The following is a brief summary of the history, development, manufacture, distribution and withdraw from the market of the 60° and the 70° Bjork-Shiley Convexo/Concave mechanical heart valves that were manufactured, distributed, sold and implanted in 86,000 humans in the United States and many foreign countries.

The Shiley Company, which was previously located in Irvine, California, started manufacturing the Bjork-Shiley Convexo/Concave mechanical heart valve in the year 1978. This specific type of mechanical heart valve was a redesign of another mechanical heart valve known as the "Shiley Radial Spherical Heart Valve" that had been previously manufactured by the Shiley Company in Irvine. The basic difference between the Bjork-Shiley Convexo/Concave mechanical heart valve (hereinafter referred to as the BSCC heart valve) and the Shiley Radial Spherical Valve was that the radial spherical valve had both the "inlet strut" and the smaller "outlet strut" welded to the flange, as compared to the BSCC heart valve which only had an outlet strut welded to the flange. (The inlet strut on the BSCC valve was created during the milling process from the same bar stock used to manufacture the flange, i.e., the ring of the valve.) Additionally, the radial spherical valve did not have a "Convexo/Concave" disc as the BSCC heart valve did. The BSCC mechanical heart valves were implanted in humans for approximately nine years between the years of 1978 and 1987.

The first BSCC valve was implanted in 1978. This first implanted BSCC valve lasted only a short period of time until September 1978, when the outlet strut fractured at both weld areas. After this valve fractured, the Shiley Company created a file known as a "Product Complaint Report," containing the results of the investigation of the cause of the fracture of this valve by Shiley and its consultants. The Shiley Company continued to manufacture BSCC valves and distribute them throughout the United States and the world for implantation in patients. These valves were made in various sizes, determined by the diameter of the "ring," which is also known as the "flange." The sizes of these BSCC valves generally ranged from a Size 21mm up to a Size 29mm. Additionally, if the valves were manufactured larger than a Size 29, then a Size 29 ring would have a "sewing ring" placed on it enabling the valve to be enlarged to a Size 31 or 33 BSCC heart valve. The sewing ring (suture ring) is made of cloth. The cardiac surgeons who implanted these BSCC valves in human hearts would place stitches through the sewing ring to sew the valve to the heart tissue to replace an injured or malfunctioning natural human mitral or aortic heart valve.

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The BSCC valves were made in two specific configurations, a 60° valve and a 70° valve. The meaning of the 60° and 70° description of a BSCC valve refers to the degree of the angle at which the outlet strut was welded on the flange. The angle degree information was recorded on the specific Shiley manufacturing records for each individual Shiley heart valve. The 60° BSCC valve was sold in the United States and Europe, and the 70° BSCC valve was sold only in foreign countries pursuant to an export permit that Shiley obtained from the U.S. Food & Drug Administration. (The U.S. Food & Drug Administration would not allow Shiley to sell the 70° BSCC valve in the United States.)

Pfizer, Inc. of New York purchased the Shiley Company in 1979. The Shiley Company continued to experience outlet strut fractures of implanted BSCC heart valves in the United States and in foreign countries. These outlet strut fractures gradually increased during years 1979 through 1996, The number of fractures decreased in the years 1997 through 2001 and continued to decrease until the present date of September 1, 2008; however, outlet strut fractures and single leg fractures of BSCC valves are still occurring and they are a very dangerous and life-threatening event.

