St. Jude Softens Stance on Riata Defibrillator Lead Study Author

It appears that St. Jude Medical Inc. has softened its criticism, somewhat, of Dr. Robert Hauser, the prominent cardiologist and researcher who recently linked the company’s recalled Riata defibrillator leads to 22 deaths. According to MedCity News, St. Jude’s CEO, Daniel Starks, was more conciliatory towards the researcher a during conference call yesterday to discuss the company’s quarterly earnings. However, he still maintained that Hauser’s Riata lead study, which was published last month in the journal HeartRhythm, was riddled with errors.

“Let me just start by saying that very sincerely we have a lot of respect for Dr. Hauser’s contribution over the years to raising awareness about medical device safety issues. We have far more in common than not. We are both focused on patient safety. We are both focused on getting as much accurate information about medical devices’ performance to physicians as possible to help them make the best decisions about their patients,” Starks said. “Unfortunately the HeartRhythm Journal published the manuscript submitted by Dr. Hauser contained important errors that were not identified during the peer review process and were widely circulated and really this just put everyone in an awkward position.”

The Riata and Riata ST defibrillator leads, which are wires that connect implantable defibrillators to a patient’s heart, have raised safety concerns for several years now. St. Jude stopped selling the Riata in late 2010, and warned doctors not to use them because they were poking through their insulation. Such a defect can cause a defibrillator to emit unnecessary shocks to a patient’s heart, and even worse, fail to emit a life-saving electrical impulse to the heart when it’s needed. In December 2011, the U.S. Food & Drug Administration deemed St. Jude’s action a Class I medical device recall.

Hauser’s HeartRhythm study analyzed 62 lead-related deaths for Medtronic Inc.’s print Quattro Secure and 71 for Riata. Out of those, Hauser determined 22 deaths to “high-voltage” failures caused by insulation defects in Riata Leads, but only 5 to similar Quattro Lead failures. The deaths in Hauser’s study were obtained via a search of the FDA’s Manufacturers and User Facility Device Experience (MAUDE) database.

St. Jude forcefully disputed Hauser’s findings, calling his study biased and inaccurate. The company further claims its own analysis of the FDA data using the same criteria employed by Hauser found 377 reports of deaths involving Quattro Secure wires, versus his 62. The company’s analysis of Riata lead events in the database found 74 deaths, while Hauser reported 71.

St. Jude demanded retraction of the HeartRhythm study. However, the company also launched a media blitz in which Starks accused the company’s competitors of engaging in a “whisper campaign” against it, and of using the Riata issues to discredit its newer Durata defibrillator lead wire.

By last week, however, it appeared that St. Jude’s campaign to defend the Riata was not having the desired effect. HeartRythm ultimately rejected the retraction request. Even worse for the company, many in the medical community questioned St. Jude’s heavy-handed tactics.

“I don’t think he (Stark) is helping his company,” Dr. Laurence M. Epstein, a heart device expert in Boston who consults for Medtronic and St. Jude, recently told The New York Times. “I think that any time you get defensive, it looks bad.”

Now it appears that such criticism may have chastened St. Jude somewhat, and Starks took a much more conciliatory approach when speaking of Hauser’s study yesterday.

“Keeping in mind that this information is about life-saving medical devices, it’s important for us to continue to inform patients with the most accurate information that we can and continue to inform physicians, Starks said. “So we are now working with the Heart Rhythm Journal to address this issue in a way that will be most helpful for patients and physicians and we think that’s important for us to do so.”

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