Supervisory Panel

• David E. Miller, Chair
  • David E. Miller was appointed Chairman of the Supervisory Panel by the United States District Court on May 20, 2004. Mr. Miller is the retired Chief Probation Officer for the United States District Court for the Southern District of Ohio. He has a career of over 28 years with the Court, serving as its Chief Probation Officer from 1993 to 2004. In this capacity, Mr. Miller was in charge of the entire operation of the Probation Department including a staff of 75 people. He led and managed all aspects of the organization including: service delivery, personnel, budget, automation, liaison with the Bar, and answered directly the the Judges of the Court. Mr. Miller holds a Bachelor of Science Degree in Business Education from Miami University, Oxford, Ohio and a Master of Education in Guidance and Counseling from Xavier University, Cincinnati, Ohio.
• Joseph J. Defauw, M.D.
  • Dr. Joseph Defauw was appointed by the United States District Court for the Southern distict of Ohio as a Member of the Supervisory Panel.  Dr. Defauw is a cardiothoracic surgeon at the Antonius Hospital in Nieuwegin, the Netherlands.  He is certified by the board of the European Association for Cardio-Thoracic Surgery.  Dr. Defauw has published numerous articles related to cardiac surgery, especially in the field of surgery for cardiac arrhytmias.  He was involved in the early studies about BSCC strut fractures in the Netherlands.  Dr. Defauw earned his MD at the University of Louvain, Belgium, and completed his residency at the Antonius Hospital, Utrecht (later Nieuwegein) in 1982.
• Donald C. Harrison, M.D.
  • Dr. Harrison was appointed by the United States District Court for the Southern District of Ohio as a Member of the Supervisory Panel. Dr. Harrison is a Professor of Medicine and Cardiology at the University of Cincinnati and is Senior Vice President and Provost of Health Affairs Emeritus at the University of Cincinnati Medical Center. He was Chief of Cardiology at Stanford University for 20 years and previously served as the President of the American Heart Association. He is certified by the American Board of Internal Medicine with a Cardiology Subspecialty. Dr. Harrison has published seven books and more than 560 scientific articles and reviews. Dr. Harrison earned his M.D. at the University of Alabama School of Medicine, completed his internship at Peter Bent Brigham Hospital, and completed his residency at the Stanford University School of Medicine.
• Michel A. Ibrahim, M.D. Ph.D.
  • Dr. Ibrahim was appointed by the United States District Court for the Southern District of Ohio as a Member of the Supervisory Panel. Dr. Ibrahim was the Dean of the University of North Carolina School of Public Health and is currently Professor of Epidemiology at that university. Dr. Ibrahim received his M.D. at the University of Cairo School of Medicine. He received his MPH and PhD at the University of North Carolina, School of Public Health (Biostatistics and Epidemiology). Dr. Ibrahim has received more than 20 research and training grants from the federal government and has published two books and more than 100 editorials and scientific articles on epidemiology. His area of expertise is chronic disease epidemiology, health care research, and translating scientific evidence into clincal practice and policy guidelines.
• Tom D. Ivey, M.D.
  • Dr. Ivey was appointed by the United States District Court for the Southern District of Ohio as a Member of the Supervisory Panel. Dr. Ivey is the President of Cardiac Surgery Institute in Cincinnati, Ohio. He is certified by the American Board of Surgery and American Board of Thoracic Surgery. Dr. Ivey has published numerous articles, books and book chapters related to thoracic and cardiovascular surgery. Dr. Ivey earned his M.D. at the University of Wisconsin; completed his internship with Barnes Hospital at Washington University in St. Louis, Missouri and completed his residency at University of Washington Hospital School of Medicine in Seattle, Washington (surgery/cardiothoracic surgery.)
• Lewis Kuller, M.D.
  • Dr. Kuller, MD, DrPH is a University Professor of Public Health at the University of Pittsburgh.  He was chair of the department of Epidemiology at the Graduate School of Public Health from 1972-2002.  He is a member of the National Advisory Council on Aging at the National Institute on Aging and the National Cholesterol Education Program.  He is board-certified in preventive medicine and is a Fellow of the American College of Cardiology, the American College of Preventive Medicine and the American Epidemiological Society.  Dr. Kuller has published over 500 papers in cardiovascular diseases, women's health, aging, diabetes and cancer.  He has been the recipient of the following awards/honors: distinguished Achievement Award from the American Heart Association, the Chancellor's Distinguished Research Reward, University of Pittsburgh, and Johns Hopkins University Society of Scholars, Abraham Lilienfeld Award (American College of Epidemiology), Alumni Achievement Award from George Washington University.
• Arthur E. Weyman, M.D.
  • Dr. Weyman was appointed by the United States District Court for the Southern District of Ohio as a Member of the Supervisory Panel. Dr. Weyman is a Professor of Medicine at the Harvard Medical School, Boston, Massachusetts. He is also a physician at the Massachusetts General Hospital. He is certified by the American Board of Internal Medicine with a subspecialty in cardiovascular disease. Dr. Weyman has lectured and published numerous articles on cardiology. Dr. Weyman earned his M.D. at the New Jersey College of Medicine in Jersey City, New Jersey; and completed his internship and residency with St. Vincent's Hospital in New York.

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]