In January 1971, the A.H. Robins Co. began marketing an intrauterine device called the Dalkon Shield. It was promoted as a major breakthrough in birth control, and over the next four years an estimated 2.2 million American women placed their trust in its safety and effectiveness.
The legacy of the Dalkon Shield was to be one of human suffering for countless women and a disastrous flood of lawsuits for the company. Thousands of women blamed the Shield for serious pelvic infections. Hundreds conceived with the intrauterine device (IUD) still in place, and miscarried. At least 18 American women who used it died. Others lost their fertility or delivered children with physical defects and brain damage. Nearly a million women overseas used the device. Many of them lived in countries where medical conditions were unsophisticated and fatal complications were more likely.
It has been a decade since the company decided to halt sales of its IUD at the request of the Food and Drug Administration, but the Dalkon Shield is a matter of urgent concern today as much as ever.
Since last October more than 3,200 women have had the devices removed. More than 12,000 women in the United States have sued or brought claims against A.H. Robins. At the end of 1984 there were more than 3,800 suits and claims pending against Robins, and more are being filed at a rate of nearly 10 a day.
Earlier this month, Robins set up a $615 million reserve fund to handle future settlements and court judgments. So far more than 3,700 Shield-related claims have been settled out of court. Of the 50 cases that have reached court judgments, A.H. Robins lost 27 and won 23. In all, Robins and its insurance company have paid out $314.6 million.
William L. Zimmer III, former president of the company and now a director, said in an interview that A.H. Robins "acted with concern and responsibility" in its handling of the Dalkon Shield. All IUDs can cause infections and other complications, Zimmer said, but the Shield, when used properly, was as "safe and effective" as any other IUD. Moreover, when questions about the safety of the device surfaced, A.H. Robins acted promptly to notify the government, physicians, and the public about those areas of potential concern, Zimmer said.
But for many women who used the Dalkon Shield, there is lingering bitterness and a deep sense of loss. One such woman is Mary Kornhauser, 31, a screenwriter living in West Hollywood, Calif. She had excruciating pain from pelvic infections that recurred for seven years. She was in and out of hospitals. At age 25, she said, her womb, Fallopian tubes and ovaries were removed. She sued Robins and settled out of court.
"It's worse than abortion," she said. "Losing the ability to choose whether I wanted a family -- that was the hardest thing for me to get over."
Nor is the tragedy of the Dalkon Shield confined to the generation that used it. Peggy Mample, at 19, gave birth to a daughter, Melissa, who has cerebral palsy. Melissa is 12 now and is confined to a wheelchair for life. She gets around the house by crawling. Robins paid more than $1.4 million for injuries to the child.
Mample, now 32 and living in Boise, Idaho, still has difficulty speaking of the Shield. "I just think it's absolutely incredible that a large corporation can do this to the American public, using us as guinea pigs . . . . The words are hard . . . . I just experienced so many emotions, the anger, the shock . . . what this company did to my child."
Lawsuits brought by Shield users have produced hundreds of thousands of pages of court documents and government transcripts. From these and dozens of interviews emerges a panoramic view of the Dalkon Shield story, from its origins in the 1960s to the embattled company's ongoing efforts to defend itself. The record reveals the inner workings of A.H. Robins every step of the way, pinpointing when questions about the product were raised and how Robins dealt with them.
Nothing in the history of the A.H. Robins Co. foreshadowed the tragedy of the Dalkon Shield. Before it came along, product-liability suits against the firm were extremely rare. For a century the company had concentrated on mostly low-risk medications, such as codeine-free Robitussin for coughs.
The Richmond-based company, which began as an apothecary and grew in recent decades into a multinational firm, long has been controlled by E. Claiborne Robins, the chairman, and his son, E. Claiborne Robins Jr., chief executive officer. The senior Robins has a reputation for philanthropic generosity. He and his family have given more than $100 million to the University of Richmond, and millions more to other civic causes and public institutions. In 1983, Town and Country magazine honored him as one of the five "Most Generous Living Americans." 'We Thought We Had a Good Product'
No product could have had a more auspicious beginning than the Dalkon Shield. The timing seemed perfect. By the early 1970s, assumptions that the popular birth control pill was trouble-free had been shattered. British researchers had linked the Pill to sometimes fatal blood-clotting diseases. Women, doctors, and pharmaceutical companies searched for an alternative to oral contraceptives.
The Dalkon Shield had been developed by Dr. Hugh J. Davis of the Johns Hopkins School of Medicine. Robins executives were impressed by his academic credentials. At the time, medical devices were not regulated. (Not until 1976, in large measure in response to the Dalkon Shield, did Congress move to regulate them.)
The previous owners of the Shield, the Dalkon Corp., had done no studies to directly assess the safety of their IUD. Robins officials said they felt confident about their product, however, because 27,000 Shields had been sold when Robins acquired it and four studies were being conducted at the time.
"We thought we had a good product which took us into a different field," said Zimmer, who said finding a safe means of contraception would be a solution to a "worldwide problem."
