February 12, 1998
STATE OF MINNESOTA
DISTRICT COURT COUNTY OF RAMSEY
SECOND JUDICIAL DISTRICT
File No. C1-94-8565
The State of Minnesota, by Hubert H. Humphrey, III, its attorney general, and Blue Cross and Blue Shield of Minnesota,
Plaintiffs,
vs.
Philip Morris Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson Tobacco Corporation, B.A.T. Industries P.L.C., Lorillard Tobacco Company, The American Tobacco Company, Liggett Group, Inc., The Council for Tobacco Research-U.S.A., Inc., and The Tobacco Institute, Inc.,
Defendants.
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THE CLERK: All rise. Ramsey County District Court is now in session, the Honorable Kenneth J. Fitzpatrick presiding.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Good morning.
(Collective "Good morning.")
MR. HAMLIN: Good morning.
(Collective "Good morning.")
JONATHAN M. SAMET called as a witness, being previously sworn, was examined and testified as follows:
BY MR. HAMLIN:
Q. Good morning, Dr. Samet.
Dr. Samet, yesterday we talked about the Doll and Hill case-control study in 1950. Do you recall that?
A. Yes, I do.
Q. I've placed on the easel Trial Exhibit 30161, which is a summary of that study. I want to direct your attention to the results column, and we see that cigarettes are measured in the results column; for example, one to four, five to 14, 15 to 24, 25 to 49, and 50. Now is that the number of cigarettes smoked per day?
A. Yes, that's right. That column refers to broad groupings -- groupings of the numbers of cigarettes smoked per day. So, for example, 15 to 24 would take in those persons who reported smoking in the range of 15 to 24 cigarettes per day.
Q. And how many cigarettes are in a pack?
A. Twenty are in a pack typically.
Q. And that measure of cigarettes per day is also in the other studies that we talked about yesterday?
A. We saw very similar groupings of data yesterday, that's correct.
Q. Doctor, I want to turn now to the subject of the types of lung cancer, and I want to direct your attention to Trial Exhibit 30073, which is a picture of a small-cell carcinoma. Can you find that, please?
A. Yes, I have it.
Q. All right. And can you tell me whether that picture accurately portrays a small-cell carcinoma?
A. Yes, this is a representation of the visible aspects of such a carcinoma, as well as a microscopic appearance.
MR. HAMLIN: Your Honor, we would offer Trial Exhibit 30073 for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive 30073 for illustrative purposes.
BY MR. HAMLIN:
Q. Dr. Samet, we now have the exhibit on the overhead, and can you describe for the jury and the court what we see?
A. Yes. Let me just say first that there are a number of types of lung cancer, four principal types, the small cell is one of the types, and it's called "small cell" because in fact the cells just look small and they're somewhat uniform.
This type of lung cancer accounts for approximately 20 percent of cases of lung cancer. It's a cancer that tends to arrive -- arise in the tubes of the lung, in the major airways, the bronchi, sort of towards the start of the -- start of the lung, and it is a tumor that tends often to present with both signs of blockage of one of the tubes, the bronchi, but unfortunately it also tends to spread early and quickly, and in fact in terms of treatment it's considered to be metastatic at the time of diagnosis just by definition.
So what the -- the spot shows is simply a massive tumor, the white, that has filled the lung, and then you can see in the -- let me just --
Q. Yes, why don't you come down and use the laser pointer. Might be more effective.
A. Just if you can see here, this would correspond to the mass of the cancer. And then here, beneath where the trachea divides into the two bronchi, are lymph nodes, which is often a site to which cancer spreads, and this would represent such lymph nodes.
And then over here we just simply see what one would see under a microscope looking at tissue from such a cancer. And the x-ray just shows what one would see on the chest x-ray of an individual who had a cancer of this type. Here would be the mass of the cancer itself, and probably some collapse of the lung behind the tubes that has been blocked by the cancer.
Q. Doctor, what are the symptoms that a patient presents with small-cell carcinoma?
A. Well, the symptoms from small-cell carcinoma would likely reflect what is happening locally, where the cancer has usually arisen in the airway, in the tube, and blocked the tube, so there might be cough, coughing up blood, chest pain, then signs from the spread of the cancer. This -- this cancer, as I've said, tends to spread early and aggressively, so some of the common sites affected are often the brain, the bones, where people would experience bone pain, the adrenal glands may become filled with cancer and people actually develop insufficiency of the adrenal glands. There may just be generalized weakness. And there's some very special metabolic problems that may occur with this -- this type of cancer.
Q. Doctor, what are -- what are the other types of cancer, lung cancer that is?
A. The other types of lung cancer are often referred to as just non-small- cell cancer, because clinically there's an important distinction in treatment, but the other three principal types of non-cell -- non-small-cell lung cancer are called squamous-cell cancer, adenocarcinoma, and large-cell carcinoma.
Q. Doctor, I want to direct your attention to Trial Exhibit 30070. Do you have that?
A. Yes, I do.
Q. And that is a picture of a squamous-cell. Let me ask you whether that is an accurate portrayal of a squamous-cell carcinoma?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30070 for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive 30070 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, first of all, let me ask you this: What percentage of all lung cancers is squamous-cell?
A. This type of lung cancer, squamous-cell, accounts for approximately 20 to 25 percent of lung cancer cases at present.
Q. And where does -- where does it arise in the body?
A. This -- this -- this type, like small cell, tends to arise very centrally within -- within the lung, so within the first three to four to five generations of the tubes that are branching in the lung, the bronchi. So this one tends to be somewhat nearer to the trachea than some of the other types.
Q. Can you point out on the exhibit where the squamous-cell carcinoma is?
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Perhaps you can come down and use the laser pointer to do that.
A. It's a --
Again here we simply see the same kind of representation as on the last, with again the trachea, the dividing into the right bronchus. And then these types of cancers tend to arise very early in the divisions of the airways as they move out to the alveoli. So as shown in -- in this image here, which is what one might see through a bronchoscope, there is a tumor mass actually obstructing the airway, which again would lead to symptoms such as cough or coughing up of blood. And then on the x-ray, we can see a tumor mass which is sitting right centrally within the lung, which is a relatively characteristic sort of appearance for this type of tumor.
Q. Doctor, you mentioned a bronchoscope. Can you give us a little more detail about what a bronchoscope is and what it's used for?
A. Yes. Again as I -- as I mentioned yesterday, typically diagnosis of lung cancer is made by -- during a bronchoscopy or sometimes by passing a needle under x-ray or other guidance into the lung. With the bronchoscope, a flexible tube is passed down through the voice box into the lung and -- and the bronchoscopist, typically a pulmonary physician, can actually visualize the tubes within the lung and, passing down small forceps or brushes, take small bites or cells from suspicious areas or visible cancers. With a cancer like this, from the appearance, one would have little doubt just by seeing it what -- what it would turn out to be with biopsy information.
Q. Doctor, referring once again to the exhibit, can you tell us what we see in the x-ray --
A. Yes.
Q. -- which is in the lower left-hand portion of the exhibit?
A. In the -- in the x-ray, again, we're just looking at here the mass that would be the tumor sitting right adjacent to the root of the lung.
Q. Doctor, you testified that another type of small-cell carcinoma is adenocarcinoma?
A. Of non-small cell.
Q. Excuse me. Non-small, non-small.
Can you turn to Trial Exhibit 30072.
A. Yes.
Q. Do you have that?
And is that an accurate representation of an adenocarcinoma?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30072 for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive 30072 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, what percentage of lung cancers is represented by adenocarcinoma?
A. Well this type has been rising in frequency over the approximately last 25 or 30 years, now accounts for about 30 percent of lung cancers in the United States.
Q. I want to direct your attention to the exhibit which is on the overhead, and can you tell us where the adenocarcinoma is located in this exhibit?
A. So unlike the two types of lung cancer we were just talking about, the small-cell and the squamous-cell, the adenocarcinomas tend to arise more out to the periphery of the lung, as shown on this illustration, where you can see the tumor mass is now out to the edge of the lung, the white sphere out here.
Q. And what are the symptoms of adenocarcinoma?
A. Well the symptoms are -- the symptoms are varied. One presentation is sometimes just to find such a picture on -- on x-ray, but more often symptoms come from local problems, cough, coughing up blood, as we talked about for the other types of cancer, or sometimes these cancers can erode through the lung and actually enter the sac, the pleura that surrounds the lung, they can actually move beyond that and invade into the ribs and chest, causing chest pain, the appearance of a mass, or like the other types of cancer, they can spread to different sites, what are called metastases. So another presentation would be with metastasis to the brain or perhaps to the bones.
Q. Doctor, could you turn to Trial Exhibit 30071. Is that an accurate depiction of a large-cell carcinoma?
A. Yes, it is.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit 30071 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30071 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, what percentage of lung cancers is represented by the large-cell carcinoma?
A. The large-cell is a little less frequent than the other types that I've been talking about. Large-cell accounts for about 10 percent of all lung cancers.
Q. Directing your attention to the exhibit that is on the overhead, can you show us the location of the large-cell carcinoma?
A. Okay. I -- I think again in -- in this illustration we can see a large tumor mass. In fact, large-cell carcinomas tend to be somewhat peripheral like the adenocarcinomas, and they also tend to present as large masses, although the name of the tumor comes from its cellular appearance of having large cells, not from the large mass with which it usually presents.
Q. You said that the large-cell carcinoma tends to be peripheral. What do you mean by "peripheral?"
A. Okay. So we saw, for example, with the squamous-cell, that there was a mass right next to where the lung originates, next to the heart. With this type, the large-cell, and as we saw for the adenocarcinoma, it's more out towards the edge of the lung, towards the periphery of the lung.
Q. Doctor, are there curative treatments for lung cancer?
A. Really depends on the type of lung cancer and the stage at which the lung cancer has presented.
Q. Let's talk about small-cell.
A. Okay. As I said before, in thinking about treatment clinically we divide lung cancer into small-cell and non-small-cell. That's because small-cell, as I said, we consider to be metastatic at the time of diagnosis, and that's because over the years through clinical experience we've learned that this is a very aggressive tumor, it spreads very early in its natural history, early in its course because the cells are so aggressive. They move throughout -- throughout the body, so that surgery is not the right treatment, because taking out the cancer mass in the lung still leaves all these cells that are present throughout the body, even if they can't be seen. So the treatment for small- cell cancer of the lung is the combination of chemotherapy and radiation.
Current treatment for small-cell cancer would include very intensive chemotherapy, usually four drugs, and then because the brain is one of the sites to which these cells spread, the treatment protocol also usually involves whole-brain irradiation. So there's a very difficult course of chemotherapy plus irradiation of the brain, and with that, you know, there's only a small percentage of patients who end up surviving five years with this disease.
Q. What if any side effects are there from chemotherapy?
A. Well this is a --
Chemotherapy courses are very demanding, they make people sick, they make their hair fall out, and there are any variety of potential complications. You knock down the body's own immune responses. The people having chemotherapy are at risk for infection, bleeding, and many other complications.
Q. What side effects are there from radiation?
A. Well again, people receiving brain irradiation are obviously affected, they're sick. The swelling of the brain that can occur during the radiation can affect their function. These are very difficult treatments.
Q. Doctor, based on your clinical experience, what do these treatments generally cost?
A. Well, I think "a lot" is the simple answer to that.
Q. Can you give us a range?
A. I -- we're talking about thousands and thousands of dollars.
Q. Doctor, let's now turn to curative treatments for non-small carcinoma. If we could have the non-small carcinoma on the overhead.
What is the preferred treatment?
A. Well for the -- for the non -- for the non-small-cell cancers, unlike the small-cell, the approach is surgery, so that for those persons with cancer that is limited at the time of diagnosis to one area of the lung, hopefully it may be possible to surgically resect the involved part of the lung; that is, take out that piece of lung. Or sometimes for larger tumors, or depending on the location, it may be necessary to take out the entire lung. That's a procedure called pneumonectomy.
Q. Doctor, what if any problems can arise in performing surgery on a lung cancer patient who is a smoker?
A. Well, first of all, this is very serious surgery. Any time one opens the chest -- chest cavity and begins to remove lung, this is high risk, although, fortunately, with modern surgical techniques, risks are lower than -- than before.
The concern in operating on individuals who have smoked is that they're at greater risk for complications. For example, in thinking about taking out one lung, one has to know -- the surgeon and the physicians have to know how affected the remaining lung might be by chronic obstructive pulmonary disease because smokers are at higher risk for heart disease. There may be greater risk for complications following surgery from coronary heart disease.
Q. Based on your clinical experience, what is the range of cost for surgery of this sort?
A. Well again, major surgical procedures are just simply very expensive.
Q. Doctor, can you tell me whether radiation is ever used with non-small carcinoma?
A. Sometimes radiation is used for very localized non-small-cell carcinomas, particularly adenocarcinomas, in individuals who may not be able to have surgery, perhaps because their lungs are -- are already damaged from smoking, but more often radiation is reserved for treatment of the distant spread and local complications of the cancer rather than any attempt to actually cure the cancer.
Q. Now we've been talking about curative treatment. Are there other kinds of treatment for those who can't be cured?
A. For -- for those who can't be cured of lung cancer, which constitutes the majority, they have a variety of what we call palliative treatments. These are treatments to try and maintain the quality of life for as long as possible for those who have the cancer. These are treatments to help control pain and other complications of the lung cancer, its spread, or local complications.
Q. You used the word "palliative." What do you mean?
A. Well here we're really talking about a variety of different types of therapies that might be needed. For example, to treat a blocked bronchus with pneumonia behind it, radiation might be used in an attempt to open up the passage. For someone with bone pain from metastasis, radiation might be used in an attempt to destroy the tumor that is within the bone. Pain control is a very important part of the management of the lung cancer patient and -- and very often requiring very skilled use of pain-relieving medications, sometimes, towards the end, the use of continuous IV, intravenous narcotic drips to maintain pain and allow the individual with lung cancer to maintain themselves in -- in comfort. And then because there may be so many other complications of the -- of the disease, pneumonia for -- for example, difficulty eating, a whole variety of supportive care may be needed.
Q. Can this care require entry into a hospice or a nursing home?
A. Yes. Very often, as persons with lung cancer become more ill, they may -- may need a level of care that is not possible in the home. Such persons might enter a hospice program, they may go to a nursing home so that they can have the full-time care that is needed to essentially keep them comfortable.
Q. Based on your clinical experience, how much do these treatments cost?
A. I think cost can simply mount as these -- the days over which such intensive care is needed mount.
Q. Doctor, what are the survival rates for lung cancer?
A. Right now in the United States, five-year survival is around 12 percent; that is, of 100 people who are diagnosed with lung cancer, five years later about 12 or so, approximately, will be alive.
Q. What is the leading cause of cancer death in men in the United States?
A. Lung cancer.
Q. What is the leading cause of cancer death in women in the United States?
A. Lung cancer.
Q. How many people died in 1996 from lung cancer?
A. We're at approximately 160,000 deaths per year in the United States right now from lung cancer.
Q. How many people died in the United States in 1950 from lung cancer?
A. Approximately 18,000.
Q. So in percentages, what is that increase?
A. Approximately -- approximately a nine-fold increase.
Q. Okay.
A. Eight-fold.
Q. Has the Surgeon General of the United States found that smoking causes lung cancer?
A. Yes.
Q. When?
A. 1964.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty that smoking causes lung cancer?
A. Yes, smoking causes lung cancer.
Q. Now as part of your work in this case, have you also investigated whether smoking causes other cancers?
A. Yes.
Q. Doctor, if you would, could you come down and list on the flip chart those other cancers.
Let me ask you whether you investigated laryngeal cancer?
A. Yes, I did.
Q. You can you write that on the board, please.
Did you investigate oral cancer?
A. Yes, I did.
Q. Can you write that on the chart.
Did you investigate esophageal cancer?
A. Yes, I did.
Q. Can you write that on the chart.
Did you investigate cancer of the pancreas?
A. Yes.
Q. Can you write that on the chart.
Did you investigate bladder cancer?
A. Yes, I did.
Q. Can you write that on the chart.
Did you investigate kidney cancer?
A. Yes.
Q. Can you write that on the chart.
Now is that a complete list of the cancers that you investigated in this case, apart from lung cancer?
A. Yes.
Q. Thank you.
MR. HAMLIN: Your Honor, I've placed a trial exhibit number on the chart, trial exhibit number is 25021, and plaintiffs would offer this chart for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 25021.
BY MR. HAMLIN:
Q. Doctor, directing your attention to Trial Exhibit 25021, the first cancer that is listed there is laryngeal cancer. Could you describe that disease for us, please?
A. Yes. The larynx, of course, is the voice box, so we're referring to cancer on the -- in the voice box, typically involving the vocal cords, then other structures, possibly, within the larynx.
Q. Doctor, for illustrative purposes, why don't we use the model. So if you could come down and point out on the model where the larynx is located.
A. Okay. It's just a reminder that the passage of air to the lungs from the nose and the mouth is through the back of the throat, into the larynx or voice box, which is sitting right here, and then connects to the trachea, which is the tube that brings the air on down to the lungs.
MR. HAMLIN: You can go back.
(Witness resumes the witness stand.)
Q. Could you describe that disease.
A. Yes. As I've said, this is a disease that involves the larynx or the voice box. The cancers begin to grow in the cells lining the surface of the -- of the larynx. Typically individuals who have this might notice that their voices become hoarse or change, they may have cough, they may cough up blood because the tumor itself becomes somewhat irritated, and another way that they might notice is they might notice a lump in the neck from a spread of the cancer to the lymph glands that are in -- in the neck.
Q. Could you describe the treatments for laryngeal cancer.
A. Treatment can involve surgery, removal of part of the larynx, removal of one of the vocal cords, depending on the stage of the cancer, how -- how far spread the cancer is at the time of diagnosis. It can involve removal of the entire larynx or voice box, leaving people to need to find other ways to speak, learning to speak using esophageal speech or devices. The treatment can also include radiation as a part of the management.
Q. Based on your experience as a clinician, how much do these treatments cost?
A. Well again, we're talking about either major surgery or radiation, so typically costly.
Q. Let's go to the -- the next cancer on Trial Exhibit 25021, and that's oral cancer. Could you describe that disease. And once again, perhaps you can refer to the model.
A. Okay. I think just from here, I think by "oral cancer" I'm referring to cancers that arise in the mouth and in the throat. Okay. And these are cancers that typically present with symptoms related to the growth of a mass of cancer within those areas. So people may experience pain, they may notice a mass, they may have difficulty swallowing, or, as in the case of cancer of the larynx, they may notice a lump in the neck because of spread of the cancer into the lymph glands.
Q. Can you describe for us the treatments that are used for oral cancer.
A. Again, the -- the treatment here is typically surgery, and often very radical surgery to remove the involved cancer, often involving a dissection of the lymph glands of the neck to try and remove any cancer-containing lymph glands. This -- there may be need for major reconstruction, it all simply depends on the stage at which the tumor is found.
Q. Based on your experience as a clinician, how much do these treatments cost?
A. Again, major surgery and follow-up and care and so forth would be costly.
Q. Let's go to the next cancer on the list, that's esophageal cancer, and could you describe that disease.
A. Right. The esophagus, of course, is just the tube that connects the mouth and throat to the stomach. It passes through the chest, actually behind the heart. Esophageal cancers arise in the cells that line the esophagus, and again the symptoms occur when a mass of cells has grown big enough, the cancer has grown big enough to cause symptoms, pain on swallowing, difficulty swallowing, difficulty swallowing foods, or there may be complications as the tumor spreads beyond the esophagus and growing into the surrounding organs, like the lungs or the blood vessels that are sitting right behind the esophagus.
Q. What kinds of treatments are used to treat esophageal cancer?
A. Well this is a very serious and difficult cancer to treat, in part because of the location and in part because very often by the time it's diagnosed, the tumor is difficult to take out and has spread beyond the esophagus into the local tissues. Treatment usually -- treatment to attempt to cure would involve, again, radical surgery with resection of the esophagus in an attempt to remove all of the tumor mass.
Q. Based on your clinical experience, how much do these treatments cost?
A. Well again, surgery for esophageal cancer is a major undertaking, and costly.
Q. Let's go to the next cancer on the list, which is cancer of the pancreas. Could you describe that cancer.
A. Right. The pancreas is the secretory organ that we saw yesterday sitting at the back of the abdomen. It's the organ that makes digestive enzymes and insulin. It can be the site of growth of cancers. These cancers are often very difficult to find and diagnose, although with modern methods of imaging, the CAT scan, we can do a much, much better job now.
