Opinion ID: 774843
Heading Depth: 4
Heading Rank: 1

Heading: The Asian Animal Studies

Text: 34 The district court held that, as a matter of law, animal studies are inadmissible due to the uncertainties in extrapolating from effects on mice and rats to humans. Id. at 1169. The district court was also troubled because the animal studies took place outside the United States government's regulatory supervision. Id. 35 The district court's ruling was incorrect. First, Daubert II itself recognized that animal studies are not per se inadmissible and should be subjected to substantive analysis, just like other scientific evidence. 43 F.3d at 1319 (conducting substantive analysis of animal studies). The cases cited by the district court in support of its per se rule -Turpin v. Merrell Dow Pharms., Inc., 959 F.2d 1349 (6th Cir. 1992), Lynch v. Merrell-Nat'l Lab., Div. of Richardson-Merrell, Inc. , 830 F.2d 1190 (1st Cir. 1987), and In re Agent Orange Prod. Liab. Lit., 611 F. Supp. 1223 (E.D. N.Y. 1985) -are all preDaubert. 72 F. Supp. 2d at 1169. Beyond that, they are inapposite. 36 Turpin and Lynch were products of the Bendectine birthdefects litigation. These cases merely hold that, in predicting birth defects, the developmental patterns of different species are too different to allow for the presence or absence of a birth defect in one species to be reliable evidence of the likelihood of such a birth defect occurring in another species. Both cases are limited to birth defects; Turpin even notes, No doubt there may be other animal experiments which, to cite one example, because of the extreme toxicity of the substance tested, would permit a reasonable jury to find that it is more probable than not that the substance causes a similar harm to humans. 959 F.2d at 1359. 37 The other case, In re Agent Orange, cites a study for the proposition that [a]nimal studies are aimed at discovering a dose-response relationship, while epidemiological studies show an association between exposure and disease  and concludes that, because of the unique facts of that case, [t]he animal studies are not helpful in the instant case. . . . 611 F. Supp. at 1241. Again, the case neither creates nor applies a general rule of unreliability. 38 None of these cases holds that animal studies will always be too unreliable to provide admissible evidence about human health issues. Notwithstanding the moral and ethical problems often surrounding animal studies, in some circumstances they provide useful data about human health. 14 The district court erred in rejecting the animal studies proffered by Metabolife merely because of the species gap. 39 Also wrong is the district court's view that experimentation outside the United States is somehow presumptively unreliable. While regulation of experimentation in the United States may bolster the reliability of results generated domestically, there is no reason to assume that experimentation abroad either would not meet those regulations or is unreliable despite deviancies. 40 We note another of the district court's concerns, the difficulty in extrapolating from high-dose, short-term studies, such as the Asian animal studies, to the low-dose, long-term usage that would result from continued use of Metabolife 356 as directed. 72 F. Supp. 2d at 1169. A variance between experimental conditions and real world usage might indeed be problematic, but we do not read the district court's order as relying on this issue alone, and even if it did, it would be an abuse of discretion to exclude the studies merely because [d]ifficulties in such extrapolation has lead to controversy concerning the admissibility of such studies. Id. Difficulties with extrapolation might render the animal studies unreliable under Daubert; however, such a determination must be made on problems inherent to the studies themselves, not a general apprehension at inter-species and inter-dosage extrapolation. 41 After United States v. Alatorre, 222 F.3d 1098, 1100 (9th Cir. 2000), we are prohibited from ordering a district court to conduct pretrial hearings in order to discharge [its Daubert] gatekeeping function. Thus, we merely hold that the district court's analysis of the reliability of these studies constituted an abuse of discretion. While evidentiary hearings might help the district court to conduct an adequate Daubert analysis, [t]he trial court must have the same kind of latitude in deciding how to test an expert's reliability, and to decide whether and when special briefing or other proceedings are needed to investigate reliability, as it enjoys when it decides whether or not that expert's relevant testimony is reliable . . . . Alatorre, 222 F.3d at 1102 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 153 (1999)). 42