Melinda Barrow/11

*24 However, Dr. Kotzin conceded that at times doctors determine the etiology or cause of a disease in the absence of epidemiology or the study of association. Also, not all persons exposed to a cause of disease get that disease; for instance, not all smokers get lung cancer. He admitted that the manufacturers of silicone gel breast implants did not rely on epidemiology when they represented that such devices were safe, nor did they propose epidemiology to study issues of contracture, gel bleed, rupture, or rheumatical complaints in women who had received silicone gel breast implants. He acknowledged that it can take years to move from a bedside diagnosis to the listing of a disease in an authoritative textbook, and when scientists dispute among themselves the cause(s) of a new disease, a proposed cause which was earlier rejected may ultimately become the generally accepted view. Further, case reports can establish diseases for which no epidemiology then exists and did so for thalidomide malformation, vinyl chloride and cancer, and vaginal cancer in DES offspring before experts in the field accepted the results or epidemiological studies established the association. Case studies, not cohort studies, are also used in establishing a rare disease, and he admitted that a study of the association between silicone gel breast implant and all CTD could mask the occurrence of a rare disease. [FN225] He admitted that no epidemiological study has been done which looked for the constellation of symptoms of Human Adjuvant Disease, although he has read case series and reports which show the relationship between silicone gel breast implants and a constellation of symptoms of disease. [FN226] However, Dr. Kotzin discounted a search for diseases where the causes were established by case reports in the absence of epidemiology. [FN227]

FN225. Dr. Kotzin acknowledged that it would be inappropriate to dismiss case reports as being of no consequence and admitted that he had not seen case reports that a patient had improved after explant. He added that no one has studied whether patients whose silicone gel breast implants have been explanted get better, and this could be an important study.

FN226. Dr. Kotzin further elaborated that to have an immune response, cytokines release molecules of protein to communicate with other cells in the area of the inflammation. A large number of cytokines can make a person feel badly and can be measured in the blood. A sedimentary rate ("SED") test can determine if the release of cytokines is due to systemic inflammation which causes the molecules of protein to migrate into the blood stream (and thus the red blood cells to group and fall faster in the test tube during this test.) The SED rate usually goes up when there is release of cytokines due to systemic inflammation. The C-reactive protein ("CRP") test, a more sophisticated test, is a general screening test for underlying proteins. Then there are tests to discern if there is a certain type of protein being issued or if the number of cytokines has gone down. However, Dr. Kotzin stated, no study suggests the SED rate test is elevated in persons with silicone gel breast implants who have complaints of systemic disease. Plaintiff's SED rate was normal and did not suggest systemic release of cytokines or systemic inflammation. In fact, no test done on Plaintiff suggested systemic release of cytokines or systemic inflammation according to Dr. Kotzin. Thus, he concluded there is no documented evidence of systemic release of cytokines in silicone gel breast implant patients, and the evidence suggests that this does not occur. Also, Plaintiff had a serum protein electrophoresis test which measured monoclonal gammopathy ("MOGUS") not B-cell proliferation. The results of this test were normal in Plaintiff, and no controlled study shows that MOGUS is increased in a patient with silicone gel breast implants according to Dr. Kotzin. Therefore, concluded Dr. Kotzin, there is no evidence that silicone can function as a superantigen. However, Dr. Kotzin admitted that he had never done a study on the adjuvancy of silicone oils and gels, and he had never checked the blood of women who had the subject device implanted to see if there was a proliferation of T-cells in response to a silicone gel breast implant. He explained that although his laboratory has the capability to do this, his research and laboratory do not deal with silicones. Further, he acknowledged that there were published studies in which silicone gel from an implant had been emulsified with a foreign antigen and an adjuvant response resulted. He further admitted that he had not researched the effects of gel bleed, had not determined if emulsification occurs in the human host, and had not analyzed the material between the breast capsule and the silicone gel breast implant in the human host. In contrast, Dr. Busch, who related that he has reviewed thousands of documents incident to breast implants, testified to his view of the immunological effects of migrating silicone which acts as a drug with a powerful adjuvant effect, converting weak antigens into more powerful antigens in the body causing alteration of the immune system, or autoimmune disorder, in humans leading to systemic disease. E.g., Plaintiff's Exhibits 30.120, 3.281, 3.289, 30.653, & 30.504-.505. According to Dr. Busch, an adjuvant is often given with an antigen, a substance or material, chemical or biological, that produces an immune response, to increase the response. He testified that silicone produces an immune response by itself. Freund's Adjuvant is the "gold standard" for the world of adjuvants comprised of extracts of lipids containing materials which, when mixed with antigens, heighten the body's response. Researchers have found that silicone gel is more powerful than Freund's Adjuvant, the world's best adjuvant, according to Dr. Busch. Dr. Solomon concurred that silicone is an adjuvant, stimulating an antibody-making apparatus and activating the autoimmune system. Dr. Solomon cited to the study of Dr. Lencio Garrido using NMR spectrocity to follow silica containing chemicals after the body had been exposed to silicone gel, Plaintiff's Exhibit 1.23S, and Dr. Smalley's work, Plaintiff's Exhibit 1.23t, showing how T-cells respond specifically to silica and silicone gel, to support his opinion. Disagreeing, Dr. Kotzin testified that there is no reliable test to show silicone antibodies, no test for a silicone antibody which has been approved by the FDA, and if a silicone antibody exists, it would be in the blood so that studying the capsule after an explant would not enable one to tell if silicone antibodies were there. Dr. Kotzin testified that no adjuvant, a substance to boost an immune response usually to a foreign protein, has been shown to cause a disease in humans or to be harmful to humans, and almost everyone is exposed to adjuvants. Adjuvants are mixed with the materials to which the response is directed. While silicone as an adjuvant, consisting of gel mixed with fluid and an antigen and then homogenized using a high speed mixer to emulsify, has been found in mice, rats, and guinea pigs, he testified that studies show that an intact gel without an antigen does not function as an adjuvant found in the human body. Dr. Kotzin testified that studies do not show that silicone oil mixed with an antigen, silicone elastomer mixed with an antigen, or gel bleed mixed with an antibody become adjuvants. He concluded that a silicone gel breast implant in a human or in an animal does not create or function as an adjuvant. Further, he opined that there is no evidence of any adjuvant effect in women with silicone gel breast implants, and from his review of the records, there is no evidence of any adjuvant response in Plaintiff. Dr. Kotzin stated that it is biologically possible for silicone to become an adjuvant but only if it is emulsified and mixed with an antigen. He stated the name "Human Adjuvant Disease" is no longer a meaningful term first because an adjuvant does not induce a disease, it boosts an immune response to a foreign antigen, and second because it refers to a disease in rodents which occurs when Freund's Adjuvant is injected. The disease in rodents does not resemble the symptoms reported in women with silicone gel breast implants, and the injection, which includes such matter as dried bacteria and mineral oil and others, does not include silicone. He noted that humans do not get the disease which the rodents got, which he called destructive arthritis.

