St. Jude Medical (NYSE:STJ) accused arch-rival Medtronic (NYSE:MDT) of a whisper campaign to discredit its newer Durata defibrillator leads, as part of its ongoing assault against critics of its recalled Riata defibrillator leads.
Late last week the St. Paul-based medical device maker called for the retraction of a study finding a high rate of deaths related to the Riata leads. St. Jude continued the offensive over the weekend, accusing its peers of smearing its name to gain an edge in the slumping cardiac rhythm management arena.
"This has become a topic of competitive marketing," CEO Daniel Starks told the New York Times. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."
Starks and other executives also accused its Twin Cities foe of spreading rumors and breeding doubt about St. Jude’s Durata leads, according to the Times. The Durata leads use a different coating material than the Riata line and have not been associated with the same insulation issues.
St. Jude has kicked up its public statements about the Riata recall since last month’s release of a critical study published by prominent cardiologist Dr. Robert Hauser finding that the Riata devices failed more frequently than previously reported, which the company accused of "inaccurate facts and biased analysis." The device maker demanded a retraction of Hauser’s study, which culled 133 lead-related deaths from the FDA’s Maude database of medical device adverse event reports and attributed 22 to internal short circuits in the Riata leads. By comparison, Medtronic’s Quattro Secure leads, which rely on a different insulation material, were associated with 5 deaths, according to the Hauser study.
"St. Jude Medical was not consulted prior to the publication, nor asked to validate any of the data," the company said. "Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analyzing the MAUDE database that reproduces the same numbers reported in the manuscript."
But the company said it was unable to replicate Hauser’s results with its own study of the Maude database, finding 377 deaths related to the Quattro lead, compared with Hauser’s 62, and 74 deaths related to its own Riata leads, compared to Hauser’s 71.
A Medtronic spokesman called St. Jude’s allegations "false" and said the company will launch its own investigation.
"We are aware of St. Jude’s press release and are looking into the facts," Medtronic’s vice president of communications Christopher Garland told ModernHealthcare.com. "This appears to be nothing more than a difference of opinion between St. Jude Medical and Dr. Hauser."
St. Jude stopped selling the Riata leads in December 2010, after revealing a 0.47% rate of "insulation abrasion" after 9 years of use. The issue, which occurs when the lead wires poke through their insulation, can cause an interruption in the cables’ ability to sense rhythm problems in the heart and could prevent needed shock therapy or even cause unwanted shocks to a patient’s heart.
The company issued a recall in December 2011 after 2 patients died and another suffered a serious injury when surgeons attempted to extract the leads. St. Jude last week preemptively recalled its QuickSite and QuickFlex left-ventricular leads for insulation issues similar to those found with Riata but which had yet to result in any injuries or deaths.
STJ shares sagged on Wall Street today, dropping 4.0% to $39.33 as of about 10 a.m.
