Melinda Barrow 3

Since the explant, Plaintiff has been to many doctors in her quest to improve her health. [FN56] Her husband described her improvement as a slow and gradual process, stating that since the end of 1995, she has continued to be thin, but not deathly so. Plaintiff continues to get mouth sores, rashes on and numbness in her breasts, broken blood vessels and bruises in her hands, itchy rashes, blotches and coldness in her legs and ankles, and urinary tract and ear infections; and she also suffers from fatigue, headaches, and constipation. [FN57] She still suffers pain in her back and in the muscles behind where the implants had been located. However, these problems do not occur as frequently since the explant was performed. Plaintiff continues to suffer from very sharp pains in her breasts, and her breasts are permanently scarred from the explant. [FN58]

FN56. For instance, Plaintiff has seen Dr. Ira Klein and Dr. Andrew D. Campbell in Houston, Texas; Dr. David Lebioda, Dr. Frank Vasey, Dr. Laurie Barclay and Dr. Patrick Brady in Tampa, Florida; Dr. Bower (rheumatologist) in New Jersey; and Dr. Lyle Wadsworth (internal medicine) and Dr. John Gaffney (chiropractor) in Deland, Florida. She has also seen Dr. Sandra Houston, Dr. Tomas Bocanegra, Dr. Udita Jahagirdar, Dr. H.G. Robinson, Dr. White, and Dr. Jamie D. Carrizosa.

FN57. Dr. Campbell confirmed these symptoms, stating that when he saw Plaintiff in September of 1997, she complained of being very tired, having poor energy, mucous in her throat, yellow stools, sinus problems and headaches, poor appetite, earaches, tender breasts, lesions on her legs, inflammation of her hair follicles, and of being prone to infections. She was pale and thin in appearance and had livedo reticularis or lacy, motley coloration of the skin, indicating a problem with the blood vessels and circulation, and a tendency to bruise and bleed easily. Dr. Campbell noted rashes on Plaintiff's legs, face, breasts, and abdomen. He felt the cause of these problems was the effect of silicone on her immune system which, due to silicone stimulation, prevented her from handling body processes as a normal, healthy person would. Dr. Wadsworth also testified to the symptoms which Plaintiff reported and which he observed in his treatment of her since August 5, 1991. Dr. Kotzin stated that Plaintiff did not exactly have signs of livedo reticularis, a vascular rash seen on the arms, legs, and torsos of normal people due to spasm, inflammation, or change of blood vessels, although he acknowledged that he had seen reference to this in the records of some but not all of her doctors, particularly Dr. Vasey. Dr. Kotzin noted that this can be a sign of poly-arthritis and in severe cases is present constantly instead of coming and going, as occurs in normal patients. In severe cases it can be related to the pathology of a disease until it is treated or goes into remission. It is a blotchy rash which is seen in normal individuals who do not have defined connective tissue disorder ("CTD"), and it comes and goes in persons who are pathologic. Dr. Kotzin felt that Plaintiff's livedo rash was not noted as being constant. He admitted seeing laboratory results showing elevated IGM, rheumatoid factor, and elevated immune complexes on Plaintiff. Further he opined that Plaintiff suffers from depression which can cause physical symptoms like fatigue, malaise, and myalgia. He testified that he had seen women with Plaintiff's symptoms in his practice, and a significant percentage, although not all, have depression whether they have breast implants or not. Often the depression makes the symptoms worse, but it is possible that the symptoms make the depression worse. Plaintiff's telangiectasis, or discrete dilated blood vessels, is seen in women without breast implants and without defined connective tissue disorder according to Dr. Kotzin.

FN58. Plaintiff's Exhibit 1.60(a), (b), & (c). Dr. Worthing testified that he last saw Plaintiff on December 4, 1995 and told her that he could not make the scars on her breasts look better. Deposition of Worthing at 9 & 45.

Dr. Campbell testified that while Plaintiff is not a malingerer and wants very much to get well, he did not see significant improvement in her condition between 1994 and 1997 when he treated her. In the opinion of Dr. Campbell, Plaintiff will not be able to work as she is weak and prone to chronic infections. Dr. Houston concurred.

Presently, to help alleviate her physical problems, Plaintiff and her husband endeavor to use only natural foods and products. They watch for artificial preservatives or coloring in food, avoid refined sugars, and do not use detergents and cleaners, all of which cause Plaintiff to have nausea, fatigue, headaches, and rashes. Plaintiff further wears clothing made of natural fibers.

