10/02/95 Informed Consent

Informed Consent

The controversy surrounding silicone breast implants has plunged Dow Corning Corp. into bankruptcy. More than 8,000 women still have lawsuits pending against the company, which has spent $1 billion defending itself. On Sept. 13, a federal judge ruled that suits against parent companies Dow Chemical Co. and Corning Inc. could proceed despite the bankruptcy filing. All this because of a product that produced less than 1% of Dow Corning's revenues.
John E. Swanson viewed this debacle from a unique vantage. For most of 27 years at Dow Corning, he shaped its ethics program, which was acclaimed as a model for Corporate America. His wife, Colleen, had Dow Corning breast implants. After years of devastating illnesses, she became convinced that her implants were destroying her health--and that the company had failed to inform women of the risks. In time, John came to agree. He also came to believe that his company had acted unethically through much of the crisis.
The circumstances John Swanson faced were remarkable. But his experience is emblematic of the ethical conflicts any executive can face. What happens when personal values clash with corporate beliefs? What happens when a moral choice separates you from your company's official position and from your colleagues in a close-knit organization? Here, in an adaptation from a forthcoming book by Senior Writer John A. Byrne, is the harrowing tale of how one manager faced those questions.

FOUR WEEKS EARLIER, COLLEEN SWANSON HAD been out cold on an operating table at Cleveland's Mount Sinai Medical Center. A surgeon had worked three hours to remove the silicone breast implants that had been in her chest for 17 years--and that Colleen was sure were the cause of health problems that had for years eroded her life.
Since the grueling operation, she had been bandaged from collarbone to waist. Now, on a bright and beautiful morning in July of 1991, she would get the first glimpse of how she looked. Her husband, John, had already left for his job at Dow Corning--the maker of the implants.
Once, John had loved his job and his life in little Midland, Mich. But for years, he had shared Colleen's anguish, comforting her through ailments including severe migraines, debilitating joint pain, and extreme fatigue. And when he, like Colleen, concluded that her implants were the cause, he supported her decision to have them removed. Still, Colleen had purposely failed to remind him that today was the day to take off the bandages. ``I really felt I wanted to deal with it myself,'' she recalls.
Ever since her surgery, she had tried to imagine how she would look. A petite woman of 55, Colleen was always impeccably turned out, her quietly tasteful clothes reflecting her conservative Midwestern background. She had sought the implants only to bring her small, uneven breasts closer to average. Now she wondered: Would she despise her appearance? Would John? ``I knew it was going to be bad,'' she says, ``because my surgeon had told me that most of my breast tissue had been destroyed.''
She spent hours that morning summoning her courage. At last, she eased herself into a warm bath and gently splashed water over the bandages in hopes the water would penetrate the plastic tape and lessen the pain of its removal. But the bath failed to loosen the dressing, and for a time she gave up.
That afternoon, she tried again. Alone in her bedroom, she lowered the shades and lay on the bed. She began to pull at the tape, gritting her teeth against the pain. Only when the bandages were tossed aside did she glance down. What she saw made her cry out, then shut her eyes, not wanting to see any more.
She climbed out of bed and walked to the bathroom, consciously avoiding the full-length mirror on the bedroom wall, and went to the smaller mirror over the sink. Before flicking on the light, she closed her eyes once more and tensed. Finally, she stared at her reflection.
Thick, red, six-inch scars curved across each side of her chest where the creases beneath her breasts had been. Instead of breasts, there were just ridges of folded, discolored skin--like deflated balloons that had held air a long time. The left side of her chest, where more silicone had apparently leaked into her body, was nearly concave.
Colleen stared at herself for four or five minutes. She didn't recognize the frightened and pitiful woman whose trembling body was forever disfigured. Finally, she stepped into the shower and let the water wash the dried blood from the wounds. She tried to calm herself and relax, but she couldn't hold back the sobbing. ``I cried and cried and cried,'' she recalls. ``I cried for a long time.''

