In a products liability case based on allegations that in utero exposure to diethylstilbestrol (DES) caused infertility in the daughter, what level of proof is required to establish which pharmaceutical firm manufactured the medication that the mother consumed?
A female plaintiff filed suit against a major pharmaceutical manufacturer in the US District Court for the District of Columbia alleging that she had suffered the damages described above because her mother had been prescribed and had consumed DES while pregnant during 1964-1965. The medication had been dispensed in a midwestern state; the lawsuit was filed where the daughter now resided some 40 years later. The case was in federal court because the plaintiff and the defendant-manufacturer were in different states.
The key issue for the trial court was whether the plaintiff had presented sufficient evidence that the brand of DES consumed by the mother was manufactured by the firm being sued in this case. At the conclusion of the pretrial discovery phase of the proceeding and before the trial began, the manufacturer-defendant made a motion to the trial court judge to dismiss the case, because the plaintiff had not presented sufficient evidence to establish that this firm had been the source of the medication allegedly causing the injury. The standard applied by the court in such a case is whether the medication consumed by the mother was more likely than not manufactured by the defendant firm. The trial court judge ruled that the plaintiff had not met this standard, and, as a result, the case was dismissed.
The plaintiff?s evidence on the source of the product dispensed 4 decades earlier was twofold: (1) the mother?s description of the appearance of the medication she consumed, and (2) the statement of a pharmacist at the pharmacy where the medication had been dispensed that the only brand in stock was that produced by the defendantmanufacturer. The manufacturer counterargued that the mother?s description of the appearance of the dosage form was insufficiently specific, because the appearance she described also fit 2 other DES producers? products on the market at the time. With regard to the testimony of the pharmacist, the manufacturer was able to establish that he had not started working at the pharmacy until 2 years after the mother received her medication there.
The plaintiff?s attorneys attempted to introduce supplemental affidavits related to those 2 arguments by the manufacturer, but the trial court judge would not allow that. The judge ruled that, if that were permitted, that would constitute ?recalibration? of the original arguments.
The trial court judge granted the summary judgment motion of the defendant because the plaintiff had failed to meet the burden of proof required to proceed to trial. After having her case dismissed at the trial court level, the daughter appealed to the US Court of Appeals for the District of Columbia Circuit, the relevant federal appeals court. The arguments on appeal were that the trial court judge had erred in not permitting use of the supplemental affidavits and that the ruling giving a summary judgment to the defendant was also in error.
The Court of Appeals agreed with the trial court judge. The summary judgment in favor of the defendant-manufacturer had been properly decided.
The evidence presented regarding the appearance of the medication actually consumed was not sufficiently specific to rule out that the product of another manufacturer had indeed been dispensed.
The mother?s description of the tablet also fit the products of another manufacturer at that time.
The testimony of the pharmacist who joined the pharmacy 2 years after the dispensing of the medication in question was characterized as ?inadmissible hearsay,? because he had no firsthand knowledge of what brand of DES was in the pharmacy?s inventory 2 years before he started there. Any information that he had about the brand of DES used in the pharmacy would have been what he was told by others (ie, hearsay?he heard it from them and was now saying it as the truth).
This case is a good example of what is known in the liability insurance industry as the long-tail effect (ie, a claim is pursued many years after the event that gave rise to the damages). This phenomenon has led to a major shift in the way professional liability insurance policies have been written since the medical malpractice crisis of the 1970s, because insurers were having difficulty projecting their potential financial exposure for claims filed long after an event. It also brings to mind a case in California where DES manufacturers were held collectively liable when the plaintiff could not identify which specific firm made the product actually consumed?a rule in the law known as enterprise liability.
Get to know RESPIMAT, the slow-moving mist inhaler from Boehringer Ingelheim Pharmaceuticals, Inc.
Watch the RESPIMAT video and test your knowledge with a short multiple-choice quiz. When you get all the answers right, you’ll receive a certificate naming you a RESPIMAT T.O.P. Performer. Why not check it out today?
Clinical features with downloadable PDFs