Daubert v. Merrell Dow Pharmaceuticals, Inc.

Citation43 F.3d 1311
Decision Date04 January 1995
Docket NumberNo. 90-55397,90-55397
Parties, 25 Envtl. L. Rep. 20,856, 40 Fed. R. Evid. Serv. 1236, Prod.Liab.Rep. (CCH) P 14,094 William DAUBERT, Joyce Daubert, individually and as Guardians Ad Litem for Jason Daubert, a minor; Anita De Young, individually, and as Guardian Ad Litem for Eric Schuller, Plaintiffs-Appellants, v. MERRELL DOW PHARMACEUTICALS, INC., a Delaware corporation, Defendant-Appellee.
CourtUnited States Courts of Appeals. United States Court of Appeals (9th Circuit)

Michael H. Gottesman, Georgetown Univ. Law Center, Washington, DC, Kenneth J. Chesebro, Cambridge, MA, Mary F. Gillick, Luce, Forward, Hamilton & Scripps, San Diego, CA, and Barry J. Nace, Paulson, Nace, Norwin & Sellinger, Washington, DC, for the plaintiffs-appellants.

Charles Fried, Cambridge, MA, Hall R. Marston, George E. Berry, Dickson, Carlson & Campillo, Santa Monica, CA, and Joel I. Klein, and Richard G. Taranto, Washington, DC, for the defendant-appellee.

On Remand from the United States Supreme Court.

Before: KOZINSKI and O'SCANNLAIN, Circuit Judges, and McNAMEE, * District Judge.

KOZINSKI, Circuit Judge.

On remand from the United States Supreme Court, we undertake "the task of ensuring that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand." Daubert v. Merrell Dow Pharmaceuticals, Inc., --- U.S. ----, ----, 113 S.Ct. 2786, 2799, 125 L.Ed.2d 469 (1993).

I
A. Background

Two minors brought suit against Merrell Dow Pharmaceuticals, claiming they suffered limb reduction birth defects 1 because their mothers had taken Bendectin, a drug prescribed for morning sickness to about 17.5 million pregnant women in the United States between 1957 and 1982. See Resp't's Br. on Writ of Cert. at 2; Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349, 1350 (6th Cir.1992). This appeal deals with an evidentiary question: whether certain expert scientific testimony is admissible to prove that Bendectin caused the plaintiffs' birth defects.

For the most part, we don't know how birth defects come about. We do know they occur in 2-3% of births, whether or not the expectant mother has taken Bendectin. See Jose F. Cordero & Godfrey P. Oakley, Jr., Drug Exposure During Pregnancy: Some Epidemiologic Considerations, 26 Clinical Obstetrics & Gynecology 418, 424-25 (June 1983). Limb defects are even rarer, occurring in fewer than one birth out of every 1000. Turpin, 959 F.2d at 1353. But scientists simply do not know how teratogens (chemicals known to cause limb reduction defects) do their damage: They cannot reconstruct the biological chain of events that leads from an expectant mother's ingestion of a teratogenic substance to the stunted development of a baby's limbs. Nor do they know what it is about teratogens that causes them to have this effect. No doubt, someday we will have this knowledge, and then we will be able to tell precisely whether and how Bendectin (or any other suspected teratogen) interferes with limb development; in the current state of scientific knowledge, however, we are ignorant.

Not knowing the mechanism whereby a particular agent causes a particular effect is not always fatal to a plaintiff's claim. Causation can be proved even when we don't know precisely how the damage occurred, if there is sufficiently compelling proof that the agent must have caused the damage somehow. One method of proving causation in these circumstances is to use statistical evidence. If 50 people who eat at a restaurant one evening come down with food poisoning during the night, we can infer that the restaurant's food probably contained something unwholesome, even if none of the dishes is available for analysis. This inference is based on the fact that, in our health-conscious society, it is highly unlikely that 50 people who have nothing in common except that they ate at the same restaurant would get food poisoning from independent sources.

It is by such means that plaintiffs here seek to establish that Bendectin is responsible for their injuries. They rely on the testimony of three groups of scientific experts. One group proposes to testify that there is a statistical link between the ingestion of Bendectin during pregnancy and limb reduction defects. These experts have not themselves conducted epidemiological (human statistical) studies on the effects of Bendectin; rather, they have reanalyzed studies published by other scientists, none of whom reported a statistical association between Bendectin and birth defects. Other experts proffered by plaintiffs propose to testify that Bendectin causes limb reduction defects in humans because it causes such defects in laboratory animals. A third group of experts sees a link between Bendectin and birth defects because Bendectin has a chemical structure that is similar to other drugs suspected of causing birth defects.

