DESIGNING THE POPULARITY OF THE DALKON SHIELD
by
KATHRYN GOLDBERG
Submitted in partial fulfillment of the requirements
for the degree of Master of Arts
Thesis advisor: Dr. Jonathan Sadowsky
Department of History
CASE WESTERN RESERVE UNIVERSITY
May, 2012 CASE WESTERN RESERVE UNIVERSITY
SCHOOL OF GRADUATE STUDIES
We hereby approve the thesis/dissertation of
Kathryn Goldberg ______
M.A. History candidate for the ______degree *.
Dr. Jonathan Sadowsky (signed)______(chair of the committee)
Dr. Alan Rocke ______
Dr. James Edmonson ______
______
______
______
4/2/12 (date) ______
*We also certify that written approval has been obtained for any proprietary material contained therein.
ii
Copyright © 2012 by Kathryn Goldberg All rights reserved
iii
For my mother, For my father, who taught me the who taught me the value of empathy. joy of curiosity.
iv
Table of Contents
List of Figures …………...... 2
Acknowledgements ...... 3
Abstract ...... 5
Text ...... 6
I. Introduction ...... 7
II. Historiography ...... 14
III. Development ...... 20
IV. Re-Marketing and the End ...... 62
V. Conclusion ...... 68
Appendix...... 71
Research Locations ...... 72
Works Cited ...... 73
1 List of Figures
Figure 1 Dr. Hugh J. Davis ...... 11
Figure 2 Dalkon Shield Distribution Data...... 12
Figure 3 A Dalkon Shield...... 27
Figure 4 The Flying Uterus Advertisement...... 45
Figure 5 They Like the Boss...... 56
Figure 6 “How Much They Made”...... 65
2 Acknowledgements
This paper could not have been completed without the considerable support
of many individuals and organizations. Dr. Jonathan Sadowsky sparked my interest
in the history of medicine in the Fall of 2008. The discussion-based style of the class made me want to be a historian from the first day. The Dittrick Museum of Medical
History and its employees, especially Dr. James Edmonson and Ms. Jennifer Nieves, encouraged this interest and were always generous when imparting knowledge of contraceptive history. Dr. Alan Rocke has continuously offered his thoughtful advice and read several drafts of this thesis, having been kind enough to step in as an acting thesis advisor. Dr. Kenneth Ledford offered considerable knowledge of how to construct a Dalkon Shield historiography.
I would like to thank the SAGES program for their generous financial support, without which I could not have gone to Washington D.C. and Charlottesville, VA in order to conduct the requisite primary research for this project. The SOURCE office at Case Western Reserve University graciously arranged for the funding from SAGES to be administered. In Washington, Dr. Stephen Garber offered considerable advice on how to manage government archives and documents.
There are few words to describe my gratitude to the individuals at the
University of Virginia Law Library. The friendship and unwavering support from
Special Collections Archivist, Ms. Cecilia Brown, meant the world to me. She helped
me with everything from finding a place to live, to navigating the enormous breadth
3 of documentation in the Dalkon Shield Claimants Trust Collection. In every archive
and library I encountered, I found friendly faces and welcome advice.
This work would not have been possible without the support of my friends
and family. Many of these wonderful individuals have read through several drafts of my thesis, or patiently sat through one of my excitable rants on an obsolete medical device. Any mistakes in this document are solely of my own doing and appear despite the excellent advice and guidance of the people mentioned in this section.
4 Designing the Popularity of the Dalkon Shield
Abstract
by
KATHRYN GOLDBERG
The 1960s were a time of rapid change in the field of contraception. A few ambitious physicians saw an opening in the birth control market for a highly effective contraceptive that would not contain synthetic hormones. The Dalkon Shield, an IUD, developed by Dr. Hugh Davis, was one such contraceptive. However, the device that
Davis promoted and the A.H. Robins Company sold was neither as effective nor safe as claimed. There were numerous instances of corporate misconduct on the part of
Robins. Many have decried the device as a deadly tool of corporate henchmen. The truth is more complicated than such a simple morality tale. Loopholes in federal legislation permitted a faulty device to be released in the consumer market, and cultural deference for physicians came before the complaints of female users. This combination of male-dominated social structures, and a lack of governmental consumer protection, permitted this modern medical disaster.
5 Highlight our ‘success-story’ (we certainly have one to tell) to the non-believers and
non-users, dwelling on the fantastic acceptance of the Dalkon Shield…
George J. Mancini1
A ‘Non-believer’
Mary Bolint had plenty to celebrate.2 She was engaged to a wonderful man,
Ned Ripple, and a junior at the University of Arizona with plans to continue onto law school. This proactive woman refused to blindly entrust her birth control choices to a physician. Mary carefully studied her contraceptive options and the available statistical information prior to making a birth control decision. The Dalkon Shield
seemed the clear winner among health conscious feminists in 1970. Her physician
agreed with the decision, and he inserted the device shortly before her wedding.
The first several months were plagued with heavy and intolerably painful
periods. Mary’s doctor patronizingly disregarded her concerns, and eventually the
uterine pain lessened. However, about a year after the insertion, Mary was
overcome by a wave of nausea while grocery shopping. That night she was rushed to
the hospital on suspicion of appendicitis. The surgeons were surprised to find a
healthy appendix, but large infectious abscesses covering her ovaries. The abscesses
1 George J. Mancini, ‘National Review: Sales and Marketing’, March-April 1972, Reel 20, Dalkon Shield Claimants Trust, University of Virginia Law Library, page 2. This quote has been included to demonstrate the dichotomy between Robins’ employee’s perception of the Dalkon Shield and the public uproar against the device. 2 Mark Dowie and Tracy Johnston, “A Case of Corporate Malpractice.” Mother Jones Magazine, November 1976, 36-50.
6 were drained and she was sent home. At this time, there were no public reports of infections caused by IUD use. The Dalkon Shield was left in place.
Over the next four months Mary would undergo four more surgeries, be legally dead for a brief time, and have the IUD and her reproductive organs removed.
Mary Bolint would never have children, and her health would be forever altered by the lack of essential hormones the ovaries normally release until menopause. She was one of the many women who brought suit against the A.H. Robins Company, but the money could not reverse the resultant infertility.
I. Introduction
The 1970s were a challenging time for many Americans. Their faith in trusted institutions was shaken as scandals splashed across the front pages of newspapers. The American public, reading about Watergate and watching the horrors of the Vietnam War play out on television, began to have serious doubts about the abilities of their government. The Thalidomide disaster and the racism of the Tuskegee experiments threw physicians into a new and sinister light. The public was losing confidence in prestigious men, men they had been taught to trust with their very lives. Physicians and government organizations were not infallible, as it turned out. The sad truth was that when they failed to do the basic requirements of their jobs, members of the public could be injured in deep and permanent ways.
Many American citizens were becoming disillusioned with male-dominated, poorly
7 run professional groups. The Dalkon Shield can be added to this list of governmental
and medical failures.
This thesis will contextualize the actions of the perpetrators and identify the
failures of the federal government to protect American consumers. Most of the previous writing on the Dalkon Shield has failed to explain why this event occurred.
This thesis will provide that explanation, and set the Dalkon Shield events in their appropriate social context. This is the first work of professional history to utilize the
Dalkon Shield Claimants Trust documents on such a large scale.3 Legal historians
and the victims of the device have written extensively about the Dalkon Shield.
While their writings are valuable in certain fields or as primary documents, the
works failed to take into account the social failures that a historical accounting of
the Dalkon Shield saga requires. This thesis will fill many of the holes that exist in
the historiography of contraception. Most public writings on the subject matter are
colored with rage, so the most unadulterated resources were the primary source
documents located in the University of Virginia Law Library. Corporate documents
uncovered during the discovery process, newspaper clippings, and medical articles
combine to tell the comprehensive story of a small, plastic intrauterine device that
forever changed the field of American birth control.
The Dalkon Shield was a medical device, specifically an intrauterine device
(IUD), used to prevent conception when inserted into the uterus. Prominent doctors,
businessmen, and government officials failed to protect women from this defective
medical device. Hailed as bastions of their communities by the public, it was their
3 These documents were donated to the University of Virginia Law Library in Charlottesville, VA.
8 duty and job to care for the health of consumers, their neighbors and their wives,
and it was a task they completely failed to complete. The story of Mary Bolint was
not unique, as Dalkon Shield infections were a relatively common complication of
the device. Their painful experiences with the Dalkon Shield IUD battered the trust
they felt for revered institutions: the physicians who should heal us, our government to protect us from the self-interested, and businesses that make up the fabric of the American success story. All failed to protect women from the suffering caused by the shield device.
The mechanism of IUDs was not well understood. Physicians knew one important fact, however. When present in the uterus, IUDs worked to prevent both
the fertilization of an egg and the implantation of an embryo. The means by which
they did this was unclear. Some IUDs consisted solely of inert plastic, while others
were made of both plastic and metal. During the insertion process, the device would
be pushed through the cervical opening and left in the uterus for an extended period
of time. This provided contraceptive protection to the user for as long as the device
stayed in the proper position.
The Dalkon Shield is historically significant because it forever changed the
face of birth control research and class action lawsuits, but this saga is even more
important for the insight it can provide into human nature. Individuals do not need
to be particularly cruel in order to commit cruel acts. The implicated physicians and
corporate executives were not singularly evil men. But great evil was done upon the
bodies of thousands of women, who were left infertile, or even died from diseases
contracted via Dalkon Shield use. A careful telling of this history can show the need
9 for government regulation and the necessity of accounting for women’s healthcare
needs. Government regulation can prevent incidences of medical misconduct such
as the Dalkon Shield saga.
The Dalkon Shield story is a convoluted tale. The complete telling would
involve a medical history, stories of personal pain, and an analysis of tort law. This
paper will only encompass the beginning of the saga. The Dalkon Shield was an IUD
women used for birth control. It was an inert medical device developed in 1968 by
Dr. Hugh J. Davis and Mr. Irwin Lerner. An image of Davis can be found below, in
Figure 1. The physical design of his Dalkon Shield, thought to be advantageous to retention, proved painful and dangerous when inserted into uteri. Some physicians repeatedly ignored the symptoms of their female patients during and after a Dalkon
Shield insertion. Additionally, the string on the Dalkon Shield acted as a conduit for bacteria, often leading to pelvic inflammatory disease. Without any government regulation in place to control human medical device testing, Davis was never forced to prove the safety and efficacy of the device. Nor was there any way for the government to monitor medical devices or enforce production standards at this time.
10
Figure 1, Image courtesy of Mother Jones Magazine
A.H. Robins Company, the pharmaceutical firm that purchased the Dalkon
Shield, used Davis’ misleadingly optimistic research results in an aggressive marketing campaign. Figure 2, below, illustrates Dalkon Shield sales between 1971 and 1973. The figure illustrates the device’s exponential rise to popularity in 1971, and its sudden decline from favor in 1972. The large numbers of sales were the result of an aggressive and dishonest advertising campaign run by Robins. Their executives are directly responsible for the questionable campaign that sent the
Dalkon Shield skyrocketing into popularity before device safety had been established.
11
Figure 2, Courtesy of the Dalkon Shield Claimants Trust
The owners of A.H. Robins were not an uncaring group of men, intent on
running an evil corporation with blind greed. They had not meant to render their customers infertile or allow women to pass away. But their actions were often irresponsible and deceitful, and although they lacked the intention to hurt women, at least four percent of Dalkon Shield users were injured.4 It is worth noting that if four percent of users were harmed, and roughly three percent became pregnant while using the Dalkon Shield, then the remaining 93% of women may have been
4 By Robins’ own estimate, 4% of Dalkon Shield users were injured from device related complications. Morton Mintz, At Any Cost (New York: Pantheon Books, 1985), p. 7.
12 satisfied with their Dalkon Shield experiences. Their positive stories are important,
but the flaws of the device and resultant turmoil had a greater impact on American
contraception. Their injuries resulted from the decisions of Davis and the A.H.
