Daubert v. Merrell Dow Pharmaceuticals, 113 S. Ct.2786 (1993)
Daubert v. Merrell Dow Pharmaceuticals, 113 S. Ct.2786 (1993)
Daubert v. Merrell Dow Pharmaceuticals, 113 S. Ct.2786 (1993)
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.
No. 90-55397.
Before: KOZINSKI and O'SCANNLAIN, Circuit Judges, and McNAMEE, *District Judge.
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, 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., 509 U.S. 579, ----, 113 S.Ct.
2786, 2799, 125 L.Ed.2d 469 (1993).
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, 509 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.
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
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 analysis. First, we must determine
nothing less than whether the experts' testimony reflects “scientific knowledge,” whether
their findings are “derived by the scientific method,” and whether their work product
amounts to “good science.” 509 U.S. at ----, ----, 113 S.Ct. at 2795, 2797. Second, we
must ensure that the proposed expert testimony is “relevant to the task at hand,” id. at
----, 113 S.Ct. at 2797, i.e., that it logically advances a material aspect of the proposing
party's case. The Supreme Court referred to this second prong of the analysis as the
“fit” requirement. Id. at ----, 113 S.Ct. at 2796.
The first prong of Daubert puts federal judges in an uncomfortable position. The
question of admissibility only arises if it is first established that the individuals whose
testimony is being proffered are experts in a particular scientific field; here, for example,
the Supreme Court waxed eloquent on the impressive qualifications of plaintiffs' experts.
Id. at ---- n. 2, 113 S.Ct. at 2791 n. 2. Yet something doesn't become “scientific
knowledge” just because it's uttered by a scientist; nor can an expert's self-serving
assertion that his conclusions were “derived by the scientific method” be deemed
conclusive, else the Supreme Court's opinion could have ended with footnote two. As
we read the Supreme Court's teaching in Daubert, therefore, though we are largely
untrained in science and certainly no match for any of the witnesses whose testimony we
are reviewing, it is our responsibility to determine whether those experts' proposed
testimony amounts to “scientific knowledge,” constitutes “good science,” and was
“derived by the scientific method.”
The task before us is more daunting still when the dispute concerns matters at the very
cutting edge of scientific research, where fact meets theory and certainty dissolves into
probability. As the record in this case illustrates, scientists often have vigorous and
sincere disagreements as to what research methodology is proper, what should be
accepted as sufficient proof for the existence of a “fact,” and whether information derived
by a particular method can tell us anything useful about the subject under study.
Our responsibility, then, unless we badly misread the Supreme Court's opinion, is to
resolve disputes among respected, well-credentialed scientists about matters squarely
within their expertise, in areas where there is no scientific consensus as to what is and
what is not “good science,” and occasionally to reject such expert testimony because it
was not “derived by the scientific method.” Mindful of our position in the hierarchy of
the federal judiciary, we take a deep breath and proceed with this heady task.
B. Deus ex Machina
The Supreme Court's opinion in Daubert focuses closely on the language of Fed.R.Evid.
702, which permits opinion testimony by experts as to matters amounting to “scientific ․
knowledge.” The Court recognized, however, that knowledge in this context does not
mean absolute certainty. 509 U.S. at ----, 113 S.Ct. at 2795. Rather, the Court said,
“in order to qualify as ‘scientific knowledge,’ an inference or assertion must be derived by
the scientific method.” Id. Elsewhere in its opinion, the Court noted that Rule 702 is
satisfied where the proffered testimony is “based on scientifically valid principles.” Id.
at ----, 113 S.Ct. at 2799. Our task, then, is to analyze not what the experts say, but
what basis they have for saying it.
Which raises the question: How do we figure out whether scientists have derived their
findings through the scientific method or whether their testimony is based on scientifically
valid principles? Each expert proffered by the plaintiffs assures us that he has “utiliz[ed]
the type of data that is generally and reasonably relied upon by scientists” in the relevant
field, see, e.g., Newman Aff. at 5, and that he has “utilized the methods and methodology
that would generally and reasonably be accepted” by people who deal in these matters,
see, e.g., Gross Aff. at 5. The Court held, however, that federal judges perform a
“gatekeeping role,” Daubert, 509 U.S. at ----, 113 S.Ct. at 2798; to do so they must
satisfy themselves that scientific evidence meets a certain standard of reliability before it
is admitted. This means that the expert's bald assurance of validity is not enough.
Rather, the party presenting the expert must show that the expert's findings are based
on sound science, and this will require some objective, independent validation of the
expert's methodology.
While declining to set forth a “definitive checklist or test,” id. at ----, 113 S.Ct. at 2796,
the Court did list several factors federal judges can consider in determining whether to
admit expert scientific testimony under Fed.R.Evid. 702: whether the theory or technique
employed by the expert is generally accepted in the scientific community; whether it's
been subjected to peer review and publication; whether it can be and has been tested;
and whether the known or potential rate of error is acceptable. Id. at ----, 113 S.Ct. at
2796-97.3 We read these factors as illustrative rather than exhaustive; similarly, we do
not deem each of them to be equally applicable (or applicable at all) in every
case.4 Rather, we read the Supreme Court as instructing us to determine whether the
analysis undergirding the experts' testimony falls within the range of accepted standards
governing how scientists conduct their research and reach their conclusions.
