Riata and Riata ST implantable cardioverter-defibrillator leads are prone to high-voltage failures that have resulted in death
Minneapolis, MN (PRWEB) August 14, 2012
In a manuscript sent to the Heart Rhythm Journal in March of 2012, Minneapolis cardiologist Dr. Hauser detailed his research and conclusions comparing the failure rates of the St. Jude Riata Leads to the reported failure rates of a competitor’s leads. Dr. Hauser reported 31 percent lead-related deaths for the St. Jude’s Riata Leads, and 8 percent for St. Jude’s competitors. Dr. Hauser also concludes the Riata Leads are prone to high-voltage failures that may result in death.
St. Jude Medical reacted to the Dr. Hauser article in what analysts had described as “rare,” “unprecedented,” and “confounding.” Specifically, St. Jude Medical demanded the New Englad Journal of Medicine retract the Dr. Hauser article. See Barry Meier and Kate Thomas, At St. Jude, Firing Back at Critics, N.Y. TIMES, Apr. 11, 2012, at B1; Susan Kelly and Debra Sherman, Analysis Heart device troubles cloud St. Jude’s outlook, Reuters.com, Apr. 13, 2012. Hauser's article was not retracted.
In July of 2012, St. Jude Medical released the results of its internal analysis. The data from its internal probe revealed failure rates roughly in line with the prior studies. Dr. Mark Carlson, St. Jude’s chief medical officer, did not comment on the fact the St. Jude data was in line with previous external studies. Rather, Dr. Carlson responded to this data by saying, “we are now focused on collecting longer-term data in the second phase of the study.”
St. Jude Riata Leads were recalled December 14, 2011 as part of a FDA Class I Recall. According to the FDA, medical advisers noted a higher-than-normal rate of insulation failure, called externalization. Affected model numbers include the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042). A Class I Recall is the most serious level of recall and is defined as: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
Roughly 79,000 U.S. patients have been implanted with St. Jude Riata Leads. Attorneys at the law firm McSweeney / Langevin are currently offering individuals free legal advice concerning the rights of individuals affected by Riata Leads. McSweeney / Langevin can be reached 24/7 at 1-800-888-4425.