 nonfilter cigarettes was 20 to 50 percent lower, and
4 they are citing the International Agency for Research on
5 Cancer in 1986, do you see that?
6 A. Yes, I do see that.
7 Q. And that's part of the body of epidemiological
8 literature involving lung cancer you were just referring
9 to a moment ago, correct?
10 A. Both Dr. Hoffmann's article and comment on
11 this, as well as the underlying citation, are, indeed,
12 literally part of the body of epidemiologic evidence.
13 Q. And you discussed also I think, as part of
14 your testimony in the scientific weight, you refer to
15 what you understood to be some testimony regarding
16 genotoxicity. I don't recall whether or not you also
17 mentioned mutagenicity.
18 A. Well, mutagenicity would be a specific example
19 and be included in genotoxicity.
20 Q. You did not express any opinions relating to
21 mutagenicity within the confines of your expert report
22 in this case, correct?
23 A. No.
24 Q. You did not express any opinion relating to
102
1 genotoxicity within the confines of your expert report
2 in this case, did you?
10 MR. WAGNER: I am going to move to the next
11 step.
12 THE COURT: Go ahead.
13 MR. WAGNER: Q. Now, genotoxicity and
14 mutagenicity, let me see if you agree with a statement I
15 want to read to you, okay, Dr. Harris?
16 A. Yes.
17 Q. Toxicity studies in nonhuman species can also
18 give estimates of relative risks but, again, applying
19 those to the human condition is fraught with
20 difficulties. The fact that the smoke from one
21 cigarette could produce twice as many revertents per
22 plate as another cigarette in, let's say, the Ames
23 Salmonella Test does not necessarily mean that one
24 cigarette in humans is definitely twice as much or four
103
1 times as much mutagenic; in fact, differences in the
2 relative mutagenicity may vary with the type of
3 immunogenicity test.
24 MR. WAGNER: Can I ask whether or not he agrees
104
1 with it? Your Honor, all I want to know first is
2 whether or not he agrees with the statement, then I will
3 show him.
4 MR. SWEDLOW: It was so long, and now we have
5 had many objections.
6 THE COURT: Well, surprise us. We will let him
7 surprise us.
8 MR. WAGNER: It is not a great surprise.
9 A. I think I wrote that because the phrase
10 fraught with difficulties I got from one of my teachers,
11 and I don't think any -- I just can't remember whether
12 it was in a monograph I wrote for the National Academy
13 of Sciences or whether it was an article in a
14 peer-review journal called Risk Analysis.
15 THE COURT: Stop this. Look, I have been fair.
16 I want to see the monogram or the document you are
17 citing from, and I want a copy to go to counsel.
18 MR. WAGNER: This is Exhibit 7138 for the
19 record. Let me ask you just a preceding question before
20 I point to you the specific page of the quote, but, Dr.
21 Harris, you testified this morning that you had
22 participated in a National Cancer Institute Conference
23 on the FTC method of low-tar cigarettes in 1994,
24 correct?
105
1 A. Correct.
2 Q. That's what led to the publication of NCI
3 Monograph 7 in 1996, correct?
4 A. Correct.
5 Q. Conference was held on December 5th and 6th,
6 1994, in Bethesda, Maryland; correct?
7 A. Correct.
8 Q. And what I have handed you as Exhibit 7138 is
9 a transcript of that conference, correct?
10 A. I am going to take your word for it, looks
11 like it.
12 Q. If you flip ahead to page 72, I believe, you
13 will see that is the beginning of the speech that you
14 gave.
15 A. Got it.
16 MR. SWEDLOW: Can you reference a page number?
17 MR. WAGNER: Page 72.
18 Q. And I only put that up on the screen just to
19 show the beginning of the speech that you gave at the
20 NCI Conference, correct?
21 A. Where it says switch gears, yes.
22 Q. Now, if we go ahead to page 87, we can
23 actually make sure we have the entire context of what it
24 is you said. Page 87 if you are there, do you see the
106
1 second full paragraph begins with the words human
2 epidemiology?
3 A. I am on 86. Hold on. Yes. I see that.
4 Q. And let's make sure these were your words, and
5 you spoke them to the NCI Conference, Human epidemiology
6 can be used to estimate quantitatively the risk of
7 specific diseases to human smokers. For example, from a
8 large study, like the CPS-2 study by the American Cancer
9 Society, one can estimate what the actual risk to a
10 smoker and a nonsmoker per year is, of lung cancer. One
11 can also take the ratio of those risks so as to come out
12 with the conclusion that continuing male smokers had an
13 incidence rate, or a death rate, that was 20-fold
14 greater than those of life-long nonsmokers. That is
15 called the relative risk. Those are the words you said
16 at the conference, right?
17 A. Undoubtedly.
18 Q. The next paragraph says, Estimating these
19 relative risks, however, from nonhuman data is fraught
20 with difficulties. We could estimate, for example, that
21 cigarette A contained two and a half times more
22 benzopyrene than cigarette B, but that does not
23 necessarily mean that the risk of lung cancer is two and
24 a half times as great. It may not even, in fact, be
107
1 that the ratio of, let's say, benzanthracene is the same
2 between the two cigarettes. Those were your words that
3 you said at the conference, right?
