Supervisory Panel

Bowling-Pfizer Settlement Funds

525 Vine Street, Suite 2300
Cincinnati, Ohio 45202-3124
(800) 977-0779
(513) 421-7696 (fax)
bowlingpfizer@fuse.net

Supervisory Panel

David E. Miller, Chair

Joseph J. Defauw, M.D.

Donald C. Harrison, M.D.

Michel A. Ibrahim, M.D. Ph.D.

Tom D. Ivey, M.D.

Lewis Kuller, M.D.

Arthur E. Weyman, M.D.

The Supervisory Panel was created to administer the Patient Benefit Fund. It is comprised of six physicians with worldwide reputations as scientific or medical experts plus a successful business person as Chair. The Supervisory Panel has three main duties:

(1) to conduct research on techniques to identify implantees with a significant risk of strut fracture and research on reducing the risk of valve replacement surgery;

(2) to develop guidelines for the replacement of high risk valves due to risk of strut fracture; and

(3) to create a publicly accessible repository of information useful to the medical community.

The Patient Benefit Fund is used, in part, for the payment of expenses for surgery to explant, due to risk of a strut fracture, a class members' heart valve and replace it with another prosthetic valve so long as the surgery is in compliance with certain guidelines. Other benefits are provided under the Settlement Agreement that are paid by Pfizer.

In 1997, the Supervisory Panel adopted and the Court approved Guidelines to Assess Patients with Bjork-Shiley Convexo-Concave Heart Valves for Elective Explantation. The 1997 Guidelines were adopted after the Supervisory Panel had monitored a number of clinical studies, analyzed the worldwide database for BSCC valves, studied manufacturing records and undertaken extensive studies to understand the operative risk of elective explantation as it relates to age and cardiac functional ability. Expert cardiovascular surgeons, cardiologists, biostatisticians, epidemiologists and ethicists evaluated newly available data and formulated recommendations for the Supervisory Panel's Guidelines. The 1997 Guidelines were based on epidemiologic findings as there was no diagnostic technique for the direct, physical identification of a high risk valve. Since 1997, the Supervisory Panel's research and work has continued.

On March 8, 2000 the Court approved the Amended Guidelines to Assess Patients with Bjork-Shiley Convexo-Concave Heart Valves for Elective Explantation proposed by the Bowling-Pfizer Supervisory Panel. [see: Guidelines]