Appeal from the United States District Court for the Eastern District of Wisconsin. No. 84 C 0288--Terence T. Evans, Judge.
Cudahy, Easterbrook and Kanne, Circuit Judges.
Julie Shirkey, the plaintiff in this diversity action, appeals from a jury verdict in favor of Eli Lilly Company ("Lilly"). Shirkey seeks tort damages under both strict liability and negligence theories as compensation for having contracted clear cell adenocarcinoma of the vagina, a cancer that has been linked to in utero exposure to synthetic estrogen. Shirkey attributes her illness to her mother's ingestion of diethystilbestrol ("DES"), a form of synthetic estrogen marketed as a prescription drug for the prevention of miscarriage and other complications of pregnancy by Lilly and other pharmaceutical companies from 1947 through 1972.
The case went to trial on the liability issue alone with damages issues reserved for later resolution. At the conclusion of the evidence, the district judge read separate instructions to the jury pertaining to negligence and strict liability theories. Responding to a series of special interrogatories, the jury found that Shirkey's mother had ingested DES manufactured by Lilly while pregnant with Julie. The jury also held, however, that Lilly was neither negligent in marketing DES in 1960 nor strictly liable for having marketed a defective product.
On appeal, Shirkey asserts that the district court's jury instructions misstated Wisconsin law. She contends that the district judge should not have instructed the jury that Lilly could be held strictly liable only if it knew or should have known about the dangers of in utero exposure to DES. Shirkey also asserts that the district judge's negligence instruction understated Lilly's duty to potential users by directing the jury to consider the reasonableness of Lilly's failure to foresee the specific harm at issue here--cancer in female offspring--rather than the reasonableness of failing to foresee the possibility of some harm to the offspring of pregnant users. Shirkey also contends that the district judge abused his discretion by excluding two bodies of relevant evidence: depositions from an earlier suit against Lilly taken from an expert who was unable to appear at Shirkey's trial and evidence that DES was ineffective in preventing miscarriages.
We find that Shirkey's challenges to the jury instructions raise issues that lack determinate answers under existing Wisconsin case law. We will therefore certify questions concerning Wisconsin's strict liability and negligence law to the Wisconsin Supreme Court under the mechanism provided by Wisconsin law. See Wis. Stat. §§ 821.01-.12 (1985-86). Since the relevance of the excluded evidence may depend on the correctness of the legal standard that the district court applied, we defer consideration of the evidentiary questions until the Wisconsin Court either clarifies the legal standard or declines our certification and leaves us to anticipate the development of Wisconsin law as best we can.
In 1941, the Food and Drug Administration ("FDA") approved DES for the treatment of a number of gynecological problems unrelated to pregnancy and for the suppression of lactation. In 1947, Lilly submitted a supplemental new drug application to obtain authorization to label and advertise DES as useful in preventing "accidents of pregnancy," principally miscarriages. The application was quickly approved and Lilly, soon to be joined by other manufacturers, began marketing DES for use by pregnant women.
Joanne Shirkey became pregnant with Julie in mid-1960. During the first trimester of her pregnancy, Joanne took 142 tablets of DES in accordance with her doctor's instructions. The jury found that these tablets were manufactured by Lilly. In January 1982, at the age of twenty, Julie Shirkey developed a cancerous lesion on her vagina, diagnosed as clear cell adenocarcinoma. She underwent extensive surgery to arrest the disease.
Shirkey's original complaint, filed in March 1984, alleged that Lilly was negligent in manufacturing and marketing DES for use by pregnant women and that DES was unreasonably dangerous. The complaint was later amended to add allegations that by 1960 Lilly knew that the drug was carcinogenic and ineffective in preventing miscarriages.
The instructions to the jury explained that the strict liability interrogatory would require them to decide
whether the DES ingested by Joanne Shirkey was in a defective condition when it left the possession of the Eli Lilly Company. A pharmaceutical product such as DES is defective if the manufacturer fails to warn the medical profession of dangers it knows about or with reasonable efforts or investigation should know about in relation to the drug. If it knows or should know that the drug is dangerous for certain uses the failure of a drug company to so warn the medical profession renders the drug defective.
Shirkey attacks the district court's strict liability instruction on two grounds. First, she contends that the district judge improperly directed the jury to consider Lilly's conduct rather than to focus exclusively on the nature of its product. Second, Shirkey contends that even if Wisconsin sometimes allows defendants' conduct to enter into determinations of strict liability claims, Lilly's conduct is nevertheless irrelevant in this case because DES, as marketed for use by pregnant women, was an "unreasonably dangerous" product for which the producer is strictly liable regardless of what was known or practically knowable at the time it was sold. See ...