Deborah Kay Harris, Administratrix v. CSX Transportation

753 S.E.2d 275 HARRIS, Kay Administratrix of

Deborah Harris, De- the Estate of Ronald K. ceased, Below, Plaintiff Petitioner TRANSPORTATION, INC.,

CSX Below,

Defendant Respondent. No. 12-1135. Supreme Appeals Court of Virginia.

West Submitted Oct. 2013. Decided Nov. Hartley, Magers,

R. Dean Julie R. J. Mi- Prascik, O’Brien, P.L.L.C., Hartley chael & WV, Wheeling, for Petitioner. Turner, Johnson, Steptoe

James W. & WV, Huntington, Tauber, Andrew E. Brian LLP, Wong, Mayer J. Brown Washington, D.C., Respondent.

DAVIS, Justice: Hams, Kay Deborah administratrix of (“Petitioner”), K. Harris Estate of Ronald appeals an order Circuit Court of County granting summary judg- Marshall of CSX Transportation, ment favor Inc. (“CSX”). granted The circuit court sum- mary judgment ruling after that Petitioner calling from precluded expert was her three dispositive pre- witnesses at trial. issue by appeal sented the Petitioner in this is whether the circuit court committed error finding testimony the scientific of Petitioner’s Af- three witnesses was not reliable.1 briefs, ter a careful review of the the record appeal listening submitted on arguments parties, we reverse remand case.

I. AND

FACTUAL PROCEDURAL HISTORY originally by was filed action Ronald Employers’ K. Harris under the Federal Lia- bility Inspection Act2 and the Locomotive against employer, Act3 his CSX.4 The com- (1994). assign- § seq. 1. The Petitioner set out three 0701 et issues only See 49 U.S.C. However, of error. we to ad- ments need testimony reliability the issue of the dress appeal 4. The record submitted on did not include experts of Petitioner’s to resolve this case. complaint. (1939). seq. § U.S.C. 2. See 45 51 et entry summary judgment re- exposure Mr. court’s alleged that Harris’

plaint employed while CSX parties agree. fumes de With- diesel exhaust viewed novo." type Petitioner, called develop of cancer caused him to out pend- multiple myeloma. While the ease summary judgment appropriate. Conse- cancer. as a result of the ing, Mr. Harris died ruling dispositive case is quently, in this Petitioner, wife and administra- Harris’ Mr. summary judgment It is the not the order. estate, as the was substituted trix of his precluding Petitioner’s three orders complaint amended plaintiff. Petitioner fail, If those sum- testifying. from orders allege Mr. Harris’ death resulted mary judgment appropriate. is not fumes.5 to diesel exhaust from his expert witness matter, concluded parties long When the general As a have we the discovery, to exclude filed motion CSX admissibility testimony by “[t]he held that of expert wit- testimony three of Petitioner’s expert witness is a matter within the an methodology was their nesses because court, trial the discretion of the sound CSX, request the of trial reliable. At will reversed trial court’s decision not be evidentiary regarding hearing court held an 6, clearly wrong.” Syl. pt. Hel unless it expert wit- admissibility of Petitioner’s Co., 269, mick v. Potomac Edison 185 W.Va. hearing testimony. evidentiary The nesses’ (1991). However, we have 406 S.E.2d 700 During hearing, days. two Peti- lasted indicated, hold, a circuit so “when Dr. Peter experts, her three tioner called testimony expert court excludes as unreliable Goldstein, Infante, Ph.D.; Dr. Ph. Lawrence Merrell [Daubert under the v. Dow Pharma Durie, D.; and M.D. CSX called Dr. Brian 579, ceuticals, 2786, Inc., U.S. 509 113 S.Ct. Shields, expert two witnesses: Dr. Peter (1993); L.Ed.2d v. Burack 125 469 Wilt Green, These and Dr. Laura Ph.D. M.D. (1993),] er, 39, 191 W.Va. 443 S.E.2d 196 evidentiary hearings Virginia in West analysis, we will the cir gatekeeper review commonly referred to “Daubert/Wilt” analy conducting the cuit court’s method of hearings. Wendy’s novo." v. sis de San Francisco two-day eviden- At the conclusion Inc., 734, Int’l, 740, S.E.2d 221 W.Va. 656 three tiary hearing, the circuit court entered (2007) (citations omitted). excluding experts’ testi- orders Petitioner’s mony. findings The court circuit entered mind, these we turn to With standards which, essence, that Peti- fact determined presented by this appeal. the issues prove to the that diesel tioner failed to court myeloma. multiple exhaust causes III. having expert, Peti- As a result of not an agreed jointly move tioner CSX for DISCUSSION summary judgment favor so that CSX’s expert appeal Petitioner the adverse could disposi- adequately In order to address entered rulings. witness circuit court give guidance issue in case and tive summary granting judgment. order an judges in future cases trial similar appeal followed. matter, instant we have outlined our discus- (1) general principles Rule sion as follows: II. (2) (3) 702; multiple myeloma; nature (4) toxicologi- epidemiological methodology; OF STANDARD REVIEW (5) methodology; weight of the evidence cal In this circuit court proceeding, (6) methodology; methodology; Bradford Hill granted summary judgment in favor of CSX (7) methodology qualification, opinion of testimony excluding after of Petitioner’s (8) witnesses; expert circuit Syllabus expert witnesses. We stated excluding testimony Pe- orders court’s point Peavy, of Painter v. 192 W.Va. (1994), experts. circuit titioner’s “[a] 451 S.E.2d 755 part appeal. complaint the record on 5. The was not made amended Principles expertise A. General of Rule area of particular covers the opinion expert as to which the seeks to Virginia Rule 702 of the West testify. that, provides in “[i]f Rules of Evidence full 195 W.Va. 466 S.E.2d 171. scientific, technical, specialized or other knowledge will assist the trier of fact general standard determining understand the evidence or expert’s to determine a whether an opinion scientific is rele- issue, qualified expert fact in witness as an vant and reliable Syllabus was set out in skill, Buracker, knowledge, experience, training, point 2 of Wilt v. 191 W.Va. may testify education thereto in the form of 443 S.E.2d 196: or otherwise.” “Rule 702 reflects analyzing admissibility attempt governing to liberalize the rules testimony under Rule 702 of the West admissibility testimony.” Virginia Evidence, Rules of the trial Co., Weisgram, Marley 169 F.3d inquiry court’s initial must consider wheth- (8th Cir.1999). What this means is that testimony er the is based on an assertion admissibility rule ‘is one of “[t]he rather than or inference derived from the scientific Litig. exclusion.’” In re Flood Coal River methodology. Moreover, Watershed, 574, 581, 222 W.Va. S.E.2d must be relevant to a fact at issue. Fur- 203, (2008) (quoting 210 Arcoren v. ther United assessment should then be made in States, 1235, (8th Cir.1991)). regard expert 929 F.2d 1239 testimony’s reliability “Disputes strength considering expert’s underlying as to the of an its scientific credentials, methodology reasoning. in mere differences the method This includes (a) ology, an authority or lack of textual for the assessment of whether the scientific theory opinion go weight and not to the admissi its conclusion can be and have (b) tested; bility testimony.” Gentry of their been [sic] v. the scientific the- 512, 527, Mangum, ory subjected peer 195 W.Va. 466 S.E.2d has been review and 171, 186 (1995)(citation omitted). (e) publication; whether the scientific theo- ry’s potential actual or rate of error is “explained The decisions of this Court have known; (d) and whether the scientific theo- two-part that circuit courts must conduct a ry generally accepted is within the scienti- (1) inquiry under Rule 702 and ask: is the community. fic and, so, [qualified expert; witness an as] if (2) As expert’s testimony opinion, is the is illustrated later in relevant and Int’l, the trial reliable?” San court’s decision to exclude Wendy’s Francisco v. Petition Inc., 741, experts er’s three 221 resulted from W.Va. at 656 S.E.2d at its determi 492 (citations omitted). nation that opinions the scientific of all See three also Robin Jean Davis, of Petitioner’s Admitting Expert were not reliable. Testimony in Fed- ruling The circuit court’s Impact eral Courts shows a misunder Virginia and Its on West standing Jurisprudence, 485, meaning of the “reliable” under W. Va. L.Rev. (“Trial (2002) Virginia jurisprudence. required previously courts are West to assess We expert testimony meaning have noted the contours relevancy scientific of the ” reliability.”). Syllabus “reliable’ as follows: point Gentry In 5 of steps we set out the that a trial court should scientifically- The assessment of whether expert take to if qualified determine an is “reliable,” testimony based is render an under Rule 702: that term in is used [Daubert Merrell In determining expert, Pharmaceuticals, Inc., who is a cir- Dow 509 U.S. cuit step 2786, 125 (1993), court should conduct a inqui- two 113 S.Ct. L.Ed.2d 469 First, ry. Buracker, a circuit court must determine v. Wilt 191 W.Va. 443 S.E.2d (a) (1993) proposed expert ], whether the meets the does not mean an assessment minimal educational experiential qualifi- or testimony of whether persuasive, is (b) cations in a field that Rather, is relevant to the convincing, or well-founded. as (c) subject investigation under sessing “reliability” which will is a shorthand term of Second, assist the trier of fact. a circuit assessing testimony art for whether the is court must expert’s determine that degree to a reasonable based on the use of ex rel. Wiseman v. been The decision State procedures that have

knowledge and Henning, 212 569 S.E.2d methods of science— W.Va. using the arrived at (2002), hostility to irrational and illustrates this Court’s being based on than rather jury stripping litigants right to have guesses, speculation. feelings, intuitive case, wrong. jury right or The decide if an then If the former is discretion) (or not, injured in an auto- plaintiff Wiseman may in its sole may multiple developed and later testimony. accident mobile “rely upon” the negligence myeloma. plaintiff The filed a at 582 n. Litig., 222 W.Va. In re Flood driver and truck against the truck action 211 n. 5. 5.E.2d at owner, multiple myeloma alleging that his Cleckley made Gentry, Justice injury cage from a rib he suffered resulted observation: following relevant with the truck driver.6 in the traffic collision Daubert/Wilt, the circuit court Under granted defendants’ motion The circuit court validity inquiry into the conducts plain- in limine to exclude science, looking the sound- at underlying expert witness on causation. tiffs theories and the principles or ness of the prohibi- petition for a writ of plaintiff filed a process or method as reliability of the seeking prevent en- with this Court tion problem is not to applied in the case. The order. This of the trial court’s forcement proffered evidence is whether the decide concluding that granted writ after Court is valid right, but whether the science expert’s proffered opinion was suf- plaintiffs enough to be reliable. opin- ficiently to be admissible. reliable at 182 Gentry, 466 S.E.2d 195 W.Va. as fol- addressed the issue ion Wiseman noteworthy It (emphasis original). lows: important to itali- Cleckley felt it was

Justice Examining the record in the instant prob- “The quoted sentence: cize the second case, court ex- believe that the circuit we proffered decide whether the lem is not to authority to ex- its in its decision ceeded the science is right, but whether evidence is testimony Dr. Hussein. The clude the of enough Id. As will be to be reliable.” valid that Dr. Hussein was record reflects circuit court opinion, later in this the shown re- specialized cancer member of several Gentry. opinion in misapplied this Court’s societies, inter- and had substantial search is, opinions the That the circuit court decided specialists. He action with other cancer wrong. were three from Petitioner’s such as that specialist cancers was a Gentry, right wrong is not an issue Under or Wiseman, was di- by Mr. and suffered evidence. admissibility of scientific of the Myeloma Program at the rector of right wrong a court made The circuit proffered Hussein’s Cleveland Clinic. Dr. of scientific test for the admission central myeloma can result multiple opinion that so, doing the circuit court re- evidence. upon: based his ex- from a trauma was jury its exclusive role of moved from the Wiseman; Mr. his tensive treatment of expert opinion to believe. deciding which patients at the treatment of other five had trauma-induced Cleveland Clinic who of this Rule 702 and decisions physiological myelomas; study of the his clearly that it is of no moment Court state injury causing chronic process of tissue parties’ experts reach opinions that the of the cells, and overstimulation of inflammation dispositive on all issues. different conclusions triggers growth of cancerous system which expected. legal Our is This is to be cells; specialists adversarial, his interaction with other of the not cordial. As a result trigger that trauma can system, who also believe legal we adversarial essence of our myeloma; and the of ultimate the occurrence rely upon jury to make the published other can- handful of expert right is and determination as to which tis- that have identified local cer centers expert wrong. place To the decision which is fracture, as a injury, including a bone litigants sue judges denies in the hands of trial myeloma. causing multiple jury risk factor for right to a trial. their constitutional plaintiff’s brought by wife. A claim was also loss of consortium opinion Adams, recognize that Dr. Hawaii Serv. Ass’n v. Ha- Hussein’s Med. We unorthodox, may (Ct.App. and not have waii 209 P.3d 1263 n. 4 is novel 2009). found, received, During underlying proceedings yet as the circuit court herein, Myeloma acceptance multiple com- was “general the scientific described CSX, Shields, However, Evidence for munity.” Rules as follows: require opinion be that a scientific do not multiple myeloma So is a cancer of one accepted,” a re- “generally because such types actually of blood cells. It’s at with thrust quirement is odds the liberal cells, plasma cell, which type is a of B ap- general ... Rules and their plasma cells are responsible mak- for proach relaxing the traditional barriers ing fight antibodies infection. what And testimony. suggests opinion record you happens get myeloma, that if all is underly- degree reliability a substantial cell, plasma type plasma cells or one opinion. formation of Dr. ing the Hussein’s actually growing uncontrollably started Accordingly, court we find that the circuit pushing everything out ... testimony----The in excluding his erred enough to be proffered is valid

