911 F.2d 941 (3rd Cir. 1990), 89-5572, DeLuca by DeLuca v. Merrell Dow Pharmaceuticals, Inc.

Docket Nº:89-5572.
Citation:911 F.2d 941
Party Name:Amy DeLUCA, an infant by her guardian ad litem, Cindy DeLUCA and Cindy DeLuca and Ronald DeLuca, Appellants, v. MERRELL DOW PHARMACEUTICALS, INC., Dr. Patrick J. Dwyer, Dr. Teresa Benecki, Dr. Pieter J. Ketelaar, Dr. Robert E. Sexton, ind. and t/a Pineland Associates.
Case Date:August 17, 1990
Court:United States Courts of Appeals, Court of Appeals for the Third Circuit

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911 F.2d 941 (3rd Cir. 1990)

Amy DeLUCA, an infant by her guardian ad litem, Cindy DeLUCA

and Cindy DeLuca and Ronald DeLuca, Appellants,



Teresa Benecki, Dr. Pieter J. Ketelaar, Dr. Robert

E. Sexton, ind. and t/a Pineland Associates.

No. 89-5572.

United States Court of Appeals, Third Circuit

August 17, 1990

Argued Nov. 30, 1989.

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John R. Connelly, Jr. (argued), Drazin and Warshaw, P.C., Red Bank, N.J., for appellants.

Susan Scott (argued), David W. Garland, Riker, Danzig, Scherer & Hyland, Morristown, N.J., for appellee Merrell Dow Pharmaceuticals.

Before BECKER, and STAPLETON, Circuit Judges and KELLY, District Judge [*].


STAPLETON, Circuit Judge:

This is an appeal in a diversity action brought under New Jersey law by the DeLuca family against Merrell Dow Pharmaceuticals Corporation, the manufacturer of

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Bendectin. 1 The DeLucas seek damages for severe birth defects suffered by Cindy DeLuca's daughter Amy. Amy was born with limb reduction defects of the lower extremities: the lower portion of her left leg is deformed with anterior bowing of the tibia, absence of the fibula and three toes, and considerable shortening; and her right foot is missing a toe. The DeLucas allege that these birth defects were caused by Cindy DeLuca's use of Bendectin during the time she was pregnant with Amy.

Merrell Dow filed a motion for summary judgment alleging that the only causation evidence produced by the DeLucas was inadmissible because all relevant epidemiological studies have determined there is no statistically significant link between the use of Bendectin during pregnancy and the type of birth defects suffered by Amy DeLuca and these studies were the only reasonable basis for expert opinions. In response, the DeLucas proffered affidavits and deposition testimony by Dr. Alan Done, an expert in pediatric pharmacology, in which Dr. Done opined that the available epidemiological data does support the conclusion that Bendectin causes limb reduction defects and that he believed, to a reasonable degree of medical certainty, Bendectin caused Amy's defects. The district court held that Dr. Done's testimony would be inadmissible at trial because it was not based on data of a type reasonably relied upon by experts in the pertinent fields in issuing opinions on these subjects, as is required by Federal Rule of Evidence 703. 131 F.R.D. 71. Since Dr. Done's testimony was the sole causation evidence the DeLucas tendered in response to Merrell Dow's motion, the district court entered summary judgment for Merrell Dow. On appeal, the DeLucas argue that the district court misapplied Federal Rule of Evidence 703 in excluding Dr. Done's testimony. We agree and we will reverse and remand for proceedings consistent with the principles articulated herein.


This is one of the last of over 1,000 suits alleging that birth defects were caused by the drug Bendectin. Bendectin, a prescription drug prescribed for morning sickness in pregnant women, was first approved for sale by the Food and Drug Administration in 1956. Public expressions of concern about Bendectin's relationship to birth defects mounted in the 1970's. In response, Bendectin's safety was examined by the FDA, and in 1980, the FDA's Advisory Committee on Fertility and Maternal Health concluded that the relevant information "did not demonstrate an increased risk of birth defects with Bendectin use" but urged that studies be continued. App. at 195. The FDA continues to approve its sale for use during pregnancy.

Despite the committee report and the fact that no published study has concluded that Bendectin increases the risk of birth defects, thousands of tort cases were filed by plaintiffs alleging that Bendectin had caused their children's birth defects. While Merrell Dow prevailed in the most prominent of the trials arising out of these numerous cases, a multi-district common issues trial involving over 800 cases, it has also had large verdicts entered against it in other suits, though most of these have been reversed on appeal or overturned on a motion for judgment n.o.v. As a result of escalating insurance and litigation costs resulting from these cases, and decreased use of Bendectin flowing from the controversy surrounding its safety, Merrell Dow has ceased production of Bendectin.

