ORDER ON MOTION TO EXCLUDE THE TESTIMONY AND OPINIONS OF FRANK GARDNER, MARVIN LEGATOR, BARRY LEVY, MYRON MEHLMAN AND VERNON ROSE
On September 14, 1998, the parties consented to proceed before a United States magistrate judge under 28 U.S.C. § 636(c), for all further proceedings, including entry of final judgment. (Docket Entry # 7). Pending before the court is a request by Defendants Chevron USA, Inc. and Mobile Oil Corporation (collectively “Defendants”; “Chevron”/“Mobil”) to exclude the testimony and opinions of Frank Gardner, Marvin Legator, Barry Levy, and Myron Mehlman (Motion to Exclude the Testimony and Opinions of Frank Gardner, Marvin Legator, Barry Levy and Myron Mehlman [“Defendants’ Motion to Exclude”], Docket Entry # 21), and a supplement to that request, in reference to Vernon Rose. (Supplement to Defendants’ Motion to Exclude the Testimony and Opinions of Plaintiffs’ Expert Witnesses [“Defendants’ Supplement to the Motion to Exclude”], Docket Entry # 26). Plaintiffs have responded to these requests, and Defendants have filed replies. (Plaintiffs’ Response to Defendants’ Motion to Exclude the Testimony and Opinions of Frank Gardner, Marvin Legator, Barry Levy, and Myron Mehlman [“Plaintiffs’ Response to the Motion to Exclude”], Docket Entry # 22; Plaintiffs’ Supplemental Response to Defendants’ Motion to Exclude Plaintiffs’ Expert Witnesses [“Supplement to Plaintiffs’ Response to the Motion to Exclude”], Docket Entry # 31; Defendants’ Reply to Plaintiffs’ Response to Defendants’ Motion to Exclude the Testimony and Opinions of Frank Gardner, Marvin Legator, Barry Levy and Myron Mehlman [“Defendants’ Reply”], Docket Entry # 23). Further, each party has been given the opportunity to develop the evidence on these issues at hearings which took place on July 26 and August 16, 1999, and each has supplied the court with an index to excerpts from the relevant testimony and exhibits. (Docket Entries #33, #34, #38, #39, #41, #43, # 44). Following a review of the evidence submitted, the arguments of counsel, and the applicable law, the court ORDERS that Defendants’ motion to exclude the testimony and opinions of the designated expert witnesses is GRANTED. (Docket Entries # 21 and # 26)
Background
From the submissions, the court concludes that Kenneth Castellow died on April 12, 1996, less than one month after he was diagnosed as suffering from a blood disease. Plaintiffs have shown that Mr. Castellow worked for more than 30 years as a service station attendant, manager, or owner in either Chevron (as successor to Gulf Oil) or Mobil gasoline stations. Plaintiffs report that he worked at a full service Chevron station from 1958 through 1960, and at a full service Mobil station from 1972 to 1975. Both of those stations were located within the Houston city limits. In
To prosecute their toxic tort claim against Mobil/Chevron, Plaintiffs have hired several expert witnesses, including Frank Gardner, Marvin Legator, Barry Levy, Myron Mehlman, and Vernon Rose, to testify on the issue of causation. Each witness is presented in the hope that his testimony will establish proof on the claim that Mr. Castellow’s AML was caused by his occupational exposure to “benzene and benzene-containing products”, including gasoline, during the time he worked in, managed, or owned gasoline service stations in the Houston area.
(See
Plaintiffs’ First Amended Complaint [“Complaint”], Docket Entry # 14, pp. 2-3). Each of those witnesses has submitted at least one written report in support of his opinions.
(,See
Reports from Dr. Vernon Rose, Exhibits B-2, B-3, and B-4 to Plaintiffs’ Index, Docket Entry # 41; Report and Affidavit from Dr. Barry Levy, Exhibits C-2, C-3 to Plaintiffs’ Index, Docket Entry # 41; Report and Affidavit from Dr. Frank H. Gardner, Exhibits D-2, D-3 to Plaintiffs’ Index, Docket Entry # 41; Report and Affidavit from Dr. Myron Mehl-man, Exhibits E-2, E-3 to Plaintiffs’ Index, Docket Entry # 41; Report from Dr. Marvin Legator, Exhibit B-2 to Volume II of Defendants’ Exhibits in Support of
Daubert
Issues [“Defendants’ Exhibits in Support of Motion to Exclude”], Docket Entry #44). Upon receipt of the initial reports, Defendants moved to strike each designated witness, asking the court to rule that the proffered evidence does not meet the requirements of Federal Rule of Evidenoe 702, or the dictates of the United States Supreme Court decision,
Daubert v. Merrell Dow Pharmaceuticals, Inc.,
Defendants complain that the evidence submitted from each of Plaintiffs’ designated witnesses is unsupported in science, and in some instances, is unsupportable. Chevron/Mobil challenge whether the prospective causation evidence meets the requirements of either good science or law, and contend that it can be of no assistance to the triers of fact. Defendants’ fundamental complaint is that “[t]o be legally sufficient evidence, proof of causation requires a plaintiff to prove, at a minimum, exposure to the allegedly harmful substance at a level shown by scientifically reliable studies [to be] capable of causing the complained of ailment.” (Defendants’ Motion to Exclude, p. 12). The court agrees with Defendants that Plaintiffs have been unable to do so in this instance. From the record, as a whole, the court concludes that the disputed opinion evidence fails scrutiny under
Daubert.