reliable; proffered whether the evidence is plasma ... cell is So one of the —is one right question part of the blood cells that’s of the immune of fact. finder system fight, that makes those antibodies Wiseman, 133-34, S.E.2d at W.Va. know, cold, you pneumonia, common (internal quotations citations 209-10 thing. that sort of added).7 omitted; emphasis Ruiz- See also Pepsi Bottling Cola Puerto Rico Troche happens And so what is as cells those (“Daubert (1st Cir.1998) Co., F.3d cells, plasma grow, plas- those and become proffers require party that a who does not macytomas; they where like live ... in the testimony cany proving the burden myeloma. bones. And so that’s the So judge expert’s that the assessment part bones, myeloma is the and multi- correct.”). the situation is ple you get multiple bone And lesions. bones, living it’s in the it’s —as it starts Multiple Myeloma Nature B. The marrow, you crowding up the bone judice, case Mr. In the sub Harris other having start bood count You effects. myeloma. diagnosed having multiple system problems have immune and that from this disease. has He died This disease thing. sort of as been described follows: State, 57, Toney See v. 961 N.E.2d 60 also “[Mjultiple myeloma is a of the cancer (“[M]ultiple myeloma a (Ind.Ct.App.2012) [is] cell, plasma a cell which bone arises marrow.”); plasma cancer cells in of the bone and of the important part maiTow is an Inc., Superior Grp., Williams v. Uniform system provides immune as it antibodies 244, (“Multi (La.Ct.App.2003) 847 So.2d 246 help fight infection other dis- which and ple myeloma type ais of cancer that affects plasma malignant, If a cell eases. becomes marrow, body’s blood-forming bone myeloma it a cell. An individual is called system.”). myeloma build-up an of with has abnormal myeloma cells in the bone marrow Epidemiological Methodology C. displacement of normal marrow and which destroy in tumors that results involve and Infante, experts, One of is Petitioner’s surrounding bone. epidemiologist. Epidemiology an to “refers Found., City No. World Inc. v. science that studies the distribution Sacchetti 114829/03, 344131, (N.Y.Sup. populations[.J” 2008 WL at *4 diseases within v. Chesson 28, 2008). 346, Specifically, ‘“[m]ultiple Co., Ct. Jan. Montgomery Mut. Ins. 434 Md. 75 (2013) (internal 932, myeloma’ presence refers to the quotations of numerous A.3d 939 omitted). Moreover, myelomas body.” in various bones of the citation ny ruling will conclude the discussion the context circuit court’s G, legal principles admissibility testimo- Section III infra. The an a methodology. epidemiologist is a basis for to infer that [epidemiology sampling agent epidemiology Syl. pt. involves can cause a practice chemical disease.” systematic as to minimize matching King Burlington so v. Santa Fe Northern analysis to designed Co., and statistical Ry. bias Neb. N.W.2d (2009). effect of random errors estimate the “Assessing is whether an association theory is Epidemiology not a results. requires understanding of the causal an cancer, birth a causes or how substance study’s strengths and weaknesses of the de- defects, These disease. or autoimmune sign implementation, judg- as well as a disciplines. from other theories come study findings fit with ment about how knowledge.” D. al., other scientific Michael Faigman L. et Modern Scientific 4 David al., Epidemiol- Green et Guide on Expert Law and Science of Evidence: The Reference (2002). Manual Evi- 35-1.1, ogy, in Reference on Scientific Testimony § at 132 n.18 ed.2011). (3d Moreover, existing dence “[Epidemiological studies examine methodological epidemiologi- attempt if there soundness of an to populations to determine study resolving causation between a disease or condi- cal and its use is an association First, questions. causing require answering three suspected a tion and factor study or Dow Pharms. reveal an association between condition.” Merrell does disease (Tex.1997). Havner, Second, did agent 953 S.W.2d a chemical and disease? epidemiological study “association” any The issue of an errors in the an inaccurate cause fully Third, as follows: relationship has been more described result? is the between agent and the causal? [Tjhe the chemical disease epidemiology not intended field of See id. at 554. study group to to utilize the results any individual demonstrate causation for ex- determining whether an association Instead, per- plaintiff. studies are agent and suspected ists between a chemical to formed or undertaken first determine if disease, epidemiologist primarily rely upon statistically significant exists association (1) experimental types of stud- three studies: exposure and outcome. If between an an (2) studies, (3) ies, cohort case-control an and the such association revealed Fi- King, See 762 N.W.2d at 35. studies.8 of con- studies are determined be free nally, strength of an association between bias, error, founding, or other then an agent can a chemical and disease can be At this association established. risk, ratio, or be stated a relative odds epidemiologists interpret- point, others an attributable risk. “Each of these meas- ing epidemiologic can make an data degree urements association examines inference of a causal vis-á-vis existence which the disease when risk of increases relationship the lack thereof. exposed agent.” individuals are Green Woodside, Davis, C. III and Allison G. Frank al, supra, et at 566. To better understand Forgotten Hill Criteria: Bradford association, re- epidemiological we will Predicate, T. Jefferson L.Rev. 108 35 types these main view three of studies— (2013). studies, studies, experimental cohort clearly It should be understood that case control as well studies that studies as term is a term of art in “association” risk, examine association of relative odds “[tjhe epidemiology. It has been defined ratio, and attributable risk. degree dependence two statistical between Experimental experi- 1. studies. An re TMI or more events or variables.” In Cir.1999) study study in (3d mental has been defined as “a n. Litig., 193 710 F.3d omitted). population (internal planned which a is for a selected quotations and citation Moreover, regimen trial of a whose effects are meas- an association not the same as by re- comparing ured the outcome of the epidemiological An association causation. gime experimental group in the with the study may may not identified in a or be regimen control “Although epidemiological outcome another in a causal. al., causation, prove provide group.” Faigman supra, et at 184. they cannot do a types specialized 8. There are also additional studies. study by type goes several names participants. tus of the A may researcher trial, trial,

including, randomized clinical define study population a present in the experiment. supra, future, time Green et al. at 555. follow it into design study a population reti’ospeetively point at a in the question In order to answer the of whether past and follow it over historical time toward agent a chemical is related to a certain dis- present. situation, In either the re- ease, epidemiologist may conduct an ex- classify searcher study will population study perimental partici- in which selected groups into based on group one, pants randomly assigned are of two exposed members were agent the chemical groups: group exposed a to the chemical of interest. The task of a researcher in a agent group exposed. and a that was not retrospective population study is to deter- predetermined After a period, observation mine the people number of exposed participants groups in both are evaluated group interest, who developed the disease of development for the of the disease. An ex- sources, from all available reliable and com- perimental study is often used to evaluate pare that people number of with the number drugs new or medical treatments. Green et people group exposed. who were not al., supra, at 555. See also In re Bextra & respect prospective With to a study, the ex- Mktg. Celebrex Sales Practices & Prod. Liab. posed unexposed populations (N.D.Cal.2007) are fol- Litig., F.Supp.2d (wherein predetermined time, lowed for a length of study a clinical that revealed Cele- and the persons number of group each brex increased cardiovascular risk was relied develop who the disease of interest are com- upon the court to conclude plain- that the al., pared. supra, Green et at 557. experts’ testimony tiffs See also on causation was ad- al., missible); Faigman Co., supra, et McDarby at 162-65. v. Merck & N.J.Super. (Ct.App.Div. 949 A.2d 223 study A cohort advantage has the of allow- 2008).(explaining how clinical trials of Vioxx ing temporal relationship expo- between disease). revealed an association with heart sure and disease to be established more course, Of if agent’s a chemical effects are quickly study design. than in other As a harmful, knowingly a researcher cannot ex- of following study population result that is pose participants to the chemical. In situa- disease, initially affected the re- harmful, tions where agent the chemical searcher is able to determine the exact onset researcher will typically “observe” selected time of the expo- disease and its relation to participants already who have exposed been researcher, sure to the chemical. For a chemical, e.g., comparing already those temporal relationship “[t]his is critical to the exposed agent to an industrial chemical causation, question because must group participants another who have not precede if exposure disease onset caused the situation, exposed. been In this the re- al, supra, disease.” Green et at 558. compares searcher the rate of disease or 3. Case control studies. A ease control exposed death of group with that anof study selecting group involves of individu- al., unexposed group. supra, Green et (cases), als who have a disease of interest 555-56. choosing group a similar persons who study Cohort studies. A cohort has (controls). do not have the disease of interest “analytical been defined as an method of selected, groups When the the research- epidemiologic study in which subsets of a compare er will then past them terms of population defined can be identified who ... so, exposures. doing In the researcher been ... exposed have ... to a factor ... seeking expo- to determine whether a certain hypothesized probability to influence the sure that is associated with the disease re- given occurrence Faigman of a disease[.]” et higher in proportion past expo- sulted a al, swpra, A study at 183. cohort is also among among sure the “cases” than the prospective study called a followup “controls”. ... “[C]ase-eontrol studies are al., study. supra, Green et at 557. particularly study useful in the of rare dis- study eases,

A cohort study involves the study use of a if because a cohort were con- population ducted, regard without to the disease extremely large group sta- an would have al, general at 567. As a supra, Green et to observe the devel- in order

to be studied matter, interpreted as the relative risk is number of cases for opment of a sufficient follows: al., supra, at 559. See analysis.” et Green 1.0, equals the risk If the relative risk al., supra, at 166-69. Faigman et also 4 the same as the exposed in individuals is strength Relative risk. 4. unexposed in individuals. There is no risk a chemical exposure to between association exposure agent between association be stated as a relative agent can and disease and disease. de- concept of “relative risk” is risk. 1.0, greater If relative risk is than incidence rate of a ratio of the fined as the greater exposed in individuals is the risk population to exposed in an targeted disease unexposed individuals. than the risk in unexposed popula- in an incidence rate positive a association between There is of a Additionally, the “incidence rate tion. disease, exposure agent and the num- defined as the total targeted disease” is causal. which could be that manifests the disease ber of cases of 1.0,the If relative risk is less than period time during predetermined itself a less than the exposed risk in individuals is in of individuals divided the number unexposed in individuals. There is risk sum, inci- being population studied. association, reflect a negative which could the risk that an individ- dence rate illustrates agent protective or curative effect disease____ develop group will population ual in a risk of on predetermined time targeted disease within a al., supra, at 566-67. See also Green et al., supra, at period. Green et 566-67. Brown, as Mud —The Role Daniel J. Clear Assessing Epidemiological Data in Admissi- group that a com- example, For assume bility Rule Evidence under Delaware exposed to a posed of 100 individuals is (2012) (“The size 13 Del. L.Rev. agent, group composed of 200 chemical strength of that relative risk indicates exposed to the chemical. individuals is not example, a relative risk of For association. groups both After a researcher studies in ex- of disease those 3.5 means the risk 40 of the individu- year, one it is learned that is three and half posed to the substance targeted have exposed to the chemical als higher than the risk of disease those times disease, individuals who were and 20 of the exposed.”). who were not exposed the chemical are also found to ratio, like the ratio. The odds 5. Odds The relative risk of con- have the disease. risk, quantita- to illustrate relative is used tracting be determined as the disease would between tive terms the association follows: This tool agent and a disease. to a chemical easy way in the to estimate the incidence rate of disease is considered an study a rare per year when exposed 40 cases risk a ease-control individuals is investigation.9 The odds (40/100), is under disease per persons or 0.4. approximation of the risk permits ratio in the The incidence rate of disease study. the focus of the when a rare disease is per year unexposed individuals is 20 cases ratio, study, in a case-control The odds (20/200), per persons or 0.1. (one group that a case ratio of the odds disease) agent risk is calculated as exposed The relative was to a chemical (0.4) (one exposed group group without incidence rate in the that a control to the odds disease) exposed the same chemi- incidence rate in the unex divided However, study, the odds (0.1), in a cohort cal. posed group or 4.0. velop Without a rate or incidence the disease. noted that It has been disease, cannot calculate a a researcher be calculated for a relative risk cannot [a] study, relative risk. because a case-control case-control al., Epidemiology, study begins by examining group persons Green et Guide Reference aspect already That who have the disease. Evidence Manual on Scientific Reference study design prevents ed.2011). a from (3d the researcher n.58 determining de- the rate at which individuals proportion expressed as the ratio of the odds of able risk is the ratio is disease in to a exposed exposed population might by a disease when that developing be caused developing the dis- agent chemical to the odds of that might prevented by the and be exposed not to the chemical. ease when to eliminating exposure agent.” that Id. al., supra, at 568. Green et following example given has been example, a researcher conducts a case- For illustrate the determination of attributable study with a that has 100 individuals control risk: group, who act as the “case” and 100 disease example, if the For incidence rate in who act do not have the disease individuals unexposed group is ten and the incidence group. were the “control” It is found who exposed fifty rate in the is then the attrib- group of the 100 case individuals that 40 — = (i.e., percent 40; utable risk is 80 exposed agent, to a chemical and 60 50 10 were = 80%). group, This were not. the control 20 individu- would mean that 40/50 chemical, exposed percent to the and 80 exposed als were disease in the not. The calculation of the odds ratio group exposure were is attributable to the This, however, would as follows: suspect be substance. not stating percent same as that 80 (40/60) by exposure. disease is caused = - OR =2.67 Brown, supra, 13 Del. L.Rev. at 80. (20/80) Toxicological Methodology D. al., supra, at 569. Green et approximates an odds ratio [B]ecause experts, Another Petitioner’s risk, general the same rules of relative Goldstein, toxicologist. Dr. is a The record i.e., apply, interpretation an odds ratio of also one of shows that called 1.0 indicates that there is no association Green, CSX, is likewise a toxicologist. disease, exposure between and whereas an toxicology “[T]he science can under help positive ratio above 1.0 a odds indicates stand dose of a substance association an odds ratio below 1.0 following particular exposure achieved a has negative indicates association. any relationship toxicity or disease.” Brown, Eaton, supra, 13 Del. L.Rev. at 79. Judgment David L. Scientific Toxic Toxicology Torts —Primer epidemio- 6. Attributable risk. Another Judges Lawyers, Pol’y J.L. & logical measurement of risk is attribut- called (2003). Toxicology is a science focuses represents able risk. This measurement tool understanding and identifying the harmful the amount of disease that individuals agents.10 Toxicological effects of chemical may exposed be to such attributed purport provide alone do direct exposure. Attributable risk also can be for- evidence a was caused disease a chemical proportion as the mulated of the disease can, however, exposure. discipline exposed be among individuals that is linked to offering instrumental re scientific data exposure. risk re- “[T]he attributable garding contracting the increased risk of proportion flects the maximum disease upon dosage. disease D. that can be attributed to to an based Bernard Henifin, Mary agent consequently pro- Goldstein and Sue the maximum Reference portion Toxicology, potentially disease that could be Guide on in Reference Manual (3d prevented by blocking expo- on Scientific Evidence effect of 635-37 ed.2011). by eliminating exposure.” sure or Green toxicologists Courts have held that al., supra, differently, et provide 570. Stated if can on whether epidemiological agent association of the disease chemical caused a Bon disease. See Techs., agent causal, Inc., and chemical attribute “the ner v. ISP 259 F.3d 928-31 discipline toxicology primari- Expert Testimony 10. "The § is based The Law and Science of 35- ly upon chemistry biology." 1-1, (2002). sciences at 104 Faigman et Modem Scientific Evidence: al.. 628 debate, however, circular because it is Cir.2001); is

(8th v. Dow Chem. Loudermill (8th Cir.1988).11 experi- to potentially unethical and criminal Co., 569-70 868 F.2d by exposing them to haz- ment on humans designed and evalu- properly from “[D]ata Thus, agent. of a chemical ardous doses animals have experimental in ated studies toxicological provide studies the best animal reliable sources of to be and continue been concerning data readily accessible scientific potential identification for the information exposure. of disease from a chemical the risk and the estimation hazards human health Henifin, supra, and at 639.14 Goldstein L. populations.” Ronald exposed in risks toxicological Bucher, component A of a Determining central R. John Melnick and study dose-response involve relation- will Causality Experimental From Toxi- Disease ships. Faigman, supra, 4 at 107-08. That Studies, Pol’y 133 J.L. & cology 15 is, al, are conducted experiments with animals (2007). supra, et at Faigman See also relationship dose-response (“There overwhelming biological to determine is an agent by measuring how the of a chemical humans and other ani- similarity between mammals.”). different doses. Infor- mals, general response varies with particularly technique from this “is use- by toxicologists in- mation obtained used testing procedure toxic- understanding in the mechanisms of laboratory ful exposing animals12 volves to ity extrapolating data from animals agent, monitor- and to a chemical cells/tissues13 Henifin, supra, at changes humans.” Goldstein and comparing those ing changes, and making opinion about a a causation unexposed group. control 641. for an with those disease, toxicologist a a will course, ongoing chemical and is an debate as Of there person’s expo- the extent of a dose testing validly will consider animal the extent which Henifin, supra, at 638.15 and agent. to a chemical sure. Goldstein responses human reflect performed perimental on animals have summarized the science 11. One commentator potential health risks of been used to assess toxicology as follows: carcinogenic agents in work- toxic and our toxicology: basic tenets of There are three pre- general place and environment. The (1) potential have the to be harm- all chemicals based on dictive value of animal studies is (2) right dosage; many given chemical ful biological processes species in similarities agents signature pattern effects of toxic have major advan- of disease induction. Another causation; (3) that are used to establish tage animal studies is the elimination of laboratory responses in animals are useful high human need to wait for a incidence of determining potential effects on humans. cancers, years may which take as much as 30 identify Toxicology generally chemi- seeks to exposure time of first to clinical manifes- from populations pose threat to human cals that disease, public implementing before tation expo- a chemical risks associated with and the strategies. protective health epidemiology, given at a dose. Unlike sure Bucher, Determining Caus- Melnick and Disease causation, primarily to establish which seeks Studies, Experimental Toxicology ality From giv- toxicology primarily to estimate seeks (2007). Pol’y at 115-16 J.L. & exposure. potential en risks associated Johnson, Daunting: Is Too H. When Science Carl following explanation and illustra- 15.The is an Courts, Sensitivity, Multiple Federal Chemical tion of dose: Daubert, Spirit Envtl. L.J. Struggling 1 Vill. the 273, al., (2000). Faigman also 4 et 291-92 See a function of both concentration Dose is supra note at 107. century-old simpli- Haber’s rule is a duration. expression in which the fied of dose effects called in vivo research. 12. This is expo- of a concentration and duration effect agent (e.g., exposure to an sure is a constant This is called vitro research. parts per the same million for hour has exposure part per impact million for 10 reliability justification of animal stud- 14. The levels, hours). Exposure concentra- which potential on hu- effects of chemicals ies for tions, confused with dose. This can are often follows: mans has been stated as problematic attempting particularly when be implications to a understand the Why to evaluate are animal models used regulatory is explanation exceeds a standard that is level that risk? The most obvious human example, different time frame. For health set for a it unethical to test for adverse effects, cancer, drinking through water contaminant assume a in humans such as 100,- 1 in cancer. To avoid a exposures. known cause of Just as animal models intentional this contaminant 000 lifetime risk caused preclinical pharma- of new are used in trials water, humans, average assuming drinking that the testing agents ex- before ceutical

