AT ANY COST
Mintz, Morton
Cashing in At Any Cost Corporate Greed, Women, and the Dalkon Shield BY MORTON MINTZ In January 1971, the A.H. Robins Company began to sell the Dalkon Shield, promoting it as the "modern,...
...Circuit Judge Ronald J.P...
...Nearly all suffered life-threatening forms of the infections known as pelvic inflammatory disease (PID...
...In 1974, increasing and alarming numbers of Shield-related spontaneous septic abortions became known to the FDA, and the agency asked Robins to suspend Shield sales in the United States...
...it brings us great good...
...In the words of Miles W. Lord, who retired recently as Chief District Judge for Minnesota, they are wearing "a deadly depth charge in their wombs, ready to explode at any time...
...From the start, her misfortune was compounded by physicians whose incompetent diagnoses, such as that she was experiencing a nervous breakdown, destroyed her chances for a full and swift recovery...
...I have never thought of it as life-threatening...
...The murder charges, brought by Cook County prosecutors, were said to be the first in a work-related death...
...Did he have "any curiosity" about why the company, a few months before, had paid $4.6 million, mostly in punitive damages, to settle seven Shield lawsuits...
...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...
...But even in today's political climate, growing numbers of Americans have awakened to the paradox...
...Mample now lives in Boise, Idaho...
...You know, charges such as reckless disregard of truth, fraud...
...Certainly the response to Robins's own call-back campaign of October 1984 suggests the higher figures are closer to the mark...
...Although the sum is secret, it was well above an initial offer by Robins to settle for $1.4 million...
...Judge Lord saw the absurdity of condemning what a man did in a bedroom but not in a boardroom when he said: "We still haven't grasped that the man who assaults women from an office chair is as grave a sinner as the man who assaults a woman in an alley...
...The jury awarded $125,000 to Mrs...
...coal companies have falsified records showing the exposure of miners to the particles that cause black lung disease...
...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...
...I have heard that," he added...
...Actually, according to trial testimony by Dr...
...An estimated 60 per cent of the U.S...
...Since 1978, when he became senior vice president for research and development, Lunsford has been in charge of the company's medical department and thus the highest-ranking executive with specific jurisdiction over the Shield's safety...
...Worldwide, the seriously injured victims of the Dalkon Shield could number in the tens of thousands...
...he did not properly treat the infection and intimated that she had gotten it because of a promiscuous life style...
...Robins sent her pretrial interrogatories, but did not move to take her deposition...
...Robins executives insist All the deterrents and restraints that normally govern our lives-religion, conscience, criminal codes, economic competition, press exposure, social ostracism-have been overwhelmed that they did not know of any special hazard...
...Please, in the name of humanity, lift your eyes above the bottom line...
...This will not be done by weakening or eliminating existing deterrents and restraints, such as Federal regulators...
...behaved ruthlessly toward victims who sued, and hired outside experts who would give accommodating testimony...
...Like, yes, Your Honor, ladies and gentlemen of the jury, are you going to give me a boy child and a girl child?' probably only hundreds, still used it...
...Maybe I should, but I don't know that," he swore...
...Please, gentlemen, give consideration to tracing down the victims and sparing them the agony that will surely be theirs...
...Some of these women had elective abortions...
...I just experienced so many emotions—the anger, the shock, of knowing what large corporations, what this corporation, did to my child...
...After the operation her condition improved for a time, only to deteriorate again...
...She began having dangerous, extremely painful, and recurring pelvic infections...
...Mary was first fitted with a Shield when she was eighteen...
...You certainly knew, when you started marketing this device, that pelvic inflammatory disease was a life-threatening disease, did you not...
...The Shield created a disaster of global proportions because a few men with little on their minds except the pursuit of megabucks made decisions, in the interest of profit, that exposed millions of women to serious Morton Mint: is on the business news staff of The Washington Post...
...Maybe for that I would have waited for trial...
...It did so on June 28, 1974...
...Robins contended, however, that no campaign was needed, because the Shield was no more hazardous than rival IUDs...
