Melinda Barrows/14

*35 Finally, the package insert did not adequately warn of the numbness of the breast that could result upon explant. [FN268] MEC breached its duty adequately to warn of the foregoing risks; this rendered MEC's silicone gel breast implant product defective under a negligence theory. [FN269]

FN268. The package insert states: "Hypertrophic scarring and loss of/or diminished nipple sensation have been reported." Plaintiff's Exhibit 1.77 at 7.

FN269. 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. MEC failed to do this.The learned intermediary doctrine does not absolve Defendant MEC of liability for failure to warn of gel bleed, although Dr. Penn, Plaintiff's implanting doctor, should have informed Plaintiff of gel bleed when he learned of it and, at that time, should have warned her of the foreign body reaction that could result from such gel bleed. When Plaintiff received her implants in 1985, Defendant did not show that Dr. Penn had "substantially the same" knowledge as an adequate warning about gel bleed from the manufacturer should have communicated to him. Defendant did not prove that in 1985 Dr. Penn had independent knowledge of the fact that Plaintiff's breast implants would continuously leak silicone gel into Plaintiff's body after implantation. Dr. Penn testified that at the time of Plaintiff's implantation he probably did not discuss gel bleed with Plaintiff because there was not much knowledge about gel bleed at that time. In addition, the consent form signed by Plaintiff at the time of surgery did not warn of gel bleed. [FN270] However, Dr. Penn also testified that while he did not know when or how he first learned of gel bleed, he had learned of gel bleed sometime in the latter half of the 1980s and began using lower gel bleed implants in 1987. Despite learning of gel bleed during this period, Dr. Penn did not inform Plaintiff of gel bleed during her several visits to him subsequent to the implantation surgery and until 1993. Furthermore, Dr. Penn was aware that a foreign body reaction would occur in response to silicone gel extruding into the breast tissue area, although he did not know of the extent of such reaction. He testified that in 1985, when he performed the implant procedure on Plaintiff, he thought that if a silicone gel breast implant ruptured, the gel would extrude and the scar tissue capsule around the implant would contain the gel. He testified further that he thought that the gel would be "taken-up" by the surrounding breast tissue which would form a foreign body reaction but that there should be very little foreign body reaction to the gel because silicone is one of the most easily tolerated foreign materials in the body. Thus, it is clear that at some point in the latter half of the 1980s, Dr. Penn did have independent knowledge of gel bleed and that such gel could cause a foreign body reaction, although he thought that such reaction would be minor. Nevertheless, Dr. Penn failed to warn Plaintiff of gel bleed and the resulting foreign body reaction. Accordingly, the learned intermediary doctrine does not absolve MEC of liability for failing to warn of gel bleed prior to Plaintiff's implantation and for continuing to fail to provide such warning until Dr. Penn learned of gel bleed.

FN270. See supra note 11.

*36 Furthermore, the learned intermediary doctrine does not absolve MEC of liability for failing to warn of other risks in addition to gel bleed. Neither the consent form nor Dr. Penn warned Plaintiff that upon explantation, silicone gel may remain in the body. No evidence was presented that Dr. Penn independently knew that all of the silicone that had escaped through gel bleed could not be removed upon explantation. While the consent form and Dr. Penn warned Plaintiff of capsule contracture, neither made clear the extent and probability of such capsule contracture. [FN271] No evidence was presented that Dr. Penn independently knew of the extent and probability of capsule contracture. Neither Dr. Penn nor the consent form warned Plaintiff of the loss of breast tissue in the event of explantation. No evidence was presented that Dr. Penn independently knew that breast tissue would have to be removed along with the implants upon explantation. While the consent form did warn that "[i]n some patients the margin of the implants can be felt," it did not warn of the possibility that the shape of the breast may be deformed due to capsule contracture. Furthermore, while Dr. Penn did testify that he discussed with Plaintiff the possibility of contracture associated with the capsule formation around the implant causing distortion, there is no evidence that he made clear to plaintiff, or that he had independent knowledge of the possibility of the extent of such deformity. In fact, Dr. Penn testified that he did not understand that the implants could become as distorted as one of Plaintiff's did. Finally, the consent form did not warn of the possibility of the migration of silicone gel from gel bleed to other parts of the body. [FN272]

FN271. The consent form provided: "The breasts can become firm (capsule formation and contraction). This condition can be permanent and can cause pain and discomfort." Plaintiff's Exhibit 1.96(a).

FN272. The consent form stated: The implant shell theoretically could be broken at some point in the life of the implant or during the duration it is implanted. The gel contained within is medical grade and the same as the shell design and would in all probability be confined to the space behind the breast where the implant was implanted. This should not cause any serious side effect. Plaintiff's Exhibit 1.96(a).

