The Dalkon Shield was an intrauterine device marketed as a safe and effective form of birth control. Soon after the device became available, however, women suffered infections and infertility, and some died. A. H. Robins Company continued to market and sell the device until 1974 but eventually went bankrupt under the weight of lawsuits.
By the early 1970’s, intrauterine devices, or IUDs, had been used safely and effectively as a form of birth control for decades. An aggressive marketing campaign by the distributor of one such IUD, the Dalkon Shield, placed profit over safety. Close to three million women in the United States were using the Dalkon Shield at the height of sales. The shield, sold by the A. H. Robins Company, was developed by Hugh J. Davis, a gynecologist, and Irwin Lerner, an engineer. The shield was three-quarters of an inch in size, had prongs on either side to prevent expulsion, and had a tail to aid in its removal. Unlike other IUDs, the Dalkon Shield’s tail was made with multifilament fiber encased in a nylon sheath, which became a vehicle for bacteria. Other IUDs used monofilament fiber. The Dalkon Shield’s design elements caused a majority of the health issues that arose.
Two women protest outside the courtroom in Richmond, Virginia, where A. H. Robins Company was ordered to set up a $2.48 billion trust fund for women harmed by the Dalkon Shield.
A Centers for Disease Control report in 1983 showed that pelvic infection was five to ten times more likely in women who used the Dalkon Shield over other IUDs. The success of the deceptive marketing campaign, combined with the poor design features of the shield, led to the eventual injuries, illnesses, and deaths. There were also many cases of sterility caused by the shield.
A physician associated with Johns Hopkins University, Davis had tested the new shield on 640 patients. Traditionally, no less than 1,000 subjects are used for clinical trials to be considered statistically valid. In Davis’s test, controls were poorly implemented, which skewed the results favorably to establish the marketability of the shield. Also, many of the test subjects used other forms of birth control during the study, and not all used the shield for the entire length of the study. In the end, Davis concluded that the birthrate for those using the shield was 1.1 percent, which was less than the birthrate for those taking the birth control pill. Davis had received revised results after publishing his report, which put the birthrate at more than 5 percent, but he failed to amend his study.
Because they are considered devices and not drugs, IUDs do not fall under the purview of the U.S. Food and Drug Administration (FDA). Davis and Lerner founded the Dalkon Corporation in 1970 and started to sell the shield on their own. Davis, by then a recognized expert in contraception, spoke before a U.S. Senate subcommittee about the dangers of the birth control pill and the need for safer alternatives. He failed to note that not only was he marketing just such an alternative but also owned the company that would produce the devices. Sales did not reach hoped-for levels, however, so the Dalkon Corporation sought the backing of a larger company.
A. H. Robins Company was one of the four hundred largest companies in the United States and could distribute products worldwide. The company, run by E. Claiborne Robins, Sr., lacked experience with contraceptive devices and so based its purchase of Dalkon Corporation on Davis’s flawed study. Furthermore, Robins bought Dalkon despite learning that actual pregnancy rates were nearly five times Davis’s published result. Robins also had no data on the safety of extended use. Robins paid $750,000 for the right to distribute the shield.
Robins began an aggressive marketing campaign and used Davis’s original study to promote the shield. Robins ignored its own medical advisory board and marketed the shield, beginning in early 1971, to general practitioners instead of obstetricians and gynecologists exclusively. The company took the additional step of marketing beyond the medical field as well to further promote sales.
High-ranking officials at the company, as well as E. Claiborne Robins, received a warning from Lerner as early as 1970 about a potential “wicking effect” caused by the use of the multifilament tail. Because the tail was open at both ends, bacteria could easily travel between the filaments and past the protective cervical plug into the normally sterile uterus. This fact was confirmed by the company’s own quality control department. The department suggested heat sealing both ends, but the design change would have slowed production, so the alteration was never made. The sheath over the filaments also had a tendency to break down over time. The damaging effects of the wicking and the breakdown of the sheath were made worse by the decision to include in the sales literature information that the shield could be left in place for five years or more. The sales literature contradicted the recommendation made by the company’s own medical board, which warned that the device should be changed every two years. Because of Robins’s aggressive marketing, the shield outsold all other IUDs combined from 1971 to 1973.