...Losing the ability to choose whether I wanted a family—that was the hardest thing for me to get over...
...She took antibiotics orally and was cared for by her sister, who flew in from the Midwest, and her mother, who came from Maryland...
...So I went back to the University of California at Los Angeles Medical Center, where a doctor recommended me to...
...Not only was the Shield unsafe, it was surprisingly ineffective...
...makers of infant formula have, in impoverished Third World countries, deprived babies of breast milk, the nearly perfect food...
...As it stands now, it often provides the illusion, but not the substance, of adequate protection...
...This led her to consult a lawyer and, shortly after, to sue Robins...
...The exact number of women still wearing the Shield is unknown...
...Corporations too often act without compassion and, no matter what damage they cause, without remorse...
...assigned a lower value to foreign lives than to American lives...
...They told me that Robins initially resisted their demands for data on such children, but finally confirmed the number...
...Charles M. March, the chief gynecologist, in a letter to the company, "she expired on the eighteenth postoperative day...
...But they did know, and they chose to do nothing—until it was much too late...
...Not so long as the likes of George Bush may succeed him...
...To try to control the infection to prevent it from spilling into the abdominal cavity, Dr...
...In 1975, a year after the suspension of Shield sales here, Martina Langley was a volunteer at a family-planning clinic in El Salvador...
...For the uncompensated victims, this may be yet another blow because, critics fear, reorganization could let the company put them at the end of a line of lenders, suppliers, and other creditors...
...In February 1982, Mary settled out of court...
...Please, in the name of humanity, lift your eyes above the bottom line...
...Hamrell put me in Santa Monica Hospital for serious intravenous antibiotic therapy, by which I mean that three different antibiotics were pumped into me, one each hour...
...She is still enraged when speaking about the company...
...Surely the time has come to extend the definition of immoral conduct into the boardroom and the corporate office...
...Then, she said, the doctor would motion toward her and tell the woman, "She is from the United States and people [there] use it...
...Yet almost every other major drug company has done one or more of these things, some have done them repeatedly or routinely, and some still continue to do so...
...M.M...
...The need today is to stop the individuals who run corporations from inflicting harm...
...concealed hazards from consumers, the medical profession, and government...
...To be sure, the same pursuit finally led Robins, in August 1985, to seek reorganization under Chapter 11 of the Bankruptcy Code...
...Such prosecutions must proliferate, and state officeholders and candidates must make passage of tougher laws an issue...
...Mary filed suit against Robins in November 1979...
...Mary Beth Kornhauser, a screenwriter in West Hollywood, California, was thirty-one when I interviewed her last December...
...In December 1983, Town and Country magazine listed him among the top five of "The Most Generous Americans...
...Two weeks later, Hamrell had to operate...
...After seven terrible years of misdiagnosis and illness she was finally deprived of her ability to bear a child...
...Like, yes, Your Honor, ladies and gentlemen of the jury, are you going to give me a boy child and a girl child...
...The exaggerated and bogus claim led women to reject more effective birth control in favor of the Shield, and this led directly to consequences far worse than unwanted pregnancies...
...the second, in April 1983, was Eugenie Standeford, thirty-four, of New Orleans...
...That there was a conspiracy by Robins executives to hide the truth is what got me...
...They showed that childless IUD wearers who have had PID run a far higher risk of infertility if their devices were Shields than if they were other makes...
...Mample, but nothing to Melissa, holding that a causal relation had not been established between the Shield and her preThe paradox by which immersion in the corporation washes away personal responsibility is perfectly captured in the figure of E. Claiborne Robins, builder and chairman of the Fortune 500 company that bears his name...
...A human being who would not harm you on an individual face-to-face basis, who is charitable, civic-minded, loving, and devout, will wound or kill you from behind the corporate veil...
...But the real truth was that what they did was criminal, and that criminal charges should have been brought against the persons responsible...
...Other qualified observers, however, were estimating the figure to be much higher, anywhere from 80,000 to more than half a million...