4 A. So far as I know, yes.
5 Q. They were true then, correct?
6 A. They were true then, yes.
7 Q. And they --
8 A. I think I have written these even earlier, but
9 absolutely they were true then.
10 Q. And they remain true today, correct?
11 A. Correct.
12 Q. And the next paragraph is the paragraph that I
13 asked you if you would agree with, said, likewise,
14 toxicity studies in nonhuman species can also give
15 estimates of relative risks, but, again, applying those
16 to the human condition is fraught with difficulties.
17 The fact that the smoke from one cigarette could produce
18 twice as many revertants per plate as another cigarette
19 in, let's say, the Ames salmonella test, does not
20 necessarily mean that one cigarette in humans is
21 definitely twice as much, or four times as much
22 mutagenic. In fact, differences in the relative
23 mutagenicity may vary with the type of immunogenicity
24 test. Those were your words at the conference, right?
108
1 A. Except that that is a mistype; it's,
2 obviously, the last word is again mutagenicity; that's a
3 transcription error.
4 Q. Those were your words with that correction?
5 A. Yes. as far as I know.
6 Q. They were true then?
7 A. Yes.
8 Q. And they're true today?
9 A. Yes.
10 Q. At that conference you recall Dr. Hoffmann
11 also giving a talk?
12 A. Yes.
13 Q. He spoke before you?
14 A. Yes.
15 Q. And Dr. Hoffmann, if you want to turn in the
16 same Exhibit to page 30, you will see that's where his
17 talk begins; correct?
18 A. Looks like it. Thank you, Mr. Chairman.
19 That's what I got.
20 Q. And the subject of Dr. Hoffmann's talk was
21 history and trends, changes in cigarette design and
22 composition over time and how they influence the yields
23 of the smoke constituents. Do you see that?
24 A. Yes, yes, I was just recalling if in substance
109
1 that was the case. It is, both in substance and also
2 what is written there.
3 Q. And that's very similar to the topics he was
4 writing about in the article you testified to.
5 A. The topic of that and many other articles.
6 Q. If you look through the speech, Dr. Hoffmann
7 goes through changes in cigarette design, for example,
8 page 32, Dr. Hoffmann talks about filtration as a design
9 change, correct, design feature of cigarettes? Pardon
10 me.
11 A. Yes.
12 Q. Okay. And on page 33 Dr. Hoffmann is
13 discussing ventilation, correct?
14 A. Yes. On the top of the page he discusses
15 that.
16 Q. And on page 34 he talks about the porosity or
17 permeability of the paper, correct?
18 A. Yes.
19 Q. Okay. And on 35 he sums up, and Dr. Hoffmann
20 says that these are the four major processes, and the
21 most encouraging appears to be the paper process. This
22 was taken up by the Tobacco Working Group. Dr. Bock was
23 a member there for years, and they tested for smoke
24 constituents as well as for tumorgenicity of the
110
1 resulting tar on mouse skin and found that especially
2 paper process can significantly reduce the smoke yields
3 as well as the gram-to-gram basis, the tumorgenicity on
4 mouse skin. That's what Dr. Hoffmann reported at the
5 NCI Conference in 1994, correct?
6 A. He probably said paper porosity rather than
7 paper process.
8 Q. With that transcription.
9 A. That's the best, obviously, I can't recall
10 verbatim what he said in 1994.
11 Q. But you have no reason to doubt that he was
12 informing the conference as of December of 1994 of the
13 Tobacco Working Group's conclusions with respect to on a
14 gram-to-gram basis the tumorgenicity that had been
15 tested; correct?
16 MR. SWEDLOW: I was going to let this go, but
17 based upon what the witness just said, I guess I would
18 object. This is now hearsay. He says he doesn't recall
19 what Dr. Hoffmann actually testified to.
20 THE COURT: Well, I'm going to overrule it. He
21 was there.
22 THE WITNESS: I was there. My best
23 understanding is that Dr. Hoffmann would have, indeed,
24 in December 1994 have testified about prior results in
111
1 the seventies, late seventies concerning the influence
2 of paper porosity on certain test results.
3 Q. And this was a report made in December of 1994
4 to the scientific community, correct?
5 A. Yes, to that convened panel of experts.
6 Q. And on page 36 there's some additional
7 discussion of additional designs such as the use of
8 reconstituted tobacco, right?
9 A. There is mention of reconstituted tobacco.
10 You would have to give me a minute to see what the
11 context is. I can see the words.
12 Q. Take your time. Second full paragraph,
13 Doctor.
14 A. Well, he happens to be arguing about an issue.
15 Q. My question is whether or not he was
16 discussing reconstituted tobacco?
17 A. Yes.
18 Q. And then further on down the page he also
19 discusses expanded tobacco, freeze dried, puffed or
20 expanded tobacco, right?