FN227. As Dr. Kotzin testified, Dow Corning, at least, knew in the 1970s that it was biologically possible for silicone to act as an adjuvant, yet no studies of this phenomenon were done. He testified that it would be appropriate for manufacturers to fund epidemiological studies on the association between silicone gel breast implants and symptoms because the studies are very expensive and very complex.

On cross-examination, Dr. Kotzin appeared to struggle with words and haltingly testified that among reasonable scientists there is ongoing disagreement whether silicone gel from a breast implant can contribute to systemic disease. While he denied that he has seen any evidence to support the contention there is systemic illness related to silicone gel breast implants, he acknowledged that reputable scientists are still studying the question, which means that they have not foreclosed the conclusion that there may be illness related to such devices. [FN228] He admitted that there are reasonable scientists today who believe the question whether silicone gel breast implants are related to systemic disease is not answered.

FN228. On redirect examination, Dr. Kotzin testified to the deficiencies in several studies which concluded there is a relationship between silicone gel breast implants and adjuvancy, systemic symptoms, or heightened T-cell response.

On the present record the Court cannot make a finding that there is a defined disease known variously by such names as systemic silicone disease, ACTD, or SSRD. As noted earlier in this opinion, the greater weight of the credible evidence at trial established that gel migration from the Plaintiff's silicone gel breast implants caused a chronic foreign body reaction which occurred within and beyond the confines of the capsule around the implant in each breast. The particles from the silicone gel bleed which remain in Plaintiff's tissues after explant cause such foreign body reaction to continue. However a preponderance of the evidence does not establish that all of Plaintiff's symptoms are related to gel bleed from the breast implants nor has Plaintiff carried her burden to prove by a preponderance of the evidence that she has systemic silicone disease.

