The U.S. Food and Drug Administration (FDA) believes quality control problems at St. Jude Medical’s Sylmar, California manufacturing facility might have caused the company’s Durata defibrillator leads to be manufactured defectively. Flawed defibrillator leads can cause life-threatening side effects.
What Are Durata Defibrillator Leads?
Originally designated as the “Riata ST Optim” in 2006, St. Jude Medical changed the product’s name to “Durata” in 2008. Durata defibrillator leads are used in “implantable cardioverter defibrillator” (ICD) and “cardiac resynchronization therapy defibrillator” (CRT-D) device implantation procedures. The leads connect the heart to the defibrillator and monitor and regulate the recipient’s heart rhythms by controlling the voltage the defibrillator delivers. The leads are insulated to ensure electrical pulses from the defibrillator reach the heart muscles. The primary difference between the Riata and Durata brands is that the latter uses a polyurethane insulation over the leads.
Flawed Durata Defibrillator Leads Might Cause Life-Threatening Side Effects
Following a Class I recall of Durata’s sister product, Riata defibrillator leads, the FDA ordered St. Jude Medical to conduct post-marketing surveillance of Durata defibrillator leads to see if they showed the same defects as the recalled Riata leads did. The Riata recall occurred in November 2011 because the insulation protecting the leads corroded prematurely, affecting 79,000 people worldwide. According to the FDA’s Riata safety communication, the insulation is supposed to last for 10 years, but the FDA received reports that it was failing in as few as four years.
If the leads corrode, the conducting wires within them can “migrate” deeper into the lead or they can “externalize” outside the lead. Both phenomena can lead to ICD malfunction, which can cause the following effects:
- Abnormal sensing or pacing of the heart rhythm
- Delivery of inappropriate shocks to the heart
- Non-delivery of needed shocks to the heart
All three of these effects can be life-threatening because they can culminate in cardiac arrest.
To ensure the Durata was not causing the same side effects that prompted the Riata recall, between September and October 2012, the FDA conducted an inspection of St. Jude Medical’s Sylmar, California manufacturing facility. The agency found 11 problems with the facility’s manufacturing and quality control protocols. In December, a group of St. Jude Medical’s shareholders filed a derivative lawsuit against the company’s executives for allegedly making false statements about whether the Durata is prone to the same design flaws as the Riata.
In January 2013, St. Jude Medical’s CEO, Daniel Starks, presented at a J.P. Morgan health care conference where he claimed the facility’s problems did not negatively affect the Durata’s safety and that the company was resolving the FDA’s concerns. Days later, according to the New York Times, the FDA sent St. Jude Medical a warning letter detailing its concerns. The agency added that failure to address them could result in “seizure, injunction, or civil monetary penalties” without notice. The FDA also stated it would not approve new, similar devices made at the Sylmar, California facility or allow export requests from it until St. Jude Medical corrected the problems there.
RLG’s Durata Defibrillator Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Durata defibrillator lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Durata defibrillator lawsuit on your behalf if necessary. RLG will also keep you up to date on any Durata defibrillator class action lawsuits, additional FDA Durata defibrillator warnings, and Durata defibrillator FDA recall announcements. If you or a loved one received a Durata defibrillator and believe its leads caused an injury, contact RLG today.