Plaintiffs’ theory that Mr. Castellow developed AML as a result of his “cumulative exposure” to the benzene that is contained in
Standard of Review
Defendants insist that each opinion offered, to date, by Plaintiffs’ designated expert witnesses is inadmissible, as it fails the threshold requirements of Rule 702 of the Federal Rules of Evidence. Rule 702 reads as follows:
Testimony by Experts.
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.
Fed.R.Evid. 702. The opinion evidence tendered by Plaintiffs on the issue of causation is also subject to the interpretation of Rule 702 that is articulated in the United States Supreme Court decision,
Daubert v. Merrell Dow Pharmaceuticals, Inc.,
(1) Whether the theory or technique has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error of the method used and the existence and maintenance of standards controlling the technique’s operation; and (4) whether the theory or method has been generally accepted by the scientific community.
See Daubert,
The Fifth Circuit, in
Allen v. Pennsylvania Eng’g Corp.,
Discussion
Defendants here contend that, when scrutinized within the
Daubert
framework, the opinions submitted by Plaintiffs’ designated expert witnesses fail, and they must be excluded as they fall short of that rigorous analysis. In response, Plaintiffs insist that there are questions of fact present here, which arise from the source of the disputed opinions, and, as such, those questions affect, not the admissibility of the opinions, but the weight which should be assigned to them. In raising this argument, Plaintiffs are correct in cautioning that a trial court “should take care not to mistake credibility questions for admissibility questions.” (Supplement to Plaintiffs’ Response to the Motion to Exclude, p. 3);
see United States v. 14.38 Acres of Land,
It is probably important to note that when this lawsuit was first filed, Plaintiffs were relying upon an affidavit from one of Mr. Castellow’s former co-workers, Kenneth Driver, to help. prove that the deceased’s occupational exposure to benzene resulted in his illness and death. Kenneth Driver’s affidavit, stated, in unequivocal terms, that when he worked with Mr. Cas-tellow, it was common practice to use “pure” benzene, on a daily basis, to clean automotive parts. (Affidavit of Kenneth Driver, Exhibit I to Defendants’ Motion to Exclude, pp. 1-2). It seems universally accepted that daily exposure on that scale is a recognized health risk. Even Defendants do not dispute that such a practice could, in fact, result in dermal exposure to significantly harmful levels of benzene. Subsequently, however, Mr. Driver amended his statements about Mr. Castellow’s routine practices. When his deposition was taken, Mr. Driver testified that Mr. Castellow did not use benzene to clean automotive parts, but instead, he and the other service station attendants used a solvent which contained benzene as an ingredient. (Deposition of Kenneth Driver, Exhibit A-2 to Volume II of Defendants’ Exhibits in Support of Motion to Exclude, p. 20). He also reported that the benzene-containing solvent was a Mobil product
Mr. Castellow’s work-place exposures occurred over his 80 + years as a service station operator for Exxon, Gulf, and Mobil. Specifically, his exposures occurred during fueling, tank gauging, tanker-truck unloading, automotive repair and parts-washing operations. The primary source of benzene was gasoline (approximately 2.5% benzene by volume) although co-workers report the use in later years of some benzene-containing solvents during parts-washing operations.
(Affidavit of Dr. Frank H. Gardner, Exhibit D-3 to Plaintiffs’ Index, Docket Entry # 41, p. 3 ¶ 8). It appears that, since July 1999, the parties and experts have addressed the causation issues with that recitation as the boundary of Mr. Castellow’s occupational exposure to benzene.
From the current claims and defenses, the following points seem to be undisputed: (1) the relevant medical-scientific literature supports the conclusion that cumulative benzene exposure, at levels above 200 ppmyears, can result in acute myelogenous leukemia; (2) benzene is a constituent component of gasoline; (3) by virtue of his employment as a service station attendant, manager or owner, Mr. Castellow was exposed to gasoline, and its constituent, benzene; (4) no monitoring data exists for any of the service stations at which Mr. Castel-low worked during his employment. From those undisputed points, however, the parties’ contentions diverge greatly. In sum, Defendants contend that, although the scientific literature is relatively uniform in concluding that an exposure to a high volume of benzene can, in fact, result in AML, there is no scientific or medical literature to support the proposition that there is a sufficient level of benzene, as a constituent ingredient of gasoline, to result in a similar risk of AML by virtue of exposure to gasoline alone. (Defendants’ Motion to Exclude, p. 8). To support this contention, Defendants rely on, and cite, a number of scientific studies of petroleum distribution workers, or service station attendants, in which no statistically significant increase in the rate of AML has been traced to occupational exposure to gasoline.
In response, Plaintiffs argue that there is sufficient causation evidence to submit to a jury, and they point to an “exposure assessment” which was prepared by an industrial hygienist, Dr. Vernon Rose. In preparing his exposure assessment in this case, Dr. Rose relied on a “modeling formula” to calculate the level of benzene that Mr. Castellow encountered in his work life.
