10/02/95 Informed Consent

Informed Consent

(Cover Story conclusion)
ONE MORNING IN LATE 1990--some 15 years into her ordeal--Colleen got a call from her daughter, who now lived in California. ``Mom,'' Kathy said, ``I think I know what's wrong with you. I just saw this woman on television out here. She has all of your symptoms, and she has Dow Corning implants.'' Listening, Colleen felt a great weight lift. At last, she had an explanation for her suffering.
So, after a long day of meetings and memos, John came home to hear Colleen accuse his company of selling an unsafe product that caused her illnesses. The accusation felt like a punch to the gut.
If implants really did cause such problems, he thought, the company could not have known. For that matter, he was skeptical that silicone--which he was always told was biologically inert--had hurt her. If she was right, he told her, ``our lives will be turned upside down.''
``That may be,'' she countered, ``but I can tell you right now they're coming out. All I care about is living.''
The two stayed up nearly all night, discussing what they should do. How would they find a doctor they could trust? Midland was a gossipy town. Even a cursory discussion of problems with implants might get back to his colleagues. Besides, John still doubted the company was selling a harmful product. ``There was no rational or documentable reason to believe it,'' he says. ``Intellectually, I knew where she was coming from: The pains were real--not in her head! But there were all the other, nonemotional factors that played in it, too. We had built a good life in Midland and now suddenly all of it--friends, career--was at stake.''
That night, Colleen wasn't all that concerned about John's career, or their friends, or their life in the close-knit community that sometimes felt like a subdivision of Dow Corning. She knew John felt torn between loyalty to her and loyalty to the company. ``Plus, he's the one who took me to get it done....That night was terrible. It was as if our life changed overnight. But I knew one thing for sure: I just wanted them out and I wanted to get well.''
In the weeks ahead, John felt engulfed. At work, he would listen as people around him decried the FDA's idiotic bureaucrats and the media's sensationalists and dismissed, often cruelly, the complaints of women with implants. At home, he would listen to Colleen, who now believed that Dow Corning had denied her the right of informed consent by hiding the risks of having implants. Back at work the next day, he'd hear the other side--that the company was the victim of overzealous regulators and consumer advocates.
On June 28, 1991, Colleen underwent the operation to remove her implants. Afterward, her surgeon told her that her left implant had been ruptured for some time and the other was leaking silicone.

THE SAME MONTH, SWANSON READ A STORY IN BUSINESS WEEK that pushed him over the edge. Correspondent Tim Smart cited evidence that the industry had known for at least a decade of animal studies linking implants to cancer and other illnesses. He wrote that implant makers, ``especially Dow Corning,'' were meeting safety questions and lawsuits ``with a full-court press to keep their internal memos and studies from reaching the public.'' Swanson found this public questioning of the company's ethics devastating.
He immediately drafted an E-mail note to the executive then chairing the Business Conduct Committee, urging that Dow Corning reexamine its stance. ``Some 20 years ago,'' he wrote, ``Dow Chemical's intransigence about napalm gave that company a public image that took hundreds of millions of dollars and a total change in attitude to reverse. It's a lesson worth studying.''
Then he began approaching colleagues to argue for suspending the production and sale of implants until the company could answer all charges. No one agreed. To others, this was about business, not ethics. Since virtually everyone in the company thought silicone was safe, it didn't make economic sense to withdraw the product. But Swanson thought the company's position was misguided even in terms of business strategy. Its strident, defensive attitude was putting its image at risk.
He went to J. Kermit Campbell, a group vice-president whom CEO Lawrence Reed had designated to manage the crisis, and recommended that a statement be prepared for consideration at an upcoming board meeting. He then wrote a news release announcing that Dow Corning would stop producing implants. Campbell took the release to the meeting but didn't fight for it, sources say. The directors were swayed by arguments that suspending operations might hurt the company in court. Besides, Dow Corning was about to deliver tens of thousands of pages of studies and other data requested by the FDA to prove that implants were safe.
In July, 1991, Dow Corning shipped several cardboard boxes stuffed with documents to the agency. Little more than a month later, an FDA official denounced the clinical studies as ``so weak that they cannot provide a reasonable assurance of the safety and effectiveness of these devices.''

ON SEPT. 18, 1991, SWANSON INFORMED CAMPBELL that he wanted to recuse himself from any work connected with implants. For months, he had brooded about this decision. Would he lose his job? Become a pariah? But he could no longer live with the secret that his wife was suffering from silicone-related disease. And he could no longer accept the decision to keep selling implants.
Of course, he could have quit in protest or gone public. But he had none of the memos or safety tests that had hurt the company in court--and then been hidden by court seal. He had no scientific evidence that silicone was unsafe. Even Colleen's doctors, who had treated hundreds of women
with implants, lacked proof. There were no long-term epidemiological studies. What's more, Colleen's medical bills were averaging $50,000 or more a year. John was just two years from retirement--and he loved Dow Corning. Colleen said she'd support whatever decision he made. ``I didn't think he should quit,'' she says, ``because it would prove nothing, and neither John nor I had done anything wrong.''
Swanson described to Campbell Colleen's long decline and what they believed was the cause. He then asked to be recused, and Campbell agreed. Swanson felt that one burden had been lifted.