Robins Company. However, this harm could not have occurred without the social
conditions of the 1970s.
A lack of government protection for consumers created the atmosphere that
allowed this improperly tested medical device, the Dalkon Shield, to be marketed.
Corporate irresponsibility and the refusal of Robins’ officials to acknowledge that
their device was badly designed accounts for the story of a medical device that left
thousands of women mired in court cases, at least 17 dead, and an unknown
number infertile.
Dr. Hugh J. Davis was the Director of Family Planning Services at the Johns
Hopkins Hospital and an associate Professor of Obstetrics and Gynecology at Johns
Hopkins University. 5 These prestigious positions enabled Davis to test the experimental Dalkon Shield in individuals in both clinical and private practice settings. Women, thinking their physician must be among the best in the field to
have such prestigious credentials, trusted Davis to give them excellent health care.
They had no idea he was testing a new intrauterine device on their bodies in order to render financial profit, or that he was a dishonest and mentally unstable medical practitioner.
5 Hugh J. Davis, Intrauterine Devices for Contraception: The IUD, (Baltimore: Williams and Wilkins, Co, 1971), title page.
13 II. Historiography
Many disciplines, including sociology, law, business, and journalism have addressed the Dalkon Shield as a significant moment in contraceptive history.
Professional historians have remained curiously silent on the subject of this IUD.
There have been few historical articles or book pages devoted to the subject and absolutely no synthesized works of professional history. This lack of fair and balanced historical work into the subject matter has meant that all intrauterine devices bear this black stamp, and they remain an underutilized form of birth control in the United States as compared to other countries. A historical account that could focus on the ways in which the Dalkon Shield’s harmful effects were an anomaly could benefit the historiography of intrauterine devices as a whole and give a more accurate picture of the damage that this IUD caused.
A lack of primary sources cannot possibly be the reason for this oversight on the part of historians. Any book or article search will turn up a wealth of newspaper articles and first person experiences. The sheer amount of media coverage of the proceedings insured that there would be many articles written and extensive television reporting done on the shield device. Large collections of pertinent documents can be found at the University of Virginia Law Library and Harvard
University. The absence of a synthesized historical account of such a sensational and publicized event is therefore puzzling, given the amount of primary sources available to both academics and to the public at large. One explanation for this oversight may be the relatively recent occurrence of the events. If that is the case,
14 then enough time has certainly passed for a historical analysis of the Dalkon Shield
to be written.6
Infuriated victims of the Dalkon Shield and investigative journalists have
authored most of the existing material on this story. While most of the information
they revealed was valid, none of this body of work has contained a careful social
analysis of the Dalkon Shield history. They were too close to the situation, both
temporally and emotionally, to analyze events in an unbiased manner. Morton Mintz,
an investigative journalist for The Washington Post, eventually combined his articles
into a book that identified the behavior of A.H. Robins as typical corporate greed and
malpractice.7 The explanation of the Dalkon Shield saga is not as simple as the greed of corporate executives. Robins’ officials made human errors with terrible
ramifications, without the leash of government legislation to control them, in a birth
control market that was all too eager to embrace any non-hormonal form of
contraception.
This thesis does not contain the stories of the Dalkon Shield users. Beyond
anecdotal information that will offer a clearer understanding of events, the story of
these women has already been told. Their painful experiences have been detailed in
books and articles they wrote themselves. The victims tell the Dalkon Shield saga
from their point of view; a story of women hurt by a medical device that never
should have been released into the consumer market. Additionally, this work will
6 Kathryn Goldberg, “With Only Pieces of the Picture: A Historiography of the Dalkon Shield” (term paper, History 250, Case Western Reserve University, Cleveland, November 2010). Some assertions and information were taken from this earlier paper and applied to the historiography portion of this thesis. 7 Mintz, 248.
15 not be able to encompass a global perspective. The Dalkon Shield was sold primarily
in the United States, but millions of women also had the device inserted in other countries. The breadth of this thesis cannot properly encompass their experiences or social context, and so I have limited myself to Dalkon Shield events that occurred within the United States.
Karen Hicks, an academic8 and a victim of the Dalkon Shield, documented the
harm caused to women by both the shield device and the ensuing litigation.9 The
negative experiences and suffering of the women is ably documented, but her book
lacks clarity as a historical account. Little attention is paid to the ways in which a
deficit of consumer protection contributed to the development of this flawed IUD.
The focus is on the callousness of Robins’ executives and lawyers, both defense and
plaintiff, that were involved in the litigation. Two other books, Nightmare by Susan
Perry and Jim Dawson and Unshielded: The Human Cost of the Dalkon Shield by Mary
F. Hawkins, also focus on the negative experiences women had with their shield IUD and during the ensuing litigation. Again, these books are not social histories. These works do not place the decisions of the actors into the applicable cultural context,
although the works revealed valuable information about the trauma that a large number of women suffered from the use of the Dalkon Shield.
The Dalkon Shield litigation has been thoroughly analyzed. Lawyers and legal historians sought to understand the legal precedent of a class action lawsuit that
8 Karen Hicks is an adjunct Professor of Women’s Reproductive Health and Human Sexuality at Lehigh University and Lafayette College. 9 Karen Hicks, Surviving the Dalkon Shield IUD (New York: Teachers College Press, 1994), 11.
16 involved thousands of women and spanned several decades.10 These books, as
valuable as they are, provide an instrumental history. They study the story of this
IUD as it applies to tort law, and as such an understanding of social framework is
lost. The beginning of a story can be as interesting as its end. The Dalkon Shield’s
rise to popularity is just as important as its very public rise to infamy in the
courtrooms of Richmond, Virginia. The promise of the Dalkon Shield began when
doubt was first cast on the safety of the birth control pill.
Chikako Takeshita has written a feminist history of global IUD use from the
year 1960 through 2000. Her book grapples with the question of who truly controls
contraception. Takeshita focuses on the way that technology has been used as a
coercive means to control the health and sexuality of women in both the global
North and South.11 However, she also acknowledges that women have used IUDs to control their own fertility, in an independent and feminist manner. These devices are therefore versatile, and can mean different types of control to men or women.
Takeshita addresses the Dalkon Shield story in four short pages, but does not emphasize the government failures or social conditions that allowed a shoddily designed device to become so popular.12 Her story is repetitive of the existing body
of literature on the Dalkon Shield, which seemingly focuses more on outrage than
historical accuracy.
10 Ronald J. Bacigal, May It Please the Court. (Lanham: University Press of America, 1992) and Ronald J. Bacigal, The Limits of Litigation: The Dalkon Shield Controversy. (Durham: Carolina Academic Press, 1990). 11 Chikako Takeshita, The Global Biopolitics of the IUD, (London: The MIT Press, 2012), 1-32. I was unable to read this book in whole due to its recent release date. However, I was able to review the sections more pertinent to this thesis. 12 Takeshita, 75-78.
17 In Devices and Desires, the professional historian Andrea Tone came the
closest to telling the social history of the Dalkon Shield. She used considerable primary evidence, including Mintz’s book, corporate documents, medical publications, and newspaper articles from the period. However, the number of
communications from corporate executives or Dalkon Shield users is limited in her
account.13 There was no replacement for going to the archives at the University of
Virginia Law Library and reading these communications firsthand. Tone was forced to rely more on the publications tinted by public outrage than on first hand accounts.
She was also only able to devote a portion of the final chapter to the Dalkon Shield story. A full social-historical accounting of events, from beginning to end and in detail, would be a significant contribution to the historiography of contraception.
As evidenced by Tone and Takeshita’s books, the historiography of contraception has showed increasing interest in technological objects in the past fifteen years. Objects like pessaries, diaphragms, condoms, cervical caps, and IUDs are all advancements in the field of birth control. Historians of contraception are primarily grappling with the issue of who controls these objects and their usage. It is difficult to see whether governments and men are using the devices eugenically, or if women are using them to control family size and express their sexuality. Perhaps the answer is some combination of these two options.
This thesis will offer a new social aspect to the historiography of the Dalkon
Shield. There is a large amount of information available on the shield IUD, but only a
small amount of that is historical. There have been several feminist, law, and
13 Andrea Tone, Devices and Desires (New York: Hill and Wang, 2001), 349-352.
18 journalistic accountings of the events. Despite the contributions of previous writers,
a medical history that places the Dalkon Shield story in its political and social
contexts is still needed. I will demonstrate that government legislation and gender
norms created the ideal environment for this subpar medical device to be sold on
the consumer market. This does not take away from the fraudulent acts of individual
researchers and corporate employees. While society may have been lacking in
protection for female patients, these men remain personally responsible for the
damage they inflicted on the bodies of thousands of young, hopeful women.
A Brief History of Contraception
Women had long controlled the process of pregnancy and childbirth in the
United States. Home remedies, condoms, and female midwives dominated the field
of reproduction until the 1880s or so, when physicians involved themselves in the
process of childbirth, and consequently, the prevention of childbirth. Andrea Tone
tells the history of American experiences in making, buying, and using birth control
in the 1900s. 14 This technological and industrial perspective is particularly
applicable to the history of the Dalkon Shield that will be told in this paper.
The reproductive choices of young men and women often conflict with widely-held moral views. The government response to contraceptives such as diaphragms and condoms was a smattering of restrictive laws. The Comstock Law, which forbade the distribution of contraceptive devices and material via post, is one such example. As a result, birth control was an unregulated and illegal affair for
14 Tone, xvi.
19 nearly a century.15 This lack of government regulation would be replicated in the lack of consumer regulation provided for users of the Dalkon Shield.
The process of medicalization, the passage of time, and public demand brought gradual acceptance to contraceptives. There was growing desire for population control in the wealthiest classes and among politicians. Their desire was the result both of Malthus’ work and a deep fear that poor minorities would become the majority. These population concerns led to a renewed interest in intrauterine devices.16 There is a distinct lack of patient involvement in her own fertility after a physician inserts an IUD. Once this birth control device is in place, a woman needs to speak with a physician, and undergo a removal procedure, in order to have her fertility restored.17 The method therefore held great appeal to many male physicians
as an inexpensive method of population control. The IUD gave them a considerable
amount of power over female fertility. But before the IUD gained a following, the
reputation of the birth control pill became quite tarnished.
III. Development
The Fall of The Pill
Enovid was a medicine that consisted of synthetic hormones. Originally,
many American physicians prescribed it to treat menstrual disorders. The Food and
Drug Administration approved Enovid for use as a contraceptive in 1961, but
women in the United States had already been using the drug as an off-label
15 Ibid., xvii. 16 Ibid., 259. 17 Takeshita, 2.
20 contraceptive since its first issue.18 While a controversial subject, many young
women heralded this announcement as a chance for a new future. The birth control pill could provide protection from pregnancy on an almost perfect scale, and required no action be taken immediately preceding the act of intercourse. Women would be able to limit family size, pursue careers outside of the home, and control their own sexuality.
However, no new medical development is perfect. Many in the scientific community saw the deadly side effects, such as thromboembolism and cardiovascular disease, as serious risks.19 Their willingness to risk the health of young women on a potentially dangerous hormonal medication was waning.
Evidence cataloging these events began to accumulate in medical journals in the mid-1960s.20 Physicians began to take note of these serious allegations. Many became disillusioned with the Pill. The stage was being set to make inert IUDs, free of lab created hormones, the birth control of choice among American women.
