A. H. Robins Must Compensate Women Injured by the Dalkon Shield

Date December 11, 1987

A federal judge’s ruling in a bankruptcy case required the A. H. Robins Company to compensate 200,000 women who had been harmed by the Dalkon Shield contraceptive intrauterine device.

Locale Richmond, Virginia

Key Figures

• Robert Merhige, Jr. (1919-2005), U.S. district court judge from Virginia
• Miles Lord (b. 1919), U.S. district court judge from Minnesota
• E. Claiborne Robins, Jr. (b. 1943), president of A. H. Robins
• E. Claiborne Robins, Sr. (1910-1995), retired president and chief executive officer of A. H. Robins
• Hugh Davis (b. 1927), coinventor of the Dalkon Shield
• Roger Tuttle (b. 1930), attorney for A. H. Robins

Summary of Event

In the 1970’s, the prestigious pharmaceutical firm A. H. Robins Company distributed a contraceptive intrauterine device (IUD) called the Dalkon Shield. Promotional materials described it as a superior IUD with a high birth control effectiveness rate. Amid controversy over the safety of birth control pills, the Dalkon Shield was marketed as a safe alternative form of contraception, appropriate even for women who had never given birth. In the period 1971-1974, more than 2.5 million Dalkon Shields were implanted in women in the United States, and more than 1 million of the IUDs were shipped abroad.

A. H. Robins, the maker of numerous products, from cough syrups to flea and tick collars for pets, purchased the rights to the Dalkon Shield in 1970. In 1971, the company began distributing the shield, a molded plastic, crab-shaped device with “fins” on each side. Like other IUDs, the device was intended to be inserted into a woman’s uterus to prevent pregnancy. A multifilament string was attached to the bottom of the shield to aid in removal and to provide a check on expulsion.

A. H. Robins purchased the rights to the Dalkon Shield because the company recognized the demand for a safe, reliable form of birth control. Congressional hearings in 1970 exposed the health risks associated with birth control pills, and the resulting controversy increased the demand for nonhormonal contraceptive methods, such as IUDs. The Dalkon Shield was portrayed by one of its inventors (and later by the Robins firm) as a “superior modern contraceptive” with outstanding effectiveness and safety, and thus seemed to fit the bill.

A study published in 1970 by Hugh Davis, coinventor of the Dalkon Shield and at the time a physician affiliated with The Johns Hopkins University, reported that tests conducted on women who had used the Dalkon Shield yielded a low 1.1 percent pregnancy rate and a low expulsion rate. Later analyses of Davis’s data found that his study underestimated both pregnancy and expulsion rates of the Dalkon Shield, but promotional materials circulated by the Robins firm continued to use the lower pregnancy rates cited in the original study. Further enhancing the attractiveness of the Dalkon Shield for potential users was the claim that the smaller version of the device was safe for young women who had not yet had children. IUDs had previously been viewed as appropriate primarily for women who had already had children, because their bodies were generally better able to tolerate the devices.

Almost from the beginning, physicians reported to Robins that the Dalkon Shield seemed to have a higher pregnancy rate than was claimed, that the device was difficult to insert and remove, and that it might be a cause of infections in women wearing it. Many women fitted with the device complained of excruciating pain upon insertion and painful cramping thereafter.

As early as 1972, Robins officials were told that the Dalkon Shield might be linked to spontaneous septic abortions (miscarriages with associated infections), which are rare in industrialized countries. In March, 1973, an Arizona woman who had been wearing a Dalkon Shield when she became pregnant died from a septic abortion. A. H. Robins never specifically acknowledged that the Dalkon Shield’s design may have contributed to sepsis in women who became pregnant while wearing it, but the company did notify doctors in October, 1973, that “serious consideration should be given to removing the device” once a woman becomes pregnant.

In February, 1975, the first legal case involving the Dalkon Shield was decided in favor of the plaintiff, Connie Deemer. By that time, the product had been removed from the market but remained in the wombs of hundreds of thousands of women. In lawsuits across the United States, women claimed that the Dalkon Shield caused a variety of health problems, including infertility (difficulty in conceiving), sterility (inability to conceive), pelvic inflammatory disease (infections of the uterus, ovaries, or Fallopian tubes), and perforations of the uterus. Some women were forced to undergo hysterectomies as a result of complications they asserted were caused by the Dalkon Shield. Others miscarried fetuses or bore deformed infants who were conceived with the Dalkon Shield in place.

