Kelley v. American Heyer-Schulte Corp., Civil Action No. SA-93-CA-0145.

• Decision Date: 11 March 1997
• Docket Number: Civil Action No. SA-93-CA-0145.
• Citation: 957 F.Supp. 873
• Parties: Cathy KELLEY, Plaintiff, v. AMERICAN HEYER-SCHULTE CORPORATION f/k/a Heyer-Schulte Corporation, et al., Defendants.
• Court: U.S. District Court — Western District of Texas

Page 873

957 F.Supp. 873

Cathy KELLEY, Plaintiff, v. AMERICAN HEYER-SCHULTE CORPORATION f/k/a Heyer-Schulte Corporation, et al., Defendants.

Civil Action No. SA-93-CA-0145.

United States District Court, W.D. Texas, San Antonio Division.

March 11, 1997.

COPYRIGHT MATERIAL OMITTED

Michael T. Gallagher, Price Ainsworth, Fisher, Gallager, Perrin & Lewis, Houston, Texas, Ralph I. Knowles, Jr., and Leslie J. Bryan, Doffermyre, Shields, Canfield & Knowles, Atlanta, Georgia, for Plaintiff.

Vaughn Crawford, Snell & Wilmer, Phoenix, Arizona, D. Mitchell McFarland, Liddell, Sapp, Zivley, Hill & Laboon, L.L.P., Houston, Texas, and Daniel D. Rodarte, Rodarte & Geringer, Los Angeles, California, for Defendants.

ORDER GRANTING MOTION TO EXCLUDE AND GRANTING IN PART MOTION FOR JUDGMENT AS A MATTER OF LAW

PRADO, District Judge.

On this date, the Court considered the status of the above-styled and numbered cause. On February 10, 1997, the Court entered a preliminary order excluding the testimony of Dr. Shanna Swan and Dr. Luis Espinoza, expert witnesses for the Plaintiff. At the time of that preliminary ruling, the Court advised all parties that it would enter a more formal order on the exclusion at a later date. Pursuant to that earlier advisory, the Court now clarifies its holding and that holding's effect.

I. Background and Procedural Posture

The Plaintiff in the present case received two Heyer-Schulte implants in 1977. She claims that these implants caused her to develop Sjogren's Syndrome, an inflammatory disorder with the symptoms of dry eyes, dry mouth, and dry vagina. See Pre-Trial Order at 2. In order to establish her claim, the Plaintiff must show both general and specific causation — that is, that breast implants are capable of causing the condition she complains of, and that her breast implants were the cause-in-fact of her specific condition. See Brock v. Merrell Dow Pharmaceuticals, Inc., 874 F.2d 307, 313 (5th Cir.) (holding that inability of Plaintiff to establish that a drug could cause complained-of birth defects merited judgment as a matter of law), modified, 884 F.2d 166 (5th Cir.1989); Doddy v. Oxy, 101 F.3d 448, 463 (5th Cir. 1996) (holding that, under the Fifth Circuit's interpretation of Texas law, a Plaintiff complaining of an injury must show that the defendant was the cause-in-fact of that injury). To meet her burden, the Plaintiff offers the testimony of two scientific experts, epidemiologist Dr. Shanna Swan and rheumatologist Dr. Luis Espinoza. The Defendants have challenged the testimony of both experts under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), asserting that the experts' methods lack sufficient reliability to help the jury.

II. Standards for the admissibility of scientific expert testimony

From the time of the scientific revolution in the late seventeenth century until the present, courts have been concerned with scientific methodology — both in the presentation of evidence conforming to the rules of reason and in the methods of the proceedings themselves. See Harold J. Berman and Charles J. Reid, Jr., The Transformation of English Legal Science: From Hale to Blackstone, 45 Emory Law J. 438, 497 (1996) (relating the evolution of English legal science to the scientific revolutions of the seventeenth century). While it is the task of a jury to decide what weight to give evidence in its deliberations, it is the role of the district court under Daubert to ensure that scientific expert testimony is of sufficient validity to warrant its admission into evidence. Daubert, 509 U.S. at 597, 113 S.Ct. at 2799.

A four-part inquiry governs the admission of scientific expert testimony in the Fifth Circuit. See Christophersen v. Allied-Signal Corp., 939 F.2d 1106, 1110 (5th Cir. 1991). This inquiry focuses on the expert's qualifications under Federal Rule of Evidence 701, the expert's reasonableness in relying on his facts or data under Rule 703, the relevancy of the expert's testimony under Rules 401-403, and the sufficiency of the expert's methodology under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. at 592-95, 113 S.Ct. at 2796-97.¹

With regard to this last criterion, some explanation is necessary. In order to be admissible, a scientific expert's testimony must be supported by appropriate validation — that is, it must have a reliable basis in the knowledge and experience of the expert's discipline. Daubert, 509 U.S. at 591, 113 S.Ct. at 2795-96. The hallmark of acceptable testimony turns on whether the scientific conclusion is testable and has been tested. Lesser, but still important, considerations are whether the scientific conclusion has been published in a peer reviewed journal, the amount of error associated with the expert's technique, and whether the theory is generally accepted in the scientific community. See Daubert, 509 U.S. at 592-95, 113 S.Ct. at 2795-96.

