Melinda Barrow/16

FN284. 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.

In order to recover damages for fraud or negligent misrepresentation, a plaintiff must prove the following elements: (1) a false statement or omission of a material fact; (2) the representor's knowledge that the representation is false, [FN285] lack of knowledge by the representor as to the truth or falsity of the representation, or that the representation was made under circumstances in which the representor ought to have known of its falsity; (3) the representor's intention that the representation induce another to act on it; and (4) injury to the Plaintiff as a consequence of justifiable reliance on the representation. See, e.g., Jankovich v. Bowen, 844 F.Supp. 743, 747 (S.D.Fla.1994) (citing Schubot v. McDonalds Corp., 757 F.Supp. 1351, 1355 (S.D.Fla.1990), aff'd, 963 F.2d 385 (11th Cir.1992)); Johnson v. Davis, 480 So.2d 625, 627 (Fla.1985); Lance v. Wade, 457 So.2d 1008, 1011 (Fla.1984); Young v. Johnson, 538 So.2d 1387, 1389 (Fla.Dist.Ct.App.1989); Alna Capital Assocs. v. Wagner, 758 F.2d 562, 566 (11th Cir.1985); Godix Equipment Export Corp. v. Caterpillar, Inc., 948 F.Supp. 1570, 1584 (S.D.Fla.1996), aff'd, 144 F.3d 55 (11th Cir.1998); In re Checkers Securities Litigation, 858 F.Supp. 1168, 1179 (M.D.Fla.1994); Pulte Home Corp., 804 F.Supp. at 1483. Fraud can "arise from circumstances which indicate concealment or nondisclosure of a material fact where the buyer does not have an equal opportunity to become apprised of the material fact, or where the seller has the duty to speak." Pulte Home Corp., 804 F.Supp. at 1483.

FN285. " 'The elements for negligent misrepresentation are those for a fraud claim, except that it does not require the element of knowledge to establish scienter." ' Butterworth v. Quick & Reilly, Inc., 998 F.Supp. 1404, 1411 (M.D.Fla.1998) (quoting In re Cascade Intern. Securities Litigation, 840 F.Supp. 1558, 1584 (S.D.Fla.1993)).

*43 Defendant MEC misrepresented through advertising and marketing the limited testing done with regard to its silicone gel breast implants and failed to disclose that no testing had been done to determine the effects of gel bleed on the body. In addition, the package insert that accompanied Plaintiff's breast implants did not disclose the lack of testing done by MEC as to the effects of silicone gel on the body and misrepresented the complications associated with the implants. MEC either knew that its representations were false, lacked knowledge as to the truth or falsity of the representations, or made the representations under circumstances in which MEC ought to have known of their falsity.

Without testing as to the long-term effects of silicone gel on the body, MEC represented in the package insert accompanying Plaintiff's implants that the "[s]ilicone materials used in the production of these products [the implants] are among the most nonreactive implant materials known for this application." [FN286] The sales literature published by MEC stated:

FN286. Plaintiff's Exhibit 1.77 at 3.

Long Term Implant Studies in Dogs: Materials used in the SURGITEK Mammary Implant are subjected to implant evaluations in dogs for periods up to seven years. Test animals are given frequent physical examinations for determination of untoward results such as carcinogenic reaction. Specific animals are sacrificed annually with complete histopathic examinations of the implant sites, the implanted prothesis and 15 to 18 body organs. Those materials implanted into dogs to date have elicited no adverse reactions or carcinogenic activity, (up to 45 months insitu time). [FN287]

FN287. Plaintiff's Exhibit 7.59.

Although the beagle research did span a seven-and-one-half-year period, contrary to the public representations made by MEC in its sales literature, no dog was implanted for seven years, [FN288] and adverse findings or abnormalities were found in the liver, kidney, thyroid, and lymph nodes of some beagles in this study, particularly in Dog 450R and Dog CC74. These adverse findings were not disclosed by MEC. [FN289]

FN288. Stith admitted that no dog in the beagle study had material implanted for 84 months, and he had no other evidence that anyone did a seven-year dog study on the materials in the Surgitek mammary implants, whether they contained General Electric or Dow Corning components.

