JANUARY 15, 1986 - VOLUME 7 - NUMBER 1
A Crime Against Women
A. H. Robins and the Dalkon Sheildby Morton Mintz
For almost 15 years the executives of the A.H. Robins Company have undauntedly stood behind their most famous product-the Dalkon Shield. Even today, after thousands of women who wore the Shield have suffered pelvic infections, sterility, spontaneous abortions and death, the company continues to deny that the design of their product is at fault.
In January 1971, the A.H. Robins Company began to sell the Dalkon Shield, promoting it as the "modern, superior," "second generation," and-most importantly-"safe" intrauterine device for birth control. Robins, a major pharmaceutical manufacturer in Richmond, Virginia, distributed 4.5 million of the IUDs in eighty countries before halting sales in the mid-1970s. There followed a catastrophe without precedent in the annals of medicine and law.
The seriously injured victims number in the tens of thousands. Nearly all suffered life-threatening forms of the infections known as pelvic inflammatory disease (PID). In the United States alone, PID killed at least eighteen women who had been wearing Shields. Most of the infections impaired or destroyed the women's ability to bear children.
Not only was the Shield unsafe, it was surprisingly ineffective. The number of wearers who became pregnant with the devices in place was on the order of 110,000, or 5 percent-a rate nearly five times the one falsely claimed in advertising and promotion to physicians and women, and a rate sharply higher than that for many other IUDs. More than ordinary commercial puffery, the exaggerated and bogus claims led women to reject more effective birth control in favor of the Shield; and this led directly to consequences far worse than unwanted pregnancies. Statistically, half of all women who become pregnant with an IUD miscarry. But in fact, of the estimated 110,000 women who conceived while wearing the Dalkon Shield, 66,000-or 60 percent-miscarried. Most suffered the previously rare miscarriages called spontaneous abortions in either the first or second trimester. Others, in the fourth to sixth months of pregnancy, experienced the still rarer infected miscarriages, or septic spontaneous abortions. By the count of the Food and Drug Administration (FDA), 248 women in this country alone endured this dangerous, Shield-related complication; for 15 of them, these septic abortions were fatal.
Moreover, hundreds of women throughout the world who conceived while wearing the Shield gave birth prematurely, in the final trimester, to children with grave congenital defects including blindness, cerebral palsy, and mental retardation, or that were stillborn. No one can pinpoint the exact number of such women, partly because no one knows how many times women or their doctors failed to make a proper connection between the Shield and the premature birth of a defective baby.
Robins distributed about 2.86 million Shields in the United States, and doctors implanted them, by the company's estimate, in 2.2 million women. Abroad, Robins distributed about 1.71 million Shields, and in June 1974 it estimated that 800,000 to one million were implanted. The Agency for International Development (AID) bought more than 697,000 Shields for use in the Third World. Whatever the precise numbers of Shield insertions in African, Asian, Middle Eastern, Caribbean, Latin American, and South American countries, poor medical conditions made lethal complications more likely. If a Shield wearer became infected, "where there are no doctors, no antibiotics, she's going to die," said Dr. Richard P. Dickey, a former member of the FDA's obstetrical and gynecological devices advisory panel.
The A.H. Robins Company twice explored the possibility of buying the rights to an intrauterine device. The first time was in 1965, when Dr. Jack Freund, the vice-president who headed the medical department, became interested in the Lippes Loop. The second time was in 1970, when the Dalkon Shield became available. The Loop episode was a dry run, in a sense; it offers a glimpse of the considerations that influenced the Robins executives.
Dr. Freund asked Dr. Frederick Clark, the medical director, for what Clark called "preliminary comment on the IUCD [intrauterine contraceptive device], with specific attention to the Lippes Loop."
On July 12, 1965 Clark wrote a memo listing the pros and cons. One favorable entry was, "Trend is up and likely to continue. Old fears on use receding." A second "pro" was that a new-drug application (NDA) would not have to be filed with the FDA. The absence of an NDA requirement arose from an absurdity in the Food, Drug, and Cosmetic Act that would play a crucial role in the Dalkon Shield disaster.
The 1938 law as amended in 1962 requires a manufacturer to submit to the FDA an expanded NDA showing "substantial evidence"-derived from adequate and wellcontrolled clinical investigations-of effectiveness in the uses for which the company was recommending the product, including reliable and sufficient animal and clinical testing for safety.
