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Toxicology and the Law Chapter | 11  189




  VetBooks.ir  were excluded, and the exclusion affirmed because the lit-  from exposure to a toxic dose of the chemical
                                                                           in question? Is reliable testimony of the clini-
             erature did not support a finding of general causation at
                                                                           cal signs and lesions available?
             the relevant exposure (Amorgianos, 2002). Testimony of
             a toxicologist was properly excluded because he per-     2. Rule-out:
             formed no dose assessment and showed no statistically       a. Can the expert provide a differential diag-
             significant link between the chemical and the type of can-    nosis list?
             cer present (Burleson, 2004).                              b. Can the expert provide reliable testimony
                Reliance on peer reviewed literature is also impor-        that the diseases other than the purported
             tant. A toxicologist’s testimony was excluded, but the        one were ruled out? Can the expert explain
             exclusion was reversed, because the toxicologist’s            how and why these other diseases were
             testimony was supported by peer-reviewed literature           ruled out? Were scientifically valid meth-
             (Bocanegra, 2003).                                            ods used to rule out these diseases?
                                                                  When considering exposure: 45

             SOME QUESTIONS TO CONSIDER WHEN                    1. How can we be sure that the samples taken are actu-
                                                                   ally representative of the media sampled?
             USING LABORATORY RESULTS
                                                                2. Standard methods are available to design sampling plans
             1. Was the legal aspect of the case known at the time the  that have specified probabilities of being representative,
                samples were submitted? If not, is the sample tracking  but they can never provide complete assurance.
                or chain of custody sufficiently well documented to  Generally, when contamination is likely to be highly
                establish each relevant step of the analysis? Can the rel-  homogeneous, there is a greater chance of achieving a
                evance of the documents be authenticated? Does chain-  reasonably representative sample than is the case when it
                of-custody or sample tracking documentation exist?  is highly heterogeneous. In the latter circumstance,
             2. What type of legal venue is the work to be used in ?  obtaining a representative sample, even when very large
                Administrative enforcement, civil litigation, criminal  numbers of samples are taken, may be unachievable.
                litigation? What standard of persuasion is appropriate  3. How can we be sure that the analytical work was done
                for this venue?                                    properly?
             3. Can the relevance of the analytical results be authenti-  4. What are the pathways from the source to the exposed
                cated? What documentation exists that the samples were  individuals? How has it been established that those
                collected from the appropriate animal? What documen-  pathways exist (past? present? future?).
                tation exists to demonstrate proper sample identification  5. What is the concentration of the chemical in the media
                throughout the laboratory testing process? What docu-  with which the exposed population comes into contact
                mentation exists to demonstrate that the process used  (past? present? future?). What is the basis for this
                produces an accurate result—what validation processes  answer: direct measurement? modeling?
                are in place? Is the interpretation of the test results accu-  6. If the concentration is based on direct measurement,
                rate for the type of analytical test performed?    what procedures were followed in obtaining that mea-
             4. Is the testimony to be as a lay—or fact—witness?   surement? Was media sampling sufficient to ensure
             5. Is the testimony to be as an expert witness?       that it was representative? If not, why is representative-
                A. Is the expert a toxicologist?                   ness not important? Were validated analytical methods
                B. Does the scientific literature support an argument  used by an accredited laboratory? If not, how can one
                   of general causation?                           be assured that the analytical results are reliable?
                C. Was a differential diagnosis performed by the                                         46
                                                                  When considering a specific causal association:
                   laboratory?
                   1. Rule-in:
                      a. Can the expert provide reliable testimony
                         that the sample received by the laboratory
                         is representative of the diseased animals?  45. From Reference Guide on Exposure Science--Joseph V. Rodricks.
                      b. Can the expert provide reliable testimony  National Research Council. 2011. Reference Manual on Scientific
                                                                Evidence: Third Edition. Washington, DC: The National Academies
                         that the animals were in fact exposed to a
                                                                Press. doi: 10.17226/13163. See also How should the Courts Assess
                         toxic dose of the chemical in question ? To
                                                                exposure in The Admissibility of expert Testimony   Margaret A.
                         what degree of certainty does the analytical
                                                                Berger.
                         methodology demonstrate exposure of the  46. From Reference Guide on Toxicology--Bernard D. Goldstein and
                         animal to the chemical in question?    Mary Sue Henifin.National Research Council. 2011. Reference Manual
                      c. Can the expert provide reliable testimony that  on Scientific Evidence: Third Edition. Washington, DC: The National
                         the animals experienced the disease expected  Academies Press. doi: 10.17226/13163.
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