this page says some things were with held from the reports, when things are all over the truth comes out. if you look at the dalkon shield it will just make you sick to try and figure how they got it in there and out of there.

Roberta Bloss
Joseph Corneli
Chris Moon
Lucas Tomsich

The Dalkon Shield
History of Science 3333 H
December 8, 1997


Introduction

In this paper, we will present a history of the Dalkon Shield, one of a number of different contraceptive devices that were inserted into the uteruses of many women worldwide, during the last half of this century. We will contextualize the Dalkon Shield within a broader discussion of contraceptive devices; present a narrative of its development by Dr. Hugh Davis, Mr. Win Lerner, and the A. H. Robins Company; and describing the circumstances that led to the bankruptcy of A. H. Robins. We will then discuss a variety of perspectives that critics and observers took on these developments and events. Finally, we will discuss the harm that users of the Dalkon Shield were often subject to, outcomes that this has had on society, and point out some themes from the case of the Dalkon Shield that continue to be relevant today.

History of the Dalkon Shield

Late nineteenth century America was marked by a rising professional class. Many roles that had been filled by craftsmen or women trained in traditional methods for providing goods and services were increasingly filled by members of these new experts. In particular, women came to rely, not on traditional methods for contraception, but on the new technologies and methods made available by the medical profession (Grant, 9-10).

Doctors sought to solidify their control over the dissemination of contraceptives, and petitioned the federal government to regulate the sale of contraceptives. One result of this action was the Comstock Law, in effect from of 1873 until 1938, that prohibited the shipment of contraceptives across state borders (Perry and Dawson, 9).

The concept of using contraceptives for population control purposes steadily gained in popularity early in this century. Eugenicists saw them as an important technology in their fight against "race suicide". In 1942, four years after the Comstock Law was repealed, the Planned Parenthood Federation of America was founded. The Federation's goal was to promote public health, as it related to such social objectives as human resource management (Grant, 13).

The first modern Intrauterine Device (IUD) appeared in 1909 in Poland, but their use dates back to antiquity (Perry and Dawson, 9). When the IUD was developed in America in the middle of this century, many saw it as the ultimate contraceptive. This was primarily because use required little ongoing effort; once inserted, it was assumed, it could be forgotten by the user.

The first International Conference on Intrauterine Contraception in 1962 promoted the IUD. The conference was sponsored by the Population Council, a group concerned with curbing worldwide population growth. In his opening statement for the conference, Dr. J. Robert Willson said "We have to stop functioning like doctors, thinking about the one patient with pelvic inflammatory disease [...] how serious is that for that particular patient and for the population of the world in general? Not very [...] perhaps the individual patient is expendable in the general scheme of things" (Perry and Dawson, 23).

The first indications that then-popular oral contraceptives had negative side effects were discovered in 1962, just weeks before this conference (Perry and Dawson, 25). In the late 1960s, growing concern about the Pill inspired two FDA hearings on oral contraceptives and a congressional hearing on contraceptives in 1970. Proponents on both sides of the safety issue said that their claims had been substantiated through scientific studies. An important witness, Dr. Hugh J. Davis, the director of the Family Planning clinic at Johns Hopkins University, said that poor women needed a method that required less motivation than the Pill, and that middle class women (who made up the largest group of Pill users) needed a safer method (Grant, 31).

An inventor as well as a gynecologist, Davis began to test his experimental IUD, the Incon Ring, at Johns Hopkins in the 1960s. The studies revealed high expulsion rates, and similar ring IUDs had been found to be notorious for perforation of the uterus and subsequent bowel strangulation (Mintz, pp. 25-27).