But the law had a ridiculous loophole: with no premarket clearance, a manufacturer could put on sale an untested, hazardous device. Only after it had caused injury or death could the FDA-if it was prepared to carry the legal burden-go to court for an injunction to halt interstate sales.
Like so much legislation that would benefit the public rather than special interests that finance political campaigns, a device bill had always lacked an active constituency. This made it easy for Congress to turn its back on the fundamental contradiction; if it required the FDA to regulate a drug taken into the body for a specific purpose, such as birth control, how could it not compel the agency to regulate a device inserted into the body for an identical purpose?
The indications are overwhelming-from the history of the Robins company, from the words of both the elder and the younger Robins, and from innumerable documentsthat had a device law been on the books, the company would never have seriously considered the Dalkon Shield. Without regulation, the company could be in the birthcontrol market in a matter of months. With regulation it would have to monitor 1,500 to 2,000 users for no less than two years and then submit the results to the FDA. Without regulation, it could put the Shield on sale without prior testing for safety in either animals or humans.
In the end, in the case of the Lippes Loop, the highest levels of the Robins Company decided not to acquire the device. In 1970, Robins, which had specialized in bowel and cold medications through most of its first century, got a second crack at the IUD market. Less than a month after they had been approached about buying the Dalkon Shield, Robins officials signed the papers buying the patent rights to the Shield for $750,000 from the Dalkon Corporation.
By late 1970, the A.H. Robins Company had trained an aggressive force of several hundred salesmenwho had never sold a gynecological product and who seldom if ever called on obstetrician-gynecologists-to sell Dalkon Shields. Robins estimated the production cost of a Shield, to be priced at $4.35, would be only twenty-five cents. Although it carefully examined marketing and manufacturing, A.H. Robins, like the Dalkon Corporation before it, had not undertaken to test the Shield for safety in either animals or women. The only study of efficacy--lone by Hugh Davis-had been questioned by Robins's own senior physicians.
Not only did Robins fail to initiate its own testing; it actively turned down a series of proposals form outside the company for studies that had the potential to provide an early warning of the pelvic infections that would turn up in actual use.
In January 1971, Robins began to sell Dalkon Shields in the United States and ultimately in seventy-nine other countries. The marketing campaign was a dazzling success. Over the next twelve months, according to company estimates made for internal purposes, 56 of each 100 IUDs inserted in American women were Shields; in 1972, 59 of each 100.
On June 23, 1972, almost two years after Robins purchased the Shield, a Midwestern physician sent an alarming letter to A.H. Robins. Six women in whom he had implanted the Dalkon Shield had become pregnant while it was in place, and five of them had gone on to suffer lifethreatening spontaneous infected abortions. His report was not the first to link the Shield to infected pregnancies. Rather it was the sheer number in a single physician's experience that made the report ominous. Yet another aspect made the warning unique, and that was its source: Thad Earl-an Ohio general practitioner who was one of the very first physicians to insert the Shield and who, even then, as a $30,000-a-year consultant to Robins, was busily promoting it. Earl's warning had the potential, in the judgment of Bradley Post, a leading plaintiffs' attorney, to save "most of the women who have been killed and maimed by this device."
In late May 1974, almost two years after Thad Earl's warning and amid increasing problems associated with the Dalkon Shield, FDA officials asked the company to halt distribution until the bureau's OB-GYN advisory committee could take up the matter at a two-day meeting in early June. The company declined. Its reasons are illuminated by a May 24 memo, brought to light by later litigation: ". . . if this product is taken off the market it will be a`confession of liability' and Robins would lose many of the pending lawsuits."
On May 30, the Center for Disease Control told the FDA of the results of the questionnaire it had mailed in 1973 to 35,544 medical and oteopathic physicians. The survey yielded reports on 3,502 women who were hospitalized with IUD-related disease and injury in the first six months of 1973. The key findings, not made public for several weeks, were dismaying for Shield wearers.
The ratio of "complicated pregnancies to other diagnoses is twice as high for Dalkon Shield wearers as it is for all other (including unknown) types of IUDs," the survey found. Moreover, among the hospitalized women who have never borne a child and were fitted with small-size IUDs, more than 73 percent had worn Shields. The incidence of pregnancy with complications was 61.6 percent among Shield wearers, compared with 29.6 percent for the Lippes Loop and 6.9 percent for the Saf-T-Coil. For pelvic infection: Shield, 49.8 percent; Loops 32.6 percent; Saf-TCoil, 7.7 percent. For "other infection": Shield, 50.8 percent; Loop, 30.2 percent; Saf-T-Coil, 9.5 percent.
