Reuters: Regulatory News: Medical journal denies St. Jude call on article

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Medical journal denies St. Jude call on article Apr 10th 2012, 19:20 April 10 | Tue Apr 10, 2012 3:20pm EDT April 10 (Reuters) - A prominent medical journal rejected on Tuesday a public request from heart device maker St. Jude Medical Inc to retract an article that linked about 20 deaths to a malfunction of the company's defibrillator leads. Dr. Douglas Zipes, editor-in-chief of the medical journal HeartRhythm, said in an email that the article would not be retracted. In the March 26 article, Dr. Robert Hauser of the Minneapolis Heart Institute Foundation examined deaths reported in a U.S. Food and Drug Administration database, analyzing data on the Riata and Riata ST defibrillator leads, which were discontinued in December 2010 because of insulation problems. The FDA subsequently classified St Jude's advisory as a recall. St Jude called for the retraction on Friday, saying that Hauser's analysis undercounted deaths involving a rival company's lead and was therefore invalid. Last week, St Jude halted sales of two more brands of lead wires used in its cardiac resynchronization therapy devices due to worn insulation. Those products, the QuickSite and QuickFlex leads, connect to the heart a device that uses a specialized pacemaker to re-coordinate the action of the right and left ventricles in patients with congestive heart failure. St Jude shares have fallen some 12 percent in the past week. They were down 1.2 percent to $38.43 on Tuesday afternoon on a down day for the broader stock market.

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