*7 Two years ago, Plaintiff and her husband bought a house in Lakeland, Florida, and within the last year, Plaintiff has spent about half of her time there with her husband and half of her time in Deland with her mother. Her husband testified that she continues to improve. She has more energy, is able to help more around the house, and seems happier now. However, Mrs. Barrow testified that her daughter's personality has remained changed; she now has few friends, has little energy, and finds it difficult to be in large groups.

Plaintiff testified that she has felt better after the explant and is able to walk for short periods of time. Additionally, she tries to follow a strict diet with emphasis on natural foods. She is not able to model [FN59] or to fly [FN60] and has not found a career for the future. However, she described herself as a fighter and stated that she has not given up hope that she will find something that she is able to do.

FN59. Cassandra Carrigan testified that Plaintiff had all the qualities to become an international model: she was disciplined and intelligent, had personality, good health and stamina, and was beautiful.

FN60. Mr. Artemis Keitt Darby, III, an expert in piloting and career potential in aviation, including earnings, testified that from his examination of Plaintiff's flying record, including her commercial multi engine rating, her class I medical certificate, and her hours of flying time, her membership in flying related organizations including the Aircraft Owner Pilots Association and the Civil Air Patrol, her college credits, and her contacts with a local charter airline company, that Plaintiff had made above average progress and had the means and desire to achieve her goal to become a professional pilot with a major airline. Darby opined that Plaintiff's lost income from her inability, due to her physical problems, to attain this goal of being an active pilot for an airline from age 32 until age 60 with a life expectancy of 80 years was $5,479,700. Mr. Iver Johann Anker, a pilot who owned a charter airline business and practiced flying with Plaintiff during 1991 and 1992, testified that Plaintiff could have been hired by his company as a first officer or co pilot of a Lear jet at $150 per day for each day flown based on his observation that she was a very skillful pilot and because of her outstanding people skills. Her above average progress toward becoming a pilot was also confirmed by Mr. James Foster Wallace, Plaintiff's flight instructor in multi-engine aircraft systems during 1991 and 1992. He testified that Plaintiff took her commercial single-engine check ride and her multi-engine instrument check ride tests on the same day, which he felt was quite an unusual undertaking and was accomplished by only a small percentage of students. He stated that Plaintiff was very determined to be a pilot, that he would rate her above average in abilities, and that she definitely "had what it takes" to become a pilot. He also noted that, on occasion, Plaintiff indicated that she was not feeling well and had canceled her training lessons at times because of this. Darby noted that because they are in such a minority among the population of commercial airline pilots as a whole, qualified female pilots are in great demand and can expect to be given preference in the competition for hiring. He also stated that while the major airlines used to obtain most of their pilots from the military, now they are looking at civilian pilots who often have several thousand fewer hours of flight time, with minority pilots, including females, having a two times greater chance of being hired than the general population of civilian pilots.

Plaintiff filed an application for Social Security disability benefits on November 24, 1994 and was approved for Social Security disability payments on February 22, 1995. [FN61] She has continued to receive such disability payments since that time. [FN62]

FN61. Dr. Campbell diagnosed Plaintiff as having silicone related connective tissue disorder during the Social Security application process. Plaintiff's Exhibit 1.81(a). He testified that Plaintiff cannot fly an airplane with her condition and cannot be a model. Dr. Houston also participated in the Social Security application made by Plaintiff and testified that receiving Social Security disability payments was a way for Plaintiff to regain her self respect, to have her own income, and to contribute financially in her marriage. She reported that Plaintiff had used these funds to pay the closing costs on a new house for herself and her husband. Dr. Houston's letter to the Social Security Administration is Plaintiff's Exhibit 1.97(a).

FN62. Defendant's Exhibits 1246, 1248, 1249, & 1232.

The evidence is insufficient to persuade the Court that Plaintiff suffers from anorexia or bulimia [FN63] or that her long-term physical and emotional problems occur or occurred because of a fondling incident by a Federal Aviation Administration ("FAA") physician [FN64] or that her problems stem from hypochondriasis. [FN65]