Reports of high pregnancy rates and infections came in from field reports from medical consultants within the first month of release, but the company disregarded the reports. The first reports of septic abortions—abortions caused by infections in the uterus—came in soon after. The prongs also caused perforations of the uterus in pregnant women. The reports of the first two deaths occurred in May of 1973. Two women died within three days of detection. In response to the deaths, Robins merely printed new labels on the shield’s packaging that recommended removal of the shield during pregnancy. It was not until the company received notice of a forthcoming article in the American Journal of Obstetrics and Gynecology that it chose to send letters to 120,000 physicians, stressing the urgent need to remove the device from women who were pregnant. These letters came a full two years after the same recommendation was made by the company’s own consultants.
By 1973, the company was facing several hundred lawsuits. The first suit came to trial in December of 1973. Connie Deemer’s uterus had been perforated by the shield while she was pregnant, leading to lifesaving surgery. The prosecuting attorney in the case was the first to discover Davis’s financial stake in the shield. He also found the memo to company directors outlining the misleading birthrate statistics, which proved the company deliberately withheld the information, and that they most likely did so to increase sales. Because of the large number of lawsuits, cases were combined first at the state level in Minnesota and later on a national level at the federal court in Virginia under Judge Robert Merhige, Jr.
One of the most important issues discovered in trial was that Robins added copper and copper sulfate to the design. Had this been known by the FDA, the shield would have then been placed under the stricter federal guidelines and faced years of testing. Robins, however, never reported the addition of the copper sulfate to the FDA. It was at this time that the FDA requested that Robins withdraw the shield from the market, and by summer, 1974, Robins stopped further distribution of the shield. During trial, the wicking tests of the tail string that Robins performed also were confirmed, and it was determined that the company willfully destroyed incriminating documents. In December, 1987, Merhige ordered Robins to create a trust fund of $2.48 billion for women affected by the Dalkon Shield.
The stigma surrounding the harmful health effects of the Dalkon Shield caused a downturn in the entire IUD market, with sales of IUDs dropping off by two-thirds over the ten years following its initial release to the market. The large numbers of national lawsuits led to the establishment of a $2.6 billion trust fund to cover damages and to try to restore the fertility of women affected by the shield. More than 200,000 women received financial compensation from the trust. The scandal and litigation was large enough that by 1985 it bankrupted one of the largest companies in the United States.
Furthermore, in 1976, the FDA first began to require the testing and approval of all medical devices, and not just drugs, in part because of the Dalkon Shield case. Medical device amendments were added to the Food, Drug, and Cosmetic Act of
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citation-type="booksimple" xlink:type="simple">Breslin, Catherine. “Day of Reckoning.” Ms., June, 1989. A personal account of harm caused by the Dalkon Shield. Examines the impact of the A. H. Robins bankruptcy proceedings on women who were harmed by the device. Also discusses the efforts of various organizations formed to protect the rights of women who claimed harm. -
citation-type="booksimple" xlink:type="simple">Hawkins, Mary F. Unshielded: The Human Cost of the Dalkon Shield. Toronto, Ont.: University of Toronto Press, 1997. Focuses on the history of the Dalkon Shield, from its development to the years of litigation. Contains little discussion, however, of the “human cost” of the shield and its effect on the women who used the device. -
citation-type="booksimple" xlink:type="simple">Kimble-Haas, Sheila L. “The Intrauterine Device: Dispelling the Myths.” Nurse Practitioner 23, no. 11 (1998). An exploration of the positive aspects of IUDs on the market and how the Dalkon Shield case damaged the reputation of IUDs in general. -
citation-type="booksimple" xlink:type="simple">Mintz, Morton. At Any Cost: Corporate Greed, Women, and the Dalkon Shield. New York: Pantheon Books, 1985. A comprehensive account of the acquisition and marketing of the Dalkon Shield by Robins and of the lawsuits. Contends that A. H. Robins officials were aware of the potential danger of the device from the beginning but were driven by the profit motive. -
citation-type="booksimple" xlink:type="simple">Perry, Susan, and Jim Dawson. Nightmare: Women and the Dalkon Shield. New York: Macmillan, 1985. Traces the saga of the Dalkon Shield through early 1985, using material gleaned from examination of thousands of documents. Focuses in particular on the lawsuits that arose in Minnesota. -
citation-type="booksimple" xlink:type="simple">Sobol, Richard B. Bending the Law: The Story of the Dalkon Shield Bankruptcy. New York: Notable Trials Library, 1996. A study of the litigation process, from the beginning lawsuits to the establishment of the trust fund. Also explores the bankruptcy of A. H. Robins.
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