(PRWEB) January 24, 2013
An FDA warning letter dated January 10, 2013 to St. Jude Medical outlines several quality control issues at the St. Jude facility where the Durata and Riata leads are manufactured. The law firm McSweeney / Langevin continues to offer free legal advice to those injured by St. Jude Medical's Riata Leads.
St. Jude Medical received a warning letter from the U.S. Food and Drug Administration (FDA) concerning manufacturing practices of Durata and Riata implantable cardiac leads.
The FDA inspected the St. Jude Medical facility from September 25 through October 17, 2012 and noted five areas of concern:
First, St. Jude failed to ensure it is still following the manufacturing process originally approved by the FDA;
Second, St. Jude failed to establish procedures for monitoring and controlling the manufacturing process;
Third, St. Jude failed to establish and maintain adequate procedures for verifying the device design;
Fourth, St. Jude failed to establish and maintain a design history for for each type of device; and
Finally, St. Jude failed to establish and maintain procedures for implementing corrective action and preventive action.
The FDA went on to say St. Jude should take, "prompt action to correct the violations." According to the FDA, if these violations are not addressed, St. Jude could be subject to seizure, injunction, and civil money penalties. Finally, the FDA concluded by informing St. Jude that premarket approval for medical devices will not be granted until the above-listed violations have been corrected.
This is not the first time St. Jude Medical has been scrutinized because of its cardiac leads. 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 England 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.
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