The Depth Charge in the Womb
An Essay on the Dalkon Shield
Four days before A. H. Robins signed the contract to purchase the Dalkon Shield intrauterine device, the company’s own director of pharmaceutical research reported that no one knew how long the device’s tail string would remain chemically stable inside a woman’s body. “The device has not been subjected to any formal stability testing,” Oscar Klioze wrote in his memo on June 8, 1970. He also noted that the plastic used in the Shield had been cleared by the FDA for packaging meat — not for implantation in humans.
Seventeen days after the purchase, on June 29, a company orientation report circulated to thirty-nine executives — including the chairman, the president, and multiple vice-presidents — carried a more specific warning: the tail string had a “wicking” tendency, meaning it could draw bacteria from the vagina into the sterile uterus. The report recommended “a careful review.”
A. H. Robins began selling the Dalkon Shield nationally six months later. It never conducted wicking studies on the string. Over the next four years, the company distributed 4.5 million Shields in eighty countries. By the company’s own conservative estimate, roughly 88,000 women in the United States alone were injured. At least eighteen died. Hundreds of thousands suffered pelvic infections, septic abortions, perforated uteri, and permanent sterility.
The Dalkon Shield is sometimes treated as a historical curiosity — a cautionary tale from an era of looser regulation. That framing obscures what actually happened. The record, built from internal company memos, sworn depositions, congressional testimony, and court documents, reveals something more instructive: a template. A sequence of decisions, repeated across every phase of the product’s life, that follows a pattern so consistent it functions as a blueprint.
That pattern is worth studying in detail. Not because the Dalkon Shield is unique, but because it is not.
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The Founding Fraud
The Dalkon Shield’s commercial life rested on a single published study. In February 1970, Dr. Hugh J. Davis of Johns Hopkins University reported in the American Journal of Obstetrics and Gynecology that, of 640 women fitted with the Shield over twelve months, only five became pregnant — a rate of 1.1 percent. This made the Shield competitive with oral contraceptives and dramatically superior to every other IUD on the market.
The study had foundational problems that A. H. Robins knew about before it bought the device.
The average duration of use per patient was 5.54 months — barely half the twelve-month study period. Biostatistical researchers at Johns Hopkins estimated that a minimum of 1,200 patients would have been needed to establish a pregnancy rate of one or two percent with confidence. Davis used 640. He sent his data to the university’s statisticians within three days of the study’s closing date — far too quickly to capture pregnancies that had occurred but not yet been detected. When participants dropped out of the study, they vanished from the data, and these were the women most likely to have become pregnant or experienced complications. Davis testified vaguely that “less than 5 percent” were lost to follow-up. If one or two of them had conceived, the 1.1 percent rate would have dissolved.
Davis had a financial stake in the outcome. He held 35 percent of the Dalkon Corporation, the entity that sold the Shield to A. H. Robins for $750,000 plus a 10 percent royalty. He was also retained as a paid consultant. None of this was disclosed in his published study. When asked at a Senate hearing whether he had “recently patented such a device,” Davis gave testimony that was technically accurate and deliberately misleading: “I hold no recent patent on any intrauterine device.” He held something more valuable — equity.
A. H. Robins knew the published figures were wrong before finalizing the purchase. When Dr. Fred Clark visited Davis in Baltimore on June 8, 1970, to review the data, he found that over fourteen months, 832 insertions had produced 26 pregnancies — a rate of 3.1 percent, nearly three times what Davis had published. Clark recorded these numbers in a confidential memo that circulated to senior officials. A. H. Robins later claimed the discrepancy resulted from Clark’s secretary misreading his handwriting.
That explanation sits uneasily beside a second memo, written three days later by senior vice-president Jack Freund, which stated that Davis’s one-year follow-up period was not long enough “to project [pregnancy figures] with confidence to the population as a whole.” The company’s own biostatistician, Lester Preston, was never asked to review the fourteen-month data.
A. H. Robins purchased 199,000 reprints of the Davis article and distributed them to physicians. By August 1973, the company had printed more than five million pieces of Shield promotional literature. The 1.1 percent pregnancy rate remained the centerpiece. An internal memo from Shield project coordinator Allen Polon, dated October 31, 1973, finally stated what the company had long known: “A pregnancy rate of 1.1 percent is stated which is not valid.” Polon recommended destroying the literature. By then, A. H. Robins had captured 56 to 59 percent of the American IUD market.
The promotion machine extended beyond reprints. In September 1972, Robins published “A Progress Report,” reportedly the largest and costliest advertisement in the history of the IUD business — an eight-page, multicolor spread proclaiming “The IUD That’s Changing Current Thinking About Contraceptives.” It cited four published studies to substantiate low pregnancy rates. The highest rate cited was four times the lowest, a statistical oddity the ad did not address. Two of the four studies were authored by men with undisclosed financial ties to the company: Davis, and Dr. Thad Earl, a Defiance, Ohio physician who held 7.5 percent of the Dalkon Corporation stock and received royalties on every Shield sold. Earl reported a 0.5 percent pregnancy rate — a figure that matched a prediction Davis had made at an international conference months before Earl’s study was completed. A. H. Robins helped Earl draft his article and performed the statistical calculations. Neither Earl’s financial stake nor his consultancy was disclosed in the publication.
A company telegram to its northern sales division captured the ethos: “Northern Division will not be humiliated by a lack of Dalkon sales. If you have not sold at least 25 packages of 8 then you are instructed to call me. Be prepared to give me your callback figures. No excuses or hedging will be tolerated, or look for another occupation.”
Independent studies told a different story. The Kaiser-Permanente Medical Center in Sacramento reported a 5.6 percent pregnancy rate and a 28.7 percent removal rate. Beth Israel Hospital in Boston reported 10.1 percent. Dr. William Floyd of Wayne State University reviewed the Davis study’s internal evidence, concluded it was biased, and suggested the true rate was around 5 percent. A. H. Robins ignored him. In July 1973, the FDA wrote directly to Chairman E. Claiborne Robins asking him to reconcile the very low pregnancy rates in the company’s advertisements with the much higher rates reported by independent researchers. Robins testified that he had received the letter but could not recall it.
The String
The tail string is where the story becomes a matter of life and death.
Every IUD has a string that runs from the device inside the uterus, through the cervix, into the vagina. It allows the woman to check the device’s position and the doctor to remove it. The string passes through the cervical canal, where mucus acts as the body’s barrier against bacterial invasion. On every other IUD of that era, the string was an impervious monofilament — bacteria could not get into it.
The Dalkon Shield string was different. To the naked eye, it appeared to be a monofilament. Under magnification, it was a cylindrical sheath encasing 200 to 450 separate round filaments, separated by spaces. Neither end was sealed. Any bacteria that entered the spaces between the filaments would be insulated from the body’s immune defenses while being drawn upward into the uterus by capillary action — the same phenomenon that draws melting wax up a candle wick.
Irwin Lerner, the Shield’s listed inventor, warned A. H. Robins about the wicking tendency on or before June 29, 1970. This warning reached thirty-nine executives. No one acted on it.
Wayne Crowder discovered the danger independently. Crowder was a quality control supervisor at Chap Stick Company, a Robins subsidiary in Lynchburg, Virginia, assigned to oversee Shield production when assembly moved there in 1971. In March of that year — less than two weeks after he first learned of the Shield’s existence — Crowder noticed tiny holes in the string’s sheath below the attachment knot, caused by the tying process. He rejected an entire shipment of 10,000 to 12,000 Shields. His superiors at Chap Stick asked A. H. Robins for permission to override the rejection. Permission was granted. The Shields were shipped.
Crowder conducted his own wicking experiment. He stood clipped sections of the string in beakers of water. Hours later, he could squeeze water from the dry ends. The strings wicked through the knots. He demonstrated the results to his supervisor, Julian Ross. Ross told him the string was not his responsibility and to leave it alone.
Crowder then demonstrated a solution. He applied the flame of a cigarette lighter to the open end of a string and watched it shrivel into a small, solid bead. Heat-sealing. Simple, effective, and cheap. He showed this to Ross, then to Chap Stick president Daniel French. French acknowledged the logic, called Crowder’s concern about infection “reasonable,” and predicted that “Robins wouldn’t go for” the fix. “He said that they had too much time and money invested in the present configuration,” Crowder testified. French estimated the cost of heat-sealing at five to ten cents per Shield. A. H. Robins sold each Shield for up to $4.35.
Crowder tried to escalate. French passed the concern to A. H. Robins. Dr. Fred Clark called French and sharply rebuffed him for worrying about testing. Chap Stick should focus on getting the device assembled and packaged. French backed down. “It is not the intention of the Chap Stick Company to attempt any unauthorized improvements in the Dalkon Shield,” French wrote. “My only interest in the Dalkon Shield is to produce it at the lowest possible price and, therefore, increase Robins’ gross profit level.”
Ross told Crowder he hoped he had finally gotten the string business out of his system. “I told him that I couldn’t in good conscience not say something about something that I felt could cause infections,” Crowder later testified. “And he said that my conscience didn’t pay my salary.”
A. H. Robins did not attempt to duplicate Crowder’s wicking studies until 1974, after the Shield was already off the market. The heat-sealing idea was revived around the same time — and then dismissed. “It is too late to ‘heat seal’ now,” wrote Ellen Preston in a December 1974 memo. “We need to abandon the ‘multifilament’ string. Heat-sealing would have been a good thing to have done 4 years ago.”
Meanwhile, Kenneth Moore, the Shield project coordinator, spent three years “desperately searching,” as he later put it, for a new tail string. Company officials swore under oath that the search was unrelated to any concern about bacteria or infection. “There was no safety reason behind my search,” testified microbiological research director Robert Tankersley. The company found a superior alternative — Gore-Tex, which would not wick, was soft, strong, and nearly indestructible. The estimated cost was 6.1 cents per string, compared with 0.63 cents for the existing Supramid string. For one million Shields, the difference was approximately $54,000. Robins’s average net earnings at the time were nearly $70,000 per day.
The company chose not to switch.
In January 1975, Tankersley outlined four experiments to determine whether the string wicked bacteria. He estimated they would take two and a half weeks, use four rabbits, and cost $90. The experiments were not funded.
Wayne Crowder was forced out of Chap Stick during a company reorganization in 1978. He had worked there for fifteen years and was earning $13,500 a year. He filed a wrongful termination suit, but a judge ruled he had missed the one-year statute of limitations. As of 1985, he had been unable to find regular employment. “No exceptional genius was required to understand the hazards of that design,” he said.
The Bodies
On March 30, 1973, a thirty-one-year-old Arizona mother of two died after her uterus spontaneously aborted the baby she had been carrying for more than four months. The infection had spread rapidly, essentially poisoning her. Antibiotics could not save her. She had become pregnant while wearing a Dalkon Shield.
Spontaneous septic abortions in the middle trimester of pregnancy were extremely rare in 1973. Until then, the only septic abortions doctors encountered were in women who had undergone illegal or self-induced procedures. This woman had not tried to abort. Her Shield was still in place when the infection took hold.
A. H. Robins learned of the death two months later through the medical grapevine. Dr. Donald Christian, head of obstetrics and gynecology at the University of Arizona Medical Center, was struck by the case. He later learned of two additional deaths — including a twenty-four-year-old mother of two who developed flu-like symptoms during her fourth month of pregnancy. Three days later, she was dead.
Christian contacted A. H. Robins, the FDA, and the Centers for Disease Control. He says the agencies ignored him. The company’s response, through Ellen Preston, was to treat the reports as isolated incidents. “I would estimate that I have been advised of a dozen, at the very most, cases of septic abortion associated with the Dalkon Shield,” Preston wrote. The company’s own complaint file, withheld from FDA inspectors until congressional pressure forced its release, indicated an 8.8 percent pregnancy rate — eight times the advertised figure.
By June 1974, Christian’s paper linking the Shield to fatal sepsis appeared in the American Journal of Obstetrics and Gynecology — the same journal that had published Davis’s original study four years earlier. “The greatest concern is the rather insidious yet rapid manner in which these patients become ill,” Christian wrote. In three of the five deaths he documented, the first symptoms — disarmingly innocuous in themselves — occurred within thirty-one to seventy-two hours of death.
The toll mounted. By August 1974, the FDA had reports of eleven deaths and 209 serious illnesses from septic abortions in Shield wearers. The Centers for Disease Control surveyed 34,544 physicians and found that fatal septic abortions occurred twice as frequently among Shield users as among women wearing other IUDs. The Planned Parenthood Federation instructed its 183 clinics to stop prescribing the Shield.
A. H. Robins did not recall the device. It suspended marketing on June 28, 1974, after FDA Commissioner Alexander Schmidt requested a halt until the Shield’s “questionable safety” could be reviewed. But company chairman E. Claiborne Robins, Sr., privately celebrated that the FDA had not demanded a full recall. “We had all felt that the decision would be political,” he wrote in an internal memo. The FDA’s press release announcing the suspension — which company officials had helped draft — “helped reinforce our image as an ethical pharmaceutical company.”
The company continued to insist the Shield was safe and effective. It formally abandoned plans to remarket the device in August 1975, but took no action to remove the estimated 600,000 Shields still inside American women. That recommendation did not come until September 1980, when a “Dear Doctor” letter suggested removal. The October 1984 recall — the company’s first direct communication to women themselves — came more than a decade after the deaths began.
In the meantime, Dr. Howard Tatum, inventor of the rival Copper-T IUD, had independently confirmed what Crowder and Lerner had warned about years earlier. Tatum suspended Shield tail strings in dye solution. Within twenty-four hours, dye rose through the entire length, past both knots. He repeated the experiment with live E. coli bacteria. After forty-eight hours, bacteria had risen to the base of the final knot — which would sit inside the uterus. He found no wicking in any other IUD. Tatum then examined used Shield strings returned from clinics across the country and successfully cultured bacteria from their interiors. He found breaks in the nylon sheath, especially just below the attachment knot — exactly where Crowder had found them.
The string’s nylon 6 sheath deteriorated inside the body, as the medical literature since 1956 had warned nylon would do in body cavities. Professor Paula Fives-Taylor of the University of Vermont found that the number of bacteria adhering to strings increased 40 percent after twenty-five to thirty-six months of use — and tripled after thirty-seven to forty-eight months. A woman wearing a Shield for thirty-six months was 9.2 times more likely to suffer pelvic inflammatory disease than a woman using no contraception. For other IUDs, the risk was 1.2 times greater.
The Dalkon Corporation had recommended replacement of the Shield after two years — a recommendation that could have averted infections in countless women. A. H. Robins dropped this guidance because its leading competitor’s labeling made no such recommendation.
The Regulatory Void
The Dalkon Shield entered the market through a gap in federal law that seems almost designed for exploitation. In 1970, the FDA regulated drugs but not medical devices. An IUD was classified as a device. This meant that A. H. Robins was not required to demonstrate safety, conduct clinical trials, submit data to the FDA, or secure approval before selling the Shield to millions of women.
Hugh Davis had exploited this gap from the start. On January 14, 1970 — eight days before his study appeared in print — he testified as the lead witness before Senator Gaylord Nelson’s subcommittee hearing on birth-control drugs. Before television cameras and a press corps covering a guaranteed story, Davis built the market for his own undisclosed product by stoking fears about the Pill. “Shall we have millions of Americans on the pill for twenty years and then discover it was all a great mistake?” he asked. Within minutes, he pushed the Shield’s purported efficacy ever closer to perfection: “some modern intrauterine devices provide a 99 percent protection against pregnancy... The intrauterine devices that are available now can give you a 99 percent or better protection.” Viewers assumed they were watching a scientist from a distinguished academic institution motivated by concern for women’s health. They were watching a 35-percent shareholder.
A. H. Robins understood the value of the device classification and worked to protect it. The Shield contained copper sulfate, which the company initially believed might have a contraceptive effect — which would have made the device a drug, triggering FDA oversight and testing requirements. Internal discussions established that the copper served no purpose. “Does copper in Shield accomplish anything? No!” was the consensus at a February 1972 meeting of five Robins doctors and scientists. But the company continued marketing the copper-containing Shield rather than reformulating it, because the copper’s ineffectiveness was precisely what kept the device out of the FDA’s drug-regulation framework. When the FDA asked, Robins supplied data supporting the conclusion that the copper was pharmacologically insignificant. The FDA agreed: the Shield was a device.
The Medical Device Amendments — which would have required demonstration of safety and efficacy before marketing — did not become law until May 1976, six years after the Shield entered the market and two years after it was pulled.
The regulatory void extended beyond classification. The FDA had no authority to require adverse event reporting for devices, no power to compel recalls, and no systematic mechanism for collecting safety data. When reports of deaths and infections accumulated, the FDA could request information, hold hearings, and ask the company to stop selling. It could not order any of these things. Every consequential action depended on A. H. Robins’s voluntary cooperation.
At the 1973 congressional hearings, Dr. Russel Thomsen — an army obstetrician-gynecologist who had been publicly criticizing the Shield — dissected the company’s advertising claims with systematic precision. He demonstrated how the “life table” statistical method, originally developed as a legitimate research tool, had been co-opted for advertising. He showed that the four studies cited in the “Progress Report” covered averages of only 5 to 6 months of use, projected outward to create the appearance of twelve-month data. He walked the committee through Davis’s textbook, which featured a chart comparing ten IUDs in which the Dalkon Shield — modestly listed last — was superior in every category. The chart compared the Shield’s short, inadequate study against much larger and longer studies of its competitors. “The deception is amazing,” Thomsen said. Representative Clarence Brown asked if Davis was “party to fraud.” Thomsen paused. “Yes, I do after going from the beginning to the end of this.”
Thomsen characterized the “Progress Report” as “a calculated effort to mislead the doctors.” The FDA’s director of medical devices dismissed the ad’s problems as “mild puffery.”
The Suppression
The company’s behavior during litigation added a dimension that the founding fraud and the regulatory gap cannot fully explain.
A. H. Robins hired the law firm McGuire, Woods, and Battle to handle Shield lawsuits in mid-1975. The firm commissioned its own studies on the tail string. These became known as the “secret studies” because their results were never made public. Whenever a judge ordered their production, the company offered settlements that plaintiff attorneys found impossible to refuse.
The concealment extended to regulatory proceedings. In April 1975, Dr. Fred Clark appeared before the FDA’s Ad Hoc Committee and was asked whether private studies had been conducted on the Shield. The answer was no. In fact, eight months after national marketing began, Robins had initiated a two-year safety study in baboons. It produced a 30 percent perforation and migration rate and killed one animal in eight from perforation or infection. This information was available when Clark testified. It was not brought to the committee’s attention.
Roger Tuttle, a Robins attorney from 1971 to 1976 who later taught law at Oral Roberts University, revealed during a 1984 deposition that Dalkon Shield documents had been destroyed. The destruction had taken place in early February 1975, while a jury was deliberating in one of the first Shield trials. Tuttle said he had been prompted to come forward by Judge Miles Lord’s speech to Robins executives the previous month.
Judge Lord, a U.S. District Judge in Minneapolis assigned twenty-three Shield cases in December 1983, had personally traveled to Richmond to supervise document production after months of obstruction. He found depositions conducted in cramped, overheated rooms at the company’s own headquarters, with defense attorneys sitting shoulder-to-shoulder with their clients — positioned so that “a nudge by an attorney could, and did, silence the deponent.” The company rotated its legal team so frequently that “the court must start up from ground level over and over.” When Lord examined the discovery record, he concluded that documents relevant to the Shield had been withheld during years of prior litigation.
On February 29, 1984, Lord delivered a statement to three senior Robins officers summoned to his courtroom. He had originally intended to have them read it silently, but after their attorneys instructed them not to respond to his questions, he read it aloud:
“When the time came for these women to make their claims against your company, you attacked their characters. You inquired into their sexual practices and into the identity of their sex partners. You exposed these women — and ruined families and reputations and careers — in order to intimidate those who would raise their voices against you.”
A. H. Robins filed two complaints against Lord for judicial misconduct. The company retained former U.S. Attorney General Griffin Bell to lead the counterattack. Lord was cleared of misconduct, but his speech was expunged from the record. His legal bills totaled $110,000.
The company’s courtroom strategy against plaintiffs was systematic. In the case of Linda Harre of Tampa, Florida, who had suffered pelvic inflammatory disease and was left unable to bear children, Robins’s sole expert witness on wicking was Dr. Louis Keith, a paid consultant who had received $277,092 from the company by April 1985. Keith testified that his own laboratory experiments showed the string did not wick bacteria, and the jury believed him. An FBI investigation of possible perjury followed. Harre lost her case.
Even A. H. Robins’s own general counsel, William Forrest, was not spared the Shield’s consequences. In a 1984 deposition, Forrest disclosed that his wife had undergone a hysterectomy shortly after her own Shield was removed in 1975. Asked whether her doctor had indicated any connection to the device, Forrest replied: “Not that I know of.” Had he asked her? “I don’t recall.” He was promoted to vice-president.
Overseas
While the company fought to contain the crisis domestically, the Shield’s reach extended far beyond American borders.
The Agency for International Development began shipping Shields to developing countries in April 1971, initially at the request of the International Planned Parenthood Federation. By mid-1974, AID had distributed nearly 700,000 Shields to approximately seventy countries. The relationship between Robins and AID was close; as AID’s own later report noted, “Especially close was the working relationship developed by Robert W. Nickless, Director of International Marketing for A. H. Robins, with A.I.D.”
After Robins suspended domestic marketing in June 1974, AID issued warnings to its field offices — but did not recommend that Shields already inside women be removed. This was, as AID later explained, “in line with FDA and manufacturer pronouncements on the subject.” The recommendation for removal did not come until September 1980, six years after the suspension of sales. By then, the damage had long been compounding inside women across the developing world.
AID later accounted for 47 percent of the Shields it had distributed — 328,997 devices returned or destroyed. The remaining 53 percent — 368,295 Shields — were unaccounted for. AID’s report concluded that “few Dalkon Shields are likely still in use.”
Attorney Martina Langley, who spent years working with the poor in Central American clinics, called this conclusion “a hypocritical joke.” She had seen Shields being inserted in women as late as 1980 in El Salvador. Record-keeping in the country’s medical clinics was, in her words, “atrocious, if it exists at all.” There was no way to know how many Shields had been inserted or removed. Neither A. H. Robins nor AID conducted publicity campaigns to inform women in developing countries about the danger. Robins operated a plant in San Salvador. “If they would give five cents apiece for Shields, they would have gotten every one of them,” Langley said.
Inexpensive radio campaigns would probably have been adequate to reach most of these women. Langley’s requests to A. H. Robins to fund such campaigns went unanswered. In Australia, an estimated 100,000 Shields were sold, with no way to verify how many had been inserted. Across seventy-nine countries, the recall effort depended on cables to field offices and letters to ambassadors — not on any direct communication with the women who were actually wearing the device.
The Reckoning That Wasn’t
A. H. Robins filed for bankruptcy in August 1985. Through June of that year, 14,330 lawsuits had been filed, with new claims arriving at fifteen per day. The company and its insurer had paid out $378.3 million to dispose of cases, plus $107.3 million in legal expenses. Juries awarded $24.8 million in punitive damages. The company established a $615 million reserve fund, generating $126 million in tax benefits — meaning American taxpayers subsidized a portion of the cost of compensating the company’s victims.
No A. H. Robins executive faced criminal prosecution. Most of the officials who played key roles in the Shield’s history were promoted. E. Claiborne Robins, Sr., remained chairman of the board. The company continued to insist that the Shield was safe and effective, “no worse and perhaps better in design than other IUDs still on the market.” The Shield had simply been the victim of a biased press and greedy plaintiffs’ attorneys, according to former president William Zimmer and other officials.
Some victims who stood to win substantial damages chose not to sue — either because they wanted to put a horrifying experience behind them, or because they valued avoiding public disclosure of a matter as private as the destruction of their ability to bear children. Others were deterred by the company’s courtroom strategy, which included invasive interrogation of women’s sexual histories and the exposure of their private lives — calculated, as Judge Lord charged, “in order to intimidate those who would raise their voices against you.” Still others did not know or had forgotten the make of their IUD. By January 1985, nearly 4,000 calls had come in on the company’s phone lines from women wearing an IUD “of unknown type.”
The family remained prominent philanthropists in Richmond, Virginia, where, as one newspaper reported, “there is scant talk about the cloud that hangs over Robins.”
The company’s position, maintained through fourteen years of litigation, never shifted: “Robins believes that serious scientific questions exist about whether the Dalkon Shield poses a significantly different risk of infection than other IUDs.”
The Template
The Dalkon Shield story follows a sequence that has repeated across industries and decades. Each element of the sequence is documented here not by inference or speculation, but by the company’s own internal memos, sworn testimony of its own officers, and the rulings of federal judges who reviewed the evidence.
