The opinion of the court was delivered by: MCAVOY
In a bench decision rendered December 8, 1997, this Court reserved decision on defendants' summary judgment motion as to plaintiff's product liability claims based on a design defect theory. Because of a dispute as to the reliability and relevance of plaintiff's expert testimony, the Court held a hearing on January 5, 1998 to determine whether that testimony met the standard of admissibility required under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). This decision disposes of the pending motions.
TSS is a rare but potentially serious disease. The condition is believed to be caused by a toxin or toxins produced by certain strains of staphylococcus aureus (" staph aureus "). The toxin most commonly associated with menstrual TSS is known as toxic shock syndrome toxin-1 ("TSST-1") though there is literature which indicates other toxins may be involved. The basic theory of menstrual TSS is that the staph aureus bacteria, present as part of the normal vaginal flora of a certain percentage of women, produce TSST-1 which permeates the vaginal mucosa, enters the bloodstream, and produces the clinical symptoms of TSS in the few women who lack protective antibodies.
The Playtex tampons used by plaintiff's decedent at the time of her death and for several days prior were made of viscose rayon,
apparently useful because of its "super absorbency." Plaintiff has designated two experts in microbiology, Drs. Bruce A. Hanna and Philip M. Tierno, Jr., each associated with the New York University Medical Center and involved in TSS research. Each of these experts contends, on the basis of laboratory evidence as published in scientific journals, that TSST-1 production is influenced by the composition of the tampons in which the staph aureus is cultivated. They further argue that they have demonstrated experimentally and published that TSST-1 levels are highest in products containing rayon and can be significantly reduced in tampons manufactured of all cotton. This is the basis of plaintiff's products liability claim: to wit, rayon tampons are not reasonably safe because they are associated with a higher risk of TSS than cotton tampons. In fact, the two experts concluded in a 1994 study that commercially available tampons manufactured entirely out of cotton are the safest tampons for human use.
Plaintiff filed his complaint, as executor of his wife's estate, on September 22, 1995. The first and second causes of action allege that defendant was negligent in the design, manufacture, sale, marketing and promotion of the tampons in issue. The third and fourth causes of action sound in strict products liability and allege that the tampons in issue were defectively designed. The fifth and sixth causes of action set out claims for breach of implied warranties and allege defendant breached implied warranties of merchantability and fitness for a particular purpose. Plaintiff also seeks punitive damages for defendant's alleged willful, wanton and grossly negligent conduct.
Defendant moved for summary judgment dismissing all claims. In a December 8, 1997, decision from the bench, the Court granted summary judgment as to plaintiff's warranty claims and reserved as to the product liability claims, pending a hearing on the admissibility of plaintiff's expert testimony under Daubert.
The Daubert hearing was held in Albany, New York on January 5, 1998. Three witnesses testified at the hearing: for defendants, Dr. Jeffrey Parsonnet, Associate Professor of Medicine and Microbiology at Dartmouth Medical School and Staff Physician at Dartmouth Hitchcock Medical Center; for plaintiff, Drs. Hanna and Tierno.
A. Standard Under Daubert and F.R.E. 104
Under F.R.E. 104(a), "preliminary questions concerning . . . the admissibility of evidence shall be determined by the court . . .". Under Bourjaily v. United States, 483 U.S. 171, 175-176, 97 L. Ed. 2d 144, 107 S. Ct. 2775 (1987), the admissibility of evidence must be established by a preponderance of the evidence. Moreover, it is the proponent's burden under Daubert to establish admissibility, rather than the opponent's burden to establish inadmissibility. See, e.g., Lust v. Merrell Dow Pharmaceuticals, 89 F.3d 594, 598 (9th Cir. 1996); Golod v. Hoffman La Roche, 964 F. Supp. 841, 860 (S.D.N.Y. 1997).
Defendant argues that the expert testimony at issue is inadmissible under F.R.E. 702, which provides that expert opinion testimony is admissible only when "scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue . . .". The Supreme Court, in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993), made explicit the standard district courts must apply in evaluating the admissibility of scientific evidence:
Faced with a proffer of expert scientific testimony . . . 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. This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid . . .
113 S. Ct. at 2796 (footnotes omitted).
The Daubert inquiry is thus a two step process. The first part, requiring that an expert's testimony be based on "'scientific knowledge[,]' establishes a standard of evidentiary reliability." Id. at 2795. In determining whether evidence is based on scientific knowledge, courts are to consider the following factors: (1) whether the scientific theory can be and has been tested; (2) the extent to which the theory has been subject to peer review and publication; (3) the known or potential rate of error of any scientific technique at issue; and (4) whether the theory is generally accepted within the relevant scientific community. Id. at 2796-97. This list is not definitive. Daubert at 2796-97.
The second part of the inquiry -- whether the expert testimony will assist the trier of fact in understanding or determining a fact in issue -- essentially asks whether the expert's testimony "fits" the facts of the case. Daubert at 2796. This is a relevance standard. Moreover, "the 'helpfulness' standard incorporated in [F.R.E.] 702 means that the expert's opinion must relate to an issue that is actually in dispute and must provide a valid scientific connection to the pertinent inquiry." ...