MINNEAPOLIS, Oct. 13, 2006 (PRIMEZONE) -- Today U.S. District Court Judge John R. Tunheim granted class certification to more than 11,000 people nationwide who received one of St. Jude Medical's Silzone heart valves, enabling them to pursue their consumer fraud claims for recovery of expenses associated with the allegedly defective device. The class action consists of all persons in the United States who were implanted with the flawed device prior to St. Jude Medical (NYSE:STJ) disclosing the life threatening risks associated with the device.
Gordon Rudd, an attorney at Zimmerman Reed representing the implant recipients, responded to the Court's ruling. "These patients were implanted with a device that was never part of a wide-scale clinical trial before it was put on the market. The Court's ruling today is an important step in assuring that these individuals have a vehicle to pursue their claims as a group. As a class action, we are able to move forward to protect the interests of all affected individuals; they can now enjoy representation through this case. We are eager to continue this fight."
St. Jude Medical produced the prosthetic heart valve until announcing the recall in January 2000, in response to mounting pressure from the Food & Drug Administration (FDA). Other governments had already responded by issuing warnings or taking the devices off the market. The U.S. recall came months after tests sponsored by St. Jude showed a higher risk of paravalvular leaks at the site where the valves were implanted. Heart valves are typically surrounded on the outside by a polyester cuff called a sewing ring. The surgeon sews through this ring to stitch the artificial valve to the heart muscle. St. Jude's Silzone heart valves contained one significant variation from previous models: a sewing ring with a silver coating. Although the silver coating was designed to ward off infection, St. Jude's test revealed that the coating also greatly increased the likelihood of leaks and blood clots.
The patients' case has been difficult. In 2004, the case was certified to proceed as a class action. Upon news of the certification, St. Jude Medical appealed the decision to the 8th Circuit Court of Appeals. Last year, the 8th Circuit decertified the case and then moved the case back to the District Court to rule again on the issue. After many months of extensive briefing by the Parties, Judge Tunheim issued an order on Friday, October 13, 2006, certifying a class - and finding that individuals throughout the U.S. can assert claims under Minnesota's consumer fraud statute to obtain redress. According to David Cialkowski, an attorney at Zimmerman Reed, representing the nationwide class, "the Order is based on existing law in Minnesota; nothing has been broadened by this decision. What the Order makes clear is that if deceptive activities emanate from within Minnesota, then a Defendant like St. Jude Medical can be held accountable to individuals throughout the country under Minnesota statutes."
For more information about the case or to review the Order in its entirety, please visit www.zimmreed.com.
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca