In re Breast Implant Litigation, 96-S-9260.

• Decision Date: 03 June 1998
• Docket Number: No. 96-S-9260.,96-S-9260.
• Citation: 11 F.Supp.2d 1217
• Parties: In re BREAST IMPLANT LITIGATION.
• Court: U.S. District Court — District of Colorado

11 F.Supp.2d 1217

In re BREAST IMPLANT LITIGATION.

No. 96-S-9260.

United States District Court, D. Colorado.

June 3, 1998.

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Patricia Jo Stone, Stone & Associates, P.C., Denver, CO, for plaintiffs.

Mary A. Wells, Wells, Anderson & Race LLC, Denver, CO, Russell O. Stewart, Faegre & Benson, Denver, CO, Joel W. Cantrick, Pendleton, Friedberg, Wilson, Hennessey & Meyer, P.C., Denver, CO, Robert Spencer, Montgomery Little & McGrew, Englewood, CO, for defendants.

MEMORANDUM OPINION AND ORDER

SPARR, District Judge.

Currently pending in this court are numerous silicone breast implant cases brought against various breast implant manufacturers. Plaintiffs seek damages for injuries they allege to have suffered from their silicone breast implants. Making claims under Colorado law for strict liability, negligence, and breach of warranty, Plaintiffs allege that their silicone breast prostheses have caused "auto-immune diseases" and have injured the Plaintiffs "in and about their body and extremities." As of this date, only the Plaintiffs in Roberts v. Baxter, Civil Action No. 91-S-923 and Zelinger v. Baxter, Civil Action No. 93-S-2762 have filed their designations of expert witnesses.

Numerous motions challenge the relevance and scientific reliability of the proffered testimony of the Plaintiffs' expert witnesses regarding a causal connection between silicone gel breast implants and "auto-immune" or systemic diseases. The expert witnesses proffered by Plaintiffs Roberts and Zelinger are Dr. Stuart S. Kassan, M.D.; Dr. Jack Klapper, M.D.; Dr. Daniel Hoffman, M.D.; Dr. Robert Guidoin, Ph.D.; and Dr. Pierre Blais, Ph.D. This opinion addresses the following motions made by Defendants Baxter Healthcare Corporation, Minnesota Mining and Manufacturing Co., Bristol-Myers Squibb Co., Natural Y Surgical Specialties, Inc., Medical Engineering Corp., Surgitek, Inc., and Aesthetech Corp. (hereinafter "Defendants"):

(1) the Defendants' Motion to Exclude General Causation Testimony and Brief in Support (Science Brief (filed June 2, 1997));

(2) the Defendants' Motion In Limine to Exclude Expert Testimony of Stuart Kassan, M.D. (filed June 2, 1997);

(3) the Defendants' Motion In Limine to Exclude Expert Testimony of Jack A. Klapper, M.D. (filed June 2, 1997);

(4) the Defendants' Motion In Limine to Exclude Expert Testimony of Daniel Hoffman, M.D. (filed June 2, 1997);

(5) the Defendants' Motion In Limine to Exclude Expert Testimony of Robert Guidoin, Ph.D. (filed June 2, 1997); and

(6) the Defendants' Motion In Limine to Exclude Expert Testimony of Pierre Blais, Ph.D. (filed June 2, 1997).¹

The court has reviewed, inter alia, the motions, Plaintiffs' Brief in Opposition (filed July 15, 1997), Defendants' Reply Brief (filed August 8, 1997), the experts' reports, the voluminous exhibits, affidavits, scientific studies, and scientific articles, the parties' proposed findings of fact and conclusions of law (filed September 29, 1997), the supplemental deposition excerpt (filed September 29, 1997), Plaintiffs' seven notebooks of scientific studies (submitted September 8, 1997); Plaintiffs' Summary of Science Articles (filed October 1, 1997), Defendants' Response to Plaintiffs' Summary of Science Articles (filed October 15, 1997), Defendants' Supplemental Brief (filed January 21, 1998), Plaintiffs' Supplemental Brief (filed January 30, 1998), Plaintiffs' supplement (filed February 25, 1998), Defendants' Response (filed March 3, 1998), Defendants' supplement (filed March 11, 1998), Defendants' supplement (filed March 12, 1998), Defendants' supplement (filed May 1, 1998), Defendant's supplement (filed May 5, 1998), the entire case file, and the applicable law and is sufficiently advised in the premises.