629 by toxicologists for these chemicals in breathed approach The taken air a harmful individual. assessing exposure step to chemical The second involves an evaluation, published agent has been summarized follows: based on the scienti- literature, fic exposures necessary to methodologies in- Exposure assessment produce the adverse effects associated with predicting clude mathematical models ex- may the chemicals to which individuals be source, posure resulting an emission from exposed. These two evaluations are then long might upwind; which be a distance step combined in the final the risk as- physical chemical or measurements of sessment provide to estimate of an air, food, water; media such as and and any proper- likelihood that harmful humans, biological within in- monitoring any ties of might or all of the chemicals cluding of blood and measurements urine expressed exposed have been in indi- exposure specimens. An assessment vidual. competing exposures. should also look for metrics, Schlumberger this continuum of Bombardiere v. Corp., Tech. 843, (N.D.W.Va.2013). body, greater F.Supp.2d the closer to the human 934 848-49 overlap toxicology. Toyota Corp., also Motor See Evans v. No. V-03-09, (S.D.Tex. 3454456, 2005 at *4 WL Henifin, supra, Goldstein and at 657. 9, Aug. 2005); Co., Prop. Roche v. Lincoln opinion toxicologist’s A on causation 744, (E.D.Va.2003); F.Supp.2d 278 754 Man upon preliminary should be based three as v. cuso Consolidated Edison Co. New sessments: (S.D.N.Y. York, Inc., 1437, F.Supp. 967 1445 First, analyze expert should 1997); Enter., Cavallo F.Supp. v. Star 892 the disease can be related to chemical ex- 756, (E.D.Va.1995), aff'd, part, 764 posure by biologically plausible theory. a rev’d, (4th part, Cir.1996); 100 F.3d 1150 Second, should examine wheth- Smith, Craig T. Peering Microscope: into the exposed plaintiff er the to the chemical was Gatekeeping The Rise Judicial Dau after absorption in a lead manner that can bert its on Federal Toxic Tort Effect Third, body. into should Litigation, & 13 B.U.J. Sei. Tech. L. 227 offer an about whether the dose to (2007); Neal Peter A. Valberg, C. Stout and exposed plaintiff which the is sufficient Law, Uncertainties, Bayes’ Sequential to cause the disease. Cases, Evidence Causation in Toxic Tort Henifin, supra, Goldstein and at 661. See (2005). U. 38 Mich. J.L. Reform 900 Eaton, 38-40; Pol’y & supra, also 12 J.L. Weight Methodology E. of the Evidence James, Toxicology Robert C. Role in Tox- Causation, Litigation: Establishing ic Tort experts, toxicologist One of the Petitioner’s (1994). 61 Def. Couns. J. Courts also Goldstein, during Dr. indicated his recognized “three-step methodology have weight upon he relied of the evi- for toxicologists endorsed the World rendering methodology opin- his dence Burton, Organization[.]” Young Health ‘weight “[T]he ion.16 term evidence’ is (D.D.C.2008). F.Supp.2d The process used characterize a method in methodology risk has assessment been de- all which scientific evidence is relevant scribed as follows: hypothesis status of a causal is taken

First, Krimsky, Weight is made of into account.” Sheldon evaluation the chem- Law, might Policy icals to which the individual have Evidence in of Scientific (2005). exposed, been and of the of Am. J. Pub. Health S129 Under this concentrations Henifin, person approximately will drink 2000 mL of Goldstein and Guide on Toxi- Reference lifetime, daily regulatory cology, water au- Evi- Manual Reference Scientific (3d ed.2011). thority dence sets the allowable contaminant stan- 638 n.12 (xg/L. drinking Drinking dard in water at 10 glass containing jxg/L previously expert, one contaminant, It was that CSX’s of water of this indicated Green, However, standard, exceeding although toxicologist. is a her testi- achieving "reasonably mony rambling does not was far come close to too acrimonious medically clearly methodology probable” precise cause of an individual understand what she case of cancer. used. omitted)).17 weight tions and citations all available “expert considers approach, by regula- weight methodology to be af- is used the evidence and determines strengths basis of the on the the Environmental tory agencies forded to each such as studies.” the individual Occupational and weaknesses Agency18 and the Protection Sidney Shapiro, A. McGarity and O. Thomas “Regula- Administration. Safety and Health Rulemaking and Regulatory Science in analysis panels use tory agencies [the or risk Weight Evidence Unifying the Tort: to assess the weight method] of evidence 65, Pol’y Forest J.L. & Approach, 3 Wake that a of the scientific evidence total value (2013). may dangerous to human be substance the evidence” is phrase “weight of The also Krimsky, supra, at S139. See health.” meanings by scien- different accorded (“[G]overnment often King, 762 N.W.2d at 39-40 court: explained As one tists. weight-of- use a agencies and some weight [WOE] method of evidence methodology. That methodolo- the-evidenee in a literature either is used in medical analyzes data from comprehensively gy metaphorical sense. rigorous scientific or fields, animal primarily different scientific methodology where WOE It is used studies, to assess epidemiological tests meth- interpretative points to established risks.”). commenting upon carcinogenic review, (e.g., systematic narrative odologies methodology, Jus- weight of the evidence criteria, meta-analysis, quali- causal and/or following: tice Stevens noted studies)---- toxicological ty for criteria Appeals expressly decided Court of [T]he is, if of the term metaphorical use methodolo- “weight of the evidence” else, say body way to nothing a colorful scientifically To acceptable. gy was judged have examined and of evidence we extent, opinion is Appeals’ the Court of we have not described but using a method intrinsically from a “unscien- persuasive. or less inferred It is not could be more reading of our ar- experienced professionals careful between-the-lines tific” for paper. by weighing all avail- rive at a conclusion is not the scientific evidence—this Am., LLC, able Reeps v. BMW N. Reeps ex rel. “junk with which Daubert 2362566, sort of science” 100725/08, at *3 No. 2013 WL 2013) (internal 10, quota- was concerned. May (N.Y.Sup.Ct. Carcinogen "Guidelines for ways weight In the EPA's 2005 in which of the

17. The different type of data may been it described the be used scientists have Risk Assessment” evidence weight as follows: would be considered its summarized methodology: evidence contempo- uses in WOE has several distinct First, practice. rary it most often scientific Weight Narrative of Evidence 1.3.3. sense, metaphorical pointing appears to a in a impor- guidelines emphasize the The cancer body reference to of scientific evidence without weighing in reach- all of the evidence tance of Second, methodology.... any specific in some carcinogenic ing conclusions about the human situations, specifically approach refers a WOE accomplished agents. in a potential of This is technique evi- in which "all available to a integrative step assessing single after all of interpret- be examined and dence” should Evidence con- lines of evidence.... individual ed____Third, di- a WOE method refers often findings, or lack there- includes tumor sidered method, synthetic rectly such as to some other animals; of, laboratory in humans review, meta-analysis, systematic narrative physical properties; agent's its chemical and so-called “causal criteria" associated or the (SARs) relationships structure-activity as com- discipline public with the health most often carcinogenic agents; pared with other Fourth, may epidemiology. a WOE method carcinogenic pro- addressing potential approach synthe- point to an institutional action, mode(s) either in vivo or cesses and sis____ Finally, relatively rare instances epidemiologic studies are in vitro. Data from assessment, approach WOE in- health-risk characterizing generally preferred human for assigns numerical a method that volves weights hazard and risk. cancer cre- individual scientific studies and Agency, Guide- Environmental Protection U.S. using summary assessments ates numeric Carcinogen 1-11 Risk Assessment lines for algorithms. mathematical (2005), http://www.epa.gov/ttn/atw/cancer- Weed, Synthesis Douglas General L. Evidence (last Nov. guidelines-final-3-25-05.pdf visited on Key Methods and an Assessment Causation: 8, 2013). (2006). Reliability, 54 Drake L.Rev. (2013) (“Both Joiner, regula- 522 U.S. common law courts and Elec. Co. v. General 522-23, tory agencies 139 L.Ed.2d 118 S.Ct. should consider (1997) (Stevens, J., weight concurring, part, based of the evidence evaluations the available dissenting, part). scientific information in ac- criteria, cordance with valid scientific such as Acuity Specialty The court in Milward criteria, Bradford Hill evaluating for evi- (1st Inc., Group, F.3d 11 Cir. Products dence.”); Kimberly Gordy, The Cancer 9/11 2011), weight explained evidence Law, Policy, Conundrum: The & Politics of methodology as follows: Act, Zadroga Legis. 37 Seton Hall J. “weight approach of the evidence” (“The (2012) provides court ... Milward making causal determinations involves a guidance weighing useful evidence.... It logical reasoning often mode of described the “weight endorsed of the ap- evidence’ explanation,” as “inference to the best in proach, encompasses which the Bradford Hill guaranteed by which the conclusion is not methodology.”). premises____ to the best [Inference explanation thought involving can be of as Methodology F. Bradford Hill general steps, may six some which be experts, Petitioner’s Dr. Durie and Dr. (1) implicit. identify The must scientist Infante, upon relied Bradford Hill meth- association between an and a dis- odology in rendering opinions. their The (2) ease, range plausible consider ex- CSX, also record showed that for association, (3) planations rank for the Shield, upon relied the Bradford Hill according explanations plausi- rival to their Methodology. methodology involves the (4) bility, sepa- evidence to seek additional by epidemiologist use of criteria set out Sir plausible plau- rate the from the less more Austin publish- Bradford Hill in an article he (5) explanations, sible consider all of the Hill, in ed 1965. See Sir Austin Bradford (6) evidence, relevant and available inte- The Environment and Disease: Association grate using professional judg- the evidence Causation?, Royal Soc’y 58 Proc. Med. ment to come a conclusion about the (1965). criteria, 295 The Hill Bradford as explanation. best called,19 they are are relevant “considered determining epidemiologically- whether an judgment The fact that the in the role potential observed correlation between a weight approach of the is evidence more agent causal and a can or cannot disease readily it apparent than is other meth- legitimately be treated as cause rather than odologies approach that the does not mean merely an Jennifer as association.” L. any is less scientific. No matter what Mnookin, Atomism, Holism, and the Judi- used, methodology an evaluation of data Evidence, Assessment 60 UCLA cial scientific evidence determine wheth- 1524, (2013). differently, L.Rev. 1524 Stated appropriate er an inference of causation is Bradford Hill are criteria factors that are requires judgment interpretation. considered when a researcher seeks to deter- weight judgment use of epidemiological mine whether an observed methodology evidence is similar to that in and a association between a disease chemical diagnosis, differential which we have re- agent City is causal. v. New Nonnon peatedly found to be a reliable method of York, 88 N.Y.S.2d A.D.3d 932 433 diagnosis. medical (2011). States, See also Gannon United (internal Milward, (E.D.Pa.2007) (“Oth- quota- F.Supp.2d 639 F.3d at 17-18 omitted). preeminent See Thom- have tions citations also er scientists relied on and McGarity Sidney Shapiro, Regu- adapted O. A. as the Bradford Hill criteria to deter- latory Rulemaking be Science in and Tort: mine whether a virus can deemed to cause cancer.”). “[Cjourts Unifying Weight Ap- the Evidence human that have consid- proach, Pol’y question J.L. & held Wake Forest 97 ered the have it is not factors, (D.NJ.2002) ("These They as the also known Bradford Hill first set forth Sir Hill, viewpoints. Magistrini See v. One Hour Austin have been Bradford also referred to Martiniz- ing Dry F.Supp.2d Viewpoints!.]"). Cleaning, 180 592 n. 9 gener- a more modern and more epidemiologist to To take methodology for an proper re- example upon which I have now al factors without data Hill apply the Bradford years, prospective fifteen flected for over showing an associa controlled from that the inquiries smoking into have shown Litig., Prods. Liab. In re Fosamax tion.” lung ciga- death rate from cancer of the (S.D.N.Y.2009). 164, 188 F.Supp.2d to ten the rate rette smokers is nine times Hill criteria include: Bradford heavy ciga- and the rate in in non-smokers (2) association, (1) consistency strength of the twenty thirty times as rette smokers (3) association, specificity of the associ the other hand the death rate great. On (4) ation, relationship the associ temporal coronary is no from thrombosis smokers (5) ation, dose-response gradient or biological less, twice, possibly the death more than (6) association, plausibility of the curve of the good Though in nonsmokers. there is rate (7) causation, explanation, coherence of the surely it is support causation evidence (9) (8) data, existence of experimental think of some much easier in this case to Hill, supra, relationships. analogous causal may go hand-in-hand features of life that Royal Soc’y Med. at 295-99. See also 58 Proc. might smoking con- —features Cos., Inc., F.Supp.2d v. Dillon Watson or, underlying cause ceivably be the real (D.Colo.2011); Dow Merrell 1150 contributor, least, wheth- important Havner, Pharms., Inc. v. 953 S.W.2d exercise, nature of diet or er it be lack of (Tex.1997).20 718-19 explain pro- factors. But other any lung nounced excess cancer exhaus- Hill criteria are “not The Bradford requires terms some other environmental type of evidence must be tive and that no one intimately linked with feature of life so causality may be inferred.” present before cigarette smoking and with the amount Milward, In re F.3d at 17. See also be smoking that such a feature should (Del.Su- 120,134-35 Litig., 900 A.2d Asbestos easily detectable. (“None stand per.Ct.2006) of these criteria alone; important consider- they are all when Hill, Royal Soc’y supra, 58 Proc. Med. risk.”). ing the issues of association King, 762 at 40 295-96. See also N.W.2d is, may the factors be That “one or more of strength, (“[Regarding an association’s relationship a causal ex- risk, absent even where greater the like- higher the relative Martinizing Magistrini v. One Hour ists[.]” relationship is causal. Yet low- lihood that a n. 9 Cleaning, F.Supp.2d Dry causality.”). can reflect relative risks er (D.N.J.2002).21 each of the Comments on Consistency the association. The 2. follow. Bradford Hill criteria consistency criterion seeks to of association may whether a similar association determine Strength Showing of association. variety of different situations. be found between a strong association exists Showing of an associ- numerous observations likely agent and a disease is more chemical ation, people in situa- with different diverse is, relationship. That indicative of a causal tools, will tions with different measurement stronger relationship between the credibility find- of an association increase disease, like- agent and the the less chemical commentary following ing. provided Hill ly relationship is due to chance it is that the on this factor: (a confounder). an extraneous variable or may special be of im- requirement following example of this provided Hill singled rare hazards out portance for those criterion: up strength, help methodology is to us to make our "weight er or less of the evidence” 20. The along question crite- there with the Bradford Hill the fundamental can be used minds on —is Milward, F.3d at 17. way explaining ria. See any the set of facts other us, any equally, or is there other answer before Hill, point emphasized who also was 21. This more, likely and effect? than cause cautioned in his article: Hill, Bradford The Environment Sir Austin bring my viewpoints nine can indis- None of Causation?, 58 Proc. Disease: Association or against putable the cause and evidence for or (1965). Soc’y Royal Med. hypothesis required and none can be effect do, they great- qua non. What can a sine many in the Section’s terms of reference. With non-smokers from causes of death. many industry surely alert minds at work in to- But here one must my return to characteristic, many day an environmental association first strength of the as- may up. be thrown Some of them on the sociation. If other causes of death are significance customary tests of statistical raised 20 or even 50% in smokers unlikely appear will to be to be due to whereas lung cancer of the is raised 900- 1,000% chance. Nevertheless whether chance is specificity specificity we have —a explanation magnitude or whether a true hazard of the association. may has been revealed sometimes be an- keep We must also in mind that diseases only by repetition swered of the circum- may have more than one cause. It has stances and the observations. always possible acquire been a cancer of general