FN289. Lynch agreed the adverse findings were inconsistent with MEC's published statement that all biocompatibility testing of MEC's breast implant materials was universally negative and other statements contained in printed information which MEC provided its sales representatives to convince doctors to buy its implants. See Plaintiff's Exhibit 7.59; Deposition of Lynch at 1885 & 1891-95. For instance, the sales literature of MEC in 1974 stated that the implants had been tested in dogs for periods up to seven years with no adverse reaction when at that time no dog had been implanted for seven years and there had been adverse findings. Deposition of Lynch at 1896-98. Lynch agreed these statements were false at the time they were made. Further, there was no follow-up system of user response to provide data necessary to ongoing product safety programs and to assure users that Surgitek breast implants were safe for long-term use as stated in MEC's sales literature except for sporadic physician complaints and returns of implants by physicians to MEC. Id. at 1899- 1900. No formalized follow-up system was put in place by MEC to determine adverse reactions in women implanted with MEC breast implants. Id. at 1901, 1908-16 & 2910-13; see also Plaintiff's Exhibits 7.92 & 7.43. Lynch testified he felt these written statements disseminated to physicians and others exaggerations but that MEC still had a good, biocompatible product. Deposition of Lynch at 2528-31.

In October of 1978, Lynch confirmed to MEC the finding of silicon in the tissue samples from selected organs of dogs CC74 and 450R in the study. [FN290] On July 17, 1979, Lynch sent Sanders, President of MEC, an interoffice memo stating that two dogs receiving long-term silicone implants showed low but definite concentrations of silicon in selected organs with highest concentrations of silicon being found in their kidney and liver tissues. [FN291] Lynch recommended that the dogs' tissues be examined by Molecular Optics Laser Examiner ("MOLE"), which could differentiate between silicon compounds at a cost of not more than $850 to MEC. [FN292] Instead, the dogs' tissues were destroyed, and the beagle study was abandoned by MEC in favor of conducting less expensive and shorter ninety-day rabbit studies. [FN293]

FN290. Defendant's Exhibit 743.

FN291. Defendant's Exhibit 704.

FN292. Id.; Deposition of Lynch at 2482-94.

FN293. See Plaintiff's Exhibit 3.146 at 6, dated March 28, 1978; Deposition of Lynch at 2494-2501; Defendant's Exhibits 710 & 738.

Although low concentrations of silicon were found in the organs of certain dogs, no proper follow-up study was done by MEC. [FN294] Lock testified that MEC should have investigated the cause for silicone migration in the dogs' organs, and while she told the FDA about the study, she did not disclose the finding of low amounts of silicone in the distant organs of the dogs. Instead, she only advised the FDA that the dog study was not usable. [FN295] She admitted that the dog studies would not be reliable to show safety of MEC's silicone gel breast implant, although that is what was represented by MEC on its package inserts for which she was responsible. [FN296] The adverse findings from the shortened beagle study were never disclosed in MEC's sales literature. [FN297]

FN294. Deposition of Lock at 104-07 & 1316-17.

FN295. Id. at 1322.

FN296. Id. at 1322 & 1429.

FN297. See footnote 132.

*44 Despite MEC's knowledge that silicone gel bled from its implants after implantation, that this design feature was not easily discoverable, that it had failed to conduct adequate tests to determine the long-term effects of the leaking silicone on the body, that the beagle study had resulted in adverse findings with no follow-up studies being conducted, 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, 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, MEC's package insert accompanying Plaintiff's implants failed to disclose gel bleed or the risks associated therewith. In fact, the package insert indicated that even if the gel were to escape the elastomer shell through rupture, it would not migrate by stating: "The cohesive gel formulation provides an even consistency that resists traumatic displacement of the gel even if the implant is accidentally ruptured." [FN298] The package insert omitted mention of any foreign body reaction that might be caused by the escaping silicone gel. [FN299] In addition, the package insert did not inform of the fact that even if the patient had the implants removed, silicone particles may remain in her body.