Typically persons who develop this type of cancer have symptoms as the cancer grows and spreads beyond the pancreas; back pain, for example, is a very common symptom because the cancer begins to involve the abdominal wall or to move towards the spinal cord. It can also affect and block the passage of the bile out of the liver so some persons present with jaundice; that is, they've turned yellow from the backup of by-products.
Q. What treatments are used to treat cancer of the pancreas?
A. Well unfortunately, most people who present with this are -- usually have too advanced a cancer to be -- to be treated. For those who can be treated, the approach is a very radical form of -- of surgery involving removal of the pancreas or much of the pancreas, and some reconstruction of the tubes, if you will, within the -- within the abdominal cavity.
Q. Based on your clinical experience, how much do these treatments cost?
A. Well again, the curative treatment involves major surgery, and for those who need palliative care, this will be costly.
Q. The next cancer on the list is bladder cancer. Could you describe that disease for us, please.
A. Right. The -- the bladder, of course, is just situated at the bottom of the abdominal or peritoneal cavity. This is, of course, where the urine is stored. The bladder cancers arise in the cells that line the bladder, and again, symptoms occur essentially when the tumor has become big enough to disturb the flow of urine to cause blockage or perhaps to bleed so that there is blood in the urine, but the other way that the cancer might be diagnosed is as it spreads beyond the bladder, perhaps causing pain or complications in other adjacent organs.
Q. What treatments are used to treat bladder cancer?
A. The treatment depends on the stage of the disease and how aggressive the disease is. For some of the lower-grade cancers it may be possible to use primarily local treatments. For the more radical or more aggressive types of cancer, typically treatment would involve removal of the bladder and perhaps local removal of lymph nodes surrounding the bladder.
Q. Now you mentioned "radical treatment." Would that involve surgery?
A. That would be surgery, yes.
Q. You also mentioned "local treatment." Now what do you mean by that?
A. By that I would actually mean treatment of the cancer using methods such as laser or other local treatments actually applied to the bladder cancer without removing the bladder.
Q. Now based on your experience as a clinician, are local treatments expensive?
A. Well again, typically this would involve treatment and follow-up over time, perhaps retreatment, so yes, costs would mount.
Q. Based on your experience as a clinician, what are the costs of the more radical treatments, such as surgery?
A. Well again, with removal of the bladder we're talking about major surgery and associated costs.
Q. Doctor, the last cancer on the list is kidney cancer. Could you describe that disease.
A. Okay. Of course the kidneys, as we saw yesterday, are sitting in the back of the abdominal cavity, the right and left kidneys. There are several types of kidney cancer, cancers involving the body of the kidney itself, and then cancers in the tubes that essentially channel -- take the urine out of the kidney as it's formed and guide it towards -- move it to -- to the bladder. These cancers can arise in both of these areas of the kidney.
Again, the symptoms occur when the cancer has become big enough to cause problems locally, pain, blood in the urine, perhaps blockage of the flow of urine out of one of the kidneys, or spread of the cancer beyond the kidney into either tissues around the kidney, or metastasis, and kidney -- some types of kidney cancer tend to metastasize fairly early, so there might be metastasis to the lungs or perhaps to the brain.
Q. Doctor, what kinds of treatments are used to treat kidney cancer?
A. For those cancers that are found early enough, taking out the kidney would be the surgical approach.
Q. Are there other kinds of treatments?
A. Again, some -- some forms of chemotherapy might be used with kidney cancer, but the approach -- the approach to cure would be removal at an early stage, and then again palliative treatments might be necessary for those who cannot be cured.
Q. Based on your clinical experience, how costly are these treatments?
A. Again, surgery is certainly costly, and maintaining palliative care, dealing with the complications that -- that arise from an untreatable cancer would be costly.
Q. Doctor, did you conduct an investigation of the scientific literature regarding whether smoking is a cause of these diseases that are listed on Trial Exhibit 25021?
A. Yes, I did.
Q. Did you review the articles that we previously identified as being on the computer database?
A. Yes, I did.
Q. Did you review Surgeon General's reports?
A. Yes, I did.
Q. Doctor, which of these diseases has the Surgeon General determined are caused by smoking?
A. Well, let's see, starting, I guess, from the top, laryngeal cancer, oral cancer, esophageal cancer, bladder cancer.
Q. Okay. Now has the Surgeon General reached a conclusion with respect to cancer of the pancreas?
A. Yes. Also --
Well the Surgeon General has not reached the final causal conclusion on pancreatic cancer.
Q. What does it mean that the Surgeon General has not reached a final causal conclusion about a particular disease?
A. Well some of the Surgeon General's reports have commented on the evidence of pancreatic cancer and smoking. When I described the Surgeon General's reports earlier, I said that the reports do not every year take a look at all of the evidence on smoking and disease. The last report specifically on the topic of cancer was 1982. So in part, the Surgeon General's reports not listing a disease as caused by cancer may simply reflect the timing of the reports in relationship to how the evidence has grown since the prior report.
Q. When the Surgeon General considers a disease, how does the Surgeon General do that? Is there a system that is in place?
A. Well the reports have come out over the years on varied topics. The reports of the 1980s touched on a number of specific diseases: 1982, cancer; 1983, heart disease; 1984, lung disease. But there's not been, to my knowledge, a plan for every-year review or every-other-year review or some time basis to look at the evidence.
Q. And to your knowledge, has there been a systematic review of the evidence with respect to pancreatic cancer by the Surgeon General?
A. Well the last time that cancer was touched on specifically as -- as a topic, as I mentioned, was 1982.
Q. Now the fact that the Surgeon General has not reached a conclusion, what does that mean about whether there is a causal relationship?
A. Well it certainly does not mean that there is not a causal relationship, and in fact other organizations have reached a causal conclusion on, for example, pancreatic cancer.
Q. And which organization or organizations have reached that conclusion with respect to pancreatic cancer?
A. The International Agency on -- International Agency for Research on Cancer, the World Health Organization, has reached that conclusion.
Q. Now you also mentioned that the Surgeon General has not reached a conclusion regarding kidney cancer. Has any other organization reached a causal conclusion regarding kidney cancer?
A. Yes. Again the International Agency for Research on Cancer in its 1986 report reached the conclusion that smoking caused one of the types of kidney cancer that I mentioned, the type that involves the -- the tubes, the structures that collect the urine within the kidney and channel it out of the kidney. And in fact in the 1995 update of that report by Richard Doll, who chaired it, he concluded that the evidence was now sufficient that smoking was a cause of the other type of kidney cancer that I mentioned, that of the body of the kidney itself.
Q. Doctor, what do we know about how smoking causes the cancers that are listed on Trial Exhibit 25021?
A. Well I think on that exhibit there are really two types of cancers that we might think about, those like the larynx or the mouth and in part of the esophagus, where the smoke is coming directly in contact with the surfaces where the cancers will arise. So the larynx, the voice box and the mouth, just like the lung, would be sites where the smoke would be inhaled and the carcinogens in the tobacco smoke deposited on the -- on the surface.
The esophagus probably is exposed to the carcinogens in tobacco smoke almost the same way, because the materials that are cleared out of the lung, the mucus that's naturally cleared out of the lung, contains tobacco smoke carcinogens in it, and that material is actually swallowed. We all produce mucus as we cleanse our lungs, and that mucus simply rises up the trachea, it's propelled by little what are called cilia, these are little whip-like objects that move the mucus up the trachea out of the -- out of the lung, and we -- we simply swallow that. So the esophagus would be receiving this material as it's swallowed, so presumably, there's some direct contact there as well.
Then the other cancers are at organs, obviously, that are distant from the lungs, the bladder and the pancreas and the kidney. The bladder is, of course, where the urine sits, and the carcinogens that have now passed through the body would be excreted by the kidneys where exposure to the kidney would occur, and then the urine would be sitting in the bladder with its load of materials related to smoking, including carcinogens.
The pancreas is another gland -- glandular organism, it's an organism -- organ, rather, that makes enzymes as we've said, and again, receiving exposure to carcinogens through the circulation of these materials in the blood. As we saw in the animation yesterday, this material has crossed through the membrane that lines the lung, the alveolar membrane surface, into the capillaries and then spreads throughout the body.
Q. Doctor, I want to show you what has been marked as Trial Exhibit 30152, titled "Known Carcinogens in Tobacco Smoke Identified To Date."
MR. HAMLIN: First of all, Your Honor, I was mistaken yesterday when I said that this is in evidence. This apparently is not in evidence, and we would offer this list as -- as an exhibit now for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive 30152 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, you referred to carcinogens in your -- your answer just now. Can you tell me what the exhibit is that I've just placed in front of you.
A. This is a listing of 71 carcinogens in tobacco smoke, known carcinogens in tobacco smoke, identified by the Hoffmanns, who have worked on the composition of tobacco smoke for many years, in their 1997 article on the cigarette.
Q. And are the carcinogens on this particular exhibit the carcinogens that you were just referring to about carcinogens in smoke?
A. Well these are the carcinogens identified to date, yes. There may be others, not found.
Q. Doctor, did you apply the criteria for causality in the 1964 Surgeon General's report to the diseases that are listed on the chart which has been identified as Trial Exhibit 25021?
A. Yes, I did.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes laryngeal cancer?
A. Yes, it does.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes oral cancer?
A. Yes, it does.
Q. Based on your education, your training and your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes esophageal cancer?
A. Yes, smoking causes esophageal cancer.
Q. Based on your education, your training and your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes cancer -- cancer of the pancreas?
A. Yes, it does.
Q. Based on your education, your training and your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes bladder cancer?
A. Yes, smoking causes bladder cancer.
Q. Based on your education, your training and your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes kidney cancer?
A. Yes, smoking also causes kidney cancer.
Q. Doctor, let's turn now to chronic obstructive pulmonary disease. Could you describe that disease for the court and the jury.
A. Okay. Chronic obstructive pulmonary disease, as I said yesterday, is the name now given to what in the past has been called emphysema often in the United States, or sometimes chronic bronchitis. I'm referring to the irreversible damage to the lung that occurs in a substantial proportion of smokers.
What happens as this disease develops is that smokers lose more lung function than would occur with natural aging. That -- that is because the smoking is causing their lungs to develop emphysema, which means that the alveolar sacs that we saw yesterday within the lung where the gas is exchanged are becoming destroyed and widened, and the lung, instead of having many alveolar sacs, develops larger air spaces, and it loses its elastic properties so that there's difficulty in fact in the lung emptying itself of the air that comes in.
The very small tubes that go out to the alveoli themselves are damaged, they're thickened and they are scarred, and the end result is that the person who is developing chronic obstructive pulmonary disease or has chronic obstructive pulmonary disease loses the ability to move enough air in and out of the lungs to essentially keep up with the normal demands of life. As we do our activities, some things demand more breathing, carrying groceries in from the car, exercising, mowing the lawn or -- or whatever. Persons who develop this disease lose that reserve, and in fact toward the end of the disease they may become so limited that things we all take for granted, like being able to take our -- put our clothes on and off, or even to eat, become too demanding in terms of the breathing capacity. So chronic obstructive pulmonary disease refers to this permanent damage to the lung.
Q. Doctor, what are the treatments for chronic obstructive pulmonary disease?
A. Well unfortunately, once the disease has developed, this damage to the lung is largely irreversible, so simply stopping smoking does not provide anything more than a tiny bit of gain back for some of the smokers. So the treatment is really, then, trying to provide some medications that may have some effect, and we use here some of the same medications that are used with asthma.
Another very important treatment, and one that does help the person who has chronic obstructive pulmonary disease, is oxygen therapy, so often you can see people using oxygen therapy, perhaps out doing -- in the mall or wherever. But we -- for those persons who are more severely affected with the disease, we usually would use continuous oxygen to try and keep the blood level of oxygen where it should be, because the disease will have lowered the level of oxygen in -- in the blood. So that's the principal treatment.
There are some other therapies that are now being tried and tested involving surgery, for example, but the mainstays of treatment are oxygen, using some drugs that are very much like the drugs used for asthma, and then, again, working with people who have this disease to try and provide support and help them to maintain their daily activities as much as possible.
Q. Based on your clinical experience, how costly is this treatment?
A. Well the disease has a long course, first of all, often, after -- after diagnose, so people may be under treatment for -- for many years. During that time they will be receiving drugs, oxygen, perhaps at a cost of several hundred dollars a month, they may have hospitalizations because they're vulnerable to the chest colds and respiratory infections that we all normally have, but the person with no lung reserve, those illnesses often result in hospitalization. So the course of this disease can be very, very costly.
Q. How common is chronic obstructive pulmonary disease?
A. Probably rather common. I think what we know now from surveys, studies where we have gone to communities and tried to understand how common the disease is, we learn that perhaps several percent of adults have this disease, and I think right now there are approximately 80,000 deaths a year that are coded to chronic obstructive pulmonary disease.
Q. Did you conduct an investigation of the literature regarding whether smoking causes chronic obstructive pulmonary disease?
A. Yes, I did.
Q. And did you look at the Surgeon General's reports on this issue?
A. Yes, I did.
Q. Did you investigate whether chronic obstructive pulmonary disease met the causal criteria set out by the Surgeon General?
A. Yes, I did.
Q. Let's first talk about the consistency and strength criteria.
Do you have an animation that describes the relative risks for chronic obstructive pulmonary disease?
A. Yes, I do.
Q. Could you play that animation, please.
A. Yes. This animation is like those that we saw yesterday, showing the results of the various epidemiological studies in our database. Remember these are relative risk values. One is the value for never smokers. We're looking at information for men, describing the relative risk for current smokers compared to never smokers for developing chronic obstructive pulmonary disease. And looking at the data, the studies going from the '50s up to the present. And again, as we saw yesterday, the plane has been set at one, the value for never smokers. Just for reference, ten, or a one-thousand-fold increase in risk, shown on this plane. And you can see the results of a number of individual epidemiological studies, all consistently showing increased risk, some showing very, very strong risks, well above ten, or the 1,000 percent mark.
Q. Doctor, you mentioned "risk." Now what -- what are you referring to when you say "risk?"
A. Okay. Again, I'm referring to the relative risk; that is, how much the risk for the smoker -- for smokers is increased beyond that of never smokers here. So these are relative risk values. Of course by definition for the never smokers, the value is one.
Q. And can you tell us whether there is a trend with respect to relative risk from the years represented on this animation, which I believe go from 1955 to 1995?
A. Approximately.
Well I think if there is a general trend, it would be that over time we're seeing a rise in these relative risk values.
Q. Doctor, could you now turn to Trial Exhibit 30098. Do you have that in front of you?
A. Yes, I do.
Q. That's a demonstrative exhibit titled "Relative Risk of COPD by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers."
Doctor, what is the source of the data for this exhibit?
A. This exhibit shows the --
Q. I'm just asking what the source of the data is.
A. Okay. This -- this exhibit is based on the epidemiological studies that have been included in the database of studies examined for this case.
MR. HAMLIN: Your Honor, at this time we offer Trial Exhibit 30098 for illustrative purposes.
MR. GARNICK: No objection, Your Honor.
THE COURT: Court will receive 30098 for illustrative purposes.
MR. HAMLIN: Can we have the exhibit on the overhead, please.
Thank you.
BY MR. HAMLIN:
Q. Doctor, first of all, tell us what this graph is.
A. Okay. This graph is similar to some graphs that we saw yesterday showing the findings of individual epidemiological studies, each line showing the relative risk values comparing smokers smoking different numbers of cigarettes per day, as shown on the horizontal axis, compared to never smokers. So the relative risk value -- all the lines start at one, which is the relative risk value for never smokers, and then here we can see, for example, the findings of one individual -- one individual study.
Q. Let me interrupt for just a moment, doctor. Is this study for men?
A. That's correct.
Q. Okay.
A. That's correct. This exhibit is for men.
So here we can see the findings for -- here we can see the findings for one study, showing the relative risk values, and these are simply the points within the individual studies showing the relative risks at different numbers of cigarettes smoked per day. So here we see evidence of dose/response; that is, rising relative risk with the number of cigarettes smoked per day for developing chronic obstructive pulmonary disease.
Q. Doctor, do we see a trend here or some significance to the direction of the lines as the number of cigarettes per day increases?
A. Of course this -- this rise is what I mean by the dose/response, so all these lines -- except you'll notice there's an outlying line or two, we sometimes see a little bit of variation in the results of studies, but all -- almost all of the lines show this upward trend of increasing relative risk for chronic obstructive pulmonary disease with the number of cigarettes smoked.
Q. Doctor, could you now turn to Trial Exhibit 30099. Do you have that in front of you?
A. Yes, I do.
Q. This exhibit is titled "Relative Risk of COPD by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers - Women." Can you tell me the source of this graph; that is, the source of the data in this graph.
A. Again, the -- the source for this graph is information contained in the literature review and entered into the computer database.
MR. HAMLIN: Your Honor, at this time plaintiffs offer Trial Exhibit 30099 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive Exhibit 30099 for illustrative purposes.
MR. HAMLIN: Can we have the exhibit on the overhead.
Thank you.
BY MR. HAMLIN:
Q. Doctor, can you tell us the title of the exhibit first?
A. The title of the exhibit is "Relative Risk of COPD by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers - Women."
Q. And can you describe for us the two axes of the graph.
A. Okay. Again, this graph is very much like the other graphs that we've seen, the vertical axis showing the relative risk for COPD comparing current smokers to those who have never smoked, the horizontal axis is the number of cigarettes smoked per day. And again, each line corresponds to one epidemiological study, the findings of one epidemiological study.
Q. And can you tell us, basically, what is depicted on the graph itself.
A. Again, here we see the general rise of the relative risk values for chronic obstructive pulmonary disease in women for those who currently smoke by the number of cigarettes smoked per day. So with each increase, for example, in this study in the number of cigarettes smoked per day by the participating women, the relative risk rises.
Q. Doctor, do we have an animation for COPD for women?
A. Yes, we do.
Q. Can we turn to that.
A. This is simply another animation showing the values -- relative risk values for current smokers compared to never smokers for chronic obstructive pulmonary disease in women over the time period 1970 to 1990. You'll notice there's fewer bars on this animation than on some of the others. This just -- the fact that there are fewer bars just means that there have been less studies of women and chronic obstructive pulmonary disease.
So here we only have one, two, three, four, five, six, seven, eight individual studies shown, and again we can see the consistency among these studies in all showing increased relative risk for current smokers compared to never smokers in women.
Q. And are the studies that are depicted in this graph in the database?
A. Yes, they are.
Q. Doctor, let's talk about the criterion of specificity. Is that -- has that criterion been applied by you to the evidence of COPD?
A. Well again, specificity in the Surgeon General's criteria refers to the idea of a very specific link between some exposure, smoking, and disease; that is, smoking only causes one disease and that disease is only caused by smoking. As I mentioned yesterday, that does not apply very well to smoking which causes many diseases, and some of the diseases caused by smoking have a number of causes.
Now for chronic obstructive pulmonary disease, smoking is in the United States far and away the predominant cause, and at this point some of the other causes, serious childhood infections, for example, in the past, or some very- high-level industrial exposures, are very rare, fortunately. So chronic obstructive pulmonary disease is really -- by far, the substantial majority of the cases are caused by cigarette smoking.
Q. Can you tell me whether the criteria of temporality is met by the evidence here?
A. Yes. Again, temporality just meant that smoking should come before the development of the disease. In the -- in the case of chronic obstructive pulmonary disease, this is a disease that takes a number of years of smoking before it occurs. The lung is actually a remarkable organ with a great deal of reserve, and that reserve has to be eroded away by the damage caused by years of smoking before this disease develops. So typically the disease is almost not seen before age 40, except under very unusual circumstances, and we begin to see, as clinicians, persons presenting with this disease perhaps in the decades of the fifties and beyond. So at that point the smoker may have been smoking for 30 or 40 years. So temporality is clearly met here. There's a substantial time of smoking before the disease develops.
Q. Let's talk about the final criterion, which is coherence. What evidence is there of coherence?
A. Well again we have a number of lines of evidence to think about with regard to coherence. First, chronic obstructive pulmonary disease has become a much more common disease. The mortality, the number of deaths from chronic obstructive pulmonary disease is rising all the time still. I mentioned that I think we're at about 80,000 deaths or so at this point from this disease. I think in the state of Minnesota that number is somewhere around a thousand right now. So we've seen a rise in this disease across the century approximately parallel but lagging behind the way that smoking began earlier in the -- earlier in the century.
