A. H. Robins

IN 1997, more than 25 years after A. H. Robins in-troduced the Dalkon Shield intrauterine device (IUD) as a safe, effective contraceptive, the last of the product liability suits against the company were headed for court. In the intervening years, at least 20 deaths and 200 miscarriages had been caused by the Dalkon Shield; 235,000 women attributed pelvic infections, often leading to infertility, to their use of the product. The Shield had been on the market in the United States for less than four years, from January 1971 to June 1974.

Marketed by A. H. Robins as a safer, more effective alternative to oral contraceptives, the Dalkon Shield was essentially an untested device with unknown effects. At the time, the U.S. Food and Drug Administration (FDA) required advance testing and approval only for drugs, not for medical devices. Since IUDs are presumed to work by irritating the uterus in a woman, thus preventing fertilized eggs from implanting there, they qualified as contraceptive devices.

Although A. H. Robins included copper in the Dalkon Shield in hope of an additional contraceptive effect, and mentioned this in their marketing to doctors, the company downplayed the importance of the copper in its reports to the FDA so that the Shield would not be reclassified as a drug.

Such testing as the company relied upon was inadequate and misrepresented. The original clinical trial by Dr. Hugh Davis, inventor of the Shield and shareholder in the Dalkon Company bought by Robins, claimed a 1.1 percent pregnancy rate, with few side effects or spontaneous rejections of the Shield. Later reviews of Davis's study argued that his testing period was insufficient, his sample too small, and his procedures gravely flawed. The Shield was also significantly redesigned by A. H. Robins, making Davis's results meaningless. Results from a later 10-clinic study, touted by A. H. Robins as the “Cadillac” of clinical studies, were largely concealed from the public. In an internal company report quoted by Minneapolis, Minnesota, investigative reporters Susan Perry and Jim Dawson, project coordinator Dr. Ellen Preston noted that studies would be funded only if they were “known in advance to be favorable.” Lacking such studies, Robins continued to use the 1.1 percent figure in its marketing, even though independent researchers put the pregnancy rate as high as 5 percent and argued that the Shield's rejection rate and side effects were worse than those of other IUDs.

The falsely low pregnancy rate attributed to the Shield left doctors and patients unprepared for the device's high risk of a second-trimester septic abortion. A. H. Robins initially instructed doctors not to remove the Shield from women who became [Page 2]pregnant, as attempting to remove the device was likely to cause a miscarriage. However, doctors discovered that leaving it in almost always led to lifethreatening infections at the 20th week of the pregnancy. It was at this point that expansion of the uterus pulled the IUD's tail string into the ordinarily sterile womb.

The Dalkon Shield's tail string was unusual among IUDs in being a multifilament string in which bacteria, ordinarily present in the vagina, could lodge between the filaments and wick upward into the womb. Internal memos indicate that A. H. Robins's management knew about the potential for this problem before the device went to market but were more concerned about how the stiff string might irritate men during intercourse. One manager at the Chap Stick factory, where tails were attached to Shields, pointed out the wicking problem and noted that the attachment process damaged the tails in ways that increased the likelihood of bacteria reaching the womb. He was fired.

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