Lust By and Through Lust v. Merrell Dow Pharmaceuticals, Inc.

Decision Date11 July 1996
Docket NumberNo. 95-55558,95-55558
Citation89 F.3d 594
Parties45 Fed. R. Evid. Serv. 149, Prod.Liab.Rep. (CCH) P 14,674, 96 Cal. Daily Op. Serv. 5160, 96 Daily Journal D.A.R. 8334 Peter Alexander LUST, By and Through Peter LUST, his Guardian ad Litem, Plaintiffs-Appellants, v. MERRELL DOW PHARMACEUTICALS, INC., a corporation; Does 1-20, inclusive, Defendants-Appellees.
CourtU.S. Court of Appeals — Ninth Circuit

Coleen P. Gillespie, Booth, Mitchel & Strange, Los Angeles, California, Terrence J. Mix and Charles D. Sneathern, Redondo Beach, California, for plaintiff-appellant.

Hall R. Marston, Jeffery J. Carlson, George E. Berry, and Charles R. Messer, Dickson, Carlson & Campillo, Santa Monica, California, for defendant-appellee.

Appeal from the United States District Court for the Central District of California, Edward Rafeedie, District Judge, Presiding. D.C. No. CV-93-02590-ER.

Before: FARRIS, FERNANDEZ, and THOMAS, Circuit Judges.

FARRIS, Circuit Judge:

Peter A. Lust brought a personal injury action against Merrell Dow Pharmaceuticals, Inc. alleging that his birth defect, diagnosed as hemifacial microsomia, was caused by his mother's ingestion of Clomid, a fertility drug manufactured by Merrell Dow. California law dictates that causation is a necessary element of a personal injury action. The district court granted summary judgment in favor of Merrell Dow on the grounds that Lust's only causation evidence--the expert opinion of Dr. Alan Done--did not reflect scientific knowledge and was inadmissible under F.R.E. 702. The district court had diversity jurisdiction, 28 U.S.C. § 1332, and we have jurisdiction over the appeal. 28 U.S.C. § 1291. We affirm.

I. Background

The district court held an in limine hearing pursuant to F.R.E. 104(a) to determine whether Done's opinion was admissible under F.R.E. 702. Done explained the reasoning underlying his conclusion that Clomid is a human teratogen (i.e., an agent that causes birth defects) that causes hemifacial microsomia:

... [T]he usual thing is go to human epidemiological studies if they have been done to see whether they support an effect. You also look at animal studies which in and of themselves are not necessarily relevant directly to whether something is a human teratogen, but they are important in the sense that most compounds that are teratogenic in a number of species, say over three, are also going to be teratogenic in humans. You also look for any studies of mutagenicity effect, that is effects on damaging genes that are involved in heredity. And there the reasoning is that there is somewhere between a ninety and ninety-three percent chance that if something causes mutagenicity, it will also cause teratogenicity.

Done found that human epidemiological studies reported a positive association between ingestion of Clomid and a wide variety of birth defects, that animal studies reported Clomid to be teratogenic in four animal species, and that other studies reported Clomid to have a mutagenic affect on humans. He concluded that "since ... Clomid is the known specific drug capable of causing all kinds of birth defects, depending on the timing, it should be able to include [hemifacial microsomia]." He stressed that he had first expressed his theories on Clomid in a 1984 article that predates this litigation.

Merrell Dow elicited a number of concessions from Done on cross-examination. He admitted that he is not a teratologist, geneticist, or embryologist. He admitted that his 1984 article was not peer-reviewed and was based on research conducted in preparation for expert testimony in a different case concerning a different drug manufactured by Merrell Dow. He admitted that no peer-reviewed article concludes that Clomid is a human teratogen. And he admitted that no human epidemiological or animal studies have found a positive association between the ingestion of Clomid and hemifacial microsomia.

Merrell Dow presented its own expert who testified that there were flaws in Done's methodology:

[O]ne of the major principles of teratology is that in response to an exposure to an agent in question, there must be a specific pattern of birth defects in the exposed population. Dr. Done believes that you can get an across the board increase in everything. A little Down syndrome, a club foot, a little spina bifida. That's never been shown with the human teratogen at all. Human teratogens cause specific recognizable patterns of anomalies.

Done responded by pointing to some articles that, he argued, supported his premise that a positive association between an agent and a wide variety of birth defects establishes that the agent substantially increases the probability of all types of birth defects.

The district court excluded Done's testimony. It explained:

The problem in this case is that Dr. Done, despite the fact that he recited the general methodology followed by the scientific community in assessing human teratogenicity, has merely interpreted the work of others, without informing the Court what those works are or what conclusion the original authors reached. Dr. Done has seen fit to "pick and chose" [sic] from the scientific landscape and present the Court with what he believes the final picture looks like. This is hardly scientific.

Since Lust had no causation evidence other than Done's opinion, the district court granted Merrell Dow's motion for summary judgment.

II. Causation

We review a grant of summary judgment de novo, Warren v. City of Carlsbad, 58 F.3d 439, 441 (9th Cir.1995), cert. denied, --- U.S. ----, 116 S.Ct. 1261, 134 L.Ed.2d 209 (1996), and an F.R.E. 702 ruling for an abuse of discretion. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1315 (9th Cir.), cert. denied, --- U.S. ----, 116 S.Ct. 189, 133 L.Ed.2d 126 (1995). The abuse of discretion standard applies to an F.R.E. 702 ruling even though the ruling was dispositive of a motion for summary judgment. See id.; Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 318 (7th Cir.1996).

F.R.E. 702 provides that "[i]f scientific ... knowledge will assist the trier of fact ... to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise." In Daubert v. Merrell Dow Pharmaceuticals, Inc., the Supreme Court held that F.R.E. 702 did not enact Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923), which first stated the rule that expert scientific opinion is inadmissible if it is based on a method that has not gained "general acceptance" in the relevant scientific community. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 587-89, 113 S.Ct. 2786, 2794, 125 L.Ed.2d 469 (1993). Under the Daubert interpretation of F.R.E. 702, general acceptance is not a necessary condition to admissibility; expert scientific opinion is admissible if it qualifies as "scientific knowledge" and is therefore sufficiently "reliable." Id. at 590, 113 S.Ct. at 2794-95.

Daubert maintained that district court judges would continue to act as gatekeepers, and it listed four nonexclusive factors that would assist in the separation of inadmissible opinions based on junk science from admissible opinions developed by the scientific method. District court judges are to consider not only (1) whether the method has gained general acceptance in the relevant scientific community, but also (2) whether the method has been peer-reviewed, (3) whether the method "can be (and has been) tested," and (4) whether there is a "known or potential rate of error." Id. at 594, 113...

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