St. Jude Medical, St. Paul, Minn., will have to go to trial to defend itself against a class-action lawsuit over a faulty heart valve marketed in the late 1990s. A U.S. District Court judge in Minneapolis ruled on Monday that the Food and Drug Administration's approval of St. Jude's Silzone heart valve in 1998 does not shield the devicemaker from liability to patients. The valve was implanted in approximately 11,000 patients in the U.S. before St. Jude voluntarily recalled it in 2000. It was coated with a silver compound in hopes of reducing infections but had the opposite effect, said Gordon Rudd, a partner at Zimmerman Reed in Minneapolis and an attorney for the patients. "The court's denial of St. Jude's summary judgment motion means that thousands of injured individuals across the country will have an opportunity to present their cases before juries," Rudd said in a written statement. At deadline, St. Jude officials had not responded to a request for comment. -- by Cinda Becker
FDA approval no shield against liability: court
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