The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of women, which eventually led to numerous lawsuits, in which juries awarded millions of dollars in compensatory and punitive damages. History Hugh J. Davis, M.D., a physician, and Irwin Lerner, an electrical engineer, invented and applied for a patent for the Dalkon Shield in 1968. In 1970, the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Davis. The Dalkon Corporation had only four shareholders: the inventors Davis and Lerner, their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In January 1971, Dalkon Shield went into the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield in the U.S. At the time of its introduction, the Dalkon Shield was promoted as a safer alternative compared to birth control pills, which at the time were the subject of many safety concerns. Dr. Davis himself was a participant in the 1970 Nelson hearings, which were congressional hearings led by Senator Gaylord Nelson regarding the safety of oral contraceptives. He asserted that oral contraceptives with high doses of hormones were dangerous and that the efficacy of the pill was "greatly overrated." Design flaw A string composed of hundreds of nylon monofilaments enclosed within a nylon sheath was tied to the Dalkon Shield. The string tended to harbor bacteria and to deteriorate inside the body; it conducted bacteria through the cervix into the uterus, bypassing the cervical mucus which normally acts as a barrier against infection. Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer, but failed to detect the tendency of the device to cause septic abortion and other severe infections. Infections In June 1973, the Centers for Disease Control and Prevention (CDC) conducted a survey of 34,544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to the use of an IUD in the previous 6 months. A total of 16,994 physicians responded, yielding 3,502 unique case reports of women hospitalized in