Deposition 3 - deposition of doctor in products liability case - Part 5

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BY MR. GLOOR:

Q Is there any study that has less than overwhelming acceptance that says there's a relationship, a peer-reviewed study?

A No, there's just a large number of case reports that are scattered over a, you know, fairly long period of time that -- that suggests that there's a relationship.

Q There are articles and studies that suggest there's no relationship at all. Aren't there also those studies out there, Doctor?

A Well, this is, again, I mean, the problem is that you're looking at Park -- you're assuming Parkinson's disease is one disease, but we're saying is that, I mean, A, is -- that this isn't exactly -- that many of these people, this is a definable disorder.

In our own clinic, for instance, if we go back and look at welding history in our clinic, we've got all kinds of people that never came closer to a welding rod than -- than, you know, than that billboard who have got Parkinson's, and where do they get it from? Well, the bottom line is that, I mean, about two percent of our patients have a welding history.

Now, if you -- to dissolve two percent of a group into a 98 percent group and then look for any correlation, you'll never find that two percent. They're hidden in there. Because statistics relies on homogeneity of the sample. This is a heterogeneous sample. I mean, you know, you're stuck with that. And I think that's the problem.

That's where Calne's article, I think, is important, because it finally says, you know, whoever said Parkinson's disease was one disease? It's merely a large dumping can that we throw a lot of similar conditions into.

The fact that there's no good study, it's based on the false premise that you're looking at one disease, and I think that the way to get around that is to go down to a source. I mean, we're doing this the right way. Look at a group of people who have a lot of exposure. How often do you find the disease? Peer-reviewed papers will be forthcoming; they're just not available yet.

Q So just make sure we're together -- and we're almost done, Doctor, by the way, that's the good news -- is as of this moment in time, there is no peer-reviewed paper that shows there's a relationship between welding and Parkinson's disease, correct?

A Agreed.

Q All right. Anymore -- I'm looking to my colleagues for anymore questions. Hold on. Hold on.

MR. McCOY: I have a couple -- couple follow-ups. You want me just to ask him here?

MR. GLOOR: Let me see what I've got.

Q Maybe two other questions. In the database you have for not just the welding patients you talked about before, but the entire patient community, are occupations put down on those who are here for treatment?

A Yeah, yeah, everybody's got an occupation or past occupation listed. Now, it's -- it's apparent that our data from 15 years ago isn't as good as it should be.

Q But at least that -- there is --

A It's in there.

Q Something is in there.

A (Witness nods head.)

Q And have you examined your global, total universe of patients, to examine what occupations there were?

A At the moment, that data -- our database isn't -- isn't complete. I mean, so I can't tell you what our 20,000-patient database is going to show because you can't look at it till you're done with it.

Q Is this -- Is the 20,000 number, that's the patient here in Wisconsin, correct?

A That's this clinic's patient -- That's a rough -- That's a number of how many patients have actually been followed in this clinic since 1985.

Q Okay. One more question, I think I'm going to be done. As of this moment, is it generally accepted in the field of neurology that Parkinson's disease is one disease only?

A I don't know that if I can speak for --

Q And not -- and not more than one disease.

A I don't think I can speak for like general neurology. I think as a specialist in Parkinson's disease, I mean, it seems to me that we're looking at a large number of diseases that have some similar characteristics, but are probably different diseases.

To the general neurologist, I think it's a question of can you treat it or not treat it, and so they diagnose it as Parkinson's or not Parkinson's.

MR. GLOOR: I'll just look over my notes, but I think we could be done.

(There was discussion off the record.)

MR. GLOOR: Done. Thank you, Doctor.

EXAMINATION

BY MR. McCOY:

Q Let me just do a couple follow-up questions, Doctor. Let's take your own patients within this clinic for a moment. And you mentioned something about a two percent figure for welders or persons exposed to welding fumes. Do you remember -- do you recall that --

A Yeah.

Q I mean, tell me if I'm misstating here.

A Correct. I mean, that -- that number is a rough estimate based on the fact that we have a hundred and -- actually, as of today, 136 people in our clinic who have been carried as Parkinson's disease who offer a significant history of industrial exposure to welding materials, and what we've been doing in that group is sequentially bringing them in and taking them off their meds to see how much therapeutic benefit they actually are getting from their meds.