In many of the lawsuits, women’s health problems were attributed to defects in the design of the Dalkon Shield itself. In particular, some evidence implicated the Dalkon Shield’s multifilament string as a cause of pelvic inflammatory disease infections, which can result in sterility or infertility. As early as 1970, A. H. Robins officials were warned by an employee that the string might have a “wicking” effect, causing it to transport bacteria from the vagina into the uterus, resulting in infection. Some later studies confirmed this wicking effect.

Because of the large number of women who had Dalkon Shields inserted in them, attorneys recognized the potential for a large number of lawsuits. Some attorneys even specialized in Dalkon Shield cases, taking on large numbers of clients who claimed that the IUD had harmed them. In Minnesota, where a large number of Dalkon Shield cases were filed, several such cases were assigned in 1983 to U.S. District Judge Miles Lord, who was considered to be a maverick with populist instincts. Judge Lord’s involvement in these cases was significant for two reasons. First, Lord issued a document production order that permitted attorneys for the women to obtain documents from A. H. Robins. These documents would later prove useful in other cases brought by women against the company. Second, Lord attracted nationwide publicity to the controversy over the Dalkon Shield when, on February 29, 1984, he lectured three Robins officers in open court. In his remarks, Lord charged the officials with corporate irresponsibility and beseeched them to track down women wearing Dalkon Shields so that the women could be urged to remove the devices. Later that year, a federal judicial disciplinary panel ordered Lord to expunge from the court record his reprimand of Robins employees.

In October, 1984, A. H. Robins announced a $5 million program to pay for the removal of Dalkon Shields from women still wearing them. In advertisements, Robins informed women that it would pay medical bills for removal of the Dalkon Shield. One television commercial stated, “There is substantial medical opinion that continued use of the Dalkon Shield may pose a serious personal health hazard and it should be removed.” The removal program occurred amid substantial adverse publicity, including testimony by a former attorney for A. H. Robins, Roger Tuttle, who revealed in the summer of 1984 that he and other Robins employees had destroyed documents relating to the Dalkon Shield. In addition, by the end of 1984, about twelve thousand women had brought claims or lawsuits relating to the device. About one-third of these cases were unresolved at that time.

On August 21, 1985, as claims against A. H. Robins continued to mount, the company filed for Chapter 11 bankruptcy protection against creditors who, Robins feared, could plunge the company into financial ruin. By 1985, Robins and its insurer, Aetna Casualty and Surety, had settled ninety-five hundred injury suits at a cost of $530 million. New lawsuits were reportedly arriving at a rate of four hundred per month.

The bankruptcy case was assigned to Judge Robert Merhige, Jr., at the U.S. District Court for the District of Virginia. Judge Merhige had handled hundreds of Dalkon cases prior to taking on the bankruptcy case. He was reputed to be a liberal judge and had rendered controversial decisions on such matters as school busing, women’s rights, and the environment. On December 11, 1987, Judge Merhige ordered Robins to set up a trust fund of $2.48 billion from which would be settled the claims of nearly 200,000 women said to have been harmed by the Dalkon Shield.

Significance

The bankruptcy reorganization of A. H. Robins had the effect of organizing individual claims by women across the United States into a single class-action format. Another well-known example of mass tort litigation that was settled through bankruptcy proceedings involved several manufacturers of asbestos, including the Manville Corporation, which also filed for bankruptcy as a result of product liability claims. As part of his supervision of the A. H. Robins bankruptcy reorganization, Judge Merhige was given considerable authority to resolve the Dalkon Shield cases, which constituted most of the creditor claims against the company.

