Opinion ID: 836272
Heading Depth: 1
Heading Rank: 1

Heading: facts

Text: In 1978, plaintiff received silicone gel breast implants following a bilateral mastectomy. [1] Both implants partially deflated: the first in 1980 (which was replaced), the second in 1992. In 1993, plaintiff had the implants surgically removed, at which time it was discovered that one implant had ruptured. Plaintiff filed this action in 1994, alleging that silicone from the implants had migrated throughout her body and caused personal injuries. Defendants maintained that plaintiff's symptoms were caused by fibromyalgia and were not the result of the breast implants. [2] At trial, plaintiff called Dr. Grimm to testify about medical causation. Grimm is a board-certified neurologist with an advanced degree in neurophysiology. [3] Defendants did not question Grimm's qualifications to determine the causes of neurological deficits in patients in general, but did challenge Grimm's opinion testimony regarding causation in this case. In response to defendants' admissibility challenge, the trial court conducted an in limine hearing as directed by State v. O'Key, 321 Or. 285, 307 n. 29, 899 P.2d 663 (1995). [4] At the hearing, Grimm testified that he became interested in the neurological consequences of silicone in 1993, when he examined two very sick women. As a result, he began to examine women who had silicone breast implants. At the time of plaintiff's trial, he had examined about 50 women, 45 of them in 1994. Grimm testified that, among the women he had examined, he found a unique pattern that I had never seen in any other neurologic disease in this sample of women. Basically two features. One was that they were all relying on vision for their balance, because there was something wrong with their inner ear in the absence of the usual things of trauma, concussions, tumors, infections, genetic histories, et cetera. And the second thing was that while all of them hadI can't say all, but we'll say 95 percenthad patterns and complaints of tingling in their fingers and so forth, most of them were unaware that there was a loss of sensation, actual physical loss of sensation to touch, in their fingers and toes. Grimm found that 43 of the 45 women he had examined in 1994 had vestibular difficulties: [5]  I had never seen in my career widespread neurologic disorders, or read about as a neurologist thiswhat I thought was a unique pattern. When 45 women come in, they're sent to me from different places, and they have different implant stories, different health histories, different physical troubles, past histories, and so forth. And the unique thing was that there was an extraordinarily high correlation, 95 percent had the combination of unusual sensory patterns and the inner ear. (Emphasis added.) Grimm further testified that the pattern he had observed in the women was distinguishable from a cross section of the population at large. He indicated that the combination of the two conditions is extremely rare, even among people with neurological disorders. Grimm acknowledged that his findings had not been published in any medical literature or subjected to peer review. Grimm examined the women in his study as follows: First, he performed a classic neurologic examination. That is, he mapped the areas where the patient had lost sensation using pins and brushes, with [the patients'] eyes closed, going back and forth and making marks on their skin, in exactly what areas of hands or a foot    where the reception was down. And I would do this in various ways to test the veracity of the patients. Second, he sent the patients to the vestibular laboratory at Good Samaritan Hospital in Portland. That laboratory measured each woman's inner ear function. With some of the women, Grimm had additional tests performed. In an attempt to determine the cause of the women's symptoms, Grimm then performed a differential diagnosis. [6] In a differential diagnosis, a doctor develops a list of all diseases that might cause a patient's symptoms and then, by a process of elimination, narrows the list. Mary Sue Henifin, Howard M. Kipen, and Susan R. Poulter, Reference Guide on Medical Testimony, 463, in Federal Judicial Center, Reference Manual on Scientific Evidence (2d ed. 2000) (hereinafter Reference Guide on Medical Testimony). Grimm also examined the women's histories and possible exposures for other causes of the same symptoms. Silicone was the only common exposure he found among the women. Grimm also considered the research of others on animals. Respecting Grimm's ultimate conclusions about medical causation, plaintiff's counsel asked:    [H]ave you limited your involvement and workup and conclusions that you would express today to your field of expertisethat is, to say, neurologyand drawing conclusions about the relationship between silicone exposure and the neurological ramifications of these women's health? A. Yes. Plaintiff's counsel then introduced the subject that lies at the heart of this case, viz., Grimm's opinion as to the cause of plaintiff's condition: Q. And have