We -- we also have a good knowledge of the ways in which smoking can act to cause chronic obstructive pulmonary disease. This is a disease that arises because the various factors that can damage the lung in smokers are out of balance. In a sense, the enzymes that are naturally within the lung that are there to protect the lung against bacteria, particles that come in, are overly activated, and in fact some of the normal control mechanisms for these enzymes are themselves suppressed by the action of smoking.
So what we see in the lungs of smokers is that there are many what we call inflammatory cells. These are cells that themselves can secrete products, make products that can damage the lung. And the lungs of the smokers are just primed for injury, and it's this unchecked injury going on year after year after year as the smoker smokes that can lead to damage.
We -- we also have some other evidence. There have been many studies where we've made observations on how lung function changes over time in smokers and non-smokers. All of us, as we -- as we age, somewhere beyond about age 30 we begin to lose a little bit of lung function. Every year there's a little bit of loss. But as I said, the lung is a remarkable organ, it has substantial reserve, and so those of us who don't smoke can tolerate that loss. But smokers lose lung function at a faster rate, some at a very fast rate, so that by age 50 or perhaps beyond that they've run out of reserve, and that's when chronic obstructive pulmonary disease develops.
We will know that if we can identify smokers early enough and if they stop, that faster rate of drop actually goes back to that for the never smoker. Okay? But when we actually find somebody with COPD, it's really too late for smoking cessation to have much impact.
THE COURT: Counsel.
MR. HAMLIN: Yes, Your Honor.
THE COURT: We'll take a short recess.
MR. HAMLIN: Please. Yes.
THE CLERK: Court stands in recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
MR. HAMLIN: Thank you, Your Honor.
BY MR. HAMLIN:
Q. Dr. Samet, in your response before the break you mentioned lung function and its decline. What do you mean by that?
A. By -- by "lung function," I'm referring to tests of how well the lung is working, and the test that we most often do is simply to ask people to take a deep breath, fill their lungs up, and blow all the air out as fast as they can, and what we do is measure how much air is blown out, the total, and how fast the air comes out. And that's what I mean by "lung function."
And when I talked about what happens with aging, we lose some lung size and also we lose some of the -- we begin to see some slowing of how fast the air -- the air actually comes out. So those are the sort of two things that are consequences of normal aging. Now both of those are accelerated in people who smoke; there tends to be a greater loss of lung size and the amount of air that can be blown out, and also there is a slowing, a greater slowing of how fast the air can be blown out.
So when I talked about the decline being more in smokers than in non- smokers, I meant that this -- these age declines of how much air the lung holds and can be blown out and how fast it can be blown out are actually worse in smokers compared to non-smokers.
Q. Doctor, I've placed on the easel Trial Exhibit 30155, which has been previously admitted, and the title of that exhibit is "Causal Criteria 1964 Surgeon General's Report," and it is a summary of those criteria.
Doctor, with respect to chronic obstructive pulmonary disease, which of these criteria have been met with respect to the evidence?
A. Okay. Well let me go through the criteria.
First consistency. In study after study we find that smokers compared to non-smokers/never smokers have increased relative risk for developing chronic obstructive pulmonary disease, and also consistently, as we looked at many different groups of smokers, we found this increased rate of loss of lung function that I was just talking about.
Strength, the association is strong in the relative risk values in smokers for developing chronic obstructive pulmonary disease compared to non-smokers; run ten or more, 1,000 percent increase or more. We also see the dose/response, the increasing strength of this relationship as the number of cigarettes smoked per day goes up.
Specificity I talked about before, and I said that for chronic obstructive pulmonary disease, as for the other diseases we will be talking about, specificity is not directly met. Although again, in the United States at this time, there are very few causes of the disease that I'm calling chronic obstructive pulmonary disease other than smoking.
Temporality, easy. People smoke for many years before they develop chronic obstructive pulmonary disease.
And finally, with regard to coherence, we have a great deal of information, the information I talked about on how lung function changes over time in smokers compared to non-smokers. We have evidence that if people stop smoking early enough, that that decline, extra decline goes back to that of the -- rises so that the former smoker only loses lung function as fast as the never -- never smoker. And as I said, we have a great deal of understanding of the processes that are actually taking place in the lungs of smokers that lead to the development of chronic obstructive pulmonary disease.
I also pointed out that this disease, as a cause of death, is rising, and it has become more frequent essentially in parallel to the patterns of smoking across the century in the United States. So again, with regard to coherence, this criterion is met.
Q. Doctor, has the Surgeon General of the United States concluded that smoking is a cause of chronic obstructive pulmonary disease?
A. Yes.
Q. When was that?
A. Well there was a conclusion with regard to -- then the word used was "chronic bronchitis," in 1964; and for various terms including chronic obstructive pulmonary disease, chronic obstructive lung disease, 1984.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes chronic obstructive pulmonary disease?
A. Yes, smoking causes chronic obstructive pulmonary disease.
Q. Let's turn now, doctor, to coronary heart disease. What is your understanding of the term "coronary heart disease?"
A. Coronary -- coronary heart disease refers to disease affecting the blood vessels of the heart itself. The heart is a muscle, it needs oxygen like all muscles, and nutrients, to do its job. The coronary arteries and the blood vessels of the heart bring the blood to the muscles. Coronary heart disease refers to the development of disease within these blood vessels and inadequate delivery of oxygen and other nutrients to the heart muscle itself, and then the clinical consequences of that problem, not getting enough oxygen and sugar and so forth to the heart.
Q. Can you describe the symptoms of the disease?
A. Yes. The symptoms are varied. One very common consequence of coronary heart disease that everyone has heard about is the heart attack. And the heart attack, or myocardial infarction, means that the heart has not received enough oxygen and that heart muscle has actually died. So when we say that somebody has had a heart attack, their coronary arteries have not delivered enough oxygen to the heart, and there's actually been death of some of the heart -- heart muscle. So that's what we mean by a heart attack.
Now sometimes there's not enough oxygen delivered on a temporary basis, and the heart muscle doesn't actually die but there's pain because not enough oxygen has been delivered, and that's what we refer to as angina. Some people might pronounce it as "angina." But that is a problem that people can get that is not actually a heart attack, but is a result of the same problem, not enough oxygen getting to the heart.
And then finally, some people just die suddenly, and that's often thought to be due to coronary heart disease and effects of inadequate oxygen on the heart rhythm itself.
Q. Do you have an understanding of the term "atherosclerosis?"
A. Yes.
Q. What is that?
A. Atherosclerosis refers to the development of what are called plaques, or thickening of the lining of the arteries. The arteries are just tubes that bring the blood to the heart muscle. And by "plaques," I'm referring to thickenings, actually growths on the wall of the artery. And we talk about -- when we talk about atherosclerotic plaques, we're talking about the development of a specific type of thickening that includes some fat, cholesterol within it, as well as some development of scarring, and these plaques can contribute to blocking the flow of blood into the heart muscle.
Q. Can you tell us whether atherosclerosis falls under the category of coronary heart disease?
A. Well atherosclerosis is part of the process involved in coronary heart disease.
Q. Doctor, what are the treatments for coronary heart disease?
A. Well again they're very, very varied. For people who have coronary heart disease, medications may be used to reduce the work load on the heart, to make the muscle not quite be so strained so that its oxygen needs are a little bit less. For people with angina, they may be given medications that increase the circulation of blood in the heart. One common form of medicine that people use on sort of an emergency basis when they're having pain is nitroglycerin. These are pills that people with this disease put under their tongue and they get some immediate increase in the blood flow into the heart.
For -- for people with more advanced disease or with perhaps more serious problems, or depending on the actual plaque and blockages within the heart, they may have what is called angioplasty. That involves placing a -- an actual catheter, a small tube within the coronary arteries, and then there's a balloon on that tube or wire and that balloon is actually blown up to, if you will, open up the blockage. And that's often done now because, using that approach, surgery can be avoided.
For some people surgery is needed, and then they may have what's called coronary artery bypass grafting, and in that type of treatment a blood vessel is taken from somewhere else and actually used to bypass the area of blockage in the coronary artery so the -- the -- this vessel, blood vessel, the graft, by-passes, if you will, the area of blockage. So these are some of the main forms of treatment.
Q. Based on your clinical experience, how much do these treatments cost?
A. Well again, of course, there's a range from nitroglycerin up through coronary artery bypass grafting, and these major surgeries are, of course, quite expensive. Even going through the angioplasty, having a balloon break up the blockage, involves what are called coronary arteriograms, having pictures taken of the coronary arteries, placing this catheter device. It involves hospitalization and is expensive. Of course, the long-term treatment with any medication and follow-up visits with a specialist is -- involves cost.
Q. Did you conduct an investigation of the literature regarding whether smoking is a cause of coronary heart disease?
A. Yes, I did.
Q. And did you look at the Surgeon General's reports?
A. Yes, I did.
Q. And did you investigate whether coronary heart disease met the criteria for cause as set out by the Surgeon General?
A. Yes, I did.
Q. Let's talk about the first two criteria, consistency and strength. Do you have an animation that shows the relative risk for coronary heart disease?
A. Yes, I do.
Q. And I think the first one is for men.
A. Yes.
This is another animation, simply showing the relative risks in different epidemiological studies for coronary heart disease comparing cigarette smokers, men, to non-smokers, and this shows the results of a number of studies done from the 1950s on. Again, the risk for never smokers, the relative risk for never smokers is by definition set equal to one, and then what we can see is the findings of all of these individual studies, all showing increased relative risk that is a value above one, as this problem has been studied in now over almost a 50-year period.
Q. Are the studies that are depicted in this graph in your database and in the literature that you reviewed --
A. Yes, they are.
Q. -- as part of your investigation in this case?
A. Yes, they are.
Q. Do you also have an animation for relative risk of coronary heart disease in women?
A. Yes. This will be the same type of animation. Again the relative risk for women, never smokers is one, and now again we're looking at the findings of a number of studies done out to the 1990s showing the relative risk values. With perhaps one exception or so early on, all the relative risk values for coronary heart disease in women are above one, and you can see that perhaps the highest over here is 7.5 or 750 percent relative increased risk for coronary heart disease in women smokers compared to never smokers.
Q. And this covers a period from 1950 to 1996; is that right?
A. Well the -- you can see where the studies begin, a little bit earlier than 1970 up to the present. This slide --
The animation for men began earlier.
Q. And once again, what is the source of the studies that are depicted on this graph?
A. The source of this information is the -- the studies reviewed and entered into the computer database.
Q. Doctor, can you turn to Trial Exhibit 30100. Do you have that?
A. Yes, I do.
Q. The title of that exhibit is "Relative Risk of Coronary Heart Disease by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers - Men." Can -- can you tell me the source of the data that is depicted in this graph?
A. The data shown in the graph again come from the studies reviewed and entered into the computer database.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit 30100 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30100 for illustrative purposes.
MR. HAMLIN: Can we have that on the overhead? All right.
BY MR. HAMLIN:
Q. First of all, doctor, can you read the title of the graph.
A. Yes. The title is "Relative Risk of Coronary Heart Disease by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers."
Q. And this is for men?
A. Yes, it is.
Q. And can you describe the axes first.
A. Again, the axes here are cigarettes smoked per day by the smokers, begin at zero for the never smokers. And then the vertical axis is the relative risk for coronary heart disease, comparing the current smokers to the never smokers, whose value is one. So all the lines begin at one.
Q. With respect to the cigarettes per day, the graph goes from zero to 50.
A. Yes.
Q. Is that right?
And the relative risk goes from zero to four.
A. That's correct. Although some of the studies go above four, and the numbers -- the relative risk values for those studies are simply written in at the top of the lines.
Q. And in terms of relative risk, what does the figure four mean?
A. The figure four in -- in the example of this graph would mean that the relative risk for developing coronary heart disease is four comparing the current smoker to the never smoker. That is a 400 percent relative increase.
Q. Can you tell us what the lines represent on the graph.
A. As in previous graphs like this, each line is the findings of one epidemiological study, so the points have been plotted out for the persons who have smoked different numbers of cigarettes per day, and these are the relative risk values for those -- for those studies with the individual points just simply connected by the lines.
Q. And what pattern do we see on this graph, doctor?
A. The general pattern is of rising relative risk for coronary heart disease in men as the number of cigarettes smoked per day goes up.
Q. Doctor, let me direct your attention now to Trial Exhibit 30101. Do you have that in front of you?
A. Yes, I do.
Q. And that is entitled "Relative Risk of Coronary Heart Disease by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers," and this is for women; correct?
A. Yes.
Q. And what is the source of the data depicted in this graph?
A. The data come from the studies reviewed and entered into the computer database.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit 30101 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30101 for illustrative purposes.
Q. Once again, doctor, can you tell us the title of this graph?
A. Yes. "Relative Risk of Coronary Heart Disease by Cigarettes Smoked Per Day: Current Smokers Versus Never Smokers - Women."
Q. And could you describe for us the axes of the graph.
A. Again, the axes on these -- on this graph are similar to the last graph, cigarettes per day on the horizontal axis, again zero of course for never smokers, and then the relative risk for coronary heart disease by cigarettes smoked per day.
Now one thing to note on this graph is that the scale goes up to eight, the scale for men went up to four, so the scale here extends to a higher range of relative risk for women than it did for men.
Q. And what do each of the lines represent, doctor?
A. Again, the lines -- each one represents the findings on the relative risks for coronary heart disease in women smoking different amounts of cigarettes per day, going from the lowest group to the highest group.
Q. And what pattern do we see on this graph?
A. The pattern is that with increasing numbers of cigarettes smoked per day, the relative risk tends to rise so that the general pattern of these lines is that they're moving upward.
Q. Can you tell us what some of these specific values are at the top of the graph. It's difficult to read, but I think you can probably read them from your exhibit and notebook.
A. The values at the top of the graph are the -- are relative risk values that are higher than eight. So, for example, the --
Well I think it is visible. The second value, coming over this way with my laser pointer, I'm pointing at it right now, is 9.4 for the women in this study smoking about 30 cigarettes or a pack and a half a day, so that means that these women had a little bit over a 900 percent relative increase in risk for coronary heart disease because they were smoking 30 cigarettes a day or so.
Q. Could we go back now to Trial Exhibit 30100, the men, and could we go to the top of the graph. And you see some values there. Could you tell us what those values are?
A. Well this graph, reading from the left side here to the right side, 8.8, 5.3, 4.8, 5.0 and 5.6.
Q. And what do those values mean to you?
A. Again, these are the relative risk values in these five studies for the groups smoking -- smoking the -- in this case each -- case it's the highest number of cigarettes per day, so, for example, this 4.8, or about a 500 percent relative increase in coronary heart disease, is for persons in that study smoking 20 cigarettes per day or a pack a day, so about a 500 percent increase associated with a pack a day in that particular study.
Q. Doctor, let's go to the specificity criterion in the Surgeon General's report that is listed on Trial Exhibit 30155. Has that --
Based on your review of the evidence, has that criterion been met?
A. Well for -- for coronary heart disease, there's no doubt that there are causes of coronary heart disease besides smoking. Some of those, for example, include having high blood pressure, diabetes, or having a high blood cholesterol level. So specificity not is applicable; we have other causes of coronary heart disease.
Q. Doctor, are there studies that control for other risk factors?
A. Yes. In looking at the effects of smoking and causing coronary heart disease, there are -- are a number of studies, for example the Framingham study, the nurses health study that we examined yesterday, where these factors have been controlled, and then the effects of smoking on coronary-heart-disease risk have been examined.
Q. Doctor, I want to show you Trial Exhibit 30166, which has been admitted into evidence, and this is the board that summarizes the nurses health study. See that?
A. Yes, I do.
Q. All right. And is this the study that you just referred to?
A. That is --
Yes, it is.
Q. Yeah. And are the factors -- the risk factors which are controlled for listed at the bottom?
A. That's correct.
Q. And they include age and time period, Quetelet's index, menopausal status, hormone replacement therapy, family history of myocardial infarction, and personal history of diabetes, hypertension and hypercholesterolemia; is that right?
A. That is -- that is correct.
Q. And when those factors are controlled for, doctor, what effect is there from smoking?
A. Well I think what we can see on this board is that when those factors were controlled for -- and that's the column far to the right that says "Adjusted" with the asterisk, there's a strong dose/response relationship. So the never smokers, zero cigarettes per day, relative risk is one; one to 14 cigarettes per day, 2.3, about a doubling of the risk; 15 to 24, that's about a pack a day, an almost five-fold increase or 500 percent increase in risk for coronary heart disease; and finally for those smoking 25 or more cigarettes a day, a six -- a relative risk value of about six.
And again in terms of could this affect be due to other factors, well here is without control for those factors, and then with the asterisk with control for those factors, showing essentially no change in the relative risk values, and certainly no change in the general pattern of the dose/response.
Q. Doctor, let's go to the next Surgeon General's criterion, which is temporality. Can you tell us whether that criterion has been met?
A. Again that criterion is met. Coronary heart disease, like some of the other diseases that we've been talking about, typically occurs perhaps not quite as -- at quite such older ages as lung cancer and chronic obstructive pulmonary disease. We may see people having heart attacks even in their thirties and forties, depending on -- depending on their own risk factor profile. But we know that smoking has usually gone on for a number of years before people develop coronary heart disease. We usually begin to see this disease rising in occurrence beginning approximately in the late thirties and on. So typically, again, there's been a substantial amount of smoking before we see this disease occur, and so temporality is -- is met.
Q. Let's talk about the last criterion. Can you tell us whether there is evidence of coherence.
A. Yes. We have evidence of coherence from a number of lines of information, what happens when people stop smoking, some of our information on the effects of smoking on the body, different ways that it acts to increase -- the different ways it acts to increase the risk. We also have information on what happens if people continue to quit after they've had a heart attack or myocardial infarction.
Q. Let me direct your attention, doctor, to Trial Exhibit 30102, and that's titled "Relative Risk of Coronary Heart Disease by Number of Years Quit Smoking: Former Smokers Versus Never Smokers - Men." Can you tell me the source of the data that is depicted on that graph?
A. The data on this graph come from the epidemiological studies abstracted into the computer database.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit 30102 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30102 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, again, could you tell us what the title of this graph is?
A. "Relative Risk of Coronary Heart Disease by Number of Years Quit Smoking: Former Smokers Versus Never Smokers - Men."
Q. And can you tell us what the axes of the graph are.
A. Yes. The -- the horizontal axis is the number of years quit smoking. By that we just mean the number of years since somebody stops smoking and stays stopped. So that five means that someone used to smoke and now it's five years since they quit smoking. The vertical axis is relative risk for coronary heart disease, and again never smokers are one on this -- on this graph, and of course zero years quit.
Q. And the graph goes up to 4.0?
A. Correct.
Q. What do the lines represent on the graph?
A. Each lines represent the results of one epidemiological study, and the dots correspond to the specific data points in the study. And again, we've just connected the dots with the lines.
Q. What pattern do we see here, doctor?
A. There's a general pattern of declining risk of coronary heart disease after smokers stop smoking. Some of the reduction is relatively immediate, and then over time, out to about ten or more years, we see the risks still declining.
Q. What if any health benefit is there from smoking cessation with respect to the risk for coronary heart disease?
A. Well there seems to be some relatively immediate benefit within the first year of quitting, and then over time, perhaps within the first five to 10 years, the risks -- the relative risks continue to drop for smokers compared -- former smokers compared to never smokers.
Q. Can we turn now, doctor, to Trial Exhibit 30103. Title of that document is "Relative Risk of Coronary Heart Disease by Number of Years Quit Smoking: Former Smokers Versus Never Smokers - Women." Can you tell us the source of the data in this graph?
A. The data in this graph come from the epidemiological studies abstracted into the computer database.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30103 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30103 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, once again, can you tell us the title of this graph?
A. Yes. "Relative Risk of Coronary Heart Disease by Number of Years Quit Smoking: Former Smokers Versus Never Smokers - Women."
Q. And the axes of the graph are what?
A. As before, the number of years quit smoking for the former smokers, and then the relative risk comparing the former smokers to never smokers.
Q. And what do the lines represent?
A. Each line represents the results of one individual epidemiological study. And again, the dots are just the data points from those studies.
Q. What patterns do we see on the graph, or what -- strike that.
What pattern do we see on the graph, or patterns?
