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St. Jude Silzone class action

This article was originally published in The Gray Sheet

Executive Summary

Case is filed in Minnesota federal court Feb. 11 on behalf of 10,000-14,000 Europeans with the prosthetic heart valves who may have sustained injuries following implantation between 1997 and January 2000. St. Jude already is defending a separate U.S. class action over 10,500 domestic Silzone recipients, suing for support of an ongoing medical monitoring program that would collect data on the valves and check for possible injury or side effects (1"The Gray Sheet" Jan. 12, 2004, p. 6). The firm recalled Silzone after its postmarket AVERT trial showed the coating was associated with a higher rate of paravalvular leaks than conventional valves (2"The Gray Sheet" Jan. 31, 2000, p. 16)...

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