Detroit, MIWhen recalls of products are announced, consumers are often relieved to have a potentially dangerous product out of their home, but when products like the Bjork Shiley Heart Valve are taken off the market, patients often wind up with even greater concerns. The Bjork Shiley valve was removed from the market because of concerns about serious health risks for patients who had them implanted. The problem for patients, however, is that some patients were considered too risky for removal surgery, leaving the defective Bjork Shiley Heart Valves in their system.
Bjork Shiley heart valves were available on the market from 1979 through 1986. They were used to replace mitral or aortic valves but were taken off the market due to a risk of a component on the valve fracturing. That fracture could cause uncontrolled blood flow and could also result in releasing a portion of the valve into the blood stream, potentially cutting off blood flow to other parts of the body.
Because of the risks associated with surgery to remove the valve—the rate of death associated with the surgery was around five percent—not all patients were given surgery to remove the valve. Instead, they were put on anticoagulant medications such as Warfarin to prevent blood clots. But they spend each day knowing they have a valve that could potentially fail or fracture at any moment, putting their lives at risk.
According to The New York Times (1/25/92), the valves were implicated in approximately 300 deaths, and two-thirds of patients whose valves fracture die as a result.
Lawsuits were filed against Pfizer on behalf of patients who received the Bjork Shiley heart valve and lived with concerns that their valve might fracture. One class-action lawsuit, filed in 1991, resulted in a settlement of between $155 and $205 million. That lawsuit alleged Pfizer and its subsidiary, Shiley Inc., conspired to hide the risk of serious health problems associated with fractures of the heart valves, the Los Angeles Times (1/9/91) reports. Furthermore, the lawsuit alleged that during clinical trials of the valve in 1979 one valve fractured but no changes were made to the valves as a result of that incident.
In 1992, the FDA issued its warning about the Shiley valves, noting that the risk of fracture could be five times higher than previously thought and warning that valve fracture is often fatal.
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