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[J-190-99] IN THE SUPREME COURT OF PENNSYLVANIA EASTERN DISTRICT

JEFFREY BLUM, a minor, by his parents and natural guardians, JOAN and FRED BLUM, and JOAN and FRED BLUM, in their own right, Appellants v. MERRELL DOW PHARMACEUTICALS, INC., Appellee

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No. 1 E.D. Appeal Docket 1999

Appeal from the order of the Superior Court dated December 29, 1997 at No. 3711 Philadelphia 1995, reversing the order of the Court of Common Pleas of Philadelphia County, dated September 15, 1995 at No. 1027, September Term, 1982

ARGUED: October 18, 1999

OPINION OF THE COURT

MR. CHIEF JUSTICE FLAHERTY

DECIDED: December 22, 2000

In this prescription drug product liability case, we granted allocatur to consider whether the Frye1 rule still governs the admissibility of expert scientific testimony in Pennsylvania or whether the Daubert2 rule has superseded it. The Frye rule bars novel scientific evidence until it has achieved "general acceptance" in the relevant scientific community. The Daubert approach relaxes this requirement to a degree and may permit

1. Frye v. United States, 293 F. 1013 (D.C.Cir. 1923). 2. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

evidence based on scientific theory not yet generally accepted so long as a variety of specified factors can be deemed to establish a high level of reliability. The trial court permitted plaintiffs' expert scientists to present testimony arguably admissible under Daubert, and the jury entered a verdict for plaintiffs. Superior Court reversed, holding that the Frye rule was the proper standard; that under Frye, the experts should not have been permitted to testify; that the verdict should be vacated and the case remanded for entry of judgment in favor of appellee Merrell Dow.

The case involves the drug Bendectin, alleged to be an agent which causes the production of physical defects in developing embryos. The Blums alleged that their son Jeffrey Blum was born with a crippling clubbed feet injury due to the ingestion of Bendectin by his mother, Joan Blum, during his fetal gestation.

At trial, Blums presented expert scientific causation testimony, some of which was corroborated by defense experts, to establish that Bendectin, manufactured by Merrell Dow Pharmaceuticals, Inc., caused Jeffrey Blum's clubbed feet. The scientific testimony was based on data from epidemiological studies, chemical structure analysis, in vitro (test tube) and in vivo (animal) teratology studies, as well as unpublished "recalculations" performed on the findings of previously published studies. The trial court apparently admitted the testimony under the evidentiary rule embodied in Daubert, and the jury returned a verdict for the Blums and against Merrell Dow in the amount of $19.2 million, including $15 million in punitive damages. Merrell Dow moved unsuccessfully for judgment notwithstanding the verdict. On appeal, Superior Court held that it was error for the trial court to apply Daubert,

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a standard somewhat less exacting than that of Frye, after this court specifically deferred a decision on that question. Superior Court therefore vacated the judgment and remanded the case for entry of j.n.o.v. in favor of Merrell Dow.

This court adopted the Frye test in Commonwealth v. Topa, 471 Pa. 223, 369 A.2d 1277 (1977). It has been applied on numerous occasions since 1977.3 When Crews, supra, discussed and applied the test, it also discussed the Daubert test, but declined to apply it, stating that the question of "whether or not the rationale of Daubert will supersede or modify the Frye test in Pennsylvania is left to another day." Crews, 536 Pa. at 519 n.2, 640 A.2d 400 n.2.

As we recognized in Crews, Daubert relaxes, to some extent, the impediments to admission of novel scientific evidence. Under Daubert, expert scientific testimony is admissible if it fulfills two criteria. First, it must relate to "scientific knowledge," thereby establishing "a standard of evidentiary reliability," which "will be based upon scientific validity." To constitute scientific knowledge, the evidence must be grounded in the methods and procedures of science, based on more than subjective belief or unsupported speculation, and supported by appropriate scientific validation. The second criterion is that the evidence must be relevant; it must assist the trier of fact to understand the evidence or to determine a fact in issue. Under Daubert, in federal trials, "general acceptance" no longer constitutes a threshold necessity in determining admissibility. Other factors are

3. See cases cited in Commonwealth v. Crews, 536 Pa. 508, 518, 640 A.2d 395, 399400 (1994).

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whether the technique or methodology can be or has been tested, i.e., its "falsifiability, or refutability, or testability." Another consideration is whether the theory or technique has been subjected to peer review and publication. Other factors bearing on scientific

validation are the known or potential rate of error, and the existence and maintenance of standards controlling the technique's operation. Crews, supra, 536 Pa. at 518 n.2, 640 A.2d at 400 n.2.

The essential difference between Frye and Daubert, is that Frye requires the scientific community to reach some consensus as to reliability then relies on such consensus to determine the admissibility of the challenged scientific evidence. Daubert, on the other hand, examining the same factors which lead to general acceptance in the scientific community, abandons the standard of "general acceptance" and substitutes a judicial evaluation and determination of scientific reliability.

