1990 DES Case: Shields v. Eli Lilly & Co.

Abstract

… “Amy Shields filed suit in federal district court against Eli Lilly and Company, alleging that she developed clear-cell vaginal cancer as a result of being exposed to DES while she was a fetus. DES is a medication that was manufactured by Lilly for pregnant women to reduce the risk of miscarriage. The FDA contraindicated DES use in pregnancy in the 1970s after overwhelming evidence linked its use to the development of clear-cell vaginal cancer in women whose mothers received the drug during pregnancy. See Eli Lilly & Co. v. Home Insurance Co.

SHIELDS v. ELI LILLY & CO., Leagle, 19902358895F2d1463_12111, February 16, 1990.

Following discovery, Lilly filed a motion for summary judgment arguing that plaintiff could not prove that she had been exposed to DES. In response, appellant acknowledged that she did not have any direct evidence of exposure to DES. Her mother received medication during the course of her pregnancy but was never told its name. The doctor who prescribed this medication is deceased, and both his prescription records and those of the pharmacy that dispensed the medication have been lost. Nevertheless, appellant proposed to identify the medication as DES, based upon her mother’s physical description of the medication, the circumstances under which it was prescribed, and the professional practice of the doctor who prescribed the medication.

In the summary judgment proceeding, appellant introduced medical records which showed that her mother, Mrs. Shields, experienced a type of bleeding (“staining”) while pregnant with appellant; this condition is typically associated with miscarriages. Mrs. Shields testified that when bed rest did not stop the staining, her physician, Dr. Sinclair, prescribed medication for her. Although Mrs. Shields could not identify the drug by name, she recalled that it came in a small, red pill.

Dr. Sinclair’s nurse, Mrs. Clifford, testified that the doctor sometimes prescribed medication in pill form for patients who were staining or in danger of aborting, and that when he did so, his practice was to prescribe either DES or progesterone. Appellant presented the affidavit of Dr. Linwood Tice, an expert in pharmaceutical history, who stated that although DES came in the form of small red pills, no progesterone commonly and ordinarily on the market in the 1950s met this description.

Finally, appellant introduced the records of several doctors who had examined her. The first examination took place nine years before appellant was ever diagnosed as having cancer. The attending physician, Dr. Isvan Nyrjesy, detected some irregularities in her uterus and on this basis concluded that she had probably been exposed to DES. The following year, appellant was examined by another doctor, Dr. Donald Meek, who also concluded that she had probably been exposed to DES. In 1986, Shields was diagnosed as having “clear cell carcinoma of the vagina,” which her doctor observed was accompanied by “typical DES-associated changes.” Appellant’s tissue samples were submitted to Dr. John Shane, who stated in his affidavit that “such lesions do not occur in the absence of DES exposure … and do not appear in the absence of DES exposure to a statistical certainty of 97% to 99.7%.”

After considering this evidence, the trial court concluded that appellant had not carried her burden of showing sufficient evidence to prove exposure at trial. Accordingly, it granted the summary judgment motion. Appellant challenges this conclusion on the grounds that the trial court imposed an unduly high standard of proof and that, applying the appropriate standard, her offer of proof was sufficient to withstand summary judgment.” …

… continue reading the full paper SHIELDS v. ELI LILLY & CO., on Leagle.

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