I. Standard of Review

The Federal Rules of Evidence govern the admission of expert scientific testimony in a federal trial.² Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Fed. R.Civ.P. 702, governing expert testimony, provides:

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.

Under the Rules, federal trial judges "must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." Daubert, 509 U.S. at 589, 113 S.Ct. 2786. The Plaintiffs have the burden of proving that the testimony of their expert witnesses is admissible pursuant to Fed. R.Evid. 702 and the standards set forth in Daubert, 509 U.S. at 579, 113 S.Ct. 2786, governing the admissibility of scientific evidence. Daubert, 43 F.3d 1311, 1316 (9th Cir.1995).

In applying Rule 702, the trial court has the responsibility of acting as a gatekeeper. Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786. "Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a), 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." Daubert, 509 U.S. at 592, 113 S.Ct. 2786. "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." Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786. "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...." General Electric Co. v. Joiner, ___ U.S. ___, ___, 118 S.Ct. 512, 520, 139 L.Ed.2d 508 (1997) (Breyer, J., concurring).

Under the first prong of the Daubert test for admissibility of expert testimony, "[t]he adjective `scientific' implies a grounding in the methods and procedures of science. Similarly, the word `knowledge' connotes more than subjective belief or unsupported speculation." Daubert, 509 U.S. at 590, 113 S.Ct. 2786. The trial court's obligation under Rule 702 and Daubert is to determine evidentiary reliability, that is, trustworthiness. 509 U.S. at 590 n. 9, 113 S.Ct. 2786. "In a case involving scientific evidence, evidentiary reliability will be based on scientific validity." Daubert, 509 U.S. at 590 n. 9, 113 S.Ct. 2786. "[I]n order to qualify as `scientific knowledge,' an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validation — i.e., `good grounds,' based on what is known. In short, the requirement that an expert's testimony pertain to `scientific knowledge' establishes a standard of evidentiary reliability." Daubert, 509 U.S. at 590, 113 S.Ct. 2786; accord Summers v. Missouri Pacific Railroad System, 132 F.3d 599, 603 (10th Cir.1997).

[T]here are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly. The scientific project is advanced by broad and wide-ranging consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably wrong are of little use, however, in the project of reaching a quick, final, and binding legal judgment — often of great consequence — about a particular set of events in the past. We recognize that, in practice, a gatekeeping role for the judge, no matter how flexible, inevitably on occasion will prevent the jury from learning of authentic insights and innovations. That, nevertheless, is the balance that is struck by Rules of Evidence designed not for the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes.

Daubert, 509 U.S. at 596-97, 113 S.Ct. 2786.

The Supreme Court has provided some guidance for the task of determining scientific validity. Daubert sets forth several non-exhaustive factors to assist trial courts in determining whether a theory or technique constitutes "scientific knowledge" within the meaning of Rule 702, including whether the methodology, principles and reasoning underlying the proposed experts' opinions: (1) can be and have been empirically tested; (2) have been subjected to peer review and publication; (3) have a known or potential rate of error; and (4) have gained general acceptance in the relevant scientific community. 509 U.S. at 593-594, 113 S.Ct. 2786.

Rule 702's second prong concerns relevancy, or "fit." Daubert, 509 U.S. at 591, 113 S.Ct. 2786. "[T]he scientific knowledge must be connected to the question at issue." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 745 (3d Cir.1994), cert. denied sub nom., General Electric Company v. Ingram, 513 U.S. 1190, 115 S.Ct. 1253, 131 L.Ed.2d 134 (1995). The trial 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 1315.³ "[T]he standard for fit is higher than bare relevance." In re Paoli, 35 F.3d at 745. Scientific expert testimony introduces special dangers to the fact-finding process because it "can be both powerful and quite misleading because of the difficulty in evaluating it." Daubert, 509 U.S. at 595, 113 S.Ct. 2786 (internal quotation marks and citation omitted). Therefore, federal judges must exclude proffered scientific evidence under Rule 702 unless they are convinced that it speaks clearly and directly to an issue in dispute in the case, and that it will not mislead the jury. Daubert, 43 F.3d at 1321.

The trial court must also look to Fed. R.Civ.P. 703 in determining the...