A. Again, there's less data than for the -- for the men, but the general pattern is about the same, a decline in the relative risk for former smokers as the number of years of quitting increases, or the number of years since quitting.
Q. And what does this tell us, doctor, with respect to coherence?
A. Well it gives us some insights into how smoking might be causing coronary heart disease. There may be some immediate effect, and that's thought perhaps to reflect carbon monoxide and its effects on oxygen delivery, and perhaps the pharmacologic effects of smoking, nicotine, perhaps, or other agents within the smoke that may increase the risk for rhythm disturbances of the heart.
Smokers also have blood that tends to clot more easily than the blood of non-smokers. That's because they have higher levels of one of the proteins that clots in the blood, it's called fibrinogen, fibrinogen, and the platelets which stick together to make blood clots tend to be stickier in smokers than in non- smokers. So there seems to be some immediate effects of smoking: the carbon monoxide, some of the effects perhaps on risk for disturbances of the heart rhythm, the heart beat, and then also the general tendency of the blood to -- to clot.
So this is consistent with the pattern in which some of the mechanism by which coronary heart disease is caused by smoking reflects the short-term, immediate responses to smoking.
Q. Has the Surgeon General of the United States concluded that smoking causes coronary heart disease?
A. Yes.
Q. Doctor, with respect to the causal criteria that are set out in the exhibit on the easel, which of these criteria have been met with respect to coronary heart disease?
A. Okay. With respect to coronary heart disease, we've seen very consistent evidence of increased risk across many studies of coronary heart disease in smokers. We've seen that the association varies in strength, it's somewhat weaker in men than in women, but rising up to relative risk values in the range of perhaps, overall, two to 10. We've seen the dose/response relationship increase in strength with increasing numbers of cigarettes smoked each day.
We said that with regard to the criterion of specificity, the coronary heart disease does have causes other than smoking, so that this criterion is not particularly relevant.
Temporality is met. Again it takes some years of smoking before we see the increased risk occurring.
And then with regard to coherence, we have a substantial body of evidence on what happens after people stop smoking and the declining risks, and many effects of smoking demonstrated on the different pathways by which coronary heart disease occurs. So the criterion of coherence has been adequately met.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the scientific literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty whether smoking causes coronary heart disease?
A. Yes, smoking causes coronary heart disease.
Q. Let's turn now, doctor, to stroke. Could you describe that disease for us, please.
A. Yes. Stroke we might think about almost as a heart attack affecting the brain. A stroke occurs when the delivery of oxygen/nutrients to the -- to the brain is inadequate. If this happens on a temporary basis there may be what is called a transient ischemic attack. It's just like what I was talking about when I described angina, except now the organ that's being affected is the brain and not the heart muscle.
But a stroke itself involves the death of some of the brain tissue, the brain cells. That may occur because there's a blockage of blood into that area of the brain because the blood vessels have been narrowed just as we discussed with a coronary arteries. The narrowing may result in the formation of a blood clot on the area of thickening with blockage of the blood supply to that part of the brain downstream from the artery. Some strokes occur with bleeding into the brain, but the -- the net result is that some brain tissue is damaged with death. The brain itself really can't regenerate itself like some other organs can. So the consequences of a stroke depend on how big it is and what part of the brain is -- is affected.
Q. Can you describe some of those consequences for us.
A. Again, what the effects are would depend on which particular part of the brain was affected and which side actually, the left side of the brain or the right side of the brain, because there are different functions on the two sides. One unfortunate consequence is, very often, whether it's the left side or the right side, is the areas that deal with the muscles, with the motor system, with motor control are affected, and then people may -- the stroke victim may end up with weakness in one side of the body or even paralysis in one side of the body, and that's something we call technically hemiparesis, paralysis, or hemiplegia, weakness.
Speech may be affected if the areas of the brain dealing with speech are affected. Vision. Again, our higher intellectual functions can be affected depending on what part of the brain is -- is involved with the strokes. So they're very varied consequences of a stroke.
Q. And what kinds of treatment are used for stroke?
A. Well again that's varied over time. For example, at the moment there are -- the modern therapy is to make some very aggressive interventions to try and reduce the extent of damage initially. But for the person who has had a stroke, much of the attention is really based on rehabilitation, trying to restrengthen weakened arms or legs, to retrain people in how to -- how to talk, to get them back on their feet and functioning as well as they can.
Q. You mentioned "aggressive intervention." What do you mean?
A. Well at -- at -- at the moment we've learned that with some aggressive approaches having to deal -- do with the blood-clotting system, it may be possible to limit some of the damage initially. But this is really a very contemporary approach.
Q. And what are some of the procedures that are used, as you put it, to get people back on their feet?
A. Again, this would typically involve rehabilitation, helping people to, you know, learn to walk or to feed themselves using various kinds of assistive devices, walkers, canes, helping them -- putting them on a program of rehabilitation to strengthen the -- the remaining muscles, to retrain their speech and so on. It really would depend on how the -- what the consequences of the stroke were.
Q. Now doctor, you said that you had clinical experience in working with nursing home patients. Can you tell us what that is?
A. In the -- in the past, early in my -- my career, I had as one of my responsibilities taking care of patients discharged from the University Hospital in New Mexico to nursing homes, and many of those patients had strokes and had gone to nursing homes for rehabilitation, or sometimes just for ongoing care because their care needs were just too much to be done in the home. Then while taking care of patients in the hospital setting, we frequently took care of stroke patients, often needing to discharge them to nursing homes because they needed this rehabilitation or they needed to return to the nursing home environment because they were inadequately functioning to go home. And then we also often saw them come back from the nursing home with the complications of being in the nursing home, sometimes these were bed sores that had developed, sometimes people with strokes have difficulty swallowing, and pneumonia is often a consequence of having food go into the lung instead of down into the stomach. So we frequently saw patients who went to the nursing home and then came back sometimes later with a complication and -- and then were, hopefully, helped and then returned to the nursing home.
Q. Now in your clinical experience, have you seen patients enter nursing homes because of strokes?
A. Yes.
Q. And based on your clinical experience, are these treatments for stroke costly?
A. Yes.
Q. Now did you do an investigation of the literature regarding the causal relationship of smoking and stroke?
A. Yes.
Q. Did you review the Surgeon General's reports as part of that investigation?
A. Yes, I did.
Q. Has the Surgeon General concluded -- has -- strike that.
Has the Surgeon General reached a conclusion as to whether there is a causal relationship between smoking and stroke?
A. Yes, the Surgeon General has.
Q. And what is that conclusion?
A. The 1989 report concludes that smoking is a cause of stroke.
Q. And did you investigate whether the criteria of the Surgeon General's report, criteria that's listed on the exhibit on the easel, have been met?
A. Yes.
Q. And have they?
A. Yes.
Q. Now based on your education, your training, your expertise in the science of smoking and health, and your review of the literature on the science of smoking and health, do you have an opinion to a reasonable degree of scientific certainty as to whether smoking causes stroke?
A. Yes, I conclude that smoking causes stroke.
Q. Doctor, did you also investigate atherosclerosis and aortic aneurisms?
A. Yes, I did.
Q. First of all, can you tell us what those diseases are.
A. Yes. We talked before about how atherosclerosis affects the blood vessels in the heart or the blood vessels leading up to the brain, and atherosclerosis refers to the development of these plaque lesions, growths in the -- in the arteries, and then the consequences of those growths which can include inadequate blood supply to -- to parts of the body downstream from the growth, sometimes, for example, a leg or another organ. These plaques can be spots where blood can clot. The little pieces of plaques can break off and move down and block smaller vessels, arteries downstream from where the plaque is.
Aortic aneurism refers to a problem in the aorta. That's the main tube that takes the blood -- the artery that takes the blood out of the heart and goes down the -- adjacent to the spine, down the back, down through the abdominal cavity, distributing blood to the major organs in the abdomen, and then on to the legs, and an aneurism of the aorta is an abnormal widening of the aorta. At its worst these aneurisms can widen and then essentially burst, which means that unless the leakage is very slow so that it can be stopped, people will -- the person who has this will die. This is just simply the blood will be pumped out wherever the aneurism has been broken through and burst.
Q. Now what are some of the symptoms of these diseases?
A. Variable. Some -- some persons with atherosclerosis may have pain that comes and goes just like we talked about with angina, so there's a condition called -- has a long name -- intermittent claudication. That means people who develop pain typically in the legs when they exert themselves, and that's because the blood supply can't keep up with the oxygen needs of the exercising muscles. There may be blood clots that form on the plaques and cut off the flow altogether. And then we talked about the problem of aortic aneurisms.
Q. What types of treatment are used to treat aortic aneurisms?
A. Aortic aneurism --
Well, ultimately surgery is -- is needed for this condition.
Q. And what about treatments for atherosclerosis?
A. These are quite -- quite variable. It would depend on the amount of the atherosclerosis, where it is, and what the consequences are. There might be medications used or surgical treatment might be needed to remove the blockage or to bypass the blockage.
Q. As part of your investigation in this case, did you do a literature search regarding the relationship between smoking and atherosclerosis and aortic aneurisms?
A. Yes, I did.
Q. And did that search include a review of the Surgeon General's reports?
A. Yes, it did.
Q. Has the Surgeon General of the United States concluded that smoking causes atherosclerosis?
A. Yes.
Q. And has the Surgeon General of the United States concluded that smoking causes aortic aneurisms?
A. Yes. But let me look for the year of that conclusion.
Yes, these were joint conclusions on atherosclerosis and aortic aneurism.
Q. And when was that?
A. That was 1979.
Q. Based on your education, your training, your expertise in the science of smoking and health, and your review of the literature on smoking and health, do you have an opinion to a reasonable degree of scientific certainty as to whether smoking causes atherosclerosis and aortic aneurism?
A. Yes, it does.
Q. Doctor, you have identified another condition caused by smoking called diminished health. What is diminished health?
A. By "diminished health" I'm referring to the general effect of smoking on health status, the generally reported health status of smokers compared to non- smokers, and the general poorer respiratory health of the smoker, including respiratory symptoms and also increased risk for respiratory infections, pneumonia, influenza, and others.
Q. And how are these problems of diminished health manifested?
A. These problems are manifest in many ways, in a general requirement for more medical services, more absenteeism from work, in more respiratory symptoms, in more severe respiratory infections, an increased risk for more severe respiratory infections, and even death from pneumonia and other common respiratory infections.
Q. What are some of the treatments for this condition of diminished health?
A. Well the treatments would be very varied. I have described a general requirement for more medical services. The respiratory conditions might require specific therapy, antibiotic treatment for infections or hospitalization for pneumonia.
Q. Can you give me an example with respect to hospitalization for pneumonia and what kinds of treatment are used in that sort of situation?
A. Well when people are hospitalized with pneumonia, the treatment would vary depending on the severity of the pneumonia, but typically would involve antibiotics. And then if somebody were admitted to the hospital with pneumonia, they might be sick enough to need oxygen, or if they were very sick, they might even need to be placed on a respirator, a breathing machine to provide some assistance to their breathing until the lung recovers.
Q. Doctor, have you done an investigation of the scientific literature regarding whether smoking causes diminished health?
A. Yes, I have.
Q. Could you turn to Trial Exhibit 30109. Do you have that, doctor?
A. Yes, I do.
Q. All right. And is that a table describing the studies that you have reviewed with respect to diminished health status?
A. Yes, it is.
Q. And is it a summary of those studies?
A. Yes, it is.
Q. And are there 98 studies in the database that you compiled in connection with your investigation of this case regarding diminished health?
A. Yes.
MR. HAMLIN: Your Honor, plaintiffs offer Trial Exhibit 30109 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30109 for illustrative purposes.
MR. HAMLIN: Could we put the first page -- it's a little small, so maybe we can start at the top.
BY MR. HAMLIN:
Q. First of all, doctor, this exhibit is titled "Diminished Health Status Summary Table." Correct?
A. Yes.
Q. All right. Can you tell us what each of the columns are going across.
A. Well this table, which is very lengthy, will describe the findings of these approximately 98 studies. For each page we'll see at the top the reference, that's just simply the study, and those are the names of the authors, and the year of the study. There is a description of who the participants were and how many were in the study. And then there is another column labeled "Outcome and Findings." Now there's a variety of different kinds of outcomes and findings, so it was not possible to make uniform entries of these studies into the computer database as we did for some of the relative risk values. So that's why we'll be looking at different kinds of information when we look at this table.
Q. How many --
How many pages constitute this table?
A. There are 28 pages.
Q. Now did you break down these studies by groups?
A. Yes. The studies are broken down into a number of different dimensions of diminished health status.
Q. And I see at the top of the page the capital letter A, and what is next to that?
A. "Medical Morbidity."
Q. And then there's a subheading, what is that?
A. It says "Service Utilization." So this group of entries in the table refers to studies that provide information on how much smokers use -- and non- smokers and former smokers use health care, for example, going to the physician, compared to -- well, for the different groups.
Q. What do --
What do you mean by the term "morbidity?"
A. Okay. Morbidity just refers to general effects on health that are not -- do not lead to death, mortality.
Q. And is the service utilization referred to there health-care service?
A. Yes.
Q. And let's turn, doctor, to the second page, and specifically to the Vogt and Schweitzer study listed about three quarters down the page. That's a 1985 study?
A. That's correct.
Q. And I believe that's in your database as Trial Exhibit 16747; is that right?
A. That's correct.
Q. That's been previously admitted.
And do you have that in front of you?
A. Yes, I do.
Q. Can you tell us about this study.
A. This was a study done in the Kaiser Permanente Health Maintenance Organization or HMO that's in Portland -- in Portland, Oregon. This was a study where about 2500 people, 2,582, had been interviewed about their smoking as well as a number of other factors. And over the time period from 1967 through 1974, their records for use of health-care services in this HMO were -- were examined. And what we're looking at here are the rate -- and I'll explain this -- of use of the hospital for reasons other than obstetric reasons. So this is never smokers, former smokers and current smokers.
Now it says here that this is the rate per something called 1,000 person- years. What that means is it's the rate for 1,000 persons over a year. In other words, for the never smokers, for a thousand never smokers during a year, there were approximately 669 hospital days used. You can see that for the former smokers that number is 704, and for the current smokers that number is 800.
This analysis was adjusted for some factors that might potentially be, what we talked about, confounding, and that includes sex or gender, age, alcohol consumption, and how long the different people in this study had been eligible for the health plan.
Q. And what was the conclusion or the findings of the study?
A. Well this study found that inpatient use as shown here was increased in -- in former smokers and current smokers compared to never -- never smokers. And actually the pattern was somewhat different for outpatient use where former smokers but not current smokers used more outpatient services than non-smokers.
Q. And what was the percentage increase as indicated on the table on the exhibit in the overhead?
A. Well comparing the 669 to the 801, that's an approximate 20 percent increase in hospitalization.
Q. So what you're saying is that the current smokers had 20 percent more hospitalization than never smokers?
A. They had a hospitalization rate that was 20 percent higher than the never-smoker rate.
Q. And what years did this study cover?
A. This was the years 1967 through 1974.
Q. Doctor, could you turn the page, and I want to direct your attention to the Wagner study, which is down at the bottom of the page, and that appears in our -- or in the database as Trial Exhibit 16751, which has been previously admitted. Do you have that study in front of you?
A. Yes, I do.
Q. Now can you tell us, first of all, doctor, about this study, generally what the design was.
A. Okay. This was another study done in a health maintenance organization, this time the health maintenance organization was Group Health, which is a large HMO in the Seattle, Washington area. This -- this --
The investigators, Dr. Wagner and his colleagues, had done two trials of smoking cessation, helping people to quit, and they had documented whether they had been successful in helping -- who they had helped to quit. They had actually measured biomarkers, something we talked about yesterday, to identify those who had really quit. They looked at, then, how much health care was used, what the rate of health-care utilization was in those who continued to smoke and those who quit.
Now the table here is a little bit complicated because what they actually show is how much over the years of the study -- it was a six-year study -- how much those who continued to smoke and how much those who quit, their rate of using health-care services changed every year, so what you want to focus on is that for the quitters, the numbers are negative for the two studies, one was called the free appear clear trial, one was called the breaking away trial. This is outpatient visits, hospital admissions, and hospital days.
So we can see that for the quitters, the annual change in medical care utilization, how much these services, outpatient and in patient, the quitters were using, was dropping every year. And what you can see for those who continued to smoke, the smokers in the two studies, was that there was an increase each year, so that there was a substantial net difference between the quitters who were dropping in their use of health-care services and the smokers who continued to gain in the use of health-care services. So that's what that table is telling us.
Q. And just in summary terms, what was the conclusion of this study?
A. The conclusion was that the successful quitters used less health-care services.
Q. Than -- than whom?
A. Than those who continued to smoke.
THE COURT: All right. Why don't we recess at this time and we'll reconvene at 2:00 o'clock.
THE CLERK: Court stands in recess to reconvene at 2:00 o'clock.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Counsel.
MR. HAMLIN: Thank you, Your Honor. Good afternoon.
(Collective "Good afternoon.")
BY MR. HAMLIN:
Q. Good afternoon, Dr. Samet.
Dr. Samet, do you want to clarify your testimony about when the Surgeon General concluded that smoking caused atherosclerosis and aortic aneurisms?
A. Well I just -- I think there's some ambiguity in the language of the various conclusions, but I do want to note that in 1989 the conclusion was that cigarette smoking was a cause and most important risk factor for atherosclerotic vascular disease.
Q. Doctor, let's return to Trial Exhibit 30109, which is the diminished health status summary table, and I placed the first page on the overhead.
Now we have been talking about the subpart marked "Service Utilization." Do you see that?
A. Yes, I do.
Q. And can you tell me about how many pages that covers in this document?
A. The table itself covers 28 pages, the part on service utilization includes three pages.
Q. All right. Can you summarize for the court and the jury the findings of these studies on service utilization that you have listed in this summary of diminished health status reports.
A. Yes. We looked at two of the studies in particular, the study from Portland and the study from Seattle, both showing how people who smoke use more health-care services than people who did not smoke. The three pages under this section include a number of other studies generally showing, again, this increased demand for health-care services on the part of smokers compared to non-smokers. There's a range of these studies; some were done over 30 years ago, some are more recent, some looked at hospitalizations, some looked at simply going to use -- to see a physician. So there's a variety of outcomes represented here of -- of different kinds of health services.
Q. Doctor, could you turn to page four of the summary. Now this section is titled "Absenteeism." Do you see that?
A. Yes, I do.
Q. Now what do you mean by that?
A. The items included --
The studies included under absenteeism relate to time lost from work due to illness, primarily.
Q. Can you look at the first summary, which appears to be a DHHS summary that I --
Is that the Department of Health and Human Services?
A. U.S. DHHS, U.S. Department of Health and Human Services.
Q. That's a federal agency?
A. Correct.
Q. And that summary is based on the study which is at Trial Exhibit 16746, and that's part of our database?
A. Yes.
Q. First of all, can you explain the design of the study.
A. The information in the table comes from one of the health interview surveys. These are national surveys that are conducted by the government periodically to obtain a picture of the nation's health. The data in this particular table come from the 1977 health interview survey, and the information included in -- in that table comes from thousands of people who have been selected to be representative of the U.S. population.
Q. Doctor, could you go over the columns on that page again. The first one I believe is "Reference." If we can have that on the overhead.
It's on the left. Just says "Reference." Yeah.
A. The layout of the table is --
Q. Yeah.
A. -- like the previous table, so U.S. DHHS, 1980, that's actually just the 1980 Surgeon General's report and the reference to it where the data is contained. This is a sample of U.S. population 20 years and older, and then the findings in the survey are shown in the next portion of the table.
Q. The second column is "Age and Number of Subjects;" is that right?
A. Yes, that's right.
Q. All right. And what do we see under that column for the DHHS survey?
A. Yeah. This is 20 plus in age and this is a sample of persons representative of the U.S. population.
Q. And then the third column is labeled "Outcome and Findings?"
A. That's correct. And this provides the findings of this study.
Q. What are the outcome and findings of this study, as described in this table?
A. Okay. These are then 1977. This is reports of days of work lost due to illness by smoking, current, former smokers, never smokers, men 20 to 44, or 45 to 64, or all; women, total, 20 to 44, 45 to 64. And just for purposes of comparison, the value for current smokers has been made equal to 1.00, and that's why there's just 1.00 down there.