However, the Fifth Circuit has warned courts that the focus upon methodology has some limits. An extremely probing methodological review may be appropriate only when the expert relies on particularly objectionable or unconventional scientific theories. See Carroll v. Morgan, 17 F.3d 787, 789-90 (5th Cir.1994). Moreover, Daubert is read by the Fifth Circuit to permit expert testimony on specific causation issues when the testimony is grounded in the methods and procedures of medical science. Id. In other words, a medical doctor testifying with regard to issues of causation may base his testimony upon a review of medical records (or his own exam), the doctor's experience, and a broad review of the literature. Id. See also Allen v. Pennsylvania Eng'g Corp., 102 F.3d 194, 196 (5th Cir.1996); United States v. 14.38 Acres of Land, 80 F.3d 1074 (5th Cir.1996); United States v. Posado, 57 F.3d 428, 433 (5th Cir.1995).

This Court takes very seriously the role entrusted to it by Daubert and Christophersen. See 509 U.S. at 597, 113 S.Ct. at 2798-99; See also 939 F.2d at 1110. Indeed, the Court has wide discretion in matters pertaining to the admission of scientific expert testimony — and with this discretion, the Court believes, comes a responsibility to make clear the basis of its rulings. See Christophersen, 939 F.2d at 1109 (holding that review of a district court's decisions regarding admissibility of scientific expert testimony is under a clearly erroneous standard). Accordingly, the Court will describe in some detail the process behind its decision.

III. Dr. Shanna Swan

In the main, the Plaintiff wishes to have Dr. Swan testify regarding the association described in the scientific literature between breast implants and Sjogren's Syndrome or its symptoms (sicca symptoms). Such testimony should be excluded because it is based on facts not reasonably relied upon by an expert (Rule 703), it is based upon an improper methodology (Daubert), and it fails to pass the tests of relevancy (Rules 401-403). In short, there is a panoply of reasons why this testimony must be excluded.

A. A Description of the Scientific literature

The starting place for the Court's analysis is a review of two articles in the scientific literature. In Self-Reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals: a Retrospective Cohort Study, 275 J.A.M.A. 616 (1996), Dr. Charles Hennekens and others conducted a large and very thorough epidemiology study (the Hennekens study). Through the use of questionnaires, the authors of the article interviewed 395,543 women in the health care field, 10,830 of whom had breast implants. 275 J.A.M.A. at 617. After review, the authors opted for a two-tailed statistical analysis to determine relative risk and the 95% confidence interval. Id.

The authors found that, compared with women who did not report breast implants, the relative risk of any connective tissue disease among those with breast implants was 1.24 (with a 95% confidence interval of 1.08 to 1.41, and significance to the 98.5% level). For Sjogren's Syndrome, the authors found a relative risk of 1.49, with a 95% confidence interval of .97 to 2.28, and a significance only to the 93.3% level. Because the significance level for Sjogren's Syndrome was below 95%, the authors characterized the significance as "borderline." 275 J.A.M.A. at 616. The report suggested that further research was necessary before firm conclusions could be drawn, especially because of the potential for an over-reporting bias of classic connective-tissue diseases. Id.

The second important study is Silicone Breast Prostheses and Rheumatic Symptoms: A Follow Up Study, 53 Ann.Rheum.Dis. 194 (1994), by Dr. Erik Giltay et al (the Giltay paper). This study interviewed by questionnaire 445 women, 235 with breast implants and 210 without, and found that women with breast implants reported more rheumatic complaints after implantation, calculating a relative risk for the symptom of burning eyes at 2.43, with a 95% confidence interval from 1.29 to 4.57. Id. at 194-96. The Giltay study, however, found no evidence of an increased prevalence of common rheumatic diseases among women who received implants, and it suggested that further study was necessary before any conclusion could be drawn regarding an implant-Sjogren's link. Id. Furthermore, the authors, like the authors of Hennekens study, found that bias in their sampling technique was a possible alternative cause of all their findings. Id. at 196.

These are the two most important papers to the Plaintiff's case. Indeed, Dr. Swan, the Plaintiff's own epidemiologist, found that all other studies, though perhaps relevant, were not reasonably relied upon to form opinions regarding causation. See Declaration under perjury of Dr. Shanna Swan at Paragraph 13; Transcript of Court Proceedings, February 10, 1997, 77:7-79:18 (hereinafter "Transcript"). The Court agrees with this analysis, and therefore will limit its attention to these two articles.

B. Rule...