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Doctors Criticize St. Jude's Heavy-Handed Management of Rialta Defibrillator Lead Controversy

Apr 12, 2012 | Parker Waichman LLP

St. Jude's vigorous defense of its trouble Riata line of internal defibrillator leads may not be working out as well as it had hoped.  According to a report in The New York Times, some doctors have tired of St. Jude's tactics, and would rather the device maker put more effort toward helping patients with defective Riata and Riata ST. defibrillator leads.

Late last year, St. Jude recalled both the Riata and Riata ST defibrillator leads following reports that the Riata wires were poking through their insulation.  According to St. Jude, this could cause the defibrillators to inappropriately shock some patients and fail to deliver necessary therapy to others.  At the time of the  Riata lead recall, two deaths and six injuries were linked to externalized conductors.  Both patients had been undergoing procedures to remove the faulty wires when they died.

Late last month, prominent cardiologist Dr. Robert Hauser published a study in the journal Heart Rhythm which 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 the Quattro Secure, a rival lead made by Medtronic Inc. Hauser's assessment was based on a search of the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database. 

Last Friday, the company demanded the study be retracted.  St. Jude does not dispute that the insulation problem caused the Riata deaths seen in Hauser's study.  However, the company 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.  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"

The Heart Rhythm journal has refused to retract the study.  But St. Jude is continuing with its defense, and on Tuesday announced that it had posted data on the Internet intending to show Hauser had made mistakes.

The company has also claimed that its rivals have engaged in whisper campaign to discredit its products.

"This has become a topic of competitive marketing," St. Jude CEO Daniel Starks told the New York Times over the weekend. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."

According to a report published in The New York Times today, some doctors aren't impressed with St. Jude's tactics.

"I hope that St. Jude is putting as much effort into helping patients with Riata leads as they are into pointing out flaws in studies that identified the failures, Dr. Charles Swerdlow told the Times.  According to the article, the Los Angeles doctor consults primarily with Medtronic but has also worked with St. Jude.

Some doctors have also complained that St. Jude was slow to respond to the Riata problem and initially tried to play it down.  They want more guidance from the company on treating patients with the defective leads.

"In order to know what to do you have to understand the statistics,” Dr. Laurence M. Epstein, a heart device expert in Boston who consults for Medtronic and St. Jude, told the Times. “We don’t know the risks with this lead.”

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