Ruff v. ENSIGN-BICKFORD INDUSTRIES, INC.

Citations: 171 F. Supp. 2d 1226; 2001 U.S. Dist. LEXIS 19926; 2001 WL 1485250Docket: 1:99-cv-00120

Court: District Court, D. Utah; October 25, 2001; Federal District Court

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The case involves plaintiffs Howard and Kay Ruff, Charles and Ellen Bates, and Rodney and Marilyn Petersen suing defendants Ensign-Bickford Industries, Inc., the Ensign-Bickford Company, and Mallinckrodt Inc., claiming that exposure to the toxin RDX from the defendants' explosives manufacturing plant caused their non-Hodgkin's lymphoma. The plaintiffs assert that RDX and its breakdown products contaminated local soil and water, ultimately entering their food sources.

The defendants filed a combined motion for summary judgment and to exclude the testimony of the plaintiffs' dose estimation expert, Shepherd Miller Inc. An evidentiary hearing was conducted to evaluate the admissibility of expert testimony under Rule 702 of the Federal Rules of Evidence and the standards established in Daubert v. Merrell Dow Pharmaceuticals.

Previously, the Court ruled to exclude testimony from Dr. Dennis Weisenburger regarding the likelihood of RDX alone causing the plaintiffs' cancers but allowed his opinion that certain breakdown products of RDX were likely causal. Dr. Weisenburger's conclusions were based on dose and exposure estimates provided by Dr. McLendon, who analyzed the environmental contamination and its impact on the plaintiffs. The Court reviewed various documents, expert opinions, and relevant scientific literature to reach its decision.

Dr. McLendon's dose estimations are founded on two scientific theories. The first theory posits that the explosive RDX degrades in the Mapleton environment according to a pathway identified by Dr. N.G. McCormick, which leads to specific first and second order degradation products. First order products include MNRDX, DNRDX, and TNRDX, while second order products, derived from these, include hydrazines, formaldehyde, and other nitrosamines. Analysis of Plaintiff Howard Ruff's well showed positive detections of first order products on two sampling dates (June 1998 and August 1999), but second order products were below detection limits, though presumed present based on the McCormick pathway. These concentrations informed Dr. McLendon's assessment of exposure through drinking water, fish, and contaminated produce. While defendants do not dispute exposure estimates from drinking water and fish, they contest those derived from fruits and vegetables, which Dr. McLendon identified as a primary exposure pathway.

The second theory asserts that RDX and its breakdown products accumulate in the tissues of contaminated plants, quantified by a bioconcentration factor (BCF). Dr. McLendon estimated a BCF of 9.7 for RDX, indicating it concentrates in plant tissues. The formula used predicts the concentration in produce based on groundwater levels and the BCF. A BCF greater than 1 signifies that the chemical concentrates in plant tissues, affecting exposure estimates from consumed fruits and vegetables. Defendants challenge the validity of both theories and Dr. McLendon's qualifications to provide dose opinions, asserting that his testimony does not meet the admissibility standards set by the Daubert ruling, although they do not dispute that the estimated doses could cause the alleged injuries.

The Court determines that Dr. McLendon is qualified to provide a dose estimation opinion, meeting the criteria under Rule 702 and Daubert standards. Despite defendants' claims regarding Dr. McLendon's lack of experience, his credentials were not challenged prior to the Daubert hearing. Dr. McLendon, Ph.D., serves as Vice President of Ecological Systems at SMI and has 28 years of experience in various ecological fields, including ecological risk assessment and chemical sampling. He has held faculty positions at multiple universities, authored over 50 publications, and conducted significant ecological research funded by governmental and private entities. Dr. McLendon has also taught courses related to ecological risk assessment and chemical sampling. His testimony included analysis of chemical degradation pathways for explosives, and he collaborates with chemists at SMI, particularly relying on Dr. Meyer for insights on the RDX degradation pathway. 

The Court dismisses defendants’ argument that Dr. McLendon lacks expertise with RDX, emphasizing a broader interpretation of Rule 702 that does not require an expert to have previously analyzed every chemical in question to qualify as an expert. The Court asserts that the threshold for admissibility of expert testimony is flexible, and the typical methods for challenging such testimony include cross-examination and the presentation of opposing evidence.

