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.
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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.