Melinda Barrow/15

Plaintiff's effort to prove causation with regard to her alleged systemic injuries was a Herculean effort. [FN277] Although experts are willing to opine on the issue of whether connective tissue disorder and its permutations and manifestations are caused by silicone gel and although various articles and studies attempt to link or not link such disorder and its permutations and manifestations to silicone gel, the amalgam of such opinions, articles, and studies fails to prove by a preponderance of the evidence, within "reasonable medical probability," that silicone gel causes connective tissue disorder and its complications. Unfortunately for this Plaintiff at this time and on this record, the issue of whether silicone gel can cause connective tissue and autoimmune disorders is far from clear in the scientific medical community. [FN278] It is not the function of this Court to speculate or to prophecy the ultimate conclusion on systemic silicone disease causation with regard to silicone gel. [FN279]

FN277. Defendant challenged three of Plaintiff's experts, Dr. Gary Solomon,Dr. Frank Vasey, and Dr. Laurie L. Barclay, under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592-93, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) (requiring trial courts to screen evidence provided by experts to ensure its reliability by conducting a "preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue"); see also General Elec. Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). The Court finds Defendant's motion for a Daubert inquiry as to Dr. Vasey and Dr. Barclay to be moot since neither doctor testified at trial. In addition, the Court finds that Defendant's Daubert challenge as to Dr. Solomon is moot because, regardless of Dr. Solomon's testimony, Plaintiff has failed to meet her burden to show causation with regard to her alleged connective tissue disorder and its manifestations.

FN278. Resolution of causation issues is often a slow process in toxic torts cases such as this one. As an example, consider the issue of causation with regard to asbestos: Even after the recognition of asbestos as the cause of disease, and billions spent on litigation, numerous basic disputes about causation persist: Do all asbestos fibers, or only some, cause harmful effects? What is the correct dose-response relation? Which cancers other than mesothelioma and lung cancer are attributable to asbestos? Margaret A. Berger, "Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts," 97 Colum. L.Rev. 2117, 2118 n.7 (1997).

FN279. Perhaps the "systemic" causation issues in the silicone breast implant arena will be determined more quickly than similar causation issues in other arenas through the Panel on Multidistrict Litigation's appointment of a group of experts to consider such issues. To date this panel has not returned its report on issues of causation related to silicone gel.

In failing to find that Plaintiff's alleged connective tissue disorder and its manifestations were caused by the bleeding of silicone gel from her silicone gel breast implants into her body, the Court recognizes the unfairness inherent in the current state of the law which places the burden of proof with regard to causation of such injury on the Plaintiff in a case such as this. MEC did not rely on epidemiology when it represented that its silicone gel breast implants were safe, nor did it even propose use of epidemiology to study the issues of contracture, gel bleed, rupture, or rheumatical complaints in women who had received silicone gel breast implants. Furthermore, despite MEC's knowledge that its implants leaked silicone gel after implantation and that there was linkage between such gel bleed and auto-immune (or systemic) disease within a part of the medical community, none of the limited tests done by MEC were designed to determine the effect of gel bleed on the human body. No such tests were done despite MEC's knowledge that direct injection of the same material produced as a "lite" in the silicone gel in MEC's breast implants, in greater amounts, had caused injury and death to humans. Nevertheless, MEC conducted no tests to determine if there was an association between gel bleed and autoimmune disease. The limited amount of testing conducted by MEC included short-term animal tests, including the beagle tests. However, the beagle tests were abandoned when potentially adverse results were found. Not only were the standard clinical trials not done on the silicone gel breast implants, other than short-term animal studies and the abandoned, yet alarming beagle study, but also MEC undertook no effort to gather clinical data or to study users of its breast implants over a period of years on a regular basis by keeping a patient registry. [FN280]

FN280. Ms. Lock testified that testing for the effects of gel bleed could have been done in 1970 by MEC, and it was done but only for a short time on the beagle dogs.

*38 Several years after she received her breast implants, Plaintiff learned that a slow delivery system of silicone gel had been placed inside her body, that no study of the effects of such phenomenon had been conducted, and that she was suffering chronic symptoms which were worsening.

The foregoing demonstrates that MEC, the party in the superior position to know of the defects in its product and the party with the superior economic capability to design and conduct tests to determine the safety of its product before offering it for sale, essentially turned a blind eye to the harms that could befall a person implanted with its silicone gel breast implants. MEC took an "ostrich approach" to potential harms from its product so that it could contend, as it has done in this case, that it "did not know" of such harms when complaints were made. Such deliberate ignorance should not be condoned.