SEVEN MONTHS EARLIER--IN LATE DECEMBER, 1990--John Swanson had opened an interoffice envelope marked ``For Addressee Only'' to find a shocking memo. Two company officials, it alleged, were trying to destroy internal reports that showed far higher complication rates for silicone breast implants than Dow Corning had ever acknowledged. These were serious allegations under any circumstances, but for Swanson, they had great personal significance. The memo came from the company's medical director, Dr. Charles F. Dillon, who was asking the Business Conduct Committee on which Swanson served to investigate ``a violation of corporate, professional, and commonly accepted business ethics.''
Dillon's account said that Greg Thiess, a senior litigation attorney, had approached Mary Ann Woodbury, a research scientist, and asked her to destroy all copies of a memo in which she had analyzed implant complication rates. Disturbed, Woodbury had asked Dillon to join her and Thiess, and the attorney had repeated his request. ``Greg stated to us that he was acting at the specific request of Robert Rylee II, vice-president and general manager of the health-care business,'' Dillon wrote, adding: ``He also stated that the information contained in the memos would compromise projects that he was then working on in Dow Corning product-liability litigation and be adverse to the company if publicly revealed....''
Every night, John and Colleen had been debating whether she should have her implants removed. Both had begun to wonder if Dow Corning had failed to inform patients of known risks. Dillon's memo was a part of the puzzle--but it didn't reveal the complication rates Woodbury was reporting.
The Business Conduct Committee scheduled a Jan. 3 meeting to air the incident. Eager to learn more, Swanson phoned Woodbury that morning. ``Can you give me just a brushstroke idea of what it is we're talking about that Bob Rylee is so concerned about?'' he asked.
Woodbury said she had studied complaint data from company files and other sources, including the government. She concluded that complaints received by the company were probably but a portion of the actual number because ``it's only those that get back to us through a doctor's office.'' Many probably went unreported. Woodbury also believed the company overestimated the number of implant recipients, which would lower the complication rate. In the sample she studied, Woodbury had found, 30.3% of women with implants experienced problems, and 13% had the implants replaced within five years.
As it turned out, the Business Conduct Committee meeting was postponed several days. Swanson prepared the agenda, but Richard A. Hazleton, then general manager of the industrial products group, asked him not to attend. Swanson suspected it was because he seemed sympathetic to Dillon. Though taken aback, he didn't argue--perhaps because he knew he was beginning to be conflicted about implants.
So his knowledge of the session came from a summary prepared by other members of the conduct committee. The document confirmed that Thiess had been following Rylee's orders. It said: ``Bob Rylee indicated that when he received the information...,he was very concerned that the way it was stated was prejudicial to Dow Corning's interests and could have adverse impact in future litigation situations. He stated he did not intend in this case, nor does he advocate in general, suppressing either factual information or professional conclusions or opinions.'' But Rylee wanted documentation that made clear ``the distinctions between facts, conclusions, or opinions of people inside and outside Dow Corning with which Dow Corning agrees, and conclusions or opinions with which Dow Corning does not agree.''
The incident, the memo added, would serve as a springboard to develop guidelines for resolving future conflicts. Swanson was bitterly disappointed that his colleagues had skirted the larger issue: Was the company deliberately underestimating complication rates?
Dillon was also unhappy. He had been urging Rylee to fund studies of basic cancer and mortality issues, complication rates, and whether silicone could cause immune diseases. Now he doubted that would ever happen.
Four months later, the doctor quit. Before he left, Swanson questioned him about implants. Dillon couldn't say for sure if silicone posed a risk, he told Swanson; the research wasn't complete. But he surmised that some women probably couldn't tolerate silicone--and there was no screen to identify them.
``Good luck,'' Dillon said. ``Dow Corning is going to need a person like you.'' Swanson supposed it was a compliment. But he wondered just what he could do.

