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Update On Breast Implants:
The New Evidence Against DOW Chemical
By Richard Alexander
Background
Under the proposed $4.25 billion settlement of the national class action brought by recipients of silicone gel breast implants that is presently pending before U.S. District Court Judge Sam Pointer in Birmingham, Alabama [Silicone Gel Breast Implant Multi-District Litigation Action No. 926], the Claims Administrator has begun the task of compiling an initial report on the number of persons who have submitted documented applications to the Current Disease Settlement Fund prior to the September 16, 1994 deadline and the severity of the reported injuries.
This critical stage in the case will test the accuracy of previous estimates of the number of claimants and the distribution of claims across the range of disease categories, known as "the grid." The grid, a matrix of compensation categories, sets forth a hierarchy of diagnoses and severity of injury by diagnosis on the vertical axis and the age of onset of symptoms on the horizontal axis. The resulting categories of proposed compensation on the grid range from $1.4 million [most severe injury and the youngest age of onset of symptoms] to $105,000 [lowest level of injury and oldest age of onset].
The Plaintiffs' Task
The task now facing class action counsel is to make the adjustments that will be necessary between several proposed settlement fund categories [ongoing disease, explanation, implant recipient, diagnosis/evaluation, rupture, and attorneys' fees] and the grid categories and to determine whether the proposed settlement fund is sufficient. Once this analysis is concluded, if funding is insufficient to provide class members with acceptable individual recoveries, members will be afforded a second opportunity to opt-out of the settlement, unless additional funds are made available. There is broad agreement that additional contributions will be necessary if a nationwide settlement is to become a reality.
Our firm's experience illustrates the current dilemma. Of 238 breast implant recipients represented by Alexander Hawes, LLP, following a detailed analysis of individual medical records, laboratory tests and extended physical examinations, three independent rheumatologists evaluating this randomly selected group of women have documented that 119 have histories and symptoms that qualify as grid beneficiaries. According to the current grid, compensation for these class members alone totals nearly $36,000,000. If this experience is indicative of the total population of qualified class members and their expectations, additional contributions to the settlement fund will be necessary or the number of opt-outs will generate an avalanche of individual actions unprecedented in the history of the United States.
Clearly the most financially responsible potential contributors to the settlement fund are Dow Chemical Company of Midland, Michigan, an industrial colossus, and Corning Corporation. Neither is a contributor to the settlement fund because they are no longer parties to the litigation. Judge Pointer dismissed alter ego claims against Dow Chemical and Corning Corporation, the parents of Dow Corning Corporation, and temporarily saved them from exposure to general liability and punitive damages, leaving the lesser funded subsidiary solely liable for Dow Corning breast implants and generating rumors that it would be forced to seek bankruptcy protection. The decision initially was viewed as a setback for plaintiffs, but it was made without prejudice to bringing Dow Chemical and Corning Corporation back into the case if facts so warranted.
Obviously the prospect of successfully completing the proposed settlement is enhanced with Dow Chemical and Corning Corporation contributing to the settlement fund. As a result, since March, 1994 intensive discovery has focused on Dow Chemical's and Corning's relationship to Dow Corning. That effort has resulted in the identification of new documents, previously unknown to the plaintiffs, which will be the basis of a motion to reinstate these parties as defendants to be heard possibly in January, 1995. Should the Court find there are triable claims against Dow Chemical and Corning Corporation both will be brought to the bargaining table.
The Case Against Dow Chemical
Newly discovered evidence, detailed in a masterful motion to rejoin Dow Chemical and Corning Corporation as defendants in Michiganþs Wayne County Circuit Court by colleagues David Black and Douglas Peters, reveals previously unknown agreements between Dow Chemical and Dow Corning uncovered by MDL leaders Rick Ellis, Doug Peters and Ernie Hornsby which show that Dow Chemical had responsibility for researching the bioreactivity of silica and silicone compounds used in Dow Corning breast implants from 1943 until 1992 and for controlling the quality of the products manufactured, distributed and sold by Dow Corning, including silicone breast implants. As a result of both independent and joint research projects with Dow Corning, Dow Chemical knew as early as the 1950's that the silicone and silica in Dow Corning's breast implants were bioreactive, immunogenic, toxic and inflammatory in the human body.
