Melinda Barrow/13

*32 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. [FN259] 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 anticipate that the implants could become as distorted as one of Plaintiff's did. [FN260]

FN259. 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).

FN260. One of Plaintiff's breasts became significantly distorted in shape after implantation. See Plaintiff's Exhibits 1.75(a), (d), (k), & (1).

Further, the consent form did not warn of the possibility of the migration of silicone gel from gel bleed to other parts of the body. [FN261] 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.

FN261. 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).

Finally, Dr. Penn did not have independent knowledge of the scarring and numbness that could occur upon explant. The consent form only states that "[t]he incision will heal with a scar which will be permanent." [FN262] While Dr. Penn testified that he discussed with Plaintiff the possibility of problems with wide scars, this discussion related only to implantation. Furthermore, while the consent form also warned that "[n]umbness or hypersensitivity of the nipple may be experienced following surgery," [FN263] 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.

FN262. Plaintiff's Exhibit 1.96(a).

FN263. Id.

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

Plaintiff has also asserted a product liability claim based upon the theory of negligence. To recover under such theory, Plaintiff has the burden of establishing the following: *33 (1) a legal duty on the part of the defendant towards the plaintiff under the circumstances; (2) a breach of that duty by the defendant; (3) the defendant's breach of duty was both the actual and proximate cause of the plaintiff's injuries; and (4) the plaintiff suffered damages as a result of the breach. Humphreys, 839 F.Supp. at 829 (citing Paterson v. Deeb, 472 So.2d 1210, 1214 (Fla.Dist.Ct.App.1985); Simon v. Tampa Elec. Co., 202 So.2d 209 (Fla.Dist.Ct.App.1967)); see also Stahl v. Metropolitan Dade County, 438 So.2d 14, 17 (Fla.Dist.Ct.App.1983).

"[T]he manufacturer must use reasonable care in design and manufacture of its product to eliminate unreasonable risk of foreseeable injury." Ford Motor Co. v. Evancho, 327 So.2d 201, 204 (Fla.1976); see also Light v. Weldarc Co., 569 So.2d 1302, 1303 (Fla.Dist.Ct.App.1990) (" 'There is no doubt whatever that the manufacturer is under a duty to use reasonable care to design a product that is reasonably safe for its intended use and for other uses which are foreseeably probable." ') (quoting Prosser, The Law of Torts 644-45 (4^th ed.1978)). When evaluating the design of a product, " 'the question turns on what is reasonable care and what is reasonable safety." ' Light, 569 So.2d at 1303 (quoting Prosser, supra, at 644-45).

Defendant MEC clearly had a duty to use reasonable care to design breast implants that were reasonably safe for their intended use. Plaintiff has shown that MEC breached that duty by failing to eliminate unreasonable risk of foreseeable injury. 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 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 the body causes a foreign body reaction and the extent of the foreign body reaction caused by silicone gel continuously being emitted into the 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, [FN264] 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 light of the these unreasonable risks of foreseeable injury, a reasonably prudent manufacturer under the circumstances would have either eliminated gel bleed through use of alternative designs, warned of such gel bleed, or removed its product from the market. MEC did none of these things. Thus, MEC breached its duty of care with regard to its implant design.

FN264. Lynch himself noted the necessity for such tests, and other experts testified that the standard for testing implantable devices at the time Plaintiff received her implants would require such tests.

*34 As stated above, "Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about." Ferayorni, 711 So.2d at 1172 (quoting Anderson, 281 Cal.Rptr. 528, 810 P.2d at 558); see also Johns-Manville Sales Corp. v. Janssens, 463 So.2d 242, 251 (Fla.Dist.Ct.App.1984) ("A duty to warn attaches, not when scientific certainty is established, but whenever a reasonable man would want to be informed of the risk in order to decide whether to expose himself to it."), pet. for rev. denied, 467 So.2d 999 (Fla.1985).

As discussed with reference to Plaintiff's failure to warn claim under a theory of strict liability, by November of 1985, MEC knew that silicone gel bled from its implants after implantation and that this design feature was not easily discoverable, 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 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 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, that it 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 had caused injury and death when injected directly in women's breasts. A

reasonable person would want to be informed of the risks associated with gel bleed in order to decide whether to expose herself to it, and a reasonably prudent manufacturer would have warned of gel bleed in light of the foreseeable risks associated therewith.

As noted above, the package insert accompanying Plaintiff's implants did not warn Dr. Penn of gel bleed. Also, the package insert accompanying Plaintiff's silicone breast implants did not warn of the fact that even if a patient had the implants removed, particles of silicone gel may remain in her body. Finally, the package insert did not warn of the possibility that movement of the body, massage, or closed capsulotomy would increase gel bleed or warn of the possibility of the migration of silicone gel from gel bleed to other parts of the body. Thus, MEC beached its duty to warn of gel bleed, and this rendered Defendant's silicone gel breast implant product defective under a negligence theory.

In addition, also by November of 1985, MEC knew of, 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, the probability that upon removal of the implant, natural breast tissue would be lost, the extent of the scars left by explantation, and the numbness of the breast occurring after explantation. While the "Complications" section of the package insert did warn of capsule contracture, it did not adequately make clear the probability and extent of such capsule contracture, nor did it warn of the possibility of deformity of the breast resulting from capsule contracture. [FN265] Although the package insert did state that the complications of implantation could include "[p]rosthesis displacement" and that inadequate tissue covering could result in "extrusion of the implant," it omitted mention of the extent of such "displacement" or "extrusion" and the possibility that the shape of the breast may be deformed due to the capsular contracture causing the implant to bulge against the skin. [FN266] The package insert did not warn of the loss of breast tissue and resultant permanent scarring in the event of explantation. [FN267]

FN265. The package insert states that a complication of the breast implants is [c]apsule contracture (i.e., heavy fibrous capsule formation), with accompanying firmness and discomfort in the breast, is the most frequently reported complication. This condition may require surgical correction. Closed capsulotomy (i.e., manual compression of the breast) may cause a rupture with potential gel extravasation. Plaintiff's Exhibit 1.77 at 7.

FN266. See Plaintiff's Exhibits 1.75(a), (d), (k), & (1).

FN267. Plaintiff's Exhibit 1.77 at 7.