...And not so long as Americans remain content to live with the paradoxical proposition that harm knowingly and willfully inflicted on them is to be punished, even by death, if done for personal reasons, but is to be unpunished, not even by a day in jail, if done for corporate reasons...
...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...
...I went to a doctor, and he gave me oral antibiotics, which didn't work...
...our hopes lie in strengthening them and adding new ones...
...At the time, the medical profession was divided as to the wisdom of removing an IUD from a pregnant woman, and her obstetrician was among the physicians who believed the odds were Host Generous American fifty-fifty that removal of the Shield would induce a miscarriage...
...Larson drew similar answers from Carl Lunsford...
...A lot of things had been blown apart by the hysterectomy...
...Peggy Mample's lawyers, Jane I. Fantel and John J. Davids, argued to the jury that the cerebral palsy was the ultimate result of Robins's false effectiveness claims, of its failure to do studies on the Shield's potential to cause premature births, and of its related failure to investigate the consequences of such births...
...The diagnosis was a pelvic abscess...
...Even worse, they cannot be held accountable, as people can be...
...Needless to say, I don't buy Robins's products any more...
...I am not suggesting that we should abandon Government regulation, but only that we must recognize its limitations...
...She was nineteen when she had Melissa, who has cerebral palsy and will be in a wheelchair for life...
...If this were a case in equity, I would order that your company make an effort to locate each and every person who still wears this device and recall your product...
...Nor does the Shield catastrophe teach us that the pharmaceutical industry is unique...
...military contractors have supplied defective weapons to the armed services...
...Melissa is very intelligent," she told me...
...they know that the proposition is fraudulent...
...The reality of seeing this in print, it was staggering...
...I had already waited two years for the setting of a trial date...
...I had had enough pain caused by them...
...It was February 15, 1979—one day less than seven years after her Dalkon Shield had been inserted...
...Peggy J. Mample, thirty-two years old when I interviewed her in February, is one of several hundred mothers who conceived while wearing a Dalkon Shield and gave birth prematurely, in the third trimester, to a child with a grave birth defect...
...The Robins Company, which had made no studies at that time of the IUD's potential to induce premature births or of the possible consequences of such births, was making a soothing promotional claim that it would abandon two years later...
...I don't know that," Robins testified...
...Four years later, a sequence of deaths began to be reported among long-time Shield users who were not pregnant...
...It is reasonable to suggest that Eugenie Standeford, Christa Berlin, and other women might not have died, and that thousands of other women would not have suffered pain and agony, if Robins had acted earlier...
...vere damage to their reproductive systems...
...Upon receiving no response, Post sent a second letter...
...I am not sure where...
...The obstetrician's advice was to leave the Shield in place and go to term, and Peggy agreed...
...The FDA never acted on a petition filed by the National Women's Health Network in April 1983 for a recall, to be paid for by Robins, to ensure retrieval of the Shield "from all women who currently wear it" and for imposition of criminal penalties...
...She found herself unable to bear the prospect of litigating for two to five more years, "never able to put the pain behind me, wondering when I would have to completely relive the experience in a trial situation...
...Not that the A.H...
...Richard P. Dickey, a former member of the Food and Drug Administration's obstetrical and gynecological devices advisory panel, has seen first-hand the conditions faced by a woman who suffers PID...
...A Baptist, Robins was nominated by the Richmond chapter of B'nai B'rith International for the Jewish service organization's Great American Tradition Award...
...Charles E. Hamrell in Santa Monica, and he immediately put me in the hospital...
...In June 1984, when Melissa was almost twelve, a second jury returned a verdict for her...
...Sometimes the doctor would say to the patient, This is from the United States and it's very good,' " Langley told David Phelps, a Washington correspondent for the Minneapolis Star and Tribune...
...Mample then filed a new lawsuit for damages for Melissa...
...In October 1984, six months after she died, Robins finally announced a recall campaign...
...No, the lesson of the Dalkon Shield catastrophe is not that Robins alone behaved in an immoral or unexpected fashion, but that, first, the corporate structure itself— oriented as it is toward profit and away from liability—is a standing invitation to such conduct...