Based on this evidence, plaintiffs claim Dow Chemical is liable on the theories of direct products liability, negligent performance of an undertaking, negligent misrepresentation and joint venture liability. Here in summary form is the substance of the motion by Brothers Peters and Black and the stunning violation of the public trust that has been uncovered by the plaintiffs' team.
The New Evidence
Dow Chemical's direct involvement with Dow Corning's products began in 1943, the year of Dow Corning's incorporation, when Dow Chemical agreed to provide Dow Corning with its technical expertise [including all plans, specifications, formulas, data, and information] and royalty free licenses under all patents in the field of organo-silicon products. Dow Chemical also agreed to supply Dow Corning with all newly discovered technical information until 1958. Dow Chemical also undertook responsibility for researching the bioreactivity of silicone compounds on behalf of Dow Corning and continued to do so until as late as 1992. Dow Corning relied on Dow Chemical's expertise in the silicone field to such an extent that Dow Corning did not perform a single study on a breast implant before an implant was inserted into a womanþs body.
On another silicone track, Dow Chemical entered into a secret agreement in the 1960's to develop a product line of pesticides and insecticides from components of the silicone gel used in Dow Corning's breast implants.
In 1966 and 1967, Dow Chemical and Dow Corning entered into a series of express joint agreements for the purpose of research, development, evaluation and commercialization of biologically active silicone compounds. The first such agreement was on July 13, 1966, when Dow Chemical entered into a "secrecy agreement...with Dow Corning Corporation on biological properties of silicones." On October 1, 1966, Dow Chemical entered into a second "agreement... covering research and development in the field of physiological effects of certain organosilicon compounds." On February 1, 1967, Dow Corning entered into yet another "joint research agreement with the Dow Chemical Company pertaining to certain silicone products designated as DC-555, DC-555A, and compounds derived from and related thereto..." The two corporations also reached
- (a) joint development agreement relating to the physiological effects resulting from ingestion or injection into the systems of animals or men of particular physiologically active silicones, wherein in principle, the parties shall jointly share the costs and shall share the profits and losses of any commercialization.
Finally, on December 5, 1967, Dow corning entered into an agreement "with the Dow Chemical Company providing for joint research, development, evaluation and commercialization programs on the physiological effects upon the systems of animals or man of physiological active organosilicon compounds."
Pursuant to these agreements and for a period of nine years, the Dow Bioscience Research Center performed numerous experiments into the biological and pharmacological effects of silicone components of breast implants on animals and humans. Research from these joint enterprises produced results that silicones were not bio- inert. This research was never published. When the first evidence of silicone bioreactivity was discovered in the California trial of Hopkins v. Dow Corning,[1] hearings were convened by the FDA which resulted in the withdrawal of silicone gel implants from the market in 1992.
Consistent with these involvements, the scientists of Dow Chemical and Dow Corning shared a remarkable community of interest, particularly between the 1965-1975 time frame. These scientists commonly and frequently would exchange both knowledge and experience with each other. They shared laboratories and facilities to research the effects of low molecular weight organosilicon compounds, like those found in both Dow Chemicalþs DC-555 fluid and Dow Corningþs silicone get breast implants. Dow Corning modeled its toxicology department after Dow Chemicalþs laboratory pursuant to a letter by Dr. Groggin. In 1975, Dr. Robert Lake, a Dow Corning scientist, presented research showing that silicone was not bio-inert at a joint conference between Dow Corning and Dow Chemicalþs scientists. In fact, the need and common interest of both corporations to study the bioreactivity of organosilicon compounds was so great that the exchange of scientists from one corporation to the other occurred through the entire time Dow Corning was in existence.
