Opinion ID: 675777
Heading Depth: 1
Heading Rank: 2

Heading: admissibility of the scientific evidence

Text: 55 This case is controlled by Daubert v. Merrell Dow Pharmaceuticals, Inc., --- U.S. ----, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). As interpreted by Daubert, Rules 702 and 703 of the Federal Rules of Evidence 10 provide our analytic framework to determine whether plaintiffs presented admissible evidence in opposition to defendants' motions for summary judgment. 56 In the Daubert litigation, two minor children born with limb reduction birth defects claimed that these defects resulted from their mother's ingestion of anti-nausea prescription drug, Bendectin. 11 In support of its motion for summary judgment in the district court, defendant submitted an affidavit from a physician/epidemiologist, an expert well-credentialed on the risks of exposure to various chemical substances. Having reviewed more than thirty published studies involving 130,000 patients, none of which found Bendectin to be a human teratogen, defendant's expert concluded that maternal use of Bendectin during the first trimester of pregnancy has not been shown to be a risk factor for human birth defects. --- U.S. at ----, 113 S.Ct. at 2791. Plaintiffs did not challenge defendant's characterization of the published reports, but instead presented eight of their own impressively credentialed experts. Plaintiffs' experts concluded that Bendectin does cause birth defects, based upon in vitro (test tube) and in vivo (live) animal studies, pharmacological studies comparing the chemical structure of Bendectin to the chemical structures of other substances known to cause birth defects, and the  'reanalysis'  of previously published epidemiological studies. Id. at 2791-92. 12 The district court granted defendant's motion for summary judgment. Daubert v. Merrell Dow Pharmaceuticals, Inc., 727 F.Supp. 570, 576 (S.D.Cal.1989). 57 The Ninth Circuit agreed with the district court, basing its affirmance on its adherence to the general acceptance test of the so-called Frye Rule 13 . Daubert v. Merrell Dow Pharmaceuticals, Inc., 951 F.2d 1128, 1130-31 (9th Cir.1991). Applying Frye, that court determined that plaintiffs' evidence provided insufficient foundation to permit the expert testimony on causation, relying in part on opinions of three other circuits 14 . Daubert, 951 F.2d at 1131. The Ninth Circuit also observed that plaintiffs' reanalysis of epidemiological studies did not meet the Frye standard because they had never been published and therefore had not received peer review scrutiny, and had been generated solely for use in litigation. Id. 58 The Supreme Court granted certiorari to determine the appropriate standard for admission of expert testimony. Daubert, --- U.S. at ----, 113 S.Ct. at 2792. In its decision, the Court unanimously rejected the Frye Rule, stating: 59 Given the Rules' permissive backdrop and their inclusion of a specific rule on expert testimony that does not mention 'general acceptance,' the assertion that the Rules somehow assimilated Frye is unconvincing. Frye made 'general acceptance' the exclusive test for admitting expert scientific testimony. That austere standard, absent from and incompatible with the Federal Rules of Evidence, should not be applied in federal trials. 60 Daubert, --- U.S. at ----, 113 S.Ct. at 2794 (footnote omitted). 61 Although the opinion might have ended at that point, as the dissent in Daubert noted, id. at ----, 113 S.Ct. at 2799 (Rehnquist, C.J., and Stevens, J., dissenting), the Blackmun opinion, joined by six other justices, also presented standards and goals to aid federal judges in their consideration of the admissibility of scientific evidence. Since Daubert, federal and state courts have applied Justice Blackmun's discussion to a broad range of expert testimony in considering or resolving whether to admit the expert opinion evidence. 15 62 Several propositions discussed by the Blackmun opinion in Daubert apply directly to our resolution of the admissibility issue. Initially, the Court observed: 63 That the Frye test was displaced by the Rules of Evidence does not mean, however, that the Rules themselves place no limits on the admissibility of purportedly scientific evidence. Nor is the trial judge disabled from screening such evidence. To the contrary, under the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable. 64 --- U.S. at ---- - ----, 113 S.Ct. at 2794-95 (footnote omitted) (emphasis added). In explaining the relevancy prong, the Blackmun opinion relates: 65 Rule 702 further requires that the evidence or testimony 'assist the trier of fact to understand the evidence or to determine a fact in issue.' This condition goes primarily to relevance. 'Expert testimony which does not relate to any issue in the case is not relevant and, ergo, nonhelpful.' 3 Weinstein & Berger p 702, p. 702-18. See also United States v. Downing, 753 F.2d 1224, 1242 (CA3 1985) ('An additional consideration under Rule 702--and another aspect of relevancy--is whether expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute'). The consideration has been aptly described by Judge Becker as one of 'fit.' Ibid. 