...In its essentials, her story is similar to that of countless other women whose quest for safe and effective birth control led them to trust their physicians, who in turn trusted the manufacturer...
...Abroad, Robins distributed about 1.71 million Shields, and in June 1974 it estimated that 800,000 to one million were implanted...
...assorted industries have dumped poisonous wastes into the environment...
...I just think it's absolutely incredible that a large corporation can do this to the American public, using us as guinea pigs," she says...
...Carl Lunsford, the senior vice president, and William A. Forrest Jr., the vice president and general counsel: "The only conceivable reasons you have not recalled this product are that it would hurt your balance sheet and alert women who already have been harmed that you may be liable for their injuries...
...The answer was "no...
...At the same time, Mary said she did not want to go to trial...
...After eight days in the hospital, Mary returned to her apartment, sensing that she was only having a reprieve: Hamrell had prepared her for the possibility of a radical hysterectomy...
...Most of the infections impaired or destroyed the women's ability to bear children...
...Yes, Robins knowingly and willfully put corporate greed before human welfare...
...When her lawyer, John T. Baker, prepared a "statement of facts," she said, "it read like Watergate, except that this was my life...
...She learned she was pregnant in February 1972...
...They have become aware, in part through the repercussions of the Shield disaster, of the impossibility of reconciling personal responsibility with corporate immunity...
...I must therefore resort to moral persuasion and a personal appeal to each of you...
...Society at large accepts and, if only by its silence, validates such compartmentalization...
...In February 1977, extremely few of the more than 800,000 American women believed to be wearing the Shield had the faintest notion that the devices were becoming more hazardous with each passing day...
...Only last summer in Illinois, three former executives of Film Recovery Systems, Inc., in Elk Grove Village were successfully prosecuted for murdering a sixty-one-year-old Polish immigrant who had inhaled cyanide used to recover silver from used X-ray film...
...He is a chemist whose involvements with the Shield date back to the premarketing year of 1970...
...The press and clergy, too, will have to take the stand that a person's criminal and immoral conduct is criminal, period, and that no ethical counterargument exists...
...And too often the law fails to look behind the corporate veil, to prosecute the individuals who make decisions and act in the name of the corporation...
...I wanted to heal myself and I knew I couldn't if I had to dredge everything up...
...The story of the Dalkon Shield lays bare the perils inherent in contemporary business practices and in corporate law, in a system that allows corporations to profit even if they put human beings at risk...
...I was very infected with tubo-ovarian abscesses, one the size of a grapefruit, one the size of an orange...
...By early 1983, some FDA officials and gynecologists were confident that few American women, 'Money's fine, but were they going to give me my ovaries back...
...What does the Dalkon Shield catastrophe teach us...
...it was an intensely painful period in my life...
...He had not "personally reviewed" any studies of the Shield's safety or effectiveness in preventing conception...
...He pointed out that Berlin had worn a Shield for many years...
...More cheerless news came last April from two studies funded by the National Institutes of Health...
...Even women who have had the Shield removed are not out of danger...
...In the face of several thousand settlements, multimillion-dollar court awards of punitive damages, and its own Shield removal campaign, the claims of innocent ignorance seem incredible, but persist...
...As the public mood becomes more receptive to efforts to hold individuals accountable for corporate actions, we can expect prosecutors, governors, and legislators in many states to make such efforts, and to earn public approval for doing so...
...Despite intensive care and cardiorespiratory support," said Dr...
...The first, in November 1981, was a Los Angeles woman...
...Eighteen days after Judge Lord's appeal, Christa Berlin, forty-one, was admitted to the Los Angeles County-University of Southern California Medical Center with lower abdominal pain and fever...
...Not so long as Congress allows special interests to control election financing...
...infection, sterility, and even death...
...Money's fine, but were they going to give me my ovaries back...
...Because PID is commonly not an affliction that is simply treated and is then over and done with, large numbers of Dalkon Shield wearers suffer chronic pain and illness, sometimes requiring repeated hospitalization and surgery...
...He asked that Robins mail a corrective "Dear Doctor" letter, partly to urge "immediate removal of devices in use...