FN63. Dr. Gaffney testified that he treats anorexics who have a mental image of themselves as being overweight and whom he refers to others for psychological counseling. However, he did not feel that Plaintiff was an anorexic and did not refer Plaintiff for psychological counseling. His notes reflect that Plaintiff often complained about how low her weight was and stated that she wanted to gain weight. Similarly, Dr. Jahagirdar testified to Plaintiff's weight loss and gain, noting that Plaintiff always wanted to gain weight and was concerned about weight loss. Dr. Campbell testified that Plaintiff weighed 98 pounds on May 12, 1994 when he saw her after the explant and that her health had declined. He explained that her malnourishment was caused by the sores in her mouth which made eating difficult, and that when she did eat, it was more difficult for her body to absorb the food normally due to her stimulated immune system which was having difficulty fighting her other problems. In his view, Plaintiff always wanted to gain weight, and he did not diagnose her with an eating disorder. He noted that she had improved when she had gone to a spa where her nutrition was more balanced. He expressly rejected Dr. Klein's diagnosis of anorexia nervosa, stating that he had referred Plaintiff to Dr. Klein, a gastroenterologist, whom Dr. Campbell testified did not have the expertise to make this diagnosis and wanted to refer Plaintiff to a relative who was a psychiatrist in Tampa, Florida. Similarly, Dr. Houston stated that she assessed whether Plaintiff's weight loss was self-induced and found not only that there was nothing to indicate this but also that just the opposite was the case, that Plaintiff wanted to gain weight, that Plaintiff had no image of herself as being overweight, and that an eating disorder should be excluded as a diagnosis. Dr. Caldwell agreed that the lesions and ulcers seen by other physicians on Plaintiff's visits could interfere with eating, and he testified that he did not believe that Plaintiff attempted to voluntarily achieve the unusually low weight recorded by Dr. Campbell. He testified that Dr. Klein’s final diagnosis was Irritable Bowel Syndrome with suspicion of anorexia for which he suggested referral to his "brother-in-law". Dr. Caldwell pointed out that no physician seeing Plaintiff more than one time diagnosed anorexia, and he did not diagnose Plaintiff as having anorexia. This assessment was corroborated by Dr. Wadsworth who testified that he could not confirm anorexia as part of his differential diagnosis of Plaintiff's symptoms and signs. Deposition of Wadsworth at 19. In addition, Dr. Lebiod a, who saw Plaintiff only once, testified that his records show concern with bulimia, but that it was not included in his impressions, nor did he diagnose Plaintiff as having bulimia. Deposition of Lebioda at 45 & 52. He preferred to stay within the area of his expertise, gastroenterology. Id. However Dr. Klein, also a board certified gastroenterologist in Texas, saw Plaintiff three times, on June 16, 17, and 20, 1994, on referral from Dr. Campbell. Deposition of Klein at 8 & 17. He diagnosed anorexia nervosa, a psychiatric disorder, and gave her his brother's name and address, recommending she start psychiatric therapy. Id. at 14-17 & 49.

FN64. Dr. Houston initially treated Plaintiff four times in 1992 for symptoms resulting from an unauthorized fondling by an FAA medical examiner during a medical examination which was required for Plaintiff to obtain her pilot's license. Dr. Houston then diagnosed Plaintiff as having major depression, single episode, and also post-traumatic stress disorder, noting that Plaintiff expressed a number of depressive symptoms which were more acute than chronic, and that she did not appear to be biologically depressed since childhood. However, Dr. Houston felt then that Plaintiff's depression seemed "out of line" with this incident, and Dr. Houston could not discern an explanation for this. When Plaintiff returned for treatment in October of 1994, Dr. Houston viewed it as an opportunity to investigate an underlying morbidity. Dr. Houston's diagnosis based on her treatment of Plaintiff from October 1994 until April of 1997 was that Plaintiff had a major, severe depression based on an underlying medical condition from silicone poisoning.