*25 Betty Lock testified that package inserts were the primary vehicle used by MEC to warn physicians of potential complications in the use of its breast implant products. [FN229] She disclaimed the responsibility of MEC to give full disclosure of all complications in the package insert, contending that physicians already had all the information about the implants and that the package insert did not represent that it was a complete list of complications. [FN230] While she knew of gel bleed since the 1970s when she was in sales and could feel the greasiness of the implant, and she had read articles on silicone migration to body organs, nonetheless gel migration was not mentioned by MEC in its package inserts which accompanied Plaintiff's implants. [FN231] Further, Lock testified, the lifetime warranty given in the package insert meant a warranty for the life of the product, and the statement that the implant "possibly" would have to be replaced meant that it "probably" would have to be replaced. [FN232]

FN229. Id. at 214, 1262-63, & 1273-74. Lock testified that MEC did not send "Dear Doctor" letters to advise of problems with its breast implant product and that doctors would have to compare old and new package inserts to be alerted to any revisions, changed information, or warnings about new problems. Id. at 1271-72 & 1279. She testified that the package inserts were changed by MEC "as things came up" and "as they were reordered." Id. at 1447.

FN230. Id. at 1279-80.

FN231. Id. at 1389.

FN232. Id. at 1436. Lock testified that this was just a matter of semantics. Stith testified that nothing in the literature MEC distributed to doctors stated that the implant might have to be replaced on a regular basis. Deposition of Stith at 127-128. There was differing testimony on the life of a breast implant. Dr. Shons testified that when breast implants first appeared on the market, plastic surgeons thought they would last "a good many years ." He felt a reasonable range for the life of a breast implant was 10 to 20 years. Dr. Zeigler testified that with normal activity as opposed to trauma, the breast implant shell would not wear out and would last indefinitely. He related having seen MEC "Dear Doctor" letters which stated the implants would last the life of the patient, and since the general patient population for implants was young in age, this meant that they would last for decades. However, Golwitzer testified that while he thought the implants would last forever, he was not aware of any testing by MEC to establish whether this was true. Deposition of Golwitzer at 68. Stith concurred, stating that while he worked at MEC, he understood that its silicone gel breast implant was designed to last the woman's lifetime. Deposition of Stith at 125-28. Lynch testified that MEC hoped the implants would last the lifetime of the person who received them, but that MEC was not specific about this. Deposition of Lynch at 2727. MEC only guaranteed that the implant would be replaced if it failed; it did not tell people that the implant would have to be replaced in 5 to 10 years or that the implanted woman would have to have new surgery to take the implant out and put in a new implant. Id. at 2727-28. Dr. Blais testified that in his opinion the life expectancy of a silicone gel breast implant for a normal, average person with normal life activity is 10 years based on his study and examination of specimens. For an active person, he opined that the life expectancy is 5 years, and for a sedentary person, the life expectancy is 15 years. Dr. Williams testified that MEC's silicone gel breast implant product was sold for long-term use to last the patient's natural life and that it was predominately sold to young women with a life expectancy of 60 years. When asked about reports which stated that such breast implants would last 8 to 10 years, Dr. Williams said he disagreed, that the data did not support this conclusion, and that although he had not done any tests, his opinion was based on the reports and data he had read and his interpretation of them.

Since silicone gel breast implants were classified as medical devices and not as drugs, they were not listed in the Physicians Desk Reference. [FN233] Therefore, warnings of the product's dangers could be made through advertising, through discussion at medical meetings and seminars, through the contacts with physicians of the sales force of the manufacturer, and through the package inserts. MEC chose advertising and package inserts as the way to communicate the problems and benefits of its breast implants. By May of 1985, MEC knew that silicone had been found in lymph nodes after an implant had occurred, that it might be impossible to remove all the silicone gel from the body if an implant was explanted, that the long-term effect of gel bleed was unknown, and that from anecdotal evidence there was a possible association between the implant and silicone connective tissue disorders and adjuvant disease. [FN234] Yet none of these problems or complications was disclosed in the package insert sent with Plaintiff's breast implants to Dr. Penn. MEC's package insert for Plaintiff's implants did not contain any warning about gel leakage or gel bleed and the possible harms to the patient from gel migration, the possible effect on the patient's lymphatic system, or the possible adjuvant effect. [FN235] The package insert also did not fairly describe the probability of capsular contracture, which occurs in the great majority of patients, the possibility of distortion of the breast from capsular contracture, or the probability that upon removal of the implant, natural breast tissue would be lost, unsightly scars would remain, and particles from the gel bleed which had migrated past the capsule could remain.

