Dr. Lindsay R. Curtis, an Ogden, Utah, gynecologist, visited the A.H. Robins Co. in June 1972 and announced to company executives that he and physicians he worked with would no longer use the firm's new IUD, the Dalkon Shield.
He told them about a 25-year-old woman who became pregnant a month after the Shield was inserted, whose fever climbed to 105 degrees and who gave birth to a premature and stillborn baby. The woman is Curtis' daughter.
A few days later, a Robins physician, Dr. Ellen J. Preston, wrote Curtis: "Needless to say we were disappointed to hear that your experience had not been altogether favorable, particularly with regard to serious pelvic infection . . . . We have received other reports of PID [pelvic inflammatory disease] occurring in Dalkon Shield wearers, but the reports have been very infrequent."
The experience of Curtis' daughter, and other cases like it, marked a turning point for Robins and the Dalkon Shield. By mid-1972 Robins had sold the Shield for a year and a half and more than a million U.S. women were using it. But in the midst of such financial success, physicians' observations and suspicions began to trickle in to Robins. From medical conventions and seminars came stories of pregnancies, infections, even deaths.
Eventually, Robins and others undertook studies, government agencies and Congress stepped in, and on June 28, 1974, Robins halted Shield sales in the United States. But the awareness of trouble began with doctors trying to deal with what they saw as their own isolated problems.
On June 23, 1972, three days after Curtis met with company officials, Robins got more bad news. Dr. Thad Earl wrote from his Ohio clinic to say he had heard complaints from other doctors of high pregnancy rates, difficulty inserting and removing the device, and pelvic infections among patients using the Shield. More alarming, Earl said, was that five of his patients became pregnant with the Shield in place and apparently had infection-related miscarriages.
Earl's relationship with Robins was unique. He was one of the earliest and most stalwart champions of the Shield and an investor in the device. Two years earlier Robins had paid him $56,250 for his interest in the Shield, plus tens of thousands of dollars in royalties and a $30,000-a-year consulting fee.
Earl's letter warned of a possible link between the Shield and miscarriages in the second trimester of pregnancy -- a condition rare in the general population.
"I am advising physicians that the device should be removed as soon as a diagnosis of pregnancy is made," he wrote. " . . . I therefore feel it is hazardous to leave the device in and I advised that it be removed. I realize that this is a small statistic but I feel we should correlate this data with other investigators across the country, because most [physicians] are experiencing the same problem."
Earl sent his letter to several Robins officials, including Shield project coordinator Kenneth E. Moore. Moore, in turn, sent copies to 10 more officials. He attached a four-page memo to Earl's letter. Of the "tide of higher-than-expected pregnancy-rate reports," Moore wrote, "the most logical explanation . . . is proper versus improper insertion technique."
"I would like to call attention to Earl's suggestion that the Dalkon Shield be removed as soon as a diagnosis of pregnancy is made," wrote Moore. "This is completely in reverse of what we have been recommending . . . . "
Despite its wide circulation, Earl's letter apparently did not get the attention of Preston, Robins' liaison with the medical community on the Shield.
"So I didn't read the letter, it went to the files, and did not come directly to my attention till some months or even a year or so later," Preston has testified. "I say that does not excuse my not reading it, but at least it is the reason I think that . . . I didn't say something to somebody . . . . "
Robins says it replied to Earl on Aug. 22, 1972, a response Earl says he never received. Moore's letter to Earl, now a part of court records, suggested that several of the problems raised in Earl's letter were the product of a campaign to discredit the Shield, presumably by competitors. Moore wrote: "I think one of the most important observations you made is the one pertaining to the part money and politics may be playing in derogatory statements made about the Shield. We have received evidence of such on a number of occasions through our sales representatives and plan to take steps shortly to combat it."
Alexander H. Slaughter, an attorney representing Robins, said the company took Earl's letter seriously, but did not consider the cases as described by Earl to be instances of septic, or infection-induced, abortion. He said company policy at the time was to allow the device to remain in place until the woman went to term, a view held by many physicians who believed that was safer for the fetus than removal of the device. Dr. Christian's Doubts
On Oct. 8, 1972 a 31-year-old Arizona woman was fitted with a Shield. Several weeks later her doctor told her she was pregnant. He left the device in place, a practice common at the time. On March 27, 1973, she complained of a sense of fullness in her abdomen and of a "flu-like syndrome." There seemed little cause for alarm; her two children had flu.
At 4 in the morning on March 29, she was taken to the hospital shaking uncontrollably from chills. She had a 103-degree fever. A short time later she aborted her 19-week-old fetus. Seventy-two hours after the first symptoms of "flu" appeared, she died.
Dr. C. Donald Christian, head of the obstetrics-gynecology department at the University of Arizona Medical Center in Tucson, said he was perplexed by her death.
Several months later, he said, he learned from a Texas physician of two Shield-wearing patients who also apparently had suffered miscarriages and died soon after.