FN65. Dr. Caldwell testified that one reason he diagnosed Plaintiff as having hypochondriasis was the fact that she listed 85 complaints on the Multi-District Litigation Panel form, although when he examined her she did not then say that she had all of these complaints. He stated that the "incredible" list on this form indicated that her problems are psychological, not organic or physical in nature, and since they involved different body systems, did not fit into one disease. However, Dr. Kotzin, an expert in immunology presented by Defendant, testified that he had other patients with symptoms similar to those of which Plaintiff complained. >From review of the evidence and the demeanor of the witnesses, the Court determines that the visits to the variety of physicians were sincere attempts by the Plaintiff to find the cause of, and treatment for, the many, real physical problems from which she suffered, and were not manifestations of hypochondriasis as Dr. Caldwell opined. Dr. Caldwell testified that many of Plaintiff's complaints, such as rashes, Irritable Bowel Syndrome, sore throat, loss of hair, and pain and stiffness in her neck, had occurred before she had implants. In his reference to these as intermittent problems he glossed over the severity of many of Plaintiff's physical problems, which appeared over time after her implant procedure, many of which became chronic, and which are documented in the records of several physicians who treated Plaintiff as a patient. Dr. Caldwell's diagnosis of Plaintiff was that she: (1) has mild depression, (2) has probable significant hypochondriasis, the symptoms of which are psychologically, not organically, induced, and (3) does not have immune disfunction or systemic disease. The determination of "probable significant hypochondriasis" was based on Dr. Caldwell's observation that Plaintiff was overly concerned with her bodily functions, was not compliant, "doctor- shopped," had what he felt was an unusual, bizarre relationship with her husband, and had some social disorders. Dr. Caldwell stated that he did not diagnose the etiology of the Plaintiff's depression, which he felt pre- existed her implants, although he had read Dr. Houston's testimony that the loss of her breasts and inability to work in her chosen career were some of the reasons for the depression. Before he rendered his diagnosis, Dr. Caldwell did not discuss with Plaintiff her emotional feelings about the state of her breasts at the time of his examination of her or the reason that she did not live full-time with her husband, which he described as an abnormal relationship. He testified that he did not decide if loss of her breasts was sufficient trauma to cause Plaintiff's depression. Dr. Caldwell appeared to have approached his examination of Plaintiff with the purpose of reaching his already firmly formed conviction that there was no relationship between silicone gel breast implants in women and immunological problems or systemic disease. Dr. Caldwell examined Plaintiff on one day for a total of 24 minutes and read, not completely accurately as cross-examination showed, her medical records. Although highly published in peer reviewed articles in his areas of expertise, Dr. Caldwell has written only once on silicone gel breast implants, an editorial which was not a scientific essay and which appeared in the Florida Medical Journal in 1994. This editorial was not peer reviewed and represented his personal view that there was no association between such devices and connective tissue disorder. As he testified, he wrote the editorial because he was upset because he felt the statistics which claimed there was a relationship between breast implants and collagen connective tissue disease were so poor. Dr. Caldwell testified that before Plaintiff was examined by him he believed, and now still believes, that silicone does not cause a disease.

B. DEFENDANT'S SILICONE GEL BREAST IMPLANT

Silicone is a term used to refer to thousands of compounds belonging to hundreds of classes with diverse uses in its forms of liquid, powder, solid, or gas. It can be toxic to not toxic, hydrophobic to hydrophilic, inert to reactive. Silicone is a man-made polymer and thus is distinguished from silicon, the element [FN66]

FN66. Silicon is an element just below carbon on the periodic table with chemical properties analogous to those of carbon. After oxygen, silicon is the second most common element within the earth's crust. But silicon is not found by itself in nature. It is found predominantly in the form of silicates and silica and most commonly appears in compounds containing oxygen; it is in rocks and sand.

Dr. David Franklin Williams [FN67] described how the development of the family of silicones in the 1930s to 1940s quickly resulted in the development of medical products because tests showed that silicones were low in toxicity and relatively inert. Thus, in the 1950s silicone was used in tubes, catheters, and hydrocephalic shunts, and its use was expanded to soft tissue reconstruction of the face, to reattach detached retinas through fluid injection in eye surgery, and for the development of artificial skin for repair of burns, wounds, and chronic ulcers. [FN68] Dr. Williams reported that the first clinical use of silicone in breast implants was in 1962 by Dow Corning. Silicone was chosen for breast implants because it had been widely used successfully for medical devices, it could be made to be soft and flexible, and the combination of silicone gel, giving softness and flexibility, within the silicone shell, giving the gel shape, provided a level of performance that could not be obtained from any other combination of materials.

FN67. Dr. Williams, who was qualified as an expert witness in materials science and biomaterials, has received many prestigious awards and honors for his work on materials used in the construction of medical devices. His curriculum vitae is Defendant's Exhibit 1162. He has published over 250 scientific papers and been involved as author or editor of 30 books. He has acted as a consultant in countries throughout the world and has been retained since 1993 as an expert by Defendant BMS, earning between $250,000 and $300,000 for his work as a consultant and expert witness in breast implant litigation. Dr. Williams has spent 30 years researching medical products and devices, including silicone devices, testing them for biocompatibility, or the interaction between the body and biomaterials. However, his work with silicone has been primarily with elastomers, and he has not worked with silicone gel or fluid. He stated that since silicone gel, fluid, and elastomer are based on the same polymer structure and chemistry, he felt that he could extrapolate from his experience with the elastomer in testifying about the silicone gel breast implant. He has neither addressed a professional seminar nor spoken to the United States Food and Drug Administration ("FDA") with reference to his opinions expressed at trial on the silicone gel breast implant.

FN68. In the latter, the skin cells of the patient are grown in the laboratory on a silicone elastomer sheet. The new skin is placed face down on the skin with the silicone elastomer on top. After the new skin forms and heals, the silicone elastomer is peeled away.

