Melinda BARROW, Plaintiff,
v.
BRISTOL-MYERS SQUIBB CO. and MEDICAL ENGINEERING CORP. Defendants.
No. 96-689-CIV-ORL-19B.
United States District Court, M.D. Florida.
Oct. 29, 1998.
ORDER
FAWSETT, District J.
I. STATEMENT OF THE PROCEEDINGS
TABLE OF CONTENTS
Page Number
I. STATEMENT OF THE PROCEEDINGS 1
II. FINDINGS OF FACT 3
A. THE PLAINTIFF 3
B. DEFENDANT'S SILICONE GEL BREAST IMPLANT 35
C. EFFECTS OF MEC'S IMPLANTED SILICONE GEL BREAST DEVICE 72
1. Gel Bleed 73
2. The Foreign Body Reaction 80
3. Migration of Silicone Gel Molecules From Gel Bleed 86
4. Systemic Silicone Disease 102
D. MEC'S FAILURE TO WARN 119
E. REMOVAL OF THE SILICONE GEL BREAST IMPLANTS 123
III. CONCLUSIONS OF LAW 125
A. STRICT LIABILITY 126
1. Design Defect 128
2. Failure to Warn 136
B. NEGLIGENCE 148
1. Design Defect 148
2. Failure to Warn 150
C. CAUSATION 158
1. "Systemic" Injuries 160
2. "Local" Injuries 166
D. DEFENSES 171
1. Assumption of the Risk 171
2. State of the Art Defense 174
E. FRAUD/NEGLIGENT MISREPRESENTATION 177
F. BREACH OF WARRANTIES 187
G. CONSUMER PROTECTION STATUTES 188
H. DAMAGES 189
1. Compensatory 189
2. Punitive 192
IV. DAMAGES AWARD 196
1 Plaintiff, Melinda Barrow ("Barrow") originally filed suit on May 27, 1994 in the United States District Court in the Eastern District of New York against Defendants Bristol-Myers Squibb Company ("BMS") and Medical Engineering Corporation ("MEC"). The case was transferred and docketed in this Court in June of 1996. Plaintiff alleged theories of strict liability, negligence, fraud, failure to warn, breach of warranties, negligence per se, misrepresentation, common plan to prevent public awareness of breast implant hazards, corporate joint venture liability, control and/or supervision of joint ventures, invalidity of indemnification agreements, alter ego liability, and punitive damages with reference to the bilateral implant of silicone gel breast prostheses that she received on November 21, 1985, at the age of eighteen. The two breast implants were designed, manufactured, and marketed by MEC under the name of "Surgitek". They were surgically removed at Plaintiff's request on April 7, 1994. Plaintiff claims that her silicone breast implants caused her to suffer autoimmune and neurological disease, as well as local injuries, due to her exposure to silicone, silica, and other chemicals and by-products through the bleeding of low molecular weight silicone gel through the silicone elastomer shell of the implant. Defendants denied Plaintiff's claims, asserting, inter alia, that the implants were not defective, that they did not cause any of the health problems of which Plaintiff complains, and further that the implants were accompanied by a package insert when sold to the implanting plastic surgeon, Dr. John Graham Penn, who while acting as a learned intermediary gave Plaintiff information about the surgery and obtained her consent before the implant procedure was performed. [FN1]
FN1. Pretrial Statement pursuant to Local Rule 3.06(c), Docket No. 131, filed on October 20, 1997.
Barrow is a citizen-resident of the State of Florida. Defendants BMS and MEC are citizens of the state of Delaware with their principal places of business located in New York and Wisconsin, respectively. The case was brought pursuant to the Court's diversity jurisdiction. The case was tried to the Court sitting as jury from November 10, 1997 to December 10, 1997 pursuant to waiver of jury trial entered by all parties. [FN2] During the course of the trial, Plaintiff discontinued her claims against BMS with prejudice, which action was subsequently reduced to writing as a stipulation between these two parties. [FN3]
FN2. Doc. Nos. 164 & 174 (filed November 3, 1997, and November 4, 1997, respectively).
FN3. Joint Motion by Plaintiff and Defendant (Stipulation), Doc. No. 268, filed December 22, 1997, endorsed as approved by the Court on December 31, 1997.