So we're just comparing the proportion of the amount of days lost from work due to illness in the current, former, and never smokers, and what you can see is that the never smokers in comparison to the current smokers generally have values less than one, except in this oldest group of women. So in other words, there's more lost work time in this national study by the current -- the people that are currently smoking at the time they were in the study.
Q. Could we go down to the Halpern and Warner study on that page. It's the third one. Do you see that, doctor?
A. Yes, I do.
Q. All right. And is that also a study in our database?
A. Yes, it is.
Q. And is the study found at Trial Exhibit 16749?
A. Yes, it is.
Q. And can you tell us the age and number of subjects in that study?
A. Yes. Again this -- this is actually now from a later national health interview survey, the 1990 survey, and you can see that these are very large surveys, 119 -- almost 120,000 persons 17 years of age or more were in this study, and this would be a sample selected to be representative of the United States population.
Q. Could you take us now to the next column marked "Outcome and Findings," and you have here a table that has a title. What is that title?
A. The table says "Effect of Smoking Status," and also since this deals with former smokers, "Time Since Cessation on Ability to Work," and then "Odds Ratio," that's just the relative risk value.
Q. Tell us what that title means.
A. Well in this study they've examined how smoking, being a current smoker, or being a former smoker for differing amounts of time not smoking, affects the amount of time reported as away from work lost because of illness or limited ability to work.
Q. And what are the outcome and findings of this study based on this table?
A. Okay. In this study the never smokers are now one, so this is our relative risk value, this is work lost, and the M -- ML means more limitations of ability to work.
Q. And what does that mean?
A. It means that people reported, in response to a question concerning their ability to work, that they had more limitations of their ability to work. So what we see in this is an increased risk for the current smokers, for both of these two measures of ability to work, about a 50 percent increase and about a 27 percent increase. And then in the former smokers you might see that the values are somewhat higher even than in the current smokers, and that reflects that people who are becoming sick with a smoking-related disease, smoking- caused disease, often stop, so not surprisingly they're reporting more limitations because they've stopped because perhaps they've developed one of the diseases that we have been talking about from smoking.
Q. Now, can we go back to the current smokers. You said that current smokers show a 40 -- 48 percent increase in work lost. How did you get that 48 percent?
A. Well this simply would have been calculated by the authors from the data in the report, comparing the relative frequency with which current smokers report work lost time due to illness in the past two weeks compared to never smokers.
Q. So you compare the 1.48 to one?
A. That's right, just as we've done in the other analyses of relative risk.
Q. And does that give you 48 percent?
A. That's correct.
Q. And that's -- that's an increase.
A. Correct.
Q. And if you go to more limitations, how do you calculate a 27 percent increase?
A. Again, the same way. This is a relative risk value, and we're now looking at .27 or 27 percent increase.
Q. Doctor, with respect to the studies that are summarized in the absenteeism section of Trial Exhibit 30109, could you summarize for -- for the court and the jury the findings of those studies.
A. Yes. Again, the general findings among these studies are that people who smoke have more time lost from work, more absenteeism, than those who do not.
Q. Would you turn to page five. The next subpart you have listed here is what?
A. It's entitled "General Health Status."
Q. And could you turn to page seven, and specifically to the Halpern and Warner study. Do you see that?
A. Yes, I do.
Q. Is that one of the studies under this subpart called "General Health Status?"
A. Yes. We also saw this study under absenteeism.
Q. Could we look at the column marked "Outcome and Findings." Perhaps you can tell us about the design of the study and then the results.
A. Well again, this is a study that I already described, the national survey in 1990 of about 120,000 Americans. Here we're looking at self-reported poor health, restricted activity days, and days of illness requiring spending time in bed, again looking at the relative risk for these outcomes, the three, in never smokers, comparing current smokers and former smokers to never smokers. And again what we see here, as with the other reports from this study, is increased risk for these measures in the current smokers, this line, compared to the never smokers, set to one, and then also the former smokers. And again, you can see the tendency for the relative risks to be higher in the former smokers immediately after they've quit; for example, for self-reported poor health, probably because people have quit smoking because of having poor health from smoking.
Q. Now what is the increase for current smokers in self-reported poor health?
A. Well the .62 is equivalent to 62 percent.
Q. If we go to the next column, that's title "Rest Activity?"
A. "Restricted Activity."
Q. Or "Restricted Activity?"
A. Yes.
Q. And what is the increase for current smokers there?
A. The .35 is equivalent to 35 percent.
Q. And then if we go to --
Well first of all, how is "restricted activity" defined?
A. Well these are days on which activity needed to be restricted because of illness.
Q. All right. Let's go to the next column marked "Bed Days." And how is -- how are bed days defined in this table?
A. Again, these would be days in which illness required being in bed.
Q. And what is the percentage increase for current smokers versus never smokers?
A. Approximately 20 percent here.
Q. Now with respect to the studies in the general health status category, can you summarize for us the findings.
A. Yes. Again there's a variety of kinds of studies and measures, and we've only taken a close look at one, but the -- again, the overall findings in these is that smokers compared to never smokers have generally -- generally poorer self-reported health status.
Q. All right. Let's go to page eight of the exhibit. The next category is "Respiratory Morbidity." Do you see that?
A. Yes, I do.
Q. What do you --
What do you understand the term "respiratory morbidity" to mean?
A. Here we're talking about ill health coming from problems with the respiratory tract, primarily the lungs.
Q. And the subpart labeled B1 is "Respiratory Symptoms?"
A. Correct.
Q. And then you further subdivided into "Cross-sectional Studies;" is that right?
A. That's right. And there's another subdivision later.
Q. Well what's -- what is in this first subdivision marked "Cross-sectional Studies?"
A. These are the findings of a number of reports, surveys, on the reporting of respiratory symptoms that would be cough, producing phlegm or sputum, wheezing, and shortness of breath.
Q. Would you turn to page 15 of the exhibit, and specifically to the study at the bottom of the page. And who are the authors of that study?
A. The authors are Dr. Shenker, Speizer and myself.
Q. Now is that the same Dr. Speizer who was your teacher at Harvard in the School of Public Health?
A. Yes.
Q. And what year was the study?
A. The study was published in 1982. The data were collected in 1979.
Q. Can you tell us about the age and number of subjects in this study?
A. Yes. This is a study that was conducted in the area of Western Pennsylvania, approximately 5600 women were included in this study ages 17 to 74.
Q. Now for the record, doctor, this study is found in the database that you have compiled?
A. Yes, it is.
Q. And the trial exhibit number is 16734; is that right?
A. Yes.
Q. Now can you tell us about the design and results of this study.
A. Just briefly, this was a survey, so we just asked questions at one point in time by telephone about whether the women in the study had these symptoms, cough, sputum, coughing up phlegm from the chest, wheezing, and shortness of breath, and we also collected information on their smoking. And we used well- documented standardized questionnaires, survey forms to do this.
Q. And can you tell us what the findings were, and specifically could you refer to the table in the exhibit that's on the overhead.
A. Yes. These are the data for cough, and this is simply the percentage of women who reported having cough at least three months of the year, never smokers, former smokers, and current smokers. And then here we see the proportion or the percent of women having cough at least three months of the year by the number of cigarettes smoked per day; never smokers 5.6 percent, former smokers 7.5 percent, one to 14 cigarettes per day, current smokers 9.1, 15 to 24, about a pack a day, 17 percent, and 25 or more cigarettes a day, about 32 percent of women had cough at least three months of the year.
Q. Doctor, with respect to this subpart identified as cross-sectional studies of respiratory symptoms, can you summarize for us generally what these studies show?
A. Yes. This is some of the studies that have been done that show that people who smoke in comparison with those who do not have higher rates of cough, phlegm or sputum production, wheezing, and shortness of breath.
Q. Could you turn to page 16, doctor, of the exhibit, and specifically to the top of the page. And again, we see Dr. Shenker, Samet and Speizer listed as authors. Is that the same study that we just discussed?
A. Yes, it is.
Q. All right. If we could go to the outcome and findings table. Could you explain to us the significance of this table.
A. Okay. So this is very much like the last table, except instead of saying cough, it now says dyspnea grade three. That just means shortness of breath. And so you can see the percentages of women reporting shortness of breath, again rising from the never smokers to the former smokers, and then again within the current smokers this dose/response for the proportion of women reporting shortness of breath going from 5.6 percent up to 17.6 percent.
Q. Could you turn now to page 18. The next subpart is B1-2. What is this subpart, doctor?
A. This is -- really includes more studies directed at respiratory symptoms, it's just that the study design is somewhat different from the cross- sectional studies that we were just looking at, or surveys, but it's the same type of information as included in the cross-sectional studies.
Q. Well what is a longitudinal case-control study?
A. Well actually there's two types of studies included here, there are cohort studies that we talked about, so there are some studies where the frequency of symptoms was then looked at in relationship to whether people started smoking or stopped smoking during a cohort study, and then there's also some case-control study information here.
Q. Could you help us again with the difference between case-control study and cohort study?
A. Well the cohort studies are the follow-up studies like the British doctors study. The case-control studies are the studies like the early study of Wynder and Graham involving lung cancer cases and controls.
Q. Would you turn now to page 21, to the next subpart. Can you identify that next subpart for us?
A. The next subpart is labeled B2, "Respiratory Infections," and then there's a part under that labeled B2-1, "Pneumonia and/or Influenza."
Q. And what studies do you have listed under this subpart?
A. This subpart includes a number of studies that have looked at the frequency of pneumonia and influenza in smokers compared to never smokers. Some of these studies have looked at death from pneumonia and influenza, some have looked simply at whether persons become ill from influenza or other respiratory infections.
Q. Let's look at a couple of these studies. Could you turn to page 23. And I want to direct your attention to the study by Kark, Lebiush and Rannon. Do you see that?
A. Yes, I do.
Q. And is that study a part of the database that you compiled as part of your investigation in this case?
A. Yes.
Q. And the trial exhibit number of that study is 16465?
A. Yes.
Q. Now directing your attention to the exhibit on the overhead, could you identify for us the number of subjects and ages?
A. Yes. This was a study of total of 336 as listed by the authors of individuals, healthy young men in the Israeli Army. They were recruits.
Q. How old were they?
A. The average age was 18.5.
Q. And could you tell us about the design of the study.
A. Yes. These investigators looked at, during an outbreak of Influenza A, the kind of influenza that we see in epidemics, how many of the military recruits who were smokers became ill and how many of the recruits who were non- smokers became ill. So everyone was exposed to influenza, and then they were able to look at the attack rate, the frequency with which the smokers became ill with influenza, and the frequency with which the non-smokers became ill with influenza.
Q. Could you take us through this table and discuss the results.
A. This --
Q. Perhaps first you can identify the title of the table.
A. The table says "Odds Ratio," which let's just interpret as relative risk, "for Influenza by Smoking Status." And then the table has a column here for the smoking, non-smokers and the current smokers, broken down here by the number of cigarettes per day, and then the relative risk for influenza.
Q. And can you tell us what the table shows in terms of relative risk for non-smokers and current smokers.
A. Yes. I think you can see that the relative risk for non-smokers, of course, is -- is one, and the values for the current smokers overall about 2.5, and then within the smokers, the relative risk rises with the number of cigarettes smoked per day.
Q. Now what does that 2.5 mean?
A. Again, that would be a 250 percent relative increase in the risk for -- for influenza.
Q. And was the study adjusted for any factors?
A. Well in a sense the study was internally adjusted because this was a very homogeneous group of young men of the same age and educational level at that point.
Q. All right. And what does the study show?
A. Again, the study shows that smokers, even at the young age of 18 or so, were more likely to develop influenza than the non-smokers.
Q. Doctor, could you turn to page 24. I want to direct your attention to the study at the top of the page, Doll, et al. Do you see that?
A. Yes, I do.
Q. And is that one of the studies in the database that you compiled in this case?
A. Yes.
Q. And is the trial exhibit number of that study 15953?
A. Yes, it is.
Q. Can you tell us about the design of this study.
A. Well again, this is a study we've already talked about. This is the 40- year follow-up information from the study of British physicians.
Q. And who was the Doll mentioned in the reference?
A. Again this is Richard Doll, who was the investigator who conducted much of the early research on tobacco smoking and health.
Q. And this study was published in 1994?
A. Correct.
Q. Can you tell us about the results of this study.
A. Okay. Again now we're looking at in this study the relative risk of dying from pneumonia comparing never smokers -- these are the data for men from the British doctors study, British doctors study -- never smokers, former smokers, and then current smokers, again by numbers of cigarettes smoked per day. And what we can see is that former smokers have approximately a 27 percent increased risk of dying from pneumonia compared to never smokers, and in the current smokers there's a dose/response rising -- rising risk, and at the highest level, 25 or more cigarettes per day, there's over a doubling of the risk of dying from pneumonia in that group of smokers.
Q. Now there's a note there that says adjusted for age, occupation, SES. What does that mean?
A. Well again, these data are age adjusted, and then there is internal adjustment, if you will, for occupation, socioeconomic status, because this study involves only physicians and only men.
Q. Well what does it mean to adjust for age?
A. It means that any differences in age between the different groups, never smokers, former smokers and current smokers, have been taken into account, so there's no confounding by age.
Q. How is it taken into account, doctor?
A. Using a mathematical technique of adjustment, standardization.
Q. Do they use stratification?
A. Well that would be the basis for the internal calculation that leads to these overall risks that we're seeing.
Q. All right. What is SES?
A. Socioeconomic status.
Q. And what does that mean?
A. That's a very general term that refers to the general level of socioeconomic status of -- I guess sort of economic well-being of people within society.
Q. Doctor, after reviewing the 98 studies and the database and the table in Trial Exhibit 30109, what conclusions have you reached?
A. I've reached the conclusion that cigarette smoking does cause diminished health status.
Q. Now has the Surgeon General made references to smoking and diminished health?
A. The Surgeon General has commented on elements of diminished health, but not on diminished health as assembled in this table.
Q. If you turn to --
This is Trial Exhibit 20179, which is table two in your expert report, that is titled "Statements from U.S. Surgeon General's Reports and the International Agency for Research on Cancer Concerning Smoking as a Cause of the Listed Diseases." Do you see that?
A. Yes, I do.
Q. And did you prepare that report -- excuse me.
Did you prepare that table?
A. Yes.
Q. All right.
MR. HAMLIN: Your Honor, we would offer table two of Trial Exhibit 20179 for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive table two from Exhibit 20179 for illustrative purposes.
BY MR. HAMLIN:
Q. If you could turn now to page 42 of table two. It's also in your demonstrative book, doctor. Do you have it?
A. Yes, I do.
Q. Okay. Now we see in the left-hand column "Disease." Do you see that?
A. Yes, I do.
Q. And what appears under that column?
A. "Diminished Health Status/Respiratory Morbidity."
Q. And then the middle column is "Statement." Now what does that refer to?
A. Statements in the Surgeon General's reports.
Q. And then the third column is titled "Surgeon General's Report," and then there are some dates. What does that refer to?
A. The years in which these statements were made in the various Surgeon General's reports.
Q. Could you go to the first entry. Now is that a statement made by the Surgeon General in 1964?
A. Yes.
Q. Can you read for us what that statement is.
A. It says, "Cough, sputum production, or the two combined are consistently more frequent among cigarette smokers than among non-smokers."
Q. Could you go to the next entry. Is that from the 1967 Surgeon General's report?
A. Correct.
Q. Could you read that entry.
A. "Even relatively young cigarette smokers show increased respiratory symptoms and decreased ventilatory function." That means lung function.
Q. There's another statement from the 1967 report listed there as well; right?
A. Yes.
Q. Could you read that statement.
A. "Cigarette smokers have higher rates of disability than non-smokers, whether measured by days lost from work among the employed population, by days spent ill in bed, or by the most general measure - days of 'restricted activity' due to illness or injury."
Q. Now could you drop down to 1972.
A. Yes.
Q. There's a statement from the 1972 Surgeon General's report there?
A. Yes.
Q. Could you read that, please.
A. "Investigations of high school students have demonstrated that abnormal pulmonary function and pulmonary symptoms are more common in smokers than non- smokers."
Q. Could you turn the page, please, doctor. That's page 43.
A. Yes.
Q. And is the disease listed there diminished health status, respiratory morbidity?
A. Yes.
Q. And the table continues with statements from the Surgeon General's reports regarding that disease; is that right?
A. That's correct.
Q. The first statement is from the 1975 Surgeon General's report; is that right?
A. Yes.
Q. Could you read that statement.
A. "In addition to an increased risk of COPD, cigarette smokers are more frequently subject to and require longer convalescence from other respiratory infections than non-smokers. Also, if they require surgery, they are more likely to develop possible operative respiratory complications."
Q. Could you go to the next statement that appears to have come from the 1979 Surgeon General's report; is that right?
A. Yes.
Q. Could you read that statement.
A. "The age-adjusted incidence of acute conditions, (e.g. influenza) for males who had ever smoked was 14 percent higher, and for females 21 percent higher than for those who had never smoked."
Q. Then could you go to the 1979 statement that references cessation of smoking. See that? It's the third entry.
A. Yes.
Q. Could you read that entry.
A. "Cessation of smoking definitely improves pulmonary function and decreases the prevalence of respiratory symptoms."
Q. Then finally on this page, can you read the last statement from the 1979 Surgeon General's report.
A. "The relationship between smoking and increased prevalence of respiratory symptoms in the adult has been well established in studies of hospital and clinic patients, working groups, total communities, and representative samples of the community."
Q. Turn to the next page, doctor. It's page 44. Once again, we see under "Disease" "Diminished Health Status, Respiratory Morbidity;" is that right?
A. Yes.
Q. And this is a continuation of the statements made by the Surgeon General with regard to that disease; right?
A. Correct.
Q. Now could you direct your attention to the 1984 statement that begins "Consideration of evidence...?"
A. Yes.
Q. And could you read that statement, please.
A. "Consideration of evidence from many different studies has led to the conclusion that cigarette smoking is the overwhelmingly most important cause of cough, sputum, chronic bronchitis, and mucus hyper- secretion."
Q. Now what is chronic bronchitis?
A. Well chronic bronchitis technically really refers to coughing up sputum from the chest on a regular basis, having cough.
Q. And what is mucus hypersecretion?
A. Well that's really what leads to chronic bronchitis, having the glands within the airways of the lungs be stimulated and in a sense overgrown by the constant irritation from smoking to produce excessive quantities of mucus.
Q. Let me direct your attention now to the first entry from the 1990 report. Do you see that?
A. Yes.
Q. Now were you involved in the 1990 report?
A. Yes. I was senior scientific editor for that report.
Q. And could you read that statement.
A. "Former smokers have better health status than current smokers as measured in a variety of ways, including days of illness, number of health complaints, and self-reported health status."
Q. And is there another statement from the 1990 report right above it?
A. Yes.
Q. And could you read that.
A. "Smoking cessation reduces rates of respiratory symptoms such as cough, sputum production, and wheezing, and respiratory infections such as bronchitis and pneumonia, compared with continued smoking."
Q. Has the Surgeon General of the United States concluded that smoking causes diminished health, as you defined it?
A. No. As I have said before, the Surgeon General has not addressed diminished health with this grouping. The Surgeon General has addressed many of the effects of smoking that are considered in the 28-page table.
Q. And can you tell us what if any significance that has with respect to whether smoking has a causal role on diminished health?
A. Well again the fact that the Surgeon General has not reached a conclusion does not mean that smoking does not cause a particular disease.
Again, this information on diminished health has not been systematically reviewed in the Surgeon General's reports, although parts of it have, leading to the statements that are in table two that we just reviewed.
Q. Now what kinds of treatments are used to treat diminished health -- diminished health?
A. Well I think we've -- we've looked at a -- a variety of problems, of consequences of diminished health. The treatments might range from perhaps an antibiotic or a medication for wheezing to in-hospital treatment for pneumonia. And as we saw in the British doctors study and other studies, there's actually an increased risk of dying from pneumonia and influenza in smokers compared with never smokers.
Q. Now based on your clinical experience, do these treatments cover a range of costs?
A. They would cover a great range of costs, yes.
Q. Doctor, did you make a review of the literature in connection with an investigation to determine whether the Surgeon General's causal criteria were met with respect to smoking and diminished health?
A. Yes, I did.
Q. Were they met?
A. Yes.
Q. Doctor, I want to direct your attention to Trial Exhibit 30155, which is on the easel. It's a summary of the Surgeon General's criteria. And could you tell us which of these criteria have been met for diminished health.
