43 Years Later, a DES Case Is Still in the Court System

Pharmacy Times, Volume 0, 0

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

In a products liability case based onallegations that in utero exposure todiethylstilbestrol (DES) caused infertilityin the daughter, what level of proof isrequired to establish which pharmaceuticalfirm manufactured the medicationthat the mother consumed?

Facts of the Case

A female plaintiff filed suit against amajor pharmaceutical manufacturer inthe US District Court for the District ofColumbia alleging that she had sufferedthe damages described above becauseher mother had been prescribed and hadconsumed DES while pregnant during1964-1965. The medication had been dispensedin a midwestern state; the lawsuitwas filed where the daughter nowresided some 40 years later. The casewas in federal court because the plaintiffand the defendant-manufacturer were indifferent states.

The key issue for the trial court waswhether the plaintiff had presented sufficientevidence that the brand of DES consumedby the mother was manufacturedby the firm being sued in this case. At theconclusion of the pretrial discoveryphase of the proceeding and before thetrial began, the manufacturer-defendantmade a motion to the trial court judge todismiss the case, because the plaintiffhad not presented sufficient evidence toestablish that this firm had been thesource of the medication allegedly causingthe injury. The standard applied bythe court in such a case is whether themedication consumed by the motherwas more likely than not manufacturedby the defendant firm. The trial courtjudge ruled that the plaintiff had not metthis standard, and, as a result, the casewas dismissed.

The plaintiff?s evidence on the sourceof the product dispensed 4 decades earlierwas twofold: (1) the mother?sdescription of the appearance of themedication she consumed, and (2) thestatement of a pharmacist at the pharmacywhere the medication had beendispensed that the only brand in stockwas that produced by the defendantmanufacturer.The manufacturer counterarguedthat the mother?s descriptionof the appearance of the dosage formwas insufficiently specific, because theappearance she described also fit 2 otherDES producers? products on the marketat the time. With regard to the testimonyof the pharmacist, the manufacturer wasable to establish that he had not startedworking at the pharmacy until 2 yearsafter the mother received her medicationthere.

The plaintiff?s attorneys attempted tointroduce supplemental affidavits relatedto those 2 arguments by the manufacturer,but the trial court judge would notallow that. The judge ruled that, if thatwere permitted, that would constitute?recalibration? of the original arguments.

The trial court judge granted the summaryjudgment motion of the defendantbecause the plaintiff had failed to meetthe burden of proof required to proceedto trial. After having her case dismissedat the trial court level, the daughterappealed to the US Court of Appeals forthe District of Columbia Circuit, the relevantfederal appeals court. The argumentson appeal were that the trial courtjudge had erred in not permitting use ofthe supplemental affidavits and that theruling giving a summary judgment to thedefendant was also in error.

The Court?s Ruling

The Court of Appeals agreed with thetrial court judge. The summary judgmentin favor of the defendant-manufacturerhad been properly decided.

The Court?s Reasoning

The evidence presented regarding theappearance of the medication actuallyconsumed was not sufficiently specificto rule out that the product of anothermanufacturer had indeed been dispensed.

The mother?s description of the tabletalso fit the products of another manufacturerat that time.

The testimony of the pharmacist whojoined the pharmacy 2 years after thedispensing of the medication in questionwas characterized as ?inadmissiblehearsay,? because he had no firsthandknowledge of what brand of DES was inthe pharmacy?s inventory 2 years beforehe started there. Any information that hehad about the brand of DES used in thepharmacy would have been what he wastold by others (ie, hearsay?he heard itfrom them and was now saying it as thetruth).

This case is a good example of what isknown in the liability insurance industryas the long-tail effect (ie, a claim is pursuedmany years after the event thatgave rise to the damages). This phenomenonhas led to a major shift in the wayprofessional liability insurance policieshave been written since the medical malpracticecrisis of the 1970s, becauseinsurers were having difficulty projectingtheir potential financial exposure forclaims filed long after an event. It alsobrings to mind a case in California whereDES manufacturers were held collectivelyliable when the plaintiff could not identifywhich specific firm made the productactually consumed?a rule in the lawknown as enterprise liability.