Melinda Barrow 7

FN147. Id. at 2063.

FN148. Id. at 2065.

FN149. Id. at 2066. In a letter dated April 23, 1980, Lynch wrote as a consultant to MEC: Any mammary prosthesis should be handled with great care because the shell material, although it is strong and stretchy, has low tear strength and once it is nicked or scratched or subjected to unusual strain while forcing through a small incision, can easily split at the time of surgery or later during a patient's hyperactivity or an impact to the breast. This would be the case whether, within the acceptable range of thickness of mammary shells, the shell is thick or thin. On the other hand since the shell will have folds in it after the device has been placed in the patient and continuous flexing will take place at these folds due to the activity of the patient, we feel the thinner shells have a twofold advantage; there is less chance of palpating the folds and the flex life should be longer because the thicker the material the higher the stress at the fold. Plaintiff's Exhibit 8.42.

I don't think anybody in the business at that time, including surgeons, fully realized the amount of motion of a breast, you know, during the course of a day, walking and jumping and dancing and that sort of thing. [FN150]

FN150. Deposition of Lynch at 2066. According to Dr. Zeigler, MEC did tests to establish when gel bleed reached equilibrium and found the time was two to three days in an undisturbed implant. MEC's technical study in 1980 on mastication measured the effect of handling on the properties of silicone gel. It was not a study to determine the effect on the implant when there is movement in the human body. See Plaintiff's Exhibits 2.84, 5.48, & 5.73.

Lynch admitted that motion of the breast could affect gel bleed.

Nevertheless, MEC conducted no tests to determine the effect of breast motion on its implants in the human body. [FN151] Lynch admitted that he did not know if MEC's sales representatives told doctors that the implants would last the lifetime of the patient and stated that this statement, if made, would be a misrepresentation. [FN152]

FN151. Deposition of Lynch at 2067-69.

FN152. Id. at 2070-72.

Lynch testified that MEC did not fund a study to look at the immune response of women implanted with its breast device. At least one MEC employee responsible for conducting and carrying out tests on implants testified that there was discussion within Defendant of claims that women were getting ill from silicone implants and the possibility that implants caused autoimmune disease. [FN153] However, no tests were conducted by MEC to determine if there was an association between gel bleed and autoimmune disease on the ground that there was too little incidence of such disease to justify a test. [FN154] Such study, Lynch noted, would require thousands of patients and would have to have enough people involved to make a statistical determination of whether the immune system is affected by silicone gel bleed. [FN155] In his opinion this would require two populations, one with silicone gel breast implants and one without such devices. No testing of this nature was done in animals because, according to Lynch, MEC felt it would not be able to find an exact animal substitute for the human.

FN153. Deposition of Golwitzer at 46-47.

FN154. Id. at 47. Mr. Golwitzer stated that there was no way Defendant could set up such a test, and he did not know of anyone who contacted an expert to do such test. Id.

FN155. See supra note 99.

*16 Dr. Kenneth Scott McCarty, Jr. [FN156] testified that in 1991, when silicone gel breast implants were removed from the market, immuno-potential tests had not been done. The 1991 application for approval to market a silicone gel breast implant made by MEC to the FDA was rejected for lack of proof of safety. MEC had opposed reclassification of silicone gel breast implant devices from a Class II to a Class III device which would require premarket approval by the FDA. [FN157] Over the objection of manufacturers, including MEC, the FDA did reclassify these devices and, in 1991, identified potential risks for MEC to address before approval to market them would be granted. [FN158] The FDA then determined that there was insufficient documentation provided by MEC and withheld approval of the devices for sale except in limited circumstances, such as for breast reconstruction following mastectomy. [FN159]

FN156. Dr. McCarty, who testified as an expert in pathology and internal medicine with emphasis on endocrinology, is a board certified anatomic pathologist and specialist in internal medicine. His curriculum vitae is Defendant's Exhibit 1149. Dr. McCarty testified that he has examined 15,000 pathology slides on breasts, over 1800 of which were slides of women with implants and about 400 of which involved specimens from breast capsules of women with breast implants. Dr. McCarty has worked for several manufacturers of breast implants, beginning in the 1980s, and has acted as an expert for Defendant BMS since the early 1990s. He has reviewed approximately 30 cases, including review of pathology slides in at least 10 cases involving silicone gel breast implant litigation. Dr. McCarty was vague concerning the circumstances and amount of money he has earned as an expert in this regard. He has neither written a peer-reviewed article nor spoken to scientific groups on silicone gel breast implants.

