ORTHO-GYNOL CONTRACEPTIVE JELLY LABELING WILL BE UNCHANGED in the wake of a Supreme Court ruling to let stand a $4.7 mil. damage award against Ortho for birth defects allegedly caused by the contraceptive. Current labeling for the contraceptive does not warn against birth defects. Ortho maintains that there is no scientific evidence linking Ortho-Gynol to birth defects. FDA's Fertility and Maternal Health Drugs Advisory Committee reviewed safety data on vaginal spermicides at its December 1983 meeting. At that time, the committee concluded that existing evidence did not support a link between fetal abnormalities and use of spermicides, and recommended that the products not be labeled to warn against use during pregnancy. Ortho said the recent damage ruling is the first time the company has been held liable for damages related to its spermicide product. Ortho said three Ortho-Gynol liability cases against the company are currently pending.
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