Davis was also a partner in a firm called Lerner Laboratories, with an electrical engineer Lerner who had the ability to begin to market Davis' designs. Lerner "invented" the Dalkon Shield by adding the Dalkon Shield by adding lateral spikes, a central membrane, and a multifilament "tail" to an Incon Ring frame. These adaptations were intended to decrease the expulsion rate of the apparatus, increase its surface area (which Lerner and Davis believed an important factor in the effectiveness of an IUD), and make it easier for doctors to check its position in the uterus. The patent for this device was held in Lerner's name; financial interest did not have to go to the University as it did with the Incon Ring (Grant, 37). Davis began testing the Dalkon Shield at Johns Hopkins in 1968. The study was performed with 640 women subjects and, on average, these women participated in the study for 5.5 months. There was a 60 percent discontinuation rate, and these data were not included in Davis' final assessment. Davis instructed participants to use sperimcidal foam for added protection against pregnancy; however, this was not disclosed in his published documents (Perry and Dawson, 33).

The partners in Lerner Laboratories formed the Dalkon Corporation to market their product. In the 1970 Senate hearings, and in an article in the Obstetrics and Gynecology Journal, Davis said that "local alternatives" such as IUDs were preferable to contraceptives with systemic effects (i.e. the Pill). In this article, Davis especially promoted the shield intrauterine device, calling it a "superior modern contraceptive" (Grant, 44).

In June 1970, A. H. Robins, a large and well-respected drug company, purchased the Dalkon Shield from the Dalkon Corporation. Davis and Lerner accepted positions as consultants to the company. Two vice presidents of the A. H. Robins company suggested delaying the purchase, pointing to Davis' incomplete (copper had just been introduced to the Shield) and inaccurate studies (results in pregnancy rates represented by Davis were much lower than follow-up studies on the same subjects). They were ignored. A "five year, ten investigator" study was begun in December 1970 (Davis was one of the investigators), but A. H. Robins chose to put the Dalkon Shield on the market in January 1971 (Perry and Dawson, 244).

At this time, there were over 70 IUDs on the market. Davis wrote a book and several articles promoting his device over the others. IUDs were increasingly popular among physicians, because they were not associated with the demonstrated adverse effects of the Pill and had a high "use-effectiveness" ratio (Grant, pp. 44-46). That is, unlike condoms or oral contraceptives such as the Pill, which might have higher effectiveness in clinical studies than outside the clinic where people might chose not to use them, IUD wearers did not have to chose whether to use them at the time of coitusand thus the IUD's contraceptive effect was automatic. As a contraceptive that required little motivation to use after the initial insertion, IUDs were seen by those concerned about population as an ideal product for the Third World. Garrett Hardin, a population control advocate and key proponent of the modern theory of "the tragedy of the commons", had a viewpoint that was somewhat reminiscent of Willson's statement, above. Hardin said that "even if IUDs fail for 10% of women, [they are] a blessing to [any] country as a whole" (Grant, 72).

However, a growing amount of criticism was being leveled against the Dalkon Shield and IUDs in general. Examples include: Dr. Mary Gabrielson's address to the American Association of Planned Parenthood Physicians in Detroit, presenting two studies of patients in two California Planned Parenthood clinics, where she had found four to five times the pregnancy rate published by Davis and Thad Earl, an early partner in the Dalkon Shield Corporation wrote to A. H. Robins, saying that he was going to stop using the device. It is important to point out that while some observers believed that the Dalkon Shield was much more dangerous than other IUDs, the medical literature reported problems with all IUDs, including "chronic and acute infection, perforations, infertility, complicated pregnancies, injuries and death" (Grant, 69).

Dalkon Shield sales began to decline in mid-1972. At this point, rather than heeding critics, A. H. Robins began a huge domestic advertising campaign and mass exportation (at greatly discounted prices) through the US Agency for International Development. About two million Shields were shipped to 79 other countries by this agency, unsterilized, and with one inserter per 10 shields and one instruction book (in English) per 1000 (Hicks, 39).

In May 1973, the Majzlin Spring was pulled from the market by the FDA, furthering the reaction against IUDs. The popular media began to raise questions about the under-reporting of problem cases, and inaccurate claims of manufacturers. However, sometimes in the same publication, medical authorities reassured readers (Grant, 54).