Amended Federal Rule of Evidence 702 allows expert testimony if it aids in understanding evidence or determining a fact, requiring that the expert is qualified and that the testimony is based on sufficient facts, reliable principles, and proper application of these principles to the case. The trial judge serves a 'gatekeeper' role, assessing the scientific validity and applicability of the expert's reasoning and methodology. Key factors for determining reliability include the testability of the theory, peer review status, potential error rates, and general acceptance in the scientific community. However, the Tenth Circuit emphasizes that strict adherence to all Daubert factors is not mandatory; it suffices that the expert's methods are those that other professionals in the field would reasonably use. In cases involving dose estimation, the expert must demonstrate the exposure level through independently validated techniques, including a clear description of the methods used. Defendants challenge Dr. McLendon's dose estimation, arguing that the McCormick degradation pathway lacks reliability and general acceptance and that his methodology does not appropriately connect to the case facts. The Tenth Circuit clarifies that an expert’s theory need not be undisputed or generally accepted to meet reliability standards, although such acceptance can support admissibility.

The Court concludes that the McCormick RDX degradation pathway is widely accepted within the scientific community and meets the reliability standards of Rule 702. This acceptance is supported by the defendants’ acknowledgment that McCormick’s model is the most cited regarding RDX degradation. Additionally, the defendants' expert, Dr. David Kaplan, has consistently referenced the McCormick pathway in his work, including a 1992 review that discusses RDX degradation into predictable products in anaerobic environments. Kaplan identified various intermediates formed during this degradation process, reinforcing the pathway's credibility.

Despite this, the defendants argue that Dr. McLendon's method is flawed due to his failure to consider newer scientific literature that purportedly revises the McCormick model. However, during a Daubert hearing, Dr. Kaplan could not recall any specific research teams that have revised McCormick’s model since its 1981 publication, contradicting the defendants' claim. The defendants have only cited one other author, Dr. Jalal Hawari, in two decades who has proposed an alternative degradation pathway. Thus, the Court finds ample evidence supporting the general acceptance of the McCormick pathway in the relevant scientific community.

Dr. Hawari's 2000 study indicates that the biodegradation of RDX in anaerobic sludge involves multiple pathways, including the McCormick and Hawari pathways. During cross-examination, Dr. Kaplan acknowledged that Dr. Hawari's pathway lacks general acceptance in the scientific community but conceded that both pathways could operate simultaneously. The court ruled that the relative weight of each pathway's significance pertains to the weight of evidence rather than its admissibility. It highlighted that Dr. McLendon's reliance on the established McCormick pathway, despite not considering the less accepted Hawari pathway, does not inherently discredit his opinion on dosage. The court noted that widespread acceptance, peer review, and testing are crucial for determining the admissibility of scientific evidence. The McCormick pathway has been published, peer-reviewed, and cited extensively, confirming its reliability. Dr. Kaplan acknowledged that the McCormick pathway had been validated by tests at three different sites. The court concluded that the McCormick pathway meets the reliability criteria of Rule 702. However, the defendants argued that the conditions in Mapleton differ from those in the McCormick study, questioning the relevance of the study to the current case. The court stated that relevance under Rule 702 requires a proper application of reasoning or methodology to the facts at hand.

The Court must assess whether the testimony assists the jury in resolving factual disputes, as established in Summers v. Mo. Pac. Railroad System. The McCormick study involved combining RDX with nutrients like beef extract, molasses, and sludge under anaerobic conditions. Dr. McLendon, a plaintiffs' expert, argued that these conditions mirror real-world environments, like that of Mapleton, where natural degradation occurs. The carbon source from molasses supports microbial growth, which accelerates RDX degradation, especially in oxygen-depleted soil.

Defendants' experts acknowledged in 1997 that RDX degrades in the Mapleton environment, producing toxic metabolites. Dr. Ronald Spanggord, hired by the defendants, confirmed the presence of first-order degradation products in water samples from the Ruff well in both 1998 and 1999. This indicates that RDX is degrading as predicted in the McCormick pathway. Furthermore, a peer-reviewed article reported similar findings from groundwater at the Cornhusker munitions site, reinforcing that RDX degrades in open environments like Mapleton.

The evidence supports that RDX degradation aligns with the McCormick pathway, and plaintiffs have substantiated their claims with scientific literature. Consequently, the Court concludes that the McCormick pathway is relevant under Rule 702, validating Dr. McLendon's application of this theory to the case facts.

Defendants challenge Dr. McLendon's application of stoichiometric equations to estimate the dose of RDX based on the McCormick pathway, arguing the pathway's reliability. The Court previously determined the McCormick pathway meets Rule 702 standards, thus upholding Dr. McLendon's stoichiometric method as scientifically valid. Regarding the Bioconcentration Factor (BCF) for RDX, defendants assert that Dr. McLendon did not use the most relevant studies for his BCF estimate. The Court finds that the choice of literature affects the weight of the evidence rather than its admissibility. Both experts, Dr. McKone for the defendants and Dr. McLendon for the plaintiffs, reviewed the same twelve BCF studies on RDX uptake in plants, which were all published and deemed scientifically valid. These studies included hydroponic, soil, and irrigation methodologies. Dr. McKone favored the Checkai and Simini irrigation study, estimating a BCF of 1, while Dr. McLendon selected data from hydroponic studies, yielding an average BCF of 9.7. Plaintiffs argue Dr. McLendon preferred hydroponic studies due to their relevance to the garden conditions.

