Dalkon Shield

The Dalkon Shield was an intrauterine birth control device (IUD) manufactured and sold from January 1971 to October 1974 by the A. H. Robins Company, maker of Robitussin cough syrup and Chapstick lip balm. Sales were suspended at the request of the Food and Drug Administration (FDA) because of a high number of reported incidents of inflammatory pelvic infections and spontaneous septic abortions as well as four deaths. Also, many children were born with defects linked to the device. In 1985, after 9,500 cases had been litigated or settled, the company filed for bankruptcy and set up a $2.3 billion fixed-asset trust fund to deal with the thousands of pending cases.

The Shield was invented by Dr. Hugh Davis and Irwin Lerner in 1968. After promoting the device at medical meetings, they named their company Dalkon Corporation. Dr. Davis published an article in the February 1, 1970, issue of the American Journal of Obstetrics and Gynecology that described a study of 640 women using the Dalkon Shield with a pregnancy rate of 1.1%. The article also described the device as “modern,” having “superior performance,” and being a “first choice method,” words not normally used in a rigorous scientific study. He also neglected to say that he was the inventor. A. H. Robins bought the manufacturing rights in June 1969 for royalties and $750,000, hired Davis as a consultant, and modified the design, adding a small amount of copper and a multifilament wick. They also made a smaller version.

At the time, there were more than 70 IUDs on the market, so Robins began an aggressive marketing campaign to doctors and clinics, touting the device as safer, easier, and more painless to insert, and having the lowest pregnancy rate. They also used Davis's article as a marketing tool, without disclosing his ties to the company. Because the Shield was a device and not a drug, it was not subject to the extensive testing required by the FDA. Problems began in 1971 with patients becoming infected and/or pregnant. By June 1974, there had been four deaths linked to the Shield as well as countless spontaneous abortions and pelvic infections leading to continuous pain and sometimes sterility. Many studies showed that the pregnancy rate was much higher than originally thought, some showing it at 5.5% or even higher. The FDA requested that it be taken off the market. In the United States, 2.2 million devices had been sold; global sales were 4.5 million. Sales continued in foreign countries for another 9 months.

Court records of litigated cases showed inadequate testing, false claims about both safety and rate of pregnancy, and a high incidence of pelvic infections and other complications. Robins's first response was to blame the doctors for improper insertion. Aetna, their liability insurer, cut off coverage in February 1978. One of the cases was in 1984 in Minnesota, where Judge Miles Lord, after taking a deposition from company officials, castigated them for defending rather than recalling the Dalkon Shield. His remarks were later struck from the record, but his statements were widely publicized and encouraged more victims to sue the company. In October 1984, Robins voluntarily withdrew the Dalkon Shield from the market and, the following February, launched an advertising campaign urging women still wearing Shields to have them removed at the company's expense. By the end of March, 4,437 women had complied and filed claims for [Page 544]removal expenses. That year, Robins filed for Chapter 11 reorganization, which prevented more lawsuits. Part of the plan was to consolidate all future claims in a trust fund following the precedent of Johns-Manville.

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