Dr. Penn testified that in 1985 when he performed the implant procedure on Plaintiff he thought that if the breast implants were ruptured and the gel extruded, the scar tissue capsule would contain the gel; he did not know that the silicone gel could bleed into the capsule and migrate to the lymph nodes.

Dr. Penn did not have independent knowledge of the scarring and numbness that could occur upon explant. The consent form only states that "the incision will heal with a scar which will be permanent." [FN273] While Dr. Penn testified that he discussed with Plaintiff the possibility of problems with wide scars, this discussion related only to implantation. Further, while the consent form also warned that "[n]umbness or hypersensitivity of the nipple may be experienced following surgery" [FN274] and Dr. Penn testified that he discussed with Plaintiff the problem of numbness or hypersensitivity in the breasts, the consent form and Dr. Penn's discussion did not relate to explantation.

FN273. Plaintiff's Exhibit 1.96(a).

FN274. Id.

Therefore, the learned intermediary doctrine provides no defense to Defendant's failure to warn of the foregoing.

In addition to establishing that the product was defective, a product liability plaintiff suing under any theory has the burden of proving by a preponderance of the evidence, with "reasonable medical probability," that her injuries were proximately caused by the defective product. See, e.g., Christopher, 53 F.3d at 1191; see also Cassisi, 396 So.2d at 1143; Pulte Home Corp., 804 F.Supp. at 1486; Humphreys, 839 F.Supp. at 825-29. The concept of proximate causation encompasses a causation-in-fact analysis. The general test for causation-in-fact is whether "but for" Defendant's act, the injury would not have occurred. See, e.g., Stahl, 438 So.2d at 17-18. However, in those cases in which each of two or more concurring causes could alone have produced the plaintiff's injury, the court will apply the "substantial factor" test for causation-in-fact. Id. at 18-19. In such case, a defendant's conduct is considered a cause of the plaintiff's injury if such conduct was a material and substantial factor in bringing about the injury. Id. (citation omitted).

*37 If causation-in-fact is shown, then the court considers the issue of proximate causation. The test for proximate causation is one of foreseeability and "is virtually impossible to capture in a single formula and plainly has no canonical form." Id. at 19. The Stahl Court explained: Florida courts, in accord with courts throughout the country, have for good reason been most reluctant to attach tort liability for results which, although caused-in-fact by the defendant's negligent act or omission, seem to the judicial mind highly unusual, extraordinary, bizarre, or, stated differently, seem beyond the scope of any fair assessment of the danger created by the defendant's negligence. Plainly, the courts here have found no proximate cause in such cases based solely on fairness and policy considerations, rather than actual causation grounds. Id.

With regard to her "systemic" injuries, [FN275] Plaintiff has failed to prove both general and specific causation. Plaintiff has failed to prove by a preponderance of the evidence that silicone gel breast implants are capable of causing connective tissue disorders and their manifestations. In addition, Plaintiff has failed to prove by a preponderance of the evidence that her silicone gel breast implants caused her alleged connective tissue disorder and its manifestations. She has failed to prove by a preponderance of the evidence that, but for the bleeding of low molecular weight silicone gel through the silicone envelope of her breast implants, she would not have suffered her alleged connective tissue disorder that manifests itself as irritable bowel syndrome, chronic fatigue, joint pain, rashes, myalgia, and weight loss. [FN276] Furthermore, Plaintiff cannot show that her alleged connective tissue disorder and its manifestations were proximately caused by the bleeding of silicone gel from her breast implants.

FN275. Plaintiff defined her systemic injuries as a connective tissue disorder that manifests itself in irritable bowel syndrome, chronic fatigue, joint pain, rashes, myalgia, and weight loss. Plaintiff's Trial Memorandum, Doc. No. 135 at 2. She defined her local injuries as pain, numbness, and breast deformity from capsular contracture, surgery to remove the implants with the attendant removal of large amounts of her breast tissue, scarring, and pain, pulling, and limitation of movement, in addition to further numbness of her breast, upon explantation. Id. Both sides have classified Plaintiff's alleged injuries as either "local" or "systemic." Although this is an artificial dichotomy that is not necessarily accurate or helpful since there is no bright line between what constitutes a local injury versus what constitutes a systemic injury, because the parties have used this dichotomy in presenting the case to the Court, the Court will utilize these terms in its discussion of these issues.

FN276. In addition, Plaintiff has not shown that gel bleed was a material and substantial factor in bringing about her alleged connective tissue disorder and its manifestations.

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]