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Mass Tort Update
DOE vs. ELI LILLY & CO.
Date: June, 1985;
Result: $ 400,000 verdict
State: Washington
Facts: This was a negligence action brought by the 22 year old male plaintiff, who was exposed in-utero to massive doses of the artificial female hormone DES, which was given to the plaintiff's mother throughout the course of her pregnancy and which allegedly caused the plaintiff's genitals to develop improperly. The plaintiff maintained that the defendant manufacturer was negligent in continuing to promote the drug for use by pregnant women when it had knowledge that the drug posed a potential risk to the developing male fetus. The plaintiff further contended that the defendant manufacturer was negligent in failing to warn of the potential risks associated with the drug when used by pregnant women, resulting in the plaintiff mother taking the drug DES throughout the entire course of her pregnancy, which allegedly caused the plaintiff's genitals to develop abnormally. The case was brought against the defendant manufacturer on a negligence theory as a result of the Court's determination that because the plaintiff's mother resided in Virginia at the time she took the drug and because the prescription was filled in Virginia, Virginia law applied. The state of Virginia has not adopted 402A strict liability and, therefore, the plaintiff had the burden of proving actual negligence on the part of the defendant. The plaintiff related that in the 1950's, drug companies were promoting DES for use by pregnant women to prevent spontaneous abortions and, further, that some physicians were prescribing the drug prophylactically to all of their pregnant patients. The plaintiff's mother's treating obstetrician had prescribed DES for her because she had had trouble conceiving. This physician determined, based on the difficulty she had in conceiving, that her pregnancy was a "premium pregnancy," which merited the taking of special precautionary measures to prevent her from losing the pregnancy, including the prophylactic prescribing of DES. The plaintiff related that his mother began ingesting the hormone within her first trimester and continued to take the drug throughout the pregnancy until the birth of the plaintiff. The plaintiff's expert pediatrician who specializes in teratology contended that the defendant manufacturer had knowledge at the time the plaintiff's mother was first prescribed the drug that DES posed a significant health risk to the unborn male fetus of a pregnant woman taking the drug. The plaintiff's expert pediatrician maintained that the defendant had knowledge of animal studies which revealed a link between the administration of DES to pregnant animals and male birth defects in animals. The plaintiff's expert pediatrician further maintained that the defendant had knowledge of human case histories in which male children whose mothers took DES during their pregnancies had been born with birth defects. The plaintiff contended that the defendant was negligent in continuing to promote the use of DES by pregnant women and in failing to warn physicians of the potential risks to the unborn male fetus when used by the pregnant woman in light of the fact that it had knowledge of a link between DES and birth defects. The plaintiff further maintained that as a result of the defendant's negligence in this regard, the plaintiff's mother was prescribed the drug DES and continued to take the drug throughout her pregnancy, which caused the plaintiff's birth defects.
The plaintiff's expert urologist presented epidemiological studies performed at the Univ. of Illinois which indicated that the percentage of birth defects in the population of men whose mothers had ingested DES during their pregnancies was higher than was the percentage of birth defects in the general population which, the plaintiff's expert urologist maintained, established a general causal link between DES ingestion by a pregnant women and male birth defects. The defendant denied that DES causes the type of birth defects suffered by the plaintiff in general and denied specifically that exposure to DES in-utero caused the plaintiff's birth defects. The defendant further denied having knowledge at the time the plaintiff's mother was prescribed the DES hormone of any link between DES and male birth defects. The defendant's expert physician maintained that it was not reasonably foreseeable at the time the plaintiff's mother was taking DES that the drug might cause birth defects in her unborn, developing fetus. This expert related that it is impossible to extrapolate the results of animal studies to human beings and reach any meaningful conclusion and, therefore, at the time the plaintiff's mother was taking the drug, the defendant had acted reasonably in failing to draw any conclusions from the animal studies of which they had been made aware.
The defendant's expert physician further stated that the case histories of birth defects in children of mother's who took DES during their pregnancy, of which the defendant allegedly had knowledge at the time the plaintiff's mother took the drug, were isolated incidents and established no causal linkage between DES and male birth defects at that time. The defendant's expert urologist opined that the epidemiological studies utilized by the plaintiff to support its causation argument were not sufficiently strong to indicate a causal link between DES and birth defects. This expert presented epidemiological studies performed at the Mayo Clinic which he indicated demonstrated that the percentage of birth defects in the population of males whose mothers had taken DES throughout their pregnancies was substantially the same as the percentage of male birth defects in the general population. The defendant's expert obstetrician alternatively maintained that even if the drug did cause the plaintiff's birth defects, the defects were caused by the treating physician's misuse of the drug in the plaintiff's mother's case. The defendant's expert obstetrician contended that the treating physician was negligent in prescribing a different dosage than that which had been recommended by the manufacturer and was negligent in prescribing the drug in her case at all, given the fact that she did not have a prior history of miscarriages or spontaneous abortions.
The plaintiff related that as a result of his in-utero exposure to DES, his genitals failed to develop normally and he was born with a micropenis and undescended nonfunctioning testicles which were subsequently surgically removed. The plaintiff related that as a further result of the in-utero exposure to DES, he developed a hypospadias urinary opening on the underside of the penis which is seen to occur in a middle stage of development between a male and a female. The plaintiff's expert pediatrician explained that in the plaintiff's case, it appeared that some amount of the male hormone had been produced in the beginning stages of development, but that it had been halted at the stage in development during which the plaintiff's mother began taking the DES. The plaintiff related that he underwent a testicular prosthesis implantation procedure and that the hypospadias opening was not surgically corrected because he urinates normally and, therefore, the risks associated with such a corrective procedure would outweigh the benefits to be derived in the plaintiff's case. The plaintiff presently is injected with males hormones on a regular basis. The plaintiff's expert psychiatrist testified as to the profound residual emotional damage suffered as a result of his genital deformities and maintained that the plaintiff will, in all likelihood, never be able to have a sex life due to the permanent emotional and psychological problems resulting from the defects. The jury found for the plaintiff and awarded $ 400,000. The prescribing obstetrician settled out of the case prior to trial for $ 100,000.
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