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The Dalkon Shield case may turn out to be the worst liability nightmare that a U.S. drugmaker has suffered. The focus of the furor is a nickel-size plastic device that looks like a shield with spikes around the edges. It was developed in 1968 by Hugh Davis, a professor of obstetrics and gynecology at Johns Hopkins University, and Irwin Lerner, an engineer. In 1970 they sold the rights to the invention to Robins, which agreed to pay royalties on future sales and $750,000 in cash. Like other intrauterine devices, the Dalkon Shield was designed to be inserted inside the uterus, where it usually prevented pregnancy by making it difficult for a fertilized egg to attach itself to the wall of the womb. Beginning in 1971 Robins sold 4.5 million Dalkon Shields around the world, including 2.8 million in the U.S.
But the design of the Dalkon Shield was apparently flawed. For one thing, it had a nylon tail that hung through the opening of the uterus so that a doctor could periodically check that the device was still in place. The problem with the tail, some investigators believe, is that it soaked up bacteria from the vagina and allowed the microbes to pass into the uterus. That often caused infection, which sometimes resulted in sterility. In some cases, women became pregnant despite the IUD and suffered miscarriages because of infection. In 1974 Robins suspended sales of the device after receiving evidence that linked the Dalkon Shield to four deaths.
Since then the lawsuits have steadily mounted. So far the company has settled 9,230 cases for $378 million, plus legal expenses of $107 million. Robins' insurer, a unit of Aetna Life & Casualty, has paid much of that money, but the insurance coverage is almost exhausted. More than 5,000 suits are pending, and suits are still being filed at a rate of 371 per month.
Lawyers for the victims contend that Robins knew the Dalkon Shield could be dangerous long before the company stopped selling it. They also complain that Robins refused to alert women who were still wearing the device to have it removed. It was not until last year that the company finally ran full-page newspaper and magazine ads that warned women of the Dalkon Shield's risks and offered to pay the doctor's fee for having it taken out. To this day, though, Robins maintains that the Dalkon Shield is just as safe as any other IUD when properly inserted.
Robins' case suffered a devastating blow last year from Judge Miles Lord of the U.S. district court in Minneapolis. Denouncing Robins for "monstrous mischief" and "corporate irresponsibility at its meanest," the judge ordered a search of the company's files. After combing through documents at Robins' Richmond headquarters, court-appointed officials said they found strong evidence that the company had covered up its knowledge of the Dalkon Shield's dangers. To make matters worse for Robins, Roger Tuttle, a former attorney for the company, testified that he had destroyed internal documents relating to the Dalkon Shield on orders from his bosses. Robins flatly denied Tuttle's testimony, but it helped produce the largest jury verdict against the company to date: a $9.2 million award in May to a Wichita woman who had to undergo a hysterectomy after using the Dalkon Shield.