FN298. Plaintiff's Exhibit 1.77 at 3.

FN299. The package insert states in the "Handling the Prosthesis" section that silicone materials used in the production of these products are among the most nonreactive implant materials known for this application. Great care has been taken to keep them free from contaminants such as dust, lint and oil. Such contaminants can cause foreign body reactions (e.g., fluid and fibrous tissue buildup) Plaintiff's Exhibit 1.77 at 3. While this paragraph warns of foreign body reactions due to contaminants of the implants, it conspicuously makes no mention of the foreign body reaction that occurs when the foreign material of silicone gel is allowed to seep into the tissues of the body.

A reasonable person would want to know about gel bleed and the risks associated with it before she consented to the implant of MEC's silicone gel breast device. Plaintiff did not have an equal opportunity to become apprised of these material facts. Such information was material to Plaintiff's ability to make an informed decision as to whether to have breast implants.

The package insert also misrepresented capsular contracture, including distortion of the breast from capsular contracture, and omitted the fact that, upon removal of the implant, natural breast tissue would be lost. In addition, it omitted warning of scarring upon explant and breast numbness upon explant. 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 or the possibility and extent of distortion of the breast resulting from such contracture. Such representations as to capsule contracture were made under circumstances in which MEC ought to have known of their falsity. In addition, the omission of the fact that natural breast tissue would be lost upon explant was made under circumstances in which MEC ought to have known that it would create a misunderstanding as to the risks associated with the implants. Finally, omission of the facts that significant scars would result upon explantation and that numbness of the breast could result upon explantation were made under circumstances in which MEC ought to have known that it would create a misunderstanding as to the risks attendant to implantation.

*45 Defendant intended to induce reliance upon such misrepresentations and omissions by both physicians and their patients. The fact that MEC made the misrepresentations, and omitted material information in its representations, to Plaintiff's physician and not directly to Plaintiff does not preclude recovery by Plaintiff against MEC for such misrepresentations and omissions. See Albertson v. Richardson-Merrell, Inc., 441 So.2d 1146, 1150 (Fla.Dist.Ct.App.1983) (finding that plaintiff who injested the drug Bendectin prescribed by her physician could maintain an action for fraud directly against the manufacturer of the drug and its sales representative when they had failed to disclose material information or had made material misrepresentations to the physician), pet. for rev. denied, 451 So.2d 850 (Fla.1984). MEC's intent was to induce physicians to recommend use of its implants to their patients and, in fact, to induce such use by the patients. MEC knew that the physicians' patients, the ultimate users of its breast implants, would rely upon the misinformation MEC had provided to the patients' physicians.

It is clear from the evidence presented at trial that in choosing to become implanted with MEC's silicone gel breast implants, Plaintiff did in fact justifiably rely upon the information she learned about the breast implants from her doctor. Dr. Penn's misinformation, or his lack of information, which he imparted to Plaintiff, was due to MEC's misrepresentations and omissions; Dr. Penn did not have independent knowledge of the matters misrepresented or omitted. [FN300] Plaintiff testified that after her first meeting with Dr. Penn to learn about breast implants, she understood that silicone gel breast implants were "safe". Plaintiff testified that Dr. Penn told her that if the implants ruptured and the gel came out, it would not "hurt" her. Plaintiff testified further that Dr. Penn warned her of the possibility of scar tissue forming after implantation. However, Plaintiff testified that no one ever informed her that the silicone gel inside the elastomer shell of her implants would leak after implantation causing a continuous foreign body reaction and chronic inflammation, and possibly other problems.

FN300. While Dr. Penn did at some point become informed of gel bleed and knew that such bleed, as a foreign material inserted into the body, could cause a foreign body reaction and failed to inform Plaintiff of these facts, he did not have this information at the time of Plaintiff's implantation.