A. Let me -- let me start with consistency. I think the number of studies included in the database, the 28 pages of the table, speaks to the consistency of the -- of the evidence. This diminished health has many elements, some of which are somewhat vaguely defined like saying that you're in poor health status, so as we look at all the studies, the message from every single one is not exactly the same, but the sheer volume of the studies and the general agreement among them in terms of smoking and diminished health, absenteeism, use of health-care services, respiratory infections, respiratory symptoms, meet the criterion of consistency.
Q. What about strength?
A. Again we saw a variety of strength. As we looked at some of the other diseases, we saw very high relative risks, like 10 and 20, here we saw some that were much lower, and that's in part because these elements of diminished health that we looked at are somewhat non-specific, they're somewhat difficult to measure. As I mentioned, there are other factors that influence them. And so we see a range of strengths here, 25 percent increase in one study, for example, we looked at in terms of health-care utilization, on the other hand, a doubling or more of risk for death from pneumonia in the heavier smokers in the British doctors studies.
So I think in view of the many factors that contribute to health status, that we all know that many things affect our health status, seeing a range of strengths, some strengths would seem relatively weak compared to lung cancer, for example, where we have one predominant cause, I think the strength is in the level -- in the range where we would expect it to be given what we're talking about and the other factors that impact on health status.
Q. Could you go to the next criterion, which is specificity.
A. Again we had to put specificity aside in talking about a number of these diseases, and I'm going to set it aside here because clearly such things as using health care, missing work and so on have many factors that influence them beyond whether one is a smoker or a non-smoker. So this is a non-specific consequence of smoking, and specificity is not really applicable here.
Q. Could you address the criterion of temporality.
A. Yeah. Again I think we know that smoking comes before the occurrence of these problems. We saw evidence that when people stop for some of the conditions, the risk goes down. I don't think people who have poorer health status take up smoking, so I'm quite confident that the temporality criterion is fulfilled.
Q. And could you address the last criterion, which is coherence.
A. Yes. Coherence, remember, is where we try and place this relationship between smoking and diminished health status in perspective of -- in the perspective of everything we know, and we know that smokers are affected in many ways by their smoking, their lung reserves are diminished, the body's immune responses are changed, responses to the common respiratory viruses like influenza are changed and don't seem to be as effective as we saw in the study of the Israeli military recruits, so I think there's a variety of ways that these effects, the diminished health status, are caused by -- caused by smoking. And I think we can in these effects -- the diminished reserve, the ultimate response to infection, more severe infections in smokers -- find evidence that meets the coherence criterion.
Q. Now as senior scientific editor of the 1990 Surgeon General's report, did you address aspects of diminished health?
A. We addressed several aspects and we looked at those conclusions in table two.
Q. Okay. And in connection with your investigation in this case, did you do further research on diminished health?
A. Yes. We assembled a large group of studies that were included in the 28- page table.
Q. And was this part of your work the basis for the plaintiffs' damages model?
A. Yes, it was.
Q. Doctor, based on your education, your training, your expertise in the science of smoking and health and your review of the literature on the science of smoking and health, do you have an opinion regarding whether smoking causes diminished health status?
A. Yes, I do, and that opinion is that smoking causes diminished health status.
Q. Doctor, I want to address now the last disease, which is peptic ulcer.
What is peptic ulcer?
A. Peptic ulcer is -- refers to the erosions or ulcers that occur usually at the end of the stomach where the stomach empties out into the duodenum, and then in the first part of the duodenum, that's the very first part of the small intestine.
Q. What are the symptoms?
A. The symptoms may include pain, particularly pain when the stomach is empty. People may present with bleeding if the ulcer becomes deep enough and erodes into a blood vessel. There may actually be severe bleeding. People may have discomfort on -- on eating, weight loss, among other symptoms.
Q. And what treatments are used to treat peptic ulcer?
A. Typically, first the diagnosis needs to be made by usually at this point looking into the stomach with a tube very much like the bronchoscope, except for looking into the esophagus and stomach and duodenum. The basic treatment is medication, and for those individuals who have bleeding, surgery may be necessary to actually identify the bleeding point and sew it over so that the bleeding can be stopped.
Q. Based on your clinical experience, how much do these treatments cost?
A. Well it really would vary depending on need for medication alone up to emergency surgery.
Q. Now did you do an investigation of the published literature regarding smoking and peptic ulcer?
A. Yes.
Q. You did that in connection with your investigation in this case?
A. Yes.
Q. And did you review reports of the Surgeon General?
A. Yes.
Q. Has the Surgeon General concluded that smoking is a cause of peptic ulcer?
A. Yes.
Q. And did you do an investigation to determine whether the Surgeon General's causal criteria were met with respect to the evidence of smoking and peptic ulcer?
A. Yes.
Q. And were they met?
A. Yes.
Q. And are those studies in the database that you've compiled in this case?
A. Yes.
Q. Doctor, based on your education, training, your expertise in the science of smoking and health, and your review of the literature on the science of smoking and health, do you have an opinion regarding whether smoking is a cause of peptic ulcer?
A. Yes.
Q. What is that opinion?
A. That smoking is a cause of peptic ulcer.
Q. Doctor, could you turn now to Trial Exhibit 30154. It's a demonstrative exhibit in your demonstrative book.
What's the title of that exhibit?
A. "Diseases Caused by Smoking."
MR. HAMLIN: Your Honor, at this time we offer Trial Exhibit 30154 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30154 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, I've placed Trial Exhibit 30154 on the easel. First of all, can you repeat the title, please.
A. Yes, "Diseases Caused by Smoking."
Q. All right. And can you tell us what is depicted on this exhibit.
A. Yes. This is just a summary of the diseases that we've been discussing, with arrows pointing to the affected organs or parts of the body for all of the diseases that I concluded are caused by smoking.
Q. And can you take -- take us through those briefly. Maybe start on the left --
A. Well --
Q. -- side.
A. In the upper left, diminished health status as we've just discussed, cerebral vascular disease or stroke, oral cancer, laryngeal cancer, esophageal cancer, lung cancer, chronic obstructive pulmonary disease, coronary heart disease, aortic aneurism, peptic ulcer disease, pancreatic cancer, kidney cancer, bladder cancer, and atherosclerosis.
Q. Doctor, are you familiar with a publication called the "International Classification of Diseases, 9th Edition?"
A. Yes, I am.
Q. What is it?
A. This is the system -- the current revision of the system used to place codes on various diseases.
Q. And is it used for billing purposes as well?
A. It's used for assigning cause of death, research purposes, and billing purposes.
Q. Doctor, I want to direct your attention now to Trial Exhibit 14968. That's in the box on the chair behind you.
Could you identify that, please.
A. Yes. This is a large volume labeled "International Classes of Diseases, 9th Edition -- 9th Revision, Clinical Modification, 4th Edition."
Q. Now have you reviewed that document in connection with your work in this case?
A. Yes, I have.
Q. And does that document form a part of the basis of the opinions that you have expressed in this case?
A. Yes.
Q. And do you consider that document to be a reliable authority in the published scientific literature?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 14968.
MR. GARNICK: No objection, Your Honor.
THE COURT: Court will receive 14968.
BY MR. HAMLIN:
Q. Doctor, I want to now direct your attention to demonstrative Exhibit 30153. Do you see that?
A. Yes, I do.
Q. And can you tell me what -- what the title of that exhibit is.
A. "International Classification of Diseases, 9th Revision, parentheses, ICD-9."
MR. HAMLIN: Your Honor, at this time we would offer for illustrative purposes Trial Exhibit 30153.
MR. GARNICK: No objection.
THE COURT: Court will receive 30153.
BY MR. HAMLIN:
Q. Doctor, can you tell me what is set out on Trial Exhibit 30153?
A. Yes. This trial exhibit gives the diseases that we've just talked about as caused by smoking and then beside them are numbers. These refer to the ICD codes, International Classification of Diseases codes for each of these diseases with the exception of cerebral vascular disease and coronary heart disease, where there are several extra codes.
Q. You see at the top, doctor, in parentheses ICD-9. Do you see that?
A. Yes, I do.
Q. What does that refer to?
A. That's simply the abbreviation of International Classification of Diseases, 9th Revision.
Q. And are these codes sometimes referred to as ICD-9 codes?
A. Very often, yes.
Q. Is that how you refer to them?
A. Yes.
Q. Now have you had an opportunity to review claims information and billing records of Medicaid recipients and Blue Cross Blue Shield of Minnesota subscribers in this case?
A. I've reviewed some records.
MR. GARNICK: Your Honor, I think this goes beyond the scope of the expert report.
MR. HAMLIN: I don't believe so, Your Honor. I believe it's very clear from his expert report that he has looked at diseases that are caused by smoking, and this is well within the scope of that, and that's precisely what we are going to be talking about.
MR. GARNICK: There's no mention of billing records and looking at billing records at all.
MR. HAMLIN: Your Honor, I -- well, if I could.
THE COURT: Yes.
MR. HAMLIN: I think that as a foundation for the plaintiffs' damages model, Dr. Samet assisted in terms of looking at billing records, and that was disclosed both by Dr. Samet and by the plaintiffs' damages experts in their expert reports. I mean this is nothing new.
THE COURT: You may answer the question.
A. I'm sorry, can you repeat the question?
Q. Yes.
Have you had an opportunity to review claims information and billing records of Medicaid recipients and Blue Cross Blue Shield of Minnesota subscribers in this case?
A. Yes, I have.
Q. And do they contain ICD-9 codes?
A. Yes, they do.
Q. Have you used ICD-9 codes in your research?
A. Yes, I have.
Q. And are you familiar with their use in coding clinical encounters for billing purposes?
A. Yes, I am.
Q. Let's go back to Trial Exhibit 30153. Doctor, are there direct consequences of the diseases listed on that exhibit that can also result in health-care costs?
A. Yes. For example, for cerebrovascular disease or stroke, code 342, which is right there, is simply the number given to one of the consequences of stroke I talked about, weakness of part of the body or hemiplegia or hemiparesis, so the codes beside it, 430 to 438, refer to stroke itself, 342 refers to this complication of stroke.
Q. Do you have a name for those kinds of consequences?
A. Well we often use the word sequelae -- not such a good word -- but complication, in talking about some of these effects.
Q. And do the ICD-9 codes for these complications appear on Trial Exhibit 30153?
A. Well some do. As I mentioned for stroke, code 342 is the code for hemiplegia. For coronary heart disease, other codes listed beyond 410 to 414, which are the primary codes, include codes for heart failure or failure of the heart muscle to be able to keep up with the needs of the body after a heart attack, and also disturbances of the heart rhythm that might follow a heart attack.
Q. Doctor, are there other direct consequences of smoking-caused diseases that are not listed on Trial Exhibit 30153?
A. Yes. Codes, for example, are not listed for the metastasis that might arise from the cancer. For example, there is no code here for involvement of the brain or the bones by cancer or perhaps damage to the spinal cord and paralysis that might come from metastasis to or around the spinal cord, and many of the other complications, pneumonia for example, that might come with lung cancer. So there's been -- we have not attempted -- I have not attempted in putting together these codes to think of every possible sequelae of the smoking-caused diseases.
Q. And again, "sequelae" means --
A. The sort of complications or effects that come because of the disease being present.
Q. Now are prescription drugs assigned ICD-9 codes?
A. No, they're not.
Q. So are any prescription drugs listed on Trial Exhibit 30153?
A. No.
Q. Have you listed all of the codes corresponding to diminished health on Trial Exhibit 30153?
A. No. The codes that are listed are those for the specific respiratory infections, but not the other outcomes.
Q. Now doctor, this is -- strike that.
Is this an exhibit that you yourself put together?
A. Yes.
Q. Why aren't all of the codes corresponding to diminished health listed?
A. Again, I think it would be very difficult to assemble a full list of the codes corresponding to the many ways in which diminished health status could lead to health-care encounters.
Q. And why is that?
A. I think in part because of the somewhat non-specific nature of this diminished health status condition and the specific details of the coding system.
Q. Doctor, as part of your investigation in this case, have you also reviewed literature regarding the role of socioeconomic status in smoking and disease?
A. Yes, I have.
Q. And are there approximately 100 articles in the database that you've compiled that deal with that subject?
A. In the database there are about 100 articles where socioeconomic status has been considered as to whether it affects the causal -- as to whether it affects the relationship between smoking and disease, yes.
Q. Now what is socioeconomic status?
A. Again, this is sort of a technical term, jargon, used to refer to the sort of relative economic well- being of persons in our society.
Q. Now what role, if any, does socioeconomic status play in the relationship between smoking and disease?
A. I think study after study, including the 100 or so in the database, show that smoking has risks for people at the higher end and the lower end of the socioeconomic scale alike, and certainly the effects of smoking are not due to any failure to control for socioeconomic status in examining the effects of smoking.
Q. Now did you have any involvement with respect to plaintiffs' damages model?
A. Yes, I did.
Q. Who did you work with?
A. I worked with Drs. Scott Zeger, Timothy Wyant and Leonard Miller.
Q. And can you tell us about Dr. Zeger.
A. Dr. Zeger is one of my colleagues at Johns Hopkins. He's chair of the Department of Biostatistics; that is, using statistical mathematical techniques to analyze health data essentially.
Q. Can you tell us about Dr. Wyant.
A. Yes. Dr. Wyant is a statistician, actually a graduate of the Johns Hopkins School of Public Health Department of Biostatistics, who works as a consultant.
Q. You say a graduate. What is his degree?
A. I believe that Dr. Wyant holds a Ph.D. degree.
Q. And can you tell us about Dr. Miller.
A. Dr. Miller is an economist, I guess a health economist, at the University of California-Berkeley, and I think that he holds a Ph.D. degree from that school.
Q. Now did you offer advice to Drs. Miller, Wyant and Zeger regarding smoking and the diseases caused by smoking?
A. Yes, I did.
Q. And did you supply them with the ICD-9 code numbers of the diseases caused by smoking?
A. Yes, I did.
Q. And those are listed on Trial Exhibit 30153?
A. Yes.
Q. And that's something that you compiled; correct?
A. That's correct.
Q. Did you have assistance from Dr. Zeger, Wyant and Miller in compiling that list?
A. No.
Q. Did you advise them as to whether all health-care costs were captured by the ICD-9 codes listed on Trial Exhibit 30153?
A. Yes.
Q. What did you tell them?
A. I told them as we've discussed, that all the sequelae of the smoking- causes -- -caused diseases would not be captured in the ICD codes, ICD-9 codes, and similarly I advised them that the consequences of the diminished health status would not be captured in the ICD-9 codes included on the board alone.
Q. Now did you provide advice to them regarding ways to screen the Blue Cross and Minnesota Medicaid data?
A. Yes, I did.
Q. First of all, for what purpose?
A. I advised them in how to screen these data; that is, the claims data, to be certain that we were identifying persons as having the disease who were -- who really had it; that is, to try to avoid false positive identification as persons having a smoking-caused disease.
Q. And what did you recommend in terms of the screening?
MR. GARNICK: Objection, Your Honor. This whole subject matter is not mentioned in the expert report.
MR. HAMLIN: Your Honor, we have disclosed this in both the depositions as well as in the damages expert report, and they have been well advised as to this subject matter.
THE COURT: You may answer. You may answer.
A. I provided guidance on several points in terms of screening the data. First with regard to age, I indicated that there should be age screens put into place in the data.
Q. Now what -- what did you recommend?
A. By that I recommended that ICD-9 codes corresponding to certain causes of disease should not be considered as caused by smoking unless the person with that ICD-9 code had reached a certain age, either 40 in the case of lung cancer or 35 -- 40 in the case of chronic obstructive pulmonary disease or 35 in the case of the other diseases included on the listing; that is, the specific diseases, not diminished health status.
Q. Why did you make that recommendation?
A. Because these diseases are relatively uncommon. I already talked about temporality and how we don't see these diseases until people have generally smoked for a substantial period of years. I recommended the age screen so as to avoid false positives. With large numbers of claims records, sometimes errors in coding occur, and this screen was intended to identify any such occurrence.
Q. What other screens did you recommend, doctor?
A. I also recommended a screen with regard to diagnostic tests. Sometimes people have a diagnostic test that might be coded, let's say, to lung cancer or one of the -- one or another of these diseases to try and rule out the presence of the disease, so perhaps a smoker comes and is coughing up blood during a respiratory infection and the physician, to make sure that that blood is not coming from a cancer, orders a chest x-ray. Well that x-ray might be given the code on the board 162 that corresponds to lung cancer, but perhaps the chest x- ray is completely normal, this is just what happens with a bad chest cold, coughing up some blood, and there's not a real diagnosis of lung cancer. So to avoid false positives from these diagnostic tests, ICD-9 codes assigned to diagnostic tests were not considered in establishing the presence of a smoking- caused disease.
Q. And did you recommend any other screening device for the claims information of Medicaid data and Blue Cross Blue Shield Minnesota claims data?
A. Yes, I did. The final screen, again to avoid false -- false positives, was to suggest that a diagnosis of a smoking-caused disease not be counted unless there were at least two health-care encounters -- visits, hospitalizations -- for that disease within a two-year time span. So that someone who just had one visit, they were not counted, because it seems unlikely that they could have one of these conditions that we talked about, one of these diseases that is so serious, and only end up seeing -- having one health-care encounter for that disease. So the screen I recommended was that there be at least two health-care encounters within a span of two years.
Q. Now for purposes of clarification, doctor, what do you mean by "false positive?"
A. By that I mean identifying someone as having one of these diseases when the truth really is that they -- that they don't. And that could have arisen just because of problems in the billing claims record or perhaps because of this diagnostic test issue; a physician is trying to make sure that someone doesn't have a problem, and it turns out that they really don't.
Q. And that was the purpose of the screens.
A. That's correct.
Q. Doctor, did you also offer advice about the conceptual structure of the plaintiffs' model?
A. Yes, I did.
Q. And could -- could you tell us what that conceptual structure is and then break it down on the flip chart?
MR. HAMLIN: Your Honor, if we may have permission to have Dr. Samet approach the flip chart.
Q. Dr. Samet, you stated that you offered advice to Drs. Miller, Wyant and Zeger regarding the conceptual structure of plaintiffs' damages model. Could you write on the flip chart what the conceptual structure of that damages model is.
A. Well essentially I suggested that since we know that smoking causes disease and smoking-caused disease result in health-care utilization and health-care costs, that the model should address smoking-caused disease, and that within smoking-caused diseases I suggested two broad classes of disease, those where a very high proportion of the cases are caused by smoking, which, as we've heard, is lung cancer and COPD, and then I suggested that the other diseases caused by smoking could be grouped, so other diseases.
Q. And did you identify yet another subpart of the conceptual model?
A. I further identified that health-care costs would arise from diminished health status, poor health status, and suggested that another path to health- care costs was poor health status.
Q. And did you offer any further advice with respect to the conceptual model?
A. Right. Again, the final advice regarded nursing home, simply identifying that smoking causes diseases which may require nursing-home care.
MR. HAMLIN: Your Honor, we've marked Dr. Samet's chart as 25022, that's the trial exhibit number, and we offer that for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 25022.
MR. HAMLIN: Thank you, Your Honor.
THE COURT: Why don't we take a short recess at this time.
MR. HAMLIN: Certainly, Judge.
THE CLERK: Court stands in recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
BY MR. HAMLIN:
Q. Doctor, other than your advice on diseases and screenings, did you offer any advice as to what the plaintiffs' damages model should measure?
A. No, I did not.
Q. Did you provide any advice to Drs. Zeger, Wyant and Miller regarding statistical methods to be used in the model?
A. No, I did not.
Q. Did you provide to Drs. Zeger, Wyant and Miller any advice regarding modeling methods?
A. No.
Q. Doctor, do you claim any expertise in the kind of health-care cost modeling performed by Drs. Zeger, Wyant and Miller in this case?
A. No, I do not.
Q. As part of your investigation in this case, have you reviewed scientific literature about the health risks of lower tar and lower nicotine cigarettes?
A. Yes.
Q. Have you written research papers on the health risks of lower tar and lower nicotine cigarettes?
A. Yes, I have.
Q. Doctor, what is tar?
A. Tar is a technical term that refers to the findings of a specific assay of cigarette smoke done according to a method of the Federal Trade Commission. Tar actually refers to the weight of material deposited on a filter when a cigarette is smoked in a smoking machine according to a specified protocol. The smoke is passed through a filter called a Cambridge filter, and tar refers to the weight deposited on that filter when the cigarette is smoked according --
in the machine according to a protocol, the weight deposited on that filter less the weight of any water in the smoke and also the weight of nicotine.
