St. Jude Medical Calls for Retraction of Riata Study

The St. Jude Medical Inc. Riata lead controversy is not going away. Robert G. Hauser, M.D.’s study of the cardiac defibrillator lead wires published in Heart Rhythm Journal (HRJ) elicited dissent from St. Jude when it was published in March. The study found the company’s Riata leads to be the cause of 22 deaths (St. Jude claims that number is actually only 20) due to the lead wires’ tendency to externalize from their insulation. St. Jude is now calling for HRJ to retract the study, citing inaccurate facts and bias. This comes after the recall of the Riata leads in December of last year, and an advisory letter about its QuickSite and QuickFlex leads St. Jude sent out earlier this year.

Embroiled in the controversy is Hauser, whom St. Jude is accusing of being biased toward the company’s competitor, Medtronic Inc. Medtronic is the producer of Quattro Secure, lead wires that perform the same function as the Riata leads. Hauser found that only five deaths were directly caused by Quattro leads, which St. Jude contends is a biased finding. Daniel Starks, CEO of St. Jude, told the New York Times that St. Jude has been “more transparent than [other companies]” about its leads, insinuating that Medtronic has not. This, Starks suggested, simply makes St. Jude look worse than their competitors, and may have affected the study. Starks also suggested, along with other executives, that Medtronic has begun a “whispering campaign” about its other product, the Durata lead.

St. Jude has had the Durata lead on the market for several years now. It claims that the Durata has an extra coating of insulation that prevents wire exposure.

Medtronic, for its part, told Medical Product Outsourcing that these accusations from St. Jude are not new.

“From the very beginning of their issues with their leads, St. Jude has been making claims that this is nothing more than a marketing campaign by Medtronic. However, the timeline of events clearly tells a different story,” said Medtronic spokesperson Christopher Garland.

Some experts have found that St. Jude has been less than forthcoming about the risk of its products. St. Jude’s advisory letter to physicians in 2010 stated a 0.47 percent chance of Riata wire exposure, while other researchers independent of the company put that number closer to 30 percent. A summer 2011 paper published by physicians in Northern Ireland cited a 15 percent Riata failure rate. That November, St. Jude issued another letter providing “updated estimates of failures” of Riata leads.

“They have at multiple steps underplayed the gravity of the situation,” said Kenneth Ellenbogen, M.D., medical device expert and chairman of the division of cardiology at the Virginia Commonwealth University Pauley Heart Center in Richmond, Va. He is a sometime consultant for St. Jude and its competitors.

In an attempt to demonstrate transparency while simultaneously revealing what it sees as bias in Hauser’s study, St. Jude independently searched the U.S. Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience Database (MAUDE), the device database Hauser used to gather information. The company found 74 Riata lead-related deaths, while Hauser reported finding only 71 (related deaths are different from deaths directly caused by the device). At the same time, St. Jude claims it found 377 Quattro lead-related deaths, while Hauser reported only 62. St. Jude also points out that the comparison between Riata and Quattro leads is an unequal one, considering the two leads are insulated by different materials—Riata leads by silicone and Quattro leads by polyurethane. Finally, St. Jude notes that the FDA specifically states on its website that MAUDE is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices,” making Hauser’s use of the data, according to the company, inappropriate. Further, the FDA includes a disclaimer that states the reports submitted to the database “[do] not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event.”

Despite these disclaimers, a quick search of the HRJ database shows that it is not uncommon for researchers to use MAUDE as a tool for research.

St. Jude Medical said in a statement that the company has spent more than 300 hours trying to replicate the numbers Hauser came up with in his study, but hasn’t been able to. St. Jude found “duplicate reports, inconsistent categorizations and failures to include all available reports.”

Late Monday evening, HRJ rejected the request for retraction, citing that the article in question had undergone review by experts before publication.

St. Jude Medical, based in St. Paul, Minn., is focused on cardiac, neurological and chronic pain devices. Medtronic Inc. is based in Minneapolis, Minn., and is one of the industry’s largest firms, focused on the cardiovascular and spinal sectors.