At the June meeting, the FDA's device advisers concluded that in preventing pregnancy, the small-size Shield "is less effective than other IUDs," while the standard-size Shield "is no more effective and possibly less effective." They also concluded, 5 to 0, with two abstentions, "that the risk of septic abortion and septicemia is greater than with other IUDs." Furthermore, they judged, 4 to 2, that the Shield carries a comparatively greater risk of death. Finally, by a vote of 4 to 3 they recommended withdrawal of the Shield from the market "for a lack of demonstrated safety." As of that time, according to Robins's testimony, the company knew of six fatal and seventy nonfatal spontaneous septic abortions in American Shield users.
On June 24, officials with the FDA's device bureau urged FDA Commissioner Alexander Schmidt to take a forceful action: ask Robins to cease distribution of Shields and "recall all stocks of the device which have not been implanted." If Robins refused, Dr. Schmidt would designate the Shield a"health hazard" and order a "Class 1 Recall." This would enable the agency to get a court injunction.
The drug committee then met and evaluated the same body of information. Without spelling out its reasons, it voted, 4 to 2, simply to recommend withdrawal of the Shield from the market.
FDA officials, however, rejected the recall and withdrawal concluding that "the inability of the advisory committees to come out with something more forceful" left the agency unable "to support the charge that the device was a hazard to health."
Meanwhile, Robins, accepting the inevitability of some kind of agency move, sought the weakest possible regulatory action, a legally voluntary suspension of sales, because it would inflict the least damage on the company's defense against Shield lawsuits and on its reputation. Moreover, the company would be free to resume sales of the Shield if it would develop a safer model.
On June 26-after the reported toll of fatal spontaneous abortions had risen to 7 and of nonfatal to 103-Commissioner Schmidt accepted Robins's proposal to suspend sales, pending a hearing by the two FDA advisory bodies. The FDA and Robins announced the action two days later.
Inside the company, Claiborne Robins, A.H. Robins chief executive officer, was jubilant. He had once again managed to dodge regulation and get the FDA to do precisely what he wished. He sent an exultant memo that hinted at how a regulatory staff trying to protect the public can be blindsided by corporate legions with access to agency bosses. Stated the memo: "I would like to congratulate you... for the outstanding job you all have done... 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 teams which had been working constantly with the FDA during the period leading up to the announcement."
Although Robins had agreed to suspend sales in the United States in 1974, the company continued to distribute Shields abroad for as long as nine months-"at the request of. .. specific governments," Robins swore at a deposition in January 1984. Asked who had told him that, he replied, "I don't know that. It seems to me I saw a memo somewhere, but I don't remember when or where."
In El Salvador in 1975---a year after the suspension of Shield sales here the only ND some clinic's doctors were inserting was the Shield. Some clinics in El Salvador continued to implant Shields until 1980.
By 1983, however, the manufacturer of the Dalkon Shield had seen grim omens appear in three cities. In St. Paul, federal juries made two awards of punitive damages to Shield victims, one for $1,750,000 and another for $50,500. These dealt a heavy blow to the A.H. Robins Company, partly because it had no insurance coverage for exemplary damages, and partly because the awards would inevitably encourage other victims to seek to punish the manufacturer.
In Philadelphia, a federal jury, barred from awarding punitive damages to a Shield user who had suffered a pelvic infection and loss of her ability to bear children, set a record for compensatory damages: $5.15 million. This was bad news for Robins, but perhaps worse for Aetna Casualty & Surety Company which, in its 1977 agreement with Robins, had undertaken to pay the bills for all awards of compensatory damages-even those arising from "the supplying of false and misleading information."
From the vantage point of Robins and Aetna, however, a development in Minneapolis on December 9 was the most ominous of all: the six federal judges of the District of Minnesota assigned twenty-one Shield cases to Miles W. Lord, the activist, blunt-spoken Chief Judge. Over the next three months, Lord would be intensely and personally involved in trying to expedite Shield litigation, which was clogging the federal and state courts of Minnesota. (See Lord's Justice, p.6.)