One very significant fact to be considered is whether the experts are proposing to testify
about matters growing naturally and directly out of research they have conducted
independent of the litigation, or whether they have developed their opinions expressly
for purposes of testifying. That an expert testifies for money does not necessarily cast
doubt on the reliability of his testimony, as few experts appear in court merely as an
eleemosynary gesture. But in determining whether proposed expert testimony amounts
to good science, we may not ignore the fact that a scientist's normal workplace is the lab
or the field, not the courtroom or the lawyer's office. 5
We have examined carefully the affidavits proffered by plaintiffs' experts, as well as the
testimony from prior trials that plaintiffs have introduced in support of that testimony,
and find that none of the experts based his testimony on preexisting or independent
research. While plaintiffs' scientists are all experts in their respective fields, none claims
to have studied the effect of Bendectin on limb reduction defects before being hired to
testify in this or related cases.
If the proffered expert testimony is not based on independent research, the party
proffering it must come forward with other objective, verifiable evidence that the
testimony is based on “scientifically valid principles.” One means of showing this is by
proof that the research and analysis supporting the proffered conclusions have been
subjected to normal scientific scrutiny through peer review and publication. 6 Huber,
Galileo's Revenge at 209 (suggesting that “[t]he ultimate test of [a scientific expert's]
integrity is her readiness to publish and be damned”).
Peer review and publication do not, of course, guarantee that the conclusions reached
are correct; much published scientific research is greeted with intense skepticism and is
not borne out by further research. But the test under Daubert is not the correctness of
the expert's conclusions but the soundness of his methodology. See n. 11 infra. That
the research is accepted for publication in a reputable scientific journal after being
subjected to the usual rigors of peer review is a significant indication that it is taken
seriously by other scientists, i.e., that it meets at least the minimal criteria of good
science. Daubert, 509 U.S. at ----, 113 S.Ct. at 2797 (“[S]crutiny of the scientific
community is a component of ‘good science.’ ”). If nothing else, peer review and
publication “increase the likelihood that substantive flaws in methodology will be
detected.” Daubert, 509 U.S. at ----, 113 S.Ct. at 2797.7
Bendectin litigation has been pending in the courts for over a decade, yet the only
review the plaintiffs' experts' work has received has been by judges and juries, and the
only place their theories and studies have been published is in the pages of federal and
state reporters.8 None of the plaintiffs' experts has published his work on Bendectin in
a scientific journal or solicited formal review by his colleagues. Despite the many years
the controversy has been brewing, no one in the scientific community-except defendant's
experts-has deemed these studies worthy of verification, refutation or even comment.
It's as if there were a tacit understanding within the scientific community that what's
going on here is not science at all, but litigation. 9
Plaintiffs have made no such showing. As noted above, plaintiffs rely entirely on the
experts' unadorned assertions that the methodology they employed comports with
standard scientific procedures. In support of these assertions, plaintiffs offer only the
trial and deposition testimony of these experts in other cases. While these materials
indicate that plaintiffs' experts have relied on animal studies, chemical structure analyses
and epidemiological data, they neither explain the methodology the experts followed to
reach their conclusions nor point to any external source to validate that methodology.
We've been presented with only the experts' qualifications, their conclusions and their
assurances of reliability. Under Daubert, that's not enough.
This is especially true of Dr. Palmer-the only expert willing to testify “that Bendectin did
cause the limb defects in each of the children.” Palmer Aff. at 8. In support of this
conclusion, Dr. Palmer asserts only that Bendectin is a teratogen and that he has
examined the plaintiffs' medical records, which apparently reveal the timing of their
mothers' ingestion of the drug. Dr. Palmer offers no tested or testable theory to explain
how, from this limited information, he was able to eliminate all other potential causes of
birth defects, nor does he explain how he alone can state as a fact that Bendectin caused
plaintiffs' injuries. We therefore agree with the Sixth Circuit's observation that “Dr.
Palmer does not testify on the basis of the collective view of his scientific discipline, nor
does he take issue with his peers and explain the grounds for his differences. Indeed,
no understandable scientific basis is stated. Personal opinion, not science, is testifying
here.” Turpin, 959 F.2d at 1360. For this reason, Dr. Palmer's testimony is inadmissible
as a matter of law under Rule 702.
