18. Dr. Swan, plaintiffs' epidemiologist and statistician, could not verify the accuracy of Dr. Done's calculations. In addition, she testified that she was frequently unable to determine the precise methodology used by Dr. Done in selecting data to calculate relative risks and confidence intervals, and in actually calculating those intervals. See Findings of Fact supra at PP35, 36, 38, 42, 45, 48 & 54.
19. Similarly, defense experts, Drs. Monson, Wright and Lamm, all qualified epidemiologists, in many cases could not replicate Dr. Done's calculations. Monson Direct at 27-28; Wright Direct at 33; Lamm Direct at 15-18.
20. Although Dr. Done's qualifications or lack thereof may not alone constitute a sufficient basis upon which to exclude his testimony, his lack of formal training in epidemiology weighs against admissibility.
iv. The Non-Judicial Uses to Which the Scientific Technique Are Put
21. Dr. Done has presented no evidence that his methodology has been put to any non-judicial use. Although "the Federal Rules of Evidence contain no requirement that an expert's testimony be based upon reasoning subjected to peer-review and published in the professional literature," DeLuca, 911 F.2d at 954, the fact that Dr. Done's methodology has not been used non-judicially weighs against its admissibility. Downing, 753 F.2d at 1239; see also Perry v. United States, 755 F.2d 888, 892 (11th Cir. 1985) ("the examination of a scientific study by a cadre of lawyers is not the same as its examination by others trained in the field of science or medicine").
v. The Frequency with Which a Technique Leads to Erroneous Results
22. The "ultimate touchstone" of the soundness and reliability of a particular methodology or technique "is helpfulness to the trier of fact." DeLuca, 911 F.2d at 956. Helpfulness "turns on whether the expert's 'technique or principle [is] sufficiently reliable so that it will aid the jury in reaching accurate results.'" Id. at 956 (quoting 3 J. Weinstein & M. Berger, Weinstein's Evidence P702, at 702-35 (1988)). In this regard, "Downing teaches that the frequency with which a scientific technique leads to erroneous results bears heavily on its reliability for evidential purposes." DeLuca, 911 F.2d at 956 n.19 (citing Downing, 753 F.2d at 1239).
23. Dr. Swan, plaintiffs' other expert, did not independently verify the data included on Dr. Done's chart, did not check his calculations and did not check to see if Dr. Done correctly extracted the data from the articles as to which he made no calculations. Swan Test., Tr. 7/12/91, at 7-14.
Dr. Swan merely commented on Dr. Done's methodology as he described it and "took as a given that he did what he said he did." Swan Test., Tr. 7/12/91, at 9-21.
24. To the extent that Dr. Done used ADR or DER data as a basis for his conclusion that Bendectin is a teratogen, the methodology produces inaccurate and unreliable results because such data are unreliable for determining causation. See Findings of Fact supra at PP69-75.
25. The testimony on remand established that Dr. Done's epidemiologic methodology yielded erroneous results so frequently that it is not helpful to the trier of fact. See Findings of Fact supra at PP34-54. This factor most certainly weighs against admissibility.
26. Plaintiffs must "make more than a prima facie showing (e.g., the testimony of a single qualified expert) that a technique is reliable." Downing, 753 F.2d at 1240 n.21. Plaintiffs have failed to make even a prima facie showing that Dr. Done's methodology is reliable.
27. The above Downing factors used in evaluating the reliability and soundness of Dr. Done's methodology weigh against the admissibility of his testimony.
B. The Possibility That Admitting the Evidence Would Overwhelm, Confuse, or Mislead the Jury
28. Testimony also should be excluded if it would overwhelm, confuse or mislead the jury. Thus, even if this Court did not conclude that Dr. Done's methodology is unreliable, the possibility that his testimony would overwhelm, confuse or mislead the jury warrants its exclusion. DeLuca, 911 F.2d at 957; Downing, 753 F.2d at 1237. In making that determination, the Court must keep in mind "the extent to which probative scientific evidence is capable of being properly utilized by the jury." DeLuca, 911 F.2d at 957. Specifically, will the jury be able to give Dr. Done's testimony appropriate weight, or will the evidence because of its scientific origins take on an importance beyond its probative value? Id.
29. Although Dr. Done's inclusion and exclusion of certain data may be nothing more than a matter for the experts to battle, when viewed in light of the numerous errors in calculation of that data and selectivity biases, this Court concludes that Dr. Done's testimony would serve to confuse and mislead a jury.