'Fit' is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes. See Starrs, Frye v. United States Restructured and Revitalized: A Proposal to Amend Federal Evidence Rule 702, and 26 Jurimetrics J. 249, 258 (1986). The study of the phases of the moon, for example, may provide valid scientific 'knowledge' about whether a certain night was dark, and if darkness is a fact in issue, the knowledge will assist the trier of fact. However (absent creditable grounds supporting such a link), evidence that the moon was full on a certain night will not assist the trier of fact in determining whether an individual was unusually likely to have behaved irrationally on that night. Rule 702's 'helpfulness' standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility. 66 --- U.S. at ----, 113 S.Ct. at 2795-96. The Court continued: 67 Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a) 16 , whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue. 68 Id. at ----, 113 S.Ct. at 2796 (footnotes omitted). 69 The expert testimony proposed by plaintiffs in this case fails to qualify for admissibility as relevant. Plaintiffs produced no evidence showing or providing a reliable inference that the Shaklee alfalfa tablets taken by their parents contained any EtO residue. 70 We also need to consider the scientific validity of the submission--as put in Daubert: 71 The inquiry envisioned by Rule 702 is, we emphasize, a flexible one. Its overarching subject is the scientific validity--and thus the evidentiary relevance and reliability--of the principles that underlie a proposed submission. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate. 72 Id. at ----, 113 S.Ct. at 2797 (footnote omitted). 73 Daubert sets out a list of non-exhaustive factors relevant to, but not necessarily determinative of a district judge's determination whether the expert will testify to relevant, scientific knowledge. Id. at ----, 113 S.Ct. at 2796-97. These factors include: 74 1. Whether the theory can be and has been tested. 75 Here, neither of Dr. Lynch's potential causal mechanisms, a germ line mutation, or a multi-factorial induced phenomenon, App. at 1247-48, or Dr. Severin's theory of a point mutation, id. at 1299-1300, due to the ingestion of EtO residue, have been studied. While plaintiffs' experts understandably state that conducting such a study on humans would be unethical, they fail to address the absence of animal studies demonstrating the incidence of EtO-sterilized food products and mental retardation. 17 76 2. Whether the theory has been subjected to peer review and publication. 77 Plaintiffs' experts have not subjected their theories to peer review 18 or publication. 78 3. As to a particular scientific technique, the court should consider the known rate of error. 79 This principle does not apply here because the testimony advanced involved theories and not any particular technique. 80 4. Generally, acceptance can yet have a bearing on the inquiry. 81 No evidence has been presented of any general acceptance of either the theory or methodology presented by the plaintiffs' experts. 82 Here, the hypotheses presented by plaintiffs' experts follow no scientific principles. Those opinions reason that, because Kristofer and Katrina sustained birth defects (mental retardation) and their parents used Shaklee's alfalfa tablets, and because some alfalfa tablets had contained an EtO residue, the parents must have ingested the EtO residue tablets. That inference turns scientific analysis on its head. Instead of reasoning from known facts to reach a conclusion, the experts here reasoned from an end result in order to hypothesize what needed to be known but what was not. 83 While it may be that this sort of reasoning could pass muster in some cases where the obvious result explains the etiology (for example, where a fractured bone accompanied by bruised outer skin and flesh demonstrate that some type of physical contact caused the injury) such reasoning cannot apply here where several possible causes could have produced one effect. As the district court noted: 84 Furthermore, Lynch also has made several assumptions that are not supported in the record (e.g., that plaintiffs' parents were not exposed to any other substances which have the ability to produce mutagenic or teratogenic effects; that no other agent containing ETO, such as Laura's cigarette smoking, could be a cause; and that the tablets plaintiffs' parents ingested contained ETO or ECH, and at sufficient levels to be mutagenic or teratogenic). Therefore, Lynch's process or technique is subject to great potential for error. 85 Dist.Ct.Op. at 10. 86 The Seventh Circuit dealt with a somewhat similar scientific inference in O'Conner v. Commonwealth Edison Co., 13 F.3d 1090 (7th Cir.1994). There the plaintiff's medical expert opined that plaintiff's cataracts had been caused by overexposure to radiation from defendants' nuclear power plant. The opinion rested on the expert's observation and opinion, but otherwise was unsupported by any scientific methodology. None of the scientific articles cited by the witness indicate that radiation-induced cataracts can be identified by mere observation. In rejecting the testimony, the court added: 87 He has not produced any personal study or experiments that otherwise would justify his conclusions that Mr. O'Conner's cataracts are radiation-induced. Indeed, his familiarity with the effects of radiation generally is limited. Dr. Scheribel's opinion has no scientific basis and, consequently, the district court correctly ruled that Dr. Scheribel's testimony is inadmissible. 