(See
Supplemental Report from Dr. Vernon E. Rose, Exhibit B-3 to Plaintiffs’ Index, Docket Entry # 41). Defendants’ objection to this proposed evidence by Dr. Rose is twofold: one, Defendants contend that when all is said and done, Mr. Castellow’s exposure was to gasoline, and perhaps a small constituent of benzene present in solvents, and that the medical literature does not support the conclusion that such an amount of benzene, from gasoline, is a recognized cause of AML. Second, even if such causal connection is supported by the medical and
The court is constrained to repeat here the details of each argument presented by the parties. However, after review of the extensive material submitted, including reference to each of the medical and scientific studies or writings submitted, the court finds that Defendants’ argument is well taken. In an exercise of its discretion, and in deference to the gatekeeping role imposed by Rule 702, the court finds that the evidence proffered by each of Plaintiffs’ expert witnesses should be excluded. It appears that the case which Plaintiffs have chosen to prosecute is a different case from the one lodged originally. It seems that Plaintiffs initiated this suit under the assumption that Mr. Castellow was exposed, daily, to pure benzene in his workplace practices. That assumption, arising from the Kenneth Driver affidavit, has since fallen by the wayside. From a review of all of the documents, the court is further convinced that the proposed expert witnesses began with the conclusion that Mr. Castellow’s AML was caused by exposure to harmful levels of benzene. From that conclusion they have “worked backward” to find medical and scientific support. Such a practice cannot withstand
Daubert
scrutiny and is not due any credence in a court of law. “The overarching goal of Daubert’s gate-keeping requirement ... is ‘to ensure the reliability and relevancy of expert testimony. It is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’ ”
Black,
The Relevant Scientific Literature
It is accepted that, in evaluating a purported causal link between a chemical agent and a particular disease, epidemiological studies are the most informative.
See Allen,
Opinions Tendered by Dr. Vernon Rose
It cannot be disputed that Plaintiffs are relying heavily on the calculations from Dr. Vernon Rose to link Mr. Castel-low’s blood disease to an exposure to Defendants’ products. Indeed, it must be emphasized that not one of the original reports submitted from Plaintiffs’ other
There appears to be little doubt that Dr. Rose’s original report, dated January 27, 1999, relied, unfortunately, but understandably, on Kenneth Driver’s affidavit which recited the use of “neat” benzene, on a regular basis, to clean automobile parts. (Preliminary Report from Dr. Vernon E. Rose, Exhibit B-2 to Plaintiffs’ Index, Docket Entry # 41, p. 4). Dr. Rose’s next report, dated June 21,1999, documents the first attempt by Plaintiffs to offer opinion testimony on the deceased’s quantified level of benzene exposure as a result of his work experiences with gasoline or benzene-containing solvents. It is that supplemental report which raises the most concern about Dr. Rose’s methodology and calculations. In the second report, and shortly thereafter, in his deposition, Dr. Rose retreated from his previous reliance on the Driver references to a pure benzene exposure. Instead, he posited an “exposure assessment” which was said to have been based on the deceased’s “cumulative occupational benzene exposure” from all of the employment tasks described over a 30-year span. (See Supplemental Report from Dr. Vernon E. Rose, Exhibit B-3 to Plaintiffs’ Index, Docket Entry # 41). In his second report, Dr. Rose calculated that cumulative occupational exposure to have been 177 ppmyears. However, that calculation was amended about one month later following the realization that it was premised on an error. Dr. Rose acknowledged that, according to the exposure levels for cleaning parts with gasoline, that were recorded in his second report, Mr. Castellow not only would have encountered a contemporaneous' exposure to gasoline in a potentially lethal amount, but also that such an exposure would have occurred twice daily, 250 days a year, for a ten-year period. (Deposition of Dr. Vernon E. Rose, Exhibit G to Defendants’ Supplement to the Motion to Exclude, pp. 176-77). Testifying about this report, Dr. Rose conceded that such a level of benzene exposure, as calculated, with the inescapable simultaneous exposure to gasoline, appeared to be “very high”, and gave him “pause” about the accuracy of his assessment. 4
In his third report, Dr. Rose estimated that Mr. Castellow met with 104 ppmyears cumulative occupational exposure to benzene. In this report, for the first time, Dr. Rose factored in the deceased’s “background exposure” to benzene. Again, following questions about both his methods and results, that assessment was revised. In his fourth report, Dr. Rose calculated a cumulative occupational exposure to benzene of only 61 ppmyears. In tracing the chronology of his calculations, Dr. Rose conceded that his exposure assessment has changed 300% from the first to the final report. (Transcript from hearing on August 16, 1999, Volume II, Docket Entry # 39, p. 132).
In calculating each of his exposure assessments in this case, Dr. Rose relied upon a “modeling” formula. Although Plaintiffs insist that the modeling technique is an acceptable scientific methodology and well suited to cases like this one, the court is not persuaded that the record supports that assertion when modeling is used to justify causation opinions in a tort claim. Plaintiffs have submitted a publication by the American Industrial Hygiene Association (“AIHA”) in which modeling is described and advocated. Plaintiffs rely on that article,
Modeling Inhalation Exposure,
written by Michael A. Jayjock, Ph.D., to bolster Dr. Rose’s reliance on that procedure in this matter.
See
Michael A. Jayjock,
Modeling Inhalation Exposure,
in The Ocoupational EnviRONMENt-Its Evaluation and CONTROL 313 (Salvatore R. DiNardi ed., 1997). But the thrust of the article appears to herald the importance of a modeling approach to risk assessment, not to causation factors in the legal setting. The article describes the modeling ap
investigating and seeking to understand the determinants of airborne contaminant source generation and control. As the critical variables governing the generation and control of airborne toxicants are discerned, the tools are formed that will build experience, knowledge-base, and confidence to predict actual concentrations and exposures in the real world with simulated scenarios.
* * * ❖ * *
Physical-chemical inhalation models are not limited to predicting present exposures. They can be used to estimate historical exposures that cannot easily be re-created and possible future exposures in hypothetical situations or scenarios. By employing a model, an occupational hygienist’s insight about possible exposures is enhanced, even if the model is not perfectly accurate. A noted and wise statistician, G.W.E. Box, has been credited with the profound observation that “all models are wrong, but some are useful.”