In considering whether this court should follow the lead of the federal courts in moving from the Frye to the Daubert standard, we note that the parties were content to frame their arguments within the traditional framework established under Frye.4 Moreover, 4. Only the amicus brief for the Pennsylvania Defense Institute squarely states a position on whether the court should continue to adhere to Frye, arguing in the affirmative. Its arguments are, in summary: trial courts should not become the testing grounds for untried and untested scientific theories; Frye is more likely than Daubert to yield consistent results when applied by different jurists; there is an undeniable simplicity to Frye; by requiring evidence to be measured by an objective standard, i.e., what others in the area deem reliable, Frye prevents experts from providing self-serving support for their own opinions; and the Frye standard has been the law in the Commonwealth for more than twenty years.

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the primary evidence at trial supporting the conclusion that Bendictin caused appellant's birth defect, the testimony of Dr. Alan K. Done, was so flawed5 as to render his conclusions

5. Over thirty published epidemiological studies have found no statisticallysignificant association between Bendectin and limb defects; the FDA, after complete review in the 1980s, found that available evidence showed no basis for a conclusion that Bendectin causes or increases the risk of birth defects in humans. Nevertheless, Dr. Done, who is not an epidemiologist, discounted such conclusions on the basis of a selective review of the data from several of these studies, in which he detached the underlying data from the controls set up by the studies, and recalculated using simple math (as opposed to epidemiological principles). In effect, Dr. Done worked backwards through the science, from the statistical results back to the original mere associations that led to the studies in the first place. This procedure cannot be fairly described as generally accepted methodology for purposes of the Frye standard. See generally Blum v. Merrell Dow Pharmaceuticals, Inc., 705 A.2d 1314, 1322-25 (Pa.Super. 1997). With respect to application of the Daubert formulation, numerous federal courts have determined that Dr. Done's testimony is not admissible. See Lust v. Merrell Dow Pharmaceuticals, Inc., 89 F.3d 594, 596 (9th Cir. 1996) (quoting the trial court as follows: "Dr. Done has seen fit to `pick and choose' from the scientific landscape and present the Court with what he believes the final picture to look like. This is hardly scientific. Through Dr. Done's manipulation of the studies of others, he could suggest almost any result to the Court. The scientific world, however, does not operate with such a disjointed approach." The court added that "Done . . . was [in 1984] already a professional plaintiff's witness. It is not unreasonable to presume that Done's opinion on Clomid was influenced by a litigation-driven financial incentive." Id. at 597 (emphasis added). Referring to Done's testimony, the court continued: "When a scientist claims to rely on a method practiced by most scientists, yet presents conclusions that are shared by no other scientist, the [trial] court should be wary that the method has not been faithfully applied." Id. at 598.); Richardson by Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 829 (D.C. Cir. 1988) (holding that Dr. Done's conclusion was not capable of proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence), cert. denied, 493 U.S. 882, 110 S.Ct. 218 (1989); Lynch v. Merrell-National Laboratories,Inc., 830 F.2d 1190, 1196 (1st Cir. 1987)(holding that Dr. Done's reanalysis was not an adequate epidemiological basis for his opinion); DeLuca v. Merrell Dow, 791 F.Supp. 1042, 1054 (D.N.J. 1992)(excluding Dr. Done's testimony in part because he had concluded that there was no other more likely cause of the birth defect, but provided no evidence ruling out any other possible causes, such as a previous abortion), aff'd, 6 F.3d 778 (3d Cir. 1993), cert. denied, 510 U.S. 1044, 114 S.Ct. 691 (1994). Dr. Done's expert testimony was also rejected in Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159 (D.C.Cir. 1990); Lee v. Richardson-Merrell, Inc., 772 F.Supp. 1027, 1032
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unreliable and therefore inadmissible under either Frye or Daubert, so a choice between the two standards is unnecessary to the resolution of this appeal. It would appear to be jurisprudentially unsound, therefore, to utilize this case as a vehicle to evaluate the wisdom of such a change.

The record contains sufficient evidence for us to agree with Superior Court's conclusion that both Frye and Daubert would bar the challenged scientific testimony. Superior Court was therefore correct in holding that the trial court erred in denying Merrell Dow's motion for j.n.o.v. Accordingly, we will affirm the judgment of Superior Court.

Affirmed.

Messrs. Justice Cappy and Castille file dissenting opinions.

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(W.D.Tenn. 1991), aff'd 961 F.2d 1577 (6th Cir. 1992); Richardson by Richardson v. Richardson-Merrell, 649 F.Supp. 799 (D.D.C. 1986), aff'd 857 F.2d 823 (D.C.Cir. 1988); Wade-Greaux v. Whitehall Laboratories, Inc., 874 F.Supp. 1441 (D.V.I.), aff'd 46 F.3d 1120 (3d Cir. 1994).

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