On appeal from Superior Court of New Jersey, Law Division, Bergen County.
Furman, Brody and Scalera. The opinion of the court was delivered by Brody, J.A.D.
[222 NJSuper Page 308] In June 1973, during the first trimester of her pregnancy with the infant plaintiff (plaintiff), plaintiff's mother received an injection of Delalutin, a drug manufactured by defendant to reduce the chance of a threatened miscarriage. The drug had been approved in 1956 by the United States Food and Drug Administration (FDA) to be used for that and other purposes. Delalutin is a synthetic progestin, designed to act like progesterone,
a female hormone that contributes to the expandability of the uterus during pregnancy. Plaintiff was born with an agenesis of the ulna of his left arm, a disabling underdevelopment of the left arm and hand. Plaintiff attributes the birth defect to the Delalutin injection and brought this action in which he alleges negligence and products liability.
After a lengthy trial, the jury answered "no" to the following special interrogatory:
Has it been proved by a preponderance of the credible evidence that Delalutin is defective (that is, that Delalutin causes limb reduction defects of the type sustained by Jeremy Zweig)?
Judgment was accordingly entered for defendant. Plaintiff argues in this appeal that the judge erred by not precluding defendant from arguing the issue that the jury determined because a Utah jury in another case had determined in 1981 that Delalutin caused the kind of defect complained of in this case. Plaintiff also argues that the judge erroneously excluded important evidence and erroneously dismissed his negligence claim.
We deal first with the excluded evidence. As the result of "reports" suggesting an association between intrauterine exposure to female sex hormones and limb reduction defects, the FDA in 1977 directed that progestational agents, such as Delalutin, carry an insert warning to physicians and women that the use of such drugs during the first four months of pregnancy "is not recommended."
In compliance with the FDA directive, defendant's Delalutin insert to physicians states in part, "There is no adequate evidence that [use of progestational agents to treat threatened miscarriage] is effective and there is evidence of potential harm to the fetus when such drugs are given during the first four months of pregnancy."
The Delalutin insert to women states:
There is an increased risk of birth defects in children whose mothers take this drug during the first four months of pregnancy.
Delalutin is similar to the progesterone hormones naturally produced by the body. Progesterone and progesterone-like drugs are used to treat menstrual disorders, to test if the body is producing certain ...