According to the lawsuit, Andersen v. St Jude Medical, Inc. (court file no: 00-CV-195906CV), the plaintiffs alleged that St. Jude, "failed to reasonably evaluate the utility and safety of Silzone before introducing it to the market and then failed in their duty to warn of the risks." The lawsuit, a class action involving around 1,100 patients, was represented by two patients who received a Silzone heart valve.
The Silzone heart valve was a mechanical prosthetic heart valve that included a coating with layers of titanium, palladium and metallic silver. Silver is antimicrobial and is used to prevent the growth of bacteria, which can cause serious complications in patients who have heart valve surgery. The Silzone heart valve was available for use in Canada from September 1997 through January 21, 2000, but was subject to a worldwide recall after a trial (called the AVERT trial) suggested an increased risk of paravalvular leak (PVL) requiring removal of the valve from some patients.
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Finally, in dismissing the lawsuit, the judge noted that the plaintiffs did not show failure on the part of the defendants to execute a reasonable degree of care in their design and testing or surveillance of the Silzone products. But the judge did note that the Silzone heart valve was associated with an increased risk of PVL, which was not at issue in the lawsuit.