And, in fact, when they're off their meds, you frequently see a tremor reappear. And the tremor has the same frequency characteristics we talked about. It's not a Parkinson's tremor at all. And it seems to us that we're looking at a cohort group that has some response to meds, but, in fact, has manganism, not Parkinson's disease.

If one extrapolates that 135 to the active patient population, it comes out to something like 1.7, 1.8 percent of the active patients would appear to have a potential diagnosis of manganese poisoning rather than Parkinson's disease.

That's based on this clinic, which, again, what's our selection bias? Hell, I don't know. I mean, this is a highly industrial area, there's lots of welding that goes on here, there's lots of manganese used in the Milwaukee area in a variety of industrial operations, but that's still a significant number. And I think that that -- I think other clinics are going to need to look at their own data in the same way to try to make heads or tails out of the observations that are coming out of things like our experience on the Gulf Coast.

Q Is the methodology that you're employing when you make those conclusions based upon your own patient database, is that one that's generally accepted within your profession?

A I think it's generally accepted within my profession. It's probably not generally accepted by biostatisticians, who would want this done in a much more rigorous way. I mean, you know, this is a clinical practice; it's not a research laboratory. It just happens to be a very big practice.

So that to analyze, you know, how often does a given patient come back to the clinic, most patients come back every four months or three -- or three months. Some patients only come back once a year. Some patients only come back once every two years. I don't know what that number reflects in terms of the active patient group.

I know -- I know how many patients we see a year, but I don't know how -- It's hard to take that number and say with great certainty exactly what the active patient population is. There's a mathematical way of doing it, but we don't have -- we've not analyzed it that way.

I can tell you how many welders I've got, I can tell you how many patients we see, but predicting the ac -- or producing the actual prevalence requires more information about the activity level of the patients that are in the office.

Q But, again, if terms of your own profession, putting biostatistics aside for a moment, is the methodologies that you've described something that's relied upon within your profession?

A Yeah, I think it's the standard, you know, that that's what cause and effect relationships are based on. You have to look for a risk factor and see whether that risk factor has any predictive effect on the presence of a disease.

Q Okay. So now let's -- let's turn for a moment to the -- there's a publication coming out in Neurotoxicology?

A That's what they tell me.

Q Okay. And you mentioned something about a mean age in that -- Is that published in the -- or is that something that's going to be ultimately published or something that you've arrived at?

A That's -- that's in the data, the mean.

Q Okay. And what -- what is that mean age?

A It's 49. I can't remember what the standard deviation of the mean is, but the mean age of onset of the patients was, you know, was below 50.

Q And what is the group with -- who has that mean age of 49, how would you define that group?

A Those were patients who we thought had the disorder more consistent with manganism than with Parkinson's disease.

Q Drawing from what original --

A The same criteria we offered before, laterality, type of tremor, response to meds.

MR. GLOOR: Is that the Gulf Coast group we're talking about?

THE WITNESS: Yeah.

MR. GLOOR: You referred to them as patients. Is that an incorrect statement?

THE WITNESS: Well, somebody with Parkinson's disease. I guess I don't have a lot of friends who have Parkinson's who haven't discussed their medical case with me.

MR. GLOOR: I'm talking about the Gulf Coast group. They weren't patients, were they? They --

THE WITNESS: No, most of them -- most of them -- Actually, yeah, they've never been seen by physicians.

MR. GLOOR: But were they your patients is what I'm asking.

THE WITNESS: I'm -- I'm the first person that ever gave them that diagnosis. I suppose that established some kind of a relationship.

MR. GLOOR: But in terms of doctor-patient, --

THE WITNESS: No.

MR. GLOOR: -- someone being licensed to do it, you weren't rendering treatment, were you?

THE WITNESS: Oh, no.

MR. GLOOR: You weren't prescribing medications to the Gulf Coast group.

THE WITNESS: No. I didn't want to get into that much trouble.

BY MR. McCOY:

Q Now, let me -- Let's just talk more about the Gulf Coast -- stay with the Gulf Coast group for a moment and the sub -- Let's just stay with the Gulf -- Gulf Coast group that's going to be the subject of that publication when it comes out.

And is the methodology employed in that -- arriving at the conclusions you've arrived at concerning that Gulf Coast group, is that also one that would be generally accepted within your profession?