II. FINDINGS OF FACT
A THE PLAINTIFF
Melinda Barrow was born on February 16, 1967. She was described by her mother, Mollie Barrow, as a happy, healthy, very loving child who had many friends and a relatively uneventful, normal development as a child and adolescent. During her childhood, she skipped many of the usual childhood diseases such as mumps, chicken pox, and measles, and she did not have allergies or regular infections or fatigue. She had the normal developmental milestones for a child, had the usual vaccinations administered by her pediatricians, and had a good appetite resulting in her weight being appropriate to her physique as she developed. Mrs. Barrow described her daughter during this time as self-confident, active, and energetic, a person who enjoyed family and friends, and a good, average student who made mostly "B's" and some "C's" after she began attending Deland High School in the tenth grade.
2 In high school Melinda Barrow pursued a dream of becoming a model. She undertook modeling assignments and had professional photographs taken to build her portfolio. [FN4] Her mother described her as being very diligent at her modeling jobs. At age sixteen, she was chosen to be featured on the cover of Central Florida Magazine. [FN5]
FN4. E.g., Plaintiff's Exhibits 1.1(a), (d), & (g-j).
FN5. Plaintiff's Exhibit 1.1(b). Plaintiff's mother testified that at this time, her daughter was 5'9" tall and weighed 115 pounds.
In the eleventh grade, when Plaintiff realized that she needed only three credits to graduate, she enrolled in a local community college over the summer and obtained her high school diploma in August of 1984. [FN6] At this point, having previously signed a modeling contract with Cassandra Carrigan's modeling agency in Orlando, Florida, Melinda Barrow was ready to pursue an international modeling career.
FN6. Plaintiff's Exhibit 1.1(c) is a photograph of Plaintiff during this period of time when her mother stated that the normal weight of her daughter was generally between 115 and 120 pounds and did not fluctuate much.
In January of 1985 Plaintiff, who was then only seventeen years old, flew to Paris alone for several months to work as a model. She returned home to Deland, Florida in April for a short visit and then traveled back to Paris for two months before returning again to the United States to model in Orlando and Atlanta over the summer and fall of that year. [FN7] While in Paris, Plaintiff wrote to her mother about having breast implant surgery because she felt it would enhance her career opportunities. [FN8]
FN7. See, e.g., Plaintiff's Exhibits 1.1(e) & 7.
FN8. Defendant's Exhibits 1214(a) & (b).
In the fall of 1985, Melinda Barrow and her mother consulted with Dr. John Graham Penn, a plastic surgeon located in Winter Park, Florida, concerning the implant operation. Much of the testimony of Dr. Penn, Plaintiff, and Mrs. Barrow is consistent as to what occurred at this meeting. Mollie Barrow stated that Dr. Penn showed them a silicone gel breast implant by putting it on the table and stated that the procedure was relatively simple, that one could expect there would be no complications, and that it consisted of inserting the implant through a small incision below the breast which would leave a minimal scar. Mrs. Barrow testified that while she did not remember the exact words used by Dr. Penn, he gave no indication that there was any danger and left her with the impression that the implants were safe and should last a long, long time. [FN9]
FN9. Mrs. Barrow related that at the time she had great confidence in doctors and did not think Dr. Penn would tell her daughter to do something that was ill-advised.
Melinda Barrow also described the first meeting she had with Dr. Penn and her mother. She recalls that Dr. Penn said, inter alia, that silicone gel breast implants were safe, and he said either that they would last a long time or that they would last a lifetime. [FN10] He also said that if the implant ruptured and the gel were released, it would not be harmful to her. Plaintiff signed a consent form which contained a list of complications and warnings about the breast implants and implant surgery. [FN11] Plaintiff admits that she knew some of the complications of such surgery. [FN12] However, she testified Dr. Penn did not discuss with her the concept of gel bleed or the issue of any relationship of gel bleed to systemic immune disease. The consent form contains no reference to gel bleed.
FN10. Whatever words Dr. Penn used, Plaintiff stated that he gave the impression that the implants would last a very long time.
