If you order your custom term paper from our custom writing service you will receive a perfectly written assignment on DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS. What we need from you is to provide us with your detailed paper instructions for our experienced writers to follow all of your specific writing requirements. Specify your order details, state the exact number of pages required and our custom writing professionals will deliver the best quality DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS paper right on time.
Out staff of freelance writers includes over 120 experts proficient in DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS, therefore you can rest assured that your assignment will be handled by only top rated specialists. Order your DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS paper at affordable prices with !
On May 15, 15, after years of controversy surrounding silicone breast implants, Dow Coming Corporation (DDC)¡Xa joint venture of Dow Chemical and its parent company, Corning Incorporated¡Xfiled for Chapter 11 bankruptcy protection. Richard Hazelton, the CEO of DCC, explained the decision ¡§It became clear to Dow Corning that to continue our current course ultimately would make it impossible to either resolve this controversy responsibly or remain a healthy company. A Chapter 11 reorganization will bring closure and preserve underlying business.¡¨
BACKGROUND MARKET OPPORTUNITIES, COMPETITIVE PRESSURES, INTERNAL COMPANY QUESTIONS
Dow Corning Corporation was a start-up venture between Dow Chemical and Coming in 14. As an incubator, the goal of DCC was to create and market a new material¡Xsilicone. While the company later proved successful, with almost 10,000 employees and revenues in excess of $ billion, it did so with the support of Dow Chemical and Coming, both looking for promising profits from the new venture.
The first silicone gel implant took place in 164. Since that time, ¡§about two million women nationwide have received breast implants, most of them for cosmetic reasons.¡¨ Although the majority of these women were satisfied with the implants, ¡§a small minority of recipients in both Canada and the United States have complained that the implants have ruptured, allowing gel to leak into the breast cavity and migrate to other parts of the body. Some women maintain that implant problems cause pain in the chest arms, and back, as well as debilitating autoimmune diseases such as rheumatoid arthritis. Some also complain that scar tissue formed around the implants, causing a hardening of the breasts.¡¨
While the silicone gel breast implants were believed by scientists at DCC to have been safe for humans, internal memos suggest that competitive pressures and a lack of attention to some animal tests and personnel complaints short-circuited safety issues for business reasons. Competitors had by 175 already cut DCC's market share in this area by a third. To counter the competition, DCC wanted to rush its new product, fib-gel, to market by June 15. Projected annual sales were 50,000. An internal memo, dated January 1, 175, stated, ¡§17 weeks, 11 days, ,04 hours, 174,40 minutes.¡¨
Gel-bleed (the seepage of silicon modules through the plastic container that housed the new liquid gel) was so evident that the implants had a noticeable greasy, even oily, sensation when handled. In an internal memo dated May , 175, sales managers stated that the implants on display at a trade show ¡§were bleeding on the velvet in the showcase.¡¨ Even members of mammary task force that had been established by DCC in January 175 expressed concern over problems that gel-bleed might cause in humans.
