IUD Controversy Begets Volumes

Certainly it has the makings of a good scandal: rampant corporate avarice, a sluggish federal regulatory agency, demonic central characters who falsified or misrepresented key data and legions of victims who span the globe--victims who are either dead, brutally scarred or permanently unable to bear children. In the person of U.S. District Judge Miles Lord of Minnesota, the tragic tale of the Dalkon Shield even has a home-grown hero, filled with a suitable complement of fire, brimstone and vociferous moral indignation.

But the story is definitely not new. The Dalkon Shield has not been marketed in this country for more than 10 years. And for all its elements of corporate shenanigans, it is as much as anything a women’s health story.

In the world of publishing, these two qualities are often tantamount to a giant kiss of death.

True, the horrifying details continue to emerge, and the recent announcement by Dalkon Shield manufacturer A.H. Robins that this pharmaceutical giant intended to file for protection under Chapter 11 of the U.S. Bankruptcy Code blasted the story back into headlines that began in 1974 when Robins withdrew from the market a contraceptive device that had been inserted in more than 3 million women. Though Robins continues to maintain that “used properly,” the Dalkon Shield is no more hazardous than any other intrauterine device, the crab-shaped object has been at the center of a storm encompassing medicine, law, corporate practices and women who chose this IUD in an attempt to prevent unwanted pregnancies.

Newspaper profiles and last season’s widely viewed “60 Minutes” segment on Judge Lord brought renewed attention to the case of the Dalkon Shield. Settlements by Robins of a reported $343 million on 8,750 Dalkon Shield cases suggested it was a matter the courts were taking very, very seriously indeed.

Still, the appearance within two months this fall of three books dealing with the Dalkon Shield was seen as a definite head-turner, even by some of those closest to the three quite different individual projects.

“I don’t remember anything like this, especially where the people involved have not, with the exception of Judge Lord, been public figures,” said Alexia Dorszynski, editor at Macmillan of “Night mare: Women and the Dalkon Shield” by wife-and-husband team Susan Perry and Jim Dawson of Minneapolis.

Added Dorszynski of the trio of books appearing this same literary season, “I think that three’s a lot, that’s for sure.”

But as Belle Blanchard Newton of Doubleday, publisher of “Lord’s Justice,” by Sheldon Englemayer and Robert Wagman, pointed out, “The dimensions of the issue are such that it leads to this kind of inquiry. I don’t think it’s unusual when you have an issue of these proportions for people, and especially writers, to take this kind of interest in it.”

Among the five writers of these three books, that interest was manifested in distinctly different approaches to essentially the same subject. In “At Any Cost: Corporate Greed, Women and the Dalkon Shield” (due out in November from Pantheon) veteran Washington Post investigative reporter Morton Mintz said he chose to concentrate on “the corporation and corporate conduct.” For Perry and Dawson, said Perry, “all along, our entire concern throughout the book was the women and how they had been misused.” And as far back as six years ago, Sheldon Englemayer said, he and his partner Wagman came across the outspoken Judge Lord and decided that “one day, we would do a book on Miles Lord.” With his now legendary courtroom denunciation of Robins in January, 1984, said Englemayer, “Lord put the spotlight on a story that should have been spotlighted going back to 1974.”

‘The Birth Control Savior’

Or earlier, in the view of Susan Perry. A former Time-Life writer now free-lancing and married to an investigative reporter for the Minneapolis Star and Tribune, Perry traces the Dalkon Shield saga back to the early ‘70s, “when there was the big birth control pill scare, and the IUD was going to be the birth control savior.” Data on these new intrauterine devices was scarce, and, as has subsequently been demonstrated through the mountain of Dalkon Shield depositions, often incomplete.

Perry still bristles that young women who chose any IUD, much less the Dalkon Shield, as birth control, have since been bombarded with the “you should have known better” line of argument. “It really angers me,” she said. “They were young, many of them--19, 20, 21. I think the better question is why didn’t their doctors know better?”

In writing the book, said Perry, “I wanted them to see that it wasn’t their fault. I wanted to reach those women who were wearing the Dalkon Shield, many of whom were not aware of what was behind all their pain and suffering. Many of them have never understood completely how they were wronged.”

Agreed Dawson, “If you had had men dying and coming up sterile, it would have been national news in 1974.”

“I think it’s a feminist book,” said Perry, “but I didn’t want it to be strident. I think the story speaks for itself.”

While focusing in large part on the individual stories of women who wore a device later linked to serious pelvic inflammatory infections, sterility and even death, “We really didn’t want to write a polemic book,” Dawson said. “We’re journalists, and this is a fairly outrageous story--it’s outrageous on a general products liability level, and it’s outrageous because this clearly happened because these people were women. It just seems to me a real good story, and we did try to be as straightforward as we could.”