For Robins, the growing number of awards of punitive damages had become a plague. In the February 29, 1984 package settlement, Robins had to pay $2,050,000 to dispose of two jury awards of punitive damages. On June 4, the Colorado Supreme Court upheld the record $6.2 million award of punitive damages. Strikingly, Robins paid the award rather than appeal. On June 6, a jury made a $1.4 million exemplary award to Melissa Mample, a cerebral-palsied child in Boise, Idaho, whose mother had given birth with a Shield in place. By June 30, juries had awarded punitive damages in eight cases, totaling $17.2 million. Shield victims who specified only the exemplary awards had filed suits in excess of $12 billion more.
For relief, Robins turned to the United States Senate, where the Commerce Committee had before it a bill to establish national uniform standards for the liability of manufacturers whose products are alleged to have caused avoidable disease and injury to consumers and workers. In addition to President Reagan, two large coalitions of about three hundred businesses and trade associations supported the bill, whose principal sponsor was Senator Robert W. Kasten, Jr. (R-Wis.). Over a period of four years starting on January 1, 1979, their political action committees gave $626,918 to members of the Commerce Committee. A new committee member, Paul S. Trible, Jr.-a Republican from Robins's home state of Virginia-received $117,593, the largest single share.
In early 1984, it was Paul Trible who introduced an amendment under which a manufacturer of any kind would have to pay punitive damages only once-to the first litigant to persuade a jury that the company had been grossly negligent or had recklessly disregarded safety.
A few days later, a Trible spokesman told me that the senator had introduced the amendment-which critics called "the Robins bail-out"-after being contacted by Robins.
Trible's amendment aroused the anger of women's groups, trial lawyers, consumer advocates, unions and newspapers. Sensing the threat to his political future, Trible first said he would weaken his amendment and then dropped it altogether.
Although Robins was increasingly embattled, its status as a large, international conglomerate with diverse lines of business and some thirty foreign subsidiaries protected it financially. This was reflected in the company's report for the three months ending June 30, 1984. Because of a 430 percent increase in Shield litigation expenses, the company said, net earnings fell 70 percent, to $4,069,000. But sales rose 11 percent to $151,992,000-the best second quarter in Robins's history.
Still, the Shield took its toll. On April 2, Robins held a press conference in Richmond to announce the creation of a $615 million reserve fund for paying Shield claims until the year 2002. The payment through December 31, 1984, having been $314.6 million, the total now would approach the $1 billion level. G.E.R. Stiles, senior vice-president and financial officer, revealed that a study by an outside consultant indicated that the Shield may have injured roughly 87,000 or 88,000 of the 2.2 million American women who wore it, that the ultimate total of those who would sue or file claims would be approximately 20,000, and that the $615 million would suffice for compensatory damages for all existing and expected claims. But Stiles left considerable doubt that the $615 million would be adequate, mainly because it allowed neither for punitive damages-although billions of dollars in such damages were being sought-nor for lawsuits by foreign Shield users, who by 1985 had begun to sue Robins in American courts.
Even without such future woes, the $615 million fund caused Robins to report a 1984 net loss of $416 million, a sum larger than the company's net worth, and large enough to wipe out all shareholder dividends through the end of 1986.
The setbacks for Robins continued into 1985. On January 21, the Eleventh United States Circuit Court of Appeals in Miami ruled that Dr. Louis Keith, the long-time Robins consultant and Northwestern University professor of OB-GYN, might have committed perjury, and the FBI began an investigation.
On February 21, special masters Peter Thompson and Thomas Bartsh, who had been sent to Richmond a year earlier to seek compliance with judge Lord's documentproduction order, filed a report. Their summary began:
We conclude that Plaintiffs have established a strong prima facie case that A.H. Robins Co., Inc., has, with the knowledge and participation of in-house counsel, engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safety, and efficacy of the Dalkon Shield. The ongoing fraud has also involved the destruction or withholding of relevant evidence.
They said of the four studies cited in the eight-page "Progress Report" advertisement that Robins published in the final four months of 1972: "Robins officials knew that the results of the studies were inaccurate and misleading."
On May 3, 1985, in Wichita, a Sedgwick County jury awarded punitive damages of $7.5 million-a new record in Shield litigation-and $1.1 million in compensatory damages to Loretta Tetuan, thirty-three, who lost her uterus and ovaries after wearing a Shield for nine years.
