Saint Paul, MNEven though more than 12 years have passed since the St. Jude Silzone heart valve was pulled from the market, lawsuits were still making their way through the courts the past two years, including one lawsuit in Canada. The lawsuits alleged St. Jude manufactured a defective heart valve that developed a valve leak in some patients, resulting in their having surgery to remove the defective St. Jude heart valve.
In 2012, a Canadian court heard a lawsuit regarding St. Jude Silzone heart valves. The lawsuit, Andersen v. St. Jude Medical, alleged the Silzone valves, which were recalled in Canada in 2000, were unsafe. However the judge found there was not enough evidence to support the plaintiff's claim that patients' health was put at substantially increased risk because of the Silzone. Furthermore, the judge found St. Jude's conduct must be assessed based on information available to the company when the product was marketed and not information currently available.
In other words, to have been guilty of negligence, St. Jude would have had to have known at the time the heart valves were marketed that they were unsafe. Having that information at the time of the trial does not make St. Jude negligent in marketing and selling the products, the judge ruled.
St. Jude Silzone valves were different from previous valves because the sewing cuff??"the component of the valve that is actually sewn to the patient to keep the valve in place??"is coated in silver. That silver was believed to prevent infections, including endocarditis, a serious infection of the tissue surrounding the heart.
According to court documents from a lawsuit filed against St. Jude in 2001, the US Food and Drug Administration (FDA) approved St. Jude's Silzone valves for use in 1998, but prohibited St. Jude from making any marketing claims that patients who had the Silzone valves implanted would be at lesser risk of endocarditis. The reason for this prohibition was that St. Jude had not conducted clinical tests to confirm this claim.
Once the valve was approved, St. Jude began the Artificial Valve Endocarditis Reduction Trial (AVERT), to examine whether Silzone heart valves actually decreased the incidence of endocarditis. In January 2000, AVERT was prematurely halted because the independent monitoring board found patients who had the Silzone valve were more likely to experience paravalvular leak, a potentially serious condition requiring removal of the Silzone valve. According to research, two percent of the AVERT participants with the Silzone valve required removal of the valve, compared with only .25 percent of study participants who had traditional valves.
On the same day the trial was stopped, St. Jude announced a recall of all Silzone valves that had not yet been implanted.
Contrary to the findings in the lawsuit in Canada, the plaintiffs in the 2001 lawsuit alleged St. Jude hid vital safety information from the FDA and that if the FDA had that information, it would not have approved the valves for sale. The lawsuit cited here is MDL No. 01-1396: In Re: St. Jude Medical, Inc. Silzone Heart Valves Products Liability Litigation. At issue in these particular documents was a motion by the defendant for summary judgment. The court denied the defendant's motion. In 2010 an order to close the multi-district litigation was given and all cases were at the time either resolved or remanded to the appropriate courts.
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