‘The Ultimate Expert’

Growing up in the area of Washington, Perry and Dawson cut their journalistic teeth on the writings of Washington Post reporter Morton Mintz. “He was sort of both of our idol when we were growing up,” Dawson said. On the subject of the Dalkon Shield, Dawson called Mintz “sort of the ultimate expert. I mean, he’s covered it since the beginning.”

But it wasn’t until 1982 that Mintz began contemplating a book on the subject. Then, preparing a series of articles on the Dalkon Shield episode for The Post, “I saw in this story the opportunity to tell from beginning to end, with documentation unequalled in any other case except perhaps asbestos, the story of corporate conduct and corporate greed.”

Reviewing “information that had been developed starting in 1974, 1975,” Mintz also monitored events in the Dalkon Shield case that continued to unfold. “Every time I thought it was settling down,” he said, “there would be some new convulsion, particularly those that began with Judge Lord’s entrance into the case.”

For all his years of covering health and the medical establishment, Mintz found himself appalled by government inaction in the Dalkon Shield case. “It has to be pointed out,” Mintz said, “that the FDA, after 1974, when the device was withdrawn from sale, effectively did nothing for nine years, until 1983, when the CDC (Centers for Disease Control) study came out.

“Meanwhile,” said Mintz, “trial lawyers had been digging out all this evidence of increasing risk of women still wearing the damned thing.”

Mintz was stunned, too, by the stories he heard over and over from women he interviewed--and from women in his own Washington Post newsroom--of medical indifference to the pain they had experienced as a result of the Dalkon Shield. “I’m 63, and no doctor has ever suggested to me that a pain of mine might be psychosomatic,” Mintz said. “It came as a shock to me that this would actually happen, that acute pain would be dismissed this casually.”

But Mintz in no way saw the Dalkon Shield experience as a women’s story: In fact, he fairly bristles at the term. “I didn’t see it primarily as a women’s story at all,” he said. “What Robins did in this case was an example of the kind of corporate conduct that we have all too much of.

“The victims could have been men, it made no difference. But you see, if you get beneath that, what Robins saw was an opportunity to tap a huge market with an unregulated product. They had no interest in going into the birth control drug business. Drugs are regulated. Devices are not.

“Of course women were victims,” Mintz said, “and of course it’s a women’s story. But at bottom it’s a story of corporate conduct and of the ineffectiveness of all the restraints that society supposedly has in place to stop it.”

For seven years the editor of nationally syndicated columnist Jack Anderson, Sheldon Englemayer said that he, too, had long been caught up in the field of health, and particularly in the sphere of health fraud. “One day” he dreamed of writing “this big book” on the Food and Drug Administration. Instead, he and partner Wagman, collaborators on seven books over the last 13 years, turned their attention first to asbestos, and later, to the pivotal role of Miles Lord in the Dalkon Shield case. If Dawson and Perry laud Lord as “a true American hero,” and if Mintz agrees that Lord was “the catalyst for a great deal in this case, a great deal of pressure on the company certainly,” Englemayer goes so far as to say that “Lord had the greatest impact on the Dalkon Shield case.”

A Lecture From the Bench

Lord, after all, scandalized much of his own legal community when he lectured three A.H. Robins executives from the bench.

Sniffs Englemayer: “It takes guts to be willing to say exactly what you believe. Very few people have that kind of intestinal fortitude. I wish Lord had gone ahead with his threats of earlier years to run for public office.”

Like Mintz, Englemayer balks at viewing the Dalkon Shield episode as primarily a women’s story. “There are two main issues here,” he maintains, “and neither has anything to do with women.”

First, said Englemayer, “the question is what is the role of a judge where justice is concerned?” Second, “when is this country going to learn that we are a great capitalist system--that there really cannot be a price tag on human life?”

In terms especially of health and corporate transactions, “we’ve got to stop this benefit-to-risk ratio.”

Fuming about Robins’ recent attempt to seek the protection of Chapter 11 of the U.S. Bankruptcy Code, Englemayer points out that Robins is the same company that makes ChapStick, Robitussin cough suppressants and Sergeant’s pet products, among other things. “This company is not bankrupt,” Englemayer said. “I think the bankruptcy action is a fraud. Certainly in the legal sense it’s a fraud, but also in the moral sense it’s a total fraud.”

Whether all three books can prosper in the current literary market is anybody’s guess. Susan Perry contends that “I think it’s great that there are three books out on the Dalkon Shield. I want all the women out there to hear the story. Not just the women who wore the Dalkon Shield, but all the women who used IUDs, all the women who use birth control at all.”

Meanwhile, at the National Women’s Health Network, an organization that appealed repeatedly to the FDA to take action on the Dalkon Shield matter, attorney and immediate past president Sybil Shainwald hailed the emergence of the three new Dalkon Shield books.

But, said Shainwald, “it’s just too bad that it took until 1985 to get the books out.”