Allison/2

Date: Mon, 23 Aug 1999 12:10:01 EDT

3M/McGhan fraudulently induced Weiss to act in some manner on which she relied. Additionally, Allison cannot show direct detrimental reliance because she stated she never saw or read a package insert before her surgery. (Allison Dep. at 208-09.) The package insert itself does not describe the implants as "safe," but states that "augmentation mammoplasty is considered to be one of the most satisfying procedures, " before describing the various risks, including capsular contracture and leakage. Appellees' Br. at 67 (citing R. 61, App. 44.)) Because Allison was unable to show any direct or indirect detrimental reliance on representations by 3M/McGhan, her fraud/misrepresentation claims must fail, as the district court correctly found.

The district court dismissed the fraud count because Allison failed to plead with particularity as required by Federal Rule of Civil Procedure 9(b). The Eleventh Circuit has held that "where a more carefully drafted complaint might state a claim, a plaintiff must be given at least one chance to amend the complaint before the district court dismisses the action with prejudice." Bank v. Pitt, 928 F.2d 1108, 1112 (11th Cir. 1991). Allison, upon remand to the district court, relied on the pleading in the "Amended Master Complaint" in the multidistrict proceedings which stated, "Defendants made misrepresentations to plaintiff that induced her to act to her detriment and are liable to her for their fraud." 3M/McGhan and other defendants filed a "Master Answer" that raised the insufficient particularity of the fraud allegations as an affirmative defense The transferee court, noting the shortcomings of the truncated fraud pleading, stated that "an amended complaint may be required before a case is scheduled for trial,"but directed that"amendments prior to that time should generally be avoided." (Appellant's Br. at 50 (citing R. 61, App. 37.)) At no time did Allison amend her complaint. She now complains that the district court's summary judgment is an abuse of discretion because she merely followed the transferee court's instructions, that 3M/McGhan never sought a more definite statement, and that she should be given a renewed opportunity to plead under the doctrine of Bank.

The transferee court's order stated that an amended complaint may be required before a case is scheduled for trial. Certainly, when an opposing party has filed for summary judgment based on a failure to plead with particularity three weeks before the scheduled trial date, the time is ripe. Despite the instructions of the transferee court, litigants cannot cast on the district court the burden of prodding them into filing appropriate pleadings. 3M/McGhan clearly raised indefiniteness as an issue in its affirmative defense in its Master Answer adopted by the court. (Id. at n.17.) Thus, Allison's claim that 3M/McGhan never sought a more definite statement is contrary to the record.

Finally, Bank allows the plaintiff to make a more definite statement "where a more carefully drafted complaint might state a claim " 928 F.2d at 1112. Because Allison's bare bones fraud allegation requires the same proof of detrimental reliance as the misrepresentation claim, which she was unable to substantiate, the fraud claim must fail as well, regardless of any added particularity. Consequently, we find that the district court correctly granted summary judgment denying the fraud/misrepresentation claims.C. Daubert Motions

The Court next examines the exclusion of Allison's expert witnesses. Allison submitted proposed testimony by three experts to prove causation. Dr. Eric Gershwin is a board certified immunologist, Dr. Douglas Shanklin is a board certified pathologist and Dr. Sam Schatten was Allison's treating board certified rheumatologist. Federal Rule 104(a) provides:

Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court, subject to the provisions of subdivision (b). In making its determination it is not bound by the rules of evidence except those with respect to privileges. Under Rule 104(a) the parties submitted hundreds of scientific studies and journal articles for the district court to examine. In addition, accompanying affidavits and depositions were submitted and were before the court during the three day Daubert hearing. We note at the outset, despite 3M/McGhan's bandying about of terms such as "junk science" and "science for hire," that the district court was careful to note the impeccable qualifications of the experts it was reviewing and that the court had before it sufficient record to adequately assess the Daubert issues. See City of Tuscaloosa v. Harcros Chem., Inc., 158 F.3d 548, 565 & n.21 (11th Cir. 1998) (finding an abuse of discretion when the court fails to conduct a suitable inquiry into the relevant factors to determine whether expert testimony should be admitted), reh'g denied, 172 F.3d 884 (11th Cir. 1999).