The Checkai and Simini studies involved plant growth in uncontaminated soils, raising questions regarding their applicability to the plaintiffs' gardens, which contain contaminated soils. Dr. McKone confirmed that these studies started with pure, non-RDX containing soil, leading to a lower bioaccumulation factor (BCF) since RDX is absorbed from soil water rather than soil particles. Dr. McLendon explained that in clean soil studies, soil absorbs RDX, decreasing the concentration available to plants. Conversely, studies involving contaminated soils, where equilibrium is reached, show higher BCF values. Hydroponic studies, which measure direct water concentration, also support this finding, as they are not influenced by soil competition for RDX. The plaintiffs noted that Checkai and Simini used a less polar solvent, which further reduced RDX uptake. Dr. McKone acknowledged this but maintained that it was one isolated study. The court found Dr. McLendon's preference for hydroponic studies over irrigation studies reasonable, concluding that the relevance of the plaintiffs' expert's findings does not affect admissibility but rather the weight of the evidence. Dr. McLendon analyzed 12 studies, yielding 175 reported BCF values for RDX in plants, with 150 values greater than 1.0, indicating significant RDX uptake in many cases.

The average BCF (Bioconcentration Factor) for RDX is determined to be 9.7 based on a mean of 175 values, with higher BCF values typically associated with edible plant tissues. The supporting literature considers various factors such as plant tissue type, species, RDX concentration, soil organic matter, exposure duration, and transpiration. Specific vegetables from Mrs. Peterson's garden align with relevant BCF studies, reinforcing the findings. All experts, including Dr. Brian Murphy (defense consultant), reviewed the same scientific literature, applying similar methodologies to estimate BCFs. Murphy initially estimated a BCF of 50 in 1995, later revised to 12.5, and then to 1 after litigation began. Despite these changes, Dr. McKone acknowledged that Murphy's initial estimate is not "junk science." The Court finds it challenging to deem Dr. McLendon's BCF of 9.7 inadmissible, especially since Murphy's earlier estimate supports the validity of the BCF discussion. Dr. McLendon's preference for hydroponic studies over irrigation studies is deemed scientifically valid, and his BCF estimation is closely tied to case facts, aiding the jury in their deliberations. Additionally, McLendon suggests that the BCF for the breakdown products MNRDX, DNRDX, and TNRDX should equal that of RDX due to their chemical similarities.

For the first order degradation products of RDX, there are no empirical studies directly measuring bioconcentration factors (BCFs). Dr. McLendon assumed that the BCF for these degradation products would be the same as RDX, supporting this with their structural similarity and the expectation that as nitro groups reduce to nitroso groups, polarity decreases and the octanol-water partitioning coefficient (Kow) increases, thus likely increasing BCF. The Court found this assumption reliable and reasonable, noting that the expert testimony does not need to be irrefutable to be admissible. Defendants did not provide evidence contradicting the assumption that these degradation products are taken up by plants similarly to RDX. For other degradation products like hydrazine and formaldehyde, Dr. McLendon used the "Travis and Arms" equation, which is also the method used by the defendants' expert. This commonality in methodology supports the admissibility of Dr. McLendon's estimates. Additionally, the Travis and Arms equation is recognized within the scientific community and utilized by the EPA for risk assessments. The formulas employed by SMI align with those recommended by the EPA, further supporting their reliability.

Defendants argue that the Briggs' equation is more suitable for estimating bioconcentration factors (BCFs) for degradation products, although plaintiffs have already used this equation for RDX breakdown products with comparable results. The defendants did not provide sufficient justification for the superiority of the Briggs' equation over the Travis and Arms equation. The Court emphasizes that it does not need to determine which scientific formula is more accurate, as it is sufficient that plaintiffs' expert employed a scientifically valid equation to estimate BCFs. 

There are concerns regarding plaintiffs' decision to rely on historical dose estimates from literature instead of conducting direct tests on vegetables or soils from their properties. Plaintiffs claim they could not find a capable laboratory willing to perform such tests, noting that the Department of Defense employs labs for dose estimation but these labs are prohibited from testing for private litigation. Discussions during the Daubert hearing revealed that Midwest Research Institute (MRI) was considered for testing but deemed unreliable by plaintiffs. They were also unable to test fruits and vegetables prior to their NHL diagnoses and were waiting for promised tests from defendants related to the Utah Department of Environmental Quality, which ultimately were not conducted.