88 Id. at 1107 (footnotes omitted). 89 A similar result was obtained in Porter v. Whitehall Laboratories, Inc., 9 F.3d 607 (7th Cir.1993), which involved a product liability action for damages allegedly caused by ingesting ibuprofen. Plaintiff, while awaiting surgery on a toe he injured at work, received samples of Motrin, a prescription form of ibuprofen, and Vicoden, a form of acetaminophen, from his internist's nurse practitioner. Plaintiff took the Motrin, as well as over-the-counter strength ibuprofen, for pain relief. Subsequently plaintiff returned to his internist's office, experiencing kidney failure that required a transplant. The experts provided two theories to explain plaintiff's kidney failure: (1) rapidly progressive glomerulonephritis (RPGN), due to anti-glomerular basement membrane glomerulonephritis (anti-GBM), or (2) unspecified RPGN, either caused by the process of anti-GBM or membranoproliferative glomerulonephritis (MPGN). Applying Daubert, the Seventh Circuit affirmed the district court's grant of summary judgment in favor of the defendant pharmaceutical companies, holding that the expert testimony was properly excluded for lack of grounding in the scientific method. Porter, 9 F.3d at 614. 90 In this case the district court made pertinent observations that the plaintiffs' experts addressed none of the considerations relating to scientific validity. The testimony proffered by plaintiffs was not derived from the application of any reliable methodology or principle. Despite plaintiffs' protestations to the contrary, we conclude that the district court properly held the testimony inadmissible irrespective of the experts' conclusions. 91 Daubert does not require proof with certainty. It does require that expert testimony be relevant and reliable. --- U.S. at ----, 113 S.Ct. at 2795. We note two cases, one clearly in the scientific area, the other in the general area of expert evidence, which illustrate difficult admissibility questions under the rubric of Daubert. 92 In Cantrell v. GAF Corporation, 999 F.2d 1007 (6th Cir.1993), plaintiffs presented expert testimony that their injuries (both had asbestosis and Cantrell had laryngeal cancer as well) resulted from exposure to asbestos. The expert based his opinion on examination of the plaintiffs, previous diagnoses of three individuals with laryngeal cancer out of 150 workers at the same plant (where in the general population the incidence rate is about 4 per 100,000 individuals per year) and that, in regard to Cantrell, the combination of his cigarette smoking and asbestos exposure worked in a synergistic fashion. The Sixth Circuit majority upheld the admission of plaintiffs' expert testimony, concluding that Rules 702 and 703 and Daubert do not prohibit an expert from testifying to confirmatory data, gained through his own clinical experience, on the origin of a disease or the consequences of exposure to certain conditions. Cantrell, 999 F.2d at 1014. Reluctantly Judge Wellford concurred, though he considered plaintiffs' expert's testimony erroneously admitted as challenged. Plaintiffs' expert testified 93 about the highly unusual incidence (in [the expert's] opinion) of laryngeal cancer among workers at the Lockland facility, which presented (to him) stark, striking evidence. This was akin to permitting a witness to give expert testimony against a railroad that a railroad crossing was dangerous and risky because he knew about two or three prior accidents at that location and this was highly unusual. 94 Id. at 1019. 95 In Robinson v. Missouri Pacific Railroad Company, 16 F.3d 1083 (10th Cir.1994), the Tenth Circuit upheld the district court's discretionary admission, solely for illustrative purposes, of an accidentologist's testimony as to the probable position of a vehicle and train at the moment of collision at a railroad crossing. The Tenth Circuit also upheld the district court's decision permitting the accidentologist to present a videotape of a model train and automobile colliding. The opinion commented on the limited objection made to the testimony under Fed.R.Evid. 403, observing that trial judges should carefully and meticulously examine proposed animation evidence for proper foundation, relevancy and the potential for undue prejudice. 16 F.3d at 1088. In heeding the import of Daubert, the court further observed that while the physical phenomena of crash movements may be explained on scientific principles[,] offering an opinion that a car struck at an angle will necessarily leave the railroad tracks on impact may fall outside the realm of scientific knowledge. Id. at 1089. 96 The application of Daubert to difficult admissibility questions concerning expert testimony, such as those illustrated by the above cases, remains subject to development in the courts. 97 Finally, the Daubert opinion reminds district judges that when necessary they may themselves seek expert assistance in their gatekeeper functions by resorting to Rule 706 which allows the court at its discretion to procure the assistance of an expert of its own choosing. --- U.S. at ----, 113 S.Ct. at 2798.