FN11. Plaintiff's Exhibit 1.96(a). This document states in part: The following points, among others, have been specifically made clear: a. The operation has been done for several years, but the end results are not, and cannot be determined for a number of years yet to come.
b. Research indicates that the material implanted in the body does not cause malignancy in human subjects.
c. There is a possibility that my body may not tolerate these implants, making it necessary to remove the implants. This occurs in a small percentage of cases.
d. A cyst may form in the area adjacent to the implants, causing fluid accumulation which may require drainage by needle or removal of the implants.
e. The breasts can become firm (capsule formation and contraction). This condition can be permanent and can cause pain and discomfort.
f. No guarantee has been given as to size and shape of the breasts. Good results are expected but not guaranteed.
g. In some patients the margin of the implants can be felt.
h. The incision will heal with a scar which will be permanent.
i. Postoperative bleeding may occur around the implant requiring a second operation for its removal.
j. After being exposed to cold temperatures (i.e. swimming in cold water), the breasts may feel cooler than surrounding body tissues.
k. Pregnancy is not recommended for at least six (6)months after the surgery.
l. Numbness or hypersensitivity of the nipple may be experienced following surgery.m. The procedure is subject to the same postoperative complications as other surgical procedures.
n. 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.
FN12. Plaintiff testified that Dr. Penn described the possibility of hematoma and having an accident causing the elastomer to rupture and the gel to be released in which event, he stated, it would not be harmful or cause any side effects. Dr. Penn explained that the breasts may become cold, that Plaintiff should not become pregnant for six months, and that scar tissue may form around the implants for which he suggested that Plaintiff take Vitamin E and massage.
Reviewing his records, [FN13] Dr. Penn stated he first saw Plaintiff on October 15, 1985. While he did not recall her mother, he stated that he examined Plaintiff, [FN14] gave her information, and discussed the breast implant procedure, including the anesthesia, technique of the operation, and possible complications. [FN15] As to the latter, Dr. Penn stated he discussed with Plaintiff the possibility of problems with wide scars from the implant procedure [FN16], infection and removal of the implants, bleeding of blood and the possibility of having to re-explore the area, hypersensitivity or a numbness sensation in the breasts, slow healing of wounds, discoloration, and contracture associated with the capsule formation around the implant causing distortion, firmness, discomfort, and pain. [FN17] Plaintiff was also advised that she should not become pregnant for at least six months after surgery. Dr. Penn stated that his procedure was to review the consent form with a patient, going over the items verbally, and that his nurse or secretary would also go over the form with the patient at the time the surgery was scheduled. [FN18] Dr. Penn does not believe that he deviated from this procedure with Plaintiff.
FN13. Plaintiff's Exhibit 1.96.
FN14. His photographs of Plaintiff prior to the surgery are Plaintiff's Exhibits 1.58(a-e).
FN15. Dr. Penn wrote a summary of this discussion in his notes for Plaintiff's visit on October 15, 1985. Plaintiff's Exhibit 1.96.
FN16. From the testimony of Mollie Barrow, Plaintiff, and Dr. Penn, it appears this discussion of scars pertained to the scarring from the implant procedure. It does not appear that scarring upon explant was discussed at this meeting of Plaintiff and her mother with Dr. Penn. Mollie Barrow acknowledged that on the initial meeting, Dr. Penn told both her and her daughter that the implant was a relatively simple procedure, would result in a minimal scar from a small incision below the breast to insert the implant, and that no complications should be expected because the procedure was not complicated.
FN17. Dr. Penn related that the capsule is a membrane of scar-like tissue which occurs in a foreign body reaction and forms a sheet of scar tissue over the breast implant.
FN18. On cross-examination, Dr. Penn was questioned about each item on the consent form, and he testified that it was his procedure to go over each item with each patient. However, later in his cross-examination he stated that it was not his routine to explain that in thin patients the edge of the implant may be palpable, even though the consent form warns of such result. Dr. Alan Shons, who testified as an expert plastic surgeon called by Defendant, stated that he had reviewed Dr. Penn's deposition and his records and, in his opinion, Dr. Penn's warnings to Plaintiff were adequate. He dismissed Dr. Penn's failure to warn of gel bleed as being of no clinical significance. Dr. Shon's curriculum vitae is Defendant's Exhibit 1155.