A Yeah, I mean, I think it would be generally accepted. It's the one we chose because it was the only one that seemed to me to be tenable, and we submitted it to a journal. I mean, Neurotoxicology, I assume they know something about the issue of epidemiologic study of toxic agents. They thought it was an acceptable publication, not because they liked the methodology, because they liked -- they thought the results were significant.

MR. GLOOR: Did they say they didn't like the methodology?

THE WITNESS: Well, it's the same thing we called for in our discussion session. This calls for -- you know, it was like Racette's last paragraph, every sector -- this calls for a more detailed, in-depth study looking at, you know, all the risk factors.

The absolute values are -- I mean, I think they call for some further action in -- in a very timely way because they're just way too high to be explained as -- as chance incidents of Parkinson's disease. It can't possibly be the explanation.

MR. McCOY: And, again, my question is based upon what he would use within his profession, not based upon the methodology of a biostatistician or epidemiologist. I mean --

Q So this -- One of the -- Oh, here it is. We talked about the patient in your practice who worked at the Eveready Battery plant?

A Yes.

Q Okay. And that was one of the autopsy patients where you saw the report, right?

A I saw the report. You didn't -- We didn't bring it in here, but yeah, I've got it.

Q You saw it. Okay. And what was the diagnosis in that patient before the -- before death? Did you have one?

A Yeah. I -- I called it manganism, my partner called it Parkinson's, Mayo Clinic called it multi-systems atrophy, and I think the University of Wisconsin-Madison, I think that was the other consulting group they saw, I think they called it MSA.

MR. GLOOR: What did the autopsy report call it?

THE WITNESS: Manganese poisoning.

MR. McCOY: Okay. I think that covers my follow-up questions.

EXAMINATION

BY MR. GLOOR:

Q Just a couple, and I'll be real quick. Did you ever see the article by Dr. Fryczek, F-r-c-z-y-k or something like that?

A I'm not good at names.

MR. KOPRIVA: F-r-y-c-z-e-k.

THE WITNESS: What was the article about?

BY MR. GLOOR:

Q Danish welders.

A Okay.

Q Ring any bells? It's a recent one.

A I think I've seen that one. I think I've seen that one. I don't recall -- That's the one that didn't show any correlation -- didn't have a higher prevalence in that -- in that work group.

Q It was like the Kim conclusion.

A Yeah.

Q Which comes up Parkinson's disease, yes.

A But wasn't it a neuropsych study, not a neurological exam? One of our -- As I recall. It was -- it was more like the Roels Bowler stuff.

Q I don't remember that, but have you seen that, though; do you recall seeing that article?

A If it's come out, I'm sure I've seen it, or whether -- how well it's registered --

Q It's been accepted for publication; I don't believe it's been published.

A If it hasn't been published, then I don't -- I mean, there's studies like that that have come out of a variety of European sites saying that they can't see the same correlation.

Q Do you discount those studies that --

A Well, the techniques --

Q -- reach that conclusion?

A Well, the techniques are different. I mean, the problem -- You know, everybody uses a slightly different criteria for the cut-off, and I think that's the problem in Korea, was that what we wanted to do was we'd like to get them over here, or we'd like to go over there again and actually be in the field with the people who do the exams or have them here and do the exams with us. Because I think there's a -- their threshold's a lot different than others in terms of identifying abnormalities.

Q When you were with Kim in Korea -- Is it Dr. Kim? I don't mean to --

A Dr. Kim, yeah.

Q -- Dr. Kim in Korea, did you talk about the kind of exposures that the welders were having in the shipyards? Any data on that given to you?

A Oh, yeah. I mean, he's got tremendous data on, you know, how many parts per million there are in the air. That's -- that's very exhaustively done there.

Q Did you see that data when you were there?

A No, I didn't see it when I was there. I've seen it before, though. It's -- it's in earlier publications of his that -- that aren't related to this. There's a pulmonary section of papers.

Q Besides Kim, Dr. Kim, did you see any other doctors, Ph.D.'s, industrial hygienists, anyone else as part of the work you're doing for Ranier or Barrett or Bob or anyone else?

A Well, the reason we were talking to Kim had nothing to do with Ranier or anybody else, except they were -- they were the ones who arranged the meeting.

We met with a number of other Ph.D.'s and -- and representatives of the Korean, you know, government, but we talked about medical issues and issues related to things other than -- other than --

Q Who else did you meet that you can recall over in Korea besides Dr. Kim?

