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AAP News Vol. 3 No. 8 August 1987, p. 3 © 1987 American Academy of Pediatrics
Case 1. A newborn with cleft lip and limb abnormalities was born to a 27-year-old mother. In searching for an explanation, Ms. W.recalled having used vaginal spermicides during the first four weeks after conception. Consequently, she sued the Ortho Pharmaceutical Corporation alleging that the malformations were caused by the spermicide. As might be predicted, "expert witness testimony" supported that contention despite the "overwhelming" evidence that such spermicides are not teratogenic. Teratologists, epidemiologists, representatives from the National Institutes of Health and other witnesses testified for the defense. Still others stressed that the Food and Drug Administration, the federal government's policy-maker on the subject, had concluded that there was not enough evidence to require a warning about the possibility of fetal risk on the label of the spermicides in question.
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