Fw: Informed Consent ... Business Week Article ~ 1995

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Subject: Informed Consent ... Business Week Article ~ 1995

> http://www.businessweek.com/1995/40/b34441.htm

> >

> 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.

>

> 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, came to agree. He also came to

> believe that his company had acted unethically through much of the crisis.

>

> The circumstances 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 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, , had already

> left for his job at Dow Corning--the maker of the implants.

>

> Once, 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 ?

> ``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-- 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. 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 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 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, 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 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, 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 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 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. `` Swanson was much

> more genuine than most corporate ethics officers,'' says Nash of

> Boston University's Institute for the Study of Economic Culture. ``

> 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

> , she had two children. Within four months, the couple wed.

>

> At about the same time, a Dow Corning chemist, Silas A. Braley, moved into

> '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....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 , 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. 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

> had married seemed to be dying. (continued in next file)

>

> BY JOHN A. BYRNE

>

>

>

>

>

>

> Updated June 13, 1997 by bwwebmaster

> Copyright 1995, by The McGraw-Hill Companies Inc. All rights reserved.

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