By placing the burden of proof with regard to causation on the Plaintiff, a person less likely to have the financial means or scientific knowledge to conduct epidemiological studies than the manufacturer that puts such product on the market, the law gives incentive to corporate America not to conduct proper tests to determine product safety. The fewer tests done by MEC, the less likely it would be that adverse effects of silicone gel bleed could be proven by a plaintiff who believed she had been injured by MEC breast implants, and the less likely that causation, responsibility and accountability could later be placed on MEC's doorstep. From a policy standpoint, placing the burden of proof on the plaintiff in a scientifically-based torts case of this magnitude is detrimental to society. The law thus encourages corporations to act irresponsibly in failing to develop and disclose information relating to potential harms caused by defects in their products.

In her essay on toxic torts in honor of Judge Jack B. Weinstein, Professor Berger advocates abolishing proof of general causation as the decisive factor in toxic tort litigation. Margaret A. Berger, "Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts," 97 Colum. L.Rev. 2117 (1997). Professor Berger writes "conditioning liability on plaintiff's ability to prove that defendant's product caused plaintiff's illness is counterproductive; the insistence on causation creates incentives on the part of corporations not to know and not to disclose." Id. at 2119. Under Professor Berger's proposed model, liability in negligence would be imposed for failure to provide substantial information relating to risk and proof that the failure caused plaintiff's injury would not be required; defendants would be relieved of liability for injuries caused by exposure to their products, provided that they had met the required standard of care for developing and disseminating information relevant to risk. Id. at 2143.

Notwithstanding Professor Berger's proposed model and despite this Court's view of the unfairness of placing the burden of proof as to causation on the plaintiff in a case such as this, the Court is bound to apply the law as it is presently constituted and to find that Plaintiff has failed to prove causation with regard to her alleged connective tissue disorder, systemic silicone disease, and its manifestations.

*39 Despite Plaintiff's failure to prove causation with regard to her systemic injuries, the Court finds that Plaintiff has proven by a preponderance of the evidence that she has suffered a chronic foreign body reaction caused- in-fact by the design defect in Defendant's product, about which Defendant failed to warn, the leakage of silicone gel from Plaintiff's breast implants. Such foreign body reaction resulted in chronic inflammation of the tissue in the breast area. [FN281] But for Defendant's product design, Plaintiff would not have suffered a chronic foreign body reaction to gel bleed in her breast tissues and in her lymph nodes. In addition, but for Defendant's failure to warn of gel bleed and gel migration, Plaintiff probably would not have suffered the chronic foreign body reaction and gel in her lymph nodes because she would have chosen not to become implanted. In her testimony, Plaintiff indicated that she would not have had implantation of silicone gel breast implants had she learned of gel bleed and learned that it would be "harmful." [FN282] This statement along with the remainder of Plaintiff's testimony and the record show that Plaintiff probably would not have had the implantation had she known that the implants were designed to leak silicone gel and had she known that silicone had been found in lymph nodes after an implant had occurred. Plaintiff would probably not have had the implantation if she had known that it might be impossible to remove all the silicone gel from her body if the implant were explanted, that from anecdotal evidence there was a possible association between the implant and silicone connective tissue disorders and adjuvant disease, that any foreign material inserted into her body would cause a foreign body reaction, that the extent of the foreign body reaction caused by silicone gel continuously being emitted into her body was not known, that MEC had failed to conduct adequate tests to determine the long-term effects of the leaking silicone on the body, and that the same material produced as a "lite" in the silicone gel in MEC's breast implants was known to have caused injury and death when injected directly in women's breasts.

FN281. See supra part II.C.2.

FN282. Plaintiff testified as follows:

Q. If you had learned before you made the decision to have implants about the concept of bleeding or leaking, what would you have done?

MR. CABANISS: I object, your honor, calling for speculation.

THE COURT: Well, I will go ahead and let her answer.

THE WITNESS: I would have asked if something leaked out would it be harmful.

BY MS. DUNLEAVY:

Q. If you had learned there was a possibility silicone could cause an immune disease, what would your decision have been?

A. There's no way--

MR. CABANISS: Again, I object, your honor, speculation.

THE COURT: Overruled.

THE WITNESS:

Even if I knew it happened to one person, there's no way.

Transcript, Doc. No. 256 at 2679-80.