In June 1974, A. H. Robins stopped selling the Shield in the US "until safety questions were resolved". In January 1975, Dr. Howard J. Tatum published a study that showed that the Dalkon Shield device was the only IUD on the market with a wicking string. A. H. Robins responded by announcing the use of new monofilament strings, and the collection of unused shields. The same month that Tatum's study was released, the FDA issued a statement the Dalkon Shield was no more risky than other IUDs.

A 1976 microscope study found that the shield had a rough surface that was irritating and could harbor bacteria; however, the association between irritation, infection and effectiveness in all IUDs led the researchers to question whether an "honestly manufactured IUD, which should be absolutely safe, be efficient?" (Grant, 65).

In 1976, A. H. Robins announced that they were going to stop manufacturing the Shield. Approximately 600 lawsuits were pending against the company at that time. In 1980, A. H. Robins sent a letter to physicians recommending the removal of Shields from women who still wore them. In 1984, they released "new" information stating that risk increased with the length of use, and said that they would pay for removals.

After filing for bankruptcy in 1985, a reorganization agreement provided for the sale of the A. H. Robins Company to American Home Products. The court decided that American Home Products was to provide a $2 billion trust fund for subsequent claims of personal injury. The trust fund was set up to last 20 years, from 1989, when it was officially established. Also as part of the settlement, the Robins family, the corporation, and all third parties (such as doctors and A. H. Robins' insurance company) were granted immunity from future lawsuits. A deadline for filing claims was set in 1986; 306,931 were filed by the deadlineabout 8% of the estimated four million users (Hicks, 7).

Central Ethical Issues

Here we present some of the view points held by contemporary experts, commentators, and women who had the IUD. Some of the issues mentioned here were part of widespread popular debate; some, such as Davis' financial interest in the Shield only came to light in court after 1974.

There is ample evidence that A. H. Robins Company advertised, developed, tested, exported, and continued to market a product that was known to be dangerous and ineffective. Other instances of professional conduct that seem distinctly unethical include these: A. H. Robins Company continued to use data from Davis' original studies in books and advertisements long after new data that put the Dalkon Shield in a more unfavorable light were available; while Davis received stock and a percentage of the profits of the A. H. Robins Company, his financial interests in the Dalkon Shield were never mentioned in their promotional information nor his numerous articles, books, and studies that supported the Dalkon Shield. The problems generated by the bias of researchers evaluating a product, from whose sales they would benefit were starkly apparent in Davis' work. During cross-examination in a court hearing, Davis admitted that there was a conflict of interest. He said "I did not feel I should be in a position of testing and evaluating a device in which on one side I was functioning as an evaluator and on the other side I was in a capacity to, as a private individual, profit from participating in the corporation" (Mintz, 176).

As we mentioned above, all IUDs intrinsically had some risks associated with themthe risk of infection and hysterectomy was always present for users. The Dalkon Shield, while it had some distinct problems with its design and handling, was not exceptional in this regard. Researchers questioned whether any IUD could be at the same time both safe and effective. The Dalkon Shield was nonetheless marketed as a both a safe and effective contraceptive.

During the period that the Dalkon Shield was on the market in the USA and abroad, there was widespread concern about the apparent epidemic of population growth. Many felt that limiting of the procreative abilities of any given individual was justified by the dangers that an exponentially growing population posed to everyone. With this assumption, many of the proponents of population control felt that it was justifiable for women in Third World countries to undergo greater risk and suffering related to contraception than women in America (the risk from contraceptives would be proportional to the perceived risk from increased population [Grant, pp. 72-74] ). Others felt less sure that this increased suffering was justifiable.

Many women thought that they were being "liberated" by IUDshowever, during the last two centuries a significant proportion of control over procreation was being shifted from women to their health care providers. In addition, as control over procreation was removed from the sex act (for instance, through implantation of an IUD) a woman lost some of her autonomy in regard to procreative decisions (Grant, 138).

