St. Jude Silzone Discussed in Court

Toronto, CanadaA lawsuit concerning the St. Jude heart valve, recalled in 2000, has been heard in the Ontario Superior Court of Justice. The lawsuit questioned whether the Silzone mechanical heart valve, made by St. Jude, was rushed to market in an attempt to maximize profits for the device maker. The heart valve was recalled after reports of serious health problems in some patients arose.

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.

In issuing her decision, Justice Lax noted that because medical complications can occur with any prosthetic heart valves, the plaintiffs had to show that the Silzone-coated valves put patients at an increased risk of complications. "There is sufficient evidence to find (and the defendants do not dispute) that Silzone probably materially increased the risk of PVL for some patients for a period of time post implant," the judge wrote in the decision. "There is insufficient evidence to conclude that Silzone probably increased the risk of the other medical complications that are in issue and the plaintiffs did not succeed in proving that Silzone has an adverse effect on tissue healing."

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.