FN157. Dr. Blais testified that the idea of premarket approval had been developed first in the United States, before Canada considered the proposition, but that the "landscape" in the United States was much more complicated. It was not until 1992 that breast implants came under regulation by the FDA similar to that in Canada, with important exceptions.

FN158. In his testimony on this subject, Dr. Williams referred to Plaintiff's Exhibit 9.104. According to Dr. Williams, the FDA asked MEC, among other things, for molecular weight distribution of gel precursors and an analysis of volatile and nonvolatile residual compounds. He did not see compliance with this request within MEC's documents.

FN159. In the opinion of Dr. Williams, there was adequate documentation that the silicone gel breast implant was safe and biocompatible, and there was adequate safety information to evaluate the risk of autoimmune response at the time the FDA refused to grant premarket approval. This opinion was given by Dr. Williams at trial, although he conceded that MEC and other manufacturers of silicone gel breast implants made no attempt to follow, in a controlled, clinical manner, women who had received implants to determine if there was an adverse immune response. He stated that he was not aware of any funding by MEC or BMS of an epidemiological study of this issue whether before or after the 1991 premarket approval was denied. MEC simply responded individually to physicians who contacted MEC and undertook neither to follow-up with implanted women nor to send a "Dear Doctor" letter to apprise physicians of the possibility of an autoimmune response to its device.

C. EFFECTS OF MEC'S IMPLANTED SILICONE GEL BREAST DEVICE

Preliminarily, the Court notes that both Plaintiff and Defendant offered testimony at trial from a variety of experts on the issue of the effects of the silicone gel breast implant on the human host. These witnesses can generally be divided into two categories: (1) those who have spent considerable time and attention directed in particular to the study of silicone gel breast implants and the long-term effects of such implants on women, and (2) those who were experts in related fields but who had been retained for this case to review documents and utilize their considerable credentials to render opinions by extrapolation from their respective areas of expertise. The large fees paid to these experts, the length of time many have remained engaged as an expert solely for one side or the other in lawsuits involving silicone gel breast implants, the degree to which some of these witnesses have been subjected to "investigation" by representatives of the opposing party, with resulting loss of position, stature, and/or income, [FN160] and the passionate involvement in the issues in this case some demonstrated from the witness stand makes this case unusual when compared with other trials involving issues of science. It has caused the Court serious question concerning the scientific objectivity and reliability of some of the testimony presented. [FN161]

FN160. Reference is made in this regard to the testimony of Drs. Blais, Puszkin, and Campbell.

FN161. However, in some respects, the testimony of these witnesses on particular scientific matters was not contradictory and, thus, to that extent credibility was not involved. For instance, the testimony of Lynch and Dr. Blais as to gel bleed and gel migration was surprisingly similar.

1. Gel Bleed

It is undisputed that the design of the silicone gel breast implant produced by MEC resulted in gel bleed. It is a play on words to contend that gel bleed was not an "intended" result of the design of this product and the component materials used, although much testimony was presented on this point. [FN162] Virtually all of the knowledgeable experts testified that a silicone-based elastomer containing a silicone gel in a breast implant device would "bleed" by virtue of the chemistry of the shell and gel in juxtaposition to each other. [FN163] As described previously, because of the properties of the silicone gel and the silicone elastomer in relation to each other, lower molecular weight molecules of the gel are attracted to the higher weight molecules of the elastomer, causing the oils in the gel to migrate through the elastomer shell in a phenomenon generally referred to as "gel bleed." [FN164] This causes the shell to swell as the oil passes through it to the outside of the silicone elastomer resting against the human breast tissue. The swelling of the elastomer in turn causes the gel bleed to increase. [FN165] In addition, mastication or massage of the implant, or movement of a breast containing a silicone gel implant, can increase gel bleed. [FN166] As to gel bleed, Dr. Blais testified that as the oil component of the gel carrying impurities bleeds, its composition changes as does the composition of the silicone gel left inside the silicone shell. Further, since many parts of the human body are attracted to oil, the shell with oil in it attracts fatty substances from the body which can be absorbed into the shell and migrate into the gel still held within the elastomer. [FN167]