The reliability inquiry under Rule 702 focuses on principles and methodology rather than the conclusions drawn. Defendants' expert, Dr. McKone, asserted that testing is not a prerequisite for scientifically reliable dose estimation opinions. Consequently, the Court concludes that plaintiffs' lack of actual testing does not invalidate Dr. McLendon’s dose estimates under Daubert.

The Court denies defendants' motion for summary judgment and their motion to exclude Dr. McLendon's expert testimony, while also denying plaintiffs' motion to strike Dr. Brian Murphy's testimony. Defendants clarified that Dr. Meyer is not a subject of the motion, and Eric Woodland is not a designated expert but was a staff scientist at SMI when the original report was issued.

Magistrate Judge Alba determined that Mr. Woodland is not a designated expert for the plaintiffs, leading the court to interpret the defendants' motion in limine as applicable solely to Dr. McLendon. Although formaldehyde was identified as a breakdown product, Dr. McLendon’s dose estimate for it is deemed irrelevant since Dr. Weisenburger, the plaintiffs' medical causation expert, did not base his opinions on the probable exposures to formaldehyde. This irrelevance extends to liquid nitrate esters (EGDN, DEGDN, TMETN, BTTN) as well.

Dr. McLendon's dose estimates are contingent on proving, via transport expert Dr. Fred Marimelli, that the defendants' chemicals were transported to the plaintiffs' properties before their diagnoses. A Daubert motion to exclude Dr. Marimelli's testimony is currently under advisement. The excerpt explains that degradation refers to the reduction of chemical concentrations through transformation, with terms like "breakdown" and "biodegradation" used interchangeably by experts.

The Petersen well has not been tested for degradation products, and since RDX concentrations are similar in both the Ruff and Petersen wells, exposure concentrations for RDX degradation products for Marilyn Petersen were derived from the Ruff well. The Bates well has not been tested for RDX but shares similar construction and aquifer access with the Petersen well.

Defendants do not contest Dr. McLendon’s estimates for the liquid nitrate esters released from a faulty pond liner in 1986, indicating that even if the court grants the motion in limine, it would not warrant summary judgment as it does not affect nitrate exposure data, and Dr. Weisenburger can still link nitrates to NHL causation. Dr. Meyer, an unchallenged expert with a Ph.D. in fishery and wildlife biology and extensive experience in chemical degradation and risk assessment, supports the case with his credentials and published work.

There is confusion regarding whether the defendants’ RDX data originates from the Evans/Ruff or Young/Stephens well, with defendants asserting they are the same. Dr. McLendon’s statistical analysis shows comparable contamination levels in the Ruff and Petersen wells. Additionally, there is a discussion between Ms. Fields and Dr. McKone regarding the weight of hydroponic studies in calculating BCFs, with Dr. McKone suggesting they should be given less weight.

A series of studies and reports are cited regarding the phytoremediation of explosives-contaminated groundwater, focusing on the environmental behavior of munitions materials such as TNT and RDX in various plant systems. Key findings include:

1. **Phytoremediation Efforts**: Research conducted by Best et al. (1997) screened aquatic and wetland plants for their potential to remediate explosives-contaminated groundwater. 

2. **Environmental Fate**: Cataldo et al. (1990) evaluated how munitions materials behave in soil and plant systems, providing insights into the environmental fate of RDX.

3. **Crops' Response to Contaminated Water**: Checkai and Simini (1996) studied the effects of irrigation water containing low concentrations of RDX and TNT on crop health, highlighting ecotoxicological implications.

4. **Metabolic Fate in Plants**: Fellows et al. (1995) focused on the metabolic fate of TNT and RDX in plants, assessing how these explosives interact with plant genetics.

5. **Bioaccumulation Studies**: Harvey et al. (1995) explored the fate of RDX in soil and its bioaccumulation in bush bean plants.

6. **Transformation Products**: Larson et al. (1999) classified explosive transformation products found in plant tissues.

7. **Field Studies**: Price et al. (1997) examined plant uptake of explosives from contaminated soil and irrigation water at the former Nebraska Ordinance Plant.

8. **Detection of Plant Stress**: Simini et al. (1992) utilized chlorophyll fluorescence to detect stress in cucumber plants exposed to RDX.

9. **Translocation in Trees**: Thomson et al. (1999) investigated RDX translocation in poplar trees.

10. **Contaminated Plant Tissues**: Thorne (1999) assessed the fate of explosives in plant tissues during phytoremediation efforts.

Additionally, the excerpt includes calculations of bioconcentration factors (BCFs) for various vegetables grown in a garden in 1981, with Dr. McLendon determining an average BCF of 10.9 based on production estimates and relevant studies. The values demonstrate a consistent relationship with previous estimates, evidencing the potential for vegetable uptake of contaminants.