Dr. Davis not only agreed with the evidence against oral contraceptives, but he actively drove the anti-birth control pill movement in public spheres. He spoke at
Senate Hearings bemoaning the lack of knowledge and consideration being provided to patients.21 He reiterated the health risks associated with a woman
18 Ibid., 226-228. 19 “IUDs Challenge Status of the Pill.” World News, 20 September 1968, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library. 20 “Contraception II: Dangers of the Pill,” Science News, 3 February 1968, http://www.jstor.org/stable/3953178. 21 Testimony of Dr. Hugh J. Davis, U.S. Senate, Subcommittee on Monopoly of the Select Committee on Small Business, Competitive Problems in the Drug Industry: Present Status of Competition in the Pharmaceutical Industry; Oral Contraceptives,
21 consuming high dose or sequential hormone contraceptive pills. At one point,
Senator Gaylord Nelson pointed out that Davis was referring to unreviewed
research still being conducted in Britain in his efforts to disparage the pill. Despite his lack of scientific proof, Davis assured Senator Nelson that the pills being analyzed at the hearing posed a serious health risk to female users.
Davis spent a considerable amount of time discussing the dangers, both real and imagined, of the birth control pill. He was quoted in Time Magazine as saying,
“Every important agent which has a carcinogenic [cancer-causing] effect in humans has been shown to cause cancer in animals. There is no reason to presume that the single exception will turn out to be the oral contraceptives." 22 Time’s writer argued
that these comments were unsubstantiated and lacked scientific proof. However, the
magazine did inform readers of proven oral contraceptive dangers due to blood clots, stroke, and several smaller side effects such as weight gain. Davis was not above making unproven claims in his efforts to ruin the reputation of the birth
control pill. Playing on cancer fears was a simple way for him to accomplish that
goal. If he managed to succeed in decreasing the popularity of the Pill, he would be
able to market IUDs more effectively.
One book in particular expressed the growing disenchantment for the Pill.
Barbara Seaman, a women’s health activist and journalist, wrote The Doctor’s Case
Against the Pill. Seaman called for informed consent among oral contraceptive users,
encouraged the use of alternative birth control methods, and discussed the health
91st congress, 2nd session, (Washington D.C.: Government Printing Office, 14 Jan 1970), 5929. 22 "The Pill on Trial." Time 95, no. 4 (January 26, 1970): 62. Academic Search Complete, EBSCOhost (accessed April 3, 2012).
22 dangers the Pill entails. 23 Davis once again found a platform for his anti- contraceptive pill statements. He wrote the foreword of Seaman’s book, extolling her honesty and willingness to tear the mask off of such a dangerous medicine.
Additionally, Seaman encouraged women to explore Davis’ intrauterine device of choice, which was the Dalkon Shield.24 The Nelson Pill Senate Hearings followed
soon after the book’s publication. After being revealed to the public as dangerous to
cardiovascular health, the consumer market was ready to replace the Pill with a
different form of birth control. They hoped to find a medication or device that would
be just as effective as Enovid, but devoid of the systemic health risks.
Despite these serious medical complications, the Pill was highly effective
against pregnancy. It would thereby set the bar for any subsequent contraceptive
methods. Users came to expect a pregnancy rate hovering around one percent from
their contraceptive method. Since hormonal birth control was being looked upon as
a possible cause of cancer and cardiovascular disease, developers of the
traditionally unpopular IUD saw an opportunity to market their devices. Also,
researchers saw IUD use as a form of population control with great potential to
stymie the world’s uncontrolled rate of human reproduction. 25 A medical
professional controlled the insertion and removal for IUDs, and the woman did not
need to participate in her own protection. There was less chance of patient error in
23 Barbara Seaman, The Doctor’s Case Against the Pill, (P.H. Wyden, 1969), 3. 24 Ibid. 25 John D. Rockefeller, “Intra-uterine Contraception: Proceedings of the Second International Conference,” The Population Council, (New York City, October 1964), Accessed from the FDA Biosciences Library, Baltimore MD, 21 July 2011, p 1.
23 that method than the Pill, which a woman needed to remember to take everyday and pick up her prescription.
The Food and Drug Administration oversaw safety and efficacy controls for medications in the United States. However, it did not have any jurisdiction over inert
IUDs. They abided by a strict ‘no drug – no contraceptive’ ruling.26 Until the FDA became aware that a medical device had harmed a consumer, they had no power to investigate or take action against device developers or pharmaceutical companies.27
This meant that intrauterine device designers, such as Davis, did not have to seek government approval or follow strict guidelines prior to device testing and distribution. They were free to mold and shape the plastic in any manner they wished and then insert them into patients of their private practices and family planning clinics. There are no records to indicate that these patients were told their
IUDs were untested in human or animal subjects. Most consumers were unaware that medical devices were out of the FDA jurisdiction. But, it is likely they assumed that products like the Dalkon Shield were under government regulation given their intimate nature and contraceptive qualities.
Many agents of the government were aware of the need for intrauterine device legislation. Beginning in 1962, Presidents Kennedy, Johnson, and Nixon sent consecutive messages to Capitol Hill calling for laws governing medical device use,
26 Ellen J. Preston to Kenneth Moore, memorandum, ‘Work with Copper and Dalkon Shield,’ 20 September 1972, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library. 27 Senator Edward M. Kennedy, Medical Device Amendments Senate Committee Hearing, 14 September 1973, (Washington D.C.: Government Printing Office), 2.
24 safety, and efficacy.28 Continuing calls for legislation came from the FDA’s special
Advisory Committee for Obstetrics and Gynecology, a group convened to address gynecological health issues.29 This committee warned that IUDs had mortality and
morbidity implications, and as such immediate government regulations of their
safety and effectiveness should be implemented immediately. However, no laws
were forthcoming. Without press coverage or sufficient public awareness of IUD
complications, legislators failed to act on medical device legislation. Despite the
clear need for device regulation, Congress did not pass the proper laws.
By Design
The Dalkon Shield was not Dr. Hugh J. Davis’ first foray into intrauterine
device design. In 1964, he and Edmund Jones designed the Incon Device. Due to
Davis’ agreement with Johns Hopkins University, he was required to defer his patent
rights on the Incon Device to the university.30 The device never became popular
outside of the Baltimore area, but the entire process taught Davis a valuable lesson
in patent law. He realized that Johns Hopkins would receive the lion’s share of any
profit he made from working with intrauterine devices, because the research and
development was occurring at the expense and in the offices of the university. Davis
became interested in designing and producing an intrauterine device that would not
be prone to expulsion in women who had never had children. Thus, he patented a
28 Mintz, 54-55. 29 Ibid. 30 Deposition of Dr. Hugh J. Davis by Mr. Post, Date Unknown, Vol. I – II, Reel 43, Dalkon Shield Claimants Trust, University of Virginia Law Library.
25 new ‘shield’ type device in 1967. 31 Davis shaped the IUD to fit snugly in the uterine
cavity, with plenty of surface area to come in direct contact with the inner uterine
walls.
After the shield device had been almost completely designed, Davis conferred
with Irwin Lerner, an electrical engineer, in order to finalize the design of the fins.32
Davis and Lerner devised downward pointing fins. The fins would then become
wedged in the endometrium whenever the uterus contracted in an attempt to reject
the foreign object. The fins could thereby prevent a partial or complete expulsion.
An attached string trailed from the bottom of the device down through the vaginal
canal. This string was used to check IUD placement and to facilitate the eventual
removal of the Dalkon Shield. Irwin Lerner alone applied for a patent on this
modified version of the same device Davis had designed in 1967. Figure 3, below,
depicts a Dalkon Shield with its characteristic downwardly pointing fins.
31 Mintz, 27. 32 Transcript of Witness Hugh J. Davis, 13 Jan 1975, Document 1852, Reel 26, Dalkon Shield Claimants Trust, University of Virginia Law Library.
26
Figure 3, Image taken by Kathryn Goldberg at the University of Virginia Law Library
If Davis were listed as the inventor of the Dalkon Shield, he would have had
to share the profits with Johns Hopkins, and patent ownership of the device would have belonged to the University.33 However, Lerner and Davis came to an agreement to circumvent this costly problem. Lerner was listed as the sole inventor of the
Dalkon Shield on the patent application, and he agreed to pay Davis a 5% consulting
fee for as long as Lerner Laboratories continued to sell the IUD.34 It is clear that
33 Deposition of Dr. Hugh J. Davis by Mr. Post, Date Unknown, Vol. I – II, Reel 43, Dalkon Shield Claimants Trust, University of Virginia Law Library. 34 Irwin Lerner to Hugh J. Davis, 10 June 1968. “Lerner Laboratories.” Reel 22, Dalkon Shield Claimants Trust, University of Virginia Law Library. Also, the Memo of Invention dated 12 September 1973 lists Davis as the designer of the Dalkon Shield and contains express permission for Dr. Yu, a Robin’s physician, to alter the design of the device in order to make it a synthetic hormone bearing IUD.
27 Lerner was not the sole creator of the device, and quite probable that Davis was
indeed the primary developer of the shield device. There are several instances in which other physicians let slip that Davis was the actual inventor of the shield device. 35 Davis’ principal involvement in the Dalkon Shield design and early production was common knowledge among many of the physicians in contact with, or the employ of, Robins. After product development was complete, Lerner, Earl,
Cohn, and Davis formed the Dalkon Corporation.36 Drs. Earl and Cohn were peers of
Davis, and the four men decided to found the Dalkon Corporation together. ‘Dalkon’ is clearly a combination of the founders’ names: DA (Davis) L (Lerner) KON (COHN).
The term ‘shield’ came from the protective connotation of the word and the devices’ resemblance to a policeman’s badge. Under this name, their company began producing devices and selling them on a small scale.
Dr. Hugh J. Davis began experimenting with intrauterine devices on both his private Johns Hopkins’ family practice patients and in the Planned Parenthood Clinic of the greater Baltimore area. Many of the women in the Baltimore group were poor
African American women.37 The research was conducted on these women before
35 A.N. Chremos to Files, memorandum, 3 February 1971. “Report of visit to Dr. Hugh J. Davis,” Reel 17, Dalkon Shield Claimants Trust, University of Virginia Law Library. 36 Memorandum to file, “Dalkon Shield – Purchase,” 10 June 1970, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library. 37 A.N. Chremos, Report of visit with Dr. Hugh T. Davis, Reel 17, Dalkon Shield Claimants Trust, University of Virginia Law Library. There was a typing error on the document and it should read ‘Dr. Hugh J. Davis.’ The Planned Parenthood study where Davis conducted his trial is characterized as being “downtown.” The individuals using this clinic were no doubt young, and many were members of minority groups, all taking advantage of the discount services offered by physicians such as Davis. It is unlikely they knew, however, that Davis was experimenting on them with untested intrauterine devices.
28 any safety or efficacy trials were conducted on animals. It seems that the health of
women in general, and this group in particular, was not important enough to protect
by conducting animal testing prior to conducting human research trials.
Additionally, testing a medical device on such a vulnerable group skewed the results of the research trial. During this period, some male physicians were likely to gloss over female discomfort or complaints. 38 In this unfriendly environment, it is
understandable that African-American women would be less likely to step forward
if they became pregnant on the Dalkon Shield or were experiencing side effects. The
pregnancy rate of the Dalkon Shield would have appeared lower than it actually was
in this group of patients.
Indeed, intrauterine devices were seen as the ideal contraceptive for poor
and minority women. The birth control pill, which Margaret Sanger had hoped
would alleviate the burden of large families from the indigent, turned out to be more
popular among middle class white women. In campaigning against the Pill, Davis
claimed that the medical community needed to develop a birth control method more
properly suited to the needs of inner city women.39 He was, of course, speaking of the potential of the IUD to provide population control to the socioeconomic classes the government most wanted to regulate. This goal of preventing pregnancy in individuals of low socioeconomic status was eugenic in nature. Additionally, Davis was implying that inner city women, mainly African-Americans, could not be
38 An excellent example can be found in the following source. Dr. Fletcher B Owen to Mr. John L. Burke, memorandum, 22 February 1971, Reel 16, Dalkon Shield Claimants Trust, University of Virginia Law Library. In this memo, Dr. Owen explains that it is sometimes necessary to administer painkillers to patients that are acting troublesome, and mentions that Dr. Davis also shares this viewpoint. 39 Tone, 259.