As a consequence of justifiable reliance on the misrepresentations and omissions of Defendant, Plaintiff suffered damages. Relying upon the misinformation given to her by her doctor, Plaintiff chose to be implanted with MEC's silicone gel breast implants. As a consequence, Plaintiff suffered a chronic foreign body reaction to the leaking silicone gel. She had inflammation of tissue in her breast area. After implantation Plaintiff suffered severe capsular contracture, on numerous occasions she had to undergo closed capsulotomies, and one of Plaintiff's implants became deformed and produced the appearance of a bulge on her breast. She also suffered continuous foreign body reaction and chronic inflammation. She had an explant operation performed. Silicone gel remained in her breast tissue area and in her lymph nodes even after explantation. A significant amount of breast tissue was removed from Plaintiff upon explantation, and she has permanent scars on her breasts from removal of the implants, the capsular contracture, and adjacent breast tissue. She also suffers numbness in her breasts after explantation. Accordingly, Plaintiff is owed monetary damages to compensate for such injuries.

*46 Plaintiff asserts claims for breach of express warranty and for breach of the implied warranties of merchantability and fitness for a particular purpose. [FN301] In Florida, to recover under theories of breach of express or implied warranties, the plaintiff must be in privity of contract with the defendant. See, e.g., T.W.M. v. American Medical Systems, Inc., 886 F.Supp. 842, 844 (N.D.Fla.1995) (citing Kramer v. Piper Aircraft Corp., 520 So.2d 37 (Fla.1988); West v. Caterpillar Tractor Co., 336 So.2d 80 (Fla.1976)). "A plaintiff who purchases a product, but does not buy it directly from the defendant, is not in privity with that defendant." T.W.M., 886 F.Supp. at 844 (citing White & Summers, Uniform Commercial Code § 11-2, at 528 (3^rd ed.1988)). Plaintiff has not proven that she was in privity of contract with MEC, and therefore she is not able to maintain claims for breach of warranty, whether express or implied, against it.

FN301. It appears that Plaintiff withdrew her breach of warranty claims. Nevertheless, in an abundance of caution, the Court will consider the merits of such claims.

Plaintiff attempts to assert claims under 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. Neither Act provides for a private right of action by Plaintiff. See T.W.M., 886 F.Supp. at 844-45.

One of the stated purposes of the Florida Drug and Cosmetic Act is to "safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics." Fla. Stat. § 499.002(1) (1997). Section 499.004 provides that the "Department of Health and Rehabilitative Services shall administer and enforce ss. 499.001-499.081 to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics." Fla. Stat. § 499.004 (1997). The penalties and remedies section of the Act provides the Department of Health and Rehabilitative Services with the authority to seek injunctions, impose administrative fines, and issue emergency orders for violations of the Act. Fla. Stat. § 499.066 (1997). Nowhere does the Act state that it provides for a private cause of action by an individual, and Plaintiff has provided no authority supporting implication of such private cause of action.

In this suit, Plaintiff seeks damages for personal injuries. However, the Florida Deceptive and Unfair Trade Practices Act does not apply to "a claim for personal injury or death ...." Fla. Stat. § 501.212(3) (1997).

Based upon the foregoing, Plaintiff's claims under the Florida Drug and Cosmetic Act and the Florida Deceptive and Unfair Trade Practices Act are dismissed.

Plaintiff is entitled to compensatory damages for her chronic foreign body reaction, [FN302] capsule contracture, breast deformity, permanent loss of breast tissue, permanent scarring due to the explant operation, and numbness of her breasts upon explantation.

FN302. Dr. Penn 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. Thus, Plaintiff's recovery with regard to the foreign body reaction resulting from MEC's failure to warn of gel bleed must be discounted in theory to reflect Dr. Penn's knowledge under the learned intermediary doctrine. Because Dr. Penn could not testify to an exact date when he learned of gel bleed, the Court finds that it is appropriate to use the date when Dr. Penn testified he started using lower bleed implants, 1987. Thus, from the date of implantation until 1987, Plaintiff is entitled to damages for her foreign body reaction to gel bleed under her failure to warn claim. However, no such reduction is necessary with regard to her fraud/negligent misrepresentation claim relating to gel bleed. Although Plaintiff has met the elements for recovery of damages under theories of strict liability, negligence, and fraud/negligent misrepresentation, no double recovery for the same injury shall be allowed.