Returning my example, more sweeping chimneys scrotum without Advisory Surgeon- Committee to the taking mulespinning in Lancashire. General of the United States Public Health One-to-one relationships frequent. are not smoking Service found the association of I Indeed believe that multicausation is lung retrospective with cancer of the in 29 generally likely single more than causation prospective inquiries. and 7 The lesson though possibly if we knew all the answers broadly here is that the same answer has might get single we back to a factor. quite variety been reached in a wide short, specificity if may exists we be techniques. situations and In other words able to draw conclusions without hesi- justifiably we can infer that the association tation; if it apparent, is not we are not fallacy is not due to some constant error or thereby necessarily sitting irresolutely left permeates every inquiry. And we on the fence. guard against have indeed to be on our Hill, supra, Royal Soc’y 58 Proc. Med. at 297. that. Davis, See also supra, Woodside 35 T. Hill, supra, Royal Soc’y 58 Proc. Med. at 296. (“The Jefferson L.Rev. at 116 crux of the Woodside, See also Prank C. III and Allison specificity consideration is that causation is Davis, G. The Hill Criteria: The likely very Bradford if specific population specif- aat Predicate, Forgotten 85 T. Jefferson L.Rev. develops ic site likely a disease with no other (2013) (“Reduced elementary to an explanation. specifically, More per- well level, consistency demonstrates that the re- demonstrating formed studies an association particular study sults of a are not outlier specific between exposure clearly and a Consistency result. indicates that the re- defined disease or condition—otherwise generally sults are concurrent with the re- known as the case definition —are more they sults of other gen- studies —not that inferring value in the existence of a causal erally accepted.”). relationship poorly than studies with defined Specificity exposures loosely 3. of the association. The defined diseases or and/or conditions.”). effect, specificity factor seeks to show that an cancer, e.g., cause, lung only has one smok- Temporal relationship 4. of the associa- ing. Hill discussed this factor as follows: tion. This factor seeks to assure that the If, here, the association is limited to exposure agent preceded to a chemical specific particular workers and to sites and time, i.e., disease a reasonable amount of types of disease and there is no association precede a cause must an effect in time. Hill between the dy- work and other modes of briefly commented on this factor as follows: ing, clearly strong argument then ais My temporal fourth characteristic is the in favour of causation. relationship of the association—which is

the cart and which the horse? This is a Coming prospective question to modern times the might particularly which be rele- investigations smoking and cancer of the vant development. with diseases of slow lung have been criticized for showing particular Does a diet lead to disease or do specificity other words the early stages death rate of the disease lead to —in higher of smokers is than the peculiar death rate of those dietetic par- habits? Does a of the envi- factory quantitative measure occupational environ- occupation or

tieular explore permit us to the tubercle ronment which will promote infection ment invari- dose-response. who But we should men and women or are the bacillus ably it. of work more liable seek that kind select whatever the envi- contract tuberculosis Hill, Royal Soc’y Med. at 298. supra, 58 Proc. indeed, already or, they have ronment — (“A King, at 40 dose- See also 762 N.W.2d temporal problem may it? contracted relationship primarily a hallmark response certainly needs to be but it not arise often higher exposures to the toxicology. If remembered, with selective particularly disease, the agent the incidence of increase industry. at work factors strongly suggests a causal relation evidence Soe’y Hill, Royal Med. at 298. Proe. supra, ship.”). Davis, supra, T. See also Woodside Plausibilitg of the causation. Show- (“Not only must the at 119 L.Rev. Jefferson ing an association is causal is easier development of the exposure precede support such a biological when or other facts period of time alleged symptoms, but However, is not such evidence conclusion. exposure and the onset alleged between tersely commented on this essential. Hill compensation is symptoms for which factor as follows: with the known sought must be consistent helpful if causation we It will be question. latency period for the biologically plausible. But this suspect is period of time latency period is the we cannot a feature I am convinced agent and manifesta- exposure to an

between biologically plausible de- demand. isWhat symptoms.”). disease tion of knowledge of the pends upon biological dose-response 5.Biological gradient or day. biological curve of the association. Hill, Royal Soc’yMed. at 298. supra, 58 Proc. determine gradient seeks to show or factor (“When King, at 41-42 762 N.W.2d See also chemical exposure to a whether increased develops, how a disease know of the disease. agent the incidence increases biological consisten should show association as follows: Hill addressed this factor cy knowledge____An expert’s ina with that is one which can re- the association [I]f pro bility explain pathology a disease’s dose-response biological gradient, or veal a evidence, goes weight gression curve, carefully look most then we should admissibility.”). not to its instance, the fact evidence. For for such explanation. The 7. Coherence of lung cancer of the that the death rate from viability enhanced when it of an association is cigarettes linearly with the number of rises with what is known about does not conflict very great deal to the daily, adds a smoked variables, competing study and when cigarette smokers simpler evidence that not exist. plausible hypotheses theories or do higher rate than non- have a death words, should be In other an association comparison would be smokers. That knowledge. with relevant other coherent weakened, necessarily though not de- factor as follows: Hill commented on this upon, say, a heavier stroyed, depended if it interpretation of our eause-and effect [T]he light in and a lower death rate smokers seriously with the conflict data should should then rate in heavier smokers. We generally facts of the natural histo- known envisage complex much more need to some ry biology the disease —in the ex- relationship satisfy cause-and-effect to Advisory pression of the Committee to hypothesis. dose-response curve The clear have coherence. Surgeon-General it should explanation obvi- simple admits of a ously puts light. in a clearer the case lung cancer the Thus in the discussion ciga- clearly finds its association be true of an Committee same would temporal industry. smoking coherent with the alleged dust hazard in The dust- rette varia- place in the two greater the inci- rise that has taken ier the environment the generation and with the over the last expect dence of we would to see. bles disease mortality difficulty satis- sex difference Often the is to secure some —features apply occupational prob- in an might well whether an accepted phenomenon in one area lung lem. The known ratio of applied can be tersely to another Hill urban/rural area. mortality cancer does not detract from co- commented on this issue as follows: herence, nor the restriction of the effect to In some circumstances it would be fair lung. judge by analogy. With the effects of Hill, supra, Royal Soe’y 58 Proc. atMed. 298. thalidomide and rubella before us we Davis, supra, See also Woodside and 35 T. surely ready would accept slighter be (“The Jefferson L.Rev. at 123 difference be- but similar evidence with drug another or seem, plausibility tween coherence and would another pregnancy. viral disease in in part, plausi- to be one of semantics. While Hill, supra, Royal Soe’y 58 Proc. Med. at 299. (an bility positively is worded association Davis, See also Woodside and supra, 35 T. should be in line with substantive knowl- (“Recent Jefferson L.Rev. at 125 case law (an edge), presented negatively coherence is upon has cast caution the extent to which seriously association should not conflict with analogy may evidence of be considered in knowledge). substantive Consideration of developing opinions on causation. Courts reject coherence would an observed result as have warned that a reliable methodology predominant non-causal if it contradicted a must still be utilized in drawing analogies.”). theory; plausibility while leaves the re- regarding particu- searcher more room which Qualifícation, G. Methodology piece lar knowledge of substantive to evalu- Opinion Expert against.”). ate the results Witnesses Experimental data. An association mentioned, previously As expert the three by any can be enhanced related research that witnesses who testified for the Petitioner at experiments. is based on Hill said the fol- evidentiary hearing Infante, were Dr. Dr. lowing about this factor: Goldstein and Dr. Durie. CSX called Dr. Occasionally possible it is appeal Shields and Dr. Green as witnesses. experimental, semi-experimental, evi- In this section we will summarize each ex- example, dence. For because of an ob- pert’s qualifications, methodology opin- preventive served association some action ion. is taken. prevent? Does it fact reduced, qualifications, 1. Dr. workshop dust Infante’s lubricat- method- ology opinion. ing changed, persons oils are stop smoking Infante was called cigarettes. frequency as an witness Is the of the associ- Petitioner. Dr. In- fante public ated events affected? received a Ph.D. in strongest Here the health from support Department hypothesis may Epidemiology for the causation University Michigan be revealed. Dr. In- 1973.22 published fante has approximately peer Hill, supra, Royal Soc’y 58 Proc. atMed. journals, reviewed articles in scientific Davis, 298-99. See also Woodside and su- majority epidemiology of which involve cau- (“From pra, 35 T. Jefferson L.Rev. at 124 sation. expertise Dr. Infante’s area of standpoint, scientific it is unfortunate that occupational epidemiology. environmental type generally this evidence not avail- agent’s able. When an suspected effects are Dr. Infante worked as a research harmful, to be knowingly researchers cannot University Michigan associate at the and expose people agent. It is difficult to epidemiologic as an consultant for the World design types these of studies due to the Organization Washington, Health D.C. Dr. implications experimentation ethical on hu- employed Infante was epidemiologist as an mans.”). Department for the Ohio of Health from analogous 9. Existence of 1975-1978, causal rela- During period 1974-1975. tionships. This factor seeks to determine Dr. epidemiologist Infante worked as an for 22. Dr. degree University Infante also received a D.D.S. in 1966. College Dentistry from the at the Ohio State myeloma, and multiple and diesel exhaust Occupational for Safe- Institute

the National (“NIOSH”), Mr. Harris’ diesel exhaust caused Center Dis- ty Health and upon Cincinnati, myeloma. Dr. Infante relied multiple Control, Ohio. While ease conjunc- methodology in epidemiological NIOSH, performed Infante Dr. working for the Bradford Hill criteria. tion with who were of workers epidemiological studies included that to chemical substances exposed litera- epidemiology Dr. Infante reviewed benezene, vinyl chloride. pesticides and involving worker diesel exhaust ture railroad 1978-2002, Infante worked for Dr. From myeloma; animal can- multiple and Safety Health Administra- and Occupational expo- exhaust related to diesel cer studies (“OSHA”), Department of United States tion sures; exhaust on DNA the effects of diesel Labor, Washington, D.C. While die- lymphocytes; components of and human OSHA, employed as the Dr. Infante an elevated risk that demonstrate sel exhaust Carcinogen Identifi- Office of Director of the involving ex- myeloma; and data multiple (“OCIC”) for five and Classification cation components of diesel exhaust: posure to two Director of the Office of years and as the pristane and benzene. (“OSR”) for nineteen Review Standards study reviewing a Infante testified to work at OCIC included years. Dr. Infante’s al., Meta-Analysis et by Dr. Tomoko Sonoda had workplace substances that identifying Expo Multiple Myeloma and Benzene of sure, classifying and ability to cause cancer (2001),23 Epidemiol. which 11 J. at OSR involved Dr. Infante’s work them. be significant association demonstrated workplace exposure to harmful evaluating myeloma. engine multiple tween exhaust expo- developing occupational substances International testified that Dr. Infante causing were for substances that sure limits Tech on Cancer issued Agency for Research research work workplace. in the cancer Number 42 in nical Publication for toxic work- developing standards involved ex publication that diesel stated asbestos, ar- included place substances that multiple exposures have been linked to haust cadmium, senic, benzene, ethylene oxide and Dr. Infante further myeloma and leukemia. 2002-2011, formaldehyde. From Dr. Infante edition of a treatise that in the third testified at the adjunct professor and lecturer was an Joseph F. Frau by David Schottenfeld Service, and Health of Public Health School Jr., meni, Preven Epidemiology and Cancer University. George Mason tion, show an reported it was ele diesel exhaust and association between Dr. Infante has been During his career myeloma. multiple vated risk of advisor for the World Health consultant or Institute of Environ- Organization, National report prepared Dr. Infante for the Sciences, Department mental Health opin- for his Petitioner summarized the bases Services, Safety National Health and Human ion as follows: Sciences, Council, Academy Na- National have Cohort and case-control studies Institute, Federal Asbestos tional Cancer exposed to die- demonstrated that workers Taskforce, the American Public Health (DE) significantly ele- have a sel exhaust in the Dr. Infante is a Fellow Association. myelo- [multiple vated risk of death from College Epidemiology. American Epidemiological studies have also MM. ma] B- damage to demonstrated chromosomal litigation Dr. Infante was retained exposed diesel lymphocytes of workers epidemiological to render line, Another cancer of the B-cell exhaust. there was an association between conducting any "Meta-analyses "meta-analysis” do not involve as fol- 23. Dr. Infante defined lows; highly experiments, are nevertheless re- new but community you garded for their abili- analysis analysis in the scientific where A [meta] studies, large pull ty synthesize of data and the data from a number of amount data, you you and then evaluate general particular combine the consensus in a illustrate a you Lawson, then select to determine the studies that 352 Or. 291 P.3d field.” State v. not there’s an elevated risk of—of whether or (2012). 700 n. 12 you’re interested in evalu- the associations that ating. leukemia, lymphatic provides chronic also demon- tion biological plausibility to the epidemiological significant expo- strated a association with observations related to die- Furthermore, sel exhaust and risk of developing sure to diesel exhaust. ben- MM. zene, DE, component of also has been Ultimately, opined Dr. Infante that there significantly associated with an elevated significant is a association between diesel MM, developing pristane, risk of exhaust and the multiple myeloma risk of DE, component additional has demon- and, that “Mr. occupational exposure Harris’ plasmacytomas strated the induction of in to [diesel exhaust] between 1978 and 2007 experimental animals. These latter tu- significant were [sic] contributing factors and are similar to human mors MM. likely the most cause development of his [multiple myeloma].”24

The association between diesel exhaust exposure and MM has in been derived qualifications, 2. Dr. Goldstein’s meth- ability face of several factors that limit the odology opinion. Dr. Goldstein was through epi- to detect such an association called as an by witness Petitioner. demiological study. The difficulties in Dr. Goldstein biology received a Ph.D. in in identifying an epi- association with MM in University York, 1962 from the State of New demiological study are a reflection of sev- at Buffalo. Dr. Goldstein published has eral spite factors----In of the ... limita- roughly peer reviewed in articles scientific tions, several cohort studies of workers journals. Dr. Goldstein’s area of expertise is exposed to diesel exhaust now demonstrate toxicology, specifically animal respect MM____ elevated risks of death from polycyclic hydrocarbons.25 aromatic Case-control studies which allow for the From 1972 to Dr. Goldstein worked larger recruitment of much cases of MM California, University at the at San Fran- can be in identified cohort studies also cisco, in capacities,, including various associ- large have been A conducted. number of professor ate in Department Radiology these significant studies demonstrate a as- Oncology. From 1989 to Dr. Goldstein sociation between to diesel ex- employed as a researcher Electric haust and MM. (“EPRI”), Power Research Institute Palo Diesel exhaust also has been demon- Alto, EPRI, California. While Dr. Gold- strated damage lym- to cause DNA stein supervised conducted and in- research addition, phocytes exposed workers. In volving toxicological hazards caused experimental studies demonstrate that die- polycyclic hydrocarbons aromatic that are components sel exhaust and ex- diesel found in coal tars.26 The World Health Or- haust, e.g., polycyclic hydrocar- aromatic ganization employed Dr. Goldstein 2002 to bons, mutagenic experimental are test compare evaluate and radiation hazards asso- systems, experimental and cause cancer phone ciated with cell use with that of carcin- animals. Diesel exhaust itself as well as ogenic hazards associated with coal tars. components additional of diesel exhaust the federal Environmental Protection experimental are known to cause cancer in Agency part hired Dr. Goldstein to be of a animals, including lymphoma, and addition- group charged responsibili- that was with the components al DEof also ty demonstrate the revising approach used to evaluate experimental induction of cancer in polycyclic ani- hydrocarbon aromatic hazard mals, including lymphomas. This by complex informa- caused mixtures such as coals. During testimony, 24. cy his Registry, Infante acknowl- for Toxic Substances and Disease edged that he reviewed literature that did not http://www.atsdr.cdc.gov/substances/toxsubstance. support opinion. his (last 8, 2013). asp?toxid=25 visited Nov. (PAHs) "Polycyclic hydrocarbons aromatic polycyclic 26.Dr. Goldstein testified that aromat- group are a of over 100 different chemicals that hydrocarbons ic found diesel exhaust as during incomplete burning are formed well as coal tar. He also testified "[c]hemi- coal, gas, garbage, organic oil and or other sub- same, cally they are the but their distribution and stances like tobacco or charbroiled meat. PAHs concentration within the two sources would usually containing are found as a mixture two or vary.” compounds, Agen- more of these such as soot.” litigation reviewing After literature in- in this sel exhaust. was retained

Dr. Goldstein po- diesel opinion volving as to whether and the effects of to render an animal studies multiple myeloma. Dr. Gold- lycyclic hydrocarbons, exhaust caused Dr. Goldstein aromatic weight upon he relied testified that stein polycyclic hydrocarbon, aromatic found that methodology to render his of the evidence lungs ingested through the and carried opinion. bloodstream, into through the can travel impact forming or- bone marrow and blood literature from reviewed Dr. Goldstein responsible develop- for the gans that are agencies that and international governmental words, multiple myeloma. diesel ex- In other of whether ment of addressed the issue litera- general. opined polycyclic caused cancer that aromatic haust Dr. Goldstein from the Environ- publications multiple myeloma.29 ture included hydrocarbons caused Agency,27 International Protection mental analysis report set out an Dr. Goldstein’s Cancer,28 National on Agency for Research degree to which Mr. Harris was ex- Health, Occupational Science Institute of exhaust;30 posed to diesel Program of the National Toxicology National Science, Mr. evaluating posed Health In the risk Har of Environmental Institutes of Certified by and the American Conference work environ ris diesel exhaust his upon Based his re- Hygienists. Industrial important get idea of ment it is some on the analysis of the literature view Unfortunately contempora no the dose. subject, opined that diesel ex- Dr. Goldstein contaminants neous measures relevant general. haust can cause cancer diagno in the time before his were made attempt will to do sis.... What I therefore exhaust determining diesel by put perspective ratio into is the dose myeloma, multiple Dr. Goldstein fo- caused (including using available data anecdotal polycyclic aromatic cused his research on the evidence) guidelines for diesel are found in die- as well as hydrocarbon chemicals that study reported published report 28. Dr. Goldstein data from a 1988 concluded the fol- 27.The EPA’s IARC, lowing: "probably which found diesel exhaust 2A).” appears carcinogenic (Group It to humans Weight-of-Evidence Characterization H.A.I. report that after 2011, Goldstein’s Using Guide- U.S. EPA’s revised draft 1999 12, study IARC released a new on June Carcinogen Risk Assessment lines for engine which "classified diesel exhaust as (DE) (U.S.EPA, 1999), likely diesel exhaust 1), (Group carcinogenic to humans based carcinogenic by inhalation to be to humans exposure evidence that is associated sufficient exposures. environmental The basis for from lung cancer.” Inter- with an increased risk following this conclusion includes the lines of Cancer, Agency World national for Research on evidence: Engine Org., Exhaust Car- Health IARC: Diesel strong evidence but less than sufficient http:llwww.iarc.fr/enlmedia-centrelprl cinogenic, exposure between DE for a causal association (last pdfs/pt-213-E.pdf on Nov. visited 2012/ 2013). lung among cancer risk workers and increased occupations exposure in varied where to DE occurs: study he 29. Dr. Goldstein made clear that no that including supporting extensive data definitively polycyclic aro- reviewed stated that mutagenic chromosomal demonstrated and/or hydrocarbons multiple myeloma. constituents, caused matic organic effects of DE and its upon weight His was based knowledge mutagenic car of the known and/or evidence. cinogenic activity of a number of individual particles organic compounds that adhere to present gases; DE and are in the have 30. Courts carcinogenicity DPM and evidence of recognized general- in toxic cases it is tort organic compounds in rats and the associated ly impossible quantify plain- difficult or (dermal, exposure in mice other routes of [Therefore], exposure toxin[.] [i]t to a tiff’s tratracheal, intraperito and subcutaneous and always necessary plaintiff quantify for a injection); neal precisely the dose-re- levels or use suggestive for the bioavailabil evidence sponse relationship, provided whatever ity organic compounds DE from DE in hu causation methods an uses to establish mans and animals. generally accepted (CASRNN.A.) in the scientific commu- Engine Integrated Diesel Exhaust nity. http:// Syst., Agency, Risk Info. U.S. Envtl. Prot. York, (last City Nonnon v. New 88 A.D.3d epa.gov/IRIS/subst/0642.htm visited Nov. (2011). 2013). N.Y.S.2d 436-37 proposed by standing Confer the the American of conditions under Mr. exhaust which for a Hygienists years. Governmental for ence of Harris worked limit for of Threshold Value diesel exhaust qualifications, 3. Dr. Durie’s methodol- (Time Average). Weighted It 0.15mg/m3 ogy opinion. and Dr. Durie was as called provide perspective to is intended by witness Petitioner. Dr. Durie a full dragging when train was conditions degree received a medical in 1966 the from uphill in an tunnel. load unvented University School, Edinburgh of Medical Ed- that the For this calculation I assume inburgh, Scotland. Dr. published Durie has hp on Mr. engines Harris’ run were peer approximately 400 reviewed articles 0.6g the of and met exhaust standards journals, majority scientific the in- of which hydrocar l.Og matter and particulate total myeloma. multiple recog- volve He has been (PAH) per bhp-hr engines bons for diesel the top multiple nized as one of ten myeloma (63 manufactured between 1973 and researchers in the world. Dr. Durie is board 1998). 18997-19084, Apr. CFR Thus medicine, certified in internal hematology taking in the 10-20 each locomotive consist oncology. and pass longer through minutes to one of the Allegheny 1972-1992, on the River tunnels and New From Dr. Durie was on produced 300-600g routes would have faculty University at College of Arizona particulate Using matter. Stretcher’s faculty Dr. Medicine. Durie was on example, this Neck for the tunnel 1588 Charing Cross Westminster Medical x long feet and the bore is 21' 25 feet School, University London, from 1989- (estimated tunnel), photos from present, 1992. From 1993 to the Dr. Durie yards. has a tunnel volume of 30878 cubic has been Director of Hematologic Re- roughly exposure For a 10-20 minute Myeloma Programs search and at Cedars- trainmen would have been in an environ Comprehensive Sinai Cancer Center at 9.7-19.5mg/yd3 particulate ment of mat California, University Angeles Los ter, though engine concentration (“UCLA”). career, During his has Durie likely put cab would be less. this in To spent roughly thirty years laboratory doing (subse perspective, proposed the ACGLH involving multiple myeloma. research Addi- withdrawn) quently limit of threshold many tionally, years, prepared for Dr. Durie (one 0.5-0.15mg/m3 yd3 m3 one value every publish- summaries of article that was same) essentially weighted time myeloma multiple presented ed on average particulate matter an 8 hour material at the Annual Review of Medicine. workday Using in its recommendation. litigation Dr. Durie was retained in this value, 0.15mg/m3 found Mr. Harris render an as to whether ex- diesel by himself surrounded an environment multiple myeloma. haust caused Dr. Durie proposed average exceeded 8 hour upon testified he relied the Bradford 65-to-130-fold____ limit concentration methodology Hill opinion. render his reports by Dr. Durie reviewed the Envi- my opinion through

It is that Mr. Harris Agency, ronmental Protection International employment by exposed his CSX was Cancer, Agency for Research and Nation- exhaust, high agent levels diesel de- Program Toxicology al of the National Insti- termined scientific and medical Science, tutes of Environmental Health probable likely to be a carcino- human which concluded that diesel con- factors, exhaust gen. Absent other it can be rea- carcinogenic tained that were chemicals sonably concluded'that was a humans, polycyclic.aro- such benzene and major multiple myeloma. factor in his hydrocarbons. report matic He consulted a weight of scientific and evidence medical humans, studies, linking multiple myeloma exhaust with from animal diesel studies exhaust, epidemiologic concerning literature die- using tissues cells diesel multiple closely pyrogenic myeloma. related sel exhaust and re- materials and He involving exposure chemicals known to be in exhaust viewed diesel animal supports benzene, polycyclic hydrocarbons this conclusion as does an under- aromatic which are pitch and blends both of litera- tar Durie reviewed the Dr. pristane. and Heavy carcinogens. metals the loss of known human caused showing that benzene

ture chromosomes, present with known Hams nickel are also and that Mr. such as certain All reinforces damage. carcinogenic potential. this chromosomal the same suffered career, rela- during plausible probable he and causative his testified Dr. Durie and the tionship multi- between diesel exhaust patients thousands has treated multiple myeloma. development “them he asked myeloma and that when ple is, amazing frequent- job how it is what their engineer or that say they’re an

ly they’ll support fact that strongly I And working with chemicals. so they’re workplace Harris the the case of Ronald is a occupations where there occurrence Inc. Transportation exposures at CSX remarkably frequent.” risk of probably than not a causative were more his report written summarized multiple mye Dr. Durie’s development factor relationship of indicating the causal findings loma. myeloma as fol- multiple and diesel exhaust qualifications, method- 4. Dr. Shields’

lows: ology opinion. called Dr. Shields was and group al Martyn T. and the Smith by CSX. Dr. Shields witness as detailed the chro Berkley California have degree in from medical received a changes linked to human benzene mosomal Medicine, New York. Mount Sinai School of in changes exposure. These chromosome approximately 154 published has Dr. Shields specific findings in the bone marrow clude journals. in scientific peer reviewed articles from Ronald Harris.... myeloma cells expertise includes hema- Dr. area of Shields’ manifests a myeloma thus Ronald Harris’s oncology. Dr. Shields is board tology and of ben pattern characteristic chromosomal oncology. medicine and in internal certified exposure. zene 1984-1989, worked as a Dr. Shields Fi’om three medical facilities physician civilian at linage between diesel exhaust Washington, D.C. Dr. Shields served as carcinogen exposure development and the in the United States officer commissioned Ronald multiple myeloma in the case of Corps Public Health Service Commissioned highly plausible thus both Harris is ultimately attained from 1990-199931 probable. Dr. captain. From 2000 to rank of likely than not Of note the more Georgetown faculty at was on the Shields multiple myeloma and association between University Center. From 2006- Medical supported by exposure is diesel exhaust the senior medical Dr. Shields was multiple toxic presence of other the known Center in Capital Breast Care director the] exhaust compounds [such in the hearing in During the Washington, D.C. extensively by studied pristane chemical case, now testified that he was Dr. Shields and known Potter since the 1960’s Michael University employed with the Ohio State in mice plasmacytomata induced [have] Center. Comprehensive Cancer multiple myeloma). (analogous to human to render Dr. was retained CSX Shields at UCLA have shown Recent studies diesel exhaust as to whether in vivo in pristane levels can be measured multiple myeloma. Dr. Shields testi- caused regulatory immune humans and linked to Bradford Hill upon relied fied that he increased B-cell activa dysfunction with opinion. methodology to render his Myeloma derived from abnormal tion. .is addition, that he went on Dr. Shields testified diesel ex B-lymphoeytes. run the National poly internet to a website many of the same haust contained articles of Health and researched hydrocarbons in coal Institute cyclic found aromatic Corps, U.S. Health Serv. Commissioned Corps in a vari- Pub. officers serve 31. Commissioned Servs., http://www. Dep't. Human throughout of Health & ety positions the United States (last usphs.gov/aboutus/mission.aspx visited Department and Human Services of Health 8, 2013). agencies. See United States Nov. certain other federal tems, Inc., dealing multiple president as vice with diesel exhaust Environmen- Toxicology. tal Health and Shields indicated that he re- From 1989to the myeloma. Dr. present, president Dr. Green has been twenty papers that involved viewed more Environmental, Cambridge Inc. railroad workers cancers. Shields from this data that he “inferred” testified by Dr. Green was CSX retained to render myeloma in the was not found that opinion an as to whether diesel exhaust Specifically, because it was not mentioned. multiple myeloma. caused Dr. Green did not myeloma go- Shields stated that “if Dr. any specific methodology indicate that she they’re way describing to arise from the ing However, used to opinion. render her her exposure, Harris’ studies would Mr. these testimony suggests she followed the Brad- acknowledged it.” that show Dr. Shields he Hill methodology. ford study signifi- showed a was aware of a that Dr. Green testified that she does not know myeloma association and rail- cant between any linking any type literature of cancer road workers. Dr. Shields discounted the through pristane. inhalation Dr. because, study study in opinion, his did Green also testified that neither the Environ- implicate as a cause for not diesel exhaust Agency’s mental Protection Health Assess- of the cancers. other studies any Several Engine ment Document for Diesel Exhaust linking myeloma diesel exhaust were Toxicology Program sup- nor the National by significant Dr. found to be Shields. diesel port assertion that exhaust causes that an association between Studies showed myeloma study cancer. Dr. found a Green myeloma rejected by were also benzene Swedish workers Dr. Paolo Bofetta was significant Shields as not to establish Dr. irrelevant, though study even showed opined Ultimately, Dr. Shields causation. exposed that over 800 workers to diesel ex- that, literature, from his review multiple myeloma. haust contracted Dr. no evidence there’s insufficient “there’s study significant Green found the was not in- evidence that railroad workers are at over men because 800 other who were stud- myeloma.” At the creased risk of conclusion myeloma, multiple ied contracted but there examination, of Dr. Shields direct counsel for they exposed was no evidence also were that following question: asked the CSX opined diesel Green exhaust. Dr. that Q. you opinion Do have an as to wheth- engine might lung “diesel exhaust cause can- hypothesis expo- er the in this ease that cer, but there is no credible evidence that it multiple mye- to diesel exhaust causes sure multiple myeloma.” causes proven? loma has been Excluding The Circuit Orders H. Court’s my A. that opinion Yes. It’s it—that Testimony Experts of Petitioner’s proven. it’s not been hesitancy finding in We have no that the qualifications, Dr. methodol- 5. Green’s opinions experts regard- three Petitioner’s ogy opinion. was called Dr. Green as ing the causal link between diesel exhaust Dr. an witness CSX. Green re- multiple myeloma satisfy require- certain technology a Ph.D. in food ceived science opinions ments of Rule Their would 702. Department of Nutrition and Food from “assist the trier of fact understand the Science at Massachusetts Institute of Tech- a fact in evidence or to determine issue.” W. nology published in 1981. Dr. Green has experts three Va. R. Evid. 702. All approximately peer reviewed articles in “qualified expert by witnesses knowl- journals. also scientific She is the author of skill, edge, experience, training, or edu- Safety: “In Search of and Cancer Chemicals Additionally, Id. cation.” (Harvard 1988). University Press Dr. Risk” experts to issues in the was relevant expertise toxicology. Green’s area of Dr. Thus, ques- case. W. Va. R. Evid. toxicologist. Green is board certified tion before us is whether the trial court concluding Dr. Green was a director of Sci- its that the research abused discretion Project reliability Mapping prong entific Conflict at Harvard of Rule was not met. issue, framed, University properly from From 1985- That whether Peti- 1983-1985. Sys- three reliable methodol- employed Green was Meta tioner’s used plaintiff The judgment to the defendant. on the causation rendering opinions ogies in The appellate to a Nebraska court. multiple appealed linking exhaust diesel issue below, plaintiff The then appellate trial court affirmed. explain, myeloma. As we will Supreme Court. appealed to Nebraska’s analysis this narrow issue. exceeded court’s ruling King reversed the Instead, rendering ruling, high court its the court concluding applied it court after Did Petitioner’s the trial jury question: addressed the reviewing the ad- improper Because the standard experts prove causation? three testimony. missibility scope of its narrow exceeded the trial court gatek- King following Rule limited reliability prong of outlined review of the necessary eeper to examine cases role of trial courts: we find it used to the narrow focus have demonstrated Here, dispute Frank’s parties do not reliability the determination. make expert medical testi- qualification give to interpret epidemiological stud- mony toor King Burlington court in begin, To the the broad issue as whether ies. We see Co., Railway Fe 277 Neb. Santa Northern frame- under our (2009), provided an excel- Daubert/Schafersman N.W.2d work, opinion a reli- Frank his based gatekeeper role of analysis of the limited lent valid, able, scientifically methodolo- King, In the wife of a deceased trial courts. (cid:127) gy- (cid:127) (cid:127) brought employee an action former railroad admissibility an determining the In seeking damages against the railroad under opinion, must focus on Liability expert’s the court Employers’ Act.32The the Federal principles validity underlying the contracted the plaintiff alleged that her husband methodology the conclusions that exposure to multiple myeloma due to his —not they generate. And reasonable differ- working while for the diesel exhaust fumes evaluation should not The defendant ences in scientific as a brakeman. railroad opinion. The expert an witness’ plaintiffs exclude the exclude moved the court to evidentiary gatek- up trial court’s role as the expert. opinion King in summed the replace the adver- ruling eeper is not intended to arguments and the trial court’s as expert, sary system to ensure that an but follows: testimony upon profession- basing sup- Differing epidemiological studies experience, employs personal al studies or testimony. experts’ deposition ported the the same level of intellec- the courtroom Frank, expert, Dr. Arthur [Plaintiffs] rigor practice the tual that characterizes multiple myeloma on [decedent’s] blamed sum, field. In an in the relevant course, exposure his to diesel exhaust. Of evidentiary the trial court acts as the while Shields, expert, Dr. Peter G. [defendant’s] goalkeeper. gatekeeper, it is not that the causes disagreed. He believed majority were unknown and that

epidemiological studies failed to show that expert’s ... that an Absent evidence multiple myeloma. diesel exhaust can cause testimony grows expert’s out of the own [defendant’s] The district court sustained expert’s prelitigation research or that an testimony, motion to exclude Frank’s con- subjected peer re- research has been to pass under cluding that it failed to muster view, they that reached experts must show framework. It our following accepted opinions by their Daubert/Schafersman methodology was unreli- reasoned that his procedure it scientific method or because the studies he relied on failed able practiced by field. others their conclusively exposure that to die- state techniques Epidemiological statistical multiple myeloma. sel fuel exhaust causes theory subject testing causation have been King, at 31. 762 N.W.2d peer generally accepted review and are community. Frank plaintiffs The studies After the trial court excluded the scientific review, subject peer King, granted summary upon relied were expert witness it plaintiffs original plain- litigation. 32. The husband was tiff, during pendency but he died develop Appeals the statistical Circuit Court of researchers did not reversed after con- techniques litiga- cluding used in the for this that the trial court exceeded its dis- tion____Accordingly, finding opinion district court need- cretion in plain- that only regarding wrong. to consider issues tiffs’ ed two First Circuit opinion on ... causation. Were the Frank’s outlined limited role the trial court in deciding admissibility epidemiological studies Frank of expert results testimo- support opinion ny: on sufficient to his relied And

regarding ... causation? did he review empowered [TJrial [not] courts are to de- scientific data in a literature or reliable competing termine which of several scienti- words, great did too manner? other fic provenance. theoi’ies the best has analytical gap exist between data and requix’e Daubert does party that a who opinion? Frank’s proffers expert testimony carry the burden proving judge that expert’s assessment of the situation is corx’ect. The We believe court erred in the district proponent only of the evidence must show concluding causation that Frank’s expert’s conclusion has been ar- Frank was unreliable because could not scientifically rived at in a sound and meth- study to a point concludes odologically object reliable fashion. The multiple myeloma. diesel exhaust causes Daubert is to make expert, certain that an explained, epidemiological As individual testimony basing professional on need not draw definitive conclu- studies personal experience, employs studies or sions causation before can con- the courtroom the same level of intellectual agent that an cause a clude can disease. If rigor practice that characterizes the of an expert’s methodology appears other- expert in the relevant field. consistent with the standards set out wise above, expert’s admit long court should So expert’s as an scientific testimo- here, opinion. ny But the court did not in- upon good grounds, rests based on what methodology. known, into quire Frank’s by is it tested should be the adver- pi’oeess, sarial than rather excluded for (internal King, quota- 762 N.W.2d at 42-49 jurors fear that will not be able to handle omitted). tions citations complexities. Vigorous scientific case, it did though Another not involve cross-examination, presentation of eon- multiple myeloma, a which illustrates trial evidence, trax-y and careful instruction on gatekeeper limited role is court’s Milward v. px’oof burden of are the tx’aditionaland Inc., Acuity Specialty Group, Products appropx’iate attacking shaky means of but (1st Cir.2011). Milward, In F.3d admissible evidence. wife, plaintiffs, husband and filed an action against products manufacturers of used in alleged by ... flaws [T]he identified refrigerators. plaintiff The husband worked go weight court of Dr. opin- Smith’s refrigeration plaintiffs as a technician. The ion, admissibility. not its There is an im- alleged that the husband contracted acute portant difference between what is unrelia- (“APL”) a promyelocytie leukemia result support ble a may and what trier of fact exposure to benzene that was contained in support conclude is insufficient for an ex- products. defendants’ The trial court pert’s conclusion. day hearing a four determine held wheth- plaintiffs expert analysis repeatedly er on causation would The be court’s chal- testify lenged underpinnings that caused allowed benzene APL. the factual of Dr. court, opinion, trial opinion, ques- “in a detailed ruled Snxith’s and took sides on proffered testimony eui’rently ‘Dr. that Smith’s that tions that are the focus of exten- exposure to cause APL sive benzene can lacks scientific research and debate —and on reliability clearly sufficient demonstrated scientific which reasonable scientists can dis- this, agree. ovei’stepped to warrant its admission under Rule 702.’” In the court Milward, 639 The trial gatekeep- F.3d at 13. court authoi’ized bounds of its role as thereafter dismissed the action. The er. The of the factual First soundness under- pub- that are not opinion rests on studies analysis and expert’s of the

pinnings peer-reviewed journals and are lished expert’s conclusions correctness 4) flawed; opinion reflects matters their analysis are factual otherwise that based on fact. the relevant litera^ incomplete the trier of review of be determined 5) ture; opinion to articulate underpinning of an ex- their fails the factual When weak, biologically plausible mechanism for ben- it a matter affect- opinion is pert’s myeloma] thus credibility [multiple testi- cause zene to weight and ing the Hill criteria. resolved not meet the Bradford question to be does mony—a jury. by Defen- arguments raised None Dr. Smith’s sum of ... The their motions to ex- support dants in possible, or even merely that it

was persua- Dr. Butler and Dr. Saux are clude that benzene causes biologically plausible, qualified to The two individuals are sive. Rather, testimony was sum of his APL. ..., at least two opinion render factors, includ- the Hill weighing of that a the notion that there is support supported the biological plausibility, ing between statistically significant association ben- the association between inference that myeloma]. The fact [multiple benzene genuine and and APL is zene flawed, that may be those studies causal. against cut the two are studies that there clearly record demonstrates could opinion, and that the doctors doctors’ analy- based on an Smith’s plausible mech- biologically not articulate level of employed he the same in which sis mye- [multiple benzene to cause anism for employs in his rigor that he intellectual weight opinion, of their go all loma] excluding Dr. Smith’s work. academic admissibility---- of question not the and prop- court did not testimony, the district Accordingly, motions to exclude and the scope exceeded the erly apply Daubert and summary judgment must be denied. reverse the district discretion. We of its Wagoner, F.Supp.2d at 800-05. and its judgment for the defendants eourtfs testimony, and we Smith’s exclusion of Dr. Eagle Picker Tech- Finally, in Moreland v. consistent with proceedings remand for (Mo.Ct.App.2012),a nologies, 362 S.W.3d opinion. the ad- appellate court addressed Missouri (internal Milward, quota- at 15-26 639 F.3d opinion its missibility expert under of omitted). and citations tions of a workers’ of evidence in the context rules Corp., Mobil Wagoner employee In v. Exxon in More- claim. The compensation (E.D.La.2011), plaintiff, F.Supp.2d developed multiple mye- alleged that he land decedent, of legal representative years widow and inhalation of a result of of loma as manu- liability against action products employer a plastics filed that his chemicals from benzene-containing products al- in- plastics facturers of produced. The chemicals that, cadmium, benzene, of the decedent’s leging trichloroethylene, as a result cluded benzene, contracted nickel, pro- the decedent exposure employee platinum. and myeloma. The defen- multiple and died of expert witness at the administrative duced an plaintiffs two filed motions to exclude exposure dants to ben- testified that his level who motions, experts. myelo- The basis develop multiple causation him to zene caused same, rejection of the and the district court’s witness employer called an ma. The by the court as follows: were addressed had never been opined that who benzene myeloma. multiple The ALJ proven to cause arguments five have raised Defendants awarded employee and reliability found in favor of of the testi- regard to the 1) ap- benefits. An compensation him ...: workers’ mony Dr. Butler and Dr. Saux of doing the award. pellate not court affirmed on studies that do opinion their rests 2) so, set out appellate court Moreland findings; statistically significant show regaining following relevant discussion on studies that do opinion their relies 3) expert: employee’s causation specifically; their examine benzene (“Dr. Goldstein”), zene, absorption, either air or Goldstein dermal Dr. Bernard both, University a medicine at substantial factor to cause professor compounding [sic] Pub- of cells that lead to mul- Pittsburg Graduate School of [sic] Medicine, tiple myeloma. also lic Health and and School toxicologist, hematologist, physician, Gold- testified on behalf Moreland. Dr. Here, employer] specifically argues [the had tox- stein testified he studied benzene only Dr. that Goldstein’s is not icity published close to one hundred certainty, based on medical and is not upon papers subject since or reviews any based on medical or scientific facts specifically Dr. Goldstein also 1960s. reasonably by experts that upon are relied published and instructed members However, expertise. in the field of medical concerning toxi- judiciary federal on issues extensively explained ... Dr. Goldstein and, of cau- cology particular, the issue many studies which show causation agents sation and chemical should multiple myeloma. benzene between be deemed to have caused or contributed Further, Dr. Goldstein testified that these development multiple myeloma. recognized by sources information are Agency Dr. testified that was Goldstein benzene the International for Research on reasonably probable applied to be a multi- Cancer and could be cause of substanti- ple myeloma upon epidemiological multiple myeloma. ate benzene based that causes Thus, data, bioassays (experiments laboratory facts which on and data on Dr. animals), opinions type mechanistic Dr. Gold- based data. Goldstein his reasonably by experts stein these infor- relied on testified that sources of recognized by mation are the International field.

Agency could for Research Cancer and Accordingly, finding the Commission’s applied be to substantiate that benzene testimony Goldstein’s meets myeloma____ multiple caused required standard

supported competent substantial evidence. multiple Dr. Goldstein testified that (internal

