Melinda Barrow/12

FN241. "There is no dispute that a breast implant is a product for purposes of strict liability. Causes of action in strict liability have been recognized against the manufacturer and other entities responsible for the sale and implantation of various prostheses into the human body, including breast implants." Porter v. Rosenberg, 650 So.2d 79, 81 (Fla.Dist.Ct.App.) (citations omitted), rev. denied, 661 So.2d 825 (Fla.1995).

"Design defects are those which are due to design error because unforeseen hazards accompany normal use of the product created according to design." See Cassisi, 396 So.2d at 1145. The test for determining whether a product is defective varies depending upon the theory asserted. In the law of negligence, a product is defective when the manufacturer has a duty to exercise reasonable care so that its products will be reasonably safe for use in a foreseeable manner, and the manufacturer has breached that duty. See, e.g., Witt v. Norfe, Inc., 725 F.2d 1277, 1278 (11th Cir.1984). When a claim for breach of implied warranty is asserted, a product is defective if it is not reasonably fit for the intended use or reasonably foreseeable use at the time it left the possession of the manufacturer. See Pulte Home Corp., 804 F.Supp. at 1486; In re Standard Jury Instructions, 435 So.2d 782 (Fla.1983). When a claim for breach of an express warranty is asserted, defectiveness of a product is determined by considering whether the product performs in accordance with the express warranty given. See Pulte Home Corp., 804 F.Supp. at 1486-87 (citing 63 Am.Jur.2d Products Liability § 224 (1984 & Supp.1992)). Finally, in the area of strict liability, to establish that a product was defective, a plaintiff must show that, when the product left the manufacturer's control, it was in a defective condition unreasonably dangerous to foreseeable users and bystanders. See West, 336 So.2d at 86-87. In Cassisi v. Maytag Co., the First District Court of Appeal stated that although section 402A of the Restatement (Second) of Torts, adopted by the Florida Supreme Court, appears to require proof that the product was both defective and unreasonably dangerous, the terms "defective" and "unreasonably dangerous" actually seem to be redundant. 396 So.2d at 1143-44. [FN242] Because of the ambiguous standard, some courts have found it unnecessary for a plaintiff to prove both that the product was defective and unreasonably dangerous. Cassisi, 396 So.2d at 1144 (citing Cronin v. J.B.E. Olson Corp., 8 Cal.3d 121, 104 Cal.Rptr. 433, 501 P.2d 1153 (1972); Azzarello v. Black Bros. Co. Inc., 480 Pa. 547, 391 A.2d 1020 (1978); Pyatt v. Engel Equip. Inc., 17 Ill.App.3d 1070, 309 N.E.2d 225 (1974)).

FN242. The Cassisi Court noted: Dean Prosser, the reporter for the Council, explains that the words "unreasonably dangerous" were added to foreclose the possibility that makers of products having the inherent possibility for causing harm, such as drugs, whiskey, sugar, butter, etc., would become "automatically responsible for all the harm that such things do in the world." Thus only "bad" whiskey, butter, etc., are subject to the Restatement's standard. 396 So.2d at 1144 (citing and quoting Prosser, Strict Liability to the Consumer in California, 18 Hastings L.J. 9, 23 (1966)). The Eleventh Circuit Court of Appeals stated, In light of the suggestion in Cassisi that the provision in § 402A that a defective product be dangerously so is merely excess baggage, any distinction drawn between strict liability and negligence on the grounds that § 402A requires that the defect be dangerous, while negligence does not, would be specious. Witt v. Norfe, Inc., 725 F.2d 1277, 1279 (11th Cir.1984).

*28 Notwithstanding the lack of clarity with regard to the proper test for determining whether a product is defective, the Cassisi Court stated, "the standard for all product defects under Section 402A is the same: Were the ordinary consumer's expectations frustrated by the product's failure to perform under the circumstances in which it failed?" Cassisi, 396 So.2d at 1144-45. However, the court noted that while this standard works with regard to defects caused by a manufacturing process gone awry that produces unintended results, this consumer expectation standard is more difficult to apply to other defects such as design defects and defects resulting from misinformation or inadequate warnings. Id. at 1145. The court pointed out that certain commentators have suggested that the consumer expectation test should be rejected, especially with regard to design defects, "in favor of a test that would weigh the utility of the design versus the magnitude of the inherent risk." Id. The Cassisi Court did not reach the issue of whether the utility versus risk test should be adopted in addition to the consumer expectation test for design defects. Id. at 1146.