# ‡ ‡ ‡ % #
Thus, predictions from physical-chemical inhalation models can be extremely valuable; however, at this point these models are far from being considered elegant or complete. As such, they should be interpreted with caution and the usual judgment and intelligence that an occupational hygienist brings to his or her craft.
Michael A. Jayjock, Modeling Inhalation Exposure, in The Ocoupational EnvironMENT-lTS EVALUATION AND CONTROL 313, 315 (Salvatore R. DiNardi ed., 1997).
In the same article, Dr. Jayjock points out that inhalation models do not estimate human exposure “directly”, but instead estimate the concentration of toxicants in the air, and then
assume[s] that the person is breathing the same air with this concentration. The use of this and other assumptions is important and necessary in exposure assessment. ... Indeed, it is vital to the integrity of the process to sort out and identify each and every assumption used in modeling and estimation of exposure.
Michael A. Jayjock, Modeling Inhalation Exposure, in The Ocoupational Environment-Its Evaluation and Control 313, 316 (Salvatore R. DiNardi ed., 1997).
It is those very assumptions which Dr. Rose incorporated into his modeling formula that are so troubling in this case. Unfortunately, the discussion of Dr. Rose’s calculations is complicated by the fact that the modeling formula that he relies on was developed by a non-testifying expert, Dr. Melvin Kopstein. (Transcript from hearing on August 16, 1999, Volume II, Docket Entry #39, pp. 131-35, 179-183; Deposition of Dr. Vernon E. Rose, Exhibit G to Defendants’ Supplement to the Motion to Exclude, pp. 10-11).
Further, Dr. Rose acknowledged, as the Jayjock article suggests, that the model used in this case, and indeed the method as a whole, is intensely sensitive to a wide range of error depending on the exposure facts used in the modeling assumptions.
(See
Transcript from hearing on August 16, 1999, Volume II, Docket Entry # 39, p. 168). This “sensitivity” is especially significant because Dr. Rose testified that he made adjustments to his calculations on the basis of interviews that he conducted with Mr. Castellow’s former co-workers. He reported that, through these interviews, he was able to determine the exposures more accurately from their details about the deceased’s typical workday habits. (Report from Dr. Vernon E. Rose, Exhibit B-4 to Plaintiffs’ Index, Docket Entry #41, p. 1; Transcript from hearing on August 16, 1999, Volume II, Docket Entry #39, pp. 166-67). But crediting those adjustments raises special concerns here for two reasons. It is clear that the original assessments of the workplace exposure were based on Mr. Driver’s errone
Defendants also criticize Dr. Rose’s methods because he did not use, as the starting point for his calculations, the monitored exposure level data that is already available in the published literature. Instead, he resorted to modeling to calculate his “exposure assessment”. The court is persuaded that the pertinent scientific literature, cited by Dr. Irons, does reflect studies of workers with duties akin to Mr. Castellow’s, and that those studies contain comparable monitoring data. If comparable data from occupational exposure levels had been utilized, Dr. Rose’s assessment would have been spared the scepticism that has greeted it. The fact that Dr. Rose’s modeling calculations resulted in an estimated level of benzene exposure that would have resulted in simultaneous gasoline exposure at an explosive, if not lethally toxic, level underscores the unreliability of his selected methods. (See Transcript from hearing on July 26, 1999, Volume I, Docket Entry #33, pp. 85-91). Indeed, Dr. Rose recognized the fallacy of this approach and later introduced a “decay curve” to adjust his original exposure assessment calculations to allow for injurious levels of gasoline to dissipate, and ostensibly, to create a more realistic workplace exposure scenario. (See Supplemental Report from Dr. Vernon E. Rose, Exhibit B-3 to Plaintiffs’ Index, Docket Entry # 41). This adjustment illustrates the point that Dr. Irons made when he observed that modeling is not generally accepted as a substitute for data in a causation analysis. (See Transcript from hearing on July 26, 1999, Volume II, Docket Entry #34, p. 143). As Dr. Irons noted,
[mjodels are basically what people use in the absence of data. If you’re going to project a risk in a regulatory setting that attempts or purports to characterize a risk that cannot be measured experimentally or with data, then modeling is the only thing you can do. It doesn’t constitute evidence to use in determining causation. It’s a policy, not a science.
(See Transcript from hearing on July 26, 1999, Volume II, Docket Entry # 34, p. 143). He also testified, and, in general, this court agrees, that “data that is used in arriving at [a] causal inference in a scientific setting requires data, not modeling.” (See Transcript from hearing on July 26, 1999, Volume II, Docket Entry #34, p. 143). Finally, Dr. Irons emphasized that any model
that purports to use first principles to create data, I don’t believe is very useful. I think invariably it is inaccurate. Having said that, one should then at least apply a check with respect to what is plausible and what’s not. Does the model pass the laugh test? Does theresult that the model derives, is it compatible with life; is it compatible with anything else you physically can determine. If it doesn’t, then it obviously is not appropriate.
(See Transcript from hearing on July 26, 1999, Volume II, Docket Entry #34, pp. 143-44).
