As you may recall from reports in previous issues, the U.S. Food and Drug Administration (FDA) issued a St. Jude Riata recall in December 2011. The action was taken in response to several warning letters sent by St. Jude to doctors about reports of problems with the insulation surrounding the wire, which can become worn and allow the heart defibrillator wires to become externalized. Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that approximately 79,000 of the leads remain active in patients in the United States.
Because the process of removing the lead is very risky, doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed. In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.
The FDA has ordered the company to conduct additional studies on the potential risk of insulation failures and problems with the defibrillator leads, including the newer versions sold under the Riata ST Optim and Durata names. A growing number of individual St. Jude Riata lead lawsuits have been filed throughout the country by individuals who have experienced problems. A class action lawsuit filed on behalf of St. Jude Riata lead recipients seeks compensation for medical monitoring and other damages caused, even if the lead has not malfunctioned.
A recent study published in the medical journal Heart Rhythm suggested that about 11 percent of the St. Jude Riata leads may suffer insulation failure after five years. For more information on this subject, you can contact Melissa Prickett, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.