Bjork Shiley Heart Valve

The Bjork Shiley Convexo-Concave (BSCC) heart valve was a mechanical prosthesis heart valve, used to replace either mitral or aortic valves. The BSCC valve was removed from the market due to a defect that reportedly put patients' lives at risk. Following the recall of the Bjork Shiley heart valve, lawsuits were filed alleging the companies responsible for the valve hid the risks associated with it. The Bjork Shiley valve was manufactured by Shiley and was available on the market from 1979 through 1986.

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Bjork Shiley Heart Valve Failure

In 1986, the Bjork Shiley heart valve was removed from the market due to serious safety concerns. The main concern was the risk of the outlet strut on the BSCC heart valve fracturing. That fracture could reportedly cause an uncontrollable blood flow, while also releasing a mechanical disc into the patient's blood stream that could cut off the blood flow to other parts of the body.

Tens of thousands of Americans had the Bjork Shiley heart valves implanted. After the recall, not all Bjork Shiley valves were removed from patients. Because of the risk associated with removal surgery, which included an approximated death rate of about five percent, patients with weak or defective heart valves did not undergo the removal surgery, leaving the potentially defective heart valves implanted. These patients must take anticoagulation medicine, like Warfarin (coumadin) to prevent deadly blood clots.

Defects of the Bjork-Shiley Convexo-Concave heart valve have reportedly lead to sudden cardiac arrest and death. Worldwide, more than 600 valve fractures have been reported to Shiley and in approximately two-thirds of the cases, it is reported the patient died following the valve fracture.

Bjork Shiley Lawsuit

In 1991, a class action lawsuit was filed against Pfizer, on behalf of patients who had received the implant and were concerned it might fracture. The lawsuit alleged Pfizer Inc hid potential defects from patients. According to The New York Times (01/25/92), the lawsuit was settled, with Pfizer expecting to pay between $155 and $205 million total. Pfizer agreed to create a fund to pay patients for a cardiac consultation and further agreed to set aside funds for research to identify which patients had a significant risk of having the heart valve fracture.

Bjork Shiley Heart Valve failure Lawsuits

If you or a loved one have a Bjork Shiley BSCC Heart Valve that has been replaced because of a strut fracture or for safety concerns, you may qualify for damages or other remedies in a Bjork Shiley Heart Valve lawsuit or class action. Please click the link below to submit your complaint to a Bjork Shiley Heart Valve lawyer for a free evaluation.

Please click here for a free evaluation of your Bjork Shiley Heart Valve case

Last updated on May-9-12

BJORK SHILEY HEART VALVE ARTICLES AND INTERVIEWS

Phantom Employee Used to Cover Bjork Shiley Heart Valve Defects

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 [READ MORE]

Philanthropic Generosity Cold Comfort to Bjork Shiley Heart Valve Patients

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.

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Patients Hurt by Deceit in Bjork Shiley Valve Approval

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 [READ MORE]