21 A. Correct.
22 Q. And if you flip over to page 37, Dr. Hoffmann
23 told you at the conference, you and the others that were
24 there, the expanded tobacco and the freeze-dried tobacco
112
1 the trials with these two cigarettes have been tested by
2 the NCI Working Group and have been found to be
3 significantly less active on a gram-to-gram basis tar.
4 You see that?
5 A. Yes.
6 Q. And that was reported to you by Dr. Hoffmann
7 at the conference, correct?
8 A. To me and others, yes.
9 Q. Now, in fact, when you presented at the NCI
10 Conference, you even proposed a new form of label,
11 didn't you?
12 A. Yes.
13 Q. You recall doing that, right?
14 A. Yes.
15 Q. And that label actually was reproduced in NCI
16 Monograph 7, correct?
17 A. Correct.
18 Q. Do you all want another copy of Monograph 7?
19 MR. SWEDLOW: See what you are showing.
20 MR. WAGNER: Showing him the pages.
21 THE COURT: Show him.
22 MR. WAGNER: I would put a copy up on the
23 monitor.
23 MR. WAGNER: Q. Dr. Harris, let me give you
24 Monograph 7 so you can follow along with what we're
114
1 talking about. In connection with your talk to the NCI
2 panel, you proposed a mock cigarette label, and that's
3 what we have got displayed on the screen, correct?
4 A. Correct.
5 Q. The cigarette -- focus in on the top -- you
6 propose is actually Harris Ultra, right?
7 A. Yes, it's a hypothetical cigarette.
8 Q. And on your choice with the hypothetical
9 cigarette you chose to use a descriptor, right?
10 A. You mean Harris Ultra, yes.
11 Q. And you were referring to the delivery of tar
12 and nicotine and other constituents that would emanate
13 from that cigarette, right?
14 MR. SWEDLOW: Are we now qualifying this
15 witness as an expert on descriptors and their
16 communicative ability of delivery?
6 MR. WAGNER: We can go back. You list on this
7 proposed label certain constituents that you were
8 proposing be listed on the label, correct?
9 A. Correct.
10 Q. And that includes not only tar and nicotine
11 and carbon monoxide, but you've got a lot of the
12 constituents you discussed with us this morning,
13 correct?
14 A. Yes.
15 Q. Including, for example, acrolein?
16 A. Acrolein, yes.
17 Q. Acrolein, I'm sorry. I pronounced that wrong.
18 Then at the bottom you also suggest that there be
19 disclosure of biological test results, correct?
20 A. Correct.
21 Q. And that includes Ames salmonella tests and
22 other tests which are mutagenicity tests, correct?
23 A. Some of them are carcinogenicity tests which
24 are not considered mutagenicity. Some of them are tests
116
1 having to do with lung disease, no relation that I know
2 of either to cancer or genetic damage.
3 Q. At the conclusion of this conference the panel
4 made a recommendation regarding the testing and
5 publication of these other constituents, correct?
6 A. They may have; I don't remember the
7 recommendation.
8 THE COURT: Are we done with the --
9 MR. WAGNER: I am just completing it.
10 THE COURT: Maybe, you know, I am not that
11 astute, I thought I was missing something.
12 MR. WAGNER: Now, Exhibit 73.2 is the statement
13 of the ad hoc committee of the President's Cancer Panel
14 to consider the FTC test method for determining tar and
15 nicotine and carbon monoxide levels in cigarettes issued
16 on December 6th, 1994, at 2:30 PM. You see that?
17 A. Yes.
18 Q. This was the statement of the panel at the
19 conclusion of the conference at which you just presented
20 and which you were just talking about, correct?
21 A. I don't know that for a fact.
22 Q. All right.
23 A. I don't know.
24 Q. You do know that the conference was held on
117
1 December 5th and 6th, 1984, correct?
2 A. Well, I guess you reminded me of that. And if
3 that is the case, it would be reasonable to conclude
4 that this was a statement issued on the last day.
5 Q. Now, at the top paragraph it says the
6 committee that had been convened reviewed articles,
7 studies and other documents, heard presentations from a
8 variety of experts, including tobacco industry
9 scientists, on the subject of the FTC test method for
10 determining tar, nicotine and carbon monoxide levels in
11 US cigarettes. We have deliberated with the goals of
12 answering questions and making recommendations. Our
13 deliberations centered around the following three
14 summary questions. You see that?
15 A. Yes.
16 Q. And the second question that they deliberate
17 on should constituents other than tar and nicotine and
18 carbon monoxide be added to the protocol?
19 A. Yes, I do.
20 Q. If you flip over to the next page, Roman
21 Numeral II, see?
22 A. You want me to ignore everything in between?
23 THE COURT: Don't ask him a question.
24 MR. WAGNER: I just want you to focus on the
118
1 constituents which are what you discussed in connection
2 with your label for the hypothetical cigarette.
3 A. I understand.
4 Q. And Roman Numeral II the committee says with
5 regard to the second question, the committee recommends
6 that in order to avoid confusing smokers, no smoke
7 constituents other than tar and nicotine and carbon
8 monoxide be measured and published at the present time;
9 that was the committee's conclusion, right?
