The Bjork Shiley Heart Valve was a problematic medical device that was pulled from the market years ago after problems began surfacing with an outlet strut that became fracture-prone. Also known as the Bjork Shiley BSSC, the Bjork Shiley valve was pulled from the market following hundreds of deaths that were thought to have stemmed from the failure.
But devices can and do fail.
William O'Neill, a cardiologist with the University of Miami, said in comments published in the Miami Herald last year (2/5/11) that the Bjork Shiley heart valve failed in only one percent of patients—and that 20 percent of patients requiring heart valve replacement died within six months of diagnosis if the valve replacement was not performed.
"That's what people don't understand," O'Neill said. "There is no medical device that is foolproof. Nothing made by man will be 1,000 percent safe."
The co-inventor of Bjork Shiley heart valves, Donald P. Shiley, studied engineering at the University of Portland and came up with the initial concept of the valve primarily on his own, before working to improve the design with Sweden's Viking Bjork, a heart surgeon from that country.
Shiley would later sell his company, Shiley Laboratories, to Pfizer Inc. It was Pfizer that bore the brunt of many a Bjork Shiley lawsuit following allegations that Pfizer hid potential defects allegedly inherent with the heart valve from patients. An expected settlement payout of between $155 and $205 million was to have been augmented by funds set aside for research to determine which of the Bjork Shiley patients were at significant risk of heart valve fracture.
That doesn't include those patients having to live with the fear that their heart valve could fracture at any moment—fear that could significantly impact the quality of life for a patient.
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Following Shiley's death in 2010, his widow Darlene continues Shiley's philanthropic ways. This year she gave $1 million to the Masterpiece Trust, a fund associated with PBS television. According to The New York Times Blogs (3/29/12), it is the largest single donation the Trust has received.
Such generosity may come as cold comfort for any patient continuing to battle, either physically or emotionally, with defective Bjork Shiley heart valves. Meanwhile, critics of the US Food and Drug Administration (FDA), such as the advocacy group Public Citizen, continue to rail against the Administration that it remains too lax in its approval protocols.