Defective Medical Devices – Defective Heart Valves

Heart diseases are degenerative and valve disease refers to the condition that occurs when one (or more) of the heart valves is not working properly. Heart valves can become narrow or begin leaking, with most valve defects being mild and having little effect on the ability of the heart to pump blood. However, some heart valve problems do get worse with time and can weaken the heart and become life threatening. The only way to rectify this condition is by implanting an artificial heart valve. In fact, implanting artificial heart valves to treat valvular disease has become a common procedure in the United States.

More than 80 models of artificial heart valves have been introduced into the United States market since 1950. There are three heart valve designs on the market: the caged ball valve, the tilting disc valve and the bi-leaflet valve. There are also biologic tissue valves, from pigs, that can be used and are less thrombogenic (resulting in decreased calcification) than artificial valves, but are less durable.

All the artificial heart valves cause complications in the long-term (5 to 15 years after implantation). The primary cause is thrombosis, the calcification of the valve or the tissue around the valve. However, one of the recent high profile recall cases of a defective heart valve began in January 2000, when St. Jude Medical recalled all its valves that were coated with Silzone. The class action lawsuit claimed that the manufacturer was negligent in the design and testing of the heart valve, which caused paravalvular leakage, resulting in heart failure.