St. Jude Silzone Heart Valves

A Ramsey County judge has ruled that claims against St. Jude Medical may proceed to trial. The plaintiffs are recipients of the St. Jude Silzone heart valves. The St. Jude Silzone heart valve was recalled in January 2000 after a clinical trial showed valves with a silver coating were prone to leak. There is also a concern that persons implanted with SilzoneAE valves face higher risks of thrombus formation, thrombosis and stroke. A thrombus is a blood clot that can form upon the valve, affecting its operation or even rendering it inoperable. Thrombosis is a condition in which blood clots form and then move through the blood stream. These clots can ultimately cause a transient ischemic attack (TIA) or a stroke due to thromboembolism.

About 36,000 Silzone valves have been implanted worldwide, about 10,500 in the United States. St. Jude indicated that while it will no longer distribute products with Silzone, it was not recommending explants of these products unless individual patient monitoring detected complications.

St. Jude urged the Ramsey County court to dismiss the cases on the basis that plaintiffs' state law claims were not permitted because the Silzone device underwent the premarket approval processes of the Food and Drug Administration. In rejecting St. Jude's argument, the Court noted that both the Minnesota and United States Supreme Courts generally disfavor what is called "preemption" of state laws. The Court also noted that plaintiffs' allegations include "claims that the defendant repeatedly violated the requirements (of federal law that govern medical devices) by among other things withholding negative clinical results, ignoring labeling requirements, and using misleading marketing information." The Court went on to say that "The contested issues of fact in this case, if found in plaintiff's favor, would result in a verdict for the plaintiffs."

Zimmerman Reed has succeeded in helping compensate those who suffer injuries caused by dangerous or mislabeled medical devices. Currently we are successfully representing patients with St. Jude's Silzone heart valves. The first cases are scheduled for trial in September 2003. If you or a loved one has a St. Jude Silzone heart valve, please click here to contact attorney Gordon Rudd by e-mail or at our toll-free number, 1.800.755.0098.