3 Dr. Penn, who had been engaged in private practice as a plastic and reconstructive surgeon since 1974, testified that he could not recall what he may have told Plaintiff about how long the implants would last. It was not routine for him to discuss with his patients the duration of the breast implants unless he was asked, and if asked, his routine was to say that the implants would last a considerable length of time. Further, although he testified that he did not know definitely how long the silicone breast implants would last because they had not been around for too many years, he stated that he thought that they would last for quite a long time and hoped that they would last for a lifetime. [FN19]
FN19. However, he emphatically stated on cross-examination that he did not tell Plaintiff her implants would last a lifetime.
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. [FN20] He noted that the package insert of the breast implant manufacturer did not reference gel bleed. [FN21]
FN20. While testifying that he learned about silicone gel breast implants from a variety of sources such as medical literature and professional meetings and manufacturer's literature, including package inserts, Dr. Penn stated that he did not know when or how he learned about gel bleed. He stated that he either did not read or could not recall if he had read many of the articles in the medical literature he was shown. He testified that he learned of gel bleed in the latter half of the 1980s and began using lower gel bleed implants in 1987. Dr. Penn stated that he believed that the gel bleed would be contained within the tissue capsule. Dr. Shons testified that he also began using the low bleed implants during this time period. Dr. Penn stated that he "probably" explained gel bleed to his patients after he learned about it. He said that he understood that the silicone gel was a medical grade type, a gel that had been developed and checked for safety, and that it was safe for implantation into the human body. When he began using lower gel bleed implants in 1987, this is what he explained to patients about gel bleed. However, despite Plaintiff's several visits to Dr. Penn subsequent to the surgery and until 1993, her complaints of physical problems, and her questions to Dr. Penn about whether the implants could cause these problems, Dr. Penn did not advise Plaintiff of gel bleed or of any of the issues concerning systemic injuries, other than capsular contracture and numbness in the breasts. Instead, he assured Plaintiff that her implants were "OK". By this time, MEC had manufactured a barrier breast implant called the SCL series (Strong Cohesive Low-bleed) which it sampled out to doctors in 1985 and made available for sale in 1986.
FN21. The package insert accompanying Plaintiff's implants is Plaintiff's Exhibit 1.77. The package insert stated the following complications:
Complications may include the risks associated with the medication and the surgical procedure as well as the patient's degree of intolerance to the surgical procedure.
--Potential complications are those associated with the mammary reconstruction or tissue replacement in general.
--Capsule 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.
--Prothesis displacement.
--Hypertrophic scarring and loss of/or diminished nipple sensation have been reported.
--Inadequate tissue covering and/or the use of steroids may result in necrosis and extrusion of the implant.
--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 not occur additional surgery may be required to remove the gel.
--Infection, though infrequent, requires immediate treatment, including but not limited to antibiotics, drainage, and possible implant removal. Wound culture is advisable. Cases of latent infections of unknown etiology have also been noted. Plaintiff's Exhibit 1.77 at 7. Dr. Shons reviewed the package insert for Plaintiff's implants and confirmed that there is no mention of gel bleed.
Dr. Penn stated 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 also 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. He testified that in 1985 he knew very little about gel bleed or the possibility that systemic injuries might be caused by silicone gel breast implants. [FN22] Dr. Penn is certain he did not discuss systemic disease with Plaintiff because he was not aware of any possible relationship between the implants and such disease then.
FN22. Dr. Penn testified that he does not understand the chemistry involved in gel bleed on more than a superficial basis. Later in the trial, Dr. Shons stated that possibly there was a time in which he and other plastic surgeons knew about silicone gel breast implants but did not also know about gel bleed and that he, personally, did not know about gel bleed before 1974.
The implant procedure occurred on November 21, 1985 and lasted one hour during which Plaintiff was placed under local, intravenous anesthesia, Surgitek silicone breast implants were inserted bilaterally, and the areas were closed. Plaintiff was discharged from the outpatient facility the same day after recovery. The surgery was routine and without complications.
Subsequent to the implant surgery, Plaintiff's international modeling career expanded. [FN23] Between 1986 and 1990, she had modeling assignments in many foreign countries such as Germany, Italy, Spain, Japan, and France for many well-known fashion designers and was included in several advertisements. [FN24] During the same period, she began developing persistent and increasing allergies, stomach and sinus problems, regular sore throats, rashes and skin blotches, swollen lymph nodes, sneezing and coughing, and fatigue, pain, burning, and hardening in her breasts, which she had not regularly experienced previously. She also began losing weight. [FN25]