Opinion ID: 774843
Heading Depth: 2
Heading Rank: 2

Heading: Exclusion of Metabolife's Scientific Evidence

Text: 25 Metabolife could not meet its burden on falsity below after the district court excluded all of its scientific evidence regarding the safety of Metabolife 356 when used as directed. Under the anti-SLAPP statute, a plaintiff must meet its burden of proving prima facie falsity with admissible evidence. Wilcox, 33 Cal. Rptr. 2d at 459; Evans v. Unkow, 45 Cal. Rptr. 2d 624, 628 (Cal. Ct. App. 1995). The district court held that Metabolife's scientific evidence was not admissible under Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311 (9th Cir. 1995) (Daubert II). 72 F. Supp. 2d at 1167-70.
26 Scientific evidence is admitted pursuant to Federal Rule of Evidence 702. In Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 587-89 (1993) (Daubert I), the Supreme Court held that Rule 702 displaced the prior general acceptance test. Under Daubert II, the district court acts as a gatekeeper, excluding bad science that does not carry sufficient indicia of reliability for admission under Rule 702. 43 F.3d at 1316. This is accomplished through a preliminary determination that the proffered evidence is both relevant and reliable. 12 Daubert I, 509 U.S. at 589-92. 27 Scientific evidence is reliable if it is based on an assertion that is grounded in methods of science -the focus is on principles and methodology, not conclusions. Id. at 595-96. The Supreme Court listed four non-exclusive factors for consideration in the reliability analysis: (1) whether the scientific theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether a particular technique has a known potential rate of error; and (4) whether the theory or technique is generally accepted in the relevant scientific community. Id. at 593-94. 28 In Daubert II we noted that a very significant fact to be considered is whether the experts are proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying. 43 F.3d at 1317. If the evidence is not based upon independent research, the district court must determine whether there exists any other objective, verifiable evidence that the testimony is based on scientifically valid principles. Id. at 1317-18 (internal quotation marks omitted). Peer review is the chief way of satisfying this requirement, though it may also be met by 29 precisely [explaining] how [the experts ] went about reaching their conclusions and point[ing] to some objective source -a learned treatise, the policy statement of a professional association, a published article in a reputable scientific journal or the like -to show that they have followed the scientific method, as it is practiced by (at least) a recognized minority of scientists in their field. 30 Id. at 1318-19 (citing United States v. Rincon, 28 F.3d 921, 924 (9th Cir. 1994)).
31 Metabolife presented scientific evidence through the declarations of six experts and the results of scientific research. Five of the experts presented opinions based onscientific risk assessment. 13 . The sixth expert, Dr. Ruth Hammel Strauss, interpreted the results of an unpublished cardiovascular risk study that she conducted at Columbia Medical Center. Besides the Columbia study, the results of two other research projects were also submitted to the district court: (1) animal toxicity tests conducted at Shanghai Medical University and National Taiwan University and (2) short-term efficacy studies at Vanderbilt University Medical Center and St. Luke's-Roosevelt Hospital Center. 32 After noting that, with the exception of Dr. Strauss's, all of the opinions expressed in the declarations were prepared for the purpose of litigation, the court dismissed thescientific risk assessments because it found the underlying sources unreliable and the explanation of methodology lacking. 72 F. Supp. 2d at 1167-70. The district court also found the Asian animal studies, Dr. Strauss's interpretation of the Columbia study, and the efficacy studies too unreliable to be admitted. Id. 33
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
43 The district court found the Columbia cardiovascular study unreliable because (1) it was commissioned by Metabolife, (2) it was not completely finished, and (3) the part that was finished had not been subjected to peer review. 72 F. Supp. 2d at 1169-70. Metabolife argues that the relevant portion of the study was completed with the data in final form, the research was begun pre-litigation, and Dr. Strauss's declaration provides a detailed description of the methodology that she used. 44 Excluding the Columbia study was an abuse of discretion. It was plain error to hold that the Columbia study was not finished -while the overall project was ongoing, all of the relevant data had been gathered in final form, and Metabolife presented an expert interpretation of that data. We remand the issue of reliability to the district court. As explained above, when research is begun pre-litigation, it may be reliable without peer review. Daubert II, 43 F.3d at 1317. Rather than disqualify the study because of incompleteness or because it was commissioned by Metabolife, the district court should examine the soundness of the methodology employed. 45 The district court also noted in dicta that the Columbia study is of questionable relevancy to the falsity of the statement you can die from taking this product as directed because the study dealt only with particular cardiovascular effects, and there are more ways to die than through `significant adverse cardiovascular events' . . . . This logic is difficult to follow given that the main health risk allegedly associated with Metabolife 356 is its effect as a stimulant on the cardiovascular system. 46