Animal studies conducted on rabbits in February 175 showed that inflammation occurred. A test on dogs also showed that gel had leaked internally Thomas Talcott, a product engineer with the implant team, argued for more study because of his concern that a ruptured implant sac in a human could cause health risks. When his arguments were ignored, he resigned. The fib-gel went to market in the fall of 175. A disgruntled and angry sales force started fielding complaints from plastic surgeons over gel-bleed, leaking gel, and ruptured implants. An internal memo from a sales professional stated to his superior, ¡§To put a questionable lot of mammaries on the market is inexcusable. I don't know who is responsible for this decision but it has to rank right up there with the Pinto gas tank.¡¨
One of the first lawsuits filed was by a woman who ¡§claimed that a silicone breast implant manufactured by DCC caused her to contract a disabling immune-system disorder. The case, brought in 18 by Mariann Hopkins, was among the first breast-implant lawsuits. In 11, a federal jury in San Francisco had ordered Dow Corning to pay Hopkins $840,000 in compensatory damages and $6.5 million in punitive damages. The award at the time was the largest ever in a breast-implant case.¡¨ Dow Corning claimed that this award ¡§triggered the explosion of breast-implant litigation¡K. State and federal Courts have been inundated with cases . . . against all manufacturers of mammary prostheses in which plaintiffs claim whatever injury disease or illness from which they suffer is causally related to their implants.¡¨
In response to the litigation, DCC, Bristol-Myers Squibb Co., and Baxter Health Care Corp. attempted to handle the individual suits together in a class action suit. These companies agreed to pay $4.5 billion to women who contended that implants caused illness. The settlement was designed to provide women with net payments ranging from $105,000 to $1.4 million, depending on theft physical condition and age. These amounts could be reduced if an unexpected number of women registered to participate and if companies refused to pay more. Women would have an opportunity to leave the settlement if payments were reduced, although such actions could possibly have jeopardized the entire settlement idea. C ¡§The settlement contributions would be based on each manufacturer's market share, litigation exposure, and ability to defend the claims, with Dow Corning paying $ billion, Bristol-Meyers $1.5 billion, and Baxter $556 million.¡¨ The manufacturers also had the ability ¡§to drop out if a certain number of victims chose not to participate. Each manufacturer would be left to their own discretion to determine if the number of participants was significant.¡¨ The manufacturers were trying to push this class action settlement knowing that ¡§if the cases are all tried together. . . every recipient in a successful suit would probably get a small settlement, much less than the multimillion dollar awards that a handful have gotten.,¡¨
Many people feel DCC threatened bankruptcy early on to scare women into opting to join the class action suit. The various methods used by manufacturers to get women to join the suit were not completely successful, however, as ¡§more than 11,00 women rejected the $4.5 billion settlement. Those women have reserved their right to sue implant manufacturers individually.¡¨ These individual lawsuits, coupled with the difficulties DCC experienced in coming to agreement with so many other women, led to DCC's filing for Chapter 11. ¡§The bankruptcy filing signaled the breakdown in an attempt by Dow Corning and three other corporate defendants to funnel claims through a no-fault facility somewhat similar to the still-unresolved problem of asbestos cases in the 180's.¡¨
ENTER THE ATTORNEYS
As DCC and the other manufacturers learned, when a crisis arises due to product liability, it is not easily resolved. ¡§The difficulties were legion. Among the women involved, there was a wide range of consequences and varying degrees of certainty about the link between implants and subsequent medical difficulties. The intensity of the pursuit varied from lawyer to lawyer, and the willingness of parties to settle changed with time, making patterns of settlement difficult to establish.¡¨ Two Houston attorneys in particular campaigned through public ads to solicit women who had experienced problems with gel implants. These attorneys kept their clients away from the class action suit in order to have each person appear before the manufacturer, a judge, and a jury. The lawyers won $5 million in their first trial against Bristol-Myers Squibb. These attorneys at one point had over ,000 individual cases lined up for adjudication. They were obtaining settlements of $1 million per case with fees of 40 percent per settlement. It can be argued that this factor¡Xthat is, the continuing success of the attorneys at persuading juries of the fate of injured women who were not properly informed of the gel's dangers and potential risks¡Xput Dow Corning's president and executives in the position of having to declare bankruptcy.
DCC provides a compelling modern-day example of the close relationship that developed between product liability suits and Chapter 11 filings, an issue that Congress must finally address. ¡§If bankruptcy is now the ultimate limit on liability what figure short of that can Congress agree on to avoid the danger implicit in Dow Corning's case that an otherwise viable business, and the jobs that go with it, might go down the drain of tort practice.¡¨
THE FINANCIAL PICTURE
In order to fully understand the financial implications that silicone has had for DCC, it is essential to note the sales and reported earnings of DCC and its parent companies, Corning Inc. and Dow Chemical.
In 167, just after the first silicone implant surgery DCC reported sales of $10 million. By 170, sales had climbed to $140. million on earnings of $1.8 million. By 180, DCC's reported sales soared to $681.5 million, while earnings rose to $7. million. An estimated 150,000 million individuals annually sought implants for augmentation or reconstruction. In Boston, the surgical fees for an implant could run from $,000 to $5,000, according to Dr. Sharon Webb, a plastic surgeon at the Faulkner Breast Center. Anesthesia and hospitalization could add another $,000 to the tab.