FN233. The "PDR" lists drugs, vaccines, and other biologicals, describes the medical product, explains its use, and gives warning of its toxicity and dangers. It is updated every three to six months and reproduced as a whole annually.

FN234. Deposition of Lock at 1433-43, 1448-49, 1594, & 1596.

FN235. The package insert for Plaintiff's implants was identified as Plaintiff's Exhibit 1.77. However, Dr. Busch pointed out that MEC used more than one version of a package insert at a time. In addition, the inserts were not necessarily put into the implant box as of the date of manufacture, so an older implant could have a new insert or an old package insert could be placed in a new implant box. In 1988, MEC included in its package insert a reference to gel bleed under the "Complications" section, not under the "Warnings" section. Although this reference to gel bleed occurred in the package inserts in 1988, it was known to MEC since the 1970s and no "Dear Doctor" letter, a standard method for rapid communication of a harm to a patient from use of a product, was ever sent. Further, Dr. Zeigler noted that the package insert contained no warning that a closed capsulotomy may increase gel bleed.

As Dr. Busch testified, if no clinical trials are done, no warnings of the danger from a product is contained in the package insert, and no patient registry has been kept, the manufacturer should communicate with patient users and doctor users by setting up a list of immunologists and internists in a geographic area in order to communicate with the manufacturer concerning the types of problems seen in patients. No effort to do so was made by MEC.

*26 MEC failed to quantify the problems with its product. It failed to communicate the dangers associated with its product of which it had knowledge. It did not act in accordance with generally accepted pharmaceutical and medical device manufacturing practices.

Several years after she received her breast implants, Plaintiff learned that the devices were a slow delivery system of silicone gel inside her body, that no study of the effects of such phenomenon had been conducted, and that she was suffering from extremely severe and chronic symptoms which were increasing and which were manifested as a collection or cluster of ongoing and worsening problems after the implant operation. She also had developed an unsightly bulge in one of her breasts for which the painful closed capsulotomies performed by Dr. Penn provided no remedy. She had the devices explanted. In the course of this operation, the implants, the capsules which had formed around the implants, and her own breast tissue were removed by necessity, leaving her with less breast tissue than she had when the implant operation occurred and with unsightly permanent scars. [FN236] She was also left with particles of silicone gel in her body.

FN236. Dr. Caldwell testified that he "had to look hard" to see Plaintiff's breasts on his examination. While he noted that her scars from the explant had healed well, he testified that she had little breast tissue remaining. Dr. Worthing testified that nothing more could be done about the scars remaining on Plaintiff's breasts after the explant operation.

Dr. Williams testified that while removal of the implant would be a minor consideration in its design, the ability to achieve safe removal of the complete device should have been included in the design. He further testified that while the vast majority of gel bleed remains on the surface of the implant, a small amount may gain access to the surrounding tissue. If that tissue is not taken out on explant, gel bleed will stay in the tissue. [FN237] Plaintiff's explanting physician testified that he tried to retrieve silicone gel which had migrated past the capsule when he removed the capsule and the implants. This would necessarily include removal of Plaintiff's breast tissue.

FN237. Dr. Williams did not recall if MEC warned on the package insert that on removal the patient may lose breast tissue. It did not.

The preponderance of the evidence establishes that particles of the silicone gel remained in Plaintiff's body after explant causing continuation of the foreign body reaction and inflammation of her tissues. While Plaintiff's plastic surgeon and certain experts presented by Defendant testified that removal of the implants was not medically necessary, [FN238] the Court finds that Plaintiff has proven by a preponderance of the evidence that removal of the implants was reasonable under the facts of this case.

FN238. On Plaintiff's last visit to him on January 25, 1993, Dr. Penn testified that he discussed with her performing an open capsulotomy and removing a portion or all of the capsule or removing and replacing the implant. In Dr. Penn's opinion it was not medically necessary for Plaintiff to have her implants removed when he last saw her in 1993. Dr. Shons concurred that removal of Plaintiff's implants was not medically necessary, although he testified that because of the deformity in the upper quadrant of Plaintiff's breast, it was reasonable to remove the implant. Dr. Shons testified that Plaintiff's implants had lasted a long time and could be expected to last longer.