29 counted on to take or use birth control reliably. His assertion was that the indigent
poor could not be trusted to prevent pregnancy, so someone needed to do it for
them.
Davis’ research trial was deeply flawed in more ways than the subjects’ racial
and financial vulnerabilities. Dr. Russel J. Thomsen, a physician at the United States
Army Hospital in Fort Polk, Louisiana, wrote to A.H. Robins to inform them that the
four studies quoted in Dalkon Shield advertisements (trials conducted by doctors
Davis, Earl, Ostergard, and Gabrielson) reported misleading figures. Thomsen’s
analysis of the studies showed that the Davis research trial on the Dalkon Shield was
the least accurate of all the quoted studies.
Davis’ study covered a time period of 12 months with 640 insertions and 3,549 woman-months of use. This simply means that the study covered 640 insertions with the average time used by each insertion being only 5.5 months. Earl’s study covers a little more time (8.6 months average insertion time), but Ostergard and Gabrielson give pathetic average insertion study time of only 4.3 and 4.9 months respectively. Need I point out that the grand average of your four quoted studies involving 3,174 insertions covering 17,222 woman- months gives an equally pathetic average insertion study of only 5.4 months. In your own ad you suggest “A supplemental contraceptive method… during a 2-3 month post-insertion adjustment phase.” If that three month period is subtracted… one comes to the startling conclusion that you are selling this product with an ad that really makes claims based on a partial guarantee covering only about 2.4 months of average time during which the Dalkon Shield is the only form of contraceptive recommended.40
40 Dr. Russel J. Thomsen to the Professional Services Department of A.H. Robins Company, 15 December 1972, Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library. The emphasis is my own.
30 Davis reported having 640 women in the study, but he does not appear to have
accounted for women who dropped out of the trial. He never mentioned a dropout
rate in his publications or communications. 41 This number would have been
important, given that pregnancy or injury were common reasons women left birth
control trials.
Dr. Ellen J. Preston, a physician in the employ of A.H. Robins, wrote that in
order to properly analyze contraceptive effectiveness, a woman should wear the
IUD in question for ten months.42 It is unfortunate that Robins’ officials did not follow their own research trial advice. If Preston had understood that Davis’ 5.5-
month average was nowhere near the 10-month average recommended, perhaps
she would have questioned the wisdom of trusting his birth control research results.
Later, Davis confessed to having advised his private practice patients to use
spermicidal foam while they had the Dalkon Shield in place. 43 This provided
additional protection against pregnancy, and further skewed the results Davis
reported from the research study.
Though the Dalkon Shield was Robins’ first foray into birth control, they had not planned on it being their last. In 1973, they developed a spermicidal foam they dubbed ‘Dalkon Foam.’44 Although the Dalkon Shield fell from popularity before
41 Mary F. Hawkins, Unshielded: The Human Cost of the Dalkon Shield (Toronto: The University of Toronto Press, 1997), 14. 42 Ellen J. Preston to Foy Langford, 30 November 1971. “Dalkon Shield – Publication of Data,” Reel 24, Dalkon Shield Claimants Trust, University of Virginia Law Library. 43 Mark Dowie, Mother Jones Magazine, November 1976, Reel 9, Dalkon Shield Claimants Trust, University of Virginia Law Library. 44 Product Status Report, Dalkon Foam, 3 April 1973, Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library. Also, “Use of Adjunctive
31 aggressive sales of the foam could begin, it was always planned that the spermicide
should be sold for use in tandem with the device. Use of the foam was especially encouraged during the first 2-3 months of Dalkon Shield use, as the company’s physicians advised in the advertisement mentioned above. Through sales of the foam, Robins executives would be able to turn a one-time intrauterine device sale into a continuously profitable venture. They did not see the use of foam as a failure of the Dalkon Shield’s efficacy. Rather, they saw the selling of foam as an opportunity to increase profits.
Additionally, tandem use of the foam and the shield would make the device appear as effective against pregnancy as sellers claimed. In fact, Davis said that “if complete protection is desired, advise her to apply a spermicidal foam prior to intercourse to add to the protection of the IUD.”45 There is considerable evidence that during his Dalkon Shield research study, Davis recommended the use of foam before sexual intercourse “from Day 10 to Day 17” in private practice patients, because they would likely desire total protection from pregnancy.46 Davis himself told Dr. Harold Aaron that this use of contraceptive foam was one of three reasons that the pregnancy rates in Davis’ patients were so much lower than in Aaron’s patients.47 Spermicide use would have skewed Davis’ results, because his patients would have been using two contraceptive methods, but reporting a pregnancy rate
Contraceptive Methods.” 27 July 1971, Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library. 45 Davis, 135. 46 Hugh J. Davis to George A. Saxton, Jr, 24 March 1971, p 2, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library. 47 Hugh J. Davis to Harold Aaron, 1 November 1972, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library.
32 for the Dalkon Shield alone. The shield device would have appeared to be far more
effective than it truly was at preventing pregnancy.
The Dalkon Shield was more painful than any other IUD on the market. The
device design was developed with expulsion prevention in mind. The fins were
meant to dig into the uterine walls, rather than allow the human body to reject the
device. However, intrauterine devices did require eventual removal from patients,
whether due to a patient’s desire for pregnancy or a different method of birth
control. An independent researcher, Robert A. Erb, performed tests to discover the
“Forces Required for Installation and Removal of Dalkon Shield IUD’s.”48 Erb found
that “high force levels for insertion and removal” of the Dalkon Shield were required,
and the force required to install a shield was almost ten times that of the Lippes
Loop, which used a soda straw inserter. The force to which they are referring is the
amount of strength it takes to open the cervix, a relatively tender and sensitive
organ, and allow the IUD to slide in and be placed in the uterus. This leads to the
logical conclusion that the Dalkon Shield insertion and removal process was far
more painful than that of the Lippes Loop, because it was so much more forceful.
These women experienced needless suffering. If their physicians had inserted a
Lippes Loop instead of a Dalkon Shield, they would have received a device of similar
efficacy, increased safety, and a less agonizing insertion.
Often, certain physicians and pharmaceutical companies failed to take the
pain of female patients into account. They thought some of the distress a woman
48 Robert A Erb to A.H. Robins Company via Howard Balin, “Research Note No. 1: Improved Intrauterine Devices,” 9 April 1973, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library. The Lippes Loop was a popular IUD before and during sales of the Dalkon Shield.
33 expressed during insertion was the ‘imagined’ result of hysteria.49 Hysteria was once a common medical diagnosis in women that were considered troublemakers. 50
It was thought that a malfunctioning uterus caused the ailment, so it is ironic that
IUDs are placed in that particular organ. Hysteria was a diagnosis used for a variety
of mental illnesses in women as defined by male psychiatrists. The failure of some
physicians in the 1960s to acknowledge the discomfort of their female patients was
a holdover from this common diagnosis of hysteria in earlier centuries. Their pain
was seen to be a mental deficiency rather than actual suffering.
In Intrauterine Devices for Contraception, Davis mentions that the
paracervical block can be used to prevent ‘cervical shock’ during insertion, a
vasovagal nervous system reaction that can result from forceful contact with a nerve
in the cervix, but Davis does not ever suggest that the cervical block can be used for
pain management.51 Admitting that the Dalkon Shield caused deep pain would have cast a shadow on his perfect ‘second generation IUD’. Davis suggested that inserting the IUD during menstruation could prevent most of the complaints of IUD insertion, including pain. “Since the patient is already bleeding, the insertion procedure will cause little additional inconvenience.”52 Davis was incorrect. It was not the bleeding that bothered women during the insertion, but rather the extreme amounts of power required to force their cervix open. This was a common problem of having
49 Fletcher B. Owen to Mr. John L. Burke, 22 February 1971, “Dalkon Shield Insertion, Nulliparous Patients,” Reel 16, Dalkon Shield Claimants Trust, University of Virginia Law Library. 50 Elaine Showalter, The Female Malady: Women, Madness, and English Culture 1830– 1980, (New York: Pantheon Books, 1985). 51 Davis, 128. 52 Davis, 126.
34 male doctors working on women’s health issues. Being unable to relate to female
discomfort made male doctors less able to care about pain management for their
patients.
The employees of A.H. Robins Company failed to see the pain of the
nulliparous53 patient as a reality. Most physicians, as previously mentioned, also
ignored the complaints of pain. However, a few physicians wrote or called to report
that Dalkon Shield insertions were intolerably painful for many of their patients.54
Robins’ executives and medical personnel discounted these reports. Rather than reconsider their device or insertion procedure, they warned doctors to anticipate a
“tense, anxious, nervous nullip” with a bad case of “over-reactivity,” rather than a human being experiencing real pain.55 Nowhere does the writer of this memo, a physician of Robins named Fletcher B. Owen, acknowledge that even a small-sized56
Dalkon Shield insertion might be an excruciating process for a woman who has
never had her cervix and uterus stretched open during childbirth. Rather, Owen
blames insertion-pain on the negative mindset of the patient. Davis’ and Owens’
descriptions of young women were not only ignorant but also insulting in their attempts to deflect the cause of pain away from the intrauterine device. In the same
53 ‘Nulliparous’ means that a woman has never carried a pregnancy to term. The word is particularly important in reference to intrauterine devices because women who have carried a child have a slightly larger uterus. 54 Dorothy I. Lansing to Frederick A. Clark, 23 August 1974, Reel 23, Dalkon Shield Claimants Trust, University of Virginia Law Library. 55 Fletcher B. Owen to Mr. John L. Burke, 22 February 1971. “Dalkon Shield Insertion, Nulliparous Patients,” Reel 16, Dalkon Shield Claimants Trust, University of Virginia Law Library. “Nullip” in this quote is an abbreviation of the word nulliparous. 56 There were two sizes of Dalkon Shields. One was for women with a larger uterus, generally those who had already had a child, and the smaller device was for nulliparous women. It was thought that the smaller Dalkon Shield would be better tolerated in the nulliparous uterus.
35 memo, he recommended the use of medical painkillers only if the physician was
dealing with such a high strung patient.57 Owen refused to validate the physical pain cause by an invasive procedure and wrote as though the painkilling medicine was only needed to make the physician’s work easier. The painkiller could soothe a troublesome patient.
Although there were no laws barring poor research methodology, there were norms of intrauterine device research that Davis should have followed in his study.
Dr. Christopher Tietze, another physician heavily involved in innovative IUD research, wrote a description of a proper IUD research trial. 58 He explained how to run the study and then calculate the results using a woman-month method. The woman-month method was the only established, accurate way to run an IUD trial.
Tietze had set the scientific precedent for running a research trial properly, and
while Davis used the woman-month method, he did not conduct his trial or calculate the results precisely as Tietze had outlined. There were not enough woman-months
per trial patient, and Davis did not allow for that when he was calculating the final
statistical data. Or, it is even possible that Davis had tampered with the data,
committing an act of scientific fraud. We lack positive proof to that effect, so the two
possibilities remain. Either Davis made several errors in his research trial, or he lied
about the resulting figures.
57 Ibid. 58Christopher Tietze, Intra-Uterine Contraceptive Devices, Proceedings of the conference, April 30 – May 1 1962, New York City. “Intra-Uterine Contraceptive Rings: History and Statistical Appraisal,” p 12. Accessed from the FDA Biosciences Library, 21 July 2011.
36 A.H. Robins Company
A.H. Robins was a pharmaceutical company that presented itself as having
down to earth, Baptist-based corporate values. Founded in Richmond, VA in 1873, the company aimed to have ethical intentions from the start.59 Their values and
business approach were based on religion and wholesome behaviors.60 This created
a feeling of righteousness in their financial endeavors. If their intentions were
always based in goodness, then they assumed they would always do right by their
customers. The spirituality that Robin’s officials projected onto the pharmaceutical
company gave A.H. Robins a supposed purpose beyond simple corporate greed.
Wholesome values made the workers of Robins feel more like a family than a set of employees; they were a group of people providing beneficial services to a public in need of health related goods.
A.H. Robins had no previous experience with producing or selling birth control. They knew they were entering a new medical area and wanted to begin the venture with the best IUD available.61 They were excited by the prospect of a low pregnancy rate and knew physicians and women would be tempted by the excellent research figures Davis had rendered. They brought their leading salesmen to
Richmond, Virginia to be trained in birth control facts and Dalkon Shield sales tactics. They thought the device would be the best on the market in reference to failure rates, and wanted their salesmen to properly communicate that fact to
59 Virginia Historical Society, “A Guide to the A.H. Robins Company Records, 1885– 2004.” Collection Number Mss3 R5535 a FA2, Richmond VA. 60 Mintz, 45-55. 61 John L. Burke to all Regional and Divisional Managers, memorandum, 26 August 1970, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library.
37 physicians. The physician would decide which IUD their patient received, since a
medical practitioner could only insert a device that was stocked in their office.
Davis soon became a negative selling point. In the debriefing from the sales
mangers’ training session on November 23, 1970, those in charge of the debriefing
stated that “the name of Davis will get you kicked out of many doctor’s offices.”62 He
was not permitted to take part in the promotional Dalkon Shield videos and
salesmen were discouraged from mentioning him in their sales pitch. Davis was not
trusted in the medical community as an IUD expert. The exact reason is unknown,
but it is clear that other physicians found Davis personally and professionally
objectionable. It may be that his mental incapacity, which will be discussed later,
prompted a cold reception from his peers in the medical field.
A.H. Robins began research studies immediately after purchasing the Dalkon
Shield from the Dalkon Corporation. However, the company did not wait for results
to confirm Davis’ efficacious pregnancy and expulsion rates. They only performed
biological tests in order to determine the safety of the plastic in the IUD. Robins
conducted animal testing to confirm that there would be no living tissue response to
the plastic material.63 As such, the Dalkon Shield met U.S. requirements for plastics that would be used in human procedures. Although there were not many hoops for
Robins to jump through in the beginning, G.E. Thomas warned the President of
Robins, Mr. W.L. Zimmer III, that the status of medical devices in 1970 (i.e. free from
62 Training session debriefing, 23 November 1970, Reel Unknown, Dalkon Shield Claimants Trust, University of Virginia Law Library. 63 A.H. Robins Company, Department of Pharmacological Research. “U.S.P. XVII Biological Tests on Dalkon Shield Intrauterine Device.” 30 December 1970, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library.
38 government regulation) would not last long. He believed that such federal restrictions were imminent in the field of intrauterine devices. 64 Robins’ executives
were aware that while they need not submit Dalkon Shield efficacy and safety
testing to the FDA in 1970, the time would come when they would need to report to
the government. Thomas was nervous about the company’s decision to purchase the
Dalkon Shield from the Dalkon Corporation. Robins’ employees’ lack of birth control
market experience would leave them vulnerable to error and, later, to governmental
scrutiny.
E. Claiborne Robins had a long-standing fear of government intervention
affecting the company he had inherited from his father. He resented the idea that the
federal government might interfere with his family’s innovative progress. As
early as 1966, he spoke out against the federal regulation of pharmaceutical companies.
All about us, in all directions, lie threats to the free- enterprise system and the cancer of central government control. In the drug industry, we have already had our share – and we are promised more. It used to take us five years to introduce a new product; today it takes up to eight. Those three additional years can greatly increase the cost of a product, in addition to the delay in its use for mankind. Control is good only when it is helpful to the end product; excessive government control can only be a form of strangulation.65
64 G.E. Thomas to Mr. W.L. Zimmer III, 10 September 1970, Reel 22, Dalkon Shield Claimants Trust, University of Virginia Law Library, p. 2. 65 E. Claiborne Robins, The Story of A.H. Robins Company, (New York: Princeton University Press, 1966), pp. 15-16. This speech is from May 1966 at a Newcomen Society awards dinner. E. Claiborne Robins gave a speech on the history of A.H. Robins Company and was the guest of honor at this event, which took place in Richmond, VA.
39 Robins would not have been receptive to the United States government telling him how to test and monitor a medical device. It is apparent from his speech that E.
Claiborne Robins did not see the need for federally mandated pharmaceutical testing. He saw such an intrusion on the independence of his company as an expensive waste of time. The Dalkon Shield was a perfect example of an unregulated, poorly tested medical device that Robins could release onto the market for a swift profit.
The animal studies of Dalkon Shield efficacy did not begin until well after the human research trials had started. In September of 1971, A.H. Robins funded a two- year baboon study.66 This was eight months after national marketing of the modified
Dalkon Shield began, and well after Davis had concluded his initial human trials in
Baltimore. It is disturbing that both Davis and Robins’ researchers saw fit to test the
Dalkon Shield in women before they performed animal safety testing on this intrauterine device.
The lack of pre-sale research trials may have been due to the sexual nature of the Dalkon Shield. An IUD was not used to treat any existing disease, but only to prevent pregnancy. Dalkon Shields did not directly prevent death or improve quality of life like some other medical devices. Their main purpose was to enable individuals to have coitus without worrying about becoming pregnant. It may have been that a device with such a sexualized association was seen as an unlikely health hazard, because IUDs were unable to treat diseases. The IUD’s connotation was that of pleasure rather than that of a serious kind.
66 ‘Chronology’ from Source files, Reel 18, Document 210273, Dalkon Shield Claimants Trust, University of Virginia Law Library, p 2.
40 There is another reason the Dalkon Shield was not seen as a potential health
hazard. Many physicians could not see a basically inert intrauterine device as a
health threat. The Dalkon Shield did not cause stroke, heart attack, or
thromboembolism like the birth control pill did. Since the shield was only plastic,
and was not advertised as containing hormones or chemicals, it was seen as non-
threatening by prescribing physicians. Even though at least a few Robins’ executives were questioning the safety of the device, which would have been the only logical
reason for the baboon safety test, Robins’ officials could not admit to themselves
that their unregulated medical device could ever harm consumers.
The relationship between Robins and the Dalkon Corporation did not end at
the time of the sale. For some time, the Dalkon Corporation continued to produce
devices for Robins to sell, although Robins was displeased by production costs.67
Additionally, the members of the Dalkon Corporation continued to receive royalty
payments from Robins.68 There was a royalty clause in the sales agreement. The
Dalkon Corporation would receive 10% royalty for the life of the patent.69 This meant that for as long as the shield device remained on the market and the patent was valid, the owners of the Corporation would have a vested interest in the success of the intrauterine device.
67 Stuart L. to C.E. Morton, 28 July 1971, Reel 24, Dalkon Shield Claimants Trust, University of Virginia Law Library. 68 Robert E. Cohn to E.C. Morton, or Dalkon Corporation Secretary to VP of A.H. Robins Company, 21 July 1971, Reel 7, Dalkon Shield Claimants Trust Collection, University of Virginia Law Library. 69 Memorandum to file, A.H. Robins Company. “Dalkon Shield – Purchase.” 10 June 1970, Reel 7, The Dalkon Shield Claimants Trust, University of Virginia Law Library.
41 Davis received 35% of the profit the Dalkon Corporation made from his intrauterine device. Davis profited from the royalties of the shield device while hiding his profit-gaining role from both the public and the medical community. He submitted articles pertaining to his IUD research to medical journals, such as
Obstetrics and Gynecology. The editor of this journal agreed to publish the paper despite having serious reservations concerning the validity of the research.
“Frankly,” he wrote Davis, “your results are far better than the experience with the shield in many other clinics which may create discussion among our readers.”70
Davis was able to promote the Dalkon Shield, thereby profiting financially, despite
growing doubt in the medical community that his failure rates were valid.
Nationwide promotion of the Dalkon Shield began on January 2, 1971.71
However, the device that Davis had tested would not be the one produced and
inserted into women. Davis, Earl, Lerner, and Robins’ officials decided that after
making necessary design and product alterations they would only promote a new
and improved Dalkon Shield for sale.72 A.H. Robins knew that the IUD they would be
selling would be a different contraceptive than the one Davis had tested. This can
only be viewed as a fraudulent act. It did not matter that Robins assumed the failure
rate and adverse side effects of the new Dalkon Shield would be the same. Their
actions were a case of corporate irresponsibility, and they should have thoroughly
tested the new device prior to its release.
70 Richard F. Mattingly to Hugh J. Davis, 12 July 1972, Reel 7, Dalkon Shield Claimants Trust Collection, University of Virginia Law Library. 71 Deposition of Roy William Dent, Jr. Mid America Reporters deposition, page 17 of deposition, Document 187025, Reel 13, Dalkon Shield Claimants Trust, University of Virginia Law Library. 72 Ibid.
42 Robins’ executives became aware 2 days before they legally purchased the
Dalkon Shield that the original pregnancy rate, 1.1%, had increased to 2.3% with an extended observation of Davis’ study. 73 However, in all of their subsequent advertising, Robin’s continued to cite the earlier pregnancy rate of 1.1%. If a physician or potential customer asked for the failure rate of the shield, they were told it was 1.1%. This made the Dalkon Shield comparable to oral contraceptives. It was false advertising. Robin’s knew that the Dalkon Shield was not as effective as they claimed it to be, but as long as the intrauterine device was selling, they stood by the false figure Davis had given them.
The Dalkon Shield sales campaign was a convincing one. Robins was aware from the start that “physicians tend to use only one brand (or type) of IUD… physicians who are well satisfied with a given device, need a convincing argument to interest them in a new product.”74 Any promotional campaign would need to
convince satisfied physicians and patient, proponents of the Lippes Loop and similar
devices, that they were missing out on a superior product and source of pregnancy
protection. The heads of the sales division tracked the transactions of each salesman,
and salesmen were forced to communicate to their employers valid excuses if they did not produce satisfactory results. They received letters encouraging callbacks
73 Jack Fruend to Mr. E.L. Bender. “Comments Concerning the Dalkon Shield (IUD).” 11 June 1970, Reel 18, Dalkon Shield Claimants Trust, University of Virginia Law Library, 2. 74 David E. Jones and George J. Mancini, August 1970. “The Dalkon Shield, A Preliminary Market Study,” A.H. Robins Company, Reel 22, Dalkon Shield Claimants Trust, University of Virginia Law Library, p. 5.
43 and better follow through. 75 These salesmen repeated the information they had
been taught, and were aware that if they failed to successfully push the Dalkon
Shield, they would lose their livelihood. This type of incentive kept sales of the
Dalkon Shield healthy. The advertisement below is one of the strangest sales tactics
Robins employed. It depicts a disembodied uterus floating through outer space, with a Dalkon Shield comfortably nestled within. Meant to portray a sense of scientific advancement, this advertisement appeared in medical journals and was directed mainly at an audience of male physicians.76
75 E.D. Hood to Donald Leider, 21 June 1971, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library. 76 Hawkins, 19. I was unable to locate this advertisement in the medical journals. I have used a copy of the image found in Mother Jones Magazine in lieu of the original source. In the absence of these medical journals, I am taking Mother Jones at their word that this advertisement appeared where they claim it did.
44
Figure 4, “The Flying Uterus,” Courtesy of Mother Jones Magazine
Sales pitches at medical conventions often involved enticing physicians and
their wives by serving alcoholic beverages. It is clear that this behavior at
conferences was not only condoned, but encouraged; a salesman named Alvin
Jenkins filed for reimbursement for a bottle of scotch and a bottle of bourbon that
had been consumed by a group of physicians in Jenkins’ hotel room. 77 It is clear that the Dalkon Shield was not only sold on the basis of low expulsion and pregnancy
77 Alvin Jenkins to Duwaine Kaufman. “San Francisco Trip (AMA).” 24 June 1972, Reel 16, Dalkon Shield Claimants Trust, University of Virginia Law Library.
45 rates. Robins understood that cheerful, and perhaps tipsy, physicians could do a lot
for their sales margins. The better the physician rapport with the A.H. Robins
Company, the better off Robins would be.
Robins was very clear as to who needed to purchase the Dalkon Shield. The
‘nullip,’ ‘pill reactor,’ ‘clinic patient,’ and ‘disorganized woman’ were all excellent
candidates for the shield.78 These women either could not be trusted to manage their own birth control on a daily basis, or the only IUD their small uterus would tolerate would be the smaller sized Dalkon Shield, which had been designed with nulliparous women in mind. Robins followed the common prejudice that physicians should protect women from their own ineptitude. These women were not trusted to
effectively prevent pregnancy from taking place. However, if the physician inserted the Dalkon Shield, he would provide excellent protection to ‘helpless’ womankind.
The Dalkon Shield became popular quickly. By March of 1972, over 2 million insertions had been performed, and the Dalkon Shield had claimed 40% of the
United States IUD market.79 The advertising campaign, sales tactics, and touting of the imaginary 1.1% pregnancy rate were effective in convincing physicians to purchase the device. Women thought they were receiving a top-of-the-line birth control device because that was the lie A.H. Robins propagated, and the lie was working to the tune of a 40% market share. Robins’ employees noted that positive
78 Advertisement, “A Progress Report: Who are candidates for the Dalkon Shield?” Reel 20, Dalkon Shield Claimants Trust, University of Virginia Law Library. 79 George J. Mancini, National Review: Sales and Marketing, March-April 1972, Reel 20, Dalkon Shield Claimants Trust, University of Virginia Law Library, p. 1. The Lippes Loop had 33%, and the Saf-T-Coil had 22% of the market.
46 word of mouth from one woman to another was an important component of IUD
sales, as half of IUD insertions stemmed from patient request.80
Not all medical practitioners were sold on the shield device. The sinister
shape of the small object, often compared to a grappling hook or crab, was off-
putting to many physicians. The shape of the device was especially disturbing to Dr.
Dorothy Lansing, a female private practice OB/GYN. She refused to purchase the
Dalkon Shield due to the ‘gruesome’ appearance of the device. Lansing had a clear understanding of the difficulty the side fins would present to the removal process.81
As a woman, she may have been able to vividly imagine how painful the device
removal would be for her female patients. By her own account, when she refused to
purchase any of the devices, a salesman became belligerent and informed Lansing
that she would be the only physician in the area not inserting the Dalkon Shield.
The attempt to pressure Lansing into a purchase was unsuccessful. Nothing
could calm her instinct that something was flawed in the design of the Dalkon Shield,
and that women would be ill served by the “instrument of torture.”82 Lansing used
instinct and knowledge of female anatomy to protect her patients. Besides utilizing
her knowledge as a doctor, Lansing was acting as a strong woman to defend her
female patients, and she refused to be bullied by male salesmen. Lansing would not
blindly use medical devices designed by men, and she remained adamant that such a
frightening looking device would not be inserted into women at her medical practice.
80 David E. Jones and George J. Mancini, August 1970. “The Dalkon Shield, A Preliminary Market Study,” A.H. Robins Company. Dalkon Shield Claimants Trust Reel 22, University of Virginia Law Library, p. 4. 81 Dorothy I. Lansing to Frederick A. Clark, 23 August 1974, Reel 23, Dalkon Shield Claimants Trust, University of Virginia Law Library. 82 Ibid.
47 Physicians wrote to Robins in order to express their displeasure with the
shield device. Dr. Paul R. Packer called the Dalkon Shield “the most traumatic [act]…
ever perpetrated upon womanhood” and informed Robins that he had ordered all of
the devices from his office. 83 This physician had extensive experience with
intrauterine device insertions, and was still horrified by the amount of pain the
Dalkon Shield caused to women. He makes no distinction between his nulliparous or
multiparous patients, so it is safe to assume that he would not recommend the
device to any women, whether or not they had had a child, or even taken painkillers
before the procedure.
The Supramid string attached to the Dalkon Shield would become a
considerable issue for all parties involved – physicians, Robins executives, and most especially the female users of the device. The string was suture material from a
German company, but scientists and medical practitioners at Robins failed to
perform their own degradation testing on the string. This is unsurprising, because they also failed to test the device as a whole prior to releasing it. The String consisted of several hundred small fibers wrapped by a single sheath. This, unlike other IUDs on the market in 1970, made the Dalkon Shield string a multifilament attachment. The comppany was forced to use the stronger multifilament string due to the fins at the side of the IUD. The fins at the side of the device, so effective at preventing expulsion, made the removal process a horrific and challenging process.
The tensile strength of a monofilament was not sufficient to stand up to the pull exerted by an attending physician. The string would occasionally break off,
83 Paul R. Packer to A.H. Robins, 11 February 1971, Reel 20, Dalkon Shield Claimants Trust, University of Virginia Law Library.
48 necessitating the use of forceps or surgery to complete the removal process. The multifilament string could hold up better to hard pulling. However, studies show that the bundling which made the Dalkon Shield string so strong acted as a conduit for bacteria.84 Over time, holes appeared in the outside sheath, and bacteria climbed inside. Thriving in that warm, wet environment, they climbed from the vaginal canal to emerge in the sterile uterine environment in a process called ‘wicking.’85
Davis was aware of the dangers of wicking. In his book, Intrauterine Devices for Contraception: The IUD, Davis mentioned that wicking could provide a path for bacteria to climb into the uterus. Ironically, he was convinced that the fantastic ‘2nd
generation IUDs’, of which the Dalkon Shield was the best, was not subject to this
wicking problem.86 In reality, the Dalkon Shield would become the most notorious
IUD ever designed, and cause more infertility and spontaneous septic abortions than any other type of birth control.
The problems with the string did not go unnoticed by all of Robin’s employees. Not only was the multifilament prone to degradation and damage, but the material also had a partial opening at either end. The string was knotted, but it was entirely possible that bacteria was still able to move within the sheath of the knot and continue to wick into the uterus, then out the opening at the proximal end of the string. E. Wayne Crowder, a quality control supervisor at the Chapstick
84 Tietze, “Contraception,” April 1975 vol. II no. 4, p. 472, Reel 23, Dalkon Shield Claimants Trust, University of Virginia Law Library. 85 Wicking is a phenomenon seen in candles. As it applies to IUDs: bacteria were able to burrow through holes in the outer sheath of the Supramid string, and climb from the wet vaginal environment into the previously sterile uterus. Once there, they thrived in the damp and warm setting and the woman might develop into Pelvic Inflammatory Disease. 86 Davis, all pages.
49 factory where Dalkon Shields were assembled, approached his supervisor about the problem.87 Demonstrating a simple solution, Crowder used a lighter to seal either end of the string. Rather than implement this technique, or at the very least addressing the issue of an unsealed suture string in a bacterial environment, Robin’s officials chose to believe that the string openings were not a problem. Heat sealing
was never incorporated into the assembly process, and another opportunity for
bacteria to damage women remained.
Problems Emerge
Infertility or spontaneous septic abortions can result if the uterine
environment is colonized by bacteria and left untreated. Because the ends of the
Dalkon Shield string were left open, bacteria was able to wick itself from the vaginal
environment into the uterus.88 Once in the uterus, the infection would grow and
often develop into pelvic inflammatory disease. This condition could scar a woman’s
reproductive organs and leave her infertile. Spontaneous septic abortion was
another condition associated with the Dalkon Shield. If a pregnancy occurred, and
bacteria was wicked into the uterine environment, the bacteria could attack the
fetus and umbilical chord. This would sometimes result in fetal and maternal
mortality.
87 Deposition of E. Wayne Crowder, 24 May 1982, Reel 59, Dalkon Shield Claimants Trust, University of Virginia Law Library. 88 Howard J. Tatum. “Microbial Migration in the Thread Attached to an IUD as a Possible Factor in Infectious Complications.” The Population Council, 1975, pp. 411- 415, Reel 18, Dalkon Shield Claimants Trust, University of Virginia Law Library.
50 Robins’ own paid consultant, Dr. Thad Earl, passed along a warning to A.H.
Robins Company concerning his own IUD insertion experiences. Women that became pregnant while using the shield device would sometimes abort and become septic.89 This infection of the blood could kill both the fetus and mother. Earl
recommended accumulating more data on the spontaneous septic abortion
phenomena as it pertained to the Dalkon Shield. Robins’ executives claimed that this
letter was not sufficient warning to halt sales of the device, because these sepsis
events were so rare.90 While Earl’s letter to Robins’ officials was not enough to
correlate causation to the Dalkon Shield, executives should have listened to the
expert advice of a physician they trusted for all of their intrauterine device
information. It was his job to alert them to possible adverse side effects of the
Dalkon Shield, and they basically ignored his startling observations of a life
threatening condition in five pregnant women.
Letters from women or physicians reporting adverse events began to stream
into A.H. Robins Company. Husbands and boyfriends also wrote on the behalf of
women who were experiencing Dalkon Shield related medical trauma. David G.
Gueulette, one such husband, wrote an angry letter to Robins. 91 After conferring
with local physicians and the Planned Parenthood in Columbus, OH, he concluded
that women were experiencing pregnancies far in excess of the 1.1% Robins
89 “Answers given by A.H. Robins Company executives on questions concerning the Dalkon Shield asked by 60 Minutes correspondent Mike Wallace.” This document, written by A.H. Robins, includes information quoted from Earl’s letter written 23 June 1972. Question 3, p. 2, Document 186438, Reel 13, Dalkon Shield Claimants Trust, University of Virginia Law Library. 90 Ibid. 91 David G. Gueulette to A.H. Robins Company ‘Sirs,’ 18 January 1972, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library.
51 reported from Davis’ research. Geulette refused to believe the false statistics that the pharmaceutical company continued to propagate.
Often, the women politely asked for financial reimbursement upon device
failure. They saw the Dalkon Shield as defective, and were hoping that as a
responsible company Robins would issue them a refund for having sold a subpar
medical device. Mrs. Georgia H. Macomber92 requested $298.75 for the emotional,
physical, and financial stress that her pregnancy and subsequent medical abortion
caused her. Unfortunately, Robins’ officials had no intention of paying Macomber.
Fletcher B. Owen’s response was that A.H. Robins Company deeply regretted her
negative experience, but the Dalkon Shield was a leading IUD and a small failure rate
could always be expected.93 The refusal to reimburse was not due to a fear of opening themselves up to lawsuit. There was no awareness in their corporate memos to indicate that they expected the dissatisfied customers to sue them, and with their a few of their primary consumer products being Chapstick and Robitussin, they did not have much experience with tort law.
For a large number of women, the Dalkon Shield was a more than satisfactory device. Although the device was poorly constructed, painful, and the company fraudulent, many women were still able to use the Dalkon Shield to control
92 Name has been changed to protect the privacy of the claimant. The letter is located on document number 173579, written to the President of A.H. Robins Company, 17 July 1972. The Dalkon Shield Claimants Trust Reel 7, University of Virginia Law Library. 93 Fletcher B. Owen to Mrs. Georgia H. Macomber, 26 April 1972, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library. After the Dalkon Shield Claimants Trust had been established, Robins was more helpful in providing refunds to women. Probably because they were legally required to do so. The reference to the ‘company’ being apologetic is Owen’s implication.
52 their own sexuality and their family’s size. Mary Jane R successfully wore the shield device for over ten years, after a CU-7 and a Lippes Loop expelled from her nulliparous uterus.94 Mary Jane R, and many young women like her, had few non- hormonal birth control options that they could administer, rather than trusting a male sexual partner to wear a condom.
Robins’ officials’ continual support for the Dalkon Shield stemmed from their deep and abiding belief that their IUD was an excellent product. If it had harmed a woman or failed to prevent pregnancy, it must be the fault of the physician or of the
woman herself. AH. Robins’ employees refused to entertain the idea that the shield was a poor IUD. In an internal memo, Moore recognized a high pregnancy rate in
‘certain areas’ and attributed this to physicians “not following the correct insertion protocol and are not checking the patient on follow-up visits.”95 Moore did not question the effectiveness of the shield; he questioned the insertion abilities of the reporting physicians. According to Robins, the pregnancy rate was alarming in that it reflected badly on the doctors, not on the Dalkon Shield as an intrauterine device.
After all, it was difficult to prove conclusively that the Dalkon Shield had introduced bacteria into the uterus, or that the presence of the IUD caused the
bacteria to develop into serious Pelvic Inflammatory Disease (PID). Dr. A.G. Gulliver reported two patient infections to Davis, infections that had been caused by the
94 Mary Jane R (Dalkon Shield user for ten years), in discussion with the author, in Allenton PA, March 2012. Mary Jane R is a pseudonym, given to protect the identity of the interviewee. The Cu-7 and Lippes Loop were also intrauterine devices in the 1970s that Mary Jane R used. 95 Memo from Kenneth E. Moore to several officials and physicians of A.H. Robins, 29 June 1972, “Comments on the Dalkon Shield from Dr. Thad Earl,” Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library.
53 Dalkon Shield.96 When Davis pointed out that the infections may have been caused by something else, Gulliver was easily led into uncertainty. Bacteria were often naturally present in the vagina, or they could be introduced via sexual intercourse.
Connecting those same bacteria to a Dalkon Shield related case of Pelvic
Inflammatory Disease was difficult to prove, and Davis was easily able to create
doubt in the minds of fellow physicians as to whether the intrauterine device should
be blamed for a given infection.
Robins’ executives attributed many of the negative medical reports to
“politics, since the majority of these people are connected with our current or potential IUD competitors.”97 They attributed the Dalkon Shield complaints of IUD experts to personal greed rather than genuine concern. The executives’ denials of
culpability were sincere. They never expected their inter-corporate memos to be
read by the public or exposed in the discovery process, and thus it is clear that their cries of innocence were not a performance.
It was easier for Robin’s employees to believe that Dr. Lippes98 was merely a jealous rival rather than a physician with valid concerns about the safety and efficacy of the Dalkon Shield. Valid complaints and adverse events were being ignored due to the unwillingness of Robins’ executives to acknowledge the dangers innate to their product. The comments of the Population Council were even called
96 R.H. Davis to A.H. Robins Company Medical Department, 27 November 1971. Transcript of conversation between Dr. Gulliver and Dr. Davis, Reel 24, Dalkon Shield Claimants Trust, University of Virginia Law Library. 97 Memo from Kenneth E. Moore to several officials and physicians of A.H. Robins, 29 June 1972, “Comments on the Dalkon Shield from Dr. Thad Earl,” Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library. 98 The inventor of the Lippes Loop, which was an S shaped plastic IUD.
54 ‘slander’ by physicians in the pay of Robins.99 It was harder to attribute adverse events to the failing of the Dalkon Shield.
The loyal employees of the ever-ethical A.H. Robins Company rose to their defense. Robins had provided well for them through the years, paying for trips to
New York City and Cuba. Many of them adored their employer. When the litigation began, employees associated the attacks on the Dalkon Shield as direct attacks on the company that had cared for them so well through the years. The image below
(Figure 5) illustrates the affection employees felt for their bosses at Robins.
99 Ellen J. Preston to Owen, Clark, and Chremos, 24 July 1972, Reel 20, Dalkon Shield Claimants Trust, University of Virginia Law Library.
55
Figure 5, Image courtesy of the Virginia Historical Society
This newspaper photo, or Figure 5, depicts a decidedly sexist image. Women in bathing suits are frolicking with their ‘masculine’ employer. This employer was E.
Claiborne Robins, the chairman of the board of A.H. Robins Company. The two women are holding hands with their married and much older employer, and this action is seen as appropriate. The choice of this image for the newspaper article
56 depicts several things. The first is that young women should be pleased to have a
strong and attentive male protector. His attention is not overtly sexual, but the act of
frolicking through the surf with beautiful women confirms his status as a desirable
member of his community. Women want to be with him, and men want to be him, as
the expression goes. If this photograph is analyzed as a social representation, little
attention was spared for the independence or intelligence of the women shown. All
that mattered was the status of E. Claiborne Robins and his male-dominated
company.
One employee, Jean K. Featherston, wrote to CBS News in order to describe
her positive experiences with the Dalkon Shield and to defend the honor of Robins’
officials.100 Featherston was quite right to voice her opinion on the Dalkon Shield and A.H. Robins Company as she saw fit. However, the officials were not faultless entrepreneurs, as she implied. They had an impeccable public image, which blinded employees and officials to the flaws in their company’s business practices and the resultant substandard shield device.
The FDA had jurisdiction over a medical device that had an intended chemical effect upon a patient’s body. To every batch of shield plastic copper powder and barium sulfate were added. If the FDA had known about the chemicals, or their intended effect, they would have had more control over the production of the Dalkon Shield. However, they were told that the chemicals had nothing to do with the contraceptive efficacy of the shield, and they continued to view the shield as an inert device.
100 Jean K. Featherston to Mr. Mike Wallace of 60 Minutes, 20 April 1981, Reel 18, Dalkon Shield Claimants Trust, University of Virginia Law Library.
57 A corporate memo from Moore reveals that the amounts of barium sulfate would vary depending on what the scientists of Robins thought necessary. 101 In this memo, the amount of barium sulfate added was changed in March of 1973. There was no call for additional testing of the effect this barium sulfate increase would have on the tissue, tolerance rate, or pregnancy rate of the women. Robins executives thought it perfectly appropriate to change chemical composition of the device without testing the, essentially, new IUD they had produced. The device being inserted into most Dalkon Shield users from then on was a nearly untested mix of plastic and metal.
At first, the device salesmen touted the addition of copper metal as an added measure of efficacy. However, the Dalkon Shield that Davis had used had not
contained this metal and Robins could only guess that the addition of copper was
creating an additional measure of protection against pregnancy. 102 Rather than use trial and error, animal trials, or any type of scientific testing, Davis and Robins scientists simply assumed that the addition of copper would produce an improved device, without any deleterious side effects to female users.
Robins’ officials went into a panic. If the FDA began to consider the Dalkon
Shield a drug, the company would need to halt sales and actually wait for research study results, not to mention FDA approval, before they could resume marketing the shield if the device were seen as a drug. They immediately informed Davis to cease
101 Memo from Kenneth E. Moore to Mr. Julian Ross, “Dalkon Shield Formulation Change, 23 March 1973, Reel 7, Dalkon Shield Claimants Trust, University of Virginia Law Library. 102 Hugh J. Davis to George A. Saxton, Jr, 24 March 1971, p. 1, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library.
58 discussing the IUD as containing copper.103 Salesmen were told to halt this tactic
immediately, and downplay the importance of the copper should any physicians
ask.104 Once they stopped advertising the Dalkon Shield’s efficacy as being partially due to the copper content, the FDA no longer had the power to intervene in the device. Only portraying the shield as a drug could place it in the jurisdiction of government intervention. For the brief time that Robin’s used copper content as a sales tactic, they should have been forced to submit their device for approval to the
FDA. The pharmaceutical company’s evasive tactics were effective, and they once again avoided potential government regulation.
The FDA began to think of any IUDs that contained metal as non-inert, and considered demanding they be approved for sale only after extensive testing. This would mean that metal containing intrauterine devices would be treated like a new drug seeking FDA approval. The FDA suspended approval of Searle’s “7” IUD due to the copper content. However, this administration had no intention of halting production of the Dalkon Shield. Robin’s officials had an excellent rapport with the
FDA. The Dalkon Shield, advertised as safe and effective, was beyond reproach and
well liked by employees of the Food and Drug Administration.
103 W. Roy Smith to Dr. Jack Fruend “Dalkon Shield.” 1 April 1971, Reel 24, Dalkon Shield Claimants Trust, University of Virginia Law Library. 104 Edward Hooper to salesmen, 18 June 1971. Document 183118, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library.
59
Mr. David M. Link, Special Assistant to Commissioner Edwards on devices, told me point blank that the theory regarding the copper used to free the mold was fallacious – he is an expert in plastics.
They, the FDA, seem to like our Dalkon Shield, and as long as we make no claims to the copper they do not intend to take any action on our device.105
The FDA did not see the Dalkon Shield as a high priority for device regulation. The copper content would only have been a concern if the salesmen’s claims of additional contraceptive protection provided by copper were brought to their knowledge.
Eventually, Robins could no longer ignore the reports of spontaneous septic abortion. They held a confidential conference on septic spontaneous abortion on
February 15, 1974. 106 After a careful study of the available clinical data,
presentations by leading experts, Dr. Tatum, one of the experts called in, suggested
an emergency program be launched to determine the exact incidence of septic
abortion. Dr. Shulman recommended issuing a warning letter to physicians
regarding the possibility of this condition in their patients. To their credit, A.H.
Robins Company officials decided to follow the advice of these physicians and immediately began communicating sepsis concerns to the medical public. Following the so-called ‘Dear Doctor’ letter, sent May 8, 1974, physicians wrote to the
105 Robert J. Habenicht to A.H. Robins Company Executives including Fruend, Robins, Clark, and Forrest, Reel 24, Dalkon Shield Claimants Trust, University of Virginia Law Library. 106 A.H. Robins Company, Conference on Septic Spontaneous Abortion. 15 February 1974, Reel 21, Dalkon Shield Claimants Trust, University of Virginia Law Library.
60 company to report an additional 40 cases of such septicemia.107 The Dear Doctor
letter detailed proper healthcare steps to protect a patient, should a pregnancy be suspected, and included an incident report of septicemia cases. While Robins refused to acknowledge a definitive causation between the Dalkon Shield and septic abortion, they felt compelled to warn their physicians of a possible correlation.
This wording was an attempt to avoid guilt, while still adhering to the minimum amount of patient protection their conscience dictated. At this point, company officials were still hoping to re-release the Dalkon Shield in an improved
form. If they allowed the Dalkon Shield to be permanently associated with a life threatening condition, sales of the improved device would no doubt suffer. As a result of responses to the Dear Doctor letter, wherein physicians reported even more cases of septicemia, Robins revised their Dalkon Shield labeling to include a sepsis-warning occurrence in October of 1973.108
Robins’ executives refused to take full responsibility for the problem of septic abortions. They claimed that a certain percentage of sepsis could be expected to occur if women or their physicians had induced abortions, and perhaps the infection had nothing to do with the Dalkon Shield.109 Executives were implying the problem was recent legislation that had legalized abortion, rather than a flaw in their device.
They chalked the deaths up to data that would naturally emerge in the years following the legalization of abortion. Rather than attribute the infection rate to the
107 Frederick A. Clark, Preamble of Presentation to Food and Drug Administration, “Statement on Septic Spontaneous Abortion and the Dalkon Shield,” p. 2, Reel 21, 11 June 1974. Dalkon Shield Claimants Trust, University of Virginia Law Library. 108 Ibid. 109 Ibid., 5.
61 intrauterine device, Robins’ officials deflected responsibility onto the controversial
topic of Roe v Wade.
IV. Re-Marketing and the End
Sales of the Dalkon Shield were temporarily halted in June of 1974.110 The
FDA called an expert committee together to determine the safety and efficacy of the
Dalkon Shield. They met, and against the advice of expert council, the FDA declared
the shield device safe for restricted sales on December 20, 1974.111 Dr. Richard P.