The sales growth of DCC significantly enhanced its two parent companies, Corning Inc. and Dow Chemical. In 170, Corning Inc. reported sales of $5 million on earnings of $.5 million. This figure rose to $1,5.7 million in 180 on earnings of $114.7 million. A similar impact was seen on overall sales for Dow Chemical, with reported sales of $1,11 million in 170 on earnings of $10 million. These figures rose to $10,66 million in sales on earnings of $805 million in 180.
The 180s saw continued growth in the breast implant market. This growth led DCC's reported sales of $01.1 million on earnings of $5. million in 185. ¡§By the middle of the decade, surgeons were performing more than 10,000 breast implant operations every year. The average patient was a college educated woman in her early thirties, who was married and had two children.¡¨ By 10, DCC had reached sales of $1,718. million on earnings $1711 million. Corning Inc.'s sales were $,40.5 million on earnings of $ million; and Dow Chemical reported sales of $1,77 million on earnings of $178 million.
Unfortunately for DCC, as discussed earlier, the company soon found itself at the center of one of the largest product liability suits in American history. The suits caused DCC's litigation expenses to rise sharply. Reported litigation expense was $5 million in 11. This figure rose to $6 million in 1, and, by 1, DCC reported spending over $640 million in litigation. In 1, DCC reported sales of $,04.7, while actually losing $87 million dollars. DCC had 14 sales of $. billion but reported a $6.8 million loss, which it attributed to the expense of the breast implant claims.
DCC's financial outlook appeared grim. Merrill Lynch estimated that DCC would earn $8.0 per share in 15 (down from the earlier estimate of $.00 per share) and $.15 per share in 16 (down from the earlier estimate of $.50 per share). Merrill Lynch also reduced the five-year earnings per share growth rate for DCC to 0%.
A HISTORICAL PERSPECTIVE
In 176, the federal government passed an amendment to the federal Food, Drug, and Cosmetic Act which provided stricter reporting and inspection standards for all new medical devices. At this time, there were 1,700 types of devices on the market, many of them containing silicone. Through a grandfather clause, these devices were allowed to remain on the market with minimal Food and Drug Administration (FDA) review. A manufacturer simply filed a ¡§510(k)¡¨ form informing the FDA of the new product and its similarity to an existing product already on the market. In 16, the FDA acknowledged that there were 58,000 medical devices, many containing solid silicone, that entered the market through this 510(k) process.
It was almost 1 years before further government attention was given to the breast implant controversy. ¡§A Public Citizen, physician Dr Sydney Wolfe, said in a petition,' . . . an increasingly larger pool of women is being created who may in the prime of their lives, ultimately develop chronic illness, disfigurement and disability because of the implants (silicone).¡¨ Dr. Wolfe began to publicly attack manufacturers and plastic surgeons for downplaying the potential health risks. Opponents of Dr Wolfe agreed with Bruce Hansel, a biochemist and bioengineer at the Emergency Care Research Institute (ECRI), a watchdog group that had been tracking silicone-containing medical devices. Hansel stated, ¡§¡¥You can nit-pick anything to death. There will never be a perfect biomaterial,' but ¡¥I would say that silicone in my view is probably the biomaterial of the 0th century It is the best biomaterial we have going for us now.¡¨' ¡§Manufacturers continue to deny a link between such illnesses of the human immune system and breast implants, but various doctors have concluded that such causation exists.¡¨
As a result of conflicting expert medical data and opinions, the FDA once again became involved in the breast implant controversy. The agency announced, in November of 188, that although manufacturers could continue to produce breast implants, they would have to provide more detailed information on the safety concern for a 11 investigation. Unfortunately the 11 investigation proved uneventful. Although the FDA panel cited the overall lack of safety data, it did not move to ban the sale of breast implants. The panel noted testimony from cancer patients (and their psychological benefits from the implants) as an integral part of their decision.
Finally, in 1, after DCC was ordered to pay $6.5 million in punitive damages to a breast implant claimant, FDA Commissioner David Kessler announced a 45-day moratorium on the sale of silicone implants. ¡§Since April 1, the FDA has banned breast implants for cosmetic purposes and allows them only for reconstructive breast surgery as part of the controlled clinical studies.¡¨ This was the last significant act by the federal government in the breast implant controversy.
