Allison/3

Date: Mon, 23 Aug 1999 12:10:34 EDT

(Continuing)

The Daubert Court pointed out that Rule 703 applies solely to expert opinions based on otherwise inadmissible hearsay. Id., 509 U.S. at 595. The Eleventh Circuit has alluded to another distinction to which some courts adhere, that Rule 702 governs only the scientist's "major premise" (the "principle, procedure, or explanatory theory derived by the inductive, scientific technique"), while Rule 703 addresses "the sources the expert may consult in collecting the case-specific information to serve as the minor premise." Davis v. Southern Bell Tel. & Tel. Co., (S.D. Fla. Feb. 1, 1994) (citing Edward J. Imwinkelreid, The "Bases" of Expert Testimony: The Syllogistic Structure of Scientific Testimony, 67 N.C.L. Rev. 1 (1988)). Both rules are implicated in 3M/McGhan' motions.

The district court properly outlined the above standard in its opinion, and indeed, Allison does not dispute the court's delineation of the standard. Rather, Allison takes issue with the district court's application of the standard to her proffered experts. The Court will therefore next examine whether the district court abused its discretion in applying this standard to Allison's three causation experts.

2. The testimony of Dr. Eric Gershwin

Dr. Gershwin proposed to testify that "silicone is capable of causing systemic harm in exposed women." (R. 62, Ex. 4, Gershwin Decl. at 3.) More specifically, "(a) silicone is not inert; (b) silicone can induce inflammation; (c) silicone can induce granulomas; (d) silicone migrates; (e) silicone implants can induce autoantibody production; (f) silicone is an adjuvant; (g) silicone can emulsify; and (h) agents which induce chronic inflammation and granulomas are associated with systemic complaints and disease." (Id. at 6.) Gershwin's ultimate conclusion was that in his opinion, "to a reasonable degree of medical certainty, silicone breast implants cause or exacerbate systemic conditions in some women." (Id. at 22-23.) Gershwin stated the bases of his opinion were his own research, clinical experience, peer reviewed literature on silicone as an adjuvant, the Marilyn Lightfoote study, studies examining silicone oil treatment of detached retinas, silicone related antibody studies, studies showing biomarkers in women with implants, case reports, and epidemiological (human statistical) studies.

The district court found that Gershwin's opinion was unreliable under Daubert because of improper scientific methodology, stating that Gershwin's theories had not been tested, were not subject to peer review and were not generally accepted by the scientific community. While we disagree with some of the district court's statements regarding peer review, we find it did not abuse its discretion in ruling Dr. Gershwins's testimony inadmissible.

The district court found that the five animal studies Gershwin relied on in addition to the Lightfoote study were inadequate to support the theory that silicone is an adjuvant. The court noted in passing that the Lightfoote unpublished study was not subjected to peer review. Allison establishes that Lightfoote's oral presentation was subject to the review of her peers. This fact, however, is no more helpful than peer review in other forums. As Allison and the Supreme Court point out, "Publication (which is but one element of peer review) is not a sine qua non of admissibility; it does not necessarily correlate with reliability." Daubert, 509 U.S. at 593. Peer review is significant under Daubert because "scrutiny of the scientific community is a component of ‘good science,' in part because it increases the likelihood that substantive flaws in methodology will be detected." Id. But if peer review alone was dispositive, then the Frye standard of general acceptability in the scientific community would have remained adequate. Consequently, a finding that Lightfoote's animal study was peer reviewed does not mean it constituted an adequate basis for Gershwin's opinion that silicone breast implants cause systemic disease.

The court found Gershwin failed to explain the correlation of the results of Lightfoote's rat studies in which the rats were directly injected with silicone to symptoms in a human patient where the inner lumen of the implants had remained intact. Similarly, the court found that Gershwin failed to convincingly extrapolate data from the human retinal studies to cases involving unruptured implants. The court specifically noted extrapolation or "leap" problems with Gershwin's collagen antibody studies having a causal connection to systemic disease.