10 A. As written here, yes.
11 Q. Now --
12 A. In December 6th, 1994.
13 Q. As of that time that was the conclusion of the
14 expert committee, correct?
15 A. Correct.
16 Q. Okay. And now I am done with that line of
17 questioning, your Honor.
21 MR. WAGNER: Q. Dr. Harris, for your opinion
22 that Marlboro Lights could be more harmful, that was
23 based upon the Massachusetts testing protocol, correct?
24 A. Yes in the first instance based on my analysis
121
1 of the results of the Massachusetts Benchmark Study.
2 Q. Okay. And the Massachusetts Benchmarking
3 Study assumed that there would be some vent blocking of
4 cigarettes, and that's why consumers would take in more
5 smoke than on another protocol such as the FTC test
6 method, correct?
7 A. Let me phrase it accurately. The
8 vent-blocking protocol has the predicted effect that
9 they would take in more smoke than under the FTC
10 protocol.
11 Q. The way in which they dealt with that was to
12 block, I think you said, fifty percent of the vent holes
13 when they were conducting the test?
14 A. Yes.
15 Q. The question of vent blocking has been
16 studied, correct?
17 A. Yes, it has.
18 Q. And it has been studied extensively, for
19 example, by Lynn Kozlowski?
20 A. Yes.
21 Q. You are familiar with Lynn Kozlowski?
22 A. Yes.
23 Q. And Lynn Kozlowski presented a chapter or
24 wrote a chapter for Monograph 13?
122
1 A. Yes.
2 Q. And you are familiar, are you not, with Dr.
3 Kozlowski's conclusion that vent blocking appears to be
4 a significant mode of compensation for reduced yields
5 among smokers of lowest-tar cigarettes but not likely
6 among most smokers of light cigarette brands, correct?
7 A. Did he reach that conclusion?
8 Q. That's the first question. Did he reach that
9 conclusion?
10 A. You would have to show me the document; I
11 don't recall that specifically.
12 Q. I am going to show you -- it is the last full
13 paragraph, page 28 of Monograph 13.
14 A. I see that paragraph. He did write that.
15 Q. Okay. Do you have any basis to disagree with
16 Dr. Kozlowski's conclusions?
17 A. I don't feel informed right now about that
18 literature that he reviewed in that document enough to
19 dispute it or agree with it.
20 Q. Okay. I am going to give you another
21 document. This is defense 4141, your Honor. Dr.
22 Harris, 4141 is the log of the output of your
23 statistical analysis in this case, correct?
24 A. It looks like it, yes.
123
1 Q. And from this data isn't it true that in
2 addition to running tests on a per-milligram basis, you
3 also ran the same type of calculations on a per-
4 cigarette basis?
5 A. That is correct. In fact --
6 Q. That's fine.
7 A. Correct. I could point to you where --
8 THE COURT: Just answer the question.
9 MR. WAGNER: Q. If you turn to page 4, which
10 is 4141.4, it will carry over to page 5, but that is a
11 table of the mean values of the specific constituents
12 per cigarette under the Massachusetts protocol, correct?
13 A. Yes. If I am permitted to say when those
14 cigarettes were smoked all in the same way according to
15 the Massachusetts protocol, please stop me.
16 Q. Understood. This is your analysis on a per-
17 cigarette basis, correct?
18 A. Correct.
19 Q. And we could blow up the table. We see four
20 columns on your data. And we see MLHP, that stands for
21 Marlboro Lights hard pack, right?
22 A. Correct.
23 Q. And MLSP, Marlboro Lights soft pack?
24 A. Correct.
124
1 Q. MRHP refers to Marlboro Regular or Reds hard
2 pack, right?
3 A. Correct.
4 Q. And MRSP would be Marlboro Reds soft pack,
5 right?
6 A. Correct.
7 Q. It takes a little bit of eyeball gymnastics.
8 If I wanted to compare brand packing to brand packing, I
9 would compare Column 1 Marlboro Light Hard Pack to
10 Column 3, Marlboro Regular Hard Pack, right?
11 A. If you wanted to look at the hard packs only,
12 yes.
13 Q. If I wanted to look at the hard packs only,
14 and here you have a list on a per-cigarette basis of the
15 yields of all of the constituents you were talking about
16 in your direct testimony, correct?
17 A. Correct.
18 Q. Okay. And if we start going down the list, we
19 see for these constituents you are going to have to help
20 me. Take, for example, just constituent number one,
21 MSNH3?
22 A. That's mainstream ammonia, high-school
23 chemistry for ammonia.
24 Q. If we compare the value you calculated for
125
1 Marlboro Light hard pack, it's less than the value for
2 the Marlboro Red hard pack, right?
3 A. Am I permitted to say yes but with a proviso?
4 Q. I know you have done this testing every
5 cigarette exactly the same way. My question to you is
6 your statistical analysis on this table that is
7 presented on page 4 of your data shows that Marlboro
8 Lights hard pack on a per-cigarette basis generated less
9 of that constituent than Marlboro Red hard pack, right?
10 A. Yes, provided that the cigarettes were smoked
11 the same way that is zero compensation.