IF DOW CORNING WAS AWASH IN LEGAL PARANOIA, it was small wonder. Since 1963, when it introduced breast implants, there had been mounting complaints that the devices ruptured far more frequently than expected, that even intact implants leaked silicone, and that silicone caused myriad illnesses. In 1984, Dow Corning had lost its first major implant lawsuit; the jury, persuaded that the company had concealed problems, had found it guilty of fraud.
In 1989, after someone leaked an internal study showing ``an increased incidence of fibrosarcomas at the implant site,'' Washington-based Public Citizen's Health Research Group had sued the Food & Drug Administration to release the results of all safety studies on silicone gel that Dow Corning had given it. In response, shortly before Dillon sent his memo, a U.S. district court judge had ordered the FDA to release the results of two decades' worth of company studies. Moreover, the judge had chastised Dow Corning for invoking secrecy orders it had won in earlier court battles to prevent him from hearing expert testimony on the studies.
The press had begun reporting that silicone leaking from implants might cause auto-immune-system diseases such as lupus and rheumatoid arthritis. And Congress was about to hold hearings on implant safety.

OVER THE COURSE OF HIS DOW CORNING CAREER, John Swanson had become, in a sense, the conscience of the corporation.
A lean, fair man who looks as though he were made to sit behind a desk in a prudent Brooks Brothers suit, Swanson joined the company in 1966, at 30, as advertising supervisor and soon became manager of industrial marketing. His break came when a speech he wrote impressed William C. Goggin, then chairman and CEO. Goggin began to have Swanson write his speeches and to seek Swanson's advice on issues such as launching a campaign to end the confusion between Dow Corning and its parents, Dow Chemical and Corning.
After Goggin retired in 1975, his successor, Jack S. Ludington, also came to rely on Swanson. Dow Corning was now deriving 45% of its nearly $300 million in revenues overseas, and one issue that concerned Ludington was whether the company adhered to the same values in far-flung outposts as in Midland.
Public confidence in U.S. corporations had been hurt by revelations of companies bribing foreign officials and making illegal political contributions. Dow Corning hadn't been involved, but it had a growing business in developing countries where kickbacks and bribes were common. In 1976, Ludington asked Swanson and three other managers to form a Business Conduct Committee to draft guidelines for ethical conduct, develop a process for monitoring business practices, and recommend ways to correct questionable activities.
Few would consider corporate ethics riveting, and in 1976, Swanson was not among them. He considered himself more pragmatic than idealistic. He had never embraced religion. But he prided himself on his integrity, a value he felt he shared with his father, a conservative Republican who owned a grocery store in Minneapolis.
As Swanson began traveling to discuss ethics with often skeptical colleagues, he became intrigued by his task. Could a corporation reconcile the conflict between the quest for profit and socially responsible behavior? His assignment became a challenge: How do you convert ethics from simple pieties to part of the ethos of a global organization?
Swanson led the development of a code of ethics entitled A Matter of Integrity. The code detailed the responsibilities of the corporation and its employees and outlined proper relations with customers and suppliers. In bold type, the introduction asserted: ``We will act with the idea that everything we do will eventually see the light of day.''
But what distinguished the ethics program was its active and visible Business Conduct Committee, of which Swanson was the sole permanent member. The committee, staffed by top executives in rotating assignments, conducted face-to-face meetings with executives around the world that explored such sensitive topics as pricing and kickbacks. The sessions helped make ethics central to Dow Corning's culture.
What Swanson had seen as an assignment to dish out management's flavor-of-the-month became a long-term commitment. He now viewed the program as noble and informed, and with Ludington's support, he emerged as its leading proponent.
In 1984, researchers from Harvard business school undertook what became a series of laudatory studies of the program, and Swanson became a nationally recognized expert on business ethics. ``John Swanson was much more genuine than most corporate ethics officers,'' says Laura Nash of Boston University's Institute for the Study of Economic Culture. ``John had a comprehensive view that this was about a way of thinking.'' By 1990, Swanson, now senior consultant for communications and business conduct, was devoting nearly half his time to ethics--updating the code, making presentations to employees, and organizing and writing conduct reviews. All along, he strove to build a moral consensus that could guide employees to do the right thing.

JOHN AND COLLEEN MET IN MID-1973, THREE years after the end of his first marriage. Colleen, 34, feisty and vivacious, was also divorced and, like John, she had two children. Within four months, the couple wed.
At about the same time, a Dow Corning chemist, Silas A. Braley, moved into John's department. For years, Braley had helped doctors develop medical applications for silicone. Now, he was to tour the country, armed with a case full of artificial joints, ears, chins, and breast implants, promoting the use of silicone body parts. Swanson had known Dow Corning made breast implants, but working with Braley made him far more aware of this small, curious part of the business.
A month or so after the Swansons married, they accompanied Braley and his wife to Detroit, where Braley was to do a radio show. During the drive, there was plenty of conversation about breast implants. Colleen asked many questions. For every one, she says, Braley had a reassuring answer. He told Colleen that if she wanted implants, he could arrange for a surgeon who was among the best at the procedure to do the operation. Subsequently, she read a Dow Corning brochure that reassured women, among other things, that implants could be expected to ``last for a natural lifetime.''
Says Colleen: ``I had been advised by the one person who represented the best state-of-the-art knowledge of medical uses of silicone in the world. He knew the most competent plastic surgeons for this procedure in the U.S. Dow Corning had originated the silicone implants and was a highly reputable organization....[B]ased on Si's reputation and Dow Corning's, I felt very confident that silicone implants were safe.''
So, in March, 1974, the Swansons packed Colleen's Chevrolet Impala convertible and headed for Florida. In the trunk were suitcases full of summer clothes for John, Colleen, and her two kids. Another suitcase held a box containing a pair of vacuum-sealed, sterile silicone breast implants. They were to be given to Dr. James L. Baker Jr., the surgeon chosen by Braley, to replace the pair he would stitch into Colleen. The family would go to Disney World. Along the way, Colleen would visit Dr. Baker, who had agreed to operate for $100 if the Swansons brought the replacement implants. Most surgeons were charging between $1,000 and $3,000.
The day before the surgery, the Swansons visited Dr. Baker. He took Colleen's medical history, outlined the procedure, and examined her breasts for tumors or cysts. She then signed a form confirming she had been informed of potential difficulties. The operation had been done for several years, it said, but ``the end results are not and cannot be determined for a number of years to come.'' It also said that ``in a small percentage of cases,'' implants might not be tolerated and would have to be removed. But Baker assured her of the operation's high success rate, Colleen says, and she experienced no doubts. Colleen had surgery the next morning. Four days later, she had a final checkup. ``Patient has had beautiful results,'' Baker noted. The family headed home.
The Swansons were still newlyweds and very much in love. Many nights, they shared candlelit dinners by the fireplace. Each weekend, they'd drive to a new Michigan locale, where Swanson would golf with colleagues while Colleen and the other wives shopped, until they all met in the evening for dinner.
Then, soon after her surgery, Colleen began suffering dreadful migraines. A brain scan revealed no cause, and the pain would vanish for days, but it always returned. Her doctor began injecting painkillers, and an oxygen tank was placed by her bed because anxiety would cause her to hyperventilate.
Beginning two years later, she was beset by one ailment after another. She developed lower back pain so severe she had to quit her job as a dental assistant. Then came numbness in her arms and hands. Periodically, rashes would render her chest as red and shiny as a severe sunburn. She also developed adhesive capsulitis, which caused pain and stiffness in her left shoulder.
Colleen consulted numerous specialists and underwent countless tests, but no one could explain what was wrong. And still her ailments multiplied. She became so fatigued she would go to bed right after dinner. Then, her breasts became rock hard, and she felt a constant burning in her chest. In time, pain began to sear through her left arm and down into her ring and index fingers. Then it enveloped her hips and neck. At one point, her weight, normally 105 pounds, fell to 89. The perky and attractive woman John had married seemed to be dying. (continued in next file)
BY JOHN A. BYRNE