As illustrated, the swirling controversy in the DCC case can be summarized as whether or not the silicone gel breast implants cause medical disorders in women who have had implant surgery. By 11, ¡§the FDA had received ,500 reports of illnesses or injuries associated with the implants, which have been used in one million women. But the degree of risk was unclear because extensive research had not been done.¡¨ As pressures mounted regarding the product's safety, Dow adamantly ¡§denied any link between the implants and illness.¡¨ Moreover, ¡§rather than wait for results from the [FDA] research, Dow undertook to determine the safety of silicone gel implants.¡¨ The Dow study of silicone implants in March 1 ¡§reported that the silicone gel in the implants altered the immune systems of laboratory rats . . . but [rats] are more susceptible to inflammatory reactions than humans.¡¨
THE CONTROVERSY
Women who have had medical problems with their implants allege, with their doctors' support that the following medical disorders were present autoimmune disease, breast cancer, arthritis, abnormal tissue growth, scleroderma, lupus erythematosus, fatigue, and nerve damage. Still, DCC has maintained the safety of the implants, stating ¡§plaintiffs [the women] claim that whatever injury, disease or illness from which they suffer is causally related to their implants.¡¨
Numerous studies, including the Mayo Clinic Study, the University of Southern California Study, and a French International Study, reported similar results. The French Ministry said that an analysis of international research ¡§showed that the risk of contracting autoimmune diseases and cancer after the implantation of silicone breast implants was no greater than in the general public.¡¨ Scientists involved ¡§noted that no study could completely dismiss the possibility that breast implants contributed to medical disorders.¡¨ The degree of safety may never be completely known, but as of 15, ¡§about 5% of the two million American women with silicone implants have demanded compensation for side effects.¡¨
THE RIGHT TO KNOW
¡§Dow Corning has actively covered this issue up,¡¨ said Dr. Wolfe, who is director of the Public Citizen Health Research Group in Washington. ¡§They are reckless and they have a reckless attitude about women.¡¨ Wolfe continued, ¡§DCC was only thinking of themselves when they ¡¥repeatedly assured women and their doctors that the implants were safe' while keeping ¡¥guard over hundreds of internal memos that suggested that some of Dow Corning's own employees have long been dissatisfied with the scientific data on implants.'¡¨
The release of these internal memos suggests that Dow has long known of major problems with the silicone implants it has marketed since 175. The following are highlights from a sample of the memos to and from Dow scientists
Jan. 8, 175 Memo from Arthur H. Rathjen, chairman of the Dow implant task force, as Dow rushed a new implant to market ¡§A question not yet answered is whether or not there is excessive bleed [leakage] of the gel through the envelope. We must address ourselves to this question immediately. . . . The stakes are too high if a wrong decision is made. . .
Sept. 15, 18 Memo from Bill Boley ¡§Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.
April 10, 187 Memo to Rathjen and others suggesting that Dow was considering a study to review 1,50 implant recipients ¡§The cost of this data is expected to be minimal, less than $10 million.¡¨ The study never took place.