Furthermore, Plaintiff has proven by a preponderance of the evidence that she suffered other injuries caused-in-fact by Defendant's failure to warn about the probability and extent of capsular contracture, the possibility and extent of distortion of the breast from capsular contracture, and the probability that upon removal of the implant, natural breast tissue would be lost, the extent of scarring upon explant, and the numbness in her breasts after explant. Plaintiff underwent numerous painful "closed capsulotomies" or "squeezes" due to the hardening of her breasts from capsule contracture which provided only temporary relief to Plaintiff from significant hardening of the breasts and probably resulted in an increase of gel bleed into her body from the implants. The shape of one of Plaintiff's breasts was deformed while she had implants due to a significant bulging of the implant against the skin. In addition, silicone gel migrated away from Plaintiff's implants, and the greater weight of the evidence showed that such gel migrated at least as far as Plaintiff's lymph nodes. Dr. Worthing testified that during the course of explantation, he removed some of Plaintiff's interior breast tissue, and since Plaintiff is very thin, the cosmetic deformity resulting is more pronounced. Plaintiff suffered significant, permanent scarring upon explantation and, after explantation, continues to suffer numbness in her breasts. The Court finds that but for Defendant's failure adequately to warn of the probability and extent of capsular contracture, the possibility and extent of distortion of the breast from capsular contracture, the probability that upon removal of the implant, natural breast tissue would be lost, the extent of scarring upon explantation, and the numbness in the breasts that could occur upon explantation, Plaintiff would not have suffered the foregoing injuries. It is more likely than not that Plaintiff would have chosen not to be implanted had she known of the foregoing complications.

*40 With regard to proximate causation, Plaintiff's injuries were foreseeable. The testimony showed that MEC designed the implants so that the silicone gel within the elastomer shell would continuously leak into the body after implantation even though it 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 were explanted, that any foreign material inserted into the body causes a foreign body reaction, that the extent of the foreign body reaction caused by silicone gel continuously being emitted into the body was not known, MEC had failed to conduct adequate tests to determine the long-term effects of the leaking silicone on the body, and that direct injection of the same material produced as a "lite" in the silicone gel in MEC's breast implants, albeit in greater amounts, had caused injury and death. In addition, MEC knew of, and it was knowable in light of the generally recognized and prevailing scientific and medical knowledge available, or a reasonably prudent manufacturer would have known of, the probability and extent of capsular contracture, the possibility and extent of distortion of the breast from capsular contracture, and the probability that upon removal of the implant, natural breast tissue would be lost, the extent of scarring upon explantation, and the numbness in the breasts that could occur upon explantation. Furthermore, Defendant has presented the Court with no meritorious contention of fairness or policy considerations that militate in favor of finding lack of proximate causation. Accordingly, the Court finds that Defendant's defective product and its failure to warn of the defect and other risks associated with its implant proximately caused Plaintiff injury.

Plaintiff has proven by a preponderance of the evidence that MEC's silicone gel breast implants were defective because of their design and because of MEC's failure to warn of such design in addition to MEC's failure to warn of other risks associated with the implants. She has proven that such defects existed at the time the defendant manufacturer parted possession with the implants, and she has proven that such defects caused her injury. Accordingly, Plaintiff is entitled to recover appropriate damages for certain of her injuries.

In addition to the learned intermediary doctrine discussed above, Defendant has raised the defenses of assumption of the risk and "state of the art."

1. Assumption of the Risk

In Hoffman v. Jones, 280 So.2d 431 (Fla.1973), the Florida Supreme Court adopted the rule of comparative negligence. In Blackburn v. Dorta, 348 So.2d 287 (Fla.1977), the Florida Supreme Court considered the effect of the Hoffman decision on the common law doctrine of implied assumption of the risk; the court did not consider the doctrine of express assumption of the risk. See id. at 290 ("Included within the definition of express assumption of risk are express contracts not to sue for injury or loss which may thereafter be occasioned by the covenantee's negligence as well as situations in which actual consent exists such as where one voluntarily participates in a contact sport."). In Blackburn, the Florida Supreme Court held that "the affirmative defense of implied assumption of risk is merged into the defense of contributory negligence and the principles of comparative negligence enunciated in Hoffman v. Jones ... shall apply in all cases where such defense is asserted." Id. at 293.

*41 To the extent that Defendant MEC is asserting that Plaintiff expressly assumed the risk of gel bleed, such contention cannot be maintained in light of the failure of MEC, and later Plaintiff's physician, to inform Plaintiff of gel bleed. Since Plaintiff did not know or have reason to know that silicone gel would bleed from her breast implants after implantation, it cannot be said that she expressly assumed any risk associated with such gel bleed. See Donaldson v. Cenac, 675 So.2d 228, 230 (Fla.Dist.Ct.App.1996).