1. The Daubert Standard

The district court properly set out the standard enunciated in Daubert and its progeny, noting its interaction with other pertinent rules of evidence. Summarizing the applicable rules of admissibility of scientific evidence, this Court in City of Tuscaloosa, 158 F.3d at 562, stated that scientific expert testimony is admissible when (1) the expert is qualified to testify competently regarding the matters he intends to address; (2) the methodology by which the expert reaches his conclusion is sufficiently reliable as determined by the sort of inquiry mandated in Daubert; and (3) the testimony assists the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue.

The Daubert analysis does not operate in a vacuum. Any proffer of scientific evidence is also subject to other rules of evidence. 3M/McGhan therefore challenged Allison's expert testimony on the basis of Rules 401, 402, 403, 702 and 703. a. Rules 401, 402 and 403 Federal Rules 401 and 402 deal with the admissibility of relevant evidence. Rule 402 allows the admission of all relevant evidence "except as otherwise provided by the Constitution of the United States, by Act of Congress, by these rules, or by other rules prescribed by the Supreme Court pursuant to statutory authority. Evidence which is not relevant is not admissible." Rule 401 defines "relevant evidence" as that which has "any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence."

3M/McGhan challenged the expert evidence on the basis of Rule 403 as well. While the district court only mentions this rule as one of the bases that 3M/McGhan offers for exclusion, it apparently indirectly entered the court's consideration. Rule 403 states, "Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence." The Supreme Court recognized in Daubert the intricate role of Rule 403 in an expert testimony admissibility analysis when it noted that expert testimony could be "both powerful and quite misleading because of the difficulty in evaluating it." 509 U.S. at 595 (quoting Weinstein, Rule 702 of the Federal Rules of Evidence is Sound; It Should Not Be Amended, 138 F.R.D 631 (1991)); see also Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1407 n.43 (D. Or. 1996) (finding a Rule 403 analysis applicable but unnecessary in making its decision to exclude testimony).

Thus, while Rules 401 and 402 reflect the general policy of the Federal Rules for liberal admission of evidence, Rule 403, working in conjunction with Rules 702 and 703, militates against this general policy by giving courts discretion to preclude expert testimony unless it passes more stringent standards of reliability and relevance. These stricter standards are necessary because of the potential impact on the jury of expert testimony. While the district court did not expressly exclude any testimony on the basis of Rule 403, we note that its consideration would only serve to buttress the court's ultimate exclusion of the proffered experts. b. Rule 702 and Daubert's Requirements of Reliability and Relevance

Federal Rule of Evidence 702 states, "If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise." The Supreme Court imposed a special gatekeeping role on the trial judge in Daubert, 509 U.S. at 597, to ensure that scientific evidence is both reliable and relevant before being admitted as evidence. The Supreme Court later acknowledged the difficulty of this role when it stated, "Neither the difficulty of the task nor any comparative lack of expertise can excuse the judge from exercising the ‘gatekeeper' duties that the Federal Rules impose."Joiner, 522 U.S. at 148 (Breyer, J., concurring) (noting also that judges are not trained scientists). The Court opined that scientific knowledge is far afield from the normal expertise of judges and that they should proceed with caution lest they exceed their grasp. Daubert, 509 U.S. at 599 (Rehnquist, J., and Stevens, J., concurring in part and dissenting in part).

While meticulous Daubert inquiries may bring judges under criticism for donning white coats and making determinations that are outside their field of expertise, the Supreme Court has obviously deemed this less objectionable than dumping a barrage of questionable scientific evidence on a jury, who would likely be even less equipped than the judge to make reliability and relevance determinations and more likely than the judge to be awestruck by the expert's mystique. Also, a judge may enlist outside experts to assist in this sometimes very difficult decision. Using independent court-appointed experts may serve to quell the pseudo-scientist criticism.