myeloma Moreland, it is an identifiable disease and 362 S.W.3d at 500-04 omitted).33 reasonably probable to ben- citations appeal, 33. In of an On the context administrative workers' reversed the decision of the ALJ. claim, compensation this Court Court reinstated the ALJ's decision. We con- addressed reliability showing issue of the of evidence a link called cluded follows: as exposure between benzene and a cancer expert and The medical literature and fact myelogenous Casdorph v. chronic leukemia. In sufficiently testimony in this case es- witness Commissioner, Virginia West Insurance Ap- that a causal link tablished between Office 94, (2009), 225 S.E.2d 102 claim- W.Va. pellant’s exposure benzene CML existed. ant worked an auto mechanic for State as ‘Appellees Although the that the assert case nearly twenty-two years. Police for After the by showing Appellant cited a causal diagnosed myeloge- claimant was chronic exposure connection between benzene leukemia, filed a claim workers’ nous he for peer get CML have not been able to reviewed (The compensation while print benefits. claimant died acknowledge them as textbooks level). pending the case at the accepted opin- was administrative or medical common ion, consensus studies, alleged The claimant that his cancer was caused although find that we these case small, exposure workplace. peer his to benzene in the valid been studies that have During hearing published. acknowledge, before an ALJ the claimant reviewed We as contend, provided experts, recognized Appellees evidence from several includ- that this Court Infante, 57, ing Leep, "had who testified that claimant v. 212 W.Va. 569 S.E.2d 133 State (2002) ample occupational theory opportunity exposure for “whether a is scientific accepted generally commu- benzene and other solvents contaminated with within a scientific occupation nity” weighed in de- benzene due to his and stated that is factor that must be termining benzene type is a whether to allow is the cause leukemia and CML such However, expo- be of leukemia associated with benzene evidence. we must also remind- Casdoiph, 225 W.Va. S.E.2d Civil and the sure.” at ed that Rules of Procedure strictly apply at 110. The oped found that the devel- Evidence do not ALJ claimant Rules of myelogenous compensation chronic leukemia from his workers' claims. 104-05, Casdorph, 225 690 S.E.2d at to benzene and therefore ruled the W.Va. at (footnote added). important compensable. claim Review to note Board of 112-13 It is Wilt, at 443 S.E.2d at 203. foregoing authorities consistent W.Va. recognized limitation in Wilt has been scope narrow of a trial This ly demonstrate the invariably practice. Litigants have admissibility lost court’s consideration purported trial court calendars with crowded testimony: narrow focus expert [a] scientific evidentiary hearings whenever acknowledged, but which that our cases have Daubert/Wilt testify. expert is called to This was never has been misunderstood. far too often analysis. Therefore, necessary the intent of our it is to care we believe Daubert/Wilt clearly our standard for fully and articulate Gentry Mangum, In 195 W.Va. reliability prong of the admis reviewing the (1995), Cleckley attempt- S.E.2d 171 Justice Thus, testimony. we expert sion of scientific clarify ed to how was to be Daubert/Wilt clear, that, trial hold when a make and so applied by “giv[ing] guid- circuit courts more upon the admissi is called to determine court procedural standpoint in resolv- ance from testimony, in decid bility expert of scientific ing Gentry, evidence scientific issues.” admissibility the ing “reliability” prong of Gentry at 466 S.E.2d at 180. W.Va. inquiry limited to of the trial court’s is focus that, pointed crystal out in clear terms expert employed a determining whether the validity [actually, issues most scientific in the scienti methodology recognized that is judicial pur- notice will be resolved under community rendering an on fic Indeed, most of the suant to Rule 201. If subject under consideration. expert testimony is offered cases in which methodology recognized is the scientific disagreeing only qualified experts involve community, then determine the court should data that was interpretation about the correctly expert applied the through methodologies. obtained standard methodology opinion. or her If to render his upon unlikely impact Daubert/Wilt satisfied, and the testi two factors are these Therefore, circuit courts are those cases. relevant, and mony been found to be has evidence without right to admit or exclude may testify at qualified, “reinventing every wheel” time re- trial. put proof full quiring parties to invalidity principles. clarify validity that the standards out- of scientific We wish to judicial appropriate, principles are not new under this notice is lined above Where jurisprudence. These it. circuit court should use Court’s Daubert/Wilt always implicit part principles have been at Gentry, 466 S.E.2d 195 W.Va. put, analysis. Simply of the Daubert/Wilt Gentry, Cleck- Syllabus point 4 of Justice however, been principles these have not Dau- ley simplified and reformulated our clearly by trial courts. understood or followed standard as follows: bert/Wilt instance, following this Court made the For proffered, a scientific evidence is When in Wilt: observations “gatekeeper” role under circuit court in its that, ... are of the view under Rule We Pharmaceuticals, Daubert v. Merrell Dow 702, category expert testimo- there is 579, 2786, Inc., 509 U.S. 113 S.Ct. ny methodology that is based on scientific (1993), Buracker, and Wilt v. L.Ed.2d 469 generally recognized longstanding so (1993), 39, S.E.2d 196 cert. 191 W.Va. and, noticed, may judicially that it be denied, 511 U.S. 114 S.Ct. therefore, a trial court need not ascertain (1994), engage in a two L.Ed.2d 867 must reliability. the basis for its analysis regard expert in testi part First, Thus, mony. court must deter is direct- the circuit we believe that Daubert testimony expert reflects the scientific or mine whether ed at situations where knowledge, findings whether the expert testimony scientific technical basis for the method, hearing by scientific judicially cannot be noticed and a are derived good reliability. product amounts to whether the work must be held to determine its compensation litigation. Casdorph apply Cas- made clear that it to workers' that the decision in dotph distinguishable evaluating admissibility from Moreland in that was not applies regard rules of evi- testimony evidence, because Missouri its under the standards of the rules of litigation. strictly compensation did not dence to workers' because those rules Second, the accepted science. circuit court must methodologies. In such a case, ensure that the scientific is rele- the focus general from the moves vant to the task at hand. reliability specific concerns ... to the reli- ability procedures gener- followed to 512, 466 171. 195 W.Va. S.E.2d proffered ate the evidence and whether Gentry attempted to show that a full they establish a foundation for the recep- evedentiary analysis blown Daubert/Wilt tion of the evidence at trial. required only evaluating for a new and/or Nonnon, 932 N.Y.S.2d at methodology. novel scientific 435. Recognized methodologies subject judicial are the no case, In the instant the trial Moreover, explained Syl tice. Court in by court holding erred a mini-trial to set out point Mayhorn Logan labus four of Medi and resolve purely issues that were matters Foundation, cal 193 W.Va. 454 S.E.2d 87 jury for consideration.34 The three orders (1994), that excluding Petitioner’s three set out [p]ursuant Virginia to West Ev- Rules of array resolved an disputed factual expert’s opinion idence 702 an is admissi- exclusively matters that were grist for the methodology employed by ble if the basic jury and which had relevancy no to the limit arriving in at his ed role the trial court had under the facts of scientifically technically prop- valid and instance, this case. For as noted Petition erly applied. jury, and not the trial er, the orders found: judge, weight given determines the to be 1. If a difference between a case group expert’s opinion. group and control statistically signif- is not Palmer, Cleekley, 2 Franklin See D. Louis J. icant then there is no difference at all. Davis, Jr. and Robin Jean Handbook on Evi- acceptable 2. It is practice scientific Virginia Lawyers dence for West interpret study as “not different” a that (5th 2012) (“The § 702.02[2][e] ed. [Dau- shows elevated risk that is not statisti- regime contemplates bert/Wilt] trial cally significant. perform function, judges will a gatekeeping substantially 3. There is more benzene determining methodology whether the ... cigarette in smoke than diesel exhaust. underlying proffered expert testimony is sci- entifically present 4. only valid and whether ... Benzene is meth- trivial odology properly doses in applied can diesel exhaust. be to the facts issue.”). We note that we are not alone hypothesis 5. The that diesel exhaust limiting evidentiary hearing to determine multiple myeloma causes is confounded reliability experiments conducted for cigarette the fact that smoking does not. litigation novel methodology. scientific and/or epidemiologic Most studies must be York, City See Nonnon v. New 88 A.D.3d positive purported causal association to (2011) (“[W]e 932 N.Y.S.2d be real. plaintiffs’ [have] determined that expert evi- (47) forty-seven 7. Of diesel require dence did hearing that a be held (8) exposed only eight purport workers [because] neither the deductions of the ex- positive. be pert epidemiologists toxicologists, nor epidemiologic 9. The literature investi- methodologies them, employed by gating a causal association between rail- reaching premised their conclusions are employment multiple myeloma road and (internal ... quotations novel scienee[.]” and supportive null and subject not omitted)). hy- the citations The court in Nonnon pothesis. observed that

epidemiology toxicology hardly (10) and are 10. There approximately are ten sciences, rather, novel but published well-established investigating [sic] causal fully litigants 34. This Court is aware that unequivocally have is intended to make judges abused the limited admissibility principles resources of our trial clear that the under Dau- by demanding evidentiary hearings full-blown in were never intended to allow the abuse bertfWilt testimony most cases where is offered. that has become routine in our trial courts. 648 contrast, myelo- experts multiple In stark the in the instant

link between benzene positive. ma. None of them are case did new or not offer novel methodolo- toxicological, gies. epidemiological, The re- The literature epidemiologic 11. weight of evidence Bradford Hill the mye- multiple garding PAH methodologies they recognized used are hypothe- the support subject does loma highly respected community. in the scientific sis. And, opinion, as is detailed in this those 42 was 12. IARC Technical Publication applied experts methodologies the consistent- a state- to make causation not intended ly rigor with the “level of intellectual that agenda. express a ment but to research practice expert in characterizes the of an the hypothesis general The causation 13. Milward, relevant field.” 639 F.3d mul- exposure to diesel exhaust causes that myeloma been tiple proven. has not findings by

Clearly, the made the above IV. never have considered trial court should been in part gatekeeper of its limited role this as CONCLUSION dis- findings All of above involve case. the the circuit orders We reverse court’s ex- They opinions experts. puted between cluding of Petitioner’s three nothing reliability have to do with Furthermore, experts. we reverse the order by ex- methodologies the Petitioner’s used granting summary judgment in favor of fact, CSX. In trial perts. court could have relevancy Finally, question this case is remanded for further resolved reliability experts through ar- Petitioner’s opinion. with proceedings consistent by parties their guments and without Reversed and Remanded. testimony. undisputed It is experts’ methodologies by ex- employed Petitioner’s

perts recognized are in the scientific commu- Justice LOUGHRY dissents and reserves experts upon nity. Ironically, CSX’s relied right dissenting opinion. file a methodologies. There is also no the same three ex- dispute reasonable that Petitioner’s Justice, LOUGHRY, dissenting: employed methodologies in a man- perts reaching In its decision that the trial court they employed consistent how in ner community. only excluding petitioner’s expert wit- the scientific issue erred nesses, in dispute majority utterly appreci- that was was whether Petitioner’s failed reaching were the conclu- correct following ate the observation made Dau- they Challenging the latter sions reached. Pharmaceuticals, Inc., v. Merrell Dow bert jury for issue is matter determination.35 (“Daubert (9th Cir.1995) II”): 43 F.3d 1311 “[Sjomething doesn’t become ‘scientific will where a We understand there be cases knowledge’ just because it’s uttered method- party seeks to a new and novel offer scientist; expert’s self-serving can an nor causation, party’s ology explain or where a were assertion that his conclusions ‘derived expert performed specific experiment by the scientific method’ be deemed conclu- trial to show causation. either those And, ...” situations, sive. Id. at 1315-16. Ninth rigorous prong of the Dau- II, analysis explained expert’s “the gatekeeper implicated. Circuit Daubert bert/Wilt Inc., Grp. F.Supp. courts Sutera Perrier Am. 986 35. This Court is aware some have expert testimony (same); (D.Mass.1997) wheth excluded on the issue of v. Union Richardson multiple myeloma is caused diesel exhaust. er Co., App. Pac. R.R. Ark. 386 S.W.3d 77 Co., F.Supp.2d Ry. Aurand v. S. See (2011) Navarro, (same); Norfolk Missouri Pac. R.R. Co. v. (N.D.Ind.2011) (excluding plaintiff experts 950 on (same). (Tex.Ct.App.2002) 90 S.W.3d States, myeloma); multiple Morin v. United decisions courts in cases are incon- those (D.Nev.2005) (same); F.Supp.2d Cas admissibility of sistent with the standards of sci- USA, F.Supp.2d v. 97 780 tellow Chevron expert testimony entific that followed in this (same); (S.D.Tex.2000) Estate v. Gen Mitchell of jurisdiction. Inc., (same); (D.Kan.1997) corp, F.Supp. 968 592

649 validity enough.” explaining scope assurance of is not the appellate bald review of To that the “ex- gatekeeping rulings, Id. at 1316. demonstrate Daubert Justice Cleek- science, pert’s findings ley expounded are based on sound Gentry in Mangum, objective, independent 512,466 (1995): ... some validation of W.Va. S.E.2d 171 expert’s methodology” required. the Id. In applying the standard of review that we Complying pivotal gatek- with its role as a adopted in Beard and in eases other than eeper, carefully thorough- the trial court resulting summary those judgment, we ly by reviewed the conclusions reached the have held a circuit court has broad discre- petitioner’s expert three witnesses and con- determining tion in the relevancy scien- opinions grounded cluded their were not evidence and this Court will sustain tific scientifically properly applied valid and ruling the circuit ruling court’s the unless methodology. Given the trial court's unas- is a clear abuse discretion. On the analysis, majority unequivocally sailable hand, other our granting review of the overstepped authority reversing its a deci- summary judgment and of a circuit court’s wholly subject sion trial court’s discre- regarding determination whether the sci- Joiner, tion. See Gen’l Elec. Co. v. 522 U.S. properly subject evidence was entific 136, 146, 512, 118 S.Ct. 139 L.Ed.2d 508 technical, “scientific, specialized or other (1997) (“We hold, therefore, that abuse of knowledge” is de novo.” proper discretion is the standard which to 519, Id. at (emphasis 466 S.E.2d at 178 sup- ... review a court’s decision to admit [trial] plied). evidence.”) or exclude (emphasis scientific In parties those cases where dispute supplied). subject the evidence is to the Dau- overarching purpose of the trial principles, question there is no bert/Wilt gatekeeping largely court’s role is eviscerat- applies this Court a de novo review to resolve majority’s ed decision to resort to the question presented of law and to ascer- threadbare “admissibility touchstone of ver- tain that the correct applied. standard was weight sus of the evidence.” Reliance on this Int’l, Inc., See Wendy’s San Francisco v. prosaic evidentiary yardstick is both short- 734, 740, (2007) 485, W.Va. 656 S.E.2d sighted demonstrably imprudent. Rath- (stating that required de novo review is erring admissibility er than on the side of determine whether applied proper trial court forcing jury experts’ to sort out the standards under deciding Daubert/Wilt opinions, preferred outcome is to allow whether to admit or exclude testimo- court, case, the trial it as did this ny and to ascertain whether the evi- perform the critical evaluations inherent “scientific, technical, dence was or otheiwise required by gatekeep- the Daubert/Wilt specialized knowledge”) (quoting Gentry, ing function.1 And when the trial court syl. pt. W.Va. 466 S.E.2d at 3 in role, properly performs appellate its court ease, part). In this dispute there was no reached, respect should barring the decision expert testimony being subject to the a clear abuse of Finding its discretion. no gatekeeping well-established principles as clear abuse of discretion on the facts of this parties regarding concurred the use of case, I respectfully must dissent from the these standards. The record of this case majority’s decision. performed makes clear that the trial court its Standard of Review assessing expert’s duties of proposed tes- declaring In applicable standard timony purposes of re- reliability and rele- ease, 2, Wilt, view to be de novo in this majority Syl. vance. See Pt. 191 W.Va. completely misapprehends result, both what 443 S.E.2d 196. As a the respondent previously recognized Court has gov- correctly as the CSX argued the trial court’s erning determination, standard that controls these eviden- upon application Dau- tiary rulings proper as well as scope gatekeeper analysis, was reversible bert/Wilt its review of ruling. only the trial court’s upon an abuse of discretion. Pharmaceuticals, Buracker, (1993); 1. See Daubert v. Merrell Dow Wilt v. 191 W.Va. Inc., (1993). 509 U.S. 579, 113 S.Ct. 125 L.Ed.2d S.E.2d 196 650 appellate review de construed the critical limitations on agree “[w]e that

