Bjork Shiley Heart Valve Legal News Articles & Interviews

Washington, DC Issues with defective devices such as the Bjork Shiley Heart Valve bring to mind problems with the device itself. But how a company handles serious issues, such as problems with the Bjork Shiley valve, can add to the defective nature of the product. As issues with the defective Bjork Shiley heart valves grew in severity, claims arose that Shiley??"manufacturer of the valve??"was misleading patients and the FDA about its device.

New York, NY With the Bjork Shiley heart valve removed from the market in 1986, it makes sense to think that all lawsuits related to the Bjork Shiley valve would already have been filed and cleared from the courts. And indeed, some Bjork Shiley lawsuits have been settled. But that does not mean that people who suffer a failure of the Bjork Shiley valve today could not file a lawsuit.

Washington, DC Deep in the bowels of an archive maintained by the New York Times is a compelling investigative piece that aims to shed light on the Bjork Shiley Heart Valve, a mechanical device removed from the market in 1986 after too many patients experienced problems with the device. Many, numbering in the hundreds, died.

Cleveland, OH When it comes to analyzing the catastrophe that was the Bjork Shiley Heart Valve situation, it took some analysts a while to give in-depth analysis of the situation. The Bjork Shiley valve was removed from the market in 1986, but even in 2005 experts were asking if the problems experienced with the Bjork Shiley heart valves could happen again.

Washington, DC Nearly ten years after the Bjork Shiley Convexo-Concave heart valve was withdrawn from the market, Professor John H. Fielder authored an exhaustive analysis of the troubles associated with the allegedly problematic medical device, and what the market withdrawal might have really meant.

Seattle, WA It seems only natural that a patient assumes when a device is implanted in him—especially when that device is intended to be life-saving—that the device itself is free from defects. But according to a decades-old report by The New York Times (3/21/92), some Bjork Shiley heart valves may have been cracked and improperly sealed when they were implanted, putting some recipients of the Bjork Shiley valves at risk for serious complications, and even death.

Chicago, IL When patients receive a medical device such as the Bjork Shiley Heart Valve, they probably assume the device was properly manufactured and the company that made it followed all relevant regulations in producing the device. But Bjork Shiley lawsuits from just after the Bjork Shiley valve recall was announced, suggest that the company involved in making the valves hid the dangers from patients until the FDA intervened.

Alexandria, VA It may be cold comfort for anyone who possesses a medical device—of any design or any form—to learn that medical devices are far from perfect. While patients like to think they are, the manufacturers and the industry know better. For those in the know, therefore, actions such as a Bjork Shiley lawsuit are not surprising.

San Diego, CA When Donald P. Shiley, co-inventor of the Bjork Shiley Heart Valve died in 2010, the Los Angeles Times (8/7/10) covered his death. Shiley had suffered failing health not related to the Bjork Shiley heart valves that he helped create. But the Los Angeles Times article noted that fewer than 10 years after the valve was approved for sale, the US Food and Drug Administration (FDA) forced a Bjork Shiley valve recall.

Detroit, MI When 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.