Some judges, noting the general complexity of some expert evidence and in the penultimate exercise of caution and conscience, have exercised their inherent authority to use outside experts and have engaged in elaborate Daubert inquiries in an effort to sort out conflicting scientific opinions in a comprehensive search for reliability and relevance. Judge Sam C. Pointer, the multidistrict transferee judge for federal breast implant cases, commissioned the National Science Panel ("NSP") under Rule 706 to consider the scientific evidence on whether silicone breast implants cause systemic disease. The NSP is considered a prototype investigative panel allowing the court to escape the heated rhetoric of the courtroom and obtain a more dispassioned analytical look at the scientific evidence with the assistance of neutral scientific experts. United States District Judge Robert E. Jones in Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996), conducted an extensive Daubert hearing by using court-appointed technical advisors under Rule 104 to help evaluate the "reliability and relevance" of the scientific evidence in seventy cases brought against implant makers. Because of the painstaking analyses which district courts undertake in making these admissibility determinations, their efforts are well deserving of the deference that the Supreme Court has accorded through the abuse of discretion standard enunciated in Joiner. While some courts on occasion use evidentiary findings of other courts as precedent when reviewing essentially the same factual issues in their Daubert decisions, the district court here did not use other breast implant causation precedents in making its decision. See Daubert, 43 F.3d at 1322 n.19 (noting on remand findings of other circuits denying admissibility of expert testimony on the issue of Bendectin causation of limb reduction). Nor do we depend on the conclusions of other courts regarding causation of systemic disease in breast implant recipients as precedent for affirming the decision of the district court. We merely note in passing that other courts, after thoroughly sifting through the scientific data, have come to the same decision, and indeed have even excluded some of the same experts as the district court did here in the execution of its gatekeeping role (an indication that the district court was not operating on the outer fringe of its discretion).

The gatekeeper role, however, is not intended to supplant the adversary system or the role of the jury: "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Daubert, 509 U.S. at 596. The judge's role is to keep unreliable and irrelevant information from the jury because of its inability to assist in factual determinations, its potential to create confusion, and its lack of probative value.

(1) The Reliability Prong

The Daubert Court listed four noninclusive factors courts should consider in determining reliability under Rule 702: (1) whether the theory or technique can be tested; (2) whether it has been subjected to peer review; (3) whether the technique has a high known or potential rate of error; and (4) whether the theory has attained general acceptance within the scientific community. Id., 509 U.S. at 593-94. Daubert's flexible four-pronged analysis supplanted the longstanding "austere" Frye standard which allowed the admission of expert testimony when it was generally accepted in the relevant scientific community. Frye v. United States, 293 F. 1013, 1013 (D.C. Cir. 1923). While Allison argues that the thrust of the Rules and of the Eleventh Circuit has been for liberal admissibility of evidence, she fails to appreciate the tempering qualities of Rules 403, 702 and 703 under Daubert and the fact that this Circuit has been twice overruled on Daubert decisions in precedent setting Supreme Court decisions in Joiner and Kumho Tire, both of which imposed stricter admissibility standards than the Eleventh Circuit had deemed appropriate. Joiner, 522 U.S. 136; Kumho Tire Co. v. Carmichael, U.S., 119 S. Ct. 1167 (1999).

The district court, citing Daubert, properly recognized that the above four factors are not exhaustive and stated that its primary focus would "be solely on principles and methodology, not on the conclusions that they generate." Daubert, 509 U.S. at 595. Thus, the proponent of the testimony does not have the burden of proving that it is scientifically correct, but that by a preponderance of the evidence, it is reliable. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3rd Cir. 1994). The Daubert court itself recognized that the factors it listed were a mere starting point for a court's analysis. Some other factors which this and other courts have considered in the Daubert analysis are reliance on anecdotal evidence (as in case reports), temporal proximity, and improper extrapolation (as in animal studies). Willert v. Ortho Pharm. Corp., 995 F. Supp. 979, 981-82 (D. Minn. 1998); National Bank of Commerce v. Dow Chem. Co., 965 F. Supp. 1490, 1504-05 (E.D. Ark. 1996).

(2) The Relevance Prong

Under the second prong of Daubert, the relevance requirement, the court must "ensure that the proposed expert testimony is ‘relevant to the task at hand,' i.e., that it logically advances a material aspect of the proposing party's case." Daubert, 43 F.3d at 1315 (on remand). Thus, the evidence must have a valid scientific connection to the disputed facts in the case. Daubert, 509 U.S. at 591 (holding "scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes.Rule 702's ‘helpfulness' standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility"). This connection has been appropriately denominated as "fit." Id. c. Rule 703

Finally, 3M/McGhan challenges Allison's expert testimony on the basis of Rule 703 which states:

The facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to the expert at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence.