Bjork Shiley Heart Valve

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 report of defects, 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 convex-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 valve's defects died only minutes after the fracturing occurred.

In 1986, the FDA pulled 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. Consequently, 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 lost 20 million dollars as a result of the malfunctioning device, with 10.75 million going to families of the patients who died and 9.25 to monitoring of those who are still living with the valves inside of them.

It is possible that you or a loved one are 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 who manages defective medical device cases so your questions can be answered. Your case can be evaluated free of charge. If you are suffering from health complications that were found to have been caused by the heart valve implanted, then your lawyer can help you to file a personal injury claim. This claim entitles you to financial retributions 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 or she can ensure that you are compensated for the medical expenses that were incurred when your partner sustained his injuries that led to a death. Aside from covering these expenses, a compassionate lawyer guarantees your rights are upheld, while pushing for an efficient settlement.