The failure to make any objective showing as to admissibility under the first prong of Rule
702 would also fatally undermine the testimony of plaintiffs' other experts, but for the
peculiar posture of this case. Plaintiffs submitted their experts' affidavits while Frye was
the law of the circuit and, although they've not requested an opportunity to augment
their experts' affidavits in light of Daubert, the interests of justice would be disserved by
precluding plaintiffs from doing so. Given the opportunity to augment their original
showing of admissibility, plaintiffs might be able to show that the methodology adopted
by some of their experts is based on sound scientific principles. For instance, plaintiffs'
epidemiologists might validate their reanalyses by explaining why they chose only certain
of the data that was available, or the experts relying on animal studies might point to
some authority for extrapolating human causation from teratogenicity in animals. 12
Were this the only question before us, we would be inclined to remand to give plaintiffs
an opportunity to submit additional proof that the scientific testimony they proffer was
“derived by the scientific method.” Daubert, however, establishes two prongs to the
Rule 702 admissibility inquiry. See pp. 1315-16 supra. We therefore consider whether
the testimony satisfies the second prong of Rule 702: Would plaintiffs' proffered scientific
evidence “assist the trier of fact to ․ determine a fact in issue”? Fed.R.Evid. 702.
In elucidating the second requirement of Rule 702, Daubert stressed the importance of
the “fit” between the testimony and an issue in the case: “Rule 702's ‘helpfulness'
standard requires a valid scientific connection to the pertinent inquiry as a precondition
to admissibility.” 509 U.S. at ----, 113 S.Ct. at 2796. Here, the pertinent inquiry is
causation. In assessing whether the proffered expert testimony “will assist the trier of
fact” in resolving this issue, we must look to the governing substantive standard, which
in this case is supplied by California tort law.
Plaintiffs do not attempt to show causation directly; instead, they rely on experts who
present circumstantial proof of causation. Plaintiffs' experts testify that Bendectin is a
teratogen because it causes birth defects when it is tested on animals, because it is similar
in chemical structure to other suspected teratogens, and because statistical studies show
that Bendectin use increases the risk of birth defects. Modern tort law permits such
proof, but plaintiffs must nevertheless carry their traditional burden; they must prove
that their injuries were the result of the accused cause and not some independent factor.
In the case of birth defects, carrying this burden is made more difficult because we know
that some defects-including limb reduction defects-occur even when expectant mothers
do not take Bendectin, and that most birth defects occur for no known reason.
California tort law requires plaintiffs to show not merely that Bendectin increased the
likelihood of injury, but that it more likely than not caused their injuries. See Jones v.
Ortho Pharmaceutical Corp., 163 Cal.App.3d 396, 403, 209 Cal.Rptr. 456 (1985). In
terms of statistical proof, this means that plaintiffs must establish not just that their
mothers' ingestion of Bendectin increased somewhat the likelihood of birth defects, but
that it more than doubled it-only then can it be said that Bendectin is more likely than
not the source of their injury. Because the background rate of limb reduction defects is
one per thousand births, plaintiffs must show that among children of mothers who took
Bendectin the incidence of such defects was more than two per thousand. 13
With the exception of Dr. Palmer, whose testimony is inadmissible under the first prong
of the Rule 702 analysis, see p. 1319 supra,18 the remaining experts proffered by plaintiffs
were equally unprepared to testify that Bendectin caused plaintiffs' injuries; they were
willing to testify only that Bendectin is “capable of causing” birth defects. Crescitelli Aff.
at 3, 8; Glasser Aff. at 6, 8; Gross Aff. at 9; Newman Aff. at 5, 9; Swan Aff. at 7.
Plaintiffs argue “these scientists use the words ‘capable of causing’ meaning that it does
cause. This is an ambiguity of language․ If something is capable of causing damage
in humans, it does.” Tape of Oral Arg. Mar. 22, 1994. But what plaintiffs must prove
is not that Bendectin causes some birth defects, but that it caused their birth defects.
To show this, plaintiffs' experts would have had to testify either that Bendectin actually
caused plaintiffs' injuries (which they could not say) or that Bendectin more than doubled
the likelihood of limb reduction birth defects (which they did not say).
As the district court properly found below, “the strongest inference to be drawn for
plaintiffs based on the epidemiological evidence is that Bendectin could possibly have
caused plaintiffs' injuries.” 727 F.Supp. at 576. The same is true of the other testimony
derived from animal studies and chemical structure analyses-these experts “testify to a
possibility rather than a probability.” Turpin, 959 F.2d at 1360. Plaintiffs do not
quantify this possibility, or otherwise indicate how their conclusions about causation
should be weighted, even though the substantive legal standard has always required
proof of causation by a preponderance of the evidence.19 Unlike these experts'
explanation of their methodology, this is not a shortcoming that could be corrected on
remand; plaintiffs' experts could augment their affidavits with independent proof that
their methods were sound, but to augment the substantive testimony as to causation
would require the experts to change their conclusions altogether. Any such tailoring of
the experts' conclusions would, at this stage of the proceedings, fatally undermine any
attempt to show that these findings were “derived by the scientific method.” Plaintiffs'
experts must, therefore, stand by the conclusions they originally proffered, rendering
their testimony inadmissible under the second prong of Fed.R.Evid. 702.
Conclusion