The relationship between Dow Corning and Dow Chemical was further solidified in 1975 when the two corporations entered into a Trademark Agreement. Pursuant to that agreement, Dow Chemical admitted that it has "controlled...the quality of its [Dow Corningþs] goods" since 1943. More specifically, the agreement provided:
- The products manufactured, distributed and sold -- shall be of a nature and quality that is acceptable to Dow Company...When requested, associate companies shall... submit specimens of its products to Dow Company and shall permit inspection of associate companiesþ premises. . . to examine the quality of such products.
In 1989, Dow Chemical agreed to perform a "Good Laboratory Practices" audit on Dow Corning. Finally, in 1990, Dow Corning reached an agreement with Dow Chemical to advise and consult them in toxicology laboratory practices and protocols.
In 1948, a seminal Dow Chemical research report was published by two Dow Chemical employees, Dr. Rowe and Dr. Spencer, in combination with a Dow Corning employee, Dr. Bass, which declared silicone to be "biologically inert." This placed Dow Chemical in an authoritative position as the leader in silicone research.[2]
The importance of bio-inertness is well explained in the August, 1994 supplement to Seminars in Arthritis and Rheumatism:
- Ideal biocompatible materials are devoid of immunological, inflammatory, or toxic reactions, resist deterioration of host tissues or the biomaterial, limit alteration of host proteins, and are noncarcinogenic. Silicone was promoted for clinical application because it was thought to be biologically inert. (David Borenstein, Toxicology of Silicone).
However, by the 1950's, Dow Chemical and Dow Corning had performed studies which demonstrated toxic hazards associated with Dow Corning silicone; The first known study was in September of 1954, when Dr. Spencer of Dow Chemical reported that Dow Corning silica (this silica being the beginning and end product of silicone gel) had "quite a high order of toxicity from dust inhalation."
In March of 1955, Dr. T. K. Rowe of Dow Chemical reported that Dow Corning Degussa Dust (fumed silica added to the elastomer shell to strengthen the implant) caused diffuse cellular infiltrates and fibrocystic changes in the lungs and organs of animals.
Dow Chemical learned specifically that the silicone used in breast implants was not bio-inert in 1956 when Dow Chemical studied the biological effects of Octamethylcyclotetrasiloxane (D4). D4 became the building block of the gel used in silicone breast implants from the 1960's until they were taken off the market in 1992. The 1956 study found that the compound, if administered orally or by intramuscular injection, led to traces of siloxane being found throughout the bodies of laboratory animals. The study also found the the compound caused a "slight initial weight loss and moderate liver pathology.
A similar 1956 Dow Chemical study determined that D4 had a biological effect on the eye and that contact would cause painful and transient irritation of the conjunctival membranes. In fact, there were at least nine separate Dow Chemical reports of test results on Dow Corning Silicone Fluid. All of these reports indicate some irritation to the eyes and skin. One particular report indicates the silicone fluid caused hyperemia, edema, and general skin rawness in all cases. Some of the tests reported the biological effects of Dow Corning Fluid 360, which is "chemically the same silicone formula utilized in many aspects of breast implants."
In 1956, Dow Chemical initiated a research project with University of Miami, on behalf of Dow Corning. Dow Chemical negotiated the price of the project and determined what testing would be performed. When the test results found that a Dow Corning silicone compound entitled Z-4141 caused fat or silicone deposits in the livers of laboratory rats, Dow Chemical (not Dow Corning) retested the results. The results of these retests indicated the deposits found in the rats' livers represented silicone, not fat. Although the final report published by the University of Miami referenced several employees at Dow Chemical, no mention was made of the Z- 4141 compound. .
In 1957, Dow Corning sent Dow Chemical reports that Dow Corning 200 Fluid was "absorbed through the skin by the adrenal and kidneys of a rabbit."
In 1961, Dow Chemical tested Dow corning Fluid and found a substantial difference in the fluid when it was heat treated. Specifically, the fluid caused death in all but one of the rats, apparently because of "irritation of the respiratory tract."