One part of the problem, some thought, was that FDA regulation of IUDs was inadequate. Medical devices were not regulated as harshly as drugs. This was primarily because they were regulated by a 1930 amendment to the Food and Drug Act that was designed to control the sale of illegitimate products invented by quack doctors; this amendment made it possible for the FDA to take care of simple problems, but not to keep up with rapid technological change. In 1976, a new Medical Devices amendment to the Act required that companies demonstrate the safety of IUDs before they could be put on the market (Mintz, pp. 114-115).

If we were to reduce the Dalkon Shield case to one single ethical issue, it might be summarized in this way: the A. H. Robins Company knowingly harmed people in order to earn money. Neither physicians, nor the government, took timely and suitable action to stop this.

Historical outcomes

Eight percent of the women who used the Dalkon Shield filed claims; it is not known how many more were harmed by the device. Of the 190,000 total claims, 137,000 have been settled. Of these settlements, more than 115,000 were for $1,000 or less; very inadequate compensation, according to Hicks (see p. 7). In court, women were asked very personal questions relating to their past sexual behavior and personal hygiene habits. As a direct result, many women opted against filing claims because they did not want to be publicly humiliated (Mintz, pp. 194-195).

The Dalkon Shield made a lasting impressionit is now widely symbolic of the risks of birth control. It is also used as an example to illustrate the "improvements" in modern IUDs (a general search of the Internet for "dalkon shield" will bring up many documents about how modern women resist using IUDs because of the unfavorable impression that the Shield left in the public's mind. These documents put forth the questionable claim that modern IUDs function in a very different way from the Shield). The amendment passed the year the Dalkon Shield was pulled from the market means that these devices will be subject to stricter review and regulation than their predecessors.

The Dalkon Shield case did not result in lasting change in the way people understand sex. For instance, the cultural importance assigned to penile-vaginal intercourse and the perception that women are solely responsible for birth control (factors that Grant argues aree important in creating a foothold for problems like those associated with the Dalkon Shield) have persisted (see, pp. 121, 138-139). There has not been lasting change in the technologies that we use to deal with these valuesIUDs dropped from the American market for a time, but new types of insertable or implantable birth control technologies are being introduced, and IUDs are in fact making a comeback in the United States (Grant, 150). Many of the ethical issues enumerated here continue to apply to these "new" devices.

Conclusion

We found four central themes in the literature on the Dalkon Shield that illustrate ethical issues: (1) population control, (2) the biological functioning of IUDs generally, (3) corporate bias, and (4) conflict of interest. These issues are of ongoing concern, and we summarize them here. First, with a growing population, especially in the "developing world", we face an ethical dilemma regarding the apparent conflict between individual health and preferences and the collective well -being of humanity. Second, with the continued widespread use of IUDs internationally, and their relatively recent reintroduction to the US market, we are faced with the inherent contradiction in their function; they are best understood as being effective in preventing pregnancy by irritation of the uterus and such irritation inevitably increases the risk of infection. Risk of infection is also increased by each insertion of the devices, and increases proportionally to the length of time they are wornthe Dalkon Shield was not exceptional in these regards. Third, unethical behavior such as that of the A. H. Robins Company is, unfortunately, not exceptional to the corporate world. It is painfully clear that much of the physical and emotional harm perpetrated on the women who used the Dalkon Shield could have been avoided if A. H. Robins Company had not ignored or denied data showing that the Dalkon Shield was unsafe. Finally, the problems with conflict of interest facing modern researchers and engineers are very similar to those illustrated by Dr. Hugh Davis, whose financial concerns as an inventor, consultant and stockholder came to dominate his ethical concerns as a scientist.

Bibliography

Grant, Nicole J. The selling of contraception : the Dalkon Shield case, sexuality, and women's autonomy. Columbus: Ohio State University Press, 1992.

Hicks, Karen M. Surviving the Dalkon shield IUD : women v. the pharmaceutical industry. New York: Teachers College Press, 1994.

Mintz, Morton. At any cost : corporate greed, women and the Dalkon Shield. New York: Pantheon Books, 1985.

Perry, Susan and Jim Dawson. Nightmare: Women and the Dalkon Shield. New York: Macmillan Publishing Company 1985.


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