One was a 24-year-old mother of two who had been fitted with a Shield in January 1972 and conceived 3 1/2 months later. In the fourth month of pregnancy, she developed symptoms suggesting flu: sore throat, fever, nausea, vomiting. Two days later, she entered a hospital. The next day, she aborted. The day after that, she died.
Christian said he was struck by the similarities in the cases. He later wrote that "the greatest concern is the rather insidious yet rapid manner in which these patients become ill . . . . The first symptoms, which were disarmingly innocuous in and of themselves, occurred within 31 and 72 hours of death . . . . " By the time the true nature of the infection is clear, he wrote, "the margin of safety that time ordinarily provides in treating such infections is not present."
Christian questioned doctors in other states and learned of similar deaths. He contacted the Centers for Disease Control, the Food and Drug Administration and Robins. The FDA "kept telling me to go away, in essence," he said.
A Nov. 21, 1973 memo by Preston, Robins' medical liaison, summarized her conversation with Christian.
He told her that while traveling across the country he had asked other doctors if they had problems with IUDs. He learned that they did, and that often the device involved was the Dalkon Shield, according to Preston's memo. He told her that several women who were using the Shield had died recently, and that that information "had been supplied to the president of [Robins] way back in the spring of 1973."
"The company," Christian told her, "had done nothing about the information and had assumed a very 'unstatesmanlike' attitude toward this very serious problem of sepsis and septic infection-induced abortion with deaths associated with the Dalkon Shield."
Preston wrote that she told Christian, "I would be happy to follow up on any cases of deaths that came to our attention . . . that was why I was calling him today . . . . I inquired as to whether the three deaths he had collected were all associated with pregnancy. He replied that was the whole point. I suppose that was intended to mean that I had asked a dumb question."
Christian offered to share his knowledge face-to-face. "I had been desperately trying to get Robins' attention, and I was happy to have her come out here and look at my materials," Christian recalled.
Preston visited him in Tucson on Dec. 10, 1973, and told him, she wrote in a memo, "that we wanted to do what was right about it and we needed his help."
Christian, according to Preston's memo, told her that he had evidence of fatal spontaneous septic abortions in Shield wearers and believed that there was a link between them.
"He brought up what he might do with the information he had," Preston wrote. "He intends to publish it, I think . . . . He pointed out that he could call the editors of several journals and get it published in their next issue with a black border around it, etc., and that would be the end of the Dalkon Shield . . . . "
Christian said later, "I think I got her attention, finally."
According to Preston's memo, Christian "pointed out that he thought we followed a poor policy having our salesmen deny any problems . . . . He recommended that we advise our salesmen concerning these deaths."
But he "conceded at once that perhaps at that point . . . we actually did not have any information," Preston wrote. "I emphasized that we did not."
The American Journal of Obstetrics and Gynecology received a draft of Christian's article describing the cases of spontaneous septic abortions on Dec. 24, 1973. About the same time, Robins offered to present its data on the subject to an FDA advisory committee.
A Robins spokesman disputes Christians' account. He says it was the company that sought out Christian and that Robins learned of the first woman's death before talking to him. The spokesman said Robins promptly contacted the woman's physician to get more details, but that the physician told the company that he considered the case to be an isolated incident of "very little meaning of itself."
Former Robins president William L. Zimmer III said in an interview that the company also notified the FDA and decided to convene a panel of its own on the subject.
The "Conference on Septic Spontaneous Abortion" met on Feb. 15, 1974. Among the 12 conferees invited to attend were five paid members of the Robins Advisory Panel on Family Planning and Birth Control. Christian also participated, and toward the end of the conference he asked: "Do the physicians here believe there is an increased risk of serious sepsis in pregnancy patients with Dalkon Shields as compared to those patients with other devices in the U.S.?"
The vote was five "yes," five "no," and two abstentions, according to Robins' "confidential" minutes. How the five Robins-paid advisers voted is not known.
Robins later interpreted the split vote in a light favorable to the Shield. On June 11, 1974, company executives appeared before an FDA hearing examining possible links between spontaneous septic abortions and the Dalkon Shield. Robins medical director Dr. Frederick A. Clark Jr. told the FDA: "We also convened our own Robins advisory panel plus invited conferees to discuss these reports. The conference concluded that there was insufficient information to establish that a unique association existed between the events and the Dalkon Shield."
Christian said he and others felt frustrated after the conference, and were disappointed that information they thought important was not shared with them.
Robins says the conference participants who were from Robins' advisory panel were distinguished experts who had received only minimal sums of money from the company and that nothing critical was withheld from the other participants. They cite a Feb. 28, 1974 letter from Christian praising the company's "responsible and objective manner," and say that as a result of the septic abortion conference Robins alerted physicians about its concerns.
On May 16, 1974, Robins sent out a "Dear Doctor" letter to an estimated 100,000 physicians. It advised removal of the Shield on confirmation of pregnancy, as Earl had suggested 20 months earlier. It cautioned about potential severe complications and said prospective users should be told that an accidental pregnancy could make therapeutic abortion desirable.
