Lawsuit Filed Over Failed St. Jude Riata Defibrillator Lead

A product liability lawsuits has been filed by a Washington, D.C. man whose St. Jude Riata defibrillator lead failed, joining a growing number of complaints filed by individuals throughout the United States who have experienced similar problems with the recalled lead wires.

The complaint (PDF) was filed by Gary Rouse in the U.S. District Court for the District of Minnesota on September 17, naming St. Jude Medical and Pacesetter, Inc. as defendants.

According to the lawsuit, Rouse received a St. Jude Riata lead in 2008, connecting his implantable defibrillator to his heart. However, he learned in July 2012 that the Riata lead was failing and he has had to undergo surgery near his heart to replace the defective lead.

A St. Jude Riata and Riata ST defbrillator lead recall was issued late last year, after the medical device manufacturer stopped selling the leads amid reports of the lead conductors poking through the insulation. If the leads penetrate the insulation, the wire can become exposed inside the patients’ body, posing several risks for patients. 

Although St. Jude stopped selling the Riata leads and issued the recall, patients like Rouse were left with few options, since removing the leads, which are inserted through arteries leading to the heart, can be difficult and dangerous.

Last month, the FDA recommended that any individuals who received a St. Jude Riata or Riata ST lead obtain an x-ray or other imaging exam to check the condition of the leads.  The agency also recommended that doctors consider remote monitoring of patients with the recalled leads to quickly catch any electrical problems.

St. Jude was also ordered by the FDA to conduct new clinical studies on other defibrillator leads, including the newer St. Jude Riata ST Optim and St. Jude Durata leads.

At least three other St. Jude Riata lead lawsuits have been filed in the U.S. District Court for the District of Minnesota by individuals who had to have their leads replaced because of design defects.