January 1998

IMPORTANT UPDATED INFORMATION FOR PHYSICIANS ABOUT PATIENTS WITH BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE HEART VALVES

This letter provides new information about the risk of outlet strut fracture for 60 degree Bjork-Shiley Convexo-Concave (BSCC) heart valves and new recommendations from an independent expert panel regarding prophylactic valve replacement. The recommendations are described in detail in the enclosed attachments.

Under the Settlement Agreement that was entered into by a worldwide class of BSCC valve patients and Shiley Incorporated and approved by the U.S. District Court in Cincinnati, Ohio in Bowling v. Pfizer, an independent expert medical and scientific panel consisting of cardiothoracic surgeons, cardiologists, and epidemiologists was created called the Supervisory Panel. Under the terms of the Settlement Agreement, the Supervisory Panel is charged with the responsibilities of conducting studies and research, and of making recommendations regarding which BSCC heart valve patients should be considered for prophylactic valve replacement. The Supervisory Panel's recommendations also serve to determine which class members qualify for explantation benefits under the Settlement Agreement. The Panel's work has enabled it to develop these present guidelines for valve replacement surgery. The Panel's guidelines represent a departure from past reliance upon the valve replacement surgery guidelines developed by a Medical Advisory Panel created by Shiley Incorporated.

Attachments A and B.

The Supervisory Panel's recommendations regarding prophylactic valve replacement are summarized in Attachment A, entitled "Summary of the Supervisory Panel's Prophylactic BSCC Valve Replacement Guidelines." The Panel's recommendations account for valve implant position (aortic vs. mitral), gender and current age of the patient, and patient-specific estimated annual fracture rate.

Table 1 in Attachment A provides certain threshold estimated annual fracture rates above which prophylactic explantation should be considered. If your patient's estimated annual fracture rate is higher than the corresponding rate in the table, the Supervisory Panel recommends that prophylactic explantation be considered. To use the table, you will need to obtain a patient-specific estimated annual fracture rate, as described below, and compare that rate to the rate listed in Table 1 for the patient's gender, valve position, and current age (rounded to the nearest five years).

In order for a Bowling class member to receive monetary benefits from the Bowling Patient Benefit Fund for prophylactic valve replacement, the valve replacement must meet the objective standards set forth in Attachment A. Qualification under these objective standards does not mean that replacement surgery is appropriate for a particular patient, but only that monetary benefits under the Bowling settlement are available should the surgery take place. It should be noted that benefits generally remain available for implantees who undergo explantation in accordance with the prior replacement surgery guidelines (January 1995) developed by the Medical Advisory Panel created by Shiley Incorporated. If you want a copy of the 1995 guidelines, please contact the Claims Administrator.

As discussed above, the recommendations regarding prophylactic valve replacement require the calculation of patient-specific estimated annual fracture rates. Attachment B, entitled, "Summary of Factors and Methodology Used to Calculate 60 Degree BSCC Valve Fracture Rates," sets forth a formula based upon current information that can be used to identify 60 degree BSCC heart valves that may have a significantly greater risk of outlet strut fracture. The Supervisory Panel has identified six risk factors to be used in calculating estimated annual fracture rates for 60 degree BSCC heart valves: valve size, valve implant position (mitral vs. Aortic), weld date, welder identity, valve shop order, and current patient age. This is the first time that two of these risk factors, valve shop order and current patient age, are used in the calculation of estimated annual fracture rates. Because current age must be included in the calculation, estimated annual fracture rates for each patient must be calculated on a case-by-case basis.

In order to obtain the estimated annual fracture rate for a specific patient, or to determine if the patient qualifies for benefits for reoperation under the Settlement Agreement, you will need to communicate the valve serial number, valve implant position, and the patient's gender and current age to the Bowling Claims Administrator. A telephone number, fax number, and mailing address for the Claims Administrator are provided at the end of this letter. A prompt response will be provided, including a copy of the calculation of the estimated annual fracture rate and whether the patient qualifies for the payment of the costs of reoperation.

Attachment C.

Attachment C contains the Supervisory Panel's recommendations and guidelines. That document is intended to provide valve implantees and their treating physicians with additional information that is relevant and important to the explantation decision. For example, it sets forth factors which should be seriously considered by the patient and physician when deciding whether or not explantation of a heart valve identified to be at a greater risk of outlet strut fracture may be beneficial for a particular implantee. The guidelines contain additional information that the Supervisory Panel believes is helpful in the clinical management of BSCC valve patients, so please read them carefully.

Since guidelines development is a dynamic process, the guidelines will be continuously reviewed by the Supervisory Panel as new data become available. They will be modified when appropriate in accord with the best scientific, epidemiological and clinical information made available to the Panel.

The Supervisory Panel's recommendations are based upon the best data available at the present time and are not meant to be absolute recommendations for individual patients. The final decision regarding explantation in an individual patient must be made by the patient in consultation with the treating cardiologist or cardiovascular surgeon, after careful examination and explanation of the available data.

The Supervisory Panel will soon send letters to BSCC valve patients to inform them that new information regarding their heart valve is available. In the letter, we recommend that patients contact their physicians to discuss this new information. The Supervisory Panel encourages you to obtain estimated annual fracture rates for your BSCC valve patients and to speak with them about this new information. Also note that in the event that you or any of your patients disagree with the decision rendered regarding qualification for valve replacement surgery, please contact the Claims Administrator for information regarding an appropriate appeal process.

If you have any questions about this letter or want to obtain an estimated annual fracture rate for a specific patient, please contact the Claims Administrator toll free at 1-800-977-0779. Someone will be available to answer questions between 9:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday. You can also contact the Claims Administrator by fax at 1-513-421-7696, or by mail at Claims Administrator, Offices of Bowling-Pfizer Trust, 525 Vine Street, Suite 1300, Cincinnati, Ohio 45202.

Sincerely,

J. Kermit Smith
Chairman
Supervisory Panel
Bowling-Pfizer Settlement

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