The Shiley Company ultimately decided to withdraw the BSCC valve from the market in 1986 and stop manufacturing and distributing the valve. Approximately 86,000 BSCC valves were sold worldwide from the time Shiley began making the valve in 1978 until withdrawal from the market in 1986. The majority of these 86,000 BSCC heart valves were the 60° weld configuration while approximately 4,000 out of the 86,000 implanted were the 70° weld configuration. The 70° BSCC valves fractured at a much higher rate (seven times higher) than the 60° BSCC valves. Some of the 70° BSCC valves were manufactured by Shiley's employees grinding down the inlet strut of 60° BSCC valves so that the disc would open to a 70° angle. The date that a Shiley BSCC valve was manufactured is very important, since there have been no reported outlet strut fractures of any Shiley BSCC valves manufactured after April 1, 1984, according to Shiley, Inc. and Pfizer Inc. Most of the 60 º BSCC heart valves were manufactured at Shiley’s manufacturing plant in Irvine, California. Additionally, all of the 70º BSCC valves were manufactured in Irvine, California. However, Shiley opened another manufacturing facility in Arecibo, Puerto Rico in the year 1981, solely for the manufacture of the 60° BSCC valves.

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The 60 ° and 70 º BSCC valves were usually implanted in either the mitral and aortic positions of the heart to regulate blood flow between the heart's chambers. The BSCC heart valve has a “convexo-concave” disc located inside a metal flange ring that is covered by a sewing ring, as described above. The disc, made of pyrolytic carbon, rotates between the inlet strut that is a continuous mold of the surrounding flange as described above, and an outlet strut that is welded to the flange at the base of each of the strut legs. The material used for the inlet strut, the outlet strut and the flange is a cobalt-based alloy known as Haynes 25. The sewing ring, made of Teflon or Dacron cloth, is sutured to the heart to hold the valve in place. The disc opens to either an angle of 60° or 70°, depending on the model, to allow blood flow through the valve. The 70° valve was introduced after the 60° model allegedly to further improve blood flow through the heart; however, the 70 ° BSCC valve was never approved by the U.S. Food and Drug Administration for sale in the United States.

As stated above, the problems with the BSCC heart valve began in September 1978, when the first outlet strut fracture was noted during clinical trials of the valve. An outlet strut fracture (OSF) begins with the fracture of one of the two legs of the outlet strut, a condition known as single leg fracture (SLF). (Shiley and Pfizer refer to a single leg fracture as a “single leg separation,” i.e., “SLS”.) Valve failure occurs when the other leg of the outlet strut fractures and the disc is dislodged from the ring, resulting in unrestricted blood flow through the heart. Some medical physicians state that when this occurs, the heart does not have a heart valve to close one end of the chamber; therefore, contractions of the heart cannot force blood out of the heart. This is a form of heart failure, and it requires immediate open heart surgery. Approximately two-thirds of the people who have had an outlet strut fracture die and many survivors have serious physical injuries and other medical complications. There have been approximately 654 reported outlet strut fractures of BSCC valves as of September 1, 2008. There have been approximately 88 reported single leg fractures of BSCC valves as of January 1, 2008. Many physicians and biostatisticians believe that there have been a much larger number of outlet strut fractures that have not been reported for several reasons, including a misdiagnosis of the reasons for a death. (Many knowledgeable physicians recommend that a chest x-ray be performed immediately on a person implanted with a BSCC mechanical heart valve that has stopped ticking.)

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Between the years 1980 and 1983, BSCC valves were recalled three times by Shiley because of fractures, various design modifications, and tests. In May 1982, the first medicalphysician advisory was issued, reporting five outlet strut fractures of the BSCC valve. Shiley initiated a recall of approximately 3,900 unimplanted valves in June 1983. The Shiley Company withdrew the 70° BSCC heart valve from the market after the FDA revoked the export permit for this valve in January 1983. In November 1986, Pfizer withdrew the 60° valve from the market after findings indicated that the BSCC valve was subject to mechanical fracture, which could ultimately pose a lethal risk to implant recipients.

In summary, the history of the manufacture, distribution, sale, recalls, and withdrawal of the Shiley BSCC heart valve, including the causes of outlet strut fractures has been told in many ways. However, the actual Shiley and Pfizer documents, statements, depositions and affidavits of former Shiley employees who worked in the Shiley BSCC valve manufacturing department that are in the possession of the Johnson Law Firm speak for themselves and they show what happened and when it happened.


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