The letter asked that details of other such cases be sent to the company or to the FDA. "Although the significance of the septic abortions for the Dalkon Shield, specifically, is still uncertain," the letter said, "we feel it essential to make this information available to minimize the likelihood of similar problems among your own patients."
Zimmer said, "I look at the record and I just can't help feeling that the company acted with concern and responsibility."
Preston was asked later if one purpose of the letter was "to get a jump on Dr. Christian's article."
"Well," she said, "that might have been a factor that was discussed, but I don't think that's the primary reason the letter was sent."
The success of the Dalkon Shield was unraveling daily, its popularity plummeting. On May 22, 1974, three officials of the FDA's Ob-Gyn devices bureau asked Robins to halt Shield distribution until its advisory committee could discuss the matter at a two-day meeting in early June.
Two days later, unrelated to the FDA development, a Robins official wrote: "There are many opinions as to what will happen to the sales of this product in face of the recent 'Dear Doctor' letter. The sales/marketing division is somewhat more pessimistic on this than the R&D/medical personnel . . . all individuals interviewed agreed that we should not take it off the market."
Sales for the first four months of 1974 were nearly half what they were during the same period of 1973. The company halted all promotional literature. Still, Robins believed there was good reason not to take the Shield off the market. One reason was cited in the May 24, 1974, memo:
"It is the opinion of Mr. Tuttle [Roger L. Tuttle, then one of Robins' attorneys] that if this product is taken off the market it will be a 'confession of liability' and Robins would lose many of the pending law suits. At this time there are 47 suits pending for a total amount in excess of $25 million.
" . . . Also the point was made that whether this product were taken off the market or allowed to die slowly, there would still be lawsuits 'in process' for as long as 10 years in the future."
By the end of May, the Shield had come under scrutiny by the Planned Parenthood Federation of America, which warned Shield-wearing patients that they faced "a serious risk" if they conceived. Also in May, the U.S. Centers for Disease Control reported to the FDA the results of a questionnaire that showed a significant increase in the number of complicated pregnancies and pelvic infections among users of the Shield compared with other IUDs.
Postscript: On June 15, 1974, Christian's article was published in the American Journal of Obstetrics and Gynecology. Christian again tried to sound the alarm and his impatience with government regulators was manifest: "This all invites the much larger question of whether there should not be more rigid evaluation and control of medical devices. Certainly, if there were five botulism deaths from one type of mushroom soup, the Food and Drug Administration would do more than put out a questionnaire." 'Questionable Safety'
On June 24, 1974, officials of the FDA medical devices bureau recommended in a draft report that the agency ask Robins to stop selling the Shield and recall all stocks of the device "because of the health hazard." If Robins refused the recall, the memo said, the FDA should be prepared to get an injunction and seize shipments of the IUDs.
Two days later, FDA Commissioner Alexander M. Schmidt wrote to company Chairman E. Claiborne Robins to tell him that it was the conclusion of two FDA committees that "the Dalkon Shield should be withdrawn from the market because of its questionable safety."
"In the interim," wrote Schmidt, "because of the committee's concern over the safety of the Dalkon Shield, which concern is supported by 110 reports of septicemia associated with spontaneous abortion, including seven deaths, I request that you immediately cease further commercial distribution of the Dalkon Shield . . . . "
On June 28, the agency issued its press release:
"The Food and Drug Administration today announced that the A.H. Robins Co., . . . after conferring with the agency, will suspend distribution and sale of the Dalkon Shield . . . until the agency can determine if the device is less safe than other IUD products . . . . Dr. Schmidt emphasized that the agency has no reason to believe at this time that physicians should remove the Dalkon Shield from patients now wearing the Robins' IUD successfully. He also cautioned patients using the Dalkon Shield against undue alarm."
For Robins, the release apparently brought some sense of relief that stiffer governmental action had not been taken.
In an internal memo written July 2, 1974, Chairman Robins told his employes that they "performed a seemingly impossible task . . . . We had all felt that the decision would be political, and to have Dr. Schmidt announce his action -- taken against the vote of the panels -- was indicative of the input of our team which had been working constantly with the FDA during the period leading up to the announcement."
Robins concluded that the joint release "helped reinforce our image as an ethical pharmaceutical company, which places the safety and efficacy of our products in a primary position."
In December 1974, the FDA announced that Robins could resume sales of the Dalkon Shield under a "patient registry system." Robins decided against returning the product to the market.
Six years later, on Sept. 25, 1980, the company sent out another "Dear Doctor" letter, urging that any women still using the Shield should have it removed. It was not, said the company, that the Shield presented unique hazards, but that any IUD left in the body that long presented a health risk.
On Oct. 29 of last year, the company started an advertising campaign urging women to have the Shield removed at Robins' expense. More than 4,400 women came forward and had the device removed.