...By the count of the Food and Drug Administration (FDA), 248 women, just in this country, endured this dangerous, Shield-related complication...
...Many have waged desperate battles to bear children despite se...
...The claims were flowing in at the dramatic rate of more than 100 a week...
...For fifteen of them, these septic abortions were fatal...
...Robins Company began to sell the Dalkon Shield, promoting it as the "modern, superior," "second generation," and, most important, "safe" intrauterine device for birth control...
...She then gave birth prematurely to Melissa on July 22, 1972...
...He wrote that he had just learned of deaths of two young women, that the circumstances were clearly causally related to their Shields, and that he was concerned about how many more fatalities and serious injuries would have to occur before Robins would take preventive action...
...As the fetus grew, Robins claimed, the Dalkon Shield would be "pushed gently aside" and no harm would befall either the fetus or the mother...
...The number of wearers who became pregnant with the devices in place was on the order of 110,000, or 5 per cent, 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...
...Not even women who still wear the Shield with no apparent problem are safe: They run the risk of suddenly being stricken by life-threatening PID...
...They went right to trying to settle, because, I believe, I had a strong case," she said...
...It manages our great endeavors...
...Thus, despite evidence produced by trial lawyers that rotting tail strings put large numbers of women at risk, the Food and Drug Administration did nothing to protect Shield wearers for nine years, from the time the Shield went off the market in 1974 until 1983, when a study by the Centers for Disease Control incriminated the device...
...On April 19, 1981, when she was living in Seattle, the CBS investigative news program "60 Minutes" included a scorching segment on "the disaster of the Dalkon Shield...
...Did he know it could destroy fertility...
...Government provides insufficient and erratic protection, in part because it is subject to political pressure from both Congress and the corporations themselves, and in part because of the lethargy of entrenched bureaucracy...
...Modern society cannot function without the large organization...
...An infected Shield wearer "where there are no doctors, no antibiotics, she's going to die," he told me...
...Knowingly and willfully, automobile manufacturers have sold cars that would become rolling incinerators in rear-end collisions...
...It's absolutely incredible that the American public puts up with it, that they don't do something about it...
...Not so long as Ronald Reagan is President...
...second, the global scale of contemporary marketing has made hazardous corporate activities more perilous to ever larger numbers of people, and, third, all the deterrents and restraints that normally govern our lives—religion, conscience, criminal codes, economic competition, press exposure, social ostracism-have been overwhelmed...
...Figures are simply unavailable from most of the countries where the Shield was used...
...This article is adapted from his book, "At Any Cost: Corporate Greed, Women, and the Dalkon Shield," to be published in November by Pantheon...
...Here is her description of the events directly preceding the "total hysterectomy" she suffered at age twenty-five: "In 1978,1 started getting sick cramps, vomiting, high fever, the same spells that had come up periodically...
...David A. Eschenbach of the University of Washington, an expert on the adverse effects of IUDs, the total number of such children in the United States was 200 to 300...
...Your example will cast its shadows into eternity, as the sands of time carry the indelible footprints of your good works...
...At home, the child moves about by crawling, but she attends regular classes in a public elementary school...
...Cigarette companies profit from smoking, the single greatest cause of preventable disease and death...
...by the end of March, 4,437 women had filed claims for Shield removals...
...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...
...I had lost ten pounds in two days...
...I was apparently about ready to explode...
...A towering presence in American philanthropy, he has given away truly astonishing sums in gifts to a broad array of worthy causes...
...She had no basis for implicating the Shield until almost nine years later...
...At the presentation banquet in June 1982, E. Bruce Heil-man, president of the University of Richmond, was the principal speaker...
...At a series of depositions taken in 1984 by plaintiffs' lawyer Dale Larson, E. Claiborne Robins swore that he was unable to recall ever having discussed the Shield with his son, E. Claiborne Robins Jr., the company's chief executive officer and president...
...Antibiotics in high doses were injected into her, but her condition worsened, requiring drastic surgery including a hysterectomy...
...There followed a catastrophe without precedent in the annals of medicine and law...