In this product liability action, Plaintiff Melinda Barrow alleges that she suffered autoimmune and neurological disease (systemic silicone disease), as well as local injuries, as a result of the bleeding of low molecular weight liquid silicone through the silicone envelope of her breast implants. The parties' Joint Pretrial Statement lists the following theories upon which Plaintiff seeks recovery: strict liability, negligence, fraud, failure to warn, breach of warranties, negligence per se, misrepresentation, common plan to prevent public awareness of breast implant hazards, corporate joint venture liability, control and/or supervision of joint ventures, invalidity of indemnification agreements, alter ego liability, and punitive damages. (Doc. No. 131 at 2). Plaintiff's Trial Memorandum, filed four days after the parties' Joint Pretrial Statement, addresses Plaintiff's theories of strict liability, negligence, breach of warranties, fraud, and theories relating to Bristol-Myers Squibb Company's corporate relationship with MEC, [FN239] in addition to theories not raised in the Joint Pretrial Statement, liability based upon certain consumer protection statutes, the Florida Drug and Cosmetic Act, Fla. Stat. §§ 499.001-499.081, and the Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. §§ 501.201-501.213. [FN240] (Doc. No. 135 at 11). As defenses to Plaintiff's theories, Defendant MEC has raised the learned intermediary doctrine and Plaintiff's assumption of the risk. In addition, MEC contends that Plaintiff cannot recover on her breach of warranty claims because there is no privity between Plaintiff and MEC and cannot recover under the consumer protection statutes because no private right of action exists under such statutes. Finally, MEC asserts that Plaintiff has produced no evidence that would support an award of punitive damages.

FN239. Plaintiff's claims relating to Bristol-Myers Squibb Company will not be addressed since the Court approved the parties' Joint Stipulation of Discontinuance of the action as to this Defendant. (Doc. No. 268).

FN240. Pursuant to Local Rule 3.06(e), "[a]ll pleadings filed by any party prior to filing of the pretrial statement shall be deemed merged therein. The pretrial statement and the pretrial order, if any, will control the course of the trial and may not be amended except by order of the Court in the furtherance of justice." Thus, Plaintiff has improperly attempted to raise claims based upon state consumer protection statutes in her Trial Memorandum. Notwithstanding the foregoing, as discussed infra in this opinion, such claims are not meritorious.

*27 Since jurisdiction in this action is founded upon diversity of citizenship, 28 U.S.C. § 1332, this Court is bound to apply state substantive law to Plaintiff's claims. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).

Strict liability is defined as negligence as a matter of law or negligence per se; it relieves the plaintiff of the burden of proving specific acts of negligence. See West v. Caterpillar Tractor Co., Inc., 336 So.2d 80, 90 (Fla.1976). Florida has adopted the doctrine of strict liability as stated in the Restatement (Second) of Torts, section 402A. See id. at 87. In the case adopting the doctrine of strict liability, the Florida Supreme Court stated, strict liability should be imposed only when a product the manufacturer places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being. The user should be protected from unreasonably dangerous products or from a product fraught with unexpected dangers. In order to hold a manufacturer liable on the theory of strict liability in tort, the user must establish the manufacturer's relationship to the product in question, the defect and unreasonably dangerous condition of the product, and the existence of the proximate causal connection between such condition and the user's injuries or damages. Id. at 86-87; see also Norton v. Snapper Power Equip., 806 F.2d 1545, 1548 (11th Cir.1987). While strict liability relieves Plaintiff of proving negligence in the manufacture of her breast implants, whether Plaintiff's case is founded in strict liability, negligence, or breach of an express or implied warranty, Plaintiff still has the burden of establishing (1) that a defect was present in the product; [FN241] (2) that it existed at the time the manufacturer parted possession with the product; and (3) that it caused the injuries of which Plaintiff complains. See Cassisi v. Maytag Co., 396 So.2d 1140, 1143 (Fla.Dist.Ct.App.1981); Pulte Home Corp., Inc., v. Ply Gem Industries, Inc., 804 F.Supp. 1471, 1486 (M.D.Fla.1992); Humphreys v. General Motors Corp., 839 F.Supp. 822, 825-29 (N.D.Fla.1993), aff'd, 47 F.3d 430 (11th Cir.1995). "A product may be in a defective condition due to a design defect, a manufacturing defect or defective warnings." Brown v. Glade & Grove Supply, Inc., 647 So.2d 1033, 1035 (Fla.Dist.Ct.App.1994); see generally Ford Motor Co. v. Hill, 404 So.2d 1049 (Fla.1981) (theory of strict liability may be applied to both defects in product design and manufacture).