12 Q. For Marlboro Light soft pack it is less than
13 the comparable value on a per-cigarette basis for the
14 Marlboro Red soft pack, right?
15 A. Yes, although that difference would not be
16 statistically significant. I could point you --
17 Q. That wasn't the question. If we start going
18 down the list, we see that that same relative
19 relationship holds for the vast majority of the
20 constituents tested, right?
21 A. Yes.
22 Q. Now, you did talk in your testimony about
23 complete compensation, right?
24 A. Yes, I did.
126
1 Q. So, in order for -- in other words, and you
2 testified that partial compensation might be enough to
3 equalize certain constituents, right?
4 A. Would be enough, yes.
5 Q. But you will agree with me that if
6 compensation is partial, as you have defined it, then
7 the smoker would, in fact, be getting lower tar and
8 nicotine, right?
9 A. At least lower tar and likely lower nicotine
10 per cigarette, correct.
11 Q. If, in fact, we are focusing on tar, there is
12 a table in which you gave the tar yields under the
13 Massachusetts protocol, correct, on page 2, 4141.2.
14 And if you could --
15 A. Yes, correct.
16 Q. And those are the mean results for Marlboro
17 Lights, Marlboro Regulars, both hard pack and soft pack
18 under the Massachusetts protocol for tar yield, correct?
19 A. Per cigarette per tar yield.
20 Q. Tested on the machine under the Massachusetts
21 protocol, correct?
22 A. Correct.
23 Q. And in each case Marlboro Lights hard pack,
24 for example, delivered less tar than Marlboro Red hard
127
1 pack; correct?
2 A. Yes, that is what the table says. I will
3 stop.
4 Q. Also says, Dr. Harris, that Marlboro Lights
5 soft pack delivered less than Marlboro Red soft pack
6 when tested under the Massachusetts protocol, correct?
7 A. Correct.
8 Q. And it is also your opinion, is it not, that
9 the Massachusetts parameters overall reflect human
10 smoking patterns more accurately than the FTC
11 parameters, correct?
12 A. That was the position of the MDPH and other
13 bodies, yes, I wrote that in the --
14 Q. So the answer is yes?
15 A. Yes.
16 Q. You do believe?
17 A. I think that is reasonable, yes.
18 Q. Now, you have testified and put in expert
19 reports in many cases. We have gone over that, and in
20 those cases you articulated a theory that you called the
21 innovation effect, correct?
22 A. Yes, not in this case but in other cases I
23 have talked about what is called the innovation effect.
24 Q. In those cases you were positive this
128
1 innovation effect that Philip Morris USA and other
2 tobacco companies could have and should have embodied a
3 host of advanced techniques to reduce risks faster,
4 right?
5 MR. WAGNER: That's all I have with respect to
6 this portion of your opinions, and I guess we will see
7 you next week when it comes to economics.
8 A. Thank you very much, Mr. Wagner.
9 THE COURT: Redirect.
10 REDIRECT EXAMINATION
11 BY: MR. SWEDLOW
12 Q. Dr. Harris, who did the testing upon which you
13 based your analysis in the Massachusetts Benchmark
14 Study?
15 A. The constituent testing the four cigarette
16 manufacturers: Philip Morris, Lorillard, RJ Reynolds,
17 Brown & Williamson.
18 Q. And you relied on the accuracy of that testing
19 in doing your secondary analysis, is that correct?
20 A. That's correct.
21 Q. Did you, in rendering your expert opinion, as
22 stated here today, did you rely upon any of your
23 twenty-five years of experience in specifically studying
24 smoking and health issues as they relate to cigarettes?
130
1 A. Yes.
2 Q. Did you rely upon any of your training as a
3 medical doctor in order to render the opinion that you
4 have rendered here today?
5 A. Yes.
6 Q. Did you only number crunch in order to render
7 your opinion here today?
8 A. In the sense in which that is used in the
9 common vernacular, no.
10 Q. I wanted to go back to something that Mr.
11 Wagner raised, and that was the per-cigarette
12 comparison. The Massachusetts benchmark Study smoking
13 protocol, is that any more accurate than any other
14 smoking protocol at measuring the comparative smoking
15 behavior of smokers between products?
16 A. No, it doesn't address comparative smoking
17 behavior because, by definition, it is -- the machines
18 smoke all the cigarettes the same way. It does not
19 allow one machine to smoke one brand of cigarette in a
20 different way than another, an issue that is relevant
21 when we compare human smokers.
22 Q. And why didn't you then offer to the Court the
23 per-cigarette comparisons that were lifted out of the
24 electronic spread sheets that you provided to defense
131
1 counsel in comparing the levels of these constituent
2 toxins?
3 A. For the reason that the per-cigarette yield
4 reported in my data sheets represented a constant
5 smoking condition across cigarettes and did not take
6 into account the well-documented phenomenon of
7 compensation. The results show the differences between
8 what machines get and not the differences between what
9 genuine smokers get.
