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SRA
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Casebook, First Edition, July 1999 Ambrosini v. Labarraque: Admitting Animal and Cell Evidence Would chemical in vitro cell studies and in vivo animal studies be insufficient, in all cases, to support a conclusion that a particular drug caused birth defects? Several federal appellate courts in recent years have asserted that animal studies, in certain circumstances, may be admissible in toxic tort litigation. In 1992, the D.C. Circuit Court of Appeals in Ambrosini v. Labarraque, 966 F.2d 1464 (D.C. Cir. 1992), emphasized that Richardson v. Richardson-Merrell, Inc., 857 F.2 823 (D.C. Cir. 1988), did not hold that in vitro and in vivo studies always would be insufficient to support a finding that a particular drug is a human teratogen. The defendants in Ambrosini sought to rely on Richardson. That court found that cell and animal studies alone, in conflict with published epidemiological studies, and supported only by unpublished, reanalyzed epidemiological data offered by the plaintiff's expert, could not form an adequate basis for an expert opinion that a drug caused the plaintiff's birth defects. The Richardson plaintiff's own expert had acknowledged that data underlying his opinion were not of a type reasonably relied on by experts in the field. The Ambrosini decision by Appeals Court Chief Judge Mikva appears not to preclude the use of animal and cell studies as a partial basis for an inference of causation in a toxic injury case where those study findings reinforce the human (epidemiological) data. A plaintiff's expert had offered epidemiological evidence that a class of drugs including the suspect drug, in general, do cause birth defects. But the lower court found this unexamined evidence to be inadmissible after reviewing an affidavit of a defendants' expert that relied on several negative epidemiological studies. In reversing the district court's grant of summary judgment in favor of the drug manufacturer and plaintiff's physician, and in distinguishing between Ambrosini and Richardson, the Court of Appeals declared:
The use of animal evidence is well established in setting public health policy and developing regulatory standards from probabilistic data on population risk, but there is presently no such acceptance in determining the scientific basis for personal risk and individual causation. This case contributes to the future possibility that health risk assessments relying partially or even heavily on animal and cell data will be found admissible in toxic injury lawsuits. [Contributed by Wayne Roth-Nelson] CLASSIFICATION: CIVIL LITIGATION; TOXIC CHEMICAL INJURY; ADMISSIBILITY OF EVIDENCE FOR CAUSATION |
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