In 1970, Dow Chemical discovered that Dow Corning 360 Fluid caused spontaneous death in several rats, pulmonary deposition, and vacuoles [cavities] to develop in the liver, heart, kidney, spleen, pancreas, ovary, adrenal and stomach mucosa. Also in 1970, Dr. Olson, a Dow Corning scientist newly transferred from Dow Chemical, reported that "if there is any leakage of the [breast implant], by diffusion, rupture, or by any means, some frequency of allergic reactions of patients will occur. In some cases, the problems posed are likely to be serious."
In 1975, Dr. Lake's study, which showed significant silicone bioreactivity, was presented to a joint conference between Dow Corning and Dow Chemical scientists. This research was never published.
Finally, in 1976, employees from Dow Corning and Dow Chemical studied the effect of implantation on the physical properties of silicone rubber. The study found that the subcutaneous implantation [as is performed in mammary augmentation or reconstruction] changed the physical properties of medical grade silicone rubber.
Although it is clear from the above studies that Dow Chemical knew as early as the 1950's that the silicone used in breast implants was not biologically inert, neither Dow Chemical nor Dow Corning ever published the results of any of this research. In fact, Dow Chemical indicated just the opposite to the public -- that silicone was bio-inert and safe for human use. In 1954, and again in 1959, Dow Chemical promoted the suitability of silicone products for medical uses. In October of 1974, product inserts indicated that silicone breast implants were "nonreactive to body tissue." The General and Plastic Surgery Devices Panel, in a letter to the FDA which contains public information, declared that ". . . although one pathologist has been widely quoted as claiming that he has found silicone in various organs of the body, we are not aware of any other medical professional who has observed this phenomenon." Finally, in 1992, the CEO of Dow Chemical, Frank Popoff, declared that Dow Corning's breast implants were "beyond reproach."
Conclusion
Dow Chemical had responsibility for researching the bioreactivity of silica and silicone compounds used in Dow Corning breast implants. Dow Chemical knew as early as the 1950's that silicone and silica used in Dow Corning's breast implants was bioreactive, immunogenic, toxic and inflammatory when introduced into the human body. The company did nothing to advise the public of these hazards or to stop the sale, despite the fact that Dow Chemical had the right to control and in fact controlled the quality of the products manufactured and sold by Dow Corning.
Every consumer injured by a breast implant owes a well deserved "thank you" for the effort in uncovering this public fraud. Clearly Dow Chemical and Corning Corporation will argue their own analysis of this evidence. Notwithstanding what they may claim, the evidence is indeed compelling. It is difficult to escape the conclusion that this violation of public trust should not go unpunished and that Dow Chemical should be held liable for the harm it has caused and most assuredly could have prevented.
Copies of the Michigan brief which contains this factual history and the plaintiffs' legal arguments are available by calling The Alexander Hawes, LLP at 408-289-1776.
Endnotes
[1] 1974, Dow Corning Report No. 4319, W. Boley and R. Levier, "Immunological Enhancing Activities of Organosilicone Compounds and Nonfunctional Fluids".
[2] This study had been cited in over 100 medical articles by the industry and the medical community as the foundation for the inertness fiction.
Last Updated 6/14/95
© Richard Alexander, 1994-2007.
Richard Alexander is a specialist in personal injury litigation with 30 years in-depth experience. Emphasizing working relationships with clients has led to an exceptional record of success. He has served as a member of the Board of Governors of The State Bar of California, President of the Santa Clara County Bar Association and the Board of Governors of Consumer Attorneys of California. He is a founding member of the National Association of Consumer Advocates, and heads Alexander Hawes, LLP.
Alexander Hawes, LLP is a California law firm that specializes in personal injury, wrongful death, and financial losses caused by negligence, defective products, toxic chemicals, corporate misconduct or insurance fraud on behalf of consumers, small investors, injured workers and small businesses. In addition to individual cases the firm prosecutes class actions for large groups of individuals who have suffered financial loss as a result of corporate fraud, defective consumer products, and environmental pollution. The firm holds Martindale-Hubbell's highest rating and is recognized in the List of Preeminent Law Firms in the U. S.
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