Medtronic Denies Charges itís Using Riata Lead Issues to Discredit St. JudeApr 10, 2012 | Parker Waichman LLP
A spokesperson for Medtronic Inc. said yesterday that the company is not running a "whisper campaign" aimed at discrediting rival, St. Jude Medical Inc. At the same time, Medtronic backed a recent study finding that the death and failure rates for St. Jude's Riata and Riata ST defibrillator leads outpaced those of its own Spring Quattro Secure leads.
The study, which was conducted by prominent cardiologist, Robert Hauser, and published in the journal Heart Rhythms, 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.
St. Jude is seeking retraction of the study, and 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"
The CEO of St. Jude said in a New York Times report published over the weekend that its rivals where engaged in a "whisper campaign" and had latched onto the Riata issue to smear its name in order to boost their sales of cardiac rhythm devices.
Medtronic has categorically denied that accusation.
"Numerous other institutions have issued case studies and manuscripts on this issue," a
Medtronic spokesperson told MassDevice.com. "This is very clearly not a marketing campaign; this is a serious issue with a device in the marketplace.”
Medtronic also said that its own analysis of the FDA database produced similar results to Hauser's.
"The conclusions we have reached about Sprint Quattro are consistent with what Dr. Hauser found, and we confirm his results related to Sprint Quattro," Medtronic said in a statement emailed to Reuters.