FN162. For instance, Dr. Alan Shons, an expert in plastic surgery, testified that the silicone gel breast implant "as originally designed was not designed to bleed." This testimony was given without any indication of direct knowledge of this witness of either the manufacturing process or materials science. To the same effect is the testimony of Dorothy Povkovich, employed by MEC variously as a regulatory affairs analyst, document writer, and supervisor since April of 1978. Deposition of Povkovich at 12-13 & 136-39. While there was no testimony that the originator of this device wanted an implant that would bleed silicone gel, there is no question, as Mr. Lynch himself testified, that he and the Defendant manufacturer knew at the time the silicone gel breast implant was designed and manufactured, as well as at all times when the device was placed for sale in the market, that the implant would bleed gel by virtue of the properties of its component parts. Lynch testified that while he did not have the goal of designing the shell of the MEC breast implant to bleed gel, or the goal of designing it to fail because it would allow the gel material to escape, he knew the silicone gel from the implant would bleed through the shell because of the design he chose and the components used by MEC to make the device. Deposition of Lynch at 2721 & 2730. To like effect was the testimony of Dr. Williams who stated that while gel bleed was well known to MEC, the implants were not designed in order for them to bleed; the concept was to design the implant to give it shape by the shell, not to contain the gel. On cross-examination, Dr. Williams admitted that he had not looked at the properties of the ingredients in the Dow Corning gel used by MEC and, further, that materials which are satisfactory for use by themselves may be unsatisfactory when used in combination with other materials in a medical device. On the other hand, Dr. Zeigler noted that by selection of the materials used in Plaintiff's implants, MEC incorporated into the design the factor that the elastomer would be permeable to other silicones.

FN163. As noted previously, Lynch, founder of MEC and designer of the breast implants which it sold, described this phenomenon during his deposition. Dr. Zeigler testified that if a soft material breast implant is desired, there is no way to incorporate a soft material, including silicone, and not get fluid permeation. Dr. Blais and Lynch disagreed. MEC developed SCL "A," a silicone gel breast implant that was marketed by MEC as having less gel bleed, at the time Plaintiff received her implants. MEC also developed and marketed a saline-filled breast implant.

FN164. Dr. Blais testified that gel bleed is a vernacular term for what is more properly described as leakage of the gel. Dr. Christopher David Batich, who received his doctorate in organic chemistry at Rutgers University and who qualified as an expert in material science and chemistry with emphasis on silicone chemistry, gave a simplified explanation of gel bleed of low weight molecules of the silicone gel through the silicone elastomer which he said is more properly described as permeation, osmosis, or diffusion.

FN165. Dr. Blais explained how the additives to the manufacturing process affect the bleed of the gel. For instance, he noted, the zinc stearate added to remove the shell from the mold is a wax mixed with a paint-like solution which is washed away when the shell is removed from the mold, leaving holes in the shell which in turn increase the amount of gel bleed. He contended that the bleed also carries with it metals from the catalysts used in the manufacturing process which then penetrate the shell to its outer side. While describing gel bleed as permeation, or the movement of molecules of low weight through the implant membrane under the influence of the concentration gradient, whereby more molecules remain inside the membrane than outside of it, Dr. Zeigler disputed that chemicals added in the manufacturing process had any affect on gel bleed. Instead, he stated that gel bleed occurs because of spaces in the elastomer and because there is more of the permeating material inside the elastomer than outside of it.