Although Dr. Rose testified to the assumptions that he made about the deceased’s daily tasks in order to calculate his exposure assessment, it is clear that some of those are not supported in the evidence. (See Transcript from hearing on August 16, 1999, Volume II, Docket Entry # 39, pp. 160-67). For instance, the assumptions Dr. Rose made in regard to Mr. Castellow’s exposure to benzene from cleaning parts with gasoline is not based on anything in the record. (See Transcript from hearing on August 16, 1999, Volume II, Docket Entry #39, pp. 162-67). On cross-examination, it became obvious that there is no record support for the assumed time and exposure levels Dr. Rose assigned to this task. Rather, as he testified, it was based on “just my impression ... of what the work situation was.” (Transcript from hearing on August 16, 1999, Volume II, Docket Entry #39, pp. 167). As even Dr. Rose admits that his modeling approach is extremely sensitive to fluctuations in data, it stands to reason that if the “data” from which his modeling assumptions arise is invalid, or non-existent, then there is no hope that his technique, much less his results, is going to be reliable.
Further, regardless of whether any of Dr. Rose’s assessments, as set out in his June 22, July 21, or July 25, 1999, reports are accurate, none of those reports ascribe to Mr. Castellow a level of benzene exposure that has been shown to result in AML in human beings. In his June 22nd exposure assessment, Dr. Rose found that Mr. Castellow’s workplace activities would have resulted in an exposure of 177 ppmyears of benzene. In his July 21st report, he calculated an exposure level of 104 ppmyears of benzene. And finally, his July 25th exposure assessment was calculated at 61 ppmyears of benzene. The court finds, however, that the relevant scientific/medical literature is conclusive only in documenting AML in human beings after benzene exposure levels reach beyond 200 ppmyears. See Mary B. Paxton et al., Leukemia Risk Associated with Benzene Exposure in the Pliofilm Cohort: I. Mortality Update and Exposure Distribution, 14 Akalysis 147 (1994); Otto Wong, Risk of acute myeloid leukemia and multiple myeloma in workers exposed to benzene, 52 OCCUPATIONAL AND ENVIRONMENTAL MEDICINE 380 (1995); Elsebeth Lynge et al., Risk of Cancer and Exposure to Gasoline Vapors, 145 American Journal of Epidemiology 449 (1997); Howard E. Runion, Benzene in Gasoline (1975) (unpublished study, Gulf Oil Corporation) (on file with the medical department of the Gulf Oil Corporation); Lesley Rushton and Helena Romaniuk, A Case-Control Study to Investigate the Risk of Leukemia Associated with Exposure to Benzene in Petroleum Marketing and Distribution Workers in the United Kingdom, 54 Occupational and Environmental Medicine 152 (1997); Otto Wong et al., Health Effects of Gasoline Exposure. II. Mortality Patterns of Distribution Workers in the United States, 101 Environmental Health Perspectives Supplements 63 (1993); Otto Wong et al., Nested Case-Control Study of Leukemia, Multiple Myeloma, and Kidney Cancer in a Cohort of Petroleum Workers Exposed to Gasoline, 56 Occupational and Environmental Medicine 217 (1999).
Without question the burden is on the proponent of evidence to prove its admissibility. Moreover, mere assurances by an expert witness as to the accuracy of his own methods or results, in the absence of other credible supporting evidence, is insufficient.
Black v. Food Lion, Inc.,
[Scientists whose convictions about the ultimate conclusion of their research is so firm that they are willing to aver under oath that it is correct prior to performing the necessary validating tests [may] properly be viewed by the district court as lacking the objectivity that is the hallmark of the scientific method.
Claar v. Burlington Northern Railway Co.,
Opinion Offered by Dr. Marvin Legator
Plaintiffs also named Marvin Legator, Ph.D., an environmental toxicologist, as an expert witness. Dr. Legator offered only one written opinion in this matter and it was rendered without the benefit of any assessment of the quantified level of exposure to benzene that Mr. Castellow might have experienced. {See Report from Dr. Marvin Legator, Exhibit B-2 to Volume II of Defendants’ Exhibits in Support of the Motion to Exclude). In addition to that failing, in his report, Dr. Legator never assigns a level of exposure that has been documented in the medical literature to result in a statistically significant excess of AML cases. {See Report from Dr. Marvin Legator, Exhibit B-2 to Volume II of Defendants’ Exhibits in Support of the Motion to Exclude).
Opinion Offered by Dr. Barry Levy
In support of Plaintiffs’ toxic tort claim, Dr. Barry Levy, an environmental health physician and epidemiologist, submitted two written opinions, a report dated January 26, 1999, and an affidavit, dated July 20, 1999. (Report and Affidavit from Dr. Barry Levy, Exhibits C-2, C-3 to Plaintiffs’ Index, Docket Entry #41). In his original report, Dr. Levy did not attempt to discuss the level of benzene exposure that has been reported in the available medical literature as likely to cause AML. In his amended report, submitted by affidavit, he clarified that the only quantitative information he had, in regard to Mr. Castellow’s level of exposure, is that which he derived from Vernon Rose’s calculations. (Affidavit from Dr. Barry Levy, Exhibit C-3 to Plaintiffs’ Index, Docket Entry # 41, pp. 3, 6). Further, Dr. Levy’s opinions were rendered without the benefit of Dr. Rose’s final revisions, dated July 25, 1999. When Dr. Levy was deposed, he stated that he received information from Dr. Rose, verbally, on the quantitative exposure assessment. But it seems that the information from Dr. Rose was given six months after Dr. Levy’s original report in which he expressed his opinion that Mr.
In his own January 26th report, Dr. Levy opined that Mr. Castellow had “extensive” exposure to benzene and benzene-containing products throughout his work life. (Report from Dr. Barry Levy, Exhibit C-2 to Plaintiffs’ Index, Docket Entry # 41, p. 3). It appears, however, that Dr. Levy’s assessment was due, in part, on his reliance on Kenneth Driver’s affidavit which erroneously described the deceased’s work habits.