In response to these memos, Dow Corning stepped up an ad campaign that it had started in the fall of 11. In newspapers across the country, DCC urged women with questions about implants to call a company hotline. The ads said that instead of ¡§half-truths,¡¨ callers would receive information based on 0 years of valid scientific research. But when some women called, they were told that the implants were ¡§100 percent safe.¡¨ Shortly afterward, the FDA warned Dow Corning that some of the information on its hotline was ¡§false or used in a confusing or misleading context.¡¨
An ethical issue at hand, however, is not only whether the implants do or do not cause harm to patients, but also that DCC failed to inform stakeholders and clients that some of their employees felt there was reason for concern about safety. Failure to accurately and timely inform consumers of questionable product uses violated the right of these women to know. ¡§If you do not have data on the range of risks and problems, you are not free to choose, you are free to be ignorant. Informed consent requires both information and choice. Since the companies have not supplied the information, this is a dubious choice.¡¨
AFTERMATH
In June of 14, DCC began to make announcements that it may have to declare bankruptcy if too many women opted out of the $4.5 billion settlement. These comments ¡§led some financial analysts to suggest that the Chairman (Keith McKennon made the statements) was trying to ¡¥scare' women into joining the settlement, which could potentially save the company millions of dollars in litigation fees.¡¨ DCC and the other manufacturers involved in the case have attempted to make the settlement appear generous on their part, but ¡§it is hardly the simple and generous solution described. In reality, the payout to each woman would depend on the total number of claims filed and could decrease dramatically as the number of plaintiffs climbs. And the rights of women to drop out of the plan and seek their own settlements would actually be sharply curtailed. Thousands of sick women could lose their legal access to any compensation altogether. ¡¥This is not insurance,' Norman D. Anderson, a Johns Hopkins University professor stated, who has treated hundreds of patients with problems related to silicone implants, ¡¥This is pennies-on-the-dollar reimbursement.'¡¨
When DCC felt it had become financially overburdened with the trials, it followed through on the threat and filed Chapter 11. This was ¡§a move that threaten[ed] to unravel a $4.5 billion breast implant settlement and has frozen thousands of individual lawsuits. The company's Chapter 11 filing was akin to protective bankruptcy-filing steps taken by big companies in other important product liability cases, which delayed payments to recipients for years. Under Chapter 11, a company gets a reprieve from bills while it works out a way to pay creditors and survive as a healthy business.¡¨
DCC may have modeled its behavior after its parent company, Dow Chemical Corporation. In an attempt to avoid litigation, Dow Chemical Corporation has maintained that it was not aware of DCC's research activities in silicone. Dow Chemical Corporation was initially dismissed from the case until ¡§a federal judge reinstated Dow Chemical as a defendant in thousands of breast implant lawsuits, raising the possibility of new negotiations in a landmark product liability settlement. . . . The ruling ¡¥means Dow Chemical can no longer sit on the sidelines and pretend it is not a player in this litigation.¡¨'
Judge Arthur Spectors approved in December 1 ¡§Dow Corning's $4.5-billion reorganization plan, including $. billion to settle claims brought by silicone gel breast implant recipients. The remaining $1. billion will be paid to commercial creditors, in part through a $00 million¡X$1 billion bond issue.¡¨ Spectors's ruling enabled Dow Corning to emerge from bankruptcy, even though appeals were expected. The company still had to resolve 170,000 implant recipients' product liability claims. ¡§The proposed settlement plan, which represents an agreement between 4% of the plaintiffs and the company, would protect Dow Corning and third parties such as Dow Chemical from future lawsuits. . . . It would also pay $,000¡X$00,000 to plaintiffs, depending on their medical condition.¡¨
Plaintiffs agreed in the settlement to waive punitive damages. Dow Corning established a cap of $400 million to settle claims by plaintiffs ¡§who choose the plan's litigation provision[,] . .. an option for women who do not agree with the settlement offer. The only appeals that could prevent the plan from going forward are challenges to the settlement amount or to the third-party release provision, says Barbara Houser, Dow Corning's lead bankruptcy attorney.¡¨
FINAL THOUGHTS
DCC's silicone breast implant troubles occurred in a free-market, capitalist society. A free market encourages innovation, but it can also lead to corporate manipulation and to the introduction of dangerous products into the market. Marcia Angell, a physician and executive editor of The New England Journal of Medicine, concluded in her book Science on Trial The Clash of Medical Evidence and the Law in the Breast Implant Case that ¡§[o]nly by relying on scientific evidence can we hope to curb the greed, fear and self-indulgence that too often govern such disputes. This is the lesson of the breast implant story.¡¨ Charles Rosenberg, professor of history and sociology of science at the University of Pennsylvania, argued in a New York Times review of Dr. Angell's book that ¡§it is difficult to share her hope that scientific evidence can or will translate easily or naturally into social policy. She is dismayed, for example, that regulations ¡¥should be influenced by political and social considerations.' Yet this is the way our system works. In most policy matters, scientific evidence is only one among a complex assortment of factors that interact to produce particular decisions.¡¨ A careful reading of the events, stake-holders, and outcomes in the silicone breast implant controversy reveals the social, economic, legal, and political¡Xas well as scientific¡Xfactors involved ¡§the practice of Federal regulation, the relationship between science and courts, the lack of consistently enforced professional standards in law, medicine and journalism.¡¨ A major lesson from this case also involves the role of the plaintiffs. The Houston lawyers' relentless pressure with inconclusive medical facts on Dow Corning, along with their courtroom successes, demonstrates that ¡§facts¡¨ alone are insufficient factors in determining truth. Associated Press. (April 1, 14). 5 firms join implant settlement. Boston Globe, 44.