*47 The record contains little evidence as to specific monetary damages suffered by Plaintiff. The parties' Pretrial Statement [FN303] noted the following monetary damages suffered by Plaintiff:

FN303. (Doc. No. 131 at 7-8).

FN304. The Pretrial Statement was completed before the parties agreed to have this action tried to the Court.

Special Damages $ 100,000

Medical Expenses $ 100,000

Loss of Wages $ 250,000

Future Medical Expenses $ 250,000

Future Loss of Capacity to Earn $4,000,000

Pain and Suffering--Amount to be determined by jury [FN304]

FN304. The Pretrial Statement was completed before the parties agreed to have this action tried to the Court.

The foregoing amounts are not helpful to the Court in determining an appropriate award of damages because the amounts claimed apparently lump "systemic" damages together with "local" damages.

Included in the record is a stipulation between the parties as to damages. [FN305] In this stipulation, the parties agreed that plaintiff was charged the following medical expenses, which she claims (and Defendant denies) are attributable to her "local" medical claims in this case. The stipulation states that the expenses were fair and reasonable but that Defendant denies responsibility for any of the charges. The stipulation stated the local medical charges as follows:

FN305. Stipulation regarding medical expenses and charges by Plaintiff Melinda Barrow, Defendant Bristol Myers, Defendant Medical Engineering (Doc. No. 206, filed in open court on December 19, 1997).

Dr. Fabian Worthing $4,050.00

Tops Surgical Specialists $2,140.00

Eckerd Drugs $286.47

Walgreen Drugs $ 14.19

Dr. Sandra Houston $200.00

The stipulation stated the local non-medical bills as follows:

Delta Airlines $412.00

Holiday Inn--Houston, Texas $360.28

La Quinta Inn $ 59.41

Budget Car Rental $ 47.29

With regard to these so-called local non-medical charges, the parties agreed that Plaintiff's father paid the foregoing bills and that the bills are authentic. In addition, Defendant stipulated that the local non-medical bills were related to Plaintiff's explantation of her breast implants, although Defendant denies that it is in any way responsible for these bills.

The Court finds that Plaintiff should be compensated for the foregoing local medical and non-medical charges relating to explantation for a total amount of $7569.64. The Court also finds that Plaintiff is entitled to significant pain and suffering damages for her past and future physical pain and mental anguish associated with the chronic foreign body reaction, capsule contracture, breast deformity, and for the permanent loss of breast tissue, permanent scarring from the explantation and breast numbness upon explantation. She is also entitled to an award for her loss of capacity to earn both past and future. [FN306]

FN306. Notwithstanding the foregoing, Plaintiff has not proven that she is incapable of attaining employment in the future.

The purposes of punitive damages are to punish and to deter. See, e.g., American Cyanamid Co. v. Roy, 498 So.2d 859, 861 (Fla.1986). Generally, "punitive damages are appropriate when a defendant engages in conduct which is fraudulent, malicious, deliberately violent or oppressive, or committed with such gross negligence as to indicate a wanton disregard for the rights of others." W.R. Grace & Co. v. Waters, 638 So.2d 502, 503 (Fla.1994).

A fraud claim sufficient to support an award of compensatory damages is also sufficient to support an award of punitive damages. See, e.g., First Interstate Dev. Corp. v. Ablanedo, 511 So.2d 536, 538-39 (Fla.1987); Perlman v. Prudential Ins. Co. of Am., Inc., 686 So.2d 1378, 1382 (Fla.Dist.Ct.App.), rev. denied, 697 So.2d 512 (Fla.1997); Cruise v. Graham, 622 So.2d 37, 41 (Fla.Dist.Ct.App.1993). "In a non-disclosure case, punitive damages are appropriate only if the most aggravated form of non-disclosure has occurred--that the defendants made a deliberate and knowing concealment designed to cause, and actually causing, detrimental reliance by the plaintiff." Billian v. Mobil Corp., 710 So.2d 984, 992-93 (Fla.Dist.Ct.App.1998) (citations omitted).