Daubert decisions in other courts warn against leaping from an accepted scientific premise to an unsupported one. Moore v. Ashland Chem. Inc., 151 F.3d 269, 278-79 (5th Cir. 1998) (citing Wheat v. Pfizer, Inc., 31 F.3d 340, 343 (5th Cir.1994) (finding that physician could not show reactive airways dysfunction syndrome ("RADS") was caused in a patient when his exposure level to toluene was unknown)), cert. denied, 119 S. Ct. 1154 (1999); Braun v. Lorillard, Inc., 84 F.3d 230, 235 (7th Cir. 1996) (finding use of asbestos detection test for buildings improper for detection in human tissue); Daubert, 43 F.3d at 1319-20 (rejecting experts' opinions who relied on animal studies, chemical structure analyses, and epidemiological data when experts failed to clearly demonstrate scientific methodology); Conde v. Velsicol Chem. Corp., 24 F.3d 809, 814 (6th Cir. 1994) (finding animal studies inadequate for showing causation of disease in humans with chlordane exposure); Cavallo v. Star Enter., 892 F. Supp. 756, 769 (E.D. Va. 1995) (finding methodology of studies on toxic effects of chemicals sound but misapplied to the case at hand), rev'd in part on other grounds, 100 F.3d 1150 (4th Cir. 1996).

Allison complains that Dr. Gershwin did indeed explain the linkage between the rat studies and Ms. Allison's disease. (Appellant's Br. at 40-43.) While the district court noted the explanation, it was within its discretion to simply find it inadequate. Allison reasons that the adjuvancy papers were not published in the animal toxicology literature and were certainly not intended to provide information on how to treat arthritic rats; they were published in peer reviewed scientific journals intended to be read by clinicians and others treating real people[;] thus their relevance is established by the very books and journals in which they appeared.(Id. at 43.) We are fully confident that the district court understood that these studies were not undertaken to treat silicone exposed rats. Publication in a peer reviewed medical journal for humans, however, does not alone establish the necessary link required under Daubert. Cf. In re Paoli, 35 F.3d at 743 (explaining requirement for proper extrapolation from animal studies to show relevance). Furthermore, Allison does not explain why the results of these animal studies should trump more than twenty controlled epidemiological studies of breast implants in humans which have found no valid increased risk of autoimmune disease. See Conde, 24 F.3d 814 (finding fault with expert who neither testified to the collective view of his scientific discipline nor explained the grounds for his differences, citing Turpin v. Merrell Dow Pharm., Inc., 959 F.2d 1349, 1360 (6th Cir. 1992)).

Allison complains that the district court improperly rejected the retinal studies on the basis that no linkage was found with Allison's unruptured implants. Allison states that there was without dispute, silicone in Ms. Allison's breast tissue. Even assuming gel bleed, a finding that silicone oil emulsifies in the eye indicates that silicone gel similarly emulsifies in breast tissue and causes systemic disease is still quite a leap. As the Supreme Court pointed out in Joiner, 522 U.S. at 146-47, "[I]t was within the District Court's discretion to conclude that the studies upon which the experts relied were not sufficient, whether individually or in combination, to support their conclusions" of causation. As in Joiner, the district court, after conducting a thorough review of the medical evidence, did not abuse its discretion by finding that Dr. Gershwin failed to adequately establish the link between the animal, retinal, and anti-collagen studies and Allison's complaints of disease.

The district court next took a detailed look at the four epidemiological studies Gershwin offered to support his opinion but, in each case, the court found reasons why these studies did not supply an adequate foundation for Gershwin's causation opinion. Briefly, it found the Kayler study unreliable because it was a re-analysis of other studies that had found no statistical correlation between silicone implants and disease. It found the Friis study irrelevant because it specifically scrutinized muscular rheumatism, not systemic disease. Similarly, the Giltay study found correlations between implants and increased risk of joint pain, a complaint which Allison did not have. While the study did support Allison's claim for burning eyes, the court noted that the women participating in the study were aware of the hypothesis, a factor which could have created bias, skewing the results and ultimately making its conclusions suspect. The court found that the Hennekens study, which had the most significant statistical correlation of silicone and increased ANA, had a relative risk of only 1:24, a finding so significantly close to 1.0 that the court thought the study was not worth serious consideration for proving causation.

