In a precedent-setting decision, the U.S. Supreme Court has upheld a substantial damage award to a young girl whose birth defects were caused by her mother’s use of spermicidal jelly. The decision is said to have alarmed pharmaceutical companies, some of whom are in the courts fighting law suits brought by women injured by various brand-name Inter Uterine Devices (IUDs)

Ortho Pharmaceutical Corporation has been ordered to pay Katie Wells and her parents $4.7 million (U.S) to compensate for pain and suffering and future medical expenses, as well as damages, on the grounds that the company was negligent in not issuing a warning against the possible risks of Ortho-Gynol contraceptive jelly.

Katie’s mother, Mary Maihafer, testified in the lower court hearing that she used the jelly, together with a diaphragm, consistently during the time in which she conceived Katie, and for a short while after. Katie was born with a number of birth defects, mostly abnormalities to her limbs.

Ortho responded that it has sold spermicides since the 1950s and that there are no studies supporting the charge that spermicides cause birth defects. The judge, however, ruled that all the evidence presented proved, to a reasonable degree of medical certainty, that the spermicide caused some or all of the defects

Ortho appealed that judgment, but the U.S. Supreme Court recently upheld the lower court’s decision.

Spermicidal jellies are often recommended for use with diaphragms, sponges and condoms, in order to increase effectiveness against pregnancy. One lawsuit against them will probably not alarm Ortho to the extent of withdrawing its product, it may, however encourage them to publicize the possible side effects – if only to guard against a flood of lawsuits.

Products liability cases are difficult to win, especially in Canada which does not have the history of consumer legal cases that has built up in the U.S. The question unanswered by this case is how many other children have been born with spermicidal-caused birth defects without a connection being made to the product.