Hall v. Baxter Healthcare Corp.

Citation947 F.Supp. 1387
Decision Date18 December 1996
Docket NumberCivil No. 94-903-JO.,Civil No. 94-258-JO.,Civil No. 92-182-JO (LEAD).,Civil No. 94-1280-JO.,Civil No. 93-589-JO (LEAD).,Civil No. 94-765-JO.,Civil No. 94-892-JO.,Civil No. 94-949-JO.,Civil No. 94-260-JO.,Civil No. 94-907-JO.,Civil No. 94-902-JO.
PartiesLeaann D. HALL, Plaintiff, v. BAXTER HEALTHCARE CORP.; et al., Defendants. Tammy JOHNSTON; Robert Johnston; Laura Bentley; Ralph Bentley; Susan Eisele; Darrell Dwayne Eisele; Michelle Tytlar; Jeffrey Tytlar, Plaintiffs, v. BRISTOL-MYERS SQUIBB COMPANY, et al., Defendants. Debra SHERVEY, Plaintiff, v. BRISTOL-MYERS SQUIBB COMPANY, et al., Defendants.
CourtU.S. District Court — District of Oregon

Keith E. Tichenor, Jeffrey S. Mutnick, Peter W. Preston, Jodie A. Phillips, Pozzi Wilson Atchison, Portland, OR, Michael L. Williams, Kathleen M. Dailey, Williams & Troutwine, P.C., Portland, OR, Don Corson, Arthur C. Johnson, Johnson Clifton Larson & Corson, Eugene, OR, Janet Adamson, John Adamson, Portland, OR, Linda K. Eyerman, Gaylord & Eyerman, Portland, OR, Leslie A. Kocher, MacMillan Scholz & Marks, Portland, OR, Diana L. Craine, Craine & Love, Lake Oswego, OR, for Plaintiffs and Plaintiffs Pro Se.

Jonathan M. Hoffman, Martin Bischoff Templeton Langslet & Hoffman, Portland, OR, Paul R. Duden, Stephen R. Frank, Eric J. Neiman, Matthew J. Mullaney, Jr., Tooze Shenker Duden Creamer Frank & Hutchison, Portland, OR, John Ostrander, Bonaparte Elliott & Ostrander, Portland, OR, Robert W. Roley, Donald H. Pyle, Lane Powell Spears & Lubersky, Portland, OR, Ronald E. Bailey, Marilyn E. Litzenberger, Jeanne F. Loftis, Bullivant Houser Bailey Pendergrass & Hoffman, Portland, OR, James H. Gidley, Crowe & Gidley, Portland, OR, Jeffrey D. Austin, William B. Crow, Miller Nash Wiener Hager & Carlsen, Portland, OR, Barbara H. Thompson, Lehner Mitchell Rodrigues & Sears, Portland, OR, Steven K. Blackhurst, Michael J. Sandmire, Ater Wynne Hewitt Dodson & Skerritt, Portland, OR, Michael C. McClinton, Clark Lindauer McClinton Krueger & Fetherston, Salem, OR, for Defendants.

OPINION AND ORDER

ROBERT E. JONES, District Judge:

I. INTRODUCTION

Currently pending in this court are a number of silicone breast implant cases brought by or on behalf of the plaintiffs against various breast implant manufacturers.1 Plaintiffs seek damages for injuries they claim to have suffered as a result of implantation with silicone gel breast implants.

Among other things, the plaintiffs assert that silicone from the implants has migrated and degraded in their bodies and has caused a systemic syndrome or illness, which they generally refer to as "atypical connective tissue disease" (ACTD). In essence, plaintiffs claim a "unique constellation of symptoms" consisting of hundreds of symptoms commonly experienced by the general population.2

This opinion addresses the defendants' motions in limine to exclude testimony by plaintiffs' experts concerning any causal link between silicone breast implants and the alleged systemic disease or syndrome.3 To resolve these motions, the court, in its role as "gatekeeper" (see Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (hereinafter Daubert I), initiated proceedings under Federal Rule of Evidence 104. The process through which the court has endeavored to resolve the pending motions, a process the court believes to be unique in federal practice to date, is described below.

II. FACTS AND PROCEDURAL BACKGROUND

The breast implant cases at issue here were either filed initially in this court or removed from state court. The cases were then transferred to the Judicial Panel for Multidistrict Litigation, In re Silicone Gel Breast Implant Products Liability Litigation, MDL No. 926, 1994 WL 114580, where they have been managed expeditiously under the watchful eye of the transferee judge, Chief Judge Sam C. Pointer, Jr. In 1995 and 1996, Judge Pointer remanded a number of cases to Oregon for trial.