But Robins was unaware of the risks, said Roger Tuttle, a former attorney with A.H. Robins who is now a law professor at Oral Roberts University. Robins executives were "blindsided by something that they had no comprehension of," Tuttle said. "I've got to believe that had they known early on what they were dealing with, they wouldn't have touched it with a 10-foot pole."
Said Tuttle: "It was just that one step led to another, until they had a grenade spinning in the middle of the floor."
In Baltimore, Hugh Davis, an assistant professor of obstetrics and gynecology (Ob-Gyn), had been developing IUDs and testing them mainly in Hopkins clinic patients. In 1968, he and a friend, electrical engineer Irwin S. Lerner, came up with what became the Dalkon Shield. To make and sell it, Davis, Lerner, and Lerner's lawyer, Robert E. Cohn, formed a firm that became Dalkon Corp. The Dalkon Shield was a white, nickel-sized piece of plastic with four or five small feet on each side, to be implanted in the uterus. It drew its name from its resemblance to a policeman's badge.
Davis presented himself as an independent expert. He promoted the Shield in many forums. He testified at a televised U.S. Senate hearing. He touted the Shield in books, professional journals and public meetings. He expressed a concern shared by some others at the time that there was possibly a link between the Pill and cancer, and was lavish in his praise of the new generation of IUDs, including the Shield. He claimed it was safer and "just as effective" as the Pill, and was its only worthy successor.
The Dalkon Corp., lacking a sales force, wanted to sell the IUD to a large pharmaceutical house. Schmid Laboratories turned down a chance to buy it. Upjohn Co. made an offer. And, in mid-May 1970, A.H. Robins entered the field.
At a medical meeting in Bedford Springs, Pa., physicians congregated about a Shield exhibit manned by Dr. Thad J. Earl of Defiance, Ohio. Earl was a Shield enthusiast, and by then the Dalkon's fourth co-owner. A Robins exhibitor told his home office of the attention the Shield was attracting and was directed to see if Earl was interested in a deal. He was.
Robins topped Upjohn's offer and bought ownership rights to the Dalkon Shield for $750,000 plus consulting fees and a royalty of 10 percent on all U.S. and Canadian net sales, a figure that ultimately came to nearly $1.2 million.
Robins had no familiarity with the birth control market. It never had made or sold a medical device or gynecological product. No Ob-Gyn was on its staff. It relied on outside consultants for advice.
In September 1970, three months after Robins bought the Shield, international Vice President George E. Thomas wrote Zimmer: "I worry that we seem to have no present or past R&D research and development effort on contraception and contraceptive methods . . . . I worry about the fact that we have no market knowledge or experience in our company, and we are prepared to learn on the job." The memo was marked "Personal & Confidential."
There also were early questions about the new product's safety. Seven months after the Dalkon Shield was being marketed worldwide, Robert S. Murphey, A.H. Robins' vice president for scientific development, wrote in a memo to a dozen company officials: "At present, we possess inadequate support data from animal studies as to the long-term safety of the current Dalkon Shield."
A.H. Robins began a safety-related study in December 1970 that did not begin to yield results for several months. In the meantime, the company declined other offers to conduct early studies, including two at the Medical College of Virginia. "We elected to do some and declined to do others; the explanation is as simple as that," said company spokesman Roscoe Puckett.
It was not the plastic device itself but a slender, three-inch-long string to which it was tied that is blamed for most of the suffering: pelvic inflammatory disease and septic abortions. The thread-sized "tail string" allowed the wearer to make sure the device was in place and ease its removal. It ran from the vagina, a harbor for bacteria, to the sterile uterus. Early Warnings of Potential Danger
Other IUDs used a monofilament string. To the naked eye, the Dalkon Shield's string appeared to be a monofilament, but it was made of hundreds of tiny filaments covered by an open-ended sheath. The minute spaces between the filaments provided internal ladder-like entries by which bacteria could ascend from the vagina into the uterus (the "wicking tendency"), causing infection. A.H. Robins placed two knots in the string to block ascending bacteria.
There were early warnings about the potential dangers of the string. Before A.H. Robins bought the Dalkon Shield, Robins pharmaceutical chemist Oscar Klioze discussed it with Irwin S. Lerner, the president of the Dalkon Corp. On June 8, 1970 -- four days before Robins acquired rights to the device -- Klioze told Robins executives that "the device has not been subjected to any formal stability testing," that is, how it would stand up under prolonged use in the wet, acidic environment of the body.
Seventeen days after A.H. Robins acquired the device, a Shield "orientation report" cautioned about the string. "The string or 'tail' situation needs a careful review since the present 'tail' is reported (by Mr. Lerner) to have a 'wicking' tendency," the late R.W. Nickless of Robins wrote on June 29, 1970. The memo went to 39 A.H. Robins executives. According to the company, a Robins official reviewed the medical literature and concluded that the string did not pose a hazard. That view is still held by the company.