At his deposition, Dr. Levy conceded that, in a published study of workers exposed to pure benzene, the results showed a statistically significant rate of AML only among those workers who had been exposed to levels of benzene of 200 ppmyears and beyond. (Deposition of Dr. Barry Levy, Exhibit C-5 to Plaintiffs’ Index, Docket Entry # 41, pp. 72-75). Dr. Levy also testified that if Mr. Castellow’s actual cumulative benzene exposure level was lower than that calculated by Dr. Rose, then he could not state, with reasonable scientific probability, whether that putative exposure was the cause of Mr. Castellow’s AML. (Deposition of Dr. Barry Levy, Exhibit C-5 to Plaintiffs’ Index, Docket Entry #41, pp. 122-24). Most importantly, Dr. Levy stressed that Dr. Rose’s calculations were very important to him in forming his opinion about the quantitative exposure to which the deceased had been subject. (Deposition of Dr. Barry Levy, Exhibit C-5 to Plaintiffs’ Index, Docket Entry # 41, pp. 9-11). Finally, Dr. Levy acknowledged that if Dr. Rose’s calculations were inaccurate, so that Mr. Castel-low was never, in fact, exposed to benzene at the levels calculated, then he could not offer an opinion as to causation. (Deposition of Dr. Barry Levy, Exhibit C-5 to Plaintiffs’ Index, Docket Entry #41, pp. 122-24).
It bears repeating that, at the time the expert witnesses, including Dr. Levy, gave their original reports, each was under the impression that Mr. Castellow used pure benzene, on a daily basis, to wash automotive parts. It seems that the bulk of Dr. Levy’s original report was centered on that assumption. Moreover, although Dr. Levy reported that he had reviewed the medical literature in support of his opinion that Mr. Castellow’s exposure history was consistent with benzene-induced AML, he was able to list only reports of benzene studies in which exposure levels were documented in workers other than service station attendants or mechanics. (Deposition of Dr. Barry Levy, Exhibit C-5 to Plaintiffs’ Index, Docket Entry # 41, pp. 74-75). In fact, originally, Dr. Levy did not cite any studies that dealt with reports of gasoline exposure at all, and his first report did not attempt to quantify the level of gasoline exposure, or the benzene constituent in gasoline, that has been shown in the medical/scientific literature to lead to AML. (See Report from Dr. Barry S. Levy, Exhibit C-2 to Plaintiffs’ Index, Docket Entry # 41).
Opinion Offered by Frank Gardner
Plaintiffs named Frank Gardner, M.D., as an additional expert witness on the element of causation in their toxic tort claim. Before rendering his original report, dated January 20, 1999, Dr. Gardner had not received any information about the level of benzene to which Mr. Castellow may have been exposed in his worklife. Dr. Gardner, therefore, formed his opinion that Mr. Castellow’s AML resulted from benzene exposure before he had reviewed any of Dr. Rose’s reports, including the supplemental corrections to his original exposure assessment. Although Dr. Gardner testified, at his deposition, that he relied on evidence about Mr. Castellow’s workplace exposure from the testimony and affidavits from co-workers, it seems reasonably clear that any information that he received from those sources cannot lend much retroactive support to his original
Dr. Gardner did agree, however, that “severe” health effects could result from Dr. Rose’s initial calculations of a gasoline exposure level of 10,000 ppm for five minutes, twice a day, over a work year. He also stated that, in his opinion, the acute effect of gasoline exposure of 59,000 ppm for five minutes would be lethal. (Deposition of Dr. Frank H. Gardner, Exhibit D-5 to Plaintiffs’ Index, Docket Entry # 41, pp. 24, 27, 28).
Dr. Gardner is an experienced and qualified internist who is well versed in hematology and oncology. (Affidavit of Dr. Frank H. Gardner, Exhibit D-3 to Plaintiffs’ Index, Docket Entry # 41, p. 1). The fact is, however, that his original report did not address any quantitative exposure on the part of Mr. Castellow, and that absence makes his opinion of questionable value in assisting the jury on the issue of causation. (See Report from Dr. Frank H. Gardner, Exhibit D-2 to Plaintiffs’ Index, Docket Entry # 41).
Expert Opinion from Dr. Myron Mehl-man
Once again, it appears that at the time that Myron Mehlman, Ph.D., made his report, in January 1999, he was operating under the erroneous assumption that Mr. Castellow habitually used pure benzene to wash automotive parts. Dr. Mehlman, a biochemist, who formerly served as director of toxicology and manager of environmental affairs for Mobil Oil, is eminently qualified in the relevant disciplines. (Curriculum Vitae of Dr. Myron Mehlman, Exhibit E-4 to Plaintiffs’ Index, Docket Entry # 41). However, he concedes that when he wrote his first report, he had no quantitative information, at all, about the level of benzene, or gasoline, to which Mr. Castellow had been exposed during his employment and he was relying on the Driver affidavit. (Deposition of Dr. Myron Mehlman, Exhibit E-5 to Plaintiffs’ Index, Docket Entry # 41, pp. 32-39). Further, at the time of his original report, and also at the time of his deposition, Dr. Mehlman was unable to provide any scientific references that document the level of exposure to gasoline that can cause AML. In fact, during his deposition, Dr. Mehlman was not able to cite any epidemiological cohort mortality studies in which the authors had concluded that gasoline exposure, at any level, led to AML. (Deposition of Dr. Myron Mehlman, Exhibit E-5 to Plaintiffs’ Index, Docket Entry # 41, p. 42).
