1971 investigations reported an increased risk of a rare form of vaginal cancer, clear cell adenocarcinomas, in the daughters of women who had taken diethylstilbestrol (DES) to prevent miscarriage. It is estimated that during the over 20 year period that DES was marketed for the prevention of miscarriages, more than 200 companies distributed the drug and that between 500,000 and 2 million pregnant women took the drug, creating between 500,000 and 6 million potential plaintiffs.
The Diethylstilbestrol Dilemma. Who Should Pay? JAMA ;251(24):3228-3229. doi:10.1001/jama.1984.03340480020019, June 22, 1984.
Over 1000 lawsuits have been filed in the US by daughters of women who took DES during their pregnancies and who have actual or potential injuries as a result. Records of the prescribing physicians, pharmacies, and drug companies often have been discarded. The records that are available generally are not helpful because all DES was produced according to a standard chemical formula and frequently was manufactured and prescribed generally. In many of the lawsuits, the plaintiff’s underlying approach has been that DES manufacturers are liable because they failed to test the drug for its long term effects on both mother and child and also failed to warn of these long term effects. The manufactuers’ defense has been that their studies were conducted according to customary practice at the time and there was no reason to suspect that DES would cause cancer in the daughters so many years after the mothers’ injection.
Plaintiffs’ attorneys have applied several unusual theories to the DES problem in attempts to impose joint and several liability on the DES manufacturers as a group, without identifying the particular manufacturer responsible for each plaintiff’s injury. These are reviewed: concerted action; alternative liability; market share; enterprise liability, and the US Food and Drug Administration‘s liability.
There have been mixed results for the injured plaintiffs and the defendant drug manufacturers in the cases that have been tried to conclusion.
- Many courts have dismissed DES suits in which the plaintiffs have been unable to identify the manufacturer, leaving those plaintiffs without a remedy.
- Some courts have allowed suits against one or more drug manufacturers although no evidence exists connecting those defendants to a plaintiff’s injury.
- In most of these cases, the courts have shifted the burden of proof to the defendants to establish they were not the manufacturer of the DES ingested by the plaintiff’s mother.
The courts have assigned responsibility for the DES caused injuries to the drug manufacturers on public policy grounds to provide a remedy for injured plaintiffs who have no other way to obtain redress. Some legal commentators favor a federal legislative scheme to provide compensation to victims of DES and other toxic substances, but there are strong arguments against the broad concept of federal product liability legislation and against the particular bills pending in Congress.