*48 The Florida Supreme Court has reaffirmed the standard for awarding punitive damages under a theory of negligence originally set forth in Carraway v. Revell: The character of negligence necessary to sustain an award of punitive damages must be of a "gross and flagrant character, evincing reckless disregard of human life, or of the safety of persons exposed to its dangerous effects, or there is that entire want of care which would raise the presumption of a conscious indifference to consequences, or which shows wantonness or recklessness, or a grossly careless disregard of the safety and welfare of the public, or that reckless indifference to the rights of others which is equivalent to an intentional violation of them."White Constr. Co., Inc., v. DuPont, 455 So.2d 1026, 1029 (Fla.1984) (quoting Carraway v. Revell, 116 So.2d 16, 20 n. 12 (Fla.1959)). "The character of negligence necessary to sustain an award of punitive damages is the same as that required to sustain a conviction for manslaughter." Chrysler Corp. v. Wolmer, 499 So.2d 823, 824 (Fla.1986) (citing Carraway, 116 So.2d at 20); see also American Cyanamid Co. v. Roy, 498 So.2d 859 (Fla.1986).

Plaintiff has argued that the applicable punitive damages standard is that presented in Johns-Manville Sales Corp. v. Janssens, 463 So.2d 242 (Fla.Dist.Ct.App.1984), rev. denied, 467 So.2d 999 (Fla.1985). In Johns- Manville, the court stated that a legal basis for punitive damages is established in products liability cases where the manufacturer is shown to have knowledge that its product is inherently dangerous to persons or property and that its continued use is likely to cause injury or death, but nevertheless continues to market the product without making feasible modifications to eliminate the danger or making adequate disclosure and warning of such danger. 463 So.2d at 249. However, it appears that the Johns-Manville case may have been limited to its facts by the Florida Supreme Court in Chrysler Corp. v. Wolmer. 499 So.2d at 825.

Nevertheless, the evidence presented in this case establishes that an award of punitive damages is appropriate with regard to Defendant's fraudulent failure to disclose gel bleed. Defendant made a deliberate and knowing concealment of the material fact of gel bleed with the design to cause, and actually causing, detrimental reliance by Plaintiff. As a consequence, Plaintiff suffered a chronic foreign body reaction to the leaking silicone gel in the form of inflammation of tissue, and silicone gel particles remained in her breast tissue area and in her lymph nodes even after the explant operation. Accordingly, Plaintiff is entitled to punitive damages in an amount commensurate with Defendant's culpable conduct and Plaintiff's injuries. See BMW of N. Am., Inc., v. Gore, 517 U.S. 559, 574-86, 116 S.Ct. 1589, 134 L.Ed.2d 809 (1996). However, without a showing of causation as to systemic injuries, it cannot be said, based upon the facts of this case, that Defendant exhibited a reckless disregard for human life equivalent to manslaughter by designing and marketing its breast implants. See Chrysler Corp., 499 So.2d at 825. [FN307]

FN307. Furthermore, under the Johns-Manville standard of questionable applicability, MEC was not shown to have knowledge that its breast implant as designed was inherently dangerous to people, and to Plaintiff in particular, and that its continued use was likely to cause injury or death.

IV. DAMAGES AWARD

*49 Plaintiff is entitled to judgment against Defendant MEC on her claims of strict liability, negligence, and fraud in accordance with this opinion as follows:

Local medical and non-medical charges relating to explantation

$ 7,569.64

Compensatory damages $350,000.00

Punitive damages $400,000.00

--------------------------------

TOTAL $757,569.64

The Clerk shall enter judgment in favor of Plaintiff Melinda Barrow and against Defendant Medical Engineering Corporation in this amount.

All issues and claims not addressed herein are found to be without merit. In addition, all remaining pending motions are rendered moot by rulings at trial and this opinion.

END OF DOCUMENT