Q: Can you name a single study in which the investigators or authors have concluded that gasoline causes acute myelogenous leukemia?
A: I haven’t searched for that yet, but I will do that.
Q: So as we sit here today, you cannot name a single scientific study in which the authors or investigators concluded that gasoline causesacute myelogenous leukemia in humans; is that true?
A: At the moment, that’s true, but I haven’t searched for that.
(Deposition of Dr. Myron Mehlman, Exhibit E-5 to Plaintiffs’ Index, Docket Entry #41, p. 43). Later in his testimony, Dr. Mehlman did cite one study, but conceded that it did not report a statistically significant excess rate of leukemia in persons exposed to gasoline, but instead, a statistically significant rate of excess for kidney cancer. (Deposition of Dr. Myron Mehlman, Exhibit E-5 to Plaintiffs’ Index, Docket Entry #41, p. 44). Further, Dr. Mehlman acknowledged that, to the extent that there was any reliance on European studies of workers exposed to the benzene component of gasoline, European gasoline generally contains a higher percentage of benzene than that in the United States. (Deposition of Dr. Myron Mehlman, Exhibit E-5 to Plaintiffs’ Index, Docket Entry # 41, p. 47). In sum, it is obvious that Dr. Mehlman rendered his opinion in the case without any information about the amount of benzene to which Mr. Castellow had been exposed from his lifetime work around gasoline.
Conclusion
Plaintiffs here have not shown that the relevant scientific or medical literature supports the conclusion that workers exposed to benzene, as a component of gasoline, face a statistically significant risk of an increase in the rate of AML. Further, there is no reliable evidence, before .this court on the amount of benzene, from gasoline or any other source, to which Mr. Castellow was exposed. In this case, given the
paucity of facts [Dr. Rose] had available about the level of [Castellow’s] exposure to [benzene-containing gasoline], his causation opinion would have been suspect even if he had scientific support for the position that the [gasoline] solution could cause [AML] in a worker exposed to some minor level of the [substance]. Under Daubert, “any step that renders the analysis unreliable ... renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.”
Moore,
In contrast, as discussed earlier, Dr. Rose’s reliance on statements by the deceased’s former co-workers to develop an “exposure assessment” is overstated and often unfounded.
(See
Deposition of Kenneth Driver, Exhibit H to Defendants’ Mo
Indeed, even more recently, in
Munoz v. Orr,
After a thorough review of all of the testimony, exhibits, and supplements, the court is led to the inescapable conclusion that the opinions from the expert witnesses in this case are unreasonably dependent on speculation about the cause of Mr. Castellow’s AML. The court finds further that Dr. Rose’s exposure assessment is not based on adequate data, but instead was devised to support a causation opinion without reliable bases to do so. His methodology, therefore, is not reliable and his testimony is inadmissible. In the absence of sufficient, accurate information of exposure levels, his opinion is nothing more than speculation. Such result-driven procedures are anathema to both science ánd law and are properly excluded because they are too speculative to assist the triers of fact in determining the cause of Mr. Castellow’s illness. In addition, the court finds that the other expert witnesses, eminently qualified as each is in his own field, depend on Dr. Rose’s exposure level calculations to provide the causal link to Defendants’ products. That causal link' fails. In that regard, the court has come to the reluctant conclusion that Defendants are correct when they state that “Plaintiffs’ experts have worked backwards from the exposure conclusion they needed.” (Defendants’ Supplement to the Motion to Exclude, p. 9). In making that assessment, the court is not, as Plaintiffs argue, requiring them to produce a “precise level” of benzene exposure. Instead, the court is merely requiring them to produce information, adequately supported, from which Dr. Rose, and the others, can make a causal connection.
Rule 702 “contemplates some degree of regulation of the subjects and theories about which an expert may testify”, and that testimony must be based on a reliable foundation.
Moore,
From the record, as a whole, the court concludes that the proffered testimony fails scrutiny under Daubert. Plaintiffs’ theory that Mr. Castellow developed AML as a result of “cumulative exposure” to benzene-containing gasoline is not supported by the relevant scientific or medical literature. The pertinent studies show that persons exposed to gasoline, by occupation, do not reflect a statistically significant excess rate of AML, or even leu-kemias generally. Insofar as Plaintiffs hope to establish a causal link by calculating a risk of exposure consistent with the medical literature, the reliance on Dr. Rose’s formula is misplaced. In the absence of credible evidence that Mr. Castel-low was exposed to quantities of benzene that are sufficient to result in AML, Dr. Rose’s speculative opinions will not suffice to sustain Plaintiffs’ burden. After a careful review, the court concludes that Dr. Rose’s testimony is not reliable and should not be presented to the jury, backed as it will be, by his estimable credentials as a well trained and long-experienced industrial hygienist. It bears repeating that the gatekeeping function, which precedent imposes on this court, requires
some objective independent validation of the expert’s methodology. The expert’s assurances that he has utilized generally acceptable scientific methodology is insufficient. The proponent need not prove to the judge that the expert’s testimony is correct, but ... must prove by a preponderance of the evidence that the testimony is reliable.