10 Q. Do you --
11 A. Per cigarette.
12 Q. Were you finished?
13 A. Yes.
14 Q. Do you know if Philip Morris, in measuring the
15 relative harm or, excuse me, in the process of measuring
16 the relative harm of cigarettes has measured constituent
17 toxins on a per-milligram delivery basis?
18 A. Yes, it has.
19 Q. How do you know that?
20 A. I have reviewed research documents authored by
21 Philip Morris that are in the public domain in which the
22 yield of cigarette known smoke toxins in cigarettes are
23 computed or compared on a per-milligram tar basis.
24 Q. I would like to hand you a document, and I
132
1 would like you to tell me how you first became aware of
2 the existence of this document?
17 MR. SWEDLOW: Q. Just so we have this on the
18 record as a question and answer, where did you find this
19 document?
20 A. I found it on the Internet at the Philip
21 Morris PMDOCS.com.
22 Q. Just for reference purposes, this will be
23 marked as Exhibit 85, but it is not yet marked. What
24 does --
133
1 THE COURT: 86.
2 MR. SWEDLOW: 86, I'm sorry. Q. What does
3 this document show, if you can describe it for us?
4 A. This document is a graphical display of the
5 comparative yields of various toxic cigarette
6 constituents on a per milligram of total particulate
7 matter, TPM, basis for two cigarettes. One being Accord
8 and the other being something called a reference or
9 research cigarette, whose code name is 1R4F.
10 Q. What is Accord?
23 A. Accord is one of a number of cigarettes or
24 cigarette-like devices intended to heat rather than burn
134
1 tobacco. And it has been developed by Philip Morris,
2 and I believe may be test marketed in the United States
3 now.
4 Q. What, as you understand it, based upon your
5 study of smoking and health as it relates to cigarettes,
6 is the purpose, or the stated purpose, for the Accord
7 cigarette?
8 A. To reduce the deliveries of certain toxic --
9 designated toxic agents by heating tobacco and,
10 therefore, avoiding the chemical processes of combustion
11 and pyrolycis present in conventional cigarettes that
12 are widely regarded as important in the generation of
13 these toxic substances.
14 Q. Does this list here reflect an overlap with
15 the list that was utilized by the Massachusetts
16 department of Public Health?
17 A. Yes, a substantial overlap.
18 Q. This key here, can you explain what is
19 reflected in this key?
20 A. I think it is reasonable interpretation that
21 the bars are either black and white or color coded to
22 reflect different categories of toxic agents, in some
23 cases, for example, human carcinogen, benzene, cadmium
24 and arsenic, obviously, are in that list, as well as
135
1 vinyl chloride, 4-aminobiphenyl.
2 There is a drop to a footnote one; that is a typo;
3 they meant that, clearly, any scientist would know that
4 that meant IARC, International Agency for Research and
5 Cancer, which I referred to before, and the other
6 categories, likewise, talk about other classes of toxic
7 agents.
8 MR. WAGNER: Your Honor, there is no
9 foundation. I think Dr. Harris testified he has made
10 assumptions, Philip Morris document speaks for itself.
11 THE COURT: I can't tell by the colors unless
12 he knows, see if he knows the colors would otherwise be;
13 they are not indicated here.
14 MR. SWEDLOW: Let me back up for a second. The
15 point I am trying to make is not the point that these
16 identify specific levels, let me just ask the question
17 that I was laying the foundation for. Based upon your
18 review of this document, is it your opinion that Philip
19 Morris, when comparing the relative harm of cigarettes,
20 also measures constituent toxins on a per-milligram
21 delivery basis?
22 A. Yes.
23 Q. We were discussing, or you were discussing
24 with Mr. Wagner, that in the first instance your opinion
136
1 was based upon the Massachusetts Benchmark Study, and I
2 want to ask you, is there other -- are there other
3 pieces of evidence that converge to form your opinion on
4 the relative harm of a Marlboro Light cigarette compared
5 to a regular Marlboro cigarette?
6 A. Indeed, yes.
7 Q. Let me ask you generally. Is there any
8 evidence that you have considered that exists today that
9 demonstrates to you that a regular Marlboro, excuse me,
10 that Marlboro Lights is less harmful than a regular
11 Marlboro?
12 A. Less harmful?
13 Q. Yes.
14 A. No.
15 Q. Is there any evidence that demonstrates to you
16 that a Marlboro Light is more harmful than a regular
17 Marlboro?
18 A. Yes.
19 Q. What is the group of evidence on the side of
20 the scale that a Marlboro Light is more harmful than a
21 regular Marlboro?
22 A. As I articulated before, the results of my
23 analysis of the Massachusetts Benchmark Study,
24 epidemiological studies in which the rising incidence of
137
1 adenocarcinoma has been attributed by many scientists to
2 changing patterns of smoke inhalation due to the
3 introduction of ventilated cigarettes and data to which
4 Dr. Farone has testified concerning the increased
5 genotoxicity of ventilated cigarettes, including
6 Marlboro Lights, produced by Philip Morris. That is the
7 tests were produced by Philip Morris.
8 Q. If I understand your testimony correctly,
9 there is no evidence that exists today that a Marlboro
10 Light is less harmful than a regular Marlboro, but there
11 is a group of evidence that the Marlboro Light is more
12 harmful than a regular Marlboro; is that correct?
