Case Evaluation

: Castrignano v. E.R. Squibb & Son

CASTRIGNANO vs. E.R. SQUIBB & SON

Date: September 17, 1986;

Result: $ 400,000 Verdict

State: Rhode Island

Facts: This was a products liability action brought by the female plaintiff, who was in her early 30's, against the defendant pharmaceutical company, E.R. Squibb & Son, in which it was contended that the defendant manufactured and marketed an unreasonably Dangerous Drug, diethylstilbestrol, which is commonly known as DES, for use by pregnant women without adequate warnings to prospective users and to the medical profession regarding possible harmful side effects of the drug. As a result, the plaintiff's mother was prescribed and administered DES during her pregnancy with the plaintiff, which caused the female plaintiff to be born with serious birth defects, including vaginal adenosis and an incomplete cervix.

The plaintiff contended that her physical problems have resulted in four miscarriages, necessitating the performance of a cerclage procedure, involving the placing of a band around her cervix to enable her to carry a pregnancy to term, and further resulted in emotional problems and an inability to perform sexually. The evidence indicated that in 1953, while the plaintiff was in-utero, her mother had ingested DES, which had been prescribed prophylactically by her treating obstetrician and which was taken on a daily basis. The plaintiff presented evidence that during this time period, although it was not the standard, certain physicians were prescribing the drug, either prophylactically, or for high-risk patients to prevent or lessen the chances of miscarriage. The plaintiff appeared to be completely normal at birth, but in 1975, she began complaining of gynecological problems.

The evidence indicated that in 1978, her treating physicians began to suspect that her problems might be the result of DES exposure in-utero. In 1980, a definitive diagnosis of vaginitis adiposis and an incomplete cervix was rendered. The plaintiff thereafter became pregnant and was successful in carrying her first pregnancy to term. Following the birth of her first child, the plaintiff suffered four subsequent miscarriages which, she contended, were related to an incompetent cervix, resulting from DES exposure in utero. The plaintiff thereafter underwent a cerclage procedure, which involved the placing of a band around the cervix for support. This enabled her to carry another pregnancy to term. The plaintiff's treating psychiatrist's reports on the plaintiff were read into evidence. The psychiatrist described the severe emotional problems suffered by the plaintiff as a result of her physical problems, including depression and an inability to perform sexually, which had a tremendous detrimental effect on the plaintiff's marriage. The plaintiff testified that her emotional problems were so severe that she remained a virgin for the first five months of her marriage.

The plaintiff's expert ob/gyns maintained, based upon the medical information available to the defendant, that in 1953 it was reasonably foreseeable that DES posed a potential health hazard to the developing fetus when ingested by the pregnant mother. The plaintiff's expert pharmacologist cited certain animal studies which had been performed on DES prior to 1953 and which were available to the defendant in 1953, which indicated a potential relationship between birth defects and DES. The plaintiff's experts maintained that such information should have prompted the defendant to perform testing of the subject drug for fetal side effects and should have prompted the defendant to apprise the prospective users and the medical community of the potential risks of the drug.

The plaintiff's experts additionally related that the results of the Deekman study, which was performed in Chicago around the 1953 time period, indicated that DES was not effective in preventing miscarriages. The plaintiff maintained that the medical community should also have been apprised of this information. The defendant denied that it had possessed adequate information in 1953 regarding potential harmful side effects of DES which should have prompted them to begin testing the product for fetal abnormalities associated with the product's use and contended that the warnings provided in the accompanying literature were adequate based upon the information available at the time. The defendant's experts contended that the plaintiff's physical problems could have resulted from other causes and that the plaintiff had not sufficiently established that DES was the cause of her condition. The plaintiff elicited countering testimony from her mother who related that she had not taken any other medications throughout her pregnancy with the plaintiff, nor did the plaintiff have a family history of congenital abnormalities.

The plaintiff's expert ob/gyns further countered that the symptoms exhibited by the plaintiff were absolutely consistent with DES exposure in-utero. The plaintiff claimed damages for the pain and suffering concomitant with the four miscarriages and subsequent surgery which she contended were the direct result of DES exposure. The plaintiff further claimed damages for emotional distress, which adversely affected her marriage and her mental well-being and which necessitated extensive psychiatric treatment. The jury found for the plaintiff on the strict liability and breach of warranty counts and exonerated the defendant on the negligence count. The jury awarded the plaintiff $ 400,000 in compensatory damages plus prejudgment interest.

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