Monday, May. 09, 1977

Taking DES to Court

When a team of Massachusetts General Hospital physicians discovered evidence of a link between a certain type of vaginal cancer and a synthetic estrogen widely taken by pregnant women over two decades, it was obvious that medicine had created a hormonal time bomb. The cancer showed up not in the women who had used diethylstilbestrol, or DES, but in their daughters--some 15 or 20 years after birth. Their sons are apparently not threatened by cancer, but there are indications that in some cases they may also be affected--by genital deformities or sterility. By 1971, when the federal Food and Drug Administration warned physicians against prescribing DES to prevent miscarriage, perhaps as many as 2 million women had taken the drug.

It is now clear that DES created a legal time bomb as well. Billions of dollars worth of damage suits against drug companies (and in a few cases against hospitals and physicians) have already been filed by apparent DES victims and their relatives. Last week former U.S. Representative Patsy T. Mink of Hawaii, now an Assistant Secretary of State, announced that she was seeking $77.7 million for herself and 1,080 other women she says were subjected to DES in a 1951-52 clinical study.

Vitamin Pills. Receiving prenatal care at the Chicago Lying-in Hospital in late 1951 and early 1952, the women were given unmarked tablets as part of a study conducted by the late Dr. William Dieckmann. Though Dieckmann's tests actually showed the estrogenic hormone to be of no particular value in combatting miscarriages, DES continued to be prescribed until the FDA notice. Mink claims she was told that the pills were vitamins, and was not officially notified of the DES project by Chicago authorities until February 1976. She then rushed her daughter Gwendolyn, 23, to a doctor and discovered that she was afflicted with a condition known as adenosis, an abnormal cell formation also tied to DES offspring, and sometimes a precursor of cancer. Mink is especially angry that nobody notified her about the experiment. "There's no way we could know," she says. "That's the outrage."

The drug companies declare that the medication was effective in its basic purpose--combatting miscarriage--and that clear-cell adenocarcinoma, a cancer of the vagina or cervix, appears naturally in the population as a whole. In addition, according to one drug-company lawyer, the DES lawsuits have "many persnickety permutations." Although thousands of young women whose mothers took DES have developed the adenosis formation, so far fewer than 200 of them are known to be suffering from the cancer. One of the first legal complications for most victims in suing, however, is the difficulty in linking an individual pill user with a particular drug company. The drug was never patented, but was sold under its generic name by a number of different companies. Because pharmacy and physician records cannot be located after so many years, it is impossible in many cases to pinpoint liability.

A major breakthrough on that point may come soon in a Detroit case. Michigan Judge Thomas Roumell is considering whether to allow 184 daughters of DES users to sue 16 drug manufacturers as a group, using the theory that they were all engaged in a concerted enterprise and were thus all responsible. This legal theory is a modification of enterprise liability, successfully used in a 1972 dynamite blasting-cap case, where it proved impossible to fault a specific manufacturer. If Judge Roumell accepts the group-suit theory and he is upheld on appeal, the drug companies may be forced to combine resources to finance settlements and perhaps treatment of DES victims. In any case, U.S. courts may well be bombarded with DES lawsuits for the next ten years or more.

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