Although it has not done so yet, this Court believes that the Florida Supreme Court would adopt such risk-utility test. See Pulte Home Corp., 804 F.Supp. at 1487. In rejecting the patent danger doctrine, the Florida Supreme Court implicitly approved, in dicta, this type of balancing approach. See Auburn Machine Works Co., Inc., v. Jones, 366 So.2d 1167 (Fla.1979). In addition, the Florida Supreme Court authorized the publication of an expanded jury instruction concerning product liability that included both the consumer expectation test and the risk-benefit test; [FN243] however, the court has not yet decided any question of law or the correctness or applicability of the charge in any particular case. In re Standard Jury Instructions, 435 So.2d 782 (Fla.1983). [FN244] Finally, in Radiation Technology, Inc., v. Ware Construction Co., 445 So.2d .329 (Fla.1983), the Florida Supreme Court indicated that a balancing test would be appropriate in determining whether a product was defective. [FN245]

FN243. It used the term "benefit" instead of "utility."

FN244. The comment section to the instructions cites favorably to Cassisi v. Maytag Co., 396 So.2d 1140 (Fla.Dist.Ct.App.1981), and states that "[a]bsent more definitive authority in Florida, the committee recommends neither test to the exclusion of the other and expresses no opinion about whether the two charges should be given alternatively or together." In re Standard Jury Instructions, 435 So.2d 782, 784 (Fla.1983).

FN245. The Florida Supreme Court stated: The term "unreasonably dangerous" more accurately depicts liability of a manufacturer or supplier in that it balances the likelihood and gravity of potential injury against the utility of the product, the availability of other, safer products to meet the same need, the obviousness of the danger, public knowledge and expectation of the danger, the adequacy of instructions and warnings on safe use, and the ability to eliminate or minimize the danger without seriously impairing the product or making it unduly expensive. Thus, an unsafe product, whether it be characterized as inherently dangerous or unavoidably dangerous, would not necessarily be an unreasonably dangerous product. Radiation Technology, Inc., v. Ware Construction Co., 445 So.2d 329, 331 (Fla.1983).

This second test, utility or benefit versus risk, is limited to a claim for design defect sounding in strict liability. See Pulte Home Corp., 804 F.Supp. at 1487. This test enables the plaintiff to raise a presumption that the product was defective by showing that the product malfunctioned during normal operation. See Cassisi, 396 So.2d at 1145-46; Humphreys, 839 F.Supp. at 828-29. The defendant may then rebut this presumption of defectiveness by showing that the utility or benefit of the design outweighs the risks inherent in the design. [FN246] See Cassisi, 396 So.2d at 1145- 46; Pulte Home Corp., 804 F.Supp. at 1487.

FN246. With regard to this risk-benefit analysis, Professor Keeton has stated: A product is defective if it is unreasonably dangerous as marketed. It is unreasonably dangerous if a reasonable person would conclude that the magnitude of the scientifically perceivable danger as it is proved to be at the time of trial (emphasis in the original) outweighed the benefits of the way the product was so designed and marketed. Pulte Home Corp., 804 F.Supp. at 1487 (quoting P. Keeton, Product Liability and Meaning of Defect, 5 St. Mary's L.J. 30, 37-38 (1973)).

It is not in dispute that MEC manufactured the Surgitek silicone gel filled breast implants with which Plaintiff was implanted on November 21, 1985. The evidence at trial showed that inherent in the design of Plaintiff's implants was the bleeding of low molecular weight liquid silicone gel. This feature was part of the implant design when Plaintiff's implants left the control of MEC. That the implants bled was known to MEC when it placed such implants on the market for sale. The implants were implanted in Plaintiff without substantial change. Plaintiff's expectations were frustrated by the failure of the breast implants to perform as safely as an ordinary consumer would expect when used as intended. An ordinary consumer would not expect that the breast implants would be designed so that the silicone gel within the elastomer shell would continuously leak into the consumer's body after implantation, [FN247] that silicone had been found in lymph nodes after an implant had occurred, 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 MEC had failed to conduct adequate tests to determine the long-term effects of the leaking silicone on the body [FN248] especially in view of the representations by MEC to the medical community within which it focused its sales at the time, 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, that it might be impossible to remove all the silicone gel from the body if an implant were explanted, and that from anecdotal evidence there was a possible association between the implant and silicone connective tissue disorders and adjuvant disease.

FN247. Dr. Kotzin 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 such bleed would continue, not necessarily at the same rate, for the entire time the silicone gel implant was in the woman's body.

FN248. The duty to test "is a subpart of a manufacturer's duty to design a product with reasonable care, and thus is subsumed in the plaintiff['s] claims for defective design and failure to warn." Adams v. Searle & Co., Inc., 576 So.2d 728, 730-31 (Fla.Dist.Ct.App.), rev. denied, 589 So.2d 290 (Fla.1991).

*29 In addition, and alternatively, the implants malfunctioned during normal use in that silicone gel bled slowly from the implants into Plaintiff's body after implantation.

Defendant did not meet its burden to show that the utility or benefit of the design which allows silicone to leak outweighs the risks inherent in such design. 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 because Lynch felt that silicone was biocompatible. 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 "A" were more expensive to produce.

Silicone gel breast implants were selected for sale over other types of implants despite the fact that they would leak silicone gel into the implantee's body, despite the foreign body reaction that results when any foreign material, including silicone gel, is inserted into the body, despite MEC's lack of knowledge and testing of the results of such silicone gel bleed, and despite MEC's knowledge 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.

Based upon either the consumer expectation standard or the burden-shifting risk-benefit/utility standard, the design of MEC's silicone gel breast implant was defective under a strict liability theory.

In a recent opinion, the Fourth District Court of Appeal considered an issue of first impression in Florida whether there is a substantive difference between a claim for failure to warn under a theory of strict liability versus such claim under a theory of negligence. See Ferayorni v. Hyundai Motor Co., 711 So.2d 1167 (Fla.Dist.Ct.App.1998). That court adopted a formulation of the two claims as articulated by the Supreme Court of California in Anderson v. Owens-Corning Fiberglas Corp., 53 Cal.3d 987, 281 Cal.Rptr. 528, 810 P.2d 549, 558 (1991). Id. at 1172. The differences between the two claims, as stated by the Anderson court, is as follows: [F]ailure to warn in strict liability differs markedly from failure to warn in the negligence context. 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. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.

*30 Ferayorni, 711 So.2d at 1172 (quoting Anderson, 281 Cal.Rptr. 528, 810 P.2d at 558). However, the Fourth District Court of Appeal noted that in the formulation of a claim for failure to warn under a theory of strict liability, "manufacturers are not required to warn of every risk which might be remotely suggested by any obscure tidbit of available knowledge, but only of those risks which are discoverable in light of the 'generally recognized and prevailing best' knowledge available." Id.

Under the learned intermediary doctrine, the duty to warn was owed to Plaintiff's physician, Dr. Penn, not to Plaintiff directly. See, e.g., Toole v. McClintock, 999 F.2d 1430, 1433 (11th Cir.), reh'g denied, 11 F.3d 169 (11th Cir.1993). The Eleventh Circuit Court of Appeals has summarized the learned intermediary doctrine in Florida: The learned intermediary rule is a corollary to the rule that a manufacturer of prescription drugs or products discharges its duty to warn by providing the physician with information about risks associated with those products. The manufacturer's duty to warn of drug hazards runs to the physician, not directly to the patient. The learned intermediary rule provides that the failure of the manufacturer to provide the physician with an adequate warning of the risks associated with a prescription product is not the proximate cause of a patient's injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated. Thus, the link between a patient's injury and the alleged failure to warn is broken when the prescribing physician had "substantially the same" knowledge as an adequate warning from the manufacturer should have communicated to him. Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192 (11th Cir.1995) (citing Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104, 105 (Fla.1989); Zanzuri v. G.D. Searle & Co., 748 F.Supp. 1511, 1517 (S.D.Fla.1990); Tatum v. Schering Corp., 795 F.2d 925, 928 (11th Cir.1986)), reh'g denied, 65 F.3d 185 (11th Cir.1995). The "adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony." Upjohn Co. v. MacMurdo, 562 So.2d 680, 683 (Fla.1990).

Since silicone gel breast implants were classified as medical devices and not as drugs, they were not listed in the Physicians Desk Reference. Therefore, warnings of the product's dangers could be made through advertising, through discussion at medical meetings and seminars, through the contacts with physicians by the sales force of the manufacturer, and through package inserts. MEC chose advertising and package inserts as the way to communicate the problems and benefits of its breast implants. [FN249]

FN249. As noted supra, 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. 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 on the implants and the package insert did not represent that it was a complete list of complications.

