The FDA inspected St. Jude’s manufacturing plant in Sylmar, California, and discovered 11 problems with the Durata lead. Several of these problems stemmed from deviations from standard manufacturing processes. In five cases, St. Jude failed to properly address these issues. It also failed to establish adequate procedures to confirm the design and construction of the device. The company only tested the lead one time, rather than the required five tests in internal processes.
Riata defibrillator lead
The lawsuit against St. Jude Medical for its Riata defibrillator lead was filed in April by Richard Connelly, a man who was implanted with the device in 2003. The device allegedly malfunctioned between 16 and 20 times while Connelly was sleeping, causing irreparable harm. In his lawsuit, Connelly claimed strict liability for manufacturing defects, negligence per se, and failure to warn of the potential risk. However, St. Jude denied the claims, arguing that they were preempted and not sufficiently pled.
Defibrillator leads containing Durata and Riata have similar defects. Riata was recalled in November 2011 and St. Jude has stopped selling the product. The faulty leads led to inside-out erosion – the inner conductor wires wore away against the external insulation. This caused the conductor to become externalized and the patient died. The Durata, however, had few reports of inside-out abrasion and dozens of reports of outside-in abrasion – in which the lead rubs against other devices and erodes the lead.
Durata lead wire
One Arizona resident suffered from the deadly consequences of a St. Jude Durata lead wire. The wire connects an implantable defibrillator to the heart. The Durata lead wire has fraying problems and could fail to deliver shocks at the correct time. In addition, patients could suffer serious injuries or death if the wire is exposed. The company’s response has been insufficient. The case is currently in litigation, but the Phillips Law Group is monitoring the situation closely.
The Durata lead was developed to address the problems of the recalled Riata ST leads. It has the smallest diameter high-voltage lead currently available in the market. Small diameter leads can help patients with narrow veins or inadequate blood flow. The Durata lead has a flatware design to prevent tissue ingrowth and double-redundant cables for enhanced reliability. It also features 17 and 21-cm shock coil spacing.
High-voltage shorts
In the Riata leads lawsuit, a high-voltage short was found in nearly 93% of the pacemaker leads. The high-voltage short occurred on the wiring between the proximal and distal right ventricular coil cables and the sensing conductor. These leads were also susceptible to abrasion, and a quick shock or alert may not indicate a potential short. Despite this, a lawsuit filed against Abbott and Durata lead manufacturers continues to delve into the cause of high-voltage shorts.
The Durata lead failures were first discovered in 2010 when St. Jude pulled the silicone-coated pacemaker leads. By November of that year, the company had also warned that leads appeared to fail more frequently than previously reported. FDA officials eventually ordered a recall of Riata leads, and the company settled the product liability lawsuits. As of December 2010, St. Jude has ceased selling Riata leads and is no longer accepting new claims relating to them.
Insulation failures
The Insulation Failures in Durata Leads lawsuit involves numerous cases of premature abrasion and externalization of conductors. The failures occurred during the implanting of the leads, resulting in a risk to the patient. The lead manufacturer SJM acknowledged the problems in its product performance report published in November 2011. The SJM study found that 15 percent of Riata leads were abraded, with one case of an externalized conductor. A similar study found that 99.9% of Dura-ta and Riata ST leads did not exhibit abrasion or externalization of conductors.
However, the Defendants’ fraud-by-hindsight argument is not persuasive because the ACC alleges that SJM’s IESD and CRMD facilities had a pattern of quality system deficiencies that extended to the manufacturing of the silicone-insulated leads and Durata. The Defendants’ January 2013 Warning Letter and Form 483s document the alleged deficiencies, making them relevant to the lawsuit. The January 2013 Warning Letter confirms that the defendant should have known of the defects during the class period.
St. Jude Riata lead
The recall of St. Jude Riata leads has prompted many individuals to file St. Jude Riata lead lawsuits in California and Minnesota. These lawsuits allege that the recalled lead product failed to warn patients of the risks associated with these medical devices. This lawsuit may be the only way for the recalled lead products to be replaced. However, the website does not accept new cases, so if you were injured by one of the leads, you may want to file a claim.
The St. Jude Riata lead lawsuit cites design defects in the Riata ST leads that caused the premature failure of Loiseau’s lead. The faulty wiring in these leads exposed them to the body, increasing the risk of unnecessary shocks and a failure to deliver a life-saving shock. The lawsuit alleges that St. Jude did not adequately warn physicians and patients of the risks associated with the Riata lead and failed to fix the problem.