MINNEAPOLIS, Jan. 6, 2004 (PRIMEZONE) -- Judge John R. Tunheim, U.S. District Court, ruled that FDA approval is not enough to shield St. Jude from its responsibility to injured heart valve patients. The Court ruled that St. Jude could be held accountable for injury claims despite initial FDA approval of the medical device. According to Gordon Rudd, 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."
St. Jude Medical, Inc., (NYSE:STJ) has headquarters and manufacturing facilities in Minnesota. They received FDA approval for commercial distribution of an artificial heart valve with a sewing cuff coated with Silzone, a silver compound, in 1998. Since that time, thousands of people across the country with heart valve problems have turned to St. Jude Medical's Silzone valves in hope of a solution. Unfortunately, St. Jude's premium Silzone valve not only failed to improve treatment, but also created additional problems. In January 2000, a multi-national clinical trial revealed that patients with the Silzone valve were more likely to experience paravalvular complications than patients with other valves. Such complications usually necessitate additional surgery to remove and replace the valve.
A copy of the District Court's Order is available at www.zimmreed.com.