St. Jude Calls Article Inaccurate, Seeks Retraction

St. Jude claims that a recently published article that analyzed deaths tied to defibrillator leads contains "substantial errors" and a "biased analysis."

St. Jude Medical, Inc., on Friday asked for the retraction of an article that was recently published online by a medical journal, saying that it contains factual errors regarding deaths tied to defibrillator leads made by St. Jude and rival Medtronic, Inc.

The article at issue, titled “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads,” was written by Dr. Robert Hauser of the Minneapolis Heart Institute and published online by the Heart Rhythm Journal. The article includes an assessment of the number of deaths associated with Little Canada-based St. Jude's Riata and Riata ST defibrillation leads, which were recalled in 2011, compared to deaths associated with Fridley-based Medtronic's Quattro Secure leads, which are still on the market. Leads are wires that connect defibrillators to the heart.

The article based its assessment on a search of the U.S. Food and Drug Administration's Manufacturers and User Facility Device Experience database. St. Jude says it “spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser,” but its research, which looked at the same database, yielded different results. St. Jude claims that Hauser's published findings “substantially undercounted” the total number of deaths tied to Medtronic's product, resulting in “substantial errors” in the article's comparison of the two company's leads.

St. Jude said its search of the database found 377 reports of deaths involving Medtronic's Quattro Secure leads-significantly more than the 62 reported in the article. The company said it also found 74 deaths related to its products, compared to Hauser's 71.

Additionally, St. Jude claims that Hauser's report is misleading in that it looks at only one Quattro Secure lead model while accounting for all of St. Jude's Riata and Riata ST models. And the company described the direct comparison of its recalled silicone-only insulated lead with Quattro Secure, which is insulated with a polyurethane outer insulation, as “flawed.”

“Given these factual errors and biased analysis, we are requesting that the manuscript immediately be retracted by the authors and removed from online publication by the official journal of the Heart Rhythm Society,” St. Jude said in a statement.

When contacted by local media outlets, including the Star Tribune, Hauser provided the following e-mail statement: “We stand by the conclusion of study, namely: Riata and Riata ST ICD leads appear prone to high-voltage failures that have resulted in multiple deaths.” Heart Rhythm Journal editors, meanwhile, didn't respond to a request for comment from the Minneapolis newspaper.