FN166. Much testimony was produced on this point. Gary A. Golwitzer, an MEC employee responsible for testing, testified that MEC knew gel bleed caused the elastomer to become softer and that MEC had found that the cohesion of the gel changed with manipulation during a ten-minute massage test. No other manipulation tests were done by MEC. Deposition of Golwitzer at 40-41. Several witnesses, including Lynch, Dr. Zeigler, and Dr. Blais, discussed the concept of equilibrium of gel bleed. Dr. Blais testified that if the silicone gel breast implant was left undisturbed for a period of time, around 15 days, the gel bleed would equalize and stop. Dr. Zeigler testified that MEC tests showed equilibrium, or the point at which gel bleed will cease coming through the shell, was reached in 2 to 3 days. However, in the body, this condition is not achieved because of movement of the human which affects the breast. Dr. Batich conducted a test in which a silicone gel breast implant was put into a container of simulated body fluids consisting of salts and water and was subjected to a gentle rocking motion. He found that at first there were different levels of gel bleed, and then the bleed settled down to .7 mg. every 2 weeks or about 18.2 mg. per year and .05 mg. per day, an amount he felt was significant, particularly since he found that gel bleed was continuous. Further, Dr. Blais testified to a mastication technical study done in 1980 which reflected that silicone gel, if moved, lost its properties and quickly produced oils. Plaintiff's Exhibit 2.84. If the handling ceased, some but not all of the gel restored its properties. Dr. Blais left one of Plaintiff's implants on the top of the laminated witness stand during his testimony, and upon its removal, a residue was clearly visible. He testified that simply leaving the silicone shell on a surface and waiting for it to bleed is not honest to the human situation. When questioned whether massage caused gel to lose cohesivity in an implant, Dr. Shons stated that he did not know what cohesivity meant. Dr. Zeigler was critical of the experiment related by Dr. Batich, stating that Dr. Batich's attempt to show degradation of the surface of the elastomer was flawed because he used an elastomer that was different from that used in a breast implant, treated the elastomer with strong oxidizing reagents which are not found in the human body in significant quantity, and failed to show that hydrolysis had occurred. Dr. Zeigler opined that not only does the published literature not support the position that the silicone elastomer degrades at the surface and the silicone molecules become water loving, but also he stated that pressing on an implant would cause only a small increase in gel bleed which is not measurable, does not change the viscosity or thickness of the gel, but does change the cohesion or ability of the gel to stay together in a single mass. He also acknowledged that MEC's mastication tests showed a change in the gel cohesion, and to the extent material is removed from the surface of the elastomer, it would be replaced by gel from the interior, upsetting the equilibrium. Dr. Zeigler was critical of agitation tests which showed "steady state bleed" because the tests were conducted on a roll mill which constantly removed material from the surface of the elastomer and did not replicate the body condition. Dr. Zeigler was also critical of the filter paper test used to demonstrate gel bleed on the ground that equilibrium would not occur because the filter paper is like a wick, removing the gel material, and the situation was not indicative of what happens in the body because it was not in an aqueous environment. Nonetheless, he admitted that a closed capsulotomy or excessive handling of the implant caused reduction in gel cohesion, although this is not irreversible since cross linking recurs if the implant is allowed to rest about 14 days. Dr. McCarty was also critical of the filter paper tests on the ground that filter paper acted like a wick. He opined that closed capsulotomies did not increase gel bleed because they do not involve persistent enough pressure, although he admitted that he and his colleagues had never performed such technique. Dr. Williams testified that he had seen MEC documents showing that silicone gel did break down from handling or massage, but he was uncertain if MEC equated handling with massage. Dr. Williams did concede that whether a material breaks down in the body is important to its use because the body is a harsh environment.

FN167. Dr. Blais called this the "partition equation" or an exchange. Dr. Batich concurred that body fluids permeate inside the elastomer shell and the gel it contains. Dr. Puszkin also testified that not only do silicone gel implants bleed, but also the body contributes molecules to the gel inside the shell. Since the body creates negative and positive pressure on the chest, things go in and out of the elastomer in the chest, Dr. Puszkin explained. Further, if the elastomer shell is put on a desk, barometric pressure can cause gel bleed. Dr. Zeigler testified that atmospheric pressure affects only slightly the rate of equilibrium but not the amount of gel bleed in reaching equilibrium.

*17 While gel bleed was not a desired result or a goal of the design of MEC's silicone gel breast implant, it was well-known at the time such breast implant was designed and sold to physicians, as Lynch testified that silicone gel placed inside the silicone elastomer shell resulted in the phenomenon of gel bleed in all such breast implants. [FN168] Further, Dr. Brian Kotzin [FN169] testified that he was not familiar with any biological mechanism by which a person exposed to gel bleed could eliminate such exposure from her body and, further, that such bleed would continue, not necessarily at the same rate, for the entire time the silicone gel implant was in the woman's body. [FN170] Thus, as noted during an FDA hearing on the device, the silicone gel breast implant manufactured by MEC acted as a slow delivery system of silicone gel when placed in the human body.

FN168. See also Plaintiff's Exhibits 3.273, 3.220, & 3.248. There was testimony from Lynch and Dr. Blais that breast implants could have been designed at the relevant time without gel bleed occurring, for instance with the use of a saline solution instead of silicone gel as the filler within the elastomer. Lynch testified that the first implant he designed used a material that did not bleed. Dr. Blais testified that a gel could have been made that would not change. According to Blais, at the time Plaintiff was implanted in 1985, MEC had begun selling the SCL "A" (strong cohesive low-bleed series) breast implant, consisting of a shell with an extra coating of a different material to seal holes and to lessen gel bleed. Dr. Williams, in contrast, stated that it is not possible to create in a breast implant a sufficiently flexible membrane which is totally resistant to diffusion.

FN169. Dr. Kotzin is a practicing physician in rheumatology and internal medicine, a professor, patent holder, and an acclaimed researcher who with others has published over 125 peer-reviewed papers focusing on how people develop connective tissue disease and the genetic predisposition and immunologic means by which autoimmune disease is developed. Dr. Kotzin's curriculum vitae is Defendant's Exhibit 1146. He was qualified as an expert witness in internal medicine, rheumatology, and immunology. Although Dr. Kotzin has not previously testified in a silicone gel breast implant case, he has been designated as an expert witness by BMS in approximately 30 cases since 1996. He has earned approximately $80,000 a year for each year, 1996 and 1997, for his work for BMS. He has not published or presented a paper or lecture to a scientific group on silicone gel breast implants or related disease(s). Excluding referrals from breast implant manufacturers, only 15 to 20 of his patients have silicone gel breast implants. He also testified that neither his research nor his laboratory dealt with silicone polymers.