All breast implant cases remanded to Oregon federal district court have been assigned to this judge. After a series of status conferences involving all interested parties and counsel, I determined that, at least initially, similar cases should grouped for trial. I designated the following three trial groups:

                               Plaintiffs  Defendant(s)
                Group 14  Hall        Baxter
                               Pope
                               Stern
                               Preskey
                Group 25  Andrews     Bristol-Myers Squib
                               Johnston
                               Eisele
                               Bentley
                               Tytlar
                Group 36  Shervey     Bristol-Myers and
                               Zingarelli  Medical Engineering
                               Adamson     Corp
                               D. Hall
                               Young
                               Mitchel
                

After initial trial dates were set, the court instructed counsel for Groups 1 and 2 to provide a list of all lay and expert witnesses to be called at trial, together with a narrative statement of each witness' proposed testimony. The court also instructed counsel to summarize each expert witness' opinion, to identify all the materials upon which each expert would rely for his or her opinions, and to submit transcripts of any testimony given by the witness in similar cases.

Once the witness materials were duly filed, in July 1996, defendants jointly filed a series of motions in limine to exclude plaintiffs' experts' testimony concerning causation.7 To address these motions, I scheduled an integrated hearing under Rule 104(a) on the admissibility of the scientific evidence. All interested parties and counsel were invited to attend the hearing, which I set for August 1996.

In view of the complicated scientific and medical issues involved and in an effort to effectively discharge my role as "gatekeeper" under Daubert I, I invoked my inherent authority as a federal district court judge to appoint independent advisors to the court.8 See, e.g., Goetz v. Crosson, 967 F.2d 29, 37 (2d Cir.1992) (VanGraafeiland, J., concurring and dissenting) (citing Scott v. Spanjer Bros., Inc., 298 F.2d 928 (2d Cir.1962)); see also 1972 Advisory Committee Notes to FRE 702. Pursuant to that inherent authority, I began a search to find technical advisors with the necessary expertise in the fields of epidemiology, immunology/toxicology, rheumatology and chemistry to assist in evaluating the reliability and relevance of the scientific evidence.9 Dr. Richard Jones, M.D., Ph.D.,10 assisted the court by screening dozens of potential appointees and ultimately selecting four totally unbiased and uncommitted experts in the necessary fields, which the court approved and appointed. The technical advisors and their fields of expertise are: Merwyn R. Greenlick, Ph.D. (epidemiology); Robert F. Wilkens, M.D. (rheumatology); Mary Stenzel-Poore, Ph.D. (immunology/toxicology); and Ronald McClard, Ph.D. (polymer chemistry).

With the exception of Dr. McClard, whom I appointed shortly after the initial Rule 104 hearing terminated, the technical advisors reviewed the parties' voluminous materials in preparation for the hearing and observed most of the testimony in court. After his appointment, Dr. McClard reviewed all of the relevant materials and the videotaped arguments of counsel, and participated in all subsequent proceedings.

I structured the Rule 104 hearing according to subject matter, with plaintiffs presenting their experts in a particular field, followed by defendants' witnesses in the same field. All participating parties stipulated to the experts' qualifications under Rule 702. Because in proceedings pursuant to Rule 104(a) the court is not bound by rules of evidence, except those that pertain to privileges I ruled that no evidentiary objections would be permitted.11

At the hearing, which spanned four intense days (August 5-8, 1996),12 experts on both sides were questioned by counsel, the court, and the technical advisors. The parties then submitted videotaped summations, which the court and all technical advisors reviewed.13 The court also asked the parties to submit proposed questions to guide the technical advisors in evaluating the testimony and preparing their reports. After considering the parties' proposed questions, the court prepared and submitted the following questions to the advisors:

1. Is the expert's opinion supported by scientific reasoning and methodology that is generally accepted in the expert's particular scientific community or otherwise qualified as stated in Daubert II, as quoted above?14

2. Is the expert's opinion based upon scientifically reliable data?

3. If epidemiological studies have not been done or are inconclusive, what other data, such as animal studies, biophysical data, clinical experience in the field, medical records, differential diagnosis, preliminary studies, general scientific knowledge, and medical literature can justify, to a reasonable medical probability, a conclusion concerning the cause of the syndrome or disease at issue?

4. Do the methodology and data support the expert's conclusions?

5. Does the scientific data relied upon by the expert apply to the syndrome or disease in issue in these cases? For instance, are epidemiological studies directed at other typical or classical diseases relevant to an atypical disease?

The court also submitted almost all of the parties' proposed questions15 to the technical advisors for their consideration, with this instruction:

We are also enclosing suggested questions and references provided by counsel. Do not feel obligated to answer all of counsel's questions, but respond to those that you feel are relevant and that you feel will be helpful to the court in discharging our "gatekeeping" role. For instance, the defense contends that the record of the hearing does not reflect the plaintiffs' reconstruction of their witness' testimony. We leave that issue to you.16

The technical advisors submitted their reports...

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