BRISTOL-MYERS/MEC PUNITIVE DAMAGES STORY
ATLA BILG SEMINAR-- 4/21/94
I. MEC placed its breast implants on the market before completing any long-term safety testing.
A. MEC introduces the Perras-Papillon in 1/71 (MEY 378-416)
B. 1971: Huntingdon Research Center rabbit toxicology test results: moderately severe chronic in flammatory responses at intramuscular implant sites. (MEI 145252-61)
C. G.E. tells MEC it does not recommend use of its silicone for non-industrial applications. (MEI149248)
II. MEC represents to customers that it did long-term tests that showed that silicone implants were biocompatible.
A. Dog study documents:
1. MEI 146782; MEO 61627; MED 26314 (adverse results)
4. EMS 56634: 3/28/78. Recommends discontinuing dog studies. Cheaper to do 90 day rabbit studies.
5. MEC 8435: 4/3/78. "Destroy dogs...no organs in freezer".
2. Sanders testimony (MDL 926)
B. Biocompatibility sheets initially claimed dog studies conducted 7 years, no untoward results. See revisions:
1. MEG 4987-90 (1980); MEG 4944-45 (1981) MEG 5035 (10/82) MEG 5022-24 (1983) . 2. See Sanders' and Lynch's MDL testimony
III. By 1975, MEC "state-of-the-art" implant design changed to "high-bleed". MEC knew they bled, prone to rupture.
A. See Sanders, Lynch MDL Depo testimony re: Perras-Papillon and change to thin shell.
B. MEC knew that silicone would bleed, and that nothing would stop it.
1. 2/14/80. Reducing gel bleed is impossible without using non-silicone polymer.(MEM 20716-28) 2. 1981 Lynch paper: even high molecular weight silicone can migrate through shells; some additives may slow rate of bleed, but nothing will stop it. (MEM 10294-99)
3. 1/17/88. Competitive gel bleed tests show that even "low bleed" implants bleed. (MEI64230).
4. 2/91, 12/91. No meaningful long-term gel bleed test has been developed. (MEI 64201-02; BMS 62187)
5. See Lynch MDL Depo
C. Silicone in implants was essentially the same silicone that was used in direct injections.
1. See Lynch MDL Deposition.
IV. Despite reports of migration, MEC represented that its gel was cohesive and would not migrate. A. Reports in the literature:
1. 1/77: Study of Tissue Response to Ruptured Gel-Filled Mammary Prostheses (MED 2676-77) 2. 1978: "Distant Migration of Silicone from a Ruptured Breast Implant (MEA 2449-50).
B. MEC Documents:
1. 12/14/76 "Dear Shel" letter from Sanders (MED 22435-38)
2. 11/79 Reference first made in Package Inserts (MEG 11989-94)
3. 4/8/82 "dear doctor" letter from Sanders. (MEJ 6445)
C. Lynch Testimony: MEC had no data to support its claim ct cohesiveness (Vol. 2, 48232-9)
V. MEC and other manufacturers had the technology to determine the health effects of siiicone but chose not to.
A. 11/77 Ann Arbor meeting; proposal to spend $25,000 to Fund studies such as HLA typing,
immune response, but MEC unwilling to spend money. (MD 114685-87; MEM 406-08; MEM 409-13; MEM 490-93)
B. Docs. re: MOLE analysis of silica cost $750 to assess migration of silicone to brain of dogs.
C. Lynch MDL Testimony: MEC didn't spend the money (Vo1.4, p. 987-90).
VI. After MEC introduced the SCL (low-bleed) implant, it continued to sell high-bleed implants.
A. Georgiade on the market until 1988 (MEY378416);
Dr. Georigade recommends dropping implant; other "low bleed" implants on the market(MEG6739-47)