13 MR. WAGNER: Objection, leading.
14 THE COURT: Overruled.
15 A. I would say -- I'm trying to be careful as a
16 scientist; I would say there's no direct evidence. One
17 might try to draw an inference that if filter --
18 THE COURT: Let's start over. I am lost. I am
19 going to sustain his objection now because the way he
20 responded confused me.
21 MR. SWEDLOW: Is there any direct evidence that
22 a Marlboro Light is less harmful than a regular
23 Marlboro?
24 A. In those categories overall analysis of
138
1 constituent yield, epidemiology and genotoxicity
2 testing, I know of no direct evidence that the Marlboro
3 Light would be less toxic or would reduce harm in
4 comparison to Marlboro Red.
5 Q. (By Mr. Swedlow) Is there any direct evidence
6 that a Marlboro Light is more harmful than a regular
7 Marlboro?
8 A. Again, with respect to those categories of
9 evidence, the answer is yes.
10 Q. When you were speaking here at this 1994
11 National Institute of Health committee meeting, or
12 whatever this meeting was, this large transcript that we
13 saw, the first sentence of what you read was, and I will
14 read it to you again on page 88. Likewise, toxicity
15 studies in nonhuman species can also give estimates of
16 relative risks, and to coin a phrase used by Mr. Wagner,
17 was that true then?
18 A. Yes, that was true then.
19 Q. Is that true today?
20 A. Yes.
21 Q. And we went over this ad nauseam on your
22 direct testimony. So I will just ask you the general
23 testimony, is it your opinion that in order to determine
24 the relative risk or harm from a product, you need to
139
1 consider a convergence of the evidence or weight of the
2 evidence?
3 MR. WAGNER: Objection, leading.
4 THE COURT: Overruled.
5 A. Yes.
6 MR. SWEDLOW: Q. Based upon the convergence
7 of the evidence or weight of the evidence of the
8 relative harm of a Marlboro Light and a regular
9 Marlboro, it is your opinion that a scientific consensus
10 has not yet formed on that issue; is that correct?
11 A. Yes, scientists would -- applying scientists'
12 standards, no such consensus has been formed.
13 Q. But applying weight of the evidence standards,
14 is it your opinion that evidence exists that Marlboro
15 Light is more harmful than a regular Marlboro?
16 MR. WAGNER: Object to that, his testimony
17 would be offered as an expert opinion reasonable degree
18 of scientific certainty not some weight of some
19 evidence, and the Doctor has stated there is no
20 consensus on the point.
21 MR. SWEDLOW: I can restate the question. Is
22 it your expert opinion based upon your twenty-five years
23 experience studying smoking and health as it relates to
24 cigarettes specifically, to a reasonable degree of
140
1 scientific certainty, that there is more direct evidence
2 of Marlboro Lights being more harmful than a regular
3 Marlboro?
4 MR. WAGNER: Objection, lacks foundation.
5 THE COURT: Overruled.
6 A. May I say it my own way? I am not -- I will
7 try to agree with your question but phrase it --
8 THE COURT: No, no, just give your --
9 A. I didn't understand your question.
10 Q. (By Mr. Swedlow) Go ahead and answer the
11 question, in your own words, answer the question.
12 A. There is reliable scientific evidence that
13 would be accepted, to a reasonable degree of scientific
14 certainty, supporting the proposition that Marlboro
15 Lights is more harmful than Marlboro Reds to the human
16 smoker, but I know of no scientific evidence, direct
17 evidence, to a reasonable degree of scientific
18 certainty, that would support the contrary or converse
19 proposition that Marlboro Reds are more toxic than
20 Marlboro Lights.
21 MR. SWEDLOW: I have no further questions.
22 MR. WAGNER: I just have a few follow up.
23 RECROSS-EXAMINATION
24 BY: MR. WAGNER
141
1 Q. You were shown this document about the Accord
2 cigarette. Put your mind back where you were. Now, the
3 Accord cigarette, as you understand it, is called a
4 non-conventional cigarette; right?
5 A. Correct.
6 Q. And you understand there is a difference
7 between conventional and nonconventional cigarettes,
8 right?
9 A. Correct.
10 Q. You understand that the Accord scientifically
11 and technologically is a very recent development,
12 correct?
13 A. Absolutely not.
14 Q. The Accord has been marketed only recently by
15 Philip Morris, correct?
16 A. But as a technological development, it goes
17 back to the sixties.
18 Q. And you understand that Philip Morris had to
19 develop certain technology and obtain patents on that
20 technology, correct?
21 A. There, indeed, are patents involved; the
22 underlying concept is decades old.
23 Q. The underlying concept as opposed to a
24 commercially-available product marketed as Accord,
142
1 correct?
2 A. If you want to exclude other products marketed
3 in the 1980's, yes; literally true that Accord is
4 Accord.
5 Q. Now, whether by Accord or by any other
6 cigarette, Marlboro, Marlboro Lights and with respect to
7 the delivery of certain constituents: tar, nicotine or
8 the other constituents you mentioned, you have done no
9 test to determine the yield actually delivered to Class
10 members; have you?
