Because they can cause serious injury or death, two medical devices manufactured by St. Jude Medical— the Riata Lead and the Riata ST Silicone Endocardial Defibrillation Lead—were officially granted U.S. Food and Drug Administration (FDA) Class I recall status in late 20111. Although St. Jude had discontinued the products a year earlier, the FDA estimates 79,000 patients still have Riata and Riata ST leads inside them.
What Are Riata Defibrillator Leads?
St. Jude Medical’s Riata Defibrillator and Riata ST Silicone Endocardial Defibrillator Leads are used in “implantable cardioverter defibrillator” (ICD) and “cardiac resynchronization therapy defibrillator” (CRT-D) device implantation procedures. The leads connect to the defibrillators and monitor and regulate recipients’ heart rates by controlling the voltage the defibrillators deliver.
Both St. Jude Medical and the FDA
Have Issued Warnings
In a December 2010 letter, St. Jude Medical informed physicians that the company was discontinuing sales of Riata Defibrillator Leads and Riata ST Silicone Endocardial Leads. The company followed up in November 2011 with a “Physician Advisory Letter” to doctors informing them that the conductors in those devices because could become “externalized” through abrasions in the wires’ silicone insulation—a condition that could prevent the defibrillator from delivering the electrical impulse the heart requires, or worse, cause the defibrillator to deliver excessive voltage. Both events can cause injury, cardiac arrest, and death.
The FDA doesn’t technically recall drugs itself; the agency issues recall requests to companies, publicizes recalls, and classifies recalls. On December 15, 2011, the FDA classified St. Jude Medical’s November 2011 Physician Advisory Letter as a “voluntary Class I Riata Defibrillator Lead recall.” A Class I recall is the most serious of the agency’s classifications.
On August 16, 2012, the FDA issued a Riata Leads Safety Communication advising all Riata and Riata ST Lead recipients to undergo either two-view x-rays or fluouroscopy to determine if their leads show signs of insulation breaches that might cause injuries.
Riata Defibrillator Leads Might Cause Injury or Death
According an October 2012 Wall Street Journal article, some doctors report having encountered abrasion problems with the St. Jude leads in their own practices “between 2006 and 2009. When these doctors brought the incidents to the attention of St. Jude they say they were told by company officials and field representatives that the incidents were isolated.”
A study of 212 recipients of Riata and Riata ST Leads showed that 15% of them had “insulation breaches,” which cause wire externalization and the accompanying side effects of inadequate or excessive voltage discharges, according to a Minneapolis Star Tribune article. In April 2012, the New York Times cited research showing that defective Riata Defibrillator Leads played a role in 20 patients’ deaths.
RLG’s Riata Defibrillator Lead 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 more trouble to be made whole again.
The Riata Defibrillator Lead 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 of helping you to recover they money you’re due, and we will file a Riata Defibrillator Lead lawsuit on your behalf if necessary.
If you received Riata Defibrillator Lead with your defibrillator and you believe it harmed you, contact RLG today by filling out the form on this page.