David vs. Goliath: St. Jude Medical seeks retraction of Heart Rhythm Journal manuscript

April 9, 2012 by MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

St. Jude Medical, a widely-used manufacturer of implantable cardiac devices, finds they have a bit of a problem with a form of insulation that surrounds wires contained in several lines of their pacing and defibrillator leads.  They decide to pull these products from the market after substantial evidence that their leads' reliability falls below their standards.  

A credible doctor, Robert G. Hauser, MD, known for his work in reviewing medical device safety issues, published a perspective piece critical of the post-market surveillance of the Riata leads in the New England Journal of Medicine.  St. Jude Medical takes issue with Dr. Hauser, and publishes a rebuttal in the same issue of New England Journal of Medicine.

Dr. Hauser then submits a paper to the scientific peer-reviewed Heart Rhythm Journal for publication.  The paper reveals deaths that might be caused by St. Jude Medical's faulty leads.  The reviewers feel it is an important paper to share with their readership.  The paper is published

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Today we find that St. Jude Medical is REALLY not happy with Dr. Hauser and demands that his paper be retracted from the Heart Rhythm Journal on the basis of their competitor's lead data reliability that they feel was misreported.  The same letter fails to mention their own quality issues.