Lawyers Crank Up the Wayback Machine to Fight Over DES, an Old Miscarriage Drug

Last Updated Apr 29, 2010 1:29 PM EDT

A group of women suing Abbott Labs (ABT) and a dozen other companies over a drug their mothers took to prevent miscarriages will require both sides to reach back as far as the 1930s for their evidence. It's not clear whether that evidence still exists, but the case promises to provide an interesting history of drug development in the days before the FDA existed. The women claim the companies misled the FDA into approving the drug, estrogen diethylstilbestrol (DES), even though they had not actually tested it on pregnant women. The FDA, however, wasn't given full authority to regulate drugs until 1938. The plaintiffs allege that the drug was developed in the 1930s and approved by the FDA sometime "in and about 1940" (their complaint is slim on details). So even if the evidence exists, the timeline is tight if they are to prove that the FDA was indeed misled. The defendants have denied all the claims.

Regardless of its merits, the case is a reminder to healthcare managers that their customers' health waxes and wanes for a full generation after the sale of the product has been recorded. If the case proceeds, it will also be an interesting test of companies' record-keeping policies. Many companies warehouse old documents for several years before allowing them to be destroyed. But should drug companies be required to keep paperwork for 60 years or more, just in case someone sues?

Companies that, over the decades were acquired or merged with Eli Lilly (LLY), Merck (MRK), Johnson & Johnson (JNJ) and Pfizer (PFE) are named as defendants. One of the defendants is "E.R. Squibb & Sons," the 1895 company founded by Edward Robinson Squibb (pictured, top and right, in his lab in 1858) that later became Bristol-Myers Squibb (BMY).

The women, who were all born between 1957 and 1971, claim that their mother's ingestion of DES exposed them to the chemical in utero, and has put them at "extremely high risk for experiencing certain cancers, infertility, ectopic pregnancies as well as other serious injuries."

Images: From Bristol-Myers Squibb.

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