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Casebook, First Edition, July 1999 Lakie v. Smith-Kline Beecham: Reaching the Jury With Imperfect Evidence How strict is the standard of scientific proof for causation just so a claim for toxic chemical injury may reach a jury and not be declared inadmissible? The District Court of Washington, DC, in Lakie, 965 F.Supp. 49 (D.D.C. 1997), denied the defendant's motion for summary judgment sought on grounds that plaintiff's expert testimony was inadmissible under Daubert. At issue was how rigorous is Daubert's standard of proof, not for a jury to find causation with sufficient certainty, but just to take a claim before a jury. This case raises particular issues of science regarding the evidentiary need for:
Absence of positive epidemiological studies specific to the plaintiff's theory of causation. The court found it is not fatal to the admissibility of expert testimony under Daubert, especially where the disease is a rare disorder, as long as the methodology employed is sound. The court cited recent review of Benedi v. McNeil-P.P.C. Inc., 66 F.3d 1378 (4th Cir. 1995). In Lakie, myelodysplastic syndrome (MDA), a bone marrow disorder clearly linked with exposure to benzene, was accompanied by deletion of the long arm of the fifth chromosome (5q-minus). The 5q-minus variant of MDA occurs at a rate between 1 in 100,000 and 1 in a million. Such a rare variant itself cannot be the subject of epidemiological study, as such a study would have to cover the whole U.S. population. But all MDS disorders collectively have been studied carefully and clearly linked to benzene exposure. The court found the plaintiff's theory of causation in Lakie to be a far cry from the theories advanced by plaintiffs in the Bendectin cases, where an overwhelming body of epidemiological evidence had contradicted the experts' conclusions. Raynor v. Merrell Pharmaceuticals, Inc., 104 F.3d 1371 (D.C. Cir. 1997).
Absence of peer review of plaintiff's expert's proposed theory of causation. The Supreme Court, in Daubert, declared the fact of peer review and publication to be a "pertinent" factor in the gatekeeping inquiry, but found that "some propositions . . . are too particular, too new, or of too limited interest to be published." 113 S. Ct. at 2796-97. In fact, the general theory of MDS, not of the rare variant, had been published and peer-reviewed extensively. Absence of a differential diagnosis that eliminated all causes other than benzene exposure. The court deemed it was not particularly significant that doctors could not eliminate a spontaneous mutation of a chromosome as an alternative cause, nor must the expert eliminate each and every possible alternative cause. This was found especially true where a plaintiff could establish a definitive link between the causative agent (benzene) and the general condition it produced (MDS). Raynor, at 1375-77. In citing Mendes-Silva v. United States, 980 F.2d 1482, 1487 (D.C. Cir. 1993), the court observed: The fact that several possible causes might remain "uneliminated" only goes to the accuracy of the conclusion, not the soundness of the methodology. Absence of an exact level of exposure and dose. Defendants argued that the benzene content in contaminated denture adhesive varied from lot to lot and plaintiff's experts relied on testing samples other than those actually used 10 years earlier, so there was no reliable evidence of the benzene amount actually absorbed. But the court declared the plaintiff should not be held to such an exacting standard of proof, and drew a comparison with cases such as Christopherson v. Allied-Signal Corp., 939 F.2d 1106 (5th Cir. 1991), where there was no credible information regarding dosage. The contribution of this case to applications of health science in litigation is to clarify the standards of scientific proof for disease causation, such as the specificity and quantitation required, that are reasonable in view of the more-probable-than-not legal standard and reliable enough to present to a jury. [Contributed by Wayne Roth-Nelson] CLASSIFICATION: CIVIL LITIGATION; TOXIC CHEMICAL INJURY; ADMISSIBILITY OF EVIDENCE FOR CAUSATION
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