St. Jude Disputes, Demands Retraction of Riata Defibrillator Lead StudyApr 9, 2012 | Parker Waichman LLP
St. Jude Medical is disputing findings from a recently published study regarding deaths caused by high voltage failures of its Riata and Riata ST defibrillator leads. In a statement issued by the company on Friday, St. Jude asserts the Riata study, authored by prominent cardiologist Dr. Robert Hauser, is inaccurate and biased. The company has asked the Heart Rhythm Journal, which published the Riata lead study last month, to retract it.
The study 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 the Quattro Secure, a rival lead made by Medtronic Inc. Hauser's assessment was based on a search of the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database.
St. Jude does not dispute that the insulation problem caused the Riata deaths seen in Hauser's study. However, the company 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 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. St. Jude said it used the same criteria as Hauser had in performing its analysis.
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"
Late last year, St. Jude recalled both the Riata and Riata ST defibrillator leads f reports that the Riata wires were poking through their insulation. According to St. Jude, this could cause the defibrillators to inappropriately shock some patients and fail to deliver necessary therapy to others. At the time of the recall, two deaths and six injuries were linked to externalized conductors.
The problem that prompted the recall is separate from the insulation issue seen in Hauser's study. Hauser reported no Riata deaths linked to exposed wires.