11 A. No, I have not studied any individual Class
12 member.
13 Q. So you don't know and cannot testify as to
14 what tar and nicotine yields or yield of any constituent
15 Class members received when smoking full-flavor
16 cigarettes, correct?
17 A. I think that I can testify with reasonable
18 accuracy about comparative yield but not the specific
19 number of milligrams or micrograms for any identifiable
20 individual.
21 Q. Similarly, you have done no test on Class
22 members to determine the specific amounts of tar and
23 nicotine or other constituents ingested when they smoked
24 Marlboro Lights or Cambridge Lights, correct?
143
1 A. Again, I can only make population-based
2 comparative statements, but I have done no investigation
3 that would allow me to conclude that Smoker A got a
4 certain number of micrograms of acrolein from Marlboro
5 Lights.
6 Q. At the conclusion of the Redirect Examination
7 you were talking about whether or not you have any
8 evidence that Marlboro Lights confer reduced risk or
9 less harm, you recall those questions?
10 A. Yes, I do.
11 Q. And you said that you have no such evidence,
12 correct?
13 A. No direct.
14 MR. SWEDLOW: Objection. I think he reversed
15 it there; there no such evidence.
16 MR. WAGNER: Of reduced harm.
17 MR. SWEDLOW: For Marlboro Lights.
18 MR. WAGNER: That's what I said. That's what I
19 meant to say if I didn't. I am trying to put your mind
20 back, you recall those questions, correct?
21 A. Yes, and I answered no direct evidence.
22 Q. That's your view as of today, correct?
23 A. That is correct.
24 Q. That has not always been your view, has it?
144
1 A. That is correct.
2 Q. In the past you have stated in expert opinions
3 you filed with courts, for example, that low-tar
4 cigarettes do confer some reduction in lung cancer risk,
5 correct?
6 MR. SWEDLOW: I'm going to object, and we have
7 a line of these objections. We just jumped from lights
8 to low tar without defining low tar, and my objection is
9 the vague use of that term low tar.
10 THE COURT: Sustain that.
11 MR. WAGNER: Q. Dr. Harris, when you were
12 giving your opinions, you included Marlboro Lights in
13 the group of low-tar cigarettes to which you were
14 referring; correct?
15 A. Yes. When I offered opinions that there was
16 epidemiological evidence of a reduced lung cancer risk
17 of low-tar cigarettes, then given my understanding at
18 the time, I would have included Marlboro Lights in that
19 group.
20 Q. And it wasn't until April of 2001 in the Blue
21 Cross trial that you then became aware of some new
22 evidence that challenged your prior view; correct?
23 A. That's not correct. I knew of the evidence
24 scientifically for some time; that was the first time I
145
1 was asked it in the legal system.
2 Q. You became aware of a new report issued by the
3 Institute of Medicine in February 2001 that challenged
4 the view that low-tar cigarettes had any health benefit,
5 whatsoever; correct?
6 A. Correct.
7 Q. And you described the revelation from that
8 report, as well as other things that you were learning,
9 as an expert witness's honest acknowledgment of new
10 scientific data that challenges previous conclusions;
11 correct?
12 A. Correct.
13 MR. WAGNER: Thank you very much. Appreciate
14 your time, Doctor.
15 MR. SWEDLOW: Your Honor, I would like to offer
16 -- I have one question if I may.
17 THE COURT: Go ahead.
18 RE REDIRECT EXAMINATION
19 BY: MR. SWEDLOW
20 Q. In your prior expert opinions referenced
21 vaguely in the Recross there, would you include in your
22 epidemiological analysis of relative harm a regular
23 Marlboro in the low-tar category when concluding that
24 low-tar cigarettes may have reduced harm?
146
1 A. I am not sure I can parse your question.
2 Right now I would not conclude that low-tar cigarettes
3 reduce harm. I don't think that I have found reliable
4 scientific evidence to that effect. At the time that I
5 did a prior literature review, I thought that there was
6 evidence, but it is clear that from a number of sources
7 of data, some of which Mr. Wagner asked me about, that
8 proposition is no longer correct.
9 MR. SWEDLOW: I would like to offer into
10 evidence a couple of things I forgot to offer in before.
11 One is Group Exhibit that was previously marked as 85.
12 It is the presentation materials from Dr. Harris's
13 Direct Examination.
10 laid out when these issues were brought up by Dr. Farone
11 apply to Dr. Shields as well. Above and beyond, this
12 has been his work for his entire lifetime. He can speak
13 to it directly. The mutagenicity goes to the consumer
14 fraud as a way of showing that these cigarettes, the
15 so-called light cigarettes were not better; in fact,
16 they were worse. And this is one way that we are going
17 to show that, all be tied into the consumer fraud
18 claim.
19 THE COURT: In that context, overruled.
20 MR. LOMBARDI: Your Honor, may I have a
21 standing objection to the whole line of testimony to the
22 extent it is using mutagenicity in ways I described in
23 my objection?