Dickey, a member of the Ad Hoc Advisory Committee on Intrauterine Contraceptive
Devices, was alarmed that no recall demands were made on the multifilament
strings that had already been produced and sold.112
The FDA rushed into allowing sales rather than requiring further testing of the Dalkon Shield to establish safety of the device. The convening of an expert committee was a wasteful act if the FDA had no intention of adhering to their recommendations. The Food and Drug Administration would allow the Dalkon
Shield insertions if patients were hand selected and carefully monitored for symptoms of infection. The dangers posed by this particular IUD were not deemed
dire enough to warrant a total recall and destruction of remaining stock. A.H. Robins
110 Newspaper clipping, Chico, California Enterprise Record, 20 December 1974, Reel 8, Dalkon Shield Claimants Trust, University of Virginia Law Library. 111 Ibid. 112 Dr. Richard P. Dickey to Alexander M. Schmidt, 31 December 1974, Reel 25, Dalkon Shield Claimants Trust, University of Virginia Law Library.
62 Company voluntarily planned to switch to a monofilament string when they
released the new version of the Dalkon Shield.113
The public backlash against the FDA ruling was extreme. Some newspapers found the decision to be misogynist. Because a government organization allowed a potentially hazardous intrauterine device back onto the market, women felt that they were being treated like experimental laboratory animals.114 It appeared that government protection was reserved for the pharmaceutical company, A.H. Robins, rather than female consumers. The FDA ruling felt like another betrayal and another
example of men protecting men.
Women felt that even their bodies were without ally in Equal Rights
Amendment era United States. These public opinions forced the FDA to issue a directive to halt sales of the Dalkon Shield. A.H. Robins’ executives hesitantly agreed to this directive in June of 1974.115 Even at this point, Robin’s officials remained
confident that the Dalkon Shield was as safe as any other intrauterine device on the
market. The FDA request for a halt of sales felt like unnecessary action to the pharmaceutical company. However, for the wearers of the Dalkon Shield, the directive felt like too little help from the government, far too late.
Davis was never able to acknowledge that he had benefitted financially from the results of his research. When questioned by lawyers during a deposition, Davis
113 Staff reporter, Wall Street Journal, “A.H. Robins to Collect Unused IUDs in the U.S., Slates Modification,” 21 Jan 1975. 114 Trudy Morrison, Beacon News, “Women are Used as Laboratory Animals.” 5 February 1975, Aurora, IL. 115 A.H. Robins Company, “A.H. Robins to Comply with FDA Ruling on Dalkon Shield, but Feels Action Not Warranted by Present Evidence,” June 1974, Reel 23, Dalkon Shield Claimants Trust, University of Virginia Law Library.
63 denied having received any type of financial reimbursement from the Dalkon
Corporation, Lerner Laboratory, or A.H. Robins in the form of royalty payments or stock ownership in relation to the Dalkon Shield. His reasons for supposed payment refusals were, ironically, based on ethics.
Because I did not feel I should be in a position of testing and evaluating a device 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.116
Davis had perjured himself, against the advice of his lawyers. The paperwork
revealed in the discovery process indicated that Davis had profited from his
research, and if he had been worried that his scientific integrity would appear impugned by this financial gain, then he was correct. His word as a physician became meaningless. At a different deposition, Davis revealed that Lerner had given him a 30 percent interest in any royalties the Dalkon Shield generated for the
Dalkon Corporation.117
Davis perjured himself repeatedly in several of his depositions. At one, he claimed that he had not begun testing on ‘Lerner’s’ Dalkon Shield until 1968, but he was already writing scientific articles about his results as early as February of
1966.118 Davis was trying to keep the truth of his role in the Dalkon Shield
development a secret. However, the paper trail being revealed in the legal discovery
116 Deposition of Dr. Hugh J. Davis, 20 February 1974, p. 29, Reel 11, Dalkon Shield Claimants Trust, University of Virginia Law Library. 117 Deposition of Hugh J. Davis, 13 January 1975, p. 1852, Reel 26, Dalkon Shield Claimants Trust, University of Virginia Law Library. 118 Memorandum to file, 9 June 1970, “Notes on visit to Dr. Hugh Davis, Baltimore on 6/8/70,” Reel 22, Dalkon Shield Claimants Trust, University of Virginia Law Library.
64 process showed the many holes in his and Lerner’s story. Mother Jones Magazine
revealed to the public that Davis had made a hefty profit off of the Dalkon Shield. In
total, he made $712,500. 119 The co-owners of the Dalkon Corporation and A.H.
Robins Company also did quite well from device sales.
Figure 6, Image courtesy of The Dalkon Shield Claimants Trust
It is the sad truth that Davis was not in an appropriate mental state to design, test, and calculate efficacy results for medical devices. In 1974, Robins’ officials became aware that Davis had a medical condition that rendered him into states of
119 Mark Dowie, Mother Jones Magazine, November 1976, p. 48, Reel 13, Dalkon Shield Claimants Trust, University of Virginia Law Library.
65 paranoia.120 Although, no official medical diagnosis was ever rendered to Davis (at least not publicly) it was clear he had reached extreme levels of paranoia.121 This would explain the deterioration of Davis’ professional relationship with A.H. Robins
Company. He became unreliable and tended to towards paranoia; the paranoia extended into thinking that people were after him, such as employees of other pharmaceutical companies. Robins’ employees had no way of knowing that Davis was paranoid at the time of the Dalkon Shield purchase, but Davis was a stranger to them. A medical degree should not have made Davis exempt from scrutiny. Any individual, and their research, should have been intensely examined by Robins’ scientists prior to purchasing an experimental medical device.
The owners of A.H. Robins Company had trouble accepting the end of the
Dalkon Shield. They spent considerable time exploring new strings, insertion methods, and new marketing tactics. However, it became clear that public opinion had turned against the device. The Dalkon Shield name had been so vilified that new components could not re-popularize the device. The ‘Meeting for the Remarketing the Dalkon Shield’ was set for January 30, 1975.122 It was cancelled on January 29th, and no plans were made to reschedule. The Dalkon Shield would not be re-released
120 Deposition of a Robin’s official, Date Unknown, Vol IV – 77, Reel 42, Dalkon Shield Claimants Trust, University of Virginia Law Library. 121 At certain points in Davis’ life, he believed there were plots against his life. He wanted bodyguards to protect him and his family. These perceived threats were never substantiated. 122 Memo from Allen J. Polon to Robin’s executives and medical staff, 29 January 1975, Reel 7, The Dalkon Shield Claimants Trust, University of Virginia Law Library.
66 by Robins. The company made the official announcement on August 8, 1975.123 This decision was made not on the basis of public safety, but rather the only thing that could make a pharmaceutical company admit defeat of a favored product: unfavorable predictions for re-marketing the intrauterine device. Abysmal financial prospects were what finally killed the Dalkon Shield.
Investigative reporters were able to raise pubic awareness of the Dalkon
Shield flaws in an unprecedented manner. Serial reporting involved individual journalists publishing a series of articles on the same topic. Morton Mintz was able to publish shocking developments each week in the Washington Post.124
The next several decades would be spent in a painful battle between women
harmed by the shield and the A.H. Robins Company. A class action lawsuit was
brought against the company, and after years a settlement was reached. The Dalkon
Shield Claimants Trust then spent several years divvying up the money to users of
the shield. Unfortunately for many women suffering from infertility, the money
came too late to procure expensive fertility treatments such as IVF. Without children,
or apology from the men of Robins, the trust of countless women had been broken
and their lives forever changed.125
123 Roscoe E. Puckett, Manager of Public Information at A.H. Robins, “News.” 8 August 1975, Reel 23, Dalkon Shield Claimants Trust, University of Virginia Law Library. 124 Morton Mintz (investigative journalist), in discussion with the author, Washington D.C., July 2011. 125 Meryl Gordon, “A Cash Settlement, but No Apology.” The New York Times, February 1999.
67 V. Conclusion and the Black Death of the Dalkon Shield
A bizarre aspect of this saga has yet to be told. Some shields had turned black
while in utero. The IUDs had changed from a sterile looking white plastic to a
foreboding black color, a discovery that was not made until removals began. This
alteration baffled physicians, and their perplexity was deepened because only a
small number of devices underwent the change. However, the ever-changing
chemical content of the devices can account for the lack of consistency. Perhaps the
copper content accounted for the black coloration, and some vats of plastic simply
had a higher metal content than other batches. Either way, this small mystery is
representative of the whole fiasco. It exemplifies the lack of understanding for the
Dalkon Shield device, the inferior product standards, and the overall frightening
connotation of the IUD. The inexplicable chemical change is symbolic of this deadly
and dark chapter in contraceptive history.
A considerable social distance existed between Dalkon Shield female users
and the executives of A.H. Robins Company. Repeatedly, those that had social power
ignored the voices of those with less status. Women wrote to the company with
concerns about the safety and efficacy of the device. Women told their physician’s of
the excruciating pain the device brought their bodies. Yet, their apprehension was
ignored. Their concerns were not as important as the opinions of men with
education and wealth.
There were many social aspects of this story that cannot be fully covered in a master’s thesis. For instance, religion likely played a role in the inability of Robins’
68 officials to take responsibility for their actions. Paid employees of the company,
from the chairman down, would have perceived the company as it presented itself:
as a Baptist-based and well-intentioned group of individuals. They may not have
seen beyond this and recognized that the main goal of any company was to turn a profit. Innate greed would always influence the decision making process at A.H.
Robins Company. The religious base of the corporation may have provided Robins’ executives with a way to rationalize their poor behavior. Their thinking may have been that as wholesome individuals, they could not possibly commit harmful acts upon the bodies of their fellow humankind.
Government legislators in Congress and members of the FDA did not recognize that inert, non-chemical devices could hurt consumers. If they had taken a harder look at the Dalkon Shield they would have seen its shoddy construction. A simple analysis of Davis’ study would have revealed fraud. Members of the
American public assumed that if the FDA was unconcerned about inert medical devices, then its safety could be assumed. The government assumed the efficacy of the plastic Dalkon Shield, so women did as well. This FDA error betrayed the trust of female consumers.
Greed cannot tell the whole of the Dalkon Shield story. It can, however, shed considerable light on the actions of the owners of the Dalkon Corporation and
Robins’ company officials. The Dalkon Shield had been appealing to a previously untouched group within the birth control market. Women who had never carried a child (noun: ‘nullips’) had trouble retaining other available intrauterine devices.
IUDs such as the Lippes Loop were often expelled from their smaller uteri. The
69 Dalkon Shield’s side fins would prevent expulsion. Robins saw the money making
potential of these side fins. Moreover, there was potential for this to be a mere
beginning to their birth control line of products. The Dalkon Shield could also
provide them income in their form of Dalkon Foam, a spermicide. They rushed to
bring this device to market, fearing government intervention, and were blinded to
the shield’s deficiencies by the dollar signs in their eyes.
A.H. Robins had not intended to kill 17 of their customers. But, their
inexcusable lack of knowledge about intrauterine devices and repeated acts of fraud
led to that tragic result. Ignorant of the birth control market, they trusted Dr. Hugh J.
Davis and his research implicitly. However, once they bought the device, they
employed questionable sales methods and failed to offer appropriate pain
management plans for patients. The government, too, failed the public by lacking
any consumer protection legislation for ‘inert’ medical devices.
A.H. Robins Company was not a corporation of extraordinarily evil men, but
their inaction and duplicitous ways casts both them and their corporation into the
infamous annals of history. At least 17 women in the United States alone were killed
of Dalkon Shield related complications, and thousands more were rendered infertile
or chronically ill.126 The most dismaying aspect of this story is that a small amount of caution and care on the part of a few men could have prevented the sad fate of many vibrant young women.
126 By Robin’s own estimate, 4% of Dalkon Shield users were injured from device related complications. Mintz, 7.
70 Appendix
I attempted to explore every archival resource available to me, but there were financial and time limitations. Harvard University has a large number of litigation papers that prove to be useful research material. Unfortunately, I was not able to delve into this resource. This collection might contain additional corporate documents.
71 Research Locations and Collections
Food and Drug Administration, Biosciences Library, Maryland
The National Archives at College Park, Maryland
The National Library of Medicine, Maryland
Dalkon Shield Claimants Trust, University of Virginia Law Library
A.H. Robins Company Records, Virginia Historical Society, Virginia
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