Associated Press. (July 1, 14). Firms may face thousands of suits. Boston Globe, 1.
Associated Press. (Aug. 5, 14). FDA is petitioned to outlaw saline-filled implants. Boston Globe, 17.
Associated Press. (Sept. , 14). Judge finalizes $4.5B settlement from breast implant maker. Boston Globe, .
Associated Press. (Sept. 16, 14). Women rejecting implant award. Boston Globe, 7.
Associated Press. (Feb. 15, 15). Couple wins $5.M in breast implant case Dow Chemical faulted. Boston Globe, 88.
Associated Press. (March 1, 15). France readmits breast implants. Boston Globe, 4.
Associated Press. (March , 15). Dow freed from suit. Boston Globe, 14.
Associated Press. (April 6, 15). Company reinstated in implant lawsuit. Boston Globe, 7.
Associated Press. (May 11, 15). Jury selection is halted over an implant and Dow Corning denies trying to influence liability. Boston Globe, 14.
The best-laid ethics programs. (March , 1). Business Week, 67-6.
Breast implant makers prepare $4B settlement. (March 7, 14). National Underwriter, 6.
Burton, T. (July 14). Adding insult to injury. Progress ive, 8-0.
Carelli, R. (Jan. 10, 15). Justices uphold breast implant award. Boston Globe, 10.
Chisholin, P. (March , 1). Anatomy of a nightmare Dow Coming fights a public outcry. Maclean's, 4¡X4.
Dow Chemical not liable in implant case. (March 0, 15). Facts on File, Medicine and Health, .
Dow Corning announces medical silicone resins. (May 0, 14). Chemical & Engineering News, .
Dow Corning down for the count A new high flier for Boeing. (May 1, 15). Boston Globe, 48.
Dow Corning mulls over filing for bankruptcy. (June 0, 14). Chemical & Engineering News, 8.
Facts on File. (Dec. 1, 14). .
Facts on File. (Feb. , 15). 88.
Facts on File. (March , 15). 154.
Foreman, J. (Jan. 1, 1). hnplants Is uninformed consent a woman's right? Boston Globe, 1.
Foreman, J. (Jan. 1, 1). Women and silicone A history of risk. Boston Globe, 1.
Foreman, J. (Jan. 5, 1). Safety of solid silicone at issue. Boston Globe, 1.
Foreman, J. (May 15, 1). Lawyers fight over limits of implant trials. Boston Globe, 5.
Foreman, J. (June 17, 14). Breast implant study criticized timing, funding of report at issue. Boston Globe, 4.
Foreman, J. (Nov. 0, 14). Dec. 1 deadline to join implant lawsuit. Boston Globe, 6.
Grimmer, L. (Nov. , 1). Silicone-gel implant records altered, company admits. Boston Globe, .
Haney, D. Q. (Dec. 1, 14). Harvard doctors quit implant study, citing conflict. Boston Globe, 5.
Implant makers near a deal. (Feb. 1, 14). Business Insurance, 1, 51.
Lehr, D. (Sept. 10, 1). 4.75B accord eyed on breast implant plaintiffs, manufacturers agree on compensation fund. Boston Globe, 1.
McCarthy, M. (April , 14). U.S. breast implant agreement. Lancet, 7.
Neuffer, F. (March 0. 1). Maker quits implant market Dow Corning cites drop in sales, sets up fund. Boston Globe, 1.
Please note that this sample paper on DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS is for your review only. In order to eliminate any of the plagiarism issues, it is highly recommended that you do not use it for you own writing purposes. In case you experience difficulties with writing a well structured and accurately composed paper on DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS, we are here to assist you. Your cheap custom college paper on DOW CORNING CORPORATION AND SILICONE BREAST IMPLANTS will be written from scratch, so you do not have to worry about its originality.
Order your authentic assignment from and you will be amazed at how easy it is to complete a quality custom paper within the shortest time possible!
