Eli Lilly

SINCE THE 1970s, this pharmaceutical manufacturer has been hit with hundreds of lawsuits arguing that the company failed to disclose risks associated with four substances: diethylstilbestrol (DES), a synthetic estrogen widely used to prevent miscarriages; Oraflex, an anti-inflammatory; Prozac, the popular antidepressant; and thimerosal, a preservative used in vaccines. Of the drugs that Lilly may have marketed without proper research or disclosure, DES has caused the most pervasive and best documented harms. The Centers for Disease Control and Prevention (CDC) estimate that 5 to 10 million people are at risk from side effects from DES, many of them children or grandchildren of women who were prescribed the drug.

First synthesized in 1938 by Edward Charles Dodds, DES was embraced by researchers as a less expensive, more potent substitute for natural estrogen, potentially able to cure a variety of female reproductive ailments. Colleagues recall Dodds consulting for Lilly in the 1930s, says investigative journalist Robert Meyers, but Lilly attorneys deny the researcher was ever on the payroll. Since Dodds refused to seek a patent, Lilly was only one of over 250 companies that would make or market the drug.

Dr. Don Carlos Hines recalled later, in testimony prepared for Lilly's defense, that in December 1940 he joined with representatives from three other major pharmaceutical companies to pool their research in support of Food and Drug Administration (FDA) approval for DES. Hines also insisted that results from animal testing, which showed that DES caused cancer and reproductive abnormalities, could not be generalized to humans.

In 1979, a New York jury disagreed, awarding Joyce Bichler, whose mother had been prescribed DES while pregnant, $500,000 in civil damages. The jury found that Lilly had coordinated with other drug manufacturers to avoid doing proper testing, and that a prudent manufacturer would never have brought the product to market if testing had been done.

Bichler was one of a number of women, all exposed in the womb to DES, who in their teens or early 20s developed a rare form of vaginal cancer, clear-cell adenocarcinoma. A pattern of this disease, formerly seen only in post-menopausal women, was noticed in the late 1960s by Dr. Howard Ulfelder of Massachusetts General Hospital. Researchers later found that “DES daughters” also face higher risks for reproductive tract abnormalities, ectopic pregnancies, and infertility. Problems found in “DES sons” include genital abnormalities and a higher rate of noncancerous[Page 278] cysts on the testicles. Women who took DES may face higher breast cancer risks.

Meyers notes that Lilly's salespeople were actively promoting DES to doctors and pharmacists even before it was approved by the FDA. Among the research omitted from later DES promotional brochures was a study, conducted from 1950 to 1952 at the Chicago Lying-In Hospital, that found DES not only failed to prevent miscarriages but seemed to cause them. Lilly did not fund its own research on DES effects until after the FDA banned the drug in 1971.

The company did fund research on anti-arthritis drug Oraflex, approved by the FDA in 1982. However, they did not disclose to the FDA that the drug could cause liver or kidney damage in elderly patients, despite reported fatalities in the United Kingdom and Denmark. Available for just three months in the United States, Oraflex is believed to have caused 26 deaths and 200 cases of non-fatal organ failure. In August 1985, Lilly pled guilty to 25 misdemeanor counts of withholding information and mislabeling, paying $1,000 per count. The sole civil judgment against Lilly was secretly settled during the appeals process.

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