IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF CALIFORNIA

WILLIAM DAUBERT, et al., Plaintiffs ,
V.
MERRELL DOW PHARMACEUTICALS, INC.. et al.,..Defendants.

AND

MICHAEL SCHULLER et al., Plaintiffs ,
V.
MERRELL DOW PHARMACEUTICALS, INC.. et al.,..Defendants.

MEMORANDUM AND DECISION ORDER
EARL B. GILLIAM, UNITED STATES DISTRICT JUDGE

Having considered the points and authorities and oral argument of counsel, the court issues this memorandum decision and order granting defendant's motion for summary judgment.

FACTS

This case involves personal injuries sustained by plaintiffs. Infant plaintiffs and their guardians ad litem seek damages from defendant for injuries (limb reduction birth defects) allegedly sustained as a result of the mothers' ingestion of Bendectin during pregnancy. Bendectin is a prescription pharmaceutical product previously manufactured by Merrell Dow, indicated solely for the treatment of nausea and vomiting during pregnancy. Defendant has moved for summary judgment, arguing that plaintiffs have failed to sustain their burden of establishing a genuine issue of material fact regarding causation.

DISCUSSION

In this case the defendant has moved for summary judgement and Plaintiffs, who have the burden of proof by a preponderance of the evidence, oppose the motion. The court must therefore determine 'whether a fair-minded jury could return a verdict for the plaintiff [based] on the evidence presented.'

There are two schools of thought governing expert testimony in these Bendectin cases, and one seems to be prevailing- in the federal courts. Unfortunately for the plaintiffs, the prevailing school of thought warrants summary judgment in this case.

The prevailing school is best exemplified by Brock, where the court held "that failure to present statistically significant epidemiological proof that Bendectin causes limb reduction defects to be fatal to their case."

In medical cases like this one, courts must 'critically evaluate the reasoning process by which the experts connect data to their conclusions in order for courts to consistently and rationally resolve the disputes before them.' Absent a scientific understanding of the cause of the birth defects at issue in Bendectin cases, causation my be shown only through reliance upon epidemiological evidence.

In Richardson, Dr. Done, the plaintiff’s expert, relied upon 1) chemical structure activity analysis, 2) in vitro (test tube) studies, 3) in vivo (animal teratology) studies, and 4) reanalysis of epidemiology studies. He used the results of these four types of studies to conclude that within a reasonable degree of certainty, Bendectin causes birth defects. The court concluded that Dr. Done's testimony lacked an adequate scientific basis:

In this case, the plaintiffs offer the opinion testimony of eight experts to establish that Bendectin is teratogen (it causes limb reduction defects generally), and that Bendectin ingested by the mothers during pregnancy caused the limb reduction defects suffered by the infant Daubert and Schuller plaintiffs. Plaintiffs have submitted this testimony in the form of affidavits, deposition transcripts, and transcripts from previous trials.

The federal courts have held that epidemiological studies are the most reliable evidence of causation in this area. Accordingly, expert opinion which is not based on epidemiological evidence is not admissible to establish causation because it lacks the sufficient foundation necessary under FRE 703. Therefore, expert testimony concluding that Bendectin causes limb reduction defects which is based upon in vitro-generally studies, chemical structure analyses and animal studies is insufficient to take the issue to the jury. The plaintiffs' experts must be competent to testify that some epidemiological study or recalculation shows a statistically significant relationship between the ingestion of Bendectin and birth defects and that this study forms the basis of their opinion. In this case, the plaintiffs have failed to live up to this mandate to support their claim that Bendectin is a teratogen. … The plaintiffs’ experts agree that none of the published studies show a statistically significant association between the use of Bendectin and birth defects.

The plaintiffs argue that the absence of statistically significant epidemiological studies does not disprove the fact that Bendectin causes limb reduction defects. However, the plaintiffs have the burden of proof, and they must come forward with statistically significant epidemiological evidence. The plaintiffs claim that Dr. Gross performed a new epidemiological study on Bendectin, but this is false. He simply recalculated a previously published study and tried to show that there actually was a significant relation between Bendectin and birth defects. Dr. Gross' 'study' was apparently never published or subjected to peer review, and nowhere does it state that Bendectin sales increased the relative risk of limb reduction defects to a level significantly above 1.0 with a confidence interval that did not include unity. Dr. Gross alleges that this 'study' shows 'a statistically significant association that is highly significant, but his allegation and this evidence is insufficient to take this matter to a jury.

The court feels that the strongest inference to be drawn for plaintiffs based on the epidemiological evidence is that Bendectin could possibly have caused plaintiffs' injuries, therefore summary judgement is proper against them. The court finds that there are no genuine issues of material fact with respect to causation and finds for the defendant on all causes of action.

IT IS SO ORDERED. Dated: November 1, 1989