The court found that Gershwin's proposed four studies were in direct contrast to over twenty other epidemiological studies which found no statistical correlation between silicone breast implants and systemic disease, strong evidence that a consensus exists in the general scientific community that no correlation exists. Allison complains that the district court erred by looking at conclusions rather than methodology and principles as Daubert directed. While weighing the relative findings of the studies may seem to be a resurrection of the Frye standard (general acceptance in the scientific community), courts have noted that Daubert's suggested criteria to examine whether the theory has attained general acceptance within the scientific community, Daubert, 509 U.S. at 593-94, does just that. Joiner made it clear that although principles and methodology were the focus, the court was not precluded from looking at conclusions:

Conclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. Joiner, 522 U.S. at 146; see also Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 598 (9th Cir. 1996) (noting that a court may properly scrutinize anomalous conclusions and reject expert opinion if the expert fails to identify and defend the reasons why his scientific methodologies yielded novel results). We find that the district court did not abuse its discretion by considering that the proffered conclusions in studies with questionable methodologies were out of sync with the conclusions in the overwhelming majority of the epidemiological studies presented to the court. We additionally note that the district court lists Allison's four problematic epidemiological studies as only one of many factors for ultimately rejecting Gershwin's testimony.

Allison states that because these studies were published in peer reviewed journals, then ipso facto their methodology has been determined sound. But as mentioned supra regarding the Lightfoote study, while peer review increases the likelihood that substantive flaws in methodology will be detected, scrutiny by one's peers does not insure admissibility. Again, it is well established that "publication is not a sine qua non of admissibility." Daubert, 509 U.S. at 593.

Allison complains that the district court failed to consider Gershwin's testimony that silicone can induce chronic inflammation, and chronic inflammation is associated with systemic disease. Allison states that Dr. Gershwin's opinion in this area is basic textbook medicine, is unassailable and was excluded sub silentio by the district court. While the district court did not specifically single out Gershwin's chronic inflammation theory for comment, we do not conclude that it failed to consider the testimony. The court's global conclusions regarding Dr. Gershwin's opinions, that they were untested and that extrapolations from animal studies were inadequate, is reasonable in light of Dr. Shanklin's testimony that "pathologists generally, as well as myself, are still learning the full implications of [chronic inflammatory problems]" and that no one to his knowledge had made the "connection" in the peer reviewed literature between silicone induced chronic inflammation and systemic disease. (Shanklin Dep. vol. I at 68-71.)

Allison also states that the district court should not have found Gershwin's reliance on case studies improper methodology. While we acknowledge the importance of anecdotal studies for raising questions and comparing clinicians' findings, in the face of controlled, population-based epidemiological studies which find otherwise, these case studies pale in comparison. See Hall, 947 F. Supp. at 1411 (finding that "case reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls"; hence, they do not supply scientific knowledge upon which an opinion can be based under Daubert); Casey v. Ohio Med. Prods., 877 F. Supp. 1380, 1385 (N.D. Cal. 1995) (finding case reports do not provide reliable scientific evidence of causation). The district court did not abuse its discretion by discounting Dr. Gershwin's reliance on case reports in the face of the overwhelming contrary epidemiological evidence presented.

While the court stated that Gershwin's studies had not been subjected to peer review, this factor has bare mention in the court's analysis of Gershwin's testimony. We find, in contrast to the district court, that many of Dr. Gershwin's theories had been subjected to peer review. Dr. Gershwin is a prolific scientific author and has published numerous articles in peer reviewed journals, and he himself is a peer reviewer. (R. 33, Pl.'s.