See Moore,
The court finds, therefore, that the opinions offered by Plaintiffs’ expert witnesses are not reliable as they posit a theory that is not generally accepted (exposure to gasoline causes AML); that their particular hypothesis in this case has not been subjected to testing or peer review; and most importantly that, here, the result driven methodology (modeling to determine exposure assessment) is rife with error and speculation. For all of those reasons, the proffered opinions do not meet the Dau-bert standard and they should be excluded. Based on the discussion herein, the court GRANTS Defendants’ motion to exclude the testimony offered by Levy, Gardner, Legator, Mehlman and Rose. Absent any evidence to establish a causal link between Mr. Castellow’s death and Defendants’ products, Plaintiffs’ evidence fails and the case is subject to summary judgment. By separate order, that motion is also GRANTED.
The Clerk shall enter this order and provide a true copy to all counsel of record.
Notes
. From all sources, the court concludes that the solvent at issue is most likely the Mobil product, Solvasol, which is said to contain less that 7 ppm benzene. (Deposition of Aubrey Brown, Exhibit C-l to Volume I of Defendants’ Exhibits in Support of the Motion to Exclude, p. 13; Deposition of Wilford Swank, Exhibit A-5 to Volume II of Defendants' Exhibits in Support of the Motion to Exclude, p. 30; Transcript from hearing on August 16, 1999, Volume II, Docket Entry # 39, p. 137).
. Dr. Irons summarized the Bradford-Hill criteria as demanding scrutiny on a number of factors before any causation conclusion is appropriate: (1) a determination of the strength of the evidence of any association in the quantitative epidemiological literature, (2) whether the association is capable of being reproduced and been consistently observed in different quantitative epidemiological studies, and by different investigators, (3) whether the association is specific with respect to a given chemical’s risk factor and a particular disease, (4) whether the temporal relationship between the exposure and risk of the disease is a factor, (5) what the dose-response relationship is between the exposure to the chemical and the risk of developing the disease, (6) whether there is a plausible biological reason to explain the risk factor in causing the disease, (7) whether the hypothesis makes sense in terms of the history and biology of the disease, and (8) whether alternative mechanisms or known risk factors exist that have a potential impact on the disease or could confound the interpretation of the results. (Affidavit from Dr. Richard D. Irons, Exhibit B to Defendants’ Motion to Exclude, pp. 3-4).
. Dr. Irons identified those published reports that are the most relevant to Mr. Castellow’s workplace environment. These were reportedly selected because the tasks studied were the most similar to the deceased's daily work. After reviewing the literature submitted by both parties, the court agrees that the studies selected by Dr. Irons more closely track Mr. Castellow’s workplace exposure. See Mary B. Paxton et al., Leukemia Risk Associated. 'with Benzene Exposure in the Pliofilm Cohort: I. Mortality Update and Exposure Distribution, 14 Analysis 147 (1994); Otto Wong, Risk of acute myeloid leukemia and multiple myeloma in workers exposed to benzene, 52 Occupational and Environmental Medicine 380 (1995); Else-beth Lynge et al., Risk of Cancer and Exposure to Gasoline Vapors, 145 American Journal of Epidemiology 449 (1997); Howard E. Runion, Benzene in Gasoline (1975) (unpublished study, Gulf Oil Corporation) (on file with the medical department of the Gulf Oil Corporation); Lesley Rushton and Helena Romaniuk, A Case-Control Study to Investigate the Risk of Leukemia Associated with Exposure to Benzene in Petroleum Marketing and Distribution Workers in the United Kingdom, 54 Occupational and Environmental Medicine 152 (1997); Otto Wong et al., Health Effects of Gasoline Exposure. II. Mortality Patterns of Distribution Workers in the United States, 101 Environmental Health Perspectives Supplements 63 (1993); Otto Wong et al., Nested Case-Control Study of Leukemia, Multiple Myeloma, and Kidney Cancer in a Cohort of Petroleum Workers Exposed to Gasoline, 56 Occupational and Environmental Medicine 217 (1999).
.
Q: What would be the gasoline exposurebe [sic]?
A: Right. About 59,000 parts per million.
Q: For five minutes?
A: Right.
Q: Twice a day under your analysis if the ambient temperature was 85 degrees?
A: Correct. Once in the morning and once in the afternoon.
Q: What would the effects — do you know what the effects of almost 60,000 ppm gasoline would be on someone over five minutes?
A: No, Sir, I don't. The only — and I haven't reviewed this literature for the — for purposes of this case. The only thing I have seen is — that I remember seeing in all this literature is Runion's paper—
A: Yeah, I think so. He comes up with a range of — of five to 16,000 parts per million gasoline vapors as lethal in five — exposure time of five minutes.
Q: And it's your opinion, based on the assumptions you've made, that twice a day for a period of time equivalent to ten years for 250 working days a year during that ten-year period Mr. Castellow had those sorts of gasoline exposures; is that true?
A: I would say those would appear to be very high.
Q: It would have knocked him over right there, wouldn't it?
A: From the one reference, Reference 13, and there are — I'm sure there’s more literature than this but I haven’t looked at — • there is a 1961 publication that is referred to. So, we have one publication that says that, that is correct.
Q: In fact, to be accurate, that publication says that a level less than a fourth of your estimate would have been lethal in one five-minute period, not two a day, 250 days a year, for ten year, true?
A: That’s true.
Q: Do you have some information that Runion’s acute gasoline exposure data— health effects of acute gasoline data are incorrect?
A: I have no other information whatsoever, one way or the other.
Q: Would that cause you some pause about the calculations you have made related to gasoline exposure while cleaning auto parts?
A: Yes, sir. I think if that — if that were a docu [sic] — an accepted level, it would.
(Deposition of Dr. Vernon E. Rose, Exhibit G to Defendants’ Supplement to the Motion to Exclude, pp. 177-78).