A I met with Dr. Yung, who is a chemist. He's an MIT graduate who's a professor at Korea University whose big thing is bioterrorism. And then we met with two other individuals, one who's a -- was a forensic specialist and a public health specialist who trained Dr. Kim, and the other one was the minister -- the son of the founder of Korea University, who, in fact, was the minister of -- it wasn't health and welfare, it was something like that, who actually -- his sister's at the University of Chicago in sociology, so we ended -- we talked about all kinds of other stuff besides -- besides Madison.

Q You talked about welding issues with these other people besides Dr. Kim?

A Well, we talked about -- Yeah, I've talked about welding issues and about the role of tort litigation in the United States and how it might differ in -- in Korea.

Q What did he say?

A That, in fact, it was very similar in Korea. That's one of the reasons they have such stringent precautions with their workers, is that the -- is that it's not -- it's possible, apparently, to sue for work-related injuries or harm generated in the course of work in Korea, and they're trying to keep that under control because their costs, their labor costs, are very high, and that's putting them out of the market; it's making them not competitive.

Q Besides Dr. Kim and those in Korea, did you talk to any doctors, authors --

A No.

Q -- about the issues involved in this litigation?

A We didn't talk about the litigation much. They were -- they were a little bit gun shy --

Q I'm actually focusing on those not in Korea. Anyone else in this country or in New Zealand or Australia, or for that matter anywhere else, that you talked to besides Dr. Kim and those in Korea?

A Oh, I see. You mean in terms of global communication?

Q Anyone else, sure.

A No, not -- not at the moment.

Q Any plans to see anyone else?

A There's a whole bunch of people I'd kind of like to see, I mean, who I'd like to get some information from, but, I mean, we have no clear-cut plans, nor any direct, you know --

Q Who would you like to see?

A I'm not going to tell you that.

MR. McCOY: Let me object to the speculative nature of these questions.

THE WITNESS: Again, it's sort of--

MR. McCOY: It's not -- it's not something he's relying upon in this case. It's somebody who he'd like to see.

THE WITNESS: It's a wish list. I shouldn't tell you that; you might get to him first.

BY MR. GLOOR:

Q Are you going to tell me who they are?

A No, I'm not going to tell you that. I'm not good at names anyway, you already know that.

MR. GLOOR: I'm done. Thank you very much, Doctor.

THE WITNESS: Sure.

MR. GLOOR: You have something more? Hold on. Wait.

THE WITNESS: Okay. One more.

MR. GLOOR: Okay.

(There was discussion off the record.)

BY MR. GLOOR:

Q The difference in the type of tremor between PD, Parkinson's disease, and manganism is what?

A Well, I mean, Parkinson's disease is a -- is traditionally a resting tremor. It's a tremor when the patient's motor activity is not being directed at the limb that has the movement. And there's a whole bunch of other Rubrics about Parkinson's tremor. If it involves the head, it's generally a up-and-down tremor, not a to-and-fro tremor.

Q In manganism, what is it?

A Manganism -- In mang -- Well, in many people with manganese exposure who have parkinsonian symptoms, they have a tremor which is predominantly antigravity. When they hold their hand out, when they hold their hands up in front of them, you'll see the persistence of a tremor which doesn't have a very significant finger-to-nose component.

Q Is that called an intention tremor or something?

A Well, finger-to-nose tremor is -- Intention tremor is traditionally cerebellar. These aren't cerebellar. These are -- So it's not a cerebellar tremor, it's not a Parkinson's tremor, it's an action tremor. And there's lots of textbook illustrations of action tremors and how they affect handwriting, which many physicians rely on, and the handwriting looks different.

Welders tend to have a tremor that looks more like benign essential tremor than like Parkinson's tremor, although they usually have both. There's a frequent coexistence of resting tremor and this -- this -- this action tremor.

The problem -- The differences are, of course, that this tremor frequently responds to antiparkinson's meds, and its frequency characteristics are unlike Parkinson's or benign essential tremor.

MR. GLOOR: Thanks.

THE WITNESS: You're welcome.

THE VIDEOGRAPHER: Any further questions? Hearing no further questions, that concludes the video deposition of Paul Nausieda. You're off the record at 5:01 p.m.

(Concluded at 5:01 p.m.)

(Exhibits were attached.)

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