In 1987, Merhige ordered Robins to institute a national advertising campaign to notify women of the class-action proceedings. More than 330,000 potential claimants responded. That number was then narrowed by the court to 196,000 claimants. While it was involved in the bankruptcy proceedings, A. H. Robins continued to reap a profit through the popularity of certain other products that it manufactured. The company’s generally favorable financial picture prompted a bidding war by other pharmaceutical firms, eventually resulting in a takeover in 1988 by American Home Products (which later changed its name to Wyeth). Members of the Robins family, who owned 42 percent of the company’s stock, received nearly $300 million as a result of the deal with American Home Products. E. Claiborne Robins, Jr., and E. Claiborne Robins, Sr., agreed to donate $10 million of that amount to the Dalkon Shield victims’ trust fund.

Upon acceptance of the buyout plan by American Home Products, Judge Merhige set up a Dalkon Shield claimants trust to administer the plan. Under the plan, women would be able to claim compensatory, but not punitive, damages. In 1988, 95 percent of the women claimants who voted approved the plan. Several options were made available to claimants. Women with relatively minor claims could accept payment of $725, whereas women with more serious injuries would be able to settle for predetermined settlement amounts corresponding to severity of injury and to amounts paid for similar injuries in prebankruptcy settlements. Women in a third category would be able to negotiate their cases on an individual basis.

Attorneys for some of the claimants filed an appeal, claiming that the $2.5 billion trust fund was too small. Some women also contested court decisions that barred future individual lawsuits against senior Robins officials and Aetna Casualty and Surety. Their appeals were ultimately rejected in 1989.

Among the beneficiaries of the Dalkon Shield debacle were attorneys who represented women claimants. Many attorneys represented large numbers of these clients on a contingency fee basis whereby they received between 16 and 52 percent of any settlement. Standard contingency fees are between 20 and 33 percent.

A bankruptcy declaration such as the one made by A. H. Robins benefits a company facing large numbers of product liability claims by allowing it to concentrate on the immediate problem of settling those claims. Class-action litigation such as that in the Dalkon Shield case has the advantage of preserving the time and resources of claimants who might otherwise need to bring individual lawsuits. The notification procedures implemented by the court made potential claimants aware of their rights to seek settlements for damages suffered. As many women who wore the Dalkon Shield contraceptive device and suffered from its various effects pointed out, however, the monetary compensation awarded could not restore either their health or the lives of their unborn children.

Bibliography

Breslin, Catherine. “Day of Reckoning.” Ms., June, 1989, 46-52. Provides a personal account of harm caused by the Dalkon Shield and examines the impact of the A. H. Robins bankruptcy proceedings on women harmed by the device. Also offers insight into the efforts of various organizations formed to protect the rights of women who claimed that they were harmed by the Dalkon Shield.

Hargitai, Dianne, and Paula Span. “My IUD Nightmare.” Glamour, October, 1985, 258-259, 329-334. Presents a personal account of medical problems that the author asserts were brought on by pelvic inflammatory disease associated with her use of the Dalkon Shield. Also presents a history of the Dalkon Shield, from its initial distribution by A. H. Robins to the removal program following the filing of thousands of lawsuits by women who had used the device.

Hawkins, Mary F. Unshielded: The Human Cost of the Dalkon Shield. Toronto: University of Toronto Press, 1997. Focuses on the costs—physical, emotional, and financial—to the individual women harmed by their use of the Dalkon Shield. Also analyzes the roles of the mass media and the American medical and legal systems in the unfolding of the class-action suit against A. H. Robins.

Mintz, Morton. At Any Cost: Corporate Greed, Women, and the Dalkon Shield. New York: Pantheon Books, 1985. A business reporter for The Washington Post provides a comprehensive account of the acquisition and marketing of the Dalkon Shield by A. H. Robins and of the lawsuits brought by women who claimed they had been harmed by the device. 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. Calls for stricter legislation and for criminal prosecution of corporate officials who endanger lives.

Perry, Susan, and Jim Dawson. Nightmare: Women and the Dalkon Shield. New York: Macmillan, 1985. Comprehensive work 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. Asserts that A. H. Robins officials were aware of problems with the device from the outset but promoted it anyway.

Sobol, Richard B. Bending the Law: The Story of the Dalkon Shield Bankruptcy. Chicago: University of Chicago Press, 1991. Describes in detail the A. H. Robins bankruptcy filing and criticizes Judge Merhige’s handling of the case.