In 1969, Wilfred Lynch, who had developed an expertise in plastics engineering and had become involved with silicones in the 1950s when it was a fledgling industry, formed Defendant MEC in order to manufacture and sell products made from silicone. [FN69] Incorporated in the State of Wisconsin, MEC did business under the name of "Surgitek" in the designing, engineering, and selling of breast implants and other medical products. During the first three years of MEC's existence, Lynch designed and selected the materials for MEC's breast implants. The silicone gel breast implant was manufactured in 1970 under Lynch's tutelage, and MEC began selling it commercially in late 1971. [FN70]

FN69. Lynch also taught courses in silicone chemistry at the University of Wisconsin and holds a professional engineer's license in that state. He has written a 1976 book entitled "Handbook of Silicone Rubber Fabrication" which became a "bible" of the industry, and included printings in Japan and China. In the late 1980s, he authored a book entitled "Implants: Reconstructing the Human Body." His occupation at age 78 is working as a consultant in the applications of silicones to medical devices. Deposition of Lynch at 2394-2403.

FN70. Deposition of Lynch at 2909; Plaintiff's Exhibits 2.214 & 2.212.

*8 In 1973, Lynch sold his interest in MEC to David Sanders who then became MEC's president while Lynch became an MEC employee for three years. Thereafter Lynch entered into contracts with MEC and worked as a consultant for the company for approximately twelve years. [FN71]

FN71. Lynch also acted as a consultant for another subsidiary of Defendant BMS named XOMED. Lynch has been an expert witness for BMS and MEC in lawsuits involving breast implants.

Lynch gave extensive testimony at trial concerning the manufacturing process and the tests performed by MEC on the components of its silicone gel breast implants and the finished devices during the course of the manufacture and sale of such devices. In addition to the testimony of Lynch, Defendant's witness Dr. John Martin Zeigler [FN72] and Plaintiff's witness Dr. Pierre J.J.B. Blais [FN73] gave detailed descriptions from the trace cards and lot histories of Plaintiff's implants of the process for MEC's manufacture of a single-shell, gelfilled breast implant of the silicone variety.

FN72. Dr. Zeigler, an expert witness in chemistry, silicon chemistry, materials science, failure analysis of polymers, and crystallography, holds a doctorate in organic chemistry and worked on silicon-based polymers for over 8 years with Sandia Laboratories. Dr. Zeigler holds 24 patents on silicon polymers and silicon gel, 11 of which are in the United States. He has published articles on silicon polymer chemistry and authored a book entitled "Silicon Based Polymer Science." Defendant's Exhibit 1255. He presently commercializes materials he has patented for his own company, serves as a scientific and legal consultant, and markets a software program which he has developed. He testified that he spends about 30% of his time in litigation, has testified in 6 cases, and has consulted with Defendant's attorneys since 1993. Dr. Zeigler testified that he has examined about 350 silicone gel breast implants and explants, including Plaintiff's explanted devices, mostly for MEC. He examined Plaintiff's explants on June 4, 1997, and prepared a report dated November 16, 1997. He has never been a consultant for plaintiffs.

FN73. Dr. Blais holds a doctorate in polymer chemistry and owns several patents in the medical device field. He has published in a peer-reviewed text on breast implant techniques and the application of industrial trial materials to implants. He was qualified as an expert to testify in the areas of polymer science, chemistry, crystallography or the geometry of molecular assembly, and the design defects and failure analysis of medical devices, including silicone gel breast implants. Dr. Blais worked for 13 years in the Canadian Bureau of Medical Devices, Department of Health and Welfare, where he examined retrieved devices, including breast implants, for clinical merit. In 1979, he proposed that all devices implanted for a period lasting over 30 days be required to obtain premarket approval. His recommendation was enacted into law in Canada on April 1, 1983. Dr. Blais left his post with the Canadian government in late 1989 amid controversy about which he was extensively cross-examined during trial. Since then, he has continued work with polymers and teaches polymer chemistry and the pathology of tissues interacting with artificial substances, among other subjects. He testified that he has examined 7500 to 8500 breast implants from over 4600 persons and has extensively studied MEC's documents. He has been an expert for plaintiffs in breast implant cases since 1983.

In 1976 when MEC began using Dow Corning products for its breast implants, it received the shell and gel in kits sold in metal cans containing the numbered product lot, claims of suitability, and instructions, including expiration date and conditions of use. MEC then mixed and processed the components and added its own components, such as zinc stearate to help remove the shell from the mold. [FN74] It then marketed its breast implants to physicians accompanied by a package insert.