To the extent that Defendant is asserting implied assumption of the risk, such defense is no longer a complete bar to recovery. It has been merged into the defense of contributory negligence, and the principles of comparative negligence apply. Comparative negligence may be raised as a defense to an action in strict liability if "based upon grounds other than failure of the user to discover the defect in the product or failure of the user to guard against the possibility of its existence." Kidron, Inc., v. Carmona, 665 So.2d 289, 291 (Fla.Dist.Ct.App.1995). Defendant has failed to show that Plaintiff assumed any risk with regard to gel bleed and that, therefore, her recovery should be reduced by her equitable share of fault.

In addition, the Court finds that Plaintiff did not expressly or impliedly assume the risk of suffering capsule contracture to the extent she did, the possibility that her breasts could become as deformed as one did after implantation, the chronic foreign body reaction caused by the silicone gel particles emitted into her body, or the loss of breast tissue and the scarring from the explant operation, or the numbness in her breasts after explantation. Accordingly, Defendant has wholly failed to show that a reduction based upon Plaintiff's assumption of the risk in the amount of damages is appropriate.

Defendant has raised the state of the art defense. "State of the art" relates to the "existing level of technological expertise and scientific knowledge relevant to a particular industry at the time a product is designed." See, e.g., Crispin v. Volkswagenwerk AG, 248 N.J.Super. 540, 591 A.2d 966, 973 (N.J.Sup.App.Div.), cert. denied, 126 N.J. 385, 599 A.2d 162 (N.J.1991). A state of the art analysis is relevant to the adequacy of the design of a product under the risk-benefit/utility test. Id. The custom of an industry can be relevant to this defense, but such custom is to be considered with other evidence and is not dispositive. Id. Compliance with the state of the art does not necessarily require finding in the defendant's favor. Id.

While conceding that the state of the art defense is applicable to negligence claims, Plaintiff has contended that such defense is not applicable to actions sounding in strict liability. Noting the absence of Florida law directly on point, the Eleventh Circuit Court of Appeals has stated that "it is reasonable to conclude that the Florida courts would follow the view that 'state of the art' evidence is relevant both to the plaintiff's case and to the defense ." Norton v. Snapper Power Equip., 806 F.2d 1545, 1549 (11th Cir.1987), reh'g denied, 812 F.2d 1415 (11th Cir.1987). [FN283] The Eleventh Circuit noted further that the Florida Supreme Court has stated that one of the factors to consider when determining whether a product is unreasonably dangerous is " 'the ability to eliminate or minimize the danger without seriously impairing the product or making it unduly expensive." ' Id. at 1549 (quoting Radiation Technology, 445 So.2d at 331). However, the Eleventh Circuit stated that although it found a state of the art defense in design defect cases, it considered the feasibility of alternative designs to be only one factor in the analysis. Id.

FN283. While finding that there is a "state of the art" defense in strict liability design defect cases under Florida law, the Eleventh Circuit noted the controversy over this point and stated: It is perhaps a misnomer to refer to "state of the art" as a defense. Plaintiffs might want to offer evidence as to the feasibility of installing a particular safety device to show why a product was defective. This would give the jury a model by which to judge the dangerousness of the defendant's product. On the other hand, defendants would want to show that their product could not have been made safer given the technology in existence at the time of manufacture. In either case, the use of "state of the art" evidence infuses some measure of "fault" analysis into the strict liability equation. Norton, 806 F.2d at 1549 & n. 3.

*42 Defendant has wholly failed to prove that it is entitled to shield itself from liability through application of the state of the art defense. Although testing standards in place at the time Plaintiff's implants were designed and sold may have required limited testing, this evidence is only one factor to be considered and is not dispositive. The following is more persuasive to the Court on this issue. Despite knowledge that its breast implants were designed to bleed silicone gel, that risks, both known and unknown, attended this gel bleed, that it had done no tests to determine the effect of this leaking gel on the body, [FN284] although it could and should have, and that adverse findings had resulted in its own beagle study, Defendant MEC chose both not to use an alternative design for its implants that did not leak silicone gel and not to warn of such leakage in the product it did sell for implant. As noted above in this Court's discussion of the risk versus benefit/utility test, 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. Initially, Lynch had selected the Perras-Papillon breast implant for sale by MEC; it did not bleed because it did not have a pure silicone envelope. However, silicone gel implants were preferred by MEC. Dr. Blais testified that a gel could have been made that would not change. According to Dr. 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. No evidence was presented that the alternative designs or the SCL were more expensive to produce. Thus, Defendant has not shown that it should be able to avail itself of the state of the art defense.