47 An efficacy study is a study that determines whether Metabolife 356 actually helps people lose weight. It is not designed, at least primarily, to be a safety study. Because of this, the district court held that the efficacy studies are not reliable research methodology for testing the safety of a supplement intended for long-term use. Safety testing is not even the purpose of the study's research design. 72 F. Supp. 2d at 1170. While we decline to create a per se rule about what safety information can be reliably gleaned from efficacy studies, we agree with the district court that any such data generated by the studies at issue in this case lacks sufficient grounding in the scientific method to be admissible under Daubert II. 48
49 Risk assessment is an accepted methodology practiced extensively throughout the medical, scientific, and regulatory communities over the past thirty years. See Bernard Goldstein & Mary Sue Henifen, Reference Guide on Toxicology in Federal Judicial Center Reference Manual on Scientific Evidence 193 (1994). Standard risk assessment involves four stages: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Id. Metabolife argues that consistent with this methodology, its experts consulted a wealth of peer-reviewed articles, Food and Drug Administration adverse incident reports, 15 studies, laboratory reports, and other scientific materials to formulate their opinions. 50 The district court rejected the experts' risk assessments because they did not explain precisely how they use[d] the scientific literature to support their opinion[s]. Rather, the experts list[ed] numerous articles in scientific journals and simply state[d] that, after reviewing these articles [and other information], they [were] convinced that Metabolife 356 cannot cause serious health problems. 72 F. Supp. 2d at 1170. The district court was troubled by the titles of several articles cited, noting that it did not understand how articles such as these support the opinions of Metabolife's experts. . . . Id. 51 Metabolife contends that the district court's ruling was an abuse of discretion, arguing that since the articles referred to were in peer-reviewed journals, the experts were not required to explain specifically how each article impacted their opinion. In Metabolife's view, the explanation requirement only arises when there is an absence of peer-reviewed literature directly supporting the position held by the expert. 52 Neither the district court's nor Metabolife's application of the Daubert II requirements in entirely correct. Metabolife is correct that peer-review is highly probative under Daubert II, 43 F.3d at 1318-19, but here the articles were not written by the experts who now wish to interpret them. Metabolife's experts, through risk assessment methodology, are interpreting peer-reviewed articles written by other scientists. The district court, as gatekeeper, correctly noted that the methodology of their interpretation should be open to scrutiny. 53 However, the district court abused its discretion in its summary decision that the risk assessments were not adequately explained. 72 F. Supp. 2d at 1170. In Daubert II, we said that scientific evidence, such as a risk assessment, that is prepared for litigation and not peer-reviewed itself, may be bolstered through the testimony of . . . [the ] experts who prepared the evidence. 43 F.3d at 1319. For such a showing to be sufficient, the experts must explain precisely how they went about reaching their conclusions and point to some objective source . . . to show that they have followed the scientific method. . . . Id. 54 Here, Metabolife's experts explained the process of risk assessment and pointed to objective sources, but did not, in the district court's view, adequately explain how those objective sources related to their methodologies and eventual conclusions. We agree with the district court that the risk assessment evidence is complex, but complexity is not an adequate ground for exclusion. Examining the declarations of the scientists who prepared the risk assessments, it is clear that they have facially complied with Daubert II's verification requirement for evidence prepared in anticipation of litigation -the declarations explain the methodology of risk assessment and how the data found in peer-reviewed articles and adverse incident reports was used. See 43 F.3d at 1318-19. 55 However, due to the complexity of this evidence and our deferential role in reviewing the admissibility of scientific evidence, we are not prepared to override the district court's role as gatekeeper and hold that the risk assessment evidence is admissible. Rather, we simply hold that the wholly conclusory grounds for exclusion listed by the district court constitute an abuse of discretion. If on remand the district court wishes to plumb the depths of the precise relationship between the materials cited and the conclusions drawn, that is entirely within its province as a Daubert II gatekeeper.