In this case, the district court faced one of the difficult questions that has pervaded Bendectin litigation to this point: whether an expert may testify, in light of existing scientific knowledge, that Bendectin is a teratogen, i.e., an agent that causes birth defects. The district court held Dr. Done's testimony to be inadmissible, citing the requirement of Federal Rule of Evidence 703, that expert opinion be based on data reasonably

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relied upon by experts in the relevant field. The district court reached this conclusion despite the fact that most of the data relied upon by Dr. Done was data from peer reviewed articles in medical journals that was relied upon by the authors of these articles, as well as by Merrell Dow's own expert.

In the record that served as the basis for the district court's decision, Merrell Dow did not identify particular data sets it believed Dr. Done could not reasonably rely upon. Nor did it address the specific methodology and reasoning underlying Dr. Done's conclusion that Bendectin is a teratogen. 2 Instead, Merrell Dow relied upon the great weight of scientific opinion in its favor and upon prior cases in which testimony that Bendectin is a teratogen was held to be inadmissible or insufficient to support a verdict. 3 This was consistent with its apparent litigation strategy which was to emphasize that "[i]n all material respects, the instant case is identical to the cases where summary judgment has been granted in Merrell Dow's favor." App. at 38.

Following Merrell Dow's lead, the district court did not point to specific deficiencies in the data utilized by Dr. Done and while it cited Rule 703, it made no record-supported, factual finding that Dr. Done had relied upon data experts in the field would have considered unreliable. Instead, the district court devoted most of its opinion to surveying the case law cited by Merrell Dow. In only two brief sentences of its opinion did the district court address Dr. Done's statistical analysis of the available epidemiological evidence. The first sentence states that the authors of the studies used by Dr. Done concluded that a "statistically significant" link between Bendectin and birth defects existed only for defects other than limb reduction defects or concluded that Bendectin does not cause birth defects. App. at 29. Dr. Done, as we shall see, readily admits that his interpretation of the data collected for these studies differs from the authors'. The second sentence appears to discard Dr. Done's analysis because he is not an epidemiologist, id., despite Merrell Dow's express agreement to assume, for purposes of its motion for summary judgment, that Dr. Done was qualified to read and interpret epidemiological studies. On this basis, the district court held that the DeLucas had "not approached a showing that Dr. Done's opinion has a foundation as required by Federal Rule of Evidence 703." Id.

  1. Standard of Review

    Our review of a district court's decision to exclude the testimony of an expert is ordinarily limited to ensuring there has been no abuse of discretion, but to the extent the district court's ruling turns on an interpretation of a Federal Rule of Evidence our review is plenary. In re Japanese Electronic Products Litigation, 723 F.2d 238, 276 (3d Cir.1983), rev'd on other grounds sub. nom., Matsushita Electric Industrial Co. Ltd. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); United States v. Furst, 886 F.2d 558, 571 (3d Cir.1989). The standard of review of a district court's entry of summary

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    judgment is plenary, and we apply the same standard as the district court. Erie Telecommunications, Inc. v. City of Erie, 853 F.2d 1084, 1093 (3d Cir.1988). Summary judgment is appropriate when, after considering the record evidence in the light most favorable to the nonmoving party, no genuine issue of material fact exists and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c).

  2. The Relevant Scientific Principles and Tendered Evidence

    To competently analyze the legal issues presented by this appeal, an understanding of the relevant scientific principles, albeit necessarily a rudimentary one drawn primarily from the relevant sources cited to by the parties, is essential. Problematic issues of causation arise in Bendectin cases because the etiology of most birth defects is unknown. There is no apparent way to determine from clinical examinations of Amy DeLuca whether her limb defects were the result of her mother's exposure to Bendectin, as opposed to another possible teratogen, or whether her birth defects are simply an inexplicable natural occurrence not induced by her mother's exposure to an outside agent. Rather, the only particularistic evidence the DeLucas can show to strengthen the inference that Amy DeLuca's birth defects were caused by Bendectin is to rule in Bendectin as a possible cause by showing that Amy was exposed to it during the time her limbs were developing, i.e., during organogenesis, and to rule out other possible causes by showing that Amy was not exposed to them during the critical period of organogenesis. Merrell Dow did not contend before the district court that the DeLucas failed to present sufficient evidence in this regard. 4

    Thus, the DeLucas must rely primarily on inferences drawn from epidemiological...

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