Other courts rulings. whether the court review of these question [trial] the novo actually per- applied proper the standard Moreover, majority seriously the went as- in the first in- gatekeeper role formed its tray by wrongly injecting itself in this case Corp., 328 F.3d Dodge v. Cotter stance.” clearly a matter reserved for the trial into (10th Cir.2003); accord Jenkins v. court’s discretion. When it suits the author Cir.2007) (7th Bartlett, F.3d majority, justice that subscribes properly court (stating that the district “[i]f following “Under abuse of discre- standard: framework, we then re- applied the Daubert review, judg- we substitute our tion do not ultimate decision to view the district court’s Tay- circuit ment for the court’s.” State testimony the for an admit or to exclude 74, 83, lor, 593 S.E.2d 215 W.Va. discretion”). Kentucky the Su- abuse of As (2004) (Davis, J., dissenting). By erroneous- appellate sagely explained, preme Court ly declaring of review to be the standard supposed duplicate gatek- the court is not regard plenary with to the trial court’s deci- already performed by eeping analysis admissibility sion on the testi- trial court: mony, majority wholly “disregarded] trial courts as to the The decisions of limited nature of our review.” Id. admissibility witness Expert generally under Daubert are entitled to Exclusion of Witnesses appeal on because trial courts deference At the center of the trial court’s decision position are in the best to evaluate first by plaintiffs that the conclusions reached such, proposed hand the evidence. As expert witnesses were not reliable was its subsequently appellate court re- when respective that related determination ruling, Daubert it views the trial court’s experts were not opinions of the three apply must the “abuse of discretion stan- scientifically proper- grounded on a valid and dard.” ly methodology. reaching In that applied (Ky. Eldridge, 146 S.W.3d Miller v. court, decision, reviewing the the trial after 2004). subject to de novo review is What proffered testimony each of the three ex- reached, findings but in- not the individual inadequate perts, ruled that there was evi- application the “court’s of the Daubert stead opinions and conclusions of dence that framework, i.e., whether the court as- [trial] Infante, Goldstein, and Durie had been Drs. reliability relevance of the sessed the subjected peer publi- tested or review Bartlett, testimony.” 487 F.3d at proffered An that the trial cation. additional flaw 489. recognized the failure of those court looking solely unsupported dicta in opinions potential to have an actual or known Wendy’s as the basis for its de International grounds are the exact error rate. These standard, majority reviewing novo initially by grounds articulated the United only appreciate the standard that fails to and later Supreme States Court Daubert Cleckley and this Court Justice articulated Wilt, by progeny, and its as a this Court also, taking the bait set adopted, but after rejecting proffered expert testimo- basis for Wendy’s Interna- former Justice Stareher “scientific, technical, ny concerning or other tional, wholly between blurs distinction 702; knowledge.” specialized W.Va.R.Evid. decidedly appellate that is limited to review Daubert, 593-94, at 113 S.Ct. see 509 U.S. proper standard was recognizing Wilt, 2786; at 443 S.E.2d at W.Va. reapplication applied and a wholesale gatekeeping appeal.2 Through standard petitioner prove through seeks underpin- What patent its failure to examine exposure to exhaust her is that diesel nings the standard of review for Dau- majority specific type of cancer —mul- length, mis- fumes causes cases bert/Wilt reaching criticizing express purpose irony that in trial” —for 2. The cannot be missed conducting a "mini trial” —(cid:127) the circuit court for that reached conclusion different than exactly required what is under DaubertfWilt- —the trial court. majority simply to conduct its own "mini chose And, acknowledged yet, Infante that tiple myeloma. not one none of the 8 proffered experts Ms. Harris selected papers meta-analysis three in the included Sonoda diesel any scientific evidence that ex- valid mention exhaust.” In diesel this same fash- myeloma.3 exposure multiple causes haust ion, study the trial court dissected another he necessary to make causal failure (IARC upon relied Technical Publication exposure between diesel fume connection 42) Number as well as Dr. Infante’s own myeloma, correctly multiple trial court meta-analysis. that, The trial court found reasoned, is critical. See Richardson Un- expressing rather than a judgment as to Co., App. R.R. 2011 Ark. ion Pacific causing multiple myeloma, diesel exhaust (2011) that (recognizing toxic S.W.3d merely single Publication 42 paper cited a required prove gener- plaintiff tort to both agenda an and declared for future research. causation);4 Black v. specific al and see also Many papers upon Dr. Infante relied (5th Lion, Inc., Cir. Food F.3d conducting meta-analysis his own do 1999) (“The any underlying predicates of even mention diesel exhaust. im- Of further testimony are medical cause-and-effect port to the trial court was the fact that Dr. science physiologi- medical understands the Infante excluded Boffetta a seminal process particular cal which a disease or study in Sweden conducted that involved mil- syndrome develops and knows what factors specifically people lions of directed at exam- occur.”). process summary to A cause the ining possible effects of diesel exhaust the trial court with deficiencies found occupations including various railroad work- upon each regard experts to of the three occupation specific ers —the of Mr. Harris. proffered of their fol- examination study That reached conclusion that diesel lows. exposure statistically exhaust insignifi- Dr. Infante causing multiple myeloma.5 cant in Infante, occupational an environmental deciding that “Dr. Infante did not meet epidemiologist, methodology testified that his science,” good demands the trial court evaluating consisted both animal studies considered his failure to include the Boffetta concerning and literature constitu- selected study familiarity 2001 in his and his lack of exhaust, including ents of diesel benzene with the EPA Health Assessment document pristane. The trial court that Dr. related specifically targeted at engine diesel ex- meta-analysis upon had relied re- Infante properly haust.6 trial opined, As the court 2001,” reaching ferred as “Sonoda his appropriate good is not in a “[i]t scientific potential that there for die- conclusion was a methodology ignore causation will- or be sel exhaust to be associated an fully contrary unaware evidence.” The multiple myeloma. elevated risk of “Dr. In- trial court concluded that Dr. Infante “limit- fante testified on direct that So- examination expression opinion [to] ed his of ‘associa- noda 2001 considered 8 case-control studies multiple tion’ diesel between exhaust and specific engine it con- exhaust and stated myeloma” express “did not engine cluded that diesel and non-diesel ex- Yet, multiple myeloma.” multiple myelo- that diesel exhaust causes haust causes as the found, recognizing testing, “[o]n trial court cross examination Dr. ma.” the lack After only partic- 3.Dr. Durie was the one that testified "General causation addresses whether a agent particular Specif- ular can cause illness. multiple myeloma. Be- diesel exhaust causes agent ic causation addresses whether that in fact his own research not resulted cause efforts had particular plaintiff’s caused the illness.” Rich- however, finding, in that his was of conclusion ardson, omitted). (citations 386 S.W.3d at 80 questionable very value. See "One Daubert II: significant assessing factor to be [in considered exposed multiple developed 5. 865 diesel men reliability] experts scientific is whether the myeloma compared exposed to 860 non-diesel proposing testify growing about natu- matters men. rally directly they out of have con- research independent litigation, ducted or 6. That evaluated all assessment 29 rodent studies they developed expressly opinions their for have inhaled conducted on diesel exhaust and deter- testifying.” purposes of 43 F.3d at 1317. mined that none of them resulted in a conclusion multiple myeloma. that diesel exhaust causes review, Myeloma organization publication Dr. Infante’s peer Foundation —an conclusions, trial which he chairman. opinions and serves as scientific opinions that “his are little court determined peti- Of the three offered speculation imagination.” or than rank more tioner, only Dr. Durie was the one who actu- Goldstein Dr. ally testified that diesel exhaust causes multi- ple myeloma. validity, In terms of scientific disclosing fact the that Dr. Gold- After however, clearly testimony was the his weak- litigation of source income is stein’s “sole proffered by petitioner. est evidence consulting,”7 the trial court addressed concluding opinion that Dr. Durie’s lacked testimony. of his In con- constrained nature predicate requisites reliability, the tri- had cluding opinions his not been sub- that al court reasoned: review, ject testing, publication, peer to requirements Dr. to the Durie testified the trial court found: “good employ did not science” but them restricted evaluation to Dr. Goldstein his supporting opinion in his that ex- diesel only “biologic plausi- pertaining that myeloma. multiple haust He causes relied subject hypothesis. He fur- bility” of the on the review of Peter Infante literature himself to ther restricted the consideration employ methodology who did not himself studies, studies not animal which are grounded good Despite in science. Dr. determining “biologic plausi- to suited testimony Durie’s that opinion diesel ex- hypothesis bility” subject there as multiple myeloma, haust causes he not has no relevant animal model. He was exists expressed opinion in this causation his own any specific support- unable to cite published writing multiple on the causes of opinions ing specific regarding his diesel myeloma, Myelo- International nor has the exhaust, pur- its constituents and their Foundation, organization ma of which ported ability multiple myeloma to cause opinions he is Dr. Durie’s chairman. about Moreover, he humans. to an testified myeloma multiple largely causes organizations awareness that such as unsupported by to relevant citations scien- EPA have IARC and U.S. not concluded tific literature. multiple myelo- exhaust causes that diesel humans, (emphasis supplied) ma in only Not does a trial court have the discre- expert presenting tion to from exclude an examination, the trial Upon court concluded opinion sufficiently tied to that is not reliable paid opinion simply Dr. Goldstein’s that data, expert opinion but “when an is based on necessary of scientific lacked foundation data, methodology, that or studies are sim- reliability. ply inadequate support to the conclusions Durie Dr. reached, Daubert ... mandates the exclusion Durie, testimony.” physician opinion certified in internal of that Dr. unreliable Amor- medicine, Co., hematology, oncology, gianos Passenger testified v. Nat’l RR 303 F.3d (2d Cir.2002). myeloma. multiple Cleekley that diesel exhaust causes As Justice “ conclusion, explained In reaching Gentry, ‘nothing he relied on the in the Rules regard appears of Dr. Infante with to have been [of Evidence] to intended epidemiologic permit speculate to literature well as his own fashions experience. unsupported by clinical While Dr. Durie au- ... the uncontroverted evi- ” paper Ep- causation “The dence.’ at 466 S.E.2d thored one entitled 195 W.Va. at 186 Myeloma,” Systems, idemiology Multiple paper (quoting Hy-Way Heat Newman (4th Cir.1986)). Inc., not even mention diesel exhaust. As does F.2d Criti- noted, cally, petitioner majority the trial court Durie was im- neither the nor the peached directly exigent the absence of ever on diesel exhaust addressed flaws multiple by regard identified fumes as an identified cause for the trial court with proffered testimony. myeloma the website for the International II, workplace "in As the Court commented Daubert fact a scientist’s normal the lab field, determining proposed lawyer’s or the the courtroom or the not science, good may ignore we office.” 43 F.3d at 1317. amounts By viewing general this case as one where the trial causation before proceeding to the wrongly court focused on the conclusions specific issue causation. King, See by experts, majority misap- 34; reached Richardson, N.W.2d 386 S.W.3d at 80. prehends the interwoven nature of the meth- nothing This is Apparently, majori- new. odologies Rejecting and conclusions. the ar- ty sought to brush this legal compo- critical gument that the conclusions reached an nent of a FELA case under the rug failing expert should never be the focus of a Dau- assignment discuss this of error and the inquiry, Supreme bert the United States corresponding focus of analy- the trial court’s cogently explained in Court Joiner: light sis in requirement of this general methodology But conclusions are not causation. entirely distinct one another. from reflection, Upon I am left with the firm experts commonly extrapolate Trained opinion that majority the has failed to com- existing nothing from data. But in either prehend import stan- Daubert/Wilt Daubert or the Federal Rules of Evidence Experts dard. permitted are not to “hide” requires opinion a district court to admit psuedoscience behind and studies as the existing evidence that is connected to data Supreme United States Court made clear in only by ipse expert. dixit of the A upholding Joiner. the district court’s de- may simply court conclude that there is cision to refuse to plaintiffs experts admit great analytical gap too between the they because had failed to show a link be- data proffered. and the That is exposure tween to lung PCB’s and small-cell here, what the District Court did and we cancer,9 high exactly court did what the hold that it did not abuse its discretion in majority faults the trial doing court for in doing. so this case: looked behind experts’ opin- (citation 522 U.S. at 118 S.Ct. 512 omit- to ions determine whether the cited studies case, and emphasis supplied). ted In this as supportive were in fact of the conclusions case, any plaintiff in toxic tort must reached. connectivity establish the causal of the chem- component particular agreed petition- ical District Court disease or injury. that King Burlington See ers the animal N. Santa Fe studies on which re- Co., Ry. spondent’s 277 experts Neb. relied support N.W.2d did not (2009); Richardson, 386 S.W.3d at 80. As a exposure his contention that to PCB’s had result, expert testimony sup- need for contributed to his cancer. The studies in- ply that critical causal connection is often the volved infant mice that developed had can- key plaintiffs to a especially, toxic tort being exposed cer after to PCB’s. The case— this, in general cases such as where causa- infant mice in the studies had had massive yet tion has to be established.8 injected directly doses of PCB’s into their peritoneums or stomachs. Joiner was an Inexplicably, majority altogether failed being alleged exposure adult human whose assignments address two of the of error to PCB’s was far less than the in that were in raised this case. The omitted the animal studies. The PCB’s were in- question issues concerned the of whether jected highly into the mice in a concentrat- there is a reduced standard for the admissi- ed form. bility The fluid with which Joiner had expert opinions in FELA cases and generally general come into contact had a much proved whether causation must be smaller PCB a toxic tort concentration of between 0- plaintiffs case before a FELA expert testify parts per to-500 specific can as to million. The cancer these causation. In castigating developed mice alveologenic the trial court for its focus adeno- mas; “right wrong,” or majority developed what the failed Joiner had carci- small-cell comprehend is study that the substantive law that nomas. No demonstrated that adult applies requires to FELA showing developed cases being exposed mice cancer after ” Joiner, supra 8. See 4. unsupported speculation.’ note 522 U.S. at (citation omitted). 118 S.Ct. 512 The trial court believed that the testimo- ny 'subjective at issue "did not rise above belief observed, experts that As one court “Daubert com- admitted has One of to PCB’s. court, that PCB’s mands that science must do the study had demonstrated no speaking, merely not Cavallo scientist.” any species. other cancer lead to (E.D.Va. Enter., F.Supp. v. Star (footnote 144, 118 omit S.Ct. 522 U.S. 1995). By simplistically viewing the mere ted). qualification as an as all that was Continuing, stated: the Court Joiner necessary get opinions of these ex- reply criti- Respondent failed to to this perts jury, majority missed before the explaining how and Rather than tack, cism. And, by taking the mark. extrapolated have why could majority indirectly trial court’s shirked the seemingly far- opinions their from these gatekeeping is not duties. When Daubert studies, respondent chose removed animal applied keep unreliable “sci- as intended —to only proceed [was] as if the issue “to entific” evidence out of the courtroom —the prop- can ever be a whether animal studies speak, plaintiff only gets pass, so to but expert’s opinion.” for an Of er foundation objective assuring experts employ course, animal can ever be rigor” in their court- the same “intellectual expert’s opinion proper foundation for an room as in their relevant field is was whether was not the issue. issue Co., v. thwarted.10 Kumho Tire Ltd. Carmi- sufficiently experts’ opinions were these 152, 1167, chael, 137, 526 U.S. 119 S.Ct. animal studies on which supported (1999). that, only Not but to L.Ed.2d 238 they purported rely. The studies were seemingly prophetic words of the borrow the presented to the facts this so dissimilar author, majority majority’s “I fear that the litigation that it was not an abuse of dis- beyond simply opinion will metastasize have for the District Court to re- cretion carefully crafted case and hazard all of our them. jected experts’ reliance on jurisprudence.” Taylor, ... [Daubert/Wilt ] (Davis, J., at 593 S.E.2d at 658 215 W.Va. (citation 144-45, omitted 118 S.Ct. 512 Id. dissenting). Accordingly, compelled I am Simply put, emphasis original). respectfully dissent. professed accepted meth- expert’s reliance enough. gatekeeping odologies is not imposed under

responsibilities DaubertfWilt to determine whether require examination through reached that methodolo- if, inquiry, upon itself valid—and gy is sound, gate scientifically opinion is swing supposed shut. majority law. ed from and been in accord with federal The ease with which the dismisses Inc., Transp., n. contrary authority 232 W.Va. with our stan- See Harris CSX as inconsistent admissibility quite alarming n. 2013 WL 6050961 all of 753 S.E.2d dards for (2013). previously both emanat- our law on this issue has

Case Details

Case Name: Deborah Kay Harris, Administratrix v. CSX Transportation

Court Name: West Virginia Supreme Court

Date Published: Nov 13, 2013

Citation: 753 S.E.2d 275

Docket Number: 12-1135

Court Abbreviation: W. Va.