The opinions proffered by plaintiffs' experts do not, to understate the point, reflect the consensus within the scientific community. The FDA--an agency not known for its promiscuity in approving drugs--continues to approve Bendectin for use by pregnant women because "available data do not demonstrate an association between birth defects and Bendectin." U.S. Department of Health and Human Services News, No. P80-45 (Oct. 7, 1980). Every published study here and abroad--and there have been many--concludes that Bendectin is not a teratogen. Turpin, 959 F.2d at 1353-56. In fact, apart from the small but determined group of scientists testifying on behalf of the Bendectin plaintiffs in this and many other cases, there doesn't appear to be a single scientist who has concluded that Bendectin causes limb reduction defects.

It is largely because the opinions proffered by plaintiffs' experts run counter to the substantial consensus in the scientific community that we affirmed the district court's grant of summary judgment the last time the case appeared before us. Daubert v. Merrell Dow Pharmaceuticals, Inc., 951 F.2d 1128, 1131 (9th Cir.1992). The standard for admissibility of expert testimony in this circuit at the time was the so-called Frye test: Scientific evidence was admissible if it was based on a scientific technique generally accepted as reliable within the scientific community. Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923). 2 We found that the district court properly applied this standard, and affirmed. The Supreme Court reversed, holding that Frye was superseded by Federal Rule of Evidence 702, --- U.S. at ----, 113 S.Ct. at 2794, and remanded for us to consider the admissibility of plaintiffs' expert testimony under this new standard.

B. Procedural Issues

First, however, we address plaintiffs' argument that we should simply remand the case so the district court can make the initial determination of admissibility under the new standard announced by the Supreme Court. There is certainly something to be said for this position, as the district court is charged with making the initial determination whether to admit evidence. In the peculiar circumstances of this case, however, we have determined that the interests of justice and judicial economy will best be served by deciding those issues that are properly before us and, in the process, offering guidance on the application of the Daubert standard in this circuit.

The district court already made a determination as to admissibility, albeit under a different standard than we apply on remand, and granted summary judgment based on its exclusion of plaintiffs' expert testimony. Daubert v. Merrell Dow Pharmaceuticals, Inc., 727 F.Supp. 570, 575-76 (S.D.Cal.1989). A grant of summary judgment may be sustained on any basis supported by the record, Leonard v. Clark, 12 F.3d 885, 889 (9th Cir.1993), so we shall consider whether the district court's grant of summary judgment can be sustained under the new standard announced by the Supreme Court. Our review here is, of course, very narrow: We will affirm the summary judgment only if, as a matter of law, the proffered evidence would have to be excluded at trial. The district court's power is far broader; were we to conclude that the expert testimony is not per se inadmissible, the district court on remand would nevertheless have discretion to reject it under Rule 403 or 702. Daubert, --- U.S. at ----, 113 S.Ct. at 2798. Such a ruling would be reviewed under the deferential abuse of discretion standard.

One other procedural matter detains us. According to plaintiffs, they weren't required to come forward with any evidence to survive summary judgment because the affidavit of Merrell's expert was itself inadmissible under Daubert; the burden thus never shifted to plaintiffs to demonstrate a genuine issue as to causation. Plaintiffs not only fail to mention the many other exhibits offered by Merrell, they also misunderstand the moving party's burden on summary judgment. Because plaintiffs bear the ultimate burden of proof on causation, Merrell had only to point to the absence of a genuine issue of material fact; it wasn't required to produce any evidence at all. See Maffei v. Northern Insulation of New York, 12 F.3d 892, 899 (9th Cir.1993). Thus, the admissibility of Merrell's expert's affidavit is beside the point; the question is whether plaintiffs adduced enough admissible evidence to create a genuine issue of material fact as to whether Bendectin caused their injuries. See Elkins v. Richardson-Merrell, Inc., 8 F.3d 1068, 1071-72 (6th Cir.1993). It is to that question we now turn.

II
A. Brave New World

Federal judges ruling on the admissibility of expert scientific testimony face a far more complex and daunting task in a post-Daubert world than before. The judge's task under Frye is relatively simple: to determine whether the method employed by the experts is generally accepted in the scientific community. Solomon, 753 F.2d at 1526. Under Daubert, we must engage in a difficult, two-part...

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