The problem is what to do about the patients who may still have functioning Bjork Shiley heart valves pumping away in their chests. The estimate was 55,000 in 1990. There are likely fewer today. But anyone still with one of those heart valves beating in their chests will forever wonder if, and when it might fail.
A failure of the Bjork Shiley BSCC can be catastrophic—especially if the device fractures at one of the welds. The unrestricted blood flow can cause death in under an hour, if not minutes if left untreated.
The Times article, first published April 17, 1990 referenced 389 fractures of the Bjork-Shiley convexo-concave heart valve since 1979. Of those fractures suffered by patients worldwide, death resulted in two out of every three cases.
It's one of the reasons why the problematic valve was removed from the market in 1986. Critics are quick to blame Shiley Inc., the company that developed and marketed the valve, for an inferior product. But there are other factors at play, including a regulator that, it has always been assumed, took action to pull the valve from the market.
According to the Times article, the US Food and Drug Administration (FDA) did no such thing. Various officials within the FDA, it has been reported, urged the agency to order the valve off the market. But the FDA deferred. In reality, the FDA is reported to have taken no official action until 1986—the year the Bjork Shiley Convexo-Concave valve disappeared from the market—and that was only to announce a review of the troubled valve in light of growing problems.
In reality, the Bjork Shiley valve was voluntarily removed from the market by the manufacturer itself citing, according to the New York Times, negative publicity. Regulators, it was reported at the time, acknowledged to Congressional officials that their response was found to be lacking, and that the FDA should have acted sooner.
Any would-be plaintiff thinking of filing a Bjork Shiley lawsuit due to problems with an original heart valve might be well served to look beyond the manufacturer in seeking a smoking gun.
Bjork Shiley heart valves were originally developed by noted Swedish surgeon and scientist Dr. Viking O. Bjork, and engineer Donald P. Shiley, who founded Shiley Inc., the manufacturer and marketer of the heart valves. Both men have since passed away, and the widow of Donald Shiley, Darlene, now spends her time as a philanthropist donating millions of dollars to worthy causes.
Shiley Inc. was purchased by Pfizer Inc. in 1979.
READ MORE BJORK SHILEY HEART VALVE LEGAL NEWS
Bjork Shiley lawsuits allege that proponents of the manufacturer were negligent in not communicating emerging problems with the device to the medical community, or the general public. A class-action lawsuit against Pfizer Inc. was settled in early 1992, with the defendant facing millions of dollars in settlement claims. For any patient who may have survived a Bjork Shiley BSCC strut fracture and required revision surgery to have the valve replaced, it may not be too late to pursue a damage claim.