30. There is a danger that scientific evidence will mislead a jury "where the jury is not presented with the data on which the expert relies, but must instead accept the expert's assertions as to the accuracy of his conclusions." Downing, 753 F.2d at 1239. Here, Dr. Done has presented on his charts the post-selection and post-calculation numbers, without explaining the precise derivation of the numbers. Moreover, Dr. Done has not specifically ruled out Mrs. DeLuca's cigarette smoking or her prior abortion as possible causes of Amy's birth defects. The potential for confusion is evident.
31. Because I conclude that Dr. Done's methodology is novel and unreliable, and because his testimony has the potential of confusing and misleading a jury, Federal Rule of Evidence 702 requires its exclusion.
IV. Federal Rule of Evidence 703
32. Federal Rule of Evidence 703 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.
Fed. R. Evid. 703.
33. Rule 703 and Rule 104(a) require a district court to "'make a factual inquiry. . . as to what data experts in the field find reliable.'" DeLuca, 911 F.2d at 952 (quoting In re Japanese Elec. Prods. Antitrust Litig., 723 F.2d 238, 276 (3d Cir. 1983), rev'd on other grounds sub nom. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986)). Generally, if an expert avers that his testimony is based on data experts in the field find reliable, then Rule 703's requirements are usually satisfied. DeLuca, 911 F.2d at 952.
34. "Rule 703 is satisfied once there is a showing that an expert's testimony is based on the type of data a reasonable expert in the field would use in rendering an opinion on the subject at issue; it does not address the reliability or general acceptance of an expert's methodology" as does Rule 702. Id. at 953.
35. Even if expert testimony is admissible under Rule 703, it may be excluded as unreliable under Rule 702.
In re Paoli, 916 F.2d at 854 n.29.
36. Dr. Done purports to have taken the numbers he entered in the boxes on his chart from either the underlying studies themselves, or, in the articles were no calculations were made, from his own calculations. In many cases, as previously noted, this is simply not true. Dr. Done frequently used numbers of his own, even where calculations were available. Often, his "re-calculations" were wrong and could not be replicated by plaintiff's other expert, Dr. Swan, or the defense experts. See Findings of Fact supra at P36. The hearing conducted by this Court has revealed that the data used by Dr. Done is not, as was represented to the Court of Appeals, DeLuca, 911 F.2d at 953, the data used by Merrell Dow's own expert, Dr. Brenholz, in formulating her opinion. Rather, Dr. Done has re-calculated the data provided in the underlying studies and has used that "new data" in formulating his opinion that Bendectin is a teratogen. This "new data" has not and cannot in many instances be replicated by other experts in the field or even be explained.
37. In addition, Dr. Done specifically relied upon several types of data experts in the field would not use in forming their opinions: (i) his own analysis of the ADRs or DERs for Bendectin; (ii) the preliminary Jick drafts, as well as other drafts, see Findings of Fact supra at P61; and (iii) Dr. Swan's reanalysis of the Cordero data.
Faich Direct at 6 & 10. In fact, Dr. Done admitted the unreliability of the Jick draft during cross-examination. Done Test., Tr. 7/10/91, at 130.
38. Dr. Done thus has used data upon which no epidemiologist would rely. This is where Rules 702 and 703 intersect. As the Court of Appeals stated: "If a study's method of data collection is faulty, it may be that no expert would rely upon the data generated as a basis for drawing any inference about the studied subject." DeLuca, 911 F.2d at 955 n.14.
39. Because I conclude that Dr. Done has used data experts in the field would not use in rendering their opinions on the subject, Federal Rule of Evidence 703 requires its exclusion.
40. Summary judgment is proper where a party fails to establish the existence of an element essential to his case and where he bears the burden of proof. Celotex Corp. v. Catrett, 477 U.S. 317, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). Because this Court has concluded that Dr. Done's testimony is inadmissible under Federal Rules of Evidence 702 and 703, I must conclude that plaintiffs have not met their burden under Celotex to produce evidence sufficient to raise a genuine issue of material fact as to whether Amy DeLuca's birth defects were caused by maternal ingestion of Bendectin during pregnancy. Id. ; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986); Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986). Accordingly, summary judgment will be entered in favor of Merrell Dow.
VI. Sufficiency of the Evidence
41. Because I have concluded that Dr. Done's testimony is inadmissible under Federal Rules of Evidence 702 and 703, I do not reach the issue whether his testimony, if admitted, would meet the applicable burden of proof standard under New Jersey law.
For the foregoing reasons,
It is on this 29th day of April, 1992,
ORDERED that defendant Merrell Dow's motion for summary judgment be and is hereby GRANTED.
GARRETT E. BROWN, JR., U.S.D.J.