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No Retraction of St. Jude Riata Defibrillator Lead Study, Journal Editor Says

Apr 11, 2012 | Parker Waichman LLP

St. Jude's bid to have a study that called the safety of its Riata defibrillator leads into question retracted was rejected yesterday by the journal Heart Rhythm.  St. Jude had said the study, which linked its Riata and Riata ST wires to 22 deaths, was inaccurate and biased.  But in an interview with The New York Times, the editor of the Heart Rhythm journal said there were no plans to pull the study.

Heart Rhythm Riata Lead Study

The study, conducted by prominent cardiologist, Robert Hauser, found that a problem with the Riata leads' silicone insulation may have been responsible for 22 deaths.  Hauser also asserted that fatalities caused by the alleged Riata malfunctions were about nine times greater than those associated with Medtronic's Spring Quattro Secure leads.  The findings were based on an analysis of adverse event reports made to a U.S. Food & Drug Administration (FDA) database.

In seeking its retraction, contends that the Riata wires are no more likely to cause this problem than other leads.  Among other things, St. Jude claims Hauser undercounted deaths associated with the Medtronic Quattro Secure lead.  According to the St. Jude statement, its own analysis of the FDA database using Hauser's criteria found 377 reports of deaths involving Quattro Secure leads, while Hauser reported 62. The company's analysis of Riata lead events in the database found 74 deaths, while Hauser reported 71. 

The company also asserts that Medtronic reported far less information regarding Quattro
Secure deaths to the FDA database than St. Jude did when it reported fatalities associated with the Riata leads.  As a result, St. Jude claims Hauser's analysis is was biased "against manufacturers that more transparently report on device malfunctions"

No Retraction, Heart Rhythm Editor Says

In an interview with The New York Times, Heart Rhythm editor Dr. Douglas P. Zipes, said that the publication had looked at St. Jude’s complaint and did not plan to pull back the article, which had undergone review by experts associated with the journal before its online publication two weeks ago.  St. Jude's own analysis had not been subject to similar scrutiny, though Zipes said he has offered the company to submit its data for review.

“I have no knowledge of their data and therefore cannot accept a statement from them to contravene the results from the peer review process," Zipes said in a separate interview with Bloomberg News.

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