Q. What is the origin of those protocols; that is, what federal agency prepared those protocols?
A. The protocol is specified by the Federal Trade Commission, the FTC.
Q. Doctor, could you turn to Trial Exhibit 4994. I believe that's in your box. That's monograph seven. Can you identify that, doctor?
A. Yes, I can. This copy -- the volume is entitled "Monograph 7" in a series called "Smoking Tobacco Control," the name is "The FTC Cigarette Test Method for Determining Tar, Nicotine and Carbon Monoxide Yields of U.S. Cigarettes: Report of the NCI Expert Committee."
Q. Doctor, did you review this document as part of your investigation in this case?
A. Yes, I did.
Q. And does it form part of the basis of your opinions in this case?
A. Yes.
Q. And do you consider it to be a reliable authority in the published scientific literature?
A. Yes, I do.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 4994.
MR. GARNICK: No objection.
THE COURT: Court will receive 4994.
BY MR. HAMLIN:
Q. Now doctor, does --
Well first of all, this exhibit that we just introduced is also known as monograph seven; is that right?
A. Correct. Monograph seven is a series of monographs from the National Cancer Institute.
Q. What is a monograph?
A. Just a book.
Q. And did you make any contributions to monograph seven?
A. Yes. I contributed a chapter to that monograph on health risks of changing cigarettes.
Q. Does monograph seven contain the protocols for measuring tar?
A. Yes, monograph seven provides a description of the protocol for measuring tar.
Q. Can you give us a brief description of those protocols.
A. Just -- I already mentioned the protocol in part, but in brief, cigarettes are sampled according to a specified sampling scheme and brought to the test laboratory, they're smoked in a machine that smokes 20 cigarettes at a time according to a predetermined pattern of smoking, essentially a puff every minute, the puff lasts two seconds, and the volume of the puff is 35 milliliters, which I guess would be a little over two teaspoons equivalent, and the cigarette is then smoked down to a specified length.
Q. And is there a filter involved in this test?
A. Correct. The smoke is passed through this Cambridge filter, just a filter pad that collects the materials that are in the smoke that are solid or gases that might be absorbed, I guess, onto the filter.
Q. How is tar then measured?
A. Tar is the weight on the filter, the gain in weight of the filter after the cigarette is smoked, and taken away from that weight is the weight of water and the weight of nicotine.
Q. And what if anything does the FTC then do with that weighting?
A. Well this testing is the basis of the tar rating for that particular cigarette.
Q. How did these protocols come about?
A. They have their origins in part in a paper published by a Dr. Ogg, O-g- g, who made observations on smoking patterns and how people puffed and how much he thought they puffed, and his work, and I guess however he drew on the work of others, became the basis for the FTC protocol, which I think has been in place since 1967.
Q. Doctor, I want you to turn to Trial Exhibit 30146, which is in your demonstrative notebook.
A. Yes.
Q. Do you have that?
A. Yes, I do.
Q. And what is the title of that exhibit?
A. "The Changing Cigarette."
Q. And is the source of the information in this demonstrative the Federal Trade Commission?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30146 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30146 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, I've placed Trial Exhibit 301 -- 416 -- excuse me, 416, on the easel, and can you tell us what we see?
A. On the easel we just see the percentage of cigarettes in the United States, sold in the United States with filter tips --
Q. I'm sorry, I misidentified the exhibit, it's 30146.
A. Just continuing, this shows the percentage of U.S. cigarettes with filter tips starting in 19 -- early 1955 or so and moving on to -- up to 1993. And you can see the rapid rise across the '50s, '60s, of the use of filter cigarettes, so that today, except for a few percentage of the cigarettes, almost all of the cigarettes smoked are filter-tipped cigarettes.
Q. Doctor, do we have some overlays?
A. Yes, there are two overlays, one showing the tar delivery and the other the nicotine.
MR. HAMLIN: Your Honor, may Dr. Samet come down and approach the exhibit to work with the overlays?
A. Okay. So we're looking, as I said before, just at -- on this exhibit, at the percentage of U.S. cigarettes with filter tips, and now I'm just going to turn over the -- over the first overlay. Here we're now going to look at the nicotine yield of the cigarettes, and what we're looking at is a sales-weighted average, so here we have the percent of filter tips, the blue, and now over here we have the sales-weighted average, milligrams of nicotine, and you can see a decline starting out here with some of the earliest data where that average was up about three, moving down towards about one milligram at 1990.
Q. Do you have another overlay?
A. Yes, I do.
And then on the last overlay we're going to look at the same kind of information as we saw for nicotine, except now it's for tar. Remember, this is the tar measured according to that FTC protocol on a machine. So here we can see tar values. And now the scale is changed, we're going from zero to 40 milligrams -- remember, nicotine was from about zero to four milligrams going to an average of one -- for tar, you can see back here at the earliest point it was about 35 milligrams in the average, and now as the line is moved down over time, it's at about ten, 12 -- a little bit above 10, perhaps 12 milligrams of tar as the average of the cigarettes sold.
Q. Doctor, what do you mean by "The Changing Cigarette," which is the title of this exhibit?
A. Well this exhibit just brings together information on filter tips, nicotine and tar, and describes how over time, essentially over 40 years, filter-tip smoking has risen, and in terms of the tar yields and nicotine yields, these have declined.
Q. Thank you, doctor.
Doctor, I believe you stated that you have written papers on the subject of lower tar and lower nicotine cigarettes; is that right?
A. Yes, I have.
Q. And have you specifically addressed the health risks in connection with the use of those cigarettes?
A. Yes, I have.
Q. Let me direct your attention to Trial Exhibit 15914, which is in your testimony book, doctor, and could you identify that study.
A. Yes. This is a paper based on the case-control study of lung cancer that we did in New Mexico that I mentioned yesterday. This is called -- the paper is called "Determinants of Lung Cancer Risk in Cigarette Smokers in New Mexico."
Q. When was it published?
A. It was published in 1986.
Q. Where?
A. In the Journal of the National Cancer Institute.
Q. Is that a peer-reviewed journal?
A. Yes, it is.
Q. Now does that article -- well strike that.
Have you reviewed that article as part of your investigation in this case?
A. Yes, I have.
Q. Does that article form part of the basis of your opinions in this case?
A. Yes.
Q. Do you consider that article to be a reliable authority in the published scientific literature?
A. Yes, I do.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 15914.
MR. GARNICK: No objection.
THE COURT: Court will receive 15914.
BY MR. HAMLIN:
Q. Doctor, can you tell us about the design of this study.
A. Yes. This was a case-control study, so the cases were persons from throughout the state of New Mexico. In fact, we attempted to identify every one in the state who had developed lung cancer during the period of the study, which was 1980 to '82. We also identified a random sample of the state's population that was matched to the cases on age, sex, in this case Hispanic or non-Hispanic ethnicity, and then we did a detailed interview concerning smoking and a number of other factors.
The interview on smoking asked about filter-tip use, and we were able to essentially calculate how much of the time that each person who smoked had smoked non-filter and filter cigarettes.
Q. What were your findings, doctor?
A. Well we found in the non-Hispanics in the study that there was an approximate 20 percent reduction in lung cancer risk comparing those who had smoked non-filter-only cigarettes to those who smoked filter cigarettes. We did not find that the risk changed in the dose/response way with the number of year the proportion that filter-tip smoking had taken place; that is, for those who smoke more and more filter-tip cigarettes, we did not see a decline in risk. But overall there was about a 20 percent drop in risk in the non-Hispanics. And the Hispanics, the numbers were much smaller, but we actually found a greater decline in risk than we found in the non-Hispanics with the extent of filter- tip cigarette smoking.
Q. And were the number of Hispanics large or small in that study?
A. The total number of Hispanics of the 501 -- the 521 cases --
I'll need to find the exact -- the exact numbers here. Approximately 150 to 160 Hispanic cases.
Q. Let me direct your attention now to Trial Exhibit 26004. That's also in your testimony notebook. Could you identify that study, doctor.
A. Yes. This is a paper published in a journal called the American Review of Respiratory Diseases in 1993, it's entitled "Cigarette Yields of Tar and Nicotine and Markers of Exposure to Tobacco Smoke," it's authored by David Coultas, Christine Stidley and myself.
Q. And have you reviewed that article as part of your investigation in this case?
A. Yes, I have.
Q. Does it form part of the basis of your opinions in this case?
A. Yes.
Q. And do you consider it to be a reliable authority in the published scientific literature?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 26004 as a learned treatise.
MR. GARNICK: No objection, Your Honor.
THE COURT: Court will receive 26004.
BY MR. HAMLIN:
Q. When was this paper published, doctor?
A. 1993.
Q. Can you tell us about the design of this study that is described in the paper.
A. I mentioned this study yesterday. This was -- this study is based on data collected from a small community in New Mexico where we had done a door- to-door survey measuring lung function, asking about respiratory symptoms, measuring blood pressure, and looking at other health measures. We made two measures of markers of exposure to tobacco smoke. First we collected a saliva specimen, actually from several thousand people, and we analyzed those saliva specimens for the level of cotinine. That's a metabolite. It's one of the by- products of nicotine after the body acts to break down the nicotine. And we can measure that in small samples of saliva.
Q. What did those measurements tell you?
A. They give us an index of an actual level of the tobacco smoke component or by-product cotinine within people who smoke or those who are passively exposed to tobacco smoke.
We also measured -- the other marker that we measured was carbon monoxide, and we did that by collecting a breath sample. We all exhale some carbon monoxide, and by carefully collecting a breath sample from people, we can then take that breath sample, pass it through a carbon monoxide analyzer, and then measure the level of carbon monoxide. And again, this gives us another measure of how much of the tobacco smoke component carbon monoxide has been taken up into people.
Q. What did you find, doctor?
A. Well in this study we tried to understand whether there was any relationship between these measures, the cotinine levels and the carbon monoxide levels, and the values of the Federal Trade Commission for nicotine and tar. So we did an analysis where we tried to understand if we could explain the level of cotinine that we found in these smokers. There were 293 smokers included in the study, current smokers. We did an analysis -- I'm sorry, 298 -- to determine if the level of cotinine was explained by the level of tar or of nicotine, and what we found in the study was that after taking account of the numbers of cigarettes smoked per day, there was only a very weak correlation. We learned very little more about the level of cotinine from information on the tar values and nicotine values of the cigarettes actually being smoked by the smokers.
Q. And so what conclusions did you draw, if any?
A. Well --
Q. And specifically I want to refer you to page 440 of your study.
A. Okay. If I can just perhaps read the last paragraph of the study, it says, "Although many smokers perceive cigarettes labeled low in tar and in nicotine as less hazardous, our results suggest that FTC cigarette yields provide the smoker with inaccurate information on actual exposures to tobacco combustion products. Smokers need to be advised about the limitations" --
MR. GARNICK: Your Honor, Your Honor --
A. -- "of cigarette yield "--
MR. GARNICK: Your Honor.
THE COURT: Just a moment.
MR. GARNICK: I need to lodge an objection. The exact testimony that he's giving now goes way beyond the expert report, talking about the awareness and the expectations of consumers. That certainly was not in the expert report. It's not in any of the depositions taken or any of the depositions taken that refer to Samet.
MR. HAMLIN: Your Honor, this goes to health risks, that's the subject matter of this paper, and that is the subject matter -- or one of the subject matters in Dr. Samet's expert report. There's no question about that.
MR. GARNICK: We have no objection to health risks, but this talks about what consumers know or what they don't know, and that's a different issue.
THE COURT: Well I'm going to allow you to continue.
Q. Yeah. You were interrupted, doctor. Could you start again?
A. "Although many smokers perceive cigarettes labeled low in tar and in nicotine as less hazardous, our results suggest that FTC cigarette yields provide the smoker with inaccurate information on actual exposures to tobacco combustion products. Smokers need to be advised about the limitations of cigarette yield information. Switching to lower yield cigarettes may not reduce a smoker's exposure to hazardous tobacco combustion products, and switching is unlikely to produce substantial health benefits -- benefits compared with those that follow complete cessation."
Q. Doctor, I now want to direct your attention to Trial Exhibit 26005 in your demonstrative notebook. Do you see that?
A. Yes, I do.
Q. Is that an excerpt from the 1981 Surgeon General's report?
A. Yes.
Q. And what was the subject matter of the 1981 Surgeon General's report?
A. "The Changing Cigarette."
MR. HAMLIN: And for the record, Your Honor, that 1981 report has been admitted as Trial Exhibit TG000237.
Could we put the first page of the exhibit -- well let -- let me ask -- first of all --
Yeah, that's fine. We can put it up. All right.
Q. Doctor, do you see the section there marked "Cancer?"
A. Yes.
Q. Do you see paragraph one?
A. Yes.
Q. Could you read paragraph one.
A. Yes. "Today's filter-tipped, lower 'tar' and nicotine cigarettes produce lower rates of lung cancer than do their higher 'tar' and nicotine predecessors. Nonetheless, smokers of lower 'tar' and nicotine cigarettes have much higher lung cancer incidence and mortality than to non-smokers."
Q. Then if you could turn the page, doctor, to page 19, to the section marked "Cardiovascular Disease," could you read that first paragraph, please.
A. "Epidemiological studies show that the incidence of coronary heart disease (CHD) increases as the daily number of cigarettes smoked increases and that the incidence of CHD decreases among those who quit smoking. These dose- related effects suggest that lower 'tar' and nicotine cigarettes might be associated with lower risks of CHD. However, the overall changes in the composition of cigarettes that have occurred during the last 10 to 15 years have not produced a clearly demonstrated effect on cardiovascular disease, and some studies suggest that a decreased risk of CHD may not have occurred."
Q. Doctor, could you turn the page to page 20, to the section marked "Chronic Obstructive Lung Disease."
A. Yes.
Q. See paragraph one?
A. Yes.
Q. Could you read that.
A. Yes. "The relationship between cigarette smoking and chronic obstructive lung disease (COLD) is well documented. The constituents of cigarette smoke that are responsible are currently not known. Whether a difference in risk of COLD has occurred with lower 'tar' and nicotine cigarettes as compared with higher 'tar' and nicotine cigarettes is currently unknown."
Q. Now this reference is to chronic obstructive lung disease. Does that have any relationship to chronic obstructive pulmonary disease that we've been talking about?
A. Yeah. As I mentioned, the terminology here is varied, and COLD was the name in use at that particular time, 1981, for what we now call COPD.
Q. Now let's go to the article that you referenced earlier, your article on "The Changing Cigarette." That is at Trial Exhibit 26003. Do you have that?
A. Yes, I do.
Q. Can you identify that article.
A. Yes. This is an article entitled "The Changing Cigarette and Disease Risk: Current Status of the Evidence," by myself, and published in Smoking and Tobacco Control monograph number seven, the one on the FTC method.
Q. And when was the article published?
A. 1996.
Q. And have you reviewed this article as part of your investigation in this case?
A. Yes, I have.
Q. And does this article form part of the basis of your opinions in this case?
A. Yes.
Q. Do you consider this article to be a reliable authority in the published scientific literature?
A. Yes, I do.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 26003.
MR. GARNICK: No objection.
THE COURT: Court will receive 26003.
BY MR. HAMLIN:
Q. Now doctor, can you tell us for what purpose this article was prepared?
A. Yeah. The article was prepared for a meeting of the president's cancer panel that had been convened to examine the issue of the FTC protocol and essentially the relevance of the existing protocol to health issues.
Q. And when was that meeting?
A. That was in December of 1994.
Q. Can you tell us the subject matter of the article.
A. Yes. In this article I reviewed the evidence, emphasizing the evidence since 1981, on how changes in the cigarette may have affected health risks of smoking.
Q. And when you say you reviewed the evidence since 1981, are you talking about the evidence with respect to health risks of lower tar and lower nicotine cigarettes?
A. That's correct. I focused on the epidemiological studies that provided some information on this issue.
Q. And why did you choose 1981 as your starting point?
A. Well that was the time when the Surgeon General's report had addressed this topic.
Q. Okay. And are your findings and conclusions on page 86 of that article?
A. Yes.
Q. And could you tell us what your findings and conclusions are with respect to lung cancer.
A. Yes. I actually sort of left my conclusions to sit against those made in 1981 in the Surgeon General's report. I had just read you the conclusion about the Surgeon General -- of the Surgeon General's report in 1981 with regard to lung cancer risk, showing some reduction in lung cancer risk for smokers of lower tar compared to smokers of higher tar, and I said that the more recent evidence remained consistent with that conclusion, the 1981 conclusion.
Q. Did you also reach a conclusion with respect to chronic obstructive pulmonary disease?
A. Yes, I did. And at -- at that time the conclusion had read that it was unknown whether risk was lower for COPD for smokers of low tar or lower tar and nicotine cigarettes compared with those smoking higher tar and nicotine cigarettes, and my review of the evidence found no reason to, again, not accept that conclusion.
Q. Did you reach a conclusion with respect to coronary heart disease?
A. Yes. Again my conclusion followed that of the Surgeon General's report of 1981, that we had no evidence, no consistent evidence that the tar yield and particularly the lower tar/nicotine cigarettes were associated with a reduction of risk of coronary heart disease.
Q. Now doctor, could you turn to Trial Exhibit 30167. That's in your demonstrative notebook.
A. Yes.
Q. Do you have that?
A. Yes, I do.
Q. And could you identify that document for the record.
A. Yes. This is a --
Q. Just tell me what it is.
A. I'm sorry?
Q. Just tell me what it is.
A. It is a graph of data from a study published in 1976.
Q. And let me direct your attention to Trial Exhibit 16076 in your testimony notebook and ask you whether or not that is the study that forms the basis of the graph.
A. Yes, it is.
Q. Can you identify that study.
A. Yes. This is a paper published in the journal entitled Environmental -- called Environmental Research, the title of the paper is "Tar and Nicotine Content of Cigarette Smoke in Relation to Death Rates," and the authors are E. Cuyler Hammond, Lawrence Garfinkel, Herbert Seidman and Edward Lew.
Q. Did you review this study as part of your investigation in this case?
A. Yes, I did.
Q. And does this study form part of the basis of your opinions in this case?
A. Yes, it does.
Q. And do you consider this study to be a reliable authority in the scientific literature?
A. Yes.
MR. HAMLIN: Your Honor, we would offer Trial Exhibit 16076.
MR. GARNICK: No objection.
THE COURT: Court will receive 16076.
MR. HAMLIN: We would also offer Trial Exhibit 30167 for illustrative purpose on the basis that the data is taken from Trial Exhibit 16076.
MR. GARNICK: No objection.
THE COURT: All right. Court will receive 30167 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, I've placed on the easel Trial Exhibit 30167. Can you first of all tell us what the title of that exhibit is?
A. Title is "Relative Risk of Death from Lung Cancer by Tar/nicotine Content of Cigarettes, CPS-I, Current Smokers Versus Never Smokers."
Q. What is CPS-I?
A. That's the Cancer Prevention Study number one of the American Cancer Society, the cohort study, the prospective study of one million Americans that began in 1959.
Q. And approximately when did it end?
A. 1972.
Q. All right. So this data covers the period 1959 to 1972.
A. Correct.
Q. And can you tell us, first of all, about the axes of the data -- excuse me, of the graph.
A. Okay. We're looking at a scale of relative -- relative risk, comparing, again, never smokers at one, and then we have relative risk values for lung cancer for three different groups of current smokers. They've been defined by the level of tar and nicotine of the cigarette they usually smoke.
Q. Now let's take the first bar. That is labeled "High." Now from your understanding of the data, what does that mean?
A. In terms of my understanding of what the authors did, the smokers put into the high bar were smoking cigarettes that had nicotine content of two milligrams or more, and tar of 25.8 or more. Actually the tar was said to extend from 25.8 to 35.7 milligrams, and the nicotine from two to 2.5 milligrams of nicotine.
Q. Could you go to the bar marked "Low."
A. Yes. This bar.
Q. Yes. And what is your understanding of what the low nicotine and low tar represented by this bar graph is?
A. The smokers --
Q. Low.
A. Right. The smokers placed into this category, low, were smoking cigarettes that had nicotine yield less than 1.2 milligrams, and for the most part tar yield of less than 17.6 milligrams. So 1.2, less than 1.2, and generally less than 17.6.
Q. What is the medium?
A. Medium was essentially all the other smokers, so they would lie with a nicotine -- nicotine value between 1.2 and two, and tar values somewhere between about 17.6 and 25.8. So that's the mid group.
Q. Now the Y axis is labeled "Relative Risk." Right?
A. That's correct. It shows the relative risk for lung cancer in these three groups compared to the never smokers who, as we've seen before, are down here, set equal to one.
Q. It goes up to 10; is that right?
A. That's correct.
Q. Now what does that mean?
A. Well ten would correspond to a tenfold increase in risk, comparing the smoker to the never smoker for one cancer, or 1,000 percent.
Q. What is the relative risk for high tar/high nicotine content cigarettes smoked?
A. Well I think --
Q. Based on this chart.
A. Right. Based on this chart, I think you can see that it was almost nine, I think a little bit -- it's over eight and perhaps not quite making nine.
Q. And what is the relative risk for low tar/low nicotine cigarettes?
A. Well I think you can see that it's above six and about 6.5, approximately, about a 650 percent relative increase.
Q. What is the relative risk for never smokers?
A. It's one.
Q. Now what significance can you draw from this graph, doctor?
A. Well I think there's two conclusions that can be reached. One, comparing the high and the low group, we see about a 20 percent reduction in lung cancer relative risk, moving from the high value, greater than 25.8 milligrams of tar, greater than two milligrams of nicotine, to the low value, which again here was less than 1.2 milligrams of nicotine and generally less than 17.6 milligrams of tar.
The other general conclusion is that all of these values are much greater than one. So even though we see about a 20 percent reduction going from the high tar/nicotine group to the low tar/nicotine group, the low tar group is still left with a relative risk for lung cancer about 650 percent that of the never smokers at this time from '59 to '72.
Q. Now how much was the tar reduced from high to low, what percentage?
A. Remember, we're looking at the category here that's about 25.8 up to 35, so somewhere around an average of, let's say, 30, and down here we're looking at values under 17, so there's roughly an approximate twofold difference in tar intake comparing low to high.
Q. And what is the difference in relative risks from high to low?
A. It is about 20 percent.
Q. Let me direct your attention now to Trial Exhibit 30168. Can you identify that document for the record?
A. Yes. Again this -- this exhibit shows data taken from the study by Hammond and colleagues.
Q. And that's the exhibit that we previously identified as Trial Exhibit 16076?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30168 for illustrative purposes only.
MR. GARNICK: No objection.
THE COURT: Court will receive 30168 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, I've placed Trial Exhibit 30168 on the easel. Could you read the title of that, please.
A. "Relative Risk of Death from Coronary Heart Disease by Tar/nicotine Content of Cigarettes, CPS-I, Current Smokers Versus Never Smokers."
Now CP -- what does CPS-I refer to?
A. Again, this is the American Cancer Society's Cancer Prevention Study number one.
Q. And what were the years that --
A. '59 to '72 for these data.
Q. All right. So this is, as you said, based on the same data that the earlier chart was; right?
A. Yes.
Q. The one on lung cancer?
A. Yes.
Q. Doctor, what conclusions can we draw from this chart?
A. Well again on this chart, as on the previous chart, we're looking at the relative risks now for death from coronary heart disease, going from the high group, with the same definition as on the previous chart, the medium group, same definition, and the low, and again here, never smoker relative risk 1.0. Again we, I think, can reach the same general conclusions. In this study there was a small reduction in relative risk for death from coronary heart disease, going from the highest tar group to the lowest tar group, but again, in each of the three tar/nicotine groups, the relative risk values were substantially above the value of 1.0 for never smokers; more, the 1.5 line would mark 50 percent increase, and you can see they're all above that.
Q. And what does that mean, doctor, to you?
A. Well that means that in this study there was a small reduction in the relative risk of coronary-heart-disease death moving from the highest intake of tar/nicotine to the lowest, but that these relative risk values were still substantially above what they could have been absent smoking, which is 1.0.
Q. Let me now direct you to Trial Exhibit 30169. Could you identify that, doctor.
A. Yes. Again, this exhibit shows data taken from the same study, this time on the relative risk of death.
Q. And again, this is CPS-I data?
A. That's correct.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30169 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30169 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, I'm placing on the easel Trial Exhibit 30169. Could you read the title of that.
A. "Relative Risk of Death by Tar/Nicotine Content of Cigarettes, CPS-I, Current Smokers Versus Never Smokers."
Q. And again, the CPS-I data was based on data from 1959 to 1972?
A. Yes.
Q. And can you tell us, doctor, the significance of what we see on this graph.
A. Now what we're looking at is the relative risk of death, that's from any cause. Before we were looking at coronary heart disease, and before that lung cancer. Now we're talking about just the risk of dying.
Again, the data are laid out the same, high, medium, and low tar/nicotine intakes, and relative risk for never smokers here at 1.0. What you can see, again, as we saw for the lung cancer and for coronary-heart-disease death risks, some small reduction going from the high tar to the low -- high tar/nicotine group to the low tar/nicotine group, going from here down to here. But again, you can see that even in the low tar/nicotine group, the relative risk is 1.5, so that means that compared to the never smokers, the smokers in that group have a 50 percent increased risk of dying during the times '59 to ' 72 from all of the varied causes of death.
Q. And doctor, do you have a demonstrative that compares the early data of CPS-I to later data from CPS-II with respect to relative risks?
A. Yes, I do.
Q. Is that Trial Exhibit 30163?
A. Yes.
MR. HAMLIN: And that has been previously admitted, Your Honor.
Q. I'm going to place that on the easel. If you would, doctor, with the court's permission, could you come down and explain the changes in relative risk between the earlier data from CPS-I and the later data from CPS-II. But perhaps we could begin by explaining what this demonstrative exhibit describes.
A. Okay. We -- we looked at this yesterday. Remember, the American Cancer Society did two studies, each of one million Americans. The first group began their participation in the study in 1959, the second group, CPS-II, 1982.
This side of the board shows the findings for a number of the major smoking-caused diseases for men, and for women. These are now relative risk values, current smokers compared to never smokers. Age has been taken into -- into account. We're looking at study number one, study number two; men, women, study number one, study number two. So here we can look and see how the relative risks have changed over time.
In fact the comparison here for CPS-I is 1959 to '65, and for CPS-II, 1982 to '86, so we're looking across about a 24-, 25-year span, and now we're looking at how the risks of smoking have changed for current smokers, remembering that over time, as shown down here, there have been some changes in the smoking of filter-tip cigarettes and also in the FTC values of tar and nicotine for those cigarettes.
Q. You were referring to Trial Exhibit 30146, "The Changing Cigarette?"
A. Yes, I am.
So now we can go back and just compare CPS-I to, for example, lung cancer. CPS-I, the relative risk for current smokers is 11.9, in CPS-II it's 23.2. Other cancers caused by smoking, all grouped together, 2.7 to 3.5. coronary heart disease, 1.7, the first study, 1.9, the second. Chronic obstructive pulmonary disease, 9.3, 11.7. And stroke, 1.3 to 1.9.
And then on the other side, moving over to the other side of here, we see the data for women with a relative risk going from CPS-I, '59 to '65, 2.7, with CPS-II, '82 to '86, 12.8. Other cancers, 1.8, 2.6. Coronary heart disease, 1.4, 1.8. COPD, 6.7, 12.8. And finally stroke, 1.2 to 1.8.
So in each of these comparisons we see an increase comparing the relative risk for current smokers for dying from these smoking-caused diseases comparing CPS-II, '82 to '86, to CPS-I, earlier, '59 to '65.
Q. And what was happening to the tar and nicotine contents during that time period; that is, the '82-plus time period?
A. Well if I can refer to this --
Q. Yes, you can refer to Trial Exhibit 30146.
A. What we can see, then, if we think about individuals who were studied in the period '59 to '65, certainly their currently-smoked products would have been at the higher end of these lines, and of course their smoking histories would have extended back here off the chart. The individuals studied in '82-'86 for those who were currently smoking would have been actually smoking cigarettes about where values are now, because these lines would tend to flatten out, and their smoking history would extend across the time that these FTC values of tar and nicotine were declining.
Q. Now doctor, let me ask you this: Based on Cancer Prevention Study I and II, were the health risks of smoking lower tar and lower nicotine cigarettes declining in the later years when the tar content was declining?
A. Well I think comparing the two studies we can see that these relative risk values are going up comparing number one, '59 to '65 -- well number two, ' 82 to '86, to number one, '59 to '65.
Q. Doctor, let me direct your attention now to Trial Exhibit 30170. That's in your demonstrative book. Do you have that?
A. Yes, I do.
Q. Okay. Can you identify that, doctor.
A. This is a table showing data from CPS-I and CPS-II.
Q. And now let me refer you to Trial Exhibit 18927, which is in your box on the chair behind you. Can you identify this document, doctor.
A. Yes. This is a copy of a monograph entitled monograph eight in the Smoking and Tobacco Control series, "Changes in Cigarette-Related Disease Risks and Their Implication for Prevention and Control."
Q. And is this -- is this document the source of the data for the demonstrative exhibit, Trial Exhibit 30170?
A. That's correct.
Q. Let me refer you now to the monograph eight, which is Trial Exhibit 18927. Have you reviewed that document in connection with your investigation in this case?
A. Yes, I have.
Q. And does it form part of the basis of your opinions in this case?
A. Yes.
Q. Do you consider it to be a reliable authority in the scientific -- published scientific literature?
A. Yes, I do.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 18927.
MR. GARNICK: No objection.
THE COURT: Court will receive 18927.
BY MR. HAMLIN:
Q. Now as I understand it, doctor, you were one of the editors of monograph eight; is that right?
A. That's right, along with colleagues.
Q. All right. Let's go back now to the demonstrative exhibit. We've established that the demonstrative is based on monograph eight; correct?
A. Correct.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30170 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30170 for illustrative purposes.
BY MR. HAMLIN:
Q. Doctor, could you identify Trial Exhibit 30170.
A. Yes. This is a table called "Comparison of Lung Cancer Mortality Rates and Relative Risks Over Time, American Cancer Society."
Q. And with the court's permission, doctor, could you come down so that you could testify about this chart.
Now is this chart based again on CPS-I and CPS-II data?
A. Yes. This is a more detailed breakdown of just some of the data from CPS-I and CPS-II.
Q. Can you tell us what we see on this chart?
A. Yes. This chart shows some of the very detailed data now trying to look within specific levels of age; for example, men ages 55 to 59 and smoking, to get a better picture comparing within strata of age and smoking how risks have changed of smoking between the two studies. So we're looking at, again, lung cancer mortality rates.
So the first box up here provides data for men ages 55 to 59, '59 to '66 in CPS-I, '82 to '88 in CPS-II. And if I can go on to explain the --
Q. Sure.
A. There -- there's several different measures here. There's the relative risk that you've seen before, one column labeled "Relative Risk." There's also one labeled "Rate Per 100,000," and that number just refers to the rate of death per hundred thousand persons in the never smokers, men smoking 20 cigarettes a day for 40 to 44 years, or 40 cigarettes a day for 40 to 44 years. So all the rates of disease have just been adjusted to a denominator of 100,000 persons in the line labeled "Rate."
And then the relative risk values are like you saw before, so the never smokers are one, and this 9.6 is actually just 135, which is the rate in the smokers in this particular category divided by 14.1, the rate in the never smokers.
Q. So if I can point to the relative risk column, are the relative risks in that column for CPS-I?
A. Those are for CPS-I.
Q. And what time period is that?
A. In this particular chart, '59 to '66.
Q. And could you compare that to the relative risks for CPS-II.
A. Yes. We can make that comparison simply looking -- of course in both studies the relative risks for never smokers is one. You can see that for men smoking 20 cigarettes a day for a period of 40 to 44 years -- remember these men are aged 55 to 59 -- the relative risk was 9.6 in CPS-I, and in CPS-II it's 94.2.
Q. Now when was CPS-II?
A. '82 to '88.
Q. Okay. So that was later.
A. That was later, correct.
Q. And what is the relative risk comparison for men smoking 40 cigarettes a day?
A. Okay. Again 40 cigarettes a day, that's two packs a day, for 40 to 44 years, the relative risk was 23.7 CPS-I, 136, 137 in CPS-II. So there's been an increase in both of these categories comparing CPS-I and CPS-II.
Q. And during the entire time period 1959 to 1988, what was happening to the tar content of the cigarette?
A. If I can refer to this exhibit.
Q. That's Trial Exhibit 30146.
A. I think we can see that, again, as we saw before, comparing the period ' 59 to '66 to '82 -- '82 to '88, here we're on the flat portion of this curve, and those people smoking would have had some years of exposure to declining tar and nicotine levels. The smokers earlier, '59 to '66, would have been exposed to generally higher values of the earlier -- earlier time period.
Q. Doctor, during the years that the tar value was declining, what was happening to the health risks?
A. Well here I think if we look both at the relative risks and then also we can just simply look at the rates, we can see that the rates went up, 135 to 235, 334 approximately to 342, that's the rate per 100,000, and just on the top of the table, and the relative risks went up.
Q. Now doctor, do we also have a demonstrative exhibit for women from CPS-I and CPS-II?
A. Yes.
Q. And that's Trial Exhibit 30171?
A. Yes.
MR. HAMLIN: Your Honor, we offer Trial Exhibit 30171 for illustrative purposes.
MR. GARNICK: No objection.
THE COURT: Court will receive 30171.
BY MR. HAMLIN:
Q. Doctor, can you identify Trial Exhibit 30171.
A. Yes. This is a very similar exhibit labeled "Comparison of Lung Cancer Mortality Rates and Relative Risks Over Time, American Cancer Society." It's laid out the same way as the last exhibit, but now it's for women.
Q. Okay. Can you point out the relative risk for women ages 55 to 59 in CPS-I.
A. Okay. In CPS-I, those values are on this side of the exhibit.
Q. Okay. And what are those values?
A. Okay. Just, for example, looking at women ages 55 to 59, we again have the rate per hundred thousand and the relative risk, and then for women 55 to 59, the rate of relative risk for those smoking 20 cigarettes a day for 30 to 34 years and those smoking 40, or two packs a day, for 30 to 34 years.
Q. And what are the relative risks, then, for CPS-I for those two groups?
A. Okay. I think here we can see one for the never smokers. For those smoking a pack a day, or 20 cigarettes for 30 to 34 years, the relative risk of six, and for those smoking 40 a day, or two packs a day, for 30 to 34 years, the relative risk is 29.4.
Q. Now if you will, doctor, please direct your attention to CPS-II. Now CPS-II again was later data from 1982 to 1988; right?
A. That's correct.
Q. That was a different cohort?
A. Different cohort.
Q. All right. But can you tell us what happened to the relative risks?
A. Okay. Comparing CPS-I to CPS-II, and again these are within women of the same age and smoking with the same smoking histories, in terms of cigarettes per day and number of years smoked, we can see that the relative risk values have gone up over time as have the actual rates of lung cancer in -- in these women.
Q. And specifically what is the increase for the women ages 55 to 59?
A. So women aged 55 to 59 smoking 20 cigarettes, or a pack of day, for 30 to 34 years, the relative risk per study CPS-I is six, and it's approximately doubled in the second study to a relative risk of 12.
Q. What about the relative risk for women smoking 40 cigarettes per day --
A. Okay.
Q. -- for 30 to 34 years?
A. Again for women, it's this line, the relative risk has been from 29.4 to 32.7 in the second study.
Q. All right. And then we talked about the group of women ages 60 to 64. Can you compare the relative risks in CPS-I and CPS-II for those -- that group?
A. Yes. Again here's the same sort of information, more limited in this heavier-smoking group for CPS-I, that's why there are dashes here, but looking just at the line 20 cigarettes, or a pack a day, for 30 to 34 years, women 60 to 64, the relative risk in CPS-I was 2.2 and in CPS-II was 19.3.
Q. So the relative risks were going up.
A. The relative risks are going up comparing the two studies, correct.
Q. And they went up in the later years.
A. Correct.
Q. And during those later years, what was happening to the tar content, according to Trial Exhibit 30146?
A. Again referring to this graph, we saw the decline in the FTC values, this is the sales-weighted average tar content and nicotine content.
Q. Doctor, do you have an animation that shows the health risks of lung cancer from the period 1950 to 1996?
A. Yes.
Again, we're just going to take a look at the findings of the epidemiological study included in the database as those results have been published over the years shown on the bottom of the graphs. So these are the findings of the studies for men, beginning in 1950 and extending into the 1990s.
Q. Now what is -- what is the source of the data for this graph?
A. The source of the data are the studies included in these boxes in front and abstracted into the computer database.
Q. So it's more than CPS-I and CPS-II; right?
A. That's correct.
Q. And what if any pattern do we see here, doctor?
A. Well I think if there's any pattern, it's perhaps that these relative risk values have tended to go up over time. There's certainly no evidence that they have gone down over time.
Q. And during this period 1950 to approximately 1996, what was happening to the tar content of cigarettes?
A. Well I think the -- as -- as we've seen, the FTC values of tar were declining.
Q. And do you have a graph for women?
A. An animation?
Q. An an --
Excuse me, an animation.
A. Yes.
Again, this is the same sort of animation for women, we've seen this before, the results of the epidemiological studies on lung cancer in women across the last 40 years.
Q. Again, what patterns do we see here, doctor?
A. Again, I think here, if anything, there's a pattern of rising relative risks of lung cancer in women comparing smokers to non-smokers.
Q. What is the source of the data for this -- for the graph that appears on the overhead?
A. The source is the epidemiological studies reviewed and abstracted into the computer database.
Q. So this was more than CPS-I and CPS-II.
A. That's correct.
Q. Now do you have an animation for coronary heart disease for men?
A. Yes, I do.
Again, the same sort of display of information, showing the results of the epidemiological studies from the '50s forward over time.
Q. And again, what patterns do we see here?
A. Well I think, if anything, there's perhaps a tendency for these relative risk values to be mounting, and certainly no clear tendency for a decline.
Q. Do you have an animation for women and CHD?
A. Yes.
Q. That is coronary heart disease.
A. Again, the same sort of animation for women. This is now for coronary heart disease from approximately 1970 forward.
Q. And what patterns do we see here?
A. Certainly not a clear pattern of declining relative risks over time, and perhaps some evidence of an increase.
Q. And what is the source of the data for this graph that appears on the overhead?
A. The epidemiological studies abstracted and placed into the computer database.
Q. Do you have an animation for COPD for men?
A. Yes. Again the same sort of animation, now looking at men 1950 through 1996 for chronic obstructive pulmonary disease.
Q. What if any pattern do we see here?
A. Well the earlier values are perhaps among the lower, and these values toward the end tend to be higher.
Q. What is the source of this data?
A. Again, the epidemiological studies that have been reviewed and abstracted into the computer database.
Q. And do you have an animation for the relative risk of COPD for women?
A. Yes.
Q. Can we see that.
A. Again, now, this animation is beginning in about 1970.
Q. And what if any pattern do we see here?
A. Well we have relatively few studies, and I think it's perhaps hard to make out any pattern given that we only have eight -- eight bars here.
Q. Now doctor, let me ask you this: Are the results which we have just seen in the CPS-I and CPS-II data as well as in the animations with the relative risks -- with respect to the relative risks, are they consistent with your conclusion in your "Changing Cigarette" paper that you authored regarding the health risks of lower tar and lower nicotine cigarettes?
A. Yes, they are.
Q. Why?
A. Well again, in that review I concluded that there was little evidence for reduction of the risk of smoking the lower tar and nicotine products. I indicated that there was some reduction for lung cancer but little evidence of a reduction for either coronary heart disease or chronic obstructive pulmonary disease to the very important conditions caused by cigarette smoking. So when we look at how the evidence has come out over time from the different epidemiological studies, it's quite consistent with my conclusion that we certainly see no evidence of declining relative risks for these smoking-caused diseases, and perhaps, if anything, for some of them, evidence of rising relative risks.
Q. And this is all during the time period when the tar content is going down, --
A. That's right.
Q. -- according to the Trial Exhibit that we've referenced earlier.
A. Yes.
THE COURT: I think we should recess.
MR. HAMLIN: Fine, Your Honor.
THE COURT: And we'll reconvene tomorrow morning at 9:30.
THE CLERK: Court stands in recess, to reconvene tomorrow morning at 9:30.
(Recess taken.)
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