By November of 1985 when Plaintiff was implanted, MEC knew that silicone gel bled from its implants after implantation, 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 MEC had failed to conduct adequate tests to determine the long- term effects of the leaking silicone on the body, [FN250] 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. Despite the foregoing knowledge of the risks of gel bleed and the lack of testing at the time MEC marketed its implants, the package insert accompanying Plaintiff's implants did not warn Dr. Penn of gel bleed. [FN251] 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, silicone gel particles may remain in her body. Finally, the package insert did not warn of the possibility of the migration of silicone gel from gel bleed to other parts of the body. [FN252] This failure to warn of gel bleed, that such gel bleed may remain in the body after explantation, and that such gel bleed may migrate to other parts of the body also rendered Defendant's silicone gel breast implant product defective under a strict liability theory. Such risks were known or knowable to MEC in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.

FN250. As noted earlier in this opinion, prior to the sale of its silicone gel breast implants, there was no testing by MEC to determine (1) the effects of silicone gel on the body's immune system, whether from gel bleed, rupture, or degradation of the implant, (2) the effects of migrating silicone gel on the body, (3) the amount of silicone gel bleed that occurs in the body, or (4) the life expectancy of a silicone gel breast implant. MEC disseminated information to the public and to physicians using its silicone gel breast implant product stating that a committee would study capsule formation and the part played by silicone gel in such phenomenon, silicone gel migration and its interaction with various tissues of the body, and the resultant pathology and toxicology of tissues that interfaced with silicone gel breast implants. These studies were never undertaken by MEC. The beagle research study resulted in adverse findings or abnormalities in the liver, kidney, thyroid, and lymph nodes of some beagles. MEC's sales literature sent to physicians misrepresented the length and findings in the beagle study.

FN251. Plaintiff's Exhibit 1.77.

FN252. As a complication of the implants, the package insert states: Potential of shell rupture during surgery or even well after surgery (e.g., spontaneously caused by unknown etiology or caused by external trauma-- stress--forces). Ruptured implants, as well as all the gel contents, must be removed because of possible extravasation of the gel. If this phenomenon does occur additional surgery may be required to remove the gel. Plaintiff's Exhibit 1.77 at 7. While the foregoing warns of possible "extravasation," or pouring forth into surrounding tissues, of gel in the case of rupture of the implants, nowhere does it warn of the fact that silicone gel continuously leaks from the implants after implantation and that this leaking gel may migrate to other areas of the body.

*31 In addition, also by November of 1985, MEC knew of, or it was knowable in light of the generally recognized and prevailing best scientific and medical knowledge available, the probability and extent of capsular contracture, [FN253] the possibility and extent of distortion of the breast from capsular contracture, the possibility and extent of increase in gel bleed from movement of the human body, massage, or closed capsulotomy, the probability that upon removal of the implant natural breast tissue would be lost, and the extent of the scars left by 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. [FN254] The package insert did not warn of increased gel bleed from movement or closed capsulotomy. While 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 implant's bulging against the skin. The package insert did not warn of the loss of breast tissue in the event of explantation. [FN255] Finally, the package insert did not adequately warn of the scarring and numbness of the breast that could result upon explant. [FN256] Failure to adequately warn of the foregoing risks rendered MEC's silicone gel breast implant product defective under a strict liability theory.

FN253. As referenced earlier, Dr. Busch testified that the first definitive work published on capsular contracture appeared in 1981, although there were earlier published reports, and stated that capsular contracture occurs in up to 90% of patients receiving breast implants. Dr. Shons stated that capsular contracture is known to occur in up to 80% of silicone gel breast implant patients, with wide variations which may cause deformity necessitating reoperation or removal.

FN254. 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 withpotential gel extravasation. Plaintiff's Exhibit 1.77 at 7.

FN255. Plaintiff's Exhibit 1.77 at 7.

FN256. The package insert states: Hypertrophic scarring and loss of/or diminished nipple sensation have been reported. Plaintiff's Exhibit 1.77 at 7. Defendant has failed to carry its burden to prove its learned intermediary defense in that the evidence fails to show that Dr. Penn knew or should have known of these risks.

Although Dr. Penn 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, the evidence reflects that this knowledge occurred after Plaintiff had been implanted. 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. At the time of Plaintiff's implantation, Dr. Penn testified that 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. [FN257] 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. [FN258]

FN257. See supra note 11.

FN258. The parties have not argued the impact this later derived knowledge of Dr. Penn has on Plaintiff's damages, a particularly difficult issue as such knowledge of Dr. Penn occurred after the implants had been surgically inserted into Plaintiff.