The Bjork Shiley heart valve was initially a sure-fire hit among its recipients when it was first introduced in 1976. It was not until the modified Bjork Shiley convexo-concave (BSCC) heart valve was introduced that problems began to surface. The product was approved for use in patients by the Food and Drug Administration (FDA) in 1979, which resulted in the sale of more than 86,000 devices that were implanted in patients worldwide. Of this figure, the FDA reported that there must be an estimated 40,000 heart valves implanted in Americans alone. Because of a defect found in the valve, it was discovered that the valve had the tendency to fracture, which can cause death within minutes. From the availability of the BSCC heart valve in 1979 to 1985, there were 619 cases of reported failure of the device all over the world.

The redesigned convexo-concave models of the heart valves of Bjork Shiley were found to develop cracks, or fractures, in the struts of metal that hold the disk in place. In time, this cracked strut breaks, resulting in the disk breaking free from its hold. As a result of this, the patient would then become severely ill because of the blood that would leak back in through the valve. Approximately two-thirds of the 619 patients that suffered from the heart valves' defects died only minutes after the fracturing of the valve.

In 1986, the FDA forced the BSCC heart valve off the market because of the high prevalence of fatalities that occurred because of its defects. Pfizer, the company responsible for the production and distribution of the Bjork Shiley convexo-concave heart valves, was facing 100 lawsuits by 1990. Because of the defective valves, Pfizer had to contend with lobbying costs and legal fees that were more costly than what they would have spent to replace the valves. Pfizer spent $20 million because of the defective valves, with $10.75 million going to families of the patients who died because of the fractured valves and $9.25 going to the monitoring of those who are still living with the valves inside of them.

It is possible that you or a loved one is among those who have the defective heart valve from Bjork Shiley. If you are now concerned about your valve and wish to have it replaced, you should contact a knowledgeable lawyer on defective medical devices so your questions regarding your valve will be answered. You will also be evaluated on whether or not you have a possible case against the responsible parties, as the heart valve could fracture at any time. If you are suffering from injuries that were found to have been caused by the heart valve impanted, then your lawyer will help you to file a personal injury claim. This claim entitles you to financial retribution that will compensate for your pain and suffering as well as for the medical costs that you incurred from the heart valve's defects.

If you are a surviving spouse of a patient who had a Bjork Shiley heart valve, a lawyer could also help you in filing a wrongful death claim against the responsible parties. He will ensure that you are compensated for the medical expenses that were incurred when your partner sustained his injuries that led to his death, and the burial costs. Aside from covering these expenses, a compassionate lawyer will also make sure that the compensation you receive will provide for your and your family’s needs.