The sequence:
A founding study with fatal methodological flaws, authored by a researcher with an undisclosed financial stake, published in a prestigious journal and distributed to hundreds of thousands of physicians as though it were independent science.
A known defect — identified before national marketing began, confirmed by a quality control supervisor within weeks of encountering the product, fixable for pennies — suppressed because addressing it would slow production, increase costs, and implicitly acknowledge a problem.
A regulatory void, understood and actively maintained by the company, that allowed a device implanted in millions of women to reach the market without a single required safety test.
Warnings from inside and outside the company — from its own quality control supervisor, from independent physicians, from a congressional witness — met not with investigation but with dismissal, retaliation, and bureaucratic absorption.
A body count that accumulated for years while the company treated each death as an isolated incident, challenged the methodology of every unfavorable study, and funded its own research to generate favorable data.
A delayed recall, driven not by concern for women’s safety but by the calculus of litigation — delayed explicitly because, as the company’s own attorney argued, a recall would be “a confession of liability.”
Legal warfare against victims, including invasive interrogation of their sexual histories, calculated to deter future plaintiffs from coming forward.
Document destruction during active litigation. Secret studies whose results were suppressed by settling cases before judges could compel their disclosure.
And throughout, the promotion and retention of every executive involved, the absence of criminal accountability, and the company’s unwavering public insistence that nothing was wrong.
Wayne Crowder sealed the end of a string with a cigarette lighter in March 1971 and showed his bosses how to prevent infections. The fix would have cost pennies. He was told his conscience didn’t pay his salary, and eventually he was pushed out. Fourteen years later, he couldn’t find work.
The women — in Baltimore, in Tucson, in Defiance, Ohio, in El Salvador — were never asked whether they’d like to participate in this experiment. The document exists. The signatures are on it. The dates precede the marketing. Whatever word you choose for the distance between what was known and what was done, the record is not ambiguous about what it contains.
References
Morton Mintz, At Any Cost: Corporate Greed, Women, and the Dalkon Shield (New York: Pantheon Books, 1985).
Susan Perry and Jim Dawson, Nightmare: Women and the Dalkon Shield (New York: Macmillan, 1985).
Key documentary sources cited in these books and referenced in this essay include:
Oscar Klioze memo to Jack Freund on Shield stability testing, June 8, 1970
R. W. Nickless, “Orientation Report” on the Dalkon Shield (circulated to 39 executives), June 29, 1970
Fred Clark confidential memo on visit to Hugh Davis, June 8, 1970
Jack Freund memo on inadequacy of Davis follow-up period, June 11, 1970
Hugh J. Davis, “The Shield Intrauterine Device: A Superior Modern Contraceptive Device,” American Journal of Obstetrics and Gynecology 106, no. 3 (February 1, 1970)
Thad J. Earl, “The Shield Intrauterine Device,” American Family Physician (September 1971)
Allen J. Polon memo re: “Destruction of Dalkon Shield Literature,” October 31, 1973
Ellen Preston memo on telephone conversation with Dr. Donald Christian, November 21, 1973
C. Donald Christian, “Maternal Deaths Associated with an Intrauterine Device,” American Journal of Obstetrics and Gynecology 119, no. 4 (June 15, 1974)
E. Claiborne Robins, Sr., internal memo on FDA actions, July 2, 1974
Ellen Preston memo on heat-sealing, December 1974
Roger Tuttle deposition testimony, July 30, 1984 (U.S. District Court, Minneapolis)
Judge Miles W. Lord, remarks to A. H. Robins officers, February 29, 1984 (U.S. District Court, District of Minnesota)
Wayne Crowder deposition testimony, March 27, 1981
Russel J. Thomsen, testimony before House Intergovernmental Relations Subcommittee, May 31, 1973
Russel J. Thomsen, report on AID actions regarding the Dalkon Shield overseas, March 1985
Centers for Disease Control, re-analysis of Women’s Health Study data, American Journal of Obstetrics and Gynecology (July 1983)
Senate Subcommittee on Monopoly hearing on birth-control drugs (testimony of Hugh J. Davis), January 14, 1970
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I have to admit, as much as I hate reading these articles, they are extremely well written and referenced.
I was going to comment on the arrogance and lack of responsibility displayed by some medical and pharmaceutical entrepreneurs...but as no-one takes a blind bit of notice, I'll leave it at that...