FN170. According to Dr. Blais, the Surgitek 1500 type implants placed in Plaintiff were manufactured by MEC in the mid-1980s and contained other defects in addition to gel bleed. For instance, the shells were full of microscopic holes which were large in relation to the silicone oil and furthered the gel bleed process. The shells had too much surface area, causing the shell of the implant to fold back on itself, primarily around the implant rim and the implant patch. The folds repeated in the same place, causing a buckling. Dr. Blais found 10 different pleats or folds on the rims of Plaintiff's implants, with more severe pleats being found on her left implant. He found the gel in one implant to be more fluid than the gel in the other and testified that the imprinting of the patch had caused the elastomer material to stretch and deform, thus opening up microscopic holes for gel bleed to occur against Plaintiff's nipple. Dr. Blais described Plaintiff's implants as being "glossy," or showing a significant rate of oil effusion readily visible to the naked eye. He noted that the implants were not matched, a factor which does not appear to have relevance to the claims in this case as he stated they were of the same size and issued from the same mold. He also stated that there was a long delay between the manufacture and the implant of the devices into Plaintiff and that the shells were worn in a way "typical of the age and low activity" of the Plaintiff. Plaintiff denied that she was a person of low activity during the major portion of the time during which she was implanted. The Court does not include these as defects in its findings of fact, either because they were not supported by the evidence, such as violent imprint of the patch, or they are irrelevant to the Plaintiff's claims.

2. The Foreign Body Reaction

After an implant is surgically inserted into the human body, a response known as a "foreign body reaction," a response of tissues to a foreign body, occurs. [FN171] This is an acute inflammatory response achieved through different cells, predominately macrophagia, which try to consume the invader, and, if unsuccessful, will wall out and store the foreign body or cause it to be pushed out if it is close to the skin. When a silicone gel breast implant is put into the human body, a tissue, called a capsule, is formed as part of the foreign body reaction. [FN172]

FN171. Several witnesses discussed the foreign body reaction and this phenomenon in the context of an implanted silicone gel breast device. For instance, Dr. McCarty, stated this is a process whereby a monocycle enters into the tissue from the blood circulation and becomes a histiocyte, or tissue monocyte or macrophage, which develops vacuoles, or a membrane delimited space within the cell, to contain the debris of anything foreign which it is trying to clear from the body. If the foreign body is something which the macrophage cannot digest, several macrophage cells can fuse, forming multinucleated cells which have a foamy appearance and also are sometimes called foreign body giant cells. Together the foreign body giant cell, other histiocytes, and macrophages will stimulate fiberblast cells that deposit collagen and store whatever cannot be eaten, consumed, or recycled, forming the capsule. If fusion does not occur, the cells are often referred to as foamy histiocytes. Dr. Williams noted that the acute inflammatory response which occurs with any implant is the initial stage of the foreign body response. Dr. Kotzin further described how the arms of the immune system have the capability to recognize and discriminate between foreign bodies and the normal cells of the human body. He related that the body's T-cells help its B-cells by attacking cells with the foreign body, such as a virus, to try to remove them from the body. The T-cell has a receptor which can reach out and recognize foreign matter chopped up in a presenting cell or macrophage. The B-cells make antibodies, soluble proteins which travel throughout the body to target whatever is to be recognized, such as tetanus. To have a good antibody response, the B-cell needs help from the T-cell to make antibodies. Both are necessary. If the body does not have a good antibody response, it will develop infection or other problems. Dr. Kotzin explained that there is no scientifically valid study to show that T-cells can recognize silicone in anyone. Therefore, he testified, the symptoms of women with silicone gel breast implants are unrelated to T-cell immunological responsibilities or an antibody related immune response. Further, silicone consumed by a macrophage, the presenting cell, cannot be chopped up and presented for the T-cell to bind to it. According to Dr. Kotzin, it is chemically unlikely that this would happen, and there is no evidence that T-cells go to the area of the breast implant because they recognize anything. He also represented that there is no reliable evidence that T-cells proliferate in response to silicone products. He dismissed as unsupported the contention that an autoimmune response involving T-cells and B-cells occurs in women with silicone gel breast implants, stating that no study shows this to occur and the theory does not take into account the way a T-cell recognizes a protein. Furthermore, if this occurred, he stated it should be identified as occurring in the capsule, but no study shows this to have happened.