LESSTHANTHREE months later, a California woman won a $7.3 million judgment against Dow Corning that would be upheld on appeal. Soon after, internal documents that had surfaced in the trial were leaked to FDA Commissioner David Kessler. The papers raised significant doubts about the safety of silicone implants.
On Jan. 6, 1992, Kessler called for a 45-day moratorium on sales of the implants. Soon after, Dow Corning's board began seeking successors to Ludington and Reed, neither of whom seemed capable of leading the company through the crisis. They chose Keith R. McKennon, a Dow Chemical executive vice-president who had earned the sobriquet ``the fireman'' for his ability to extinguish blazes of bad publicity.
On Feb. 10, McKennon became chairman and CEO. In March, he took Dow Corning out of the implant business. On Apr. 16, Kessler banned silicone breast implants for most women because manufacturers had not proven the devices were safe and effective.

SIX MONTHS BEFORE HER IMPLANTS WERE REmoved, Colleen had decided to sue Dow Corning. John would not be a party to the suit nor even speak with her attorney. In January, 1991, her lawyer approached the legal department about a settlement but was rebuffed. Colleen finally sued in August, 1992, a year after her surgery. Even then, she dreaded seeing a headline about her suit, so she insisted it be filed late on a Friday.
Three months later, McKennon summoned Swanson to his office. Seeming tense and ill at ease, he told Swanson he had recently learned of Colleen's lawsuit and wished he had known about it earlier. There had been no need for a suit, he said. The company could have handled it another way.
Swanson told McKennon how the legal department had turned away Colleen's attorney. McKennon, who declined to be interviewed, clearly knew he faced a public-relations disaster if word got out. ``I had never seen him this angry,'' says Swanson. ``He was mad, first at me, and then, I suppose, at the legal department.''
``Look,'' McKennon demanded, ``what does Colleen want out of this? Does she want a zillion dollars? This could be messy. Can't we just talk this out and see if we can get it resolved?'' But the more the men talked, the clearer it became that they were resolving nothing.

THOUGH HE HAD NO MORE TO DO WITH IMPLANTS at work, Swanson was consumed with them at home. He devoured any information he could find, searching for help for Colleen--and explanations for his company's behavior. He had already announced he would retire as soon as he was eligible--in August of 1993. ``It was hard to put on a good face to go to work, and yet I had to do this,'' he says. ``I did not want to appear negative or arrogant or belligerent or adversarial.''
Soon after her surgery, Colleen had begun to feel better, but her fatigue, migraines, and joint pain persisted--in her doctors' view, because explantation cannot always rid the system of silicone. In May, 1993, she settled her lawsuit for an undisclosed sum.
Three months later, Swanson left Dow Corning for the last time, exiting through an underground tunnel into the summer sun. At 7 the next morning, a moving truck pulled into the Swansons' driveway. The couple was headed to Bloomington, Ind., where he hoped to establish himself as an ethics consultant. The Swansons left early the next day--skipping breakfast rather than delaying their departure. ``It was a pretty day,'' recalls Colleen. ``The sun was shining. I was a little numb because I was still quite ill. But I can't say I felt sad.''

ON MAY 15, 1995, AFTER A U.S. DISTRICT COURT judge declared that a $4.23 billion global settlement between implant makers and women seeking damages was inadequately funded, Dow Corning sought federal bankruptcy protection. The parent companies then wrote off their combined $739.5 million investment in the company. Dow Corning is now battling even its own insurers, who have charged the company with fraud and negligence.
Yet momentum is swinging the company's way. Recent studies from Harvard Medical School and the Mayo Clinic, among others, have cast doubt on the link between implants and disease. But critics have attacked these studies on numerous grounds--among them, that they look only for recognized diseases, such as lupus, rather than the complex of ailments many recipients complain of. The Mayo clinic researchers themselves cautioned that ``our results...cannot be considered proof of the absence of an association between breast implants and connective-tissue disease.'' Ethically, in Swanson's view, the new findings are beside the point. The real issue is the company's failure to acknowledge and promptly investigate signs of trouble.
The ethical dimensions of the crisis, and Swanson's role in it, are already fodder for MBA classes in business ethics. Kenneth Goodpaster, who teaches such a course at the University of St. Thomas in Minneapolis, knows the story well. It was he who interviewed Swanson for Harvard's flattering studies of the company's ethics program.
His students discuss the program's failure to bring problems with implants to light. They debate the merits of a legal system that lets vital information be kept from the public by a court seal. And they talk about John Swanson. Many question his staying at the company until he could retire.
``They see him making the right decision to leave,'' says Goodpaster, ``but they think it took him a long time to do so. You might say that it takes some of the heroism out of it, but it also puts some of the humanity into it....Dow Corning was John Swanson's whole life in a lot of ways. Some people could read this case and say, `Hey, wake up, guy!' But he never claimed to be a hero. It's a story about a real human being who made an excruciatingly difficult decision. It's a personal tragedy for him and others, and it's a corporate tragedy, too.''

EDITOR'S NOTE: Informed Consent is based on an exhaustive review of court records and documents filed with government agencies and more than 100 interviews, some with former Dow Corning Co. employees. Throughout John Byrne's research, the company repeatedly declined to let its executives be interviewed. It alleges that John Swanson once sought payment not to write a book--a charge Swanson vehemently denies. The company also asserts that John Swanson's involvement in Byrne's book ``precludes the possibility of a fair, accurate, and objective evaluation of the controversy.'' John Swanson will receive half of any royalties. He exercised no editorial control.

From Informed Consent: A Story of Personal Tragedy and Corporate Betrayal...Inside the Silicone Breast Implant Crisis by John A. Byrne. Copyright Copyright 1996 By John A. Byrne. Reprinted by permission of The McGraw-Hill Companies
BY JOHN A. BYRNE