On August 21, a startling development occurred in Judge Merhige's court in Richmond, one that caused the price of a share of Robins's stock to fall to $8 from a 1985 high of over $24, and one that made most every front page in the country. The company asked to be allowed to reorganize under Chapter 11 of the Bankruptcy Code, so that it could be protected from lawsuits by creditors-Shield victims, above all-while it devised a plan to pay its debts. Robins did not claim to be financially shaky. Rather, it invoked "the continuing burden of litigation," much as the financially healthy Manville Corporation had done in 1982, when it pioneered using Chapter 11 as a refuge from lawsuits, brought in its case by victims of asbestos-related diseases.
The next day, Merhige suspended proceedings in thousands of Shield lawsuits, saying that "everything is stayed in every court." Many plaintiffs' lawyers denounced Robins for a "sham" and 'unjustified" action that would let it pay everyone to whom it owes money except Shield victims.
On August 23, a motion to dismiss Robins's petition was filed by the National Women's Health Network, which twice had sought worldwide Shield recalls-in a 1981 court action and in a 1983 FDA petition.
Today, more than a decade after Shield sales officially ended, its legacies of death, disease, injury, and pain per sist. Even women who have had the Shield removed are not out of danger. Because PID is not an affliction that is simply treated and is then over and done with, large numbers of former Dalkon Shield wearers suffer chronic pain and illness, sometimes requiring repeated hospitalization and surgery; many have waged desperate battles to bear children despite severe damage to their reproductive systems. Not even women who currently wear the Shield with no apparent problem are safe: they run the risk of suddenly being stricken by PID. In the words of judge Lord, they are wearing "a deadly depth charge in their wombs, ready to explode at any time."
The exact number of women sill wearing the Shield is unknown. By early 1983, some Food and Drug Administration officials and OB-GYNs were confident that few American women, probably only hundreds, still used it. Other qualified observers, however, were estimating the figure to be much higher, anywhere from 80,000 to more than half a million. Certainly the response to Robins's own call-back campaign of October 1984 suggests that the higher figures are closer to the mark. By February 1, 1985, a $4-million advertising drive, which urged women still wearing the Shields to have them removed at Robins's expense, had drawn more than 16,000 phone calls on tollfree hotlines; by the end of March, 4,437 women had filed claims for Shield removals. The claims were flowing in at the dramatic rate of more than one hundred a week.
And what of women in the seventy-nine other countries where the Shield was distributed? The company told the FDA that it had notified first the countries' ambassadors in Washington and then their senior health officials at home of its Shield-removal campaign in the United States, and had "sought direction on whether a similar program would be appropriate in those countries.' By early April 1985, Australia, Canada, and the United Kingdom had requested, and the company had put into effect. one or another kind of removal program. New Zealand, too, was considering a program. Sixteen other countries had simply acknowledged receipt of Robins's letter Eight others-Denmark' Mexico, Norway, Pakistan. the Philippines, South Africa, Tanzania, and Zambia-had declined any removal program. From the rest of the countries, of which there were fifty-one, Robins had received no response almost a halfyear after inviting one. If this record suggests indifference to the health and safety of women, at least partial explanation may be found in the company's adamant refusal to admit to the special dangers inherent in its device. "Robins believes that serious scientific questions exist about whether the Dalkon Shield poses a significantly different risk of infection than other IUDs," it said in an interim report to the FDA.
Another measure of the extent of the damage is provided by the lawsuits and unlitigated claims filed by Shield wearers in the United States. Nearly all of these women had suffered PID followed by damage to or loss of their ability to bear children. Through June 30, 1985, by the company's own count, the total number of cases was 14,330 and new ones were being filed at a rate of fifteen a day. Through June 30, 1985, Robins and its former Shield insurer Aetna Life & Casualty Company, had paid out $378.3 million to dispose of cases, plus $107.3 million in legal expenses. Juries have awarded $24.8 million in punitive or exemplary damages, which are intended to punish wanton or reckless behavior and to deter its repetition or emulation.
Still, no summary of suits and claims can come close to accounting for the total number of Shield injuries. By Robins's own conservative estimate in April 1985, 4 percent of the wearers were injured-that is, nearly 90,000 women in the United States alone. It was 10 years after Robins was forced to discontinue sales that the company began a recall. Surely it is reasonable to suggest that many Shield victims might not have died, and that thousands of other women would not have suffered pain and agony, if Robins had acted earlier. But Robins consistently claimed-and continues to claim-that the Dalkon Shield was safe and effective when "properly used." Robins executives insist that they did not know of any special hazard. But they did know, and they chose to do nothing-until it was too late.