Twelve weeks after Robins began selling the Dalkon Shield, on March 26, 1971, salesman Walter W. Schoenberger of Long Beach, Calif., sent the medical department a query: "What is our Dalkon 'string' made of? Competition (Ortho) is telling my doctors that: it will break, it will fray easily, and that it is 'multilayered' so that the inner core acts as a wick to induce infection into the uterus." The answer came from Robins quality-assurance manager David A. Mefford: "The string is composed of a multifilament surgical suture enclosed in a nylon sheath."
That same month, A.H. Robins employe E. Wayne Crowder said he began asking questions about the Shield. Crowder was in charge of quality control at the Lynchburg, Va., plant where the device was being assembled. That facility was called the Chap Stick plant because it was where Robins made the lip balm. Crowder said he observed two workers tying string to a piece of plastic. "I thought it was a fishing lure," he said.
It was, of course, a Dalkon Shield, and the workers were attaching the string to the body of the IUD. Crowder testified there were no quality-control procedures at the time.
To learn more about the Shield, Crowder visited the original Shield plant in Stamford, Conn. There, Dalkon Corp. President Lerner told him that the two knots in the string would form a barrier against any possible wicking tendency.
Crowder said he was skeptical. He touched the flame of his cigarette lighter to an open string end: it shriveled into a solid bead. "I suggested that heat might be a more positive means of sealing than the knots," he later testified. Lerner "just said he would think about it," Crowder said.
Returning to Lynchburg, Crowder demonstrated heat-sealing to Chap Stick President Daniel E. French, and speculated that string-caused infection could be "extremely serious if a pregnancy should occur."
Crowder said that French termed his concern "reasonable" while predicting that "Robins wouldn't go for it [heat]-sealing. . . . . He said that they had too much time and money invested in testing of the present configuration."
"There is no question," said an A.H. Robins spokesman, "that inside our company there were people who were not scientists who believed the Dalkon Shield tail string might wick, but it was up to scientists in the medical department to determine if this claim of wicking was valid." 'The Open Ends Will Wick Water'
In April 1971, according to his testimony, Crowder spotted "small holes" in the sheath encasing the string, and told his boss of his concern that the holes might let in additional bacteria. "His response was that the design of the device wasn't my responsibility and to leave it alone," Crowder said.
But Crowder said he did not leave it alone. In June, he conducted two primitive tests to see if the string acted as a wick. In one, Crowder put a piece of string in a beaker of water. Several hours later he removed and dried it, and " 'milked' the immersed end of the string with my thumbnail, and produced a small drop of water . . . ." The second test showed that after a few days' submersion, water would seep through the knot.
Crowder said his boss "reminded me as before that it wasn't my responsibility. I told him that I couldn't, in good conscience, not say something that I felt could cause infections. And he said that my conscience didn't pay my salary . . . . He referred to my persistent 'insubordination' [and said that] if I valued my job I would do as I was told."
Like Crowder, Chap Stick President French expressed concern. Apparently hoping to win over A.H. Robins' medical department, he phoned physician liaison Ellen J. Preston on Aug. 5, 1971. Four days later Preston wrote in a memo of that conversation:
"Mr. French says the reason given for the sheath is that it provides protection against bacterial invasion. He points out, however, that both ends of the string are cut and left open. It has been shown that the open ends will wick water. It seems to him if this is so that the ends will wick body fluids containing bacteria."
One month later, on Sept. 2, 1971, Mefford, A.H. Robins' quality assurance director, wrote Oscar Klioze, his superior: "I believe the time to make changes is rapidly approaching." In the memo he expressed concern about "wicking and bacterial problems . . . ."
Mefford wrote: "I don't intend to initiate any of these changes because for the most part they are medical or marketing decisions . . . . Most changes would have slowed down production and with the supply so critical, this would have been unwise."
Suggestions to change the string were rejected. Klioze told French on Sept. 7 of the consensus of the Research Committee that "the Shield continue to be manufactured according to present specifications until management directs otherwise." French assured Klioze two days later that he would not "attempt any unauthorized improvements," adding, "my only interest in the Dalkon Shield is to produce it at the lowest possible price, and . . . increase Robins' gross profit level."
Crowder was fired from the company in 1978 and is now suing it in a contract dispute. His heat-sealing concept, said a company spokesman, "looks like a nice idea, but it has never been shown scientifically that it would work . . . . If it had been a thing deemed necessary for the safety of the device, it would have been done."
Common sense, Crowder said, might have averted the problem with the string. "To me it did not seem at the time, and still does not seem, that the question is as scientific as the investigation after the fact has made it appear. It was not a situation where exceptional genius was required to understand the hazards of the design."
"I felt like the person who discovered a smoldering fire in a building. I thought, 'Get the information to the authorities at Robins and it would be taken care of,' " Crowder said in a recent interview. "I felt a great sense of disappointment, maybe betrayal, frustration." A Postscript
Crowder's heat-sealing concept was not forgotten. In December 1974, five months after the Dalkon Shield sales were halted in the United States, A.H. Robins' Ellen Preston sent a memo to Frederick A. Clark Jr., the company's medical director: "It is too late to 'heat seal' now. We need to abandon the 'multifilament' string. Heat-sealing would have been a good thing to have done 4 years ago."
NEXT: Promise and pain