you formed an opinion to a reasonable medical probability based on established and accepted medical and scientific methodologies that silicone has caused a condition in these women? A. Yes. I think there's unquestionably a very strong correlation. What I don't understand is the mechanism yet. That, I'm working on. I cannot say that I have got to that point in my work, that I understand the mechanism. It's unquestionable about the association in these patients with their unusual neurological picture. Q. Are you in a position, then, based on your work and the application of scientific methodology, to express opinions based to a reasonable scientific probability, one, that a silicone-related neurological condition exists? A. Yes. Q. And, two, based on your evaluation of [plaintiff], she has the signs and symptoms of such a condition? A. Oh, yes. Easily. (Emphasis added.) It appears that plaintiff's counsel intended the foregoing exchange to beand that the trial judge and defendants accepted it asa statement that, in Grimm's opinion, plaintiff's condition was caused by the ruptured silicone gel breast implants. The trial judge then examined Grimm. The judge apparently had understood Grimm to have testified that the conditions he had observed in the women were not proved by any scientific study. Grimm clarified that point: Oh, we have elegant proof of the involvement of the eighth nerve, which is the inner ear, and I'm doing the science right now. I haven't published it yet, because I'm waiting to take a two-year look at this whole problem. You couldn't ask for betterfor better proof or better science at the present time with respect to inner ear function. What I don't understand yet is the mechanism for the other half of the equation, is the sensation. The judge asked Grimm whether his technique could be tested. Specifically, the judge asked whether Grimm had used a questionnaire because, if [you] have a questionnaire, they can look at that and see if you asked the right questions and what answers you got. Grimm responded that he had not used a questionnaire, but that he had used the classic technique of taking a careful clinical history. The judge asked Grimm whether he had submitted his notes and documentation for peer review. Grimm responded that [t]hese are studies in progress. I have not submitted this for publication, at which time a veryas you can understand, a critical review goes with a jury of my peers, on whether or not I have followed this very first rule of all clinical examinations. The judge asked Grimm whether his technique had a known or potential rate of error. Grimm responded that the potential error rate appeared to be about five to seven and one-half percent. According to Grimm, the laboratory data on balance was the best data in the world on measurement error in this business. The judge asked Grimm about the degree of acceptance in the relevant scientific community, widespread acceptance of your particular theory or technique. Grimm responded: I have no theory at the present time, and I haven't published a thing yet. I'm still in mythe studies are in progress. And I haven'tI presented this at a science fair from my own institution, which is sort of an annual program for work in progress, but I have not yet presented this data yet, because it's not complete, to any scientific meeting. The judge then asked Grimm about his sample group. Grimm noted that most of the 45 women he had examined had been referred to him by rheumatologists and immunologists who suspected neurological problems. About 25 percent were referred to him by attorneys. Grimm stated: They were sent to me very specifically. It's a very biased sample of people. The judge asked Grimm how he knew that the women were distinct from a cross section of the general population. Grimm responded that, in his practice, he had examined maybe 10,000 individuals for neurologic diseases. He added that he sees only patients who complain if something is going wrong with their machinery, in terms of balance or vision or whatever, that has to do with the nervous system. Generally, his patients have severe problems; general practitioners see patients with lesser problems. Finally, the judge questioned Grimm about his use of the word condition, rather than the word disease. Grimm explained: I think it's probably best to err on the conservative side of things. In the first stages of any observations, the first stage of science, is just to write down what you see and what you hear and what the evidence is, make as careful observations as you can and leave off the words that sort of prejudge, like a `disease.' If somebody has been intoxicated with somebody [ sic ] and has a set of neurologic symptoms and you take the thing that's intoxicating them and it gets better, you might not call it a disease but a disorder, dysfunction, or something like that. And I try to not use the emotional labels on it. A lot of those labels will prejudge a situation. Plaintiff's counsel then examined Grimm: Q.    [t]he methodology that you've employed in addressing questions for these 50 or so women, is all of that work based on generally accepted scientific principles and medical principles? A. I believe so, yes. Q. Is all of your examination technique based on standard neurological examination technique? A. Yes. Q. Is all of your sorting out and correlating and identifying of patterns and ruling out of other explanations based on standard medical and scientific principles? A. Yes. Q. So with respect to the route you've taken and the means you've used to get to your conclusions, you have no trouble saying that that is all based on accepted theory and technique? A. No. After extensive discussion with counsel, the trial judge announced his ruling: I don't have a problem with [plaintiff's] theory that [ State v. O'Key, 321 Or. 285, 899 P.2d 663 (1995)] doesn't apply to medical doctors who are coming in and giving a diagnosis based on their specialty. To the extent, however, that the diagnosis involves a new but unproven theoryproven, that is, by the O'Key methodsnot necessarily because the doctor says. It's proven to him O'Key says let's check it out. Has there been peer review? Has there been a methodology compared to samples? Has there been an error study done, so we know at least there's a possibility of error? Just seeing the 43 out of 45 doesn't mean that it's an absolutely perfect study.     [Grimm] can obviously say what he saw, and he can say that he's noticed a strong correlation between what he saw with [plaintiff] and what he has seen with some of his patients who have had silicone implants, multiple implants, and to that point I'm not seeing a serious problem. As soon as he takes it a step further and it looks like to the jury that there is a disease out there called silicone-related disorder and she has it, I'm a little bit concerned, because I don't see the O'Key test met, particularly when the doctor talks in terms of correlation. When he says it's a condition, not a disease, and you are asking him causation and he's explained to me why it's a condition at this point, because he doesn't want to use the word `disease' until he's further on in the studies (Emphasis added.) At that point, counsel interrupted the judge and the judge did not complete his thought. The judge then continued:  [Grimm] can testify to his observations of symptoms in [plaintiff]. He did examine her. I'll certainly take his word that he did a history; that he does, in his clinical practice that is an accepted method, a thorough history, did it orally without using a questionnaire, but I have no reason to doubt his ability to do it or his statement that it's a history that is well-accepted within certainly the neurological community. But he said he findsonce he checked those symptoms out and because he's seen similar symptoms in 45 of his 10,000 patients, he sees a pattern, and the last women he saw have had silicone implants. He sees the correlation, a strong correlation between those two symptoms, the pattern of those two symptoms and women who have hador at least the 45 women who have had breast implants.  But that's as far as I think he can go. To say that it's a cause of a disease that's undefinedwell, it isn't even a disease. Dr. Grimm can't say it's a disease and he doesn't yet understand the mechanism. Someday he will, but he doesn't yet understand the mechanism. I just don't think he can go any further than that. (Emphasis added.) Plaintiff's counsel asked the judge whether Grimm could opine that, more probably than not, plaintiff's two symptoms were caused by silicone. The judge answered:  No, I don't think he can say that. I think he can sayI think he can say what he did say. He did say in his diagnosis that there appears to be a strong correlation between women who have had silicone implantsat least these last few women he's look[ed] atwomen who have had silicone implants, there's a strong correlation, and these two symptoms, and he doesn't understand the mechanism of it, but between these symptoms, he's qualified to say that. That's what he did say. I don't have a problem with that.  But to stretch him and make it a causaluse that word, `There is such a thing as silicone-related disorder. I've examined [plaintiff] and she has silicone-related disorder based on my evaluations' I don't think he needs to go through the O'Key test as a medical doctor, but when he takes that one extra step and says, `What I observed in the symptoms belongs to this category,' when he says, `So far it's not a disease,' and so far he's still checking out things like error, peer review, things like that that still haven't happened, I think it would be inappropriate. (Emphasis added.) Plaintiff's counsel continued: I think what Dr. Grimm can do, and maybe we didn't really get to this point clearly, you know, he can say, `I see this correlation,' but thenif in terms of what willthen `Do you think that silicone is causing [plaintiff's] case,' he would say that `I put 25 or 30 possible causes on my differential, and I have systematically ruled them out and the only one that's left is silicone exposure.' And that, of course, makes it consistent withI mean, the correlation, then gives me the support. So there's actually two factors. The judge responded: As long as we don't get to the point that anyone mentions the word 90 or 95 percent type of thing, because that's only with these 45 women. It's not with all of the patients he has seen who have had whatever. I don't want the jury to believe that somehow this is a magic number, because I'm pretty certain it isn't.      