Fw: Bell Recommendations-1992

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----- Original Message ----- From: Myrl Jeffcoat

myrlj@...

Sent: Tuesday, October 15, 2002 7:56 PM

Subject: Bell Recommendations-1992

The following document has been sent to us by Pam Dowd. . .It is from the breast implant litigation files and documents. Thank you Pam, for sending our way.

Myrl

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This document has been retyped. One portion of the letter did not copy with the scanner for the CDs and has been noted. Due to the blurry nature of the document, phone numbers have been left off this typed copy.

King & Spalding

181 Peachtree Street

ATLANTA, GEORGIA

October 27, 1992

Members

Dow Corning Board of Directors

2200 West Salsburg Road

Midland, Michigan 48686-0994

Re: Dow Corning Silicone Gel

Breast Implant Investigation

Gentlemen:

In January 1992, Dow Corning Corporation retained B. Bell and King & Spalding to conduct an investigation of Dow Corning’s development, production and marketing of silicone gel breast implants. We were asked to develop recommendations for Dow Corning based on the investigation. This document sets forth the recommendations that we now make to Dow Corning. These recommendations address Dow Corning’s commitment to continue to make available information related to health and safety issues raised by silicone gel breast implants for the benefit of women with implants, their physicians, the Food and Drug Administration (“the FDA”) and the public. We believe that these Recommendations when implemented constitute and appropriate response to that commitment. Since Dow Corning permanently withdrew from the production and marketing of breast implants during the course of the investigation, these recommendations do no embrace business management. The Recommendations are strictly for the benefit of Dow Corning, and are not offered in any way to induce any person or entity to take or to forego any action with respect to Dow Corning.

Recommendation No. 1

During the course of the investigation, King & Spalding obtained from Dow Corning approximately 300,000 documents “the Dow Corning documents”) concerning breast implants, including documents relating to complaints, FDA communications, MDR filings, lot histories, product development, saline inflatable (Varifil) implants, studies, tests, and ASTM standard for breast implants, and a variety of other matters. King & Spalding was given free access to review and select the foregoing materials, with the understanding that any materials deemed to be protected by the attorney-client privilege or work product

doctrine were to be returned to Dow Corning. Dow Corning should make the non-privileged Dow Corning documents available to the FDA and should also include the same as a source of documents for potential production in the pending multi-district proceedings.

Recommendation No. 2

Dow Corning should provide to the FDA and the presiding judge in the pending multi-district litigation a list of the names of all witnesses interviewed by King & Spalding during the course of the investigation.

Recommendation No. 3

Dow Corning should continue to review complaints received to assure that Dow Corning reports all events that are required to be reported under the FDA’s current interpretation of the MDR regulations.

Recommendation No. 4

Dow Corning should retain an independent expert to review its production and record keeping practices as well as its program for internal audits of manufacturing practices. The objective of such review would be to assure Dow Corning’s compliance with Good Manufacturing Practices and regulatory requirements applicable to the manufacture of medical devices and medical grade materials currently manufactured by Dow Corning.

Recommendation No. 5

To insure that the FDA’s 1992 inspection of Dow Corning’s breast implant manufacturing facilities is based on a complete record, Dow Corning should advise the FDA (1) that, in violation of company policy and procedures, an unknown number of breast implant lot history records were altered to include replacement oven charts instead of the actual oven charts, (2) that the replacement of charts was discovered in November 1987 and terminated; and (3) that Dow Corning could not determine which lot histories contain replacement charts with the result that the log of atypical lots reviewed by the FDA in 1992 did not refer to the lots containing replacement charts. With respect to lot histories prior to December 1987, Dow Corning records, including the atypical log, should be annotated to recite the facts set forth above. Dow Corning should also release to the FDA the results of its recent testing indicating that these departures from Dow Corning’s policies and procedures did not create a health risk.

Recommendation No. 6

Dow Corning should continue to work with the FDA to determine whether any additional periodic medical monitoring is needed for (last line of this page does not appear on the CD copy)

Recommendation No. 7

Dow Corning should continue its existing Explant Policy of providing financial assistance to Dow Corning breast implant patients when removal of their implants is medically indicated and the patient lacks the financial means to cover the cost of removal.

Recommendation No. 8

Dow Corning should continue to fund medical and scientific studies undertaken to add to the medical and scientific knowledge concerning silicone gel breast implants. The results of these studies should be published for the benefit of women who have breast implants, physicians and the public.

Recommendation No. 9

We recommend that the Chairman of Dow Corning’s Board of Directors ( McKennon), the Medical Director (Dr. Myron on), the Health Care Business Technical Director (Dr. LeVier) or the Epidemiologist (Dr. Ralph Cook) communicated directly (preferably in person) with the experts we interviewed and obtain their perspectives and views in their respective fields on the health and safety effects of silicone gel breast implants.

Our engagement is concluded. We have enjoyed working with you.

Sincerely,

(signed B. Bell by RAS)

King and Spalding

By: B. Bell

/las

NOTE: A telecopied version of this letter was signed by B. Bell and delivered to Dow Corning in Midland, Michigan on October 27, 1992. This hard copy version is being sent to Dow Corning on October 29, 1992, and it was signed for B. Bell by A. Schneider.