...They took away the right of someone to decide to have children...
...Larson asked...
...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 telephone calls on toll-free hotlines...
...Robins Company was a renegade in the pharmaceutical industry...
...The problem at the core of such conduct is not simply that corporations have no conscience, but that they are endowed by law with rights beyond those allowed to individuals...
...You are the corporate conscience...
...He had not tried to find out how many users died...
...In October 1972, one physician pronounced her seriously infected and removed her Shield...
...Her only disability is that she can't walk...
...But Bradley Post, a leading plaintiffs lawyer, did know of the danger, and so he wrote a letter to the company...
...In the United States alone, PID killed at least eighteen women who had been wearing Shields...
...Truly the Lord has chosen you as one of His most essential instruments," he told Robins...
...We applaud you for the high accomplishment of always exhibiting a steadfast and devoted concern for your fellow man...
...chemical companies have sold abroad carcinogenic pesticides that are banned here...
...No response came to this plea, either...
...Please, gentlemen, give consideration to tracing down the victims and sparing them the agony that will surely be theirs' mature birth and cerebral palsy...
...I was not emotionally stable because of it and its ramifications...
...In 1969, he gave $50 million to the University of Richmond, an unrestricted gift said by the university to have been the largest by a living person ever made to an institution of higher education...
...Ten months later, on February 29, 1984, Judge Lord pleaded for a recall in an instantly famous courtroom reprimand to three senior company officers...
...Copyright © 1985 by Morton Mintz...
...suppressed scientific studies that would ascertain safety and effectiveness...
...Banks sentenced the executives to twenty-five years in prison and $10,000 fines...
...The fact that Americans, especially in pharmaceutical companies, would so knowingly ravage women, and get away with it, was staggering...
...Cashing in At Any Cost Corporate Greed, Women, and the Dalkon Shield BY MORTON MINTZ In January 1971, the A.H...
...You'd think that when people deal in pharmaceutical medicine, they'd be honorable people...
...Peggy Mample is also among the hundreds of mothers who were themselves physically unharmed, or not seriously harmed, by the Shield while, unknown to them, it attacked their unborn children...
...But Robins consistently claimed—and continues to claim—that the Dalkon Shield was safe and effective when "properly used...
...He may do this without qualm because he has been conditioned to drop a curtain between his private moral and religious self and his corporate immoral and irreligious self...
...Today, more than a decade after Shield sales officially ended in the United States, its legacies of death, disease, injury, and pain persist...
...Now a lawyer in Austin, Texas, she recalls that the only IUD the clinic's doctors were inserting was the Shield, and that some clinics in El Salvador continued to implant Shields until 1980...
...Since then, Robins and his family have given at least $50 million more to the university and to various other causes...
...women who conceived with Shields in place lost their unborn, or about 10,000 more than would have done so had they been wearing other IUDs...
...You cannot lock up a corporation, or sentence it to hard labor or to the electric chair...
...It's worse than abortion...
...Checking around the country before and during the trial, Fantel and Davids found thirty more children of Shield wearers who had been born prematurely in the third trimester with major congenital defects...
...He told E. Claiborne Robins Jr., the company's chief executive officer...
...My guess is that Shield-related PID killed hundreds—possibly thousands—of women outside of the United States...
...A friend who saw the television program called to tell her about it and to ask if the IUD she had worn was a Shield...
...But this court does not have the power to do so...
...The anger of the Shield's victims has been fueled by Robins's consistent stonewalling and professions of innocence and ignorance...
...Others suffered the previously rare miscarriages called spontaneous abortions...
...Lunsford swore he recalled no "expressions of concern" by any company official about PID, and did not remember having "personally wondered" about the toll it was taking...
...Others, in the fourth to sixth months of pregnancy, experienced the still rarer infected miscarriages, or septic spontaneous abortions...
...For the foreseeable future, there is no prospect of enacting legislation embodying the powerful moral command in Leviticus 19:16: "Neither shalt thou stand idly by the blood of thy neighbor...
Vol. 49 • November 1985 • No. 11