At some point I don't mind getting the fact in front of the jury that I just mentioned, that small-level fact, and they can draw whatever inferences you argue to them or what they draw on their own. What I don't want to have happened is placed for them as a fact, by way of opinion, that based on the preliminary methods and the preliminary work that Dr. Grimm has done so far, he's in it for the Nobel Prize, and discovered a new disease and she has it.  There may come someday where there are established epidemiological studies and enough experts that can tie this and somebody can say it's a cause. I'm just a little concernedI mean, if you say, to a reasonable medical probability or scientific probability, is there a correlation between what you observed in [plaintiff] and a response to silicone, or something of that nature, I think I could be comfortable with that. A correlation is what he said. You can still use the reasonable medical probability if he's talking as a doctor doctor, and I think he is, because if we say scientifically probable, we trigger O'Key. (Emphasis added.) Plaintiff's counsel continued: [Grimm] is here, first and foremost, as a medical doctor. The judge responded: Okay. So if you say, `Doctor, to a reasonable medical probability, the symptoms that you have diagnosed in [plaintiff], you say to a reasonable medical probability there's a strong correlation between those symptoms and silicone'now, I may revise that in    a minute, but that sounds like something that I could deal with. He's not using the word `cause,' he's not say[ing] `the studies show' and he's not saying silicone-related disorders, but you said silicone exposure there's a strong correlation between the symptoms he's found and exposure to silicone, now that I think he can say, and I think    it will stand the test. But if you get too much further out of that, I'm going to be real concerned, because I do see somewhere a bright line where we get beyond his medical diagnosis into where he's given a scientific opinion as to the fact of silicone-related disorder and a direct causation of that disorder when we're so preliminary at this point. (Emphasis added.) Plaintiff's counsel then asked: What you're saying is he can say more probably than not there's a correlation, but he can't say more probably than not this is the cause THE COURT: Yeah. I think I could [Plaintiff's Counsel]:to a reasonable medical probability? THE COURT:to a reasonable medical probability. And I would let you lead on that point so that we don't go jumping around. In response to a request by defense counsel for cross-examination, the trial judge stated, in part: [W]e've got a potential of an opinion crossing a discipline from medical into more or less a scientific certainty. I think we're stopping short of that, and I think it's all right. As noted, the jury returned a verdict for defendants, and the trial court entered judgment accordingly. Plaintiff appealed, assigning as error, inter alia, the trial court's ruling excluding Grimm's causation testimony. The Court of Appeals reviewed the trial court's ruling as a matter of law and concluded that the trial court erred when it excluded Grimm's opinion testimony about causation. Jennings, 152 Or.App. at 429, 954 P.2d 829. The court explained: Whether Grimm's hypothesis is correct was a question of fact for the jury to decide in connection with the other evidence on the issue. In sum, we hold that Grimm's opinions meet the threshold requirement of logical relevance and that [defendant's] arguments go to the weight of the evidence and not to its admissibility. We conclude that the trial court erred when it excluded Grimm's opinion on causation.      [W]ithout Grimm's testimony as to the causation for the neurological disorders, plaintiff may have been unable to effectively rebut [defendant's] theory of the case that she suffered from fibromyalgia. In summary, the issue of causation was strongly contested throughout the trial with experts differing about whether the silicone that leaked from the implants was capable of causing plaintiff's complaints. The trial court's ruling effectively prevented plaintiff from offering testimony from a key witness about the issue of causation and that ruling may have affected the jury's view of the rest of plaintiff's evidence in light of the requirement that plaintiff had to prove her allegations by a preponderance of the evidence. On this record, we cannot say that there is `little likelihood' that the trial court's ruling affected plaintiff's case, and we conclude that a new trial is necessary. Id. at 430-31, 954 P.2d 829.