NOTICE: The supervisory panel has recently published an article in the American Journal of Cardiology entitled "Bjork-Shiley Convexo-Concave Heart Valve Experience from the Perspective of the Supervisory Panel". The 20-year activities of the medical supervisory panel appointed under the terms of a settlement agreement of the Bowling v. Pfizer suit involving the Bjork-Shiley convexo-concave heart valve are detailed. The article is provided in its entirety on this website by clicking on "Key Documents".
In 1992, Pfizer Inc. and Shiley Incorporated, a wholly owned subsidiary
of Pfizer Inc., negotiated a settlement with members of the Bowling class
in the case called Arthur Ray Bowling, et al.
v. Pfizer Inc., et al., C-1-91-256, United States District Court
for the Southern District of Ohio, Western Division, currently assigned
to the Honorable Herman J. Weber.
The Bowling class members were recipients of a mechanical heart valve
manufactured by Shiley known as the Björk-Shiley Convexo-Concave
(BSCC) who claimed that the heart valve was defective due to a small,
but potentially catastrophic risk of strut fracture. The class is
defined under the settlement agreement (.tif
format - .pdf format)
as "all living persons currently implanted with C/C heart valves
and their current spouses" as of January 23, 1992, except those persons
who opted out (excluded themselves) from the class.
Guidelines have been developed to determine
which patients with Björk-Shiley Convexo-Concave heart valves will
be compensated from the Settlement for their valve replacement surgery.
The guidelines are based on a comparison of the risk of the operation
to replace the valve with the risk of fracture if the valve is left in
place. If the risk of valve fracture exceeds the risk of reoperation,
the class member qualifies for monetary benefits.
As part of the Bowling Settlement, Pfizer and Shiley agreed to deposit
money into certain funds. This web site is presented by The Special
Masters/Trustees for the Bowling-Pfizer Heart Valve Settlement Funds and
the Supervisory Panel to provide information about the settlement. The
Trustees have placed on this web site information concerning the settlement,
including the Trustees' semi-annual reports,
which allow interested people to read about this settlement's progress
since its inception.
Additional information on heart valves and/or heart valve research can
be found by clicking on more information.